BMJ Open最新文献

Introduction: The number of people living with obesity is increasing rapidly worldwide, and the WHO estimates approximately 5 million deaths yearly from non-communicable diseases related to elevated body mass index (BMI). The most effective treatment for weight loss is bariatric surgery, but due to the associated risks and the need for lifelong care, this is not a viable treatment for every patient. With the advent of gut-hormone-based medications to treat obesity, the effectiveness of non-surgical treatment is approaching that of surgical interventions. We therefore aim to investigate the beneficial and harmful effects of laparoscopic bariatric surgery versus any non-surgical treatment.

Methods and analysis: We will conduct a systematic review with meta-analysis applying our eight-step procedure to assess thresholds for clinical significance and trial sequential analysis to mitigate the risk of random errors. To identify relevant trials, we will search for both published and unpublished trials, without any language restriction, in major medical databases (CENTRAL, MEDLINE, EMBASE, LILACS, SCI-EXPANDED and CPCI-S) and trial registries. The date range covered by the search is from database inception until final search date-within 3 months prior to submission of final results manuscript. Two review authors will independently screen references, extract data and perform risk-of-bias assessment using the Cochrane Risk of Bias Tool 2 and the Grading of Recommendations, Assessment, Development and Evaluations. We will include randomised clinical trials comparing laparoscopic surgery currently in use with any non-surgical comparator in adults or adolescents with BMI >30 kg/m². Quasi-randomised studies or non-randomised studies will not be included. Our critical outcomes are all-cause mortality, serious adverse events and quality of life, and our important outcomes are major cardiovascular events, weight at follow-up, physical function and glycaemic control. In addition, we have two explorative outcomes: metabolic syndrome or Z-score and reported incident of alcohol abuse or other addictive disorder or self-inflicted harm.

Ethics and dissemination: This review will collect and perform secondary analysis of data from publicly available sources and ethical approval is therefore not required. The findings will be published in peer-reviewed journals and presented at relevant scientific conferences. We will strive to publish with open access. Awareness will be made through social media platforms. This review aims to help clinicians in identifying best practices in the wide-spanning field of obesity treatment.

Prospero registration number: CRD420251135341.

Background: Adolescents placed in state-run secure youth homes (by the Swedish National Board of Institutional Care) due to substance misuse and serious norm-violating behaviour (including offending) are in pressing need of effective help, yet available treatments lack scientific support. The treatment Adolescent Community Reinforcement Approach (A-CRA) supports abstinence and improves social functioning in outpatient settings, but has not been evaluated in secure youth homes.

Objective: To evaluate the feasibility, acceptability and preliminary effects of A-CRA in Swedish secure youth homes, and assess the feasibility of study procedures before a multicentre randomised controlled trial (RCT).

Methods: In a randomised feasibility trial, 42 adolescents (16-20 years) at four secure youth homes were allocated to A-CRA plus treatment as usual (A-CRA+TAU; n=22) or TAU alone (n=20). Substance use was measured with self-reports and registry data at baseline, post-treatment and up to 24 months after treatment; participants were also interviewed about acceptability and satisfaction.

Results: Feasibility was demonstrated: 77% reached the predefined exposure threshold (≥12 A-CRA procedures). Adolescents found the intervention acceptable and helpful in secure care. Study procedures were largely workable, though questionnaire data showed substantial missingness. Preliminary effects were favourable, with no evidence of harm.

Conclusions: A-CRA appears feasible in secure youth care, with minor adjustments, and is perceived as helpful and acceptable by adolescents. Treatment effects will be evaluated in an upcoming multicentre RCT.

Trial registration number: NCT05081934.

Introduction: Dementia contributes to the disease burden worldwide, and people with hypertension or type 2 diabetes are at an elevated risk of developing dementia. It is essential to prevent or delay cognitive decline in people at high risk within the community. Our trials aim to evaluate the effects of adaptive cognitive training on community-dwelling older adults with hypertension or type 2 diabetes but no dementia.

Method and analysis: Two multicentre, double-blind, randomised, placebo-controlled trials, named COgNitive Training in community-dwelling older adults at high risk for demENTia and with Hypertension (CONTENT-Hypertension) and COgNitive Training in community-dwelling older adults at high risk for demENTia and with Diabetes (CONTENT-Diabetes), will be conducted to investigate the effects of adaptive cognitive training on participants aged 60 years or above who have been diagnosed with hypertension or type 2 diabetes but no dementia. Each trial will enrol 120 participants. Participants will be recruited from the local community in Shijingshan and Haidian Districts, Beijing, and allocated to either the intervention or control group using a 1:1 ratio. The intervention group will engage in 12 weeks of adaptive cognitive training, while the control group will receive 12 weeks of placebo cognitive training. A 24-week follow-up assessment will be conducted for all participants to evaluate the persistence of the effects. The primary outcome is the 12-week change in Montreal Cognitive Assessment (MoCA) Basic scores from baseline to the end of the intervention (12 weeks). Secondary outcomes include 6-week and 24-week changes in the MoCA from baseline; 6-week, 12-week and 24-week changes in Trail Making Test-A&B (TMT-A, TMT-B), Digit Symbol Substitution Test, the WHO/University of California at Los Angeles Auditory Verbal Learning Test and Boston Naming Test scores of cognitive functions; 6-week and 12-week changes in Geriatric Depression Scale, Generalised Anxiety Disorder-7 (GAD-7), Pittsburgh Sleep Quality Index and 12-week change in blood pressure (CONTENT-Hypertension) or fasting blood glucose and glycated haemoglobin (CONTENT-Diabetes) from baseline.

Ethics and dissemination: This study will adhere to the ethical principles outlined in the Declaration of Helsinki and comply with international standards for Good Clinical Practice. All participants will sign the informed consent at baseline. This study has been approved by the Ethics Committee of Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (approval numbers: 2023-139 and 2024-162). The findings of the trials will be disseminated through publications in peer-reviewed scientific journals and presented at academic conferences.

Trial registration numbers: NCT06512922 and NCT06524388.

Objectives: This study aimed to investigate the longitudinal association between sleep disturbance and the risk of new-onset incontinence in middle-aged and older Chinese adults and to explore whether chronic lung diseases mediate this relationship.

Design: A prospective cohort study based on a nationally representative survey.

Setting: Data were obtained from the China Health and Retirement Longitudinal Study, a national survey of middle-aged and elderly community-dwelling Chinese adults.

Participants: A total of 7098 participants aged ≥50 years who were continent at baseline in 2011 and completed follow-up in 2015 were included in the analysis.

Measures: Sleep disturbance was assessed via self-report and categorised into good versus poor quality. Incident incontinence was defined as a new onset of difficulty in controlling urination or defecation. Multivariable logistic regression models were used to estimate the association between baseline sleep disturbance and incident incontinence, adjusting for sociodemographic, behavioural and health-related covariates. Mediation analysis was conducted to evaluate the indirect role of chronic lung disease in the sleep-incontinence pathway. Subgroup and interaction analyses assessed whether key demographic or health factors influenced the sleep-incontinence association.

Results: Sleep disturbance at baseline was significantly associated with a higher risk of developing incontinence over 4 years (adjusted OR 1.34, p=0.040). This association remained robust across subgroups, particularly among participants aged ≥65 years, rural residents, those with higher education and those with chronic lung disease. Mediation analysis revealed that chronic lung disease partially mediated the relationship between sleep disturbance and incontinence, accounting for 7.59% of the total effect (indirect effect: 0.00104, 95% CI 0.00012 to 0.00170). Subgroup and interaction analyses confirmed the consistency of the findings across various demographic and health strata.

Conclusion: Sleep disturbance was associated with higher odds of incident incontinence among middle-aged and older Chinese adults. Chronic lung disease contributed modestly to this association. These findings underscore the potential importance of sleep health and comorbidity management in continence care for ageing populations.

Introduction: Chemotherapy-induced nausea and vomiting (CINV) is a common symptom in cancer, and it is one of the distressing symptoms in patients with cancer receiving chemotherapy. Information about side effects may exacerbate CINV due to the nocebo effect. This study aims to examine the efficacy of pharmacist-led enhanced support for coping with side effects during medication counselling, which includes providing information about side effects, with the goal of mitigating the nocebo effect and reducing CINV.

Methods and analysis: This multicentre exploratory open-label randomised controlled trial will examine the efficacy of pharmacist-led enhanced support for coping with the side effects of treatments during medication counselling in patients with advanced lung cancer. The control group will receive medication counselling as usual. The study population will consist of patients with advanced lung cancer who have not received chemotherapy and are receiving highly emetogenic chemotherapy or equivalent chemotherapy. The primary endpoint is the prevention of nausea, and the secondary endpoints include complete response (no vomiting event and no rescue medication), stress (objectively assessed using the salivary cortisol and immunoglobulin A), coping strategies and quality of life.

Ethics and dissemination: This study received approval from the medical ethics committee of Kansai Medical University. The results will be submitted for publication in an international peer-reviewed journal, and the findings will be presented at international scientific conferences.

Protocol version: 1.0, 18 Mar 2025 TRIAL REGISTRATION NUMBER: Registration number: UMIN000056068.

Introduction: Suicidal thoughts and behaviours (STB) are a critical public health concern, with 700 000 deaths by suicide each year. The period immediately following hospital discharge is associated with an elevated risk for suicide. Monitoring suicidal ideations throughout this period is therefore critical. However, its highly dynamic nature limits the utility of traditional risk assessments through infrequent outpatient visits. Recent advancements in ambulatory assessments and multimodal predictive approaches offer a promising new avenue. Hence, the present study aims to examine how psychological, linguistic, neurobiological and smartphone-based characteristics relate to suicidal ideation and to improve STB monitoring through a deep phenotyping approach.

Methods and analysis: In this interdisciplinary, multicentre, prospective observational study, we plan to recruit a total of 200 inpatients with current and/or past STB. The study comprises the following components: (1) a baseline assessment, conducted while participants are still in the hospital. This includes interviews, an electroencephalography recording, a video-recorded verbal task and self-report questionnaires; (2) data collection through a smartphone application during the first 4 weeks after hospital discharge with two active collection weeks of five daily ecological momentary assessments and two 1 min video diaries every other day, as well as smartphone passive sensing for 28 consecutive days and (3) two follow-up assessments, 4 weeks and 3 months after discharge. The primary outcome is self-reported suicidal ideation after hospital discharge.

Ethics and dissemination: The Ethics Committee of the Faculty of Arts and Social Sciences of the University of Zurich, Switzerland, approved the study for the Zurich and Basel sites (Ref: 22.09.19). Approval for the New York Site was granted by the Institutional Review Board of NYU Langone Health (i23-00366). Study findings will be disseminated via peer-reviewed, open-access publications, conference presentations, patient and public events, and dedicated social media outlets.

Trial registration number: CRSII5_205913.

Introduction: With the increasing frequency and intensity of disasters globally-and their profound effects on the mental well-being of healthcare professionals, particularly nurses-the psychological distress experienced by nurses following natural disasters has become a pressing issue. This study aims to explore prevalent patterns and effective interventions for supporting nurses' psychological recovery after disaster exposure, ultimately aiming to propose an optimal recovery model.

Methods and analysis: This systematic review will include qualitative, quantitative and mixed-methods studies, as well as relevant systematic reviews, published in English between 2010 and 2025. A comprehensive search will be conducted in PubMed, Web of Science, Scopus and Google Scholar. Study selection, data extraction and quality assessment will be performed independently by multiple reviewers, with methodological quality and risk of bias evaluated using the Mixed Methods Appraisal Tool. Due to anticipated heterogeneity, findings will be synthesised using thematic analysis.

Ethics and dissemination: This study protocol raises no ethical issues. The results will be shared through publication in peer-reviewed journals and presentations at appropriate academic conferences.

Prospero registration number: CRD420251014914.

Objectives: To explore how people perceive different forms of education for rotator cuff-related shoulder pain in terms of words or feelings evoked by the education and treatments they feel are needed.

Setting: We performed a content analysis of qualitative data collected in a randomised experiment.

Participants: 2237 participants with rotator cuff-related shoulder pain were randomly assigned to receive three forms of education: best practice education, best practice education plus pain science messages and structure-focused education.

Primary and secondary outcomes: After receiving the education, participants answered two questions regarding (1) words or feelings evoked by the education and (2) treatments they felt were needed.

Results: 2232 responses for each question were analysed (99.7% response rate). Participants who received best practice education more frequently expressed feelings of unhappiness/frustration. The addition of pain science messages to best practice education resulted in slightly more emotional responses and a greater sense of being validated or cared for. In contrast, participants who received structure-focused education more frequently expressed trust in the clinician's expertise and the need for medication, activity modification, rest, diagnostic imaging, injections and surgery. These participants also less frequently considered exercise as a viable treatment option.

Conclusion: Participants with rotator cuff-related shoulder pain expressed generally similar emotional responses across groups, with small differences in treatment preferences favouring self-management in the best practice education groups compared with those who received structure-focused education. Those in the best practice education also less frequently reported needing potentially unnecessary treatments (eg, imaging, injections and surgery).

Trial registration number: Australia New Zealand Clinical Trials Registry (ACTRN12623000197639).

Objectives: To qualitatively explore the lived experiences and perceptions of patients with chronic obstructive pulmonary disease (COPD) using the harmonica as a therapeutic intervention.

Design: A qualitative study.

Setting: The study was conducted at a tertiary hospital in Guangzhou, China.

Participants: Patients with COPD who had participated in supervised harmonica playing for at least 12 weeks. (clinical trial registration: NCT05995847).

Primary and secondary outcome measures: The study focused on patients' experiences, including perceived facilitators, barriers and needs regarding the intervention.

Results: We interviewed 19 patients with COPD between September and December 2024, with interviews lasting an average of 54 min (range: 36-77 min). Five primary themes were identified. Participants reported better physical functioning, including better breathing control, enhanced functional capacity and improved sleep quality. Psychological well-being improved with increased relaxation, emotional improvement and mental engagement. Patients also experienced increased social engagement and role shift, such as expanded social connections, family support and restored family roles. Harmonica playing promoted enhanced self-reliance and personal development, with increased self-management confidence, mastery of the harmonica and encouragement for lifelong learning. Barriers and challenges included physical limitations, breathing difficulties, adherence issues and concerns about the sustainability of long-term benefits.

Conclusions: Our study indicates that harmonica playing could improve physical health, psychological well-being, social participation and self-reliance, although barriers persist. Tailored programmes could enhance benefits and adherence, and future research should evaluate durability within comprehensive COPD care.

Trial registration number: NCT05995847.