The Delphi method, a systematic, literature-based consensus process, was shown to be useful in the development of complex clinical practice guidelines for the use of albumin, nonprotein colloid, and crystalloid solutions. It is anticipated that the guidelines will assist health care providers to develop local institutional policies and procedures for the appropriate and efficient use of albumin and albumin alternatives. Institutions reviewing and updating existing local guidelines may use the University Hospital Consortium guidelines as a model for comparison.
Our findings suggest that IVIG continues to be used to treat a wide variety of conditions not specified in the product label. Furthermore, a substantial proportion of the reported off-label uses are not recommended according to evidence-based guidelines.
Clinical research published since the first evidence-based review on the role of hematopoietic stem cell transplantation (SCT) in the treatment of pediatric acute lymphoblastic leukemia (ALL) is presented and critically evaluated in this update. Treatment recommendations are provided by an expert panel. Allogeneic SCT is recommended for children who: are in second complete remission (CR2) after experiencing an early marrow relapse for precursor-B ALL; experienced primary induction failure, but subsequently achieved a CR1; have T-lineage ALL in CR2; or have ALL in third or greater remission. Although the 2005 pediatric ALL evidence-based review (EBR) recommended allogeneic SCT for children with Philadelphia chromosome positive (Ph+) ALL in CR1, preliminary tyrosine kinase inhibitor (TKI) data demonstrate that early outcomes are comparable for allogeneic SCT and chemotherapy + imatinib. Based on the evidence, autologous SCT is not recommended for ALL in CR1. Allogeneic SCT is not recommended for: T-lineage ALL in CR1; mixed-lineage leukemia (MLL)+ ALL when it is the sole adverse risk factor; isolated central nervous system (CNS) relapse in precursor-B ALL. Based on expert opinion, allogeneic SCT may be considered for hypodiploid ALL and persistent minimal residual disease [corrected] (MRD) positivity in ALL in CR1 or greater, although these are areas that need further study. Treatment recommendations pertaining to various transplantation techniques are also provided, as are areas of needed future research.
Clinical research published since the first evidence-based review on the role of hematopoietic stem cell transplantation (SCT) in the treatment of acute lymphoblastic leukemia (ALL) in adults is presented and critically evaluated in this update. Treatment recommendations changed or modified based on new evidence include: (1) myeloablative allogeneic SCT is an appropriate treatment for adult (<35 years) ALL in first complete remission for all disease risk groups; and (2) reduced-intensity conditioning may produce similar outcomes to myeloablative regimens. Treatment recommendations unchanged or strengthened by new evidence include: (1) allogeneic SCT is recommended over chemotherapy for ALL in second complete remission or greater; (2) allogeneic is superior to autologous SCT; and (3) there are similar survival outcomes after related and unrelated allogeneic SCT. New treatment recommendations based on new evidence include: (1) in the absence of a suitable allogeneic donor, autologous SCT may be an appropriate therapy, but results in a high relapse rate; (2) it is appropriate to consider cord blood transplantation for patients with no HLA well-matched donor; and (3) imatinib therapy before and/or after SCT (for Ph+ ALL) yields significantly superior survival outcomes. Areas of needed research in the treatment of adult ALL with SCT were identified and presented in the review.
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