Tutorials in Clinical Research: Part IV: Recognizing and Controlling Bias

Objective This is the fourth of a series of Tutorials in Clinical Research. 1–3 The objectives of this article are to heighten reader awareness of biases and of methods to reduce their impact and to provide an easy reference document for the reader during future journal reading. Study Design Tutoria...

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Published in:	The Laryngoscope Vol. 112; no. 1; pp. 23 - 31
Main Authors:	Hartman, James M., Forsen Jr, James W., Wallace, Mark S., Neely, J. Gail
Format:	Journal Article
Language:	English
Published:	Hoboken, NJ John Wiley & Sons, Inc 01.01.2002 Wiley-Blackwell
Subjects:	Bias Bias (Epidemiology) Biological and medical sciences Case-Control Studies clinical protocols Cohort Studies confounding factors Curriculum Education, Medical, Continuing Humans Medical sciences Miscellaneous Otolaryngology - education Public health. Hygiene Public health. Hygiene-occupational medicine Publication Bias Randomized Controlled Trials as Topic - statistics & numerical data research design research/methods United States North America America Design Human Reading Scientific research Article Scientific communication Clinical trial Methodological bias Review Experimental protocol Public health Recommendation
ISSN:	0023-852X, 1531-4995
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Abstract	Objective This is the fourth of a series of Tutorials in Clinical Research. 1–3 The objectives of this article are to heighten reader awareness of biases and of methods to reduce their impact and to provide an easy reference document for the reader during future journal reading. Study Design Tutorial. Methods The authors met weekly for 4 months discussing clinical research articles and biases for which they might be at risk. Liberal use of reference texts and specific articles on bias were reviewed. Like the example by Sackett, biases were catalogued to create an easily understood reference. Articles were chosen to demonstrate how understanding bias might facilitate assessment of the validity of medical publications. Results The article is organized into three main sections. The first section introduces specific biases. Two tables serve as rapid reference tools. The second section describes the most common biases linked to specific research approaches and reviews techniques to minimize them. The last section demonstrates the application of the information to an article in a manner that can be applied to any article. Conclusions Assessing the validity of a medical publication requires an awareness of bias for which the research is inherently at risk. A review of the publication to determine what steps the authors did or did not undertake to minimize the impact of biases on their results and conclusions helps establish the validity. This article should be of assistance in this critical review task.
AbstractList	This is the fourth of a series of Tutorials in Clinical Research (1-3). The objectives of this article are to heighten reader awareness of biases and of methods to reduce their impact and to provide an easy reference document for the reader during future journal reading.Tutorial.The authors met weekly for 4 months discussing clinical research articles and biases for which they might be at risk. Liberal use of reference texts and specific articles on bias were reviewed. Like the example by Sackett, biases were catalogued to create an easily understood reference. Articles were chosen to demonstrate how understanding bias might facilitate assessment of the validity of medical publications.The article is organized into three main sections. The first section introduces specific biases. Two tables serve as rapid reference tools. The second section describes the most common biases linked to specific research approaches and reviews techniques to minimize them. The last section demonstrates the application of the information to an article in a manner that can be applied to any article.Assessing the validity of a medical publication requires an awareness of bias for which the research is inherently at risk. A review of the publication to determine what steps the authors did or did not undertake to minimize the impact of biases on their results and conclusions helps establish the validity. This article should be of assistance in this critical review task. Objective This is the fourth of a series of Tutorials in Clinical Research. 1–3 The objectives of this article are to heighten reader awareness of biases and of methods to reduce their impact and to provide an easy reference document for the reader during future journal reading. Study Design Tutorial. Methods The authors met weekly for 4 months discussing clinical research articles and biases for which they might be at risk. Liberal use of reference texts and specific articles on bias were reviewed. Like the example by Sackett, biases were catalogued to create an easily understood reference. Articles were chosen to demonstrate how understanding bias might facilitate assessment of the validity of medical publications. Results The article is organized into three main sections. The first section introduces specific biases. Two tables serve as rapid reference tools. The second section describes the most common biases linked to specific research approaches and reviews techniques to minimize them. The last section demonstrates the application of the information to an article in a manner that can be applied to any article. Conclusions Assessing the validity of a medical publication requires an awareness of bias for which the research is inherently at risk. A review of the publication to determine what steps the authors did or did not undertake to minimize the impact of biases on their results and conclusions helps establish the validity. This article should be of assistance in this critical review task. This is the fourth of a series of Tutorials in Clinical Research (1-3). The objectives of this article are to heighten reader awareness of biases and of methods to reduce their impact and to provide an easy reference document for the reader during future journal reading. Tutorial. The authors met weekly for 4 months discussing clinical research articles and biases for which they might be at risk. Liberal use of reference texts and specific articles on bias were reviewed. Like the example by Sackett, biases were catalogued to create an easily understood reference. Articles were chosen to demonstrate how understanding bias might facilitate assessment of the validity of medical publications. The article is organized into three main sections. The first section introduces specific biases. Two tables serve as rapid reference tools. The second section describes the most common biases linked to specific research approaches and reviews techniques to minimize them. The last section demonstrates the application of the information to an article in a manner that can be applied to any article. Assessing the validity of a medical publication requires an awareness of bias for which the research is inherently at risk. A review of the publication to determine what steps the authors did or did not undertake to minimize the impact of biases on their results and conclusions helps establish the validity. This article should be of assistance in this critical review task. This is the fourth of a series of Tutorials in Clinical Research (1-3). The objectives of this article are to heighten reader awareness of biases and of methods to reduce their impact and to provide an easy reference document for the reader during future journal reading.OBJECTIVEThis is the fourth of a series of Tutorials in Clinical Research (1-3). The objectives of this article are to heighten reader awareness of biases and of methods to reduce their impact and to provide an easy reference document for the reader during future journal reading.Tutorial.STUDY DESIGNTutorial.The authors met weekly for 4 months discussing clinical research articles and biases for which they might be at risk. Liberal use of reference texts and specific articles on bias were reviewed. Like the example by Sackett, biases were catalogued to create an easily understood reference. Articles were chosen to demonstrate how understanding bias might facilitate assessment of the validity of medical publications.METHODSThe authors met weekly for 4 months discussing clinical research articles and biases for which they might be at risk. Liberal use of reference texts and specific articles on bias were reviewed. Like the example by Sackett, biases were catalogued to create an easily understood reference. Articles were chosen to demonstrate how understanding bias might facilitate assessment of the validity of medical publications.The article is organized into three main sections. The first section introduces specific biases. Two tables serve as rapid reference tools. The second section describes the most common biases linked to specific research approaches and reviews techniques to minimize them. The last section demonstrates the application of the information to an article in a manner that can be applied to any article.RESULTSThe article is organized into three main sections. The first section introduces specific biases. Two tables serve as rapid reference tools. The second section describes the most common biases linked to specific research approaches and reviews techniques to minimize them. The last section demonstrates the application of the information to an article in a manner that can be applied to any article.Assessing the validity of a medical publication requires an awareness of bias for which the research is inherently at risk. A review of the publication to determine what steps the authors did or did not undertake to minimize the impact of biases on their results and conclusions helps establish the validity. This article should be of assistance in this critical review task.CONCLUSIONSAssessing the validity of a medical publication requires an awareness of bias for which the research is inherently at risk. A review of the publication to determine what steps the authors did or did not undertake to minimize the impact of biases on their results and conclusions helps establish the validity. This article should be of assistance in this critical review task.
Author	Hartman, James M. Forsen Jr, James W. Neely, J. Gail Wallace, Mark S.
Author_xml	– sequence: 1 givenname: James M. surname: Hartman fullname: Hartman, James M. organization: Clinical Research Working Group, Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St. Louis, Missouri, U.S.A – sequence: 2 givenname: James W. surname: Forsen Jr fullname: Forsen Jr, James W. organization: Clinical Research Working Group, Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St. Louis, Missouri, U.S.A – sequence: 3 givenname: Mark S. surname: Wallace fullname: Wallace, Mark S. organization: Clinical Research Working Group, Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St. Louis, Missouri, U.S.A – sequence: 4 givenname: J. Gail surname: Neely fullname: Neely, J. Gail email: jgneely@aol.com organization: Clinical Research Working Group, Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St. Louis, Missouri, U.S.A
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References	Gotzsche P. Statistics in medicine. Reference bias in reports of drug trials. BMJ 1987; 295: 654-656. Rothman K. Modern Epidemiology. Boston/Toronto: Little, Brown & Co, 1986. Neely J. Clinical epidemiology/outcomes research. Literature review articles as a research form. Otolaryngol Head Neck Surg 1993; 108: 743-748. Feinstein AR. Clinical Epidemiology: The Architecture of Clinical Research. Philadelphia: W. B. Saunders Co, 1985. Thornton A. Publication bias in meta-analysis: its causes and consequences. J Clin Epidemiol 2000; 53: 207-216. Begg C. Biases in the assessment of diagnostic tests. Stat Med 1987; 6: 411-423. Neely JG, Hartman JM, Wallace MS. Tutorials in Clinical Research: building the powerful 10-minute office visit. Part II: beginning a critical literature review. Laryngoscope 2001; 111: 70-76. Maw A. Development of tympanosclerosis in children with otitis media with effusion and ventilation tubes. J Laryngol Otol 1991; 105: 614-617. Day J, Briscoe M, Clark R, Ellis A, Gervais P. Onset of action and efficacy of terfenadine, astemizole, cetirizine, and loratadine for the relief of symptoms of allergic rhinitis. Ann Allergy Asthma Immunol 1997; 79: 163-172. Adour K, Ruboyianes J, VonDoersten P, et al. Bell's palsy treatment with acyclovir and prednisone compared with prednisone along: a double-blind, randomized, controlled trial. Ann Otol Rhinol Laryngol 1996; 105: 371-378. Jacobsen S, Xia Z, Campion M, et al. Potential effect of authorization bias on medical record research. Mayo Clin Proc 1999; 74: 330-338. Neely JG, Hartman JM, Wallace MS, Forsen JW, Jr., Tutorials in Clinical Research: Part III: selecting a research approach to best answer a clinical question. Laryngoscope 2001; 111: 821-830. Ulualp S, Toohill R, Hoffman R, Shaker R. Pharyngeal pH monitoring in patients with posterior laryngitis. Otolaryngol Head Neck Surg 1999; 120: 672-677. Neely JG, Hartman JM, Wallace MS. Building the powerful 10-minute office visit. Part I: introduction to the new section. Laryngoscope 2000; 110: 1595-1601. Roberts R, Spitzer W, Delmore T, Sackett D. An empirical demonstration of Berkson's bias. J Chron Dis 1978; 31: 119-128. Maclure M, Schneeweiss S. Causation of bias: the episcope. Epidemiology 2001; 12: 114-122. Dickersin K. The existence of publication bias and risk factors for its occurrence. JAMA 1990; 263: 1385-1389. Chalmers TC, Frank CS, Reitman D. Minimizing the three stages of publication bias. JAMA 1990; 263: 1392-1395. Sackett D. Bias in analytic research. J Chron Dis 1979; 32: 51-63. Webster's Third New International. Dictionary of the English Language Unabridged. Chicago: Encyclopaedia Britanica, Inc, 1976. 2001; 111 1987; 295 1993; 108 1978; 31 1997; 79 1987; 6 2000; 53 1976 1999; 120 1986 1985 2000; 110 1993 1999; 74 2001; 12 1991; 105 1979; 32 1990; 263 1996; 105 Rothman K (e_1_2_3_22_2) 1986 Portney LG (e_1_2_3_9_2) 1993 e_1_2_3_19_2 e_1_2_3_15_2 e_1_2_3_4_2 e_1_2_3_16_2 e_1_2_3_3_2 e_1_2_3_17_2 e_1_2_3_2_2 e_1_2_3_18_2 e_1_2_3_11_2 e_1_2_3_8_2 e_1_2_3_12_2 e_1_2_3_7_2 e_1_2_3_13_2 e_1_2_3_14_2 Feinstein AR (e_1_2_3_6_2) 1985 Webster's Third New International (e_1_2_3_5_2) 1976 e_1_2_3_20_2 e_1_2_3_10_2 e_1_2_3_21_2
References_xml	– reference: Maclure M, Schneeweiss S. Causation of bias: the episcope. Epidemiology 2001; 12: 114-122. – reference: Thornton A. Publication bias in meta-analysis: its causes and consequences. J Clin Epidemiol 2000; 53: 207-216. – reference: Begg C. Biases in the assessment of diagnostic tests. Stat Med 1987; 6: 411-423. – reference: Rothman K. Modern Epidemiology. Boston/Toronto: Little, Brown & Co, 1986. – reference: Sackett D. Bias in analytic research. J Chron Dis 1979; 32: 51-63. – reference: Neely J. Clinical epidemiology/outcomes research. Literature review articles as a research form. Otolaryngol Head Neck Surg 1993; 108: 743-748. – reference: Adour K, Ruboyianes J, VonDoersten P, et al. Bell's palsy treatment with acyclovir and prednisone compared with prednisone along: a double-blind, randomized, controlled trial. Ann Otol Rhinol Laryngol 1996; 105: 371-378. – reference: Roberts R, Spitzer W, Delmore T, Sackett D. An empirical demonstration of Berkson's bias. J Chron Dis 1978; 31: 119-128. – reference: Ulualp S, Toohill R, Hoffman R, Shaker R. Pharyngeal pH monitoring in patients with posterior laryngitis. Otolaryngol Head Neck Surg 1999; 120: 672-677. – reference: Day J, Briscoe M, Clark R, Ellis A, Gervais P. Onset of action and efficacy of terfenadine, astemizole, cetirizine, and loratadine for the relief of symptoms of allergic rhinitis. Ann Allergy Asthma Immunol 1997; 79: 163-172. – reference: Maw A. Development of tympanosclerosis in children with otitis media with effusion and ventilation tubes. J Laryngol Otol 1991; 105: 614-617. – reference: Gotzsche P. Statistics in medicine. Reference bias in reports of drug trials. BMJ 1987; 295: 654-656. – reference: Neely JG, Hartman JM, Wallace MS. Tutorials in Clinical Research: building the powerful 10-minute office visit. Part II: beginning a critical literature review. Laryngoscope 2001; 111: 70-76. – reference: Neely JG, Hartman JM, Wallace MS, Forsen JW, Jr., Tutorials in Clinical Research: Part III: selecting a research approach to best answer a clinical question. Laryngoscope 2001; 111: 821-830. – reference: Jacobsen S, Xia Z, Campion M, et al. Potential effect of authorization bias on medical record research. Mayo Clin Proc 1999; 74: 330-338. – reference: Neely JG, Hartman JM, Wallace MS. Building the powerful 10-minute office visit. Part I: introduction to the new section. Laryngoscope 2000; 110: 1595-1601. – reference: Webster's Third New International. Dictionary of the English Language Unabridged. Chicago: Encyclopaedia Britanica, Inc, 1976. – reference: Dickersin K. The existence of publication bias and risk factors for its occurrence. JAMA 1990; 263: 1385-1389. – reference: Feinstein AR. Clinical Epidemiology: The Architecture of Clinical Research. Philadelphia: W. B. Saunders Co, 1985. – reference: Chalmers TC, Frank CS, Reitman D. Minimizing the three stages of publication bias. JAMA 1990; 263: 1392-1395. – year: 1985 – volume: 111 start-page: 70 year: 2001 end-page: 76 article-title: Tutorials in Clinical Research: building the powerful 10‐minute office visit. Part II: beginning a critical literature review publication-title: Laryngoscope – year: 1986 – volume: 120 start-page: 672 year: 1999 end-page: 677 article-title: Pharyngeal pH monitoring in patients with posterior laryngitis publication-title: Otolaryngol Head Neck Surg – volume: 263 start-page: 1385 year: 1990 end-page: 1389 article-title: The existence of publication bias and risk factors for its occurrence publication-title: JAMA – volume: 105 start-page: 371 year: 1996 end-page: 378 article-title: Bell's palsy treatment with acyclovir and prednisone compared with prednisone along: a double‐blind, randomized, controlled trial publication-title: Ann Otol Rhinol Laryngol – volume: 295 start-page: 654 year: 1987 end-page: 656 article-title: Statistics in medicine. 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Snippet	Objective This is the fourth of a series of Tutorials in Clinical Research. 1–3 The objectives of this article are to heighten reader awareness of biases and... This is the fourth of a series of Tutorials in Clinical Research (1-3). The objectives of this article are to heighten reader awareness of biases and of...
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SubjectTerms	Bias Bias (Epidemiology) Biological and medical sciences Case-Control Studies clinical protocols Cohort Studies confounding factors Curriculum Education, Medical, Continuing Humans Medical sciences Miscellaneous Otolaryngology - education Public health. Hygiene Public health. Hygiene-occupational medicine Publication Bias Randomized Controlled Trials as Topic - statistics & numerical data research design research/methods
Title	Tutorials in Clinical Research: Part IV: Recognizing and Controlling Bias
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