Search results

Out-of-hours services and end-of-life hospital admissions: a complex intervention systematic review and narrative synthesis

Background Out-of-hours (OOH) hospital admissions for patients receiving end-of-life care are a common cause of concern for patients, families, clinicians, and policymakers. It is unclear what issues, or combinations of issues, lead OOH clinicians to initiate hospital care for these patients. Aim To investigate the circumstances, processes, and mechanisms of UK OOH services-initiated end-of-life care hospital admissions. Design and setting Systematic literature review and narrative synthesis. Method Eight electronic databases were searched from inception to December 2019 supplemented by hand-searching of the British Journal of General Practice. Key search terms included: ‘out-of-hours services’, ‘hospital admissions’, and ‘end-of-life care’. Two reviewers independently screened and selected articles, and undertook quality appraisal using Gough’s Weight of Evidence framework. Data was analysed using narrative synthesis and reported following PRISMA Complex Intervention guidance. Results Searches identified 20 727 unique citations, 25 of which met the inclusion criteria. Few studies had a primary focus on the review questions. Admissions were instigated primarily to address clinical needs, caregiver and/or patient distress, and discontinuity or unavailability of care provision, and they were arranged by a range of OOH providers. Reported frequencies of patients receiving end-of-life care being admitted to hospital varied greatly; most evidence related to cancer patients. Conclusion Although OOH end-of-life care can often be readily resolved by hospital admissions, it comes with multiple challenges that seem to be widespread and systemic. Further research is therefore necessary to understand the complexities of OOH services-initiated end-of-life care hospital admissions and how the challenges underpinning such admissions might best be addressed.

Factors affecting the documentation of spoken safety-netting advice in routine GP consultations: a cross-sectional study

Background Previous studies have reported how often safety-netting is documented in medical records, but it is not known how this compares with what is verbalised and what factors might influence the consistency of documentation. Aim To compare spoken and documented safety-netting advice and to explore factors associated with documentation. Design and setting A cross-sectional study, using an existing GP consultations archive. Method Observational coding involving classifying and quantifying medical record entries and comparison with spoken safety-netting advice in 295 video-/audio-recorded consultations. Associations were tested using logistic regression. Results Two-thirds of consultations (192/295) contained spoken safety-netting advice that applied to less than half of the problems assessed (242/516). Only one-third of consultations (94/295) had documented safety-netting advice, which covered 20.3% of problems (105/516). The practice of GPs varied widely, from those that did not document their safety-netting advice to those that nearly always did so (86.7%). GPs were more likely to document their safety-netting advice for new problems (P = 0.030), when only a single problem was discussed in a consultation (P = 0.040), and when they gave specific rather than generic safety-netting advice (P = 0.007). In consultations where multiple problems were assessed (n = 139), the frequency of spoken and documented safety-netting advice decreased the later a problem was assessed. Conclusion GPs frequently do not document the safety-netting advice they have given to patients, which may have medicolegal implications in the event of an untoward incident. GPs should consider how safely they can assess and document more than one problem in a single consultation and this risk should be shared with patients to help manage expectations.

Factors affecting primary care practitioners’ alcohol-related discussions with older adults: a qualitative study

Background Risk of harm from drinking is heightened in later life, owing to age-related sensitivities to alcohol. Primary care services have a key role in supporting older people (aged ≥50 years) to make healthier decisions about alcohol. Aim To examine primary care practitioners’ perceptions of factors that promote and challenge their work to support older people in alcohol risk-reduction. Design and setting Qualitative study consisting of semi-structured interviews and focus groups with primary care practitioners in Northern England. Method Thirty-five practitioners (GPs, practice/district nurses, pharmacists, dentists, social care practitioners, and domiciliary carers) participated in eight interviews and five focus groups. Data were analysed thematically, applying principles of constant comparison. Results Practitioners highlighted particular sensitivities to discussing alcohol among older people, and reservations about older people’s resistance to making changes in old age; given that drinking practices could be established, and promote socialisation and emotional wellbeing in later life. Age-related health issues increased older people’s contact with practitioners, but management of older people’s long-term conditions was prioritised over discussion of alcohol. Dedicated time to address alcohol in routine consultations with older people and training in alcohol intervention facilitated practitioners, particularly pharmacists and practice nurses. Conclusion There are clear opportunities to support older people in primary care to make healthier decisions about alcohol. Dedicated time to address alcohol, training in identification of alcohol-related risks (particularly those associated with old age), and tailored interventions for older people, feasible to implement in practice settings, would help primary care practitioners to address older people’s alcohol use.

A feasibility trial of a digital mindfulness-based intervention to improve asthma-related quality of life for primary care patients with asthma

Asthma outcomes remain suboptimal, despite effective pharmacotherapy. Psychological dysfunction (such as anxiety) is common, and associated with poorer outcomes. We evaluated a digital mindfulness programme as an intervention to improve asthma-related quality of life for primary care patients, in a prospectively registered randomized-controlled feasibility study. We offered ‘Headspace’, a widely-used digital mindfulness intervention, to adults with asthma through 16 UK GP practices. Participants were randomized on a 2:1 basis to the mindfulness intervention, or waitlist control. Participants completed questionnaires (including asthma symptom control, asthma-related quality of life, anxiety, depression) at baseline, 6-week and 3-month follow-up. 116 participants completed primary outcomes at 3-month follow-up: intervention 73 (79%), control 43 (84%). Compared to baseline, the intervention group but not the control group reported significantly improved asthma-related quality of life, with a between-group difference favoring the intervention group that was not significant (Mean difference = 0.15, 95%CI − 0.13 to 0.42). Intervention use varied (ranging from 0 to 192 times) but was generally high. Digital mindfulness interventions are feasible and acceptable adjunct treatments for mild and moderate asthma to target quality of life. Further research should adapt ‘generic’ mindfulness-based stress-reduction to maximize effectiveness for asthma, and validate our findings in a fully-powered randomized controlled trial.

‘I’ve never drunk very much water and I still don’t, and I see no reason to do so’: a qualitative study of the views of community-dwelling older people and carers on hydration in later life

Dehydration is associated with significant adverse outcomes in older people despite being largely preventable and treatable. Little research has focused on the views of community-dwelling older people on hydration, healthy drinking and the perceived importance of drinking well in later life.

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

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).

Blood pressure changes following antihypertensive medication reduction, by drug class and dose chosen for withdrawal: exploratory analysis of data from the OPTiMISE trial

Aims: Deprescribing of antihypertensive drugs is recommended for some older patients with polypharmacy, but there is little evidence to inform which drug (or dose) should be withdrawn. This study used data from the OPTiMISE trial to examine whether short-term outcomes of deprescribing vary by drug class and dose of medication withdrawn. Methods: The OPTiMISE trial included patients aged ≥80 years with controlled systolic blood pressure (SBP; <150 mmHg), receiving ≥2 antihypertensive medications. This study compared SBP control, mean change in SBP and frequency of adverse events after 12-weeks in participants stopping one medication vs. usual care, by drug class and equivalent dose of medication withdrawn. Equivalent dose was determined according to the defined daily dose (DDD) of each medication type. Drugs prescribed below the DDD were classed as low dose and those prescribed at ≥DDD were described as higher dose. Outcomes were examined by generalised linear mixed effects models. Results: A total of 569 participants were randomised, aged 85±3 years with controlled blood pressure (mean 130/69mmHg). Within patients prescribed calcium channel blockers, higher dose medications were more commonly selected for withdrawal (90% vs. 10%). In those prescribed beta-blockers, low dose medications were more commonly chosen (87% vs. 13%). Withdrawal of calcium channel blockers was associated with an increase in SBP (5mmHg, 95%CI 0 to 10 mmHg) and reduced SBP control (adjusted RR 0.89, 95%CI 0.80 to 0.998) compared to usual care. In contrast, withdrawal of beta-blockers was associated with no change in SBP (-4mmHg, 95%CI -10 to 2mmHg) and no difference in SBP control (adjusted RR 1.15, 95%CI 0.96 to 1.37). Similarly, withdrawal of higher dose medications was associated with an increase in SBP but no change in BP control. Withdrawal of lower dose medications was not associated with a difference in SBP or SBP control. There was no association between withdrawal of specific drug classes and adverse events. Conclusions: These exploratory data suggest withdrawal of higher dose calcium channel blockers should be avoided if the goal is to maintain BP control. However, low dose beta blockers may be removed with little impact on blood pressure over 12-weeks of follow-up. Larger studies are needed to confirm these associations.

Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? A feasibility randomised trial

OBJECTIVES: To determine the feasibility of conducting a randomised trial of the effectiveness of cranberry extract in reducing antibiotic use by women with symptoms of acute, uncomplicated urinary tract infection (UTI). DESIGN: Open-label feasibility randomised parallel group trial. SETTING: Four general practices in Oxfordshire. PARTICIPANTS: Women aged 18 years and above presenting to general practice with symptoms of acute, uncomplicated UTI. INTERVENTIONS: Women were randomly assigned using Research Electronic Data Capture in a 1:1:1 ratio to: (1) immediate antibiotics alone (n=15); (2) immediate antibiotics and immediate cranberry capsules for up to 7 days (n=15); or (3) immediate cranberry capsules and delayed antibiotics for self-initiation in case of non-improvement or worsening of symptoms (n=16). PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measures were: rate of recruitment of participants; numbers lost to follow-up; proportion of electronic diaries completed by participants; and acceptability of the intervention and study procedures to participants and recruiters. Secondary outcomes included an exploration of differences in symptom burden and antibiotic use between groups. RESULTS: Four general practitioner practices (100%) were opened and recruited participants between 1 July and 2 December 2019, with nine study participants recruited per month on average. 68.7% (46/67) of eligible participants were randomised (target 45) with a mean age of 48.4 years (SD 19.9, range 18-81). 89.1% (41/46) of diaries contained some participant entered data and 69.6% (32/46) were fully complete. Three participants (6.5%) were lost to follow-up and two (4.4%) withdrew. Of women randomly assigned to take antibiotics alone (controls), one-third of respondents reported consuming cranberry products (33.3%, 4/12). There were no serious adverse events. CONCLUSIONS: It appears feasible to conduct a randomised trial of the use of cranberry extract in the treatment of acute, uncomplicated UTI in general practice. TRIAL REGISTRATION NUMBER: ISRCTN Registry (ID: 10399299).

‘I’m fine!’: Assertions of lack of support need among patients with chronic obstructive pulmonary disease: A mixed-methods study

Objectives: To understand how people with Chronic Obstructive Pulmonary Disease (COPD) disavow their support needs and the impact on care. Methods: Two stage mixed-method design. Stage 1 involved sub-analyses of data from a mixed-method population-based longitudinal study exploring the needs of patients with advanced COPD. Using adapted criteria from mental health research, we identified 21 patients who disavowed their needs from the 235 patient cohort. Qualitative interview transcripts and self-report measures were analysed to compare these patients with the remaining cohort. In stage 2 focus groups (n = 2) with primary healthcare practitioners (n = 9) explored the implications of Stage 1 findings. Results: Patients who disavowed their support needs described non-compliance with symptom management and avoidance of future care planning (qualitative data). Analysis of self-report measures of mental and physical health found this group reported fewer needs than the remaining sample yet wanted more GP contact. The link between risk factors and healthcare professional involvement present in the rest of the sample was missing for these patients. Focus group data suggested practitioners found these patients challenging. Discussion: This study identified patients with COPD who disavow their support needs, but who also desire more GP contact. GPs report finding these patients challenging to engage.

Experience of implementing and delivering group consultations in UK general practice: a qualitative study

Background: Group consultations are a relatively new concept in UK primary care and are a suggested solution to current workload pressures in general practice. Little is known about the experience of implementing and delivering this approach from staff and organisational perspectives. Aim: To explore the experience of implementing and delivering group consultations in general practice. Design and setting: Qualitative telephone interview study. Method: Topic guides explored the perspectives and experiences of general practice staff on the implementation and delivery of group consultations. Data analysis adopted principles of the Framework Method underpinned by Normalisation Process Theory. Results: Interviews were conducted with 8 GPs, 8 practice nurses, 1 nurse associate, 1 practice pharmacist, 1 deputy practice manager, and 1 healthcare assistant. Four themes were identified: sense making of group consultations; the work associated with initiating group consultations; the experiences of operationalising group consultations; and sustaining change. Group consultations made sense to participants as a mechanism to reduce burden on primary care, enhance multidisciplinary working, and provide patient-centred care. Implementation required strong leadership from a ‘champion’, and a facilitator had a pivotal role in operationalising the approach. The associated workload was often underestimated. Barriers to embedding change included achieving whole practice buy-in, competing practice priorities, and system-level flexibility. Conclusion: General practice clinicians enjoyed group consultations, yet significant work is required to initiate and sustain the approach. An implementation plan considering leadership, roles and responsibilities, and wider organisational support is required at the outset. Further research or evaluation is needed to measure process outcomes.

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.