The impact of general practitioners working in or alongside emergency departments: a rapid realist review.

OBJECTIVES: Worldwide, emergency healthcare systems are under intense pressure from ever-increasing demand and evidence is urgently needed to understand how this can be safely managed. An estimated 10%-43% of emergency department patients could be treated by primary care services. In England, this has led to a policy proposal and £100 million of funding (US$130 million), for emergency departments to stream appropriate patients to a co-located primary care facility so they are 'free to care for the sickest patients'. However, the research evidence to support this initiative is weak. DESIGN: Rapid realist literature review. SETTING: Emergency departments. INCLUSION CRITERIA: Articles describing general practitioners working in or alongside emergency departments. AIM: To develop context-specific theories that explain how and why general practitioners working in or alongside emergency departments affect: patient flow; patient experience; patient safety and the wider healthcare system. RESULTS: Ninety-six articles contributed data to theory development sourced from earlier systematic reviews, updated database searches (Medline, Embase, CINAHL, Cochrane DSR & CRCT, DARE, HTA Database, BSC, PsycINFO and SCOPUS) and citation tracking. We developed theories to explain: how staff interpret the streaming system; different roles general practitioners adopt in the emergency department setting (traditional, extended, gatekeeper or emergency clinician) and how these factors influence patient (experience and safety) and organisational (demand and cost-effectiveness) outcomes. CONCLUSIONS: Multiple factors influence the effectiveness of emergency department streaming to general practitioners; caution is needed in embedding the policy until further research and evaluation are available. Service models that encourage the traditional general practitioner approach may have shorter process times for non-urgent patients; however, there is little evidence that this frees up emergency department staff to care for the sickest patients. Distinct primary care services offering increased patient choice may result in provider-induced demand. Economic evaluation and safety requires further research. PROSPERO REGISTRATION NUMBER: CRD42017069741.

Patient, health service factors and variation in mortality following resuscitated out-of-hospital cardiac arrest in acute coronary syndrome: Analysis of the Myocardial Ischaemia National Audit Project.

AIMS: To determine patient and health service factors associated with variation in hospital mortality among resuscitated cases of out-of-hospital cardiac arrest (OHCA) with acute coronary syndrome (ACS). METHODS: In this cohort study, we used the Myocardial Ischaemia National Audit Project database to study outcomes in patients hospitalised with resuscitated OHCA due to ACS between 2003 and 2015 in the United Kingdom. We analysed variation in inter-hospital mortality and used hierarchical multivariable regression models to examine the association between patient and health service factors with hospital mortality. RESULTS: We included 17604 patients across 239 hospitals. Overall hospital mortality was 28.7%. In 94 hospitals that contributed at least 60 cases, mortality by hospital ranged from 10.7% to 66.3% (median 28.6%, IQR 23.2% to 39.1%)). Patient and health service factors explained 36.1% of this variation. After adjustment for covariates, factors associated with higher hospital mortality included increasing serum glucose, ST-Elevation myocardial infarction (STEMI) diagnosis, and initial admission to a primary percutaneous coronary intervention (pPCI) capable hospital. Hospital OHCA volume was not associated with mortality. The key modifiable factor associated with lower mortality was early reperfusion therapy in STEMI patients. CONCLUSION: There was wide variation in inter-hospital mortality following resuscitated OHCA due to ACS that was only partially explained by patient and health service factors. Hospital OHCA volume and pPCI capability were not associated with lower mortality. Early reperfusion therapy was associated with lower mortality in STEMI patients.

Anaphylaxis and Clinical Utility of Real-World Measurement of Acute Serum Tryptase in UK Emergency Departments.

BACKGROUND: British guidelines recommend that serial acute serum tryptase measurements be checked in all adults and a subset of children presenting with anaphylaxis. This is the first study reporting the clinical utility of acute serum tryptase in a "real-world" emergency department (ED) setting following the publication of the World Allergy Organization (WAO) criteria for anaphylaxis. OBJECTIVES: To (1) assess sensitivity, specificity, and positive and negative predictive values (PPV, NPV) of acute serum tryptase in anaphylaxis; (b) determine factors associated with higher acute serum tryptase levels; and (c) audit compliance of acute serum tryptase measurement in the ED. METHODS: The methods used were retrospective electronic search for ED admissions to 3 acute care hospitals in Birmingham, UK, with anaphylaxis in 2012 using wide search terms followed by scrutiny of electronic clinical records and application of the WAO diagnostic criteria for anaphylaxis. Patients with an acute serum tryptase measurement were included in the analysis. RESULTS: Acute serum tryptase level was measured in 141 of 426 (33.1%) cases. Mean time from the onset of symptoms to the measurement of acute serum tryptase level was 4 hours 42 minutes (SD ± 05:03 hours) and no patients had serial measurements conforming to British guidelines. Acute serum tryptase level of more than 12.4 ng/mL (75th centile) was associated with a sensitivity, specificity, PPV, and NPV of 28%, 88%, 0.93, and 0.17, respectively. Multiple regression analysis showed that male sex (odds ratio, 2.66; P = .003) and hypotension (odds ratio, 7.08; P = .001) predicted higher acute serum tryptase level. CONCLUSIONS: An acute serum tryptase level of more than 12.4 ng/mL in an ED setting carries high PPV and specificity, but poor sensitivity and NPV.

Prehospital randomised assessment of a mechanical compression device in out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised trial and economic evaluation.

BACKGROUND: Mechanical chest compression devices may help to maintain high-quality cardiopulmonary resuscitation (CPR), but little evidence exists for their effectiveness. We evaluated whether or not the introduction of Lund University Cardiopulmonary Assistance System-2 (LUCAS-2; Jolife AB, Lund, Sweden) mechanical CPR into front-line emergency response vehicles would improve survival from out-of-hospital cardiac arrest (OHCA). OBJECTIVE: Evaluation of the LUCAS-2 device as a routine ambulance service treatment for OHCA. DESIGN: Pragmatic, cluster randomised trial including adults with non-traumatic OHCA. Ambulance dispatch staff and those collecting the primary outcome were blind to treatment allocation. Blinding of the ambulance staff who delivered the interventions and reported initial response to treatment was not possible. We also conducted a health economic evaluation and a systematic review of all trials of out-of-hospital mechanical chest compression. SETTING: Four UK ambulance services (West Midlands, North East England, Wales and South Central), comprising 91 urban and semiurban ambulance stations. Clusters were ambulance service vehicles, which were randomly assigned (approximately 1 : 2) to the LUCAS-2 device or manual CPR. PARTICIPANTS: Patients were included if they were in cardiac arrest in the out-of-hospital environment. Exclusions were patients with cardiac arrest as a result of trauma, with known or clinically apparent pregnancy, or aged < 18 years. INTERVENTIONS: Patients received LUCAS-2 mechanical chest compression or manual chest compressions according to the first trial vehicle to arrive on scene. MAIN OUTCOME MEASURES: Survival at 30 days following cardiac arrest; survival without significant neurological impairment [Cerebral Performance Category (CPC) score of 1 or 2]. RESULTS: We enrolled 4471 eligible patients (1652 assigned to the LUCAS-2 device and 2819 assigned to control) between 15 April 2010 and 10 June 2013. A total of 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 (104/1652, 6.3%) and manual CPR groups [193/2819, 6.8%; adjusted odds ratio (OR) 0.86, 95% confidence interval (CI) 0.64 to 1.15]. Survival with a CPC score of 1 or 2 may have been worse in the LUCAS-2 group (adjusted OR 0.72, 95% CI 0.52 to 0.99). No serious adverse events were noted. The systematic review found no evidence of a survival advantage if mechanical chest compression was used. The health economic analysis showed that LUCAS-2 was dominated by manual chest compression. LIMITATIONS: There was substantial non-compliance in the LUCAS-2 arm. For 272 out of 1652 patients (16.5%), mechanical chest compression was not used for reasons that would not occur in clinical practice. We addressed this issue by using complier average causal effect analyses. We attempted to measure CPR quality during the resuscitation attempts of trial participants, but were unable to do so. CONCLUSIONS: There was no evidence of improvement in 30-day survival with LUCAS-2 compared with manual compressions. Our systematic review of recent randomised trials did not suggest that survival or survival without significant disability may be improved by the use of mechanical chest compression. FUTURE WORK: The use of mechanical chest compression for in-hospital cardiac arrest, and in specific circumstances (e.g. transport), has not yet been evaluated. TRIAI REGISTRATION: Current Controlled Trials ISRCTN08233942. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 11. See the NIHR Journals Library website for further project information.

Epidemiology and outcomes from out-of-hospital cardiac arrests in England.

INTRODUCTION: This study reports the epidemiology and outcomes from out-of-hospital cardiac arrest (OHCA) in England during 2014. METHODS: Prospective observational study from the national OHCA registry. The incidence, demographic and outcomes of patients who were treated for an OHCA between 1st January 2014 and 31st December 2014 in 10 English ambulance service (EMS) regions, serving a population of almost 54 million, are reported in accordance with Utstein recommendations. RESULTS: 28,729 OHCA cases of EMS treated cardiac arrests were reported (53 per 100,000 of resident population). The mean age was 68.6 (SD=19.6) years and 41.3% were female. Most (83%) occurred in a place of residence, 52.7% were witnessed by either the EMS or a bystander. In non-EMS witnessed cases, 55.2% received bystander CPR whilst public access defibrillation was used rarely (2.3%). Cardiac aetiology was the leading cause of cardiac arrest (60.9%). The initial rhythm was asystole in 42.4% of all cases and was shockable (VF or pVT) in 20.6%. Return of spontaneous circulation at hospital transfer was evident in 25.8% (n=6302) and survival to hospital discharge was 7.9%. CONCLUSION: Cardiac arrest is an important cause of death in England. With less than one in ten patients surviving, there is scope to improve outcomes. Survival rates were highest amongst those who received bystander CPR and public access defibrillation.

The System-Wide Effect of Real-Time Audiovisual Feedback and Postevent Debriefing for In-Hospital Cardiac Arrest: The Cardiopulmonary Resuscitation Quality Improvement Initiative.

OBJECTIVE: To evaluate the effect of implementing real-time audiovisual feedback with and without postevent debriefing on survival and quality of cardiopulmonary resuscitation quality at in-hospital cardiac arrest. DESIGN: A two-phase, multicentre prospective cohort study. SETTING: Three UK hospitals, all part of one National Health Service Acute Trust. PATIENTS: One thousand three hundred and ninety-five adult patients who sustained an in-hospital cardiac arrest at the study hospitals and were treated by hospital emergency teams between November 2009 and May 2013. INTERVENTIONS: During phase 1, quality of cardiopulmonary resuscitation and patient outcomes were measured with no intervention implemented. During phase 2, staff at hospital 1 received real-time audiovisual feedback, whereas staff at hospital 2 received real-time audiovisual feedback supplemented by postevent debriefing. No intervention was implemented at hospital 3 during phase 2. MEASUREMENTS AND MAIN RESULTS: The primary outcome was return of spontaneous circulation. Secondary endpoints included other patient-focused outcomes, such as survival to hospital discharge, and process-focused outcomes, such as chest compression depth. Random-effect logistic and linear regression models, adjusted for baseline patient characteristics, were used to analyze the effect of the interventions on study outcomes. In comparison with no intervention, neither real-time audiovisual feedback (adjusted odds ratio, 0.62; 95% CI, 0.31-1.22; p=0.17) nor real-time audiovisual feedback supplemented by postevent debriefing (adjusted odds ratio, 0.65; 95% CI, 0.35-1.21; p=0.17) was associated with a statistically significant improvement in return of spontaneous circulation or any process-focused outcome. Despite this, there was evidence of a system-wide improvement in phase 2, leading to improvements in return of spontaneous circulation (adjusted odds ratio, 1.87; 95% CI, 1.06-3.30; p=0.03) and process-focused outcomes. CONCLUSIONS: Implementation of real-time audiovisual feedback with or without postevent debriefing did not lead to a measured improvement in patient or process-focused outcomes at individual hospital sites. However, there was an unexplained system-wide improvement in return of spontaneous circulation and process-focused outcomes during the second phase of the study.

Mechanical versus manual chest compression for out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised controlled trial.

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.

Managing competing organizational priorities in clinical handover across organizational boundaries.

OBJECTIVES: Handover across care boundaries poses additional challenges due to the different professional, organizational and cultural backgrounds of the participants involved. This paper provides a qualitative account of how practitioners in emergency care attempt to align their different individual and organizational priorities and backgrounds when handing over patients across care boundaries (ambulance service to emergency department (ED), and ED to acute medicine). METHODS: A total of 270 clinical handovers were observed in three emergency care pathways involving five participating NHS organizations (two ambulance services and three hospitals). Half-day process mapping sessions were conducted for each pathway. Semi-structured interviews were carried out with 39 participants and analysed thematically. RESULTS: The management of patient flow and the fulfilment of time-related performance targets can create conflicting priorities for practitioners during handover. Practitioners involved in handover manage such competing organizational priorities through additional coordination effort and dynamic trade-offs. Practitioners perceive greater collaboration across departments and organizations, and mutual awareness of each other's goals and constraints as possible ways towards more sustainable improvement. CONCLUSION: Sustainable improvement in handover across boundaries in emergency care might require commitment by leaders from all parts of the local health economy to work as partners to establish a culture of integrated, patient-centred care.

Unscheduled return visits (URV) in adults to the emergency department (ED): a rapid evidence assessment policy review.

Unscheduled return visits (URV) to the emergency department (ED) may be an important quality indicator of performance of individual clinicians as well as organisations and systems responsible for the delivery of emergency care. The aim of this study was to perform a rapid evidence assessment policy-based literature review of studies that have looked at URVs presenting to the ED. A rapid evidence assessment using SCOPUS and PUBMED was used to identify articles looking at unplanned returns to EDs in adults; those relating to specific complaints or frequent attenders were not included. After exclusions, we identified 26 articles. We found a reported URV rate of between 0.4% and 43.9% with wide variation in the time period defined for a URV, which ranged from 24 h to undefined. Thematic analysis identified four broad subtypes of URVs: related to patient factors, to the illness, to the system or organisation and to the clinician. This review informed the development of national clinical quality indicators for England. URV rates may serve as an important indicator of quality performance within the ED. However, review of the literature shows major inconsistencies in the way URVs are defined and measured. Furthermore, the review has highlighted that there are potentially at least four subcategories of URVs (patient related, illness related, system related and clinician related). Further work is in progress to develop standardised definitions and methodologies that will allow comparable research and allow URVs to be used reliably as a quality indicator for the ED.

Emergency Care Handover (ECHO study) across care boundaries: the need for joint decision making and consideration of psychosocial history.

BACKGROUND: Inadequate handover in emergency care is a threat to patient safety. Handover across care boundaries poses particular problems due to different professional, organisational and cultural backgrounds. While there have been many suggestions for standardisation of handover content, relatively little is known about the verbal behaviours that shape handover conversations. This paper explores both what is communicated (content) and how this is communicated (verbal behaviours) during different types of handover conversations across care boundaries in emergency care. METHODS: Three types of interorganisational (ambulance service to emergency department (ED) in 'resuscitation' and 'majors' areas) and interdepartmental handover conversations (referrals to acute medicine) were audio recorded in three National Health Service EDs. Handover conversations were segmented into utterances. Frequency counts for content and language forms were derived for each type of handover using Discourse Analysis. Verbal behaviours were identified using Conversation Analysis. RESULTS: 203 handover conversations were analysed. Handover conversations involving ambulance services were predominantly descriptive (60%-65% of utterances), unidirectional and focused on patient presentation (75%-80%). Referrals entailed more collaborative talk focused on the decision to admit and immediate care needs. Across all types of handover, only 1.5%-5% of handover conversation content related to the patient's social and psychological needs. CONCLUSIONS: Handover may entail both descriptive talk aimed at information transfer and collaborative talk aimed at joint decision-making. Standardisation of handover needs to accommodate collaborative aspects and should incorporate communication of information relevant to the patient's social and psychological needs to establish appropriate care arrangements at the earliest opportunity.

Systemic reactions and anaphylaxis with an acute serum tryptase ≥14 µg/L: retrospective characterisation of aetiology, severity and adherence to National Institute of Health and Care Excellence (NICE) guidelines for serial tryptase measurements and specialist referral.

AIMS: To characterise patients with systemic reactions and anaphylaxis with an acute serum tryptase of ≥14 µg/L against recently published World Allergy Organisation (WAO) diagnostic criteria. To also perform a clinical audit to assess adherence to National Institute of Health and Care Excellence (NICE) guideline recommendations regarding serial tryptase measurements and specialist referral. METHODS: A systematic retrospective survey (2006-2010) was carried out (n=171; males=86; mean age±SD 48±20 years) and data were extracted from emergency department and specialist allergy clinic records. RESULTS: 34 patients (20%) had a grade 1 reaction, 61 (36%) grade 2, 46 (27%) grade 3 and 6 patients (4%) grade 4 (24 patients (13%) could not be graded due to lack of adequate clinical details) and 6% developed a biphasic response. Serial tryptase measurements were not available in 117 (69%) of the cohort. 97 (57%) patients were referred for specialist assessment, and 72 (74%) attended. 50% of cases were diagnosed with idiopathic systemic reactions/anaphylaxis and 28%, 14% and 8% triggered by drugs, foods and other allergies including disorders of mast cell overload, respectively. A weak positive correlation was detected between acute serum tryptase and severity. CONCLUSIONS: The correlation between acute serum tryptase and severity of anaphylaxis/systemic reactions is weak. A significant proportion of patients with raised acute serum tryptase had mild reactions which did not meet WAO criteria for anaphylaxis and this may reduce the specificity of the test. The commonest aetiology in this cohort was idiopathic followed by drug and food allergies. NICE guidelines relating to serial tryptase measurements and specialist referral were not followed, and there is an urgent need to raise the awareness among clinicians involved in the management of anaphylaxis.

The beta agonist lung injury trial prevention. A randomized controlled trial.

RATIONALE: Experimental studies suggest that pretreatment with ß-agonists might prevent acute lung injury (ALI). OBJECTIVES: To determine if in adult patients undergoing elective esophagectomy, perioperative treatment with inhaled ß-agonists effects the development of early ALI. METHODS: We conducted a randomized placebo-controlled trial in 12 UK centers (2008-2011). Adult patients undergoing elective esophagectomy were allocated to prerandomized, sequentially numbered treatment packs containing inhaled salmeterol (100 µg twice daily) or a matching placebo. Patients, clinicians, and researchers were masked to treatment allocation. The primary outcome was development of ALI within 72 hours of surgery. Secondary outcomes were ALI within 28 days, organ failure, adverse events, survival, and health-related quality of life. An exploratory substudy measured biomarkers of alveolar-capillary inflammation and injury. MEASUREMENTS AND MAIN RESULTS: A total of 179 patients were randomized to salmeterol and 183 to placebo. Baseline characteristics were similar. Treatment with salmeterol did not prevent early lung injury (32 [19.2%] of 168 vs. 27 [16.0%] of 170; odds ratio [OR], 1.25; 95% confidence interval [CI], 0.71-2.22). There was no difference in organ failure, survival, or health-related quality of life. Adverse events were less frequent in the salmeterol group (55 vs. 70; OR, 0.63; 95% CI, 0.39-0.99), predominantly because of a lower number of pneumonia (7 vs. 17; OR, 0.39; 95% CI, 0.16-0.96). Salmeterol reduced some biomarkers of alveolar inflammation and epithelial injury. CONCLUSION: Perioperative treatment with inhaled salmeterol was well tolerated but did not prevent ALI. Clinical trial registered with International Standard Randomized Controlled Trial Register (ISRCTN47481946) and European Union database of randomized Controlled Trials (EudraCT 2007-004096-19).

Minor head injury in children: evaluating written discharge advice provided by Scottish emergency departments.

OBJECTIVES: Emergency departments (EDs) routinely provide written information when a child with head injury (HI) is discharged home. This usually contains advice about recognizing signs of serious complications such as intracranial bleeding. This study evaluated the quality of discharge leaflets currently provided by Scottish emergency departments (EDs) by comparing them against written discharge advice recommended by the Scottish Intercollegiate Guideline Network (SIGN). METHODS: All 35 EDs in Scotland which treat children were asked to send a copy of the advice leaflet provided when a child with HI is discharged. Leaflets were evaluated by awarding scores for the inclusion of specific aspects of health information as recommended by SIGN. The inclusion of serious warning symptoms (maximum 20 points) and other advice on observation and help-seeking (maximum 21 points) was assessed. RESULTS: 34 EDs provided leaflets. The median score for including serious warning symptoms was 10/20. The median score for including advice regarding observation and when to seek help was 6.5/21. Several leaflets contained unclear or contradictory advice. CONCLUSION: Many leaflets did not include important information recommended by SIGN guidelines. There was considerable variation in the quality and clarity of written discharge advice provided. This may reduce the ability of parents to recognize rare but serious complications. It is recommended that a standardized HI information leaflet based on SIGN guidelines be used across all Scottish EDs.

Emergency department treatments and physiotherapy for acute whiplash: a pragmatic, two-step, randomised controlled trial.

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.

Randomized double-blind placebo-controlled trial of 40 mg/day of atorvastatin in reducing the severity of sepsis in ward patients (ASEPSIS Trial).

INTRODUCTION: Several observational studies suggest that statins modulate the pathophysiology of sepsis and may prevent its progression. The aim of this study was to determine if the acute administration of atorvastatin reduces sepsis progression in statin naïve patients hospitalized with sepsis. METHODS: A single centre phase II randomized double-blind placebo-controlled trial. Patients with sepsis were randomized to atorvastatin 40 mg daily or placebo for the duration of their hospital stay up to a maximum of 28-days. The primary end-point was the rate of sepsis progressing to severe sepsis during hospitalization. RESULTS: 100 patients were randomized, 49 to the treatment with atorvastatin and 51 to placebo. Patients in the atorvastatin group had a significantly lower conversion rate to severe sepsis compared to placebo (4% vs. 24% p = 0.007.), with a number needed to treat of 5. No significant difference in length of hospital stay, critical care unit admissions, 28-day and 12-month readmissions or mortality was observed. Plasma cholesterol and albumin creatinine ratios were significantly lower at day 4 in the atorvastatin group (p < 0.0001 and p = 0.049 respectively). No difference in adverse events between the two groups was observed (p = 0.238). CONCLUSIONS: Acute administration of atorvastatin in patients with sepsis may prevent sepsis progression. Further multi-centre trials are required to verify these findings. TRIAL REGISTRATION: International Standard Randomized Control Trial Registry ISRCTN64637517.

How reliable are clinical systems in the UK NHS? A study of seven NHS organisations.

BACKGROUND: It is well known that many healthcare systems have poor reliability; however, the size and pervasiveness of this problem and its impact has not been systematically established in the UK. The authors studied four clinical systems: clinical information in surgical outpatient clinics, prescribing for hospital inpatients, equipment in theatres, and insertion of peripheral intravenous lines. The aim was to describe the nature, extent and variation in reliability of these four systems in a sample of UK hospitals, and to explore the reasons for poor reliability. METHODS: Seven UK hospital organisations were involved; each system was studied in three of these. The authors took delivery of the systems' intended outputs to be a proxy for the reliability of the system as a whole. For example, for clinical information, 100% reliability was defined as all patients having an agreed list of clinical information available when needed during their appointment. Systems factors were explored using semi-structured interviews with key informants. Common themes across the systems were identified. RESULTS: Overall reliability was found to be between 81% and 87% for the systems studied, with significant variation between organisations for some systems: clinical information in outpatient clinics ranged from 73% to 96%; prescribing for hospital inpatients 82-88%; equipment availability in theatres 63-88%; and availability of equipment for insertion of peripheral intravenous lines 80-88%. One in five reliability failures were associated with perceived threats to patient safety. Common factors causing poor reliability included lack of feedback, lack of standardisation, and issues such as access to information out of working hours. CONCLUSIONS: Reported reliability was low for the four systems studied, with some common factors behind each. However, this hides significant variation between organisations for some processes, suggesting that some organisations have managed to create more reliable systems. Standardisation of processes would be expected to have significant benefit.