Reporting on quality of life in randomised controlled trials in gastrointestinal surgery.
BACKGROUND
Although health-related quality of life (HRQOL) has become an important outcome measure in surgical trials, questions still remain about the quality of its reporting. The aim of this study was to evaluate HRQOL assessment methodology of randomised clinical trials concerning gastrointestinal surgery.


METHODS
All articles published in the calendar years 2006 and 2007 that purported to assess quality of life as end points or make some conclusion about quality of life were chosen for review from eight general surgical journals and four medical journals. Identified eligible studies were selected and then evaluated on a broad set of predetermined criteria.


RESULTS
Twenty-four published randomised controlled clinical trials (RCTs)s with an HRQOL component were identified. Although most trials exhibited good-quality research, some methodological limitations were identified: Only 21% of the studies gave a rationale for selecting a specific HRQOL measure, 46% of the studies failed to report information about the administration of the HRQOL measure, and 37% did not give details on missing data.


CONCLUSIONS
Although it is clear that HRQOL is an important end point in surgical RCTs because the information helps to influence treatment recommendations, a number of methodological shortcomings have to be further addressed in future studies.
Bridoux
Valerie
V
Department of Digestive Surgery, Rouen University Hospital, 76031 Rouen Cedex, France.
Moutel
Grégoire
G
Lefebure
Benoit
B
Scotte
Michel
M
Michot
Francis
F
Herve
Christian
C
Tuech
Jean-Jacques
JJ
D013505:Digestive System Surgical Procedures; D006304:Health Status; D006801:Humans; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000592:standards*