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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

Carlton, Jill, Leaviss, Joanna, Pouwer, Frans, Hendrieckx, Christel, Broadley, Melanie M, Clowes, Mark, McCrimmon, Rory J, Heller, Simon R and Speight, Jane 2021, 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, Diabetologia, pp. 1-13, doi: 10.1007/s00125-021-05382-x.

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Title 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
Author(s) Carlton, Jill
Leaviss, Joanna
Pouwer, Frans
Hendrieckx, ChristelORCID iD for Hendrieckx, Christel orcid.org/0000-0002-0075-828X
Broadley, Melanie M
Clowes, Mark
McCrimmon, Rory J
Heller, Simon R
Speight, JaneORCID iD for Speight, Jane orcid.org/0000-0002-1204-6896
Journal name Diabetologia
Start page 1
End page 13
Total pages 13
Publisher Springer
Place of publication Chichester, Eng.
Publication date 2021-02-02
ISSN 0012-186X
1432-0428
Keyword(s) Science & Technology
Life Sciences & Biomedicine
Endocrinology & Metabolism
COSMIN
Diabetes
Hypoglycaemia
Patient-reported outcome measures
Psychometric properties
Quality of life
Questionnaire
Systematic review
Summary 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
Notes In press
Language eng
DOI 10.1007/s00125-021-05382-x
Indigenous content off
Field of Research 1103 Clinical Sciences
1114 Paediatrics and Reproductive Medicine
1117 Public Health and Health Services
HERDC Research category C1 Refereed article in a scholarly journal
Free to Read? Yes
Persistent URL http://hdl.handle.net/10536/DRO/DU:30147810

Document type: Journal Article
Collections: Faculty of Health
School of Psychology
Open Access Collection
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.