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Objective: To examine the effectiveness of hospital-based comprehensive care programs in improving the quality of care for children with special health care needs., Data Sources: A systematic review was conducted using Ovid MEDLINE, CINAHL, EMBASE, PsycINFO, Sociological Abstracts SocioFile, and Web of Science., Study Selection: Evaluations of comprehensive care programs for categorical (those with single disease) and noncategorical groups of children with special health care needs were included. Selected articles were reviewed independently by 2 raters., Data Extraction: Models of care focused on comprehensive care based at least partially in a hospital setting. The main outcome measures were the proportions of studies demonstrating improvement in the Institute of Medicine's quality-of-care domains (effectiveness of care, efficiency of care, patient or family centeredness, patient safety, timeliness of care, and equity of care)., Data Synthesis: Thirty-three unique programs were included, 13 (39%) of which were randomized controlled trials. Improved outcomes most commonly reported were efficiency of care (64% [49 of 76 outcomes]), effectiveness of care (60% [57 of 95 outcomes]), and patient or family centeredness (53% [10 of 19 outcomes). Outcomes less commonly evaluated were patient safety (9% [3 of 33 programs]), timeliness of care (6% [2 of 33 programs]), and equity of care (0%). Randomized controlled trials occurred more frequently in studies evaluating categorical vs noncategorical disease populations (11 of 17 [65%] vs 2 of 16 [17%], P = .008)., Conclusions: Although positive, the evidence supporting comprehensive hospital-based programs for children with special health care needs is restricted primarily to nonexperimental studies of children with categorical diseases and is limited by inadequate outcome measures. Additional high-quality evidence with appropriate comparative groups and broad outcomes is necessary to justify continued development and growth of programs for broad groups of children with special health care needs.