An analysis of the exclusion criteria used in observational pharmacoepidemiological studies

Perrio, Michael J.; Waller, P.J.; Shakir, Saad

doi:10.1002/pds.1262

Cited by 16 publications

(10 citation statements)

References 19 publications

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“…Investigators struggle to design non‐randomized studies that obtain findings as credible as those from randomized controlled trials. To achieve that credibility, they restrict the question, the design, and the analysis . However, investigators designing non‐randomized studies typically cannot achieve the additional credibility attained through blinding or masking patients and providers to the interventions…”

Section: Issues That Motivate the Incident User Designmentioning

confidence: 99%

The incident user design in comparative effectiveness research

Johnson

Bartman

Briesacher

et al. 2012

Pharmacoepidemiology and Drug

196

189

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Comparative effectiveness research includes cohort studies and registries of interventions. When investigators design such studies, how important is it to follow patients from the day they initiated treatment with the study interventions? Our article considers this question and related issues to start a dialogue on the value of the incident user design in comparative effectiveness research. By incident user design, we mean a study that sets the cohort's inception date according to patients' new use of an intervention. In contrast, most epidemiologic studies enroll patients who were currently or recently using an intervention when follow-up began. We take the incident user design as a reasonable default strategy because it reduces biases that can impact non-randomized studies, especially when investigators use healthcare databases. We review case studies where investigators have explored the consequences of designing a cohort study by restricting to incident users, but most of the discussion has been informed by expert opinion, not by systematic evidence.

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Section: Issues That Motivate the Incident User Designmentioning

confidence: 99%

The incident user design in comparative effectiveness research

Johnson

Bartman

Briesacher

et al. 2012

Pharmacoepidemiology and Drug

196

189

View full text Add to dashboard Cite

show abstract

“…There are many different approaches to restriction in specific studies [37] and it is therefore difficult to provide generic advice that fits specific study designs. However, several guiding principles can be identified that should be considered in a nonrandomized database study on effectiveness and safety of medical interventions [38].…”

Section: Restriction—inclusion and Exclusion Criteriamentioning

confidence: 99%

Good Research Practices for Comparative Effectiveness Research: Approaches to Mitigate Bias and Confounding in the Design of Nonrandomized Studies of Treatment Effects Using Secondary Data Sources: The International Society for Pharmacoeconomics and Outcomes Research Good Research Practices for Retrospective Database Analysis Task Force Report—Part II

et al. 2009

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“…Researchers reduce prevalent user bias by restricting samples to new, or incident, users of study medications [9]. This is achieved through identifying and excluding patients that exhibit previous use of the study medication in claims data during a pre-index date ‘washout period’ [4,5].…”

Section: Introductionmentioning

confidence: 99%

Revisiting the washout period in the incident user study design: why 6–12 months may not be sufficient

Roberts

Dusetzina

Farley³

2015

J. Comp. Eff. Res.

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Aims The purpose of this study was to describe how washout period duration affects the size and accuracy of retrospective incident user cohorts. Materials & methods MarketScan commercial claims data from 2007 to 2010 were used and included adults with an antihyperlipidemic, antidiabetic or antidepressant claim in 2010. Incident user cohorts using 3-, 6-, 12-, 24- and 36-month washouts were created and changes in sample size and incident user misclassification were described. Results & conclusion The 6- and 12-month washouts excluded 75 and 85% of the samples, respectively. Half of subjects in the 6-month washout cohorts were actually prevalent users, and the 12-month washout period resulted in 30% misclassified. Using common washout periods of 6–12 months may insufficiently address prevalent user bias in large commercial claims databases.

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An analysis of the exclusion criteria used in observational pharmacoepidemiological studies

Abstract: There are important differences between investigators in the application of exclusion criteria in pharmacoepidemiological studies. It is likely that a substantial part of the observed variation reflects different research practices of investigators.

Cited by 16 publications

References 19 publications

The incident user design in comparative effectiveness research

The incident user design in comparative effectiveness research

Revisiting the washout period in the incident user study design: why 6–12 months may not be sufficient

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