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Azithromycin use in labour to prevent sepsis among pregnant women undergoing vaginal delivery in Nigeria (AZIN-V): a study protocol for a hybrid type 2 effectiveness-implementation trial. 在尼日利亚阴道分娩的孕妇中使用阿奇霉素预防败血症(AZIN-V):一项混合型2有效性实施试验的研究方案。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-06 DOI: 10.1136/bmjopen-2025-110719
Bosede Bukola Afolabi, Christian Chigozie Makwe, Esther Oluwakemi Oluwole, Chisom Obi-Jeff, Eleanor J Mitchell, Aduragbemi Banke-Thomas, Titilope Adenike Adeyemo, Ajibola Ibraheem Abioye, Ejemai Amaize Eboreime, Abdulhadi Diyo Saidu, Udo Abali Okoro, Patricia Akintan, Chioma Stella Osuagwu, Chisom Florence Chieme, Teniola Lawanson, Anower Hossain, Kate Walker
<p><strong>Introduction: </strong>Nigeria has the highest number of maternal deaths globally, and maternal peripartum sepsis is one of the leading causes of maternal mortality. A single oral dose of azithromycin (AZM; 2 g) is safe and effectively reduces 33%-60% of maternal sepsis during planned vaginal birth in low- and middle-income countries (LMICs). However, the clinical and cost-effectiveness of oral AZM during vaginal birth in Nigeria remains unknown in the context of poor antimicrobial stewardship practices, significant antimicrobial resistance and healthcare financing. Evidence is also lacking on the standard care for the prevention of maternal sepsis among pregnant women undergoing vaginal births in Nigeria. The AZIN-V trial is a hybrid type 2 effectiveness-implementation trial to determine the safety, clinical and cost-effectiveness of intrapartum oral AZM versus usual care in the prevention of peripartum maternal sepsis. The trial will also examine the impact of implementation strategies in enhancing adherence to the oral AZM protocol during planned vaginal births and identify effective strategies to improve adherence (fidelity) to the protocol in real-world LMIC settings.</p><p><strong>Methods and analysis: </strong>This is a multicentre hybrid type 2 trial conducted in six Nigerian states: Ebonyi, Edo, Gombe, Kano, Kwara and Lagos. The study aims to simultaneously test the clinical and cost-effectiveness of AZM (clinical trial) and the impact of implementation strategies (implementation research) in Nigeria's unique healthcare context. The clinical trial is a two-arm, cluster-randomised controlled trial conducted across 48 health facilities, randomly assigned (1:1) to either intrapartum administration of oral AZM (intervention group) or usual care-the current routine practice (control group). A total of 5040 study participants (2520 in each group) will be enrolled in the clinical trial. The implementation trial is a two-arm cluster non-randomised controlled trial conducted in 12 health facilities (1:1) allocated to either a bottom-up approach using the Plan-Do-Study-Act cycle or a usual top-down approach with a one-time training workshop and distribution of clinical guidelines, with both arms administering oral AZM during vaginal birth while assessing fidelity (primary outcome).For the clinical trial, data will be analysed using intention-to-treat statistical methods. The cost-effectiveness outcome will be analysed using the Incremental Cost-Effectiveness Ratio. Implementation outcomes will be analysed using descriptive statistics and a thematic approach.</p><p><strong>Ethics and dissemination: </strong>This study has been approved by the National Health Research Ethics Committee, Nigeria (NHREC/01/01/2007-30/09/2024), the ethics committees of the participating health institutions (Lagos University Teaching Hospital Research Ethics Committee: ADM/DSCST/HREC/APP/6325; University of Ilorin Teaching Hospital Health Research Ethics Commi
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引用次数: 0
Deep phenotyping of suicidal ideation after discharge from psychiatric inpatient care: study protocol for an interdisciplinary, multicentre prospective observational study in Psychiatric University Hospitals. 精神科住院病人出院后自杀意念的深度表型:精神科大学医院跨学科、多中心前瞻性观察研究的研究方案
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-06 DOI: 10.1136/bmjopen-2025-111273
Anna Monn, Stephanie Homan, Jacopo Mocellin, Schwarna Maria Raja, Lara Kirchhofer, Vivienne Walser, Eyal Liron Dolev, Marcia Nißen, Tobias Kowatsch, Guido Seiler, Katharina Schultebraucks, Sebastian Olbrich, Birgit Kleim

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

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

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

Trial registration number: CRSII5_205913.

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引用次数: 0
Psychological recovery of nurses after emergencies and disasters: a systematic review protocol. 突发事件和灾害后护士的心理恢复:系统评价方案。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-06 DOI: 10.1136/bmjopen-2025-105202
Yousof Akbari Shahrestanaki, Faranak Sadat Hosseini, Erfaneh Kashiha, Shaghayegh Norouzi, Fatemeh Mirzaei Jirandehi, Mehdi Beyrami Jam

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

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

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

Prospero registration number: CRD420251014914.

{"title":"Psychological recovery of nurses after emergencies and disasters: a systematic review protocol.","authors":"Yousof Akbari Shahrestanaki, Faranak Sadat Hosseini, Erfaneh Kashiha, Shaghayegh Norouzi, Fatemeh Mirzaei Jirandehi, Mehdi Beyrami Jam","doi":"10.1136/bmjopen-2025-105202","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-105202","url":null,"abstract":"<p><strong>Introduction: </strong>With the increasing frequency and intensity of disasters globally-and their profound effects on the mental well-being of healthcare professionals, particularly nurses-the psychological distress experienced by nurses following natural disasters has become a pressing issue. This study aims to explore prevalent patterns and effective interventions for supporting nurses' psychological recovery after disaster exposure, ultimately aiming to propose an optimal recovery model.</p><p><strong>Methods and analysis: </strong>This systematic review will include qualitative, quantitative and mixed-methods studies, as well as relevant systematic reviews, published in English between 2010 and 2025. A comprehensive search will be conducted in PubMed, Web of Science, Scopus and Google Scholar. Study selection, data extraction and quality assessment will be performed independently by multiple reviewers, with methodological quality and risk of bias evaluated using the Mixed Methods Appraisal Tool. Due to anticipated heterogeneity, findings will be synthesised using thematic analysis.</p><p><strong>Ethics and dissemination: </strong>This study protocol raises no ethical issues. The results will be shared through publication in peer-reviewed journals and presentations at appropriate academic conferences.</p><p><strong>Prospero registration number: </strong>CRD420251014914.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 2","pages":"e105202"},"PeriodicalIF":2.3,"publicationDate":"2026-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146131119","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
Perceptions of best practice, pain science and structure-focused education for rotator cuff-related shoulder pain: a content analysis of qualitative data from a randomised experiment. 对肩袖相关肩痛的最佳实践、疼痛科学和以结构为重点的教育的认识:一项随机实验定性数据的内容分析。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-06 DOI: 10.1136/bmjopen-2025-107032
Zixin Zhang, Giovanni E Ferreira, Ryan Muller, Fernando Sousa, Peter Malliaras, Courtney A West, Mary O'Keeffe, Chris Maher, Joshua Zadro

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

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

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

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

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

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

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

{"title":"Perceptions of best practice, pain science and structure-focused education for rotator cuff-related shoulder pain: a content analysis of qualitative data from a randomised experiment.","authors":"Zixin Zhang, Giovanni E Ferreira, Ryan Muller, Fernando Sousa, Peter Malliaras, Courtney A West, Mary O'Keeffe, Chris Maher, Joshua Zadro","doi":"10.1136/bmjopen-2025-107032","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-107032","url":null,"abstract":"<p><strong>Objectives: </strong>To explore how people perceive different forms of education for rotator cuff-related shoulder pain in terms of words or feelings evoked by the education and treatments they feel are needed.</p><p><strong>Setting: </strong>We performed a content analysis of qualitative data collected in a randomised experiment.</p><p><strong>Participants: </strong>2237 participants with rotator cuff-related shoulder pain were randomly assigned to receive three forms of education: <i>best practice education</i>, <i>best practice education plus pain science messages</i> and <i>structure-focused education</i>.</p><p><strong>Primary and secondary outcomes: </strong>After receiving the education, participants answered two questions regarding (1) words or feelings evoked by the education and (2) treatments they felt were needed.</p><p><strong>Results: </strong>2232 responses for each question were analysed (99.7% response rate). Participants who received <i>best practice education</i> more frequently expressed feelings of unhappiness/frustration. The addition of <i>pain science messages</i> to <i>best practice education</i> resulted in slightly more emotional responses and a greater sense of being validated or cared for. In contrast, participants who received <i>structure-focused education</i> more frequently expressed trust in the clinician's expertise and the need for medication, activity modification, rest, diagnostic imaging, injections and surgery. These participants also less frequently considered exercise as a viable treatment option.</p><p><strong>Conclusion: </strong>Participants with rotator cuff-related shoulder pain expressed generally similar emotional responses across groups, with small differences in treatment preferences favouring self-management in the <i>best practice education</i> groups compared with those who received <i>structure-focused education</i>. Those in the <i>best practice education</i> also less frequently reported needing potentially unnecessary treatments (eg, imaging, injections and surgery).</p><p><strong>Trial registration number: </strong>Australia New Zealand Clinical Trials Registry (ACTRN12623000197639).</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 2","pages":"e107032"},"PeriodicalIF":2.3,"publicationDate":"2026-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146131181","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
Patient perspectives on harmonica playing as an intervention for chronic obstructive pulmonary disease: a qualitative study. 口琴演奏作为慢性阻塞性肺疾病干预的病人观点:一项定性研究。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-06 DOI: 10.1136/bmjopen-2025-112115
Wenli Chen, Jingye Huang, Qiuxuan Zeng, Zeng Jie Ye, Junxin Li, Jiaying Li

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

Design: A qualitative study.

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

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

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

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

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

Trial registration number: NCT05995847.

{"title":"Patient perspectives on harmonica playing as an intervention for chronic obstructive pulmonary disease: a qualitative study.","authors":"Wenli Chen, Jingye Huang, Qiuxuan Zeng, Zeng Jie Ye, Junxin Li, Jiaying Li","doi":"10.1136/bmjopen-2025-112115","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-112115","url":null,"abstract":"<p><strong>Objectives: </strong>To qualitatively explore the lived experiences and perceptions of patients with chronic obstructive pulmonary disease (COPD) using the harmonica as a therapeutic intervention.</p><p><strong>Design: </strong>A qualitative study.</p><p><strong>Setting: </strong>The study was conducted at a tertiary hospital in Guangzhou, China.</p><p><strong>Participants: </strong>Patients with COPD who had participated in supervised harmonica playing for at least 12 weeks. (clinical trial registration: NCT05995847).</p><p><strong>Primary and secondary outcome measures: </strong>The study focused on patients' experiences, including perceived facilitators, barriers and needs regarding the intervention.</p><p><strong>Results: </strong>We interviewed 19 patients with COPD between September and December 2024, with interviews lasting an average of 54 min (range: 36-77 min). Five primary themes were identified. Participants reported better physical functioning, including better breathing control, enhanced functional capacity and improved sleep quality. Psychological well-being improved with increased relaxation, emotional improvement and mental engagement. Patients also experienced increased social engagement and role shift, such as expanded social connections, family support and restored family roles. Harmonica playing promoted enhanced self-reliance and personal development, with increased self-management confidence, mastery of the harmonica and encouragement for lifelong learning. Barriers and challenges included physical limitations, breathing difficulties, adherence issues and concerns about the sustainability of long-term benefits.</p><p><strong>Conclusions: </strong>Our study indicates that harmonica playing could improve physical health, psychological well-being, social participation and self-reliance, although barriers persist. Tailored programmes could enhance benefits and adherence, and future research should evaluate durability within comprehensive COPD care.</p><p><strong>Trial registration number: </strong>NCT05995847.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 2","pages":"e112115"},"PeriodicalIF":2.3,"publicationDate":"2026-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146131144","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
Multicentre international observational study on airway management for anaesthesia: the STARGATE study protocol. 麻醉气道管理的多中心国际观察研究:STARGATE研究方案。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-06 DOI: 10.1136/bmjopen-2025-109038
Vincenzo Russotto, Chiara Sansovini, Massimo Muraccini, Francesca Collino, Sheila Nainan Myatra, Andrew Higgs, David Brewster, Renata Curić Radivojević, Matteo Parotto, Kunal Karamchandani, Giovanni Landoni, Massimiliano Sorbello, Mattia Monfroglio, Giulia Rovescala, Pietro Martinelli, Ornella Tinelli, Jennifer Meessen, Giacomo Bellani, John G Laffey, Olivier Langeron, Pietro Caironi

Introduction: More than 300 million major surgical procedures are carried out under general anaesthesia each year worldwide, and advanced airway management remains one of the leading daily challenges for clinicians. Data from large international prospective cohort studies on adverse events such as cardiovascular collapse, cardiac arrest and severe hypoxaemia during advanced airway management to facilitate anaesthesia are lacking.

Methods and analysis: The International obServational sTudy on AiRway manaGement in operAting room and non-operaTing room anaEsthesia (STARGATE) study will be an international prospective observational cohort study describing the incidence of major adverse events associated with advanced airway management (tracheal intubation or supraglottic airway device placement) for general anaesthesia in the operating and non-operating room for surgery and medical procedures. The secondary aim will be to describe the practice of airway management in a large international cohort. Critically ill patients will be excluded from this study. Data on patients' characteristics, type of procedure and the adopted airway management strategy, post-procedure adverse events, operator characteristics and in-hospital mortality will be prospectively collected. The study aims to enrol 10 500 patients.

Ethics and dissemination: The study has been approved by the Ethics Committee of the coordinating centre (Comitato Etico Interaziendale AOU San Luigi Gonzaga, N° 25/2023). Each of the participating centres will then seek approval of their local Ethics Committee before enrolment. Data will be disseminated to the scientific community by original articles submitted to international peer-reviewed journals.

Trial registration number: NCT05759299.

{"title":"Multicentre international observational study on airway management for anaesthesia: the STARGATE study protocol.","authors":"Vincenzo Russotto, Chiara Sansovini, Massimo Muraccini, Francesca Collino, Sheila Nainan Myatra, Andrew Higgs, David Brewster, Renata Curić Radivojević, Matteo Parotto, Kunal Karamchandani, Giovanni Landoni, Massimiliano Sorbello, Mattia Monfroglio, Giulia Rovescala, Pietro Martinelli, Ornella Tinelli, Jennifer Meessen, Giacomo Bellani, John G Laffey, Olivier Langeron, Pietro Caironi","doi":"10.1136/bmjopen-2025-109038","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-109038","url":null,"abstract":"<p><strong>Introduction: </strong>More than 300 million major surgical procedures are carried out under general anaesthesia each year worldwide, and advanced airway management remains one of the leading daily challenges for clinicians. Data from large international prospective cohort studies on adverse events such as cardiovascular collapse, cardiac arrest and severe hypoxaemia during advanced airway management to facilitate anaesthesia are lacking.</p><p><strong>Methods and analysis: </strong>The International ob<b>S</b>ervational s<b>T</b>udy on <b>A</b>i<b>R</b>way mana<b>G</b>ement in oper<b>A</b>ting room and non-opera<b>T</b>ing room ana<b>E</b>sthesia (STARGATE) study will be an international prospective observational cohort study describing the incidence of major adverse events associated with advanced airway management (tracheal intubation or supraglottic airway device placement) for general anaesthesia in the operating and non-operating room for surgery and medical procedures. The secondary aim will be to describe the practice of airway management in a large international cohort. Critically ill patients will be excluded from this study. Data on patients' characteristics, type of procedure and the adopted airway management strategy, post-procedure adverse events, operator characteristics and in-hospital mortality will be prospectively collected. The study aims to enrol 10 500 patients.</p><p><strong>Ethics and dissemination: </strong>The study has been approved by the Ethics Committee of the coordinating centre (Comitato Etico Interaziendale AOU San Luigi Gonzaga, N° 25/2023). Each of the participating centres will then seek approval of their local Ethics Committee before enrolment. Data will be disseminated to the scientific community by original articles submitted to international peer-reviewed journals.</p><p><strong>Trial registration number: </strong>NCT05759299.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 2","pages":"e109038"},"PeriodicalIF":2.3,"publicationDate":"2026-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146131121","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
Perioperative intravenous fluid management in paediatric surgery: a scoping review protocol. 儿科外科围手术期静脉输液管理:范围审查方案
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-06 DOI: 10.1136/bmjopen-2025-112113
Viviana Leidy Sanchez, Valentina Pinzon Rodas, Ginna Cabra-Bautista, Ivan D Florez, Markus Klimek, Jose A Calvache

Introduction: Intravenous fluids are essential components of perioperative care, supporting intravascular volume, acid-base balance and electrolyte homeostasis. Despite extensive research in adult surgical populations, paediatric-specific evidence remains limited, and clinical practice frequently relies on extrapolated adult-based recommendations. This gap is particularly relevant in paediatric non-cardiac surgery, where fluid choice may influence key physiological outcomes such as acid-base status, electrolyte balance, renal function and haemodynamic stability. Given the heterogeneity of study designs, perioperative phases, age groups and reported outcomes in the paediatric literature, a comprehensive synthesis of the existing evidence is needed before a systematic review can be undertaken.

Methods and analysis: We will conduct this scoping review following the methodological guidance of the Joanna Briggs Institute Manual for Evidence Synthesis, and the reporting will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guideline.This scoping review will map existing evidence on perioperative intravenous fluid management in paediatric patients (<18 years) undergoing elective non-cardiac surgery in outpatient and inpatient settings. Eligible study designs will include randomised trials, observational studies and systematic reviews. A comprehensive search will be developed with a medical librarian and applied to MEDLINE (PubMed), Ovid, Embase, Web of Science, CENTRAL, Google Scholar and ClinicalTrials.gov, with no date restrictions and limited to English, Spanish and German.Eligibility is framed using participants, concept and context: paediatric patients (<18 years) undergoing non-cardiac surgery; concepts related to preoperative fasting/replacement period, intraoperative period and postoperative period up to 24 hours, intravenous fluid management for maintenance/replacement; and hospital/outpatient surgical settings. Study selection and data charting will follow established scoping review methodology. Data will be synthesised descriptively using narrative and tabular formats. No meta-analysis or formal risk-of-bias appraisal is planned, consistent with scoping review methodology.

Ethics and dissemination: This scoping review involves no primary data collection and relies exclusively on published literature; therefore, formal ethical approval is not required. The protocol received administrative approval from the Comité de Ética para la Investigación Científica of Universidad del Cauca (approval no. 6553, 11 June 2025). Findings will be disseminated through peer-reviewed publications, conference presentations and targeted communication with paediatric anaesthesia and surgical communities.

{"title":"Perioperative intravenous fluid management in paediatric surgery: a scoping review protocol.","authors":"Viviana Leidy Sanchez, Valentina Pinzon Rodas, Ginna Cabra-Bautista, Ivan D Florez, Markus Klimek, Jose A Calvache","doi":"10.1136/bmjopen-2025-112113","DOIUrl":"10.1136/bmjopen-2025-112113","url":null,"abstract":"<p><strong>Introduction: </strong>Intravenous fluids are essential components of perioperative care, supporting intravascular volume, acid-base balance and electrolyte homeostasis. Despite extensive research in adult surgical populations, paediatric-specific evidence remains limited, and clinical practice frequently relies on extrapolated adult-based recommendations. This gap is particularly relevant in paediatric non-cardiac surgery, where fluid choice may influence key physiological outcomes such as acid-base status, electrolyte balance, renal function and haemodynamic stability. Given the heterogeneity of study designs, perioperative phases, age groups and reported outcomes in the paediatric literature, a comprehensive synthesis of the existing evidence is needed before a systematic review can be undertaken.</p><p><strong>Methods and analysis: </strong>We will conduct this scoping review following the methodological guidance of the Joanna Briggs Institute Manual for Evidence Synthesis, and the reporting will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guideline.This scoping review will map existing evidence on perioperative intravenous fluid management in paediatric patients (<18 years) undergoing elective non-cardiac surgery in outpatient and inpatient settings. Eligible study designs will include randomised trials, observational studies and systematic reviews. A comprehensive search will be developed with a medical librarian and applied to MEDLINE (PubMed), Ovid, Embase, Web of Science, CENTRAL, Google Scholar and ClinicalTrials.gov, with no date restrictions and limited to English, Spanish and German.Eligibility is framed using participants, concept and context: paediatric patients (<18 years) undergoing non-cardiac surgery; concepts related to preoperative fasting/replacement period, intraoperative period and postoperative period up to 24 hours, intravenous fluid management for maintenance/replacement; and hospital/outpatient surgical settings. Study selection and data charting will follow established scoping review methodology. Data will be synthesised descriptively using narrative and tabular formats. No meta-analysis or formal risk-of-bias appraisal is planned, consistent with scoping review methodology.</p><p><strong>Ethics and dissemination: </strong>This scoping review involves no primary data collection and relies exclusively on published literature; therefore, formal ethical approval is not required. The protocol received administrative approval from the Comité de Ética para la Investigación Científica of Universidad del Cauca (approval no. 6553, 11 June 2025). Findings will be disseminated through peer-reviewed publications, conference presentations and targeted communication with paediatric anaesthesia and surgical communities.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 2","pages":"e112113"},"PeriodicalIF":2.3,"publicationDate":"2026-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146131168","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
HIV diagnostic implementation in the Dominican Republic: an in-depth qualitative context analysis for health technology developers. 多米尼加共和国的艾滋病毒诊断实施:卫生技术开发人员的深入定性背景分析。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-06 DOI: 10.1136/bmjopen-2024-096338
Kiara Lee, David Arango, Shamill Morel, Karla Sterling, Madina Agénor, Anubhav Tripathi, Claudia Rodriguez, Rochelle Rosen, Martha Sanchez

Objectives: To understand the political, economic, social and technological facilitators and barriers in obtaining an HIV diagnosis to inform implementation strategies for HIV diagnostics in the Dominican Republic (DR).

Design: In-depth, semi-structured qualitative interviews.

Setting: A high complexity public hospital in Santiago de los Caballeros, DR.

Participants: A convenience and purposive sample of 36 internal medicine physicians and laboratory personnel involved in sample collection, sample analysis or oversight of biological sample analysis.

Results: Using the Social Ecological Model, our results highlighted several interrelated barriers and facilitators to sample analysis at the individual (patient), interpersonal (interactions between laboratory personnel, physicians and patients), organisational (the hospital), community (Santiago de Los Caballeros) and societal (the DR) levels. Some key findings include the importance of psychological support in receiving an HIV diagnosis, how spoken language can be a barrier to care, how inconsistent access to laboratory supplies is a barrier for patients, laboratory personnel and clinicians, and the importance of government public health investment.

Conclusions: Employing qualitative methods to investigate a bioengineering challenge yielded rich data on the sociotechnical implementation context of HIV diagnostics in the DR. Several context-relevant suggestions were developed for HIV diagnostic developers which include incorporating psychological support into the diagnosis workflow, delivering information in multiple languages (ie, Haitian Creole and Spanish) and with non-stigmatising phrasing, working with the public sector to develop and implement technologies, and reducing the supply chain reliance on high-income countries to lessen delays in care. These findings can apply to other types of health technologies and settings and demonstrate the importance of utilizing human-centered design to understand implementation context and promote global health equity in health technology development and adoption.

{"title":"HIV diagnostic implementation in the Dominican Republic: an in-depth qualitative context analysis for health technology developers.","authors":"Kiara Lee, David Arango, Shamill Morel, Karla Sterling, Madina Agénor, Anubhav Tripathi, Claudia Rodriguez, Rochelle Rosen, Martha Sanchez","doi":"10.1136/bmjopen-2024-096338","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-096338","url":null,"abstract":"<p><strong>Objectives: </strong>To understand the political, economic, social and technological facilitators and barriers in obtaining an HIV diagnosis to inform implementation strategies for HIV diagnostics in the Dominican Republic (DR).</p><p><strong>Design: </strong>In-depth, semi-structured qualitative interviews.</p><p><strong>Setting: </strong>A high complexity public hospital in Santiago de los Caballeros, DR.</p><p><strong>Participants: </strong>A convenience and purposive sample of 36 internal medicine physicians and laboratory personnel involved in sample collection, sample analysis or oversight of biological sample analysis.</p><p><strong>Results: </strong>Using the Social Ecological Model, our results highlighted several interrelated barriers and facilitators to sample analysis at the individual (patient), interpersonal (interactions between laboratory personnel, physicians and patients), organisational (the hospital), community (Santiago de Los Caballeros) and societal (the DR) levels. Some key findings include the importance of psychological support in receiving an HIV diagnosis, how spoken language can be a barrier to care, how inconsistent access to laboratory supplies is a barrier for patients, laboratory personnel and clinicians, and the importance of government public health investment.</p><p><strong>Conclusions: </strong>Employing qualitative methods to investigate a bioengineering challenge yielded rich data on the sociotechnical implementation context of HIV diagnostics in the DR. Several context-relevant suggestions were developed for HIV diagnostic developers which include incorporating psychological support into the diagnosis workflow, delivering information in multiple languages (ie, Haitian Creole and Spanish) and with non-stigmatising phrasing, working with the public sector to develop and implement technologies, and reducing the supply chain reliance on high-income countries to lessen delays in care. These findings can apply to other types of health technologies and settings and demonstrate the importance of utilizing human-centered design to understand implementation context and promote global health equity in health technology development and adoption.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 2","pages":"e096338"},"PeriodicalIF":2.3,"publicationDate":"2026-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146130999","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
Development of a resilience assessment tool for cardiac care pathways in Europe: a mixed-methods study. 欧洲心脏护理途径弹性评估工具的发展:一项混合方法研究。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-06 DOI: 10.1136/bmjopen-2025-110266
Ana Sofia V Carvalho, Óscar Brito Fernandes, Jan J Piek, Josepa Mauri, Ariadna Sanz Escartin, William Wijns, Niek Klazinga, Dionne Kringos

Objectives: To develop a resilience assessment tool for cardiac care pathways in Europe, informed by stakeholder insights on the impact of COVID-19, emerging innovations and recommendations to enhance resilience.

Design: Mixed-methods study comprising three phases: (1) survey among European cardiac care providers; (2) five multistakeholder focus groups and (3) participatory tool development. Quantitative data were analysed using descriptive statistics, and qualitative data were analysed thematically.

Setting: The survey targeted cardiology professionals from the 27 European Union Member States and Ukraine who worked during the COVID-19 pandemic. Focus group participants were purposefully sampled to represent clinical, organisational and policy perspectives.

Participants: A total of 177 survey respondents and 40 informants in focus groups.

Results: Six key resilience dimensions of cardiac care pathways were identified: workforce, organisation of care delivery, governance and trust, communication and cooperation, medical devices and products, and data collection and use. Staff shortages and infrastructure capacity were key challenges during the pandemic. The most frequent measures were the reallocation of health staff (75%; n=133) and repurposing infrastructures (38%; n=32). Participants discussed the six resilience dimensions around a total of 17 subdimensions and 39 recommended actions to enhance resilience were identified. The resulting resilience assessment tool included four components: (1) mapping a context-specific cardiac care pathway; (2) stakeholder identification critical to participate in collective self-assessment; (3) a preparedness checklist generating a visual heat map and (4) a resource toolkit.

Conclusions: The resilience assessment tool offers step-by-step guidance to strengthening cardiac care pathways across six key resilience dimensions, supported by actionable recommendations. The tool enables the identification of context-specific vulnerabilities and improvement priorities, thereby supporting healthcare professionals and policymakers in enhancing preparedness and ensuring care continuity before, during and after crises. Its implementation is currently being piloted in European hospitals to evaluate and refine its practical applicability.

{"title":"Development of a resilience assessment tool for cardiac care pathways in Europe: a mixed-methods study.","authors":"Ana Sofia V Carvalho, Óscar Brito Fernandes, Jan J Piek, Josepa Mauri, Ariadna Sanz Escartin, William Wijns, Niek Klazinga, Dionne Kringos","doi":"10.1136/bmjopen-2025-110266","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-110266","url":null,"abstract":"<p><strong>Objectives: </strong>To develop a resilience assessment tool for cardiac care pathways in Europe, informed by stakeholder insights on the impact of COVID-19, emerging innovations and recommendations to enhance resilience.</p><p><strong>Design: </strong>Mixed-methods study comprising three phases: (1) survey among European cardiac care providers; (2) five multistakeholder focus groups and (3) participatory tool development. Quantitative data were analysed using descriptive statistics, and qualitative data were analysed thematically.</p><p><strong>Setting: </strong>The survey targeted cardiology professionals from the 27 European Union Member States and Ukraine who worked during the COVID-19 pandemic. Focus group participants were purposefully sampled to represent clinical, organisational and policy perspectives.</p><p><strong>Participants: </strong>A total of 177 survey respondents and 40 informants in focus groups.</p><p><strong>Results: </strong>Six key resilience dimensions of cardiac care pathways were identified: workforce, organisation of care delivery, governance and trust, communication and cooperation, medical devices and products, and data collection and use. Staff shortages and infrastructure capacity were key challenges during the pandemic. The most frequent measures were the reallocation of health staff (75%; n=133) and repurposing infrastructures (38%; n=32). Participants discussed the six resilience dimensions around a total of 17 subdimensions and 39 recommended actions to enhance resilience were identified. The resulting resilience assessment tool included four components: (1) mapping a context-specific cardiac care pathway; (2) stakeholder identification critical to participate in collective self-assessment; (3) a preparedness checklist generating a visual heat map and (4) a resource toolkit.</p><p><strong>Conclusions: </strong>The resilience assessment tool offers step-by-step guidance to strengthening cardiac care pathways across six key resilience dimensions, supported by actionable recommendations. The tool enables the identification of context-specific vulnerabilities and improvement priorities, thereby supporting healthcare professionals and policymakers in enhancing preparedness and ensuring care continuity before, during and after crises. Its implementation is currently being piloted in European hospitals to evaluate and refine its practical applicability.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 2","pages":"e110266"},"PeriodicalIF":2.3,"publicationDate":"2026-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146131055","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
Exploring the impact of targeted exercise in women experiencing homelessness, addiction and mental health challenges: a mixed-methods feasibility study. 探索有针对性的锻炼对经历无家可归、成瘾和精神健康挑战的妇女的影响:一项混合方法可行性研究。
IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2026-02-06 DOI: 10.1136/bmjopen-2025-103060
Fiona Kennedy, Deirdre Murray, Clíona Ní Cheallaigh, Roman Romero-Ortuno, Sinéad Gavin, Julie Broderick

Objective: Low physical functioning and frailty are prevalent in non-geriatric vulnerable populations such as people experiencing homelessness, addiction and mental health challenges. The objective of this study was to explore the feasibility and impact of a targeted exercise intervention with protein supplementation for women experiencing homelessness, addiction and mental health challenges.

Design: Mixed-methods feasibility study.

Setting: A women's-only day service for people with homelessness and addiction issues, in Dublin, Ireland.

Participants: Women experiencing homelessness, addiction and mental health challenges.

Interventions: The intervention was a 10-week low-threshold exercise and protein supplementation pre-post programme (LEAP-W). Qualitative interviews were conducted following the intervention with programme participants and key stakeholders.

Primary and secondary outcome measures: The primary outcome was feasibility measured by recruitment, retention, adherence, safety and acceptability, and secondary outcomes measured pre-post intervention change in physical function, pain, nutritional and frailty status, and overall health status.

Results: Overall, 33 participants were recruited. Data generated demonstrated that LEAP-W was feasible by its safety, acceptability and high retention in certain subgroups, and high adherence to the exercise and protein supplement; its impact was demonstrated by pre-post intervention improvement in multiple domains (strength (chair stand test), balance (the single leg stance test), pain and quality of life/mental health (mental component summary of the Short Form-12; 95% CI, p<0.05)). Three themes emerged from the qualitative inquiry: (1) the power of exercise; (2) challenges to engagement and (3) the LEAP approach, driven by the trauma-informed and low threshold approach.

Conclusion: Targeted exercise interventions with trauma-sensitive, flexible design can be successfully delivered and yield impact in women with complex needs who experience homelessness, addiction and mental health challenges. Service design should be considered when delivering interventions to this population. Further higher-powered longitudinal studies are warranted.

Trial registration number: NCT06264895.

{"title":"Exploring the impact of targeted exercise in women experiencing homelessness, addiction and mental health challenges: a mixed-methods feasibility study.","authors":"Fiona Kennedy, Deirdre Murray, Clíona Ní Cheallaigh, Roman Romero-Ortuno, Sinéad Gavin, Julie Broderick","doi":"10.1136/bmjopen-2025-103060","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-103060","url":null,"abstract":"<p><strong>Objective: </strong>Low physical functioning and frailty are prevalent in non-geriatric vulnerable populations such as people experiencing homelessness, addiction and mental health challenges. The objective of this study was to explore the feasibility and impact of a targeted exercise intervention with protein supplementation for women experiencing homelessness, addiction and mental health challenges.</p><p><strong>Design: </strong>Mixed-methods feasibility study.</p><p><strong>Setting: </strong>A women's-only day service for people with homelessness and addiction issues, in Dublin, Ireland.</p><p><strong>Participants: </strong>Women experiencing homelessness, addiction and mental health challenges.</p><p><strong>Interventions: </strong>The intervention was a 10-week <i>low-threshold exercise and protein</i> supplementation pre-post programme (LEAP-W). Qualitative interviews were conducted following the intervention with programme participants and key stakeholders.</p><p><strong>Primary and secondary outcome measures: </strong>The primary outcome was feasibility measured by recruitment, retention, adherence, safety and acceptability, and secondary outcomes measured pre-post intervention change in physical function, pain, nutritional and frailty status, and overall health status.</p><p><strong>Results: </strong>Overall, 33 participants were recruited. Data generated demonstrated that LEAP-W was feasible by its safety, acceptability and high retention in certain subgroups, and high adherence to the exercise and protein supplement; its impact was demonstrated by pre-post intervention improvement in multiple domains (strength (chair stand test), balance (the single leg stance test), pain and quality of life/mental health (mental component summary of the Short Form-12; 95% CI, p<0.05)). Three themes emerged from the qualitative inquiry: (1) the power of exercise; (2) challenges to engagement and (3) the LEAP approach, driven by the trauma-informed and low threshold approach.</p><p><strong>Conclusion: </strong>Targeted exercise interventions with trauma-sensitive, flexible design can be successfully delivered and yield impact in women with complex needs who experience homelessness, addiction and mental health challenges. Service design should be considered when delivering interventions to this population. Further higher-powered longitudinal studies are warranted.</p><p><strong>Trial registration number: </strong>NCT06264895.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"16 2","pages":"e103060"},"PeriodicalIF":2.3,"publicationDate":"2026-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146131061","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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