Calvin-Lamas Marta, Pita-Fernandez Salvador, Pertega-Diaz Sonia, Rabunal-Alvarez Maria Teresa, Martín-Herranz Isabel
Servicio de Farmacia, Instituto de Investigación Biomédica de A Coruña (INIBIC), Complexo Hospitalario Universitario A Coruña (CHUAC), Sergas, Universidade da Coruña (UDC), A Coruña, Spain.
Unidad de Epidemiología Clínica y Bioestadística, Instituto de Investigación Biomédica de A Coruña (INIBIC), Complexo Hospitalario Universitario A Coruña (CHUAC), Sergas, Universidade da Coruña (UDC), A Coruña, Spain.
Eur J Hosp Pharm. 2018 Sep;25(5):251-256. doi: 10.1136/ejhpharm-2017-001282. Epub 2017 Aug 26.
To establish a method for evaluating the complexity of clinical trials (CTs) from the perspective of a pharmacy service (PS) and to analyse the complexity of CTs carried out in a tertiary level hospital.
An observational, prevalence and retrospective study was carried out in a Spanish tertiary level hospital during the period 2008-2013. A scale of complexity was developed, whose internal consistency was determined by Cronbach's alpha. The study involved five steps: an analysis of the activities involved, score allocation to the activities, identification of CTs started in the study period, data collection and assessment of the complexity. Three complexity levels were determined: low, medium and high. The variables calculated were mean overall complexity, mean complexity per medical specialty, per pathology, per phase of CT, per initiation year and percentage of CTs by complexity level.
Cronbach's alpha of the scale of complexity was 0.738. The two most influential items were dose preparation and number of professionals involved. 55.0% of CTs were in the medium level of complexity and 12.1% of CTs were in the high level. The mean complexity of CTs studied was 13.3±4.7 (median 12, range 6-32). Statistically significant differences were found in the complexity values between CTs of different medical specialties, pathologies, phase and dose preparation in the PS (p<0.001).
The scale designed to evaluate the complexity of CTs had internal consistency. More than half of the CTs are in the medium level if complexity. The largest number of CTs with a high level of complexity were in rheumatology and oncology.
从药学服务（PS）角度建立一种评估临床试验（CT）复杂性的方法，并分析在一家三级医院开展的CT的复杂性。
于2008 - 2013年期间在一家西班牙三级医院开展了一项观察性、患病率及回顾性研究。制定了一个复杂性量表，其内部一致性通过克朗巴哈系数（Cronbach's alpha）确定。该研究包括五个步骤：分析所涉及的活动、为活动分配分数、确定研究期间启动的CT、数据收集以及复杂性评估。确定了三个复杂性级别：低、中、高。计算的变量包括平均总体复杂性、每个医学专科、每种病理、CT的每个阶段、每个启动年份的平均复杂性以及按复杂性级别划分的CT百分比。
复杂性量表的克朗巴哈系数为0.738。两个最具影响力的项目是剂量准备和涉及的专业人员数量。55.0%的CT处于中等复杂性水平，12.1%的CT处于高复杂性水平。所研究的CT的平均复杂性为13.3±4.7（中位数12，范围6 - 32）。在PS中，不同医学专科、病理、阶段和剂量准备的CT之间的复杂性值存在统计学显著差异（p<0.001）。
设计用于评估CT复杂性的量表具有内部一致性。超过一半的CT处于中等复杂性水平。复杂性水平高的CT数量最多的是在风湿病学和肿瘤学领域。
