Differences in quality between spanish clinical trials published in international journals and foreign trials published in worldwide read medical journals;Diferencias en la calidad de los ensayos clínicos españoles publicados en revistas internacionales y los aparecidos en revistas generales de medicina de gran difusión

Revista Clinica Espanola

Volumn 201, Issue 8, 2001, Pages 436-443

  Delgado Rodríguez, M Delgado ^b   Ruiz Canela, M ^b   De Irala Estevez J ^b   Llorca Diaz J ^c   Martinez Gonzalez M A ^b  

^a UNIVERSITY OF JAÉN   (Spain)

^b UNIVERSITY OF NAVARRA   (Spain)

^c UNIVERSITY OF CANTABRIA   (Spain)

Author keywords

Clinical trial; Epidemiological methods; Quality

Indexed keywords

EID: 0001206081     PISSN: 00142565     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0014-2565(01)70875-2     Document Type: Article

References (29)

1. Chalmers TC, Smith H Jr. Blackburn B, Silverman B, Schroeder B, Reitman D, Ambroz A. A method for assessing the quality of a randomized control trial. Control Clin Trials 1981; 2:31-49.
2. Moher D, Jabad A, Nichol G, Penman M, Tugwell P, Walsh S. Assessing the quality of reports of randomized clinical trials: an annotated bibliography of scales and checklists. Controlled Clin Trial 1995; 16:62-73.
3. Pettiti DB. Meta-analysis, decision analysis and cost-effectiveness analysis. Nueva York: Oxford University, 1994.
4. Lau J, Schmid CH, Chalmers TC. Cumulative meta-analysis of clinical trials builds evidence for exemplary medical care. J Clin Epidemiol 1995; 48:45-57.
5. Greenland S. Invited commentary: a critical look at some popular meta-analytical methods. Am J Epidemiol 1994; 140:290-296.
6. Olkin I. Invited commentary: «re: a critical look at some popular meta-analytical methods». Am J Epidemiol 1994; 140:297-300.
7. Greenland S. Quality scores are useless and potentially misleading. Reply to «re: a critical look at some popular meta-analytical methods». Am J Epidemiol 1994; 140:300-301.
8. Delgado-Rodríguez M, Sillero Arenas M. Inclusión de la calidad de una investigación en el metaanálisis. Gac Sanit 1995; 9:265-272.
9. Soto J, Galende I, Sacristán JA. Calidad de los ensayos clínicos publicados en España: valoración a través del análisis de 3 revistas durante el período 1985-1991. Med Clín (Barc) 1994; 102:241-245.
10. García López FJ. Impacto de la normativa legal en la calidad de los ensayos clinicos realizados en España. Med Clín (Barc) 1993; 100:770-777.
11. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996; 276:637-639.
12. Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. Incorporating variations in the quality of individual randomized trials into meta-analysis. J Clin Epidemiol 1992; 45:255-265.
13. Cuzick J. A Wilcoxon-type test for trend. Stat Med 1985; 4:87-90.
14. Moher D, Fortin P, Jabad RA, et al. Completeness of reporting of trials published in languages other than English: implications for conduct and reporting of systematic reviews. Lancet 1996; 347:363-366.
15. Ruiz-Canela M, Martínez-González MA, Gómez-Gracia E, Fernández-Crehuet J. Informed consent and approval by Institutional Review Boards in published reports on clinical trials. N Engl J Med 1999; 340:1114-1115.
16. Schulz KF, Grimes DA, Altman DG, Hayes RJ. Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology. BMJ 1996; 312: 742-744.
17. Oxman AD, Guyatt GH, Singer J, et al. Agreement among reviewers of review articles. J Clin Epidemiol 1991; 44:91-98.
18. Dickersin K. The existence of publication bias and risk factors for its ocurrence. JAMA 1990; 263:1.385-1.389.
19. Dickersin K, Min Y-I, Meinert CL. Factors influencing publication of research results follow-up of applications submitted to two institutional review boards. JAMA 1992; 267:374-378.
20. Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR. Publication bias in clinical research. Lancet 1991; 337:867-872.
21. Schulz KF, Chalmers I, Hayes RJ. Altman DG. Empirical evidence of bias. JAMA 1995; 273:408-412.
22. álvarez Solar M, López González ML, Cueto Espinar A. Indicadores bibliométricos, análisis temático y metodológico de la investigatión publicada en España sobre epidemiología y salud pública. Med Clín (Barc) 1998; 111:529-535.
23. Baños JE, Bosch F, Bigorra J, Guardiola E. Difusión internacional de los ensayos clínicos realizados en Espanã. Un análisis a través de su publicación en revistas científicas. Med Clín (Barc) 1994; 102:441-445.
24. Galende I, Sacristán JA, Soto J. Cómo mejorar la calidad de los ensayos clínicos. Med Clín (Barc) 1994; 102: 465-470.
25. Sacristán JA, Soto J, Galende I. Evaluación crítica de ensayos clínicos. Utilización de un check-lists. Med Clín (Barc) 1993; 100:780-787.
26. Freiman JA, Chalmers TC, Smith H Jr, Kuebler RR. The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. N Engl J Med 1978; 299:690-694.
27. Pocock SJ, Hughes MD, Lee RJ. Statistical problems in the reporting of clinical trials. N Engl J Med 1.987; 317:426-432.
28. Newell DJ. Intention-to-treat analysis: implications for quantitative and qualitative research. Int J Epidemiol 1992; 21:837-841.
29. Lewis JA, Machin D. Intnntion to treat - who should use ITT? Br J Cancer 1993; 68:647-650.