Study design factors influencing patients' willingness to participate in clinical research: a randomised vignette-based study

Angèle Gayet-Ageron, Sandrine Rudaz, Thomas Perneger, Angèle Gayet-Ageron, Sandrine Rudaz, Thomas Perneger

Abstract

Background: High patient participation in clinical research reduces selection bias and ensures the generalizability of study findings. We explored study-related factors that may influence patients' willingness to participate in research.

Methods: We submitted by mail two vignettes that described clinical research studies - a drug trial and a diagnostic study - to patients recently discharged from hospital and assessed their willingness to participate. We used a factorial design to randomly allocate three study attributes per vignette: in the drug trial, presumed superiority of new drug versus equipoise, public versus industry funding, and random versus non-random treatment allocation; in the diagnostic study, common versus rare disease, genetic versus protein analysis, and automatic reporting of results versus reporting on request.

Results: Of 2600 patients contacted, 1140 (44%) participated. Globally, willingness to participate in a drug trial was lower than in a diagnostic study (44.8% vs. 76.2%; P < 0.001). In the drug trial, participation was significantly higher when the new drug was presented as presumably better than the old (vs. equipoise) and when the study was funded by public sources (vs. industry), but was not affected by the allocation method. None of the factors tested in the diagnostic study was associated with participation.

Conclusions: Patients were more likely to participate in a hypothetical observational diagnostic study than in a hypothetical drug trial. Participation in the trial was lower when clinical equipoise was expressed and when the trial was funded by industry. These results suggest that some features of study design can influence participation.

Keywords: Clinical equipoise; Clinical research; Controlled trials; Patient participation; Randomization; Study design.

Conflict of interest statement

None declared.

Figures

Fig. 1
Fig. 1
Distribution of the percentages of answers of participants regarding their willingness to be enrolled in a fictive clinical trial assessing the effect of a a new respiratory drug and b a new diagnostic test

References

    1. Cullati S, Courvoisier DS, Gayet-Ageron A, Haller G, Irion O, Agoritsas T, Rudaz S, Perneger TV. Patient enrollment and logistical problems top the list of difficulties in clinical research: a cross-sectional survey. BMC Med Res Methodol. 2016;16:50. doi: 10.1186/s12874-016-0151-1.
    1. Galea S, Tracy M. Participation rates in epidemiologic studies. Ann Epidemiol. 2007;17:643–653. doi: 10.1016/j.annepidem.2007.03.013.
    1. Trauth JM, Musa D, Siminoff L, Jewell IK, Ricci E. Public attitudes regarding willingness to participate in medical research studies. J Health Soc Policy. 2000;12:23–43. doi: 10.1300/J045v12n02_02.
    1. Kurt A, Kincaid HM, Curtis C, Semler L, Meyers M, Johnson M, Careyva BA, Stello B, Friel TJ, Knouse MC, Smulian JC, Jacoby JL. Factors influencing participation in clinical trials: emergency medicine vs. other specialties. West J Emerg Med. 2017;18:846–855. doi: 10.5811/westjem.2017.5.33827.
    1. Moocraft SY, Marriott C, Peckitt C, Cunningham D, Chau I, Starling N, Watkins D, Rao S. Patients’ willingness to participate in clinical trials and their views on aspects of cancer research: results of a prospective patient survey. Trials. 2016;17:17–28. doi: 10.1186/s13063-015-1105-3.
    1. McCann SK, Campbell MK, Entwistle VA. Reasons for participating in randomised controlled trials: conditional altruism and considerations for self. Trials. 2010;11:31–41. doi: 10.1186/1745-6215-11-31.
    1. Mattson ME, Curb DJ, McArdle R, the Aspirin Myocardial Infarction Study and Beta Blocker Heart Attack Trial Research Groups Participation in a clinical trial: the patients’ point of view. Control Clin Trials. 1985;6:156–167. doi: 10.1016/0197-2456(85)90121-7.
    1. Madsen S, Holm S, Riis P. Ethical aspects of clinical trials: the attitudes of the public and out-patients. J Intern Med. 1999;245:571–579. doi: 10.1046/j.1365-2796.1999.00502.x.
    1. Jones CW, Braz VA, McBride SM, Roberts BW, Platts-Mills TF. Cross-sectional assessment of patient attitudes towards participation in clinical trials: does making results publicly available matter? BMJ Open. 2016;6:e013649. doi: 10.1136/bmjopen-2016-013649.
    1. Jenkins V, Farewell V, Farewell D, Darmanin J, Wagstaff J, Langridge C, Fallowfield L. Drivers and barriers to patient participation in RCTs. Br J Cancer. 2013;108:1402–1407. doi: 10.1038/bjc.2013.113.
    1. Jenkins V, Farewell D, Batt L, Maughan T, Branston L, Langridge C, Parlour L, Farewell V. The attitudes of 1066 patients with cancer towards participation in randomised clinical trials. Br J Cancer. 2010;103:1801–1807. doi: 10.1038/sj.bjc.6606004.
    1. Locock L, Smith L. Personal benefit, or benefiting others? Deciding whether to take part in clinical trials. Clin Trials. 2011;8:85–93. doi: 10.1177/1740774510392257.
    1. Agoritsas T, Perneger TV. Patient-reported conformity of informed consent procedures abd participation in clinical research. Q J Med. 2011;104:151–159. doi: 10.1093/qjmed/hcq172.
    1. Welton AJ, Vickers MR, Cooper JA, Meade TW, Marteau TM. Is recruitment more difficult with a placebo arm in randomised controlled trials? A quasirandomised, interview based study. BMJ. 1999;318:1114–1117. doi: 10.1136/bmj.318.7191.1114.
    1. Gayet-Ageron A, Rudaz S, Perneger T. Biobank attributes associated with higher patient participation: a randomized study. Eur J Hum Genet. 2016;25:31–36. doi: 10.1038/ejhg.2016.132.
    1. Cassileth BR, Lusk EJ, Miller DS, Hurwitz S. Attitudes toward clinical trials among patients and the public. JAMA. 1982;248:968e70. doi: 10.1001/jama.1982.03330080050028.
    1. Verheggen FWSM, Nieman F, Jonkers R. Determinants of patient participation in clinical studies requiring informed consent: why patients enter a clinical trial. Patient Educ Couns. 1998;35:111–125. doi: 10.1016/S0738-3991(98)00060-3.
    1. Lifford R. Equipoise and the ethics of randomization. J Royal Soc Med. 1995;88:552–559.
    1. Featherstone K, Donovan JL. Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial. BMJ. 1998;317:1177–1180. doi: 10.1136/bmj.317.7167.1177.
    1. Ross S, Grant A, Counsell C, Gillepsie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999;52:1143–1156. doi: 10.1016/S0895-4356(99)00141-9.
    1. Jenkins V, Fallowfield Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy. Br J Cancer. 2001;82:1783–1788. doi: 10.1054/bjoc.2000.1142.
    1. Agoritsas T, Deom M, Perneger TV. Study design attributes influenced patients’ willingness to participate in clinical research: a randomized vignette-based study. J Clin Epidemiol. 2011;64:107–115. doi: 10.1016/j.jclinepi.2010.02.007.
    1. Dias AL, Chao JH, Lee D, Kloecker GH. Patient perceptions concerning clinical trials in oncology patients. Contemp Clin Trials Commun. 2016;4:179–185. doi: 10.1016/j.conctc.2016.09.005.
    1. Ellis PM, Butow PN, Tattersall MHN, Dunn SM, Houssami N. Randomized clinical trials in oncology: understanding and attitudes predict willingness to participate. J Clin Oncol. 2001;19:3554–3561. doi: 10.1200/JCO.2001.19.15.3554.
    1. Wazana A. Physicians and the pharmaceutical industry. Is a gift ever just a gift? JAMA. 2000;283:373–380. doi: 10.1001/jama.283.3.373.
    1. Choudhry NK, Stelfox HT, Detsky AS. Relationship between authors of clinical practice guidelines and the pharmaceutical industry. JAMA. 2002;287:612–617. doi: 10.1001/jama.287.5.612.
    1. Steinbrook R. Financial support of continuing medical education. JAMA. 2008;299:1060–1062. doi: 10.1001/jama.299.9.1060.
    1. Kemp N, Skinner E, Toms J. Randomized clinical trials of cancer treatment--a public opinion survey. Clin Oncol. 1984;10:155–161.
    1. Shalowitz DI, Miller FG. Communicating the results of clinical research to participants: attitudes, practices, and future directions. PLoS Med. 2008;5:714–720. doi: 10.1371/journal.pmed.0050091.
    1. Kerath SM, Klein G, Kern M, Shapira I, Witthuhn J, Norohna N, Line M, Baksh F, Gregersen P, Taioli E. Beliefs and attitudes towards participating in genetic research - a population based cross-sectional study. BMC Public Health. 2013;13:114. doi: 10.1186/1471-2458-13-114.
    1. Rice MS, Custer BS, Hindes DA, Hirschler NV, Nguyen KA, Busch MP, Murphy EL. Genetic research in the blood bank: acceptability to northern California donors. Transfusion. 2010;50:1951–1958. doi: 10.1111/j.1537-2995.2010.02741.x.
    1. Redelmeier DA, Rozin P, Kahneman D. Understanding patients' decisions: cognitive and emotional perspectives. JAMA. 1993;270:72–76. doi: 10.1001/jama.1993.03510010078034.

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
購読する