Clinical trials allow researchers to draw conclusions about the effectiveness of a treatment. However, the statistical analysis used to draw these conclusions will inevitably be complicated by the common problem of attrition. Resorting to ad hoc methods such as case deletion or mean imputation can lead to biased results, especially if the amount of missing data is high. Multiple imputation, on the other hand, provides the researcher with an approximate solution that can be generalized to a number of different data sets and statistical problems. Multiple imputation is known to be statistically valid when n is large. However, questions still remain about the validity of multiple imputation for small samples in clinical trials. In this paper we investigate the small-sample performance of several multiple imputation methods, as well as the last observation carried forward method.
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http://dx.doi.org/10.1002/sim.2231 | DOI Listing |
Stat Methods Med Res
January 2025
School of Mathematics, Sun Yat-sen University, Guangzhou, Guangdong, China.
One primary goal of precision medicine is to estimate the individualized treatment rules that optimize patients' health outcomes based on individual characteristics. Health studies with multiple treatments are commonly seen in practice. However, most existing individualized treatment rule estimation methods were developed for the studies with binary treatments.
View Article and Find Full Text PDFAJOG Glob Rep
February 2025
Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL (Steinberg, Young, Strom, Andebrhan, Perry, Barry, Holder, Roque, and Yee).
Background: In obstetrics and gynecology (OBGYN) research, gender disparities permeate through leadership, funding, promotion, mentorship, publishing, compensation, and publicity. Few studies have investigated OBGYN clinical trial leadership as it relates to investigator gender. Thus, we undertook an investigation of principal investigator (PI) gender and clinical trial success.
View Article and Find Full Text PDFDepress Anxiety
January 2025
Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Background: Individuals with mental health disorders face major barriers in accessing smoking cessation care, often due to the stigmas associated with mental disorders and addiction. Consequently, accessible population-based smoking cessation interventions are needed for this vulnerable group.
Objective: This secondary analysis utilized data from a 12-month randomized trial to examine whether an acceptance and commitment therapy-based app (iCanQuit) demonstrated greater efficacy, engagement, and satisfaction compared to a United States (US) Clinical Practice Guidelines-based app (QuitGuide) in helping adults with mental health disorders quit smoking.
Am J Epidemiol
January 2025
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Multiple imputation (MI) models can be improved with auxiliary covariates (AC), but their performance in high-dimensional data remains unclear. We aimed to develop and compare high-dimensional MI (HDMI) methods using structured and natural language processing (NLP)-derived AC in studies with partially observed confounders. We conducted a plasmode simulation with acute kidney injury as outcome and simulated 100 cohorts with a null treatment effect, incorporating creatinine labs, atrial fibrillation (AFib), and other investigator-derived confounders in the outcome generation.
View Article and Find Full Text PDFBMC Med Res Methodol
January 2025
Department of Statistics, Shahjalal University of Science and Technology, Sylhet, 3114, Bangladesh.
Background: Logistic regression is a useful statistical technique commonly used in many fields like healthcare, marketing, or finance to generate insights from binary outcomes (e.g., sick vs.
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