Dataset Information

Censoring for Loss to Follow-up in Time-to-event Analyses of Composite Outcomes or in the Presence of Competing Risks.

ABSTRACT: BACKGROUND:In time-to-event analyses, there is limited guidance on when persons who are lost to follow-up (LTFU) should be censored. METHODS:We simulated bias in risk estimates for: (1) a composite event of measured (outcome only observable in a patient encounter) and captured events (outcome observable outside a patient encounter); and a (2) measured or (3) captured event in the presence of a competing event of the other type, under three censoring strategies: (i) censor at the last study encounter; (ii) censor when LTFU definition is met; and (iii) a new, hybrid censoring strategy. We demonstrate the real-world impact of this decision by estimating: (1) time to acquired immune deficiency syndrome (AIDS) diagnosis or death, (2) time to initiation of antiretroviral therapy (ART), and (3) time to death before ART initiation among adults engaged in HIV care. RESULTS:For (1) our hybrid censoring strategy was least biased. In our example, 5-year risk of AIDS or death was overestimated using last-encounter censoring (25%) and under-estimated using LTFU-definition censoring (21%), compared with results from our hybrid approach (24%). Last-encounter censoring was least biased for (2). When estimating 5-year risk of ART initiation, LTFU-definition censoring underestimated risk (80% vs. 85% using last-encounter censoring). LTFU-definition censoring was least biased for (3). When estimating 5-year risk of death before ART initiation, last-encounter censoring overestimated risk (5.2% vs. 4.7% using LTFU-definition censoring). CONCLUSIONS:The least biased censoring strategy for time-to-event analyses in the presence of LTFU depends on the event and estimand of interest.

SUBMITTER: Lesko CR

PROVIDER: S-EPMC6768756 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Censoring for Loss to Follow-up in Time-to-event Analyses of Composite Outcomes or in the Presence of Competing Risks.

Lesko Catherine R CR Edwards Jessie K JK Moore Richard D RD Lau Bryan B

Epidemiology (Cambridge, Mass.) 20191101 6

<h4>Background</h4>In time-to-event analyses, there is limited guidance on when persons who are lost to follow-up (LTFU) should be censored.<h4>Methods</h4>We simulated bias in risk estimates for: (1) a composite event of measured (outcome only observable in a patient encounter) and captured events (outcome observable outside a patient encounter); and a (2) measured or (3) captured event in the presence of a competing event of the other type, under three censoring strategies: (i) censor at the l ...[more]

PMID: 31393316

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Project description:BackgroundUnderstanding the relative risk of cardiovascular versus noncardiovascular death is important for designing clinical trials. These risks may differ depending on patient age, sex, and type of acute coronary syndrome (ACS).Methods and resultsIMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) was a randomized controlled trial of simvastatin plus either ezetimibe or placebo following stabilized ACS. Cause of death was adjudicated by an independent committee. We compared the cumulative incidence of cardiovascular and noncardiovascular death for patients with unstable angina/non-ST-segment elevation myocardial infarction (UA/NSTEMI) and ST-segment elevation myocardial infarction (STEMI), in those <65 and ?65 years old, and males and females, over 7 years of follow-up. Of 18 131 patients, the presenting event was STEMI for 5190 (29%) and UA/NSTEMI for 12 941 (71%); 10 173 (56%) patients were <65 years old and 7971 (44%) were ?65 years old at presentation. UA/NSTEMI patients were older than STEMI patients, with more cardiovascular and noncardiovascular risk factors. In STEMI patients, the cumulative incidence of cardiovascular death was higher for ?4 years following the index event, after which noncardiovascular death predominated. In UA/NSTEMI patients, the cumulative incidence of cardiovascular death remained higher than noncardiovascular death over the full follow-up period. Patients ?65 years old and <65 years old had a higher incidence of cardiovascular death than noncardiovascular death over the entirety of follow-up. Female patients had a higher incidence of cardiovascular death than noncardiovascular death for ?6 years following the index event; male patients had a higher incidence of cardiovascular death than noncardiovascular death over the entirety of follow-up.ConclusionsAmong post-ACS patients enrolled in a long-term clinical trial, the relative incidence of cardiovascular and noncardiovascular death differed based on type of ACS presentation and sex, but not age. These findings further delineate long-term prognosis after ACS and should inform the design of future cardiovascular outcomes trials.

Dataset Information

Censoring for Loss to Follow-up in Time-to-event Analyses of Composite Outcomes or in the Presence of Competing Risks.

Publications

Censoring for Loss to Follow-up in Time-to-event Analyses of Composite Outcomes or in the Presence of Competing Risks.

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