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Bone & Joint Open
Vol. 4, Issue 2 | Pages 96 - 103
14 Feb 2023
Knowlson CN Brealey S Keding A Torgerson D Rangan A

Aims. Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this. Methods. Included RCTs were ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation), a two-arm study of surgery versus non-surgical treatment for proximal humerus fractures, and UK FROST (United Kingdom Frozen Shoulder Trial), a three-arm study of two surgical and one non-surgical treatment for frozen shoulder. To determine whether early treatment effects were present, the primary outcome of Oxford Shoulder Score (OSS) was compared on forest plots for: the chief investigator’s (CI) site to the remaining sites, the first five sites opened to the other sites, and patients grouped in quintiles by randomization date. Potential for bias was assessed by comparing mean age and proportion of patients with indicators of poor outcome between included and excluded/non-consenting participants. Results. No bias in treatment effect was observed overall for the CI site, or the first five sites, compared with the remaining sites in either trial. An early treatment effect on the OSS was observed for the first quintile of participants recruited to ProFHER only (clinically relevant difference of seven points). Selection bias for age was observed in the ProFHER trial only, with slightly younger patients being recruited into the study. Both trials showed some selection bias for markers of poor prognosis, although these did not appear to change over time. Conclusion. No bias in treatment effects overall were found at the CI or early sites set-up. An early treatment effect was found in one of the two trials, which was likely a chance effect as this did not continue during the study. Selection bias was observed in both RCTs, however this was minimal and did not impact on outcome. Cite this article: Bone Jt Open 2023;4(2):96–103


Bone & Joint Open
Vol. 2, Issue 2 | Pages 134 - 140
24 Feb 2021
Logishetty K Edwards TC Subbiah Ponniah H Ahmed M Liddle AD Cobb J Clark C

Aims

Restarting planned surgery during the COVID-19 pandemic is a clinical and societal priority, but it is unknown whether it can be done safely and include high-risk or complex cases. We developed a Surgical Prioritization and Allocation Guide (SPAG). Here, we validate its effectiveness and safety in COVID-free sites.

Methods

A multidisciplinary surgical prioritization committee developed the SPAG, incorporating procedural urgency, shared decision-making, patient safety, and biopsychosocial factors; and applied it to 1,142 adult patients awaiting orthopaedic surgery. Patients were stratified into four priority groups and underwent surgery at three COVID-free sites, including one with access to a high dependency unit (HDU) or intensive care unit (ICU) and specialist resources. Safety was assessed by the number of patients requiring inpatient postoperative HDU/ICU admission, contracting COVID-19 within 14 days postoperatively, and mortality within 30 days postoperatively.