Minimal important differences and response shift in health-related quality of life; a longitudinal study in patients with multiple myeloma
Identifieur interne : 004C49 ( Main/Exploration ); précédent : 004C48; suivant : 004C50Minimal important differences and response shift in health-related quality of life; a longitudinal study in patients with multiple myeloma
Auteurs : Ann K. Kvam [Norvège] ; Finn Wisl Ff [Norvège] ; Peter M. Fayers [Royaume-Uni, Norvège]Source :
- Health and Quality of Life Outcomes [ 1477-7525 ] ; 2010.
Abstract
We previously reported that changes of 6-17 percent in the EORTC QLQ-C30 scores are regarded important by patients with multiple myeloma and thus may be considered as Minimal Important Differences (MIDs). However, patients' internal standard of measurement may have changed over time (response shift, RS). In the present work, we evaluated whether myeloma patients experience RS and if this could affect the MID-estimates.
Between 2006 and 2008, 239 patients with multiple myeloma completed the EORTC QLQ-C30 at baseline (T1) and after three months (T2). At T2, patients were asked if they had noticed any change in the domains pain, fatigue, physical function and global quality of life. They were also asked to give a retrospective judgment of their baseline values on all the four domains.
We found clear evidence of RS in myeloma patients. However, there were differences in both magnitude and direction between patients who stated that they improved and those who deteriorated. Deteriorating patients retrospectively reported better health-related quality of life at T1 for the domains pain, fatigue and physical function. In these patients, MIDs adjusted for RS were observed to increase up to 12 percentage points. In contrast, for patients stating that they improved, we only found evidence of statistically significant RS in the domain global quality of life.
MIDs estimated from pre-test/post-test data appeared to be robust against RS in patients reporting improvement over 3-months. This could indicate that RS has a minimal impact on the results in patients who respond to treatment, and that RS may not have an important impact on interpretation of changes reported in clinical trials where an improvement occurs.
Although the effect sizes of the RSs were small, RS in deteriorating patients may have an important impact on the interpretation of changes reported in clinical trials.
The study is registered at clinicaltrials.gov, identifier NCT00290095.
Url:
DOI: 10.1186/1477-7525-8-79
PubMed: 20678240
PubMed Central: 2922103
Affiliations:
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Kvam</name><affiliation wicri:level="1"><nlm:aff id="I1">Dept. of Haematology, Oslo University Hospital, Ullevaal, Norway</nlm:aff><country xml:lang="fr">Norvège</country><wicri:regionArea>Dept. of Haematology, Oslo University Hospital, Ullevaal</wicri:regionArea><wicri:noRegion>Ullevaal</wicri:noRegion></affiliation><affiliation wicri:level="3"><nlm:aff id="I2">Faculty of Medicine, University of Oslo, Oslo, Norway</nlm:aff><country xml:lang="fr">Norvège</country><wicri:regionArea>Faculty of Medicine, University of Oslo, Oslo</wicri:regionArea><placeName><settlement type="city">Oslo</settlement><region nuts="2">Østlandet</region></placeName></affiliation></author><author><name sortKey="Wisl Ff, Finn" sort="Wisl Ff, Finn" uniqKey="Wisl Ff F" first="Finn" last="Wisl Ff">Finn Wisl Ff</name><affiliation wicri:level="1"><nlm:aff id="I1">Dept. of Haematology, Oslo University Hospital, Ullevaal, Norway</nlm:aff><country xml:lang="fr">Norvège</country><wicri:regionArea>Dept. of Haematology, Oslo University Hospital, Ullevaal</wicri:regionArea><wicri:noRegion>Ullevaal</wicri:noRegion></affiliation><affiliation wicri:level="3"><nlm:aff id="I2">Faculty of Medicine, University of Oslo, Oslo, Norway</nlm:aff><country xml:lang="fr">Norvège</country><wicri:regionArea>Faculty of Medicine, University of Oslo, Oslo</wicri:regionArea><placeName><settlement type="city">Oslo</settlement><region nuts="2">Østlandet</region></placeName></affiliation></author><author><name sortKey="Fayers, Peter M" sort="Fayers, Peter M" uniqKey="Fayers P" first="Peter M" last="Fayers">Peter M. 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Kvam</name><affiliation wicri:level="1"><nlm:aff id="I1">Dept. of Haematology, Oslo University Hospital, Ullevaal, Norway</nlm:aff><country xml:lang="fr">Norvège</country><wicri:regionArea>Dept. of Haematology, Oslo University Hospital, Ullevaal</wicri:regionArea><wicri:noRegion>Ullevaal</wicri:noRegion></affiliation><affiliation wicri:level="3"><nlm:aff id="I2">Faculty of Medicine, University of Oslo, Oslo, Norway</nlm:aff><country xml:lang="fr">Norvège</country><wicri:regionArea>Faculty of Medicine, University of Oslo, Oslo</wicri:regionArea><placeName><settlement type="city">Oslo</settlement><region nuts="2">Østlandet</region></placeName></affiliation></author><author><name sortKey="Wisl Ff, Finn" sort="Wisl Ff, Finn" uniqKey="Wisl Ff F" first="Finn" last="Wisl Ff">Finn Wisl Ff</name><affiliation wicri:level="1"><nlm:aff id="I1">Dept. of Haematology, Oslo University Hospital, Ullevaal, Norway</nlm:aff><country xml:lang="fr">Norvège</country><wicri:regionArea>Dept. of Haematology, Oslo University Hospital, Ullevaal</wicri:regionArea><wicri:noRegion>Ullevaal</wicri:noRegion></affiliation><affiliation wicri:level="3"><nlm:aff id="I2">Faculty of Medicine, University of Oslo, Oslo, Norway</nlm:aff><country xml:lang="fr">Norvège</country><wicri:regionArea>Faculty of Medicine, University of Oslo, Oslo</wicri:regionArea><placeName><settlement type="city">Oslo</settlement><region nuts="2">Østlandet</region></placeName></affiliation></author><author><name sortKey="Fayers, Peter M" sort="Fayers, Peter M" uniqKey="Fayers P" first="Peter M" last="Fayers">Peter M. Fayers</name><affiliation wicri:level="2"><nlm:aff id="I3">Division of Applied Health Sciences, University of Aberdeen, Aberdeen, Scotland</nlm:aff><country>Royaume-Uni</country><placeName><region type="country">Écosse</region></placeName><wicri:cityArea>Division of Applied Health Sciences, University of Aberdeen, Aberdeen</wicri:cityArea></affiliation><affiliation wicri:level="3"><nlm:aff id="I4">Pain and Palliation Research Group, Dept. of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway</nlm:aff><country xml:lang="fr">Norvège</country><wicri:regionArea>Pain and Palliation Research Group, Dept. of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology (NTNU), Trondheim</wicri:regionArea><placeName><settlement type="city">Trondheim</settlement><region type="région" nuts="2">Trøndelag</region></placeName></affiliation></author></analytic><series><title level="j">Health and Quality of Life Outcomes</title><idno type="eISSN">1477-7525</idno><imprint><date when="2010">2010</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>We previously reported that changes of 6-17 percent in the EORTC QLQ-C30 scores are regarded important by patients with multiple myeloma and thus may be considered as Minimal Important Differences (MIDs). However, patients' internal standard of measurement may have changed over time (response shift, RS). In the present work, we evaluated whether myeloma patients experience RS and if this could affect the MID-estimates.</p></sec><sec><title>Methods</title><p>Between 2006 and 2008, 239 patients with multiple myeloma completed the EORTC QLQ-C30 at baseline (T1) and after three months (T2). At T2, patients were asked if they had noticed any change in the domains pain, fatigue, physical function and global quality of life. They were also asked to give a retrospective judgment of their baseline values on all the four domains.</p></sec><sec><title>Results</title><p>We found clear evidence of RS in myeloma patients. However, there were differences in both magnitude and direction between patients who stated that they improved and those who deteriorated. Deteriorating patients retrospectively reported better health-related quality of life at T1 for the domains pain, fatigue and physical function. In these patients, MIDs adjusted for RS were observed to increase up to 12 percentage points. In contrast, for patients stating that they improved, we only found evidence of statistically significant RS in the domain global quality of life.</p></sec><sec><title>Conclusions</title><p>MIDs estimated from pre-test/post-test data appeared to be robust against RS in patients reporting improvement over 3-months. This could indicate that RS has a minimal impact on the results in patients who respond to treatment, and that RS may not have an important impact on interpretation of changes reported in clinical trials where an improvement occurs.</p><p>Although the effect sizes of the RSs were small, RS in deteriorating patients may have an important impact on the interpretation of changes reported in clinical trials.</p></sec><sec><title>Trial registration</title><p>The study is registered at clinicaltrials.gov, identifier NCT00290095.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Howard, Gs" uniqKey="Howard G">GS Howard</name></author><author><name sortKey="Ralph, Km" uniqKey="Ralph K">KM Ralph</name></author><author><name sortKey="Gulanick, Na" uniqKey="Gulanick N">NA Gulanick</name></author><author><name sortKey="Maxwell, Se" uniqKey="Maxwell S">SE Maxwell</name></author><author><name sortKey="Nance, Dw" uniqKey="Nance D">DW 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Fj" uniqKey="Oort F">FJ Oort</name></author><author><name sortKey="Sprangers, Ma" uniqKey="Sprangers M">MA Sprangers</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Johnsen, At" uniqKey="Johnsen A">AT Johnsen</name></author><author><name sortKey="Tholstrup, D" uniqKey="Tholstrup D">D Tholstrup</name></author><author><name sortKey="Petersen, Ma" uniqKey="Petersen M">MA Petersen</name></author><author><name sortKey="Pedersen, L" uniqKey="Pedersen L">L Pedersen</name></author><author><name sortKey="Groenvold, M" uniqKey="Groenvold M">M Groenvold</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bottomley, A" uniqKey="Bottomley A">A Bottomley</name></author><author><name sortKey="Therasse, P" uniqKey="Therasse P">P Therasse</name></author><author><name sortKey="Piccart, M" uniqKey="Piccart M">M Piccart</name></author><author><name sortKey="Efficace, F" uniqKey="Efficace F">F Efficace</name></author><author><name sortKey="Coens, C" uniqKey="Coens C">C Coens</name></author><author><name sortKey="Gotay, C" uniqKey="Gotay C">C Gotay</name></author><author><name sortKey="Welnicka Jaskiewicz, M" uniqKey="Welnicka Jaskiewicz M">M Welnicka-Jaskiewicz</name></author><author><name sortKey="Mauriac, L" uniqKey="Mauriac L">L Mauriac</name></author><author><name sortKey="Dyczka, J" uniqKey="Dyczka J">J Dyczka</name></author><author><name sortKey="Cufer, T" uniqKey="Cufer T">T Cufer</name></author><author><name sortKey="Lichinitser, Mr" uniqKey="Lichinitser M">MR Lichinitser</name></author><author><name sortKey="Schornagel, Jh" uniqKey="Schornagel J">JH Schornagel</name></author><author><name sortKey="Bonnefoi, H" uniqKey="Bonnefoi H">H Bonnefoi</name></author><author><name sortKey="Shepherd, L" uniqKey="Shepherd L">L Shepherd</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Zenger, M" uniqKey="Zenger M">M Zenger</name></author><author><name sortKey="Hinz, A" uniqKey="Hinz A">A Hinz</name></author><author><name sortKey="Stolzenburg, Ju" uniqKey="Stolzenburg J">JU Stolzenburg</name></author><author><name sortKey="Rabenalt, R" uniqKey="Rabenalt R">R Rabenalt</name></author><author><name sortKey="Schwalenberg, T" uniqKey="Schwalenberg T">T Schwalenberg</name></author><author><name sortKey="Schwarz, R" uniqKey="Schwarz R">R Schwarz</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Turesson, I" uniqKey="Turesson I">I Turesson</name></author><author><name sortKey="Velez, R" uniqKey="Velez R">R Velez</name></author><author><name sortKey="Kristinsson, Sy" uniqKey="Kristinsson S">SY Kristinsson</name></author><author><name sortKey="Landgren, O" uniqKey="Landgren O">O Landgren</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Norvège</li><li>Royaume-Uni</li></country><region><li>Trøndelag</li><li>Écosse</li><li>Østlandet</li></region><settlement><li>Oslo</li><li>Trondheim</li></settlement></list><tree><country name="Norvège"><noRegion><name sortKey="Kvam, Ann K" sort="Kvam, Ann K" uniqKey="Kvam A" first="Ann K" last="Kvam">Ann K. Kvam</name></noRegion><name sortKey="Fayers, Peter M" sort="Fayers, Peter M" uniqKey="Fayers P" first="Peter M" last="Fayers">Peter M. Fayers</name><name sortKey="Kvam, Ann K" sort="Kvam, Ann K" uniqKey="Kvam A" first="Ann K" last="Kvam">Ann K. Kvam</name><name sortKey="Wisl Ff, Finn" sort="Wisl Ff, Finn" uniqKey="Wisl Ff F" first="Finn" last="Wisl Ff">Finn Wisl Ff</name><name sortKey="Wisl Ff, Finn" sort="Wisl Ff, Finn" uniqKey="Wisl Ff F" first="Finn" last="Wisl Ff">Finn Wisl Ff</name></country><country name="Royaume-Uni"><region name="Écosse"><name sortKey="Fayers, Peter M" sort="Fayers, Peter M" uniqKey="Fayers P" first="Peter M" last="Fayers">Peter M. Fayers</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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