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Methodological notes
Medwave 2019;19(10):e7716 doi: 10.5867/medwave.2019.10.7716
General concepts in biostatistics and clinical epidemiology: observational studies with case-control design
Diego Martínez, Cristian Papuzinski, Jana Stojanova, Marcelo Arancibia
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Key Words: observational study, case-control studies, bias, epidemiology, biostatistics

Abstract

Case-control studies have been essential to the field of epidemiology and in public health research. In this design, data analysis is carried out from the outcome to the exposure, that is, retrospectively, as the association between exposure and outcome is studied between people who present a condition (cases) and those who do not (controls). They are thus very useful for studying infrequent conditions, or for those that involve a long latency period. There are different case selection methodologies, but the central aspect is the selection of controls. Data collection can be retrospective (obtained from clinical records) or prospective (applying data collection instruments to participants). Depending on the objective of the study, different types of case-control studies are available; however, all present a particular vulnerability to information bias and confounding, which can be controlled at the level of design and in the statistical analysis. This review addresses general theoretical concepts concerning case-control studies, including their historical development, methods for selecting participants, types of case-control studies, association measures, potential biases, as well as their advantages and disadvantages. Finally, concepts about the relevance on this study design are discussed, with a view to aid comprehension for undergraduate and graduate students of the health sciences. This is the third of a methodological series of articles on general concepts in biostatistics and clinical epidemiology developed by the Chair of Scientific Research Methodology at the School of Medicine, University of Valparaíso, Chile.


 

The English version is in the process of being published.


Licencia Creative Commons Esta obra de Medwave está bajo una licencia Creative Commons Atribución-NoComercial 3.0 Unported. Esta licencia permite el uso, distribución y reproducción del artículo en cualquier medio, siempre y cuando se otorgue el crédito correspondiente al autor del artículo y al medio en que se publica, en este caso, Medwave.

 

Los estudios de casos y controles han sido esenciales en el desarrollo de la epidemiología y de la salud pública. En este diseño, el análisis de los datos se realiza desde el desenlace hacia la exposición, es decir, retrospectivamente, ya que se estudia la asociación entre factores de exposición y un desenlace conocido entre personas que ya presentan una condición (casos) y quienes no la presentan (controles). Por lo tanto, son muy útiles en condiciones infrecuentes o que requieren una larga latencia para ocurrir. Existen distintas metodologías de selección de casos, pero el aspecto central es la adecuada selección de controles. La recolección de los datos puede ser retrospectiva (desde de registros clínicos) o prospectiva (mediante la aplicación de instrumentos de recolección de datos a los participantes). En función del objetivo del estudio, se dispone de distintos tipos de estudios de casos y controles, pero todos presentan una vulnerabilidad particular al sesgo de información y de confusión, los que pueden controlarse a nivel del diseño y del análisis estadístico. En este artículo se abordan conceptos teóricos generales sobre los estudios de casos y controles, considerando aspectos históricos, metodología de selección de participantes, tipos estudios de casos y controles, medidas de asociación, potenciales sesgos, ventajas y desventajas. Finalmente, se discuten algunos conceptos de relevancia sobre este diseño para los estudiantes de pre y posgrado de ciencias de la salud. Esta revisión es la tercera entrega de una serie metodológica sobre conceptos generales en bioestadística y epidemiología clínica desarrollada por la Cátedra de Metodología de la Investigación Científica de la Escuela de Medicina de la Universidad de Valparaíso, Chile.

Authors: Diego Martínez[1], Cristian Papuzinski[1,2], Jana Stojanova[1,2], Marcelo Arancibia[1,2]

Affiliation:
[1] Cátedra de Metodología de la Investigación Científica, Escuela de Medicina, Universidad de Valparaíso, Viña del Mar, Chile
[2] Centro Interdisciplinario de Estudios en Salud (CIESAL), Universidad de Valparaíso, Valparaíso, Chile

E-mail: marcelo.arancibiame@uv.c

Citation: Martínez D, Papuzinski C, Stojanova J, Arancibia M. General concepts in biostatistics and clinical epidemiology: observational studies with case-control design. Medwave 2019;19(10):e7716 doi: 10.5867/medwave.2019.10.7716

Submission date: 10/9/2019

Acceptance date: 25/10/2019

Publication date: 11/11/2019

Origin: This article is one of several “Methodological notes” prepared by the course on Research Methodology of the School of Medicine of the University of Valparaíso

Type of review: reviewed by three external peer reviewers, double-blind

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  1. Paneth N, Susser E, Susser M. Origins and early development of the case-control study: Part 1, Early evolution. Soz Praventivmed. 2002;47(5):282-8. | CrossRef | PubMed |
  2. Shiode N, Shiode S, Rod-Thatcher E, Rana S, Vinten-Johansen P. The mortality rates and the space-time patterns of John Snow's cholera epidemic map. Int J Health Geogr. 2015 Jun 17;14:21. | CrossRef | PubMed |
  3. Paneth N. Assessing the contributions of John Snow to epidemiology: 150 years after removal of the broad street pump handle. Epidemiology. 2004 Sep;15(5):514-6. | CrossRef | PubMed |
  4. Lane-Claypon J. A further report on cancer of the breast. In: Reports on public health and medical subjects. London: Ministry of Health; 1926. | Link |
  5. Müller F. Tabakmissbrauch und Lungencarzinom. Ztschr Krebforsch. 1939;49:57-85.
  6. Paneth N, Susser E, Susser M. Origins and early development of the case-control study: Part 2, The case-control study from Lane-Claypon to 1950. Soz Praventivmed. 2002;47(6):359-65. | PubMed |
  7. Doll R, Hill AB. Smoking and carcinoma of the lung; preliminary report. Br Med J. 1950 Sep 30;2(4682):739-48. | CrossRef | PubMed |
  8. Franceschi S. Sir Richard Doll. Salud Publica Mex. 2006;48 Suppl 1:S217-8. | CrossRef | PubMed |
  9. Moss AR, Osmond D, Bacchetti P, Chermann JC, Barre-Sinoussi F, Carlson J. Risk factors for AIDS and HIV seropositivity in homosexual men. Am J Epidemiol. 1987 Jun;125(6):1035-47. | PubMed |
  10. Papuzinski C, Martínez F. Case-control studies – the retrospective perspective. Medwave. 2014 Mar 27;14(2):e5925. | CrossRef | PubMed |
  11. Araujo M. Etiology and prognostic clinical trials. Medwave 2011 Jun;11(06):e5052. | CrossRef |
  12. Sackett D, Haynes R, Guyatt G, Tugwell P. Clinical epidemiology: a basic science for clinical medicine. 2nd ed. Boston: Little Brown and Company; 1991. | Link |
  13. Araujo M. The temporality of clinical trials. Medwave 2011 May;11(05):e5020. | CrossRef |
  14. Schulz KF, Grimes DA. Case-control studies: research in reverse. Lancet. 2002 Feb 2;359(9304):431-4. | PubMed |
  15. Lazcano-Ponce E, Salazar-Martínez E, Hernández-Ávila M. Estudios epidemiológicos de casos y controles. Fundamento teórico, variantes y aplicaciones. Salud Pública Mex. 2001;43(2):135-50. | Link |
  16. Gómez-Restrepo C. Estudios de casos y controles. In: Ruiz Á, Gómez-Restrepo C, editors. Epidemiología clínica: investigación clínica aplicada. 2nd ed. Bogotá: Editorial Médica Panamericana; 2015.
  17. Grimes DA, Schulz KF. Compared to what? Finding controls for case-control studies. Lancet. 2005 Apr 16-22;365(9468):1429-33. | PubMed |
  18. Langholz B, Richardson D. Are nested case-control studies biased? Epidemiology. 2009 May;20(3):321-9. | CrossRef | PubMed |
  19. Kumar A, Dogra S, Kaur A, Modi M, Thakur A, Saluja S. Approach to sample size calculation in medical research. Curr Med Res Pract. 2014 Mar 1;4(2):87-92. | CrossRef |
  20. Wacholder S, McLaughlin JK, Silverman DT, Mandel JS. Selection of controls in case-control studies. I. Principles. Am J Epidemiol. 1992 May 1;135(9):1019-28. | PubMed |
  21. Viera AJ. Odds ratios and risk ratios: what's the difference and why does it matter? South Med J. 2008 Jul;101(7):730-4. | CrossRef | PubMed |
  22. Maclure M. The case-crossover design: a method for studying transient effects on the risk of acute events. Am J Epidemiol. 1991 Jan 15;133(2):144-53. | PubMed |
  23. Molina-Arias M. Estudios de casos cruzados. Rev Pediatr Aten Primaria. 2015 Dec;17(68):373-6. | Link |
  24. Lombardi DA. The case-crossover study: a novel design in evaluating transient fatigue as a risk factor for road traffic accidents. Sleep. 2010 Mar;33(3):283-4. | PubMed |
  25. Molina-Arias M. Diseños híbridos. Rev Pediatr Aten Primaria. 2016;18:8993. | Link |
  26. Manterola C, Otzen T. Los Sesgos en Investigación Clínica. Int J Morphol [Internet]. 2015 Sep;33(3):1156-64. | Link |
  27. Grimes DA, Schulz KF. Bias and causal associations in observational research. Lancet. 2002 Jan 19;359(9302):248-52. | PubMed |
  28. García Marcos L, Guillén Pérez J, Orejas Rodríguez-Arango G. Epidemiología y metodología aplicada a la pediatría (V): Sesgos. An Esp Pediatr. 1999;50:519-524. | Link |
  29. Barraza F, Arancibia M, Madrid E, Papuzinski C. General concepts in biostatistics and clinical epidemiology: Random error and systematic error. Medwave. 2019 Aug 27;19(7):e7687. | CrossRef | PubMed |
  30. 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 Sep 25;19(8):e7698. | CrossRef | PubMed |
  31. Araujo M. Confusion in clinical studies. Medwave 2012 May;12(4):e5349. | CrossRef |
  32. Rose S, Laan MJ van der. Why match? Investigating matched case-control study designs with causal effect estimation. Int J Biostat. 2009 Jan 6;5(1):Article 1. | CrossRef |
  33. Mansournia MA, Jewell NP, Greenland S. Case–control matching: effects, misconceptions, and recommendations. Eur J Epidemiol. 2018 Jan 3;33(1):5-14. | CrossRef |
  34. Hidalgo B, Goodman M. Multivariate or multivariable regression? Am J Public Health [Internet]. 2013 Jan [cited 2019 Jul 22];103(1):39–40. | CrossRef | PubMed |
  35. Lu CY. Observational studies: a review of study designs, challenges and strategies to reduce confounding. Int J Clin Pract. 2009 May;63(5):691-7. | CrossRef |
  36. Rosenbaum PR, Rubin DB. Reducing Bias in Observational Studies Using Subclassification on the Propensity Score. J Am Stat Assoc . 1984 Sep;79(387):516–24. | CrossRef |
  37. Ghaemi S. Why you cannot believe your eyes: the three C’s. In: A clinician’s guide to statistics and epidemiology in mental health: measuring truth and uncertainty. Cambridge: Cambridge University Press; 2009.
  38. Perillo MG. Choice of controls in case-control studies. J Manipulative Physiol Ther. 1993 Nov-Dec;16(9):578-85. | PubMed |
  39. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med. 2007 Oct 16;4(10):e296. | CrossRef | PubMed |
  40. Silva Ayçaguer LC. [Causality and prediction: differences and points of contact]. Medwave. 2014 Sep 10;14(8):e6016. | CrossRef | PubMed |
Paneth N, Susser E, Susser M. Origins and early development of the case-control study: Part 1, Early evolution. Soz Praventivmed. 2002;47(5):282-8. | CrossRef | PubMed |

Shiode N, Shiode S, Rod-Thatcher E, Rana S, Vinten-Johansen P. The mortality rates and the space-time patterns of John Snow's cholera epidemic map. Int J Health Geogr. 2015 Jun 17;14:21. | CrossRef | PubMed |

Paneth N. Assessing the contributions of John Snow to epidemiology: 150 years after removal of the broad street pump handle. Epidemiology. 2004 Sep;15(5):514-6. | CrossRef | PubMed |

Lane-Claypon J. A further report on cancer of the breast. In: Reports on public health and medical subjects. London: Ministry of Health; 1926. | Link |

Müller F. Tabakmissbrauch und Lungencarzinom. Ztschr Krebforsch. 1939;49:57-85.

Paneth N, Susser E, Susser M. Origins and early development of the case-control study: Part 2, The case-control study from Lane-Claypon to 1950. Soz Praventivmed. 2002;47(6):359-65. | PubMed |

Doll R, Hill AB. Smoking and carcinoma of the lung; preliminary report. Br Med J. 1950 Sep 30;2(4682):739-48. | CrossRef | PubMed |

Franceschi S. Sir Richard Doll. Salud Publica Mex. 2006;48 Suppl 1:S217-8. | CrossRef | PubMed |

Moss AR, Osmond D, Bacchetti P, Chermann JC, Barre-Sinoussi F, Carlson J. Risk factors for AIDS and HIV seropositivity in homosexual men. Am J Epidemiol. 1987 Jun;125(6):1035-47. | PubMed |

Papuzinski C, Martínez F. Case-control studies – the retrospective perspective. Medwave. 2014 Mar 27;14(2):e5925. | CrossRef | PubMed |

Araujo M. Etiology and prognostic clinical trials. Medwave 2011 Jun;11(06):e5052. | CrossRef |

Sackett D, Haynes R, Guyatt G, Tugwell P. Clinical epidemiology: a basic science for clinical medicine. 2nd ed. Boston: Little Brown and Company; 1991. | Link |

Araujo M. The temporality of clinical trials. Medwave 2011 May;11(05):e5020. | CrossRef |

Schulz KF, Grimes DA. Case-control studies: research in reverse. Lancet. 2002 Feb 2;359(9304):431-4. | PubMed |

Lazcano-Ponce E, Salazar-Martínez E, Hernández-Ávila M. Estudios epidemiológicos de casos y controles. Fundamento teórico, variantes y aplicaciones. Salud Pública Mex. 2001;43(2):135-50. | Link |

Gómez-Restrepo C. Estudios de casos y controles. In: Ruiz Á, Gómez-Restrepo C, editors. Epidemiología clínica: investigación clínica aplicada. 2nd ed. Bogotá: Editorial Médica Panamericana; 2015.

Grimes DA, Schulz KF. Compared to what? Finding controls for case-control studies. Lancet. 2005 Apr 16-22;365(9468):1429-33. | PubMed |

Langholz B, Richardson D. Are nested case-control studies biased? Epidemiology. 2009 May;20(3):321-9. | CrossRef | PubMed |

Kumar A, Dogra S, Kaur A, Modi M, Thakur A, Saluja S. Approach to sample size calculation in medical research. Curr Med Res Pract. 2014 Mar 1;4(2):87-92. | CrossRef |

Wacholder S, McLaughlin JK, Silverman DT, Mandel JS. Selection of controls in case-control studies. I. Principles. Am J Epidemiol. 1992 May 1;135(9):1019-28. | PubMed |

Viera AJ. Odds ratios and risk ratios: what's the difference and why does it matter? South Med J. 2008 Jul;101(7):730-4. | CrossRef | PubMed |

Maclure M. The case-crossover design: a method for studying transient effects on the risk of acute events. Am J Epidemiol. 1991 Jan 15;133(2):144-53. | PubMed |

Molina-Arias M. Estudios de casos cruzados. Rev Pediatr Aten Primaria. 2015 Dec;17(68):373-6. | Link |

Lombardi DA. The case-crossover study: a novel design in evaluating transient fatigue as a risk factor for road traffic accidents. Sleep. 2010 Mar;33(3):283-4. | PubMed |

Molina-Arias M. Diseños híbridos. Rev Pediatr Aten Primaria. 2016;18:8993. | Link |

Manterola C, Otzen T. Los Sesgos en Investigación Clínica. Int J Morphol [Internet]. 2015 Sep;33(3):1156-64. | Link |

Grimes DA, Schulz KF. Bias and causal associations in observational research. Lancet. 2002 Jan 19;359(9302):248-52. | PubMed |

García Marcos L, Guillén Pérez J, Orejas Rodríguez-Arango G. Epidemiología y metodología aplicada a la pediatría (V): Sesgos. An Esp Pediatr. 1999;50:519-524. | Link |

Barraza F, Arancibia M, Madrid E, Papuzinski C. General concepts in biostatistics and clinical epidemiology: Random error and systematic error. Medwave. 2019 Aug 27;19(7):e7687. | CrossRef | PubMed |

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 Sep 25;19(8):e7698. | CrossRef | PubMed |

Araujo M. Confusion in clinical studies. Medwave 2012 May;12(4):e5349. | CrossRef |

Rose S, Laan MJ van der. Why match? Investigating matched case-control study designs with causal effect estimation. Int J Biostat. 2009 Jan 6;5(1):Article 1. | CrossRef |

Mansournia MA, Jewell NP, Greenland S. Case–control matching: effects, misconceptions, and recommendations. Eur J Epidemiol. 2018 Jan 3;33(1):5-14. | CrossRef |

Hidalgo B, Goodman M. Multivariate or multivariable regression? Am J Public Health [Internet]. 2013 Jan [cited 2019 Jul 22];103(1):39–40. | CrossRef | PubMed |

Lu CY. Observational studies: a review of study designs, challenges and strategies to reduce confounding. Int J Clin Pract. 2009 May;63(5):691-7. | CrossRef |

Rosenbaum PR, Rubin DB. Reducing Bias in Observational Studies Using Subclassification on the Propensity Score. J Am Stat Assoc . 1984 Sep;79(387):516–24. | CrossRef |

Ghaemi S. Why you cannot believe your eyes: the three C’s. In: A clinician’s guide to statistics and epidemiology in mental health: measuring truth and uncertainty. Cambridge: Cambridge University Press; 2009.

Perillo MG. Choice of controls in case-control studies. J Manipulative Physiol Ther. 1993 Nov-Dec;16(9):578-85. | PubMed |

von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med. 2007 Oct 16;4(10):e296. | CrossRef | PubMed |

Silva Ayçaguer LC. [Causality and prediction: differences and points of contact]. Medwave. 2014 Sep 10;14(8):e6016. | CrossRef | PubMed |