From polarity to plurality: Perceptions of COVID-19 and policy measures in England and Scotland.

AIM: The aim of this study was to uncover perspectives on the COVID-19 pandemic and the responses implemented by the UK and Scottish Governments to help control the spread of infection. Such understanding could help to inform future responses to pandemics at individual, community and national levels. METHOD: Q methodology was used to elicit perspectives from people in England and Scotland with different experiences of the pandemic including public health officials, key workers, those on furlough, those who were unvaccinated or vaccinated to different levels, those who were 'shielding' because they were at higher risk and people with different scientific expertise. Participants rank-ordered phrases about different aspects of COVID-19 according to their viewpoint. Factor analysis was then conducted in conjunction with interview material from the same respondents. RESULTS: A four-factor solution was statistically supported and was interpretable alongside the qualitative accounts of participants loading on these factors. These four perspectives are titled Dangerous and Unaccountable Leadership, Fear and Anger at Policy and Public responses, Governing Through a Crisis and Injustices Exposed. CONCLUSION: The four perspectives demonstrate plurality and nuance in views on COVID-19 and the associated policies and restrictions, going beyond a binary narrative that has been apparent in popular and social media. The four perspectives include some areas of common ground, as well as disagreement. We argue that understanding the detail of different perspectives might be used to build cohesion around policy initiatives in future. PATIENT OR PUBLIC CONTRIBUTION: The development of the statement set, which is rank-ordered by participants in a Q study, and factor interpretations were informed by views of the general public. The statement set was initially developed using existing publicly available material based on members of the general public experiencing the pandemic first hand. It was then piloted with members of the public experiencing different challenges as a result of COVID-19 and the subsequent lockdown and updated based on feedback. Finally, interpretations of the identified factors were presented publicly and edited according to their feedback.

Cost-effectiveness of 2 Models of Pessary Care for Pelvic Organ Prolapse: Findings From the TOPSY Randomized Controlled Trial.

OBJECTIVES: Pelvic organ prolapse is the descent of one or more reproductive organs from their normal position, causing associated negative symptoms. One conservative treatment option is pessary management. This study aimed to to investigate the cost-effectiveness of pessary self-management (SM) when compared with clinic-based care (CBC). A decision analytic model was developed to extend the economic evaluation. METHODS: A randomized controlled trial with health economic evaluation. The SM group received a 30-minute SM teaching session, information leaflet, 2-week follow-up call, and a local helpline number. The CBC group received routine outpatient pessary appointments, determined by usual practice. The primary outcome for the cost-effectiveness analysis was incremental cost per quality-adjusted life year (QALY), 18 months post-randomization. Uncertainty was handled using nonparametric bootstrap analysis. In addition, a simple decision analytic model was developed using the trial data to extend the analysis over a 5-year period. RESULTS: There was no significant difference in the mean number of QALYs gained between SM and CBC (1.241 vs 1.221), but mean cost was lower for SM (£578 vs £728). The incremental net benefit estimated at a willingness to pay of £20 000 per QALY gained was £564, with an 80.8% probability of cost-effectiveness. The modeling results were consistent with the trial analysis: the incremental net benefit was estimated as £4221, and the probability of SM being cost-effective at 5 years was 69.7%. CONCLUSIONS: Results suggest that pessary SM is likely to be cost-effective. The decision analytic model suggests that this result is likely to persist over longer durations.

Strategies used for childhood chronic functional constipation: the SUCCESS evidence synthesis.

Background: Up to 30% of children have constipation at some stage in their life. Although often short-lived, in one-third of children it progresses to chronic functional constipation, potentially with overflow incontinence. Optimal management strategies remain unclear. Objective: To determine the most effective interventions, and combinations and sequences of interventions, for childhood chronic functional constipation, and understand how they can best be implemented. Methods: Key stakeholders, comprising two parents of children with chronic functional constipation, two adults who experienced childhood chronic functional constipation and four health professional/continence experts, contributed throughout the research. We conducted pragmatic mixed-method reviews. For all reviews, included studies focused on any interventions/strategies, delivered in any setting, to improve any outcomes in children (0-18 years) with a clinical diagnosis of chronic functional constipation (excluding studies of diagnosis/assessment) included. Dual reviewers applied inclusion criteria and assessed risk of bias. One reviewer extracted data, checked by a second reviewer. Scoping review: We systematically searched electronic databases (including Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature) (January 2011 to March 2020) and grey literature, including studies (any design) reporting any intervention/strategy. Data were coded, tabulated and mapped. Research quality was not evaluated. Systematic reviews of the evidence of effectiveness: For each different intervention, we included existing systematic reviews judged to be low risk of bias (using the Risk of Bias Assessment Tool for Systematic Reviews), updating any meta-analyses with new randomised controlled trials. Where there was no existing low risk of bias systematic reviews, we included randomised controlled trials and other primary studies. The risk of bias was judged using design-specific tools. Evidence was synthesised narratively, and a process of considered judgement was used to judge certainty in the evidence as high, moderate, low, very low or insufficient evidence. Economic synthesis: Included studies (any design, English-language) detailed intervention-related costs. Studies were categorised as cost-consequence, cost-effectiveness, cost-utility or cost-benefit, and reporting quality evaluated using the consensus health economic criteria checklist. Systematic review of implementation factors: Included studies reported data relating to implementation barriers or facilitators. Using a best-fit framework synthesis approach, factors were synthesised around the consolidated framework for implementation research domains. Results: Stakeholders prioritised outcomes, developed a model which informed evidence synthesis and identified evidence gaps. Scoping review: 651 studies, including 190 randomised controlled trials and 236 primary studies, conservatively reported 48 interventions/intervention combinations. Effectiveness systematic reviews: studies explored service delivery models (n = 15); interventions delivered by families/carers (n = 32), wider children's workforce (n = 21), continence teams (n = 31) and specialist consultant-led teams (n = 42); complementary therapies (n = 15); and psychosocial interventions (n = 4). One intervention (probiotics) had moderate-quality evidence; all others had low to very-low-quality evidence. Thirty-one studies reported evidence relating to cost or resource use; data were insufficient to support generalisable conclusions. One hundred and six studies described implementation barriers and facilitators. Conclusions: Management of childhood chronic functional constipation is complex. The available evidence remains limited, with small, poorly conducted and reported studies. Many evidence gaps were identified. Treatment recommendations within current clinical guidelines remain largely unchanged, but there is a need for research to move away from considering effectiveness of single interventions. Clinical care and future studies must consider the individual characteristics of children. Study registration: This study is registered as PROSPERO CRD42019159008. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 128470) and is published in full in Health Technology Assessment; Vol. 28, No. 5. See the NIHR Funding and Awards website for further award information.

Between 5% and 30% of children experience constipation at some stage. In one-third of these children, this progresses to chronic functional constipation. Chronic functional constipation affects more children with additional needs. We aimed to find and bring together published information about treatments for chronic functional constipation, to help establish best treatments and treatment combinations. We did not cover assessment or diagnosis of chronic functional constipation. This project was guided by a 'stakeholder group', including parents of children with constipation, people who experienced constipation as children, and healthcare professionals/continence experts. We carried out a 'scoping review' and a series of 'systematic reviews'. Our 'scoping review' provides an overall picture of research about treatments, with 651 studies describing 48 treatments. This helps identify important evidence gaps. 'Systematic reviews' are robust methods of bringing together and interpreting research evidence. Our stakeholder group decided to structure our systematic reviews to reflect who delivered the interventions. We brought together evidence about how well treatments worked when delivered by families/carers (32 studies), the wider children's workforce (e.g. general practitioner, health visitor) (21 studies), continence teams (31 studies) or specialist consultant-led teams (42 studies). We also considered complementary therapies (15 studies) and behavioural strategies (4 studies). Care is affected by what is done and how it is done. We brought together evidence about different models of delivering care (15 studies), barriers and facilitators to implementation of treatments (106 studies) and costs (31 studies). Quality of evidence was mainly low to very low. Despite numerous studies, there was often insufficient information to support generalisable conclusions. Our findings generally agreed with current clinical guidelines. Management of childhood chronic functional constipation should be child-centred, multifaceted and adapted according to the individual child, their needs, the situation in which they live and the health-care setting in which they are looked after. Research is needed to address our identified evidence gaps.

Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial.

Background: Prolapse affects 30-40% of women. Those using a pessary for prolapse usually receive care as an outpatient. This trial determined effectiveness and cost-effectiveness of pessary self-management (SM) vs clinic-based care (CBC) in relation to condition-specific quality of life (QoL). Methods: Parallel-group, superiority randomised controlled trial, recruiting from 16 May 2018 to 7 February 2020, with follow-up to 17 September 2021. Women attending pessary clinics, ≥18 years, using a pessary (except Shelf, Gellhorn or Cube), with pessary retained ≥2 weeks were eligible. Limited manual dexterity; cognitive deficit; pregnancy; or requirement for non-English teaching were exclusions. SM group received a 30-min teaching session; information leaflet; 2-week follow-up call; and telephone support. CBC group received usual routine appointments. The primary clinical outcome was pelvic floor-specific QoL (PFIQ-7), and incremental net monetary benefit for cost-effectiveness, 18 months post-randomisation. Group allocation was by remote web-based application, minimised on age, user type (new/existing) and centre. Participants, intervention deliverers, researchers and the statistician were not blinded. The primary analysis was intention-to-treat based. Trial registration: https://doi.org/10.1186/ISRCTN62510577. Findings: The requisite 340 women were randomised (169 SM, 171 CBC) across 21 centres. There was not a statistically significant difference between groups in PFIQ-7 at 18 months (mean SM 32.3 vs CBC 32.5, adjusted mean difference SM-CBC -0.03, 95% CI -9.32 to 9.25). SM was less costly than CBC. The incremental net benefit of SM was £564 (SE £581, 95% CI -£576 to £1704). A lower percentage of pessary complications was reported in the SM group (mean SM 16.7% vs CBC 22.0%, adjusted mean difference -3.83%, 95% CI -6.86% to -0.81%). There was no meaningful difference in general self-efficacy. Self-managing women were more confident in self-management activities. There were no reported suspected unexpected serious adverse reactions, and 31 unrelated serious adverse events (17 SM, 14 CBC). Interpretation: Pessary self-management is cost-effective, does not improve or worsen QoL compared to CBC, and has a lower complication rate. Funding: National Institute for Health and Care Research, Health Technology Assessment Programme (16/82/01).

Cost consequence analysis of transcutaneous tibial nerve stimulation (TTNS) for urinary incontinence in care home residents alongside a randomised controlled trial.

BACKGROUND: Urinary incontinence (UI) is prevalent in more than half of residents of nursing and residential care homes and can have a detrimental impact on dignity and quality of life. Care homes predominantly use absorbent pads to contain UI rather than actively treat the condition. Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive, safe, low-cost intervention with demonstrated effectiveness for reducing UI in adults. We examined the costs and consequences of delivering TTNS to care home residents in comparison to sham (inactive) electrical stimulation. METHODS: A cost consequence analysis approach was used to assemble and present the resource use and outcome data for the ELECTRIC trial which randomised 406 residents with UI from 37 care homes in the United Kingdom to receive 12 sessions of 30 min of either TTNS or sham (inactive) TTNS. TTNS was administered by care home staff over 6 weeks. Health state utility was measured using DEMQOL-U and DEMQOL-PROXY-U at baseline, 6 weeks and 18 weeks follow-up. Staff completed a resource use questionnaire at baseline, 6 weeks and 18 weeks follow-up, which also assessed use of absorbent pads. RESULTS: HRQoL did not change significantly in either randomised group. Delivery of TTNS was estimated to cost £81.20 per participant, plus training and support costs of £121.03 per staff member. 85% of participants needed toilet assistance as routine, on average requiring one or two staff members to be involved 4 or 5 times in each 24 h. Daily use of mobility aids and other assistive devices to use the toilet were reported. The value of staff time to assist residents to use the toilet (assuming an average of 5 min per resident per visit) was estimated as £19.17 (SD 13.22) for TTNS and £17.30 (SD 13.33) for sham (per resident in a 24-hour period). CONCLUSIONS: Use of TTNS to treat UI in care home residents did not lead to changes in resource use, particularly any reduction in the use of absorbent pads and no cost benefits for TTNS were shown. Managing continence in care homes is labour intensive, requiring both high levels of staff time and use of equipment aids. TRIAL REGISTRATION: ISRCTN98415244, registered 25/04/2018. NCT03248362 (Clinical trial.gov number), registered 14/08//2017.

Impact of surgical-site infection on health utility values: a meta-analysis.

BACKGROUND: Surgical-site infections (SSIs) are recognized as negatively affecting patient quality of life. No meta-analysis of SSI utility values is available in the literature to inform estimates of this burden and investment decisions in prevention. METHODS: A systematic search of PubMed, MEDLINE, CINAHL, and the National Health Service Economic Evaluation Database was performed in April 2022 in accordance with PROSPERO registration CRD 42021262633. Studies were included where quality-of-life data were gathered from adults undergoing surgery, and such data were presented for those with and without an SSI at similar time points. Two researchers undertook data extraction and quality appraisal independently, with a third as arbiter. Utility values were converted to EuroQol 5D (EQ-5D™) estimates. Meta-analyses were conducted using a random-effects model across all relevant studies, with subgroup analyses on type and timing of the SSI. RESULTS: In total, 15 studies with 2817 patients met the inclusion criteria. Six studies across seven time points were used in the meta-analysis. The pooled mean difference in EQ-5D™ utility in all studies combined was -0.08 (95 per cent c.i. -0.11 to -0.05; prediction interval -0.16 to -0.01; I2 = 40 per cent). The mean difference in EQ-5D™ utility associated with deep SSI was -0.10 (95 per cent c.i. -0.14 to -0.06; I2 = 0 per cent) and the mean difference in EQ-5D™ utility persisted over time. CONCLUSION: The present study provides the first synthesized estimate of SSI burden over the short and long term. EQ-5D™ utility estimates for a range of SSIs are essential for infection prevention planning and future economic modelling.

Common health assets protocol: a mixed-methods, realist evaluation and economic appraisal of how community-led organisations (CLOs) impact on the health and well-being of people living in deprived areas.

INTRODUCTION: This research investigates how community-led organisations' (CLOs') use of assets-based approaches improves health and well-being, and how that might be different in different contexts. Assets-based approaches involve 'doing with' rather than 'doing to' and bring people in communities together to achieve positive change using their own knowledge, skills and experience. Some studies have shown that such approaches can have a positive effect on health and well-being. However, research is limited, and we know little about which approaches lead to which outcomes and how different contexts might affect success. METHODS AND ANALYSIS: Using a realist approach, we will work with 15 CLOs based in disadvantaged communities in England, Scotland and Northern Ireland. A realist synthesis of review papers, and a policy analysis in different contexts, precedes qualitative interviews and workshops with stakeholders, to find out how CLOs' programmes work and identify existing data. We will explore participants' experiences through: a Q methodology study; participatory photography workshops; qualitative interviews and measure outcomes using a longitudinal survey, with 225 CLO participants, to assess impact for people who connect with the CLOs. An economic analysis will estimate costs and benefits to participants, for different contexts and mechanisms. A 'Lived Experience Panel' of people connected with our CLOs as participants or volunteers, will ensure the appropriateness of the research, interpretation and reporting of findings. ETHICS AND DISSEMINATION: This project, research tools and consent processes have been approved by the Glasgow Caledonian University School of Health and Life Sciences Ethics Committee, and affirmed by Ethics Committees at Bournemouth University, Queen's University Belfast and the University of East London. Common Health Assets does not involve any National Health Service sites, staff or patients.Findings will be presented through social media, project website, blogs, policy briefings, journal articles, conferences and visually in short digital stories, and photographic exhibitions.

What is important in supporting self-management in community stroke rehabilitation? A Q methodology study.

PURPOSE: Supported self-management (SSM) is an important part of adapting to life after stroke however it is a complex concept. It is unclear what SSM in stroke consists of or how stroke survivors, families, and clinicians can most effectively work together to support person-centred self-management. In this study, we aimed to explore what was most important in making SSM work in community stroke rehabilitation. METHODS: We conducted a Q-methodology study with stroke survivors (n = 20), community-based stroke clinicians (n = 20), and team managers (n = 8) across four health boards in Scotland, United Kingdom. Participants ranked 32 statements according to their importance in making SSM work. Factor analysis was used to identify shared viewpoints. RESULTS: We identified four viewpoints: (i) A person-centred approach to build self-confidence and self-worth; (ii) Feeling heard, understood, and supported by everybody; (iii) Preparation of appropriate resources; and (iv) Right thing, right place, right time for the individual. Important across all viewpoints were: a trusting supportive relationship; working in partnership; focusing on meaningful goals; and building self-confidence. CONCLUSIONS: Differing views exist on what is most important in SSM. These views could be used to inform quality improvement strategies to support the delivery of SSM that considers the preferences of stroke survivors. IMPLICATIONS FOR REHABILITATIONClinicians should be aware of their own viewpoint of supported self-management and consider how their perspective may differ from stroke survivors' and colleagues' perspectives of what's important to support self-management.Working in partnership with stroke survivors plus developing a trusting and supportive relationship with them are core components of supporting self-management in the longer term after stroke.Building a sense of self-worth and self-confidence, a focus on meaningful goals, training and support for staff, and tailoring support to people's needs at the right time are important considerations for supporting longer-term engagement in self-management.

Long-term effects and costs of pelvic floor muscle training for prolapse: trial follow-up record-linkage study.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse affects around 40% of women aged over 50 years. A multicentre parallel group randomised trial (the Pelvic Organ Prolapse PhysiotherapY (POPPY) trial) demonstrated that pelvic floor muscle training (PFMT) was effective in reducing prolapse symptoms compared with no treatment. However, insight into the long-term impact of PFMT on health outcomes and health-service utilisation is scarce. METHODS: This study utilised linkage of Scottish administrative health records to follow-up POPPY trial participants resident in Scotland over 11 years. Mixed effects logistic regression determined the likelihood of receiving further prolapse treatment for those in the PFMT and control groups. Analyses were adjusted for age group, prolapse stage, baseline symptom severity and attitude towards surgery. A cost assessment estimated longitudinal costs to the UK National Health Service (in Scotland) of accessing further prolapse treatment for each trial group. RESULTS: Two hundred and ninety-three women, aged 25 to 79 years, were followed up. One hundred and forty-one women (48.1%) had received further prolapse treatment: 65 (of 149; 43.6%) in the PFMT group compared with 76 (of 144; 52.8%) in the control group. PFMT was associated with a reduction in the odds of any prolapse treatment during follow-up (AOR 0.61; 95% CI 0.37 to 0.99). Total cost of secondary care was £154,544 (GBP) in the PFMT group and £172,549 (GBP) in the control group. CONCLUSIONS: Although PFMT did not lead to significant differences in total costs for further prolapse treatment over a post-intervention period of more than 10 years, it reduced the overall long-term risk of requiring hospital-based treatment for pelvic floor disorders.

Stimulation of the tibial nerve-a randomised trial for urinary problems associated with Parkinson's-the STARTUP trial.

BACKGROUND: non-motor symptoms such as bladder dysfunction are common (80%) in people with Parkinson's increasing the risk for falls with a negative impact on health-related costs and quality of life.We undertook STARTUP to evaluate the clinical and cost-effectiveness of using an adhesive electrode to stimulate the transcutaneous tibial nerve stimulation (TTNS) to treat bladder dysfunction in people with Parkinson's disease (PD).Study design, materials and methods: STARTUP was a parallel two-arm, multi-centre, pragmatic, double-blind, randomised controlled trial. Each participant attended one clinic visit to complete consent, be randomised using a computer-generated system and to be shown how to use the device.The trial had two co-primary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score (IPSS). These were completed at baseline, 6 and 12 weeks. A bladder frequency chart and resource questionnaire were also completed. RESULTS: two hundred forty two participants were randomised. About 59% of participants were male, the mean age was 69 years and mean time since diagnosis was 6 years. Questionnaire return rate was between 79 and 90%.There was a statistically significantly lower score in the active group at 6 weeks in the IPSS questionnaire (mean difference (Standard deviation, SD) 12.5 (6.5) vs 10.9 (5.5), effect size -1.49, 95% CI -2.72, -0.25). There was no statistically significant change in any other outcome. CONCLUSION: TTNS was demonstrated to be safe with a high level of compliance. There was a significant change in one of the co-primary outcome measures at the end of the treatment period (i.e. 6 weeks), which could indicate a benefit. Further fully powered RCTs are required to determine effective treatments.

Gait rehabilitation for foot and ankle impairments in early rheumatoid arthritis: a feasibility study of a new gait rehabilitation programme (GREAT Strides).

BACKGROUND: Foot impairments in early rheumatoid arthritis are common and lead to progressive deterioration of lower limb function. A gait rehabilitation programme underpinned by psychological techniques to improve adherence, may preserve gait and lower limb function. This study evaluated the feasibility of a novel gait rehabilitation intervention (GREAT Strides) and a future trial. METHODS: This was a mixed methods feasibility study with embedded qualitative components. People with early (< 2 years) rheumatoid arthritis (RA) and foot pain were eligible. Intervention acceptability was evaluated using a questionnaire. Adherence was evaluated using the Exercise Adherence Rating Scale (EARS). Safety was monitored using case report forms. Participants and therapists were interviewed to explore intervention acceptability. Deductive thematic analysis was applied using the Theoretical Framework of Acceptability. For fidelity, audio recordings of interventions sessions were assessed using the Motivational Interviewing Treatment Integrity (MITI) scale. Measurement properties of four candidate primary outcomes, rates of recruitment, attrition, and data completeness were evaluated. RESULTS: Thirty-five participants (68.6% female) with median age (inter-quartile range [IQR]) 60.1 [49.4-68.4] years and disease duration 9.1 [4.0-16.2] months), were recruited and 23 (65.7%) completed 12-week follow-up. Intervention acceptability was excellent; 21/23 were confident that it could help and would recommend it; 22/23 indicated it made sense to them. Adherence was good, with a median [IQR] EARS score of 17/24 [12.5-22.5]. One serious adverse event that was unrelated to the study was reported. Twelve participants' and 9 therapists' interviews confirmed intervention acceptability, identified perceptions of benefit, but also highlighted some barriers to completion. Mean MITI scores for relational (4.38) and technical (4.19) aspects of motivational interviewing demonstrated good fidelity. The Foot Function Index disability subscale performed best in terms of theoretical consistency and was deemed most practical. CONCLUSION: GREAT Strides was viewed as acceptable by patients and therapists, and we observed high intervention fidelity, good patient adherence, and no safety concerns. A future trial to test the additional benefit of GREAT Strides to usual care will benefit from amended eligibility criteria, refinement of the intervention and strategies to ensure higher follow-up rates. The Foot Function Index disability subscale was identified as the primary outcome for the future trial. TRIAL REGISTRATION: ISRCTN14277030.

Supported self-management in community stroke rehabilitation: what is it and how does it work? A protocol for a realist evaluation study.

INTRODUCTION: A growing evidence base demonstrates the effectiveness of supported self-management in stroke for stroke survivors and their families. However, there is significant variation in its implementation in community stroke care and little understanding about how supported self-management works and is delivered across different settings, models used and contexts of community stroke rehabilitation. METHODS AND ANALYSIS: Using a mixed method, realist approach across two phases, this protocol describes a study on community-based supported self-management. The aim is to identify the mechanisms and outcomes of supported self-management in stroke and to understand how supported self-management is implemented in different contexts of community stroke rehabilitation. Phase 1 involves (1) a realist synthesis, (2) a scoping and mapping of current community rehabilitation settings and (3) a Q-methodology study to develop initial programme theories about how community-based supported self-management works, for whom and in what contexts. Phase 2 involves realist informed interviews/focus groups with stroke survivors, community rehabilitation practitioners and team managers from across Scotland to test and refine programme theories and an explanatory model for how supported self-management works across different contexts of community-based stroke rehabilitation. ETHICS AND DISSEMINATION: Ethical approval and R&D approvals have been granted from East of Scotland Research Ethics Committee (REC reference number: 19/ES/0055) and participating NHS boards. An understanding of how, for whom and in what contexts community-based supported self-management works will help to strengthen its delivery in practice. Such an understanding will enable the design of context-specific recommendations for policy and practice that genuinely reflect the challenges in implementing supported self-management in community stroke care. Results will be disseminated to clinical partners working in community stroke rehabilitation, stroke survivors and families and to policymakers and third sector partners involved in the provision of long-term support for people affected by stroke. PROSPERO REGISTRATION NUMBER: CRD42020166208.

A Pilot Study of Clinicians' Perceptions of Feasibility, Client-Centeredness, and Usability of the Systematic Tailored Assessment for Responding to Suicidality Protocol.

Background: The Systematic Tailored Assessment for Responding to Suicidality (STARS) is a client-centered, psychosocial needs-based assessment protocol. This semistructured interview obtains client prioritized indicators that contribute to suicidality and informs commensurate care responses for preventing suicide. Aim: To pilot the feasibility, client-centeredness, and usability of the STARS protocol, including clinicians' perceptions of ease of use; content validity; and administration within the community setting. Method: A convenience sample of clinicians who undertook assessment and/or intervention with suicidal persons and had used STARS between mid-2016 and early 2017 completed an online survey assessing feasibility, client-centeredness, and usability of STARS. Results: Of the 51 clinicians who entered the survey, 42 (82.3%; aged 25-74; 69% female) completed it. Overall, perceptions of feasibility and usability of STARS were positive, particularly regarding client-centeredness of the protocol and confidence in information obtained for screening suicidality and informing needs-based priority responses. Limitations: The pilot findings are limited by the use of a small convenience sample and the low completion rate of clinicians with STARS training. Conclusion: STARS was perceived as a feasible and useful psychosocial needs-based assessment protocol. Suggestions for improving STARS, training requirements, and application to diverse populations are outlined.

Probabilistic microsimulation to examine the cost-effectiveness of hospital admission screening strategies for carbapenemase-producing enterobacteriaceae (CPE) in the United Kingdom.

BACKGROUND: Antimicrobial resistance has been recognised as a global threat with carbapenemase- producing-Enterobacteriaceae (CPE) as a prime example. CPE has similarities to COVID-19 where asymptomatic patients may be colonised representing a source for onward transmission. There are limited treatment options for CPE infection leading to poor outcomes and increased costs. Admission screening can prevent cross-transmission by pre-emptively isolating colonised patients. OBJECTIVE: We assess the relative cost-effectiveness of screening programmes compared with no- screening. METHODS: A microsimulation parameterised with NHS Scotland date was used to model scenarios of the prevalence of CPE colonised patients on admission. Screening strategies were (a) two-step screening involving a clinical risk assessment (CRA) checklist followed by microbiological testing of high-risk patients; and (b) universal screening. Strategies were considered with either culture or polymerase chain reaction (PCR) tests. All costs were reported in 2019 UK pounds with a healthcare system perspective. RESULTS: In the low prevalence scenario, no screening had the highest probability of cost-effectiveness. Among screening strategies, the two CRA screening options were the most likely to be cost-effective. Screening was more likely to be cost-effective than no screening in the prevalence of 1 CPE colonised in 500 admitted patients or more. There was substantial uncertainty with the probabilities rarely exceeding 40% and similar results between strategies. Screening reduced non-isolated bed-days and CPE colonisation. The cost of screening was low in relation to total costs. CONCLUSION: The specificity of the CRA checklist was the parameter with the highest impact on the cost-effectiveness. Further primary data collection is needed to build models with less uncertainty in the parameters.

Co(NCS)2(abpt)2 and Ni(NCS)2(abpt)2 [abpt is 4-amino-3,5-bis(pyridin-2-yl)-1,2,4-triazole]: structural characterization of polymorphs A and B.

The synthesis and structures of bis[4-amino-3,5-bis(pyridin-2-yl)-1,2,4-triazole-κ2N2,N3]bis(thiocyanato-κN)cobalt(II), [Co(NCS)2(C12H10N6)2] or Co(NCS)2(abpt)2, and bis[4-amino-3,5-bis(pyridin-2-yl)-1,2,4-triazole-κ2N2,N3]bis(thiocyanato-κN)nickel(II), [Ni(NCS)2(C12H10N6)2] or Ni(NCS)2(abpt)2, are reported. In both cases, two polymorphs, A and B, were identified and structurally characterized. For both polymorphs, the structures obtained with the different metals, i.e. CoII or NiII, were found to be isostructural. All of the structures contained an intramolecular N-H...N hydrogen bond, C-H...N interactions and π-π stacking interactions. No structural evidence was observed for a thermal spin crossover for either of the Co(NCS)2(abpt)2 polymorphs between 300 (2) and 120 (2) K.

Selected solid-state behaviour of three di-tert-butyl-substituted N-salicylideneaniline derivatives: temperature-induced phase transitions and chromic behaviour.

The synthesis, single-crystal structures and chromic behaviour of three related Schiff bases, namely, (E)-2,4-di-tert-butyl-6-{[(4-fluorophenyl)imino]methyl}phenol, C21H26FNO, 1, (E)-2,4-di-tert-butyl-6-{[(4-chlorophenyl)imino]methyl}phenol, C21H26ClNO, 2, and (E)-6-{[(4-bromophenyl)imino]methyl}-2,4-di-tert-butylphenol, C21H26BrNO, 3, are reported. Two polymorphs of 1 were obtained, which were found to have different photochromic properties. Schiff bases 2 and 3 were found to be isostructural and underwent a phase transition upon cooling which was attributed to the dynamic disorder in one of the tert-butyl groups resolving at low temperature. All of the structures were found to exist in the enol rather than the keto form based on the C-O(H) and imine C=N bond lengths, and contained an intramolecular O-H...N hydrogen bond alongside weaker intermolecular C-H...O contacts.

Tibial nerve stimulation compared with sham to reduce incontinence in care home residents: ELECTRIC RCT.

BACKGROUND: Urinary incontinence is prevalent in nursing and residential care homes, and has a profound impact on residents' dignity and quality of life. Treatment options are limited in these care contexts and care homes predominantly use absorbent pads to contain incontinence, rather than actively treat it. Transcutaneous posterior tibial nerve stimulation is a non-invasive, safe, low-cost intervention that is effective in reducing urinary incontinence in adults. OBJECTIVE: To determine the clinical effectiveness of transcutaneous posterior tibial nerve stimulation to treat urinary incontinence in care home residents and to determine the associated costs of the treatment. DESIGN: A multicentre, pragmatic, participant and outcome assessor-blind, randomised placebo-controlled trial. SETTING: A total of 37 UK residential and nursing care homes. PARTICIPANTS: Care home residents with at least weekly urinary incontinence that is contained using absorbent pads and who are able to use a toilet/toilet aid with or without assistance. INTERVENTIONS: Residents were randomised (1 : 1) to receive 12 30-minute sessions of transcutaneous posterior tibial nerve stimulation or sham stimulation over a 6-week period. MAIN OUTCOME MEASURES: Primary outcome - change in volume of urine leaked over a 24-hour period at 6 weeks. Secondary outcomes - number of pads used, Perception of Bladder Condition, toileting skills, quality of life and resource use. RESULTS: A total of 408 residents were randomised (transcutaneous posterior tibial nerve stimulation, n = 197; sham stimulation, n = 209); two exclusions occurred post randomisation. Primary outcome data were available for 345 (85%) residents (transcutaneous posterior tibial nerve stimulation, n = 167; sham stimulation, n = 178). Adherence to the intervention protocol was as follows: 78% of the transcutaneous posterior tibial nerve stimulation group and 71% of the sham group received the correct stimulation. Primary intention-to-treat adjusted analysis indicated a mean change of -5 ml (standard deviation 362 ml) urine leakage from baseline in the transcutaneous posterior tibial nerve stimulation group and -66 ml (standard deviation 394 ml) urine leakage in the sham group, which was a statistically significant, but not clinically important, between-group difference of 68-ml urine leakage (95% confidence interval 0 to 136 ml; p = 0.05) in favour of the sham group. Sensitivity analysis supported the primary analysis. No meaningful differences were detected in any of the secondary outcomes. No serious adverse events related to transcutaneous posterior tibial nerve stimulation were reported. Economic evaluation assessed the resources used. The training and support costs for the staff to deliver the intervention were estimated at £121.03 per staff member. Estimated costs for delivery of transcutaneous posterior tibial nerve stimulation during the trial were £81.20 per participant. No significant difference was found between participants' scores over time, or between transcutaneous posterior tibial nerve stimulation and sham groups at any time point, for resident or proxy quality-of-life measures. CONCLUSIONS: The ELECTRIC (ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes) trial showed, in the care home context (with a high proportion of residents with poor cognitive capacity and limited independent mobility), that transcutaneous posterior tibial nerve stimulation was not effective in reducing urinary incontinence. No economic case for transcutaneous posterior tibial nerve stimulation was made by the cost-consequences analysis; however, the positive reception of learning about urinary incontinence for care home staff supports a case for routine education in this care context. LIMITATIONS: Completing 24-hour pad collections was challenging for care home staff, resulting in some missing primary outcome data. FUTURE WORK: Research should investigate transcutaneous posterior tibial nerve stimulation in residents with urgency urinary incontinence to determine whether or not targeted stimulation is effective. Research should evaluate the effects of continence training for staff on continence care in care homes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN98415244 and ClinicalTrials.gov NCT03248362. 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. 25, No. 41. See the NIHR Journals Library website for further project information.

Bladder leakage (urinary incontinence) is common among people living in care homes. Most people wear absorbent pads to contain urine leakage, but this does not treat the cause of incontinence. Transcutaneous posterior tibial nerve stimulation is a treatment for the type of incontinence associated with a sudden need to use the toilet (urgency incontinence). Two sticky patches applied to the ankle are connected to a small electrical stimulator. The ELECTRIC (ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes) trial looked at whether or not transcutaneous posterior tibial nerve stimulation can help reduce incontinence for people in care homes. A total of 406 residents from 37 care homes were given transcutaneous posterior tibial nerve stimulation treatment or a dummy treatment for 30 minutes, twice per week for 6 weeks. The amount of urine leaked by each resident was measured over 24 hours by collecting all pads used in a sealable plastic bag and weighing the bag. This happened after the final transcutaneous posterior tibial nerve stimulation or dummy treatment, and again after 3 and 5 months. Residents, family members and care home staff were asked if they thought that the transcutaneous posterior tibial nerve stimulation had any effect and for their views of the treatment. We found no important difference in leakage between residents who had the transcutaneous posterior tibial nerve stimulation and those who had the dummy treatment. There were also no differences in daily pad use, feelings about bladder condition or quality of life. It cost around £120 to train staff to deliver transcutaneous posterior tibial nerve stimulation and around £80 per person to have transcutaneous posterior tibial nerve stimulation treatment. Transcutaneous posterior tibial nerve stimulation had no serious side-effects. Care home residents, even those with severe dementia, found the application of transcutaneous posterior tibial nerve stimulation acceptable. Staff found learning about incontinence helpful, but continence care routines did not change. In summary, the ELECTRIC trial found that for very dependent older people in care homes, transcutaneous posterior tibial nerve stimulation did not reduce urinary incontinence. The findings do not support transcutaneous posterior tibial nerve stimulation use to reduce urinary incontinence in care home environments.

Public values and plurality in health priority setting: What to do when people disagree and why we should care about reasons as well as choices.

CONTEXT: 'What does 'The Public' think?' is a question often posed by researchers and policy makers, and public values are regularly invoked to justify policy decisions. Over time there has been a participatory turn in the social and health sciences, including health technology assessment and priority setting in health, towards citizen participation such that public policies reflect public values. It is one thing to agree that public values are important, however, and another to agree on how public values should be elicited, deliberated upon and integrated into decision-making. Surveys of public values rarely deliver unanimity, and preference heterogeneity, or plurality, is to be expected. METHODS: This paper examines the role of public values in health policy and how to elicit, analyse, and present values, in the face of plurality. We delineate the strengths and weaknesses of aggregative and deliberative methods before setting out a new empirical framework, drawing on Sunstein's Incompletely Theorised Agreements, based on three levels: principles, policies and patients. The framework is illustrated using a recognised policy dilemma - the provision of high cost, limited-effect medicines intended to extend life for people with terminal illnesses. FINDINGS: Application of the multi-level framework to public values permits transparent consideration of plurality, including analysis of coherence and consensus, in a way that offers routes to policy recommendations that are based on public values and justified in those terms. CONCLUSIONS: Using the new framework and eliciting quantitative and qualitative data across levels of abstraction has the potential to inform policy recommendations grounded in public values, where values are plural. This is not to suggest that one solution will magically emerge, but rather that choices between policies can be explicitly justified in relation to the properties of public values, and a much clearer understanding of (in)consistencies and areas of consensus.

Men's sheds as an alternative healthcare route? A qualitative study of the impact of Men's sheds on user's health improvement behaviours.

BACKGROUND: Men's health is a globally underrepresented area of research and policy. With men facing numerous healthcare barriers, there are calls for more 'male friendly' approaches to health improvement that take into consideration differing male behaviours and attitudes towards health. Men's Sheds are community-based organisations delivering practical and social activities that encourage positive health behaviours. While Sheds have been recognised for their health and wellbeing benefits to men, research has yet to explore the impacts of Sheds on male health improvement and their potential role as a preventative gendered public health measure. METHODS: The study used in-depth interviews with 62 Shed members from five Sheds to investigate the impacts of Shed activity on the health improvement behaviours and attitudes of Shed users. Findings from the qualitative study were used to propose a set of pathways in which Sheds activity led to positive health engagement. RESULTS: The proposed pathways suggest that there are many different and interlinked ways in which Shed activities can impact on the health behaviours and attitudes of Shed users. Through participation in various practical and social activities in an inclusive environment, Shed users reported increases in their health seeking behaviours, improved perspectives on and management of their personal health, and an increased ability to overcome illness and recover. CONCLUSIONS: Where male friendly health provision has been lacking, this study suggests how Men's Shed activities can provide positive male health outcomes, often in unexpected and non-obvious ways. In particular, the proposed visual pathways are important to inform policymakers and practitioners of the ways in that Sheds may contribute to engaging men in health improvement practices and increase their health knowledge. This study also provides a structure from which further studies can measure and evaluate Shed health impacts.