Cost‐effectiveness of the psycho‐educational blended (group and online) intervention HypoAware compared with usual care for people with Type 1 and insulin‐treated Type 2 diabetes with problematic hypoglycaemia: analyses of a cluster‐randomized controlled trial

Rondags, Stefanie M. P. A.; Tulder, Maurits W. van; Snoek, Frank J.; Bosmans, Judith E.

doi:10.1111/dme.13548

Cited by 7 publications

(17 citation statements)

References 29 publications

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“…In the HypoAware study, the HypoAware intervention (a blended, group and online psycho-educational intervention based on the evidence-based Blood Glucose Awareness Training) was compared to usual care among 137 participants (intervention group: n = 71; control group: n = 66) [55]. Resource use was measured from a societal perspective at 2, 4, and 6 months follow-up using cost questionnaires.…”

Section: Hypoaware Studymentioning

confidence: 99%

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The statistical approach in trial-based economic evaluations matters: get your statistics together!

Mutubuki

Alili

Bosmans

et al. 2021

BMC Health Serv Res

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Background Baseline imbalances, skewed costs, the correlation between costs and effects, and missing data are statistical challenges that are often not adequately accounted for in the analysis of cost-effectiveness data. This study aims to illustrate the impact of accounting for these statistical challenges in trial-based economic evaluations. Methods Data from two trial-based economic evaluations, the REALISE and HypoAware studies, were used. In total, 14 full cost-effectiveness analyses were performed per study, in which the four statistical challenges in trial-based economic evaluations were taken into account step-by-step. Statistical approaches were compared in terms of the resulting cost and effect differences, ICERs, and probabilities of cost-effectiveness. Results In the REALISE study and HypoAware study, the ICER ranged from 636,744€/QALY and 90,989€/QALY when ignoring all statistical challenges to − 7502€/QALY and 46,592€/QALY when accounting for all statistical challenges, respectively. The probabilities of the intervention being cost-effective at 0€/ QALY gained were 0.67 and 0.59 when ignoring all statistical challenges, and 0.54 and 0.27 when all of the statistical challenges were taken into account for the REALISE study and HypoAware study, respectively. Conclusions Not accounting for baseline imbalances, skewed costs, correlated costs and effects, and missing data in trial-based economic evaluations may notably impact results. Therefore, when conducting trial-based economic evaluations, it is important to align the statistical approach with the identified statistical challenges in cost-effectiveness data. To facilitate researchers in handling statistical challenges in trial-based economic evaluations, software code is provided.

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Section: Hypoaware Studymentioning

confidence: 99%

“…Tables describing baseline characteristics of the REAL ISE and HypoAware study populations are included in the Appendix (Supplementary Tables 1 and 2). For a detailed description of both studies, the reader is referred elsewhere [52,[55][56][57].…”

Section: Hypoaware Studymentioning

confidence: 99%

The statistical approach in trial-based economic evaluations matters: get your statistics together!

Mutubuki

Alili

Bosmans

et al. 2021

BMC Health Serv Res

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“…This study used data from two pragmatic cluster-randomized controlled trials performed in the Netherlands. Full details of the trials are described elsewhere (van Dijk et al, 2013;Wit, Rondags, Tulder, Snoek, & Bosmans, 2018). In brief, the first trial (referred to as depression study in this paper) assessed the cost-effectiveness of a program consisting of four sequential treatment steps to prevent major depression in comparison with usual care among patients with subthreshold depression symptoms.…”

Section: Datamentioning

confidence: 99%

“…In the diabetes study, it was administered at baseline and at 2, 4, and 6-month follow-up. Costs were measured from a societal perspective and included costs of the study interventions, health care utilization, medication, and lost productivity (absenteeism and presenteeism;van Dijk et al, 2013;Wit et al, 2018).…”

Section: Datamentioning

confidence: 99%

Comparing the EQ‐5D‐5L crosswalks and value sets for England, the Netherlands and Spain: Exploring their impact on cost‐utility results

et al. 2020

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This study compares the five-level EuroQol five-dimension questionnaire (EQ-5D-5L) crosswalks and the 5L value sets for England, the Netherlands, and Spain and explores the implication of using one or the other for the results of cost-utility analyses. Data from two randomized controlled trials in depression and diabetes were used. Utility value distributions were compared, and mean differences in utility values between the EQ-5D-5L crosswalk and the 5L value set were described by country. Quality-adjusted life years (QALYs) were calculated using the area-under-the-curve method. Incremental cost-effectiveness ratios (ICERs) were calculated, and uncertainty around ICERs was estimated using bootstrapping and graphically shown in cost-effectiveness acceptability curves. For all countries investigated, utility value distributions differed between the EQ-5D-5L crosswalk and 5L value set. In both case studies, mean utility values were lower for the EQ-5D-5L crosswalk compared with the 5L value set in England and Spain, but higher in the Netherlands. However, these differences in utility values did not translate into relevant differences across utility estimation methods in incremental QALYs and the interventions' probability of cost-effectiveness. Thus, our results suggest that EQ-5D-5L crosswalks and 5L value sets can be used interchangeably in patients affected by mild or moderate conditions. Further research is needed to establish whether these findings are generalizable to economic evaluations among severely ill patients. K E Y W O R D SEuroQol, utility, EQ-5D, EQ-5D-5L, crosswalk, value set, quality of life Ângela J. Ben, PhD, and Aureliano P. Finch, PhD, contributed equally to this work.

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“…Based on these findings, implementation of HypoAware in diabetes outpatient care is recommended. Although costeffectiveness could not be demonstrated within a 6-month period [43], costs of programme delivery, including maintaining the online platform, are modest and have not been a barrier to dissemination. Indeed, uptake of HypoAware in the Netherlands has increased substantially in recent years, with approximately 30 centres offering the programme to people at high risk of recurrent severe hypoglycaemia as part of standard care, with no or very small additional costs (€10) for the individual.…”

Section: What We Have Learned Over the Past 25 Years?mentioning

confidence: 99%

How has psycho‐behavioural research advanced our understanding of hypoglycaemia in type 1 diabetes?

et al. 2019

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Almost 100 years since the discovery of insulin, hypoglycaemia remains a barrier for people with type 1 diabetes to achieve and maintain blood glucose at levels which prevent long‐term diabetes‐related complications. Although hypoglycaemia is primarily attributable to the limitations of current treatment and defective hormonal counter‐regulation in type 1 diabetes, the central role of psycho‐behavioural factors in preventing, recognizing and treating hypoglycaemia has been acknowledged since the early 1980s. Over the past 25 years, as documented in the present review, there has been a substantial increase in psycho‐behavioural research focused on understanding the experience and impact of hypoglycaemia. The significant contributions have been in understanding the impact of hypoglycaemia on a person's emotional well‐being and aspects of life (e.g. sleep, driving, work/social life), identifying modifiable psychological and behavioural risk factors, as well as in developing psycho‐behavioural interventions to prevent and better manage (severe) hypoglycaemia. The impact of hypoglycaemia on family members has also been confirmed. Structured diabetes education programmes and psycho‐behavioural interventions with a focus on hypoglycaemia have both been shown to be effective in addressing problematic hypoglycaemia. However, the findings have also revealed the complexity of the problem and the need for a personalized approach, taking into account the individual's knowledge of, and emotional/behavioural reactions to hypoglycaemia. Evidence is emerging that people with persistent and recurrent severe hypoglycaemia, characterized by deeply entrenched cognitions and lack of concern around hypoglycaemia, can benefit from tailored cognitive behavioural therapy.

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Cost‐effectiveness of the psycho‐educational blended (group and online) intervention HypoAware compared with usual care for people with Type 1 and insulin‐treated Type 2 diabetes with problematic hypoglycaemia: analyses of a cluster‐randomized controlled trial

Abstract: Based on the present study, we conclude that HypoAware is not cost-effective compared to usual care. Further research in less well-resourced settings and more severely affected patients is warranted. (Clinical Trials Registry no: Dutch Trial Register NTR4538.).

Cited by 7 publications

References 29 publications

The statistical approach in trial-based economic evaluations matters: get your statistics together!

The statistical approach in trial-based economic evaluations matters: get your statistics together!

Comparing the EQ‐5D‐5L crosswalks and value sets for England, the Netherlands and Spain: Exploring their impact on cost‐utility results

How has psycho‐behavioural research advanced our understanding of hypoglycaemia in type 1 diabetes?

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