Assessing efficacy and safety of replacement fluids in therapeutic plasma exchange: A systematic scoping review of outcome measures used.
immunology
neurology
plasma exchange
Journal
Journal of clinical apheresis
ISSN: 1098-1101
Titre abrégé: J Clin Apher
Pays: United States
ID NLM: 8216305
Informations de publication
Date de publication:
Oct 2022
Oct 2022
Historique:
revised:
19
04
2022
received:
20
01
2022
accepted:
01
06
2022
pubmed:
22
6
2022
medline:
7
10
2022
entrez:
21
6
2022
Statut:
ppublish
Résumé
The aim of this systematic scoping review is to identify and categorize the outcome measures that have been reported in clinical studies, where therapeutic plasma exchange (TPE) has been used as an intervention in any clinical settings, excluding thrombotic thrombocytopenic purpura (TTP). We searched electronic databases using a predefined search strategy from inception to October 9, 2020. Two reviewers independently screened and extracted data. We included 42 studies (37 RCTs and 5 prospective cohort studies) grouped into six main categories (neurology, immunology, renal, rheumatology, hematology, and dermatology). Primary outcomes were defined in eight studies (19%, 8/42) and were categorized as efficacy (five studies) or patient reported outcomes (three studies). A power calculation was reported in six studies (75%, 6/8): five neurology studies (mainly patient reported outcomes) and a single immunological study (efficacy outcome). Disease-specific efficacy outcomes were dependent on the clinical setting of the population receiving TPE. Most of the trials (43%, 18/42) were undertaken in patients with neurology conditions where clear, disease-specific, clinical outcome measures were used, including neurological disability scales (11/18, 61%), change in neurological examination (9/18, 50%), and functional improvement scores (7/18, 39%). For other conditions, the reporting of disease-specific outcomes was poorly reported. Safety outcomes were mainly related to replacement fluid type rather than being disease-specific. The most common outcome reported was hypotension (19%, 8/42), and this was primarily in patients exchanged with albumin. Future clinical studies to determine which fluid replacement option is most efficacious and safe should use disease-specific outcomes, as a trial in one therapeutic area may not necessarily translate to another therapeutic area. Patient reported outcomes are not universally reported for all disease areas. Safety measures focused primarily on fluid safety.
Identifiants
pubmed: 35726507
doi: 10.1002/jca.21996
pmc: PMC9795884
doi:
Substances chimiques
Albumins
0
Types de publication
Journal Article
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
438-448Subventions
Organisme : NHS Blood and Transplant Trust Fund
ID : TF092
Organisme : Queen Mary University of London
Organisme : Systematic Review Initiative, NHS Blood and Transplant, funded by UK Blood Services
Informations de copyright
© 2022 The Authors. Journal of Clinical Apheresis published by Wiley Periodicals LLC.
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