Design choices for observational studies of the effect of exposure on disease incidence. Issue 12 (9th December 2019)

• Record Type: Journal Article
• Authors: Gail, Mitchell H; Altman, Douglas G; Cadarette, Suzanne M; Collins, Gary; Evans, Stephen JW; Sekula, Peggy; Williamson, Elizabeth; Woodward, Mark
• Is Part Of: BMJ open. Volume 9:Issue 12(2019)
• Publication Date: 2019-12-09
• Subjects: epidemiology -- epidemiology -- public health -- statistics & research methods -- health informatics -- cardiac epidemiology; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2019-031031
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : The purpose of this paper is to help readers choose an appropriate observational study design for measuring an association between an exposure and disease incidence. We discuss cohort studies, sub-samples from cohorts (case-cohort and nested case-control designs), and population-based or hospital-based case-control studies. Appropriate study design is the foundation of a scientifically valid observational study. Mistakes in design are often irremediable. Key steps are understanding the scientific aims of the study and what is required to achieve them. Some designs will not yield the information required to realise the aims. The choice of design also depends on the availability of source populations and resources. Choosing an appropriate design requires balancing the pros and cons of various designs in view of study aims and practical constraints. We compare various cohort and case-control designs to estimate the effect of an exposure on disease incidence and mention how certain design features can reduce threats to study validity.