Derek Bell

Trial of early, goal-directed resuscitation for septic shock.

BACKGROUND Early, goal-directed therapy (EGDT) is recommended in international guidelines for the resuscitation of patients presenting with early septic shock. However, adoption has been limited, and uncertainty about its effectiveness remains. METHODS We conducted a pragmatic randomized trial with an integrated cost-effectiveness analysis in 56 hospitals in England. Patients were randomly assigned to receive either EGDT (a 6-hour resuscitation protocol) or usual care. The primary clinical outcome was all-cause mortality at 90 days. RESULTS We enrolled 1260 patients, with 630 assigned to EGDT and 630 to usual care. By 90 days, 184 of 623 patients (29.5%) in the EGDT group and 181 of 620 patients (29.2%) in the usual-care group had died (relative risk in the EGDT group, 1.01; 95% confidence interval [CI], 0.85 to 1.20; P=0.90), for an absolute risk reduction in the EGDT group of -0.3 percentage points (95% CI, -5.4 to 4.7). Increased treatment intensity in the EGDT group was indicated by increased use of intravenous fluids, vasoactive drugs, and red-cell transfusions and reflected by significantly worse organ-failure scores, more days receiving advanced cardiovascular support, and longer stays in the intensive care unit. There were no significant differences in any other secondary outcomes, including health-related quality of life, or in rates of serious adverse events. On average, EGDT increased costs, and the probability that it was cost-effective was below 20%. CONCLUSIONS In patients with septic shock who were identified early and received intravenous antibiotics and adequate fluid resuscitation, hemodynamic management according to a strict EGDT protocol did not lead to an improvement in outcome. (Funded by the United Kingdom National Institute for Health Research Health Technology Assessment Programme; ProMISe Current Controlled Trials number, ISRCTN36307479.).

Systematic review of the application of the plan–do–study–act method to improve quality in healthcare

Background Plan–do–study–act (PDSA) cycles provide a structure for iterative testing of changes to improve quality of systems. The method is widely accepted in healthcare improvement; however there is little overarching evaluation of how the method is applied. This paper proposes a theoretical framework for assessing the quality of application of PDSA cycles and explores the consistency with which the method has been applied in peer-reviewed literature against this framework. Methods NHS Evidence and Cochrane databases were searched by three independent reviewers. Empirical studies were included that reported application of the PDSA method in healthcare. Application of PDSA cycles was assessed against key features of the method, including documentation characteristics, use of iterative cycles, prediction-based testing of change, initial small-scale testing and use of data over time. Results 73 of 409 individual articles identified met the inclusion criteria. Of the 73 articles, 47 documented PDSA cycles in sufficient detail for full analysis against the whole framework. Many of these studies reported application of the PDSA method that failed to accord with primary features of the method. Less than 20% (14/73) fully documented the application of a sequence of iterative cycles. Furthermore, a lack of adherence to the notion of small-scale change is apparent and only 15% (7/47) reported the use of quantitative data at monthly or more frequent data intervals to inform progression of cycles. Discussion To progress the development of the science of improvement, a greater understanding of the use of improvement methods, including PDSA, is essential to draw reliable conclusions about their effectiveness. This would be supported by the development of systematic and rigorous standards for the application and reporting of PDSAs.

Designing and implementing a COPD discharge care bundle

National surveys have revealed significant differences in patient outcomes following admission to hospital with acute exacerbation of COPD which are likely to be due to variations in care. We developed a care bundle, comprising a short list of evidence-based practices to be implemented prior to discharge for all patients admitted with this condition, based on a review of national guidelines and other relevant literature, expert opinion and patient consultation. Implementation was then piloted using action research methodologies with patient input. Actively involving staff was vital to ensure that the changes introduced were understood and the process followed. Implementation of a care bundle has the potential to produce a dramatic improvement in compliance with optimum health care practice.

Variability in management of early severe sepsis.

Objective A study was undertaken to characterise how doctors in emergency medicine (EM), acute medicine (AM) and critical care (ICU) in the UK, USA and Australia and New Zealand (ANZ) approach the initial resuscitative care of patients with severe sepsis. Methods In 2007, members on the mailing lists of UK, US and ANZ EM, ICU and AM specialist organisations were invited to answer an anonymous scenario-based online survey. Respondents described their management of a patient with pneumonia and signs of sepsis. Multiple-choice questions were based on the Surviving Sepsis Campaign (SSC) 6-hour resuscitation bundle guidelines while avoiding the specific terms “sepsis” and “SSC guidelines”. Results The response rate was 21% (2461/11 795). Only two respondents (0.1%) complied with all SSC resuscitation recommendations. Inter-specialty and inter-country variations included differences in reporting initial lactate measurement (ranging from 30% in US-EM to 79% in UK-EM), fluid resuscitation targeting a central venous pressure of 8–12 mm Hg (from 15% in ANZ-ICU to 60% in UK-EM), blood transfusion for a central venous oxygen saturation <70% and haematocrit <30% (from 15% in ANZ-ICU to 70% in US-EM and UK-EM) and insertion of invasive monitoring (intra-arterial catheter: 89% in UK-ICU vs 20% in US-EM; central venous catheter: 83% in UK-ICU vs 44% in US-EM). 81% of respondents identified at least one reason why they did not implement all the recommendations; the reasons varied by region and specialty. Conclusions Reported management of early sepsis varies between specialities and countries, and the responses do not follow SSC guidelines. Concerns relate to knowledge, attitudes and resources.

Patient and Public Views on Electronic Health Records and Their Uses in the United Kingdom: Cross-Sectional Survey

Background The development and implementation of electronic health records (EHRs) remains an international challenge. Better understanding of patient and public attitudes and the factors that influence overall levels of support toward EHRs is needed to inform policy. Objective To explore patient and public attitudes toward integrated EHRs used simultaneously for health care provision, planning and policy, and health research. Methods Cross-sectional questionnaire survey administered to patients and members of the public who were recruited from a stratified cluster random sample of 8 outpatient clinics of a major teaching hospital and 8 general practices in London (United Kingdom). Results 5331 patients and members of the public responded to the survey, with 2857 providing complete data for the analysis presented here. There were moderately high levels of support for integrated EHRs used simultaneously for health care provision, planning and policy, and health research (1785/2857, 62.47%), while 27.93% (798/2857) of participants reported being undecided about whether or not they would support EHR use. There were higher levels of support for specific uses of EHRs. Most participants were in favor of EHRs for personal health care provision (2563/2857, 89.71%), with 66.75% (1907/2857) stating that they would prefer their complete, rather than limited, medical history to be included. Of those “undecided” about integrated EHRs, 87.2% (696/798) were nevertheless in favor of sharing their full (373/798, 46.7%) or limited (323/798, 40.5%) records for health provision purposes. There were similar high levels of support for use of EHRs in health services policy and planning (2274/2857, 79.59%) and research (2325/2857, 81.38%), although 59.75% (1707/2857) and 67.10% (1917/2857) of respondents respectively would prefer their personal identifiers to be removed. Multivariable analysis showed levels of overall support for EHRs decreasing with age. Respondents self-identifying as Black British were more likely to report being undecided or unsupportive of national EHRs. Frequent health services users were more likely to report being supportive than undecided. Conclusions Despite previous difficulties with National Health Service (NHS) technology projects, patients and the public generally support the development of integrated EHRs for health care provision, planning and policy, and health research. This support, however, varies between social groups and is not unqualified; relevant safeguards must be in place and patients should be guided in their decision-making process, including increased awareness about the benefits of EHRs for secondary uses.

Renaissance of hospital generalists

Hospital medicine in the US and acute medicine in the UK are the fastest growing specialties in their countries. Robert M Wachter and Derek Bell examine the factors behind their rise and how the differing national healthcare systems have influenced their structure

Patient and public attitudes towards informed consent models and levels of awareness of Electronic Health Records in the UK

Highlights • Most participants would prefer to opt-in before their identifiable records are used.• Half of participants would share their de-identified records under implicit consent.• A low awareness of EHRs persists among participants.• Participants who were aware of EHRs were more willing to share de-identified data.• Awareness and consent expectations vary by socio-demographic characteristics.

The effect of applying NICE guidelines for the investigation of stable chest pain on out-patient cardiac services in the UK

BACKGROUND The National Institute for Health and Clinical Excellence (NICE) recently released guidelines for the investigation of chest pain of recent onset. There is no published data regarding their impact on out-patient cardiac services. AIM This study was undertaken to assess the likelihood of coronary artery disease (CAD) in Rapid Access Chest Pain Clinic (RACPC) patients and the resultant investigation burden if NICE guidance was applied. METHODS Five hundred and ninety-five consecutive patients attending two RACPCs over 6 months preceding release of the NICE guidelines [51% male; median age 55 (range 22-94) years] were risk stratified using NICE criteria and the resultant investigations evaluated. RESULTS One hundred and six (18%) patients had a likelihood of CAD <10%, 123 (21%) between 10% and 29%, 175 (29%) between 30% and 60%, 141 (24%) between 61% and 90% and 50 (8%) >90%. NICE would have recommended 443 (74%) patients for no cardiac investigation, 10 (2%) for cardiac computed tomography (CCT), 69 (12%) for functional cardiac testing and 73 (12%) for invasive angiography. Relative to existing practice, there would have been a trend towards reduced functional cardiac testing (-24%, P = 0.06), no significant change in CCT (43%, P = 0.436) and a significant increase in invasive angiography (508%, P < 0.001). The cost of investigations recommended by NICE would have been £15,881 greater than existing practice. CONCLUSION This study suggests patients attending RACPC will have a greater likelihood of CAD than predicted by NICE. Differences between recommended investigations and existing practice will guide investment in cardiac services. Individual hospitals should assess their RACPC cohorts prior to implementing the NICE guidelines.

Protocolised Management In Sepsis (ProMISe): a multicentre randomised controlled trial of the clinical effectiveness and cost-effectiveness of early, goal-directed, protocolised resuscitation for emerging septic shock.

BACKGROUND Early goal-directed therapy (EGDT) is recommended in international guidance for the resuscitation of patients presenting with early septic shock. However, adoption has been limited and uncertainty remains over its clinical effectiveness and cost-effectiveness. OBJECTIVES The primary objective was to estimate the effect of EGDT compared with usual resuscitation on mortality at 90 days following randomisation and on incremental cost-effectiveness at 1 year. The secondary objectives were to compare EGDT with usual resuscitation for requirement for, and duration of, critical care unit organ support; length of stay in the emergency department (ED), critical care unit and acute hospital; health-related quality of life, resource use and costs at 90 days and at 1 year; all-cause mortality at 28 days, at acute hospital discharge and at 1 year; and estimated lifetime incremental cost-effectiveness. DESIGN A pragmatic, open, multicentre, parallel-group randomised controlled trial with an integrated economic evaluation. SETTING Fifty-six NHS hospitals in England. PARTICIPANTS A total of 1260 patients who presented at EDs with septic shock. INTERVENTIONS EGDT (n = 630) or usual resuscitation (n = 630). Patients were randomly allocated 1 : 1. MAIN OUTCOME MEASURES All-cause mortality at 90 days after randomisation and incremental net benefit (at £20,000 per quality-adjusted life-year) at 1 year. RESULTS Following withdrawals, data on 1243 (EGDT, n = 623; usual resuscitation, n = 620) patients were included in the analysis. By 90 days, 184 (29.5%) in the EGDT and 181 (29.2%) patients in the usual-resuscitation group had died [p = 0.90; absolute risk reduction -0.3%, 95% confidence interval (CI) -5.4 to 4.7; relative risk 1.01, 95% CI 0.85 to 1.20]. Treatment intensity was greater for the EGDT group, indicated by the increased use of intravenous fluids, vasoactive drugs and red blood cell transfusions. Increased treatment intensity was reflected by significantly higher Sequential Organ Failure Assessment scores and more advanced cardiovascular support days in critical care for the EGDT group. At 1 year, the incremental net benefit for EGDT versus usual resuscitation was negative at -£725 (95% CI -£3000 to £1550). The probability that EGDT was more cost-effective than usual resuscitation was below 30%. There were no significant differences in any other secondary outcomes, including health-related quality of life, or adverse events. LIMITATIONS Recruitment was lower at weekends and out of hours. The intervention could not be blinded. CONCLUSIONS There was no significant difference in all-cause mortality at 90 days for EGDT compared with usual resuscitation among adults identified with early septic shock presenting to EDs in England. On average, costs were higher in the EGDT group than in the usual-resuscitation group while quality-adjusted life-years were similar in both groups; the probability that it is cost-effective is < 30%. FUTURE WORK The ProMISe (Protocolised Management In Sepsis) trial completes the planned trio of evaluations of EGDT across the USA, Australasia and England; all have indicated that EGDT is not superior to usual resuscitation. Recognising that each of the three individual, large trials has limited power for evaluating potentially important subgroups, the harmonised approach adopted provides the opportunity to conduct an individual patient data meta-analysis, enhancing both knowledge and generalisability. TRIAL REGISTRATION Current Controlled Trials ISRCTN36307479. 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. 19, No. 97. See the NIHR Journals Library website for further project information.

A pilot survey of junior doctors’ attitudes and awareness around medication review: time to change our educational approach?

Objectives Our aim was to explore junior doctors’ attitudes and awareness around concepts related to medication review, in order to find ways to change the culture for reviewing, altering and stopping inappropriate or unnecessary medicines. Having already demonstrated the value of team working with senior doctors and pharmacists and the use of a medication review tool, we are now looking to engage first year clinicians and undergraduates in the process. Method An online survey about medication review was distributed among all 42 foundation year one (FY1) doctors at the Chelsea and Westminster Hospital NHS Foundation Trust in November 2014. Descriptive statistics were used for analysis. Results Twenty doctors completed the survey (48%). Of those, 17 believed that it was the pharmacists duty to review medicines; and 15 of 20 stated the general practitioner (GP). Sixteen of 20 stated that they would consult a senior doctor first before stopping medication. Eighteen of 20 considered the GP and consultant to be responsible for alterations, rather than themselves. Sixteen of 20 respondents were not aware of the availability of a medication review tool. Seventeen of 20 felt that more support from senior staff would help them become involved with medication review. Conclusions Junior doctors report feeling uncomfortable altering mediations without consulting a senior first. They appear to be building confidence with prescribing in their first year but not about the medication review process or questioning the drugs already prescribed. Consideration should be given to what we have termed a ‘bottom-up’ educational approach to provide early experience of and change the culture around medication review, to include the education of undergraduate and foundation doctors and pharmacists.