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Management Research Review

ISSN : 2040-8269

Article publication date: 4 July 2023

Issue publication date: 11 January 2024

Case study research has been applied across numerous fields and provides an established methodology for exploring and understanding various research contexts. This paper aims to aid in developing methodological rigor by investigating the approaches of establishing validity and reliability.

Design/methodology/approach

Based on a systematic review of relevant literature, this paper catalogs the use of validity and reliability measures within academic publications between 2008 and 2018. The review analyzes case study research across 15 peer-reviewed journals (total of 1,372 articles) and highlights the application of validity and reliability measures.

The evidence of the systematic literature review suggests that validity measures appear well established and widely reported within case study–based research articles. However, measures and test procedures related to research reliability appear underrepresented within analyzed articles.

Originality/value

As shown by the presented results, there is a need for more significant reporting of the procedures used related to research reliability. Toward this, the features of a robust case study protocol are defined and discussed.

• Case study research
• Systematic literature review

Burnard, K.J. (2024), "Developing a robust case study protocol", Management Research Review , Vol. 47 No. 2, pp. 204-225. https://doi.org/10.1108/MRR-11-2021-0821

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How to Write a Research Protocol: Tips and Tricks

Matteo cameli.

Department of Cardiovascular Diseases, University of Siena, Siena, Italy

Giuseppina Novo

1 Biomedical Department of Internal Medicine and Medical Specialties, Cardiology Unit, University of Palermo, Palermo, Italy

Maurizio Tusa

2 Division of Cardiology, IRCCS Policlinico San Donato, Italy

Giulia Elena Mandoli

Giovanni corrado.

3 Department of Cardiology, Valduce Hospital, Como, Italy

Frank Benedetto

4 Division of Cardiology, Bianchi-Melacrino-Morelli Hospital, Reggio Calabria, Italy

Francesco Antonini-Canterin

5 High Specialization Rehabilitation Hospital, ORAS, Motta di Livenza, Treviso, Italy

Rodolfo Citro

6 Heart Department, University Hospital “San Giovanni di Dio e Ruggi D’Aragona”, Salerno, Italy

The first drafting of the protocol for a new research project should start from a solid idea with one or more of these goals:

• Overcoming the limits of the current knowledge in a determinate field with the aim of bridging a “knowledge gap”
• Bringing something new in a scarcely explored field
• Validating or nullifying previous results obtained in limited records by studies on a wider population.

A research proposal born with the intent to convince the others that your project is worthy and you are able to manage it with a complete and specific work plan. With a strong idea in mind, it is time to write a document where all the aspects of the future research project must be explained in a precise, understandable manner. This will successively help the researcher to present it and process and elaborate the obtained results.[ 1 ] The protocol manuscript should also underline both the pros and the potentialities of the idea to put it under a new light.[ 2 ]

Our paper will give the authors suggestions and advices regarding how to organize a research protocol, step by step [ Table 1 ].

Main sections and subsections in a complete research protocol

A research protocol must start from the definition of the coordinator of the whole study: all the details of the main investigator must be reported in the first paragraph. This will allow each participant to know who ask for in case of doubts or criticalities during the research. If the study will be multicentric, in the first section must be written also the number of the involved centers, each one possibly matched with the corresponding reference investigator.

Second section: Specific features of the research study

After completing the administrative details, the next step is to provide and extend title of the study: This is made for identifying the field of research and the aim of the study itself in a sort of brief summary of the research; the title must be followed by a unique acronym, like an ID of the protocol. If the protocol has been already exposed and approved by the Ethical Committee, it is appropriate to include also protocol number.

A list of 3–7 keywords must be listed to simplify the collocation of the protocol in its field of research, including, for example, disease, research tools, and analyzed parameters (e.g. three-dimensional echocardiography, right ventricle, end-stage heart failure, and prognosis).

The protocol must continue stating the research background that is the rational cause on the base on which the study is pursued. This section is written to answer some of these questions: what is the project about? What is already available in this field in the current knowledge? Why we need to overcome that data? and How will the community will from the present study?

As for an original research manuscript, the introduction to the project must include a brief review of the literature (with corresponding references). It is also fundamental to support the premises of the study, to underline the importance of the project in that particular time period and above all, of the materials and methods that will be employed. The rationale should accurately put in evidence the current lack in that field of scientific knowledge, following a precise, logical thread with concrete solutions regarding how to overcome the gaps and to conclude with the hypothesis of the project. A distinct paragraph can be dedicated to references, paying attention to select only the previous papers that can help the reader to focus the attention on the topic and to not excessively extend the list. In the references paragraph, the main studies regarding the object of the research but also state-of-art reviews updating the most recent discoveries in the field should be inserted.

The section should successively expose the study design: monocentric or multicentric, retrospective or prospective, controlled or uncontrolled, open-label or blinded, randomized or nonrandomized, and observational or experimental. It should also be explained why that particular design has been chosen.

At this point, the author must include the primary objective of the research, that is, the main goal of the study. This is a crucial part of the proposal and more than 4–5 aims should be avoided to do not reduce the accuracy of the project. Using verbs as “to demonstrate,” “to assess,” “to verify,” “to improve,” “to reduce,” and “to compare” help to give relevance to this section. Add also a description of the general characteristics of the population that will be enrolled in the study (if different subgroups are planned, the criteria on the base of which they will be divided should be specified); primary and secondary end-points, including all the variables that represent the measure of the objective (e.g., all-cause death, cardiovascular death, hospitalization, and side effects of a drug) follow in this section.

All the single parameters and variables that will be assessed during the study must be accurately and precisely listed along with the tools, the methods, the process schedule timing, and the technical details by which they will be acquired; Here, the author should explain how the Investigators who work in the other involved centers have to sent their results and acquired data to the Core Laboratory (e.g. by filled databases or by sending images).

A special attention must then be paid to clarify the planning of each examination the study patients will undergo: basal evaluation, potential follow-up schedule, treatment strategy plan, comparison between new and already-in-use drugs, dose and dosage of the treatment in case of a pharmacological study. This part can be enhanced by flowcharts or algorithms that allow a more immediate comprehension and interpretation of the study strategy.

This section may result more complete if one more subsection, illustrating the expected results, is included. Considering the idea at the base on the project, the endpoints and the pre-arranged objectives, the author can explain how its research project will

• Contribute to optimize the scientific knowledge in that specific field
• Give real successive implications in clinical practice
• Pave the way for future scientific research in the same or similar area of interest, etc.

The study population must be specified in detail, starting from inclusion criteria (including age and gender if it is planned to be restricted) and exclusion criteria: the more precise are the lists, the more accurate the enrollment of the subjects will be to avoid selection biases. This will also help to raise the success rate of the project and to reduce the risks of statistical error during the successive analysis of the data. The sample size should be planned and justified on the base of a statistic calculation considering the incidence and prevalence of the disease, frequency of use of a drug, etc., and possibly also indicating if the study considers a minimal or maximal number of subjects for each enrollment center (in case of multicentric studies).

This section of the protocol should end with some indications regarding timing and duration of the study: Starting and end of enrollment date, starting and end of inclusion date, potential frequency of control examinations, and timing of the analysis of the acquired data. If already settled, it can be useful to indicate also the type of statistical analysis that the investigators will apply to the data.

It is always necessary to prepare an informed consent to be proposed to the patient where premises, methods, and aims of the research together with advantages (e.g., some visits or diagnostic examinations for free) and possible risks derived from the participation to the study.

In this short section, various pieces of information regarding safety of the study must be added (a classification is fundamental in case of studies that expect the use of invasive procedures or drugs use). Usually, for nonobservational studies, an insurance coverage must be considered.

If the investigators have requested or plan to request funding or financial support, all the obtained resources must be listed to avoid conflicts of interest.

C ONCLUSION

Writing a complete and detailed document is a paramount step before starting a research projects. The protocol, as described in this paper, should be simply and correctly written but must clarify all the aspects of the protocol. The document could be divided into three different sessions to give all the parts the appropriate attention.

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Article Contents

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

• Article contents
• Figures & tables
• Supplementary Data

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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THE CASE STUDY PROTOCOL

Research methodology.

The case study protocol defines the procedures and general rules to be followed using the protocol which is different from a survey questionnaire” (Yin, 2009, p. 79). The case study protocol and a survey questionnaire are both directed at a single data point, whether it’s a single case or a single respondent (Yin, 2009). A case study protocol is always needed when

performing a multiple-case study (Yin, 2009). The protocol is a major way of increasing the

reliability of case study research and is intended to guide the researcher in carrying out data

collection from a single case (Yin, 2009). A case study protocol should have at least the following sections (Yin, 2009, p. 81):

1. Overview of the case study project (project objectives and auspices, case study issues, and relevant readings about the topic being investigated).

2. 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).

3. Field procedures (the specific questions that the case study must keep in mind in collecting data, “table shells” for specific arrays of data, and the potential sources of information for answering each question …).

4. Investigator guide for the case study report (outline, format of the data, use and presentation of other documentation, and bibliographical information).

The importance of the protocol helps the researcher to remain focused on the topic and problem areas. This intuitive knowledge of the context and perspective will guide the researcher in the search for supporting information. By writing an overview of the case study, the researcher allows potential knowledge seeker to capitalize on the products of the case study and understand beforehand, the intent and depth of the case study research. There are also potential guidelines for field procedure. A researcher’s “field procedure of the protocol need to emphasize the major tasks in collecting data, including gaining access to key organizations or interviewees” (Yin, 2009, p. 85):

1. Having sufficient resources while in the field – including a personal computer, writing instruments, paper, paper clips, and a pre-established, quiet place to write notes privately.

2. Developing a procedure for calling for assistance and guidance, if needed, from other case study investigators or colleagues.

3. Making a clear schedule of the data collection activates that are expected to be completed within specified periods of time.

4. 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.

“The heart of the protocol is a set of substantive questions reflecting your actual line of inquiry” (Yin, 2009, p. 86). Each question should be “posed to you, the investigator, not to an

interviewee” and linked to a source of evidence (Yin, 2009, p. 86). Each question of this protocol should reflect a specific type/level potentially categorized by Yin’s five levels of questions below (Yin, 2009, p. 86):

1. Level 1: question asked of specific interviewees.

2. 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).

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

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

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

“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” (Yin, 2009, p. 88). “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 is about the organization, community, or social group” (Yin, 2009, p. 88). Table 6 below illustrates design verses data collection using different units of analysis:

Individual behavior Individual attitudes Individual perceptions

Individual employee records Interview with individual’s supervisor; other employees

How organization works

Why organization works Personnel policiesOrganization outcomes

Abo ut a n indi vidua l Abo ut a n or ga ni za tion De sig n

From an individual From an organization

Data Collection Source

Table 6: Design verses Data Collected

Table 6 above, Design verses Data Collection, helps the researcher to identify exactly what data is desired and ensures parallel information is collected from different sites as during a multiple case study (Yin, 2009, p. 89). The researcher should include an outline in the protocol to guide

in the collection, presentation, and formatting of data (Yin, 2009). This rigor allows other researchers to follow the case (Yin, 2009). The researcher may choose a pilot case to discover unforeseen issues or challenges (Yin, 2009). The protocol helps align the researcher’s data collection efforts.

The case study protocol defines the procedures and general rules to be followed using the protocol (Yin, 2009). Yin (2009) reminds the researcher that the protocol is a major way of increasing the reliability of case study research and is intended to guide the researcher in carrying out data collection from a single case. The case study protocol should contain at minimum the following sections (Yin, 2009): (1) Overview of the case study project; (2) Field procedures (credentials); (3) Field procedures (questions); and (4) a form of investigator guide for the case study report. The importance of the protocol helps the researcher to remain focused on the topic and problem areas. Design verses Data Collection helps the researcher to identify exactly what data is desired and ensures parallel information is collected from different (Yin, 2009). The case study protocol is used in the collection of case study evidence as described in the next section.

• PROJECT MANAGEMENT SYSTEMS (PMS)
• PMS: PMBOK PERSPECTIVE
• CYBERNETICS: PRELUDE TO THE VSM
• VIABLE SYSTEM MODEL (VSM)
• ORIGINS OF THE VSM
• SYSTEM FOUR
• CASE STUDY RESEARCH
• COMPONENTS OF RESEARCH DESIGN
• CASE STUDY DESIGNS
• THE CASE STUDY PROTOCOL (You are here)
• COLLECTING CASE STUDY EVIDENCE
• FRAMEWORK DEVELOPMENT
• DATA COLLECTION STRATEGIES
• ROLE OF THE RESEARCHER
• PROJECT Q: A CASE STUDY

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Alternative Quality Management Systems for Highway Construction (2015)

Chapter: appendix c: case study protocol.

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

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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Case Study Protocol for the Analysis of Sustainable Business Models

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• First Online: 22 June 2021
• Cite this conference paper

• Joaquin Sanchez-Planelles 3 &
• Marival Segarra-Oña 3  

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

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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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Joaquin Sanchez-Planelles & Marival Segarra-Oña

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Correspondence to Joaquin Sanchez-Planelles .

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University of West Attica, Athens, Greece

Vicky Katsoni

University of South Africa, Pretoria, South Africa

Ciná van Zyl

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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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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Barbosa, H.A.; Buriti, C.O.; Kumar, T.V.L. Deep Learning for Flash Drought Detection: A Case Study in Northeastern Brazil. Atmosphere 2024 , 15 , 761. https://doi.org/10.3390/atmos15070761

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Barbosa, Humberto A., Catarina O. Buriti, and T. V. Lakshmi Kumar. 2024. "Deep Learning for Flash Drought Detection: A Case Study in Northeastern Brazil" Atmosphere 15, no. 7: 761. https://doi.org/10.3390/atmos15070761

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Assessing biomarkers of remission in female patients with anorexia nervosa (REMANO): a protocol for a prospective cohort study with a nested case-control study using clinical, neurocognitive, biological, genetic, epigenetic and neuroimaging markers in a French specialised inpatient unit

Affiliations.

• 1 Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM U1266, Team "Vulnerability to Psychiatric and Addictive Disorders", Université Paris Cité, Paris, France [email protected].
• 2 Clinique des Maladies Mentales et de l'Encéphale, Hôpital Sainte-Anne, GHU Paris Psychiatrie et Neurosciences, Paris, France.
• 3 Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM U1266, Team "Vulnerability to Psychiatric and Addictive Disorders", Université Paris Cité, Paris, France.
• 4 Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM U1266, IMA-Brain, Université Paris Cité, Paris, France.
• 5 Service de Neuroradiologie, Hôpital Sainte-Anne, GHU Paris psychiatrie et neurosciences, Paris, France.
• 6 CNRS, UMR 9193 - SCALab - Sciences Cognitives et Sciences Affectives, University of Lille, Villeneuve d'Ascq, France.
• PMID: 38925688
• PMCID: PMC11208877
• DOI: 10.1136/bmjopen-2023-077260

Background: Anorexia nervosa (AN) is a severe psychiatric disorder associated with frequent relapses and variability in treatment responses. Previous literature suggested that such variability is influenced by premorbid vulnerabilities such as abnormalities of the reward system. Several factors may indicate these vulnerabilities, such as neurocognitive markers (tendency to favour delayed reward, poor cognitive flexibility, abnormal decision process), genetic and epigenetic markers, biological and hormonal markers, and physiological markers.The present study will aim to identify markers that can predict body mass index (BMI) stability 6 months after discharge. The secondary aim of this study will be focused on characterising the biological, genetic, epigenetic and neurocognitive markers of remission in AN.

Methods and analysis: One hundred and twenty-five (n=125) female adult inpatients diagnosed with AN will be recruited and evaluated at three different times: at the beginning of hospitalisation, when discharged and 6 months later. Depending on the BMI at the third visit, patients will be split into two groups: stable remission (BMI≥18.5 kg/m²) or unstable remission (BMI<18.5 kg/m²). One hundred (n=100) volunteers will be included as healthy controls.Each visit will consist in self-reported inventories (measuring depression, anxiety, suicidal thoughts and feelings, eating disorders symptoms, exercise addiction and the presence of comorbidities), neurocognitive tasks (Delay Discounting Task, Trail-Making Test, Brixton Test and Slip-of-action Task), the collection of blood samples, the repeated collection of blood samples around a standard meal and MRI scans at rest and while resolving a delay discounting task.Analyses will mainly consist in comparing patients stabilised 6 months later and patients who relapsed during these 6 months.

Ethics and dissemination: Investigators will ask all participants to give written informed consent prior to participation, and all data will be recorded anonymously. The study will be conducted according to ethics recommendations from the Helsinki declaration (World Medical Association, 2013). It was registered on clinicaltrials.gov on 25 August 2020 as 'Remission Factors in Anorexia Nervosa (REMANO)', with the identifier NCT04560517 (for more details, see https://clinicaltrials.gov/ct2/show/record/NCT04560517). The present article is based on the latest protocol version from 29 November 2019. The sponsor, Institut National de la Santé Et de la Recherche Médicale (INSERM, https://www.inserm.fr/), is an academic institution responsible for the monitoring of the study, with an audit planned on a yearly basis.The results will be published after final analysis in the form of scientific articles in peer-reviewed journals and may be presented at national and international conferences.

Trial registration number: clinicaltrials.gov NCT04560517 .

Keywords: Adult psychiatry; Eating disorders; Magnetic resonance imaging.

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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Conflict of interest statement

Competing interests: None declared.

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Chemotherapy-related cardiotoxicity and its symptoms in patients with breast cancer: a scoping review

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Chemotherapy-related cardiotoxicity is a significant concern because it is a major cause of morbidity. This study aimed to provide in-depth information on the symptoms of chemotherapy-related cardiotoxicity (CRCT) by exploring literature that concurrently reports the types and symptoms of CRCT in patients with breast cancer.

A scoping review was performed according to an a priori protocol using the Joanna Briggs Institute’s guidelines. The participants were patients with breast cancer. The concept was the literature of specifically reported symptoms directly matched with CRCT and the literature, in English, from 2010, and the context was open. The search strategy included four keywords: “breast cancer,” “chemotherapy,” “cardiotoxicity,” and “symptoms.” All types of research designs were included; however, studies involving patients with other cancer types, animal subjects, and symptoms not directly related to CRCT were excluded. Data were extracted and presented including tables and figures.

A total of 29 articles were included in the study, consisting of 23 case reports, 4 retrospective studies, and 2 prospective studies. There were no restrictions on the participants’ sex; however, all of them were women, except for one case report. The most used chemotherapy regimens were trastuzumab, capecitabine, and doxorubicin or epirubicin. The primary CRCT identified were myocardial dysfunction and heart failure, followed by coronary artery disease, pulmonary hypertension, and other conditions. Major tests used to diagnose CRCT include echocardiography, electrocardiography, serum cardiac enzymes, coronary angiography, computed tomography, and magnetic resonance imaging. In all case reports, CRCT was diagnosed through an incidental checkup according to the patient’s symptom presentation; however, only 10 of these studies showed a baseline checkup before chemotherapy. The five most common CRCT symptoms were dyspnea, chest pain, peripheral edema, fatigue, and palpitations, which were assessed by patient-reported symptom presentation rather than using a symptom assessment tool. Dyspnea with trastuzumab treatment and chest pain with capecitabine treatment were particularly characteristic. The time for first symptom onset after chemotherapy ranged from 1 hour to 300 days, with anthracycline-based regimens requiring 3–55 days, trastuzumab requiring 60–300 days, and capecitabine requiring 1–7 days.

Conclusions

This scoping review allowed data mapping according to the study design and chemotherapy regimens. Cardiac assessments for CRCT diagnosis were performed according to the patient’s symptoms. There were approximately five types of typical CRCT symptoms, and the timing of symptom occurrence varied. Therefore, developing and applying a CRCT-specific and user-friendly symptom assessment tool are expected to help healthcare providers and patients manage CRCT symptoms effectively.

Peer Review reports

Breast cancer is currently the most common cancer worldwide. Its incidence and mortality rates in East Asia in 2020 accounted for 24% and 20% of the global rates, respectively, and these rates are expected to continue increasing until 2040 [ 1 ]. In the USA, since the mid-2000s, the incidence rate of breast cancer has been increasing by 0.5% annually, while the mortality rate has been decreasing by 1% per year from 2011 to 2020 [ 2 ]. Despite the improved long-term survival rate in patients with breast cancer due to the development of chemotherapy, the literature has highlighted that cardiotoxicity, a cardiac problem caused by chemotherapy, could be a significant cause of death among these patients [ 3 ]. Chemotherapy-related cardiotoxicity (CRCT) can interfere with cancer treatment and progress to congestive heart failure during or after chemotherapy [ 4 ], potentially lowering the survival rate and quality of life of patients with cancer [ 5 ].

The term cardiotoxicity was first used in the 1970s to describe cardiac complications resulting from chemotherapy regimens, such as anthracyclines and 5-fluorouracil. The early definition of cardiotoxicity centered around heart failure, but the current definition is broad and still imprecise [ 6 ]. The 2022 guidelines on cardio-oncology from the European Society of Cardiology (ESC) define cardiotoxicity as including cardiac dysfunction, myocarditis, vascular toxicity, arterial hypertension, and cardiac arrhythmias. Some of these definitions reflect the symptoms. For example, cardiac dysfunction, which accounts for 48% of cardiotoxicity in patients with cancer, is divided into asymptomatic and symptomatic cardiac dysfunction. Asymptomatic cardiac dysfunction is defined based on left ventricular ejection fraction (LVEF), myocardial global longitudinal strain, and cardiac biomarkers. Symptomatic cardiac dysfunction indicates heart failure and presents with ankle swelling, breathlessness, and fatigue [ 7 ]. The ESC guidelines for heart failure present more than 20 types of symptoms [ 8 ]; however, to the best of our knowledge, few studies have been conducted to determine which heart failure symptoms and their characteristics are associated with CRCT in patients with breast cancer. Similarly, there is a lack of information related to vascular toxicity such as myocardial infarction [ 7 ].

Professional societies in cardiology and oncology have proposed guidelines for the prevention and management of cardiotoxicity in patients with cancer. According to the American Society of Clinical Oncology and the ESC, it is recommended to identify high-risk patients, comprehensively evaluate clinical signs and symptoms associated with CRCT, and conduct cardiac evaluations before, during, and after chemotherapy [ 7 , 9 , 10 ]. In addition, guidelines for patients with cancer, including those for breast cancer survivorship care, emphasize that patients should be aware of the potential risk of CRCT and report symptoms, such as fatigue or shortness of breath to their healthcare providers [ 7 , 11 , 12 ]. Although these guidelines encompass cardiac monitoring as well as symptom observation, many studies have focused solely on objective diagnostic tests, such as echocardiography, cardiac magnetic resonance, and cardiac biomarkers [ 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 ], which means that there is little interest in CRCT symptoms in patients under breast cancer care.

This lack of interest in CRCT symptoms may be related to the absence of a specific symptom assessment tool for CRCT. Symptom monitoring of CRCT in patients with breast cancer was conducted through patient interviews and reported using the appropriate terminology [ 23 ]. In terms of interviews, patients with cancer experienced the burden of expressing symptoms between cardiovascular problems and cancer treatment. Qualitative research on patients with cancer indicates that these patients experience a daily battle to distinguish the symptoms they experience during chemotherapy [ 24 ]. To reduce the burden of identifying CRCT symptoms, it is crucial to educate patients with breast cancer undergoing chemotherapy about these symptoms. To report cardiotoxicity, healthcare providers in oncology can use a dictionary of terms called the Common Terminology Criteria for Adverse Events (CTCAE) for reporting adverse events in patients with cancer [ 25 ]. Patients can also use Patient-Reported Outcome (PRO), which allows unfiltered reporting of symptoms directly to the clinical database [ 26 ]. PRO consists of 78 symptomatic adverse events out of approximately 1,000 types of CTCAE [ 27 ]. Basch et al. suggested that PRO could enable healthcare providers to identify patient symptoms before they worsen, thereby improving the overall survival rate of patients with metastatic cancer [ 28 ]. This finding implies that symptoms can provide valuable clues for enhancing the timeliness and accuracy of clinical assessments of CRCT [ 29 ]. Therefore, it is necessary to explore the scope of research focusing on CRCT symptoms for prevention and early detection of CRCT in patients with breast cancer. The detailed research questions are as follows:

What are the general characteristics of the studies related to CRCT in patients with breast cancer?

What diagnostic tools and monitoring practices are used to detect CRCT?

What are the characteristics and progression of symptoms associated with CRCT?

A scoping review is a research method for synthesizing evidence that involves mapping the scope of evidence on a particular topic [ 30 ]. It aims to clarify key concepts and definitions, identify key characteristics of factors related to a concept, and highlight gaps or areas for further research [ 30 ]. This study used a scoping review methodology based on the Joanna Briggs Institute (JBI) framework. The JBI methodology, refined from the framework initially developed by Arksey and O’Malley [ 31 ], involves developing a research question, establishing detailed inclusion and exclusion criteria, and selecting and analyzing literature accordingly [ 32 ]. In contrast to systematic reviews, scoping reviews can encompass a variety of study designs and are particularly suitable when the topic has not been extensively studied [ 33 ]; hence, the decision was made to conduct a scoping review.

Development of a scoping review protocol

To conduct this review, an a priori scoping review protocol was developed to enhance transparency and increase the usefulness and reliability of the results. The protocol included the title, objective, review questions, introduction, eligibility criteria, participants, concept, context, types of evidence source, methods, search strategy, source of evidence selection, data extraction, data analysis and presentation, and deviation from the protocol [ 34 ] (Supplementary File 1).

Eligibility criteria

A participant-concept-context (PCC) framework was constructed based on the following research criteria. The participants were patients with breast cancer. The concept was that studies that specifically reported symptoms directly matched to CRCT in patients with breast cancer and the literature, published in English since 2010, in line with the year the CRCT guidelines were announced by the Cardio-Oncology Society. The context was open. We included all types of research designs. The exclusion criteria were studies that included patients with other types of cancer, involved animal subjects, and reported symptoms not directly related to CRCT.

Search strategy

The keywords consisted of “breast cancer,” “chemotherapy,” “cardiotoxicity,” and “symptoms.” The keywords for “cardiotoxicity” were constructed according to the clinical cardiotoxicity report and ESC guidelines [ 7 , 35 ]. The keywords for “symptoms” included 40 specific symptoms of arrhythmia, heart failure, and cardiac problems [ 36 , 37 ] (Supplementary Table 1). We used PubMed, Embase, and CINAHL.

Source of evidence selection

Duplicate studies were removed using EndNote 21. The titles and abstracts were then reviewed according to the inclusion criteria, the primary literature was selected, and the final literature was selected through a full-text review. Any disagreements were resolved through discussions between the investigators.

Data extraction

The data from the literature included the general characteristics of the study, as well as information on the patients, chemotherapy, cardiotoxicity, and symptoms. The general characteristics of the study included author, publication year, country of origin, study design; patient information including sample size, sex, age, cancer type, and cancer stage; chemotherapy information including chemotherapy regimen; cardiotoxicity information including type of cardiotoxicity, diagnostic tests, and times of assessment; and symptom information including type of symptom, characteristics of symptom worsening or improvement, onset time, progression time, and time to symptom improvement. Information on whether to receive chemotherapy after the diagnosis of cardiotoxicity was explored.

Data analysis and presentation

The contents of the included studies were divided into three categories: (1) general characteristics, which encompassed study designs, patients, and medications; (2) type of CRCT and cardiac assessment for CRCT; and (3) characteristics and progression of the symptoms associated with CRCT. CRCT symptom-related data are presented in tables and figures.

In total, 487 studies were identified through database searches, and 116 duplicates were subsequently removed. After reviewing the titles and abstracts, we excluded 197 studies in which participants had cancers other than breast cancer, no symptoms, or symptom-related expressions. Of the remaining 174 studies, 146 were excluded after full-text review. Among the excluded studies, 79 were mainly clinical trials that the symptoms were not directly related to CRCT, 62 did not report specific symptoms, four were in the wrong population, and one was unavailable for full-text review. An additional study was included after a review of references, bringing the final count to 29 studies included in the analysis (Fig. 1 ).

Preferred reporting items for systematic reviews flowchart

General characteristics of studies including designs, sex and age, chemotherapy regimen, and CRCT criteria

Table 1 presents the general characteristics of the studies included in this review. The majority of these studies were published in the USA ( n =14), with Japan ( n =3), and Romania ( n =2) following. The study designs primarily consisted of case reports ( n =23), retrospective studies ( n =4), and prospective studies ( n =2).

All case reports involved female patients, except for one involving a male patient. Five quantitative studies did not specify or limit the sex of the participants, and one retrospective study included only female patients. In terms of cancer stage, the majority of studies involved patients with advanced breast cancer ( n =13), while a smaller number involved patients with early-stage breast cancer ( n =4). Twelve studies did not specify the cancer stage. Approximately 20 types of chemotherapy regimens are currently in use. Trastuzumab, which is a human epidermal growth factor receptor 2 (HER2) blocker, was mentioned in the majority of studies ( n =8), followed by capecitabine (an antimetabolite) ( n =7), and doxorubicin or epirubicin (anthracycline-based chemotherapy) ( n =6). Current chemotherapy and previous treatment methods were described together, with the exception of eight studies. Six quantitative studies defined the CRCT criteria, five of which were based on decreased LVEF and one of which was based on significant cardiac symptoms and/or electrocardiogram changes. Twenty-three case reports described the cardiovascular diagnosis as CRCT.

Diagnostic tools and monitoring practice for CRCT

Table 2 displays the types of CRCT, diagnostic tools, and times of cardiac assessment according to chemotherapy regimens. The most prevalent CRCT were myocardial dysfunction and heart failure, identified in 12 case studies, respectively. This was followed by coronary artery disease, represented in 8 case studies, pulmonary hypertension in 2 case studies, and a single case study of periaortitis. The most used test for diagnosing CRCT was echocardiography ( n =22), followed by EKG ( n =20), various types of cardiac enzymes ( n =16), coronary angiography (CAG, n =12), computed tomography ( n =6), and magnetic resonance imaging (MRI, n =4). Regarding the CRCT symptom assessment tools, the CTCAE was used in two studies, the New York Heart Association classification for heart failure in two studies, the dyspnea assessment scale in one study, and symptoms of cardiac origin, which consisted of chest pain, dyspnea, and palpitations in one study.

Regarding the times of cardiac evaluation, two studies performed regular cardiac checkups including before, during, and after chemotherapy. There were 10 case studies and six quantitative studies describing cardiac function testing before chemotherapy, of which seven studies performed regular cardiac screening tests and two studies mentioned cardiac screening even after the completion of chemotherapy. The frequency of regular checkups varied from every 3 months to every two to four cycles. In all case reports ( n =23), CRCT were diagnosed through incidental checkups based on patients’ symptom presentation, and in most cases, several tests were performed subsequentially for CRCT diagnosis. In one case study, cardiac evaluation was conducted 3 days after the patient’s initial symptom presentation, when the symptoms became more severe.

Characteristics and progression of symptoms associated with CRCT

Table 3 shows the descriptive scope of the CRCT-related symptoms according to the chemotherapy regimens used in the included studies. The mapping factors included initial symptoms, symptom onset or severity, symptom progression, medical management, and CRCT results. One of the most frequent symptoms associated with CRCT was dyspnea, which was discussed in 19 studies and described as difficulty in breathing, shortness of breath, or New York Heart Association (NYHA) class II or III. When dyspnea appeared as the initial symptom of CRCT, the symptom progression was worsening in eight case studies and persistent in two cases. Chest pain was described in 12 studies as a symptom characterized by a squeezing, tingling, burning, tightened, or atypical feeling that was relieved by rest and exacerbated by exertion. Other symptoms included peripheral edema ( n =6), fatigue ( n =5), and palpitation ( n =2). The symptoms were assessed by patient-reported symptom presentation rather than using a symptom assessment tool.

The symptoms could be categorized based on the type of chemotherapy regimens used. In the case studies involving anthracycline-based regimen and HER2 blockers, dyspnea was the most frequently observed symptom ( n =7), followed by peripheral edema ( n =2), and chest pain or discomfort ( n =2). In case studies where antimetabolites were used, specifically capecitabine, chest pain was a common and prominent symptom. This chest pain typically manifested between 1 and 7 days after drug administration and persisted until treatment. Notably, four out of seven patients reported this symptom on the first day of chemotherapy, according to the case reports. The time for first symptom onset after chemotherapy ranged from 1 hour to 300 days, with anthracycline-based regimens requiring 3–55 days, trastuzumab requiring 60–300 days, and capecitabine requiring 1–7 days. Figure 2 shows the progression of symptoms in case studies, detailing the time of symptom onset, the date of symptom reporting, and the date of treatment completion following the use of chemotherapy. The studies that did not specify any of the dates of symptom onset, reporting, and completion of treatment were excluded from the figure.

Figure 3 shows symptoms according to the main types of chemotherapy regimens reported in case studies. Dyspnea with trastuzumab and chest pain with capecitabine are particularly characteristic. A retrospective study included in this scoping review reported that chest pain was the most common symptom associated with capecitabine, followed by dyspnea and palpitation [ 40 ]. Furthermore, peripheral edema was primarily observed with anthracycline, alkylating, and HER2 blockers, while fatigue was noted with various anticancer drugs, irrespective of the type of chemotherapy regimen.

Ongoing chemotherapy was discontinued after CRCT was detected in 20 case studies. When patients presented symptoms indicative of CRCT, the majority were promptly hospitalized for further evaluation, medication, or interventional treatment. The majority of studies indicated the initiation of cardiac medication ( n =21), with three case studies involving coronary intervention and two involving treatment with wearable devices. Most management procedures were conducted in a general ward or an intensive care unit.

In most case studies, symptoms improved following cardiac treatment, with either complete or partial recovery of LVEF observed in 19 instances. However, a few studies reported a poor prognosis, including two instances of death. LVEF recovered in most patients within 6 months when treated with an anthracycline-based regimen and HER2 blockers (Fig. 2 ). A retrospective study reported that the rates of complete or partial recovery of CRCT following treatment with doxorubicin-based chemotherapy and trastuzumab were 42.9% and 86.1%, respectively [ 39 ]. Another retrospective study noted that the recovery time of CRCT when treated with HER2 blockers increased in correlation with the severity of the NYHA class, ranging from 8 to 80 weeks [ 38 ]. In the case of the antimetabolite capecitabine, all patients recovered within a day to a week, except one patient who did not recover.

This scoping review was conducted to explore the scope of studies focusing on CRCT symptoms, including the general characteristics of the studies, diagnostic tools, monitoring practices related to detecting CRCT, and the characteristics and progression of symptoms associated with CRCT. The primary findings of this review were as follows: (1) common symptoms related to CRCT and differences in symptoms according to the chemotherapy regimens used were identified; (2) the symptoms reported by the patient served as clues to suspect a specific type of CRCT; and (3) regular monitoring practices for CRCT prevention and detection were insufficient.

First, the current study identified common symptoms such as dyspnea, chest pain, peripheral edema, fatigue, and palpitation associated with CRCT, as well as variations in symptoms depending on the chemotherapy regimen used in patients with breast cancer. Among these symptoms, dyspnea, edema, and chest pain were frequently observed in patients receiving anthracycline-based and/or HER2 blocker drugs. These symptoms, which are associated with heart failure, appeared later compared to those observed with capecitabine, as depicted in Fig. 2 . This may be due to the known impact of anthracycline-based and/or HER2 blocker regimens on cardiomyocytes and other cells, leading to myocardial damage [ 42 ]. Therefore, the symptoms are related to heart failure, potentially resulting from the impairment of ventricular filling or ejection in patients undergoing treatment with these regimens [ 43 ].

In a similar vein, Attin et al. (2022) documented the occurrence of symptoms such as lower extremity edema, chest pain, difficulty breathing, and fatigue before the diagnosis of CRCT in women undergoing breast cancer treatment. They conducted a retrospective and longitudinal investigation of the symptoms, signs, and cardiac tests of 15 patients who experienced CRCT, using their electronic medical records. In their study, cardiotoxicity was defined by an echocardiogram or MRI showing a decrease in LVEF of 5 to 10%, with a specialist’s confirmation note. They compared the number of symptom occurrences during the first half of the year with those during the second half of the year prior to the diagnosis of cardiotoxicity. Specifically, the frequency of lower-extremity edema significantly increased from three occurrences in the first half of the year to 17 occurrences in the second half of the year. The frequency of symptoms for dyspnea and chest pain also increased from 10 and 8 times, respectively, to 16 and 14 times in the second half of the year. While there was limited information on the doses or timing of chemotherapy, 87% of the patients received the same chemotherapy regimens, namely anthracyclines and/or HER2 blockers [ 44 ]. This suggests that the increase in symptom occurrence over time may be related to the accumulation of anthracycline and the duration of anti-HER2 therapy [ 45 ].

Salyer et al. (2019) conducted a study on the prevalent symptoms of heart failure and their clustering. They identified three symptom clusters: sickness behavior, gastrointestinal disturbance, and discomfort of illness. Notably, dyspnea, edema, and pain were grouped into the discomfort of illness cluster, which aligns with the symptoms we observed in patients treated with anthracyclines and/or HER2 blockers [ 46 ]. Therefore, it is crucial for patients undergoing treatment with anthracyclines and/or HER2 blockers to be vigilant for symptoms such as dyspnea, edema, or chest pain, as these are indicative of heart failure.

Chest pain caused by vasospasm was a predominant symptom in patients taking antimetabolite regimens such as oral capecitabine, and it manifested as the following types of cardiotoxicities: vasospasm-related arrhythmia, myocardial disease, and ischemia [ 47 ]. Vasospasm can be triggered by endothelial dysfunction, hypersensitive vascular smooth muscle, reactive oxidative stress, or chemotherapy regimens [ 48 , 49 ]. According to previous studies, in patients using antimetabolite drugs such as 5-fluorouracil or capecitabine, chest pain was usually reported to occur from several hours to 72 hours after the first administration [ 47 , 50 , 51 , 52 , 53 ]. To detect chemotherapy-related coronary vasospasm in the early stage, it is recommended to carefully monitor typical or atypical symptoms of chest pain and EKG monitoring during drug infusion [ 54 ]. Muco et al. (2022) reported severe outcomes resulting from delayed management of vasospastic angina symptoms. The patient’s cardiac evaluation was performed 3 days after the onset of symptoms, and unfortunately, she did not recover from brain damage caused by coronary vasospastic sequelae. The authors stressed the importance of medical teams recognizing the symptoms of CRCT through vigilant monitoring and patient education [ 55 ].

As seen in the symptoms of CRCT caused by heart failure and vasospasm, careful observation of symptoms and conducting appropriate tests are crucial to prevent cardiotoxicity and minimize damage. These characteristics of CRCT and the associated symptoms related to chemotherapy regimens can provide crucial educational content for healthcare providers and patients preparing for chemotherapy. In addition, CRCT and symptom progression according to chemotherapy regimens could be used to formulate research questions for future systematic reviews.

Second, the preventive management of CRCT necessitates adherence to recommended guidelines. The 2022 ESC guidelines on cardio-oncology have updated the classification of CRCT and the monitoring protocols based on the chemotherapy regimens used [ 7 ]. The CRCT identified in the current study aligns with the drug toxicity outlined in the 2022 ESC guidelines. These guidelines advocate for regular cardiac monitoring before, during, and after chemotherapy to prevent and manage CRCT induced by anthracycline and HER2 blockers [ 7 , 12 ]. In this scoping review, two of 23 records described cardiac monitoring before, during, and after chemotherapy. An Australian multicenter study revealed that 59% of patients were referred to a cardiologist before CRCT occurred, but only 15% of patients diagnosed with CRCT had consulted a cardiologist before chemotherapy [ 41 ]. Given the declining mortality rates among cancer patients, managing CRCT requires a collaborative approach between oncology and cardiology to minimize mortality and morbidity in patients with breast cancer undergoing chemotherapy [ 7 ]. Therefore, it remains crucial to emphasize adherence to cardiac monitoring guidelines and foster cooperation between oncology and cardiology.

Additionally, symptom assessment is important for the early detection of patients with CRCT. The studies included in the current scoping review assessed whether patients’ symptoms could detect CRCT using interviews with patients, the New York Heart Association classification, a dyspnea assessment scale, and CTCAE tools. The United States National Cancer Institute recommends that healthcare providers use CTCAE and patients with cancer use PRO to report adverse events, including symptoms. CTCAE is a broad and comprehensive terminology that encompasses adverse events related to cancer treatment, has been used since the 1980s [ 25 ], and is not specialized in cardiotoxicity. Additionally, a discrepancy between CTCAE and PRO discovered that healthcare providers often underestimate both the incidence and duration of symptoms compared to the patients [ 56 , 57 , 58 ]. Specifically, healthcare providers tend to report symptom severity as lower than that reported by patients. For instance, there are notable discrepancies between healthcare providers and patients when reporting severe or very severe symptoms of fatigue, dyspnea, and limb edema in patients with early-stage breast cancer undergoing chemotherapy. The reported rates were 8% and 22% for fatigue, 0% and 4% for dyspnea, and 0% and 5% for limb edema, from healthcare providers and patients, respectively. Therefore, it is necessary to develop a user-friendly questionnaire to assess the various symptoms of CRCT.

Finally, we found that once CRCT was confirmed, cardiac treatment was promptly initiated and chemotherapy was frequently halted until CRCT resolution. A Delphi study on the use of anthracycline and trastuzumab proposed altering the treatment schedule or discontinuing treatment until there was an improvement in LVEF [ 59 ]. However, the professional societies did not provide definitive recommendations regarding continuing or ceasing ongoing chemotherapy. Instead, they suggested that the decision to continue or discontinue ongoing chemotherapy should be made based on the patient’s potential risks and benefits [ 60 ]. For example, Polk et al. (2016) reported that out of 22 patients with CRCT resulting from capecitabine, six continued medications with or without cardiac treatment; some of these patients experienced the same symptoms, while others did not exhibit significant symptoms [ 40 ]. Further research is required to explore the continuation or discontinuation of chemotherapy when CRCT is confirmed.

This study has some limitations. First, although we did not restrict the patients’ sex when reviewing the literature, most patients, except for one, were female. This may be related to the lower incidence of breast cancer in men. Second, although this scoping review mapped CRCT symptoms according to chemotherapy regimens, including anthracycline-based drugs, HER2 blockers, and antimetabolites, it did not cover cardiotoxicity related to other types of chemotherapy regimens. Thus, exploring the symptoms by focusing on expanded chemotherapy regimens and cardiovascular toxic diseases will assist in overcoming this limitation. Third, of the 29 studies, 23 were case reports with some grey literature, which may be justified by the nature of scoping reviews that allow for inclusion irrespective of the data source [ 61 ] and the study type. Experimental or observational clinical studies use objective criteria, such as diagnostic tests to generate primary evidence. However, case reports have led to new medical discoveries regarding the prevention and treatment of diseases [ 62 ]. Given the nature of case reports, specific symptoms that could provide clues for evaluating CRCT in patients with breast cancer are most often found in these reports. We incorporated grey literature to gather more comprehensive information on CRCT-related symptoms. However, to mitigate the potential issue of unverified quality in grey literature, we initially organized 16 studies from peer-reviewed literature and subsequently incorporated the grey literature into our findings. This approach helped to clarify the results of the peer-reviewed literature, particularly the types of chemotherapy regimens [ 63 ]. Finally, regarding the literature selection criteria, we examined articles written in English and published since 2010, the year the cardio-oncology guidelines were announced, thereby excluding articles published before 2010.

This scoping review allowed data mapping according to the study design and chemotherapy regimens. The key messages included a type of CRCT, cardiac assessment, and in-depth information regarding the CRCT symptoms. There were approximately five typical CRCT symptoms, including dyspnea, chest pain, peripheral edema, fatigue, and palpitations, and the timing of symptom occurrence varied. The symptoms were assessed by patient-reported symptom presentation rather than using a symptom assessment tool. Therefore, developing and applying a CRCT-specific and user-friendly symptom assessment tool are expected to help healthcare providers and patients manage CRCT symptoms effectively.

Availability of data and materials

The datasets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request.

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Acknowledgements

The authors thank Nawon Kim, a librarian at the Yonsei University Medical Library, for building search terms and guiding the database searches.

This research is supported by the Brain Korea 21 FOUR Project founded by the National Research Foundation (NRF) of Korea, Yonsei University College of Nursing.

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HK, BH, SK, and JP contributed to the study conception and design. The literature search and record screening were performed by HK and BH under the supervision of JP. Material preparation, data collection, and analysis were performed by HK, BH, and JP. The first draft of the manuscript was written by HK and JP commented on each updated version of the manuscript. The tables and figures were prepared by BH under the instruction of JP. SK helped to interpret the data and provided critical feedback on the manuscript. All authors read and approved the final manuscript.

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Kim, H., Hong, B., Kim, S. et al. Chemotherapy-related cardiotoxicity and its symptoms in patients with breast cancer: a scoping review. Syst Rev 13 , 167 (2024). https://doi.org/10.1186/s13643-024-02588-z

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Received : 25 December 2023

Accepted : 14 June 2024

Published : 27 June 2024

DOI : https://doi.org/10.1186/s13643-024-02588-z

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