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Semin Neurol 2006; 26(1): 131-139
DOI: 10.1055/s-2006-933317
Copyright © 2006 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA.

Practice-Based Clinical Research and Ethical Decision Making-Part I: Deciding Whether to Incorporate Practice-Based Research into Your Clinical Practice

Donna T. Chen1 , 2 , 3 , Bradford B. Worrall1 , 4
  • 1Department of Public Health Sciences, University of Virginia, Charlottesville, Virginia
  • 2Center for Biomedical Ethics, University of Virginia, Charlottesville, Virginia
  • 3Department of Psychiatric Medicine, University of Virginia, Charlottesville, Virginia
  • 4Department of Neurology, University of Virginia, Charlottesville, Virginia
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Publication History

Publication Date:
15 February 2006 (online)

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ABSTRACT

Calls for increasing clinical research in routine care settings aim to improve the empirical and ethical foundations of evidence-based practice. In the treatment and prevention of stroke many troubling management questions remain uninvestigated by the clinical research enterprise. Many practicing physicians perceive available data as having limited applicability to their average patients. Recent efforts by the National Institute of Neurological Disorders and Stroke seek to establish clinical research networks that will expand the role of private practice physicians in the conduct of research on stroke and other neurological diseases, akin to practice-based research networks supported by the Agency for Healthcare Research and Quality and other National Institutes of Health institutes. Adding clinical research to one's practice of medicine has practical and ethical implications. Furthermore, because of the growth and expansion of clinical research, all practicing physicians should have a fundamental understanding of clinical research and the differences between clinical care and clinical research, even if they are not directly involved in the conduct of clinical research, to appropriately advise their patients. In this and the following article, we offer two practical frameworks to aid physicians contemplating adding clinical research to their everyday practice of medicine.

KEYWORDS

Practice-based research - research networks - ethics - therapeutic misconception - conflicts of interest - conflicts of commitment - systems-informed professionalism - balanced scorecard

REFERENCES

  • 1 Broderick J, Brott T, Kothari R et al.. The greater Cincinnati/northern Kentucky stroke study: preliminary first-ever and total incidence rates of stroke among blacks.  Stroke. 1998;  29 415-421
    PubMedGoogle Scholar
  • 2 Williams G R. Incidence and characteristics of total stroke in the United States.  BMC Neurol. 2001;  1 2
    CrossrefPubMedGoogle Scholar
  • 3 Kleindorfer D, Panagos P, Pancioli A et al.. Incidence and short-term prognosis of transient ischemic attack in a population-based study.  Stroke. 2005;  36 720-723
    CrossrefPubMedGoogle Scholar
  • 4 Leary M C, Saver J L. Annual incidence of first silent stroke in the United States: a preliminary estimate.  Cerebrovasc Dis. 2003;  16 280-285
    CrossrefPubMedGoogle Scholar
  • 5 Johnston S C, Fung L H, Gillum L A et al.. Utilization of intravenous tissue-type plasminogen activator for ischemic stroke at academic medical centers: the influence of ethnicity.  Stroke. 2001;  32 1061-1068
    PubMedGoogle Scholar
  • 6 Katzan I L, Hammer M D, Hixson E D et al.. Utilization of intravenous tissue plasminogen activator for acute ischemic stroke.  Arch Neurol. 2004;  61 346-350
    CrossrefPubMedGoogle Scholar
  • 7 Centers for Disease Control and Prevention (CDC) . Declining prevalence of no known major risk factors for heart disease and stroke among adults-United States, 1991-2001.  MMWR Morb Mortal Wkly Rep. 2004;  53 4-7
    PubMedGoogle Scholar
  • 8 Institute of Medicine .Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC; National Academy Press 2001
    Google Scholar
  • 9 Smedley B D, Stith A Y, Nelson A R. Institute of Medicine. (U.S.) .Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care. Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. Washington, D.C.; National Academy Press 2003
    Google Scholar
  • 10 Sung N S, Crowley Jr W F, Genel M et al.. Central challenges facing the national clinical research enterprise.  JAMA. 2003;  289 1278-1287
    CrossrefPubMedGoogle Scholar
  • 11 Tunis S R, Stryer D B, Clancy C M. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy.  JAMA. 2003;  290 1624-1632
    CrossrefPubMedGoogle Scholar
  • 12 Sandercock P. What questions can large, simple trials answer?.  Cerebrovasc Dis. 1998;  8(suppl 2) 30-36
    PubMedGoogle Scholar
  • 13 Buring J E, Hennekens C H. The contribution of large, simple trials to prevention research.  Prev Med. 1994;  23 595-598
    CrossrefPubMedGoogle Scholar
  • 14 Peto R, Collins R, Gray R. Large-scale randomized evidence: large, simple trials and overviews of trials.  Ann NY Acad Sci. 1993;  703 314-340
    PubMedGoogle Scholar
  • 15 Nutting P A, Beasley J W, Werner J J. Practice-based research networks answer primary care questions.  JAMA. 1999;  281 686-688
    CrossrefPubMedGoogle Scholar
  • 16 Nutting P A, Baier M, Werner J J et al.. Practice patterns of family physicians in practice-based research networks: a report from ASPN (ambulatory sentinel practice network).  J Am Board Fam Pract. 1999;  12 278-284
    PubMedGoogle Scholar
  • 17 SWOG .The history and evolution of the Southwest Oncology Group. Available at: http://www.swog.org/Visitors/download/policies/Policy00.pdf Accessed August 3, 2005
    Google Scholar
  • 18 AHRQ .Fact sheet: primary care practice-based research networks. Available at: http://www.ahrq.gov/research/pbrnfact.htm Accessed July 25, 2005
    Google Scholar
  • 19 Lanier D. Primary care practice-based research comes of age in the United States.  Ann Fam Med. 2005;  3 S2-S4
    PubMedGoogle Scholar
  • 20 NIH .Re-engineering the clinical research enterprise. NIH Roadmap Initiative 2005
    Google Scholar
  • 21 Mold J W, Peterson K A. Primary care practice-based research networks: working at the interface between research and quality improvement.  Ann Fam Med. 2005;  3(suppl 1) S12-S20
    PubMedGoogle Scholar
  • 22 Kemmis S, McTaggart R. Participatory action research. In: Denzin NK, Lincoln YS Handbook of Qualitative Research. Thousand Oaks, CA; Sage Publications 2000: 567-606
    Google Scholar
  • 23 NHLBI .Ardsnet clinical network. Available at: http://www.ardsnet.org/ Accessed July 22, 2005
    Google Scholar
  • 24 NCI .Cancer therapy evaluation program. Available at: http://ctep.cancer.gov/resources/coop.html Accessed July 22, 2005
    Google Scholar
  • 25 AHRQ .Centers for education and research on therapeutics. Available at: http://www.ahrq.gov/clinic/certsovr.htm2005 Accessed July 22, 2005
    Google Scholar
  • 26 Lader E W, Cannon C P, Ohman E M et al.. The clinician as investigator: participating in clinical trials in the practice setting.  Circulation. 2004;  109 2672-2679
    CrossrefPubMedGoogle Scholar
  • 27 Henry K, Lawyer B L. Subcommittee motAMD. Neurologists 2004: AAN member demographics and practice characteristics. 2005: 11-12
    Google Scholar
  • 28 Marler J R. Help wanted: the best and the brightest neurologists to advance neurological treatments.  Neurology Today. 2005;  5 4
    PubMedGoogle Scholar
  • 29 NINDS .NINDS Clinical Research Collaboration Workshop. Bethesda, MD, October 7-8, 2002. http://Available at: www.ninds.nih.gov/news_and_events/proceedings/2002_clinical_research_workshop.htm Accessed December 19, 2005
    Google Scholar
  • 30 NINDS-Stroke-PRG .Report of the stroke progress review group. 2002 3-7 41-49
    Google Scholar
  • 31 NINDS .Proceedings of the Stroke Disparities Advisory Panel Meeting. Bethesda, MD, November 7-8, 2002. http://Available at: www.ninds.nih.gov/news_and_events/proceedings/stroke_report_nov_2002.htm Accessed December 19, 2005
    Google Scholar
  • 32 Kissela B, Schneider A, Kleindorfer D et al.. Stroke in a biracial population: the excess burden of stroke among blacks.  Stroke. 2004;  35 426-431
    CrossrefPubMedGoogle Scholar
  • 33 White H, Boden-Albala B, Wang C et al.. Ischemic stroke subtype incidence among whites, blacks, and Hispanics: the northern Manhattan study.  Circulation. 2005;  111 1327-1331
    CrossrefPubMedGoogle Scholar
  • 34 NINDS .PAR-05-084: specialized program of translational research in acute stroke. Available at: http://grants.nih.gov/grants.guide/pa-files/PAR-05-084.html Accessed July 17, 2005
    Google Scholar
  • 35 Morin K, Rakatansky H, Riddick Jr F A et al.. Managing conflicts of interest in the conduct of clinical trials.  JAMA. 2002;  287 78-84
    CrossrefPubMedGoogle Scholar
  • 36 Klein J E, Fleischman A R. The private practicing physician-investigator: ethical implications of clinical research in the office setting.  Hastings Cent Rep. 2002;  32 22-26
    PubMedGoogle Scholar
  • 37 Bodenheimer T. Uneasy alliance: clinical investigators and the pharmaceutical industry.  N Engl J Med. 2000;  342 1539-1544
    CrossrefPubMedGoogle Scholar
  • 38 Lightfoot G D, Sanford S M, Shefrin A. Can investigator certification improve the quality of clinical research?.  Qual Manag Health Care. 1999;  7 31-36
    PubMedGoogle Scholar
  • 39 Beach J E. Clinical trials integrity: a CRO perspective.  Account Res. 2001;  8 245-260
    PubMedGoogle Scholar
  • 40 Rettig R A. The industrialization of clinical research.  Health Aff (Millwood). 2000;  19 129-146
    PubMedGoogle Scholar
  • 41 Eichenwald K, Kolata G. Drug trials hide conflicts for doctors. New York Times (print). 1999: 1, 34
    Google Scholar
  • 42 Green L A, White L L, Barry H C, Nease Jr D E, Hudson B L. Infrastructure requirements for practice-based research networks.  Ann Fam Med. 2005;  3(suppl 1) S5-S11
    CrossrefPubMedGoogle Scholar
  • 43 Pace W D, Staton E W, Holcomb S. Practice-based research network studies in the age of HIPAA.  Ann Fam Med. 2005;  3(suppl 1) S38-S45
    CrossrefPubMedGoogle Scholar
  • 44 Wolf L E, Walden J F, Lo B. Human subjects issues and IRB review in practice-based research.  Ann Fam Med. 2005;  3(suppl 1) S30-S37
    CrossrefPubMedGoogle Scholar
  • 45 Wolf L E, Croughan M, Lo B. The challenges of IRB review and human subjects protections in practice-based research.  Med Care. 2002;  40 521-529
    CrossrefPubMedGoogle Scholar
  • 46 Brody H, Miller F G. The clinician-investigator: unavoidable but manageable tension.  Kennedy Inst Ethics J. 2003;  13 329-346
    PubMedGoogle Scholar
  • 47 Chen D T. Practice-based clinical research and ethical decision-making-part II: deciding whether to host a particular research study in your practice.  Semin Neurol. 2005;  , In press
    PubMedGoogle Scholar
  • 48 Chen D T, Miller F G, Rosenstein D L. Clinical research and the physician-patient relationship.  Ann Intern Med. 2003;  138 669-672
    PubMedGoogle Scholar
  • 49 Fleischman A R, Klein J E. Clinical research in the private office setting: ethical issues.  Trans Am Clin Climatol Assoc. 2002;  113 126-135 discussion 135-126
    PubMedGoogle Scholar
  • 50 Miller F G, Brody H. A critique of clinical equipoise: therapeutic misconception in the ethics of clinical trials.  Hastings Cent Rep. 2003;  33 19-28
    PubMedGoogle Scholar
  • 51 Miller F G, Rosenstein D L, DeRenzo E G. Professional integrity in clinical research.  JAMA. 1998;  280 1449-1454
    CrossrefPubMedGoogle Scholar
  • 52 Eichenwald K, Kolata G. A doctor's drug studies turn into fraud. New York Times (print). 1999: A1, A16
    Google Scholar
  • 53 Werhane P, Doering J. Conflicts of interest and conflicts of commitment.  Prof Ethics. 1995;  4 47-81
    PubMedGoogle Scholar
  • 54 Miller F G, Rosenstein D L. The therapeutic orientation to clinical trials.  N Engl J Med. 2003;  348 1383-1386
    CrossrefPubMedGoogle Scholar
  • 55 Appelbaum P S, Lidz C W, Grisso T. Therapeutic misconception in clinical research: frequency and risk factors.  IRB. 2004;  26 1-8
    PubMedGoogle Scholar
  • 56 Appelbaum P S, Roth L H, Lidz C W, Benson P, Winslade W. False hopes and best data: consent to research and the therapeutic misconception.  Hastings Cent Rep. 1987;  17 20-24
    PubMedGoogle Scholar
  • 57 Dresser R. The ubiquity and utility of the therapeutic misconception.  Soc Philos Policy. 2002;  19 271-294
    PubMedGoogle Scholar
  • 58 Lidz C W, Appelbaum P S. The therapeutic misconception: problems and solutions.  Med Care. 2002;  40 V55-V63
    PubMedGoogle Scholar
  • 59 Casarett D, Karlawish J H, Sugarman J. Determining when quality improvement initiatives should be considered research: proposed criteria and potential implications.  JAMA. 2000;  283 2275-2280
    CrossrefPubMedGoogle Scholar
  • 60 Casarett D, Karlawish J H, Sugarman J. Should patients in quality-improvement activities have the same protections as participants in research studies?.  JAMA. 2000;  284 1786-1788
    CrossrefPubMedGoogle Scholar
  • 61 Stimler C. Quality improvement projects: inaction presents the greatest risk.  Arch Intern Med. 2003;  163 2648-2649
    CrossrefPubMedGoogle Scholar
  • 62 Lynn J. When does quality improvement count as research? Human subject protection and theories of knowledge.  Qual Saf Health Care. 2004;  13 67-70
    CrossrefPubMedGoogle Scholar
  • 63 Lo B, Groman M. Oversight of quality improvement: focusing on benefits and risks.  Arch Intern Med. 2003;  163 1481-1486
    PubMedGoogle Scholar
  • 64 Bellin E, Dubler N N. The quality improvement-research divide and the need for external oversight.  Am J Public Health. 2001;  91 1512-1517
    PubMedGoogle Scholar
  • 65 Bradley E H, Webster T R, Baker D et al.. Translating research into practice: speeding the adoption of innovative health care programs.  Issue Brief (Commonw Fund). 2004;  (724) 1-12
    PubMedGoogle Scholar
  • 66 Chen D T, Mills A E, Werhane P H. Towards systems-informed professionalism. In: Mills AE, Chen DT, Werhane P, Wynia M Professionalism in Tomorrow's Healthcare System: Towards Fulfilling the ACGME Requirements for Systems-Based Practice and Professionalism. Hagerstown, MD; University Publishing Group 2005
    Google Scholar
  • 67 Pink G H, McKillop I, Schraa E G et al.. Creating a balanced scorecard for a hospital system.  J Health Care Finance. 2001;  27 1-20
    PubMedGoogle Scholar
  • 68 Zelman W N, Pink G H, Matthias C B. Use of the balanced scorecard in health care.  J Health Care Finance. 2003;  29 1-16
    PubMedGoogle Scholar
  • 69 Zelman W N, Blazer D, Gower J M, Bumgarner P O, Cancilla L M. Issues for academic health centers to consider before implementing a balanced-scorecard effort.  Acad Med. 1999;  74 1269-1277
    PubMedGoogle Scholar
  • 70 Clark P A. Can organizational ethics programs influence management initiatives?.  Organizational Ethics: Healthcare, Business, and Policy. 2005;  2 59-71
    PubMedGoogle Scholar
  • 71 Biro L A, Moreland M E, Cowgill D E. Achieving excellence in veterans healthcare: a balanced scorecard approach.  J Healthc Qual. 2003;  25 33-39
    PubMedGoogle Scholar
  • 72 Meliones J N, Ballard R, Liekweg R, Burton W. No mission-no margin: it's that simple.  J Health Care Finance. 2001;  27 21-29
    PubMedGoogle Scholar
  • 73 Meliones J. Saving money, saving lives.  Harv Bus Rev. 2000;  78 57-62
    PubMedGoogle Scholar
  • 74 Rimar S, Garstka S J. The “balanced scorecard”: development and implementation in an academic clinical department.  Acad Med. 1999;  74 114-122
    PubMedGoogle Scholar
  • 75 Zbinden A M. Introducing a balanced scorecard management system in a university anesthesiology department.  Anesth Analg. 2002;  95 1731-1738
    PubMedGoogle Scholar
  • 76 Chang A C. How to start and sustain a successful pediatric cardiac intensive care program: a combined clinical and administrative strategy.  Pediatr Crit Care Med. 2002;  3 107-111
    PubMedGoogle Scholar
  • 77 Rimar S. Strategic planning and the balanced scorecard for faculty practice plans.  Acad Med. 2000;  75 1186-1188
    PubMedGoogle Scholar
  • 78 Mills A E, Chen D T, Werhane P H, Wynia M K. Professionalism in Tomorrow's Healthcare System: Towards Fulfilling the ACGME Requirements for and Systems-Based Practice and Professionalism. Hagerstown, MD; University Publishing Group 2005
    Google Scholar
  • 79 Berwick D M. Crossing the boundary: changing mental models in the service of improvement.  Int J Qual Health Care. 1998;  10 435-441
    CrossrefPubMedGoogle Scholar
  • 80 Berwick D M. A user's manual for the iom's “quality chasm” report.  Health Aff (Millwood). 2002;  21 80-90
    CrossrefPubMedGoogle Scholar
  • 81 Hahn D L. Physician opportunity costs for performing practice-based research.  J Fam Pract. 2000;  49 983-984
    PubMedGoogle Scholar
  • 82 Chen D T. Curricular approaches to research ethics training for psychiatric investigators.  Psychopharmacology (Berl). 2003;  171 112-119
    CrossrefPubMedGoogle Scholar

Donna T ChenM.D. M.P.H. 

Center for Biomedical Ethics, University of Virginia, PO Box 800758, Charlottesville, Virginia 22908

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