Evidence map›Paper›PMID 31886433›Full record

ArticleContemporary clinical trials communications2020

Simulation-based power and sample size calculation for designing interrupted time series analyses of count outcomes in evaluation of health policy interventions.

Wei Liu, Shangyuan Ye, Bruce A Barton, Melissa A Fischer, Colleen Lawrence, Elizabeth J Rahn, Maria I Danila, Kenneth G Saag, Paul A Harris, Stephenie C Lemon and 2 more

Abstract read
In one paragraph

Article in Contemporary clinical trials communications, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed.

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  13. Environmental Factors and Hyperacute Stroke Care Activity During the COVID-19 Pandemic: An Interrupted Time-Series Analysis.Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association · 2020
    Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Wei LiuSchool of Management, Harbin Institute of Technology, Harbin, Heilongjiang 150001, China.
Shangyuan YeDepartment of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, 02115, USA.
Bruce A BartonSchool of Management, Harbin Institute of Technology, Harbin, Heilongjiang 150001, China.
Melissa A FischerDepartment of Internal Medicine, University of Massachusetts Medical School, Worcester, MA, 01605, USA.
Colleen LawrenceVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.
Elizabeth J RahnDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, 35294, USA.
Maria I DanilaDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, 35294, USA.
Kenneth G SaagDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, 35294, USA.
Paul A HarrisDepartment of Biomedical Informatics and Department of Biomedical Engineering, Vanderbilt University, Nashville, TN, 37203, USA.
Stephenie C LemonSchool of Management, Harbin Institute of Technology, Harbin, Heilongjiang 150001, China.
Jeroan J AllisonSchool of Management, Harbin Institute of Technology, Harbin, Heilongjiang 150001, China.
Bo ZhangDepartment of Neurology and ICCTR Biostatistics and Research Design Center, Boston Children's Hospital and Harvard Medical School, Boston, MA, 02215, USA.

Funding

University of Massachusetts Center for Clinical Science and Translational SupplementUL1TR001453 · NCATS · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI LUZURIAGA, KATHERINE F · 2015 to 2024
$39.0M
Strengthening Translational Research in Diverse Enrollment (STRIDE)U01TR001812 · NCATS · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI ALLISON, JEROAN J, HARRIS, PAUL A. · 2016 to 2020
$5.0M
NCATS NIH HHS U01 TR001812NCATS NIH HHS UL1 TR001453
6 · The paper itself

Abstract

objectiveThe purpose of this study was to present the design, model, and data analysis of an interrupted time series (ITS) model applied to evaluate the impact of health policy, systems, or environmental interventions using count outcomes. Simulation methods were used to conduct power and sample size calculations for these studies.

methodsWe proposed the models and analyses of ITS designs for count outcomes using the Strengthening Translational Research in Diverse Enrollment (STRIDE) study as an example. The models we used were observation-driven models, which bundle a lagged term on the conditional mean of the outcome for a time series of count outcomes.

resultsA simulation-based approach with ready-to-use computer programs was developed to calculate the sample size and power of two types of ITS models, Poisson and negative binomial, for count outcomes. Simulations were conducted to estimate the power of segmented autoregressive (AR) error models when autocorrelation ranged from -0.9 to 0.9, with various effect sizes. The power to detect the same magnitude of parameters varied largely, depending on the testing level change, the trend change, or both. The relationships between power and sample size and the values of the parameters were different between the two models.

conclusionThis article provides a convenient tool to allow investigators to generate sample sizes that will ensure sufficient statistical power when the ITS study design of count outcomes is implemented.

Indexed as

Count outcomesInterrupted time seriesPolicy evaluationPowerQuasi-experimental designSample size calculationSegmented regression

Identifiers

PMID31886433
PMCPMC6920506

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.