BMJ Open最新文献

{"title":"Social, personal and medical factors influencing treatment delay for patients with primary glaucoma during the COVID-19 pandemic: a qualitative interview study.","authors":"Hua Liu, Lina Sun, Yan Li, Wei Liu, Shaochong Bu, Shaohui Huang, Dan Hu, Jing Yan, Tong Bian, Shuang Li, Qian Li, Jingyi Shi, Ping Zhou, Yan Xing","doi":"10.1136/bmjopen-2024-096469","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-096469","url":null,"abstract":"<p><strong>Background: </strong>Primary glaucoma patients faced many difficulties that affected their treatment during the COVID-19 pandemic. Glaucoma treatment often starts with prescription eye-drops. However, delays in ophthalmic therapy often occur due to poor awareness of the dangers of glaucoma, which subsequently leads to irreversible visual field defects and eventual blindness.</p><p><strong>Objective: </strong>This study aimed to explore the social, personal and medical factors that contributed to barriers in the treatment of primary glaucoma during the COVID-19 pandemic, with the overarching goal of providing insights to develop measures that can identify the barriers of the treatment process and prevent consequent adverse outcomes.</p><p><strong>Methods: </strong>We adopted a phenomenological approach and used purposive sampling to recruit 122 patients into our study. Face-to-face, semistructured, one-on-one interviews were conducted in a private office. The data were analysed using Colaizzi's seven-step method. In cases where classification was difficult, consensus was reached among the three researchers who formed the core assessment team.</p><p><strong>Results: </strong>A total of 122 glaucoma patients experienced delayed pharmaceutical treatment during the outbreak. Delays were longer among females and patients over 75 years old, highlighting that treatment delays were a significant issue for glaucoma patients during the COVID-19 pandemic, particularly for older females. Coding of the transcripts yielded three themes (eight subthemes): (1) the impact of social support on glaucoma pharmaceutical treatment: (a) the inability to seek pharmaceutical treatment alone and (b) online reservation and payment requirements; (2) the impact of personal reasons on glaucoma pharmaceutical treatment: (c) fear of being infected with COVID-19, (d) being infected with COVID-19 or coming into contact with COVID-19 patients, (e) being busy with work or life; (3) the impact of medical resources on glaucoma pharmaceutical treatment: (f) abnormal diagnosis and treatment processes, (g) insufficient medical manpower and (h) insufficient communication from medical staff.</p><p><strong>Conclusions: </strong>To prevent medication delays and potential irreversible damage to the visual field in primary glaucoma patients during health crises, it is essential to further explore personalised strategies for coping with the impact of pandemics. Special attention should be given to glaucoma patients facing significant life burdens, such as the elderly and females, and efforts should be made to increase their awareness of the risks of glaucoma. Future studies could explore the feasibility of providing more support to glaucoma patients, such as online payment and appointment scheduling options, to reduce delays and alleviate patient anxiety.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e096469"},"PeriodicalIF":2.4,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742328","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality indicators for substance use disorder care: a scoping review protocol.","authors":"Ti-Amo DeRuz Richards, Julia Kirkham, Diane Lorenzetti, Jennifer Anderson, Anees Bahji, Youssef Allami, David Crockford, Michele P Dyson, Sumantra Monty Ghosh, David Hodgins, Geoffrey Messier, Shelly Vik, Dallas P Seitz","doi":"10.1136/bmjopen-2024-085216","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-085216","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Substance use disorders (SUDs) are a major public health challenge, affecting millions of individuals globally and contributing to substantial morbidity and mortality. Individuals with SUDs face numerous barriers to accessing high-quality healthcare, leaving vulnerable populations susceptible to the undertreatment of SUDs. Despite the availability of clinical practice guidelines and effective interventions for SUD, there is a notable gap in the implementation and adherence to evidence-based care.Measuring the quality of care (QoC) is a critical initial step toward enhancing the treatment and services provided to individuals with SUDs. While quality indicators (QIs) for SUD care have been established in various regions, including the USA, Canada and the UK, the application of QIs for the routine measurement of QoC for SUDs is not common. Identifying and characterising the areas of low QoC in SUD management can highlight critical targets for quality improvement initiatives. However, QoC measurement in SUD care is complex, with potentially redundant indicators derived from different sources, each with its own definitions, criteria and data requirements. This scoping review aims to explore the range of QIs that are currently available to assess the QoC for individuals with SUDs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The review will follow the Arksey and O'Malley framework and incorporate methods proposed by the Joanna Briggs Institute (JBI) and Levac &lt;i&gt;et al&lt;/i&gt;. Reporting will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping review guidelines (PRISMA). Stage 1: the research question will be identified, clarifying the purpose of the scoping review. Stage 2: six academic databases (Cochrane Library, Embase, CINAHL, Medline, APA PsycINFO and Scopus) and grey literature sources will be searched for studies reporting QIs and published from 1990 until 2023. Stage 3: study screening and selection will be completed by two reviewers independently to review titles, abstracts and full texts based on study inclusion criteria. Stage 4: a pilot data charting form has been developed to capture information from each study, including study design, population details, setting, methodology for QI development and reported QIs. Stage 5: data synthesis and consultation will employ thematic analysis and frequency counts to categorise identified QIs within established domains for quality of healthcare. Any discrepancies in data extraction or thematic synthesis will be identified and resolved using a third reviewer when necessary. A consultation exercise using a modified Delphi process will engage experts to prioritise identified QIs, aligning with JBI recommendations for stakeholder involvement in scoping reviews.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Patients and public involvement: &lt;/strong&gt;Patients and the public will not be directly involved in the design or conduct of this scoping review. However, stakeholder con","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e085216"},"PeriodicalIF":2.4,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of infant and young child feeding practices in low-income areas of Dhaka, Bangladesh: insights from a cross-sectional study using the 2021 WHO/UNICEF guideline.","authors":"Tasmia Tasnim, Md Hafizul Islam, Ali Abbas Mohammad Kurshed, Saiful Islam, Sadia Sultana, Kazi Muhammad Rezaul Karim","doi":"10.1136/bmjopen-2024-093064","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-093064","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to assess the status of infant and young child feeding (IYCF) practices and associated factors among children aged 0-23 months in the low-income regions of Dhaka City, Bangladesh.</p><p><strong>Design: </strong>A community-based cross-sectional study.</p><p><strong>Settings: </strong>Low-income regions of Dhaka City, Bangladesh.</p><p><strong>Participants: </strong>530 children aged 0-23 months and their mothers.</p><p><strong>Primary and secondary outcome measures: </strong>Prevailing IYCF practices were assessed against the 17 indicators of IYCF recommended by the WHO/UNICEF in 2021. Modified Poisson regression models were built to explore the relation between socio-demographic variables and each of the selected IYCF indicators (early initiation of breastfeeding (EIBF), exclusive breastfeeding (EBF), minimum dietary diversity (MDD), minimum meal frequency (MMF) and minimum acceptable diet (MAD)).</p><p><strong>Results: </strong>More than two-thirds of the children were reported to follow appropriate breastfeeding practices (EIBF, 70.4% and EBF, 60.9%). Among the complementary feeding indicators, almost half of the children (48.8%) were reported to meet MMF; however, only about 26% of the children reportedly met the MDD with a consequent low prevalence (22.9%) of the composite indicator MAD. More than half (55%) of the children were reported to consume egg and/or flesh food consumption; still, inappropriate dietary practices were observed among 60% had unhealthy food consumption, and 56% had zero vegetable or fruit consumption). Child age was a significant determinant of IYCF practices. The children of mothers with no pregnancy complications exhibited a greater chance of having EIBF (estimate: 1.21, 95% CI: 1.04, 1.42, p=0.02), MDD (Estimate: 1.67, 95% CI: 1.09, 2.55, p=0.02), and MAD (estimate: 1.70, 95% CI: 1.04, 2.77, p=0.03) compared with the children of mothers with pregnancy complications. The children with a mother having secondary or higher education had a higher chance of having MDD (estimate: 1.93, 95% CI: 1.35, 2.76, p=0.003) and MMF (estimate: 1.27, 95% CI: 1.03, 1.56, p=0.02) than the children of mothers having primary or no education. Similarly, children from higher-income households had a higher chance of getting MDD (estimate: 1.57, 95% CI: 1.07, 2.03, p=0.02), and MAD (estimate: 1.73, 95% CI: 1.14, 2.64, p=0.01) compared with children from lower-income households.</p><p><strong>Conclusion: </strong>IYCF practices among a considerable proportion of children aged 0-23 months in the low-income regions of Dhaka City were found to be suboptimal and predicted by children's age, maternal education and pregnancy complications, and household income.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e093064"},"PeriodicalIF":2.4,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742318","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Connecting patients with clinical trials using patient navigation: a scoping review protocol.","authors":"Olla Hilal, Pratham Gupta, Nasong Anthony Luginaah, Leena Moshref, Nicole Askin, Carla Epp, Renee Nassar, Roaa Hirmiz, Milica Paunic, Mahmoud Hossami, Rhonda Abdel-Nabi, Kayla Touma, Depen Sharma, Rija Fatima, Emmanuel Akingbade, Caroline Hamm, Megan Delisle","doi":"10.1136/bmjopen-2024-088828","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-088828","url":null,"abstract":"<p><strong>Introduction: </strong>Interventions are needed to increase participation in clinical trials through optimised trial design and enrolment workflows. Patient navigation is a promising intervention for increasing participation in clinical trials by optimising enrolment workflows. Patient navigation is defined as a personalised intervention aimed at overcoming barriers and ensuring timely access to healthcare services, diagnosis, treatment and care. This scoping review aims to fill a gap in current literature by summarising what is known about patient navigation, aiming to increase clinical trial participation.</p><p><strong>Methods and analysis: </strong>A search was conducted for peer-reviewed literature published in English from inception through 21 December 2023, and the search was updated on 5 March 2025. Sources of literature included Cochrane CENTRAL (Ovid), MEDLINE (Ovid), EMBASE (Ovid), Cumulative Index of Nursing and Allied Health (CINAHL; on EBSCOhost; EBSCO Industries, Inc), Epistemonikos and PROSPERO databases. Searches were also conducted through the Turning Research into Practice and International Clinical Trials Registry Platform (WHO) databases, Google Scholar and the Agency for Health Research and Quality platform to ensure the retrieval of all relevant articles. Reference lists of eligible studies were also examined. The Google Scholar search was limited to the first 10 pages of results. The search strategy focused on the following key concepts: navigation (eg, navigator, care coordination, case management) and clinical trials. Searches were reviewed using the PRESS Peer Review of Electronic Search Strategies 2015. This review was guided based on the JBI methodology for scoping reviews using a five-step review process: identify the research questions; search and identify relevant studies; select studies based on a priori criterion; chart the data; and collate, summarise and report the results according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews.</p><p><strong>Ethics and dissemination: </strong>This scoping review identifies and analyses existing research; therefore, ethics approval is not required. Findings will be disseminated through conference presentations and a publication in a scientific journal.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e088828"},"PeriodicalIF":2.4,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742300","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mapping the evidence on the assessment of fitness to work at heights: a scoping review.","authors":"Lyndsey Swart, Tania Buys, Nicolaas Claassen","doi":"10.1136/bmjopen-2024-093525","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-093525","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;Falls from heights are a leading cause of workplace injuries and fatalities. Ensuring worker fitness is crucial, yet many countries lack formal guidelines for fitness for work (FFW) assessments, posing safety and legal risks. This scoping review sought to identify and map the existing evidence on the assessment of fitness to work at heights.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design: &lt;/strong&gt;Scoping review following the Joanna Briggs Institute Scoping Review Methodology and Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Data sources: &lt;/strong&gt;Searches were conducted in March 2024 across ProQuest Central, Google Scholar, PubMed, Scopus, ScienceDirect, Web of Science and PsycINFO. Grey literature was sourced from the websites of organisations including the International Labour Organisation, Safe Work Australia, Canadian Centre for Occupational Health and Safety, Health and Safety Executive (UK), Occupational Safety and Health Administration (USA), WHO, Centre for Construction Research and Training (USA), Institution of Occupational Safety and Health (UK), South African Society of Occupational Medicine, South African Society of Occupational Health Nursing and Institute for Work at Height (South Africa), in addition to general Google searches.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Eligibility criteria for selecting studies: &lt;/strong&gt;Our inclusion criteria encompassed both peer-reviewed and grey literature that addressed either 'fitness for work at heights', 'fitness for work in high-risk settings requiring work at heights' or human risk factors associated with working at heights.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Data extraction and synthesis: &lt;/strong&gt;A data extraction framework and guidance sheet were developed, piloted and refined through team discussions. An iterative review process was followed, with one author extracting and coding data while two authors conducted quality checks. Deductive qualitative content analysis was applied to the extracted data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;68 articles met the inclusion criteria, but only 7 directly addressed fitness to work at heights, with the rest focusing on fitness to work in high-risk settings requiring work at heights or human risk factors associated with work at heights. This highlights a lack of peer-reviewed research specific to the topic. Key challenges included FFW assessments failing to reflect job demands, inconsistent application of FFW evaluations, lack of standardisation and inadequate stakeholder collaboration. Legal tensions between employer safety obligations and worker rights were also noted. Critical human risk factors-such as physical and mental limitations, adverse states, human error and rule violations-significantly affected worker safety, though evidence of their specific impact in this context remained limited. Findings on the economic implications of FFW assessments were also inconclusive.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Asses","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e093525"},"PeriodicalIF":2.4,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Changes in peripapillary microvasculature and retinal nerve fibre layer in diabetes and diabetic retinopathy using optical coherence tomographic angiography: a community-based, cross-sectional study.","authors":"Jiahui Liu, Dan Kang, Zhiyi Xu, Qianhong Xian, Shuhui Chen, Shulun Zhao, Jiali Li, Xuewen Huang, Wei Wang, Wenyong Huang, Minyu Chen, Lanhua Wang","doi":"10.1136/bmjopen-2023-079572","DOIUrl":"https://doi.org/10.1136/bmjopen-2023-079572","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate changes in the peripapillary retinal microvasculature and retinal nerve fibre layer (RNFL) in diabetic participants with various stages of diabetic retinopathy (DR) using swept-source optical coherence tomographic angiography (OCTA).</p><p><strong>Design: </strong>Community-based, cross-sectional study.</p><p><strong>Setting: </strong>This study was conducted in a tertiary teaching hospital in Guangzhou, China.</p><p><strong>Participants: </strong>A total of 1325 ocular-treatment-naive participants, of whom 1115 had no DR and 210 had DR, were recruited in a community in Guangzhou, China.</p><p><strong>Primary and secondary outcome measures: </strong>A commercially available OCTA device was used to obtain various peripapillary retinal microvascular metrics centred on the optic disc, including vessel density (VD), vessel length density (VLD) and vessel diameter index (VDI). The peripapillary RNFL thickness was automatically obtained using built-in software. Linear regression analyses were used to evaluate the association of the peripapillary OCTA parameters (VD, VLD and VDI), RNFL thickness with various DR stages and average RNFL thickness with peripapillary OCTA parameters.</p><p><strong>Results: </strong>Moderate and severe DR had progressively decreased VD in the peripapillary ring (β = -0.72, 95% CI = -1.31 to -0.14 and -1.79, 95% CI = -2.81 to -0.77, respectively) and other regions (all p<0.05). Similar changes were observed between peripapillary VLD and moderate and severe DR (all p<0.05). Moderate (β = -4.56, 95% CI = -8.97 to -0.15, p=0.043) and severe DR (β = -10.12, 95% CI = -18.29 to -1.95, p=0.015) had significant thinner peripapillary RNFL in the inferior quadrant. VD and VLD were linearly associated with the average RNFL in the peripapillary ring and average peripapillary area (all p<0.05).</p><p><strong>Conclusions: </strong>The peripapillary retinal microvasculature and RNFL were significantly reduced with the progression of DR, which suggests that monitoring differences in peripapillary microvasculature and the RNFL may be a promising approach to detecting DR progression.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e079572"},"PeriodicalIF":2.4,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742296","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drive-the-doctor paradigm in acute ischaemic stroke for improving regional stroke care networks: a cost-effectiveness analysis.","authors":"Chi Phuong Nguyen, Maarten Uyttenboogaart, Willemijn J Maas, Erik Buskens, Maarten M H Lahr, Durk-Jouke van der Zee","doi":"10.1136/bmjopen-2024-091413","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-091413","url":null,"abstract":"<p><strong>Background and objective: </strong>In a drive-the-doctor (DD) paradigm, an interventionalist travels from a comprehensive stroke centre (CSC) to primary stroke centres (PSCs) to perform endovascular thrombectomy (EVT) for acute ischaemic stroke due to large vessel occlusion (LVO). The DD paradigm may reduce time delays from onset to recanalisation. This study aimed to analyse the cost-effectiveness of the DD paradigm versus a drip-and-ship (DS) paradigm, where LVO patients are transferred from PSCs to a CSC for EVT in the northern Netherlands.</p><p><strong>Design: </strong>Economic evaluation was performed using a simulation model combined with a decision tree and a Markov model.</p><p><strong>Setting: </strong>Stroke centres in the northern Netherlands.</p><p><strong>Participants: </strong>A hypothetical cohort of 100 000 LVO patients with an average age of 70 years.</p><p><strong>Interventions: </strong>Two strategies were tested, including the DD paradigm with one upgraded PSC and the DD paradigm with two upgraded PSCs.</p><p><strong>Main outcome measures: </strong>Total costs and quality-adjusted life years (QALYs) were measured over a 15-year time horizon from a Dutch healthcare provider perspective. An incremental cost-effectiveness ratio (ICER) of €50 000 was used as a willingness-to-pay threshold. One-way sensitivity, probabilistic sensitivity and scenario analyses (interventionalist transportation by car, ambulance and helicopter) were conducted to examine parameter uncertainty.</p><p><strong>Results: </strong>The DD paradigm using car as a transport modality and two PSCs was the optimal strategy, resulting in the lowest ICER. This strategy provided an additional 0.13 QALYs at incremental costs of €2367, yielding an ICER of €18 306 compared with current practice. The DD paradigm with two PSCs reduced ICERs compared with the scenario with one PSC when varying transportation modalities (car, ambulance and helicopter). Probabilistic sensitivity analyses showed that the DD paradigm with two PSCs using car was preferred in 72% of 10 000 Monte Carlo simulations.</p><p><strong>Conclusions: </strong>The DD paradigm appeared cost-effective for LVO patients and may be considered a promising evolution for a regional stroke network.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e091413"},"PeriodicalIF":2.4,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742316","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol for a single-centre randomised pilot study to assess the safety and feasibility of adding a CytoSorb filter during kidney normothermic machine perfusion to remove inflammatory and immune mediators prior to kidney transplantation.","authors":"Maithili Mehta, Sarah Hosgood, Michael L Nicholson","doi":"10.1136/bmjopen-2024-093001","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-093001","url":null,"abstract":"<p><strong>Introduction: </strong>The introduction of perfusion technologies in kidney transplantation has the potential to improve graft function and survival and increase utilisation. Our previous work demonstrated that kidneys with an enhanced inflammatory and immune response during normothermic machine perfusion (NMP) had significant graft dysfunction after transplantation. The addition of a cytokine filter (CytoSorb) to the NMP circuit dramatically reduces both circulating inflammatory mediators and inflammatory gene expression, but this has not been trialled in clinical practice.</p><p><strong>Methods and analysis: </strong>This is a randomised phase 1 pilot study to evaluate the safety and feasibility of using a CytoSorb filter in clinical NMP to remove inflammatory and immune mediators. Eligible kidney transplant recipients on the waiting list in the East of England will be approached for consent. A total of 20 patients will be recruited and randomised in a 1:1 ratio for the donor kidney to receive either NMP or NMP with a CytoSorb filter pre-transplantation. The kidney will be transplanted according to standard practice after NMP. The primary endpoint is inflammatory and immune gene expression measured in a cortical biopsy from the kidney 60 min post-transplant. Secondary endpoints include rates and duration of delayed graft function and graft function as assessed by change in creatinine clearance and estimated glomerular filtration rate 2 days, 5 days, 1 month and 3 months post-transplant. Additionally, inflammatory mediators and injury markers will be measured in peripheral blood and urine samples taken pre-operatively and on days 2 and 5 after transplant.</p><p><strong>Ethics and dissemination: </strong>This study has been approved by the Health Research Authority Health and Care Research Wales Committee (REC 23/WM/0141) and by National Health Service (NHS) Blood and Transplant (Ref: Study 148). Findings will be published in a peer-reviewed journal and disseminated at scientific conferences. The dataset will be made available on request.</p><p><strong>Trial registration: </strong>The study is prospectively registered on the ISCRTN registry (ID: 13698207).</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e093001"},"PeriodicalIF":2.4,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of the psychometric properties of patient-reported outcome measures of health-related quality of life across the European cancer continuum: a systematic review protocol using COSMIN methodology.","authors":"Laurence Leysen, Karla Marticic Giljevic, Claire Piccinin, Morena Shkodra, Madeline Pe, Morten Petersen, Giovanni Apolone, Cinzia Brunelli, Claudio Lombardo, Galina Velikova, Alexandra Gilbert, Gabriella Pravettoni, Gennaro Ciliberto, Mogens Groenvold, Montserrat Ferrer, Nanne Bos, Ricardo Pietrobon, Norbert Couespel, Augusto Caraceni, Marianne Guren, Aude Sirven, Hugo Vachon","doi":"10.1136/bmjopen-2024-088716","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-088716","url":null,"abstract":"<p><strong>Introduction: </strong>Over the past decades, there has been increasing recognition that assessing patients with cancer's health-related quality of life (HRQoL) is pivotal to delivering optimal patient-centred healthcare. However, with the increasing number of patient-reported outcome measures (PROMs) available, it becomes more and more challenging to identify the most appropriate PROM to capture HRQoL. Therefore, the aim of this systematic review is to (1) identify all available PROMs assessing HRQoL across the European cancer continuum and (2) critically appraise, compare and summarise the psychometric properties of the identified PROMs.</p><p><strong>Methods and analysis: </strong>Bibliographic databases MEDLINE and PubMed Central (through PubMed) and EMBASE (through Scopus) will be comprehensively searched from database inception until March 2024. Studies reporting on the measurement properties of PROMs assessing HRQoL throughout the European cancer continuum will be included. The evaluation of the psychometric properties, data extraction and data synthesis will be conducted according to the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology. Two reviewers will independently assess the methodological quality using the COSMIN risk of bias checklist and the COSMIN criteria for good measurement properties. Subsequently, findings will be qualitatively summarised. The Grading of Recommendations Assessment, Development and Evaluations (GRADE) guidelines will be used to grade and summarise the quality of the evidence.</p><p><strong>Ethics and dissemination: </strong>Ethical clearance for this research is not required, as the systematic review will only use information from previously published research. The results of this review will be submitted for publication in a peer-reviewed journal and will be used to provide a set of evidence-based recommendations for a European project (EUonQOL), which aims at developing a new PROM (EUonQOL toolkit) to assess HRQoL across the European cancer continuum. Moreover, findings will be disseminated to a clinical audience and policymakers through conferences, supporting researchers and clinicians in choosing the best measure to evaluate HRQoL in patients with cancer and survivors in Europe.</p><p><strong>Prospero registration number: </strong>CRD42023418616.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e088716"},"PeriodicalIF":2.4,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742320","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction for 'Protocol for a randomised 'screen-andtreat' Helicobacter pylori eradication trial in 14-18-years-old adolescents residing in three regions of Chile: effectiveness and microbiological host implications'.","authors":"","doi":"10.1136/bmjopen-2024-084984corr1","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-084984corr1","url":null,"abstract":"","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 3","pages":"e084984corr1"},"PeriodicalIF":2.4,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742303","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}