Healthcare professional views about a prehospital redirection pathway for stroke thrombectomy: a multiphase deductive qualitative study.

BACKGROUND: Mechanical thrombectomy for stroke is highly effective but time-critical. Delays are common because many patients require transfer between local hospitals and regional centres. A two-stage prehospital redirection pathway consisting of a simple ambulance screen followed by regional centre assessment to select patients for direct admission could optimise access. However, implementation might be challenged by the limited number of thrombectomy providers, a lack of prehospital diagnostic tests for selecting patients and whether finite resources can accommodate longer ambulance journeys plus greater central admissions. We undertook a three-phase, multiregional, qualitative study to obtain health professional views on the acceptability and feasibility of a new pathway. METHODS: Online focus groups/semistructured interviews were undertaken designed to capture important contextual influences. We purposively sampled NHS staff in four regions of England. Anonymised interview transcripts underwent deductive thematic analysis guided by the NASSS (Non-adoption, Abandonment and Challenges to Scale-up, Spread and Sustainability, Implementation) Implementation Science framework. RESULTS: Twenty-eight staff participated in 4 focus groups, 2 group interviews and 18 individual interviews across 4 Ambulance Trusts, 5 Hospital Trusts and 3 Integrated Stroke Delivery Networks (ISDNs). Five deductive themes were identified: (1) (suspected) stroke as a condition, (2) the pathway change, (3) the value participants placed on the proposed pathway, (4) the possible impact on NHS organisations/adopter systems and (5) the wider healthcare context. Participants perceived suspected stroke as a complex scenario. Most viewed the proposed new thrombectomy pathway as beneficial but potentially challenging to implement. Organisational concerns included staff shortages, increased workflow and bed capacity. Participants also reported wider socioeconomic issues impacting on their services contributing to concerns around the future implementation. CONCLUSIONS: Positive views from health professionals were expressed about the concept of a proposed pathway while raising key content and implementation challenges and useful 'real-world' issues for consideration.

Assessing deprescribing tools for implementation in care homes: A qualitative study of the views of care home staff.

BACKGROUND: Care home residents often experience polypharmacy (defined as taking five or more regular medicines). Therefore, we need to ensure that residents only take the medications that are appropriate or provide value (also known as medicines optimisation). To achieve this, deprescribing, or the reduction or stopping of prescription medicines that may no longer be providing benefit, can help manage polypharmacy and improve outcomes. Various tools, guides, and approaches have been developed to help support health professionals to deprescribe in regular practice. Little evaluation of these tools has been conducted and no work has been done in the care home setting. OBJECTIVE: This qualitative study aimed to assess distinct types of deprescribing tools for acceptability, feasibility, and suitability for the care home setting. METHODS: Cognitive (think-aloud) interviews with care home staff in England were conducted (from December 2021 to June 2022) to assess five different deprescribing tools. The tools included a general deprescribing guidance, a generic (non-drug specific) deprescribing framework, a drug-specific deprescribing guideline/guide, a tool for identifying potentially inappropriate medications, and an electronic clinical decision support tool. Participants were recruited via their participation in another deprescribing study. The Consolidated Framework for Implementation Research informed the data collection and analysis. RESULTS: Eight care home staff from 7 different care homes were interviewed. The five deprescribing tools were reviewed and assessed as not acceptable, feasible, or suitable for the care home setting. All would require significant modifications for use in the care home setting (e.g., language, design, and its function or use with different stakeholders). CONCLUSIONS: As none of the tools were deemed acceptable, feasible, and suitable, future work is warranted to develop and tailor deprescribing tools for the care home setting, considering its specific context and users. Deprescribing implemented safely and successfully in care homes can benefit residents and the wider health economy.

Exploring the rise and diversity of health and societal issues that use a public health approach: A scoping review and narrative synthesis.

There is an increase in calls across diverse issues for a "public health approach" however, it is not clear whether there is any shared understanding in approach in its conceptualisation or implementation. Our aims were to (1) identify and categorise the issues which discuss a public health approach within published literature since 2010, (2) chart the descriptions and applications of public health approaches across and within four purposively sampled categories of issues, and (3) capture any evaluations conducted. A scoping review of published literature was undertaken; Seven leading databases were searched: AMED, APA PsycInfo, ASSIA, CINAHL complete, Cochrane Library (Review), Embase, and MEDLINE for articles published between 2010 and 2022 which have applied, described or called for a "public health approach" to address any issue. 3,573 studies were identified through our initial searches, of these 1,635 articles were recognised for possible inclusion from analysis of titles and abstract. The final number of included studies was 1,314. We identified 28 categories, 26 of which were societal issues, where a public health approach is being advocated. We purposively selected four of these categories; adverse childhood experiences; end of life care; gambling addiction and violence reduction/ knife crime for further analysis of the approach including how it was conceptualised and operationalised; less than 13% of the studies described the implementation of a public health approach and there was considerable heterogeneity across and within categories as to how this was done. Since 2010 there have been increasing calls for a public health approach to be taken to address health and societal challenges. However, the operationalisation of a public health approach varied extensively and there were few evaluations of the approach. This has implications for policy makers and those involved in commissioning related approaches in the future as the evidence-base is limited.

Determinants of implementing deprescribing for older adults in English care homes: a qualitative interview study.

OBJECTIVES: To explore the factors that may help or hinder deprescribing practice for older people within care homes. DESIGN: Qualitative semistructured interviews using framework analysis informed by the Consolidated Framework for Implementation Research (CFIR). SETTING: Participants were recruited from two care home provider organisations (a smaller independently owned organisation and a large organisation) in England. PARTICIPANTS: A sample of 23 care home staff, 8 residents, 4 family members and 1 general practitioner were associated with 15 care homes. RESULTS: Participants discussed their experiences and perceptions of implementing deprescribing within care homes. Major themes of (1) deprescribing as a complex process and (2) internal and external contextual factors influencing deprescribing practice (such as beliefs, abilities and relationships) were interrelated and spanned several CFIR constructs and domains. The quality of local relationships with and support from healthcare professionals were considered more crucial factors than the type of care home management structure. CONCLUSIONS: Several influencing social and contextual factors need to be considered for implementing deprescribing for older adults in care homes. Additional training, tools, support and opportunities need to be made available to care home staff, so they can feel confident and able to question or raise concerns about medicines with prescribers. Further work is warranted to design and adopt a deprescribing approach which addresses these determinants to ensure successful implementation.

Prevalence of and Risk Factors for Post-traumatic Headache in Civilian Patients After Mild Traumatic Brain Injury: A TRACK-TBI Study.

OBJECTIVE: To ascertain the prevalence of and risk factors for post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI). PATIENTS AND METHODS: A prospective, longitudinal, multicenter cohort study of patients with mTBI and orthopedic trauma controls who were enrolled from February 26, 2014, to August 8, 2018. The baseline assessment was conducted as soon as possible following evaluation at the emergency department. Follow-ups were scheduled at 2 weeks, 3 months, 6 months, and 12 months postinjury. Eligible patients with mTBI included those 18 years of age or older who presented to the emergency department within 24 hours of head injury warranting evaluation by noncontrast head computed tomography scan. Acute PTH was considered present when a patient reported a headache score of greater than or equal to 2 on the Rivermead Post-concussion Questionnaire at 2 weeks postinjury (ie, headache is at least a mild problem compared with pre-injury). Persistent PTH was defined when a patient with acute PTH reported a Rivermead Post-concussion Questionnaire headache score of greater than or equal to 2 at the scheduled follow-up examinations. RESULTS: Acute PTH was reported by 963 (60.4%) of 1594 patients with mTBI at 2 weeks postinjury. Among those with acute PTH, 439 (52.4%) of 837 patients reported persistent PTH at 3 months postinjury. This figure decreased over time and 278 (37.5%) of 742 patients continued to report persistent PTH at 6 months, whereas 187 (28.9%) of 646 patients did so as well at 12 months postinjury. Risk factors for acute PTH included younger age, female sex, fewer years of formal education, computed tomography-positive scans, alteration of consciousness, psychiatric history, and history of migraine. Risk factors for persistent PTH included female sex, fewer years of formal education, and history of migraine. CONCLUSION: Post-traumatic headache is a prevalent sequela of mTBI that persists for at least 12 months in a considerable proportion of affected individuals. The attributable burden necessitates better patient follow-up, disease characterization, improved awareness of PTH in clinical practice, and identification of effective therapies.

Diagnostic accuracy of serological and imaging tests used in surveillance for hepatocellular carcinoma in adults with cirrhosis: a systematic review protocol.

Background: Liver cirrhosis is the largest risk factor for developing hepatocellular carcinoma (HCC), and surveillance is therefore recommended among this population. Current guidance recommends surveillance with ultrasound, with or without alpha-fetoprotein (AFP). This review is part of a larger project looking at benefits, harms and costs of surveillance for HCC in people with cirrhosis. It aims to synthesise the evidence on the diagnostic accuracy of imaging or biomarker tests, alone or in combination, to identify HCC in adults with liver cirrhosis in a surveillance programme. Methods: We will identify studies through a 2021 Cochrane review with similar eligibility criteria, and a database search of MEDLINE, Embase and the Cochrane Database of Systematic Reviews. We will include diagnostic test accuracy studies with adult cirrhosis patients of any aetiology. Studies must assess at least one of the following index tests: ultrasound (US), magnetic resonance imaging (MRI), computerised tomography (CT), alpha-fetoprotein (AFP), des-gamma-carboxyprothrombin (DCP), lens culinaris agglutinin-reactive fraction of AFP (AFP-L3), a genomic biomarker, or a diagnostic prediction model incorporating at least one of the above-mentioned tests. We will assess studies for risk of bias using QUADAS-2 and QUADAS-C. We will combine data using bivariate random effects meta-analyses. For tests evaluated across varying diagnostic thresholds, we will produce pooled estimates of sensitivity and specificity across the full range of numerical thresholds, where possible. Where sufficient studies compare two or more index tests, we will perform additional analyses to compare the accuracy of different tests. Where feasible, we will stratify all meta-analyses by tumour size and patient characteristics, including cirrhosis aetiology and liver disease severity. Discussion: This review will synthesise evidence across the full range of possible surveillance tests, using advanced statistical methods to summarise accuracy across all thresholds and to compare the accuracy of different tests. PROSPERO registration: CRD42022357163.

Systematic reviews of convalescent plasma in COVID-19 continue to be poorly conducted and reported: a systematic review.

OBJECTIVES: To suggest possible approaches to combatting the impact of the COVID-19 infodemic to prevent research waste in future health emergencies and in everyday research and practice. STUDY DESIGN AND SETTING: Systematic review. The Epistemonikos database was searched in June 2021 for systematic reviews on the effectiveness of convalescent plasma for COVID-19. Two reviewers independently screened the retrieved references with disagreements resolved by discussion. Data extraction was completed by one reviewer with a proportion checked by a second. We used the Assessment of Multiple Systematic Reviews to assess the quality of conduct and reporting of included reviews. RESULTS: Fifty one systematic reviews are included with 193 individual studies included within the systematic reviews. There was considerable duplication of effort; multiple reviews were conducted at the same time with inconsistencies in the evidence included. The reviews were of low methodological quality, poorly reported, and did not adhere to preferred reporting items for systematic reviews and meta-analysis guidance. CONCLUSION: Researchers need to conduct, appraise, interpret, and disseminate systematic reviews better. All in the research community (researchers, peer-reviewers, journal editors, funders, decision makers, clinicians, journalists, and the public) need to work together to facilitate the conduct of robust systematic reviews that are published and communicated in a timely manner, reducing research duplication and waste, increasing transparency and accessibility of all systematic reviews.

Use of Clinical Pathway Simulation and Machine Learning to Identify Key Levers for Maximizing the Benefit of Intravenous Thrombolysis in Acute Stroke.

BACKGROUND: Expert opinion is that about 20% of emergency stroke patients should receive thrombolysis. Currently, 11% to 12% of patients in England and Wales receive thrombolysis, ranging from 2% to 24% between hospitals. The aim of this study was to assess how much variation is due to differences in local patient populations, and how much is due to differences in clinical decision-making and stroke pathway performance, while estimating a realistic target thrombolysis use. METHODS: Anonymised data for 246 676 emergency stroke admissions to 132 acute hospitals in England and Wales between 2016 and 2018 was obtained from the Sentinel Stroke National Audit Programme data. We used machine learning to learn decisions on who to give thrombolysis to at each hospital. We used clinical pathway simulation to model effects of changing pathway performance. Qualitative research was used to assess clinician attitudes to these methods. Three changes were modeled: (1) arrival-to-treatment in 30 minutes, (2) proportion of patients with determined stroke onset times set to at least the national upper quartile, (3) thrombolysis decisions made based on majority vote of a benchmark set of hospitals. RESULTS: Of the modeled changes, any single change was predicted to increase national thrombolysis use from 11.6% to between 12.3% to 14.5% (clinical decision-making having the most effect). Combined, these changes would be expected to increase thrombolysis to 18.3%, but there would still be significant variation between hospitals depending on local patient population. Clinicians engaged well with the modeling, but those from hospitals with lower thrombolysis use were most cautious about the methods. CONCLUSIONS: Machine learning and clinical pathway simulation may be applied at scale to national stroke audit data, allowing extended use and analysis of audit data. Stroke thrombolysis rates of at least 18% look achievable in England and Wales, but each hospital should have its own target.

National implementation of reperfusion for acute ischaemic stroke in England: How should services be configured? A modelling study.

Objectives: To guide policy when planning thrombolysis (IVT) and thrombectomy (MT) services for acute stroke in England, focussing on the choice between 'mothership' (direct conveyance to an MT centre) and 'drip-and-ship' (secondary transfer) provision and the impact of bypassing local acute stroke centres. Design: Outcome-based modelling study. Setting: 107 acute stroke centres in England, 24 of which provide IVT and MT (IVT/MT centres) and 83 provide only IVT (IVT-only units). Participants: 242,874 emergency admissions with acute stroke over 3 years (2015-2017). Intervention: Reperfusion delivered by drip-and-ship, mothership or 'hybrid' models; impact of additional travel time to directly access an IVT/MT centre by bypassing a more local IVT-only unit; effect of pre-hospital selection for large artery occlusion (LAO). Main outcome measures: Population benefit from reperfusion, time to IVT and MT, admission numbers to IVT-only units and IVT/MT centres. Results: Without pre-hospital selection for LAO, 94% of the population of England live in areas where the greatest clinical benefit, assuming unknown patient status, accrues from direct conveyance to an IVT/MT centre. However, this policy produces unsustainable admission numbers at these centres, with 78 out of 83 IVT-only units receiving fewer than 300 admissions per year (compared to 3 with drip-and-ship). Implementing a maximum permitted additional travel time to bypass an IVT-only unit, using a pre-hospital test for LAO, and selecting patients based on stroke onset time, all help to mitigate the destabilising effect but there is still some significant disruption to admission numbers, and improved selection of patients suitable for MT selectively reduces the number of patients who would receive IVT at IVT-only centres, challenging the sustainability of IVT expertise in IVT-only centres. Conclusions: Implementation of reperfusion for acute stroke based solely on achieving the maximum population benefit potentially leads to destabilisation of the emergency stroke care system. Careful planning is required to create a sustainable system, and modelling may be used to help planners maximise benefit from reperfusion while creating a sustainable emergency stroke care system.

Usefulness of Multisite Ventricular Pacing in Nonresponders to Cardiac Resynchronization Therapy.

Cardiac resynchronization therapy (CRT) is an established treatment for heart failure patients with myocardial dysfunction and delayed ventricular activation, but approximately 25% to 40% of patients do not respond to CRT. Left ventricular (LV) multisite pacing (MSP) has been proposed as a tool to improve CRT response. The goal of this study is to examine the safety and efficacy of LV MSP in CRT nonresponders. Between January 2018, and September 2019, the Strategic Management to Improve CRT Using Multi-Site Pacing trial prospectively enrolled 584 CRT-defibrillator recipients for established indications at 52 sites across the United States and evaluated their response at 6 months using the clinical composite score (CCS). Of the nonresponders, 102 patients had the LV MSP feature turned on and 78 patients completed the 12-month CCS evaluation. The LV MSP feature-related complication-free rate was 99.0% with a lower 95% confidence interval limit of 94.9%, which was higher than the performance goal of 90%. The proportion of nonresponders with an improved CCS from 6 to 12 months was 51.3% with a lower 95% confidence interval limit of 41.4%, which was higher than the performance goal of 5%. The estimated mean reduction in battery longevity with the LV MSP feature was about 3.6 months (estimated battery longevity of 8.87 ± 2.08 years at 6 months and 8.07 ± 2.23 years at 12 months). In conclusion, in CRT nonresponders, the use of the LV MSP feature is safe and associated with a ∼50% conversion rate with a small projected reduction in CRT-defibrillator battery longevity. LV MSP should be considered in the management of CRT nonresponders.

Characteristics, quality and volume of the first 5 months of the COVID-19 evidence synthesis infodemic: a meta-research study.

OBJECTIVE: The academic and scientific community has reacted at pace to gather evidence to help and inform about COVID-19. Concerns have been raised about the quality of this evidence. The aim of this review was to map the nature, scope and quality of evidence syntheses on COVID-19 and to explore the relationship between review quality and the extent of researcher, policy and media interest. DESIGN AND SETTING: A meta-research: systematic review of reviews. INFORMATION SOURCES: PubMed, Epistemonikos COVID-19 evidence, the Cochrane Library of Systematic Reviews, the Cochrane COVID-19 Study Register, EMBASE, CINAHL, Web of Science Core Collection and the WHO COVID-19 database, searched between 10 June 2020 and 15 June 2020. ELIGIBILITY CRITERIA: Any peer-reviewed article reported as a systematic review, rapid review, overview, meta-analysis or qualitative evidence synthesis in the title or abstract addressing a research question relating to COVID-19. Articles described as meta-analyses but not undertaken as part of a systematic or rapid review were excluded. STUDY SELECTION AND DATA EXTRACTION: Abstract and full text screening were undertaken by two independent reviewers. Descriptive information on review type, purpose, population, size, citation and attention metrics were extracted along with whether the review met the definition of a systematic review according to six key methodological criteria. For those meeting all criteria, additional data on methods and publication metrics were extracted. RISK OF BIAS: For articles meeting all six criteria required to meet the definition of a systematic review, AMSTAR-2 ((A MeaSurement Tool to Assess systematic Reviews, version 2.0) was used to assess the quality of the reported methods. RESULTS: 2334 articles were screened, resulting in 280 reviews being included: 232 systematic reviews, 46 rapid reviews and 2 overviews. Less than half reported undertaking critical appraisal and a third had no reproducible search strategy. There was considerable overlap in topics, with discordant findings. Eighty-eight of the 280 reviews met all six systematic review criteria. Of these, just 3 were rated as of moderate or high quality on AMSTAR-2, with the majority having critical flaws: only a third reported registering a protocol, and less than one in five searched named COVID-19 databases. Review conduct and publication were rapid, with 52 of the 88 systematic reviews reported as being conducted within 3 weeks, and a half published within 3 weeks of submission. Researcher and media interest, as measured by altmetrics and citations, was high, and was not correlated with quality. DISCUSSION: This meta-research of early published COVID-19 evidence syntheses found low-quality reviews being published at pace, often with short publication turnarounds. Despite being of low quality and many lacking robust methods, the reviews received substantial attention across both academic and public platforms, and the attention was not related to the quality of review methods. INTERPRETATION: Flaws in systematic review methods limit the validity of a review and the generalisability of its findings. Yet, by being reported as 'systematic reviews', many readers may well regard them as high-quality evidence, irrespective of the actual methods undertaken. The challenge especially in times such as this pandemic is to provide indications of trustworthiness in evidence that is available in 'real time'. PROSPERO REGISTRATION NUMBER: CRD42020188822.

Patient experience of telemedicine for headache care during the COVID-19 pandemic: An American Migraine Foundation survey study.

OBJECTIVE: We sought to investigate the patient experience of telemedicine for headache care during the coronavirus disease 2019 (COVID-19) pandemic. BACKGROUND: The use of telemedicine has rapidly expanded and evolved since the beginning of the COVID-19 pandemic. Telemedicine eliminates the physical and geographic barriers to health care, preserves personal protective equipment, and prevents the spread of COVID-19 by allowing encounters to happen in a socially distanced way. However, few studies have assessed the patient perspective of telemedicine for headache care. METHODS: The American Migraine Foundation (AMF) designed a standardized electronic questionnaire to assess the patient experience of telemedicine for headache care between March and September 2020 to help inform future quality improvement as part of its patient advocacy initiative. The date parameters were identified as the emergence of severe acute respiratory syndrome coronavirus 2 disease and the declaration of a national emergency in the United States. The questionnaire was distributed electronically to more than 100,000 members of the AMF community through social media platforms and the AMF email database. RESULTS: A total of 1172 patients responded to our electronic questionnaire, with 1098 complete responses. The majority, 1081/1153 (93.8%) patients, had a previous headache diagnosis prior to the telemedicine encounter. A total of 648/1127 (57.5%) patients reported that they had used telemedicine for headache care during the study period. Among those who participated in telehealth visits, 553/647 (85.5%) patients used it for follow-up visits; 94/647 (14.5%) patients used it for new patient visits. During the telemedicine encounters, 282/645 (43.7%) patients were evaluated by headache specialists, 222/645 (34.4%) patients by general neurologists, 198/645 (30.7%) patients by primary care providers, 73/645 (11.3%) patients by headache nurse practitioners, and 21/645 (3.2%) patients by headache nurses. Only 47/633 (7.4%) patients received a new headache diagnosis from telemedicine evaluation, whereas the other 586/633 (92.6%) patients did not have a change in their diagnoses. During these visits, a new treatment was prescribed for 358/636 (52.3%) patients, whereas 278/636 (43.7%) patients did not have changes made to their treatment plan. The number (%) of patients who rated the telemedicine headache care experience as "very good," "good," "fair," "poor," and "other" were 396/638 (62.1%), 132/638 (20.7%), 67/638 (10.5%), 23/638 (3.6%), and 20/638 (3.1%), respectively. Detailed reasons for "other" are listed in the manuscript. Most patients, 573/638 (89.8%), indicated that they would prefer to continue to use telemedicine for their headache care, 45/638 (7.1%) patients would not, and 20/638 (3.1%) patients were unsure. CONCLUSIONS: Our study evaluating the patient perspective demonstrated that telemedicine facilitated headache care for many patients during the COVID-19 pandemic, resulting in high patient satisfaction rates, and a desire to continue to use telemedicine for future headache care among those who completed the online survey.

Patient-initiated appointment systems for adults with chronic conditions in secondary care.

BACKGROUND: Missed hospital outpatient appointments is a commonly reported problem in healthcare services around the world; for example, they cost the National Health Service (NHS) in the UK millions of pounds every year and can cause operation and scheduling difficulties worldwide. In 2002, the World Health Organization (WHO) published a report highlighting the need for a model of care that more readily meets the needs of people with chronic conditions. Patient-initiated appointment systems may be able to meet this need at the same time as improving the efficiency of hospital appointments. OBJECTIVES: To assess the effects of patient-initiated appointment systems compared with consultant-led appointment systems for people with chronic or recurrent conditions managed in secondary care. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and six other databases. We contacted authors of identified studies and conducted backwards and forwards citation searching. We searched for current/ongoing research in two trial registers. Searches were run on 13 March 2019. SELECTION CRITERIA: We included randomised trials, published and unpublished in any language that compared the use of patient-initiated appointment systems to consultant-led appointment systems for adults with chronic or recurrent conditions managed in secondary care if they reported one or more of the following outcomes: physical measures of health status or disease activity (including harms), quality of life, service utilisation or cost, adverse effects, patient or clinician satisfaction, or failures of the 'system'. DATA COLLECTION AND ANALYSIS: Two review authors independently screened all references at title/abstract stage and full-text stage using prespecified inclusion criteria. We resolved disagreements though discussion. Two review authors independently completed data extraction for all included studies. We discussed and resolved discrepancies with a third review author. Where needed, we contacted authors of included papers to provide more information. Two review authors independently assessed the risk of bias using the Cochrane Effective Practice and Organisation of Care 'Risk of bias' tool, resolving any discrepancies with a third review author. Two review authors independently assessed the certainty of the evidence using GRADE. MAIN RESULTS: The 17 included randomised trials (3854 participants; mean age 41 to 76 years; follow-up 12 to 72 months) covered six broad health conditions: cancer, rheumatoid arthritis, asthma, chronic obstructive pulmonary disease, psoriasis and inflammatory bowel disease. The certainty of the evidence using GRADE ratings was mainly low to very low. The results suggest that patient-initiated clinics may make little or no difference to anxiety (odds ratio (OR) 0.87, 95% confidence interval (CI) 0.68 to 1.12; 5 studies, 1019 participants; low-certainty evidence) or depression (OR 0.79 95% CI 0.51 to 1.23; 6 studies, 1835 participants; low-certainty evidence) compared to the consultant-led appointment system. The results also suggest that patient-initiated clinics may make little or no difference to quality of life (standardised mean difference (SMD) 0.12, 95% CI 0.00 to 0.25; 7 studies, 1486 participants; low-certainty evidence) compared to the consultant-led appointment system. Results for service utilisation (contacts) suggest there may be little or no difference in service utilisation in terms of contacts between the patient-initiated and consultant-led appointment groups; however, the effect is not certain as the rate ratio ranged from 0.68 to 3.83 across the studies (median rate ratio 1.11, interquartile (IQR) 0.93 to 1.37; 15 studies, 3348 participants; low-certainty evidence). It is uncertain if service utilisation (costs) are reduced in the patient-initiated compared to the consultant-led appointment groups (8 studies, 2235 participants; very low-certainty evidence). The results suggest that adverse events such as relapses in some conditions (inflammatory bowel disease and cancer) may have little or no reduction in the patient-initiated appointment group in comparison with the consultant-led appointment group (MD -0.20, 95% CI -0.54 to 0.14; 3 studies, 888 participants; low-certainty evidence). The results are unclear about any differences the intervention may make to patient satisfaction (SMD 0.05, 95% CI -0.41 to 0.52; 2 studies, 375 participants) because the certainty of the evidence is low, as each study used different questions to collect their data at different time points and across different health conditions. Some areas of risk of bias across all the included studies was consistently high (i.e. for blinding of participants and personnel and blinding of outcome assessment, other areas were largely of low risk of bias or were affected by poor reporting making the assessment unclear). AUTHORS' CONCLUSIONS: Patient-initiated appointment systems may have little or no effect on patient anxiety, depression and quality of life compared to consultant-led appointment systems. Other aspects of disease status and experience also appear to show little or no difference between patient-initiated and consultant-led appointment systems. Patient-initiated appointment systems may have little or no effect on service utilisation in terms of service contact and there is uncertainty about costs compared to consultant-led appointment systems. Patient-initiated appointment systems may have little or no effect on adverse events such as relapse or patient satisfaction compared to consultant-led appointment systems.

'Not clinically effective but cost-effective' - paradoxical conclusions in randomised controlled trials with 'doubly null' results: a cross-sectional study.

OBJECTIVES: Randomised controlled trials in healthcare increasingly include economic evaluations. Some show small differences which are not statistically significant. Yet these sometimes come to paradoxical conclusions such as: 'the intervention is not clinically effective' but 'is probably cost-effective'. This study aims to quantify the extent of non-significant results and the types of conclusions drawn from them. DESIGN: Cross-sectional retrospective analysis of randomised trials published by the UK's National Institute for Health Research (NIHR) Health Technology Assessment programme. We defined as 'doubly null' those trials that found non-statistically significant differences in both primary outcome and cost per patient. Paradoxical was defined as concluding in favour of an intervention, usually compared with placebo or usual care. No human participants were involved. Our sample was 226 randomised trial projects published by the Health Technology Assessment programme 2004 to 2017. All are available free online. RESULTS: The 226 projects contained 193 trials with a full economic evaluation. Of these 76 (39%) had at least one 'doubly null' comparison. These 76 trials contained 94 comparisons. In these 30 (32%) drew economic conclusions in favour of an intervention. Overall report conclusions split roughly equally between those favouring the intervention (14), and those favouring either the control (7) or uncertainty (9). DISCUSSION: Trials with 'doubly null' results and paradoxical conclusions are not uncommon. The differences observed in cost and quality-adjustedlife year were small and non-statistically significant. Almost all these trials were also published in leading peer-reviewed journals. Although some guidelines for reporting economic results require cost-effectiveness estimates regardless of statistical significance, the interpretability of paradoxical results has nowhere been addressed. CONCLUSIONS: Reconsideration is required of the interpretation of cost-effectiveness analyses in randomised controlled trials with 'doubly null' results, particularly when economics favours a novel intervention.

Effectiveness of pharmacist home visits for individuals at risk of medication-related problems: a systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: Medication mismanagement is a major cause of both hospital admission and nursing home placement of frail older adults. Medication reviews by community pharmacists aim to maximise therapeutic benefit but also minimise harm. Pharmacist-led medication reviews have been the focus of several systematic reviews, but none have focussed on the home setting. REVIEW METHODS: To determine the effectiveness of pharmacist home visits for individuals at risk of medication-related problems we undertook a systematic review and meta-analysis of randomised controlled trials (RCTs). Thirteen databases were searched from inception to December 2018. Forward and backward citation of included studies was also performed. Articles were screened for inclusion independently by two reviewers. Randomised controlled studies of home visits by pharmacists for individuals at risk of medication-related problems were eligible for inclusion. Data extraction and quality appraisal were performed by one reviewer and checked by a second. Random-effects meta-analyses were performed where sufficient data allowed and narrative synthesis summarised all remaining data. RESULTS: Twelve RCTs (reported in 15 articles), involving 3410 participants, were included in the review. The frequency, content and purpose of the home visit varied considerably. The data from eight trials were suitable for meta-analysis of the effects on hospital admissions and mortality, and from three trials for the effects on quality of life. Overall there was no evidence of reduction in hospital admissions (risk ratio (RR) of 1.01 (95%CI 0.86 to 1.20, I2 = 69.0%, p = 0.89; 8 studies, 2314 participants)), or mortality (RR of 1.01 (95%CI 0.81 to 1.26, I2 = 0%, p = 0.94; 8 studies, 2314 participants)). There was no consistent evidence of an effect on quality of life, medication adherence or knowledge. CONCLUSION: A systematic review of twelve RCTs assessing the impact of pharmacist home visits for individuals at risk of medication related problems found no evidence of effect on hospital admission or mortality rates, and limited evidence of effect on quality of life. Future studies should focus on using more robust methods to assess relevant outcomes.

Estimating the effectiveness and cost-effectiveness of establishing additional endovascular Thrombectomy stroke Centres in England: a discrete event simulation.

BACKGROUND: We have previously modelled that the optimal number of comprehensive stroke centres (CSC) providing endovascular thrombectomy (EVT) in England would be 30 (net 6 new centres). We now estimate the relative effectiveness and cost-effectiveness of increasing the number of centres from 24 to 30. METHODS: We constructed a discrete event simulation (DES) to estimate the effectiveness and lifetime cost-effectiveness (from a payer perspective) using 1 year's incidence of stroke in England. 2000 iterations of the simulation were performed comparing baseline 24 centres to 30. RESULTS: Of 80,800 patients admitted to hospital with acute stroke/year, 21,740 would be affected by the service reconfiguration. The median time to treatment for eligible early presenters (< 270 min since onset) would reduce from 195 (IQR 155-249) to 165 (IQR 105-224) minutes. Our model predicts reconfiguration would mean an additional 33 independent patients (modified Rankin scale [mRS] 0-1) and 30 fewer dependent/dead patients (mRS 3-6) per year. The net addition of 6 centres generates 190 QALYs (95%CI - 6 to 399) and results in net savings to the healthcare system of £1,864,000/year (95% CI -1,204,000 to £5,017,000). The estimated budget impact was a saving of £980,000 in year 1 and £7.07 million in years 2 to 5. CONCLUSION: Changes in acute stroke service configuration will produce clinical and cost benefits when the time taken for patients to receive treatment is reduced. Benefits are highly likely to be cost saving over 5 years before any capital investment above £8 million is required.

Can clinical audits be enhanced by pathway simulation and machine learning? An example from the acute stroke pathway.

OBJECTIVE: To evaluate the application of clinical pathway simulation in machine learning, using clinical audit data, in order to identify key drivers for improving use and speed of thrombolysis at individual hospitals. DESIGN: Computer simulation modelling and machine learning. SETTING: Seven acute stroke units. PARTICIPANTS: Anonymised clinical audit data for 7864 patients. RESULTS: Three factors were pivotal in governing thrombolysis use: (1) the proportion of patients with a known stroke onset time (range 44%-73%), (2) pathway speed (for patients arriving within 4 hours of onset: per-hospital median arrival-to-scan ranged from 11 to 56 min; median scan-to-thrombolysis ranged from 21 to 44 min) and (3) predisposition to use thrombolysis (thrombolysis use ranged from 31% to 52% for patients with stroke scanned with 30 min left to administer thrombolysis). A pathway simulation model could predict the potential benefit of improving individual stages of the clinical pathway speed, whereas a machine learning model could predict the benefit of 'exporting' clinical decision making from one hospital to another, while allowing for differences in patient population between hospitals. By applying pathway simulation and machine learning together, we found a realistic ceiling of 15%-25% use of thrombolysis across different hospitals and, in the seven hospitals studied, a realistic opportunity to double the number of patients with no significant disability that may be attributed to thrombolysis. CONCLUSIONS: National clinical audit may be enhanced by a combination of pathway simulation and machine learning, which best allows for an understanding of key levers for improvement in hyperacute stroke pathways, allowing for differences between local patient populations. These models, based on standard clinical audit data, may be applied at scale while providing results at individual hospital level. The models facilitate understanding of variation and levers for improvement in stroke pathways, and help set realistic targets tailored to local populations.

Maximising access to thrombectomy services for stroke in England: A modelling study.

PURPOSE: Both intravenous thrombolysis (IVT) and intra-arterial endovascular thrombectomy (ET) improve the outcome of patients with acute ischaemic stroke, with endovascular thrombectomy being an option for those patients with large vessel occlusions. We sought to understand how organisation of services affects time to treatment for both intravenous thrombolysis and endovascular thrombectomy. METHOD: A multi-objective optimisation approach was used to explore the relationship between the number of intravenous thrombolysis and endovascular thrombectomy centres and times to treatment. The analysis is based on 238,887 emergency stroke admissions in England over 3 years (2013-2015). RESULTS: Providing hyper-acute care only in comprehensive stroke centres (CSC, providing both intravenous thrombolysis and endovascular thrombectomy, and performing >150 endovascular thrombectomy per year, maximum 40 centres) in England would lead to 15% of patients being more than 45 min away from care, and would create centres with up to 4300 stroke admissions/year. Mixing hyper-acute stroke units (providing intravenous thrombolysis only) with comprehensive stroke centres speeds time to intravenous thrombolysis and mitigates admission numbers to comprehensive stroke centres, but at the expense of increasing time to endovascular thrombectomy. With 24 comprehensive stroke centres and all remaining current acute stroke units as hyper-acute stroke units, redirecting patients directly to attend a comprehensive stroke centre by accepting a small delay (15-min maximum) in intravenous thrombolysis reduces time to endovascular thrombectomy: 25% of all patients would be redirected from hyper-acute stroke units to a comprehensive stroke centre, with an average delay in intravenous thrombolysis of 8 min, and an average improvement in time to endovascular thrombectomy of 80 min. The balance of comprehensive stroke centre:hyper-acute stroke unit admissions would change from 24:76 to 49:51. CONCLUSION: Planning of hyper-acute stroke services is best achieved when considering all forms of acute care and ambulance protocol together. Times to treatment need to be considered alongside manageable and sustainable admission numbers.

How do "robopets" impact the health and well-being of residents in care homes? A systematic review of qualitative and quantitative evidence.

BACKGROUND: Robopets are small animal-like robots which have the appearance and behavioural characteristics of pets. OBJECTIVE: To bring together the evidence of the experiences of staff, residents and family members of interacting with robopets and the effects of robopets on the health and well-being of older people living in care homes. DESIGN: Systematic review of qualitative and quantitative research. DATA SOURCES: We searched 13 electronic databases from inception to July 2018 and undertook forward and backward citation chasing. METHODS: Eligible studies reported the views and experiences of robopets from residents, family members and staff (qualitative studies using recognised methods of qualitative data collection and analysis) and the effects of robopets on the health and well-being of care home residents (randomised controlled trials, randomised crossover trials and cluster randomised trials). Study selection was undertaken independently by two reviewers. We used the Wallace criteria and the Cochrane Risk of Bias tool to assess the quality of the evidence. We developed a logic model with stakeholders and used this as a framework to guide data extraction and synthesis. Where appropriate, we used meta-analysis to combine effect estimates from quantitative studies. RESULTS: Nineteen studies (10 qualitative, 2 mixed methods and 7 randomised trials) met the inclusion criteria. Interactions with robopets were described as having a positive impact on aspects of well-being including loneliness, depression and quality of life by residents and staff, although there was no corresponding statistically significant evidence from meta-analysis for these outcomes. Meta-analysis showed evidence of a reduction in agitation with the robopet "Paro" compared to control (-0.32 [95% CI -0.61 to -0.04, p = 0.03]). Not everyone had a positive experience of robopets. CONCLUSIONS: Engagement with robopets appears to have beneficial effects on the health and well-being of older adults living in care homes, but not all chose to engage. Whether the benefits can be sustained are yet to be investigated. IMPLICATIONS FOR PRACTICE: Robopets have the potential to benefit people living in care homes, through increasing engagement and interaction. With the robopet acting as a catalyst, this engagement and interaction may afford comfort and help reduce agitation and loneliness.