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1 This is an author produced version of an article that appears in: HEAD AND NECK The definitive version is available at: Published text: R C Dwivedi, S St Rose, J W Roe, E Chisholm, B Elmiyeh, C M Nutting, P M Clarke, C J Kerawala, P H Rhys-Evans, K J Harrington, R Kazi (2010) First report on the reliability and validity of speech handicap index in native English-speaking patients with head and neck cancer, Head and Neck Institute of Cancer Research Repository Please direct all s to: publications@icr.ac.uk

2 First report on the Reliability and Validity of Speech Handicap Index (SHI) in Native English-speaking Head and Neck Cancer Patients Authors: Raghav C. Dwivedi, MRCS, DOHNS, MS 1,2 ; Suzanne St. Rose, PhD 1,3 ; Justin W.G. Roe, MSc. Cert. MRCSLT 1,2 ; Edward Chisholm, MRCS, MD 1 ; Behrad Elmiyeh, MRCS, DOHNS 1 ; Christopher M. Nutting, FRCR 1,2 ; Peter M. Clarke, FRCS 1 ; Cyrus J. Kerawala, FRCS, FDSRCS 1,2 ; Peter H. Rhys-Evans, FRCS 1,2 ; Kevin J. Harrington, FRCR, PhD 1,2 ; Rehan Kazi, MS, FRCS 1,2 Affiliations: 1 Head and Neck Unit, Royal Marsden Hospital, Fulham Road, London, SW3 6JJ, UK. 2 The Institute of Cancer Research, 123 Old Brompton Road, London SW7 3RP, UK. 3 Department of Statistics, Royal Marsden Hospital, Fulham Road, London, SW3 6JJ, UK Address for correspondence: Dr. Raghav Dwivedi Head and Neck Unit Royal Marsden Hospital Fulham Road, London, SW3 6JJ, UK Ph: ; raghav_dwivedi@rediffmail.com Funding and financial support Dr. Raghav Dwivedi, Dr. Rehan Kazi and Mr. Justin Roe are supported by Research Grants from the Head and Neck Cancer Research Trust/ The Oracle Cancer Trust. Acknowledgement: The authors would like to thank Mr. Rico N. Rinkel, Department of Otolaryngology- Head and Neck Surgery, VU University Medical Center, Amsterdam, The Netherlands and Prof. Adrian Fourcin, Department of Phoniatrics and Linguistics, University College London, UK for their continuous support and encouragement for this study. Running title: Validation of English Version of Speech Handicap Index Key words: Speech Handicap Index (SHI); Head and neck cancer; Oral cancer; Oropharyngeal cancer; Quality of life. 1

3 Abstract: Background Post-treatment speech problems are seen in nearly half of head and neck cancer patients. Although there are many voice-specific scales, surprisingly there is no speech-specific questionnaire for English-speaking head-neck cancer patients. The aim of this study was to validate the Speech Handicap Index (SHI) as the first speech-specific questionnaire in the English language. Method Fifty-five consecutive patients in follow-up for oral and oropharyngeal cancer completed the SHI and University of Washington Quality of Life Questionnaire (UWQOL V.04). Thirty-two patients completed both questionnaires again four weeks later to address testretest reliability. Results Internal consistency, test-retest reliability, construct validity and group validity of the SHI were found to be highly significant (P<0.01) using Cronbach s alpha, Spearman s correlation coefficient and Mann-Whitney U-tests. Conclusion The SHI is a precise, highly reliable and valid speech assessment tool for head-neck cancer patients. Further dedicated studies using the SHI in head-neck cancer patients would be useful. 2

4 Introduction: Head and neck cancer per se and its treatment may negatively affect patient's functional status and quality of life. 1-6 Patients often report speech deterioration, swallowing difficulties and facial appearance changes which may ultimately result in psycho-social problems Nowhere else is this more obvious than in cancers involving the oral cavity and oropharynx. 1,2 The presence of post-treatment speech problems in patients with oral and oropharyngeal cancers has been well documented in the literature by both prospective and retrospective studies According to recent estimates, nearly 50% of oral and oropharyngeal cancer patients encounter speech problems in their day-to-day life, 2 which is not surprising as the tumor and its treatment often has a detrimental impact on the functioning of important speech articulators (tongue, alveolar ridge, hard and soft palate and floor of mouth) in the oral cavity and the oropharynx. 1 Timely detection of post-treatment speech problems and their appropriate rehabilitation is vital in providing a good functional QOL to these patients. 1,13 Evaluation of patient s speech can be undertaken by either subjective methods or objective speech analysis techniques. 1,30 Easiest and most commonly used methods are subjective speech evaluation by using patient self-rated health-related QOL questionnaires (HRQOL). 1,31 These can be general, disease-specific or symptom/function-specific QOL questionnaires. 1,31 To date, there are over 1000 instruments available for measuring health-related QOL in patients. 31 Some commonly used head-neck cancer -specific questionnaires are University of Washington QOL (UWQOL), European Organization for Research and Treatment of Cancer head-neck 3

5 module (EORTC-HN) and Functional Assessment of Cancer Therapy head neck module (FACT-HN). 1,31 Examples of symptom/function-specific questionnaires commonly used in HNC patients are Performance Status Scale (PSS), MD Anderson Dysphagia Inventory (MDADI) and Swallowing Quality of Life Questionnaire (SWAL-QOL) for swallow assessment and Voice Handicap Index (VHI) and Voice Related QOL (VRQOL) for voice assessment. 1,31 Although numerous voice-specific scales exist for use in the literature, there is no speech-specific questionnaire available for English-speaking headneck cancer patients 1. It is important to distinguish between voice and speech; voice is a laryngeal function while speech is the final end-product of complex interplay between vocal tract articulators, hence requires specific assessment tools. 1 The first speechspecific questionnaire, the Speech Handicap Index (SHI) was developed and validated in the Dutch language by Rinkel et al 2 in the latter half of Our work aims at filling this gap by validating for the first time the SHI for English-speaking head-neck cancer patients. Materials and methods: Patients Following local research ethics committee approval, sixty-three consecutive Englishspeaking patients in follow-up for oral or oropharyngeal cancers at The Royal Marsden Hospital, London, UK were recruited for this study. All patients had received curative treatment in the form of surgery (with or without chemo-radiotherapy). Patients with end-stage disease, other associated malignancies or any diagnosed neuromuscular disease known to affect speech function were excluded from the study. Tracheostomised patients, 4

6 patients within the first six months of initial treatment and those over 80 years of age were also excluded from the study. Questionnaires The development of the Dutch version of the Speech Handicap Index (SHI) was largely based on the widely used and popular voice-specific scale the Voice Handicap Index (VHI) 32 by Rinkel et al. 2 Consequently, our English version of SHI (Appendix) is on the same lines. 32 It has 30 well-constructed questions to evaluate the patient s speech and psycho-social functions. These questions were adapted from the original manuscript of the development and validation of the Dutch version of the SHI. Here the questions were translated and then back-translated by expert professional translators to ensure that words and nuances are correctly matched as was confirmed by the Dutch group. Our English version of the SHI is based on a Likert five- point scale with response categories as never (0); almost never (1); sometimes (2); almost always (3) and always (4). Total SHI score is calculated by adding all the response numbers and can range from 0-120; higher scores indicate more severe speech-related problems. In addition to these 30 questions, there is a global question which rates the patient s overall speech quality. Here there are four response categories: excellent; good; average and bad which are scored as 0, 30, 70 and 100. Higher scores again indicate a greater speech problem. For the purpose of validity, we have utilized the UWQOL V.04 as a comparative QOL scale. This is a validated, widely-used, self-administered head and neck cancer-specific questionnaire with 12 domains for evaluation, speech being one of them. Other domains included are pain, appearance, activity, recreation, swallowing, chewing, shoulder 5

7 function, taste, saliva, mood and anxiety. 33,34 Here speech is evaluated by a single question based on a Guttman four- point scale and scored as 0, 30, 70 and 100. Higher scores indicate better speech function. UWQOL social function score is computed as the simple average of 6 domains (anxiety, mood, pain, activity, recreation and shoulder function). Administration of questionnaire Patients were given the SHI and UWQOL questionnaires in the outpatient clinic with a personalized covering letter explaining briefly the purpose of the study. In addition, the questionnaires and the purpose of study were also explained (face-to-face) to each patient. The patients were requested to complete both scales within 24 hours of each other and return the questionnaires via post. A randomly selected subset of thirty-two patients was asked to complete both the questionnaires (SHI & UWQOL) again after four weeks in order to assess test-retest reliability. Statistical analysis Demographic and treatment details of all patients were extracted from the medical records and the data were entered in to a worksheet (Excel 05; Microsoft Corp., WA, USA). Questionnaire data were also entered in the worksheet for the purpose of analysis. Analysis was performed using the commercially available Statistical Package for Social Sciences-15 statistical software (SPSS Inc., Chicago, IL, USA). Questionnaire data were then subjected to reliability and validity assessment. 6

8 Reliability Both the internal consistency and test-retest reliability were measured in this study. Internal consistency and test-retest reliability were determined using Cronbach s alpha coefficient and Spearman s rank correlation coefficient, respectively. A high Cronbach s alpha (>0.70) and Spearman s correlation (rho > 0.60) value indicates adequate internal consistency and test-retest reliability. 35 Validity Construct and group validity were assessed by correlating speech item score with related constructs from the UWQOL questionnaire. Bench marks for evaluating correlation values are >0.60: strong correlation; 0.40 to 0.60: moderate to substantial correlation; <0.40: weak correlation. 36 Group validity based on tumor sites, stage, duration of followup, co-morbidity and sex was also evaluated using Mann-Whitney U-test. The level of significance was set at P<0.05. Content validity or face validity was established by evaluation of substantive content by a common consensus process in a multidisciplinary team setting comprising of head-neck cancer experts and most importantly patients themselves. This was not possible for criterion or concurrent validity as there is no other existing speech-specific questionnaire available in the literature for use. Results: Patient characteristics We received adequately completed questionnaires from fifty-five of the sixty-three oral and oropharyngeal cancer patients identified for the study, thus providing a response rate 7

9 of 87%. The median age of the group was 59.4 years (range: ) with 36 males and 19 females. Detailed patient characteristics are provided in Table 1. Briefly, 17 (30.9%) patients had cancer of the oral cavity while 38 (69.1) patients had oropharyngeal cancer. Reliability Internal consistency The internal consistency reliability for Total SHI (mean of all 30 questions) and SHI speech domain (mean of 14 questions specific for evaluation of speech functions) as calculated by Cronbach s alpha coefficient was 0.98 and 0.95, respectively. For SHI psycho-social domain (mean of 14 questions specific for evaluation of psycho-social function) Cronbach s alpha coefficient was (Table 2) Test-retest reliability Test-retest reliability of Total SHI and SHI speech domain as calculated by Spearman s rank correlation coefficient were 0.92 and 0.88, respectively. For SHI psycho-social domain the coefficient was (Table 3). Test-retest reliability of additional SHI question assessing overall speech quality was Validity Construct validity To assess convergent construct validity and to determine the extent to which hypothetical relationships are confirmed 35, we compared Total SHI values and values of speech and 8

10 psychosocial domains of SHI with speech and social assessment domains of the UWQOL questionnaire using Spearman s rank correlation coefficients. The correlation between Total SHI score, the SHI speech domain, the SHI psycho-social domain and overall SHI speech assessment question, and speech domain of UWQOL were 0.72, 0.72, 0.71 and 0.68, respectively (Table 4). The correlations between Total SHI score, the SHI speech domain, the SHI psycho-social domain and overall SHI speech assessment question, and social domain of the UWQOL were 0.44, 0.44, 0.43 and 0.35, respectively (Table 4). Group validity To determine the ability of the SHI to detect differences in groups of patients who were expected to be functioning at different levels, we performed a group validity test using Mann-Whitney U-test. Significant differences (P<0.05) were detected when patients were grouped according to tumor sites, duration of follow-up, T stage, co-morbidity and gender (Table 5). Discussion: There exist many validated and widely used voice-specific scales in the literature. However, to date there are no speech specific questionnaires available to diagnose and quantify speech impairment in English-speaking head-neck cancer patients. We know that speech and voice are two distinct entities, with voice being purely a laryngeal function while speech is the end result which in addition has specific characteristics 9

11 imparted by the articulators in the vocal tract. 1 Therefore use of voice evaluation tools for evaluating speech outcome is not scientifically justified as the results will not represent or reflect what is intended to be measured. 1 Also the use of general or disease-specific QOL questionnaires for evaluating speech outcomes in head-neck cancer patients is not advisable as they are not sensitive enough utilizing only one or two questions to assess speech. 1 Reliability refers to the extent to which a test score is free from errors of measurement The importance of rigorously establishing reliability translates into accurate detection of change as a result of change in clinical status. The two most commonly used measures of reliability are internal consistency and test-retest reliability. 37,38 Internal consistency is useful in the construction of new scales or questionnaires and measures the inconsistency or non-equivalence of different questions intended to measure the same concept. 35 We have used alpha reliability which is similar to the split-half approach to measure consistency except that all possible ways of splitting and comparing sets of questions used to tap a particular concept are performed Cronbach s alpha is the measure of the alpha coefficient. 36,41,42 The value, which can vary from 0.0 to 1.0, represents how well a set of items measures the same underlying dimension. 35 Cronbach s alpha values that are between 0.70 and 0.90 suggest that the scale has adequate internal consistency. 36 We found SHI to have a high Cronbach s alpha coefficients for Total SHI, SHI speech domain and SHI psycho-social domains which is indicative that the questionnaire was consistent and addressed the same concept reliably. It is assumed that a measure with limited reliability will not provide a stable score across time. Test-retest reliability is a 10

12 measure to estimate that the construct or dimension being assessed is stable over time. The values of Total SHI scores, SHI speech domain, SHI psycho-social domain and overall speech quality were found to be highly significant by using Spearman s rank correlation coefficient. Validity is often seen as the most important consideration in evaluation of a measure. 37,38 However, it must be remembered here that validity does not refer to any inherent characteristic of the measure; measures themselves are never valid or invalid. 37 Although several types of validity have been described in the literature, the most common and important types are construct validity, group validity, content validity and criterion validity. 35 Construct validity refers to the extent to which a measure assesses the specific domain or construct of interest. 35 A widely used method of assessing construct validity is to examine how hypothetical relationships are confirmed. Therefore, the more often the hypothetical relationships are confirmed, the greater the construct validity of the survey variables is assumed to be. 41,42 Different domains of SHI were compared with similar domains of the existing standard, validated UWQOL questionnaire with the help of Spearman s rank correlation coefficient. Total SHI score, the SHI speech domain, the SHI psycho-social domain and overall SHI speech assessment question and speech domain of UWQOL were found to be highly significant. The correlations between Total SHI score, the SHI speech domain, the SHI psycho-social domain and overall SHI speech assessment question and social domain of UWQOL showed moderate correlation. The relatively low values of SHI psycho-social domain when compared with social domain of UWQOL may be because of incorporation of two grossly different sub-domains (pain 11

13 and shoulder functions) to calculate social domain scores of UWQOL. Group validity refers to the ability of the questionnaire or tool to be able to detect differences in groups of patients who were expected to be functioning at different levels. 36 The SHI was able to differentiate between groups of patients assumed to have different magnitudes of speech impairment. Some values in group analysis were found to be insignificant, probably because of smaller sample size or differences in patient characteristics, detailed analysis of which is currently ongoing in the department. Content validity or face validity precisely refers to how well the questions represent what is trying to be asked from the theoretical framework It is most often determined by the use of expert judgments and is an integral part of developing any psychometric tool. 35 Though we did not develop the questionnaire, but still as a part of consensus process, every single question was discussed and debated in multidisciplinary team setting comprising experienced head and neck cancer specialists, speech and language therapists with over 10 years of experience in managing head and neck cancer patients and most importantly patients as well. No items of the questionnaire were flagged by the subjects and experts as inappropriate or unclear. Criterion or concurrent validity serves to establish whether the new survey instrument accurately reflects the attitudes of a previously used gold-standard measure of the same concept. Since there is no other speech-specific questionnaire in the literature with which SHI can be compared, criterion validity was not assessable. The English language version of SHI has shown high values of reliability and validity scores which are parallel to the Dutch version, 2 indicating it to be a good tool for evaluating the impact of speech impairment in head-neck cancer patients. Patients can 12

14 easily complete it while waiting for their turn to come in the outpatient department. The results can be quickly calculated and documented in the patient records and if any speech impairment is found, it can be addressed - possibly at the same visit. Patients can also be given feedback on their speech rehabilitative efforts in a temporal manner which will help them to intensify, continue or decrease their efforts in order to get better speech. We think this tool will be an effective adjunct in the rehabilitation of head-neck cancer patients. Conclusion: In this study the SHI proved to be a valid and reliable tool for outcome assessment of speech problems in oral and oropharyngeal cancer patients. It is a precise, reliable and validated speech questionnaire which can be used in outpatient clinics to assess the nature and severity of a patient s complaints. Since it is a new tool, further studies are required to establish its usefulness in assessing speech impairment in head-neck cancer patients. Conflict of interest None to declare. Appendix: Speech Handicap Index (SHI) English version (for clinical research and patient use). 13

15 References: 1. Dwivedi RC, Kazi RA, Agrawal N, et al. Evaluation of speech outcomes following treatment of oral and oropharyngeal cancers. Cancer Treat Rev. 2009;35(5): Rinkel RN, Leeuw IM, van Reij EJ, Aaronson NK, Leemans CR. Speech handicap index in patients with oral and pharyngeal cancer: better understanding of patients complaints. Head Neck 2008;30(7): Karnell LH, Funk GF, Hoffman HT. Assessing head and neck cancer patient outcome domains. Head Neck. 2000;22(1): Borggreven PA, Verdonck-de Leeuw I, Langendijk JA, et al. Speech outcome after surgical treatment for oral and oropharyngeal cancer: a longitudinal assessment of patients reconstructed by a microvascular flap. Head Neck 2005;27(9): Zuydam AC, Lowe D, Brown JS, Vaughan ED, Rogers SN. Predictors of speech and swallowing function following primary surgery for oral and oropharyngeal cancer. Clin Otolaryngol 2005;30(5): Perry AR, Shaw MA, Cotton S. An evaluation of functional outcomes (speech, swallowing) in patients attending speech pathology after head and neck cancer treatment(s): results and analysis at 12 months post-intervention. J Laryngol Otol 2003;117(5): Ackerstaff AH, Lindeboom JA, Balm AJ, Kroon FH, Tan IB, Hilgers FJ. Structured assessment of the consequences of composite resection. Clin Otolaryngol 1998; 23:

16 8. De Boer MF, Pruyn JF, van den Borne B, Knegt PP, Ryckman RM, Verwoerd CD. Rehabilitation outcomes of long-term survivors treated for head and neck cancer. Head Neck 1995; 17: De Boer MF, McCormick LK, Pruyn JF, Rijckman RM, van den Borne BW. Physical and psychosocial correlates of head and neck cancer: a review of the literature. Otolaryngol Head Neck Surg 1999; 120: Hammerlid E, Ahlner-Elmqvist M, Bjordal K, et al. A prospective multicentre study in Sweden and Norway of mental distress and psychiatric morbidity in head and neck cancer patients. Br J Cancer 1999; 80: Logemann JA, Pauloski BR, Rademaker AW, Colangelo LA. Speech and swallowing rehabilitation for head and neck cancer patients. Oncology (Huntingt) 1997; 11: Seikaly H, Rieger J, Wolfaardt J, Moysa G, Harris J, Jha N. Functional outcomes after primary oropharyngeal cancer resection and reconstruction with the radial forearm free flap. Laryngoscope 2003;113(5): Furia CL, Kowalski LP, Latorre MR, et al. Speech intelligibility after glossectomy and speech rehabilitation. Arch Otolaryngol Head Neck Surg 2001;127(7): Borggreven PA, Verdonck-de Leeuw IM, Muller MJ, et al. Quality of life and functional status in patients with cancer of the oral cavity and oropharynx: pretreatment values of a prospective study. Eur Arch Otorhinolaryngol 2007;264(6):

17 15. Colangelo LA, Logemann JA, Rademaker AW. Tumor size and pretreatment speech and swallowing in patients with resectable tumors. Otolaryngol Head Neck Surg 2000;122(5): Hahn TR, Krüskemper G. The impact of radiotherapy on quality of life a survey of 1411 patients with oral cancer. Mund Kiefer Gesichtschir 2007;11(2): Morton RP. Studies in the quality of life of head and neck cancer patients: results of a two-year longitudinal study and a comparative cross-sectional cross-cultural survey. Laryngoscope 2003;113(7): Nicoletti G, Soutar DS, Jackson MS, Wrench AA, Robertson G. Chewing and swallowing after surgical treatment for oral cancer: functional evaluation in 196 selected cases. Plast Reconstr Surg 2004;114(2): Nijdam WM, Levendag PC, Noever I, Schmitz PI, Uyl-de Groot CA. Longitudinal changes in quality of life and costs in long-term survivors of tumors of the oropharynx treated with brachytherapy or surgery. Brachytherapy 2008;7(4): Rieger J, Dickson N, Lemire R, et al. Social perception of speech in individuals with oropharyngeal reconstruction. J Psychosoc Oncol 2006;24(4): Rieger JM, Zalmanowitz JG, Li SY, et al. Functional outcomes after surgical reconstruction of the base of tongue using the radial forearm free flap in patients with oropharyngeal carcinoma. Head Neck 2007;29(11): Rogers SN, Lowe D, Fisher SE, Brown JS, Vaughan ED. Health-related quality of life and clinical function after primary surgery for oral cancer. Br J Oral Maxillofac Surg 2002;40(1):

18 23. Seikaly H, Rieger J, O Connell D, Ansari K, Alqahtani K, Harris J. Beavertail modification of the radial forearm free flap in base of tongue reconstruction: technique and functional outcomes. Head Neck. 2009;31(2): Suarez-Cunqueiro MM, Schramm A, Schoen R, et al. Speech and swallowing impairment after treatment for oral and oropharyngeal cancer. Arch Otolaryngol Head Neck Surg 2008;134(12): Vartanian JG, Carvalho AL, Yueh B, Priante AV, et al. Long-term quality-of-life evaluation after head and neck cancer treatment in a developing country. Arch Otolaryngol Head Neck Surg 2004;130(10): Villaret AB, Cappiello J, Piazza C, Pedruzzi B, Nicolai P. Quality of life in patients treated for cancer of the oral cavity requiring reconstruction: a prospective study. Acta Otorhinolaryngol Ital 2008;28(3): Bozec A, Poissonnet G, Chamorey E, et al. Free-flap head and neck reconstruction and quality of life: a 2-year prospective study. Laryngoscope 2008;118(5): Malone JP, Stephens JA, Grecula JC, Rhoades CA, Ghaheri BA, Schuller DE. Disease control, survival, and functional outcome after multimodal treatment for advanced-stage tongue base cancer. Head Neck 2004;26(7): Pourel N, Peiffert D, Lartigau E, Desandes E, Luporsi E, Conroy T. Quality of life in long-term survivors of oropharynx carcinoma. Int J Radiat Oncol Biol Phys 2002;54(3):

19 30. Mlynarek AM, Rieger JM, Harris JR, et al. Methods of functional outcomes assessment following treatment of oral and oropharyngeal cancer: review of the literature. J Otolaryngol Head Neck Surg 2008;37(1): Kanatas AN, Rogers SN. A guide of the questionnaires used in the measurement of health-related quality of life in head and neck oncology. Tumori. 2008;94(5): Jacobson G, Johnson A, Grywalski C, et al. The Voice Handicap Index (VHI): development and validation. Am J Speech Lang Pathol 1997;6: Hassan SJ, Weymuller EA Jr. Assessment of quality of life in head and neck cancer patients. Head Neck. 1993;15(6): Weymuller EA Jr, Alsarraf R, Yueh B, Deleyiannis FW, Coltrera MD. Analysis of the performance characteristics of the University of Washington Quality of Life instrument and its modification (UW-QOL-R). Arch Otolaryngol Head Neck Surg. 2001;127(5): Kazi R, Singh A, De Cordova J, Al-Mutairy A, Clarke P, Nutting C, Rhys-Evans P, Harrington K. Validation of a voice prosthesis questionnaire to assess valved speech and its related issues in patients following total laryngectomy. Clin Otolaryngol. 2006;31(5): Chen AY, Frankowski R, Bishop-Leone J, Hebert T, Leyk S, Lewin J, Goepfert H. The development and validation of a dysphagia-specific quality-of-life questionnaire for patients with head and neck cancer: the M. D. Anderson dysphagia inventory. Arch Otolaryngol Head Neck Surg. 2001;127(7):

20 37. Jensen MP. Questionnaire validation: a brief guide for readers of the research literature. Clin. J. Pain 2003;19: Chen AY, Whigham AS. Validation of health status instruments. J. Otorhinolaryngol. Relat. Spec. 2004;66: Aday L. Designing and Conducting Health Surveys, 2 nd edn. Jossey-Bass/Pfeiffer, San Francisco, CA, p Nunnally JC, Bernstein IH. Psychometric Theory, 3rd edn. McGraw-Hill Education, New York, NY, p Terrell JE, Nanavati KA, Esclamado RM, et al. Head and neck cancer-specific quality of life: instrument validation. Arch. Otolaryngol. Head Neck Surg. 1997; 23: Young TL, Kirchdoerfer LJ, Osterhaus JT. A development and validation process for a disease-specific quality of life instrument. Drug Inf. J. 1996; 30: Table 1. Patient characteristics (N=55) Characteristic Number (%) Age Mean (range) 59 ( ); SD: 10.0 Median (interquartile range) 59.4 (51.2, 66.3) Sex Male 36 (65.5) Female 19 (34.5) Tumour location Oral cancer 17 (30.9) Oropharyngeal cancer 38 (69.1) 19

21 Tumour location (sub-site) Tongue 15 (27.3) Base of tongue 15 (27.3) Floor of mouth 2 (3.6) Tonsil 22 (40) Soft palate 1 (1.8) Clinical stage I 7 (12.7) II 5 (9.1) III 9 (16.4) IV 34 (61.8) T-stage T1 15 (27.3) T2 30 (54.5) T3 5 (9.1) T4 5 (9.1) N-stage N0 16 (29.1) N1 7 (12.7) N2 31 (56.4) N3 1 (1.8) Treatment Surgery 6 (10.9) Post-operative radiotherapy 27 (49.1) Post-operative chemoradiotherapy 22 (40.0) Glossectomy Yes 31 (56.4) No 24 (43.6) Comorbidity Yes 24 (43.6) No 31 (56.4) Follow-up (months) Mean (range) 78.1 ( ); SD:

22 Table 2 Reliability: Internal consistency Index/Domain Cronbach s alpha coefficient P-value Total SHI (N=30) 0.98 < Speech domain (N=14) 0.95 < Psycho-social domain (N=14) 0.98 < Note: A consistently high reliability coefficient (>0.70) indicates that index/domains asess the same or high-related constructs. Table 3 Reliability: Test-retest reliability (Based on Spearman s rank correlation coefficient and associated P-values) (N=32) Test \Retest Total SHI Speech domain Psycho-social domain Overall Total SHI 0.92 (P<0.0001) Speech domain (P<0.0001) - - Psycho-social domain (P<0.0001) - Overall (P<0.0001) 21

23 Table 4 Construct validity (Based on Spearman s rank correlation coefficient and associated P-values) (N=55) SHI UWQOL Speech domain Psycho-social domain Total SHI 0.72 (P<0.0001) 0.44 (P=0.001) Speech domain 0.72 (P<0.0001) 0.44 (P=0.001) Psycho-social domain 0.71 (P<0.0001) 0.43 (P=0.001) Overall SHI 0.68 (P<0.0001) 0.35 (P=0.01) Group characteristic Table 5 SHI: Group validity (Tests of differences between groups assessed using the Mann-Whitney U-test and associated P-values) (N=55). Numbe r Mean ranks Total SHI Speech domain Psycho-social domain Overall SHI P-value Mean P-value Mean P-value Mean P-value ranks ranks ranks Tumour location Oral * * ** Oropharyngeal Follow-up <2 years >2 years T-stage Early ** ** 24.4 <0.0001*** ** Late Comorbidity Yes * No Sex Male Female *P<0.05 **P<0.01 ***P<

24 Speech Handicap Index (SHI) English version Reg no: Name: Date: These are some statements that many people may have used to describe their speech and the effects of their speech on their lives. Please tick the response that indicates how frequently you have the same experience. SN Item Never Almost never 1 My speech makes it difficult for people to understand me Some times Almost always Always 2 I run out of air when I speak 3 The intelligibility of my speech varies throughout the day 4 My speech makes me feel incompetent 5 People ask me why I m hard to understand 6 I feel annoyed when people ask me to repeat 7 I avoid using the phone 8 I m tense when talking to others because of my speech 9 My articulation is unclear 10 People have difficulty understanding me in a noisy room 11 I tend to avoid groups of people because of my speech 12 People seem irritated with my speech 13 People ask me to repeat myself when speaking face-to face 14 I speak with friends and neighbors or relatives less often because of my speech 23

25 15 I feel as though I have to strain to speak 16 I find other people don t understand my speaking problem 17 My speaking difficulties restrict my personal and social life 18 The intelligibility is unpredictable 19 I feel left out of conversations because of my speech 20 I use a great deal of effort to speak 21 My speech is worse in the evening 22 My speech problem causes me to lose income 23 I try to change my speech to sound different 24 My speech problem upsets me 25 I am less outgoing because of my speech problem 26 My family has difficulty understanding me when I call them throughout the house 27 My speech makes me feel handicapped 28 I have difficulties to continue a conversation because of my speech 29 I feel embarrassed when people ask me to repeat 30 I m ashamed of my speech problem How do you rate your own speech at this moment (please circle the right answer)? Excellent Good Average Bad 24

26 Scoring of SHI Values for response categories; Never =0 Almost never=1 Some times=2 Almost always=3 Always=4 For calculation of total SHI score; Please add scores of all 30 questions. Total score range; For calculation of Speech domain; Please add scores of questions 1,2,3,5,6,9,10,13,15,18,20,21,26, and 28. For calculation of Speech domain; Please add scores of questions 4,7,8,11,12,14,16,17,19,24,25,27,29 and 30. Values for response categories for overall speech assessment question; Excellent=0 Good=30 Average=70 Bad=100 25

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