Primary care micro-teams: an international systematic review of patient and healthcare professional perspectives.

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.

#TreatmentResistantDepression: A qualitative content analysis of Tweets about difficult-to-treat depression.

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.

Strong recommendations from low certainty evidence: a cross-sectional analysis of a suite of national guidelines.

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.

Understanding and Improving Older People's Well-Being through Social Prescribing Involving the Cultural Sector: Interviews from a Realist Evaluation.

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.

The effectiveness and acceptability of evidence synthesis summary formats for clinical guideline development groups: a mixed-methods systematic review.

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).

Optimising a person-centred approach to stopping medicines in older people with multimorbidity and polypharmacy using the DExTruS framework: a realist review.

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.

Tailoring cultural offers to meet the needs of older people during uncertain times: a rapid realist review.

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.

Experiences of treatment-resistant mental health conditions in primary care: a systematic review and thematic synthesis.

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.

Social prescribing for older people and the role of the cultural sector during the COVID-19 pandemic: What are link workers' views and experiences?

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.

Physical activity for treatment of irritable bowel syndrome.

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.

Global developments in social prescribing.

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.

Global, regional, and national consumption of controlled opioids: a cross-sectional study of 214 countries and non-metropolitan territories.

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.

The role of volunteering in supporting well-being - What might this mean for social prescribing? A best-fit framework synthesis of qualitative research.

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.

Benefits and harms of Risperidone and Paliperidone for treatment of patients with schizophrenia or bipolar disorder: a meta-analysis involving individual participant data and clinical study reports.

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, I2 = 8.5%, n = 4 studies, 1131 participants), Paliperidone (- 6.01, 95% CI - 8.7 to - 3.32, I2 = 4.3%, n = 13, 3821) and Paliperidone palmitate (- 7.89, 95% CI - 12.1 to - 3.69, I2 = 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.

Understanding the role of the paramedic in primary care: a realist review.

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.

The health impacts of preventive cardiovascular medication reduction on older populations: protocol for a systematic review and meta-analysis.

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.

Evaluating the impact of a very low-cost intervention to increase practices' engagement with data and change prescribing behaviour: a randomized trial in English primary care.

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.