BrundageMBassBDavidsonJ, et al. Patterns of reporting health-related quality of life outcomes in randomized clinical trials: implications for clinicians and quality of life researchers. Qual Life Res. 2011;20:653-664. doi:10.1007/s11136-010-9793-3
2.
BylickiOGanHKJolyFMailletDYouBPeronJ.Poor patient-reported outcomes reporting according to CONSORT guidelines in randomized clinical trials evaluating systemic cancer therapy. Ann Oncol. 2014;26(1):231-237.
3.
CalvertMBlazebyJAltmanDG, et al. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013;309:814-822. doi:10.1001/jama.2013.879
4.
CalvertMBrundageMJacobsenPBSchunemannHJEfficaceF.The CONSORT patient-reported outcome (PRO) extension: implications for clinical trials and practice. Health Qual Life Outcomes. 2013;11:184. doi:10.1186/1477-7525-11-184
5.
CalvertMKingMMercieca-BebberR, et al. SPIRIT PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials. BMJ Open. 2021;11:e045105. doi:10.1136/bmjopen-2020-045105
6.
CalvertMKyteDMercieca-BebberR, et al. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension. JAMA. 2018;319(5):483-494. doi:10.1001/jama.2017.21903
7.
EfficaceFFayersPPusicA, et al. Quality of patient-reported outcome reporting across cancer randomized controlled trials according to the CONSORT patient-reported outcome extension: a pooled analysis of 557 trials. Cancer. 2015;121(18):3335-3342.
HanmerJJensenRERothrockN; HealthMeasures Team. A reporting checklist for HealthMeasures’ patient-reported outcomes: ASCQ-Me, Neuro-QoL, NIH Toolbox, and PROMIS. J Patient Rep Outcomes. 2020;4:21. doi:10.1186/s41687-020-0176-4
10.
HostnikJSStrongBReevesMJ.Utilization and reporting of patient-reported outcome measures in randomized clinical trials of acute stroke (2010-2020). Stroke. 2024;55(5):1174-1180. doi:10.1161/STROKEAHA.123.046209
11.
JolyFVardyJPintilieMTannockIF.Quality of life and/or symptom control in randomized clinical trials for patients with advanced cancer. Ann Oncol. 2007;18(12):1935-1942.
12.
KyteDRetzerAAhmedK, et al. Systematic evaluation of patient-reported outcome protocol content and reporting in cancer trials. J Natl Cancer Inst. 2019;111(11):1170-1178.
13.
Mercieca-BebberRAiyegbusiOLKingMTBrundageMSnyderCCalvertM.Knowledge translation concerns for the CONSORT-PRO extension reporting guidance: a review of reviews. Qual Lif Res. 2022;31:2939-2957. doi:10.1007/s11136-022-03119-w
14.
Mercieca-BebberRRouetteJCalvertM, et al. Preliminary evidence on the uptake, use and benefits of the CONSORT-PRO extension. Qual Life Res. 2017;26(6):1427-1437.
15.
PrinsenCACMokkinkLBBouterLM, et al. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res. 2018;27(5):1147-1157.
16.
US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER).Patient-focused drug development: methods to identify what is important to patients. Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders. 2022. Accessed May 29, 2025. https://www.fda.gov/media/131230/download