Main Organiser

Julius Centre University of Malaya

Co-organiser

Department of Social and Preventive Medicine, Faculty of Medicine, University of Malay

Supported by

University of Malaya

EXTENDED DISCUSSION OF INFORMATION FOR INFORMED CONSENT FOR PARTICIPATION IN CLINICAL TRIALS

Author

Yoon Khee H, Punitha N, Pik Pin G

Institution

Clinical Research Centre of Hospital Kuala Lumpur,
Clinical Research Centre of Hospital Pulau Pinang

Abstract

Objectives: To assess the effects of 'extended discussion' compared with convention method of informed consent for participation in clinical trials for understanding, willingness to participate and anxiety.

Methods: This systematic review is conducted based on the following methodology:- (i)Search methods:- Criteria for considering studies for this review Types of studies: Randomized controlled trials Types of participants:- (1)Participants delivering the intervention (2)Participants receiving the intervention. Types of interventions:- (1)Planned 'extended discussion' incorporated into the informed-consent process, prior to participation in a clinical trial. (2)The comparator intervention is defined as the conventional approach to inviting informed-consent prior to participation in a clinical trial. (ii)Selection criteria:- Types of outcome measures Both primary and secondary outcomes have been developed to address the needs of both consumers of clinical research. Details of search methods for identification of studies and of data collection and analysis are based on standards as stipulated by The Cochrane Handbook for Systematic Reviews of Interventions, with incorporation of specific recommendations from Cochrane Consumers and Communication Review Group. Sub-sections of data collection and analysis include:- Selection of studies Data extraction and management Assessment of risk of bias in included studies Measures of treatment effect Unit of analysis issues. Dealing with missing data Assessment of heterogeneity Assessment of reporting biases Data synthesis Subgroup analysis and investigation of heterogeneity Sensitivity analysis Since this protocol of Cochrane systematic review is still currently under review by both managing editor and coordinating editor of the Cochrane Consumers and Communication Review Group, both results and conclusions are currently unavailable.

Results : None

Conclusion : None