Real-World Evidence: Patient-Reported Outcomes (PROs)
Section 10
Additional Resources
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:
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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.
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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). |
SECTIONS
sections
- Introduction
- How Are PRO Measures Used?
- Best Practices for Collecting PRO measures in Pragmatic Clinical Trials
- NIH HEAL, FDA, and Other Core Outcome Sets
- Choosing PRO Measures
- Cultural Adaptation and Linguistic Translation
- Case Study From Guiding Good Choices for Health
- Incorporating PRO Data Into the EHR
- Patient-Focused Drug Development
- Additional Resources
REFERENCES
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.
current section : Additional Resources
- Introduction
- How Are PRO Measures Used?
- Best Practices for Collecting PRO measures in Pragmatic Clinical Trials
- NIH HEAL, FDA, and Other Core Outcome Sets
- Choosing PRO Measures
- Cultural Adaptation and Linguistic Translation
- Case Study From Guiding Good Choices for Health
- Incorporating PRO Data Into the EHR
- Patient-Focused Drug Development
- Additional Resources