Is Total Hip Arthroplasty a Cost-Effective Option for Management of Displaced Femoral Neck Fractures? A Trial-Based Analysis of the HEALTH Study

BACKGROUND: Displaced femoral neck fractures are a significant source of morbidity and mortality and can be treated with either hemiarthroplasty (HA) or total hip arthroplasty (THA). Proponents of THA have argued THA offers lower risk of revision, with improved functional outcomes when compared to HA. To evaluate cost effectiveness of THA compared with HA, a trial-based economic analysis of the HEALTH study was undertaken. METHODS: Health care resource utilization (HRU) and health-related quality of life (HRQoL) data were collected postoperatively and costed using publicly available databases. Using EuroQol-5 Dimensions (EQ-5D) scores, we derived quality adjusted life years (QALYs). A 1.5% discount rate to both costs and QALYs was applied. Age analyses per age group were conducted. All costs are reported in 2019 Canadian dollars. RESULTS: When compared with HA, THA was not cost-effective for all patients with displaced femoral neck fractures ($150,000/QALY gained). If decision makers were willing to spend$50,000 or $100,000 to gain one QALY, the probability of THA being cost-effective was 12.8% and 32.8%, respectively. In a subgroup of patients younger than 73 (first quartile), THA was both more effective and less costly. Otherwise, THA was more expensive and yielded marginal HRQoL gains. CONCLUSIONS: Our results suggest that for most patients, THA is not a cost-effective treatment for displaced femoral neck fracture management versus HA. However, THA may be cost effective for younger patients. These patients experience more meaningful improvements in quality of life with less associated cost because of shorter hospital stay and fewer postoperative complications. LEVEL OF EVIDENCE: Economic Level II. See Instructions for Authors for a complete description of levels of evidence

Correction to: Cluster identification, selection, and description in Cluster randomized crossover trials: the PREP-IT trials

An amendment to this paper has been published and can be accessed via the original article

Viscosupplementation in knee osteoarthritis: Evidence revisited

COPYRIGHT © 2016 BY THE JOURNAL OF BONE AND JOINT SURGERY, INCORPORATED. The body of evidence surrounding the use of viscosupplementation in knee osteoarthritis is extensive and fraught with heterogeneous trials with conflicting conclusions.Attempts to aggregate the evidence through systematic reviews, meta-analyses, and guidelines have also resulted in unclear, discordant recommendations. Closer examination reveals that the evidence around viscosupplementation favors clinically important reductions in pain among higher-molecular-weight and cross-linked formulations and is a safe option in patients with knee osteoarthritis.Further large trials assessing the use of viscosupplementation across various formulations in knee osteoarthritis may confirm subgroup findings from meta-analyses; however, immediate focus on improved knowledge translation is required to ensure evidence-based approaches to the treatment of knee osteoarthritis

Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial

Background Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a centralised computer system to receive a single large-diameter screw with a side-plate (sliding hip screw) or the present standard of care, multiple small-diameter cancellous screws. Surgeons and patients were not blinded but the data analyst, while doing the analyses, remained blinded to treatment groups. The primary outcome was hip reoperation within 24 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Analyses followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT00761813. Findings Between Mar

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

Introduction: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. Methods: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. Results: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. Discussion: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal