Patient-Reported Outcome Measures for Patients with Diabetes Mellitus Associated with Foot and Ankle Pathologies: A Systematic Review

Ortega-Ávila, Ana Belén; Cervera‐Garvi, Pablo; Ramos‐Petersen, Laura; Chicharro‐Luna, Esther; Gijón-Noguerón, Gabriel

doi:10.3390/jcm8020146

Cited by 23 publications

(27 citation statements)

References 64 publications

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“…This evaluation should include assessment of three overall domains (validity, reliability and responsiveness), for which consensus-based standards (COnsensusbased Standards for the selection of health Measurement Instruments [COSMIN]) can be applied [11]. The COSMIN methodology and standards derive from widespread international expert consensus [11,12] and have been applied to other PROM measures [13][14][15][16][17], but not yet to the assessment of the impact of hypoglycaemia on QoL.…”

Section: Introductionmentioning

confidence: 99%

The suitability of patient-reported outcome measures used to assess the impact of hypoglycaemia on quality of life in people with diabetes: a systematic review using COSMIN methods

et al. 2021

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Aims/hypothesis It is generally accepted that hypoglycaemia can negatively impact the quality of life (QoL) of people living with diabetes. However, the suitability of patient-reported outcome measures (PROMs) used to assess this impact is unclear. The aim of this systematic review was to identify PROMs used to assess the impact of hypoglycaemia on QoL and examine their quality and psychometric properties. Methods Systematic searches (MEDLINE, EMBASE, PsycINFO, CINAHL and The Cochrane Library databases) were undertaken to identify published articles reporting on the development or validation of hypoglycaemia-specific PROMs used to assess the impact of hypoglycaemia on QoL (or domains of QoL) in adults with diabetes. A protocol was developed and registered with PROSPERO (registration no. CRD42019125153). Studies were assessed for inclusion at title/abstract stage by one reviewer. Full-text articles were scrutinised where considered relevant or potentially relevant or where doubt existed. Twenty per cent of articles were assessed by a second reviewer. PROMS were evaluated, according to COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines, and data were extracted independently by two reviewers against COSMIN criteria. Assessment of each PROM’s content validity included reviewer ratings (N = 16) of relevance, comprehensiveness and comprehensibility: by researchers (n = 6); clinicians (n = 6); and adults with diabetes (n = 4). Results Of the 214 PROMs used to assess the impact of hypoglycaemia on QoL (or domains of QoL), seven hypoglycaemia-specific PROMS were identified and subjected to full evaluation: the Fear of Hypoglycemia 15-item scale; the Hypoglycemia Fear Survey; the Hypoglycemia Fear Survey version II; the Hypoglycemia Fear Survey-II short-form; the Hypoglycemic Attitudes and Behavior Scale; the Hypoglycemic Confidence Scale; and the QoLHYPO questionnaire. Content validity was rated as ‘inconsistent’, with most as ‘(very) low’ quality, while structural validity was deemed ‘unsatisfactory’. Other measurement properties (e.g. reliability) varied, and evidence gaps were apparent across all PROMs. None of the identified studies addressed cross-cultural validity or measurement error. Criterion validity and responsiveness were not assessed due to the lack of a ‘gold standard’ measure of the impact of hypoglycaemia on QoL against which to compare the PROMS. Conclusions/interpretation None of the hypoglycaemia-specific PROMs identified had sufficient evidence to demonstrate satisfactory validity, reliability and responsiveness. All were limited in terms of content and structural validity, which restricts their utility for assessing the impact of hypoglycaemia on QoL in the clinic or research setting. Further research is needed to address the content validity of existing PROMs, or the development of new PROM(s), for the purpose of assessing the impact of hypoglycaemia on QoL. Prospero registration CRD42019125153 Graphical abstract

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Section: Introductionmentioning

confidence: 99%

The suitability of patient-reported outcome measures used to assess the impact of hypoglycaemia on quality of life in people with diabetes: a systematic review using COSMIN methods

et al. 2021

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“…To date, no systematic review has summarized PROMs for diabetes, whether for diabetes in general or for subpopulations of patients with diabetes (eg, patients with type 2 diabetes), nor has a review consolidated the revisions made to existing PROMs for diabetes. Moreover, existing systematic reviews have focused on the psychometric properties of only certain categories of diabetes PROMs (eg, PROMs evaluating only health-related quality of life measures [8], PROMs for diabetes self-care [9], or PROMs in patients with diabetes associated with foot and ankle pathologies [10]) or the use of PROMs/association of PROMs with diabetes and its complications [11], even though such PROMs may be validated and applicable to a wider population of diabetes patients; for example, the Mexican version of the Diabetes Foot-Care Behavior Scale was validated in a population of patients with type 2 diabetes and not limited to patients with foot and ankle pathologies [12]. Therefore, we aimed to conduct a systematic literature review to identify studies investigating the measurement properties of PROMs validated in the population of patients with diabetes and evaluate the methodological quality and level of evidence relating to these measurement properties of PROMs.…”

Section: Introductionmentioning

confidence: 99%

Measurement Properties of Patient-Reported Outcome Measures for Diabetes: Systematic Review

Wee¹,

Kwan²,

Loh³

et al. 2021

J Med Internet Res

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Background The management of diabetes is complex. There is growing recognition of the use of patient-reported outcome measures (PROMs) as a standardized method of obtaining an outlook on patients’ functional status and well-being. However, no systematic reviews have summarized the studies that investigate the measurement properties of diabetes PROMs. Objective Our aims were to conduct a systematic review of studies investigating the measurement properties of diabetes PROMs by evaluating the methodological quality and overall level of evidence of these PROMs and to categorize them based on the outcome measures assessed. Methods This study was guided by the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) guidelines. Relevant articles were retrieved from the Embase, PubMed, and PsychINFO databases. The PROMs were evaluated with the COSMIN (COnsensus-based Standards for the selection of health Measurement Instruments) guidelines. Results A total of 363 articles evaluating the measurement properties of PROMs for diabetes in the adult population were identified, of which 238 unique PROMs from 248 studies reported in 209 articles were validated in the type 2 diabetes population. PROMs with at least a moderate level of evidence for ≥5 of 9 measurement properties include the Chinese version of the Personal Diabetes Questionnaire (C-PDQ), Diabetes Self-Management Instrument Short Form (DSMI-20), and Insulin Treatment Appraisal Scale in Hong Kong primary care patients (C-ITAS-HK), of which the C-PDQ has a “sufficient (+)” rating for >4 measurement properties. A total of 43 PROMs meet the COSMIN guidelines for recommendation for use. Conclusions This study identified and synthesized evidence for the measurement properties of 238 unique PROMs for patients with type 2 diabetes and categorized the PROMs according to their outcome measures. These findings may assist clinicians and researchers in selecting appropriate high-quality PROMs for clinical practice and research. Trial Registration PROSPERO International Prospective Register of Systematic Reviews CRD42020180978; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020180978.

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“…Previous literature reviews of QOL measures in diabetes are more focused on either the structure and psychometric properties of the scales, possibly outdated, or reviewing measures for more specific targets (e.g., diabetes with foot problems) [14,[16][17][18][19]].…”

Section: Introductionmentioning

confidence: 99%

Measuring the Quality of Life in Diabetic Patients: A Scoping Review

Palamenghi

Carlucci

Graffigna

2020

Journal of Diabetes Research

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Background. Diabetes mellitus is a widely diffused chronic condition which impacts on several aspects of patients’ lives. In the current clinical practice, the implementation in the clinical routine of monitoring systems of patients’ outcomes has led to an increased generation and use of several measures for the assessment of patients’ quality of life (QOL). Nevertheless, this construct appears to be particularly complex, and its operationalization is variable across different measures. The purpose of this paper is to offer an updated review of the diabetes-specific QOL measures present in scientific literature with a specific focus on the broad domains assessed. Methods. A scoping review was carried out with the purpose of identifying the existing measures in literature and describing their implicit representation of QOL in diabetes care. Five different databases (Scopus; Web of Science Core Collection; Medline; PsycInfo; and Cochrane Central Register of Controlled Trials) were searched with a string including validation studies of adult-only, diabetes-specific QOL measures. Each measure was then qualified according to its structure, a qualitative assessment of the broad domains of QOL it comprises, and finally an overview of the psychometric properties of its first validation. Results. 30 scales were identified and assessed. Theme analysis shows that QOL is operationalized with multidimensional surveys comprising of both mental, physical, and social health components. Some scales also consider the impact of societal attitudes, public policies, and context on QOL. Conclusion. Several self-report measures of QOL specifically developed for diabetic patients exist in scientific literature. The present scoping review reports scales structure, broad domains of QOL, and development purpose. This may help in understanding the concept of QOL in diabetic patients and may also serve the purpose of guiding the reader in the choice of the most appropriate instrument or in the development of a new one.

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Patient-Reported Outcome Measures for Patients with Diabetes Mellitus Associated with Foot and Ankle Pathologies: A Systematic Review

Cited by 23 publications

References 64 publications

The suitability of patient-reported outcome measures used to assess the impact of hypoglycaemia on quality of life in people with diabetes: a systematic review using COSMIN methods

The suitability of patient-reported outcome measures used to assess the impact of hypoglycaemia on quality of life in people with diabetes: a systematic review using COSMIN methods

Measurement Properties of Patient-Reported Outcome Measures for Diabetes: Systematic Review

Measuring the Quality of Life in Diabetic Patients: A Scoping Review

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