The effectiveness and cost-effectiveness of minimal access surgery amongst people with gastro-oesophageal reflux disease – a UK collaborative study. The REFLUX trial

• DOI: 10.3310/hta12310
• Publication Date: 2014-10-13T11:53:29Z
• Authors: A Grant; S Wileman; C Ramsay; L Bojke; D Epstein; M Sculpher; S Macran; M Kilonzo; L Vale; J Francis; A Mowat; Z Krukowski; R Heading; M Thursz; I Russell; M Campbell
• Keywords: Adult; Male; Technology Assessment, Biomedical; Cost-Benefit Analysis; 610; Fundoplication; 03 medical and health sciences; 0302 clinical medicine; Gastrointestinal Agents; Surveys and Questionnaires; 617; Medical technology; Humans; Minimally Invasive Surgical Procedures; R855-855.5; Middle Aged; 16. Peace & justice; 3. Good health; Treatment Outcome; Gastroesophageal Reflux; Quality of Life; Health Resources; Female; Laparoscopy; Quality-Adjusted Life Years; Factor Analysis, Statistical; Models, Econometric

To evaluate the clinical effectiveness, cost-effectiveness and safety of a policy relatively early laparoscopic surgery compared with continued medical management amongst people gastro-oesophageal reflux disease (GORD) judged suitable for both policies.Relative effectiveness was assessed by randomised trial (with parallel non-randomised preference groups) comparing surgery-based policy. The economic evaluation two policies in order to identify most efficient provision future care describe resource impact that various fundoplication would have on NHS.A total 21 hospitals throughout UK local partnership between surgeon(s) gastroenterologist(s) who shared secondary patients GORD.The 810 participants, were identified retrospectively or prospectively via their participating clinicians, had documented evidence GORD (endoscopy and/or manometry/24-hour pH monitoring) symptoms longer than 12 months. In addition, recruiting clinician(s) clinically uncertain about which best.Of eligible consented participate, 357 recruited arm (178 allocated surgical management, 179 continued, but optimised, management) 453 (261 chose 192 continue best management). type left discretion surgeon.Participants completed baseline REFLUX questionnaire, developed specifically this study, containing disease-specific outcome measure, Short Form 36 Items (SF-36), EuroQol-5 Dimensions (EQ-5D) Beliefs Medicines Surgery questionnaires (BMQ/BSQ). Postal at participant-specific time intervals after joining (equivalent approximately 3 months surgery). Intraoperative data recorded surgeons all other in-hospital collected research nurse. At end study period, participants discrete choice experiment questionnaire.The groups well balanced entry. Participants been taking medication median 32 months; mean age 46 years 66% men. Of 178 surgery, 111 (62%) actually fundoplication. There mixture personal reasons why some did not sometimes related long waiting times. A partial wrap procedure performed depending surgeon preference. Complications uncommon there no deaths associated surgery. By equivalent 38% group (14% those surgery) 90% group. substantial differences (one-third one-half standard deviation) favouring across health status measures, size assumptions proportion These same somewhat smaller observed lower score, worse entry larger benefit lowest scores baseline. improved substantially they better BMQ/BSQ distinguish from each groups. latter indicated risk serious complications important single attribute treatment option. within-trial analysis suggested more costly (mean 2049 pounds) also effective [+0.088 quality-adjusted life-years (QALYs)]. estimated incremental cost per QALY 19,000-23,000 pounds, probability 46% (when 62% received 19% threshold 20,000 pounds QALY. Modelling plausible longer-term scenarios (such as lifetime greater likelihood (74%) applying range alternative wide uncertainty. expected value perfect information greatest quality life proportions requiring medication.Amongst long-term control GORD, significantly increases general reflux-specific health-related least up rare. is, however, management. it may be cost-effective, especially when putative benefits are taken into account, is uncertain. troublesome symptoms, potential Uncertainty greatly reduced reliable relative costs policies. This could through extended follow-up cohorts patients.Current Controlled Trials ISRCTN15517081.