[Zurück zur Trefferliste]

VAPAIN - Validation and Application of a patient relevant core outcome set to assess effectiveness of multimodal PAIN therapy

 

Projektkennung VfD_VAPAIN_14_003470
Laufzeit von 01/2014 bis 12/2016
Status des Projekts laufend

 

Projektbeschreibung

Fragestellung(en) Step 1: Aim: Development and Recommendation of a preliminary core set of outcome domains
Step 2: Aim: Recommendation of candidate instruments to measure the preliminary core outcome domains from step 1
Step 3: Aim: Validation of a preliminary COS of measurement instruments to assess effectiveness of MPT/FR in chronic pain from step 2
Step 4: Aim: Finalization of the COS of effectiveness and daily recordkeeping in MPT/FR by consensus
Hintergrund / Ziele VAPAIN (Validation and Application of a patient relevant core outcome set to assess effectiveness of multimodal PAIN therapy) is funded by the German Federal Ministry of Education and Research (BMBF 01GY1326). The project is a co-operation between the University PainCenter and the Center for Evidence-Based Healthcare.

The overall aim of this study is to develop an evidence-based consensus on a COS measurement tool for MPT/FR to assess the effectiveness of interventions and to be used in daily recordkeeping.
To achieve the overall aim, the following specific objectives need to be answered successively:
1. Development and recommendation of a preliminary core set of outcome domains for effectiveness studies and daily recordkeeping,
2. Definition of specific reliable and valid instruments to measure the preliminary developed and recommended domains for evaluation of the effectiveness of MPT/FR,
3. Validating the preliminary core set of outcome domains and core set of measurement instruments in case of lacking information concerning psychometric properties in a multicenter study in the setting of MPT/FR,
4. Finalization of core set of outcome domains inclusive instruments and additional evaluation of further questions.

According to the German Pain Society ‘interdisciplinary multimodal pain therapy’ is defined as the simultaneous, contextual, temporal and coordinated, comprehensive strategy to treat chronic pain patients integrating different somatic, physical as well as psychological treatment approaches with identical and within the therapeutic team consensual therapeutic aims (Arnold et al., 2009). The standardized treatment is performed by a team of physicians of different disciplines, psychotherapists or clinical psychologists and other disciplines such as physiotherapists, ergotherapists, and others. The objective and subjective restoration with increased controllability and the sense of competence of the patients is the central aim of this resource-orientated approach (Arnold et al., 2009). This definition has been developed historically out of and is therefore similar to the approach of functional restoration by Mayer and Gatchel (1988).

The multidisciplinary pain therapy (MPT; including approaches of functional restoration FR) of chronic pain applies to a complex condition and simultaneously is provided under different circumstances and settings. Measuring the effectiveness of MPT/FR is therefore one of the most fundamental challenges communicating clinically relevant information.

The assessment of the effectiveness of multidisciplinary pain therapy in clinical trials and in routine care is rather heterogeneous at present. This leads to the situation, that studies and treatments cannot be reliably compared according to the principles of evidence based medicine. This constitutes an important barrier in clinical decision making. Recent initiatives, such as IMMPACT, focused mainly on clinical trials only. Additionally MPT/FR with its specific therapy aims seems to need other outcomes as medical trials. Over the last decades there has been much research in relevant biopsychosocial concepts on chronic pain which have not been considered in other initiatives so far and might be highly relevant in MPT/FR.

The link to VAPAIN is http://www.uniklinikum-dresden.de/das-klinikum/universitatscentren/usc/studien-projekte/vapain/vapain_eng
Methodik Given the complexity of the four specific aims a multi-step process using a multi-method-approach is necessary.

Step 1: Aim: Development and Recommendation of a preliminary core set of outcome domains
To achieve this aim a systematic review on effectiveness studies and a subsequent online survey and presence meeting will be conducted.
Systematic Review on published outcomes in effectiveness studies of MPT/FR in chronic pain
To systematically search for incorporated domains in randomized controlled trials (RCTs) and longitudinal non-randomized studies in the matter of MPT/FR we will search in Medline, EMBASE, and AMED. Screening of titles/abstracts as well as eligible full texts will be done independently by two researchers. All disagreements will be re¬solved in consensus meetings. Since this review will focus on broad information of used and published outcome domains in effectiveness studies of MPT/FR in chronic pain, critical appraisal of study quality is not intended.
Online Consensus on preliminary COS to assess effectiveness of MPT/FR in chronic pain
In relation to the derived literature based outcome domains, an online survey will be conducted to recommend important outcome domains for a COS. In order to allow multi-professional collaboration and to represent different stakeholder groups, 25 experts with methodological, clinical medical, functional and psychological expertise as well as patient representatives will participate.
Output of Step 1
The output of this consensus part is a preliminary consensus of a core set of outcome domains for MPT/FR in a) effectiveness studies and b) daily recordkeeping.

Step 2: Aim: Recommendation of candidate instruments to measure the preliminary core outcome domains from step 1
Methods to Step 2
Systematic reviews on measurement properties of preliminary COS
The objectives of this review are to systematically assess psychometric properties of instruments to measure the previously defined core outcome domains. Articles in which a relevant scale depending on the particular domain (see step 1) was published first (“inauguration articles”) and articles which subsequently investigate the measurement properties of relevant scales are eligible. The systematic literature search will be performed in Medline and EMBASE. Screening of titles/abstracts as well as eligible full texts will be done independently by at least two reviewers. All disagreements will be resolved in consensus meetings. The COSMIN checklist will be used to evaluate the methodological quality of included studies.
Presence Meeting
A consensus conference for group discussion and final voting will be scheduled in Dresden (Germany) and all participants of step 1 will be invited. In this final round, according to the results of the online survey, the experts vote for domains being part of the COS. Consensus that a domain/instrument is important for MPT/FR will be defined by at least 70% of all members voting “yes”. Discussion of results will be moderated by an experienced moderator. Further resulting from the systematic reviews from step 2, the experts will be asked to discuss and recommend particular instruments for specific domains. At the end of the meeting, recommendations on a feasible amount of domains and specific instruments to evaluate effectiveness/daily recordkeeping of MPT/FR are expected. Additionally, recommendations on important gaps considering psychometric properties of instruments and questions to be clarified by the following study/further research will be given.
Output of Step 2
Output of step 2 is a consensus on core domains and instruments. We further expect the nomination of candidate instruments which shall be addressed for further questions of research to assess their psychometric properties during the next phase of the study - the validation of the set of instruments in a multicenter study.

Step 3: Aim: Validation of a preliminary COS of measurement instruments to assess effectiveness of MPT/FR in chronic pain from step 2
Methods to step 3
Prospective multicenter study in four German comprehensive pain centers and focus groups
The core set of outcome domains and measurement instruments recommended by the final voting of expert panel as described at the end of step 2 will be applied and further investigated according to validity, reliability, responsiveness and interpretability as highly recommended psychometric properties by COSMIN in the setting of MPT/FR. Instruments lacking of at least one of the relevant psychometric properties or which have not been investigated in the setting of MPT/FR will be taken into step 3. To ensure complete content validity additionally to the quantitative part of validation via questionnaire a qualitative part will be conducted.
All consecutive patients eligible (inclusion criteria: age = 18 years, chronic permanent or recurrent pain for at least 3 months, medium or high impairment of physical and psychological functioning, sufficient capability to tolerate physical activation, and sufficient skills in German language) for MPT/FR will be asked to participate in the prospective cohort study at admission in one of the four participating centers (Mainz, Erlangen, Dresden, Leipzig). Data collection by means of patient and physician questionnaires will be done at baseline (admission), discharge, booster (a repetition therapy after some weeks off therapy) and at 9 months follow-up. The patients’ questionnaire will cover information on socio-demographic characteristics and the patient-reported outcome measures as defined in step 1 and step 2 of the project. The physicians’ questionnaire will cover information on physical, functional and psychological status of the patient, the patients’ history of chronic pain and previous and current treatments.
In accordance with the recommendations of the COSMIN group, the following properties of outcome measures will be considered in the analysis: validation (content), reliability (internal consistency, test-retest), interpretability, and responsiveness.
Qualitative validation study
Because of the nature of quantitative approaches regarding patient´s perspective on content validity and usability of the instruments there will be an additional qualitative validation realized by focus groups (moderated group discussions, concerning issues of content validity, responsiveness and usability of candidate/core instruments in the presented study). There will be eight focus groups (two in each of the participating centers) all consisting of 8 patients, a moderator and a transcript writer. In order to make the different focus groups comparable the moderation is guided by preassigned central questions. The output of the discussion will be visualized on presentation boards and summarized in written forms. Both steps of documentation will be validated by the members of the focus group to ensure internal validity. The results of these groups will support interpretability of the results of the quantitative study and close the gap between clinicians’ and patients’ perspectives.
Output of step 3
Evidence of validity and reliability of core set of outcome domains and measurement instruments in MPT/FR will be the result of step 3. New issues of use and psychometric properties of measurement instruments will be identified and shall be addressed in the following step 4, the finalization of the core outcome set of domains and measurement instruments. The perspective of patients will be included to ensure overlap between experts’ and patients’ opinion about important outcome measurement of effectiveness of MPT/FR.

Step 4: Aim: Finalization of the COS of effectiveness and daily recordkeeping in MPT/FR by consensus
After completing the study and assembling of all concerning results a finalization by the panel members will be held to approve the preliminary COS or/and to develop new questions on specific issues arising from the process.
Datenbasis Primärdaten
   Befragung online  (Stichprobengröße: 25)
   Interview (Face to face)  (Stichprobengröße: k.A.)
   Gruppendiskussion/Fokusgruppe  (Stichprobengröße: 25)
   Beobachtungen  (Stichprobengröße: 270)
Studiendesign Kohortenstudie (prospektiv)
Literaturarbeit
   Systematische Literaturrecherche
Untersuchte Geschlechter weiblich und männlich
Untersuchte Altersgruppen von 18 bis 99 Jahre
Ergebnisse --

Forschende und kooperierende Einrichtungen

Projektverantwortliche

Förderung

Veröffentlichungen

Schlagwörter

 

Stand: 15.07.2015