OBJECTIVE: To describe the characteristics and quality of reporting of cluster randomized trials (CRTs) in children published from 2004 to 2010. STUDY DESIGN AND SETTING: 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). RESULTS: 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. CONCLUSION: Children-specific elements of reporting are needed to improve the quality of reporting of CRTs and consequently their planning and implementation.
OBJECTIVE: To describe the characteristics and quality of reporting of cluster randomized trials (CRTs) in children published from 2004 to 2010. STUDY DESIGN AND SETTING: 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). RESULTS: 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. CONCLUSION:Children-specific elements of reporting are needed to improve the quality of reporting of CRTs and consequently their planning and implementation.
Authors: April V P Clyburne-Sherin; Pravheen Thurairajah; Mufiza Z Kapadia; Margaret Sampson; Winnie W Y Chan; Martin Offringa Journal: Trials Date: 2015-09-18 Impact factor: 2.279
Authors: Natalia Blanco; Anthony D Harris; Laurence S Magder; John A Jernigan; Sujan C Reddy; Justin O'Hagan; Kelly M Hatfield; Lisa Pineles; Eli Perencevich; Lyndsay M O'Hara Journal: JAMA Netw Open Date: 2019-10-02