Protocol for the feasibility and implementation study of a model of best practice in primary care led postdiagnostic dementia care: PriDem.

INTRODUCTION: Care is often inadequate and poorly integrated after a dementia diagnosis. Research and policy highlight the unaffordability and unsustainability of specialist-led support, and instead suggest a task-shared model, led by primary care. This study is part of the PriDem primary care led postdiagnostic dementia care research programme and will assess delivery of an evidence-informed, primary care based, person-centred intervention. The intervention involves Clinical Dementia Leads (CDLs) working in primary care to develop effective dementia care systems that build workforce capacity and support teams to deliver tailored support to people living with dementia and their carers. METHODS AND ANALYSIS: This is a 15-month mixed-methods feasibility and implementation study, situated in four National Health Service (NHS) primary care networks in England. The primary outcome is adoption of personalised care planning by participating general practices, assessed through a patient records audit. Feasibility outcomes include recruitment and retention; appropriateness and acceptability of outcome measures; acceptability, feasibility and fidelity of intervention components. People living with dementia (n=80) and carers (n=66) will be recruited through participating general practices and will complete standardised measures of health and well-being. Participant service use data will be extracted from electronic medical records. A process evaluation will explore implementation barriers and facilitators through methods including semistructured interviews with people living with dementia, carers and professionals; observation of CDL engagement with practice staff; and a practice fidelity log. Process evaluation data will be analysed qualitatively using codebook thematic analysis, and quantitatively using descriptive statistics. Economic analysis will determine intervention cost-effectiveness. ETHICS AND DISSEMINATION: The study has received favourable ethical opinion from Wales REC4. NHS Confidentiality Advisory Group support allows researchers preconsent access to patient data. Results will inform intervention adaptations and a future large-scale evaluation. Dissemination through peer-review journals, engagement with policy-makers and conferences will inform recommendations for dementia services commissioning. TRIAL REGISTRATION NUMBER: ISRCTN11677384.

Time trends in contraceptive prescribing in UK primary care 2000-2018: a repeated cross-sectional study.

BACKGROUND: Over the last 20 years, new contraceptive methods became available and incentives to increase contraceptive uptake were introduced. We aimed to describe temporal trends in non-barrier contraceptive prescribing in UK primary care for the period 2000-2018. METHODS: A repeated cross-sectional study using patient data from the IQVIA Medical Research Data (IMRD) database. The proportion (95% CI) of women prescribed non-barrier contraception per year was captured. RESULTS: A total of 2 705 638 women aged 15-49 years were included. Between 2000 and 2018, the proportion of women prescribed combined hormonal contraception (CHC) fell from 26.2% (26.0%-26.3%) to 14.3% (14.2%-14.3%). Prescriptions for progestogen-only pills (POPs) and long-acting reversible contraception (LARC) rose from 4.3% (4.3%-4.4%) to 10.8% (10.7%-10.9%) and 4.2% (4.1%-4.2%) to 6.5% (6.5%-6.6%), respectively. Comparing 2018 data for most deprived versus least deprived areas, women from the most deprived areas were more likely to be prescribed LARC (7.7% (7.5%-7.9%) vs 5.6% (5.4%-5.8%)) while women from the least deprived areas were more likely to be prescribed contraceptive pills (20.8% (21.1%-21.5%) vs 26.2% (26.5%-26.9%)). In 2009, LARC prescriptions increased irrespective of age and social deprivation in line with a pay-for-performance incentive. However, following the incentive's withdrawal in 2014, LARC prescriptions for adolescents aged 15-19 years fell from 6.8% (6.6%-7.0%) in 2013 to 5.6% (5.4%-5.8%) in 2018. CONCLUSIONS: CHC prescribing fell by 46% while POP prescribing more than doubled. The type of contraception prescribed was influenced by social deprivation. Withdrawal of a pay-for-performance incentive may have adversely affected adolescent LARC uptake, highlighting the need for further intervention to target this at-risk group.

Equity considerations in outcome measures of the HIV pre-exposure prophylaxis care continuum in high-income countries: a systematic review protocol.

INTRODUCTION: HIV pre-exposure prophylaxis (PrEP) is an effective intervention to reduce acquisition of HIV. PrEP provision has increased in recent years, however, it is not known whether PrEP implementation has been equitably implemented across all risk groups, particularly groups experiencing high levels of health inequity. A PrEP care continuum (PCC) has been proposed to evaluate the success of PrEP implementation programmes, but the extent to which health equity characteristics are currently taken into account in the PCC has not been described. The objectives of this proposed systematic review are to (i) identify and collate outcome measure definitions for the main stages of the PCC (awareness, acceptability, uptake, adherence and retention), (ii) describe how equity characteristics are considered in outcome definitions of the PCC and (iii) describe data sources for capturing equity characteristics. METHODS AND ANALYSIS: Quantitative studies published between 1 January 2012 and 3 March 2020 will be included. Five databases (MEDLINE, PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Applied Social Sciences Index and Abstracts) will be searched to identify English language publications that include an outcome measure definition of at least one of the five main stages of the PCC. Risk of bias will be assessed using the Effective Public Health Practice Project Quality Assessment Tool for Quantitative Studies. Data on outcome measure definitions and equity characteristics will be extracted. Results will be presented in a narrative synthesis and all findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. ETHICS AND DISSEMINATION: Ethical approval is not required. The results will be disseminated via submission for publication to a peer-reviewed journal when complete. The review findings will have relevance to healthcare professionals, policymakers and commissioners in informing how to best evaluate PrEP implementation programmes and inform new implementation strategies for vulnerable and less advantaged populations. PROSPERO REGISTRATION NUMBER: CRD42020169779.

Implementing post diagnostic dementia care in primary care: a mixed-methods systematic review.

OBJECTIVES: Concentrating post-diagnostic dementia care in primary care may lead to better and more cost-effective care closer to home. We aimed to assess which intervention components and contextual factors may contribute to the successful delivery and implementation of primary care-led post-diagnostic dementia care. METHODS: Mixed-methods systematic review. We searched five databases (inception-March 2019) with reference list screening and citation tracking. We included studies evaluating post-diagnostic dementia care interventions where primary care had a significant role in dementia care, which assessed one or more implementation elements (acceptability, feasibility, adoption, sustainability, reach, costs, appropriateness or fidelity). Two authors independently critically appraised studies. RESULTS: Out of 4528 unique references, we screened 380 full texts and included 49 evaluations of services collecting implementation process data. Most services had high acceptability ratings. The most acceptable components were information provision, social and emotional support and links to community organisations. Feasibility was chiefly influenced by provider engagement and leadership, building dementia care capacity, sufficient resources/funding and collaboration. Care quality was maximised through adding capacity from a dementia-specific health professional. On the basis of limited data, costs for various primary care-led models did not substantially differ from each other. CONCLUSION: A range of primary care-led dementia care models appear feasible and acceptable. Future services should: add dementia-focussed health professionals into primary care, develop primary care leadership and provide sufficient funding and collaboration opportunities. Information, community service links and social and ongoing support should be part of services. Further exploration of service reach and formalised fidelity assessment are needed.

Pilot cluster randomised trial of an evidence-based intervention to reduce avoidable hospital admissions in nursing home residents (Better Health in Residents of Care Homes with Nursing-BHiRCH-NH Study).

OBJECTIVES: To pilot a complex intervention to support healthcare and improve early detection and treatment for common health conditions experienced by nursing home (NH) residents. DESIGN: Pilot cluster randomised controlled trial. SETTING: 14 NHs (7 intervention, 7 control) in London and West Yorkshire. PARTICIPANTS: NH residents, their family carers and staff. INTERVENTION: Complex intervention to support healthcare and improve early detection and treatment of urinary tract and respiratory infections, chronic heart failure and dehydration, comprising: (1) 'Stop and Watch (S&W)' early warning tool for changes in physical health, (2) condition-specific care pathway and (3) Situation, Background, Assessment and Recommendation tool to enhance communication with primary care. Implementation was supported by Practice Development Champions, a Practice Development Support Group and regular telephone coaching with external facilitators. OUTCOME MEASURES: Data on NH (quality ratings, size, ownership), residents, family carers and staff demographics during the month prior to intervention and subsequently, numbers of admissions, accident and emergency visits, and unscheduled general practitioner visits monthly for 6 months during intervention. We collected data on how the intervention was used, healthcare resource use and quality of life data for economic evaluation. We assessed recruitment and retention, and whether a full trial was warranted. RESULTS: We recruited 14 NHs, 148 staff, 95 family carers and 245 residents. We retained the majority of participants recruited (95%). 15% of residents had an unplanned hospital admission for one of the four study conditions. We were able to collect sufficient questionnaire data (all over 96% complete). No NH implemented intervention tools as planned. Only 16 S&W forms and 8 care pathways were completed. There was no evidence of harm. CONCLUSIONS: Recruitment, retention and data collection processes were effective but the intervention not implemented. A full trial is not warranted. TRIAL REGISTRATION NUMBER: ISRCTN74109734 (https://doi.org/10.1186/ISRCTN74109734). ORIGINAL PROTOCOL: BMJ Open. 2019;9(5):e026510. doi:10.1136/bmjopen-2018-026510.

An interactive website to aid young women's choice of contraception: feasibility and efficacy RCT.

BACKGROUND: Effective use of contraception can reduce numbers of unintended pregnancies, but misunderstandings and concerns about contraception abound. Increasingly, women seek health-care information online. OBJECTIVES: To develop an interactive website to aid informed choice of contraceptive method, including long-acting reversible contraception (Phase I), and test its effectiveness in a parallel, single-blind randomised trial (Phase II). Approval came from London - Camden & King's Cross Research Ethics Committee (reference 17/LO/0112). SETTING AND PARTICIPANTS: For both phases, women aged 15-30 years were recruited from general practice, sexual health services, maternity services, community pharmacies and an abortion service. DESIGN: In Phase I, we conducted three systematic literature reviews, a review of YouTube (YouTube, LLC, San Bruno, CA, USA) videos about contraception, and focus groups and interviews with young women to explore barriers to and concerns and misperceptions about contraception. We then iteratively co-designed an interactive website, Contraception Choices [URL: www.contraceptionchoices.org (accessed June 2020)], with young women and a software company. In Phase II, we evaluated the website through a randomised trial that began as a feasibility trial. Early demand for Contraception Choices stimulated a design change from a feasibility to an efficacy trial, with follow-up for clinical outcomes at 3 and 6 months. A randomisation list was incorporated into the trial software program to allocate participants to the intervention (website) or control group (standard care). INTERVENTION: Contraception Choices is a co-designed, evidence-based, interactive website to aid informed choice of contraception. It provides information about different methods, addresses common concerns and offers tailored contraceptive options in response to individual preferences. MAIN OUTCOME MEASURES: Qualitative - participant views and experience of the intervention, assessed through qualitative interviews. Quantitative primary outcomes - follow-up rate at 6 months in the initial feasibility trial, using a long-acting reversible contraception method, and satisfaction with contraceptive method at 6 months in the efficacy trial. RESULTS: A total of 927 women were randomised online to the website (n = 464) or control group (n = 463), of whom 739 (80%) provided follow-up data at 6 months [786 women (85%) provided data at 3 and/or 6 months that were included in the analysis of primary outcomes]. There was little difference between groups in the proportion using long-acting reversible contraception at 6 months [30.4% intervention vs. 31.0% control, adjusted odds ratio after imputation 0.87 (95% confidence interval 0.60 to 1.27)] or in satisfaction with contraceptive method [proportion being 'satisfied' or 'very satisfied', 82.6% intervention vs. 82.1% control, adjusted odds ratio 0.93 (95% confidence interval 0.69 to 1.25)]. Qualitative evaluation indicated highly positive views about the website and increased knowledge of contraceptive methods that could dispel misperceptions. Women appreciated having information tailored to their specific needs and felt better prepared before consultations. LIMITATIONS: We did not include intermediate measures, such as knowledge of contraceptive methods, intention to change method or confidence in discussing contraception with a health-care professional, which may have indicated other benefits of using the website. In future, the website should be studied in different settings (e.g. schools and in routine practice) to see whether or not it improves the quality or efficiency of contraceptive consultations. CONCLUSIONS: Our systematic review indicated wide-ranging influences on women's use of contraception globally. The website, Contraception Choices, was very popular with young women and contraception service providers. It was not associated with statistically significant differences in use of long-acting reversible contraception or satisfaction with contraceptive method at 6 months. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13247829. 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. 24, No. 56. See the NIHR Journals Library website for further project information.

WHAT WAS THE QUESTION?: Choosing between types of contraception can be challenging, so can a website help women make the right choice for them? WHAT DID WE DO?: We asked women what they think about contraception. We looked at other studies and YouTube (YouTube, LLC, San Bruno, CA, USA) videos. We then designed the Contraception Choices website with young women [URL: www.contraceptionchoices.org (accessed January 2020)]. The website describes each type of contraception and compares them side by side. When users answer questions about what matters to them, the website suggests three types of contraception they might like. A total of 927 women helped us test the website in an online trial. We asked everyone what contraception they were using and how satisfied they were with it 6 months later. WHAT DID WE FIND?: Women really liked the website. Ninety-seven per cent of participants found it helpful or very helpful for 'getting useful information about contraception' and 87% responded that it was helpful or very helpful for 'finding a method of contraception that is right for you'. Comments included: However, seeing the website did not mean that women used a more reliable type of contraception. Women were just as satisfied with their contraception whether or not they had seen the website. We think that this is because many other factors are involved; for example, some women found it difficult to access long-acting contraception methods from health services. WHAT DOES THIS MEAN?: Young women liked the Contraception Choices website and found it useful. Women can be put off by contraception side effects and the views of partners, friends, family and others. On its own, the Contraception Choices website was not enough to help more women use the most reliable contraception methods.

What works in managing complex conditions in older people in primary and community care? A state-of-the-art review.

The number of older people living with complex health conditions is increasing, with the majority of these managed in primary and community settings. Many models of care have been developed to support them, however, there is mixed evidence on their value and they include multiple overlapping components. We aimed to synthesise the evidence to learn what works for managing complex conditions in older people in primary and community care. We carried out a state-of-the-art review of systematic reviews. We searched three databases (January 2009 to July 2019) for models of primary and community care for long-term conditions, frailty, multimorbidity and complex neurological conditions common to older people such as dementia. We narratively synthesised review findings to summarise the evidence for each model type and identify components which influenced effectiveness. Out of 2,129 unique titles and abstracts, 178 full texts were reviewed and 54 systematic reviews were included. We found that the models of care were more likely to improve depressive symptoms and mental health outcomes than physical health or service use outcomes. Interventions including self-management, patient education, assessment with follow-up care procedures, and structured care processes or pathways had greater evidence of effectiveness. The level of healthcare service integration appeared to be more important than inclusion of specific professional types within a team. However, more experienced and qualified nurses were associated with better outcomes. These conclusions are limited by the overlap between reviews, reliance on vote counting within some included reviews and the quality of study reports. In conclusion, primary and community care interventions for complex conditions in older people should include: (a) clear intervention targets; (b) explicit theoretical underpinnings; and (c) elements of self-management and patient education, structured collaboration between healthcare professionals and professional support. Further work needs to determine the optimal intensity, length, team composition and role of technology in interventions.

An interactive website for informed contraception choice: randomised evaluation of Contraception Choices.

OBJECTIVE: Improving use of effective contraception to prevent unintended pregnancy is a global priority, but misperceptions and concerns about contraception are common. Our objective was to evaluate an interactive website to aid informed choice of contraception. METHODS: The Contraception Choices website is an interactive digital intervention which offers tailored advice to aid contraception decision-making (www.contraceptionchoices.org). In a parallel single-blind trial, we randomised 927 women aged 15-30 years from six clinic settings to access the intervention website (n = 464) or to a waiting-list control group (n = 463). The study was initially a feasibility trial, evolving into an evaluation of efficacy, with two primary outcomes at six months: long-acting reversible contraception (LARC) use, and satisfaction with contraceptive method. Secondary outcomes included self-reported pregnancy and sexually transmitted infection diagnoses. Free-text comments on the 3 and 6 month outcome surveys were analysed thematically. FINDINGS: There was no significant difference between intervention and control groups in the proportion of women using LARC [30.4% intervention versus 31.0% control; adjusted odds ratio 0.87 (95% confidence interval 0.60 to 1.28)]; satisfaction with contraceptive method [82.6% versus 82.1%; adjusted ordinal odds ratio 0.93 (95% CI 0.69 to 1.25)]; self-reported pregnancy [3.3% versus 4.1%; adjusted odds ratio 0.90 (95% CI 0.45 to 1.79)] nor sexually transmitted infection [5.3% versus 4.7%; adjusted odds ratio 0.72 (95% CI 0.55 to 2.36)]. Highly positive free-text comments from intervention participants indicated that the website facilitates contraception choice and can help women feel better prepared before consultation with healthcare providers. INTERPRETATION: The Contraception Choices website was popular for its design, trustworthy information and decision aids but it was not associated with significant differences in use of LARC or satisfaction with contraceptive method. An interactive website can aid contraception choice, but interventions that address factors beyond women's control, such as access to services, and partner, family or community influences are needed to complement this approach. RESEARCH IN CONTEXT: Preventing unintended pregnancy through effective use of contraception is essential for women's health, but choosing between different contraceptive methods can be challenging, and the opportunity for adequate discussion during routine consultations is often constrained. EVIDENCE BEFORE THIS STUDY: We conducted two systematic literature reviews: 1) Factors influencing contraception choice, uptake and use: a meta-synthesis of systematic reviews; and 2) Effectiveness of interactive digital interventions (IDI) for contraception choice, uptake and use. For the first review we searched PubMed, CDSR, Epistemonikos, DoPHER, DARE, NHS Economic Evaluation Database, Campbell Library, NIHR Health Technology Assessment, and Health Evidence Canada databases for systematic reviews which addressed contraceptive choice, uptake or use, from 2000 to 2017. PROSPERO registration number: CRD42017081521 https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=81521. We synthesised the findings of 18 systematic reviews of mostly moderate or high quality. They highlighted the importance of women's knowledge, beliefs, perceptions of side effects and health risks, as well as relationship status, social network, economic and healthcare factors on contraception choice and use. For the second review, we searched 23 electronic databases, trials registers and reference lists for randomised controlled trials of IDI for contraception, including CENTRAL, MEDLINE, EMBASE, CINAHL, ERIC, ASSIA and PsycINFO, from start date to June 2017. PROSPERO registration number: CRD42017081636. We found only five randomised trials of IDI, all from the USA. Risk of bias prevented synthesis of results. www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=81636. ADDED VALUE OF THIS STUDY: Women's common concerns about contraception - fear of hormones, weight gain, cancer, infertility, mood changes, breaks from contraception and changes in bleeding patterns - underpinned development of a new interactive website (www.contraceptionchoices.org). Contraception Choices addresses women's concerns through succinct text; Q and A format (Frequently Asked Questions, Did you Know?; videos of women and health professionals); an effectiveness infographic, and an interactive decision aid (What's right for me?).In an online randomised trial with 927 women attending clinics, we found no association of the Contraception Choices intervention with the primary outcomes - satisfaction with contraceptive method and uptake of long-acting reversible methods at 6 months. Nor did we find an association with secondary adverse outcomes - sexually transmitted infections or pregnancy. Comments from women indicated that the website can meet young women's need for information on the benefits and drawbacks of contraception, help them to make informed decisions, and feel better prepared before healthcare consultations. Contraception Choices is now available on the NHS website: www.nhs.uk/conditions/contraception/which-method-suits-me. IMPLICATIONS OF ALL THE AVAILABLE EVIDENCE: Interactive digital interventions (websites) can aid contraception choice, but other intervention research is needed to address wider influences on unintended pregnancy, including partner views, friends, family, the media, wider society and experiences with healthcare professionals. Future research could examine the impact of the website in different settings, e.g. schools or different countries. We hypothesise that use of the website during contraceptive consultations might improve the efficiency or quality of consultation, for both patients and healthcare providers. Appropriate methodology and time-scale for evaluating digital health interventions remains a key question.

Effectiveness of different post-diagnostic dementia care models delivered by primary care: a systematic review.

BACKGROUND: Global policy recommendations suggest a task-shifted model of post-diagnostic dementia care, moving towards primary and community-based care. It is unclear how this may best be delivered. AIM: To assess the effectiveness and cost-effectiveness of primary care-based models of post-diagnostic dementia care. DESIGN AND SETTING: A systematic review of trials and economic evaluations of post-diagnostic dementia care interventions where primary care was substantially involved in care plan decision making. METHOD: Searches were undertaken of MEDLINE, PsychINFO, EMBASE, Web of Science, and CINAHL (from inception to March 2019). Two authors independently critically appraised studies and inductively classified interventions into types of care models. Random effects meta-analysis or narrative synthesis was conducted for each model where appropriate. RESULTS: From 4506 unique references and 357 full texts, 23 papers were included from 10 trials of nine interventions, delivered in four countries. Four types of care models were identified. Primary care provider (PCP)-led care (n = 1) led to better caregiver mental health and reduced hospital and memory clinic costs compared with memory clinics. PCP-led care with specialist consulting support (n = 2) did not have additional effects on clinical outcomes or costs over usual primary care. PCP-case management partnership models (n = 6) offered the most promise, with impact on neuropsychiatric symptoms, caregiver burden, distress and mastery, and healthcare costs. Integrated primary care memory clinics (n = 1) had limited evidence for improved quality of life and cost-effectiveness compared with memory clinics. CONCLUSION: Partnership models may impact on some clinical outcomes and healthcare costs. More rigorous evaluation of promising primary care-led care models is needed.

Application of the COM-B model to barriers and facilitators to chlamydia testing in general practice for young people and primary care practitioners: a systematic review.

BACKGROUND: Chlamydia is a major public health concern, with high economic and social costs. In 2016, there were over 200,000 chlamydia diagnoses made in England. The highest prevalence rates are found among young people. Although annual testing for sexually active young people is recommended, many do not receive testing. General practice is one ideal setting for testing, yet attempts to increase testing in this setting have been disappointing. The Capability, Opportunity, and Motivation Model of Behaviour (COM-B model) may help improve understanding of the underpinnings of chlamydia testing. The aim of this systematic review was to (1) identify barriers and facilitators to chlamydia testing for young people and primary care practitioners in general practice and (2) map facilitators and barriers onto the COM-B model. METHODS: Qualitative, quantitative, and mixed methods studies published after 2000 were included. Seven databases were searched to identify peer-reviewed publications which examined barriers and facilitators to chlamydia testing in general practice. The quality of included studies was assessed using the Critical Appraisal Skills Programme. Data (i.e., participant quotations, theme descriptions, and survey results) regarding study design and key findings were extracted. The data was first analysed using thematic analysis, following this, the resultant factors were mapped onto the COM-B model components. All findings are reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. RESULTS: Four hundred eleven papers were identified; 39 met the inclusion criteria. Barriers and facilitators were identified at the patient (e.g., knowledge), provider (e.g., time constraints), and service level (e.g., practice nurses). Factors were categorised into the subcomponents of the model: physical capability (e.g., practice nurse involvement), psychological capability (e.g.: lack of knowledge), reflective motivation (e.g., beliefs regarding perceived risk), automatic motivation (e.g., embarrassment and shame), physical opportunity (e.g., time constraints), social opportunity (e.g., stigma). CONCLUSIONS: This systematic review provides a synthesis of the literature which acknowledges factors across multiple levels and components. The COM-B model provided the framework for understanding the complexity of chlamydia testing behaviour. While we cannot at this juncture state which component represents the most salient influence on chlamydia testing, across all three levels, multiple barriers and facilitators were identified relating psychological capability and physical and social opportunity. Implementation should focus on (1) normalisation, (2) communication, (3) infection-specific information, and (4) mode of testing. In order to increase chlamydia testing in general practice, a multifaceted theory- and evidence-based approach is needed. TRIAL REGISTRATION: PROSPERO CRD42016041786.

Supporting shared decision making for older people with multiple health and social care needs: a realist synthesis.

BACKGROUND: Health care systems are increasingly moving towards more integrated approaches. Shared decision making (SDM) is central to these models but may be complicated by the need to negotiate and communicate decisions between multiple providers, as well as patients and their family carers; particularly for older people with complex needs. The aim of this review was to provide a context relevant understanding of how interventions to facilitate SDM might work for older people with multiple health and care needs, and how they might be applied in integrated care models. METHODS: Iterative, stakeholder driven, realist synthesis following RAMESES publication standards. It involved: 1) scoping literature and stakeholder interviews (n = 13) to develop initial programme theory/ies, 2) systematic searches for evidence to test and develop the theories, and 3) validation of programme theory/ies with stakeholders (n = 11). We searched PubMed, The Cochrane Library, Scopus, Google, Google Scholar, and undertook lateral searches. All types of evidence were included. RESULTS: We included 88 papers; 29 focused on older people or people with complex needs. We identified four context-mechanism-outcome configurations that together provide an account of what needs to be in place for SDM to work for older people with complex needs. This includes: understanding and assessing patient and carer values and capacity to access and use care, organising systems to support and prioritise SDM, supporting and preparing patients and family carers to engage in SDM and a person-centred culture of which SDM is a part. Programmes likely to be successful in promoting SDM are those that allow older people to feel that they are respected and understood, and that engender confidence to engage in SDM. CONCLUSIONS: To embed SDM in practice requires a radical shift from a biomedical focus to a more person-centred ethos. Service providers will need support to change their professional behaviour and to better organise and deliver services. Face to face interactions, permission and space to discuss options, and continuity of patient-professional relationships are key in supporting older people with complex needs to engage in SDM. Future research needs to focus on inter-professional approaches to SDM and how families and carers are involved.

Self-sampling kits to increase HIV testing among black Africans in the UK: the HAUS mixed-methods study.

BACKGROUND: Timely diagnosis of human immunodeficiency virus (HIV) enables access to antiretroviral treatment, which reduces mortality, morbidity and further transmission in people living with HIV. In the UK, late diagnosis among black African people persists. Novel methods to enhance HIV testing in this population are needed. OBJECTIVES: To develop a self-sampling kit (SSK) intervention to increase HIV testing among black Africans, using existing community and health-care settings (stage 1) and to assess the feasibility for a Phase III evaluation (stage 2). DESIGN: A two-stage, mixed-methods design. Stage 1 involved a systematic literature review, focus groups and interviews with key stakeholders and black Africans. Data obtained provided the theoretical base for intervention development and operationalisation. Stage 2 was a prospective, non-randomised study of a provider-initiated, HIV SSK distribution intervention targeted at black Africans. The intervention was assessed for cost-effectiveness. A process evaluation explored feasibility, acceptability and fidelity. SETTING: Twelve general practices and three community settings in London. MAIN OUTCOME MEASURE: HIV SSK return rate. RESULTS: Stage 1 - the systematic review revealed support for HIV SSKs, but with scant evidence on their use and clinical effectiveness among black Africans. Although the qualitative findings supported SSK distribution in settings already used by black Africans, concerns were raised about the complexity of the SSK and the acceptability of targeting. These findings were used to develop a theoretically informed intervention. Stage 2 - of the 349 eligible people approached, 125 (35.8%) agreed to participate. Data from 119 were included in the analysis; 54.5% (65/119) of those who took a kit returned a sample; 83.1% of tests returned were HIV negative; and 16.9% were not processed, because of insufficient samples. Process evaluation showed the time pressures of the research process to be a significant barrier to feasibility. Other major barriers were difficulties with the SSK itself and ethnic targeting in general practice settings. The convenience and privacy associated with the SSK were described as beneficial aspects, and those who used the kit mostly found the intervention to be acceptable. Research governance delays prevented implementation in Glasgow. LIMITATIONS: Owing to the study failing to recruit adequate numbers (the intended sample was 1200 participants), we were unable to evaluate the clinical effectiveness of SSKs in increasing HIV testing in black African people. No samples were reactive, so we were unable to assess pathways to confirmatory testing and linkage to care. CONCLUSIONS: Our findings indicate that, although aspects of the intervention were acceptable, ethnic targeting and the SSK itself were problematic, and scale-up of the intervention to a Phase III trial was not feasible. The preliminary economic model suggests that, for the acceptance rate and test return seen in the trial, the SSK is potentially a cost-effective way to identify new infections of HIV. FUTURE WORK: Sexual and public health services are increasingly utilising self-sampling technologies. However, alternative, user-friendly SSKs that meet user and provider preferences and UK regulatory requirements are needed, and additional research is required to understand clinical effectiveness and cost-effectiveness for black African communities. STUDY REGISTRATION: This study is registered as PROSPERO CRD42014010698 and Integrated Research Application System project identification 184223. FUNDING: The National Institute for Health Research Health Technology Assessment programme and the BHA for Equality in Health and Social Care.

Managing diabetes in people with dementia: a realist review.

BACKGROUND: Dementia and diabetes mellitus are common long-term conditions that coexist in a large number of older people. People living with dementia and diabetes may be at increased risk of complications such as hypoglycaemic episodes because they are less able to manage their diabetes. OBJECTIVES: To identify the key features or mechanisms of programmes that aim to improve the management of diabetes in people with dementia and to identify areas needing further research. DESIGN: Realist review, using an iterative, stakeholder-driven, four-stage approach. This involved scoping the literature and conducting stakeholder interviews to develop initial programme theories, systematic searches of the evidence to test and develop the theories, and the validation of programme theories with a purposive sample of stakeholders. PARTICIPANTS: Twenty-six stakeholders (user/patient representatives, dementia care providers, clinicians specialising in dementia or diabetes and researchers) took part in interviews and 24 participated in a consensus conference. DATA SOURCES: The following databases were searched from 1990 to March 2016: MEDLINE (PubMed), Cumulative Index to Nursing and Allied Health Literature, Scopus, The Cochrane Library (including the Cochrane Database of Systematic Reviews), Database of Abstracts of Reviews of Effects, the Health Technology Assessment (HTA) database, NHS Economic Evaluation Database, AgeInfo (Centre for Policy on Ageing - UK), Social Care Online, the National Institute for Health Research (NIHR) portfolio database, NHS Evidence, Google (Google Inc., Mountain View, CA, USA) and Google Scholar (Google Inc., Mountain View, CA, USA). RESULTS: We included 89 papers. Ten papers focused directly on people living with dementia and diabetes, and the rest related to people with dementia or diabetes or other long-term conditions. We identified six context-mechanism-outcome (CMO) configurations that provide an explanatory account of how interventions might work to improve the management of diabetes in people living with dementia. This includes embedding positive attitudes towards people living with dementia, person-centred approaches to care planning, developing skills to provide tailored and flexible care, regular contact, family engagement and usability of assistive devices. A general metamechanism that emerges concerns the synergy between an intervention strategy, the dementia trajectory and social and environmental factors, especially family involvement. A flexible service model for people with dementia and diabetes would enable this synergy in a way that would lead to the improved management of diabetes in people living with dementia. LIMITATIONS: There is little evidence relating to the management of diabetes in people living with dementia, although including a wider literature provided opportunities for transferable learning. The outcomes in our CMOs are largely experiential rather than clinical. This reflects the evidence available. Outcomes such as increased engagement in self-management are potential surrogates for better clinical management of diabetes, but this is not proven. CONCLUSIONS: This review suggests that there is a need to prioritise quality of life, independence and patient and carer priorities over a more biomedical, target-driven approach. Much current research, particularly that specific to people living with dementia and diabetes, identifies deficiencies in, and problems with, current systems. Although we have highlighted the need for personalised care, continuity and family-centred approaches, there is much evidence to suggest that this is not currently happening. Future research on the management of diabetes in older people with complex health needs, including those with dementia, needs to look at how organisational structures and workforce development can be better aligned to the needs of people living with dementia and diabetes. STUDY REGISTRATION: This study is registered as PROSPERO CRD42015020625. FUNDING: The NIHR HTA programme.

Costs of vitamin D testing and prescribing among children in primary care.

Vitamin D has attracted considerable interest in recent years, with a marked increase in diagnosis of vitamin D deficiency seen among children in clinical practice in the UK. The economic implications of this change in diagnostic behaviour have not been explored. We performed a cohort study to examine longitudinal trends in healthcare expenditure arising from vitamin D testing and prescribing for children in primary care in England, using the electronic healthcare records of 722,525 children aged 0-17 years held in The Health Improvement Network database. Combined costs of vitamin D tests and prescriptions increased from £1647 per 100,000 person-years in 2008 (95% CI, £934 to £3007) to £28,913 per 100,000 person-years in 2014 (95% CI, £26,361 to £31,739). The total cost of vitamin D prescriptions and tests for children in primary care at the national level in England in 2014 was estimated to be £4.31 million (95% CI, £2.96-£6.48 million). CONCLUSION: There has been a marked increase in healthcare expenditure on vitamin D tests and prescriptions for children in primary care over the past decade. Future research should explore the drivers for this change in diagnostic behaviour and the reasons prompting investigation of vitamin D status in clinical practice. What is Known: • Vitamin D deficiency has attracted considerable interest in recent years, with a marked increase in diagnosis seen in children. • The economic implications of this change in diagnostic behaviour have not been explored. What is New: • There has been a large increase in healthcare expenditure on vitamin D tests and prescriptions for children in primary care in England over the past decade (> 15 fold between 2008 and 2013). • Screening of vitamin D status in children without specific risk factors or clinical features of deficiency may represent avoidable healthcare expenditure.

Supporting shared decision-making for older people with multiple health and social care needs: a protocol for a realist synthesis to inform integrated care models.

INTRODUCTION: Including the patient or user perspective is a central organising principle of integrated care. Moreover, there is increasing recognition of the importance of strengthening relationships among patients, carers and practitioners, particularly for individuals receiving substantial health and care support, such as those with long-term or multiple conditions. The overall aims of this synthesis are to provide a context-relevant understanding of how models to facilitate shared decision-making (SDM) might work for older people with multiple health and care needs, and how they might be applied to integrated care models. METHODS AND ANALYSIS: The synthesis draws on the principles of realist inquiry, to explain how, in what contexts and for whom, interventions that aim to strengthen SDM among older patients, carers and practitioners are effective. We will use an iterative, stakeholder-driven, three-phase approach. Phase 1: development of programme theory/theories that will be tested through a first scoping of the literature and consultation with key stakeholder groups; phase 2: systematic searches of the evidence to test and develop the theories identified in phase 1; phase 3: validation of programme theory/theories with a purposive sample of participants from phase 1. The synthesis will draw on prevailing theories such as candidacy, self-efficacy, personalisation and coproduction. ETHICS AND DISSEMINATION: Ethics approval for the stakeholder interviews was obtained from the University of Hertfordshire ECDA (Ethics Committee with Delegated Authority), reference number HSK/SF/UH/02387. The propositions arising from this review will be used to develop recommendations about how to tailor SDM interventions to older people with complex health and social care needs in an integrated care setting.

Healthcare organisation and delivery for people with dementia and comorbidity: a qualitative study exploring the views of patients, carers and professionals.

OBJECTIVES: People living with dementia (PLWD) have a high prevalence of comorbidty. The aim of this study was to explore the impact of dementia on access to non-dementia services and identify ways of improving service delivery for this population. DESIGN: Qualitative study involving interviews and focus groups. Thematic content analysis was informed by theories of continuity of care and access to care. SETTING: Primary and secondary care in the South and North East of England. PARTICIPANTS: PLWD who had 1 of the following comorbidities-diabetes, stroke, vision impairment, their family carers and healthcare professionals (HCPs) in the 3 conditions. RESULTS: We recruited 28 community-dwelling PLWD, 33 family carers and 56 HCPs. Analysis resulted in 3 overarching themes: (1) family carers facilitate access to care and continuity of care, (2) the impact of the severity and presentation of dementia on management of comorbid conditions, (3) communication and collaboration across specialities and services is not dementia aware. We found examples of good practice, but these tended to be about the behaviour of individual practitioners rather than system-based approaches; current systems may unintentionally block access to care for PLWD. CONCLUSIONS: This study suggests that, in order to improve access and continuity for PLWD and comorbidity, a significant change in the organisation of care is required which involves: coproduction of care where professionals, PLWD and family carers work in partnership; recognition of the way a patient's diagnosis of dementia affects the management of other long-term conditions; flexibility in services to ensure they are sensitive to the changing needs of PLWD and their family carers over time; and improved collaboration across specialities and organisations. Research is needed to develop interventions that support partnership working and tailoring of care for PLWD and comorbidity.

The Men's Safer Sex project: intervention development and feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men.

BACKGROUND: This report details the development of the Men's Safer Sex website and the results of a feasibility randomised controlled trial (RCT), health economic assessment and qualitative evaluation. OBJECTIVES: (1) Develop the Men's Safer Sex website to address barriers to condom use; (2) determine the best design for an online RCT; (3) inform the methods for collecting and analysing health economic data; (4) assess the Sexual Quality of Life (SQoL) questionnaire and European Quality of Life-5 Dimensions, three-level version (EQ-5D-3L) to calculate quality-adjusted life-years (QALYs); and (5) explore clinic staff and men's views of online research methodology. METHODS: (1) Website development: we combined evidence from research literature and the views of experts (n = 18) and male clinic users (n = 43); (2) feasibility RCT: 159 heterosexually active men were recruited from three sexual health clinics and were randomised by computer to the Men's Safer Sex website plus usual care (n = 84) or usual clinic care only (n = 75). Men were invited to complete online questionnaires at 3, 6, 9 and 12 months, and sexually transmitted infection (STI) diagnoses were recorded from clinic notes at 12 months; (3) health economic evaluation: we investigated the impact of using different questionnaires to calculate utilities and QALYs (the EQ-5D-3L and SQoL questionnaire), and compared different methods to collect resource use; and (4) qualitative evaluation: thematic analysis of interviews with 11 male trial participants and nine clinic staff, as well as free-text comments from online outcome questionnaires. RESULTS: (1) Software errors and clinic Wi-Fi access presented significant challenges. Response rates for online questionnaires were poor but improved with larger vouchers (from 36% with £10 to 50% with £30). Clinical records were located for 94% of participants for STI diagnoses. There were no group differences in condomless sex with female partners [incidence rate ratio (IRR) 1.01, 95% confidence interval (CI) 0.52 to 1.96]. New STI diagnoses were recorded for 8.8% (7/80) of the intervention group and 13.0% (9/69) of the control group (IRR 0.75, 95% CI 0.29 to 1.89). (2) Health-care resource data were more complete using patient files than questionnaires. The probability that the intervention is cost-effective is sensitive to the source of data used and whether or not data on intended pregnancies are included. (3) The pilot RCT fitted well around clinical activities but 37% of the intervention group did not see the Men's Safer Sex website and technical problems were frustrating. Men's views of the Men's Safer Sex website and research procedures were largely positive. CONCLUSIONS: It would be feasible to conduct a large-scale RCT using clinic STI diagnoses as a primary outcome; however, technical errors and a poor response rate limited the collection of online self-reported outcomes. The next steps are (1) to optimise software for online trials, (2) to find the best ways to integrate digital health promotion with clinical services, (3) to develop more precise methods for collecting resource use data and (4) to work out how to overcome barriers to digital intervention testing and implementation in the NHS. TRIAL REGISTRATION: Current Controlled Trials ISRCTN18649610. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 91. See the NIHR Journals Library website for further project information.

Recording of Influenza-Like Illness in UK Primary Care 1995-2013: Cohort Study.

BACKGROUND: There is a lack of recent studies examining recording of influenza-like illness (ILI) in primary care in the UK over time and according to population characteristics. Our aim was to determine time trends and socio-demographic patterns of ILI recorded consultations in primary care. METHODS: We used The Health Improvement Network (THIN) UK primary care database and extracted data on all ILI consultations between 1995 and 2013. We estimated ILI recorded consultation rates per 100,000 person-weeks (pw) by age, gender, deprivation and winter season. Negative binomial regression models were used to examine time trends and the effect of socio-demographic characteristics. Trends in ILI recorded consultations were compared to trends in consultations with less specific symptoms (cough or fever) recorded. RESULTS: The study involved 7,682,908 individuals in 542 general practices. The ILI consultation rate decreased from 32.5/100,000 pw (95% confidence interval (CI) 32.1, 32.9) in 1995-98 to 15.5/100,000 pw (95% CI 15.4, 15.7) by 2010-13. The decrease occurred prior to 2002/3, and rates have remained largely stable since then. Declines were evident in all age groups. In comparison, cough or fever consultation rates increased from 169.4/100,000 pw (95% CI 168.6, 170.3) in 1995-98 to 237.7/100,000 pw (95% CI 237.2, 238.2) in 2010-13. ILI consultation rates were highest among individuals aged 15-44 years, higher in women than men, and in individuals from deprived areas. CONCLUSION: There is substantial variation in ILI recorded consultations over time and by population socio-demographic characteristics, most likely reflecting changing recording behaviour by GPs. These results highlight the difficulties in using coded information from electronic primary care records to measure the severity of influenza epidemics across time and assess the relative burden of ILI in different population subgroups.

The Men's Safer Sex (MenSS) trial: protocol for a pilot randomised controlled trial of an interactive digital intervention to increase condom use in men.

INTRODUCTION: Sexually transmitted infections (STI) are a major public health problem. Condoms provide effective protection but there are many barriers to use. Face-to-face health promotion interventions are resource-intensive and show mixed results. Interactive digital interventions may provide a suitable alternative, allowing private access to personally tailored behaviour change support. We have developed an interactive digital intervention (the Men's Safer Sex (MenSS) website) which aims to increase condom use in men. We describe the protocol for a pilot trial to assess the feasibility of a full-scale randomised controlled trial of the MenSS website in addition to usual sexual health clinical care. PARTICIPANTS: Men aged 16 or over who report female sexual partners and recent unprotected sex or suspected acute STI. PARTICIPANTS (N=166) will be enrolled using a tablet computer in clinic waiting rooms. All trial procedures will be online, that is, eligibility checks; study consent; trial registration; automated random allocation; and data submission. At baseline and at 3, 6 and 12 months, an online questionnaire will assess condom use, self-reported STI diagnoses, and mediators of condom use (eg, knowledge, intention). Reminders will be by email and mobile phone. The primary outcome is condom use, measured at 3 months. STI rates will be recorded from sexual health clinic medical records at 12 months. The feasibility of a cost-effectiveness analysis will be assessed, to calculate incremental cost per STI prevented (Chlamydia or Gonorrhoea), from the NHS perspective. ETHICS AND DISSEMINATION: Ethical approval: City and East NHS Research Ethics Committee (reference number 13 LO 1801). Findings will be made available through publication in peer-reviewed journals, and to participants and members of the public via Twitter and from the University College London eHealth Unit website. Raw data will be made available on request. TRIAL REGISTRATION NUMBER: Current Controlled Trials. ISRCTN18649610. Registered 15 October 2013 http://www.controlled-trials.com/ISRCTN18649610.

The relative clinical effectiveness and cost-effectiveness of three contrasting approaches to partner notification for curable sexually transmitted infections: a cluster randomised trial in primary care.

BACKGROUND: Partner notification is the process of providing support for, informing and treating sexual partners of individuals who have been diagnosed with sexually transmitted infections (STIs). It is traditionally undertaken by specialist sexual health services, and may involve informing a partner on a patient's behalf, with consent. With an increasing proportion of STIs diagnosed in general practice and other community settings, there is a growing need to understand the best way to provide partner notification for people diagnosed with a STI in this setting using a web-based referral system. OBJECTIVE: We aimed to compare three different approaches to partner notification for people diagnosed with chlamydia within general practice. DESIGN: Cluster randomised controlled trial. SETTING: General practices in England and, within these, patients tested for and diagnosed with genital chlamydia or other bacterial STIs in that setting using a web-based referral system. INTERVENTIONS: Three different approaches to partner notification: patient referral alone, or the additional offer of either provider referral or contract referral. MAIN OUTCOME MEASURES: (1) Number of main partners per index patient treated for chlamydia and/or gonorrhoea/non-specific urethritis/pelvic inflammatory disease; and (2) proportion of index patients testing negative for the relevant STI at 3 months. RESULTS: As testing rates for chlamydia were far lower than expected, we were unable to scale up the trial, which was concluded at pilot stage. We are not able to answer the original research question. We present the results of the work undertaken to improve recruitment to similar studies requiring opportunistic recruitment of young people in general practice. We were unable to standardise provider and contract referral separately; however, we also present results of qualitative work aimed at optimising these interventions. CONCLUSIONS: External recruitment may be required to facilitate the recruitment of young people to research in general practice, especially in sensitive areas, because of specific barriers experienced by general practice staff. Costs need to be taken into account together with feasibility considerations. Partner notification interventions for bacterial STIs may not be clearly separable into the three categories of patient, provider and contract referral. Future research is needed to operationalise the approaches of provider and contract partner notification if future trials are to provide generalisable information. TRIAL REGISTRATION: Current Controlled Trials ISRCTN24160819. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 5. See the NIHR Journals Library website for further project information.