Signorell, Aita and Saric, Jasmina and Appenzeller-Herzog, Christian and Ewald, Hannah and Burri, Christian and Goetz, Martin and Gerold, Jana. (2021) Methodological approaches for conducting follow-up research with clinical trial participants: a scoping review and expert interviews. Trials, 22. p. 961.
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Official URL: https://edoc.unibas.ch/86125/
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Abstract
Evidence-based establishment and implementation of best principles, laws and ordinances that regulate clinical research depend on the consultation and involvement of trial participants. Yet, guidance on methodological approaches to obtain trial participants' perspectives is currently missing. This scoping review therefore aimed at identifying, describing and evaluating research approaches to obtain trial participants' feedback on their views and experiences.; We searched the electronic databases Medline and PsycInfo via Ovid and the Web of Science Core Collection. Clinical trials were included that involved adult participants that were conducted in selected high-income countries and that were published in peer-reviewed journals between 1985 and 2018. In addition, 29 expert interviews were conducted between March and May 2019.; Out of 5994 identified records, 23 articles were included in this review. Twelve studies used a qualitative approach, 10 were quantitative and one study used a mixed-method design. More than 75% of all work was conducted in the USA and the UK. The scoping review and the expert interviews highlighted that recruitment of participants was generally done through direct contact by principal investigators and/or study nurses or through searches in de-identified patient databases. Authors used surveys, interviews or focus group discussions. The tools used were either based on existing validated ones or developed and verified de novo with the support of experts and/or patient representatives.; To our knowledge, this is the first methodological literature review of approaches to researching experiences of clinical trial participants where findings were triangulated with expert interviews. Covering a range of indications, trial phases and study settings, it demonstrates that clinical trial participant perspectives and experience is heavily under-researched. This casts doubt on the overall robustness of available insight into trial participants' views and experiences. Our results demonstrate that the methodology for studying participant opinion, perception and experience should be adapted to the measure of interest and conform to the study population. Using valid patient experience data is the basis to evaluate existing legal and regulatory human subject research frameworks for their appropriateness from a patient perspective. Such an evaluation will be critical to empower research participants.
Faculties and Departments: | 10 Zentrale universitäre Einrichtungen > Universitätsbibliothek 09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Medicine (MED) > Medicines Implementation Research (Burri) 09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Swiss Centre for International Health (SCIH) > Systems Strengthening and Health Promotion (Prytherch) |
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UniBasel Contributors: | Appenzeller-Herzog, Christian and Signorell, Aita and Saric, Jasmina and Ewald, Hannah and Burri, Christian and Gerold, Jana |
Item Type: | Article, refereed |
Article Subtype: | Research Article |
Publisher: | BMC |
ISSN: | 1468-6708 |
e-ISSN: | 1745-6215 |
Note: | Publication type according to Uni Basel Research Database: Journal article |
Language: | English |
Identification Number: |
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edoc DOI: | |
Last Modified: | 24 Oct 2023 09:35 |
Deposited On: | 03 Mar 2022 15:33 |
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