An evaluation of a public partnership project between academic institutions and young people with Black African, Asian and Caribbean heritage.

BACKGROUND: This project (named Reinvent) aimed to promote Public Involvement (PI) in health research. Academics worked with a community group, the Eloquent Praise & Empowerment Dance Company, to develop a community partnership with young people from Black African, Asian and Caribbean heritage communities. The goal of this paper is to evaluate the Reinvent project for key learnings on how to engage and build partnerships with young people from Black African, Asian and Caribbean heritage communities. METHODS: Reinvent developed a steering group which consisted of five young people, one academic, a Race Equality Ambassador and the Director of Eloquent. The steering group co-produced an agenda for two workshops and the evaluation tools used. The content of the workshops included drama exercises, discussions on physical and mental health, nutrition and school-life, short introductions to the concepts of research and PI, and group work to critique and improve a video currently used to promote PI in health research to young people. The evaluation tools included using the 'Cube' evaluation framework, video-blogging and collecting anonymous feedback. Findings The responses to the 'Cube' evaluation framework were positive across all four domains (agenda, voice, contribute change) in both workshops. A few of the young people described having a better understanding of the meaning and practice of PI in a video-blog. The anonymous feedback suggested that the workshops had increased young people's confidence in sharing their thoughts and opinions about health and PI. CONCLUSION: Reinvent has shown that academic institutions and young people from an under-served community can partner to co-design workshops and apply evaluation tools. Working with young people in an environment in which they were comfortable, and by researchers joining in with the activities that the young people enjoyed (such as dance), enabled more informal and open conversations to develop. More work is needed to build upon this project so that young people can feel confident and supported to get involved in PI activities relating to research.

The effects of care bundles on patient outcomes: a systematic review and meta-analysis.

BACKGROUND: Care bundles are a set of three to five evidence-informed practices performed collectively and reliably to improve the quality of care. Care bundles are used widely across healthcare settings with the aim of preventing and managing different health conditions. This is the first systematic review designed to determine the effects of care bundles on patient outcomes and the behaviour of healthcare workers in relation to fidelity with care bundles. METHODS: This systematic review is reported in line with the PRISMA statement for reporting systematic reviews and meta-analyses. A total of 5796 abstracts were retrieved through a systematic search for articles published between January 1, 2001, to February 4, 2017, in the Cochrane Central Register for Controlled Trials, MEDLINE, EMBASE, British Nursing Index, CINAHL, PsychInfo, British Library, Conference Proceeding Citation Index, OpenGrey trials (including cluster-randomised trials) and non-randomised studies (comprising controlled before-after studies, interrupted time series, cohort studies) of care bundles for any health condition and any healthcare settings were considered. Following the removal of duplicated studies, two reviewers independently screen 3134 records. Three authors performed data extraction independently. We compared the care bundles with usual care to evaluate the effects of care bundles on the risk of negative patient outcomes. Random-effect models were used to further explore the effects of subgroups. RESULTS: In total, 37 studies (6 randomised trials, 31 controlled before-after studies) were eligible for inclusion. The effect of care bundles on patient outcomes is uncertain. For randomised trial data, the pooled relative risk of negative effects between care bundle and control groups was 0.97 [95% CI 0.71 to 1.34; 2049 participants]. The relative risk of negative patient outcomes from controlled before-after studies favoured the care bundle treated groups (0.66 [95% CI 0.59 to 0.75; 119,178 participants]). However, using GRADE, we assessed the certainty of all of the evidence to be very low (downgraded for risk of bias, inconsistency, indirectness). CONCLUSIONS: Very low quality evidence from controlled before-after studies suggests that care bundles may reduce the risk of negative outcomes when compared with usual care. By contrast, the better quality evidence from six randomised trials is more uncertain. TRIAL REGISTRATION: PROSPERO, CRD42016033175.

Bypassing nearest hospital for more distant neuroscience care in head-injured adults with suspected traumatic brain injury: findings of the head injury transportation straight to neurosurgery (HITS-NS) pilot cluster randomised trial.

OBJECTIVE: Reconfiguration of trauma services, with direct transport of patients with traumatic brain injury (TBI) to specialist neuroscience centres (SNCs)-bypassing non-specialist acute hospitals (NSAHs), could improve outcomes. However, delays in stabilisation of airway, breathing and circulation (ABC) may worsen outcomes when compared with selective secondary transfer from nearest NSAH to SNC. We conducted a pilot cluster randomised controlled trial to determine the feasibility and plausibility of bypassing suspected patients with TBI -directly into SNCs-producing a measurable effect. SETTING: Two English Ambulance Services. PARTICIPANTS: 74 clusters (ambulance stations) were randomised within pairs after matching for important characteristics. Clusters enrolled head-injured adults-injured nearest to an NSAH-with internationally accepted TBI risk factors and stable ABC. We excluded participants attended by Helicopter Emergency Medical Services or who were injured more than 1 hour by road from nearest SNC. INTERVENTIONS: Intervention cluster participants were transported directly to an SNC bypassing nearest NSAH; control cluster participants were transported to nearest NSAH with selective secondary transfer to SNC. OUTCOMES: Trial recruitment rate (target n=700 per annum) and percentage with TBI on CT scan (target 80%) were the primary feasibility outcomes. 30-day mortality, 6-month Extended Glasgow Outcome Scale and quality of life were secondary outcomes. RESULTS: 56 ambulance station clusters recruited 293 patients in 12 months. The trial arms were similar in terms of age, conscious level and injury severity. Less than 25% of recruited patients had TBI on CT (n=70) with 7% (n=20) requiring neurosurgery. Complete case analysis showed similar 30-day mortality in the two trial arms (control=8.8 (2.7-14.0)% vs intervention=9.4(2.3-14.0)%). CONCLUSION: Bypassing patients with suspected TBI to SNCs gives an overtriage (false positive) ratio of 13:1 for neurosurgical intervention and 4:1 for TBI. A measurable effect from a full trial of early neuroscience care following bypass is therefore unlikely. TRIAL REGISTRATION NUMBER: ISRCTN68087745.

The Head Injury Transportation Straight to Neurosurgery (HITS-NS) randomised trial: a feasibility study.

BACKGROUND: Reconfiguration of trauma services, with direct transport of traumatic brain injury (TBI) patients to neuroscience centres (NCs), bypassing non-specialist acute hospitals (NSAHs), could potentially improve outcomes. However, delays in stabilisation of airway, breathing and circulation (ABC) and the difficulties in reliably identifying TBI at scene may make this practice deleterious compared with selective secondary transfer from nearest NSAH to NC. National Institute for Health and Care Excellence guidance and systematic reviews suggested equipoise and poor-quality evidence - with regard to 'early neurosurgery' in this cohort - which we sought to address. METHODS: Pilot cluster randomised controlled trial of bypass to NC conducted in two ambulance services with the ambulance station (n = 74) as unit of cluster [Lancashire/Cumbria in the North West Ambulance Service (NWAS) and the North East Ambulance Service (NEAS)]. Adult patients with signs of isolated TBI [Glasgow Coma Scale (GCS) score of < 13 in NWAS, GCS score of < 14 in NEAS] and stable ABC, injured nearest to a NSAH were transported either to that hospital (control clusters) or bypassed to the nearest NC (intervention clusters). PRIMARY OUTCOMES: recruitment rate, protocol compliance, selection bias as a result of non-compliance, accuracy of paramedic TBI identification (overtriage of study inclusion criteria) and pathway acceptability to patients, families and staff. 'Open-label' secondary outcomes: 30-day mortality, 6-month Extended Glasgow Outcome Scale (GOSE) and European Quality of Life-5 Dimensions. RESULTS: Overall, 56 clusters recruited 293 (169 intervention, 124 control) patients in 12 months, demonstrating cluster randomised pre-hospital trials as viable for heath service evaluations. Overall compliance was 62%, but 90% was achieved in the control arm and when face-to-face paramedic training was possible. Non-compliance appeared to be driven by proximity of the nearest hospital and perceptions of injury severity and so occurred more frequently in the intervention arm, in which the perceived time to the NC was greater and severity of injury was lower. Fewer than 25% of recruited patients had TBI on computed tomography scan (n = 70), with 7% (n = 20) requiring neurosurgery (craniotomy, craniectomy or intracranial pressure monitoring) but a further 18 requiring admission to an intensive care unit. An intention-to-treat analysis revealed the two trial arms to be equivalent in terms of age, GCS and severity of injury. No significant 30-day mortality differences were found (8.8% vs. 9.1/%; p > 0.05) in the 273 (159/113) patients with data available. There were no apparent differences in staff and patient preferences for either pathway, with satisfaction high with both. Very low responses to invitations to consent for follow-up in the large number of mild head injury-enrolled patients meant that only 20% of patients had 6-month outcomes. The trial-based economic evaluation could not focus on early neurosurgery because of these low numbers but instead investigated the comparative cost-effectiveness of bypass compared with selective secondary transfer for eligible patients at the scene of injury. CONCLUSIONS: Current NHS England practice of bypassing patients with suspected TBI to neuroscience centres gives overtriage ratios of 13 : 1 for neurosurgery and 4 : 1 for TBI. This important finding makes studying the impact of bypass to facilitate early neurosurgery not plausible using this study design. Future research should explore an efficient comparative effectiveness design for evaluating 'early neurosurgery through bypass' and address the challenge of reliable TBI diagnosis at the scene of injury. TRIAL REGISTRATION: Current Controlled Trials ISRCTN68087745. 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. 20, No. 1. See the NIHR Journals Library website for further project information.

The diagnostic accuracy of the HITSNS prehospital triage rule for identifying patients with significant traumatic brain injury: a cohort study.

Diversion of suspected traumatic brain injury (TBI) patients to trauma centres may improve outcomes by expediting access to specialist neurosurgical care. This study aimed to determine the accuracy of the Head Injury Straight to Neurosurgery (HITSNS) triage rule for identifying patients with significant TBI. A diagnostic cohort study was performed using data from the HITSNS trial, the Trauma Audit and Research Network registry and the North East Ambulance service database. Sensitivity and specificity of the HITSNS triage rule were calculated against a reference standard of significant TBI, defined by a cranial Abbreviated Injury Scale score of at least 3 or by the performance of a neurosurgical procedure. A total of 3628 patients were included in the complete case analyses. The HITSNS triage tool demonstrated a sensitivity of 28.3% (95% confidence interval 21.8-35.4) and a specificity of 94.4% (95% confidence interval 93.6-95.2). The low sensitivity of the HITSNS triage rule suggests that a considerable proportion of patients with significant TBI may not be triaged directly to trauma centres, and further research is needed to improve the accuracy of bypass protocols.

The challenges of conducting prehospital research: successes and lessons learnt from the Head Injury Transportation Straight to Neurosurgery (HITS-NS) trial.

Head Injury Transportation Straight to Neurosurgery was a cluster randomised trial studying suspected severe head injury treatment pathways conducted in the North East Ambulance Service NHS Foundation Trust and North West Ambulance Service NHS Trust between January 2012 and March 2013. This was the world's first large scale trial of any trauma bypass and was conducted as a feasibility study. This short report will describe some of the lessons learnt during this ground breaking and complex trial.

"I assumed that one was a placebo": exploring the consent process in a sham controlled acupressure trial.

OBJECTIVES: In clinical trials where participants are likely to be able to distinguish between true and sham interventions, informing participants that they may receive a sham intervention increases the likelihood of participants 'breaking the blind' and invalidating trial findings. The present study explored participants' perceptions of the consent process in a sham controlled acupressure trial which did not explicitly indicate participants may receive a sham intervention. DESIGN: Nested qualitative study within a randomised sham controlled trial of acupressure wristbands for chemotherapy-related nausea. Convenience sample of 26 patients participated in semi-structured interviews. Interviews were audio-recorded and transcribed verbatim. Transcripts analysed thematically using framework analysis. SETTING: Study conducted within three geographical sites in the UK: Manchester, Liverpool, and Plymouth. RESULTS: All participants indicated that they believed they were fully informed when providing written consent to participate in the trial. Participants' perceived it was acceptable to employ a sham intervention within the trial of acupressure wristbands without informing potential participants that they may receive a sham treatment. Despite the fact that participants were not informed that one of the treatment arms was a sham intervention the majority indicated they assumed one of the treatment arms would be placebo. CONCLUSIONS: Many trials of acupuncture and acupressure do not inform participants they may receive a sham intervention. The current study indicates patients' perceive this approach to the consent process as acceptable. However, the fact participants assume one treatment may be placebo threatens the methodological basis for utilising this approach to the consent process.

The effectiveness of acupressure for the control and management of chemotherapy-related acute and delayed nausea: a randomized controlled trial.

CONTEXT: Both positive and negative results have been reported in the literature from the use of acupressure at the P6 point, providing evidence of highly suggestive but not conclusive results. OBJECTIVES: To clarify whether acupressure is effective in the management of chemotherapy-related nausea and vomiting. METHODS: A randomized, three-group, sham-controlled trial was designed. Patients with cancer receiving chemotherapy were randomized to receive standardized antiemetics and acupressure wristbands, sham acupressure wristbands, or antiemetics alone. Primary outcome assessment (nausea) was carried out daily for seven days per chemotherapy cycle over four cycles. Secondary outcomes included vomiting, psychological distress, and quality of life. RESULTS: Five hundred patients were randomized. Primary outcome analysis (nausea in Cycle 1) revealed no statistically significant differences between the three groups, although nausea levels in the proportion of patients using wristbands (both real and sham) were somewhat lower than those in the proportion of patients using antiemetics-only group. Adjusting for gender, age, and emetic risk of chemotherapy, the odds ratio of lower nausea experience was 1.18 and 1.42 for the acupressure and sham acupressure groups, respectively. A gender interaction effect was evident (P = 0.002). No significant differences were detected in relation to vomiting, anxiety, and quality-of-life measures. CONCLUSION: No clear recommendations can be made about the use of acupressure wristbands in the management of chemotherapy-related nausea and vomiting as results did not reach statistical significance. However, the study provided evidence of encouraging signals in relation to improved nausea experience and warrants further consideration in both practice and further clinical trials. TRIAL REGISTRATION: This trial is registered with the ISRCT register, number ISRCTN87604299.

"Until the trial is complete you can't really say whether it helped you or not, can you?": exploring cancer patients' perceptions of taking part in a trial of acupressure wristbands.

BACKGROUND: Nested qualitative studies within clinical trials provide data on patients' experiences of receiving trial interventions and can inform and improve trial designs. The present study explored patients' experiences of participating in a randomised controlled trial of acupressure wristbands for chemotherapy related nausea. METHODS: A randomised three-group sham-controlled trial was carried out to evaluate the effectiveness of acupressure wristbands in the management of chemotherapy-related nausea. A convenience sample of 26 patients volunteered to participate in a qualitative study to explore their experiences of using acupressure wristbands, and taking part in the clinical trial. Participants were recruited from each of the three UK geographical sites from which the trial was conducted: Manchester, Liverpool and Plymouth. In-depth semi-structured interviews were conducted with the participants in their own homes or other location convenient for participating patients. Interviews were audio-taped, transcribed verbatim and analysed using Framework methodology. RESULTS: The main motivational factors influencing participants to take part in the trial were a desire to 'give something back' and limit their own experience of nausea. Participants were largely satisfied with the organisation and running of the acupressure wristband trial. Many participants experienced positive outcomes as a result of taking part in the trial. Lapses in memory, or poor health as a result of their chemotherapy treatment, led to some participants failing to complete trial paperwork on designated days. Two sham wristband participants reported wearing the bands inappropriately resulting in pressure being applied to the acupoint. Almost all of the participants interviewed had only experienced mild nausea or vomiting during the trial. Participants were pragmatic on the extent to which the wristbands were responsible for this lack of nausea and vomiting during the trial. However, many participants, including some patients receiving sham acupressure, believed the wristbands to have had a positive impact on their nausea and vomiting; there was a perception that the wristbands were, at least in part, responsible for the lack of nausea and vomiting they had experienced. CONCLUSIONS: Participants perceive acupressure wristbands as reducing the level of nausea and vomiting experienced during chemotherapy treatment. Reports that some participants wore wristbands inappropriately, and/or delayed completion of trial paperwork could represent confounding variables and have implications for the trial results, and the design of clinical trials within the field of cancer.

Improving quality of life for older people in the community: findings from a local Partnerships for Older People Project innovation and evaluation.

BACKGROUND: Partnerships for Older People Projects (POPP) was a national initiative in England aimed at improving health, well-being and quality of life (QoL) for older people by developing local services. This development paper reports the key findings of a local evaluation in relation to quality of life, well-being and health-related QoL to provide practical understanding at the local level about what this means in relation to the schemes delivered. OBJECTIVES: To identify the impact of POPP schemes received by older people in Wigan on their QoL and well-being; and establish their feedback on services using local indicators. METHODS: Convenience samples of older people receiving services from three selected 'community facing low level' schemes were recruited over a two-month period. They completed a semi-structured questionnaire at baseline (T1) and at follow-up 6 weeks later (T2). Information was collected on health status and health-related QoL using the EQ-5D, biographical information, overall QoL and well-being as part of the national evaluation and a local indicator, feedback on services. RESULTS: Response rates were 70% (T1 45/64, mean age 72 years) and 43% at T2 (25/58, mean age 55 years). Following receipt of these schemes improvements were found for self care, anxiety and depression, health status and QoL although these differences were not statistically significant due to the small sample size and loss to follow-up. Feedback on local service use related to schemes 'being fit for purpose' and 'aspects of service delivery'. CONCLUSION: This local evaluation illustrates a pragmatic approach to service development and delivery of preventative services, with potential to benefit health and well-being of older people and support their continued living independently in the community. It provides detail and better understanding of what this means locally to people in context of national findings.

Service developments for managing people with long-term conditions using case management approaches, an example from the UK.

INTRODUCTION: This research has considered current developments in the provision of services for people with long-term conditions within the NHS of England. Community Matrons are being employed and by adopting a case management approach they are aiming to improve patient care and reduce their demands for acute hospital care. DESCRIPTION: Qualitative research was undertaken to explore experiences of community matrons and service leads on the development, implementation and provision of services for people with long-term conditions. CONCLUSIONS: This research provides evidence of what is being done to meet the challenge of long-term conditions and provides lessons for similar challenges and service development for different areas of care and in other countries. Continual system and role change has had effects on service delivery and on the whole care. These effects relate to; defining the role of community matron and structure of service, training staff, identifying patients, providing infrastructure, demonstrating benefits, identifying gaps in services, ability to reduce avoidable admissions and identifying the advantages and difficulties of the role. DISCUSSION: All of these aspects should be used to inform future development.

An evaluation of a multidisciplinary team for intermediate care at home.

BACKGROUND: The implementation of the National Health Service Plan for the UK will see an expansion of services for intermediate care. Such services are usually targeted at older people and aim to: prevent 'avoidable' admissions to acute inpatient care; facilitate the timely discharge of patients from acute inpatient care; promote patient rehabilitation. A range of services might fall under the banner of intermediate care. They are usually delivered in patients' homes or in non-acute institutions. This paper describes an evaluation of a multidisciplinary Rapid Response Team (RRT). This service aimed to provide a home based alternative to care previously provided in an acute hospital bed which was acceptable to patients and carers and which maintained clinical care standards. The service was provided for the population of Hereford, a rural town in the middle of England. METHODS: A mixed-method descriptive design using quantitative and qualitative techniques was used to monitor: the characteristics of service users, the types and amounts of care received, any 'adverse' events arising from that care, and the acceptability of the service to patients and carers. A collaborative approach involving key stakeholders allowed appropriate data to be gathered from patient case notes, RRT staff, local health and social care providers, and patients and their carers. A suite of self-completed questionnaires was, therefore, designed to capture study data on patients and activities of care, and workshops and semi-structured interview schedules used to obtain feedback from users and stakeholders. RESULTS: Service users (231) were elderly (mean age 75.9), from three main diagnostic categories (respiratory conditions 19.0%, heart/stroke 16.2%, falls 13.4%), with the majority (57.0%) having both medical and social care needs. All patients received care at home (mean duration 5.6 days) with only 5.7% of patients having to be re-admitted to acute care. Overall, patients and carers had positive attitudes to the new service but some expressed concerns about their ability to influence the choice of care option (24.1% and 25.0% of patients and carers, respectively), whilst 22.7% of carers were concerned about the quality of information about care. CONCLUSIONS: Both the nature of schemes for intermediate care, and the policy context in which they are introduced, mean that pragmatic methodologies are often required to evaluate their impacts. Unfortunately, this need for pragmatism can then mean that it is difficult to reach definitive conclusions about the merits of schemes. However, the findings of this evaluation suggest that the Rapid Response Team provided an 'acceptable' alternative to an extended period of care in an acute setting. Such schemes may have relevance beyond the NHS of the UK as a means of providing a more appropriate and cost efficient match between patients' needs for care, the types of care provided, and the place in which care is provided.