The JFLS-20 is a 20-item measure derived through expert consensus and subsequently validated using Rasch methodologies in a sample of patients with TMD, primary Sjogren syndrome, burning mouth syndrome, skeletal malocclusion, and healthy controls.19 It includes 3 subscales (mastication, vertical jaw mobility, and verbal and emotional expression) and a global scale of functional limitation of the jaw. The 8-item global scale of functional limitation of the jaw is known as the JFLS-8. The JFLS-8 and the JFLS-20 can both be appropriately utilized to measure TMD dysfunction in clinical and research settings.19,20 Both scales require the patient to rank their level of difficulty on an 11-point Likert scale, where zero suggests “no limitation” and a response of 10 suggests “severe limitation.” The recall period is one month. The total score is calculated by summing the individual item scores, with a higher score indicating greater limitation.19 The JFLS-20 score can range from 0-200 and the JFLS-8 score can range from 0-80.
Internal consistency (Cronbach's alpha) for the JLFS-8 is 0.87 and for the JFLS is 0.95.19 Test-retest reliability, assessed through temporal stability and the concordance correlation coefficient, (CCC rho), is 0.81 for the JFLS-8 and 0.87 for the JFLS-20.19 An effect size for the JFLS-8 of 0.41 has been reported.20 When analyzed separately, the 3 subscales of the JFLS-20 each exhibited excellent psychometric properties with respect to modeled variance, item fit, reliability, and internal consistency among the 5 diagnostic groups.19 Construct and discriminant validity have been established through correlations with other measures, established between-group differences in the subscale and global functional limitation scores,19 and test score independence from constructs such as depression, somatization, anxiety, and other clinical findings.20 The JFLS-8 and the JFLS-20 are also highly correlated (0.9675).19 Neither the JFLS-8 nor JFLS-20 has been used in published HNC research.
The TMD pain screener is a 3-item PRO with a recall period of the last 30 days. The first item addresses the frequency of pain (“no pain,” “pain comes and goes,” “pain is always present”). A response of “no pain” yields a score of zero, “pain comes and goes” yields one point, and “pain is always presents” yields two points. The second item addresses pain or stiffness upon awakening, and the third item is a 4-part question assessing a change in pain level for certain functional activities including chewing, opening/moving the jaw, grinding/clenching, and kissing/talking/yawning. Item two and the 4 components of item three have dichotomous response options of “no” and “yes.” A “no” is awarded zero points and a “yes” is awarded one point. Item scores are then summed, with a test score of zero to 7 points possible. A higher score indicates greater limitation. In a population of subjects with pain-related TMD, internal consistency was deemed excellent (Cronbach's α = 0.87), and temporal stability of individual items (κ) ranged from 0.52 to 0.78, indicating fair to excellent agreement. The summary test score exhibited an intraclass correlation coefficient of 0.83. The tool was found to exhibit sensitivity of 99% and a specificity of 97%. The positive likelihood ratio ranged from 19.2 to 44.6, varying according to the comparison control group, whereas the negative likelihood ratio was 0.01 throughout. Both positive and negative likelihood ratio findings exceeded the accepted benchmarks of 10 or more and 0.1 or less for the positive and negative likelihood ratios, respectively. The TMD Pain Screener has not been used in HNC research.21
The GCPS (version 2.0) is an 8-item PRO. In general, symptom recall is for the last 30 days; however, one item has a 24-hour recall and another item has a 6-month recall period. Six of the items are scored on an 11-point Likert scale, with a response of zero indicating no interference or pain and a response of 10 indicating “pain as bad as could be” or “unable to carry on any activities.” Item one requires the patient to report the number of days the patient experienced facial pain in the past 6 months, and item 5 requires the patient to report the number of days facial pain limited performance of usual activities in the past 30 days. Scores are calculated for 3 subscales: the characteristic pain intensity score, which ranges from 0-100, is calculated as the mean intensity ratings for reported current, worst, and average pain; the disability score, which ranges from 0-100, is calculated as the mean rating for difficulty performing daily, social, and work activities; and the disability points score, which ranges from 0-3, is derived from a combination of ranked categories of number of disability days and disability score. Subscale scores for pain intensity and disability are combined to calculate a chronic pain grade that enables classification of chronic pain patients into 5 hierarchical categories: grades 0 (no pain) to IV (high disabilityseverely limiting).22
The GCPS is a reliable and valid instrument that assesses the constructs of pain intensity and pain-related disability. The measure's psychometric properties were studied in a population of patients with back pain, headache, and TMJ disorders. The internal consistency was measured with Cronbach's α = 0.84 for the pain intensity subscale and Cronbach's α = 0.95 for the pain-related disability subscale. The temporal stability (2-7 days) was high for pain intensity (CCC = 0.91), pain-related disability (CCC = 0.89), and chronic pain grade (weighted kappa = 0.87).22 Among patients with moderate to severe chronic musculoskeletal pain, the GCPS has been shown to be modestly responsive to changes after 12 months of treatment with an efficacious pain intervention, with standardized moderate effect sizes for the intensity and disability sub-scales of 0.41 and 0.43, respectively. Among participants with chronic knee or hip pain, the standardized effect size for the GCPS intensity was 0.32.23 The GCPS has not been used in HNC research.
“Unable to Recommend at This Time” TMD Outcomes Measures
Sixteen outcome measures received a score of 2 and are not recommended at this time for use by physical therapists treating individuals with TMD in the setting of HNC. A score of 2 is further categorized as 2A if the measure has been used in the HNC literature or 2B if there is no published evidence that the tool has been used in HNC-related research. Six PROs were designated a rating of 2A, including the EORTC QLQ H&N43,24 University of Washington Quality of Life (UW-QOL),25,26 Liverpool Oral Rehabilitation Questionnaire version 3 (LORQ),27 University of California San Francisco (UCSF) Oral Cancer Pain Questionnaire,28 the Gothenburg Trismus Questionnaire (GTQ),29 and the Late Effects in Normal Tissues Subjective, Objective, Management and Analytic Scales (LENT/SOMA).30
Two HNC-specific QOL measures were included in the review, the EORTC QLQ H&N 43 and the UW-QOL. The EORTC QLQ H&N43 is the most recent revision of the EORTC QLQ-H&N 35. It currently lacks psychometric studies to support its use. More importantly, similar to the UW-QOL, the EORTC QLQ-H&N43 is a measure designed to quantify health-related QOL and therefore provides a test score interpreted as an overall QOL score for many constructs, not a score specific to TMD. As a result, these two HNC-specific QOL measures cannot be recommended solely for quantification of TMD dysfunction.
The LORQ is a 40-item measure developed through expert opinion. It addresses issues related to oral function, oro-facial appearance, social interaction, and dentures/dental prostheses. While the tool is relevant to the HNC population, it lacks strong psychometric properties and easy accessibility to scoring and interpretation. In addition, over half of the questions pertain to oral prosthetics, therefore decreasing its utility for a large portion of the HNC population.27 The UCSF Oral Cancer Pain Questionnaire is an 8-item PRO used to quantify patients' pain levels before and after surgical resection for oral cancer. Items one, 3, and 5 evaluate the intensity, sharpness and throbbing nature of pain when the patient is not engaged in oral function. Items 2, 4, and 6 measure the intensity, sharpness, and throbbing nature of pain during oral function (talking, eating, and drinking).28 Although some of these items are related to TMJ function, this tool is not specific to TMD and has not been validated for patients with TMD. In addition, the measure is not easily accessible to clinicians. The GTQ is the only measure reviewed specifically designed to measure trismus.29 Unfortunately, the tool is not easily accessible and lacks supporting research. The LENT/SOMA scale addresses radiotherapy toxicities in patients with HNC and is therefore not relevant for use by physical therapists.30
Ten PROs reviewed received a 2B rating, including: Subjective Oral Health Status Indicators (SOHSI),31,32 10-item TMJ Pain Questionnaire,33 Mandibular Function Impairment Questionnaire (MFIQ),34 Modified Symptom Severity Index (SSI),35 TMD Checklist,36 TMJ Scale,19 TMD Questionnaire (LDF-TMDQ), which is also known as the Jaw Function Scale,37 the Manchester Orofacial Pain Disability Scale (MOPDS),38 Tampa Scale for Kinesiophobia,39 and the TMD Self-efficacy Scale.40
Although the SOHSI, 10-item TMJ Pain Questionnaire, MFIQ, Modified SSI, and TMD Checklist may appropriately measure the construct of TMD dysfunction, the questionnaires and information on scoring and interpretation are not easily accessible by clinicians and therefore cannot be recommended. The TMJ Scale is, however, accessible to clinicians, but at a financial cost. It is also 97-items in length and therefore not feasible for use in a busy clinical setting.19 Our review also found that the LDF-TMDQ and the MOPDS have been developed in other countries and may lack validity in the United States. Two PROs, Tampa Scale for Kinesiophobia, and TMD Self-Efficacy Scale, may be of benefit for use in a holistic assessment of TMD, however, do not specifically address the construct of TMD and therefore cannot be recommended at this time.
“Not Recommended” TMD Outcome Measures
Four outcome measures were given the lowest score of 1 and are not recommended secondary to limited to no available research supporting the psychometric properties of the tools across all patient populations. These outcome measures include the Conti Anamnestic Questionnaire,41 the Oral Impacts on Daily Performance,42,43 TMD Disability Index,44 and the TMJ Score Questionnaire.45
The APTA's Oncology Section Head and Neck EDGE Task Force recommends that physical therapists use the GCPS, JFLS-8 or JFLS-20, and/or the TMD Pain Screener to quantify TMD in patients with HNC. These measures merited a score of 3, “recommended,” because they demonstrate good psychometric properties, but have not been tested or utilized in HNC literature. Each of the recommended measures can be found in the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), which is a compilation of clinical and patient-reported measures designed to assess TMD in clinical and research settings.46 The DC/TMD has two components, Axis I and Axis II. Axis I of the DC/TMD includes the TMD Pain Screener, a symptom questionnaire, demographics, and a clinical examination. Axis II includes various PROs addressing constructs related to QOL, anxiety, depression, and TMD, including the JLFS-8, JLFS-20, and GCPS.47
Only 6 of the 22 measures reviewed in this study have been used in the HNC literature, all of which were not recommended at this time due to concerns regarding tool accessibility, clinical utility, test score interpretation specifically for TMD dysfunction, and availability of psychometric data to merit their use. Given the lack of PROs related to TMJ dysfunction designed for the HNC population, physical therapists are left to use TMJ-related outcome measures that have been designed for other patient populations whose needs may be quite different than the particular concerns of a patient with HNC. Additional research is therefore required to determine the psychometric properties of the measures recommended by the HNC EDGE Task Force in the HNC population, and to further study relevant PROs that could not be recommended by the Task Force at this time. For example, the TMD Disability Index is similar in format to the Oswestry Disability Index and Neck Disability Index, both frequently used PROs in the physical therapy profession for back and neck pain, and has been used in physical therapy research.48-51 Despite its use, the TMD Disability Index received a rating of “not recommended” because psychometric properties for the measure have not been reported.
A systematic review of the literature to identify publications utilizing PROs suitable for oral and maxillofacial surgery found there are numerous questionnaires available, however selecting the most appropriate one can be difficult.52 Ojo and colleagues53 explored HNC QOL instruments and determined that crossstudy comparisons have been hampered by the heterogeneity of measures used in research and the fact that reviews of HNC instruments have not been comprehensively studied. Given the volume and heterogeneity of PROs there is no gold standard HNC-specific TMD questionnaire.53
Similar to the Oncology Section's HNC EDGE Task Force's reviews on neck and shoulder PROs and measurement of external lymphedema for HNC survivors, 54,55,58 the obvious limitation in this review, was that very few of the measures reviewed have actually been utilized to evaluate TMJ-related impairment and disability in the HNC patient population. Referral to physical therapy for HNC related-TMD is underutilized.56 In addition, there are a limited number of investigators with expertise in TMJ-related impairments and function conducting research in the HNC population. Prolonged survivorship due to improved medical management of HNC increases the importance of restoring optimal function in order to improve QOL and function.56 Given the rise in HPV-associated HNCs, improvements in early detection, prevention, and medical management strategies, patients with HNC may have unmet physical therapy needs to reduce or prevent TMJ disability.
To our knowledge, this is the first attempt at providing recommendations for TMD-specific PRO utilization by physical therapists treating patients with HNC. Future research should consider the psychometric properties of PROs, including establishment of normative values and responsiveness to change, addressing TMD in the HNC population. Although great strides have been made in the assessment of PROs and QOL in HNC, more work is needed to improve the clinical utility of these measures in order to link research to clinical practice.9,53,57
The HNC EDGE Task Force recommendations provide physical therapists with evidence-based outcomes measure recommendations for use with patients with HNC presenting with TMD. The HNC EDGE Task Force recommends 4 measures that are easy to use in the clinic with good psychometric properties. These measures fulfill Medicare functional outcome reporting requirements and can provide reliable and valid data from which to quantify patient response to physical therapy interventions.
Our review reveals a gap in psychometric research evaluating properties of available TMJ-related PROs applied in the HNC population. The HNC EDGE Task Force reviews include recommendations for other areas that affect HNC patients that fall under the scope of practice for physical therapy such as neck,54 shoulder,55 and lymphedema.58 Further research is needed to evaluate psychometric properties of PROs for use in the HNC patient population. Studies evaluating HNC-specific PROs' responsiveness to change, generation of normative values, and reliability and construct validity in the HNC patient population are needed. The HNC EDGE Task Force recommendations are a first-step to fill the gap in knowledge of useful, relevant, and patient friendly TMJ-related outcome measures for the HNC patient population.
No funding was available for this project. All Task Force member efforts were on a volunteer basis. We would like to thank Kelsey Watkins, Student Physical Therapist (Class of 2015) from Stockton University, for her research assistance in this manuscript, and Eliane Purchase, Medical Librarian at the Mayo Clinic in Arizona, for her assistance in developing the research search strategy.
Please note: The appendices for this article can be viewed online at: http://www.ocnologypt.org/publications/rehabilitation-oncology-journal
1. National Cancer Institute. SEER Cancer Statistics Review, 1975-2010. http://seer.cancer.gov/csr/1975_2010/
. Accessed based on November 2012 SEER data submission, posted to the SEER web site, April 2013.
2. Shone GR, Yardley MP. An audit into the incidence of handicap after unilateral radical neck dissection. J Laryngol Otol.
3. Oz B, Memis A. Development of musculoskeletal complaints and functional disabilities in patients with laryngeal carcinoma after neck dissection sparing spinal accessory nerve. Eur J Cancer Care (Engl).
4. Bensadoun RJ, Riesenbeck D, Lockhart PB, Elting LS, Spijkervet FK, Brennan MT. A systematic review of trismus induced by cancer therapies in head and neck cancer
patients. Support Care Cancer.
5. Okeson J. Etiology of functional disturbances in the masticatory system. Management of Temporomandibular Disorders and Occlusion.
6th ed. St Louis, MO: Mosby Year Book Publication, Inc; 2008:130-163.
6. Weber C, Dommerich S, Pau HW, Kramp B. Limited mouth opening after primary therapy of head and neck cancer
. J Oral Maxillofac Surg.
7. Louise Kent M, Brennan MT, Noll JL, et al. Radiationinduced trismus in head and neck cancer
patients. Support Care Cancer.
9. Cousins N, MacAulay F, Lang H, MacGillivray S, Wells M. A systematic review of interventions for eating and drinking problems following treatment for head and neck cancer
suggests a need to look beyond swallowing and trismus. Oral Oncol.
10. Pauli N, Johnson J, Finizia C, Andrell P. The incidence of trismus and long-term impact on health-related quality of life in patients with head and neck cancer
. Acta Oncol.
11. Chera BS, Eisbruch A, Murphy BA, et al. Recommended patient-reported core set of symptoms to measure in head and neck cancer
treatment trials. J Natl Cancer Inst.
12. Tschiesner U, Rogers S, Dietz A, Yueh B, Cieza A. Development of ICF core sets for head and neck cancer
. Head Neck.
13. van Wilgen CP, Dijkstra PU, van der Laan BF, Plukker JT, Roodenburg JL. Morbidity of the neck after head and neck cancer
therapy. Head Neck.
14. Speksnijder CM, van der Bilt A, Slappendel M, de Wijer A, Merkx MA, Koole R. Neck and shoulder function in patients treated for oral malignancies: a 1-year prospective cohort study. Head Neck.
15. Ahlberg A, Nikolaidis P, Engstrom T, et al. Morbidity of supraomohyoidal and modified radical neck dissection combined with radiotherapy for head and neck cancer
: a prospective longitudinal study. Head Neck.
16. Ringash J, Bernstein L, Cella D, et al. Outcomes toolbox for head and neck cancer
research. Head Neck.
18. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med.
19. Ohrbach R, Larsson P, List T. The jaw functional limitation scale: development, reliability, and validity of 8-item and 20-item versions. J Orofacial Pain.
20. Ohrbach R, Granger C, List T, Dworkin S. Preliminary development and validation of the Jaw Functional Limitation Scale. Community Dent Oral Epidemiol.
21. Gonzalez YM, Schiffman E, Gordon SM, et al. Development of a brief and effective temporomandibular
disorder pain screening questionnaire: reliability and validity. J Am Dent Assoc.
22. Ohrbach R, Turner JA, Sherman JJ, et al. The Research Diagnostic Criteria for Temporomandibular
Disorders. IV: evaluation of psychometric properties of the Axis II measures. J Orofacial Pain.
23. Elliott AM, Smith BH, Hannaford PC, Smith WC, Chambers WA. Assessing change in chronic pain severity: the chronic pain grade compared with retrospective perceptions Br J Gen Pract.
27. Pace-Balzan A, Cawood JI, Howell R, Butterworth CJ, Lowe D, Rogers SN. The further development and validation of the Liverpool Oral Rehabilitation Questionnaire: a crosssectional survey of patients attending for oral rehabilitation and general dental practice. Int J Oral Maxillofac Surg.
28. Kolokythas A, Connelly ST, Schmidt BL. Validation of the University of California San Francisco Oral Cancer Pain Questionnaire. J Pain.
29. Johnson J, Carlsson S, Johansson M, et al. Development and validation of the Gothenburg Trismus Questionnaire (GTQ). Oral Oncol.
31. Locker D. Subjective Oral Health Status Indicators. In: Slade G, ed. Measuring Oral Health and Quality of Life.
Chapel Hill: University of North Carolina, Dental Ecology; 1997:105-112.
32. Locker D, Miller Y. Evaluation of Subjective Oral Health Status Indicators. J Public Health Dent.
33. Braun B, Schiffman EL. The validity and predictive value of four assessment instruments for evaluation of the cervical and stomatognathic systems. J Craniomandib Disord.
34. Stegenga B, de Bont LG, de Leeuw R, Boering G. Assessment of mandibular function impairment
associated with temporomandibular
joint osteoarthrosis and internal derangement. J Orofac Pain.
35. Nixdorf DR, John MT, Wall MM, Fricton JR, Schiffman EL. Psychometric properties of the modified Symptom Severity Index (SSI). J Oral Rehabil.
36. Zhao NN, Evans RW, Byth K, Murray GM, Peck CC. Development and validation of a screening checklist for temporomandibular
disorders. J Orofac Pain.
37. Sugisaki M, Kino K, Yoshida N, Ishikawa T, Amagasa T, Haketa T. Development of a new questionnaire to assess pain-related limitations of daily functions in Japanese patients with temporomandibular
disorders. Community Dent Oral Epidemiol.
38. Aggarwal V, Zakrewska J, Macfarlane G, Macfarlane TV. Development and validation of the Manchester orofacial pain disability scale. Community Dent Oral Epidemiol.
39. Visscher CM, Ohrbach R, van Wijk AJ, Wilkosz M, Naeije M. The Tampa Scale for Kinesiophobia for Temporomandibular
Disorders (TSK-TMD). Pain.
40. Brister H, Turner JA, Aaron LA, Mancl L. Self-efficacy is associated with pain, functioning, and coping in patients with chronic temporomandibular
disorder pain. J Orofac Pain.
41. Valle-Corotti K, Pinzan A, do Valle CV, Nahas AC, Corotti MV. Assessment of temporomandibular
disorder and occlusion in treated class III malocclusion patients. J Appl Oral Sci.
42. Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol.
43. Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health.
44. Steigerwald D. The Steigerwald/Maher TMD Disability Questionnaire. Today's Chiropractic.
45. Ness GM, Laskin DM. Global doctor opinion versus a patient questionnaire for the outcome assessment of treated temporomandibular
disorder patients. J Oral Maxillofac Surg.
48. Gonzalez-Iglesias J, Cleland JA, Neto F, Hall T, Fernandezde-las-Penas C. Mobilization with movement, thoracic spine manipulation, and dry needling for the management of temporomandibular
disorder: a prospective case series. Physiother Theory Pract.
49. Furto ES, Cleland JA, Whitman JM, Olson KA. Manual physical therapy interventions and exercise for patients with temporomandibular
50. Cleland J, Palmer J. Effectiveness of manual physical therapy, therapeutic exercise, and patient education on bilateral disc displacement without reduction- of the temporomandibular
joint: a single-case design. J Orthop Sports Phys Ther.
51. Khuman R, Chavda D, Surbala L, Chanundhary E, Bhatt U, Nambi G. Physical therapy in temporomandibular
dysfunction following maxillo-mandibular fixation in sub-condylar mandibular fracture-a single case study. Int J Health Sci Res.
52. Kanatas AN, Rogers SN. A systematic review of patient selfcompleted questionnaires suitable for oral and maxillofacial surgery. Br J Oral Maxillofac Surg.
53. Ojo B, Genden EM, Teng MS, Milbury K, Misiukiewicz KJ, Badr H. A systematic review of head and neck cancer
quality of life assessment instruments. Oral Oncol.
54. Spinelli BA, Galantino ML, Eden MM, Flores AM. Recommendations for patient-reported outcome measures for head and neck cancer
-related neck dysfunction: a systematic review. Rehabil Oncol.
55. Eden MM, Flores AM, Galantino ML, Spinelli BA. Recommendations for patient-reported outcome measures for head and neck cancer
-related shoulder dysfunction: a systematic review. Rehabil Oncol.
56. Guru K, Manoor UK, Supe SS. A comprehensive review of head and neck cancer
rehabilitation: physical therapy perspectives. Indian J Palliat Care.
57. Djan R, Penington A. A systematic review of questionnaires to measure the impact of appearance on quality of life for head and neck cancer
patients. J Plast Reconstr Aesthet Surg.
58. Flores AM, Spinelli BA, Eden MM, Galantino ML. EDGE Task Force on Head and Neck Cancer
Outcomes: a systematic review of outcome measures for quantifying external lymphedema. Rehabil Oncol.
Keywords:©2015 (C) Academy of Oncologic Physical Therapy, APTA
temporomandibular; impairment; outcome measure; head and neck cancer