Measurement References

The following references and resources may be useful in the design and conduct of research studies that include patient-reported outcome (PRO) measures or caregiver assessments

The following references and resources may be useful in the design and conduct of research studies that include patient-reported outcome (PRO) measures or caregiver assessments:

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Information about PROs to include in Clinical Trials

Calvert M, Kyte D, Mercieca-Bebber R, 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

Selecting PROs for Research Studies
Reeve BB, Wyrwich KW, Wu AW, et al. on behalf of the International Society for Quality of Life Research (ISOQOL). ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Quality of Life Research. 2013 Oct; 22(8):1889-905. doi: 10.1007/s11136-012-0344-y PMID: 23288613
NIH Assessment Tools
NIH Toolbox for Neurologic and Behavioral Research: http://www.nihtoolbox.org/Pages/default.aspx
NIH Patient-Reported Outcomes Measurement Information System (PROMIS): http://www.nihpromis.org/
NCI Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE): http://healthcaredelivery.cancer.gov/pro-ctcae/
Topic-Specific Instrument Reviews
Systematic Reviews of Instruments Relevant to Palliative Care, compiled by the PCRC   
AHRQ Evidence Review: Assessment Tools for Palliative Care
Systems for Web and Telephone-based PRO Survey Administration
Patient-Reported Outcomes Core (PRO-Core). University of North Carolina.  
PRO Data Analysis
Fairclough DL. Design and Analysis of Quality of Life Studies in Clinical Trials, 2nd edition. New York: Chapman & Hall/CRC Interdisciplinary Statistics Series, 2010.
Cappelleri JC, Zou KH, Bushmakin AG, et al. Patient-reported outcomes: measurement, implementation and interpretation. New York: Chapman & Hall/CRC Biostatistics Series, 2014.
Reporting PRO Results
Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013; 309(8):814-822 doi: 10.1001/jama.2013.879 PMID: 23443445
PRO Methodology – Scale Development, Translation and Cultural Adaptation
Patrick, D. L., et al. Content Validity-Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 1-Eliciting Concepts for a New PRO Instrument. Value Health. 2011; 14(8): 967-977. doi: 10.1016/j.jval.2011.06.014. PMID: 22152165
Patrick, D. L., et al. (2011). Content Validity-Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 2-Assessing Respondent Understanding. Value Health. 2011; 14(8): 978-988. doi: 10.1016/j.jval.2011.06.013. PMID: 22152166
Eremenco SL, Cella D, Arnold BJ. A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Evaluation & the Health Professions. 2005; 28(2):212-232. PMID: 15851774

 

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