Nicole Vaughan-Spickers
A multi-centre study to explore the feasibility and acceptability of collecting data for complex regional pain syndrome clinical studies using a core measurement set: Study protocol
Vaughan-Spickers, Nicole; Vatine, Jean Jacques; Hirata, Hitoshi; Grieve, Sharon; Brunner, Florian; Buckle, Lisa; Gobeil, Francois; Iwasaki, Norimasa; Moseley, Lorimer; Sousa, Gudson; Vatine, Jean?Jacques; Vaughan?Spickers, Nicole; Xu, Jijun; McCabe, Candida
Authors
Jean Jacques Vatine
Hitoshi Hirata
Sharon Grieve
Florian Brunner
Lisa Buckle
Francois Gobeil
Norimasa Iwasaki
Lorimer Moseley
Gudson Sousa
Jean?Jacques Vatine
Nicole Vaughan?Spickers
Jijun Xu
Candy McCabe Candy.Mccabe@uwe.ac.uk
Professor of Clinical Research and Practice
Abstract
© 2019 John Wiley & Sons, Ltd. Objectives: This international, multicentre study will inform the final data collection tools and processes which will comprise the first international, clinical research registry for complex regional pain syndrome (CRPS). This study will: (a) test the feasibility and acceptability of collecting outcome measurement data using a patient reported, questionnaire core measurement set (COMPACT [Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies]); and (b) test and refine an electronic data management system to collect and manage the data. Methods: A maximum of 240 adults, meeting the Budapest diagnostic clinical criteria for CRPS type I or II, will be recruited across eight countries. The COMPACT questionnaire will be completed on two occasions: at baseline (T1) and 6months later (T2). At T2, participants will choose to complete COMPACT using a paper or electronic version. Participants will be asked to feed back on their experience of completing COMPACT via a questionnaire. A separate questionnaire will ask clinicians to feed back their experience of data collection. Analysis: The study is not aiming to derive statistically significant data but to ascertain the practicalities of collecting data, using the COMPACT questionnaire set, across a range of different cultures and populations. At the end of the study, a single workshop will be convened to review the findings and agree the final documents and processes for the international registry.
Journal Article Type | Article |
---|---|
Acceptance Date | May 4, 2019 |
Online Publication Date | Jul 11, 2019 |
Publication Date | Sep 1, 2019 |
Deposit Date | Aug 30, 2019 |
Publicly Available Date | Jul 12, 2020 |
Journal | Musculoskeletal Care |
Print ISSN | 1478-2189 |
Electronic ISSN | 1557-0681 |
Publisher | Wiley |
Peer Reviewed | Peer Reviewed |
DOI | https://doi.org/10.1002/msc.1408 |
Keywords | Complex Regional Pain Syndrome; core measurement set; registry; clinical studies; patient reported outcomes. |
Public URL | https://uwe-repository.worktribe.com/output/2611467 |
Publisher URL | https://onlinelibrary.wiley.com/doi/full/10.1002/msc.1408 |
Additional Information | Received: 2019-04-30; Accepted: 2019-05-04; Published: 2019-07-11 |
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A multi-centre study to explore the feasibility and acceptability of collecting data for Complex Regional Pain Syndrome clinical studies using a core measurement set. Study protocol
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Copyright Statement
This is the peer reviewed version of the following article: Grieve S, Brunner F, Buckle L, et al. A multi‐centre study to explore the feasibility and acceptability of collecting data for complex regional pain syndrome clinical studies using a core measurement set: Study protocol. Musculoskeletal Care. 2019;1–8, which has been published in final form at https://doi.org/10.1002/msc.1408. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving
Fig 1. Trajectory Of Study Protocol (1)
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Table 1. PROMS Included In COMPACT (1)
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Main Document (1)
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Copyright Statement
This is the peer reviewed version of the following article: Grieve S, Brunner F, Buckle L, et al. A multi‐centre study to explore the feasibility and acceptability of collecting data for complex regional pain syndrome clinical studies using a core measurement set: Study protocol. Musculoskeletal Care. 2019;1–8, which has been published in final form at https://doi.org/10.1002/msc.1408. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving
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