Consistency of patient-reported outcomes after cholecystectomy and their implications on current surgical practice: a prospective multicenter cohort study

Abstract

BackgroundPersistent postoperative pain (up to 41 %) and significant practice variation necessitate better patient selection for cholecystectomy. Patient-reported outcome measures (PROMs) are nowadays known to serve as a tool for better patient selection, although variability within these subjective outcomes may be a point for debate. This study determines associations of both the preoperative pain and patient characteristics with PROMs at 24 weeks after cholecystectomy. In order to evaluate variability of PROMs, we also determined consistency of these outcomes in time.MethodsThis prospective multicenter cohort study included adult patients diagnosed with uncomplicated symptomatic cholecystolithiasis. Twenty-four weeks after surgery, a questionnaire study was carried out, containing Gastrointestinal Quality of Life Index (GIQLI) and Patients’ Experience of Surgery Questionnaire. Results were compared to preoperative data and results 12 weeks post-cholecystectomy. Logistic regression analyses were performed to determine associations. Additional post hoc analysis on associations between preoperative selection criteria and PROMs was done.ResultsA total of 360 patients (85 %) responded. Postoperative absence of pain was reported by 59.2 %. Associated characteristics were symptoms ≤1 year prior to surgery [OR 1.85 (95 % CI 1.11–3.09)] and high baseline GIQLI score [OR 1.04 (95 % CI 1.02–1.05)]. General improvement in abdominal symptoms and positive result of surgery were found in 90 %; no preoperative variables were significantly associated. PROMs showed consistency at 12 and 24 weeks postoperatively. Post hoc analysis showed no significant associations.ConclusionPROM-based preoperative selection criteria need to be considered to select those patients who achieve freedom of pain after surgical treatment of uncomplicated symptomatic cholecystolithiasis. Other patients might consider cholecystectomy as successful, but are less likely to be free of pain. Usefulness of PROMs is underscored as they proved to be consistent in time in evaluating surgical outcome.

Patient-Reported Outcomes in Patients with Chronic Kidney Disease and Kidney Transplant—Part 1

“…Subsequently, several studies have suggested that PREMs have limited utility as a marker of quality of care, with PREMs being shown to have little to no association with quality of care or clinical outcomes ( 35 , 118 , 120 , 121 ). PROMs, on the other hand, have demonstrated significant association with clinical outcomes ( 12 , 14 , 103 , 104 , 122 ).…”

Statistical analysis plan of a randomized controlled trial to compare a restrictive strategy to usual care for the effectiveness of cholecystectomy (SECURE trial)

“…Laparoscopic cholecystectomy is the treatment of choice to relieve symptoms, mainly abdominal pain. However, up to 40% of patients report persistent pain after surgery [ 1 , 2 ]. Annually, approximately 24,000 laparoscopic cholecystectomies are performed in the Netherlands [ 12 ] and 700,000 in the USA [ 13 ].…”

“…Despite the high number of cholecystectomies for symptomatic cholecystolithiasis performed worldwide, this approach appears to be ineffective as up to 40% of patients will continue to have (persistent) abdominal pain [ 1 , 2 ]. The SECURE trial is designed to examine the effectiveness of usual care versus restrictive strategy in patients with symptomatic gallstones.…”

Patient reported outcomes in elective laparoscopic cholecystectomy

“…Various studies have used different outcome measurements after LC, such as the Surgical Outcomes Measurement System,6 Gastrointestinal Quality of Life Index (GIQLI),789 Patients' Experience of Surgery Questionnaire (PESQ),10 EuroQol-5D (EQ-5D) and condition-specific questionnaires 11. These studies highlighted the usefulness of patient-reported outcome measures (PROM) as significant determinants of patient satisfaction following cholecystectomy.…”