Journal of Evidence‐Based Medicine最新文献

{"title":"Key Insights From a Rapid Review of Nondental Procedural Sedation Clinical Practice Guidelines for Adults With Intellectual and Developmental Disability","authors":"Andrea Simpson, Jessica Smith, Matthew Yates, Hannah Barden, Cassandra Gorton, Michelle Templeton","doi":"10.1111/jebm.70003","DOIUrl":"https://doi.org/10.1111/jebm.70003","url":null,"abstract":"<p>People with intellectual and developmental disabilities (IDD) experience significantly higher rates of physical and mental health conditions compared to the general population [<span>1, 2</span>]. This group also faces substantial barriers to accessing healthcare, often leading to unmet health needs and poor health outcomes [<span>3</span>]. For many people with IDD, routine clinical procedures, such as blood tests or immunizations, can be distressing [<span>4</span>]. This distress may stem from past trauma, complex communication needs, insufficient adjustments for sensory sensitivities, needle phobia, or the lack of accessible information about medical procedures [<span>5</span>]. As a result, it is not uncommon for clinicians to delay or abandon medical interventions for this population, placing individuals at risk for vaccine-preventable diseases and delays in diagnosing or managing health conditions [<span>6</span>].</p><p>For this reason, people with IDD can require procedural modifications for routine medical procedures, such as blood tests and immunizations. A range of nonpharmacological interventions, such as graduated exposure [<span>7</span>] and distractions using auditory or visual stimuli [<span>8</span>], have been proposed. For individuals who experience heightened anxiety during minor procedures, pharmacological interventions like sedation may be necessary.</p><p>Clinical practice guidelines (CPGs) for sedation in this population are limited, especially outside of dental care. We carried out a rapid review aimed to identify and assess existing CPGs for procedural sedation in adults with IDD. The review followed the rapid review guidelines of the Agency for Healthcare Research and Quality [<span>9</span>]. A PICO framework guided the review question, focusing on CPGs for procedural sedation (excluding dental care) in adults with IDD. Electronic searches were conducted across MEDLINE, Embase, Emcare, PsycINFO, and Scopus. Study selection and data extraction were carried out by two reviewers with disagreements resolved by a third. The AGREE II tool [<span>10</span>] was employed to assess the quality of the included guidelines. Data were extracted from 9 studies on study characteristics, procedural models of care, and key patient safety outcomes, including procedure completion rates, adverse side effects, and escalation in sedation dosage or type.</p><p>The 9 studies originated from several countries, including the United Kingdom (<i>n</i> = 3), the United States (<i>n</i> = 5), Australia (<i>n</i> = 1), and Italy (<i>n</i> = 1). The clinical procedures across the studies ranged from premedication, behavioral strategies, desensitization programs, to virtual reality exposure therapy. Clinical qualifications varied, with most procedures involving a multidisciplinary team that included anesthetists, nurses, psychologists, behavioral therapists, and other healthcare professionals, depending on the intervention's nature. The reviewed ","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"18 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jebm.70003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424289","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prognostic Significance of Hypophosphatemia in Kidney Transplant Patients: A Systematic Review and Meta-Analysis","authors":"Nipith Charoenngam, Thanitsara Rittiphairoj, Pitchaporn Yingchoncharoen, Chalothorn Wannaphut, Thanathip Suenghataiphorn, Thitiphan Srikulmontri, Phuuwadith Wattanachayakul, Nutchapon Xanthavanich","doi":"10.1111/jebm.70000","DOIUrl":"https://doi.org/10.1111/jebm.70000","url":null,"abstract":"<p>Hypophosphatemia is a common electrolyte disorder in kidney transplant (KT) patients, occurring in up to 93% of cases. This condition is mediated by persistent hyperparathyroidism and elevated serum fibroblast growth factor-23 (FGF-23) due to long-standing phosphate retention, leading to increased phosphaturia when the kidney's intrinsic ability to handle phosphate normalizes [<span>1</span>]. In severe cases, hypophosphatemia can lead to muscle weakness, cardiomyopathy, hemolytic anemia and respiratory failure [<span>1</span>]. However, the clinical significance of hypophosphatemia in milder cases is less well-established. Interestingly, some studies have shown that the presence of hypophosphatemia in KT patients indicated a favorable prognosis, including decreased risks of graft failure, mortality and cardiovascular disease (CVD) [<span>2, 3</span>]. Other studies, however, demonstrated a U-shaped association between serum phosphate levels and adverse outcomes [<span>4, 5</span>]. Therefore, using systematic review and meta-analysis techniques, we aimed to summarize all available data to investigate the association between hypophosphatemia and various clinical outcomes, including graft failure, all-cause mortality, cardiovascular mortality and CVD.</p><p>Three investigators (T.S., T.S., C.W.) independently searched publications indexed in PubMed and Embase databases from inception to March 27, 2024. Search terms were based on terms associated with “hypophosphatemia” and “kidney transplant.” No language restrictions were applied. The detailed search strategy is provided in Supplemental Material 1.</p><p>Eligible studies must include a cohort of KT patients with hypophosphatemia and a comparator cohort of KT patients without hypophosphatemia, excluding those with hyperphosphatemia. These studies should compare the risk of incident clinical outcomes, including all-cause mortality, cardiovascular mortality, CVD, and graft failure. Effect estimates and 95% confidence intervals (CIs) representing the risk ratio of incident outcomes between KT patients with and without hypophosphatemia must be reported. Studies that reported the association between serum phosphate as a continuous variable and clinical outcomes were deemed ineligible, as this association may be influenced by the effect of hyperphosphatemia.</p><p>The eligibility of the retrieved articles was evaluated by three investigators (P.Y., N.X., P.W.). Any discrepancies in evaluation were resolved through discussions with the senior investigator (N.C.). The quality of each study was assessed by two investigators (N.C. and P.Y.) using the Newcastle-Ottawa Quality Assessment Scale (NOS) for cohort studies.</p><p>Meta-analyses were performed for outcomes reported by at least four studies. Effect estimates with standard errors were extracted from each included study. The extracted data were combined together using the generic inverse variance method as described by DerSimonian and Laird. Since t","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"18 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jebm.70000","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424290","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sodium Characteristic Curve Predicts Mortality Risk in Hospitalized Patients: A Retrospective Cohort Study","authors":"Siyu Liang, Lize Sun, Nan Jiang, Yuelun Zhang, Hanze Du, Shi Chen, Hui Pan","doi":"10.1111/jebm.12676","DOIUrl":"https://doi.org/10.1111/jebm.12676","url":null,"abstract":"","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"18 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143389179","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Extraversion and the Brain: A Coordinate-Based Meta-Analysis of Functional Brain Imaging Studies on Positive Affect","authors":"Qianqian Tian,&nbsp;Qingyuan Li,&nbsp;Han Lai,&nbsp;Aniruddha Shekara,&nbsp;Jingguang Li,&nbsp;Song Wang","doi":"10.1111/jebm.12675","DOIUrl":"10.1111/jebm.12675","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Extraversion is a fundamental personality dimension that contributes to an individual's overall health and well-being. Many studies have examined the neural bases of extraversion but these results are inconsistent. This study adopted a meta-analysis approach to examine the brain activity correlates of extraversion by incorporating functional neuroimaging studies in the context of positive affect/emotional stimuli.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A systematic literature search was performed in the databases of PubMed, Web of Science Core Collection, Embase, PsycInfo, CNKI, WanFang, and Weipu. The demographic characteristics and basic information of the included studies were first summarized. Then, a meta-analysis was conducted using anisotropic effect-size seed-based <i>d</i> mapping. Jackknife sensitivity analysis was next conducted to examine the reliability of the findings. Finally, meta-regression analysis was performed to test the potential demographic effects (i.e., sex and age) on the association between extraversion and brain activity.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 11 studies were included in the meta-analysis. The results of meta-analysis revealed robust and consistent positive correlations between extraversion and activation of right inferior frontal gyrus/insula, right angular gyrus, and left precentral gyrus during positive affect processing. In contrast, brain activity in the right striatum during positive affect processing was negatively associated with extraversion. Additionally, meta-regression analysis revealed sex as a moderator in the relationship between extraversion and right insular activation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Overall, our study is the first to provide a comprehensive understanding of functional brain activation patterns of extraversion, which may be helpful for targeting of specific brain regions in personalized interventions for extraversion-related psychological/physical illness.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"18 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143059347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characteristics of Quality Improvement Projects in Health Services: A Systematic Scoping Review","authors":"Hanan Khalil,&nbsp;Caroline de Moel-Mandel,&nbsp;Deeksha Verma,&nbsp;Kathryn Kynoch,&nbsp;Ritin Fernandez,&nbsp;Mary-Anne Ramis,&nbsp;Jessica E. Opie","doi":"10.1111/jebm.12670","DOIUrl":"10.1111/jebm.12670","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Current QI reports within the literature frequently fail to provide enough information regarding interventions, and a significant number of publications do not mention the utilization of a guiding model or framework. The objective of this scoping review was to synthesize the characteristics of hospital-based QI interventions and assess their alignment with recommended quality goals.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This scoping review followed the JBI methodology for scoping reviews to synthesize existing literature on hospital-based QI interventions and reporting using the PRISMA Extension for scoping reviews. Included studies involved a hospital-based QI intervention that was evaluated through the Development of the Quality Improvement Minimum Quality Criteria Set (QI-MQCS) framework, reporting on hospital users' (i.e., practitioners and patients) data. We searched Medline, CINAHL, Embase and PubMed databases for primary research published between 2015 and 2024. Grey literature was also examined. A narrative synthesis guided the integration of findings.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>From 1398 identified records, 70 relevant records were included. Results indicate a wide variation in QI frameworks and methods used by the included studies. The QI interventions most frequently assessed were organizational-focused (<i>n</i> = 59), followed by professional-related interventions (<i>n</i> = 41) and patient-care interventions (<i>n</i> = 24). There were multiple facilitators and barriers across organizational, professional, and patient care levels found in the included studies. Examples of facilitators were instrumental in driving successful QI initiatives included education, training, active leadership, and stakeholder engagement. Conversely, barriers such as time constraints, resource limitations, and resistance were highlighted.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Existing QI publications lack sufficient detail to replicate interventions. Using a model or framework to guide the conduct of a QI-activity may support a more robustly designed and well-conducted project. The variation of reporting characteristics suggests that future research should focus on the development of a pragmatic tool for use by front-line clinicians to support consistent and rigorous conduct of QI projects.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"18 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jebm.12670","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143006719","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Practice Guidelines for Topical NSAIDs in the Treatment of Sports Injuries","authors":"Yan Xiong,&nbsp;Yan Liu,&nbsp;Jingbin Zhou,&nbsp;Xiliang Shang,&nbsp;Hongchen He,&nbsp;Guoping Li,&nbsp;Shiyi Chen,&nbsp;Jian Li","doi":"10.1111/jebm.12661","DOIUrl":"10.1111/jebm.12661","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> ABSTRACT</h3>\u0000 \u0000 <p>Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat sports injuries, but evidence-based medical guidance for their standardized and rational use is lacking. This guideline working group identified clinically important issues, obtained the full opinions of patients and clinical staff, and discussed them with the expert group. Based on evidence from the literature, the “clinical practice guidelines for topical NSAIDs in the treatment of sports injuries” were formulated following the methods and principles of international guidelines. According to these guidelines, 7 clinical concerns were ultimately selected, and 22 recommendations were formed. These included the status, indications, contraindications, efficacy, combined application, use in special populations, adverse reactions, and countermeasures of topical NSAIDs in the treatment of sports injuries. The purpose of these guidelines is to provide evidence-based recommendations for practitioners in the fields of orthopedics, sports medicine, rehabilitation medicine, and sports science, as well as other fields, in the treatment of sports injuries to promote more standardized and rational use of topical NSAIDs.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"18 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jebm.12661","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142950076","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevalence and Cardio-Renal Comorbidities of Masked Hypertension: A Meta-Analysis","authors":"Hailan Zhu,&nbsp;Jiahuan Li,&nbsp;Lingxiao Li,&nbsp;Xiaoyan Liang,&nbsp;Chunyi Huang,&nbsp;Xiaoyan Cai,&nbsp;Yuli Huang,&nbsp;Yanchang Huo","doi":"10.1111/jebm.12672","DOIUrl":"10.1111/jebm.12672","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aim</h3>\u0000 \u0000 <p>The prognosis of masked hypertension is controversial. The aims of this meta-analysis were to determine the global prevalence of masked hypertension and to better understand its association with the risk of cardiorenal comorbidities and all-cause mortality.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We searched the PubMed, Embase (OVID), The Cochrane Library, WanFang Data, and CNKI databases for relevant studies published from inception until January 15, 2024. Cohort studies that reported an association of masked hypertension with the risk of cardiorenal comorbidities and all-cause mortality were eligible for meta-analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Twenty-six studies (with 129,061 participants) were included. The median follow-up duration was 7.38 years. The pooled prevalence of masked hypertension was 18% (95% confidence interval [CI] 15%–21%). Compared with normotensive individuals, those with masked hypertension had an increased risk of all-cause mortality (relative risk [RR] 1.64, 95% CI 1.32–2.04) and incident cardiovascular disease (RR 1.57, 95% CI 1.45–1.69). The results were similar regardless of treatment status and in multiple subgroup analyses. Masked hypertension was also associated with increased risks of cardiovascular mortality (RR 1.69, 95% CI 1.02–2.78) and composite renal outcomes (RR 3.57, 95% CI 2.32–5.50).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Masked hypertension is prevalent in adults and associated with increased risks of all-cause mortality, cardiovascular disease, cardiovascular mortality, and composite renal events.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 4","pages":"833-842"},"PeriodicalIF":3.6,"publicationDate":"2024-12-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142895155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Percutaneous Transhepatic Cholangioscopy in Hepatolithiasis Associated With Decompensated Cirrhosis: A Retrospective Cohort Study","authors":"Qianyu Yan,&nbsp;Jie Zhang,&nbsp;Rui Chen,&nbsp;Jingyi Zhang,&nbsp;Rongxing Zhou","doi":"10.1111/jebm.12673","DOIUrl":"10.1111/jebm.12673","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Multiple and complicated hepatolithiasis can be associated with decompensated cirrhosis. Endoscopic retrograde cholangiopancreatography is unavailable for multiple and complicated hepatolithiasis, and the mainstay for decompensated cirrhosis is liver transplantation. However, due to the ethical factors and the complexity of operation, liver transplantation cannot be widely operated. This study aimed to evaluate percutaneous transhepatic cholangioscopy in the extraction of stones and the recompensation of cirrhosis in patients with hepatolithiasis associated with decompensated cirrhosis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Between January 2021 and February 2024, we retrospectively reviewed the clinical data of 21 patients with multiple and complicated hepatolithiasis associated with decompensated cirrhosis. Before PTCS, the 21 patients were all assessed by the Model for End-stage Liver Disease as having indications for liver transplantation. One-step PTCS (<i>n</i> = 19) and two-step PTCS (<i>n</i> = 2) were used to remove the stones.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The technical success rate was 100%, and most stones were cleared 90.48% (19/21). After 3 months of PTCS, MELD score of the patients had significantly decreased (10.81 ± 3.31 vs. 17.24 ± 3.40, <i>p</i> &lt; 0.05), and it was lowest at 6 months after the operation (9.94 ± 4.31). After a median follow-up period of 18 months (up to 40 months), the stone recurrence rate was 28.57% (6/21), 13 patients survived without liver transplantation, three patients underwent liver transplantation and survived, and five patients died of liver failure or cancer (mortality rate 23.81%).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>PTCS can significantly improve patients’ liver function in hepatolithiasis associated with decompensated cirrhosis.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 4","pages":"843-850"},"PeriodicalIF":3.6,"publicationDate":"2024-12-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142895037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Barriers and Facilitators to the Participation of Pregnant Women in Clinical Research: A Mixed-Methods Systematic Review","authors":"Yicheng Gao,&nbsp;Zijin Yu,&nbsp;Xinyu Zeng,&nbsp;Yixuan Guo,&nbsp;Zikun Liu,&nbsp;Xinyi Yan,&nbsp;Tiantian Guo,&nbsp;Chuanya Yan,&nbsp;Zhihan Liu,&nbsp;Yutong Fei","doi":"10.1111/jebm.12663","DOIUrl":"10.1111/jebm.12663","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>Pregnant women had a large demand for diagnosis and treatment, but the clinical research was not sufficient, and there were many barriers for pregnant women to participate in clinical research. This study aimed to systematically identify these barriers and facilitators, map them with Theoretical Domains Framework (TDF) and Behavior Change Techniques (BCTs) to inform the development of interventions promoting pregnant women's involvement in clinical research.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This was a mixed-methods systematic review. PubMed, Embase, Cochrane Library, APA PsycInfo, CINAHL, China National Knowledge Infrastructure, WanFang, VIP Database for Chinese Technical Periodicals, Chinese Biomedical Literature Database, and related references were searched. Qualitative, quantitative, and mixed-methods studies exploring barriers and facilitators to pregnant women's participation in clinical trials were included. The barriers and facilitators were extracted, after transforming the quantitative data into qualitative data, all qualitative data were used to thematic synthesis. The identified barriers and facilitators were mapped into TDF and BCTs.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 103 studies (66 qualitative, 24 quantitative, and 13 mixed-methods) were included. Three main themes were formed: personal factors, environmental factors and research characteristics, with identified barriers and facilitators within each theme. “Knowledge,” “Environmental Context and Resources,” and “Beliefs about Consequences” were the main domains where barriers and facilitators identified by pregnant women and researchers were mapped in TDF. Additionally, the barriers and facilitators identified by pregnant women also mapped on “Social Influences” and “Goals.” “Instruction on how to perform a behavior,” “restructuring the physical environment,” “salience of consequences,” “social support (unspecified),” “goal setting (outcome)” were the main BCTs identified based on barriers and facilitators.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The barriers and facilitators to clinical research participation identified in this study involved three main themes of personal, environmental, and research characteristics, which mainly mapped to five TDF domains. Based on these barriers and facilitators, 23 BCTs were identified. Future research should focus on developing behavior change interventions, assessing their efficacy and implementability.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 4","pages":"782-794"},"PeriodicalIF":3.6,"publicationDate":"2024-12-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142894920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Guidance Documents for Off-Label Drug Use Management for Chinese Health Care Institutions: A Scoping Review","authors":"Changcheng Shi,&nbsp;Yingying Yang,&nbsp;Changling Wu,&nbsp;Limin Wang,&nbsp;Yehua Dong,&nbsp;Yajun Qi,&nbsp;Lingling Hu,&nbsp;Ling Chen,&nbsp;Qingyu Li,&nbsp;Qianqian Jiang,&nbsp;Nengming Lin,&nbsp;Gang Wang","doi":"10.1111/jebm.12669","DOIUrl":"10.1111/jebm.12669","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Off-label drug use (OLDU) is a common practice in health care institutions, and numerous guidance documents have been developed to guide the management of OLDU in China. This scoping review aims to compare these documents and identify existing issues.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>PubMed, EMbase, three Chinese databases, the National Public Service Platform for Standards Information and the official websites of pharmaceutical-related associations were searched to identify guidance documents relevant to the management of OLDU for Chinese health care institutions. We extracted and compared the recommended practices for various aspects of OLDU management, including management systems, organizational structure, prerequisites for OLDU, approval processes, evidence-based evaluation, informed consent, and other related aspects.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 16 guidance documents were included, comprising 12 expert consensuses, 2 practice guidelines, and 2 group standards. Only six documents provide specific requirements for the establishment of management systems. Management of OLDU requires involvement from multiple departments or committees, yet only a few documents explicitly delineate the supervisory authority, and the responsibilities of the parties involved. These documents also show significant disparities in their approval process, evidence-based evaluation, and informed consent recommendations. Furthermore, only a minority of the documents provide specific requirements for training and assessments focused on OLDU and improving adverse reaction monitoring.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>These guidance documents differ significantly in their specific recommendations for the management of OLDU and lack sufficient emphasis on certain critical aspects. It may be beneficial for health administrative authorities to promote the development of unified national guidelines.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 4","pages":"808-821"},"PeriodicalIF":3.6,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142882280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}