A. Niroshan Siriwardena

Pay-for-Performance in the United Kingdom: Impact of the Quality and Outcomes Framework—A Systematic Review

PURPOSE Primary care practices in the United Kingdom have received substantial financial rewards for achieving standards set out in the Quality and Outcomes Framework since April 2004. This article reviews the growing evidence for the impact of the framework on the quality of primary medical care. METHODS Five hundred seventy-five articles were identified by searching the MEDLINE, EMBASE, and PsycINFO databases, and from the reference lists of published reviews and articles. One hundred twenty-four relevant articles were assessed using a modified Downs and Black rating scale for 110 observational studies and a Critical Appraisal Skills Programme rating scale for 14 qualitative studies. Ninety-four studies were included in the review. RESULTS Quality of care for incentivized conditions during the first year of the framework improved at a faster rate than the preintervention trend and subsequently returned to prior rates of improvement. There were modest cost-effective reductions in mortality and hospital admissions in some domains. Differences in performance narrowed in deprived areas compared with nondeprived areas. Achievement for conditions outside the framework was lower initially and has worsened in relative terms since inception. Some doctors reported improved data recording and teamwork, and nurses enhanced specialist skills. Both groups believed that the person-centeredness of consultations and continuity were negatively affected. Patients’ satisfaction with continuity declined, with little change in other domains of patient experience. CONCLUSIONS Observed improvements in quality of care for chronic diseases in the framework were modest, and the impact on costs, professional behavior, and patient experience remains uncertain. Further research is needed into how to improve quality across different domains, while minimizing costs and any unintended adverse effects of payment for performance schemes. Health care organizations should remain cautious about the benefits of similar schemes.

Effectiveness of non-benzodiazepine hypnotics in treatment of adult insomnia: meta-analysis of data submitted to the Food and Drug Administration

Objectives To investigate the effectiveness of non-benzodiazepine hypnotics (Z drugs) and associated placebo responses in adults and to evaluate potential moderators of effectiveness in a dataset used to approve these drugs. Design Systematic review and meta-analysis. Data source US Food and Drug Administration (FDA). Study selection Randomised double blind parallel placebo controlled trials of currently approved Z drugs (eszopiclone, zaleplon, and zolpidem). Data extraction Change score from baseline to post-test for drug and placebo groups; drug efficacy analysed as the difference of both change scores. Weighted raw and standardised mean differences with their confidence intervals under random effects assumptions for polysomnographic and subjective sleep latency, as primary outcomes. Secondary outcomes included waking after sleep onset, number of awakenings, total sleep time, sleep efficiency, and subjective sleep quality. Weighted least square regression analysis was used to explain heterogeneity of drug effects. Data synthesis 13 studies containing 65 separate drug-placebo comparisons by type of outcome, type of drug, and dose were included. Studies included 4378 participants from different countries and varying drug doses, lengths of treatment, and study years. Z drugs showed significant, albeit small, improvements (reductions) in our primary outcomes: polysomnographic sleep latency (weighted standardised mean difference, 95% confidence interval −0.57 to −0.16) and subjective sleep latency (−0.33, −0.62 to −0.04) compared with placebo. Analyses of weighted mean raw differences showed that Z drugs decreased polysomnographic sleep latency by 22 minutes (−33 to −11 minutes) compared with placebo. Although no significant effects were found in secondary outcomes, there were insufficient studies reporting these outcomes to allow firm conclusions. Moderator analyses indicated that sleep latency was more likely to be reduced in studies published earlier, with larger drug doses, with longer duration of treatment, with a greater proportion of younger and/or female patients, and with zolpidem. Conclusion Compared with placebo, Z drugs produce slight improvements in subjective and polysomnographic sleep latency, especially with larger doses and regardless of type of drug. Although the drug effect and the placebo response were rather small and of questionable clinical importance, the two together produced to a reasonably large clinical response.

Feasibility of an Ambulance-Based Stroke Trial, and Safety of Glyceryl Trinitrate in Ultra-Acute Stroke The Rapid Intervention With Glyceryl Trinitrate in Hypertensive Stroke Trial (RIGHT, ISRCTN66434824)

Background and Purpose— The practicalities of doing ambulance-based trials where paramedics perform all aspects of a clinical trial involving patients with ultra-acute stroke have not been assessed. Methods— We performed a randomized controlled trial with screening, consent, randomization, and treatment performed by paramedics prior to hospitalization. Patients with probable ultra-acute stroke (<4 hours) and systolic blood pressure (SBP) >140 mm Hg were randomized to transdermal glyceryl trinitrate (GTN; 5 mg/24 hours) or none (blinding under gauze dressing) for 7 days with the first dose given by paramedics. The primary outcome was SBP at 2 hours. Results— Of a planned 80 patients, 41 (25 GTN, 16 no GTN) were enrolled >22 months with median age [interquartile range] 79 [16] years; men 22 (54%); SBP 168 [46]; final diagnosis: stroke 33 (80%) and transient ischemic attack 3 (7%). Time to randomization was 55 [75] minutes. After treatment with GTN versus no GTN, SBP at 2 hours was 153 [31] versus 174 [27] mm Hg, respectively, with difference −18 [30] mm Hg (P=0.030). GTN improved functional outcome with a shift in the modified Rankin Scale by 1 [3] point (P=0.040). The rates of death, 4 (16%) versus 6 (38%; P=0.15), and serious adverse events, 14 (56%) versus 10 (63%; P=0.75), did not differ between GTN and no GTN. Conclusions— Paramedics can successfully enroll patients with ultra-acute stroke into an ambulance-based trial. GTN reduces SBP at 2 hours and seems to be safe in ultra-acute stroke. A larger trial is needed to assess whether GTN improves functional outcome. Clinical Trial Registration— URL: http://www.controlled-trials.com/ISRCTN66434824/66434824. Unique identifier: 66434824.

Sleep restriction therapy for insomnia is associated with reduced objective total sleep time, increased daytime somnolence, and objectively impaired vigilance: implications for the clinical management of insomnia disorder.

STUDY OBJECTIVES To investigate whether sleep restriction therapy (SRT) is associated with reduced objective total sleep time (TST), increased daytime somnolence, and impaired vigilance. DESIGN Within-subject, noncontrolled treatment investigation. SETTING Sleep research laboratory. PARTICIPANTS Sixteen patients [10 female, mean age = 47.1 (10.8) y] with well-defined psychophysiological insomnia (PI), reporting TST ≤ 6 h. INTERVENTIONS Patients were treated with single-component SRT over a 4-w protocol, sleeping in the laboratory for 2 nights prior to treatment initiation and for 3 nights (SRT night 1, 8, 22) during the acute interventional phase. The psychomotor vigilance task (PVT) was completed at seven defined time points [day 0 (baseline), day 1,7,8,21,22 (acute treatment) and day 84 (3 mo)]. The Epworth Sleepiness Scale (ESS) was completed at baseline, w 1-4, and 3 mo. MEASUREMENT AND RESULTS Subjective sleep outcomes and global insomnia severity significantly improved before and after SRT. There was, however, a robust decrease in PSG-defined TST during acute implementation of SRT, by an average of 91 min on night 1, 78 min on night 8, and 69 min on night 22, relative to baseline (P < 0.001; effect size range = 1.60-1.80). During SRT, PVT lapses were significantly increased from baseline (at three of five assessment points, all P < 0.05; effect size range = 0.69-0.78), returning to baseline levels by 3 mo (P = 0.43). A similar pattern was observed for RT, with RTs slowing during acute treatment (at four of five assessment points, all P < 0.05; effect size range = 0.57-0.89) and returning to pretreatment levels at 3 mo (P = 0.78). ESS scores were increased at w 1, 2, and 3 (relative to baseline; all P < 0.05); by 3 mo, sleepiness had returned to baseline (normative) levels (P = 0.65). CONCLUSION For the first time we show that acute sleep restriction therapy is associated with reduced objective total sleep time, increased daytime sleepiness, and objective performance impairment. Our data have important implications for implementation guidelines around the safe and effective delivery of cognitive behavioral therapy for insomnia.

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.

Strategies to increase influenza vaccination rates: outcomes of a nationwide cross-sectional survey of UK general practice

Objective To identify practice strategies associated with higher flu vaccination rates in primary care. Design Logistic regression analysis of data from a cross-sectional online questionnaire. Setting 795 general practices across England. Participants 569 practice managers, 335 nursing staff and 107 general practitioners. Primary outcome measures Flu vaccination rates achieved by each practice in different groups of at-risk patients. Results 7 independent factors associated with higher vaccine uptake were identified. Having a lead staff member for planning the flu campaign and producing a written report of practice performance predicted an 8% higher vaccination rate for at-risk patients aged <65 years (OR 1.37, 95% CI 1.10 to 1.71). These strategies, plus sending a personal invitation to all eligible patients and only stopping vaccination when Quality and Outcomes Framework targets are reached, predicted a 7% higher vaccination rate (OR 1.45, 95% CI 1.10 to 1.92) in patients aged ≥65 years. Using a lead member of staff for identifying eligible patients, with either a modified manufacturers or in-house search programme for interrogating the practice IT system, independently predicted a 4% higher vaccination rate in patients aged ≥65 years (OR 1.22, 95% CI 1.06 to 1.41/OR 1.20, 95% CI 1.03 to 1.40). The provision of flu vaccine by midwives was associated with a 4% higher vaccination rate in pregnant women (OR 1.19, 95% CI 1.02 to 1.40). Conclusions Clear leadership, effective communication about performance and methods used to identify and contact eligible patients were independently associated with significantly higher rates of flu vaccination. Financial targets appear to incentivise practices to work harder to maximise seasonal influenza vaccine uptake. The strategies identified here could help primary care providers to substantially increase their seasonal flu vaccination rates towards or even above the Chief Medical Officers targets.

Room for improvement? Leadership, innovation culture and uptake of quality improvement methods in general practice

BACKGROUND Leadership and innovation are currently seen as essential elements for the development and maintenance of high-quality care. Little is known about the relationship between leadership and culture of innovation and the extent to which quality improvement methods are used in general practice. This study aimed to assess the relationship between leadership behaviour, culture of innovation and adoption of quality improvement methods in general practice. METHOD Self-administered postal questionnaires were sent to general practitioner quality improvement leads in one county in the UK between June and December 2007. The questionnaire consisted of background information, a 12-item scale to assess leadership behaviour, a seven-dimension self-rating scale for culture of innovation and questions on current use of quality improvement tools and techniques. RESULTS Sixty-three completed questionnaires (62%) were returned. Leadership behaviours were not commonly reported. Most practices reported a positive culture of innovation, featuring relationship most strongly, followed by targets and information but rated lower on other dimensions of rewards, risk and resources. There was a significant positive correlation between leadership behaviour and the culture of innovation (r = 0.57; P < 0.001). Apart from clinical audit and significant event analysis, quality improvement methods were not adopted by most participating practices. CONCLUSIONS Leadership behaviours were infrequently reported and this was associated with a limited culture of innovation in participating general practices. There was little use of quality improvement methods beyond clinical and significant event audit. Practices need support to enhance leadership skills, encourage innovation and develop quality improvement skills if improvements in health care are to accelerate.

Development and pilot of clinical performance indicators for English ambulance services

Introduction There is a compelling need to develop clinical performance indicators for ambulance services in order to move from indicators based primarily on response times and in light of the changing clinical demands on services. We report on progress on the national pilot of clinical performance indicators for English ambulance services. Method Clinical performance indicators were developed in five clinical areas: acute myocardial infarction, cardiac arrest, stroke (including transient ischaemic attack), asthma and hypoglycaemia. These were determined on the basis of common acute conditions presenting to ambulance services and in line with a previously published framework. Indicators were piloted by ambulance services in England and results were presented in tables and graphically using funnel (statistical process control) plots. Results Progress for developing, agreeing and piloting of indicators has been rapid, from initial agreement in May 2007 to completion of the pilot phase by the end of March 2008. The results of benchmarking of indicators are shown. The pilot has informed services in deciding the focus of their improvement programme in 2008–2009 and indicators have been adopted for national performance assessment of standards of prehospital care. Conclusion The pilot will provide the basis for further development of clinical indicators, benchmarking of performance and implementation of specific evidence-based interventions to improve care in areas identified for improvement. A national performance improvement registry will enable evaluation and sharing of effective improvement methods as well as increasing stakeholder and public access to information on the quality of care provided by ambulance services.

The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis

Summary Background Sleep difficulties might be a contributory causal factor in the occurrence of mental health problems. If this is true, improving sleep should benefit psychological health. We aimed to determine whether treating insomnia leads to a reduction in paranoia and hallucinations. Methods We did this single-blind, randomised controlled trial (OASIS) at 26 UK universities. University students with insomnia were randomly assigned (1:1) with simple randomisation to receive digital cognitive behavioural therapy (CBT) for insomnia or usual care, and the research team were masked to the treatment. Online assessments took place at weeks 0, 3, 10 (end of therapy), and 22. The primary outcome measures were for insomnia, paranoia, and hallucinatory experiences. We did intention-to-treat analyses. The trial is registered with the ISRCTN registry, number ISRCTN61272251. Findings Between March 5, 2015, and Feb 17, 2016, we randomly assigned 3755 participants to receive digital CBT for insomnia (n=1891) or usual practice (n=1864). Compared with usual practice, the sleep intervention at 10 weeks reduced insomnia (adjusted difference 4·78, 95% CI 4·29 to 5·26, Cohens d=1·11; p<0·0001), paranoia (−2·22, −2·98 to −1·45, Cohens d=0·19; p<0·0001), and hallucinations (−1·58, −1·98 to −1·18, Cohens d=0·24; p<0·0001). Insomnia was a mediator of change in paranoia and hallucinations. No adverse events were reported. Interpretation To our knowledge, this is the largest randomised controlled trial of a psychological intervention for a mental health problem. It provides strong evidence that insomnia is a causal factor in the occurrence of psychotic experiences and other mental health problems. Whether the results generalise beyond a student population requires testing. The treatment of disrupted sleep might require a higher priority in mental health provision. Funding Wellcome Trust.

Severe hypoglycaemia requiring emergency medical assistance by ambulance services in the East Midlands: a retrospective study.

AIMS To report the characteristics and treatment of individuals requiring emergency ambulance services for severe hypoglycaemia and estimate associated provider costs. METHODS Retrospective analysis of routinely collected data collected by the East Midlands Ambulance Trust, UK, of episodes of severe hypoglycaemia attended by emergency ambulance services during a four-month period. Standard clinical measures, response time, on-site treatment and transportation were recorded and ambulance services costs calculated. RESULTS 90,435 emergency calls were recorded, 523 (0.6%) for severe hypoglycaemia, equating to an incidence of to 2.76 per 100 patient years; 74% of individuals were insulin-treated, 28% of events occurred nocturnally (00:00-07:59), and 32% were transported to hospital. Higher respiratory rate was a positive predictor (p=0.03), whereas higher post treatment blood glucose (p=0.05) and insulin treatment (p<0.01) were negative predictors of transport to hospital. Median treatment costs for individuals transported and not transported to hospital were £92 and £176 respectively. CONCLUSIONS Most cases of severe hypoglycaemia requiring assistance from emergency ambulance services are successfully treated at the scene. Individuals not responding to treatment or were non insulin-treated were more likely to be transported to hospital. Further studies are needed to evaluate the effect of prehospital ambulance care by treatment and diabetes type on subsequent outcomes.