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• W2783232152 abstract "INTRODUCTION : Randomized control trials (RCTs) are considered to provide the least biased method of evaluating the efficacy of drugs and other interventionsused in healthcare [1]. Well conducted RCTs form an integral part of the external research evidence that is meant to be summarised in systematic reviews and incorporated with clinical expertise, and the values and preferences of patients, in the endeavour called “Evidence-Based Medicine” [2]. For RCTs to produce valid and reliable results, their methods need to be robust in order to ensure that biases have been minimised, and that known and unknown confounders are balanced across treatment arms at the start of the trial [3, 4]. However, these methods used in RCTs that increase the reliability of their results differ from the components of clinical care that patients and their relatives expect from clinicians. This may give rise to ethical issues when vulnerable populations are enrolled in such trials without fully appreciating the potential risks involved, and the deviations in clinical trials from usual clinical practice. OBJECTIVES : To understand the perspectives of Indian patients undergoing treatment for major psychiatric disorders, and of their relatives, regarding participation in randomised clinical trials,and to assess their competence to consent. METHODS : A cross-sectional quantitative and qualitative study using the “Prospective Preference Assessment” method on moderately-ill, consenting, psychiatric inpatients, and their relatives, assessed their attitudes to participation in randomised clinical trials (RCTs); their comprehension about information regarding two hypothetical trials; their willingness to participate; and the barriers and facilitators to participation. Clinical assessments of the capacity to consent were supplemented, in a sub-set, by independent assessments using the MacArthur Competence Assessment Tool for Clinical Research (MaCAT-CR). Quantitative data were presented as frequencies and qualitative data from audio-recorded, verbatim transcripts, were analysed for themes using the “Grounded Theory” framework. RESULTS : All twenty participants (9 patients, 11 relatives) endorsed the need for RCTs and their methods; and altruism as a motive for participation. Only 50% were willing to participate in the hypothetical trials. Comprehension of information sheets was sub-optimal. Trust in doctors and organisations, and the opinions of family members’ facilitated participation. Unfavourable risk/benefit ratios, the use of placebos, distrust in doctors and organisations, financial and other hardships, and opinions of family members were barriers. The majority of participants judged competent on clinical assessment failed formal tests of competence to consent. CONCLUSION : This cross-sectional study using quantitative and qualitative methods and using the Prospective Preference method to ascertain the views of psychiatric patients and their relatives towards participation in clinical trials revealed that while patients and participants consider it necessary to conduct RCTs for scientific purposes and consider participation in these trials as an altruistic imperative, and the methods of RCTs that increase internal validity appropriate; their willingness to participate in such trials are likely to be increased by trust in their doctors and the organisations they represent, as well as by personal health and financial benefits, and the opinions of family members; and reduced by a variety of factors that include potential risks and burdens associated with trial participation. Comprehension of information required to provide valid consent is likely to be sub-optimal, but could be enhanced by conversation and repeated explanations, supplementing written information. Even then, roughly 50% approached to participate in such trials are likely to refuse participation. The prospective preference method has value in informing the design of future trials. Finally, formal assessments of the capacity to consent is routinely recommended in trials involving psychiatric patients, even if clinical assessments indicate that eligible participants have the capacity to consent to participate in clinical trials." @default.
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• W2783232152 date "2013-04-01" @default.
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• W2783232152 title "Assessment of Attitudes Towards Participation, Willingness to Participate, and Competence to Participate in Randomised Control Trials: A Cross Sectional Qualitative and Quantitative Survey of Psychiatric Patients and Key Family Members Using the “Prospective Preference Assessment” Method and the Macarthur Competence Assessment Tool for Clinical Research (MaCAT-CR)." @default.
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