Guías para la escritura y publicación de trabajos de estudios experimentales

Enlaces a los títulos:

Directriz de presentación de informes para: Nombre del sitio web de la directriz (si está disponible) Referencias y número de PMID
Ensayos controlados aleatorizados

Declaración CONSORT

Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials.
Ann Int Med 2010;152 (11):726-32. PMID: 20335313
BMC Medicine 2010, 8:18. PMID: 20334633
BMJ 2010;340:c332. PMID: 20332509
J Clin Epi 2010; 63(8): 834-40 PMID: 20346629
Lancet 2010; 375(9721):1136 supplementary webappendix
Obstet Gynecol 2010;115(5):1063-70. PMID: 20410783
Open Med 2010;4(1):60-68.
PLoS Med 2010;7(3): e1000251. PMID: 20352064
Trials 2010, 11:32. PMID: 20334632

Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG, for the CONSORT Group. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trial.
BMJ 2010;340:c869. PMID: 20332511
J Clin Epi 2010; 63(8): e1-e37  PMID: 20346624

Traducción al español (Med Clin (Barc). 2011; 137 :213-5)

La Declaración CONSORT 2010 reemplaza a la directriz CONSORT 2001 (PMID: 11323066; PMID: 11304107)


El grupo CONSORT ha extendido la Declaración para que incluya algunos temas específicos:

CONSORT Efectos adversos:
Presentar informes de los efectos adversos en ensayos controlados aleatorizados (ECA)		 Ioannidis JPA, Evans SJW, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D, for the CONSORT Group*. Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement. Ann Intern Med 2004; 141(10):781-788.
PMID: 15545678

CONSORT No inferioridad:
Presentar informes de ECAs de no inferioridad y equivalencia		 Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJW, for the CONSORT Group. Reporting of Noninferiority and Equivalence Randomized Trials: An Extension of the CONSORT Statement. JAMA: The Journal of the American Medical Association 2006; 295(10):1152-1160.
PMID: 16522836

CONSORT Grupos:
Presentar informes de ECAs de grupos		 Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ 2004; 328(7441):702-708.
PMID: 15031246

CONSORT Herbario:
Presentar informes de ECAs con intervenciones herbarias		 Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C, for the CONSORT Group*. Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement. Ann Intern Med 2006; 144(5):364-367.
PMID: 16520478

CONSORT Intervenciones en tratamientos no farmacológicos

Boutron I, Moher D, Altman DG, Schulz K, Ravaud P, for the CONSORT group. Methods and Processes of the CONSORT Group: Example of an Extension for Trials Assessing Nonpharmacologic Treatments. Ann Intern Med. 2008:W60-W67.
PMID: 18283201

Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008 Feb 19;148(4):295-309.
PMID: 18283207

Resúmenes de CONSORT

Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF and the CONSORT Group (2008) CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med 5(1): e20. doi:10.1371/journal. pmed.0050020.
PMID: 18215107

Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, et al. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet, 26 de enero de 2008;371(9609):281-3.
PMID: 18221781


CONSORT Ensayos pragmáticos

Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008;337:a2390.
PMID: 19001484


STRICTA

Ensayos controlados de acupuntura

MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D; STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement.
PLoS Med. 2010; 7(6):e1000261. PMID: 20543992

La Declaración STRICTA, 2010 reemplaza a la directriz STRICTA, 2001 (PMID: 12184354 , PMID: 11926601 PMID: 11890439)

Otros grupos ajenos al grupo CONSORT también han intentado expandir los criterios de CONSORT a otras áreas de la investigación clínica:

Inmunoterapia alérgeno-específica
 Bousquet PJ, Brozek J, Bachert C, Bieber T, Bonini S, Burney P, et al. The CONSORT statement checklist in allergen-specific immunotherapy: a GA2LEN paper. Allergy 2009; 64(12):1737-45. PMID: 19860788

CONSORT-C (con la participación de niños): ensayos controlados aleatorizados (ECA) pediátricos
 Saint-Raymond A, Hill S, Martines J, Bahl R, Fontaine O, Bero L. CONSORT 2010. Lancet. 2010; 376(9737):229-30. PMID: 20656114

ECAs de medicina conductual Davidson KW, Goldstein M, Kaplan RM, Kaufmann PG, Knatterud GL, Orleans CT, Spring B, Trudeau KJ, Whitlock EP. Evidence-based behavioral medicine: what is it and how do we achieve it? Ann Behav Med 2003; 26(3):161-171.
PMID: 14644692

ECAs de terapia ocupacional Moberg-Mogren E, Nelson D. Evaluating the quality of reporting occupational therapy randomized controlled trials by expanding the CONSORT criteria. The American journal of occupational therapy : official publicationof the American Occupational Therapy Association 2006; 60(2):226-235.
PMID: 16596926

RedHot

Tratamientos homeopáticos

Dean ME, Coulter MK, Fisher P, Jobst K, Walach H. Reporting data on homeopathic treatments (RedHot): A supplement to CONSORT. Forschende Komplementarmedizin und Klassische Naturheilkunde 2006; 13(6):368-371.
PMID: 17200612

Estudios con intervención vibratoria
 Rauch F, Sievanen H, Boonen S, Cardinale M, Degens H, Felsenberg D, Roth J, Schoenau E, Verschueren S, Rittweger J. Reporting whole-body vibration intervention studies: recommendations of the International Society of Musculoskeletal and Neuronal Interactions. J Musculoskelet Neuronal Interact. 2010;10(3):193-8. PMID: 20811143

Intervenciones basadas en la música (ampliación de CONSORT y TREND)
 Robb SL, Carpenter JS, Burns DS. Reporting guidelines for music-based interventions. J Health Psychol. 2010 Aug 13. [Epub ahead of print]  PMID: 20709884

Intervenciones en eSalud
 Baker TB, Gustafson DH, Shaw B, Hawkins R, Pingree S, Roberts L, Strecher V. Relevance of CONSORT reporting criteria for research on eHealth interventions. Patient Educ Couns. 2010;81 Suppl:S77-86. PMID: 20843621

Ensayos de neuroncología, fase I y II


 GNOSIS Chang SM, Reynolds SL, Butowski N, Lamborn KR, Buckner JC, Kaplan RS, Bigner DD. GNOSIS: guidelines for neuro-oncology: standards for investigational studies-reporting of phase 1 and phase 2 clinical trials. Neuro oncol 2005; 7(4):425-434.
PMID: 16212807

Ensayos de neuroncología, cirugía


 GNOSIS

Chang S, Vogelbaum M, Lang FF, Haines S, Kunwar S, Chiocca EA, et al. GNOSIS: Guidelines for Neuro-Oncology: Standards for Investigational Studies - reporting of surgically based therapeutic clinical trials. Journal of Neuro-Oncology 2007;82(2):211-20.
PMID: 17146595
Comités de adjudicación en ensayos clínicos
Dechartres A, Boutron I, Roy C, Ravaud P. Inadequate planning and reporting of adjudication committees in clinical trials: recommendation proposal. J Clin Epidemiol 2009 Jul;62(7):695-702.
PMID: 19135860
Comités de vigilancia de datos, análisis interino e interrupción temprana en ensayos clínicos

Fernandes RM, van der Lee JH, Offringa M. A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials. BMC Pediatr 2009;9:77.
PMID: 20003383
Ensayos de fase II con datos históricos
Vickers AJ, Ballen V, Scher HI. Setting the bar in phase II trials: the use of historical data for determining “go/no go” decision for definitive phase III testing. Clin Cancer Res 2007; 13(3):972-976.
PMID: 17277252
Evaluaciones no aleatorizadas de intervenciones de salud pública y conductuales TREND

Des Jarlais DC, Lyles C, Crepaz N, Trend Group. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. American Journal of Public Health 2004; 94(3):361-366.
PMID: 14998794

Traducción al español (Med Clin (Barc). 2005;125(Supl 1):38-42)

Intervenciones basadas en la música (ampliación de CONSORT y TREND)
 Robb SL, Carpenter JS, Burns DS. Reporting guidelines for music-based interventions. J Health Psychol. 2010 Aug 13. [Epub ahead of print]  PMID: 20709884
Estudios no aleatorizados
Reeves BC, Gaus W. Guidelines for reporting non-randomised studies. Forsch Komplementarmed Klass Naturheilkd 2004; 11 Suppl 1:46-52.
PMID: 15353903
Investigación comparativa de la eficacia
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 in Health 2009; 12(8):1044-52. PMID: 19793072
Estudios de intervención para el control de infecciones ORION Stone SP, Cooper BS, Kibbler CC, Cookson BD, Roberts JA, Medley GF, Duckworth G, Lai R, Ebrahim S, Brown EM, Wiffen PJ, Davey PG. The ORION statement: guidelines for transparent reporting of Outbreak Reports and Intervention studies Of Nosocomial infection.
J Antimicrob Chemother 2007; 59(5):833-840. PMID: 17387116
Lancet Infect Dis 2007; 7: 282–288.
PMID: 17376385
Investigación básica en homeopatía REHBaR Stock-Schroer B, Albrecht H, Betti L, Endler PC, Linde K, Ludtke R, et al. Reporting experiments in homeopathic basic research (REHBaR) - a detailed guideline for authors. Homeopathy 2009;98(4):287-98. PMID: 19945681



Leech NL, Onwuegbuzie AJ. Guidelines for conducting and reporting mixed research in the field of counseling and beyond. Journal of Counseling and Development 2010; 88(1):61-9.

Última revisión: 07 de Diciembre de 2011