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ObjectivesTo evaluate the real-world association between varenicline and neuropsychiatric adverse events (NPAEs) in general and chronic obstructive pulmonary disease (COPD) population with and without psychiatric disorders compared with nicotine replacement therapy (NRT) to strengthen the knowledge of varenicline safety.DesignA retrospective cohort study.SettingPrescription database IADB.nl, the Netherlands.ParticipantsNew users of varenicline or NRT among general (≥18 years) and COPD (≥40 years) population. Psychiatric subcohort was defined as people prescribed psychotropic medications (≥2) within 6 months before the index date.Outcome measuresThe incidence of NPAEs including depression, anxiety and insomnia, defined by new or naive prescriptions of related medications in IADB.nl within 24 weeks after the first treatment initiation of varenicline or NRT.ResultsFor the general population in non-psychiatric cohort, the incidence of total NPAEs in varenicline (4480) and NRT (1970) groups was 10.5% and 12.6%, respectively (adjusted OR (aOR) 0.85, 95% CI 0.72 to 1.00). For the general population in psychiatric cohort, the incidence of total NPAEs was much higher, 75.3% and 78.5% for varenicline (1427) and NRT (1200) groups, respectively (aOR 0.82, 95% CI 0.68 to 0.99). For the COPD population (1598), there were no differences in the incidence of NPAEs between comparison groups in both the psychiatric cohort (aOR 0.97, 95% CI 0.66 to 1.44) and non-psychiatric cohort (aOR 0.81, 95% CI 0.54 to 1.20). Results from subgroup or sensitivity analyses also did not reveal increased risks of NPAEs but showed decreased risk of some subgroup NPAEs associated with varenicline.ConclusionsIn contrast to the concerns of a possible increased risk of NPAEs among varenicline users, we found a relative decreased risk of total NPAEs in varenicline users of the general population in psychiatric or non-psychiatric cohorts compared with NRT and no difference for NPAEs between varenicline and NRT users in smaller population with COPD.

IntroductionSpin is defined as reporting practices that distort the interpretation of results and create misleading conclusions by suggesting more favourable results. Such unjustifiable and misleading misrepresentation may negatively influence the development of further studies, clinical practice and healthcare policies. Spin manifests in various patterns in different sections of publications (titles, abstracts and main texts). The primary aim of this study is to identify reported spin patterns and assess the prevalence of spin in general, and the prevalence of spin patterns reported in biomedical literature based on previously published systematic reviews and literature reviews on spin.Methods and analysisPubMed, EMBASE and SCOPUS will be searched to identify systematic or literature reviews on spin in biomedicine. To improve the comprehensiveness of the search, the snowballing method will be used to broaden the search. The data on spin-related outcomes and characteristics of the included studies will be extracted. The methodological quality of the included studies will be assessed with selective items of the A MeaSurement Tool to Assess systematic Reviews-2 checklist. A new classification scheme for spin patterns will be developed if the classifications of spin patterns identified in the included studies vary. The prevalence of spin and spin patterns will be pooled based on meta-analyses if the classification schemes for spin are comparable across included studies. Otherwise, the prevalence will be described qualitatively. The seriousness of spin patterns will be assessed based on a Delphi consensus study.Ethics and disseminationThis study has been approved by the Academic Centre for Dentistry Amsterdam Ethics Review Committee (2020250). The study will be submitted to a peer-reviewed scientific journal.RegistrationOpen Science Framework: osf.io/hzv6e

ObjectiveTo explore how parents judge disease severity of their febrile child and to identify symptoms they associate with serious illness, minor illness or health.DesignSemistructured interviews were conducted. Interviews were audio taped, transcribed verbatim and analysed thematically.ParticipantsParents of children aged 0–5 years with a febrile illness.SettingParticipants were recruited at the paediatric ward and the emergency department.ResultsTwenty-six interviews were conducted, in which 37 parents participated. Parents described disease severity of their child mainly in terms of changes in their child’s normal characteristics (behaviour and physical features). They found it harder to describe specific disease symptoms such as dyspnoea or dehydration. Their child being active, eating and drinking well, and smiling were perceived as reassuring, whereas high fever, moving very little and uncertainty about the type of infections were mentioned as alarming symptoms. Previous experience with febrile illnesses in their children was of great influence on the number and accuracy of symptoms they reported.ConclusionParents used the normal behaviour and physical features of their child as a reference frame for judging disease severity. With a larger deviation from the child’s normal characteristics, parents considered the illness more serious. They were less able to describe specific symptoms of disease such as dyspnoea or dehydration. This knowledge is important for clinicians in their communication with parents of children with febrile illness.

ObjectiveTo assess trends in systolic blood pressure (SBP) thresholds at initiation of antihypertensive treatment in patients with type 2 diabetes and the impact of age and frailty on these trends.Study design and settingA repeated cross-sectional cohort study (2007–2014) using the Groningen Initiative to Analyse Type 2 diabetes Treatment database was conducted. The influence of calendar year, age or frailty and the interaction between year and age or frailty on SBP thresholds were assessed using multilevel regression analyses adjusted for potential confounders.ResultsWe included 4819 patients. The mean SBP at treatment initiation was 157 mm Hg in 2007, rising to 158 mm Hg in 2009 and decreasing to 151 mm Hg in 2014. This quadratic trend was significant (pConclusionAfter an initial rise, the observed SBP thresholds decreased over time and were not influenced by age or frailty. This is in contrast with changed guideline recommendations towards more personalised treatment during the study period and illustrates that changing prescribing practice may take considerable time. Patient-specific algorithms and tools focusing on when and when not to initiate treatment could be helpful to support personalised diabetes care.

IntroductionStrict imaging surveillance protocols to detect complications following endovascular aneurysm repair (EVAR) are common practice. However, controversy exists as to whether all EVAR patients need intense surveillance. The 2019 European Society for Vascular Surgery guidelines for management of abdominal aortic aneurysm (AAA) suggest that patients may be considered for limited follow-up with imaging if classified as ‘low risk’ for complications based on their initial postoperative imaging. The current study aims to investigate the intervention-free survival and overall survival stratified for patients with and without yearly imaging surveillance.Methods and analysisThe Observing a Decade of Yearly Standardised Surveillance in EVAR patients with Ultrasound or CT Scan study comprises a national multicentre retrospective cohort study in 17 medical centres. Consecutive patients with an asymptomatic or symptomatic infrarenal AAA who underwent EVAR between January 2007 and January 2012 will be included in this study with follow-up until December 2018. Clinical variables and all follow-up information will be retrieved in extensive data collection from the patient’s medical records. In addition, an e-survey was sent to vascular surgeons at the 17 participating centres to gauge their opinions regarding the possibility of safely reducing the frequency of imaging surveillance. Primary endpoints are intervention after EVAR and aneurysm-related mortality. The initial estimated sample size is 1997 patients.Ethics and disseminationThe study has been approved by the Medical Ethics Review Committee of the Amsterdam UMC, location Academic Medical Centre, Amsterdam, the Netherlands. Study findings will be disseminated via presentations at conferences and publications in peer-reviewed journal.Trial registration numberThe Netherlands Trial Registry, NL6953 (old: NTR28773).

ObjectivesTo assess the association between blood circulating Vitamin D levels and colorectal cancer risk in the Asian population.DesignThis is a systematic review and dose-response meta-analysis of observational studies that investigated the relationship between blood circulating Vitamin D levels and colorectal cancer risk in the Asian population.Data SourcesRelevant studies were identified through a literature search in MEDLINE, EMBASE, and Web of Science from January 1980 to 31 January 2019. Eligibility criteria: original studies published in peer-reviewed journals investigating the association between blood circulating Vitamin D levels and the risk of colorectal cancer and/or adenoma in Asian countries.Data extraction and synthesisTwo authors independently extracted data and assessed the quality of included studies. Study-specific ORs were pooled using a random-effects model. A dose-response meta-analysis was performed with generalized least squares regression. We applied the Newcastle-Ottawa Scale quality assessment to evaluate the quality of the selected studies.ResultsThe eight included studies encompassed a total of 2,916 cases and 6,678 controls. The pooled ORs of colorectal cancer for the highest versus lowest categories of blood circulating Vitamin D levels was 0.75 [95% CI, 0.58-0.97] up to 36.5 ng/mL in the Asian population. There was heterogeneity among the studies (I2=53.9%, Pheterogeneity=0.034). The dose-response meta-analysis indicated a significant linear relationship (Pnon-linearity=0.11). An increment of 16 ng/mL in blood circulating Vitamin D level corresponded to an OR of 0.79 [95% CI, 0.64-0.97].ConclusionsThe results of this meta□analysis indicate that blood circulating Vitamin D level is associated with decreased risk of colorectal cancer in Asian countries. The dose-response meta-analysis shows that the strength of this association among the Asian population is similar to that among the Western population. Our study suggests that the Asian population should improve nutritional status and maintain a higher level of blood circulating Vitamin D.Strengths and limitations of this studyOur study seeks to extend previous work by including a number of new studies and by distinguishing the Asian population explicitly.The number of included studies is not sufficient to provide a robust estimate, so the results should be interpreted in the context of the limitations of the available data.Heterogeneous definitions of blood circulating Vitamin D categories were used across studies. The variability in definitions could limit comparability between studies.Our study included seven case-control studies; the study design implies that the measurement of blood circulating Vitamin D is measured in individuals already diagnosed with colorectal cancer. Results from case-control studies need to be interpreted cautiously because of the potential for reverse causation.Time of blood sampling in relation to outcome ascertainment also varied among studies. Such cross-sectional measurements may not accurately reflect an individual’s Vitamin D status across time.

ObjectiveTo investigate the occurrence of live birth in women with Turner syndrome (TS) after ovarian tissue cryopreservation in childhood followed by auto transplantation in adulthood and to find reliable prognostic markers for estimating the ovarian reserve in girls with TS in the future.SettingAn observational cohort study with long-term follow-up in a tertiary fertility clinic in the Netherlands. Patients recruitment between January 2018 and December 2021.Participants100 females aged 2 through 18 years with classical Turner (ie, 45,X0) or Turner variants (ie, 45,X mosaicism or structural anomalies). Girls with Y chromosomal content, minor X deletions with marginal impact on fertility, active HIV, hepatitis B or hepatitis C infection, and/or an absolute contra indication for surgery, anaesthesia or future pregnancy will be excluded.InterventionsOvarian cortical tissue will be harvested by performing a unilateral oophorectomy via laparoscopic approach. Ovarian cortex fragments will be prepared and cryopreserved. One fragment per patient will be used to determine follicular density by conventional histology, and to perform fluorescence in situ hybridisation analysis of ovarian cells. Routine chromosome analysis will be performed on both lymphocytes and buccal cells. A blood sample will be taken for hormonal analysis and all subjects will undergo a transabdominal ultrasound to determine the uterine and ovarian size. Patient characteristics, pregnancy rates and pregnancy outcomes will be collected from the patient’s medical record.Ethics and disseminationThe study protocol has been approved by the Central Committee on Research Involving Human Subjects in November 2017 (CCMO NL57738.000.16).Trial registration numberNCT03381300.

Introduction Mild cognitive impairment is one of the consequences of ageing, causing functional disability, a poor quality of life and an increased socioeconomic expenditure. Evidence shows that patients go through a long preclinical stage in which cognitive deficits appear subtly until they reach the threshold of dementia. Non-pharmacological interventions have been gaining ground as prevention of modifiable factors of cognitive decline such as obesity, diabetes, physical inactivity or social isolation. Along these lines, Information and Communication Technologies (ICTs) can be a tool for cognitive stimulation, cognitive training and cognitive rehabilitation. The main objective of the systematic review will be to review and analyse the use of ICTs for the improvement of cognitive functions in healthy older adult population aged 50 and over, for the prevention of cognitive impairment Methods A systematic review will be conducted including randomised clinical trials in adults without diseases or accidents associated with cognitive impairment, and whom have used ICTs for the improvement of cognitive functions between 2010 and 2020 in English or Spanish. The articles that report data on cognitive function by domain, for example, memory or executive functions, or by test will be included. The databases Medline (PubMed), CinahlPlus, Scopus, ISI WoS, CENTRAL and IEEE Xplore will be searched. Studies that meet the inclusion criteria will be analysed according to the Cochrane RoB2 tool for risk of bias assessment. Ethics and dissemination Ethical approval is not necessary as this is a systematic review. The results will be published in scientific journals, as well as in specialised congresses on the subject of study This paper is a result of the NEXTPERCEPTION project (www.nextperception.eu), which is jointly funded by the European Commission and national funding agencies under the ECSEL joint undertaking. Agencia Estatal de Investigación (AEI). AEI/10.13039/501100011033. PCI2020-112270. Ministery of Science and Innovation (MICINN). CERCA Programme / Generalitat de Catalunya. IRBLleida - Fundació Dr. Pifarré. This paper was also funded by College of Nurses of Lleida, University of Lleida (Aid to promote research in deficit areas) and Predoctoral staff in Training Program University of Lleida, Jade Plus, and La Caixa Bank Foundation 2019

ObjectivesThe Abilitator is a patient-reported outcome measure (PROM) of work ability and functioning of those in a weak labour market position. It covers items for work ability and self-rated health, for example, and summary scales for social, psychological, cognitive and physical functioning, as well as everyday skills. The aim of this study was to evaluate the intrarater test–retest reliability, internal consistency and basic psychometric properties of the Finnish version of the Abilitator.Design, setting and outcomeThe test–retest study was conducted in European Social Fund projects in 2018–2019. The participants completed two Abilitator questionnaires over 7–14 days. The internal consistency analysis was based on data collected in 2017–2019 in services for the long-term unemployed. The reliability was assessed using correlations (r, rs, intraclass correlation coefficient (ICC)), agreement with Bland-Altman analysis and internal consistency with Cronbach’s alpha.ParticipantsThe test–retest study had 67 participants (52% men, mean age 43.9 years) and the internal consistency study 10 923 (48% men, mean age 38.58 years), respectively. Of all the participants, 80% had been unemployed for over a year.ResultsThe test–retest r or rs ranged from 0.71 to 0.93 and ICC from 0.74 to 0.93 for the items and summary scales. An exception was the life satisfaction item, with an rs of 0.60 and ICC of 0.45. A statistically significant difference was observed in the summary scale for social functioning (t=−2.01, p=0.049). Agreement was observed for all variables except social functioning. Alphas for summary scales ranged from 0.74 to 0.91.ConclusionsThe Finnish version of the Abilitator is a reliable PROM for the target group and has acceptable to excellent intrarater test–retest reliability and internal consistency, apart from the life satisfaction item. Further testing is needed for the social functioning summary scale.

IntroductionPhysician interpersonal competence is crucial for patient care. How interpersonal competence develops during undergraduate medical education is thus a key issue. Literature on the topic consists predominantly of studies on empathy showing a trend of decline over the course of medical school. However, most existing studies have focused on narrow measures of empathy. The first aim of this project is to study medical students’ interpersonal competence with a comprehensive framework of empathy that includes self-reported cognitive and affective empathy, performance-based assessments of emotion recognition accuracy, and a behavioural dimension of empathy. The second aim of the present project is to investigate the evolution of mental health during medical school and its putative link to the studied components of interpersonal competence. Indeed, studies documented a high prevalence of mental health issues among medical students that could potentially impact their interpersonal competence. Finally, this project will enable to test the impact of mental health and interpersonal competence on clinical skills as evaluated by experts and simulated patients.Methods and analysisThis project consists of an observational longitudinal study with an open cohort design. Each year during the four consecutive years of the project, every medical student (curriculum years 1–6) of the University of Lausanne in Switzerland will be asked to complete an online questionnaire including several interpersonal competence and mental health measures. Clinical skills assessments from examinations and training courses with simulated patients will also be included. Linear mixed models will be used to explore the longitudinal evolutions of the studied components of interpersonal competence and mental health as well as their reciprocal relationship and their link to clinical skills.Ethics and disseminationThe project has received ethical approval from the competent authorities. Findings will be disseminated through internal, regional, national and international conferences, news and peer-reviewed journals.

IntroductionImproving body image may help to enhance the quality of life of women diagnosed with breast cancer. Although evidence suggests psychosocial interventions can effectively improve body image in this population, no review to date has assessed their feasibility or acceptability. This manuscript reports the protocol for a review summarising current evidence for the feasibility and acceptability of psychosocial interventions for body image targeting women diagnosed with breast cancer and the study methods used to evaluate the interventions in question to provide recommendations to optimise the success and sustainability of psychosocial interventions for body image and future studies. Results will also help to identify gaps in the existing evidence to provide direction for future research.Methods and analysisWe searched the following databases for articles published in the English language from January 2000 to June 2021 using a systematic search strategy: MEDLINE, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, PsychINFO and EMBASE. This search will be supplemented with a manual search of reference lists from relevant systematic reviews and included articles. Eligible studies will include peer-reviewed publications reporting on feasibility and acceptability in the evaluation of psychosocial interventions for body image targeting women diagnosed with breast cancer. All study designs are eligible, although articles are required to have reported on an intervention evaluation. Two reviewers will independently carry out study selection, extraction of quantitative and qualitative data and quality assessment. Data will be summarised in a narrative review and thematic analysis.Ethics and disseminationNo ethical approval is required because this is a protocol for a systematic review. On completion, results will be submitted for publication in a peer-reviewed scientific journal and for presentation at a relevant conference.Trial registrationThis protocol has been registered in the Prospective Register of Systematic Reviews international registry (ID: CRD42021269062, 11 September 2021).

ObjectiveAn intervention was carried out at the occupational healthcare services (OHS) of the City of Helsinki beginning in 2016. We investigated the association between the intervention and employee sick leaves using interrupted time series analysis.DesignRegister-based cohort study with a quasi-experimental study design.SettingEmployees of the City of Helsinki.ParticipantsWe analysed individual-level register-based data on all employees who were employed by the city for any length of time between 2013 and 2018 (a total 86 970 employees and 3 014 075 sick leave days). Sick leave days and periods that were OHS-based constituted the intervention time series and the rest of the sick leave days and periods contributed to the comparison time series.InterventionRecommendations provided to physicians on managing pain and prescribing sick leave for low back, shoulder and elbow pain.Outcome measuresNumber of sick leave days per month and sick leave periods per year.ResultsFor all sick leave days prescribed at OHS, there was no immediate change in sick leave days, whereas a gradual change showing decreasing number of OHS-based sick leave days was detected. On average, the intervention was estimated to have saved 2.5 sick leave days per year per employee. For other sick leave days, there was an immediate increase in the level of sick leave days after the intervention and a subsequent gradual trend showing decreasing number of sick leave days.ConclusionsThe intervention may have reduced employee sick leaves and therefore it is possible that it had led to direct cost savings. However, further evidence for causal inferences is needed.

ObjectivesTo evaluate a method of quantitative X-ray (QXR) for obtaining bone health information from standard radiographs aimed at identifying early signs of osteoporosis to enable improved referral and treatment. This QXR measurement is performed by postexposure analysis of standard radiographs, meaning bone health data can be acquired opportunistically, alongside routine imaging.DesignThe relationship between QXR and dual energy X-ray absorptiometry (DEXA) was demonstrated with a phantom study. A prospective clinical study was conducted to establish areal bone mineral density (aBMD) prediction model and a risk prediction model of a non-normal DEXA outcome. This was then extrapolated to a larger patient group with DEXA referral data.SettingSecondary care National Health Service Hospital.Participants126 consenting adult patients from a DEXA clinic.InterventionsAll participants underwent a DEXA scan to determine BMD at the lumbar spine (L2–L4) and both hips. An additional Antero-Posterior pelvis X-ray on a Siemens Ysio, fixed digital radiograph system was performed for the study.OutcomePerformance of QXR as a risk predictor for non-normal (osteoporotic) BMD.ResultsInterim clinical study data from 78 patients confirmed a receiver operator curve (area under the ROC curve) of 0.893 (95% CI 0.843 to 0.942) for a risk prediction model of non-normal DEXA outcome. Extrapolation of these results to a larger patient group of 11 029 patients indicated a positive predictive value of 0.98 (sensitivity of 0.8) for a population of patients referred to DEXA under current clinical referral criteria.ConclusionsThis study confirms that the novel QXR method provides accurate prediction of a DEXA outcome.Trial registration numberISRCTN98160454; Pre-results.

IntroductionTreatment of bipolar disorder is the focus of several clinical trials, however the understanding of the outcomes for establishing treatment effectiveness within these trials is limited. Further, there is limited literature which reports on the outcomes considered to be important to patients, indicating that patient perspectives are often not considered when selecting outcomes of effectiveness within trials. This protocol describes a systematic review which aims to describe the outcomes being used within trials to measure treatment effectiveness, commenting on the inclusion of patient-important outcomes within previous trials.Methods and analysisThis protocol is reported using the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols statement. OVID MEDLINE, OVID Embase, OVID APA PsycINFO, Web of Science, the Wiley Cochrane Library, ClinicalTrials.gov and the International Clinical Trials Registry Platform databases will be searched for eligible studies. Screening, full-text and data extraction stages will be completed in duplicate using the Covidence platform for systematic reviews. Eligible studies will include clinical trials of interventions in bipolar disorder, in order to identify outcomes used to assess treatment effectiveness, and qualitative studies, to determine which outcomes have been reported as important by patients. Risk of bias for included studies will be assessed using the Cochrane Risk of Bias Tool for randomised controlled trials, and the Newcastle-Ottawa Scale for observational research.Ethics and disseminationThis review will involve dissemination to key stakeholders, including primary end users such as patients, clinicians and trialists. Knowledge translation tools will be generated to share the relevant conclusions of this review. Results will be communicated to the scientific community through peer-reviewed publications, conferences and workshops. No ethics approval will be sought as this study is based on literature.PROSPERO registration numberCRD42021214435.

ObjectivesPrevious studies on depression in rural areas have yielded conflicting results. Features of rural areas may be conducive or detrimental to mental health. Our objective for this study was to determine if there are rural–urban disparities in depressive symptoms between those living in rural and urban areas of Canada.DesignWe conducted a cross-sectional analysis of a prospective cohort study, which is as representative as possible of the Canadian population—the Tracking Cohort of the Canadian Longitudinal Study on Aging. For this cohort, data were collected from 2010 to 2014. Data were analysed and results were obtained in 2020.Participants21 241 adults aged 45–85.MeasuresRurality was grouped as urban (n=11 772); peri-urban (n=2637); mixed (n=2125; postal codes with both rural and urban areas); and rural (n=4707). Depressive symptoms were measured using the 10-item Center for Epidemiological Studies-Depression. We considered age, sex, education, marital status and disease states as potential confounding factors.ResultsThe adjusted beta coefficient was −0.24 (95% CI −0.42 to −0.07; p=0.01) for rural participants, −0.17 (95% CI −0.40 to 0.05; p=0.14) for peri-urban participants and −0.30 (95% CI −0.54 to −0.05; p=0.02) for participants in mixed regions, relative to urban regions. Risk factors associated with depressive symptoms were similar in rural and urban regions.ConclusionsThe small differences in depressive symptoms among those living in rural and urban regions are unlikely to be relevant at a clinical or population level. The findings do suggest some possible approaches to reducing depressive symptoms in both rural and urban populations. Future research is needed in other settings and on change in depressive symptoms over time.

IntroductionMore research and policy action are needed to improve migrant health in areas such as sexual health and blood-borne viruses (SHBBV). While Knowledge, Attitudes and Practice Surveys (KAPS) can inform planning, there are no SHBBV KAPS suitable for use across culturally and linguistically diverse contexts. This study pretests one instrument among people born in Sub-Saharan Africa, South-East and North-East Asia living in Australia.MethodsEmployees of multicultural organisations were trained to collect data over three rounds using a hybrid qualitative pretesting method. Two researchers independently coded data. Researchers made revisions to survey items after each round. Responses to feedback questions in the final survey were analysed.ResultsSixty-two participants pretested the survey. Issues were identified in all three rounds of pretesting. Of the 77 final survey respondents who responded to a survey experience question, 21% agreed and 3% strongly agreed with the statement ‘I found it hard to understand some questions/words’.ConclusionIt is essential to pretest SHBBV surveys in migrant contexts. We offer the following pretesting guidance: (1) large samples are needed in heterogeneous populations; (2) intersectionality must be considered; (3) it may be necessary to pretest English language surveys in the participants’ first language; (4) bilingual/bicultural workers must be adequately trained to collect data; (5) results need to be interpreted in the context of other factors, including ethics and research aims; and (6) pretesting should occur over multiple rounds.

ObjectivesThe four SARS-CoV-2 variants of concern (VOC; Alpha, Beta, Gamma and Delta) identified by May 2021 are highly transmissible, yet little is known about their impact on public health measures. We aimed to synthesise evidence related to public health measures and VOC.DesignA rapid scoping review.Data sourcesOn 11 May 2021, seven databases (MEDLINE, Embase, the Cochrane Database of Systematic Reviews, Central Register of Controlled Trials, Epistemonikos’ L-OVE on COVID-19, medRxiv, bioRxiv) were searched for terms related to VOC, public health measures, transmission and health systems. No limit was placed on date of publication.Eligibility criteriaStudies were included if they reported on any of the four VOCs and public health measures, and were available in English. Only studies reporting on data collected after October 2020, when the first VOC was reported, were included.Data extraction and synthesisTitles, abstracts and full-text articles were screened by two independent reviewers. Data extraction was completed by two independent reviewers using a standardised form. Data synthesis and reporting followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.ResultsOf the 37 included studies, the majority assessed the impact of Alpha (n=32) and were conducted in Europe (n=12) or the UK (n=9). Most were modelling studies (n=28) and preprints (n=28). The majority of studies reported on infection control measures (n=17), followed by modifying approaches to vaccines (n=13), physical distancing (n=6) and either mask wearing, testing or hand washing (n=2). Findings suggest an accelerated vaccine rollout is needed to mitigate the spread of VOC.ConclusionsThe increased severity of VOC requires proactive public health measures to control their spread. Further research is needed to strengthen the evidence for continued implementation of public health measures in conjunction with vaccine rollout. With no studies reporting on Delta, there is a need for further research on this and other emerging VOC on public health measures.

ObjectivesTo summarise the current evidence regarding interventions for accurate and timely cancer diagnosis among symptomatic individuals.DesignA scoping review following the Joanna Briggs Institute’s methodological framework for the conduct of scoping reviews and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist.Data sourcesMEDLINE (Ovid), CINAHL (EBSCOhost) and PsycINFO (Ovid) bibliographic databases, and websites of relevant organisations. Published and unpublished literature (grey literature) of any study type in the English language were searched for from January 2017 to January 2021.Eligibility and criteriaStudy participants were individuals of any age presenting at clinics with symptoms indicative of cancer. Interventions included practice guidelines, care pathways or other initiatives focused on achieving predefined benchmarks or targets for wait times, streamlined or rapid cancer diagnostic services, multidisciplinary teams and patient navigation strategies. Outcomes included accuracy and timeliness of cancer diagnosis.Data extraction and synthesisWe summarised findings graphically and descriptively.ResultsFrom 21 298 retrieved citations, 88 unique published articles and 16 unique unpublished documents (on 18 study reports), met the eligibility for inclusion. About half of the published literature and 83% of the unpublished literature were from the UK. Most of the studies were on interventions in patients with lung cancer. Rapid referral pathways and technology for supporting and streamlining the cancer diagnosis process were the most studied interventions. Interventions were mostly complex and organisation-specific. Common themes among the studies that concluded intervention was effective were multidisciplinary collaboration and the use of a nurse navigator.ConclusionsMultidisciplinary cooperation and involvement of a nurse navigator may be unique features to consider when designing, delivering and evaluating interventions focused on improving accurate and timely cancer diagnosis among symptomatic individuals. Future research should examine the effectiveness of the interventions identified through this review.

BackgroundGaps in identification, medical management and appropriate referral for patients with chronic kidney disease (CKD) are evident.ObjectiveWe designed and implemented an interactive educational intervention (accredited workshop) to improve primary care providers’ awareness of tools to support guideline-concordant CKD management.DesignWe used the Kern method to design the educational intervention and targeted the accredited workshops to primary care team members (physicians, nurses and allied health) in Alberta, Canada. We conducted anonymous pre-workshop and post-workshop surveys to identify practice-specific barriers to care, identify potential solutions, and evaluate provider confidence pre-intervention and post-intervention. We used non-parametric statistics to analyse Likert-type survey data and descriptive content analysis to categorise responses to open-ended survey questions.ResultsWe delivered 12 workshops to 114 providers from September 2017 through March 2019. Significant improvements (pConclusionsThe Kern model was an effective methodology to design and implement an educational intervention to improve providers’ confidence in managing patients with CKD in primary care. Future research is needed to determine if these perceived knowledge and confidence improvements affect patient outcomes and whether improvements are sustained long term.

IntroductionMajor depressive disorder (MDD or depression) is prevalent among adults aged 65 years and older. The effectiveness and safety of interventions used to treat depression is often assessed through randomised controlled trials (RCTs). However, heterogeneity in the selection, measurement and reporting of outcomes in RCTs renders comparisons between trial results, interpretability and generalisability of findings challenging. There is presently no core outcome set (COS) for use in RCTs that assess interventions for older adults with MDD. We will conduct a methodological review of the literature for outcomes reported in trials for adults 65 years and older with depression to assess the heterogeneity of outcome measures.Methods and analysisRCTs evaluating pharmacotherapy, psychotherapy, or any other treatment intervention for older adults with MDD published in the last 10 years will be located using electronic database searches (MEDLINE, Embase, PsycINFO and the Cochrane Central Register of Controlled Trials). Reviewers will conduct title and abstract screening, full-text screening and data extraction of trials eligible for inclusion independently and in duplicate. Outcomes will be synthesised and mapped to core outcome-domain frameworks. We will summarise characteristics associated with trials and outcomes.Ethics and disseminationWe hope that findings from our methodological review will reduce variability in outcome selection, measurement and reporting and facilitate the development of a COS for older adults with MDD. Our review will also inform evidence synthesis efforts in identifying the best treatment practices for this clinical population. Ethics approval is not required, as this study is a literature review.PROSPERO registration numberCRD42021244753.

IntroductionThe global COVID-19 pandemic has reported to have a negative impact on the mental health and well-being of individuals around the world. Mental health system infrastructure, primarily developed to support individuals through in-person care, struggled to meet rising demand for services even prior to COVID-19. With public health guidelines requiring the use of physical distancing during the pandemic, digital mental health supports may be one way to address the needs of the population. Despite this, barriers exist in promoting and supporting access to existing and emerging digital resources. Text messaging may address some of these barriers, extending the potential reach of these digital interventions across divides that may separate some vulnerable or disadvantaged groups from essential mental health supports. Building on an existing knowledge synthesis project identifying key digital resources for improved mental health, this research will establish low-tech connections to assess need and better match access to services for those who need it most. The aim of this study is to codesign a customised two-way texting service to explore need and better align access to mental health supports for Canadians located in Saskatchewan during the COVID-19 pandemic.Methods and analysisThis study will be completed in Saskatchewan, Canada. For this project, the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework will be used to support three phases of a sequential mixed-method study. An advisory committee of Saskatchewan residents will guide this work with the study team. A 10-week service will be launched to connect individuals with appropriately suited digital mental health interventions through the use of text messaging. In phase 1, implementation and prototyping will be conducted with collaborative codesign for key elements related to features of an enrolment survey and initial messaging content. Phase 2 will focus on advancing the effectiveness of the service using quantitative user data. In phase 3, an embedding approach will be used to integrate both qualitative and quantitative data collected to understand the overall acceptability, satisfaction and perceived benefit of the text messaging service. Thematic analysis and descriptive statistics will be used as analytic methods.Ethics and disseminationThis study has received approval from the Research Ethics Board at the University of Saskatchewan. A knowledge dissemination plan has been developed that includes traditional academic approaches such as conference presentations, and academic publications, as well as mainstream approaches such as social media, radio and dissemination through the advisory committee.

IntroductionDevelopment of fully internet-based programs could provide a new avenue to improve access to healthcare for problem gamblers. In this project, we aim to assess the efficacy of a web-based cognitive intervention targeting inhibitory control among problem gamblers, using a randomised controlled design. As impaired inhibitory control is involved in self-regulation difficulties in behavioural addictions, it represents a particularly relevant cognitive process to target for an online psychological intervention.Methods and analysisThis will be a single-blinded, randomised, comparative therapeutic web-based, controlled trial. Up to 200 non-treatment seeking adult problem gamblers with a Problem Gambling Severity Index-recent (PGSI-recent) score ≥5 will be included. The intervention will be a computerised cognitive training program targeting inhibitory skills. The comparator, an active control, will be a computerised neutral sensorial program. Both programs will be carried out under similar conditions: biweekly online training for 6 weeks and optional telephone support will be offered to patients for debriefing. The main objective of the study is to assess the clinical efficacy of the online cognitive training program at 6 weeks, measured with the PGSI-recent. The secondary objectives are to assess the efficacy on the gambling behaviour assessed by the account-based gambling data, on the self-reported gambling practice, and on the inhibition performance at the neuropsychological level at 6, 14 and 52 weeks. We will also assess the acceptability of this program and the preferred level of guidance. Data analysis will be in intention-to-treat.Ethics and disseminationThis randomized controlled trial will be executed in compliance with the Helsinki Declaration, and was approved by the local ethics boards (Comité de Protection des Personnes) in October 2017. The findings will be published in peer-reviewed journals.Trial registration numberNCT03673800.

ObjectiveTo summarise the comparative risk of infection in school staff and their contribution to SARS-CoV-2 transmission.DesignSystematic review using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline.Data sourcesMEDLINE, WHO COVID-19 database and preView were searched on 29 January 2021.Eligibility criteriaWe included studies that reported risk of SARS-CoV-2 infection in school staff or transmission of SARS-CoV-2 in school settings.Data extraction and synthesisData extraction was done in duplicates. Data synthesis was qualitative. We report attack rates and infection risk in school settings for staff and students stratified by control measures taken and infection dynamics at the point of data collection.ResultsEighteen studies were included. Three studies in low incidence settings showed low attack rates similar for teachers and students. Five studies in medium incidence settings and two studies in high incidence settings showed secondary attack rates up to 16% in school staff.Seroprevalence studies, two in each low and high incidence settings showed an infection risk of 0%–0.2% and 1.7%–28% for teachers.The risk of infection for teachers compared with students were similar in one study in low incidence setting, higher in three studies (RR 1.2–4.4) and lower in three studies in medium to high incidence settings. The risk of infection for teachers in a high infection environment is higher in face-to-face than in distance classes when compared with general population groups. The risk of infections as well as risk of hospitalisation both increased for teachers during school openings compared with school closure.ConclusionWhile in low incidence settings there is little evidence for school staff to be at high risk of SARS-CoV-2 infection, in high incidence settings there is an increased risk of SARS-CoV-2 infection in school staff teaching face-to-face compared to staff teaching digitally and general population.PROSPERO registration numberCRD42021239225.

IntroductionOne of the known risk factors for fall incidents is the use of specific medications, fall-risk-increasing drugs (FRIDs). However, to date, there is uncertainty related to the effectiveness of deprescribing as a single intervention in falls prevention. Thus, a comprehensive update of the literature focusing on all settings in which older people receive healthcare and all deprescribing interventions is warranted to enhance the current knowledge.Methods and analysisThis systematic review protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A systematic search was performed in Cochrane Central Register of Controlled Trials, MEDLINE, Embase and PsycINFO (2 November 2020). We will also search in trial registers. We will include randomised controlled trials, in which any deprescribing intervention is compared with usual care and reports falls as an outcome. Both title and abstract screening and full-text screening will be done by two reviewers. The Cochrane Collaboration revised tool of Risk of Bias will be applied to perform risk of bias assessment. We will categorise the results separately for every setting. If a group of sufficiently comparable studies will be identified, we will perform a meta-analysis applying random effects model. We will investigate heterogeneity using a combination of visual inspection of the forest plot along with consideration of the χ2 test and the I2 statistic results. We have prespecified several subgroup and sensitivity analyses.Ethics and disseminationEthics approval is not applicable for this study since no original data will be collected. The results will be disseminated through peer-reviewed publication and conference presentations. Furthermore, this systematic review will inform the recommendations of working group of polypharmacy and FRIDs of the anticipated World’s Falls Guidelines.PROSPERO registration numberCRD42020218231.

ObjectivesNon-healthcare keyworkers face distinct occupational vulnerabilities that have received little consideration within broader debates about ‘essential’ work and psychological distress during the COVID-19 pandemic. The aim of this study was therefore to explore the impact of the pandemic on the working lives and mental health and well-being of non-healthcare keyworkers in the UK.DesignIn-depth, qualitative interviews, analysed using a reflexive thematic analysis.SettingTelephone or video call interviews, conducted in the UK between September 2020 and January 2021.Participants23 participants aged 26–61 (mean age=47.2) years employed in a range of non-healthcare keyworker occupations, including transport, retail, education, postal services, the police and fire services, waste collection, finance and religious services.ResultsKeyworkers experienced adverse psychological effects during the COVID-19 pandemic, including fears of COVID-19 exposure, contagion and subsequent transmission to others, especially their families. These concerns were often experienced in the context of multiple exposure risks, including insufficient personal protective equipment and a lack of workplace mitigation practices. Keyworkers also described multiple work-related challenges, including increased workload, a lack of public and organisational recognition and feelings of disempowerment.ConclusionsIn efforts to reduce psychosocial concerns among non-healthcare keyworkers, there is a need for appropriate support during the COVID-19 pandemic and in preparation for other infections (eg, seasonal influenza) in the future. This includes the provision of psychological and workplace measures attending to the intersections of personal vulnerability and work conditions that cause unique risks and challenges among those in frontline keyworker occupations.

IntroductionConsiderable observational evidence suggests that cancer online support groups reduce feelings of isolation, depression and anxiety, enhance coping and self-management, and lead to better informed patients. Other studies indicate that cancer online support groups can increase distress. Yet no studies theorise the complex, context-dependent mechanisms by which cancer online support groups generate their—sometimes contrasting—outcomes.Methods and analysisGuided by an integrated knowledge translation approach and the strategy for patient-oriented research, we will conduct a realist review of cancer online support groups in partnership with stakeholders. We will follow Pawson’s five steps and existing quality standards to develop a program theory that explains how cancer online support groups work, for whom and in what circumstances. The specific research questions will be: what positive and negative outcomes have been reported on cancer online support groups? What are the mechanisms that are associated with these outcomes, in which contexts and for whom? Through a rigorous review of relevant scientific and grey literature, as well as ongoing dialogue with stakeholders, a program theory will be developed to explain who benefits from cancer online support groups and who does not, what benefits they derive (or do not), and the factors that affect these outcomes.Ethics and disseminationThe use of secondary data for this review precludes the need for ethical approval. Dissemination will be informed by the knowledge-to-action framework and will consist of tailored knowledge products that are conceived of collaboratively with stakeholders. These will include peer-reviewed publications on how cancer online support groups can be optimised and best practice recommendations to maximise the benefits experienced by people with cancer. These traditional scientific outputs, along with their respective evidence summaries, will be amplified through strategic social media events hosted and promoted by knowledge users.PROSPERO registration numberCRD42021250046.

ObjectivesTo evaluate the relationship between markers of staff employment stability and use of short-term healthcare workers with markers of quality of care. A secondary objective was to identify clinic-specific factors which may counter hypothesised reduced quality of care associated with lower stability, higher turnover or higher use of short-term staff.DesignRetrospective cohort study (Northern Territory (NT) Department of Health Primary Care Information Systems).SettingAll 48 government primary healthcare clinics in remote communities in NT, Australia (2011–2015).Participants25 413 patients drawn from participating clinics during the study period.Outcome measuresAssociations between independent variables (resident remote area nurse and Aboriginal Health Practitioner turnover rates, stability rates and the proportional use of agency nurses) and indicators of health service quality in child and maternal health, chronic disease management and preventive health activity were tested using linear regression, adjusting for community and clinic size. Latent class modelling was used to investigate between-clinic heterogeneity.ResultsThe proportion of resident Aboriginal clients receiving high-quality care as measured by various quality indicators varied considerably across indicators and clinics. Higher quality care was more likely to be received for management of chronic diseases such as diabetes and least likely to be received for general/preventive adult health checks. Many indicators had target goals of 0.80 which were mostly not achieved. The evidence for associations between decreased stability measures or increased use of agency nurses and reduced achievement of quality indicators was not supported as hypothesised. For the majority of associations, the overall effect sizes were small (close to zero) and failed to reach statistical significance. Where statistically significant associations were found, they were generally in the hypothesised direction.ConclusionsOverall, minimal evidence of the hypothesised negative effects of increased turnover, decreased stability and increased reliance on temporary staff on quality of care was found. Substantial variations in clinic-specific estimates of association were evident, suggesting that clinic-specific factors may counter any potential negative effects of decreased staff employment stability. Investigation of clinic-specific factors using latent class analysis failed to yield clinic characteristics that adequately explain between-clinic variation in associations. Understanding the reasons for this variation would significantly aid the provision of clinical care in remote Australia.

ObjectiveTo describe the sociodemographic characteristics associated with e-cigarette ever use and to examine the impact of e-cigarette ever use on lung function impairment in an ageing population.DesignA cross-sectional analysis of data from the Canadian Longitudinal Study on Aging.SettingA national stratified sample of 44 817 adults living in Canadian provinces.ParticipantsRespondents included participants aged 45–85 and residing in the community in Canadian provinces.Outcome measuresThe Global Lung Function Initiative normative values for forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), forced expiratory ratio (FEV1/FVC) appropriate for age, sex, height and ethnicity were used to interpret the severity of lung function impairment. Multinomial logistic regression analysis was used to examine the impact of e-cigarette ever use on obstructive and restrictive lung function impairment.ResultsThe prevalence of e-cigarette ever use was 6.5% and varied by sociodemographic factors including higher prevalence among individuals younger than 65 years, those with lower education attainment and those with lower annual household income. E-cigarette ever use was associated with 2.10 (95% CI 1.57 to 2.08) times higher odds of obstructive lung function impairment after adjusting for conventional cigarette smoking and other covariates. Individuals with exposure to e-cigarette ever use and 15 or more pack-years had 7.43 (95% CI 5.30 to 10.38) times higher odds for obstructive lung function impairment when compared with non-smokers and non-e-cigarette users after adjusting for covariates. Smokers with 15 or more pack-years had higher odds of restrictive lung function impairment irrespective of e-cigarette ever use.ConclusionsEver use of e-cigarettes was found to be associated with obstructive lung function impairment after adjusting for covariates, suggesting that e-cigarette use may be adding to the respiratory and other chronic disease burden in the population.

ObjectivesTo investigate the association between changes in lifestyle risk factors and changes is sleep difficulties.DesignLongitudinal repeated measures cohort study.SettingUniversity and national institute of occupational health.ParticipantsParticipants of the Finnish Public Sector study with information on sleep and lifestyle-related risk factors collected in five repeat surveys with 4‐year intervals from 2000 to 2017. The participants were those, who had responded at least twice and had a change in sleep difficulties (having sleep difficulties vs not) (142 969 observations from 38 400 respondents (mean age 45.5 (SD 9.2) years, 83% women).Primary and secondary outcome measuresChanges in sleep quality over time. Longitudinal fixed effects analysis, a method that accounts for time-invariant confounders by design, was used.ResultsAt first available response, sleep difficulties were experienced by 13 998 (36%) of the respondents. Respectively, the mean age was 44.3 (10.0) years, 7526 (20%) were obese, 13 487 (35%) reported low physical activity, 3338 (9%) extensively drinking and 6547 (17%) were smoking. Except for smoking, the changes in the studied modifiable risks were associated with changes in sleep difficulties. The ORs for having sleep difficulties were 1.41 (95% CI 1.35 to 1.48) for obesity, 1.10 (95% CI 1.06 to 1.13) for low physical activity and 1.43 (95% CI 1.35 to 1.51) for heavy drinking. For smoking, the association was negative with OR 0.81 (95% CI 0.76 to 0.86). Including all four modifiable risks into model changed the estimates only little.ConclusionsThe results of this longitudinal study suggest that changes in sleep quality are interconnected with changes in lifestyle.

IntroductionThe effects of climate change and associated extreme weather events (EWEs) present substantial threats to well-being. EWEs hold the potential to harm sexual health through pathways including elevated exposure to HIV and other sexually transmitted infections (STIs), disrupted healthcare access, and increased sexual and gender-based violence (SGBV). The WHO defines four components of sexual health: comprehensive sexuality education; HIV and STI prevention and care; SGBV prevention and care; and psychosexual counselling. Yet, knowledge gaps remain regarding climate change and its associations with these sexual health domains. This scoping review will therefore explore the linkages between climate change and sexual health.Methods and analysisFive electronic databases (MEDLINE, EMBASE, PsycINFO, Web of Science, CINAHL) will be searched using text words and subject headings (eg, Medical Subject Headings (MeSH), Emtree) related to sexual health and climate change from the inception of each database to May 2021. Grey literature and unpublished reports will be searched using a comprehensive search strategy, including from the WHO, World Bank eLibrary, and the Centers for Disease Control and Prevention. The scoping review will consider studies that explore: (a) climate change and EWEs including droughts, heat waves, wildfires, dust storms, hurricanes, flooding rains, coastal flooding and storm surges; alongside (b) sexual health, including: comprehensive sexual health education, sexual health counselling, and HIV/STI acquisition, prevention and/or care, and/or SGBV, including intimate partner violence, sexual assault and rape. Searches will not be limited by language, publication year or geographical location. We will consider quantitative, qualitative, mixed-methods and review articles for inclusion. We will conduct thematic analysis of findings. Data will be presented in narrative and tabular forms.Ethics and disseminationThere are no formal ethics requirements as we are not collecting primary data. Results will be published in a peer-reviewed journal and shared at international conferences.

ObjectiveTo study participant’s acceptability of and attitudes towards human papillomavirus (HPV) testing compared with cytology for cervical cancer screening and what impact having an HPV positive result may have in future acceptability of screening.DesignCross-sectional online survey of clinical trial participants.SettingPrimary care, population-based Cervix Screening Program, British Columbia, Canada.ParticipantsA total of 5532 participants from the HPV FOCAL trial, in which women received HPV and cytology testing at study exit, were included in the analysis. Median age was 54 years. The median time of survey completion was 3 years after trial exit.Outcome measuresAcceptability of HPV testing for primary cervical cancer screening (primary); attitudes and patient perceptions towards HPV testing and receipt of HPV positive screen results (secondary).ResultsMost respondents (63%) were accepting of HPV testing, with the majority (69%) accepting screening to begin at age 30 years with HPV testing. Only half of participants (54%) were accepting of an extended screening interval of 4–5 years. In multivariable logistic regression, women who received an HPV positive screen test result during the trial (OR=1.41 95% CI 1.11 to 1.80) or were older (OR=1.01, 95% CI 1.00 to 1.02) were more likely to report HPV testing as acceptable.ConclusionsIn this evaluation of acceptability and attitudes regarding HPV testing for cervix screening, most are accepting of HPV testing for screening; however, findings indicate heterogeneity in concerns and experiences surrounding HPV testing and receipt of HPV positive results. These findings provide insights for the development of education, information and communication strategies during implementation of HPV-based cervical cancer screening.Trial registration numbersISRCTN79347302 and NCT00461760.

IntroductionPelvic organ prolapse (POP) is the descent of pelvic organs into the vagina resulting in bulge symptoms and occurs in approximately 50% of women. Almost 20% of women will elect surgical correction of this condition by age 85. Removal of the uterus (hysterectomy) with concomitant vaginal vault suspension is a long-standing practice in POP surgery to address apical (uterine) prolapse. Yet, contemporary evidence on the merits of this approach relative to preservation of the uterus through suspension is needed to better inform surgical decision making by patients and their healthcare providers. The objective of this study is to evaluate POP-specific health outcomes and service utilisation of women electing uterine suspension compared with those electing hysterectomy and vaginal vault suspension for POP surgery up to 1-year postsurgery.Methods and analysisThis is a prospective cohort study planning to enrol 321 adult women with stage ≥2 POP from multiple sites in Alberta, Canada. Following standardised counselling from study surgeons, participants self-select either a hysterectomy based or uterine preservation surgical group. Data are being collected through participant questionnaires, medical records and administrative data linkage at four time points spanning from the presurgical consultation to 1-year postsurgery. The primary outcome is anatomic failure to correct POP, and secondary outcomes include changes in positioning of pelvic structures, retreatment, subjective report of bulge symptoms, pelvic floor distress and impact, sexual function and health service use. Data will be analysed using inverse probability weighting of propensity scores and generalised linear models.Ethics and disseminationThis study is approved by the Conjoint Health Research Ethics Board at the University of Calgary (REB19-2134). Results will be disseminated via peer-reviewed publications, presentations at national and international conferences, and educational handouts for patients.Trial registration numberNCT04890951.

IntroductionBCG vaccination modulates immune responses to unrelated pathogens. This off-target effect could reduce the impact of emerging pathogens. As a readily available, inexpensive intervention that has a well-established safety profile, BCG is a good candidate for protecting healthcare workers (HCWs) and other vulnerable groups against COVID-19.Methods and analysisThis international multicentre phase III randomised controlled trial aims to determine if BCG vaccination reduces the incidence of symptomatic and severe COVID-19 at 6 months (co-primary outcomes) compared with no BCG vaccination. We plan to randomise 10 078 HCWs from Australia, The Netherlands, Spain, the UK and Brazil in a 1:1 ratio to BCG vaccination or no BCG (control group). The participants will be followed for 1 year with questionnaires and collection of blood samples. For any episode of illness, clinical details will be collected daily, and the participant will be tested for SARS-CoV-2 infection. The secondary objectives are to determine if BCG vaccination reduces the rate, incidence, and severity of any febrile or respiratory illness (including SARS-CoV-2), as well as work absenteeism. The safety of BCG vaccination in HCWs will also be evaluated. Immunological analyses will assess changes in the immune system following vaccination, and identify factors associated with susceptibility to or protection against SARS-CoV-2 and other infections.Ethics and disseminationEthical and governance approval will be obtained from participating sites. Results will be published in peer-reviewed open-access journals. The final cleaned and locked database will be deposited in a data sharing repository archiving system.Trial registrationClinicalTrials.gov NCT04327206

IntroductionThere is widespread agreement that medical care without compassion cannot be patient-centred, but patients still routinely cite that they feel a lack of compassion in the care environment. There is a dearth of research on how compassion is experienced in a non-hospital setting such as a care home, not just by residents but by staff and other key stakeholders. This scoping review aims to determine the body of existing, published research that explicitly refers to compassion or empathy in the context of care homes.Methods and analysisThis scoping review will follow the methodology described by Arksey and O’Malley and the PRISMAextension for scoping reviews guideline to adhere to an established methodological framework. Relevant publications will be searched on the EMBASE, MEDLINE, PubMed, CINAHL, EBM Reviews and PsycInfo databases. Peer-reviewed literature focusing on experiences of compassion or empathy in care home settings from the perspective of either staff, residents (or clients), family members or their combined perspectives will be included. We will focus on literature published from 2000 up to 1 November 2021, in English, Spanish, Portuguese Finnish and Estonian. The review process will consist of three stages: a title review to identify articles of interest, this will be followed by an abstract review and finally, a full-text review. These three stages will be conducted by two reviewers. Data will be extracted, collated and charted and a narrative synthesis of the results will be presented.Ethics and disseminationEthical approval is not required for this scoping review. This study supports the first part of a larger programme to understand the importance of technologies in care homes. The scoping review will examine data from publicly available documentation, reports and published papers. Dissemination will be achieved through engagement with stakeholder communities, and publishing results. Our team will include representatives from the different communities involved.

ObjectivesThis study explores the hospital journey of patients with intellectual disabilities (IDs) compared with the general population after admission for COVID-19 during the first wave of the pandemic (when demand on inpatient resources was high) to identify disparities in treatment and outcomes.DesignMatched cohort study; an ID cohort of 506 patients were matched based on age, sex and ethnicity with a control group using a 1:3 ratio to compare outcomes from the International Severe Acute Respiratory and emerging Infections Consortium WHO Clinical Characterisation Protocol UK.SettingAdmissions for COVID-19 from UK hospitals; data on symptoms, severity, access to interventions, complications, mortality and length of stay were extracted.InterventionsNon-invasive respiratory support, intubation, tracheostomy, ventilation and admission to intensive care units (ICU).ResultsSubjective presenting symptoms such as loss of taste/smell were less frequently reported in ID patients, whereas indicators of more severe disease such as altered consciousness and seizures were more common. Controls had higher rates of cardiovascular risk factors, asthma, rheumatological disorder and smoking. ID patients were admitted with higher respiratory rates (median=22, range=10–48) and were more likely to require oxygen therapy (35.1% vs 28.9%). Despite this, ID patients were 37% (95% CI 13% to 57%) less likely to receive non-invasive respiratory support, 40% (95% CI 7% to 63%) less likely to receive intubation and 50% (95% CI 30% to 66%) less likely to be admitted to the ICU while in hospital. They had a 56% (95% CI 17% to 102%) increased risk of dying from COVID-19 after they were hospitalised and were dying 1.44 times faster (95% CI 1.13 to 1.84) compared with controls.ConclusionsThere have been significant disparities in healthcare between people with ID and the general population during the COVID-19 pandemic, which may have contributed to excess mortality in this group.

IntroductionDuring pregnancy, maternal obesity increases the risk of fetal abnormalities. Despite advances in ultrasound imaging, the assessment of fetal anatomy is less thorough among these women. Currently, the construction of ultrasound images uses a conventional ultrasound propagation velocity (1540 m/s), which does not correspond to the slower speed of propagation in fat tissue.The main objective of this randomised study is to compare the completeness of fetal ultrasonography according to whether the operator could choose the ultrasound velocity (1420, 1480 or 1540 m/s) or was required to apply the 1540 m/s velocity.Methods and analysisThis randomised trial is an impact study to compare a diagnostic innovation with the reference technique. The trial inclusion criteria require that a pregnant woman with obesity be undergoing a fetal morphology examination by ultrasound from 20+0 to 25+0 gestational weeks.Randomisation will allocate women into two groups. The first will be the ‘modulable speed’ group, in which operators can choose the speed of ultrasound propagation to be considered for the morphological analysis: 1420, 1480 or 1540 m/s. In the second ‘conventional speed’ group, operators will perform the morphological examination with the ultrasound speed fixed at 1540 m/s. The adjudication committee, two independent experts, will validate the completeness of each examination and the quality of the images.Ethics and disseminationThis research protocol does not change the standard management. The only possible impact is an improvement of the ultrasound examination by improving the quality of the image and the completeness of morphological examination. The Agence du Médicament et produits de santé approved this study (2018-A03478-47). The anonymised data will be available on request from the principal investigator. Results will be reported in peer-reviewed journals and at scientific meetings.Trial registration numberClinicalTrials.gov (http://www.clinicaltrials.gov) Registry (NCT04212234).

IntroductionThe COVID-19 pandemic is likely to have a prolonged impact on mental health (MH); however, the long-term MH effects of the COVID-19 pandemic remain unknown. The Serbian national survey—CoV2Soul.RS—was launched to document the MH status of the Serbian population following the COVID-19 pandemic and to contribute to an international evidence base about MH prevalence rates during different phases of the pandemic.Methods and analysisThis cross-sectional study was designed to collect a nationally representative sample (N=1200; age 18–65 years; estimated start/end—June/November 2021) using multistage probabilistic household sampling. Trained staff will conduct in-person diagnostic interviews. A battery of self-report instruments will be administered to assess the quality of life (QoL), general distress and associated protective and harmful psychological and societal factors. Analyses will be conducted to delineate the prevalence rates of MH disorders, how MH conditions and QoL vary with respect to sociodemographic variables, personality, health status and traumatic events during the COVID-19 pandemic, and to test how these relations depend on geographical region. Moreover, this study was designed to explore mechanisms linking personality and the perception of pandemic consequences and associated distress. Prevalence rates of MH disorders will be calculated using descriptive statistics. For additional analyses, we will use correlations, analysis of variance and regression analyses. The hierarchical structure of the data will be explored using multilevel random coefficient modelling. Structural equation modelling will be used to investigate the indirect effects of personality on distress through relevant variables.Ethics and disseminationEthical Committees of the Faculty of Medicine (1322-VII/31) and Faculty of Philosophy in Belgrade (02-33/273) and Faculty of Philosophy in Novi Sad (05-27, br.893/1) approved the protocol. Only respondents able to provide informed consent will participate in the study. Research reports will be submitted to peer-reviewed journals and the results will be placed on the website www.cov2soul.rs to be available to funders, researchers, policy-makers and interested laypeople, and will be advertised through social media.Trial registration numberNCT04896983.

IntroductionThe use of peripheral indwelling arterial catheter for haemodynamic monitoring is widespread in the intensive care unit and is recommended in patients with shock. However, there is no evidence that the arterial catheter could improve patient’s outcome, whereas the burden of morbidity generated is significant (pain, thrombosis, infections). We hypothesise that patients with shock may be managed without an arterial catheter.Methods and analysisThe EVERDAC study is an investigator-initiated, pragmatic, multicentre, randomised, controlled, open-label, non-inferiority clinical trial, comparing a less invasive intervention (ie, no arterial catheter insertion until felt absolutely needed, according to predefined safety criteria) or usual care (ie, systematic arterial catheter insertion in the early hours of shock). 1010 patients will be randomised with a 1:1 ratio in two groups according to the strategy. The primary outcome is all-cause mortality by 28 days after inclusion. A health economic analysis will be carried out.Ethics and disseminationThe study has been approved by the Ethics Committee (Comité de Protection des Personnes Île de France V, registration number 61606 CAT 2, 19 july 2018) and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT03680963.

IntroductionDecades of research demonstrate that First Nations, Metis and Inuit (FN/M/I) populations have differential access to diagnostic and therapeutic healthcare. Emerging evidence shows that this continues to be the case during the SARS-CoV-2 pandemic. In an effort to rectify these differences in access to care, our team, which is co-led by FN/M/I partners, will generate and distribute evidence on COVID-19 diagnostic testing and vaccination in high-priority FN/M/I populations in Manitoba, with the goal of identifying system-level and individual-level factors that act as barriers to equitable care and thereby informing Indigenous-led public health responses.Methods and analysisOur nations-based approach focuses on FN/M/I populations with separate study arms for each group. Linked administrative health data on COVID-19 diagnostic testing and vaccinations are available on a weekly basis. We will conduct surveillance to monitor trends in testing and vaccination among each FN/M/I population and all other Manitobans, map the geographic distribution of these outcomes by health region and tribal council, and identify barriers to testing and vaccination to inform public health strategies. We will follow the course of the pandemic starting from January 2020 and report findings quarterly.Ethics and disseminationEthics approvals have been granted by the University of Manitoba Research Ethics Board and from each of our FN/M/I partners’ organisations. Our team is committed to engaging in authentic relationship-based research that follows First Nations, Metis and Inuit research ethics principles. Our FN/M/I partners will direct the dissemination of new information to leadership in their communities (health directors, community health organisations) and to decision-makers in the provincial Ministry of Health. We will also publish in open-access journals. The study will create ongoing capacity to monitor Manitoba’s pandemic response and ensure potential health inequities are minimised, with learnings applicable to other jurisdictions where detailed administrative data may not be available.

IntroductionAssessment of decision-making capacity (DMC) is essential in daily life as well as for defining a person-centred care plan. Nevertheless, in ageing, especially if signs of dementia appear, it becomes difficult to assess decision-making ability and raises ethical questions. Currently, the assessment of DMC is based on the clinician’s evaluation, completed by neuropsychological tests. Functional MRI (fMRI) could bring added value to the diagnosis of DMC in difficult situations.Methods and analysisIMAGISION is a prospective, monocentric, single-arm study evaluating fMRI compared with clinical assessment of DMC. The study will begin during Fall 2021 and should be completed by Spring 2023. Participants will be recruited from a memory clinic where they will come for an assessment of their cognitive abilities due to decision-making needs to support ageing in place. They will be older people over 70 years of age, living at home, presenting with a diagnosis of mild dementia, and no exclusion criteria of MRI. They will be clinically assessed by a geriatrician on their DMC, based on the neuropsychological tests usually performed. Participants will then perform a behavioural task in fMRI (Balloon Analogue Risk Task) to analyse the activation areas. Additional semistructured interviews will be conducted to explore real life implications. The main analysis will study concordance/discordance between the clinical classification and the activation of fMRI regions of interest. Reclassification as ‘capable’, based on fMRI, of patients for whom clinical diagnosis is ‘questionable’ will be considered as a diagnostic gain.Ethics and disseminationIMAGISION has been authorised by a research ethics board (Comité de Protection des Personnes, Bordeaux, II) in France, in accordance with French legislation on interventional biomedical research, under the reference IDRCB number 2019-A00863-54, since 30 September 2020. Participants will sign an informed consent form. The results of the study will be presented in international peer-reviewed scientific journals, international scientific conferences and public lectures.Trial registration numberNCT03931148

In a cluster randomised trial (CRT), intact groups—such as communities, clinics or schools—are randomised to the study intervention or control conditions. The issue of informed consent in CRTs has been particularly challenging for researchers and research ethics committees. Some argue that cluster randomisation is a reason not to seek informed consent from research participants. In fact, systematic reviews have found that, relative to individually randomised trials, CRTs are associated with an increased likelihood of inadequate reporting of consent procedures and inappropriate use of waivers of consent. The objective of this paper is to clarify this confusion by providing a practical and useful framework to guide researchers and research ethics committees through consent issues in CRTs. In CRTs, it is the unit of intervention—not the unit of randomisation—that drives informed consent issues. We explicate a three-step framework for thinking through informed consent in CRTs: (1) identify research participants, (2) identify the study element(s) to which research participants are exposed, and (3) determine if a waiver of consent is appropriate for each study element. We then apply our framework to examples of CRTs of cluster-level, professional-level and individual-level interventions, and provide key lessons on informed consent for each type of CRT.

ObjectivesTo provide a consensus from a panel of international experts about electronic nicotine delivery systems (ENDS) and heated tobacco products (HTP).DesignCross-sectional survey.MethodsA Delphi survey was conducted among international experts in tobacco control and smoking cessation. The first part addressed statements or recommendations about ENDS, the second about HTP, both divided into four categories: regulation, sale, use and general issues.SettingExperts from 15 countries.ParticipantsIndividuals with clinical, public health or research expertise in tobacco control and/or smoking cessation.Results268 experts were contacted, 92 (34%) completed the first, 55/92 (60%) the second round. Consensus for ENDS: components of e-liquids, an upper limit of nicotine concentration should be defined; a warning on the lack of evidence in long-term safety and addiction potential should be stated; ENDS should not be regulated as consumer products but either as a new category of nicotine delivery or tobacco products; ENDS should not be sold in general stores but in specialised shops, shops selling tobacco or in pharmacies with restriction on sale to minors; administration of illegal drugs is likely with ENDS. Consensus for HTP: HTP have the same addictive potential as cigarettes; they should be regulated as a tobacco product with similar warning messages as cigarettes; their advertisement should not be allowed. ENDS and HTP use should not be allowed in indoor public places; a specific tax should be implemented for ENDS, taxes on HTP should not be lower than those for cigarettes; use of cigarettes is more likely with both ENDS and HTP (dual use) than quitting smoking.ConclusionsExperts in tobacco control and/or smoking cessation recommend differential regulation for ENDS and HTP. The results of this survey may be useful for health authorities, decision makers and researchers of the tobacco use and cessation field.

ObjectivesMultimorbidity is associated with mortality in high-income countries. Our objective was to investigate the relationship between multimorbidity (≥2 of the following chronic medical conditions: hypertension, diabetes, dyslipidaemia, anaemia, HIV, angina, depression, post-traumatic stress disorder, alcohol dependence) and all-cause mortality in an older, rural black South African population. We further investigated the relationship between HIV multimorbidity (HIV as part of the multimorbidity cluster) and mortality, while testing for the effect of frailty in all models.DesignPopulation cohort study.SettingAgincourt subdistrict of Mpumalanga province, South Africa.Participants4455 individuals (54.7% female), aged ≥40 years (median age 61 years, IQR 52–71) and resident in the study area.Primary and secondary outcome measuresThe primary outcome measure was time to death and the secondary outcome measure was likelihood of death within 2 years of the initial study visit. Mortality was determined during annual population surveillance updates.Results3157 individuals (70.9%) had multimorbidity; 29% of these had HIV. In models adjusted for age and sociodemographic factors, multimorbidity was associated with greater risk of death (women: HR 1.72; 95% CI: 1.18 to 2.50; men: HR 1.46; 95% CI: 1.09 to 1.95) and greater odds of dying within 2 years (women: OR 2.34; 95% CI: 1.32 to 4.16; men: OR 1.51; 95% CI: 1.02 to 2.24). HIV multimorbidity was associated with increased risk of death compared with non-HIV multimorbidity in men (HR 1.93; 95% CI: 1.05 to 3.54), but was not statistically significant in women (HR 1.85; 95% CI: 0.85 to 4.04); when detectable, HIV viral loads were higher in men (p=0.021). Further adjustment for frailty slightly attenuated the associations between multimorbidity and mortality risk (women: HR 1.55; 95% CI: 1.06 to 2.26; men: HR 1.36; 95% CI: 1.01 to 1.82), but slightly increased associations between HIV multimorbidity and mortality risk.ConclusionsMultimorbidity is associated with mortality in this older black South African population. Health systems which currently focus on HIV should be reorganised to optimise identification and management of other prevalent chronic diseases.

ObjectivesWe draw on institutional theory to explore the roles and actions of innovation teams and how this influences their behaviour and capabilities as ‘institutional entrepreneurs (IEs)’, in particular the extent to which they are both ‘willing’ and ‘able’ to facilitate transformational change in healthcare through service redesign.DesignA longitudinal qualitative study that applied a ‘researcher in residence’ as an ethnographic approach.SettingThe development and implementation of two innovation projects within a single public hospital setting in an Australian state jurisdiction.ParticipantsTwo innovation teams, with members including senior research fellows, PhD scholars and front-line clinicians (19 participants and 47 interviews).ResultsDespite being from the same hospital, the two innovation teams occupied contrasting subject positions with one facilitating transformational improvements in service delivery, while the other sought more conservative improvements. Cast as ‘IEs’ we show how one team took steps to build legitimacy for their interventions enabling spread and scale in improvements and how, in the other case, failure to build legitimacy resulted in unintended consequences which undermined the sustainability of the improvements achieved.ConclusionsAdopting an institutional approach provided insight into the ‘willingness’ and ‘ability’ to facilitate transformational change in healthcare through service redesign. The manner in which innovation teams operate from different subject positions influences the structural and normative legitimacy afforded to their activities. Specifically, we observed that those with the most power (organisational or professional) to bring about transformational change can be the least willing to do so in ways which challenge current practice. Those most willing to challenge the status quo (more peripheral organisation members or professionals) can be least able to deliver transformation. Better understanding of these insights can inform healthcare leaders in supporting innovation team efforts, considering their subject position.

IntroductionAfter deep vein thrombosis, up to 50% of patients develop post-thrombotic syndrome (PTS). PTS is a chronic condition that reduces quality of life (QOL). Cornerstones of PTS treatment include the use of elastic compression stockings but this treatment is usually incompletely effective and is burdensome. Venoactive drugs have been reported to be effective to treat chronic venous insufficiency (CVI). However, the level of evidence supporting their use in CVI in general and in PTS in particular is low.Methods and analysisThe MUFFIN-PTS trial is an academic, publically funded, multicentre randomised placebo-controlled trial assessing the efficacy of micronised purified flavonoid fraction (MPFF, Venixxa), a venoactive drug, to treat PTS. Eighty-six patients with PTS (Villalta score (VS) ≥5) and experiencing at least two of the following PTS manifestations among daily leg heaviness, cramps, pain or oedema will be randomised to receive 1000 mg of oral MPFF or a similar appearing placebo for 6 months, in addition to their usual PTS treatment. Total study follow-up will be 9 months, with visits at inclusion/baseline, 3, 6 and 9 months. Primary outcome is the proportion of patients with improvement in VS in each group, where improvement is defined as a decrease of at least 30% in VS or a VS Ethics and disseminationPrimary ethics approval was received from Centre intégré universitaire de santé et de services sociaux (CIUSSS) West-Central Montreal Research Ethics Board. Results of the study will be disseminated via peer-reviewed publications and presentations at scientific conferences.Trial registration numberClinicalTrials.gov Registry (NCT03833024); Pre-results.

BackgroundThe objective of this rapid scoping review was to identify studies of dose-sparing strategies for administration of intramuscular seasonal influenza vaccines in healthy individuals of all ages.MethodsComprehensive literature searches were executed in MEDLINE, Embase and the Cochrane library. The grey literature was searched via international clinical trial registries for relevant studies published in English in the last 20 years. We included studies in healthy humans of any age that used any dose-sparing strategy to administer intramuscular seasonal influenza vaccines. Title/abstract and full-text screening were carried out by pairs of reviewers independently. Data extraction was conducted by a single reviewer and verified by a second reviewer. Our outcomes were influenza infections, intensive care unit admission, pneumonia, hospitalisations, adverse events and mortality. Results were summarised descriptively.ResultsA total of 13 studies with 10 351 participants were included in the review and all studies were randomised controlled trials (RCTs) conducted between 2006 and 2019. The most common interventions were the trivalent influenza vaccine (n=10), followed by the quadrivalent influenza vaccine (n=4). Nine studies included infants/toddlers 6–36 months old and one of these studies also included children and adolescents. In these nine studies, no clinical effectiveness outcomes were reported. Of the four adult studies (≥18 years), two studies reported on effectiveness outcomes, however, only one RCT reported on laboratory-confirmed influenza.ConclusionsDue to the low number of studies in healthy adults and the lack of studies assessing confirmed influenza and influenza-like illness, there remains a need for further evaluation.

ObjectivesThe COVID-19 pandemic threatens to widen existing gender inequities worldwide. A growing body of literature assesses the harmful consequences of public health emergencies (PHEs) for women and girls; however, evidence of what works to alleviate such impacts is limited. To inform viable mitigation strategies, we reviewed the evidence on gender-based interventions implemented in PHEs, including disease outbreaks and natural disasters.MethodsWe conducted a rapid scoping review to identify eligible studies by systematically searching the databases MEDLINE, Global Health and Web of Science with the latest search update on 28 May 2021. We used the Sustainable Development Goals as a guiding framework to identify eligible outcomes of gender (in)equality.ResultsOut of 13 920 records, 16 studies met our eligibility criteria. These included experimental (3), cohort (2), case–control (3) and cross-sectional (9) studies conducted in the context of natural disasters (earthquakes, droughts and storms) or epidemics (Zika, Ebola and COVID-19). Six studies were implemented in Asia, seven in North/Central America and three in Africa. Interventions included economic empowerment programmes (5); health promotion, largely focused on reproductive health (10); and a postearthquake resettlement programme (1). Included studies assessed gender-based outcomes in the domains of sexual and reproductive health, equal opportunities, access to economic resources, violence and health. There was a dearth of evidence for other outcome domains relevant to gender equity such as harmful practices, sanitation and hygiene practices, workplace discrimination and unpaid work. Economic empowerment interventions showed promise in promoting women’s and girls’ economic and educational opportunities as well as their sexual and reproductive health during PHEs. However, some programme beneficiaries may be at risk of experiencing unintended harms such as an increase in domestic violence. Focused reproductive health promotion may also be an effective strategy for supporting women’s sexual and reproductive health, although additional experimental evidence is needed.ConclusionsThis study identified critical evidence gaps to guide future research on approaches to alleviating gender inequities during PHEs. We further highlight that interventions to promote gender equity in PHEs should take into account possible harmful side effects such as increased gender-based violence.Review registrationDOI 10.17605/OSF.IO/8HKFD.

ObjectiveWe aimed to estimate the distribution of health-related behaviours and dietary habits by sociodemographics among public workers in China.DesignCross-sectional study.SettingA representative sample was obtained from 10 government-run institutions in Hunan province of China.ParticipantsA total of 5029 public workers were included in this study.Primary and secondary outcome measuresPrevalence on their sociodemographic characteristics, health-related behaviours and dietary habits. Socioeconomic status (SES) scores were calculated by multiplying ordinal numerical values assigned to consecutive categories of education level and annual household income. Multivariate logistic regression analysis and categorical principal component analysis were used to estimate differences in health-related behaviours and dietary habits by sociodemographics.ResultsThe distribution of health-related behaviours and dietary habits was varied by sociodemographic groups. Middle-aged groups (41–60 years) were more likely to smoke (for men, 34.5%), use alcohol (for men, 22.5%), and have short sleep duration (for men, 36.3%; for women, 39.6%). Young participants (≤30 years) were more likely to have multiple unhealthy behaviours and dietary habits. Those in low-SES have a significant higher rate of smoking (ORadj=1.46, 95% CI: 1.15 to 1.85) and leisure-time physical inactivity (ORadj=1.18, 95% CI: 1.02 to 1.37), but a lower rate of late sleeping (ORadj=0.69, 95% CI: 0.57 to 0.83) than those in high-SES. Notably, older men (≥51 years) with low-SES preferred the ‘smoked and pickled foods and dessert’ and ‘fish and nut’ pattern. In high-SES groups, 41–50 year old people preferred the ‘traditional foods’ and ‘cereals and dairy product’ pattern. No difference in dietary patterns by sociodemographics was found among women (pConclusionsOur findings of the disparity distribution of health-related behaviours and dietary habits by specific gender, age and SES among Chinese public workers have important policy implications for developing targeted health interventions to facilitate health-related behaviours and dietary habits in this population.

ObjectivesThe objective was to examine care willingness and demand of residents under 60 years of age after retirement.SettingThe staged cluster sampling method was used between August and October 2018 in Dujiangyan, Sichuan Province, China.Participants2282 participants under 60 years of age were surveyed in 2018 by the staged cluster sampling method in China.Primary and secondary outcome measuresThe results of care willingness and demand were assessed by multiple comparisons of χ2 test and multivariable logistic regression.ResultsThe respondents who preferred institution-based care, home-based care and community-based care accounted for 39.5%, 38.3% and 20.2% respectively, whereas only 2.1% preferred home-based self-care. The main reasons for the respondents to choose institution-based care included better medical care (31.9%), better daily care (27.0%), burden reduction for children (26.3%), better accommodation (22.8%), satisfied living environment (21.6%) and low consumption (12.3%). The factors that affected care willingness and demand included age, ethnicity, educational attainment, marital status, occupation and the current type of residence.ConclusionsThe results revealed the care willingness and demand of residents under 60 years of age after retirement and relevant decision factors. This study provides a certain theoretical and practical significance for the development of the care willingness mode and promotes the cognition of policy-makers and researchers, and also provides the basis for decision-making.

BackgroundAllostatic load (AL) has shown that high burden of AL is associated with increased risk of adverse outcomes, but little attention has been paid to China with largest ageing population in the world.ObjectiveThis study is to examine the association between AL and all-cause mortality among Chinese adults aged at least 60 years.DesignPopulation-based prospective cohort study.SettingIn 2011–2012, an ancillary study, in which a blood test was added, including a total of 2439 participants, was conducted in eight longevity areas in the Chinese Longitudinal Healthy Longevity Survey.ParticipantsThe final analytical sample consisted of 1519 participants (mean±SD age: men 80.5±11.3 years; women 90.2±11.8 years and 53% women).Primary outcome measureCox models were used to examine the association between AL and mortality among men and women, separately. Analyses were also adjusted for potential confounders including age, ethnicity, education and marital status, smoking and exercise.ResultsMale with a medium AL burden (score: 2–4) and high AL burden (score: 5–9) had a 33% and 118% higher hazard of death, respectively, than those with a low AL burden (score: 0–1). We did not find significant difference between females with different levels of AL burden.ConclusionHigher AL burden was associated with increased all-cause mortality among Chinese men aged at least 60 years. However, we did not find strong association among women. In conclusion, Intervention programmes targeting modifiable components of the AL burden may help prolong lifespan for older adults, especially men, in China.