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Background: Following the 2019 NHS Long Term Plan, link workers have been employed across primary care in England to deliver social prescribing., Aim: To understand and explain how the link worker role is being implemented in primary care in England., Design and Setting: This was a realist evaluation undertaken in England, focusing on link workers based in primary care., Method: The study used focused ethnographies around seven link workers from different parts of England. As part of this, we interviewed 61 patients and 93 professionals from health care and the voluntary, community, and social enterprise sector. We reinterviewed 41 patients, seven link workers, and a link worker manager 9-12 months after their first interview., Results: We developed four concepts from the codes developed during the project on the topic around how link workers are integrated (or not) within primary care: (or not) within primary care: centralising or diffusing power; forging an identity in general practice; demonstrating effect; and building a facilitative infrastructure. These concepts informed the development of a programme theory around a continuum of integration of link workers into primary care - from being 'bolted on' to existing provision, without much consideration, to 'fitting in', shaping what is delivered to be accommodating, through to 'belonging', whereby they are accepted as a legitimate source of support, making a valued contribution to patients' broader wellbeing., Conclusion: Social prescribing was introduced into primary care to promote greater attention to the full range of factors affecting patients' health and wellbeing, beyond biomedicine. For that to happen, our analysis highlights the need for a whole-system approach to defining, delivering, and maintaining this new part of practice., (© The Authors.)

Background: In response to the unsustainable workload and workforce crises in primary care, paramedics (with their generalist clinical background acquired from ambulance service experience) are increasingly employed in primary care. However, the specific contribution paramedics can offer to the primary care workforce has not been distinctly outlined. We used realist approaches to understand the ways in which paramedics impact (or not) the primary care workforce., Methods: A realist evaluation was undertaken, consisting of three independent but inter-related research studies: In WP1, a mixed-methods cross-sectional survey of paramedics in primary care in the UK was conducted to comprehend the existing practices of paramedics within the NHS. WP2 involved an analytic auto-netnography, where online conversations among paramedics in primary care were observed to understand paramedics' perceptions of their role. WP3 utilised focused observations and interviews to delve into the impact of paramedics on the primary care workforce. This comparative study collected data from sixty participants across fifteen sites in the UK, and twelve participants across three sites in a specific region in Canada, where Community Paramedicine is well established., Results: The culmination of findings from each phase led to the development of a final programme theory, comprising of 50 context-mechanism-outcome configurations (CMOCs) encompassing three conceptual categories: Expectations associated with paramedics in primary care, the transition of paramedics into primary care roles, and the roles and responsibilities of paramedics in primary care., Conclusions: Our realist evaluation used a mixed-method approach to present empirical evidence of the role of paramedics in primary care. It offers insights into factors relating to their deployment, employment, and how they fit within the wider primary care team. Based on the evidence generated, we produced a series of practice implementation recommendations and highlighted areas for further research., Competing Interests: Declarations. Ethics approval and consent to participate: WP1 was approved by the Central University Research Ethics Committee (MS IDREC Ref: R64129/RE001) at the University of Oxford. WP2 was approved by the Central University Research Ethics Committee (MS IDREC Ref: R77299/RE001) at the University of Oxford. WP3 was approved to be undertaken in the UK by the Central University Research Ethics Committee at the University of Oxford and the Health Research Authority (22/NW/0097). It was approved to be undertaken within the County of Renfrew Paramedic Service, Ontario, Canada by the Oxford Tropical Research Ethics Committee (OxTREC Reference: 524–22). Consent for publication: N/A. Competing interests: The authors declare no competing interests., (© 2025. The Author(s).)

Introduction: Social prescribing addresses non-medical issues (e.g., loneliness, financial worries, housing problems) affecting physical and/or mental health. It involves connecting people to external support or services, including 'cultural offers'-events, groups and activities run within or by cultural organisations. Such offers need to be acceptable and accessible to diverse populations if forming part of a social prescription., Methods: A scoping review was conducted to identify what existing literature, conducted in the United Kingdom, tells us about tailoring cultural offers for older people (aged 60+ years) from ethnic minority groups. Relevant literature was searched for on electronic databases, through Google, via a questionnaire to cultural organisations and by contacting the study's advisory group., Results: Screening of 906 references-59 of which were read as full documents-resulted in six sources being included in the review. Some cultural activities described within them were run in traditional cultural spaces (e.g., museums, art galleries). Others were held in community centres. Data suggested that attending with others could reduce concerns about belonging. Barriers to engagement included low energy, language, poor confidence, accessing transport and unfamiliarity with a setting and/or activities. Provision of familiar food could help make people feel welcomed., Conclusions: Reviewed papers showed that consulting with target groups is important to ensure that activities are inclusive and sympathetically delivered. The review also highlighted a paucity of published research on the topic; this means that cultural providers have little evidence to draw on when developing cultural offers for older people from ethnic minority groups., Competing Interests: The authors declare no conflicts of interest., (© 2024 The Author(s). Lifestyle Medicine published by John Wiley & Sons Ltd.)

Introduction: Paramedics in the UK are moving from emergency ambulance services into primary care, where they are employed to boost the clinical workforce. Whereas there is emerging research that seeks to understand the contribution of paramedics to the primary care workforce, there is none regarding the perceptions paramedics have regarding their role in primary care., Methods: An analytic auto-ethnography was undertaken, utilising a peripheral membership approach for online communities used by paramedics on Facebook, Reddit and Twitter (now X). Over a 3-month period (December 2021 to February 2022), the primary researcher reflected on the conversations, comments and opinions posted within these communities within a reflexive (immersion) journal, considering them against the context of her own experience., Results: Paramedics in primary care, who are generally isolated due to their geographical isolation from each other, utilise online social spaces to foster a community of practice. These forums are used to discuss their clinical role, education and experiences, as well as to consider their place within the primary care workforce., Conclusion: This is the first application of this methodology within online social spaces utilised by UK paramedics. This article also presents novel use of a peripheral membership approach within an analytic auto-netnography in public online spaces for researcher-practitioners., Competing Interests: None declared., (© 2021 The Author(s).)

Objectives: Collaborative and integrated (C + I) working between general practice and community pharmacies has the potential to increase accessibility to services, improve service efficiency and quality of care, and reduce health care expenditures. Many existing studies report challenges and complexities inherent in establishing effective C + I ways of working. The aim of our review is to understand how, when and why working arrangements between General Practitioners (GP) and Community Pharmacists (CP) can provide the conditions necessary for effective communication, decision-making, and C + I working., Methods: We conducted a realist review to explore the key contextual factors and mechanisms through which GP-CP C + I working may be achieved. MEDLINE, Embase, CINAHL, PsycINFO, HMIC, Web of Science, IBSS, ASSIA, Sociological Abstracts, Sociology Database and the King's Fund Library Database were searched for articles and grey literature published between January 2000 and April 2022., Results: A total of 136 documents were included in the final synthesis. Our findings highlight the importance of mutually beneficial remuneration models to support effective integration of services; supportive organisational cultures and values; flexible and agile IT systems/technologies; adequate physical infrastructure and space design to support multidisciplinary teamworking; the importance of establishing patient's trust in collaborative processes between GP-CP; and the need to acknowledge, support and utilise effective triadic relationships., Conclusions: Our research generates new insights regarding how, why and in which contexts C + I working can be achieved between GPs and CPs. The findings of our review can be used to inform future policy, research and clinical practice guidelines for designing and delivering C + I care., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Social prescribing link workers have become part of primary health care in recent years. They help patients to recognise non-medical factors affecting their health and identify sources of support, often in the voluntary, community and social enterprise sector. They form part of wider work to strengthen person-centred care, which actively seeks to engage individuals in decision-making about their health, taking into account their medical, social, psychological, financial and spiritual circumstances., Objective: To understand how buy-in to social prescribing and the link worker role is established for a patient, and how this relates to person-centred care., Design: A realist evaluation., Setting: Patients engaging with link workers in seven different parts of England were involved., Methods: As part of data collection, we observed link workers interacting with 35 patients. We also interviewed 61 patients and re-interviewed 41 of them 9-12 months later. Data were coded and developed into context-mechanism-outcome configurations, which were used to produce a programme theory., Results: Data highlighted how patients might be uncertain about the link worker role but agree to a referral as they sought assistance with their non-medical issues. Patients talked about experiencing a sense of hope through the trust they developed in a link worker. This trust was established through the communication skills and knowledge demonstrated by a link worker, and by their ability to act as an anchor point when required - a reliable, consistent source of support to whom patients could offload. The link worker role also involved connecting patients to external support, which called for sensitivity around how ready someone was to move forward; this was shaped by a patient's motivation but also their capacity to make changes given other demands in their life. Connecting patients to external support could be affected by structural factors outside the link workers' control (e.g. housing options or employment opportunities)., Limitations: We did not interview patients who had rejected the offer of social prescribing, and most had a positive view of meeting with a link worker., Conclusions: Person-centred care is engendered by link workers through their skills, knowledge and ability to respond to the individual readiness of patients to engage with external support. It can be curtailed by structural factors outside link workers' sphere of control, such as access to housing or caring responsibilities of patients. This can hinder patients' ability to 'connect to', leaving link workers to continue 'connecting with' patients as they act as an anchor point., Future Work: Exploration is required of factors affecting patients who interact with a link worker but do not access external support. Longitudinal work with a cohort of patients, speaking to them on a regular basis, may provide further understanding in this respect., Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number NIHR130247.

Background: Social prescribing addresses non-medical factors affecting health and well-being. Link workers are key to its delivery by connecting people to relevant support, often in the voluntary, community and social enterprise sector. Funding from the National Health Service means that link workers are becoming a common part of primary care in England., Objective: To explore and understand the implementation of link workers in primary care in England., Design: A realist evaluation addressed the question - When implementing link workers in primary care to sustain outcomes - what works, for whom, why and in what circumstances?, Setting: Link workers and staff associated with seven primary care sites across England., Methods: Researchers spent 3 weeks with each link worker, going to meetings with them, watching them interact with patients, with healthcare staff and with voluntary, community and social enterprise organisations. In addition, interviews were conducted with 61 patients and 93 professionals (voluntary, community and social enterprise representatives and healthcare staff, including link workers). Follow-up interviews were conducted with 41 patients and with link workers 9-12 months later. Data were coded and developed into statements to identify how context around the link worker triggers mechanisms that lead to intended and unintended outcomes., Results: We found that link workers exercise micro-discretions in their role - actions and advice-giving based on personal judgement of a situation, which may not always reflect explicit guidance or protocols. Our analysis highlighted that micro-discretions engender positive connections (with patients, healthcare staff, the voluntary, community and social enterprise sector) and promote buy-in to the link worker role in primary care. Micro-discretions supported delivery of person-centred care and enhanced job satisfaction. Data also highlighted that lack of boundaries could place link workers at risk of overstepping their remit., Limitations: Our research focused on link workers attached to primary care; findings may not be applicable to those working in other settings. Data were collected around seven link worker cases, who were selected purposively for variation in terms of geographical spread and how/by whom link workers were employed. However, these link workers were predominately white females., Conclusions: Enabling link workers to exercise micro-discretions allows for responsiveness to individual patient needs but can result in uncertainty and to link workers feeling overstretched., Future Work: Poor link worker retention may, in part, be associated with a lack of clarity around their role. Research to explore how this shapes intention to leave their job is being conducted by authors of this paper., Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number NIHR130247.

Background: Social prescribing is gaining traction internationally. It is an approach which seeks to address non-medical and health-related social needs through taking a holistic person-centred and community-based approach. This involves connecting people with and supporting them to access groups and organisations within their local communities. It is hoped that social prescribing might improve health inequities and reduce reliance on healthcare services. In the UK, social prescribing link workers have become core parts of primary care teams. Despite growing literature on the implementation of social prescribing, to date there has been no synthesis that develops a theoretical understanding of the factors that shape link workers' experiences of their role., Methods: We undertook a meta-ethnographic evidence synthesis of qualitative literature to develop a novel conceptual framework that explains how link workers experience their roles. We identified studies using a systematic search of key databases, Google alerts, and through scanning reference lists of included studies. We followed the eMERGe guidance when conducting and reporting this meta-ethnography., Results: Our synthesis included 21 studies and developed a "line of argument" or overarching conceptual framework which highlighted inherent and interacting tensions present at each of the levels that social prescribing operates. These tensions may arise from a mismatch between the policy logic of social prescribing and the material and structural reality, shaped by social, political, and economic forces, into which it is being implemented., Conclusions: The tensions highlighted in our review shape link workers' experiences of their role. They may call into question the sustainability of social prescribing and the link worker role as currently implemented, as well as their ability to deliver desired outcomes such as reducing health inequities or healthcare service utilisation. Greater consideration should be given to how the link worker role is defined, deployed, and trained. Furthermore, thought should be given to ensuring that the infrastructure into which social prescribing is being implemented is sufficient to meet needs. Should social prescribing seek to improve outcomes for those experiencing social and economic disadvantage, it may be necessary for social prescribing models to allow for more intensive and longer-term modes of support., (© 2024. The Author(s).)

Introduction: Treatment-resistant depression (TRD) is depression unresponsive to antidepressants and affects 55% of British primary care users with depression. Current evidence is from secondary care, but long referral times mean general practitioners (GPs) manage TRD. Studies show that people with depression use Twitter to form community and document symptoms. However, Twitter remains a largely unexplored space of documented patient experience. Twitter data could provide valuable insights into learning about primary care experiences of TRD. In this study, we explored Twitter comments and conversations about TRD and produced patient-driven recommendations., Methods: Tweets from UK-based users were collected manually and using a browser extension in June 2021. Conventional content analysis was used to provide an overview of the Tweets, followed by interpretation to understand why Twitter may be important to people with TRD., Results: A total of 415 Tweets were organised into five clusters: self-diagnosis, symptoms, support, small wins and condition experts. These Tweets were interpreted as showing Twitter as a community for people with TRD. People had a collective sense of illness identity and were united in their experiences of TRD. However, users in the community also highlighted the absence of effective GP care, leading users to position themselves as condition experts. Users shared advice from a place of lived experience with the community but also shared potentially harmful information, including recommendations about nonevidence-based medications., Conclusions: Findings illuminate the benefits of the TRD Twitter community and also highlight that the perception of a lack of knowledge and support from GPs may lead community members to advise nonevidenced-based medications., Patient and Public Contribution: This study was led by a person with lived experience of TRD and bipolar. Two public contributors with mental health conditions gave feedback on our study protocol and results., (© 2023 The Authors. Health Expectations published by John Wiley & Sons Ltd.)

Background: International trends have shifted to creating large general practices. There is an assumption that interdisciplinary teams will increase patient accessibility and provide more cost-effective, efficient services. Micro-teams have been proposed to mitigate for some potential challenges of practice expansion, including continuity of care., Aim: To review available literature and examine how micro-teams are described, and identify opportunities and limitations for patients and practice staff., Design and Setting: This was an international systematic review of studies published in English., Method: Databases (MEDLINE, EMBASE, CINAHL, Cochrane Library, and Scopus) and grey literature were searched. Studies were included if they provided evidence about implementation of primary care micro-teams. Framework analysis was used to synthesise identified literature. The research team included a public contributor co-applicant. The authors conducted stakeholder discussions with those with and without experience of micro-team implementation., Results: Of the 462 studies identified, 24 documents met the inclusion criteria. Most included empirical data from healthcare professionals, describing micro-team implementation. Results included characteristics of the literature; micro-team description; range of ways micro-teams have been implemented; reported outcomes; and experiences of patients and staff., Conclusion: The organisation of primary care has potential impact on the nature and quality of patient care, safety, and outcomes. This review contributes to current debate about care delivery and how this can impact on the experiences and outcomes of patients and staff. This analysis identifies several key opportunities and challenges for future research, policy, and practice., (© The Authors.)

Social prescribing is a non-clinical approach to addressing social, environmental, and economic factors affecting how people feel physical and/or emotionally. It involves connecting people to "community assets" (e.g., local groups, organizations, and charities) that can contribute to positive well-being. We sought to explain in what ways, for whom, and why the cultural sector can support social prescribing with older people. We conducted semi-structured interviews with 28 older people (aged 60+) and 25 cultural sector staff. The following nine concepts, developed from interview data, progressed the understanding of tailoring cultural offers, which came from our previous realist review- immersion, buddying, café culture, capacity, emotional involvement, perseverance, autonomy, elitism, and virtual cultural offers. Through tailoring, we propose that older people might experience one or more of the following benefits from engaging with a cultural offer as part of social prescribing-being immersed, psychological holding, connecting, and transforming through self-growth.

Background: Clinical guidelines should be based on a thorough evaluation of the evidence and generally include a rating of the quality of evidence and assign a strength to recommendations. Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidance warns against making strong recommendations when the certainty of the evidence is low or very low, but has identified five paradigmatic situations (e.g. life-threatening situations) where this may be justified., Aims and Objectives: We aimed to characterize the strength of recommendations and certainty of the evidence in Irish National Clinical Guidelines using the GRADE approach., Methods: All National Clinical Guidelines from the National Clinical Effectiveness Committee (NCEC) website using the GRADE approach (fully or partially) were included. All recommendations and their corresponding certainty of the evidence, strength of recommendations and justifications were extracted. Authors classified instances of strong recommendations with low certainty evidence (referred to as discordant recommendations) into one of the five paradigmatic situations. Descriptive statistics were calculated., Results: From the 29 NCEC Clinical Guidelines available at the time of analysis, we identified 8 guidelines using GRADE with a total of 240 recommendations; 38 recommendations did not use the GRADE approach and were excluded. Half of the included guidelines focused on emergency situations. In the final dataset of 202 recommendations, 151 (74.7%) were classified as strong and 51 (25.3%) as conditional. Of the 151 strong recommendations, 55 (36.4%) were supported by high or moderate certainty evidence and 96 (63.6%) by low or very low certainty evidence and were considered discordant. Of these 96 discordant recommendations, 55 (73.7%) were consistent with one of the five paradigmatic situations. However, none were specifically described as such within the guidelines., Conclusions: The proportion of discordant recommendations identified in this analysis was higher than some previous international studies (range of all strong recommendations being discordant 30-50%), but similar to other guidelines focused on emergency situations. The majority of discordant recommendations could be mapped to one of the five situations, but no National Clinical Guideline explicitly referenced this. Guideline developers require further guidance to enable greater transparency in the reporting of the reasons for discordant recommendations., (© 2023. The Author(s).)

Introduction: Increasing collaborative and integrated working between General practice (GP) and Community pharmacy (CP) is a key priority of the UK National Health Service and has been proposed as a solution to reducing health system fragmentation, improving synergies and coordination of care. However, there is limited understanding regarding how and under which circumstances collaborative and integrated working between GP and CP can be achieved in practice and how regulatory, organisational and systemic barriers can be overcome., Methods and Analysis: The aim of our review is to understand how, when and why working arrangements between GP and CP can provide the conditions necessary for optimal communication, decision-making, and collaborative and integrated working. A realist review approach will be used to synthesise the evidence to make sense of the complexities inherent in the working relationships between GP and CP. Our review will follow Pawson's five iterative stages: (1) finding existing theories; (2) searching for evidence (our main searches were conducted in April 2022); (3) article selection; (4) data extraction and (5) synthesising evidence and drawing conclusions. We will synthesise evidence from grey literature, qualitative, quantitative and mixed-methods research. The research team will work closely with key stakeholders and include patient and public involvement and engagement throughout the review process to refine the focus of the review and the programme theory. Collectively, our refined programme theory will explain how collaborative and integrated working between GP and CP works (or not), for whom, how and under which circumstances., Ethics and Dissemination: Formal ethical approval is not required for this review as it draws on secondary data from published articles and grey literature. Findings will be widely disseminated through: publication in peer-reviewed journals, seminars, international conference presentations, patients' association channels, social media, symposia and user-friendly summaries., Prospero Registration Number: CRD42022314280., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Older people's well-being can be bolstered by engaging with cultural activities and venues. They may be encouraged to try cultural offers by a link worker as part of social prescribing. However, the cultural sector, like all parts of life, was affected by the COVID-19 pandemic; this has had implications for cultural offers available to link workers. A study was conducted to explore the views and experiences of link workers in using the cultural sector within social prescribing, particularly for older people (aged 60+) during the pandemic. An online questionnaire was distributed to and completed by link workers in the UK. Data were analysed mainly using descriptive statistics. Open text responses were clustered into similar ideas to create key concepts. Useable responses were received from 148 link workers. They highlighted a general lack of interaction between link workers and the cultural sector about how the latter could support social prescribing. Results suggested that personal familiarity with cultural offers might prompt link workers to refer to them. Some respondents proposed that cultural offers were regarded as elitist, which deterred them from referring there. However, there was a general acknowledgement that the cultural sector could contribute to social prescribing. Link workers need to regard the cultural sector as accessible, appropriate, adequate, affordable and available before referring older people to cultural offers as part of social prescribing. Link workers may benefit from becoming more familiar with cultural sector staff and offers, including online resources, so they can then propose them to patients with confidence., (© 2022 The Authors. Health and Social Care in the Community published by John Wiley & Sons Ltd.)

Introduction: Clinical guideline development often involves a rigorous synthesis of evidence involving multidisciplinary stakeholders with different priorities and knowledge of evidence synthesis; this makes communicating findings complex. Summary formats are typically used to communicate the results of evidence syntheses; however, there is little consensus on which formats are most effective and acceptable for different stakeholders., Methods: This mixed-methods systematic review (MMSR) aimed to evaluate the effectiveness and acceptability (e.g. preferences and attitudes and preferences towards) of evidence synthesis summary formats for GDG members. We followed the PRISMA 2020 guideline and Joanna Briggs Institute Manual for Evidence Synthesis for MMSRs. We searched six databases (inception to April 20, 2021) for randomised controlled trials (RCTs), RCTs with a qualitative component, and qualitative studies. Screening, data extraction, and quality appraisal were performed in duplicate. Qualitative findings were synthesised using meta-aggregation, and quantitative findings are described narratively., Results: We identified 17,240 citations and screened 54 full-text articles, resulting in 22 eligible articles (20 unique studies): 4 articles reported the results of 5 RCTs, one of which also had a qualitative component. The other 18 articles discussed the results of 16 qualitative studies. Therefore, we had 5 trials and 17 qualitative studies to extract data from. Studies were geographically heterogeneous and included a variety of stakeholders and summary formats. All 5 RCTs assessed knowledge or understanding with 3 reporting improvement with newer formats. The qualitative analysis identified 6 categories of recommendations: 'presenting information', 'tailoring information' for end users, 'trust in producers and summary', 'knowledge required' to understand findings, 'quality of evidence', and properly 'contextualising information'. Across these categories, the synthesis resulted in 126 recommendations for practice. Nine recommendations were supported by both quantitative and qualitative evidence and 116 by only qualitative. A majority focused on how to present information (n = 64) and tailor content for different end users (n = 24)., Conclusions: This MMSR provides guidance on how to improve evidence summary structure and layout. This can be used by synthesis producers to better communicate to GDGs. Study findings will inform the co-creation of evidence summary format prototypes based on GDG member's needs. Trial registration The protocol for this project was previously published, and the project was preregistered on Open Science Framework (Clyne and Sharp, Evidence synthesis and translation of findings for national clinical guideline development: addressing the needs and preferences of guideline development groups, 2021; Sharp and Clyne, Evidence synthesis summary formats for decision-makers and Clinical Guideline Development Groups: A mixed-methods systematic review protocol, 2021)., (© 2022. The Author(s).)

Background: Tackling problematic polypharmacy requires tailoring the use of medicines to individual circumstances and may involve the process of deprescribing. Deprescribing can cause anxiety and concern for clinicians and patients. Tailoring medication decisions often entails beyond protocol decision-making, a complex process involving emotional and cognitive work for healthcare professionals and patients. We undertook realist review to highlight and understand the interactions between different factors involved in deprescribing and to develop a final programme theory that identifies and explains components of good practice that support a person-centred approach to deprescribing in older patients with multimorbidity and polypharmacy., Methods: The realist approach involves identifying underlying causal mechanisms and exploring how, and under what conditions they work. We conducted a search of electronic databases which were supplemented by citation checking and consultation with stakeholders to identify other key documents. The review followed the key steps outlined by Pawson et al. and followed the RAMESES standards for realist syntheses., Results: We included 119 included documents from which data were extracted to produce context-mechanism-outcome configurations (CMOCs) and a final programme theory. Our programme theory recognises that deprescribing is a complex intervention influenced by a multitude of factors. The components of our final programme theory include the following: a supportive infrastructure that provides clear guidance around professional responsibilities and that enables multidisciplinary working and continuity of care, consistent access to high-quality relevant patient contextual data, the need to support the creation of a shared explanation and understanding of the meaning and purpose of medicines and a trial and learn approach that provides space for monitoring and continuity. These components may support the development of trust which may be key to managing the uncertainty and in turn optimise outcomes. These components are summarised in the novel DExTruS framework., Conclusion: Our findings recognise the complex interpretive practice and decision-making involved in medication management and identify key components needed to support best practice. Our findings have implications for how we design medication review consultations, professional training and for patient records/data management. Our review also highlights the role that trust plays both as a central element of tailored prescribing and a potential outcome of good practice in this area., (© 2022. The Author(s).)

Background: Non-medical issues (e.g. loneliness, financial concerns, housing problems) can shape how people feel physically and psychologically. This has been emphasised during the Covid-19 pandemic, especially for older people. Social prescribing is proposed as a means of addressing non-medical issues, which can include drawing on support offered by the cultural sector., Method: A rapid realist review was conducted to explore how the cultural sector (in particular public/curated gardens, libraries and museums), as part of social prescribing, can support the holistic well-being of older people under conditions imposed by the pandemic. An initial programme theory was developed from our existing knowledge and discussions with cultural sector staff. It informed searches on databases and within the grey literature for relevant documents, which were screened against the review's inclusion criteria. Data were extracted from these documents to develop context-mechanism-outcome configurations (CMOCs). We used the CMOCs to refine our initial programme theory., Results: Data were extracted from 42 documents. CMOCs developed from these documents highlighted the importance of tailoring-shaping support available through the cultural sector to the needs and expectations of older people-through messaging, matching, monitoring and partnerships. Tailoring can help to secure benefits that older people may derive from engaging with a cultural offer-being distracted (absorbed in an activity) or psychologically held, making connections or transforming through self-growth. We explored the idea of tailoring in more detail by considering it in relation to Social Exchange Theory., Conclusions: Tailoring cultural offers to the variety of conditions and circumstances encountered in later life, and to changes in social circumstances (e.g. a global pandemic), is central to social prescribing for older people involving the cultural sector. Adaptations should be directed towards achieving key benefits for older people who have reported feeling lonely, anxious and unwell during the pandemic and recovery from it., (© 2022. The Author(s).)

Background: Most adults fail to achieve remission from common mental health conditions based on pharmacological treatment in primary care alone. There is no data synthesising the reasons. This review addresses this gap through a systematic review and thematic synthesis to understand adults' experiences using primary care for treatment-resistant mental health conditions (TRMHCs). We use the results to produce patient-driven recommendations for better support in primary care., Methods: Eight databases were searched from inception to December 2020 for qualitative studies reporting research on people's experience with TRMHCs in primary care. We included the following common mental health conditions defined by NICE: anxiety, depression, panic disorder, post-traumatic stress, and obsessive-compulsive disorder. Two reviewers independently screened studies. Eligible studies were analysed using an aggregative thematic synthesis., Results: Eleven studies of 4456 were eligible. From these eleven studies, 4 descriptive themes were developed to describe a cycle of care that people with TRMHCs experienced in primary care. In the first stage, people preferred to self-manage their mental health and reported barriers that prevented them from seeing a GP (e.g., stigma). People felt it necessary to see their GP only when reaching a crisis point. In the second stage, people were usually prescribed antidepressants, but were sceptical about any benefits they had to their mental health. In the third stage, people self-managed their mental health (e.g., by adjusting antidepressant dosage). The fourth stage described the reoccurrence of mental health and need to see a GP again. The high-order theme, 'breaking the cycle,' described how this cycle could be broken (e.g., continuity of care)., Conclusions: People with TRMHCs and GPs could break the cycle of care by having a conversation about what to do when antidepressants fail to work. This conversation could include replacing antidepressants with psychological interventions like talking therapy or mindfulness., (© 2022. The Author(s).)

Background: Current recommendations for people with irritable bowel syndrome (IBS) to partake in physical activity are based on low-level evidence, do not incorporate evidence from all available randomised controlled trials (RCTs) and provide little information regarding potential adverse effects., Objectives: To assess the benefits and harms of physical activity interventions in adults diagnosed with irritable bowel syndrome and to explore possible effect moderators including type, setting and nature of physical activity interventions., Search Methods: We searched nine electronic databases including CENTRAL, MEDLINE and Embase to 5 November 2021. We handsearched reference lists and sought unpublished studies through trial registries., Selection Criteria: We included RCTs involving adults (aged 18 years or older) diagnosed with IBS and conducted in any setting comparing a physical activity intervention with no intervention, usual care or wait-list control group or another physical activity intervention group and assessing a validated measure of symptoms, quality of life or bowel movement., Data Collection and Analysis: At least two review authors independently selected studies for inclusion, extracted study data, and performed risk of bias and GRADE assessments to assess the certainty of evidence. We pooled studies that evaluated similar outcomes using a random-effects meta-analysis, and synthesised data from other studies narratively., Main Results: We included 11 RCTs with data for 622 participants. Most (10/11) were set in high- or middle- to high-income countries, with five involving supervised physical activity, three unsupervised activity and three a mix of supervised and unsupervised activity. No trial was at low risk of bias. Four trials specified a minimally important difference for at least one assessed outcome measure. Data for 10 trials were obtained from published journal articles, with data for one obtained from an unpublished Masters degree thesis. Irritable bowel syndrome symptoms Six RCTs assessed the effectiveness of a physical activity intervention compared with usual care on global symptoms of IBS. Meta-analysis of five studies showed an observed improvement in reported symptoms following physical activity (standardised mean difference (SMD) -0.93, 95% confidence interval (CI) -1.44 to -0.42; 185 participants). We rated the certainty of evidence for this outcome as very low due to unclear and high risk of bias, inconsistency and imprecision from sparse data. This means physical activity may improve IBS symptoms but the evidence is very uncertain. The results of the remaining study supported the meta-analysis but were at unclear risk of bias and sample size was small. Two studies assessed the effectiveness of a yoga intervention compared with a walking intervention on global IBS symptoms. Meta-analysis of these two studies found no conclusive evidence of an effect of yoga compared with walking on IBS symptoms (SMD -1.16, 95% CI -3.93 to 1.62; 124 participants). We rated the certainty of evidence as very low, meaning the evidence is very uncertain about the effect of yoga interventions compared with walking interventions on IBS symptoms. Two studies assessed the effectiveness of a physical activity intervention (yoga) compared with medication. One reported no observed difference in global IBS symptoms, though CIs were wide, suggesting uncertainty in the observed estimates and risk of bias was high (MD -1.20, 95% CI -2.65 to 0.25; 21 participants). We excluded IBS symptom data for the remaining study as it used a non-validated method. One study compared a yoga intervention with a dietary intervention and reported an observed improvement in symptoms with both interventions but neither intervention was superior to the other. Quality of life Five RCTs assessed the impact of physical activity on self-reported quality of life compared with usual care. Meta-analysis of data from four studies found no improvement in quality of life following a physical activity intervention (SMD 1.17, 95% CI -0.30 to 2.64; 134 participants; very low certainty due to risk of bias, inconsistency and imprecision). We rated the certainty of evidence as very low, meaning the evidence is very uncertain about the effect of physical activity interventions on quality-of-life outcomes in people with IBS. One study assessed the impact on quality of life of a yoga intervention compared with walking and observed an improvement in the yoga group (MD 53.45, 95% CI 38.85 to 68.05; 97 participants ).  One study reported no observed difference in quality of life between a yoga and a dietary intervention. Abdominal pain Two trials assessed the impact of physical activity compared with usual care on reported abdominal pain. Meta-analysis found no improvement in abdominal pain with physical activity compared with usual care (SMD 0.01, 95% CI -0.48 to 0.50; 64 participants). We rated the certainty of the evidence as very low due to risk of bias and imprecision, meaning the evidence is very uncertain about the effect of physical activity interventions on abdominal pain in people with IBS. One study assessing the impact of a yoga intervention compared with walking advice reported no observed differences between groups on abdominal pain. One study comparing a yoga intervention with a dietary intervention found neither intervention had a more beneficial impact than the other and both interventions did not conclusively reduce abdominal pain. There was insufficient evidence to adequately assess adverse effects associated with physical activity due to a lack of reporting in trials. One study reported a musculoskeletal injury in a yoga intervention group but this did not result in withdrawal from the study., Authors' Conclusions: Findings from a small body of evidence suggest that physical activity comprising of yoga, treadmill exercise or support to increase physical activity may improve symptoms but not quality of life or abdominal pain in people diagnosed with IBS but we have little confidence in these conclusions due to the very low certainty of evidence. The numbers of reported adverse events were low and the certainty of these findings was very low for all comparisons, so no conclusions can be drawn. Discussions with patients considering physical activity as part of symptom management should address the uncertainty in the evidence to ensure fully informed decisions. If deemed sufficiently important to patients and healthcare providers, higher quality research is needed to enable more certain conclusions., (Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Introduction : Evidence syntheses, often in the form of systematic reviews, are essential for clinical guideline development and informing changes to health policies. However, clinical guideline development groups (CGDG) are multidisciplinary, and participants such as policymakers, healthcare professionals and patient representatives can face obstacles when trying to understand and use evidence synthesis findings. Summary formats to communicate the results of evidence syntheses have become increasingly common, but it is currently unclear which format is most effective for different stakeholders. This mixed-methods systematic review (MMSR) evaluates the effectiveness and acceptability of different evidence synthesis summary formats for CGDG members. Methods : This protocol follows guidance from the Joanna Briggs Institute on MMSRs and is reported according to the Preferred Reporting Items for Systematic Reviews (PRISMA)-P guideline. A comprehensive search of six databases will be performed with no language restrictions. Primary outcomes are those relating to the effectiveness and preferences for and attitudes towards the different summary formats. We will include qualitative research and randomised controlled trials. Two reviewers will perform title, abstract, and full-text screening. Independent double-extraction of study characteristics and critical appraisal items will be undertaken using a standardised form. We will use a convergent segregated approach to analyse quantitative and qualitative data separately; results will then be integrated. Discussion : The results of this systematic review will provide an overview of the effectiveness and acceptability of different summary formats for evidence synthesis findings. These findings can be helpful for those in or communicating to guideline development groups. The results can also inform the development and pilot-testing of summary formats for evidence summaries., Competing Interests: No competing interests were disclosed., (Copyright: © 2022 Sharp MK et al.)

Social prescribing is an approach that aims to improve health and well-being. It connects individuals to non-clinical services and supports that address social needs, such as those related to loneliness, housing instability and mental health. At the person level, social prescribing can give individuals the knowledge, skills, motivation and confidence to manage their own health and well-being. At the society level, it can facilitate greater collaboration across health, social, and community sectors to promote integrated care and move beyond the traditional biomedical model of health. While the term social prescribing was first popularised in the UK, this practice has become more prevalent and widely publicised internationally over the last decade. This paper aims to illuminate the ways social prescribing has been conceptualised and implemented across 17 countries in Europe, Asia, Australia and North America. We draw from the 'Beyond the Building Blocks' framework to describe the essential inputs for adopting social prescribing into policy and practice, related to service delivery; social determinants and household production of health; workforce; leadership and governance; financing, community organisations and societal partnerships; health technology; and information, learning and accountability. Cross-cutting lessons can inform country and regional efforts to tailor social prescribing models to best support local needs., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: There has been a recent trend towards creating larger primary care practices with the assumption that interdisciplinary teams can deliver improved and more cost-effective services to patients with better accessibility. Micro-teams have been proposed to mitigate some of the potential challenges with practice expansion, including continuity of care. We aim to review the available literature to improve understanding of how micro-teams are described and the opportunities which primary care micro-teams can provide for practice staff and patients and limitations to their introduction and implementation. Our review asks: how is micro-team implementation described? What are the experiences of healthcare professionals and patients concerning micro-teams in primary care? What are the reported implications of micro-teams for patient care?, Methods and Analysis: CINAHL, Cochrane Library, Embase, MEDLINE and Scopus will be searched for studies in English. Grey literature will be sourced from Google Scholar, government websites, CCG websites, general practice directives and strategies with advice from stakeholders. Included studies will give evidence regarding the implementation of micro-teams. Data will be synthesised using framework analysis. We will use iterative stakeholder and public and patient participation to embed the perspectives of those whom micro-teams could impact. Included studies will be quality assessed using the Mixed Methods Appraisal Tool. The quality assessment will not be used to exclude any evidence but rather to develop a narrative discussion evaluating included literature., Ethics and Dissemination: Ethical approval will not be necessary for this systematic review as there will only be a secondary analysis of data already available in scientific databases and the grey literature. This protocol has been submitted for registration to be made available on a review database (PROSPERO). Findings will be disseminated widely through peer-reviewed publication and in various media, for example, conferences, congresses or symposia., Prospero Registration Number: CRD42021225367., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The consumption of opioids has increased globally since the 1990s. Previous studies of global opioid consumption have concentrated on morphine alone or a subset of opioids, with a focus on cancer pain and palliative care. In this study, we have determined the global, regional, and national consumption of all controlled opioids, including anaesthetics, analgesics, antidiarrheals, opioid substitution therapies, and cough suppressants., Methods: We conducted a cross-sectional study using data from the International Narcotics Control Board (INCB). We calculated mean opioid consumption (mg/person) globally, regionally, and nationally for 2015-2017, where consumption refers to the total amount of controlled opioids distributed for medical purposes and excludes recreational use. We ranked countries by total consumption and quantified the types of opioids consumed globally., Results: Between 2015 and 2017, 90% of the world's population consumed only 11% of controlled opioids. An average of 32 mg/person was consumed annually, but this was not equally distributed across the world. Consumption was the highest in Germany (480 mg/person), followed by Iceland (428 mg/person), the United States (398 mg/person) and Canada (333 mg/person). Oxycodone (35%) was the most heavily consumed controlled opioid globally, followed by morphine (15.9%), methadone (15.8%) and tilidine (14%)., Conclusion: Large disparities persist in most of the world in accessing essential opioid medicines. Consumption patterns should continue to be monitored, and collaborative strategies should be developed to promote access and the appropriate prescribing of opioids in all countries and non-metropolitan territories., Competing Interests: Conflict of interest: The author(s) declared the following potential conflicts of interest with respect to the research, authorship and/or publication of this article: G.C.R. was financially supported by the National Institute for Health Research (NIHR) School for Primary Care Research (SPCR), the Naji Foundation and the Rotary Foundation to study for a Doctor of Philosophy (2017–2020) but no longer has any financial COIs. G.C.R. is an Associate Editor of BMJ Evidence-Based Medicine. J.K.A. has published articles and edited textbooks on adverse drug reactions and interactions and has often given medicolegal advice, including appearances as an expert witness in coroners’ courts, often dealing with the adverse effects of opioids. K.R.M. has received funding to conduct research from the NIHR and the Royal College of General Practitioners (RCGP) to conduct independent research. C.H. is an NIHR Senior Investigator and has received expenses and fees for his media work, received expenses from the WHO and FDA, and holds grant funding from the NIHR SPCR and the NIHR SPCR Evidence Synthesis Working Group (Project 380), the NIHR BRC Oxford and the WHO. On occasion, C.H. receives expenses for teaching EBM and is also paid for his GP work in National Health Service (NHS) out of hours (contract with the Oxford Health NHS Foundation Trust). C.H. is the Director of the CEBM. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care., (© The British Pain Society 2021.)

Volunteering for an organisation, charity or group enables people to make connections with others and to be involved in interesting, worthwhile and/or enjoyable pursuits. Engaging in volunteering can form part of a social prescribing action plan developed between a patient and link worker. Greater understanding of the processes through which volunteering can improve people's well-being as part of social prescribing will help to support link workers in their role. We conducted a best-fit framework synthesis of qualitative literature on volunteering and well-being. Our search of eight electronic databases, complemented by a Google search, conducted in June 2020, resulted in the location of 2210 potentially relevant references. After screening, 335 papers were read in full and 54 drawn upon within the review. They were published between 1993 and 2020. We used the New Economics Foundation's Five Ways to Well-Being model to guide data extraction and synthesis. From this, we developed a conceptual framework that highlights how volunteering can contribute to identity validation and modification leading to the establishment of an acceptable sense of self. Our findings have implications for: (a) the use of volunteering as part of a link worker's toolkit as they seek to support people with varying psychosocial needs and (b) requirements of organisations accepting referrals to volunteering as part of social prescribing., (© 2021 John Wiley & Sons Ltd.)

Background: Schizophrenia and bipolar disorder are severe mental illnesses which are highly prevalent worldwide. Risperidone and Paliperidone are treatments for either illnesses, but their efficacy compared to other antipsychotics and growing reports of hormonal imbalances continue to raise concerns. As existing evidence on both antipsychotics are solely based on aggregate data, we aimed to assess the benefits and harms of Risperidone and Paliperidone in the treatment of patients with schizophrenia or bipolar disorder, using individual participant data (IPD), clinical study reports (CSRs) and publicly available sources (journal publications and trial registries)., Methods: We searched MEDLINE, Central, EMBASE and PsycINFO until December 2020 for randomised placebo-controlled trials of Risperidone, Paliperidone or Paliperidone palmitate in patients with schizophrenia or bipolar disorder. We obtained IPD and CSRs from the Yale University Open Data Access project. The primary outcome Positive and Negative Syndrome Scale (PANSS) score was analysed using one-stage IPD meta-analysis. Random-effect meta-analysis of harm outcomes involved methods for coping with rare events. Effect-sizes were compared across all available data sources using the ratio of means or relative risk. We registered our review on PROSPERO, CRD42019140556., Results: Of the 35 studies, IPD meta-analysis involving 22 (63%) studies showed a significant clinical reduction in the PANSS in patients receiving Risperidone (mean difference - 5.83, 95% CI - 10.79 to - 0.87, I 2 = 8.5%, n = 4 studies, 1131 participants), Paliperidone (- 6.01, 95% CI - 8.7 to - 3.32, I 2 = 4.3%, n = 13, 3821) and Paliperidone palmitate (- 7.89, 95% CI - 12.1 to - 3.69, I 2 = 2.9%, n = 5, 2209). CSRs reported nearly two times more adverse events (4434 vs. 2296 publication, relative difference (RD) = 1.93, 95% CI 1.86 to 2.00) and almost 8 times more serious adverse events (650 vs. 82; RD = 7.93, 95% CI 6.32 to 9.95) than the journal publications. Meta-analyses of individual harms from CSRs revealed a significant increased risk among several outcomes including extrapyramidal disorder, tardive dyskinesia and increased weight. But the ratio of relative risk between the different data sources was not significant. Three treatment-related gynecomastia events occurred, and these were considered mild to moderate in severity., Conclusion: IPD meta-analysis conclude that Risperidone and Paliperidone antipsychotics had a small beneficial effect on reducing PANSS score over 9 weeks, which is more conservative than estimates from reviews based on journal publications. CSRs also contained significantly more data on harms that were unavailable in journal publications or trial registries. Sharing of IPD and CSRs are necessary when performing meta-analysis on the efficacy and safety of antipsychotics., (© 2021. The Author(s).)

Background: Unsolicited feedback can solicit changes in prescribing., Objectives: Determine whether a low-cost intervention increases clinicians' engagement with data, and changes prescribing; with or without behavioural science techniques., Methods: Randomized trial (ISRCTN86418238). The highest prescribing practices in England for broad-spectrum antibiotics were allocated to: feedback with behavioural impact optimization; plain feedback; or no intervention. Feedback was sent monthly for 3 months by letter, fax and email. Each included a link to a prescribing dashboard. The primary outcomes were dashboard usage and change in prescribing., Results: A total of 1401 practices were randomized: 356 behavioural optimization, 347 plain feedback, and 698 control. For the primary engagement outcome, more intervention practices had their dashboards viewed compared with controls [65.7% versus 55.9%; RD 9.8%, 95% confidence intervals (CIs): 4.76% to 14.9%, P < 0.001]. More plain feedback practices had their dashboard viewed than behavioural feedback practices (69.1% versus 62.4%); but not meeting the P < 0.05 threshold (6.8%, 95% CI: -0.19% to 13.8%, P = 0.069). For the primary prescribing outcome, intervention practices possibly reduced broad-spectrum prescribing to a greater extent than controls (1.42% versus 1.12%); but again not meeting the P < 0.05 threshold (coefficient -0.31%, CI: -0.7% to 0.1%, P = 0.104). The behavioural impact group reduced broad-spectrum prescribing to a greater extent than plain feedback practices (1.63% versus 1.20%; coefficient 0.41%, CI: 0.007% to 0.8%, P = 0.046). No harms were detected., Conclusions: Unsolicited feedback increased practices' engagement with data, with possible slightly reduced antibiotic prescribing (P = 0.104). Behavioural science techniques gave greater prescribing effects. The modest effects on prescribing may reflect saturation from similar initiatives on antibiotic prescribing., Clinical Trial Registration: ISRCTN86418238., (© The Author(s) 2021. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Introduction : Evidence syntheses, often in the form of systematic reviews, are essential for clinical guideline development and informing changes to health policies. However, clinical guideline development groups (CGDG) are multidisciplinary, and participants such as policymakers, healthcare professionals and patient representatives can face obstacles when trying to understand and use evidence synthesis findings. Summary formats to communicate the results of evidence syntheses have become increasingly common, but it is currently unclear which format is most effective for different stakeholders. This mixed-methods systematic review (MMSR) evaluates the effectiveness and acceptability of different evidence synthesis summary formats for CGDG members. Methods : This protocol follows guidance from the Joanna Briggs Institute on MMSRs and is reported according to the Preferred Reporting Items for Systematic Reviews (PRISMA)-P guideline. A comprehensive search of six databases will be performed with no language restrictions. Primary outcomes are those relating to the effectiveness and preferences for and attitudes towards the different summary formats. We will include qualitative research and randomised controlled trials. Two reviewers will perform title, abstract, and full-text screening. Independent double-extraction of study characteristics and critical appraisal items will be undertaken using a standardised form. We will use a convergent segregated approach to analyse quantitative and qualitative data separately; results will then be integrated. Discussion : The results of this systematic review will provide an overview of the effectiveness and acceptability of different summary formats for evidence synthesis findings. These findings can be helpful for those in or communicating to guideline development groups. The results can also inform the development and pilot-testing of summary formats for evidence summaries., Competing Interests: No competing interests were disclosed., (Copyright: © 2021 Sharp MK et al.)

Background: Since 2002, paramedics have been working in primary care within the United Kingdom (UK), a transition also mirrored within Australia, Canada and the USA. Recent recommendations to improve UK NHS workforce capacities have led to a major push to increase the numbers of paramedics recruited into primary care. However, gaps exist in the evidence base regarding how and why these changes would work, for whom, in what context and to what extent. To understand the ways in which paramedics impact (or not) the primary care workforce, we conducted a realist review., Methods: A realist approach aims to provide causal explanations through the generation and articulation of contexts, mechanisms and outcomes. Our search of electronic databases was supplemented with Google and citation checking to locate grey literature including news items and workforce reports. Included documents were from the UK, Australia, Canada and the Americas-countries within which the paramedic role within primary care is well established., Results: Our searches resulted in 205 included documents, from which data were extracted to produce context-mechanism-outcome configurations (CMOCs) within a final programme theory. Our results outline that paramedics are more likely to be effective in contributing to primary care workforces when they are supported to expand their existing role through formal education and clinical supervision. We also found that unless paramedics were fully integrated into primary care services, they did not experience the socialisation needed to build trusting relationships with patients or physicians. Indeed, for patients to accept paramedics in primary care, their role and its implications for their care should be outlined by a trusted source., Conclusions: Our realist review highlights the complexity surrounding the introduction of paramedics into primary care roles. As well as offering an insight into understanding the paramedic professional identity, we also discuss the range of expectations this professional group will face in the transition to primary care. These expectations come from patients, general practitioners (family physicians) and paramedics themselves. This review is the first to offer insight into understanding the impact paramedics may have on the international primary care workforce and shaping how they might be optimally deployed.

Background: Polypharmacy is inevitable and appropriate for many conditions, but in some cases, it can be problematic resulting in an increased risk of harm and reduced quality of life. There has been an increasing interest to reduce cardioprotective medications in older adults to potentially reduce the risk of harm due to treatment; however, there is no evidence on safety and efficacy to support this practice currently. This paper describes a protocol for a systematic review on the safety and efficacy of reducing cardioprotective medication in older populations., Methods: MEDLINE (PubMed), Embase (Ovid), and CENTRAL (Cochrane Central Register of Controlled Trials) will be searched from their inception onwards for relevant studies. Randomised controlled trials and non-randomised studies on interventions (prospective, retrospective cohort, case-control) conducted in older adults (75 years or older) examining reduction of cardioprotective medications will be included. The primary outcome of this study will be all-cause hospitalisation. Secondary outcome variables of interest are all-cause hospitalisation, mortality, quality of life, serious adverse events, major adverse cardiovascular events, falls, fractures, cognitive functioning, bleeding events, renal functioning, medication burden, drug reinstatement, time-in-hospital, and frailty status. Two reviewers will independently screen all citations, full-text articles, and extract data. Confidence in cumulative evidence will be assessed using the GRADE approach; the risk of bias will be assessed by the RoB-II tool for randomised controlled studies and ROBINS-I for non-randomised studies. Where sufficient data are available, we will conduct a random effects meta-analysis by combining the outcomes of the included studies. Sub-group analysis and meta-regression are planned to assess the potential harms and risks of different drug classes and the impacts in different patient populations (e.g. sex, cognitive status, renal status, and age)., Discussion: The study will be a comprehensive review on all published articles identified using our search strategy on the safety and efficacy of cardioprotective medication reduction in the older population. The findings will be crucial to inform clinicians on potential health outcomes of reducing cardiovascular medication in the elderly., Systematic Review Registration: PROSPERO CRD42020208223.

Competing Interests: Competing interests: KRM and JKA were associate editors of BMJ Evidence Medicine at the time of submission.

Competing Interests: Competing interests: KRM and JKA were Associate Editors of BMJ Evidence Medicine at the time of submission.

Competing Interests: Competing interests: KRM and JA were associate editors of BMJ Evidence Medicine at the time of submission.

Competing Interests: Competing interests: KRM and JA were Associate Editors of BMJ Evidence Medicine at the time of submission.

Competing Interests: Competing interests: CH is supported by the NIHR School for Primary Care Research. Evidence Synthesis Working group (NIHR SPCR ESWG project 390). CH isalso supported by the NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, an NIHR senior investigator and editor-in-chief of BMJ Evidence-Based Medicine. JO is an NIH Postdoctoral Fellow at Stanford University. He is an associate editor at BMJ Evidence-Based Medicine. KRM is supported by the NIHR School for Primary Care ResearchEvidence Synthesis Working group (NIHR SPCR ESWG project 390).