BMJ Open最新文献

Objective: To examine inpatient benzodiazepine receptor agonists prescribing patterns and assess how hospitalisation affects use at discharge.

Design: Subanalysis of the WEsleep trial, a cluster-randomised controlled single-centre study conducted at Amsterdam University Medical Center (Amsterdam UMC) (two locations) between July 2023 and March 2024. Twelve departments (six medical, six surgical) were matched and randomised to intervention or standard care. On intervention wards, multiple measures to improve sleep were implemented, including minimising nighttime disruptions.

Setting: Amsterdam UMC, across medical and surgical hospital departments.

Patients: Adult patients admitted for ≥2 nights (medical) or undergoing elective non-cardiac surgery in a surgical department.

Primary and secondary outcome measures: Benzodiazepine use was classified as no use, pre-admission use or new in-hospital initiation. Prescribing patterns were summarised descriptively according to type, timing, indication and discharge status.

Results: Of 746 patients, 187 (25%) used benzodiazepines: 80 (43%) had pre-admission use, and 107 (57%) were newly initiated during their hospital stay. Among pre-admission users, two discontinued and five had adjustments at discharge. Among newly initiated users, 94 (88%) had their benzodiazepine discontinued at discharge. Approximately half of pre-admission prescriptions and one-third of in-hospital prescriptions lacked a documented indication.

Conclusions: Although most newly initiated benzodiazepine treatments were discontinued during hospitalisation, pre-existing use was rarely reassessed and nearly 10% of new users were discharged with a prescription. Structured deprescribing protocols, better documentation of indications and improved discharge planning are needed to promote safer and more rational benzodiazepine use.

Trial registration number: NCT05683483.

Introduction: Glaucoma is one of the leading causes of irreversible blindness and is characterised by progressive loss of retinal ganglion cells. While therapies to lower intraocular pressure slow the progression of the disease in most patients, a significant subset still shows progression despite treatment. Transcorneal electrical stimulation (TES) may potentially activate neuroprotective pathways and slow the progression of visual field defects. The OkuStim 2 System is a medical device for TES which was originally developed for the treatment of retinitis pigmentosa and similar retinal dystrophies and shall now be tested for the treatment of glaucoma. Stimulation of the diseased retina with weak currents can activate signalling pathways and the release of substances that have a protective effect on the retinal cells. This neuroprotective effect might preserve physiological functions of the retina for longer and slow down its gradual degeneration. Long-term use is required to maintain this effect. The TES-GPS study is investigating the safety and efficacy of TES in open-angle glaucoma.

Methods and analysis: TES-GPS (short title for glaucoma pilot study) is a prospective, randomised, double-blind, sham-controlled, single-centre pilot study at the University Medical Center Mainz. 50 patients with progressive visual field loss due to open-angle glaucoma will be randomised 1:1 to receive either TES with the OkuStim 2 System or sham stimulation. The primary endpoint is the change in visual field sensitivity (Humphrey mean deviation) after 18 months. Secondary endpoints include changes in visual acuity, intraocular pressure, optical coherence tomography (OCT) parameters and quality of life (National Eye Institute Visual Function Questionnaire 25, NEI-VFQ 25). The intervention consists of weekly 30 min TES sessions, which are conducted in the patient's home after initial training in the clinic. The study comprises up to 13 scheduled visits over 18 months.

Ethics and dissemination: The study is conducted in accordance with ISO14155, Medical Device Regulation (EU) 2017/745, International Council for Harmonisation Good Clinical Practice and the Declaration of Helsinki. Approval was obtained from the Ethics Committee of the Landesaerztekammer Rheinland-Pfalz in Mainz and from Bundesinstitut fuer Arzneimittel und Medizinprodukte. Results will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number: NCT06682962.

Introduction: Increased risks and concerns regarding patient safety in early-phase studies exist because knowledge about the new intervention is still accumulating. This means that narrow eligibility criteria are needed. However, if early-phase studies are narrow in their inclusion, for example, by not including diverse populations, there is a potential risk that new therapies have insufficient relevant efficacy and safety data. Existing research has explored equity, diversity and inclusion (EDI) factors in early-phase pharmaceutical studies, but it has not been possible to find studies that have systematically examined whether EDI factors have been considered in surgical studies reporting innovative procedures. We aim to examine how EDI factors are considered in early-phase surgical studies and surgical innovation reports to explore how this may impact on later-phase evaluation and inclusive intervention implementation.

Methods and analysis: A scoping review following the JBI (Joanna Briggs Institute) and Arksey and O'Malley's five-step process is being conducted. We will search Scopus, PubMed and Web of Science for surgical early-phase studies. A two-step screening process for eligibility is being used. Independent double screening will take place for 20% of the papers. Eligible articles will report early evaluation of an innovative surgical/invasive procedure. Excluded will be comparative and later-phase studies and early evaluations of pharmaceutical products even in a surgical setting. Data on article details, patient eligibility and whether protected characteristics are reported and considered will be extracted. Information about EDI considerations reported in the introduction or discussion of the papers will also be extracted. Findings will be discussed with a patient advisory group. A content synthesis approach will be undertaken and descriptive summaries presented.

Ethics and dissemination: This study does not require ethical approval being a secondary analysis. The findings will be disseminated through academic journal publications and oral presentations.

Introduction: Despite international efforts to address women's long-term health and well-being, significant gaps in sexual and reproductive health (SRH) services and non-communicable diseases (NCDs) prevention remain, particularly in low-and-middle-income countries (LMICs).

Methods: We analysed data from 726 278 women aged 15-49 from six national surveys (2017-2021, Benin, Cameroon, Gabon, India, Madagascar and Mauritania) on unmet needs for NCD prevention (blood pressure, glucose, cervical cancer screening) and SRH services (contraception, antenatal, postnatal care). Unmet needs prevalence was calculated as the percentage of participants with specific unmet needs and estimated across demographics and socioeconomic groups using multivariable logistic regression models.

Results: Unmet needs were strikingly high for NCD prevention: 36.6% for blood pressure, 70.0% for blood glucose and 98.5% for cervical cancer screening. In contrast, unmet needs for contraception, antenatal care and postnatal care were relatively lower: 7.5%, 14.5% and 14.5%, respectively. Significant variations were observed across countries. India had the lowest unmet needs for SRH services: 6.7% for contraception, 13.1% for antenatal care and 13.1% for postnatal care. Gabon had lower unmet needs for prenatal (16.8%) and postnatal care (14.8%) compared with other African countries and the lowest unmet need for cervical screening at 84.7% (95% confidential interval 83.1% to 86.2%), over 10 percentage points lower than others. Furthermore, socioeconomic factors like higher education, better economic status, healthcare access, insurance and internet use significantly lowered unmet needs, especially for antenatal and postnatal care. Employed women had higher unmet needs for antenatal (35.7%) and postnatal (37.3%) care than unemployed women (28.1%, 27.8%) but lower for NCDs prevention (98.9%, 71.8%) under two definitions than unemployed women (99.3%, 79.2%).

Conclusion: This study highlights the urgent need to address high unmet needs for NCD prevention among women in LMICs, particularly cervical cancer screening. Unmet SRH needs are also a major concern, given significant disparities across countries. Especially, governments should prioritise measures to focus on vulnerable groups.

Introduction: Malaria remains a major public health challenge in India, with transmission dynamics varying widely across ecological, epidemiological, sociobehavioural and health system contexts. Achieving the national malaria elimination target by 2030 requires integrated, context-specific evidence to design effective interventions. This study aims to generate a comprehensive understanding of malaria transmission and factors surrounding it across diverse eco-epidemiological settings in India by assessing malaria burden, identifying determinants of transmission, evaluating health system performance and equity, characterising vector bionomics and insecticide resistance, and examining the influence of environmental drivers.

Methods and analysis: This longitudinal, multicentric study will be conducted in collaboration with the national programme in 12 districts spanning 10 states in India, covering a population of around 25 000 individuals representing varied ecological contexts (urban, periurban, rural, forest-foothill and coastal) and malaria endemicity levels. In each district, two clusters (villages) with a population of 1000 individuals will be included. A baseline mass survey will estimate malaria prevalence using bivalent rapid diagnostic tests (RDTs) and blood smear microscopy, with low-density parasitaemia detected by PCR in a subset of RDT-negative samples. Participants will be followed for 1 year, with monthly screening of symptomatic individuals using RDT and microscopy, and testing a subset of asymptomatic individuals to detect subclinical infections. Sociobehavioural data will be collected through structured interviews and household observations, with purposive inclusion of vulnerable groups, pregnant women, migrants, elderly persons, individuals with disabilities and tribal populations to assess equity dimensions through mixed-methods approaches. Health system performance will be evaluated through key informant interviews with programme officials, health workers, patients, private practitioners and traditional healers. Entomological surveillance will document vector species composition, density, infection rates and assessment of susceptibility status and intensity of insecticide resistance to commonly used public health insecticides. Environmental variables, including temperature, rainfall and humidity, will be linked with entomological and epidemiological data to explore spatiotemporal relationships.

Ethics and dissemination: The protocol was approved by the Institute Human Ethics Committee of ICMR-Vector Control Research Centre (IHEC 03-0125/N/F). All standard ethical practices will be adhered to. The findings will be shared with stakeholders and published in reputed open-access journals.

Introduction: The surge in postsecondary students reporting mental health concerns, coupled with increased utilisation of on-campus and hospital-based mental healthcare, highlights a need to understand effective service navigation. To address this system gap, the University of Toronto and the Centre for Addiction and Mental Health (CAMH) leveraged their unique expertise and resources to develop the University of Toronto Navigation (UTN) service. UTN introduces care navigators to facilitate postsecondary student transitions from acute mental health services to community or campus mental healthcare. There has been limited implementation and evaluation of navigator models specific to the postsecondary context to date, which hinders scalability. This paper describes the study protocol of Navigation to Enhance Post-Secondary Students' Acute Mental Health Care Transitions, a study that aims to collaborate with students, navigators and clinicians to evaluate the UTN service.

Methods and analysis: A one-stage, single-arm multimethods study design will be used to evaluate the UTN service. We will recruit 103 students following their UTN intake appointment. Students will complete quantitative measures assessing health outcomes, experiences of care and service utilisation at baseline and at three subsequent time points across a 6-month follow-up period. The quantitative data will be linked to administrative healthcare data. The primary evaluation outcome will be defined as attending an appointment with an appropriate care provider (in person or virtually) within 30 days of discharge from the hospital. We will conduct interviews with students and referring clinicians to gather perspectives regarding their experiences and satisfaction with the UTN service in greater depth.

Ethics and dissemination: Research ethics board approvals have been obtained from the University of Toronto and CAMH. Results will be disseminated through publications and presentations, and a toolkit will be cocreated to support implementation and adaptation of hospital-based navigator interventions in postsecondary contexts.

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: 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.

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.