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 recommending their standard use in future randomized controlled research trials (RCTs). The PROMs will address pain intensity as well as the functional consequences of acute postoperative pain, and identify patients at risk of developing chronic pain after surgery. The results of this study are expected to improve the quality of life of patients who undergo surgery and to help health care professionals to individualize postoperative pain management. With the development of validated PROMs that are sensitive to change in postoperative treatment of pain the quality of future research can be improved, since the same outcome measures will be used in this area of clinical research. These PROMs should be used in the development of new techniques and drugs in this field. In 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
London - Chelsea Research Ethics Committee
REC reference
19/LO/1929
Date of REC Opinion
7 Feb 2020
REC opinion
Further Information Favourable Opinion