Preview

The Scientific Notes of the Pavlov University

Advanced search

CLINICAL TRIAL RESULS AND REAL WORLD MEDICAL EVIDENCE GAP

https://doi.org/10.24884/1607-4181-2018-25-1-7-14

Abstract

This is a systematic literature overview concerning contemporary approaches to the gap between randomized clinical trials (RCT) results and the evidence within real world medical practice («efficacy-effectiveness gap, EEG»). The overview includes 18 articles and 1 publication by regulatory expert community. 13 articles describe the EEG using particular evidence and 5 articles discuss the issue systematically. According to the results of the observations, the authors of 16 articles concluded that this discrepancy exists, and the authors of 2 articles concluded that in their studies this discrepancy was not found. Upon current review it was concluded that the factors providing EEG can be divided into the following groups: subjective factors coming from healthcare system organization processes and the caregiver-patient intercommunication principles; objective factors coming from essential RCT limitations as a scientific method; and the artificial limitations always made within RCT taking intermediate position.

About the Authors

A. V. Philippova
Federal State Budgetary Educational Institution of Higher Education «Pavlov First Saint Petersburg State Medical University» St. Petersburg
Russian Federation


A. S. Kolbin
Federal State Budgetary Educational Institution of Higher Education «Saint-Petersburg State University», St. Petersburg
Russian Federation


References

1. Cochrane A.L. Effectiveness and efficiency: random reflection on health services. London: Nuffield Provincial Hospitals Trust, 1972 [online]. URL: https://www.nuffieldtrust. org.uk/files/2017-01/effectiveness-and-efficiency-web-final. pdf (Дата обращения 23.09.2017). DOI: 10.1016/S0033- 3506(73)80082-4.

2. Haynes B. Can it work? Does it work? Is it worth it?: The testing of healthcare interventions is evolving. BMJ : British Medical Journal. 1999; 319 (7211): 652-653 [online]. URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1116525/ pdf/652.pdf (Дата обращения 23.09.2017). DOI: 10.1136/ bmj.319.7211.652.

3. High Level Pharmaceutical Forum 2005-2008. Final Conclusions and Recommendations of the Pharmaceutical Forum [online]. URL: http://www.bgpharma.bg/bulletin/ read/edition/8/file/final_conclusions_en.pdf (Дата обращения 23.09.2017);

4. Eichler H.G., Abadie E., Breckenridge A., et al. Bridging the efficacy-effectiveness gap: a regulator’s perspective on addressing variability of drug response. Nat Rev Drug Discov. 2011; 10(7):495-506 [online]. URL: https://www.ncbi.nlm. nih.gov/pubmed/21720406 (дата обращения 23.09.2017). DOI: 10.2147/CLEP.S121991.

5. Guscott R., Taylor L. Lithium prophylaxis in recurrent affective illness. Efficacy, effectiveness and efficiency. Br J Psychiatry. 1994;164(6):741-6 [online]. URL: https:// www.ncbi.nlm.nih.gov/pubmed/7952980 (дата обращения 23.09.2017). DOI: 10.1192/bjp.164.6.741.

6. Bauer M.S., McBride L., Shea N., et al. Impact of an easy-access VA clinic-based program for patients with bipolar disorder. Psychiatr Serv. 1997;48(4):491-6 [online]. URL: https://www.ncbi.nlm.nih.gov/pubmed/9090732 (дата обращения 23.09.2017). DOI: 10.1016/0006-3223(96)84045-5.

7. Bauer M.S., Williford W.O., Dawson E.E., et al. Principles of effectiveness trials and their im-plementation in VA Cooperative Study #430: ‘Reducing the efficacyeffectiveness gap in bipolar disorder’. J Affect Disord. 2001;67(1-3):61-78 [online]. URL: https://www.ncbi.nlm. nih.gov/pubmed/11869753 (дата обращения 23.09.2017). DOI: 10.1016/s0165-0327(01)00440-2.

8. Bauer M.S. The collaborative practice model for bipolar disorder: design and implementation in a multisite randomized controlled trial. Bipolar Disord. 2001; Oct;3(5):233-44 [online]. URL: https://www.ncbi.nlm.nih. gov/pubmed/11903206 (дата обращения 23.09.2017). DOI: 10.1034/j.1399-5618.2001.30502.x.

9. Scott J. Using Health Belief Models to understand the efficacy-effectiveness gap for mood stabilizer treatments. Neuropsychobiology. 2002; 46 Suppl 1:13-5 [online]. URL: https://www.ncbi.nlm.nih.gov/pubmed/12571427 (дата об- ращения 23.09.2017). DOI: 10.1159/000068022.

10. Colom F. Achieving remission and recovery in bipolar disorder. J Clin Psychiatry. 2010;71(11):e32 [online]. URL: https://www.ncbi.nlm.nih.gov/pubmed/21114945 (дата об- ращения 23.09.2017). DOI: 10.4088/jcp.9075tx2c.

11. Weiss A.P., Guidi J., Fava M. Closing the efficacyeffectiveness gap: translating both the what and the how from randomized controlled trials to clinical practice. J Clin Psychiatry. 2009;70(4):446-9 [online]. URL: https://www. ncbi.nlm.nih.gov/pubmed/19403096 (дата обращения 23.09. 2017). DOI: 10.4088/jcp.08com04901.

12. MacDonald K.M., Vancayzeele S., Deblander A., et al. Longitudinal observational studies to study the efficacy-effectiveness gap in drug therapy: application to mild and moderate dementia. Nurs Clin North Am. 2006;41(1):105-17, vii [online]. URL: https://www.ncbi.nlm.nih.gov/pubmed/16492457 (дата обращения 23.09.2017). DOI: 10.1016/j.cnur.2005.10.002.

13. Tandon R. Bridging the efficacy-effectiveness gap in the antipsychotic treatment of schizophrenia: back to the basics. J Clin Psychiatry. 2014;75(11):e1321-2 [online]. URL: https://www.ncbi.nlm.nih.gov/pubmed/25470099 (дата обра-щения 24.09.2017). DOI: 10.4088/jcp.14com09595.

14. Srikanthan A., Amir E. Efficacy-effectiveness gap as an obstacle to translating clinical trials to clinical practice. Eur J Cancer. 2015;51(8):905-6 [online]. URL: https://www. ncbi.nlm.nih.gov/pubmed/25857548 (дата обращения 24.09.2017). DOI: 10.1016/j.ejca.2015.03.017.

15. Thortzen A., Thim S., Røder M.A., et al. A single-center experience with abiraterone as treat-ment for metastatic castration-resistant prostate cancer. Urol Oncol. 2016; 34(7):291.e1-7 [online]. URL: https://www.ncbi.nlm.nih. gov/pubmed/26971191 (дата обращения 24.09.2017). DOI: 10.1016/j.urolonc.2016.02.013.

16. Schuller Y., Hollak C.E.M., Gispen-de Wied C.C., et al. Factors Contributing to the Efficacy-Effectiveness Gap in the Case of Orphan Drugs for Metabolic Diseases. Drugs. 2017 [online]. URL: https://www.ncbi.nlm.nih.gov/ pubmed/28752290 (дата обращения 24.09.2017). DOI: 10.1007/s40265-017-0788-z.

17. Jäger A., Amler N., Bierbaum M., et al. Quantifying The Efficacy-Effectiveness-Gap Using The Example of Metformin. Value Health. 2015;18(7):A618-9 [online]. URL: https://www.ncbi.nlm.nih.gov/pubmed/26533470 (дата об- ращения 24.09.2017). 10.1016/j.jval.2015.09.2161.

18. Ankarfeldt M.Z., Adalsteinsson E., Groenwold R.H., et al. A systematic literature review on the efficacy-effectiveness gap: comparison of randomized controlled trials and observational studies of glucose-lowering drugs. Clin Epidemiol. 2017;9:41-51 [online]. URL: https://www.ncbi. nlm. nih.gov/pubmed/28176959 (дата обращения 24.09.2017). DOI: 10.2147/clep.s121991.

19. Nordon C., Karcher H., Groenwold R.H., et al. The «Efficacy-Effectiveness Gap»: Historical Background and Current Conceptualization. Value Health. 2016;19(1):75- 81 [online]. URL: https://www.ncbi.nlm.nih.gov/pubmed/ 26797239 (дата обращения 24.09.2017). DOI: 10.1016/ j.jval.2015.09.2938.


Review

For citations:


Philippova A.V., Kolbin A.S. CLINICAL TRIAL RESULS AND REAL WORLD MEDICAL EVIDENCE GAP. The Scientific Notes of the Pavlov University. 2018;25(1):7-14. (In Russ.) https://doi.org/10.24884/1607-4181-2018-25-1-7-14

Views: 1328


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 1607-4181 (Print)
ISSN 2541-8807 (Online)