{"title":"A sham-controlled randomised trial of Tecar therapy for painful caesarean scars: the NOCEPAIN study protocol.","authors":"Manon Grampayre, Candy Guiguet-Auclair, Chloé Barasinski, Françoise Vendittelli","doi":"10.1136/bmjopen-2025-105743","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-105743","url":null,"abstract":"<p><strong>Introduction: </strong>Caesarean section is a frequent procedure in obstetrics, accounting for 21.4% of deliveries in France in 2021. Three months after delivery, 15.4% of these women report they still have pain, which can be associated with psychological disorders (including anxiety and depression). Although the only treatment currently recommended is self-massage of the scar, capacitive and resistive electric transfer (Tecar) therapy could improve healing and reduce pain associated with caesarean scars and, therefore, improve women's health-related quality of life (QoL). We aim to evaluate the analgesic efficacy of Tecar therapy for postoperative scar pain and/or discomfort at 3 months postpartum by comparing it with sham Tecar therapy.</p><p><strong>Methods and analysis: </strong>The NOCEPAIN study is a two-centre, single-blind, two-arm, parallel-group, sham-controlled randomised trial currently underway. A total of 120 women with a caesarean scar still painful at 6-8 weeks postpartum, aged 18-50 years, are being randomly allocated in a ratio of 1:1 to either the active Tecar therapy group (active device group) or the sham Tecar therapy group (placebo device group). The women undergo one Tecar or sham session of 20 min per week for 3 weeks. Women in both groups also receive the recommended standard treatment: manual self-massage of the scar.The primary outcome is the caesarean scar pain and/or discomfort at 3 months postpartum, assessed with a Visual Analogue Scale from 0 (no pain and/or discomfort) to 10 (the worst imaginable). Secondary outcomes include validated self-report questionnaires about pain (French adaptations of the McGill Pain Questionnaire and the Brief Pain Inventory, as well as the 'Douleur Neuropathique en 4 Questions' instrument for neuropathic pain), the interference of pain with activities of daily living (Multidimensional Pain Inventory), anxiety and depression (Hospital Anxiety and Depression Scale), health-related QoL (WHO QoL Brief) and sexual functioning (Female Sexual Function Index). The final secondary outcomes are the quality of skin healing (Vancouver Scar Scale), as well as analgesic use and concomitant treatments for analgesia.</p><p><strong>Ethics and dissemination: </strong>The West III Committee for the Protection of Persons (French Institutional Review Board) approved this study and its compliance with French individual data protection laws (number: 2022-A01492-41, 20 March 2023). All participants provide written informed consent before randomisation. The results will be reported in peer-reviewed journals and at scientific meetings.</p><p><strong>Trial registration number: </strong>NCT05696301.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e105743"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243782","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}
BMJ OpenPub Date : 2025-10-06DOI: 10.1136/bmjopen-2025-099668
Shujing Wu, Ning Chen, Mengzhang Wu, Yongquan Wang, Zhaoming Huang, Jie Zhang, Jianan Li, Demin Xu, Lihua Guan, Junbo Ge
{"title":"Association between blood pressure and metabolic dysfunction-associated fatty liver disease among adults without hypertension: a cross-sectional analysis of the National Health and Nutrition Examination Survey 2017-2018.","authors":"Shujing Wu, Ning Chen, Mengzhang Wu, Yongquan Wang, Zhaoming Huang, Jie Zhang, Jianan Li, Demin Xu, Lihua Guan, Junbo Ge","doi":"10.1136/bmjopen-2025-099668","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-099668","url":null,"abstract":"<p><strong>Objective: </strong>High blood pressure (BP) is one of the optional components of metabolic dysfunction-associated fatty liver disease (MAFLD). However, whether subclinical elevations in BP are related to MAFLD even in the absence of hypertension remains unclear. We investigated the association between BP and MAFLD among adults without hypertension.</p><p><strong>Design and setting: </strong>A nationwide, multicentre and cross-sectional study of the National Health and Nutrition Examination Survey (NHANES).</p><p><strong>Participants: </strong>2022 US adults without hypertension were recruited in the 2017-2018 cycle of the NHANES.</p><p><strong>Exposure: </strong>Systolic BP (SBP) and diastolic BP (DBP).</p><p><strong>Outcome measures: </strong>MAFLD was defined by the novel consensus of diagnostic criteria in 2020.</p><p><strong>Results: </strong>MAFLD is common among US adults even at the 'normal' BP ranges, with a prevalence of 38.8%. We observed a positive, linear relationship between SBP and MAFLD down to 90 mm Hg, and between DBP and MAFLD down to 50 mm Hg. The MAFLD risk was elevated significantly with increasing SBP level (per 10 mm Hg increase: adjusted OR, 1.59 (95% CI, 1.21 to 2.09)) in the range of 90-129 mm Hg. The relationship between DBP and MAFLD was not evident (per 10 mm Hg increase: adjusted OR, 1.42 (95% CI, 0.96 to 2.21)) in the range of 50-79 mm Hg. Similar findings were identified in the sensitivity analyses.</p><p><strong>Conclusions: </strong>In a population without hypertension, SBP is significantly associated with MAFLD, indicating potential early intervention to prevent MAFLD.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e099668"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243629","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}
BMJ OpenPub Date : 2025-10-06DOI: 10.1136/bmjopen-2025-099937
Charlotte Gustorff, Laura Turtschan, Jakob Mühlbacher, Carl-Stephan Leonhardt, Klaus Sahora, Martin Schindl, Oliver Strobel, Ulla Klaiber
{"title":"Impact of video-assisted preoperative patient information on patient-reported outcomes after pancreatic resection (INFORM trial): a study protocol for a randomised controlled pilot trial.","authors":"Charlotte Gustorff, Laura Turtschan, Jakob Mühlbacher, Carl-Stephan Leonhardt, Klaus Sahora, Martin Schindl, Oliver Strobel, Ulla Klaiber","doi":"10.1136/bmjopen-2025-099937","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-099937","url":null,"abstract":"<p><strong>Introduction: </strong>Undergoing pancreatic surgery represents an exceptional situation for the individual patient who therefore requires appropriate preoperative information. In daily clinical practice, however, there is often a lack of time for adequate patient information and education, which may be associated with stress, fears and worries with potentially negative impact on patient-reported and postoperative outcomes. The aim of the INFORM trial is to evaluate the impact of video-assisted preoperative patient information on patient-reported and surgical outcomes in patients scheduled for elective pancreatic resection.</p><p><strong>Methods and analysis: </strong>The INFORM trial is an open-label, randomised controlled pilot trial with two parallel study groups and a planned sample size of 80 patients with any indication for pancreatic resection. The intervention group will receive access to videos providing detailed information on the planned surgery and the perioperative procedures within 2 weeks before surgery in addition to the standard preoperative preparations. The control group will only receive the standard preoperative preparations without video. Quality of life (QLQ), satisfaction with information on disease and treatment as well as disease symptoms will be assessed using the European Organisation For Research and Treatment of Cancer QLQ INFO25, C30 and PAN26 questionnaires. Surgical complications will be assessed according to appropriate classifications by Clavien and Dindo and the International Study Group of Pancreatic Surgery (ISGPS). To account for the potential impact of cancer treatment on the outcome parameters, a subgroup analysis including only patients without malignancy will be performed. In addition, potential influencing factors on QLQ scores will be investigated by comparing QLQ scores among appropriate subsets of patients.</p><p><strong>Ethics and dissemination: </strong>This trial was approved by the institution's Ethics Committee (reference number 1479/2024). All trial procedures are performed in accordance with the ICH E6 harmonised tripartite guideline on Good Clinical Practice and the ethical principles of the Declaration of Helsinki. Once the study has been completed, the results will be published in due course.</p><p><strong>Trial registration details: </strong>German Clinical Trial Register number: DRKS00035173. Registered 14 October 2024 (https://drks.de/search/de/trial/DRKS00035173/details).</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e099937"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243692","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":"Shared decision-making using a decision aid for patients with breast cancer considering breast reconstruction: study protocol for a cluster-randomised controlled trial in Japan.","authors":"Yoshihiro Sowa, Wakako Osaka, Itaru Tsuge, Takako Komiya, Miho Saiga, Mifue Taminato, Naomi Nagura, Tomohiro Shiraishi, Hirohito Seki, Yuki Otsuki, Yuki Matsuoka, Shoichi Tomita, Shinsuke Akita, Hiroshi Fujimoto, Kazuhiro Otani, Kotaro Yoshimura","doi":"10.1136/bmjopen-2024-094553","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-094553","url":null,"abstract":"<p><strong>Introduction: </strong>Shared decision-making (SDM) requires that individuals are correctly and smoothly supported to make decisions. However, in Japan, development of decision aids (DAs) to support implementation of SDM is lagging behind Western countries, and there are few reports focused on breast reconstruction. Thus, it is unclear if SDM using a DA in the context of the unique national character and medical culture in Japan is useful in decision-making for breast reconstruction, including whether or not to undergo reconstruction. The aim of this multicentre collaborative study is to investigate the clinical effectiveness of SDM using a DA for patients with breast cancer considering reconstruction, from the perspectives of decisional conflict and postoperative quality of life.</p><p><strong>Methods and analysis: </strong>A multisite trial will be conducted at 12 facilities certified by the Japanese Society of Breast Oncoplastic Surgery. A cluster-randomised controlled trial is planned at centres that have implemented SDM with DAs and those that have not implemented SDM, but use a conventional surgical explanation and informed consent to make decisions about reconstruction methods. The study participants will be female patients aged ≥20 years with newly diagnosed stage 0-III breast cancer who are interested in breast reconstruction. Data collection includes baseline and follow-up patient surveys and medical record review. The effectiveness of the DA at reducing conflict and regret in decision-making (primary outcome) will be evaluated using the decision conflict scale.</p><p><strong>Ethics and dissemination: </strong>This protocol has been approved by the Kyoto University Central Institutional Review Board, and permission for performance of the study has been obtained from the Ethics Review Board at each participating centre. We plan to disseminate the findings through journal publications and national meetings, including a presentation of the research results at the Japanese Society of Breast Oncoplastic Surgery. Our findings will advance the science of medical decision-making and have the potential to reduce socioeconomic health disparities.</p><p><strong>Trial registration number: </strong>UMIN000052161.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e094553"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243704","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}
BMJ OpenPub Date : 2025-10-06DOI: 10.1136/bmjopen-2025-102773corr1
{"title":"<i>Correction</i>: 'ARBOR-Telehealth study: an examination of telerehabilitation to improve function and reduce opioid use in persons with chronic low back pain in rural communities - protocol of a pragmatic, individually randomised group treatment trial'.","authors":"","doi":"10.1136/bmjopen-2025-102773corr1","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-102773corr1","url":null,"abstract":"","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e102773corr1"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243803","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}
BMJ OpenPub Date : 2025-10-06DOI: 10.1136/bmjopen-2025-101969
Shoba Ramanadhan, Sitara L Mahtani, Marina D'Costa, Gauri Mandal, Dinesh Jagiasi, Ratandeep Chawla, Sara Minsky, Ziming Xuan, Morgan Mulhern Lopez, Himanshu Gupte
{"title":"Adaptation drivers of evidence-based brief advice/counselling for tobacco use in high-reach, low-resource settings in Mumbai: a qualitative exploration with patients, practitioners and policymakers.","authors":"Shoba Ramanadhan, Sitara L Mahtani, Marina D'Costa, Gauri Mandal, Dinesh Jagiasi, Ratandeep Chawla, Sara Minsky, Ziming Xuan, Morgan Mulhern Lopez, Himanshu Gupte","doi":"10.1136/bmjopen-2025-101969","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-101969","url":null,"abstract":"<p><strong>Introduction: </strong>Tobacco use accounts for approximately 1.35 million deaths annually in India, disproportionately affecting low-income individuals, men, rural residents, those without formal education and groups of low socioeconomic status (SES). Despite progress in tobacco control, scalable, low-cost solutions, such as brief advice interventions, are needed. This study explored priority implementation determinants for adapting an evidence-based brief advice/counselling intervention for high-reach, low-resource settings in Mumbai, India. The focal settings (health-focused and tuberculosis-focused non-governmental organisations (Health NGOs and TB NGOs) and dental clinics) served low-SES populations.</p><p><strong>Methods: </strong>Mumbai-based and US-based team members conducted a qualitative study employing semistructured interviews to gather data from four groups connected to Health and TB NGOs and dental clinics: (1) 15 patients, (2) 33 practitioners, (3) nine practice leaders and (4) three policymakers. We used a team-based, critical, reflexive thematic analysis approach to analysis, grounded in the Exploration, Preparation, Implementation and Sustainment framework. We managed data with Nvivo software.</p><p><strong>Results: </strong>Participants were supportive but highlighted diverse challenges and supports required for implementing the intervention in these diverse settings. First, many noted that societal constraints such as economic insecurity and cultural factors were expected to limit tobacco control efforts for low-SES populations. Second, setting-specific intervention adaptations were identified as necessary to support integration and ensure access to support for all patients. Various participant groups highlighted different adaptation areas. For example, patients noted that tobacco was part of their routines and social lives, practitioners emphasised the need to design implementation plans that support integration alongside existing needs, and policymakers highlighted the need for uniform implementation strategies.</p><p><strong>Conclusion: </strong>Adapting brief advice/counselling interventions for Health NGOs, TB NGOs and dental clinics in Mumbai will require strategic communication to support buy-in, thoughtful workflow integration and changes to funding and support mechanisms for organisations so meaningful reductions in tobacco use can be achieved among low-SES groups. In other words, there is a need to adapt both the intervention and the implementing system to allow for brief advice/counselling to contribute to broader tobacco control efforts.</p><p><strong>Trial registration: </strong>R01 CA230355.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e101969"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243522","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":"'My body isn't perfect, and I get quite anxious': a qualitative exploration of body image dissatisfaction among Chinese female undergraduates.","authors":"Danli He, Ching Sin Siau, Hui Chin Koo, Yimei Zheng, Ping He, Harvinder Kaur Gilcharan Singh","doi":"10.1136/bmjopen-2025-099390","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-099390","url":null,"abstract":"<p><strong>Objectives: </strong>Body image dissatisfaction (BID) is relatively common in Chinese female undergraduates. This study aims to explore the reasons for BID among female undergraduates to develop effective early intervention strategies.</p><p><strong>Design: </strong>A qualitative research approach was used through semi-structured interviews, allowing for an in-depth understanding of the experiences of participants.</p><p><strong>Setting: </strong>The study was conducted from April 2024 to November 2024 at Yibin University in Sichuan province, China.</p><p><strong>Participants: </strong>The study involved 25 female undergraduates with an average age of 19.8±1.3 years. These participants were selected to provide rich qualitative data about their experiences and views regarding BID.</p><p><strong>Results: </strong>The participants showed a high level of BID, and the thematic analysis revealed five overarching themes regarding the causes of BID among female undergraduates: (1) individual factors; (2) media factors; (3) family factors; (4) peer factors; and (5) overall societal impact.</p><p><strong>Conclusion: </strong>The thematic analysis revealed that dissatisfaction with body image among female undergraduates is a multidimensional issue influenced by various factors, including individual and sociocultural elements. The conclusion emphasises the necessity of strengthening comprehensive intervention measures to address these influencing factors.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e099390"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243661","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":"<i>Support-t</i>, an online training and peer support platform to accompany youth living with type 1 diabetes transitioning to adult healthcare: protocol of an effectiveness-implementation trial.","authors":"Amélie Roy-Fleming, Meranda Nakhla, Elise Mok, Andréanne Vanasse, Liana Cianci, Jessica Kichler, Judith Simoneau-Roy, Yohann Couture, Julie Gagné, Mariève Dupont, Anne-Sophie Brazeau","doi":"10.1136/bmjopen-2025-105514","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-105514","url":null,"abstract":"<p><strong>Introduction: </strong>Type 1 diabetes (T1D) demands self-management skills, knowledge and confidence to prevent medical complications. Adolescents living with T1D have distinct developmental challenges resulting in a worsening in glycaemic stability, irregular care and an increased risk for complications all while transitioning to adult healthcare. Age-specific online platforms could facilitate transition by fostering self-management education and support. The <i>Support</i> online self-guided training platform has been shown to increase the confidence of adults with T1D in managing their glycaemia. We aim to test the effectiveness of <i>Support-t</i> (ie, adapted for youth), compared with usual care, in improving haemoglobin A1c (HbA1c) and to understand the context of its implementation.</p><p><strong>Methods: </strong>We will conduct a multisite, assessor-blinded, randomised controlled, parallel group, two-arm, superiority trial, evaluating effectiveness and implementation of <i>Support-t</i> versus usual care in 200 adolescents (14-16 years old) living with T1D. The active arm will have an 18-month access to <i>Support-t</i>, and their healthcare team will be trained on the platform's content. The control arm will receive usual care. The primary outcome is HbA1c at 18 months. Secondary outcomes include self-efficacy for diabetes self-management, transition readiness, diabetes-specific quality of life, diabetes distress, continuous glucose monitoring metrics, number of severe hypoglycaemic events, diabetic ketoacidosis, T1D-related emergency department visits and hospitalisations as well as engagement and satisfaction. A subgroup of participants in the active arm and of healthcare providers will be interviewed assessing barriers, facilitators, engagement and fidelity of the intervention. Primary analysis will be by intention-to-treat. The difference in mean HbA1c at 18 months (with a 95% CI) will be calculated between both arms. A cost-effectiveness analysis is also planned.</p><p><strong>Ethics and dissemination: </strong>December 8, 2024 version of the protocol was approved by the McGill University Health Centre Research Ethics Board (MP-37-2024-9734). Results will be disseminated through peer-reviewed publications and patient-partners' network.</p><p><strong>Trial registration number: </strong>ClinicalTrials.gov (NCT05910840).</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e105514"},"PeriodicalIF":2.3,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243765","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":"Surgical patients' experiences with the Patients' Safety Checklist (PASC): a qualitative interview study.","authors":"Kristin Harris, Hilde Valen Wæhle, Anette Storesund, Stig Harthug, Randi Julie Tangvik, Denisa Monsen Lukcova, Wenche Håvik, Åse Humberset, Evelyn Stavang, Kjetil Hagerup, Åshild Teigland Tepstad, Ann Kristin Sandsbakk Austarheim, Andy Healey, Nick Sevdalis, Arvid Steinar Haugen","doi":"10.1136/bmjopen-2025-105554","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-105554","url":null,"abstract":"<p><strong>Background: </strong>Engaging patients in surgical safety is challenging and has not been thoroughly investigated. Although surgical checklists and other safety protocols have been introduced across various surgical fields, preventable adverse events still occur, highlighting the need for additional research. A Patient's Safety Checklist (PASC) has been developed and validated for use by surgical patients. Its effect on patient safety and patient outcomes is currently being investigated in a Stepped Wedge Cluster Randomised Controlled Trial (NCT03105713). In connection with this trial, we have examined elective patients' experiences with using the PASC.</p><p><strong>Methods: </strong>An exploratory qualitative study was conducted based on individual in-depth telephone interviews with 31 elective surgical patients. The interviews were carried out across three Norwegian hospitals including seven surgical specialties. The patients interviewed were part of the trial's intervention arm and had used PASC. The interviews were transcribed verbatim, and reflective thematic analysis was applied.</p><p><strong>Result: </strong>Three themes were identified in the data: patient awareness, patient actions and utility value. Patients perceived PASC to increase awareness around surgical information, preparations, what to speak up about and which information to seek and repeat. This awareness led to a series of actions, such as ensuring medication control, optimising their own health, contacting healthcare professionals, asking questions, and for some no actions were needed. Patients perceived PASC to have high utility value for their surgical preparation.</p><p><strong>Conclusions: </strong>The PASC enhanced patients' involvement in surgical care and safety by ensuring they received systematic, accurate, clear, and understandable information and instructions throughout the surgical pathway. It is one of the few existing interventions that specifically focuses on assisting patients in preparing for surgery and managing their recovery. Further research is needed on the implementation of PASC and its adaptation to other clinical settings.</p><p><strong>Trial registration number: </strong>NCT03105713.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e105554"},"PeriodicalIF":2.3,"publicationDate":"2025-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145231460","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}
BMJ OpenPub Date : 2025-10-05DOI: 10.1136/bmjopen-2025-098878
Tao Shen, Guomin Hu, Wei Zhao, Chuan Ren
{"title":"Deep learning prediction of peak oxygen uptake in patients with coronary heart disease: a retrospective study.","authors":"Tao Shen, Guomin Hu, Wei Zhao, Chuan Ren","doi":"10.1136/bmjopen-2025-098878","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-098878","url":null,"abstract":"<p><strong>Objective: </strong>To develop and validate prediction models for peak oxygen uptake (VO₂peak) in patients with coronary heart disease (CHD) using submaximal cardiopulmonary exercise testing (CPET) indicators and deep learning methods.</p><p><strong>Design: </strong>Retrospective model development and validation study.</p><p><strong>Setting: </strong>Cardiac Rehabilitation Centre, Peking University Third Hospital, China.</p><p><strong>Participants: </strong>A total of 10 538 patients with CHD who underwent CPET between January 2014 and December 2019.</p><p><strong>Methods: </strong>Clinical data and CPET indicators were collected. Multiple machine learning and deep learning models were developed and compared. Model performance was assessed using R², mean absolute error (MAE), bias, Bland-Altman analysis and SHapley Additive exPlanations (SHAP) feature importance ranking.</p><p><strong>Results: </strong>The neural network model achieved the best performance (R² = 0.82, MAE=1.55 mL/kg/min, bias=0.08). XGBoost was the best-performing traditional machine learning model (R² = 0.74). SHAP analysis identified eight top-ranked features, including VO₂@AT, OUES, weight, VE/VCO₂ slope, VE/VCO₂@AT, age, gender and HR@AT.</p><p><strong>Conclusion: </strong>The CPET deep learning model shows potential for predicting VO₂peak in CHD patients, but further external validation and prospective studies are required before clinical application.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e098878"},"PeriodicalIF":2.3,"publicationDate":"2025-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145231538","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}