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Biomedical subjects

I Mühlhauser

Publications and source records attributed to I Mühlhauser.

At least 19 recordsLinked to original sources
PubMed2006

Understanding of diabetes prevention studies: questionnaire survey of professionals in diabetes care.

AIMS/HYPOTHESIS: Diabetes prevention studies have reported reductions of diabetes risk by up to 60%. Since the underlying metabolic changes are small, the clinical significance of this effect may be overestimated. The present survey explores the extent to which different formats of presenting study results may influence diabetes healthcare professionals' perceptions of the importance of intervention effects on diabetes risk. SUBJECTS, MATERIALS AND METHODS: Participants of three European diabetes conferences (160 nurse educators, 112 physicians, 27 other professionals) were presented with a questionnaire that included nine items, in which results from three diabetes prevention studies were presented in different ways. RESULTS: Participation rate was 96%. Effects were interpreted as important or very important by 92% (255/276) when results were presented as proportions of subjects with diabetes (14% intervention group, 29% control group), by 87% (248/285) when results were communicated as a risk reduction of 57%, by 39% (110/284) when the corresponding fasting plasma glucose values were presented (mean difference 0.3 mmol/l), and by 18% (52/283) when glycosylated haemoglobin values were used (6.0 vs 6.1%). Corresponding results of the three diabetes prevention studies were rated as being of identical importance by only 23, 13 and 16% of participants, respectively. CONCLUSIONS AND INTERPRETATION: Healthcare professionals rate the benefit of preventive interventions substantially higher when changes in diabetes risk are communicated rather than related glycaemic parameters. Transformation of continuous metabolic data into diagnostic categories may impair understanding of study effects.

Allied Health Personnel↗
PubMed2006

Searching for diabetes decision aids and related background information.

AIMS: Patient decision aids (DAs) are interventions designed to help patients making informed decisions. DAs are complex interventions comprising a number of active components each essential to the proper functioning of the aid. Critical appraisal of DAs therefore requires access to information describing the incremental assessment of each stage in their development, including information about the theoretical funding, development processes, efficacy trials and long-term implementation. We explored the feasibility of identifying such information with conventional database search strategies. Our study was conducted only in the field of diabetes care. METHODS: The 'Inventory of Existing Patient Decision Aids', medline (PubMed) and the World Wide Web were used to identify DAs relevant for diabetes care. For tracking information concerning each developmental stage, the reference lists of the DAs, home pages of the authors, medline, embase, PsycINFO, cinahl, and the Cochrane database were searched systematically. RESULTS: A total of 13 DAs relevant for diabetes care were identified. The search for publications concerning their development yielded more than 3000 results, only 10 of which referred to at least one of the 13 DAs. No additional background information was found on the home pages of the authors. CONCLUSIONS: Conventional database search strategies do not allow the extraction of information about the stages in development of a DA. To facilitate critical appraisal of DAs, we propose the creation of an electronic database which provides information about available DAs, together with the relevant background literature, or to incorporate such a system into existing databases.

Decision Making↗
PubMed2005

Glycaemic control and severe hypoglycaemia following training in flexible, intensive insulin therapy to enable dietary freedom in people with type 1 diabetes: a prospective implementation study.

AIMS/HYPOTHESIS: The aim of this study was to evaluate the implementation of a course teaching flexible, intensive insulin therapy on glycaemic control and severe hypoglycaemia in routine care. METHODS: This is a continuous quality-assurance project involving hospital diabetes centres. Every third year each centre re-examines 50 consecutive patients (evaluation sample) 1 year after participation in the course. Ninety-six diabetes centres in Germany participated and 9,583 patients with type 1 diabetes (190 evaluation samples) were re-examined between 1992 and 2004. The intervention was a 5-day inpatient course for groups of up to ten patients with a fixed curriculum of education and training for dietary flexibility and insulin adjustment. The main outcome measures were HbA1c and severe hypoglycaemia. RESULTS: Mean baseline HbA1c was 8.1%, and had decreased to 7.3% at follow-up; incidence of severe hypoglycaemia was 0.37 events per patient per year prior to intervention and 0.14 after intervention. In mixed-effects models adjusted for effects of centres, age and diabetes duration, the mean difference was -0.7% (95% CI -0.9 to -0.6%, p<0.0001) for HbA1c and -0.21 events per patient per year (95% CI -0.32 to -0.11, p=0.0001) for severe hypoglycaemia, with similar results for evaluation samples, with a maximum of 10% of patients lost to follow-up. Before intervention, the incidence of severe hypoglycaemia was three-fold higher in the lowest quartile than in the highest quartile of HbA1c, whereas the risk was comparable across the range of HbA1c values after intervention. CONCLUSIONS/INTERPRETATION: Implemented as part of a continuous quality-assurance programme the self-management programme is effective and safe in routine care. Improvement of glycaemic control can be achieved without increasing the risk of severe hypoglycaemia.

Adult↗
PubMed2004

Validation of a quality of life questionnaire measuring the subjective fear of falling in nursing home residents.

A quality of life scale was developed to measure the subjective fear of falling in nursing home residents. We assessed the dimensions fear of falling, daily living and social life within a randomized controlled trial of hip protector use. The Nottingham Health Profile (NHP) was used for validation. Statistical analysis covered factor analysis, internal consistency of subscales, construct and discriminant validity. Factor analysis revealed three reliable components (Cronbach's Alpha): fear of falling (0.92), social restriction due to limited mobility (0.74) and restriction by clothes due to the hip protector (0.72). The subscales fear of falling and social restriction were significantly intercorrelated with all subscales of the NHP. The new tool is a reliable and valid measure of fear of falling in nursing home residents. However, generalizability and applicability are limited by the small proportion of subjects able to complete the tests.

Accidental Falls↗
PubMed2004

Steroid treatment for relapses in multiple sclerosis - the evidence urges shared decision-making.

OBJECTIVES: Therapy of acute relapses in multiple sclerosis with corticosteroids (CC) remains uncertain with respect to route, dosage and effectiveness. This makes the treatment of relapses a clinical field where 'shared decision-making (SDM)' could be of advantage for the patients. A prerequisite for SDM is the provision of evidence-based information for the patients. The British General Medical Council (GMC) has published ethical guidelines on seeking patients' consent for medical interventions, formulating topics of information patients need in order to make an informed treatment decision. METHODS: Medical databases were searched for evidence on the treatment of acute relapses with CC. RESULTS: The available evidence on relapse treatment is ambiguous and weak. It does not provide enough evidence to sufficiently inform patients following the topics formulated by the GMC. CONCLUSION: Good evidence is lacking, supporting the concept of SDM in the therapy of relapses.

Adrenal Cortex Hormones↗
PubMed2003

[Graduated compression stockings in surgery -- optional or obligatory?].

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: GCS should be integral part of DVT prophylaxis in surgical departments. Their ineffectiveness is likely in some surgical populations.

Anticoagulants↗
PubMed2003

Effect on hip fractures of increased use of hip protectors in nursing homes: cluster randomised controlled trial.

OBJECTIVE: To assess the effects of an intervention programme designed to increase use of hip protectors in elderly people in nursing homes. DESIGN: Cluster randomised controlled trial with 18 months of follow up. SETTING: Nursing homes in Hamburg (25 clusters in intervention group; 24 in control group). PARTICIPANTS: Residents with a high risk of falling (459 in intervention group; 483 in control group). INTERVENTION: Single education session for nursing staff, who then educated residents; provision of three hip protectors per resident in intervention group. Usual care optimised by brief information to nursing staff about hip protectors and provision of two hip protectors per cluster for demonstration purposes. MAIN OUTCOME MEASURE: Incidence of hip fractures. RESULTS: Mean follow up was 15 months for the intervention group and 14 months for the control group. In total 167 residents in the intervention group and 207 in the control group died or moved away. There were 21 hip fractures in 21 (4.6%) residents in the intervention group and 42 hip fractures in 39 (8.1%) residents in the control group (relative risk 0.57, absolute risk difference -3.5%, 95% confidence interval -7.3% to 0.3%, P=0.072). After adjustment for the cluster randomisation the proportions of fallers who used a hip protector were 68% and 15% respectively (mean difference 53%, 38% to 67%, P=0.0001). There were 39 other fractures in the intervention group and 38 in the control group. CONCLUSION: The introduction of a structured education programme and the provision of free hip protectors in nursing homes increases the use of protectors and may reduce the number of hip fractures.

Accidental Falls↗
PubMed2002

Patient education - evaluation of a complex intervention.

Diabetes education or self-management programmes are complex interventions. Their evaluation is difficult because of problems in identifying and separately assessing the effect of the various components of the intervention. A phased approach defining sequential stages of a continuum of increasing evidence has been proposed as a framework for the design and evaluation of such complex interventions. As an example we present the available evidence for diabetes treatment and teaching programmes implemented in Germany. Evidence is compiled for structured group treatment and teaching programmes for Type I diabetes, non-insulin dependent Type II diabetes, and hypertension according to the following sequential stages of increasing evidence: (i) preclinical or theoretical phase; (ii) modelling the components of the intervention; (iii) exploratory trials; (iv) randomized controlled trials; (v) phase of implementation including replication and transfer to different settings. Evidence for most of these phases has been generated for the three programmes, although individual studies do not fulfill all important quality criteria by today's standards. The time span for gathering the evidence from the theoretical phase to surveillance after implementation was about 20 years. It can only be speculated which parts of the programmes are the most active ones. The presentation of a continuum of increasing evidence for diabetes education or self-management programmes could provide useful information for the appraisal of such complex interventions. Since this evidence cannot be readily extracted from databases we suggest that other research groups present their data in a similar way.

Diabetes Mellitus, Type 1↗
PubMed2002

Reliability of causes of death in persons with Type I diabetes.

AIMS/HYPOTHESIS: To compare causes of death assessed by a clinical review committee, the information given on death certificates, and ICD-codes provided by the State Documentation Office in deceased persons with Type 1 (insulin-dependent) diabetes mellitus. METHODS: A cohort of 3674 patients were monitored for 10+/-3 (mean +/- SD) years. Vital status and end-stage diabetic complications were documented for 97%; 251 patients had died. Causes of death were assessed by a clinical review committee and compared to the information provided by death certificates and ICD-9 codes. RESULTS: The review committee defined a leading cause of death in 94% of cases, whereas death certificates were available for 73% and ICD-codes for 79% of patients; 10% of death certificates could not be evaluated due to insufficient information. Diabetes was mentioned on 71% of death certificates, and renal disease in 75% of cases with renal replacement therapy. There was acceptable agreement between the committee, death certificates and ICD-codes only for deaths due to neoplasma, and between the committee and death certificates for deaths due to acute myocardial infarction, cerebrovascular events and accidents. In only one out of four deaths due to hypoglycaemia and in four of seven deaths due to ketoacidosis was this diagnosis mentioned on the death certificate. No death due to hypoglycaemia or ketoacidosis and 41% due to suicide were identifiable by ICD-codes. CONCLUSION/INTERPRETATION: Reliance on death certificates or ICD-codes as the only sources of information on the cause of specific mortality does not provide data of sufficient reliability for evaluation of clinical outcome in Type I diabetes.

Adult↗
PubMed2002

[Information on mammography screening--from deception to insight].

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.

Breast Neoplasms↗
PubMed2001

[Analysis of German language consumer information brochures on screening for colorectal cancer].

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.

Colonic Neoplasms↗
PubMed2000

Non-linear effects of blood pressure and glycosylated haemoglobin on progression of diabetic nephropathy.

OBJECTIVE: To describe the long-term simultaneous impacts of blood pressure and glycosylated haemoglobin values on the risk of progression of diabetic nephropathy. DESIGN: Prospective, multicentre, 6-year follow-up study. SETTING: One reference centre (university department of internal medicine) and nine general hospitals. SUBJECTS: A total of 601 type 1 diabetic patients on intensive insulin therapy with and without diabetic nephropathy. MAIN OUTCOME MEASURES: Progression of nephropathy was defined as change for the worse within five stages of nephropathy by at least one of these stages during the study period. By the use of logistic regression, the relationship between metabolic and blood pressure control and the risk of nephropathy progression was quantified. RESULTS: The main determinants of nephropathy progression were glycosylated haemoglobin and blood pressure, which were both non-linearly associated with the risk of progression. No significant threshold levels for any of the predictors of progression were identified. CONCLUSIONS: The results of this study underline the importance of optimizing metabolic and blood pressure control to arrest the progression of diabetic nephropathy without the evidence for a clinically relevant threshold effect.

Adult↗
PubMed2000

Prognosis of persons with type 1 diabetes on intensified insulin therapy in relation to nephropathy.

OBJECTIVE: To study the prognosis of persons with type 1 diabetes in relation to the degree of nephropathy at initiation of intensified insulin therapy. DESIGN: Ten years follow-up of a cohort of 3674 patients who had participated in a 5-day group treatment and teaching programme for intensification of insulin therapy between September 1978 and December 1994. SETTING: Ten diabetes centres in Germany. SUBJECTS: A total of 3674 patients (insulin treatment before age 31), age at baseline 27 +/- 10 years, with a diabetes duration of 11 +/- 9 years. Patients were divided into three groups according to baseline renal parameters (group I, normal proteinuria, n = 1829; group II, microproteinuria, n = 1257; group III, at least macroproteinuria, n = 367). MAIN OUTCOME MEASURES: End-stage diabetic complications (blindness, amputations, renal replacement therapy, standardized mortality ratios (SMR) and causes of death. RESULTS: Outcome measures were documented for 97% of patients; 251 (7%) had died. During follow-up, 1% of patients in group I, 4% in group II and 47% in group III had at least one end-stage diabetic complication. SMR for men: nephropathy group I, 2.2 (95% CI = 1.5-3); group II, 3.2 (2.3-4.3); group III, 11.5 (8.8-14.7). SMR for women: group I, 2.5 (1.5-3.8); group II, 3.5 (2.2-5.3); group III, 27 (19.8-35.9). Causes of death for men and women combined: group I (total 58 deaths)--cardiovascular, 21 (36%); hypoglycaemia, 1; ketoacidosis, 3; violent deaths, 17 (29%); others, 16; group II (66 deaths)--cardiovascular, 25 (38%); hypoglycaemia, 2; ketoacidosis, 2; violent deaths, 14 (21%); others, 23; group III (114 deaths)--cardiovascular, 68 (60%); hypoglycaemia, 2; ketoacidosis, 5; infections, 15 (13%); violent deaths, 5 (4%); others, 19. CONCLUSIONS: Patients with microproteinuria have only a slightly worse prognosis than patients with normal proteinuria during the first 10 years after initiation of intensified insulin therapy. Excess mortality amongst patients who started intensified insulin therapy is mainly due to those with manifest clinical nephropathy.

Adult↗
PubMed2000

Predictors of mortality and end-stage diabetic complications in patients with Type 1 diabetes mellitus on intensified insulin therapy.

AIMS: To assess predictors of mortality and end-stage diabetic complications in patients with Type 1 diabetes mellitus on intensified insulin therapy. METHODS: A cohort of 3,674 patients (insulin treatment before age 31) who had participated in a 5-day in-patient group treatment and teaching programme for intensification of insulin therapy between 9/1978 and 12/1994 were reassessed after 10 +/- 3 (mean +/- SD) years. RESULTS: Vital status and data on blindness, amputations, and renal replacement therapy were documented for 97% patients; 7% patients had died, 1.3% had become blind, 2% had amputations and 4.6% started renal replacement therapy. Using the Cox proportional hazards model, the following risk factors of mortality as assessed at baseline were identified: nephropathy (at least macroproteinuria), hazard ratio 3.8 (95% confidence interval 2.6-5.6); smoking, 1.9 (1.4-2.6); diabetes duration, 1.5 (1.2-1.8) for a difference of 10 years; serum cholesterol, 1.1 (1.0-1.2) for a difference of 1 mmol/l; lower social status, 1.4 (1.1-1.8) for a difference of 1 out of 3 levels; age, 1.3 (1.1-1.6) for a difference of 10 years; male sex, 1.4 (1.1-1.9); systolic blood pressure, 1.1 (1-1.2) for a difference of 10 mmHg. For the combined endpoint - blindness or amputations or renal replacement therapy - predictors were: nephropathy, foot complications, HbA1c, smoking, cholesterol, systolic blood pressure, retinopathy, hypertension, and social status. CONCLUSION: In Type 1 diabetic patients who start intensified insulin therapy, nephropathy remains the strongest predictor of mortality and end-stage complications. Glycosylated haemoglobin is a risk factor of end-stage complications but not of mortality. Conventional risk factors comparable to the general population, particularly smoking become operative as predictors of both mortality and end-stage complications.

Adult↗
PubMed2000

Evidence-based patient information in diabetes.

Patient education in diabetes has been successful in training and motivating patients to assume a more active and independent role in monitoring and treating their disease resulting in an improvement of patient-orientated outcomes. Traditionally, diabetes education has mainly aimed at increasing patient compliance to physician-defined therapeutic goals and treatment strategies. To strengthen their rights and autonomy, patients need to become more involved in medical decision making with respect to their individual therapeutic goals, such as HbA1c and blood pressure, body weight, etc., as well as choosing whether they pursue these goals. The importance of patient participatation is particularly relevant to Type 2 diabetes. Even perfect, long-term therapeutic co-operation will not eliminate diabetic complications, only reduce the risk of developing them. The benefits, lack of benefits and unwanted effects of various interventions need to be communicated to the patient in an unbiased manner, so that he/she can make an informed choice with regard to different therapeutic goals and strategies. In diabetes, ways of presenting patients with unbiased information to enable them to make such informed decisions are not yet available. We present ways of how this might be achieved using data provided by the UKPDS. The concept of patient participation in medical decision making represents a fundamental challenge for the future development of diabetes care.

Blood Pressure↗
PubMed2000

[Mammography screening: presentation of scientific evidence as a basis for communication with women].

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.

Adult↗