Abstract
BackgroundWith 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).MethodsOn 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.Principal FindingsWe 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).ConclusionsThere is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.
Highlights
Over the past 2 decades, the World Health Organization (WHO) has pointed to the increasing prevalence of chronic diseases and has called for a reorientation of health systems to efficiently strengthen disease prevention and control[1]
There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in randomized controlled trials (RCTs)
Patient education through various educational interventions should play an essential role for adequate understanding and managing chronic diseases[2], such as non-communicable or infectious diseases
Summary
Over the past 2 decades, the World Health Organization (WHO) has pointed to the increasing prevalence of chronic diseases and has called for a reorientation of health systems to efficiently strengthen disease prevention and control[1]. In 2009, the American Institute of Medicine developed a priority list of 100 research topics that should be addressed by comparative effectiveness research[3]; educational interventions represented about 30% of the topics in the first quartile of the priorities. To meet these requirements, we need educational interventions that have demonstrated their effectiveness for relevant outcomes. 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)
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