BMJ Open最新文献

Introduction: The Mobile Health (mHealth) Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO) study addresses the increasing prevalence of dementia among populations with lower socio-economic status (SES) and/or a migration background. The study aims to evaluate the effectiveness and implementation of an mHealth intervention designed for self-managing lifestyle modifications with remote coaching to reduce dementia risk factors.

Methods and analysis: This prospective randomised open-label blinded end point (PROBE) trial follows a type 2 hybrid effectiveness-implementation design with a 12-month intervention period. It aims to recruit 692 participants in Dutch primary care. Entry criteria include age 50-75 years, low SES and/or migration background, one or more dementia risk factors (hypertension, dyslipidaemia, diabetes mellitus, physical inactivity, smoking, depression and overweight) or manifest cardiovascular disease and possession of a smartphone. Participants are randomised to a coach-supported, interactive app facilitating self-management of dementia risk factors or to a control app with static health information. The primary effectiveness outcome is a composite score of systolic blood pressure, non-high-density lipoprotein cholesterol and body mass index. Implementation outcomes include coverage, adoption, acceptability, appropriateness, feasibility, fidelity, costs and sustainability of the intervention. Secondary outcomes include the Cardiovascular Risk Factors, Ageing and Dementia risk score and its individual risk factors, and disability, physical activity, depressive symptoms, cognitive functioning and daily distance moved.

Ethics and dissemination: The MIND-PRO trial is funded by the Netherlands Organisation for Health Research and Development (ZonMw, grant number 10510032120004) and approved by the Ethics Committee of Amsterdam UMC (reference: METC 2023.0770). Results are expected in 2026 and will be submitted for publication in a peer-reviewed journal, and presented at scientific conferences.

Trial registration number: ISRCTN92928122.

Objectives: To describe the use of days alive and out of hospital (DAOH) as a sensitive measure of equity of outcomes after surgery by comparing outcomes after a coronary artery bypass grafts (CABG) operation between Māori and non-Māori patients in Aotearoa New Zealand.

Primary and secondary outcome measures: We calculated unadjusted and risk-adjusted DAOH scores at three time points (30, 90 and 365 days) and compare values between Māori and non-Māori using data from the New Zealand Ministry of Health (MoH) over a 9 year period. To assess the impact of different risk factors on differences in outcome, we risk-adjust for multiple factors individually and collectively, to begin to elucidate possible pathways for equity gaps.

Results: After our comparisons, Māori patients experienced fewer unadjusted DAOH₉₀ at seven out of nine deciles. After risk-adjustment, the differences ranged from 8 days to 0 days when considering different risk factors. The equity gap was widest at the lower deciles and was most reduced after adjusting for the Measuring Multi Morbidity (M3) score. The equity gap widened as the time period extended from 30 to 90 to 365 days.

Conclusion: Māori patients who underwent a CABG operation experienced fewer DAOH than non-Māori patients even after adjusting for multiple possible explanatory variables, and this difference increased over time postoperatively. Importantly, our results illustrate the value of DAOH as a sophisticated outcome metric that can reflect the complex and accumulative impacts of disadvantage and discrimination faced by Indigenous peoples both here in New Zealand and worldwide. It has considerable potential to increase our understanding of how and where inequities arise on the entire patient journey.

Objective: This study aimed to investigate the trends and factors associated with congenital anomalies (CAs) among newborns in Eastern Ethiopia from 2015 to 2022.

Design: Open cohort study.

Setting: The Kersa Health and Demographic Surveillance System (KHDSS), which is located in the Kersa district of the Oromia region in Eastern Ethiopia, covering 24 kebeles.

Population: Newborns registered at birth in the database of the KHDSS site in Eastern Ethiopia.

Methods: The KHDSS tracks demographic and health changes in the community. Newborn data were extracted using a checklist. Trends in CAs over time (in years) were analysed and the associated factors were identified through logistic regression analysis.

Outcome measure: Newborn CAs, which are structural or functional abnormalities present at birth, were assessed through thorough physical examinations and detailed interviews conducted by trained data collectors using a standardised questionnaire.

Results: Between 2015 and 2022, a total of 27 350 newborns were recorded in the KHDSS, 104 of whom had CAs. The overall rate of CAs was 3.83 per 1000 live births (95% CI 3.19, 4.61). There was a significant increase in the trend of CAs over the study period, with a Mantel-Haenszel χ² of 82.76 (p=0.001). Factors associated with CA included maternal age over 35 years (adjusted OR (AOR)=1.68, 95% CI 1.07, 2.62), place of birth (AOR=2.04, 95% CI 1.04, 4.02) and normal birth weight (AOR=0.14, 95% CI 0.04, 0.47).

Conclusion: The data from the KHDSS revealed a rising trend in CAs. CA was associated with factors such as the mother's age, place of birth and the baby's birth weight. It is crucial for healthcare providers and stakeholders to consider these factors in efforts to reduce the prevalence of CAs.

Objectives: Given China's low fertility rate, assisted reproductive technology (ART) can be used assist infertile patients in having children. This study aimed to analyse patients' preferences for ART and to determine the relative importance (RI) and willingness to pay (WTP) of key attributes.

Design: We identified six attributes of ART and used a D-efficient design to generate choice sets for conducting a discrete choice experiment. Patients were asked to choose between two scenarios that differed in participation in treatment decision-making (TDM), clinical pregnancy rate, live birth rate, risk of maternal and neonatal complications, and out-of-pocket cost.

Setting: Jiangsu province, China. The anonymous survey was carried out between December 2022 and February 2023.

Participants: Female patients aged 20-45 years, with low fertility or experience of ART treatment. We recruited 465 participants.

Outcomes measures: Patient-reported preferences for each attribute were estimated using a mixed logit model. The latent class model was also used to investigate preference heterogeneity.

Results: All attributes were associated with patient preferences. Patients considered the live birth rate as the most important attribute (RI=29.05%), followed by participation in TDM (RI=21.91%). The latent class model revealed two distinct classes named 'outcome driven' and 'cost driven'. Preferences varied according to their age, monthly household income and location.

Conclusions: This study investigated the preferences of infertile patients when seeking medical assistance for infertility. The study outcomes can contribute to evidence-based counselling and shared decision-making and provide an empirical basis for creating and implementing future policies.

Introduction: Manual investigation of falls incidents for quality improvement is time-consuming for clinical staff. Routine care delivery generates a large volume of relevant data in disparate systems, yet these data are seldom integrated and transformed into real-time, actionable insights for frontline staff. This protocol describes the co-design and testing of a safe mobility and falls informatics platform for automated, real-time insights to support the learning response to inpatient falls.

Methods: Underpinned by the learning health system model and human-centred design principles, this mixed-methods study will involve (1) collaboration between healthcare professionals, patients, data scientists and researchers to co-design a safe mobility and falls informatics platform; (2) co-production of natural language processing pipelines and integration with a user interface for automated, near-real-time insights and (3) platform usability testing. Platform features (data taxonomy and insights display) will be co-designed during workshops with lay partners and clinical staff. The data to be included in the informatics platform will be curated from electronic health records and incident reports within an existing secure data environment, with appropriate data access approvals and controls. Exploratory analysis of a preliminary static dataset will examine the variety (structured/unstructured), veracity (accuracy/completeness) and value (clinical utility) of the data. Based on these initial insights and further consultation with lay partners and clinical staff, a final data extraction template will be agreed. Natural language processing pipelines will be co-produced, clinically validated and integrated with QlikView. Prototype testing will be underpinned by the Technology Acceptance Model, comprising a validated survey and think-aloud interviews to inform platform optimisation.

Ethics and dissemination: This study protocol was approved by the National Institute for Health Research Imperial Biomedical Research Centre Data Access and Prioritisation Committee (Database: iCARE-Research Data Environment; REC reference: 21/SW/0120). Our dissemination plan includes presenting our findings to the National Falls Prevention Coordination Group, publication in peer-reviewed journals, conference presentations and sharing findings with patient groups most affected by falls in hospital.

Objective: The primary study aims were to evaluate the implementation, mechanisms and context of a timely short-term specialised palliative care intervention for older people with frailty (Frailty+ intervention) as well as to assess the feasibility of a randomised controlled trial to evaluate Frailty+. Our secondary aim was to describe any preliminary effects of Frailty+.

Design: Pilot randomised controlled trial with process evaluation.

Setting/participants: We aimed to recruit 50 adults (≥70 years) with Clinical Frailty Scale score 5-7, and complex care needs and their main family carer, if available, from two Belgian hospitals on discharge.

Interventions: Patients were randomised to the Frailty+ intervention alongside standard care or standard care alone.

Outcome measures: Implementation and trial feasibility were assessed through interviews, focus groups and quantitative data. The primary outcome to be used in a potential full-scale trial if the study is feasible and implementable was mean change in five palliative care symptoms over 8 weeks.

Results: We enrolled 37 patients (19 intervention, 18 control) and 26 family carers (15 intervention, 11 control). Patients and family carers valued the home visits from palliative care nurses, and nurses saw value in Frailty+. But most patients received only one visit over 8 weeks, and nurses did not organise foreseen multidisciplinary meetings, referring to absence of urgent needs. Many aspects of the trial methods were feasible, but recruitment was challenging. The baseline mean score on the five palliative care symptoms was 6.0 and 5.6 in intervention and control group, respectively; and 4.5 and 4.1 at 8 weeks (adjusted ratio 1.0, ie, no effects on symptoms).

Conclusions: While Frailty+ was generally welcomed by older people with frailty, families and palliative care nurses, our process evaluation uncovered multiple barriers, mostly rooted in the current organisation of specialised palliative care that is tailored to advanced stages of illness. Ensuring timely access requires efforts beyond timely referral alone, and implies profound organisational and cultural change.

Trial registration number: ISRCTN39282347.

Introduction: Pregnant women and their babies are a highly vulnerable population to health effects from air pollution. This scoping review aims to understand the extent and type of evidence concerning the mediating and moderating factors between air pollution and birth outcomes. By gathering and synthesising this evidence, this review aims to identify key concepts, themes and knowledge gaps. In turn, these findings will serve as a valuable resource for researchers and policymakers by highlighting potential pathways and gaps in evidence.

Methods and analysis: This scoping review protocol is based on the Joanna Briggs Institute (JBI) methodology for scoping reviews and will be reported in full with a Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping review (PRISMA-ScR) flow diagram. This review will search eight databases: Web of Science, Scopus, PubMed, Embase, GreenFILE, CINAHL Ultimate, APA PsycINFO and MIDIRS. Results will be limited to those written or translated into English and peer-reviewed studies with no restriction on publication date. The study selection and data extraction will be completed within the software Covidence by two or more independent reviewers, with conflicts solved by group discussion. The data extracted from this process will include publication details, study characteristics and population characteristics.

Ethics and dissemination: This study will not collect primary data; therefore, no formal ethical approval is required. The findings will be disseminated to academic and non-academic audiences through conferences, publications and focus groups.

Trail registration number: Open Science Framework (https://doi.org/10.17605/OSF.IO/6Y2D9).

Introduction: In Swedish municipal elder care, there is a growing expectation that welfare technology (WT) will play a pivotal role in addressing the increasingly complex needs of older persons who receive municipal elder care. As the ageing population continues to rise, the strain on welfare resources both, human and financial, intensifies. The adoption of WT holds promise for enhancing the well-being of older persons, their significant others, organisations and caregiving staff. However, the perspectives of older persons, significant others, staff and decision-makers' on the aspects of security, activity, independence and participation that WT aims to influence needs further investigation. Thus, the overall purpose of the project is to explore how WT is perceived, implemented and experienced by different stakeholders within municipal elder care and to determine if, and how, WT contributes to the person's security, activity, participation and independence.

Methods and analysis: The project has a qualitative approach and will use thematic analysis. Data will be collected through semistructured interviews with different stakeholders-(a) older persons, (b) significant others, (c) staff and (d) decision-makers (ie, local politicians and local governmental officials)-in organisations within municipal elder care that use WT.

Ethics and dissemination: The study is approved by the Swedish Ethical Review Authority (Dnr 2023-07203-01). All participants will provide informed consent. Dissemination of the results will be achieved through scientific publications and presentations at national and international conferences. During manuscript preparation, the Standards for Reporting Qualitative Research will be followed. The knowledge gained from the project will be shared with participating organisations, where presentations and discussions regarding the project will be offered. Stakeholders and the public will also be offered opportunities to attend seminars and lectures provided by participating universities.

Background: The transition from traditional office work to telework has accelerated significantly since the late 20th century, especially in light of the COVID-19 pandemic. Despite its widespread adoption, the long-term health impacts of telework remain unclear. This study seeks to clarify the telework-health relationship by integrating longitudinal self-reported health data with health-related administrative records.

Methods and analysis: An online self-reported longitudinal survey with four follow-ups of 6 months each, starting in November 2024, will be set up and linked with administrative data sources. In total, a non-probabilistic sample of 5000 non-teleworkers and teleworkers will be recruited. This survey will mainly assess the effect of teleworking on mental (eg, depression and anxiety) and physical (eg, pain) health. Administrative data (eg, healthcare consumption contacts and socioeconomic status) will be extracted from Belgian administrative data sources (Statistics Belgium and the InterMutualistic Agency) for the same period. This administrative data will be linked to the survey data using the Social Security ID. The underlying relationships between telework and health will be analysed via regression models and mediation models embedded in the natural effects framework. The analysis will aim to (1) identify the impact of telework on self-reported health and administrative data, (2) identify the moderators and mediators between the telework-health relationship, (3) understand the long-term patterns of telework and health interaction and (4) predict the health outcomes of teleworkers. To mitigate biases associated with non-probabilistic samples and attrition, standardised probability weights scoring will be derived from the data.

Ethics and dissemination: This study involves human participants and has been approved by the Ethics Committee of Universitair Ziekenhuis Gent (Nr°. ONZ-2023-0630). The participants will participate in the study after signing an informed consent form. The study will be disseminated in academic journals, on (social) media and on the project website.

Introduction: As a result of improving survival rates, the adverse consequences of rectal cancer surgery are becoming increasingly recognised. Low anterior resection syndrome (LARS) is one such consequence and describes a constellation of bowel symptoms after rectal cancer surgery which includes urgency, faecal incontinence, stool clustering and incomplete evacuation. LARS has a significant adverse impact on quality of life (QoL) and symptoms are present in up to 75% of patients in the first year after surgery. Despite this, little is known about the natural history and there is poor evidence to support current treatment options.

Methods and analysis: The objectives of POLARiS are to explore the natural history of LARS and to evaluate the clinical and cost-effectiveness of transanal irrigation (TAI) or sacral neuromodulation (SNM) compared with optimised conservative management (OCM) for people with major LARS.POLARiS is a prospective, international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort design, with internal pilot phase, qualitative sub-study, process evaluation and economic evaluation. Approximately 1500 adult participants from UK hospitals and 500 from Australian hospitals who have undergone a high or low anterior resection for colorectal cancer in the last 10 years will be recruited into the cohort. Six-hundred participants from the UK and 200 participants from Australia, with major LARS symptoms, defined as a LARS score of ≥30, will be recruited to the randomised controlled trial (RCT) element. Participants entering the RCT will be randomised between OCM, TAI or SNM, all with equal allocation ratios.Cohort and RCT participants will be followed up for a 24-month period, completing a series of questionnaires measuring LARS symptoms and QoL, as well as clinical review for those in the RCT. A process evaluation, qualitative sub-study and economic evaluation will also be conducted.The primary outcome measure of the POLARiS cohort and RCT is the LARS score up to 24 months post-registration/randomisation. Analyses of the RCT will be conducted on an intention-to-treat basis. Comparative effectiveness analyses for each endpoint will consist of two pairwise treatment comparisons: TAI versus OCM and SNM versus OCM. Secondary outcomes include health-related QoL, adverse events, treatment compliance and cost-effectiveness (up to 24 months post-registration/randomisation).

Ethics and dissemination: Ethical approval has been granted by Wales REC 4 (reference: 23/WA/0171) in the UK and Sydney Local Health District HREC (reference: 2023/ETH00749) in Australia. The results of this trial will be disseminated to participants on request and published on completion of the trial in a peer-reviewed journal and at international conferences.

Trial registration number: ISRCTN12834598; ACTRN12623001166662.