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2018, Number 1

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Gac Med Mex 2018; 154 (1)

Valoración de la calidad metodológica y ética de los ensayos clínicos publicados en revistas de medicina de familia (2010-2013)

Castaño-García A, Guillén-Grima F, León-Sanz P

Language: Spanish
References: 42
Page: 92-104
PDF size: 222.30 Kb.


ABSTRACT

Objective: To evaluate some methodological and ethical quality variables of clinical trials (CTs) published in 10 family medicine journals. Methods: Quality descriptive study of 10 family medicine journals including CTs in humans published since 2010 to 2013. We obtained 141 CT and 2447 were excluded. Results: CTs parallels controlled in 92.9% (95% confidence interval [95% CI]: 92.0-93.9). Masked randomization in 72.3% (95% CI: 71.7-73.1), decentralized in 51.8% (95% CI: 51.4-52.4) and using as control an active treatment in 82.2% (95% CI: 81.5-83.1). Wrote informed consent in 48.9% (95% CI: 48.5-49.5) and it was not withdrawn in 56.0% of cases (95% CI: 55.5-56.7). Approval by clinical research ethics committee (CREC) in 134, and there was no conflict of interest in 117 CTs. Average κ was 0.96 (95% CI: 0.93-0.99). Conclusions: We observe an increase in some quality variables like masked randomization (19.6%) and approval by CREC (75%) post CONSORT, in CTs published in 10 family medicine journals (2010-2013).


REFERENCES

  1. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336:924-6.

  2. Pildal J, Chan AW, Hrobjartsson A, et al. Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study. BMJ. 2005;330:1049-52.

  3. Moher D, Altman DG, Schulz KF, et al. Opportunities and challenges for improving the quality of reporting clinical research: CONSORT and beyond. CMAJ. 2004;171:349-50.

  4. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869.

  5. Dechartres A, Charles P, Hopewell S, Ravaud P, Altman DG. Reviews assessing the quality or the reporting of randomized controlled trials are increasing over time but raised questions about how quality is assessed.J Clin Epidemiol. 2011;64:136-44.

  6. Cui Q, Tian J, Song X, et al. Does the CONSORT checklist for abstracts improve the quality of reports of randomized controlled trials on clinical pathways? J Eval Clin Pract. 2014;20:827-33.

  7. Hopewell S, Dutton S, Yu LM, et al. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ. 2010;340:c723.

  8. Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ. 2004;328:702-8.

  9. Ahmed Ali U, van der Sluis PC, Issa Y, et al. Trends in worldwide volume and methodological quality of surgical randomized controlled trials. Ann Surg. 2013;258:199-207.

  10. Moher D, Liberati A, Tetzlaff J, et al.; The PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6:e1000097.

  11. ISI Web of Knowledge. Journal Citations Reports. Thomson Reuters; 2014. (Consultado el 4 de febrero de 2014.) Disponible en: http://admin- apps.webofknowledge.com/JCR/JCR

  12. Mills E, Wu P, Gagnier J, et al. The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement. Contemporary Clin Trials. 2005;26:480-7.

  13. Hooft L, Korevaar DA, Molenaar N, et al. Endorsement of ICMJE’s clinical trial registration policy: a survey among journal editors. Neth J Med. 2014;72:349-55.

  14. Millum J, Wendler D, Emanuel EJ. The 50th anniversary of the Declaration of Helsinki. Progress but many remaining challenges. JAMA. 2013;310:2143-4.

  15. Baskerville NB, Liddy C, Hogg W. Systematic review and meta-analysis of practice facilitation within primary care settings. Ann Fam Med. 2012;10:63-74.

  16. Bai Y, Gao J, Zou DW, Li ZS. Methodological reporting of randomized clinical trials in major gastroenterology and hepatology journals in 2006. Hepatology. 2009;49:2108-12.

  17. Castaño García A. Evolución de la calidad de los ensayos clínicos publicados en 4 revistas generales de medicina (1993-5 y 2004). Un estudio preliminar. [Diploma de Estudios Avanzados]. Pamplona: Universidad de Navarra; 2005.

  18. Moher D, Schulz KF, Altman D; CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA. 2001;285:1987-91.

  19. WMA.net. Declaración de Helsinki de la AMM. Principios éticos para las investigaciones médicas en seres humanos. Asociación Médica Mundial; 2014. (Consultado el 3 de abril de 2014.) Disponible en: http://www.wma. net/es/30publications/10policies/b3

  20. Thorpe KE, Zwarenstein M, Oxman AD, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ. 2009;180 E47-57.

  21. Gartlehner G, Hansen RA, Nissman D, et al. Criteria for distinguishing effectiveness from efficacy trials in systematic reviews. AHRQ Publication No. 06-0046; april 2006. (Consultado el 12 de enero de 2014.) Disponible en: http://archive.ahrq.gov/downloads/pub/evidence/pdf/efftrials/ efftrials pdf

  22. Grant AM, Altman DG, Babiker AB, et al. Issues in data monitoring and interim analysis of trials. Health Technol Assess. 2005;9 (7).

  23. Goldman B, LeBlanc M, Crowley J. Interim futility analysis with intermediate endpoints. J Clinical Trials. 2008;5:14-22.

  24. AusVet Animal Health Services. Calculate confidence limits for a sample proportion. (Consultado el 16 de septiembre de 2014.) Disponible en: http //epitools ausvet.com.au/content php?page=CIProportion&Sample- Size=141&Positive=1& Conf=0.95&Digits=1

  25. Stats Calculator. Confidence interval calculator for means. McCallum Layton; 2014. (Consultado el 16 de septiembre de 2014.) Disponible en: https://www.allto.co.uk/tools/statistic-calculators/confidence-interval- for-mean-calculator/

  26. Licciardone JC, Minotti DE, Gatchel RJ, et al. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial. Ann Fam Med. 2013;11:122-129.

  27. Yank V, Rennie D. Reporting of informed consent and ethics committee approval in clinical trials. JAMA. 2002;287: 2835-8.

  28. GraphPad Software. QuickCalcs. Confidence interval of a SD. (Consultado el 6 de diciembre de 2015.) Disponible en: http://graphpad.com/ quickcalcs/CISD1

  29. Sinha S, Sinha S, Ashby E, et al. Quality of reporting in randomised trials published in high-quality surgical journals. J Am Coll Surg. 2009;209:565- 71.e1.

  30. Agha RA, Camm CF, Doganay E, et al. Randomised controlled trials in plastic surgery: a systematic review of reporting quality. Eur J Plast Surg. 2014;37:55-62.

  31. Lai R, Chu R, Fraumeni M, et al. Quality of randomized controlled trials reporting in the primary treatment of brain tumors. J Clin Oncol. 2006;24:1136-44.

  32. Rutterford C, Taljaard M, Dixon S, et al. Reporting and methodological quality of simple size calculations in cluster randomized trials could be improved: a review. J Clin Epidemiol. 2015;68:716-23.

  33. Lucena C, Souza EM, Voinea GC, et al. A quality assessment of randomized controlled trials reports in endodontics. Int Endod J. 2017;50: 237-50.

  34. Zhang J, Chen X, Zhu Q, et al. Methodological reporting quality of randomized controlled trials: a survey of seven core journals of orthopaedics from Mainland China over 5 years following the CONSORT statement. Orthop Traumatol Surg Res. 2016;102:933-8.

  35. Lu Y, Yao Q, Gu J, et al. Methodological reporting of randomized clinical trials in respiratory research in 2010. Respir Care. 2013;58:1546-51.

  36. Zhai X, Wang Y, Mu Q, et al. Methodological reporting quality of randomized controlled trials in 3 leading diabetes journals from 2011 to 2013 following CONSORT statement: a system review. Medicine (Balt). 2015;94:e1083.

  37. Liu SS, Togioka BM, Hurley RW, et al. Methodological quality of randomized controlled trials of postoperative epidural analgesia: validation of the Epidural Analgesia Trial Checklist as a specific instrument to evaluate methodology. Reg Anesth Pain Med. 2010;35:549-55.

  38. Liu LQ, Morris PJ, Pengel LH. Compliance to the CONSORT statement of randomized controlled trials in solid organ transplantation: a 3-year overview. Transpl Int. 2013;26:300-6.

  39. Huang D, Jin X, Gao J, et al. Quality evaluation of randomized controlled trials reports of laparoscopy compared with open colorectal resection for colorectal cancer. Expert Rev Anticancer Ther. 2015;15:727-32.

  40. Signori A, Baccino A, Sormani MP. The quality of reports of randomized trials in multiple sclerosis: a review. Mult Scler. 2012;18:776-81.

  41. Diaz-Ordaz K, Froud R, Sheehan B, et al. A systematic review of cluster randomised trials in residential facilities for older people suggests how to improve quality. BMC Med Res Methodol. 2013;13:127.

  42. Masson P, Duthie FA, Ruster LP, et al. Consistency and completeness of reported outcomes in randomized trials of primary immunosuppression in kidney transplantation. Am J Transplant. 2013;13:2892-901.




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