INSERM, U738, AP-HP (Assistance Publique des Hôpitaux de Paris), Hôpital Hôtel Dieu, Centre d'Epidémiologie Clinique, Paris, France.
PLoS One. 2012;7(8):e42934. doi: 10.1371/journal.pone.0042934. Epub 2012 Aug 16.
With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs) evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life).
On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1) patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2) surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge.
We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333) of all primary outcomes and 46% (286 of 623) of all secondary outcomes. Overall, 69% of trials (104 of 150) used at least one patient-important outcome as a primary outcome and 66% (99 of 150) as a secondary outcome. Finally, for 31% of trials (46 of 150), primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61) of primary outcomes, as compared with 54% (32 of 59) in malignant neoplasm and 18% (4 of 22) in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months).
There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.
随着慢性非传染性疾病患病率的增加，患者教育对于加强疾病防控变得越来越重要。本研究旨在系统评估已注册、正在进行的随机对照试验（RCT）评估以患者为中心结局（即衡量患者健康状况和生活质量的结局）的教育干预的程度。
2009 年 5 月 6 日，我们在世界卫生组织国际临床试验注册平台上检索了所有正在进行的 RCT。我们使用标准化的数据提取表收集数据，并确定评估的结局是否为 1）患者重要结局，如临床事件、功能状态、疼痛或生活质量，或 2）替代结局，如生物学结局、治疗依从性或患者知识。
我们从 642 项潜在合格研究中选择了 268 项，并评估了 150 项的随机样本。患者重要结局占所有主要结局的 54%（333 项中的 178 项）和所有次要结局的 46%（623 项中的 286 项）。总体而言，69%的试验（150 项中的 104 项）将至少一个患者重要结局作为主要结局，66%（150 项中的 99 项）作为次要结局。最后，31%的试验（150 项中的 46 项）的主要结局仅为替代结局。这些结果因医学领域而异。在神经精神障碍中，患者重要结局占主要结局的 84%（61 项中的 51 项），而恶性肿瘤占 54%（59 项中的 32 项），糖尿病占 18%（22 项中的 4 项）。此外，只有 35%的试验评估了干预的长期影响（即>6 个月）。
需要提高 RCT 中结局的相关性，并评估教育干预的长期影响。
