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What is known about adolescent dysmenorrhoea in (and for) community health settings?
Introduction: Dysmenorrhoea affects many adolescents with significant impacts on education and well-being. In the UK, most of the adolescents who seek care (and many never do), will do so through general practice (primary care). Knowing how best to care for adolescents reporting menstrual pain is an area where UK general practitioners would like better guidance and resources. Methods: This mixed-methods narrative synthesis collates community and specialist evidence from 320 papers about adolescent dysmenorrhoea, with a UK general practice community health perspective. Results: We report a narrative summary of symptoms, cause, consequences and treatments for adolescent dysmenorrhoea. We highlight areas of tension or conflicted evidence relevant to primary care alongside areas of uncertainty and research gaps identified through this synthesis with input from lived experience advisers Discussion: There is little evidence about primary care management of adolescent dysmenorrhoea or specific resources to support shared-decision making in general practice, although there are evidence-based treatments to offer. Primary care encounters also represent potential opportunities to consider whether the possibility of underlying or associated health conditions contributing to symptoms of dysmenorrhoea, but there is little epidemiological evidence about prevalence from within community health settings to inform this. The areas where there is little or uncertain evidence along the care journey for adolescent dysmenorrhoea, including at the interface between experience and expression of symptoms and potential underlying contributory causes warrant further exploration. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPEROFILES/256458_STRATEGY_20210608.pdf, identifier (CRD42021256458).
Patient-Clinician Communication About Weight Loss
This JAMA Insights explores effective communication strategies for clinicians who do not specialize in treating obesity in how to introduce conversations about weight loss with their patients and offer them support and treatment.
Dynamic updating of clinical survival prediction models in a changing environment.
BACKGROUND: Over time, the performance of clinical prediction models may deteriorate due to changes in clinical management, data quality, disease risk and/or patient mix. Such prediction models must be updated in order to remain useful. In this study, we investigate dynamic model updating of clinical survival prediction models. In contrast to discrete or one-time updating, dynamic updating refers to a repeated process for updating a prediction model with new data. We aim to extend previous research which focused largely on binary outcome prediction models by concentrating on time-to-event outcomes. We were motivated by the rapidly changing environment seen during the COVID-19 pandemic where mortality rates changed over time and new treatments and vaccines were introduced. METHODS: We illustrate three methods for dynamic model updating: Bayesian dynamic updating, recalibration, and full refitting. We use a simulation study to compare performance in a range of scenarios including changing mortality rates, predictors with low prevalence and the introduction of a new treatment. Next, the updating strategies were applied to a model for predicting 70-day COVID-19-related mortality using patient data from QResearch, an electronic health records database from general practices in the UK. RESULTS: In simulated scenarios with mortality rates changing over time, all updating methods resulted in better calibration than not updating. Moreover, dynamic updating outperformed ad hoc updating. In the simulation scenario with a new predictor and a small updating dataset, Bayesian updating improved the C-index over not updating and refitting. In the motivating example with a rare outcome, no single updating method offered the best performance. CONCLUSIONS: We found that a dynamic updating process outperformed one-time discrete updating in the simulations. Bayesian updating offered good performance overall, even in scenarios with new predictors and few events. Intercept recalibration was effective in scenarios with smaller sample size and changing baseline hazard. Refitting performance depended on sample size and produced abrupt changes in hazard ratio estimates between periods.
Uptake, effectiveness and safety of COVID-19 vaccines in individuals at clinical risk due to immunosuppressive drug therapy or transplantation procedures: a population-based cohort study in England
Background: Immunocompromised individuals are at increased risk of severe COVID-19 outcomes, underscoring the importance of COVID-19 vaccination in this population. The lack of comprehensive real-world data on vaccine uptake, effectiveness and safety in these individuals presents a critical knowledge gap, highlighting the urgency to better understand and address the unique challenges faced by immunocompromised individuals in the context of COVID-19 vaccination. Methods: We analysed data from 12,274,946 people in the UK aged > 12 years from 01/12/2020 to 11/04/2022. Of these, 583,541 (4.8%) were immunocompromised due to immunosuppressive drugs, organ transplants, dialysis or chemotherapy. We undertook a cohort analysis to determine COVID-19 vaccine uptake, nested case–control analyses adjusted for comorbidities and sociodemographic characteristics to determine effectiveness of vaccination against COVID-19 hospitalisation, ICU admission and death, and a self-controlled case series assessing vaccine safety for pre-specified adverse events of interest. Results: Overall, 93.7% of immunocompromised individuals received at least one COVID-19 vaccine dose, with 80.4% having received three or more doses. Uptake reduced with increasing deprivation (hazard ratio [HR] 0.78 [95%CI 0.77–0.79] in the most deprived quintile compared to the least deprived quintile for the first dose). Estimated vaccine effectiveness against COVID-19 hospitalisation 2–6 weeks after the second and third doses compared to unvaccinated was 78% (95%CI 72–83) and 91% (95%CI 88–93) in the immunocompromised population, versus 85% (95%CI 83–86) and 86% (95%CI 85–89), respectively, for the general population. Results showed COVID-19 vaccines were protective against intensive care unit (ICU) admission and death in both populations, with effectiveness of over 92% against COVID-19-related death and up to 95% in reducing ICU admissions for both populations following the third dose. COVID-19 vaccines were generally safe for immunocompromised individuals, though specific doses of ChAdOx1, mRNA-1273 and BNT162b2 raised risks of specific cardiovascular/neurological conditions. Conclusions: COVID-19 vaccine uptake is high in immunocompromised individuals on immunosuppressive drug therapy or who have undergone transplantation procedures, with documented disparities by deprivation. Findings suggest that COVID-19 vaccines are protective against severe COVID-19 outcomes in this vulnerable population, and show a similar safety profile in immunocompromised individuals and the general population, despite some increased risk of adverse events. These results underscore the importance of ongoing vaccination prioritisation for this clinically at-risk population to maximise protection against severe COVID-19 outcomes.
Talking in primary care (TIP): Protocol for a cluster-randomised controlled trial in UK primary care to assess clinical and cost-effectiveness of communication skills e-learning for practitioners on patients' musculoskeletal pain and enablement
Introduction Effective communication can help optimise healthcare interactions and patient outcomes. However, few interventions have been tested clinically, subjected to cost-effectiveness analysis or are sufficiently brief and well-described for implementation in primary care. This paper presents the protocol for determining the effectiveness and cost-effectiveness of a rigorously developed brief eLearning tool, EMPathicO, among patients with and without musculoskeletal pain. Methods and analysis A cluster randomised controlled trial in general practitioner (GP) surgeries in England and Wales serving patients from diverse geographic, socioeconomic and ethnic backgrounds. GP surgeries are randomised (1:1) to receive EMPathicO e-learning immediately, or at trial end. Eligible practitioners (eg, GPs, physiotherapists and nurse practitioners) are involved in managing primary care patients with musculoskeletal pain. Patient recruitment is managed by practice staff and researchers. Target recruitment is 840 adults with and 840 without musculoskeletal pain consulting face-to-face, by telephone or video. Patients complete web-based questionnaires at preconsultation baseline, 1 week and 1, 3 and 6 months later. There are two patient-reported primary outcomes: pain intensity and patient enablement. Cost-effectiveness is considered from the National Health Service and societal perspectives. Secondary and process measures include practitioner patterns of use of EMPathicO, practitioner-reported self-efficacy and intentions, patient-reported symptom severity, quality of life, satisfaction, perceptions of practitioner empathy and optimism, treatment expectancies, anxiety, depression and continuity of care. Purposive subsamples of patients, practitioners and practice staff take part in up to two qualitative, semistructured interviews. Ethics approval and dissemination Approved by the South Central Hampshire B Research Ethics Committee on 1 July 2022 and the Health Research Authority and Health and Care Research Wales on 6 July 2022 (REC reference 22/SC/0145; IRAS project ID 312208). Results will be disseminated via peer-reviewed academic publications, conference presentations and patient and practitioner outlets. If successful, EMPathicO could quickly be made available at a low cost to primary care practices across the country. Trial registration number ISRCTN18010240.
Internet and Telephone Support for Discontinuing Long-Term Antidepressants: The REDUCE Cluster Randomized Trial
Importance: There is significant concern regarding increasing long-term antidepressant treatment for depression beyond an evidence-based duration. Objective: To determine whether adding internet and telephone support to a family practitioner review to consider discontinuing long-term antidepressant treatment is safe and more effective than a practitioner review alone. Design, Setting, and Participants: In this cluster randomized clinical trial, 131 UK family practices were randomized between December 1, 2018, and March 31, 2022, with remote computerized allocation and 12 months of follow-up. Participants and researchers were aware of allocation, but analysis was blind. Participants were adults who were receiving antidepressants for more than 1 year for a first episode of depression or more than 2 years for recurrent depression who were currently well enough to consider discontinuation and wished to do so and who were at low risk of relapse. Of 6725 patients mailed invitations, 330 (4.9%) were eligible and consented. Interventions: Internet and telephone self-management support, codesigned and coproduced with patients and practitioners. Main Outcomes and Measures: The primary (safety) outcome was depression at 6 months (prespecified complete-case analysis), testing for noninferiority of the intervention to under 2 points on the 9-item Patient Health Questionnaire (PHQ-9). Secondary outcomes (testing for superiority) were antidepressant discontinuation, anxiety, quality of life, antidepressant withdrawal symptoms, mental well-being, enablement, satisfaction, use of health care services, and adverse events. Analyses for the main outcomes were performed on a complete-case basis, and multiple imputation sensitivity analysis was performed on an intention-to-treat basis. Results: Of 330 participants recruited (325 eligible for inclusion; 178 in intervention practices and 147 in control practices; mean [SD] age at baseline, 54.0 [14.9] years; 223 women [68.6%]), 276 (83.6%) were followed up at 6 months, and 240 (72.7%) at 12 months. The intervention proved noninferior; mean (SD) PHQ-9 scores at 6 months were slightly lower in the intervention arm than in the control arm in the complete-case analysis (4.0 [4.3] vs 5.0 [4.7]; adjusted difference, -1.1; 95% CI, -2.1 to -0.1; P =.03) but not significantly different in an intention-to-treat multiple imputation sensitivity analysis (adjusted difference, -0.9 (95% CI, -1.9 to 0.1; P =.08). By 6 months, antidepressants had been discontinued by 66 of 145 intervention arm participants (45.5%) who provided discontinuation data and 54 of 129 control arm participants (41.9%) (adjusted odds ratio, 1.02; 95% CI, 0.52-1.99; P =.96). In the intervention arm, antidepressant withdrawal symptoms were less severe, and mental well-being was better compared with the control arm; differences were small but significant. There were no significant differences in the other outcomes; 28 of 179 intervention arm participants (15.6%) and 22 of 151 control arm participants (14.6%) experienced adverse events. Conclusions and Relevance: In this cluster randomized clinical trial of adding internet and telephone support to a practitioner review for possible antidepressant discontinuation, depression was slightly better with support, but the rate of discontinuation of antidepressants did not significantly increase. Improvements in antidepressant withdrawal symptoms and mental well-being were also small. There were no significant harms. Family practitioner review for possible discontinuation of antidepressants appeared safe and effective for more than 40% of patients willing and well enough to discontinue. Trial Registration: ISRCTN registry Identifiers: ISRCTN15036829 (internal pilot trial) and ISRCTN12417565 (main trial).
Identifying barriers and potential solutions to improve equitable access to community eye services: an exploratory sequential mixed methods study protocol.
INTRODUCTION: Access to care varies by sociodemographic group, with some groups facing higher barriers to care than others. This study will use novel methods to explore barriers and potential solutions as perceived by members of the population groups who are least able to access care. We aim to use rapid yet robust mixed methods that allow us to identify generalisable findings within each programme and testable service modifications to improve equitable access to care; delivering non-tokenistic findings within a matter of weeks. METHODS AND ANALYSIS: This is a multiphased exploratory sequential mixed methods study. We will use the same approach in four different screening programmes, in Botswana, India, Kenya and Nepal. First, we will conduct interviews with people purposively selected from the sociodemographic subgroups with the lowest odds of accessing care within each programme. We will explore their perceptions of barriers and potential service modifications that could boost attendance at eye clinics among people from these 'left-behind' groups. We will use a deductive analytic matrix to facilitate the rapid analysis of qualitative data. Space will be made for the inductive identification of themes that are not necessarily captured in the framework. Sample size will be determined by thematic saturation. Next, we will conduct a survey with a representative sample of non-attenders from the same left-behind groups, asking them to rank each suggested service modification by likely impact. Finally, we will convene a multistakeholder workshop to assess each service modification based on ranking, likely impact, feasibility, cost and potential risks. The most promising service modifications will be implemented and evaluated in a follow-on randomised controlled trial, the methods for which will be reported elsewhere. ETHICS AND DISSEMINATION: This project has been approved by independent research ethics committees in Botswana, Kenya, India, Nepal and the UK. We will disseminate our findings through local community advisory boards, national eye screening meetings, in peer-reviewed journals and at conferences.
Protocol for an adaptive platform trial of intended service user-derived interventions to equitably reduce non-attendance in eye screening programmes in Botswana, India, Kenya and Nepal
IntroductionOnly 30%–50% of people referred to clinics during community-based eye screening are able to access care in Botswana, India, Kenya and Nepal. The access rate is even lower for certain population groups. This platform trial aims to test multiple, iterative, low-risk public health interventions and simple service modifications with a series of individual randomised controlled trials (RCT) conducted in each country, with the aim of increasing the proportion of people attending.Methods and analysisWe will set up a platform trial in each country to govern the running of a series of pragmatic, adaptive, embedded, parallel, multiarm, superiority RCTs to test a series of service modifications suggested by intended service users. The aim is to identify serial marginal gains that cumulatively result in large improvements to equity and access. The primary outcome will be the probability of accessing treatment among the population group with the worst access at baseline. We will calculate Bayesian posterior probabilities of clinic attendance in each arm every 72 hours. Each RCT will continually recruit participants until the following default stopping rules have been met: >95% probability that one arm is best; >95% probability that the difference between the best arm and the arms remaining in the trial is <1%; or 10 000 people have been recruited. Lower thresholds may be used for RCTs testing interventions with very low risks and costs. The specific design of cluster RCTs will be determined by our research team once the intervention is known, but the population and outcome will be the same across all trials.This adaptive platform trial will be used to identify effective service modifications, driving continuous improvements in access.Ethics and disseminationThis trial has been approved by the research ethics committee at the London School of Hygiene & Tropical Medicine (ref: 29549). Approvals for individual interventions will be sought from UK and local ethics committees. Results will be shared via local workshops, social media and peer-reviewed publications.Trial registration numberISRCTN53970958.
Alterations in care for children with special healthcare needs during the early COVID-19 pandemic: ethical and policy considerations
Healthcare delivery and access, both in the United States and globally, were negatively affected during the entirety of the COVID-19 pandemic. This was particularly true during the first year when countries grappled with high rates of illness and implemented non-pharmaceutical interventions such as stay-at-home orders. Among children with special healthcare needs, research from the United Kingdom (U.K.) has shown that the pandemic response uniquely impacted various aspects of their care, including decreased access to care, delays in diagnosis, and poorer chronic disease control. In response to these findings, and to begin to comprehend whether the concerning findings from the nationalized system of healthcare in the U.K. extend to the highly dissimilar United States (U.S.) healthcare context, we reviewed the literature on alterations in access to and delivery of care during the early stages of the COVID-19 pandemic for children with special healthcare needs in the U.S. We then utilize these findings to consider the ethical and policy considerations of alterations in healthcare provision during pandemics and crisis events in the U.K. and U.S. and make recommendations regarding how the needs of CSHCN should be considered during future responses.
Clinical diagnosis of SARS-CoV-2 infection: An observational study of respiratory tract infection in primary care in the early phase of the pandemic
Background: Early in the COVID-19 pandemic, GPs had to distinguish SARS-CoV-2 from other aetiologies in patients presenting with respiratory tract infection (RTI) symptoms on clinical grounds and adapt management accordingly. Objectives: To test the diagnostic accuracy of GPs’ clinical diagnosis of a SARS-CoV-2 infection in a period when COVID-19 was a new disease. To describe GPs’ management of patients presenting with RTI for whom no confirmed diagnosis was available. To investigate associations between patient and clinical features with a SARS-CoV-2 infection. Methods: In April 2020–March 2021, 876 patients (9 countries) were recruited when they contacted their GP with symptoms of an RTI of unknown aetiology. A swab was taken at baseline for later analysis. Aetiology (PCR), diagnostic accuracy of GPs’ clinical SARS-CoV-2 diagnosis, and patient management were explored. Factors related to SARS-CoV-2 infection were determined by logistic regression modelling. Results: GPs suspected SARS-CoV-2 in 53% of patients whereas 27% of patients tested positive for SARS-CoV-2. True-positive patients (23%) were more intensively managed for follow-up, antiviral prescribing and advice than true-negatives (42%). False negatives (5%) were under-advised, particularly for social distancing and isolation. Older age (OR: 1.02 (1.01–1.03)), male sex (OR: 1.68 (1.16–2.41)), loss of taste/smell (OR: 5.8 (3.7–9)), fever (OR: 1.9 (1.3–2.8)), muscle aches (OR: 2.1 (1.5–3)), and a known risk factor for COVID-19 (travel, health care worker, contact with proven case; OR: 2.7 (1.8–4)) were predictive of SARS-CoV-2 infection. Absence of loss of taste/smell, fever, muscle aches and a known risk factor for COVID-19 correctly excluded SARS-CoV-2 in 92.3% of patients, whereas presence of 3, or 4 of these variables correctly classified SARS-CoV-2 in 57.7% and 87.1%. Conclusion: Correct clinical diagnosis of SARS-CoV-2 infection, without POC-testing available, appeared to be complicated.
Recognition and Justice? Conceptualizing Support for Women Whose Children Are in Care or Adopted
This paper examines the views of mothers who have experienced (or are judged to be at risk of) recurrent removal of children into care or adoption. Drawing on their accounts of working with an intensive 18 month support program called Pause, we argue for the relevance of conceptualizing policy and practice with reference to Honneth’s theory of recognition and Fraser’s arguments about the need to address misrecognition through redistribution, attending to gendered political and economic injustice. The analysis draws on qualitative longitudinal interviews with 49 women, conducted as part of a national UK Department for Education (DfE)-funded evaluation of Pause. Each woman was interviewed up to four times over a period of up to 20 months, both during and after the Pause intervention. Case-based longitudinal analysis illuminates how stigma can obscure women’s rights and needs—including welfare entitlements and health, as well as rights to family life—and shows how support can act to enable both redistribution, advocating to ensure women’s rights in a context of diminishing public welfare, and recognition, challenging stigmatization through recognition of women’s motherhood, and of their rights to care, solidarity, respect and fun.
Monitoring activity of hip injury patients (MoHIP): a sub-study of the world hip trauma evaluation observational cohort study
Purpose: The aim of this study is to assess the feasibility of using wearable activity monitors to better understand recovery of mobility during the hospital-to-home transition of hip fracture patients, where ongoing care is provided in the community. Methods: This is an observational cohort study of adults admitted to a single centre with hip fracture from May 2018. Participants of the World Hip Trauma Evaluation (WHiTE) cohort study without cognitive impairment were eligible. Participants were recruited during their hospital stay and were asked to wear a CE-marked 3-axis logging accelerometer (Axivity AX3) for 4 months. After discharge, participants received monthly home visits from a primary care research nurse throughout their study participation. Results: A total 427 patients were screened for eligibility between May 2018 and August 2019. Of these 139 were eligible and 28 (20.1%) recruited. The most common reason for non-eligibility was cognitive impairment (n = 192, 66.7%). Of the eligible patients; 57 (41.0%) declined to participate in the study, mostly due to not wanting to wear a monitor on a lanyard (n = 27, 47.4%). Mean age of recruited participants was 75.8 (SD 8.7), with 18 (54.3%) female. At baseline, participant mobility status was as follows: 22 (78.6%) were freely mobile without aids, 4 (14.1%) mobilised outdoors with one aid, 1 (3.6%) mobilised outdoors with 2 aids or a frame and 1 (3.6%) was unable to mobilise outdoors unassisted. Of the 12 participants that have completed the 4-month follow-up period; 8 (66.7%) recovered full mobility and 4 (33.3%) did not. Activity levels captured by activity monitors were significantly different between these groups at 4 months. Conclusion(s): Our research indicates that activity monitors have the capability to capture recovery of activity in patients following a hip fracture and activity levels correlate with patient self-report of mobility. However, future monitoring strategies should be suitable for cognitively impaired patients and use non-intrusive devices. Impact: This knowledge may inform future community-based rehabilitation interventions and personalise care.
Health-Related Quality of Life in Long COVID: Mapping the Condition-Specific C19-YRSm Measure Onto the EQ-5D-5L.
BACKGROUND: Long COVID (LC) is a clinical syndrome with persistent, fluctuating symptoms subsequent to COVID-19 infection. LC has significant detrimental effects on health-related quality of life (HRQoL), activities of daily living (ADL), and work productivity. Condition-specific patient-reported outcome measures (PROMs), such as the modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) do not provide the health utility data required for cost-utility analyses of LC interventions. The aim of this study was to derive a mapping algorithm for the C19-YRSm to enable health utilities to be generated from this PROM. METHODS: Data were collected from a large study evaluating LC services in the UK. A total of 1434 people with LC had completed both the C19-YRSm and the EQ-5D. Correlation and linear regression analyses were applied to determine items from the C19-YRSm and covariates for inclusion in the algorithm. Model fit, mean differences across the range of EQ-5D-3L utility scores, and Bland-Altman plots were evaluated. Responsiveness (standardised response mean; SRM) of the mapped utilities was investigated on a subset of participants with repeat assessments. RESULTS: There was a strong level of association between 8 items and one domain on the C19-YRSm with the EQ-5D single-item dimensions. Model fit was good (R2 = 0.7). The mean difference between observed and mapped scores was <0.10 for the range from 0 to 1 indicating good targeting for positive values of the EQ-5D-3L. The SRM for the mapped EQ-5D-3L was 0.37 compared to 0.17 for the observed utility scores, suggesting the mapped EQ-5D-3L is more responsive to change. CONCLUSION: A simple, responsive, and robust mapping algorithm was developed to generate enable EQ-5D-3L health utilities from the C19-YRSm. This will facilitate economic evaluations of LC interventions, treatment, and management, as well as further helping to describe and characterise patients with LC irrespective of any treatment and interventions.
Evaluating the Cost-Effectiveness of Antenatal Screening for Major Structural Anomalies During the First Trimester of Pregnancy: A Decision Model
Objective: To assess the cost-effectiveness of modifying current antenatal screening by adding first trimester structural anomaly screening to standard of care second trimester anomaly screening. Design: Health economic decision model. Setting: National Health Service (NHS) in England and Wales. Population: Pregnant women attending for first trimester antenatal screening. Methods: The decision model estimated pregnancy outcomes (maternal and foetal) and 20-year costs for current screening practice and for a policy adding a protocol screening for eight major structural anomalies to the current first trimester ultrasound scan. Event probabilities, costs, and outcomes for the model were informed by meta-analyses, published literature, and expert opinion. Main Outcomes Measures: Expected numbers of pregnancy outcomes, healthcare costs, and maternal quality-adjusted life years (QALYs). Estimation of the incremental cost-effectiveness ratio (ICER), likelihood of cost-effectiveness, and a value of information (VoI) analysis assessing if further research is needed before making a decision about screening. Results: First trimester anomaly screening increased mean per woman costs by £11 (95% CI £1–£29) and maternal QALYs by 0.002065 (95% CI 0.00056–0.00358). The ICER was £5270 per QALY and the probability of cost-effectiveness at a willingness to pay value for a QALY of £20 000, exceeded 95%. VoI analysis showed further research would be unlikely to represent value for money. The protocol would likely lead to a reduction in infant healthcare costs and QALYs. Conclusions: A protocol to screen for eight major structural anomalies during the first trimester appears to represent value for money for the NHS. The opposing implications for mothers and infants, however, raise complex, challenging, and sensitive issues.