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To further our understanding of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E17 guideline and promote effective implementation, a public workshop was held in Japan by regulatory agency and industry representatives. In this workshop, important concepts explained in the ICH E17 guideline, such as intrinsic/extrinsic ethnic factors that influence treatment effects ("effect modifiers") and the holistic evaluation of consistency of treatment effect were actively discussed through case studies. The importance of holistic evaluation of consistency was recognized, and it was concluded that the evaluation and relevant discussion should be shared with regulatory authorities, sponsors, and broader stakeholders. [ABSTRACT FROM AUTHOR]

Background: The evaluation of muscle pain and sensitivity by manual palpation is an important part of the clinical examination in patients with myalgia. However, the effects of clinical experience and visual feedback on palpation of the masticatory muscles with or without a palpometer are not known. Objective: To estimate the effects of clinical experience and visual feedback on the accuracy of palpation in standardized settings. Methods: Thirty‐two dentists (age 35 ± 11 years) classified as either specialists (n = 16) or generalists (n = 16) participated in this experiment. All dentists were instructed to target force levels of 500‐ or 1000‐gf, as determined on an electronic scale using either standardized palpometers or manual palpation (MP). All dentists participated in four different tests: MP, MP with visual feedback (MPVF), palpometer (PAL) and PAL with visual feedback (PALVF). Actual force values for each type of palpation from 0 to 2, 2 to 5 and 0 to 5 s were analysed by calculating target force level. Results: The relative differences during 2–5 and 0–5 s with 1000 gf were significantly lower for generalists than for specialists (p <.05). In generalists and specialists, the coefficients of variation and the relative differences during 2–5 s were significantly lower for PAL and PALVF than for MP (p <.05). Conclusions: These findings suggest that the use of a palpometer, but not clinical experience with palpation of masticatory muscles, increases the accuracy of palpation, and ≥2 s of palpation with a palpometer is optimal for masticatory muscles. [ABSTRACT FROM AUTHOR]

Background: The Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for use in adults is in use worldwide. Until now, no version of this instrument for use in adolescents has been proposed. Objective: To present comprehensive and short‐form adaptations of the adult version of DC/TMD that are appropriate for use with adolescents in clinical and research settings. Methods: International experts in TMDs and experts in pain psychology participated in a Delphi process to identify ways of adapting the DC/TMD protocol for physical and psychosocial assessment of adolescents. Results: The proposed adaptation defines adolescence as ages 10–19 years. Changes in the physical diagnosis (Axis I) include (i) adapting the language of the Demographics and the Symptom Questionnaires to be developmentally appropriate for adolescents, (ii) adding two general health questionnaires, one for the adolescent patient and one for their caregivers and (iii) replacing the TMD Pain Screener with the 3Q/TMD questionnaire. Changes in the psychosocial assessment (Axis II) include (i) adapting the language of the Graded Chronic Pain Scale to be developmentally appropriate for adolescents, (ii) adding anxiety and depression assessment that have been validated for adolescents and (iii) adding three constructs (stress, catastrophizing and sleep disorders) to assess psychosocial functioning in adolescents. Conclusion: The recommended DC/TMD, including Axis I and Axis II for adolescents, is appropriate to use in clinical and research settings. This adapted first version for adolescents includes changes in Axis I and Axis II requiring reliability and validity testing in international settings. Official translations of the comprehensive and short‐form to different languages according to INfORM requirements will enable a worldwide dissemination and implementation. [ABSTRACT FROM AUTHOR]

Background: The Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) are used worldwide in adults. Until now, no adaptation for use in children has been proposed. Objective: The aim of this study was to present comprehensive and short‐form adaptations of Axis I and Axis II of the DC/TMD for adults that are appropriate for use with children in clinical and research settings. Methods: Global Delphi studies with experts in TMDs and in pain psychology identified ways of adapting the DC/TMD for children. Results: The proposed adaptation is suitable for children aged 6–9 years. Proposed changes in Axis I include (i) adapting the language of the Demographics and the Symptom Questionnaires to be developmentally appropriate for children, (ii) adding a general health questionnaire for children and one for their parents, (iii) replacing the TMD Pain Screener with the 3Q/TMD questionnaire and (iv) modifying the clinical examination protocol. Proposed changes in Axis II include (i) for the Graded Chronic Pain Scale, to be developmentally appropriate for children, (ii) adding anxiety and depression assessments that have been validated in children and (iii) adding three constructs (stress, catastrophising and sleep disorders) to assess psychosocial functioning in children. Conclusion: The recommended DC/TMD, including Axis I and Axis II, for children aged 6–9 years, is appropriate for use in clinical and research settings. This adapted the first version for children includes changes in Axis I and Axis II changes requiring reliability and validity testing in international settings. Official translations to different languages according to INfORM requirements will enable a worldwide dissemination and implementation. [ABSTRACT FROM AUTHOR]