Observational studies in the era of randomized trials: Finding the balance

Research output: Contribution to journalArticle

Abstract

Randomized controlled trials (RCTs) constitute the gold standard for the generation of evidence-based medicine, but may not always be feasible. Furthermore, randomization alone does not guarantee the utility of the research, as evidenced by thousands of uninformative RCTs documented in the literature. Observational studies, including longitudinal, retrospective, and case-control designs, can contribute to the body of evidence in meaningful ways, provide useful information when an RCT is unethical or not feasible, generate hypotheses for RCTs, or provide preliminary work to better inform design of future RCTs. They can also be used to study rare outcomes, risk factors, and side effects, and to examine whether results from RCTs translate into effective treatment in routine practice. Use of modern statistical techniques, both in the study design and in the analysis stage, can improve the usefulness of the evidence obtained from observational studies.

Original languageEnglish (US)
Pages (from-to)112-117
Number of pages6
JournalThe Journal of bone and joint surgery. American volume
Volume94
Issue numberSUPPL. 1
DOIs
StatePublished - Jul 18 2012

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Observational Studies
Randomized Controlled Trials
Evidence-Based Medicine
Random Allocation
Outcome Assessment (Health Care)
Research

ASJC Scopus subject areas

  • Surgery
  • Orthopedics and Sports Medicine
  • Medicine(all)

Cite this

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abstract = "Randomized controlled trials (RCTs) constitute the gold standard for the generation of evidence-based medicine, but may not always be feasible. Furthermore, randomization alone does not guarantee the utility of the research, as evidenced by thousands of uninformative RCTs documented in the literature. Observational studies, including longitudinal, retrospective, and case-control designs, can contribute to the body of evidence in meaningful ways, provide useful information when an RCT is unethical or not feasible, generate hypotheses for RCTs, or provide preliminary work to better inform design of future RCTs. They can also be used to study rare outcomes, risk factors, and side effects, and to examine whether results from RCTs translate into effective treatment in routine practice. Use of modern statistical techniques, both in the study design and in the analysis stage, can improve the usefulness of the evidence obtained from observational studies.",
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