Published cases of adverse drug reactions: has the quality of reporting improved over time?
OBJECTIVE
A previous study of cases published approximately 10-30 years ago reveals that substantial improvement in the quality of adverse drug reaction (ADR) case reports is needed. Since that evaluation, recommendations are available concerning the content and formatting of case reports.


OBJECTIVE
To compare the quality of recently published ADR case reports to a previously published study of the quality of ADR case reports from 10-30 years ago. A secondary objective is to determine the quality of reporting by specialty journal.


METHODS
This was a two-phase study. Phase 1 included an assessment of the 23 patient, drug and ADR variables evaluated in the previous study to allow comparison with recently published case reports in specialty journals. Phase 2 mimicked the methods of Phase 1 with a random selection of available case reports in a 1-year period from a variety of journals.


RESULTS
For Phase 1, 19 of the 23 variables had significant differences in reporting compared with the previous study. Reporting of active diseases, social history, weight, race, other drugs and dose had frequencies ranging from 25 to 80%, which was an improvement, but affording an opportunity for greater improvement. For Phase 2, 21 of the 23 variables had significant differences compared with the previous evaluation; however illicit drug use, mechanism for ADR and route of administration had significant reductions in reporting.


CONCLUSIONS
Progress has been made in ADR case reporting quality for a variety of journals, but more improvement is required to ensure data are understandable and relatable to patient care.
University of Pittsburgh, School of Pharmacy, 918 Salk Hall, 3501 Terrace St, Pittsburgh, PA 15261, USA.
Sandra L
SL
Kane-Gill
University of Pittsburgh School of Pharmacy, Pittsburgh, Pennsylvania, USA.
Pamela L
PL
Smithburger
University of Pittsburgh School of Pharmacy, Pittsburgh, Pennsylvania, USA.
Evan A
EA
Williams
University of Pittsburgh School of Pharmacy, Pittsburgh, Pennsylvania, USA.
Maria A
MA
Felton
University of Pittsburgh School of Pharmacy, Pittsburgh, Pennsylvania, USA.
Nan
N
Wang
University of Pittsburgh School of Pharmacy, Pittsburgh, Pennsylvania, USA.
Amy L
AL
Seybert
adverse event; case report; case report guidelines; drug-related side effects and adverse reactions; quality; reports