REPORTING ON QUALITY-OF-LIFE IN RANDOMIZED CONTROLLED TRIALS - BIBLIOGRAPHIC STUDY

Objectives To examine the frequency and quality of reporting on qualit y of life in randomised controlled trials. Design Search of the Cochra ne Controlled Trials Register 1980 to 1997 to identify trials from all disciplines, from oncology, and from cardiovascular medicine that rep orted on quality of life. Assessment of abstracts from articles publis hed from 1993 to 1996. Assessment of a sample of full reports with a s tandardised instrument. Main outcome measures Prevalence of reporting on quality of life. Conditions and interventions studied in trials rep orting on quality of life. Quality of reporting on quality of life. Re sults During 1980-97 reporting on quality of life increased from 0.63% to 4.2% for trials from all disciplines, from 1.5% to 8.2% for cancer trials, and from 0.34% to 3.6% for cardiovascular trials. Of 364 abst racts, 65% reported on drug interventions. Of a sample of 61 full repo rts, authors of 48 (72%) used 62 established quality of life instrumen ts. In 15 reports (22%) authors developed their own measures, and in 2 (3%) methods were unclear Response rates were given in 38 (57%), and complete reporting on all items and scales occurred in 31 (46%). Concl usions Less than 5% of all randomised controlled trials reported on qu ality of life, and this proportion was below 10% even for cancer trial s. A plethora of instruments was used in different studies, and the re porting of methods and results was often inadequate. Standards for the measurement and reporting of quality of life in clinical trials resea rch need to be developed.