Patient‐recorded outcomes and quality of life in evidence‐based medicine databases on most common ear, throat and nose procedures: a systematic review

Background The C ochrane database of systematic reviews is an evidence‐based medicine ( EBM ) database that provides the highest quality evidence of the effect of various treatments. Quality of life ( Q o L ) is an important aspect when treatment effect is considered. Objective To assess how often patient‐reported outcome measures ( PROM ), and specifically the quality of life aspect, were evaluated in the randomised controlled trial projects ( RCT s) included in the Cochrane database of systematic reviews of the most common ear, throat and nose operations. Also, to explore the same in ongoing trials registered in ClinicalTrials.gov . Methods Structured literature search. Search strategy and evaluation method The C ochrane database of systematic reviews that evaluated the effects of ventilation tube insertion, adenoidectomy, tonsillectomy and endoscopic sinus surgery was assessed. The RCT s on which the reviews' conclusions were based were explored, and the outcome variables were recorded. A similar search was carried out in the ClinicalTrials.gov trial register. Results In the C ochrane database, we identified seven systematic reviews with 30 RCT projects. Fourteen (49%) collected some sort of PROM and of those, three (10%) used a validated Q o L instrument. After the year 2000, the respective figures were 12 of 15 (80%) and 3 of 15 (20%). In ClinicalTrials.gov , we found 500 ongoing studies on the most common ENT operations, nine being RCT s relevant to this review. Five (55%) and three (30%) of the ongoing RCT s in ClinicalTrial.gov assess PROM and Q o L topics in ENT surgery, respectively. Conclusions Since the introduction of Q o L instruments in the 1990s, their use has gradually increased, but validated Q o L instruments have been used in only one of 10 RCT s included in EBM databases. Ongoing RCT s consider Q o L only slightly more often.