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Gabriele Meyer

Publications and source records attributed to Gabriele Meyer.

At least 19 recordsLinked to original sources

[Surrogate end point fallacies -- the urge for randomized trials with clinical endpoints].

Evidence increases that reliance on surrogate endpoints may be detrimental. This is particularly relevant for preventive medicine. Most impressive examples are hormone replacement therapy, vitamin therapy, and drug treatment of cardiovascular risk factors. Only a few of the oral antidiabetic agents have been studied in randomised trials using clinically relevant outcome measures. Most of these drugs or drug combinations turned out to be more dangerous than beneficial. They increased morbidity and mortality despite their blood glucose lowering effects (surrogate endpoints). New compounds are used without evidence of clinical benefit in millions of people worldwide. There is also an increasing number of examples on surrogate end point fallacies related to non-drug interventions (psychological, nursing, educational, social policy).

Endpoint Determination↗

The Tinetti test: Babylon in geriatric assessment.

The Tinetti test has been recommended and widely used in the elderly to assess mobility, balance and gait, and predict falls. Different versions can be found. A systematic literature search identified 37 publications on the Tinetti test and falls. Wide variations were found concerning name of the instrument, test items, scoring, and cut-off values. This heterogeneity interferes with evaluations of the test's validity, reliability and generalisability. Researcher and clinicians should be aware of this fact, when dealing with the Tinetti test.

Accidental Falls↗

Predicting the risk of falling--efficacy of a risk assessment tool compared to nurses' judgement: a cluster-randomised controlled trial [ISRCTN37794278].

BACKGROUND: Older people living in nursing homes are at high risk of falling because of their general frailty and multiple pathologies. Prediction of falls might lead to an efficient allocation of preventive measures. Although several tools to assess the risk of falling have been developed, their impact on clinically relevant endpoints has never been investigated. The present study will evaluate the clinical efficacy and consequences of different fall risk assessment strategies. STUDY DESIGN: Cluster-randomised controlled trial with nursing home clusters randomised either to the use of a standard fall risk assessment tool alongside nurses' clinical judgement or to nurses' clinical judgement alone. Standard care of all clusters will be optimised by structured education on best evidence strategies to prevent falls and fall related injuries. 54 nursing home clusters including 1,080 residents will be recruited. Residents must be > or = 70 years, not bedridden, and living in the nursing home for more than three months. The primary endpoint is the number of participants with at least one fall at 12 months. Secondary outcome measures are the number of falls, clinical consequences including side effects of the two risk assessment strategies. Other measures are fall related injuries, hospital admissions and consultations with a physician, and costs.

Accidental Falls↗

Increased use of hip protectors in nursing homes: economic analysis of a cluster randomized, controlled trial.

OBJECTIVES: To assess the cost-efficacy of an intervention program aimed at reducing hip fractures. DESIGN: Economic evaluation within an 18-month cluster randomized trial. SETTING: Forty-nine nursing homes in Hamburg, Germany. PARTICIPANTS: Residents with a high risk of falling (intervention group (IG), n=459; control group (CG), n=483). INTERVENTION: Education session for nurses, who subsequently educated residents, and provision of three hip protectors per resident. CG care was optimized by providing brief information to nurses about hip protectors and providing two protectors per nursing home for demonstration purposes. MEASUREMENTS: Main outcomes were hip fractures, costs, and incremental cost-effectiveness ratio (ICER). RESULTS: The intervention was effective in reducing hip fractures (21 in the IG vs 42 in the CG) and resulted in a cost difference of 51 dollars per participant in favor of the CG (95% confidence interval covering cost saving of 242 dollars to cost expense of 325 dollars). Costs per additional hip fracture avoided were 1,234 dollars. Sensitivity analyses aimed at investigating robustness of the results to a real practice implementation scenario resulted in ICERs varying from 439 dollars to 1,693 dollars. Taking into account lower hip protector reimbursement levels, the intervention program would be cost saving (break-even point within the base case analysis=22 dollars per hip protector). CONCLUSION: A program consisting of education and provision of hip protectors might produce a slight increase in costs or might even be cost saving if the price of the hip protector could be decreased.

Aged↗

[Evaluation tools for patient information commonly used in Germany--a critical analysis].

The value of instruments for the evaluation of health- or patient information is a controversial issue. This article examines instruments that evaluate information materials on the basis of predefined quality criteria for evidence-based patient information. The aim is to prove whether the instruments commonly used in Germany can be recommended. A review of the literature and an internet search engine search were conducted to identify relevant international systematic reviews and instruments commonly used in Germany. Four instruments were identified for Germany: The quality seals "AFGIS" and "HON" and the checklists "Discern" and "Check-In". These were evaluated on the basis of the predefined criteria. The instruments predominantly address structural aspects. Aspects of content and content presentation are rarely considered. The instruments neglect relevant quality criteria for evidence-based patient information.

Evidence-Based Medicine↗

Predictors of adherence to the use of hip protectors in nursing home residents.

OBJECTIVES: To assess predictors of hip-protector use in nursing home residents under usual-care conditions and after intervention consisting of structured education of nurses and nursing home residents and provision of free hip protectors. DESIGN: Nested cohort analyses within a cluster randomized, controlled trial with 18 months follow-up. SETTING: Forty-nine nursing home clusters in Hamburg, Germany. PARTICIPANTS: Residents with at least one fall during the study period (intervention group, n=237; usual-care group, n=274). MEASUREMENTS: Use of hip protector while falling. Regression analyses were performed for each of the two cohorts of fallers using the time to the first fall without hip protector as the dependent variable. Predefined nursing home cluster-related parameters (center, staffing ratio, proportion of registered nurses in nursing staff, hip-protector use before study period) and resident-related parameters (sex, history of falls and fractures, fear of falling, urinary incontinence, use of walking aid, degree of disablement) were considered as explanatory variables. RESULTS: Under usual care, 97% of fallers (n=266), compared with 62% (n=148) in the intervention group, experienced at least one fall without hip protection. Using Cox proportional hazards models with and without frailty parameter (random cluster effect), the following predictors were identified: intervention group: use of walking aid, hazard ratio (HR)=1.53 (95% confidence interval (CI):0.98-2.39) and no urinary incontinence, HR=1.47 (95% CI:1.03-2.09); usual care: nursing staff per 10 residents, HR=0.78 (95% CI=0.63-0.96); high degree of disablement, HR=1.38 (95% CI=1.06-1.80); strong fear of falling, HR=0.78 (95% CI=0.60-1.02). The nursing home cluster was a significant predictor in the control group (P=.029), but not in the intervention group (P=.100). CONCLUSION: Only a few and weak predictors of hip-protector use of questionable relevance could be identified in both groups. Future research should concentrate on the implementation of interventions of proven efficacy, such as provision of hip protectors combined with structured education of staff and residents.

Accidental Falls↗

[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↗

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↗

[Effectiveness of liberal vs. conservative episiotomy in vaginal delivery with reference to preventing urinary and fecal incontinence: a systematic review].

Episiotomy is the most common surgical intervention in the world. In Europe the rate of episiotomy is approximately 30% (23). Reasons for this intervention are the reduction of risk for tears and incontinence. To assess the effects of restricted episiotomy in the prevention of urinary and faecal incontinence. Medline search for 1990-7/2002, Cochrane Library (Issue 2, 2002), GEROLIT and SOMED and the Internet. RCTs analysing restrictive or non-restrictive episiotomy were included if they had comprehensive randomisation, follow-up and exclusion of selection bias. Cohort studies were assessed to evaluate the risk of developing faecal incontinence. If possible, data were pooled. Included were all pregnant women with vaginal delivery. Intervention/exposition: Restrictive vs. liberal episiotomy (median, lateral or mediolateral). Incontinence rate (urine and stool) 3 months and 3 years post partum. All included randomised controlled studies met the criteria above, one randomised controlled study used blinded assessment of outcome parameter. Lots of follow-up was 33% (after 3 years). Cohort studies partly were retrospective. 2 randomised controlled studies measuring urinary incontinence were included. The rate for episiotomy was 60% in the intervention group with liberal episiotomy and 27% in the restricted group. No difference could be found in groups measuring urinary incontinence (RR 0.98, 95% CI 0.83-1.20). Only two included cohort studies measured the effect of episiotomy on faecal incontinence. The chance of developing faecal incontinence in association with episiotomy was more than threefold (OR = 3.64, 95% CI 2.15-6.14). Restrictive episiotomy neither effects the development of urinary incontinence of post partum women (RR 0.98 95%, CI 0.83-1.20) three months and three years after vaginal delivery, nor the risk for trauma. Women without episiotomy suffer significantly less from faecal incontinence (OR = 3.6). Further investigation is required to measure the effect of no intervention versus liberal episiotomy.

Episiotomy↗