BMJ Open最新文献

{"title":"Recurrence of hypoglycaemia and associated factors among neonates admitted with perinatal asphyxia in Northwest Ethiopia: multicentre, retrospective follow-up study with negative binomial regression.","authors":"Gezahagn Demsu Gedefaw, Temesgen Brilie Asmare, Asnake Tadesse Abate, Wubet Tazeb Wondie, Mulugeta Endalamaw Ayenew, Astewil Moges Bazezew, Tsehayu Melak Siyoum, Degalem Tilahun Worku, Yaregal Semanew Endeshaw","doi":"10.1136/bmjopen-2024-096158","DOIUrl":"10.1136/bmjopen-2024-096158","url":null,"abstract":"<p><strong>Objective: </strong>To estimate the recurrence of hypoglycaemia and the associated factors in neonates with birth asphyxia admitted to the neonatal intensive care unit in Northwest Amhara region's comprehensive specialised hospitals, Northwest Ethiopia, in 2024.</p><p><strong>Design: </strong>A multicentre, institution-based, retrospective follow-up study.</p><p><strong>Setting: </strong>Tertiary hospitals in Northwest Amhara Regional State, Northwest Ethiopia, from 1 July 2020 to 30 July 2024.</p><p><strong>Participants: </strong>A total of 761 neonates with perinatal asphyxia were admitted to the neonatal intensive care unit of selected public hospitals in Northwest Amhara from July 2020 to July 2024.</p><p><strong>Outcome measure: </strong>The primary outcome measure of this study was recurrence of hypoglycaemia. Furthermore, the factors associated with recurrence of hypoglycaemia in newborns with perinatal asphyxia were noted.</p><p><strong>Results: </strong>The average number of hypoglycaemia cases among neonates with birth asphyxia was 2.05 (95% CI 1.939, 2.163) over the 28-day follow-up period. Meningitis (adjusted incidence rate ratio (AIRR)=1.16; 95% CI 1.04, 1.30), feeding in less than 72 hours (AIRR=1.17; 95% CI 1.05, 1.31), stage 3 hypoxic-ischaemic injury (AIRR=1.20; 95% CI 1.04, 1.39), length of hospital stay (AIRR=1.01; 95% CI 1.01, 1.03) and macrosomia (AIRR=1.39; 95% CI 1.19, 1.63) were significant factors associated with recurrence of hypoglycaemia.</p><p><strong>Conclusions and recommendations: </strong>The current study indicated that the mean recurrence of hypoglycaemia in newborns experiencing perinatal asphyxia was considerably higher. Presence of neonatal meningitis, delayed initiation of feeding 72 hours after birth, stage 3 hypoxic-ischaemic injury, length of hospital stay and macrosomia were the key factors associated with recurrence of hypoglycaemia.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e096158"},"PeriodicalIF":2.4,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11973778/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787843","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":"Self-management versus usual care for greater trochanteric pain syndrome (the HIPS trial): study protocol for a randomised controlled trial.","authors":"Thea Morin Melås, John Bjørneboe, Niels Gunnar Juel, Maren Lunder Wefring, Sigrid Skatteboe, Rikke Munk Killingmo, Kaia B Engebretsen, Michael Skovdal Rathleff, Britt Elin Øiestad, Helene Lundgaard Søberg, Are Hugo Pripp, Jens Ivar Brox, Marianne Bakke Johnsen","doi":"10.1136/bmjopen-2024-090688","DOIUrl":"10.1136/bmjopen-2024-090688","url":null,"abstract":"<p><strong>Introduction: </strong>Greater trochanteric pain syndrome (GTPS) is a common and disabling condition characterised by lateral hip pain. The condition often persists for several months, and there is low evidence for any superior treatment. The aim of this study protocol is to describe a randomised controlled trial (RCT) investigating the effectiveness of a self-management programme versus usual care for patients with GTPS.</p><p><strong>Methods and analysis: </strong>The study is designed as an observer-blinded, parallel group, superiority RCTcomparing a self-management programme (n=55) with usual care (n=55). Eligible patients with GTPS will be included based on reproduction of pain on palpation in the greater trochanteric region and at least one positive clinical provocation test. The self-management programme includes 3-5 individual sessions with a physiotherapist over 12 weeks, addressing physical, emotional and behavioural factors deemed relevant by the patient. Usual care will receive general information about GTPS, activity management and are free to seek further treatment in primary care as wanted. The primary outcome measure is the Norwegian version of the Victorian Institute of Sports Assessment for gluteal tendinopathy questionnaire (VISA-G-Norwegian). Outcomes will be assessed at baseline, 3, 6 and 12 months. A longitudinal mixed effects model will be used to assess the effectiveness of treatment on pain and disability across all time points, with the primary endpoint at 6 months. Cost-effectiveness will be expressed by mean incremental cost-effectiveness ratios (ICERs) from a societal and healthcare perspective. Bootstrapping will be used to estimate ICER uncertainty.</p><p><strong>Ethics and dissemination: </strong>The Norwegian Regional Committees for Medical and Health Research Ethics have approved the project (2023/590816), and it will be in accordance with recommendations from the Data Inspectorate at Oslo University Hospital (22/26396). The results from the study will be disseminated through publications in peer-reviewed journals, in conference presentations and through the user representative.</p><p><strong>Trial registration number: </strong>NCT06297148.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e090688"},"PeriodicalIF":2.4,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11973791/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787855","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":"Comparing Analgesic Regimen Effectiveness and Safety after Surgery (CARES): protocol for a pragmatic, international multicentre randomised trial.","authors":"Mark C Bicket, Karim Shiraz Ladha, Simon Haroutounian, Kellie McFarlin, Mary Neff, Rachel L McDuffie, Jennifer F Waljee, Duminda Nalaka Wijeysundera, Chad Brummet, Yi Li","doi":"10.1136/bmjopen-2025-099925","DOIUrl":"10.1136/bmjopen-2025-099925","url":null,"abstract":"<p><strong>Introduction: </strong>Acute pain is commonly experienced by millions of patients who undergo outpatient surgical procedures. Moreover, an increasing number of procedures are performed on an outpatient basis, requiring greater postoperative planning to ensure effective pain management. Analgesic approaches commonly involve prescription opioids and non-steroidal anti-inflammatory drugs (NSAIDs), but an optimal regimen that balances pain and adverse effects has not been identified. In addition, critical gaps in evidence exist regarding how opioids and NSAIDs compare as analgesic regimens after surgery.</p><p><strong>Methods and analysis: </strong>The Comparing Analgesic Regimen Effectiveness and Safety after Surgery (CARES) trial is a pragmatic, international, multicentre randomised trial that enrols adults undergoing three elective surgical procedures (laparoscopic cholecystectomy, breast lumpectomy, hernia repair). Participants are randomised to receive discharge analgesic prescriptions that consist of either NSAIDs or low-dose opioids (ie, 10 pills of oxycodone 5 mg or equivalent), with both groups prescribed acetaminophen around-the-clock. The primary effectiveness outcome is patient-reported worst daily pain intensity over the first 7 days after surgery. The primary safety outcome is the occurrence of opioid and/or NSAID side effects over the first 7 days after surgery. Secondary outcomes are assessed by patient report and medical record review at 1 week, 1 month, 3 months and 6 months after surgery and include sleep disturbance, patient perception of improvement/change after treatment, pain interference, anxiety, depression, health-related quality of life, clinically important adverse events, substance use, opioid misuse, chronic pain, healthcare utilisation related to pain and quality of recovery.</p><p><strong>Ethics and dissemination: </strong>Investigational review boards at the University of Michigan and other sites have approved the CARES trial. The first patient enrolled in CARES in February 2023, with recruitment anticipated through 2026. Dissemination builds on the input of patient partners and other members of an engaged Stakeholder Advisory Board, with activities spanning co-production of summaries to share results with study participants, publications in biomedical journals and lay press, presentations to scientific and community organisations, and other multimedia communication materials.</p><p><strong>Trial registration number: </strong>NCT05722002.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e099925"},"PeriodicalIF":2.4,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11973795/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787741","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":"Framework to guide the use of mathematical modelling in evidence-based policy decision-making.","authors":"Jacquie Oliwa, Fatuma Hassan Guleid, Collins J Owek, Justinah Maluni, Juliet Jepkosgei, Jacinta Nzinga, Vincent O Were, So Yoon Sim, Abel W Walekhwa, Hannah Clapham, Saudamini Dabak, Sarin Kc, Liza Hadley, Eduardo Undurraga, Brittany L Hagedorn, Raymond Cw Hutubessy","doi":"10.1136/bmjopen-2024-093645","DOIUrl":"10.1136/bmjopen-2024-093645","url":null,"abstract":"<p><strong>Introduction: </strong>The COVID-19 pandemic highlighted the significance of mathematical modelling in decision-making and the limited capacity in many low-income and middle-income countries (LMICs). Thus, we studied how modelling supported policy decision-making processes in LMICs during the pandemic (details in a separate paper).We found that strong researcher-policymaker relationships and co-creation facilitated knowledge translation, while scepticism, political pressures and demand for quick outputs were barriers. We also noted that routine use of modelled evidence for decision-making requires sustained funding, capacity building for policy-facing modelling, robust data infrastructure and dedicated knowledge translation mechanisms.These lessons helped us co-create a framework and policy roadmap for improving the routine use of modelling evidence in public health decision-making. This communication paper describes the framework components and provides an implementation approach and evidence for the recommendations. The components include (1) funding, (2) capacity building, (3) data infrastructure, (4) knowledge translation platforms and (5) a culture of evidence use.</p><p><strong>Key arguments: </strong>Our framework integrates the supply (modellers) and demand (policymakers) sides and contextual factors that enable change. It is designed to be generic and disease-agnostic for any policy decision-making that modelling could support. It is not a decision-making tool but a guiding framework to help build capacity for evidence-based policy decision-making. The target audience is modellers and policymakers, but it could include other partners and implementers in public health decision-making.</p><p><strong>Conclusion: </strong>The framework was created through engagements with policymakers and researchers and reflects their real-life experiences during the COVID-19 pandemic. Its purpose is to guide stakeholders, especially in lower-resourced settings, in building modelling capacity, prioritising efforts and creating an enabling environment for using models as part of the evidence base to inform public health decision-making. To validate its robustness and impact, further work is needed to implement and evaluate this framework in diverse settings.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e093645"},"PeriodicalIF":2.4,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11973756/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787818","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":"Safety surveillance of respiratory syncytial virus (RSV) vaccine among pregnant individuals: a real-world pharmacovigilance study using the Vaccine Adverse Event Reporting System.","authors":"Abdallah Alami, Santiago Pérez-Lloret, Donald R Mattison","doi":"10.1136/bmjopen-2024-087850","DOIUrl":"10.1136/bmjopen-2024-087850","url":null,"abstract":"<p><strong>Objectives: </strong>To describe the post-marketing safety profile of respiratory syncytial virus prefusion F (RSVpreF) vaccine among pregnant individuals.</p><p><strong>Design: </strong>This study analysed adverse event (AE) reports submitted to the U.S. Food and Drug Administration's Vaccine Adverse Event Reporting System (VAERS) database following RSVpreF immunisation from 1 September 2023 to 23 February 2024.</p><p><strong>Setting: </strong>VAERS, as a national spontaneous vaccine safety surveillance system, provides insights into the safety profile of the RSVpreF vaccine in a real-world setting.</p><p><strong>Participants: </strong>Surveillance data included all AE reports submitted to VAERS in pregnant individuals following vaccination.</p><p><strong>Exposure: </strong>Receipt of RSVpreF vaccine among pregnant individuals in the USA.</p><p><strong>Primary and secondary outcome measures: </strong>Descriptive statistics were used to assess all AE reports with RSVpreF, including frequency, gestational age at vaccination, time to AE onset, reported outcomes and proportion of serious reports. Data mining techniques were employed to identify disproportionate reporting of RSVpreF-event pairs. Reports of preterm births were clinically reviewed.</p><p><strong>Results: </strong>VAERS received 77 reports pertaining to RSVpreF vaccination in pregnant individuals, with 42 (54.55%) classified as serious. The most frequently reported non-pregnancy-specific AEs were headache, injection site erythema and injection site pain. For pregnancy-specific AEs, preterm birth was the most frequently reported (12.8%), followed by AE terms such as preterm premature rupture of membranes and caesarean section (each at 3.3%), and cervical dilatation, haemorrhage during pregnancy and uterine contractions during pregnancy (each at 1.4%). Our disproportionality analysis indicated signals for various AEs, particularly preterm birth, indicating that reports of preterm birth in conjunction with RSVpreF vaccination were observed more frequently than statistically expected. Most of the reported preterm births were moderate to late, occurring between 32 and less than 37 weeks of gestation. The median time from immunisation to the onset of preterm birth was 3 days, with two-thirds of cases reported within a week of vaccination.</p><p><strong>Conclusions: </strong>The AEs reported to VAERS among pregnant individuals vaccinated with RSVpreF largely aligned with the safety profile observed in prelicensure studies; however, this analysis also highlights the previously observed safety signal for preterm birth. Active surveillance studies focusing on maternal and perinatal outcomes are needed to further evaluate this signal and guide future clinical recommendations.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e087850"},"PeriodicalIF":2.4,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11973799/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787844","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":"Smartphone-based ecological momentary music intervention to reduce stress in Turkish immigrant women: protocol.","authors":"Stefanie Hirsch, Urs M Nater, Ricarda Mewes","doi":"10.1136/bmjopen-2024-090518","DOIUrl":"10.1136/bmjopen-2024-090518","url":null,"abstract":"<p><strong>Background: </strong>Immigrant women frequently encounter ethnic discrimination (ED) and/or stressful events in their daily lives. To mitigate the risk of resulting health impairments, we developed an ecological momentary music intervention (EMMI-T) to reduce psychological and biological stress levels in the daily lives of Turkish immigrant women. The feasibility of the EMMI-T was confirmed in a pilot study (n=20). Here, we present the protocol of our proposed study to investigate the effectiveness of the EMMI-T.</p><p><strong>Methods: </strong>Fifty Turkish immigrant women perceiving chronic ED will take part in the 35-day study. During all three study periods (ie, baseline, intervention and post-intervention), participants will use a smartphone-based app to provide discrimination-related and stress-related data four times a day. Additionally, they will report every discriminatory and/or stressful event. During the intervention period, subsequently after such event-based data entries, participants will be allocated to either an intervention event (music listening for 10 or 20 min) or a control event (no music listening). Irrespective of event type, the app will signal 20 min after the initial event-based data entry for additional data collection. Every data entry will be accompanied by the collection of a saliva sample for analysis of biological stress markers (alpha-amylase, cortisol).</p><p><strong>Analysis: </strong>This intraindividual randomised design will allow us to test immediate (ie, before vs after music listening) and intermediate (ie, baseline period vs postintervention period) effects of the EMMI-T on psychological and biological stress levels. To test our hypotheses, we will use multilevel modelling.</p><p><strong>Ethics and dissemination: </strong>Positive ethical approval was given by the institutional review board of the University of Vienna (reference number 00575). The results of our study will be disseminated at conferences and submitted to a peer-reviewed journal.</p><p><strong>Trial registration number: </strong>NCT05829031.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e090518"},"PeriodicalIF":2.4,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11973758/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787858","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":"COVID-19 Early Detection in Doctors and Healthcare Workers (CEDiD) study: a cohort study on the feasibility of wearable devices.","authors":"Alexander Zargaran, Sara Sousi, Gary Colville, Gill Radcliffe, Rayka Malek, Abdel Douiri, Kariem El-Boghdadly, Gaia Nebbia, Rocio T Martinez Nunez, Anne Greenough","doi":"10.1136/bmjopen-2024-089598","DOIUrl":"10.1136/bmjopen-2024-089598","url":null,"abstract":"<p><strong>Background: </strong>Infectious agents such as SARS-CoV-2 require strategies to contain outbreaks, particularly in hospitals where the spread of infection is most likely. Biometric monitoring of heart rate, temperature, oxygen saturations and sleep might provide important early warning signs for SARS-CoV-2. This study aimed to determine whether a smart medical device (E4 wristband) and a pulse oximeter used to continuously measure heart rate, skin temperature and oxygen saturation would predict the onset of SARS-CoV-2 infection.</p><p><strong>Methods: </strong>A single-centre, prospective observational cohort of 30 healthcare workers (HCWs) working in areas at high risk for exposure to SARS-CoV-2 were enrolled. HCWs were tested for SARS-CoV-2 using RT-qPCR of daily self-administered swabs for 30 days. Each participant was asked to wear an E4 wristband to measure changes in their heart rate, skin temperature and sleep throughout the study.</p><p><strong>Results: </strong>Nine (30%) HCWs (median (range) age of 39 (27-57) years) tested positive for COVID-19. No significant differences were found in the pre-infection and post-infection variations in the heart rate (p=0.31) or skin temperature (p=0.44). Seven of the nine positive subjects reported symptoms at some point during the study period: unusual fatigue (40%), headache (33%) and runny nose (22%) were the most frequent. Analysis of daily trends in observations demonstrated significant fluctuations in biometric parameters.</p><p><strong>Conclusion: </strong>These results suggest that wearable technology might be useful in documenting signs of SARS-CoV-2 infection in exposed HCWs.</p><p><strong>Trial registration number: </strong>NCT04363489.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e089598"},"PeriodicalIF":2.4,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11973797/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787709","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":"'Transauricular vagus nerve stimulation' for prevention of postoperative delirium in elderly patients undergoing major surgery: a study protocol for a multicentre, participant-blinded and assessor-blinded, randomised, controlled trial.","authors":"Jun Zhang, Qi-Hong Shen, Xinru Lin, Tieshuai Liu, Yunyun Yu, Yu Li, Keqin Song, Xin Yu, Gang Chen","doi":"10.1136/bmjopen-2024-093647","DOIUrl":"10.1136/bmjopen-2024-093647","url":null,"abstract":"<p><strong>Introduction: </strong>Postoperative delirium (POD) is a frequent complication in elderly patients undergoing major surgery. Research has shown that neuroinflammation, postoperative pain and autonomic nervous system dysfunction play significant roles in its onset. Vagus nerve stimulation (VNS) has the potential to reduce inflammation, ease postoperative pain and aid in recovery by enhancing acetylcholine release and activating the cholinergic anti-inflammatory pathway. This study aims to assess the effectiveness and safety of transauricular VNS (ta-VNS) in preventing POD in elderly patients undergoing major surgery.</p><p><strong>Methods and analysis: </strong>This multicentre, participant-blinded and assessor-blinded, randomised, parallel-group controlled trial will compare the incidence of POD in elderly patients undergoing major surgery who receive ta-VNS versus sham stimulation. A total of 300 eligible patients will be randomly assigned in a 1:1 ratio to either the active or sham stimulation group. The active stimulation group will receive electrical stimulation to the left cymba conchae at a frequency of 30 Hz and a pulse width of 250 µs, with a 30 s on/30 s off cycle. The intensity will start at 0.4V and be increased in 0.4V increments until a tingling sensation is felt, then adjusted to the highest tolerable level without pain. After obtaining informed consent and randomisation, the initial intervention will begin in the preoperative area and continue throughout the surgery. For the four postoperative days, the intervention will be administered twice daily in 2-hour sessions each morning and afternoon. The sham group will follow the same procedure, with electrodes placed on the left cymba conchae. After adjusting the stimulation intensity, the device will be switched off. The primary outcome is the incidence of POD from postoperative day 0 to day 7 or discharge. Secondary outcomes include the severity of POD, quality of recovery, sleep quality and adverse events.</p><p><strong>Ethics and dissemination: </strong>The protocol was approved by Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine on 9 January 2024 (Approval number: 20240014), and the trial was registered on the Chinese Clinical Trial Registry on 21 February 2024, prior to recruitment. The study will be performed according to the guidelines of the Declaration of Helsinki. Written informed consent will be obtained from all participants. The results will be submitted for publication in a refereed journal.</p><p><strong>Trial registration number: </strong>ChiCTR2400081078.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e093647"},"PeriodicalIF":2.4,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11973790/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787861","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":"Lived experiences and insights of Chinese patients with symptomatic osteoporosis on a patient-reported outcome (PRO) programme: a qualitative phenomenological study in Southwest China.","authors":"Yao Chen, Yuehua Zhang, Qianlian Zheng, Lei Sun","doi":"10.1136/bmjopen-2024-087480","DOIUrl":"10.1136/bmjopen-2024-087480","url":null,"abstract":"<p><strong>Objectives: </strong>To explore the lived experiences of patients with symptomatic osteoporosis on a patient-reported outcomes (PROs) programme for symptom management and quality of life (QoL) improvement.</p><p><strong>Design: </strong>This is a qualitative phenomenological study.</p><p><strong>Setting: </strong>PARTICIPANTS: 14 active participants in the PROs programme were recruited and interviewed through semi-structured face-to-face interviews. Colaizzi's seven-step method was employed for thematic analysis.</p><p><strong>Results: </strong>Four overarching themes and two sub-themes emerged, including (1) varied perceptions of the PROs programme, where some participants found it beneficial for tracking symptoms while others cited challenges such as technological barriers and lack of actionable outcomes; (2) PROs as a tool for enhancing communication and facilitating appointments by enabling more efficient doctor-patient interactions and quicker scheduling; (3) emotional support provided by regular doctor-patient communication, with sub-themes of fostering a sense of belonging and offering psychological comfort; and (4) limitations of remote communication, highlighting challenges in addressing complex medical needs and providing immediate solutions for medication adjustments.</p><p><strong>Conclusions: </strong>PROs programmes facilitate symptom tracking, enhance communication and provide emotional support for patients with osteoporosis. However, limitations such as technological barriers and reliance on remote communication must be addressed. Ethical considerations, including potential over-reporting of symptoms to expedite care, require careful management. Future research should include patients who discontinue participating in the PROs programme prematurely and the perspectives of healthcare providers to provide a more balanced, comprehensive understanding.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e087480"},"PeriodicalIF":2.4,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969611/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779090","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":"Sensor-triggered ecological momentary assessment in physical activity and sedentary behaviour research among Belgian community-dwelling elderly: lessons learnt from intensive longitudinal studies.","authors":"Julie Delobelle, Elien Lebuf, Sofie Compernolle, Tomas Vetrovsky, Jelle Van Cauwenberg, Richard Cimler, Jitka Kuhnova, Delfien Van Dyck","doi":"10.1136/bmjopen-2024-096327","DOIUrl":"10.1136/bmjopen-2024-096327","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;Regular physical activity (PA) and reduced sedentary behaviour (SB) have been associated with positive health outcomes, but many older adults do not comply with the current recommendations. Sensor-triggered ecological momentary assessment (EMA) studies allow capturing real-time data during or immediately after PA or SB, which can yield important insights into these behaviours. Despite the promising potential of sensor-triggered EMA, this methodology is still in its infancy. Addressing methodological challenges in sensor-triggered EMA studies is essential for improving protocol adherence and enhancing validity. Therefore, this study aimed to examine (1) the patterns in sensor-triggered EMA protocol adherence (eg, compliance rates), (2) the impact of specific settings (eg, event duration) on the number of prompted surveys, and (3) participants' experiences with engaging in a sensor-triggered EMA study.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design: &lt;/strong&gt;Two longitudinal, sensor-triggered EMA studies-one focused on PA and the other on SB-were conducted using similar methodologies from February to October 2022. Participants' steps were monitored for seven days using a Fitbit activity tracker, which automatically prompted an EMA survey through the HealthReact smartphone application when specified (in)activity thresholds were reached. After the monitoring period, qualitative interviews were conducted. Data from both studies were merged.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Setting: &lt;/strong&gt;The studies were conducted among community-dwelling Belgian older adults.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Participants: &lt;/strong&gt;The participants had a median age of 72 years, with 54.17% being females. The PA study included 88 participants (four dropped out), while the SB study included 76 participants (seven dropped out).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Primary and secondary outcome measures: &lt;/strong&gt;Descriptive methods and generalised logistic mixed models were employed to analyse EMA adherence patterns. Simulations were conducted to assess the impact of particular settings on the number of prompted EMA surveys. Additionally, qualitative interview data were transcribed verbatim and thematically analysed using NVivo.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Participants responded to 81.22% and 79.10% of the EMA surveys in the PA and SB study, respectively. The confirmation rate, defined as the percentage of EMA surveys in which participants confirmed the detected behaviour, was 94.16% for PA and 72.40% for SB. Logistic mixed models revealed that with each additional day in the study, the odds of responding to the EMA survey increased significantly by 1.59 times (OR=1.59, 95% CI: 1.36 to 1.86, p&lt;0.01) in the SB study. This effect was not observed in the PA study. Furthermore, time in the study did not significantly impact the odds of participants confirming to be sedentary (OR=0.97, 95% CI: 0.92 to 1.02, p=0.28). However, it significantly influenced the odds of confirming PA (OR: 0.81, 95% CI: 0.68 to 0.97, p=0.02), wit","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 4","pages":"e096327"},"PeriodicalIF":2.4,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969600/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779138","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}