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.

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.

The relationship between attentional bias to food and disordered eating in females with type 1 diabetes.

OBJECTIVE: Factors which may render females with type 1 diabetes mellitus (T1DM) vulnerable to disordered eating behavior or difficulties with dietary management require further investigation. Given prior associations observed between food-related attentional biases and eating behavior in groups without diabetes, this study explored the relationships between attentional bias to healthy and unhealthy pictorial food cues and disordered eating in young adult females with and without T1DM, aged 18-40yrs. METHODS: 97 participants (41 with T1DM, 56 without) completed an initial online survey assessing demographic and clinical information, and disordered eating via the Eating Disorders Examination- Questionnaire (EDE-Q). They subsequently attended an in-person session to complete a computer-based visual probe task to assess attentional bias to pictorial food cues. RESULTS: Analyses of Variance (ANOVAs) adjusting for age and body mass index showed a unique significant relationship in the group with T1DM whereby greater attentional bias scores away from unhealthy foods was associated with greater disordered eating. No relationship was observed in the group without diabetes. DISCUSSION: This study suggests that early attentional disengagement from food-related cues may be uniquely associated with eating-related outcomes for females with T1DM relative to those without diabetes. This should be further explored in future research with an aim to develop novel strategies for prevention and treatment of disordered eating behavior in this vulnerable group.

A Systematic Review and Meta-analysis of Executive Function Performance in Type 1 Diabetes Mellitus.

OBJECTIVE: The aims of the study were to examine the current evidence for executive function (EF) performance differences between groups with type 1 diabetes mellitus (T1DM) and nondiabetic control groups during adolescence and early adulthood and to explore the relationships between EF and diabetes-related risk factors. METHODS: A systematic review of the literature examining EF performance in groups with T1DM was conducted according to the PRISMA guidelines. Electronic database searches for published and unpublished literature yielded a final set of 26 articles after application of inclusion and exclusion criteria. A meta-analysis was conducted on a subset of these articles (n = 17) comparing EF performance in T1DM and control groups, across a total sample size of 1619. RESULTS: Sixteen of 26 studies found significantly lower EF on at least one task in groups with T1DM. Meta-analyses of the performance difference between T1DM groups and control groups without diabetes showed that inhibition (g = -0.28, p < .001), working memory (g = -0.34, p < .001), set-shifting (g = -0.31, p = .012), and overall EF performance across these domains (g = -0.42, p < .001) were all significantly lower in groups with T1DM. Performance on specific EF domains also seemed to be differentially associated with early age of diabetes onset, chronic hyperglycemia and its complications, and severe hypoglycemia. CONCLUSIONS: T1DM and its associated risk factors are related to subtle impairments across the inhibition, working memory, and set-shifting domains of EF. Lower EF may be a key factor contributing to behavioral and clinical problems experienced by individuals with T1DM.

Consistent Effects of Hypoglycemia on Cognitive Function in People With or Without Diabetes.

OBJECTIVE: Hypoglycemia poses an immediate threat for cognitive function. Due to its association with acute cognitive impairment, the International Hypoglycemia Study Group (IHSG) defines a blood glucose level <3.0 mmol/L as "level 2 hypoglycemia." In the current study we investigated whether having diabetes, type of diabetes, or hypoglycemia awareness moderates this association. RESEARCH DESIGN AND METHODS: Adults with type 1 diabetes with normal (n = 26) or impaired (n = 21) hypoglycemic awareness or with insulin-treated type 2 diabetes (n = 15) and age-matched control subjects without diabetes (n = 32) underwent a hyperinsulinemic-euglycemic-hypoglycemic glucose clamp (2.80 ± 0.13 mmol/L [50.2 ± 2.3 mg/dL]). At baseline and during hypoglycemia, calculation ability, attention, working memory and cognitive flexibility were measured with the Paced Auditory Serial Addition Test (PASAT) and the Test of Attentional Performance (TAP). RESULTS: For the whole group, hypoglycemia decreased the mean ± SD proportion of correct answers on the PASAT by 8.4 ± 12.8%, increased reaction time on the TAP Alertness task by 32.1 ± 66.6 ms, and increased the sum of errors and omissions on the TAP Working Memory task by 2.0 ± 5.5 (all P < 0.001). Hypoglycemia-induced cognitive declines were largely irrespective of the presence or type of diabetes, level of symptomatic awareness, diabetes duration, or HbA1c. CONCLUSIONS: IHSG level 2 hypoglycemia impairs cognitive function in people with and without diabetes, irrespective of type of diabetes or hypoglycemia awareness status. These findings support the cutoff value of hypoglycemia <3.0 mmol/L (<54 mg/dL) as being clinically relevant for most people with diabetes.

Executive function is associated with diabetes-specific disordered eating in young adults with type 1 diabetes.

OBJECTIVES: Disordered eating behavior in young adults with type 1 diabetes is overrepresented and associated with significant negative health consequences. Thus, determining the key correlates of these behaviors is essential. The aim of the present study was to determine the association between executive function and disordered eating in young adults with type 1 diabetes, relative to a control group without diabetes. METHODS: 74 young adults with type 1 diabetes and 201 demographically similar control participants completed an online survey containing the Eating Disorders Examination Questionnaire (EDE-Q), Diabetes Eating Problems Survey- Revised (DEPS-R), Behavior Rating Inventory of Executive Function- Adult version, Depression Anxiety and Stress Scales, and 3 subscales of the Family Environment Scale (independence, control, and cohesion). RESULTS: Hierarchical multiple regressions showed that lower executive function was associated with significantly greater disordered eating (as measured by the DEPS-R) over and above psychological and family functioning in the type 1 diabetes group (ΔR2 = 0.056, ß = 0.366, p = .031). The same relationship was not found when disordered eating was measured by the EDE-Q in either the diabetes group (ΔR2 = 0.049, ß = 0.342, p = .054), or the control group (ΔR2 = 0.010, ß = 0.136, p = .100). CONCLUSIONS: Executive function may play a greater role in the development and/or maintenance of disordered eating in groups with type 1 diabetes relative to those without. This relationship may contribute to the over-representation of eating problems in this clinical group, and may represent a target for prevention or intervention.