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50 Plasma KCE Reports 120 7. Myasthenia gravis 8. Dermatomyositis and polymyositis 9. Inclusion body myositis 10. Stiff person syndrome 11. Neuromyelitis optica Other diseases 1. Kawasaki disease 2. For treating sepsis and septic shock 3. Viral myocarditis 4. For treating respiratory syncitial virus infection Diseases under investigation 1. Chronic fatigue syndrome 2. Alzheimer disease Search strategy The search for evidence synthesis was focused on systematic reviews. Systematic reviews identified were subsequently updated with original RCT published in Medline or Embase, after the last literature search. For diseases not covered by a systematic review, published randomized controlled trials (RCT) were considered. The date of search was November 2008 and an update was performed in June 2009. Databases used were the Cochrane review database, the database of abstracts of reviews of effects (DARE) in the Centre for Reviews and Dissemination database (CRD) (http://www.crd.york.ac.uk/crdweb/), Medline and Embase. Search terms are described in appendix. Selection of studies Evidence synthesis studies were eligible if they reviewed the literature systematically on the clinical efficacy of polyvalent immunoglobulins (administrated intravenously or subcutaneously), on clinically relevant outcomes regarding morbidity / mortality / disability due to these diseases. Original studies were eligible if they were randomised controlled trials published after the last systematic review search, or after 1998 if no systematic review was found. Studies published in English, Dutch, French and Spanish were considered. When no systematic reviews or randomized controlled trial were found on the disease of interest, observational studies covering the effectiveness of IG published after 1998 were described for information. Cost-effectiveness studies were also included. Controlled trials on other interventions such as specific immunoglobulins, oral or intramuscular administration, and on other health conditions than those listed under “Scope” were excluded. In addition, the eligible references or related articles of the systematic reviews were searched for any missing publication, when evidence was lacking or conflicting.
KCE Reports 120 Plasma 51 Search results COCHRANE SYSTEMATIC REVIEWS Nineteen Cochrane Systematic Reviews (last versions) were found on the effectiveness of immunoglobulins in treating the following diseases: multiple myeloma, chronic lymphocytic leukaemia, bone marrow/stem cell transplant, isoimmune haemolytic jaundice in neonates, fetomaternal alloimmune thrombocytopenia, CMV prophylaxis in solid organ transplant, severe infections in neonates, for preventing infection in preterm and low birth weight babies, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, multifocal motor neuropathy, multiple sclerosis, paraprotein-associated peripheral neuropathies, Lambert-Eaton myasthenic syndrome, myasthenia gravis, dermatomyositis, Kawasaki disease, treating sepsis and septic shock, viral myocarditis and treating respiratory syncitial virus infection. CRD DATABASE We found 105 references on immunoglobulins, including 30 which focused on polyvalent immunoglobulins. These included 28 systematic reviews (including the 19 Cochrane reviews), 1 guideline and 1 report which fitted the selection criteria. Appraisal of evidence Relevant papers were reviewed to identify the best evidence to answer the key clinical questions. This process involved selection of relevant studies; assessment of study quality; synthesis of the results; and grading of the evidence. The critical appraisal was done for systematic reviews and additional studies. A level of evidence (high, moderate or low) was assigned to each body of evidence according to the GRADE methodology, as described by the GRADE working group (see Appendix). 23
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KCE Reports 120B Plasma i PRÉFACE
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KCE Reports 120B Plasma iii MÉTHOD
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KCE Reports 120B Plasma v En ce qui
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KCE Reports 120 Plasma 117 4.4 CONC
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KCE Reports 120 Plasma 119 FAVOURIN
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KCE Reports 120 Plasma 121 APPENDIX
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KCE Reports 120 Plasma 123 For othe
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KCE Reports 120 Plasma 125 Table 48
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KCE Reports 120 Plasma 131 Distribu
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KCE Reports 120 Plasma 137 6 REFERE
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KCE Reports 120 Plasma 139 41. Pruz
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KCE Reports 120 Plasma 145 165. Cua
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KCE reports 1. Efficacité et renta
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73. Financement du programme de soi
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