Additional Resources

CHAPTER SECTIONS

Real-World Evidence: Patient-Reported Outcomes (PROs)


Section 10

Additional Resources

Contributors
Patient-Centered Outcomes Core Toolkit

The purpose of this toolkit is to provide resources to support the capture of patient-reported outcome measures in diverse study populations participating in the NIH Pragmatic Trials Collaboratory Trials and other pragmatic clinical trials. This toolkit contains a Checklist focused on health equity considerations and PROs, along with Additional Resources.
A CONSORT (Consolidated Standards of Reporting Trials) Statement extension regarding PROs Consort statement recommends 5 checklist items for randomized controlled trials in which PROs are primary or secondary endpoints:

  1. Identify PROs as primary or secondary outcomes in the abstract.
  2. Describe the hypothesis of the PROs and relevant domains (ie, if a multidimensional PRO tool has been used).
  3. Provide or cite evidence of the PRO instrument’s validity and reliability.
  4. Explicitly state statistical approaches for dealing with missing data.
  5. Discuss PRO-specific limitations of study findings and generalizability of results to other populations and clinical practice.
National Institutes of Health (NIH)-sponsored PRO Measurement Information Systems (PROMIS) PROMIS provides approximately 1900 adult and 600 pediatric measures for health-related PRO domains in a variety of conditions. The measures have been standardized to provide common domains and metrics across a wide range of conditions and diseases.

 
NIH Toolbox for the Assessment of Neurological and Behavioral Function The NIH Toolbox is a multidimensional set of brief measures assessing cognitive, emotional, motor, and sensory function in patients ranging from 3 to 85 years of age. The Toolbox is intended to provide consistent measurement across studies and a scientific basis for identifying evidence-based best practices (Gershon et al. 2013).
Neuro-QOL Neuro-QoL (Quality of Life in Neurological Disorders) is a set of PRO measures that assesses the HRQOL of adults and children with neurological disorders such as stroke, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson disease, epilepsy, and muscular dystrophy.
The Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) ASCQ-Me is a HRQOL instrument for adults with sickle cell disease that was designed to add specificity to the PROMIS HRQOL instrument in adults with sickle cell disease (Panepinto 2012).

Previous Section


SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction
  2. How Are PRO Measures Used?
  3. Best Practices for Collecting PRO Measures in Pragmatic Clinical Trials
  4. NIH HEAL, FDA, and Other Core Outcome Sets
  5. Choosing PRO Measures
  6. Cultural Adaptation and Linguistic Translation
  7. Case Study From Guiding Good Choices for Health
  8. Incorporating PRO Data Into the EHR
  9. Patient-Focused Drug Development
  10. Additional Resources

REFERENCES

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Gershon RC, Wagster MV, Hendrie HC, Fox NA, Cook KF, Nowinski CJ. 2013. NIH toolbox for assessment of neurological and behavioral function. Neurology. 80(11 Suppl 3):S2-6. doi:10.1212/WNL.0b013e3182872e5f. PMID: 23479538.

 

Panepinto JA. 2012. Health-related quality of life in patients with hemoglobinopathies. Hematology Am Soc Hematol Educ Program. 2012:284-289. doi:10.1182/asheducation-2012.1.284. PMID: 23233593.


Version History

Published May 30, 2020

current section :

Additional Resources

  1. Introduction
  2. How Are PRO Measures Used?
  3. Best Practices for Collecting PRO Measures in Pragmatic Clinical Trials
  4. NIH HEAL, FDA, and Other Core Outcome Sets
  5. Choosing PRO Measures
  6. Cultural Adaptation and Linguistic Translation
  7. Case Study From Guiding Good Choices for Health
  8. Incorporating PRO Data Into the EHR
  9. Patient-Focused Drug Development
  10. Additional Resources

Citation:

Zigler C, DeBar L, Weinfurt K. Real-World Evidence: Patient-Reported Outcomes (PROs): Additional Resources. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/conduct/real-world-evidence-patient-reported-outcomes-pros/additional-resources/. Updated March 6, 2026. DOI: 10.28929/142.