ArticleDrug safety2014
Application of a self-controlled case series study to a database study in children.
Article in Drug safety, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.
- Pharmacoepidemiological safety studies in children: a systematic review.Pharmacoepidemiology and drug safety · 2016Pooled it
- Clinical epidemiology and pharmacoepidemiology studies with real-world databases.Proceedings of the Japan Academy. Series B, Physical and biological sciences · 2022Review
- Treatment patterns of drug-naive patients with type 2 diabetes mellitus: a retrospective cohort study using a Japanese hospital database.Diabetology & metabolic syndrome · 2019Article
- Pregabalin Prescription for Neuropathic Pain and Fibromyalgia: A Descriptive Study Using Administrative Database in Japan.Pain research & management · 2018Article
- Risk of disseminated intravascular coagulation in patients with type 2 diabetes mellitus: retrospective cohort study.BMJ open · 2017Article
- Associations of Polyethylenimine-Coated AN69ST Membrane in Continuous Renal Replacement Therapy with the Intensive Care Outcomes: Observations from a Claims Database from Japan.Blood purification · 2017Observational
- Pharmacoepidemiology in Japan: medical databases and research achievements.Journal of pharmaceutical health care and sciences · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPost-marketing surveillance activities are particularly important for safety issues in children, the elderly, and patients with severe comorbidities since these populations are usually excluded from clinical trials. In addition, using electronic databases for monitoring of safety of marketed products has been of considerable interest.
objectivesThis study aimed to clarify the advantages and difficulties of the self-controlled case series method relative to cohort studies in pharmacoepidemiological studies in children, using an administrative database, and to explore the impact on results of handling the period eligible for analysis and recurrent events in different ways.
methodsDatasets of only individuals who had the outcome of interest were derived from an anonymized hospital administrative database in Japan from April 2003 through August 2011. We calculated incidence rate ratios (IRRs) and their 95 % confidence intervals (CIs) for the risks of diarrhea, bronchitis, and eczema related to palivizumab treatment in young children. The analysis included 'first diagnosed' events or 'multiple' events during an eligible period. An eligible period was defined in two ways: first-time inpatient periods of more than 3 continuous days (EPA); and a continuous period in cases where the interval between visits was below the 75th percentile of the interval between visits for patients with the same diagnosis (EPB).
resultsWe extracted data for 70,771 patients and identified 641 who were exposed to palivizumab. The age-adjusted IRRs for diarrhea, bronchitis, and eczema were 3.0 (95 % CI 1.7-5.4), 10.3 (95 % CI 8.0-13.2), and 16.9 (95 % CI 12-23), respectively, in multiple events and the EPB eligible period. The IRRs varied greatly between the two eligible periods.
conclusionsThis method could be a useful tool in pharmacoepidemiological studies in children. Careful consideration in the handling of inpatient and outpatient periods, including sensitivity analyses, is necessary because this method is a within-individual comparison.
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