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. 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.Aims
Methods
This trial aims to assess the effectiveness of quality improvement collaboratives as a technique to introduce large-scale change and improve outcomes for patients undergoing primary elective total hip or total knee arthroplasty. 41 NHS Trusts that did not have; a preoperative anaemia screening and optimisation pathways, or a methicillin sensitive Staphylococcus Aureus (MSSA) decolonisation pathway, in place were randomised to one of two parallel collaboratives in a two arm, cluster randomised controlled trial. Each collaborative focussed on implementing one of these two preoperative pathways. Collaboratives took place from May 2018 to November 2019. 27 Trusts completed the trial. Outcome data were collected for procedures between November 2018 and November 2019. Co-primary outcomes were perioperative blood transfusion (within 7 days of surgery) and deep surgical site infections (SSI) caused by MSSA (within 90 days) for the anaemia and MSSA arms respectively. Secondary outcomes include deep and superficial SSIs (any organism), length of stay, critical care admissions, and readmissions. Process measures include the proportion of patients receiving each preoperative initiative. 19,254 procedures from 27 Trusts are included. Process measures show both preoperative pathways were implemented to a high degree (75.3% compliance in MSSA arm; 61.2% anaemia arm), indicating that QICs can facilitate change in the NHS. However, there were no improvements in blood transfusions (2.9% v 2.3% adjusted-OR 1.20, 95% CI 0.52–2.75, p=0.67), MSSA deep SSIs (0.13% v 0.14% adjusted-OR 1.01, 95%CI 0.42–2.46, p=0.98), or any secondary outcome. Whilst no significant improvement in patient outcomes were seen, this trial shows quality improvement collaboratives can successfully support the implementation of new preoperative pathways in planned surgery in the NHS.
A pragmatic multicentre randomized controlled trial, UK FROzen Shoulder Trial (UK FROST), was conducted in the UK NHS comparing the cost-effectiveness of commonly used treatments for adults with primary frozen shoulder in secondary care. A cost utility analysis from the NHS perspective was performed. Differences between manipulation under anaesthesia (MUA), arthroscopic capsular release (ACR), and early structured physiotherapy plus steroid injection (ESP) in costs (2018 GBP price base) and quality adjusted life years (QALYs) at one year were used to estimate the cost-effectiveness of the treatments using regression methods.Aims
Methods
A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients’ quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures. A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods.Aims
Methods
Smaller studies indicate that yoga may be an effective treatment for chronic low back pain. We conducted a randomised trial to evaluate if yoga compared to usual care improves back function in patients with chronic or recurrent low back pain. Outcomes were assessed by postal questionnaires. The setting was 13 non-National Health Service premises. We recruited 313 adults with chronic or recurrent low back pain from primary care. 157 were randomised to usual care. 156 were randomised to a 12-class, gradually-progressing programme of yoga delivered by 12 teachers over three months. All received The Back Book. Primary outcome was back function (Roland Morris Disability Score) at three months. Secondary outcomes: back function at six and 12 months, back pain, pain self-efficacy and general health. Back function improved more in the yoga group: mean difference in changes from baseline at three (−2.17, 95% CI −3.31 to −1.03, p<0.001), six (−1.48, 95% CI −2.62 to −0.33, p=0.011) and 12 months (−1.57, −2.71 to −0.42, p=0.007). Improvement in pain self-efficacy at three and six months in the yoga group. No differences in general health and pain reduction. Two adverse events were reported by controls and 12 by the yoga group – 8 out of 12 reported pain which may have been due to yoga. 63 (40%) were not fully compliant with treatment and 23 (15%) did not attend any yoga classes.Purposes of the study and background
Summary of the methods used and the results
