Factors associated with patient willingness to participate in anaesthesia clinical trials: a vignette-based cross-sectional study

Article Article scientifique Article Factors associated with patient willingness to participate in anaesthesia clinical trials: a vignette-based cross-sectional study eng 2020-03-19 2020-03-19 author Noirmain Caroline 634388 author Gil-Wey Béatrice Margrith 675152 author Pichon Isabelle author Brindel Pauline 924628 author Haller Guy Serge Antoine 28638 67 10.1186/s12874-020-00949-5 32192447 1471-2288 PMC7082904 https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-020-00949-5 Background: Clinical trials are essential to improve knowledge of anesthesia and perioperative medicine. Unfortunately, many studies face participant-recruitment issues and fail to include the planned number of participants. There is limited published data about how information delivered about the study or how the experiences and attitudes of prospective participants influence willingness to participate. The purpose of this study was to identify such factors in the domain of anesthesia care. Methods: We performed a cross-sectional study at the Geneva University Hospitals (Switzerland) using a newly developed paper-based questionnaire on a sample of outpatients with a recent hospital stay and that were aged over 18 years, confident speaking French and free of any disease that could hinder participation. We explored patient personal factors, such as current health, past exposure to clinical research and anesthesia, as well as study-related factors. Six different scenarios for clinical studies were assessed. Linear regression modeling was used to assess the specific association between personal and study-related factors and willingness to participate in the studies described in the scenarios. Results: On the 1318 eligible patients, 398 fully completed the questionnaire. Multivariable adjustment revealed that factors related to altruistic values (β, 9.6, 95% CI 3.4 to 15.7, P = 0.002), to the feeling of benefiting from a more effective treatment (β, 4.7, 95% CI 0.2 to 9.2, P = 0.041) and to the absence of fear about double blinding (β, 5.7, 95% CI 1.3 to 10.2, P = 0.012) were positively associated with willingness to participate. Conversely, concerns about drug-related adverse effects (β, - 11.7, 95% CI - 16.9 to - 6.5, P < 0.001) and anxiety about surgery (β, - 5.2, 95% CI - 10.0 to - 0.5, P = 0.031) were negatively associated with willingness to participate. Conclusion: Our study was based on vignettes illustrating typical scenarios of clinical trials performed in anesthesia. However, their similarities with real studies still remains hypothetical and our results should be interpreted as such. Nevertheless, the study contributes to improve understanding of factors that may act as incentives or barriers to participation in clinical trials. It highlights the importance of providing appropriate information and reassurance to patients. Anesthesia Clinical trials Willingness to participate, reasons for refusal Adult Anesthesia Clinical Trials as Topic Cross-Sectional Studies Humans Middle Aged Motivation Patient Participation Prospective Studies Surveys and Questionnaires Switzerland Dewey 613 Dewey 617 63 Département d'anesthésiologie, pharmacologie, soins intensifs et urgences 229 64 Département de santé et médecine communautaires 22A false 88 Epidémiologie clinique et biostatistique 115 BMC Medical research methodology 20 1 eee075aa-c487-4dcb-9fb7-67dbf6890c32 Article (Published version) Public Article-scientifique-from-unpaywall.pdf 592568 application/pdf CC BY-4.0 83accf68-f7b1-4da0-8ee0-d092f15fc146 Appendix Public 12874_2020_949_MOESM1_ESM.docx 77194 application/vnd.openxmlformats-officedocument.wordprocessingml.document openAccess Faculté de médecine / Section de médecine clinique / Département d'anesthésiologie, pharmacologie, soins intensifs et urgences Faculté de médecine / Section de médecine clinique / Département de santé et médecine communautaires

Title	Published in	Year	Views	Downloads

Factors associated with patient willingness to participate in anaesthesia clinical trials: a vignette-based cross-sectional study	BMC Medical research methodology	2020	248	327
Evidence of survival benefit was often ambiguous in randomized trials of cancer treatments	Journal of Clinical Epidemiology	2020	416	404

Archive ouverte UNIGE

Brindel, Pauline