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. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res. 2013;22(8):1889-1905. doi:10.1007/s11136-012-0344-y
NIH Assessment Tools
NIH Toolbox for Neurologic and Behavioral Research
NIH Patient-Reported Outcomes Measurement Information System (PROMIS)
NCI Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Topic-Specific Instrument Review
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 - Textbooks*
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.
*Both of these resources are textbooks. If you are interested in obtaining a copy of these, please search the titles provided above.
Reporting PRO Results
Calvert M, Blazeby J, Altman DG, et al. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013;309(8):814-822. doi:10.1001/jama.2013.879
PRO Methodology – Scale Development, Translation and Cultural Adaptation
Patrick DL, Burke LB, Gwaltney CJ, 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
Patrick DL, Burke LB, Gwaltney CJ, 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 2--assessing respondent understanding. Value Health. 2011;14(8):978-988. doi:10.1016/j.jval.2011.06.013
Eremenco SL, Cella D, Arnold BJ. A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Eval Health Prof. 2005;28(2):212-232. doi:10.1177/0163278705275342