S'abonner

Recommendations on the use of item libraries for patient-reported outcome measurement in oncology trials: findings from an international, multidisciplinary working group - 31/01/23

Doi : 10.1016/S1470-2045(22)00654-4 
Claire Piccinin, MSc a, , Ethan Basch, MD b, Vishal Bhatnagar, MD c, Melanie Calvert, ProfPhD d, e, f, g, h, Alicyn Campbell, MPh i, David Cella, ProfPhD j, Charles S Cleeland, ProfPhD k, Corneel Coens, MSc a, Anne-Sophie Darlington, ProfPhD l, Amylou C Dueck, PhD m, Mogens Groenvold, ProfMD n, o, Ralf Herold, MD p, Bellinda L King-Kallimanis, PhD q, Paul G Kluetz, MD c, Dagmara Kuliś, MA a, Daniel O’Connor, MBChB r, Kathy Oliver, BA s, Madeline Pe, PhD a, Bryce B Reeve, ProfPhD t, Jaap C Reijneveld, MD u, Xin Shelley Wang, ProfMD k, Andrew Bottomley, PhD a
a Quality of Life Department, European Organisation for Research and Treatment of Cancer, Brussels, Belgium 
b Department of Medicine, University of North Carolina, Chapel Hill, NC, USA 
c Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA 
d Centre for Patient-Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK 
e Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK 
f National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, University of Birmingham, Birmingham, UK 
g NIHR Surgical Reconstruction and Microbiology Research Centre, University of Birmingham, Birmingham, UK 
h NIHR Applied Research Collaboration West Midlands, Birmingham, UK 
i Digital Health Oncology R&D, AstraZeneca, Gaithersburg, MD, USA 
j Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Evanston, IL, USA 
k Department of Symptom Research, MD Anderson Cancer Center, University of Texas, Houston, TX, USA 
l School of Health Sciences, University of Southampton, Southampton, UK 
m Department of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ, USA 
n Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark 
o University of Copenhagen, Copenhagen, Denmark 
p European Medicines Agency, Amsterdam, Netherlands 
q LUNGevity Foundation, Chicago, IL, USA 
r Medicines and Healthcare products Regulatory Agency, London, UK 
s International Brain Tumour Alliance, Tadworth, UK 
t Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA 
u Brain Tumor Center Amsterdam, Amsterdam University Medical Center, Amsterdam, Netherlands 

* Correspondence to: Ms Claire Piccinin, Quality of Life Department, European Organisation for Research and Treatment of Cancer, Brussels 1200, Belgium Quality of Life Department European Organisation for Research and Treatment of Cancer Brussels 1200 Belgium

Summary

The use of item libraries for patient-reported outcome (PRO) measurement in oncology allows for the customisation of PRO assessment to measure key health-related quality of life concepts of relevance to the target population and intervention. However, no high-level recommendations exist to guide users on the design and implementation of these customised PRO measures (item lists) across different PRO measurement systems. To address this issue, a working group was set up, including international stakeholders (academic, independent, industry, health technology assessment, regulatory, and patient advocacy), with the goal of creating recommendations for the use of item libraries in oncology trials. A scoping review was carried out to identify relevant publications and highlight any gaps. Stakeholders commented on the available guidance for each research question, proposed recommendations on how to address gaps in the literature, and came to an agreement using discussion-based methods. Nine primary research questions were identified that formed the scope and structure of the recommendations on how to select items and implement item lists created from item libraries. These recommendations address methods to drive item selection, plan the structure and analysis of item lists, and facilitate their use in conjunction with other measures. The findings resulted in high-level, instrument-agnostic recommendations on the use of item-library-derived item lists in oncology trials.

Le texte complet de cet article est disponible en PDF.

Plan


© 2023  Elsevier Ltd. Tous droits réservés.
Ajouter à ma bibliothèque Retirer de ma bibliothèque Imprimer
Export

    Export citations

  • Fichier

  • Contenu

Vol 24 - N° 2

P. e86-e95 - février 2023 Retour au numéro
Article précédent Article précédent
  • Defining genomic, transcriptomic, proteomic, epigenetic, and phenotypic biomarkers with prognostic capability in male breast cancer: a systematic review
  • Subarnarekha Chatterji, Emma Krzoska, Christopher W Thoroughgood, John Saganty, Peng Liu, Beatrix Elsberger, Rasha Abu-Eid, Valerie Speirs
| Article suivant Article suivant
  • Pharmaceutical industry relationships with oncologists in sub-Saharan Africa
  • Fidel Rubagumya, Miriam Mutebi, Achille Manirakiza, Omar Abdihamid, Melinda Mushonga, Verna Vanderpuye, Nazik Hammad, Christopher M Booth

Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.

Déjà abonné à cette revue ?

Mon compte


Plateformes Elsevier Masson

Déclaration CNIL

EM-CONSULTE.COM est déclaré à la CNIL, déclaration n° 1286925.

En application de la loi nº78-17 du 6 janvier 1978 relative à l'informatique, aux fichiers et aux libertés, vous disposez des droits d'opposition (art.26 de la loi), d'accès (art.34 à 38 de la loi), et de rectification (art.36 de la loi) des données vous concernant. Ainsi, vous pouvez exiger que soient rectifiées, complétées, clarifiées, mises à jour ou effacées les informations vous concernant qui sont inexactes, incomplètes, équivoques, périmées ou dont la collecte ou l'utilisation ou la conservation est interdite.
Les informations personnelles concernant les visiteurs de notre site, y compris leur identité, sont confidentielles.
Le responsable du site s'engage sur l'honneur à respecter les conditions légales de confidentialité applicables en France et à ne pas divulguer ces informations à des tiers.


Tout le contenu de ce site: Copyright © 2024 Elsevier, ses concédants de licence et ses contributeurs. Tout les droits sont réservés, y compris ceux relatifs à l'exploration de textes et de données, a la formation en IA et aux technologies similaires. Pour tout contenu en libre accès, les conditions de licence Creative Commons s'appliquent.