Patient focused outcomes are infrequently reported in paediatric health information technology trials: A systematic review

Objective Billions of dollars have been invested in Health Information Technologies (HITs), and Randomised 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 utilising 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 3/45 (6.7%) studies reported an evaluation of adverse events. In only 14/45 (31.1%) studies was it clear that all outcomes that were measured were reported. Conclusions It is difficult to use RCTs to fully evaluate the benefits and risks of using HIT interventions in paediatric healthcare settings because patient focussed 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.