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Analyses of quality of life in cancer drug trials - a review of measurements and analytical choices in post-reimbursement studies.
Svensson, Mikael; Strand, Gabriella Chauca; Bonander, Carl; Johansson, Naimi; Jakobsson, Niklas.
Afiliación
  • Svensson M; Department of Pharmaceutical Outcomes & Policy, College of Pharmacy, University of Florida, 1225 Center Dr, Gainesville, FL, 32610, USA. svensson.kmikael@ufl.edu.
  • Strand GC; School of Public Health & Community Medicine, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden. svensson.kmikael@ufl.edu.
  • Bonander C; School of Public Health & Community Medicine, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden.
  • Johansson N; School of Public Health & Community Medicine, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden.
  • Jakobsson N; Centre for Societal Risk Research, Karlstad University, Karlstad, Sweden.
BMC Cancer ; 24(1): 311, 2024 Mar 06.
Article en En | MEDLINE | ID: mdl-38448848
ABSTRACT

OBJECTIVES:

For drugs reimbursed with limited evidence of patient benefits, confirmatory evidence of overall survival (OS) and quality of life (QoL) benefits is important. For QoL data to serve as valuable input to patients and decision-makers, it must be measured and analyzed using appropriate methods. We aimed to assess the measurement and analyses of post-reimbursement QoL data for cancer drugs introduced in Swedish healthcare with limited evidence at the time of reimbursement.

METHODS:

We reviewed any published post-reimbursement trial data on QoL for cancer drugs reimbursed in Sweden between 2010 and 2020 with limited evidence of improvement in QoL and OS benefits at the time of reimbursement. We extracted information on the instruments used, frequency of measurement, extent of missing data, statistical approaches, and the use of pre-registration and study protocols.

RESULTS:

Out of 22 drugs satisfying our inclusion criteria, we identified published QoL data for 12 drugs in 22 studies covering multiple cancer types. The most frequently used QoL instruments were EORTC QLQ-C30 and EQ-5D-3/5L. We identified three areas needing improvement in QoL measurement and

analysis:

(i) motivation for the frequency of measurements, (ii) handling of the substantial missing data problem, and (iii) inclusion and adherence to QoL analyses in clinical trial pre-registration and study protocols.

CONCLUSIONS:

Our review shows that the measurements and analysis of QoL data in our sample of cancer trials covering drugs initially reimbursed without any confirmed QoL or OS evidence have significant room for improvement. The increasing use of QoL assessments must be accompanied by a stricter adherence to best-practice guidelines to provide valuable input to patients and decision-makers.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Neoplasias Límite: Humans País/Región como asunto: Europa Idioma: En Revista: BMC Cancer Asunto de la revista: NEOPLASIAS Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Neoplasias Límite: Humans País/Región como asunto: Europa Idioma: En Revista: BMC Cancer Asunto de la revista: NEOPLASIAS Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido