Identifying the core clinical outcomes for measurement in future complex regional pain syndrome (CRPS) clinical studies
| ISRCTN | ISRCTN56474274 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56474274 |
| Secondary identifying numbers | Protocol v1 25.2.19 |
- Submission date
- 03/04/2019
- Registration date
- 01/05/2019
- Last edited
- 10/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Complex Regional Pain Syndrome (CRPS) is a chronic pain condition that has severe negative impacts on patients' quality of life. It is difficult to treat and is not well understood. Whilst there has been success in standardising diagnosis of the condition, it has been difficult to bring together findings from research studies, as researchers and clinicians may not always measure the same features. This means that it has not been possible to combine data from different studies and therefore evidence about the condition is often limited to findings from studies with small numbers of patients. We now need to create a recommended set of those features that all CRPS research studies should measure in the future. This will enable us to pool findings from different studies and, from this wider evidence, understand more about the causes, course and best treatment approaches for CRPS. An international group of patients, clinicians, researchers and industry representatives has already agreed a minimum set (COMPACT-Q) of questionnaires that patients complete to tell researchers about their CRPS. This is currently being tested for use in future CRPS clinical studies in adults. The aim of this study is to define a minimum set of the features that clinicians (e.g. doctors, physiotherapists, occupational therapists) measure or assess in CRPS research studies. Once this core "clinical" set has been defined, the existing systems for collecting and storing this information will be modified, and researchers around the globe will be encouraged to use the new minimum clinical outcome set.
Who can participate?
Clinician, academic, industry representative or patient representative with expertise/experience in Complex Regional Pain Syndrome, members of the International Association for the Study of Pain Special Interest Group for Complex Regional Pain Syndrome, members of the Complex Regional Pain Syndrome International Research Consortium, or members of the COMPACT consortium.
What does the study involve?
The participants review a list of outcomes currently used in CRPS research studies, and rate these for relevance for researchers who want to answer the question "What is the clinical presentation and course of CRPS, and what factors influence it?". The findings are analysed and those outcomes with the highest ratings are considered at a workshop of experts for inclusion in a core outcome set to be recommended for use in all future CRPS research studies.
What are the possible benefits and risks of participating?
This study will not benefit participants directly. However, the results will help develop a standard core set of clinical outcomes for use in future CRPS research studies. In the long term this will help researchers answer some of the important questions about CRPS. There are no risks in taking part in the study.
Where is the study run from?
Royal United Hospitals Bath NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
September 2018 to April 2020
Who is funding the study?
Reflex Sympathetic Dystrophy Syndrome Association (USA)
Who is the main contact?
Dr Alison Llewellyn
Alison.Llewellyn@uwe.ac.uk
Contact information
Scientific
University of the West of England
Glenside Campus
Blackberry Hill
Bristol
BS16 1DD
United Kingdom
 ORCID ID |
0000-0002-8769-832X |
|---|---|
| Phone | +44 (0)117 3287495 |
| Alison.Llewellyn@uwe.ac.uk |
Study information
| Study design | International e-Delphi survey and consensus workshop |
|---|---|
| Primary study design | Observational |
| Secondary study design | Expert/stakeholder opinion to define core outcome measures |
| Study setting(s) | Internet/virtual |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | COMPACT-C: An e-Delphi study to define internationally agreed core clinical outcome measures for Complex Regional Pain Syndrome clinical studies |
| Study acronym | COMPACT-C |
| Study objectives | This study is a consensus approach to defining a minimum core set of clinical outcome measures (COMPACT-C) that will complement the current COMPACT patient-reported outcome measurement set. Collecting international data using these core measurement sets will enable researchers to answer the research question: What is the clinical presentation and course of CRPS, and what factors influence it? |
| Ethics approval(s) | Approved 29/03/2019, Faculty of Health and Applied Sciences Research Ethics Committee at the University of the West of England (Dr Julie Woodley, Chair of Faculty of Health and Applied Sciences Research Ethics Committee, Glenside Campus, Blackberry Hill, Bristol, UK BS16 1DD; Tel: +44 (0)117 32 81170; Email: researchethics@uwe.ac.uk), ref: HAS.19.02.142 |
| Health condition(s) or problem(s) studied | Complex regional pain syndrome |
| Intervention | The study methodology is an electronic-Delphi study, supported by face-to-face workshops. The stages are as follows: 1. Workshop 1: to consider expert opinion and the results of a systematic literature review in order to identify a full list of clinical outcome measures used in complex regional pain syndrome clinical studies. 2. Electronic Delphi Round 1: to survey clinicians, academics and others working in the field of CRPS. Respondents will be asked to review the list of clinical outcomes arising from Workshop 1 and to rate the scientific relevance of each outcome on a 9-point Likert scale, in relation to the question "What is the clinical presentation and course of CRPS, and what factors influence it?". Responses will be collated to create Round 2. 3. Electronic Delphi Round 2: Respondents who completed Round 1 will be presented with a personalised survey comprising the individual ratings they provided in Round 1 and the group median rating for each outcome. Any free text comments provided in Round 1 will also be displayed in an anonymised manner. Participants will be asked to re-rate each outcome in light of this information. 4. Workshop 2; to consider those outcomes rated consistently most highly in the electronic Delphi Round 2 and to agree the draft ‘core clinical outcome measurement set’. 5. Experts in the field of CRPS will consider any practical limitations to the final selected outcomes (financial, equipment or time restrictions) and agree the final 'core clinical outcome measurement set'. They will also ensure this can be appropriately presented and supported on the COMPACT data management system. |
| Intervention type | Other |
| Primary outcome measure | Identification of a core clinical outcome measurement set, agreed via collecting ratings of the relevance of clinical outcomes to the question "What is the clinical presentation and course of CRPS, and what factors influence it?". This method uses a Likert 1-9 rating scale at two timepoints: baseline and following feedback of baseline median group ratings |
| Secondary outcome measures | Modification of the existing COMPACT data management system is agreed by expert opinion, so that it can collect and store core outcome data from future clinical studies |
| Overall study start date | 01/09/2018 |
| Completion date | 30/04/2020 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Min 50, max 300 |
| Total final enrolment | 74 |
| Key inclusion criteria | 1. Participants must be a clinician, academic, industry representative or patient representative with expertise/experience in Complex Regional Pain Syndrome 2. Participants may be members of the International Association for the Study of Pain Special Interest Group for Complex Regional Pain Syndrome, members of the Complex Regional Pain Syndrome International Research Consortium, or members of the COMPACT consortium. |
| Key exclusion criteria | Not a clinician/academic/researcher working in the field of Complex Regional Pain Syndrome |
| Date of first enrolment | 11/04/2019 |
| Date of final enrolment | 22/05/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bath
BA1 3NG
United Kingdom
Sponsor information
Hospital/treatment centre
Coombe Park
Bath
BA1 3NG
England
United Kingdom
| Phone | +44 (0)1225 465479 |
|---|---|
| Jane.carter14@nhs.net | |
| Website | http://www.ruh.nhs.uk |
"ROR" |
https://ror.org/058x7dy48 |
Funders
Funder type
Other
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- RSDSA
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/11/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | The researchers plan to publish findings and recommendations in a peer-reviewed scientific journal with an intent to publish date of around one year after the overall study end date. They will submit one or more abstracts for poster presentation at a scientific conference. They will publish the results on relevant websites and include a lay summary where applicable. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository. The repository is within the secure electronic environment of the University of the West of England and/or on secure servers at the Royal United Hospitals Bath NHS Foundation Trust. Authorised members of the UK study team will have access to the data. Anonymised data will be made available to wider (non-UK) team members at the discretion and invitation of the study CI, or their appointed representative, and under the terms of a collaborative agreement. Data may also be looked at by representatives of regulatory authorities solely for the purpose of checking that the study is being carried out correctly. Study data will be held for a minimum of five years and may be re-used for sub-group analyses by the study team within this period. Personal data will be held for two years after the study is finished in order to address any queries that might arise during the dissemination of the work, but will not be shared outside the UK study research team. Informed consent will be obtained from all electronic Delphi participants prior to data collection. All data will be held according to Good Clinical Practice and data protection requirements including the General Data Protection Regulation (GDPR), and the Data Protection Act (2018) in the UK. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 04/07/2022 | 01/08/2022 | Yes | No | |
| Protocol file | version 1 | 25/02/2019 | 10/10/2022 | No | No |
Additional files
Editorial Notes
10/10/2022: Protocol file uploaded.
01/08/2022: Publication reference added.
14/09/2021: The intention to publish date has been changed from 30/09/2021 to 30/11/2021.
14/06/2021: The intention to publish date was changed from 30/04/2021 to 30/09/2021.
22/10/2020: Total final enrolment number added.
11/06/2019: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/03/2018 to 11/04/2019.
2. The recruitment end date was changed from 01/04/2018 to 22/05/2019.
09/04/2019: Trial's existence confirmed by research ethics committee.
