Literature DB >> 34277020

Systematic review on the use of patient-reported outcome measures in brain tumor studies: part of the Response Assessment in Neuro-Oncology Patient-Reported Outcome (RANO-PRO) initiative.

Linda Dirven1,2, Maartje E Vos1, Tobias Walbert3, Terri S Armstrong4, David Arons5, Martin J van den Bent6, Jaishri Blakeley7, Paul D Brown8, Helen Bulbeck9, Susan M Chang10, Corneel Coens11, Mark R Gilbert4, Robin Grant12, Rakesh Jalali13, Danielle Leach5, Heather Leeper4, Tito Mendoza14, Lakshmi Nayak15, Kathy Oliver16, Jaap C Reijneveld17,18, Emilie Le Rhun19, Larry Rubinstein20, Michael Weller21, Patrick Y Wen15, Martin J B Taphoorn1,2.   

Abstract

BACKGROUND: The Response Assessment in Neuro-Oncology Patient-Reported Outcome (RANO-PRO) working group aims to provide guidance on the use of PROs in brain tumor patients. PRO measures should be of high quality, both in terms of relevance and other measurement properties. This systematic review aimed to identify PRO measures that have been used in brain tumor studies to date.
METHODS: A systematic literature search for articles published up to June 25, 2020 was conducted in several electronic databases. Pre-specified inclusion criteria were used to identify studies using PRO measures assessing symptoms, (instrumental) activities of daily living [(I)ADL] or health-related quality of life (HRQoL) in adult patients with glioma, meningioma, primary central nervous system lymphoma, or brain metastasis.
RESULTS: A total of 215 different PRO measures were identified in 571 published and 194 unpublished studies. The identified PRO measures include brain tumor-specific, cancer-specific, and generic instruments, as well as instruments designed for other indications or multi- or single-item study-specific questionnaires. The most frequently used instruments were the EORTC QLQ-C30 and QLQ-BN20 (n = 286 and n = 247), and the FACT-Br (n = 167), however, the majority of the instruments were used only once or twice (150/215).
CONCLUSION: Many different PRO measures assessing symptoms, (I)ADL or HRQoL have been used in brain tumor studies to date. Future research should clarify whether these instruments or their scales/items exhibit good content validity and other measurement properties for use in brain tumor patients.
© The Author(s) 2021. Published by Oxford University Press on behalf of the Society for Neuro-Oncology and the European Association of Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Entities:  

Keywords:  activities of daily living; brain tumor; health-related quality of life; patient-reported outcome; symptoms

Year:  2021        PMID: 34277020      PMCID: PMC8278354          DOI: 10.1093/nop/npab013

Source DB:  PubMed          Journal:  Neurooncol Pract        ISSN: 2054-2577


  10 in total

1.  Health-related quality of life and other clinical outcome assessments in brain tumor patients: challenges in the design, conduct and interpretation of clinical trials.

Authors:  Linda Dirven; Terri S Armstrong; Martin J B Taphoorn
Journal:  Neurooncol Pract       Date:  2015-03

2.  Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms.

Authors:  Paul G Kluetz; Ashley Slagle; Elektra J Papadopoulos; Laura Lee Johnson; Martha Donoghue; Virginia E Kwitkowski; Wen-Hung Chen; Rajeshwari Sridhara; Ann T Farrell; Patricia Keegan; Geoffrey Kim; Richard Pazdur
Journal:  Clin Cancer Res       Date:  2016-01-12       Impact factor: 12.531

Review 3.  Glioma patient-reported outcome assessment in clinical care and research: a Response Assessment in Neuro-Oncology collaborative report.

Authors:  Terri S Armstrong; Linda Dirven; David Arons; Amanda Bates; Susan M Chang; Corneel Coens; Claire Espinasse; Mark R Gilbert; David Jenkinson; Paul Kluetz; Tito Mendoza; Larry Rubinstein; Joohee Sul; Michael Weller; Patrick Y Wen; Martin J van den Bent; Martin J B Taphoorn
Journal:  Lancet Oncol       Date:  2020-02       Impact factor: 41.316

4.  Patient-reported outcomes: an essential component of oncology drug development and regulatory review.

Authors:  Ethan Basch
Journal:  Lancet Oncol       Date:  2018-05       Impact factor: 41.316

5.  Clinical outcome assessments in neuro-oncology: a regulatory perspective.

Authors:  Joohee Sul; Paul G Kluetz; Elektra J Papadopoulos; Patricia Keegan
Journal:  Neurooncol Pract       Date:  2015-12-27

Review 6.  Report of the Jumpstarting Brain Tumor Drug Development Coalition and FDA clinical trials clinical outcome assessment endpoints workshop (October 15, 2014, Bethesda MD).

Authors:  Jennifer L Helfer; Patrick Y Wen; Jaishri Blakeley; Mark R Gilbert; Terri S Armstrong
Journal:  Neuro Oncol       Date:  2016-03       Impact factor: 12.300

Review 7.  Working plan for the use of patient-reported outcome measures in adults with brain tumours: a Response Assessment in Neuro-Oncology (RANO) initiative.

Authors:  Linda Dirven; Terri S Armstrong; Jaishri O Blakeley; Paul D Brown; Robin Grant; Rakesh Jalali; Heather Leeper; Tito Mendoza; Lakshmi Nayak; Jaap C Reijneveld; Emilie Le Rhun; Tobias Walbert; Michael Weller; Patrick Y Wen; Martin J B Taphoorn
Journal:  Lancet Oncol       Date:  2018-03       Impact factor: 41.316

Review 8.  Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada.

Authors:  Paul G Kluetz; Daniel J O'Connor; Katherine Soltys
Journal:  Lancet Oncol       Date:  2018-05       Impact factor: 41.316

Review 9.  Health-related quality of life of cranial WHO grade I meningioma patients: are current questionnaires relevant?

Authors:  Amir H Zamanipoor Najafabadi; Marthe C M Peeters; Daniel J Lobatto; Marieke L D Broekman; Timothy R Smith; Nienke R Biermasz; Saskia M Peerdeman; Wilco C Peul; Martin J B Taphoorn; Wouter R van Furth; Linda Dirven
Journal:  Acta Neurochir (Wien)       Date:  2017-09-27       Impact factor: 2.216

10.  Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.

Authors:  David Moher; Alessandro Liberati; Jennifer Tetzlaff; Douglas G Altman
Journal:  PLoS Med       Date:  2009-07-21       Impact factor: 11.069

  10 in total
  3 in total

1.  Palliative care implementation in neuro-oncology-Where do we come from, where do we go?

Authors:  Caroline Hertler
Journal:  Neurooncol Pract       Date:  2022-05-14

2.  Importance of evaluating health-related quality of life issues in survivors of WHO grade II or III gliomas.

Authors:  Linda Dirven
Journal:  Neurooncol Pract       Date:  2022-01-25

3.  Development of a core outcome set and identification of patient-reportable outcomes for primary brain tumour trials: protocol for the COBra study.

Authors:  Ameeta Retzer; Stephanie Sivell; Hannah Scott; Annmarie Nelson; Helen Bulbeck; Kathy Seddon; Robin Grant; Richard Adams; Colin Watts; Olalekan Lee Aiyegbusi; Pamela Kearns; Samantha Cruz Rivera; Linda Dirven; Elin Baddeley; Melanie Calvert; Anthony Byrne
Journal:  BMJ Open       Date:  2022-09-30       Impact factor: 3.006

  3 in total

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