Background
Methods
Stage 1 – telephone interviews
Stage 2 – validation survey
Stage 3 – TTO survey
Well-controlled diabetes | Not well-controlled diabetes |
---|---|
Imagine that you have diabetes as described. | Imagine that you have diabetes as described. |
Imagine that you succeed in keeping your treatment plan. Your doctor has told you that your average blood sugar is on target. Therefore: | However, for some time you have had trouble following your treatment plan. Your doctor has told you that your average blood sugar is higher than it should be. As a consequence: |
• You rarely feel excessive thirst and rarely have to urinate more often, neither during the day nor during the night. • You rarely drink a lot. • A minor problem for you is feeling scared and depressed thinking about living with diabetes. • Keeping your blood sugar at a good level requires constant focus on your lifestyle. | • You sometimes feel excessive thirst and have to urinate more often, during both the day and the night. • You sometimes also drink a lot. • Sometimes you feel tired and without energy. • A problem for you is feeling scared and depressed thinking about living with diabetes. • You wish your average blood sugar were lower, but it would require several lifestyle changes and you do not want diabetes to control your life. |
Imagine what it would be like for you to live with diabetes every day for the rest of your life. | Imagine what it would be like for you to live with diabetes every day for the rest of your life. |
Health state | Description |
---|---|
Injection twice daily including planning | • Imagine that you have well-controlled diabetes as described. • In order to control your blood sugar level, you must give yourself two insulin injections every day using two different pens. One injection should be taken in the morning. The other should be taken in connection with a large meal. • The second insulin dose should fit the type and size of your meals as well as your activity level. Therefore you have to plan either to eat roughly the same type and size of meals or ad- just your insulin doses every day. • Imagine what it would be like for you to live like this every day for the rest of your life. |
Injection four times daily including planning | • Imagine that you have well-controlled diabetes as described. • In order to control your blood sugar level, you must give yourself four insulin injections every day using two different pens. • One injection should be taken independent of meals at the same time every day. Using the other pen you give yourself insulin injections with each of your 3 largest meals during the day (breakfast, lunch and dinner). • These three insulin doses should fit the type and size of your meals as well as your activity level. Therefore you have to plan either to eat roughly the same type and size of meals or ad- just your insulin doses accordingly. • Imagine what it would be like for you to live like this every day for the rest of your life. |
Injection once daily | • Imagine that you have well-controlled diabetes as described. • In order to control your blood sugar level, you must give yourself one insulin injection every day. • The injection must be taken at approximately the same time every day. • Imagine what it would be like for you to live like this every day for the rest of your life |
Injection twice daily | • Imagine that you have well-controlled diabetes as described. • In order to control your blood sugar level, you must give yourself two injections every day using two different pens (one of which is insulin). • Both injections must be taken at approximately the same time every day. • Imagine what it would be like for you to live like this every day for the rest of your life. |
Health state | Description |
---|---|
Gain 5 kg | • Imagine that you have well-controlled diabetes as described. • The doctor changes your medication and you gain 5 kg without changing your lifestyle. • Imagine what it would be like for you to live like this every day for the rest of your life. |
Gain 2 kg | • Imagine that you have well-controlled diabetes as described. • The doctor changes your medication and you gain 2 kg without changing your lifestyle. • Imagine what it would be like for you to live like this every day for the rest of your life. |
Lose 2 kg | • Imagine that you have well-controlled diabetes as described. • The doctor changes your medication and you lose 2 kg without changing your lifestyle. • Imagine what it would be like for you to live like this every day for the rest of your life. |
Lose 5 kg | • Imagine that you have well-controlled diabetes as described. • The doctor changes your medication and you lose 5 kg without changing your lifestyle. • Imagine what it would be like for you to live like this every day for the rest of your life. |
Health state | Each respondent evaluated |
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Warm-up health state | Diabetes derived from previous work. Not used. |
HbA1c | Well-controlled diabetes |
Not well-controlled diabetes | |
(The order of the two health states were randomised) | |
Weight | 1 health state associated with weight gain (2 kg or 5 kg randomised) |
1 health state associated with weight loss (2 kg or 5 kg randomised) | |
(The order of the two health states were randomised) | |
Regimen | Two randomly selected out of the four health states (i.e. injection twice daily including planning, injection four times daily including planning, injection once daily, injection twice daily |
Statistical analysis
Estimation of HRQoL impact per HbA1c point
Estimation of HRQoL impact from insulin regimen features
Estimation of HRQoL impact of body weight changes
Results
Stage 1 – telephone interviews
Stage 2 – validation survey
Symptom | Results |
---|---|
Excessive thirst | Significant association between change in the frequency of experiencing excessive thirst and change in HbA1c (p < 0.0001). |
Frequent urination (day and night) | Significant association between change in the frequency of experiencing frequent urination and change in HbA1c (p < 0.0001, p = 0.0005 for day and night respectively) |
Fatigue/extreme tiredness and tiredness and lack of energy | Significant association between change in the frequency of experiencing fatigue symptoms and change in HbA1c (p < 0.0001 and p = 0.0001 for tiredness/lack of energy and fatigue/extreme tiredness respectively). |
Psychological | |
Feeling scared when thinking about living with diabetes | Significant association between feeling scared…” and change in HbA1c (p = 0.0328). The p value for the association between “feeling depressed…” and change in HbA1c was p = 0.0557. |
Feeling depressed when thinking about living with diabetes | |
Wishing to reduce HbA1c
| The higher the current HbA1c level, the more the respondents wanted to reduce their HbA1c level (p < 0.0001). |
Stage 3 – TTO survey
UK | Denmark | Sweden | |
---|---|---|---|
N = 1777a
|
N = 1799a
|
N = 484b
| |
Male (%) | 50 | 50 | 63 |
Age, years (mean) | 43.5 (14.5) | 45.5 (15.8) | 63.8 (9.2) |
BMI kg/m2 (mean) | 26.1 (5.7) | 26.2 (5.4) | 30.1 (5.3) |
Treatment with oral anti-diabetic drugs (%) | - | - | 87 % |
Insulin treatment (%) | - | - | 34 % |
Diabetes duration, years (mean) | - | - | 9.5 (7.0) |
Duration of insulin treatment (mean years) | - | - | 7.5 (6.6) |
Currently employed (%) | 59 | 52 | 31 |
HbA1c health states
UKa
| Denmarka
| Swedenb
| |||||||
---|---|---|---|---|---|---|---|---|---|
Utility value | Low (2.5 %) | High (97.5 %) | Utility value | Low (2.5 %) | High (97.5 %) | Utility value | Low (2.5 %) | High (97.5 %) | |
HbA1c change (per percentage point) | 0.033 | 0.031 | 0.035 | 0.034 | 0.032 | 0.035 | 0.025 | 0.022 | 0.028 |
Weight change | |||||||||
Per kg | 0.0073 | 0.0065 | 0.0081 | 0.0041 | 0.0036 | 0.0046 | 0.0068 | 0.0057 | 0.0081 |
Per BMI-unit | 0.021 | 0.018 | 0.023 | 0.012 | 0.011 | 0.014 | 0.021 | 0.017 | 0.024 |
Insulin regimen | |||||||||
Once daily vs twice daily | 0.020 | 0.010 | 0.031 | 0.021 | 0.014 | 0.027 | 0.015 | 0.0001 | 0.029 |
Once daily vs twice daily planning | 0.046 | 0.035 | 0.058 | 0.043 | 0.036 | 0.051 | 0.038 | 0.021 | 0.054 |
Once daily vs four times daily planning | 0.070 | 0.057 | 0.082 | 0.084 | 0.075 | 0.093 | 0.109 | 0.086 | 0.133 |
Twice daily vs twice daily planning | 0.026 | 0.014 | 0.037 | 0.022 | 0.015 | 0.030 | 0.023 | 0.006 | 0.040 |
Twice daily vs four times daily planning | 0.049 | 0.037 | 0.062 | 0.064 | 0.055 | 0.072 | 0.095 | 0.071 | 0.118 |
Twice daily planning vs four times daily planning | 0.023 | 0.010 | 0.037 | 0.041 | 0.031 | 0.051 | 0.071 | 0.047 | 0.096 |
2 %, 5 % and 10 % cut off criteria | Different cut-off criteria (2.5 % cut off) | |||||
---|---|---|---|---|---|---|
2 % cut off | 5 % cut off | 10 % cut off | Diff. 3.5 % | Diff. 4.2 % | Diff. 4.7 % | |
UK | 0.144 | 0.139 | 0.130 | 0.038 | 0.033 | 0.029 |
Denmark | 0.147 | 0.141 | 0.131 | 0.038 | 0.034 | 0.025 |
Sweden | 0.110 | 0.106 | 0.098 | 0.029 | 0.030 | 0.023 |