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A Ten-Year Cohort Study on the Stability and Trajectories of Psychiatric Diagnosis in Adolescents and Young Adults in Lazio, Italy 意大利拉齐奥青少年和年轻人精神病诊断的稳定性和轨迹的十年队列研究
IF 2.4 3区 医学 Q2 PSYCHIATRY Pub Date : 2025-05-12 DOI: 10.1002/mpr.70023
Anna Forastiere, Enrico Calandrini, Giulia Cesaroni, Anna Maria Bargagli, Nera Agabiti

Introduction

We aimed to evaluate the diagnostic stability of a large spectrum of psychiatric diagnoses in adolescents and young adult patients attending specialised facilities in the Lazio Region (Italy).

Methods

A total of 3871 subjects (11–35 years) at their first hospitalisation with a psychiatric diagnosis were selected and followed up for 10 years on subsequent hospital admissions to psychiatric care.

Results

A total of 1145 patients were readmitted to a hospital for a psychiatric disorder in the following 10 years. Among these subjects, the concordance between the first and last diagnosis was 57.8% with a weighted kappa of 0.47 (95% CI: 0.42–0.51); the repeated stability (the same diagnosis in at least 75% of admissions) was 31.2%. The diagnostic categories with the highest values of prospective concordance and kappa were schizophrenia spectrum and other functional psychoses (70%, kappa 0.53), substance use disorders (54%, kappa 0.57), and eating disorders (80.9%, kappa 0.76).

Conclusions

In a population study, the stability over time of the first psychiatric diagnosis in a hospital varied according to the specific diagnostic categories, and overall, it was lower than previously reported. The trajectories were disorder-specific, and the stability was influenced by several factors, including the individuals' characteristics, the disorder's severity, and the diagnostic setting.

我们的目的是评估在拉齐奥地区(意大利)专门机构就诊的青少年和年轻成人患者的大范围精神病诊断的稳定性。方法选取首次住院的3871例(11 ~ 35岁)精神科患者,随访10年。结果在随后的10年中,共有1145例患者因精神障碍再次入院。其中首次诊断与最后诊断的一致性为57.8%,加权kappa为0.47 (95% CI: 0.42 ~ 0.51);重复稳定性(至少75%的入院患者诊断相同)为31.2%。前瞻性一致性和kappa值最高的诊断类别是精神分裂症谱系和其他功能性精神病(70%,kappa 0.53)、物质使用障碍(54%,kappa 0.57)和饮食障碍(80.9%,kappa 0.76)。在一项人口研究中,根据具体的诊断类别,医院首次精神病诊断的稳定性随着时间的推移而变化,总体而言,比以前报道的要低。这些轨迹是疾病特异性的,其稳定性受到几个因素的影响,包括个体的特征、疾病的严重程度和诊断环境。
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引用次数: 0
Short Forms of the German Revised Children's Anxiety and Depression Scale (RCADS)–Validation and Normative Data of the 11- and 25-Item Versions 德国修订儿童焦虑与抑郁量表(RCADS)简表——11题和25题版本的验证和规范性数据
IF 2.4 3区 医学 Q2 PSYCHIATRY Pub Date : 2025-04-26 DOI: 10.1002/mpr.70022
Susanne Grothus, Ariane Sommer, Benedikt B. Claus, Lorin Stahlschmidt, Lea Höfel, Bruce F. Chorpita, Julia Wager

Objectives

This study assesses the reliability and validity of two short forms of the German Revised Children’s Anxiety and Depression Scale (RCADS 11- and 25-item versions) and provides normative data.

Methods

Data were collected from a representative sample of N = 1562 German schoolchildren and N = 757 pediatric chronic pain patients (ages 8–17).

Results

Cronbach's α demonstrated acceptable to good internal consistency for the total score as well as the depression and anxiety scales. Confirmatory factor analysis (CFA) demonstrated acceptable to good model fit for both a 2-factor structure (RCADS-11) and a higher-order structure (RCADS-25). Multi-group CFAs demonstrated similar model structures across the school and pediatric chronic pain samples. Convergent validity was supported by moderate to high negative correlations with health-related quality of life and a high positive correlation with functional impairment. Girls—and to some extent, adolescents – scored significantly higher on anxiety and depression scales. The short versions demonstrated excellent agreement with the original 47-item RCADS (0.78 ≤ Cohen’s κ ≤ 1.0). German normative data are provided.

Conclusion

The short versions of the German RCADS are reliable and valid instruments for assessing anxiety and depressive symptoms in children and adolescents.

目的本研究评估德国儿童焦虑与抑郁量表(RCADS 11项和25项版本)的信度和效度,并提供规范性数据。方法收集代表性样本N = 1562名德国学龄儿童和N = 757名8-17岁儿童慢性疼痛患者的数据。结果总分、抑郁量表和焦虑量表的Cronbach's α具有良好的内部一致性。验证性因子分析(CFA)证明了两因素结构(RCADS-11)和高阶结构(RCADS-25)的良好模型拟合是可以接受的。多组cfa在学校和儿童慢性疼痛样本中显示出相似的模型结构。收敛效度与健康相关的生活质量呈中等至高度负相关,与功能障碍呈高度正相关。女孩——在某种程度上,青少年——在焦虑和抑郁量表上的得分明显更高。短版本与原始的47项RCADS具有良好的一致性(0.78≤Cohen’s κ≤1.0)。提供了德国的规范性数据。结论德国简易RCADS量表是评估儿童和青少年焦虑和抑郁症状的可靠、有效的工具。
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引用次数: 0
Modification of the Adjustment Disorder New Module20 (ADNM-20) for Use in Military Environments (ADNM-20-MIL): A Delphi and Pilot Study 修改适应障碍新模块 20 (ADNM-20) 以用于军事环境 (ADNM-20-MIL):德尔菲和试点研究
IF 2.4 3区 医学 Q2 PSYCHIATRY Pub Date : 2025-04-11 DOI: 10.1002/mpr.70021
Jouhayna Bajjani-Gebara, Dawnkimberly Hopkins, Joan Wasserman, Ryan Landoll, Margaux Keller

Objectives

Despite its high prevalence and strong linkages with dangerous health outcomes, research on Adjustment Disorder (AjD) is hindered by lack of diagnostic clarity. AjD is categorized as a stress-related disorder, highlighting the important role of the stressor(s) on AjD symptom onset and severity. The military community shows increased risk for AjD, and existing tools do not capture the stressors most relevant and appropriate to this unique community. A diagnostic assessment tool developed specifically for this specialized population may provide critical capability to clinical assessment.

Methods

A Delphi method was used to create a military-specific version of the standard assessment for Adjustment Disorders (ADNM-20), named ADNM-20-MIL. This tool was pilot-tested in a sample of U.S. Active Duty Service Members (ADSMs) with AjD diagnoses.

Results

Throughout the Delphi process, military-specific stressors were identified and integrated into the ADNM-20-MIL, then refined and validated, ensuring their applicability and relevance to the military context.

Conclusions

The ADNM-20-MIL will enable timely diagnosis and targeted treatment for AjD, which remains a highly prevalent and destabilizing diagnosis in ADSMs.

尽管适应障碍(AjD)发病率高,且与危险的健康结果密切相关,但由于诊断不明确,对其的研究受到阻碍。AjD被归类为应激相关障碍,强调了应激源在AjD症状发作和严重程度中的重要作用。军事社区显示出AjD的风险增加,现有的工具没有捕捉到最相关和最适合这个独特社区的压力源。专门为这一特殊人群开发的诊断评估工具可能为临床评估提供关键能力。方法采用德尔菲法编制适应障碍评定标准(ADNM-20),命名为ADNM-20- mil。该工具在患有AjD诊断的美国现役军人(ADSMs)样本中进行了试点测试。在整个德尔菲过程中,军方特定的应激源被识别并整合到ADNM-20-MIL中,然后进行细化和验证,确保其适用性和相关性。结论ADNM-20-MIL能够及时诊断和靶向治疗AjD, AjD仍然是adsm中高度流行和不稳定的诊断。
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引用次数: 0
Psychometric Properties of MyCog 2.0: A Human-Centered Cognitive Screening Tool for Older Adults MyCog 2.0的心理测量特性:老年人以人为中心的认知筛选工具
IF 2.4 3区 医学 Q2 PSYCHIATRY Pub Date : 2025-04-07 DOI: 10.1002/mpr.70020
Stephanie Ruth Young, Yusuke Shono, Katherina K. Hauner, Jiwon Kim, Elizabeth McManus Dworak, Greg Joseph Byrne, Callie Madison Jones, Julia Noelani Yoshino Benavente, Michael S. Wolf, Cindy J. Nowinski

Objectives

Self-administered, user-friendly apps that can detect initial symptoms of cognitive impairment have enormous potential to improve early detection of cognitive decline. We examine the psychometric properties of the redesigned version of MyCog, MyCog 2.0, an app-based tool for older adults that assesses executive function and episodic memory. MyCog 2.0 aims to improve usability while maintaining the psychometric validity demonstrated in the original version.

Methods

Feedback from clinicians and patients on MyCog was gathered to inform the human-centered design improvements of MyCog 2.0. To assess the psychometric properties of the improved tool, data from a community sample (n = 200; mean age = 73 years) who had completed MyCog 2.0 were compared to an age-matched sample who had completed the original MyCog. Internal consistency and construct validity were evaluated via confirmatory factor analysis. Bayesian differential item functioning was employed to evaluate the evidence for equivalence of MyCog and MyCog 2.0.

Results

Internal consistency was high for executive function and episodic memory tests (ωt = 0.84). A two-factor model showed excellent fit, demonstrating that tests measured two related yet distinct constructs, episodic memory and executive functioning, as expected. Differential item functioning between the two test versions was not observed for episodic memory performance or executive functioning accuracy; however, response time on five executive function items was found to differ across versions.

Conclusions

Findings support MyCog 2.0 as the first reliable self-administered cognitive screener designed specifically for ease of use among older adults. Findings support the internal consistency and construct validity of MyCog 2.0 and provide a foundation for the forthcoming clinical validation studies.

自我管理、用户友好的应用程序可以检测认知障碍的初始症状,在改善认知能力下降的早期检测方面具有巨大的潜力。我们研究了重新设计版本的MyCog的心理测量特性,MyCog 2.0是一种基于应用程序的老年人执行功能和情景记忆评估工具。myug 2.0旨在提高可用性,同时保持原始版本中所展示的心理测量效度。方法收集临床医生和患者对MyCog的反馈信息,对MyCog 2.0进行人性化设计改进。为了评估改进后的工具的心理测量特性,数据来自社区样本(n = 200;平均年龄= 73岁)完成了MyCog 2.0与年龄匹配的完成了原始MyCog的样本进行比较。通过验证性因子分析评估内部一致性和结构效度。采用贝叶斯差分项目函数对MyCog和MyCog 2.0的等效性证据进行评价。结果执行功能和情景记忆的内部一致性较高(ωt = 0.84)。一个双因素模型显示了极好的拟合,表明测试测量了两个相关但不同的结构,情景记忆和执行功能,正如预期的那样。在情景记忆表现和执行功能准确性方面,没有观察到两个测试版本的差异项目功能;然而,五个执行功能项目的反应时间在不同的版本中是不同的。结论:研究结果支持MyCog 2.0是第一个可靠的自我给药认知筛查,专为方便老年人使用而设计。研究结果支持了MyCog 2.0的内部一致性和结构效度,并为即将进行的临床验证研究提供了基础。
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引用次数: 0
Estimating Treatment Effect Heterogeneity in Psychiatry: A Review and Tutorial With Causal Forests 估计精神病学治疗效果的异质性:因果森林的回顾和指导
IF 2.4 3区 医学 Q2 PSYCHIATRY Pub Date : 2025-04-03 DOI: 10.1002/mpr.70015
Erik Sverdrup, Maria Petukhova, Stefan Wager

Background

Flexible machine learning tools are increasingly used to estimate heterogeneous treatment effects.

Aims

This paper gives an accessible tutorial demonstrating the use of the causal forest algorithm, available in the R package grf.

Summary

We start with a brief non-technical overview of treatment effect estimation methods, focusing on estimation in observational studies; the same techniques can also be applied in experimental studies. We then discuss the logic of estimating heterogeneous effects using the extension of the random forest algorithm implemented in grf. Finally, we illustrate causal forest by conducting a secondary analysis on the extent to which individual differences in resilience to high combat stress can be measured among US Army soldiers deploying to Afghanistan based on information about these soldiers available prior to deployment. We illustrate simple and interpretable exercises for model selection and evaluation, including targeting operator characteristics curves, Qini curves, area-under-the-curve summaries, and best linear projections.

Results

A replication script with simulated data is available at https://github.com/grf-labs/grf/tree/master/experiments/ijmpr.

灵活的机器学习工具越来越多地用于估计异质治疗效果。本文给出了一个可访问的教程,演示了R包grf中因果森林算法的使用。我们首先简要介绍治疗效果估计方法的非技术概述,重点是观察性研究中的估计;同样的技术也可以应用于实验研究。然后,我们讨论了利用grf中实现的随机森林算法的扩展来估计异构效应的逻辑。最后,我们根据部署到阿富汗的美国陆军士兵在部署前可获得的信息,对部署到阿富汗的美国陆军士兵在高战斗压力恢复力方面的个体差异进行了二次分析,从而说明了因果森林。我们举例说明了简单和可解释的模型选择和评估练习,包括目标操作员特征曲线,Qini曲线,曲线下面积总结和最佳线性预测。结果模拟数据的复制脚本可在https://github.com/grf-labs/grf/tree/master/experiments/ijmpr上获得。
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引用次数: 0
Prevalence Estimation Using a Depression Screening Tool in the National Health and Nutrition Examination Survey: Comparison of Different Cutoffs 在全国健康和营养检查调查中使用抑郁症筛查工具估计患病率:不同临界值的比较
IF 2.4 3区 医学 Q2 PSYCHIATRY Pub Date : 2025-04-03 DOI: 10.1002/mpr.70019
Ali Mertcan Köse, Paul Petzold, Dario Zocholl, Polychronis Kostoulas, Matthias Rose, Felix Fischer

Objectives

The National Health and Nutrition Examination Survey (NHANES) in the US relies on the depression screening tool PHQ-9 to assess depressive symptoms in the general population. For prevalence estimation, PHQ-9s imperfect diagnostic accuracy can be modeled with a Bayesian Latent Class Model. We investigate the impact of different cutoffs on prevalence estimation.

Methods

We used data from the 16-th wave of the National Health and Nutrition Examination Survey (NHANES). We assessed the joint posterior distribution to asssess the prevalence of major depression as well as sensitivity and specificity of the PHQ-9 at cutoffs 5 to 15. We also assessed the impact of weakly and strongly informative prevalence priors.

Results

Data from 9693 participants of the NHANES Wave 2019–2020 were analyzed. Under weakly informative prevalence priors, prevalence estimates ranged from 16.0% (95% CrI: 0.3%–87.8%) when using a cut-off of 5% to 3.9% (0.2%–12.7%) at 13. More informative prevalence priors led to narrower credible intervals, but the observed data was still in accordance with a wide range of possible MDD prevalence estimates.

Conclusions

Regardless of the cutoff and the prevalence prior chosen, prevalence estimation of major depressive disorders in the NHANES based on the PHQ-9 is imprecise.

美国国家健康与营养调查(NHANES)依靠抑郁症筛查工具PHQ-9来评估普通人群的抑郁症状。对于患病率估计,phq -9的不完美诊断准确性可以用贝叶斯潜类模型建模。我们研究了不同的截止值对患病率估计的影响。方法采用第16次全国健康与营养调查(NHANES)数据。我们评估了关节后分布,以评估重度抑郁症的患病率以及PHQ-9在临界值5至15的敏感性和特异性。我们还评估了弱和强信息流行先验的影响。结果分析了9693名NHANES Wave 2019-2020参与者的数据。在弱信息的患病率先验条件下,当使用5%的截止值时,患病率估计范围为16.0% (95% CrI: 0.3%-87.8%)至3.9%(0.2%-12.7%)。更多信息的患病率先验导致更窄的可信区间,但观察到的数据仍然符合广泛的可能的MDD患病率估计。结论无论临界值和先前选择的患病率如何,NHANES中基于PHQ-9的重性抑郁症患病率估计都是不精确的。
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引用次数: 0
IJMPR Didactic Paper: Weighting for Causal Inference in Mental Health Research IJMPR教学论文:心理健康研究中因果推理的权重
IF 2.4 3区 医学 Q2 PSYCHIATRY Pub Date : 2025-04-01 DOI: 10.1002/mpr.70018
Eric R. Cohn, José R. Zubizarreta

Objective

Inverse probability weighting is a fundamental and general methodology for estimating the causal effects of exposures and interventions, but standard approaches to constructing such weights are often suboptimal.

Methods

In this paper, we describe a recent approach for constructing such weights that directly balances covariates while optimizing the stability of the resulting weighting estimator.

Results

To illustrate the use of this approach in mental health research, we present an exploratory study of the effects of exposure to violence on the risk of suicide attempt.

Conclusions

The direct balancing approach to weighting should be given strong consideration in empirical research due to its robustness and transparency in building weighting estimators.

目的 反概率加权法是估算暴露和干预措施因果效应的一种基本通用方法,但构建此类权重的标准方法往往不够理想。 方法 在本文中,我们介绍了一种最新的构建此类权重的方法,该方法可直接平衡协变量,同时优化由此产生的权重估计器的稳定性。 结果 为了说明这种方法在心理健康研究中的应用,我们介绍了一项关于暴力暴露对自杀未遂风险影响的探索性研究。 结论 由于直接平衡加权法在构建加权估计器时具有稳健性和透明度,因此在实证研究中应重点考虑这种方法。
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引用次数: 0
Evaluating Problematic Smartphone Use Among Chinese Primary School Students Using SABAS: An IRT and Network Analysis 使用SABAS评估中国小学生智能手机使用问题:IRT和网络分析
IF 2.4 3区 医学 Q2 PSYCHIATRY Pub Date : 2025-04-01 DOI: 10.1002/mpr.70016
Siyang Liu, Qian Chen, Jiayang Li, Yimeng Zhu, Xiaorong Guo, Xin Zhao

Objectives

This study assessed the psychometric properties of the Smartphone Application-Based Addiction Scale (SABAS) among Chinese primary school students, focusing on validity, reliability, and factor structure using Item Response Theory (IRT) and Network Analysis (NA).

Methods

Data were collected from 1108 primary school students in China (52.98% female; ages 7–14 years; M = 10.58, SD = 0.99). SABAS was assessed using Item Response Theory (IRT) for factor structure, item parameters, cut-off scores, and reliability, while Differential Item Functioning (DIF) detected gender biases. Network Analysis (NA) examined the interrelationships among SABAS items.

Results

Confirmatory factor analysis supported SABAS's unidimensional structure (RMSEA = 0.055, CFI = 0.984, TLI = 0.973, SRMR = 0.025). IRT indicated high item discrimination (α = 1.47–2.47) and identified a cut-off score of 27, classifying 1.7% of students as high-risk for problematic smartphone use. Gender DIF was noted in item 6, with boys showing higher relapse tendencies (p < 0.05). NA highlighted the centrality of tolerance and withdrawal items.

Conclusions

SABAS is a reliable tool for assessing problematic smartphone use in Chinese primary school students, particularly those at moderate to high risk.

目的运用项目反应理论(IRT)和网络分析(NA)对中国小学生智能手机应用成瘾量表(SABAS)的效度、信度和因子结构进行评估。方法收集全国1108名小学生(女生52.98%;7-14岁;M = 10.58, sd = 0.99)。采用项目反应理论(IRT)评估SABAS的因素结构、项目参数、截止分数和信度,而差异项目功能(DIF)检测性别偏见。网络分析(NA)检验了SABAS项目之间的相互关系。结果验证性因子分析支持SABAS的单维结构(RMSEA = 0.055, CFI = 0.984, TLI = 0.973, SRMR = 0.025)。IRT显示高项目歧视(α = 1.47-2.47),并确定了27分的临界值,将1.7%的学生归类为问题智能手机使用的高风险学生。性别DIF在项目6中被注意到,男孩表现出更高的复发倾向(p <;0.05)。NA强调了耐受性和戒断项目的中心地位。结论SABAS是评估中国小学生智能手机使用问题的可靠工具,尤其是中高风险学生。
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引用次数: 0
Effect of the MyDéfi Smartphone Application on Binge Drinking Among University Students: Protocol of a Double-Blind Multicenter Prospective National Randomized Controlled Trial Using Phosphatidylethanol as a Biomarker—The SMARTBINGE Trial myd<s:1>智能手机应用程序对大学生酗酒的影响:一项以磷脂酰乙醇为生物标志物的双盲多中心前瞻性国家随机对照试验方案- SMARTBINGE试验
IF 2.4 3区 医学 Q2 PSYCHIATRY Pub Date : 2025-04-01 DOI: 10.1002/mpr.70014
Camille André, Pierre Sauton, Méléna Dreinaza, Momar Diouf, Sandra Bodeau, Margaret Martinetti, Raphaël Trouillet, Clara de Groote, Jean-Louis Nandrino, Adèle Alexandre, Farid Benzerouk, Fabien Gierski, Pascal Perney, Laure Grellet, Judith André, Mickael Naassila

Objective

The purpose of this paper is to describe a study protocol of a clinical trial exploring the effectiveness of the new mobile application MyDéfi proposing personalized feedback, on both alcohol consumption and quality of life, as well as the blood alcohol exposure biomarker phosphatidylethanol, in university students displaying binge drinking behavior.

Methods

This prospective national multicentric randomized, two-arm (1:1), double-blind controlled trial will recruit 628 students (aged 18–25 years) with binge drinking behavior. Participants will be randomized in the “intervention” group (personalized feedback) or the “control” group (generic feedback) and will undergo four monthly visits. Monthly dried blood spot sample for measuring phosphatidylethanol concentration and online questionnaires will be collected. Our primary objective is to assess the reduction weekly standard drinks, through self-report gathered via MyDéfi. Secondary objectives will evaluate the application's impact on the dosage of phosphatidylethanol blood concentration and on quality of life”.

Results

Recruitment started in March 2024 and will end in March 2026.

Conclusion

This study aims to determine the effectiveness of two versions of the same mobile application (generic vs. personalized feedback) on alcohol consumption in students displaying binge drinking behavior. The effectiveness of the application will be measured, with a secondary objective of quantifying phosphatidylethanol. Our study will open new perspectives on the use of digital interventions for students who do not actively seek treatment.

Trial Registration

Trial registration number (NCT06084832), the date of registration (10th October 2023) and when this was done (16th October 2023). https://clinicaltrials.gov/study/NCT06084832

本文的目的是描述一项临床试验的研究方案,该临床试验旨在探索新的移动应用程序myd在酗酒行为大学生的酒精消费和生活质量以及血液酒精暴露生物标志物磷脂酰乙醇方面提出个性化反馈的有效性。方法本前瞻性全国多中心、随机、双盲对照(1:1)试验将招募628名有酗酒行为的学生(18-25岁)。参与者将被随机分为“干预”组(个性化反馈)或“对照组”组(一般反馈),并将接受每月四次的访问。每月收集用于测量磷脂酰乙醇浓度的干血斑样本和在线问卷。我们的主要目标是通过mydsamfi收集的自我报告来评估每周标准饮料的减少。次要目标将评估应用对磷脂酰乙醇血药浓度和生活质量的影响。招募开始于2024年3月,将于2026年3月结束。本研究旨在确定同一移动应用程序的两个版本(通用与个性化反馈)对表现出酗酒行为的学生的酒精消费的有效性。将测量应用程序的有效性,第二个目标是定量磷脂酰乙醇。我们的研究将为那些不积极寻求治疗的学生提供使用数字干预的新视角。试验注册号(NCT06084832)、注册日期(2023年10月10日)和完成时间(2023年10月16日)。https://clinicaltrials.gov/study/NCT06084832
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引用次数: 0
Statistical methods to adjust for the effects on intervention compliance in randomized clinical trials where precision treatment rules are being developed 在制定精确治疗规则的随机临床试验中,调整干预依从性影响的统计方法。
IF 2.4 3区 医学 Q2 PSYCHIATRY Pub Date : 2025-01-08 DOI: 10.1002/mpr.70005
Nur Hani Zainal, Corina Benjet, Yesica Albor, Mauricio Nuñez-Delgado, Renato Zambrano-Cruz, Carlos C. Contreras-Ibáñez, Lorena Cudris-Torres, Francisco R. de la Peña, Noé González, José Benjamín Guerrero-López, Raúl A. Gutierrez-Garcia, Ana Lucía Jiménez-Peréz, Maria Elena Medina-Mora, Pamela Patiño, Pim Cuijpers, Sarah M. Gildea, Alan E. Kazdin, Chris J. Kennedy, Alex Luedtke, Nancy A. Sampson, Maria V. Petukhova, Jose R. Zubizarreta, Ronald C. Kessler

Background

Heterogeneity of treatment effects (HTEs) can occur because of either differential treatment compliance or differential treatment effectiveness. This distinction is important, as it has action implications, but it is unclear how to distinguish these two possibilities statistically in precision treatment analysis given that compliance is not observed until after randomization. We review available statistical methods and illustrate a recommended method in secondary analysis in a trial focused on HTE.

Methods

The trial randomized n = 880 anxious and/or depressed university students to guided internet-delivered cognitive behavioral therapy (i-CBT) or treatment-as-usual (TAU) and evaluated joint remission. Previously reported analyses documented superiority of i-CBT but significant HTE. In the reanalysis reported here, we used baseline (i.e., pre-randomization) covariates to predict compliance among participants randomized to guided i-CBT, generated a cross-validated within-person expected compliance score based on this model in both intervention groups, and then used this expected composite score as a predictor in an expanded HTE analysis.

Results

The significant intervention effect was limited to participants with high expected compliance. Residual HTE was nonsignificant.

Conclusions

Future psychotherapy HTE trials should routinely develop and include expected compliance composite scores to distinguish the effects of differential treatment compliance from the effects of differential treatment effectiveness.

背景:治疗效果的异质性(HTEs)可能由于治疗依从性的差异或治疗效果的差异而发生。这种区别是重要的,因为它具有行动意义,但目前尚不清楚如何在精确治疗分析中区分这两种可能性,因为直到随机化后才观察到依从性。我们回顾了现有的统计方法,并在一项针对HTE的试验中说明了一种推荐的二次分析方法。方法:该试验随机选择n = 880名焦虑和/或抑郁的大学生进行网络引导认知行为治疗(i-CBT)或常规治疗(TAU),并评估关节缓解情况。先前报道的分析证明了i-CBT的优势,但显著的HTE。在这里报道的再分析中,我们使用基线(即预随机化)协变量来预测随机分配到指导i-CBT的参与者的依从性,在两个干预组中基于该模型生成交叉验证的个人预期依从性评分,然后使用该预期综合评分作为扩展HTE分析的预测因子。结果:显著的干预效果仅限于期望依从性高的参与者。残余HTE无统计学意义。结论:未来的心理治疗HTE试验应常规开发并纳入预期依从性综合评分,以区分不同治疗依从性的影响和不同治疗有效性的影响。
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引用次数: 0
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International Journal of Methods in Psychiatric Research
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