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Patient consultation about a trial of therapeutic plasma exchange for complex regional pain syndrome
Author(s) -
Goebel Andreas,
Callaghan Therese,
Jones Sandra,
Bridson John
Publication year - 2018
Publication title -
journal of clinical apheresis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.697
H-Index - 46
eISSN - 1098-1101
pISSN - 0733-2459
DOI - 10.1002/jca.21662
Subject(s) - medicine , therapeutic plasma exchange , complex regional pain syndrome , pain syndrome , intensive care medicine , physical therapy , surgery
Background Complex regional pain syndrome (CRPS) is a severe post‐traumatic chronic pain condition affecting distal limbs, for which few effective treatments exist. Complex regional pain syndrome is listed in the 2016 American Society for Apheresis guidelines as an indication for plasma exchange treatment, but patient perspectives are lacking. Study design and methods We convened a “patient and public consultation exercise.” Supervised by a clinical ethicist, the case for using therapeutic plasma exchange (TPE) was presented by a researcher and two TPE experts to five patients with severe, long‐standing CRPS and to one relative. Discussions were recorded and transcribed. Results Participants supported the technology's use but expressed concern that the small trauma of repeat cannulations of CRPS unaffected limbs might theoretically cause a spread of the condition, a risk which requires highlighting when taking consent. For a preliminary trial, the participants proposed to include no less than 10, preferably 20 participants. They suggested that the threshold for a decision to conduct a definite trial based on preliminary trial results should be set no higher than 1/5 patients achieving >30% pain reduction in the preliminary trial, with half of these responders achieving >50%. The use of sham‐TPE and a long trial duration (1 year) of a definite, parallel trial was considered acceptable, provided patients would be offered voluntary swap to the other trial arm at the end of the main trial period. Conclusion These results provide pertinent patient views about TPE treatment which can inform both clinical consultation and consent procedure and the design of future trials.