Hans-Joachim Trampisch

High prevalence of peripheral arterial disease and co-morbidity in 6880 primary care patients: cross-sectional study

We aimed to obtain reliable data on the epidemiology, co-morbidities and risk factor profile of peripheral arterial disease (PAD) in general medical practise. In the cross-sectional part of the observational German Epidemiological Trial on Ankle Brachial Index (getABI study), 344 general practitioners throughout Germany determined the ABI of consecutive, unselected patients aged 65 years or older with bilateral Doppler ultrasound measurements. Additional assessments comprised patient history with the focus on atherothrombotic diseases, physical examination, and the WHO questionnaire on intermittent claudication. A total of 6880 patients were included (42.0% male, mean age 72.5 years, mean body mass index 27.3 kg/m(2), mean systolic/diastolic blood pressure 143.7/81.3 mmHg). The prevalence of PAD for men/women as indicated by an ankle brachial index (AB1)<0.9 was 19.8/16.8%. Patients with PAD were slightly older than patients without PAD, suffered more frequently from diabetes (36.6 vs. 22.6%; adjusted OR: 1.8), hypertension (78.8 vs. 61.6%; OR: 2.2), lipid disorders (57.2 vs. 50.7%; OR: 1.3) and other coexisting atherothrombotic diseases (any cerebrovascular event: 15.0 vs. 7.6%; OR: 1.8; any cardiovascular event: 28.9 vs. 17.0%; OR: 1.5). The data highlight the high prevalence of PAD in primary care. PAD patients are characterised by a high co-morbidity, particularly with regard to other manifestations of atherothrombosis. Doppler ultrasound measurement for ABI determinations is a non-invasive, inexpensive, reliable tool in primary care and enables GPs to identify patients at risk of PAD.

Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial

BACKGROUND Our aim was to assess the efficacy of a part-standardised verum acupuncture procedure, in accordance with the rules of traditional Chinese medicine, compared with that of part-standardised sham acupuncture and standard migraine prophylaxis with beta blockers, calcium-channel blockers, or antiepileptic drugs in the reduction of migraine days 26 weeks after the start of treatment. METHODS This study was a prospective, randomised, multicentre, double-blind, parallel-group, controlled, clinical trial, undertaken between April 2002 and July 2005. Patients who had two to six migraine attacks per month were randomly assigned verum acupuncture (n=313), sham acupuncture (n=339), or standard therapy (n=308). Patients received ten sessions of acupuncture treatment in 6 weeks or continuous prophylaxis with drugs. Primary outcome was the difference in migraine days between 4 weeks before randomisation and weeks 23-26 after randomisation. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN52683557. FINDINGS Of 1295 patients screened, 960 were randomly assigned to a treatment group. Immediately after randomisation, 125 patients (106 from the standard group) withdrew their consent to study participation. 794 patients were analysed in the intention-to-treat popoulation and 443 in the per-protocol population. The primary outcome showed a mean reduction of 2 .3 days (95% CI 1.9-2.7) in the verum acupuncture group, 1.5 days (1.1-2.0) in the sham acupuncture group, and 2.1 days (1.5-2.7) in the standard therapy group. These differences were statistically significant compared with baseline (p<0.0001), but not across the treatment groups (p=0.09). The proportion of responders, defined as patients with a reduction of migraine days by at least 50%, 26 weeks after randomisation, was 47% in the verum group, 39% in the sham acupuncture group, and 40% in the standard group (p=0.133). INTERPRETATION Treatment outcomes for migraine do not differ between patients treated with sham acupuncture, verum acupuncture, or standard therapy.

Comparison of leg compression stocking and oral horse-chestnut seed extract therapy in patients with chronic venous insufficiency

BACKGROUND Diseases of the venous system are widespread disorders sometimes associated with modern civilisation and are among the major concerns of social and occupational medicine. This study was carried out to compare the efficacy (oedema reduction) and safety of compression stockings class II and dried horse chestnut seed extract (HCSE, 50 mg aescin, twice daily). METHODS Equivalence of both therapies was examined in a novel hierarchical statistical design in 240 patients with chronic venous insufficiency. Patients were treated over a period of 12 weeks in a randomised, partially blinded, placebo-controlled, parallel study design. FINDINGS Lower leg volume of the more severely affected limb decreased on average by 43.8 mL (n = 95) with HCSE and 46.7 mL (n = 99) with compression therapy, while it increased by 9.8 mL with placebo (n = 46) after 12 weeks therapy for the intention-to-treat group (95% CI: HCSE: 21.1-66.4; compression: 30.4-63.0; placebo: 40.0-20.4). Significant oedema reductions were achieved by HCSE (p = 0.005) and compression (p = 0.002) compared to placebo, and the two therapies were shown to be equivalent (p = 0.001); in this design, however, compression could not be proven as standard with regard to oedema reduction in the statistical test procedure. Both HCSE and compression therapy were well tolerated and no serious treatment-related events were reported. INTERPRETATION These results indicate that compression stocking therapy and HCSE therapy are alternative therapies for the effective treatment of patients with oedema resulting from chronic venous insufficiency.

Peripheral Arterial Disease as an Independent Predictor for Excess Stroke Morbidity and Mortality in Primary-Care Patients: 5-Year Results of the getABI Study

Background:There is controversial evidence with regard to the significance of peripheral arterial disease (PAD) as an indicator for future stroke risk. We aimed to quantify the risk increase for mortality and morbidity associated with PAD. Methods:In an open, prospective, noninterventional cohort study in the primary care setting, a total of 6,880 unselected patients ≧65 years were categorized according to the presence or absence of PAD and followed up for vascular events or deaths over 5 years. PAD was defined as ankle-brachial index (ABI) <0.9 or history of previous peripheral revascularization and/or limb amputation and/or intermittent claudication. Associations between known cardiovascular risk factors including PAD and cerebrovascular mortality/events were analyzed in a multivariate Cox regression model. Results:During the 5-year follow-up [29,915 patient-years (PY)], 183 patients had a stroke (incidence per 1,000 PY: 6.1 cases). In patients with PAD (n = 1,429) compared to those without PAD (n = 5,392), the incidence of all stroke types standardized per 1,000 PY, with the exception of hemorrhagic stroke, was about doubled (for fatal stroke tripled). The corresponding adjusted hazard ratios were 1.6 (95% confidence interval, CI, 1.1–2.2) for total stroke, 1.7 (95% CI 1.2–2.5) for ischemic stroke, 0.7 (95% CI 0.2–2.2) for hemorrhagic stroke, 2.5 (95% CI 1.2–5.2) for fatal stroke and 1.4 (95% CI 0.9–2.1) for nonfatal stroke. Lower ABI categories were associated with higher stroke rates. Besides high age, previous stroke and diabetes mellitus, PAD was a significant independent predictor for ischemic stroke. Conclusions:The risk of stroke is substantially increased in PAD patients, and PAD is a strong independent predictor for stroke.

Profound influence of different methods for determination of the ankle brachial index on the prevalence estimate of peripheral arterial disease

BackgroundThe ankle brachial index (ABI) is an efficient tool for objectively documenting the presence of lower extremity peripheral arterial disease (PAD). However, different methods exist for ABI calculation, which might result in varying PAD prevalence estimates. To address this question, we compared five different methods of ABI calculation using Doppler ultrasound in 6,880 consecutive, unselected primary care patients ≥65 years in the observational getABI study.MethodsIn all calculations, the average systolic pressure of the right and left brachial artery was used as the denominator (however, in case of discrepancies of ≥10 mmHg, the higher reading was used). As nominators, the following pressures were used: the highest arterial ankle pressure of each leg (method #1), the lowest pressure (#2), only the systolic pressure of the tibial posterior artery (#3), only the systolic pressure of the tibial anterior artery (#4), and the systolic pressure of the tibial posterior artery after exercise (#5). An ABI < 0.9 was regarded as evidence of PAD.ResultsThe estimated prevalence of PAD was lowest using method #1 (18.0%) and highest using method #2 (34.5%), while the differences in methods #3–#5 were less pronounced. Method #1 resulted in the most accurate estimation of PAD prevalence in the general population. Using the different approaches, the odds ratio for the association of PAD and cardiovascular (CV) events varied between 1.7 and 2.2.ConclusionThe data demonstrate that different methods for ABI determination clearly affect the estimation of PAD prevalence, but not substantially the strength of the associations between PAD and CV events. Nonetheless, to achieve improved comparability among different studies, one mode of calculation should be universally applied, preferentially method #1.

Are elevated homocysteine plasma levels related to peripheral arterial disease? Results from a cross‐sectional study of 6880 primary care patients

Background  It is still unclear whether the strength of the association between elevated plasma homocysteine (HC) levels and peripheral arterial disease (PAD), coronary artery disease (CAD) and cerebrovascular disease (CVD) is similar.

Prerequisites for a new health care model for elderly people with multimorbidity: the PRISCUS research consortium.

Fragestellung Das gleichzeitige Auftreten oder Vorhandensein mehrerer chronischer Erkrankungen im Sinne einer Multimorbiditat stellt den betroffenen Patienten, seine Angehorigen sowie Arzte und Therapeuten vor grose Herausforderungen. Das Gesundheitssystem wird durch die steigende Zahl Betroffener und ihre komplexen Bedurfnisse, aber auch durch die Vielfalt haufig schlecht koordinierter Interventionen zunehmend belastet. Zur Verbesserung der medizinischen Versorgung bietet sich das fur chronisch Kranke entwickelte „Chronic Care Model“ an. Der Forschungsverbund PRISCUS versucht, die Voraussetzungen fur ein daran orientiertes, neues Versorgungsmodell fur multimorbide, altere Patienten zu schaffen.BackgroundMultimorbidity, the concurrent manifestation or presence of multiple chronic conditions, poses huge challenges to affected patients, their relatives, physicians, and practitioners alike. The growing number of affected persons and the complexity of their needs places just as much of a burden on the health care system as does the plethora of often poorly coordinated interventions. The Chronic Care Model developed for different chronic diseases is suited for improving medical care. The PRISCUS research consortium was established to create the prerequisites for a new care model for multimorbid, elderly patients oriented along those lines.MethodsThe research consortium utilizes data gathered in a large-scale epidemiological study on peripheral arterial disease (getABI study) and from the Dortmund and Münster stroke registries, by extracting epidemiologic and health economic data, quality-of-life parameters, and data on the extent and quality of medication. Additional projects evaluate the implementation of a multidimensional geriatric assessment in primary care, the functional consequences of multimorbidity in stroke patients along with options for prevention and therapy afforded by physical activity. Systematic reviews of the literature are used to describe quality of life and patient preferences. Experts will work on an initial draft treatment standard for patients with multimorbidity and a list of potentially inappropriate medication for the elderly in Germany.ConclusionThe results of the PRISCUS research consortium will enable an epidemiologic characterization and description of consequences of multimorbidity, while illustrating new approaches towards prevention, diagnosis, and management of multimorbid patients. With this, some prerequisites for a new health care model for patients with multimorbidity comparable to the Chronic Care Model will be fulfilled.ZusammenfassungFragestellungDas gleichzeitige Auftreten oder Vorhandensein mehrerer chronischer Erkrankungen im Sinne einer Multimorbidität stellt den betroffenen Patienten, seine Angehörigen sowie Ärzte und Therapeuten vor große Herausforderungen. Das Gesundheitssystem wird durch die steigende Zahl Betroffener und ihre komplexen Bedürfnisse, aber auch durch die Vielfalt häufig schlecht koordinierter Interventionen zunehmend belastet. Zur Verbesserung der medizinischen Versorgung bietet sich das für chronisch Kranke entwickelte „Chronic Care Model“ an. Der Forschungsverbund PRISCUS versucht, die Voraussetzungen für ein daran orientiertes, neues Versorgungsmodell für multimorbide, ältere Patienten zu schaffen.MethodikDer Verbund nutzt unter anderem Daten einer großen epidemiologischen Studie zur peripheren arteriellen Verschlusskrankheit (getABI-Studie) und Daten des Dortmunder und Münsteraner Schlaganfallregisters. Ermittelt werden epidemiologische und gesundheitsökonomische Daten, Parameter der Lebensqualität und Umfang und Qualität der medikamentösen Versorgung. In weiteren Projekten werden die Implementierung eines multidimensionalen Assessments in Hausarztpraxen, die funktionellen Auswirkungen von Multimorbidität bei Schlaganfallpatienten sowie Möglichkeiten der Prävention und Therapie mittels körperlicher Aktivität evaluiert. Über systematische Literaturübersichten werden Lebensqualität und Patientenpräferenzen dargestellt. Mit Hilfe von Experten wird ein erster Behandlungsstandard für Patienten mit Multimorbidität und eine Liste potentiell inadäquater Medikamente im Alter erarbeitet.FazitDie Ergebnisse des Forschungsverbunds werden eine epidemiologische Charakterisierung und eine Abschätzung der Krankheitsfolgen von Multimorbidität erlauben. Der Verbund wird neue Ansätze zu Prävention, Diagnostik und Therapie bei Multimorbidität aufzeigen können. Damit werden erste Voraussetzungen geschaffen, durch Anpassung der Versorgungsstruktur nach Vorbild des „Chronic Care Model“ ein verbessertes Management von Patienten mit Multimorbidität zu erreichen.

Feasibility of a multidimensional home-based exercise programme for the elderly with structured support given by the general practitioner's surgery: Study protocol of a single arm trial preparing an RCT (ISRCTN58562962)

BackgroundPhysical activity programmes can help to prevent functional decline in the elderly. Until now, such programmes use to target either on healthy community-dwelling seniors or on elderly living in special residences or care institutions. Sedentary or frail people, however, are difficult to reach when they live in their own homes. The general practitioners (GP) practice offers a unique opportunity to acquire these people for participation in activity programmes. We conceptualised a multidimensional home-based exercise programme that shall be delivered to the target group through cooperation between GPs and exercise therapists. In order to prepare a randomised controlled trial (RCT), a feasibility study is being conducted.MethodsThe study is designed as a single arm interventional trial. We plan to recruit 90 patients aged 70 years and above through their GPs. The intervention lasts 12 weeks and consists of physical activity counselling, a home-exercise programme, and exercise consultations provided by an exercise therapist in the GPs practice and via telephone. The exercise programme consists of two main components: 1. a combination of home-exercises to improve strength, flexibility and balance, 2. walking for exercise to improve aerobic capacity. Primary outcome measures are: appraisal by GP, undesirable events, drop-outs, adherence. Secondary outcome measures are: effects (a. motor tests: timed-up-and-go, chair rising, grip strength, tandem stand, tandem walk, sit-and-reach; b. telephone interview: PRISCUS-Physical Activity Questionnaire, Short Form-8 Health Survey, three month recall of frequency of falls, Falls Efficacy Scale), appraisal by participant, exercise performance, focus group discussion. Data analyses will focus on: 1. decision-making concerning the conduction of a RCT, 2. estimation of the effects of the programme, detection of shortcomings and identification of subgroups with contrary results, 3. feedback to participants and to GPs.ConclusionA new cooperation between GPs and exercise therapists to approach community-dwelling seniors and to deliver a home-exercise programme is object of research with regard to feasibility and acceptance. In case of success, an RCT should examine the effects of the programme. A future implementation within primary medical care may take advantage from the flexibility of the programme.Trial registrationCurrent Controlled Trials ISRCTN58562962.

Prerequisites for a new health care model for elderly people with multimorbidity

Fragestellung Das gleichzeitige Auftreten oder Vorhandensein mehrerer chronischer Erkrankungen im Sinne einer Multimorbiditat stellt den betroffenen Patienten, seine Angehorigen sowie Arzte und Therapeuten vor grose Herausforderungen. Das Gesundheitssystem wird durch die steigende Zahl Betroffener und ihre komplexen Bedurfnisse, aber auch durch die Vielfalt haufig schlecht koordinierter Interventionen zunehmend belastet. Zur Verbesserung der medizinischen Versorgung bietet sich das fur chronisch Kranke entwickelte „Chronic Care Model“ an. Der Forschungsverbund PRISCUS versucht, die Voraussetzungen fur ein daran orientiertes, neues Versorgungsmodell fur multimorbide, altere Patienten zu schaffen.BackgroundMultimorbidity, the concurrent manifestation or presence of multiple chronic conditions, poses huge challenges to affected patients, their relatives, physicians, and practitioners alike. The growing number of affected persons and the complexity of their needs places just as much of a burden on the health care system as does the plethora of often poorly coordinated interventions. The Chronic Care Model developed for different chronic diseases is suited for improving medical care. The PRISCUS research consortium was established to create the prerequisites for a new care model for multimorbid, elderly patients oriented along those lines.MethodsThe research consortium utilizes data gathered in a large-scale epidemiological study on peripheral arterial disease (getABI study) and from the Dortmund and Münster stroke registries, by extracting epidemiologic and health economic data, quality-of-life parameters, and data on the extent and quality of medication. Additional projects evaluate the implementation of a multidimensional geriatric assessment in primary care, the functional consequences of multimorbidity in stroke patients along with options for prevention and therapy afforded by physical activity. Systematic reviews of the literature are used to describe quality of life and patient preferences. Experts will work on an initial draft treatment standard for patients with multimorbidity and a list of potentially inappropriate medication for the elderly in Germany.ConclusionThe results of the PRISCUS research consortium will enable an epidemiologic characterization and description of consequences of multimorbidity, while illustrating new approaches towards prevention, diagnosis, and management of multimorbid patients. With this, some prerequisites for a new health care model for patients with multimorbidity comparable to the Chronic Care Model will be fulfilled.ZusammenfassungFragestellungDas gleichzeitige Auftreten oder Vorhandensein mehrerer chronischer Erkrankungen im Sinne einer Multimorbidität stellt den betroffenen Patienten, seine Angehörigen sowie Ärzte und Therapeuten vor große Herausforderungen. Das Gesundheitssystem wird durch die steigende Zahl Betroffener und ihre komplexen Bedürfnisse, aber auch durch die Vielfalt häufig schlecht koordinierter Interventionen zunehmend belastet. Zur Verbesserung der medizinischen Versorgung bietet sich das für chronisch Kranke entwickelte „Chronic Care Model“ an. Der Forschungsverbund PRISCUS versucht, die Voraussetzungen für ein daran orientiertes, neues Versorgungsmodell für multimorbide, ältere Patienten zu schaffen.MethodikDer Verbund nutzt unter anderem Daten einer großen epidemiologischen Studie zur peripheren arteriellen Verschlusskrankheit (getABI-Studie) und Daten des Dortmunder und Münsteraner Schlaganfallregisters. Ermittelt werden epidemiologische und gesundheitsökonomische Daten, Parameter der Lebensqualität und Umfang und Qualität der medikamentösen Versorgung. In weiteren Projekten werden die Implementierung eines multidimensionalen Assessments in Hausarztpraxen, die funktionellen Auswirkungen von Multimorbidität bei Schlaganfallpatienten sowie Möglichkeiten der Prävention und Therapie mittels körperlicher Aktivität evaluiert. Über systematische Literaturübersichten werden Lebensqualität und Patientenpräferenzen dargestellt. Mit Hilfe von Experten wird ein erster Behandlungsstandard für Patienten mit Multimorbidität und eine Liste potentiell inadäquater Medikamente im Alter erarbeitet.FazitDie Ergebnisse des Forschungsverbunds werden eine epidemiologische Charakterisierung und eine Abschätzung der Krankheitsfolgen von Multimorbidität erlauben. Der Verbund wird neue Ansätze zu Prävention, Diagnostik und Therapie bei Multimorbidität aufzeigen können. Damit werden erste Voraussetzungen geschaffen, durch Anpassung der Versorgungsstruktur nach Vorbild des „Chronic Care Model“ ein verbessertes Management von Patienten mit Multimorbidität zu erreichen.

A new efficient trial design for assessing reliability of ankle-brachial index measures by three different observer groups

BackgroundThe usual method of assessing the variability of a measure such as the ankle brachial index (ABI) as a function of different observer groups is to obtain repeated measurements. Because the number of possible observer-subject combinations is impractically large, only a few small studies on inter- and intraobserver variability of ABI measures have been carried out to date. The present study proposes a new and efficient study design. This paper describes the study methodology.MethodsUsing a partially balanced incomplete block design, six angiologists, six primary-care physicians and six trained medical office assistants performed two ABI measurements each on six individuals from a group of 36 unselected subjects aged 65–70 years. Each test subject is measured by one observer from each of the three observer groups, and each observer measures exactly six of the 36 subjects in the group. Each possible combination of two observers occurs exactly once per patient and is not repeated on a second subject. The study involved four groups of 36 subjects (144), plus standbys.ResultsThe 192 volunteers present at the study day were similar in terms of demographic characteristics and vascular risk factors: mean age 68.6 ± 1.7; mean BMI 29.1 ± 4.6; mean waist-hip ratio 0.92 ± 0.09; active smokers 12%; hypertension 60.9%; hypercholesterolemia 53.4%; diabetic 17.2%. A complete set of ABI measurements (three observers performing two Doppler measurements each) was obtained from 108 subjects. From all other subjects at least one ABI measurement was obtained. The mean ABI was 1.08 (± 0.13), 15 (7.9%) volunteers had an ABI <0.9, and none had an ABI >1.4, i.e. a ratio that may be associated with increased stiffening of the arterial walls.ConclusionThis is the first large-scale study investigating the components of variability and thus reliability in ABI measurements. The advantage of the new study design introduced here is that only one sixth of the number of theoretically possible measurements is required to obtain information about measurement errors. Bland-Altman plots show that there are only small differences and no systematic bias between the observers from three occupational groups with different training backgrounds.