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Qualitative research methods, while rising in popularity, are still a relatively underutilized tool in public health research. Usually reserved for small samples, qualitative research techniques have the potential to enhance insights gained from large questionnaires and cohort studies, both deepening the interpretation of quantitative data and generating novel hypotheses that might otherwise be missed by standard approaches; this is especially true where exposures and outcomes are new, understudied, or rapidly changing, as in a pandemic. However, methods for the conduct of qualitative research within large samples are underdeveloped. Here, we describe a novel method of applying qualitative research methods to free-text comments collected in a large epidemiologic questionnaire. Specifically, this method includes: 1) a hierarchical system of coding through content analysis; 2) a qualitative data management application; and 3) an adaptation of Cohen's κ and percent agreement statistics for use by a team of coders, applying multiple codes per record from a large codebook. The methods outlined in this paper may help direct future applications of qualitative and mixed methods within large cohort studies. [ABSTRACT FROM AUTHOR]

"Fusion" study designs combine data from different sources to answer questions that could not be answered (as well) by subsets of the data. Studies that augment main study data with validation data, as in measurement-error correction studies or generalizability studies, are examples of fusion designs. Fusion estimators, here solutions to stacked estimating functions, produce consistent answers to identified research questions using data from fusion designs. In this paper, we describe a pair of examples of fusion designs and estimators, one where we generalize a proportion to a target population and one where we correct measurement error in a proportion. For each case, we present an example motivated by human immunodeficiency virus research and summarize results from simulation studies. Simulations demonstrate that the fusion estimators provide approximately unbiased results with appropriate 95% confidence interval coverage. Fusion estimators can be used to appropriately combine data in answering important questions that benefit from multiple sources of information. [ABSTRACT FROM AUTHOR]

In this paper, we propose a framework for thinking through the design and conduct of descriptive epidemiologic studies. A well-defined descriptive question aims to quantify and characterize some feature of the health of a population and must clearly state: 1) the target population, characterized by person and place, and anchored in time; 2) the outcome, event, or health state or characteristic; and 3) the measure of occurrence that will be used to summarize the outcome (e.g. incidence, prevalence, average time to event, etc.). Additionally, 4) any auxiliary variables will be prespecified and their roles as stratification factors (to characterize the outcome distribution) or nuisance variables (to be standardized over) will be stated. We illustrate application of this framework to describe the prevalence of viral suppression on December 31, 2019, among people living with human immunodeficiency virus (HIV) who had been linked to HIV care in the United States. Application of this framework highlights biases that may arise from missing data, especially 1) differences between the target population and the analytical sample; 2) measurement error; 3) competing events, late entries, loss to follow-up, and inappropriate interpretation of the chosen measure of outcome occurrence; and 4) inappropriate adjustment. [ABSTRACT FROM AUTHOR]

Data collected from a validation substudy permit calculation of a bias-adjusted estimate of effect that is expected to equal the estimate that would have been observed had the gold standard measurement been available for the entire study population. In this paper, we develop and apply a framework for adaptive validation to determine when sufficient validation data have been collected to yield a bias-adjusted effect estimate with a prespecified level of precision. Prespecified levels of precision are decided a priori by the investigator, based on the precision of the conventional estimate and allowing for wider confidence intervals that would still be substantively meaningful. We further present an applied example of the use of this method to address exposure misclassification in a study of transmasculine/transfeminine youth and self-harm. Our method provides a novel approach to effective and efficient estimation of classification parameters as validation data accrue, with emphasis on the precision of the bias-adjusted estimate. This method can be applied within the context of any parent epidemiologic study design in which validation data will be collected and modified to meet alternative criteria given specific study or validation study objectives. [ABSTRACT FROM AUTHOR]

In this paper, we consider methods for generating draws of a binary random variable whose expectation conditional on covariates follows a logistic regression model with known covariate coefficients. We examine approximations for finding a "balancing intercept," that is, a value for the intercept of the logistic model that leads to a desired marginal expectation for the binary random variable. We show that a recently proposed analytical approximation can produce inaccurate results, especially when targeting more extreme marginal expectations or when the linear predictor of the regression model has high variance. We then formulate the balancing intercept as a solution to an integral equation, implement a numerical approximation for solving the equation based on Monte Carlo methods, and show that the approximation works well in practice. Our approach to the basic problem of the balancing intercept provides an example of a broadly applicable strategy for formulating and solving problems that arise in the design of simulation studies used to evaluate or teach epidemiologic methods. [ABSTRACT FROM AUTHOR]

An increasing number of recent studies have suggested that doubly robust estimators with cross-fitting should be used when estimating causal effects with machine learning methods. However, not all existing programs that implement doubly robust estimators support machine learning methods and cross-fitting, or provide estimates on multiplicative scales. To address these needs, we developed AIPW , a software package implementing augmented inverse probability weighting (AIPW) estimation of average causal effects in R (R Foundation for Statistical Computing, Vienna, Austria). Key features of the AIPW package include cross-fitting and flexible covariate adjustment for observational studies and randomized controlled trials (RCTs). In this paper, we use a simulated RCT to illustrate implementation of the AIPW estimator. We also perform a simulation study to evaluate the performance of the AIPW package compared with other doubly robust implementations, including CausalGAM , npcausal , tmle , and tmle3. Our simulation showed that the AIPW package yields performance comparable to that of other programs. Furthermore, we also found that cross-fitting substantively decreases the bias and improves the confidence interval coverage for doubly robust estimators fitted with machine learning algorithms. Our findings suggest that the AIPW package can be a useful tool for estimating average causal effects with machine learning methods in RCTs and observational studies. [ABSTRACT FROM AUTHOR]

The test-negative study design is often used to estimate vaccine effectiveness in influenza studies, but it has also been proposed in the context of other infectious diseases, such as cholera, dengue, or Ebola. It was introduced as a variation of the case-control design, in an attempt to reduce confounding bias due to health-care–seeking behavior, and has quickly gained popularity because of its logistic advantages. However, examination of the directed acyclic graphs that describe the test-negative design reveals that without strong assumptions, the estimated odds ratio derived under this sampling mechanism is not collapsible over the selection variable, such that the results obtained for the sampled individuals cannot be generalized to the whole population. In this paper, we show that adjustment for severity of disease can reduce this bias and, under certain assumptions, makes it possible to unbiasedly estimate a causal odds ratio. We support our findings with extensive simulations and discuss them in the context of recently published cholera test-negative studies of the effectiveness of cholera vaccines. [ABSTRACT FROM AUTHOR]