Characteristics and quality of reporting of cluster randomized trials in children: reporting needs improvement

To describe the characteristics and quality of reporting of cluster randomized trials (CRTs) in children published from 2004 to 2010.

Four databases were searched for reports of CRTs in children (0-18 years). Characteristics of the studies were summarized and the quality of reporting assessed using consolidated standards of reporting trial-CRT (CONSORT-CRT).

Of 1,949 identified references, 106 were included. The number of published CRTs in children increased since 2004. The greatest proportion of CRTs was undertaken in Europe (29%), whereas 40% was conducted in low- and middle-income countries. Most studies were of complex rather than simple interventions (83%); were preventive rather than treatment interventions (76%); and most frequently addressed infectious disease (21%), diet/physical activity interventions (19%), health-risk behaviors (15%), and undernutrition (13%). The majority used schools as units of randomization (72%) and enrolled 1,000-10,000 children per study (51%). Reporting was generally poor, with 34% of CRTs inadequately reporting on more than half of the CONSORT-CRT criteria. Although 85% of CRTs reported that they had ethics approval for the study, consent or assent was not obtained from children in most studies.

Children-specific elements of reporting are needed to improve the quality of reporting of CRTs and consequently their planning and implementation.