Clinical outcome constructs/indicators | ||||
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A1c, BGM/FMM measurements, clinician defined and registered indicators for presence of diabetes foot complications, incl. amputation, retinopathy, neuropathy, nephropathy, cardiovascular disease, ketoacidosis, severe hypoglycemia, hospitalization rate | ||||
Patient reported outcome constructs | ||||
Core diabetes outcome constructs | Relevance for PWD | Mutability | Clinical significance | Construct characteristics referred to in working group |
Health outcomes | ||||
1. Self-reported health and functioning | 10 | 6 | 10 | Self-reported physical health and functioning |
2. Psychological well-being | 10 | 6 | 10 | Positive psychological well-being, mental health and risk of depression |
3. Diabetes related distress | 10 | 3 | 9 | Diabetes-specific emotional impacts, frustrations, worries, fears, limitations, and daily burden |
4. Impact of diabetes on life quality | NR | NR | NR | Impact of diabetes on quality of life beyond emotional distress. Detailing of this was out of scope |
5. Somatic symptom distress | 10 | 5 | NR | Neuropathic pain. Sexual dysfunction. Sleep problems, fatigue, cognitive deficiency, Chest pain, cardiovascular symptoms, Hypo- and hyperglycemia |
Process of care and treatment | ||||
6. Hypoglycemic episodes requiring assistance | 10 | 10 | 10 | Hypoglycemic episodes requiring assistance from others were important to register through self-report to complement clinical registration |
7. Burden of daily diabetes treatment | 10 | 8 | 10 | Perceived burden, hassles and side effects related to prescribed medical treatment regimen and requirements for daily monitoring and planning |
8. Burden of hypoglycemia | 9 | 9 | 9 | Quality of life, emotional and behavioral burden of risks and symptoms of hypo-glycemia. Impacts on well-being, lifestyle, self-care, daily life, work/study, social and leisure life. A priority subconstruct of 7. Mostly relevant to insulin users |
Sustainability factors | ||||
9. Confidence in ability to perform diabetes self-management | 10 | 7 | 10 | Confidence in or ability to manage diabetes well: Diet, exercise, medicine, well-being, blood sugar monitoring, active role in own care decisions, navigating the care system, health competency |
10. Confidence and comfort in adequate access to person-centred diabetes care | 10 | 7 | 10 | Feeling secure and confident in having available access to quality medical care, relevant technologies and self-management support Getting quality person-centred diabetes care; HCPs listening and communicating effectively, involving PWD in care decisions |