• Prita Daliya, Elizabeth H Gemmill, Dileep N Lobo, and Simon L Parsons.
• Gastrointestinal Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen's Medical Centre, Nottingham NG7 2UH, UK.
• Hepatobiliary Surg Nutr. 2019 Jun 1; 8 (3): 228-245.

AbstractPatient reported outcome measures (PROMs) provide a valuable means of measuring outcomes subjectively from a patient's perspective, facilitating the assessment of service quality across healthcare providers, and assisting patients and clinicians in shared decision making. The primary aim of this systematic review was to critically appraise all historic studies evaluating patient reported quality of life, in adult patients undergoing laparoscopic cholecystectomy for symptomatic gallstones. The secondary aim was to perform a quality assessment of cholecystectomy-specific PROM-validation studies. A literature review was performed in PubMed, Google ScholarTM, the Cochrane Library, Medline, CINAHL, EMBASE and PsychINFO databases up to September 2017. Study characteristics, PROM-specific details and a bias assessment were summarised for non-validation studies. A COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) analysis was performed to assess the methodological quality of identified PROM-validation studies. Fifty one studies were found to evaluate health-related quality of life (HRQoL) after laparoscopic cholecystectomy. Although 94.1% of these studies included PROMs as a primary outcome measure, <20% provided level 1 evidence through randomised controlled trials (RCTs). There was significant variation in the selection and reporting of PROMs, with no studies declaring patient involvement in PROM selection, and 88.2% of studies failing to document the management of missing data points, or non-returned surveys (33.3%). In the 6 PROM-validation studies identified, only 5 psychometric properties were evaluated, the findings of which were limited due to the small number of studies. This systematic review identifies a lack in consistency of study design and PRO reporting in clinical trials. Whilst an increasing number of studies are being performed to evaluate PROs, a lack of adherence to existing PRO administration and reporting guidelines is continuing to negatively affect study quality. We recommend that future clinical trials utilizing PROs should adhere to established comprehensive guidelines as described.

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