Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial.

BACKGROUND: Insomnia is prevalent and distressing but access to the first-line treatment, cognitive behavioural therapy (CBT), is extremely limited. We aimed to assess the clinical and cost-effectiveness of sleep restriction therapy, a key component of CBT, which has the potential to be widely implemented. METHODS: We did a pragmatic, superiority, open-label, randomised controlled trial of sleep restriction therapy versus sleep hygiene. Adults with insomnia disorder were recruited from 35 general practices across England and randomly assigned (1:1) using a web-based randomisation programme to either four sessions of nurse-delivered sleep restriction therapy plus a sleep hygiene booklet or a sleep hygiene booklet only. There was no restriction on usual care for either group. Outcomes were assessed at 3 months, 6 months, and 12 months. The primary endpoint was self-reported insomnia severity at 6 months measured with the insomnia severity index (ISI). The primary analysis included participants according to their allocated group and who contributed at least one outcome measurement. Cost-effectiveness was evaluated from the UK National Health Service and personal social services perspective and expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The trial was prospectively registered (ISRCTN42499563). FINDINGS: Between Aug 29, 2018, and March 23, 2020 we randomly assigned 642 participants to sleep restriction therapy (n=321) or sleep hygiene (n=321). Mean age was 55·4 years (range 19-88), with 489 (76·2%) participants being female and 153 (23·8%) being male. 580 (90·3%) participants provided data for at least one outcome measurement. At 6 months, mean ISI score was 10·9 (SD 5·5) for sleep restriction therapy and 13·9 (5·2) for sleep hygiene (adjusted mean difference -3·05, 95% CI -3·83 to -2·28; p<0·0001; Cohen's d -0·74), indicating that participants in the sleep restriction therapy group reported lower insomnia severity than the sleep hygiene group. The incremental cost per QALY gained was £2076, giving a 95·3% probability that treatment was cost-effective at a cost-effectiveness threshold of £20 000. Eight participants in each group had serious adverse events, none of which were judged to be related to intervention. INTERPRETATION: Brief nurse-delivered sleep restriction therapy in primary care reduces insomnia symptoms, is likely to be cost-effective, and has the potential to be widely implemented as a first-line treatment for insomnia disorder. FUNDING: The National Institute for Health and Care Research Health Technology Assessment Programme.

Pre-hospital transdermal glyceryl trinitrate for transient ischaemic attack: Data from the RIGHT-2 trial.

BACKGROUND AND PURPOSE: Ambulance trials assessing interventions in suspected stroke patients will recruit patients with currently active symptoms that will resolve into transient ischaemic attack (TIA). The safety and efficacy of glyceryl trinitrate (GTN) in the pre-specified subgroup of patients with TIA in the Rapid Intervention with Glyceryl Trinitrate in Hypertensive Stroke Trial 2 (RIGHT-2) was assessed. METHODS: RIGHT-2 was a pre-hospital-initiated multicentre randomized sham-controlled blinded-endpoint trial that randomized patients with presumed ultra-acute stroke within 4 h of symptom onset to transdermal GTN or sham. Final diagnosis was determined by site investigators. The primary outcome was a shift in modified Rankin Scale (mRS) scores at 90 days analysed using ordinal logistic regression reported as adjusted common odds ratio with 95% confidence intervals (CIs). Secondary outcomes included death or dependence (mRS >2). RESULTS: In all, 109 of 1149 (9.5%) patients had a final diagnosis of TIA (GTN 57, sham 52) with mean age 73 (SD 13) years, 19 (17.4%) had pre-morbid mRS >2, and onset to randomization was 80 min (interquartile range 49, 105). GTN lowered blood pressure by 7.4/5.2 mmHg compared with sham by hospital arrival. At day 90, GTN had no effect on shift in mRS scores (common odds ratio for increased dependence 1.47, 95% CI 0.70-3.11) but was associated with increased death or dependence (mRS >2): GTN 29 (51.8%) versus sham 23 (46.9%), odds ratio 3.86 (95% CI 1.09-13.59). CONCLUSIONS: Pre-hospital ultra-acute transdermal GTN did not improve overall functional outcome in patients with investigator-diagnosed TIA compared with sham treatment.

Perceptions and experiences of trainers and trainees of UK workplace-based assessment for general practice licensing: a mixed methods survey.

BACKGROUND: Workplace-Based Assessment (WPBA) forms a major component of the UK General Practitioner (GP) licensing, together with knowledge and clinical skills examination. WPBA includes Case-based Discussion, Consultation Observation Tool, Mini-Consultation Exercise, Multisource Feedback, Patient Satisfaction Questionnaire, Clinical Examination and Procedural Skills, Clinical Supervisor's Report, and Educational Supervisor Review. We aimed to investigate GP trainees' and trainers' perceptions and experiences of WPBA regarding validity and fairness. METHODS: We used a national online survey, with Likert-scaled and free-text responses, to a convenience sample of GP trainees and trainers, on perceptions and experiences of WPBA. Analysis included descriptive statistics, scale development, and regression models to investigate factors associated with attitudes towards WPBA, with thematic analysis of free text responses supported by NVivo 12. RESULTS: There were 2,088 responses from 1,176 trainees and 912 trainers. Both groups were generally positive towards WPBA, with trainers more positive or similar to trainees towards individual assessments. In a multivariable regression model, accounting for sex, ethnicity and country of primary medical qualification, trainees were significantly less positive (p < 0.001) while international medical graduates (IMGs) trained outside the European Economic Area (EEA) were significantly more (p < 0.001) positive towards WPBA. Qualitative analysis revealed varying concerns about validity and relevance, assessment burden, potential for bias, fairness to protected characteristics groups, gaps in assessment, and perceptions of individual assessments. DISCUSSION: Trainers' greater positivity towards elements of WPBA accords with their role as assessors. Despite concerns about bias, IMGs from outside the EEA were significantly more positive towards WPBA.

A systematic review of ambulance service-based randomised controlled trials in stroke.

BACKGROUND: Treatment for stroke is time-dependent, and ambulance services play a vital role in the early recognition, assessment and transportation of stroke patients. Innovations which begin in ambulance services to expedite delivery of treatments for stroke are developing. However, research delivery in ambulance services is novel, developing and not fully understood. AIMS: To synthesise literature encompassing ambulance service-based randomised controlled interventions for acute stroke with consideration to the characteristics of the type of intervention, consent modality, time intervals and issues unique to research delivery in ambulance services. Online searches of MEDLINE, EMBASE, Web of Science, CENTRAL and WHO IRCTP databases and hand searches identified 15 eligible studies from 538. Articles were heterogeneous in nature and meta-analysis was partially available as 13 studies reported key time intervals, but terminology varied. Randomised interventions were evident across all points of contact with ambulance services: identification of stroke during the call for help, higher dispatch priority assigned to stroke, on-scene assessment and clinical interventions, direct referral to comprehensive stroke centres and definitive care delivery at scene. Consent methods ranged between informed patient, waiver and proxy modalities with country-specific variation. Challenges unique to the prehospital setting comprise the geographical distribution of ambulance resources, low recruitment rates, prolonged recruitment phases, management of investigational medicinal product and incomplete datasets. CONCLUSION: Research opportunities exist across all points of contact between stroke patients and ambulance services, but randomisation and consent remain novel. Early collaboration and engagement between trialists and ambulance services will alleviate some of the complexities reported. REGISTRATION NUMBER: PROSPERO 2018CRD42018075803.

Migrant GPs and patients: a cross-sectional study of practice characteristics, patient experiences and migration concordance.

OBJECTIVE: To investigate practice type and location of native and immigrant general practitioners (GPs); effects of migration status concordance between GPs and patients on experiences of patients in key areas of primary care quality and discrimination. DESIGN AND SETTING: Secondary analysis of GP and patient survey data from QUALICOPC (Quality and Costs of Primary Care), a cross-sectional study of GPs and their patients in 34 countries, performed between 2011 and 2013. MAIN OUTCOME MEASURES: We explored practice type and location of native and immigrant GPs and the experiences of native patients and patients with a migration background of communication, continuity, comprehensiveness, accessibility, and discrimination, using multilevel analysis. Concordance was modelled as a cross-level interaction between migration status of GPs and patients. RESULTS: Percentages of immigrant GPs varied widely. In Europe, this was highest in England and Luxemburg (40% of GPs born abroad) and lowest in Bulgaria and Romania (1%). The practice population of immigrant GPs more often included an above average proportion of people from ethnic minorities. There were no differences in main effects of patient experiences following a visit to an immigrant or native GP, in four core areas of primary care or in discrimination. However, people from first-generation migrant background more often experienced discrimination, in particular when visiting a native GP. CONCLUSION: Patient experiences did not vary with GPs' migration status. Although experience of discrimination was uncommon, first-generation migrant patients experienced more discrimination. Primary care should provide non-discriminatory care, through GP awareness of unconscious bias and training to address this. Key messagesThere were large differences in percentage of migrant GPs between countries.Migrant GPs' practices had an above average proportion of people from ethnic minorities.In general, patients' experienced discrimination from GPs and practice staff was low, but first-generation migrant patients more often experienced discrimination.First-generation migrant patients more often experienced discrimination when they visited a native GP.

Perceptions and experiences of medical student first responders: a mixed methods study.

CONTEXT: Medical Student First Responders (MSFRs) are volunteers who respond to emergency calls, managing patients before ambulance staff attend. The MSFR role provides opportunities to manage acutely unwell patients in the prehospital environment, not usually offered as part of formal undergraduate medical education. There are few previous studies describing activities or experiences of MSFRs or exploring the potential educational benefits. We aimed to investigate the activity of MSFRs and explore their experiences, particularly from an educational perspective. METHODS: We used a mixed methods design, combining quantitative analysis of ambulance dispatch data with qualitative semi-structured interviews of MSFRs. Dispatch data were from South Central and East Midlands Ambulance Service NHS Trusts from 1st January to 31st December 2019. Using propensity score matching, we compared incidents attended by MSFRs with those attended by other Community First Responders (CFRs) and ambulance staff. We interviewed MSFRs from five English (UK) medical schools in those regions about their experiences and perceptions and undertook thematic analysis supported by NVivo 12. RESULTS: We included 1,939 patients (median age 58.0 years, 51% female) attended by MSFRs. Incidents attended were more urgent category calls (category 1 n = 299, 14.9% and category 2 n = 1,504, 77.6%), most commonly for chest pain (n = 275, 14.2%) and shortness of breath (n = 273, 14.1%). MSFRs were less likely to attend patients of white ethnicity compared to CFRs and ambulance staff, and more likely to attend incidents in areas of higher socioeconomic deprivation (IMD - index of multiple deprivation) (p < 0.05). Interviewees (n = 16) consistently described positive experiences which improved their clinical and communication skills. CONCLUSION: MSFRs' attendance at serious medical emergencies provide a range of reported educational experiences and benefits. Further studies are needed to explore whether MSFR work confers demonstrable improvements in educational or clinical performance.

People with diabetes and ambulance staff perceptions of a booklet-based intervention for diabetic hypoglycaemia, "Hypos can strike twice": a mixed methods process evaluation.

BACKGROUND: Hypoglycaemia is a potentially serious condition, characterised by lower-than-normal blood glucose levels, common in people with diabetes (PWD). It can be prevented and self-managed if expert support, such as education on lifestyle and treatment, is provided. Our aim was to conduct a process evaluation to investigate how ambulance staff and PWD perceived the "Hypos can strike twice" booklet-based ambulance clinician intervention, including acceptability, understandability, usefulness, positive or negative effects, and facilitators or barriers to implementation. METHODS: We used an explanatory sequential design with a self-administered questionnaire study followed by interviews of people with diabetes and ambulance staff. We followed the Medical Research Council framework for process evaluations of complex interventions to guide data collection and analysis. Following descriptive analysis (PWD and staff surveys), exploratory factor analysis was conducted to identify staff questionnaire subscales and multiple regression models were fitted to identify demographic predictors of overall and subscale scores. RESULTS: 113 ambulance staff members and 46 PWD completed the survey. We conducted interviews with four ambulance staff members and five PWD who had been attended by an ambulance for a hypoglycaemic event. Based on surveys and interviews, there were positive attitudes to the intervention from both ambulance staff and PWD. Although the intervention was not always implemented, most staff members and PWD found the booklet informative, easy to read and to use or explain. PWD who completed the survey reported that receiving the booklet reminded and/or encouraged them to test their blood glucose more often, adjust their diet, and have a discussion/check up with their diabetes consultant. Interviewed PWD felt that the booklet intervention would be more valuable to less experienced patients or those who cannot manage their diabetes well. Overall, participants felt that the intervention could be beneficial, but were uncertain about whether it might help prevent a second hypoglycaemic event and/or reduce the number of repeat ambulance attendances. CONCLUSIONS: The 'Hypos may strike twice' intervention, which had demonstrable reductions in repeat attendances, was found to be feasible, acceptable to PWD and staff, prompting reported behaviour change and help-seeking from primary care. TRIAL REGISTRATION: Registered with ClinicalTrials.gov: NCT04243200 on 27 January 2020.

Understanding how Eastern European migrants use and experience UK health services: a systematic scoping review.

BACKGROUND: The UK has experienced significant immigration from Eastern Europe following European Union (EU) expansion in 2004, which raises the importance of equity and equality for the recent immigrants. Previous research on ethnic health inequalities focused on established minority ethnic groups, whereas Eastern European migrants are a growing, but relatively under-researched group. We aimed to conduct a systematic scoping review of published literature on Eastern European migrants' use and experiences of UK health services. METHODS: An initial search of nine databases produced 5997 relevant publications. Removing duplicates reduced the figure to 2198. Title and abstract screening left 73 publications. Full-text screening narrowed this down further to 10 articles, with three more from these publications to leave 13 included publications. We assessed publications for quality, extracted data and undertook a narrative synthesis. RESULTS: The included publications most commonly studied sexual health and family planning services. For Eastern European migrants in the UK, the most commonly cited barriers to accessing and using healthcare were limited understanding of how the system worked and language difficulties. It was also common for migrants to return to their home country to a healthcare system they were familiar with, free from language barriers. Familial and social networks were valuable for patients with a limited command of English in the absence of suitable and available interpreting and translating services. CONCLUSIONS: To address limited understanding of the healthcare system and the English language, the NHS could produce information in all the Eastern European languages about how it operates. Adding nationality to the Electronic Patient Report Form (EPRF) may reveal the demand for interpretation and translation services. Eastern European migrants need to be encouraged to register with GPs to reduce A&E attendance for primary care conditions. Many of the issues raised will be relevant to other European countries since the long-term outcomes from Brexit are likely to influence the level of Eastern European and non-Eastern European migration across the continent, not just the UK.

Prehospital Transdermal Glyceryl Trinitrate for Ultra-Acute Intracerebral Hemorrhage: Data From the RIGHT-2 Trial.

Background and Purpose- Pilot trials suggest that glyceryl trinitrate (GTN; nitroglycerin) may improve outcome when administered early after stroke onset. Methods- We undertook a multicentre, paramedic-delivered, ambulance-based, prospective randomized, sham-controlled, blinded-end point trial in adults with presumed stroke within 4 hours of ictus. Participants received transdermal GTN (5 mg) or a sham dressing (1:1) in the ambulance and then daily for three days in hospital. The primary outcome was the 7-level modified Rankin Scale at 90 days assessed by central telephone treatment-blinded follow-up. This prespecified subgroup analysis focuses on participants with an intracerebral hemorrhage as their index event. Analyses are intention-to-treat. Results- Of 1149 participants with presumed stroke, 145 (13%; GTN, 74; sham, 71) had an intracerebral hemorrhage: time from onset to randomization median, 74 minutes (interquartile range, 45-110). By admission to hospital, blood pressure tended to be lower with GTN as compared with sham: mean, 4.4/3.5 mm Hg. The modified Rankin Scale score at 90 days was nonsignificantly higher in the GTN group: adjusted common odds ratio for poor outcome, 1.87 (95% CI, 0.98-3.57). A prespecified global analysis of 5 clinical outcomes (dependency, disability, cognition, quality of life, and mood) was worse with GTN; Mann-Whitney difference, 0.18 (95% CI, 0.01-0.35; Wei-Lachin test). GTN was associated with larger hematoma and growth, and more mass effect and midline shift on neuroimaging, and altered use of hospital resources. Death in hospital but not at day 90 was increased with GTN. There were no significant between-group differences in serious adverse events. Conclusions- Prehospital treatment with GTN worsened outcomes in patients with intracerebral hemorrhage. Since these results could relate to the play of chance, confounding, or a true effect of GTN, further randomized evidence on the use of vasodilators in ultra-acute intracerebral hemorrhage is needed. Clinical Trial Registration- URL: http://www.controlled-trials.com. Unique identifier: ISRCTN26986053.

Outcomes for Patients Who Contact the Emergency Ambulance Service and Are Not Transported to the Emergency Department: A Data Linkage Study.

Objectives: Emergency ambulance services do not transport all patients to hospital. International literature reports non-transport rates ranging from 3.7-93.7%. In 2017, 38% of the 11 million calls received by ambulance services in England were attended by ambulance but not transported to an Emergency Department (ED). A further 10% received clinical advice over the telephone. Little is known about what happens to patients following a non-transport decision. We aimed to investigate what happens to patients following an emergency ambulance telephone call that resulted in a non-transport decision, using a linked routine data-set. Methods: Six-months individual patient level data from one ambulance service in England, linked with Hospital Episode Statistics and national mortality data, were used to identify subsequent health events (ambulance re-contact, ED attendance, hospital admission, death) within 3 days (primary analysis) and 7 days (secondary analysis) of an ambulance call ending in non-transport to hospital. Non-clinical staff used a priority dispatch system e.g. Medical Priority Dispatch System to prioritize calls for ambulance dispatch. Non-transport to ED was determined by ambulance crew members at scene or clinicians at the emergency operating center when an ambulance was not dispatched (telephone advice). Results: The data linkage rate was 85% for patients who were discharged at scene (43,108/50,894). After removal of deaths associated with end of life care (N = 312), 9% (3,861/42,796) re-contacted the ambulance service, 12.6% (5,412/42,796) attended ED, 6.3% (2,694/42,796) were admitted to hospital, and 0.3% (129/42,796) died within 3 days of the call. Rates were higher for events occurring within 7 days. For example, 12% re-contacted the ambulance service, 16.1% attended ED, 9.3% were admitted to hospital, and 0.5% died. The linkage rate for telephone advice calls was low because ambulance services record less information about these patients (24% 2,514/10,634). A sensitivity analysis identified a range of subsequent event rates: 2.5-10.5% of patients were admitted to hospital and 0.06-0.24% of patient died within 3 days of the call. Conclusions: Most non-transported patients did not have subsequent health events. Deaths after non-transport are an infrequent event that could be selected for more detailed review of individual cases, to facilitate learning and improvement.

Telemonitoring in Chronic Obstructive Pulmonary Disease (CHROMED). A Randomized Clinical Trial.

RATIONALE: Early detection of chronic obstructive pulmonary disease (COPD) exacerbations using telemonitoring of physiological variables might reduce the frequency of hospitalization. OBJECTIVES: To evaluate the efficacy of home monitoring of lung mechanics by the forced oscillation technique and cardiac parameters in older patients with COPD and comorbidities. METHODS: This multicenter, randomized clinical trial recruited 312 patients with Global Initiative for Chronic Obstructive Lung Disease grades II to IV COPD (median age, 71 yr [interquartile range, 66-76 yr]; 49.6% grade II, 50.4% grades III-IV), with a history of exacerbation in the previous year and at least one nonpulmonary comorbidity. Patients were randomized to usual care (n = 158) or telemonitoring (n = 154) and followed for 9 months. All telemonitoring patients self-assessed lung mechanics daily, and in a subgroup with congestive heart failure (n = 37) cardiac parameters were also monitored. An algorithm identified deterioration, triggering a telephone contact to determine appropriate interventions. MEASUREMENTS AND MAIN RESULTS: Primary outcomes were time to first hospitalization (TTFH) and change in the EuroQoL EQ-5D utility index score. Secondary outcomes included: rate of antibiotic/corticosteroid prescription; hospitalization; the COPD Assessment Tool, Patient Health Questionnaire-9, and Minnesota Living with Heart Failure questionnaire scores; quality-adjusted life years; and healthcare costs. Telemonitoring did not affect TTFH, EQ-5D utility index score, antibiotic prescriptions, hospitalization rate, or questionnaire scores. In an exploratory analysis, telemedicine was associated with fewer repeat hospitalizations (-54%; P = 0.017). CONCLUSIONS: In older patients with COPD and comorbidities, remote monitoring of lung function by forced oscillation technique and cardiac parameters did not change TTFH and EQ-5D. Clinical trial registered with www.clinicaltrials.gov (NCT 01960907).

Proactive Assessment of Obesity Risk during Infancy (ProAsk): a qualitative study of parents' and professionals' perspectives on an mHealth intervention.

BACKGROUND: Prevention of childhood obesity is a public health priority. Interventions that establish healthy growth trajectories early in life promise lifelong benefits to health and wellbeing. Proactive Assessment of Obesity Risk during Infancy (ProAsk) is a novel mHealth intervention designed to enable health professionals to assess an infant's risk of future overweight and motivate parental behaviour change to prevent childhood overweight and obesity. The aim of this study was to explore parents' and health professionals' experiences of the overweight risk communication and behaviour change aspects of this mHealth intervention. METHODS: The study was conducted in four economically deprived localities in the UK. Parents (N = 66) were recruited to the ProAsk feasibility study when their infant was 6-8 weeks old. Twenty two health visitors (HVs) used a hand-held tablet device to deliver ProAsk to parents when their infants were 3 months old. Parents (N = 12) and HVs (N = 15) were interviewed when infants in the study were 6 months old. Interview data were transcribed and analysed thematically using an inductive, interpretative approach. RESULTS: Four key themes were identified across both parent and health visitor data: Engaging and empowering with digital technology; Unfamiliar technology presents challenges and opportunity; Trust in the risk score; Resistance to targeting. Most participants found the interactivity and visual presentation of information on ProAsk engaging. Health visitors who were unfamiliar with mobile technology drew support from parents who were more confident using tablet devices. There was evidence of resistance to targeting infants at greatest risk of future overweight and obesity, and both parents and health visitors drew on a number of reasons why a higher than average overweight risk score might not apply to a particular infant. CONCLUSIONS: An mHealth intervention actively engaged parents, enabling them to take ownership of the process of seeking strategies to reduce infant risk of overweight. However, cognitive and motivational biases that prevent effective overweight risk communication are barriers to targeting an intervention at those infants most at risk. TRIAL REGISTRATION: NCT02314494 . Date registered 11th December 2014.

The Sleep Condition Indicator: reference values derived from a sample of 200 000 adults.

The Sleep Condition Indicator (SCI) is an eight-item rating scale that was developed to screen for insomnia disorder based on DSM-5 criteria. It has been shown previously to have good psychometric properties among several language translations. We developed age- and sex-referenced values for the SCI to assist the evaluation of insomnia in everyday clinical practice. A random sample of 200 000 individuals (58% women, mean age: 31 ± 13 years) was selected from those who had completed the SCI via several internet platforms. Descriptive and inferential methods were applied to generate reference data and indices of reliable change for the SCI for men and women across the age deciles 16-25, 26-35, 36-45, 46-55, 56-65 and 66-75 years. The mean SCI score for the full sample was 14.97 ± 5.93. Overall, women scored worse than men (14.29 ± 5.83 versus 15.90 ± 5.94; mean difference: -1.60, η2  = 0.018, Cohen's d = 0.272) and those of older age scored worse than those younger (-0.057 points per year, 95% confidence interval (CI): -0.059 to -0.055) relative to age 16-25 years. The Reliable Change Index was established at seven scale points. In conclusion, the SCI is a useful instrument for clinicians and researchers that can help them to screen for insomnia, compare completers to individuals of similar age and sex and establish whether a reliable change was achieved following treatment.

A coproduced patient and public event: An approach to developing and prioritizing ambulance performance measures.

BACKGROUND: Patient and public involvement (PPI) is recognized as an important component of high-quality health services research. PPI is integral to the Pre-hospital Outcomes for Evidence Based Evaluation (PhOEBE) programme. The PPI event described in detail in this article focusses on the process of involving patients and public representatives in identifying, prioritizing and refining a set of outcome measures that can be used to support ambulance service performance measurement. OBJECTIVE: To obtain public feedback on little known, complex aspects of ambulance service performance measurement. DESIGN: The event was codesigned and coproduced with the PhOEBE PPI reference group and PhOEBE research team. The event consisted of brief researcher-led presentations, group discussions facilitated by the PPI reference group members and electronic voting. SETTING AND PARTICIPANTS: Data were collected from eighteen patient and public representatives who attended an event venue in Yorkshire. RESULTS: The results of the PPI event showed that this interactive format and mode of delivery was an effective method to obtain public feedback and produced a clear indication of which ambulance performance measures were most highly favoured by event participants. DISCUSSION AND CONCLUSIONS: The event highlighted valuable contributions the PPI reference group made to the design process, supporting participant recruitment and facilitation of group discussions. In addition, the positive team working experience of the event proved a catalyst for further improvements in PPI within the PhOEBE project.

Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review.

BACKGROUND: We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting. METHODS: A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data. The data extraction concentrated on ethical considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. RESULTS: In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Type of consent differed depending on the condition or intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from consent appeared to be most commonly used. A wide range of terms were used to describe consent. CONCLUSIONS: Consent was the main ethical consideration in published ambulance based research. A range of consent models were used ranging from informed consent to exception from consent (waiver of consent). Many studies cited international guidelines as informing their choice of consent model but diverse and sometimes confused terms were used to describe these models. This suggests that standardisation of consent models and the terminology used to describe them is warranted.

Multiple triangulation and collaborative research using qualitative methods to explore decision making in pre-hospital emergency care.

BACKGROUND: Paramedics make important and increasingly complex decisions at scene about patient care. Patient safety implications of influences on decision making in the pre-hospital setting were previously under-researched. Cutting edge perspectives advocate exploring the whole system rather than individual influences on patient safety. Ethnography (the study of people and cultures) has been acknowledged as a suitable method for identifying health care issues as they occur within the natural context. In this paper we compare multiple methods used in a multi-site, qualitative study that aimed to identify system influences on decision making. METHODS: The study was conducted in three NHS Ambulance Trusts in England and involved researchers from each Trust working alongside academic researchers. Exploratory interviews with key informants e.g. managers (n = 16) and document review provided contextual information. Between October 2012 and July 2013 researchers observed 34 paramedic shifts and ten paramedics provided additional accounts via audio-recorded 'digital diaries' (155 events). Three staff focus groups (total n = 21) and three service user focus groups (total n = 23) explored a range of experiences and perceptions. Data collection and analysis was carried out by academic and ambulance service researchers as well as service users. Workshops were held at each site to elicit feedback on the findings and facilitate prioritisation of issues identified. RESULTS: The use of a multi-method qualitative approach allowed cross-validation of important issues for ambulance service staff and service users. A key factor in successful implementation of the study was establishing good working relationships with academic and ambulance service teams. Enrolling at least one research lead at each site facilitated the recruitment process as well as study progress. Active involvement with the study allowed ambulance service researchers and service users to gain a better understanding of the research process. Feedback workshops allowed stakeholders to discuss and prioritise findings as well as identify new research areas. CONCLUSION: Combining multiple qualitative methods with a collaborative research approach can facilitate exploration of system influences on patient safety in under-researched settings. The paper highlights empirical issues, strengths and limitations for this approach. Feedback workshops were effective for verifying findings and prioritising areas for future intervention and research.

Perceptions on use of home telemonitoring in patients with long term conditions - concordance with the Health Information Technology Acceptance Model: a qualitative collective case study.

BACKGROUND: Health information technology (HIT) may be used to improve care for increasing numbers of older people with long term conditions (LTCs) who make high demands on health and social care services. Despite its potential benefits for reducing disease exacerbations and hospitalisations, HIT home monitoring is not always accepted by patients. Using the Health Information Technology Acceptance Model (HITAM) this qualitative study examined the usefulness of the model for understanding acceptance of HIT in older people (≥60 years) participating in a RCT for older people with Chronic Obstructive Pulmonary Disease (COPD) and associated heart diseases (CHROMED). METHODS: An instrumental, collective case study design was used with qualitative interviews of patients in the intervention arm of CHROMED. These were conducted at two time points, one shortly after installation of equipment and again at the end of (or withdrawal from) the study. We used Framework Analysis to examine how well the HITAM accounted for the data. RESULTS: Participants included 21 patients aged between 60-99 years and their partners or relatives where applicable. Additional concepts for the HITAM for older people included: concerns regarding health professional access and attachment; heightened illness anxiety and desire to avoid continuation of the 'sick-role'. In the technology zone, HIT self-efficacy was associated with good organisational processes and informal support; while ease of use was connected to equipment design being suitable for older people. HIT perceived usefulness was related to establishing trends in health status, detecting early signs of infection and potential to self-manage. Due to limited feedback to users opportunities to self-manage were reduced. CONCLUSIONS: HITAM helped understand the likelihood that older people with LTCs would use HIT, but did not explain how this might result in improved self-management. In order to increase HIT acceptance among older people, equipment design and organisational factors need to be considered. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01960907 October 9 2013 (retrospectively registered) Clinical tRials fOr elderly patients with MultiplE Disease (CHROMED). Start date October 2012, end date March 2016. Date of enrolment of the first participant was February 2013.

Comparing importance and performance from a patient perspective in English general practice: a cross-sectional survey.

BACKGROUND: Patient experience and satisfaction are important indicators of quality in health care. Little is known about where to prioritize efforts to improve patient satisfaction. OBJECTIVES: To investigate patient satisfaction with primary care, as part of the Quality and Costs of Primary Care in Europe study in England, identifying areas where improvements could be made from patients' perspectives. METHODS: We conducted a questionnaire survey of general practice patients in three English regions. Patient Values questionnaires assessed what patients thought was important, and Patient Experience questionnaires rated performance of primary care. Fifteen attributes of care were compared using Importance Performance Analysis, a method that simultaneously represents data on importance and performance of a service, enabling identification of its strengths and weaknesses. RESULTS: Patients rated both 'relational' and 'functional' aspects of care as important. Satisfaction with general practice could be improved by concentrating on specific aspects of access (ensuring that patients know how to access out-of-hours services and find it easy to get an appointment), and one aspect of empowerment (after their visit, patients feel able to cope better with their health problem/illness). However, for other attributes (e.g. proximity of the practice to a patient's house or, a short waiting time when contacting the practice), investing additional resources is not likely to increase patient satisfaction. CONCLUSION: Attributes needing most improvement concerned access to primary care and patient empowerment. More research is needed to identify how to improve access without generating unnecessary additional demand or compromising continuity of care.

Views of paramedics on their role in an out-of-hospital ambulance-based trial in ultra-acute stroke: qualitative data from the Rapid Intervention With Glyceryl Trinitrate in Hypertensive Stroke Trial (RIGHT).

STUDY OBJECTIVE: Optimal practices for recruiting, consenting, and randomizing patients, and delivering treatment in out-of-hospital ultra-acute stroke trials, remain unclear. We aim to identify key barriers and facilitators relevant to the design and conduct of ambulance-based stroke trials and to formulate preliminary recommendations for the design of future trials. METHODS: Using semistructured interviews, we investigated the experiences and challenges faced by paramedics who took part in a randomized controlled trial in suspected ultra-acute stroke, the Rapid Intervention With Glyceryl Trinitrate in Hypertensive Stroke Trial (RIGHT), in which recruitment, consent, randomization, assessment, and treatment were delivered by paramedics before hospitalization. RESULTS: We purposively selected a diversity sample of 14 of the 78 paramedics who participated in RIGHT. We identified 13 themes (7 facilitators and 6 barriers to out-of-hospital stroke research). A simple stroke diagnostic tool, use of proxy consent on behalf of patients, and straightforward trial processes were identified as the main facilitators. Recruitment became easier with each new randomization attempt. Key barriers reported were informed consent in the emergency setting, lack of institutional support for research, learning curve and rarity (each paramedic treats only a few eligible patients), and difficulty in attending training sessions. Interviewed paramedics were motivated to participate in research. CONCLUSION: Ultra-acute stroke research in the out-of-hospital environment is feasible, but important barriers need to be addressed. Proxy consent by paramedics addresses some of the difficulties with the consent process in the out-of-hospital setting.