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 Cochrane 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 (QoL) 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 (RCTs) 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 Cochrane database of systematic reviews that evaluated the effects of ventilation tube insertion, adenoidectomy, tonsillectomy and endoscopic sinus surgery was assessed. The RCTs 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 Cochrane 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 QoL 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 RCTs relevant to this review. Five (55%) and three (30%) of the ongoing RCTs in ClinicalTrial.gov assess PROM and QoL topics in ENT surgery, respectively. Conclusions Since the introduction of QoL instruments in the 1990s, their use has gradually increased, but validated QoL instruments have been used in only one of 10 RCTs included in EBM databases. Ongoing RCTs consider QoL only slightly more often.