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Co-developing a vocational rehabilitation intervention for individuals with chronic low back pain across a regional spine centre and three municipalities in Denmark: a three-stage intervention development study guided by the Medical Research Council framework. 在丹麦的一个区域脊柱中心和三个城市共同为患有慢性腰痛的个人制定职业康复干预措施:一项由医学研究委员会框架指导的三阶段干预发展研究。
IF 2.3 3区 医学
BMJ Open Pub Date : 2026-05-08 DOI: 10.1136/bmjopen-2025-116084
Gitte Frydenlund, Ole Steen Mortensen, Søren O'Neill, Jens Søndergaard, Anders Hansen
{"title":"Co-developing a vocational rehabilitation intervention for individuals with chronic low back pain across a regional spine centre and three municipalities in Denmark: a three-stage intervention development study guided by the Medical Research Council framework.","authors":"Gitte Frydenlund, Ole Steen Mortensen, Søren O'Neill, Jens Søndergaard, Anders Hansen","doi":"10.1136/bmjopen-2025-116084","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-116084","url":null,"abstract":"<p><strong>Objectives: </strong>To co-develop the Stay-At-Work (SAW) intervention, a person-centred, interdisciplinary, cross-sectoral vocational rehabilitation (VR) programme for individuals on, or at risk of, sick leave due to chronic low back pain (CLBP) and to advance methodological understanding of how evidence, qualitative insights, stakeholder input and programme theory can be systematically integrated and operationalised into concrete intervention components.</p><p><strong>Design: </strong>A three-stage intervention development study, guided by the Medical Research Council framework for complex interventions, involving evidence review and stakeholder consultation (previously reported); multistakeholder co-design; and prototyping in clinical settings.</p><p><strong>Setting: </strong>The intervention was developed within a Danish public healthcare and welfare context, involving a secondary care spinal service, municipal employment services (n=3), municipal rehabilitation services (n=3) and general practice.</p><p><strong>Participants: </strong>Stage 1: 17 individuals on long-term sick leave due to CLBP participated in interviews and focus groups. Stages 2 and 3: The co-design group included individuals living with CLBP (n=2); clinicians from a secondary care spine service (n=2) and municipal rehabilitation services (n=6); general practitioners (n=2); municipal employment service professionals (n=3) and local managers (n=3); and employer and employee representatives (n=2). Participants were purposively recruited based on their roles and experience in VR and return-to-work processes and contributed across different stages of intervention development.</p><p><strong>Results: </strong>The SAW intervention consists of eight structured activities, developed through multistakeholder co-design and underpinned by a programme theory with four core mechanisms: (1) strengthened interprofessional and cross-sectoral understanding and collaboration; (2) stronger alignment around functional capacity and work ability; (3) addressing psychological vulnerability through systematic screening and support; and (4) enhanced coordination of care and rehabilitation efforts across services.Stakeholder input from the co-design group informed the intervention's content and procedures, thereby improving alignment with local contexts and strengthening cross-sector collaboration. Some proposals were excluded due to inconsistency with clinical guidelines.</p><p><strong>Conclusion: </strong>This study demonstrates how a structured, theory-informed co-development process can be used to integrate evidence, stakeholder input and programme theory into a coherent, cross-sectoral VR intervention. The approach enhanced transparency, supported alignment with real-world practice, and provides methodological insight to strengthen the reproducibility and transferability of complex interventions.<b>Registration number</b>: The Region of Southern Denmark's Research Registry (journal no.","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 5","pages":"e116084"},"PeriodicalIF":2.3,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147855815","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}
引用次数: 0
Comparing Mechanical Diagnosis and Therapy with generalised exercise for chronic spinal pain in surgeons: protocol for a pragmatic randomised controlled trial. 外科医生慢性脊柱疼痛的机械诊断和治疗与广泛运动的比较:一项实用的随机对照试验方案。
IF 2.3 3区 医学
BMJ Open Pub Date : 2026-05-08 DOI: 10.1136/bmjopen-2026-117630
Claus Kjærgaard, Pascal Madeleine, Annett Dalbøge, Benjamin Steinhilber, Anne Vingaard Olesen, Tommy Kjærgaard Nielsen
{"title":"Comparing Mechanical Diagnosis and Therapy with generalised exercise for chronic spinal pain in surgeons: protocol for a pragmatic randomised controlled trial.","authors":"Claus Kjærgaard, Pascal Madeleine, Annett Dalbøge, Benjamin Steinhilber, Anne Vingaard Olesen, Tommy Kjærgaard Nielsen","doi":"10.1136/bmjopen-2026-117630","DOIUrl":"https://doi.org/10.1136/bmjopen-2026-117630","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic musculoskeletal pain is an occupational health concern among surgeons, with spinal pain being commonly reported. Exercise-based physiotherapy is recommended for reducing chronic spinal pain; however, the treatment effects are modest and may vary across clinical subgroups. Mechanical Diagnosis and Therapy (MDT) is a classification-based approach that uses a standardised clinical examination to guide exercise-based interventions and self-management strategies, and may offer advantages over non-direction-specific generalised exercise in selected patients.</p><p><strong>Methods and analysis: </strong>This pragmatic, two-arm, parallel-group randomised controlled superiority trial will compare MDT with generalised exercise in surgeons with chronic spinal pain and a confirmed directional preference, with a planned recruitment of 62 participants (31 per group). Participants will be randomised 1:1 using a computer-generated allocation sequence in Research Electronic Data Capture (REDCap), with stratification by sex and permuted blocks of undisclosed size. Interventions will be delivered in routine physiotherapy practice with flexible scheduling within predefined boundaries (maximum six supervised sessions; most expected within the first 12 weeks), with a follow-up period of 26 weeks.The primary outcome is the between-group difference in average pain intensity over the preceding 7 days at 12 weeks, measured using the Numeric Pain Rating Scale and adjusted for baseline pain intensity.The secondary and exploratory outcomes include functional limitations, health-related quality of life, fear of movement, pain catastrophising, pain self-efficacy, therapeutic alliance, exercise adherence and patient global impression of change, assessed at baseline and at 4, 12 and 26 weeks (where applicable). Treatment effects will be analysed using linear mixed-effects models under the intention-to-treat principle.</p><p><strong>Ethics and dissemination: </strong>Ethical approval has been obtained from the North Denmark Region Committee on Health Research Ethics (N-20240046). The findings will be disseminated through peer-reviewed publications and conference presentations.</p><p><strong>Trial registration number: </strong>NCT07293130.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 5","pages":"e117630"},"PeriodicalIF":2.3,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147855833","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}
引用次数: 0
Can social prescribing intervention reduce unplanned hospital usage in an ethnically diverse and deprived population: a quasi-experimental study using a dynamic staggered difference-in-differences approach. 社会处方干预能否减少种族多样化和贫困人群的计划外医院使用:一项使用动态交错差异方法的准实验研究。
IF 2.3 3区 医学
BMJ Open Pub Date : 2026-05-08 DOI: 10.1136/bmjopen-2025-107259
Bo Hou, Rachael H Moss, Mohammed Hammad, Sohail Abbas, Michael McCooe, John Wright, John Wildman, Trevor Sheldon, Josie Dickerson
{"title":"Can social prescribing intervention reduce unplanned hospital usage in an ethnically diverse and deprived population: a quasi-experimental study using a dynamic staggered difference-in-differences approach.","authors":"Bo Hou, Rachael H Moss, Mohammed Hammad, Sohail Abbas, Michael McCooe, John Wright, John Wildman, Trevor Sheldon, Josie Dickerson","doi":"10.1136/bmjopen-2025-107259","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-107259","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to evaluate the impact of a social prescribing intervention (the Central Locality Integrated Care Service (CLICS)) on unplanned hospital usage in the city of Bradford.</p><p><strong>Design: </strong>A quasi-experimental study applying a dynamic staggered difference-in-differences (DID) analysis on a propensity matched cohort between 2019 and 2023, using data from the Connected Bradford dataset, a pseudonymised linked health dataset on the whole Bradford population.</p><p><strong>Setting: </strong>CLICS was delivered within general practices in deprived and ethnically diverse inner-city areas of Bradford, Yorkshire, UK.</p><p><strong>Participants: </strong>In total, 1304 CLICS patients were matched to 5216 control patients on key characteristics including ethnicity, deprivation, age, gender and health conditions.</p><p><strong>Interventions: </strong>A proactive social prescribing intervention that integrates clinical and non-clinical services, including an individualised approach to tailor support based on the patient's needs, both within primary care services and by linking them to appropriate community-based assets/services.</p><p><strong>Primary and secondary outcome measures: </strong>The primary outcome was the rate of unplanned hospital admissions and the secondary outcome was unplanned accident and emergency (A&E) attendances.</p><p><strong>Results: </strong>CLICS patients were 2.1% (95% CI -3.8% to -0.4%, p=0.013) less likely to have an unplanned hospital admission and 2.4% (95% CI -4.6% to -0.2%, p=0.03) less likely to have an unplanned A&E attendance compared with the matched control. The DID analysis demonstrated a gradual increase in the association over time. Subanalyses revealed heterogeneity by ethnicity, the reduction in unplanned hospital admissions was observed only in patients of the Pakistani group, whereas the reduction in A&E attendances was statistically significant only in the white British group.</p><p><strong>Conclusion: </strong>The CLICS intervention was associated with a reduction in unplanned hospital usage. Social prescribing may be a valuable component of strategies to reduce health inequalities in unplanned hospital usage.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 5","pages":"e107259"},"PeriodicalIF":2.3,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147855869","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}
引用次数: 0
Lithium versus lamotrigine in bipolar disorder type II: protocol for a single-blinded, pragmatic, randomised controlled trial (the LiLa-Bipolar RCT). 锂与拉莫三嗪治疗II型双相情感障碍:一项单盲、实用、随机对照试验方案(LiLa-Bipolar RCT)
IF 2.3 3区 医学
BMJ Open Pub Date : 2026-05-08 DOI: 10.1136/bmjopen-2026-116196
Mette Ungermann Fredskild, Caroline Fussing Fussing Bruun, Kamilla Woznica Miskowiak, Esben Budtz-Jørgensen, Maj Vinberg, Maria Faurholt-Jepsen, Lars Vedel Kessing
{"title":"Lithium versus lamotrigine in bipolar disorder type II: protocol for a single-blinded, pragmatic, randomised controlled trial (the LiLa-Bipolar RCT).","authors":"Mette Ungermann Fredskild, Caroline Fussing Fussing Bruun, Kamilla Woznica Miskowiak, Esben Budtz-Jørgensen, Maj Vinberg, Maria Faurholt-Jepsen, Lars Vedel Kessing","doi":"10.1136/bmjopen-2026-116196","DOIUrl":"https://doi.org/10.1136/bmjopen-2026-116196","url":null,"abstract":"<p><strong>Introduction: </strong>Bipolar II disorder (BDII) accounts for the majority of patients with bipolar disorder (BD), yet evidence supporting first-line mood stabilising treatment with lithium and lamotrigine is scarce, and the certainty of the evidence is very low. This highlights a critical evidence gap within psychiatric care. The lithium versus lamotrigine-bipolar randomised controlled trial (RCT) aims to compare lithium and lamotrigine on self-rated day-to-day mood instability (MI) and other patient-centred outcomes in BDII, hypothesising the superiority of lithium.</p><p><strong>Methods and analysis: </strong>A two-arm, single-blind, parallel-group, superiority RCT with a target sample size of 200 patients (accounting for attrition), recruiting patients with newly diagnosed BDII from specialised outpatient mood disorder clinics in the capital region of Copenhagen, Denmark. Participants are randomised in a 1:1 ratio to receive either lithium or lamotrigine for 6 months. The primary outcome is MI, assessed via daily smartphone-based mood ratings. MI is chosen as the primary outcome measure due to its internal validity as a real-life measure for patients and external validity as it reflects both illness severity and functional impairment. Secondary outcomes include the proportion of participants showing a non-response to treatment and observer-rated changes in depressive symptoms over 6 months, measured using the six-item version of the Hamilton Depression Rating Scale. Primary analyses will follow the intention-to-treat principle using linear mixed models. The trial is monitored by the good clinical practice.Recruitment commenced on 8 May 2024, and the final participant follow-up (last patient last visit) is expected on 1 December 2027.</p><p><strong>Ethics and dissemination: </strong>The trial has received approvals from the Danish Research Ethics Committee, the Danish Medicines Agency (EU CT No. 2023-5 09 607-32-00) and the Capital Region Data Agency (P-2023-307). Results will be published in peer-reviewed journals.</p><p><strong>Trial registration number: </strong>Clinicaltrials.gov/NCT06184581.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 5","pages":"e116196"},"PeriodicalIF":2.3,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147855879","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}
引用次数: 0
Healthcare utilisation patterns among frail individuals aged 50+ years: results from the Lolland-Falster Population Study (LOFUS). 50岁以上体弱个体的医疗保健利用模式:来自Lolland-Falster人口研究(LOFUS)的结果。
IF 2.3 3区 医学
BMJ Open Pub Date : 2026-05-08 DOI: 10.1136/bmjopen-2025-110096
Katja Kemp Jacobsen, Mathilde Glud Christensen, Charlotte Nilsson, Randi Jepsen, Lau Thygesen, Charlotte Suetta, Ellen Astrid Holm
{"title":"Healthcare utilisation patterns among frail individuals aged 50+ years: results from the Lolland-Falster Population Study (LOFUS).","authors":"Katja Kemp Jacobsen, Mathilde Glud Christensen, Charlotte Nilsson, Randi Jepsen, Lau Thygesen, Charlotte Suetta, Ellen Astrid Holm","doi":"10.1136/bmjopen-2025-110096","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-110096","url":null,"abstract":"<p><strong>Objectives: </strong>Frailty is a clinical syndrome characterised by impaired homeostatic mechanisms and reduced physiological reserve. Hospital admissions for ambulatory care sensitive conditions (ACSCs) are commonly used as indicators of quality in primary healthcare. We aimed to examine the association between frailty and the use of healthcare resources, including unplanned hospital visits due to ACSCs and non-ACSCs and visits to general practitioners (GPs) and medical specialists (MSs) in primary care. We hypothesised that frail individuals would have similar odds of hospital visits due to ACSCs and non-ACSCs.</p><p><strong>Design: </strong>Registry-based epidemiological study.</p><p><strong>Setting: </strong>Data from the Danish Lolland-Falster Health Study and national health registers. Data were collected in a rural region of Denmark between February 2016 and February 2020.</p><p><strong>Participants: </strong>10 154 randomly selected individuals aged ≥50 years participating in the Lolland-Falster Health Study with valid frailty measurements.</p><p><strong>Outcome measures: </strong>Hospital visits due to any diagnosis, hospital visits due to ACSCs and non-ACSCs, and visits to GPs and MSs in the primary care sector.</p><p><strong>Results: </strong>After adjustment for age, sex, comorbidity and socioeconomic factors, frail participants had higher odds of hospital visits due to any diagnosis (OR 1.27, 95% CI 1.02 to 1.57; p=0.03). The odds of hospital visits due to ACSCs (OR 1.42, 95% CI 0.97 to 2.08; p=0.07) and non-ACSCs (OR 1.16, 95% CI 0.91 to 1.47; p=0.22) were not significantly different. Frail individuals had higher odds of visiting their GP (OR 1.21, 95% CI 1.00 to 1.46; p=0.047) but not a medical specialist (OR 0.82, 95% CI 0.62 to 1.07; p=0.15).</p><p><strong>Conclusions: </strong>Among frail individuals, the distinction between unplanned hospital visits due to ACSCs and non-ACSCs is not meaningful. This finding is consistent with the understanding of frailty as a state of reduced physiological reserve, in which minor stressors may lead to hospital care regardless of diagnostic category.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 5","pages":"e110096"},"PeriodicalIF":2.3,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147855899","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}
引用次数: 0
Emotional intelligence intervention to improve mental well-being of adolescents with emotional distress (BEAM): study protocol for a randomised controlled trial. 情绪智力干预改善情绪困扰青少年心理健康(BEAM):一项随机对照试验的研究方案。
IF 2.3 3区 医学
BMJ Open Pub Date : 2026-05-08 DOI: 10.1136/bmjopen-2026-118438
Carme Pedrosa-Vazquez, Raquel Ayuso-Margañon, Cristina Lidón-Moyano, Pilar Morales, Leyre Cañas, Cristina Garriga-Salvó, Briggitte Farfan-Dominguez, Silvia Rey-Vitó, Maria Llistosella
{"title":"Emotional intelligence intervention to improve mental well-being of adolescents with emotional distress (BEAM): study protocol for a randomised controlled trial.","authors":"Carme Pedrosa-Vazquez, Raquel Ayuso-Margañon, Cristina Lidón-Moyano, Pilar Morales, Leyre Cañas, Cristina Garriga-Salvó, Briggitte Farfan-Dominguez, Silvia Rey-Vitó, Maria Llistosella","doi":"10.1136/bmjopen-2026-118438","DOIUrl":"https://doi.org/10.1136/bmjopen-2026-118438","url":null,"abstract":"<p><strong>Introduction: </strong>Adolescents experiencing emotional distress are at increased risk of developing mental health problems, which can negatively impact their academic performance, social relationships and long-term well-being. Schools provide a key setting for implementing preventive interventions that promote emotional and psychological resilience. This study presents the protocol for a randomised controlled trial designed to evaluate the effectiveness of a multicomponent, school-based intervention grounded in emotional intelligence (EI) in improving mental well-being, EI levels and resilience among adolescents aged 14-16 years experiencing emotional distress.</p><p><strong>Methods and analysis: </strong>The trial will be conducted in public and publicly funded secondary schools in Terrassa, Spain, during the 2025-2026 academic year. Eligible participants will be identified using the short version of the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). The intervention consists of nine 55-minute group sessions delivered during school hours by a nurse and a physiotherapist, supported by the school's psychopedagogue. Sessions focus on emotional regulation, self-esteem, mindfulness, assertiveness and other socio-emotional skills. Assessments will be conducted at baseline, postintervention and 24-week follow-up. The primary outcome is mental well-being (WEMWBS); secondary outcomes include EI (Trait Meta-Mood Scale-24 items) and resilience (Child and Youth Resilience Measure-32 items). It is anticipated that adolescents in the intervention group will show significantly greater improvements in mental well-being, emotional intelligence and resilience compared with the control group, with effects sustained at follow-up. This study will provide evidence on the effectiveness of a scalable, school-based intervention led by community health professionals. The programme could be integrated into educational and public health strategies to promote adolescent mental health and reduce emotional distress.</p><p><strong>Ethics and dissemination: </strong>Approved by CEIm Consorci Sanitari de Terrassa (01-24-1CR-102). Low-risk study; predefined procedures are in place for participants at risk (eg, suicidal ideation, abuse) with referral pathways to health/social services. Findings will be disseminated via peer-reviewed publications, conferences and a plain-language summary to schools/stakeholders.</p><p><strong>Trial registration number: </strong>NCT06713460.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 5","pages":"e118438"},"PeriodicalIF":2.3,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147855902","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}
引用次数: 0
Enhancing maternal autonomy in choosing birthing positions: an exploratory pre-post intervention study protocol (MAM-Care). 增强产妇自主选择分娩位置:一项探索性干预前-后研究方案(MAM-Care)。
IF 2.3 3区 医学
BMJ Open Pub Date : 2026-05-08 DOI: 10.1136/bmjopen-2025-114260
Mi-Ran Okumu, Lissa Haid-Schmallenberg, Niklas Sand, Arno Stöcker, Anna Volkert, Nadine Scholten
{"title":"Enhancing maternal autonomy in choosing birthing positions: an exploratory pre-post intervention study protocol (MAM-Care).","authors":"Mi-Ran Okumu, Lissa Haid-Schmallenberg, Niklas Sand, Arno Stöcker, Anna Volkert, Nadine Scholten","doi":"10.1136/bmjopen-2025-114260","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-114260","url":null,"abstract":"<p><strong>Introduction: </strong>Although evidence on whether particular birthing positions offer advantages over others remains inconclusive, the majority of women give birth in the supine position. Earlier research associates maternal satisfaction with autonomy and active participation in choosing positions, irrespective of the clinical outcome. In practice, however, autonomy may be limited by the dynamics of labour, insufficient information and sociocultural norms. Against this background, the intervention aims to enhance maternal autonomy in childbirth through the provision of activating information materials and psychological nudges. Women shall be encouraged to explore various positions enabling them to autonomously choose positions that best align with their individual needs.</p><p><strong>Methods and analysis: </strong>Using an exploratory pre-post design, this controlled intervention is carried out as a multicentre study in six German obstetrics departments. The intervention will include various ways to inform and nudge women to move and try out various positions autonomously during childbirth. Due to its minimally invasive character, it should easily integrate into organisational processes and everyday care. The primary endpoint of the study is the proportion of mothers who indicate that their final birthing position felt appropriate. Secondary endpoints include the proportion of upright positions as final birthing positions and maternal and neonatal health outcomes among others. Data sources include maternal longitudinal data, birth companions' and midwives'/physicians' perspectives as well as clinical sheets and aggregated comparisons.</p><p><strong>Ethics and dissemination: </strong>This study obtained ethical approval from the Ethics Committee of the Medical Faculty of the University of Bonn and the Medical Chamber of Nordrhein (2025-325 BO). All study procedures will adhere to relevant data protection regulations. Dissemination of project information, materials and results will take place through the project homepage, social media and peer-reviewed journals.</p><p><strong>Trial registration number: </strong>DRKS00036899; (https://drks.de/search/en/trial/DRKS00036899/entails).</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 5","pages":"e114260"},"PeriodicalIF":2.3,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147855905","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}
引用次数: 0
Model of care to promote recovery in older people with long COVID: findings from interviews and a co-design workshop. 促进长期患病老年人康复的护理模式:来自访谈和共同设计研讨会的结果。
IF 2.3 3区 医学
BMJ Open Pub Date : 2026-05-08 DOI: 10.1136/bmjopen-2025-109911
Kisani Manuel, Aaron Davis, Kate Little, Fanke Peng, Ian Gwilt, Kate Laver, Zoe Adey-Wakeling, Chantel Seaforth, Maria Crotty
{"title":"Model of care to promote recovery in older people with long COVID: findings from interviews and a co-design workshop.","authors":"Kisani Manuel, Aaron Davis, Kate Little, Fanke Peng, Ian Gwilt, Kate Laver, Zoe Adey-Wakeling, Chantel Seaforth, Maria Crotty","doi":"10.1136/bmjopen-2025-109911","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-109911","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to co-design a tailored model of care for older people with long COVID.</p><p><strong>Design: </strong>Using a human-centred design approach, semistructured interviews were conducted with patients and health professionals from a long COVID service to explore their experiences. Insights were further developed during a co-design workshop involving patients, health professionals and community members who identified as older people and who had experience with chronic illness. Key themes were identified and used to map an ideal patient journey and inform the final model of care.</p><p><strong>Setting: </strong>Long COVID outpatient service in a tertiary hospital in Adelaide, South Australia.</p><p><strong>Participants: </strong>Four patients and four health professionals participated in the interviews. The workshop included four patients, five health professionals and seven community members.</p><p><strong>Results: </strong>The co-design process identified challenges experienced by people with long COVID, including lack of validation, delayed multidisciplinary care, mental health deterioration and difficulties navigating the healthcare system. These challenges were described as having particular relevance for older adults. In response, a model of care was developed focused on comprehensive assessment, coordinated multidisciplinary care, education for self-management, mental health support and opportunities for research participation.</p><p><strong>Conclusions: </strong>A comprehensive and adaptable model of care is needed to address the complex and multifaceted nature of long COVID. This human-centred design approach ensured the model was grounded in lived experience, clinically informed and aligned with patient priorities. While not unique to older adults, the findings highlight areas that may require particular attention in this population, including care coordination, validation and support for comorbidities and social vulnerabilities. While developed in a single tertiary service, these principles may inform the design of services for similar populations in other healthcare settings.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 5","pages":"e109911"},"PeriodicalIF":2.3,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147855828","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}
引用次数: 0
Determinants of pain, anxiety and patient satisfaction during intravenous injection: a cross-sectional study. 静脉注射期间疼痛、焦虑和患者满意度的决定因素:一项横断面研究。
IF 2.3 3区 医学
BMJ Open Pub Date : 2026-05-08 DOI: 10.1136/bmjopen-2026-119450
Güzel Nur Yıldız, Hanım Duru Yüce Başaran, Burak Yavuz, Dilara Koçyiğit, Gamze Koç, Bahar Çiftçi
{"title":"Determinants of pain, anxiety and patient satisfaction during intravenous injection: a cross-sectional study.","authors":"Güzel Nur Yıldız, Hanım Duru Yüce Başaran, Burak Yavuz, Dilara Koçyiğit, Gamze Koç, Bahar Çiftçi","doi":"10.1136/bmjopen-2026-119450","DOIUrl":"https://doi.org/10.1136/bmjopen-2026-119450","url":null,"abstract":"<p><p>BackgroundIntravenous injection is one of the most frequently performed invasive nursing procedures in hospitals. However, patients may experience pain and anxiety during this procedure, which can affect patient satisfaction.</p><p><strong>Objective: </strong>The aim of this study was to determine the levels of pain, anxiety and satisfaction in patients undergoing intravenous injection and to examine the sociodemographic, clinical and procedural factors affecting these levels.</p><p><strong>Methods: </strong>A descriptive, cross-sectional study was conducted between August and November 2025 in the emergency departments of Atatürk University Research Hospital, a large tertiary care university hospital. This single-centre study was carried out in a high-volume emergency department that provides 24-hour services to a diverse patient population. A total of 405 patients who received intravenous injections and agreed to participate in the study were included. Data were collected using an Information Form, Visual Analogue Scale (VAS) for pain, VAS for anxiety and Post-Injection Satisfaction Scale. Descriptive statistics, t-tests, analysis of variance, correlation analyses and multiple regression analyses were used to analyse the data.</p><p><strong>Results: </strong>The mean pain VAS score for patients was 4.39±2.33, the mean anxiety VAS score was 4.42±2.14 and the mean Post-Injection Satisfaction Scale score was 3.51±0.77, indicating moderate levels of pain and anxiety on a 0-10 VAS. Women were found to have significantly higher levels of pain and anxiety than men (p<0.05). Low educational level, chronic disease, poorer perceived general health, negative intravenous experience, frequent injections, low pain tolerance and prolonged pain were associated with higher pain and anxiety levels and lower satisfaction levels (p<0.05). A strong positive correlation was found between pain and anxiety (r=0.656, p<0.05), while a negative correlation was found between pain, anxiety and satisfaction (p<0.05). Multiple regression analysis showed that lower pain tolerance and longer pain duration were among the most clinically relevant variables associated with higher pain and anxiety levels, particularly pain tolerance and pain duration, together with perceived general health status and procedure-related variables.</p><p><strong>Conclusion: </strong>It was found that patients experienced moderate pain and anxiety during intravenous injection and that this situation negatively affected patient satisfaction. The results indicate that individualised nursing approaches in intravenous injection practices and the implementation of pharmacological and non-pharmacological interventions aimed at reducing pain and anxiety may increase patient satisfaction.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 5","pages":"e119450"},"PeriodicalIF":2.3,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147855896","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}
引用次数: 0
Multimodal personalised executive function intervention (E-Fit) for school-aged children with complex congenital heart disease in Switzerland: a randomised controlled feasibility study. 瑞士学龄儿童复杂先天性心脏病的多模式个性化执行功能干预(E-Fit):一项随机对照可行性研究
IF 2.3 3区 医学
BMJ Open Pub Date : 2026-05-08 DOI: 10.1136/bmjopen-2025-107681
Alenka S Schmid, Melanie Ehrler, Silvia A Bunge, Oliver Kretschmar, Markus A Landolt, Valentin Rousson, Ruth O'Gorman Tuura, Flavia M Wehrle, Beatrice Latal
{"title":"Multimodal personalised executive function intervention (E-Fit) for school-aged children with complex congenital heart disease in Switzerland: a randomised controlled feasibility study.","authors":"Alenka S Schmid, Melanie Ehrler, Silvia A Bunge, Oliver Kretschmar, Markus A Landolt, Valentin Rousson, Ruth O'Gorman Tuura, Flavia M Wehrle, Beatrice Latal","doi":"10.1136/bmjopen-2025-107681","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-107681","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To explore the feasibility of a novel multimodal executive function intervention in school-aged children with complex congenital heart disease (cCHD).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design: &lt;/strong&gt;Single-centre, single-blinded, randomised-controlled 8-week multimodal personalised executive function intervention (E-Fit) study. Outcomes were measured throughout the intervention, post-intervention (T1) and at 4-month follow-up (T2).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Setting: &lt;/strong&gt;Tertiary care centre between May 2022 and May 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Participants: &lt;/strong&gt;Children 10 to 12 years (M=11.0, SD=0.9) with cCHD without a genetic diagnosis with infant open-heart surgery and reported difficulties (T-scores ≥60) on any of the summary scales of the parent- or teacher-reported Behavior Rating Inventory for Executive Function (BRIEF).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interventions: &lt;/strong&gt;Children with cCHD were randomly assigned to one of two groups: the intervention or the control group. The 8-week intervention was multimodal including three modalities: (1) computerised executive function (EF) training 3×20 min/week with CogniFit; (2) a weekly, remote standardised 1:1 individual EF strategy coaching; (3) analogue games played at convenience. The control group completed activity logs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Feasibility measures: &lt;/strong&gt;Acceptability: Acceptance and Feasibility Scale (AFS) and coach-rated engagement during coaching sessions. Demand: Number of completed computerised training, strategy coaching and analogue game sessions.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Implementation: &lt;/strong&gt;E-Fit Fidelity Measurement System, assessing adherence to core components. Practicality: Retention rate. Integration: AFS integration items. Exploratory efficacy: BRIEF, neuropsychological EF testing and psychosocial variables at baseline, post-intervention (8 weeks) and at 4-month follow-up.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;We recruited 42 participants (N&lt;sub&gt;female&lt;/sub&gt;=20). Acceptability: The intervention was acceptable, with moderate observed engagement. Demand: median number of computerised training sessions completed was 16 of 24 sessions (67%, (IQR; 6 to 19)), all children attended all scheduled coaching sessions, analogue games were played in total a median of 9 times (IQR 4 to 14).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Implementation: &lt;/strong&gt;Coaching sessions could be implemented by the coaches as intended. Practicality: Overall retention rate was 90%. Integration: E-Fit was well integrable into the home setting. Exploratory efficacy favoured the intervention group with improvements in the parent-rated Behavioral Regulation Index of the BRIEF (adjusted Hedge's (g&lt;sub&gt;A1&lt;/sub&gt;) = -0.408 to -0.903) and in social responsiveness (g&lt;sub&gt;A1&lt;/sub&gt; = -0.427 to -0.521) at T1 and at T2.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;E-Fit is a feasible intervention suggesting EF and social responsiveness improvements in children with cCHD. Motivational strategies to improve adherence to computerised training should be refined before a ","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 5","pages":"e107681"},"PeriodicalIF":2.3,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147855888","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}
引用次数: 0
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