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Evidence-based information is a prerequisite for informed choice. We compared the effect of evidence-based information on colorectal cancer screening with standard information in a randomised controlled trial. The primary endpoint was informed choice. We randomised 1,577 people insured by a large German statutory health insurance scheme, the Gmünder Ersatzkasse (GEK). The evidence-based information significantly increased informed choices: 44.0% vs. 12.8%; (difference 31.2%, 99% CI 25.7-36.7%; P0.001).

So far there has been no consensus on the criteria which confirm the validity of scientific contributions in conventional medicine (CM) and complementary/ alternative medicine (CAM). An interdisciplinary group of experts from various disciplines within each of the areas of medicine held six well-documented sessions in an effort to reach a consensus. The group agreed that the methods to confirm the validity of clinical trials are identical in CM and CAM. There are differences in research strategies and there may also be differences in interpreting the results, depending on the concept of medicine.

The article elucidates consideration of scientific criteria for the development and design of evidence-based patient information (EBPI). Immunotherapy of multiple sclerosis serves as an example. Since in EBPI lack of evidence or ambiguities in available evidence are explicitly communicated, processing of EBPI does not necessarily lead to certainty about benefit and harms of medical interventions. However, only if the information is comprehensive in this respect can the EBPI be regarded as a robust basis for an informed choice. EBPI requires substantial developmental efforts. Regarding the growing number of medical interventions and the half-life of information, the question of responsibility for provision of EBPI is crucial. A vision is drafted in which EBPI is driven by demand of the patients and the public and is provided according to a costs-by-cause principle by those who distribute usual information hitherto. Trained patient advocates can appraise quality of information by use of instruments that consider criteria of EBPI. Critical health literacy should evolve early in school and can later on enhance usefulness of EBPI for people concerned with health issues.

Graduated compression stockings (GCS) can effectively reduce postoperative deep vein thrombosis (DVT) and their use is recommended by expert committees. However, it appears that GCS are not frequently used. The objectives of this study are to evaluate the customary use of GCS in surgical settings in the City of Hamburg, Germany, and to present evidence on the effectiveness of GCS.A questionnaire on the use of thromboprophylaxis was sent to 48 surgeons in Hamburg. In addition, a comprehensive search for randomized-controlled trials, reviews, and meta-analyses indexed in MEDLINE (1984-06/2002) and the Cochrane Library (Issue 2, 2002) was conducted to show the effectiveness of GCS compared to nontreatment, other antithrombotic methods, or combined treatment.Of 48 surgeons 39 responded. Seven surgeons dismissed the use of GCS for thromboprophylaxis, 3 used GCS alone, 25 GCS in combination with heparin, and 4 used GCS only for patients at high risk. The review of the literature revealed the effectiveness of GCS in general and for abdominal surgical patients. Enhanced benefit is suggested when combining GCS with another intervention such as low-dose unfractionated heparin. Single application of GCS in orthopedic surgical or neurosurgical patients using venography showed no effect when compared to combined treatment of GCS and low molecular weight heparin. Trials with patients undergoing gynecological and urological surgeries are rare. There is a lack of trials investigating health-related quality of life and costs associated with the use of GCS. Complications are poorly reported. A determination as to the appropriate length of stockings is presently not possible.GCS should be integral part of DVT prophylaxis in surgical departments. Their ineffectiveness is likely in some surgical populations.

Information about mammography-screening as a basis for informed-decision making has to be evidence-based and presented in an unbiased format. This includes communication of results about effectiveness/lack of effectiveness of screening programmes (breast cancer mortality, total mortality), the quality of mammography as a screening test (sensitivity, specificity, positive and negative predictive values), and possible harm (consequences of false positive and false negative results, overdiagnosis of breast cancer, overtreatment). Outcome data have to be communicated as natural frequencies rather than relative differences. In order to avoid framing of data equal emphasis has to be put on the proportion of persons who are likely to benefit and those who are unlikely to benefit or likely to be harmed.

A total of 17 consumer brochures that deal with the screening for colorectal cancer were analysed by two independently working researchers. The aim was to assess the quality of the information as a basis for evidence-based informed decision making using pre-defined evaluation criteria. No brochures fulfilled the necessary criteria. In most brochures there was a lack of transparency of the information process. No data was provided for estimating individual risks of colorectal cancer morbidity or mortality. With respect to the efficacy of screening no data was provided about relative or absolute risk reductions, number needed to screen, number needed to harm, predictive rates and false positive rates. In conclusion, presently available information brochures in Germany do not allow informed decision-making by consumers.

This article presents the evidence of mammography-screening for communication between the physician and the consumer. Scientific data on the quality of mammography as a screening test (sensitivity, specificity, positive and negative predictive values), effectiveness of screening programs (breast cancer mortality, total mortality), and possible harm (consequences of false positive and false negative results, overdiagnosis of breast cancer, radiation) are presented. Outcome data are communicated as absolute numbers rather than relative differences. In order to avoid framing of data equal emphasis is put on the proportion of persons who are likely to benefit and those who are unlikely to benefit or likely to be harmed.

The diabetic foot syndrome has a strong impact on the morbidity of elderly patients with type 2 diabetes, since diabetics have a 22-fold higher amputation rate. The aim of this study was to conduct a prospective evaluation of elderly insulin-treated patients with type 2 diabetes, giving special consideration to the diabetic foot syndrome. 94 consecutively admitted patients (mean age 68 years; mean diabetes duration 13 years) were re-evaluated 2, 5 and 10 years after participation in a 5-day insulin treatment and teaching programme for patients with type 2 diabetes. During the 10-year follow-up period 60 (64%) patients had died. Of the remaining 34 patients 33 were evaluated personally or by phone. All patients still alive had no acute foot complications and no amputations during the 10-year follow-up period. In these patients an acceptable level of metabolic control and acute metabolic decompensations was found. However, in 55 deceased patients (no data were available for 5 patients) 20 above-knee amputations (1 patient on both legs) and 2 fore-foot amputations were performed. This shows that severe complications as amputations associated with high mortality will be grossly underestimated, unless deceased patients are included in follow-up studies. An improved care for the feet of elderly insulin-treated patients is needed.

Before any treatment of type 2 diabetes in accordance with the principles of evidence-based medicine can be generally recommended, the considerable disease heterogeneity must be taken into account, and randomized controlled intervention trials directed to cardiovascular and microangiopathic organ damage end points must be performed for the various subgroups of patients. Until then, it appears prudent to treat the typical Caucasian type 2 diabetic patient primarily by nondrug therapies, and if they fail to achieve the patient's individual treatment goals, then insulin treatment should be initiated. Treatment of type 2 diabetic patients with insulin alone, aimed at the patient's individual therapeutic goals, is effective and safe when conducted as an integral part of specific and structured treatment and teaching programs. Insulin treatment can be safely used to achieve near-normal HbA1c levels (7.0-7.5%) if prevention of diabetic microangiopathy is indicated, or to maintain HbA1c levels8.5-9.0% if catabolic symptoms due to insulin deficiency are to be prevented.

This contribution describes the nationwide implementation of an intensive treatment and education program for type 1 diabetic patients in the clinical routine of the German health care system. Based on the formation of a working group (Arbeitsgemeinschaft Strukturierte Diabetestherapie [ASD]) of presently 57 general internal medicine departments, mainly from secondary and tertiary care levels in city and country hospitals throughout the country, a peer-review quality circle was formed as an official working group of the German Diabetes Association. The participating institutions performed a structured program of intensive treatment and education in all type 1 diabetic patients referred to them on a routine basis. The program includes multiple daily insulin injections or continuous subcutaneous insulin infusion, several times daily blood glucose self-monitoring and self-adaptation of insulin dosages and other aspects of treatment by the patients, and a far-reaching liberalization of the nutrition regimen. The group has attempted to document and to improve the quality of the structure and process of type 1 diabetes care in its participating institutions by a system of peer supervision. Furthermore, all member institutions volunteered to collect outcome data based on systematic 1-1.3 years' follow-up examinations of consecutive type 1 diabetic patients. For the 1997 evaluation of 1,103 type 1 diabetic patients, significant decreases of GHb levels and of incidence rates of severe hypoglycemia (from 0.35 to 0.16 cases per patient-year) and ketoacidosis (from 0.08 to 0.02 cases per patient-year) are presented. The ASD quality circle represents a model to improve principal aspects of type 1 diabetes care on a nationwide basis.

The objective of the present study was to analyse the association between cigarette smoking and progression of retinopathy and nephropathy, respectively, in a prospective multicentre study including 636 people with Type 1 diabetes: 81% of the original cohort of consecutively referred patients, aged 15 to 40 years and free of severe late diabetic complications. At baseline, all patients had participated in a 5-day in-patient group treatment and teaching programme for intensification of insulin therapy. Patients were examined at recruitment, and after 1, 2, 3 and 6 years including assessment of smoking status, blood pressure, metabolic control, and degree of nephropathy. Degree of retinopathy was assessed by ophthalmoscopy or fundus photography at baseline and after 6 years. Several logistic regression analyses were performed by describing the responses retinopathy and nephropathy, respectively, either as progression yes/no or as actual status at the 6-year follow-up and by using different measures for smoking. Adjustments for important covariables were made. While significant associations between smoking, and retinopathy and nephropathy respectively, were found, the relations were variable depending on the statistical model used. The results show that the real associations between smoking and retinopathy and nephropathy are complex and that more emphasis should be put on the complete description of the response variables and the statistical models used in clinical and epidemiological research.

Despite the availability of multiple nonpharmacological and pharmacological antihypertensive regimens large scale control of BP on a population basis is still unsatisfactory. To achieve a better quality in hypertension care we have developed and evaluated a structured outpatient hypertension treatment and teaching programme. This programme aims at improving of patients' compliance to antihypertensive therapy and is based on four groups sessions mainly conducted by paramedical personnel. This programme was evaluated in three different settings: in patients with hypertension, diabetes mellitus and poor compliance to antihypertensive drug therapy; in blind patients with diabetic nephropathy and severe hypertension; and in patients with essential hypertension as treated by primary healthcare physicians in general practice. In all three studies a significant improvement in compliance to antihypertensive therapy and, hence, in BP control was demonstrated leading to preservation of renal function in diabetic nephropathy and fewer drug prescriptions in essential hypertension. In conclusion, studies evaluating the effect of large scale implementation of such structured treatment and teaching programmes on the quality of hypertension care in the community should be carried out.

We investigated the accuracy of blood glucose self monitoring in 131 patients (mean +/- SD age 65 +/- 7 years, duration of diabetes 11 +/- 6 years) who participated in a 5-day inpatient group treatment and teaching programme especially designed for elderly insulin-treated patients. Patients' estimations and laboratory blood glucose measurements were compared on day 1 (after theoretical and practical introduction into blood glucose self monitoring) and on day 4 of the programme. Patients were trained in the visual reading of Haemoglukotest 20-800R; blood glucose meters were recommended only exceptionally. Error grid analysis showed a high accuracy of visually assessed blood glucose values, both on day 1 (94% of measurements in zone A, 5% in zone B) and on day 4 (95% in zone A, 4% in zone B). Patients with no prior experience in blood glucose self monitoring (n = 67) showed a significant improvement (p less than 0.02) in accuracy from day 1 to day 4. Values determined by blood glucose meters were less accurate, although this trend did not reach statistical significance. A second group of 94 consecutive patients was reexamined 5 years after participation in the treatment and teaching programme. 55 patients were still alive and 42 could be evaluated. Accuracy of blood glucose estimations was assessed in all 26 patients practising blood glucose self monitoring (age 69 +/- 5 years, diabetes duration 18 +/- 8 years), either at their homes (n = 23) or at our diabetes outpatient clinic (n = 3). Error grid analysis showed a high accuracy by visual reading (n = 21, 95% zone A, 5% zone B).(ABSTRACT TRUNCATED AT 250 WORDS)

Durch die Einfuhrung der Methoden zur Blutzuckerselbstkontrolle ist es Patienten mit Typ-I-Diabetes prinzipiell moglich geworden, unter ambulanten Bedingungen die Blutzuckerwerte zu normalisieren. Erste eindrucksvolle Behandlungserfolge wurden mit schwangeren Diabetikerinnen erzielt. So zeigten Jovanovic et al. [1], das wahrend der gesamten Schwangerschaft mittlere Blutzuckerwerte von etwa 90 mg% ohne erhohtes Risiko schwerer Unterzuckerungen erreichbar sind. Durch Normoglykamie wahrend der Schwangerschaft lassen sich fetale Makrosomie und assoziierte Komplikationen vermeiden [1, 2]. Normoglykamie bereits vor der Konzeption und wahrend der Schwangerschaft reduziert die Hyperglykamie-assoziierte Misbildungsrate bei Kindern diabetischer Mutter [2].

Ein pathologisches Verhalten der Thrombozyten wird seit langem als moglicher Faktor in der Pathogenese und im Verlauf der koronaren Herzkrankheit diskutiert [6, 11].

In a case control study 192 cigarette-smoking patients with Type 1 (insulin-dependent) diabetes were compared with 192 non-cigarette-smoking patients pair-matched for sex (90 females), duration of diabetes (mean 14 years), and age (mean 32 years). Macroproteinuria was found in 19.3% of the smoking and in 8.3% of the non-smoking patients (p less than 0.001). Proliferative retinopathy was present in 12.5% of the smoking and in 6.8% of the non-smoking patients (p less than 0.025). The percentages of patients with normal proteinuria or without retinopathy were comparable between the two groups. In addition, glycosylated haemoglobin values and the prevalence of hypertension were similar between smoking and non-smoking patients. Thus, cigarette-smoking appears to be a risk factor for the progression of incipient to overt nephropathy and of background to proliferative retinopathy in Type 1 diabetes.

In the present investigation the influence of muscular exercise on non-glucoregulatory hormones (T3, rT3, T4, TSH, prolactin) was analyzed in non-ketotic, juvenile-onset type diabetics (JD) in relation of their metabolic control. The plasma hormonal concentrations were measured in 8 well-controlled JD, 8 moderately controlled JD and in 8 healthy subjects, before, during and after a 30 min. bicycle ergometer test of moderate work intensity. The exercise-induced rise in T4, and rT3 was similar in both groups of diabetics and did not significantly differ with that obtained in controls. A significant increase of T3-concentrations occurred only in the controls. Hormone levels of TSH, FSH and LH did not change significantly during exercise in all three groups, whereas prolactin showed a considerable increase (N. S.) in the well-controlled JD-patient group with low blood glucose concentrations. These findings demonstrate that muscular exercise leads to a similar effect on the behavior of T4, rT3, TSH, LH, and FSH concentrations, but not on T3 (no increase) and prolactin in non-ketotic, conventionally treated JD compared with healthy individuals.

Recently new radioimmunoassay methods have been established to measure plasma concentrations of beta-thromboglobulin (beta-TG) and platelet factor 4 (PF4), platelet release products which are set free when platelets aggregate. Plasma concentrations of beta-TG and PF4 were investigated in disorders with increased thromboembolic risk. Extremely high concentrations of these platelet proteins were found in patients with venous thrombosis, pulmonary embolism, polycythemia vera, and chronic renal failure. Moderately increased beta-TG and PF4 levels were observed in patients with peripheral vascular disease, coronary artery disease, chronic rheumatoid arthritis, multiple myeloma, and diabetes mellitus. These data indicate, that plasma concentrations of beta-TG and PF4 are useful parameters for the evaluation of the "in vivo" platelet activity. By using these new methods for clinical applications special blood sampling conditions have been taken into account; moreover one has to consider that the plasma levels of the platelet "release products" are dependent from renal function.

Unselected type I diabetics were hospitalized for group training and treatment programme during which blood-sugar was self-monitored with the Haemo-Glukotest 20-800; quality of self-monitoring improved appropriately. The patients had taken part in either the standard training programme (67 patients) or in the "intensive" training programme (101 patients). At the beginning of the training week, after the first theoretical and practical instructions, the quality of blood-sugar self-monitoring was equally poor among patients of both programmes. At the end of the "standard" training week, self-monitoring results were still unsatisfactory, though slightly better than at the onset. Because of these poor results, the training programme was intensified. Optimal quality of self-monitoring was then achieved at the end of the training period. In 69 others, also unselected, type I diabetics the quality of self-monitoring was determined 14 months after their participation in the training programme. Using the Haemo-Glukotest 20-800 (57 patients), self-monitoring gave excellent results; using a blood-glucose measuring instrument (12 patients) it was slightly worse. Assuming intensive training, even unselected type I diabetics can obtain accurate blood-sugar measurements using test-strips.

Any successful treatment of type-I diabetic patients has to be based upon a detailed education of the diabetic patient in order to enable him to selfmanage his disease as much as possible. The goals of diabetes-therapy (i.e. near-normalization of glycaemia in order to prevent diabetic microangiopathy at as high a quality of life as possible) can only be achieved by actively involving the patient in his/her therapy. Thus patient education becomes the cornerstone of modern diabetes-care. The evaluation of diabetes-education has--eventually--be based upon an assessment of the quality of metabolic control. A number of studies have proven that effective diabetes-education programmes can substantially improve long-term metabolic control and the incidence of acute complications in type I diabetic patients. At present, it appears that the most efficient way to improve the overall quality of diabetes-care is to improve diabetes-education delivered to the patients.

Bei Patienten mit Diabetes mellitus besteht gegenuber der Normalbevolkerung ein deutlich erhohtes Risiko fur atherosklerotische Spatschaden. Unter einer Anzahl von Faktoren, die in der Pathogenese der diabetischen Gefasveranderungen diskutiert werden, durften Fettstoffwechselstorungen eine nicht unbedeutende Rolle spielen. Wahrend bei nichtdiabetischen Patienten ein negativer Zusammenhang zwischen Lipoproteinen hoher Dichte und klinisch manifesten atherosklerotischen Gefasveranderungen durch viele Studien [8, 10, 16, 17, 21, 24] belegt ist, konnte eine klare negative Assoziation zwischen HDL-Cholesterinwerten und Atheroskleroserisiko bei Diabetikern bisher nicht nachgewiesen werden. So wurden bei Patienten mit Diabetes mellitus im Vergleich zur Normalbevolkerung erniedrigte [13], normale [1], aber auch erhohte [18] HDL-Cholesterinwerte in Abhangigkeit von Diabetestyp und Therapieform berichtet.

Plasma concentrations of immune-reactive trypsin (IRT) were determined in 212 patients with juvenile-onset, insulin-dependent diabetes (Type I) and in 158 patients with maturity onset diabetes (Type II) in comparison to 121 healthy individuals. Significantly increased IRT levels were obtained in the type I diabetics, whereas IRT concentrations were normal or increased in the type II diabetic patients. Hypotrypsinemia occurred predominantly in type I diabetics with high IgG-insulin antibodies or islet-cell antibodies. No correlation was noted between the IRT-levels and the beta-cell residual capacity in the type-I diabetics.

In the present study we investigated the influence of muscular exercise on stress-hormones (cortisol, growth hormone, epinephrine, norepinephrine) in nonketotic, juvenile-type diabetics (JD) in relation to the degree of metabolic control. The plasma-hormone-concentrations were measured in 8 well controlled JD, 8 moderately controlled JD and in 8 healthy subjects, before, during and after a 30 min bicycle ergometer test of moderate work intensity. The exercise induced rise in cortisol, epinephrine and norepinephrine wa similar in both groups of diabetics and not significantly different compared with controls. In healthy subjects growth hormone levels rose significantly with the onset of exercise, whereas in both patient groups maximal growth hormone concentrations were found at the end of the ergometer test. In moderately controlled JD, however, growth hormone concentrations were significantly higher than in well controlled JD. The results demonstrate that muscular exercise shows a similar effect on cortisol, epinephrine and norepinephrine, but not on growth hormone concentrations in nonketotic, conventionally treated JD compared with controls.

Objective data on duration of hospital stay and of incapacity to work were collected for 137 type I diabetics who had taken part in a structured diabetes treatment and training scheme. Before the training period the average hospital stay had been 0.76 per patient per year, duration per stay 21 days, number of episodes of work incapacity 1.6 per patient per year, duration of incapacity 23.6 days. For a subgroup of patients (62) the influence of the training programme could be demonstrated: hospital stay fell to 0.49 per patient per year, duration per stay to 12.0 days, number of incapacity episodes to 1.4 per patient per year, and the days lost from work to 12.1 per patient per year.

Glycosylated haemoglobin provides an integrative measure of long-term glycaemic levels and complements conventional glucose monitoring in the management of diabetes. The present study was determined to review nomenclature, biochemistry and the analytic methods available for measurement of HbA1. Clinical studies are reported that relate HbA1 concentrations to various parameters of glucose control, diabetes type and diabetes therapy. Moreover, this review considers nondiabetic disorders that are associated with falsely abnormal HbA1 levels and in addition, the value of HbA1 in predicting complications of diabetes and in the diagnosis of subclinical diabetes is discussed.

The mean plasma concentrations of beta-TG and PF4 were significantly elevated in patients with diabetes mellitus, peripheral vascular disease and coronary artery disease reflecting enhanced in vivo platelet activity in some of these patients. No correlations could be observed between state of metabolic control and concentrations of platelet specific proteins in diabetic subjects. High mean beta-TG levels were noticed in diabetic patients with increasing severity of retinopathy. Raised beta-TG values decreased significantly after two weeks of treatment with dipyridamole in 10 type-I diabetics. In patients with peripheral vascular disease the WU-test, but not the ADP- or collagen induced platelet aggregation was significantly different between patients and controls, but there were no correlations between the mentioned platelet function tests.