Aktuelle Projekte und Veröffentlichungen
Hier finden Sie Veröffentlichungen zu verschiedenen Themen unserer Mitglieder.
Alternative, Complementary, Medicine
| Porzsolt F, Eisemann M, Habs M. Complementary Alternative Medicine and Traditional Scientific Medicine should use identical rules to complete clinical trials. | https://www.sciencedirect.com/science/article/abs/pii/S1876382010000053 |
Porzsolt F. Alternativer Vorschlag. Leserbrief zu Kiene H et al. „Ärztliche Professionalität und Komplementärmedizin: Was ist seriöses Therapieren?“ | https://www.aerzteblatt.de/archiv/77329/Pluralismus-Alternativer-Vorschlag Originalbeitrag | |
Porzsolt F. Kroemer R, Silva-Sobrinho RA. The two sides of the value medal – confirmed or not confirmed by Real-Word Effectiveness? | ||
Comparative Effectiveness
| Porzsolt F. Priority setting in health care systems: too much or not enough. | |
Gehr BT, Weiss C, Porzsolt F. The fading of reported effectiveness. A meta-analysis of randomised controlled trials | ||
Ramos KD, Slavin M, Parkin C, Letelier LM, Harris J, Nabulsi M, Summerskill W, Porzsolt F, Sestini P. The effectiveness of education in Evidence-Based Health Care: the current state of outcome assessments and a framework for future evaluations. | ||
Porzsolt F, Rocha NG, Toledo-Arruda AC, Thomaz TG, Moraes C, Bessa-Guerra TR, Leão M, Migowski A, Araujo de Silva AR, Weiss C. Efficacy and Effectiveness Trials Have Different Goals, Use Different Tools, and Generate Different Messages. Pragmatic and Observational Research 2015;6:47-54 | ||
Porzsolt F. The assessments of three different dimensions “Efficacy”, “Effective-ness”, and “Value” require three different tools: the Randomized Controlled Trial (RCT), the Pragmatic Controlled Trial (PCT), and the Complete Economic or Cost-Effectiveness Analysis (CEA). Surg Rehabil, 2018;2(4):1. doi: 10.15761/SRJ.1000145 | ||
Schmaling K, Kaplan RM, Porzsolt F. Efficacy and effectiveness studies of depression are not well-differentiated in the literature: a systematic review. BMJ Evid Based Med. 2020 Mar 18. pii: bmjebm-2020-111337. doi:10.1136/bmjebm-2020-111337. | ||
Porzsolt F, Weiss Ch, Weiss M, Jauch K-W, Kaplan RM. Demystification – a Solution for Assessment of Real World Effectiveness? Trends Med 2020;20:1-2 doi: 10.15761/TiM.1000231 | ||
Porzsolt F, Wiedemann F, Phlippen M, Weiss C, Weiss M, Schmaling K, Kaplan RM. The terminology conflict on efficacy and effectiveness in healthcare. J Comp Eff Res. 2020;9:1171-1178. doi: 10.2217/cer-2020-0149435 | ||
"Porzsolt F, Weiss Ch, Weiss M. Covid-19: Twinmethode zum Nachweis der Real-World Effectiveness unter Alltagsbedingungen [Covid-19: Twin method for demonstration of real-world effectiveness (RWE) under the conditions of day-to-day care]. Das Gesundheitswesen 2022;84:1-4. DOI: 10.1055/a-1819-6237 ISSN 0941-3790" | ||
Porzsolt F. Kroemer R, Silva-Sobrinho RA. The two sides of the value medal – confirmed or not confirmed by Real-Word Effectiveness? VBHC Thinker Magazine Christmas Edition Dec. 2022: 40-43. | ||
Porzsolt F. Comparative effectiveness is the common denominator in health services research: Experimental effects are promising, real-world effects are compelling. J Comp Med Res 2023; in press | Siehe auch Text unten: "Die vergleichende Wirksamkeit ist der gemeinsame Nenner der Forschung im Gesundheitswe-sen: | |
Form Follows Function
| Porzsolt F. Form Follows Funktion: An der Schnittstelle zwischen Design und Klinischer Ökonomik. KrV Kranken- und Pflegeversicherung 2010;1:15-18 | https://www.krvdigital.de/KRV.01.2010.015351 |
Porzsolt F, Eisemann M, Habs M, Wyer P. Form Follows Function: Pragmatic Controlled Trials (PCTs) have to answer different questions and require different designs than Randomized Controlled Trials (RCTs). J Publ Health 2013;21:307-313. DOI 10.1007/s10389 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3655212/ | ||
Porzsolt F, Gonçalves CA, Mayer PCM. Interprofessional approach for Development of Evidence-based Medicine: Merging the Designer Rule Form Follows Function with the Epidemiological Questions: Can it work? Does it work? Is it worth it? BMC Med Res Methodol 2022: Submitted for publication June 4th, 2022 | ||
Goal of treatment
| Porzsolt F, Meuret G. Is Non-Symptomatic Stable Disease a Relevant Goal for Treatment of Metastatic Breast Cancer? Onkologie 1992;15:25-30. | |
Porzsolt F, Tannock I. Goals of palliative cancer therapy. J. Clin. Oncol. 1993;11:378-381. | ||
Porzsolt F. Goals of palliative cancer therapy: scope of the problem. Cancer Treatment Reviews 1993;19, Suppl. A:3-14117 | https://www.sciencedirect.com/science/article/pii/030573729390052S | |
Prümmer O, Porzsolt F, and the Delta-P Study Group. Recombinant IFN-a2 Antibodies in Renal Cell Carcinoma. J. Interferon Research 1994;14:193-195. | ||
Porzsolt F. Goals of palliative cancer therapy II (Reisensburg, 13.-16.3.1995). AIO - Arbeitsgemeinschaft Internistische Onkologie in der Deutschen Krebsgesellschaft e.V. - DKG. Jahresbericht 1995, pp 3-6 | ||
Porzsolt F, Wirth A, Mayer-Steinacker R, Schulte M, Negri G, Suhr P, Link KH, Gaus W, Röttinger EM. Quality assurance by specification and achievement of goals in palliative cancer treatment. Cancer Treatment Reviews 1996;22:41-50380 | https://www.sciencedirect.com/science/article/pii/S0305737296900626 | |
Quality of Life
| Sigle JM, Porzsolt, F. Practical aspects of quality of life measurement: Design and feasibility study of the Quality-of-Life-Recorder and the standardized measurement of quality of life in an outpatient clinic. Cancer Treatment Reviews 1996;22:75-90. | https://www.cancertreatmentreviews.com/article/S0305-7372(96)90067-5/pdf |
Porzsolt F, Wölpl C, Rist CE, Kosa R, Büchele G, Gaus W. Comparison of three instruments (QLQ-C30, SF-36, QWB-7) measuring health-related quality of life / quality of well being. Psycho-Oncology 1996;5:103-117. DOI 10.1002/(SICI)1099-1611(199606)5:2<103::AID-PON221>3.0.CO;2-W | ||
Coates A, Porzsolt F, Osoba D for the Internationale Gruppe Lebensqualität in der Onkologie (IGLOO). Quality of life in oncology practice: prognostic value of EORTC QLQ-C30 scores in patients with advanced malignancy. Eur. J. Cancer: 1997;33(7):1025-1030239 | https://www.sciencedirect.com/science/article/pii/S095980499700049X | |
Porzsolt F, Kojer M, Schmidl M, Greimel ER, Siegle J, Richter J and Eisemann M: A new instrument to describe indicators of well-being in old-old patients with severe dementia - The Vienna List. Health and Quality of Life Outcomes 2004, 2:10 (19 Feb 2004) | https://link.springer.com/chapter/10.1007/978-0-387-33921-4_8 | |
Koensgen D, Oskay-Oezcelik G, Katsares I, Walle U, Klapp C, Mustea A, Stengel D, Porzsolt F, Lichtenegger W, Sehouli J; on behalf of the Nord-Ostdeutschen Gesellschaft für Gynäkologische Onkologie (NOGGO) working group “Quality of life”. Development of the Berlin Symptom Checklist Ovary (BSCL-O) for the measurement of quality of life of patients with primary and recurrent ovarian cancer: results of a phase I and II study. Support Care Cancer. 2010; [Epub ahead of print]PMID: 19760286 [PubMed - as supplied by publisher] | ||
Porzsolt F, Clouth J, Deutschmann M, Hippler H-J. Preferences of diabetes patients and physicians: A feasibility study to identify the key indicators for appraisal of health care values. Health and Quality of Life Outcomes 2010, 8:125 doi:10.1186/1477-7525-8-125 | https://hqlo.biomedcentral.com/articles/10.1186/1477-7525-8-125 | |
Wiedemann F, Porzsolt F. The Terminology Conflict on Efficacy and Effectiveness in Clinical Trials on Health-Related Quality of Life. Research Square. 2021. DOI: https://doi.org/10.21203/rs.3.rs-148872/v1 | ||
Porzsolt F, Pfuhl G, Kaplan RM, Eisemann M. Covid-19 pandemic lessons: Uncritical communication of test results can induce more harm than benefit and raises questions on standardized quality criteria for communication and liability. Health Psychology and Behavioral Medicine 2021;9:818-829. DOI 10.1080/21642850.2021.1979407 | https://www.tandfonline.com/doi/full/10.1080/21642850.2021.1979407 | |
Wiedemann F, Porzsolt F. Measuring Health-Related Quality of Life in Randomised Controlled Trials: Expected and Reported Results Do Not Match. Pragmat. Obs. Res. 2022 Apr. 11;13:9-16. Doi 10.2147/POR.S350165. PMID: 35431592; PMCID9012498 | ||
Terminology
| Porzsolt F, Göttler S, Leonhardt-Huober H, Ohletz A, Sellenthin Ch, Sigle, JM, Sponholz G, Thim A, Baitsch H. Evidence-Based Medicine in der Inneren Medizin. Terminologie, Ziel, Konzept, Implementierung und Perspektive. Internistische Praxis 2001;41(3):463-478 | https://docplayer.org/5704376-Forum-fuer-evidence-based-medicine-und-evidence-based-health-care.html |
Porzsolt F, Wiedemann F, Schmaling K, Kaplan RM. The risk of imprecise terminology: incongruent results of clinical recommendations in clinical trials and incongruent recommendations in clinical guidelines. 10.1136/bmjebm 2019;24(Suppl 1):A17-A18 | ||
Schmaling K, Kaplan RM, Porzsolt F. Efficacy and effectiveness studies of depression are not well-differentiated in the literature: a systematic review. BMJ Evid Based Med. 2020 Mar 18. pii: bmjebm-2020-111337. doi:10.1136/bmjebm-2020-111337. | ||
Porzsolt F, Wiedemann F, Phlippen M, Weiss C, Weiss M, Schmaling K, Kaplan RM. The terminology conflict on efficacy and effectiveness in healthcare. J Comp Eff Res. 2020;9:1171-1178. doi: 10.2217/cer-2020-0149 | ||
Progress in Evidence-Based Medicine by critical appraisal of Evidence-Based Medicine:
The HOST Catalogue - Concordance of study Hypothesis, Objective, Statistics and Translation
Dissertation zur Erlangung des Doktorgrades der Medizin der medizinischen Fakultät der Universität Ulm
Meret Sophie Phlippen, Berlin 2020
1.1 The history of the randomized controlled trial
The Randomized Controlled Trial (RCT) is the current gold standard of clinical trials for comparing a treatment to a control. It was first performed for medical research in 1948 by Austin Bradford Hill testing the “Streptomycin treatment of pulmonary tuberculosis” [27, page 4582]. The original idea came from Sir Ronald Aylmer Fisher demonstrating it by the Lady Tasting Tea Experiment [12]. Since then randomization and the correct statistical analysis of study groups were recommended for the conduct of a clinical trial [4]. It is thought to equalize patient’s characteristics as much as possible [4].
Over the time, critical voices have been raised [1; 23; 42]. It became clear that RCTs are not always of necessity the best study design [7; 34] and should be handled with care [22; 43]: Forms of bias were observed [22; 40] and a lack of attention for methodologic and statistical standards [42].
In the mid-1990s, the new idea of the Evidence Based Medicine (EBM) could no longer be ignored [10; 38]. Antiquated medical routines dominated the daily clinical practice due to a lack of applying discoveries in research. EBM’s aim to ensure the best available treatment of a patient ought to be accomplished by utilizing the most recent, critically inspected, findings in research [36]. In addition, Consolidated Standards Of Reporting Trials (CONSORT) was launched to develop guidelines aimed for the best possible reporting in RCTs [41]. To this day, researchers and research groups are working on improvements of the best available study design. EBM still is a form of guideline for the best clinical practice and teaching. It has its benefits, but also negative consequences, such as a misuse by the industry or the limited applicability for multimorbid patients [15]. It was also shown that the influence of commercialization is one of the main reasons for a decrease in the quality of RCTs. The sponsoring of studies often has a negative effect on the outcome and increases bias [13; 14]. An example is the antidiabetic drug rosiglitazone. Its side effect of increased risk of myocardial infarction was swept under the carpet to possibly generate a better sales volume [46]. Another example is the controversy with calcium-channel antagonists supported by physicians and pharmaceutical industry and its doubtful safety [44]. One decade later almost identical critical comments were published in the literature [9, 16, 17 The most newsworthy movement, at the moment, is coming from the Centre for evidencebased medicine (EBM) in Oxford. They detected inconsistencies in trials [24] and now aim to find a way to implement “the best available research evidence to clinical practice integrating the values of patients” [18]. A series by the Journal of Clinical Epidemiology highlights a different study design: the pragmatic trial. It can be seen as an addition to the RCT, without replacing it. It serves with extra information, should be considered as an equal partner to RCTs and completes the missing information. Pragmatic trials “evaluate relative effectiveness under conditions routinely encountered in clinical practice...” [29, p.13], whereas clinical trials “deliver data onefficacy and safety of treatments, yet often insufficiently inform physicians, policy makers,
and other stakeholders how treatments will actually perform in real-world clinical practice.” [29, p.13]. Recently it was stated in the British Journal of Cancer: “Many reports of health research
omit important information needed to assess their methodological robustness and clinical relevance. Without clear and complete reporting, it is not possible to identify flaws or bi-
ases to reproduce successful interventions or use the findings in systematic reviews and meta-analysis.” [26, p.619] It is obvious that the conduct of an RCT needs clear rules: all of these above publications refer to a lack of quality of reporting. This lack may be related to methodologic standards, different forms of bias, such as commercialization or direct sponsoring. However, specific
solutions to improve the quality were rarely recommended.
Read the full dissertation here:
Die vergleichende Wirksamkeit ist der gemeinsame Nenner der Forschung im Gesundheitswe-sen:
Experimentelle Effekte sind vielversprechend, Effekte in der realen Welt sind überzeugend.
(Franz Porzsolt Institute of Clinical Economics, ICE e.V., 89081 Ulm / Germany.)
Die Debatte über die Berechtigung verschiedener Behandlungsmethoden wie schulmedizinischer, komplementärer und integrativer Methoden wird in Deutschland seit mehr als 100 Jahren geführt. Die inzwischen erzielten Fortschritte bei der Messung und Interpretation der erzielten Wirkungen ermöglichen vergleichende Studien über die Alltagstauglichkeit dieser Methoden.
Generell besteht ein gesteigertes Interesse an vergleichender Wirksamkeitsforschung, denn die verfügbaren Daten bestätigen die konstante Nachfrage nach komplementären und integrativen Methoden als Ergänzung zur oder anstelle der Schulmedizin. Die Beständigkeit dieser Nachfrage rechtfertigt die Annahme, dass verschiedene Gesundheitsprobleme durch unterschiedliche Methoden und mit unterschiedlicher Effizienz gelindert oder geheilt werden können. Ohne die Bestätigung dieser Erfolge wäre es schwierig, deren Finanzierung rational zu rechtfertigen. Es sollte nicht schwierig sein, Gesundheitsprobleme zu identifizieren, die sich für vergleichende Analysen verschiedener Methoden eignen.
Das Ziel dieses Kommentars ist es, die Kontroverse in einen Erkenntnisgewinn für alle Beteiligten umzuwandeln. Es werden die Überlegungen, die Strategie und die Methoden beschrieben, die dafür erforderlich sind
Pragmatic Controlled Trials
Unsere aktuelle Diskussion prüft die Belastbarkeit der Hypothese, dass es in ca. 5 Jahren kaum noch randomisierte kontrollierte Studien (RCTs) geben wird, da diese die Versorgungsrealität nicht ausreichend abbilden.Stattdessen stehen inzwischen nicht-experimentelle Studiendesigns zur Verfügung, z.B. das Pragmatic Controlled Trial. Die Mitglieder des ICE sind eingeladen, sich an der Diskussion dieser Hypothese zu beteiligen (Externer Link).
Perceived Safety / Gefühlte Sicherheit
Unsere aktuelle Diskussion behandelt den Zusammenhang von objektiven Risiken und deren subjektiver Wahrnehmung, die wir als „Gefühlte Sicherheit“ bezeichnen. Das Verständnis des Zusammenhangs zwischen objektivem Risiko und der subjektiv wahrgenommenen Sicherheit sollte in der Öffentlichkeit diskutiert werden. Die Gesellschaft muss die Fähigkeit erwarben, glaubwürde Aussagen von fragwürdigen Aussagen zu unterscheiden.
Diese Forderung gilt nicht nur für die Gesundheitsversorgung. Sie ist auf alle Lebensbereiche anwendbar.
 | Veröffentlichungen veroeffentlichungen_122022.pdf (108.39KB) |
| veroeffentlichungen_122022.pdf (108.39KB) |