Derivation and validation of a risk adjustment model for predicting seven day mortality in emergency medical admissions: mixed prospective and retrospective cohort study

Objectives To derive and validate a risk adjustment model for predicting seven day mortality in emergency medical admissions, to test the value of including physiology and blood parameters, and to explore the constancy of the risk associated with each model variable across a range of settings

Effectiveness and cost-effectiveness of a telehealth intervention to support the management of long-term conditions:study protocol for two linked randomized controlled trials

As the population ages, more people are suffering from long-term health conditions (LTCs). Health services around the world are exploring new ways of supporting people with LTCs and there is great interest in the use of telehealth: technologies such as the Internet, telephone and home self-monitoring

Prioritising outcomes measures for ambulance service care: a three stage consensus study

Background Historically ambulance care quality and performance has been measured by response times rather than clinical need or effectiveness. This limits the evidence about the effectiveness of the care the ambulance service provides. The Pre-hospital Outcomes for Evidence Based Evaluation (PhOEBE) project is a 5 year research programme which aims to develop new ways of measuring the performance, quality and impact of ambulance service care that better reflect the care provided. Methods We held a 1 day consensus event with a multi-stakeholder group to identify and prioritise which features of ambulance service care are important and worth further development as measures of performance and quality. The day comprised a series of small group discussions to share opinions about measures identified from literature reviews and the opportunity for participants to add their ideas, together with a live vote to help identify and rank measures for further development. Time measures were considered in a separate online questionnaire. The results from the online questionnaire and Consensus Event were fed into a Delphi study. Results 43 participants attended the consensus event, representing a range of participant groups including patient and public, ambulance services, commissioners and policy groups. The top 5 outcome measures prioritised by the participants were: Accuracy of dispatch decisions; Completeness and accuracy of patient records; Accuracy of call taker identification of different conditions or needs (e.g. heart attack, stroke, suitable for nurse advice); Pain measurement and symptom relief; Patient experience. From the online survey of time measures the top 5 measures were Time of call to time of arrival at scene; Time symptoms start (e.g. chest pain) to time of treatment with balloon for heart attack; Time taken to answer the emergency call; Total time spent on scene; Incident or start of symptoms to calling the ambulance service Conclusions Using consensus methods we have identified a set of outcome measures that can potentially be used to measure the performance and quality of ambulance service care. Some of these measures fit with existing government targets, such as response times and time taken to answer the emergency call. However most measures are new ways of measuring ambulance service care and the importance of these measures and methods of measurement will be assessed as part of an on-going Delphi study

Explaining variation in emergency admissions: a mixed-methods study of emergency and urgent care systems

OBJECTIVE: To identify factors affecting variation in avoidable emergency admissions that are not usually identified in statistical regression. METHODS: As part of an ethnographic residual analysis, we compared six emergency and urgent care systems in England, interviewing 82 commissioners and providers of key emergency and urgent care services. RESULTS: There was variation between the six cases in how interviewees described three parts of their emergency and urgent care systems. First, interviewees' descriptions revealed variation in the availability of services before patients decided to attend emergency departments. Poor availability of general practice out of hours services in some of the cases reportedly made attendance at emergency departments the easier option for patients. Second, there was variation in how interviewees described patients being dealt with during their emergency department visit in terms of availability of senior review by specialists and in coding practices when patients were at risk of breaching the NHS's 4-hour waiting time target. Third, there was variability in services described as facilitating discharge home from emergency departments. In some cases, emergency department staff described dealing with multiple agencies in multiple localities outside the hospital, making admission the easier option. In other cases, proactive multidisciplinary rapid assessment teams were described as available to avoid admissions. Perceptions of resources available out of hours and the extent of integration between different health services, and between health and social services, also differed by case. CONCLUSIONS: This comparative case study approach identified further factors that may affect avoidable emergency admissions. Initiatives to improve GP out of hours services, make coding more accurately reflect patient experience, increase senior review in emergency departments, offer proactive multidisciplinary admission avoidance teams, improve the availability of out of hours care in the wider emergency and urgent care system, and increase service integration may reduce avoidable admissions. Evaluation of such initiatives would be necessary before wide-scale adoption

The multiple sclerosis risk sharing scheme monitoring study - early results and lessons for the future

Background: Risk sharing schemes represent an innovative and important approach to the problems of rationing and achieving cost-effectiveness in high cost or controversial health interventions. This study aimed to assess the feasibility of risk sharing schemes, looking at long term clinical outcomes, to determine the price at which high cost treatments would be acceptable to the NHS. Methods: This case study of the first NHS risk sharing scheme, a long term prospective cohort study of beta interferon and glatiramer acetate in multiple sclerosis ( MS) patients in 71 specialist MS centres in UK NHS hospitals, recruited adults with relapsing forms of MS, meeting Association of British Neurologists (ABN) criteria for disease modifying therapy. Outcome measures were: success of recruitment and follow up over the first three years, analysis of baseline and initial follow up data and the prospect of estimating the long term cost-effectiveness of these treatments. Results: Centres consented 5560 patients. Of the 4240 patients who had been in the study for a least one year, annual review data were available for 3730 (88.0%). Of the patients who had been in the study for at least two years and three years, subsequent annual review data were available for 2055 (78.5%) and 265 (71.8%) patients respectively. Baseline characteristics and a small but statistically significant progression of disease were similar to those reported in previous pivotal studies. Conclusion: Successful recruitment, follow up and early data analysis suggest that risk sharing schemes should be able to deliver their objectives. However, important issues of analysis, and political and commercial conflicts of interest still need to be addressed

Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial

Objective: To assess whether non-clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies. Design: Pragmatic, multicentre, randomised controlled trial. Setting: 42 general practices in three areas of England. Participants: Between 3 December 2012 and 23 July 2013 we recruited 641 adults aged 40 to 74 years with a 10 year cardiovascular disease risk of 20% or more, no previous cardiovascular event, at least one modifiable risk factor (systolic blood pressure ≥140 mm Hg, body mass index ≥30, current smoker), and access to a telephone, the internet, and email. Participants were individually allocated to intervention (n=325) or control (n=316) groups using automated randomisation stratified by site, minimised by practice and baseline risk score. Interventions: Intervention was the Healthlines service (alongside usual care), comprising regular telephone calls from trained lay health advisors following scripts generated by interactive software. Advisors facilitated self-management by supporting participants to use online resources to reduce risk factors, and sought to optimise drug use, improve treatment adherence, and encourage healthier lifestyles. The control group comprised usual care alone. Main outcome measures: The primary outcome was the proportion of participants responding to treatment, defined as maintaining or reducing their cardiovascular risk after 12 months. Outcomes were collected six and 12 months after randomisation and analysed masked. Participants were not masked. Results: 50% (148/295) of participants in the intervention group responded to treatment compared with 43% (124/291) in the control group (adjusted odds ratio 1.3, 95% confidence interval 1.0 to 1.9; number needed to treat=13); a difference possibly due to chance (P=0.08). The intervention was associated with reductions in blood pressure (difference in mean systolic −2.7 mm Hg (95% confidence interval −4.7 to −0.6 mm Hg), mean diastolic −2.8 (−4.0 to −1.6 mm Hg); weight −1.0 kg (−1.8 to −0.3 kg), and body mass index −0.4 (−0.6 to −0.1) but not cholesterol −0.1 (−0.2 to 0.0), smoking status (adjusted odds ratio 0.4, 0.2 to 1.0), or overall cardiovascular risk as a continuous measure (−0.4, −1.2 to 0.3)). The intervention was associated with improvements in diet, physical activity, drug adherence, and satisfaction with access to care, treatment received, and care coordination. One serious related adverse event occurred, when a participant was admitted to hospital with low blood pressure. Conclusions: This evidence based telehealth approach was associated with small clinical benefits for a minority of people with high cardiovascular risk, and there was no overall improvement in average risk. The Healthlines service was, however, associated with improvements in some risk behaviours, and in perceptions of support and access to care

The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

Abstract: Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised. This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process. The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist comprises seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text. The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits. In order to encourage its wide dissemination this article is freely accessible on the BMJ and Trials journal websites.“To maximise the benefit to society, you need to not just do research but do it well” Douglas G Altma

A randomised controlled trial and cost-effectiveness evaluation of "booster" interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods

Background: Systematic reviews have identified a range of brief interventions which increase physical activity in previously sedentary people. There is an absence of evidence about whether follow up beyond three months can maintain long term physical activity. This study assesses whether it is worth providing motivational interviews, three months after giving initial advice, to those who have become more active. Methods/Design: Study candidates (n = 1500) will initially be given an interactive DVD and receive two telephone follow ups at monthly intervals checking on receipt and use of the DVD. Only those that have increased their physical activity after three months (n = 600) will be randomised into the study. These participants will receive either a "mini booster" (n = 200), "full booster" (n = 200) or no booster (n = 200). The "mini booster" consists of two telephone calls one month apart to discuss physical activity and maintenance strategies. The "full booster" consists of a face-to-face meeting with the facilitator at the same intervals. The purpose of these booster sessions is to help the individual maintain their increase in physical activity. Differences in physical activity, quality of life and costs associated with the booster interventions, will be measured three and nine months from randomisation. The research will be conducted in 20 of the most deprived neighbourhoods in Sheffield, which have large, ethnically diverse populations, high levels of economic deprivation, low levels of physical activity, poorer health and shorter life expectancy. Participants will be recruited through general practices and community groups, as well as by postal invitation, to ensure the participation of minority ethnic groups and those with lower levels of literacy. Sheffield City Council and Primary Care Trust fund a range of facilities and activities to promote physical activity and variations in access to these between neighbourhoods will make it possible to examine whether the effectiveness of the intervention is modified by access to community facilities. A one-year integrated feasibility study will confirm that recruitment targets are achievable based on a 10% sample.Discussion: The choice of study population, study interventions, brief intervention preceding the study, and outcome measure are discussed