An international study to explore the feasibility of collecting standardised outcome data for Complex Regional Pain Syndrome: recommendations for an international clinical research registry
An international study to explore the feasibility of collecting standardised outcome data for Complex Regional Pain Syndrome: recommendations for an international clinical research registry
Introduction: Complex Regional Pain Syndrome (CRPS) is a persistent pain condition with low prevalence. Multi-centre collaborative research is needed to attain sufficient sample sizes for meaningful studies. This international observational study: (1) tested the feasibility and acceptability of collecting outcome data using an agreed core measurement set (2) tested and refined an electronic data management system to collect and manage the data.
Methods: adults with CRPS, meeting the Budapest diagnostic clinical criteria, were recruited to the study from 7 international research centres. After informed consent, a questionnaire comprising the core set outcome measures was completed: on paper at baseline (T1), and at 3 or 6 months (T2) using a paper or e-version. Participants and clinicians provided feedback on the data collection process. Clinicians completed the CRPS severity score at T1 and optionally, at T2. Ethical approval was obtained at each international centre.
Results: ninety-eight adults were recruited (female n=66; mean age 46.6 years, range 19-89), of whom 32% chose to receive the T2 questionnaire in an electronic format. Fifty-five participants completed both T1 and T2. Eighteen participants and nine clinicians provided feedback on their data collection experience.
Conclusion: this study confirmed the questionnaire core outcome data are feasible and practicable to collect in clinical practice. The electronic data management system provided a robust means of collecting and managing the data across an international population. The findings have informed the final data collection tools and processes which will comprise the first international, clinical research registry and data bank for CRPS.
Complex regional pain syndrome, core measurement set, feasibility study, international registry, pain measurement
468-478
Grieve, Sharon
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Brunner, Florian
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Cabral, Danylo
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Connett, Robyn
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Hirata, Hitoshi
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Iwasaki, Norimasa
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Nakagawa, Yasunobu
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Sagir, Afrin
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Vatine, Jean-Jacques
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Vaughan-Spickers, Nicole
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Xu, Jijun
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Buckle, Lisa
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McCabe, Candida
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October 2023
Grieve, Sharon
7e6c6d5f-df44-4327-86d7-bc31c9c157cc
Brunner, Florian
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Cabral, Danylo
ae54cc84-a212-4d1d-bfa9-b3ef77efbdc8
Connett, Robyn
2439a9b1-fac8-482e-8529-14cd357c8868
Hirata, Hitoshi
ea3b3f0d-7d82-4779-9494-1e8115ba3e8f
Iwasaki, Norimasa
e727b707-8378-4111-9fd3-fe73e6f3378f
Nakagawa, Yasunobu
3c7cb291-d6e3-4205-8b6f-f2a0475137a6
Sagir, Afrin
40bca1dc-29d3-432f-8873-268155e3f745
Vatine, Jean-Jacques
09225ba5-3cb7-4fcd-98f2-975c40f169b4
Vaughan-Spickers, Nicole
d4bc6005-6bea-4fa6-8b4d-fb211a4bb0dc
Xu, Jijun
bd49abb1-c4dc-4c90-9591-c913231e6653
Buckle, Lisa
637c5896-ae97-4d05-91c7-9aa3173c10dd
McCabe, Candida
fd44eda1-aa87-45e2-a1e7-30f06b628501
Grieve, Sharon, Brunner, Florian, Cabral, Danylo, Connett, Robyn, Hirata, Hitoshi, Iwasaki, Norimasa, Nakagawa, Yasunobu, Sagir, Afrin, Vatine, Jean-Jacques, Vaughan-Spickers, Nicole, Xu, Jijun, Buckle, Lisa and McCabe, Candida
(2023)
An international study to explore the feasibility of collecting standardised outcome data for Complex Regional Pain Syndrome: recommendations for an international clinical research registry.
British Journal of Pain, 17 (5), .
(doi:10.1177/20494637231188333).
Abstract
Introduction: Complex Regional Pain Syndrome (CRPS) is a persistent pain condition with low prevalence. Multi-centre collaborative research is needed to attain sufficient sample sizes for meaningful studies. This international observational study: (1) tested the feasibility and acceptability of collecting outcome data using an agreed core measurement set (2) tested and refined an electronic data management system to collect and manage the data.
Methods: adults with CRPS, meeting the Budapest diagnostic clinical criteria, were recruited to the study from 7 international research centres. After informed consent, a questionnaire comprising the core set outcome measures was completed: on paper at baseline (T1), and at 3 or 6 months (T2) using a paper or e-version. Participants and clinicians provided feedback on the data collection process. Clinicians completed the CRPS severity score at T1 and optionally, at T2. Ethical approval was obtained at each international centre.
Results: ninety-eight adults were recruited (female n=66; mean age 46.6 years, range 19-89), of whom 32% chose to receive the T2 questionnaire in an electronic format. Fifty-five participants completed both T1 and T2. Eighteen participants and nine clinicians provided feedback on their data collection experience.
Conclusion: this study confirmed the questionnaire core outcome data are feasible and practicable to collect in clinical practice. The electronic data management system provided a robust means of collecting and managing the data across an international population. The findings have informed the final data collection tools and processes which will comprise the first international, clinical research registry and data bank for CRPS.
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More information
Accepted/In Press date: 2023
e-pub ahead of print date: 10 July 2023
Published date: October 2023
Additional Information:
Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Swiss National Accident Insurance Fund (SUVA).We would like to extend our thanks to the Swiss National Accident Insurance Fund (SUVA) who funded this study. JX’s research is supported by US NIH K08CA228039, VeloSano at Cleveland Clinic, and Steve & Melody Golding Foundation. We would like to thank all those with CRPS who participated in the study, and our international research teams who remained committed to the study, throughout challenging global times.
Funding Information:
We would like to extend our thanks to the Swiss National Accident Insurance Fund (SUVA) who funded this study. JX’s research is supported by US NIH K08CA228039, VeloSano at Cleveland Clinic, and Steve & Melody Golding Foundation. We would like to thank all those with CRPS who participated in the study, and our international research teams who remained committed to the study, throughout challenging global times.
Funding Information:
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: section rather than here in the conflict of interest. The text is slightly amended as the request of co-author JX. Thank you JX’s research is supported by US NIH K08CA228039, VeloSano at Cleveland Clinic, and Steve & Melody Golding Foundation. SG was a National Institute for Health Research (NIHR) Senior Nurse Leader whilst the study was conducted. The views expressed in this article are those of SG and not necessarily those of the NIHR, or the UK Department of Health and Social Care. All other authors declare they have no conflict of interest.
Publisher Copyright:
© The Author(s) 2023.
Keywords:
Complex regional pain syndrome, core measurement set, feasibility study, international registry, pain measurement
Identifiers
Local EPrints ID: 482834
URI: http://eprints.soton.ac.uk/id/eprint/482834
ISSN: 2049-4637
PURE UUID: dc9d28a6-2471-412b-9e1a-660108db5005
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Date deposited: 13 Oct 2023 16:32
Last modified: 17 Mar 2024 04:50
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Contributors
Author:
Sharon Grieve
Author:
Florian Brunner
Author:
Danylo Cabral
Author:
Robyn Connett
Author:
Hitoshi Hirata
Author:
Norimasa Iwasaki
Author:
Yasunobu Nakagawa
Author:
Afrin Sagir
Author:
Jean-Jacques Vatine
Author:
Nicole Vaughan-Spickers
Author:
Jijun Xu
Author:
Lisa Buckle
Author:
Candida McCabe
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