目的:构建可为医保决策提供真实世界用药模式证据的指标、定义及适宜计算方法。方法:对PubMed、Embase、中国知网和中国生物医学文献数据库进行系统检索,中文检索策略为"用药模式",英文为"drug-use mode OR medicine use patterns OR drug utilization OR dosing pattern"。提取用法、用量、频率、用药方案调整等相关指标及计算方法构建问卷调查表。采用德尔菲法进行两轮专家咨询,根据结果构建最终的指标体系。结果:问卷调查表具有良好的内部一致性,两轮问卷结果表明专家对相关领域熟悉程度高,专家意见协调程度好。最终整理了常见慢性疾病、恶性肿瘤和精神类疾病3种疾病患者用药模式的指标集和适宜计算方法,常见慢性疾病患者用药模式指标集包含6个一级指标和17个二级指标,恶性肿瘤患者用药模式指标集包含6个一级指标和19个二级指标,精神类疾病患者用药模式指标集包含6个一级指标和20个二级指标。结论:该指标体系有助于将真实世界中用药模式的指标和计算方法标准化、规范化,为决策者提供更可靠的证据。
Construction of an indicator system for real-world medication patterns
OBJECTIVE To construct a set of indicators,definitions and appropriate calculation methods for providing evi-dence of real-world medication patterns for health insurance decision-making.METHODS Systematic searches were conducted from the databases of PubMed,Embase,China National Knowledge Infrastructure(CNKI)and China Biology Medicine.The searching strategies included"drug-use mode OR medicine use patterns OR drug utilization OR dosing pattern."The relevant indi-cators of usage,dosage,frequency and adjustment of dosing regimens,along with their calculation methods,were extracted for constructing a questionnaire survey form.RESULTS The questionnaire demonstrated an excellent internal consistency.The results of two rounds of questionnaires indicated a high level of familiarity among experts with the relevant fields and a decent degree of agreement in their opinions.Ultimately,sets of indicators and appropriate calculation methods were organized for the medication patterns of patients with common chronic diseases,malignant tumors and psychiatric disorders.The indicator set for medication patterns of patients with common chronic diseases included 6 primary and 17 secondary indicators.The set for malig-nant tumor patients included 6 primary and 19 secondary indicators and the set for psychiatric disorder patients had 6 primary and 20 secondary indicators.CONCLUSION This indicator system helps to standardize and normalize the indicators and calculation methods for real-world medication patterns,providing more reliable evidence for decision-makers.