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Patient-Reported Outcome Measures in Cardiovascular Disease: An Evidence Map of the Psychometric Properties of Health Status Instruments.

Publication ,  Journal Article
Chew, DS; Whitelaw, S; Vaduganathan, M; Mark, DB; Van Spall, HGC
Published in: Ann Intern Med
October 2022

BACKGROUND: Patient-reported outcomes (PROs) are important measures of treatment effect and can be used to inform the approval of cardiovascular drugs and devices by the U.S. Food and Drug Administration (FDA). PURPOSE: To catalogue the health status patient-reported outcome measures (PROMs) validated in cardiovascular diseases (CVDs), describe their psychometric properties, and assess adherence with both FDA recommendations and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) framework. DATA SOURCES: MEDLINE, EMBASE, CINAHL, and Allied and Complementary Medicine Database from inception to August 2022. STUDY SELECTION: Studies that developed and/or validated health status PROMs in CVD populations. DATA EXTRACTION: Two study authors extracted data on CVD type, PROM psychometric properties, and adherence to FDA recommendations. The risk of bias informing the development or validation of PROMs was assessed using the COSMIN framework. DATA SYNTHESIS: Fifty health status PROMs (described in 83 studies) were identified, of which 45 were disease specific and 5 were generic. Eleven (22%) of the 50 PROMs validated in CVDs had minimally important differences (MIDs) established, and 8 (16%) reported on the validation of all psychometric properties recommended by the FDA. By COSMIN standards, only 2 PROMs (4%) had all of their psychometric properties rated as sufficient in quality, and 32 PROMs (64%) had less than 50% of psychometric properties rated as sufficient. LIMITATION: The quality of reporting varied across included studies. CONCLUSION: Of 50 PROMs validated in CVDs, only a small minority reported on the validation of all FDA-recommended psychometric properties, had psychometric properties rated as sufficient by COSMIN, or had MIDs established. Given the use of PROMs to guide FDA approvals of drugs and devices in CVDs, there is a need for better adherence to quality standards in PROM validation. PRIMARY FUNDING SOURCE: None.

Duke Scholars

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Published In

Ann Intern Med

DOI

EISSN

1539-3704

Publication Date

October 2022

Volume

175

Issue

10

Start / End Page

1431 / 1439

Location

United States

Related Subject Headings

  • Surveys and Questionnaires
  • Quality of Life
  • Psychometrics
  • Patient Reported Outcome Measures
  • Humans
  • Health Status
  • General & Internal Medicine
  • Cardiovascular Diseases
  • Cardiovascular Agents
  • 3202 Clinical sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Chew, D. S., Whitelaw, S., Vaduganathan, M., Mark, D. B., & Van Spall, H. G. C. (2022). Patient-Reported Outcome Measures in Cardiovascular Disease: An Evidence Map of the Psychometric Properties of Health Status Instruments. Ann Intern Med, 175(10), 1431–1439. https://doi.org/10.7326/M22-2234
Chew, Derek S., Sera Whitelaw, Muthiah Vaduganathan, Daniel B. Mark, and Harriette G. C. Van Spall. “Patient-Reported Outcome Measures in Cardiovascular Disease: An Evidence Map of the Psychometric Properties of Health Status Instruments.Ann Intern Med 175, no. 10 (October 2022): 1431–39. https://doi.org/10.7326/M22-2234.
Chew DS, Whitelaw S, Vaduganathan M, Mark DB, Van Spall HGC. Patient-Reported Outcome Measures in Cardiovascular Disease: An Evidence Map of the Psychometric Properties of Health Status Instruments. Ann Intern Med. 2022 Oct;175(10):1431–9.
Chew, Derek S., et al. “Patient-Reported Outcome Measures in Cardiovascular Disease: An Evidence Map of the Psychometric Properties of Health Status Instruments.Ann Intern Med, vol. 175, no. 10, Oct. 2022, pp. 1431–39. Pubmed, doi:10.7326/M22-2234.
Chew DS, Whitelaw S, Vaduganathan M, Mark DB, Van Spall HGC. Patient-Reported Outcome Measures in Cardiovascular Disease: An Evidence Map of the Psychometric Properties of Health Status Instruments. Ann Intern Med. 2022 Oct;175(10):1431–1439.

Published In

Ann Intern Med

DOI

EISSN

1539-3704

Publication Date

October 2022

Volume

175

Issue

10

Start / End Page

1431 / 1439

Location

United States

Related Subject Headings

  • Surveys and Questionnaires
  • Quality of Life
  • Psychometrics
  • Patient Reported Outcome Measures
  • Humans
  • Health Status
  • General & Internal Medicine
  • Cardiovascular Diseases
  • Cardiovascular Agents
  • 3202 Clinical sciences