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

Abstract

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

State of the Art of Patient-reported Outcomes in Acromegaly or GH Deficiency: A Systematic Review and Meta-analysis

“…While some studies used well-defined PROMs to measure PROs, a large proportion of the studies in patients with acromegaly assessed a standardized set of symptoms, without clear definition of a PRO. The use of nondisease-specific or unvalidated PROs has also been observed in other areas, such as diabetes mellitus ( 34 ), and oncology ( 35 ). This is a point of concern, since validation of PROMs is important to ensure their relevance, validity, reliability, and sensitivity to change (ie, responsiveness) ( 36 ).…”

Measuring carer quality of life in Duchenne muscular dystrophy: a systematic review of the reliability and validity of self-report instruments using COSMIN

“…This review is not without its limitations. Whilst the methodological approach adopted is recognised and robust, it does have some limitations, as previously noted [ 16 , 20 ]. Firstly, the COSMIN appraisal tools assume a worst score counts system.…”

“…This systematic review has been designed to evaluate the content and psychometric properties of instruments used to measure QoL in informal carers of people with DMD using the COSMIN approach [ 12 , 15 ]. COSMIN methodology is becoming increasingly used within systematic reviews evaluating the quality of QoL measures in particular health contexts [ 13 , 16 – 19 ], including in a recent review of self-report measures used to assess QoL in people with DMD [ 20 ], which contributed to the rationale for the development of a new condition-specific QoL measure in this population [ 21 ].…”

Changes in quality of life following hypoglycaemia in adults with type 2 diabetes: A systematic review of longitudinal studies

“…Further longitudinal research is needed targeting more varied facets of QoL, particularly in the social domain. Research delineating impacts on individual facets of QoL based on hypoglycaemic severity will also be important for improving existing measures, 50 developing new hypoglycaemia‐specific measures which better capture the breadth of QoL and designing targeted interventions aimed at improving QoL on an outcome‐by‐outcome basis.…”