Impact of disease progression on health-related quality of life of advanced ovarian cancer patients - Pooled analysis from the PRIMA trial.

OBJECTIVE: Progression-free survival (PFS) is an important early efficacy endpoint in ovarian cancer (OC) and its relevance to patients should be assessed. PRIMA, a phase III trial, assessed niraparib in patients with OC; this post hoc analysis examined the relationship between disease progression in OC and health-related quality of life (HRQoL). METHODS: The PRIMA trial randomized patients with advanced OC responsive to first-line platinum-based chemotherapy to once daily maintenance oral niraparib or placebo. This post hoc analysis evaluated the impact of disease progression on HRQoL by comparing HRQoL at the last visit pre-progression to end of treatment (EoT), and after 4, 8, 12, and 24 weeks. Assessments included the Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI), the European Quality of Life Five Dimension Five Level questionnaire (EQ-5D-5L) and EQ Visual Analogue Scale (EQ-VAS), the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC-QLQ-C30), and the EORTC Quality of Life Questionnaire Ovarian Cancer module (EORTC-QLQ-OV28). RESULTS: This post hoc analysis included 733 patients. Mean FOSI, EQ-5D-5L, and EQ-VAS scores deteriorated from last visit pre-progression to EoT and remained low up to 24-week follow-up. Least squares mean changes from last visit pre-progression to EoT were -2.1 (95% confidence interval -2.4, -1.7) for FOSI, -4.6 (-5.6, -3.5) for the EQ-5D-5L index, and -7.9 (-9.6, -6.3) for EQ-VAS. CONCLUSIONS: Disease progression negatively impacted HRQoL in patients with OC. PFS is clinically relevant, and prolonging PFS may preserve HRQoL.

Costs of Public Health Screening of Children for Presymptomatic Type 1 Diabetes in Bavaria, Germany.

OBJECTIVE: We sought to evaluate costs associated with public health screening for presymptomatic type 1 diabetes in 90,632 children as part of the Fr1da study in Bavaria and in forecasts for standard care. RESEARCH DESIGN AND METHODS: We report on resource use and direct costs for screening-related procedures in the Fr1da study coordination center and laboratory and in participating pediatric practices and local diabetes clinics. Data were obtained from Fr1da study documents, an online survey among pediatricians, and interviews and records of Fr1da staff members. Data were analyzed with tree models that mimic procedures during the screening process. Cost estimates are presented as they were observed in the Fr1da study and as they can be expected in standard care for various scenarios. RESULTS: The costs per child screened in the Fr1da study were €28.17 (95% CI 19.96; 39.63) and the costs per child diagnosed with presymptomatic type 1 diabetes were €9,117 (6,460; 12,827). Assuming a prevalence of presymptomatic type 1 diabetes of 0.31%, as in the Fr1da study, the estimated costs in standard care in Germany would be €21.73 (16.76; 28.19) per screened child and €7,035 (5,426; 9,124) per diagnosed child. Of the projected screening costs, €12.25 would be the costs in the medical practice, €9.34 for coordination and laboratory, and €0.14 for local diabetes clinics. CONCLUSIONS: This study provides information for the planning and implementation of screening tests for presymptomatic type 1 diabetes in the general public and for the analysis of the cost-effectiveness of targeted prevention strategies.

Simulation Modeling for the Economic Evaluation of Population-Based Dietary Policies: A Systematic Scoping Review.

Simulation modeling can be useful to estimate the long-term health and economic impacts of population-based dietary policies. We conducted a systematic scoping review following the PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) guideline to map and critically appraise economic evaluations of population-based dietary policies using simulation models. We searched Medline, Embase, and EconLit for studies published in English after 2005. Modeling studies were mapped based on model type, dietary policy, and nutritional target, and modeled risk factor-outcome pathways were analyzed. We included 56 studies comprising 136 model applications evaluating dietary policies in 21 countries. The policies most often assessed were reformulation (34/136), taxation (27/136), and labeling (20/136); the most common targets were salt/sodium (60/136), sugar-sweetened beverages (31/136), and fruit and vegetables (15/136). Model types included Markov-type (35/56), microsimulation (11/56), and comparative risk assessment (7/56) models. Overall, the key diet-related risk factors and health outcomes were modeled, but only 1 study included overall diet quality as a risk factor. Information about validation was only reported in 19 of 56 studies and few studies (14/56) analyzed the equity impacts of policies. Commonly included cost components were health sector (52/56) and public sector implementation costs (35/56), as opposed to private sector (18/56), lost productivity (11/56), and informal care costs (3/56). Most dietary policies (103/136) were evaluated as cost-saving independent of the applied costing perspective. An analysis of the main limitations reported by authors revealed that model validity, uncertainty of dietary effect estimates, and long-term intervention assumptions necessitate a careful interpretation of results. In conclusion, simulation modeling is widely applied in the economic evaluation of population-based dietary policies but rarely takes dietary complexity and the equity dimensions of policies into account. To increase relevance for policymakers and support diet-related disease prevention, economic effects beyond the health sector should be considered, and transparent conduct and reporting of model validation should be improved.

Utility Decrements Associated With Diabetes and Related Complications: Estimates From a Population-Based Study in Germany.

OBJECTIVES: Health utility decrement estimates for diabetes and complications are needed for parametrization of simulation models that aim to assess the cost-utility of diabetes prevention and care strategies. This study estimates health utility decrements associated with diabetes and cardiovascular and microvascular complications from a population-based German study. METHODS: Data were obtained from the population based cross-sectional KORA (Cooperative Health Research in the Augsburg Region) health questionnaire 2016 and comprised n = 1072 individuals with type 2 diabetes and n = 7879 individuals without diabetes. Health utility was assessed through the EQ-5D-5L. We used linear regression models with interaction terms between type 2 diabetes and different cardiovascular and microvascular complications while adjusting for demographic and socio-economic factors and other comorbidities. RESULTS: Type 2 diabetes (ß = -0.028, standard error [SE] = 0.014), stroke (ß = -0.070, SE = 0.010), cardiac arrhythmia (ß = -0.031, SE = 0.006), heart failure (ß = -0.073, SE = 0.009), coronary heart disease (ß = -0.028, SE = 0.010), myocardial infarction (ß = -0.020, SE = 0.011, estimates of main effect), and neuropathy (ß = -0.067, SE = 0.020), diabetic foot (ß = -0.042, SE = 0.030), nephropathy (ß = -0.032, SE = 0.025), and blindness (ß = -0.094, SE = 0.056, estimates of interaction terms) were negatively associated with health utility. The interaction term for diabetes x stroke (ß = -0.052, SE = 0.021) showed that the utility decrement for stroke is significantly larger in people with type 2 diabetes than in people without diabetes. CONCLUSIONS: Diabetes, cardiovascular, and microvascular conditions are associated with significant health utility decrements. Utility decrements for some conditions differ between people with and without type 2 diabetes. These results are of high relevance for the parametrization of decision analytic simulation models and applied health economic evaluations in the field of prevention and management of type 2 diabetes in Germany.

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.

Association between unrealistic comparative optimism and self-management in individuals with type 2 diabetes: Results from a cross-sectional, population-based study.

BACKGROUND AND AIMS: Unrealistic comparative optimism (UO), as the erroneous judgement of personal risks to be lower than the risks of others, could help explain differences in diabetes self-management. The present study tested the hypothesis that individuals with type 2 diabetes who underestimate their comparative heart attack risk, have a lower adherence regarding recommended self-management. METHODS: We used data from individuals with type 2 diabetes participating in the German KORA (Cooperative Health Research in the Region of Augsburg) GEFU 4 (self-administered health questionnaire 2016) study. UO was estimated by comparing participants' subjective comparative risk for having a heart attack within the next 5-years (ie, "higher than others," "average," "lower than others"), with their objective comparative 10-year cardiovascular disease risk based on the Framingham equations. We estimated binary logistic and linear regression models to analyze which characteristics were associated with UO and to test the association between UO and participants' self-management behaviors (ie, regular self-monitoring of body weight, blood sugar, and blood pressure, regular foot care, keeping a diabetes diary, and having a diet plan), and their sum score, respectively. All models were adjusted for socio-demographic and disease-related variables. RESULTS: The studied sample included n = 633 individuals with type 2 diabetes (mean age 70.7 years, 45% women). Smokers and males were more likely to show UO than nonsmokers and females. Furthermore, a higher blood pressure and a higher body mass index were associated with a higher likelihood of UO regarding heart attack risk. However, UO was not significantly associated with patient self-management. CONCLUSIONS: Unfavorable health behavior and risk factors are associated with UO. However, our results suggest that UO with regard to perceived heart attack risk may not be a relevant factor for patient self-management in those with type 2 diabetes.

Associations between self-management behavior and sociodemographic and disease-related characteristics in elderly people with type 2 diabetes - New results from the population-based KORA studies in Germany.

AIMS: Self-management behavior (SMB) is an important aspect in the management of diabetes. This study aimed to identify sociodemographic and disease-related factors associated with good SMB in people with type 2 diabetes (T2D). METHODS: We used data from 479 people with T2D aged 65 or older from the population-based KORA (Cooperative Health Research in the Area of Augsburg) Health Survey 2016 in Southern Germany. We estimated Poisson and logistic regression models testing the cross-sectional relationship between individual or disease-related characteristics and an established SMB sum index comprising six SMB dimensions stratified according to insulin treatment status. RESULTS: Mean age in the sample was 75 and mean diabetes duration was 13 years. The overall level of SMB was low. Higher SMB index scores were associated with higher age, treatment with insulin, participation in a diabetes education program, and, for people with insulin treatment, with a BMI below 30 kg/m2. Single item analyses generally supported these findings. CONCLUSIONS: SMB in people with T2D needs to be improved with efficient interventions. Targeting obese individuals and those at an early stage of the disease with low-barrier, regular education or self-management programs may be a preferred strategy.

Change in Physical Activity after Diagnosis of Diabetes or Hypertension: Results from an Observational Population-Based Cohort Study.

Background: Chronic diseases like diabetes mellitus or hypertension are a major public health challenge. Irregular physical activity (PA) is one of the most important modifiable risk factors for chronic conditions and their complications. However, engaging in regular PA is a challenge for many individuals. The literature suggests that a diagnosis of a disease might serve as a promising point in time to change health behavior. This study investigates whether a diagnosis of diabetes or hypertension is associated with changes in PA. Methods: Analyses are based on 4261 participants of the population-based KORA S4 study (1999-2001) and its subsequent 7-and 14-year follow-ups. Information on PA and incident diagnoses of diabetes or hypertension was assessed via standardized interviews. Change in PA was regressed upon diagnosis with diabetes or hypertension, using logistic regression models. Models were stratified into active and inactive individuals at baseline to avoid ceiling and floor effects or regression to the mean. Results: Active participants at baseline showed higher odds (OR = 2.16 [1.20;3.89]) for becoming inactive after a diabetes diagnosis than those without a diabetes diagnosis. No other significant association was observed. Discussion: As PA is important for the management of diabetes or hypertension, ways to increase or maintain PA levels in newly-diagnosed patients are important. Communication strategies might be crucial, and practitioners and health insurance companies could play a key role in raising awareness.

Status quo bias and health behavior: findings from a cross-sectional study.

BACKGROUND: Status quo bias (SQB) has often been referred to as an important tool for improving public health. However, very few studies were able to link SQB with health behavior. METHODS: Analysis were based on data from the population-based KORA S4 study (1999-2001, n = 2309). We operationalized SQB through two questions. The first asked whether participants switched their health insurance for financial benefits since this was enabled in 1996. Those who did were assigned a 'very low SQB' (n = 213). Participants who did not switch were asked a second hypothetical question regarding switching costs. We assigned 'low SQB' to those who indicated low switching costs (n = 1035), 'high SQB' to those who indicated high switching costs (n = 588), and 'very high SQB' to those who indicated infinite switching costs (n = 473). We tested the association between SQB and physical activity, diet, smoking, alcohol consumption, the sum of health behaviors, and body mass index (BMI) using logistic, Poisson and ordinary least square regression models, respectively. Models were adjusted for age, sex, education, income, satisfaction with current health insurance and morbidity. RESULTS: SQB was associated with a higher rate of physical inactivity [OR = 1.22, 95% CI (1.11; 1.35)], a higher sum of unhealthy lifestyle factors [IRR = 1.05, 95% CI (1.01; 1.10)] and a higher BMI [ß = 0.30, 95% CI (0.08; 0.51)]. CONCLUSION: A high SQB was associated with unfavorable health behavior and higher BMI. Targeting SQB might be a promising strategy for promoting healthy behavior.

Time preference, outcome expectancy, and self-management in patients with type 2 diabetes.

BACKGROUND: Patient self-management is crucial to prevent complications and mortality in type 2 diabetes. From an economic perspective, time preference predicts short-sighted decision making and thus might help to explain non-adherence to self-anagement recommendations. However, recent studies on this association have shown mixed results. PURPOSE: In this study, we tested whether the combination of time preference and outcome expectancy can improve the predictions of self-management behavior. PATIENTS AND METHODS: Data from 665 patients with type 2 diabetes were obtained from the cross-sectional KORA (Cooperative Health Research in the Region of Augsburg) GEFU 4 study. Time preference and outcome expectancy were measured by one question each, which were answered on a 4-point Likert scale. Their association with six self-managing behaviors was tested in logistic and linear regression analyses. Likewise, we examined the association between self-management and the interaction of outcome expectancy and time preference. RESULTS: A high time preference was associated with a significantly lower sum of self-management behaviors (ß=-0.29, 95% CI [-0.54, -0.04]). Higher outcome expectancy was associated with a higher self-management score (ß=0.21, 95% CI [-0.03, 0.45]). The interaction model showed that low time preference was only associated with better self-management when combined with a high outcome expectancy (ß=0.05, 95% CI [-0.28, 0.39] vs ß=0.27, 95% CI [-0.09, 0.63]). CONCLUSION: Time preference and outcome expectancy are interrelated predictors of patient self-management and could be used to identify and to intervene on patients with a potentially poor self-management.

Direct healthcare costs associated with device assessed and self-reported physical activity: results from a cross-sectional population-based study.

BACKGROUND: Physical inactivity (PIA) is an important risk factor for many chronic conditions and therefore might increase healthcare utilization and costs. This study aimed to analyze the association of PIA using device assessed and self-reported physical activity (PA) data with direct healthcare costs. METHODS: Cross-sectional data was retrieved from the population based KORA FF4 study (Cooperative Health Research in the Region of Augsburg) that was conducted in southern Germany from 2013 to 2014 (n = 2279). Self-reported PA was assessed with two questions regarding sports related PA in summer and winter and categorized into "high activity", "moderate activity", "low activity" and "no activity". In a subsample (n = 477), PA was assessed with accelerometers and participants were categorized into activity quartiles ("very high", "high", "low" and "very low") according to their mean minutes per day spent in light intensity, or in moderate-vigorous PA (MVPA). Self-reported healthcare utilization was used to estimate direct healthcare costs. We regressed direct healthcare costs on PA using a two-part gamma regression, adjusted for age, sex and socio-demographic variables. Additional models, including and excluding potential additional confounders and effect mediators were used to check the robustness of the results. RESULTS: Annual direct healthcare costs of individuals who reported no sports PA did not differ from those who reported high sports PA [+€189, 95% CI: -188, 598]. In the subsample with accelerometer data, participants with very low MVPA had significantly higher annual costs than participants with very high MVPA [+€986, 95% CI: 15, 1982]. CONCLUSION: Device assessed but not self-reported PIA was associated with higher direct healthcare costs. The magnitude and significance of the association depended on the choice of covariates in the regression models. Larger studies with device assessed PA and longitudinal design are needed to be able to better quantify the impact of PIA on direct healthcare costs.

Applying the health action process approach to bicycle helmet use and evaluating a social marketing campaign.

BACKGROUND: Bicycle injuries are of concern in Canada. Since helmet use was mandated in 1996 in the province of British Columbia, Canada, use has increased and head injuries have decreased. Despite the law, many cyclists do not wear a helmet. Health action process approach (HAPA) model explains intention and behaviour with self-efficacy, risk perception, outcome expectancies and planning constructs. The present study examines the impact of a social marketing campaign on HAPA constructs in the context of bicycle helmet use. METHOD: A questionnaire was administered to identify factors determining helmet use. Intention to obey the law, and perceived risk of being caught if not obeying the law were included as additional constructs. Path analysis was used to extract the strongest influences on intention and behaviour. The social marketing campaign was evaluated through t-test comparisons after propensity score matching and generalised linear modelling (GLM) were applied to adjust for the same covariates. RESULTS: 400 cyclists aged 25-54 years completed the questionnaire. Self-efficacy and Intention were most predictive of intention to wear a helmet, which, moderated by planning, strongly predicted behaviour. Perceived risk and outcome expectancies had no significant impact on intention. GLM showed that exposure to the campaign was significantly associated with higher values in self-efficacy, intention and bicycle helmet use. CONCLUSION: Self-efficacy and planning are important points of action for promoting helmet use. Social marketing campaigns that remind people of appropriate preventive action have an impact on behaviour.

Costs and health-related quality of life in Alpha-1-Antitrypsin Deficient COPD patients.

BACKGROUND: Alpha-1-Antitrypsin Deficiency (AATD) is an economically unexplored genetic disease. METHODS: Direct and indirect costs (based on self-reported information on healthcare utilization) and health-related quality of life (HRQL, as assessed by SGRQ, CAT, and EQ-5D-3 L) were compared between 131 AATD patients (106 with, 25 without augmentation therapy (AT)) and 2,049 COPD patients without AATD participating in the COSYCONET COPD cohort. The medication costs of AT were excluded from all analyses to reveal differences associated with morbidity profiles. The association of AATD (with/without AT) with costs or HRQL was examined using generalized linear regression modelling (GLM) adjusting for age, sex, GOLD grade, BMI, smoking status, education and comorbidities. RESULTS: Adjusted mean direct annual costs were €6,099 in AATD patients without AT, €7,117 in AATD patients with AT (excluding costs for AT), and €7,460 in COPD patients without AATD. AATD with AT was significantly associated with higher outpatient (+273%) but lower inpatient (-35%) and medication costs (-10%, disregarding AT) compared with COPD patients without AATD. There were no significant differences between groups regarding indirect costs and HRQL. CONCLUSION: Apart from AT costs, AATD patients tended to have lower, though not significant, overall costs and similar HRQL compared to COPD patients without AATD. AT was not associated with lower costs or higher HRQL. TRIAL REGISTRATION: NCT01245933.