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Editorial
The Experience of Trial Participation
KATIE FEATHERSTONE, PhD,
Glamorgan Building, King Edward VII Avenue, Cardiff University, Cardiff, CF10 3WT, UK. E-mail: FeatherstoneK@Cardiff.ac.uk The demand for evidence about the effectiveness of treatments has led to the increasing dominance in funded health services research of the randomized controlled trial (RCT). The RCT is widely recognized as the gold standard within clinical research. It is the most effective method available to minimize bias and provide valid answers to important clinical questions1. However, there is a growing awareness of issues associated with the quality of trials and their results, including questions about precision, bias and validity2. Textbooks and reports in journals such as this focus on the design, methods, and results of trials3-5, suggesting that each decision in the planning and design of a trial, from selecting the intervention, the population, and the aims of the trial, occurs in isolation and according to standard rules. However, trialists are becoming increasingly aware that decisions such as these may influence the behavioral dynamics of participation (of both recruiting clinicians and the eligible patient population) and may in turn affect the internal and external validity of a trial6. Thus both recruiting clinicians and participants are a potential source of bias. Surprisingly, so far little research has examined the patient's perspective of participation, and studies that have been conducted have tended to use hypothetical scenarios to determine willingness to participate among the public, potential trial populations, specific treatment groups, or racial and ethnic groups often underrepresented in trials, and the types of trials examined have predominantly been those for rare conditions (such as oncology)7 or trials that present specific ethical issues, for example pediatric trials8. Few studies have examined trials for common or chronic conditions. One exception is Pope, et al9, who point out in this issue that there is "a paucity of research on understanding (and patients' perceptions) of the consent process in clinical trials involving patients suffering from chronic diseases." While the authors must be commended for being one of the few to examine recall and understanding of informed consent for common chronic conditions, more studies are needed that explore the participant's perspective. There is a need for studies that do more than point out the flaws in current practice. The provision of information occurs within a social context, with trust and the quality of the doctor/patient relationship important. Attitudinal and psychological barriers, such as trust and the impulse to disregard potential risk, mean that even strict informed consent procedures do not guarantee understanding. Thus there are both conceptual and methodological problems with many of the studies, such as Pope, et al, that examine informed consent. One of the central problems is the difficulty of determining when informed consent has actually been achieved. The majority of studies such as this one are not from the patients' perspective and are based on recall rather than understanding. Often these studies fail to examine or define how these participants, clinicians, and researchers understand trial concepts. There is a small but increasing number of studies focusing on the perspectives of actual participants in trials, asking them to describe their experiences of participation and reflections on their motives for taking part, using in-depth, semi-structured interviews. There may be resistance to the use of such qualitative methodologies; however, Snowdon, et al8, Appelbaum, et al10, and Featherstone and Donovan11,12 have shown that approaches such as this can provide trialists with important insights into the practical barriers/problems of providing informed consent. In addition, there are a host of issues around the conduct and "natural history" of trials that may impact on the quality of the trial and that have yet to be adequately understood. These include practical, social, ethical, and study design issues13-15 such as the nature of the organizational context and everyday working practices that may influence the precision and validity of a trial. An examination of both the patients' and recruiting clinicians' perspectives of trial participation is crucial for both the ethics of running a trial and the validity and reliability of their findings. While the impetus to improve the process of providing informed consent, the experience of trial participation, and the reliability of trials must come from those running common pragmatic trials for common chronic and non-life threatening conditions such as arthritis and rheumatism. 1. Peto R, Baignent C. Trials; the next 50 years. BMJ 1998;317:1170-1171.[MEDLINE] 2. Baum M. Reflections on randomised controlled trials in surgery. Lancet 1999;353:6-8. [MEDLINE] 3. Pocock SJ. Clinical Trials: a practical approach. Chichester: Wiley; 1983. 4. Altman DG. Better reporting of randomised controlled trials: the CONSORT statement. BMJ 1996;313:570-1. [MEDLINE] 5. Senn S. Statistical issues in drug development. Chichester:John Wiley and Sons; 1997. 6. Leventhal H, Nerenz DR, Leventhal EA, Love RR, Bendena LM. The behavioural dynamics of clinical trials. Prev Med 1991;20: 132-46. [MEDLINE] 7. Smyth JF, Mossman J, Hall R, et al. Conducting clinical trials in the new NHS: the model of cancer. BMJ 1994;309:457-61. [MEDLINE] 8. Snowdon C, Garcia J, Elbourne D. Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Soc Sci Med 1997;45:1337-55. [MEDLINE] 9. Pope JE, Tingey, DP, Arnold MO, Hong P, Ouimen JM, Krizova A. Are subjects satisfied with the informed consent process? A survey of research participants. J Rheumatol 2003;30:815-24. 10. Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W. False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Report 1987; April:204. 11. Featherstone K, Donovan JL. Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial. BMJ 1998;317:1177-80. [MEDLINE] 12. Featherstone K, Donovan JL. "Why don't they tell me straight, why allocate it? The struggle to make sense of participation in a randomised controlled trial. Soc Sci Med 2002;55:709-19.[MEDLINE] 13. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiology 1999;52: 1143-56.[MEDLINE] 14. Taylor KM, Kelner M. Informed consent: the physicians' perspective. Soc Sci Med 1987;24:135-43. [MEDLINE] 15. Taylor KM, Kelner M. Interpreting physician participation in randomized clinical trials: The physician orientation profile. J Health Soc Behav 1987a;28:389-400. [MEDLINE] 16. Taylor KM. Integrating conflicting professional roles: physician participation in randomized clinical trials. Soc Sci Med 1992;35:217-24.[MEDLINE] |
