Evaluation of minimal important difference (MID) for the European organisation for research and treatment of cancer (EORTC) pancreatic cancer module (PAN26) in patients with surgically resected pancreatic adenocarcinoma

Reni, Michele; Braverman, Julia; Hendifar, Andrew Eugene; Li, C.-P.; Mercadé, T. Macarulla; Oh, Do‐Youn; Riess, Hanno; Tempero, Margaret A.; Lu, Brian; Marcus, James; Joshi, Nikita; Botterman, M.; Dueck, Amylou C.

doi:10.1093/annonc/mdz247.014

Cited by 4 publications

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“… 55 , 56 In addition, there were clinically significant improvements in the QLQ-PAN26 symptom scales for the supervised and home-based exercise groups, 45 including pancreatic pain (>8 pts), indigestion (>9 pts), and body image (>10 pts). 57 However, in the single-arm trial by Ngo-Huang et al 47 that used the Functional Assessment of Cancer Therapy–Hepatobiliary (FACT-Hep) questionnaire, no significant improvements were observed.…”

Section: Resultsmentioning

confidence: 99%

Exercise Medicine in the Management of Pancreatic Cancer

et al. 2021

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Section: Resultsmentioning

confidence: 99%

Exercise Medicine in the Management of Pancreatic Cancer

et al. 2021

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“…The MIC definitions were obtained by other authors carrying out observational studies [ 13 , 14 ] or using existing data from past clinical trials [ 15 ]. For the EORTC disease-specific modules (as opposed to the core instrument) initial studies investigating MIDs or MICs have been published [ 16 , 17 ]. It is our aim to calculate MID and MIC estimates for the recently updated head and neck module, the EORTC QLQ-HN43 [ 18 – 20 ].…”

Section: Introductionmentioning

confidence: 99%

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

Schnittger¹,

Tomaszewska

Amdal

et al. 2021

Qual Life Res

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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.

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“…The MIC de nitions were obtained by other authors carrying out observational studies [13,14] or using existing data from past clinical trials [15]. For the EORTC disease-speci c modules (as opposed to the core instrument) initial studies investigating MIDs or MICs have been published [16,17]. It is our aim to calculate MID and MIC estimates for the recently updated head and neck module, the EORTC QLQ-HN43 [18][19][20].…”

Section: Introductionmentioning

confidence: 99%

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

Schnittger¹,

Tomaszewska

Amdal

et al. 2021

Preprint

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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.

show abstract

Evaluation of minimal important difference (MID) for the European organisation for research and treatment of cancer (EORTC) pancreatic cancer module (PAN26) in patients with surgically resected pancreatic adenocarcinoma

Cited by 4 publications

References 0 publications

Exercise Medicine in the Management of Pancreatic Cancer

Exercise Medicine in the Management of Pancreatic Cancer

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

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

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