Abstract:
BACKGROUND:The comprehension of informed consent is an integral part of clinical trials. Though India is rapidly becoming a hub of clinical trials very few studies have dealt with the issue of comprehension of informed consent by the patients participating in these trials. METHODS:Patients who were invited to participate in a phase 3 multicentric trial of a novel lipid lowering agent were evaluated for comprehension score. The participants were explained about the structured consent form which included the question on background details for the study, design of the study, rights of the patients and miscellaneous aspects pertinent to the clinical trial. The questionnaire comprised of 24 items and each correct answer was assigned a score of 1. Total comprehension score (CS) was obtained by summing all the scores. RESULTS:Participants were from diverse socio economic and educational backgrounds. The mean +/- SD CS achieved by the participants was 13.4 +/- 2.9; median 14(6 to 20). The highest correct responses were obtained for questions on background details (38%). For most of the categories the mean CS was more than 50%. Aspects related to design were mostly difficult to comprehend. No significant difference in the CS was noted between participants from different educational and socioeconomic groups. 8 patients refused to give consent, fear of adverse drug reactions (n = 3) and inability to follow up (n = 5) were the reasons cited by the patients. CONCLUSION:In conclusion, CS of patients in trials conducted in developing countries can be reasonably good if the investigators explain the consent form in simple language to the participants and CS is not related to the educational status of the participants. Moreover, though a larger majority of patients agree to participate after knowing study details, some patients exercise their right to refuse.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Bhansali S,Shafiq N,Malhotra S,Pandhi P,Singh I,Venkateshan SP,Siddhu S,Sharma YP,Talwar KKdoi
10.1016/j.cct.2009.03.005subject
Has Abstractpub_date
2009-09-01 00:00:00pages
427-30issue
5eissn
1551-7144issn
1559-2030pii
S1551-7144(09)00045-7journal_volume
30pub_type
杂志文章,多中心研究abstract::Behavioral weight loss programs help people achieve clinically meaningful weight losses (8-10% of starting body weight). Despite data showing that only half of participants achieve this goal, a "one size fits all" approach is normative. This weight loss intervention science gap calls for adaptive interventions that pr...
journal_title:Contemporary clinical trials
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journal_title:Contemporary clinical trials
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journal_title:Contemporary clinical trials
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
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pub_type: 杂志文章,评审
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
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journal_title:Contemporary clinical trials
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journal_title:Contemporary clinical trials
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journal_title:Contemporary clinical trials
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