Estimating the impact of changes in HbA1c, body weight and insulin injection regimen on health related quality-of-life: a time trade off study.

BACKGROUND: There are limited data on the potential short-term benefits associated with reductions in HbA1c levels, and understanding any immediate improvements in health related quality-of-life (HRQoL) through better glycaemic control may help inform diabetes management decisions. This time-trade-off (TTO) study investigated the short-term impact on HRQoL associated with three different aspects of diabetes management; HbA1c change, body weight change, and the complexity of treatment regimen. METHODS: The study was designed in three stages: Stage 1) Qualitative telephone interviews with people with type 2 diabetes (T2D) in Denmark who had experienced a decrease in their HbA1c level. Stage 2) A validation survey with people with T2D in Denmark to obtain quantifiable knowledge on the short-term effects of a change in HbA1c levels. Stage 3) TTO survey using health states based on results from stage 2. Respondents were either adults with T2D (Sweden) or from the general public (UK and Denmark) and were separately asked to evaluate seven health states through an internet-based survey. RESULTS: Results from 4060 respondents were available for the TTO analysis (UK n = 1777; Denmark n = 1799, Sweden n = 484). 'Well-controlled diabetes' was associated with utilities of 0.85-0.91 and 'not well-controlled diabetes' with utilities of 0.71-0.80 in all countries. Difference in utilities per HbA1c percentage point was smallest in Sweden and largest in Denmark (between 0.025-0.034 per HbA1c percentage point respectively). The treatment management health state associated with the lowest disutility was the once-daily insulin regimen. The disutility associated with per kg of weight change ranged from 0.0041-0.0073. CONCLUSIONS: Changes in HbA1c levels, insulin regimen and body weight are all likely to affect HRQoL for patients with T2D. A change in HbA1c is likely to have a short-term impact in addition to the effect on the development of long term diabetes complications. A treatment which has a simple regimen with fewer injections, and/or the need for less planning, and that causes weight loss or less weight gain, compared with other treatments, will have a positive impact on HRQoL.

Diminishing marginal disutility of hypoglycaemic events: results from a time trade-off survey in five countries.

INTRODUCTION: The negative impact of hypoglycaemic events on health-related quality of life (HRQoL) may be evaluated by attaching published disutilities to these events. It is suggested that the marginal negative impact of individual hypoglycaemic events on HRQoL may decrease as the overall frequency increases. METHODS: Using disutility values from a large-scale (>8,000 respondents), time trade-off (TTO) study, nonlinear regression curves were fitted to the total disutility of different frequencies of non-severe daytime and nocturnal hypoglycaemic events. Nonparametric bootstrapping was applied to characterise the uncertainty of the marginal disutility. RESULTS: Power function regression curves were estimated at U d = 0.0141x (0.3393) and U d = 0.0221x (0.3277). An increase from 0 to 1 hypoglycaemic event per year produced a utility decrease of 0.0141 and 0.0221 for non-severe daytime and nocturnal events, respectively. An increase from 25 to 26 events per year produced a marginal impact of 0.0006 and 0.0008 for non-severe daytime and nocturnal events, respectively. DISCUSSION: These data concur with the noted phenomenon of "first being worst" as regards hypoglycaemic events. This finding may reflect a coping mechanism on the part of patients, a maximum limit for trading off remaining lifetime or the nature of the study. CONCLUSION: Applying nonlinear functions to the TTO data might improve the precision of the measured impact of hypoglycaemic events.

Quality of life and patient preferences among Danish patients with ulcerative colitis - results from a survey study.

Objective: To explore health-related quality of life (HRQoL) and assess preferences for medical treatment attributes to obtain information of the relative importance of the different attributes in a Danish population with ulcerative colitis (UC).Methods: We used data from an online survey collected in March 2018 among people with self-reported UC. A total of 302 eligible respondents answered the HRQoL questionnaires (EuroQol-5 Dimensions (EQ-5D-5L) and the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)), and 212 also completed the discrete choice experiment (DCE). The probability of choosing an alternative from a number of choices in the DCE was estimated using a conditional logit model.Results: The respondents had an average SIBDQ score of 4.5 and an HRQoL score of 0.77, applying the EQ-5D-5L questionnaire. HRQoL correlated with disease severity, and the respondents had lower HRQoL than did a gender- and age-matched subset of the Danish population. The most important medical treatment attribute was efficacy within eight weeks. Additionally, respondents stated a preference for avoiding taking steroids, for fast onset of effect and for oral formulations.Conclusions: HRQoL correlates with disease severity, and patients with UC have lower HRQoL than the general population. The most important treatment attribute was efficacy, but patients also would like to avoid steroids, value fast onset of effect and prefer oral formulations.

Severity of fatigue in people with rheumatoid arthritis, psoriatic arthritis and spondyloarthritis - Results of a cross-sectional study.

BACKGROUND: Despite improvements in treatment for rheumatoid arthritis (RA), psoriatic arthritis (PsA) and spondyloarthritis (axSpA), several key unmet needs remain, such as fatigue. The objective of this study was to describe the severity of fatigue, disease characteristics and socioeconomic factors in people with RA, PsA and axSpA. METHODS: The study was designed as a cross-sectional survey collecting patient characteristics such as disease characteristics, socioeconomic factors and fatigue in people with RA, PsA and axSpA in Denmark. Respondents were consecutively recruited for the study over a six-month period in 2018 via routine visits to outpatient rheumatology clinics. Study nurses collected information on diagnosis, current disease-related treatment and disease activity from medical journals. People were invited to complete a questionnaire related to socioeconomic factors and containing the FACIT-Fatigue subscale. Descriptive statistics were analyzed using SAS. RESULTS: We invited 633 people to participate, and 488 (77%) completed the questionnaire. Women constituted 62% of respondents, and the mean age was 53.5 years. Respondents had on average been diagnosed between 11 and 15 years ago. Overall, 79% had no changes to their disease-related treatment during the past year, and the average disease activity as indicated by DAS28 for RA and PsA was 2.48 and 2.36, respectively, and BASDAI for axSpA was 28.40. Fatigue was present in all three diagnoses (mean: 34.31). The mean fatigue score varied from respondents answering that they suffered from no or little fatigue (mean: 45.48) to extreme fatigue (mean: 10.11). Analyses demonstrated that the respondents were not considerably different from nonrespondents, and the study population is considered representative compared with Danish RA and axSpA patients in the Danish National Rheumatology Registry, the DANBIO database. CONCLUSION: We found that the majority of the study population were fatigued (61%). They had low disease activity and few disease-related treatment changes.

Flexible insulin dosing improves health-related quality-of-life (HRQoL): a time trade-off survey.

PURPOSE: People with insulin-treated diabetes often face strict regimens with inflexible dose timing, frequent injections, and frequent self-measured blood glucose (SMBG) testing. The objective of this study was to estimate the health-related quality-of-life (HRQoL) impact of these aspects using time trade-off (TTO) methods. METHODS: HRQoL was examined via a TTO survey in the UK, Canada, and Sweden with separate analyses of 2465 respondents from the general population, 274 people with type 1 diabetes, and 417 people with type 2 diabetes. Respondents evaluated health states with diabetes, SMBG testing, and basal injections that were once-daily time flexible, once-daily at a fixed time, and twice-daily at a fixed time in a basal or basal-bolus regimen. RESULTS: Time-flexible basal injections were associated with 0.016 and 0.013 higher utility vs a fixed time of injection for basal-only and basal-bolus regimens, respectively, as evaluated by the general population. The diabetes respondents confirmed the basal-only results with 0.015 higher utility, but the difference in utility was non-significant for basal-bolus. Once-daily injections had higher utility compared with twice-daily injections for basal (0.039 and 0.042) and basal-bolus (0.022 and 0.021) regimens, as evaluated by the general population and people with diabetes, respectively. Increased frequency of SMBG negatively affected health utility. LIMITATIONS: This study has the limitation that it measures hypothetical health states rather than the HRQoL of people with these health states; furthermore, it could be suggested that the web-based nature of this survey is biased towards literate respondents with internet access and IT competence. CONCLUSIONS: Flexible dosing and fewer injections have a positive HRQoL impact, which potentially may enhance therapy adherence and could contribute to improved long-term outcomes. The impact of flexibility is greater in people treated with basal-only insulin regimens, and diminishes if bolus injections are part of the treatment regimen.