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. 2022 Sep;22(9):405-421.
doi: 10.1007/s11892-022-01482-z. Epub 2022 Jul 11.

Content Validity of Patient-Reported Outcome Measures Developed for Assessing Health-Related Quality of Life in People with Type 2 Diabetes Mellitus: a Systematic Review

Caroline B Terwee  1 , Petra J M Elders  2 , Marlous Langendoen-Gort  2 , Ellen B M Elsman  3 , Cecilia A C Prinsen  3 , Amber A van der Heijden  2 , Maartje de Wit  4 , Joline W J Beulens  3 , Lidwine B Mokkink  3 , Femke Rutters  3
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Content Validity of Patient-Reported Outcome Measures Developed for Assessing Health-Related Quality of Life in People with Type 2 Diabetes Mellitus: a Systematic Review

Caroline B Terwee et al. Curr Diab Rep. 2022 Sep.

Abstract

Purpose of review: We aimed to systematically evaluate the content validity of patient-reported outcome measures (PROMs) specifically developed to measure (aspects of) health-related quality of life (HRQOL) in people with type 2 diabetes. A systematic review was performed in PubMed and Embase of PROMs measuring perceived symptoms, physical function, mental function, social function/participation, and general health perceptions, and that were validated to at least some extent. Content validity (relevance, comprehensiveness, and comprehensibility) was evaluated using COSMIN methodology.

Recent findings: We identified 54 (different versions of) PROMs, containing 150 subscales. We found evidence for sufficient content validity for only 41/150 (27%) (subscales of) PROMs. The quality of evidence was generally very low. We found 66 out of 150 (44%) (subscales of) PROMs with evidence for either insufficient relevance, insufficient comprehensiveness, or insufficient comprehensibility. For measuring diabetes-specific symptoms, physical function, mental function, social function/participation, and general health perceptions, we identified one to 11 (subscales of) PROMs with sufficient content validity, although quality of the evidence was generally low. For measuring depressive symptoms, no PROM with sufficient content validity was identified. For each aspect of HRQL, we found at least one PROM with sufficient content validity, except for depressive symptoms. The quality of the evidence was mostly very low.

Keywords: Diabetes; Patient-reported outcomes; Quality of life; Questionnaire; Systematic review; Validity.

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Conflict of interest statement

M de Wit was co-author on one of the included PROM development papers [71]. She was not involved in any of the ratings of this paper.

Figures

Fig. 1
Fig. 1
Model of health outcomes based on Wilson and Cleary [72]
Fig. 2
Fig. 2
Flow chart of the search strategy
See this image and copyright information in PMC

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