Validating an approach to overcome the immeasurable time bias in cohort studies: a real-world example and Monte Carlo simulation study.

Cohort designs immeasurable time bias methodology pharmacoepidemiology simulation study

Journal

International journal of epidemiology
ISSN: 1464-3685
Titre abrégé: Int J Epidemiol
Pays: England
ID NLM: 7802871

Informations de publication

Date de publication:
05 10 2023
Historique:
received: 21 06 2022
accepted: 18 04 2023
medline: 9 10 2023
pubmed: 12 5 2023
entrez: 12 5 2023
Statut: ppublish

Résumé

Immeasurable time bias arises from the lack of in-hospital medication information. It has been suggested that time-varying adjustment for hospitalization may minimize this potential bias. However, whereas we examined this issue in one case study, there remains a need to assess the validity of this approach in other settings. Using a Monte Carlo simulation, we generated synthetic immeasurable time-varying hospitalization-related factors of duration, frequency and timing. Nine scenarios were created by combining three frequency scenarios and three duration scenarios, where the empirical cohort distribution of hospitalization was used to simulate the 'timing'. We used Korea's healthcare database and a case example of β-blocker use and mortality among patients with heart failure. We estimated the gold-standard hazard ratio (HR) with 95% CI using inpatient and outpatient drug data, and that of the pseudo-outpatient setting using outpatient data only. We assessed the validity of adjusting for time-varying hospitalization in nine different scenarios, using relative bias, confidence limit ratio (CLR) and mean squared error (MSE) compared with the empirical gold-standard estimate across bootstrap resamples. With the real-world gold standard (HR 0.73; 95% CI 0.67-0.80) as the reference estimate, adjusting for time-varying hospitalization (0.71; 0.63-0.80) effectively reduced the immeasurable time bias and had the following performance metrics across the nine scenarios: relative bias (range: -7.08% to 0.61%), CLR (1.28 to 1.36) and MSE (0.0005 to 0.0031). The approach of adjusting for time-varying hospitalization consistently reduced the immeasurable time bias in Monte Carlo simulated data.

Sections du résumé

BACKGROUND
Immeasurable time bias arises from the lack of in-hospital medication information. It has been suggested that time-varying adjustment for hospitalization may minimize this potential bias. However, whereas we examined this issue in one case study, there remains a need to assess the validity of this approach in other settings.
METHODS
Using a Monte Carlo simulation, we generated synthetic immeasurable time-varying hospitalization-related factors of duration, frequency and timing. Nine scenarios were created by combining three frequency scenarios and three duration scenarios, where the empirical cohort distribution of hospitalization was used to simulate the 'timing'. We used Korea's healthcare database and a case example of β-blocker use and mortality among patients with heart failure. We estimated the gold-standard hazard ratio (HR) with 95% CI using inpatient and outpatient drug data, and that of the pseudo-outpatient setting using outpatient data only. We assessed the validity of adjusting for time-varying hospitalization in nine different scenarios, using relative bias, confidence limit ratio (CLR) and mean squared error (MSE) compared with the empirical gold-standard estimate across bootstrap resamples.
RESULTS
With the real-world gold standard (HR 0.73; 95% CI 0.67-0.80) as the reference estimate, adjusting for time-varying hospitalization (0.71; 0.63-0.80) effectively reduced the immeasurable time bias and had the following performance metrics across the nine scenarios: relative bias (range: -7.08% to 0.61%), CLR (1.28 to 1.36) and MSE (0.0005 to 0.0031).
CONCLUSIONS
The approach of adjusting for time-varying hospitalization consistently reduced the immeasurable time bias in Monte Carlo simulated data.

Identifiants

pubmed: 37172269
pii: 7161074
doi: 10.1093/ije/dyad049
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1534-1544

Informations de copyright

© The Author(s) 2023; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

Auteurs

In-Sun Oh (IS)

School of Pharmacy, Sungkyunkwan University, Suwon, Gyeonggi-do, South Korea.
Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.
Centre for Clinical Epidemiology, Lady Davis Research Institute-Jewish General Hospital, Montreal, Quebec, Canada.

Han Eol Jeong (HE)

School of Pharmacy, Sungkyunkwan University, Suwon, Gyeonggi-do, South Korea.
Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Gyeonggi-do, South Korea.

Hyesung Lee (H)

School of Pharmacy, Sungkyunkwan University, Suwon, Gyeonggi-do, South Korea.
Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Gyeonggi-do, South Korea.

Kristian B Filion (KB)

Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.
Centre for Clinical Epidemiology, Lady Davis Research Institute-Jewish General Hospital, Montreal, Quebec, Canada.
Department of Medicine, McGill University, Montreal, Quebec, Canada.

Yunha Noh (Y)

School of Pharmacy, Sungkyunkwan University, Suwon, Gyeonggi-do, South Korea.
Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.
Centre for Clinical Epidemiology, Lady Davis Research Institute-Jewish General Hospital, Montreal, Quebec, Canada.

Ju-Young Shin (JY)

School of Pharmacy, Sungkyunkwan University, Suwon, Gyeonggi-do, South Korea.
Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Gyeonggi-do, South Korea.
Department of Clinical Research Design & Evaluation, Samsung Advanced Institute for Health Sciences and Technology, Sungkyunkwan University, Seoul, South Korea.

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