Jutta Genz

Time-dependent impact of diabetes on mortality in patients after major lower extremity amputation: survival in a population-based 5-year cohort in Germany.

OBJECTIVE To estimate the impact of diabetes on mortality in patients after first major lower extremity amputation (LEA). RESEARCH DESIGN AND METHODS Using claims data of a nationwide statutory health insurance, we assessed all deaths in a cohort of all 444 patients with a first major LEA since 2005 (71.8% male; mean age 69.1 years; 58.3% diabetic; 43% with amputation above the knee) up to 2009. Using Cox regression, we estimated the time-dependent hazard ratios to compare patients with and without diabetes. RESULTS The cumulative 5-year mortality was 68% in diabetic and 59% in nondiabetic individuals. In the first course, mortality was lower in diabetic compared with nondiabetic patients. Later, the diabetes risk increased yielding crossed survival curves after 2 to 3 years (time dependency of diabetes; P = 0.003). Age- and sex-adjusted hazard ratios for diabetes were as follows: 0–30 days: 0.50 [95% CI 0.31–0.84]; 31–60 days: 0.60 [0.25–1.41]; 61 days to 6 months: 0.75 [0.38–1.48]; >6–12 months: 1.27 [0.63–2.53]; >12–24 months: 1.65 [0.88–3.08]; >24–36 months: 2.02 [0.80–5.09]; and >36–60 months: 1.91 [0.70–5.21]. The pattern was similar in both sexes. In the full model, significant risk factors for mortality were age (1.05; 1.03–1.06), amputation above the knee (1.50; 1.16–1.94), and quartile category 3 or 4 of the number of prescribed medications (1.64; 1.12–2.40 and 1.76; 1.20–2.59). Further adjustment for comorbidity did not alter the results. CONCLUSIONS In this population-based study, we found a time-dependent mortality risk of diabetes following first major LEA, which may be in part a result of a healthier lifestyle in diabetic patients or the access to specific treatment structures in diabetic individuals.

Reduced incidence of blindness in relation to diabetes mellitus in southern Germany

Diabet. Med. 27, 1138–1143 (2010)

Incidence of renal replacement therapy (RRT) in the diabetic compared with the non-diabetic population in a German region, 2002-08.

BACKGROUND This study was conducted to estimate incidences of renal replacement therapy (RRT) in the diabetic and non-diabetic populations in Germany, as well as relative and attributable risks of RRT due to diabetes. METHODS Using the data of a regional dialysis centre (region population of 310 000), we assessed all incident RRT patients aged 30 years or older in 2002-08. We estimated sex- and age-specific and -standardized incidences of RRT in the diabetic and non-diabetic populations, which were estimated by applying diabetes prevalences from a population-based study, and relative and attributable risks due to diabetes. RESULTS Of all subjects with incident RRT (n = 544), 49.6% had diabetes. Fifty-eight percent were male, mean age (SD) was 70.3 years (11.4 years). Incidences per 100 000 person-years (standardized to the 2004 German population) in the diabetic and the non-diabetic populations were 213.7 [95% confidence interval (95% CI), 159.5-267.8] and 26.9 (95% CI, 22.5-31.3) in men and 130.2 (95% CI, 65.6-194.9) and 16.4 (95% CI, 13.5-19.3) in women, respectively. Standardized relative risks were 7.9 (5.9-10.8) in men and 8.0 (4.7-13.5) in women. There was a significant interaction between age and diabetes, with lower relative risks in higher ages. Attributable risks among diabetic individuals were 0.87 in men and women, and population-attributable risks were 0.41 and 0.35 in men and women, respectively. CONCLUSIONS In this population-based study in a German region, we found the relative risk of RRT in the estimated adult diabetic population to be 8-fold increased compared with the non-diabetic population. A high proportion of the RRT risk can be attributed to diabetes in the diabetic as well as in the whole population.

Blood glucose testing and primary prevention of diabetes mellitus type 2 - evaluation of the effect of evidence based patient information

BackgroundEvidence-based patient information (EBPI) has been recognised as important tool for informed choice in particular in the matter of preventive options. An objective, on the best scientific evidence-based consumer information about subthreshold elevated blood glucose levels (impaired fasting glucose and impaired glucose tolerance) and primary prevention of diabetes, is not available yet. Thus we developed a web-based EBPI and aim to evaluate its effects on informed decision making in people 50 years or older.Methods/DesignWe conduct a web-based randomised-controlled trial to evaluate the effect of information about elevated blood glucose levels and diabetes primary prevention on five specific outcomes: (i) knowledge of elevated blood glucose level-related issues (primary outcome); (ii) attitudes to a metabolic testing; (iii) intention to undergo a metabolic testing; (iv) decision conflict; (v) satisfaction with the information. The intervention group receives a specially developed EBPI about subthreshold elevated blood glucose levels and diabetes primary prevention, the control group information about this topic, available in the internet.The study population consists of people between 50 and 69 years of age without known diabetes. Participants will be recruited via the internet page of the cooperating health insurance company, Techniker Krankenkasse (TK), and the internet page of the German Diabetes Centre. Outcomes will be measured through online questionnaires. We expect better informed participants in the intervention group.DiscussionThe design of this study may be a prototype for other web-based prevention information and their evaluation.Trial registrationCurrent Controlled Trial: ISRCTN22060616.

Studies analysing the need for health-related information in Germany - a systematic review

BackgroundExploring health-related information needs is necessary to better tailor information. However, there is a lack of systematic knowledge on how and in which groups information needs has been assessed, and which information needs have been identified. We aimed to assess the methodology of studies used to assess information needs, as well as the topics and extent of health-related information needs and associated factors in Germany.MethodsA systematic search was performed in Medline, Embase, Psycinfo, and all databases of the Cochrane Library. All studies investigating health-related information needs in patients, relatives, and the general population in Germany that were published between 2000 and 2012 in German or English were included. Descriptive content analysis was based on predefined categories.ResultsWe identified 19 studies. Most studies addressed cancer or rheumatic disease. Methods used were highly heterogeneous. Apart from common topics such as treatment, diagnosis, prevention and health promotion, etiology and prognosis, high interest ratings were also found in more specific topics such as complementary and alternative medicine or nutrition. Information needs were notable in all surveyed patient groups, relatives, and samples of the general population. Younger age, shorter duration of illness, poorer health status and higher anxiety and depression scores appeared to be associated with higher information needs.ConclusionKnowledge about information needs is still scarce. Assuming the importance of comprehensive information to enable people to participate in health-related decisions, further systematic research is required.

Blood glucose testing and primary prevention of Type 2 diabetes—evaluation of the effect of evidence‐based patient information: a randomized controlled trial

Diabet. Med. 29, 1011–1020 (2012)

Stroke in the diabetic and non-diabetic population in Germany: relative and attributable risks, 2005-2007.

BACKGROUND Reduction of cardiovascular events has been declared to be a main objective in diabetes care. Little is known about incidences of stroke in the diabetic compared to the non-diabetic population and its trend. We evaluated nationwide incidence of stroke in the diabetic compared to the non-diabetic populations as well as relative and attributable stroke risks due to diabetes in Germany. METHODS Using data of a statutory health insurance (1.6 million members in Germany), we assessed all first strokes in 2005-2007. We estimated sex/age-specific and standardised incidence of strokes in the diabetic and non-diabetic populations and relative and attributable risks due to diabetes. RESULTS A total of 6160 subjects had a first stroke [66.6% male, mean age (S.D.)=67.0 (13.9) years]; 31.4% had diabetes. Incidence per 100,000 person years (standard: 2004 German population) in the diabetic and non-diabetic populations, respectively, is as follows: men: 476 [95% confidence interval (CI)=438-514] and 255 (95% CI=243-266); women: 342 (95% CI=305-378) and 173 (95% CI=163-182). Age-standardised relative risks are as follows: 1.9 (95% CI=1.7-2.0) in men and 2.0 (95% CI=1.8-2.2) in women. The following are attributable risks among exposed: 0.46 (95% CI=0.41-0.51) in men and 0.49 (95% CI=0.43-0.55) in women; population attributable risks are as follows: 0.14 (95% CI=0.11-0.16) in men and 0.14 (95% CI=0.11-0.17) in women. CONCLUSIONS In this nationwide study, we found the stroke risk in the diabetic population to be still significantly increased compared to the non-diabetic population. The risk increase seems to be as high as earlier observations in other countries, despite large efforts to improve diabetes care.

Time-dependent impact of diabetes on the mortality of patients on renal replacement therapy: a population-based study in Germany (2002-2009).

AIMS To estimate the impact of diabetes on the mortality of patients with incident renal replacement therapy (RRT). METHODS We assessed the mortality of 544 incident RRT patients aged ≥ 30 years between 2002 and 2009 (57.9% men, mean age 70.3 years, 49.6% patients with diabetes) by analyzing the data of all dialysis centers covering a German region. We compared the estimated time-dependent hazard ratios of patients with and without diabetes by using the Cox proportional-hazards regression model. RESULTS Overall, 319 patients had died (158 diabetic), approximately 50% after 3 years. Up to about 3 years, the mortality rate was lower in diabetic than in nondiabetic patients. Thereafter, the survival curves crossed (interaction diabetes × time, p = 0.002; adjusted hazard ratios for diabetes: baseline, 0.66; year 1, 0.84; year 2, 1.05; year 3, 1.33; year 4, 1.68). The results were similar in men and women; however, the interaction of diabetes and time was significant only in men (p = 0.004). Further significant risk factors of mortality were age, sex, initial central venous catheter, cardiovascular disease, and malignancy. CONCLUSIONS In this population-based study, the influence of diabetes was time-dependent, with a lower mortality in diabetic versus non-diabetic patients in the first three years but a higher mortality in these patients after 3 years. Results were similar in men and women.

Socioeconomic factors and effect of evidence-based patient information about primary prevention of type 2 diabetes mellitus - are there interactions?

BackgroundHaving shown in a recent randomized controlled trial that evidence-based patient information (EBPI) significantly increased knowledge on primary prevention of diabetes compared to standard patient information, we now investigated interaction between socioeconomic status (SES) and the effect of an EBPI.Findings1,120 visitors (aged 40–70 years, without known diabetes) to the “Techniker Krankenkasse” and the “German Diabetes Center” websites were randomized. The intervention group received a newly developed on-line EBPI, the control group standard on-line information. The primary outcome measure was knowledge, classified as “good/average/poor”. We analyzed associations of knowledge with socioeconomic variables (education, vocational training, employment, subjective social status) combined with intervention effect including interactions, adjusted for possible confounding by knowledge before intervention, self–reported blood glucose measurements, blood pressure, blood lipid levels, age and gender. Logistic regression models were fitted to the subpopulation (n = 647) with complete values in these variables.Education (high vs. low) was significantly associated with knowledge (good vs. average/poor); however, there was no significant interaction between education and intervention. After adjustment, the other socioeconomic variables were not significantly associated with knowledge.ConclusionsSocioeconomic variables did not significantly change the effect of the intervention. There was a tendency towards a lower effect where lower educated individuals were concerned. Possibly the power was too low to detect interaction effects. Larger studies using SES-specific designs are needed to clarify the effect of SES. We suggest considering the socioeconomic status when evaluating a decision aid, e.g. an EBPI, to ensure its effectiveness not only in higher socioeconomic groups.Trial registrationCurrent Controlled Trials ISRCTN22060616 (Date assigned: 12 September 2008).

Assessment of information needs in diabetes: Development and evaluation of a questionnaire

AIM To develop a questionnaire suitable for assessing the information needs of individuals with diabetes mellitus types 1 and 2 in diverse healthcare settings (e.g. primary care or long-term care) and at different time points during the course of the disease. METHODS The initial questionnaire was developed on the basis of literature search and analysis, reviewed by clinical experts, and evaluated in two focus groups. The revised version was pilot-tested on 39 individuals with diabetes type 2, type 1 and gestational diabetes. RESULTS The final questionnaire reveals the most important information needs in diabetes. A choice task, a rating task and open-ended questions are combined. First, participants have to choose three topics that interest them out of a list with 12 general topics and specify in their own words their particular information needs for the chosen topics. They are then asked how informed they feel with regard to all topics (4-point Likert-scale), and whether information is currently desired (yes/no). The questionnaire ends with an open-ended question asking for additional topics of interest. CONCLUSIONS Careful selection of topics and inclusion of open-ended questions seem to be essential prerequisites for the unbiased assessment of information needs. The questionnaire can be applied in surveys in order to examine patterns of information needs across various groups and changes during the course of the disease. Such knowledge would contribute to more patient-guided information, counselling and support.