ISSN:0251-5350    

DOI:10.1159/000110386

出版商:S. Karger AG    

年代:1994

数据来源: Karger

ISSN:0251-5350    

DOI:10.1159/000110387

出版商:S. Karger AG    

年代:1994

数据来源: Karger

摘要:

Stroke data banks (SDBs) used for clinical research are between traditional case series and population-based studies. They can serve a multitude of purposes: estimating the burden of disease treated in one or several centers, calculating the recruitment rates for clinical trials, or for the detection of stroke incidence or time trends by means of a long-time observation in a defined geographical area. Some SDBs restrict themselves to the systematic collection of rare cases of stroke or to recurring strokes. The strength of an SDB lies in its ability to accumulate a large set of data within specified time frames using a defined set of diagnostic procedures. One of the most attractive features of an SDB is its generation of research hypotheses that allow one to look for similar patterns in related and in unrelated disorders. The overview in this volume is based on a literature search of SDBs published since 1980 and a questionnaire sent to the principal investigators applying ten criteria considered essential for clinical research: diagnostic criteria, separate analysis of first-ever strokes, CT investigation rate > 70%, integration of autopsy data, collection of prospective data wherever possible, planning of a pilot phase and interrater studies, constant screening procedures to identify patients enrolled and constant time frame of examinations, a large spectrum of clinical and investigative data, 12 months'' follow-up examinations, and a baseline paper describing the procedures used. When applying these criteria to the literature only 8 SDBs fulfilled them. The main reasons for exclusion were restriction to either one stroke subtype, one sex or a limited age group, no specification of stroke subtypes other than ischemic or hemorrhagic, follow-up examinations restricted to 1 month case fatalities.

ISSN:0251-5350    

DOI:10.1159/000110388

出版商:S. Karger AG    

年代:1994

数据来源: Karger

摘要:

Analytic issues in stroke data base research are reviewed, drawing upon relevant experiences in the analyses of three observational data bases from a variety of clinical fields. The specifics of the data base construct, statistical issues and variations in possible interpretations of results are discussed. Responsible analyses of and conservative inferences from observational data bases are stressed.

ISSN:0251-5350    

DOI:10.1159/000110389

出版商:S. Karger AG    

年代:1994

数据来源: Karger

摘要:

Observational data bases in the neurological disorders may be an important source of information on etiology and natural history. The ability to make valid generalizations of results from a data base to the general population of patients with a particular disorder is not, however, guaranteed. The design or analysis of the study may result in selection biases that make inferences untenable. Examples are presented which demonstrate the potential for bias limiting the validity of inferences beyond the sample observed.

ISSN:0251-5350    

DOI:10.1159/000110390

出版商:S. Karger AG    

年代:1994

数据来源: Karger

摘要:

The number of clinical trials to evaluate new therapies for stroke treatment and prevention is growing rapidly. Although stroke data banks cannot answer treatment efficacy questions, they can have powerful interactions with the design and conduct of clinical trials. Through data banks one can generate hypotheses regarding treatment, estimate the frequency of outcome events, calculate sample size, determine stratification factors that may or may not be needed in a clinical trial, establish inclusion and exclusion criteria and decide on the elements to include in the data collection forms. Using a data bank one can estimate the number of patients that may be screened, eligible, refused, and enrolled in a clinical trial with given inclusion and exclusion criteria. Data banks are helpful for surveillance of all eligible subjects and calculating the proportion of the total cases who were randomized. With the more widespread analyses of stroke data banks we can design focused clinical trials and reach some definitive conclusions regarding the future treatment of stroke.

ISSN:0251-5350    

DOI:10.1159/000110391

出版商:S. Karger AG    

年代:1994

数据来源: Karger

摘要:

This paper reviews the methodological issues in the epidemiological study of the outcome from stroke. Data are presented from an unselected series of patients in whom the underlying stroke pathology is clearly defined. Although the natural history varies among the different pathological subtypes of stroke, simple clinical baseline measures of the severity of the neurological deficit (incontinence, loss of consciousness and severity of paresis) and premorbid level of disability and social functioning independently predict disability-free survival by 1 year, and may help direct management and research.

ISSN:0251-5350    

DOI:10.1159/000110392

出版商:S. Karger AG    

年代:1994

数据来源: Karger

摘要:

Clinicians faced with a patient having a sudden-onset, focal neurological deficit must answer three fundamental questions: is it a stroke?, is it ischemia or hemorrhage? and what kind of ischemic stroke is it? Clinical information (that is, history and examination) is immediately available to every physician, and its role in answering these questions is extremely important, even though a 100% certainty can only be obtained with instrumental diagnostic tools. In fact, when diagnosis is based on properly designed clinical criteria, the percentage of diagnostic mistakes is quite low. Clinical methods are still the best way of orientating topographic and etiologic diagnosis, as well as prognosis. In addition, time might be saved if randomization in clinical trials could be done using clinical methods before complex investigations are applied.

ISSN:0251-5350    

DOI:10.1159/000110393

出版商:S. Karger AG    

年代:1994

数据来源: Karger

摘要:

The diversity of clinical syndromes and etiologies of stroke make stroke data banks one of the best tools to improve current knowledge of stroke. Hospital-based registries profit from a stroke team in the acute phase of the event and from access to special investigations. This leads to an earlier clinical and topographic diagnosis that may allow inclusion of the patient into acute trials within the therapeutic window. It also makes possible complete investigation in the acute period and broadens information on potential etiologies.

ISSN:0251-5350    

DOI:10.1159/000110394

出版商:S. Karger AG    

年代:1994

数据来源: Karger

摘要:

Studies of ethnic differences in frequency of disease can sometimes provide insights into etiologic mechanisms and, hopefully, lead to interventions that decrease risk and frequency of the disease. This principle can be applied to studies of stroke among blacks and whites. Blacks carry a disproportionate burden of strokes relative to the number of blacks in the population. In this paper, possible explanations for the differences are reviewed. It has been reported that certain risk factors for stroke, notably hypertension, are more common in blacks. However, it is unclear whether less access to medical care, difficulty with compliance in treatment programs, genetic differences in responsiveness to certain drugs or other genetic differences related to susceptibility are responsible for the consistently higher stroke frequency in blacks compared to whites. The frequency of stroke type also differs in these ethnic groups; whites are more prone to large vessel and embolic strokes whereas blacks suffer a higher frequency of small vessel and hemorrhagic stroke. When closely examining evidence, it is also unclear whether life-style, socioeconomic, or other factors can be implicated and even whether race plays any important role at all. All of these ethnic issues must carefully be considered in stroke data base research.

ISSN:0251-5350    

DOI:10.1159/000110395

出版商:S. Karger AG    

年代:1994

数据来源: Karger