Patient-reported outcome measures for assessing health-related quality of life in people with type 2 diabetes: A systematic review

Abstract

Patient-Reported Outcome Measures (PROMs) are important tools to assess outcomes relevant to patients, with Health-Related Quality Of Life (HRQOL) as an important construct to be measured. Many different HRQOL PROMs are used in the type 2 diabetes field, however a complete overview of these PROMs is currently lacking. We therefore aimed to systematically describe and classify the content of all PROMs that have specifically been developed or validated to measure (aspects of) HRQOL in people with type 2 diabetes. A literature search was performed in PubMed and EMBASE until 31 December 2021. Studies on the development or validation of a PROM measuring HRQOL, or aspects of HRQOL, in people with type 2 diabetes were included. Title and abstract and full-text screening were conducted by two independent researchers and data extraction was performed independently by one of the researchers. Data were extracted on language in which the PROM was developed, target population, construct(s) being measured, names of (sub)scales and number of items per (sub)scale. In addition, all PROMs and subscales were classified according to specific aspects of HRQOL based on the Wilson & Cleary model (symptom status, functional status, general health perceptions) to aid researchers in PROM selection. In total 220 studies were identified that developed or validated PROMs that measure (aspects of) HRQOL in people with type 2 diabetes. Of the 116 unique HRQOL PROMs, 91 (of the subscales) measured symptom status, 60 measured functional status and 26 measured general health perceptions. In addition, 16 of the PROMs (subscales) measured global quality of life. 61 of the 116 PROMs (subscales) also include characteristics of the individual (e.g. aspects of personality, coping) or environment (e.g. social or financial support) and patient-reported experience measures (PREMs, e.g. measure of a patient's perception of their personal experience of the healthcare they have received, e.g. treatment satisfaction), which are not part of the HRQOL construct. Only 9 of the 116 PROMs measure all aspects of HRQOL based on the Wilson & Cleary model. Finally, 8 of the 116 PROMs stating to measure HRQOL, measured no HRQOL construct. In conclusion, a large number of PROMs are available for people with type 2 diabetes, which intend to measure (aspects of) HRQOL. These PROMs measure a large variety of (sub)constructs, which are not all HRQOL constructs, with a small amount of PROMs not measuring HRQOL at all. There is a need for consensus on which aspects of HRQOL should be measured in people with type 2 diabetes and which PROMs to use in research and daily practice. PROSPERO: CRD42017071012. COMET database: http://www.comet-initiative.org/studies/details/956.

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

“…Another striking finding of this review is that many PROMs that claim to measure (aspects of) HRQOL measure in fact (partly) other things, such as contextual factors or patient experiences (Appendix 3). Examples of contextual factors are behaviour (diet adherence, self-management), attitudes, stigma, support, or financial worries [2]. These are important factors that influence HRQOL, but they are not aspects of HRQOL.…”

“…We performed a systematic review using the Consensusbased Standards for the Selection of Health Measurement Instruments (COSMIN) methodology for systematic reviews of PROMs [25] and for assessing content validity [6]. This review was part of a larger project that aimed to identify all PROMs measuring (aspects of) HRQOL used in the field of type 2 diabetes [2]. The protocol was registered in the PROSPERO database: CRD42017071012.…”

“…The full literature search and data extraction process are described elsewhere [2]. The exact search strategy can be found in Appendix 2.…”

“…Data extraction on PROM characteristics was performed in the larger review [2]. For this content validity review, characteristics of the study populations included in the PROM development and content validity studies, i.e.…”

“…Many different PROMs are used in care and research in people with type 2 diabetes, yet no consensus exists regarding which PROMs to use in research or clinical practice. In our recent systematic review, we identified 108 unique PROMs for measuring HRQOL in people with type 2 diabetes, addressing a variety of constructs [2]. The harmonization of PROMs for use in diabetes care and research has been challenged by a lack of conceptual clarity and consensus regarding the core domains and constructs to be measured such as "diabetes-related quality of life" [1].…”