World Workshop in Oral Medicine VII: Reporting of IMMPACT‐recommended outcome domains in randomized controlled trials of burning mouth syndrome: A systematic review

Farag, Arwa M.; Albuquerque, Rui; Ariyawardana, Anura; Chmieliauskaite, Milda; Forssell, Heli; Nasri-Heir, Cibele; Klasser, Gary D.; Sardella, Andrea; Mignogna, Michele Davide; Ingram, Mark; Carlson, Charles R.; Miller, Craig S.

doi:10.1111/odi.13053

Cited by 24 publications

(21 citation statements)

References 59 publications

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“…We also found significant improvement in the study group functioning, emotional functioning, patient's satisfaction and adverse events must be measured in order to get high-quality studies (Farag et al, 2019). For this reason, we have followed the IMMPACT recommendations for chronic pain clinical trials exposed at the World Workshop on Oral Medicine VII (Farag et al, 2019 (Alonso, Prieto, & Antó, 1995), OHIP-14 for the patient's oral quality of life (Montero-Martin et al, 2009), Epworth sleepiness scale (Chiner, Arriero, Signes-Costa, Marco, & Fuentes, 1999), psychometric SCL-90-R (Derogatis 2001) and the McGill Pain Questionnaire (Lahuerta et al, 1982). A previous systematic review recommended parameters of wavelength (more than 815 nm), power (between 300 mW and 1 W), beam area (0.28 cm 2 ), frequency (continuous), time per point (10 s) and number of sessions (10) to achieve better results (de Pedro et al, 2020).…”

Section: Discussionmentioning

confidence: 84%

“…The World Workshop on Oral Medicine VII the IMMPACT recommendations for chronic pain clinical trials were advocated for future studies about BMS treatment in order to measure pain, physical functioning, emotional functioning, participation of global improvement and satisfaction with treatment, symptoms and adverse events and participant disposition (Farag et al., 2019). Therefore, the main objective of this study is to assess the effects of PBM with LLLT on the pain management in BMS patients, besides assessing its quality of life impact through the questionnaires McGill, the Short Form 36 Health Survey (SF‐36), the Oral Health Impact Profile (OHIP‐14), the Epworth sleepiness scale and the psychometric test Symptom Check List 90 (SCL 90‐R).…”

Section: Introductionmentioning

confidence: 99%

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Effects of photobiomodulation with low‐level laser therapy in burning mouth syndrome: A randomized clinical trial

et al. 2020

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Background: Photobiomodulation (PBM) has proven to be effective in different painful conditions. Objectives: To assess the effect of photobiomodulation for pain management in burning mouth syndrome (BMS) patients, besides analysing the impact on different aspects of quality of life. Methods: A randomized, single-blind, clinical trial was performed among 20 patients with BMS. Photobiomodulation was applied in the study group (n = 10) with a dose of 12 J/cm 2 during 10 sessions, comparing with a placebo group (n = 10) with the laser turned off. Pain was assessed using the visual analogue scale (VAS) before starting each treatment session, and at the 1-month and 4-month follow-up appointments. Some validated questionnaires for general health were also complete: SF-36, OHIP-14, Epworth, SCL 90-R and McGill. Results: All patients (n = 10) in the study group improved their pain ending treatment and remaining among 90% (n = 9) in the 4-month follow-up. Significant improvement was found in the study group in some sections of McGill questionnaire, Epworth scale, and SCL 90-R at the end of the treatment and in the 1-month and 4-month follow-ups. Conclusions: Photobiomodulation seems to be effective in reducing pain in patients with BMS, as well as, having a positive impact on the psychological state of these patients.

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Section: Discussionmentioning

confidence: 84%

Section: Introductionmentioning

confidence: 99%

Effects of photobiomodulation with low‐level laser therapy in burning mouth syndrome: A randomized clinical trial

et al. 2020

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“…A further 15 studies suggested potential barriers that may have resulted in low uptake of the COS (Table 3). The absence of validated measures, or no consensus on which instruments should be used to assess the domains, was noted in four studies [11,25,26,29]. Six studies referred to a limited patient or other key stakeholder involvement in the development of the COS as a potential barrier to uptake.…”

Section: Suggested Barriers To Uptake Of Cosmentioning

confidence: 99%

A systematic review finds Core Outcome Set uptake varies widely across different areas of health

Hughes

Clarke

Williamson

2021

Journal of Clinical Epidemiology

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The aim of our review was to bring together studies that had assessed the uptake of core outcome sets (COS) to explore the level of uptake across different COS and areas of health. Study Design and Setting: We examined the citations of 337 COS reports to identify studies that had assessed the uptake of a particular COS in randomized controlled trials (RCTs) or systematic reviews (SRs). Results: We identified 24 studies that had assessed uptake in RCTs and two studies that had assessed uptake in SRs. The studies covered a total of 17/337 (5%) COS. Uptake rates reported for RCTs varied from 0% of RCTs (gout) to 82% RCTs (rheumatoid arthritis) measuring the full COS. Studies that assessed uptake of individual core outcomes showed a wide variation in uptake between the outcomes. Suggested barriers to uptake included lack of validated measures, lack of patient and other key stakeholder involvement in COS development, and lack of awareness of the COS. Conclusions: Few studies have been undertaken to assess the uptake of COS in RCTs and SRs. Further studies are needed to assess whether COS have been implemented across a wider range of disease categories and to explore the barriers and facilitators to COS uptake.

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“…A systematic literature review has previously been conducted to identify potential efficacy and safety outcomes currently reported in BMS RCTs (i.e., IMMPACT outcome domains) [1]. A search of the COMET initiative database (http://www.comet-initiative.org/) was completed prior to commencing this project.…”

Section: Methodsmentioning

confidence: 99%

“…Randomized controlled trials (RCTs) represent the gold standard for generating evidence on the efficacy of clinical interventions and should incorporate clearly defined outcome measures. The outcome measures identified in published RCTs concerning the efficacy of therapeutic interventions in burning mouth syndrome (BMS) are numerous and inconsistent [ 1 ]. To date, no BMS-specific outcome measures exist.…”

Section: Introductionmentioning

confidence: 99%

IMMPACT-recommended outcome measures and tools of assessment in burning mouth syndrome RCTs: an international Delphi survey protocol

Carey

Farag

Nasri-Heir

et al. 2020

Trials

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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.

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World Workshop in Oral Medicine VII: Reporting of IMMPACT‐recommended outcome domains in randomized controlled trials of burning mouth syndrome: A systematic review

Cited by 24 publications

References 59 publications

Effects of photobiomodulation with low‐level laser therapy in burning mouth syndrome: A randomized clinical trial

Effects of photobiomodulation with low‐level laser therapy in burning mouth syndrome: A randomized clinical trial

A systematic review finds Core Outcome Set uptake varies widely across different areas of health

IMMPACT-recommended outcome measures and tools of assessment in burning mouth syndrome RCTs: an international Delphi survey protocol

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