Reporting

报告
  • 文章类型: Journal Article
    这项荟萃研究旨在评估脊柱疼痛或骨关节炎(OA)患者预测模型研究报告的完整性,以遵守多变量预测模型的透明报告个体预后或诊断(TRIPOD)声明。我们在MEDLINE中寻找脊柱疼痛或OA患者的预后和诊断预测模型,Embase,WebofScience,和CINAHL。使用标准化的评估表格,我们评估了纳入研究对TRIPOD的依从性.两名独立的审阅者进行了研究选择和数据提取阶段。我们纳入了66项研究。大约35%的研究宣布使用了TRIPOD。总体上对TRIPOD的依从性中位数为59%(IQR:21.8),方法和结果部分的项目报告最差。对颈部疼痛的研究比对背痛和OA的研究具有更好的依从性(中位数为76.5%,59%,53%,分别)。在所有研究类型中,外部验证研究的总依从性最高(中位数:79.5%;IQR:12.8)。在宣布使用TRIPOD的研究中,中位总体依从性比不使用TRIPOD的研究高4分。最后,多年来,我们没有观察到依从性有任何改善.脊柱和OA领域对预测模型TRIPOD的依从性较低,方法和结果部分的报道最差。关于脊柱疼痛和OA预测模型的未来研究应遵循TRIPOD,以提高其报告的完整性。前景:本文提供了66项脊柱疼痛或骨关节炎预测模型研究中对TRIPOD声明的依从性数据。发现对TRIPOD声明的依从性普遍较低(依从性中位数为59%)。这种不充分的报告可能会对模型在临床实践中的有效使用产生负面影响。
    This meta-research study aimed to evaluate the completeness of reporting of prediction model studies in patients with spinal pain or osteoarthritis (OA) in terms of adherence to the Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD) statement. We searched for prognostic and diagnostic prediction models in patients with spinal pain or OA in MEDLINE, Embase, Web of Science, and CINAHL. Using a standardized assessment form, we assessed the adherence to the TRIPOD of the included studies. Two independent reviewers performed the study selection and data extraction phases. We included 66 studies. Approximately 35% of the studies declared to have used the TRIPOD. The median adherence to the TRIPOD was 59% overall (IQR: 21.8), with the items of the methods and results sections having the worst reporting. Studies on neck pain had better adherence to the TRIPOD than studies on back pain and OA (medians of 76.5%, 59%, and 53%, respectively). External validation studies had the highest total adherence (median: 79.5%; IQR: 12.8) of all the study types. The median overall adherence was 4 points higher in studies that declared TRIPOD use than those that did not. Finally, we did not observe any improvement in adherence over the years. The adherence to the TRIPOD of prediction models in the spinal and OA fields is low, with the methods and results sections being the most poorly reported. Future studies on prediction models in spinal pain and OA should follow the TRIPOD to improve their reporting completeness. PERSPECTIVE: This article provides data about adherence to the TRIPOD statement in 66 prediction model studies for spinal pain or osteoarthritis. The adherence to the TRIPOD statement was found to be generally low (median adherence of 59%). This inadequate reporting may negatively impact the effective use of the models in clinical practice.
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  • 文章类型: Journal Article
    背景/目的:炎症性肠病(IBDs)是一种慢性疾病,需要使用磁共振小肠造影(MRE)等成像技术进行密切监测。放射学报告的标准化对于IBD的最佳管理至关重要。我们调查了意大利放射科医生的MRE检查和IBD报告经验。方法:2023年4月,邀请意大利医学和介入放射学学会(SIRM)的所有成员完成匿名问卷。根据最小频率组使用χ2检验或Fisher精确检验评估变量之间的比较检验。显著性水平设定为p值<0.05。结果:共有253名放射科医生对调查做出了回应。大约70%的受访者表示有IBD的个人临床经验。与包括和描述的两种疾病活动的项目非常一致(即,肠壁厚度,粘膜溃疡的存在,水肿的存在,粘液增强)和并发症。三分之一的受访者经常使用结构化的MRE报告。每年有大量IBD患者(>1000)的中心主要使用3T扫描仪或同时使用1.5T和3T扫描仪(p<0.001)。疾病活动评分的纳入与大学和高容量医院相关(p<0.001)。结论:这项调查强调了意大利放射科医生中IBD患者MRE报告的当前常规做法和经验。我们发现在MRE报告中使用放射学评分和参加IBD多学科会议方面存在缺陷。
    Background/Objectives: Inflammatory bowel diseases (IBDs) are chronic disorders that require close monitoring with imaging techniques such as magnetic resonance enterography (MRE). Standardization of radiological reports is crucial for the optimal management of IBD. We surveyed Italian radiologists regarding their experiences with MRE examinations and reporting for IBD. Methods: All members of the Italian Society of Medical and Interventional Radiology (SIRM) were invited to complete an anonymous questionnaire in April 2023. Comparison tests between variables were assessed using the χ2 test or Fisher exact test according to the least frequency group. Significance level was set for p-value < 0.05. Results: A total of 253 radiologists responded to the survey. Around 70% of the respondents declared personal clinical experience with IBD. Great agreement with the items included and described for both disease activity (i.e., intestinal wall thickness, presence of mucosal ulcers, presence of edema, mucous enhancement) and complications was reported. One-third of the respondents regularly used a structured MRE report. Centers with a high number of IBD patients per year (>1000) mostly used 3 T scanners or both 1.5 T and 3 T scanners (p < 0.001). The incorporation of scores of disease activity was associated with university and high-volume hospitals (p < 0.001). Conclusions: This survey highlighted the current routine practice and experience of MRE reports of IBD patients among Italian radiologists. We found deficiencies in the use of radiological scores in MRE reports and attendance at IBD multidisciplinary meetings.
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  • 文章类型: Journal Article
    背景:自杀是全球死亡的主要原因。新闻报道准则旨在遏制不安全报道的影响;然而,在新闻报道中自杀的框架可能因情况和死者的性别等重要特征而有所不同。
    目的:本研究旨在研究新闻媒体对自杀报道使用污名化或荣耀化的语言进行陷害的程度,以及性别和自杀情况在这种陷害方面的差异。
    方法:我们分析了200篇有关自杀的新闻文章,并应用经过验证的自杀污名量表来识别污名化和荣耀化的语言。我们用2个广泛使用的指标来评估语言相似性,余弦相似性和互信息得分,使用基于机器学习的大型语言模型。
    结果:男性自杀的新闻报道比女性自杀的报道更类似于污名化(P<.001)和美化(P=.005)语言。考虑到自杀的情况,互信息得分表明,在使用污名化或美化语言的性别差异最明显的文章归因于法律(0.155),关系(0.268),或心理健康问题(0.251)为原因。
    结论:语言差异,按性别,在报告自杀时使用污名化或美化语言可能会加剧自杀差异。
    BACKGROUND: Suicide is a leading cause of death worldwide. Journalistic reporting guidelines were created to curb the impact of unsafe reporting; however, how suicide is framed in news reports may differ by important characteristics such as the circumstances and the decedent\'s gender.
    OBJECTIVE: This study aimed to examine the degree to which news media reports of suicides are framed using stigmatized or glorified language and differences in such framing by gender and circumstance of suicide.
    METHODS: We analyzed 200 news articles regarding suicides and applied the validated Stigma of Suicide Scale to identify stigmatized and glorified language. We assessed linguistic similarity with 2 widely used metrics, cosine similarity and mutual information scores, using a machine learning-based large language model.
    RESULTS: News reports of male suicides were framed more similarly to stigmatizing (P<.001) and glorifying (P=.005) language than reports of female suicides. Considering the circumstances of suicide, mutual information scores indicated that differences in the use of stigmatizing or glorifying language by gender were most pronounced for articles attributing legal (0.155), relationship (0.268), or mental health problems (0.251) as the cause.
    CONCLUSIONS: Linguistic differences, by gender, in stigmatizing or glorifying language when reporting suicide may exacerbate suicide disparities.
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  • 文章类型: Journal Article
    评估在伊朗进行的2型糖尿病随机对照试验的方法学质量,并在临床实践指南以及系统评价和荟萃分析中引用。
    我们进行了描述性方法学质量审查,分析2004年7月至2021年在伊朗发表的286项糖尿病随机对照试验(RCT)。我们系统地搜索了六个数据库,并使用CONSORT2010摘要清单评估了符合条件的文章。两名调查人员使用来自CONSORT的17项清单评估了数据。此外,我们检查了260个临床实践指南中每个RCT的引用,特别注重充分报告成果。
    在6667篇文章中,286分析报告不佳,未达到观察到的标准。指南中引用的仅为3.8%。报告率:主要结果(41.9%),随机化(61.8%),试验招募(12.6%),致盲(50.8%)。27.9%在系统评价中被引用,50.34%的系统评价和荟萃分析,元分析中26.57%。67.8%的论文在系统评价中被引用。参与者的依从性最高,目标,随机化,干预,结果;招聘最低,试验设计,资金来源,危害,并报告主要结果。
    在评估的RCT中,方法报告和对CONSORT检查表的依从性差,尤其是在方法论部分。准则中可靠和适用的结果所需的改进,reviews,和荟萃分析。不充分的结果报告挑战研究人员,临床医生,和政策制定者,影响循证决策。迫切需要改进RCT注册。
    UNASSIGNED: Evaluate methodological quality of type 2 diabetes RCTs conducted in Iran and cited in clinical practice guidelines and systematic reviews and meta-analyses.
    UNASSIGNED: We conducted a descriptive methodological quality review, analyzing 286 Randomized Controlled Trials (RCTs) on diabetes mellitus published in Iran from July 2004 to 2021. We searched six databases systematically and evaluated eligible articles using the CONSORT 2010 checklist for abstracts. Two investigators assessed the data using a 17-item checklist derived from CONSORT. Additionally, we examined the citations of each RCT in 260 clinical practice guidelines, with a specific focus on the adequate reporting of outcomes.
    UNASSIGNED: Out of 6667 articles, 286 analyzed. Poor reporting and failure to meet criteria observed. Only 3.8% cited in guidelines. Reporting rates: primary outcomes (41.9%), randomization (61.8%), trial recruitment (12.6%), blinding (50.8%). 27.9% cited in systematic reviews, 50.34% in systematic reviews and meta-analyses, 26.57% in meta-analyses. 67.8% of papers cited in systematic reviews. Adherence highest for participants, objective, randomization, intervention, outcome; lowest for recruitment, trial design, funding source, harms, and reporting primary outcomes.
    UNASSIGNED: Poor methodological reporting and adherence to CONSORT checklist in evaluated RCTs, especially in methodological sections. Improvements needed for reliable and applicable results in guidelines, reviews, and meta-analyses. Inadequate outcome reporting challenges researchers, clinicians, and policymakers, impacting evidence-based decision-making. Urgent improvements in RCT registration necessary.
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  • 文章类型: Journal Article
    化脓性汗腺炎(HS)是一种复杂的炎症性皮肤病,影响0.1-4%的人群,导致腋下永久性瘢痕形成,乳腺下区域,腹股沟,还有臀部.其复杂的发病机制涉及遗传学,先天和适应性免疫,微生物群,和环境刺激。特定人群有较高的HS发病率,包括女性和黑人以及有相关合并症的人。在临床试验和结果研究的背景下,HS注册中心和生物库已经为临床数据的文档制定了标准,但是收藏,文档,在HS实验室研究中,这些重要的临床和人口统计学变量的报告并不常见。需要在实验室环境中进行标准化,因为它有助于阐明机械上导致HS症状和病理生理学的因素。本文的目的是开始为实验室环境中的标准化报告奠定基础。我们讨论了临床指南如何为实验室研究提供信息,我们强调了在湿实验室中使用样品和解释相关机械数据所需的额外信息。通过标准化的数据收集和报告,研究之间的数据协调将改变我们对HS的理解,并导致新的发现,这将对患者护理产生积极影响。
    Hidradenitis suppurativa (HS) is a complex inflammatory skin condition affecting 0.1-4% of the population that leads to permanent scarring in the axilla, inframammary region, groin, and buttocks. Its complex pathogenesis involves genetics, innate and adaptive immunity, microbiota, and environmental stimuli. Specific populations have a higher incidence of HS, including females and Black individuals and those with associated comorbidities. HS registries and biobanks have set standards for the documentation of clinical data in the context of clinical trials and outcomes research, but collection, documentation, and reporting of these important clinical and demographic variables are uncommon in HS laboratory research studies. Standardization in the laboratory setting is needed because it helps to elucidate the factors that contribute mechanistically to HS symptoms and pathophysiology. The purpose of this article is to begin to set the stage for standardized reporting in the laboratory setting. We discuss how clinical guidelines can inform laboratory research studies, and we highlight what additional information is necessary for the use of samples in the wet laboratory and interpretation of associated mechanistic data. Through standardized data collection and reporting, data harmonization between research studies will transform our understanding of HS and lead to novel discoveries that will positively impact patient care.
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  • 文章类型: Journal Article
    背景:在随机对照试验(RCT)中保留参与者具有挑战性,通常需要试验团队使用策略来确保保留或改善保留。除货币激励外,没有要求向参与者披露保留策略的使用情况。此外,并非所有保留策略都是在计划阶段制定的,即协议制定期间的后资助,但一些方案包括参与者保留策略,因为在试验计划阶段早期考虑并计划保留.尚不清楚这些计划是否在相应的参与者信息传单(PIL)中传达。我们研究的目的是确定PIL是否传达促进参与者保留的计划,如果是,这些都在相应的试验方案中概述。
    方法:分析了来自英国临床试验单位(CTU)的92例成人PIL及其90种相应的方案。使用定向(演绎)内容分析来分析来自PIL的参与者保留文本。在适当的情况下,使用叙述性摘要和频率来呈现数据。
    结果:促进参与者保留的计划在81.5%(n=75/92)的PIL中进行了沟通。57%(n=43/75)的PIL传达了使用“组合策略”来促进参与者保留的计划。最常见的个人保留策略是告诉参与者,试验的数据收集将安排在常规护理访视期间(16%;n=12/75PIL)。保留的重要性以及缺失或删除数据(删除前收集的数据)对回答研究问题的能力的影响分别在6.5%(n=6/92)和5.4%(n=5/92)的PIL中进行了解释。在59个PIL和58个匹配协议中,这两个协议都传达了使用策略来促进参与者保留的计划,18.6%(n=11/59)传达了相同的信息,其余81.4%(n=48/59)的PIL仅部分传达(45.8%;n=27/59)相同的信息,或未与方案传达相同的信息(35.6%;n=21/59)。
    结论:保留策略经常传达给PILs的潜在试验参与者;然而,提供的信息通常与相应协议中的内容不同。参与者的保留考虑最好在试验的计划阶段完成,我们鼓励试验团队在方案和PIL中这些策略的沟通保持一致。
    BACKGROUND: Retaining participants in randomised controlled trials (RCTs) is challenging and trial teams are often required to use strategies to ensure retention or improve it. Other than monetary incentives, there is no requirement to disclose the use of retention strategies to the participant. Additionally, not all retention strategies are developed at the planning stage, i.e. post-funding during protocol development, but some protocols include strategies for participant retention as retention is considered and planned for early in the trial planning stage. It is yet unknown if these plans are communicated in the corresponding participant information leaflets (PILs). The purpose of our study was to determine if PILs communicate plans to promote participant retention and, if so, are these outlined in the corresponding trial protocol.
    METHODS: Ninety-two adult PILs and their 90 corresponding protocols from Clinical Trial Units (CTUs) in the UK were analysed. Directed (deductive) content analysis was used to analyse the participant retention text from the PILs. Data were presented using a narrative summary and frequencies where appropriate.
    RESULTS: Plans to promote participant retention were communicated in 81.5% (n = 75/92) of PILs. Fifty-seven percent (n = 43/75) of PILs communicated plans to use \"combined strategies\" to promote participant retention. The most common individual retention strategy was telling the participants that data collection for the trial would be scheduled during routine care visits (16%; n = 12/75 PILs). The importance of retention and the impact that missing or deleted data (deleting data collected prior to withdrawal) has on the ability to answer the research question were explained in 6.5% (n = 6/92) and 5.4% (n = 5/92) of PILs respectively. Out of the 59 PILs and 58 matching protocols that both communicated plans to use strategies to promote participant retention, 18.6% (n = 11/59) communicated the same information, the remaining 81.4% (n = 48/59) of PILs either only partially communicated (45.8%; n = 27/59) the same information or did not communicate the same information (35.6%; n = 21/59) as the protocol with regard to the retention strategy(ies).
    CONCLUSIONS: Retention strategies are frequently communicated to potential trial participants in PILs; however, the information provided often differs from the content in the corresponding protocol. Participant retention considerations are best done at the planning stage of the trial and we encourage trial teams to be consistent in the communication of these strategies in both the protocol and PIL.
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  • 文章类型: Journal Article
    由于肿瘤学的临床试验需要大量的努力,经常尝试通过进行子群分析来最大化从他们那里获得的见解。这些分析的目标是确定可能受益的患者亚组,以及不太可能从研究干预中受益的患者亚组。国际指南偶尔包括或排除基于关键试验的此类分析的针对特定亚群的新药物和技术,而无需进行确认试验。本观点讨论了在报告亚组分析时提供完整的临床信息数据集的重要性,并解释了为什么这种透明度对于更好地对结果进行临床解释以及在临床护理中的适当应用至关重要。通过提供临床研究透明报告的示例和临床研究不完整报告的示例。
    As clinical trials in oncology require substantial efforts, maximizing the insights gained from them by conducting subgroup analyses is often attempted. The goal of these analyses is to identify subgroups of patients who are likely to benefit, as well as the subgroups of patients who are unlikely to benefit from the studied intervention. International guidelines occasionally include or exclude novel medications and technologies for specific subpopulations based on such analyses of pivotal trials without requiring confirmatory trials. This Perspective discusses the importance of providing a complete dataset of clinical information when reporting subgroup analyses and explains why such transparency is key for better clinical interpretation of the results and the appropriate application to clinical care, by providing examples of transparent reporting of clinical studies and examples of incomplete reporting of clinical studies.
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  • 文章类型: Journal Article
    肿瘤突变负荷(TMB)已被认为是几种肿瘤类型中免疫疗法反应的预测性生物标志物。几个实验室提供TMB测试,但是TMB的计算方式存在很大差异,报告,并在实验室中解释。TMB标准化工作正在进行中,但目前尚无已发布的TMB验证和报告指南。认识到临床TMB测试的当前挑战,分子病理学协会召集了一个多学科合作工作组,由美国临床肿瘤学会代表,美国病理学家学院,和癌症免疫治疗协会审查围绕TMB的实验室实践,并根据调查数据为TMB测试的分析验证和报告制定建议,文献综述,专家共识。这些建议包括预分析,分析,以及TMB分析的分析后因素,并强调全面的方法学描述的相关性,以允许测定之间的可比性。
    Tumor mutational burden (TMB) has been recognized as a predictive biomarker for immunotherapy response in several tumor types. Several laboratories offer TMB testing, but there is significant variation in how TMB is calculated, reported, and interpreted among laboratories. TMB standardization efforts are underway, but no published guidance for TMB validation and reporting is currently available. Recognizing the current challenges of clinical TMB testing, the Association for Molecular Pathology convened a multidisciplinary collaborative working group with representation from the American Society of Clinical Oncology, the College of American Pathologists, and the Society for the Immunotherapy of Cancer to review the laboratory practices surrounding TMB and develop recommendations for the analytical validation and reporting of TMB testing based on survey data, literature review, and expert consensus. These recommendations encompass pre-analytical, analytical, and postanalytical factors of TMB analysis, and they emphasize the relevance of comprehensive methodological descriptions to allow comparability between assays.
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  • 文章类型: Journal Article
    本文件旨在为儿科超声心动图的基本和高级报告提供指导。此外,它的目的是帮助临床医生解释超声心动图测量和功能数据,以估计不同年龄段儿童疾病的严重程度。以下主题将在本文件中进行审查和讨论:i)构建儿科超声心动图报告的一般原则,ii)要包括的基本要素,iii)儿科报告期间用于疾病严重程度量化的当前使用的工具的潜力和局限性。将提供Z分数解释指南。将讨论用于量化心室收缩功能的参数的使用和解释。采用成人参数研究不同年龄的舒张功能和瓣膜缺损的困难,将概述压力和负载条件,列出了评估的陷阱。将提供仔细使用复杂先天性心脏病预测评分的指南。将提供儿科超声心动图报告的基本和高级(疾病特异性)格式的示例。本文件应作为全面的指南,以i)构建全面的儿科超声心动图报告,ii)识别基本的形态学细节,措施,和超声心动图报告期间要包括的功能参数,和iii)正确解释用于估计疾病严重程度的测量和功能数据。
    This document has been developed to provide a guide for basic and advanced reporting in pediatric echocardiography. Furthermore, it aims to help clinicians in the interpretation of echocardiographic measurements and functional data for estimating the severity of disease in different pediatric age groups. The following topics will be reviewed and discussed in the present document: i) the general principle in constructing a pediatric echocardiography report, ii) the basic elements to be included, iii) the potential and limitation of currently employed tools used for disease severity quantification during paediatric reporting. A guide for the interpretation of Z-scores will be provided. Use and interpretation of parameters employed for quantification of ventricular systolic function will be discussed. Difficulties in the adoption of adult parameters for the study of diastolic function and valve defects at different ages, pressure and loading conditions will be outlined, with pitfalls for the assessment listed. A guide for careful use of prediction scores for complex congenital heart disease will be provided. Examples of basic and advanced (disease specific) formats for reporting in paediatric echocardiography will be provided. This document should serve as a comprehensive guide to i) structure a comprehensive paediatric echocardiographic report, ii) identify the basic morphological details, measures, and functional parameters to be included during echocardiographic reporting, and iii) correctly interpret measurements and functional data for estimating disease severity.
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  • 文章类型: Journal Article
    背景:虽然PRISMA2020声明旨在指导原始系统评价的报告,更新的系统评价,和实时系统评价(LSR),其解释和阐述文件指出,可能需要解决更新的系统审查和LSR的其他考虑因素。本文报告了为LSR开发PRISMA2020声明扩展的协议。方法:我们将遵循EQUATOR网络的指导制定健康研究报告指南。我们将回顾文献,以确定PRISMA2020清单中需要修改的可能项目,以及需要添加的新项目。然后,我们将调查不同利益相关方团体的代表,了解他们对PRISMA2020清单拟议修改的意见。我们将总结,present,并在网上会议上讨论调查结果,旨在就LSR扩展的内容达成共识。然后我们将起草清单,每个项目的解释和阐述,和PRISMA2020扩展的流程图。然后,我们将与利益相关者代表分享这些初始文件,以获得最终反馈和批准。讨论:我们预计针对LSR的PRISMA2020扩展将使LSR作者受益,编辑,和LSR的同行评审员,以及LSR的不同用户,包括指南开发人员,政策制定者,医疗保健提供者,病人,和其他利益相关者。
    Background: While the PRISMA 2020 statement is intended to guide the reporting of original systematic reviews, updated systematic reviews, and living systematic reviews (LSRs), its explanation and elaboration document notes that additional considerations for updated systematic reviews and LSRs may need to be addressed. This paper reports the protocol for developing an extension of the PRISMA 2020 statement for LSRs. Methods: We will follow the EQUATOR Network\'s guidance for developing health research reporting guidelines. We will review the literature to identify possible items of the PRISMA 2020 checklist that need modification, as well as new items that need to be added. Then, we will survey representatives of different stakeholder groups for their views on the proposed modifications of the PRISMA 2020 checklist. We will summarize, present, and discuss the results of the survey in an online meeting, aiming to reach consensus on the content of the LSR extension. We will then draft the checklist, explanation and elaboration for each item, and flow diagram for the PRISMA 2020 extension. Then, we will share these initial documents with stakeholder representatives for final feedback and approval. Discussion: We anticipate that the PRISMA 2020 extension for LSRs will benefit LSR authors, editors, and peer reviewers of LSRs, as well as different users of LSRs, including guideline developers, policy makers, healthcare providers, patients, and other stakeholders.
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