Real World Data Guidelines - Current Status Review

• Autorzy: Monika Szkultecka-Dębek , Mariola Drozd
• Języki publikacji: EN

Abstrakty

EN

Based on the performed search we have obtained in total 97661 records. After analysis and selection we finally identified 40 publications fitting our search criteria and we found that only 2 were dedicated to RWD and provided some guidelines to researchers. The published guidelines are usually focused on specific type of RWD studies and there are not many guidelines available in relation to real world data methodology research in general. In view of the potential use of RWD in decision making specific guidelines on how to conduct RWD research are needed(original abstract)

Słowa kluczowe

EN

Medical data; Research methodology; Databases

PL

Dane medyczne; Metodologia badań; Bazy danych

• Czasopismo: Journal of Health Policy and Outcomes Research
• Rocznik: 2015
• Numer: nr 1
• Strony: 10--14

Twórcy

autor

Monika Szkultecka-Dębek

• Roche Polska Sp. z o.o.

autor

Mariola Drozd

• Medical University of Lublin, Poland

Bibliografia

• Drozd M., Szkultecka-Dębek M.: Do we need real world data? Polish ISPOR Chapter Therapeutic Programs, Pharmaceutical Care and Pharmaceutical Law Section (TPPCPL) initial discussion; JHPOR 2014, 2
• Hay J.: Health care costs and outcomes: how should we evaluate real world data? Value Health. 1999 Nov-Dec; 2(6): 417-9
• Garrison LP. Jr, Neumann PJ., Erickson P., Marshall D., Mullins CD.: Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report. Value Health. 2007 Sep-Oct; 10(5): 326-35
• Willke RJ., Mullins CD.: Ten commandments" for conducting comparative effectiveness research using "real-world data". Supplement to Journal of Managed Care Pharmacy JMCP November/December 2011 Vol. 17, No. 9-a
• Roche N., Reddel H., Martin R., Brusselle G., Papi A., Thomas M., Postma D., Thomas V., Rand C., Chisholm A., Price D., Respiratory Effectiveness Group: Quality standards for real-world research. Focus on observational database studies of comparative effectiveness. Ann. Am. Thorac. Soc. 2014 Feb; 11 Suppl 2: S99-104; doi: 10.1513/AnnalsATS.201309-300RM
• von Elm E., Altman DG., Egger M., Pocock SJ., Gøtzsche PC., Vandenbroucke JP.: Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies BMJ. 2007 Oct 20; 335(7624): 806-808; doi: 10.1136/bmj.39335.541782.AD
• Minowa E., Piedade A., Julian G.: Real World data for Health and Technology assessment in Brazil: an unmet need Value In Health 18 (2015) A1-A307 - PHP88
• Faria R., Hernandez Alava M., Manca A., Wailoo A.J. NICE DSU technical support document 17: The use of observational data to inform estimates of treatment effectiveness in technology appraisal: Methods for comparative individual patient data. Report by the decision support unit May 2015; ​Available from: http://www.nicedsu.org.uk/TSD17%20-%20DSU%20Observational%20data%20FINAL.pdf

Identyfikatory

DOI

10.7365 / JHPOR.2015.1.2