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Extensiones de guías para reportar tipos de estudio en medicina / Extensions of guidelines for reporting types of studies in medicine
Resumen
Resumen
El uso de diferentes guías para reportar tipos de estudios en el campo médico ha sido ampliamente difundido desde hace décadas; sin embargo, su adherencia y utilización por una parte importante de investigadores aún es limitada. Esto ha impactado de manera negativa en la difusión de nuevos hallazgos, lo cual ha generado críticas en relación a cómo se diseñan, realizan y reportan investigaciones médicas. Paralelo a ello, existen extensiones a dichas guías, las cuales son poco conocidas y utilizadas por el personal involucrado en labores de investigación, estas se enfocan en aproximaciones más específicas para reportar diferentes tipos de estudios entre los que destacan: metaanálisis, revisiones sistemáticas, ensayos clínicos aleatorizados, estudios de precisión diagnóstica, estudios observacionales, entre otros. Por tal motivo, es de vital importancia su promoción, conocimiento y utilización. El objetivo de la presente revisión es sintetizar las principales extensiones de las guías utilizadas en investigación médica. Para tal efecto se revisaron sus principales características, así como escenarios de aplicación de acuerdo con el nivel de evidencia; su adecuada adhesión permitirá al personal de salud involucrado en labores de investigación incrementar la transparencia y calidad de sus hallazgos, contemplar fuentes potenciales de sesgos, así como el desarrollo de buenas prácticas para la presentación de sus resultados de acuerdo al tipo de estudio seleccionado.
Abstract
The use of different guides to report types of studies in the medical field has been widely disseminated for decades, however, their adherence and use by an important part of researchers is still limited, this has negatively impacted the dissemination of new findings, which has generated criticism regarding how medical research is designed, conducted and reported. Parallel to this, there are extensions to these guidelines which are little known and used by the personnel involved in research work, they focus on more specific approaches to report different types of studies, among which are: meta-analysis, systematic reviews, clinical trials randomized, diagnostic accuracy studies, observational studies, among others; for this reason, its promotion, knowledge, and use is of vital importance. The objective of this review is to synthesize the main extensions of the guidelines used in medical research; for this purpose, its main characteristics were reviewed, as well as application scenarios according to the level of evidence; Its adequate adherence will allow health personnel involved in research work to increase the transparency and quality of their findings, contemplate potential sources of bias, as well as the development of good practices for the presentation of their results according to the type of study selected.
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Page MJ, Shamseer L, Altman DG, Tetzlaff J, Sampson M, Tricco AC, et al. Epidemiology and reporting characteristics of systematic reviews of biomedical research: a cross-sectional study. Low N, ed. PLoS Med. 2016;13(5):e1002028. doi:10.1371/journal.pmed.1002028.
Morton SC, Costlow MR, Graff JS, Dubois RW. Standards and guidelines for observational studies: quality is in the eye of the beholder. J Clin Epidemiol. 2016;71:3-10. doi:10.1016/j. jclinepi.2015.10.014.
Simera I, Altman DG. Writing a research article that is “fit for purpose”: EQUATOR Network and reporting guidelines. Evid Based Med. 2009;14(5):132-134. doi:10.1136/ebm.14.5.132.
Simera I, Altman DG. Reporting medical research. Int J Clin Pract. 2013;67(8):710-716. doi:10.1111/ijcp.12168.
Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ. 2010; 340:c723. doi:10.1136/bmj.c723.
Mozetic V, Leonel L, Leite Pacheco R, de Oliveira Cruz Latorraca C, Guimarães T, Logullo P, et al. Reporting quality and adherence of randomized controlled trials about statins and/ or fibrates for diabetic retinopathy to the CONSORT check-list. Trials. 2019;20(1):729. doi:10.1186/s13063-019-3868-4.
Hendriksma M, Joosten MHMA, Peters JPM, Grolman W, Stegeman I. Evaluation of the Quality of Reporting of Observational Studies in Otorhinolaryngology - Based on the STROBE Statement. PLoS ONE. 2017;12(1):e0169316. doi:10.1371/journal.pone.0169316.
Khan MS, Shaikh A, Ochani RK, Akhtar T, Fatima K, Khan SU, et al. Assessing the quality of abstracts in randomized controlled trials published in high impact cardiovascular journals. Circ Cardiovasc Qual Outcomes. 2019;12(5):e005260. doi:10.1161/CIRCOUTCOMES.118.005260.
Ioannidis JPA. Why most clinical research is not useful. PLoS Med. 2016;13(6):e1002049. doi:10.1371/journal.pmed.1002049.
Moher D. Reporting guidelines: doing better for readers. BMC Med. 2018;16(1):233. doi:10.1186/s12916-018-1226-0.
Hernández-Vargas A, Pérez-Manjarrez FE, Mendiola-Pastrana IR, López-Ortiz E, López-Ortiz G. Most common mistakes when writing medical original articles. Gac Med Mex. 2020;155(6): 635-640. doi.org/10.24875/gmm.19005172.
Altman DG. The scandal of poor medical research. BMJ. 1994 Jan 29;308(6924):283–284. doi.org/10.1136/bmj.308. 6924.283.
Bohannon J. Who’s Afraid of Peer Review? Science. 2013; 342(6154):60–65.
Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009;374(9683):86- 89. doi.org/10.1016/S0140-6736(09)60329-9.
The EQUATOR Network | Enhancing the QUAlity and Transparency Of Health Research [Internet]. [Citado 2022 Mar 22]. Disponible en: https://www.equator-network.org/
Brooke BS, Schwartz TA, Pawlik TM. MOOSE Reporting Guidelines for Meta-analyses of Observational Studies. JAMA Surg. 2021;156(8):787. doi:10.1001/jamasurg.2021.0522.
Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Methodology Review Group, ed. Cochrane Database Syst Rev. 2012; 11(11):MR000030. doi:10.1002/14651858.MR000030.pub2.
PAHO. Guidelines for reporting health research [Internet]. [Citado 2022 Jun 07]. Disponible en: https://www.paho.org/ hq/dmdocuments/2014/Reporting-guidelines-in-journals.pdf.
Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015;4(1):1. doi:10.1186/2046-4053-4-1.
Pussegoda K, Turner L, Garritty C, Mayhew A, Skidmore B, Stevens A, et al. Systematic review adherence to methodological or reporting quality. Syst Rev. 2017;6(1):131. doi:10.1186/s13643-017-0527-2.
Page MJ, Moher D, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. PRISMA 2020 explanation and elaboration: updated guidance and exemplars for reporting systematic reviews. BMJ. 2021;372:n160. doi:10.1136/bmj.n160.
Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021; 372:n71. doi:10.1136/bmj.n71.
Welch V, Petticrew M, Petkovic J, Moher D, Waters E, White H, et al. Extending the PRISMA statement to equity-focused systematic reviews (PRISMA-E 2012): explanation and elaboration. J Clin Epidemiol. 2016;70:68-89. doi:10.1016/j. jclinepi.2015.09.001.
Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015;350:g7647-g7647. doi:10.1136/ bmj.g7647.
Hutton B, Salanti G, Caldwell DM, Chaimani A, Schmid CH, Cameron C, et al. The PRISMA Extension Statement for Reporting of Systematic Reviews Incorporating Network Meta-analyses of Health Care Interventions: Checklist and Explanations. Ann Intern Med. 2015;162(11):777-784. doi:10.7326/ M14-2385.
Zorzela L, Loke YK, Ioannidis JP, Golder S, Santaguida P, Altman DG, et al. PRISMA harms checklist: improving harms reporting in systematic reviews. BMJ. 2016;352:i157. doi:10.1136/bmj.i157.
Tricco AC, Lillie E, Zarin W, O’Brien KK, Colquhoun H, Levac D, et al. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation. Ann Intern Med. 2018;169 (7):467-473. doi:10.7326/M18-0850.
Rethlefsen ML, Kirtley S, Waffenschmidt S, Ayala AP, Moher D, Page MJ, et al. PRISMA-S: an extension to the PRISMA Statement for Reporting Literature Searches in Systematic Reviews. Syst Rev. 2021;10(1):39. doi:10.1186/ s13643-020-01542-z.
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi:10.1016/j. ijsu.2011.10.001.
Cuschieri S. The CONSORT statement. Saudi J Anaesth. 2019;13(5):27. doi:10.4103/sja.SJA_559_18.
Spieth PM, Kubasch AS, Penzlin AI, Illigens BMW, Barlinn K, Siepmann T. Randomized controlled trials - a matter of design. Neuropsychiatr Dis Treat. Published online 2016:1341- 1349. doi:10.2147/NDT.S101938.
Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. doi:10.1136/bmj.g1687.
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355:i5239. doi:10.1136/bmj.i5239.
Montgomery P, Grant S, Mayo-Wilson E, Macdonald G, Michie S, Hopewell S, et al. Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension. Trials. 2018;19(1):407. doi:10.1186/ s13063-018-2733-1.
Juszczak E, Altman DG, Hopewell S, Schulz K. Reporting of multi-arm parallel-group randomized trials: extension of the CONSORT 2010 statement. JAMA. 2019;321(16):1610-1620. doi:10.1001/jama.2019.3087.
Cheng A, Kessler D, Mackinnon R, Chang TP, Nadkarni VM, Hunt EA, et al. Reporting guidelines for health care simulation research: extensions to the CONSORT and STROBE statements. Simul Healthc. 2016;11(4):238-248. doi:10.1097/ SIH.0000000000000150.
Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P, CONSORT NPT Group. CONSORT statement for randomized trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann Intern Med. 2017;167(1):40-47. doi:10.7326/M17-0046
Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390. doi:10.1136/bmj.a2390.
Ioannidis JPA, Evans SJW, Gøtzsche PC, O’Neill RT, Altman DG, Schulz K, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141(10):781-788. doi:10.7326/ 0003-4819-141-10-200411160-00009.
Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, et al.. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. von Elm E, ed. PLoS Med. 2008;5(1):e20. doi:10.1371/journal.pmed.0050020.
Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD, et al. Reporting of Patient-Reported Outcomes in Randomized Trials: The CONSORT PRO Extension. JAMA. 2013;309(8):814-822. doi:10.1001/jama.2013.879.
Welch VA, Norheim OF, Jull J, Cookson R, Sommerfelt H, Tugwell P, et al. CONSORT-Equity 2017 extension and elaboration for better reporting of health equity in randomised trials. BMJ. 2017;359:j5085. doi:10.1136/bmj.j5085.
Grant S, Mayo-Wilson E, Montgomery P, Macdonald G, Michie S, Hopewell S, et al. CONSORT-SPI 2018 explanation and elaboration: guidance for reporting social and psychological intervention trials. Trials. 2018;19(1):406. doi:10.1186/ s13063-018-2735-z.
Liu X, Cruz Rivera S, Moher D, Calvert MJ, Denniston AK, The SPIRIT-AI, CONSORT-AI Working Group, et al. Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension. Nat Med. 2020;26(9):1364-1374. doi:10.1038/s41591-020-1034-x.
Chan A-W, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi:10.1136/bmj.e7586.
Calvert M, King M, Mercieca-Bebber R, Aiyegbusi O, Kyte D, Slade A, et al. SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials. BMJ Open. 2021;11(6):e045105. doi:10.1136/bmjopen-2020-045105.
Kyte D, Duffy H, Fletcher B, Gheorghe A, Mercieca-Bebber R, King M, et al. Systematic evaluation of the Patient-Reported Outcome (PRO) content of clinical trial protocols. Briel M, ed. PLoS ONE. 2014;9(10):e110229. doi:10.1371/journal. pone.0110229.
Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200- 207. doi:10.7326/0003-4819-158-3-201302050-00583.
Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan A-W, King MT, et al. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: The SPIRIT-PRO extension. JAMA. 2018;319(5):483-494. doi:10.1001/jama.2017.21903.
Rivera SC, Liu X, Chan AW, Denniston AK, Calvert MJ. Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension. BMJ. 2020;370:m3210. doi:10.1136/bmj.m3210.
Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, et al. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015; 351:h5527. doi:10.1136/bmj.h5527.
Cohen JF, Korevaar DA, Gatsonis CA, Glasziou PP, Hooft L, Moher D, et al. STARD for abstracts: essential items for reporting diagnostic accuracy studies in journal or conference abstracts. BMJ. 2017;358:j3751. doi:10.1136/bmj.j3751.
Noel-Storr AH, McCleery JM, Richard E, Ritchie CW, Flicker L, Cullum SJ, et al. Reporting standards for studies of diagnostic test accuracy in dementia: The STARD-dem Initiative. Neurology. 2014;83(4):364-373. doi:10.1212/ WNL.0000000000000621.
Vandenbroucke JP, von Elm E, Altman DG, Gøtzsche PC, Mulrow CD, Pocock SJ, et al. Strengthening the reporting of observational studies in epidemiology (STROBE): Explanation and elaboration. Int J Surg. 2014;12(12):1500-1524. doi:10.1016/j.ijsu.2014.07.014.
Hörnell A, Berg C, Forsum E, Larsson C, Sonestedt E, Åkesson A, et al. Perspective: An extension of the STROBE statement for observational studies in nutritional epidemiology (STROBE-nut): explanation and elaboration. Adv Nutr. 2017;8(5):652-678. doi:10.3945/an.117.015941.
Little J, Higgins JPT, Ioannidis JPA, Moher D, Gagnon F, von Elm E, et al. STrengthening the REporting of Genetic Association Studies (STREGA)— An extension of the STROBE statement. PLoS Med. 2009;6(2):e1000022. doi:10.1371/journal. pmed.1000022.
Benchimol EI, Smeeth L, Guttmann A, Harron K, Moher D, Petersen I, et al. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement. PLoS Med. 2015;12(10):e1001885. doi:10.1371/ journal.pmed.1001885.
Langan SM, Schmidt SA, Wing K, Ehrenstein V, Nicholls SG, Filion KB, et al. The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE). BMJ. 2018;363:k3532. doi:10.1136/bmj.k3532.
Riley DS, Barber MS, Kienle GS, Aronson JK, von Schoen-Angerer T, Tugwell P, et al. CARE guidelines for case reports: explanation and elaboration document. Journal of Clinical Epidemiology. 2017;89:218-235. doi:10.1016/j.jclinepi.2017.04.026.
O’Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for Reporting Qualitative Research: A Synthesis of Recommendations. Academic Medicine. 2014;89(9):1245- 1251. doi:10.1097/ACM.0000000000000388.
Agha RA, Franchi T, Sohrabi C, Mathew G, Kerwan A, Thoma A, et al. The SCARE 2020 Guideline: Updating Consensus Surgical CAse REport (SCARE) Guidelines. International Journal of Surgery. 2020;84:226-230. doi:10.1016/j. ijsu.2020.10.034.
Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. International Journal for Quality in Health Care. 2007;19(6):349-357. doi:10.1093/intqhc/mzm042.
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