Benutzerspezifische Werkzeuge

Study and Results

The VAPAIN initiative
Registration of study protocol and publications
The study protocol was published a priori [Kaiser et al., 2015].
VAPAIN is registered in the Core Outcome Measures in Effectiveness Trials (COMET) database.
Ethical approval was obtained from the Ethical Committee of the Medical Faculty of the Technical University Dresden (EK 105032015).
Results of the systematic reviews are published
Deckert et al., EJP 2015
Results of the consensus process are submitted in ARD.

The VAPAIN panel

Panel members were representative of relevant stakeholder groups of IMPT in clinical research and/or daily practice: patients, physicians specialized in pain medicine, physiotherapists, clinical psychologists, and methodological researchers. Panel members were experienced in their fields (clinicians were supposed to be at least acquainted with IMPT and its therapeutic components), were nominated by international organizations, and scientific associations related to pain and/or chronic pain. N=25 representatives of these stakeholder groups took part at the panel meeting and throughout the process.

  • Table of the panel members [folgt]

Project schedule

The design of the project orientated on HOME Roadmap [Schmitt et al., 2011]. Originally it was intended to find consensus on COS for effectiveness/efficacy studies (ES) and for daily record keeping (DRK).

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Figure 1: Steps of VAPAIN (adapted from Kaiser et al. ARD (submitted)

Results

Systematic review (January-March 2014)

A systematic review was conducted to prepare a list of the most reported outcome-domains for chronic pain in the context of IMPT [Deckert 2016]. Outcomes found in at least 10% of included studies were selected and preclassified into 19 different areas and domains according to the Patient-Reported Outcomes Measurement Information System (PROMIS) (applied PROMIS-model during VAPAIN consensus process).

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Figure 5: PROMIS-model including subdomains/domains based on the results of the online survey (for definitions of terms please refer to the glossary)

 

Online survey domains (step 1, 1.1-1.2; April-June 2014)

The panel was originally addressed by online survey to decide for COS for effectiveness studies and daily record keeping and to add relevant outcome-domains not found among the 19 pre-selected domains. The pre-selected domains were provided with definitions according to literature. Unfortunately, even after round 2 no tendency of consensus was observed, so third round was skipped and panel members were invited to face-to-face-meeting for final voting.

Response rates for round 1 and round 2 were 100% (n=25) and 88% (n=22), respectively. Panel members decided that the COS domains for efficacy/effectiveness studies should contain a minimum of 4, and a maximum of 9 domains. For daily record keeping a minimum of 3 and a maximum of 6 domains were considered appropriate. The wide range of ratings observed during both rounds for most of the domains, with a median of ≥7 ES as well as DRS, indicated different perspectives among the panel members on what should be measured.

Results from online survey round 2 (step 1, 1.2)

Face-to-face meeting (step 1, 1.3; November 2014)

Panel members received a booklet with information regarding the development of COS, VAPAIN, and additional publications for information about domains. Patient representatives attended an additional briefing before the consensus meeting, where they were introduced to COSs and procedures for the meeting. A glossary providing definitions of basic terms were sent to the participants in advance.

The consensus statement as the results from this meeting has been submitted so far (Kaiser et al. ARD submitted).

COS for efficacy/effectiveness studies (ES) in IMPT

Results of the small group voting

In summary, patient representatives rated 14 outcome-domains as relevant for a COS for efficacy/effectiveness studies in IMPT. There were large differences between stakeholder groups, most notable between patient representatives and clinical psychologists; 50% (n=7) of the domains voted by the patients as “critical”, were voted for exclusion by the clinical psychologists. For pain intensity and pain frequency there was substantial disagreement due to some participants arguing that both outcome-domains should not be part of the COS in chronic pain since there is not much change during therapy. The sole agreement throughout all groups was observed for health-related quality of life.

Results from the plenary voting

The following eight domains were voted for inclusion by at least 70% of all meeting participants to be included for efficacy/effectiveness studies: 1) pain intensity, 2) pain frequency, 3) physical activity, 4) emotional wellbeing, 5) satisfaction with social roles and activities, 6) productivity (paid and unpaid, at home and at work, including presentism and absenteeism), 7) health-related quality of life, 8) and patient’s perception of treatment goal achievement. Only pain intensity, pain frequency, and health related quality of life were adopted from the previous online survey, the other domains emerged from debating preselected and provided domains. A short summary of minutes from the face-to-face meeting is available via online supplement.

By reference to OMERACT (Outcome Measures in Rheumatology) recommendations [Boers et al., 2014], the panel recommended withdrawal from therapy/side effects as critical domains.

COS for daily record keeping (DRK) in IMPT

The panel discussed the importance of daily record keeping COSs, referring particularly to the purposes of a COS for daily records, and different national requirements. No agreement was achieved, and the panel decided to primarily focus on the COS in efficacy/effectiveness studies, adjourning the debate about a COS for daily record keeping.

Online Surveys “definitions of domains” (step 2, 2.1-2.3; March-October 2015)

For all of the consented domains officially published and consented definitions if available were presented to the panel. Supplementary notes from the meeting were provided for a consistent awareness of the previous discussion. Aim was to achieve consensus on working definitions for all subsequent steps (systematic reviews on measurement instruments, step 3)

During online survey round 2.1-2.3 (fig. 1, table 5), panel members were provided with possible definitions (step 2, presence meeting). For emotional wellbeing, panel members received three possible definitions; the wording of patient´s perception of treatment goal achievement was discussed at length. Response rate of the four rounds (three to discuss, and vote, for domain definitions and an additional round to clarify the definitions of emotional wellbeing and patient`s perception of treatment goal achievement) ranged from 100% (2.1, 2.3) to 80% (2.2, 2.2-1). Final results are presented in table 5. For all outcome-domain definitions but one (pain frequency) a consensus was achieved.

Next steps (step 3 and 4)

Systematic reviews (step 3): Work in progress

Validation process (step 4): For pain intensity measurement instruments the validation is still work in progress (status: data sampling)

References

Boers M, Kirwan JR, Wells G, Beaton D, Gossec L, d'Agostino MA, et al. Developing Core Outcome Measurement Sets for Clinical Trials: OMERACT Filter 2.0. J Clin Epidemiol. 2014.
Deckert S, Kaiser U, Kopkow C et al. (2016) A systematic review of the outcomes reported in multimodal pain therapy for chronic pain. Eur J Pain 20 (1): 51-63
Kaiser U, Kopkow C, Deckert S et al. (submitted) Developing a Core Outcome-domain Set to assessing Effectiveness of Interdisciplinary Multimodal Pain Therapy - The VAPAIN consensus statement on core outcome-domains. ARD
Kaiser U, Kopkow C, Deckert S et al. (2015) Validation and application of a core set of patient-relevant outcome-domains to assess the effectiveness of multimodal pain therapy (VAPAIN) - a study protocol. BMJ Open 5: e008146   doi: 10.1136/bmjopen-2015-008146
Schmitt J, Apfelbacher C, Spuls PI et al (2014) The Harmonizing Outcome Measures for Eczema (HOME) Roadmap: A Methodological Framework to Develop Core Outcome Sets of Outcome Measurements in Dermatology. J Invest Dermatol 135:24-30