BMJ Open最新文献

{"title":"Poor clinical outcome despite successful recanalisation in patients with acute myocardial infarction undergoing direct percutaneous coronary intervention: a retrospective cohort study.","authors":"Xiaodong Pan, Wei Du, Zeyan Liu","doi":"10.1136/bmjopen-2024-097434","DOIUrl":"10.1136/bmjopen-2024-097434","url":null,"abstract":"<p><strong>Background: </strong>ST-segment elevation myocardial infarction (STEMI) remains a major cause of morbidity and mortality. Primary percutaneous coronary intervention (PPCI) is the preferred treatment, yet some patients experience major adverse cardiac events (MACE) within a year despite successful recanalisation. Identifying predictors of futile recanalisation-defined as achieving thrombolysis in myocardial infarction grade III flow after PPCI but still developing MACE-is essential for improving outcomes.</p><p><strong>Research design and methods: </strong>This single-centre, retrospective study included patients with STEMI treated with PPCI from January 2019 to January 2023. The primary outcome was futile recanalisation. Least absolute shrinkage and selection operator (LASSO) regression and logistic regression were used to identify independent predictors of futile recanalisation.</p><p><strong>Results: </strong>Of the 489 consecutive patients who achieved successful recanalisation, 20.9% met the criteria for futile recanalisation within 1 year. Multivariable analysis identified several independent predictors: heart rate at admission (OR 1.32, 95% CI 1.02 to 1.71), reduced left ventricular ejection fraction (LVEF; OR 0.30, 95% CI 0.22 to 0.41), advanced left ventricular diastolic dysfunction (OR 1.44, 95% CI 1.02 to 2.15), elevated cardiac troponin I (CTnI) levels (OR 1.42, 95% CI 1.08 to 1.90), high Selvester QRS scores (OR 1.59, 95% CI 1.20 to 2.13) and increased homocysteine (HCY) levels (OR 1.37, 95% CI 1.07 to 1.77).</p><p><strong>Conclusion: </strong>Despite successful recanalisation, certain factors-high admission heart rate, low LVEF, advanced left ventricular diastolic dysfunction, elevated CTnI levels, high Selvester QRS scores, and increased HCY levels-are associated with futile recanalisation in patients with STEMI. These findings highlight the need for targeted monitoring and management strategies to reduce long-term MACE risks in this population.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e097434"},"PeriodicalIF":2.4,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11938233/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143708417","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":"Collaboration between local authorities and civil society organisations for improving health: a scoping review.","authors":"Annika Bäck, Michaela Modin Asper, Stephanie Madsen, Leif Eriksson, Veronica Aurelia Costea, Henna Hasson, Anna Bergström","doi":"10.1136/bmjopen-2024-092525","DOIUrl":"10.1136/bmjopen-2024-092525","url":null,"abstract":"<p><strong>Objectives: </strong>Cross-sector collaboration has been encouraged to improve population health. Both local authorities and civil society organisations impact population health, but less is known about <i>how</i> the actual process of collaboration is done. This scoping review aims to explore how local authorities and civil society organisations collaborate with the ambition to improve population health.</p><p><strong>Design: </strong>This scoping review was informed by the guidance of the Joanna Briggs Institute, and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews.</p><p><strong>Data sources: </strong>Medline, Web of Science, CINAHL and Sociological Abstracts were searched from inception to September 2022.</p><p><strong>Eligibility criteria: </strong>We included peer-reviewed empirical studies that describe the initiation, execution or sustainment of collaboration for health between local authorities and civil society organisations.</p><p><strong>Data extraction and synthesis: </strong>Two independent reviewers extracted data, which was summarised and analysed using inductive content analysis.</p><p><strong>Results: </strong>In the 79 included articles, collaborations between local authorities and civil society organisations entailed many different aspects, from exchanging knowledge, allocating resources, providing different types of support or human resources, training, forming different working groups, agreements and working plans to gathering data for needs analysis or evaluation. Few articles described how the collaboration had been initiated or sustained. Initiation was done through advocacy, needs assessments, making a request, creating a workgroup and conducting a pilot study. Sustainment efforts were continuous meetings, documents and tools, funding, and different plans and work structures. There were often additional actors involved in the collaborations. Information about study design was often not described in a clear and comparative manner.</p><p><strong>Conclusions: </strong>There is a need for more research on the details of initiating, executing and sustaining collaborations for health between local authorities and civil society organisations. Knowledge from this scoping review can be used to inform the planning of future collaborations between local authorities and civil society organisations.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e092525"},"PeriodicalIF":2.4,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11938224/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143708513","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":"Open-label placebo for non-specific pain in the emergency department (OLP EM): study protocol for a mixed-method randomised control feasibility study in Switzerland.","authors":"Bojana Degen, Anna Szczesna, Christian H Nickel, Roland Bingisser, Jens Gaab, Bruno Minotti","doi":"10.1136/bmjopen-2024-090508","DOIUrl":"10.1136/bmjopen-2024-090508","url":null,"abstract":"<p><strong>Introduction: </strong>Non-specific pain (NSP), defined as pain without a clear pathological cause, is a common presentation in the emergency department (ED). There is no universally accepted analgesic strategy, but non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen are often prescribed. However, the established efficacy of NSAIDs for NSP is limited. Additionally, NSAIDs are associated with an increased risk of upper gastrointestinal bleeding, acute kidney injury and cardiovascular events, such as myocardial infarction and stroke. There is increasing evidence supporting the analgesic effects of open-label placebo (OLP), defined as placebo administered to patients without deception, in a broad variety of settings. Accordingly, OLP could be a safer, effective analgesic treatment option for NSP. To our knowledge, this is the first study investigating the feasibility of OLP for NSP in the ED. Therefore, our primary objective is to assess whether OLP is a feasible treatment option in this setting.</p><p><strong>Methods and analysis: </strong>Patients diagnosed with acute NSP will be prospectively recruited at discharge in the ED at the University Hospital of Basel, Switzerland. Patients treated with pain medication for >7 days prior to ED visit or with chronic pain will be excluded. Patients will be randomised to receive either OLP (intervention) or ibuprofen (control). Rescue medication will be ibuprofen in both groups. Daily online self-assessment will take place during the first 7 days after the baseline visit as well as on day 30. A qualitative interview will be conducted on day 30. The primary outcome is feasibility, consisting of acceptability, adherence to the protocol and patient satisfaction. Clinical outcomes will focus on pain intensity and interference according to the Brief Pain Inventory Short Form as well as adverse events.</p><p><strong>Ethics and dissemination: </strong>The study protocol has received approval from the ethics committee for Northwestern and central Switzerland (EKNZ; project ID 2024-00089). The results will be disseminated in peer-reviewed journals and at scientific conferences.</p><p><strong>Trial registration number: </strong>Swiss National Clinical Trials Portal (SNCTP000005852); Clinicaltrial.gov (NCT06408519).</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e090508"},"PeriodicalIF":2.4,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11938250/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143708411","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":"Optimal cut-off points for waist circumference in the definition of metabolic syndrome: a cross-sectional study in rural Bangladesh.","authors":"Tasnima Siddiquee, Bishwajit Bhowmik, Sanjida Binte Munir, Hafiza Nasrin, Nayla Cristina Do Vale Moreira, Sharif Mahmood, Tanjimul Islam, Fahmida Mahmud, Iasmin Haque, Shamim Khan, Hajera Mahtab, A K Azad Khan","doi":"10.1136/bmjopen-2024-093159","DOIUrl":"10.1136/bmjopen-2024-093159","url":null,"abstract":"<p><strong>Objective: </strong>To determine optimal waist circumference (WC) cut-off points for identifying metabolic syndrome (MetS) in Bangladeshi adults, with the aim of enhancing diagnostic accuracy specific to this population.</p><p><strong>Design: </strong>Cross-sectional analysis.</p><p><strong>Setting: </strong>Rural community in Chandra, Bangladesh.</p><p><strong>Participants: </strong>A total of 2293 adults aged 20 years and older.</p><p><strong>Primary and secondary outcome measures: </strong>MetS was defined using the modified National Cholesterol Education Program Adult Treatment Panel III criteria. Receiver operating characteristic (ROC) curves and Youden's Index were used to identify WC cut-off points that maximised sensitivity and specificity for diagnosing MetS. Restricted cubic spline regression was employed to explore the non-linear relationship between WC and MetS risk.</p><p><strong>Results: </strong>The optimal WC cut-off points for predicting MetS were 90 cm for men (sensitivity 55.2%, specificity 94.3%, OR 12.5, 95% CI 8.6 to 18.0) and 80 cm for women (sensitivity 86.7%, specificity 71.9%, OR 15.6, 95% CI 11.4 to 21.3). The area under the ROC curve was 0.819 for men and 0.827 for women. Non-linear analysis indicated a significant increase in MetS risk beyond these thresholds, with a steeper risk gradient observed in men.</p><p><strong>Conclusions: </strong>This study establishes WC cut-off points of 90 cm for men and 80 cm for women as optimal for diagnosing MetS in Bangladeshi adults, underscoring the necessity of population-specific diagnostic criteria to improve early detection and management.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e093159"},"PeriodicalIF":2.4,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11938217/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143708414","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":"Assessing the prevalence, quality and compliance of data-sharing statements in gastroenterology publications: a cross-sectional analysis.","authors":"Jacksen Moore, Khanh Nguyen, Brody Dennis, Mahad Chaudhry, Annes Elfar, Eli Oldham, Eli Paul, Jacob Cohn, Alicia Ito Ford, Matthew Vassar","doi":"10.1136/bmjopen-2024-092490","DOIUrl":"10.1136/bmjopen-2024-092490","url":null,"abstract":"<p><strong>Objective: </strong>To examine the current state of data-sharing practices in gastroenterology literature, focusing on data-sharing statements (DSS) and identifying influential factors on DSS inclusion.</p><p><strong>Background: </strong>High-quality, reproducible research is crucial in addressing the widespread prevalence of gastrointestinal diseases. Data-sharing practices enable researchers to access studies more easily, enhancing reproducibility. Our study aims to analyse the inclusion and influence of DSS in top gastroenterology journals.</p><p><strong>Methods: </strong>We conducted a cross-sectional analysis to examine the use and contents of DSS in gastroenterology clinical trials. Using Clarivate's Journal Citation Reports, we selected five leading gastroenterology journals. Then, we searched MEDLINE (PubMed) for original research articles published between 1 January 2018 and 31 December 2023. In a double-blind, duplicate manner, data were extracted on DSS presence, funding source, study design and open-access status. We then conducted a thematic analysis of all DSS. Additionally, authors were contacted and given 14 days to respond or share data to investigate adherence to their DSS.</p><p><strong>Results: </strong>Of the 953 articles that met inclusion criteria, 400 (400/953; 42.0%) contained a DSS. Open-access articles had a higher likelihood of containing DSS (estimate=0·413; p<0.05). <i>The Lancet Gastroenterology and Hepatology</i> has the highest percentage of DSS (159/194; 82.0%), while <i>Clinical Gastroenterology and Hepatology</i> has the lowest percentage of DSS (33/256; 12.9%). Impact factor is a significant indicator for DSS (estimate=0.138, p=0.01). Finally, 'conditional data availability' was the most common data theme in our study (225/303; 74.3%). Over half (153/284; 53.9%) of the authors contacted did not respond to our request for sharing data.</p><p><strong>Conclusion: </strong>Our findings reveal significant variability in DSS inclusion and adherence among top gastroenterology journals. Journals with mandatory data-sharing policies demonstrated higher compliance, while open-access status and journal impact factor were positively associated with data-sharing practices. However, a notable gap remains in authors' follow-through on stated data-sharing commitments.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e092490"},"PeriodicalIF":2.4,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11938244/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143708431","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":"Selection of indirect treatment comparisons for health technology assessments: a practical guide for health economics and outcomes research scientists and clinicians.","authors":"Jennifer D Guo, Adel Gehchan, Abraham Hartzema","doi":"10.1136/bmjopen-2024-091961","DOIUrl":"10.1136/bmjopen-2024-091961","url":null,"abstract":"<p><strong>Background: </strong>Health technology assessment (HTA) bodies evaluate the clinical and economic values of health interventions to inform healthcare decision-making. They face the challenge of lacking head-to-head randomised clinical trial data against the standard of care. Indirect treatment comparison (ITC) methods are often used and accepted by HTA bodies worldwide, but there are numerous options with various and inconsistent terminologies. The selection and application of ITC methods are complex from methodological and clinical perspectives.</p><p><strong>Objectives: </strong>This article (1) provides a comprehensive overview of ITC methods by clarifying used terminologies, including fundamental assumptions, frameworks, strengths, limitations, applications and specific considerations; (2) examines recent ITC guidelines with recommendations or preferences from major HTA bodies and (3) guides health economics and outcomes research (HEOR) scientists and clinicians in the strategic selection of ITC methods with case examples.</p><p><strong>Methods: </strong>The authors conducted a rapid review to identify the literature related to ITC methods and ITC-relevant HTA guidelines in various databases between 2009 and April 2024.</p><p><strong>Conclusions: </strong>Comprehensive knowledge of the ITC methods landscape and the evolving ITC-relevant HTA guidelines are essential for ITC methods selection. Effective communication/collaboration between HEOR scientists and clinicians ensures that the selection and justification of ITC methods are robust for HTA submissions.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e091961"},"PeriodicalIF":2.4,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11938225/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143708578","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":"'They don't squeal, 'Disabled'.': using qualitative interviews to explore user perceptions of 'stylish' grab rails intended to promote healthy ageing in place in England.","authors":"Sarah Dickson, Kate Gibson, Mitra Cheraghi, Andrew Kingston, Katie Brittain","doi":"10.1136/bmjopen-2024-093698","DOIUrl":"10.1136/bmjopen-2024-093698","url":null,"abstract":"<p><strong>Objectives: </strong>This qualitative study seeks to answer the question: How do older adults use and perceive home adaptations, specifically grab rails designed to blend into the home environment and avoid overt associations with disability? The grab rails were provided by a large energy company. They were specifically designed to be discreet, stylish and have a dual purpose, with the aim of supporting healthy ageing through ageing in place.</p><p><strong>Design: </strong>A qualitative study using semistructured interviews, with thematic analysis.</p><p><strong>Setting: </strong>Interviews were conducted predominantly via telephone calls, between 5 June 2023 and 14 August 2023.</p><p><strong>Participants: </strong>33 participants took part in the study with a mean age of 64.2 years. Participants resided in the following regions across the UK: North East, North West, Yorkshire, East and West Midlands. Purposive sampling allowed diversity in gender, ethnicity and home tenure. The grab rails were installed at least 3 months prior to recruitment.</p><p><strong>Results: </strong>Many participants reported that using the grab rails helped their independence and safety in daily life. The aesthetics of the grab rails were positively appraised, specifically because they had a notably different outward appearance to standard grab rails. Participants were aware that declining mobility can be stigmatising, and they felt the grab rails mitigated this by being discreet and enabling them to present a home which they felt would be accepted by wider society. Participants felt this protected their identity, as they wanted to appear independent to wider society. However, some participants were unaware that the grab rails had been designed with a duality of purpose or were apprehensive towards the functionality of these grab rails. This apprehension may have stemmed from the home adaptations being provided by a large energy provider, or because the discreet design of the grab rails made their intended purpose less overt.</p><p><strong>Conclusions: </strong>While home adaptations with a discreet and stylish aesthetic are valued by older people, our findings highlight that there are issues with commodifying home adaptations. Furthermore, we demonstrate the importance of addressing the social stigma associated with ageing-related home adaptations.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e093698"},"PeriodicalIF":2.4,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11938234/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143708645","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":"Research waste in randomised trials of exercise treatments for chronic low back pain: trial sequential and cumulative meta-analyses by publication date and size.","authors":"Flora Chamberlain, Louise Elliott, Amin Yarahmadi, Martin Underwood","doi":"10.1136/bmjopen-2024-087787","DOIUrl":"10.1136/bmjopen-2024-087787","url":null,"abstract":"<p><strong>Objective: </strong>To determine if there is research waste in controlled trials of exercise therapies compared with usual care/no treatment for adults with chronic non-specific lower back pain.</p><p><strong>Design and data sources: </strong>Secondary analysis of previously published systematic review (Cochrane review).</p><p><strong>Eligibility criteria: </strong>Randomised controlled trials comparing exercise treatments for chronic low back pain to usual care/no treatment eligible for inclusion in the 2021 Cochrane review of exercise interventions for chronic low back pain.</p><p><strong>Data extraction and synthesis: </strong>All data were taken from the 2021 Cochrane review of exercise therapy for chronic lower back pain and the UK BEAM trial. We did trial-sequential meta-analysis and cumulative meta-analyses, exploring changes in effect estimates over time and by trial size.</p><p><strong>Results: </strong>Respective superiority boundaries for pain and disability were crossed in 2004 after four and five trials (n=358/415) were published. A further 43 trials with 2626 participants were included in the Cochrane review. In 2004, the mean effect sizes for pain and disability were -12.85 (95% CI -24.89 to -0.81) and -6.67 (95% CI -11.27 to 3.36), respectively; similar to those reported by Cochrane in 2021. Including small trials substantially affected effect size estimates. When the 33 and 36 trials, respectively, with fewer than 70 participants are excluded, the limits of the 95% CIs for effect size estimates exclude the clinically important differences ((pain; -8.8 (95% CI -11.38 to -5.63): disability -4.27 (95% CI -6.12 to -2.24).</p><p><strong>Conclusions: </strong>It may be difficult to justify any further trials comparing exercise interventions to usual care/no treatment for chronic low back pain. The inclusion of small studies in meta-analyses has produced biased results in previous meta-analyses. Exercise treatments might not have a clinically important effect on people with chronic low back pain.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e087787"},"PeriodicalIF":2.4,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11938220/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143708539","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 norepinephrine versus phenylephrine on brain circulation, organ blood flow and tissue oxygenation in anaesthetised patients with brain tumours: study protocol for a randomised controlled trial.","authors":"Niwar Faisal Mohamad, Klaus Ulrik Koch, Joel Aanerud, Kaare Meier, Irene Klærke Mikkelsen, Ulrick S Espelund, Christian Fenger Eriksen, Niels Juul, Karen Baden Alstrup, Bo Jespersen, Lene Marie Fries, Alp Tankisi, Stig Dyrskog, Søren Ole Stigaard Cortnum, Ann Katrine Sindby, Per Borghammer, Lars Poulsen Tolbod, LingZhong Meng, Anders Rosendal Korshoej, Mads Rasmussen","doi":"10.1136/bmjopen-2024-095172","DOIUrl":"10.1136/bmjopen-2024-095172","url":null,"abstract":"<p><strong>Introduction: </strong>Vasopressor support is often preferred as an efficient and convenient way to raise the blood pressure during surgery and intensive care therapy. However, the optimal vasopressor for ensuring organ blood flow and tissue oxygen delivery during surgery remains undetermined. This study aims to assess the impact of norepinephrine versus phenylephrine on cerebral and non-cerebral organ perfusion and oxygenation during anaesthesia in neurosurgical patients with brain tumours. The study also explores the impact of the vasopressor agents on the distribution of cardiac output between various organs.</p><p><strong>Methods and analysis: </strong>This is an investigator-initiated, double-blinded, randomised clinical trial including 32 patients scheduled for supratentorial brain tumour surgery. The patients are randomised to receive a phenylephrine or norepinephrine infusion during preoperative positron emission tomography (PET) examinations and the following neurosurgical procedure. PET measurements of blood flow and oxygen metabolism in the brain and other organs are performed on the awake subject during anaesthesia, following a 10% and 20% gradual increase in blood pressure from the baseline value. The primary endpoint is the between-group difference in cerebral blood flow. Secondary endpoints include detection of ischaemic brain lesions possibly associated with vasopressor treatment, changes in cerebral oxygen metabolism, non-cerebral organ blood flow and oxygen metabolism, cardiac output, regional cerebral oxygen saturation, autoregulation and distribution of cardiac output between organs.</p><p><strong>Ethics and dissemination: </strong>This study was approved by the Danish National Medical Ethics Committee (20 May 2022; 2203674). Results will be disseminated via peer-reviewed publication and presentation at international conferences.</p><p><strong>Trial registration number: </strong>EudraCT no: 2021-006168-26.</p><p><strong>Clinicaltrials: </strong>gov: NCT06083948.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e095172"},"PeriodicalIF":2.4,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11938255/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143708051","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":"Development and cross-validation of a short questionnaire to evaluate self-reported positive health: a cross-sectional panel study of structural validity among a general Dutch population.","authors":"Lenny M W Nahar-van Venrooij, Margot J Metz, Marja van Vliet, Vera P van Druten, Babette C van der Zwaard","doi":"10.1136/bmjopen-2024-091377","DOIUrl":"10.1136/bmjopen-2024-091377","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to further develop and cross-validate a short questionnaire to measure self-reported Positive Health in general (Dutch) populations for evaluative purposes, stemming from the original 42 items of the My Positive Health (MPH) dialogue tool. Positive Health refers to 'health from the perspective of patients and citizens' following the concept of Huber <i>et al</i>.</p><p><strong>Design and setting: </strong>A cross-sectional study was performed among a panel representative for the general adult Dutch population living at home.</p><p><strong>Participants: </strong>The response rate was 76%, 1327 of a total of 2457 respondents were female, and mean age (years) was 53.3±17.8.</p><p><strong>Methods: </strong>First, item reduction was carried out through content discussions following statistical output retrieved from factor structures and loadings, inter-item correlations and internal consistency (Cronbach's alpha). Next, among the other half of the study population, measurement properties for the developed short questionnaire were calculated using goodness of fit indices from confirmatory factor analysis (CFA).</p><p><strong>Results: </strong>The item reduction process (n=1199) resulted in a questionnaire of 22 items (PH22) with a four-factor structure and explained variance of 62.4%. Cronbach's alpha values were 0.84, 0.92, 0.81 and 0.78 for the renamed factors 'Physical fitness' (5 items), 'Contentment with self, others and life' (nine items), 'Daily life management' (5 items) and 'Future perspective' (3 items), respectively. Cross-validation (n=1258) showed adequate goodness-of-fit indices of the PH22, based on both first-order and second-order CFA. The scores of the PH22 were normally distributed. No floor or ceiling effects were present.</p><p><strong>Conclusions: </strong>A short 22-item questionnaire to measure self-reported Positive Health in a general (Dutch) population for evaluative purposes such as scientific or policy research at Positive Health or patient-centred interventions was developed and cross-validated, named PH22. This study supports its structural validity. To use this questionnaire in practice, its test-retest reliability and responsiveness should also be known. Future research has to reveal this.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e091377"},"PeriodicalIF":2.4,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11934353/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143708524","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}