Performance of prior event rate ratio adjustment method in pharmacoepidemiology: a simulation study

Uddin, Jamal; Staa, Tjeerd van; Boer, Anthonius de; Belitser, Svetlana V.; Hoes, Arno W.; Roes, Kit C. B.; Klungel, Olaf H.

doi:10.1002/pds.3724

Cited by 27 publications

(36 citation statements)

References 20 publications

(87 reference statements)

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“…However, events were relatively few compared to other outcomes, in particular pre-treatment in those exposed to antipsychotic medication (especially atypicals). The higher risk associated with atypical compared to conventional antipsychotic medication may be explained by clinicians selecting one drug over another in ‘at risk’ patients; when prior events influence the probability of drug use, then bias may occur when using the PERR method [30]. …”

Section: Discussionmentioning

confidence: 99%

“…The method assumes that the confounding effects are constant across the prior and post exposure periods and that there is no confounder by treatment interactions [30, 31]. The PERR cannot be applied for terminal events and so was used to examine acute cardiac events, venous thromboembolism (DVT and PE), stroke and hip fracture—but not mortality.…”

Section: Methodsmentioning

confidence: 99%

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Risk of Adverse Outcomes for Older People with Dementia Prescribed Antipsychotic Medication: A Population Based e-Cohort Study

et al. 2017

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IntroductionOver recent years there has been growing evidence of increased risk of mortality associated with antipsychotic use in older people with dementia. Although this concern combined with limited evidence of efficacy has informed guidelines restricting antipsychotic prescription in this population, the use of antipsycotics remains common. Many published studies only report short-term outcomes, are restricted to examining mortality and stroke risk or have other limitations. The aim of this study was to assess adverse outcomes associated with the use of antipsychotics in older people living with dementia in Wales (UK).MethodsThis was a retrospective study of a population-based dementia cohort using the Welsh Secure Anonymised Information Linkage databank. The prior event rate ratio (PERR) was used to estimate the influence of exposure to antipsychotic medication on acute cardiac events, venous thromboembolism, stroke and hip fracture, and adjusted Cox proportional hazard models were used to compare all-cause mortality.ResultsA total of 10,339 people aged ≥65 years were identified with newly diagnosed dementia. After excluding those who did not meet the inclusion criteria, 9674 people remained in the main cohort of whom 3735 were exposed to antipsychotic medication. An increased risk of a venous thromboembolic episode [PERR 1.95, 95% confidence interval (CI) 1.83–2.0], stroke (PERR 1.41, 95% CI 1.4–1.46) and hip fracture (PERR 1.62, 95% CI 1.59–1.65) was associated with antipsychotic use. However, there was no long-term increased mortality in people exposed to antipsychotics (adjusted hazard ratio 1.06, 95% CI 0.99–1.13).ConclusionsThe increase in adverse medical events supports guidelines restricting antipsychotic use in this population.Electronic supplementary materialThe online version of this article (doi:10.1007/s40120-016-0060-6) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Risk of Adverse Outcomes for Older People with Dementia Prescribed Antipsychotic Medication: A Population Based e-Cohort Study

et al. 2017

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“…[29][30][31] In the adjusted Cox regression analysis, we considered the first occurrence of community acquired pneumonia after the index date. We used Cox proportional hazards modelling to estimate the hazard ratio for pneumonia in people receiving PPIs, adjusted for potential confounders, with 95% confidence intervals.…”

Section: Cohort Studymentioning

confidence: 99%

“…[29][30][31] This method requires that both exposed and unexposed cohorts did not receive the study drug before the index date-that is, the date at which the exposed cohort first received the prescription and the matched date for the unexposed patients. The method relies on a before and after design and is based on the assumption that the differences in outcomes between exposed and unexposed patients before receiving the treatment reflect the combined effect of confounders independently of any effect of the study drug.…”

Section: Cohort Studymentioning

confidence: 99%

“…Prior period means time before index date (proton pump inhibitor (PPi) prescription date for exposed cohort and matched date for unexposed patients); post period means time after PPi exposure confounding. 31 The follow-up of patients in the year after initial PPI prescription ran from the date of their first PPI prescription until the earliest of the anniversary of that date, the occurrence of a pneumonia event, or the study end date. For the year before the initial PPI prescription, patients were followed from the date one year before starting the PPI until the earliest of a pneumonia event or the start of the PPI.…”

Section: Cohort Studymentioning

confidence: 99%

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Community acquired pneumonia incidence before and after proton pump inhibitor prescription: population based study

Othman

Crooks

Card

2016

BMJ

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Objective To examine the risk of community acquired pneumonia before and after prescription of proton pump inhibitor (PPI) and assess whether unmeasured confounding explains this association.Design Cohort study and self controlled case series.Setting Clinical Practice Research Datalink (1990 to 2013) in UK.Participants Adult patients with a new prescription for a PPI individually matched with controls.Main outcome measures Association of community acquired pneumonia with PPI prescription estimated by three methods: a multivariable Cox model comparing risk in PPI exposed patients with controls, corrected for potential confounders; a self controlled case series; and a prior event rate ratio (PERR) analysis over the 12 month periods before and after the first PPI prescription.Results 160 000 new PPI users were examined. The adjusted Cox regression showed a risk of community acquired pneumonia 1.67 (95% confidence interval 1.55 to 1.79) times higher for patients exposed to PPI than for controls. In the self controlled case series, among 48 451 PPI exposed patients with a record of community acquired pneumonia, the incidence rate ratio was 1.19 (95% confidence interval 1.14 to 1.25) in the 30 days after PPI prescription but was higher in the 30 days before a PPI prescription (1.92, 1.84 to 2.00). The Cox regressions for prior event rate ratio similarly showed a greater increase in community acquired pneumonia in the year before than the year after PPI prescription, such that the analysis showed a reduced relative risk of pneumonia associated with PPI use (prior event rate ratio 0.91, 95% confidence interval 0.83 to 0.99).Conclusion The association between the use of PPIs and risk of community acquired pneumonia is likely to be due entirely to confounding factors.

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The IMI PROTECT project: purpose, organizational structure, and procedures

Reynolds

Kurz²,

Groot

et al. 2016

Pharmacoepidemiology and Drug

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The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT) initiative was a collaborative European project that sought to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. Initiated in 2009 and ending in 2015, PROTECT was part of the Innovative Medicines Initiative, a joint undertaking by the European Union and pharmaceutical industry. Thirty-five partners including academics, regulators, small and medium enterprises, and European Federation of Pharmaceuticals Industries and Associations companies contributed to PROTECT. Two work packages within PROTECT implemented research examining the extent to which differences in the study design, methodology, and choice of data source can contribute to producing discrepant results from observational studies on drug safety. To evaluate the effect of these differences, the project applied different designs and analytic methodology for six drug-adverse event pairs across several electronic healthcare databases and registries. This papers introduces the organizational structure and procedures of PROTECT, including how drug-adverse event and data sources were selected, study design and analyses documents were developed, and results managed centrally.

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Performance of prior event rate ratio adjustment method in pharmacoepidemiology: a simulation study

Cited by 27 publications

References 20 publications

Risk of Adverse Outcomes for Older People with Dementia Prescribed Antipsychotic Medication: A Population Based e-Cohort Study

Risk of Adverse Outcomes for Older People with Dementia Prescribed Antipsychotic Medication: A Population Based e-Cohort Study

Community acquired pneumonia incidence before and after proton pump inhibitor prescription: population based study

The IMI PROTECT project: purpose, organizational structure, and procedures

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