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Methods in pharmacoepidemiology: a review of statistical analyses and data reporting in pediatric drug utilization studies

  • Pharmacoepidemiology and Prescription
  • Published:
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Abstract

Purpose

To evaluate the quality of data reporting and statistical methods performed in drug utilization studies in the pediatric population.

Methods

Drug utilization studies evaluating all drug prescriptions to children and adolescents published between January 1994 and December 2011 were retrieved and analyzed. For each study, information on measures of exposure/consumption, the covariates considered, descriptive and inferential analyses, statistical tests, and methods of data reporting was extracted. An overall quality score was created for each study using a 12-item checklist that took into account the presence of outcome measures, covariates of measures, descriptive measures, statistical tests, and graphical representation.

Results

A total of 22 studies were reviewed and analyzed. Of these, 20 studies reported at least one descriptive measure. The mean was the most commonly used measure (18 studies), but only five of these also reported the standard deviation. Statistical analyses were performed in 12 studies, with the chi-square test being the most commonly performed test. Graphs were presented in 14 papers. Sixteen papers reported the number of drug prescriptions and/or packages, and ten reported the prevalence of the drug prescription. The mean quality score was 8 (median 9). Only seven of the 22 studies received a score of ≥10, while four studies received a score of <6.

Conclusions

Our findings document that only a few of the studies reviewed applied statistical methods and reported data in a satisfactory manner. We therefore conclude that the methodology of drug utilization studies needs to be improved.

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Acknowledgments

The authors would like to thank Dr. Filomena Fortinguerra and Dr. Daniele Piovani for their assistance in the quality evaluation of the studies.

Conflicts of interest

None.

Author information

Authors and Affiliations

  1. Laboratory for Mother and Child Health, Department of Public Health, “Mario Negri” Institute for Pharmacological Research, via G. La Masa 19, 20156, Milan, Italy

    Marco Sequi, Rita Campi, Antonio Clavenna & Maurizio Bonati

Authors
  1. Marco Sequi
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  2. Rita Campi
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  3. Antonio Clavenna
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  4. Maurizio Bonati
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Corresponding author

Correspondence to Marco Sequi.

Appendix 1. Quality checklist (Yes = 1; No = 0)

Appendix 1. Quality checklist (Yes = 1; No = 0)

  1. a)

    Outcome measures:

    1. 1.

      Is prevalence reported?

    2. 2.

      Is drug consumption (number of prescriptions, number of medication packages) reported?

  1. b)

    Covariates:

    1. 3.

      Were the outcome measures stratified by age?

    2. 4.

      Were the outcome measures stratified by gender?

  1. c)

    Drug:

    1. 5.

      Did the analyses consider all the drugs (including OTC and nonreimbursable drugs)?

    2. 6.

      Were the outcome measures stratified by drug or drug class?

  1. d)

    Descriptive analyses:

    1. 7.

      Did the study report at least one measure of position (e.g,. mean, median)?

    2. 8.

      Did the study report at least one measure of dispersion (e.g., SD, range, 95 % CI)?

  1. e)

    Inferential analyses/tests:

    1. 9.

      Were statistical tests performed?

    2. 10.

      Were the analyses adjusted by age and/or gender?

  1. f)

    Data reporting:

    1. 11.

      Did the paper report tables?

    2. 12.

      Did the paper report graphs?

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Sequi, M., Campi, R., Clavenna, A. et al. Methods in pharmacoepidemiology: a review of statistical analyses and data reporting in pediatric drug utilization studies. Eur J Clin Pharmacol 69, 599–604 (2013). https://doi.org/10.1007/s00228-012-1354-y

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  • DOI: https://doi.org/10.1007/s00228-012-1354-y

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