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PubMed1985

[ Methodological evaluation and clinical significance of erythrocyte aggregation].

Red cell aggregation, which occurs in vivo when blood flow slows down, has been studied in 22 healthy subjects and 31 type I diabetics by means of Myrenne MA1 automatic aggregometer. First of all, the most reliable and precise technique has been studied: the best results have been obtained employing 25 microliters of K2-EDTA-anticoagulated blood stored between 0 and 20 degrees C for a maximum of 4 h. The present study has shown statistically significant differences (p = 0.01) between the two groups studied (controls: mean = 11.895 MEA +/- 0.863; diabetics: mean = 15.552 MEA +/- 0.985). Moreover, correlations between erythrocyte aggregability and hematochemical and rheological parameters like fibrinogen, ESR, serum proteins, plasma and blood viscosity, have been evaluated.

Blood Flow Velocity↗
PubMed1998

[Prospective registry of cerebrovascular diseases. Characterization of patients and methodology evaluation].

UNLABELLED: Hospital-based stroke data banks can contribute to a better management of stroke patients with consequent reduction of associated morbidity and mortality. OBJECTIVE: The characterisation of stroke patients and validation of the hospital stroke registry. SETTING: Hospital S.Pedro, Vila Real, a secondary neurological referral centre for 450.000 inhabitants of interior north Portugal. PATIENTS AND METHODS: Analysis of data collected over one year of a prospective computerised stroke registry. Evaluation of completeness of the registry by independent analysis from emergency room data files and percentage of items entirely filled up. RESULTS: in a one year period were registered 349 patients (186 F; 163 M) with a mean age at stroke of 69 years. The majority (73.3%) lived in the hospital district. Most patients went directly to the hospital from their homes, and in the first 24 hours of symptoms onset. Cerebral infarction was diagnosed in 35.2% of patients, followed from lacunas in 24.6% and hypertensive haemorrhages in 22.3%. Arterial hypertension was found in 60.1% of cases, there were 11.4% of deaths and a Rankin score > 3 was present at hospital discharge in 39.5% of patients. There was a decrease in the register during the one-year period, evaluated comparing two months of emergency room files; we found a missing rate of protocols items varying from 0.8% and 8.8%. CONCLUSIONS: Hospital-based stroke data banks can provide the best available information on stroke patients characteristics and the presence of stroke risk factors. Registry protocols must be kept simple, easy to fill and periodically surveyed in order to lessen the number of missing items.

Adult↗
PubMedDate not supplied

[Possibilities of standardized methodology for evaluating the society- and function-related characterization of the individual health status of senior citizens].

The present paper is a revised form of the report given at the Xth Congress of the Society for Gerontology of the GDR. Starting from an understanding of health expanded by the (objective) relation person-to-society, a general, introducing representation is given on the kind and tasks of the function-related evaluation methodology, on methodological problems connected therewith, and on essential fields of applications and their bounds.

Aged↗
PubMed2002

The TEAM methodology for the evaluation of information systems in biomedicine.

The TEAM evaluation methodology for information systems in biomedicine (Total Evaluation and Acceptance Methodology) is a unifying methodology for any computer-based information system based on a three dimensional framework; these dimensions being Role, Time and Structure. The theory is derived from how the information system relates to the general system where it should operate, the properties of information flow within a general system and the relation between a system and its models. As a system can in theory be modelled from many perspectives, a perspective to be modelled is built up by formulating criteria relevant to that perspective which can be evaluated by quantitative and qualitative assessment methods. Key characteristics of the methodology include the insistence on a global rather than partial approach to the evaluation of information systems, also the dynamic nature of an information system which is continually in modification as it more successfully deals with the inherent complexity of the environment in which it is operating. The role dimension identifies four main categories, designer, specialist user, end user and stakeholder from which several sub-categories may be identified. The time dimension has four main phases towards relative stability of the information system. The structural dimension distinguishes strategic, tactical or organisational and operational levels that often are confused together with risk of dilution in current approaches. It is believed that this framework and methodology can provide a basis for future standardisation of evaluation methodologies.

Evaluation Studies as Topic↗
PubMed2006

Is cosmetic surgery an effective psychotherapeutic intervention? A systematic review of the evidence.

PURPOSE: Elective cosmetic surgery (ECS) in the absence of physical indications is often performed to improve psychosocial function. Third-party funders need evidence of its effectiveness if they are to respond in an evidence-based way to increasing demand in the context of constrained resources. Our first aim was to review recent evidence of psychosocial outcome in a way that was systematic with respect to study inclusion and methodological evaluation. Our second aim was to review evidence for the validity of currently used selection criteria. METHOD: Electronic and manual literature and database search identified prospective cohort or controlled studies of psychosocial outcomes of surgery performed for appearance reasons reported in English from 1992 to 2004. Data were extracted to describe outcomes and evaluate methodological quality. RESULTS: Twenty-three reports of 22 separate studies were reviewed. All were prospective observational studies and most provided low standards of evidence because of the absence of comparison groups, short follow-up periods and loss to follow-up. The evidence suggests that breast reduction improves health-related quality of life, but does not indicate enduring improvement in quality of life after other procedures, or enduring improvement in mental health, self-esteem or body image after any procedure. Similarly, there was insufficient evidence for the validity of criteria for patient selection. The negative conclusions reflect, not the existence of negative evidence, but methodological limitations of published research. CONCLUSION: The problem for third-party funders is that, although evidence does not justify the continued general provision of ECS in the absence of physical need, it is not strong enough to justify withholding such treatment. Even though randomised controlled trials are probably impractical, we identify several improvements in design whereby future prospective cohort studies could provide higher standards of evidence.

Body Image↗
PubMed1997

Assessment of methodological practices in the evaluation of alcohol and other drug (AOD) abuse prevention.

No authoritative consensus has been achieved on which substance abuse prevention activities are effective for given populations. One response to concern about "what works" took the form of a National Structured Evaluation (NSE), mandated by the Anti-Drug Abuse Act of 1988. The present paper describes the NSE's pivotal task of determining whether evaluation methodologies applied to substance abuse prevention were adequate to produce credible findings. The lessons learned from this evaluation experience, in turn, offer guidance on changes that must be made in the application of evaluation methodology prior to a conclusive demonstration of the value of prevention efforts.

Alcoholism↗
PubMed2001

Methodological limitations of economic evaluations of antenatal screening.

A review of recent economic studies of antenatal screening reveals widespread violation of accepted economic evaluation methodology. In particular, the costs and benefits of antenatal screening are often misclassified and conflated, and the non-resource effects of averted costs are often excluded from the evaluation process. The result is a widespread violation of the explicit and systematic approaches taken by economic analysts more generally, and conclusions that may be described as misleading. This letter calls for economic analysts to be consistent in their application of economic evaluation methodology to antenatal screening programmes.

Abortion, Legal↗
PubMed1978

Cost-benefit and cost-effectiveness: methodologies for evaluating innovative pharmaceutical services.

Cost-benefit and cost-effectiveness analysis techniques which can be of assistance in the evaluation of innovative pharmaceutical services are reviewed. Process and outcome measures are considered, and suggested steps in a cost-benefit study are presented. Samples of pharmacy studies using these techniques are appraised. Possible measures for benefits and costs along with literature references for evaluations of innovative pharmaceutical services are presented. Areas of pharmaceutical service discussed are ambulatory patient consultation, unit dose drug distribution, drug information services, monitoring drug therapy in acute care and long-term care, parenteral admixture services, patient and therapy responsibilities, patient discharge interviews, patient drug histories and profiles, and personnel substitutions. Although there have been several encouraging reports on the cost-benefit of pharmaceutical services, more evaluative research is needed to develop programs which maximize the benefit-to-cost ratio to society.

Cost-Benefit Analysis↗
PubMed2003

Translation and cultural adaptation of quality of life questionnaires: an evaluation of methodology.

OBJECTIVE: To evaluate the methodological steps currently proposed in translation and cultural adaptation of quality of life questionnaires. METHODS: Fifty patients with rheumatoid arthritis were invited to participate. Two versions each of the Stanford Health Assessment Questionnaire (HAQ), the MOS 36 Item Short-Form Health Survey (SF-36), and the Arthritis Impact Measurement Scales 2 (AIMS-2) were administered: version 1 was a literal translation of the questionnaire; version 2 resulted from a process of translation and cultural adaptation following internationally accepted guidelines. For each patient we applied 2 questionnaires before and after consultation. The questionnaire, the order of administration, and the version were randomly assigned. The interviews were performed by a single interviewer. Several clinical and laboratory outcome measures were assessed simultaneously. Descriptive statistical analysis was used to characterize the data. Spearman and intraclass correlation coefficients were used to evaluate reliability and validity of each version of each questionnaire. RESULTS: Patients' mean (SD) age was 47 (12) years and mean (SD) disease duration was 10 (7) years. The differences of the mean in the physical and affective AIMS-2 components between the literal and adapted versions (0.21 and 0.11, respectively) were similar to the differences in the intraobserver application of the same version of culturally adapted AIMS-2 components (0.03 and 0.20) (the component scores range from 0 to 10). The same results were observed when considering other components of AIMS and SF-36, as well as HAQ scores. Version 1 and 2 presented a similar clinically and statistically significant correlation with clinical and laboratory measures used in the validation process of the questionnaires. CONCLUSION: The complex methodologies proposed in the translation and validation of the questionnaires should be carefully reevaluated. The simplification of this methodology should be studied.

Adult↗
PubMedDate not supplied

Methodology for the evaluation of drugs in pregnant women.

Although drugs are prescribed during pregnancy with some reluctance, they fulfill a real need in some circumstances. Adequate drug evaluation is thus essential, either based on efficacy and safety or mainly safety, using available data from non-pregnant women. Evaluation methodology is not fundamentally different during pregnancy. Recommendations for drug development are formulated on the basis of the most common situations as well as specific suggestions, thus raising the awareness of the different partners participating in healthcare (institutions, the pharmaceutical industry and prescribers). In particular, regulatory and economic incentives superimposed upon those recommendations adopted in Europe and the US for orphan diseases should be put into place to assist in the evaluation of drugs used in obstetrics. Medical needs in obstetrics should be better identified, and labelling of drugs for use during pregnancy should be better directed towards prescribers; a national registry of pregnancies should be established in France.

Clinical Trials as Topic↗