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Biomedical subjects

Franz Porzsolt

Publications and source records attributed to Franz Porzsolt.

9 recordsLinked to original sources
PubMed2007

The value of health care--a matter of discussion in Germany.

BACKGROUND: Interest in assessing the value of health-care services in Germany has considerably increased since the foundation of the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG (Institute for Quality and Efficiency in Health Care). The practical application of value assessment illustrates how problematic the process can be. In all decisions made for the provision of health care, data concerning the measurable dimensions (quantity and quality of efficacy and effectiveness, validity of the results and costs) flow into a complex and not yet standardized decision-making process concerning public financing. Some of these decisions are based on data of uncertain validity, unknown reproducibility and unclear appropriateness. DISCUSSION: In this paper we describe the theoretical aspects of value from psychological and economic viewpoints and discuss national and international approaches. Methodic details and difficulties in assessing the value of health-care services are analysed. A definition of the intangible value of health-care services will be proposed which contains only three factors: the absolute risk reduction (usually a measure of efficacy), the validity of the scientific papers examined and the type of the expected effectiveness (prevention of death and disability, restitution of well-being). The intangible value describes the additional benefit when comparing two possible actions, like treatment or observation only. CONCLUSION: The description of intangible value from the viewpoint of different stakeholders is a useful measure for subsequent steps (not discussed here) - the evaluation of costs and of patient benefit. A standardised, transparent, fair and democratic evaluation is essential for the definition of a basic benefit package.

Attitude to Health↗
PubMed2006

The fading of reported effectiveness. A meta-analysis of randomised controlled trials.

BACKGROUND: The "real" effect size of a medical therapy is constant over time. In contrast, the effect size reported in randomised controlled trials (RCTs) may change over time because the sum of all kinds of bias influencing the reported effectiveness is not necessarily constant. As this would affect the validity of meta-analyses, we tested the hypothesis that the reported effect size decreases over time. Furthermore, we tested three hypotheses that would explain a possible change. METHODS: Because of well established outcome measures, the lipid-lowering drugs Pravastatin and Atorvastatin (serum low-density lipoprotein cholesterol, LDL-C) and the anti-glaucoma drugs Timolol and Latanoprost (intraocular pressure, IOP) were chosen for this investigation. Studies were identified by a standardized MEDLINE search. RCTs investigating the above identified medications administered as monotherapy, and in defined dosages, were included. Publication year, baseline (= pre-treatment value in the treatment group of interest) and post intervention means, number of patients and the assignment to experimental or control group were extracted for each study. RESULTS: A total of 625 citations were screened; 206 met the inclusion criteria. The reported effect size of Pravastatin (change of reported effect size in five years: -3.22% LDL-C, P < .0001), Timolol (-0.56 mmHg, P < .0001) and Latanoprost (-1.78 mmHg, P = .0074) decreased over time, while there was no significant change for Atorvastatin (+0.31% LDL-C, P = .8618). Multiple regression analysis showed that baseline values were the most important influencing factor; study size or treatment group did not play a significant role. CONCLUSION: The effectiveness of medical therapies reported in RCTs decreases over time in three of the four investigated pharmaceuticals, caused mainly by baseline differences. We call this phenomenon "fading of reported effectiveness". Under this condition the validity of a meta-analysis may be impaired. Therefore we propose to observe this phenomenon in future meta-analyses in order to guarantee a maximum of transparency.

Adrenergic beta-Antagonists↗
PubMed2005

When to recommend and to pay for first-line adjuvant breast cancer treatment? A structured review of the literature.

A structured review of studies on the health-economic evaluation of systemic adjuvant therapy for early-stage breast cancer was carried out. Of the eight articles that have been identified four were related to the cost-effectiveness of chemotherapy, three compared chemotherapy with combined chemotherapy and hormonal therapy and one compared tamoxifen (TAM) with third-generation aromatase inhibitors (ATIs). Results of the review indicate that the cost-utility of adjuvant breast cancer therapy is within the range of other oncological interventions. Adjuvant chemotherapy is most cost-effective in pre-menopausal women with node-positive breast cancer while cost-effectiveness decreases considerably with increasing age. Endocrine therapy with TAM is most cost-effective in ER-positive tumours with no significant age effect. The cost-utility of using the ATI anastrozole instead of TAM in adjuvant therapy cannot be conclusively assessed on the basis of the existing evidence.

Aromatase Inhibitors↗
PubMed2005

Sicily statement on evidence-based practice.

BACKGROUND: A variety of definitions of evidence-based practice (EBP) exist. However, definitions are in themselves insufficient to explain the underlying processes of EBP and to differentiate between an evidence-based process and evidence-based outcome. There is a need for a clear statement of what Evidence-Based Practice (EBP) means, a description of the skills required to practise in an evidence-based manner and a curriculum that outlines the minimum requirements for training health professionals in EBP. This consensus statement is based on current literature and incorporating the experience of delegates attending the 2003 Conference of Evidence-Based Health Care Teachers and Developers ("Signposting the future of EBHC"). DISCUSSION: Evidence-Based Practice has evolved in both scope and definition. Evidence-Based Practice (EBP) requires that decisions about health care are based on the best available, current, valid and relevant evidence. These decisions should be made by those receiving care, informed by the tacit and explicit knowledge of those providing care, within the context of available resources. Health care professionals must be able to gain, assess, apply and integrate new knowledge and have the ability to adapt to changing circumstances throughout their professional life. Curricula to deliver these aptitudes need to be grounded in the five-step model of EBP, and informed by ongoing research. Core assessment tools for each of the steps should continue to be developed, validated, and made freely available. SUMMARY: All health care professionals need to understand the principles of EBP, recognise EBP in action, implement evidence-based policies, and have a critical attitude to their own practice and to evidence. Without these skills, professionals and organisations will find it difficult to provide 'best practice'.

Adult↗
PubMed2005

Validity of original studies in health technology assessment reports: significance of standardized assessment and reporting.

OBJECTIVES: As health technology assessments (HTA) may have considerable impact on health-care decisions, it is essential to guarantee the expected quality of these assessments. Variations in the methods used or lack of transparency can affect the important role of HTA reports. METHODS: In our study, we analyzed the methods used in two corresponding HTA reports to assess the validity of two key papers, which were included in both reports. Also the discussions and the final conclusions of both reports were compared. RESULTS: The authors of the two HTA reports used different instruments to assess the validity of the original studies. A minor problem is differences that were found in the assessments of identical validity aspects of the included studies and in the information provided in the HTA reports. A more serious problem was found in both HTA reports which identified the weakness of the key papers and expressed these limitations in the discussions (read mainly by scientists) but not in the conclusions (read mainly by policy-makers). CONCLUSIONS: The results of this study may be important for any institution that prepares recommendations for policy-makers. In the case of HTA reports, no new checklists are necessary as the checklist offered by the INAHTA contains the needed information. It may be necessary, however, to consider an "intramural quality board," which helps the member organizations guarantee both the transparency of the original studies included in HTA reports and the transparency of the HTA report itself.

Reproducibility of Results↗
PubMed2004

A new instrument to describe indicators of well-being in old-old patients with severe dementia--the Vienna List.

BACKGROUND: In patients with very severe dementia self-rating of quality of life usually is not possible and appropriate instruments for proxy-ratings are not available. The aim of this project is to develop an instrument of clinical proxy-ratings for this population. METHODS: Using electronic instruments, physicians and nurses recorded patient behaviour and changes of behaviour over a period of one year. Based on these data a list of 65 items was generated and subsequently allocated to 14 categories. This list was tested in 217 patients (61-105 yrs) with dementia diagnosed according to ICD-10 by both physicians and nurses. The severity of dementia was assessed by means of the Global Deterioration Scale (GDS) and the Brief Cognitive Rating Scale (BCRS). The Spitzer-Index (proxy-rating) was used as a global quality of life measure. Activity of daily living was rated using the Barthel Index. RESULTS: A factor analysis of the original 65 items revealed 5 factors (communication, negative affect, bodily contact, aggression, and mobility). By stepwise removing items we obtained satisfactory internal consistencies of the factors both for nurses' and physicians' ratings. The factors were generally unrelated. The validity of the instrument was proven by correlations of the factors communication and mobility with the Brief Cognitive Rating Scale (BCRS) and the Barthel-Index. CONCLUSION: The results demonstrate the reliability and validity of the Vienna List as a proxy rating measurement of quality of life in patients with severe dementia. The psychometric properties of the scale have to be proved in further studies.

Activities of Daily Living↗
PubMed2004

Applying evidence to support ethical decisions: is the placebo really powerless?.

Using placebos in day-to-day practice is an ethical problem. This paper summarises the available epidemiological evidence to support this difficult decision. Based on these data we propose to differentiate between placebo and "knowledge framing". While the use of placebo should be confined to experimental settings in clinical trials, knowledge framing--which is only conceptually different from placebo--is a desired, expected and necessary component of any doctor-patient encounter. Examples from daily practice demonstrate both, the need to investigate the effects of knowledge framing and its impact on ethical, medical, economical and legal decisions.

Decision Making↗