An international Delphi survey and consensus meeting to define the core outcome set for trigeminal neuralgia clinical trials.

BACKGROUND: Trigeminal neuralgia (TN) is an excruciating unilateral facial pain, which negatively affects patient's quality of life. Historically, it has been difficult to compare treatment efficacy due to the lack of standardized outcomes. In addition, patients' perspective has seldomly been acknowledged. The aim of this study was to reach consensus on what outcomes of treatment are important to different TN stakeholders (patients, clinicians and researchers), to identify the TN Core Outcome Set (TRINCOS). METHODS: A list of outcomes identified through a systematic review and focus group work was used to develop the survey questionnaire. A three-round Delphi was conducted. Participants were asked to score the outcomes on scale from 1 to 9 (1-3 not important;4-6 important but not critical;7-9 critical). Outcomes scored as critical by ≥70% and not important by <15% were retained, and those for which no consensus was reached were discussed at a consensus meeting. RESULTS: Of the 70 participants who completed the Delphi, 26 were patients, 38 were clinicians and six were researchers. Of the 40 outcomes presented, 17 were scored as critical and no consensus was met for 23 outcomes. Agreement was reached during a consensus meeting on 10 outcomes across six domains (pain, side effects, social impact, quality of life, global improvement, and satisfaction with treatment). CONCLUSION: Implementation of TRINCOS in future clinical trials will improve homogeneity of studies' results, reduce the redundancy in the outcome assessment and effectively allow comparison of different treatments to better inform researchers, clinicians and most importantly patients, about the efficacy of the different treatments. SIGNIFICANCE: Implementation of a 10-item core outcome set in trigeminal neuralgia will improve comparability between studies allowing patients to have faster access to better treatments.

Patient reported outcome measures in trigeminal neuralgia - A systematic review of psychometric performance.

BACKGROUND: Trigeminal neuralgia (TN) is a rare condition for which there are multiple treatment options available. To date, there has been difficulty in comparing the outcomes of treatment due to the variety of patient-reported outcome measures (PROMs) and their inadequate psychometric testing. The aim of this review was to assess the psychometric properties of PROMs used to date in TN and make recommendations for their use in future studies. METHODS: Five electronic databases (MEDLINE, EMBASE, CINAHL Plus, PsycINFO, Health and Psychosocial Instruments) were searched for studies assessing the development of PROMs or their psychometric properties in TN studies. The records obtained were assessed independently by two reviewers for their methodological quality, following guidance from the Consensus-based Standards for the selection of Health Measurement Instruments (COSMIN). RESULTS: Six studies were identified and information on five PROMs (Brief Pain Inventory Facial (BPI-F), Visual Analogue Scale (VAS), Barrow Neurology Institute Pain Scale (BNI-PS), Penn Facial Pain Scale-Revised (Penn-FPS-R) and Trigeminal Neuralgia Quality of Life Score) were retrieved. The Penn-FPS-R demonstrated moderate quality evidence for sufficient content validity. The BPI-F showed moderate evidence for sufficient internal consistency and structural validity but low evidence for inconsistent content validity. The Trigeminal Neuralgia Quality of Life score showed very low-quality evidence for insufficient content validity, structure validity and responsiveness. No evidence was found on the assessment of any psychometric properties of the VAS and BNI-PS in TN. CONCLUSION: There is limited evidence of the psychometric performance of patient-reported outcomes for TN and recommendations for their inclusion in future studies cannot be made. The validation of PROMs in TN studies should be a priority in this field of research. SIGNIFICANCE: This review highlights the knowledge gap in the field of psychometrics of patient reported outcomes measures in the field of TN. Given the unavailability of an objective outcome measure for pain or health related quality of life, psychometrically sound PROMs are essential for assessing medical and surgical treatment outcomes in TN.

Accuracy of the painDETECT screening questionnaire for detection of neuropathic components in hospital-based patients with orofacial pain: a prospective cohort study.

BACKGROUND: Better tools are required for the earlier identification and management of orofacial pain with different aetiologies. The painDETECT questionnaire is a patient-completed screening tool with utility for identification of neuropathic pain in a range of contexts. 254 patients, referred from primary care for management of orofacial pain and attending a secondary care centre, were prospectively recruited, and completed the painDETECT prior to consultation. The aim of this study was to determine the accuracy of the painDETECT to detect neuropathic components of orofacial pain, when compared to a reference standard of clinical diagnosis by experienced physicians, in a cohort of hospital-based patients. RESULTS: For the 251 patients included in the analysis, the painDETECT had a modest ability to detect neuropathic components of orofacial pain (AUROC, 0.63; 95% CI, 0.58-0.70; p = 0.001). Patients with orofacial pain diagnoses associated with neuropathic components had higher painDETECT scores than those with non-neuropathic components. However, the painDETECT was weaker at distinguishing patients with mixed pain types, and multiple diagnoses were associated with poor accuracy of the painDETECT. CONCLUSION: In secondary care settings, the painDETECT performed modestly at identifying neuropathic components, and underestimates the complexity of orofacial pain in its mixed presentations and with multiple diagnoses. Prior to clinical applications or research use, the painDETECT and other generic screening tools must be adapted and revalidated for orofacial pain patients, and separately in primary care, where orofacial pain is considerably less common.