Journal of Clinical Apheresis 00:1–3 (2014)
Brief Report American Society for Apheresis Guidelines on the Use of Apheresis in Clinical Practice: Practical, Concise, Evidence-Based Recommendations for the Apheresis Practitioner Jeffrey L. Winters* Division of Transfusion Medicine, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota ABSTRACT The 6th Guidelines on the use of therapeutic apheresis in clinical practice published by the American Society of Apheresis provide practical, concise, and evidence based guidance for the apheresis medicine practitioner. The overall format of the Guidelines has remained unchanged with the 6th edition, compared to the 5th edition, with enhancements in the committee process of creating the guidelines. Because of changes in the writing committee structure, a number of changes have occurred in the ASFA category and recommendation grade for the use of apheresis in the treatment for a number of previously categorized clinical indications. In addition, eight new indications for apheresis, twenty three new clinical situations for previously categorized diseases, and ten new apheresis treatments for previously categorized disorders have been added. The 6th Guidelines continue to be an invaluable resource for those involved in apheresis medicine. J. Clin. Apheresis 00:000– C 2014 Wiley Periodicals, Inc. 000, 2014. V Key words: guidelines; apheresis; evidence-based medicine
INTRODUCTION
2013 ASFA GUIDELINES
In July of 2013, the American Society for Apheresis (ASFA) published their sixth guidelines on the use of therapeutic apheresis in clinical practice in the Journal of Clinical Apheresis. [1] As with previous editions [2– 16], the intent of the committee responsible for the guidelines was to provide clear, concise, practical, evidence-based guidelines for the apheresis practitioner. Such guidance is needed because of the limited quality of the medical literature dealing with therapeutic apheresis. Between 1976 and 1999, a total of 592 articles on therapeutic apheresis were published in the English language literature of which 68 (11%) represented randomized controlled clinical trials [17]. Between 2000 and 2012, the total number of published articles on therapeutic apheresis increased to 7841 of which 53 (0.7%) represented randomized controlled trials [18]. The vast majority of the apheresis literature represents moderate to low quality evidence with studies consisting of a few historic controlled trials or trials with nonrandomized controls and, most commonly, case series and case reports [1]. Because of this, there is a need for an independent, objective assessment of the apheresis literature and recommendations on the role of apheresis in the treatment of diseases.
As with the 2007 [14] and 2010 [16] ASFA guidelines, the 2013 guidelines are published as a single document with each clinical indication consisting of a one page “fact sheet” arranged in alphabetical order by disease name. Each fact sheet has a standardized format consisting of the following sections: disease name and incidence, summary of the number and types of publications evaluated, description of the disease, description of current nonapheresis treatment, rationale for therapeutic apheresis, technical notes providing disease specific information on the performance of the apheresis procedures, duration and discontinuation of the procedures, and references. These have not changed from the previous guidelines. The definitions of the ASFA categories are also unchanged from 2010 and the grading of recommendations assessment,
C 2014 Wiley Periodicals, Inc. V
*Correspondence to: Jeffrey L. Winters, M.D.; Division of Transfusion Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905. E-mail: [email protected] Received 19 May 2014; Accepted 20 May 2014 Published online 00 Month 2014 in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/jca.21334
2
Winters
TABLE I. Diseases Added to the 2013 ASFA Guidelines [1] Henoch-Sch€onlein purpura Heparin induced thrombocytopenia IgA nephropathy Lipoprotein (a) hyperlipoproteinemia Peripheral vascular disease Sudden sensorineural hearing loss Toxic epidermal necrolysis Voltage gate potassium channel antibody disease
development and evaluation (GRADE) system [19] for grading evidence is also still utilized. Significant changes in the creation of the 2013 ASFA Guidelines occurred in the process by which the committee that wrote the guidelines was constituted. Term limits on guideline authorship were implemented with authors limited to participation in three guideline documents. This was implemented to ensure that new ideas and perspectives will be incorporated into the guidelines while maintaining continuity and an understanding of the process. The goal is for roughly one third to one half of the authors being replaced with each guideline. Because of this limit, half of the 2013 guideline committee had not participated in previous guideline development. To identify new writing committee members, ASFA notified its membership through email and electronic communications that applications for the writing committee were being accepted. Interested individuals were asked to submit a resume and complete an application. The submitted materials were reviewed by Drs. Beth Shaz and Joseph Schwartz, the editors of the 2013 guidelines, who selected the new committee members. Factors considered in deciding membership included: (1) geographic location, with an attempt to ensure representation from different geographic regions in the United States; (2) medical specialty, with an attempt to ensure representation from a number of specialties; and (3) experience with different patient populations such as pediatric patients. In addition to the change in the committee membership, other changes were incorporated into the 2013 ASFA Guidelines. The University Health System Consortium level of evidence [20], implemented with the 2007 Guidelines, was eliminated as this was redundant with the more widely utilized GRADE system added with the 2010 Guidelines. The authors of each fact sheet were encouraged to provide references for all of the literature reviewed for their fact sheet, not just the most significant publications, with the result being an increase in the number of references from 815 in the 2010 ASFA Guidelines to 1,489 in the 2013 Guidelines. In addition, the references were divided into sections utilizing the disease names as headers to make finding the references for a given fact sheet easier. In Journal of Clinical Apheresis DOI 10.1002/jca
the 2007 ASFA Guidelines, Category IV indications were described in a separate publication [15] while in the 2010 ASFA Guidelines, only newly categorized ASFA Category IV indications were included. Fact sheets for diseases previously categorized as ASFA Category IV were only listed in the table with no additional detail. In the 2013 ASFA Guidelines, each Category IV indication has a fact sheet with the exact structure and format as the other fact sheets and included in the guidance document. The final changes to the 2013 ASFA Guidelines represented the categorization and grading of a number of new diseases as well as the provision of guidance for additional specific situations for previously categorized and graded disease. Eight new diseases were included in the guidelines (see Table I). In addition, 23 new clinical situations for previously categorized diseases were added to the guidelines (see Table II) and for 10 diseases, apheresis treatments not previously included in the guidelines were added and categorized (see Table III). Finally, there were a number of changes in ASFA Category or recommendation grade based on new literature or, in some circumstances, based on reevaluation of the current literature. CONCLUSIONS
As with the previous ASFA Guidelines, this document provides practical, evidence-based recommendations for the use of therapeutic apheresis in clinical practice. The guidelines are designed to be easy to use TABLE II. New Clinical Situations for Previously Categorized Diseases added to the 2013 ASFA Guidelines [1] ABO incompatible renal transplantation—Living donor ABO incompatible renal transplantation—Deceased donor, non-A1 ABO incompatible renal transplantation—Humoral rejection ABO incompatible liver transplantation—Living donor ABO incompatible liver transplantation—Deceased donor ABO incompatible liver transplantation—Humoral rejection Acute inflammatory demyelinating polyneuropathy—Prior to IVIg Acute inflammatory demyelinating polyneuropathy—IVIg failure Cardiac transplantation—Desensitization due to donor specific HLA antibodies Coagulation factor inhibitors—Alloantibodies Coagulation factor inhibitors—Autoantibody Hemolytic uremic syndrome, atypical—Inherited MCP deficiency Hemolytic uremic syndrome, infection associated—S pneumoniaassociated Inflammatory bowel disease, Ulcerative colitis Inflammatory bowel disease, Crohn’s disease—Adsorptive cytapheresis Lung allograft rejection—Antibody mediated Sickle cell disease—Priapism Sickle cell disease—Splenic sequestration Sickle cell disease—Hepatic sequestration Sickle cell disease—Intrahepatic cholestasis Sickle cell disease—Pre-operative management Sickle cell disease—Vaso-occlusive pain crisis Thrombotic microangiopathy—Clopidogrel
ASFA Guidelines TABLE III. New Treatments for Previously Categorized Diseases added to the 2013 ASFA Guidelines [1] ABO incompatible hematopoietic stem cell transplantation - Red cell exchange Immune thrombocytopenic purpura—Immunoadsorption Inflammatory bowel disease, Crohn’s disease—Extracorporeal photopheresis Acute central nervous system demyelination—Immunoadsoption Neuromyelitis optica—Maintenance plasma exchange Pemphigus vulgaris—Immunoadsorption Phytanic acid storage disease—LDL apheresis Psoriasis—Adsorptive cytapheresis Psoriasis—Lymphocytapheresis Psoriasis—Extracorporeal photopheresis
and address common clinical questions. The 2013 Guidelines have been enhanced by the addition of new diseases and clinical situations and apheresis treatments for previously categorized diseases. In addition, changes have been made in the creation of the ASFA Guideline writing committee to ensure fresh perspectives and new ideas for future guidelines while maintaining continuity with previously published guidelines. REFERENCES 1. Schwartz J, Winters JL, Padmanabhan A, Balogun R, Delaney M, Linnenberger ML, Szczepiorkowski ZM, Williams M, Wu Y, Shaz BH. Guidelines on the use of therapeutic apheresis in clinical practice—evidence-based approach from the Apheresis Applications Committee of the American Society for Apheresis. J Clin Apher 2013;28:145–284. 2. Klein HG, Balow JE, Dau P, Hamburger MI, Leitman SF, Pineda AA, Tindall RSA. Clinical applications of therapeutic apheresis. Report of the clinical applications committee American society for apheresis. J Clin Apher 1986;3:1–92. 3. Strauss RG, Ciaverella D, Gilcher RO, Kasprisin DO, Kiprov DD, Klein HG, McLeod BC. An overview of current management. J Clin Apher 1993;8:189–194. 4. Kiprov DD, Strauss RG, Ciavarella D, Gilcher RO, Kasprisin DO, Klein HG, McLeod BC. Management of autoimmune disorders. J Clin Apher 1993;8:195–210. 5. McLeod BC, Strauss RG, Ciavarella D, Gilcher RO, Kasprisin DO, Kiprov DD, Klein HG. Management of hematological disorders and cancer. J Clin Apher 1993;8:211–230. 6. Kasprisin DO, Strauss RG, Ciavarella D, Gilcher RO, Kiprov DD, Klein HG, McLeod BC. Management of metabolic and miscellaneous disorders. J Clin Apher 1993;8:231–241.
3
7. Ciavarella D, Wuest D, Strauss RG, Gilcher RO, Kasprisin DO, Kiprov DD, Klein HG, McLeod BC. Management of neurologic disorders. J Clin Apher 1993;8:242–257. 8. Gilcher RO, Strauss RG, Ciavarella D, Kasprisin DO, Kiprov DD, Klein HG, McLeod BC. Management of renal disorders. J Clin Apher 1993;8:242–257. 9. Koo AP. Therapeutic apheresis in autoimmune and rheumatic diseases. J Clin Apher 2000;15:18–27. 10. Grima KM. Therapeutic apheresis in hematological and oncological diseases. J Clin Apher 2000;15:28–52. 11. Winters JL, Pineda AA, McLeod BC, Grima KM. Therapeutic apheresis in reanl and metabolic diseases. J Clin Apher 2000;15: 53–73. 12. Weinstein R. Therapeutic apheresis in neurological diseases. J Clin Apher 2000;15:74–128. 13. Kim HC. Therapeutic pediatric apheresis. J Clin Apher 2000;15: 129–157. 14. Szczepiorkowski ZM, Bandarenko N, Kim HC, Linenberger ML, Marques MB, Sarode R, Schwartz J, Shaz BH, Weinstein R, Wirk A, Winters JL. Guidelines on the use of therapeutic apheresis in clinical practice—evidence-based approach from the Clinical Applications Committee of the American Society for Apheresis. J Clin Apher 2007;22:106–175. 15. Shaz BH, Linenberger ML, Bandarenko N, Winters JL, Kim HC, Marques MB, Sarode R, Schwartz J, Weinstein R, Wirk A, Szczepiorkowski ZM. Category IV indications for therapeutic apheresis – ASFA fourth special issue. J Clin Apher 2007;22: 176–180. 16. Szczepiorkowski ZM, Winters JL, Bandarenko N, Kim HC, Linenberger ML, Marques MB, Sarode R, Schwartz J, Weinstein R, Shaz B. Guidelines on the use of therapeutic apheresis in clinical practice—evidence-based approach from the Apheresis Applications Committee of the American Society for Apheresis. J Clin Apher 2010;25:83–177. 17. Shehata N, Kouroukis C, Kelton JG. A review of randomized controlled trials using therapeutic apheresis. Transfus Med Rev 2002;16:200–229. 18. Winters JL. Randomized controlled trials in therapeutic apheresis. J Clin Apher 2013;28:48–55. 19. Guyatt G, Cook DJ, Baumann MH, Addrizzo-Harris D, Hylek EM, Phillips EM, Raskob G, Lewis SZ, Schunemann HJ. Grading strength of recommendations and quality of evidence in clinical guidelines: report from an American college of chest physicians task force. Chest 2006;129:174–181. 20. University Health System Consortium Clinical Practice Advancement Center. Technology Assessment: Intravenous Immunoglobulin Preparations. Oak Brook IL: University HealthSystem Consortium, 1999. pp 212.
Journal of Clinical Apheresis DOI 10.1002/jca
Brief Report American Society for Apheresis Guidelines on the Use of Apheresis in Clinical Practice: Practical, Concise, Evidence-Based Recommendations for the Apheresis Practitioner Jeffrey L. Winters* Division of Transfusion Medicine, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota ABSTRACT The 6th Guidelines on the use of therapeutic apheresis in clinical practice published by the American Society of Apheresis provide practical, concise, and evidence based guidance for the apheresis medicine practitioner. The overall format of the Guidelines has remained unchanged with the 6th edition, compared to the 5th edition, with enhancements in the committee process of creating the guidelines. Because of changes in the writing committee structure, a number of changes have occurred in the ASFA category and recommendation grade for the use of apheresis in the treatment for a number of previously categorized clinical indications. In addition, eight new indications for apheresis, twenty three new clinical situations for previously categorized diseases, and ten new apheresis treatments for previously categorized disorders have been added. The 6th Guidelines continue to be an invaluable resource for those involved in apheresis medicine. J. Clin. Apheresis 00:000– C 2014 Wiley Periodicals, Inc. 000, 2014. V Key words: guidelines; apheresis; evidence-based medicine
INTRODUCTION
2013 ASFA GUIDELINES
In July of 2013, the American Society for Apheresis (ASFA) published their sixth guidelines on the use of therapeutic apheresis in clinical practice in the Journal of Clinical Apheresis. [1] As with previous editions [2– 16], the intent of the committee responsible for the guidelines was to provide clear, concise, practical, evidence-based guidelines for the apheresis practitioner. Such guidance is needed because of the limited quality of the medical literature dealing with therapeutic apheresis. Between 1976 and 1999, a total of 592 articles on therapeutic apheresis were published in the English language literature of which 68 (11%) represented randomized controlled clinical trials [17]. Between 2000 and 2012, the total number of published articles on therapeutic apheresis increased to 7841 of which 53 (0.7%) represented randomized controlled trials [18]. The vast majority of the apheresis literature represents moderate to low quality evidence with studies consisting of a few historic controlled trials or trials with nonrandomized controls and, most commonly, case series and case reports [1]. Because of this, there is a need for an independent, objective assessment of the apheresis literature and recommendations on the role of apheresis in the treatment of diseases.
As with the 2007 [14] and 2010 [16] ASFA guidelines, the 2013 guidelines are published as a single document with each clinical indication consisting of a one page “fact sheet” arranged in alphabetical order by disease name. Each fact sheet has a standardized format consisting of the following sections: disease name and incidence, summary of the number and types of publications evaluated, description of the disease, description of current nonapheresis treatment, rationale for therapeutic apheresis, technical notes providing disease specific information on the performance of the apheresis procedures, duration and discontinuation of the procedures, and references. These have not changed from the previous guidelines. The definitions of the ASFA categories are also unchanged from 2010 and the grading of recommendations assessment,
C 2014 Wiley Periodicals, Inc. V
*Correspondence to: Jeffrey L. Winters, M.D.; Division of Transfusion Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905. E-mail: [email protected] Received 19 May 2014; Accepted 20 May 2014 Published online 00 Month 2014 in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/jca.21334
2
Winters
TABLE I. Diseases Added to the 2013 ASFA Guidelines [1] Henoch-Sch€onlein purpura Heparin induced thrombocytopenia IgA nephropathy Lipoprotein (a) hyperlipoproteinemia Peripheral vascular disease Sudden sensorineural hearing loss Toxic epidermal necrolysis Voltage gate potassium channel antibody disease
development and evaluation (GRADE) system [19] for grading evidence is also still utilized. Significant changes in the creation of the 2013 ASFA Guidelines occurred in the process by which the committee that wrote the guidelines was constituted. Term limits on guideline authorship were implemented with authors limited to participation in three guideline documents. This was implemented to ensure that new ideas and perspectives will be incorporated into the guidelines while maintaining continuity and an understanding of the process. The goal is for roughly one third to one half of the authors being replaced with each guideline. Because of this limit, half of the 2013 guideline committee had not participated in previous guideline development. To identify new writing committee members, ASFA notified its membership through email and electronic communications that applications for the writing committee were being accepted. Interested individuals were asked to submit a resume and complete an application. The submitted materials were reviewed by Drs. Beth Shaz and Joseph Schwartz, the editors of the 2013 guidelines, who selected the new committee members. Factors considered in deciding membership included: (1) geographic location, with an attempt to ensure representation from different geographic regions in the United States; (2) medical specialty, with an attempt to ensure representation from a number of specialties; and (3) experience with different patient populations such as pediatric patients. In addition to the change in the committee membership, other changes were incorporated into the 2013 ASFA Guidelines. The University Health System Consortium level of evidence [20], implemented with the 2007 Guidelines, was eliminated as this was redundant with the more widely utilized GRADE system added with the 2010 Guidelines. The authors of each fact sheet were encouraged to provide references for all of the literature reviewed for their fact sheet, not just the most significant publications, with the result being an increase in the number of references from 815 in the 2010 ASFA Guidelines to 1,489 in the 2013 Guidelines. In addition, the references were divided into sections utilizing the disease names as headers to make finding the references for a given fact sheet easier. In Journal of Clinical Apheresis DOI 10.1002/jca
the 2007 ASFA Guidelines, Category IV indications were described in a separate publication [15] while in the 2010 ASFA Guidelines, only newly categorized ASFA Category IV indications were included. Fact sheets for diseases previously categorized as ASFA Category IV were only listed in the table with no additional detail. In the 2013 ASFA Guidelines, each Category IV indication has a fact sheet with the exact structure and format as the other fact sheets and included in the guidance document. The final changes to the 2013 ASFA Guidelines represented the categorization and grading of a number of new diseases as well as the provision of guidance for additional specific situations for previously categorized and graded disease. Eight new diseases were included in the guidelines (see Table I). In addition, 23 new clinical situations for previously categorized diseases were added to the guidelines (see Table II) and for 10 diseases, apheresis treatments not previously included in the guidelines were added and categorized (see Table III). Finally, there were a number of changes in ASFA Category or recommendation grade based on new literature or, in some circumstances, based on reevaluation of the current literature. CONCLUSIONS
As with the previous ASFA Guidelines, this document provides practical, evidence-based recommendations for the use of therapeutic apheresis in clinical practice. The guidelines are designed to be easy to use TABLE II. New Clinical Situations for Previously Categorized Diseases added to the 2013 ASFA Guidelines [1] ABO incompatible renal transplantation—Living donor ABO incompatible renal transplantation—Deceased donor, non-A1 ABO incompatible renal transplantation—Humoral rejection ABO incompatible liver transplantation—Living donor ABO incompatible liver transplantation—Deceased donor ABO incompatible liver transplantation—Humoral rejection Acute inflammatory demyelinating polyneuropathy—Prior to IVIg Acute inflammatory demyelinating polyneuropathy—IVIg failure Cardiac transplantation—Desensitization due to donor specific HLA antibodies Coagulation factor inhibitors—Alloantibodies Coagulation factor inhibitors—Autoantibody Hemolytic uremic syndrome, atypical—Inherited MCP deficiency Hemolytic uremic syndrome, infection associated—S pneumoniaassociated Inflammatory bowel disease, Ulcerative colitis Inflammatory bowel disease, Crohn’s disease—Adsorptive cytapheresis Lung allograft rejection—Antibody mediated Sickle cell disease—Priapism Sickle cell disease—Splenic sequestration Sickle cell disease—Hepatic sequestration Sickle cell disease—Intrahepatic cholestasis Sickle cell disease—Pre-operative management Sickle cell disease—Vaso-occlusive pain crisis Thrombotic microangiopathy—Clopidogrel
ASFA Guidelines TABLE III. New Treatments for Previously Categorized Diseases added to the 2013 ASFA Guidelines [1] ABO incompatible hematopoietic stem cell transplantation - Red cell exchange Immune thrombocytopenic purpura—Immunoadsorption Inflammatory bowel disease, Crohn’s disease—Extracorporeal photopheresis Acute central nervous system demyelination—Immunoadsoption Neuromyelitis optica—Maintenance plasma exchange Pemphigus vulgaris—Immunoadsorption Phytanic acid storage disease—LDL apheresis Psoriasis—Adsorptive cytapheresis Psoriasis—Lymphocytapheresis Psoriasis—Extracorporeal photopheresis
and address common clinical questions. The 2013 Guidelines have been enhanced by the addition of new diseases and clinical situations and apheresis treatments for previously categorized diseases. In addition, changes have been made in the creation of the ASFA Guideline writing committee to ensure fresh perspectives and new ideas for future guidelines while maintaining continuity with previously published guidelines. REFERENCES 1. Schwartz J, Winters JL, Padmanabhan A, Balogun R, Delaney M, Linnenberger ML, Szczepiorkowski ZM, Williams M, Wu Y, Shaz BH. Guidelines on the use of therapeutic apheresis in clinical practice—evidence-based approach from the Apheresis Applications Committee of the American Society for Apheresis. J Clin Apher 2013;28:145–284. 2. Klein HG, Balow JE, Dau P, Hamburger MI, Leitman SF, Pineda AA, Tindall RSA. Clinical applications of therapeutic apheresis. Report of the clinical applications committee American society for apheresis. J Clin Apher 1986;3:1–92. 3. Strauss RG, Ciaverella D, Gilcher RO, Kasprisin DO, Kiprov DD, Klein HG, McLeod BC. An overview of current management. J Clin Apher 1993;8:189–194. 4. Kiprov DD, Strauss RG, Ciavarella D, Gilcher RO, Kasprisin DO, Klein HG, McLeod BC. Management of autoimmune disorders. J Clin Apher 1993;8:195–210. 5. McLeod BC, Strauss RG, Ciavarella D, Gilcher RO, Kasprisin DO, Kiprov DD, Klein HG. Management of hematological disorders and cancer. J Clin Apher 1993;8:211–230. 6. Kasprisin DO, Strauss RG, Ciavarella D, Gilcher RO, Kiprov DD, Klein HG, McLeod BC. Management of metabolic and miscellaneous disorders. J Clin Apher 1993;8:231–241.
3
7. Ciavarella D, Wuest D, Strauss RG, Gilcher RO, Kasprisin DO, Kiprov DD, Klein HG, McLeod BC. Management of neurologic disorders. J Clin Apher 1993;8:242–257. 8. Gilcher RO, Strauss RG, Ciavarella D, Kasprisin DO, Kiprov DD, Klein HG, McLeod BC. Management of renal disorders. J Clin Apher 1993;8:242–257. 9. Koo AP. Therapeutic apheresis in autoimmune and rheumatic diseases. J Clin Apher 2000;15:18–27. 10. Grima KM. Therapeutic apheresis in hematological and oncological diseases. J Clin Apher 2000;15:28–52. 11. Winters JL, Pineda AA, McLeod BC, Grima KM. Therapeutic apheresis in reanl and metabolic diseases. J Clin Apher 2000;15: 53–73. 12. Weinstein R. Therapeutic apheresis in neurological diseases. J Clin Apher 2000;15:74–128. 13. Kim HC. Therapeutic pediatric apheresis. J Clin Apher 2000;15: 129–157. 14. Szczepiorkowski ZM, Bandarenko N, Kim HC, Linenberger ML, Marques MB, Sarode R, Schwartz J, Shaz BH, Weinstein R, Wirk A, Winters JL. Guidelines on the use of therapeutic apheresis in clinical practice—evidence-based approach from the Clinical Applications Committee of the American Society for Apheresis. J Clin Apher 2007;22:106–175. 15. Shaz BH, Linenberger ML, Bandarenko N, Winters JL, Kim HC, Marques MB, Sarode R, Schwartz J, Weinstein R, Wirk A, Szczepiorkowski ZM. Category IV indications for therapeutic apheresis – ASFA fourth special issue. J Clin Apher 2007;22: 176–180. 16. Szczepiorkowski ZM, Winters JL, Bandarenko N, Kim HC, Linenberger ML, Marques MB, Sarode R, Schwartz J, Weinstein R, Shaz B. Guidelines on the use of therapeutic apheresis in clinical practice—evidence-based approach from the Apheresis Applications Committee of the American Society for Apheresis. J Clin Apher 2010;25:83–177. 17. Shehata N, Kouroukis C, Kelton JG. A review of randomized controlled trials using therapeutic apheresis. Transfus Med Rev 2002;16:200–229. 18. Winters JL. Randomized controlled trials in therapeutic apheresis. J Clin Apher 2013;28:48–55. 19. Guyatt G, Cook DJ, Baumann MH, Addrizzo-Harris D, Hylek EM, Phillips EM, Raskob G, Lewis SZ, Schunemann HJ. Grading strength of recommendations and quality of evidence in clinical guidelines: report from an American college of chest physicians task force. Chest 2006;129:174–181. 20. University Health System Consortium Clinical Practice Advancement Center. Technology Assessment: Intravenous Immunoglobulin Preparations. Oak Brook IL: University HealthSystem Consortium, 1999. pp 212.
Journal of Clinical Apheresis DOI 10.1002/jca
