scholarly journals Manual für Methoden und Nutzung versorgungsnaher Daten zur Wissensgenerierung

2020 ◽  
Vol 82 (08/09) ◽  
pp. 716-722
Author(s):  
Monika Klinkhammer-Schalke ◽  
Thomas Kaiser ◽  
Christian Apfelbacher ◽  
Stefan Benz ◽  
Karsten E. Dreinhöfer ◽  
...  
Keyword(s):  
Real World ◽  
Best Practice ◽  
Ad Hoc ◽  
Real Word ◽  
Real World Evidence ◽  
Vergleichende Studien

ZusammenfassungFür die Nutzung vorhandener Versorgungsdaten gibt es immer mehr gute Gründe, wobei v. a. die Nutzung von Registerdaten im Fokus steht. Das zugehörige, klar strukturierte methodische Vorgehen ist bisher noch unzureichend zusammengeführt, aufbereitet und transparent dargestellt. Das Deutsche Netzwerk Versorgungsforschung (DNVF) hat deswegen eine Ad hoc Kommission zur Nutzung versorgungsnaher Daten (RWE/RWD) ins Leben gerufen. Der vom IQWiG erstellte Rapid Report über die wissenschaftliche Ausarbeitung von Konzepten zur „Generierung versorgungsnaher Daten und deren Auswertung zum Zwecke der Nutzenbewertung von Arzneimitteln nach § 35a SGB V“ ist ein wesentlicher Schritt für die Nutzung von Registerdaten zur Evidenzgenerierung. Das vom DNVF 2020 veröffentlichte „Memorandum Register – Update 2019“ beschreibt Anforderungen und methodische Grundlagen von Registern. Best Practice Beispiele aus der Onkologie, die auf dem einheitlichen onkologischen Basisdatensatz für die Klinische Krebsregistrierung (§ 65c SGB V) beruhen, zeigen z. B., dass im Sinne einer wissensgenerierenden Versorgungsforschung mithilfe von Registerdaten Leitlinien überprüft sowie Empfehlungen für Leitlinien und notwendige Interventionen abgeleitet werden können. Gleichzeitig fehlen jedoch klare Qualitätsanforderungen und strukturierte formale und inhaltliche Vorgehensweisen in den Bereichen Datenzusammenführung, Datenprüfung und Nutzung spezifischer Methoden je nach vorhandener Fragestellung. Die bisher uneinheitlichen Vorgaben sollen aufgearbeitet und ein Methoden-Leitfaden zur Nutzung versorgungsnaher Daten entwickelt und veröffentlicht werden. Das erste Kapitel des Manuals zu Methoden versorgungsnaher Daten erläutert Zielstellung und Struktur des Manuals. Es wird dargelegt, warum die Verwendung des Begriffes „Versorgungsnahe Daten (VeDa)“ zielführender ist als die Nutzung der Begriffe Real Word Data (RWD) und Real World Evidence (RWE). Mit der Vermeidung des Begriffes „Real World“ soll insbesondere unterstrichen werden, dass auch qualitativ hochwertige Forschung auf Versorgungsdaten aufsetzen kann (z. B. registerbasierte vergleichende Studien).

The AWARE Study: Methodology and Baseline Characteristics

2009 ◽  
Vol 13 (6_suppl) ◽  
pp. S113-S121 ◽  
Author(s):  
Robert Bissonnette ◽  
Gordon Searles ◽  
Ian Landells ◽  
Neil H. Shear ◽  
Kim Papp ◽  
...  
Keyword(s):  
Disease Control ◽  
Real World ◽  
Plaque Psoriasis ◽  
Best Practice ◽  
Treatment Plan ◽  
Demographic Data ◽  
Clinical Practices ◽  
Chronic Plaque Psoriasis ◽  
Real World Evidence ◽  
Patient Demographic Data

Background: Alefacept was the first biologic therapy approved by Health Canada for the treatment of moderate to severe chronic plaque psoriasis and is used either alone or as part of combination therapy. Objective: AWARE (Amevive Wisdom Acquired from Real-World Evidence) is a multicenter, observational phase IV Canadian study of psoriasis patients treated with alefacept. This study's main goals were to develop a shared, real-time, national clinical database to support best practice and optimize the care of patients receiving alefacept and to gain an understanding of how alefacept is used in Canadian clinical practice. Baseline patient demographic data are described herein. Methods: Patients with chronic plaque psoriasis were enrolled from 37 clinics across Canada. Subjects received at least one course of alefacept treatment followed by a period of at least 12 weeks off treatment and were prospectively followed for at least 60 weeks. Baseline assessments included patient demographics, relevant medical history, psoriasis and treatment history, reasons for initiating alefacept, enrolling physician's initial alefacept treatment plan and strategy, percent body surface area (BSA) involvement with psoriasis, and physician's baseline assessment of disease control. Subsequent assessments at each follow-up visit included the patient's response and the physician's assessment. Results: A total of 426 adult patients with predominantly chronic plaque psoriasis, with or without other types of psoriasis, were enrolled into the AWARE registry. Patients generally had moderate to severe psoriasis, with more than half (55.8%) having little or no disease control at baseline as assessed by their clinician, and 77% had > 10% BSA involvement with psoriasis. All patients in the AWARE patient population were receiving one or more treatments for psoriasis prior to or at the time of enrolment, and the majority continued to receive concomitant treatments at the time of study enrolment. Conclusion: The AWARE registry enrolled a broad group of real-world patients with chronic plaque psoriasis treated with alefacept in clinical practices across Canada.

scholarly journals Real-world evidence use in assessments of cancer drugs by NICE

2020 ◽  
Vol 36 (4) ◽  
pp. 388-394 ◽  
Author(s):  
Ash Bullement ◽  
Tanja Podkonjak ◽  
Mark J. Robinson ◽  
Eugene Benson ◽  
Ross Selby ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Real World ◽  
Best Practice ◽  
Cost Effectiveness Analysis ◽  
Cancer Drug ◽  
Cancer Drugs ◽  
Best Practice Guidelines ◽  
Effectiveness Analysis ◽  
Real World Evidence ◽  
Related Quality

ObjectiveTo establish how real-world evidence (RWE) has been used to inform single technology appraisals (STAs) of cancer drugs conducted by the National Institute for Health and Care Excellence (NICE).MethodsSTAs published by NICE from April 2011 to October 2018 that evaluated cancer treatments were reviewed. Information regarding the use of RWE to directly inform the company-submitted cost-effectiveness analysis was extracted and categorized by topic. Summary statistics were used to describe emergent themes, and a narrative summary was provided for key case studies.ResultsMaterials for a total of 113 relevant STAs were identified and analyzed, of which nearly all (96 percent) included some form of RWE within the company-submitted cost-effectiveness analysis. The most common categories of RWE use concerned the health-related quality of life of patients (71 percent), costs (46 percent), and medical resource utilization (40 percent). While sources of RWE were routinely criticized as part of the appraisal process, we identified only two cases where the use of RWE was overtly rejected; hence, in the majority of cases, RWE was accepted in cancer drug submissions to NICE.DiscussionRWE has been used extensively in cancer submissions to NICE. Key criticisms of RWE in submissions to NICE are seldom regarding the use of RWE in general; instead, these are typically concerned with specific data sources and the applicability of these to the decision problem. Within an appropriate context, RWE constitutes an extremely valuable source of information to inform decision making; yet the development of best practice guidelines may improve current reporting standards.

1243-P: Novel Use of Natural Language Processing to Identify Reasons for Insulin Discontinuation in Patients with T2DM: A Real-World Evidence Study

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 1243-P
Author(s):  
JIANMIN WU ◽  
FRITHA J. MORRISON ◽  
ZHENXIANG ZHAO ◽  
XUANYAO HE ◽  
MARIA SHUBINA ◽  
...  
Keyword(s):  
Natural Language Processing ◽  
Natural Language ◽  
Language Processing ◽  
Real World ◽  
Real World Evidence

381-P: Real-World Evidence that Impaired Awareness of Hypoglycemia Increases Severe Hypoglycemia Rates in T2DM (InHypo-DM Study)

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 381-P
Author(s):  
ALEXANDRIA RATZKI-LEEWING ◽  
STEWART B. HARRIS ◽  
NATALIE H. AU ◽  
SUSAN WEBSTER-BOGAERT ◽  
JUDITH B. BROWN ◽  
...  
Keyword(s):  
Real World ◽  
Severe Hypoglycemia ◽  
Real World Evidence ◽  
Impaired Awareness

1607-P: Real-World Evidence of the Impact of Obesity on Residual Teeth in the Japanese Population

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 1607-P
Author(s):  
MAYU HAYASHI ◽  
KATSUTARO MORINO ◽  
KAYO HARADA ◽  
MIKI ISHIKAWA ◽  
ITSUKO MIYAZAWA ◽  
...  
Keyword(s):  
Real World ◽  
Japanese Population ◽  
Real World Evidence ◽  
The Impact
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