Evidence map›Paper›PMID 34272632›Full record

ArticleQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2022

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.

Susanne Singer, Eva Hammerlid, Iwona M Tomaszewska, Cecilie Delphin Amdal, Kristin Bjordal, Bente Brokstad Herlofson, Marcos Santos, Joaquim Castro Silva, Hisham Mehanna, Amy Fullerton and 22 more

Abstract readMulticenter Study
In one paragraph

Article in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Responsiveness and clinical utility of patient-reported outcome instruments in head and neck cancer: a systematic review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026
    Pooled it
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  8. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

32 authors.

Susanne SingerDivision of Epidemiology and Health Services Research, Institute of Medical Biostatistics, Epidemiology, and Informatics (IMBEI), University Medical Centre of Johannes Gutenberg University, Obere Zahlbacher Straße 69, 55131, Mainz, Germany. singers@uni-mainz.de.ORCID http://orcid.org/0000-0001-5784-7964
Eva HammerlidDepartment of Otorhinolaryngology-Head and Neck Surgery, Institute of Clinical Sciences, Sahlgrenska Academy At University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.ORCID http://orcid.org/0000-0002-1813-108X
Iwona M TomaszewskaDepartment of Medical Didactics, Jagiellonian University Medical College, Krakow, Poland.ORCID http://orcid.org/0000-0002-4118-5596
Cecilie Delphin AmdalDepartment of Oncology, Oslo University Hospital, Oslo, Norway.ORCID http://orcid.org/0000-0001-8422-8085
Kristin BjordalDepartment of Oncology, Oslo University Hospital, Oslo, Norway.ORCID http://orcid.org/0000-0002-1914-494X
Bente Brokstad HerlofsonDepartment of Oral Surgery and Oral Medicine, University of Oslo, Oslo, Norway.ORCID http://orcid.org/0000-0002-9621-9263
Marcos SantosRadiation Oncology Department, Grupo CONFIAR, Goiania, GO, Brazil.ORCID http://orcid.org/0000-0002-7055-4397
Joaquim Castro SilvaDepartment of Otolaryngology, Head and Neck Surgery, Instituto Português de Oncologia Francisco Gentil Do Porto, Porto, Portugal.ORCID http://orcid.org/0000-0002-3934-9950
Hisham MehannaInstitute of Head and Neck Studies and Education, University of Birmingham, Birmingham, UK.ORCID http://orcid.org/0000-0002-5544-6224
Amy FullertonDepartment of Communication Sciences and Disorders, Brooks Rehabilitation College of Healthcare Sciences, Jacksonville University, Jacksonville, FL, USA.ORCID http://orcid.org/0000-0002-4336-5523
Christine BrannanLynda Jackson Macmillan Centre, East & North Hertfordshire NHS Trust Incorporating Mount Vernon Cancer Centre, Northwood, UK.ORCID http://orcid.org/0000-0002-7177-2396
Loreto Fernandez GonzalezInstituto Oncologico Fundación Arturo Lopez Perez, Santiago, Chile.ORCID http://orcid.org/0000-0001-5026-6438
Johanna InhesternDepartment of Otorhinolaryngology, Oberhavelkliniken, Hennigsdorf, Germany.ORCID http://orcid.org/0000-0003-4613-2810
Monica PintoStrategic Health Services Department, Istituto Nazionale Tumori -IRCCS- Fondazione G. Pascale, Napoli, Italy.ORCID http://orcid.org/0000-0002-0823-4907
Juan I ArrarasOncology Departments, Complejo Hospitalario de Navarra, Pamplona, Spain.ORCID http://orcid.org/0000-0002-4415-2570
Noam YaromOral Medicine Unit, Sheba Medical Center, Tel-Hashomer, Israel.ORCID http://orcid.org/0000-0001-9771-7857
Pierluigi BonomoRadiation Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, Italy.
Ingo BaumannDepartment of Otolaryngology, Head and Neck Surgery, University of Heidelberg, Heidelberg, Germany.
Razvan GalalaeMedAustron, Vienna, Austria.ORCID http://orcid.org/0000-0001-8800-5460
Ourania Nicolatou-GalitisDental Oncology Unit, Clinic of Hospital Dentistry, School of Dentistry, National and Kapodistrian University of Athens, Athens, Greece.ORCID http://orcid.org/0000-0001-9036-6329
Naomi KiyotaDepartment of Medical Oncology and Hematology, Kobe University Hospital Cancer Center, Kobe, Japan.ORCID http://orcid.org/0000-0001-8021-6116
Judith Raber-DurlacherDepartment of Oral and Maxillofacial Surgery, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.ORCID http://orcid.org/0000-0003-1500-8390
Dina SalemDepartment of Medical Oncology, Ain Shams-University, Cairo, Egypt.ORCID http://orcid.org/0000-0001-9281-0999
Alexander FabianDepartment of Radiation Therapy, University Hospital Schleswig-Holstein, Kiel, Germany.ORCID http://orcid.org/0000-0003-2415-527X
Andreas BoehmDepartment of Otolaryngology Head and Neck Surgery, St. Georg Hospital, Leipzig, Germany.ORCID http://orcid.org/0000-0001-9511-9167
Sanja Krejovic-TrivicClinic of Otorhinolaryngology and Maxillofacial Surgery, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
Wei-Chu ChieInstitute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taiwan, Taiwan.ORCID http://orcid.org/0000-0001-5584-6554
Katherine TaylorDivision of Epidemiology and Health Services Research, Institute of Medical Biostatistics, Epidemiology, and Informatics (IMBEI), University Medical Centre of Johannes Gutenberg University, Obere Zahlbacher Straße 69, 55131, Mainz, Germany.ORCID http://orcid.org/0000-0003-0768-5789
Christian SimonDepartment of Otolaryngology, Lausanne, Switzerland.ORCID http://orcid.org/0000-0002-4156-9143
Lisa LicitraDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milano, Italy.ORCID http://orcid.org/0000-0003-0623-4118
Allen C ShermanBehavioral Medicine Division, Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences, Little Rock, USA.ORCID http://orcid.org/0000-0001-5457-1659
EORTC Quality of Life Group and the EORTC Head and Neck Cancer Group

Funding

European Organisation for Research and Treatment of Cancer 001/2014
6 · The paper itself

Abstract

purposeThe 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.

methodsIn 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.

resultsFrom 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.

conclusionsFor 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.

Indexed as

DeglutitionHead and Neck NeoplasmsHumansQuality of LifeSurveys and QuestionnairesClinical significanceEORTC QLQ-HN43MCIDMinimal important changeMinimal important differenceSubjective significance

Identifiers

PMID34272632
PMCPMC8921167

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.