Assessing the impact of non-severe hypoglycemic events and treatment in adults: development of the Treatment-Related Impact Measure—Non-severe Hypoglycemic Events (TRIM-HYPO)

Brod, Meryl; Højbjerre, Lise; Bushnell, Donald M.; Hansen, Charlotte T.

doi:10.1007/s11136-015-1023-6

Cited by 10 publications

(11 citation statements)

References 39 publications

(46 reference statements)

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“…Hypoglycemia impacts emotional health, self-management, daily functioning and life quality. Hypoglycemia burden predicts care needs, clinical and quality of life outcomes [ 69 , 70 , 99 ] Confidence in ability to manage diabetes Confidence in being able to self-manage diabetes is a key goal Self-efficacy predicts support needs, self-management, clinical and quality of life outcomes and complements clinical and behavioral data [ 133 , 134 ] Confidence in access to person-centred diabetes care and support Feeling secure and confident in having quality medical care, relevant technologies and self-management support available is a key goal [ 42 , 135 ] …”

Section: Discussionmentioning

confidence: 99%

The participatory development of a national core set of person-centred diabetes outcome constructs for use in routine diabetes care across healthcare sectors

Skovlund

Troelsen

Klim³

et al. 2021

Res Involv Engagem

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Background This study sought to utilise participatory research methods to identify the perspectives of people with diabetes regarding which diabetes outcomes were most important to them. These findings were then used to support an expert working group representing multiple health sectors and healthcare disciplines and people with diabetes to establish a core set of patient-important outcome constructs for use in routine diabetes care. Methods 26 people with diabetes and family members were recruited through purposive sampling to participate in interviews, focus groups, voting and plenary activities in order to be part of identifying outcome constructs. Content and qualitative analysis methods were used with literature reviews to inform a national multi-stakeholder consensus process for a core set of person-centred diabetes outcome constructs to be used in routine diabetes care across health care settings. Results 21 people with diabetes and 5 family members representing type 1 and 2 diabetes and a range of age groups, treatment regimens and disease burden identified the following patient-reported outcome constructs as an important supplement to clinical indicators for outcome assessment in routine diabetes care: self-rated health, psychological well-being, diabetes related emotional distress and quality of life, symptom distress, treatment burden, blood sugar regulation and hypoglycemia burden, confidence in self-management and confidence in access to person-centred care and support. Consensus was reached by a national multi-stakeholder expert group to adopt measures of these constructs as a national core diabetes outcome set for use in routine value-based diabetes care. Conclusions We found that patient-reported outcome (PRO) constructs and clinical indicators are needed in core diabetes outcome sets to evaluate outcomes of diabetes care which reflect key needs and priorities of people with diabetes. The incorporation of patient-reported outcome constructs should be considered complementary to clinical indicators in multi-stakeholder value-based health care strategies. We found participatory research methods were useful in facilitating the identification of a core prioritised set of diabetes outcome constructs for routine value-based diabetes care. The use of our method for involving patients may be useful for similar efforts in other disease areas aimed at defining suitable outcomes of person-centred value-based care. Future research should focus on developing acceptable and psychometrically valid measurement instruments to evaluate these outcome constructs as part of routine diabetes care.

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Section: Discussionmentioning

confidence: 99%

The participatory development of a national core set of person-centred diabetes outcome constructs for use in routine diabetes care across healthcare sectors

Skovlund

Troelsen

Klim³

et al. 2021

Res Involv Engagem

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“…Nonsevere hypoglycemic events (NSHEs), self-treated hypoglycemia (18), may be experienced by 24-85% of patients with diabetes, particularly among insulin users (18)(19)(20). Each patient in the DIAMOND trial was required to wear a blinded CGM device to record glucose concentration (invisible to the patients) for 2 weeks before randomization and for a week before the 12-and 24-week visits.…”

Section: Nonsevere Hypoglycemic Eventsmentioning

confidence: 99%

“…The cost of a NSHE episode used in the study was $20.32, including $11.09 in direct medical costs and $9.23 in indirect costs (35,36). Lowering NSHEs not only reduces the risk of subsequent severe hypoglycemia (37) but also improves QoL, including psychological well-being, adherence to treatment regimens, work productivity, and quality and quantity of sleep (6,18,19).…”

Section: Psamentioning

confidence: 99%

Cost-effectiveness of Continuous Glucose Monitoring for Adults With Type 1 Diabetes Compared With Self-Monitoring of Blood Glucose: The DIAMOND Randomized Trial

et al. 2018

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“… 21 Items are rated on a 7-point scale (from 1= very positive impact to 7= very negative impact ) or participants can select ‘not applicable’ (N/A). All seven items and the 7-point scale were retained in the HIP12, and five items were added, based on qualitative research 12 13 and consultation with the PAC, to assess the impact of hypoglycemia on the following domains of life: sleep, sex life, independence, ability to be spontaneous, and ability to keep fit/be active. Composite scores are calculated by averaging the scores across applicable items, with scores <4 indicating a positive impact, a score of 4 no impact, and a score of >4 a negative impact of hypoglycemia on QoL.…”

Section: Methodsmentioning

confidence: 99%

“…Recent qualitative studies show that hypoglycemia impacts an individual’s QoL in many domains, such as relationships, work or studies, sleep, leisure, and physical activities. 12 13 Person-reported outcome measures (PROMs) can be used to quantify the extent of these impacts. However, recent systematic reviews of the quantified impact of hypoglycemia on QoL among adults with T1D or T2D showed substantial heterogeneity in methods used to assess both hypoglycemia and QoL outcomes.…”

Section: Introductionmentioning

confidence: 99%

The 12-Item Hypoglycemia Impact Profile (HIP12): psychometric validation of a brief measure of the impact of hypoglycemia on quality of life among adults with type 1 or type 2 diabetes

Broadley

Chatwin

Søholm

et al. 2022

BMJ Open Diab Res Care

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IntroductionThe aim of this study was to determine the psychometric properties of the 12-Item Hypoglycemia Impact Profile (HIP12), a brief measure of the impact of hypoglycemia on quality of life (QoL) among adults with type 1 (T1D) or type 2 diabetes (T2D).Research design and methodsAdults with T1D (n=1071) or T2D (n=194) participating in the multicountry, online study, ‘Your SAY: Hypoglycemia’, completed the HIP12. Psychometric analyses were undertaken to determine acceptability, structural validity, internal consistency, convergent/divergent validity, and known-groups validity.ResultsMost (98%) participants completed all items on the HIP12. The expected one-factor solution was supported for T1D, T2D, native English speaker, and non-native English speaker groups. Internal consistency was high across all groups (ω=0.91–0.93). Convergent and divergent validity were satisfactory. Known-groups validity was demonstrated for both diabetes types, by frequency of severe hypoglycemia (0 vs ≥1 episode in the past 12 months) and self-treated episodes (<2 vs 2–4 vs ≥5 per week). The measure also discriminated by awareness of hypoglycemia in those with T1D.ConclusionsThe HIP12 is an acceptable, internally consistent, and valid tool for assessing the impact of hypoglycemia on QoL among adults with T1D. The findings in the relatively small sample with T2D are encouraging and warrant replication in a larger sample.

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Assessing the impact of non-severe hypoglycemic events and treatment in adults: development of the Treatment-Related Impact Measure—Non-severe Hypoglycemic Events (TRIM-HYPO)

Abstract: Study findings demonstrate that the final, 33-item TRIM-HYPO is reliable and valid and may be useful for assessing impacts related to NSHEs in research and clinical practice.

Cited by 10 publications

References 39 publications

The participatory development of a national core set of person-centred diabetes outcome constructs for use in routine diabetes care across healthcare sectors

The participatory development of a national core set of person-centred diabetes outcome constructs for use in routine diabetes care across healthcare sectors

Cost-effectiveness of Continuous Glucose Monitoring for Adults With Type 1 Diabetes Compared With Self-Monitoring of Blood Glucose: The DIAMOND Randomized Trial

The 12-Item Hypoglycemia Impact Profile (HIP12): psychometric validation of a brief measure of the impact of hypoglycemia on quality of life among adults with type 1 or type 2 diabetes

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