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Increasing protocol suitability for clinical trials in sub-Saharan Africa: a mixed methods study

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      Abstract

      BackgroundThe trial protocol is the most important document for clinical trials and describes not only the design and methodology of a study, but also all practical aspects. The suitability of the protocol has a direct impact on the execution and results of the trial. However, suitability is rarely addressed in trial practice and research. The aim of our study was to investigate protocol suitability and to identify suitability-enhancing measures for trials in sub-Saharan Africa.MethodsWe used an exploratory mixed methods design. First, we interviewed 36 trial staff at different organisational levels in Ghana, Burkina Faso and Senegal. Second, we conducted an online survey among trial staff in sub-Saharan Africa to investigate trial protocol suitability based on the main themes distilled from the interviews.ResultsProtocol suitability surfaced as a prominent topic in interviews with trial staff, critiqued for its lack of clarity, implementability and adaptation to trial participants as well as to the workforce and infrastructure available. Both qualitative and quantitative investigations identified local site staff involvement in protocol development as the most helpful mean of increasing protocol suitability. Careful assessment of the local context, capacity and cultures, and ensuring that staff understand the protocol were also cited as helpful measures.ConclusionsOur data suggests that protocol suitability can be increased by discussing and reviewing the protocol with trial staff in advance. Involving operationally experienced staff would be most useful. For multicentre trials, we suggest that at least one trial staff member from each of the sites with the highest expected recruitment rates be involved in developing the protocol. Carefully assessing the context prior to study start is indispensable to ensuring protocol suitability and should particularly focus on the workforce and infrastructure available, as well as the needs and availability of trial participants. To allow for protocol suitability enhancing measures, planners must allocate enough time for trial preparation and solicit feedback and information on context at an early stage. Such prospective planning would increase implementability, efficiency and quality of trials in the long run.Electronic supplementary materialThe online version of this article (doi:10.1186/s41256-017-0031-1) contains supplementary material, which is available to authorized users.

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      Most cited references 36

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      Using thematic analysis in psychology

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        Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups.

        Qualitative research explores complex phenomena encountered by clinicians, health care providers, policy makers and consumers. Although partial checklists are available, no consolidated reporting framework exists for any type of qualitative design. To develop a checklist for explicit and comprehensive reporting of qualitative studies (in depth interviews and focus groups). We performed a comprehensive search in Cochrane and Campbell Protocols, Medline, CINAHL, systematic reviews of qualitative studies, author or reviewer guidelines of major medical journals and reference lists of relevant publications for existing checklists used to assess qualitative studies. Seventy-six items from 22 checklists were compiled into a comprehensive list. All items were grouped into three domains: (i) research team and reflexivity, (ii) study design and (iii) data analysis and reporting. Duplicate items and those that were ambiguous, too broadly defined and impractical to assess were removed. Items most frequently included in the checklists related to sampling method, setting for data collection, method of data collection, respondent validation of findings, method of recording data, description of the derivation of themes and inclusion of supporting quotations. We grouped all items into three domains: (i) research team and reflexivity, (ii) study design and (iii) data analysis and reporting. The criteria included in COREQ, a 32-item checklist, can help researchers to report important aspects of the research team, study methods, context of the study, findings, analysis and interpretations.
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          SPIRIT 2013 statement: defining standard protocol items for clinical trials.

          The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
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            Author and article information

            Affiliations
            [1 ]ISNI 0000 0004 0587 0574, GRID grid.416786.a, Department of Medicines Research, , Swiss Tropical and Public Health Institute, ; Socinstrasse 57, 4051 Basel, Switzerland
            [2 ]ISNI 0000 0004 1937 0642, GRID grid.6612.3, University of Basel, ; Petersplatz 1, 4003 Basel, Switzerland
            [3 ]ISNI 0000 0004 0587 0574, GRID grid.416786.a, Department of Epidemiology and Public Health, , Swiss Tropical and Public Health Institute, ; Socinstrasse 57, 4051 Basel, Switzerland
            Contributors
            ORCID: http://orcid.org/0000-0002-1030-6359, Nerina.vischer@unibas.ch
            Constanze.pfeiffer@unibas.ch
            Jennifer.kealy@unibas.ch
            Christian.burri@unibas.ch
            Journal
            Glob Health Res Policy
            Glob Health Res Policy
            Global Health Research and Policy
            BioMed Central (London )
            2397-0642
            7 April 2017
            7 April 2017
            2017
            : 2
            5683382
            31
            10.1186/s41256-017-0031-1
            © The Author(s) 2017

            Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

            Funding
            Funded by: Geigy Stiftung
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            Funded by: Burckhardt-Bürgin-Stiftung
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            Award Recipient :
            Funded by: FundRef http://dx.doi.org/10.13039/100009736, Freiwillige Akademische Gesellschaft;
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            Categories
            Research
            Custom metadata
            © The Author(s) 2017

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