Impact of open-label versus blinded study design on patient-reported outcomes data in randomized clinical trials of immunotherapy in advanced or metastatic cancer patients: a systematic review.
Bias
Immuno-oncology
Open label
Patient-reported outcomes
Quality of life
Randomized controlled trials
Journal
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation
ISSN: 1573-2649
Titre abrégé: Qual Life Res
Pays: Netherlands
ID NLM: 9210257
Informations de publication
Date de publication:
Mar 2022
Mar 2022
Historique:
accepted:
07
07
2021
pubmed:
21
7
2021
medline:
17
3
2022
entrez:
20
7
2021
Statut:
ppublish
Résumé
A systematic literature review of immuno-oncology trials was conducted to assess the potential impact of open-label vs double-blind trial design on patient-reported outcome (PRO) data. A systematic search of indexed literature published from January 2009 to May 2019 was conducted using PubMed/MEDLINE, Cochrane Library, and EMBASE database. All randomized clinical trials (RCTs) of immuno-oncology therapies on advanced cancer patients reporting PRO data were identified. Descriptive analyses were performed to quantify differences at baseline and over time, by the type of study, regarding questionnaire completion rate and PRO scores. In total, 23 studies were retained (15 open-label, 8 blinded). At baseline, no difference in completion rate was observed between arms irrespective of trial design (absolute mean difference of 2.8% and 2.2% for open label and blinded studies, respectively). No clinically significant difference in baseline PRO scores was observed between arms. Over time, impact on PRO scores could not be identified due to the limited number of studies, heterogeneity of questionnaires and tumor types. Trial design had no impact on PRO completion rate or baseline scores. Future research should involve analyses by specific cancer types and ideally compare individual data from two similar RCTs (blinded vs. open-label).
Identifiants
pubmed: 34283382
doi: 10.1007/s11136-021-02945-8
pii: 10.1007/s11136-021-02945-8
doi:
Types de publication
Journal Article
Review
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
645-657Informations de copyright
© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
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