Exposure misclassification in propensity score-based time-to-event data analysis.
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ABSTRACT:
SUBMITTER: Yang Y
PROVIDER: S-EPMC8311974 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Propensity score analysis (PSA) is widely used in medical literature to account for confounders. Conventionally, the propensity score (PS) is calculated by a binary logistic regression model using time-fixed covariates. In the presence of time-varying treatment or exposure, the conventional method may cause bias because subjects with early and late exposure are treated as the same. In effect, subjects who are treated latter can be different from those who are treated early. Thus, the conventional PSA must be modified to address this bias. In this paper, we illustrate how to perform analysis in the presence of time-dependent exposure. We conduct a simulation study with a known treatment effect. In the simulation study, we find the PSA method that directly adjust PS estimated by either a binary logistic regression model or a Cox regression model using time-fixed covariates still introduce significant bias. On the other hand, the time-dependent PS matching can help to achieve a result approaching the true effect. After time-dependent PS matching, the matched cohort can be analyzed with conventional Cox regression model or conditional logistic regression (CLR) model with time strata. The performance is comparable to the correctly specified Cox regression model with time-varying covariates (i.e., adjusting the exposure in a multivariable model as a time-varying covariate). We further develop a function called TDPSM() for time-dependent PS matching and it is applied to a real world dataset.
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Project description:Propensity score methods (e.g., matching, weighting, subclassification) provide a statistical approach for balancing dissimilar exposure groups on baseline covariates. These methods were developed in the context of data with no hierarchical structure or clustering. Yet in many applications the data have a clustered structure that is of substantive importance, such as when individuals are nested within healthcare providers or within schools. Recent work has extended propensity score methods to a multilevel setting, primarily focusing on binary exposures. In this paper, we focus on propensity score weighting for a continuous, rather than binary, exposure in a multilevel setting. Using simulations, we compare several specifications of the propensity score: a random effects model, a fixed effects model, and a single-level model. Additionally, our simulations compare the performance of marginal versus cluster-mean stabilized propensity score weights. In our results, regression specifications that accounted for the multilevel structure reduced bias, particularly when cluster-level confounders were omitted. Furthermore, cluster mean weights outperformed marginal weights.
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Project description:Propensity-score matching is a popular analytic method to estimate the effects of treatments when using observational data. Matching on the propensity score typically requires a pool of potential controls that is larger than the number of treated or exposed subjects. The most common approach to matching on the propensity score is matching without replacement, in which each control subject is matched to at most one treated subject. Failure to find a matched control for each treated subject can lead to "bias due to incomplete matching." To avoid this bias, it is important to identify a matched control subject for each treated subject. An alternative to matching without replacement is matching with replacement, in which control subjects are allowed to be matched to multiple treated subjects. A limitation to the use of matching with replacement is that variance estimation must account for both the matched nature of the sample and for some control subjects being included in multiple matched sets. While a variance estimator has been proposed for when outcomes are continuous, no such estimator has been proposed for use with time-to-event outcomes, which are common in medical and epidemiological research. We propose a variance estimator for the hazard ratio when matching with replacement. We conducted a series of Monte Carlo simulations to examine the performance of this estimator. We illustrate the utility of matching with replacement to estimate the effect of smoking cessation counseling on survival in smokers discharged from hospital with a heart attack.
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Project description:Purpose: This analysis aimed to characterize the exposure-response relationship of bevacizumab in non-small-cell lung cancer (NSCLC) and evaluate the efficacy of SB8, a bevacizumab biosimilar, and Avastin®, the reference bevacizumab sourced from the European Union (EU), based on the exposure reported in a comparative phase III efficacy and safety study (EudraCT, 2015-004026-34; NCT02754882). Materials and methods: The overall survival (OS) and progression-free survival (PFS) data from 224 patients with steady-state trough concentrations (Css,trough) were analyzed. A parametric time-to-event (TTE) model was developed using NONMEM®, and the effects of treatments (SB8 and bevacizumab-EU) and patient demographic and clinical covariates on OS and PFS were evaluated. Simulations of median OS and PFS by bevacizumab Css,trough were conducted, and concentrations required to achieve 50% and 90% of the maximum median TTE were computed. Results: A log-logistics model with Css,trough best described the OS and PFS data. Treatment was not a predictor of the hazard for OS or PFS. Simulations revealed steep exposure-response curves with a phase of rapid rise before saturating to a plateau. The median Css,trough values of SB8 and bevacizumab-EU reported from the clinical study were on the plateaus of the exposure-response curves. The concentrations required to achieve 50% and 90% of the maximum effect were 82.4 and 92.2 μg/mL, respectively, for OS and 79.7 and 89.1 μg/mL, respectively, for PFS. Conclusion: Simulations based on the constructed TTE models for OS and PFS have well described the exposure-response relationship of bevacizumab in advanced NSCLC. The analysis demonstrated comparable efficacy between SB8 and bevacizumab-EU in terms of OS and PFS based on their exposure levels.
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Project description:Measurement error is common in epidemiology, but few studies use quantitative methods to account for bias due to mismeasurement. One potential barrier is that some intuitive approaches that readily combine with methods to account for other sources of bias, like multiple imputation for measurement error (MIME), rely on internal validation data, which are rarely available. Here, we present a reparameterized imputation approach for measurement error (RIME) that can be used with internal or external validation data. We illustrate the advantages of RIME over a naive approach that ignores measurement error and MIME using a hypothetical example and a series of simulation experiments. In both the example and simulations, we combine MIME and RIME with inverse probability weighting to account for confounding when estimating hazard ratios and counterfactual risk functions. MIME and RIME performed similarly when rich external validation data were available and the prevalence of exposure did not vary between the main study and the validation data. However, RIME outperformed MIME when validation data included only true and mismeasured versions of the exposure or when exposure prevalence differed between the data sources. RIME allows investigators to leverage external validation data to account for measurement error in a wide range of scenarios.
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Project description:Germination data are analyzed by several methods, which can be mainly classified as germination indexes and traditional regression techniques to fit non-linear parametric functions to the temporal sequence of cumulative germination. However, due to the nature of germination data, often different from other biological data, the abovementioned methods may present some limits, especially when ungerminated seeds are present at the end of an experiment. A class of methods that could allow addressing these issues is represented by the so-called "time-to-event analysis", better known in other scientific fields as "survival analysis" or "reliability analysis". There is relatively little literature about the application of these methods to germination data, and some reviews dealt only with parts of the possible approaches such as either non-parametric and semi-parametric or parametric ones. The present study aims to give a contribution to the knowledge about the reliability of these methods by assessing all the main approaches to the same germination data provided by sugar beet (Beta vulgaris L.) seeds cohorts. The results obtained confirmed that although the different approaches present advantages and disadvantages, they could generally represent a valuable tool to analyze germination data providing parameters whose usefulness depends on the purpose of the research.
| S-EPMC7285257 | biostudies-literature
Project description:The authors developed a sensitivity analysis method to address the issue of uncontrolled confounding in observational studies. In this method, the authors use a 1-dimensional function of the propensity score, which they refer to as the sensitivity function (SF), to quantify the hidden bias due to unmeasured confounders. The propensity score is defined as the conditional probability of being treated given the measured covariates. Then the authors construct SF-corrected inverse-probability-weighted estimators to draw inference on the causal treatment effect. This approach allows analysts to conduct a comprehensive sensitivity analysis in a straightforward manner by varying sensitivity assumptions on both the functional form and the coefficients in the 1-dimensional SF. Furthermore, 1-dimensional continuous functions can be well approximated by low-order polynomial structures (e.g., linear, quadratic). Therefore, even if the imposed SF is practically certain to be incorrect, one can still hope to obtain valuable information on treatment effects by conducting a comprehensive sensitivity analysis using polynomial SFs with varying orders and coefficients. The authors demonstrate the new method by implementing it in an asthma study which evaluates the effect of clinician prescription patterns regarding inhaled corticosteroids for children with persistent asthma on selected clinical outcomes.
| S-EPMC3202161 | biostudies-literature
Project description:Motivated by a genome-wide association study to discover risk variants for the progression of Age-related Macular Degeneration (AMD), we develop a computationally efficient copula-based score test, in which the dependence between bivariate progression times is taken into account. Specifically, a two-step estimation approach with numerical derivatives to approximate the score function and observed information matrix is proposed. Both parametric and weakly parametric marginal distributions under the proportional hazards assumption are considered. Extensive simulation studies are conducted to evaluate the Type I error control and power performance of the proposed method. Finally, we apply our method to a large randomized trial data, the Age-related Eye Disease Study, to identify susceptible risk variants for AMD progression. The top variants identified on Chromosome 10 show significantly differential progression profiles for different genetic groups, which are critical in characterizing and predicting the risk of progression-to-late-AMD for patients with mild to moderate AMD.
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Project description:BackgroundThe growing interest in research on the health effects of near-highway air pollutants requires an assessment of potential sources of error in exposure assignment techniques that rely on residential proximity to roadways.MethodsWe compared the amount of positional error in the geocoding process for three different data sources (parcels, TIGER and StreetMap USA) to a "gold standard" residential geocoding process that used ortho-photos, large multi-building parcel layouts or large multi-unit building floor plans. The potential effect of positional error for each geocoding method was assessed as part of a proximity to highway epidemiological study in the Boston area, using all participants with complete address information (N = 703). Hourly time-activity data for the most recent workday/weekday and non-workday/weekend were collected to examine time spent in five different micro-environments (inside of home, outside of home, school/work, travel on highway, and other). Analysis included examination of whether time-activity patterns were differentially distributed either by proximity to highway or across demographic groups.ResultsMedian positional error was significantly higher in street network geocoding (StreetMap USA = 23 m; TIGER = 22 m) than parcel geocoding (8 m). When restricted to multi-building parcels and large multi-unit building parcels, all three geocoding methods had substantial positional error (parcels = 24 m; StreetMap USA = 28 m; TIGER = 37 m). Street network geocoding also differentially introduced greater amounts of positional error in the proximity to highway study in the 0-50 m proximity category. Time spent inside home on workdays/weekdays differed significantly by demographic variables (age, employment status, educational attainment, income and race). Time-activity patterns were also significantly different when stratified by proximity to highway, with those participants residing in the 0-50 m proximity category reporting significantly more time in the school/work micro-environment on workdays/weekdays than all other distance groups.ConclusionsThese findings indicate the potential for both differential and non-differential exposure misclassification due to geocoding error and time-activity patterns in studies of highway proximity. We also propose a multi-stage manual correction process to minimize positional error. Additional research is needed in other populations and geographic settings.
| S-EPMC3907019 | biostudies-literature
Project description:BackgroundElectric health record (EHR) discontinuity, that is, receiving care outside of a given EHR system, can lead to substantial information bias. We aimed to determine whether a previously described EHR-continuity prediction model can reduce the misclassification of 4 commonly used risk scores in pharmacoepidemiology.MethodsThe study cohort consists of patients aged ≥ 65 years identified in 2 US EHR systems linked with Medicare claims data from 2007 to 2017. We calculated 4 risk scores, CHAD2DS2-VASc, HAS-BLED, combined comorbidity score (CCS), claims-based frailty index (CFI) based on information recorded in the 365 days before cohort entry, and assessed their misclassification by comparing score values based on EHR data alone versus the linked EHR-claims data. CHAD2DS2-VASc and HAS-BLED were assessed in atrial fibrillation (AF) patients, whereas CCS and CFI were assessed in the general population.ResultsOur study cohort included 204 014 patients (26 537 with nonvalvular AF) in system 1 and 115 726 patients (15 529 with nonvalvular AF) in system 2. Comparing the low versus high predicted EHR continuity in system 1, the proportion of patients with misclassification of ≥2 categories improved from 55% to 16% for CHAD2DS2-VASc, from 55% to 12% for HAS-BLED, from 37% to 16% for CCS, and from 10% to 2% for CFI. A similar pattern was found in system 2.ConclusionsUsing a previously described prediction model to identify patients with high EHR continuity may significantly reduce misclassification for the commonly used risk scores in EHR-based comparative studies.
| S-EPMC9196679 | biostudies-literature