case study of protocol

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Introduction, contents of a research study protocol, conflict of interest statement, how to write a research study protocol.

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Julien Al Shakarchi, How to write a research study protocol, Journal of Surgical Protocols and Research Methodologies , Volume 2022, Issue 1, January 2022, snab008, https://doi.org/10.1093/jsprm/snab008

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A study protocol is an important document that specifies the research plan for a clinical study. Many funders such as the NHS Health Research Authority encourage researchers to publish their study protocols to create a record of the methodology and reduce duplication of research effort. In this paper, we will describe how to write a research study protocol.

A study protocol is an essential part of a research project. It describes the study in detail to allow all members of the team to know and adhere to the steps of the methodology. Most funders, such as the NHS Health Research Authority in the United Kingdom, encourage researchers to publish their study protocols to create a record of the methodology, help with publication of the study and reduce duplication of research effort. In this paper, we will explain how to write a research protocol by describing what should be included.

Introduction

The introduction is vital in setting the need for the planned research and the context of the current evidence. It should be supported by a background to the topic with appropriate references to the literature. A thorough review of the available evidence is expected to document the need for the planned research. This should be followed by a brief description of the study and the target population. A clear explanation for the rationale of the project is also expected to describe the research question and justify the need of the study.

Methods and analysis

A suitable study design and methodology should be chosen to reflect the aims of the research. This section should explain the study design: single centre or multicentre, retrospective or prospective, controlled or uncontrolled, randomised or not, and observational or experimental. Efforts should be made to explain why that particular design has been chosen. The studied population should be clearly defined with inclusion and exclusion criteria. These criteria will define the characteristics of the population the study is proposing to investigate and therefore outline the applicability to the reader. The size of the sample should be calculated with a power calculation if possible.

The protocol should describe the screening process about how, when and where patients will be recruited in the process. In the setting of a multicentre study, each participating unit should adhere to the same recruiting model or the differences should be described in the protocol. Informed consent must be obtained prior to any individual participating in the study. The protocol should fully describe the process of gaining informed consent that should include a patient information sheet and assessment of his or her capacity.

The intervention should be described in sufficient detail to allow an external individual or group to replicate the study. The differences in any changes of routine care should be explained. The primary and secondary outcomes should be clearly defined and an explanation of their clinical relevance is recommended. Data collection methods should be described in detail as well as where the data will be kept secured. Analysis of the data should be explained with clear statistical methods. There should also be plans on how any reported adverse events and other unintended effects of trial interventions or trial conduct will be reported, collected and managed.

Ethics and dissemination

A clear explanation of the risk and benefits to the participants should be included as well as addressing any specific ethical considerations. The protocol should clearly state the approvals the research has gained and the minimum expected would be ethical and local research approvals. For multicentre studies, the protocol should also include a statement of how the protocol is in line with requirements to gain approval to conduct the study at each proposed sites.

It is essential to comment on how personal information about potential and enrolled participants will be collected, shared and maintained in order to protect confidentiality. This part of the protocol should also state who owns the data arising from the study and for how long the data will be stored. It should explain that on completion of the study, the data will be analysed and a final study report will be written. We would advise to explain if there are any plans to notify the participants of the outcome of the study, either by provision of the publication or via another form of communication.

The authorship of any publication should have transparent and fair criteria, which should be described in this section of the protocol. By doing so, it will resolve any issues arising at the publication stage.

Funding statement

It is important to explain who are the sponsors and funders of the study. It should clarify the involvement and potential influence of any party. The sponsor is defined as the institution or organisation assuming overall responsibility for the study. Identification of the study sponsor provides transparency and accountability. The protocol should explicitly outline the roles and responsibilities of any funder(s) in study design, data analysis and interpretation, manuscript writing and dissemination of results. Any competing interests of the investigators should also be stated in this section.

A study protocol is an important document that specifies the research plan for a clinical study. It should be written in detail and researchers should aim to publish their study protocols as it is encouraged by many funders. The spirit 2013 statement provides a useful checklist on what should be included in a research protocol [ 1 ]. In this paper, we have explained a straightforward approach to writing a research study protocol.

None declared.

Chan   A-W , Tetzlaff   JM , Gøtzsche   PC , Altman   DG , Mann   H , Berlin   J , et al.    SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials . BMJ   2013 ; 346 : e7586 .

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• national health service (uk)

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• A   clinical research protocol is a document that describes the background, rationale, objectives, design, enrollment criteria, methodology, data recording requirements, statistical considerations, and organization of a clinical research study.
• The protocol details exactly how the study should be conducted and therefore sets uniform standards for study conduct, allowing researchers to combine data from multiple sites to reach valid conclusions.
• Protocol review involves an assessment of the protocol to ensure that the study can be successfully completed considering the available resources and capabilities. 

Policies/guidelines

• Why is the study being done? Review the background, objectives or purpose, and study design information in order to obtain a general idea of the study and the target participants.
• How many people will be in the study, and who can participate? Review the inclusion and exclusion criteria to determine who qualifies for the study and who cannot. This information is critical to an accrual feasibility assessment.  
• What tests and procedures will be performed, and how will information be gathered? Review the schedule of procedures, which outline the number and timing of study visits, in addition to the procedures and assessments performed at each visit.
• Human Research Office protocol development guidelines

Templates/forms

• UMMC Protocol Template   - Word (intranet)
•   Protocol Review  - PDF

Write an Error-free Research Protocol As Recommended by WHO: 21 Elements You Shouldn’t Miss!

Principal Investigator: Did you draft the research protocol?

Student: Not yet. I have too many questions about it. Why is it important to write a research protocol? Is it similar to research proposal? What should I include in it? How should I structure it? Is there a specific format?

Researchers at an early stage fall short in understanding the purpose and importance of some supplementary documents, let alone how to write them. Let’s better your understanding of writing an acceptance-worthy research protocol.

Table of Contents

What Is Research Protocol?

The research protocol is a document that describes the background, rationale, objective(s), design, methodology, statistical considerations and organization of a clinical trial. It is a document that outlines the clinical research study plan. Furthermore, the research protocol should be designed to provide a satisfactory answer to the research question. The protocol in effect is the cookbook for conducting your study

Why Is Research Protocol Important?

In clinical research, the research protocol is of paramount importance. It forms the basis of a clinical investigation. It ensures the safety of the clinical trial subjects and integrity of the data collected. Serving as a binding document, the research protocol states what you are—and you are not—allowed to study as part of the trial. Furthermore, it is also considered to be the most important document in your application with your Institution’s Review Board (IRB).

It is written with the contributions and inputs from a medical expert, a statistician, pharmacokinetics expert, the clinical research coordinator, and the project manager to ensure all aspects of the study are covered in the final document.

Is Research Protocol Same As Research Proposal?

Often misinterpreted, research protocol is not similar to research proposal. Here are some significant points of difference between a research protocol and a research proposal:

What Are the Elements/Sections of a Research Protocol?

According to Good Clinical Practice guidelines laid by WHO, a research protocol should include the following:

1. General Information

• Protocol title, protocol identifying number (if any), and date.
• Name and address of the funder.
• Name(s) and contact details of the investigator(s) responsible for conducting the research, the research site(s).
• Responsibilities of each investigator.
• Name(s) and address(es) of the clinical laboratory(ies), other medical and/or technical department(s) and/or institutions involved in the research.

2. Rationale & Background Information

• The rationale and background information provides specific reasons for conducting the research in light of pertinent knowledge about the research topic.
• It is a statement that includes the problem that is the basis of the project, the cause of the research problem, and its possible solutions.
• It should be supported with a brief description of the most relevant literatures published on the research topic.

3. Study Objectives

• The study objectives mentioned in the research proposal states what the investigators hope to accomplish. The research is planned based on this section.
• The research proposal objectives should be simple, clear, specific, and stated prior to conducting the research.
• It could be divided into primary and secondary objectives based on their relativity to the research problem and its solution.

4. Study Design

• The study design justifies the scientific integrity and credibility of the research study.
• The study design should include information on the type of study, the research population or the sampling frame, participation criteria (inclusion, exclusion, and withdrawal), and the expected duration of the study.

5. Methodology

• The methodology section is the most critical section of the research protocol.
• It should include detailed information on the interventions to be made, procedures to be used, measurements to be taken, observations to be made, laboratory investigations to be done, etc.
• The methodology should be standardized and clearly defined if multiple sites are engaged in a specified protocol.

6. Safety Considerations

• The safety of participants is a top-tier priority while conducting clinical research .
• Safety aspects of the research should be scrutinized and provided in the research protocol.

7. Follow-up

• The research protocol clearly indicate of what follow up will be provided to the participating subjects.
• It must also include the duration of the follow-up.

8. Data Management and Statistical Analysis

• The research protocol should include information on how the data will be managed, including data handling and coding for computer analysis, monitoring and verification.
• It should clearly outline the statistical methods proposed to be used for the analysis of data.
• For qualitative approaches, specify in detail how the data will be analysed.

9. Quality Assurance

• The research protocol should clearly describe the quality control and quality assurance system.
• These include GCP, follow up by clinical monitors, DSMB, data management, etc.

10. Expected Outcomes of the Study

• This section indicates how the study will contribute to the advancement of current knowledge, how the results will be utilized beyond publications.
• It must mention how the study will affect health care, health systems, or health policies.

11. Dissemination of Results and Publication Policy

• The research protocol should specify not only how the results will be disseminated in the scientific media, but also to the community and/or the participants, the policy makers, etc.
• The publication policy should be clearly discussed as to who will be mentioned as contributors, who will be acknowledged, etc.

12. Duration of the Project

• The protocol should clearly mention the time likely to be taken for completion of each phase of the project.
• Furthermore a detailed timeline for each activity to be undertaken should also be provided.

13. Anticipated Problems

• The investigators may face some difficulties while conducting the clinical research. This section must include all anticipated problems in successfully completing their projects.
• Furthermore, it should also provide possible solutions to deal with these difficulties.

14. Project Management

• This section includes detailed specifications of the role and responsibility of each investigator of the team.
• Everyone involved in the research project must be mentioned here along with the specific duties they have performed in completing the research.
• The research protocol should also describe the ethical considerations relating to the study.
• It should not only be limited to providing ethics approval, but also the issues that are likely to raise ethical concerns.
• Additionally, the ethics section must also describe how the investigator(s) plan to obtain informed consent from the research participants.
• This section should include a detailed commodity-wise and service-wise breakdown of the requested funds.
• It should also include justification of utilization of each listed item.

17. Supplementary Support for the Project

• This section should include information about the received funding and other anticipated funding for the specific project.

18. Collaboration With Other Researchers or Institutions

• Every researcher or institute that has been a part of the research project must be mentioned in detail in this section of the research protocol.

19. Curriculum Vitae of All Investigators

• The CVs of the principal investigator along with all the co-investigators should be attached with the research protocol.
• Ideally, each CV should be limited to one page only, unless a full-length CV is requested.

20. Other Research Activities of Investigators

• A list of all current research projects being conducted by all investigators must be listed here.

21. References

• All relevant references should be mentioned and cited accurately in this section to avoid plagiarism.

How Do You Write a Research Protocol? (Research Protocol Example)

Main Investigator    

Number of Involved Centers (for multi-centric studies)

Indicate the reference center

Title of the Study

Protocol ID (acronym)

Keywords (up to 7 specific keywords)

Study Design

Mono-centric/multi-centric

Perspective/retrospective

Controlled/uncontrolled

Open-label/single-blinded or double-blinded

Randomized/non-randomized

n parallel branches/n overlapped branches

Experimental/observational

Endpoints (main primary and secondary endpoints to be listed)

Expected Results                                                

Analyzed Criteria

Main variables/endpoints of the primary analysis

Main variables/endpoints of the secondary analysis

Safety variables

Health Economy (if applicable)

Visits and Examinations

Therapeutic plan and goals

Visits/controls schedule (also with graphics)

Comparison to treatment products (if applicable)

Dose and dosage for the study duration (if applicable)

Formulation and power of the studied drugs (if applicable)

Method of administration of the studied drugs (if applicable)

Informed Consent

Study Population

Short description of the main inclusion, exclusion, and withdrawal criteria

Sample Size

Estimated Duration of the Study

Safety Advisory

Classification Needed

Requested Funds

Additional Features (based on study objectives)

Click Here to Download the Research Protocol Example/Template

Be prepared to conduct your clinical research by writing a detailed research protocol. It is as easy as mentioned in this article. Follow the aforementioned path and write an impactful research protocol. All the best!

Clear as template! Please, I need your help to shape me an authentic PROTOCOL RESEARCH on this theme: Using the competency-based approach to foster EFL post beginner learners’ writing ability: the case of Benin context. I’m about to start studies for a master degree. Please help! Thanks for your collaboration. God bless.

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Culture and Tourism in a Smart, Globalized, and Sustainable World pp 147–170 Cite as

Case Study Protocol for the Analysis of Sustainable Business Models

• Joaquin Sanchez-Planelles 3 &
• Marival Segarra-Oña 3  
• Conference paper
• First Online: 22 June 2021

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Part of the Springer Proceedings in Business and Economics book series (SPBE)

This paper is encompassed in the process of the development of a theory about sustainability. Our aim is to present a case study protocol for performing multiple-case studies about corporate sustainability. It has been designed according to the methodology about case study research. It includes a combination of frameworks that will help researchers to draw and understand how sustainability is integrated through the value chain of the company, and it also has a set of questions that will help to know the environmental practices that the target company deploys from a strategic point of view to the most common operations. Finally, once all the information has been retrieved, it will be possible to identify the way that value generated by sustainability practices flows through the company’s activities and the way customers perceive it.

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Acknowledgements

We acknowledge Mr. Elías Amor Montiel from the ESG Department of Consum for his help and collaboration in the interview and providing us with data.

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Universitat Politècnica de València, Valencia, Spain

Joaquin Sanchez-Planelles & Marival Segarra-Oña

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Correspondence to Joaquin Sanchez-Planelles .

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Questions about Holistic Sustainability

Checking the company’s sustainable policies against these questions will allow to identify how board members deal with the subject matter and know what kind of strategies is executing the company.

Question 1: What motivated the company to become sustainable? What is the company’s purpose?

Source of data:

CEO (Chief Executive Officer)

CSO (Chief Strategy Officer)

CSO (Chief Sustainability Officer)

Sample strategies :

Mission, vision and values statements from website.

Media press.

Question 2: How is the market dealing with sustainability? Is this company a leader, follower or laggard on the implementation of sustainable practices?

Product manager

Product manager assistant

Sales manager

Products portfolio

List the direct competitors of the company.

Identify which attributes about sustainability their products have.

Identify which attributes about sustainability those companies have.

Gather data about when sustainable practices were announced by direct competitors in order to determine which one is the leader, follower and laggard.

Question 3: Analysis of the influence of sustainability in the decision-making process. Are environmental criteria taken into account during the decision-making process? List the environmental criteria used for the decision-making process. Is the company’s statement about sustainability aligned with the decision-making process?

Identify the decision-making process established by the board members of the company.

Estimate how much environmental concerns are taken into consideration during the decision-making process.

Create a framework or diagram of the decision-making process.

Question 4: What is the process for detecting market needs focused on sustainable attributes?

CMO (Chief Marketing Officer)

Sales Manager

Identify if there is a department focused on detecting market trends.

Gather data about providers that offer services related to markets analysis, consumer studies, etc.

Question 5: Analysis of the relationship with stakeholders and the influence of sustainability in the relationship between company and stakeholders.

Determine what kind of relationships has the company with:

Capital market

Networks and associations

Policymakers

Business partners

Local stakeholders

Civil society and NGO’s

Question 6: Identify if the company’s board members establish environmental goals for the short, medium and long term.

UN Sustainable Development Goals

Materiality matrix

Questions about Sustainable Business Models:

Checking the company’s business model against these questions will allow to identify how the company creates superior value to customers improving the society and reducing the environmental impact.

Question 7: Identify which activities generate value through sustainability and determine flows of value through activities.

Draw the Porter’s value chain and complete each activity

Draw the value flows between activities from the value chain.

Question 8: Classify the sustainable business model developed by the company: circular economy, sustainable production, servitisation and sustainable consumption.

Draw the flows of inputs and outputs that take part in the business.

Create an organisational chart of the company that shows the different business lines and possible sustainable business models within the company (e.g. circular economy procedures to revalorise waste).

Whom does the business model supervise?

What customer segment does the business model target? Is it targeting external or internal customers?

Question 9: Are eco-friendly products and/or services addressed to a specific market niche or are they launched to broad customer segments?

Reports about the market sector.

News or press notes published in mass media.

Question 10: How does the company informs or communicates the sustainable practices to customers, users and other groups of interest?

Chief of Staff

Identify the channels used to deliver information: videos, seminars, conferences, online courses, short sessions, etc.

Question 11: Does the company consider the degree of sustainability of its providers or partners? If does, what are those criteria?

Purchasing manager

Identify the most key partners and providers of the company.

Examine what criteria o requirements need to be matched in order to work with the company. For instance: ISO 14001, EMAS, green certificates, eco certificates, etc.

Questions about Sustainable Operations.

Checking the company’s operations against these questions will allow to identify how business processes from the operational level might reduce the environmental impact.

Question 12: List the products and/or services which incorporate eco-innovative attributes.

Draw a chart with the products and services managed by business line.

Retrieve information about eco-innovative technologies and practices developed for the last three years.

Check the eco-innovative practices that have been integrated in the company’s products or services.

Question 13: What decision-making process or criteria is considered by the company to invest resources in the development and release of eco-innovative products / services?

R&D manager

Retrieve information about eco-innovative technologies and practices developed for the last three years and identify characteristics which are similar between each other.

Identification of the customers’ needs that try to solve the eco-innovative products / services.

Question 14: Identify the business areas that create value through sustainable activities.

Complete the business model canvas (Osterwalder & Pigneur, 2010 ).

Complete the triple-layered business model canvas (Joyce & Paquin, 2016 ).

Question 15: Are the channels to deliver products and services to your customers sustainable?

CLO (Chief Logistics Officer)

Identify the channels used to deliver products and services to customers: vehicle fleet, logistics, shops, offices, stores, etc.

Identify which eco-innovations or sustainable practices have been implemented in each channel. For instance, energy efficiency processes in cooling systems, eco-innovative trucks, etc.

Question 16: Have the company implemented any measure to reduce the environmental impact of its assets? For instance, energy efficiency measures in offices and production plants, emissions-reduction devices, etc.

Production Manager

Chief of Maintenance

Identify the strategic assets of the company. For instance, production centre, factory, stores, shops, offices, vehicle fleets, fields, etc.

Examine what environmental improvements have been implemented recently in the facilities and assets. For instance, acquisitions of eco-innovative production systems, installation of solar panels, implementation of sustainable architecture principles in the company’s buildings, etc.

Questions about Sustainable Methodologies.

These questions will show if methodologies designed for implementing sustainable practices among companies are widely used by managers and which of them are the most commonly applied.

Question 17: Identify if the company has any green certificate (e.g. ISO 14,001, EMAS, BREAM, Ecologic label, etc.) or if it is working to achieve one.

Information retrieved from website.

Question 18: Examine if the company works with any international standard to report its sustainable practices.

Some of the most common international standards for measuring the implementation of sustainable practices are:

GRI (Global Reporting Initiative)

Rainforest Alliance

Question 19: Did the company use any framework or methodology to implement sustainable practices?

Some of the most common sustainable methodologies and frameworks are:

Triple-Layered Canvas

Framework for Strategic Sustainable Development

Shareholder-value framework

Value Mapping Tool

Questions about the Evolution of the Corporate Sustainability.

This question will classify the company in the stage of the corporate sustainability evolution and will enlighten the potential practices that might be deployed in order to move forward to a sustainable business model or a new business platform.

Question 20: According to the different stages of the corporate sustainability evolution, in which stage does the company fit?

Sustainability memories of the company.

Classify the company according to the following corporate sustainability stages:

Sustainable Value Chain

Eco-innovative practices

Sustainable Business Model

New business platforms

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Sanchez-Planelles, J., Segarra-Oña, M. (2021). Case Study Protocol for the Analysis of Sustainable Business Models. In: Katsoni, V., van Zyl, C. (eds) Culture and Tourism in a Smart, Globalized, and Sustainable World. Springer Proceedings in Business and Economics. Springer, Cham. https://doi.org/10.1007/978-3-030-72469-6_10

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Alternative Quality Management Systems for Highway Construction (2015)

Chapter: appendix c: case study protocol.

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APPENDIX C: CASE STUDY PROTOCOL C.1 Overview of Case Study Background Information Delivering highway projects using alternative project delivery methods demands a shift in the traditional agency quality assurance (QA) and quality control (QC) programs to accommodate the faster pace of design and construction as well as the redistribution of responsibilities among project stakeholders. Thus, the objectives of this research are to:  Identify and understand alternative quality management systems  Develop guidelines for their use in highway construction projects Alternative project delivery in highway construction often requires the application of alternative quality management systems that emphasize contractor quality control and quality assurance. These new systems allow owners to have confidence through a verification of contractor quality system processes. They also permit state transportation agencies (STAs) to satisfy due diligence requirements for federal- aid highway projects. For example, the International Organization for Standardization (ISO) 9001 quality management system regulates quality management at all levels from material suppliers through the contractors to owners. It requires a formal project performance evaluation after completion and uses that information to publish contractor performance ratings, which can then be used for future contractor prequalification. The U. S. Army Corps of Engineers’ quality management system relies on detailed guide specifications and rigorous on-site testing by contractors. The Corps has used alternative project delivery on a routine basis for over thirty years on a wide variety of heavy civil projects that include roads and bridges, and as a result, furnishes an excellent analog from which to draw lessons learned and best practices that apply to highway design and construction. Research is needed to provide guidance on the use of alternative quality management systems for highway construction projects using alternative delivery methods. This research needs to address the major quality issues associated with these methods including accelerated project timelines and the change of the designer-of-record’s (DOR) contractual relationships with the owner to permit the required level of integration with the construction contractor. Issues of quality are further complicated by the addition of private funding of public projects in public-private partnerships (PPP). On these projects, an argument can be made that since the concessionaire is at risk for project performance the public agency has few if any reasons to involve itself in the quality management process. From current and past projects, there exists a limited but rapidly expanding body of experience associated with alternate methods of assuring quality. The purpose of this research is to bring together this relatively new body of experience and summarize it in one easily accessible reference treating the subject of QA in alternative projects. The case studies for this research will be used to learn how existing projects have managed quality in light of non-traditional delivery methods. After analyzing and comparing the various case studies, the information gathered will be condensed into working theories and used to modify what the authors of this research are calling the Integrated Quality Management Model (IQ2M) shown in Figure C1. The model was developed to be generic to all forms of project delivery and furnish a foundation for assigning quality management responsibilities between the owner, the designer, and the constructor. As such, it acts as a framework to structure the analysis of other 167

alternative project delivery quality systems that are common in highway construction and will be used in that manner in this research. Figure C1 – Integrated Quality Management Model (IQ2M) (adapted from Synthesis 376 (Gransberg and Molenaar 2008)) Relevant Definitions Across the highway construction and engineering industry, terms relating to quality often have multiple meanings that in some cases overlap with one another and in others supersede each other. To prevent confusion among several vital terms important to this study, the following definitions have been provided. These definitions are in accordance with the most recent issuance of the TRB Circular Glossary of Highway Quality Assurance Terms E-C137 and the NCHRP Synthesis 376. • Quality: (1) The degree of excellence of a product or service. (2) The degree to which a product or service satisfies the needs of a specific customer. (3) The degree to which a product or service conforms to a given requirement. • Quality Assurance (QA): All those planned and systematic actions necessary to provide confidence that a product or facility will perform satisfactorily in service. [QA addresses the overall problem of obtaining the quality of a service, product, or facility in the most efficient, economical, and satisfactory manner possible. Within this broad context, QA involves continued evaluation of the activities of planning, design, development of plans and specifications, advertising and awarding of contracts, construction, and maintenance, and the interactions of these activities.] TRB E-C074. 168

• Quality Control (QC): Also called process control. Those QA actions and considerations necessary to assess and adjust production and construction processes, so as to control the level of quality being produced in the end product. TRB E-C074. • Quality Management (QM): The overarching system of policies and procedures that govern the performance of QA and QC activities. The totality of the effort to ensure quality in design and/or construction. • Design-Bid-Build (DBB): A project delivery method where the design is completed either by in- house professional engineering staff or a design consultant before the construction contract is advertised. Also called the “traditional method.” • Design-Build (DB): A project delivery method where both the design and the construction of the project are simultaneously awarded to a single entity. • Construction Manager-General Contractor (CMGC): A project delivery method where the contractor is selected during the design process and makes input to the design via constructability, cost engineering, and value analysis reviews. Once the design is complete, the same entity builds the projects as the general contractor. CMGC assumes that the contractor will self-perform a significant amount of the construction work. • Construction Manager-at-Risk (CMR): A project delivery method similar to CMGC, but where the CM does not self-perform any of the construction work. • Public Private Partnership (P3): A project delivery method where the agency contracts with a concessionaire organization to design, build, finance and operate an infrastructure facility for a defined extended period of time. • Design deliverable: A product produced by the design-builder’s design team that is submitted for review to the agency (i.e. design packages, construction documents, etc.). • Construction deliverable: A product produced by the design-builder’s construction team that is submitted for review to the agency (shop drawings, product submittals, etc.). Statement of Purpose The primary research objectives and research questions for this project are as follows: Objectives • Document and categorize current practices and applications of Quality Management Systems (both traditional and alternative) in highway construction for all project delivery methods • Explore how highway construction projects of all project delivery methods are effectively applying alternate quality management systems. (developing and implementing quality management systems) • Identify benefits and limitations of the approaches 169

• Explore how to implement and apply quality management system for all methods of project delivery • Produce a guidebook that will match appropriate quality management systems to selected alternative delivery methods o Describes the quality systems in the I2QM model o Discusses the barriers to each system o Gives guidance for individual roles in development and adoption of alt. quality management models in their agency • Produce a research report that addresses the implications of adopting the guidelines and the barriers to implementation Research Questions 1. What is the fundamental definition of quality and what is the underlying purpose of a “quality program?” 2. How are projects using alternative delivery methods currently applying quality management systems? 3. What are the advantages and disadvantages to the contractor and the owner of alternative quality management systems relating to various project delivery alternatives? 4. What changes must be made to the baseline quality management system to adapt to evolving project delivery methods? Relevant Readings The protocol is based largely on the following documents and research reports.  NCHRP Project 10-83 Proposal  Coding Structure for NCHRP Project 10-83  TRB Circular E-C137 Glossary of Highway Quality Assurance Terms  NCHRP Synthesis 376  NCHRP Synthesis 40-02 170

C.2 Field Procedures Project Researchers The following is a list of the project investigators and their contact information.  Keith R. Molenaar, Ph.D. – Principal Investigator K. Stanton Lewis Chair and Associate Professor Construction Engineering and Management Program Department of Civil, Environmental, and Architectural Engineering University of Colorado at Boulder Campus Box 428, ECOT 643 Boulder, Colorado 80309-0428 Telephone: 303-735-4276 Facsimile: 303-492-7317 E-mail: [email protected]  Douglas D. Gransberg, Ph.D., P.E. – Co-Principal Investigator Donald and Sharon Greenwood Chair and Professor of Construction Engineering Construction Engineering and Management Program Department of Civil, Construction, & Environmental Engineering Iowa State University 456 Town Engineering Ames, IA 50011 Telephone: 515-294-4148 E-mail: [email protected]  David N. Sillars, Ph.D. – Co-Principal Investigator R.C Wilson Chair and Associate Professor Construction Engineering and Management Program Civil and Construction Engineering Oregon State University 220 Owen Hall Corvallis, Oregon 97331 Telephone: 541 737-8058 Fax: 541 737-3300 Email: [email protected]  Elizabeth R. Kraft Graduate Student Construction Engineering and Management Program Department of Civil, Environmental, and Architectural Engineering University of Colorado at Boulder Campus Box 428 Boulder, Colorado 80309-0428 171

Telephone: Facsimile: Email: [email protected]  Nickie West Graduate Student Construction Engineering and Management Program Department of Civil, Construction, & Environmental Engineering Iowa State University 456 Town Engineering Ames, IA 50011 Telephone: Facsimile: E-mail: [email protected]  Landon S. Harman Graduate Student Construction Engineering and Management Program Civil and Construction Engineering Oregon State University 220 Owen Hall Corvallis, Oregon 97331 Telephone: Email: [email protected] Case Study delegation Note: The information in this section will not be available until after potential case studies have been identified and selected for study. When this information is available, this section will list who will be contacting each case study, what the scope of their questions/role will be, and who will be following up to garner additional information or thank participants for their time and effort. Case Study Identification and Schedule Case study project selection criteria In the original research proposal, it was stated that “a concerted effort will be made to select case study projects from transportation agencies that have mature experience with at least two different project delivery methods.” A total of 6 – 12 case studies will be performed with at least two of the case studies coming from a non-STA (USACE or the FTA). Additionally 2 pilot studies will be conducted and reviewed prior to the remaining studies to validate the case study protocol and data coding and to ensure that the research objectives will be met by the data collected. Potential case studies will be identified in Task 1 of the research as a part of the initial survey that aims to identify alternative quality management systems currently in use. The results of this survey will be used to populate an initial list of potential case studies. Case study project selection protocol will involve three tiers of project information that must be present to move a potential case study project into the 172

final list of candidates. The case study candidates will be forwarded to the NCHRP Panel for approval. The tiers are as follows: 1. Project Factor Information: This tier seeks to create a uniform set of data points for every case study project to ensure that trends or disconnects found during analysis can be uniformly mapped across the entire case study population (Yin 2008). Examples of this information are project location, size, major type of construction, initial and final budget amounts, initial and final delivery periods, delivery method, and other factors as required. 2. Project Quality Factor Information: This tier seeks to explicitly define the precise details of the system used to manage quality across the case study project’s life cycle. Examples of this information are quality plans, quality organization composition, use of consultants for independent technical review or independent assurance/oversight, quality audits, division of quality management responsibility between the various stakeholder in the project and other factors as required. 3. Project Performance Information: This tier seeks to measure, if possible, the success of the quality management system employed in each project. It will use to the extent possible the stipulated performance metrics for scope, schedule, cost, quality and risk that were created for each case study project and will attempt to back-calculate performance metrics for common areas in all the projects to furnish a means of comparison and to identify and quantify the magnitude of the trends and disconnects in the case study project population. In addition to the above, a concerted effort will be made to select case study projects from transportation agencies that have mature experience with at least two different project delivery methods. The FHWA Report to Congress on Design-Build Effectiveness (2006) identified more than 30 state STAs that had been authorized to delivery design-build projects under SEP-14 authority. However, of that sample 12 had not completed a single design-build project, another eight had only completed one design-build project, and only six had finished more than five design-build projects. Thus, at that point in time, for this project delivery method the quality management systems of only six STAs could have been impacted by multiple project experiences. Since that time additional experience has been gained and NCHRP Synthesis 376 (2008) reported that four STAs had completed five to 10 design-build projects and nine had completed greater than 10. Thus, depending on the final criterion for design-build experience, as many as 13 STAs will have potential case study design-build projects that had quality management systems that were tailored for DB project delivery. That is not the case in construction management at risk. NCHRP Synthesis 40-02 (2010) reported that only Florida and Utah have completed more than a single construction management at risk project. Thus, case study projects with construction management at risk tailored quality management systems will have to come from those two STAs or from another mode of transportation such as transit. To summarize, the primary criterion for case study project selection will be the requirement to have come from an agency that has sufficient experience with a given project delivery method that the potential exists that the project was designed and built using a quality management system that was modified from the baseline design-bid-build system based on actual experience, using the USACE cyclical quality management system where quality management experience is fed back into the quality planning process to continuously improve the performance of the system itself. 173

This list of potential case studies created from the previously mentioned protocol will be supplemented by the Industry Advisory Board and the investigators’ industry contacts. The following three pieces of information will have been collected for each case study as a part of the survey in Task 1: (1) name and location of the project; (2) description of the project delivery, procurement, and contracting method in use; and (3) description of the quality management system. The goal for selecting the case studies will be to generate a cross section of cases that allow for analysis of the advantages and disadvantages of the quality management systems across the various project delivery method characteristics. To ensure that this goal is met, the following criteria will be placed on the case study selection will include: • Quality management systems for design and construction; • Quality assurance by all parties and independent auditors; • Project quality assurance including independent verification and independent acceptance; • Project delivery methods including design-build, construction manager-at-risk, and PPP; • Procurement methods including best value, A+B, and qualifications-based selection; and • Payment methods including incentives, lump sum, and guaranteed maximum price. Case study informant selection Once a case study project has been selected, several members of the team directly associated with creating and implementing the quality management plan will need to be interviewed. While many people are responsible for ensuring quality on a project during its lifecycle from conception through construction, we will seek to speak with – at a minimum – enough project team members to fully satisfy the research objectives and goals. This may include speaking with representatives from the owner’s, designer’s, and contractor’s project team to develop a full picture of the quality management systems utilized on a project and their relation to each other. Potential interviewees include the following:  Agency project manager, contracting manager, quality manager, etc.  Project design manager, construction manager, design quality manager, construction quality manager, etc.  Designer quality manager, project manager  Contractor preconstruction manager, quality manager, project manager  Third party quality assurance/quality control inspectors 174

Case Study Basic Data and Research Delegation Tables # Case Study Name Location Organization Contact (Information) 1 2 3 4 5 6 7 8 # Case Study Name Contacted? Lead Investigato r Interview Type Intervie w Date Follow-up Date 1 2 3 4 5 6 7 8 175

# Case Study Name Materials/Documents Received 1 2 3 4 5 6 7 8 C.3 Requested Documents The following is a list of documents that will be requested. However, successful completion of the research study does not require that each of the documents is collected. A subset of these documents will likely be collected depending upon the unique attributes of the project being studied. • Project RFP/RFQ • Project RFP/RFQ Response • Project Quality Management Plan • Project Design Quality Plan • Project Construction Quality Plan • Agency/Company Quality Plan • Project Quality Organizational Chart • Copy of the contract with the engineer/contractor/consultant • Organizational document that outlines its approach to quality assurance on project Case Study Questions This section seeks to formalize the interview questions asked of each case study to allow for easier comparison and analysis between case studies later on. Each interview will be unique and largely guided by the case study participants. To draw out the pertinent information, specific questions may be needed while some of the questions listed here may not be relevant. In modifying the protocol questions, generality should still be maintained so that the results can still be readily compared and categorized according to the coding structure. 176

Questionnaire The purpose of the questionnaire is to identify how state highway agencies (SHA) have implemented alternative QA programs and from that baseline, identify commonly used practices for dissemination and use by SHAs that intend to implement alternative procurement on future projects or alternative QA methods in their current program. The questionnaire consists of closed ended questions which will allow the researchers to perform a quantitative analysis. The data gathered by the questionnaire will be used to validate the case study findings. Ideally this questionnaire will be completed by the respondent prior to the interview. If it is not completed prior to the interview then it will be requested that the respondent complete it during the interview. The questionnaire is included in APPENDIX B. Background and Overall Quality Questions Background  Background information to keep track of who we spoke with on each project  Relevant prior experience used to potentially weight their opinions in later comparison 1. Name, occupation, employer 2. What are you current duties, especially related to QM, QA, QC? 3. Have you held any positions prior to your current position related to QM, QA, or QC? If so, please briefly list that information. 4. How long have you held your current position? 5. Have you worked on projects of different project delivery methods? If so specifically what project delivery methods do you have experience with? 6. How many years of experience do you with projects using baseline/DBB quality systems? 7. Name and location of the project for which you are answering project-specific questions Overall Understanding of Quality  Examines the overall understanding of quality and the informants attitudes towards quality  Establishes a baseline of traditional/DBB quality for comparison 8. How do you define project quality? 9. What is your understanding of the differences between quality management, quality assurance, and quality control? 10. In your experience, how has quality management been approached on a traditional/DBB project?  Project by project basis?  During the RFP process?  Dictated by owner agency? If so, how is it dictated?? Specifications, performance… 11. What are the critical elements/milestones of a quality management plan on a traditional/DBB project? 12. How are the quality roles and responsibilities divided on a traditional/DBB project? 13. In your experience, what quality systems/procedures have been successful on traditional/DBB projects? 177

14. What are some characteristics of a successful quality management plan, regardless of the project delivery method, contracting method, or procurement method? Organizational Questions  Provides the needed categories and statistics (from the coding structure) to later sort and group the enterprise level QM information we receive. As not everyone selected for an interview will have answered the survey, these questions are not redundant Please answer the following questions related to quality management at different phases of a project for the organization you work for as a whole. Please be as thorough as possible when discussing what quality management systems may exist and be utilized within your organization. 15. Of the projects your organization designs/builds/owns what percent of the projects are managed using the following delivery methods:  Design-bid-build (DBB): ______  Design-build (DB): _______  Construction Manager/General Contractor (CM/GC): _______  Public-Private-Partnership (PPP): _______  Other (please list): _______ 16. Of the projects your organization designs/builds/owns what percent of the projects are procured using the following procurement methods:  Cost: ______  Best-value: _______  Qualifications: _______  Design: _________ 17. Of the projects your organization designs/builds/owns what percent of the projects utilize the following contract payment methods:  Payment type: ________  Incentive type: ________ 18. If you work for a STA, what due diligence requirements must your organization meet in your state for quality assurance purposes on public projects?  Please list applicable laws, reporting requirements, or processes required in your state  Can you utilize new or alternative quality management practices that produce equal or superior quality projects to meet these requirements? If not, what legal barriers prevent you from doing so?  If so, what steps are required to do this? Has this been done before? Please describe if it has. 19. Does your organization perform any in-house design work?  On what percent of your projects do you perform in-house design?  Do you have formal quality assurance systems in place for this process?  If so, please describe this process. 20. Does your organization self-perform any construction work?  On what percent of your projects do you self-perform some amount of construction?  Do you have formal quality assurance systems in place for this process?  If so, what are they? 178

Design Phase QM  Examines design QM and is broken up into components according to the coding structure to allow for easier comparison between case studies later on  How is design quality management managed on all project delivery types whether design is kept in-house or out of house 21. Does your organization have any design quality assurance systems in place?  If so, please describe the systems, policies, procedures, techniques, or standards used to ensure the quality of the designs you produce or receive. Can you provide us with an electronic or hard copy of these systems, policies, procedures, techniques, or standards?  Have you found these systems to be effective at producing quality designs? If yes, what makes them superior to other systems you are familiar with or function well? If no, what changes would you suggest to increase their efficacy?  Are there any additional procedures that would further improve the quality of designs you produce or receive? If so, please describe them. 22. Does your organization have any design quality control systems in place?  If so, please describe the systems, policies, procedures, techniques, or standards used for quality control of the designs you produce or receive. Can you provide us with an electronic or hard copy of these systems, policies, procedures, techniques, or standards? 23. Does your organization utilize any form of peer review or 3rd party/independent design quality assurance?  If so, please describe how this is conducted and how the results are utilized to improve the quality of the original design.  If this process is formalized, can you provide us with any documents detailing it? Construction Phase QM  Examines construction QM from a STA’s point of view and is broken up into components according to the coding structure to allow for easier comparison between case studies later on  The primary focus of many QM plans and where the bulk of the information gathered at an enterprise level may be found 24. How does your organization perform construction quality assurance? Who has primary responsibility?  Does the process change based on the project type, contract style, or delivery method? If so, how is the process tailored? Who decides which method will be used?  Has your organization experimented with new quality assurance methods? Are you actively implementing any now? If so, what are they and how have you evaluated their efficacy?  Has your organization modified traditional quality assurance processes to make them applicable to projects with alternative delivery methods? If so, how have you modified them? 25. Who is responsible for construction quality control on projects your organization is a part of?  What is the process used for quality control? If this process changes due to project type, contract style, or delivery method, how does it change?  Do you still utilize traditional quality control methods such as control charts?  Has your organization modified traditional quality control processes to make them applicable to projects with alternative delivery methods? If so, how have you modified them? 179

 Has your organization experimented with new quality control methods? Are you actively implementing any now? If so, what are they and how have you evaluated their efficacy? 26. What role does independent assurance (IA) play in your projects?  Which parties – owner, designer, or builder – utilize IA to ensure a quality product? 27. How is owner verification testing used in your traditional projects?  What role does it have in your projects?  What statistical tests are used to verify the contractor’s results?  Who conducts the testing the owner or a third party?  Is it used on your non-traditional projects as well? If so, what function does it serve on those projects? 28. How is owner acceptance testing utilized on this project?  Is this seen as sufficient justification of quality construction to ensure final payment? How are the results used?  Who conducts the testing, the owner or a third party?  If it is used on non-traditional projects, what function does it serve? 29. Does your organization make use of or offer any form of post-construction quality assurance? Please describe this if you can.  Is this part of a warranty or of an operate-and-maintain contract? If not, what is it?  If you are engaged in contracts with warranties or operate-and-maintain clauses, how does this impact your quality management model before and during construction? Project Specific Questions Please answer the following questions for the specific project you were contacted about. While not every question may apply to your project, please be as thorough as possible. If you have additional information regarding the quality management process on you project that you would like to provide, please feel free to add that below or contact us directly. Procurement and delivery method  Used to categorize the case studies for later comparison, these identifying questions will help focus future analysis  Seeks to explore the relationship (if one exists) between the delivery method selected and the QM techniques used 30. What delivery method is being/was used for this project (DBB, DB, CM/GC, PPP, etc.)? 31. What procurement method (cost, best-value, qualifications based, design based, A + B, multiparameter bidding, etc.) was used to select the designer/builder/concessionaire on this project? 32. Was a prequalification process used? If so, please describe that process.  If a prequalification process was used, were interested parties required to submit a quality management plan (QMP)? Were they required to identify a dedicated quality manager? If you still have the QMPs from the initial solicitations, can you provide us with copies? 33. What requirements related to Quality were included in the RFP? 180

 Submittal of a QMP prior to award, qualifications of the quality staff on the project, submittal of a QMP after award, etc. 34. Were either the procurement or delivery methods selected partially or in whole because of their effect on quality management? If so, why were the particular methods selected? 35. What contract payment approach was selected for the project, payment or incentive?  What effect did this have/is this having on quality management on the project? Quality Management Plan  Determine roles and responsibilities for creating the overall quality management plan  Determine the purpose/requirements of the quality management plan  Determine how the Quality Management plan was developed and approved 36. How was the Quality Management Plan (QMP) created?  Was it a stock plan modified for the project? Was it created from scratch? 37. Who was responsible for creating the Quality Management Plan? 38. How was the overall quality management hierarchy created for this project?  What is the overall quality management hierarchy? Can you provide us with a copy of the org chart? 39. What were the Agency’s quality objectives/requirements for this project and how were these communicated? 40. Describe the QMP approval process. 41. How did the QMP differ from a traditional DBB project QMP?  Why did this project’s QMP need to be different from a traditional DBB? 42. How was the QMP development process different from a traditional DBB project?  Why was this projects QMP development process different from a traditional DBB QMP development? 43. How was this QMP and its development process successful?  What about the QMP and its development process could be improved for the next project? 44. What other management plans were required for this project and what were the quality roles and responsibilities associated?  Design, construction, environmental, traffic, etc… 45. Describe how the quality management on this project is different from a traditional DBB project  What procedures/processes/systems were different?  What project factors required the design quality management plan to be different from the traditional (project delivery, project complexity, funding), Design phase QM  Details the specific design QM techniques used on this project as broken down by the coding structure and gathers any additional information related to this process 181

 Seeks to understand the relationship between the techniques used on the project and those recommended at the agency-wide level  Seeks to understand how the design QM was developed and approved and requests the needed documents 46. How was the design Quality Management Plan (QMP) created and by whom?  What requirements was it based on? 47. What was your organization’s role/responsibilities in developing and implementing the design QMP on this project? 48. What was the project hierarchy (org chart) for this phase of the project? Who was responsible for design QA/QC on this project?  Can we get a copy of that chart? 49. What was the approval process for the Design QM? 50. How were the Agency’s design quality requirements communicated to the Designer?  By RFP, design guidelines, performance specifications, etc. 51. Describe how the design quality management on this project is different from a traditional DBB project  What procedures/processes/systems were different?  What project factors required the design quality management plan to be different from the traditional (project delivery, project complexity, funding), 52. What was the basic premise of the design QMP for this project?  Over the shoulder reviews, spot checks, design checks at certain milestones, etc. 53. Was quality assurance incorporated in the design phase of this project? If so, how was it implemented on this project?  Who was responsible for QA, the owner or designer?  Was a formal plan drafted detailing how design QA would be considered? If so, can you provide us with a copy of that report? 54. Were design quality control processes utilized on this project? If so, how?  Are there documents outlining these processes? If so, can you provide us with a copy? 55. Was a dedicated design quality manager assigned by the owner, designer, CM, or concessionaire? What were their responsibilities? What authority did they have to make changes to the design or QA processes? 56. Was a peer review or independent assurance component included in design phase quality management?  If so, what was its role and how did it impact the final design? 57. What problems were discovered and corrected through the design phase quality management process?  What problems were not discovered until the construction phase of the project? Could these have been avoided with a more robust design quality management process? If so, what changes would need to be made to your process to catch these problems in the future? 182

58. Was the design phase QMP used on this project a standardized system used on most or all of your organization’s projects? If not, was it tailored to meet the needs of this project from an existing process or created from scratch for this project?  How much time/what resources did creating the design QMP for this project require?  If an existing design QMP was modified for this project, can you provide copies of both for comparison? 59. How effective was the design QMP on this project?  How could it have been improved? Construction Phase QM  Details the specific construction QM techniques used on this project as broken down by the coding structure and gathers any additional information related to this process  Seeks to understand the relationship between the techniques used on the project and those recommended at the agency-wide level  Seeks to understand how the design QM was developed and approved and requests the needed documents 60. How was the Construction Quality Management Plan (QMP) created and by whom? 61. How much of the quality systems were developed during the RFP/contracting phase?  Was a quality plan required at RFP submittal? after award?  Was the quality plan developed collaboratively? 62. What was the approval process for the construction QMP? 63. How were the Agency’s design quality requirements communicated to those crafting the construction QMP?  By RFP, design guidelines, performance specifications, etc. 64. How were this project’s QM, QA, and QC systems different from a project using traditional DBB?  Roles/responsibilities, liabilities, etc.  What project factors required the design quality management plan to be different from the traditional (project delivery, project complexity, funding), 65. Was there a dedicated quality manager for this project? Who employed the manager, the owner, builder, designer, concessionaire, etc.?  What responsibility and authority to make changes did this manager have? 66. How was construction quality assurance put into place on this project? 67. What role did construction quality control play on this project? If a problem was discovered in the QC process, were changes made quickly enough to prevent future problems?  What facilitated or hindered this rapid communication?  How was QC implemented on this project? 68. Was owner verification testing used on this project to check the contractor’s QC process?  Who performed the testing, the owner or a 3rd party?  Were significant discrepancies discovered on this project? If so, did the QMP provide an effective way to deal with these? How? 69. Was owner acceptance testing included on this project before final payment? 183

 Who performed this testing?  Were significant issues discovered?  How were they handled? Were all parties satisfied with the outcome? 70. Was independent assurance included as part of the construction QMP on this project?  If so, what role did it play in quality management on the project? 71. What other features/systems were parts of the QMP during the construction phase of this project?  What additional features could have prevented quality issues from arising on this project? 72. How was QM in the construction phase affected by the contract delivery method?  By the procurement method? 73. Can you provide a copy of the construction QMP for this project?  Did you modify an existing QMP for the construction phase of this project or develop one from scratch? If you modified an existing plan, can you provide copies of both for comparison? 74. What challenges did the QMP on this project face and how were they overcome? 75. Overall, were you satisfied with the quality management of the construction phase of this project?  Which particular aspects of the QMP were you especially pleased with?  If not, what would you change regarding quality management for your next project? 76. Based on your experience, would any of the quality techniques/systems used on this project be beneficial if applied to a traditional/DBB project? Post-Construction QM  Explores whether a formal policy for QM relating to the post-construction period exists and if such a policy exists, seeks to understand its relationship to the QMP implemented during design and construction of the project 77. Did/does this project include any warranty or operate-and-maintain provisions in the contract? If no, skip the rest of this section. If yes, please answer the following questions.  How did the inclusion of these provisions affect the QMP during construction?  When compared with other projects NOT having these provisions, how did these provisions affect the overall quality of the project? Additional Questions  This section is designed to allow for further refinement of the interview (in the pilot study phase)  Offers the participant the opportunity to add any additional information he/she believes is relevant to our study that we may have overlooked or not asked about for lack of project specific knowledge 78. As a case study participant, how easy to understand did you find the interview questions? Were they straight forward? Did you struggle to understand the intent of some questions? In addition to any answers to these questions, please provide a rating from 1 to 10 (10=easy to understand, 1=so hard to understand it was difficult to finish). 184

 Which questions did you find especially difficult to understand or answer? 79. Did the interview seem repetitive to you? If so, what sections/questions seemed to contain overlapping material? 80. Was the interview burdensome to complete? Were you able to answer each question to the extent of your knowledge without fatigue? 81. Given our project objectives, what additional information can you provide that would help us to better understand alternative quality management? What other QM processes, procedures, or ideas are you aware of (for any phase of a project) that you have not shared with us thus far or have been unable to utilize first-hand? 82. Given our project objectives, are there additional questions that you feel we should be asking? If so, what questions would you suggest? 83. Do you know of any other co-workers or industry peers with a position related to quality management that would be interested in speaking with us? If so, can you provide their contact information? 84. Are you aware of any projects that have utilized or are utilizing excellent quality management procedures on a project with a non-traditional delivery method (DB, CM/GC, PPP, etc.)? If so, can you provide us with the name, location, and any other pertinent information for the project? C.4 Data Analysis • The complete data analysis plan is described in the project Work Plan. The main points of the analysis include: • Advantages and disadvantages to each system from the agency’s and the designer’s/constructor’s point of view; • Identification of trends and common finding between the lit review, survey and case studies; • Triangulate the common findings from these three sources of data to arrive at valid conclusions; • Case studies will be summarized individually in the lens of the IQ2M model; • Using literature review and survey information, compare key attributes of the baseline approach to key attributes in the IQ2M models. (design quality is a gap, but rigorous comparison of construction quality control, construction quality assurance and independent audit procedures will be made); • Individual findings will analyzed across the cases using pattern matching techniques; and • Comparison to baseline quality management system approaches. 185

C.5 Case Study Contact Flowchart #1 Phone •Call contacts for identified case studies and secure their agreement to act as a champion for the case study process • Set up a date and time for the case study interview during this contact #2 Letter • Send letter #1 from the case study protocol to the contact confirming their agreement to act as a champion •This letter should include a brief outline of our project goals and documents we will request #3 Letter • Send letter #2 from the protocol and the questionnaire to participant and ask them to fill it out before the interview if possible •This letter should also include a list of the documents we will be requesting, ask them to collect them ahead of time if possible #4 In-Person •Conduct the case study interview at the agreed time and date •Before leaving the interview, be sure that at a minimum: the questionnaire has been filled out and the needed documents have been collected #5 Letter • Send letter #3 from the protocol thanking the participant for their time and assistance and offer to share the results of the research with them when it is finished 186

C.6 Sample Letters Letter #1 MEMORANDUM DATE TO: Survey Participant FROM: Keith Molenaar Principal Investigator SUBJECT: NCHRP 10-83 Case Study Thank you for agreeing to participate in the NCHRP 10-83 Research Project case study concerning alternative quality management procedures for highway construction projects utilizing non-traditional contracts. We have enclosed some brief background information about the research project, its objectives, goals, and methods. We are currently scheduled to (meet with/call) you on (insert day/month) at (insert time) to conduct our interview. If for some reason this no longer works for you, please contact me as soon as possible to reschedule. Before our interview, we will send you a questionnaire related to the topics we would like to cover in the interview. Please review the questionnaire prior to the interview to become acquainted with the nature of the questions that we will be discussing. I’ve attached a brief outline of our research interests along with a list of documents related to the project that we would like to collect. If you have any questions, please feel free to contact me by telephone at 303-735-4276 or by email at [email protected]. Regards, Keith Molenaar Requested Documents Below is a list of documents we would like to collect regarding the project this case study is focusing on. While your project may not have all of the listed documents, we need to obtain a copy of any of the documents included on your project as well as any additional documents not listed that you believe are relevant to our research objectives as outlined below. While we would prefer (hard/electronic) copies, 187

either will suffice. Additionally, are there any online resources we can examine (FTP sites, project websites, etc.) before the interview to familiarize ourselves with the project? • Copy of the contract with the engineer/ contractor/ consultant • Organizational document that outlines its approach to quality assurance on project • Project RFP/RFQ • Project Quality Organizational Chart • Project RFP/RFQ response • Project Construction quality plan • Project Quality Management Plan • Agency/Company quality plan • Project design quality Plan • Project Background The NCHRP 10-83 research project has four primary research objectives. They are to: • Document and categorize current practices and applications of Quality Management Systems (both traditional and alternative) in highway construction for all project delivery methods • Explore how highway construction projects of all project delivery methods are effectively applying alternate quality management systems. (developing and implementing quality management systems) • Identify benefits and limitations of the approaches • Explore how to implement and apply quality management system for all methods of project delivery In the course of meeting those objectives, we will seek to answer these four questions: 1. What is the fundamental definition of quality and what is the underlying purpose of a “quality program?” 2. How are projects using alternative delivery methods currently applying quality management systems? 3. What are the advantages and disadvantages to the contractor and the owner of alternative quality management systems relating to various project delivery alternatives? 4. What changes must be made to the baseline quality management system to adapt to evolving project delivery methods? To answer these questions, we are performing several in-depth project case studies, covering both traditional and alternative delivery methods. The case studies will be used to learn how existing projects have managed quality in light of non-traditional delivery methods. After analyzing and comparing the various case studies, the information gathered will be condensed into working theories, used to modify what we are calling the Integrated Quality Management Model (IQ2M), and ultimately used to prepare a final research report for the NCHRP and a set of guidelines for when implementing certain AQM systems may be useful in light of other project characteristics. 188

Letter #2 MEMORANDUM April 17, 2015 TO: Survey Participant FROM: Keith Molenaar Principal Investigator SUBJECT: NCHRP 10-83 Case Study Questionnaire Thank you again for your assistance with this research effort investigating alternative quality management procedures for highway construction projects utilizing non-traditional contracts. Enclosed is a questionnaire that touches on many of the topics we would like to cover in our in-depth interview. The questionnaire will be used as a baseline to generate easily comparable data across all of the different case studies we will be performing. It will be a starting point for our discussion and we would greatly appreciate it if you would take the time to look it over and fill it out to the best of your ability before our scheduled interview on (insert day/month) at (insert time). Also enclosed is a list of the documentation we are seeking for this case-study. While we would prefer (hard/electronic) copies, either will suffice. If this information is available on a website for FTP site, please let us know so that we may familiarize ourselves with the information ahead of time. If you have any questions, please feel free to contact me by telephone at 303-735-4276 or by email at [email protected]. Regards, Keith Molenaar 189

Letter #3 MEMORANDUM April 17, 2015 TO: Survey Participant FROM: Keith Molenaar Principal Investigator SUBJECT: NCHRP 10-83 Case Study Follow-Up Thank you for your participation in the NCHRP 10-83 interview process. We recognize that this process is time consuming and very much appreciate your assistance in helping us better understand alternative quality systems in this industry. Your insight and experience with this project will be invaluable as we compare it with projects from across the country and try to develop a better understanding of which systems work well and which do not. The research report and guidelines will not be finished until the summer of 2012, but we would be happy to share the research results with you then if you would like. Again, thank you for your time! If you have any questions, please feel free to contact me by telephone at 303-735-4276 or by email at [email protected]. Regards, Keith Molenaar 190

C.7 Questionnaire INTRODUCTION/BACKGROUND: The purpose of this questionnaire is to identify how state highway agencies (SHA) have implemented alternative QA programs and from that baseline, identify commonly used practices for dissemination and use by SHAs that intend to implement alternative procurement on future projects or alternative QA methods in their current program. DEFINITIONS: The research will use TRB Circular E-C074, Glossary of Highway Quality Assurance Terms to standardize its terminology. The following are terms that must be carefully understood to properly complete this survey. Quality: (1) The degree of excellence of a product or service. (2) The degree to which a product or service satisfies the needs of a specific customer. (3) The degree to which a product or service conforms with a given requirement. Quality Assurance (QA): All those planned and systematic actions necessary to provide confidence that a product or facility will perform satisfactorily in service. [QA addresses the overall problem of obtaining the quality of a service, product, or facility in the most efficient, economical, and satisfactory manner possible. Within this broad context, QA involves continued evaluation of the activities of planning, design, development of plans and specifications, advertising and awarding of contracts, construction, and maintenance, and the interactions of these activities.] TRB E-C074. Quality Control (QC): Also called process control. Those QA actions and considerations necessary to assess and adjust production and construction processes, so as to control the level of quality being produced in the end product. TRB E-C074. Quality Management (QM): The overarching system of policies and procedures that govern the performance of QA and QC activities. The totality of the effort to ensure quality in design and/or construction. Design-Bid-Build (DBB): A project delivery method where the design is completed either by in-house professional engineering staff or a design consultant before the construction contract is advertised. Also called the “traditional method.” Design-Build (DB): A project delivery method where both the design and the construction of the project are simultaneously awarded to a single entity. Construction Manager-General Contractor (CMGC): A project delivery method where the contractor is selected during the design process and makes input to the design via constructability, cost engineering, and value analysis reviews. Once the design is complete, the same entity builds the projects as the general contractor. CMGC assumes that the contractor will self-perform a significant amount of the construction work. Construction Manager-at-Risk (CMR): A project delivery method similar to CMGC, but where the CM does not self-perform any of the construction work. Public Private Partnership (P3): A project delivery method where the agency contracts with a concessionaire organization to design, build, finance and operate an infrastructure facility for a defined extended period of time. 191

Design deliverable: A product produced by the design-builder’s design team that is submitted for review to the agency (i.e. design packages, construction documents, etc.). Construction deliverable: A product produced by the design-builder’s construction team that is submitted for review to the agency (shop drawings, product submittals, etc.). Requested Documents Below is a list of documents we would like to collect regarding the project this case study is focusing on. While your project may not have all of the listed documents, we need to obtain a copy of any of the documents included on your project as well as any additional documents not listed that you believe are relevant to our research objectives as outlined below. While we would prefer electronic copies if available, but either will suffice. • Copy of the contract with the engineer/ contractor/ consultant • Organizational document that outlines its approach to quality assurance on project • Project RFP/RFQ • Project Quality Organizational Chart • Project RFP/RFQ response • Project Construction quality plan • Project Quality Management Plan • Agency/Company quality plan • Project design quality Plan • Additionally, are there any online resources we can examine (FTP sites, project websites, etc.) before the interview to familiarize ourselves with the project? General Information -STA: 7. US state in which the respondent is employed: 8. Name of Agency: 9. Names and groups/sections of interviewees: 10. Please check the appropriate boxes for your agency’s project delivery program (PDM). Project Delivery Method Legislative/Legal Authority Number of years of experience with PDM DBB ☐NA; ☐Pilot projects only; ☐General authorization ☐NA; ☐1-5; ☐5-10;☐ > 10 CMGC ☐NA; ☐Pilot projects only; ☐General authorization ☐NA; ☐1-5; ☐5-10;☐ > 10 DB ☐NA; ☐Pilot projects only; ☐General authorization ☐NA; ☐1-5; ☐5-10;☐ > 10 P3 ☐NA; ☐Pilot projects only; ☐General authorization ☐NA; ☐1-5; ☐5-10;☐ > 10 Other ☐NA; ☐Pilot projects only; ☐General authorization ☐NA; ☐1-5; ☐5-10;☐ > 10 11. Are your Quality Management systems different between Project Delivery Methods? ☐Yes ☐No 192

12. What is the approximate proportion of in-house design versus outsourced design services? In-house design services - Click here to enter text.% Outsourced design services - Click here to enter text. % Administrative prequalification: A set of procedures and accompanying forms/documentation that must be followed by a designer or construction contractor to qualify to submit bids on construction projects using traditional project delivery. Performance based prequalification: A set of procedures and back-up documents that must be followed by a designer or construction contractor to qualify to submit a bid on a construction project based on quality, past performance, safety, specialized technical capability, project-specific work experience, key personnel, and other factors. 3. Does your agency use a prequalification program for design firms? ☐Yes ☐No If the answer to the previous question is YES, please answer for your agency’s program to prequalify design firms. Designer prequalification program factors Prequalification Type Administrative Performance Based Prequalification required for all projects ☐ ☐ Prequalification required for selected projects only ☐ ☐ Prequalification standards are the same for all projects ☐ ☐ Prequalification standards are different by project class ☐ ☐ 4. Does your agency use a prequalification program for construction contractors? ☐Yes ☐No If the answer to the previous question is YES, please answer for your agency’s construction contractor prequalification program. Construction prequalification program factors Prequalification Type Administrative Performance Based Prequalification required for all projects ☐ ☐ Prequalification required for selected projects only ☐ ☐ Prequalification standards are the same for all projects ☐ ☐ Prequalification standards are different by project class ☐ ☐ Case Study Project Information and Data 1. Project Name and location: 2. Project scope of work: 193

3. Original Total Awarded Value of project: $ Final Total Value of project: $ 4. Date preliminary design contract awarded: Date project advertised: 5. Date final design contract awarded: Date construction contract awarded: [Note: same if DB] 6. Original Project Delivery Period (including design) Final Project Delivery Period (including design) Explanatory notes: 7. Project delivery method used on this project: Design-Bid- Build CM-at- Risk Design- Build P3 Please explain what effect this choice had on the overall quality of the project: 8. Which of the following were reasons why your agency selected the delivery method used for this project? Check all that apply. Reduce/compress/accelerate project delivery period Establish project budget at an early stage of design development Get early construction contractor involvement Encourage innovation Facilitate Value Engineering Encourage price competition (bidding process) Compete different design solutions through the proposal process Redistribute risk Complex project requirements Flexibility needs during construction phase Reduce life cycle costs Provide mechanism for follow-on operations and/or maintenance 194

Innovative financing Other: Explain 9. Which of the above was the single most significant reason for the delivery method decision on this project? 10. Please explain the process that led you to the choice of the project delivery system for this project . Case Study Project Quality Management Policy/Procedures Information: The following questions will break up the quality management process into the following four phases: ♦ Procurement phase: Actions taken regarding the quality management process that are reflected in the agency’s contractor prequalification requirements and/or solicitation documentation such as in the Invitation for Bids (IFB), Request for Qualifications (RFQ) and the Request for Proposals (RFP). ♦ Design Phase (in-house): Actions taken after approval to start design work regarding ensuring the quality of the design deliverables as well as that the final design complies with contractual requirements. OR ♦ Design Phase (out-source): Actions taken after design contract award regarding ensuring the quality of the design deliverables as well as that the final design complies with contractual requirements. ♦ Construction Phase: Actions taken after contract award regarding the quality of the final constructed product to ensure that it complies with both the completed design and other contractual requirements. The research team understands that the term “Approval” has a variety of slightly different meanings from state to state. It is used here to indicate the process by which the agency indicates that it is satisfied with the quality of the design or construction deliverable and is willing to make payment for satisfactory completion of that task if asked. Procurement phase: 1. What procurement method was used to select the designer, builder, or concessionaire? (low bid, best-value, qualifications based selection, etc.) 195

2. Please answer for the case study project. If your process was conducted in more than one way, please answer for the most prevalent set of procedures. Do your project advertising/solicitation documents (i.e. IFB, RFQ, RFP, etc.) contain the following? Required proposal/ bid package submittal? If YES: Is it evaluated to make the award decision? If NO: Is it a required submittal after contract award? Yes No Yes No Yes No Qualifications of the Design Quality Manager ☐ ☐ ☐ ☐ ☐ ☐ Qualifications of the Construction Quality Manager ☐ ☐ ☐ ☐ ☐ ☐ Qualifications of other Quality Management Personnel (design reviewers, construction inspectors, technicians, etc.) ☐ ☐ ☐ ☐ ☐ ☐ Design quality management plan ☐ ☐ ☐ ☐ ☐ ☐ Design quality assurance plan ☐ ☐ ☐ ☐ ☐ ☐ Design quality control plan ☐ ☐ ☐ ☐ ☐ ☐ Construction quality management plan ☐ ☐ ☐ ☐ ☐ ☐ Construction quality assurance plan ☐ ☐ ☐ ☐ ☐ ☐ Construction quality control plan ☐ ☐ ☐ ☐ ☐ ☐ Quality management roles and responsibilities ☐ ☐ ☐ ☐ ☐ ☐ Design criteria checklists ☐ ☐ ☐ ☐ ☐ ☐ Construction testing matrix ☐ ☐ ☐ ☐ ☐ ☐ Quality-based incentive/disincentive features ☐ ☐ ☐ ☐ ☐ ☐ Warranties ☐ ☐ ☐ ☐ ☐ ☐ Optional warranties ☐ ☐ ☐ ☐ ☐ ☐ 3. Was your procurement method selected in part because of its effect on quality management? If so, what effect did the method you chose have on overall project quality? Design Phase: 4. Did this project have a formal design quality assurance program for any design performed in- house? ☐Yes ☐No 5. Did this project have a formal design quality assurance program for design performed by design consultants? ☐Yes ☐No 6. Did this project combine in-house design services with projects delivered by alternative methods (CMGC, DB, P3)? ☐Yes ☐No 196

For this project who performed the following design quality management tasks? (Check all that apply) Does not apply Agency design staff Agency project manage- ment staff Project design consult- ant Project con- struction staff in CMGC, DB, P3 Indepen- dent quality consultan t Other Please specify below Technical review of design deliverables ☐ ☐ ☐ ☐ ☐ ☐ ☐ Checking of design calculations ☐ ☐ ☐ ☐ ☐ ☐ ☐ Checking of quantities ☐ ☐ ☐ ☐ ☐ ☐ ☐ Acceptance of design deliverables ☐ ☐ ☐ ☐ ☐ ☐ ☐ Review of specifications ☐ ☐ ☐ ☐ ☐ ☐ ☐ Approval of final construction plans & other design documents ☐ ☐ ☐ ☐ ☐ ☐ ☐ Approval of progress payments for design progress ☐ ☐ ☐ ☐ ☐ ☐ ☐ Approval of post-award design QM/QA/QC plans ☐ ☐ ☐ ☐ ☐ ☐ ☐ Construction Phase: For this project who performed the following construction quality management tasks? (Check all that apply) Does not apply Agency design staff Agency project manage- ment staff Project design consult- ant Project con- struction staff in CMGC, DB, P3 Indepen- dent quality consultan t Other Please specify below Technical review of construction shop drawings ☐ ☐ ☐ ☐ ☐ ☐ ☐ Technical review of construction material submittals ☐ ☐ ☐ ☐ ☐ ☐ ☐ Checking of pay quantities ☐ ☐ ☐ ☐ ☐ ☐ ☐ Routine construction inspection ☐ ☐ ☐ ☐ ☐ ☐ ☐ Quality control testing ☐ ☐ ☐ ☐ ☐ ☐ ☐ Verification testing ☐ ☐ ☐ ☐ ☐ ☐ ☐ Acceptance testing ☐ ☐ ☐ ☐ ☐ ☐ ☐ Approval of progress payments for construction progress ☐ ☐ ☐ ☐ ☐ ☐ ☐ Approval of construction post-award QM/QA/QC plans ☐ ☐ ☐ ☐ ☐ ☐ ☐ Report of nonconforming work or punchlist. ☐ ☐ ☐ ☐ ☐ ☐ ☐ Quality Management Planning: Please answer the following questions about the project based on your experience. 12. Are the design QM plans used on this project different from the QM plans used on traditional design projects? 197

☐No ☐ Yes If yes, what is the major difference? Click here to enter text. 13. Are the construction QM plans used on this project different from the QM plans used on traditional DBB construction projects? ☐No ☐ Yes If yes, what is the major difference? Click here to enter text. 14. Did the agency mandate the use of standard agency specifications? ☐No ☐ Yes 15. Did the agency mandate the use of standard agency design details? ☐No ☐ Yes 16. Did the agency mandate the use of standard agency construction means and/or methods? ☐No ☐ Yes If no, what was required in their place? 17. Did the agency mandate a specific set of qualifications for the quality management staff of design consultants and construction contractors on this project? ☐No ☐ Yes If yes, what are those qualifications? Click here to enter text. 18. Did your agency utilize contractor quality assurance test results for acceptance on this project? ☐Yes. ☐No. Quality Management Procedures: 2. Do you think that the agency held the CMGC/design-builder/P3 concessionaire’s design/construction quality management staff to a higher standard of care than it sets for its internal staff? ☐Yes ☐No 198

Comments? Click here to enter text. 3. Does your organization have a document that outlines its approach to quality assurance on project? ☐Yes ☐No If yes, was it used on this project? If no, what was used in its place? 4. Does your agency use an approach to quality management that is substantially different than that used by other agencies and might be considered an “alternative QM system”? (i.e. statistical analysis of material test reports that eliminates the need for agency acceptance testing) ☐Yes ☐No Describe: 5. Which of the below best describes your agency’s approach to QA on this project? Interviewer: select appropriate delivery method DBB CMGC DB P3 ☐Design consultant primarily responsible for QA/Agency audits consultant program ☐Contractor primarily responsible for QA/Agency audits contractor program ☐Agency retains traditional QA roles ☐Agency retains an independent party to perform QA roles ☐Agency uses two or more of the above depending on the project ☐None of the above ☐Design consultant primarily responsible for QA/Agency audits consultant program ☐Contractor primarily responsible for QA/Agency audits designers and CMGC’s program ☐Agency retains traditional QA roles ☐Agency retains an independent party to perform QA roles ☐Agency uses two or more of the above depending on the project ☐None of the above ☐Design-builder primarily responsible for QA/Agency audits design-builder’s program ☐Agency retains traditional QA roles ☐Agency retains an independent party to perform QA roles ☐Agency uses two or more of the above depending on the project ☐None of the above ☐Concessionaire primarily responsible for QA/Agency audits concessionaire’s program ☐Agency retains traditional QA roles ☐Agency retains an independent party to perform QA roles ☐Agency uses two or more of the above depending on the project ☐None of the above If “None of the above” was selected, please describe the approach that was used instead: 6. What was the biggest quality challenge in the procurement phase? 199

7. What was the biggest quality challenge in the design phase? 8. What was the biggest quality challenge in the construction phase? 9. Please rate the following factors for their impact on the quality of this project: Factor Very High Impact High Impact Some Impact Slight Impact No Impact Qualifications of agency design staff ☐ ☐ ☐ ☐ ☐ Qualifications of agency project management staff ☐ ☐ ☐ ☐ ☐ Qualifications of agency construction staff ☐ ☐ ☐ ☐ ☐ Qualifications of the design consultant’s staff ☐ ☐ ☐ ☐ ☐ Design consultant’s past project experience ☐ ☐ ☐ ☐ ☐ Qualifications of the construction contractor’s staff ☐ ☐ ☐ ☐ ☐ Construction contractor’s past project experience ☐ ☐ ☐ ☐ ☐ Submittal of Quality management plans prior to work start ☐ ☐ ☐ ☐ ☐ Level of agency involvement in the QM process ☐ ☐ ☐ ☐ ☐ Use of agency specifications and/or design details ☐ ☐ ☐ ☐ ☐ Level of detail expressed in the procurement documents (IFB/RFQ/RFP) ☐ ☐ ☐ ☐ ☐ Use of manuals, standards and specifications developed for DBB type projects ☐ ☐ ☐ ☐ ☐ Allowing flexibility in choice of design standards and construction specifications ☐ ☐ ☐ ☐ ☐ Use of performance criteria/specifications ☐ ☐ ☐ ☐ ☐ Detailed design criteria ☐ ☐ ☐ ☐ ☐ Warranty provisions ☐ ☐ ☐ ☐ ☐ Incentive/disincentive provisions ☐ ☐ ☐ ☐ ☐ Follow-on maintenance provisions ☐ ☐ ☐ ☐ ☐ Innovative financing (PPP/concession) ☐ ☐ ☐ ☐ ☐ 200

C.8 Case Study Selection Matrix Case Study Selection Matrix Delivery Method Procurement Method # Case Study Name State Est. Value (millions) Pilot Design- Bid-Build Design- Build CM/GC PPP No Prequalifications Designer Prequalification Contractor Prequalification 1 Hastings River Bridge MN $ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 2 Willamette River Bridge OR $ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 3 $ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 4 $ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 5 $ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 6 $ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 7 $ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 8 $ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐

TRB’s National Cooperative Highway Research Program (NCHRP) Web-Only Document 212: Alternative Quality Management Systems for Highway Construction documents the research process, data collection and analysis used to develop NCHRP Report 808: Guidebook on Alternative Quality Management Systems for Highway Construction .

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• Study protocol
• Open access
• Published: 04 December 2023

The effect of eye movement desensitization and reprocessing (EMDR) on abdominal pain in patients with irritable bowel syndrome (IBS): a study protocol for a randomized controlled trial (EMDR4IBS)

• B. Wertheim   ORCID: orcid.org/0000-0003-3679-7405 1 ,
• E. E. Aarts 2 ,
• C. de Roos 3 &
• Y. R. van Rood 4  

Trials volume  24 , Article number:  785 ( 2023 ) Cite this article

Metrics details

Irritable bowel syndrome (IBS) is a highly prevalent disorder for which treatment options such as medication, diets, and hypnotherapy either have shown limited effect or relieve symptoms in only a limited subset of patients. Abdominal pain is the key criterion for the diagnosis and is deemed the most distressing IBS symptom, and the most disruptive of everyday life. A growing body of research demonstrates the effect of Eye Movement Desensitization and Reprocessing (EMDR) on chronic pain. EMDR is known as a safe and successful treatment for disorders in which unresolved traumatic memories play a role in the cause or maintenance of symptoms. In IBS, activated memories may increase pain through pain flashbacks and the stress generated by unresolved memories. The aim of this study is to ascertain whether applying EMDR to traumatic memories including pain memories will reduce abdominal pain in IBS patients.

This study is a randomized controlled trial which will be conducted at a city hospital in the Netherlands. Adult patients with considerable IBS pain (pain intensity at least 60/100 during at least 5/10 days) will be randomly assigned to either EMDR therapy or the wait list. We aim to include 34 participants. The EMDR condition comprises seven sessions, around 90 min in length delivered weekly, the first of which is a case conceptualization session. All participants will be assessed at baseline, post-treatment, and at 3 months follow-up. The primary outcome measure is pain intensity on a Likert scale which is self-reported daily during a 2-week period. Secondary outcomes include similar daily ratings on other IBS symptoms and reported hindrance of valued activities, and also standardized questionnaires on IBS symptoms and Quality of Life. Data will be analyzed by a Linear Mixed Effects Model for repeated measures.

The results are expected to gain insight into the effectiveness of EMDR treatment on abdominal pain in IBS. As there are very few effective treatment options for IBS-related abdominal pain, this study could have important implications for clinical practice.

Trial registration

Human ethics committee MEC-U NL71740.100.20. International Clinical Trial Registry Platform: NL8894. Prospectively registered on 28 January 2020.

Peer Review reports

Administrative information

Note: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/ ).

Introduction

Background and rationale {6a}.

Irritable bowel syndrome (IBS) is a common chronic disorder of brain-gut interaction. Its etiology is most likely multi-factorial involving biological, psychological, and social factors. The self-reported prevalence of IBS in the Netherlands is 15–20% in women and 5–20% in men [ 1 ]. Not only do symptoms of IBS have great impact on the individual’s quality of life [ 2 ], but it also causes a significant burden to the health care system and society at large [ 3 ]. The Rome criteria are developed and updated by an international group of experts and are used to diagnose IBS in clinical care and clinical trials. The Rome IV criteria [ 4 ] for IBS feature altered bowel habits and stool changes, but the key criterion, and a requirement for the diagnosis, is “frequent abdominal pain”.

IBS pain is often described as sharp, stabbing, cramping, or throbbing. Pain intensity may be continuous or change throughout the day, the unpredictability making it difficult to plan activities (either social or work-related).

Abdominal pain has been found to be the most distressing IBS symptom, as well as the most disruptive, having a great impact on the quality of life [ 5 , 6 ]. Up to 16% of IBS patients in secondary care have contemplated suicide, because of symptom severity, i.e., pain intensity, interference with life, and lack of effective treatment [ 7 ]. Conventional pain medication is not suitable for treating IBS pain [ 8 ]. The effectiveness of drugs such as NSAIDs or opiates in alleviating IBS pain is low, and they have considerable side effects, sometimes even aggravating pain in the long run. Although other treatment options such as diets, laxatives, and antispasmodics can relieve pain in some patients, in general, patients are dissatisfied with their overall efficacy and tolerability [ 9 ]. This has led the Dutch IBS guideline for General Practitioners to center its recommendations on educating the patient, reducing anxiety and avoidance behaviors, and promoting healthy life style choices. In cases of a severely reduced quality of life, the guideline suggests either antidepressants or psychological treatment [ 10 ]. Often, patients prefer the last option. Of these psychological treatments for IBS, so far, hypnotherapy appears to be most effective in pain reduction [ 11 , 12 , 13 , 14 , 15 , 16 ]. However, a review shows that response rates found in different studies vary widely [ 14 ]. Hence, the search for effective treatments of abdominal pain in IBS continues.

In the last decades, there has been a growing body of research on the effect of eye movement desensitization and reprocessing (EMDR) on chronic pain. EMDR is known as a successful and widely embraced treatment for post-traumatic stress disorder (PTSD) and other disorders in which unresolved traumatic memories play a role in the cause or maintenance of symptoms [ 17 , 18 , 19 ]. Four systematic reviews, published in 2009, 2014, 2016, and 2019 [ 20 , 21 , 22 , 23 ], conclude that EMDR is an effective treatment for chronic pain. Clinical practice and several published case studies established that traumatic experiences involving physical pain can cause pain flashbacks. These pain flashbacks are usually very similar to the original pain in terms of location and quality [ 24 , 25 , 26 , 27 ] and can be triggered by both internal and external trauma-related cues. Activated pain memories can maintain current pain through pain flashbacks and the stress generated by unresolved memories [ 28 ].

Research into the pathogenesis of abdominal pain in IBS appears to confirm this notion. In IBS, neurobiological research has shown altered processing of signals along the gut-brain axis. These changes appear to be related to pain-related expectations and learning processes [ 29 ]. It is suggested that when interoceptive memories of aversive visceral states develop, they may allow the brain to recall visceral experiences of pain in the form of constant or recurrent pain [ 30 ].

A successful EMDR treatment in PTSD helps patients (re)process traumatic memories, thereby reducing memory vividness, emotionality, and hypervigilance. In (re)processing the traumatic pain memories, we expect to reduce their chronic (re)activation, optimizing the circumstances for recovery and thereby reducing pain intensity. We designed this study to ascertain whether applying EMDR to traumatic memories including pain-related memories will reduce abdominal pain in IBS patients. Although clinical practice shows promising results, to our knowledge, no research into the effect of EMDR on abdominal pain in IBS has been conducted.

Objectives {7}

The primary objective of this study is to assess the effect of EMDR treatment on abdominal pain in IBS. It is hypothesized that participants in the EMDR treatment condition will show a greater reduction in abdominal pain intensity than those in the wait-list control group.

Our secondary objectives are to determine the effects of EMDR treatment on (1) other salient IBS symptoms (personalized), (2) overall severity of IBS-related symptoms, (3) the hindrance of valued activities caused by abdominal pain (personalized), (4) quality of life, and (5) the reported rate of adequate relief from IBS symptoms.

It is hypothesized that EMDR treatment will, as compared to the wait-list control condition, lead to a significantly greater reduction of salient symptoms, the overall severity of IBS symptoms, and the experienced hindrance of valued activities. Furthermore, we hypothesize that quality of life will show greater improvement in the treatment condition (EMDR) than in the wait-list control condition, and that after treatment and at follow-up, a higher percentage of patients in the treatment condition (EMDR) will indicate experiencing “adequate relief” of IBS symptoms than in the wait-list control condition.

Trial design {8}

The present study is a superiority study comparing the EMDR intervention with a wait-list control group in a two-armed randomized controlled trial. Patients will be randomly allocated to either EMDR treatment or wait list, with an equal allocation ratio. Blinding for the intervention is not possible.

This study is registered at The Netherlands Trial Register, with registration number NL8894. It is thereby automatically included in the International Clinical Trial Registry Platform.

For an overview of the study design, including recruitment, random allocation, assessments, and treatment, see Fig.  1 .

Inclusion flowchart

Methods: participants, interventions, and outcomes

Study setting {9}.

Participants will be recruited from the general hospital Diakonessenhuis, Utrecht area in the Netherlands.

Eligibility criteria {10}

Detailed inclusion and exclusion criteria are listed in Table 1 .

Subjects are eligible for participation if they meet Rome IV criteria for IBS and report severe pain intensity at least half of the time. Severity of pain is measured by the self-reported pain intensity score on the Irritable Bowel Syndrome—Severity Scoring System (IBS-SSS). A pain intensity score of 60 or more on a scale of 0–100 is considered to reflect “severe pain.”

The Rome IV criteria [ 4 ] are:

Recurrent abdominal pain, on average, at least 1 day/week in the last 3 months, associated with two or more of the following:

Related to defecation

Associated with a change in frequency of stool

Associated with a change in form (appearance) of stool.

Criteria need to be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.

Participants are allowed to continue any prior IBS treatment such as medication or a diet as long as they agree not to change these during the trial.

Treatment will be administered by qualified psychologists who have been included in the Dutch legal register for Professions in Individual Health Care (BIG-register) and are at least EMDR Europe accredited level 1 trained in EMDR therapy.

Who will take informed consent? {26a}

The gastroenterologist establishes whether subjects meet Rome IV criteria for IBS. Afterwards, they complete a short questionnaire comprised of the IBS-SSS (short form) to which this question is added: May we invite you to participate in a scientific study of a new treatment for IBS?

Subjects meeting the initial criteria (pain intensity and frequency) receive, by post, the Patient Information Form packet (PIF) approved by the Medical Ethical Committee. About a week later the principal investigator calls the subject to answer questions that may have arisen and to screen for exclusion criteria. If the subject meets inclusion criteria, does not meet exclusion criteria, and is willing to participate, he or she fills out and signs the consent form included in the PIF and sends it to the principal investigator in the included return envelope.

Additional consent provisions for collection and use of participant data and biological specimens {26b}

Standard items in the consent form state that the participant agrees that

he or she has been informed satisfactorily about the study and that enough time was given to form a well-founded opinion on participation.

he or she has chosen to participate voluntarily, and he or she is free to stop participation without having to give a reason.

she knows she cannot participate when pregnant.

and agrees to

the principal investigator informing both their gastroenterologist and general practitioner of their participation in the study and of any unexpected findings concerning their health.

the collection of data in order to answer the study’s research questions.

allow the study process controllers specified in PIF, access to their data.

the therapy sessions being videotaped to check for treatment adherence and fidelity.

Additionally, the participant is asked to state whether they consent to

being recognizable in de session video tapes.

their personal information and data being used in future studies on either EMDR or IBS.

being approached, after this study, to participate in follow-up research.

Interventions

Explanation for the choice of comparators {6b}.

So far, no scientific research has been done to study the effect of EMDR on pain in IBS. We choose to compare the intervention group with a wait-list control group. Comparison to an active control group such as gut-directed hypnotherapy or psychoeducation would require a larger sample size than we have the means to carry out. The same restrictions in time and resources prevent us from arranging an inactive control condition.

Intervention description {11a}

EMDR treatment is based on the eight phases of the EMDR standard protocol [ 31 , 32 , 33 ]. Listed below are the principal steps in each phase.

History taking: taking history, making a case conceptualization based on the information gathered, and compiling a list of traumatic experiences.

Client preparation: explanation of the theory behind EMDR, the introduction of the eye-movement task and tactile and auditory tasks (buzzers, clicks), answering questions, in general preparing the client for EMDR.

Assessment: the memory that will be processed in the session is decided on. The target image (the most distressing image of the memory) is identified, as well as the principal negative belief, feelings, and sensations linked to the memory. Also, a positive cognition is chosen. Baseline measures are established for the credibility of this positive cognition (Validity of Cognition, VoC), and the amount of stress generated by the target (Subjective Units of Distress, SUD).

Desensitization: taxing working memory while focusing on the target, by applying eye movements, until the SUD score is zero.

Installation: strengthening of the positive belief until it feels true.

Body scan: the therapist asks the client to bring the original target to mind and check for any residual tension in their body. If so, these physical sensations are then targeted for reprocessing.

Closure: consolidation of the positive effects (whether the reprocessing is complete or not), instructions for between sessions and how to reach the therapist when needed.

Reevaluation of treatment effect: takes place at the beginning of each new session, to check whether the SUD of previous targets is still low.

After that another memory from the trauma list is chosen, for which the procedure is repeated from phase 3.

A special kind of target is the flash forward, which does not involve a memory, but an image representing a dreaded event in the future. Interweaves can be used when the reprocessing process is blocked or loops. Extra tasks taxing working memory can be used in case of high-stress levels of abreaction.

In this study, the intervention consists of seven weekly 90-min sessions, which include:

An intake in which onset, severity, frequency, and impact of IBS symptoms are explored and an overview is made of all the traumatic events related to the onset and/or maintenance of the abdominal pain or negative experiences with the pain. Both PTSD A criterion events such as rape or car accident and adverse events that are not life-threatening such as bouts of severe abdominal pain or instances of (near) defecation in public are included in the overview. Based on the acquired information, a case conceptualization is made, from which the memories to be processed are selected. This concludes phases 1 and 2 of the EMDR standard protocol.

Six sessions of EMDR lasting 90 min each in which phases 3 to 8 of the EMDR standard protocol [ 31 , 32 , 33 ] are applied to the selected memories. In addition to the customary sets of rapid eye movements, tactile and auditory input (buzzers and beeps) may be applied to optimally tax working memory. During the EMDR sessions, the therapist will direct extra focus/attention to physical sensations, usually abdominal sensations. If relevant, a flash forward will be desensitized. Interweaves will be applied if necessary. Successful desensitization is defined as the reaching of SUD = 0 (Subjective Units of Distress; the recollection of the event no longer causes the subject any distress). If severe abdominal pain remains after having processed all relevant targets, the pain itself will become the focus of the next EMDR session. Treatment is ended either after six 90-min sessions, or when all relevant memories have been successfully desensitized.

Treatment takes place face-to-face. However, if necessary due to quarantine during the COVID-19 pandemic, it can also be offered online via video consultation. Although as yet little is known about the effectiveness of online EMDR treatment for PTSD, so far results are promising that effects may be similar to real-life EMDR treatment [ 34 ].

Criteria for discontinuing or modifying allocated interventions {11b}

With acquiring new information during sessions, the case conceptualization can change a little, which in turn can change the selection of memories to be processed. The EMDR treatment in itself will not be altered.

Patients are free to withdraw from partaking in the study at any time. The research team can decide to remove a patient from the study if.

There are serious medical reasons.

The subject fails to complete the questionnaire(s) during the first period of measurements.

The subject fails to appear at a treatment session more than twice (without notice).

The subject’s non-cooperation seriously hinders treatment.

Subject meets an exclusion criterion along the way (e.g., becomes pregnant or an intestinal disease is diagnosed).

There are persistent serious side effects.

Like all studies involving human subjects, we are required to report serious adverse events as defined by the Central Committee on Research Involving Human Subjects (in Dutch: CCMO, Centrale Commissie Mensgebonden Onderzoek).

No serious adverse effects have been found in studies of EMDR in diverse populations. Some discomfort—both physical and psychological—both during sessions and in the first 4 days after an EMDR session is not unusual. As this is part of the psychological process of processing negative memories, this is no cause for discontinuing the intervention.

Any unexpected adverse effects will be discussed within the research team, which includes two EMDR Europe registered EMDR consultants with extended expertise. Depending on the outcome of this deliberation, steps will be taken to reduce the adverse effects. If necessary, participation in the study will be temporarily interrupted. If the adverse effects persist, participation in the study will be discontinued.

Strategies to improve adherence to interventions {11c}

Prior to the inclusion of a participant, an explanation about EMDR therapy is given in the Patient Information Form and, if desired, questions are answered during the telephone call in which exclusion criteria are checked. Again, later, during the intake subjects are informed thoroughly about what to expect during and after an EMDR treatment session. This increases motivation and adherence to the therapy once treatment has started.

Beforehand, trial therapists are required to demonstrate their competence in applying the treatment. As yet, there are three trial therapists, but more may be added later. To ensure treatment quality and adherence to the EMDR standard protocol, the therapists receive monthly supervision sessions by the EMDR consultants based on the EMDR treatment sessions videotaped during the study. Furthermore, weekly session checklists are viewed by the consultants to closely follow the EMDR process. Any questions by the therapists will be answered before the next session. Also, every session is videotaped to enable regular fidelity checks. Fifteen percent of all recorded sessions will be reviewed for treatment fidelity using the Treatment Integrity Checklist for EMDR. Fidelity checks will be done at random, by the last author (YvR), who is an EMDR Europe registered EMDR consultant with extended expertise.

Relevant concomitant care permitted or prohibited during the trial {11d}

Concurrent treatment for psychotrauma is an exclusion criterion. Upon entering the study, participants agree to refrain from starting other treatments (medication, nutritional supplements) or behavioral changes (e.g., diet) aimed at the IBS symptoms.

Treatments and diets that are already part of the patients’ customary regimen can be continued. We ask subjects to report any changes in their prescribed medication. At three measurement moments, subjects are explicitly asked about their current medication use.

Provisions for post-trial care {30}

Subjects from both the intervention and wait-list control group will after the end of the study meet with the principal investigator to determine if there is (still) a wish or need for treatment for the IBS symptoms. If so, they are offered treatment appropriate to their current situation, provided that this can be offered by the Department of Clinical Psychology of the Diakonessenhuis. In some cases, referral to mental healthcare may be the best course of action.

No harm is expected to occur from participating in the study and the medical ethical committee has agreed to grant an exemption for an insurance for the participants of the study. The hospital, however, has, as required by law, a liability insurance for compensation of those who suffer from harm incurred in the hospital.

Outcomes {12}

The primary outcome of this study is the intensity of abdominal pain. As the intensity of abdominal pain in IBS can vary greatly from day to day, we have chosen to pose the same question each day for 2 weeks. Participants answer the question: “How much did you suffer from abdominal pain during the last 24 h?”. The subject’s answer is given on a 21-point Likert scale (0 = no pain, 10 = worst pain imaginable, half points possible).

In addition to the primary outcome measure (abdominal pain), we pose four other diary questions at the same time, during the same period, with the same 21-point Likert scale. Based on their statements at inclusion about their principal IBS symptoms, we ask about their top two symptoms (abdominal pain excluded): “How much did you suffer from (complaint) during the last 24 h?” (0 = not at all, 10 = extreme suffering, half points are possible). These symptoms could be frequently occurring IBS symptoms such as diarrhea, constipation, and bloating, but they can also be more idiosyncratic such as dizziness. We also ask about the hindrance subjects have experienced from their IBS symptoms when engaging in everyday activities. Based on their statements at inclusion about the two- valued activities that are most impeded by the IBS symptoms, we ask for every one of these activities: “How much hindrance have you experienced from your IBS symptoms when engaging in this activity?” (0 = no hindrance at all, 10 = made completely impossible; half points possible). Activities most likely to be impeded by IBS symptoms are working, doing sports, going out for dinner, and going out (dancing, theatre, etc.).

The 14-day-sequence of these 5 “diary questions” is administered at inclusion, 8 weeks after inclusion (for the intervention condition this means after treatment), and at follow-up (20 weeks after inclusion, 3 months after treatment).

In addition to the diary questions, we administer several questionnaires, the purpose of which is to describe the population and to either confirm or disconfirm the results of the diary questions. They also enable comparing outcomes with those of other studies. The questionnaires are administered on the last day of every 14-day-sequence of diary questions.

The questionnaires administered are:

IBS-SSS (Irritable Bowel Syndrome—Severity Scoring System) [ 35 ].

The first part of this questionnaire consists of 5 questions regarding the frequency and intensity of pain, the intensity of bloating, satisfaction with bowel movements, and the impact of IBS on the subject’s life in general. The answer type varies per question (Visual Analog Scale 1–100 or a specific number). Scores can range from 0 to 500 with higher scores indicating more severe symptoms (75–175 mild, 175–300 moderate, > 300 severe). The IBS-SSS severity score is recognized by the Rome Foundation as an appropriate measure for assessing changes in research on treatments [ 36 ]. A decrease of 50 points is considered a clinically relevant improvement.

Part two of the IBS-SSS consists of 5 questions that explore the nature and quality of the symptoms. In this study, only the localization of abdominal pain is addressed.

IBS-QOL (Irritable Bowel Syndrome—Quality of Life measurement) [ 37 ]

This questionnaire measures the impact of IBS on quality of life. It contains 34 statements covering the following 8 areas: Dysphoria, Interference with Activity, Body Image, Health Worry, Food Avoidance, Social Reaction, Sexual, and Relationships. Subjects are asked to indicate to what extent each of these statements applies to them on a 5-point Likert scale (1 = not at all, 5 = very much). The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0–100 scale for ease of interpretation with higher scores indicating better IBS-specific quality of life. In addition to the total score, a scale score can be calculated for each of the 8 areas mentioned. Distribution of the IBS-QOL is managed by the Rome Foundation. Psychometric properties are well established [ 38 ].

AR (Adequate Relief Question)

This is one question: “In the last 7 days, have you had adequate relief of your IBS symptoms?” The answer can be yes or no. The Rome Foundation accepts and recommends this outcome measure in RCTs [ 39 , 40 ]. In this study, AR is included as an outcome measure to allow comparison of our results to those of studies using this recommended outcome measure.

Other questionnaires, not used as outcome measures, but solely administered to describe the population are:

LEC-5 (Life Events Checklist for the DSM-5) [ 41 ]

This questionnaire is a self-report measure designed to screen for potentially traumatic events in a respondent's lifetime. It describes 17 (A criterion) events, and subjects are asked to indicate whether they have experienced such an event and in what way (happened to me, witnessed it, learned about it, part of my job, not sure, doesn’t apply). There is no formal scoring protocol or interpretation per se, other than identifying whether a person has experienced one or more of the events listed. The LEC-5 in combination with the PCL-5 can be used to screen for PTSD.

In this study, the LEC-5 in combination with the PCL-5 is used to screen for PTSD criteria.

PCL-5 (PTSD Checklist for the DSM-5)

This self-report questionnaire consists of 20 items concerning the 20 DSM-5 symptoms of PTSD. For each symptom, subjects are asked to indicate on a Likert scale to what extent they have suffered from it in the past month (0 = not at all, 1 = a little bit, 2 = moderately, 3 = quite a bit, 4 = extremely). A total symptom severity score (range 0–80) can be obtained by adding the scores of the 20 items together. DSM-5 severity scores for the individual symptom clusters can be obtained by summing the scores of the items of a particular cluster. The PCL-5 can be used in combination with the LEC-5 (see below) as a screening tool for PTSD. An indication for a PTSD diagnosis can be obtained by counting any item with a score of 2 (moderate) or higher as a symptom that is present. Then the DSM-5 diagnostic calculation rule is followed to ascertain whether the required criteria are met: a minimum of 1 B-symptom (questions 1–5), 1 C-symptom (questions 6–7), 2 D-symptoms (questions 8–14), and 2 E-symptoms (questions 15–20). The PCL-5 can also be used to determine the course of PTSD symptoms. Results from the USA with the previous version of the PCL (PCL for DSM-IV) suggest that a 5–10-point change indicates a reliable change and a 10–20-point change indicates a clinically significant change [ 42 ].

In this study, the PCL-5 is used to assess the severity of PTSD symptoms.

Diary questions and questionnaires are administered digitally, using an ISO 9001-certified online tool. Subjects receive an e-mail containing a link to the diary questions or the questionnaire, which they then can fill out.

Participant timeline {13}

The recommended schematic diagram is showed in Additional file 1 .

*The intake session takes place the day after the questionnaires, and the other sessions take place on the same day, each a week later. See Fig.  2 for the overview.

Participant timeline overview for both EMDR treatment group and wait-list control

**The questionnaires are administered on the last day of the 2-week diary period.

Sample size {14}

Several factors have influenced the sample size in this study: setting, method of analysis, and the estimate of comparability with previous scientific research.

As the study is conducted as part of the curriculum of a training course taken by the principal investigator, both time and resources are limited. Our aim is to demonstrate a clinically relevant treatment effect regarding the primary outcome measure with a limited sample size.

The design of our study enables us to analyze our primary outcome data (pain score diary) using a linear mixed effects models analysis. Sample size was computed using the online statistical calculation program GLIMMPSE (General Linear Mixed Model Power and Sample Size): https://glimmpse.samplesizeshop.org/#/ using an alpha of 0.05 and a desired minimum power of 0.80.

The most important estimated value required by the GLIMMPSE program is the expected effect size. Since a study on the effect of EMDR on abdominal pain in IBS has never been done before, a search was made for comparable research. A review on EMDR treatment for chronic pain found large effect sizes [ 22 ]. The EMDR for phantom limb pain study design is most comparable to our study design [ 28 ]. Based on this study, a remarkably large effect size d of 1.22 was calculated. On entering this effect size, GLIMMPSE calculated that a sample size of 12 should be sufficient. However, when a demonstration of an average effect size is wanted, a sample size of 24 is needed. This sample size is adequate to analyze the primary outcome measure daily pain scores using a linear mixed effects model. In addition, this sample size is also expected to be adequate to analyze the secondary outcome measures from the standardized questionnaires (measures taken only three times in total) with LME models. Taking drop-out into account we decided to include a maximum of 34 participants.

Recruitment {15}

An agreement has been made with all gastroenterologists and physician assistants in gastroenterology at Diakonessenhuis that—at the end of their consultation—they will issue the initial screening questionnaire to all their outpatients who meet the Rome IV criteria for IBS. This initial screening instrument, which encompasses the first 5 questions of the IBS-SSS, is also used as a routine outcome measurement in gastroenterology for more general purposes. The time invested by the gastroenterologist at the outpatient GI clinic is kept at a minimum, and regular reminders to hand out the screeners are sent to all gastroenterologists.

An initial estimate was made by the liaison gastroenterologist of how many patients are expected to meet the initial criteria. This estimate turned out to be too optimistic; in the first 6 months, about 30 screening questionnaires were filled out. Roughly 25% of these patients ( N  = 7) met the initial inclusion criteria.

Assignment of interventions: allocation

Sequence generation {16a}.

The allocation sequence is generated in advance by using the Excel randomization function. Allocation of treatment vs wait list (control) is 1:1.

Concealment mechanism {16b}

The outcome of the randomization is placed in 34 opaque, sealed envelopes, and the rank number of inclusion is written on the envelope. This is done by an independent person, not involved in the study. The sealed envelopes are kept in a locked cabinet. After receiving informed consent, the participant is assigned an ID number, after which the corresponding envelope is opened. Once allocated to either treatment or wait-list condition, blinding is no longer possible.

Implementation {16c}

An independent person generates the allocation sequence and prepares and keeps the sealed envelopes. The main investigator will obtain the next sealed envelope from this person after informed consent was given. The note of allocation (treatment or control) and the numbered envelope are attached to the informed consent form. The main investigator then informs the participant about allocation. Allocation to a specific therapist depends mostly on the therapists’ schedules and timing of enrollment.

Assignment of interventions: blinding

Who will be blinded {17a}.

Blinding to treatment is impossible for both participants and therapists. Treatment allocation is not discussed with the research assistant who gathers the data from the online tool (Exploratio), unless circumstances demand it. For example, the timing of questionnaires has to be changed when a treatment session was missed. The statistician engaged to perform the analysis is blinded to treatment allocation.

Procedure for unblinding if needed {17b}

Not applicable, because blinding to treatment is impossible in the first place.

Data collection and management

Plans for assessment and collection of outcomes {18a}.

All outcome measures are self-report questionnaires (see Outcomes {12}), which are administered via an online tool. The coded data will be extracted from the tool and saved “as is” to the secure research archive.

The diary questions and questionnaires used are described in the Outcomes section {12}.

More information on the questionnaires administered can be found in Table 2 .

Plans to promote participant retention and complete follow-up {18b}

In the first conversation on the telephone, the principal investigator establishes a positive atmosphere, in which the candidate feels free to ask questions and discuss any misgivings they might have. After the candidate has decided to participate, the investigator relates the particulars about data collection. Content (diary questions), timing, and the limited time required to fill out the questions/questionnaires of assessment are discussed. Participants are also informed that they will receive a reminder (by telephone call) from the research assistant when the diary questions or questionnaires are not filled out by a specific time in the evening. This specific time is chosen in agreement with the participant. The investigator notifies the participant that an evaluation interview will take place after data collection, in which study participation will be reviewed, and participant’s wishes concerning further treatment will be discussed. Also, participants are informed that they will receive a compensation of €25 when all questions and questionnaires have been filled out, and that participants in the treatment condition will receive a contribution for their travel costs of €6 for each visit.

The principal investigator encourages the participant to contact her with any questions or difficulties they might have filling out the diary questions or questionnaires.

When a participant has forgotten to answer the diary questions, or to fill out the questionnaires, the research assistant calls them and kindly reminds them of the e-mail, and asks them to fill out the questionnaire. A friendly atmosphere in these calls is essential.

Data management {19}

Each participant will be allotted a unique ID number. The data from the diary questions and questionnaires are gathered using a secure connection and are stored in an online, password-protected, secured database that is only accessible by the researchers. The data are extracted and saved to the research archive coded with the unique identification number, first in their original format (separately for each participant and each day), and after that data are imported to the overall data collection file in Excel. The original format files serve as a backup. The data will be monitored for consistency and validity (e.g., check for errors, range checks, missing values) at collection by the research assistant and later by the principal investigator. The overall data file will be exported to the statistical analysis program.

Any other data will be stored under the identification number only. The coding list with identification numbers and names and the informed consent forms will be kept separate and secured by the principal investigator.

Data from diary questions, questionnaires, and treatment sessions’ video footage will be kept for 15 years, and patient files (intervention group) will be kept for 20 years in accordance with national law. Modifications to this protocol will be submitted to the approving ethical committee and the institutional review board.

Confidentiality {27}

Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}.

No biological specimens are gathered in this study.

Statistical methods

Statistical methods for primary and secondary outcomes {20a}.

The statistical analyses will be performed according to the intention-to-treat principle.

The primary outcome measure in this study is the reported intensity of abdominal pain, which is registered during 14-day periods of daily diary questions, at three points in time, yielding 42 data points per participant.

The principal research question will be answered by performing a linear mixed effect models analysis, based on 2 groups (treatment and control) and 3 (baseline, after treatment, follow-up) × 14 (days) measuring moments. Before the analysis, data will be checked for outliers and the assumption of linear relations. Values with an absolute z -score > 4 will be treated as outliers and removed.

The model will be built in a stepwise model, first fitting an intercept-only linear mixed effects model, allowing to disentangle variance between patients and variance within patients over time. In a second step, the predictor time will be added, to control for any unexplained changes over time in subsequent models. If necessary, a quadratic term for time will be added to the model as well. Subsequently, in the third model, the fixed effect for condition will be added. In the fourth model, the fixed effect for measurement period (baseline, treatment, and follow-up) will be added (note, this variable will represent the difference between baseline and treatment period and baseline and follow-up period irrespective of condition). In the sixth model, the difference between measurement periods will be allowed to vary over patients (a so-called random slope for measurement period). If this is significant, in a seventh model, an interaction between measurement period and condition will be included, to explain why the differences between periods vary over patients. This last term, the interaction between measurement period and condition, answers our primary research question: what is the overall difference in changes in pain score over measurement periods between condition and control group?

After performing the analysis, the assumption of normally distributed errors for both level 1 and level 2 errors will be assessed.

As to the secondary outcome measures: the data gathered from the residual diary questions (pertaining to other IBS symptoms and hindrances experienced in valued activities) are analyzed in the same way as the primary outcome (abdominal pain intensity).

The outcome measures from the two standardized questionnaires, which only yield 3 data points, will be analyzed by LME models based on 2 groups (treatment and control) and 3 measuring moments (at baseline, after treatment, and at follow-up). See Fig.  2 .

For all analyses regarding symptom improvement, a one-sided significance threshold of alpha = 0.05 will be used. For all other analyses, a two-sided p value of 0.05 will be used as the significance threshold. We will report both p -values and 95% confidence intervals.

Based on the Adequate Relief Question, and based on the presence of a clinically relevant reduction of symptoms as measured by the IBS-SSS, a Number Needed to treat will be calculated, for two measuring moments: after treatment and at follow-up.

Interim analyses {21b}

No interim analyses or other stopping guidelines will be applied.

Methods for additional analyses (e.g., subgroup analyses) {20b}

If the collected sample size allows it, it will be investigated whether observed differences between patients in treatment effect can be explained by other variables such as sex, age, symptom severity at baseline, the severity of PTSD-related symptoms at baseline, and the number of other ongoing treatments (such as diets, etc.).

In describing the study population, the following data will be reported:

The frequency of reported IBS symptoms and valued activities (as reported at initial screening).

The percentage of patients that meet the criteria for PTSD (as determined by LEC-5 and PCL-5 results).

Average and standard deviation scores on PCL-5, per group and per measuring moment.

The number of patients that have experienced additional traumatic experiences during the time of participation.

Chi-square tests or t -tests will be done to test for a priori differences between the intervention and control group regarding demographic and descriptive values. Both p values and standardized differences will be reported.

Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}

Every effort is made to avoid missing data. The way the diary questions and questionnaires are administered online makes it impossible to skip a question. Also, patients who do not complete a questionnaire or diary will receive one or more reminders.

For all analyses, a linear mixed effects model (LMEm) analysis is used. The advantage of linear mixed effects modeling is that the analysis can be performed on all data available, and missing data is handled automatically assuming Missing at Random (MAR) without requiring imputations.

Plans to give access to the full protocol, participant-level data, and statistical code {31c}

Statistical code will be made available through a publication via https://zenodo.org/ .

See {31a} for further information.

Oversight and monitoring

Composition of the coordinating center and trial steering committee {5d}.

As this is a small mono-center study. The study board which acts as a steering committee consists of only two people, the principal investigator and the primary EMDR consultant. The study board meets every month and reviews the progress of the study. Final decisions on changes to the protocol, publications, and reporting will be made by the study board.

The principal investigator keeps in regular contact with the gastroenterologists, research assistant, and trial therapists and provides them with day-to-day support.

This study will not be audited by independent auditors. There is also no data monitoring committee as the study involves minimal risk. The intervention (EMDR) is part of regular care.

Composition of the data monitoring committee, its role and reporting structure {21a}

Adverse event reporting and harms {22}.

The research protocol, including plans for managing adverse events, has been reviewed and approved by the human ethics and research committee MEC-U (reference number: NL71740.100.20).

As is usual when applying psychological interventions, patients may temporarily experience mild reactions such as fatigue and heightened emotionality, which is seen as the result of the ongoing effect of the intervention.

Any serious adverse effects (SAEs) as defined by the Central Committee on Research Involving Human Subjects (CCMO in Dutch) will be documented and reported immediately to the principal investigator. It will be determined whether the SAE is related to any trial procedure or intervention.

Frequency and plans for auditing trial conduct {23}

The study will not be audited by independent auditors. To this, the human ethics and research committee MEC-U has given its assent.

Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25}

Any protocol modifications which may affect the conduct of the study or patient safety require formal amendments to the protocol. These will be agreed to by the study board and must be approved by the MEC-U ethics committee and the institutional review board prior to implementation. The results of amendments will be communicated to trial participants if relevant.

Minor changes to the protocol (e.g., corrections, clarifications that have no effect on the way the study is conducted) will be agreed upon by the study board.

Dissemination plans {31a}

After completion of the study, the results will be submitted for publication to a peer-reviewed scientific journal, regardless of the direction or magnitude of effects. Also, we intend to present the results at relevant research conferences, and in (inter)national publications. And finally, if results warrant it, they will be used for educational and training purposes.

The institutions providing grants will not impose restrictions on publication.

Participants will receive the final trial report on request, as well as any other parties who have shown an interest (such as the participants’ general practitioners). Also, participants will be offered an overview of their own results on several outcome measures.

The research protocol, data, and statistical code supporting the findings of the final trial report will be available on request, if deemed reasonable and in accordance with the EU general data protection regulation.

The investigators involved and the statistician engaged for the analysis will be named as (co-) authors of the publication of the final trial report.

This article described the study protocol of a hospital-based RCT on EMDR and wait-list control in IBS patients. The primary aim of the study is to gain insight into the effect of EMDR treatment on abdominal pain in patients with IBS. As IBS is a highly prevalent condition, and there are very few effective and acceptable treatment options for IBS in general, and for IBS-related abdominal pain specifically, this study could have important implications for clinical practice. If we find that EMDR is indeed effective in reducing abdominal pain in IBS, this study may contribute to important advances in the psychological treatment of patients with IBS and thereby might have considerable positive impact on both the individual lives of IBS sufferers and the societal burden that IBS causes.

This study has several strengths. First, to our knowledge, this study will be the first to investigate the effectiveness of EMDR on abdominal pain in IBS in a randomized controlled trial. The association between PTSD and IBS has been well established in various populations [ 43 ] and suggestions have been made to expand research into the effect of psychological treatments on IBS symptoms [ 44 ]. Two case studies have been published that show that trauma-focused treatment can alleviate IBS symptoms [ 45 , 46 ], but more systematical and empirical studies are lacking.

Second, we have chosen our various outcome measures to optimize information yield. In the population of IBS sufferers, symptoms tend to vary over time and main symptoms differ per person [ 9 , 20 ]. To address this problem, we chose to (1) gather data points over an extended period of time (i.e., 2 weeks at baseline, after treatment, and at follow-up) and (2) personalize secondary outcome measures. This provides us with an accurate representation of symptoms and does justice to what is important to the participant. However, to enable comparison to other studies in the IBS realm, several standardized questionnaires are administered that are widely used and recommended [ 47 ] in IBS research: the IBS-Severity Scoring System, the IBS-Quality of Life measure, and the IBS-Adequate Relief question. From the IBS-SSS, two measures can be gleaned: (1) the numeric overall score and (2) a dichotomic score of clinically significant improvement of symptoms (50 points reduction of the overall score is considered to represent a clinically relevant improvement) [ 35 ].

Third, inclusion in the study will be shortly after being seen by the gastroenterologist. This assures that participants are representative of the patient population referred to secondary care. As the population and conditions reflect clinical practice, generalizability of the results of the study to routine clinical practice is enhanced. Lastly, treatment integrity is ensured by intensive supervision by experts and regular fidelity checks.

There are also some limitations to this study that should be considered. First, our wait-list control condition does not allow us to rule out a positive effect of “therapist contact” on participants’ abdominal pain. Designing an adequate control intervention in research on the effectiveness of psychological treatments is difficult [ 36 , 48 ]. A proper placebo condition has all components of the experimental treatment, except the actual operating mechanism of this treatment. In psychotherapeutic interventions, all non-specific components of treatment such as time, attention, and contact with therapist should be integrated into the control condition [ 49 ]. Moreover, a control intervention which the participants would not consider credible can have a negative impact on the study results and participant motivation causing dropout [ 48 ].

Alternatively, comparing EMDR to an active control group, such as gut-directed hypnotherapy or psychoeducation would supply information on the relative efficacy of these treatments.

Due to restrictions in time and resources, we are forced to choose a design that allows us to keep within feasible limits. A proper placebo condition would require more time and resources than we have available. The same applies to the comparison to an active control condition, which would require a larger sample size.

Second, we cannot adjust optimally for a placebo effect. The placebo response in RCTs in IBS is estimated to be considerable [ 50 , 51 ]. Several recommendations have been made to diminish the effect of placebo response on outcomes of RCTs [ 49 , 52 , 53 ]. We have managed to follow (or nearly follow) the recommendations as to the length of follow-up, the duration of treatment, and using stringent inclusion criteria, but blinding to treatment is impossible, and we have not distinguished between subgroups of IBS (predominant constipation, diarrhea or mixed), or included biomarkers as outcome measures.

Third, it is likely that our sample reflects a selection bias based on the acceptability of the intervention. Medical treatments such as tablets or diet were found to be easily acceptable to most IBS patients, but psychological intervention may not be as readily acceptable to everyone [ 54 ]. Both acceptability and credibility of psychological treatment for Persistent Physical Symptoms (formerly Medically Unexplained Symptoms, MUS) are found to be important for successful implementation [ 55 ]. It has been suggested that it is crucial that doctors communicate to their patients that attention to psychosocial factors does not preclude vigilance to physical disease. This reduces anxiety about missing a medical problem and enhances the patients’ willingness to accept a biopsychosocial explanation for their symptoms [ 56 ]. It may very well enhance the acceptability of psychological treatment as well. In further research, the addition of this assurance by the gastroenterologist may decrease selection bias.

In conclusion, the results of this randomized controlled trial, evaluating the effectiveness of EMDR treatment on abdominal pain in IBS, will contribute to the advancement of IBS management.

Trial status

Protocol version 2.7 date of approval MEC-U 22–12-2021. Recruitment has started in June 2020 and is still ongoing. The estimated date of completing the recruitment is December 31, 2023.

Availability of data and materials {29}

The research protocol, final trial dataset, and statistical code supporting the findings of the final trial report will be available on request, if deemed reasonable and in accordance with the EU general data protection regulation.

Abbreviations

Adequate Relief Question

Dutch legal register for Professions in Individual Health Care

Central Committee on Research Involving Human Subjects in the Netherlands

Diagnostic and Statistical Manual of Mental Disorders, fifth edition

• Eye movement desensitization and reprocessing

European Union

General Linear Mixed Model Power and Sample Size website

• Irritable bowel syndrome

Irritable Bowel Syndrome Severity Scoring System

Irritable Bowel Syndrome Quality of Life measure

Identification number

Imaginary Exposure

Life Events Checklist for the DSM 5

Linear mixed effect model

Medical Research Ethics Committees United

Medically Unexplained Symptoms

Non-steroid anti-inflammatory drugs

PTSD Checklist for the DSM 5

Patient Information Form packet

Persistent Physical Symptoms

Post-traumatic stress disorder

• Quality of life

Programming language and software for statistical analysis

Randomized controlled trial

Subjective Units of Distress

Trauma-focused Cognitive Behavioral Therapy

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Acknowledgements

We would like to thank all participants, the research assistant (Ellen Smits), trial therapists (Marieke Fonk, Michelle Emons), gastroenterologists and physician assistants (especially Suzanne Jeurnink and Hester Straver), gastroenterology secretaries, and Paulien Daudeij, the secretary to the department of Clinical Psychology at Diakonessenhuis. We also thank Mirjam Moerman for her contribution to the first draft of the planned statistical analysis and estimate of sample size, and Bregje Wertheim for additional support with script preparation in R. We are thankful to the Vereniging EMDR Nederland and the Stichting Vrienden van het Diakonessenhuis for funding the study and to the Diakonessenhuis Utrecht and its science desk for supporting the research within the hospital setting. We also thank the Rome Foundation for graciously allowing us to add the IBS-QOL to our set of outcome measures.

This study is supported by grants from the Vereniging EMDR Nederland and the Stichting Vrienden van het Diakonessenhuis awarded to the principal investigator BW. These funding sources had no role in the design of this study and will not have any role during its execution; collection, analyses, and interpretation of the data; or decision to submit results.

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BW is the principal investigator; she conceived the study in close collaboration with YvR and CdR, designed the trial, and provided the main preparation of the study documents together with YvR. BW applied for the grant funding, under the supervision of YvR. She also prepared and implemented the method for data collection. CdR provided added expertise concerning EMDR therapy. EA checked sample size calculations, designed the plan for statistical analysis, and assisted in formulating subheadings of the paper concerning statistical analysis and reporting results. BW drafted the paper under the supervision of YvR. All authors provided editorial input and read and approved the final manuscript.

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Wertheim, B., Aarts, E.E., de Roos, C. et al. The effect of eye movement desensitization and reprocessing (EMDR) on abdominal pain in patients with irritable bowel syndrome (IBS): a study protocol for a randomized controlled trial (EMDR4IBS). Trials 24 , 785 (2023). https://doi.org/10.1186/s13063-023-07784-1

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Study Protocol

Investigating social determinants of child health and their implications in reducing pediatric traumatic injury: A framework and 17-year retrospective case-control study protocol

Contributed equally to this work with: Hunter Goodon, Justin Gawaziuk, Brenda Comaskey, Sarvesh Logsetty, Rae Spiwak

Roles Formal analysis, Methodology, Writing – original draft, Writing – review & editing

Affiliation Department of Surgery, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada

Roles Conceptualization, Formal analysis, Methodology, Writing – original draft, Writing – review & editing

Roles Writing – original draft, Writing – review & editing

Roles Funding acquisition, Writing – review & editing

¶ ‡ TOA, DC, MB, JS and CM are contributed equally to this work.

Affiliations Department of Community Health Sciences, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada, Department of Psychiatry, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada

Roles Formal analysis, Funding acquisition, Methodology, Writing – review & editing

Affiliations ANU College of Health and Medicine, Australian National University, Canberra, Australia, Data Analysis in Population Health Hub, National Centre for Epidemiology and Population Health, Canberra, Australia

Affiliations Department of Community Health Sciences, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada, Manitoba Centre for Health Policy, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada

Roles Conceptualization, Funding acquisition, Methodology, Writing – review & editing

Affiliations Department of Community Health Sciences, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada, Department of Psychiatry, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada, Department of Psychology, University of Manitoba, Winnipeg, Manitoba, Canada

Roles Conceptualization, Writing – review & editing

Affiliation Assembly of Manitoba Chiefs, Winnipeg, Manitoba, Canada

Roles Conceptualization, Formal analysis, Funding acquisition, Methodology, Supervision, Writing – original draft, Writing – review & editing

Affiliations Department of Surgery, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada, Department of Psychiatry, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada, Firefighters Burn Unit, Health Sciences Centre, Winnipeg, Manitoba, Canada

* E-mail: [email protected]

Affiliations Department of Surgery, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada, Manitoba Centre for Health Policy, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada

• Hunter Goodon, 
• Justin Gawaziuk, 
• Brenda Comaskey, 
• Tracie O. Afifi, 
• Dan Château, 
• Marni Brownell, 
• Jitender Sareen, 
• Cora Morgan, 
• Sarvesh Logsetty, 

• Published: November 27, 2023
• https://doi.org/10.1371/journal.pone.0294734
• Reader Comments

Introduction

Traumatic physical injuries are the number one cause of hospitalization and death among children in Canada. The majority of these injuries are preventable. The burden from injury can be reduced through prevention programs tailored to at-risk groups, however, existing research does not provide a strong explanation of how social factors influence a child’s risk of injury. We propose a theoretical framework to better understand social factors and injury in children and will examine the association between these social factors and physical traumatic injury in children using large population-wide data.

Methods and analysis

We will examine data from 11,000 children hospitalized for traumatic physical injury and 55,000 matched uninjured children by linking longitudinal administrative and clinical data contained at the Manitoba Centre for Health Policy. We will examine 14 social determinants of child health measures from our theoretical framework, including receipt of income assistance, rural/urban status, socioeconomic status, children in care, child mental disorder, and parental factors (involvement with criminal justice system, education, social housing, immigration status, high residential mobility, mother’s age at first birth, maternal Axis I mental disorder, maternal Axis II mental disorder and maternal physical disorder) to identify groups and periods of time when children are at greatest risk for traumatic physical injury. A conditional multivariable logistic regression model will be calculated (including all social determinant measures) to determine odds ratios and adjusted odds ratios (95% confidence interval) for cases (injured) and controls (non-injured).

Ethics and dissemination

Health Information Privacy Committee (HIPC No. 2017/2018-75) and local ethics approval (H2018-123) were obtained. Once social measures have been identified through statistical modelling, we will determine how they fit into a Haddon matrix to identify appropriate areas for intervention. Knowing these risk factors will guide decision-makers and health policy.

Citation: Goodon H, Gawaziuk J, Comaskey B, Afifi TO, Château D, Brownell M, et al. (2023) Investigating social determinants of child health and their implications in reducing pediatric traumatic injury: A framework and 17-year retrospective case-control study protocol. PLoS ONE 18(11): e0294734. https://doi.org/10.1371/journal.pone.0294734

Editor: Alvan Ukachukwu, Duke University Medical Center: Duke University Hospital, UNITED STATES

Received: April 26, 2023; Accepted: October 31, 2023; Published: November 27, 2023

Copyright: © 2023 Goodon et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: No datasets were analyzed for the current protocol. Upon study completion, data cannot be shared publicly due to privacy and ethics restrictions for administrative data held at MCHP ( https://umanitoba.ca/manitoba-centre-for-health-policy/data-repository ).

Funding: RS received funding from the Canadian Institutes of Health Research Fall 2020 Project Grant #RN441245 – 452811 ( https://cihr-irsc.gc.ca/e ). The funder did not and will not have a role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

Traumatic physical injuries are the primary cause of childhood mortality and one of the leading causes of hospitalization in children [ 1 ]. In Canada, over 16,000 children are hospitalized every year for injuries [ 2 ]. Injuries have lasting effects on a child’s mental and physical health and social outcomes [ 3 , 4 ]. Over 90% of unintentional childhood injuries are preventable [ 2 ] and prevention programs fuelled by evidence are needed. The success and cost effectiveness of prevention programs can be improved by tailoring programs to specific targeted needs [ 5 ]. We propose a protocol to examine social determinants of children’s health (SDoCH) and identify targets for the development of child traumatic injury prevention programs. SDoCH are a broad category of social and economic factors that influence a child’s health [ 6 ] and typically include factors related to the child’s environment including housing, parental health and those that reflect social support for a child’s development (e.g., community resources and services). While recognized as measures of inequity and important influences on the life cycle of a child, [ 7 , 8 ] SDoCH have been less utilized in the development of injury prevention programs [ 9 ]. The Canadian Pediatric Society (CPS) has advocated for a child injury prevention plan that uses a public health approach and includes the social determinants of health associated with injury risk [ 2 ]. However, the CPS also states research is lacking to support this approach due to difficulty understanding mechanisms, causes and risk factors associated with child injury [ 2 ]. We will address these limitations by presenting a SDoCH theoretical framework and conducting a novel whole-population study linking clinical and administrative data to measure which SDoCH are associated with child traumatic physical injury. This work will inform the development of child injury prevention programs targeting individuals and times of greatest vulnerability.

We will use whole-population administrative data from one Canadian province linked with clinical data from the provincial pediatric trauma registry to evaluate the effects of a broad range of SDoCH on traumatic injury risk in children. To achieve this goal, we will compare 14 measures of SDoCH in children hospitalized for traumatic injury with a matched uninjured control group from the general population. The injured children will be identified over a span of 17 years (2002–2019). Our hypothesis is that odds of injury will be greater for children with adverse SDoCH compared to children without these SDoCH. This proposal expands this field of research by: using linked clinical and whole-population administrative data; building on a theoretical framework that includes a biopsychosocial model of injury; [ 4 ] and development of a Haddon matrix of injury prevention [ 10 ] to enact clinical and policy change. Using linked data we can directly address gaps in the literature by examining whole-population pediatric injury data in a truly novel way, producing robust high-quality information. This information has important implications for children and families through informing decision-making and health policy for children at greatest risk for injury. This approach will help us to: 1) understand the association between 14 SDoCH and pediatric traumatic injury; and 2) identify specific entry points for prevention strategies to optimize uptake and efficiency.

This protocol is an evolution of our previous research in SDoCH and childhood burn injury. A study by our team looked at the role of 13 measures of SDoCH among pediatric burn survivors and found that there were marked differences between children that did and did not experience a burn injury. Specifically, children from low-income households, children in care (i.e., children involved in the child protection system), children from a family that received social assistance and children born to teen mothers were at greater risk of burn injury [ 10 ]. Findings from this work are being used to develop burn prevention education and resources for young mothers and other vulnerable groups. This work identified an additional factor that contributed to injury risk: physical disorder of the child’s mother. Other research has found that having a parent with physical disorders and hospitalizations may impact a child’s behaviour [ 11 ] and decrease the capacity for parents to supervise children. Research using these extensive measures of SDoCH has not been conducted on children with traumatic injury and we will fill this important knowledge and care gap using a large longitudinal whole-population sample.

Theoretical framework

Our theoretical framework has unique strengths which will help us clarify the relationship between childhood traumatic injury and multifaceted measures of SDoCH in one of the largest longitudinal pediatric trauma populations studied to date. The proposed framework and research protocol builds on theoretical frameworks previously utilized by our team: a) Biopsychosocial framework specific to pediatric injury ( S1 Table ); and b) Haddon matrix for injury prevention ( S2 Table ). The biopsychosocial model allows us to create a conceptual framework of the various SDoCH. While identifying which SDoCH place children at greatest risk of traumatic injury is essential, identifying unique intervention points for prevention using the Haddon matrix is what extends the novelty of the protocol. The Haddon matrix is based on the premise that injuries result from harmful interactions between the individual, the agent, the physical environment and the socioeconomic environment [ 12 ]. ( S2 Table ). The Haddon matrix is a validated model used to identify sources and time periods of preventable injuries and potential intervention points [ 12 ]. Combined with the biopsychosocial model, the Haddon matrix will provide a unique perspective on SDoCH and their role in not only child traumatic injury risk but injury prevention and health promotion. The Haddon matrix can be applied to determine how human, physical environmental and socio-economic environmental factors fit into the ‘pre-injury,’ ‘injury’ and ‘post-injury’ time periods. Interventions will then be conceptualized to reflect the complex interaction between factors focusing on ‘pre-injury’ and ‘injury’ time periods. We will use this approach to identify intervention points for children who have experienced traumatic injury [ 13 ]. This theoretical framework is an expansion of previous work on children who experienced burn injury ( S2 Table ).

Research aims and hypothesis

We aim to evaluate associations between a broad range of SDoCH and physical traumatic injury risk in children. Our study objective is to compare 14 SDoCH in children hospitalized with physical traumatic injury with a matched control group (without prior hospitalization for a traumatic injury) from the general population in Manitoba. We hypothesize that odds of injury will be greater for children with adverse SDoCH compared to children without adverse SDoCH.

This study will take place in Manitoba, the central province in Canada, with a population of 1,390,249; 312,164 under the age of 18 [ 14 ]. The Manitoba Centre for Health Policy (MCHP) is a research centre within the University of Manitoba that houses a repository of de-identified provincial, universally-insured health services data and social services data, including social determinants of health, that enables linkage between clinical and social data [ 15 ]. We propose a 17-year case-control study matching cases (injured children) with controls (uninjured children from the general population) to examine SDoCH using anonymized administrative data housed at the MCHP repository linked with the clinical data in the HSC Winnipeg Children’s Hospital clinical trauma registry (“Pediatric Trauma Registry”). The total sample size for this study is approximately 66,000. We will calculate odds ratios (OR) and adjusted odds ratios (AOR) for the odds of injury associated with each SDoCH. We will use the identified factors to develop a Haddon matrix to guide creation of injury prevention programs.

Definitions

Children (≤17 years of age) hospitalized with injuries identified from the Pediatric Trauma Registry over a seventeen-year period (2002–2019). The registry contains data from approximately 11,000 hospitalized children. The date of injury will be identified as the ‘index date.’

The cases (injured) will be matched 1:5 with controls from the general population (uninjured prior to the index date) based on sex, geographical region and age on the index date (55,000 matches).

Exposure risk factors (independent variables).

14 SDoCH measurable (at various time points/periods) using administrative data: Receipt of income assistance, rural/urban status, socioeconomic status, children in care, child mental disorder and parental factors (involvement with criminal justice system, education, social housing, immigration status, high residential mobility, mother’s age at first birth, Axis I mental disorder diagnosis, Axis II mental disorder diagnosis, maternal physical disorder).

Outcome (dependent variable).

Child hospitalized with an injury. We will look at the following subgroups: a) Major injury (Injury Severity Score (ISS) ≥12); b) Minor injury (ISS<12); and c) intentional (i.e., assault) and unintentional (i.e., accidental, non-assault) injuries. The standard measure of extent of injury is the Injury Severity Score (ISS). Based on identifying injuries in one of six body parts or regions, the ISS has been shown to correlate with mortality and morbidity [ 16 ]. In Canada, the definition of major trauma is an ISS≥12.

Data sources

Pediatric trauma registry..

This study will utilize linked data from the Pediatric Trauma Registry. All children in the province of Manitoba with a significant injury are treated at this hospital. Information recorded in this registry includes date of injury, demographic factors such as age and sex and injury related factors (etiology of the injury, e.g., motor vehicle collision; context of injury, e.g., recreational; admission to intensive care unit).

Manitoba Centre for Health Policy (MCHP).

MCHP is a research data centre within the University of Manitoba that houses a world-renowned repository of de-identified provincial health service data supplemented with a variety of other social services and public use datasets for the purposes of health-related research (over 90+ datasets) [ 15 ]. This rich, whole-population repository holds data over a 50-year period including health care usage (hospitalizations, emergency department use, ambulatory care and specialist physician visits, prescription drug utilization) and data on the following: vital statistics (birth and death records), Canada census, immigration, education, justice, use of income assistance and other social services including child protection and social housing.

Data linkage and matching.

A password-protected copy of the Trauma Registry will be sent to the provincial ministry of health where the data will be anonymized (i.e., any identifying information removed) and a scrambled Personal Health Identification Number (sPHIN) attached. This anonymized data will then be sent to MCHP to be linked with the datasets using this sPHIN. Identifying information of participants will not be accessible to the authors prior to, during or after data collection and analysis. The administrative datasets for this study ( S3 Table ) include:

Pediatric Trauma Registry; Manitoba Health Registry; Hospital Separations Abstracts; Medical Claims (physician billings); Vital Statistics Mortality; Prosecutions Information Management System (PIMS); Employment / Income Assistance (SAMIN); Child and Family Services—Applications and Intake; Social Housing Tenant Management System (TMSI); and Enrollment, Marks, and Assessments (STS/ICAB). Immigration status is determined as previously described by Katz et al. [ 8 ] To the best of our knowledge, the linkage of the pediatric clinical injury registry with a whole-population data repository of this magnitude will be unique in Canada and the world.

Social determinants of health to be evaluated

The SDoCH for this study are based on previous work by our research team, [ 10 , 17 ] MCHP examinations of social determinants of health [ 18 – 20 ] and the literature. Based on work conducted by MCHP, there are 13 determinants that are measurable using the administrative datasets available. Our group has used these determinants to examine pediatric burn injury [ 10 , 17 ]. Based on this previous work, we have added one additional factor to provide further investigation into the child’s environment: mother with a physical disorder. In Manitoba, almost 100% of children can be linked with their mother’s PHIN at birth; linkages to fathers are considerably lower, [ 15 ] making mothers’ health the best available marker for parents. Similarly, other parental measures (such as involvement in the justice system) may also reflect information pertaining to the child’s mother. SDoCH to be examined for this study are:

• Low-income household . A child from a family living in a low income neighbourhood (lowest-income quintile), based on Canada census data.
• Rural status : A child from a family residing in a postal code outside of a city with a population of >10,000 people, based on residential postal code at index date.
• Child from a family that has received income assistance : A child from a family that has received financial income assistance from the Employment and Income Assistance Program (EIA) in Manitoba.
• Child with parent(s) involved in the justice system (as a victim , witness , or accused) : A child with one or both parents involved in the justice system, based on data acquired via Prosecution Information and Scheduling Management (PRISM) developed by Manitoba Justice Prosecution Service.
• Child of parent(s) who did not graduate high school : Child from a family where one or both parents did not complete high school, based on graduation status data from Manitoba Education.
• Child with parent(s) in social housing : A child from a family who has lived in social housing managed by Manitoba Housing and Community Development.
• Child of parent(s) who immigrated : A child of a parent from a native country that is not Canada, based on census data [ 8 ].
• Child from a family with high residential mobility : A child from a family that moved residences three or more times within 10 person-years.
• Child of a teen mother : A child of a mother who first gave birth at age 19 years or younger.
• Child with any mental health disorder : The presence of an Axis I mental disorder measured using ICD codes (anxiety, depression, substance use disorder; See S4 Table ). Both Axis I and Axis II disorders will be combined into one variable as we have observed that the prevalence of either of these diagnoses in children is relatively rare.
• Child of a mother with a major mental health disorder : A child born to a mother with an Axis II mental disorder, based on ICD-9 diagnosis codes (See S4 Table ). “Any Axis II Disorder” will combine Axis II diagnoses codes into one variable.
• Child of a mother with an Axis I mental disorder : The presence of an Axis I mental disorder in the mother, measured using ICD codes (anxiety, depression, substance use disorder; See S4 Table ). “Any Axis I Disorder” combines anxiety, depression and substance use into one variable.
• Child of a mother with a physical disorder : Disorders of interest are based on previous work and will include: cardiovascular disease, cancer, chronic obstructive pulmonary disease, hypertension and diabetes [ 17 ]. (See S4 Table for diagnostic codes.) One or more hospitalizations pre-index date and/or one or more outpatient visits (physician billing) are considered a mental disorder or physical disorder.
• Child in care : A child removed from family of origin and placed in the care of another adult due to concerns related to care, occurring at any time prior to the index date. This measure may be hypothesis-generating for future research in this area.

Analytic strategy

SAS will be used for all analyses (Version 9.4, SAS Institute, Cary, NC, USA).

Sample size and minimum detectable effect size

We have a fixed number of approximately 11,000 cases and an additional 55,000 matches for a total sample size of 66,000. We used prevalence estimates and identified effect sizes observed in previous work on SDoCH in burn injury [ 10 ] to calculate minimum detectable effect sizes ( S5 Table ). We have sufficient power to detect AORs ranging from 1.1 to 2.1, depending on the prevalence of the specific SDoCH. S5 Table describes the minimum detectable odds ratios given the anticipated injury population with examples of low and high prevalence SDoCH.

Stages of analysis

Stage 1: descriptive statistics..

Descriptive statistics for demographic variables (age, sex, geographic location) will be calculated and contingency tables will be generated. Descriptive statistics for injury-related factors (number and type of operative procedures, etiology of the injury, context of injury, intubation at arrival, admission to intensive care unit and ventilator days) will be calculated including measures of central tendency and standard deviations for the injured cohort. Demographics will be compared between cases and the matched controls ensuring similarities between cohorts.

Stage 2: Comparison of odds between cohorts.

Conditional univariate analyses will be performed on individual SDoCH measures as covariates using case/control as the binary response. A correlation matrix will be calculated to examine overlap between SDoCH categories and guide model development. A conditional multivariable logistic regression model will be calculated including all SDoCH measures to determine odds ratios and adjusted odds ratios using a 95% confidence interval (CI) for cases (injured) and controls (non-injured). A time offset will be incorporated into the model to account for variable pre-injury exposure to the SDoCH. We will stratify analyses by injury severity for subgroup analysis and will create interaction terms and correlation matrices to understand the correlation between sex and SDoCH measures and how this interaction impacts injury risk. The development of these correlation matrices will identify factors that have a stronger association with one sex, informing future research into sex and injury. Given the multiple comparisons (14 SDoCH) we will define statistical significance at p≤.005.

Stage 3: Application of a Haddon matrix.

Once SDoCH have been identified through statistical modelling, we will determine how these factors fit into the Haddon matrix categories (human, physical environment and socio-economic environment) across the two time points of interest (‘pre-injury’ and ‘injury’). Haddon matrix values (1–9) will be assigned according to interactions in the matrix (factor x time point), and interventions will be conceptualized to reflect each interaction.

Study approvals from the Health Information Privacy Committee (HIPC #2017/2018–75), local ethics (H2018-123) and data providers were obtained. As the study will use anonymized whole population administrative data, consent from individual participants is not required. We have created a logic model of our integrated knowledge translation (KT) plan ( S6 Table ) recognizing that knowledge dissemination will be developed according to findings and intervention points identified by the Haddon matrix and in collaboration with our team. This plan has involved knowledge users (clinicians and collaborators) from the creation of the proposal and will continue to the dissemination of findings. Through this research we will identify key interest groups to engage in creating future prevention programs.

Supporting information

S1 table. conceptual biopsychosocial framework specific to pediatric injury, social determinants of child health (sdoch) and development of subsequent poor health..

https://doi.org/10.1371/journal.pone.0294734.s001

S2 Table. Haddon matrix of injury prevention.

https://doi.org/10.1371/journal.pone.0294734.s002

S3 Table. Administrative datasets to be used in the study.

https://doi.org/10.1371/journal.pone.0294734.s003

S4 Table. ICD-9-CM and ICD-10-CA codes.

https://doi.org/10.1371/journal.pone.0294734.s004

S5 Table. Minimum detectable effect size (odds ratios).

https://doi.org/10.1371/journal.pone.0294734.s005

S6 Table. Logic model of research project and integrated knowledge translation plan.

https://doi.org/10.1371/journal.pone.0294734.s006

S1 File. References for appendices.

https://doi.org/10.1371/journal.pone.0294734.s007

Acknowledgments

The authors acknowledge the Manitoba Centre for Health Policy for use of data contained in the Manitoba Population Research Data Repository under project #2018–022 (HIPC# 2017/2018-75). Data used in this study are from the Manitoba Population Research Data Repository housed at the Manitoba Centre for Health Policy, University of Manitoba and were derived from data provided by Manitoba Health, Manitoba Justice, Education and Early Childhood Care, Department of Families, and Immigration, Refugees and Citizenship Canada (using Research Extracts which include the Permanent Resident Database provided by IRCC). The results and conclusions are those of the authors and no official endorsement by the Manitoba Centre for Health Policy, Manitoba Health or other data providers is intended or should be inferred.

• 1. Peden M, Oyegbite K, Ozanne-Smith J, Hyder AA, Branche C, Rahman AKMF, et al. Editors. World report on child injury prevention. Chapter 1: Child injuries in context. Geneva: World Health Organization; 2008. Available from: https://www.ncbi.nlm.nih.gov/books/NBK310643/
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Guthrie S, Bienkowska-Gibbs T, Manville C, et al. The impact of the National Institute for Health Research Health Technology Assessment programme, 2003–13: a multimethod evaluation. Southampton (UK): NIHR Journals Library; 2015 Aug. (Health Technology Assessment, No. 19.67.)

The impact of the National Institute for Health Research Health Technology Assessment programme, 2003–13: a multimethod evaluation.

Appendix 3 case study interview protocol.

• A. Introduction

RAND Europe has been commissioned by the HTA programme to assess its impact over the last 10 years.

RAND Europe is a non-profit policy research organisation, with an interest in research policy.

As part of this project, we are building a series of case studies around research funded by the HTA programme to identify the nature and range of impacts the programme has had, and how they came about. In a separate stream of work we are also looking across the programme as a whole for the impacts it has had using interviews, bibliometrics and a survey.

Our previous work in this area includes: payback studies of research impact on Mental Health research, Cardiovascular research, Arthritis research and Social science research. We have also carried out two studies for government and charitable research funders estimating the economic benefit of investing in medical research.

Drawing on a range of sources, we identified a long list of potential case studies and selected a stratified sample which included your study into XXXX published in the HTA journal article XXXX. We’d like to talk to you about how that research came about how it fitted into the other research you were doing at the time and how it developed.

For this project, we are looking at both how the findings of the research were developed and translated; and also, how the research undertaken developed the careers of the researchers involved.

We would like to record this interview. You will be given the opportunity to review the draft case study before it is published and request that any direct quotations used are removed or anonymised.

You should also emphasize that not all the questions will be relevant to their research project, and indeed we wouldn’t expect them all to be.

You shouldn’t stick to the protocol as written – it just provides guidance of the areas you should aim to cover. During your desk research you will have identified additional questions that you will want to ask and it’s probably best to add these to the protocol.

• B. Introductory questions

To begin, talk briefly about their current work and how it relates to what they were doing at the time.

Can you tell us a bit about what you were doing at the time?

Where you were in your career?

Can you give us some background to this project?

Why do you think this project was seen as important?

• C. Stage 0: Opportunity identification/research needs assessment

Was this project commissioned or was it a response mode grant?

• If commissioned, what was the source of the idea for the research?
• If response mode, what was the original impetus for the work? (Solely scientific curiosity? The desire to fill certain gaps in knowledge? Targeting of a particular disease state? Your own clinical experience?)

Was there a clear intended impact on policy or practice from the outset?

What other ideas were you pursuing at the time, how did they relate to this work?

Who influenced your decision to work in this area?

Was it a continuation of previous work?

How far was your identification of the research topic influenced by:

• Research you had done before? Funded by whom?
• The research of others? If so how did you hear about this research?
• For primary research, an existing systematic review?

How much interaction was involved in determining your choice of research topic?

• With representatives of patient or practitioner groups?
• With funders?
• With peers internationally in a specific research community?

Did institutional conditions such as lab space, equipment, or availability of researchers affect the research proposal?

• D. Stage 1: Inputs to research and project specification and selection

How much funding did you receive from the HTA?

Were there other sources of funding which supported this work?

• What were the different forms of support and why was each important?
• Was there soft or core funding (e.g. funding the needs to be applied for vs. guaranteed funding)?

Did you make any unsuccessful applications for funding? Did you make any resubmissions?

Did any of the peer review or applications processes affect the design or direction of the work?

Did you have to compete for funding?

Did you consult with patients, the public or practitioners in developing the research design? What role did their input play?

What was the institutional setting (hospital, university, research institute) for the research?

Who were the main researchers involved in the project?

What was their level of research experience and seniority at that time?

Had they previously worked in this research area?

For primary research: did any existing systematic review play a role in your research design (e.g. in determining necessary sample sizes)?

Which of the following inputs were important?

• Knowledge/expertise
• Samples/study recruits
• Consumables
• Collaborators
• Reputation.
• E. Stage 2: Processes

Did the methods proposed prove to be appropriate? Which avenues of research were successful and which weren’t?

Was there any interaction with potential users of the research during the research processes?

How much freedom did you or the research group have to pursue different lines of enquiry/deviate from the original proposal? How important was this flexibility in achieving the final results?

Did you publish the research protocol at the start of the study?

Did the research require new techniques/new expertise/new approaches to the subject?

How would you describe your role in the research process?

What was the role of collaborators in the research process (both academic and industrial)?

Who else was working in the area?

What interaction did you have with HTA programme staff during the research process? How useful was this interaction?

• F. Stage 3: Primary outputs

Which publications do you think were most important from this research and why?

Did this work have any impact on the agenda for your subsequent research?

Did this research make any impact on the career of any of the research team? For example: contribute to research training in terms of research degrees or the gaining of additional skills

• enable them to establish themselves in the field?
• help the lead researcher to build a team of researchers?

Are you aware of any other researchers who have built on this work or used the methods you developed? What is the role of collaborators in this?

Did the research spawn a new area of investigation or make a major impact on the approach used in subsequent research?

If the research was clinical, were any basic researchers also involved? If so did this influence their attitude to clinical research?

Were any health practitioners involved in assisting with the research, and if so did it have any impact on their attitude towards implementing research findings in general?

For primary research: has the research been included in any subsequent systematic reviews or meta-analyses?

For evidence synthesis: has any primary research been conducted based on the findings of your work?

Have you had any impact outside the field of research you are working in?

Were any findings of the research not published (e.g. dead ends, negative findings)?

• G. Interface B: Dissemination

Apart from publications, what attempt did you make to disseminate the findings

• to academic audiences?
• to wider audiences? Did you work with funders or stakeholders to do this?

Did you use specially designed dissemination approaches to particular audiences, for example policy briefs for policy-makers? What were the most effective mechanisms for this?

What was the role of your networks in dissemination?

Did you receive support from funders/employers for dissemination? What form did this take?

• H. Stage 4: Secondary outputs

Has the research been cited directly in any clinical guideline, audit criteria or similar document from a professional body or public policy-making body at national or local level?

Do you know how far the research directly influenced the formulation of any policy, or the realisation that a policy was needed?

Has any subsequent research by you or others that built on this project been cited in any clinical guideline, audit criteria or similar document from a professional body or public policy-making body at national or local level? Do you think this might happen in future?

Did the research from your project lead to any patents/licences? Was it taken up by industry? Has it contributed to any commercial products?

If the research has made some impact, what are the key reasons for this? If it has failed to have an impact what are the reasons for this?

What barriers were there to the research having an impact/being translated?

What factors facilitated the research having an impact/being translated?

Has your research had an impact on teaching for clinicians?

Has any advisory role to government, hospitals, industry led to an impact from your research? How did this come about?

• I. Stage 5: Applications

Have the findings from the research influenced practitioners directly through them reading the articles or hearing a presentation about the research?

What were the impacts on practice through clinical guidelines or policies based either specifically on the research or on other research that built on your research?

Can you comment on the extent of implementation? How widely have those policies or guidelines been taken up?

Have the findings been disseminated through other routes such as networks or existing relationships with practitioners?

Has any impact been local, regional, national or international?

If the research has been taken up by industry, do you know what level of sales has been achieved by any product to which it contributed?

Do you expect any greater take-up of the findings in the future? Where and how?

Has there been an impact on practice through your own clinical work (if you have any)? What has been the knock-on effect of that on other clinicians?

• J. Stage 6: Public engagement

Depending on answers to previous questions about involvement of the public in shaping the research agenda, ask how far there has been any interaction with patients, patient groups or the wider public about the findings and their implication. Has this led to any improvement in the way patients manage their own care or interact with therapy? Or had any impact on public attitudes to medical research? Please describe these.

Did engagement with the public/patient groups lead to changes in the researchers’ perceptions of these groups? Please describe.

• K. Stage 7: Final outcomes

If the research has made impact on policy or practice, or on the behaviour of the public, is there any way of assessing the benefits in terms of: patient health gain? Qualitative improvements in the way the service is delivered that increase patient and/or practitioner satisfaction? Cost savings?

If it is possible to assess the potential benefit for one patient, approximately how many patients might be able to benefit from the improved therapy or organisation of the service?

If the improved therapy based on the research has resulted in a health gain, will this also result in fewer days lost from work/decreased benefits payments/decreased visits to secondary health care?

If the research has resulted in commercial development is anything known about the amount of employment generated, the level of import substitution, or the revenue generated for the company by the product?

• L. Other general questions

Who else should we speak to about your research?

Are there other questions we should have asked or things that you want to talk about?

Are you happy for us to contact you to follow up on details arising from the case study research?

Included under terms of UK Non-commercial Government License .

• Cite this Page Guthrie S, Bienkowska-Gibbs T, Manville C, et al. The impact of the National Institute for Health Research Health Technology Assessment programme, 2003–13: a multimethod evaluation. Southampton (UK): NIHR Journals Library; 2015 Aug. (Health Technology Assessment, No. 19.67.) Appendix 3, Case study interview protocol.
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The Case Study Protocol

A case study protocol has only one thing in common with a survey question­naire: Both are directed at a single data point—either a single case (even if the case is part of a larger, multiple-case study) or a single respondent.

Beyond this similarity are major differences. The protocol is more than a questionnaire or instrument. First, the protocol contains the instrument but also contains the procedures and general rales to be followed in using the pro­tocol. Second, the protocol is directed at an entirely different party than that of a survey questionnaire, explained below. Third, having a case study protocol is desirable under all circumstances, but it is essential if you are doing a mul­tiple-case study.

The protocol is a major way of increasing the reliability of case study research and is intended to guide the investigator in carrying out the data col­lection from a single case (again, even if the single case is one of several in a multiple-case study). Figure 3.2 gives a table of contents from an illustrative protocol, which was used in a study of innovative law enforcement practices supported by federal funds. The practices had been defined earlier through a careful screening process (see later discussion in this chapter for more detail on “screening case study nominations”). Furthermore, because data were to be collected from 18 such cases as part of a multiple-case study, the information about any given case could not be collected in great depth, and thus the number of the case study questions was minimal.

As a general matter, a case study protocol should have the following sections:

• an overview of the case study project (project objectives and auspices, case study issues, and relevant readings about the topic being investigated),
• field procedures (presentation of credentials, access to the case study “sites,” language pertaining to the protection of human subjects, sources of data, and procedural reminders),
• case study questions (the specific questions that the case study investigator must keep in mind in collecting data, “table shells” for specific arrays of data, and the potential sources of information for answering each question—see Figure 3.3 for an example), and
• a guide for the case study report (outline, format for the data, use and presenta­tion of other documentation, and bibliographical information).

A quick glance at these topics will indicate why the protocol is so important. First, it keeps you targeted on the topic of the case study. Second, preparing the protocol forces you to anticipate several problems, including the way that the case study reports are to be completed. This means, for instance, that you will have to identify the audience for your case study report even before you have conducted your case study. Such forethought will help to avoid mismatches in the long run.

The table of contents of the illustrative protocol in Figure 3.2 reveals another important feature of the case study report: In this instance, the desired report starts by calling for a description of the innovative practice being studied (see item Cl in Figure 3.2)—and only later covers the agency context and history pertaining to the practice (see item C4). This choice reflects the fact that most investigators write too extensively on history and background conditions. While these are important, the description of the subject of the study—the innovative practice—needs more attention.

Each section of the protocol is discussed next.

1. Overview of the Case Study Project

The overview should cover the background information about the project, the substantive issues being investigated, and the relevant readings about the issues.

As for background information, every project has its own context and perspective. Some projects, for instance, are funded by government agencies having a general mission and clientele that need to be remembered in con­ducting the research. Other projects have broader theoretical concerns or are offshoots, of earlier research studies. Whatever the situation, this type of back­ground information, in summary form, belongs in the overview section.

A procedural element of this background section is a statement about the project which you can present to anyone who may want to know about the pro­ject, its purpose, and the people involved in conducting and sponsoring the project. This statement can even be accompanied by a letter of introduction, to be sent to all major interviewees and organizations that may be the subject of study. (See Figure 3.4 for an illustrative letter.) The bulk of the overview, how­ever, should be devoted to the substantive issues being investigated. This may include the rationale for selecting the case(s), the propositions or hypotheses being examined, and the broader theoretical or policy relevance of the inquiry. For all of these topics, relevant readings should be cited, and the essential read­ing materials should be made available to everyone on the case study team.

A good overview will communicate to the informed reader (that is, some­one familiar with the general topic of inquiry) the case study’s purpose and set­ting. Some of the materials (such as a summary describing the project) may be needed for other purposes anyway, so that writing the overview should be seen as a doubly worthwhile activity. In the same vein, a well-conceived overview even may later form the basis for the background and introduction to the final case study report.

2. Field Procedures

Chapter 1 has previously defined case studies as studies of events within their real-life context. This has important implications for defining and design­ing the case study, which have been discussed in Chapters 1 and 2.

For data collection, however, this characteristic of case studies also raises an important issue, for which properly designed field procedures are essential. You will be collecting data from people and institutions in their everyday situations, not within the controlled confines of a laboratory, the sanctity of a library, or the structured limitations of a survey questionnaire. In a case study, you must there­fore learn to integrate real-world events with the needs of the data collection plan. In this sense, you do not have the control over the data collection environment as others might have in using the other research methods discussed in Chapter 1.

Note that in a laboratory experiment, human “subjects” are solicited to enter into the laboratory—an environment controlled nearly entirely by the research investigator. The subject, within ethical and physical constraints, must follow the investigator’s instructions, which carefully prescribe the desired behavior. Similarly, the human “respondent” to a survey questionnaire cannot deviate from the agenda set by the questions. Therefore, the respondent’s behavior also is con­strained by the ground rules of the investigator. Naturally, the subject or respon­dent who does not wish to follow the prescribed behaviors may freely drop out of the experiment or survey. Finally, in the historical archive, pertinent documents may not always be available, but the investigator can inspect what exists at his or her own pace and at a time convenient to her or his schedule. In all three situa­tions, the research investigator closely controls the formal data collection activity.

Doing case studies involves an entirely different situation. For interviewing key persons, you must cater to the interviewee’s schedule and availability, not your own. The nature of the interview is much more open-ended, and an interviewee may not necessarily cooperate fully in sticking to your line of questions. Similarly, in making observations of real-life activities, you are intruding into the world of the subject being studied rather than the reverse; under these conditions, you are the one who may have to make special arrangements, to be able to act as an observer (or even as a participant- observer). As a result, your behavior—and not that of the subject or respon­dent—is the one likely to be constrained.

This contrasting process of doing data collection leads to the need to have explicit and well-planned field procedures encompassing guidelines for “cop­ing” behaviors. Imagine, for instance, sending a youngster to camp; because you do not know what to expect, the best preparation is to have the resources to be prepared. Case study field procedures should be the same way.

With the preceding orientation in mind, the field procedures of the protocol need to emphasize the major tasks in collecting data, including

• gaining access to key organizations or interviewees;
• having sufficient resources while in the field—including a personal computer, writing instruments, paper, paper clips, and a preestablished, quiet place to write notes privately;
• developing a procedure for calling for assistance and guidance, if needed, from other case study investigators or colleagues;
• making a clear schedule of the data collection activities that are expected to be completed within specified periods of time; and
• providing for unanticipated events, including changes in the availability of interview­ees as well as changes in the mood and motivation of the case study investigator.

These are the types of topics that can be included in the field procedures sec­tion of the protocol. Depending upon the type of study being done, the specific procedures will vary.

The more operational these procedures are, the better. To take but one minor issue as an example, case study data collection frequently results in the accu­mulation of numerous documents at the field site. The burden of carrying such bulky documents can be reduced by two procedures. First, the case study team may have had the foresight to bring large, prelabeled envelopes, to mail the documents back to the office rather than carry them. Second, field time may have been set aside for perusing the documents and then going to a local copier facility and copying only the few relevant pages of each document—and then returning the original documents to the informants at the field site. These and other operational details can enhance the overall quality and efficiency of case study data collection.

A final part of this portion of the protocol should carefully describe the procedures for protecting human subjects. First, the protocol should repeat the rationale for the IRB-approved field procedures. Then, the protocol should include the “scripted” words or instructions for the team to use in obtaining informed consent or otherwise informing case study interviewees and other participants of the risks and conditions associated with the research.

3. Case Study Questions

The heart of the protocol is a set of substantive questions reflecting your actual line of inquiry. Some people may consider this part of the protocol to be the case study “instrument.” However, two characteristics distinguish case study questions from those in a survey instrument. (Refer back to Figure 3.3 for an illustrative question from a study of a school program; the complete protocol included dozens of such questions.)

General orientation of questions. First, the questions are posed to you, the investigator, not to an interviewee. In this sense, the protocol is directed at an entirely different party than a survey instrument. The protocol’s questions, in essence, are your reminders regarding the information that needs to be col­lected, and why. In some instances, the specific questions also may serve as prompts in asking questions during a case study interview. However, the main purpose of the protocol’s questions is to keep the investigator on track as data collection proceeds.

Each question should be accompanied by a list of likely sources of evidence. Such sources may include the names of individual interviewees, documents, or observations. This crosswalk between the questions of interest and the likely sources of evidence is extremely helpful in collecting case study data. Before arriving on the case study scene, for instance, a case study investigator can quickly review the major questions that the data collection should cover.

(Again, these questions form the structure of the inquiry and are not intended as the literal questions to be asked of any given interviewee.)

Levels of questions. Second, the questions in the case study protocol should distinguish clearly among different types or levels of questions. The poten­tially relevant questions can, remarkably, occur at any of five levels:

Level 1: questions asked of specific interviewees;

Level 2: questions asked of the individual case (these are the questions in the case study protocol to be answered by the investigator during a single case, even when the single case is part of a larger, multiple-case study);

Level 3: questions asked of the pattern of findings across multiple cases;

Level 4: questions asked of an entire study—for example, calling on information beyond the case study evidence and including other literature or published data that may have been reviewed; and

Level 5: normative questions about policy recommendations and conclusions, going beyond the narrow scope of the study.

Of these five levels, you should concentrate heavily on Level 2 for the case study protocol.

The difference between Level 1 and Level 2 questions is highly significant. The two types of questions are most commonly confused because investigators think that their questions of inquiry (Level 2) are synonymous with the spe­cific questions they will ask in the field (Level 1). To disentangle these two levels in your own mind, think again about a detective, especially a wily one. The detective has in mind what the course of events in a crime might have been (Level 2), but the actual questions posed to any witness or suspect (Level 1) do not necessarily betray the detective’s thinking. The verbal line of inquiry is different from the mental line of inquiry, and this is the difference between Level 1 and Level 2 questions. For the case study protocol, explicitly articu­lating the Level 2 questions is therefore of much greater importance than any attempt to identify the Level 1 questions.

In the field, keeping in mind the Level 2 questions while simultaneously articulating Level 1 questions in conversing with an interviewee is not easy. In a like manner, you can lose sight of your Level 2 questions when examin­ing a detailed document that will become part of the case study evidence (the common revelation occurs when you ask yourself, “Why am I reading this document?”). To overcome these problems, successful participation in the earlier seminar training helps. Remember that being a “senior” investigator means maintaining a working knowledge of the entire case study inquiry. The (Level 2) questions in the case study protocol embody this inquiry.

The other levels also should be understood clearly. A cross-case question, for instance (Level 3), may be whether the larger school districts among your cases are more responsive than smaller school districts or whether complex bureaucratic structures make the larger districts more cumbersome and less responsive. However, this Level 3 question should not be part of the protocol for collecting data from the single case, because the single case only can address the responsiveness of a single school district. The Level 3 question cannot be addressed until the data from all the single cases (in a multiple-case study) are examined. Thus, only the multiple-case analysis can cover Level 3 questions. Similarly, the questions at Levels 4 and 5 also go well beyond any individual case study, and you should note this limitation if you include such questions in the case study protocol. Remember: The protocol is for the data collection from a single case (even when part of a multiple-case study) and is not intended to serve the entire project.

Undesired confusion between unit of data collection and unit of analysis. Related to the distinction between Level 1 and Level 2 questions, a more sub­tle and serious problem can arise in articulating the questions in the case study protocol. The questions should cater to the unit of analysis of the case study, which may be at a different level from the unit of data collection of the case study. Confusion will occur if, under these circumstances, the data collection process leads to an (undesirable) distortion of the unit of analysis.

The common confusion begins because the data collection sources may be individual people (e.g., interviews with individuals), whereas the unit of analy­sis of your case study may be a collective (e.g., the organization to which the individual belongs)—a frequent design when the case study is about an orga­nization, community, or social group. Even though your data collection may have to rely heavily on information from individual interviewees, your con­clusions cannot be based entirely on interviews as a source of information (you would then have collected information about individuals’ reports about the organization, not necessarily about organizational events as they actually had occurred). In this example, the protocol questions therefore need to be about the organization, not the individual.

However, the reverse situation also can be true. Your case study may be about an individual, but the sources of information can include archival records (e.g., personnel files or student records) from an organization. In this situation, you also would want to avoid basing your conclusions about the individual from the organizational sources of information only. In this example, the protocol ques­tions therefore need to be about the individual, not the organization.

Figure 3.5 illustrates these two situations, where the unit of analysis for the case study is different from the unit of data collection.

Other data collection devices. The protocol questions also can include empty “table shells” (for more detail, see Miles & Huberman, 1994). These are the outlines of a table, defining precisely the “rows” and “columns” of a data array—but in the absence of having the actual data. In this sense, the table shell indicates the data to be collected, and your job is to collect the data called forth by the table. Such table shells help in several ways. First, the table shells force you to identify exactly what data are being sought. Second, they ensure that parallel information will be collected at different sites, where a multiple- case design is being used. Finally, the table shells aid in understanding what will be done with the data once they have been collected.

4. Guide for the Case Study Report

This element is generally missing in most case study plans. Investigators neglect to think about the outline, format, or audience for the case study report until after the data have been collected. Yet, some planning at this preparatory stage—admittedly out of sequence in the typical conduct of most research— means that a tentative outline can (and should) appear in the case study protocol. (Such planning accounts for the arrow between “prepare” and “share” in the figure at the outset of this chapter.)

Again, one reason for the traditional, linear sequence is related to practices with other research methods. One does not worry about the report from an exper­iment until after the experiment has been completed, because the format of the report and its likely audience already have been dictated by the conventional for­mats of academic journals. Most reports of experiments follow a similar outline: the posing of the research questions and hypotheses; a description of the research design, apparatus, and data collection procedures; the presentation of the data collected; the analysis of the data; and a discussion of findings and conclusions.

Unfortunately, case study reports do not have such a uniformly acceptable outline. Nor, in many instances, do case study reports end up in journals (Feagin et al., 1991, pp. 269-273). For this reason, each investigator must be concerned, throughout the conduct of a case study, with the design of the final case study report. The problem is not easy to deal with.

In addition, the protocol also can indicate the extent of documentation for the case study report. Properly done, the data collection is likely to lead to large amounts of documentary evidence, in the form of published reports, publica­tions, memoranda, and other documents collected about the case. What is to be done with this documentation, for later presentation? In most studies, the docu­ments are filed away and seldom retrieved. Yet, this documentation is an impor­tant part of the “database” for a case study (see Chapter 4) and should not be ignored until after the case study has been completed. One possibility is to have the case study report include an annotated bibliography in which each of the available documents is itemized. The annotations would help a reader (or the investigator, at some later date) to know which documents might be relevant for further inquiry.

In summary, to the extent possible, the basic outline of the case study report should be part of the protocol. This will facilitate the collection of relevant data, in the appropriate format, and will reduce the possibility that a return visit to the case study site will be necessary. At the same time, the existence of such an outline should not imply rigid adherence to a predesigned protocol. In fact, case study plans can change as a result of the initial data collection, and you are encouraged to consider these flexibilities—if used properly and with­out bias—to be an advantage of the case study method.

EXERCISE 3.4 Developing a Case Study Protocol

Select some phenomenon in need of explanation from the everyday life of your university or school (past or present). Illustrative topics might be, for example, why the university or school changed some policy or how it makes decisions about its curriculum requirements. For these illustrative topics (or some topics of your own choosing), design a case study protocol to collect the information needed to make an adequate explanation. What would be your main research questions or propositions? What specific sources of data would you seek (e.g., persons to be interviewed, documents to be sought, and field observations to be made)? Would your protocol be sufficient in guiding you through the entire process of doing your case study?

Source: Yin K Robert (2008), Case Study Research Designs and Methods , SAGE Publications, Inc; 4th edition.

13 Aug 2021

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