Sample size estimation for stratified cluster randomization trial with survival endpoint
Cluster randomization trials with survival endpoint are predominantly used in drug development and clinical care research when drug treatments or interventions are delivered at a group level. Unlike conventional cluster randomization design, stratified cluster randomization design is generally considered more effective in reducing the impacts of imbalanced baseline prognostic factors and varying cluster sizes between groups when these stratification factors are adopted in the design. Failure to account for stratification and cluster size variability may lead to underpowered analysis and inaccurate sample size estimation. Apart from the sample size estimation in unstratified cluster randomization trials, there are no development of an explicit sample size formula for survival endpoint when a stratified cluster randomization design is employed. In this article, we present a closed-form sample size formula based on the stratified cluster log-rank statistics for stratified cluster randomization trials with survival endpoint. It provides an integrated solution for sample size estimation that account for cluster size variation, baseline hazard heterogeneity, and the estimated intracluster correlation coefficient based on the preliminary data. Simulation studies show that the proposed formula provides the appropriate sample size for achieving the desired statistical power under various parameter configurations. A real example of a stratified cluster randomization trial in the population with stable coronary heart disease is presented to illustrate our method.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:33 |
|---|---|
| Enthalten in: |
Statistical methods in medical research - 33(2024), 5 vom: 29. Apr., Seite 838-857 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Ni, Senmiao [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Journal Article |
|---|
| Anmerkungen: |
Date Completed 24.04.2024 Date Revised 25.04.2024 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1177/09622802241236953 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM370389891 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM370389891 | ||
| 003 | DE-627 | ||
| 005 | 20240425233352.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240330s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1177/09622802241236953 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1386.xml |
| 035 | |a (DE-627)NLM370389891 | ||
| 035 | |a (NLM)38549457 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Ni, Senmiao |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Sample size estimation for stratified cluster randomization trial with survival endpoint |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 24.04.2024 | ||
| 500 | |a Date Revised 25.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Cluster randomization trials with survival endpoint are predominantly used in drug development and clinical care research when drug treatments or interventions are delivered at a group level. Unlike conventional cluster randomization design, stratified cluster randomization design is generally considered more effective in reducing the impacts of imbalanced baseline prognostic factors and varying cluster sizes between groups when these stratification factors are adopted in the design. Failure to account for stratification and cluster size variability may lead to underpowered analysis and inaccurate sample size estimation. Apart from the sample size estimation in unstratified cluster randomization trials, there are no development of an explicit sample size formula for survival endpoint when a stratified cluster randomization design is employed. In this article, we present a closed-form sample size formula based on the stratified cluster log-rank statistics for stratified cluster randomization trials with survival endpoint. It provides an integrated solution for sample size estimation that account for cluster size variation, baseline hazard heterogeneity, and the estimated intracluster correlation coefficient based on the preliminary data. Simulation studies show that the proposed formula provides the appropriate sample size for achieving the desired statistical power under various parameter configurations. A real example of a stratified cluster randomization trial in the population with stable coronary heart disease is presented to illustrate our method | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Stratified cluster randomization trials | |
| 650 | 4 | |a sample size estimation | |
| 650 | 4 | |a survival endpoint | |
| 650 | 4 | |a varying cluster sizes | |
| 700 | 1 | |a Zhong, Zihang |e verfasserin |4 aut | |
| 700 | 1 | |a Zhao, Yang |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Feng |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Jingwei |e verfasserin |4 aut | |
| 700 | 1 | |a Yu, Hao |e verfasserin |4 aut | |
| 700 | 1 | |a Bai, Jianling |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Statistical methods in medical research |d 1997 |g 33(2024), 5 vom: 29. Apr., Seite 838-857 |w (DE-627)NLM013229338 |x 1477-0334 |7 nnns |
| 773 | 1 | 8 | |g volume:33 |g year:2024 |g number:5 |g day:29 |g month:04 |g pages:838-857 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1177/09622802241236953 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 33 |j 2024 |e 5 |b 29 |c 04 |h 838-857 | ||