Benkirane Raja, Soulaymani-Bencheikh Rachida, Khattabi Asmae, Benabdallah Ghita, Alj Loubna, Sefiani Houda, Hedna Khedidja, Ouammi Lahcen, Olsson Sten, Pal Shanti N
Moroccan Pharmacovigilance Centre, Rabat, Morocco,
Drug Saf. 2015 Apr;38(4):383-93. doi: 10.1007/s40264-014-0257-5.
Pharmacovigilance centres (PVCs) in the World Health Organization (WHO) Programme for International Drug Monitoring have demonstrated their ability to detect preventable adverse drug reactions (ADRs) in their databases. In this field, there is no gold-standard method for detecting medication errors and evaluating ADR preventability. Therefore, we developed, from existing tools, a preventability assessment method: the 'P Method' (PM).
To present the PM and to evaluate its inter-rater reliability.
The PM includes 20 explicit criteria for assessing ADR preventability. This approach is based on identification of any potentially preventable risk factor that increases the likelihood of ADR occurrence. The outcome of the preventability assessment results in one of three possible scores: 'preventable', 'non-preventable' or 'not assessable'. The PM was tested in a multicentre study involving nine national PVCs. Two experienced reviewers at each participating PVC independently analysed the preventability of 183 ADRs, applying the PM.
The overall agreement between all reviewers for assessment of ADR preventability was 'fair', with a kappa value of 0.27 [95 % confidence interval (CI) 0.21-0.40]. The level of agreement between reviewer pairs ranged from 'slight', with a kappa value of 0.12 (95 % CI -0.03 to 0.27), to 'substantial', with a kappa value of 0.69 (95 % CI 0.48-0.89).
The analysis of the agreements and disagreements between reviewers highlighted where improvements might be made. Given that no standard assessment tool exists in the WHO Programme, the transparency of the assessment process in this method provides a substantial basis for further development and for support in signalling possible preventability.
世界卫生组织（WHO）国际药品监测计划中的药物警戒中心（PVCs）已证明其有能力在其数据库中检测出可预防的药物不良反应（ADRs）。在该领域，尚无检测用药错误和评估ADR可预防性的金标准方法。因此，我们在现有工具的基础上开发了一种可预防性评估方法：“P方法”（PM）。
介绍PM并评估其评分者间信度。
PM包括20条评估ADR可预防性的明确标准。该方法基于识别任何可能增加ADR发生可能性的潜在可预防风险因素。可预防性评估的结果为三种可能的评分之一：“可预防”、“不可预防”或“无法评估”。PM在一项涉及9个国家PVCs的多中心研究中进行了测试。每个参与的PVCs有两名经验丰富的评审员独立应用PM分析183例ADR的可预防性。
所有评审员对ADR可预防性评估的总体一致性为“中等”，kappa值为0.27 [95%置信区间（CI）0.21 - 0.40]。评审员对之间的一致性水平从“轻微”（kappa值为0.12，95% CI -0.03至0.27）到“高度”（kappa值为0.69，95% CI 0.48 - 0.89）不等。
对评审员之间的一致性和分歧进行分析，突出了可能需要改进的地方。鉴于WHO计划中不存在标准评估工具，该方法评估过程的透明度为进一步发展以及支持表明可能的可预防性提供了坚实基础。
