Impact of information letters on the reporting rate of adverse drug reactions and the quality of the reports: a randomized controlled study
2011

Impact of Information Letters on Adverse Drug Reaction Reporting

Sample size: 151 publication 10 minutes Evidence: moderate

Author Information

Author(s): Marie-Louise Johansson, Staffan Hägg, Susanna M. Wallerstedt

Primary Institution: Sahlgrenska University Hospital, Gothenburg, Sweden

Hypothesis

Do repeated one-page ADR information letters affect the reporting rate and quality of ADR reports?

Conclusion

Repeated ADR information letters do not increase the overall ADR reporting rate but may improve the quality of the reports.

Supporting Evidence

  • The number of high quality reports was higher in intervention units than in control units.
  • More healthcare personnel in the intervention group received and read the ADR information letters.
  • The study involved a total of 151 primary healthcare units.

Takeaway

The study looked at whether sending letters about adverse drug reactions helps doctors and nurses report them better. It found that while the letters didn't make more people report, they did help improve the quality of the reports.

Methodology

A randomized controlled trial with 151 primary healthcare units divided into intervention and control groups, measuring ADR reports and quality.

Potential Biases

Potential spillover effects where control units may have received information from intervention units.

Limitations

The study had a small number of reports and strict definitions of report quality.

Participant Demographics

845 physicians and 1,423 nurses from primary healthcare units in Sweden.

Statistical Information

P-Value

0.048

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1472-6904-11-14

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