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Article ; Online: Using Effect Scores to Characterize Heterogeneity of Treatment Effects.

Wang, Guanbo / Heagerty, Patrick J / Dahabreh, Issa J

2024 Volume 331, Issue 14, Page(s) 1225–1226

MeSH term(s)	Humans ; Critical Illness/therapy ; Oximetry ; Oxygen/analysis ; Treatment Effect Heterogeneity ; Patient Acuity ; Randomized Controlled Trials as Topic ; Models, Statistical
Chemical Substances	Oxygen (S88TT14065)
Language	English
Publishing date	2024-03-18
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Comment
ZDB-ID	2958-0
ISSN	1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
ISSN (online)	1538-3598
ISSN	0254-9077 ; 0002-9955 ; 0098-7484
DOI	10.1001/jama.2024.3376
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Article ; Online: Description and initial validation of a novel measure of pain intensity: the Numeric Rating Scale of Underlying Pain without concurrent Analgesic use.

Suri, Pradeep / Heagerty, Patrick J / Timmons, Andrew / Jensen, Mark P

Pain

2024

Abstract: Abstract: Although many individuals with chronic pain use analgesics, the methods used in many randomized controlled trials (RCTs) do not sufficiently account for confounding by differential post-randomization analgesic use. This may lead to ... ...

Abstract	Abstract: Although many individuals with chronic pain use analgesics, the methods used in many randomized controlled trials (RCTs) do not sufficiently account for confounding by differential post-randomization analgesic use. This may lead to underestimation of average treatment effects and diminished power. We introduce (1) a new measure-the Numeric Rating Scale of Underlying Pain without concurrent Analgesic use (NRS-UP(A))-which can shift the estimand of interest in an RCT to target effects of a treatment on pain intensity in the hypothetical situation where analgesic use was not occurring at the time of outcome assessment; and (2) a new pain construct-an individuals' perceived effect of analgesic use on pain intensity (EA). The NRS-UP(A) may be used as a secondary outcome in RCTs of point treatments or nonpharmacologic treatments. Among 662 adults with back pain in primary care, participants' mean value of the NRS-UP(A) among those using analgesics was 1.2 NRS points higher than their value on the conventional pain intensity NRS, reflecting a mean EA value of -1.2 NRS points and a perceived beneficial effect of analgesics. More negative values of EA (ie, greater perceived benefit) were associated with a greater number of analgesics used but not with pain intensity, analgesic type, or opioid dose. The NRS-UP(A) and EA were significantly associated with future analgesic use 6 months later, but the conventional pain NRS was not. Future research is needed to determine whether the NRS-UP(A), used as a secondary outcome may allow pain RCTs to target alternative estimands with clinical relevance.
Language	English
Publishing date	2024-01-02
Publishing country	United States
Document type	Journal Article
ZDB-ID	193153-2
ISSN	1872-6623 ; 0304-3959
ISSN (online)	1872-6623
ISSN	0304-3959
DOI	10.1097/j.pain.0000000000003150
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Article ; Online: Correction: Sample Size Calculations for Stepped Wedge Designs with Treatment Effects that May Change with the Duration of Time under Intervention.

Hughes, James P / Lee, Wen-Yu / Troxel, Andrea B / Heagerty, Patrick J

Prevention science : the official journal of the Society for Prevention Research

2024

Language	English
Publishing date	2024-01-06
Publishing country	United States
Document type	Published Erratum
ZDB-ID	2251270-6
ISSN	1573-6695 ; 1389-4986
ISSN (online)	1573-6695
ISSN	1389-4986
DOI	10.1007/s11121-024-01645-2
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Article ; Online: Correction: Sample Size Calculations for Stepped Wedge Designs with Treatment Effects that May Change with the Duration of Time under Intervention.

Hughes, James P / Lee, Wen-Yu / Troxel, Andrea B / Heagerty, Patrick J

Prevention science : the official journal of the Society for Prevention Research

2024

Language	English
Publishing date	2024-02-16
Publishing country	United States
Document type	Published Erratum
ZDB-ID	2251270-6
ISSN	1573-6695 ; 1389-4986
ISSN (online)	1573-6695
ISSN	1389-4986
DOI	10.1007/s11121-024-01652-3
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Article ; Online: Sample Size Calculations for Stepped Wedge Designs with Treatment Effects that May Change with the Duration of Time under Intervention.

Hughes, James P / Lee, Wen-Yu / Troxel, Andrea B / Heagerty, Patrick J

Prevention science : the official journal of the Society for Prevention Research

2023

Abstract: The stepped wedge design is often used to evaluate interventions as they are rolled out across schools, health clinics, communities, or other clusters. Most models used in the design and analysis of stepped wedge trials assume that the intervention ... ...

Abstract	The stepped wedge design is often used to evaluate interventions as they are rolled out across schools, health clinics, communities, or other clusters. Most models used in the design and analysis of stepped wedge trials assume that the intervention effect is immediate and constant over time following implementation of the intervention (the "exposure time"). This is known as the IT (immediate treatment effect) assumption. However, recent research has shown that using methods based on the IT assumption when the treatment effect varies over exposure time can give extremely misleading results. In this manuscript, we discuss the need to carefully specify an appropriate measure of the treatment effect when the IT assumption is violated and we show how a stepped wedge trial can be powered when it is anticipated that the treatment effect will vary as a function of the exposure time. Specifically, we describe how to power a trial when the exposure time indicator (ETI) model of Kenny et al. (Statistics in Medicine, 41, 4311-4339, 2022) is used and the estimand of interest is a weighted average of the time-varying treatment effects. We apply these methods to the ADDRESS-BP trial, a type 3 hybrid implementation study designed to address racial disparities in health care by evaluating a practice-based implementation strategy to reduce hypertension in African American communities.
Language	English
Publishing date	2023-09-20
Publishing country	United States
Document type	Journal Article
ZDB-ID	2251270-6
ISSN	1573-6695 ; 1389-4986
ISSN (online)	1573-6695
ISSN	1389-4986
DOI	10.1007/s11121-023-01587-1
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Article ; Online: Analysis of multiple-period group randomized trials: random coefficients model or repeated measures ANOVA?

Moyer, Jonathan C / Heagerty, Patrick J / Murray, David M

Trials

2022 Volume 23, Issue 1, Page(s) 987

Abstract: Background: Multiple-period parallel group randomized trials (GRTs) analyzed with linear mixed models can represent time in mean models as continuous or categorical. If time is continuous, random effects are traditionally group- and member-level ... ...

Abstract	Background: Multiple-period parallel group randomized trials (GRTs) analyzed with linear mixed models can represent time in mean models as continuous or categorical. If time is continuous, random effects are traditionally group- and member-level deviations from condition-specific slopes and intercepts and are referred to as random coefficients (RC) analytic models. If time is categorical, random effects are traditionally group- and member-level deviations from time-specific condition means and are referred to as repeated measures ANOVA (RM-ANOVA) analytic models. Longstanding guidance recommends the use of RC over RM-ANOVA for parallel GRTs with more than two periods because RC exhibited nominal type I error rates for both time parameterizations while RM-ANOVA exhibited inflated type I error rates when applied to data generated using the RC model. However, this recommendation was developed assuming a variance components covariance matrix for the RM-ANOVA, using only cross-sectional data, and explicitly modeling time × group variation. Left unanswered were how well RM-ANOVA with an unstructured covariance would perform on data generated according to the RC mechanism, if similar patterns would be observed in cohort data, and the impact of not modeling time × group variation if such variation was present in the data-generating model. Methods: Continuous outcomes for cohort and cross-sectional parallel GRT data were simulated according to RM-ANOVA and RC mechanisms at five total time periods. All simulations assumed time × group variation. We varied the number of groups, group size, and intra-cluster correlation. Analytic models using RC, RM-ANOVA, RM-ANOVA with unstructured covariance, and a Saturated random effects structure were applied to the data. All analytic models specified time × group random effects. The analytic models were then reapplied without specifying random effects for time × group. Results: Results indicated the RC and saturated analytic models maintained the nominal type I error rate in all data sets, RM-ANOVA with an unstructured covariance did not avoid type I error rate inflation when applied to cohort RC data, and analytic models omitting time-varying group random effects when such variation exists in the data were prone to substantial type I error inflation unless the residual error variance is high relative to the time × group variance. Conclusion: The time × group RC and saturated analytic models are recommended as the default for multiple period parallel GRTs.
MeSH term(s)	Humans ; Cross-Sectional Studies ; Randomized Controlled Trials as Topic ; Research Design
Language	English
Publishing date	2022-12-07
Publishing country	England
Document type	Journal Article
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-022-06917-2
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Article ; Online: A comparison of landmark methods and time-dependent ROC methods to evaluate the time-varying performance of prognostic markers for survival outcomes.

Bansal, Aasthaa / Heagerty, Patrick J

Diagnostic and prognostic research

2019 Volume 3, Page(s) 14

Abstract: Background: Prognostic markers use an individual's characteristics at a given time to predict future disease events, with the ultimate goal of guiding medical decision-making. If an accurate prediction can be made, then a prognostic marker could be used ...

Abstract	Background: Prognostic markers use an individual's characteristics at a given time to predict future disease events, with the ultimate goal of guiding medical decision-making. If an accurate prediction can be made, then a prognostic marker could be used clinically to identify those subjects at greatest risk for future adverse events and may be used to define populations appropriate for targeted therapeutic intervention. Often, a marker is measured at a single baseline time point such as disease diagnosis, and then used to guide decisions at multiple subsequent time points. However, the performance of candidate markers may vary over time as an individual's underlying clinical status changes. Methods: We provide an overview and comparison of modern statistical methods for evaluating the time-varying accuracy of a baseline prognostic marker. We compare approaches that consider cumulative versus incident events. Additionally, we compare the common approach of using hazard ratios obtained from Cox proportional hazards regression to more recently developed approaches using time-dependent receiver operating characteristic (ROC) curves. The alternative statistical summaries are illustrated using a multiple myeloma study of candidate biomarkers. Results: We found that time-varying HRs, HR ( Conclusions: We compared alternative summaries for quantifying a prognostic marker's time-varying performance. Although landmark-based predictions may be useful when patient predictions are needed at select times, a focus on incident events naturally facilitates evaluating trends in performance over time.
Language	English
Publishing date	2019-07-25
Publishing country	England
Document type	Journal Article
ISSN	2397-7523
ISSN (online)	2397-7523
DOI	10.1186/s41512-019-0057-6
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Article ; Online: Platelet Transfusion and Death or Neurodevelopmental Impairment in Children Born Extremely Preterm.

Davenport, Patricia E / Wood, Thomas R / Heagerty, Patrick J / Sola-Visner, Martha C / Juul, Sandra E / Patel, Ravi M

JAMA network open

2024 Volume 7, Issue 1, Page(s) e2352394

Abstract: Importance: Infants born extremely preterm receive transfusions at higher platelet count thresholds than older children and adults due to concerns for intracranial hemorrhage. A recent randomized trial comparing 2 platelet transfusion thresholds showed ... ...

Abstract	Importance: Infants born extremely preterm receive transfusions at higher platelet count thresholds than older children and adults due to concerns for intracranial hemorrhage. A recent randomized trial comparing 2 platelet transfusion thresholds showed the higher threshold was associated with increased risk of long-term adverse neurodevelopmental outcomes. Objective: To evaluate the association of platelet transfusion exposure with death and severe neurodevelopmental impairment (NDI) at 2 years' corrected age in a cohort of infants born extremely preterm. Design, setting, and participants: An observational cohort study and secondary analysis of the Preterm Erythropoietin Neuroprotection Trial, a randomized, placebo-controlled clinical trial of erythropoietin neuroprotection in neonates born extremely preterm, was conducted in 30 neonatal intensive care units in the US from December 1, 2013, to September 31, 2016. This analysis included 819 infants born extremely preterm at 24 to 27 completed weeks of gestation who had a documented outcome (death or neurodevelopmental assessment). Analysis was performed in April 2023. Exposures: Any platelet transfusion during neonatal intensive care unit hospitalization. Main outcomes and measures: The primary composite outcome was death or severe NDI evaluated at 2 years' corrected age using the Bayley Scales of Infant Development-Third Edition (BSID-III) and the Gross Motor Function Classification System and was defined as the presence of severe cerebral palsy or a BSID-III composite motor or cognitive score 2 SDs below the mean. Confounding by indication for platelet transfusion was addressed with covariate adjustment and propensity score methods. Results: Of the 819 infants included in the analysis (429 [52.4%] male; mean [SD] gestational age, 25.5 [1.1] weeks), 245 (30.0%) received at least 1 platelet transfusion during their initial hospitalization. The primary outcome occurred in 46.5% (114 of 245) of infants exposed to a platelet transfusion and 13.9% (80 of 574) of nonexposed infants with a corresponding odds ratio of 2.43 (95% CI, 1.24-4.76), adjusted for propensity score, gestational age at birth, and trial treatment group. The individual components of death and severe NDI were directionally consistent with the overall composite outcome. Conclusions and relevance: The findings of this study suggest that platelet transfusion in infants born extremely preterm may be associated with an increased risk of death or severe NDI at 2 years' corrected age, although the possibility of residual confounding by indication cannot be excluded.
MeSH term(s)	Female ; Humans ; Infant, Newborn ; Male ; Cerebral Palsy ; Erythropoietin ; Gestational Age ; Infant, Extremely Premature ; Platelet Transfusion ; Randomized Controlled Trials as Topic
Chemical Substances	Erythropoietin (11096-26-7)
Language	English
Publishing date	2024-01-02
Publishing country	United States
Document type	Journal Article ; Observational Study
ISSN	2574-3805
ISSN (online)	2574-3805
DOI	10.1001/jamanetworkopen.2023.52394
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Article ; Online: Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis : A Randomized Clinical Trial.

Mehrotra, Rajnish / Cukor, Daniel / McCurry, Susan M / Rue, Tessa / Roumelioti, Maria-Eleni / Heagerty, Patrick J / Unruh, Mark

Annals of internal medicine

2024 Volume 177, Issue 2, Page(s) 177–188

Abstract: Background: Chronic insomnia is common in patients undergoing in-center hemodialysis, yet there is limited evidence on effective treatments for this population.: Objective: To compare the effectiveness of cognitive behavioral therapy for insomnia ( ... ...

Abstract	Background: Chronic insomnia is common in patients undergoing in-center hemodialysis, yet there is limited evidence on effective treatments for this population. Objective: To compare the effectiveness of cognitive behavioral therapy for insomnia (CBT-I), trazodone, and placebo for insomnia in patients undergoing long-term hemodialysis. Design: Randomized, multicenter, double-blinded, placebo-controlled trial. (ClinicalTrials.gov: NCT03534284). Setting: 26 dialysis units in Albuquerque, New Mexico, and Seattle, Washington. Participants: Patients with Insomnia Severity Index (ISI) score of 10 or greater, with sleep disturbances on 3 or more nights per week for 3 or more months. Intervention: Participants were randomly assigned to 6 weeks of CBT-I, trazodone, or placebo. Measurements: The primary outcome was the ISI score at 7 and 25 weeks from randomization. Results: A total of 923 patients were prescreened, and of the 411 patients with chronic insomnia, 126 were randomly assigned to CBT-I ( Limitation: Modest sample size and most participants had mild or moderate insomnia. Conclusion: In patients undergoing hemodialysis with mild or moderate chronic insomnia, there was no difference in the effectiveness of 6 weeks of CBT-I or trazodone compared with placebo. The incidence of SAEs was higher with trazodone. Primary funding source: National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases.
MeSH term(s)	Humans ; Sleep Initiation and Maintenance Disorders/drug therapy ; Trazodone/adverse effects ; Renal Dialysis/adverse effects ; Treatment Outcome ; Research Design
Chemical Substances	Trazodone (YBK48BXK30)
Language	English
Publishing date	2024-01-16
Publishing country	United States
Document type	Randomized Controlled Trial ; Multicenter Study ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	336-0
ISSN	1539-3704 ; 0003-4819
ISSN (online)	1539-3704
ISSN	0003-4819
DOI	10.7326/M23-1794
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Article ; Online: A general framework for developing computable clinical phenotype algorithms.

Carrell, David S / Floyd, James S / Gruber, Susan / Hazlehurst, Brian L / Heagerty, Patrick J / Nelson, Jennifer L / Williamson, Brian D / Ball, Robert

Journal of the American Medical Informatics Association : JAMIA

2024

Abstract: Objective: Present a general framework providing high-level guidance to developers of computable algorithms for identifying patients with specific clinical conditions (phenotypes) through a variety of approaches, including but not limited to machine ... ...

Abstract	Objective: Present a general framework providing high-level guidance to developers of computable algorithms for identifying patients with specific clinical conditions (phenotypes) through a variety of approaches, including but not limited to machine learning and natural language processing methods to incorporate rich electronic health record data. Materials/methods: Drawing on extensive prior phenotyping experiences and insights derived from three algorithm development projects conducted specifically for this purpose, our team with expertise in clinical medicine, statistics, informatics, pharmacoepidemiology, and healthcare data science methods conceptualized stages of development and corresponding sets of principles, strategies, and practical guidelines for improving the algorithm development process. Results: We propose five stages of algorithm development and corresponding principles, strategies, and guidelines: 1) assessing fitness-for-purpose, 2) creating gold standard data, 3) feature engineering, 4) model development, and 5) model evaluation. Discussion/conclusion: This framework is intended to provide practical guidance and serve as a basis for future elaboration and extension.
Language	English
Publishing date	2024-05-15
Publishing country	England
Document type	Journal Article
ZDB-ID	1205156-1
ISSN	1527-974X ; 1067-5027
ISSN (online)	1527-974X
ISSN	1067-5027
DOI	10.1093/jamia/ocae121
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