Patient-focused outcomes are infrequently reported in pediatric health information technology trials: a systematic review

OBJECTIVES:Billions of dollars have been invested in Health Information Technologies (HITs), and randomized controlled trials (RCTs) have been conducted to identify the effects of these interventions. Our objective was to identify the types of outcomes that were measured and reported in these RCTs. STUDY DESIGN AND SETTING:We completed a systematic review (Medline, EMBASE, and CENTRAL databases) of RCTs involving children (<18 years) and utilizing HIT interventions. RESULTS:We identified 45 RCTs involving 323,945 children. Most studies reported process outcomes (n = 40/45 (88.9%)) but did not include patient-focused outcomes such as patient/carer functioning (n = 12/45 (26.7%)), clinical/physiological health (n = 10/45, 22.2%), quality of life (n = 3/45, 6.7%), or mortality (n = 1/45, 2.2%). Only 3 of 45 (6.7%) studies reported an evaluation of adverse events. In only 14 of 45 (31.1%) studies was it clear that all outcomes that were measured were reported. CONCLUSION:It is difficult to use RCTs to fully evaluate the benefits and risks of using HIT interventions in pediatric health care settings because patient-focused outcomes and adverse events are rarely reported. Measures to improve the quality of future trials may include the publication of study protocols and the development of an outcome reporting framework or core outcome set.