EDITORIAL
Case Reports, Clinical Practice Guidelines, and Evidence David S. Riley, MD, Associate Editor
“Without clinical expertise, practice risks becoming tyrannized by evidence, for even excellent evidence may be inappropriate for an individual patient.” –David Sackett1 Case reports that adhere to the CARE guidelines can be sufficiently rigorous to inform clinical practice, clinical practice guidelines, and clinical trial design. These reporting guidelines define a framework for the systematic reporting of data from the point of care. We believe that high-quality case reports, written with adherence to these reporting guidelines, provides early evidence of not only adverse events, but also effectiveness and cost. Case reports have historically been important, but the quality has been uneven.2 Gagnier et al3 wrote, They have proved helpful in the identification of adverse and beneficial effects, the recognition of new diseases, unusual forms of common diseases, and the presentation of rare diseases. For example, our understanding of the relationship between thalidomide and congenital abnormalities and the use of propranolol for the treatment of infantile hemangiomas began with case reports.
Data analysis of systematically collected information from the point of care—some published as case reports—has created opportunities for close-to-real-time signals from clinical encounters. In 2011, Joel Gagnier, ND, MSc, PhD, of the University of Michigan; Gunver Kienle, Dr med, of the University of Witten Herdecke; and David Riley, MD, of the National College of Natural Medicine led the development of reporting guidelines for case reports—the CARE guidelines. These guidelines were presented at the triannual International Congress on Peer Review and Biomedical Publication sponsored by the Journal of the America Medical Association and the British Medical Journal in Chicago, Illinois, in 2013, and they were published in multiple medical journals.3 The CARE guidelines and checklist are currently available in multiple languages and are accepted as the standard for published case reports by many medical journals, and they are part of the Equator Network’s health research reporting guidelines library. The CARE guidelines, CARE checklist, and other documents are available on the CARE-Statement Web site.i Members of the CARE group steering group 78
Integrative Medicine • Vol. 14, No. 5 • October 2015
have participated in the incorporation of the CARE guidelines into clinical data collection research projects at academic medical centers and helped write CARE guidelines extensions for specific medical specialties. The publisher InnoVision Professional Media and the peer-reviewed, indexed medical journal—Integrative Medicine: A Clinicians Journal (IMCJ)—support the CARE guidelines and will begin to publish high-quality case reports that follow these reporting guidelines. Please visit the IMCJ Web site for author guidelines for case reports.ii We believe that evidence from case reports can be integrated with the data from controlled clinical trials (both efficacy and pragmatic trials), systematic reviews, and observational studies to form an evidence mosaic that provides a more complete and accurate picture of the effectiveness of therapeutic interventions and outcomes. High-quality case reports (1) support expanded therapeutic options for patients; (2) support enhanced critical thinking for clinicians, residents, and students; (3) facilitate the ongoing evaluation of clinical practice guidelines so that they are more useful; (4) generate hypotheses for clinical research; and (5) support innovation and postmarketing surveillance tools for the health care industry. The continued growth of published case reports today in the peer-reviewed medical literature suggests they contain valuable information. Patients often do not fit into neat boxes defined by the inclusion and exclusion criteria of clinical trials and clinicians are forced to adapt. Clinical practice is a complex interplay between experience and external evidence and must draw on data from a variety of sources. The editors of IMCJ believe that part of the value of case reports lies in their inherently individualized information—increasingly important in an era of genomic testing, chronic disease, and individualized medicine. References
1. Sackett D. Evidence based medicine: what it is and what it isn’t. BMJ. 1996;312(7023):71-72. 2. Richason TP, Paulson SM, Lowenstein SR, Heard KJ. Case reports describing treatments in the emergency medicine literature: missing and misleading information. BMC Emerg Med. June 2009;9:10. 3. Gagnier J, Kiene G, Altman DG, Moher D, Sox H, Riley DS, and the CARE group. The CARE guidelines: consensus-based clinical case report guideline development. Global Adv Health Med. 2013;2(5):38-43.
i. To view the documents, please visit http://www.care-statement.org/. ii. The IMCJ Web site is located at http://www.imjournal.com.
Riley—Editorial
Case Reports, Clinical Practice Guidelines, and Evidence David S. Riley, MD, Associate Editor
“Without clinical expertise, practice risks becoming tyrannized by evidence, for even excellent evidence may be inappropriate for an individual patient.” –David Sackett1 Case reports that adhere to the CARE guidelines can be sufficiently rigorous to inform clinical practice, clinical practice guidelines, and clinical trial design. These reporting guidelines define a framework for the systematic reporting of data from the point of care. We believe that high-quality case reports, written with adherence to these reporting guidelines, provides early evidence of not only adverse events, but also effectiveness and cost. Case reports have historically been important, but the quality has been uneven.2 Gagnier et al3 wrote, They have proved helpful in the identification of adverse and beneficial effects, the recognition of new diseases, unusual forms of common diseases, and the presentation of rare diseases. For example, our understanding of the relationship between thalidomide and congenital abnormalities and the use of propranolol for the treatment of infantile hemangiomas began with case reports.
Data analysis of systematically collected information from the point of care—some published as case reports—has created opportunities for close-to-real-time signals from clinical encounters. In 2011, Joel Gagnier, ND, MSc, PhD, of the University of Michigan; Gunver Kienle, Dr med, of the University of Witten Herdecke; and David Riley, MD, of the National College of Natural Medicine led the development of reporting guidelines for case reports—the CARE guidelines. These guidelines were presented at the triannual International Congress on Peer Review and Biomedical Publication sponsored by the Journal of the America Medical Association and the British Medical Journal in Chicago, Illinois, in 2013, and they were published in multiple medical journals.3 The CARE guidelines and checklist are currently available in multiple languages and are accepted as the standard for published case reports by many medical journals, and they are part of the Equator Network’s health research reporting guidelines library. The CARE guidelines, CARE checklist, and other documents are available on the CARE-Statement Web site.i Members of the CARE group steering group 78
Integrative Medicine • Vol. 14, No. 5 • October 2015
have participated in the incorporation of the CARE guidelines into clinical data collection research projects at academic medical centers and helped write CARE guidelines extensions for specific medical specialties. The publisher InnoVision Professional Media and the peer-reviewed, indexed medical journal—Integrative Medicine: A Clinicians Journal (IMCJ)—support the CARE guidelines and will begin to publish high-quality case reports that follow these reporting guidelines. Please visit the IMCJ Web site for author guidelines for case reports.ii We believe that evidence from case reports can be integrated with the data from controlled clinical trials (both efficacy and pragmatic trials), systematic reviews, and observational studies to form an evidence mosaic that provides a more complete and accurate picture of the effectiveness of therapeutic interventions and outcomes. High-quality case reports (1) support expanded therapeutic options for patients; (2) support enhanced critical thinking for clinicians, residents, and students; (3) facilitate the ongoing evaluation of clinical practice guidelines so that they are more useful; (4) generate hypotheses for clinical research; and (5) support innovation and postmarketing surveillance tools for the health care industry. The continued growth of published case reports today in the peer-reviewed medical literature suggests they contain valuable information. Patients often do not fit into neat boxes defined by the inclusion and exclusion criteria of clinical trials and clinicians are forced to adapt. Clinical practice is a complex interplay between experience and external evidence and must draw on data from a variety of sources. The editors of IMCJ believe that part of the value of case reports lies in their inherently individualized information—increasingly important in an era of genomic testing, chronic disease, and individualized medicine. References
1. Sackett D. Evidence based medicine: what it is and what it isn’t. BMJ. 1996;312(7023):71-72. 2. Richason TP, Paulson SM, Lowenstein SR, Heard KJ. Case reports describing treatments in the emergency medicine literature: missing and misleading information. BMC Emerg Med. June 2009;9:10. 3. Gagnier J, Kiene G, Altman DG, Moher D, Sox H, Riley DS, and the CARE group. The CARE guidelines: consensus-based clinical case report guideline development. Global Adv Health Med. 2013;2(5):38-43.
i. To view the documents, please visit http://www.care-statement.org/. ii. The IMCJ Web site is located at http://www.imjournal.com.
Riley—Editorial
