Generalizability

泛化
  • 文章类型: Journal Article
    近年来,用于分析文本数据的自然语言处理(NLP)技术取得了快速而巨大的进步。这项研究努力通过检查NLP应用在1990年至2021年的咨询和心理治疗中的使用情况来提供最新的审查。这次范围审查的目的是确定趋势,进步,这些应用的挑战和局限性。在这篇综述中的41篇论文中,确定了4个主要研究目的:(1)开发自动编码;(2)预测结果;(3)监测咨询会议;(4)调查语言模式。我们的研究结果表明,利用先进机器学习方法的论文数量呈上升趋势,特别是神经网络。不幸的是,只有三分之一的文章解决了偏见和普遍性问题。我们的发现提供了及时的系统更新,阐明与偏见有关的担忧,NLP在咨询和心理治疗中应用的普遍性和有效性。
    Recent years have witnessed some rapid and tremendous progress in natural language processing (NLP) techniques that are used to analyse text data. This study endeavours to offer an up-to-date review of NLP applications by examining their use in counselling and psychotherapy from 1990 to 2021. The purpose of this scoping review is to identify trends, advancements, challenges and limitations of these applications. Among the 41 papers included in this review, 4 primary study purposes were identified: (1) developing automated coding; (2) predicting outcomes; (3) monitoring counselling sessions; and (4) investigating language patterns. Our findings showed a growing trend in the number of papers utilizing advanced machine learning methods, particularly neural networks. Unfortunately, only a third of the articles addressed the issues of bias and generalizability. Our findings provided a timely systematic update, shedding light on concerns related to bias, generalizability and validity in the context of NLP applications in counselling and psychotherapy.
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  • 文章类型: Journal Article
    阿尔茨海默病神经影像学倡议(ADNI)旨在改善阿尔茨海默病(AD)的临床试验。自2006年以来,ADNI分享了临床,神经影像学,和认知数据,和生物流体样本。我们使用常规搜索方法,使用ADNI数据/样本识别2021年至2022年的1459篇出版物,并审查了291篇有影响力的研究。这篇综述详细介绍了ADNI研究如何提高对疾病进展的理解和临床试验效率。学科选择的进展,检测治疗效果,协调,和建模改进的临床试验和血浆生物标志物,如磷酸化tau显示出临床使用的希望。淀粉样β的生物标志物,tau,神经变性,炎症,其他人则使用在线可用的个性化预测算法进行预后。研究支持淀粉样蛋白级联反应,强调神经炎症的重要性,以及疾病中详细的广泛异质性,与遗传和血管风险有关,共病,性别,和韧性。一致观察到生物亚型。ADNI结果的普遍性受到缺乏队列多样性的限制,ADNI-4旨在通过招募多样化的队列来解决一个问题。
    The Alzheimer\'s Disease Neuroimaging Initiative (ADNI) aims to improve Alzheimer\'s disease (AD) clinical trials. Since 2006, ADNI has shared clinical, neuroimaging, and cognitive data, and biofluid samples. We used conventional search methods to identify 1459 publications from 2021 to 2022 using ADNI data/samples and reviewed 291 impactful studies. This review details how ADNI studies improved disease progression understanding and clinical trial efficiency. Advances in subject selection, detection of treatment effects, harmonization, and modeling improved clinical trials and plasma biomarkers like phosphorylated tau showed promise for clinical use. Biomarkers of amyloid beta, tau, neurodegeneration, inflammation, and others were prognostic with individualized prediction algorithms available online. Studies supported the amyloid cascade, emphasized the importance of neuroinflammation, and detailed widespread heterogeneity in disease, linked to genetic and vascular risk, co-pathologies, sex, and resilience. Biological subtypes were consistently observed. Generalizability of ADNI results is limited by lack of cohort diversity, an issue ADNI-4 aims to address by enrolling a diverse cohort.
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  • 文章类型: Journal Article
    背景:在随机临床试验(RCT)中具有代表性的人群可以提高试验结果的外部有效性和普遍性。研究RCT登记人群和真实世界人群在血流感染(BSI)方面的差异的数据有限。
    目的:我们进行了范围审查,旨在审查评估BSIRCT人群普遍性的研究,确定系统代表性不足的亚组,并探索提高未来RCT外部有效性的方法。
    方法:MEDLINE,Embase,并在Cochrane图书馆数据库中搜索与外部有效性或泛化性相关的术语,BSI,以及截至2023年8月1日发表的论文中的临床试验。比较入选和非入选患者的研究,或包括在BSIRCT背景下讨论外部有效性或普遍性的论文。
    背景:最终审查中包含了16篇论文。五名比较了来自同一来源人群的RCT注册和非注册参与者。在所有研究中,两组之间存在显着差异。未纳入的患者的合并症负担更大,包括死亡率在内的结局持续更差。我们确定了提高RCT人群普遍性的几个障碍,并概述了减少这些障碍的潜在方法,如替代/简化的同意程序,简化资格标准和后续程序,基于配额的抽样技术,并确保地点和研究团队选择的多样性。
    结论:BSI随机对照试验中的研究队列并不代表一般的BSI患者群体。随着我们越来越多地在传染病领域采用大型务实试验,重要的是要认识到最大限度地推广的重要性,以确保我们的研究结果与我们的患者直接相关.
    BACKGROUND: Having a representative population in randomized clinical trials (RCTs) improves external validity and generalizability of trial results. There are limited data examining differences between RCT-enrolled and real-world populations in bloodstream infections (BSI).
    OBJECTIVE: We conducted a scoping review aiming to review studies assessing generalizability of BSI RCT populations, to identify sub-groups that have been systematically under-represented and to explore approaches to improve external validity of future RCTs.
    METHODS: MEDLINE, Embase, and Cochrane Library databases were searched for terms related to external validity or generalizability, BSI, and clinical trials in papers published up to 1 August 2023. Studies comparing enrolled versus nonenrolled patients, or papers discussing external validity or generalizability in the context of BSI RCTs were included.
    BACKGROUND: Sixteen papers were included in the final review. Five compared RCT-enrolled and nonenrolled participants from the same source population. There were significant differences between the two groups in all studies, with nonenrolled patients having a greater comorbidity burden and consistently worse outcomes including mortality. We identified several barriers to improving generalizability of RCT populations and outlined potential approaches to reduce these barriers, such as alternative/simplified consent processes, streamlining eligibility criteria and follow-up procedures, quota-based sampling techniques, and ensuring diversity in site and study team selection.
    CONCLUSIONS: Study cohorts in BSI RCTs are not representative of the general BSI patient population. As we increasingly adopt large pragmatic trials in infectious diseases, it is important to recognize the importance of maximizing generalizability to ensure that our research findings are of direct relevance to our patients.
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  • 文章类型: Journal Article
    科学界内外的批评声音指出了一个严重的问题,即谁包括在研究中,谁不包括在研究中。随后的调查显示,在进行人类主题研究的广泛学科中,存在广泛的抽样偏见,称为“WEIRD”:西方,受过教育,工业,有钱,和民主。最近的工作表明,这种模式存在于人机交互(HCI)研究中,也是。那么,人机交互(HRI)的表现如何?是否还有其他采样偏差的模式在起作用,也许与该研究领域特别相关的?我们对ACM/IEEE国际人机交互会议(2006-2022)进行了系统的回顾,以发现HRI研究是否以及如何进行WEIRD。重要的是,我们将权限扩大到其他代表性因素,这些因素是关于包容性和交叉性的关键工作所强调的,这些因素可能被低估,被忽视,甚至是人类多样性的边缘化因素。来自749篇论文的827项研究的结果证实,HRI研究的参与者也倾向于来自WEIRD人群。此外,我们发现证据有限,模糊,以及参与者沿着多样性的关键轴心抽样和报告中可能存在的错误陈述:性别和性别,种族和民族,年龄,性和家庭结构,残疾,身体类型,意识形态,和领域专业知识。我们讨论了招聘的方法论和道德含义,分析,和报告,以及HRI作为知识基础的重要性。
    Critical voices within and beyond the scientific community have pointed to a grave matter of concern regarding who is included in research and who is not. Subsequent investigations have revealed an extensive form of sampling bias across a broad range of disciplines that conduct human subjects research called \"WEIRD\": Western, Educated, Industrial, Rich, and Democratic. Recent work has indicated that this pattern exists within human-computer interaction (HCI) research, as well. How then does human-robot interaction (HRI) fare? And could there be other patterns of sampling bias at play, perhaps those especially relevant to this field of study? We conducted a systematic review of the premier ACM/IEEE International Conference on Human-Robot Interaction (2006-2022) to discover whether and how WEIRD HRI research is. Importantly, we expanded our purview to other factors of representation highlighted by critical work on inclusion and intersectionality as potentially underreported, overlooked, and even marginalized factors of human diversity. Findings from 827 studies across 749 papers confirm that participants in HRI research also tend to be drawn from WEIRD populations. Moreover, we find evidence of limited, obscured, and possible misrepresentation in participant sampling and reporting along key axes of diversity: sex and gender, race and ethnicity, age, sexuality and family configuration, disability, body type, ideology, and domain expertise. We discuss methodological and ethical implications for recruitment, analysis, and reporting, as well as the significance for HRI as a base of knowledge.
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  • 文章类型: Meta-Analysis
    背景由于不合理的排除标准,随机临床试验(RCTs)可能无法代表现实人群。我们试图确定哪些患者被排除在包括降脂治疗的RCTs之外。方法和结果我们从胆固醇治疗试验者合作中检索了所有试验,并系统地搜索了大型(≥1000名参与者)降脂治疗RCT,定义为他汀类药物,ezetimibe,和PCSK9抑制剂。我们预定义的群体:老年人(>70或>75岁),女人,非白人,慢性肾衰竭,心力衰竭,免疫抑制,癌症,痴呆症,治疗的甲状腺疾病,慢性阻塞性肺疾病,精神疾病,心房颤动,多发病率(≥2慢性疾病),和多药房。我们计算了排除预定组患者的RCT数量,并对纳入患者的患病率进行了荟萃分析,以获得随机效应模型的汇总估计值。我们纳入了42项RCT(298605例患者)。81%的试验排除了重度肾衰竭患者,76%排除了中度肾衰竭患者。71%的试验排除了女性群体,64%排除了中度至重度心力衰竭患者,64%的人患有免疫抑制剂,48%的人患有癌症,29%的痴呆症患者,29%的试验排除了老年人.>70岁患者的合并患病率为25%(95%CI,0%-49%),11%(3%-18%)>75岁,和51%(38%-63%)的多浊度。结论大多数降脂治疗试验排除了常见疾病患者,如中度至重度肾脏疾病或心力衰竭或免疫抑制。低估了某些人口,包括女性和老年人,可能导致研究结果的可传输性有限,以及这些组中可能的副作用和疗效的不确定性。未来的试验应促进招募策略的多样性,并改善心血管研究的公平性。注册URL:ClinicalTrials.gov;唯一标识符:CRD42021253909。
    Background Randomized clinical trials (RCTs) might not be representative of the real-world population because of unreasonable exclusion criteria. We sought to determine which groups of patients are excluded from RCTs that included lipid-lowering therapy. Methods and Results We retrieved all trials from the Cholesterol Treatment Trialists Collaboration and systematically searched for large (≥1000 participants) lipid-lowering therapy RCTs, defined as statins, ezetimibe, and PCSK9 inhibitors. We predefined groups: older adults (>70 or >75 years), women, non-Whites, chronic kidney failure, heart failure, immunosuppression, cancer, dementia, treated thyroid disease, chronic obstructive pulmonary disease, mental illness, atrial fibrillation, multimorbidity (≥2 chronic diseases), and polypharmacy. We counted the number of RCTs excluding patients of the predefined groups and meta-analyzed the prevalence of included patients to obtain pooled estimates with a random-effects model. We included 42 RCTs (298 605 patients). Eighty-one percent of trials excluded patients with severe and 76% those with moderate kidney failure. Seventy-one percent of trials excluded groups of women, 64% excluded patients with moderate to severe heart failure, 64% those with immunosuppressant conditions, 48% those with cancer, 29% those with dementia, and 29% of trials excluded older adults. The pooled prevalence for patients >70 years of age was 25% (95% CI, 0%-49%), 11% (3%-18%) for >75 years of age, and 51% (38%-63%) for multimorbidity. Conclusions The majority of lipid-lowering therapy trials excluded patients with common diseases, such as moderate-to-severe kidney disease or heart failure or with immunosuppression. Underrepresenting certain populations, including women and older adults, might lead to limited transportability of study results and uncertainty on possible side-effects and efficacy in these groups. Future trials should promote diversity in the recruitment strategies and improve equity in cardiovascular research. Registration URL: ClinicalTrials.gov; Unique Identifier: CRD42021253909.
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  • 文章类型: Journal Article
    如果仅允许不具有代表性的患者子集参加,则临床试验告知慢性疼痛护理的能力可能受到限制。我们总结并报告了有关已发表研究的新见解,这些研究报告了试验排除如何影响其结果的普遍性。我们对以下术语进行了PubMed搜索:(“资格标准”和可概括性)或(“排除标准”和可概括性)或“排除标准”[ti]或“资格标准”[ti])和疼痛。我们仅在分析了以下方面的数据时才考虑相关研究:(1)排除标准的患病率和性质或(2)排除标准对样本代表性或研究结果的影响。确定的4篇文章报告了不同临床试验中纳入和排除的患者的差异:排除的患者年龄较大,不太可能有一份有偿工作,在基线时有更多的功能限制,更经常使用强阿片类药物。这些差异的临床意义尚不清楚。疼痛医学文献很少发表关于排除标准的患病率和影响的研究。而被排除的患者的结局很少被追踪.由于慢性疼痛通常与精神病合并症同时发生,因此频繁使用心理社会排斥尤其会损害普遍性。在研究样本中纳入更具代表性的患者可以减少招募障碍,并扩大慢性疼痛患者发现的普遍性。我们还呼吁进行更多的研究,以检查排除标准在慢性疼痛试验中的使用,以更好地理解其含义。
    The ability of clinical trials to inform the care of chronic pain may be limited if only an unrepresentative subset of patients are allowed to enroll. We summarize and report new insights on published studies that report on how trial exclusions affect the generalizability of their results. We conducted a PubMed search on the following terms: ((\"eligibility criteria\" AND generalizability) OR (\"exclusion criteria\" AND generalizability) OR \"exclusion criteria\"[ti] OR \"eligibility criteria\"[ti]) AND pain. We only considered studies relevant if they analyzed data on (1) the prevalence and nature of exclusion criteria or (2) the impact of exclusion criteria on sample representativeness or study results. The 4 articles that were identified reported differences in patients who were included and excluded in different clinical trials: excluded patients were older, less likely to have a paid job, had more functional limitations at baseline, and used strong opioids more often. The clinical significance of these differences remains unclear. The pain medicine literature has very few published studies on the prevalence and impact of exclusion criteria, and the outcomes of excluded patients are rarely tracked. The frequent use of psychosocial exclusions is especially compromising to generalizability because chronic pain commonly co-occurs with psychiatric comorbidities. Inclusion of more representative patients in research samples can reduce recruitment barriers and broaden the generalizability of findings in patients with chronic pain. We also call for more studies that examine the use of exclusion criteria in chronic pain trials to better understand their implications.
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  • 文章类型: Systematic Review
    我们旨在评估COVID-19相关随机对照试验(RCT)中关键患者级人口统计学和临床特征的报告。
    我们查询了PubMed的英文文章,WebofScience,clinicaltrials.gov,和CDC灰色文献数据库图书馆,使用“冠状病毒”的关键词,\"\"covid,“临床试验”和“随机对照试验”,时间为2020年1月至2021年6月。从搜索中,我们进行了初步审查,以排除重复的条目,确定符合纳入标准的(即,有结果),并排除那些不符合RCT定义的。最后,我们提取了每个RCT报告的人口统计学和临床特征.
    从最初的43627份手稿来看,我们的最终合格手稿包括137篇文章中描述的149份RCT.大多数RCT(113/149)研究了潜在的治疗方法,虽然研究的疫苗较少(29),预防策略(5),以及防止感染者之间传播的干预措施(2)。研究人群从10到38206名参与者(中位数=100,IQR:60-300)。所有149个随机对照试验报告的年龄,147关于性,50场比赛,和110关于至少一种合并症的患病率。没有RCT报告收入,城市与农村住宅,或其他社会经济地位指标(SES)。
    关于种族和其他SES标记的有限报告使得很难得出关于特定外部目标人群的结论,而不做出治疗效果是同质的强有力假设。这些发现突出表明,有必要对参加COVID-19相关随机对照试验的患者的临床和人口统计学特征进行更可靠的报告。
    We aim to assess the reporting of key patient-level demographic and clinical characteristics among COVID-19 related randomized controlled trials (RCTs).
    We queried English-language articles from PubMed, Web of Science, clinicaltrials.gov, and the CDC library of gray literature databases using keywords of \"coronavirus,\" \"covid,\" \"clinical trial\" and \"randomized controlled trial\" from January 2020 to June 2021. From the search, we conducted an initial review to rule-out duplicate entries, identify those that met inclusion criteria (i.e., had results), and exclude those that did not meet the definition of an RCT. Lastly, we abstracted the demographic and clinical characteristics reported on within each RCT.
    From the initial 43 627 manuscripts, our final eligible manuscripts consisted of 149 RCTs described in 137 articles. Most of the RCTs (113/149) studied potential treatments, while fewer studied vaccines (29), prophylaxis strategies (5), and interventions to prevent transmission among those infected (2). Study populations ranged from 10 to 38 206 participants (median = 100, IQR: 60-300). All 149 RCTs reported on age, 147 on sex, 50 on race, and 110 on the prevalence of at least one comorbidity. No RCTs reported on income, urban versus rural residence, or other indicators of socioeconomic status (SES).
    Limited reporting on race and other markers of SES make it difficult to draw conclusions about specific external target populations without making strong assumptions that treatment effects are homogenous. These findings highlight the need for more robust reporting on the clinical and demographic profiles of patients enrolled in COVID-19 related RCTs.
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  • 文章类型: Journal Article
    在严格评估随机对照试验(RCT)进行系统评价时,内部和外部有效性是最相关的组成部分。然而,没有黄金标准来评估外部有效性。这可能与术语的异质性以及可用工具的测量属性的不清楚证据有关。本综述的目的是确定评估RCT外部有效性的工具。它更进一步,评估已确定工具的质量,并建议在未来的系统评价中使用单独的工具来评估RCT的外部有效性。
    在四个数据库中进行了两阶段系统的文献检索:PubMed,Scopus,PsycINFO通过OVID,通过EBSCO和CINAHL。首先,确定了评估RCT外部有效性的工具。第二,选择了研究这些工具的测量特性的研究。使用基于健康测量指标选择标准的COSMIN(COSMIN)指南的修改版本评估了每个包含工具的测量特性。
    38种出版物报告了28种工具的开发或验证。对于61%(17/28)的包含工具,没有测量特性的证据。对于剩余的工具,可靠性是最经常评估的属性。可靠性被认为对三种工具“足够”(证据的确定性非常低)。对于一个工具,内容有效性被评为“足够”(证据的中等确定性)。
    基于这些结果,在系统评价中,没有可用的工具可以完全推荐用于评估RCTs的外部有效性.需要几个步骤来克服所确定的困难,以适应和验证可用工具或开发更好的合适工具。
    开放科学框架(OSF)的预期注册:https://doi.org/10.17605/OSF。IO/PTG4D。
    Internal and external validity are the most relevant components when critically appraising randomized controlled trials (RCTs) for systematic reviews. However, there is no gold standard to assess external validity. This might be related to the heterogeneity of the terminology as well as to unclear evidence of the measurement properties of available tools. The aim of this review was to identify tools to assess the external validity of RCTs. It was further, to evaluate the quality of identified tools and to recommend the use of individual tools to assess the external validity of RCTs in future systematic reviews.
    A two-phase systematic literature search was performed in four databases: PubMed, Scopus, PsycINFO via OVID, and CINAHL via EBSCO. First, tools to assess the external validity of RCTs were identified. Second, studies investigating the measurement properties of these tools were selected. The measurement properties of each included tool were appraised using an adapted version of the COnsensus based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.
    38 publications reporting on the development or validation of 28 included tools were included. For 61% (17/28) of the included tools, there was no evidence for measurement properties. For the remaining tools, reliability was the most frequently assessed property. Reliability was judged as \"sufficient\" for three tools (very low certainty of evidence). Content validity was rated as \"sufficient\" for one tool (moderate certainty of evidence).
    Based on these results, no available tool can be fully recommended to assess the external validity of RCTs in systematic reviews. Several steps are required to overcome the identified difficulties to either adapt and validate available tools or to develop a better suitable tool.
    Prospective registration at Open Science Framework (OSF): https://doi.org/10.17605/OSF.IO/PTG4D .
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  • 文章类型: Journal Article
    目的:关于经导管主动脉瓣植入术(TAVI)的经济承受能力的科学文献辩论,以便为旨在建立TAVI报销计划的决策者提供有用的支持。出于这个原因,重要的是评估现有经济证据的质量和普遍性。
    方法:第一步是根据预定义的人群进行文献检索,干预,比较器,与药物治疗和传统手术相比,TAVI手术的成本和有效性。第二,在主要HTA机构的网站上进行了手动搜索。第三,Augustovski等人开发的清单。是为了评估选择过程中产生的文章的质量和通用性。
    结果:总体而言,共获得106篇文章。其中,由于标题与目标不一致,因此排除了65条。经过摘要和全文阅读后,进行了进一步的选择。最后,审查包括31份文件。根据检查表,没有一篇文章被认为是可推广的,只有一篇文章被认为是可转移的,这将TAVI手术与无法手术的患者的医疗管理进行了比较.
    结论:尽管所选研究的总体质量被认为是良好的,对于在不同背景下产生的证据是否可以被认为是可概括的,仍然缺乏证据。需要对资源消耗和偏好进行进一步研究,以便为决策者提供更有力的证据。
    OBJECTIVE: Scientific literature debates on the economic affordability of transcatheter aortic valve implantation (TAVI) in order to give a useful support to decision makers aiming at establishing a reimbursement scheme for TAVI. For this reason, it is important to assess the quality and the generalizability of the existing economic evidences.
    METHODS: The first step was to run a literature search according to a predefined population, intervention, comparator, and outcome on the cost and effectiveness of the TAVI procedure in comparison to medical therapy and traditional surgery. Second, a manual search was carried out on the Web sites of the main HTA agencies. Third, the checklist developed by Augustovski et al. was applied in order to assess the quality and the generalizability of the articles resulting from the selection process.
    RESULTS: Overall, 106 articles were obtained. Of these, sixty-five articles were excluded since the title was not consistent with the objective. Further selection took place after abstract and full-text reading. In the end, thirty-one documents were included for the review. According to the checklist, none of the articles was considered generalizable and only one was considered transferable which compares the TAVI procedure with Medical Management in inoperable patients.
    CONCLUSIONS: Despite the overall quality of the selected studies was considered good, there is still a lack of evidence on whether evidences generated in different contexts can be considered generalizable. Further research on resource consumption and preferences is needed in order to provide decision makers with more robust evidences.
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  • 文章类型: Journal Article
    艾滋病毒在不同的人群中都有经历,性别和种族/族裔少数群体患有相当大比例的疾病。随着美国国立卫生研究院(NIH)将妇女和种族/族裔少数群体的入学列为优先事项,了解研究参与者的多样性很重要。我们试图描述艾滋病毒治愈研究如何报告多样性数据。审查了由MartinDelaneyCollaborators于2019年为HIV研究提供资金的出版物抽样框架,以报告人口统计数据。在55份出版物中,包括对人类/人类标本的研究,只有51%的人提供了任何人口统计学描述。在艾滋病毒治疗研究中,通常对人群多样性的考虑不足。缩小这方面的差距将需要招募不同的人群/标本和规格,以报告文章中的人口统计数据。这将确保从最早的实验室到最终的III期研究,将不同的参与者纳入HIV治愈研究。
    HIV is experienced across diverse populations, with gender and racial/ethnic minority populations bearing a significant proportion of disease. With National Institutes of Health (NIH) placing a priority on the enrollment of women and racial/ethnic minorities into studies, it is important to understand the diversity of participants in research. We sought to characterize how HIV cure research studies report data on diversity. A sampling frame of publications with funding provided by the Martin Delaney Collaboratories for HIV Research in 2019 was reviewed for reporting of demographic data. Of 55 publications that included research on humans/human specimens, only 51% provided any demographic description. There often is insufficient consideration of diversity of populations in HIV cure research. Ameliorating gaps in this regard will require recruitment of diverse populations/specimens and specifications to report demographic data in articles. This will ensure inclusion of diverse participants in HIV cure research from earliest laboratory to eventual phase III studies.
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