Estimands and estimators of two-level methods using return to baseline strategy for longitudinal clinical trials with incomplete daily patient reported outcomes
Returning to baseline (RTB) has been a practical method for handling missing data. Here we consider longitudinal clinical trials with daily patient reported outcomes (PROs), where efficacy endpoints are often defined as the average daily values in a cycle (such as a month or a week). The conventional method treats data at cycle level and ignores daily values. In this paper, we build a two-level constrained longitudinal data analysis (cLDA) model on daily values and propose two-level RTB method to impute daily values. Standard multiple imputation (MI) approach and likelihood-based approach are proposed and evaluated by simulations.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:33 |
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| Enthalten in: |
Journal of biopharmaceutical statistics - 33(2023), 4 vom: 04. Juli, Seite 425-438 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Jin, Man [VerfasserIn] |
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| Links: |
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| Themen: |
Journal Article |
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| Anmerkungen: |
Date Completed 26.06.2023 Date Revised 26.06.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1080/10543406.2021.1934855 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM327095768 |
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| 520 | |a Returning to baseline (RTB) has been a practical method for handling missing data. Here we consider longitudinal clinical trials with daily patient reported outcomes (PROs), where efficacy endpoints are often defined as the average daily values in a cycle (such as a month or a week). The conventional method treats data at cycle level and ignores daily values. In this paper, we build a two-level constrained longitudinal data analysis (cLDA) model on daily values and propose two-level RTB method to impute daily values. Standard multiple imputation (MI) approach and likelihood-based approach are proposed and evaluated by simulations | ||
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