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

Schnittger, Susanne; Tomaszewska, Iwona M.; Amdal, Cecilie Delphin; Bjordal, Kristin; Herlofson, Bente Brokstad; Santos, Marcos; Silva, Joaquim Castro; Mehanna, Hisham; Fullerton, Amy; Brannan, Christine; González, Loreto Fernández; Inhestern, Johanna; Pinto, Monica; Arrarás, Juan Ignacio; Yarom, Noam; Bonomo, Pierluigi; Baumann, Ingo; Galalae, R.; Nicolatou‐Galitis, Ourania; Kiyota, Naomi; Raber-Durlacher, Judith E.; Salem, Dina; Fabian, Alexander; Boehm, Andreas; Krejović-Trivić, Sanja; Chie, Wei‐Chu; Taylor, Kathy; Simon, Christian; Licitra, Lisa; Sherman, Allen C.

doi:10.1007/s11136-021-02939-6

Cited by 9 publications

(8 citation statements)

References 42 publications

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“…Her EORTC QLQ-HN43 score that increased from 54 to 46 after surgery. This difference can be considered significant 14,15 . The patient self-reported quality of life, evaluated by the EuroQol Group-5 Dimensions Visual Analogue Scale (EQ-5D VAS), improved sharply between baseline (40/100) and two months after surgery (100/100), and remained unchanged at 12 months.…”

Section: Resultsmentioning

confidence: 99%

Total nasal reconstruction in irradiated tissue, a new hope

DUPRET-BORIES,

Chabrillac,

Poissonnet

et al. 2023

Preprint

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The 16th century expression "plain as the nose on one’s face" by Rabelais, used to refer to the obvious, reflects the paramount importance of the nose in a person's social life. However, total nasal reconstruction remains an unsolved surgical challenge. Through the case of a 50-year-old patient who lost her nose after cancer treatment, the authors present a total nasal reconstruction in two surgical steps using a novel and fully integrated 3D-printed biomaterial. In light of the surgical outcomes and the evolution of the patient's quality of life, this novel technique is a source of hope for many patients.

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Section: Resultsmentioning

confidence: 99%

Total nasal reconstruction in irradiated tissue, a new hope

DUPRET-BORIES,

Chabrillac,

Poissonnet

et al. 2023

Preprint

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“…Moreover, the 10-point difference is only a rough estimate with studies suggesting more fine-tuned scores may be preferable. [40][41][42][43] It is likely that survivors who were not doing well were less likely to agree to participate than those who function well, particularly because physical attendance at the clinic was part of the study. The lack of information about those who declined to participate and those who did not respond at all prevents us from understanding the extent of differences between participants and non-participants.…”

Section: Discussionmentioning

confidence: 99%

“…Using a 10‐point difference between the treatment groups based on the findings of Osoba et al is a reasonable choice, but we realize that while Osoba et al were looking for a minimally significant change, we have investigated a minimally significant difference. Moreover, the 10‐point difference is only a rough estimate with studies suggesting more fine‐tuned scores may be preferable 40–43 . It is likely that survivors who were not doing well were less likely to agree to participate than those who function well, particularly because physical attendance at the clinic was part of the study.…”

Section: Discussionmentioning

confidence: 99%

Long‐term health‐related quality of life in head and neck cancer survivors: A large multinational study

Taylor,

Amdal,

Bjordal

et al. 2024

Intl Journal of Cancer

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Head and neck cancer (HNC) patients suffer from a range of health‐related quality of life (HRQoL) issues, but little is known about their long‐term HRQoL. This study explored associations between treatment group and HRQoL at least 5 years' post‐diagnosis in HNC survivors. In an international cross‐sectional study, HNC survivors completed the European Organization for Research and Treatment of Cancer (EORTC) quality of life core questionnaire (EORTC‐QLQ‐C30) and its HNC module (EORTC‐QLQ‐H&N35). Meaningful HRQoL differences were examined between five treatment groups: (a) surgery, (b) radiotherapy, (c) chemo‐radiotherapy, (d) radiotherapy ± chemotherapy and neck dissection and (e) any other surgery (meaning any tumour surgery that is not a neck dissection) and radiotherapy ± chemotherapy. Twenty‐six sites in 11 countries enrolled 1105 survivors. They had a median time since diagnosis of 8 years, a mean age of 66 years and 71% were male. After adjusting for age, sex, tumour site and UICC stage, there was evidence for meaningful differences (10 points or more) in HRQoL between treatment groups in seven domains (Fatigue, Mouth Pain, Swallowing, Senses, Opening Mouth, Dry Mouth and Sticky Saliva). Survivors who had single‐modality treatment had better or equal HRQoL in every domain compared to survivors with multimodal treatment, with the largest differences for Dry Mouth and Sticky Saliva. For Global Quality of Life, Physical and Social Functioning, Constipation, Dyspnoea and Financial Difficulties, at least some treatment groups had better outcomes compared to a general population. Our data suggest that multimodal treatment is associated with worse HRQoL in the long‐term compared to single modality.

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“…The suggested MIC value of four is closer to the MIC value for improvement (3.9) than to the MIC value for deterioration (2.3) on anchor-based predictive modelling. It would be of great interest to explore this phenomenon further, which is not unique to FROM-16 [ 47 , 48 ]. Therefore, a future study, using a large sample, should establish whether there is a need for separate MIC values for improvement and deterioration.…”

Section: Discussionmentioning

confidence: 99%

Responsiveness and minimal important change of the Family Reported Outcome Measure (FROM-16)

Shah,

Finlay,

Salek

et al. 2024

J Patient Rep Outcomes

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Background The FROM-16 is a generic family quality of life (QoL) instrument that measures the QoL impact of patients’ disease on their family members/partners. The study aimed to assess the responsiveness of FROM-16 to change and determine Minimal Important Change (MIC). Methods Responsiveness and MIC for FROM-16 were assessed prospectively with patients and their family members recruited from outpatient departments of the University Hospital Wales and University Hospital Llandough, Cardiff, United Kingdom. Patients completed the EQ-5D-3L and a global severity question (GSQ) online at baseline and at 3-month follow-up. Family members completed FROM-16 at baseline and a Global Rating of Change (GRC) in addition to FROM-16 at follow-up. Responsiveness was assessed using the distribution-based (effect size-ES, standardized response mean -SRM) and anchor-based (area under the receiver operating characteristics curve ROC-AUC) approaches and by testing hypotheses on expected correlation strength between FROM-16 change score and patient assessment tools (GSQ and EQ-5D). Cohen’s criteria were used for assessing ES. The AUC ≥ 0.7 was considered a good measure of responsiveness. MIC was calculated using anchor-based (ROC analysis and adjusted predictive modelling) and distribution methods based on standard deviation (SD) and standard error of the measurement (SEM). Results Eighty-three patients with 15 different health conditions and their relatives completed baseline and follow-up questionnaires and were included in the responsiveness analysis. The mean FROM-16 change over 3 months = 1.43 (SD = 4.98). The mean patient EQ-5D change over 3 months = −0.059 (SD = 0.14). The responsiveness analysis showed that the FROM-16 was responsive to change (ES = 0.2, SRM = 0.3; p < 0.01). The ES and SRM of FROM-16 change score ranged from small (ES = 0.2; SRM = 0.3) for the distribution-based method to large (ES = 0.8, SRM = 0.85) for anchor-based methods. The AUC value was above 0.7, indicating good responsiveness. There was a significant positive correlation between the FROM-16 change scores and the patient’s disease severity change scores (p < 0.001). The MIC analysis was based on data from 100 family members of 100 patients. The MIC value of 4 was suggested for FROM-16. Conclusions The results of this study confirm the longitudinal validity of FROM-16 which refers to the degree to which an instrument is able to measure change in the construct to be measured. The results yield a MIC value of 4 for FROM-16. These psychometric attributes of the FROM-16 instrument are useful in both clinical research as well as clinical practice.

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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

Cited by 9 publications

References 42 publications

Total nasal reconstruction in irradiated tissue, a new hope

Total nasal reconstruction in irradiated tissue, a new hope

Long‐term health‐related quality of life in head and neck cancer survivors: A large multinational study

Responsiveness and minimal important change of the Family Reported Outcome Measure (FROM-16)

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