Research design: Classification algorithm and essential features
DOI:
https://doi.org/10.52379/mcs.v7i3.349Keywords:
Medicine, research, research desing, research methodologyAbstract
While primary research involves the active participation of the researcher, secondary research consists of the synthesis and analysis of results organized and published by others as primary research. In medicine, primary research has sought to reach a valid conclusion to improve human health using scientific methods. Therefore, primary research requires well-designed research that is sustained on a sound basis of detailed methodology and governed by ethical clinical principles. This is important, since in the Medical Sciences, meaningful conclusions can only be drawn from the data collected and the results obtained through an appropriate scientific design. Therefore, the selection of a correct research design is important to answer the questions posed by the researcher in an unbiased and scientific manner. In this review article, an algorithm for classifying primary research designs is presented. It also discusses the different types of designs used in primary medical research based on the quantitative paradigm. The key features of the concept, methodological aspects, advantages, and limitations, as well as the possibilities of using different designs, are illustrated with examples. This knowledge is crucial since the quality, reliability, and publishability of research in medicine depend decisively on the selection of an appropriate research design.
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Kapoor MC. Types of studies and research design. Indian J Anaesth. 2016;60(9):626–30. https://doi.org/10.4103/0019-5049.190616
Röhrig B, du Prel J-B, Wachtlin D, Blettner M. Types of Study in Medical Research. Dtsch Arzteblatt Int. 2009;106(15):262–8. https://doi.org/10.3238/arztebl.2009.0262
Gratton C, Jones I. Research methods for sports studies. 2nd ed. London?; New York: Routledge; 2010. 304 p.
Lowe C, Zemliansky P, Driscoll D, Stewart M, Vetter M, editors. Writing spaces: readings on writing. West Lafayette, Indiana?; Anderson, South Carolina: Parlor Press; 2010.
Ranganathan P, Aggarwal R. Study designs: Part 1 – An overview and classification. Perspect Clin Res. 2018;9(4):184–6. https://doi.org/10.4103/picr.PICR_124_18
Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet Lond Engl. 2002;359(9300):57–61. https://doi.org/10.1016/S0140-6736(02)07283-5
Torales J. Pirámide de la Evidencia y Tipos de Diseño de Investigación. Universidad Nacional de Asunción; 2023; San Lorenzo.
Universidad de Valencia. Diseño de tipo de estudios 2023. URL.
Aggarwal R, Ranganathan P. Study designs: Part 4 – Interventional studies. Perspect Clin Res. 2019;10(3):137–9. https://doi.org/10.4103/picr.PICR_91_19
Schulz KF, Chalmers I, Grimes DA, Altman DG. Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals. JAMA. 1994;272(2):125–8. URL.
Ranganathan P, Aggarwal R. Study designs: Part 3 - Analytical observational studies. Perspect Clin Res. 2019;10(2):91–4. https://doi.org/10.4103/picr.PICR_35_19
Aggarwal R, Ranganathan P. Study designs: Part 2 – Descriptive studies. Perspect Clin Res. 2019;10(1):34–6. https://doi.org/10.4103/picr.PICR_154_18
Argimón Pallás JM, Jiménez Villa J. Méodos de investigación clínica y epidemiológica. Barcelona: Elsevier España; 2010.
Zurita-Cruz JN, Márquez-González H, Miranda-Novales G, Villasís-Keever MÁ, Zurita-Cruz JN, Márquez-González H, et al. Estudios experimentales: diseños de investigación para la evaluación de intervenciones en la clínica. Rev Alerg México. 2018;65(2):178–86. https://doi.org/10.29262/ram.v65i2.376
Canadian Task Force on the Periodic Health Examination. The Canadian guide to clinical preventive care. Ottowa: Minister of Supply and Services Canada; 1994.
Torales J, Cuenca-Torres O, Barrios L, Armoa-Garcia L, Estigarribia G, Sanabria G, et al. An evaluation of the safety and immunogenicity of MVC-COV1901: Results of an interim analysis of a phase III, parallel group, randomized, double-blind, active-controlled immunobridging study in Paraguay. Vaccine. 2023;41(1):109–18. https://doi.org/10.1016/j.vaccine.2022.10.030
Manterola C, Quiroz G, Salazar P, García N. Metodología de los tipos y diseños de estudio más frecuentemente utilizados en investigación clínica. Rev Médica Clínica Las Condes. 2019;30(1):36–49. https://doi.org/10.1016/j.rmclc.2018.11.005
Langohr K. Sesgo de selección. Med Clínica Práctica. 2021;4(S2):1002992. https://doi.org/10.1016/j.mcpsp.2021.100299
Manterola C, Otzen T. Los Sesgos en Investigación Clínica. Int J Morphol. 2015;33(3):1156–64. https://doi.org/10.4067/S0717-95022015000300056
Quispe AM, Alvarez-Valdivia MG, Loli-Guevara S, Quispe AM, Alvarez-Valdivia MG, Loli-Guevara S. Metodologías Cuantitativas 2: Sesgo de confusión y cómo controlar un confusor. Rev Cuerpo Méd Hosp Nac Almanzor Aguinaga Asenjo. 2020;13(2):205–12. https://doi.org/10.35434/rcmhnaaa.2020.132.675
Harris AD, McGregor JC, Perencevich EN, Furuno JP, Zhu J, Peterson DE, et al. The Use and Interpretation of Quasi-Experimental Studies in Medical Informatics. J Am Med Inform Assoc JAMIA. 2006;13(1):16–23. https://doi.org/10.1197/jamia.M1749
Schmidt W-P. Randomised and non-randomised studies to estimate the effect of community-level public health interventions: definitions and methodological considerations. Emerg Themes Epidemiol. 2017;14:9. https://doi.org/10.1186/s12982-017-0063-5
Arnold BF, Khush RS, Ramaswamy P, London AG, Rajkumar P, Ramaprabha P, et al. Causal inference methods to study nonrandomized, preexisting development interventions. Proc Natl Acad Sci U S A. 2010;107(52):22605–10. https://doi.org/10.1073/pnas.1008944107
Little RJ, Rubin DB. Causal effects in clinical and epidemiological studies via potential outcomes: concepts and analytical approaches. Annu Rev Public Health. 2000;21:121–45. https://doi.org/10.1146/annurev.publhealth.21.1.121
Universitat Oberta de Catalunya. Estudios cuasiexperimentales. 2023. URL.
Almirón M, Barrios I. Valoración funcional de pacientes con lesiones del miembro superior a través del cuestionario DASHe. Med Clínica Soc. 2018;2(3):136–44. https://doi.org/10.52379/mcs.v2i3.66
Tosetto A, Testa S, Martinelli I, Poli D, Cosmi B, Lodigiani C, et al. External validation of the DASH prediction rule: a retrospective cohort study. J Thromb Haemost. 2017;15(10):1963–70. https://doi.org/10.1111/jth.13781
Lazcano G, Papuzinski C, Madrid E, Arancibia M. General concepts in biostatistics and clinical epidemiology: observational studies with cohort design. Medwave. 2019;19(11):e7748. https://doi.org/10.5867/medwave.2019.11.7748
Manterola C, Otzen T. Estudios Observacionales: Los Diseños Utilizados con Mayor Frecuencia en Investigación Clínica. Int J Morphol. 2014;32(2):634–45. https://doi.org/10.4067/S0717-95022014000200042
Hulley SB, editor. Designing clinical research. 4th ed. Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins; 2013.
Salazar F. P, Manterola D. C, Quiroz S. G, García M. N, Otzen H. T, Mora V. M, et al. Estudios de cohortes. 1a parte. Descripción, metodología y aplicaciones. Rev Cir. 2019;71(5):482–93. https://doi.org/10.35687/s2452-45492019005431
Ismael F, Bizario JCS, Battagin T, Zaramella B, Leal FE, Torales J, et al. Post-infection depressive, anxiety and post-traumatic stress symptoms: A prospective cohort study in patients with mild COVID-19. Prog Neuropsychopharmacol Biol Psychiatry. 2021;111:110341. https://doi.org/10.1016/j.pnpbp.2021.110341
Klebanoff MA, Snowden JM. Historical (retrospective) cohort studies and other epidemiologic study designs in perinatal research. Am J Obstet Gynecol. 2018;219(5):447–50. https://doi.org/10.1016/j.ajog.2018.08.044
Talavera JO, Rivas-Ruiz R. Clinical research XI. From the clinical judgment to the case and controls design. Rev Medica Inst Mex Seguro Soc. 2012;50(5):505–10
Sequera VG, Aguirre S, Estigarribia G, Cellamare M, Croda J, Andrews JR, et al. Increased incarceration rates drive growing tuberculosis burden in prisons and jeopardize overall tuberculosis control in Paraguay. Sci Rep. 2020;10:21247. https://doi.org/10.1038/s41598-020-77504-1
García-M. N, Manterola-D. C, Guerrero-Q. E, Navarrete-F. O, García-M. N, Manterola-D. C, et al. Estudios de cohortes especiales. Rev Cir. 2020;72(2):171–8. https://doi.org/10.35687/s2452-45492020002690
Molina Arias M, Ochoa Sangrador C. Estudios observacionales (II). Estudios de cohortes. Evid En Pediatría Asoc Esp Pediatría. 2014;10:14. URL.
Tamargo Barbeito TO, Gutiérrez Rojas ÁR, Quesada Peña S, López León N, Hidalgo Costa T, Tamargo Barbeito TO, et al. Algunas consideraciones sobre aplicación, cálculo e interpretación de odds ratio y riesgo relativo. Rev Cuba Med. 2019;58(3):e497. URL.
Moreno-Altamirano A, López-Moreno S, Corcho-Berdugo A. Principales medidas en epidemiología. Salud Pública México. 2000;42:337–48. URL.
Donis JH. Tipos de diseños de los estudios clínicos y epidemiológicos. Av En Biomed. 2013;2(2):76–99. URL.
Torales J, Barrios I, Amadeo G, Ebner B, Figueredo V, Garbett M, et al. Satisfacción corporal en bailarinas y no bailarinas. Mem Inst Investig En Cienc Salud. 2017;15(2):79–84. URL.
Sedgwick P. Nested case-control studies: advantages and disadvantages. BMJ. 2014;348:g1532. https://doi.org/10.1136/bmj.g1532
Sedgwick P. Selection bias versus allocation bias. BMJ. 2013;346:f3345. https://doi.org/10.1136/bmj.f3345
Sedgwick P. Re: What is recall bias? 2012;2012(344):e3519. URL.
Ranganathan P, Aggarwal R, Pramesh CS. Common pitfalls in statistical analysis: Odds versus risk. Perspect Clin Res. 2015;6(4):222–4. https://doi.org/10.4103/2229-3485.167092
Szumilas M. Explaining Odds Ratios. J Can Acad Child Adolesc Psychiatry. 2010;19(3):227–9
Gómez MG-, Danglot-Banck C, Alvarado SGH, Torre GG de la. El estudio de casos y controles: su diseño, análisis e interpretación, en investigación clínica. Rev Mex Pediatría. 2003;70(5):257–63. URL.
Ranganathan P. Understanding Research Study Designs. Indian J Crit Care Med. 2019;23(S4):S305–7. https://doi.org/10.5005/jp-journals-10071-23314
Cataldo R, Arancibia M, Stojanova J, Papuzinski C. General concepts in biostatistics and clinical epidemiology: Observational studies with cross-sectional and ecological designs. Medwave. 2019;19(8):e7698. https://doi.org/10.5867/medwave.2019.08.7698
Torales J, Barrios I, O’Higgins M, Almirón-Santacruz J, Gonzalez-Urbieta I, García O, et al. COVID-19 infodemic and depressive symptoms: The impact of the exposure to news about COVID-19 on the general Paraguayan population. J Affect Disord. 2022;298:599–603. https://doi.org/10.1016/j.jad.2021.11.036
Alexander L, Lopes B, Ricchetti-Masterson K, Yeatts K. Ecologic Studies. 2nd ed. 2015. 5 p. (ERIC Notebook).
Molodynski A, Lewis T, Kadhum M, Farrell SM, Lemtiri Chelieh M, Falcão De Almeida T, et al. Cultural variations in wellbeing, burnout and substance use amongst medical students in twelve countries. Int Rev Psychiatry. 2021;33(1–2):37–42. https://doi.org/10.1080/09540261.2020.1738064
Estigarribia G, Sequera G, Aguirre S, Méndez J, dos Santos PCP, Gustafson NW, et al. Phylogeography and transmission of Mycobacterium tuberculosis spanning prisons and surrounding communities in Paraguay. Nat Commun. 2023 Jan 19;14(1):303. https://doi.org/10.1038/s41467-023-35813-9
Torales J, Barrios I, Melgarejo O, Tullo-Gómez JE, Díaz NR, O’Higgins M, et al. Suicides among adults in Paraguay: An 18-year national exploratory study (2004–2022). Int J Soc Psychiatry. 2023;002076402311696. https://doi.org/10.1177/00207640231169650
Torales J, Barrios I, Tullo-Gómez JE, Melgarejo O, Gómez N, Riego V, et al. Suicides among Children and Adolescents in Paraguay: An 18-year National Exploratory Study (2004-2022). Int J Soc Psychiatry. 2023;207640231169656. https://doi.org/10.1177/00207640231169656
World Health Organization. The ICD-10 classification of mental and behavioural disorders. 2019. URL.
Dagnino S. J. Correlación. Rev Chil Anest. 2014;43(2):150–3. https://doi.org/10.25237/revchilanestv43n02.15
Diez Roux AV. La necesidad de un enfoque multinivel en epidemiología. Región Soc. 2008;20(SPE2):77–91. URL.
Romaní FR. Reporte de caso y serie de casos: una aproximación para el pregrado. CIMEL Cienc E Investig Médica Estud Latinoam. 2010;15(1):46–51. URL.
Albrecht J, Meves A, Bigby M. Case reports and case series from Lancet had significant impact on medical literature. J Clin Epidemiol. 2005;58(12):1227–32. https://doi.org/10.1016/j.jclinepi.2005.04.003
Torales J, Barrios I, García Franco O, López Ruiz RD. Características de pacientes con diagnóstico de primer episodio psicótico internados en un hospital universitario. Rev Virtual Soc Paraguaya Med Interna. 2020;7(2):34–40. https://doi.org/10.18004/rvspmi/2312-3893/2020.07.02.34
Moreno-Leiva C, Estigarribia G, Pereira JB, Méndez J, Silva FD, Montaya C, et al. Serie de Casos de Leishmaniasis Detectados en Centros Hospitalarios del Departamento de Caaguazú, Paraguay en 2019. Rev Inst Med Trop. 2021;16(1):44–54. https://doi.org/10.18004/imt/2021.16.1.44
De Doménico E, Castaldelli-Maia JM, Ventriglio A, Torales J. Diagnostic Stability of Major Depressive Disorder in hospitalized patients in a University Hospital: a Brief Report. Med Clínica Soc. 2021;5(3):141–4. https://doi.org/10.52379/mcs.v5i3.223
Kendell RE. The Stability of Psychiatric Diagnoses. Br J Psychiatry. 1974;124(581):352–6. https://doi.org/10.1192/bjp.124.4.352
Sánchez R, Jaramillo LE, Quintero C. Estabilidad del diagnóstico psiquiátrico en pacientes de consulta externa. Rev Colomb Psiquiatr. 2002;XXXI(2):91–112. URL.
Hoyer A, Zapf A. Studies for the Evaluation of Diagnostic Tests. Dtsch Ärztebl Int. 2021;118(33–34):555–60. https://doi.org/10.3238/arztebl.m2021.0224
Schlenger RL. PCR-Tests auf SARS-CoV-2: Ergebnisse richtig interpretieren. Dtsch Arztebl. 2020;117(24):1194. URL.
Servicio Gallego de Salud. Pruebas diagnósticas. Ayuda de Epidat. 2016.
Torregroza-Diazgranados E de J. Pruebas diagnósticas: Fundamentos de los estudios diagnósticos, evaluación de la validez e interpretación clínica de sus resultados. Rev Colomb Cir. 2021;36(2):193–204. https://doi.org/10.30944/20117582.716
Jaimes F. Pruebas diagnósticas: uso e interpretación. Acta Medica Colomb. 2007;32(1):29–33. URL.
Fescina RH, Forestieri OÁ, Uranga A. Evaluación de los procedimientos diagnósticos. Universidad Nacional de La Plata (UNLP); 2022.
Griner PF, Mayewski RJ, Mushlin AI, Greenland P. Selection and interpretation of diagnostic tests and procedures. Principles and applications. Ann Intern Med. 1981;94(4 Pt 2):557–92. URL.
Silva Ayçaguer LC. Métodos estadísticos para la investigación epidemiológica. Instituto Vasco de Estadística; 1988.
Shaughnessy AF. Clinical Epidemiology: A Basic Science for Clinical Medicine. BMJ. 2007;335(7623):777. https://doi.org/10.1136/bmj.39349.461678.43
Feinstein AR. Clinical epidemiology: the architecture of clinical research. Philadelphia: W.B. Saunders Co; 1985. 812 p.
Gmurman V. Teoría y problemas de las probabilidades y estadística matemática. Moscú Editor MiL. 1974.
Kwiecien R, Kopp-Schneider A, Blettner M. Concordance Analysis. Dtsch Ärztebl Int. 2011;108(30):515–21. https://doi.org/10.3238/arztebl.2011.0515
Kumar R. Research methodology: a step-by-step guide for beginners. 3rd ed. Los Angeles: SAGE; 2011. 415 p.
Rothman KJ, Greenland S, Lash TL. Types of epidemiologic studies. In: Modern epidemiology. 3rd ed. Philadelphia: Wolters Kluwer Health/Lippincott Williams & Wilkins Philadelphia; 2008. p. 87–99.
Ho PM, Peterson PN, Masoudi FA. Evaluating the evidence: is there a rigid hierarchy? Circulation. 2008;118(16):1675–84. https://doi.org/10.1161/CIRCULATIONAHA.107.721357
Kothari C. Research methodology methods and techniques by CR Kothari. Publ New Age Int P Ltd Publ. 2017;91.
Gupta S, Institute of Clinical Research (India). Basic principles of clinical research and methodology. New Delhi: Jaypee Brothers Pub; 2009.
Jokstad A. Please do not feel bad, identifying the precise study design used in clinical research may be a challenge. Clin Exp Dent Res. 2019;5(3):181–3. https://doi.org/10.1002/cre2.211
Celentano DD, Szklo M, Gordis L. Gordis epidemiology. 6th edition. Philadelphia, PA: Elsevier; 2019. 420 p.
Trochim WM. Research methods: The concise knowledge base. Cincinnati: Atomic Dog Publishing; 2005.
Valencia LIVI. La lógica y la importancia del diseño de investigación. Poiésis. 2011;(22):1–14. https://doi.org/10.21501/16920945.217
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