ABSTRACT
BACKGROUND: A core outcome set (COS) represents the agreed minimum set of domains and measurement instruments that should be measured and reported in any clinical trial for a given condition. In BMS randomized controlled trials (RCTs), the outcomes identified in the existing literature regarding the efficacy of therapeutic interventions are numerous and diverse. Although the standardized IMMPACT core outcome domains has been developed for measurement of outcomes in chronic pain RCTs, no BMS-specific COS have been adopted and validated. With the evolving landscape of BMS management end points and the development of new therapies, a consensus on a COS for use in future BMS trials is paramount to reduce heterogeneity in outcome reporting. The aim of this study was to reach a consensus for adopting the standardized Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) outcome domains, and their tools of assessment, for burning mouth syndrome (BMS) clinical trials and clinical practice. METHODS: A BMS-specific COS will be developed using the method recommended by the Core Outcome Measures in Effective Trials (COMET) initiative (Registration: http://www.comet-initiative.org/studies/details/1357 ). Selection of questionnaire outcome measures was informed by the IMMPACT consensus and previous systematic review of RCTs in BMS conducted by the consortium. An international group of clinicians and researchers will be invited to participate in several rounds of a Delphi survey. A consensus meeting will be held with the objective of ratifying the outcomes for inclusion in the COS. A finalized COS explanatory document will be drafted, including all outcomes and measurements as determined by the Delphi rounds and consensus meeting. DISCUSSION: A COS for the management of BMS will improve the quality of future RCTs, reduce outcome reporting heterogeneity, and facilitate more vigorous data synthesis of management interventions for systematic reviews and meta-analysis. This would ensure enhanced quality evidence for clinical management of the condition.
Subject(s)
Burning Mouth Syndrome , Research Design , Burning Mouth Syndrome/diagnosis , Burning Mouth Syndrome/therapy , Delphi Technique , Endpoint Determination , Humans , Meta-Analysis as Topic , Outcome Assessment, Health Care , Randomized Controlled Trials as Topic , Surveys and Questionnaires , Systematic Reviews as Topic , Treatment OutcomeABSTRACT
Numerous psychosocial factors have been shown to contribute to the development and perpetuation of orofacial pain. One well-recognized model for explaining the link between psychosocial factors and chronic pain is the fear avoidance model. To date, this proposed link has not been studied in subjects with orofacial pain. During the initial evaluation of subjects with orofacial pain, we collected data on fear avoidance beliefs using the Fear Avoidance Beliefs Questionnaire, and disability and pain. At between 6 and 8 weeks follow-up, we re-collected these data, as well as data addressing subjects' perceived change in their condition. Data were analyzed using correlation coefficients and linear regression. Fear avoidance beliefs at intake were inversely correlated with intake disability, There were no significant associations between fear avoidance beliefs at initial evaluation or in changes in fear avoidance beliefs during the 6-8 weeks follow-up period; and changes in disability, pain or perceived change in condition at 6-8 weeks follow-up. Of note, fear avoidance beliefs increased over the follow-up period, despite improvements in all outcome measures. There was insufficient evidence to suggest that high levels of fear avoidance beliefs at initial evaluation are associated with higher levels of disability or pain at intake, or with change in disability, pain or perceived change in condition at 6-8 weeks follow-up. Similarly, there was insufficient evidence to suggest that changes in fear avoidance beliefs during treatment are associated with any of these outcome measures.
Subject(s)
Activities of Daily Living/psychology , Avoidance Learning , Cognitive Behavioral Therapy , Facial Pain/psychology , Fear , Pain Measurement/instrumentation , Adult , Aged , Avoidance Learning/physiology , Disability Evaluation , Facial Pain/physiopathology , Facial Pain/therapy , Female , Follow-Up Studies , Humans , Linear Models , Male , Middle Aged , Outcome Assessment, Health Care , Predictive Value of Tests , Prospective Studies , Surveys and QuestionnairesABSTRACT
The purpose of this study was to review the current status of biomarkers used in oro-facial pain conditions. Specifically, we critically appraise their relative strengths and weaknesses for assessing mechanisms associated with the oro-facial pain conditions and interpret that information in the light of their current value for use in diagnosis. In the third section, we explore biomarkers through the perspective of ontological realism. We discuss ontological problems of biomarkers as currently widely conceptualised and implemented. This leads to recommendations for research practice aimed to a better understanding of the potential contribution that biomarkers might make to oro-facial pain diagnosis and thereby fulfil our goal for an expanded multidimensional framework for oro-facial pain conditions that would include a third axis.
