Advice only versus advice and a physiotherapy programme for acute traumatic anterior shoulder dislocation: the ARTISAN RCT.

Background: The extra benefit of a programme of physiotherapy in addition to advice alone, following first-time traumatic shoulder dislocation, is uncertain. We compared the clinical and cost-effectiveness of a single session of advice with a single session of advice and a programme of physiotherapy. Objective: The primary objective was to quantify and draw inferences about observed differences in the Oxford Shoulder Instability Score between the trial treatment groups 6 months post randomisation, in adults with a first-time traumatic shoulder dislocation. Design: A pragmatic, multicentre, superiority, randomised controlled trial with embedded qualitative study. Setting: Forty-one hospitals in the UK NHS. Participants: Adults with a radiologically confirmed first-time traumatic anterior shoulder dislocation, being managed non-operatively. People with neurovascular complications or bilateral dislocations, and those unable to adhere to trial procedures or unable to attend physiotherapy within 6 weeks of injury, or who had previously been randomised, were excluded. Interventions: All participants received the same initial shoulder examination followed by advice to aid self-management, lasting up to 1 hour and administered by a physiotherapist (control). Participants randomised to receive an additional programme of physiotherapy were offered sessions lasting for up to 30 minutes, over a maximum duration of 4 months from the date of randomisation (intervention). Main outcome measures: The primary outcome measure was the Oxford Shoulder Instability Score. This is a self-completed outcome measure containing 12 questions (0-4 points each), with possible scores from 0 (worst function) to 48 (best function). Measurements were collected at 6 weeks, 3 months, 6 months and 12 months by postal questionnaire; 6 months was the primary outcome time point. The primary health outcome for economic evaluation was the quality-adjusted life-year, in accordance with National Institute of Health and Care Excellence guidelines. Results: Between 14 November 2018 and 14 March 2022, 482 participants were randomised to advice (n = 240) or advice and a programme of physiotherapy (n = 242). Participants were 34% female, with a mean age of 45 years, and treatment arms were balanced at baseline. There was not a statistically significant difference in the primary outcome between advice only and advice plus a programme of physiotherapy at 6 months for the primary intention-to-treat adjusted analysis (favours physiotherapy: 1.5, 95% confidence interval -0.3 to 3.5) or at earlier 3-month and 6-week time points on the Oxford Shoulder Instability Score (0-48; higher scores indicate better function). The probability of physiotherapy being cost-effective at a willingness-to-pay threshold of £30,000 was 0.95. Conclusions: We found little difference in the primary outcome or other secondary outcomes. Advice with additional physiotherapy sessions was found likely to be cost-effective. However, small imprecise incremental costs and quality-adjusted life-years raise questions on whether it is the best use of scarce physiotherapy resources given current service demands. Limitations: Loss to follow-up was 27%; however, the observed standard deviation was much smaller than anticipated. These changes in parameters reduced the number of participants required to observe the planned target difference of four points. Our post hoc sensitivity analysis, accounting for missing data, gives similar results. Future work: Further research should be directed towards optimising self-management strategies. Study registration: This study is registered as ISRCTN63184243. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/167/56) and is published in full in Health Technology Assessment; Vol. 28, No. 22. See the NIHR Funding and Awards website for further award information.

The shoulder dislocates (comes out of its socket joint) when the upper end of the arm bone is forced out during an injury. This common problem occurs mostly in men in their 20s and women aged over 80. After the bone is put back in its socket, most people are managed with physiotherapy. In the United Kingdom, once the bone is back in its socket, there is a range of physiotherapy provision: some hospitals offer advice, and some offer advice and a course of additional physiotherapy sessions. We compared advice alone to advice and physiotherapy for people who had a shoulder that had come out of its joint for the first time. Physiotherapy advice and additional sessions included education about the injury and exercises to move and strengthen the shoulder. When we started this project, this was the first time these two treatments had been compared. Our aim was to compare what activities the two groups could do 6 months after injury via a questionnaire. We also compared quality of life and the cost of rehabilitation at 6 weeks, 3 months, 6 months and 12 months after injury. Adults with a shoulder out of its joint and who were not having surgery were asked to take part. All adults who were eligible and consented to take part were assigned, by chance, to either a single session of advice or the same session followed by physiotherapy. Between 14 November 2018 and 14 March 2022 we collected data on 482 people, from 41 NHS sites across the UK. We found at 6 months there was little evidence that additional physiotherapy was better, when compared to advice alone. Cost-effectiveness analysis (comparing changes in costs and quality of life) suggests additional physiotherapy might provide value for money. However, the changes involved are small and uncertain.

Clinical effectiveness of an online supervised group physical and mental health rehabilitation programme for adults with post-covid-19 condition (REGAIN study): multicentre randomised controlled trial.

OBJECTIVE: To evaluate whether a structured online supervised group physical and mental health rehabilitation programme can improve health related quality of life compared with usual care in adults with post-covid-19 condition (long covid). DESIGN: Pragmatic, multicentre, parallel group, superiority randomised controlled trial. SETTING: England and Wales, with home based interventions delivered remotely online from a single trial hub. PARTICIPANTS: 585 adults (26-86 years) discharged from NHS hospitals at least three months previously after covid-19 and with ongoing physical and/or mental health sequelae (post-covid-19 condition), randomised (1:1.03) to receive the Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) intervention (n=298) or usual care (n=287). INTERVENTIONS: Best practice usual care was a single online session of advice and support with a trained practitioner. The REGAIN intervention was delivered online over eight weeks and consisted of weekly home based, live, supervised, group exercise and psychological support sessions. MAIN OUTCOME MEASURES: The primary outcome was health related quality of life using the patient reported outcomes measurement information system (PROMIS) preference (PROPr) score at three months. Secondary outcomes, measured at three, six, and 12 months, included PROMIS subscores (depression, fatigue, sleep disturbance, pain interference, physical function, social roles/activities, and cognitive function), severity of post-traumatic stress disorder, general health, and adverse events. RESULTS: Between January 2021 and July 2022, 39 697 people were invited to take part in the study and 725 were contacted and eligible. 585 participants were randomised. Mean age was 56 (standard deviation (SD) 12) years, 52% were female participants, mean health related quality of life PROMIS-PROPr score was 0.20 (SD 0.17), and mean time from hospital discharge was 323 (SD 144) days. Compared with usual care, the REGAIN intervention led to improvements in health related quality of life (adjusted mean difference in PROPr score 0.03 (95% confidence interval 0.01 to 0.05), P=0.02) at three months, driven predominantly by greater improvements in the PROMIS subscores for depression (1.39 (0.06 to 2.71), P=0.04), fatigue (2.50 (1.19 to 3.81), P<0.001), and pain interference (1.80 (0.50 to 3.11), P=0.01). Effects were sustained at 12 months (0.03 (0.01 to 0.06), P=0.02). Of 21 serious adverse events, only one was possibly related to the REGAIN intervention. In the intervention group, 141 (47%) participants fully adhered to the programme, 117 (39%) partially adhered, and 40 (13%) did not receive the intervention. CONCLUSIONS: In adults with post-covid-19 condition, an online, home based, supervised, group physical and mental health rehabilitation programme was clinically effective at improving health related quality of life at three and 12 months compared with usual care. TRIAL REGISTRATION: ISRCTN registry ISRCTN11466448.

Exploring the relationship between falls, fall-related psychological concerns, and personality traits in adults: A scoping review protocol.

Background and Aims: Personality traits, such as neuroticism and extraversion, are emerging as important predictors of falls. Despite their significance, existing fall prevention programs often overlook these traits, creating a notable research gap. This study aims to conduct a comprehensive scoping review to explore the existing literature on the relationships among personality traits, falls, and fall-related psychological concerns (FrPCs). Methods: This scoping review will adhere to the framework established by Arksey and O'Malley, incorporating extensions recommended by the Joanna Briggs Institute and using the PRISMA-ScR checklist. A thorough search strategy will be employed, aligning with the population, concept, and context (PCC) selection criteria. Electronic databases, including MEDLINE, APA PsycINFO, Web of Science, CINAHL, and SPORTDiscus, will be searched from their inception to the present. Additionally, a manual search of the reference lists of identified and relevant full-text articles will be conducted. Two independent reviewers will screen titles and abstracts, perform full-text reviews, and extract data from pertinent articles. Discussion: Personality traits are increasingly recognized as influential predictors of falls and related psychological concerns. This review aims to make a substantial contribution to the existing literature by being the first to comprehensively explore and provide a descriptive synthesis of the relationship between personality traits and falls, as well as FrPCs in adults. It is hoped that the outcomes of this review will enhance our comprehension of the role of personality traits in falls, potentially informing future research and strategies for this critical area of study. Scoping Review Registration: This scoping review protocol was registered with Open Science Framework (https://doi.org/10.17605/OSF.IO/KR74X).

Acute rehabilitation following traumatic anterior shoulder dislocation (ARTISAN): pragmatic, multicentre, randomised controlled trial.

OBJECTIVE: To assess the effects of an additional programme of physiotherapy in adults with a first-time traumatic shoulder dislocation compared with single session of advice, supporting materials, and option to self-refer to physiotherapy. DESIGN: Pragmatic, multicentre, randomised controlled trial (ARTISAN). SETTING AND PARTICIPANTS: Trauma research teams at 41 UK NHS Trust sites screened adults with a first time traumatic anterior shoulder dislocation confirmed radiologically, being managed non-operatively. People were excluded if they presented with both shoulders dislocated, had a neurovascular complication, or were considered for surgical management. INTERVENTIONS: One session of advice, supporting materials, and option to self-refer to physiotherapy (n=240) was assessed against the same advice and supporting materials and an additional programme of physiotherapy (n=242). Analyses were on an intention-to-treat basis with secondary per protocol analyses. MAIN OUTCOME MEASURES: The primary outcome was the Oxford shoulder instability score (a single composite measure of shoulder function), measured six months after treatment allocation. Secondary outcomes included the QuickDASH, EQ-5D-5L, and complications. RESULTS: 482 participants were recruited from 40 sites in the UK. 354 (73%) participants completed the primary outcome score (n=180 allocated to advice only, n=174 allocated to advice and physiotherapy). Participants were mostly male (66%), with a mean age of 45 years. No significant difference was noted between advice compared with advice and a programme of physiotherapy at six months for the primary intention-to-treat adjusted analysis (between group difference favouring physiotherapy 1.5 (95% confidence interval -0.3 to 3.5)) or at earlier three month and six week timepoints. Complication profiles were similar across the two groups (P>0.05). CONCLUSIONS: An additional programme of current physiotherapy is not superior to advice, supporting materials, and the option to self-refer to physiotherapy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN63184243.

Route of drug administration in out-of-hospital cardiac arrest: A protocol for a randomised controlled trial (PARAMEDIC-3).

Aims: The PARAMEDIC-3 trial evaluates the clinical and cost-effectiveness of an intraosseous first strategy, compared with an intravenous first strategy, for drug administration in adults who have sustained an out-of-hospital cardiac arrest. Methods: PARAMEDIC-3 is a pragmatic, allocation concealed, open-label, multi-centre, superiority randomised controlled trial. It will recruit 15,000 patients across English and Welsh ambulance services. Adults who have sustained an out-of-hospital cardiac arrest are individually randomised to an intraosseous access first strategy or intravenous access first strategy in a 1:1 ratio through an opaque, sealed envelope system. The randomised allocation determines the route used for the first two attempts at vascular access. Participants are initially enrolled under a deferred consent model.The primary clinical-effectiveness outcome is survival at 30-days. Secondary outcomes include return of spontaneous circulation, neurological functional outcome, and health-related quality of life. Participants are followed-up to six-months following cardiac arrest. The primary health economic outcome is incremental cost per quality-adjusted life year gained. Conclusion: The PARAMEDIC-3 trial will provide key information on the clinical and cost-effectiveness of drug route in out-of-hospital cardiac arrest.Trial registration: ISRCTN14223494, registered 16/08/2021, prospectively registered.

Mpox and Chickenpox Coinfection: Case Series From Southern Nigeria.

BACKGROUND: We describe clinicoepidemiologic characteristics of mpox-chickenpox coinfection in Nigeria. METHODS: A retrospective cohort analysis was performed of confirmed mpox cases in Nigeria from January 2022 to March 2023. Mpox and chickenpox were confirmed by real-time polymerase chain reaction (RT-PCR). RESULTS: Of 94 (60.0%) suspected cases, 56 had confirmed mpox, of whom 16 (28.6%) had chickenpox coinfection. The median age of confirmed mpox cases was 29 years (interquartile range, 20-37 years), 24 were men (60.7%), 6 (10.7%) were bisexual, and 5 (8.9%) died. Mpox-chickenpox-coinfected patients had more complications than mpox-monoinfected cases (56.3% vs 22.5%, P = .015). CONCLUSIONS: The high frequency of mpox-chickenpox coinfection argues for accelerated access to mpox and chickenpox vaccines in Africa.

Rheumatoid arthritis knowledge gap and intervention in Nigeria study.

INTRODUCTION: Family physicians are often the first healthcare providers to encounter patients with rheumatoid arthritis (RA) in Nigeria, given the paucity of rheumatology services nationwide. This study aimed to assess and address the knowledge gap regarding RA among family physicians in Nigeria. METHODS: A cross-sectional survey involving 609 family physicians from all six geopolitical zones of Nigeria was conducted in October 2022. Pre-intervention questionnaires were administered to assess the participants' knowledge of RA. An investigator-led PowerPoint presentation on RA was then delivered as an intervention, followed by the same participants completing post-intervention questionnaires to evaluate knowledge improvement. Data were analyzed using the Statistical Package for Social Science, version 25. RESULTS: The mean age of participants was 42 ± 15 years, predominantly male (63.9%). The median pre-intervention knowledge score was 3.2 (IQR: 2.0-4.5), with 77.0% scoring <5. After the intervention, the median score significantly improved to 7.1 (IQR: 4.3-8.6) (p = .001), with 62.6% scoring >7. Significant improvements were observed in several knowledge areas where gaps existed pre-intervention, including the understanding that NSAIDs are not the mainstay of management (p < .001), the effectiveness of glucosamine and chondroitin sulfate (p < .001), confidence in diagnosing RA (p = .016), the recognition of joint deformities as a characteristic feature (p < .001), and the understanding that rheumatoid factor is not definitive for diagnosis (p < .001). CONCLUSION: This study highlights the importance of interventions in closing the knowledge gap about RA diagnosis and management. We recommend the implementation of a comprehensive approach to rheumatology education and services by policymakers.

UK robotic arthroplasty clinical and cost effectiveness randomised controlled trial for hips (RACER-Hip): a study protocol.

INTRODUCTION: The number of robotic-assisted hip replacement procedures has expanded globally with the intended aim of improving outcomes. Intraoperative robotic-arm systems add additional costs to total hip replacement (THR) surgery but may improve surgical precision and could contribute to diminished pain and improved function. Additionally, these systems may reduce the need for expensive revision surgery. Surgery with conventional instruments may be just as successful, quick and affordable. There is timely demand for a robust evaluation of this technology. METHODS AND ANALYSIS: The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial for Hips (RACER-Hip) is a multicentre (minimum of six UK sites), participant-assessor blinded, randomised controlled trial. 378 participants with hip osteoarthritis requiring THR will be randomised (1:1) to receive robotic-assisted THR, or THR using conventional surgical instruments. The primary outcome is the Forgotten Joint Score at 12 months post-randomisation; a patient-reported outcome measure assessing participants' awareness of their joint when undertaking daily activities. Secondary outcomes will be collected post-operatively (pain, blood loss and opioid usage) and at 3, 6, 12, 24 months, then 5 and 10 years postrandomisation (including function, pain, health-related quality of life, reoperations and satisfaction). Allocation concealment will be accomplished using a computer-based randomisation procedure on the day of surgery. Blinding methods include the use of sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will adhere to Consolidated Standards of Reporting Trials statements. ETHICS AND DISSEMINATION: The trial was approved by an ethics committee (Solihull Research Ethics Committee, 30 June 2021, IRAS: 295831). Participants will provide informed consent before agreeing to participate. Results will be disseminated using peer-reviewed journal publications, presentations at international conferences and through the use of social media. We will develop plans to disseminate to patients and public with our patient partners. TRIAL REGISTRATION NUMBER: ISRCTN13374625.

Randomised trial of the clinical and cost effectiveness of a supraglottic airway device compared with tracheal intubation for in-hospital cardiac arrest (AIRWAYS-3): Protocol, design and implementation.

Survival from in-hospital cardiac arrest is approximately 18%, but for patients who require advanced airway management survival is lower. Those who do survive are often left with significant disability. Traditionally, resuscitation of cardiac arrest patients has included tracheal intubation, however insertion of a supraglottic airway has gained popularity as an alternative approach to advanced airway management. Evidence from out-of-hospital cardiac arrest suggests no significant differences in mortality or morbidity between these two approaches, but there is no randomised evidence for airway management during in-hospital cardiac arrest. The aim of the AIRWAYS-3 randomised trial, described in this protocol paper, is to determine the clinical and cost effectiveness of a supraglottic airway versus tracheal intubation during in-hospital cardiac arrest. Patients will be allocated randomly to receive either a supraglottic airway or tracheal intubation as the initial advanced airway management. We will also estimate the relative cost-effectiveness of these two approaches. The primary outcome is functional status, measured using the modified Rankin Scale at hospital discharge or 30 days post-randomisation, whichever occurs first. AIRWAYS-3 presents ethical challenges regarding patient consent and data collection. These include the enrolment of unconscious patients without prior consent in a way that avoids methodological bias. Other complexities include the requirement to randomise patients efficiently during a time-critical cardiac arrest. Many of these challenges are encountered in other emergency care research; we discuss our approaches to addressing them. Trial registration: ISRCTN17720457. Prospectively registered on 29/07/2022.

Pattern of systemic lupus erythematosus in NIGERIA: a multicentre descriptive hospital-based study.

INTRODUCTION: Systemic lupus erythematosus (SLE) is a chronic autoimmune inflammatory disease with manifestations ranging from mild to life-threatening organ dysfunction. There is wide variability in the reported incidence and prevalence rate globally, particularly in low and middle-income countries. Nigeria had very few isolated reports of SLE from private and public hospitals Therefore, we conducted this large multi-center descriptive study to determine the sociodemographic, clinical profile, laboratory patterns, and treatment among Nigerian lupus patients. METHODS: A retrospective hospital-based study of all SLE patients seen over 4 years (January 2017 to December 2020) was conducted at 20 rheumatology clinics spread across the 6 geopolitical zones of Nigeria. All patients 18 years and above satisfying the American College of Rheumatology (ACR) 1997 and/or the Systemic Lupus International Collaboration Clinics (SLICC) 2012 classification criteria for SLE were enrolled. Patients with other Rheumatic and Musculoskeletal Diseases (RMDs) not in keeping with SLE and Patients with incomplete data were excluded. Data was analysed using SPSS version 23.0 software. RESULTS: A total of 896 patients with SLE were included in the final analysis with a mean age ± SD of 34.47 ± 11 and a female to male ratio of 8.1:1. Synovitis was reported by 61.6% of patients, while 51%, 19.9% and11.4% patients reported acute, sub-acute and chronic lupus rashes respectively. ANA was positive in 98.0% with titers ranging from 1:80 to 1:64,000. CONCLUSION: SLE is not rare in Nigeria. Most patients were female in their 3rd to 4th decades of life. There is a delayed presentation to a rheumatology facility. Arthritis and mucocutaneous manifestations were the most frequent presentation. Key Points •This study presents the first national data on SLE in Nigeria •This study showed that SLE is not rare in Nigeria in contrast to previous reports •There appear to be ethnic disparity in the frequency of lupus among Nigerians •Nigerians with lupus have very high titer of ANA.

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.

A think-aloud study of the feasibility of patients with end-stage organ failure completing the ICECAP-SCM.

BACKGROUND: The ICECAP-Supportive Care Measure (SCM) is a self-complete measure developed to inform economic decision making at the end-of-life. Previous research has demonstrated its feasibility in hospice and nursing home settings. This is the first study of its use with patients on the organ failure trajectory. AIM: To determine the feasibility of using the ICECAP-SCM with patients experiencing end-stage organ failure in a hospital setting. DESIGN: Participants were asked to 'think aloud' when completing the ICECAP-SCM, ICECAP-A and EQ-5D-5L measures. The interviews were transcribed verbatim and examined for errors in comprehension, retrieval, judgement, and response by five raters. Qualitative data were collected to explore reasons for errors in completing the measures and participants' views about the measures. SETTING/PARTICIPANTS: Sixty patients (with end-stage renal failure n = 18; end-stage heart failure n = 21; end-stage chronic obstructive pulmonary disease n = 21) participated. Senior clinicians applied prognostic criteria to determine eligibility. RESULTS: Participants reported that the measures were acceptable, clear, and easy to complete. Error rates in completing the measures were low (ICECAP-A = 3%,and ICECAP-SCM = 5.7% and EQ-5D-5L = 6.3%). There was some variation in responses between patients with different end-stage conditions, particularly those with symptom fluctuation. Some patients had not considered their end-of-life (i.e. advance care planning) and reported finding questions about this difficult to answer. CONCLUSION: It is feasible to use the ICECAP-SCM with patients with end-stage organ failure receiving care in hospital settings. This study provides evidence for researchers and policy makers involved in measuring end-of-life care globally. The ICECAP-SCM can be recommended for research with patients in end-stage organ failure to appropriately capture the broader benefits of end-of-life care.

Cost-utility analysis of cast compared to removable brace in the management of adult patients with ankle fractures.

AIMS: To compare the cost-utility of removable brace compared with cast in the management of adult patients with ankle fracture. METHODS: A within-trial economic evaluation conducted from the UK NHS and personnel social services (PSS) perspective. Health resources and quality-of-life data were collected as part of the Ankle Injury Rehabilitation (AIR) multicentre, randomized controlled trial over a 12-month period using trial case report forms and patient-completed questionnaires. Cost-utility analysis was estimated in terms of the incremental cost per quality adjusted life year (QALY) gained. Estimate uncertainty was explored by bootstrapping, visualized on the incremental cost-effectiveness ratio plane. Net monetary benefit and probability of cost-effectiveness were evaluated at a range of willingness-to-pay thresholds and visualized graphically. RESULTS: The incremental cost and QALYs of using brace over a 12-month period were £46.73 (95% confidence interval (CI) £-9 to £147) and 0.0141 (95% CI -0.005 to 0.033), respectively. The cost per QALY gained was £3,318. The probability of brace being cost-effective at a £30,000 per QALY willingness-to-pay threshold was 88%. The results remained robust to a range of sensitivity analyses. CONCLUSION: This within-trial economic evaluation found that it is probable that using a removable brace provides good value to the NHS when compared to cast, in the management of adults with ankle fracture. Cite this article: Bone Jt Open 2022;3(6):455-462.

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.

The economic burden of open tibia fractures: A systematic review.

BACKGROUND: Open tibia fractures are a common injury following road traffic collisions and place a large economic burden on patients and healthcare systems. Summarising their economic burden is key to inform policy and help prioritise treatment. METHODS: All studies were identified from a systematic search of Medline, Embase and the Cochrane Central Register of Controlled Trials. We included any human with a diagnosed open tibia fracture, following any intervention. The primary outcome was any costs reported or patient return to work status. Secondary outcomes included average length of stay, wage loss, absenteeism and complications such as infection, amputation and nonunion. Data was extracted and we performed a descriptive narrative summary. RESULTS: We reviewed 1,204 studies from our searches. A total of 34 studies were included from 14 different countries. The average age was 37.7 years old and 76% of the patients were male. 6.5% were Gustilo I, 12% Gustilo II and 82% Gustilo III. Initial direct hospitalisation costs were reported to be between £356 to £126,479 with an average length of stay of 56 days (3.1-244). 89% of participants were working pre-injury, 60% fully returned to work, 17% returned to work part time or changed profession and 22% did not return to work at one-year. The most common complications reported were 22% infection, 11% nonunion and 16% amputation. Mean follow-up duration for the studies was 25 months. CONCLUSION: The economic burden of open tibia fractures varies greatly, but it is costly for both hospitals and patients. The current evidence is predominantly from high-income countries (HICs), especially the USA. Further research is required to investigate the costs of open tibia fractures using validated costing tools, especially in low-income countries (LICs), to help inform and direct policy.

Acute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN): protocol for a multicentre randomised controlled trial.

INTRODUCTION: First-time traumatic anterior shoulder dislocation (TASD) is predominantly managed non-operatively. People sustaining TASD have ongoing pain, disability and future risk of redislocation. There are no published randomised controlled trials (RCTs) comparing different non-operative rehabilitation strategies to ascertain the optimum clinically effective approach after TASD. METHODS AND ANALYSIS: In this multicentre adaptive RCT, with internal pilot, adults with a radiologically confirmed first time TASD treated non-surgically will be screened at a minimum of 30 sites. People with neurovascular complications, bilateral dislocations or are unable to attend physiotherapy will be excluded.Randomisation will be on a 1:1 treatment allocation, stratified by age, hand dominance and site. Participants will receive a single session of advice; or a single session of advice plus offer of further physiotherapy (maximum 4 months). The primary analysis will be the difference in Oxford Shoulder Instability Score at 6 months. A sample size of a minimum of 478 participants will allow us to show a four point difference with 90% power.An embedded qualitative study will explore the participants' experiences of the trial interventions. ETHICS, REGISTRATION AND DISSEMINATION: Funded by NIHR HTA (16/167/56), 1 June 2018; National Research Ethic Committee approved (18/WA/0236), 26 July 2018. First site opened 5 November 2018 and final results will be updated on trial registries and submitted to a peer-reviewed journal and will inform rehabilitation strategies after a TASD. Study Within A Trial (SWAT) funded by MRC (MR/R013748/1), 1 May 2019; registered on the MRC-HTMR All-Ireland Hub (reference number SWAT 121). TRIAL REGISTRATION NUMBER: ISRCTN63184243. (Trial stage: Pre-results).

Synthesis and characterization of Schiff bases NBBA, MNBA and CNBA.

Three Schiff base compounds, N1,N2 -bis(3-nitrobenzylidene)phenylene diamine (NBBA), 2-methyl-N-(3-nitrobenzylidene)aniline (MNBA) and N-(2-chlorobenzylidene)-4-nitroaniline (CBNA) were synthesized, characterised and applied for the first time as potential mild steel (MS) corrosion inhibitors in 1 M HCl at 30 °C. Fourier transform infra-red (FTIR), 1H, 13C Nuclear magnetic resonance (NMR) and Mass spectrometry (MS) were used for the characterisation of the compounds. The electrochemical studies and evaluation of corrosion inhibition potency were achieved using potentiodynamic polarization (PDP) and electrochemical impedance spectroscopy (EIS) techniques. Density functional theory (DFT) calculations were further employed to describe the electronic distribution on the molecules and potential sites that aided corrosion inhibition. The results of the employed characterisation techniques confirmed the proposed structures of the compounds with the MS revealing the exact molecular mass of the compounds. Electrochemical results showed that the trend in inhibition efficiency of the three compounds was in the order: MNBA > NBBA > CBNA. MNBA recorded the highest inhibition efficiency at 100 ppm. Corrosion kinetics of the set of inhibitors was found to prefer the Langmuir adsorption isotherm with both physisorption and chemisorption mechanisms as revealed by ΔG values. In an effort to develop efficient corrosion inhibitors with non-toxic effect, low cost and multiple adsorption centres, these Schiff bases are presented.

Experimental, quantum chemical and molecular dynamic simulations studies on the corrosion inhibition of mild steel by some carbazole derivatives.

Five selected carbazole derivatives, namely carbazole, 3,6-dibromocarbazole, 2-hydroxycarbazole, 1,2,3,4-tetrahydrocarbazole and 9-(2-ethylhexyl)carbazole-3,6-dicarboxaldehyde were investigated for their inhibitive effects on Desulfovibrio vulgaris (D. vulgaris) induced corrosion of mild steel and in 1 M HCl medium using weight loss, potentiodynamic polarization and electrochemical impedance spectroscopy (EIS) techniques. The carbazole derivatives were found to be mixed type inhibitors with predominantly cathodic inhibitive effects for mild steel in 1 M HCl. Surface morphology results showed the compounds formed adsorbed film on mild steel surface in both aqueous acid and sulphate reducing bacteria (SRB) media. Quantum chemical calculations were used to provide molecular based explanations for the inhibitive effects of the compounds. The interactions of the molecules with mild steel surface was simulated based on molecular dynamic simulations approach using Fe(110) crystal surface as representative metallic surface.

Synthesis, Characterization, Antimicrobial Studies and Corrosion Inhibition Potential of 1,8-dimethyl-1,3,6,8,10,13-hexaazacyclotetradecane: Experimental and Quantum Chemical Studies.

The macrocylic ligand, 1,8-dimethyl-1,3,6,8,10,13-hexaazacyclotetradecane (MHACD) was synthesized by the demetallation of its freshly synthesized Ni(II) complex (NiMHACD). Successful synthesis of NiMHACD and the free ligand (MHACD) was confirmed by various characterization techniques, including Fourier transform infra-red (FT-IR), proton nuclear magnetic resonance (¹H-NMR), carbon-13 nuclear magnetic resonance (13C-NMR), ultraviolet-visible (UV-vis), and energy dispersive x-ray (EDX) spectroscopic techniques. The anti-bacteria activities of MHACD were investigated against Staphylococcus aureus and Enterococcus species and the results showed that MHACD possesses a spectrum of activity against the two bacteria. The electrochemical cyclic voltammetry study on MHACD revealed that it is a redox active compound with promising catalytic properties in electrochemical applications. The inhibition potential of MHACD for mild steel corrosion in 1 M HCl was investigated using potentiodynamic polarization method. The results showed that MHACD inhibits steel corrosion as a mixed-type inhibitor, and the inhibition efficiency increases with increasing concentration of MHACD. The adsorption of MHACD obeys the Langmuir adsorption isotherm; it is spontaneous and involves competitive physisorption and chemisorption mechanisms. Quantum chemical calculations revealed that the energy of the highest occupied molecular orbital (HOMO) of MHACD is high enough to favor forward donation of charges to the metal during adsorption and corrosion inhibition. Natural bond orbital (NBO) analysis revealed the presence of various orbitals in the MHACD that are capable of donating or accepting electrons under favorable conditions.