Developing a core outcome domain set to assessing effectiveness of interdisciplinary multimodal pain therapy: the VAPAIN consensus statement on core outcome domains

Abstract

Interdisciplinary multimodal pain therapy (IMPT) is a biopsychosocial treatment approach for patients with chronic pain that comprises at least psychological and physiotherapeutic interventions. Core outcome sets (COSs) are currently developed in different medical fields to standardize and improve the selection of outcome domains, and measurement instruments in clinical trials, to make trial results meaningful, to pool trial results, and to allow indirect comparison between interventions. The objective of this study was to develop a COS of patient-relevant outcome domains for chronic pain in IMPT clinical trials. An international, multiprofessional panel (patient representatives [n = 5], physicians specialized in pain medicine [n = 5], physiotherapists [n = 5], clinical psychologists [n = 5], and methodological researchers [n = 5]) was recruited for a 3-stage consensus study, which consisted of a mixed-method approach comprising an exploratory systematic review, a preparing online survey to identify important outcome domains, a face-to-face consensus meeting to agree on COS domains, and a second online survey (Delphi) establishing agreement on definitions for the domains included. The panel agreed on the following 8 domains to be included into the COS for IMPT: pain intensity, pain frequency, physical activity, emotional wellbeing, satisfaction with social roles and activities, productivity (paid and unpaid, at home and at work, inclusive presentism and absenteeism), health-related quality of life, and patient's perception of treatment goal achievement. The complexity of chronic pain in a biopsychosocial context is reflected in the current recommendation and includes physical, mental, and social outcomes. In a subsequent step, measurement instruments will be identified via systematic reviews.

Long-term outcomes of multimodal rehabilitation in primary care for patients with chronic pain

“…The questionnaire included demographics and questions regarding pain duration, number of pain sites and pain intensity as well as education, country of birth, work situation, sick leave and prognosis of return to work. Most of the included instruments covered the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) core outcome domains for the treatment of patients with chronic pain (13) and validation and application of a patient-relevant core set of outcome domains to assess multimodal pain therapy (VAPAIN) (14). In this study, data at the start of the study and at 1-year follow-up were used.…”

“…The patient reported the number of sites with pain on the left side of the body (n = 18) and on the right side of the body (n = 18); a total of 36 locations. These pain sites were: (1) head/face, (2) neck, (3) shoulder, (4) upper arm, (5) elbow, (6) forearm, (7) hand, (8) anterior aspect of chest, (9) lateral aspect of chest, (10) belly, (11) sexual organs, (12) upper back, (13) lower back, (14) hip/gluteal area, (15) thigh, (16) knee, (17) shank, and (18) foot.…”

Maintenance of quality of life improvement for patients with chronic pain and obesity after interdisciplinary multimodal pain rehabilitation – A study using the Swedish Quality Registry for Pain Rehabilitation

“…According to the VAPAIN initiative, Health-Related Quality of Life (HRQoL) is one of the main outcome domains in Interdisciplinary Multimodal Pain Rehabilitation (IMMPR) (Kaiser et al, 2018). Prior studies have linked HRQoL both with obesity and pain (Arranz et al, 2014;Barofsky, Fontaine, & Cheskin, 1997;Heo, Allison, Faith, Zhu, & Fontaine, 2003).…”

Access to Pain Management Programs: A Multifactorial Analysis of the Pathways of Care for Chronic Pain Patients in the University Clinic Erlangen

“…It is stated, that severely depressed and disabled patients suffering from chronic pain should be allocated to more intense programs while less depressed and less disabled patients profit just as well in less intensive programs and should therefore be treated less extensively on the first hand. In the consensus statement of the German VAPAIN project it was also stated, that specific treatment for specific subgroups of patients should be provided and restricted applications of pain management programs for patients with lower levels of chronicity would be resource-saving [53]. In the light of the still existing supply bottleneck in the treatment of patients with chronic pain and with increasing knowledge about predictors of therapy success of different patient characteristics it seems reasonable to preferably include those patients in intense programs who are likely to benefit.…”

“…On the other hand, to be able to investigate the pathways of care, multi-center data about allocation, utilization and success of treatment in the different pathways of care would be desirable. In particular, further need for research exists regarding operationalizing success measurement and predictors of success which should optimise the allocation decision (see VAPAIN-Projekt, [53,54]).…”