Elizabeth Cross

Randomised controlled trial and economic evaluation of a chest pain observation unit compared with routine care

Abstract 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.

The Randomised Assessment of Treatment using Panel Assay of Cardiac Markers (RATPAC) trial: a randomised controlled trial of point-of-care cardiac markers in the emergency department

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 (N=2243). Interventions Diagnostic assessment using a point-of-care biomarker panel consisting of creatine kinase, myocardial type, myoglobin and troponin I measured at baseline and 90u2005min compared with standard care without the point-of-care panel. Main outcome measures The primary outcome was successful discharge home, defined as having left hospital or awaiting transport home by 4u2005h after attendance and no major adverse events up to 3u2005months. Secondary outcome measures included length of stay, use of coronary care, cardiac interventions and inpatient beds, emergency department attendances, subsequent admissions, outpatient visits and major adverse events. Results Point-of-care panel assessment was associated with an increased rate of successful discharge (358/1125 (32%) vs 146/1118 (13%); OR 3.81, 95% CI 3.01 to 4.82; p<0.001), reduced median length of initial hospital stay (8.8 vs 14.2u2005h; p<0.001) and greater use of coronary care (50/1125 (4.0%) vs 31/1118 (3.0%); p=0.041), but no difference in mean length of initial stay (29.6 vs 31.7u2005h; p=0.462), mean inpatient days over follow-up (1.8 vs 1.7; p=0.815) or major adverse events (36 (3%) vs 26 (2%); OR 1.31, 95% CI 0.78 to 2.20; p=0.313). Conclusions Point-of-care panel assessment increases successful discharge home and reduces median length of stay, but does not alter overall hospital bed use. Trial registration Current controlled trials ISRCTN37823923.

SABRE: a multicentre randomised control trial of nebulised hypertonic saline in infants hospitalised with acute bronchiolitis

Aim Acute 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. Methods Infants 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. Results A 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. Conclusion This study does not support the use of nebulised HS in the treatment of acute bronchiolitis over usual care with minimal handlings. ClinicalTrials.gov registration number NCT01469845.

Effectiveness and safety of chest pain assessment to prevent emergency admissions: ESCAPE cluster randomised trial

Objective To determine whether introducing chest pain unit care reduces emergency admissions without increasing reattendances and admissions over the next 30 days. Design Cluster randomised before and after intervention trial. Setting 14 diverse acute hospitals in the United Kingdom. Participants Patients attending the emergency department with acute chest pain during the year before and the year after the intervention started. Intervention Establishment of chest pain unit care compared with continuation of routine care. Main outcome measures Proportion of chest pain attendances resulting in admission; reattendances and admissions over the next 30 days; daily emergency medical admissions (all causes); and proportion of emergency department attendances with chest pain. Results The introduction of chest pain unit care was associated with weak evidence of an increase in emergency department attendances with chest pain (16% v 3.5%; P=0.08); no change in the proportion of chest pain attendances resulting in admission (odds ratio 0.998, 95% confidence interval 0.940 to 1.059; P=0.945); small increases in the proportion reattending (odds ratio 1.10, 1.00 to 1.21; P=0.036) or being admitted (1.30, 0.97 to 1.74; P=0.083) over the next 30 days; and evidence of increased daily medical admissions (1.7 per day, 95% confidence interval 0.8 to 2.5; P<0.001). However, this last finding was highly sensitive to changes in the method used to handle missing data. Conclusion The introduction of chest pain unit care did not reduce the proportion of patients with chest pain admitted and may have been associated with increased emergency department attendances with chest pain. Trial registration Current Controlled Trials ISRCTN55318418.

The RATPAC (Randomised Assessment of Treatment using Panel Assay of Cardiac markers) trial: a randomised controlled trial of point-of-care cardiac markers in the emergency department.

OBJECTIVESnTo evaluate the clinical effectiveness and cost-effectiveness of using a point-of-care cardiac marker panel in patients presenting to the emergency department (ED) with suspected but not proven acute myocardial infarction (AMI).nnnDESIGNnMulticentre pragmatic open randomised controlled trial and economic evaluation.nnnSETTINGnSix acute hospital EDs in the UK.nnnPARTICIPANTSnAdults presenting to hospital with chest pain due to suspected but not proven myocardial infarction, and no other potentially serious alternative pathology or comorbidity.nnnINTERVENTIONSnParticipants were allocated using an online randomisation system to receive either (1) diagnostic assessment using the point-of-care biochemical marker panel or (2) conventional diagnostic assessment without the panel. All tests and treatments other than the panel were provided at the discretion of the clinician.nnnMAIN OUTCOME MEASURESnThe primary outcome was the proportion of patients successfully discharged home after ED assessment, defined as patients who had (1) either left the hospital or were awaiting transport home with a discharge decision having been made at 4 hours after initial presentation and (2) suffered no major adverse event (as defined below) during the following 3 months. Secondary outcomes included length of initial hospital stay and total inpatient days over 3 months, and major adverse events (death, non-fatal AMI, life-threatening arrhythmia, emergency revascularisation or hospitalisation for myocardial ischaemia). Economic analysis estimated mean costs and quality-adjusted life-years (QALYs), and then estimated the probability of cost-effectiveness assuming willingness to pay of £20,000 per QALY gained.nnnRESULTSnWe randomised 1132 participants to point of care and 1131 to standard care, and analysed 1125 and 1118, respectively [mean age 54.5 years, 1307/2243 (58%) male and 269/2243 (12%) with known coronary heart disease (CHD)]. In the point-of-care group 358/1125 (32%) were successfully discharged compared with 146/1118 (13%) in the standard-care group [odds ratio (OR) adjusted for age, gender and history of CHD 3.81; 95% confidence interval (CI) 3.01 to 4.82, p < 0.001]. Mean length of the initial hospital stay was 29.6 hours versus 31.8 hours (mean difference = 2.1 hours; 95% CI -3.7 to 8.0 hours, p = 0.462), while median length of initial hospital stay was 8.8 hours versus 14.2 hours (p < 0.001). More patients in the point-of-care group had no inpatient days recorded during follow-up (54% vs 40%, p < 0.001), but mean inpatient days did not differ between the two groups (1.8 vs 1.7, p = 0.815). More patients in the point-of-care group were managed on coronary care [50/1125 (4%) vs 31/1118 (3%), p = 0.041]. There were 36 (3%) patients with major adverse events in the point-of-care group and 26 (2%) in the standard-care group (adjusted OR 1.31; 95% CI 0.78 to 2.20, p = 0.313). Mean costs per patient were £1217 with point-of-care versus £1006 with standard care (p = 0.056), while mean QALYs were 0.158 versus 0.161 (p = 0.250). The probability of standard care being dominant (i.e. cheaper and more effective) was 0.888.nnnCONCLUSIONSnPoint-of-care testing increases the proportion of patients successfully discharged home and reduces the median (but not mean) length of hospital stay. It is more expensive than standard care and unlikely to be considered cost-effective.nnnTRIAL REGISTRATIONnCurrent Controlled Trials ISRCTN37823923.nnnFUNDINGnThis project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 15, No. 23. See the HTA programme website for further project information.

Cost‐effectiveness of Point‐of‐care Biomarker Assessment for Suspected Myocardial Infarction: The Randomized Assessment of Treatment Using Panel Assay of Cardiac Markers (RATPAC) Trial

OBJECTIVESnChest 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.nnnMETHODSnThe 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.nnnRESULTSnPoint-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

Rationing in the emergency department: the good, the bad, and the unacceptable

1,987.14 (SD ±

Patient satisfaction with chest pain unit care: findings from the Effectiveness and Safety of Chest Pain Assessment to Prevent Emergency Admissions (ESCAPE) cluster randomised trial

4,939.25), with POC versus £1005.91 (SD ±£1907.55), or

Saline in Acute Bronchiolitis RCT and Economic evaluation: hypertonic saline in acute bronchiolitis – randomised controlled trial and systematic review

1,568.64 (SD ±

Negotiating excess treatment costs in a clinical research trial: the good, the bad and the innovative

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.nnnCONCLUSIONSnPoint-of-care panel assessment does not reduce costs despite reducing admissions and may even increase costs. It is unlikely to be considered a cost-effective use of health care resources.