Validation and application of a core set of patient-relevant outcome domains to assess the effectiveness of multimodal pain therapy (VAPAIN): a study protocol.

INTRODUCTION: Multimodal pain therapy (MPT) has been established accounting for biopsychosocial consideration in diagnostic and therapy. MPT seems to be effective, but comparability of studies is limited due to diversity of study designs and outcome measurements. The presented study aims to develop a core outcome set consisting of a minimum of outcome measures deemed necessary for medical and therapeutic decision-making, which must be measured in all clinical trials and non-randomised intervention studies.

METHODS AND ANALYSIS: The study consists of several parts. First, the development and recommendation of preliminary core outcome domains will be based on results of a systematic review and structured online surveys. Participants of the expert panel are representatives of methodological, medical, physiotherapeutic, psychotherapeutic profession and patients suffering from chronic pain (n=25). Subsequently, candidate instruments to measure preliminary core outcome domains will be recommended by these experts. Therefore, systematic reviews on measurement properties of preliminary outcome measures will be conducted and finalised in a consensus meeting. Consented instruments and lacking psychometric properties of relevant instruments will be addressed and validated in the following part, a prospective multicentre study in multimodal pain centres on approximately 300 patients with chronic pain. Based on all previous results, a core outcome set for MPT measured in effectiveness studies and daily recordkeeping will be finalised by consensus. Statistical analyses will be performed according to methodological standards (COSMIN).

ETHICS AND DISSEMINATION: The methods and procedure of the study are developed in compliance with the ethical principles of the Helsinki Declaration and Good Epidemiologic Practice. Recruitment of study participants will require approval of the study by the responsible ethics committee and signed informed consent from each participant. Pseudonymised data will be used for statistical analysis.