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Background and rationale Obesity is associated with the development and progression of many diseases. Understanding and management of obesity have become increasingly important; however, a knowledge gap remains between how healthcare providers (HCPs) consider weight‐loss treatment and the importance of weight loss for improving obesity‐related diseases. Objective The objective of this study was to investigate how HCPs assess obesity, how they interpret the relationship between obesity and 12 recognized co‐morbidities of obesity (excluding diabetes), and their view about the value of various weight‐loss therapies. Methods This was a cross‐sectional, non‐interventional, descriptive study. Participants were medical doctors (HCPs) from eight European countries. Results Eighty‐nine percent of the 197 HCPs that completed the survey considered obesity a disease. For most of the 12 obesity‐related diseases under consideration, a majority of HCPs agreed that weight loss could reverse the disease or prevent progression. Among HCPs who have recommended weight loss, lifestyle interventions were by far the most common recommendation. However, more than three out of four HCPs stated that they would be likely to prescribe anti‐obesity medications if available and reimbursed. Conclusion Most HCPs in this survey consider obesity a disease that needs to be treated. However, the majority of HCPs appear to prefer recommending lifestyle changes, although it is well documented that weight loss obtained by lifestyle changes is difficult to maintain. These results underscore the need for improved education of HCPs involved in the treatment of obesity‐related diseases., Visual Abstract

We used the Danish National Health Registers to conduct a study on the prevalence of obesity-related comorbidities in Danish citizens who have been diagnosed with obesity at a Danish hospital. This was a retrospective observational study with a population comprising all Danish citizens (≥18 years) who have been registered with a specific obesity class diagnosis in the Danish National Patient Register between 2002 and 2018. A total of 86 980 persons with hospital-diagnosed obesity were included in the study population. To investigate how the risk of having comorbidities varies with the degree of obesity, we applied adjusted logistic regression to estimate the odds ratio of having one of the following predefined comorbidities for people with a BMI in obesity classes II and III compared with people with a BMI in obesity class I: type 2 diabetes, ischaemic heart disease, non-alcoholic steatohepatitis and non-alcoholic fatty liver disease, hip and knee osteoarthritis, obstructive sleep apnoea and asthma. Comorbidities were defined from ICD-10 diagnosis codes and prescription medication utilization. The odds ratio for obstructive sleep apnoea (OR 1.86 and OR 3.0), type 2 diabetes (OR 1.68 and OR 2.26), hip and knee osteoarthritis (OR 1.29 and OR 1.54) and asthma (OR1.13 and OR 1.25) increased significantly with obesity class (obesity class II relative to I and III relative to I, respectively). The odds ratio of having had at least one comorbidity was estimated to be 1.52 for people with a BMI in obesity class II and 2.10 for people with a BMI in obesity class III compared with people in obesity class I. The risk of obstructive sleep apnoea, type 2 diabetes, hip and knee osteoarthritis, and asthma increased significantly with increasing BMI, highlighting the importance of preventing further weight gain even in individuals who are already living with obesity.

Purpose We aimed to estimate the total cost of bariatric surgery in Denmark. Materials and Methods The study population included all Danish citizens ≥ 18 years who had received bariatric surgery, identified in the Danish National Patient Register in the period from 2002 to 2018. Patients who had received bariatric surgery were matched with three controls on gender, year of birth, and region of residence. A difference-in-difference approach was used to estimate the healthcare costs attributable to bariatric surgery from 3 years before to 5 years after surgery. Results Total healthcare costs for cases receiving bariatric surgery during the first 5 years following surgery amounted to EUR 32,899, and EUR 16,651 for their matched controls. Thereby, the difference in total healthcare costs (EUR 16,248) between persons receiving bariatric surgery and their matched controls was 2.2 times the DRG rate for the surgery itself (EUR 7387). Moreover, the results suggest that receiving bariatric surgery led to a total increase in gross earnings of EUR 5970 (5%) and a total reduction in receipt of transfer payments of EUR 4488 (12%) in the period up until 5 years after surgery. Conclusion The results showed a significant and persistent increase in healthcare costs for people with obesity receiving bariatric surgery during the first 5 years after surgery. We also found that bariatric surgery was associated with increased attachment to the labor market. Graphical abstract

Peristomal skin complications (PSCs) and leakages are major issues for people living with a stoma. The purpose of this study is to understand how these stoma-linked complications impact health-related quality of life (HRQoL) in a UK population. The study used time trade-off (TTO) methodology to quantify health state utilities associated with two stoma-related complications: PSC and leakages. Respondents assessed 10 different health states with different PSC severity levels (no, mild, moderate or severe PSC) and frequencies of leakage events (2, 12 or 48 leakages onto clothes per year, and no leakage due to a digital solution). The average disutility value for each health state was also assessed. The study was conducted via a web-based survey in the UK adult general population. The analysis included 758 respondents. Respondents considered living with a stoma with no PSC to be more favorable than the other health states. Severe pain, itching and/or burning (PIB) was associated with the largest disutility compared to no PSC. The disutility (0–1 scale) compared to no PSC was 0.287 (p < .0001), 0.106 (p < .0001) and 0.025 (p=.0005) for PIB scores of 8, 5 and 2, respectively, on a 1–10 scale. More frequent leakage events were associated with lower utility. The utility decreases compared to no PSC were 0.114 (p < .0001), 0.057 (p < .0001) and 0.022 (p < .0001) for 48, 12 and 2 leakage events per year, respectively. The health state with a digital notification solution that notifies the user before a leakage event happens was considered as good as no PSC. Experiencing mild, moderate, and severe levels of PSC or leakage onto clothes is associated with a significant reduction in HRQoL compared to no PSC and/or no leakage. Stoma appliances that reduce the skin complications or keep leakage from reaching the clothes are likely to improve HRQoL.

Introduction: The Danish national health registers were used to investigate the economic burden of obesity, associated costs of comorbidities and a breakdown into direct and indirect costs. Methods: The study population comprised all Danish adult citizens registered with a hospital diagnosis of obesity in the Danish National Patient Register between 2002 and 2018. Cases were matched with five controls via the Danish Civil Registration System. We estimated the difference in total healthcare costs and indirect costs between cases and controls and the difference in healthcare resource utilization. In a sub-analysis, we estimated total healthcare costs for persons who had been registered with one or more of 11 predefined comorbidities. Results: People with obesity experienced a statistically significant twofold increase in average direct healthcare costs per year (EUR 5,934), compared with controls (EUR 2,788) and had statistically significantly higher indirect costs compared to controls. Total healthcare costs for people with obesity and one or more of the 11 comorbidities were 91.7%–342.8% higher than total healthcare costs of the population with obesity but none of the 11 comorbidities. Conclusion: Obesity was associated with an increase in both direct and indirect costs. The presence of comorbidities was associated with additional healthcare costs. Key points: Obesity is associated with an increase in direct and indirect costs in Denmark. Comorbidities are associated with additional healthcare costs.

Mike Tankersley,1,2 Tonya Winders,3,4 Mark Aagren,5 Henrik Brandi,5 Mikkel Hasse Pedersen,6 Anne Sofie Ledgaard Loftager,6 Mette Bøgelund6 1Departments of Medicine, Pediatrics and Otolaryngology, University of Tennessee Health Science Center, Memphis, TN, USA; 2The Tankersley Clinic, Memphis, TN, USA; 3Allergy & Asthma Network, Vienna, VA, USA; 4Global Allergy & Airways Patient Platform, Vienna, Austria; 5Department of Global Market Access & Public Affairs, ALK, Hørsholm, Denmark; 6Incentive Denmark, Holte, DenmarkCorrespondence: Mette Bøgelund Tel +45 2916 1222Email mb@incentive.dkBackground: People with allergic rhinitis (AR) who are not controlled on conventional therapy can be treated using allergy immunotherapy (AIT) administered as tablets, injections or drops. In the US, the use of sublingual immunotherapy as tablets (SLIT-tablets) is limited in comparison to subcutaneous immunotherapy (SCIT).Objective: This study investigated patients’ preference for SLIT-tablets vs monthly or weekly SCIT from a US patient perspective.Methods: We carried out a discrete choice experiment (DCE) consisting of two blocks with eight choice sets. Adults and caregivers of children with moderate-to-severe AR were included if they had not previously or were not currently receiving AIT. Three attributes were included in the design: the mode and frequency of administration, the risk of systemic reactions and the co-payment.Results: A total of 724 adults with AR and 665 caregivers of children with AR were included in the study. Both adults and caregivers had a significant preference for SLIT-tablets compared with both weekly and monthly injections and for less risk of anaphylactic shock. Caregivers were more risk-averse than adults when choosing their treatment, and the younger the child, the more risk-averse the caregiver. The preference for SLIT-tablets was found for both monoallergic and polyallergic adults and caregivers of monoallergic and polyallergic children. Respondents not wanting AIT for free were more risk-averse than those indicating that they wanted AIT for free.Conclusion: Our findings suggest that SLIT-tablets is the preferred route of administration for AIT among adults and caregivers of children with AR.Keywords: allergic rhinitis, allergy immunotherapy, discrete choice experiment, patient preferences, subcutaneous immunotherapy, sublingual immunotherapy

The aim of this study was to investigate the time use and both direct and indirect costs associated with subcutaneous immunotherapy (SCIT) for adults with allergic rhinitis (AR) and caregivers of children with AR in the US.We conducted a survey to assess the retrospective time use and direct costs of SCIT. The populations surveyed included adults and caregivers of children (aged 5-17) with symptomatic AR of moderate or higher severity who are currently receiving or have previously started allergy immunotherapy (AIT). The retrospectively collected, self-reported time consumption and direct costs per clinic visit when receiving SCIT were assessed as well as the productivity loss associated with SCIT. Data were analyzed using univariate descriptive statistics.The study included 106 adults with AR and 191 caregivers of children with AR. We found that the median time spent per visit to the clinic was 50 min for both groups, including travel time and time at the clinic. The direct costs related to each visit included parking fees, road tolls and other costs. Adults spent $10 on parking, $9 on tolls and $10 on other costs. Finally, a median of 4 h of work was missed for both the adult patients and the adults accompanying a child.We found that SCIT is associated with substantial direct patient costs and productivity loss for both adults with AR and caregivers of children with AR.

Summary Excess weight is associated with severe outcomes of coronavirus disease 2019 (COVID‐19). We aimed to estimate the total secondary care costs by body mass index (BMI, kg/m2) category when hospitalized due to COVID‐19 in Europe during the first wave of the pandemic from January to June 2020. Building a health‐care cost model, this study aimed to estimate the total costs of COVID‐19. Information on risk of hospitalization, admission to intensive care unit (ICU) and risk of ventilation were based on published data. Average cost per patient and in total were calculated based on risks of admission to ICU, risk of invasive mechanical ventilation and length of hospital stay when hospitalized and published costs associated with hospitalization. The total direct costs of secondary care during the first wave of COVID‐19 in Europe were estimated at EUR 13.9 billon, whereof 76% accounted for treating people with overweight and obesity. The average cost per hospital admission increased with BMI, from EUR 15831 for BMI

Andrei Krassioukov,1,2 Yasuhiko Igawa,3 Márcio Augusto Averbeck,4 Helmut Madersbacher,5 Andrew J Lloyd,6 Mette Bøgelund,7 Nikesh Thiruchelvam8 1University of British Columbia, International Collaboration On Repair Discoveries (ICORD), Vancouver, British Columbia, Canada; 2Division of Physical Medicine and Rehabilitation, Department of Medicine, G.F. Strong Rehabilitation Centre, Vancouver, British Columbia, Canada; 3Department of Continence Medicine, The University of Tokyo, Graduate School of Medicine, Tokyo, Japan; 4Head of Neuro-Urology Unit, Moinhos de Vento Hospital, Porto Alegre, Brazil; 5Department of Neurology, Medical University Innsbruck, Innsbruck, Austria; 6Bladon Associates Ltd., Oxford, UK; 7Incentive Partners ApS, Holte, Denmark; 8Department of Urology, Cambridge University Hospitals NHS Trust, Cambridge, UK Purpose: To estimate gains in health utility for two different catheter features and a support service related to urinary catheters used for intermittent catheterization. Patients and methods: Two internet-based time trade-off (TTO) surveys were undertaken to value vignettes describing two innovative catheter features and a support service. The first TTO survey “Size and Service” included catheters with compact design and the availability of a support service for users; the second TTO survey “Phthalates” included avoidance of potentially harmful phthalates in the material of the catheters. All participants were from the UK; they traded health states against a time horizon that matched their total life expectancy. Sensitivity analyses were done to estimate the impact of extreme values on disutilities. Results: The participants (n=890) estimated the incremental value of 0.031 (95% CI: 0.024–0.039), 0.009 (95% CI: 0.003–0.015), and 0.037 (95% CI: 0.027–0.046), respectively, for catheters with compact design, availability of support service, and catheters not containing phthalates. Conclusions: Participants valued all three improvements in catheter design. To capture the impact of such design improvements on quality of life and utilities, vignette-based approaches can be a useful supplement to the conventional, generic tools. Keywords: intermittent catheterization, time trade-off, vignette-based approach, health-related quality of life, QALY

Introduction: We investigated the association of bolus insulin dose timing with demographics, adherence, diabetes education program participation, experience with hypoglycemic events, glycemic control, and patient preference among respondents with type 2 diabetes.Methods: Adults with type 2 diabetes from 12 countries were recruited to a Web-based self-reported patient preference survey. Adherence was measured using an adapted Morisky Medication Adherence Scale questionnaire.Results: In total 1483 respondents reported using bolus insulin with 58% (n = 864) dosing bolus insulin before meals (pre-meal cohort), 354 (24%) during or after meals (post-meal cohort), and 265 (18%) before, during, or after meals (mixed cohort). The mixed cohort was excluded, thus 1218 respondents were included in the analysis. Respondent distribution across HbA(1c) category differed significantly depending on insulin dose timing (p = 0.0006); more respondents in the post-meal cohort (40%) had HbA(1c) >= 9% (74.9 mmol/mol) than in the pre-meal cohort (29%). The post-meal cohort was significantly more likely to report non-adherence than the pre-meal cohort (OR = 1.50, p = 0.01) and significantly more often reported participating in diabetes education programs (p Conclusions: Approximately 24% of respondents never comply with guidelines for insulin dose timing, with higher risk of non-adherence and increased participation in diabetes care programs. Respondents dosing insulin post-meal are more likely to have poor glycemic control (HbA(1c) >= 9%, 74.9 mmol/mol). Given that many respondents had high HbA(1c) and were non-adherent, a treatment which satisfies patient preference for bolus insulin with flexible dose timing could be considered.

The objective was to elicit patient preferences for medicine administration method in the management of acute agitation episodes among patients diagnosed with bipolar disorder or schizophrenia. The patients’ experiences of acute agitation episodes and their management of episodes were also explored. Data were collected via an anonymous, internet-based survey of residents in Denmark or Sweden with schizophrenia or bipolar disorder (October 2014 to December 2014). Inclusion criteria were having a diagnosis of schizophrenia or bipolar disorder, and being above 18 years of age. The questionnaire included questions about preferences for medication attributes, experiences with pharmacological treatment for agitation and involvement in treatment plans. A total of 237 diagnosed patients (61 with schizophrenia; 176 with bipolar disorder) completed the questionnaire. Agitation episodes were experienced by 90% of the respondents. In total, 83% of the respondents reported having received treatment with tablets. When patients were presented with the attributes of an inhalation method, respondents stated that the fast onset of action, low risk of adverse reactions and least invasive form of drug delivery were positive attributes of treatment with inhalation. Inhalation is a new delivery route for treatment of acute agitation in patients diagnosed with bipolar disorder or schizophrenia. Inhalation is the preferred treatment method for acute agitation among Danish and Swedish patients with bipolar disorder or schizophrenia.

Diabetes is associated with progression to severe COVID-19. The objective of this study was to estimate to what extent the increased risk among people with diabetes could impact the secondary care costs of COVID-19 throughout Europe during the first wave of the COVID-19 pandemic from January to June 2020. Applying a health care cost model based on inputs from data published in international peer-reviewed journals, identified via a rapid literature review this study aimed to estimate the total secondary sector costs of COVID-19. Estimates of unit costs were based on data from Denmark, France, Spain and the UK. We calculated average costs per patient without diabetes and according to four diabetes categories based on risk of hospitalization, admission to intensive care unit, ventilator support and length of hospital stay. The estimated cost per hospital admission during the first wave of COVID-19 in Europe ranged between EUR 25,018 among people with type 2 diabetes in good glycaemic control to EUR 57,244 among people with type 1 diabetes in poor glycaemic control, reflecting higher risk of intensive care, ventilator support and longer hospital stay according to diabetes category, while the corresponding cost for people without diabetes was estimated at EUR 16,993. The total direct costs of secondary care of COVID-19 in Europe were estimated at EUR 13.9 billion. Thus, 23.5% of the total costs accounted for treating people with diabetes. This study highlights the importance of a greater focus on prevention and adequate treatment of diabetes and the need for special attention to avoid infection with COVID-19 to the extent possible among those already diagnosed with diabetes.

Objective To examine the relationship between diabetes distress and gender, and the association with glycemic control, social support, health behaviors, and socio-economic status. Methods All adolescents, aged 15 to 18 years, in the national, pediatric diabetes registry SWEDIABKIDS with type 1 diabetes were invited to complete an online questionnaire. A total of 2112 teenagers were identified. Results 453 complete responses were valid for analyses. Young women scored significantly higher on the distress-screening instrument DDS-2. Almost half of the female respondents exhibited moderate to severe diabetes distress—more than twice the proportion than among male respondents (44% vs 19%). Females reported twice as high scores on the fear of hypoglycemia scale (P

Background The purpose of the survey was to assess the knowledge of family planning issues associated with disease modifying therapies (DMTs) among patients diagnosed with multiple sclerosis (MS). Methods 590 Danish MS patients responded to an online questionnaire about family planning in MS, collecting demographics, disease characteristics, disease modifying treatment, knowledge of potential teratogenic effects in DMTs, number of children, occurrence of unplanned pregnancies and outcome, and sources of information. Results 488 females and 102 males, mean age 40 years, responded. On average, it was 6.5 and 10.9 years since diagnosis and first symptoms, respectively. 16% of female and 19% of male respondents did not receive DMT at the time of responding to the survey. 30% of all had received only one DMT, 37%, 19%, 8%, and 5% had received two, three, four, and five different treatments, respectively. 42% of female and 74% of male respondents said they did not know if the medication they were taking had teratogenic risks. 83% of females and 85% of males responded that they did not know, whether DMT in male MS patients may expose healthy partners to teratogenic risks; hereto, 13% and 10%, respectively, answered that no transmission occurs. On average respondents had two children; three of four children reported in the study were born prior to the respondents being diagnosed with MS. 50% of both female and male respondents without children wanted a family and 25% of females and 16% of males wanted to start a family within the next two years. 91% of female respondents would discontinue DMT during pregnancy. Among male respondents 32% would continue treatment during a partner's pregnancy and 47% did not know whether they would continue or discontinue treatment. 10% of the female patients had had unplanned pregnancies during MS treatment, of these 49% chose to have an abortion. 53% of all felt they were well informed about MS treatment and family planning. 22% and 41% of the respondents received information from the neurologist about teratogenic risks in female MS patients and about teratogenic risks in women with male MS patients as partners, respectively; 27% and 34%% retrieved information from the internet on these two issues. Conclusion This survey uncovered a low level of knowledge about DMTs’ teratogenic risks among MS patients irrespective of sex. Knowledge about potential teratogenic risks for male MS patients receiving DMTs while planning to start a family was largely absent. 10% of female patients had experienced unplanned pregnancies on MS treatment. In general, patients use the internet and their neurologist to the same extent for information on parenthood planning.

ObjectiveThe aim of this study was to investigate the impact of hypoglycemia according to severity and time of onset on health-related quality of life (HRQoL) in a Canadian population.MethodsTime trade-off (TTO) methodology was used to estimate health utilities associated with hypoglycemic events in a representative sample of the Canadian population. A global analysis conducted in the United Kingdom, Canada, Germany and Sweden has been published. The present Canadian analysis focuses on 3 populations: general, type 1 and type 2 diabetes. Using a web-based survey, participants (>18 years) assessed the utility of 13 different health states (severe, non-severe, daytime and nocturnal hypoglycemia at different frequencies) using a scale from 1 (perfect health) to 0 (death). The average disutility value for each type of event was calculated.ResultsOf 2258 participants, 1696 completers were included in the analysis. A non-severe nocturnal hypoglycemic event was associated with a significantly greater disutility than a non-severe daytime event (−0.0076 vs. −0.0056, respectively; p=0.05), while there was no statistically significant difference between severe nocturnal and severe daytime events (−0.0616 vs. −0.0592; p=0.76). Severe hypoglycemia was associated with greater disutility than non-severe hypoglycemia (p

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.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.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.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.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.

To assess nurses' preferences for various attributes of chronic obstructive pulmonary disease (COPD) inhalation devices in order to obtain information about the relative importance of the different attributes and their assigned levels.Data from a web-based questionnaire among Danish nurses who treat patients with COPD (accomplished in the spring/summer of 2015) was used. A total of 222 nurses completed the questionnaire which was based on discrete choice experiment (DCE) methodology. The probability of choosing an alternative from a number of choices in a discrete choice game was estimated by means of the conditional logit model.The two most important attributes according to the COPD-treating nurses were "Indicator when empty" and "Inspiratory flow rate". In addition, the nurses considered the attribute "Obvious that dose is given" important. The three least-valued attributes were frequency of doses, whether the inhaler requires fine motor skills and whether it requires hand strength.Inhalation devices can be classified into five categories, where the soft mist inhaler (SMI) includes the three most important attributes among its characteristics.The study sample size does not allow for subgroup analysis, which would have been valuable. The questionnaire design gives an indication of nurses' preferences and it is assumed that these are similar to real life choices, but the current study cannot conclude on the nurses' actual choices.

Background Agitation episodes are common among patients with schizophrenia or bipolar disorder. Oral and intramuscular administration methods are commonly used in pharmacological treatment of acute agitation. Recently, an innovative inhalation product with loxapine(Adasuve®)has become available for treatment of acute agitation episodes associated with bipolar disorder or schizophrenia. The objective for the present study was to investigate the impact of the pharmacological treatment’s administration methods on the health-related quality of life (HRQoL) in patients with bipolar disorder or schizophrenia in Denmark and Sweden using a time trade-off (TTO) approach. Methods The TTO methodology was used to examine the HRQoL impact of administration method of pharmacological treatment of acute agitation. Data were collected via an internet-based survey, using an existing panel of respondents with schizophrenia or bipolar disorder. Results Respondents considered living with schizophrenia/ bipolar disorder, having one yearly agitation episode treated with inhaler better than living with the same conditions and receiving treatment with tablet or injection. The utility value was 0.762 for inhalable treatment, 0.707 for injection and 0.734 for tablet treatment. Conclusions Patients’ preference for treatment delivery options showed that inhalation was associated with a significant utility gain when compared to injection or tablets. Inhalable loxapine may be a new tool for control of agitation episodes for strengthening the patient provider alliance when taking patient’s preference for delivery method into consideration.

The purpose of this study was to investigate the preferences of people with diabetes for liraglutide vs other glucose lowering drugs, based on outcomes of clinical trials.Willingness to pay (WTP) for diabetes drug treatment was assessed by combining results from a recent WTP study with analysis of results from the Liraglutide Effect and Action in Diabetes (LEAD) programme. The LEAD programme included six randomised clinical trials with 3967 participants analysing efficacy and safety of liraglutide 1.2 mg (LEAD 1-6 trials), rosiglitazone (LEAD 1 trial), glimepiride (LEAD 2-3 trials), insulin glargine (LEAD 5 trial), and exenatide (LEAD 6 trial). The WTP survey used discrete choice experimental (DCE) methodology to evaluate the convenience and clinical effects of glucose lowering treatments.People with type 2 diabetes were prepared to pay an extra €2.64/day for liraglutide compared with rosiglitazone, an extra €1.94/day compared with glimepiride, an extra €3.36/day compared with insulin glargine, and an extra €0.81/day compared with exenatide. Weight loss was the largest component of WTP for liraglutide compared with rosiglitazone, glimepiride, and insulin glargine. Differences in the administration of the two drugs was the largest component of WTP for liraglutide (once daily anytime) compared with exenatide (twice daily with meals). A limitation of the study was that it was based on six clinical trials where liraglutide was the test drug, but each trial had a different comparator, therefore the clinical effects of liraglutide were much better documented than the comparators.WTP analyses of the clinical results from the LEAD programme suggested that participants with type 2 diabetes were willing to pay appreciably more for liraglutide than other glucose lowering treatments. This was driven by the relative advantage of weight loss compared with rosiglitazone, glimepiride, and insulin glargine, and administration frequency compared with exenatide.

Objectives: To study patient preferences for diabetes-treatment related attributes among people with type 2 diabetes. Research design and methods: Participants were recruited from three diabetes out-patient clinics and two general practitioner surgeries. Data were collected electronically and results were analysed using a standard statistical model designed for choice sets (conditional logit), Six characteristics relating to treatment of diabetes were examined: glycated haemoglobin level (HbA(1c)), weight (gain or loss), hypoglycaemic events, need for injections, transient nausea and need for blood glucose testing. Results: Two hundred and seventy participants with type 2 diabetes (178 males, 92 females) were included. Patients placed the most value on losing weight and were willing to pay the most to lose 6 kg of weight. Loss of 3 kg of weight was the next highly valued, followed by dropping one percentage point in HbA(1c) level. Avoidance of nausea and a reduction in hypogaycaemic events from two per month to none was also highly valued. Patients were willing to accept one injection per day if they, for instance, simultaneously lost 1.4 kg. A limitation of the study is that the survey was web-based and response rates for such surveys can be extremely variable. Conclusion: Patients with type 2 diabetes in Denmark were willing to pay for the health benefits associated with improved diabetes treatment the most important of these being weight loss or avoidance of weight gain, and reduction of HbA1c, and of hypoglycaemic events.

Objectives: To investigate response rates for online and paper versions of an identical questionnaire and the differences between respondents to each and between respondents and non-respondents among a population with type 2 diabetes. Methods: We mailed letters containing an invitation to complete an online questionnaire to 2045 individuals, followed by two reminders; the second included a paper version of the questionnaire. Results: In total, 1081 people responded to either version of the questionnaire, yielding a response rate of 54%. Compared to total respondents, respondents completing the online version were more likely to be male, better educated, and younger, and have had diabetes for a shorter period of time. Compared to non-respondents, respondents were more likely to be male and have a lower hemoglobin A1c level. Conclusion: Web-based surveys are capable of delivering a substantial number of responses cost-effectively. However, disadvantages related to selection bias should be taken into account, and mixed-mode methods should be considered when surveying populations with type 2 diabetes.

BACKGROUND Long-acting insulin treatments with varying clinical benefits are currently available for patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM). The current evidence base demonstrates the efficacy of treatments, but it is critical also to understand patient preferences regarding treatments and how they are determined. OBJECTIVE This study aimed to measure the willingness to pay (WTP) of individuals with diabetes in the United Kingdom for different attributes of long-acting insulin therapy. METHODS A survey based on discrete choice experiment methodology was developed to elicit the preferences and values of adults with T1DM or insulin-dependent T2DM regarding different aspects of their therapy. Participants were presented with a series of 27 paired choices and asked which they preferred. WTP values were calculated for relevant attribute levels. RESULTS A total of 252 participants completed the questionnaire (52% response rate); 143 had T1DM and 109 had insulin-treated T2DM. The highest WTP values in participants with T1DM were avoiding 2-kg or 4-kg weight gain (£29 and £58, respectively), avoiding major difficulties with the injection device (£49), increasing the number of days per week when blood glucose levels are in the target range from 2 to 6 (£40), reducing the number of daily injections from 3 to 1 (£39), and avoiding nighttime hypoglycemia (£33). In participants with T2DM, similar factors had the highest WTP. CONCLUSIONS This is the first study to assess WTP for long-acting insulin therapy and could have implications for future guidelines on diabetes management, however some limitations, notably in sample selection, could affect generalizability of the results. In both T1DM and T2DM, the highest WTP values were for avoidance of weight gain, and reduction in the number of injections and hypoglycemia.

Objectives: This study assessed patient preferences, using willingness to pay as a method to measure different treatment characteristics or attributes associated with injectable insulin therapy in patients with type 2 diabetes. Research design and methods: Adults with type 2 diabetes in 12 countries, diagnosed >6 months prior and receiving insulin for >3 months, were recruited through a representative online panel. Data were collected via online questionnaire and analyzed using a standard choice model for discrete choice experiment. Results: A total of 3758 patients from North America (n=646), South America (n=1537), and Europe (n=1575) completed the study. Mean glycated hemoglobin (HbA1c) levels in North America, South America, and Europe were 63 mmol/mol (7.9%), 75 mmol/mol (9.0%), and 64 mmol/mol (8.0%), respectively. In the three regions, monthly willingness to pay was US$116, US$74, and US$92, respectively, for a 1%-point decrease in HbA1c; US$99, US$80, and US$104 for one less major hypoglycemic event per year; and US$64, US$37 and US$60 for a 3 kg weight decrease. To avoid preinjection preparation of insulin, the respective values were US$47, US$18, and US$37, and US$25, US$25, and US$24 for one less injection per day. Among respondents on basal-only insulin who had previously tried a more intensive regimen, reasons for switching back included difficulty in handling multiple injections and risk of hypoglycemic events. Conclusions: Reducing HbA1c, frequency of major hypoglycemic events and weight decrease were the highest valued outcomes in each region. The administrative burden of injections was also considered important.

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. Electronic supplementary material The online version of this article (doi:10.1186/s12955-016-0411-0) contains supplementary material, which is available to authorized users.

Sustained treatment adherence, usually over long periods of time, is critical to the success of growth hormone (GH) therapy. However, adherence rates are often poor which may result in suboptimal clinical outcomes. The type of device used by patients to administer their GH can influence adherence. Offering patients a choice of device maximizes the chance of adherence to treatment. Multiple factors will influence a patient’s choice of device, depending on individual priorities. This study evaluated the most preferred features of GH injection devices by parents using a web-based questionnaire and as assessed by their willingness to pay for specific device features. The results show that parents are willing to pay for device features facilitating ease of use.

Stewart B Harris,1 Kamlesh Khunti,2 Mona Landin-Olsson,3 Claus B Galbo-Jørgensen,4 Mette Bøgelund,4 Barrie Chubb,5 Jens Gundgaard,6 Marc Evans71Schulich School of Medicine and Dentistry, Western University, London, ON, Canada; 2Diabetes Research Unit, University of Leicester, Leicester, UK; 3Department of Medicine, Helsingborg Hospital, Lund University, Lund, Sweden; 4Incentive, Holte Stationsvej, Holte, Denmark; 5EU Health Economics and Outcomes Research, Novo Nordisk Ltd, Crawley, UK; 6Health Economics and HTA, Novo Nordisk A/S, Søborg, Denmark; 7Department of Diabetes, University Hospital Llandough, Cardiff, UKAims: We sought to develop descriptions of health states associated with daytime and nocturnal hypoglycemia in a structured fashion from the patient's perspective under different combinations of severity and frequency of hypoglycemic events.Methods: An expert meeting followed by two patient focus groups was used to develop comprehensive descriptions of acute consequences of severe and non-severe, daytime and nocturnal hypoglycemia. Patients with diabetes (type 1 = 85, type 2 = 162) from a survey panel then validated these descriptions and assessed how often they worried and took different actions to prevent hypoglycemia. Severity and frequency of hypoglycemia were compared with respect to how often people worried and took actions to prevent an event. The effect of hypoglycemia on 35 different life activities was quantitatively compared for patients who had and had not experienced a severe hypoglycemic event.Results: At least 95% of respondents agreed that the detailed patient-level descriptions of health states accurately reflected their experience of severe and non-severe, daytime and nocturnal hypoglycemia, thereby validating these descriptions. Respondents who had experienced a severe hypoglycemic event were generally more adversely affected in their worries and actions and life events than those who experienced only non-severe events; those who experienced nocturnal events were more affected than those who experienced only daytime events.Conclusion: The negative psychosocial consequences and undesirable compensatory behaviors arising from hypoglycemia underscore the importance of preventing severe episodes, particularly severe nocturnal episodes. These validated descriptions for hypoglycemia from the patient's perspective may also help inform future qualitative and quantitative research.Keywords: hypoglycemia, health states, diabetes, quality of life

Objectives Decreased estrogen production due to menopause is often associated with vaginal atrophy, and estrogen therapy is the most effective treatment for the management of this condition. This study investigated women's preferences relating to various aspects of local estrogen therapy (LET) for the treatment of postmenopausal vaginal atrophy. Study design The study involved 423 women aged >50 years who were resident in Sweden, had experienced menopausal changes in and around the vagina, and had used LET for these changes. The women completed an online questionnaire. Main outcome measures The questionnaire involved a discrete choice experiment to determine women's willingness to pay for different characteristics of therapy. Time of LET appliance, use of disposable applicators with small tablets compared with both dosing syringes with vaginal cream and vagitories, and therapy that did/did not cause smudges/leakage were all considered. Results The women had no significant preference as to the time of day LET should be used. However, quantifying other preferences suggested that respondents were willing to pay €66.58 or €60.32 per month extra for using disposable applicators with small tablets rather than dosing syringes with vaginal cream or vagitories, respectively, and to avoid smudges/leakage. Conclusions This survey suggests that women may prefer using disposable applicators with small tablets to deliver LET and value therapy that does not cause smudges/leakage. It is possible that if women are able to use their preferred form of LET, improved uptake or adherence of such medication may enhance the management of postmenopausal vaginal atrophy.

Objective To determine preferences among patients with type 2 diabetes for content and format of patient education. Methods Using discrete choice methods, we surveyed patients about their preferences for patient education. We investigated preferred content and format regarding education on living well with diabetes, preventing complications, healthy eating, exercising, and psychosocial issues related to diabetes. Results We obtained usable responses from 2187 patients with type 2 diabetes. Acquiring competencies to live a fulfilling life with diabetes, adjust diet and exercise habits, and prevent complications was significantly more highly valued than was simply being informed about these topics. Patients preferred to be involved in the planning of their diabetes care and valued individually tailored content higher than prescheduled content. Women and younger patients found diet and exercise significantly more important than did men, and patients with poorly controlled diabetes valued all education and support more highly than did patients in better control. Conclusion Patients with type 2 diabetes prefer to be actively involved in educational activities, to develop competencies to prevent and manage complications, and to involve their social network in supporting them. Practice implications Future patient education should enhance participation and competence development and include relatives.

This study aimed to investigate the most important consequences of diabetes medication, as measured by the patients' willingness to pay (WTP).People in Sweden were recruited using existing nationwide e-mail panels if they were adults (or=18 years) with type 2 diabetes and were receiving pharmacological anti-diabetes treatment(s). Data were collected electronically and results were analysed using a standard statistical model designed for choice games (conditional logit). Six characteristics relating to treatment of diabetes were examined: weight (gain or loss), mean glycated haemoglobin level (HbA(1c)), hypoglycaemic events, nausea, need for injections (with or independently of meals), and blood glucose testing.A total of 461 people with type 2 diabetes (291 males; 170 females) completed an internet questionnaire and were eligible for inclusion. Participants placed high value on weight loss and nausea avoidance; they would pay 176 Swedish Krona (SEK)/euro15.61 per month to lose 1 kg, and would pay SEK 560 (euro49.67) per month to avoid nausea completely. Patients wanting to reduce the number of hypoglycaemic events from three per month to none were willing to pay SEK 419 (euro37.17) per month. Patients valued a 1 percentage point reduction in HbA(1c) at SEK 414 (euro36.72) per month. Participants preferred taking tablets to injections and required a compensation of SEK 376 (euro33.35) to accept one injection/day. Injections independent of meals were preferred to injections with meals (WTP: SEK 140/euro12.42 per month). Potential limitations of this study are that the preferences expressed may not match preferences in real-life situations, and bias through the use of electronic questionnaire, which restricted participation to those with access to, and experience with, the internet.People with type 2 diabetes were willing to pay a considerable amount of money each month to lose weight, reduce or avoid hypoglycaemic events and reduce HbA(1C).

Quantifying The Short-Term Impact of Changes In Hba1c, Weight And Insulin Regimen on Health Related Quality-of-Life

Investigating the short-term impact of poor glycemic control on the daily lives of people with type 2 diabetes

Background Hypoglycaemic events, particularly nocturnal, affect health-related quality of life (HRQoL) via acute symptoms, altered behaviour and fear of future events. We examined the respective disutility associated with a single event of daytime, nocturnal, severe and non-severe hypoglycaemia. Methods Representative samples were taken from Canada, Germany, Sweden, the United States and the United Kingdom. Individuals completed an internet-based questionnaire designed to quantify the HRQoL associated with different diabetes- and/or hypoglycaemia-related health states. HRQoL was measured on a utility scale: 1 (perfect health) to 0 (death) using the time trade-off method. Three populations were studied: 8286 respondents from the general population; 551 people with type 1 diabetes; and 1603 with type 2 diabetes. Respondents traded life expectancy for improved health states and evaluated the health states of well-controlled diabetes and diabetes with non-severe/severe and daytime/nocturnal hypoglycaemic events. Results In the general population, non-severe nocturnal hypoglycaemic events were associated with a 0.007 disutility compared with 0.004 for non-severe daytime episodes, equivalent to a significant 63% increase in negative impact. Severe daytime and nocturnal events were associated with a 0.057 and a 0.062 disutility, respectively, which were not significantly different. Conclusions This study applies an established health economic methodology to derive disutilities associated with hypoglycaemia stratified by onset time and severity using a large multinational population. It reveals substantial individual and cumulative detrimental effects of hypoglycaemic events – particularly nocturnal – on HRQoL, reinforcing the clinical imperative of avoiding hypoglycaemia.