Comparison of Methods to Estimate Total Person-Time at Risk for Synthesis Studies of Incidence Rates in Observational Data

Author(s)

Clark L1, Zolotor A2, Curteis T1
1Costello Medical, Manchester, UK, 2Costello Medical, Boston, MA, USA

OBJECTIVES: Synthesis (e.g. meta-analysis) of incidence rates from observational data requires the total person-time at risk per study. While person-time can be calculated from individual participant data (IPD), for published aggregate data person-time is frequently unreported and requires estimation from the more commonly reported mean/median follow-up duration or Kaplan–Meier curves. There is no standard recommended method to estimate total person-time; here, we compare existing and novel methods.

METHODS: Brief targeted literature searches identified prostate cancer incidence studies fully reporting Kaplan–Meier curves, number at risk tables, median follow-up duration, and total person-time. Methods to estimate person-time were tested, including: multiplication of median follow-up by the number of patients; ’midpoint’ estimation, whereby the reported number of patients at risk in each interval is multiplied by the midpoint between the previous and succeeding timepoints, then summed; and calculation using pseudo-IPD from digitized Kaplan–Meier curves.

RESULTS: Three studies (Mehtälä [2020], Rompay [2019] and Seraphin [2021]) reporting the required data with different follow-up durations (14, 25 and 5 years, respectively) were identified and evaluated. Compared to reported total person-time, estimation from median follow-up yielded an under-estimate (range percentage difference vs reported: −43.23 to −24.07). Midpoint and pseudo-IPD estimation gave closer estimates (range percentage difference vs reported: −8.19 to 2.47 and −7.7 to 0.83, respectively).

CONCLUSIONS: When estimates of person-time are required (e.g. for incidence rate meta-analysis), midpoint and pseudo-IPD methods gave the best estimates. Estimation from median follow-up (the most frequent method in the literature) yielded substantial and consistent under-estimates of person-time, which inflates incidence rate estimates. Accordingly, midpoint or pseudo-IPD methods may be preferred as a unified method where data permits. Where data are limited to median follow-up, further research is required to determine whether estimation of person-time for synthesis of incidence is suitable, and potential biases should be acknowledged and explored via sensitivity analyses.

Conference/Value in Health Info

2024-11, ISPOR Europe 2024, Barcelona, Spain

Value in Health, Volume 27, Issue 12, S2 (December 2024)

Code

MSR154

Topic

Epidemiology & Public Health, Methodological & Statistical Research, Study Approaches

Topic Subcategory

Literature Review & Synthesis, Meta-Analysis & Indirect Comparisons, Missing Data

Disease

No Additional Disease & Conditions/Specialized Treatment Areas, Oncology

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