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Purpose: The Obesity and Disease Development Sweden (ODDS) study was designed to create a large cohort to study body mass index (BMI), waist circumference (WC) and changes in weight and WC, in relation to morbidity and mortality., Participants: ODDS includes 4 295 859 individuals, 2 165 048 men and 2 130 811 women, in Swedish cohorts and national registers with information on weight assessed once (2 555 098 individuals) or more (1 740 761 individuals), in total constituting 7 733 901 weight assessments at the age of 17-103 years in 1963-2020 (recalled weight as of 1911). Information on WC is available in 152 089 men and 212 658 women, out of whom 108 795 have repeated information on WC (in total 512 273 assessments). Information on morbidity and mortality was retrieved from national registers, with follow-up until the end of 2019-2021, varying between the registers., Findings to Date: Among all weight assessments (of which 85% are objectively measured), the median year, age and BMI (IQR) is 1985 (1977-1994) in men and 2001 (1991-2010) in women, age 19 (18-40) years in men and 30 (26-36) years in women and BMI 22.9 (20.9-25.4) kg/m 2 in men and 23.2 (21.2-26.1) kg/m 2 in women. Normal weight (BMI 18.5-24.9 kg/m 2 ) is present in 67% of assessments in men and 64% in women and obesity (BMI≥30 kg/m 2 ) in 5% of assessments in men and 10% in women. The median (IQR) follow-up time from the first objectively measured or self-reported current weight assessment until emigration, death or end of follow-up is 31.4 (21.8-40.8) years in men and 19.6 (9.3-29.0) years in women. During follow-up, 283 244 men and 123 457 women died., Future Plans: The large sample size and long follow-up of the ODDS Study will provide robust results on anthropometric measures in relation to risk of common diseases and causes of deaths, and novel findings in subgroups and rarer outcomes., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To assess antibiotic prescribing practice and its determinants among outpatient prescriptions dispensed to the elderly population., Design: A prescription-based, cross-sectional study., Setting: Six community chain pharmacies in Asmara, Eritrea., Participants: All outpatient prescriptions dispensed to the elderly population (aged 65 and above) in the six community chain pharmacies in Asmara, Eritrea., Data Collection and Analysis: Data were collected retrospectively, between 16 June 2023 and 16 July 2023. Antibiotic prescribing practice was assessed using the 2023 World Health Organization (WHO) Access, Watch and Reserve (AWaRe) classification system. Descriptive statistics and logistic regression were performed using IBM SPSS (V.26.0). P values less than 0.05 were considered as significant., Results: Of the 2680 outpatient prescriptions dispensed to elderly population, 35.8% (95% CI: 34.0, 37.6) contained at least one antibiotic. Moreover, a total of 1061 antibiotics were prescribed to the elderly population. The most commonly prescribed antibiotics were ciprofloxacin (n=322, 30.3%) and amoxicillin/clavulanic acid (n=145, 13.7%). The Access category accounted for the majority of antibiotics (53.7%) with 32.1% from the Watch category. Prescriber qualification (Adjusted Odds Ratio (AOR)= 0.60, 95% CI: 0.44, 0.81) and polypharmacy (AOR= 2.32, 95% CI: 1.26, 4.27) were significant determinants of antibiotic prescribing in the elderly population. Besides, sex (AOR=0.74, 95% CI: 0.56, 0.98), prescriber qualification (AOR=0.49, 95% CI: 0.30 to0.81) and level of health facility (AOR 0.52, 95% CI 0.34 to 0.81) were significant determinants of a Watch antibiotic prescription., Conclusion: Antibiotics were prescribed to a considerable number of the elderly population, with more than half of them falling into the Access category. Further efforts by policy-makers are needed to promote the use of Access antibiotics while reducing the use of Watch antibiotics to mitigate risks associated with antimicrobial resistance., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: We aimed to use a large dataset to compare self-reported and primary care measures of insomnia symptom prevalence in England and establish whether they identify participants with similar characteristics., Design: Cross-sectional study with linked electronic health records (EHRs)., Setting: Primary care in England., Participants: 163 748 UK Biobank participants in England (aged 38-71 at baseline) with linked primary care EHRs., Outcome Measures: We compared the percentage of those self-reporting 'usually' having insomnia symptoms at UK Biobank baseline assessment (2006-2010) to those with a Read code for insomnia symptoms in their primary care records prior to baseline. We stratified prevalence in both groups by sociodemographic, lifestyle, sleep and health characteristics., Results: We found that 29% of the sample self-reported having insomnia symptoms, while only 6% had a Read code for insomnia symptoms in their primary care records. Only 10% of self-reported cases had an insomnia symptom Read code, while 49% of primary care cases self-reported having insomnia symptoms. In both primary care and self-reported data, prevalence of insomnia symptom cases was highest in females, older participants and those with the lowest household incomes. However, while snorers and risk takers were more likely to be a primary care case, they were less likely to self-report insomnia symptoms than non-snorers and non-risk takers., Conclusions: Only a small proportion of individuals experiencing insomnia symptoms have an insomnia symptom Read code in their primary care record. However, primary care data do provide a clinically meaningful measure of insomnia prevalence. In addition, the sociodemographic characteristics of people attending primary care with insomnia were consistent with those with self-reported insomnia, thus primary care records are a valuable data source for studying risk factors for insomnia. Further studies should replicate our findings in other populations and examine ways to increase discussions about sleep health in primary care., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Objective: This study aimed to assess the administration technique of eye medications, its determinants and disposal practices among ophthalmic outpatients., Design: An analytical cross-sectional study was conducted., Setting: Brhan Aini Ophthalmic National Referral Hospital in Asmara, Eritrea., Participants: Samples of ophthalmic outpatients aged > 18 years who visited Brhan Aini Ophthalmic National Referral Hospital in Asmara, Eritrea. Systematic random sampling was used to select the study participants., Data Collection and Analysis: Data were collected from August 2021 to September 2021, using an interview-based questionnaire. The collected data were entered and analysed using CSPro (V.7.3) and SPSS (V.26), respectively. Descriptive statistics and independent samples t-test were performed. P -values less than 0.05 were considered as significant., Results: A total of 333 respondents with a mean age of 56.4 (SD: 18.76) years were recruited in the study. More than half of the respondents (57.4%) did not have any information on the time interval between two successive eye medications. However, only 16.5% of the respondents managed to close their tear ducts after the administration of eye medication. The mean (SD) score for proper administration of eye medication was 4.16 (1.07) out of 7.0. Female sex (p=0.002), the absence of glaucoma (p=0.035) and the presence of cataract (p=0.014) were significant determinants of the proper administration technique of eye medication. The most favoured disposal practice for unused and/or expired eye medications was disposing of regular garbage (79.9%)., Conclusion: This research revealed that there was an inappropriate administration technique and disposal practices of eye medications among ophthalmic outpatients. This requires immediate attention from policy-makers, programme managers and healthcare professionals to ensure the appropriate use of eye medications by the patients., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The fragmentation of the response to the COVID-19 pandemic at national, regional and local levels is a possible source of variability in the impact of the pandemic on society. This study aims to assess how much of this variability affected the burden of COVID-19, measured in terms of all-cause 2020 excess mortality., Design: Ecological retrospective study., Setting: Lombardy region of Italy, 2015-2020., Outcome Measures: We evaluated the relationship between the intensity of the epidemics and excess mortality, assessing the heterogeneity of this relationship across the 91 districts after adjusting for relevant confounders., Results: The epidemic intensity was quantified as the COVID-19 hospitalisations per 1000 inhabitants. Five confounders were identified through a directed acyclic graph: age distribution, population density, pro-capita gross domestic product, restriction policy and population mobility.Analyses were based on a negative binomial regression model with district-specific random effects. We found a strong, positive association between COVID-19 hospitalisations and 2020 excess mortality (p<0.001), estimating that an increase of one hospitalised COVID-19 patient per 1000 inhabitants resulted in a 15.5% increase in excess mortality. After adjusting for confounders, no district differed in terms of COVID-19-unrelated excess mortality from the average district. Minimal heterogeneity emerged in the district-specific relationships between COVID-19 hospitalisations and excess mortality (6 confidence intervals out of 91 did not cover the null value)., Conclusions: The homogeneous effect of the COVID-19 spread on the excess mortality in the Lombardy districts suggests that, despite the unprecedented conditions, the pandemic reactions did not result in health disparities in the region., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: In older patients, the diagnosis of acute pyelonephritis (APN) is challenging. The aim was to evaluate the added value of CT to history, physical examination and urinalysis for the diagnosis of APN in older patients with suspected infection with an unknown focus., Design: Retrospective diagnostic study., Setting: Department of General Medicine in an acute care hospital in Japan., Participants: Patients aged ≥65 years who underwent blood cultures, a urine culture, and chest and abdominal CT to detect the focus of infection were included., Primary Outcome Measures: Two radiologists independently reviewed four non-contrast CT signs: perirenal fat stranding, pelvicalyceal wall thickening, enlargement of the kidney and thickening of Gerota's fascia. Findings on contrast-enhanced CT could not be evaluated due to an insufficient number of patients in whom contrast-enhanced CT was performed. An expert panel was used as the reference standard for APN. The added value of CT findings was quantified by comparing the diagnostic performance between a model based on 10 predictors available before CT and an extended model including the CT findings., Results: Of 473 patients, 61 (14.8%) were diagnosed with APN. When the laterality of the CT findings was taken into account, the model fit was not improved by adding them. In the laterality-insensitive analysis, the model performance was significantly improved by adding the CT signs (likelihood-ratio test p=0.03; c-index 0.89 vs 0.91, p=0.03). However, their clinical utility was only to improve the classification of 11.5% of patients with APN., Conclusions: The added value of non-contrast CT findings to history, physical examination and urinalysis was limited for the diagnosis of APN in older patients with a suspected infection with an unknown focus., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To assess whether acoustic stimulations relieve venipuncture pain and determine which stimulation is the most effective type., Design: Systematic review and network meta-analysis., Data Sources: PubMed, Cochrane Central Register of Controlled Trials, Excerpta Medica dataBASE, Cumulative Index to Nursing and Allied Health Literature, ClinicalTrials.gov and the International Clinical Trials Registry Platform databases were systematically searched in September 2023., Study Selection: Randomised controlled trials evaluating the efficacy of acoustic stimulations on patients undergoing venipuncture were eligible. Acoustic stimulations were classified into seven categories: five types of acoustic stimulations (music medicine (researcher selected), music medicine (patient selected), music therapy, sounds with linguistic meaning and sounds without linguistic meaning) and two controls (only wearing headphones and no treatment)., Primary and Secondary Outcome Measures: Primary outcomes included self-reported pain intensity assessed during venipuncture and treatment cost, and secondary outcomes were self-reported mental distress and adverse events., Results: Of 6406 citations, this network meta-analysis included 27 studies including 3416 participants; the mean age was 31.5 years, and 57% were men. Among the five types of acoustic stimulations, only musical interventions, such as music medicine (patient selected) (standardised mean difference (SMD) -0.44 (95% CI: -0.84 to -0.03); low confidence), music medicine (researcher selected) (SMD -0.76 (95% CI: -1.10 to -0.42); low confidence) and music therapy (SMD -0.79 (95% CI: -1.44 to -0.14); low confidence), were associated with improved pain relief during venipuncture compared with no treatment. No significant differences existed between the types of acoustic stimulations. Free-of-charge acoustic stimulations were provided to patients, and no specific adverse events were reported. In many studies, the risk of bias was rated high because of the difficulty of blinding the intervention to the participants and the self-reported pain outcome., Conclusions: Music interventions were associated with reduced venipuncture pain. Comparisons between types of acoustic stimulations revealed no significant differences. Therefore, music intervention could be a safe and inexpensive pain relief method for venipuncture., Prospero Registration Number: CRD42022303852., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Hyperkalaemia (HK) is a frequent complication in patients with chronic kidney disease (CKD) and/or chronic heart failure (CHF). HK must be managed, both to protect patients from its direct clinical adverse outcomes and to enable treatment with disease-modifying therapies including renin-angiotensin-aldosterone system inhibitors. However, the experiences of patients undergoing treatment of HK are not clearly understood. Optimising treatment decisions and improving long-term patient management requires a better understanding of patients' quality of life (QOL). Thus, the aims of this research are: (1) to describe treatment patterns and the impact of treatment on a patient's QOL, (2) to study the relationships between treatment patterns and the impact of treatment on a patient's QOL and (3) to study the relationships between the control of serum potassium (S-K) and the impact of treatment on a patient's QOL, in patients with HK., Methods and Analysis: This is a prospective cohort study with 6 months of follow-up in 30-40 outpatient nephrology and cardiology clinics in Japan. The participants will be 350 patients with CKD or CHF who received their first potassium binders (PB) prescription to treat HK within the previous 6 months. Medical records will be used to obtain information on S-K, on treatment of HK with PBs and with diet, and on the patients' characteristics. To assess the impact of treatment on a patient's QOL, questionnaires will be used to obtain generic health-related QOL, CKD-specific and CHF-specific QOL, and PB-specific QOL. Multivariable regression models will be used to quantify how treatment patterns and S-K control are related to the impact of treatment on a patient's QOL., Ethics and Dissemination: Institutional review boards at all participating facilities review the study protocol. Patient consent will be obtained. The results will be published in international journals., Trial Registration Number: NCT05297409., Competing Interests: Competing interests: TW and YY have consulted for the Institute for Health Outcomes and Process Evaluation research. Under a contract with Kyoto University, consultation fees by HY and SF were paid to Kyoto University from Takeda Pharmaceutical Company Limited and Magmitt Pharmaceutical Company. JW and YO are employees of the Institute for Health Outcomes & Process Evaluation research. TY is an employee and a stock holder of AstraZeneca K.K. JEW are has received consulting fees from AstraZeneca K.K. YS has received honoraria from AstraZeneca K.K., Otsuka Pharma Co., and Kyowa Kirin Co. HY has received lecture fee from Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma, Kowa Company Limited, AstraZeneka K.K., and Takeda Pharmaceutical Company Limited. K-ES is a member of the speakers’ bureau of Glaxo Smith Kline K.K. YY has received consultancy fees from Nippon Shinyaku Co, and personal fees from Sun Pharma, Asahi Kasei Pharma, TORAY, and Ono, outside the submitted work., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Gonadotropin-releasing hormone agonists (GnRHa) cotreatment used to transiently suppress ovarian function during chemotherapy to prevent ovarian damage and preserve female fertility is used globally but efficacy is debated. Most clinical studies investigating a beneficial effect of GnRHa cotreatment on ovarian function have been small, retrospective and uncontrolled. Unblinded randomised studies on women with breast cancer have suggested a beneficial effect, but results are mixed with lack of evidence of improvement in markers of ovarian reserve. Unblinded randomised studies of women with lymphoma have not shown any benefit regarding fertility markers after long-term follow-up and no placebo-controlled study has been conducted so far. The aim of this study is to investigate if administration of GnRHa during cancer treatment can preserve fertility in young female cancer patients in a double-blind, placebo-controlled clinical trial., Methods and Analysis: A prospective, randomised, double-blinded, placebo-controlled, phase III study including 300 subjects with breast cancer. In addition, 200 subjects with lymphoma, acute leukemias and sarcomas will be recruited. Women aged 14-42 will be randomised 1:1 to treatment with GnRHa (triptorelin) or placebo for the duration of their gonadotoxic chemotherapy. Follow-up until 5 years from end of treatment (EoT). The primary endpoint will be change in anti-Müllerian hormone (AMH) recovery at follow-up 12 months after EoT, relative to AMH levels at EoT, comparing the GnRHa group and the placebo group in women with breast cancer., Ethics and Dissemination: This study is designed in accordance with the principles of Good Clinical Practice (ICH-GCP E6 (R2)), local regulations (ie, European Directive 2001/20/EC) and the ethical principles of the Declaration of Helsinki. Within 6 months of study completion, the results will be analysed and the study results shall be reported in the EudraCT database., Study Registration: The National Institutional review board in Sweden dnr:2021-03379, approval date 12 October 2021 (approved amendments 12 June 2022, dnr:2022-02924-02 and 13 December 2022, dnr:2022-05565-02). The Swedish Medical Product Agency 19 January 2022, Dnr:5.1-2021-98927 (approved amendment 4 February 2022). Manufacturing authorisation for authorised medicinal products approved 6 December 2021, Dnr:6.2.1-2020-079580. Stockholm Medical Biobank approved 22 June 2022, RBC dnr:202 253., Trial Registration Number: NCT05328258; EudraCT number:2020-004780-71., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Objectives: To explore the risk of being prescribed/dispensed medications for respiratory symptoms and breathing difficulties in children with and without congenital anomalies., Design: A EUROlinkCAT population-based data linkage cohort study. Data on children with and without congenital anomalies were linked to prescription databases to identify children who did/did not receive antiasthmatic prescriptions. Data were analysed by age, European region, class of antiasthmatic, anomaly, sex, gestational age and birth cohort., Setting: Children born 2000-2014 in six regions within five European countries., Participants: 60 662 children with congenital anomalies and 1 722 912 reference children up to age 10 years., Primary Outcome Measure: Relative risks (RR) of >1 antiasthmatic prescription in a year, identified using Anatomical Therapeutic Chemical classification codes beginning with R03., Results: There were significant differences in the prescribing of antiasthmatics in the six regions. Children with congenital anomalies had a significantly higher risk of being prescribed antiasthmatics (RR 1.41, 95% CI 1.35 to 1.48) compared with reference children. The increased risk was consistent across all regions and all age groups. Children with congenital anomalies were more likely to be prescribed beta-2 agonists (RR 1.71, 95% CI 1.60 to 1.83) and inhaled corticosteroids (RR 1.74, 95% CI 1.61 to 1.87). Children with oesophageal atresia, genetic syndromes and chromosomal anomalies had over twice the risk of being prescribed antiasthmatics compared with reference children. Children with congenital anomalies born <32 weeks gestational age were over twice as likely to be prescribed antiasthmatics than those born at term (RR 2.20, 95% CI 2.10 to 2.30)., Conclusion: This study documents the additional burden of respiratory symptoms and breathing difficulties for children with congenital anomalies, particularly those born preterm, compared with children without congenital anomalies in the first 10 years of life. These findings are beneficial to clinicians and healthcare providers as they identify children with greater morbidity associated with respiratory symptoms, as indicated by antiasthmatic prescriptions., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: In Sweden, as in many other countries, official monitoring of healthcare quality is mostly focused on geographical disparities in relation to a desirable benchmark. However, current evaluations could be improved by considering: (1) The intersection of other relevant axes of inequity like age, sex, income and migration status; and (2) The existence of individual heterogeneity around averages. Therefore, using an established quality indicator (ie, dispensation of statins after acute myocardial infarction, AMI), we valuate both geographical and sociodemographic inequalities and illustrate how the analysis of individual heterogeneity and discriminatory accuracy (AIHDA) enhances such evaluations., Population and Methods: We applied AIHDA and calculated the area under the receiver operating characteristics curve (AUC) of regional and sociodemographic differences in the statin dispensations of 35 044 patients from 21 Swedish regions and 24 sociodemographic strata who were discharged from the hospital with an AMI diagnosis between January 2011 and December 2013. Following the Swedish National Board of Health and Welfare, we used a benchmark value of 90%., Results: Dispensation of stains after AMI in Sweden did not reach the desired target of 90%. Regional differences were absent/very small (AUC=0.537) while sociodemographic differences were small (AUC=0.618). Women, especially those with immigrant background and older than 65 years, have the lowest proportions of statin dispensations after AMI., Conclusions: As the AUC statistics are small, interventions trying to achieve the benchmark value should be universal. However, special emphasis should nevertheless be directed towards women, especially older women with immigrant backgrounds., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Background: Studies assessing the indirect impact of COVID-19 using mathematical models have increased in recent years. This scoping review aims to identify modelling studies assessing the potential impact of disruptions to essential health services caused by COVID-19 and to summarise the characteristics of disruption and the models used to assess the disruptions., Methods: Eligible studies were included if they used any models to assess the impact of COVID-19 disruptions on any health services. Articles published from January 2020 to December 2022 were identified from PubMed, Embase and CINAHL, using detailed searches with key concepts including COVID-19, modelling and healthcare disruptions. Two reviewers independently extracted the data in four domains. A descriptive analysis of the included studies was performed under the format of a narrative report., Results: This scoping review has identified a total of 52 modelling studies that employed several models (n=116) to assess the potential impact of disruptions to essential health services. The majority of the models were simulation models (n=86; 74.1%). Studies covered a wide range of health conditions from infectious diseases to non-communicable diseases. COVID-19 has been reported to disrupt supply of health services, demand for health services and social change affecting factors that influence health. The most common outcomes reported in the studies were clinical outcomes such as mortality and morbidity. Twenty-five studies modelled various mitigation strategies; maintaining critical services by ensuring resources and access to services are found to be a priority for reducing the overall impact., Conclusion: A number of models were used to assess the potential impact of disruptions to essential health services on various outcomes. There is a need for collaboration among stakeholders to enhance the usefulness of any modelling. Future studies should consider disparity issues for more comprehensive findings that could ultimately facilitate policy decision-making to maximise benefits to all., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Clinical guidelines for acute non-specific low back pain (LBP) recommend avoiding imaging studies or invasive treatments and to advise patients to stay active. The aim of this study was to evaluate the management of acute non-specific LBP in the emergency departments (ED)., Setting: We invited all department chiefs of Swiss EDs and their physician staff to participate in a web-based survey using two clinical case vignettes of patients with acute non-specific LBP presenting to an ED. In both cases, no neurological deficits or red flags were present. Guideline adherence and low-value care was defined based on current guideline recommendations., Results: In total, 263 ED physicians completed at least one vignette, while 212 completed both vignettes (43% residents, 32% senior/attending physicians and 24% chief physicians). MRI was considered in 31% in vignette 1 and 65% in vignette 2. For pain management, non-steroidal anti-inflammatory drugs, paracetamol and metamizole were mostly used. A substantial proportion of ED physicians considered treatments with questionable benefit and/or increased risk for adverse events such as oral steroids (vignette 1, 12% and vignette 2, 19%), muscle relaxants (33% and 38%), long-acting strong opioids (25% and 33%) and spinal injections (22% and 43%). Although guidelines recommend staying active, 72% and 67% of ED physicians recommended activity restrictions., Conclusion: Management of acute non-specific LBP in the ED was not in agreement with current guideline recommendations in a substantial proportion of ED physicians. Overuse of imaging studies, the use of long-acting opioids and muscle relaxants, as well as recommendations for activity and work restrictions were prevalent and may potentially be harmful., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Linking healthcare data sets can create valuable resources for research, particularly when investigating rare exposures or outcomes. However, across Europe, the permissions processes required to access data can be complex. This paper documents the processes required by the EUROlinkCAT study investigators to research the health and survival of children with congenital anomalies in Europe., Methods: Eighteen congenital anomaly registries in 14 countries provided information on all the permissions required to perform surveillance of congenital anomalies and to link their data on live births with available vital statistics and healthcare databases for research. Small number restrictions imposed by data providers were also documented., Results: The permissions requirements varied substantially, with certain registries able to conduct congenital anomaly surveillance as part of national or regional healthcare provision, while others were required to obtain ethics approvals or informed consent. Data linkage and analysis for research purposes added additional layers of complexity for registries, with some required to obtain several permissions, including ethics approvals to link the data. Restrictions relating to small numbers often resulted in a registry's data on specific congenital anomalies being unusable., Conclusion: The permissions required to obtain and link data on children with congenital anomalies varied greatly across Europe. The variation and complexity present a significant obstacle to the use of such data, especially in large data linkage projects. Furthermore, small number restrictions severely limited the research that could be performed for children with specific rare congenital anomalies., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Although interest in including non-randomised studies of interventions (NRSIs) in meta-analysis of randomised controlled trials (RCTs) is growing, estimates of effectiveness obtained from NRSIs are vulnerable to greater bias than RCTs. The objectives of this study are to: (1) explore how NRSIs can be integrated into a meta-analysis of RCTs; (2) assess concordance of the evidence from non-randomised and randomised trials and explore factors associated with agreement; and (3) investigate the impact on estimates of pooled bodies of evidence when NRSIs are included., Methods and Analysis: We will conduct a systematic survey of 210 systematic reviews that include both RCTs and NRSIs, published from 2017 to 2022. We will randomly select reviews, stratified in a 1:1 ratio by Core vs non-Core clinical journals, as defined by the National Library of Medicine. Teams of paired reviewers will independently determine eligibility and abstract data using standardised, pilot-tested forms. The concordance of the evidence will be assessed by exploring agreement in the relative effect reported by NRSIs and RCT addressing the same clinical question, defined as similarity of the population, intervention/exposure, control and outcomes. We will conduct univariable and multivariable logistic regression analyses to examine the association of prespecified study characteristics with agreement in the estimates between NRSIs and RCTs. We will calculate the ratio of the relative effect estimate from NRSIs over that from RCTs, along with the corresponding 95% CI. We will use a bias-corrected meta-analysis model to investigate the influence on pooled estimates when NRSIs are included in the evidence synthesis., Ethics and Dissemination: Ethics approval is not required. The findings of this study will be disseminated through peer-reviewed publications, conference presentations and condensed summaries for clinicians, health policymakers and guideline developers regarding the design, conduct, analysis, and interpretation of meta-analysis that integrate RCTs and NRSIs., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Despite implementing hepatitis B immunoglobulin (HBIG) and vaccination, data suggest it would not be sufficient to reach the elimination targets. Tenofovir disoproxil fumarate (TDF) has been added to the Thai national standards of care for prevention of transmission of the hepatitis B virus during birth. To optimise national strategies in Thailand, we assessed TDF's effectiveness for prevention of mother-to-child transmission and conducted cost-effectiveness analyses of different TDF-based strategies., Research Design and Methods: We retrospectively reviewed medical records of mother and infant pairs whose mothers were positive for hepatitis B e-antigen (HBeAg) and received TDF to prevent maternal transmission of viral hepatitis B during 2018-2020. Based on the available data on transmission rate, we also applied a decision tree to estimate the cost-effectiveness of different TDF-based strategies to eligible mothers. These included: (1) HBIG for all hepatitis B virus (HBV) exposed infants; (2) HBIG for only infants of HBeAg-positive mothers ('HBIG for e-positive') and (3) without HBIG to infants ('HBIG-free'). The incremental cost-effectiveness ratio between the different strategies and baseline intervention without TDF was calculated. The one-way sensitivity analysis was used to adjust prevalence of HBeAg-positive mothers, cost of HBIG, cost of TDF and transmission rate., Results: Of 223 infants enrolled, 212 (95.0%) received HBIG, while 11 (5.0%) did not. None of the infants had chronic HBV infection. The most cost-saving intervention was 'HBIG-free' followed by 'HBIG for e-positive'. The one-way sensitivity demonstrated that the results were reasonably robust to changes. The cost-saving was greater with a higher hepatitis B virus surface antigen (HBsAg) prevalence. The HBIG-free strategy remained best at 0%-1.4% transmission rates, meeting the additional target for eliminations., Conclusion: The study is the first cost-effectiveness analyses to provide evidence supporting an HBIG-free strategy in an antiviral era. This approach should be considered to prevent mother-to-child transmission in resource-constrained settings, particularly in countries with a high HBsAg prevalence., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: This study compares the use of sickness absence benefits (SABs) due to a common mental disorder (CMD) between precariously employed and non-precariously employed workers with CMDs., Design: Register-based cohort study., Participants: The study included 78 215 Swedish workers aged 27-61 who experienced CMDs in 2017, indicated by a new treatment with selective serotonin reuptake inhibitors (SSRIs). Excluded were those who emigrated or immigrated, were self-employed, had an annual employment-based income <100 Swedish Krona, had >90 days of unemployment per year, had student status, had SABs due to CMDs during the exposure measurement (2016) and the two previous years, had an SSRI prescription 1 year or less before the start of the SSRI prescription in 2017, had packs of >100 pills of SSRI medication, had a disability pension before 2017, were not entitled to SABs due to CMDs in 2016, and had no information about the exposure., Outcome: The first incidence of SABs due to CMDs in 2017., Results: The use of SABs due to a CMD was slightly lower among precariously employed workers compared with those in standard employment (adjusted OR [aOR] 0.92, 95% CI 0.81 to 1.05). Particularly, women with three consecutive years in precarious employment had reduced SABs use (aOR 0.48, 95% CI 0.26 to 0.89), while men in precarious employment showed weaker evidence of association. Those in standard employment with high income also showed a lower use of SABs (aOR 0.74, 95% CI 0.67 to 0.81). Low unionisation and both low and high-income levels were associated with lower use of SABs, particularly among women., Conclusions: The study indicates that workers with CMDs in precarious employment may use SABs to a lower extent. Accordingly, there is a need for (1) guaranteeing access to SABs for people in precarious employment and/or (2) reducing involuntary forms of presenteeism., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Objective: Ceramides have been associated with several ageing-related conditions but have not been studied as a general biomarker of multimorbidity (MM). Therefore, we determined whether ceramide levels are associated with the rapid development of MM., Design: Retrospective cohort study., Setting: Mayo Clinic Biobank., Participants: 1809 persons in the Mayo Clinic Biobank ≥65 years without MM at the time of enrolment, and with ceramide levels assayed from stored plasma., Primary Outcome Measure: Persons were followed for a median of 5.7 years through their medical records to identify new diagnoses of 20 chronic conditions. The number of new conditions was divided by the person-years of follow-up to calculate the rate of accumulation of new chronic conditions., Results: Higher levels of C18:0 and C20:0 were associated with a more rapid rate of accumulation of chronic conditions (C18:0 z score RR: 1.30, 95% CI: 1.10 to 1.53; C20:0 z score RR: 1.26, 95% CI: 1.07 to 1.49). Higher C18:0 and C20:0 levels were also associated with an increased risk of hypertension and coronary artery disease., Conclusions: C18:0 and C20:0 were associated with an increased risk of cardiometabolic conditions. When combined with biomarkers specific to other diseases of ageing, these ceramides may be a useful component of a biomarker panel for predicting accelerated ageing., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Multimorbidity is defined as the coexistence of two or more chronic physical or psychological conditions within an individual. The association between maternal multimorbidity and adverse perinatal outcomes such as preterm delivery and low birth weight has not been well studied. Therefore, this study aimed to investigate this association., Methods: We conducted a prospective cohort study using data from the Japan Environment and Children's Study of pregnant women between 2011 and 2014. Those with data on chronic maternal conditions were included in the study and categorised as having no chronic condition, one chronic condition or multimorbidities. The primary outcomes were the incidence of preterm birth (PTB), low birth weight (LBW) and small for gestational age (SGA). Adjusted logistic regression was performed to estimate ORs (aORs) and 95% CIs., Results: Of the 104 062 fetal records, 86 885 singleton pregnant women were analysed. The median maternal age and body mass index were 31 years and 20.5 kg/m 2 , respectively. The prevalence of pregnant women with one or more chronic conditions was 40.2%. The prevalence of maternal multimorbidity was 6.3%, and that of PTB, LBW, and SGA were 4.6%, 8.1%, and 7.5%, respectively. Pre-pregnancy underweight women were the most common, observed in 15.6% of multimorbidity cases, followed by domestic violence from intimate partner in 13.0%. Maternal multimorbidity was significantly associated with PTB (aOR 1.50; 95% CI 1.33-1.69), LBW (aOR 1.49; 95% CI 1.35-1.63) and SGA (aOR 1.33; 95% CI 1.20-1.46)., Conclusion: Maternal multimorbidity was associated with adverse perinatal outcomes, including PTB, LBW and SGA. The risk of adverse perinatal outcomes tends to increase with a rise in the number of chronic maternal conditions. Multimorbidity becomes more prevalent among pregnant women, making our findings important for preconception counselling., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: A cross-sectional and a policy document review study was performed to investigate perceived acceptability and feasibility to implementing different integration measures for tuberculosis (TB) and diabetes mellitus (DM) healthcare among healthcare workers (HCWs) and health managers, and to describe policy influence through a policy documents review in Malawi., Setting: The survey was performed at eight hospitals, ministry of health offices and 10 non-governmental organisations. We collected data in March and April 2021., Participants: Of 95 HCWs and health managers invited; 92 participated. 21/92 (23%) were female, and 17/92 (18%) participants were from clinics that piloted the integrated care for TB and DM., Outcome Measures: We described awareness levels on TB/DM comorbidity, perceptions and experiences in TB/DM care. Furthermore, development processes and contents of included documents were analysed., Results: 16/17 (94%) of HCWs from clinics piloting integrated care and 65/75 (86%) HCWs from hospitals that do not use integrated care for TB and DM responded that integrated care was acceptable and feasible. In qualitative data, shortage of resources, inadequate information sharing were common themes. We included seven relevant documents for the analysis. On development process and content, six of seven documents were scored ≥70%. In these documents, DM is a recognised risk factor for TB, and integration of healthcare services for infectious diseases and non-communicable diseases is recommended, however, these documents lacked information specifically on integrated care for TB and DM., Conclusion: In this study, we identified inadequate information sharing, and lack of resources as major factors impeding implementation of integration of services, however, awareness on TB/DM comorbidity was high., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Daily COVID-19 data reported by WHO may provide the basis for political ad hoc decisions including travel restrictions. Data reported by countries, however, are heterogeneous and metrics to evaluate its quality are scarce. In this work, we analysed COVID-19 case counts provided by WHO and developed tools to evaluate country-specific reporting behaviours., Methods: In this retrospective cross-sectional study, COVID-19 data reported daily to WHO from 3 January 2020 until 14 June 2021 were analysed. We proposed the concepts of binary reporting rate and relative reporting behaviour and performed descriptive analyses for all countries with these metrics. We developed a score to evaluate the consistency of incidence and binary reporting rates. Further, we performed spectral clustering of the binary reporting rate and relative reporting behaviour to identify salient patterns in these metrics., Results: Our final analysis included 222 countries and regions. Reporting scores varied between -0.17, indicating discrepancies between incidence and binary reporting rate, and 1.0 suggesting high consistency of these two metrics. Median reporting score for all countries was 0.71 (IQR 0.55-0.87). Descriptive analyses of the binary reporting rate and relative reporting behaviour showed constant reporting with a slight 'weekend effect' for most countries, while spectral clustering demonstrated that some countries had even more complex reporting patterns., Conclusion: The majority of countries reported COVID-19 cases when they did have cases to report. The identification of a slight 'weekend effect' suggests that COVID-19 case counts reported in the middle of the week may represent the best data basis for political ad hoc decisions. A few countries, however, showed unusual or highly irregular reporting that might require more careful interpretation. Our score system and cluster analyses might be applied by epidemiologists advising policy makers to consider country-specific reporting behaviours in political ad hoc decisions., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: An easy-to-access and effective psychotherapy for bereaved informal caregivers has not been established. People with higher self-compassion status tend to have lower bereavement related grief, psychotherapy focused on self-compassion can be promising for this population. This study aimed to examine the feasibility of online self-compassion focused psychotherapy for bereaved informal caregivers., Method and Analysis: A total of 60 study participants will undergo an intervention programme comprising online sessions of 2 hours per week for five consecutive weeks and undertake postsession work. The intervention personnel will comprise psychologists who have received more than 10 hours of structured training. The primary endpoint will be assessed on the intervention completion rate, with secondary endpoints consisting of the Complicated Grief Questionnaire, Patient Health Questionnaire-9, Generalised Anxiety Disorder-7, Brief Resilience Scale and Self-Compassion Scale. Evaluations will be conducted preintervention, immediately after intervention, and 4 and 12 weeks after intervention., Ethics and Dissemination: This study has been reviewed and approved by the Ethics Committee of the Kyoto University Graduate School and Faculty of Medicine, Kyoto University Hospital, Japan (Approved ID: C1565). The results of this study will be disseminated through publication in a peer-reviewed journal and conference presentations., Trial Registration Number: UMIN000048554., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To evaluate comanagement with rheumatology and biological prescriptions filled during pregnancy among women with axial spondyloarthritis (axSpA), rheumatoid arthritis (RA) or psoriatic arthritis (PsA) and to examine factors associated with receiving comanagement with rheumatology during pregnancy., Design: A retrospective analysis of US claims data., Setting: Commercially insured enrollees using data from the 2013-2018 IBM MarketScan Commercial Claims and Encounters Database., Participants: We identified 4131 pregnant women aged ≤55 years from the 2013-2018 IBM MarketScan Commercial Claims and Encounters Database with an International Classification of Disease, 9th Revision/10th Revision codes for RA, axSpA or PsA, with continuous enrolment at ≥3 months before the date of the last menstrual period (LMP) (index date) and throughout pregnancy., Primary Outcomes: Filled biologics (prescriptions and infusions) claims were categorised by 90 days before the LMP and trimester, as were primary care, obstetrician and rheumatological claims., Results: The prevalence of axSpA, RA and PsA was 0.7%, 0.2% and 0.04% among reproductive age women. The average maternal age was 32.7 years (SD 5.7). During pregnancy, 9.1% of those with axSpA (n=2,410) and 56.4% of those with RA/PsA (n=1,721) had a rheumatological claim. Biologics claims were less common among those with axSpA (90 days before LMP: 1.6%, during pregnancy: 1.1%) than those with RA/PsA (90 days before LMP: 11.9%, during pregnancy: 6.9%). Medications during pregnancy included corticosteroids (axSpA: 0.3%, RA/PsA: 2.2%), non-biological disease-modifying antirheumatic drugs (axSpA: 0.2%, RA/PsA: 1.7%), non-steroidal anti-inflammatory drugs (axSpA: 0.2%, RA/PsA: 1.3%) and opioids (axSpA: 0.2%, RA/PsA: 0.6%). Established rheumatological care and biologics claims during the 90 days before LMP showed good prediction accuracy for receiving comanagement with rheumatology during pregnancy (axSpA: area under the receiver operator curve (AUC) 0.73, RA/PsA: AUC 0.70)., Conclusion: Comanagement with rheumatology during pregnancy occurs infrequently, especially for women with axSpA. Biologics claims during pregnancy may not align with published guidelines. Future research is warranted to improve comanagement with rheumatology during pregnancy., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To reduce sickness absence (SA) and increase work participation, the tripartite Agreement for a More Inclusive Working Life (IA) was established in Norway in 2001. IA companies have had access to several measures to prevent and reduce SA. Our aim in this paper was to estimate the average effect of having access to IA at the time of entering a first SA on later return-to-work (RTW) and on time spent in other work-related states. A secondary objective was to study how effects varied between women and men, and individuals with SA due to either musculoskeletal or psychological diagnoses., Design: Population-based observational multistate longitudinal cohort study., Setting: Individual characteristics and detailed longitudinal records of SA, work and education between 1997-2011 were obtained from population-wide registries., Participants: Each individual born in Norway 1967-1976 who entered full-time SA during 2004-2011, with limited earlier SA, was included (n=187 930)., Primary and Secondary Outcome Measures: Individual multistate histories containing dated periods of work, graded SA, full-time SA, non-employment and education., Methods: Data were analysed in a multistate model with 500 days of follow-up. The effect of IA was assessed by estimating differences in state probabilities over time, adjusted for confounders, using inverse probability weighting., Results: IA increased the probability of work after SA, with the largest difference between groups after 29 days (3.4 percentage points higher (95% CI 2.5 to 4.3)). Differences in 1-year expected length of stay were 8.4 additional days (4.9 to 11.9) in work, 7.6 (4.8 to 10.3) fewer days in full-time SA and 1.6 (-0.2 to 3.4) fewer days in non-employment. Similar trends were found within subgroups by sex, musculoskeletal and psychological diagnoses. The robustness of the findings was studied in sensitivity analyses., Conclusion: Measures to prevent and reduce SA, as given through IA, were found to improve individuals' RTW after entering SA., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Objective: To assess the prevalence and practice of self-medication and its associated factors among ophthalmic patients., Design: An analytical cross-sectional study design was employed., Setting: Three hospitals inAsmara, Eritrea., Participants: Samples of ophthalmic outpatients aged >18 years who visited the three hospitals in Asmara, Eritrea. Systematic random sampling was used to select the study participants., Data Collection and Analysis: Data were collected from September 2021 to October 2021 in a face-to-face interview using a structured questionnaire. The collected data were double entered and analysed using CSPro (V.7.2) and SPSS (V.26), respectively. Descriptive statistics and logistic regression were performed. P values less than 0.05 were considered as significant., Primary and Secondary Outcome Measures: Main outcome variable was practice of self-medication with ophthalmic drugs (SMOD). Secondary outcome measure was the determinants of self-medication practice., Results: A total of 351 participants were recruited with a response rate of 97.7%. The prevalence of SMOD was found to be 14.9% (95% CI (11.1% to 18.7%)). The most frequently preferred ophthalmic drug groups were antibiotics (63.6%), followed by corticosteroids (22.7%). The main reasons for SMOD were easy accessibility (52.9%) and previous familiarity of the eye medication (27.5%). Eye redness (n=19/51) and foreign body sensation (n=18/51) were the most self-recognised complaints that required self-medication. The most common source of information for SMOD was pharmacy professionals (41.1%). Only attitude score (Crude odds ratio (COR)= 1.25, 95% CI 1.12, 1.39) was significantly associated with the practice of SMOD at bivariate logistic regression., Conclusion: Though the majority of respondents considered self-medication with ophthalmic drugs as inappropriate, a significant number of them practising it. This mandates relevant bodies to take stricter measures to protect the public from the misuse of eye medications., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Elevated baseline serum alkaline phosphatase (ALP) may correlate with higher medium-term to long-term mortality in the general population and in patients with chronic kidney disease. However, few data are available on the association between serum ALP and the short-term prognosis of patients on haemodialysis (HD). We verified the association of ALP levels and bacteraemia or death in maintenance HD patients suspected of bacteraemia in an outpatient setting., Design: We analysed 315 consecutive HD patients suspected of having bacteraemia with two sets of blood culture drawn on admission., Setting: Admission to two tertiary-care university medical centres from January 2013 to December 2015., Participants: Consecutive cases on maintenance HD aged≥18 years. Cases of hospitalised patients who had been transferred from another hospital, had a dialysis vintage<2 months, were also undergoing peritoneal dialysis, and/or were receiving HD less than once a week were excluded., Primary and Secondary Outcome Measures: Primary outcome measure was bacteraemia and secondary outcome was in-hospital death., Results: Among 315 cases included in the study, 187 had baseline-measured ALP levels, with a cut-off value on ROC analysis of 360 U/L (Area Under the Curve (AUC) 0.60, sensitivity 0.49, specificity 0.76). In multivariate analysis, there was a statistically significant association between a higher ALP in hospital visit and bacteraemia (OR: 2.37, 95% CI: 1.17 to 4.83). However, there were no statistically significant associations between higher ALP and in-hospital death (OR: 1.20, 95% CI: 0.57 to 2.54). A sensitivity analysis of 187 patients with no missing ALP values also demonstrated a significant association between elevated ALP and bacteraemia, but no significant association between ALP and in-hospital death., Conclusions: Elevated ALP is a predictor of bacteraemia. In HD patients suspected of bacteraemia in outpatient settings, increased ALP levels were associated with increased likelihood of confirmed disease., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Psychology students at universities in Denmark and worldwide often receive relatively little clinical training, even though such training is crucial to job performance after graduation. Training common psychotherapeutic skills, such as being empathic and facilitating the therapeutic alliance, is critical since these skills are related to psychotherapy outcomes. In this study, a deliberate practice-based approach to student training will be compared with theoretical teaching. The main hypothesis is that deliberate practice training will result in a larger improvement in students' observer-rated interpersonal skills., Methods and Analysis: The TRaining of graduate students In general Psychotherapeutic Skills study has a double-centre, randomised, assessor-blinded, two-way crossover study design. About 200 graduate students from two Danish universities will be randomised into two groups, (a) deliberate practice training of common psychotherapeutic skills using role-play and Skillsetter, an online skill-building system with therapy videos or (b) theoretical teaching. Group a will first receive the experimental condition, followed by the control condition, while group b will receive the conditions in reverse order. Each condition consists of 15 hours of classroom participation and homework. The primary outcome is facilitative interpersonal skills-observer. Secondary outcomes include the facilitative interpersonal skills-self-report, the Counselor Activity Self-Efficacy Scales and the Interpersonal Reactivity Index. Outcomes will be measured at baseline (week 0), after the first condition (week 5; before the crossover, reflecting true randomisation) and after both conditions (week 10). Main outcome analyses will be performed at week 5. Several predictors of the effect of deliberate practice will be explored., Ethics and Dissemination: Ethical approval from university ethics boards has been obtained. All participants will be asked to provide informed consent before participation. Once completed, the study can potentially transform the training of psychotherapy in graduate education, which, ultimately, may positively influence psychotherapy outcomes (IP-IRB / 03092021)., Trial Registration Number: NCT05164497., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Chemotherapy-induced peripheral neuropathy is a frequent side effect of some chemotherapies that can cause postural control disorders and has a serious impact on quality of life (QoL). An enhanced understanding of postural control dysfunction could help build a systematic and accurate assessment as well as specific exercises to limit the impact on QoL. This study aims to assess the influence of chemotherapy on postural control and the QoL for women with gynaecological cancer., Methods and Analysis: This prospective observational study will include 37 participants with cancer treated using neurotoxic chemotherapy. Their postural control in various conditions (rigid and foam surfaces, eyes open and closed, with and without tendon vibration, and dual tasks), limits of stability, QoL and modified Total Neuropathy Score will be assessed. A linear mixed model will compare postural control pre-chemotherapy and post-chemotherapy., Ethics and Dissemination: This study was approved by an ethical review board in Geneva (CCER-2020-01639). The study findings will be disseminated through conference presentations and publications in peer-reviewed journals., Trial Registration Number: NCT04692168., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Evaluating the quality of dying and death is essential to ensure high-quality end-of-life care. The Quality of Dying and Death (QODD) scale is the best-validated measure of the construct, but many items are not relevant to participants, particularly in low-resource settings. The aim of this multisite cross-sectional study is to develop and validate the QODD-Revised Global Version (QODD-RGV), to enhance ease of completion and relevance in higher-resource and lower-resource settings., Methods and Analysis: This study will be a two-arm, multisite evaluation of the cultural relevance, reliability and validity of the QODD-RGV across four participating North American hospices and a palliative care site in Malawi, Africa. Bereaved caregivers and healthcare providers of patients who died at a participating North American hospice and bereaved caregivers of patients who died of cancer at the Malawian palliative care site will complete the QODD-RGV and validation measures. Cognitive interviews with subsets of North American and Malawian caregivers will assess the perceived relevance of the scale items. Psychometric evaluations will include internal consistency and convergent and concurrent validity., Ethics and Dissemination: The North American arm received approval from the University Health Network Research Ethics Board (21-5143) and the University of North Carolina Institutional Review Board (21-1172). Ethics approval for the Malawi arm is being obtained from the University of North Carolina Institutional Review Board and the Malawian National Health Science Research Committee. Study findings will be disseminated through publication in peer-reviewed journals and conference presentations., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Although previous studies have investigated the role of religiosity in violence outcomes, there is a lack of studies including this aspect as a mediator for violence in childhood and adulthood. This study aimed to investigate the relationship between religiosity and violence in childhood, as well as the possible mediating role of religiosity between suffering violence in childhood and suffering and/or perpetrating violence in adulthood., Design: Cross-sectional population-based study carried out from November 2011 to March 2012., Setting: Face-to-face surveys (at participants' homes) were performed in a Brazilian nationally representative sample., Participants: A total of 3378 adults (aged 19 years and above) were included., Primary and Secondary Outcomes Measures: The association between suffering violence in childhood and religiosity, and the mediating role of religiosity between childhood and adulthood violence were analysed using logistic regression models., Results: Religiosity was associated with childhood violence, showing that those who suffered less violence in childhood were more religious in adulthood and considered religion more important in their lives. However, while there was a significant association between suffering violence during childhood and suffering and/or perpetrating violence in adulthood, religiosity did not mediate this relationship., Conclusions: Although religious individuals self-reported less violence suffered in childhood, religiosity did not show evidence of being a potential mediator for childhood and adulthood violence (experienced and/or perpetrated). These results could help researchers explore this phenomenon, and aid health professionals and managers when proposing future interventions., Competing Interests: Competing interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: This study aims to examine sociodemographic characteristics and health access associated with COVID-19 infection and death in Malang District, Indonesia., Design: A non-random cross-sectional study., Setting: Population in 390 villages in Malang District, East Java Province, Indonesia., Participants: We used Malang District government COVID-19 contact tracing data from 14 264 individuals, spanning from 1 March 2020 to 29 July 2020., Primary Outcome Measures: The outcome variables in this study are COVID-19 infections and COVID-19 deaths. The associations between sociodemographic characteristics and health access of COVID-19 infection and death were analysed using multilevel logistic regression., Results: Among the 14 264 samples, 551 individuals were confirmed as being infected with COVID-19; 62 individuals died of COVID-19. Women, individuals with direct contact with confirmed COVID-19 cases and individuals with hypertension constituted the groups most vulnerable to COVID-19 infection. Among respondents with confirmed COVID-19 cases, men, individuals aged 61 years and older, individuals with hypertension, and those diagnosed with pneumonia and respiratory failure were at higher risk of death. The number of community-based healthcare interventions was significantly associated with lower COVID-19 infection and COVID-19 mortality. Greater distance to a COVID-19 referral hospital increased risk of COVID-19 mortality., Conclusions: COVID-19 infection and death were related not only to sociodemographic characteristics of individuals but also to the presence of community-based healthcare interventions and access to hospital care. Strategies in public health, including improving healthcare access, are required to reduce COVID-19 infections among the most susceptible groups in Indonesia., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form and declare: all authors had financial support from The Directorate General of Higher Education, Ministry of Education and Culture, Republic of Indonesia for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Advances in surgical management strategies have substantially reduced fatality from congenital heart defects (CHD). Decreased infant mortality might be expected, consequentially to result in greater morbidity in older children due to complications later in childhood and adolescence. This study aims to evaluate the use of cardiovascular medication (CVM) as an indicator of disease burden in children born with CHD in the first 10 years of life., Design: Population-based cohort study., Setting: Six population-based registries from the European Surveillance of Congenital Anomalies (EUROCAT) network participated. Data from live born children with major congenital anomalies (CA) born from 2000 to 2014 were linked to prescription databases. Four groups of children were analysed: CA, CHD, severe CHD (sCHD) and ventricular septal defect (VSD) without sCHD. Live born children without CA were included as reference group., Participants: We obtained data on 61 038 children born with a CA, including 19 678 with CHD, 3392 with sCHD, 12 728 children with VSD without sCHD, and 1 725 496 reference children., Results: Children born with sCHD were the most likely to receive a CVM prescription (42.9%, 95% CI, 26.3 to 58.5) in the first year of life compared with 13.3% (6.7 to 22.0) of children with any CHD, 5.9% (3.7 to 8.7) of children with any CA and 0.1% (0.0 to 0.1) of reference children. Medication was less likely to be prescribed after the first year of life for sCHD; 18.8% (14.8 to 23.1) for children 1-4 years and 15.8% (12.0 to 20.1) 5-9 years. Children with sCHD were most likely to receive a diuretic (36.4%, 18.6 to 54.5), an antihypertensive (6.9%, 3.7 to 11.3) or a beta-blocker (5.5%, 2.9 to9.2)., Conclusion: Almost half of all children with sCHD were prescribed CVM in their first year of life. For all four groups of children with anomalies, the proportion of children with a CVM prescription decreased with age., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: To enhance health and prevent secondary consequences for patients with cardiovascular disease (CVD), maintenance of an active lifestyle following participation in cardiac rehabilitation (CR) is important. However, levels of physical activity often decrease after completion of a structured CR programme. Models that support long-term behaviour change with a sustained level of physical activity are imperative. The aim of this study is to evaluate the feasibility of a mobile health intervention based on the Health Action Process Approach theoretical model of behaviour change in patients with CVD for 3 months after completion of a CR programme., Methods and Analysis: In a feasibility trial design, we will recruit 40 participants from CR programmes at Slagelse Hospital, the City of Slagelse (municipality), or Holbæk Hospital. After completing the standard structured CR programme, each participant will create an action plan for physical activity together with a physiotherapist. Following that, participants are sent 2 weekly text messages for 3 months. The first text message prompts physical activity, and the second will check if the action plan has been followed. If requested by participants, a coordinator will call and guide the physical activities behaviour. The feasibility of this maintenance intervention is evaluated based on predefined progression criteria. Physical activity is measured with accelerometers at baseline and at 3 months follow-up., Ethics and Dissemination: Study approval was waived (EMN-2021-00020) by the Research Ethics Committee of Region Zealand, Denmark. Study results will be made public and findings disseminated to patients, health professionals, decision-makers, researchers and the public., Trial Registration Number: NCT05011994., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: This study aimed to investigate the association between kyphotic posture and future loss of independence (LOI) and mortality in community-dwelling older adults., Design: Prospective cohort study., Setting: Two Japanese municipalities., Participants: We enrolled 2193 independent community-dwelling older adults aged≥65 years at the time of their baseline health check-up in 2008. Kyphotic posture was evaluated using the wall-occiput test (WOT) and classified into three categories: non-kyphotic, mild (>0 and ≤4 cm) and severe (>4 cm)., Primary and Secondary Outcome Measures: The primary outcome was mortality and the secondary outcomes were LOI (new long-term care insurance certification levels 1-5) and a composite of LOI and mortality. A Cox proportional hazards model was used to estimate the adjusted HRs (aHRs)., Results: Of the 2193 subjects enrolled, 1621 were included in the primary analysis. Among these, 272 (17%) and 202 (12%) were diagnosed with mild and severe kyphotic postures, respectively. The median follow-up time was 5.8 years. Compared with the non-kyphotic group, the aHRs for mortality were 1.17 (95% CI 0.70 to 1.96) and 1.99 (95% CI 1.20 to 3.30) in the mild and severe kyphotic posture groups, respectively. In the secondary analysis, a consistent association was observed for LOI (mild: aHR 1.70, 95% CI 1.13 to 2.55; severe: aHR 2.08, 95% CI 1.39 to 3.10) and the LOI-mortality composite (mild: aHR 1.27, 95% CI 0.90 to 1.79; severe: aHR 1.83, 95% CI 1.31 to 2.56)., Conclusion: Kyphotic posture was associated with LOI and mortality in community-dwelling older adults. Identifying the population with kyphotic posture using the WOT might help improve community health., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The Intermountain Risk Score (IMRS), composed using published sex-specific weightings of parameters in the complete blood count (CBC) and basic metabolic profile (BMP), is a validated predictor of mortality. We hypothesised that IMRS calculated from prepandemic CBC and BMP predicts COVID-19 outcomes and that IMRS using laboratory results tested at COVID-19 diagnosis is also predictive., Design: Prospective observational cohort study., Setting: Primary, secondary, urgent and emergent care, and drive-through testing locations across Utah and in sections of adjacent US states. Viral RNA testing for SARS-CoV-2 was conducted from 3 March to 2 November 2020., Participants: Patients aged ≥18 years were evaluated if they had CBC and BMP measured in 2019 and tested positive for COVID-19 in 2020., Primary and Secondary Outcome Measures: The primary outcome was a composite of hospitalisation or mortality, with secondary outcomes being hospitalisation and mortality separately., Results: Among 3883 patients, 8.2% were hospitalised and 1.6% died. Subjects with low, mild, moderate and high-risk IMRS had the composite endpoint in 3.5% (52/1502), 8.6% (108/1256), 15.5% (152/979) and 28.1% (41/146) of patients, respectively. Compared with low-risk, subjects in mild-risk, moderate-risk and high-risk groups had HR=2.33 (95% CI 1.67 to 3.24), HR=4.01 (95% CI 2.93 to 5.50) and HR=8.34 (95% CI 5.54 to 12.57), respectively. Subjects aged <60 years had HR=3.06 (95% CI 2.01 to 4.65) and HR=7.38 (95% CI 3.14 to 17.34) for moderate and high risks versus low risk, respectively; those ≥60 years had HR=1.95 (95% CI 0.99 to 3.86) and HR=3.40 (95% CI 1.63 to 7.07). In multivariable analyses, IMRS was independently predictive and was shown to capture substantial risk variation of comorbidities., Conclusions: IMRS, a simple risk score using very basic laboratory results, predicted COVID-19 hospitalisation and mortality. This included important abilities to identify risk in younger adults with few diagnosed comorbidities and to predict risk prior to SARS-CoV-2 infection., Competing Interests: Competing interests: BDH, HTM, BSR and JLA are inventors of clinical decision tools that are licensed to CareCentra and Alluceo. BDH is the principal investigator (PI) of grants related to clinical decision tools that were funded by Intermountain Healthcare’s Foundry innovation programme, the Intermountain Research and Medical Foundation, CareCentra, GlaxoSmithKline and AstraZeneca. BDH is a member of the scientific advisory board of Labme.ai. KUK is PI and BDH is a coinvestigator of a grant funded by the Patient-Centered Outcomes Research Institute. IDP was supported by a grant from the National Institute of General Medical Sciences (K23GM129661). Outside the current work, IDP has received grant support from the National Institutes of Health, Centers for Disease Control and Prevention, Janssen Pharmaceuticals and Immunexpress Inc, and funding to his institution from Regeneron Pharmaceuticals. The authors have no other potential conflicts of interest to report., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To validate the Charlson Comorbidity Index (CCI) for the Colombian population using administrative databases from the health insurance system., Design: Retrospective cohort study., Setting: Database reports of events related to services that insurers provided (Health Promoter Enterprises, EPS in Spanish) in the Colombian health system, which covered 22.19 million residents in 2016., Participants: The study cohort comprised 3 849 849 patients aged 18 years and up admitted to the Colombian hospitals between 1 January and 31 December 2016., Primary Outcome: The study aimed to gauge the CCI's predictive value for mortality by comparing the calibration and discrimination of three different versions of the index, with mortality information obtained from death certificates, including date of death and diagnoses associated with cause of death. Follow-up was conducted for at least 1 year., Results: Altogether, 46 429 patients died within 1 year (1.21%). Discriminatory power in predicting 1-year mortality was calculated for three versions of the ICC. In the original CCI model, the area under the Receiver operating characteristic (ROC) curve was 0.906 (95% CI (0.906 to 0.907), p<0.001). In the version for Colombia, it was 0.908 (95% CI (0.908 to 0.909), p<0.001) and for the new model it was 0.909 (95% CI (0.908 to 0.910), p<0.001)., Conclusions: Adapting the CCI based on the 14 predictive variables of the new model resulted in an adequate predictive value for 1-year mortality in patients who were hospitalised for all causes. These findings support the use of the modified CCI in the Colombian population., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To assess multiple preventive care measures and to examine their associations with having a usual source of primary care and primary care performance during the COVID-19 pandemic in Japan., Design: Nationwide cross-sectional study., Setting: Japanese general adult population., Participants: 1757 adult residents., Primary Outcome Measures: Fourteen preventive care measures aggregated the overall screening, immunisation and counselling composites., Results: Depression screening, zoster vaccination and tetanus vaccination had low implementation rates even among participants with a usual source of primary care. After adjustment for possible confounders, having a usual source of primary care was positively associated with all preventive care composites. Primary care performance assessed by the Japanese version of Primary Care Assessment Tool Short Form was also dose dependently associated with an increase in all composites. Results of the sensitivity analyses using a different calculation of preventive care composite were similar to those of the primary analyses., Conclusions: Receipt of primary care, particularly high-quality primary care, contributed to increased preventive care utilisation even during the COVID-19 pandemic. However, the rate of mental health screening in primary care was at a very low level. Therefore, addressing mental health issues should be a major challenge for primary care providers during and after the pandemic., Competing Interests: Competing interests: TA and MM received lecture fees and lecture travel fees from the Centre for Family Medicine Development of Japanese Health and Welfare Co-operative Federation and are advisers of the Centre for Family Medicine Development practice-based research network. MM’s son-in-law worked at IQVIA Services Japan K.K., which is a contract research organisation and a contract sales organisation, and currently works at Syneos Health Clinical K.K., which is a contract research organisation and a contract sales organisation., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Chad reports the second highest maternal mortality worldwide. We conducted a survey in Sila region in southeast Chad to estimate the use of maternal health services (MHS) and to identify barriers to access MHS., Design: Retrospective cross-sectional, population-based survey using two-stage cluster sampling methodology. The survey consisted of two strata, Koukou Angarana and Goz Beida district in Sila region. We conducted systematic random sampling proportional to population size to select settlements in each strata in the first sampling stage; and in the second stage we selected households in the settlements using random walk procedure. We calculated survey-design-weighted proportions with 95% CIs. We performed univariate analysis and multivariable logistic regression to identify impact factors associated with the use of MHS., Setting: We interviewed women in selected households in Sila region in 2019., Participants: Women at reproductive age, who have given birth in the previous 2 years and are living in Koukou Angarana and Goz Beida district., Primary Outcomes: Use of and access barriers to MHS including antenatal care (ANC), delivery care in a health facility (DC), postnatal care (PNC) and contraceptive methods., Results: In total, 624 women participated. Median age was 28 years, 95.4% were illiterate and 95.7% married. Use of ANC, DC and PNC was reported by 57.6% (95% CI: 49.3% to 65.5%), 22.5% (95% CI: 15.7% to 31.1%) and 32.9% (95% CI: 25.8% to 40.9%), respectively. Use of MHS was lower in rural compared with urban settings. Having attended ANC increased the odds of using DC by 4.3 (1.5-12.2) and using PNC by 6.4 (3.7-11.1). Factors related to transport and to culture and belief were the most frequently stated access barriers to MHS., Conclusion: In Sila region, use of MHS is low and does not meet WHO-defined standards regarding maternal health. Among all services, use of ANC was better than for other MHS. ANC usage is positively associated with the use of further life-saving MHS including DC and could be used as an entry point to the community. To increase use of MHS, interventions should include infrastructural improvements as well as community-based approaches to overcome access barriers related to culture and belief., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To compare the efficacy and safety of alternative glucocorticoids (GCs) regimens as induction therapy for patients with antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis., Design: Systematic review of randomised controlled trials (RCTs)., Data Sources: Medline, Embase, Clinicaltrials.gov and Cochrane Central Register of Controlled Trials up to 10 April 2020., Study Selection and Review Methods: RCTs comparing two (or more) different dose regimens of GC in ANCA-associated vasculitis during induction of remission, regardless of other therapies. Pairs of reviewers independently screened records, extracted data and assessed risk of bias. Two reviewers rated certainty of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach., Results: Of 3912 records identified, the full texts of two records met the eligibility criteria. Due to the heterogeneity of population and dose regimen of GCs between the two trials, we descriptively presented the two trials and did not combine the results using meta-analysis. Compared with the standard-dose regimen, the reduced-dose regimen of GC may reduce death risk difference (RD): from -1.7% to -2.1%, low certainty), while not increasing end-stage kidney disease (ESKD) (RD: from -1.5% to 0.4%, moderate certainty). The reduced-dose regimen probably has an important reduction in serious infections at 1 year (RD: from -12.8% to -5.9%, moderate certainty). Reduced-dose regimen of GCs probably has trivial or no effect in disease remission, relapse or health-related quality of life (moderate to high certainty)., Conclusions: The reduced-dose regimen of GC may reduce death at the follow-up of 6 months to longer than 1 year and serious infections while not increasing ESKD., Prospero Registration Number: CRD42020179087., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The high cost of many healthy foods poses a challenge to maintaining optimal blood glucose levels for adults with type 2 diabetes mellitus who are experiencing food insecurity, leading to diabetes complications and excess acute care usage and costs. Healthy food prescription programmes may reduce food insecurity and support patients to improve their diet quality, prevent diabetes complications and avoid acute care use. We will use a type 2 hybrid-effectiveness design to examine the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) of a healthy food prescription incentive programme for adults experiencing food insecurity and persistent hyperglycaemia. A randomised controlled trial (RCT) will investigate programme effectiveness via impact on glycosylated haemoglobin (primary outcome), food insecurity, diet quality and other clinical and patient-reported outcomes. A modelling study will estimate longer-term programme effectiveness in reducing diabetes-related complications, resource use and costs. An implementation study will examine all RE-AIM domains to understand determinants of effective implementation and reasons behind programme successes and failures., Methods and Analysis: 594 adults who are experiencing food insecurity and persistent hyperglycaemia will be randomised to a healthy food prescription incentive (n=297) or a healthy food prescription comparison group (n=297). Both groups will receive a healthy food prescription. The incentive group will additionally receive a weekly incentive (CDN$10.50/household member) to purchase healthy foods in supermarkets for 6 months. Outcomes will be assessed at baseline and follow-up (6 months) in the RCT and analysed using mixed-effects regression. Longer-term outcomes will be modelled using the UK Prospective Diabetes Study outcomes simulation model-2. Implementation processes and outcomes will be continuously measured via quantitative and qualitative data., Ethics and Dissemination: Ethical approval was obtained from the University of Calgary and the University of Alberta. Findings will be disseminated through reports, lay summaries, policy briefs, academic publications and conference presentations., Trial Registration Number: NCT04725630., Protocol Version: Version 1.1; February 2022., Competing Interests: Competing interests: DLO and DJTC have received funding from a Petro-Canada Young Innovator Award in Community Health. The remaining authors declare that they have no competing interests., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: The global burden of kidney failure is increasing, but the treatment of kidney failure varies widely between patients, between dialysis facilities and over time. The Alliance for Quality Assessment in Healthcare-Dialysis (AQuAH-D) aims to conduct efficient and timely cohort studies on associations between those variations and clinical and patient-reported outcomes., Participants: Included are outpatients aged 20 years old or older who are undergoing haemodialysis and have consented to participate. A total of 2895 patients were enrolled from 25 facilities in Japan between August 2018 and July 2020 and are to be followed until 31 December 2026. Chart review and annual questionnaires are used to collect data on patient characteristics and on outcomes including quality of life. Data on medications, haemodialysis prescriptions and blood tests are obtained from existing electronic records. Data are collected retrospectively from 1 January 2017 to patient enrolment, and prospectively from patient enrolment until the end of December 2026., Findings to Date: To date, the mean age is 68.3 (SD 12.2) years and 35.2% are female. The most common cause of kidney failure is diabetic nephropathy (37.4%). In January 2020, the facilities' median weekly doses of erythropoietin stimulating agent (ESA) and of intravenous vitamin D ranged from 1846 to 9692 IU (epoetin alfa equivalent) and 0.78 to 2.25 µg (calcitriol equivalent), respectively. The facilities' percentages of patients to whom calcimimetics are prescribed varied from 19% to 79%. During the retrospective period (averaging 1.85 years per participant), the incidence rates of any hospitalisation and of hospitalisation due to cardiovascular disease were 67.2 and 12.0 per 100 person-years, respectively., Future Plans: AQuAH-D data will be updated every 6 months and will be available for studies addressing a wide range of research questions, using the advantages of granular data and quality-of-life measurement of ageing patients on haemodialysis., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Evidence supporting the effects of primary care structures on the quality of care for patients with complex multimorbidity, which is one of the most important challenges facing primary care, is scarce internationally. This study aimed to examine the associations of the types of primary care facilities with polypharmacy and patient-reported indicators in patients with complex multimorbidity, with a focus on differences between community clinics and hospitals., Design: Multicentre cross-sectional study., Setting: A total of 25 primary care facilities (19 community clinics and 6 small- and medium-sized hospitals)., Participants: Adult outpatients with complex multimorbidity, which was defined as the co-occurrence of three or more chronic conditions affecting three or more different body systems within one person., Primary Outcome Measure: Polypharmacy, the Patient-Reported Experience Measure using the Japanese version of Primary Care Assessment Tool Short Form (JPCAT-SF) and the Patient-Reported Outcome Measure using self-rated health status (SRH)., Results: Data were analysed for 492 patients with complex multimorbidity. After adjustment for possible confounders and clustering within facilities, clinic-based primary care practices were significantly associated with a lower prevalence of polypharmacy, higher JPCAT-SF scores in coordination and community orientation, and a lower prevalence of poor or fair SRH compared with hospital-based primary care practices. In contrast, the JPCAT-SF score in first contact was significantly lower in clinic-based practices. The associations between the types of primary care facilities and JPCAT-SF scores in longitudinality and comprehensiveness were not statistically significant., Conclusions: Clinic-based primary care practices were associated with a lower prevalence of polypharmacy, better patient experience of coordination and community orientation, and better SRH in patients with complex multimorbidity compared with hospital-based primary care practices. In the primary care setting, small and tight teams may improve the quality of care for patients with complex multimorbidity., Competing Interests: Competing interests: TA and MM received lecture fees and lecture travel fees from the Centre for Family Medicine Development of Japanese Health and Welfare Co-operative Federation. TA and MM are advisers of the Centre for Family Medicine Development practice-based research network. MM’s son-in-law worked at IQVIA Services Japan K.K. which is a contract research organisation and a contract sales organisation. MM’s son-in-law works at SYNEOS HEALTH CLINICAL K.K. which is a contract research organisation and a contract sales organisation., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To describe the epidemiology of sexually transmitted infections (STIs), identify and characterise socio-epidemiological clusters and determine factors associated with HIV coinfection., Design: Retrospective population-based cohort., Setting: Catalonia, Spain., Participants: 42 283 confirmed syphilis, gonorrhoea, chlamydia and lymphogranuloma venereum cases, among 34 600 individuals, reported to the Catalan HIV/STI Registry in 2017-2019., Primary and Secondary Outcomes: Descriptive analysis of confirmed STI cases and incidence rates. Factors associated with HIV coinfection were determined using logistic regression. We identified and characterized socio-epidemiological STI clusters by Basic Health Area (BHA) using K-means clustering., Results: The incidence rate of STIs increased by 91.3% from 128.2 to 248.9 cases per 100 000 population between 2017 and 2019 (p<0.001), primarily driven by increase among women (132%) and individuals below 30 years old (125%). During 2017-2019, 50.1% of STIs were chlamydia and 31.6% gonorrhoea. Reinfections accounted for 10.8% of all cases and 6% of cases affected HIV-positive individuals. Factors associated with the greatest likelihood of HIV coinfection were male sex (adjusted OR (aOR) 23.69; 95% CI 16.67 to 35.13), age 30-39 years (versus <20 years, aOR 18.58; 95% CI 8.56 to 52.13), having 5-7 STI episodes (vs 1 episode, aOR 5.96; 95% CI 4.26 to 8.24) and living in urban areas (aOR 1.32; 95% CI 1.04 to 1.69). Living in the most deprived BHAs (aOR 0.60; 95% CI 0.50 to 0.72) was associated with the least likelihood of HIV coinfection. K-means clustering identified three distinct clusters, showing that young women in rural and more deprived areas were more affected by chlamydia, while men who have sex with men in urban and less deprived areas showed higher rates of STI incidence, multiple STI episodes and HIV coinfection., Conclusions: We recommend socio-epidemiological identification and characterisation of STI clusters and factors associated with HIV coinfection to identify at-risk populations at a small health area level to design effective interventions., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: In Africa, the number of patients with hypertension is expected to reach 216.8 million by 2030. Large-scale data on antihypertensive medications used in Sub-Saharan Africa (SSA) are scarce.Here, we describe antihypertensive drug strategies and identify treatment factors associated with blood pressure (BP) control in 12 Sub-Saharan countries., Setting: Outpatient consultations for hypertension in urban tertiary cardiology centres of 29 hospitals from 17 cities across 12 SSA countries between January 2014 and November 2015., Participants: Patients ≥18 years of age with hypertension were enrolled at any visit during outpatient consultations in the cardiology departments MAIN OUTCOME MEASURE: We collected BP levels, demographic characteristics and antihypertensive treatment use (including traditional medicine) of patients with hypertension attending outpatient visits. BP control was defined as seated office BP <140/90 mm Hg. We used logistic regression with a random effect on countries to assess factors of BP control., Results: Overall, 2198 hypertensive patients were included and a total of 96.6% (n=2123) were on antihypertensive medications. Among treated patients, 653 (30.8%) patients received a monotherapy by calcium channel blocker (n=324, 49.6%), renin-angiotensin system blocker (RAS) (n=126, 19.3%) or diuretic (n=122, 18.7%). Two-drug strategies were prescribed in 927 (43.6%) patients including mainly diuretics and RAS (n=327, 42% of two-drug strategies). Prescriptions of three-drugs or more were used in 543 (25.6%) patients. Overall, among treated patients, 1630 (76.7%) had uncontrolled BP, of whom 462 (28.3%) had BP levels ≥180/110 mm Hg, mainly in those on monotherapy. After adjustment for sociodemographic factors, the use of traditional medicine was the only factor significantly associated with uncontrolled BP (OR 1.72 (1.19 to 2.49) p<0.01)., Conclusion: Our study provided large-scale data on antihypertensive prescriptions in the African continent. Among patients declared adherent to drugs, poor BP control was significantly associated with the use of traditional medicine., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: From a reproductive justice framework, we aimed to investigate how a possible association between hormonal contraceptive (HC) and antidepressants use (as a proxy for depression) is distributed across intersectional strata in the population. We aimed to visualise how intersecting power dynamics may operate in combination with HC use to increase or decrease subsequent use of antidepressants. Our main hypothesis was that the previously observed association between HC and antidepressants use would vary between strata, being more pronounced in more oppressed intersectional contexts. For this purpose, we applied an intersectional multilevel analysis of individual heterogeneity and discriminatory accuracy approach., Design: Observational prospective cohort study using record linkage of national Swedish registers., Setting: The population of Sweden., Participants: All 915 954 women aged 12-30 residing in Sweden 2010, without a recent pregnancy and alive during the individual 1-year follow-up., Primary Outcome Measure: Use of any antidepressant, meaning being dispensed at least one antidepressant (ATC: N06A) during follow-up., Results: Previously mentally healthy HC users had an OR of 1.79 for use of antidepressants compared with non-users, whereas this number was 1.28 for women with previous mental health issues. The highest antidepressant use were uniformly found in strata with previous mental health issues, with highest usage in women aged 24-30 with no immigrant background, low income and HC use (51.4%). The largest difference in antidepressant use between HC users and non-users was found in teenagers, and in adult women of immigrant background with low income. Of the total individual variance in the latent propensity of using antidepressant 9.01% (healthy) and 8.16% (with previous mental health issues) was found at the intersectional stratum level., Conclusions: Our study suggests teenagers and women with immigrant background and low income could be more sensitive to mood effects of HC, a heterogeneity important to consider moving forward., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Objectives: To examine the association between facility-level adherence to phosphorus management guidelines and mortality among patients with haemodialysis, and to explore the facility-related factors associated with facility-level guideline adherence., Design: Prospective cohort study., Setting: The Dialysis Outcomes and Practice Pattern Study, which included 57 representative dialysis facilities in Japan between 2012 and 2015., Participants: A total of 2054 adult patients who received maintenance haemodialysis were included. We defined exposure according to the following four categories, depending on whether facility-level target ranges of serum phosphorus concentration adhered to the Japanese clinical practice guidelines: adherence group (lower limit ≥3.5 mg/dL and upper limit ≤6.0 mg/dL), low-target group (lower limit <3.5 and upper limit ≤6.0), wide-target group (lower limit <3.5 and upper limit >6.0) and high-target group (lower limit ≥3.5 and upper limit >6.0)., Primary Outcome Measure: The primary outcome was the patient all-cause mortality rate., Results: The mortality rate among the patients was 7.3 per 100 person-years; 27 facilities (47%) set targets according to the guidelines. HRs for mortality with reference to the adherence group were 1.04 (95% CI 0.76 to 1.43) in the low-target group, 1.11 (95% CI 0.68 to 1.81) in the wide-target group and 1.95 (95% CI 1.12 to 3.38) in the high-target group. Involvement of dieticians in dialysis treatment was associated with facility-level guideline adherence (OR 4.51; 95% CI 1.15 to 17.7)., Conclusions: A higher facility-level target range for phosphorus was associated with increased patient mortality. Among facilities that set the target according to the guidelines, dieticians tended to be involved in dialysis care. These findings suggest the importance of reviewing facilities' treatment policies in relation to updated guidelines and the need to work with relevant professionals., Competing Interests: Competing interests: SF has acted as a scientific advisor to Kyowa Kirin. TI, SS, TH, YM and YY have no relevant financial interests., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The COVID-19 pandemic has forced many people to stay at home and to maintain social distancing. This study aimed to assess the association of reduced physical activity during the COVID-19 pandemic with new onset of neck pain (katakori) among a rural Japanese population living in areas damaged by the Great East Japan Earthquake (GEJE)., Design, Setting and Participants: This prospective cohort study has been conducted continuously since 2011 after the GEJE. This study used longitudinal data from 1608 adults who responded to the self-reported questionnaire before and during the COVID-19 pandemic. Changes in physical activity due to the COVID-19 pandemic were categorised into four groups: 'no change', 'decreased by 20%-30%', 'decreased by half' and 'almost never go out'. Multiple logistic regression analysis was used to estimate the OR and 95% CI of the association between COVID-19 pandemic-related physical inactivity and new-onset neck pain., Results: In total, 'no change', 'decreased by 20%-30%', 'decreased by half', and 'almost never go out' were reported by 9.2%, 27.7%, 31.2% and 21.9% of respondents, respectively. Among them, 9.8% reported new-onset neck pain. A significantly higher rate of new-onset neck pain was observed in participants who reported 'decreased by half' (adjusted OR 1.85, 95% CI 1.04 to 3.30) and who 'almost never go out' (adjusted OR 2.13, 95% CI 1.16 to 3.91), compared with those who reported 'no change.', Conclusions: Decreased physical activity has increased due to the COVID-19 pandemic and was significantly associated with new-onset neck pain among GEJE survivors., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: The study 'Health among women after pelvic radiotherapy' was conducted in response to the need for more advanced and longitudinal data concerning long-term radiotherapy-induced late effects and chronic states among female cancer survivors. The objective of this paper is to detail the cohort profile and the study procedure in order to provide a sound basis for future analyses of the study cohort., Participants: Since 2011, and still currently ongoing, participants have been recruited from a population-based study cohort including all female patients with cancer, over 18 years of age, treated with pelvic radiotherapy with curative intent at Sahlgrenska University Hospital in Gothenburg, in the western region of Sweden, which covers 1.7 million of the Swedish population. The dataset presented here consists of baseline data provided by 605 female cancer survivors and 3-month follow-up data from 260 individuals with gynaecological, rectal or anal cancer, collected over a 6-year period., Findings to Date: Data have been collected from 2011 onwards. To date, three studies have been published using the dataset reporting long-term radiation-induced intestinal syndromes and late adverse effects affecting sexuality, the urinary tract, the lymphatic system and physical activity. These projects include the evaluation of interventions developed by and provided in a nurse-led clinic., Future Plans: This large prospective cohort offers the possibility to study health outcomes in female pelvic cancer survivors undergoing a rehabilitation intervention in a nurse-led clinic, and to study associations between demographics, clinical aspects and long-term late effects. Analysis focusing on the effect of the interventions on sexual health aspects, preinterventions and postinterventions, is currently ongoing. The cohort will be expanded to comprise the entire data collection from 2011 to 2020, including baseline data and data from 3-month and 1-year follow-ups after interventions. The data will be used to study conditions and treatment-induced late effects preintervention and postintervention., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To develop and validate a rule-out prediction model for the risk of hospitalisation among patients with SARS-CoV-2 infection in the ambulatory setting to derive a simple score to determine outpatient follow-up., Design: Prospective cohort study., Setting: Swiss university hospital., Participants: 1459 individuals with a positive result for SARS-CoV-2 infection between 2 March and 23 April 2020., Methods: We applied the rule of 10 events per variable to construct our multivariable model and included a maximum of eight covariates. We assessed the model performance in terms of discrimination and calibration and performed internal validation to estimate the statistical optimism of the final model. The final prediction model included age, fever, dyspnoea, hypertension and chronic respiratory disease. To develop the OUTCoV score, we assigned points for each predictor that were proportional to the coefficients of the regression equation. Sensitivity, specificity, positive and negative likelihood ratios were estimated, including positive and negative predictive values in different thresholds., Main Outcome Measure: The primary outcome was COVID-19-related hospitalisation., Results: The OUTCoV score ranged from 0 to 7.5 points. The two threshold parameters with optimal rule-out and rule-in characteristics for the risk of hospitalisation were 3 and 5.5, respectively. Outpatients with a score <3 (997/1459; 68.3%) had no follow-up as at low risk of hospitalisation (1.8%; 95% CI 1.1 to 2.8). For a score ≥5.5 (20/1459; 1.4%), the hospitalisation risk was higher (30%; 95% CI 11.9 to 54.3)., Conclusions: The OUTCoV score allows to rule out two-thirds of outpatients with SARS-CoV-2 infection presenting a low hospitalisation risk and to identify those at high risk that require careful follow-up to assess the need for hospitalisation. The model provides a simple decision-making tool for an effective allocation of resources to maintain quality care for outpatient populations., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Longitudinal studies, which consider multimorbidity patterns, are useful for better clarifying the effect of multimorbidity on health-related quality of life (HRQoL) and for identifying the target population with poorer clinical outcomes among patients with multimorbidity. This study aimed to examine the effects of different multimorbidity patterns on the decline in HRQoL., Design: Nationwide prospective cohort study., Setting: Japanese adult residents., Participants: Residents aged ≥50 years selected by the quota sampling method., Primary Outcome Measure: Clinically relevant decline in HRQoL was defined as a 0.50 SD (5-point) decrease in the 36-Item Short Form Health Survey (SF-36) component summary scores for 1 year., Results: In total, 1211 participants completed the follow-up survey. Among the multimorbidity patterns identified using confirmatory factor analysis, multivariable logistic regression analyses revealed that high cardiovascular/renal/metabolic and malignant/digestive/urologic pattern scores were significantly associated with the clinically relevant decline in SF-36 physical component summary score (adjusted OR (aOR)=1.25, 95% CI: 1.08 to 1.44 and aOR=1.28, 95% CI: 1.04 to 1.58, respectively). High cardiovascular/renal/metabolic pattern score was also significantly associated with the clinically relevant decline in SF-36 role/social component summary score (aOR=1.23, 95% CI: 1.06 to 1.42)., Conclusions: Our study revealed that multimorbidity patterns have different effects on the clinically relevant decline in HRQoL for 1 year. These findings can be useful in identifying populations at high risk and with poor clinical outcomes among patients with chronic diseases and multimorbidity for efficient resource allocation., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)