Risk and time preferences in individuals with lifestyle-related and non-lifestyle-related cardiovascular diseases: a pilot study.

OBJECTIVES: To (1) pilot a study of behavioural characterisation based on risk and time preferences in clinically well-characterised individuals, (2) assess the distribution of preferences in this population and (3) explore differences in preferences between individuals with 'lifestyle-related' (LS) and 'non-lifestyle-related' (NLS) cardiovascular diseases. DESIGN: Cross-sectional study with an economic online experiment to collect risk and time preferences, a detailed clinical characterisation and a sociodemographic and lifestyle survey. A definition of LS and NLS groups was developed. SETTING: Specialist outpatient clinics of the clinic for cardiology and pneumology of the University Hospital Düsseldorf and patients from a cardiology practice in Düsseldorf. PARTICIPANTS: A total of 74 individuals with cardiovascular diseases. OUTCOMES: Risk and time preferences. RESULTS: The implementation of the study process, including participant recruitment and data collection, ran smoothly. The medical checklist, the survey and the time preference instrument were well received. However, the conceptual understanding of the risk preference instrument resulted in inconsistent choices for many participants (47%). The remaining individuals were more risk averse (27%) than risk seeking (16%) and risk neutral (10%). Individuals in our sample were also more impatient (49%) than patient (42%). The participant classification showed that 65% belonged to the LS group, 19% to the NLS group and 16% could not be assigned (unclear allocation to lifestyle (ULS) group). Excluding the ULS group, we show that individuals in the LS group were more risk seeking, and unexpectedly, more patient than those in the NLS group. CONCLUSIONS: The process of the pilot study and its results can be used as a basis for the design of the main study. The differences in risk and time preferences between the LS and NLS groups provide us with a novel hypothesis for unhealthy behaviours: individuals never give up a bad habit, they simply postpone the latter, which can be tested alongside other additional research questions.

Prospective health care costs and lost work days associated with diabetes-related distress and depression symptoms among 1488 individuals with diabetes.

The aim of this study was to investigating the impact of major depression symptoms and diabetes-related distress on future health care costs and lost workdays in individuals with diabetes. We linked survey data from a random sample of a German statutory health insurance (SHI) with diabetes (n = 1488, 63.0% male, mean age 66.9 years) with their SHI data one year after the survey. Within the survey data we identified major depression symptoms (Patient Health Questionnaire-9) and diabetes-related distress (Problem Areas in Diabetes Scale). We retrieved health care costs and lost workdays from SHI data. To assess the impact of major depression symptoms and diabetes-related distress on health care costs and lost workdays, we adjusted regression models for age, sex, education, employment status, and diabetes duration, type, and severity. Major depression symptoms were associated with significantly higher costs (by a factor of 1.49; 95% CI: 1.18-1.88). Lost workdays were also more likely for respondents with depression symptoms (RR1.34; 0.97-1.86). Health care costs (by a factor of 0.81; 0.66-1.01) and the risk of lost workdays (RR 0.86; 0.62-1.18) may be lower among respondents with high diabetes-related distress. While major depression and diabetes-related distress have overlapping indicators, our results indicate different impacts on health care costs.

The value of loss of protective pain sensation in predicting a first ulceration of the foot in people with diabetes.

AIM: To determine both the risk of first ever ulcer (FEU) and its time to onset in a population which had loss of protective sensation (LOPS) in the foot either with or without loss of protective pain (LOPP). METHODS: People with diabetes and LOPS without history of FEU presenting in a specialist clinic were included. LOPP was diagnosed by reduced vibration perception and pain perception by using a pinprick simulator. Participants were followed by routine foot checks, phone interview or by letter until the occurrence of a FEU, death or the end of observation period. Survival functions in LOPP strata were compared by log rank test. The hazard ratio (HR) of an FEU in people with compared to people without LOPP was estimated using Cox regression. Time to first ulcer was estimated using the framework of an accelerated failure time (AFT) model. RESULTS: One hundred and thirty participants were followed up for a median of 48.3 months. Pain perception was lost in 55.4%. Eighteen people with LOPP developed a FEU (25.0%) as opposed to six (10.3%) of those with no LOPP (p = 0.02). Age-sex-adjusted HR for FEU was 3.0 (p = 0.02) for people with compared to people without LOPP. Age-sex-adjusted time to FEU for people with LOPP was approximately half (p = 0.03) than people without LOPP. CONCLUSIONS: It is suggested that estimation of LOPP is included in routine practice because of its high predictive value for a FEU.

Preferences of women in difficult life situations for a physical activity programme: protocol of a discrete choice experiment in the German NU-BIG project.

INTRODUCTION: The BIG project ('Bewegung als Investition in die Gesundheit', ie, 'Movement as Investment in Health') was developed in 2005 as a community-based participatory research programme to offer accessible opportunities for physical activity to women in difficult life situations. Since then, the programme has been expanded to eight sites in Germany. A systematic evaluation of BIG is currently being conducted. As part of this effort, we strive to understand the preferences of participating women for different aspects of the programme, and to analyse their willingness to pay. METHODS AND ANALYSIS: In this protocol, we describe the development and analysis plan of a discrete choice experiment (DCE) to investigate participants' preferences for a physical activity programme for women in difficult life situations. The experiment will be embedded in a questionnaire covering several aspects of participation in the programme (eg, reach, efficacy and further effects) and the socioeconomic characteristics of all active participants. After a thorough search of the literature, BIG documents review and expert interviews, we identified five important attributes of the programme: course times, travel time to the course venue, additional social activities organised by BIG, consideration of wishes and interests for the further planning of courses and costs per course unit. Thereafter, we piloted the experiment with a sample of participants from the target group. After data collection, the experiment will be analysed using a conditional logit model and a latent class analysis to assess eventual heterogeneity in preferences. ETHICS AND DISSEMINATION: Understanding women's preferences will provide useful insights for the further development of the programme and ultimately increase participation and retention. The questionnaire, the included DCE and the pretest on participants received ethical approval (application no. 20-247_1-B). We plan to disseminate the results of the DCE in peer-reviewed journals, national conferences and among participants and programme coordinators and organisers.

PHQ-9, CES-D, health insurance data-who is identified with depression? A Population-based study in persons with diabetes.

AIMS: Several instruments are used to identify depression among patients with diabetes and have been compared for their test criteria, but, not for the overlaps and differences, for example, in the sociodemographic and clinical characteristics of the individuals identified with different instruments. METHODS: We conducted a cross-sectional survey among a random sample of a statutory health insurance (SHI) (n = 1,579) with diabetes and linked it with longitudinal SHI data. Depression symptoms were identified using either the Centre for Epidemiological Studies Depression (CES-D) scale or the Patient Health Questionnaire-9 (PHQ-9), and a depressive disorder was identified with a diagnosis in SHI data, resulting in 8 possible groups. Groups were compared using a multinomial logistic model. RESULTS: In total 33·0% of our analysis sample were identified with depression by at least one method. 5·0% were identified with depression by all methods. Multinomial logistic analysis showed that identification through SHI data only compared to the group with no depression was associated with gender (women). Identification through at least SHI data was associated with taking antidepressants and previous depression. Health related quality of life, especially the mental summary score was associated with depression but not when identified through SHI data only. CONCLUSION: The methods overlapped less than expected. We did not find a clear pattern between methods used and characteristics of individuals identified. However, we found first indications that the choice of method is related to specific underlying characteristics in the identified population. These findings need to be confirmed by further studies with larger study samples.

Self-care time and rating of health state in persons with diabetes: results from the population-based KORA survey in Germany.

BACKGROUND: The amount of empirical research on whether people in fact include health-related changes in leisure time into health state valuations is limited and the results are inconclusive. In this exploratory study, we analyse whether time aspects of diabetes self-care might explain the ratings of the health state (HSR) in addition to the effects of physical and mental health-related quality of life. METHODS: Using the data from participants with diagnosed type 2 diabetes in the population-based KORA FF4 study (n = 190, 60% Male, mean age 69 ± 10 years), multiple logistic regression models were fitted to explain HSR (good vs. poor) in terms of the SF-12 physical and mental component summary (PCS and MCS) scores, time spent on diabetes self-care and a number of background variables. RESULTS: There was no significant association between time spent on diabetes self-care and HSR in models without interaction. Significant interaction term was found between the SF-12 PCS score and time spent on self-care. In models with interaction self-care time has a small, but significant impact on the HSR. In particular, for a PCS score under 40, more time increases the chance to rate the health state as "good", while for a PCS score above 40 there is a reverse effect. CONCLUSIONS: The additional impact of self-care time on HSR in our sample is small and seems to interact with physical health-related quality of life. More research is needed on whether inclusion of health-related leisure time changes in the denominator of cost-effectiveness analysis is sufficient.

Diabetes-related research priorities of people with type 1 and type 2 diabetes: a cross-sectional study in Germany.

To investigate (i) the importance and priorities of research objectives for people with type 1 (T1DM) and type 2 diabetes (T2DM); (ii) subgroups with specific research priorities; (iii) associated factors (e.g., sociodemographic characteristics) of the subgroups. The cross-sectional survey was conducted in 2018 using data from 869 respondents (29.0% response, 31.2% female, mean age 61.3 years, 62.7% T2DM) from a German statutory health insurance population. Diabetes-related research priorities were assessed with a questionnaire. Subgroups and associated factors were identified using latent class analysis. Three subgroups were found in T1DM: (1) high priority for the research topic 'healing diabetes' and moderate priority for the research topic 'prevention of long-term complications', (2) priorities for simplifying handling (high) and stress reduction (moderate), (3) priorities for healing diabetes (high) and simplifying handling (high). Three subgroups were found in T2DM: (1) priorities for simplifying handling (moderate), diabetes prevention (moderate) and prevention of long-term complications (moderate), (2) priorities for stress reduction (high) and diabetes prevention (moderate), (3) priorities for simplifying handling (high) and stress reduction (high). Classes differed in age and HbA1c. Knowledge about research priorities enables researchers to align their work with the needs of people with diabetes.

Different information needs in subgroups of people with diabetes mellitus: a latent class analysis.

BACKGROUND: Current evidence suggests that the information needs of people with diabetes mellitus differ across patient groups. With a view to being able to provide individualized information, this study aims to identify (i) the diabetes-related information needs of people with diabetes mellitus; (ii) different subgroups of people with specific information needs; and (iii) associated characteristics of the identified subgroups, such as sociodemographic characteristics, diabetes-related comorbidities, and well-being. METHODS: This cross-sectional study was based on data from 837 respondents with diabetes mellitus who participated in the population-based KORA (Cooperative Health Research in the Augsburg Region) Health Survey 2016 in Southern Germany (KORA GEFU 4 study) (45.6% female, mean age 71.1 years, 92.8% Type 2 diabetes). Diabetes-related information needs were assessed with a questionnaire asking about patients' information needs concerning 11 diabetes-related topics, e.g. 'long-term complications' and 'treatment/therapy'. Subgroups of people with different information needs and associated characteristics were identified using latent class analysis. RESULTS: We identified the following four classes of people with different information needs: 'high needs on all topics', 'low needs on all topics', 'moderate needs with a focus on complications and diabetes in everyday life', and 'advanced needs with a focus on social and legal aspects and diabetes research'. The classes differed significantly in age, years of education, type of diabetes, diabetes duration, diabetes-related comorbidities, smoking behaviour, diabetes education, current level of information, and time preference. CONCLUSIONS: Knowledge about different patient subgroups can be useful for tailored information campaigns or physician-patient interactions. Further research is needed to analyse health care needs in these groups, changes in information needs over the course of the disease, and prospective health outcomes.

Preferences of people with type 2 diabetes for telemedical lifestyle programmes in Germany: protocol of a discrete choice experiment.

INTRODUCTION: Telemedical lifestyle programmes for people with type 2 diabetes mellitus (T2DM) provide an opportunity to develop a healthier lifestyle and consequently to improve health outcomes. When implementing new programmes into standard care, considering patients' preferences may increase the success of the participants. This study aims to examine the preferences of people with T2DM with respect to telemedical lifestyle programmes, to analyse whether these preferences predict programme success and to explore the changes that may occur during a telemedical lifestyle intervention. METHODS AND ANALYSIS: We outline the protocol of the development and assessment of a discrete choice experiment (DCE) to examine patient preferences in a telemedical lifestyle programme with regard to the functions of the online portal, communication, responsibilities, group activities and time requirements. To develop the design of the DCE, we conducted pilot work involving healthcare experts and in particular people with T2DM using cognitive pretesting. The final DCE is being implemented within a randomised controlled trial for investigating whether participation in a telemedical lifestyle intervention programme sustainably improves the HbA1c values in 850 members of a large German statutory health insurance with T2DM. Preferences are being assessed before and after participants complete the programme. The DCE data will be analysed using regression and latent class analyses. ETHICS AND DISSEMINATION: The DCE study has been approved by the ethics committee of the medical faculty of the Heinrich Heine University Duesseldorf, registration number 2018-242-ProspDEuA, registered on 6 December 2018. The TeLIPro trial is registered at the US National Library of Medicine, registration number NCT03675919, registered on 15 September 2018. We aim to disseminate our results in peer-reviewed journals, at national and international conferences and among interested patient groups and the public.

Using statutory health insurance data to evaluate non-response in a cross-sectional study on depression among patients with diabetes in Germany.

BACKGROUND: Low response rates do not indicate poor representativeness of study populations if non-response occurs completely at random. A non-response analysis can help to investigate whether non-response is a potential source for bias within a study. METHODS: A cross-sectional survey among a random sample of a health insurance population with diabetes (n = 3642, 58.9% male, mean age 65.7 years), assessing depression in diabetes, was conducted in 2013 in Germany. Health insurance data were available for responders and non-responders to assess non-response bias. The response rate was 51.1%. Odds ratios (ORs) for responses to the survey were calculated using logistic regression taking into consideration the depression diagnosis as well as age, sex, antihyperglycaemic medication, medication utilization, hospital admission and other comorbidities (from health insurance data). RESULTS: Responders and non-responders did not differ in the depression diagnosis [OR 0.99, confidence interval (CI) 0.82-1.2]. Regardless of age and sex, treatment with insulin only (OR 1.73, CI 1.36-2.21), treatment with oral antihyperglycaemic drugs (OAD) only (OR 1.77, CI 1.49-2.09), treatment with both insulin and OAD (OR 1.91, CI 1.51-2.43) and higher general medication utilization (1.29, 1.10-1.51) were associated with responding to the survey. CONCLUSION: We found differences in age, sex, diabetes treatment and medication utilization between responders and non-responders, which might bias the results. However, responders and non-responders did not differ in their depression status, which is the focus of the DiaDec study. Our analysis may serve as an example for conducting non-response analyses using health insurance data.

Healthcare provision, functional ability and quality of life after proximal femoral fracture - 'ProFem': Study protocol of a population-based, prospective study based on individually linked survey and statutory health insurance data.

INTRODUCTION: Proximal femoral fractures (PFF) are among the most frequent fractures in older people. However, the situation of people with a PFF after hospital discharge is poorly understood. Our aim is to (1) analyse healthcare provision, (2) examine clinical and patient-reported outcomes (PROs), (3) describe clinical and sociodemographic predictors of these and (4) develop an algorithm to identify subgroups with poor outcomes and a potential need for more intensive healthcare. METHODS AND ANALYSIS: This is a population-based prospective study based on individually linked survey and statutory health insurance (SHI) data. All people aged minimum 60 years who have been continuously insured with the AOK Rheinland/Hamburg and experience a PFF within 1 year will be consecutively included (SHI data analysis). Additionally, 700 people selected randomly from the study population will be consecutively invited to participate in the survey. Questionnaire data will be collected in the participants' private surroundings at 3, 6 and 12 months after hospital discharge. If the insured person considers themselves to be only partially or not at all able to take part in the survey, a proxy person will be interviewed where possible. SHI variables include healthcare provision, healthcare costs and clinical outcomes. Questionnaire variables include information on PROs, lifestyle characteristics and socioeconomic status. We will use multiple regression models to estimate healthcare processes and outcomes including mortality and cost, investigate predictors, perform non-responder analysis and develop an algorithm to identify vulnerable subgroups. ETHICS AND DISSEMINATION: The study was approved by the ethics committee of the Faculty of Medicine, Heinrich-Heine-University Düsseldorf (approval reference 6128R). All participants including proxies providing written and informed consent can withdraw from the study at any time. The study findings will be disseminated through scientific journals and public information. TRIAL REGISTRATION NUMBER: DRKS00012554.

German Diabetes Study - Baseline data of retinal layer thickness measured by SD-OCT in early diabetes mellitus.

PURPOSE: Recent studies highlighted that early diabetic neurodegeneration is present before microvascular changes are visible. Retinal neurodegeneration can decrease retinal layer thickness. We aimed to determine whether decreased retinal layer thickness is present already in the early time course of disease. METHODS: A cross-sectional analysis of patients and healthy adults from the German Diabetes Study (GDS, ClinicalTrials.gov Identifier number: CT01055093, https://clinicaltrials.gov/ct2/show/NCT01055093). Inclusion criteria were a diagnosis of diabetes mellitus (DM) within the last 12 months. Retinal layers thickness in the nasal pericentral segment was measured by spectral domain ocular coherence tomography (SD-OCT). For statistical analysis proc mixed (sas-version 9.4) was used. RESULTS: One hundred and seventy-eight eyes of 89 patients with type 1 DM (58 males, age 36 ± 11 years, BMI 25.5 ± 4.2 kg/m²) and 242 eyes of 121 patients with type 2 DM (84 males, age 53 ± 10 years, BMI 31.9 ± 6.3 kg/m²) with a disease duration of less than 1 year were compared to 76 eyes of 38 controls (27 males, age 41 ± 16 years, BMI 27.3 ± 6.4 kg/m²). Analysis of retinal layer thickness and visual function did not reveal a significant difference between patients and controls. CONCLUSION: In the early course of DM potential, neurodegeneration does not relate to measureable changes of retinal layer thickness.

Severe hypoglycemia and diabetic ketoacidosis in young persons with preschool onset of type 1 diabetes mellitus: An analysis of three nationwide population-based surveys.

OBJECTIVES: To describe incidence rates and temporal trends of severe hypoglycemia (SH) and of hospitalizations for SH or diabetic ketoacidosis (DKA) in persons with early-onset, long-term type 1 diabetes (T1D) and associations of these short-term complications with potential risk factors. METHODS: This study includes data of 1,875 persons 11.2 to 21.9 years of age with early-onset (<5 years) and long-term (>10 years) T1D from 3 cross-sectional nationwide, population-based surveys conducted in 2009/2010, 2012/2013 and 2015/2016 using standardized questionnaires. Negative binomial regression was used to estimate incidence rates per 100 person-years (py), temporal trends and associations between potential risk factors and outcomes. RESULTS: The crude incidence rate of SH showed a decreasing trend over time (P for trend = .004), disappearing after adjustment for confounders (P for trend = .341). In contrast, adjusted rates of SH- and DKA-associated hospitalizations did not change significantly between 2009 and 2016 (P for trend = .306 and .774, respectively). Associations between sex, diabetes duration, insulin treatment regimen, hypoglycemia awareness as well as physical activity and SH were found, while family structure was associated with hospitalizations for SH. Family structure, socioeconomic status (SES), diabetes duration, and hemoglobin A1c values showed associations with DKA-related hospitalizations. CONCLUSIONS: After adjustment, rates of SH and SH- or DKA-associated hospitalization showed no significant changes in recent years. Structured education programs focusing on high-risk groups as, for example, persons with T1D living with 1 biological parent and the parents' partner or those with a low SES, should be implemented to reduce incidence rates of hospitalizations.

The intermediates take it all: asymptotics of higher criticism statistics and a powerful alternative based on equal local levels.

The higher criticism (HC) statistic, which can be seen as a normalized version of the famous Kolmogorov-Smirnov statistic, has a long history, dating back to the mid seventies. Originally, HC statistics were used in connection with goodness of fit (GOF) tests but they recently gained some attention in the context of testing the global null hypothesis in high dimensional data. The continuing interest for HC seems to be inspired by a series of nice asymptotic properties related to this statistic. For example, unlike Kolmogorov-Smirnov tests, GOF tests based on the HC statistic are known to be asymptotically sensitive in the moderate tails, hence it is favorably applied for detecting the presence of signals in sparse mixture models. However, some questions around the asymptotic behavior of the HC statistic are still open. We focus on two of them, namely, why a specific intermediate range is crucial for GOF tests based on the HC statistic and why the convergence of the HC distribution to the limiting one is extremely slow. Moreover, the inconsistency in the asymptotic and finite behavior of the HC statistic prompts us to provide a new HC test that has better finite properties than the original HC test while showing the same asymptotics. This test is motivated by the asymptotic behavior of the so-called local levels related to the original HC test. By means of numerical calculations and simulations we show that the new HC test is typically more powerful than the original HC test in normal mixture models.