Cindy Neunert1, Deirdra R Terrell2, Donald M Arnold3,4, George Buchanan5, Douglas B Cines6, Nichola Cooper7, Adam Cuker8, Jenny M Despotovic9, James N George2, Rachael F Grace10, Thomas Kühne11, David J Kuter12, Wendy Lim13, Keith R McCrae14, Barbara Pruitt15, Hayley Shimanek16, Sara K Vesely2. 1. Division of Pediatric Hematology, Oncology, and Stem Cell Transplantation, Columbia University Irving Medical Center, New York, NY. 2. Department of Biostatistics and Epidemiology, Hudson College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK. 3. Division of Hematology and Thromboembolism, Department of Medicine, and. 4. McMaster Centre for Transfusion Research, McMaster University, Toronto, ON, Canada. 5. Division of Hematology-Oncology, University of Texas Southwestern Medical Center, Dallas, TX. 6. Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. 7. Centre for Haematology, Department of Medicine, Hammersmith Hospital, Imperial College London, London, United Kingdom. 8. Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. 9. Section of Hematology-Oncology, Department of Pediatrics, College of Medicine, Baylor University, Houston, TX. 10. Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Department of Pediatrics, Harvard Medical School, Boston, MA. 11. University Children's Hospital Basel, Basel, Switzerland. 12. Department of Hematology, Massachusetts General Hospital, Harvard Medical School, Boston, MA. 13. Division of Hematology and Thromboembolism, Department of Medicine, McMaster University, Toronto, ON, Canada. 14. Department of Hematology and Medical Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH. 15. Coral Gables, FL; and. 16. Ames, IA.
Abstract
BACKGROUND: Despite an increase in the number of therapies available to treat patients with immune thrombocytopenia (ITP), there are minimal data from randomized trials to assist physicians with the management of patients. OBJECTIVE: These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians, and other health care professionals in their decisions about the management of ITP. METHODS: In 2015, ASH formed a multidisciplinary guideline panel that included 8 adult clinical experts, 5 pediatric clinical experts, 2 methodologists with expertise in ITP, and 2 patient representatives. The panel was balanced to minimize potential bias from conflicts of interest. The panel reviewed the ASH 2011 guideline recommendations and prioritized questions. The panel used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, including evidence-to-decision frameworks, to appraise evidence (up to May 2017) and formulate recommendations. RESULTS: The panel agreed on 21 recommendations covering management of ITP in adults and children with newly diagnosed, persistent, and chronic disease refractory to first-line therapy who have non-life-threatening bleeding. Management approaches included: observation, corticosteroids, IV immunoglobulin, anti-D immunoglobulin, rituximab, splenectomy, and thrombopoietin receptor agonists. CONCLUSIONS: There was a lack of evidence to support strong recommendations for various management approaches. In general, strategies that avoided medication side effects were favored. A large focus was placed on shared decision-making, especially with regard to second-line therapy. Future research should apply standard corticosteroid-dosing regimens, report patient-reported outcomes, and include cost-analysis evaluations.
BACKGROUND: Despite an increase in the number of therapies available to treat patients with immune thrombocytopenia (ITP), there are minimal data from randomized trials to assist physicians with the management of patients. OBJECTIVE: These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians, and other health care professionals in their decisions about the management of ITP. METHODS: In 2015, ASH formed a multidisciplinary guideline panel that included 8 adult clinical experts, 5 pediatric clinical experts, 2 methodologists with expertise in ITP, and 2 patient representatives. The panel was balanced to minimize potential bias from conflicts of interest. The panel reviewed the ASH 2011 guideline recommendations and prioritized questions. The panel used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, including evidence-to-decision frameworks, to appraise evidence (up to May 2017) and formulate recommendations. RESULTS: The panel agreed on 21 recommendations covering management of ITP in adults and children with newly diagnosed, persistent, and chronic disease refractory to first-line therapy who have non-life-threatening bleeding. Management approaches included: observation, corticosteroids, IV immunoglobulin, anti-D immunoglobulin, rituximab, splenectomy, and thrombopoietin receptor agonists. CONCLUSIONS: There was a lack of evidence to support strong recommendations for various management approaches. In general, strategies that avoided medication side effects were favored. A large focus was placed on shared decision-making, especially with regard to second-line therapy. Future research should apply standard corticosteroid-dosing regimens, report patient-reported outcomes, and include cost-analysis evaluations.
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