Annals of Epidemiology最新文献_第2页

Ischemic heart disease among South Asians with ischaemic stroke in three countries across two continents: the BRAINS study

IF 3.3 3区医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Annals of Epidemiology

Pub Date : 2025-02-19 DOI: 10.1016/j.annepidem.2025.02.006

Gie Ken-Dror , Prianka Sureshkumar , Thang S. Han , Sapna D Sharma , Padmavathy N. Sylaja , Fahmi Yousef Khan , Kameshwar Prasad , Pankaj Sharma

Background

Ischaemic heart disease (IHD) and cardiometabolic risk factors have been extensively investigated in those of European descent, yet they are more common among South Asians who make up around 20% of the world’s population. We explored the differences in IHD and cumulative metabolic profile in South Asians with stroke living in the UK, India and Qatar, compared with white British stroke patients.

Methods

The study included first-ever ischemic stroke white British patients and South Asians living in UK, India and Qatar from the ongoing large Bio-Repository of DNA in Stroke (BRAINS) international hospital-based stroke study.

Results

We analysed 4359 patients of which 1575 were white British (WB) UK residents, 1135 British South Asians (BSA), 1084 South Asians in India (ISA), and 565 South Asians in Qatar (QSA). Stroke patients from BSA and ISA background had a 9.5% (95%CI: 6.2-12.9, P<0.001) and 15.8% (95%CI: 13.1–28.9, P<0.001) higher prevalence of IHD respectively, compared to WB patients. Adjusting for traditional stroke risk factors, BSA patients continued to display an increased association of IHD compared to WB patients: OR=1.59 (95%CI: 1.25–2.02, P<0.001). Among South Asian ethnicity, compared to ISA, BSA had an almost twice the association of IHD: OR=1.83 (95%CI: 1.37-2.45, P<0.001). The OR for the presence of 2, or ≥3 cumulative cardiometabolic risk factors was 2.55 (95%CI: 2.02–3.23, P<0.001), and 3.86 (95%CI: 3.02–4.95, P<0.001) for South Asians (ISA, BSA, QSA) compared to WB patients, respectively.

Conclusion

South Asian ischaemic stroke immigrants have a higher prevalence of IHD as well as more cumulative cardiometabolic risk factors compared to those who remain on the subcontinent. Countries with large immigrant South Asian populations should focus public health campaigns to mitigate their high cardiometabolic risk profiles.

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引用次数: 0

Prevalence of traumatic brain injury among adults and children

IF 3.3 3区医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Annals of Epidemiology

Pub Date : 2025-02-17 DOI: 10.1016/j.annepidem.2025.02.005

Dana Waltzman PhD , Lindsey I. Black MPH , Jill Daugherty PhD , Alexis B. Peterson PhD , Benjamin Zablotsky PhD

Purpose

Surveillance of traumatic brain injury (TBI) in the United States has historically relied on healthcare administrative datasets, but these sources likely underestimate the true burden of TBI. Surveys that ask individuals to self- or proxy-report their experiences with their injuries are an alternative source for surveillance. This paper provides results from a large national survey that ascertained TBI among sampled adults and children.

Methods

Data from the 2023 National Health Interview Survey, a nationally representative household survey of the civilian non-institutionalized US population, were examined. Descriptive and bivariate statistics of demographic and injury characteristics of children and adults who sustained a TBI in the past 12 months were calculated.

Results

Analyses reveal that 3.0 % (n = 9757,000) of Americans (3.3 % of adults and 2.2 % of children (aged ≤17 years)) reported a TBI in the past year. Among children who sustained a TBI in the past year, over half (55.5 %) sustained their TBI during a sport or recreational activity, and 62.4 % were evaluated by a medical professional. The prevalence of TBI and injury characteristics varied by select demographics.

Conclusion

These findings demonstrate that TBI affects a large number of Americans and highlight the value of TBI surveillance through nationally representative surveys, providing a broad picture of prevalence, healthcare utilization, and setting of injury.

{"title":"Prevalence of traumatic brain injury among adults and children","authors":"Dana Waltzman PhD , Lindsey I. Black MPH , Jill Daugherty PhD , Alexis B. Peterson PhD , Benjamin Zablotsky PhD","doi":"10.1016/j.annepidem.2025.02.005","DOIUrl":"10.1016/j.annepidem.2025.02.005","url":null,"abstract":"<div><h3>Purpose</h3><div>Surveillance of traumatic brain injury (TBI) in the United States has historically relied on healthcare administrative datasets, but these sources likely underestimate the true burden of TBI. Surveys that ask individuals to self- or proxy-report their experiences with their injuries are an alternative source for surveillance. This paper provides results from a large national survey that ascertained TBI among sampled adults and children.</div></div><div><h3>Methods</h3><div>Data from the 2023 National Health Interview Survey, a nationally representative household survey of the civilian non-institutionalized US population, were examined. Descriptive and bivariate statistics of demographic and injury characteristics of children and adults who sustained a TBI in the past 12 months were calculated.</div></div><div><h3>Results</h3><div>Analyses reveal that 3.0 % (n = 9757,000) of Americans (3.3 % of adults and 2.2 % of children (aged ≤17 years)) reported a TBI in the past year. Among children who sustained a TBI in the past year, over half (55.5 %) sustained their TBI during a sport or recreational activity, and 62.4 % were evaluated by a medical professional. The prevalence of TBI and injury characteristics varied by select demographics.</div></div><div><h3>Conclusion</h3><div>These findings demonstrate that TBI affects a large number of Americans and highlight the value of TBI surveillance through nationally representative surveys, providing a broad picture of prevalence, healthcare utilization, and setting of injury.</div></div>","PeriodicalId":50767,"journal":{"name":"Annals of Epidemiology","volume":"103 ","pages":"Pages 40-47"},"PeriodicalIF":3.3,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143445502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Cancer and Chronic Disease Comorbidity in Incarcerated Individuals in the United States, Survey of Prison Inmates 2016.

IF 3.3 3区医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Annals of Epidemiology

Pub Date : 2025-02-11 DOI: 10.1016/j.annepidem.2025.02.002

Alyssa Watson, Mary Beth Terry

Purpose: There are limited studies examining the cancer and chronic disease comorbidity in individuals who are incarcerated in the United States.

Methods: We used the weighted analysis of 20,064 individuals from the 2016 Survey of Prison Inmates in state correctional facilities across 50 states, to examine cancers and other reported comorbid chronic conditions or diseases.

Results: 45% of 20,064 individuals reported living with at least one chronic disease. The proportion of individuals currently having cancer was 1.23% while 4.82% reported ever being diagnosed with cancer by a medical professional. Incarcerated individuals with any chronic condition or diseases reported a higher risk of currently having cancer after adjusting for smoking, time incarcerated and age (OR, 2.18; 95% CI, 1.43-3.31) compared to individuals not reporting having any chronic diseases. Conclusions There is a high burden of chronic diseases in individuals who are incarcerated, and these common chronic conditions are associated with currently having cancer even after adjusting for key risk factors for cancer like prior smoking and age. Efforts to reduce the high prevalence of chronic disease and improve cancer screening policies are necessary to improve the health of individuals who are incarcerated.

{"title":"Cancer and Chronic Disease Comorbidity in Incarcerated Individuals in the United States, Survey of Prison Inmates 2016.","authors":"Alyssa Watson, Mary Beth Terry","doi":"10.1016/j.annepidem.2025.02.002","DOIUrl":"https://doi.org/10.1016/j.annepidem.2025.02.002","url":null,"abstract":"<p><strong>Purpose: </strong>There are limited studies examining the cancer and chronic disease comorbidity in individuals who are incarcerated in the United States.</p><p><strong>Methods: </strong>We used the weighted analysis of 20,064 individuals from the 2016 Survey of Prison Inmates in state correctional facilities across 50 states, to examine cancers and other reported comorbid chronic conditions or diseases.</p><p><strong>Results: </strong>45% of 20,064 individuals reported living with at least one chronic disease. The proportion of individuals currently having cancer was 1.23% while 4.82% reported ever being diagnosed with cancer by a medical professional. Incarcerated individuals with any chronic condition or diseases reported a higher risk of currently having cancer after adjusting for smoking, time incarcerated and age (OR, 2.18; 95% CI, 1.43-3.31) compared to individuals not reporting having any chronic diseases. Conclusions There is a high burden of chronic diseases in individuals who are incarcerated, and these common chronic conditions are associated with currently having cancer even after adjusting for key risk factors for cancer like prior smoking and age. Efforts to reduce the high prevalence of chronic disease and improve cancer screening policies are necessary to improve the health of individuals who are incarcerated.</p>","PeriodicalId":50767,"journal":{"name":"Annals of Epidemiology","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143416003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Higher prevalence of long COVID observed in cancer survivors: Insights from a US nationwide survey

IF 3.3 3区医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Annals of Epidemiology

Pub Date : 2025-02-11 DOI: 10.1016/j.annepidem.2025.02.004

Lingchen Wang, Wei Yang Ph.D., M.D.

Background

Cancer and cancer treatments can weaken the body's immune system, making cancer patients particularly vulnerable to COVID-19. While evidence suggests that cancer patients may be at increased risk for severe outcomes after COVID-19 infection, there is a lack of population-based studies comparing long COVID prevalence between cancer survivors and non-cancer individuals.

Methods

We utilized data from the 2022 Behavioral Risk Factor Surveillance System (BRFSS), analyzing a sample of 120,658 U.S. adults who had tested positive for COVID-19. Long COVID was defined as the presence of COVID-19 symptoms lasting three months or longer. The weighted prevalence of long COVID was compared between cancer survivors and non-cancer individuals. Crude and adjusted odds ratios (ORs) with 95 % confidence intervals (CIs) were calculated. Multiple imputation was employed to address missing data on COVID-19 vaccination.

Results

Among 17,362 cancer survivors who tested positive for COVID-19, 4009 reported having long COVID (weighted prevalence = 24.0 %), compared to a weighted prevalence of 21.6 % in non-cancer individuals (p < 0.001). After controlling for covariates and accounting for the complex sampling design, the adjusted OR was 1.17 (95 % CI = 1.06–1.30, p = 0.002). In participants under 45 years old, cancer survivors had a notably higher prevalence of long COVID compared to non-cancer individuals (32.1 % vs. 21.3 %, p < 0.001), with an adjusted OR of 1.33 (95 % CI = 1.07–1.66, p = 0.012). In participants aged 45 and above, the prevalence difference was not significant (22.7 % vs. 21.9 %, p = 0.324), with an adjusted OR of 1.14 (95 % CI = 1.02–1.27, p = 0.024). Regarding the association of COVID-19 vaccination with long COVID, four or more doses were linked to a significant reduced odds of long COVID among cancer survivors (adjusted OR=0.55, 95 %CI = 0.34–0.88, p = 0.013).

Conclusions

Cancer survivors are observed to have higher odds of developing long COVID, particularly younger survivors. The association of COVID-19 vaccination with long COVID varies between cancer survivors and non-cancer individuals, with cancer survivors requiring more doses to achieve significant reduction in the odds of long COVID.

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引用次数: 0

Youden index and Tjur’s R2 in 2 × 2 tables

IF 3.3 3区医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Annals of Epidemiology

Pub Date : 2025-02-10 DOI: 10.1016/j.annepidem.2025.01.012

Linard Hoessly

We refer to a recent paper by Hughes and show that despite similarities in the rough form between Tjurs

R^{2}

coefficient of discrimination and Youden index for assessing diagnostic test performance on

2 \times 2

contingency tables, the two functions are different.

引用次数: 0

Adverse childhood experiences and firearm storage patterns

IF 3.3 3区医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Annals of Epidemiology

Pub Date : 2025-02-06 DOI: 10.1016/j.annepidem.2025.02.001

Alexander Testa , Karyn Fu , Dylan B. Jackson , Daniel C. Semenza , Sandra McKay

This study investigates the relationship between adverse childhood experiences (ACEs) and firearm storage practices among adults in firearm-owning households using data from the 2023 Behavioral Risk Factor Surveillance System (BRFSS) across Nevada, New Jersey, Oregon, and Virginia. Findings from multiple logistic regression analyses reveal that relative to respondents with 0 ACEs, 2–3 ACEs (Adjusted Odds Ratio [aOR] = 1.48, 95 % Confidence Interval [CI] = 1.12–1.97, p = .007) and 4 + ACEs (aOR = 1.60, 95 % CI = 1.19–2.16, p = .002) were associated with a higher likelihood of storing a firearm loaded versus unloaded. Among individual ACE items, household alcoholism (aOR = 1.36, 95 % CI = 1.08–1.71, p = .008), household incarceration (aOR = 1.67, 95 % CI = 1.18–2.36, p = .004), parental divorce/separation (aOR = 1.37, 95 % CI = 1.09–1.72, p = .007) were associated with higher odds of storing a firearm loaded. These findings underscore the need for tailored public health interventions that address the lasting impacts of childhood adversity on health and safety practices in adulthood.

{"title":"Adverse childhood experiences and firearm storage patterns","authors":"Alexander Testa , Karyn Fu , Dylan B. Jackson , Daniel C. Semenza , Sandra McKay","doi":"10.1016/j.annepidem.2025.02.001","DOIUrl":"10.1016/j.annepidem.2025.02.001","url":null,"abstract":"<div><div>This study investigates the relationship between adverse childhood experiences (ACEs) and firearm storage practices among adults in firearm-owning households using data from the 2023 Behavioral Risk Factor Surveillance System (BRFSS) across Nevada, New Jersey, Oregon, and Virginia. Findings from multiple logistic regression analyses reveal that relative to respondents with 0 ACEs, 2–3 ACEs (Adjusted Odds Ratio [aOR] = 1.48, 95 % Confidence Interval [CI] = 1.12–1.97, <em>p</em> = .007) and 4 + ACEs (aOR = 1.60, 95 % CI = 1.19–2.16, <em>p</em> = .002) were associated with a higher likelihood of storing a firearm loaded versus unloaded. Among individual ACE items, household alcoholism (aOR = 1.36, 95 % CI = 1.08–1.71, <em>p</em> = .008), household incarceration (aOR = 1.67, 95 % CI = 1.18–2.36, <em>p</em> = .004), parental divorce/separation (aOR = 1.37, 95 % CI = 1.09–1.72, <em>p</em> = .007) were associated with higher odds of storing a firearm loaded. These findings underscore the need for tailored public health interventions that address the lasting impacts of childhood adversity on health and safety practices in adulthood.</div></div>","PeriodicalId":50767,"journal":{"name":"Annals of Epidemiology","volume":"103 ","pages":"Pages 16-20"},"PeriodicalIF":3.3,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143350718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

COVID-19 vaccine acceptance differences among unvaccinated foreign- and united states-born persons: A cross-sectional study, 2021

IF 3.3 3区医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Annals of Epidemiology

Pub Date : 2025-02-06 DOI: 10.1016/j.annepidem.2025.01.009

Aryana Sepassi PharmD, MAS , Samantha Garcia PhD, MPH, CHES , Sora Tanjasiri DrPH , Sunmin Lee ScD , Nana Entsuah-Boateng PharmD , Mark Bounthavong PharmD, PhD, MPH

Purpose

To investigate the association between nativity and COVID-19 vaccine acceptance and its interaction with race/ethnicity, education, and English proficiency.

Methods

Differences in vaccine acceptance among propensity-score matched foreign- and US-born persons using 2021 California Health Interview Survey Data were measured using a survey-weighted multivariable logistic regression model with interaction terms and average predicted probabilities between nativity and: race/ethnicity, education, English proficiency.

Results

A total of 4,234,655 survey-weighted persons (8504 unweighted) met inclusion criteria; 2251,279 (53 %) were foreign-born (1,983,376 US-born), and 55 % of all persons were Hispanic/Latino, 22 % were Non-Hispanic White, 17 % were Non-Hispanic Asian/Pacific Islander, 3.6 % were Non-Hispanic Black/African American, and 2.5 % were categorized as ‘Other’. Foreign-born status was significantly associated with greater odds of acceptance (adjusted odds ratio [aOR], 2.81 [95 %CI, 1.16–6.83]). Foreign-born Hispanic persons had a significantly greater probability of acceptance compared to their US-born counterparts (average probability difference, +0.11 [95 %CI, +0.023, +0.20]). Foreign-born persons with poor English proficiency had a lower probability of acceptance versus US-born persons (APD, −0.081, [95 %CI, −0.43, 0.27]).

Conclusions

Nativity was significantly associated with COVID-19 vaccine acceptance, and this relationship varied by race/ethnicity and English proficiency. These findings may be used to direct future interventions aimed at improving COVID-19 vaccination rates.

{"title":"COVID-19 vaccine acceptance differences among unvaccinated foreign- and united states-born persons: A cross-sectional study, 2021","authors":"Aryana Sepassi PharmD, MAS , Samantha Garcia PhD, MPH, CHES , Sora Tanjasiri DrPH , Sunmin Lee ScD , Nana Entsuah-Boateng PharmD , Mark Bounthavong PharmD, PhD, MPH","doi":"10.1016/j.annepidem.2025.01.009","DOIUrl":"10.1016/j.annepidem.2025.01.009","url":null,"abstract":"<div><h3>Purpose</h3><div>To investigate the association between nativity and COVID-19 vaccine acceptance and its interaction with race/ethnicity, education, and English proficiency.</div></div><div><h3>Methods</h3><div>Differences in vaccine acceptance among propensity-score matched foreign- and US-born persons using 2021 California Health Interview Survey Data were measured using a survey-weighted multivariable logistic regression model with interaction terms and average predicted probabilities between nativity and: race/ethnicity, education, English proficiency.</div></div><div><h3>Results</h3><div>A total of 4,234,655 survey-weighted persons (8504 unweighted) met inclusion criteria; 2251,279 (53 %) were foreign-born (1,983,376 US-born), and 55 % of all persons were Hispanic/Latino, 22 % were Non-Hispanic White, 17 % were Non-Hispanic Asian/Pacific Islander, 3.6 % were Non-Hispanic Black/African American, and 2.5 % were categorized as ‘Other’. Foreign-born status was significantly associated with greater odds of acceptance (adjusted odds ratio [aOR], 2.81 [95 %CI, 1.16–6.83]). Foreign-born Hispanic persons had a significantly greater probability of acceptance compared to their US-born counterparts (average probability difference, +0.11 [95 %CI, +0.023, +0.20]). Foreign-born persons with poor English proficiency had a lower probability of acceptance versus US-born persons (APD, −0.081, [95 %CI, −0.43, 0.27]).</div></div><div><h3>Conclusions</h3><div>Nativity was significantly associated with COVID-19 vaccine acceptance, and this relationship varied by race/ethnicity and English proficiency. These findings may be used to direct future interventions aimed at improving COVID-19 vaccination rates.</div></div>","PeriodicalId":50767,"journal":{"name":"Annals of Epidemiology","volume":"103 ","pages":"Pages 21-27"},"PeriodicalIF":3.3,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143373104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Prevalence estimates of mental illness among parents in the United States: Results from the National Survey on Drug Use and Health, 2021–2023

IF 3.3 3区医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Annals of Epidemiology

Pub Date : 2025-02-01 DOI: 10.1016/j.annepidem.2025.01.007

Paul J. Geiger , Lauren Klein Warren , Leyla Stambaugh , Douglas Richesson , Tenecia Smith , Jennifer Hoenig

引用次数: 0

Statistical harmonization of versions of measures across studies using external data: Self-rated health and self-rated memory 使用外部数据的跨研究测量版本的统计统一：自评健康和自评记忆。

IF 3.3 3区医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Annals of Epidemiology

Pub Date : 2025-02-01 DOI: 10.1016/j.annepidem.2025.01.002

Yingyan Wu MS , Eleanor Hayes-Larson PhD, MPH , Yixuan Zhou , Vincent Bouteloup PharmD , Scott C. Zimmerman MPH , Anna M. Pederson MPH , Vincent Planche MD, PhD , Marissa J. Seamans PhD, MSPH , Daniel Westreich PhD , M. Maria Glymour , Laura E. Gibbons PhD , Carole Dufouil PhD , Elizabeth Rose Mayeda PhD, MPH

Purpose

Harmonizing variables for constructs measured differently across studies is essential for comparing, combining, and generalizing results. We developed and fielded a brief survey to harmonize Likert and continuous versions of measures for two constructs, self-rated health and self-rated memory, for use in studies of French older adults.

Methods

We recruited 300 participants from a French memory clinic in 2023 to answer both the Likert and continuous versions of self-rated health and self-rated memory questions. For each construct, we predicted responses to the Likert version with multinomial and ordinal logistic models, varying specifications of continuous version responses (linear or spline) and covariate sets (question order, age, sex/gender, and interactions between the continuous version and covariates). We also implemented a percentiles-based crosswalk sensitivity analysis. We compared Cohen’s weighted kappa values to identify the best statistical harmonization approach.

Results

In the final models [multinomial models with continuous version spline, question order (self-rated memory model only), age, sex/gender, and interactions between the continuous version and covariates], weighted kappa values were 0.61 for self-rated health and 0.60 for self-rated memory, reflecting moderate agreement.

Conclusions

Primary data collection feasibly facilitates statistical harmonization of variables for constructs measured differently across studies.

目的：协调不同研究中不同测量结构的变量对于比较、组合和概括结果是必不可少的。我们开发并进行了一项简短的调查，以协调李克特和连续版本的两个构式测量，自评健康和自评记忆，用于法国老年人的研究。方法：我们于2023年从法国一家记忆诊所招募了300名参与者，回答了李克特和连续版本的自评健康和自评记忆问题。对于每个结构，我们使用多项和有序逻辑模型、不同规格的连续版本反应（线性或样条）和协变量集（问题顺序、年龄、性别/性别以及连续版本和协变量之间的相互作用）预测对李克特版本的反应。我们还实施了基于百分位数的人行横道敏感性分析。我们比较了Cohen的加权kappa值，以确定最佳的统计协调方法。结果：在最终模型[具有连续版本样条、问题顺序（仅自评记忆模型）、年龄、性别/性别和连续版本与协变量之间相互作用的多项模型]中，自评健康的加权kappa值为0.61，自评记忆的加权kappa值为0.60，反映出中度一致性。结论：原始数据收集可行地促进了在不同研究中测量不同结构的变量的统计协调。

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引用次数: 0

Conceptualizing patient-level adverse effects in implementation trials 概念化实施试验中患者层面的不良反应。

IF 3.3 3区医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Annals of Epidemiology

Pub Date : 2025-02-01 DOI: 10.1016/j.annepidem.2024.12.012

Charles W. Goss , Lindsey M. Filiatreau , Lisa R. Hirschhorn , Mark D. Huffman , Aaloke Mody , Byron J. Powell , Emmanuel Tetteh , Elvin H. Geng , Mosepele Mosepele

Background

Identifying and monitoring adverse effects (AEs) are integral to ensuring patient safety in clinical trials. Research sponsors and regulatory bodies have put into place a variety of policies and procedures to guide researchers in protecting patient safety during clinical trials. However, it remains unclear how these policies and procedures should be adapted for trials in implementation science. As a starting point, we develop a conceptual model that traces causal pathways leading from implementation strategies to AEs, propose a definition and classification of such effects, and provide recommendations for monitoring and oversight.

Main text

We propose four major types of adverse effects for implementation trials. First, we characterize implementation strategies that lead to “proper use” of an intervention that align with AEs as conceptualized and reported in clinical trials. Second, we characterize a strategy’s AEs mediated through “misuse” which involves inappropriate utilization of an evidence-based intervention (EBI). Third, we characterize a strategy which focuses on one EBI and may inadvertently cause the inappropriate discontinuation or “disuse” of other EBIs already in place, thus inducing AEs. Finally, we characterize strategies that may cause AEs by reducing the use of an EBI in the target population (i.e., “nonuse”). Based on these considerations, we propose an extended definition of adverse effects that includes harms that are causally related to implementation strategies, termed Implementation strategy Adverse Effects (IAEs). We recommend researchers, oversight committees, sponsors, and other stakeholders work together prior to trials to determine the best approaches for identifying, monitoring, and reporting IAEs.

Conclusions

In this paper, we develop a conceptual model to identify four types of AEs in implementation trials clarifying the mechanisms linking implementation strategies to patterns of use of the EBI and potential patient-level harms. We propose a new definition that links implementation strategies to AEs that can be used to guide conceptualization, monitoring, and oversight of potential harms in future implementation trials. Our work represents an important step towards understanding adverse effects in implementation trials and lays the groundwork for future advancement in the conceptualization of other types of adverse effects (e.g., harms to providers) encountered in implementation trials.

背景：识别和监测不良反应（ae）是确保临床试验患者安全不可或缺的一部分。研究发起人和监管机构已经制定了各种政策和程序，以指导研究人员在临床试验期间保护患者安全。然而，目前尚不清楚这些政策和程序应如何适应实施科学的试验。作为起点，我们开发了一个概念模型，该模型追溯了从实施战略到ae的因果路径，提出了此类影响的定义和分类，并为监测和监督提供了建议。我们提出了实施试验的四种主要不利影响类型。首先，我们描述了导致“正确使用”干预措施的实施策略，这些干预措施与临床试验中概念化和报告的ae一致。其次，我们描述了通过“误用”介导的策略ae的特征，误用涉及不适当地使用循证干预（EBI）。第三，我们描述了一种专注于一个EBI的策略，可能无意中导致其他EBI的不当终止或“废弃”，从而诱发ae。最后，我们描述了可能通过减少目标人群中EBI的使用（即“不使用”）来导致ae的策略。基于这些考虑，我们提出了一个扩展的不利影响的定义，包括与实施策略有因果关系的危害，称为实施策略不利影响（iae）。我们建议研究人员、监督委员会、赞助方和其他利益攸关方在试验前共同努力，确定识别、监测和报告iae的最佳方法。在本文中，我们建立了一个概念模型来识别实施试验中的四种类型的ae，阐明了将实施策略与EBI使用模式和潜在患者层面危害联系起来的机制。我们提出了一个新的定义，将实施策略与ae联系起来，用于指导未来实施试验中潜在危害的概念化、监测和监督。我们的工作代表了理解实施试验中不利影响的重要一步，并为未来进一步概念化实施试验中遇到的其他类型的不利影响（例如，对提供者的伤害）奠定了基础。

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引用次数: 0