Study designs in paediatric pharmacoepidemiology

Verhamme, Katia; Sturkenboom, Miriam

doi:10.1007/s00228-010-0930-2

Cited by 18 publications

(16 citation statements)

References 39 publications

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“…This paper describes a case series, which is a study design that cannot formally investigate causality. Case series are important for detecting potential safety signals, which need to be tested with more rigorous study designs such as case–control or cohort studies 25 …”

Section: Discussionmentioning

confidence: 99%

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Adverse events in 50 cats with allergic dermatitis receiving ciclosporin

Heinrich¹,

McKeever²,

Eisenschenk³

2011

Veterinary Dermatology

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Ciclosporin is an immunosuppressive drug that has been used to treat allergies and other immune-mediated diseases in cats, dogs and humans. Information about the adverse effects of ciclosporin in cats has been limited to smaller studies and case reports. Adverse effects in dogs are mainly gastrointestinal in nature, but humans can also experience hypertension and altered renal function. The aim of this retrospective case series study was to document the occurrence and clinical appearance of adverse events in cats receiving ciclosporin to treat allergic skin disease. The medical records of 50 cats with allergic dermatitis treated with oral ciclosporin (1.9-7.3 mg/kg/day) were reviewed. Adverse events occurred in 66% (33 cats). Adverse events likely to be associated with ciclosporin included the following: vomiting or diarrhoea within 1-8 weeks of receiving ciclosporin (24%), weight loss (16%), anorexia and subsequent hepatic lipidosis (2%) and gingival hyperplasia (2%). Other adverse events less likely to be associated with ciclosporin therapy included the following: weight gain (14%), dental tartar and gingivitis (10%), otitis (4%), chronic diarrhoea (4%), inflammatory bowel disease with indolent gastrointestinal lymphoma (2%), urinary tract infection (2%), cataract (2%), elevated liver enzymes (2%), hyperthyroidism and renal failure (2%) and transient inappropriate urination (2%). Some cats experienced multiple adverse events. Case-control studies are needed to prove cause and effect of ciclosporin with regard to these adverse events.

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Section: Discussionmentioning

confidence: 99%

“…Case series are important for detecting potential safety signals, which need to be tested with more rigorous study designs such as case-control or cohort studies. 25 This case series lists every adverse event that occurred in a population of 50 cats receiving ciclosporin to treat allergic skin disease. Table 3 summarizes these events.…”

Section: Discussionmentioning

confidence: 99%

Adverse events in 50 cats with allergic dermatitis receiving ciclosporin

Heinrich¹,

McKeever²,

Eisenschenk³

2011

Veterinary Dermatology

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“…Of these, 107 focused on a specific drug class, in particular psychotropic drugs and antibiotics . Studies on the effectiveness and safety of drug therapy in children are also lacking . Such studies are urgently needed because children are rarely included in randomized controlled trials and many drugs are prescribed off‐label .…”

Section: Discussionmentioning

confidence: 99%

The Nordic prescription databases as a resource for pharmacoepidemiological research—a literature review

Wettermark

Zoëga

Furu

et al. 2013

Pharmacoepidemiology and Drug

179

151

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“…Different study designs can be applied in pharmacoepidemiology [30,31]. Cohort studies have the advantage of allowing data collection over prolonged time periods which is more likely to capture rare exposures.…”

Section: Discussionmentioning

confidence: 99%

Comparison of two alternative study designs in assessment of medicines utilisation in neonates

Nellis

Lutsar

Varendi

et al. 2014

BMC Med Res Methodol

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BackgroundEstimates of prevalence are known to be affected by the design of cross-sectional studies. A pan-European study provided an opportunity to compare the effect of two cross-sectional study designs on estimates of medicines use.MethodsA Service evaluation survey (SES) and a web-based point-prevalence study (PPS) were conducted as part of a European study of neonatal exposure to excipients. Neonatal units from all European Union countries plus Iceland, Norway, Switzerland and Serbia were invited to participate. All medicines prescribed to neonates were recorded during three-day and one-day study periods in the SES and PPS, respectively. In the PPS individual demographic and prescription data were also collected.To compare the probabilities that a particular medicine would be reported by each study multilevel mixed effects logistic regression models with crossed random effects were applied. The relationship between medicines exposure at the unit and individual levels in the PPS data was assessed using polynomial regression with square root transformation.ResultsOf 31 invited countries 20 and 21 with 115 and 89 units joined the SES and PPS, respectively. Out of 5,572,859 live births in invited countries in 2010 a higher proportion was covered by units participating in the SES compared to the PPS (11% vs 6%, respectively; OR 1.89; 95% CI 1.87-1.89). A greater number of active pharmaceutical ingredients (API), manufacturers and trade names were registered in the SES compared to the PPS. High correlation between the two studies in frequency of use for each specified API was seen (R2 = 0.86). The average probability of a department to use a given API was greater in the SES compared to the PPS (OR 2.36; 95% CI 2.05-2.73) with higher frequency of use and longer average duration of prescription further increasing the difference. The polynomial regression model described the correlation between APIs exposure on unit and individual level well (R2 = 0.93).ConclusionThe simple data structure and longer study period of the SES resulted in improved recruitment and higher likelihood of capture for a given API. The frequency of use at the unit level appears a good surrogate of individual exposure rates.

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Study designs in paediatric pharmacoepidemiology

Cited by 18 publications

References 39 publications

Adverse events in 50 cats with allergic dermatitis receiving ciclosporin

Adverse events in 50 cats with allergic dermatitis receiving ciclosporin

The Nordic prescription databases as a resource for pharmacoepidemiological research—a literature review

Comparison of two alternative study designs in assessment of medicines utilisation in neonates

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