Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2011 Oct 3:9:86.
doi: 10.1186/1477-7525-9-86.

Validity of instruments to measure physical activity may be questionable due to a lack of conceptual frameworks: a systematic review

Collaborators, Affiliations

Validity of instruments to measure physical activity may be questionable due to a lack of conceptual frameworks: a systematic review

Elena Gimeno-Santos et al. Health Qual Life Outcomes. .

Abstract

Background: Guidance documents for the development and validation of patient-reported outcomes (PROs) advise the use of conceptual frameworks, which outline the structure of the concept that a PRO aims to measure. It is unknown whether currently available PROs are based on conceptual frameworks. This study, which was limited to a specific case, had the following aims: (i) to identify conceptual frameworks of physical activity in chronic respiratory patients or similar populations (chronic heart disease patients or the elderly) and (ii) to assess whether the development and validation of PROs to measure physical activity in these populations were based on a conceptual framework of physical activity.

Methods: Two systematic reviews were conducted through searches of the Medline, Embase, PsycINFO, and Cinahl databases prior to January 2010.

Results: In the first review, only 2 out of 581 references pertaining to physical activity in the defined populations provided a conceptual framework of physical activity in COPD patients. In the second review, out of 103 studies developing PROs to measure physical activity or related constructs, none were based on a conceptual framework of physical activity.

Conclusions: These findings raise concerns about how the large body of evidence from studies that use physical activity PRO instruments should be evaluated by health care providers, guideline developers, and regulatory agencies.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Flow diagram of process of systematic literature search.
Figure 2
Figure 2
Conceptual framework proposed by Leidy (COPD, 2007).
Figure 3
Figure 3
Conceptual framework proposed by Larson (COPD, 2007).

References

    1. Bottomley A, Jones D, Claassens L. Patient-reported outcomes: assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency. Eur J Cancer. 2009;45:347–353. doi: 10.1016/j.ejca.2008.09.032. - DOI - PubMed
    1. Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Reserach (CBER), Center for Devices and Radiological Health (CDRH) Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. 2009. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati... - PubMed
    1. American Psychological Association, American Educational Research Association, National Council on Measurement in Education. Standards for educational and psychological testing. Whashington, DC: American Psychological Association; 1985.
    1. Lohr KN, Aaronson NK, Alonso J, Burnam MA, Patrick DL, Perrin EB, Roberts JS. Evaluating quality-of-life and health status instruments: development of scientific review criteria. Clin Ther. 1996;18:979–992. doi: 10.1016/S0149-2918(96)80054-3. - DOI - PubMed
    1. Lohr KN. Assessing health status and quality-of-life instruments: Attributes and review criteria. Quality of Life Research. 2002;11:193–205. doi: 10.1023/A:1015291021312. - DOI - PubMed

Publication types

MeSH terms