Objectives To measure the effectiveness and cost effectiveness of providing care in a chest pain observation unit compared with routine care for patients with acute, undifferentiated chest pain. Design Cluster randomised controlled trial, with 442 days randomised to the chest pain observation unit or routine care, and cost effectiveness analysis from a health service costing perspective. Setting The emergency department at the Northern General Hospital, Sheffield, United Kingdom. Participants 972 patients with acute, undifferentiated chest pain (479 attending on days when care was delivered in the chest pain observation unit, 493 on days of routine care) followed up until six months after initial attendance. Main outcome measures The proportion of participants admitted to hospital, the proportion with acute coronary syndrome sent home inappropriately, major adverse cardiac events over six months, health utility, hospital reattendance and readmission, and costs per patient to the health service. Results Use of a chest pain observation unit reduced the proportion of patients admitted from 54% to 37% (difference 17%, odds ratio 0.50, 95% confidence interval 0.39 to 0.65, P < 0.001) and the proportion discharged with acute coronary syndrome from 14% to 6% (8%, -7% to 23%, P = 0.264). Rates of cardiac event were unchanged. Care in the chest pain observation unit was associated with improved health utility during follow up (0.0137 quality adjusted life years gained, 95% confidence interval 0.0030 to 0.0254, P = 0.022) and a saving of £78 per patient (-£56 to £210, P = 0.252). Conclusions Care in a chest pain observation unit can improve outcomes and may reduce costs to the health service. It seems to be more effective and more cost effective than routine care.

AimAcute bronchiolitis is the commonest cause for hospitalisation in infancy. Supportive care remains the cornerstone of current management and no other therapy has been shown to influence the course of the disease. It has been suggested that adding nebulised hypertonic saline to usual care may shorten the duration of hospitalisation. To determine whether hypertonic saline does have beneficial effects we undertook an open, multi-centre parallel-group, pragmatic RCT in ten UK hospitals.MethodsInfants admitted to hospital with a clinical diagnosis of acute bronchiolitis and requiring oxygen therapy were randomised to receive usual care alone or nebulised 3% hypertonic saline (HS) administered 6-hourly. Randomisation was within 4 h of admission. The primary outcome was time to being assessed as ‘fit’ for discharge with secondary outcomes including time to discharge, incidence of adverse events together with follow up to 28 days assessing patient centred health related outcomes.ResultsA total of 317 infants were recruited to the study. 158 infants were randomised to HS (141 analysed) and 159 to standard care (149 analysed). There was no difference between the two arms in time to being declared fit for discharge (hazard ratio: 0−95, 95% CI: 0.75−1.20) nor to actual discharge (hazard ratio: 0.97, 95% CI: 0.76−1.23). There was no difference in adverse events. One infant in the HS group developed bradycardia with desaturation.ConclusionThis study does not support the use of nebulised HS in the treatment of acute bronchiolitis over usual care with minimal handlings.ClinicalTrials.gov registration numberNCT01469845.

Summary Background Post-stroke aphasia might improve over many years with speech and language therapy; however speech and language therapy is often less readily available beyond a few months after stroke. We assessed self-managed computerised speech and language therapy (CSLT) as a means of providing more therapy than patients can access through usual care alone. Methods In this pragmatic, superiority, three-arm, individually randomised, single-blind, parallel group trial, patients were recruited from 21 speech and language therapy departments in the UK. Participants were aged 18 years or older and had been diagnosed with aphasia post-stroke at least 4 months before randomisation; they were excluded if they had another premorbid speech and language disorder caused by a neurological deficit other than stroke, required treatment in a language other than English, or if they were currently using computer-based word-finding speech therapy. Participants were randomly assigned (1:1:1) to either 6 months of usual care (usual care group), daily self-managed CSLT plus usual care (CSLT group), or attention control plus usual care (attention control group) with the use of computer-generated stratified blocked randomisation (randomly ordered blocks of sizes three and six, stratified by site and severity of word finding at baseline based on CAT Naming Objects test scores). Only the outcome assessors and trial statistician were masked to the treatment allocation. The speech and language therapists who were doing the outcome assessments were different from those informing participants about which group they were assigned to and from those delivering all interventions. The statistician responsible for generating the randomisation schedule was separate from those doing the analysis. Co-primary outcomes were the change in ability to retrieve personally relevant words in a picture naming test (with 10% mean difference in change considered a priori as clinically meaningful) and the change in functional communication ability measured by masked ratings of video-recorded conversations, with the use of Therapy Outcome Measures (TOMs), between baseline and 6 months after randomisation (with a standardised mean difference in change of 0·45 considered a priori as clinically meaningful). Primary analysis was based on the modified intention-to-treat (mITT) population, which included randomly assigned patients who gave informed consent and excluded those without 6-month outcome measures. Safety analysis included all participants. This trial has been completed and was registered with the ISRCTN, number ISRCTN68798818. Findings From Oct 20, 2014, to Aug 18, 2016, 818 patients were assessed for eligibility, of which 278 (34%) participants were randomly assigned (101 [36%] to the usual care group; 97 [35%] to the CSLT group; 80 [29%] to the attention control group). 86 patients in the usual care group, 83 in the CSLT group, and 71 in the attention control group...

Objectives To determine whether using a point-of-care cardiac biomarker panel would increase the rate of successful discharge home after emergency department assessment, and affect the use of cardiac tests and treatments, subsequent attendance at or admission to hospital and major adverse events. Design and setting Pragmatic multicentre randomised controlled trial in six acute hospitals in the UK. Participants Patients attending with acute chest pain due to suspected myocardial infarction (N¼2243).Interventions Diagnostic assessment using a point-ofcare biomarker panel consisting of creatine kinase, myocardial type, myoglobin and troponin I measured at baseline and 90 min compared with standard care without the point-of-care panel.

Objectives: Chest pain due to suspected myocardial infarction (MI) is responsible for many hospital admissions and consumes substantial health care resources. The Randomized Assessment of Treatment using Panel Assay of Cardiac markers (RATPAC) trial showed that diagnostic assessment using a point-of-care (POC) cardiac biomarker panel consisting of CK-MB, myoglobin, and troponin increased the proportion of patients successfully discharged after emergency department (ED) assessment. In this economic analysis, the authors aimed to determine whether POC biomarker panel assessment reduced health care costs and was likely to be cost-effective. Methods:The RATPAC trial was a multicenter individual patient randomized controlled trial comparing diagnostic assessment using a POC biomarker panel (CK-MB, myoglobin, and troponin, measured at baseline and 90 minutes) to standard care without the POC panel in patients attending six EDs with acute chest pain due to suspected MI (n = 2,243). Individual patient resource use data were collected from all participants up to 3 months after hospital attendance using self-completed questionnaires at 1 and 3 months and case note review. ED staff and POC testing costs were estimated through a microcosting study of 246 participants. Resource use was valued using national unit costs. Health utility was measured using the EQ-5D self-completed questionnaire, mailed at 1 and 3 months. Quality-adjusted life-years (QALYs) were calculated by the trapezium rule using the EQ-5D tariff values at all follow-up points. Mean costs per patient were compared between the two treatment groups. Cost-effectiveness was estimated in terms of probability of dominance and incremental cost per QALY.Results: Point-of-care panel assessment was associated with higher ED costs, coronary care costs, and cardiac intervention costs, but lower general inpatient costs. Mean costs per patient were £1217.14 (standard deviation [SD] ± 3164.93), or $1,987.14 (SD ± $4,939.25), with POC versus £1005.91 (SD ± £1907.55), or $1,568.64 (SD ± $2,975.78), with standard care (p = 0.056). Mean QALYs were 0.158 (SD ± 0.052) versus 0.161 (SD ± 0.056; p = 0.250). The probability of standard care being dominant (i.e., cheaper and more effective) was 0.888, while the probability of the POC panel being dominant was 0.004. These probabilities were not markedly altered by sensitivity analysis varying the costs of the POC panel and excluding intensive care costs.