Evaluation of a shared decision-making strategy with online decision aids in surgical and orthopaedic practice: study protocol for the E-valuAID, a multicentre study with a stepped-wedge design.

BACKGROUND: Inguinal hernia repair, gallbladder removal, and knee- and hip replacements are the most commonly performed surgical procedures, but all are subject to practice variation and variable patient-reported outcomes. Shared decision-making (SDM) has the potential to reduce surgery rates and increase patient satisfaction. This study aims to evaluate the effectiveness of an SDM strategy with online decision aids for surgical and orthopaedic practice in terms of impact on surgery rates, patient-reported outcomes, and cost-effectiveness. METHODS: The E-valuAID-study is designed as a multicentre, non-randomized stepped-wedge study in patients with an inguinal hernia, gallstones, knee or hip osteoarthritis in six surgical and six orthopaedic departments. The primary outcome is the surgery rate before and after implementation of the SDM strategy. Secondary outcomes are patient-reported outcomes and cost-effectiveness. Patients in the usual care cluster prior to implementation of the SDM strategy will be treated in accordance with the best available clinical evidence, physician's knowledge and preference and the patient's preference. The intervention consists of the implementation of the SDM strategy and provision of disease-specific online decision aids. Decision aids will be provided to the patients before the consultation in which treatment decision is made. During this consultation, treatment preferences are discussed, and the final treatment decision is confirmed. Surgery rates will be extracted from hospital files. Secondary outcomes will be evaluated using questionnaires, at baseline, 3 and 6 months. DISCUSSION: The E-valuAID-study will examine the cost-effectiveness of an SDM strategy with online decision aids in patients with an inguinal hernia, gallstones, knee or hip osteoarthritis. This study will show whether decision aids reduce operation rates while improving patient-reported outcomes. We hypothesize that the SDM strategy will lead to lower surgery rates, better patient-reported outcomes, and be cost-effective. TRIAL REGISTRATION: The Netherlands Trial Register, Trial NL8318, registered 22 January 2020. URL: https://www.trialregister.nl/trial/8318 .

Unsatisfactory results with the cementless Omnifit acetabular component due to polyethylene and severe osteolysis.

A high incidence of acetabular osteolysis (43%), associated with osteolytic lesions in the proximal femur (22.6%) and leading to a high revision rate, was experienced with the Omnifit total hip prosthesis. We reviewed the clinical and radiological results with 429 Omnifit total hips in 356 patients after a mean follow-up of 60 months. Time to revision and wear of the polyethylene liner with different acetabular shell types were specifically analysed. Pelvic osteolysis first became manifest in the acetabular bone opposite to the holes in the metal shell. Osteolysis occurred predominantly adjacent to the central hole in the metal shell of threaded cups; widespread and larger defects were found in press fit cups with peripheral screw holes. Kaplan Meier survival analysis demonstrated a higher probability for retaining the threaded cup at 6 years (96%; 95%-confidence interval: 93-99%) compared to the survival of the press fit cup (66%; 95%-CI: 56-77%). The results suggest a negative relationship between backside wear, the larger number of holes in the cup, the extent of osteolysis and survival rate of the press fit cups. Based on these findings and supported by similar reports about osteolysis related to the same cup design, it was hypothesised that backside wear due to the insufficient locking mechanism of the Omnifit acetabular cup was the major cause of the unsatisfactory results in our patients. For this reason we discontinued using this type of uncemented socket.