In the past decade, recommendations and user’s guides for evaluating, reporting, and interpreting health related quality of life (HRQL) outcomes from randomised controlled trials have been published, but disappointingly few of the standards are translated into practice. In a recent review of 794 trials that reported HRQL outcomes across a range of clinical areas, only 56% provided a rationale for the selected outcome measure, 50% provided an HRQL hypothesis, 28% provided information on missing data, and 36% did not discuss the HRQL findings in the context of the other trial outcomes (Brundage et al. Quality of Life Research 20; 653-64). The assessment of HRQL in clinical trials takes valuable patient time and is costly. Poor quality reporting, which may limit the use of such data in clinical practice or to inform health policy, may be viewed as unethical and wasteful of limited resources.
In recognition of the need for improved reporting we are currently developing a new official CONSORT extension. This will provide guidance for editors, reviewers, and authors on standards for HRQL reporting from trial publications. Improved reporting of HRQL in clinical trials will enable robust evidence to inform patient choice, aid clinical decision making, and inform health policy.
The development of the CONSORT extension is the result of collaboration between the International Society for Quality of Life Research (ISOQOL) (led by Professor Michael Brundage), the CONSORT Executive (Professors Moher and Altman), the MRC Midland Hub for Trials Methodology Research (Dr Melanie Calvert) and the MRC ConDuCT Hub for Trials Methodology Research (Professor Jane Blazeby) working closely with leading international journal editors, policy makers and patient representatives.
Prior to the Consensus meeting, which will be held in London in January 2012, the group is undertaking a modified Delphi exercise to elicit stakeholder views. We invite BMJ readers to contribute to this initiative through completion of the survey using the following link: https://www.surveymonkey.com/s/DWLNZ7V. Please watch out for further updates.
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Melanie Calvert, Jane Blazeby, Dennis Revicki, David Moher, Michael Brundage.
Melanie Calvert is a member of the ISOQOL Reporting Guidelines Task Force and MRC Midland Hub for Trials Methodology Research
This study is supported by the Medical Research Council, UK and the Canadian Institute for Health Research. Dr. Moher is funded, in part, through a University of Ottawa Research Chair.