Summary Background Mechanical chest compression devices have the potential to help maintain high-quality cardiopulmonary resuscitation (CPR), but despite their increasing use, little evidence exists ...for their effectiveness. We aimed to study whether the introduction of LUCAS-2 mechanical CPR into front-line emergency response vehicles would improve survival from out-of-hospital cardiac arrest. Methods The pre-hospital randomised assessment of a mechanical compression device in cardiac arrest (PARAMEDIC) trial was a pragmatic, cluster-randomised open-label trial including adults with non-traumatic, out-of-hospital cardiac arrest from four UK Ambulance Services (West Midlands, North East England, Wales, South Central). 91 urban and semi-urban ambulance stations were selected for participation. Clusters were ambulance service vehicles, which were randomly assigned (1:2) to LUCAS-2 or manual CPR. Patients received LUCAS-2 mechanical chest compression or manual chest compressions according to the first trial vehicle to arrive on scene. The primary outcome was survival at 30 days following cardiac arrest and was analysed by intention to treat. Ambulance dispatch staff and those collecting the primary outcome were masked to treatment allocation. Masking of the ambulance staff who delivered the interventions and reported initial response to treatment was not possible. The study is registered with Current Controlled Trials, number ISRCTN08233942. Findings We enrolled 4471 eligible patients (1652 assigned to the LUCAS-2 group, 2819 assigned to the control group) between April 15, 2010 and June 10, 2013. 985 (60%) patients in the LUCAS-2 group received mechanical chest compression, and 11 (<1%) patients in the control group received LUCAS-2. In the intention-to-treat analysis, 30 day survival was similar in the LUCAS-2 group (104 6% of 1652 patients) and in the manual CPR group (193 7% of 2819 patients; adjusted odds ratio OR 0·86, 95% CI 0·64–1·15). No serious adverse events were noted. Seven clinical adverse events were reported in the LUCAS-2 group (three patients with chest bruising, two with chest lacerations, and two with blood in mouth). 15 device incidents occurred during operational use. No adverse or serious adverse events were reported in the manual group. Interpretation We noted no evidence of improvement in 30 day survival with LUCAS-2 compared with manual compressions. On the basis of ours and other recent randomised trials, widespread adoption of mechanical CPR devices for routine use does not improve survival. Funding National Institute for Health Research HTA – 07/37/69.
Summary Background Most patients with hip fractures are characterised by older age (>70 years), frailty, and functional deterioration, and their long-term outcomes are poor with increased costs. We ...compared the effectiveness and cost-effectiveness of giving these patients comprehensive geriatric care in a dedicated geriatric ward versus the usual orthopaedic care. Methods We did a prospective, single-centre, randomised, parallel-group, controlled trial. Between April 18, 2008, and Dec 30, 2010, we randomly assigned home-dwelling patients with hip-fractures aged 70 years or older who were able to walk 10 m before their fracture, to either comprehensive geriatric care or orthopaedic care in the emergency department, to achieve the required sample of 400 patients. Randomisation was achieved via a web-based, computer-generated, block method with unknown block sizes. The primary outcome, analysed by intention to treat, was mobility measured with the Short Physical Performance Battery (SPPB) 4 months after surgery for the fracture. The type of treatment was not concealed from the patients or staff delivering the care, and assessors were only partly masked to the treatment during follow-up. This trial is registered with ClinicalTrials.gov , number NCT00667914. Findings We assessed 1077 patients for eligibility, and excluded 680, mainly for not meeting the inclusion criteria such as living in a nursing home or being aged less than 70 years. Of the remaining patients, we randomly assigned 198 to comprehensive geriatric care and 199 to orthopaedic care. At 4 months, 174 patients remained in the comprehensive geriatric care group and 170 in the orthopaedic care group; the main reason for dropout was death. Mean SPPB scores at 4 months were 5·12 (SE 0·20) for comprehensive geriatric care and 4·38 (SE 0·20) for orthopaedic care (between-group difference 0·74, 95% CI 0·18–1·30, p=0·010). Interpretation Immediate admission of patients aged 70 years or more with a hip fracture to comprehensive geriatric care in a dedicated ward improved mobility at 4 months, compared with the usual orthopaedic care. The results suggest that the treatment of older patients with hip fractures should be organised as orthogeriatric care. Funding Norwegian Research Council, Central Norway Regional Health Authority, St Olav Hospital Trust and Fund for Research and Innovation, Liaison Committee between Central Norway Regional Health Authority and the Norwegian University of Science and Technology, the Department of Neuroscience at the Norwegian University of Science and Technology, Foundation for Scientific and Industrial Research at the Norwegian Institute of Technology (SINTEF), and the Municipality of Trondheim.
Summary Background In a previous randomised controlled phase 2 trial, intravenous infusion of salbutamol for up to 7 days in patients with acute respiratory distress syndrome (ARDS) reduced ...extravascular lung water and plateau airway pressure. We assessed the effects of this intervention on mortality in patients with ARDS. Methods We did a multicentre, placebo-controlled, parallel-group, randomised trial at 46 UK intensive-care units between December, 2006, and March, 2010. Intubated and mechanically ventilated patients (aged ≥16 years) within 72 h of ARDS onset were randomly assigned to receive either salbutamol (15 μg/kg ideal bodyweight per h) or placebo for up to 7 days. Randomisation was done by a central telephone or web-based randomisation service with minmisation by centre, pressure of arterial oxygen to fractional inspired oxygen concentration (PaO2 /FI O2 ) ratio, and age. All participants, caregivers, and investigators were masked to group allocation. The primary outcome was death within 28 days of randomisation. Analysis was by intention-to-treat. This trial is registered, ISRCTN38366450 and EudraCT number 2006-002647-86. Findings We randomly assigned 162 patients to the salbutamol group and 164 to the placebo group. One patient in each group withdrew consent. Recruitment was stopped after the second interim analysis because of safety concerns. Salbutamol increased 28-day mortality (55 34% of 161 patients died in the salbutamol group vs 38 (23%) of 163 in the placebo group; risk ratio RR 1·47, 95% CI 1·03–2·08). Interpretation Treatment with intravenous salbutamol early in the course of ARDS was poorly tolerated. Treatment is unlikely to be beneficial, and could worsen outcomes. Routine use of β-2 agonist treatment in ventilated patients with this disorder cannot be recommended. Funding UK Medical Research Council, UK Department of Health, UK Intensive Care Foundation.
Summary Background Low-back pain is a common and costly problem. We estimated the effectiveness of a group cognitive behavioural intervention in addition to best practice advice in people with ...low-back pain in primary care. Methods In this pragmatic, multicentre, randomised controlled trial with parallel cost-effectiveness analysis undertaken in England, 701 adults with troublesome subacute or chronic low-back pain were recruited from 56 general practices and received an active management advisory consultation. Participants were randomly assigned by computer-generated block randomisation to receive an additional assessment and up to six sessions of a group cognitive behavioural intervention (n=468) or no further intervention (control; n=233). Primary outcomes were the change from baseline in Roland Morris disability questionnaire and modified Von Korff scores at 12 months. Assessment of outcomes was blinded and followed the intention-to-treat principle, including all randomised participants who provided follow-up data. This study is registered, number ISRCTN54717854. Findings 399 (85%) participants in the cognitive behavioural intervention group and 199 (85%) participants in the control group were included in the primary analysis at 12 months. The most frequent reason for participant withdrawal was unwillingness to complete questionnaires. At 12 months, mean change from baseline in the Roland Morris questionnaire score was 1·1 points (95% CI 0·39–1·72) in the control group and 2·4 points (1·89–2·84) in the cognitive behavioural intervention group (difference between groups 1·3 points, 0·56–2·06; p=0·0008). The modified Von Korff disability score changed by 5·4% (1·99–8·90) and 13·8% (11·39–16·28), respectively (difference between groups 8·4%, 4·47–12·32; p<0·0001). The modified Von Korff pain score changed by 6·4% (3·14–9·66) and 13·4% (10·77–15·96), respectively (difference between groups 7·0%, 3·12–10·81; p<0·0001). The additional quality-adjusted life-year (QALY) gained from cognitive behavioural intervention was 0·099; the incremental cost per QALY was £1786, and the probability of cost-effectiveness was greater than 90% at a threshold of £3000 per QALY. There were no serious adverse events attributable to either treatment. Interpretation Over 1 year, the cognitive behavioural intervention had a sustained effect on troublesome subacute and chronic low-back pain at a low cost to the health-care provider. Funding National Institute for Health Research Health Technology Assessment Programme.
Background
:
People with Parkinson’s (PwP) have a higher tendency to adopt sedentary lifestyle behaviours and have lower physical activity levels compared to their healthy peers. Previous research ...has indicated that personal factors including poor outcome expectation and low self-efficacy are stronger predictors of exercise adherence than disease severity.
:
The purpose of this review is to synthesize the best available evidence on interventions that encompass self-management strategies to overcome barriers to exercise and improve self-efficacy and exercise adherence among PwP.
Methods
:
The following databases will be searched using a comprehensive search strategy: EBSCO, Medline, CINAHL, Web of Science, PubMed, Embase, Scopus, Google Scholar and Cochrane Library from database inception to 2020. Interventional studies including behavioural change interventions will be included in this review. The title, abstract and full-text screening will be conducted by two independent reviewers. The Joanne Briggs Institute Checklist will be used to assess the quality of each included study. Data will be extracted by two independent reviewers. The outcomes of interest will be self-efficacy outcomes and measures of exercise adherence. A systematic narrative synthesis will be conducted using a framework analysis, applying the Theoretical Domains Framework and Behaviour Change Wheel, producing findings focusing on practice-orientated outcomes. Presentation of data will include tables and text summarizing the characteristics and findings of the eligible studies. Data synthesis and statistical analysis will be performed in Review manager 5.3. The quality of evidence will be reviewed using the GRADE criteria.
Discussion
:
The review will comprehensively synthesize the available evidence on interventions to enhance self-efficacy, improve quality of life, physical function, ultimately improving exercise adherence among PwP and provide invaluable information for healthcare professionals.. This review will make recommendations for appropriate self-management strategies for maximum effect and may have implications for policy and practice regarding enhancing self-efficacy and long-term exercise adherence among PwP.
Summary Background Depression is common and is associated with poor outcomes among elderly care-home residents. Exercise is a promising low-risk intervention for depression in this population. We ...tested the hypothesis that a moderate intensity exercise programme would reduce the burden of depressive symptoms in residents of care homes. Methods We did a cluster-randomised controlled trial in care homes in two regions in England; northeast London, and Coventry and Warwickshire. Residents aged 65 years or older were eligible for inclusion. A statistician independent of the study randomised each home (1 to 1·5 ratio, stratified by location, minimised by type of home provider local authority, voluntary, private and care home, private and nursing home and size of home <32 or ≥32 residents) into intervention and control groups. The intervention package included depression awareness training for care-home staff, 45 min physiotherapist-led group exercise sessions for residents (delivered twice weekly), and a whole home component designed to encourage more physical activity in daily life. The control consisted of only the depression awareness training. Researchers collecting follow-up data from individual participants and the participants themselves were inevitably aware of home randomisation because of the physiotherapists' activities within the home. A researcher masked to study allocation coded NHS routine data. The primary outcome was number of depressive symptoms on the geriatric depression scale-15 (GDS-15). Follow-up was for 12 months. This trial is registered with ISRCTN Register, number ISRCTN43769277. Findings Care homes were randomised between Dec 15, 2008, and April 9, 2010. At randomisation, 891 individuals in 78 care homes (35 intervention, 43 control) had provided baseline data. We delivered 3191 group exercise sessions attended on average by five study participants and five non-study residents. Of residents with a GDS-15 score, 374 of 765 (49%) were depressed at baseline; 484 of 765 (63%) provided 12 month follow-up scores. Overall the GDS-15 score was 0·13 (95% CI −0·33 to 0·60) points higher (worse) at 12 months for the intervention group compared with the control group. Among residents depressed at baseline, GDS-15 score was 0·22 (95% CI −0·52 to 0·95) points higher at 6 months in the intervention group than in the control group. In an end of study cross-sectional analysis, including 132 additional residents joining after randomisation, the odds of being depressed were 0·76 (95% CI 0·53 to 1·09) for the intervention group compared with the control group. Interpretation This moderately intense exercise programme did not reduce depressive symptoms in residents of care homes. In this frail population, alternative strategies to manage psychological symptoms are required. Funding National Institute for Health Research Health Technology Assessment.
Summary Background Little is known about the effectiveness of treatments for acute whiplash injury. We aimed to estimate whether training of staff in emergency departments to provide active ...management consultations was more effective than usual consultations (Step 1) and to estimate whether a physiotherapy package was more effective than one additional physiotherapy advice session in patients with persisting symptoms (Step 2). Methods Step 1 was a pragmatic, cluster randomised trial of 12 NHS Trust hospitals including 15 emergency departments who treated patients with acute whiplash associated disorder of grades I–III. The hospitals were randomised by clusters to either active management or usual care consultations. In Step 2, we used a nested individually randomised trial. Patients were randomly assigned to receive either a package of up to six physiotherapy sessions or a single advice session. Randomisation in Step 2 was stratified by centre. Investigator-masked outcomes were obtained at 4, 8, and 12 months. Masking of clinicians and patients was not possible in all steps of the trial. The primary outcome was the Neck Disability Index (NDI). Analysis was intention to treat, and included an economic evaluation. The study is registered ISRCTN33302125. Findings Recruitment ran from Dec 5, 2005 to Nov 30, 2007. Follow-up was completed on Dec 19, 2008. In Step 1, 12 NHS Trusts were randomised, and 3851 of 6952 eligible patients agreed to participate (1598 patients were assigned to usual care and 2253 patients were assigned to active management). 2704 (70%) of 3851 patients provided data at 12 months. NDI score did not differ between active management and usual care consultations (difference at 12 months 0·5, 95% CI −1·5 to 2·5). In Step 2, 599 patients were randomly assigned to receive either advice (299 patients) or a physiotherapy package (300 patients). 479 (80%) patients provided data at 12 months. The physiotherapy package at 4 months showed a modest benefit compared to advice (NDI difference −3·7, −6·1 to −1·3), but not at 8 or 12 months. Active management consultations and the physiotherapy package were more expensive than usual care and single advice session. No treatment-related serious adverse events or deaths were noted. Interpretation Provision of active management consultation did not show additional benefit. A package of physiotherapy gave a modest acceleration to early recovery of persisting symptoms but was not cost effective from a UK NHS perspective. Usual consultations in emergency departments and a single physiotherapy advice session for persistent symptoms are recommended. Funding NIHR Health Technology Assessment programme.
Context:
People with Parkinson’s (PwP) have a higher tendency to engage in sedentary lifestyle behaviours and have lower physical activity levels compared to their healthy peers. Previous research ...has indicated that personal factors including poor outcome expectation and low self-efficacy are stronger predictors of exercise adherence than disease severity.
Objectives:
The purpose of this review is to synthesize the best available evidence on interventions that encompass self-management strategies to overcome barriers to exercise and improve self-efficacy and exercise adherence among PwP.
Methods:
The following databases will be searched using a comprehensive search strategy: EBSCO, Medline, Cinhal, Web of Science, PubMed, Embase, Scopus, Google Scholar
and Cochrane Library from database inception to 2020. The title, abstract and full-text screening will be conducted by two independent reviewers. The Joanne Briggs Institute Checklist will be used to assess the quality of each included study. The quality of evidence will be reviewed using the GRADE criteria. Data will be extracted by two independent reviewers. The outcomes of interest will be self-efficacy outcomes and measures of exercise adherence. A systematic narrative synthesis will be conducted using a framework analysis, applying the Theoretical Domains Framework and Behaviour Change Wheel, producing findings focusing on practice-orientated outcomes. Presentation of data will include tables and text summarizing the characteristics and findings of the eligible studies.
Discussion:
The review will synthesize the best available evidence on interventions to enhance self-efficacy, improve quality of life, physical function, and ultimately improve exercise adherence among PwP and provide invaluable information for healthcare professionals. The findings of this review will be disseminated through publication in a peer-reviewed journal and presented at relevant conference proceedings. This review will make recommendations for appropriate self-management strategies for maximum effect and may have implications for policy and practice regarding enhancing self-efficacy and long-term exercise adherence among PwP.
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