Study design

研究设计
  • 文章类型: Journal Article
    提出了移情能力来影响从创伤暴露到精神病理学的轨迹。然而,缺乏解决同情在与战争有关的创伤经历不同的难民中的作用的研究。这可能与在规划和执行此类研究时要考虑的方面的建议缺失有关。在本方法论论文中,因此,我们分享了我们在设计和实施战争相关创伤相互关系研究方面的经验,创伤后应激障碍,以及以难民或移民身份进入德国的阿拉伯语国家的个人的同理心。具体而言,我们反思与实验组的选择和移情措施有关的决定,并描述招聘过程中遇到的意外问题,筛选和测试。总的来说,我们建议应用多方法方法(即,问卷的组合,行为和生物学措施),以全面了解同理心的不同方面。Further,我们强调,不仅要考虑难民,但移民也可能经历过与战争有关的创伤。除此之外,我们建议咨询感兴趣的研究人群的个人进行仪器翻译,实现有效的招聘策略,并确保测试程序对参与者过去的经验和当前的需求敏感。我们希望分享这些见解将使有兴趣进行基础和干预研究的研究人员受益,这些研究旨在改善遭受战争相关创伤的个人的心理健康。
    Empathic abilities are proposed to affect the trajectory from trauma exposure to psychopathology. Yet, studies addressing the role of empathy in refugees with diverse experiences of war-related trauma are lacking. This may relate to missing recommendations on aspects to consider in the planning and execution of such a study. In the present methodological paper, we hence share our experiences in designing and implementing a study on the interrelations of war-related trauma, post-traumatic stress disorder, and empathy in individuals from Arabic-speaking countries who had entered Germany as refugees or migrants. In specific, we reflect on decisions related to the choice of experimental groups and measures of empathy, and describe unanticipated problems encountered during recruitment, screening and testing. Overall, we recommend applying a multi-method approach (i.e., a combination of questionnaire, behavioral and biological measures) to gain a comprehensive picture of the different facets of empathy. Further, we stress the importance to consider that not only refugees, but also migrants may have experienced war-related trauma. Beyond that, we advise to consult individuals of the study population of interest for the translation of instruments, realization of effective recruitment strategies, and to ensure that the testing procedures are sensitive to participants\' past experiences and current needs. We hope that sharing these insights will benefit researchers interested in conducting basic and intervention research aimed at improving the mental health of individuals exposed to war-related trauma.
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  • 文章类型: Journal Article
    电子健康记录(EHR)越来越被认为是临床研究中招募患者的一种具有成本效益的资源。然而,如何从数百万个体中最佳地选择一个队列来回答一个感兴趣的科学问题仍不清楚.考虑一项研究来估计昂贵结果的平均值或平均差。预测结果的廉价辅助协变量通常可以在患者的健康记录中获得,提供了一个有选择地招募病人的机会,这可能会提高下游分析的效率。在本文中,我们提出了一种两阶段采样设计,该设计利用了EHR数据中辅助协变量的可用信息。使用EHR数据进行多相采样的一个关键挑战是潜在的选择偏差,因为EHR数据不一定代表目标人群。扩展有关两阶段采样设计的现有文献,我们得出了一种最佳的两阶段抽样方法,该方法可以提高随机抽样的效率,同时考虑到EHR数据中潜在的选择偏差。我们通过模拟研究和利用密歇根基因组学计划的数据评估美国成年人高血压患病率的应用,证明了我们的采样设计的效率提高。密歇根医学的纵向生物储物库。
    Electronic health records (EHRs) are increasingly recognized as a cost-effective resource for patient recruitment in clinical research. However, how to optimally select a cohort from millions of individuals to answer a scientific question of interest remains unclear. Consider a study to estimate the mean or mean difference of an expensive outcome. Inexpensive auxiliary covariates predictive of the outcome may often be available in patients\' health records, presenting an opportunity to recruit patients selectively, which may improve efficiency in downstream analyses. In this paper we propose a two-phase sampling design that leverages available information on auxiliary covariates in EHR data. A key challenge in using EHR data for multiphase sampling is the potential selection bias, because EHR data are not necessarily representative of the target population. Extending existing literature on two-phase sampling design, we derive an optimal two-phase sampling method that improves efficiency over random sampling while accounting for the potential selection bias in EHR data. We demonstrate the efficiency gain from our sampling design via simulation studies and an application evaluating the prevalence of hypertension among U.S. adults leveraging data from the Michigan Genomics Initiative, a longitudinal biorepository in Michigan Medicine.
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  • 文章类型: Journal Article
    临床前寿命研究的分析通常假设来自共同饲养动物的结果数据是独立的。在实践中,治疗,如控制喂养或推定的延长寿命的化合物,适用于整个住房单元,因此,结果可能在住房单位内相关。我们考虑班级内(这里,笼内)在三个已发表的和两个未发表的关于老年小鼠的寿命研究中的相关性,这些研究涵盖了2万多个观察结果。我们证明了常见分析技术背后的独立性假设在这些数据中并不成立,特别是与虚弱相关的特征。我们描述和演示了可用于适应本研究设计的各种分析工具,并强调了标准方差分量模型的局限性(即,线性混合模型),这是处理相关错误的常用统计工具。通过模拟,我们研究了与这些案例研究中观察到的相似大小的笼内相关性导致的统计偏差,并讨论了对功效和可重复性的影响.
    Analysis of preclinical lifespan studies often assume that outcome data from co-housed animals are independent. In practice, treatments, such as controlled feeding or putative life-extending compounds, are applied to whole housing units, and as a result the outcomes are potentially correlated within housing units. We consider intra-class (here, intra-cage) correlation in three published and two unpublished lifespan studies of aged mice encompassing more than 20 thousand observations. We show that the independence assumption underlying common analytic techniques does not hold in these data, particularly for traits associated with frailty. We describe and demonstrate various analytical tools available to accommodate this study design and highlight a limitation of standard variance components models (i.e., linear mixed models) which are the usual statistical tool for handling correlated errors. Through simulations, we examine the statistical biases resulting from intra-cage correlations with similar magnitudes as observed in these case studies and discuss implications for power and reproducibility.
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  • 文章类型: Journal Article
    鼻咽癌(NPC)患者的生存率明显提高,但是对于它们是否可以被认为治愈没有共识。我们旨在确定在当代治疗领域中NPC患者是否可以实现统计治愈。
    这项回顾性多中心研究纳入了2007年至2020年来自中国非地方性和地方性地区的6315例非转移性鼻咽癌患者。我们应用混合和非混合治愈模型,通过纳入一般人群的背景死亡率来估计治愈概率和治愈时间,按性别匹配,年龄,诊断一年。
    将死亡视为未治愈的事件,NPC患者达到与一般人群相当的预期寿命的概率为78.1%.将进展视为未治愈的事件,患者达到与普通人群相同的无进展预期寿命的可能性为72.4%.对于个人来说,实现治愈的概率是有条件的和时间依赖性的,需要大约7.1和4.7年,95%的确定性,分别。未治愈患者的相应治愈时间为8.9年和6.8年,分别。治愈概率与年龄相关,东部肿瘤协作组评分,TNM分期,爱泼斯坦-巴尔病毒的DNA拷贝,和乳酸脱氢酶.5年总生存期/无进展生存期和治愈分数之间的相关性非常好。
    在接受现代治疗方式的NPC患者中,统计治愈是可能实现的。结果对临床实践和患者观点都具有重要的潜在意义。
    国家高级医院临床研究资助;北京喜思客临床肿瘤学研究基金会;北京希望跑基金。
    UNASSIGNED: The survival rates of patients with nasopharyngeal carcinoma (NPC) have improved significantly, but there is no consensus on whether they can be considered cured. We aimed to determine whether a statistical cure could be achieved for patients with NPC in the contemporary therapeutic landscape.
    UNASSIGNED: This retrospective multicenter study enrolled 6315 patients with nonmetastatic NPC from nonendemic and endemic regions of China from 2007 to 2020. We applied mixture and nonmixture cure models to estimate the cure probabilities and cure times by incorporating background mortality for the general population, matching by gender, age, and diagnosed year.
    UNASSIGNED: With death as the uncured event, the probability of patients with NPC achieving a life expectancy at par with the general population was 78.1%. Considering progression as the uncured event, the likelihood of patients attaining a life expectancy without progression equivalent to that of the general population was 72.4%. For individuals, the probabilities of achieving cure were conditional and time-dependent, requiring approximately 7.1 and 4.7 years with 95% certainty, respectively. The corresponding cure times for uncured patients were 8.9 and 6.8 years, respectively. The cure probability was correlated with age, Eastern Cooperative Oncology Group score, TNM staging, Epstein-Barr virus DNA copies, and lactate dehydrogenase. The correlation was excellent between 5-year overall survival/progression-free survival and cure fractions.
    UNASSIGNED: Statistical cure is potentially achievable among patients with NPC undergoing contemporary treatment modalities. The results hold significant potential implications for both clinical practice and patient perspectives.
    UNASSIGNED: National High Level Hospital Clinical Research Funding; Beijing Xisike Clinical Oncology Research Foundation; Beijing hope run fund.
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  • 文章类型: Journal Article
    成功的临床试验需要参与者,但是许多因素会阻碍有效的学习招募。为了更好地在客户拥有的动物中招募高质量的兽医临床试验,从而改善基于证据的患者护理和结果,集体需要分享和实施当前的招聘战略最佳做法。这些战略应利用招聘的整体观点,包括研究设计和后勤,代表参与,激励机制,人力资源,广告,和参与者保留。虽然人体临床试验数据和资源可以提供指导,还需要努力评估当前的实践和流程改进的机会,这是具体的兽医临床试验的进行。考虑到宠物作为自然发生的疾病模型和哨兵的力量,兽医临床研究的改进有可能告知人类健康结果。围绕兽医临床研究最佳实践和培训机会的持续合作发展将提高兽医临床试验团队的影响力,同时还促进了兽医专业人员的劳动力发展和替代职业道路。
    A successful clinical trial requires participants, but many factors can impede effective study recruitment. To better recruit for quality veterinary clinical trials in client-owned animals that lead to improved evidence-based patient care and outcomes, there is a collective need to share and implement current best practices for recruitment strategies. These strategies should utilize a holistic view of recruitment, encompassing study design and logistics, representative participation, incentives, personnel resources, advertising, and participant retention. Although human clinical trial data and resources can provide guidance, effort also needs to be put into evaluating current practices and opportunities for process improvement that are specific to the conduct of veterinary clinical trials. Considering the power of pets as naturally occurring models of disease and as sentinels, improved conduct of veterinary clinical research has the potential to inform human health outcomes. Continued development of collaborations surrounding best practices and training opportunities in veterinary clinical research will improve the impact of veterinary clinical trials teams, while also promoting workforce development and alternate career paths for veterinary professionals.
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  • 文章类型: Journal Article
    背景:研究已经确定了恋爱关系对个体发病率和死亡率的影响。然而,关系运作之间的相互作用,情感过程,健康行为研究相对不足。在COVID-19大流行期间,关系过程可能会影响新的健康行为,如社交距离和掩蔽。
    目的:我们描述了设计,招募,以及关系的方法,风险认知,以及COVID-19大流行研究期间与癌症相关的行为。这项研究旨在了解关系和情感过程如何影响浪漫伴侣参与癌症预防行为以及COVID-19大流行引入或加剧的健康行为。
    方法:关系,风险认知,在COVID-19大流行研究期间,癌症相关行为使用在线调查方法招募和招募2组参与同居浪漫关系的个体,包括1组成组(n=223)和1组癌症幸存者(n=443)。调查评估在平均间隔5.57(SD3.14)周的2个时间点完成。评估的健康行为包括COVID-19疫苗接种和社交距离,身体活动,饮食,睡眠,酒精使用,和吸烟行为。我们还检查了关系因素,心理困扰,家庭混乱。
    结果:数据收集发生在2021年10月至2022年8月之间。在此期间,共有926名参与者参加,其中约三分之二来自英国(n=622,67.8%),三分之一来自美国(n=296,32.2%);约三分之二已婚(n=608,66.2%),三分之一是未婚夫妇(n=294,32%).在队列1和2中,平均年龄分别约为34岁和50岁。在队列1的478名参与者中,有19名(4%)被确定为西班牙裔或拉丁裔/a,79(17%)为非西班牙裔亚洲人,40(9%)是非西班牙裔黑人或非裔美国人,和306(64%)为非西班牙裔白人;62(13%)参与者确定他们的性取向为双性恋或泛性,359(75.1%)为异性恋或异性恋,和53(11%)为同性恋。在队列2中,在440名参与者中,13(3%)被确定为西班牙裔或拉丁裔/a,8(2%)为非西班牙裔亚洲人,5(1%)是非西班牙裔黑人或非裔美国人,和398(90.5%)为非西班牙裔白人;41(9%)参与者确定他们的性取向为双性恋或泛性,384(87.3%)为异性恋或异性恋,13(3%)是同性恋。个人的总体入学率为66.14%,总体完成率为80.08%。
    结论:我们讨论了收集在线调查数据的最佳实践,用于研究人际关系和健康,与COVID-19大流行有关的挑战,招募代表性不足的人口,和二元组的注册。建议包括进行试点研究,为边缘化或服务不足的人群提供额外的数据收集时间,盈余筛选,以说明二元组合内的预期减员,以及计划dyad特定的数据质量检查。
    DERR1-10.2196/48516。
    BACKGROUND: Research has established the effects of romantic relationships on individuals\' morbidity and mortality. However, the interplay between relationship functioning, affective processes, and health behaviors has been relatively understudied. During the COVID-19 pandemic, relational processes may influence novel health behaviors such as social distancing and masking.
    OBJECTIVE: We describe the design, recruitment, and methods of the relationships, risk perceptions, and cancer-related behaviors during the COVID-19 pandemic study. This study was developed to understand how relational and affective processes influence romantic partners\' engagement in cancer prevention behaviors as well as health behaviors introduced or exacerbated by the COVID-19 pandemic.
    METHODS: The relationships, risk perceptions, and cancer-related behaviors during the COVID-19 pandemic study used online survey methods to recruit and enroll 2 cohorts of individuals involved in cohabiting romantic relationships, including 1 cohort of dyads (n=223) and 1 cohort of cancer survivors (n=443). Survey assessments were completed over 2 time points that were 5.57 (SD 3.14) weeks apart on average. Health behaviors assessed included COVID-19 vaccination and social distancing, physical activity, diet, sleep, alcohol use, and smoking behavior. We also examined relationship factors, psychological distress, and household chaos.
    RESULTS: Data collection occurred between October 2021 and August 2022. During that time, a total of 926 participants were enrolled, of which about two-thirds were from the United Kingdom (n=622, 67.8%) and one-third were from the United States (n=296, 32.2%); about two-thirds were married (n=608, 66.2%) and one-third were members of unmarried couples (n=294, 32%). In cohorts 1 and 2, the mean age was about 34 and 50, respectively. Out of 478 participants in cohort 1, 19 (4%) identified as Hispanic or Latino/a, 79 (17%) as non-Hispanic Asian, 40 (9%) as non-Hispanic Black or African American, and 306 (64%) as non-Hispanic White; 62 (13%) participants identified their sexual orientation as bisexual or pansexual, 359 (75.1%) as heterosexual or straight, and 53 (11%) as gay or lesbian. In cohort 2, out of 440 participants, 13 (3%) identified as Hispanic or Latino/a, 8 (2%) as non-Hispanic Asian, 5 (1%) as non-Hispanic Black or African American, and 398 (90.5%) as non-Hispanic White; 41 (9%) participants identified their sexual orientation as bisexual or pansexual, 384 (87.3%) as heterosexual or straight, and 13 (3%) as gay or lesbian. The overall enrollment rate for individuals was 66.14% and the overall completion rate was 80.08%.
    CONCLUSIONS: We discuss best practices for collecting online survey data for studies examining relationships and health, challenges related to the COVID-19 pandemic, recruitment of underrepresented populations, and enrollment of dyads. Recommendations include conducting pilot studies, allowing for extra time in the data collection timeline for marginalized or underserved populations, surplus screening to account for expected attrition within dyads, as well as planning dyad-specific data quality checks.
    UNASSIGNED: DERR1-10.2196/48516.
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  • 文章类型: Journal Article
    刑事诉讼门槛下的政治压制是过去和现在的现象,以专制为主,政权。这种所谓的安静镇压包括限制言论自由等措施,监视(感知的)政治对手,或者谣言传播到社会孤立的目标。这种慢性压力的经历在受影响的个体中显示出重大的心理和生理健康后果。然而,社会对安静镇压措施的认识仍然有限,阻碍受害者获得支持和使医疗干预复杂化。在当前的论文中,我们提出了一项研究的设计,该研究是针对在前德意志民主共和国(GDR)中忍受安静镇压措施的个人进行的,与前苏联密切相关的社会主义国家。我们讨论了在研究过程中遇到的挑战,并提出找到的解决方案。尽管每个研究人群都有其独特的挑战和需求,我们希望在安静的政治镇压领域为未来的敏感研究提供信息。鉴于对这一现象的理解有限,迫切需要进一步调查,以改善对过去和未来受害者的接受度和照顾。
    Political repression beneath the threshold of criminal prosecution is a phenomenon of past and present, predominantly authoritarian, regimes. This so-called quiet repression includes measures such as the limitation of freedom of speech, surveillance of (perceived) political opponents, or the spreading of rumors to socially isolate targets. Such experiences of chronic stress show significant psychological and physiological health consequences in affected individuals. However, societal awareness of quiet repression measures remains limited, hindering victims\' access to support and complicating healthcare interventions. In the current paper, we present the design of a study conducted with individuals who endured quiet repression measures in the former German Democratic Republic (GDR), a socialist state closely aligned with the former Soviet Union. We discuss the challenges encountered over the course of the study, and present the solutions found. Although every study population has their unique challenges and needs, we wish to inform future sensitive research within the realm of quiet political repression. Given the limited understanding of the phenomenon, there is a pressing need for further investigation aiming to improve acceptance and care for past and future victims.
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  • 文章类型: Journal Article
    背景:故事完成方法提供了一种进行定性研究的不同方式。我们注意到这种方法在健康相关研究中的迅速普及,尽管在此类研究的最佳实践方面仍有许多有待谈判。本范围审查旨在提供有关研究人员如何在卫生服务研究中使用故事完成方法的综合信息。我们为研究和实践提供了启示,以供学术界进一步讨论。
    方法:我们使用JBI方法进行范围审查。截至2023年3月1日,共搜索了六个数据库的已发表文献:Medline,Embase,CINAHL,PsycINFO,SAGE期刊在线数据库,和SAGE研究方法。我们在卫生服务研究中使用故事完成方法纳入了任何研究设计的主要研究。
    结果:共纳入17项研究。研究结果表明,故事完成方法对敏感话题的研究很有用,并提供使用比较研究设计和大样本量,这可能是传统的定性研究方法所困难的。超过80%的纳入研究使用故事完成作为唯一的方法。然而,从这种方法收集的数据在可以得出的推论方面是有限的;参与者反应的丰富程度可能差异很大.不到30%的纳入研究报告了故事情节的试点。大多数研究都是在线进行的,并进行了定性分析,尽管故事情节的设计和样本量差异很大。
    结论:故事完成方法,伴随着它对更大样本量的支持,比较研究设计,简化数据收集是卫生服务研究的创新和有用的独立或辅助定性方法。
    BACKGROUND: The story completion method provides a different way of doing qualitative research. We note the emergent popularity of this method in health-related research, while much remains to be negotiated in terms of best practices for such studies. This scoping review aims to provide a synthesis on how researchers have used the story completion method in health services research. We offer implications for research and practice for further discussion by the scholarly community.
    METHODS: We used the JBI methodology for scoping reviews. Six databases were searched for published literature till March 1, 2023: Medline, Embase, CINAHL, PsycINFO, SAGE Journals Online databases, and SAGE Research Methods. We included primary studies of any study design using the story completion method in health services research.
    RESULTS: A total of 17 studies were included. Findings suggest that the story completion method is useful for research on sensitive topics, and affords the use of comparative study designs and large sample sizes which may be difficult with conventional qualitative research methods. More than 80% of included studies used story completion as the sole method. However, the data collected from this method were limited in terms of the inferences that can be drawn; and richness of participant responses may vary widely. Less than 30% of included studies reported piloting of the story stems. Most studies were conducted online and analyzed qualitatively, though the story stem design and sample size varied widely.
    CONCLUSIONS: The story completion method, with its attendant affordances for larger sample sizes, comparative study designs, and streamlined data collection is an innovative and useful stand-alone or adjunct qualitative method for health services research.
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  • 文章类型: Editorial
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