PROMPT NIT-1 v1
Research type
Research Study
Full title
Providing standardized consented PROMs (Patient Reported Outcome Measures) for improving pain treatment. A multicenter, non-interventional, prospective observational study
IRAS ID
269694
Contact name
Theresa Wodehouse
Contact email
Sponsor organisation
Jena University Hospital
Clinicaltrials.gov Identifier
NCT 3834922, clinicaltrials.gov Identifier; 777500, Innovative Medicines Initiative 2 Joint Undertaking, GA No.
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
PROMPT (Providing Standardized Consented PROMs for Improving Pain Treatment) is one of three subprojects within the IMI-2 JU project IMI-PainCare (PROMPT, BioPain, TRiPP). PROMPT seeks to improve management of acute and chronic postoperative pain by identifying a core set of PROMs (standardized patient reported outcome measures) which are predictive indicators of treatment success in clinical practice and implementing their standard use in randomized controlled trials (RCTs). \nThese will address pain intensities as well as the functional consequences of pain for individuals, and identify patients at risk of experiencing chronification of acute post-operative pain. The results will help health care professionals to individualize pain management, and thus improve the quality of life of pain patients. The quality of research will be improved, since the same outcome measures will be harmonized, and accelerate drug development. Furthermore, the correlation of baseline characteristics and a selection of PROMs for specific chronic pain conditions will identify which parameter(s) most reliably predict treatment success. \nIn order to reach this objective, a non-interventional prospective data collection aiming at reaching a consensus on a core set of PROMs which reliably predict and/or measure success in acute and chronic pain treatments in real life conditions and identifying predictors for chronification of postoperative pain will be conducted (PROMPT NIT-1). Aim of the data collection is to evaluate the abilities of certain PROMs in assessing acute post-surgical pain outcomes in daily routine care of patients after four different surgical procedures: (total knee replacement, breast surgery, sternotomy and surgery related to endometriosis), and to validate selected risk factors for chronification prospectively.
REC name
Wales REC 4
REC reference
19/WA/0274
Date of REC Opinion
9 Oct 2019
REC opinion
Unfavourable Opinion