BMJ Open最新文献

{"title":"Uses of private health provider data for governance in low-income and middle-income countries: results from a scoping review.","authors":"Alix Faddoul, Dominic Montagu, Sneha Kanneganti, Barbara O'Hanlon","doi":"10.1136/bmjopen-2023-083096","DOIUrl":"https://doi.org/10.1136/bmjopen-2023-083096","url":null,"abstract":"<p><p>This work grew from an interest in understanding how private data are used for health system governance in low-income and middle-income countries (LMICs).</p><p><strong>Objective: </strong>We conducted a scoping review to understand how the public sector collects routine data from the private health sector and uses it for governance purposes. The private health sector was defined to include both formal and informal, for-profit or non-profit, actors delivering healthcare services.</p><p><strong>Findings: </strong>We identified 4014 individual English language studies published between 2010 and 2021. We reviewed titles and abstracts of all, with 50% reviewed by two authors to ensure a common application of inclusion criteria. 89 studies were selected for review in full; following this, 26 articles were included in the final selection as they directly report on the use of routine private sector data for governance in LMICs. Only English language studies were included, limiting the scope of possible conclusions.</p><p><strong>Results: </strong>Data were most commonly collected by the Ministry of Health or a subministerial office, with extraction from District Health Information System 2 specifically cited for three studies. 16 studies collected data on infrastructure and distribution, 15 on service delivery, 12 on health financing, 7 on pharmaceuticals and other consumables, 4 on health workforce, 4 on quality of care and 4 on epidemic surveillance.</p><p><strong>Conclusion: </strong>The studies identified provide examples of the public sector's capacity to collect and use data routinely collected from the private sector to perform essential governance functions. The paucity of studies identified is an indication that more attention is needed to ensure that this key area of health system governance is undertaken and that lessons learnt are shared. This review provides insights to understanding private sector health data collection and use for governance in LMICs, and for guiding activities to assess and improve this according to country context and capacity.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e083096"},"PeriodicalIF":2.4,"publicationDate":"2024-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142647034","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":"Exploring paruresis ('shy bladder syndrome') and factors that may contribute to it: a cross-sectional UK survey study.","authors":"Hayley Anne Hutchings, Abi Kehinde","doi":"10.1136/bmjopen-2024-086097","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-086097","url":null,"abstract":"<p><strong>Objectives: </strong>To assess the prevalence and severity of paruresis ('shy bladder syndrome') in a population of university staff and students and to determine if there was any relationship between demographics, self-esteem, presence of social anxiety disorders and negative toilet experiences and paruresis.</p><p><strong>Design: </strong>We undertook an anonymised cross-sectional online survey using Microsoft Forms. We invited participants aged 18 and over to complete the survey which included demographic information; any pre-existing medically or self-diagnosed anxiety-related conditions; Shy Bladder Scale (SBS); Rosenberg Self-Esteem Scale (RSES) and questions about using school toilets in their younger life. We defined 'mild' and 'severe' paruresis based on total SBS cut-off scores of greater than or equal to 31 and greater than or equal to 40. We calculated prevalence of paruresis, and explored differences in self-esteem, school toilet experience and social anxiety disorders between individuals with and without paruresis. Multivariable logistic regression was used to determine which variables had any influence on having a 'mild' and 'severe' paruresis diagnosis.</p><p><strong>Setting: </strong>We distributed the survey to all staff and students via their university email address as well as promoting the survey on university social media sites.</p><p><strong>Results: </strong>We received responses from 356 individuals. Most participants (237, 66.6%) were within the 18-30 year age category and most (277, 77.8%) were white. There were 221 (62.1%) females, 119 (33.4%) males and 16 (4.5%) other genders. The prevalence of 'mild' paruresis was 25.8% and of 'severe' paruresis 14.9% in this sample. 73.0% indicated that they had at least one medically or self-diagnosed anxiety disorder. There was a statistically significant difference in the total SBS score between individuals with and without an existing anxiety disorder (8 vs 19, <0.001). The adjusted odds of 'mild' paruresis were higher for men than women (OR 3.39; 95% CI 1.90 to 6.06), lower for those with a lower RSES score (OR 0.90; 95% CI 0.85 to 0.96), lower for those for a lower school toilet experience score (OR 0.88; 95% CI 0.78 to 0.99) and higher for those with at least one anxiety disorder (OR 3.164; 95% CI 1.52 to 6.59). The adjusted odds of 'severe' paruresis were higher for men than women (OR 2.60; 95% CI 1.32 to 5.12), lower for those with a lower RSES score (OR 0.90; CI 0.84 to 0.97) and higher for those with at least one anxiety disorder (OR 2.99 (1.18-7.56)).</p><p><strong>Conclusion: </strong>Large organisations should consider measures to help manage anxiety and improve toilet experiences. These could include resources and signposting to manage anxiety disorders and single-occupancy toilets and toilets in quiet areas to limit anxiety associated with shy bladder syndrome.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e086097"},"PeriodicalIF":2.4,"publicationDate":"2024-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142646926","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":"Pain during prolonged sitting in subjects with patellofemoral pain in Dutch physical therapy clinics: an online questionnaire-based analysis.","authors":"Martin Ophey, Sophie Frieling, Gino M M J Kerkhoffs, Igor Tak","doi":"10.1136/bmjopen-2024-086958","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-086958","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to describe (1) differences between subjects with patellofemoral pain (PFP) with and without pain during prolonged sitting (PDPS), (2) minimum knee flexion angle and time to onset/disappearance of PDPS and (3) differences between those with PDPS at smaller/greater flexion angles and with fast/slow onset and disappearance of PDPS.</p><p><strong>Design: </strong>Patient-reported online questionnaire.</p><p><strong>Setting: </strong>Private physical therapy clinics in the Netherlands between May 2021 and March 2023.</p><p><strong>Participants: </strong>87 participants (61 (70%) females, mean age 22.0 years (IQR 4.0), body mass index 23.1 (4.7)).</p><p><strong>Outcome measures: </strong>Visual Analogue Scale for worst pain (VAS-W) and sitting pain (VAS-W sitting), the Anterior Knee Pain Scale (AKPS), knee flexion angle to provoke PDPS and time to onset/disappearance of PDPS.</p><p><strong>Results: </strong>63 of 87 (72%) participants reported PDPS. Participants with PDPS experienced bilateral symptoms of PFP more frequently (71% vs 46%, p=0.44) and scored 12 points lower on the AKPS (p<0.001). Most participants (85%) reported a minimum knee flexion angle of ≥90°, median time to PDPS onset of 16-20 min and 6-10 min for disappearance. Participants experiencing PDPS at smaller flexion angles exhibited higher VAS-W and VAS-W sitting scores (7.0 (1.0), 6.8 (1.1)) than those at greater flexion angles (5.0 (3.0), for both) (p=0.002, p=0.001). Participants with fast onset of PDPS reported higher VAS-W and VAS-W sitting scores (7.0 (2.0), 6.0 (2.0)) than those with slow onset (5.0 (3.0), 5.0 (4.0)) (p<0.001, p=0.025).</p><p><strong>Conclusions: </strong>Participants with PDPS reported higher levels of disability than those without. PDPS was typically induced at knee flexion of ≥90°, with delayed onset/disappearance. Higher pain levels were reported by those experiencing PDPS at smaller knee flexion angles or with faster onset. Future research should explore the mechanisms of PDPS and develop targeted interventions to improve long-term outcomes.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e086958"},"PeriodicalIF":2.4,"publicationDate":"2024-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142646861","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":"Determinants of inpatient satisfaction and hospital recommendation: experiences from a cross-sectional study of a tertiary general hospital in China.","authors":"Xuedong Liu, Chenghong Lai, Mengliang Ye, Jiali Xie","doi":"10.1136/bmjopen-2024-086331","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-086331","url":null,"abstract":"<p><strong>Objectives: </strong>This study aims to investigate the satisfaction levels of inpatients and identify the determinants of inpatient satisfaction and hospital recommendations.</p><p><strong>Design: </strong>A cross-sectional study was conducted in 2022.</p><p><strong>Setting: </strong>A tertiary general hospital in Sichuan Province, China.</p><p><strong>Participants: </strong>271 inpatients were randomly selected and studied.</p><p><strong>Primary and secondary outcome measures: </strong>A tailored questionnaire was developed to measure inpatient satisfaction and hospital recommendation. T-test and analysis of variance were employed to compare the differences in inpatients' demographic characteristics across five satisfaction domains. Multivariate binary logistic regression was performed to identify determinants associated with inpatient satisfaction and hospital recommendation.</p><p><strong>Results: </strong>The mean inpatient satisfaction score was 4.27 and the mean hospital recommendation score was 3.96. Inpatients showed the highest satisfaction with the physician care domain and the lowest satisfaction with the hospital environment domain. Statistically significant differences were observed in inpatient demographic characteristics among specific satisfaction domains. Older inpatients, those with Urban Employees and Residents Medical Insurance, from the internal medicine department, and inpatients from the hospital's older region reported the highest levels of satisfaction. Multivariate binary logistic regression revealed that the nursing care domain was the strongest positive predictor of both inpatient overall satisfaction and hospital recommendation. Additionally, the medical procedure and hospital environment domains were strong positive predictors for hospital recommendation and inpatient overall satisfaction respectively. The hospital region domain was a strong negative predictor for inpatient overall satisfaction.</p><p><strong>Conclusions: </strong>Higher satisfaction levels do not necessarily correlate with an increased likelihood of hospital recommendation. Inpatient satisfaction levels vary significantly based on factors such as age, gender, insurance type, hospital clinical department and region. The domains of nursing care and medical procedure are the influencing factors associated with inpatient overall satisfaction. The domains of nursing care, hospital environment and hospital region are the influencing factors of inpatient hospital recommendation.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e086331"},"PeriodicalIF":2.4,"publicationDate":"2024-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142646903","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":"Effects of using wearable devices on reducing sedentary time and prolonged sitting in healthy adults: a network meta-analysis.","authors":"Zihao He, Guanggao Zhao, Chao Li, Yachen Xing, Anjie Xu, Junchao Yang, Ronghui Wang","doi":"10.1136/bmjopen-2023-080186","DOIUrl":"https://doi.org/10.1136/bmjopen-2023-080186","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to compare the effectiveness of different wearable intervention strategies in reducing sedentary time (ST) and prolonged sitting (PS) on healthy adults.</p><p><strong>Design: </strong>A network meta-analysis (NMA).</p><p><strong>Data sources: </strong>PubMed, Web of Science, SPORTDiscus, ProQuest, Opengrey, Medline and Cochrane Central Register of Controlled Trials were searched up to 1 June 2024.</p><p><strong>Eligibility criteria for selecting studies: </strong>Randomised controlled trials (RCTs) that examined the effect of wearable device interventions on ST and PS among healthy adults were included.</p><p><strong>Data extraction and synthesis: </strong>Two independent reviewers used standardised methods to search, screen and code included studies. Bias risks were assessed using Cochrane tools (Risk of Bias 2.0). Data were analysed using a frequentist framework NMA to directly and indirectly compare the effects of the five different intervention strategies (comparators). The results were reported as standardised mean differences (SMDs) with 95% CI and surface under cumulative ranking curve (SUCRA) was used to rank the best interventions. The five comparators were as follows: (1) wearable-only intervention (only using wearable devices for self-monitoring); (2) wearable combined with online intervention (ie, online coaching and social media support); (3) wearable combined with offline intervention (ie, face-to-face seminars and courses); (4) comparison group (ie, traditional, non-wearable interventions); (5) control group (ie, maintaining daily routine, waitlist).</p><p><strong>Results: </strong>12 RCTs with a total of 2957 participants were included. Results of NMA showed that the 'wearable+online' has significantly better effects in reducing ST compared with control group, comparison group and 'wearable only', with moderate to large effect sizes (SMD=0.96, 95% CI 0.65 to 1.27; SMD=0.87, 95% CI 0.21 to 1.53; SMD=0.78, 95% CI 0.14 to 1.42, respectively). However, no significant differences were identified between the groups in reducing PS. The SUCRA values were ranked as wearable+online (98.1%), wearable+offline (64.4%,), 'wearable only' (40.5%), comparison group (25.9%) and control group (21.1%) for ST reduction. Similar rankings were observed for PS reduction, with probabilities of 69.9%, 61.1%, 59.7%, 37.1% and 22.1%, respectively.</p><p><strong>Conclusions: </strong>Wearable+online is the best intervention strategy for reducing ST in healthy adults. Additionally, none of the wearable-based interventions effectively reduced PS in healthy adults, but as there is little research on PS, it should receive more attention in the future. <b>PROSPERO registration number:</b> CRD42021290017.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e080186"},"PeriodicalIF":2.4,"publicationDate":"2024-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142646914","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":"Immunogenicity of adalimumab reference product and adalimumab-adbm in patients with rheumatoid arthritis, Crohn's disease and chronic plaque psoriasis: a pooled analysis of the VOLTAIRE trials.","authors":"Vibeke Strand, Dorothy McCabe, Shaun Bender","doi":"10.1136/bmjopen-2023-081687","DOIUrl":"10.1136/bmjopen-2023-081687","url":null,"abstract":"<p><strong>Objective: </strong>This post hoc analysis compared the immunogenicity of the biosimilar adalimumab-adbm (Cyltezo) with the adalimumab reference product (RP; Humira) across indications, including rheumatoid arthritis (RA), Crohn's disease (CD) and plaque psoriasis (PsO), and by patient sex in the VOLTAIRE trials programme.</p><p><strong>Methods: </strong>In each active-comparator randomised controlled trial (RCT), immunogenicity was assessed at various time points by the proportion of patients with antidrug antibodies (ADAs) and neutralising antibodies (nAbs), using acid dissociation followed by electrochemiluminescence assay. Assay sensitivity was 50 ng/mL, and drug tolerance was ≥30 µg/mL (free drug) at the low positive control level.</p><p><strong>Results: </strong>Minor differences in immunogenicity parameters (ADAs, ADA titres and nAbs) were evident between adalimumab-adbm and adalimumab RP across these three immune-mediated inflammatory diseases (IMIDs). The proportion of ADA-positive and nAb-positive patients increased from baseline over time in all three RCTs, as expected, and was similar in the RA and CD RCTs but with higher numbers of ADA-positive and nAb-positive patients reported in the PsO trial. Subgroup analysis by patient sex showed the same trend.</p><p><strong>Conclusions: </strong>Differences among the RCTs may partially be explained by concomitant background therapy (methotrexate) in the RA trial, stable doses of azathioprine, 6-mercaptopurine or methotrexate in 36% of patients with CD and absence of background therapy in the PsO RCT. The analyses further confirm the biosimilarity of adalimumab-adbm with the adalimumab RP across IMIDs and provide supporting evidence that adalimumab-adbm is an interchangeable biosimilar with consistent clinical results in patients originally treated with the RP.</p><p><strong>Trial registration numbers: </strong>VOLTAIRE-RA (NCT02137226; EudraCT 2012-002945-40); VOLTAIRE-CD (NCT02871635; EudraCT 2016-000612-14); VOLTAIRE-PsO (NCT02850965; EudraCT 2016-000613-79).</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e081687"},"PeriodicalIF":2.4,"publicationDate":"2024-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142646937","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":"The Empty Office: protocol for sequential mixed-method study on the impact of telework activities on social relations and well-being.","authors":"Mattia Vacchiano, Guillaume Fernandez, Eric Widmer, Melanie Arntz, Manal Azzi, Abdi Bulti, Nicola Cianferoni, Stéphane Cullati, Sander Junte, Koorosh Massoudi, Oscar Molina Romo, Ana Catalina Ramirez, Stephanie Steinmetz","doi":"10.1136/bmjopen-2024-089232","DOIUrl":"10.1136/bmjopen-2024-089232","url":null,"abstract":"<p><strong>Introduction: </strong>Teleworking is one of the most significant legacies of the pandemic. Great attention is now being paid to its effects on workers' health. One of the arguments that emerged on this issue is that 'working away from the office' affects the time we spend with significant others. This calls into question all those processes that make relatives and colleagues important to our health, such as forms of mentoring and social support, but also conflicts, work interruptions or control over workers' activities. So far, no study has evaluated the impact that teleworking has on these processes using data on personal networks. <i>The Empty Office</i> is the first study to use social network analysis to measure the impact that telework has on social relations and, in turn, workers' health and well-being.</p><p><strong>Methods and analysis: </strong>The project draws on a total sample of 4400 participants from Switzerland, the Netherlands, Spain and Germany (n=1100 per country). The choice of these countries is due to their specificity and diversity in socioeconomic features, which make them particularly interesting for studying teleworking from a comparative point of view. The research is conceived as a sequential mixed-method design. First, quantitative data collection will administer an online questionnaire to gather information on telework modalities, health and well-being markers, and data on personal networks collected by a name generator. A qualitative module, administered one year later, will consist of in-depth interviews with a subsample (n=32) of teleworkers selected for delving narratively into the mechanisms identified with the quantitative analyses.</p><p><strong>Ethics and dissemination: </strong>This study has obtained 2 years of funding from the Swiss Network for International Study and was approved by the Ethics Committee of the University of Geneva (CUREG-20230920-292-2). All participants will be asked to provide informed consent to participate in this study. The results will be shared with international organisations and disseminated in scientific journals and conferences. Fully anonymised data will be made available on the Open Science Framework (OSF) data-repository platform.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e089232"},"PeriodicalIF":2.4,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614955","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":"Effect of different durations of preoperative computerised cognitive training on postoperative delirium in older patients undergoing cardiac surgery: a study protocol for a prospective, randomised controlled trial.","authors":"Xinyuan Qiu, Lili Wang, Xinge Wen, Qingling Meng, Junwei Qi, Chuang Li, Hua Yin, Fei Ling, Qiao Yuhan, Wen Zhang, Yueying Zhang","doi":"10.1136/bmjopen-2024-088163","DOIUrl":"10.1136/bmjopen-2024-088163","url":null,"abstract":"<p><strong>Introduction: </strong>Postoperative delirium (POD) is a common neurological complication after surgery among older patients, characterised by acute disturbances in consciousness, attention and cognition, usually occurring within 24-72 hours after surgery. POD has a significant impact on the prognosis of older patients undergoing major cardiovascular surgery, including increased length of hospital stay, hospital costs and readmission rates, with an incidence rate as high as 26%-52%. Computerised cognitive training (CCT) refers to difficulty-adaptive training in cognitive domains such as attention, memory and logical reasoning, using systematically designed tasks. Existing studies have shown that CCT has reduced the risk of delirium in non-cardiac surgery patients with at least minimal compliance. The purpose of this study is to investigate the effects of preoperative CCT on the incidence of POD in older patients undergoing elective cardiac surgery, to clarify the dose-effect relationship between different training time of preoperative CCT and POD and to explore the minimum effective time target that can significantly lower the incidence of POD.</p><p><strong>Methods and analysis: </strong>This is a prospective, single-blind, randomised controlled trial that aims to enrol 261 older patients scheduled for elective cardiac surgery at the Affiliated Hospital of Xuzhou Medical University. The patients will be randomised into three groups: group C will be the routine care group (no CCT prior to surgery); group L will be the low-dose time group (with a total of 5 hours of CCT prior to surgery) and group H will be the high-dose time group (with a total of 10 hours of CCT prior to surgery). The primary outcome is the incidence of delirium within 7 days after surgery. Secondary outcomes include postoperative mild neurocognitive disorder (NCD) and postoperative major NCD (30 days up to 1 year), time of onset and duration and severity of delirium, and all-cause mortality within 1 year after surgery. The results of this study are of significant importance for establishing effective, patient-centred and low-risk prevention strategies for POD/postoperative NCD.</p><p><strong>Ethics and dissemination: </strong>This study protocol has been approved by the Ethics Committee of the Affiliated Hospital of Xuzhou Medical University (Ethics Number: XYFY2023-KL149-01). All participants will provide written informed consent, and the results of the study will be published in international peer-reviewed academic journals and presented at academic conferences.</p><p><strong>Trial registration number: </strong>ChiCTR2300072806.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e088163"},"PeriodicalIF":2.4,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614869","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":"Completion and reporting of COVID-19 clinical trials registered on ClinicalTrials.gov during the first 6 months of the pandemic: cohort study.","authors":"Per Tornhammar, Alexander Julner, Nader Al Moosawi, Elin Wicksell, Carl-Emil Lim, Daniel Peter Andersson, Peter Ueda","doi":"10.1136/bmjopen-2024-085906","DOIUrl":"10.1136/bmjopen-2024-085906","url":null,"abstract":"<p><strong>Background: </strong>Early in the COVID-19 pandemic, numerous clinical trials were initiated. Although concerns were raised regarding the quality of the trials, the eventual research output yielded from the trials remains unknown. The objective of this study was to include all clinical trials registered on ClinicalTrials.gov during the first 6 months of the pandemic and assess if and where their results had been reported, their completion and discontinuation rates, achieved enrolment and changes made to the primary outcome after trial registration.</p><p><strong>Methods: </strong>We included all interventional studies related to COVID-19 first registered on ClinicalTrials.gov between 1 January 2020 and 1 July 2020. We systematically searched for trial results, reported through 15 May 2023, in scientific publications, preprints and ClinicalTrials.gov. We assessed the achieved trial enrolment, trial discontinuation (reaching <90% of target enrolment), and whether the primary outcome had been changed as compared with the initial protocol registration.</p><p><strong>Results: </strong>The 775 clinical trials included in the analysis planned to enrol 238 933 (median (IQR) 120 (60, 304) patients; 355 (46%) of the trials had reported results, and 283 (36%) were published in a scientific journal. In the reported trials, the total enrolment was 95 332 (median (IQR) 105 (45, 222) patients. 186 (24%) trials were completed, and 169 (22%) trials were discontinued, with slow recruitment being the most stated reason for discontinuation (9% of all trials, although 30% of the discontinued trials did not report a reason). 117 (33%) of the reported trials had changed their primary outcome. In total, 157 (20%) trials were completed and published in a scientific journal, of which 105 enrolled ≥100 patients and 103 had not changed the primary outcome. 63 completed and published trials enrolled ≥100 patients and had not changed the primary outcome.</p><p><strong>Conclusions: </strong>Most clinical trials of COVID-19 registered at ClinicalTrials.gov during the first 6 months of the pandemic remained unreported or had been discontinued. Many of the trials whose results had been reported enrolled few patients and changed the primary outcome after trial registration.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e085906"},"PeriodicalIF":2.4,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614735","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":"Analysis of clinical characteristics and risk factors on serrated polyps with synchronous advanced adenoma in elderly and non-elderly people: a retrospective cohort study.","authors":"Tianyu Chi, Ying Liu, Cuicui Yang, Qing Jia, Quchuan Zhao","doi":"10.1136/bmjopen-2024-083930","DOIUrl":"10.1136/bmjopen-2024-083930","url":null,"abstract":"<p><strong>Objectives: </strong>Serrated polyps (SPs) with synchronous advanced adenoma (AA) may increase the incidence of colorectal cancer. However, current studies do not address this combination of SPs and AAs in detail with regard to their clinical characteristics in different age groups. The aim was to assess clinical characteristics and risk factors for SPs with synchronous AA in different age groups.</p><p><strong>Design: </strong>Retrospective cohort study.</p><p><strong>Setting: </strong>Electronic medical record data from January 2011 to January 2022 at three grade III class A hospitals were enrolled in the study.</p><p><strong>Participants: </strong>A total of 1605 patients with SPs with synchronous AA, including 484 patients in the elderly group and 1121 patients in the non-elderly group, were studied.</p><p><strong>Main exposure measure: </strong>The elderly group and the non-elderly group.</p><p><strong>Main outcome measure: </strong>Sex, smoking history, drinking history, body mass index (BMI), SP location, size, morphology and pathology.</p><p><strong>Results: </strong>The incidence of hyperplastic polyps (HPs) with synchronous AA in the elderly group was higher than that in the non-elderly group, while the incidence of sessile serrated adenomas/polyps (SSAs/Ps) with synchronous AA in the non-elderly group was higher than that in the elderly group. Male sex, drinking history and HP size (≤20 mm) were independent risk factors for HPs with synchronous AA in the non-elderly group, while drinking history and HP size (≤15 mm) were independent risk factors in the elderly group. For SSAs/Ps with synchronous AA, male sex, smoking history, drinking history, and SSA size (≥16 mm) were independent risk factors in the non-elderly group; high BMI was an independent risk factor in the elderly group.</p><p><strong>Conclusions: </strong>SPs with synchronous AA showed different clinical characteristics and risk factors in different age groups.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e083930"},"PeriodicalIF":2.4,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614633","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}