Group sequential designs for pragmatic clinical trials with early outcomes: methods and guidance for planning and implementation.

BACKGROUND: Group sequential designs are one of the most widely used methodologies for adaptive design in randomized clinical trials. In settings where early outcomes are available, they offer large gains in efficiency compared to a fixed design. However, such designs are underused and used predominantly in therapeutic areas where there is expertise and experience in implementation. One barrier to their greater use is the requirement to undertake simulation studies at the planning stage that require considerable knowledge, coding experience and additional costs. Based on some modest assumptions about the likely patterns of recruitment and the covariance structure of the outcomes, some simple analytic expressions are presented that negate the need to undertake simulations. METHODS: A model for longitudinal outcomes with an assumed approximate multivariate normal distribution and three contrasting simple recruitment models are described, based on fixed, increasing and decreasing rates. For assumed uniform and exponential correlation models, analytic expressions for the variance of the treatment effect and the effects of the early outcomes on reducing this variance at the primary outcome time-point are presented. Expressions for the minimum and maximum values show how the correlations and timing of the early outcomes affect design efficiency. RESULTS: Simulations showed how patterns of information accrual varied between correlation and recruitment models, and consequentially to some general guidance for planning a trial. Using a previously reported group sequential trial as an exemplar, it is shown how the analytic expressions given here could have been used as a quick and flexible planning tool, avoiding the need for extensive simulation studies based on individual participant data. CONCLUSIONS: The analytic expressions described can be routinely used at the planning stage of a putative trial, based on some modest assumptions about the likely number of outcomes and when they might occur and the expected recruitment patterns. Numerical simulations showed that these models behaved sensibly and allowed a range of design options to be explored in a way that would have been difficult and time-consuming if the previously described method of simulating individual trial participant data had been used.

Can ChatGPT assist authors with abstract writing in medical journals? Evaluating the quality of scientific abstracts generated by ChatGPT and original abstracts.

INTRODUCTION: ChatGPT, a sophisticated large language model (LLM), has garnered widespread attention for its ability to mimic human-like communication. As recent studies indicate a potential supportive role of ChatGPT in academic writing, we assessed the LLM's capacity to generate accurate and comprehensive scientific abstracts from published Randomised Controlled Trial (RCT) data, focusing on the adherence to the Consolidated Standards of Reporting Trials for Abstracts (CONSORT-A) statement, in comparison to the original authors' abstracts. METHODOLOGY: RCTs, identified in a PubMed/MEDLINE search post-September 2021 across various medical disciplines, were subjected to abstract generation via ChatGPT versions 3.5 and 4, following the guidelines of the respective journals. The overall quality score (OQS) of each abstract was determined by the total number of adequately reported components from the 18-item CONSORT-A checklist. Additional outcome measures included percent adherence to each CONOSORT-A item, readability, hallucination rate, and regression analysis of reporting quality determinants. RESULTS: Original abstracts achieved a mean OQS of 11.89 (95% CI: 11.23-12.54), outperforming GPT 3.5 (7.89; 95% CI: 7.32-8.46) and GPT 4 (5.18; 95% CI: 4.64-5.71). Compared to GPT 3.5 and 4 outputs, original abstracts were more adherent with 10 and 14 CONSORT-A items, respectively. In blind assessments, GPT 3.5-generated abstracts were deemed most readable in 62.22% of cases which was significantly greater than the original (31.11%; P = 0.003) and GPT 4-generated (6.67%; P<0.001) abstracts. Moreover, ChatGPT 3.5 exhibited a hallucination rate of 0.03 items per abstract compared to 1.13 by GPT 4. No determinants for improved reporting quality were identified for GPT-generated abstracts. CONCLUSIONS: While ChatGPT could generate more readable abstracts, their overall quality was inferior to the original abstracts. Yet, its proficiency to concisely relay key information with minimal error holds promise for medical research and warrants further investigations to fully ascertain the LLM's applicability in this domain.

Health Outcomes Following Engagement With a Digital Health Tool Among People With Prediabetes and Type 2 Diabetes: Prospective Evaluation Study.

BACKGROUND: Diabetes is a worldwide chronic condition causing morbidity and mortality, with a growing economic burden on health care systems. Complications from poorly controlled diabetes are associated with increased socioeconomic costs and reduced quality of life. Smartphones have become an influential platform, providing feasible tools such as health apps to deliver tailored support to enhance the ability of patients with diabetes for self-management. Gro Health is a National Health Service division X-certified digital health tool used to deliver educational and monitoring support to facilitate the development of skills and practices for maintaining good health. OBJECTIVE: This study aims to assess self-reported outcomes of the Gro Health app among users with diabetes and prediabetes and identify the factors that determine engagement with the digital health tool. METHODS: This was a service evaluation of self-reported data collected prospectively by the developers of the Gro Health app. The EQ-5D questionnaire is a standardized tool used to measure health status for clinical and economic appraisal. Gro Health users completed the EQ-5D at baseline and 6 months after using the app. Users provided informed consent for the use of their anonymized data for research purposes. EQ-5D index scores and visual analogue scale (VAS) scores were calculated at baseline and 6 months for individuals with prediabetes and type 2 diabetes. Descriptive statistics and multiple-regression models were used to assess changes in the outcome measures and determine factors that affected engagement with the digital tool. RESULTS: A total of 84% (1767/2114) of Gro Health participants completed EQ-5D at baseline and 6 months. EQ-5D index scores are average values that reflect people's preferences about their health state (1=full health and 0=moribund). There was a significant and clinically meaningful increase in mean EQ-5D index scores among app users between baseline (0.746, SD 0.23) and follow-up (0.792, SD 0.22; P<.001). The greatest change was observed in the mean VAS score, with a percentage change of 18.3% improvement (61.7, SD 18.1 at baseline; 73.0, SD 18.8 at follow-up; P<.001). Baseline EQ-5D index scores, age, and completion of educational modules were associated with significant changes in the follow-up EQ-5D index scores, with baseline EQ-5D index scores, race and ethnicity, and completion of educational modules being significantly associated with app engagement (P<.001). CONCLUSIONS: This study provides evidence of a significant positive effect on self-reported quality of life among people living with type 2 diabetes engaging with a digital health intervention. The improvements, as demonstrated by the EQ-5D questionnaire, are facilitated through access to education and monitoring support tools within the app. This provides an opportunity for health care professionals to incorporate National Health Service-certified digital tools, such as Gro Health, as part of the holistic management of people living with diabetes.

Five-year outcomes for patients with a displaced fracture of the distal tibia.

Aims: To report the outcomes of patients with a fracture of the distal tibia who were treated with intramedullary nail versus locking plate in the five years after participating in the Fixation of Distal Tibia fracture (FixDT) trial. Methods: The FixDT trial reported the results for 321 patients randomized to nail or locking plate fixation in the first 12 months after their injury. In this follow-up study, we report the results of 170 of the original participants who agreed to be followed up until five years. Participants reported their Disability Rating Index (DRI) and health-related quality of life (EuroQol five-dimension three-level questionnaire) annually by self-reported questionnaire. Further surgical interventions related to the fracture were also recorded. Results: There was no evidence of a difference in patient-reported disability, health-related quality of life, or the need for further surgery between participants treated with either type of fixation at five years. Considering the combined results for all participants, there was no significant change in DRI scores after the first 12 months of follow-up (difference between 12 and 24 months, 3.3 (95% confidence interval -1.8 to 8.5); p = 0.203), with patients reporting around 20% disability at five years. Conclusion: This study shows that the moderate levels of disability and reduced quality of life reported by participants 12 months after a fracture of the distal tibia persist in the medium term, with little evidence of improvement after the first year.

Use of cast immobilization versus removable brace in adults with an ankle fracture: two-year follow-up of a multicentre randomized controlled trial.

The aim of this study was to compare the longer-term outcomes of operatively and nonoperatively managed patients treated with a removable brace (fixed-angle removable orthosis) or a plaster cast immobilization for an acute ankle fracture. This is a secondary analysis of a multicentre randomized controlled trial comparing adults with an acute ankle fracture, initially managed either by operative or nonoperative care. Patients were randomly allocated to receive either a cast immobilization or a fixed-angle removable orthosis (removable brace). Data were collected on baseline characteristics, ankle function, quality of life, and complications. The Olerud-Molander Ankle Score (OMAS) was the primary outcome which was used to measure the participant's ankle function. The primary endpoint was at 16 weeks, with longer-term follow-up at 24 weeks and two years. Overall, 436 patients (65%) completed the final two-year follow-up. The mean difference in OMAS at two years was -0.3 points favouring the plaster cast (95% confidence interval -3.9 to 3.4), indicating no statistically significant difference between the interventions. There was no evidence of differences in patient quality of life (measured using the EuroQol five-dimension five-level questionnaire) or Disability Rating Index. This study demonstrated that patients treated with a removable brace had similar outcomes to those treated with a plaster cast in the first two years after injury. A removable brace is an effective alternative to traditional immobilization in a plaster cast for patients with an ankle fracture.

Phase 1 safety trial of a natural product cocktail with antibacterial activity in human volunteers.

New antibiotics are urgently needed to reduce the health burden of antibiotic-resistant bacterial infection. Natural products (NPs) derived from plants and animals are a current focus of research seeking to discover new antibacterial molecules with clinical potential. A cocktail of NPs based on a medieval remedy for eye infection eliminated biofilms of several highly antibiotic-resistant bacterial species in laboratory studies, and had a promising safety profile in vitro and in a mouse model. A necessary prelude to refining this remedy into a defined, synthetic mixture suitable for testing with wound infections is to firstly establish safety when applied to healthy human skin. We aimed to assess skin-related outcomes of the preparation in a sample of healthy volunteers. This prospective, single arm, non-randomised Phase I clinical trial consisted of a single patch test intervention with 48-h follow-up. Volunteers were staff, students and members of the public recruited from the University of Warwick and surrounding locality. Adults aged 18-79 years, with no history of severe immunity-related disease, diabetes, recent infection, or known pregnancy were eligible. A 100 µl application of a filter-sterilised NP mixture, comprising ground garlic, onion, white wine and bovine bile, was applied to skin on the upper arm and covered with a dressing. The primary outcome was skin-related adverse events over 48 h. Digital photographs were captured where bothersome, salve-related events were reported. 109 volunteers, aged 18-77 years, were recruited between June and July 2021. Sample mean age was 37.6 (SD 16.1) years, and 63 (58%) participants were female. Outcome data were obtained for 106/109 (97%); two participants were lost to follow-up and one removed the skin patch after nine hours due to a bothersome garlic odour. Twenty-one (19.8%) participants reported any patch-test related sign or symptom; of these 14 (13.2%) participants reported minor events related to the salve, including itchiness, redness, or garlic odour. No serious events were reported. We found no evidence of serious skin-related adverse events related to the NP preparation.Trial registration: International Standard Randomised Controlled Trial Number (ISRCTN10773579). Date registered: 08/01/2021.

The DAPA-DIET study: Metabolic response to Dapagliflozin combined with dietary carbohydrate restriction in patients with Type 2 Diabetes Mellitus and Obesity-A longitudinal cohort study.

OBJECTIVE: The cardio-renal benefits of sodium glucose-like transporter 2 inhibitor (SGLT2i) therapies have been demonstrated in patients with and without type 2 diabetes. However, no studies have explored the long-term metabolic effects of SGLT2i, combined with dietary carbohydrate restriction. Our primary objective was to describe long-term changes in weight, energy expenditure, appetite and body composition after 12 months of Dapagliflozin therapy, with carbohydrate restriction, in people with type 2 diabetes and obesity. Our secondary objective was to assess changes in adiponectin and leptin. METHOD: This was a 12-month cohort study in a secondary care setting. Participants (n = 18) with type 2 diabetes (T2D) and class 3 obesity underwent baseline indirect calorimetry for determination of 24-h energy expenditure, body composition, fasting serum leptin and adiponectin levels, and appetitive assessments. Following initiation of Dapagliflozin (and dietary carbohydrate restriction), measurements were repeated at monthly intervals up to 12 months. RESULTS: Mean starting weight of participants was 129.4 kg (SD 25.9), mean BMI 46.1 kg/m2 (SD 8.3) and mean HbA1c 53.9 mmol/mol (14.1). Seventeen participants completed the study; after 12 months of Dapagliflozin and dietary carbohydrate restriction, mean weight loss was 8.1 kg (SD 11.3 kg; p = .009). This was mediated by reduced fat mass (mean loss, 9.9 kg; SD 10.4 kg; p = .002) associated with reduced serum leptin at 12 months (mean reduction 11,254 pg/ml; SD 16,075; p = .011). There were no significant changes in self-reported appetite, 24-h energy expenditure or serum adiponectin during follow-up. CONCLUSION: In this study, combined Dapagliflozin therapy and carbohydrate restriction in patients with T2D and obesity resulted in a significant reduction of body weight and fat mass at 12 months without any discernible changes in energy expenditure or appetite. These results offer a scientific and clinical rationale to conduct an exploratory trial investigating the effects of a low carbohydrate diet combined with SGLT2 inhibitors in patients with T2D.

Interventions for treating fractures of the distal femur in adults.

BACKGROUND: Fractures of the distal femur (the far end of the thigh bone just above the knee) are a considerable cause of morbidity. Various different surgical and non-surgical treatments have been used in the management of these injuries but the best treatment remains unknown. OBJECTIVES: To evaluate the benefits and harms of interventions for treating fractures of the distal femur in adults. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was October 2021. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials in adults comparing interventions for treating fractures of the distal femur. Interventions included surgical implants (retrograde intramedullary nail (RIMN), fixed-angle devices, non-locking plate fixation, locking plate, internal fixation, distal femoral replacement, mono-axial plates, poly-axial plates and condylar buttress plates) and non-surgical management. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our critical outcomes were validated patient-reported outcome measures (PROMs), direct adverse events, participant-reported quality of life (QoL) and pain scores. Our other important outcomes were adverse events indirectly related to intervention, symptomatic non-union, malunion and resource use. We used GRADE to assess certainty of evidence for each outcome. MAIN RESULTS: We included 14 studies with 753 participants: 13 studies compared different surgical interventions, and one study compared surgical with non-surgical management. Here, we report the effects for RIMN compared with locking plates. Three studies (221 participants) reported this comparison; it included the largest study population and these are the two most commonly used devices in contemporary orthopaedic trauma practice. Studies used three different tools to assess PROMs. We found very-low certainty evidence for lower Disability Rating Index scores after RIMN at short-term follow-up favouring RIMN (mean difference (MD) -21.90, 95% confidence interval (CI) -38.16 to -5.64; 1 study, 12 participants) and low-certainty evidence of little or no difference at long-term follow-up (standardised mean difference (SMD) -0.22, 95% CI -0.50 to 0.06; 2 studies, 198 participants). Re-expressing the SMD of the long-term follow-up data to Knee Society Score (KSS) used by one study found no clinical benefit of RIMN, based on a minimal clinically important difference of 9 points (MD 2.47, 95% CI -6.18 to 0.74). The effect on QoL was very uncertain at four months (MD 0.01, 95% CI -0.42 to 0.44; 1 study, 14 participants) and one year (MD 0.10, 95% CI -0.01 to 0.21; 1 study, 156 participants); this evidence was very low certainty. For direct adverse events, studies reported reoperation, loss of fixation, superficial and deep infection, haematoma formation and implant loosening. Effects for all events were imprecise with the possibility of benefit or harm for both treatments. We considered reoperation the most clinically relevant. There was very low-certainty evidence of little or no difference in reoperation between the two implants (risk ratio (RR) 1.48, 95% CI 0.55 to 4.00; 1 study, 104 participants). No studies reported pain.  For other important outcomes, we noted that people treated with RIMN may be more likely to have varus/valgus deformity (RR 2.18, 95% CI 1.09 to 4.37; 1 study, 33 participants; low-certainty evidence). However, we found no evidence of any important differences between treatments in terms of bony union, indirect adverse events, or resource use. Other comparisons of surgical interventions included in the review were: RIMN versus single fixed-angle device (3 studies, 175 participants); RIMN versus non-locking plate fixation (1 study, 18 participants); locking plate versus single fixed-angle device (2 studies, 130 participants); internal fixation versus distal femoral replacement (1 study, 23 participants); mono-axial plates versus poly-axial plates (2 studies, 67 participants); mono-axial plate versus condylar buttress plate (1 study, 78 participants). The certainty of the evidence for outcomes in these comparisons was low to very low, and most effect estimates were imprecise. AUTHORS' CONCLUSIONS: This review highlights the major limitations of the available evidence concerning current treatment interventions for fractures of the distal femur. The currently available evidence is incomplete and insufficient to inform clinical practice. Priority should be given to randomised controlled trials comparing contemporary treatments for people with fractures of the distal femur. At a minimum, these should report validated patient-reported functional and quality-of-life outcomes at one and two years, with an agreed core outcome set. All trials should be reported in full using the CONSORT guidelines.

Group sequential designs in pragmatic trials: feasibility and assessment of utility using data from a number of recent surgical RCTs.

BACKGROUND: Assessing the long term effects of many surgical interventions tested in pragmatic RCTs may require extended periods of participant follow-up to assess effectiveness and use patient-reported outcomes that require large sample sizes. Consequently the RCTs are often perceived as being expensive and time-consuming, particularly if the results show the test intervention is not effective. Adaptive, and particularly group sequential, designs have great potential to improve the efficiency and cost of testing new and existing surgical interventions. As a means to assess the potential utility of group sequential designs, we re-analyse data from a number of recent high-profile RCTs and assess whether using such a design would have caused the trial to stop early. METHODS: Many pragmatic RCTs monitor participants at a number of occasions (e.g. at 6, 12 and 24 months after surgery) during follow-up as a means to assess recovery and also to keep participants engaged with the trial process. Conventionally one of the outcomes is selected as the primary (final) outcome, for clinical reasons, with others designated as either early or late outcomes. In such settings, novel group sequential designs that use data from not only the final outcome but also from early outcomes at interim analyses can be used to inform stopping decisions. We describe data from seven recent surgical RCTs (WAT, DRAFFT, WOLLF, FASHION, CSAW, FIXDT, TOPKAT), and outline possible group sequential designs that could plausibly have been proposed at the design stage. We then simulate how these group sequential designs could have proceeded, by using the observed data and dates to replicate how information could have accumulated and decisions been made for each RCT. RESULTS: The results of the simulated group sequential designs showed that for two of the RCTs it was highly likely that they would have stopped for futility at interim analyses, potentially saving considerable time (15 and 23 months) and costs and avoiding patients being exposed to interventions that were either ineffective or no better than standard care. We discuss the characteristics of RCTs that are important in order to use the methodology we describe, particularly the value of early outcomes and the window of opportunity when early stopping decisions can be made and how it is related to the length of recruitment period and follow-up. CONCLUSIONS: The results for five of the RCTs tested showed that group sequential designs using early outcome data would have been feasible and likely to provide designs that were at least as efficient, and possibly more efficient, than the original fixed sample size designs. In general, the amount of information provided by the early outcomes was surprisingly large, due to the strength of correlations with the primary outcome. This suggests that the methods described here are likely to provide benefits more generally across the range of surgical trials and more widely in other application areas where trial designs, outcomes and follow-up patterns are structured and behave similarly.

Five-year outcomes for patients sustaining severe fractures of the lower limb : mid-term results from the Wound management for Open Lower Limb Fracture (WOLLF) trial.

AIMS: The aim of this study was to report the outcomes of patients with severe open fractures of the lower limb in the five years after they took part in the Wound management for Open Lower Limb Fracture (WOLLF) trial. METHODS: The WOLLF trial compared standard dressings to negative pressure wound therapy (NPWT) applied at the end of the first surgical wound debridement, and patients were followed-up for 12 months. At 12 months, 170 of the original 460 participants agreed to take part in this medium-term follow-up study. Patients reported their Disability Rating Index (DRI) (0 to 100, where 100 is total disability) and health-related quality of life (HRQoL) using the EuroQol five-dimension three-level health questionnaire (EQ-5D-3L) annually by self-reported questionnaire. Further surgical interventions related to the open fracture were also recorded. RESULTS: There was no evidence of a difference in patient-reported disability, HRQoL, or the need for further surgery between patients treated with NPWT versus standard dressings at five years. Considering the combined results for all participants, there was a small but statistically significant change in DRI scores over time (1.6 units per year; p = 0.005), but no evidence that EQ-5D-3L scores changed significantly during years two to five (p = 0.551). CONCLUSION: This study shows that the high levels of disability and reduced HRQoL reported by patients 12 months after severe open fractures of the lower limb persist in the medium term, with little evidence of improvement between years two and five. Cite this article: Bone Joint J 2022;104-B(5):633-639.

Arthroscopic hip surgery compared with personalised hip therapy in people over 16 years old with femoroacetabular impingement syndrome: UK FASHIoN RCT.

BACKGROUND: Femoroacetabular impingement syndrome is an important cause of hip pain in young adults. It can be treated by arthroscopic hip surgery or with physiotherapist-led conservative care. OBJECTIVE: To compare the clinical effectiveness and cost-effectiveness of hip arthroscopy with best conservative care. DESIGN: The UK FASHIoN (full trial of arthroscopic surgery for hip impingement compared with non-operative care) trial was a pragmatic, multicentre, randomised controlled trial that was carried out at 23 NHS hospitals. PARTICIPANTS: Participants were included if they had femoroacetabular impingement, were aged ≥ 16 years old, had hip pain with radiographic features of cam or pincer morphology (but no osteoarthritis) and were believed to be likely to benefit from hip arthroscopy. INTERVENTION: Participants were randomly allocated (1 : 1) to receive hip arthroscopy followed by postoperative physiotherapy, or personalised hip therapy (i.e. an individualised physiotherapist-led programme of conservative care). Randomisation was stratified by impingement type and recruiting centre using a central telephone randomisation service. Outcome assessment and analysis were masked. MAIN OUTCOME MEASURE: The primary outcome was hip-related quality of life, measured by the patient-reported International Hip Outcome Tool (iHOT-33) 12 months after randomisation, and analysed by intention to treat. RESULTS: Between July 2012 and July 2016, 648 eligible patients were identified and 348 participants were recruited. In total, 171 participants were allocated to receive hip arthroscopy and 177 participants were allocated to receive personalised hip therapy. Three further patients were excluded from the trial after randomisation because they did not meet the eligibility criteria. Follow-up at the primary outcome assessment was 92% (N = 319; hip arthroscopy, n = 157; personalised hip therapy, n = 162). At 12 months, mean International Hip Outcome Tool (iHOT-33) score had improved from 39.2 (standard deviation 20.9) points to 58.8 (standard deviation 27.2) points for participants in the hip arthroscopy group, and from 35.6 (standard deviation 18.2) points to 49.7 (standard deviation 25.5) points for participants in personalised hip therapy group. In the primary analysis, the mean difference in International Hip Outcome Tool scores, adjusted for impingement type, sex, baseline International Hip Outcome Tool score and centre, was 6.8 (95% confidence interval 1.7 to 12.0) points in favour of hip arthroscopy (p = 0.0093). This estimate of treatment effect exceeded the minimum clinically important difference (6.1 points). Five (83%) of six serious adverse events in the hip arthroscopy group were related to treatment and one serious adverse event in the personalised hip therapy group was not. Thirty-eight (24%) personalised hip therapy patients chose to have hip arthroscopy between 1 and 3 years after randomisation. Nineteen (12%) hip arthroscopy patients had a revision arthroscopy. Eleven (7%) personalised hip therapy patients and three (2%) hip arthroscopy patients had a hip replacement within 3 years. LIMITATIONS: Study participants and treating clinicians were not blinded to the intervention arm. Delays were encountered in participants accessing treatment, particularly surgery. Follow-up lasted for 3 years. CONCLUSION: Hip arthroscopy and personalised hip therapy both improved hip-related quality of life for patients with femoroacetabular impingement syndrome. Hip arthroscopy led to a greater improvement in quality of life than personalised hip therapy, and this difference was clinically significant at 12 months. This study does not demonstrate cost-effectiveness of hip arthroscopy compared with personalised hip therapy within the first 12 months. Further follow-up will reveal whether or not the clinical benefits of hip arthroscopy are maintained and whether or not it is cost-effective in the long term. TRIAL REGISTRATION: Current Controlled Trials ISRCTN64081839. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 16. See the NIHR Journals Library website for further project information.

In some people, the ball and the socket of the hip joint develop so that they do not fit together properly. This is called hip impingement, and is an important cause of hip and groin pain in young and middle-aged adults. Treatments include physiotherapy and surgery. Physiotherapy typically involves a programme of 6­10 outpatient consultations that aim to strengthen the muscles around the hip: we called this personalised hip therapy. Surgery can be carried out by a keyhole operation, called a hip arthroscopy, which aims to reshape the hip to prevent impingement. Surgery is normally followed by some physiotherapy. We performed a research study to compare the results of hip arthroscopy and personalised hip therapy in people with hip impingement. A total of 348 people with painful hip impingement in 23 hospitals in the UK agreed to take part. About half were treated with hip arthroscopy and half with personalised hip therapy. We used questionnaires to ask participants about pain in the hip and their ability to do everyday things at 6 months and 1 year after entering the study. At 2 and 3 years, we asked if patients required any additional treatments. We found that both groups improved, but those treated with hip arthroscopy improved a moderate amount more than those treated with personalised hip therapy. However, these improvements were not cost-effective compared with personalised hip therapy at 1 year. We need to see whether or not this difference continues after several years, but the results, so far, suggest that if a person has painful hip impingement, then hip arthroscopy offers greater improvements than personalised hip therapy.

Patient beliefs and perceptions play a crucial role in the decision-making process when managing a meniscal tear. A qualitative systematic review of the literature.

INTRODUCTION: There has been an increase in research on the effectiveness of treatment options for the management of meniscal tears. However, there is very little evidence about the patient experiences of meniscal tears. AIM: To summarise the available qualitative evidence on patients' experiences and expectations of meniscal tears. METHOD: A search of EMBASE, Medline, Sociofile and Web of Science up to November 2020 was performed to identify studies reporting patient experiences of meniscal tears. Studies were critically appraised using the CASP (Critical Appraisal Skills Program) checklist, and a meta-synthesis was performed to generate third-order constructs (new themes). RESULTS: Two studies reporting semi-structured interviews from 34 participants (24 male; 10 female) were included. The mean interview length ranged from 16 to 45 min. Five themes were generated: (1) the imaging (MRI) results are a key driver in the decision-making process, (2) surgery is perceived to be the definitive and quicker approach, (3) physiotherapy and exercise is a slower approach which brought success over time, (4) patient perceptions and preferences are important in the clinical decision-making process and, (5) the impact on patient lives is a huge driver in seeking care and treatment decisions. CONCLUSION: This is the first study to summarise the qualitative evidence on patient experiences with meniscal tears. The themes generated demonstrate the importance of patient perceptions of MRI findings and timing of treatment success as important factors in the decision-making process. This study demonstrates the need to strengthen our understanding of patients' experiences of meniscal tears.

Wound photography for evaluation of surgical site infection and wound healing after lower limb trauma.

AIMS: Deep surgical site infection (SSI) is common after lower limb fracture. We compared the diagnosis of deep SSI using alternative methods of data collection and examined the agreement of clinical photography and in-person clinical assessment by the Centers for Disease Control and Prevention (CDC) criteria after lower limb fracture surgery. METHODS: Data from two large, UK-based multicentre randomized controlled major trauma trials investigating SSI and wound healing after surgical repair of open lower limb fractures that could not be primarily closed (UK WOLLF), and surgical incisions for fractures that were primarily closed (UK WHiST), were examined. Trial interventions were standard wound care management and negative pressure wound therapy after initial surgical debridement. Wound outcomes were collected from 30 days to six weeks. We compared the level of agreement between wound photography and clinical assessment of CDC-defined SSI. We are also assessed the level of agreement between blinded independent assessors of the photographs. RESULTS: Rates of CDC-defined deep SSI were 7.6% (35/460) after open fracture and 6.3% (95/1519) after closed incisional repair. Photographs were obtained for 77% and 73% of WOLLF and WHiST cohorts respectively (all participants n = 1,478). Agreement between photographic-SSI and CDC-SSI was fair for open fracture wounds (83%; k = 0.27 (95% confidence interval (CI) 0.14 to 0.42)) and for closed incisional wounds (88%; k = 0.29 (95% CI 0.20 to 0.37)) although the rate of photographically detected deep SSIs was twice as high as CDC-SSI (12% vs 6%). Agreement between different assessors for photographic-SSI (WOLLF 88%, k = 0.63 (95% CI 0.52 to 0.72); WHiST 89%; k = 0.61 (95% CI 0.54 to 0.69)); and wound healing was good (WOLLF 90%; k = 0.80 (95% CI 0.73 to 0.86); WHiST 87%; k = 0.57 (95% CI 0.50 to 0.64)). CONCLUSION: Although wound photography was feasible within the research context and inter-rater assessor agreement substantial, digital photographs used in isolation overestimated deep SSI rates, when compared to CDC criteria. Wound photography should not replace clinical assessment in pragmatic trials but may be useful for screening purposes where surgical infection outcomes are paramount. Cite this article: Bone Joint J 2021;103-B(12):1802-1808.

Use of cast immobilisation versus removable brace in adults with an ankle fracture: multicentre randomised controlled trial.

OBJECTIVES: To assess function, quality of life, resource use, and complications in adults treated with plaster cast immobilisation versus a removable brace for ankle fracture. DESIGN: Multicentre randomised controlled trial. SETTING: 20 trauma units in the UK National Health Service. PARTICIPANTS: 669 adults aged 18 years and older with an acute ankle fracture suitable for cast immobilisation: 334 were randomised to a plaster cast and 335 to a removable brace. INTERVENTIONS: A below the knee cast was applied and ankle range of movement exercises started on cast removal. The removable brace was fitted, and ankle range of movement exercises were started immediately. MAIN OUTCOME MEASURES: Primary outcome was the Olerud Molander ankle score at 16 weeks, analysed by intention to treat. Secondary outcomes were Manchester-Oxford foot questionnaire, disability rating index, quality of life, and complications at 6, 10, and 16 weeks. RESULTS: The mean age of participants was 46 years (SD 17 years) and 381 (57%) were women. 502 (75%) participants completed the study. No statistically significant difference was found in the Olerud Molander ankle score between the cast and removable brace groups at 16 weeks (favours brace: 1.8, 95% confidence interval -2.0 to 5.6). No clinically significant differences were found in the Olerud Molander ankle scores at other time points, in the secondary unadjusted, imputed, or per protocol analyses. CONCLUSIONS: Traditional plaster casting was not found to be superior to functional bracing in adults with an ankle fracture. No statistically difference was found in the Olerud Molander ankle score between the trial arms at 16 weeks. TRIAL REGISTRATION: ISRCTN registry ISRCTN15537280.

Open reduction and internal fixation versus nonoperative treatment for closed, displaced, intra-articular fractures of the calcaneus: long-term follow-up from the HeFT randomized controlled trial.

AIMS: We report the long-term outcomes of the UK Heel Fracture Trial (HeFT), a pragmatic, multicentre, two-arm, assessor-blinded, randomized controlled trial. METHODS: HeFT recruited 151 patients aged over 16 years with closed displaced, intra-articular fractures of the calcaneus. Patients with significant deformity causing fibular impingement, peripheral vascular disease, or other significant limb injuries were excluded. Participants were randomly allocated to open reduction and internal fixation (ORIF) or nonoperative treatment. We report Kerr-Atkins scores, self-reported difficulty walking and fitting shoes, and additional surgical procedures at 36, 48, and 60 months. RESULTS: Overall, 60-month outcome data were available for 118 patients (78%; 52 ORIF, 66 nonoperative). After 60 months, mean Kerr-Atkins scores were 79.2 (SD 21.5) for ORIF and 76.4 (SD 22.5) for nonoperative. Mixed effects regression analysis gave an estimated effect size of -0.14 points (95% confidence interval -8.87 to 8.59; p = 0.975) in favour of ORIF. There were no between group differences in difficulty walking (p = 0.175), or on the type of shoes worn (p = 0.432) at 60 months. Additional surgical procedures were conducted on ten participants allocated ORIF, compared to four in the nonoperative group (p = 0.043). CONCLUSION: ORIF of displaced intra-articular calcaneal fractures, not causing fibular impingement, showed no difference in outcomes at 60 months compared to nonoperative treatment, but with an increased risk of additional surgery. Cite this article: Bone Joint J 2021;103-B(6):1040-1046.

Does performance-based remuneration improve outcomes in the treatment of hip fracture?

AIMS: The aim of this study was to determine whether national standards of best practice are associated with improved health-related quality of life (HRQoL) outcomes in hip fracture patients. METHODS: This was a multicentre cohort study conducted in 20 acute UK NHS hospitals treating hip fracture patients. Patients aged ≥ 60 years treated operatively for a hip fracture were eligible for inclusion. Regression models were fitted to each of the "Best Practice Tariff" indicators and overall attainment. The impact of attainment on HRQoL was assessed by quantifying improvement in EuroQol five-dimension five-level questionnaire (EQ-5D-5L) from estimated regression model coefficients. RESULTS: A total of 6,532 patients provided both baseline and four-month EQ-5D-5L, of whom 1,060 participants had died at follow-up. Best practice was achieved in the care of 57% of participants; there was no difference in age, cognitive ability, and mobility at baseline for the overall attainment and non-attainment groups. Attaining at least 'joint care by surgeon and orthogeriatrician', 'delirium assessment', and 'falls assessment' was associated with a large, clinically relevant increase in four months EQ-5D-5L of 0.094 (bootstrapped 95% confidence interval (CI) 0.046 to 0.146). CONCLUSION: National standards with enhanced remuneration in hip fracture care results in improvement in individual patients' HRQoL. Cite this article: Bone Joint J 2021;103-B(5):881-887.

The risks associated with tourniquet use in lower limb trauma surgery: a systematic review and meta-analysis.

PURPOSE: Tourniquet use in lower limb fracture surgery may reduce intra-operative bleeding, improve surgical field of view and reduce length of procedure. However, tourniquets may result in pain and the production of harmful metabolites cause complications or affect functional outcomes. This systematic review aimed to compare outcomes following lower limb fracture surgery performed with or without tourniquet. METHODS: We searched databases for RCTs comparing lower limb fracture surgery performed with versus without tourniquet reporting on outcomes pain, physical function, health-related quality of life, complications, cognitive function, blood loss, length of stay, length of procedure, swelling, time to union, surgical field of view, volume of anaesthetic agent, biochemical markers of inflammation and injury, and electrolyte and acid-base balance. Random-effects meta-analysis was performed. PROSPERO ID CRD42020209310. RESULTS: Six RCTs enabled inclusion of 552 procedures. Pooled analysis demonstrated that tourniquet use reduced length of procedure by 6 minutes (95% CI -10.12 to -1.87; p < 0.010). We were unable to exclude increased harms from tourniquet use. Pooled analysis showed post-operative pain score was higher in tourniquet group by 12.88 on 100-point scale (95% CI -1.25-27.02; p = 0.070). Risk differences for wound infection, deep venous thrombosis and re-operation were 0.06 (95% CI -0.00-0.12; p = 0.070), 0.05 (95% CI -0.02-0.11; p = 0.150) and 0.03 (95% CI -0.03-0.09; p = 0.340). CONCLUSION: Tourniquet use was associated with a reduced length of procedure. It is possible that tourniquets also increase incidence of important complications, but the data are too sparse to draw firm conclusions. Methodological weaknesses of the included RCTs prevent any solid conclusions being drawn for outcomes investigated. Further studies are required to address these limitations.

The use of magnetic resonance imaging (MRI) of the knee in current clinical practice: A retrospective evaluation of the MRI reports within a large NHS trust.

BACKGROUND: Magnetic resonance imaging (MRI) is one of the most widely used investigations for knee pain as it provides detailed assessment of the bone and soft tissues. The aim of this study is to report the frequency of each diagnosis identified on MRI scans of the knee and explore the relationship between MRI results and onward treatment. METHODS: Consecutive MRI reports from a large NHS trust performed in 2017 were included in this study. The hospital electronic system was consulted to identify whether a patient underwent x-ray prior to the MRI, attended an outpatient appointment or underwent surgery. RESULTS: 4466 MRI knees were performed in 2017 with 71.2% requested in primary care and 28.1% requested in secondary care. The most common diagnosis was signs of arthritis (55.2%), followed by meniscal tears (42.8%) and ACL tears (8.3%). 49.4% of patients who had an MRI attended outpatients and 15.6% underwent surgery. The rate of knee surgery was significantly higher for patients who had their scans requested in secondary care (32.9% vs 8.9%, p < 0.001). CONCLUSION: The rate of surgical intervention following MRI is low and given these results it seems unlikely that the scan changes practice in most cases. The rate of surgery and outpatient follow up was significantly higher in scans requested by secondary care. We urge clinicians avoid wasteful use of MRI and recommend the use of plain radiography prior to MRI where arthritis may be present.