BMJ Open最新文献

{"title":"Somatic acupressure for the management of the fatigue-sleep disturbance-depression symptom cluster in breast cancer survivors: a study protocol for a phase III randomised controlled trial.","authors":"Mengyuan Li, Tao Wang, Xian-Liang Liu, Ren-Li Deng, Wai Hang Kwok, Li-Qun Yao, Jing-Yu Benjamin Tan","doi":"10.1136/bmjopen-2024-089515","DOIUrl":"10.1136/bmjopen-2024-089515","url":null,"abstract":"<p><strong>Introduction: </strong>The fatigue-sleep disturbance-depression symptom cluster (FSDSC) is commonly experienced by breast cancer (BC) survivors, leading to a deteriorated quality of life (QoL). Somatic acupressure (SA) has been recommended as a promising non-pharmacological intervention for cancer-related fatigue (the core symptom of the FSDSC) in the guidelines, showing its encouraging role in relieving cancer-related sleep disorders, fatigue and depression. This phase III randomised controlled trial (RCT) is designed to evaluate the effects, safety and cost-effectiveness of SA for managing the FSDSC in BC survivors.</p><p><strong>Methods: </strong>This phase III RCT will be a partial-blinded, sham-controlled, three-arm, parallel clinical trial, involving a 7-week SA intervention period and a 12-week follow-up period. 108 BC survivors will be randomly allocated in a ratio of 1:1:1 to either a true SA group (self-administered acupressure plus usual care), a sham SA group (self-administered light acupressure at non-acupoints plus usual care) or a usual care group. The primary outcomes will be the effectiveness of SA on the FSDSC at both the individual symptom level and cluster symptom level. Each individual symptom will be specifically measured by the Brief Fatigue Inventory (fatigue), the Pittsburgh Sleep Quality Index (sleep disturbance) and the Hospital Anxiety and Depression Scale-Depression (depression). The cluster symptom level will be measured by using an FSDSC composite score, an averaging score of three separated 0-10 numeric rating scales for fatigue, depression and sleep disturbance. The secondary outcomes will include QoL (measured by the Functional Assessment of Cancer Therapy-Breast), adverse events and cost-effectiveness. Outcomes will be assessed at baseline (week 0), immediately after intervention (week 7) and follow-up (week 19). All outcomes will be analysed based on the intention-to-treat principle using the Statistical Package for Social Science (SPSS 25) software.</p><p><strong>Ethics and dissemination: </strong>Ethical approvals of this study have been granted by the Human Research Ethics Committee at Charles Darwin University (H22110) and the Clinical Trial Ethics Committee at the Affiliated Hospital of Zunyi Medical University (KLL-2023-594), and the Second Affiliated Hospital of Zunyi Medical University (KYLL-2023-058). Findings from this trial will be published in peer-reviewed journals and presented at professional conferences.</p><p><strong>Trial registration number: </strong>NCT06412107.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e089515"},"PeriodicalIF":2.4,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11877206/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Unravelling the trajectory of frailty and its influencing factors in elderly patients with coronary heart disease after percutaneous coronary intervention: protocol for a cohort study in China.","authors":"Ya Yu, Cuirong Zhang, Yang Dong, Hongying Rao","doi":"10.1136/bmjopen-2024-089528","DOIUrl":"10.1136/bmjopen-2024-089528","url":null,"abstract":"<p><strong>Introduction: </strong>Frailty is an important factor affecting the short-term and long-term outcomes of elderly patients with coronary heart disease (CHD) after surgery. Most previous studies only assessed frailty before surgery or at discharge, and there was limited tracking of the occurrence and progression of frailty during hospitalisation and after surgery. This paper describes the trends and influencing factors of frailty in elderly patients with CHD before and 6 months after percutaneous coronary intervention (PCI).</p><p><strong>Method and analysis: </strong>The frailty study is an observational, prospective cohort study aiming to recruit patients with CHD over 60 years of age who intend to undergo PCI. This study aims to investigate the evolving trends in frailty among elderly patients who have undergone PCI in the 6 months following hospital discharge. Additionally, the influence of cognitive, behavioural, psychosocial, physiological and biological factors on the trajectory of frailty changes in this population was explored based on the International Classification of Functioning, Disability and Health. There will be 11 data collection points, within 48 hours after admission, at hospital discharge and then monthly for the first 6 months, followed by assessments at 12, 24 and 36 months postdischarge. A general estimation equation will be used to analyse the overall trend of frailty. Growth mixture modelling and latent class growth modelling will both be used to identify distinct frailty trajectories. Univariate and logistic regression analyses will be used to identify predictors of trajectories. The Cox proportional hazard regression model will be employed to explore the relationship between the changing trend of different types of frailty within 6 months after discharge and survival status at 36 months.</p><p><strong>Ethics and dissemination: </strong>Ethical approval has been obtained from the Ethics Committee of Guangzhou First People's Hospital (K-2023-136-01). All findings will be disseminated through publication in peer-reviewed scientific journals and presentation at conferences and stakeholder organisation events.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e089528"},"PeriodicalIF":2.4,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11877232/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of family-oriented gamification on self-management of people with multiple sclerosis: a mixed-methods study protocol.","authors":"Leily Zare, Nahid Dehghan Nayeri, Fatemeh Bahramnezhad, Arezoo Rasti","doi":"10.1136/bmjopen-2024-093232","DOIUrl":"10.1136/bmjopen-2024-093232","url":null,"abstract":"<p><strong>Introduction: </strong>Multiple sclerosis (MS) is a chronic disease of the central nervous system that impacts millions worldwide, including individuals in Iran. It primarily affects young people, leading to biopsychosocial challenges with unpredictable symptoms. Self-management is crucial but challenging due to the lack of definitive treatment. New approaches, such as mHealth interventions, particularly gamification, aim to engage patients more effectively. Well-designed gamification may positively impact health behaviours and enhance collaborative care. However, its implementation in the field of MS in Iran is currently limited. So far, some mobile applications have been designed that do not incorporate gamification principles and only focus on one issue. These applications also fail to consider the family caregivers' understanding of the patient's condition. Therefore, this study aims to investigate the impact of family-oriented gamification on the self-management of Iranian patients with MS.</p><p><strong>Methods and analysis: </strong>We propose a mixed-methods study with an exploratory sequential design consisting of a qualitative phase, gamification development and a dual-centre, prospective, single-blinded, parallel-group randomised controlled superiority trial. In the qualitative phase, data will be collected through purposive sampling via semistructured interviews with patients until data saturation is reached. Concurrently, the data will be analysed using conventional content analysis to provide insights into the patients' self-management challenges. Next, web-based and card gamification will be developed for patients and their families based on the findings of the qualitative phase. Ultimately, the effectiveness of these interventions will be evaluated through a randomised controlled trial. The preliminary literature suggests an initial sample size of 25-30 participants per group for this phase. After enrolling approximately 10 participants, the exact sample size will be recalibrated using G-Power software based on data analysis. Participants will then be randomly assigned to either the intervention or control group in a 1:1 ratio. Allocation concealment will be ensured using mixed block sizes of 2 and 4. The primary outcome, self-management, and the secondary outcome, self-efficacy, will be assessed both before and immediately after the intervention. Furthermore, the usability of the two gamification strategies will be evaluated following the intervention.</p><p><strong>Ethics and dissemination: </strong>This study is part of a doctoral thesis approved by the Tehran University of Medical Sciences Research Ethics Board (IR.TUMS.FNM.REC.1401.185, 23 February 2023). Dissemination of findings will occur at the local, national and international levels.</p><p><strong>Trial registration number: </strong>IRCT20240116060708N1.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e093232"},"PeriodicalIF":2.4,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Anchored in the eye of the storm: a qualitative study of resilient performance during the COVID-19 pandemic in Sweden in the context of the emergency department.","authors":"Ann-Sofie Källberg, Camilla Göras, Lena Berg, Petronella Bjurling-Sjöberg","doi":"10.1136/bmjopen-2024-094591","DOIUrl":"10.1136/bmjopen-2024-094591","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to explore how emergency department (ED) organisations and clinicians adapted to altered prerequisites during the first wave of the COVID-19 pandemic, the processes involved and the consequences. In addition, we examined how the ordinary state affected resilient performance during this period.</p><p><strong>Design: </strong>This qualitative study involved inductive thematic analysis of semi-structured interviews and narratives.</p><p><strong>Setting: </strong>Three hospital-based EDs, one county and two rural hospitals, located in two Swedish regions were studied.</p><p><strong>Participants: </strong>A total of 12 participants, 80% of whom were women, were recruited. The participants included two physicians, three registered nurses, three assistant nurses and four nursing managers working at the three EDs before and during the first pandemic wave.</p><p><strong>Results: </strong>The overarching theme 'anchored in the eye of the storm' emerged. This theme suggests that resilient performance during the pandemic was facilitated by ordinary adaptive capacity in the ED. A thematic map and seven main themes with a total of 25 subthemes explain the process. The ordinary state of conditions in the ED was challenged with the emergence of the COVID-19 pandemic. Altered prerequisites were perceived partly as a new reality in addition to business as usual. The adaptations included organise to regain control and developing new strategies to manage the situation, mainly by initiatives among clinicians. The consequences included perceived strain and frustration and partially impacted quality of care. However, an increased sense of cohesion among clinicians and enhanced knowledge were also noted.</p><p><strong>Conclusion: </strong>During the pandemic, a partially new reality was experienced, although work also continued largely as business as usual based on experiences of crowding, established preparedness plans and ordinary adaptive capacity. Despite dealing with a previously unknown patient group, the experience of working with critically ill patients and establishing structured work processes proved advantageous and facilitated resilient performance.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e094591"},"PeriodicalIF":2.4,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11877203/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540146","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Randomised controlled trial of LGBTQ-affirmative cognitive-behavioural therapy for sexual minority women's minority stress, mental health and hazardous drinking: Project EQuIP protocol.","authors":"John Pachankis, Danielle Chiaramonte, Jillian R Scheer, Hadley Ankrum, Benjamin Eisenstadt, Rebekah Hobbs, Hunter Baldwin, Jeremy D Kidd, Katie Witkiewitz, Denise Ann Esserman, Kendra Plourde, Laurie Drabble, Tonda Hughes","doi":"10.1136/bmjopen-2024-086738","DOIUrl":"10.1136/bmjopen-2024-086738","url":null,"abstract":"<p><strong>Introduction: </strong>Sexual minority women represent one of the highest-risk groups for hazardous drinking and comorbid mental health problems (eg, depression, anxiety). Research has identified cognitive (eg, expectations of rejection), affective (eg, emotion dysregulation) and behavioural (eg, avoidant coping) pathways through which minority stress (eg, stigma) places sexual minority women at disproportionate risk of hazardous drinking and comorbid depression/anxiety; yet no evidence-based interventions have been tested to address these pathways in this population. This article describes the design of Project EQuIP (Empowering Queer Identities in Psychotherapy), a randomised controlled trial of a transdiagnostic lesbian, gay, bisexual, transgender, queer (LGBTQ)-affirmative cognitive-behavioural therapy intervention (CBT) designed to improve minority stress coping and reduce sexual minority women's hazardous drinking and mental health comorbidities.</p><p><strong>Methods and analysis: </strong>This two-arm randomised controlled trial, funded by the National Institute on Alcohol Abuse and Alcoholism, has two objectives: (1) test the efficacy of 10 sessions of LGBTQ-affirmative CBT compared with 10 sessions of supportive counselling for sexual minority women in the community (anticipated n=450) who report hazardous alcohol use and meet criteria for a <i>Diagnostic and Statistical Manual of Mental Disorders - 5</i> diagnosis of a depression or anxiety disorder and (2) examine psychosocial mechanisms and demographic factors as potential mediators and moderators, respectively, of the treatment-outcome relationship. This study's primary outcome is change in the proportion of heavy drinking days. Secondary outcomes are changes in depressive and anxious symptoms.</p><p><strong>Ethics and dissemination: </strong>The Yale University Human Subjects Committee reviewed and approved the research protocol. Results of this study will be disseminated to researchers and practitioners through peer-review publications and conference presentations, and directly to study participants.</p><p><strong>Trial registration number: </strong>Registered on 17 August 2022 (ClinicalTrials.gov identifier: NCT05509166).</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e086738"},"PeriodicalIF":2.4,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11877267/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540221","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Medicinal CANnabis (CBD/THC) to prevent the symptoms and side effects of chemotherapy in people with advanced CANcer (CANCAN): protocol for a phase II, randomised, double-blind, placebo-controlled trial.","authors":"Olivia M Bellas, Katrina Cao, Joanne Bowen, Scott Smid, Sepehr Shakib, Gregory B Crawford, Andrew Zannettino, David T Yeung, Ganessan Kichenadasse, Jarosalv Boublik, Jennie Louise, Julie Marker, Bronwyn Cambareri, Timothy Price, Hannah R Wardill","doi":"10.1136/bmjopen-2024-089336","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-089336","url":null,"abstract":"<p><strong>Introduction: </strong>Many chemotherapy agents used to treat advanced cancer are inherently mucotoxic, causing breakdown of the gastrointestinal mucosa (gastrointestinal mucositis (GI-M)) and lead to a constellation of secondary complications including diarrhoea, malnutrition, anorexia, pain, fatigue and sleep disturbances. These symptoms are usually managed individually, leading to polypharmacy and its associated risks. The endocannabinoid system regulates numerous biological and behavioural processes associated with chemotherapy side effects, suggesting its modulation could control these symptoms. Therefore, the CANnabinoids in CANcer (CANCAN) therapy trial is a phase II, randomised, double-blind, placebo-controlled trial that aims to determine the efficacy of medicinal cannabis in minimising GI-M and its associated symptom burden.</p><p><strong>Methods and analysis: </strong>The CANCAN trial is being conducted at four Australian sites: the Royal Adelaide Hospital, the Queen Elizabeth Hospital, Flinders Medical Centre and the Lyell McEwin Hospital. Adults (n=176) diagnosed with a solid tumour or a haematological cancer scheduled to receive mucotoxic chemotherapy will be eligible. Participants will be randomised 1:1 to receive either the investigational product (IP) or placebo, both delivered as sublingual wafers. The active IP contains cannabidiol (300 mg/day) and Δ⁹-tetrahydrocannabinol (5-20 mg/day, titrated by the participant). The primary outcome is GI-M burden, determined by the Mucositis Daily Questionnaire. Secondary and tertiary outcomes include overall symptom burden (Edmonton Symptom Assessment Scale), anorexia (Average Functional Assessment of Anorexia/Cachexia Therapy), depression/anxiety (Hospital Anxiety and Depression Scale), financial toxicity (Functional Assessment of Chronic Illness Therapy COmprehensive Score for financial Toxicity), quality of life (European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire), incidence of chemotherapy dose reductions/modifications, cumulative dose of chemotherapy administered, incidence/length of hospitalisation, the use of supportive care, and the cost-benefit of the IP. The CANCAN trial prioritises patient experiences by focusing on patient-reported outcome measures and administering medicinal cannabis during active treatment to prevent symptoms that occur secondary to mucositis.</p><p><strong>Ethics and dissemination: </strong>The protocol has been approved by Central Adelaide Local Health Network Human Research Ethics Committee (2022HRE00037). All participants will be required to provide written or digitally authorised informed consent. Trial results will be disseminated in peer-reviewed journals, and at scientific conferences.</p><p><strong>Trial registration number: </strong>ACTRN12622000419763.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e089336"},"PeriodicalIF":2.4,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Modelling analysis of career control sources and critical thinking among nursing undergraduates during the epidemic: a cross-sectional survey study.","authors":"Yan Xiao, Lirong Zhao, Mingzhu Song, Xiao Wei, Yurun Guo, Jie Wan, Wenjing Li, Chan Huang","doi":"10.1136/bmjopen-2024-094073","DOIUrl":"10.1136/bmjopen-2024-094073","url":null,"abstract":"<p><strong>Background: </strong>One of the goals of nursing education is to facilitate the transition of nursing students to nursing positions on graduation, and career locus of control can assess nursing students' expectations and beliefs about their future careers, while 'critical thinking skill' is listed by the International Organization for Medical Education as one of the most essential core competencies for medical graduates.</p><p><strong>Objective: </strong>To investigate the distribution of career locus of control among nursing students before and after the COVID-19 epidemic, to explore the association between career locus of control and critical thinking and to analyse the pathways of influence of critical thinking on career locus of control among nursing students.</p><p><strong>Design and method: </strong>In this study, a total of 456 current undergraduate nursing students were selected online from Chengdu University in China in December 2022 and March 2024, respectively. A career locus of control scale and a critical thinking disposition inventory-Chinese version were used.</p><p><strong>Patient or public involvement: </strong>This study was approved by the Department of Social Science and the School of Medicine of Chengdu University. The researchers explained the purpose of the study to the subjects, so as to obtain their voluntary participation, ensure anonymity and confidentiality, and require each subject to read the informed consent form carefully and have the right to refuse to participate. Two surveys were conducted separately in December 2022 (during the COVID-19 pandemic) and March 2024 (during the normal control period of the epidemic) among 227 and 229 undergraduate nursing students, yielding a full response rate of 100%.</p><p><strong>Result: </strong>There was a correlation between career locus of control and critical thinking, among which career internal control was positively correlated with the score of critical thinking, and low professional efficacy and career opportunities were negatively correlated with the score of critical thinking. Analyticity and inquisitiveness could be used to predict the scores of career internal control, and open-mindedness could be used to predict the scores of critical thinking (β=-0.103). Confidence in reasoning (β=-0.055) could be used to predict the scores of career opportunity. Analyticity and truth-seeking could be used to predict the scores of career external control. The COVID-19 epidemic reduced the career opportunity score by 0.596 points.</p><p><strong>Conclusion: </strong>Nurse educators should recognise the importance of critical thinking training for nursing students, which enables them to adjust their career locus of control by improving critical thinking and may influence professional expectations, improve self-image within the nursing profession and increase retention of nurses.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e094073"},"PeriodicalIF":2.4,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11877268/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540205","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prospective harmonisation of four international randomised controlled trials in Canada, China, India and South Africa: the Healthy Life Trajectories Initiative.","authors":"Julie Bergeron, Anouar Nechba, Samuel El Bouzaïdi Tiali, Stephanie Atkinson, Catherine Birken, Catherine Draper, Ghattu V Krishnaveni, William Fraser, Cindy Lee Dennis, Nadia Abdelouahab, Flavia Marini, Kalyanaraman Kumaran, Shane A Norris, Stephen Lye, Stephen G Matthews, He-Feng Huang, Elizabeth A Bojarski, Rayjean Hung, Jianxia Fan, Jean-Patrice Baillargeon, Isabel Fortier","doi":"10.1136/bmjopen-2024-086233","DOIUrl":"10.1136/bmjopen-2024-086233","url":null,"abstract":"<p><strong>Objectives: </strong>The Healthy Life Trajectories Initiative (HeLTI) is an international multistudy consortium that supports the development and integration of four randomised controlled trials (RCTs) conducted in South Africa, India, China and Canada. HeLTI aims to evaluate interventions to improve the health and well-being of mothers and children, starting from preconception through pregnancy and early childhood until age 5 years. This paper describes the process by which we prospectively harmonised the participating studies and provides a descriptive analysis of the study-specific harmonisation potential.</p><p><strong>Design: </strong>Prospective harmonisation of four international RCTs.</p><p><strong>Methods: </strong>A list of core variables to be collected across ten waves of data collection was defined. Taking this list into consideration, investigators developed country-specific questionnaires that were then assessed and adjusted to optimise the harmonisation potential across countries. As questionnaires were not identical, where required, processing scripts were generated to help transform the collected data into the core variable format.</p><p><strong>Setting: </strong>The four RCTs are conducted in Canada, China, India and South Africa. The prospective harmonisation was led by the Maelstrom Research team in Canada.</p><p><strong>Participants: </strong>Between 4500 and 6000 women planning to get pregnant are recruited in each RCT. Women remain in the study if they become pregnant inside the planned interval of 1-3 years, depending on the country.</p><p><strong>Results: </strong>A total of 1962 variables from questionnaires, physical measurements and biospecimen analyses were defined across 10 timepoints of data collection and 3 subpopulations (mothers, partners and children). These variables cover 47 different domains of information. For the preconception phase, following the development of questionnaires and their implementation in the data collection software, 77.2% of the core variables defined can be created across the four studies.</p><p><strong>Conclusion: </strong>The HeLTI harmonisation process was successful, and the datasets generated represent a valuable resource allowing researchers to address a wide range of research questions on the impact of behaviour change interventions on maternal and child health indicators in different populations.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e086233"},"PeriodicalIF":2.4,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11877250/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reasons for emergency department use of low-acuity attender: results from the prospective, multicentre, cross-sectional EPICS-9/PiNo-Bund study.","authors":"Anna Slagman, Martina Schmiedhofer, David Legg, Daniela Krüger, Larissa Eienbröker, Fabian Holert, Johann Frick, Dagmar Lühmann, Ingmar Schäfer, Martin Scherer, Bernadett Erdmann, Martin Möckel","doi":"10.1136/bmjopen-2024-090681","DOIUrl":"10.1136/bmjopen-2024-090681","url":null,"abstract":"<p><strong>Background: </strong>The number of low-acuity emergency department (ED) visits varies across Europe and is often posited as a contributing factor to ED crowding. Many health policy-makers and health professionals assume that these cases are 'avoidable' ED visits or could be referred to other ambulatory healthcare providers.</p><p><strong>Objectives: </strong>This study examines the care-seeking behaviour and the reasoning behind patients with low-acuity ED attendance according to emergency triage.</p><p><strong>Design and setting: </strong>In a prospective multicentre cross-sectional survey, patients were invited to participate in an anonymised, paper-based survey in the waiting areas of nine EDs in Germany (2018-2020). The survey included questions on sociodemographic characteristics, reasons for using the ED, previous consultations in the outpatient healthcare system, self-rated urgency and knowledge of other emergency care structures. Due to the variance of missing values in the different responses, the valid percentages are shown.</p><p><strong>Results: </strong>Of the 2752 survey respondents, 41.1% (n=1 120) indicated that 'pain' was the primary complaint for their ED attendance. Self-rated urgency was 'less urgent' for 58.7% (n=1552), 'urgent' for 41.3% (n=1093) and 57.7% reported the first episode of their symptoms (n=1505), with 30.8% (n=830) with symptom onset on the same day. The majority of patients completed the survey on weekdays (94.6%) between 08:00 and 18:00 (82.2%). 80.1% stated that they had a general practitioner (GP) (n=2103) and 55.8% contacted their GP before attending the ED (n=1403). In 77.8% of patients with GP contact, a visit to the ED was recommended by practice members or the GP (n=1068). The on-call service of the statutory health insurance physicians (SHIP) was contacted by 7.0% (n=172); in 64.6% of these cases (n=115), an ED visit was recommended. Of all patients without contact to the SHIP on-call service, 60.6% stated that they were not aware of these services (n=848).</p><p><strong>Conclusions: </strong>Patients with low-acuity ED attendance stated acute onset and mainly new episodes of symptoms, with pain being the most common chief complaint. A high proportion reported having contacted their GP or SHIP on-call services (if known) but have been referred to the ED. As long as no fundamental changes are made to the provision of timely treatment options in the outpatient care sector, EDs may continue to be the foremost treatment option for these patients.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e090681"},"PeriodicalIF":2.4,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11877155/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"London's Ultra Low Emission Zone and active travel to school: a qualitative study exploring the experiences of children, families and teachers.","authors":"Olivia Alliott, Esther van Sluijs, Rosamund Dove, Harpal Kalsi, Jessica Mitchell, Ian Mudway, Gurch Randhawa, Luke Sartori, James Scales, Helen E Wood, Chris Griffiths, Cornelia Guell, Jenna Panter","doi":"10.1136/bmjopen-2024-091929","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-091929","url":null,"abstract":"<p><strong>Objective: </strong>Taking a qualitative approach, we aimed to understand how London's Ultra Low Emission Zone (ULEZ) might work to change behaviour and improve health in the context of the school journey.</p><p><strong>Design: </strong>Primary qualitative study embedded within an existing natural experimental study.</p><p><strong>Setting: </strong>A population-level health intervention implemented across London.</p><p><strong>Participants: </strong>Purposive sampling was used to recruit children (aged 10-11 years) from ethnically and socioeconomically diverse backgrounds within an existing cohort study, Children's Health in London and Luton.</p><p><strong>Methods: </strong>In-person and online interviews were conducted with 21 families and seven teachers from the children's schools between November 2022 and March 2023. Verbatim transcripts were analysed drawing on Braun and Clarke's reflexive thematic analysis and guided by realist evaluation principles to identify contexts, mechanisms and outcomes using NVivo.</p><p><strong>Results: </strong>Common context, mechanism, outcome (CMO) configurations were identified reflecting congruent narratives across children, parents and teachers, for example, current active travellers (context) reported reductions in pollution (mechanism) leading to improvements in health, including alleviated symptoms of asthma (outcome). These CMOs were broadly captured by two themes: (i) how you travelled before the ULEZ matters: the impact of travel mode on experiences of the ULEZ and (ii) your context matters: the role of socioeconomic position in experiences of the ULEZ. Participants highlighted the potential for the ULEZ to positively impact their choice of travel mode to school, experiences of the journey and their health. However, the impact of the ULEZ differed inequitably by journey length, travel mode before implementation and access to reliable and affordable public transport.</p><p><strong>Conclusions: </strong>The capacity for the ULEZ to both narrow and exacerbate inequities across different travel contexts suggests when developing such schemes, more emphasis needs to be placed on providing accessible and affordable alternatives to driving.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e091929"},"PeriodicalIF":2.4,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540183","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}