Carolyn M Kercsmar1, Christine A Sorkness2, Agustin Calatroni3, Peter J Gergen4, Gordon R Bloomberg5, Rebecca S Gruchalla6, Meyer Kattan7, Andrew H Liu8, George T O'Connor9, Jacqueline A Pongracic10, Stanley J Szefler11, Stephen J Teach12, Jeremy J Wildfire3, Robert A Wood13, Edward M Zoratti14, William W Busse2. 1. Department of Pediatrics, University of Cincinnati College of Medicine, Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. Electronic address: carolyn.kercsmar@cchmc.org. 2. Department of Medicine, Division of Allergy and Immunology, University of Wisconsin School of Medicine and Public Health, Madison, Wis. 3. Rho Federal Systems Division, Chapel Hill, NC. 4. Division of Allergy, Immunology, and Transplantation, National Institutes of Health, Bethesda, Md. 5. Department of Pediatrics, Division of Pediatric Allergy, Immunology, and Pulmonary Medicine, Washington University School of Medicine, St Louis, Mo. 6. Department of Internal Medicine/Pediatrics, Division of Allergy and Immunology, University of Texas Southwestern Medical Center, Dallas, Tex. 7. Department of Pediatrics, Division of Pediatric Pulmonology, Columbia University College of Physicians and Surgeons, New York, NY. 8. Department of Pediatrics, Division of Pulmonary Medicine, Children's Hospital Colorado, Aurora, Colo. 9. Department of Medicine, Division of Pulmonary, Allergy, Sleep and Critical Care Medicine, Boston University School of Medicine, Boston, Mass. 10. Department of Pediatrics, Division of Allergy and Immunology, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill. 11. Department of Pediatrics, Division of Pulmonary Medicine, National Jewish Health and University of Colorado, Denver School of Medicine, Denver, Colo. 12. Department of Pediatrics, Division of Emergency Medicine and Trauma Services, Children's National Medical Center, Washington, DC. 13. Department of Pediatrics, Division of Allergy and Immunology, Johns Hopkins University School of Medicine, Baltimore, Md. 14. Department of Pediatrics, Division of Allergy and Immunology, Henry Ford Health System and Wayne State University School of Medicine, Detroit, Mich.
Abstract
BACKGROUND: Multicenter randomized controlled trials (RCTs) for asthma management that incorporate usual-care regimens could benefit from standardized application of evidence-based guidelines. OBJECTIVE: We sought to evaluate performance of a computerized decision support tool, the Asthma Control Evaluation and Treatment (ACET) Program, to standardize usual-care regimens for asthma management in RCTs. METHODS:Children and adolescents with persistent uncontrolled asthma living in urban census tracts were recruited into 3 multicenter RCTs (each with a usual-care arm) between 2004 and 2014. A computerized decision support tool scored asthma control and assigned an appropriate treatment step based on published guidelines. Control-level determinants (symptoms, rescue medication use, pulmonary function measure, and adherence estimates) were collected at visits and entered into the ACET Program. Changes in control levels and treatment steps were examined during the trials. RESULTS: At screening, more than half of the participants were rated as having symptoms that were not controlled or poorly controlled. The proportion of participants who gained good control between screening and randomization increased significantly in all 3 trials. Between 51% and 70% had symptoms that were well controlled by randomization. The proportion of well-controlled participants remained constant or improved slightly from randomization until the last posttreatment visit. Nighttime symptoms were the most common control-level determinant; there were few (<1%) instances of complete overlap of factors. FEV1 was the driver of control-level assignment in 30% of determinations. CONCLUSION: The ACET Program decision support tool facilitated standardized asthma assessment and treatment in multicenter RCTs and was associated with attaining and maintaining good asthma control in most participants.
RCT Entities:
BACKGROUND: Multicenter randomized controlled trials (RCTs) for asthma management that incorporate usual-care regimens could benefit from standardized application of evidence-based guidelines. OBJECTIVE: We sought to evaluate performance of a computerized decision support tool, the Asthma Control Evaluation and Treatment (ACET) Program, to standardize usual-care regimens for asthma management in RCTs. METHODS:Children and adolescents with persistent uncontrolled asthma living in urban census tracts were recruited into 3 multicenter RCTs (each with a usual-care arm) between 2004 and 2014. A computerized decision support tool scored asthma control and assigned an appropriate treatment step based on published guidelines. Control-level determinants (symptoms, rescue medication use, pulmonary function measure, and adherence estimates) were collected at visits and entered into the ACET Program. Changes in control levels and treatment steps were examined during the trials. RESULTS: At screening, more than half of the participants were rated as having symptoms that were not controlled or poorly controlled. The proportion of participants who gained good control between screening and randomization increased significantly in all 3 trials. Between 51% and 70% had symptoms that were well controlled by randomization. The proportion of well-controlled participants remained constant or improved slightly from randomization until the last posttreatment visit. Nighttime symptoms were the most common control-level determinant; there were few (<1%) instances of complete overlap of factors. FEV1 was the driver of control-level assignment in 30% of determinations. CONCLUSION: The ACET Program decision support tool facilitated standardized asthma assessment and treatment in multicenter RCTs and was associated with attaining and maintaining good asthma control in most participants.
Authors: Stanley J Szefler; Herman Mitchell; Christine A Sorkness; Peter J Gergen; George T O'Connor; Wayne J Morgan; Meyer Kattan; Jacqueline A Pongracic; Stephen J Teach; Gordon R Bloomberg; Peyton A Eggleston; Rebecca S Gruchalla; Carolyn M Kercsmar; Andrew H Liu; Jeremy J Wildfire; Matthew D Curry; William W Busse Journal: Lancet Date: 2008-09-20 Impact factor: 79.321
Authors: Arlene M Butz; Mona Tsoukleris; Michele Donithan; Van Doren Hsu; Kim Mudd; Ilene H Zuckerman; Mary E Bollinger Journal: Pediatrics Date: 2006-12 Impact factor: 7.124
Authors: R Evans; P J Gergen; H Mitchell; M Kattan; C Kercsmar; E Crain; J Anderson; P Eggleston; F J Malveaux; H J Wedner Journal: J Pediatr Date: 1999-09 Impact factor: 4.406
Authors: Juan P Wisnivesky; Jessica Lorenzo; Richard Lyn-Cook; Thomas Newman; Adam Aponte; Elizabeth Kiefer; Ethan A Halm Journal: Ann Allergy Asthma Immunol Date: 2008-09 Impact factor: 6.347