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Supporting bereavement and complicated grief in primary care: a realist review

Background Bereavement can have significant impacts on physical and mental health, and a minority of people experience complicated and prolonged grief responses. Primary care is ideally situated to offer bereavement care, yet UK provision remains variable and practitioners feel uncertain how best to support bereaved patients. Aim To identify what works, how, and for whom, in the management of complicated grief in primary care. Design & setting A review of evidence on the management of complicated grief and bereavement in UK primary care settings. Method A realist approach was taken which aims to provide causal explanations through the generation and articulation of contexts, mechanisms, and outcomes. Results Forty-two articles were included. Evidence on the primary care management of complicated or prolonged grief was limited. GPs and nurses view bereavement support as part of their role, yet experience uncertainty over the appropriate extent of their involvement. Patients and clinicians often have differing views on the role of primary care in bereavement. Training in bereavement, local systems for reporting deaths, practitioner time and resources can assist or hinder bereavement care provision. Practitioners find bereavement care can be emotionally challenging. Understanding patients’ needs can encourage a proactive response and help identify appropriate support. Conclusion Bereavement care in primary care remains variable and practitioners feel unprepared to provide appropriate bereavement care. Patients at higher risk of complicated or prolonged grief may fail to receive the support they need from primary care. Further research is required to address the potential unmet needs of bereaved patients.

‘A silent epidemic of grief’: a survey of bereavement care provision in the UK and Ireland during the COVID-19 pandemic

Objectives To investigate the experiences and views of practitioners in the UK and Ireland concerning changes in bereavement care during the COVID-19 pandemic. Design Online survey using a snowball sampling approach. Setting Practitioners working in hospitals, hospices, care homes and community settings across the UK and Ireland. Participants Health and social care professionals involved in bereavement support. Interventions Brief online survey distributed widely across health and social care organisations. Results 805 respondents working in hospice, community, and hospital settings across the UK and Ireland completed the survey between 3 August and 4 September 2020. Changes to bereavement care practice were reported in: the use of telephone, video and other forms of remote support (90%); supporting people bereaved from non-COVID conditions (76%), from COVID-19 (65%) and people bereaved before the pandemic (61%); funeral arrangements (61%); identifying bereaved people who might need support (56%); managing complex forms of grief (48%) and access to specialist services (41%). Free-text responses demonstrated the complexities and scale of the impact on health and social care services, practitioners and their relationships with bereaved families, and on bereaved people. Conclusions The pandemic has created major challenges for the support of bereaved people: increased needs for bereavement care, transition to remote forms of support and the stresses experienced by practitioners, among others. The extent to which services are able to adapt, meet the escalating level of need and help to prevent a ‘tsunami of grief’ remains to be seen. The pandemic has highlighted the need for bereavement care to be considered an integral part of health and social care provision.

Viral cultures for COVID-19 infectious potential assessment – a systematic review

Objective: to review the evidence from studies relating SARS-CoV-2 culture with the results of reverse transcriptase polymerase chain reaction (RT-PCR) and other variables which may influence the interpretation of the test, such as time from symptom onset Methods: We searched LitCovid, medRxiv, Google Scholar and the WHO Covid-19 database for Covid-19 to 10 September 2020. We included studies attempting to culture or observe SARS-CoV-2 in specimens with RT-PCR positivity. Studies were dual extracted and the data summarised narratively by specimen type. Where necessary we contacted corresponding authors of included papers for additional information. We assessed quality using a modified QUADAS 2 risk of bias tool. Results: We included 29 studies reporting attempts at culturing, or observing tissue infection by, SARS-CoV-2 in sputum, nasopharyngeal or oropharyngeal, urine, stool, blood and environmental specimens. The quality of the studies was moderate with lack of standardised reporting. The data suggest a relationship between the time from onset of symptom to the timing of the specimen test, cycle threshold (Ct) and symptom severity. Twelve studies reported that Ct values were significantly lower and log copies higher in specimens producing live virus culture. Two studies reported the odds of live virus culture reduced by approximately 33% for every one unit increase in Ct. Six of eight studies reported detectable RNA for longer than 14 days but infectious potential declined after day 8 even among cases with ongoing high viral loads. Four studies reported viral culture from stool specimens. Conclusion: Complete live viruses are necessary for transmission, not the fragments identified by PCR. Prospective routine testing of reference and culture specimens and their relationship to symptoms, signs and patient co-factors should be used to define the reliability of PCR for assessing infectious potential. Those with high cycle threshold are unlikely to have infectious potential.

Addressing and Overcoming Barriers to E-Cigarette Use for Smoking Cessation in Pregnancy: A Qualitative Study

E-cigarettes may have a role in supporting pregnant women who would otherwise smoke to stop smoking. The study aimed to understand pregnant women’s vaping experiences, in particular how vaping to stop smoking is facilitated and how barriers to this are overcome. We conducted semi structured telephone interviews (n = 15) with pregnant or postpartum women who vaped during pregnancy, either exclusively (n = 10) or dual-used (n = 5) (smoked and vaped). Thematic analysis was used to analyse the interviews. Two themes emerged. First, ‘facilitating beliefs’: inherent beliefs that helped women overcome barriers to vaping. These included understanding the relative safety of vaping and economic gains compared with smoking and pregnancy being a motivator to stop smoking. Second, ‘becoming a confident vaper’: accumulating sufficient skill and confidence to comfortably vape. This included experimentation with e-cigarettes to ensure nicotine dependence and sensory needs were met. Seeking social support and employing strategies to address social stigma were also important. Positive beliefs about vaping and becoming proficient at vaping were viewed as ways to overcome barriers to vaping. The theoretical domain framework informed intervention recommendations to assist pregnant smokers who have tried but cannot stop smoking to switch to vaping.

Clinical prediction models to predict the risk of multiple binary outcomes: a comparison of approaches

Clinical prediction models (CPMs) can predict clinically relevant outcomes or events. Typically, prognostic CPMs are derived to predict the risk of a single future outcome. However, there are many medical applications where two or more outcomes are of interest, meaning this should be more widely reflected in CPMs so they can accurately estimate the joint risk of multiple outcomes simultaneously. A potentially naïve approach to multi‐outcome risk prediction is to derive a CPM for each outcome separately, then multiply the predicted risks. This approach is only valid if the outcomes are conditionally independent given the covariates, and it fails to exploit the potential relationships between the outcomes. This paper outlines several approaches that could be used to develop CPMs for multiple binary outcomes. We consider four methods, ranging in complexity and conditional independence assumptions: namely, probabilistic classifier chain, multinomial logistic regression, multivariate logistic regression, and a Bayesian probit model. These are compared with methods that rely on conditional independence: separate univariate CPMs and stacked regression. Employing a simulation study and real‐world example, we illustrate that CPMs for joint risk prediction of multiple outcomes should only be derived using methods that model the residual correlation between outcomes. In such a situation, our results suggest that probabilistic classification chains, multinomial logistic regression or the Bayesian probit model are all appropriate choices. We call into question the development of CPMs for each outcome in isolation when multiple correlated or structurally related outcomes are of interest and recommend more multivariate approaches to risk prediction.

Fundamental statistical methods for prognosis research

Association between antihypertensive treatment and adverse events: systematic review and meta-analysis

Objective: To examine the association between antihypertensive treatment and specific adverse events. Design: Systematic review and meta-analysis. Eligibility criteria: Randomised controlled trials of adults receiving antihypertensives compared with placebo or no treatment, more antihypertensive drugs compared with fewer antihypertensive drugs, or higher blood pressure targets compared with lower targets. To avoid small early phase trials, studies were required to have at least 650 patient years of follow-up. Information sources: Searches were conducted in Embase, Medline, CENTRAL, and the Science Citation Index databases from inception until 14 April 2020. Main outcome measures: The primary outcome was falls during trial follow-up. Secondary outcomes were acute kidney injury, fractures, gout, hyperkalaemia, hypokalaemia, hypotension, and syncope. Additional outcomes related to death and major cardiovascular events were extracted. Risk of bias was assessed using the Cochrane risk of bias tool, and random effects meta-analysis was used to pool rate ratios, odds ratios, and hazard ratios across studies, allowing for between study heterogeneity (τ2). Results: Of 15 023 articles screened for inclusion, 58 randomised controlled trials were identified, including 280 638 participants followed up for a median of 3 (interquartile range 2-4) years. Most of the trials (n=40, 69%) had a low risk of bias. Among seven trials reporting data for falls, no evidence was found of an association with antihypertensive treatment (summary risk ratio 1.05, 95% confidence interval 0.89 to 1.24, τ2=0.009). Antihypertensives were associated with an increased risk of acute kidney injury (1.18, 95% confidence interval 1.01 to 1.39, τ2=0.037, n=15), hyperkalaemia (1.89, 1.56 to 2.30, τ2=0.122, n=26), hypotension (1.97, 1.67 to 2.32, τ2=0.132, n=35), and syncope (1.28, 1.03 to 1.59, τ2=0.050, n=16). The heterogeneity between studies assessing acute kidney injury and hyperkalaemia events was reduced when focusing on drugs that affect the renin angiotensin-aldosterone system. Results were robust to sensitivity analyses focusing on adverse events leading to withdrawal from each trial. Antihypertensive treatment was associated with a reduced risk of all cause mortality, cardiovascular death, and stroke, but not of myocardial infarction. Conclusions: This meta-analysis found no evidence to suggest that antihypertensive treatment is associated with falls but found evidence of an association with mild (hyperkalaemia, hypotension) and severe adverse events (acute kidney injury, syncope). These data could be used to inform shared decision making between doctors and patients about initiation and continuation of antihypertensive treatment, especially in patients at high risk of harm because of previous adverse events or poor renal function.

Calculating the sample size required for developing a clinical prediction model

Clinical prediction models aim to predict outcomes in individuals, to inform diagnosis or prognosis in healthcare. Hundreds of prediction models are published in the medical literature each year, yet many are developed using a dataset that is too small for the total number of participants or outcome events. This leads to inaccurate predictions and consequently incorrect healthcare decisions for some individuals. In this article, the authors provide guidance on how to calculate the sample size required to develop a clinical prediction model.

External validation of prognostic models predicting pre-eclampsia: individual participant data meta-analysis

Background Pre-eclampsia is a leading cause of maternal and perinatal mortality and morbidity. Early identification of women at risk during pregnancy is required to plan management. Although there are many published prediction models for pre-eclampsia, few have been validated in external data. Our objective was to externally validate published prediction models for pre-eclampsia using individual participant data (IPD) from UK studies, to evaluate whether any of the models can accurately predict the condition when used within the UK healthcare setting. Methods IPD from 11 UK cohort studies (217,415 pregnant women) within the International Prediction of Pregnancy Complications (IPPIC) pre-eclampsia network contributed to external validation of published prediction models, identified by systematic review. Cohorts that measured all predictor variables in at least one of the identified models and reported pre-eclampsia as an outcome were included for validation. We reported the model predictive performance as discrimination (C-statistic), calibration (calibration plots, calibration slope, calibration-in-the-large), and net benefit. Performance measures were estimated separately in each available study and then, where possible, combined across studies in a random-effects meta-analysis. Results Of 131 published models, 67 provided the full model equation and 24 could be validated in 11 UK cohorts. Most of the models showed modest discrimination with summary C-statistics between 0.6 and 0.7. The calibration of the predicted compared to observed risk was generally poor for most models with observed calibration slopes less than 1, indicating that predictions were generally too extreme, although confidence intervals were wide. There was large between-study heterogeneity in each model’s calibration-in-the-large, suggesting poor calibration of the predicted overall risk across populations. In a subset of models, the net benefit of using the models to inform clinical decisions appeared small and limited to probability thresholds between 5 and 7%. Conclusions The evaluated models had modest predictive performance, with key limitations such as poor calibration (likely due to overfitting in the original development datasets), substantial heterogeneity, and small net benefit across settings. The evidence to support the use of these prediction models for pre-eclampsia in clinical decision-making is limited. Any models that we could not validate should be examined in terms of their predictive performance, net benefit, and heterogeneity across multiple UK settings before consideration for use in practice.

Mental health in the UK during the COVID-19 pandemic: cross-sectional analyses from a community cohort study

Objectives Previous pandemics have resulted in significant consequences for mental health. Here, we report the mental health sequelae of the COVID-19 pandemic in a UK cohort and examine modifiable and non-modifiable explanatory factors associated with mental health outcomes. We focus on the first wave of data collection, which examined short-term consequences for mental health, as reported during the first 4–6 weeks of social distancing measures being introduced. Design Cross-sectional online survey. Setting Community cohort study. Participants N=3097 adults aged ≥18 years were recruited through a mainstream and social media campaign between 3 April 2020 and 30 April 2020. The cohort was predominantly female (n=2618); mean age 44 years; 10% (n=296) from minority ethnic groups; 50% (n=1559) described themselves as key workers and 20% (n=649) identified as having clinical risk factors putting them at increased risk of COVID-19. Main outcome measures Depression, anxiety and stress scores. Results Mean scores for depression (Embedded Image =7.69, SD=6.0), stress (Embedded Image =6.48, SD=3.3) and anxiety (Embedded Image = 6.48, SD=3.3) significantly exceeded population norms (all p<0.0001). Analysis of non-modifiable factors hypothesised to be associated with mental health outcomes indicated that being younger, female and in a recognised COVID-19 risk group were associated with increased stress, anxiety and depression, with the final multivariable models accounting for 7%–14% of variance. When adding modifiable factors, significant independent effects emerged for positive mood, perceived loneliness and worry about getting COVID-19 for all outcomes, with the final multivariable models accounting for 54%–57% of total variance. Conclusions Increased psychological morbidity was evident in this UK sample and found to be more common in younger people, women and in individuals who identified as being in recognised COVID-19 risk groups. Public health and mental health interventions able to ameliorate perceptions of risk of COVID-19, worry about COVID-19 loneliness and boost positive mood may be effective.

How do people who use drugs experience treatment? A qualitative analysis of views about opioid substitution treatment in primary care (iCARE study)

Objective: To understand the most significant aspects of care experienced by people in opioid substitution treatment (OST) in primary care settings. Design: Semistructured individual interviews were conducted, following the critical incidents technique. Interview transcripts were analysed following a thematic analysis approach. Participants: Adults aged 18 years or older, receiving OST in UK-based primary care services. Results: Twenty-four people in OST were interviewed between January and March 2019. Participants reported several aspects which were significant for their treatment, when engaging with the primary care service. These were grouped into 10 major themes: (1) humanised care; (2) individual bond/connection with the professional; (3) professionals’ experience and knowledge; (4) having holistic care; (5) familiarity; (6) professionals’ commitment and availability to help; (7) anonymity; (8) location; (9) collaborative teamwork; and (10) flexibility and changes around the treatment plan. Conclusions: This study included first-hand accounts of people who use drugs about what supports them in their recovery journey. The key lessons learnt from our findings indicate that people who use drugs value receiving treatment in humanised and destigmatised environments. We also learnt that a good relationship with primary care professionals supports their recovery journey, and that treatment plans should be flexible, tailor-made and collaboratively designed with patients.

GPs’ and patients’ views on the value of diagnosing anxiety disorders in primary care: a qualitative interview study

Background: In the UK between 1998 and 2008, GPs’ recording of anxiety symptoms increased, but their recording of anxiety disorders decreased. The reason for this decline is not clear, nor are the treatment implications for primary care patients. Aim: To understand GPs’ and patients’ views on the value of diagnosing anxiety disorders in primary care. Design and Setting: In-depth interviews were conducted with 15 GPs and 20 patients, purposively sampled from GP practices in Bristol and the surrounding areas. Method: Interviews were held either in person or by telephone. A topic guide was used to ensure consistency across the interviews. The interviews were audio-recorded, transcribed verbatim and analysed thematically. Results: GPs reported preferring to use symptom rather than diagnostic codes in order to avoid assigning potentially stigmatising labels, and because they felt diagnostic codes could encourage some patients to adopt a ‘sick-role’. In addition, their decision to use a diagnostic code depended on symptom severity and chronicity, and these were hard to establish in a time-limited clinical consultation. In contrast, patients commented that receiving a diagnosis helped them to understand their symptoms, and encouraged them to engage with treatment. Conclusion: GPs may be reluctant to diagnose an anxiety disorder, but patients can find a diagnosis helpful in terms of understanding their symptoms and the need for treatment. As limited consultation time can discourage discussions between GPs and patients, follow up appointments and continuity of care may be particularly important for the management of anxiety in primary care.

Contribution of paramedics in primary and urgent care: a systematic review

Background: Within the UK, there are now opportunities for paramedics to work across a variety of healthcare settings away from their traditional ambulance service employer, with many opting to move into primary care. Aim: To provide an overview of the types of clinical roles paramedics are undertaking in primary and urgent care settings within the UK. Design and setting: A systematic review. Method: Searches were conducted of MEDLINE, CINAHL, Embase, the National Institute for Health and Care Excellence, the Journal of Paramedic Practice, and the Cochrane Database from January 2004 to March 2019 for papers detailing the role, scope of practice, clinician and patient satisfaction, and costs of paramedics in primary and urgent care settings. Free-text keywords and subject headings focused on two key concepts: paramedic and general practice/primary care. Results: In total, 6765 references were screened by title and/or abstract. After full-text review, 24 studies were included. Key findings focused on the description of the clinical role, the clinical work environment, the contribution of paramedics to the primary care workforce, the clinical activities they undertook, patient satisfaction, and education and training for paramedics moving from the ambulance service into primary care. Conclusion: Current published research identifies that the role of the paramedic working in primary and urgent care is being advocated and implemented across the UK; however, there is insufficient detail regarding the clinical contribution of paramedics in these clinical settings. More research needs to be done to determine how, why, and in what context paramedics are now working in primary and urgent care, and what their overall contribution is to the primary care workforce.

Implementation of remote consulting in UK primary care following the COVID-19 pandemic: a mixed-methods longitudinal study

Background: To reduce contagion of COVID-19, in March 2020 UK general practices implemented predominantly remote consulting via telephone, video, or online consultation platforms. Aim: To investigate the rapid implementation of remote consulting and explore impact over the initial months of the COVID-19 pandemic. Design and setting: Mixed-methods study in 21 general practices in Bristol, North Somerset and South Gloucestershire. Method: Longitudinal observational quantitative analysis compared volume and type of consultation in April to July 2020 with April to July 2019. Negative binomial models were used to identify if changes differed among different groups of patients. Qualitative data from 87 longitudinal interviews with practice staff in four rounds investigated practices’ experience of the move to remote consulting, challenges faced, and solutions. A thematic analysis utilised Normalisation Process Theory. Results: There was universal consensus that remote consulting was necessary. This drove a rapid change to 90% remote GP consulting (46% for nurses) by April 2020. Consultation rates reduced in April to July 2020 compared to 2019; GPs and nurses maintained a focus on older patients, shielding patients, and patients with poor mental health. Telephone consulting was sufficient for many patient problems, video consulting was used more rarely, and was less essential as lockdown eased. SMS-messaging increased more than three-fold. GPs were concerned about increased clinical risk and some had difficulties setting thresholds for seeing patients face-to-face as lockdown eased. Conclusion: The shift to remote consulting was successful and a focus maintained on vulnerable patients. It was driven by the imperative to reduce contagion and may have risks; post-pandemic, the model will need adjustment.

Barriers to postpartum diabetes screening: a qualitative synthesis of clinicians’ views

Background: Gestational diabetes (GDM) is an important risk factor for developing type 2 diabetes (T2DM) later in life. Postpartum screening provides an opportunity for early detection and management of T2DM, but uptake is poor. Aim: To explore barriers to screening from clinicians’ perspectives to guide future interventions to increase uptake. Design and Setting: Systematic review and qualitative synthesis. Method: We assessed qualitative studies included in a previous review, then searched five electronic databases from 2013 to May 2019 for qualitative studies reporting clinicians’ perspectives on postpartum glucose screening after GDM. Study quality was assessed against the Critical Appraisal Skills Programmes checklist. Qualitative data from the studies were analysed using thematic synthesis. Results: We included nine studies, containing views from 187 clinicians from both community and hospital care. Three main themes were identified: difficulties in handover between primary and secondary care (ambiguous roles and communication difficulties), short-term focus in clinical consultations (underplaying risk so as not to overwhelm patients and competing priorities) and patient-centric barriers. Conclusion: We identified barriers to diabetes screening at both system and individual levels. At the system level, clarification of responsibility for testing among healthcare professionals and better systems for recall are needed. These could be achieved through registers, improved clinical protocols, and automatic flagging and prompts within electronic medical records. At the individual level, clinicians should be supported to prioritise the importance of screening within consultations and better educational resources made available for women. Making it more convenient for women to attend may also facilitate screening.

Combining patient talk about internet use during primary care consultations with retrospective accounts. A qualitative analysis of interactional and interview data

Despite widespread acknowledgement of internet use for information about health, patients report not disclosing use of online health information in consultations. This paper compares patients' reported use of the internet with matched video recordings of consultations. The concepts of doctorability and epistemics are employed to consider similarities and differences between patients’ reports in interviews and actions in the consultation. Data are drawn from the Harnessing Resources from the Internet study conducted in the UK. The data set consists of 281 video-recorded general practice consultations, with pre-consultation questionnaires completed by all patients, interviews with all 10 participating doctors and 28 selected patients. We focus on the 28 patient interviews and associated consultation recordings. A conversation analytic (CA) approach is used to systematically inspect both the interview and consultation data. In interviews patients presented use of the internet as associated with appropriate self-management and help-seeking. In consultations patients skilfully translated what they had found on the internet in order to provide grounds for the actions they sought. We conclude that patients translate and utilise what they have found on the internet to assert the doctorability of their presenting problems. Furthermore, patients design their talk in both interviews and consultations to accord with their understanding of the epistemic rights of both doctors and patients. Patients search the internet so they are informed about their medical problem, however they carefully manage disclosure of information to avoid disrupting the smooth running of medical interactions.

Test‐guided dietary management of eczema in children: A randomized controlled feasibility trial (TEST)

Background: Parents commonly ask about food allergy tests, to find a cause for their child's eczema, yet the value of routine testing is uncertain. Objective: To determine whether a clinical trial comparing test‐guided dietary advice versus usual care, for the management of eczema, is feasible. Methods: Children (>3 months and <5 years) with mild‐to‐severe eczema, recruited via primary care, were individually randomized (1:1) to intervention or usual care. Intervention participants underwent structured allergy history and skin prick tests (SPT) with dietary advice for cow's milk, hen's egg, wheat, peanut, cashew and codfish. All participants were followed up for 24 weeks. A sample of doctors and parents was interviewed. Registration ISRCTN15397185. Results: From 1059 invitation letters sent to carers of potentially eligible children, 84 were randomized (42 per group) with mean age of 32.4 months (SD 13.9) and POEM of 8.7 (4.8). Of the 42, 6 (14%) intervention participants were advised to exclude one or more foods, most commonly egg, peanut or milk. By participant, 1/6 had an oral food challenge (negative); 3/6 were told to exclude until review in allergy clinic; and 6/6 advised a home dietary trial (exclusion and reintroduction of food over 4–6 weeks) – with 1/6 partially completing it. Participant retention (four withdrawals) and data completeness (74%–100%) were acceptable and contamination low (two usual care participants had allergy tests). There were three minor SPT‐related adverse events. During follow‐up, 12 intervention and 8 usual care participants had minor, unrelated adverse events plus one unrelated hospital admission. Conclusions: It is possible to recruit, randomize and retain children with eczema from primary care into a trial of food allergy screening and to collect the outcomes of interest. Changes to recruitment and inclusion criteria are needed in a definitive trial, to ensure inclusion of younger children from more diverse backgrounds.

Views and experiences of people with acne vulgaris and healthcare professionals about treatments: systematic review and thematic synthesis of qualitative research

Objectives: The objective of this study was to systematically review and synthesise qualitative papers exploring views and experiences of acne and its treatments among people with acne, their carers and healthcare professionals (HCPs). Design: Systematic review and synthesis of qualitative papers. Methods: Papers were identified through Medline, EMBASE, PubMed, PsychINFO and CINAHL on 05 November 2019, forward and backward citation searching, Google Scholar and contacting authors. Inclusion criteria were studies reporting qualitative data and analysis, studies carried out among people with acne, their carers or HCPs and studies comprising different skin conditions, including acne. The title and abstracts of papers were independently screened by three researchers. Appraisal was carried out using the adapted Critical Appraisal Skills Programme tool. Thematic synthesis was used to synthesise findings. Results: A total of 20 papers were included from six countries. Papers explored; experiences living with acne, psychosocial impact of acne, views on causation of acne, perceptions of acne treatments, ambivalence and ambiguity in young people’s experience of acne and HCPs’ attitudes towards acne management. Findings suggest that people often viewed acne as short-term and that this had implications for acne management, particularly long-term treatment adherence. People often felt that the substantial impact of acne was not recognised by others, or that their condition was ‘trivialised’ by HCPs. The sense of a lack of control over acne and control over treatment was linked to both psychological impact and treatment adherence. Concerns and uncertainty over acne treatments were influenced by variable advice and information from others. Conclusions: People need support with understanding the long-term management of acne, building control over acne and its treatments, acknowledging the impact and appropriate information to reduce the barriers to effective treatment use.

Sex, Age, and Socioeconomic Differences in Nonfatal Stroke Incidence and Subsequent Major Adverse Outcomes

Background and Purpose: Data about variations in stroke incidence and subsequent major adverse outcomes are essential to inform secondary prevention and prioritizing resources to those at the greatest risk of major adverse end points. We aimed to describe the age, sex, and socioeconomic differences in the rates of first nonfatal stroke and subsequent major adverse outcomes. Methods: The cohort study used linked Clinical Practice Research Datalink and Hospital Episode Statistics data from the United Kingdom. The incidence rate (IR) ratio of first nonfatal stroke and subsequent major adverse outcomes (composite major adverse cardiovascular events, recurrent stroke, cardiovascular disease-related, and all-cause mortality) were calculated and presented by year, sex, age group, and socioeconomic status based on an individual’s location of residence, in adults with incident nonfatal stroke diagnosis between 1998 and 2017. Results: A total of 82 774 first nonfatal stroke events were recorded in either primary care or hospital data—an IR of 109.20 per 100 000 person-years (95% CI, 108.46–109.95). Incidence was significantly higher in women compared with men (IR ratio, 1.13 [95% CI, 1.12–1.15]; P<0.001). Rates adjusted for age and sex were higher in the lowest compared with the highest socioeconomic status group (IR ratio, 1.10 [95% CI, 1.08–1.13]; P<0.001). For subsequent major adverse outcomes, the overall incidence for major adverse cardiovascular event was 38.05 per 100 person-years (95% CI, 37.71–38.39) with a slightly higher incidence in women compared with men (38.42 versus 37.62; IR ratio, 1.02 [95% CI, 1.00–1.04]; P=0.0229). Age and socioeconomic status largely accounted for the observed higher incidence of adverse outcomes in women. Conclusions: In the United Kingdom, incidence of initial stroke and subsequent major adverse outcomes are higher in women, older populations, and people living in socially deprived areas.

D-MannosE to prevent Recurrent urinary tract InfecTions (MERIT): protocol for a randomised controlled trial

Introduction: Recurrent urinary tract infections (RUTIs) have a significant negative impact on quality of life and healthcare costs. To date, daily prophylactic antibiotics are the only treatment which have been shown to help prevent RUTIs. D-mannose is a type of sugar which is believed to inhibit bacterial adherence to uroepithelial cells, and is already being used by some women in an attempt to prevent RUTIs. There is currently insufficient rigorous evidence on which to base decisions about its use. The D-mannose to prevent recurrent urinary tract infections (MERIT) study will evaluate whether D-mannose is clinically and cost-effective in reducing frequency of infection and symptom burden for women presenting to UK primary care with RUTI. Methods and analysis: MERIT will be a two-arm, individually randomised, double blind placebo controlled, pragmatic trial. Participants will be randomised to take D-mannose powder or placebo powder daily for 6 months. The primary outcome will be the number of medical attendances attributable to symptoms of RUTI. With 508 participants we will have 90% power to detect a 50% reduction in the chance of a further clinically suspected UTI, assuming 20% lost to follow-up. Secondary outcomes will include: number of days of moderately bad symptoms of UTI; time to next consultation; number of clinically suspected UTIs; number of microbiologically proven UTIs; number of antibiotic courses for UTI; quality of life and healthcare utilisation related to UTI. A within trial economic evaluation will be conducted to examine cost-effectiveness of D-mannose in comparison with placebo. A nested qualitative study will explore participants’ experiences and perceptions of recruitment to, and participation in a study requiring a daily treatment.