Reporting

报告
  • 文章类型: Editorial
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  • 文章类型: Journal Article
    统计回归模型用于根据某些预测变量的值预测结果,或用于描述结果与预测因子的关联。手头有一组数据,回归模型可以很容易地适合标准软件包。这带来了数据分析师可能在没有足够基本属性知识的情况下急于执行复杂的分析的风险,他们数据的关联和错误,导致对建模结果的错误解释和表示缺乏清晰度。对数据的特殊特征(诸如冗余或特定分布)的忽视甚至可能使所选择的分析策略无效。初始数据分析(IDA)是回归分析的先决条件,因为它提供了有关确认所选模型构建策略的适当性或完善所需数据的知识。为了正确解释建模结果,并指导建模结果的呈现。为了便于再现,国际开发协会需要预先计划,IDA计划应包括在研究项目的一般统计分析计划中,结果应该有据可查。如果IDA放弃评估结果和预测因素的关联,则最终回归模型的有偏见的统计推断可以最小化。IDA的关键原则。我们就在回归建模的背景下进行数据筛选的IDA计划中考虑哪些方面提供建议,以补充统计分析计划。我们在典型的诊断建模项目的示例中说明了此IDA数据筛选计划,并给出了数据可视化的建议。
    Statistical regression models are used for predicting outcomes based on the values of some predictor variables or for describing the association of an outcome with predictors. With a data set at hand, a regression model can be easily fit with standard software packages. This bears the risk that data analysts may rush to perform sophisticated analyses without sufficient knowledge of basic properties, associations in and errors of their data, leading to wrong interpretation and presentation of the modeling results that lacks clarity. Ignorance about special features of the data such as redundancies or particular distributions may even invalidate the chosen analysis strategy. Initial data analysis (IDA) is prerequisite to regression analyses as it provides knowledge about the data needed to confirm the appropriateness of or to refine a chosen model building strategy, to interpret the modeling results correctly, and to guide the presentation of modeling results. In order to facilitate reproducibility, IDA needs to be preplanned, an IDA plan should be included in the general statistical analysis plan of a research project, and results should be well documented. Biased statistical inference of the final regression model can be minimized if IDA abstains from evaluating associations of outcome and predictors, a key principle of IDA. We give advice on which aspects to consider in an IDA plan for data screening in the context of regression modeling to supplement the statistical analysis plan. We illustrate this IDA plan for data screening in an example of a typical diagnostic modeling project and give recommendations for data visualizations.
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  • 文章类型: Journal Article
    背景和目的虽然心理健康一直是人们关注的主要问题,特别是对于航空公司的飞行员,对于航空业的安全操作,并不总是强调对心理健康的知识和态度。害怕自我报告,柱头,缺乏有关心理健康状况的知识在这个行业很普遍。我们研究的目的是检查飞行员对心理健康问题的看法,他们可用的资源,以及他们可能或可能不报告这些问题的原因。方法我们进行了定性、现象学研究,采访了21名商业飞行员,以更好地了解他们对心理健康问题的看法,可用的自助资源,以及未能报告心理健康问题的理由。结果我们使用NVivo软件的分析结果表明,飞行员既没有报告问题,也没有信任旨在解决心理健康问题的过程。研究中出现了三个主题:(1)飞行员避免讨论心理健康问题,以免受到影响,(2)虽然资源存在,飞行员通常不信任报告系统的机密性,和(3)飞行员诚实地认为,报告任何心理健康问题将是毁灭性的,他们的职业生涯。结论航空公司和联邦航空管理局(FAA)需要改变流程,并在飞行员之间灌输对报告系统的信任感,以便他们感到安全地报告心理健康问题并获得更好的治疗。这可以导致更准确的条件报告并确保安全飞行操作。
    Background and objective Although mental health is always a major concern, particularly for airline pilots, knowledge of and attitudes toward mental health have not always been emphasized for safe operations in the aviation industry. Fear of self-reporting, stigmas, and lack of knowledge about mental health conditions are prevalent in this industry. The purpose of our research was to examine pilots\' perceptions of mental health issues, the resources available to them, and the reasons they may or may not report these issues. Methods We conducted a qualitative, phenomenological study in which 21 commercial pilots were interviewed to better understand their perceptions of mental health issues, available self-help resources, and rationale for failing to report mental health issues. Results The results of our analysis using NVivo software showed that pilots neither reported the issues nor trusted the processes meant to address mental health issues. Three themes emerged from the research: (1) pilots avoid discussing mental health issues for fear of repercussions, (2) although resources exist, pilots generally distrust the confidentiality of reporting systems, and (3) pilots honestly believe that reporting any mental health issue will be devastating to their careers. Conclusions Airline companies and the Federal Aviation Administration (FAA) need to change processes and instill a sense of trust in reporting systems among pilots so that they feel safe reporting mental health concerns and receive improved treatment. This can lead to more accurate reporting of conditions and ensure safe flight operations.
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  • 文章类型: Journal Article
    背景:医疗不良事件(HAE)报告框架不仅仅是一个工具。它是我们追求患者安全的重要支柱,质量改进,信任维护,法规遵从性,和医疗服务的道德标准。
    目的:通过开展满意度调查,评估农村公立医院急诊科医护人员对HAE报告框架和此类报告管理方法的满意度。
    方法:这项前瞻性观察性研究是在北方邦医科大学急诊医学系进行的,赛法伊,和毗邻的地区医院,从2023年11月到2024年1月。该研究涉及320名在急诊科工作的医疗保健专业人员。定量调查研究使用了问卷和Likert质量量表。使用非参数统计方法在序数测量量表上分析数据。使用频率表分析样本数据,百分比饼图,和比较条形图。在非参数统计检验中,单样本Wilcoxon符号秩检验用于推断人口的集中趋势,Kruskal-Wallis检验被用来推断人口类别。
    结果:医疗保健专业人员对HAE报告框架和管理方法的满意度是多种多样的。在对急诊科的HAE报告框架进行调查时,在320名医疗保健专业人员中,50%(161)表示不满,47%(149)满意,3%(10)没有发表评论。护理人员最不满意(133人中的61%)。当被问及处理此类报告时的管理方法时,50%(159)满意,46%(147)不满意,4%(14)没有发表评论。在比较职业时,33名医生中有43%(29)和133名护理人员中有62%(83)不满意,给出一个糟糕的反应。此外,119名护理人员中61%(72)满意。非参数推理测试得出的两个问题的p值都小于0.001,表明人群对HAE报告框架和管理方法的反应存在显著差异。在成对比较中,职业组之间的感知存在显着差异(p<0.001),除了HAE报告框架中的医生和护理人员(p=0.638)。
    结论:通过鼓励报告,标准化流程,彻底分析事件,并使用数据驱动的见解来为改进工作提供信息,医疗保健组织可以提高患者安全,提高护理质量,预防未来的不良事件。HAE报告的管理方法包括培养安全和透明的文化,实施标准化报告系统,为医护人员提供教育和培训,建立反馈机制,对报告的事件进行稳健分析,推动持续改进,并确保透明度和问责制。
    BACKGROUND: The healthcare adverse event (HAE) reporting framework is more than just a tool. It is a crucial pillar in our pursuit of patient safety, quality improvement, trust maintenance, regulatory compliance, and ethical standards in healthcare delivery.
    OBJECTIVE: To assess healthcare workers\' satisfaction with the HAE reporting framework and the management approach towards such reporting in the emergency department of rural government hospitals by conducting a satisfaction survey.
    METHODS: This prospective observational research was conducted in the Department of Emergency Medicine of the Uttar Pradesh University of Medical Sciences, Saifai, and adjoining district hospitals from November 2023 to January 2024. The study involved 320 healthcare professionals working in the emergency department. The quantitative survey research used a questionnaire and a quality Likert scale response. The data were analyzed on an ordinal measurement scale using nonparametric statistical methods. The sample data were analyzed using frequency tables, percentage pie charts, and comparison bar graphs. In nonparametric statistical tests, the one-sample Wilcoxon signed rank test was used to infer the population\'s central tendency, and the Kruskal-Wallis test was used to make inferences about the population categories.
    RESULTS: The satisfaction of healthcare professionals with the HAE reporting framework and the management approach was diverse. When surveyed about the HAE reporting framework in the emergency department, out of the 320 healthcare professionals, 50% (161) expressed dissatisfaction, 47% (149) were satisfied, and 3% (10) did not comment. Paramedics were most dissatisfied (61% of 133). When asked about the management approach while dealing with such reporting, 50% (159) were satisfied, 46% (147) were unsatisfied, and 4% (14) did not comment. On comparing professions, 43% (29) of 33 doctors and 62% (83) of 133 paramedics were unsatisfied, giving a poor response. Additionally, 61% (72) of the 119 nursing staff were satisfied. The non-parametric inferential tests yielded a p-value of less than 0.001 for both questions, indicating a notable difference in the population\'s response to the HAE reporting framework and management approach. On pairwise comparison, there was a significant difference in perception (p<0.001) between the occupation groups, except for doctors and paramedics (p = 0.638) in the HAE reporting framework.
    CONCLUSIONS: By encouraging reporting, standardizing processes, analyzing incidents thoroughly, and using data-driven insights to inform improvement efforts, healthcare organizations can enhance patient safety, improve quality of care, and prevent future adverse events. The management approach to HAE reporting involves fostering a culture of safety and transparency, implementing standardized reporting systems, providing education and training to healthcare staff, establishing feedback mechanisms, conducting robust analysis of reported events, promoting continuous improvement, and ensuring transparency and accountability.
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  • 文章类型: Journal Article
    背景:口腔鳞状细胞癌(OSCC)是全球最常见的癌症之一。OSCC诊断的延迟可能对管理和患者预后产生重大影响。口腔管理中最关键的因素之一是及时的组织病理学最终诊断。周转时间(TAT)被认为是质量性能评估的最重要组成部分。尽管计算机化取得了进步,但许多实验室仍在努力改善其TAT,运输系统,和分析技术。目的:本研究旨在评估OSCC病例的TAT,评估平均TAT周期,评估任何TAT延迟,并探讨TAT延误背后的原因。材料和方法:Saveetha牙科学院和医院的OSCC报告,钦奈,从2022年1月1日至2022年12月31日的一年内,从牙科信息档案软件(DIAS)检索,并记录了平均TAT。Further,还观察到TAT延迟的病例数,列出了他们拖延的原因。使用IBMSPSSStatisticsforWindows执行描述性统计和图形表示,V.23.0(IBM公司,Armonk,NY,美国)。进行单向ANOVA,其中显著性设定为小于0.05的p值。
    结果:检索到230例OSCC病例,并纳入本研究的TAT评估。230例,161例(70%)为切口活检,69例(30%)为切除活检。只有7例(4%)切口病例和7例(10%)切除活检显示TAT延迟。TAT延迟的最常见原因是需要更深的切片和骨标本的脱钙。在161例切口病例中,只有48人(29%)接受了切除和进一步治疗。在69例切除病例中,有21例(30%)是来自其他私人机构的转介病例。12个月的总平均TAT对于切开活检为3.24±0.41天,对于切除活检为11.88±2.07天。单因素方差分析显示统计学显著的p值小于0.00001。
    结论:我们的研究揭示了TAT延迟的具体挑战和改善TAT的机会。这可以导致OSCC报告的更快的TAT,进一步改善患者护理,并启用及时治疗。这项研究量化了OSCC病例的TAT,并确定了工艺改进的关键领域。这些发现可以为简化诊断工作流程的策略提供信息,减少延误,并最终提高对OSCC患者的及时护理。
    BACKGROUND: Oral squamous cell carcinoma (OSCC) is one of the most common cancers worldwide. A delay in the diagnosis of OSCC can have a drastic impact on management and patient outcomes. One of the most crucial elements in oral management is the timely histopathological final diagnosis. Turnaround time (TAT) is regarded as the most important component of the quality performance evaluation. Many labs have struggled to improve their TATs despite advancements in computerization, transport systems, and analytical technologies.  Aim: This study aimed to assess the TAT of OSCC cases, assess the mean TAT period, evaluate any TAT delays, and explore the reasons behind the TAT delays.  Materials and methods: OSCC reports in Saveetha Dental College and Hospitals, Chennai, for one year from January 1, 2022, to December 31, 2022, were retrieved from the Dental Information Archival Software (DIAS), and the mean TAT was noted. Further, the number of cases with delay in TAT was also observed, and the reason for their delay was listed. Descriptive statistics and graphical representation were performed utilizing IBM SPSS Statistics for Windows, V. 23.0 (IBM Corp., Armonk, NY, USA). One-way ANOVA was performed with a significance set at a p-value less than 0.05.
    RESULTS: 230 OSCC cases were retrieved and included in the TAT evaluation for this study. Among 230 cases, 161 (70%) were incisional and 69 (30%) were excisional biopsies. Only seven (4%) incisional cases and seven (10%) excisional biopsies showed a delay in TAT. The most common reason for the delay in TAT was the requirement for deeper sections and decalcification of bone specimens. Out of 161 incisional cases, only 48 (29%) have undergone excision and further treatment. Twenty-one out of 69 (30%) excisional cases were found to be referral cases from other private institutions. The overall average TAT for 12 months was 3.24 ± 0.41 days for incisional biopsies and 11.88 ± 2.07 days for excisional biopsies. One-way ANOVA revealed a statistically significant p-value of less than 0.00001.
    CONCLUSIONS: Our study sheds light on specific challenges in TAT delay and opportunities for the improvement of TAT. This can result in faster TAT of OSCC reports, further improve patient care, and enable prompt treatment. This study quantified the TAT for OSCC cases and identified critical areas for process improvement. The findings can inform strategies to streamline diagnostic workflows, reduce delays, and ultimately improve the timely delivery of care to patients with OSCC.
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  • 文章类型: Journal Article
    随着联邦战略计划优先考虑增加生物医学劳动力的多样性,和STEM培训和外展计划寻求从历史上代表性不足的人群中招募和留住学生,有必要询问传统的人口统计学描述符,并仔细考虑获取人口统计学数据的最佳做法。为了加快这项工作,以公平为重点的研究人员和STEM计划的领导者召集起来研究测量人口变量的方法。性别,种族/民族,残疾,鉴于联邦资助机构的关注重点,处境不利的背景被优先考虑。少数性别类别,性(倾向)少数,和性别少数群体(SSGM)应包括在STEM计划收集的人口统计数据中,与白宫行政命令和联邦报告的建议一致。我们的手稿为人口统计问题提供了可操作的措辞,并建议在学生服务计划中使用。包容性人口统计数据允许识别被排除在外的个人,边缘化,或者聚合不当,提高解决生物医学研究培训不平等问题的能力。由于学员不能平等地进入培训项目,住宿,或准备,包容性人口措施可以欢迎学员,并告知一套细致入微的计划成果,以促进交叉性研究,以支持在生物医学研究中招募和保留代表性不足的学生。
    As federal strategic plans prioritize increasing diversity within the biomedical workforce, and STEM training and outreach programs seek to recruit and retain students from historically underrepresented populations, there is a need for interrogation of traditional demographic descriptors and careful consideration of best practices for obtaining demographic data. To accelerate this work, equity-focused researchers and leaders from STEM programs convened to examine approaches for measuring demographic variables. Gender, race/ethnicity, disability, and disadvantaged background were prioritized given their focus by federal funding agencies. Categories of sex minority, sexual (orientation) minority, and gender minority (SSGM) should be included in demographic measures collected by STEM programs, consistent with recommendations from White House Executive Orders and federal reports. Our manuscript offers operationalized phrasing for demographic questions and recommendations for use across student-serving programs. Inclusive demographics permit the identification of individuals who are being excluded, marginalized, or improperly aggregated, increasing capacity to address inequities in biomedical research training. As trainees do not enter training programs with equal access, accommodations, or preparation, inclusive demographic measures can welcome trainees and inform a nuanced set of program outcomes that facilitate research on intersectionality to support the recruitment and retention of underrepresented students in biomedical research.
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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
    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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