Persson Rebecca, Hagberg Katrina Wilcox, Vasilakis-Scaramozza Catherine, Yelland Eleanor, Williams Tim, Myles Puja, Jick Susan S
Boston Collaborative Drug Surveillance Program, Lexington, MA, USA.
Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory Agency, London, UK.
Clin Epidemiol. 2022 May 3;14:641-652. doi: 10.2147/CLEP.S360843. eCollection 2022.
Assessments of strengths and limitations of new data sources are critical for making decisions about suitability for specific research questions. For some studies, it is necessary to capture a drug's indication for use.
To assess the presence of indications for prescription use in Clinical Practice Research Datalink (CPRD) Aurum (January 1988-June 2021) by describing the proportion of men in CPRD Aurum who had a recorded indication for use of prescriptions for 5-alpha reductase inhibitors (5-ARI), alpha blockers (AB), or tadalafil, which have multiple indications.
From a random sample of 154 practices of CPRD Aurum data, we selected 85,597 male patients with a prescription for a 5-ARI, an AB, or tadalafil. Among these patients, we described presence of codes indicating whether the patient had benign prostatic hyperplasia, hypertension, erectile dysfunction, or alopecia using three indication definitions: narrow (specific diagnoses recorded within one year before and up to 90 days after the prescription), broad (specific diagnoses or supporting clinical codes in the time period described above), and widest (diagnoses or supporting codes recorded at any time before the prescription and up to 90 days after the prescription).
Using the narrow indication definition limited to diagnoses only, 39,861 (46.6%) patients' records contained an indication for use. The broad definitions, which additionally included supporting codes, captured indications for 62,912 (73.5%) patients and the widest definition, which additionally included supporting codes and all available data before the first prescription date, captured indications for 71,478 (83.5%) patients. Indications were present more often for prescriptions in 2005 and later (85.9%).
The findings of this assessment suggest that CPRD Aurum can be used for studies that require information on treatment indications for BPH and potentially for treatments of other chronic diseases managed in the primary care setting.
评估新数据源的优势和局限性对于决定其是否适合特定研究问题至关重要。对于某些研究，有必要获取药物的使用指征。
通过描述临床实践研究数据链（CPRD）金数据（1988年1月至2021年6月）中男性患者使用5α还原酶抑制剂（5-ARI）、α受体阻滞剂（AB）或他达拉非（有多种适应症）的处方记录中有使用指征的比例，评估CPRD金数据中处方使用指征的存在情况。
从CPRD金数据的154个医疗机构的随机样本中，我们选择了85597名开具5-ARI、AB或他达拉非处方的男性患者。在这些患者中，我们使用三种指征定义描述了表明患者是否患有良性前列腺增生、高血压、勃起功能障碍或脱发的编码的存在情况：狭义（在处方前一年至处方后90天内记录的特定诊断）、广义（上述时间段内的特定诊断或支持性临床编码）和最广义（在处方前任何时间至处方后90天内记录的诊断或支持性编码）。
使用仅限于诊断的狭义指征定义，39861名（46.6%）患者的记录包含使用指征。广义定义（额外包括支持性编码）涵盖了62912名（73.5%）患者的指征，最广义定义（额外包括支持性编码以及首次处方日期之前的所有可用数据）涵盖了71478名（83.5%）患者的指征。2005年及以后开具的处方中更常出现指征（85.9%）。
本次评估结果表明，CPRD金数据可用于需要前列腺增生治疗指征信息以及可能用于基层医疗环境中管理的其他慢性病治疗研究。
