scholarly journals Methodological approach for determining the Minimal Important Difference and Minimal Important Change scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module (EORTC QLQ-HN43) exemplified by the Swallowing scale

Author(s):  
Susanne Singer ◽  
Eva Hammerlid ◽  
Iwona M. Tomaszewska ◽  
Cecilie Delphin Amdal ◽  
Kristin Bjordal ◽  
...  

Abstract Purpose The aim of this study was to explore what methods should be used to determine the minimal important difference (MID) and minimal important change (MIC) in scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43. Methods In an international multi-centre study, patients with head and neck cancer completed the EORTC QLQ-HN43 before the onset of treatment (t1), three months after baseline (t2), and six months after baseline (t3). The methods explored for determining the MID were: (1) group comparisons based on performance status; (2) 0.5 and 0.3 standard deviation and standard error of the mean. The methods examined for the MIC were patients' subjective change ratings and receiver-operating characteristics (ROC) curves, predictive modelling, standard deviation, and standard error of the mean. The EORTC QLQ-HN43 Swallowing scale was used to investigate these methods. Results From 28 hospitals in 18 countries, 503 patients participated. Correlations with the performance status were |r|< 0.4 in 17 out of 19 scales; hence, performance status was regarded as an unsuitable anchor. The ROC approach yielded an implausible MIC and was also discarded. The remaining approaches worked well and delivered MID values ranging from 10 to 14; the MIC for deterioration ranged from 8 to 16 and the MIC for improvement from − 3 to − 14. Conclusions For determining MIDs of the remaining scales of the EORTC QLQ-HN43, we will omit comparisons of groups based on the Karnofsky Performance Score. Other external anchors are needed instead. Distribution-based methods worked well and will be applied as a starting strategy for analyses. For the calculation of MICs, subjective change ratings, predictive modelling, and standard-deviation based approaches are suitable methods whereas ROC analyses seem to be inappropriate.

2021 ◽  
Author(s):  
Susanne Singer ◽  
Eva Hammerlid ◽  
Iwona M. Tomaszewska ◽  
Cecilie Delphin Amdal ◽  
Kristin Bjordal ◽  
...  

Abstract Purpose The aim of this study was to explore what methods should be used to determine the minimal important difference (MID) and minimal important change (MIC) in scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43.Methods In an international multi-centre study, patients with head and neck cancer completed the EORTC QLQ-HN43 before the onset of treatment (t1), three months after baseline (t2), and six months after baseline (t3). The methods explored for determining the MID were: 1) group comparisons based on performance status; 2) 0.5 and 0.3 standard deviation and standard error of the mean. The methods examined for the MIC were patients' subjective change ratings and receiver-operating characteristics (ROC) curves, predictive modelling, standard deviation, and standard error of the mean. The EORTC QLQ-HN43 Swallowing scale was used to investigate these methods.Results From 28 hospitals in 18 countries, 503 patients participated. Correlations with the performance status were |r|<0.4 in 17 out of 19 scales; hence, performance status was regarded as an unsuitable anchor. The ROC approach yielded an implausible MIC and was also discarded. The remaining approaches worked well and delivered MID values ranging from 10 to 14; the MIC for deterioration ranged from 8 to 16 and the MIC for improvement from -3 to -14.Conclusions For determining MIDs of the remaining scales of the EORTC QLQ-HN43, we will omit comparisons of groups based on the Karnofsky Performance Score. Other external anchors are needed instead. Distribution-based methods worked well and will be applied as a starting strategy for analyses. For the calculation of MICs, subjective change ratings, predictive modelling, and standard-deviation based approaches are suitable methods whereas ROC analyses seem to be inappropriate.


2009 ◽  
Vol 124 (4) ◽  
pp. 412-416 ◽  
Author(s):  
N B Oozeer ◽  
S Owen ◽  
B Z Perez ◽  
G Jones ◽  
A R Welch ◽  
...  

AbstractIntroduction:Total laryngectomy affects patients' post-operative speech and swallowing functions. We aimed to assess these outcomes.Materials and methods:Patients' normalcy of diet, ability to eat in public and speech comprehensibility were assessed using the Performance Status Scale for Head and Neck Cancer, in a cross-sectional survey of disease-free laryngectomees.Results and analysis:Seventy-nine laryngectomees (72 men and seven women), with a mean age of 64 years (range 37 to 96), were included. Mean scores were 81.6 (standard deviation 29.2) for normalcy of diet, 77.8 (standard deviation 30.2) for eating in public and 65.2 (standard deviation 23.5) for speech. Normalcy of diet achieved higher scores within six months of laryngectomy and remained stable. There was a statistically significant difference between scores for the speech and public eating domains, comparing patients less and more than six months post-laryngectomy. This trend was maintained beyond 12 months.Conclusions:In post-laryngectomy patients, Performance Status Scale for Head and Neck Cancer scores improved over time, especially those for the speech and public eating domains, reflecting increasing confidence in social interactions and familiarity with surgical voice restoration.


Author(s):  
Lars Axelsson ◽  
Erik Holmberg ◽  
Jan Nyman ◽  
Anders Högmo ◽  
Helena Sjödin ◽  
...  

Abstract Introduction Head and neck cancer of unknown primary (HNCUP) is a rare condition whose prognostic factors that are significant for survival vary between studies. No randomized treatment study has been performed thus far, and the optimal treatment is not established. Objective The present study aimed to explore various prognostic factors and compare the two main treatments for HNCUP: neck dissection and (chemo) radiation vs primary (chemo) radiation. Methods A national multicenter study was performed with data from the Swedish Head and Neck Cancer Register (SweHNCR) and from the patients' medical records from 2008 to 2012. Results Two-hundred and sixty HNCUP patients were included. The tumors were HPV-positive in 80%. The overall 5-year survival rate of patients treated with curative intent was 71%. Age (p < 0.001), performance status (p= 0.036), and N stage (p= 0.046) were significant factors for overall survival according to the multivariable analysis. Treatment with neck dissection and (chemo) radiation (122 patients) gave an overall 5-year survival of 73%, and treatment with primary (chemo) radiation (87 patients) gave an overall 5-year survival of 71%, with no significant difference in overall or disease-free survival between the 2 groups. Conclusions Age, performance status, and N stage were significant prognostic factors. Treatment with neck dissection and (chemo) radiation and primary (chemo) radiation gave similar survival outcomes. A randomized treatment study that includes quality of life is needed to establish the optimal treatment.


2000 ◽  
Vol 18 (4) ◽  
pp. 877-877 ◽  
Author(s):  
Marcy A. List ◽  
John Stracks ◽  
Laura Colangelo ◽  
Pamela Butler ◽  
Natasha Ganzenko ◽  
...  

PURPOSE: To determine, pretreatment, how head and neck cancer (HNC) patients prioritize potential treatment effects in relationship to each other and to survival and to ascertain whether patients’ preferences are related to demographic or disease characteristics, performance status, or quality of life (QOL). PATIENTS AND METHODS: One hundred thirty-one patients were assessed pretreatment using standardized measures of QOL (Functional Assessment of Cancer Therapy-Head and Neck) and performance (Performance Status Scale for Head and Neck Cancer). Patients were also asked to rank a series of 12 potential HNC treatment effects. RESULTS: Being cured was ranked top priority by 75% of patients; another 18% ranked it second or third. Living as long as possible and having no pain were placed in the top three by 56% and 35% of patients, respectively. Items that were ranked in the top three by 10% to 24% of patients included those related to energy, swallowing, voice, and appearance. Items related to chewing, being understood, tasting, and dry mouth were placed in the top three by less than 10% of patients. Excluding the top three rankings, there was considerable variability in ratings. Rankings were generally unrelated to patient or disease characteristics, with the exception that cure and living were of slightly lower priority and pain of higher priority to older patients compared with younger patients. CONCLUSION: The data suggest that, at least pretreatment, survival is of primary importance to patients, supporting the development of aggressive treatment strategies. In addition, results highlight individual variability and warn against making assumptions about patients’ attitudes vis-à-vis potential outcomes. Whether patients’ priorities will change as they experience late effects is currently under investigation.


PLoS ONE ◽  
2019 ◽  
Vol 14 (12) ◽  
pp. e0226077 ◽  
Author(s):  
Ann-Jean C. C. Beck ◽  
Jacobien M. Kieffer ◽  
Valesca P. Retèl ◽  
Lydia F. J. van Overveld ◽  
Robert P. Takes ◽  
...  

2017 ◽  
Vol 131 (5) ◽  
pp. 442-446 ◽  
Author(s):  
C Brammer ◽  
D Dawson ◽  
M Joseph ◽  
J Tipper ◽  
T Jemmet ◽  
...  

AbstractObjectives:This study aimed to assess head and neck cancer patient satisfaction with the use of a touch-screen computer patient-completed questionnaire for assessing Adult Co-morbidity Evaluation 27 co-morbidity scores prior to treatment, along with its clinical reliability.Methods:A total of 96 head and neck cancer patients were included in the audit. An accurate Adult Co-morbidity Evaluation 27 co-morbidity score was achieved via patient-completed questionnaire assessment for 97 per cent of participants.Results:In all, 96 per cent of patients found the use of a touch-screen computer acceptable and would be willing to use one again, and 62 per cent would be willing to do so without help. Patients were more likely to be willing to use the computer again without help if they were aged 65 years or younger (χ2test;p= 0.0054) or had a performance status of 0 or 1 (χ2test;p= 0.00034).Conclusion:Use of a touch-screen computer is an acceptable approach for assessing Adult Co-morbidity Evaluation 27 scores at pre-treatment assessment in a multidisciplinary joint surgical–oncology clinic.


2011 ◽  
Vol 20 (7) ◽  
pp. 1555-1564 ◽  
Author(s):  
Zheng Yang ◽  
Qiong Meng ◽  
Jiahong Luo ◽  
Qian Lu ◽  
Xiaojiang Li ◽  
...  

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 18572-18572
Author(s):  
D. V. Santos ◽  
K. M. Kiyota ◽  
I. Snitcovsky ◽  
G. M. Leitão ◽  
M. H. Federico

18572 Background: Head and neck cancer (HNC) is a stigmatizing disease. In order to identify special needs in these patients (pts), we evaluated HRQoL and the demographic characteristics of HNC pts who had survived at least one year after chemoradiation. Methods: Our survey, done in may 2005, identified 42 pts alive (from 527 admitted from May 2002 to May 2004 treated with either exclusive (n = 19) or adjuvant (n = 23) chemoradiation. These pts as well 16 normal controls, were interviewed and invited to complete EORTC-QLQ-C30 and HN35. These questionnaires had already been validated for Brazilian Portuguese. Primary site was 12 oral cavity, 14 pharynx, 13 larynx, 3 not determined. Age 60.3 ± 9.0 y, 36 male and 6 female; 39 were squamous cell carcinoma and 3 other type; 28 were stage III or IV; 40 had no evidence of disease and two had recurrent disease at the time of survey. Comparison between groups were done by using the Mann-Whitney test and differences of at least 10 points was considered of clinical significance. Simple correlations were conducted between HRQoL variables and clinical correlates and demographics. The level of significance was established at p < 0.05. This work was conducted according to Helsinki declaration and Brazilian law. Results: Scores relative to global QoL (p = 0.18) and emotional function (p = 0.59) did not differ in pts as compared to controls. Pts presented worse scores in swallowing, senses, speech, pain, dental problems, xerostomia and mouth opening (all p < 0.05). Emotional function (r = 0.316, p = 0.041) and financial worries (r = −0.509, p = 0.001) impacted on global QoL, what did not happen with marital status, income and level of education, age or previous surgery. Chronic pain was more prevalent in oral cavity tumors than in other sites such as pharynx or larynx tumors (p = 0.046 and p = 0.030, respectively). Pts with larynx tumors presented worse cough score as compared to those with pharynx tumors (p = 0.009). Conclusions: Providing continuous oral and dental care seems to be important to address survivors’ concerns. Financial distress could be ameliorated by a better social support system. Tumor site seem to affect differently some domains of HRQoL, in contrast to organ preservation. No significant financial relationships to disclose.


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