Overview of evidence-based medicine: challenges for evidence-based laboratory medicine.

Evidence-based medicine (EBM) has been driven by the need to cope with information overload, by cost-control, and by a public impatient for the best in diagnostics and treatment. Clinical guidelines, care maps, and outcome measures are quality improvement tools for the appropriateness, efficiency, and effectiveness of health services. Although they are imperfect, their value increases with the quality of the evidence they incorporate. Laboratory professionals must direct more effort to demonstrating the impact of laboratory tests on a greater variety of clinical outcomes. Laboratory and clinical practitioners must be familiar with many of the accessible electronic and paper tools for searching for evidence. Detailed statistical and epidemiologic knowledge is not essential, but critical appraisal skills and a competent understanding of the strengths and weaknesses of systematic review and metaanalysis are necessary. Overemphasis on complexity and failure to recognize time limitations are major barriers to translating EBM into everyday practice. Emphasizing and practicing the role of the laboratory professional as a skilled clinical consultant strongly grounded in evidence as well, in addition to better integration of laboratory and clinical information and improved laboratory reports will overcome most barriers. There is a poverty of good, primary studies of test evaluations. Institution of more consistent standards for the design and reporting of studies on diagnostic accuracy should improve the situation. If nothing else, systematic reviews have demonstrated the need for more good-quality primary research in laboratory medicine.

[1]  K. Lohr,et al.  Effectiveness and outcomes in health care : proceedings of an invitational conference by the Institute of Medicine, Division of Health Care Services , 1990 .

[2]  Gordon H. Guyatt,et al.  Users' Guides to the Medical Literature: III. How to Use an Article About a Diagnostic Test A. Are the Results of the Study Valid? , 1994 .

[3]  I. Olkin,et al.  Improving the quality of reporting of randomized controlled trials. The CONSORT statement. , 1996, JAMA.

[4]  David R. Jones,et al.  Systematic reviews of trials and other studies. , 1998, Health technology assessment.

[5]  D. Sackett Evidence-Based Medicine: How to Practice and Teach EBM , 2018 .

[6]  O. Norheim Healthcare rationing—are additional criteria needed for assessing evidence based clinical practice guidelines? , 1999, BMJ.

[7]  George Davey Smith,et al.  meta-analysis bias in location and selection of studies , 1998 .

[8]  J. Lott,et al.  Diagnosis and monitoring of hepatic injury. I. Performance characteristics of laboratory tests. , 2000, Clinical chemistry.

[9]  R. Simes Publication bias: the case for an international registry of clinical trials. , 1986, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[10]  G. B. Morgagni,et al.  The seats and causes of diseases investigated by anatomy , 1960 .

[11]  J. Heffner The overarching challenge. , 2000, Chest.

[12]  H. Lowe,et al.  Understanding and using the medical subject headings (MeSH) vocabulary to perform literature searches. , 1994, JAMA.

[13]  Douglas G Altman,et al.  Better reporting of randomised controlled trials: the CONSORT statement , 1996, BMJ.

[14]  Enrico Coiera,et al.  Recent Advances: Medical informatics , 1995 .

[15]  K. Dickersin The existence of publication bias and risk factors for its occurrence. , 1990, JAMA.

[16]  L. Hedges,et al.  The Handbook of Research Synthesis , 1995 .

[17]  D. Cook,et al.  A guide to interpreting discordant systematic reviews. , 1997, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[18]  B. Hurwitz,et al.  Legal and political considerations of clinical practice guidelines , 1999, BMJ.

[19]  D. Sackett,et al.  A controlled trial of teaching critical appraisal of the clinical literature to medical students. , 1987, JAMA.

[20]  Trisha Greenhalgh,et al.  How to read a paper: Papers that report diagnostic or screening tests , 1997, BMJ.

[21]  M. Tramèr,et al.  Impact of covert duplicate publication on meta-analysis: a case study , 1997, BMJ.

[22]  C P Price,et al.  Point of Care Testing , 1999, BMJ : British Medical Journal.

[23]  M. Phillips,et al.  Clinical paths for cardiac surgery patients: a multidisciplinary approach to quality improvement outcomes. , 1994, Journal of nursing care quality.

[24]  A. Hillman,et al.  Competing Practice Guidelines: Using Cost-Effectiveness Analysis To Make Optimal Decisions , 1998, Annals of Internal Medicine.

[25]  L. Shaw,et al.  Prospective investigations of concentration-clinical response for immunosuppressive drugs provide the scientific basis for therapeutic drug monitoring. , 1998, Clinical chemistry.

[26]  G. Omenn,et al.  A quantitative assessment of plasma homocysteine as a risk factor for vascular disease. Probable benefits of increasing folic acid intakes. , 1995, JAMA.

[27]  Ellwood Pm,et al.  Shattuck Lecture--outcomes management. A technology of patient experience. 1988. , 1997, Archives of pathology & laboratory medicine.

[28]  M. McQueen Will physicians and scientists have any role in managing laboratory resources in the year 2000? , 1996, European journal of clinical chemistry and clinical biochemistry : journal of the Forum of European Clinical Chemistry Societies.

[29]  J. Whitfield,et al.  Should We Use Carbohydrate-deficient Transferrin instead of γ-Glutamyltransferase for Detecting Problem Drinkers? A Systematic Review and Metaanalysis , 2000 .

[30]  S C Kazmierczak,et al.  Statistical Techniques for Evaluating the Diagnostic Utility of Laboratory Tests , 1999, Clinical chemistry and laboratory medicine.

[31]  R. W. Niessen,et al.  The Science of Systematic Reviewing Studies of Diagnostic Tests , 2000, Clinical chemistry and laboratory medicine.

[32]  D. Sackett,et al.  On some clinically useful measures of the accuracy of diagnostic tests , 1998, Evidence Based Medicine.

[33]  J Glanville,et al.  Finding information on clinical effectiveness , 1998, BMJ.

[34]  Anna Donald,et al.  Getting Research Findings into Practice , 1998 .

[35]  D. Sackett,et al.  Criteria for evaluating evidence that laboratory abnormalities are associated with the development of venous thromboembolism. , 2000, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[36]  L. Casalino The unintended consequences of measuring quality on the quality of medical care. , 1999, The New England journal of medicine.

[37]  A. Carr,et al.  Primary total hip replacement surgery: a systematic review of outcomes and modelling of cost-effectiveness associated with different prostheses. , 1998, Health technology assessment.

[38]  Jennifer P Brandenburg,et al.  Practice Guidelines and Malpractice Litigation: A Two-Way Street , 1995, Annals of Internal Medicine.

[39]  J. Grimshaw,et al.  Potential benefits, limitations, and harms of clinical guidelines , 1999, BMJ.

[40]  Trisha Greenhalgh,et al.  How to read a paper: The Medline database , 1997, BMJ.

[41]  I. Chalmers The Cochrane Collaboration: Preparing, Maintaining, and Disseminating Systematic Reviews of the Effects of Health Care , 1993, Annals of the New York Academy of Sciences.

[42]  J. Lott,et al.  Diagnosis and Monitoring of Hepatic Injury. II. Recommendations for Use of Laboratory Tests in Screening, Diagnosis, and Monitoring , 2000, Clinical chemistry.

[43]  Linus Pauling,et al.  How to Live Longer and Feel Better , 1986 .

[44]  A. Epstein,et al.  Performance reports on quality--prototypes, problems, and prospects. , 1995, The New England journal of medicine.

[45]  D. Bruns,et al.  Toward a checklist for reporting of studies of diagnostic accuracy of medical tests. , 2000, Clinical chemistry.

[46]  A. Taylor-Vaisey,et al.  Translating guidelines into practice. A systematic review of theoretic concepts, practical experience and research evidence in the adoption of clinical practice guidelines. , 1997, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[47]  R. J. Hayes,et al.  Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. , 1995, JAMA.

[48]  David R. Jones,et al.  Empirical assessment of effect of publication bias on meta-analyses , 2000, BMJ : British Medical Journal.

[49]  J. Ioannidis,et al.  Quantitative Synthesis in Systematic Reviews , 1997, Annals of Internal Medicine.

[50]  D. Cook,et al.  Systematic Reviews: Synthesis of Best Evidence for Clinical Decisions , 1997, Annals of Internal Medicine.

[51]  A. Detsky,et al.  Evidence-based medicine. A new approach to teaching the practice of medicine. , 1992, JAMA.

[52]  J C Boyd,et al.  Mathematical tools for demonstrating the clinical usefulness of biochemical markers. , 1997, Scandinavian journal of clinical and laboratory investigation. Supplementum.

[53]  A. Berger,et al.  The renaissance of C reactive protein , 2001, BMJ : British Medical Journal.

[54]  D. Sackett,et al.  Evidence based medicine: what it is and what it isn't , 1996, BMJ.

[55]  W. Kissick Medicine's Dilemmas: Infinite Needs versus Finite Resources , 1994 .

[56]  C. Naylor,et al.  Do we know what inappropriate laboratory utilization is? A systematic review of laboratory clinical audits. , 1998, JAMA.

[57]  M. McQueen,et al.  Evidence-based medicine: its application to laboratory medicine. , 2000, Therapeutic drug monitoring.

[58]  E. McCrum,et al.  Randomised controlled trial of the READER method of critical appraisal in general practice , 1998, BMJ.

[59]  W. Rosenberg,et al.  Evidence based medicine: an approach to clinical problem-solving , 1995, BMJ.

[60]  A D Oxman,et al.  No magic bullets: a systematic review of 102 trials of interventions to improve professional practice. , 1995, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[61]  Richard J. Coffey,et al.  An introduction to critical paths. , 1992 .

[62]  R. Brian Haynes,et al.  Where's the meat in clinical journals? , 1993, ACP Journal Club.

[63]  D. Rennie,et al.  The Cochrane Collaboration. Preparing, maintaining, and disseminating systematic reviews of the effects of health care. , 1995, JAMA.

[64]  Peter Langhorne,et al.  Integrating Heterogeneous Pieces of Evidence in Systematic Reviews , 1997, Annals of Internal Medicine.

[65]  M. Schaller,et al.  Successful implementation of guidelines for encouraging the use of beta blockers in patients after acute myocardial infarction. , 1999, The American journal of medicine.

[66]  A. Donabedian Criteria, norms and standards of quality: what do they mean? , 1981, American journal of public health.

[67]  Andrew D Oxman,et al.  Closing the gap between research and practice : an overview of systematic reviews of interventions to promote the implementation of research findings , 2011 .

[68]  B. Sibbald,et al.  Getting research into practice. , 1997, Journal of evaluation in clinical practice.

[69]  The clinical chemist , 1999, Clinical chemistry.

[70]  Mark Petticrew,et al.  Systematic reviews from astronomy to zoology: myths and misconceptions , 2001, BMJ : British Medical Journal.

[71]  Evidence-based medicine: Past, present and future , 2002 .

[72]  R. Simes,et al.  Publication bias: evidence of delayed publication in a cohort study of clinical research projects , 1997, BMJ.

[73]  Fiona Godlee,et al.  Getting evidence into practice , 1998 .

[74]  B. Haynes,et al.  Barriers and bridges to evidence based clinical practice , 1998, BMJ.

[75]  M. B. Crummer,et al.  Critical pathways--the pivotal tool. , 1993, The Journal of cardiovascular nursing.

[76]  P. Bossuyt,et al.  Empirical evidence of design-related bias in studies of diagnostic tests. , 1999, JAMA.

[77]  G. Guyatt,et al.  Users' guides to the medical literature. , 1993, JAMA.

[78]  Trisha Greenhalgh,et al.  How to Read a Paper , 1999 .

[79]  P Glasziou,et al.  Meta-analytic methods for diagnostic test accuracy. , 1995, Journal of clinical epidemiology.

[80]  A. Detsky,et al.  A clinician's guide to cost-effectiveness analysis. , 1990, Annals of internal medicine.

[81]  Trisha Greenhalgh,et al.  How to read a paper: Papers that summarise other papers (systematic reviews and meta-analyses) , 1997 .

[82]  G. Glass Primary, Secondary, and Meta-Analysis of Research1 , 1976 .

[83]  P A Hofmann,et al.  Critical path method: an important tool for coordinating clinical care. , 1993, The Joint Commission journal on quality improvement.

[84]  P. Easterbrook,et al.  Publication bias in clinical research , 1991, The Lancet.

[85]  K. Lohr,et al.  Applying Effectiveness and Outcomes Research to Clinical Practice , 1990 .

[86]  M. Panteghini,et al.  The Sensitivity of Cardiac Markers: an Evidence-based Approach , 1999, Clinical chemistry and laboratory medicine.

[87]  P. Shekelle,et al.  Clinical guidelines: developing guidelines. , 1999, BMJ.

[88]  Nick Freemantle,et al.  Computer support for determining drug dose: systematic review and meta-analysis , 1999, BMJ.

[89]  Frederick Mosteller,et al.  Guidelines for Meta-analyses Evaluating Diagnostic Tests , 1994, Annals of Internal Medicine.

[90]  M. Bissell Laboratory-Related Measures of Patient Outcomes: An Introduction , 2000 .

[91]  A R Feinstein,et al.  Use of methodological standards in diagnostic test research. Getting better but still not good. , 1995, JAMA.

[92]  A. Ellrodt,et al.  Can practice guidelines safely reduce hospital length of stay? Results from a multicenter interventional study. , 1998, The American journal of medicine.

[93]  J. Sidorov,et al.  How are internal medicine residency journal clubs organized, and what makes them successful? , 1995, Archives of internal medicine.

[94]  P. Easterbrook Directory of registries of clinical trials. , 1992, Statistics in medicine.