We have categorized notable and foundational publications to give more information that relates to our work, the work of our colleagues, and the PRO research community. This list will be updated on a regular basis, as more publications are available.
Patient-reported outcomes (PROs):
SPIRIT-PRO extension (PRO-specific protocol guidance):Calvert et al, 2018
SISAQOL recommendations (statistical standards for PRO data in randomized trials):
Coens et al, 2020
CONSORT-PRO extension:
Calvert et al, 2013
PRO-cision Medicine Toolkit (Medical Care edition focused on PROs implemented in clinical practice):
Snyder et al, 2019
Shi et al, 2016
Cook et al, 2019
Brown & Cano, 2019
Jensen & Bjorner, 2019
Oliver et al, 2019
King et al, 2019
Blackford et al, 2019
Haverman et al, 2019
Absolom et al, 2019
Zahrieh et al, 2019
Barbera & Moody, 2019
Girgis et al, 2019
Stover et al, 2019
PROMIS:
PROMIS scales to PRO-CTCAE and single-item numeric rating scale items:Lee et al, 2020
PROMIS reporting recommendations:
Hanmer et al, 2020
PRO-CTCAE:
Item generation:Basch et al, 2014
Cognitive testing:
Hay et al, 2013
Validity, reliability, & responsiveness:
Dueck et al, 2015
Comparison of modes of administration (paper, web, & automated telephone):
Bennett et al, 2016
Assessment of patient recall from 1 to 4 weeks:
Mendoza et al, 2017
Pediatric (and proxy) PRO-CTCAE:
Reeve et al, 2017
US FDA & NCI view on clinical review, IND safety reporting, & site inspections:
Kim et al, 2018
Strategy to select symptomatic AEs for administration:
Trask et al, 2018
What do “Mild”, “Moderate”, … mean to patients?:
Atkinson et al, 2018
Use of free text items:
Chung et al, 2019
Feasibility of PRO-CTCAE reporting:
Basch et al, 2017
Basch et al, 2018
Composite scoring algorithm:
Basch et al, 2021
Example of PRO-CTCAE in a trial (PRO-CTCAE is reported in the supplemental appendix):
Gounder et al, 2018
PRO-CTCAE baseline adjustment method:
Dueck et al, 2020
Adverse event (AE) analysis:
Lancet Haematology Commission on modernizing approach to AEs:Thanarajasingam et al, 2018
Update to Lancet Haematology Commission:
Thanarajasingam et al, 2022
Thanarajasingam ToxT references:
Thanarajasingam et al, 2016
Thanarajasingam et al, 2016
Thanarajasingam et al, 2020
Wong et al, 2021
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If you are looking for more information on any of the above articles, or think a publication should be added, feel free to reach out to our team! DueckLab@mayo.edu