Clinical Research Methods: An Annotated Bibliography
Authors: RESEARCH DEVELOPMENT COMMITTEE
Journal: Annals of Internal Medicine (1983)

The Literature of Medicine1 September 1983Clinical Research Methods: An Annotated BibliographyRESEARCH DEVELOPMENT COMMITTEERESEARCH DEVELOPMENT COMMITTEESearch for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-99-3-419 SectionsAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail ExcerptThis annotated bibliography includes 100 references to journal articles and books primarily concerned with the design, conduct, analysis, reporting, and interpretation of clinical research. The bibliography was compiled by the Research Development Committee of The Society for Research and Education in Primary Care Internal Medicine. We include articles about the acquisition of valid information on which clinical decisions can be made as well as articles on the decision-making process itself. The bibliography is intended for clinicians who do clinical research, read and critique published articles, teach research skills to others, and use the results of clinical research to make decisions....General Clinical Trials Case-Control Studies Prognosis Biostatistics Measurement Cause-and-Effect Diagnostic Tests Decision Making1. BERWICKFINEBERGWEINSTEIN DHM. When doctors meet numbers. Am J Med. 1981;71:991-8. Using hypothetical clinical questions, the authors assessed mastery of vocabulary and rules of inference apparently relevant to the use of quantitative information. Performance was poor, and comparable for medical students, house officers, and academic physicians. CrossrefMedlineGoogle Scholar2. . HOW to read clinical journals: I. Why to read them and how to start reading them critically. Can Med Assoc J. 1981;124:555-8. Proposes basic guidelines for critically reading an article in a clinical journal. MedlineGoogle Scholar3. FEINSTEIN A. Clinical Biostatistics. St. Louis: C. V. Mosby Co.; 1977. (Chapters also appeared as essays in Clin Pharm Ther, 1970-5). A collection of essays on the scientific concepts of clinical research, including the "architecture" of cohort research, measurement, statistical strategies, and the analysis of multiple variables. An advanced presentation, but clinicians without highly developed statistical skills can read and understand this book. CrossrefGoogle Scholar4. FEINSTEINHORWITZ AR. Double standards, scientific methods, and epidemiologic research. N Engl J Med. 1982;307:1611-7. Explains how observational research—cohort and case-control studies—can be made more rigorous by using the principles of an experiment as guidelines to the design of observational studies. CrossrefMedlineGoogle Scholar5. FLETCHERFLETCHER RS. Clinical research in general medical journals: a 30-year perspective. N Engl J Med. 1979;301:180-3. Describes the research design used in original research published in three general medical journals—The Journal of the American Medical Association, The Lancet, and The New England Journal of Medicine—for 1946, 1956, 1966, and 1976. CrossrefMedlineGoogle Scholar6. FLETCHERFLETCHERWAGNER RSE. Clinical Epidemiology—The Essentials. Baltimore: Williams and Wilkins; 1982. A basic textbook about the interpretation of clinical evidence, including chapters on diagnostic tests and strategies, measures of disease frequency, risk, prognosis, and treatment. Google Scholar7. GEHLBACH S. Interpreting the Medical Literature. A Clinician's Guide. Lexington, Massachusetts: D. C. Heath, 1982. Written to "provide clinicians with an approach to reading and understanding research articles that appear in medical journals." Google Scholar8. INUI T. Critical reading seminars for medical residents: report of a teaching technique. Med Care. 1981;19:122-4. Discussion of an apparently popular approach to teaching medical residents research methods and critical reading skills. Includes brief description of organization, teaching strategy, seminar content, and examples of articles. CrossrefMedlineGoogle Scholar9. KLEINBAUMKUPPERMORGANSTERN DLH. Epidemiologic Research. Principles and Quantitative Methods. Belmont, California: Lifetime Learning Publications; 1982. Although ostensibly about "epidemiologic" research, applies to much of clinical research as well. Covers measures of disease frequency and association, research designs, sources and control of bias, and statistical analysis. Requires experience with basic biostatistics. Google Scholar10. MAINLAND D. Medical statistics—thinking versus arithmetic. J Chronic Dis. 1982;35:413-7. The author places in perspective the contributions of technical statistics and understanding the role they play in clinical investigation. CrossrefMedlineGoogle Scholar11. MARKS R. Developing a Research Project. Belmont, California: Lifetime Learning Publications; 1982. Written for clinicians without experience in research. Provides basic information needed to design a research project. Google Scholar12. MURPHY E. The Logic of Medicine. Baltimore: Johns Hopkins University Press; 1976. A collection of thoughtful and erudite essays on the rules of evidence in medicine, written to "cultivate an alert common sense." Google Scholar13. RIEGELMAN R. Studying a Study and Testing a Test. How to Read the Medical Literature. Boston: Little, Brown and Company; 1981. Uses hypothetical studies to show common errors in retrospective, prospective, and experimental studies. Provides framework for critically evaluating research studies, diagnostic tests and rates of disease. Includes a nonmathematical flow sheet approach to biostatistics. Google Scholar14. ROBERTSSPITZERDELMORESACKETT RWTD. An empirical demonstration of Berkson's bias. J Chronic Dis. 1978;31:119-28. Reviews errors that can occur if associations among diseases identified in hospitals are assumed to prevail in the general, non-hospitalized population. Uses data from a population and the hospitals serving it to show this problem. CrossrefMedlineGoogle Scholar15. ROSEBARKER GD. Epidemiology for the Uninitiated. London: British Medical Association; 1979. (Also published as a series beginning in Br Med J. 1978;2:803-4). A series of 15 brief articles on the basics of epidemiologic methods. Google Scholar16. SACKETT D. Bias in analytic research. J Chronic Dis. 1979;32:51-63. A discussion and catalog of biases that can distort the design, execution, analysis, and interpretation of analytic research. The strengths and weaknesses of cohort and case-control studies are compared. CrossrefMedlineGoogle Scholar17. WULFF H. Rational Diagnosis and Treatment. 2nd ed. Oxford: Blackwell Scientific Publications; 1976. A book for clinicians about rational decision-making and the application of the scientific method to clinical medicine. Google Scholar18. BUCKDONNER CA. The design of controlled experiments in the evaluation of non-therapeutic interventions. J Chronic Dis. 1982;35:531-8. Discusses group versus individual randomization, the number of control groups, Hawthorne effects, study dropouts, and substitutes for the "double-blind" conditions usually advocated for clinical trials. CrossrefMedlineGoogle Scholar19. CHALMERSSMITHAMBROZREITMANSCHROEDER THADB. In defense of the VA randomized control trial of coronary artery surgery. Clin Res. 1978;26:230-5. For an influential and controversial trial, analyzes the methodologic criteria and comparability of patients, intervention, and outcome to other trials. Also presents data on how published opinion about the study are related to the professional activities of the authors of those opinions. Google Scholar20. CHALMERS T. A potpourri of RCT topics. Controlled Clin Trials. 1982;3:285-98. Discusses five concepts: randomization of the first patient, factorially structured treatments, control groups as a source of unnatural history, bias in random and non-random treatment assignments, and time lags between innovation, clinical trials, and practice. CrossrefMedlineGoogle Scholar21. CHALMERSSMITHBLACKBURN THB. A method for assessing the quality of a randomized control trial. Controlled Clin Trials. 1981;2:31-49. Sets out standards for a good randomized control trial. CrossrefMedlineGoogle Scholar22. . Influence of adherence to treatment and response of cholesterol on mortality in the coronary drug project. N Engl J Med. 1980;303:1038-41. Patients compliant with placebo had lower mortality rates than those not compliant with placebo. The authors caution against evaluating treatment efficacy in subgroups determined by patient responses to the treatment protocol after randomization. CrossrefMedlineGoogle Scholar23. . HOW to read clinical journals: V. To distinguish useful from useless or even harmful therapy. Can Med Assoc J. 1981;124:1156-62. A guide to judging the quality of scientific evidence for or against therapeutic efficacy. MedlineGoogle Scholar24. DERSIMONIANCHARETTEMCPEEKMOSTELLER RLBF. Reporting on methods in clinical trials. N Engl J Med. 1982;306:1332-7. The authors identify 11 important aspects of the design and analysis of clinical trials, and describe how often these were reported in 67 articles from three general medical journals, 1979-80. CrossrefMedlineGoogle Scholar25. DIAMONDFORRESTER GJ. Clinical trials and statistical verdicts: probable grounds for appeal. Ann Intern Med. 1983;98:385-94. Applies Bayesian analysis to the interpretation of clinical trials and shows the limitations of exclusive reliance on p values. LinkGoogle Scholar26. ELASHOFF J. Combining results of clinical trials [Editorial]. Gastroenterology. 1978;75:1170-2. Considers the potentials and pitfalls of combining results of several clinical trials of a similar treatment, each of which is in itself insufficient to answer the question of efficacy. CrossrefMedlineGoogle Scholar27. ELWOOD J. Interpreting clinical trial results: seven steps to understanding. Can Med Assoc J. 1980;123:343-5. Presents seven questions that serve as a general framework for the methodologic assessment of a clinical trial. MedlineGoogle Scholar28. FRIEDMANFURBERGDEMETS LCD. Fundamentals of Clinical Trials. Littleton, Massachusetts: John Wright, PSG Inc.; 1981. Brings together basic information about the design, conduct, and analysis of clinical trials. Suitable for investigators with and without previous experience with clinical trials. Google Scholar29. GEHANFREIREICH EE. Non-randomized controls in cancer clinical trials. N Engl J Med. 1974;290:198-203. Summarizes alternatives to randomized controls in clinical trials, and presents the case against randomization. CrossrefMedlineGoogle Scholar30. HILLSARMITAGE MP. The two-period cross-over clinical trial. Br J Clin Pharmacol. 1979;8:7-20. The rationale, design and analysis of cross-over trials. CrossrefMedlineGoogle Scholar31. MAYDEMETSFRIEDMANFURBERGPASSAMANI GDLCE. The randomized clinical trial: bias in analysis. Circulation. 1981;64:669-73. Improper analysis of data from a randomized trial can lead to biased inferences. Withdrawing patients from consideration in the analysis because of violation of study entry criteria, lack of compliance to the protocol, or incomplete data may be a source of systematic error. CrossrefMedlineGoogle Scholar32. MEINERT C. Fundings for clinical trials. Controlled Clin Trials. 1982;3:165-71. Clinical trials are the soundest design for evaluating the effects of interventions, but often are not feasible because of cost. The median cost for a representative sample of recent National Institutes of Health-funded trials was $453 to $1657 per patient per year. CrossrefMedlineGoogle Scholar33. MOSTELLERGILBERTMCPEEK FJB. Reporting standards and research strategies for controlled trials: agenda for the editor. Controlled Clin. Trials. 1980;1:37-58. For a sample of controlled clinical trials in cancer research, describes the frequency of reporting important statistical and procedural matters: randomization, statistical method, blindness, power, sample size, survival, and informed consent. Recommends standards for reporting. CrossrefGoogle Scholar34. PETOPIKEARMITAGE RMP. Design and analysis of randomized clinical trials requiring prolonged observation of each patient: I. Introduction and design. Br J Cancer. 1976;34:585-612. CrossrefMedlineGoogle Scholar35. PETOPIKEARMITAGE RMP. Design and analysis of randomized clinical trials requiring prolonged observation of each patient: II. Analysis and examples. Br J Cancer. 1977;35:1-39. An authoritative summary, intended to enable physicians without statistical training to design and analyze clinical trials. Emphasizes dealing with "censored" data and survival differences. CrossrefMedlineGoogle Scholar36. SACKETTGENT DM. Controversy in counting and attributing events in clinical trials. N Engl J Med. 1979;301:1410-2. Whether outcome events in clinical trials should be counted against the original (randomized) treatment or a later one depends on whether the authors intend to assess the effectiveness of a clinical treatment strategy in real-world circumstances or the biologic efficacy of a treatment under ideal conditions. CrossrefMedlineGoogle Scholar37. SACKSCHALMERSSMITH HTH. Randomized versus historical controls for clinical trials. Am J Med. 1982;72:233-40. Compares the results of randomized control trials with trials of the same therapies using historical controls. The findings suggest that patient selection biases the outcomes of the latter in favor of new therapies. CrossrefMedlineGoogle Scholar38. STAMPFERGOLDHABERYUSUFPETOHENNEKENS MSSRC. Effect of intravenous streptokinase on acute myocardial infarction: pooled results from randomized trials. N Engl J Med. 1982;307:1180-2. The results of eight randomized clinical trials with reasonably similar treatment protocols were pooled. Each trial's contribution to a weighted average was in proportion to the precision of its results. CrossrefMedlineGoogle Scholar39. ZELEN M. The randomization and stratification of patients to clinical trials. J Chronic Dis. 1974;27:365-75. Discusses alternatives for implementing randomization assignments in clinical trials. CrossrefMedlineGoogle Scholar40. ZELEN M. A new design for randomized clinical trials. N Engl J Med. 1979;300:1242-5. Proposes that randomization be done before informed consent is obtained, and all patients receiving standard treatment be compared to all who were assigned to the experimental treatment (whether or not they received it). CrossrefMedlineGoogle Scholar41. BRITTAINSCHLESSELMANSTADEL EJB. Cost of case-control studies. Am J Epidemiol. 1981;114:234-43. The typical cost per subject, in the mid-1970s, was $100 to $200; 75% of this cost was for data collection, 10% to 15% for planning and analysis. CrossrefMedlineGoogle Scholar42. COLE P. The evolving case-control study. J Chronic Dis. 1979;32:15-27. Points out limitations in our understanding of case-control research. Gives recommendations for improving the method. CrossrefMedlineGoogle Scholar43. CORNFIELDHAENSZEL JW. Some aspects of retrospective studies. J Chronic Dis. 1960;11:523-34. A classic paper on case-control studies: the relation to cohort studies, derivation of relative risk, sources of bias, and elimination of the effects of variables other than those of direct interest. CrossrefMedlineGoogle Scholar44. FEINSTEINHORWITZSPITZERBATTISTA ARWR. Coffee and pancreatic cancer: the problems of etiologic science and epidemiologic case-control research. JAMA. 1981;246:957-61. While critiquing a specific case-control study, discusses several methodologic problems and solutions, including: causal hypotheses generated by the data (not the investigators), "protopathic bias, " unbiased ("blind") collection of data on exposure, and the problem of multiple contrasts. CrossrefMedlineGoogle Scholar45. HAYDENKRAMERHORWITZ GMR. The case-control study: a practical review for the clinician. JAMA. 1982;247:326-31. Describes the advantages of case-control studies, and the methodologic hazards related to "selection of appropriate study groups; definition and detection of the outcome event; definition and ascertainment of the exposure; assurance that the compared groups were equally susceptible to the outcome event at baseline; and careful statistical analysis." CrossrefMedlineGoogle Scholar46. HORWITZFEINSTEIN RA. Methodologic standards and contradictory results in case-control research. Am J Med. 1979;66:556-64. Proposes methodologic standards that would enhance scientific quality of case-control research. In a sample of 85 case-control studies with conflicting or apparently invalid results, these standards were commonly violated. CrossrefMedlineGoogle Scholar47. IBRAHIM M, editor. The Case-Control Study. Consensus and Controversy. New York: Pergamon Press, 1979. (Also published as special issue of J Chronic Dis. 1979;32:1-144). The proceedings of a conference on case-control studies held in 1978. Contains presentations and in-depth discussions by many of the field's leading experts. Google Scholar48. MANTELHAENSZEL NW. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst. 1959;22:719-48. A classic paper on the role and limitations of retrospective investigations of factors possibly associated with the occurrence of disease (currently referred to as "case-control"). MedlineGoogle Scholar49. SCHLESSELMAN J. Case-Control Studies. New York: Oxford University Press; 1982. A comprehensive discussion of case-control studies—their role, design, conduct and analysis. Google Scholar50. . HOW to read clinical journals: III. To learn the clinical course and prognosis of disease. Can Med Assoc J. 1981;124:869-72. Suggests questions to guide reading an article about prognosis: was an "inception cohort" assembled, referral pattern described, complete follow-up achieved, objective outcome criteria developed and used, outcome assessment "blind" and adjustment for extraneous prognostic factors carried out? MedlineGoogle Scholar51. ELLENBERGNELSON JK. Sample selection and the natural history of disease: studies of febrile seizures. JAMA. 1980;243:243:1337-40. The incidence of unfavorable sequelae of childhood febrile seizures is higher in reports from hospital clinics and referral units than from population-based studies. Illustrates how patients cared for in clinics may not be representative of persons with the "same condition" in the general population. CrossrefMedlineGoogle Scholar52. MOTULSKY A. Biased ascertainment and the natural history of diseases. N Engl J Med. 1978;298:196-7. Points out how clinicians' experience and published reports may overestimate the severity of a disease by over-representing the experience of severely affected individuals. CrossrefGoogle Scholar53. ABT K. Problems of repeated significance testing. Controlled Clin Trials. 1981;1:377-81. Discusses inflation of the probability of a type I error (finding a significant difference by chance, when none actually exists) that accompanies repeated significance testing, at several times or for more than one variable. Considers alternative methods of dealing with this problem. CrossrefMedlineGoogle Scholar54. ANDERSONAUGUIERHAUCKOAKESVANDAELEWEISBERG SAWDWH. Statistical methods for comparative studies: techniques for bias reduction. In: Wiley Series in Probability and Mathematical Statistics: Applied Probability and Statistics. Somerset, New Jersey: John Wiley; 1980. A basic test on the analysis of data from clinical studies, emphasizing methods for reducing systematic differences between groups when making comparisons. Google Scholar55. BERWICK D. Experimental power: the other side of the coin. Pediatrics. 1980;65:1043-5. A clear, succinct description of statistical power and the type II error (failing to find a real difference between groups). MedlineGoogle Scholar56. FLEISS J. Statistical Methods for Rates and Proportions. 2nd ed. New York: John Wiley and Sons; 1981. A basic textbook on the statistical planning and analysis of studies in which variables are expressed as counts. Includes tables relating statistical significance, power, and the rate of occurrence in two groups. Google Scholar57. FREIMANCHALMERSSMITHKUEBLER JTHR. The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial: survey of 71 "negative" trials. N Engl J Med. 1978;299:690-4. Examines 71 clinical trials, published from 1960 to 1977, that concluded that treated patients fared no better than controls. Most of the trials did not include enough subjects to have a high probability (greater than 0.90) of detecting even large treatment effects (25% to 50%). CrossrefMedlineGoogle Scholar58. KLEINBAUMKUPPER DL. Applied Regression Analysis and Other Multivariable Methods. North Scituate, Massachusetts: Duxbury Press; 1978. A second-level statistics text for scientists engaged in applied research involving the simultaneous analysis of multiple variables. Google Scholar59. LACHIN J. Introduction to sample size determination and power analysis for clinical trials. Controlled Clin Trials. 1981;2:93-133. Describes various methods for determining prudent sample size before conducting clinical trials and performing power analysis after data are collected. CrossrefMedlineGoogle Scholar60. MARKS R. Analyzing Research Data. Belmont, California: Lifetime Learning Publications; 1982. A survery of statistical techniques, illustrated by clinical examples. Includes guidelines for critical analysis of journal articles using these techniques. Requires previous knowledge of basic statistics. Google Scholar61. ROTHMAN K. A show of confidence. N Engl J Med. 1978;299:1362-3. An appeal for the use of confidence intervals rather than "statistical significance" (p values) when reporting the results of statistical analyses. CrossrefMedlineGoogle Scholar62. ROTHMANBOICE KJ. Epidemiologic Analysis with a Programmable Calculator. Washington D.C.: U. S. Department of Health, Education and Welfare, 1979; NIH publication no. 79-1649. This handbook provides explanation and documentation for more than 20 programs, written for the HP 67, 7, or 41 series calculators, that facilitate epidemiologic analysis. Google Scholar63. TUKEY J. Some thoughts on clinical trials, especially problems of multiplicity. Science. 1977;198:679-84. Discusses the respective roles of "clinical inquiries" (unfocused, hypothesis-generating studies of medical interventions) versus focused clinical trials, which can test therapeutic hypotheses. Also describes "multiplicity", the consequences of examining many variables (such as patient subgroups and outcomes) within a study. CrossrefMedlineGoogle Scholar64. BERDIEANDERSON DJ. Questionaires: Design and Use. Metuchen, New Jersey: Scarecrow Press, Inc.; 1974. A clear, concise, practical guide to writing, testing, and revising questionnaires. Google Scholar65. DAVIDOFF F. Clinical medicine as a hard science. Clin Invest Med. 1981;4:57-81. Application of quantitative measurement techniques to screening, history and physical examination, reliability of clinical observations, and accuracy of prediction. Assesses current applications and recommends areas for further research. MedlineGoogle Scholar66. . Clinical disagreement: I. How often it occurs and why. Can Med Assoc J. 1980;123:499-504. Describes ten reasons why clinical disagreements occur. MedlineGoogle Scholar67. . Clinical disagreement: II. How to avoid it and how to learn from one's mistakes. Can Med Assoc J. 1980;123:613-7. Describes six strategies to prevent clinical disagreement and improve diagnostic accuracy. MedlineGoogle Scholar68. FEINSTEINKRAMER AM. Clinical biostatistics: LII. A primer on quantitative indexes of association. Clin Pharmacol Ther. 1980;28:130-45. Describes the construction and interpretation of basic indexes of association, including correlation and regression coefficients and their analogs for nondimensional data. CrossrefMedlineGoogle Scholar69. KANEKANE RR. Assessing the Elderly: A Practical Guide to Measurement. Lexington, Massachusetts: D. C. Heath; 1981. Reviews the state of the art in measuring physical, mental, and social functioning, together with multidimensional measures appropriate to the elderly. Raises appropriate cautions about how to use these available scales. Google Scholar70. KORAN L. The reliabilty of clinical methods, data and judgements. N Engl J Med. 1975;293:642-6, 695-701. Reviews the literature on the reproducibility of clinical observations, including physical signs, laboratory tests, diagnoses, selection of treatments, and evaluating the quality of care. CrossrefMedlineGoogle Scholar71. KRAMERFEINSTEIN MA. Clinical biostatistics LIV. The biostatistics of concordance. Clin Pharmacol Ther. 1981;29:111-23. Describes various indexes used to express the degree of agreement (concordance) between two variables, including percentage agreement, the kappa statistic, and measures of consistency for dimensional data. CrossrefMedlineGoogle Scholar72. SPODICK D. On experts and expertise: the effect of variability in observer performance. Am J Cardiol. 1975;36:592-6. Presents data showing the extent of disagreement among expert cardiologists when interpretating data and perceiving physical signs. CrossrefMedlineGoogle Scholar73. BRADFORD-HILL A. The environment and disease: association or causation. Proc R Soc Med. 1965;58:295-300. Proposes criteria for deciding if an observed association is a cause-and-effect relationship. These include strength, consistency, specificity, temporality, biologic gradient, plausibility, coherence, experiment, and analogy. MedlineGoogle Scholar74. PLATT J. Strong inference. Science. 1964;146:347-53. Reviews the bases of modern scientific research, and how certain methods of scientific thinking may produce more rapid progress than others. CrossrefMedlineGoogle Scholar75. . HOW to read clinical journals: IV. To determine etiology or causation. Can Med Assoc J. 1981;124:985-90. Describes nine "diagnostic tests for causation." MedlineGoogle Scholar76. . Guidelines for documentation of epidemiologic studies. Am J Epidemiol. 1981;114:609-13. These guidelines serve for any clinical studies of cause-and-effect, not just ones that are "epidemiologic". CrossrefMedlineGoogle Scholar77. EVANS A. Causation and disease: a chronological journey. Am J Epidemiol. 1978;108:249-58. Reviews the evolution of concepts of causation and disease: from the Koch postulates, to the broadening of these concepts to describe the causation of viral diseases, and chronic disease in general. CrossrefMedlineGoogle Scholar78. MIETTINENCOOK OE. Confounding: essence and detection. Am J Epidemiol. 1981;114:593-603. Careful consideration of confounding both in follow-up and prevalence studies on the one hand and case control studies on the other. CrossrefMedlineGoogle Scholar79. ROTHMAN K. Causes. Am J Epidemiol. 1976;104:587-92. A framework for conceptualizing how several factors act separately and together to cause disease. CrossrefMedlineGoogle Scholar80. WEISS N. Inferring causal relationships: elaboration of the criterion of "dose-response. " Am J Epidemiol. 1981;113:487-90. The "dose" of a causal agent can be characterized in several ways: intensity, duration, and interval after onset of exposure. CrossrefMedlineGoogle Scholar81. . HOW to read clinical journals: II. To learn about a diagnostic test. Can Med Assoc J. 1981;124:703-51. A guide to judging the quality of scientific evidence for or against use of a diagnostic test. MedlineGoogle Scholar82. EDDY D. Screening for Cancer: Theory, Analysis, and Design. Englewood Cliffs, New Jersey: Prentice-Hall Inc. ; 1980. A detailed presentation of a general theory of screening and its applications. Includes detailed discussion of the effect of natural history and test characteristics, as well as cost effectiveness. Google Scholar83. GALENGAMBINO RS. Beyond Normality: the Predictive Value and Efficacy of Medical Diagnoses. New York: John Wiley and Sons; 1975. A monograph on the accuracy of diagnostic tests, and how test performance is affected by the sensitivity and specificity of the test, prevalence of disease, and the sequence in which several tests are applied. Google Scholar84. GRINERMAYEWSKIMUSHLINGREENLAND PRAP. Selection and interpretation of diagnostic tests and procedures: principles and applications. Ann Intern Med. 1981;94(4 Pt 2):557-600. A monograph describing the principles of test selection, use, and interpretation. Applies these principles to several clinical conditions. MedlineGoogle Scholar85. PHILBRICKHORWITZFEINSTEINLANGOUCHANDLER JRARJ. The limited spectrum of patients studied in exercise test research: analyzing the tip of the iceberg. JAMA. 1982;248:2467-70. Only 3% of 205 consecutive exercise tests from 2 laboratories would have been included in a formal study of diagnostic efficacy if they were subject to typical exclusion criteria for ineligibility: equivocal results and no results of angiographic examination. CrossrefMedlineGoogle Scholar86. RANSOHOFFFEINSTEIN DA. Problems of spectrum and bias in evaluating the efficacy of diagnostic tests. N Engl J Med. 1978;299:926-30. Describes and illustrates two major biases to which studies of the accuracy of diagnostic tests are susceptible. CrossrefMedlineGoogle Scholar87. BECKPAUKERGOTTLIEBKLEINKASSIRER JSJKJ. A convenient approximation of life expectancy (the "DEALE"): II. Use in medical decision-making. Am J Med. 1982;73:889-97. New approximation for estimating quality adjusted survival in complex patients with several diseases. Allows bedside combination of diverse survival reports. CrossrefMedlineGoogle Scholar88. MCNEILKEELERADELSTEIN BES. Primer on certain elements of medical decision-making. N Engl J Med. 1975;293:211-5. Describes the theory behind interpreting diagnostic tests with continuous scale values, where the cut-off point between normal and abnormal can be selected and sensitivity is traded off against specificity to match the physicians' goals. CrossrefMedlineGoogle Scholar89. MCNEILWEICHSELBAUMPAUKER BRS. Fallacy of the five-year survival in lung cancer. N Engl J Med. 1978;299:1397-1401. Shows how the relative importance that persons place on the quality and quantity of life can be used in clinical decision-making. CrossrefMedlineGoogle Scholar90. MCNEILWEICHSELBAUMPAUKER BRS. Speech and survival: tradeoffs between quality and quantity of life in laryngeal cancer. N Engl J Med. 1981;305:982-7. Covers impact of patient preferences on decison-making. Introduces techniques of utility assessment. CrossrefMedlineGoogle Scholar91. METZ C. Basic principles of ROC analysis. Semin Nucl Med. 1978;8:283-98. An introduction to receiver operating characteristic (ROC) curves, empirical descriptions of the effects of choosing various diagnostic thresholds when interpreting a diagnostic test. CrossrefMedlineGoogle Scholar92. PATTON D. Introduction to clinical decision making. Semin Nucl Med. 1978;8:273-82. Includes a glossary of terms. CrossrefMedlineGoogle Scholar93. PAUKERKASSIRER SJ. Clinical application of decision analysis: a detailed illustration. Semin Nucl Med. 1978;8:324-35. Describes and illustrates how decision trees can be used for analyzing complex diagnostic and therapeutic questions. CrossrefMedlineGoogle Scholar94. PAUKERKASSIRER SJ. The threshold approach to clinical decision making. N Engl J Med. 1980;302:1109-17. Introduces concepts of sensitivity analysis and break-even points. Emphasizes the central role of uncertainty and the probability of disease. Allows physician to apply data at bedside. CrossrefMedlineGoogle Scholar95. SCHWARTZ W. Decision analysis: a look at the chief complaints. N Engl J Med. 1979;300:556-9. An editorial that deals with some of the reservations about applications of decision analysis to clinical decision-making. The author recognizes the limitations but remains a strong advocate. CrossrefMedlineGoogle Scholar96. SWETSPICKETT JR. Evaluation of Diagnostic Systems. Methods for Signal Detection Theory. New York: Academic Press; 1982. Provides an in-depth treatment of modern detection theory and its application to the evaluation of diagnostic tests. Serves as an advanced reference for the application of receiver operating characteristic curve analyses. Google Scholar97. WARNERLUCE KB. Cost-Benefit and Cost-Effectiveness Analysis in Health Care. Principles, Practice, and Potential. Ann Arbor: Health Administration Press; 1982. A thorough, balanced review of cost-benefit and cost-effectiveness analysis. Serves as both an introduction and reference work. Google Scholar98. WEINSTEIN M. Economic assessments of medical practices and technologies. Med Decision Making. 1981;1:309-30. A tutorial on cost effectiveness methods. The author argues for measures of effectiveness that allow comparison among interventions, for sensitivity analyses, and for inclusion of difficult-to-measure but important attributes of outcome. CrossrefMedlineGoogle Scholar99. WEINSTEINSTASON MW. Foundations of cost-effectiveness analysis for health and medical practices. N Engl J Med. 1977;296:716-21. An introduction that stresses the difference between cost-effectiveness and cost-benefit analysis. CrossrefMedlineGoogle Scholar100. WEINSTEINFINEBERG MH. Clinical Decision Analysis. Philadelphia: W. B. Saunders Co.; 1980. This text is a synthesis of statistical decision theory, epidemiology, psychology, and clinical medicine. It provides both introductory and advanced discussions of the use of diagnostic information to revise probabilities, the value of clinical information, utility theory, and cost-effectiveness analysis. Google Scholar This content is PDF only. To continue reading please click on the PDF icon. Author, Article, and Disclosure InformationAffiliations: *Robert H. Fletcher, M.D., Chairman; Ralph I. Horwitz, M.D.; Thomas S. Inui, M.D.; Robert Kane, M.D.; Eric B. Larson, M.D.; Albert G. Mulley, M.D.; Stephen G. Pauker, M.D.; Richard K. Riegelman, M.D.; Jeoffrey K. Stross, M.D.; Ramon Velez, M.D.; and Sankey V. Williams, M.D. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byClinical Science and Clinical Expertise: Changing Boundaries between Art and Science in MedicineTeaching research in the emergency medicine residency curriculumA game of numbers: Re-appraisal of antihypertensive drug therapyLearning Diagnostic RestraintClinical Epidemiology: A New Discipline for an Old ArtROBERT H. FLETCHER, M.D., SUZANNE W. FLETCHER, M.D. 1 September 1983Volume 99, Issue 3Page: 419-424 ePublished: 1 December 2008 Issue Published: 1 September 1983 Copyright & Permissions© 1983 American College of PhysiciansPDF downloadLoading ...