Standardising outcome reporting for clinical trials of interventions for heavy menstrual bleeding: Development of a core outcome set.

OBJECTIVE: To develop a core outcome set for heavy menstrual bleeding (HMB). DESIGN: Core outcome set (COS) development methodology described by the COMET initiative. SETTING: University hospital gynaecology department, online international survey and web-based international consensus meetings. POPULATION OR SAMPLE: An international collaboration of stakeholders (clinicians, patients, academics, guideline developers) from 20 countries and 6 continents. METHODS: Phase 1: Systematic review of previously reported outcomes to identify potential core outcomes. Phase 2: Qualitative studies with patients to identify outcomes most important to them. Phase 3: Online two-round Delphi survey to achieve consensus about which outcomes are most important. Phase 4: A consensus meeting to finalise the COS. MAIN OUTCOME MEASURES: Outcome importance was assessed in the Delphi survey on a 9-point scale. RESULTS: From the 'long list' of 114, 10 outcomes were included in the final COS: subjective blood loss; flooding; menstrual cycle metrics; severity of dysmenorrhoea; number of days with dysmenorrhoea; quality of life; adverse events; patient satisfaction; number of patients going on to have further treatment for HMB and haemoglobin level. CONCLUSIONS: The final COS includes variables that are feasible for use in clinical trials in all resource settings and apply to all known underlying causes of the symptom of HMB. These outcomes should be reported in all future trials of interventions, their systematic reviews, and clinical guidelines to underpin policy.

Culturally tailored lifestyle interventions for the prevention and management of type 2 diabetes in adults of Black African ancestry: a systematic review of tailoring methods and their effectiveness.

OBJECTIVE: To evaluate the cultural tailoring methods used in type 2 diabetes (T2D), prevention and management interventions for populations of Black African ancestry and to examine their effectiveness on measures of glycaemia. DESIGN: Three databases were searched in October 2020; eligible studies used a randomised controlled trial (RCT) design to evaluate the effectiveness of culturally tailored lifestyle interventions compared with usual care for the prevention or management of T2D in adults of Black African ancestry. Cultural tailoring methods were evaluated using the Facilitator-Location-Language-Messaging (FiLLM) framework, whereby facilitator refers to delivery by individuals from the target community, language focuses on using native language or language appropriate to literacy levels, location refers to delivery in meaningful settings, and messaging is tailoring with relevant content and modes of delivery. RESULTS: Sixteen RCT were identified, all from USA. The mean age of participants was 55 years, majority female. Six of fifteen RCT reported significant improvements in glycated haemoglobin (HbA1c) at 6 and 8 months; one, in prediabetes, reported significantly improved fasting plasma glucose. Diabetes knowledge improvement (5/7 studies) was associated with HbA1c improvement. The majority tailored to location (12/16), facilitators (11/16), messaging (9/16) and language (6/16) domains of FiLLM. Those with ethnically matched facilitators and those which tailored to more than one domain showed the greatest HbA1C benefits. CONCLUSION: This evidence supports the effectiveness of culturally tailored lifestyle interventions for T2D management in populations of Black African ancestry, with further RCT needed to evaluate interventions for T2D prevention and for communities outside of the USA.

Development of Healthy Eating and Active Lifestyles for Diabetes, a culturally tailored diabetes self-management education and support programme for Black-British adults: A participatory research approach.

AIMS: To develop an evidence-based, culturally tailored, diabetes self-management education and support programme for Black-British adults, called Healthy Eating and Active Lifestyles for Diabetes (HEAL-D), using participatory methods to engage key stakeholders in the intervention design process. METHODS: Black-British adults living with type 2 diabetes, healthcare professionals and community leaders were engaged in an intervention development study. The intervention structure, format, content and delivery were developed through three phases of participatory research: Phase 1, formative research, involved focus groups and interviews; interactive co-development workshops were conducted in Phase 2; and Phase 3 focused on materials development. RESULTS: In Phase 1, focus groups and interviews identified the importance of nurturing collectivism, a reliance on informal sources of information/advice, barriers to attending appointments associated with competing priorities of work, travel and carer commitments, and a preference for directness and simple, clear advice/messages. A priority for healthcare professionals was the intervention embedding within current primary care structures and aligning with incentivised targets/metrics. Phase 2 (workshops) highlighted key requirements: avoidance of medical settings, appropriately trained and culturally knowledgeable educators, flexible appointments, preference for verbal and visual information and avoidance of technical/medical terminology. In Phase 3 (materials development), culturally sensitive videos, short films and information booklets were developed to convey educational messages, and food photography was used to provide culturally relevant dietary advice. CONCLUSIONS: Participatory methods provide a means to understand the needs of specific communities. This approach enables the development of healthcare interventions that are sensitive to the needs of service users and providers.

Strategies for living well with hormone-responsive advanced prostate cancer-a qualitative exploration.

PURPOSE: Due to recent treatment advances, men are increasingly living longer with advanced prostate cancer (PCa). This study sought to understand men's experiences of living with and adjusting to advanced hormone-responsive PCa and how this influenced their quality of life (QoL), in order to highlight how support could be optimized. METHODS: Participants were recruited through a UK wide survey-the 'Life After Prostate Cancer Diagnosis' study. In-depth telephone interviews were conducted with 24 men (aged 46-77 years) with advanced (stage IV) hormone-responsive PCa diagnosed 18-42 months previously. Thematic analysis was undertaken using a framework approach. RESULTS: Most participants perceived their QoL to be relatively good, which was influenced by the following factors (enablers to 'living well' with PCa): a sense of connectedness to others, engagement in meaningful activities, resources (social, cognitive, financial), ability to manage uncertainty, utilization of adjustment strategies and support, communication and information from health professionals. Barriers to 'living well' with PCa were often the converse of these factors. These also included more troublesome PCa-related symptoms and stronger perceptions of loss and restriction. CONCLUSIONS: In our study, men living with advanced hormone-responsive PCa often reported a good QoL. Exploring the influences on QoL in men with advanced PCa indicates how future interventions might improve the QoL of men who are struggling. Further research is required to develop and test interventions that enhance QoL for these men.

Adjustment strategies amongst black African and black Caribbean men following treatment for prostate cancer: Findings from the Life After Prostate Cancer Diagnosis (LAPCD) study.

OBJECTIVE: To explore adjustment strategies adopted by Black African (BA) and Black Caribbean (BC) men in the UK as a response to the impact of PCa diagnosis and treatment effects. METHODS: Men were recruited through the UK-wide 'Life After Prostate Cancer Diagnosis' (LAPCD) survey. Telephone interviews were conducted with men (n = 14) with BA and BC backgrounds between 18 and 42 months post-diagnosis. Data were analysed using a Framework approach. RESULTS: Most men (n = 12) were born outside the UK, were married (n = 9) and employed (n = 9). Median age was 66 years (range: 55-85). Six overarching themes emerged: a strong reliance upon faith beliefs; maintaining a 'positive' front; work as distraction; non-disclosure of diagnosis even amongst family members, influenced by stigma and masculinity concerns; active awareness-raising amongst a minority and support-seeking from close community. A few men emphasised a need to 'pitch' awareness-raising messages appropriately. Potential links existed between faith beliefs, presenting a positive front, community support-seeking and local awareness-raising. CONCLUSION: The provision of patient-centred care requires cultural sensitivity. Interventions that challenge stigma and men's reluctance to disclose problems associated with PCa and treatment may encourage help-seeking for symptom support. Research is needed to determine how best awareness-raising messages should be conveyed to black men.

A proof-of-concept framework for the preference elicitation and evaluation of health informatics technologies: the online PRESENT patient experience dashboard as a case example.

BACKGROUND: Constrained budgets within healthcare systems and the need to efficiently allocate resources often necessitate the valuation of healthcare interventions and services. However, when a technological product is developed for which no market exists it is a challenge to understand how to place the product and which specifications are the most sought after and important for end users. This was the case for a dashboard we developed, displaying analyses of patient experience survey free-text comments. METHOD: We describe a customisation and evaluation process for our online dashboard that addresses this challenge, using a Discrete Choice Experiment (DCE). We were not interested in the exact content of the dashboard, which was determined in previous stages of our larger study, but on the availability of features and customization options and how they affect individuals' purchasing behaviours. RESULTS: Our DCE completion rate was 33/152 (22%). Certain features were highly desirable - the search function, filtering, and upload own data - and would contribute significant added value to the dashboard. Purchasing behaviour was dependent on the dashboard features, going from a 10 to 90% probability to purchase when we moved from a baseline to a fully-featured dashboard. The purchasing behaviour elicited in this study assumes individuals already have buy-in to the online dashboard, so we assessed only how the various features of our dashboard influence the probability of purchasing the product. Results were used to inform development of a generic checklist of desirable healthcare dashboard features as well as to refine the dashboard itself. Our study suggests the development of the online dashboard and its roll-out in the market would result in a positive net benefit in terms of utilities. The cost-benefit analysis offers a lower bound estimate of the net benefit as it does not acknowledge or incorporate non-monetary benefits that would result from the use of the online dashboard, such as from improved healthcare management. CONCLUSION: DCEs can be successfully used to inform development of an online dashboard by determining preferences for particular features and customisation options and how this affects individuals' purchasing behaviours. The process should be transferable to the development of other technologies.

How do parole board members in England and Wales construct decisions about whether to release perpetrators of intimate partner violence from prison?

BACKGROUND: Existing research explores Parole Board decision-making, but not specifically for perpetrators of intimate partner violence (IPV), a special case due to the gendered and secretive nature of IPV and the role of control in predicting reoffending. AIM: To identify associations between case variables in England and Wales Parole Board decisions regarding perpetrators of IPV and explore how these variables help construct the decision. METHODS: Logistic regressions regarding decisions in a sample of all 137 male prisoners who had abused women and applied for release or progression to open conditions in England and Wales from April 2018 to September 2019, developed into latent class analyses. Thematic analyses of six interviews with Parole Board members about decision-making in IPV cases. RESULTS: Release decisions were strongly predicted by the recommendations of offender managers, offender supervisors and psychologists, mediated by the Parole Board's confidence in their ability. Decisions were also significantly associated with custodial behaviour and attendance on courses, mediated by the Board's confidence in the prisoner's insight and honesty. Thematic analysis was both consistent with these findings and provided a context in which the associations could be understood. CONCLUSIONS: The findings have implications for understanding the dynamics between professional decisions and the Parole Board's decision; for the importance of offender managers demonstrating their expertise and ability to manage risk; for Parole Board members' reflection and development; for academic research into IPV; and for those who have experienced IPV and are looking to understand parole decisions about their abuser.

The psychological impact of being on a monitoring pathway for localised prostate cancer: A UK-wide mixed methods study.

OBJECTIVE: To address concerns over the psychological impact of being on a monitoring pathway following prostate cancer (PCa) diagnosis, this study compared the psychological status of men on active surveillance (AS) or watchful waiting (WW) with men on active treatment (AT) and explored psychological adjustment in men on AS/WW. METHODS: Cross-sectional survey of UK men diagnosed with PCa 18 to 42 months previously (n = 16 726, localised disease at diagnosis) and telephone interviews with 24 men on AS/WW. Psychological outcomes were measured using two validated scales (Short Warwick-Edinburgh Mental Well-being Scale [SWEMWBS] and Kessler Psychological Distress Scale). Univariable and multivariable analyses compared outcomes between men on AS/WW and AT. Thematic analysis of interviews was undertaken, informed by a previously developed theory of adjustment to cancer. RESULTS: A total of 3986 (23.8%) respondents were on AS/WW. Overall, psychological outcomes were similar or better in men on AS/WW compared with those receiving AT (SWEMWBS: Poor well-being; 12.3% AS/WW vs 13.9% AT, adjusted OR = 0.86, 95% CI, 0.76-0.97; K6: severe psychological distress; 4.6% vs 5.4%, adjusted OR = 0.90, 95% CI, 0.74-1.08). Interviews indicated that most men on AS/WW had adjusted positively. Men with poorer well-being were less able to accept, reframe positively and normalise their diagnosis, described receiving insufficient information and support, and reported a lack of confidence in their health care professionals. CONCLUSIONS: Most men on AS/WW cope well psychologically. Men making treatment decisions should be given this information. Psychological health should be assessed to determine suitability for AS/WW, and at monitoring appointments. A clear action plan and support from health care professionals is important.

A realist review of which advocacy interventions work for which abused women under what circumstances.

BACKGROUND: Intimate partner abuse (including coercive control, physical, sexual, economic, emotional and economic abuse) is common worldwide. Advocacy may help women who are in, or have left, an abusive intimate relationship, to stop or reduce repeat victimisation and overcome consequences of the abuse. Advocacy primarily involves education, safety planning support and increasing access to different services. It may be stand-alone or part of other services and interventions, and may be provided within healthcare, criminal justice, social, government or specialist domestic violence services. We focus on the abuse of women, as interventions for abused men require different considerations. OBJECTIVES: To assess advocacy interventions for intimate partner abuse in women, in terms of which interventions work for whom, why and in what circumstances. SEARCH METHODS: In January 2019 we searched CENTRAL, MEDLINE, 12 other databases, two trials registers and two relevant websites. The search had three phases: scoping of articles to identify candidate theories; iterative recursive search for studies to explore and fill gaps in these theories; and systematic search for studies to test, confirm or refute our explanatory theory. SELECTION CRITERIA: Empirical studies of any advocacy or multi-component intervention including advocacy, intended for women aged 15 years and over who were experiencing or had experienced any form of intimate partner abuse, or of advocates delivering such interventions, or experiences of women who were receiving or had received such an intervention. Partner abuse encompasses coercive control in the absence of physical abuse. For theory development, we included studies that did not strictly fit our original criteria but provided information useful for theory development. DATA COLLECTION AND ANALYSIS: Four review authors independently extracted data, with double assessment of 10% of the data, and assessed risk of bias and quality of the evidence. We adopted RAMESES (Realist and meta-narrative evidence syntheses: evolving standards) standards for reporting results. We applied a realist approach to the analysis. MAIN RESULTS: We included 98 studies (147 articles). There were 88 core studies: 37 focused on advocates (4 survey-based, 3 instrument development, 30 qualitative focus) and seven on abused women (6 qualitative studies, 1 survey); 44 were experimental intervention studies (some including qualitative evaluations). Ten further studies (3 randomised controlled trials (RCTs), 1 intervention process evaluation, 1 qualitative study, 2 mixed methods studies, 2 surveys of women, and 1 mixed methods study of women and staff) did not fit the original criteria but added useful information, as befitting a realist approach. Two studies are awaiting classification and three are ongoing.Advocacy interventions varied considerably in contact hours, profession delivering and setting.We constructed a conceptual model from six essential principles based on context-mechanism-outcome (CMO) patterns.We have moderate and high confidence in evidence for the importance of considering both women's vulnerabilities and intersectionalities and the trade-offs of abuse-related decisions in the contexts of individual women's lives. Decisions should consider the risks to the woman's safety from the abuse. Whether actions resulting from advocacy increase or decrease abuse depends on contextual factors (e.g. severity and type of abuse), and the outcomes the particular advocacy intervention is designed to address (e.g. increasing successful court orders versus decreasing depression).We have low confidence in evidence regarding the significance of physical dependencies, being pregnant or having children. There were links between setting (high confidence), and potentially also theoretical underpinnings of interventions, type, duration and intensity of advocacy, advocate discipline and outcomes (moderate and low confidence). A good therapeutic alliance was important (high confidence); this alliance might be improved when advocates are matched with abused women on ethnicity or abuse experience, exercise cultural humility, and remove structural barriers to resource access by marginalised women. We identified significant challenges for advocates in inter-organisational working, vicarious traumatisation, and lack of clarity on how much support to give a woman (moderate and high confidence). To work effectively, advocates need ongoing training, role clarity, access to resources, and peer and institutional support.Our provisional model highlights the complex way that factors combine and interact for effective advocacy. We confirmed the core ingredients of advocacy according to both women and advocates, supported by studies and theoretical considerations: education and information on abuse; rights and resources; active referral and liaising with other services; risk assessment and safety planning. We were unable to confirm the impact of complexity of the intervention (low confidence). Our low confidence in the evidence was driven mostly by a lack of relevant studies, rather than poor-quality studies, despite the size of the review. AUTHORS' CONCLUSIONS: Results confirm the core ingredients of advocacy and suggest its use rests on sound theoretical underpinnings. We determined the elements of a good therapeutic alliance and how it might be improved, with a need for particular considerations of the factors affecting marginalised women. Women's goals from advocacy should be considered in the contexts of their personal lives. Women's safety was not necessarily at greatest risk from staying with the abuser. Potentially, if undertaken for long enough, advocacy should benefit an abused woman in terms of at least one outcome providing the goals are matched to each woman's needs. Some outcomes may take months to be determined. Where abuse is severe, some interventions may increase abuse. Advocates have a challenging role and must be supported emotionally, through provision of resources and through professional training, by organisations and peers.Future research should consider the different principles identified in this review, and study outcomes should be considered in relation to the mechanisms and contexts elucidated. More longitudinal evidence is needed. Single-subject research designs may help determine exactly when effect no longer increases, to determine the duration of longitudinal work, which will likely differ for vulnerable and marginalised women. Further work is needed to ascertain how to tailor advocacy interventions to cultural variations and rural and resource-poor settings. The methods used in the included studies may, in some cases, limit the applicability and completeness of the data reported. Economic analyses are required to ascertain if resources devoted to advocacy interventions are cost-effective in healthcare and community settings.

Community pharmacy interventions for health promotion: effects on professional practice and health outcomes.

BACKGROUND: Community pharmacies are an easily accessible and cost-effective platform for delivering health care worldwide, and the range of services provided has undergone rapid expansion in recent years. Thus, in addition to dispensing medication, pharmacy workers within community pharmacies now give advice on a range of health-promoting behaviours that aim to improve health and to optimise the management of long-term conditions. However, it remains uncertain whether these health-promotion interventions can change the professional practice of pharmacy workers, improve health behaviours and outcomes for pharmacy users and have the potential to address health inequalities. OBJECTIVES: To assess the effectiveness and safety of health-promotion interventions to change community pharmacy workers' professional practice and improve outcomes for users of community pharmacies. SEARCH METHODS: We searched MEDLINE, Embase, CENTRAL, six other databases and two trials registers to 6 February 2018. We also conducted reference checking, citation searches and contacted study authors to identify any additional studies. SELECTION CRITERIA: We included randomised trials of health-promotion interventions in community pharmacies targeted at, or delivered by, pharmacy workers that aimed to improve the health-related behaviour of people attending the pharmacy compared to no treatment, or usual treatment received in the community pharmacy. We excluded interventions where there was no interaction between pharmacy workers and pharmacy users, and those that focused on medication use only. DATA COLLECTION AND ANALYSIS: We used standard procedures recommended by Cochrane and the Effective Practice and Organisation of Care review group for both data collection and analysis. We compared intervention to no intervention or to usual treatment using standardised mean differences (SMD) and 95% confidence intervals (95% CI) (higher scores represent better outcomes for pharmacy user health-related behaviour and quality of life, and lower scores represent better outcomes for clinical outcomes, costs and adverse events). Interpretation of effect sizes (SMD) was in line with Cochrane recommendations. MAIN RESULTS: We included 57 randomised trials with 16,220 participants, described in 83 reports. Forty-nine studies were conducted in high-income countries, and eight in middle-income countries. We found no studies that had been conducted in low-income countries. Most interventions were educational, or incorporated skills training. Interventions were directed at pharmacy workers (n = 8), pharmacy users (n = 13), or both (n = 36). The clinical areas most frequently studied were diabetes, hypertension, asthma, and modification of cardiovascular risk. Duration of follow-up of interventions was often unclear. Only five studies gave details about the theoretical basis for the intervention, and studies did not provide sufficient data to comment on health inequalities. The most common sources of bias were lack of protection against contamination - mainly in individually randomised studies - and inadequate blinding of participants. The certainty of the evidence for all outcomes was moderate. We downgraded the certainty because of the heterogeneity across studies and evidence of potential publication bias. Professional practice outcomes We conducted a narrative analysis for pharmacy worker behaviour due to high heterogeneity in the results. Health-promotion interventions probably improve pharmacy workers' behaviour (2944 participants; 9 studies; moderate-certainty evidence) when compared to no intervention. These studies typically assessed behaviour using a simulated patient (mystery shopper) methodology. Pharmacy user outcomes Health-promotion interventions probably lead to a slight improvement in health-related behaviours of pharmacy users when compared to usual treatment (SMD 0.43, 95% CI 0.14 to 0.72; I2 = 89%; 10 trials; 2138 participants; moderate-certainty evidence). These interventions probably also lead to a slight improvement in intermediate clinical outcomes, such as levels of cholesterol or glycated haemoglobin, for pharmacy users (SMD -0.43, 95% CI -0.65 to -0.21; I2 = 90%; 20 trials; 3971 participants; moderate-certainty evidence). We identified no studies that evaluated the impact of health-promotion interventions on event-based clinical outcomes, such as stroke or myocardial infarction, or the psychological well-being of pharmacy users. Health-promotion interventions probably lead to a slight improvement in quality of life for pharmacy users (SMD 0.29, 95% CI 0.08 to 0.50; I2= 82%; 10 trials, 2687 participants; moderate-certainty evidence). Adverse events No studies reported adverse events for either pharmacy workers or pharmacy users. Costs We found that health-promotion interventions are likely to be cost-effective, based on moderate-certainty evidence from five of seven studies that reported an economic evaluation. AUTHORS' CONCLUSIONS: Health-promotion interventions in the community pharmacy context probably improve pharmacy workers' behaviour and probably have a slight beneficial effect on health-related behaviour, intermediate clinical outcomes, and quality of life for pharmacy users. Such interventions are likely to be cost-effective and the effects are seen across a range of clinical conditions and health-related behaviours. Nevertheless the magnitude of the effects varies between conditions, and more effective interventions might be developed if greater consideration were given to the theoretical basis of the intervention and mechanisms for effecting behaviour change.

Designing the Healthy Eating and Active Lifestyles for Diabetes (HEAL-D) self-management and support programme for UK African and Caribbean communities: a culturally tailored, complex intervention under-pinned by behaviour change theory.

BACKGROUND: UK African and Caribbean (AfC) communities are disproportionately burdened by type 2 diabetes (T2D). Promoting healthy eating and physical activity through structured education is the cornerstone of T2D care, however cultural barriers may limit engagement in these communities. In addition, changes in lifestyle behaviour are shaped by normative influences within social groups and contextual factors need to be understood to facilitate healthful behaviour change. The Behaviour Change Wheel (BCW) and associated COM-B framework offer intervention designers a systematic approach to developing interventions. The aim of this study was to apply the BCW in the design of a culturally sensitive self-management support programme for T2D in UK AfC communities. METHODS: An intervention development study was conducted. Focus groups were held with 41 AfC patients with T2D to understand healthful weight-management, diet and physical activity behaviours. The COM-B framework and BCW were used to evaluate the qualitative data, identify appropriate behaviour change techniques and specify the intervention components. RESULTS: Participants were motivated to avoid diabetes-related consequences although did not always understand the negative impact of their current health behaviours on long-term diabetes outcomes. Barriers to healthful behaviour included gaps in knowledge related to diet, physical activity and weight management guidance. In addition, motivation and social opportunity barriers included an acceptance of larger body sizes, rejection of body mass index for weight guidance and cultural identity being strongly linked to consumption of traditional starches. There was a lack of social opportunity to perform moderate to vigorous physical activity, although walking and dance were culturally acceptable. The resulting Healthy Eating & Active Lifestyles for Diabetes (HEAL-D) intervention uses social support, social comparison, credible sources and demonstration as key behaviour change techniques. CONCLUSION: Use of COM-B and the BCW highlighted the need for an intervention to address motivational and social opportunity barriers to engaging in healthful behaviours, as well as addressing key gaps in knowledge. This framework facilitated the linkage of theoretical behaviour constructs with evidence-based behaviour change techniques, which will enable us to evaluate operationalisation of our chosen BCTs and their impact on behaviour change in a future feasibility study.

Urinary, bowel and sexual health in older men from Northern Ireland.

OBJECTIVES: To provide data on the prevalence of urinary, bowel and sexual dysfunction in Northern Ireland (NI), to act as a baseline for studies of prostate cancer outcomes and to aid service provision within the general population. SUBJECTS AND METHODS: A cross-sectional postal survey of 10 000 men aged ≥40 years in NI was conducted and age-matched to the distribution of men living with prostate cancer. The EuroQoL five Dimensions five Levels (EQ-5D-5L) and 26-item Expanded Prostate Cancer Composite (EPIC-26) instruments were used to enable comparisons with prostate cancer outcome studies. Whilst representative of the prostate cancer survivor population, the age-distribution of the sample differs from the general population, thus data were generalised to the NI population by excluding those aged 40-59 years and applying survey weights. Results are presented as proportions reporting problems along with mean composite scores, with differences by respondent characteristics assessed using chi-squared tests, analysis of variance, and multivariable log-linear regression. RESULTS: Amongst men aged ≥60 years, 32.8% reported sexual dysfunction, 9.3% urinary dysfunction, and 6.5% bowel dysfunction. In all, 38.1% reported at least one problem and 2.1% all three. Worse outcome was associated with increasing number of long-term conditions, low physical activity, and higher body mass index (BMI). Urinary incontinence, urinary irritation/obstruction, and sexual dysfunction increased with age; whilst urinary incontinence, bowel, and sexual dysfunction were more common among the unemployed. CONCLUSION: These data provide an insight into sensitive issues seldom reported by elderly men, which result in poor general health, but could be addressed given adequate service provision. The relationship between these problems, raised BMI and low physical activity offers the prospect of additional health gain by addressing public health issues such as obesity. The results provide essential contemporary population data against which outcomes for those living with prostate cancer can be compared. They will facilitate greater understanding of the true impact of specific treatments such as surgical interventions, pelvic radiation or androgen-deprivation therapy.

Prostate cancer and the impact on couples: a qualitative metasynthesis.

PURPOSE: To review and interpret existing qualitative literature on the experiences of couples affected by prostate cancer (PCa). METHODS: A metasynthesis was carried out which included a systematic search of seven databases between 2000 and 2016. A modified version of Noblit and Hare's meta-ethnographic approach was used to synthesise qualitative study findings and inform overarching interpretations. RESULTS: Thirty-seven studies focusing on the experiences of men with PCa and their partner dyad were included producing seven interconnected constructs. The construct accepting change vs seeking continuity reflects the range of ways individuals within the dyad and couples adjust to the diagnosis. Cultivating connection vs disengaging illustrates how couples seek to manage the impact of PCa and its treatment on their relationship, which may lead to a threatened identity, including sexual insecurities. Shielding me, you and us reflects the ways in which couples strive to protect themselves as individuals and/or each other from the impact of PCa. Being a partner and its challenges highlights the responsibilities partners assume and the impact of their supporting role. Yet, partners sometimes report feeling unsupported and side-lined both by the man they are caring for and by healthcare professionals. Couples often recognise the value of facing PCa together. CONCLUSIONS: PCa affects both members of the dyad as individuals, as well as the couple's relationship. How best to support couples and how to overcome difficulties in expressing their concerns to one another requires further consideration. Healthcare professionals should endeavour to employ a couple-focused approach where appropriate.

Ethnicity and the prostate cancer experience: a qualitative metasynthesis.

OBJECTIVES: To summarize black and minority ethnic (BME) patients' and partners experiences of prostate cancer by examining the findings of existing qualitative studies. METHODS: We undertook a systematic metasynthesis of qualitative studies using a modified version of Noblit and Hare's "meta-ethnography" approach, with a 2000-2015 search of 7 databases. RESULTS: Thirteen studies of men from US and UK BME groups were included. We explored constructs with BME-specific features. Health care provider relationships, formation of a spiritual alliance with God (which enhanced the participants' feeling of empowerment and ability to cope with the cancer), and living on for others (generally to increase cancer awareness), often connected to spiritual regrowth, were the 3 constructs most commonly reported. A magnified effect from erectile dysfunction was also common. Initially, this affected men's disclosure to others about their cancer and their sexual problems, but eventually men responded by shifting their conceptualizations of masculinity to sustain self and social identities. There was also evidence of inequality resulting from financial constraints and adversity that necessitated resilience in coping. CONCLUSIONS: The prostate cancer experience of BME men and their partners is affected by a complex intersection of ethnicity with other factors. Health care services should acknowledge this. If providers recognize the men's felt masculinities, social identities, and spiritual beliefs and their shifting nature, services could be improved, with community as well as individual benefits. More studies are needed in diverse ethnic groups.

Advocacy interventions to reduce or eliminate violence and promote the physical and psychosocial well-being of women who experience intimate partner abuse.

BACKGROUND: Intimate partner abuse is common worldwide, damaging the short- and long-term physical, mental, and emotional health of survivors and children. Advocacy may contribute to reducing abuse, empowering women to improve their situation by providing informal counselling and support for safety planning and increasing access to different services. Advocacy may be a stand-alone service, accepting referrals from healthcare providers, or part of a multi-component (and possibly multi-agency) intervention provided by service staff or others. OBJECTIVES: To assess the effects of advocacy interventions within or outside healthcare settings in women who have experienced intimate partner abuse. SEARCH METHODS: In April 2015, we searched CENTRAL, Ovid MEDLINE, EMBASE, and 10 other databases. We also searched WHO ICTRP, mRCT, and UK Clinical Research Network (UKCRN), and examined relevant websites and reference lists with forward citation tracking of included studies. For the original review we handsearched six key journals. We also contacted first authors of eligible papers and experts in the field. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials comparing advocacy interventions for women with experience of intimate partner abuse versus no intervention or usual care (if advocacy was minimal and fewer than 20% of women received it). DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias and undertook data extraction. We contacted authors for missing information needed to calculate statistics for the review and looked for adverse events. MAIN RESULTS: We included 13 trials involving 2141 participants aged 15 to 65 years, frequently having low socioeconomic status.The studies were quite heterogeneous in terms of methodology, study processes and design, including with regard to the duration of follow-up (postintervention to three years), although this was not associated with differences in effect. The studies also had considerable clinical heterogeneity in relation to staff delivering advocacy; setting (community, shelter, antenatal, healthcare); advocacy intensity (from 30 minutes to 80 hours); and abuse severity. Three trials evaluated advocacy within multi-component interventions. Eleven measured some form of abuse (eight scales), six assessed quality of life (three scales), and six measured depression (three scales). Countries and ethnic groups varied (one or more minority ethnic groups in the USA or UK, and local populations in Hong Kong and Peru). Setting was associated with intensity and duration of advocacy.Risk of bias was high in five studies, moderate in five, and low in three. The quality of evidence (considering multiple factors such as risk of bias, study size, missing data) was moderate to low for brief advocacy and very low for intensive advocacy. Incidence of abuse Physical abuseModerate quality pooled data from two healthcare studies (moderate risk of bias) and one community study (low risk of bias), all with 12-month follow-up data, showed no effect on physical abuse for brief (< 12 hours) advocacy interventions (standardised mean difference (SMD) 0.00, 95% confidence interval (CI) - 0.17 to 0.16; n = 558). One antenatal study (low risk of bias) showed an association between brief advocacy and reduced minor physical abuse at one year (mean difference (MD) change - 1.00, 95% CI - 1.82 to - 0.18; n = 110). An antenatal, multi-component study showed a greater likelihood of physical abuse ending (odds ratio (OR) 0.42, 95% CI 0.23 to 0.75) immediately after advocacy (number needed to treat (NNT) = 8); we cannot exclude impact from other components.Low to very low quality evidence from two intensive advocacy trials (12 hours plus duration) showed reduced severe physical abuse in women leaving a shelter at 24 months (OR 0.39, 95% CI 0.20 to 0.77; NNT = 8), but not at 12 or 36 months. Sexual abuseMeta-analysis of two studies (n = 239) showed no effect of advocacy on sexual abuse (SMD - 0.12, 95% CI - 0.37 to 0.14), agreeing with the change score (MD - 0.07, 95% CI - 0.30 to 0.16) from a third study and the OR (0.96, 95% CI 0.44 to 2.12) from a fourth antenatal, multi-component study. Emotional abuseOne study in antenatal care, rated at low risk of bias, showed reduced emotional abuse at ≤ 12-month follow-up (MD (change score) - 4.24, 95% CI - 6.42 to - 2.06; n = 110). Psychosocial health Quality of lifeMeta-analysis of two studies (high risk of bias) showed intensive advocacy slightly improved overall quality of life of women recruited from shelters (MD 0.23, 95% CI 0.00 to 0.46; n = 343) at 12-month follow-up, with greater improvement in perceived physical quality of life from a primary care study (high risk of bias; MD 4.90, 95% CI 0.98 to 8.82) immediately postintervention. Depression Meta-analysis of two studies in healthcare settings, one at high risk of bias and one at moderate risk, showed that fewer women developed depression (OR 0.31, 95% CI 0.15 to 0.65; n = 149; NNT = 4) with brief advocacy. One study at high risk of bias reported a slight reduction in depression in pregnant women immediately after the intervention (OR 0.51, 95% CI 0.20 to 1.29; n = 103; NNT = 8).There was no evidence that intensive advocacy reduced depression at ≤ 12-month follow-up (MD - 0.14, 95% CI - 0.33 to 0.05; 3 studies; n = 446) or at two years (SMD - 0.12, 95% CI - 0.36 to 0.12; 1 study; n = 265). Adverse effectsTwo women died, one who was murdered by her partner and one who committed suicide. No evidence links either death to study participation. AUTHORS' CONCLUSIONS: Results suggest some benefits from advocacy. However, most studies were underpowered. Clinical and methodological heterogeneity largely precluded pooling of trials. Therefore, there is uncertainty about the magnitude of benefit, the impact of abuse severity, and the setting.Based on the evidence reviewed, intensive advocacy may improve short-term quality of life and reduce physical abuse one to two years after the intervention for women recruited from domestic violence shelters or refuges. Brief advocacy may provide small short-term mental health benefits and reduce abuse, particularly in pregnant women and for less severe abuse.

Multiple sclerosis outpatient future groups: improving the quality of participant interaction and ideation tools within service improvement activities.

BACKGROUND: Improving the patient experience is a key focus within the National Health Service. This has led us to consider how health services are experienced, from both staff and patient perspectives. Novel service improvement activities bring staff and patients together to use design-led methods to improve how health services are delivered. The Multiple Sclerosis Outpatient Future Group study aimed to explore how analogies and props can be used to facilitate rich interactions between staff and patients within these activities. This paper will consider how these interactions supported participants to share experiences, generate ideas and suggest service improvements. METHOD: Qualitative explorative study using 'future groups,' a reinterpretation of the recognised focus groups method directed towards exploring future alternatives through employing analogies and physical props to engage participants to speculate about future service interactions and health experiences. Participants were people with multiple sclerosis (PwMS) and outpatient staff: staff nurses, nursing assistants, junior sisters and reception staff. RESULTS: Use of future groups, analogies and physical props enabled PwMS and outpatient staff to invest their own ideas and feelings in the service improvement activity and envisage alternative health care scenarios. The combination of participants in the groups with their diverse perspectives and knowledge of the service led to a collaborative approach in which staff highlighted potential practical problems and patients ensured ideas were holistic. Service improvements were prototyped and tested in the outpatient clinic. CONCLUSION: Design-led methods such as future groups using analogies and physical props can be used to facilitate interactions between staff and patients in service improvement activities, leading to the generation of meaningful ideas. It is hoped that improving the quality of ideation tools within design-led methods can contribute to developing successful service interventions in service improvement activities.

Unmasking quality: exploring meanings of health by doing art.

BACKGROUND: Quality in healthcare has many potential meanings and interpretations. The case has been made for conceptualisations of quality that place more emphasis on describing quality and less on measuring it through structured, vertically oriented metrics. Through discussion of an interdisciplinary community arts project we explore and challenge the dominant reductionist meanings of quality in healthcare. DISCUSSION: The model for structured participatory arts workshops such as ours is 'art as conversation'. In creating textile art works, women involved in the sewing workshops engaged at a personal level, developing confidence through sharing ideas, experiences and humour. Group discussions built on the self-assurance gained from doing craft work together and talking in a relaxed way with a common purpose, exploring the health themes which were the focus of the art. For example, working on a textile about vitamin D created a framework which stimulated the emergence of a common discourse about different cultural practices around 'going out in the sun'. These conversations have value as 'bridging work', between the culture of medicine, with its current emphasis on lifestyle change to prevent illness, and patients' life worlds. Such bridges allow for innovation and flexibility to reflect local public health needs and community concerns. They also enable us to view care from a horizontally oriented perspective, so that the interface in which social worlds and the biomedical model meet and interpenetrate is made visible. Through this interdisciplinary art project involving academics, health professionals and the local community we have become more sensitised to conceptualising one aspect of health care quality as ensuring a 'space for the story' in health care encounters. This space gives precedence to the patient narratives, but acknowledges the importance of enabling clinicians to have time to share stories about care.

Social support and mental well-being among people with and without chronic illness during the Covid-19 pandemic: evidence from the longitudinal UCL covid survey.

PURPOSE: An immediate research priority recovering from the COVID-19 pandemic is well-being among some of our most vulnerable-people with chronic illness. We studied how mental health changed among people with and without chronic illness throughout the pandemic and the mediating role of social support. METHODS: We used the 3-waves of COVID-19 survey within the Millennium Cohort Study (MCS, age 19, N = 5522) and MCS Parent (MCSP, age > > 19, N = 7479) samples, with additional pre-pandemic measures of some outcomes and exposure. Using Structural Equation Panel Models with Full Information Maximum Likelihood estimation to address missing data, we studied differences between respondents with a chronic illness and without, regarding depressive symptoms and mental well-being, with social provision, social support, and loneliness as potential mediators. RESULTS: Mental well-being (SWEMWBS) and psychological distress (Kessler-6) worsened significantly during the pandemic relative to baseline for people with and without chronic illness, while the latter group had substantially better well-being at all waves and the baseline regarding both outcomes. When the lockdown was lifted during wave-2, mental well-being temporarily rebounded, and distress waned among people without chronic illness but continued to worsen among people with chronic illness. Social support partially mediated the link between chronic illness and mental well-being. CONCLUSIONS: The large mental well-being gap between people with and without chronic illness persisted during the pandemic. However, social support and provision can partially narrow this gap, hence should be employed in future pandemic management.

Training Informal Supporters to Improve Responses to Victim-Survivors of Domestic Violence and Abuse: A Systematic Review.

Informal supporters (friends, family, colleagues, and community members) play a crucial role in societal-wide responses to victim-survivors of domestic violence and abuse. Familial and social networks, however, report a sense of helplessness and difficulties in knowing how to respond. This mixed method systematic review examines the effectiveness, and perceived effectiveness, of training informal supporters to improve their responses to victim-survivors. A novel conceptual framework was developed to underpin the review. A systematic search of four electronic databases, specialist repositories, and websites were used to identify empirical research (in academic or gray literature). Eleven included studies examined educational interventions that aimed to improve responses from informal supporters. Quality appraisal was undertaken, and studies were judged to be "good enough" for synthesis. The studies in the review indicated that informal supporters recognized the value of training for building understanding and equipping them with the skills to respond to victim-survivors. The synthesis identified statistically significant improvements in the knowledge and attitudes of informal supporters in the immediate and short-term following training. Using a behavior change model to frame the evidence, the review found that training/educational activities prime informal supporters to respond to victim-survivors, as well as enhancing their capacity and motivation to do so. This increases the likelihood that informal supporters will take action to support victim-survivors of abuse. We don't know, however, what type of support they will provide and/or whether it would be judged to be helpful by victim-survivors.

Ethically Driven and Methodologically Tailored: Setting the Agenda for Systematic Reviews in Domestic Violence and Abuse.

Purpose: Systematic reviews have an important, and growing, role to play in the global evidence eco-system of domestic violence and abuse. Alongside substantive contributions to knowledge, such reviews stimulate debates about ethical reviewing practices and the importance of tailoring methods to the nuances of the field. This paper aims to pinpoint a set of ethical and methodological priorities to guide and enhance review practices specifically in the field of domestic abuse. Method: The five Pillars of the Research Integrity Framework (ethical guidelines for domestic abuse research) are used to interrogate the systematic review process. To do so, the Framework is retrospectively applied to a recently completed systematic review in domestic abuse. The review included a rapid systematic map and in-depth analysis of interventions aimed at creating or enhancing informal support and social networks for victim-survivors of abuse. Results: Ethical and methodological priorities for systematic reviews in domestic abuse include (1) Safety and wellbeing: maintaining the wellbeing of researchers and stakeholders, and appraising the ethics of included studies, (2) Transparency/ accountability: transparent reporting of research funding, aims and methods together with explicit consideration of authorship of outputs, (3) Equality, human rights and social justice: developing diverse review teams/ Advisory groups, and review methods that aim to search for, and report, diverse perspectives. Considering researcher positionality/ reflexivity in the review, (4) Engagement: collaboration with non-academic stakeholders and individuals with lived experience throughout the review process, (5) Research Ethics: independent ethical scrutiny of systematic review proposals with input from researchers with expertise in systematic reviews and domestic abuse. Conclusion: Additional research is required to comprehensively examine the ethics of each stage of the review process. In the meantime, attention should be given to the underpinning ethical framework for our systematic review practices and the wider research infrastructure that governs reviews.