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.

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.

Development of a single-session physiotherapy and self-management intervention for the treatment of primary traumatic anterior shoulder dislocation for the 'Acute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN)' multi centre RCT.

OBJECTIVE: Optimum physiotherapy management for people with a conservatively managed primary traumatic anterior shoulder dislocation is not known. The purpose of the ARTISAN trial is to compare the clinical and cost-effectiveness of a course of usual care physiotherapy with a single session of physiotherapy and self-management, the ARTISAN intervention. ARTISAN is a UK multi-centre, two-arm, parallel group, randomised controlled trial with 1:1 treatment allocation. DESIGN: The intervention was developed following the Medical Research Council framework for developing and evaluating complex interventions and will be reported in line with the template for intervention description and replication checklist (TIDieR) and the Consensus on Exercise Reporting Template (CERT). It was informed by published research, national clinical guidelines, current clinical practice and patient and public involvement. RESULTS: The ARTISAN intervention comprises education (Phase 1), progressive exercise (Phase 2 and Phase 3) and an optional return to sport component (Phase 4). Behaviour change strategies are embedded throughout intervention. The single session of physiotherapy is delivered by a chartered physiotherapist, within the first six weeks of injury, in an NHS outpatient setting. At the end of the initial session, paper-based booklets and/or a patient website with the same content are provided to participants to aid self-management and progression though the four phases of the trial intervention. CONCLUSION: The ARTISAN intervention was successfully implemented throughout the internal pilot and is suitable for testing in the subsequent definitive RCT ARTISAN trial. Trial Registration Number ISRCTN63184243.

Development of a physiotherapist-led exercise programme for traumatic tears of the rotator cuff for the SPeEDy study.

OBJECTIVES: The SPeEDy study (Surgery vs. physiotherapist-led exercise for traumatic tears of the rotator cuff) is a two-arm, parallel group, pilot and feasibility randomised controlled trial aiming to evaluate the feasibility of a future main trial. In this paper, the development process and the resultant physiotherapist-led exercise programme used in the SPeEDy study is described. METHODS: Thirteen physiotherapists and three patients met to discuss and develop the key principles that should underpin the exercise programme. RESULTS: Taking in to account the current research evidence and incorporating expert clinical and patient opinion, the group developed an individualised, structured and progressive physiotherapist-led exercise programme based on the principle of self dosing. Exercise prescription within the programme is based on establishing the current functional capacity of the patient in relation to the most challenging shoulder movements and is supported over approximately six contact sessions across a 12-week period. CONCLUSION: The SPeEDy study aims to recruit 76 participants across eight hospitals and will provide high quality evidence about the feasibility of a future main randomised controlled trial in a clinical area where there is a lack of evidence from randomised controlled trials to support clinical decision-making. ClinicalTrials.gov (NCT04027205) - Registered on 19 July 2019. Available via https://clinicaltrials.gov/ct2/show/NCT04027205.

Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS).

INTRODUCTION: Shoulder pain due to irreparable rotator cuff tears can cause substantial disability, but treatment options are limited. A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use. This trial will evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing arthroscopic debridement for irreparable rotator cuff tears.New surgical procedures can provide substantial benefit to patients. Good quality randomised controlled trials (RCTs) are needed, but trials in surgery are typically long and expensive, exposing patients to risk and the healthcare system to substantial costs. One way to improve the efficiency of trials is with an adaptive sample size. Such methods are well established in drug trials but have rarely, if ever, been used in surgical trials. METHODS AND ANALYSIS: Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) is a participant and assessor blinded, adaptive, multicentre RCT comparing arthroscopic debridement with the InSpace balloon (Stryker, USA) to arthroscopic debridement alone for people with a symptomatic irreparable rotator cuff tear. It uses a group sequential adaptive design where interim analyses are performed using all of the 3, 6 and 12-month data that are available at each time point. A maximum of 221 participants will be randomised (1:1 ratio), this will provide 90% power (at the 5% level) for a 6 point difference in the primary outcome; the Oxford Shoulder Score at 12 months. A substudy will use deltoid-active MRI scans in 56 participants to assess the function of the balloon. Analysis will be on an intention-to-treat basis and reported according to principles established in the Consolidated Standards of Reporting Trials statement. ETHICS AND DISSEMINATION: NRES number 18/WM/0025. The results will be disseminated via peer-reviewed publications, presentations at conferences, lay summaries and social media. TRIAL REGISTRATION NUMBER: ISRCTN17825590.

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).

Cardiovascular emergencies in cruise ship passengers.

More than 10 million people, many elderly and likely to harbor cardiovascular (CV) disease, embark on cruise ship travel worldwide every year. The clinical presentation and outcome of CV emergencies presenting during cruise ship travel remain largely unknown. Our department provides contracted cardiology consultations to several large cruise lines. We prospectively maintained a registry of all such consultations during a 2-year period. One hundred consecutive patients were identified (age 66 +/- 14 years, range 18 to 90, 76% men). The most common symptom was chest pain (50%). The most common diagnosis was acute coronary syndrome (58%; ST elevation in 21% and non-ST elevation in 37%). On-board mortality was 3%. Overall, 73% of patients required hospital triage. Of the 25 patients triaged to our institution, 17 underwent a revascularization procedure. One patient died. Ten percent of patients had cardiac symptoms in the days or weeks before boarding; all required hospital triage. Access to a baseline electrocardiogram would have been clinically useful in 23% of cases. In conclusion, CV emergencies, such as acute coronary syndrome and heart failure, are not uncommon on cruise ships. They are often serious, requiring hospital triage and coronary revascularization. A pretravel medical evaluation is recommended for passengers with a cardiac history or a high-risk profile. Passengers should be encouraged to bring a copy of their electrocardiogram on board if abnormal. Cruise lines should establish mechanisms for prompt consultation and triage.

Simultaneous assessment of coronary stenosis, myocardial perfusion, and ventricular function in a patient with acute myocardial infarction.

Cardiac CT angiography (CTA) is an ideal tool to investigate cardiac and noncardiac causes of acute chest pain. In this case, careful planning of the CTA acquisition and reconstruction limits permitted not only the exclusion of aortic dissection and provided high resolution images of coronary anatomy but also showed a concordant abnormality in myocardial perfusion and ventricular function in the setting of an acute coronary syndrome. Detailed planning of every CTA acquisition reconstruction protocol is essential to obtain the information necessary for clinical decision-making strategies and interventions in the patient with chest pain.

Reclassification of patients for aggressive cholesterol treatment: additive value of multislice coronary angiography to the National Cholesterol Education Program guidelines.

BACKGROUND: National Cholesterol Education Program (NCEP) guidelines have been used to define treatment goals in patients with hypercholesterolemia. However, epidemiology-based guidelines are unable to identify all subjects with coronary artery disease for aggressive lipid intervention. OBJECTIVE: We sought to evaluate the additive value of multislice computed tomography (MSCT) angiography to the NCEP guideline classification for lipid treatment. METHODS: Multislice computed tomography was performed in 114 consecutive patients (mean age 57+/-14 y; 59% male) without known coronary artery disease. Subjects were classified into 3 categories (low-, intermediate-, and high-risk) according to their Framingham risk scores (FRS). RESULTS: Traditional cardiac risk factors were common: hypertension 59%, diabetes 13%, and smoking 22%. On the basis of the FRS, 11% (n=12/114) of the patients met high-risk criteria requiring aggressive cholesterol reduction. Of those in the low- and intermediate-risk groups, MSCT found coronary plaque in 76% (n=77/102), with moderate or severe plaque in 38% (n=39/102), thus reclassifying them in the high-risk category. Use of statin drugs increased from 32% at baseline to 53% (p=0.002) based on MSCT results; statin dose was increased in 31% of the patients who were already on a statin. The mean low-density lipoprotein cholesterol (LDL-c) decreased from 114 mg/dL to 91 mg/dL after MSCT (p<0.001). CONCLUSION: Multislice computed tomography reclassifies a high percentage of patients considered to be low- to intermediate-risk into the high-risk category based on their coronary artery lesions. Thus, the rise in MSCT use at present may have a large impact on clinician practice patterns in lipid-lowering therapy.

Use of the prehospital ECG improves door-to-balloon times in ST segment elevation myocardial infarction irrespective of time of day or day of week.

BACKGROUND: The use of the prehospital electrocardiogram (ECG) to identify patients with ST-segment elevation myocardial infarction (STEMI), coupled with a centralised system to alert the cardiac catheterisation team in preparation for prompt intervention, has been shown to reduce door-to-balloon times (DBT) effectively. A confounding variable in prolonging the recommended 90 min DBT is the time of day or day of the week of patient presentation. We postulated that use of the prehospital ECG, coupled with an emergency department initiated "Cath Alert" system, could neutralise DBT delays related to time of day or day of week. METHODS: A prospective study was conducted on 167 consecutive patients presenting to our emergency department with acute STEMI. All patients were treated with primary percutaneous coronary intervention. Patients were grouped according to time of presentation: during regular hours (Monday to Friday 08:00 to 17:00) vs off hours (after 17:00 on weekdays and all hours on weekends). Baseline recorded variables included mode of presentation, transmission of prehospital ECG, and activation of Cath Alert system. RESULTS: Overall, the mean (SD) DBT was 69 (35) mins, with the majority of patients (n = 131, 78%) achieving the recommended DBT of 90 mins. The shortest DBT occurred in patients who arrived by emergency medical services with use of the prehospital ECG and Cath Alert system (53 (21) min), while those who arrived as a walk-in without use of emergency medical services had the longest DBT (105 (38) min; p<0.001). Compared to regular hours, presentation during off hours prolonged DBT in patients presenting via emergency medical services (75 (16) vs 53 (18) min, p = 0.03). With transmission of the prehospital ECG, the delay in DBT was improved among those presenting off hours, nullifying the adverse effect of off hour presentation (54 (21) vs 49 (22) min; p = 0.26). CONCLUSION: Variables such as time of day and mode of presentation have an impact on achieving currently recommended DBT in patients with STEMI. With the addition of each prehospital variable in succession-that is, arrival by emergency medical services, Cath Alert system, and the prehospital ECG-the DBT can be progressively shortened and the adverse "off hour effect" nullified.

Drug-eluting stent implantation in ST-elevation acute myocardial infarction: 'real world' 30-day and mid-term results.

Primary percutaneous coronary intervention (PCI) with stent implantation is the preferred method of reperfusion for ST-elevation acute myocardial infarction. Concern remains over the use of drug-eluting stents in the acute ST-elevation myocardial infarction setting, with limited published reports on their use for this application. We studied 64 consecutive patients presenting with an acute ST-elevation myocardial infarction who underwent mechanical reperfusion with implantation of a drug-eluting stent. Both sirolimus- and paclitaxel-eluting stents were used. Primary outcome was the occurrence of major adverse cardiac events, defined as death, nonfatal reinfarction or clinically driven target vessel revascularization. Post-procedural success was achieved in 63 patients (98%). In-hospital mortality was 1.6%. During a median follow-up of 234 days, there were no cases of stent thrombosis, reinfarction or reintervention. These findings conducted in a 'real world' practice setting in the United States demonstrate that drug-eluting stent implantation for acute ST-elevation myocardial infarction is safe and effective, with a low rate of major adverse cardiac events during mid-term follow-up.

Renal fibromuscular dysplasia in elderly persons.

Renal artery stenosis (RAS) is a significant cause of secondary hypertension, the progression of which can lead to renal insufficiency, uncontrolled hypertension, and even end-stage renal disease. The 2 most common forms of RAS are atherosclerotic renovascular disease and fibromuscular dysplasia (FMD). Atherosclerosis accounts for 90% of all cases of RAS and generally affects an elderly population. Conversely, FMD accounts for approximately 10% of all RAS cases and is described as affecting a younger population. Four cases of FMD in individuals older than 70 years are presented, in a period of 1 year at 1 facility. This case series calls into question the previously reported low prevalence of FMD in elderly persons. It is conceivable that renal artery investigation might be denied an elderly patient thought to have atherosclerotic disease. Because conventional angioplasty is considered the treatment of choice for patients with FMD because of the high response rate for uncontrolled hypertension, the prevalence of FMD in the elderly population should be reevaluated to detect and treat this population accordingly.

Successful use of sirolimus-eluting stents for treatment of ST-elevation acute myocardial infarction caused by left main coronary artery occlusion.

We describe an ST-elevation acute myocardial infarction involving the left main coronary artery in a middle-aged man who was treated by primary angioplasty with the use of sirolimus-eluting stents. To our knowledge, this is the 1st report of survival after sirolimus-eluting stent implantation in a patient with acute occlusion of the left main coronary artery. We discuss the case and review the literature.

Combination pharmacotherapy with reduced-dose fibrinolytic and platelet GP IIb/IIIa inhibition.

Combination fibrinolytic and antiplatelet therapy regimens may provide a means of inducing rapid reperfusion in patients requiring myocardial salvage after an acute myocardial infarction (AMI). This article describes case histories and a therapeutic regimen combining reteplase (5 U + 5 U double bolus) and abciximab (0.25 mg/kg bolus + 0.125 microg/kg/min infusion to a maximum of 10 microg/min for 12 h) for AMI patients before percutaneous coronary intervention (PCI). This medication regimen was used in the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) V clinical trial, for the medical treatment of AMI, resulting in decreased reinfarction rates with similar mortality and intracranial hemorrhage rates as compared to standard fibrinolytic therapy.