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.

[Research Data Center on Health - Vision for Further Development from the Research Perspective]. / Forschungsdatenzentrum Gesundheit ­ Vision für eine Weiterentwicklung aus Sicht der Forschung.

The German research data center for health will provide claims data of statutory health insurances. The data center was set up at the medical regulatory body BfArM pursuant to the German data transparency regulation (DaTraV). The data provided by the center will cover about 90% of the German population, supporting research on healthcare issues, including questions of care supply, demand and the (mis-)match of both. These data support the development of recommendations for evidence-based healthcare. The legal framework for the center (including §§ 303a-f of Book V of the Social Security Code and two subsequent ordinances) leaves a considerable degree of freedom when it comes to organisational and procedural aspects of the center's operation. The present paper addresses these degrees of freedom. From the point of view of researchers, ten statements show the potential of the data center and provide ideas for its further and sustainable development.

Assessment of patient-reported outcomes after polytrauma - instruments and methods: a systematic review.

OBJECTIVES: We (1) collected instruments that assess health-related quality of life (HRQoL), activities of daily living (ADL) and social participation during follow-up after polytrauma, (2) described their use and (3) investigated other relevant patient-reported outcomes (PROs) assessed in the studies. DESIGN: Systematic Review using the Preferred Reporting Items for Systematic Review and Meta-Analysis guideline. DATA SOURCES: MEDLINE, Embase, CINAHL, PsycINFO, CENTRAL, as well as the trials registers ClinicalTrials.gov and WHO ICTRP were searched from January 2005 to April 2018. ELIGIBILITY CRITERIA: All original empirical research published in English or German including PROs of patients aged 18-75 years with an Injury Severity Score≥16 and/or an Abbreviated Injury Scale≥3. Studies with defined injuries or diseases (e.g. low-energy injuries) and some text types (e.g. grey literature and books) were excluded. Systematic reviews and meta-analyses were excluded, but references screened for appropriate studies. DATA EXTRACTION AND SYNTHESIS: Data extraction, narrative content analysis and a critical appraisal (e.g. UK National Institute for Health and Care Excellence) were performed by two reviewers independently. RESULTS: The search yielded 3496 hits; 54 publications were included. Predominantly, HRQoL was assessed, with Short Form-36 Health Survey applied most frequently. ADL and (social) participation were rarely assessed. The methods most used were postal surveys and single assessments of PROs, with a follow-up period of one to one and a half years. Other relevant PRO areas reported were function, mental disorders and pain. CONCLUSIONS: There is a large variation in the assessment of PROs after polytrauma, impairing comparability of outcomes. First efforts to standardise the collection of PROs have been initiated, but require further harmonisation between central players. Additional knowledge on rarely reported PRO areas (e.g. (social) participation, social networks) may lead to their consideration in health services provision. PROSPERO REGISTRATION NUMBER: CRD42017060825.

Health Care Use and Costs in Individuals With Diabetes With and Without Comorbid Depression in Germany: Results of the Cross-sectional DiaDec Study.

OBJECTIVE: Increased health care use and costs have been reported in individuals with diabetes with comorbid depression. Knowledge regarding cost differences between individuals with diabetes alone and those with diabetes and diagnosed/undiagnosed depression is, however, scarce. We therefore compared use and costs for patients with diabetes and no depression and patients with diabetes and documented depression diagnosis or self-reported depression symptoms for several cost components, including mental health care costs. RESEARCH DESIGN AND METHODS: Data from a 2013 cross-sectional survey of randomly sampled members of a nationwide German statutory health insurance (SHI) provider with diabetes (n = 1,634) were linked individually with SHI data covering four quarters before and after the survey. Self-reported depression symptoms were assessed with the Patient Health Questionnaire-9, with depression diagnosis taken from SHI data. We analyzed health care use and costs, using regression analysis to calculate cost ratios (CRs) with adjustment for sociodemographic/socioeconomic factors and comorbidities for two groups: 1) those with no symptoms and no diagnosis and 2) those with symptoms or diagnosis. In our explorative subanalysis we analyzed subgroups with either symptoms or diagnosis separately. RESULTS: Annual mean total health care costs were higher for patients with comorbid depression (EUR 5,629 [95% CI 4,987-6,407]) than without (EUR 3,252 [2,976-3,675], the CR being 1.25 [1.14-1.36]). Regression analysis showed that excess costs were highly associated with comorbidities. Mental health care costs were very low for patients without depression (psychotherapy EUR 2; antidepressants EUR 4) and still relatively low for those with depression (psychotherapy EUR 111; antidepressants EUR 76). CONCLUSIONS: Costs were significantly higher when comorbid depression was present either as symptoms or diagnosed. Excess costs for mental health services were rather low.

New prescription of antihyperglycemic agents among patients with diabetes in Germany: Moderate concordance between health insurance data and self-reports.

PURPOSE: To analyze the concordance of new prescription of antihyperglycemic agents between two data sources: patients' self-reports and statutory health insurance (SHI) data among patients with diabetes. METHODS: Within a cross-sectional study, 494 patients with diabetes were interviewed if and which new prescriptions of diabetes medication they received within the last 3 or 6 months. SHI data for 12 months were linked to cover these periods. For the agreement measurement, SHI data was set as reference, and kappa, positive predictive value (PPV), and sensitivity were calculated for single Anatomical Therapeutic Chemical (ATC) codes and cumulated code groups. RESULTS: The number of new prescriptions within 3 or 6 months was low, with 5.5% (n = 27) for Metformin/self-report being the highest. Contingency tables were unbalanced and showed large numbers in the no/no-cells. Regarding non-agreement, we found new prescriptions slightly more often in SHI data only than in self-reports only, with insulin and metformin representing an exception. Agreement results were moderate with large confidence intervals (CI). The values for cumulated "all drugs in diabetes" were: kappa = 0.58 (95% CI: 0.51-0.65), PPV = 62.0 (53.4-70.2), sensitivity = 55.6 (47.3-63.6). CONCLUSIONS: Patients reported a low number of new prescriptions within the last 3 or 6 months. In general we found moderate agreement and in case of non-agreement that self-report no/SHI yes was slightly more frequent than vice versa. These results were based on small case numbers, but could nevertheless be considered when collecting self-reported information on the prescription of antihyperglycemic agents.

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.

Assessment of patient-reported outcomes after polytrauma: protocol for a systematic review.

INTRODUCTION: Survivors of polytrauma experience long-term and short-term burden that influences their lives. The patients' view of relevant short-term and long-term outcomes should be captured in instruments that measure quality of life and other patient-reported outcomes (PROs) after a polytrauma. The aim of this systematic review is to (1) collect instruments that assess PROs (quality of life, social participation and activities of daily living) during follow-up after polytrauma, (2) describe the instruments' application (eg, duration of period of follow-up) and (3) investigate other relevant PROs that are also assessed in the included studies (pain, depression, anxiety and cognitive function). METHODS AND ANALYSIS: The systematic review protocol is developed in line with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols statement. MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Cochrane Central Register of Controlled Trials and the trials registers ClinicalTrials.gov and WHO International Clinical Trials Registry Platform will be searched. Keywords, for example, 'polytrauma', 'multiple trauma', 'quality of life', 'activities of daily living' or 'pain' will be used. Publications published between January 2005 and the most recent date (currently: August 2016) will be included. In order to present the latest possible results, an update of the search is conducted before publication. The data extraction and a content analysis will be carried out systematically. A critical appraisal will be performed. ETHICS AND DISSEMINATION: Formal ethical approval is not required as primary data will not be collected. The results will be published in a peer-reviewed publication. PROSPERO REGISTRATION NUMBER: CRD42017060825.

Agreement found between self-reported and health insurance data on physician visits comparing different recall lengths.

OBJECTIVE: To analyze the impact of different recall lengths on agreement between self-reported physician visits and those documented in health insurance data applying an experimental design. STUDY DESIGN AND SETTING: We randomly assigned 432 patients with diabetes to one of two versions of a written survey, each asking about the number of physician visits over a 3- or 6-month recall period. Health insurance data were linked individually. RESULTS: In both groups, the mean number of self-reported physician visits per month was lower than in the insurance data, with a larger difference in the 6-month group (-0.9; 95% CI -1.0, -0.7) than in the 3-month group (-0.5; -0.7; -0.2), difference between the two groups: 0.4 (0.1-0.7; P = 0.009). The percentage of participants with correct reporting was small and did not differ largely between the two groups (6.5% and 9.3%). However, there was more overreporting in the 3-month group (25.6% vs. 11.1%). CONCLUSIONS: Shorter recall periods may produce more accurate results when estimating the mean number of physician visits. However, this may be driven not by a more accurate reporting, but by a higher proportion of respondents that overreported and a lower proportion of respondents that underreported, when compared to the longer reporting period.

Personal attributes that influence the adequate management of hypertension and dyslipidemia in patients with type 2 diabetes. Results from the DIAB-CORE Cooperation.

BACKGROUND: Hypertension and dyslipidemia are often insufficiently controlled in persons with type 2 diabetes (T2D) in Germany. In the current study we evaluated individual characteristics that are assumed to influence the adequate treatment and control of hypertension and dyslipidemia and aimed to identify the patient group with the most urgent need for improved health care. METHODS: The analysis was based on the DIAB-CORE project in which cross-sectional data from five regional population-based studies and one nationwide German study, conducted between 1997 and 2006, were pooled. We compared the frequencies of socio-economic and lifestyle factors along with comorbidities in hypertensive participants with or without the blood pressure target of<140/90 mmHg. Similar studies were also performed in participants with dyslipidemia with and without the target of total cholesterol/HDL cholesterol ratio<5. Furthermore, we compared participants who received antihypertensive/lipid lowering treatment with those who were untreated. Univariable and multivariable logistic regression models were used to assess the odds of potentially influential factors. RESULTS: We included 1287 participants with T2D of whom n=1048 had hypertension and n=636 had dyslipidemia. Uncontrolled blood pressure was associated with male sex, low body mass index (BMI), no history of myocardial infarction (MI) and study site. Uncontrolled blood lipid levels were associated with male sex, no history of MI and study site. The odds of receiving no pharmacotherapy for hypertension were significantly greater in men, younger participants, those with BMI<30 kg/m(2) and those without previous MI or stroke. Participants with dyslipidemia received lipid lowering medication less frequently if they were male and had not previously had an MI. The more recent studies HNR and CARLA had the greatest numbers of well controlled and treated participants. CONCLUSION: In the DIAB-CORE study, the patient group with the greatest odds of uncontrolled co-morbidities and no pharmacotherapy was more likely comprised of younger men with low BMI and no history of cardiovascular disease.