Quality standards for real-world research: Focus on observational database studies of comparative effectiveness

Nicolas Roche, Helen Reddel, Richard Martin, Guy Brusselle, Alberto Papi, Mike Thomas, Dirjke Postma, Vicky Thomas, Cynthia Rand, Alison Chisholm, David Price

Research output: Contribution to journalArticle

Abstract

Real-world research can use observational or clinical trial designs, in both cases putting emphasis on high external validity, to complement the classical efficacy randomized controlled trials (RCTs) with high internal validity. Real-world research is made necessary by the variety of factors that can play an important a role in modulating effectiveness in real life but are often tightly controlled in RCTs, such as comorbidities and concomitant treatments, adherence, inhalation technique, access to care, strength of doctor-caregiver communication, and socio-economic and other organizational factors. Real-world studies belong to two main categories: pragmatic trials and observational studies, which can be prospective or retrospective. Focusing on comparative database observational studies, the process aimed at ensuring high-quality research can be divided into three parts: preparation of research, analyses and reporting, and discussion of results. Key points include a priori planning of data collection and analyses, identification of appropriate database(s), proper outcomes definition, study registration with commitment to publish, bias minimization through matching and adjustment processes accounting for potential confounders, and sensitivity analyses testing the robustness of results. When these conditions are met, observational database studies can reach a sufficient level of evidence to help create guidelines (i.e., clinical and regulatory decision-making).

Original languageEnglish (US)
Pages (from-to)S99-S104
JournalAnnals of the American Thoracic Society
Volume11
Issue numberSUPPL. 2
DOIs
StatePublished - Feb 2014

Keywords

  • Database
  • Methodology
  • Observational studies
  • Quality
  • Real-world research

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

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    Roche, N., Reddel, H., Martin, R., Brusselle, G., Papi, A., Thomas, M., Postma, D., Thomas, V., Rand, C., Chisholm, A., & Price, D. (2014). Quality standards for real-world research: Focus on observational database studies of comparative effectiveness. Annals of the American Thoracic Society, 11(SUPPL. 2), S99-S104. https://doi.org/10.1513/AnnalsATS.201309-300RM