Kane-Gill Sandra L, Smithburger Pamela L, Williams Evan A, Felton Maria A, Wang Nan, Seybert Amy L
University of Pittsburgh, School of Pharmacy, 918 Salk Hall, 3501 Terrace St, Pittsburgh, PA 15261, USA.
University of Pittsburgh School of Pharmacy, Pittsburgh, Pennsylvania, USA.
Ther Adv Drug Saf. 2015 Apr;6(2):38-44. doi: 10.1177/2042098615569725.
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.
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.
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.
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.
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.
一项对约10 - 30年前发表的病例的前期研究表明，药物不良反应（ADR）病例报告的质量需要大幅提高。自那次评估以来，已有关于病例报告内容和格式的建议。
将近期发表的ADR病例报告的质量与之前发表的一项关于10 - 30年前ADR病例报告质量的研究进行比较。第二个目的是确定专业期刊的报告质量。
这是一项分两阶段的研究。第一阶段包括对前期研究中评估的23个患者、药物和ADR变量进行评估，以便与专业期刊近期发表的病例报告进行比较。第二阶段模仿第一阶段的方法，从各类期刊中随机选取1年期间可获取的病例报告。
在第一阶段，23个变量中有19个在报告方面与前期研究存在显著差异。活动性疾病、社会史、体重、种族、其他药物和剂量的报告频率在25%至80%之间，这是一种改进，但仍有进一步提高的空间。在第二阶段，23个变量中有21个与前期评估存在显著差异；然而，非法药物使用、ADR机制和给药途径的报告显著减少。
各类期刊在ADR病例报告质量方面已取得进展，但仍需进一步改进以确保数据易于理解并与患者护理相关。
