Outcomes
death, dyspepsia, pain, bodily pain, gallstone disease
ADVERSE EVENTS, ADVERSE EVENT, COMPLICATION, SECONDARY, GALLSTONE DISEASE, COMPLICATIONS
Measurements were taken from participants’ questionnaires at baseline and at 3, 9, 12, and 18 months. The primary outcome was the area under the curve up to 18 months post-randomisation using the short form, SF-36, bodily pain domain (norm based score transformed to align with a general population with a mean of 50 and a standard deviation of 10). Area under the curve was chosen to incorporate the total quality of life of participants throughout the trial. The patient reported secondary outcomes were area under the curve up to 24 months post-randomisation for the SF-36 bodily pain domain, condition specific questionnaire, SF-36 domains (excluding bodily pain), need for further treatment, and persistent symptoms (consisting of two sections (pain and dyspepsia) of the condition specific questionnaire) at 18 months and 24 months after randomisation. The clinical secondary outcome was complications, defined as any complication before, during, or after surgery at 18 months and 24 months after randomisation. Adverse events, serious adverse events, and death were also recorded. Economic outcomes included UK NHS resource use and costs, QALYs obtained with the responses to the SF-36 instrument,Data on NHS hospital inpatient resource use were obtained through hospital case report forms. Data on primary care contacts, secondary outpatient care, and drugs for symptomatic gallstone disease or post-surgery were acquired using participants’ questionnaires at 3, 9, 12, 18, and 24 months post-randomisation. Data on resource use were combined with data on national unit costs for the financial year 2019/20