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Glossary · Study designs

What is a prospective study?

In a prospective study the question is set first and data are collected going forward. One criterion for the prospective–retrospective split is whether data were collected after or before the research idea arose (STARD 2015, STROBE). The prospective cohort, which follows people from baseline, is one example.

A prospective study is set up before the outcomes have happened, and data are gathered going forward. For diagnostic accuracy studies, STARD 2015 calls a study prospective if the plan for data collection preceded the tests; the STROBE explanatory paper reports a usage in which the split rests on when data were collected relative to when the study idea arose. According to STARD’s explanation, when the question is set before the tests, procedures and data collection can be tailored to the protocol.

In a prospective cohort, Setia writes, the investigator defines the cohort, measures exposure and potential confounders at baseline, then follows participants and assesses the outcome. Measurements can be more accurate and uniform, which helps with exposures that depend on recall or subjective assessment. Setia lists time and cost as limitations and loss to follow-up as a source of bias. Euser and colleagues summarize the trade-off as accuracy for prospective cohorts and efficiency for retrospective ones.

Setia notes that case-control participants can also be recruited prospectively, so “prospective” should not be treated as a synonym for “cohort”, although some authors use it that way (STROBE). Nor does it mean experimental: in ICMJE’s definition a clinical trial assigns an intervention to participants going forward, and ICMJE encourages, but does not require, registration of non-trial studies in which the researchers do not determine the exposure.

Example

In a hypothetical study, patients scheduled for heart surgery are enrolled before the operation, measured at baseline, and followed at regular intervals for years while complications are recorded. The data are collected as the outcomes unfold, so the study is prospective.

A point to watch

By ICMJE’s definition a clinical trial assigns an intervention to participants going forward; on the reading of that definition, a prospective cohort in which the researchers do not assign the exposure is not an experiment. Prospective and retrospective designs should not be ranked automatically as superior and inferior (Euser and colleagues); STARD’s explanation adds that retrospective studies can sometimes reflect routine practice better, but may miss eligible patients and often yield lower-quality data.

Related terms

Guides and tools

Sources

  1. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies — BMJ, 2015
  2. STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration — BMJ Open, 2016
  3. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration — PLOS Medicine, 2007
  4. Methodology Series Module 1: Cohort Studies — Indian Journal of Dermatology, 2016
  5. Methodology Series Module 2: Case-control Studies — Indian Journal of Dermatology, 2016
  6. Cohort studies: prospective versus retrospective — Nephron Clinical Practice, 2009
  7. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals: Clinical Trials (Registration) — ICMJE