Methodological aspects of Guidelines of Clinical Practice conducted at the University of Antioquia based on the methodological guide of the Ministry of Health and Protection of Colombia
DOI:
https://doi.org/10.17533/udea.iatreia.323691Keywords:
body of evidence, guidelines development, GRANDE, quality assessment, recommendationsAbstract
In 2010 The Colombian Ministry of Health and Social Protection (MOH) started a process to develop several evidence-based clinical practice guidelines (CPG) according to the main health priorities of the country. The National Center for Research in Evidence and Technologies in Health (an Alliance between the University of Antioquia, University Javeriana and National University of Colombia) conducted 90% of the 55 GPCs funded by the MOH; of these, the University of Antioquia leaded the development of eight. This article describes the methodological steps that were followed for the preparation of these GPC, including: creating the guideline development group, defining the focus, scope and objectives, defining the clinical question, rating the quality of primary studies, and synthesis of evidence. Subsequently, we describe the process to assess the quality of the evidence with “The Grading of Recommendations Assessment, Development and Evaluation (GRADE)” system and to formulate the recommendations. We also explain the economic assessments as well as the proposal for the implementation of the GPC. We presented a synthesis of the experience of this project at the University of Antioquia presented.
Downloads
References
(1.) Colombia. Ministerio de Salud y Protección Social, Fundación Santafé de Bogotá, Centro de Estudios e Investigación en Salud. Guía Metodológica para la elaboración de Guías de Atención Integral en el Sistema General de Seguridad Social en Salud colombiano [Internet]. Bogotá: Ministerio de Salud y Protección Social; 2010 [consultado 2016 Abr 17]. Disponible en: https://www.minsalud.gov.co/salud/Documents/Gu%C3%ADa%20Metodol%C3%B3gica%20para%20la%20elaboraci%C3%B3n%20de%20gu%C3%ADas.pdf
(2.) Instituto de Evaluación Tecnológica en Salud. Manual para la elaboración de evaluaciones económicas en salud. Bogotá: IETS; 2014 [consultado 2016 Abr 17]. Disponible en: http://www.iets.org.co/Manuales/Manuales/Manual%20evaluacio%CC%81n%20econo%CC%81mica%20web%2030%20sep.pdf
(3.) Colombia Ministerio de Salud y Protección Social, Colciencias, Universidad de Antioquia. Guía de práctica clínica para prevención, diagnóstico y tratamiento de la enfermedad diarreica aguda en niños menores de 5 años SGSS – 2013 Guías No. 8 GPC-EDA [Internet]. Bogotá: SGSS; 2013 [consultado 2016 Feb]. Disponible en: http://gpc.minsalud.gov.co/gpc_sites/Repositorio/Conv_500/GPC_diarrea/gpc_diarrea_completa.aspx
(4.) Colombia. Ministerio de Salud y Protección Social, Colciencias, Universidad de Antioquia. Guía de práctica clínica para el Síndrome Coronario Agudo. Guía No 17. GPC-SCA [Internet]. Bogotá: GPC-SCA; 2013 [consultado 2016 Feb]. Disponible en: http://gpc.minsalud.gov.co/gpc_sites/Repositorio/Conv_500/GPC_s_coronario/gpc_s_coronario_completa.aspx
(5.) Colombia. Ministerio de Salud y Protección Social. Guía de práctica clínica para la detección temprana, atención integral, seguimiento y rehabilitación de pacientes con diagnóstico de distrofia muscular. Guía No. 37 [Internet]. Bogotá: El Ministerio; 2013 [consultado 2015 Mar 25]. Disponible en: http://gpc.minsalud.gov.co/gpc_sites/Repositorio/Conv_563/GPC_distrofia/GPC_distrofia_muscular_completa.aspx
(6.) Colombia. Ministerio de Salud y Protección Social. Guía de práctica clínica para el diagnóstico y tratamiento preoperatorio, intraoperatorio y postoperatorio de la persona amputada, la prescripción de la prótesis y la rehabilitación integral. Guía No. 55 [Internet]. Bogotá: El Ministerio; 2016 [consultado 2016 Feb]. Disponible en: http://gpc.minsalud.gov.co/gpc_sites/Repositorio/Conv_637/GPC_amputacion/gpc_amputacion_completa.aspx
(7.) Colombia. Ministerio de Salud y Protección Social. Guía de Práctica Clínica para la prevención, diagnóstico, tratamiento y rehabilitación de la falla cardíaca en población mayor de 18 años clasificación B, C y D. Guía No. 53 [Internet]. Bogotá: El Ministerio; 2016 [consultado 2016 Feb]. Disponible en: http://gpc.minsalud.gov.co/gpc_sites/Repositorio/Conv_637/GPC_falla_ccardiaca/gpc_falla_cardiaca_completa.aspx
(8.) Ministerio de Salud y Protección Social, Colciencias. Guía de práctica clínica del recién nacido con trastorno respiratorio. Guía No. 05 [Internet]. Bogotá: El Ministerio; 2013 [consultado 2016 Feb] Disponible en: http://gpc.minsalud.gov.co/gpc_sites/Repositorio/Conv_500/GPC_rntr/gpc_rntr_completa.aspx
(9.) Colombia. Ministerio de Salud y Protección Social, Universidad de Antioquia. Guía de padres y cuidadores para la evaluación del riesgo y manejo inicial de la neumonía en niños y niñas menores de 5 años y bronquiolitis en niños y niñas menores de 2 años. Guía No. 42 [Internet]. Bogotá: El Ministerio; 2014 [consultado 2016 Feb] Disponible en: http://gpc.minsalud.gov.co/gpc_sites/Repositorio/Otros_conv/GPC_neumonia/GPC_neumonia_completa.aspx
(10.) Colombia. Ministerio de Salud y Protección Social, Colciencias. Guía de Práctica Clínica para la prevención, detección temprana y tratamiento de las complicaciones del embarazo, parto o puerperio. Guías No. 11-15 [Internet]. Bogotá: El Ministerio; 2013 [consultado 2016 Feb]. Disponible en: http://gpc.minsalud.gov.co/gpc_sites/Repositorio/Conv_500/GPC_embarazo/GPC_embarazo_completa.aspx
(11.) Qaseem A, Forland F, Macbeth F, Ollenschläger G, Phillips S, van der Wees P, et al. Guidelines International Network: toward international standards for clinical practice guidelines. Ann Intern Med. 2012 Apr;156(7):525-31. DOI 10.7326/0003-4819-156-7-201204030-00009.
(12.) Schwartz PJ, Breithardt G, Howard AJ, Julian DG, Rehnqvist Ahlberg N. Task Force Report: The legal implications of medical guidelines--a Task Force of the European Society of Cardiology. Eur Heart J. 1999 Aug;20(16):1152-7. DOI 10.1053/euhj.1999.1677.
(13.) Reveiz L, Tellez DR, Castillo JS, Mosquera PA, Torres M, Cuervo LG, et al. Prioritization strategies in clinical practice guidelines development: a pilot study. Health Res Policy Syst. 2010 Mar;8:7. DOI 10.1186/1478-4505-8-7.
(14.) Pardo Turriago R, Molano Soto Vivian.Las guías de práctica clínica: una herramienta de participación en la construcción de una política pública. Acta Neurol Colomb. 2014; 30(4):307-313.
(15.) SIGN. Sign 50 A guideline developer’s handbook [Internet]. Edinburgh: Scottish Intercollegiate Guidelines Network; 2014 [consultado 2016 Abr 17]. Disponible en: http://www.sign.ac.uk/pdf/SIGN50_2014.pdf
(16.) NICE. Topic Selection Programme Process Manual [Internet]. Manchester: NICE; October 2014 [consultado 2016 Ene]. Disponible en: https://www.nice.org.uk/process/pmg20/chapter/introduction-andoverview#choice-of-guideline-topics
(17.) Chile. Ministerio de Salud. Pauta para la Elaboración, Aplicación y Evaluación de Guías de Práctica Clínica [Internet]. Santiago: Ministerio de Salud. Chile; 2002. p. 0-80. [consultado 2016 Abr 17]. Disponible en: http://www.minsal.gob.cl/portal/url/item/6d054172ffd27defe04001011f010ee8.pdf
(18.) Metodología para el desarrollo y la actualización de guías de práctica clínica: estado actual [Internet]. Rev Med Inst Mex Seguro Soc 2016 [consultado 2016 Ene]; 54 (1). Disponible en: http://new.medigraphic.com/cgi-bin/resumen.cgi?IDARTICULO=63580
(19.) Guyatt G, Oxman AD, Akl EA, Kunz R, Vist G, Brozek J, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. 2011 Apr;64(4):383-94. DOI 10.1016/j.jclinepi.2010.04.026.
(20.) Guyatt GH, Oxman AD, Kunz R, Atkins D, Brozek J, Vist G, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol. 2011 Apr;64(4):395-400. DOI 10.1016/j.jclinepi.2010.09.012.
(21.) The ADAPTA collaboration 2009. THE ADAPTE Process: resource toolkit for Guideline Adaptation. Version 2.0. [consultado 2016 Ene]. Disponible en: http://www.g-i-n.net/document-store/workinggroups-documents/adaptation/adapte-resource-toolkit-guideline-adaptation-2-0.pdf
(22.) Higgins JPT, Green S, editors. The Cochrane Collaboration. In: Cochrane Handbook for Systematic Reviews of Interventions [Internet]. Version 5.1.0. London: Cochrane; 2011 [cited 2016 Feb]. Available from: http://handbook.cochrane.org/
(23.) Halladay CW, Trikalinos TA, Schmid IT, Schmid CH, Dahabreh IJ. Using data sources beyond PubMed has a modest impact on the results of systematic reviews of therapeutic interventions. J Clin Epidemiol. 2015 Sep;68(9):1076-84. DOI 10.1016/j.jclinepi.2014.12.017.
(24.) Gerdesmeyer L, Gollwitzer H, Diehl P, Wagner K. Evidence-based medicine and clinical trials in pain practice and orthopedics. Pain Pract. 2005 Dec;5(4):289-97.
(25.) Tennent DJ, Bailey JR, Ficke JR, Stinner DJ. Evidence-based medicine in military orthopaedics: are we doing our part? J Surg Orthop Adv. 2014 Summer; 23(2):64-7.
(26.) Cohn JN. Heart failure in 2013: Continue what we are doing to treat HF, but do it better. Nat Rev Cardiol. 2014 Feb;11(2):69-70. DOI 10.1038/nrcardio.2013.212.
(27.) Song F, Parekh S, Hooper L, Loke YK, Ryder J, Sutton AJ, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess. 2010 Feb;14(8):iii, ix-xi, 1-193. DOI 10.3310/hta14080.
(28.) AGREE Collaboration. Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project. Qual Saf Health Care. 2003 Feb;12(1):18-23.
(29.) Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, et al. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010 Dec;182(18):E839-42. DOI 10.1503/cmaj.090449.
(30.) AGREE Advancing the science of practice guidelines [Internet]. Canadá: AGREE. [cited 2016 Mar 7]. AGREE History: 10 Years of AGREE (2003-2013). Available from: http://www.agreetrust.org/about-the-agree-enterprise/agree-history/
(31.) Higgins JP, Altman D. Assessing the risk of bias in included studies. In: Higgins J, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions. Version 5.0.1. Chichester, UK: John Wiley & Sons; 2008. p 191-254.
(32.) Shea BJ, Grimshaw JM, Wells GA, Boers M, Andersson N, Hamel C, et al. Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews. BMC Med Res Methodol. 2007 Feb;7:10. DOI 10.1186/1471-2288-7-10.
(33.) Whiting PF, Rutjes AW, Westwood ME, Mallett S, Deeks JJ, Reitsma JB, et al. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med. 2011 Oct;155(8):529-36. DOI 10.7326/0003-4819-155-8-201110180-00009.
(34.) Balshem H, Helfand M, Schünemann HJ, Oxman AD, Kunz R, Brozek J, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011 Apr;64(4):401-6. DOI 10.1016/j.jclinepi.2010.07.015.
(35.) Guyatt GH, Oxman AD, Vist G, Kunz R, Brozek J, Alonso-Coello P, et al. GRADE guidelines: 4. Rating the quality of evidence—study limitations (risk of bias). J Clin Epidemiol. 2011 Apr;64(4):407-15. DOI 10.1016/j.jclinepi.2010.07.017.
(36.) Guyatt GH, Oxman AD, Kunz R, Woodcock J, Brozek J, Helfand M, et al. GRADE guidelines: 7. Rating the quality of evidence--inconsistency. J Clin Epidemiol.2011 Dec;64(12):1294-302. DOI 10.1016/j.jclinepi.2011.03.017.
(37.) Guyatt GH, Oxman AD, Kunz R, Woodcock J, Brozek J, Helfand M, et al. GRADE guidelines: 8. Rating the quality of evidence--indirectness. J Clin Epidemiol. 2011 Dec;64(12):1303-10. DOI 10.1016/j.jclinepi.2011.04.014.
(38.) Guyatt GH, Oxman AD, Kunz R, Brozek J, Alonso-Coello P, Rind D, et al. GRADE guidelines 6. Rating the quality of evidence--imprecision. J Clin Epidemiol. 2011 Dec;64(12):1283-93. DOI 10.1016/j.jclinepi.2011.01.012.
(39.) Guyatt GH, Oxman AD, Montori V, Vist G, Kunz R, Brozek J, et al. GRADE guidelines: 5. Rating the quality of evidence--publication bias. J Clin Epidemiol. 2011 Dec;64(12):1277-82. DOI 10.1016/j.jclinepi.2011.01.011.
(40.) Guyatt GH, Oxman AD, Sultan S, Glasziou P, Akl EA, Alonso-Coello P, et al. GRADE guidelines: 9. Rating up the quality of evidence. J Clin Epidemiol. 2011 Dec;64(12):1311-6. DOI 10.1016/j.jclinepi.2011.06.004.
(41.) Schünemann HJ, Mustafa R, Brozek J, Santesso N, Alonso-Coello P, Guyatt G, et al. GRADE Guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health. J Clin Epidemiol. 2016 Aug;76:89-98. DOI 10.1016/j.jclinepi.2016.01.032.
(42.) Balion C, Don-Wauchope A, Hill S, Santaguida PL, Booth R, Brown JA, et al. Use of Natriuretic Peptide Measurement in the Management of Heart Failure [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Nov. [cited 2016 Mar 7]. Available from: http://www.ncbi.nlm.nih.gov/books/NBK179184/
(43.) Salanti G, Del Giovane C, Chaimani A, Caldwell DM, Higgins JP. Evaluating the quality of evidence from a network meta-analysis. PLoS One. 2014 Jul;9(7):e99682. DOI 10.1371/journal.pone.0099682.
(44.) Chatterjee S, Biondi-Zoccai G, Abbate A, D’Ascenzo F, Castagno D, Van Tassell B, et al. Benefits of β blockers in patients with heart failure and reduced ejection fraction: network meta-analysis. BMJ. 2013 Jan;346:f55. DOI 10.1136/bmj.f55. Erratum in: BMJ. 2013;346:f596. DOI 10.1136/bmj.f55.
(45.) Andrews JC, Schünemann HJ, Oxman AD, Pottie K, Meerpohl JJ, Coello PA, et al. GRADE guidelines: 15. Going from evidence to recommendation-determinants of a recommendation’s direction and strength. J Clin Epidemiol. 2013 Jul;66(7):726-35. DOI 10.1016/j.jclinepi.2013.02.003.
(46.) Guyatt GH, Oxman AD, Kunz R, Falck-Ytter Y, Vist GE, Liberati A, et al. Going from evidence to recommendations. BMJ. 2008 May;336(7652):1049-51. DOI 10.1136/bmj.39493.646875.AE. Erratum in: BMJ. 2008 Jun;336(7658). DOI10.1136/bmj.a402.
(47.) Guyatt GH, Oxman AD, Kunz R, Jaeschke R, Helfand M, Liberati A, et al. Incorporating considerations of resources use into grading recommendations. BMJ. 2008 May;336(7654):1170-3. DOI 10.1136/bmj.39504.506319.80. Erratum in: BMJ.2008 Jun 21;336(7658): DOI:10.1136/bmj.a403.
(48.) Gómez-Doblas JJ. Implementación de guías clínicas. Rev Esp Cardiol. 2006 Nov;59(Supl 3):29-35. DOI 10.1157/13096255.
(49.) Colombia. Ministerio de Salud y Protección Social. Manual de implementación de guías de práctica clínica basadas en evidencia, en instituciones prestadoras de servicios de salud en Colombia. Bogotá: MinSalud; 2014. Disponible en: http://gpc.minsalud.gov.co/recursos/Documentos%20compartidos/Manual_de_implementacion.pdf
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2017 Iatreia
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.
Papers published in the journal are available for use under the Creative Commons license, specifically Attribution-NonCommercial-ShareAlike 4.0 International.
The papers must be unpublished and sent exclusively to the Journal Iatreia; the author uploading the contribution is required to submit two fully completed formats: article submission and authorship responsibility.
