Objective
We used consensus-based, systematic protocols to evaluate the reliability and validity
of patient-reported outcome measures (PROMs) for use in documenting treatment outcomes
for temporomandibular disorders (TMDs).
Study Design
Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines,
we conducted a focused search of 5 literature databases resulting in a yield of 445
articles that qualified for full-text review. Our review identified 124 PROMs, from
which we selected 19 directly related to symptoms of TMD including temporomandibular
joint (TMJ) function.
Results
We abstracted data on 9 Consensus-based Standards of the selection of health Measurements
INstruments (COSMIN) measurement properties and analyzed these data according to COSMIN
criteria. Only 3 PROMs provided evidence for at least half of the COSMIN properties:
Eight-item Jaw Function Limitations Scale, Oral Health Impact Profile (OHIP)–TMD (OHIP-TMD),
and TMJ Ankylosis Specific Quality of Life Questionnaire. Only the OHIP-TMD provided
evidence for properties essential to evaluating change over time: reliability, measurement
error, and responsiveness.
Conclusion
We believe these results can alert clinical practitioners to gaps in our knowledge
about the most widely used PROMs in TMD practice, and identify topics requiring further
study for clinical researchers.
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References
- Temporomandibular joint disorders' impact on pain, function, and disability.J Dent Res. 2015; 94: 79s-86s
- Manual of Temporomandibular Disorders.Hooken (NJ). 3rd ed. John Wiley & Sons Inc, 2014
- Management of TMD: evidence from systematic reviews and meta-analyses.J Oral Rehabil. 2010; 37: 430-451
- Stabilisation splint therapy for temporomandibular pain dysfunction syndrome.Cochrane Database Syst Rev. 2004; Cd002778
- Occlusal adjustment for treating and preventing temporomandibular joint disorders.Cochrane Database Syst Rev. 2003; Cd003812
- Is nonsurgical management effective in temporomandibular joint disorders? - a systematic review and meta-analysis.Dent Res J (Isfahan). 2018; 15: 231-241
US Food and Drug Administration. Patient-Focused Drug Development: Methods to identify what is important to patients & select, develop or modify fit-for-purpose clinical outcomes assessments. https://www.fda.gov/drugs/news-events-human-drugs/patient-focused-drug-development-guidance-methods-identify-what-important-patients-and-select. Health and Human Services. 2018. Accessed August, 17, 2021
Food and Drug Administration-National Institutes of Health Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource. Silver Spring (MD), Bethesda (MD): Food and Drug Administration (US), National Institutes of Health (US); 2016.
US Food and Drug Administration. Patient-reported outcomes measures: use in medical product development to support labeling claims: guidance for industry and FDA staff. December 2009. FDA Website. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-developmentsupport-labeling-claims. Accessed August 17, 2021
US Food and Drug Administration. Qualification Process for Drug Development Tools: Guidance for Industry and FDA Staff. November 2020. FDA Website. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/qualification-process-drug-development-tools-guidance-industry-and-fda-staff. Accessed August 17, 2021
US Food and Drug Administration. Qualification of Medical Device Development Tools: Guidance for industry, tool developers, and FDA staff. August 2017. FDA website. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/qualification-medical-device-development-tools. Accessed August 17, 2021
- The PRISMA 2020 statement: an updated guideline for reporting systematic reviews.Int J Surg. 2021; 88105906
- Core outcome measures in effectiveness trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a 'core outcome set'.Trials. 2014; 15: 247
- How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline.Trials. 2016; 17: 449
- Formative versus reflective measurement models: two applications of formative measurement.J Bus Res. 2008; 61: 1250-1262
- Assessing the quality of available patient reported outcome measures for intermittent claudication: a systematic review using the COSMIN checklist.Eur J Vasc Endovasc Surg. 2015; 49: 316-334
- Effect of treatment of temporomandibular disorders (TMD) in patients with cervicogenic headache: a single-blind, randomized controlled study.Cranio. 2011; 29: 43-56
- Craniofacial pain and disability inventory (CF-PDI): development and psychometric validation of a new questionnaire.Pain Physician. 2014; 17: 95-108
- Validation of a web-based version of the craniofacial pain and disability inventory.J Oral Rehabil. 2020; 47: 802-808
- Cross-cultural adaptation, reliability and validity of the Italian version of the craniofacial pain and disability inventory in patients with chronic temporomandibular joint disorders.BMC Oral Health. 2019; 19: 244
- Brazilian Portuguese version of the craniofacial pain and disability inventory: cross-cultural reliability, internal consistency, and construct and structural validity.J Oral Facial Pain Headache. 2018; 32: 389-399
- Upper body motor function and swallowing impairments and its association in survivors of head and neck cancer: a cross-sectional study.PLoS One. 2020; 15e0234467
- Validity and reliability of the Eating Assessment Tool (EAT-10).Ann Otol Rhinol Laryngol. 2008; 117: 919-924
- Self-efficacy is associated with pain, functioning, and coping in patients with chronic temporomandibular disorder pain.J Orofac Pain. 2006; 20: 115-124
- Effectiveness of two different splints to treat temporomandibular disorders.J Orofac Orthop. 2015; 76: 318-327
- Factor and Rasch analysis of the Fonseca anamnestic index for the diagnosis of myogenous temporomandibular disorder.Braz J Phys Ther. 2017; 21: 120-126
- Transcultural adaptation and validation of the Fonseca Anamnestic Index in a Spanish population with temporomandibular disorders.J Clin Med. 2020; 9: 3230
- Severity oftemporomandibular disorders in women: validity and reliability of the Fonseca Anamnestic Index.Braz Oral Res. 2014; 28: 16-21
- Psychometric evaluation of the Chinese version of the Fonseca anamnestic index for temporomandibular disorders.J Oral Rehabil. 2020; 47: 313-318
- Accuracy of the Fonseca anamnestic index in the identification of myogenous temporomandibular disorder in female community cases.J Bodyw Mov Ther. 2015; 19: 404-409
- Development and validation of the Gothenburg Trismus Questionnaire (GTQ).Oral Oncol. 2012; 48: 730-736
- Further validation of the Gothenburg Trismus Questionnaire (GTQ).PLoS One. 2020; 15e0243805
- Comparative effectiveness of photobiomodulation and manual therapy alone or combined in TMD patients: a randomized clinical trial.Braz Oral Res. 2018; 32: e50
- A high prevalence of TMD is related to somatic awareness and pain intensity among healthy dentals.Acta Odontol Scand. 2018; 76: 387-393
- Kinesio taping for temporomandibular disorders: single-blind, randomized, controlled trial of effectiveness.J Back Musculoskelet Rehabil. 2016; 29: 373-380
- Influence of temple headache frequency on physical functioning and emotional functioning in subjects with temporomandibular disorder pain.J Orofac Pain. 2012; 26: 83-90
- Reliability, validity, and clinical utility of the research diagnostic criteria for Temporomandibular Disorders Axis II Scales: depression, non-specific physical symptoms, and graded chronic pain.J Orofac Pain. 2002; 16: 207-220
- Research diagnostic criteria for temporomandibular disorders: review, criteria, examinations and specifications, critique.J Craniomandib Disord. 1992; 6: 301-355
- The association between neck disability and jaw disability.J Oral Rehabil. 2010; 37: 670-679
- Quality of life, chronic pain, insomnia, and jaw malfunction in patients after alloplastic temporomandibular joint replacement: a questionnaire-based pilot study.Int J Oral Maxillofac Surg. 2021; 50: 948-955
- Relationship Between Cervical Musculoskeletal Impairments and Temporomandibular Disorders: Clinical and Electromyographic Variables.Ann Arbor (MI): ProQuest Information & Learning. 2010;
- Association of temporomandibular joint osseous changes with anxiety, depression, and limitation of mandibular function in elderly Vietnamese.East Asian Arch Psychiatry. 2019; 29: 20-25
- Validation of a Chinese version of the Jaw Functional Limitation Scale in relation to the diagnostic subgroup of temporomandibular disorders.J Oral Rehabil. 2020; 47: 1-8
- The jaw functional limitation scale: development, reliability, and validity of 8-item and 20-item versions.J Orofac Pain. 2008; 22: 219-230
- Translation and adaptation of the diagnostic criteria for temporomandibular disorders into the Malay language: psychometric evaluation of contents.J Oral Facial Pain Headache. 2020; 34: 323-330
- Evaluation of jaw functional limitation in TMD Patients using a Korean version of Jaw Functional Limitation Scale (JFLS).J Oral Med Pain. 2004; 29: 297-304
- Preliminary development and validation of the Jaw Functional Limitation Scale.Community Dent Oral Epidemiol. 2008; 36: 228-236
- Validity of a brief questionnaire in screening asymptomatic subjects from subjects with tension-type headaches or temporomandibular disorders.Community Dent Oral Epidemiol. 1994; 22: 235-242
- Cross-cultural adaptation of the JPF-Questionnaire for German-speaking patients with functional temporomandibular joint disorders.J Craniomaxillofac Surg. 2006; 34: 226-233
- Comparison of instruments used to select and classify patients with temporomandibular disorder.Acta Odontol Latinoam. 2018; 31: 16-22
- Development of a new questionnaire to assess pain-related limitations of daily functions in Japanese patients with temporomandibular disorders.Community Dent Oral Epidemiol. 2005; 33: 384-395
- Jaw dysfunction is associated with neck disability and muscle tenderness in subjects with and without chronic temporomandibular disorders.Biomed Res Int. 2015; 2015512792
- Development and validation of the Manchester orofacial pain disability scale.Commun Dent Oral Epidemiol. 2005; 33: 141-149
- Translation and cross-cultural adaptation of the manchester orofacial pain disability scale.J Oral Maxillofac Res. 2013; 3: e3
- Assessment of mandibular function impairment associated with temporomandibular joint osteoarthrosis and internal derangement.J Orofac Pain. 1993; 7: 183-195
- Translation and validation of a Chinese version of the Mandibular Function Impairment Questionnaire.J Oral Rehabil. 2016; 43: 608-614
- The smallest detectable difference of mandibular function impairment in patients with a painfully restricted temporomandibular joint.J Dent Res. 1999; 78: 1445-1449
- Validity of the Oral Behaviours Checklist: correlations between OBC scores and intensity of facial pain.J Oral Rehabil. 2014; 41: 115-121
- Cultural equivalence, reliability and utility of the Portuguese version of the Oral Behaviours Checklist.J Oral Rehabil. 2018; 45: 924-931
- Validity and reliability of the Portuguese version of Mandibular Function Impairment Questionnaire.J Oral Rehabil. 2012; 39: 377-383
- Oral behaviors checklist: reliability of performance in targeted waking-state behaviors.J Orofac Pain. 2006; 20: 306-316
- OHIP-TMDs: a patient-reported outcome measure for temporomandibular disorders.Commun Dent Oral Epidemiol. 2015; 43: 461-470
- Functional, physical and psychosocial impact of temporomandibular disorders in adolescents and young adults.Med Oral Patol Oral Cir Bucal. 2020; 25: e188-e194
- Clinical efficacy of a simplified approach to managing chronic temporomandibular disorders: evidence from a 1-year case series.Oral Surg Oral Med Oral Pathol Oral Radiol. 2019; 128: 227-234
- Association between temporomandibular symptoms, anxiety and quality of life among nursing students.Collegian. 2019; 26: 373-377
- Temporomandibular disorder symptoms and their association with quality of life, emotional states and sleep quality in South-East Asian youths.J Oral Rehabil. 2018; 45: 756-763
- Creating a patient-based condition-specific outcome measure for temporomandibular disorders (TMDs): Oral Health Impact Profile for TMDs (OHIP-TMDs).J Oral Rehabil. 2011; 38: 871-883
- Validation of the Chinese version of the oral health impact profile for TMDs (OHIP-TMDs-C).Med Oral Patol Oral Cir Bucal. 2015; 20: e161-e166
- Development and Validation of Malay Version of Fonseca Anamnestic Index (FAI) & Oral Health Impact Profile for Temporomandibular Disorder (OHIP-TMD)/Muzaffar Apipi.University of Malaya, Kuala Lampur (Malaysia)2018
- The effect of temporomandibular disorders on condition-specific quality of life in patients with dentofacial deformities.Oral Surg Oral Med Oral Pathol Oral Radiol. 2014; 117: 293-301
- Temporomandibular joint effusion and its relationship with perceived disability assessed using musculoskeletal ultrasound and a patient-reported disability index.Ultrasound. 2015; 23: 90-96
- The Steigerwald/Maher TMD disability questionnaire. Today's Chiropractic. 1997; : 86-91
- Efficacy of Maitland joint mobilization technique on pain intensity, mouth opening, functional limitation, kinesiophobia, sleep quality and quality of life in temporomandibular joint dysfunction following bilateral cervicofacial burns.Burns. 2020; 46: 1880-1888
- Development and validation of temporomandibular joint ankylosis quality of life questionnaire.J Craniomaxillofac Surg. 2020; 48: 779-785
Article info
Publication history
Published online: August 11, 2022
Accepted:
August 3,
2022
Received in revised form:
July 7,
2022
Received:
October 1,
2021
Identification
Copyright
Published by Elsevier Inc.
