Validity of instruments to measure physical activity may be questionable due to a lack of conceptual frameworks: a syste
- PDF / 334,258 Bytes
- 13 Pages / 595.28 x 793.7 pts Page_size
- 9 Downloads / 126 Views
REVIEW
Open Access
Validity of instruments to measure physical activity may be questionable due to a lack of conceptual frameworks: a systematic review Elena Gimeno-Santos1,2,3, Anja Frei4,5, Fabienne Dobbels6, Katja Rüdell7, Milo A Puhan4,8 and Judith Garcia-Aymerich1,2,3,9*, for the PROactive consortium
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. Keywords: Chronic heart disease, chronic respiratory disease, conceptual framework, elderly, patient reported outcomes, physical activity, questionnaire, systematic review
Background Patient-reported outcome (PRO) instruments have always been an important tool in epidemiological and clinical research. Recently, interest in these instruments has increased with their use as outcome measures in randomized trials of pharmacological and non-pharmacological interventions. Regulatory agencies, namely the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have developed guidance documents concerning the appropriate development, validation, and use of PRO instruments in clinical * Correspondence: [email protected] 1 Centre for Research in Environmental Epidemiology (CREAL), Barcelona, Spain Full list of author information is available at the end of the article
trials [1,2]. Particular emphasis has been placed on their validity, that is, the ability of a PRO to measure the concept that it is intended to measure. To this end, the use of conceptual frameworks is advised [3-6]. The conceptual framework explicitly defines the concepts measured by the instrument in a diagram that represents the relationships between the main concept (e.g., health-related quality o
Data Loading...
