%0 Journal Article %1 Dreyer2011 %A Dreyer, Nancy A %D 2011 %J Epidemiology (Cambridge, Mass.) %K ComparativeEffectivenessResearch ComparativeEffectivenessResearch:methods ComparativeEffectivenessResearch:trends DecisionSupportSystems Female Forecasting Humans Male Management Management:trends Observation Observation:methods QualityImprovement UnitedStates RCT %N 3 %P 295-7 %R 10.1097/EDE.0b013e3182126569 %T Making observational studies count: shaping the future of comparative effectiveness research. %U http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=ovftl&AN=00001648-201105000-00005 http://www.ncbi.nlm.nih.gov/pubmed/21464648 %V 22 %X References: 1. Food and Drug Administration Amendments Act of 2007. HR 3580. Available at: http://www.thomas.gov/cgi-bin/bdquery/z?d110:h.r.03580. Accessed 16 June 2010. 2. Conference Report on HR 1. American Recovery and Reinvestment Act of 2009. 111th Congress, First Session, Congressional Record House; 12 February 2009. 155:H1307-1516. 3. United States Senate. HR 3590. The Patient Protection and Affordability Care Act. Available at: http://democrats.senate.gov/reform/patient-protection-affordable-care-act-as-passed.pdf. Accessed 4 June 2010. 4. Available at: http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf. June 2009. Accessed 11 October 2009. 5. Dreyer NA, Tunis SR, Berger M, et al. Why observational studies should be among the tools used in comparative effectiveness research. Health Aff. 2010;29:1818-1825. 6. Adisasmito WA, Chan PK, Lee N, et al. Effectiveness of antiviral treatment in human influenza H5N1 infections: analyses from a global patient registry. J Infect Dis. 2010;202:1154-1160. 7. Steinbrook R. Saying no isn't NICE-the travails of Britain's National Institute for Health and Clinical Excellence. N Engl J Med. 2008;359:1977-1981. 8. Rothman KJ, Poole C. Some guidelines on guidelines: they should come with expiration dates. Epidemiology. 2007;18:794-796. 9. Vandenbroucke Jan P. STREGA, STROBE, STARD, SQUIRE, MOOSE, PRISMA, GNOSIS, TREND, ORION, COREQ, QUORUM, REMARK...and CONSORT: For whom does the guideline toll? J Clin Epidemiol. 2009;62:594-596. 10. European Medicines Agency. ICH topic E6 R1. Guideline for Good Clinical Practice. CPMP/ICH/135/95. Available at: http://www.ema.europa.eu/pdfs/human/ich/013595en.pdf. July 2002. 11. CONSORT Statement. JAMA. 2001;285:1987-1991. 12. Moher D, Liberati A, Tetzlaff J, Altman DG; The PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA Statement. Ann Intern Med. 2009;151:264-269. 13. Dreyer NA, Schneeweiss S, McNeil B, et al. Recognizing high-quality observational studies of comparative effectiveness. Am J Manag Care. 2010;16:467-471. 14. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Available at: www.encepp.eu. 15. Berger ML, Mamdani M, Atkins D, Johnson ML. Good research practices for comparative effectiveness research: defining, reporting, and interpreting nonrandomized studies of treatment effects using secondary data sources: The ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report-Part I. Value Health. 2009;12:1044-1061. 16. Cox E, Martin BC, Van Staa T, Garbe E, Siebert U, Johnson ML. Good research practices for comparative effectiveness research: approached to mitigate bias and confounding in the design of nonrandomized studies of treatment effects using secondary sources: The International Society for Pharmacoeconomics and Outcome Research Good Research Practices for Retrospective Analysis Task Force Report-Part II. Value Health. 2009;12:1053-1061. 17. Johnson ML, Crown W, Martin BC, Dormuth CR, Siebert U. Good research practices for comparative effectiveness research: analytic methods to improve causal inference from nonrandomized studies of treatment effects using secondary data sources: The ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report-Part III. Value Health. 2009;12:1062-1072. 18. Von Elm E, Altman DG, Egger M, Pocock SJ, Gotzche PC, Vandenbroucke JP. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: Guidelines for reporting observational studies. Ann Intern Med. 2007;147:573-577. 19. GRACE Principles-Good ReseArch for Comparative Effectiveness. Available at: www.graceprinciples.org. 20. ENCePP Guide on Methodological Standards in Pharmacoepidemiology. EMA/95098/2010. Available at: www.encepp.eu. 21. Vandenbroucke JP. Preregistration of Epidemiologic Studies: An ill-founded mix of ideas. Epidemiology. 2010;21:619-620. 22. Poole C. A vision of accessible epidemiology. Epidemiology. 2010;21:616-618. 23. Lash TL. Preregistration of study protocols is unlikely to improve the yield from our science, but other strategies might. Epidemiology. 2010;21:612-613. %@ 1044-3983

@article{Dreyer2011, abstract = {References: 1. Food and Drug Administration Amendments Act of 2007. HR 3580. Available at: http://www.thomas.gov/cgi-bin/bdquery/z?d110:h.r.03580. Accessed 16 June 2010. 2. Conference Report on HR 1. American Recovery and Reinvestment Act of 2009. 111th Congress, First Session, Congressional Record House; 12 February 2009. 155:H1307-1516. 3. United States Senate. HR 3590. The Patient Protection and Affordability Care Act. Available at: http://democrats.senate.gov/reform/patient-protection-affordable-care-act-as-passed.pdf. Accessed 4 June 2010. 4. Available at: http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf. June 2009. Accessed 11 October 2009. 5. Dreyer NA, Tunis SR, Berger M, et al. Why observational studies should be among the tools used in comparative effectiveness research. Health Aff. 2010;29:1818-1825. 6. Adisasmito WA, Chan PK, Lee N, et al. Effectiveness of antiviral treatment in human influenza H5N1 infections: analyses from a global patient registry. J Infect Dis. 2010;202:1154-1160. 7. Steinbrook R. Saying no isn't NICE-the travails of Britain's National Institute for Health and Clinical Excellence. N Engl J Med. 2008;359:1977-1981. 8. Rothman KJ, Poole C. Some guidelines on guidelines: they should come with expiration dates. Epidemiology. 2007;18:794-796. 9. Vandenbroucke Jan P. STREGA, STROBE, STARD, SQUIRE, MOOSE, PRISMA, GNOSIS, TREND, ORION, COREQ, QUORUM, REMARK...and CONSORT: For whom does the guideline toll? J Clin Epidemiol. 2009;62:594-596. 10. European Medicines Agency. ICH topic E6 R1. Guideline for Good Clinical Practice. CPMP/ICH/135/95. Available at: http://www.ema.europa.eu/pdfs/human/ich/013595en.pdf. July 2002. 11. CONSORT Statement. JAMA. 2001;285:1987-1991. 12. Moher D, Liberati A, Tetzlaff J, Altman DG; The PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA Statement. Ann Intern Med. 2009;151:264-269. 13. Dreyer NA, Schneeweiss S, McNeil B, et al. Recognizing high-quality observational studies of comparative effectiveness. Am J Manag Care. 2010;16:467-471. 14. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Available at: www.encepp.eu. 15. Berger ML, Mamdani M, Atkins D, Johnson ML. Good research practices for comparative effectiveness research: defining, reporting, and interpreting nonrandomized studies of treatment effects using secondary data sources: The ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report-Part I. Value Health. 2009;12:1044-1061. 16. Cox E, Martin BC, Van Staa T, Garbe E, Siebert U, Johnson ML. Good research practices for comparative effectiveness research: approached to mitigate bias and confounding in the design of nonrandomized studies of treatment effects using secondary sources: The International Society for Pharmacoeconomics and Outcome Research Good Research Practices for Retrospective Analysis Task Force Report-Part II. Value Health. 2009;12:1053-1061. 17. Johnson ML, Crown W, Martin BC, Dormuth CR, Siebert U. Good research practices for comparative effectiveness research: analytic methods to improve causal inference from nonrandomized studies of treatment effects using secondary data sources: The ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report-Part III. Value Health. 2009;12:1062-1072. 18. Von Elm E, Altman DG, Egger M, Pocock SJ, Gotzche PC, Vandenbroucke JP. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: Guidelines for reporting observational studies. Ann Intern Med. 2007;147:573-577. 19. GRACE Principles-Good ReseArch for Comparative Effectiveness. Available at: www.graceprinciples.org. 20. ENCePP Guide on Methodological Standards in Pharmacoepidemiology. EMA/95098/2010. Available at: www.encepp.eu. 21. Vandenbroucke JP. Preregistration of Epidemiologic Studies: An ill-founded mix of ideas. Epidemiology. 2010;21:619-620. 22. Poole C. A vision of accessible epidemiology. Epidemiology. 2010;21:616-618. 23. Lash TL. Preregistration of study protocols is unlikely to improve the yield from our science, but other strategies might. Epidemiology. 2010;21:612-613.}, added-at = {2023-02-03T11:44:35.000+0100}, author = {Dreyer, Nancy A}, biburl = {https://www.bibsonomy.org/bibtex/2b8da7cdf35215a1232f95f5206eccac2/jepcastel}, city = {From Outcome Sciences Inc., Cambridge, MA.}, doi = {10.1097/EDE.0b013e3182126569}, interhash = {71c4ad0c298b9f7bbba482b7bbdfbe69}, intrahash = {b8da7cdf35215a1232f95f5206eccac2}, isbn = {1044-3983}, issn = {1531-5487}, journal = {Epidemiology (Cambridge, Mass.)}, keywords = {ComparativeEffectivenessResearch ComparativeEffectivenessResearch:methods ComparativeEffectivenessResearch:trends DecisionSupportSystems Female Forecasting Humans Male Management Management:trends Observation Observation:methods QualityImprovement UnitedStates RCT}, month = {5}, note = {6102<m:linebreak></m:linebreak>[Miscellaneous]; NLM Journal Code: a2t, 9009644;<m:linebreak></m:linebreak>CER}, number = 3, pages = {295-7}, pmid = {21464648}, timestamp = {2023-05-04T08:59:38.000+0200}, title = {Making observational studies count: shaping the future of comparative effectiveness research.}, url = {http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=ovftl&AN=00001648-201105000-00005 http://www.ncbi.nlm.nih.gov/pubmed/21464648}, volume = 22, year = 2011 }