Medical Malpractice Implications of PSA Testing for Early Detection of Prostate Cancer

Journal of Law, Medicine and Ethics

Volumn 25, Issue 4, 1997, Pages 234-242

  Collins, Mary McNaughton ^a   Fowler Jr , Floyd J ^a   Roberts, Richard G ^a   Oesterling, Joseph E ^a   Annas, George J ^a   Barry, Michael J ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

PROSTATE SPECIFIC ANTIGEN; TUMOR MARKER;

ADULT; AGED; ARTICLE; BLOOD; CLINICAL PRACTICE; FEMALE; HUMAN; MALE; MALPRACTICE; MIDDLE AGED; PROSTATE HYPERTROPHY; PROSTATE TUMOR; STATISTICS; UNITED STATES;

ADULT; AGED; FEMALE; HUMANS; MALE; MALPRACTICE; MASSACHUSETTS; MIDDLE AGED; PHYSICIAN'S PRACTICE PATTERNS; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC HYPERPLASIA; PROSTATIC NEOPLASMS; TUMOR MARKERS, BIOLOGICAL;

EID: 0031290286     PISSN: 10731105     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1748-720X.1997.tb01405.x     Document Type: Article

References (72)

1. E.D. Pellegrino, Editorial, "Can the Doctor's Burden Be Shifted to the Patient?," Pharos, Spring (1993): at 34.
2. See S.L. Parker et al., "Cancer Statistics, 1996," CA: A Cancer Journal for Clinicians, 46 (1996): 5-27.
3. See S.J. Jacobsen et al., "Incidence of Prostate Cancer Diagnosis in the Eras Before and After Serum Prostate-Specific Antigen Testing," JAMA, 274 (1995): 1445-49; and A.L. Potosky et al., "The Role of Increasing Detection in the Rising Incidence of Prostate Cancer," JAMA, 273 (1995): 548-52.
4. See S.J. Jacobsen et al., "Incidence of Prostate Cancer Diagnosis in the Eras Before and After Serum Prostate-Specific Antigen Testing," JAMA, 274 (1995): 1445-49; and A.L. Potosky et al., "The Role of Increasing Detection in the Rising Incidence of Prostate Cancer," JAMA, 273 (1995): 548-52.
5. See R.M. Merrill et al., "Changing Trends in Prostate Cancer Incidence Rates," Journal of the National Cancer Institute, 88 (1996): 1683-85.
6. See Prostate Health Council, Prostate Cancer: What Every Man Over 40 Should Know (Baltimore: Prostate Health Council, 1994).
7. See A. von Eschenbach et al., "American Cancer Society Guideline for the Early Detection of Prostate Cancer: Update 1997," CA: A Cancer Journal for Clinicians, 47 (1997): 261-64.
8. See U.S. Preventive Services Task Force, "Screening for Prostate Cancer," in Guide to Clinical Preventive Services (Baltimore: Williams and Wilkins, 2nd ed., 1996): 119-34; C.M. Coley et al., "Early Detection of Prostate Cancer. Part I: Prior Probability and Performance of Tests," Annals of Internal Medicine, 126 (1997): 394-406; and C.M. Coley et al., "Early Detection of Prostate Cancer. Part II: Estimating the Risks, Benefits, and Costs," Annals of Internal Medicine, 126 (1997): 468-79.
9. See U.S. Preventive Services Task Force, "Screening for Prostate Cancer," in Guide to Clinical Preventive Services (Baltimore: Williams and Wilkins, 2nd ed., 1996): 119-34; C.M. Coley et al., "Early Detection of Prostate Cancer. Part I: Prior Probability and Performance of Tests," Annals of Internal Medicine, 126 (1997): 394-406; and C.M. Coley et al., "Early Detection of Prostate Cancer. Part II: Estimating the Risks, Benefits, and Costs," Annals of Internal Medicine, 126 (1997): 468-79.
10. See U.S. Preventive Services Task Force, "Screening for Prostate Cancer," in Guide to Clinical Preventive Services (Baltimore: Williams and Wilkins, 2nd ed., 1996): 119-34; C.M. Coley et al., "Early Detection of Prostate Cancer. Part I: Prior Probability and Performance of Tests," Annals of Internal Medicine, 126 (1997): 394-406; and C.M. Coley et al., "Early Detection of Prostate Cancer. Part II: Estimating the Risks, Benefits, and Costs," Annals of Internal Medicine, 126 (1997): 468-79.
11. See American Academy of Family Physicians, Action Policy, Summary of Policy Recommendations for Periodic Health Examination (Kansas City: American Academy of Family Physicians, Nov. 1996, rev. July 1997).
12. See, for example, T.G. Gutheil et al., "Malpractice Prevention Through the Sharing of Uncertainty," N. Engl. J. Med., 311 (1984): 49-51; and J.J. Kelley, Letter, "In Defense of Defensive Medicine," Pharos, Spring (1995): 45-46.
13. See, for example, T.G. Gutheil et al., "Malpractice Prevention Through the Sharing of Uncertainty," N. Engl. J. Med., 311 (1984): 49-51; and J.J. Kelley, Letter, "In Defense of Defensive Medicine," Pharos, Spring (1995): 45-46.
14. See P. Weiler et al., A Measure of Malpractice (Cambridge: Harvard University Press, 1993); N. Summerton, "Positive and Negative Factors in Defensive Medicine: A Questionnaire Study of General Practitioners," British Medical Journal, 310 (1995): 27-29; M.B. Kapp, "Informed Consent to Defensive Medicine: Letting the Patient Decide," Pharos, Spring (1993): 12-14; and T.B. Metzloff, "Defensive Medicine and the Use of Medical Technology: Physician Involvement in Medical Malpractice Litigation" (1994) (unpublished paper commissioned by the Office of Technology Assessment) (on file with author).
15. See P. Weiler et al., A Measure of Malpractice (Cambridge: Harvard University Press, 1993); N. Summerton, "Positive and Negative Factors in Defensive Medicine: A Questionnaire Study of General Practitioners," British Medical Journal, 310 (1995): 27-29; M.B. Kapp, "Informed Consent to Defensive Medicine: Letting the Patient Decide," Pharos, Spring (1993): 12-14; and T.B. Metzloff, "Defensive Medicine and the Use of Medical Technology: Physician Involvement in Medical Malpractice Litigation" (1994) (unpublished paper commissioned by the Office of Technology Assessment) (on file with author).
16. See P. Weiler et al., A Measure of Malpractice (Cambridge: Harvard University Press, 1993); N. Summerton, "Positive and Negative Factors in Defensive Medicine: A Questionnaire Study of General Practitioners," British Medical Journal, 310 (1995): 27-29; M.B. Kapp, "Informed Consent to Defensive Medicine: Letting the Patient Decide," Pharos, Spring (1993): 12-14; and T.B. Metzloff, "Defensive Medicine and the Use of Medical Technology: Physician Involvement in Medical Malpractice Litigation" (1994) (unpublished paper commissioned by the Office of Technology Assessment) (on file with author).
17. See P. Weiler et al., A Measure of Malpractice (Cambridge: Harvard University Press, 1993); N. Summerton, "Positive and Negative Factors in Defensive Medicine: A Questionnaire Study of General Practitioners," British Medical Journal, 310 (1995): 27-29; M.B. Kapp, "Informed Consent to Defensive Medicine: Letting the Patient Decide," Pharos, Spring (1993): 12-14; and T.B. Metzloff, "Defensive Medicine and the Use of Medical Technology: Physician Involvement in Medical Malpractice Litigation" (1994) (unpublished paper commissioned by the Office of Technology Assessment) (on file with author).
18. See T.A. Brennan, Just Doctoring: Medical Ethics in the Liberal State (Berkeley: University of California Press, 1991): at 135; There is simply no acceptable method for defining or measuring the extent and cost of defensive medicine, although the U.S. Office of Technology Assessment has suggested that the upper bound on the frequency of diagnostic defensive medicine is less than 8 percent of all diagnostic procedures. Because approximately one trillion dollars will be spent on health care in 1997, however, 8 percent is still a substantial amount. Office of Technology Assessment, Defensive Medicine and Medical Malpractice (Washington, D.C.: Office of Technology Assessment, 1994): at 3. Defensive medicine can also be divided into two types: positive defensive acts done because of perceived malpractice risk, such as diagnosis tests; and negative defensive practices not performed because of perceived malpractice risk. See R.J. Rubin and D.N. Mendelson, Estimating the Costs of Defensive Medicine (Fairfax: Lewin-VHI, 1993). It has also been suggested that failure to follow up on abnormal test results may actually be a greater source of legal liability than not performing the tests in the first place. See generally, for example, W.M. Robertson, Medical Malpractice: A Preventive Approach (Seattle: University of Washington Press, 1985); and J.E. Harris, "Defensive Medicine: It Costs, But Does It Work?," JAMA, 257 (1987): 2801-02. All of this, of course, makes this an extremely perilous area to study.
19. See T.A. Brennan, Just Doctoring: Medical Ethics in the Liberal State (Berkeley: University of California Press, 1991): at 135; There is simply no acceptable method for defining or measuring the extent and cost of defensive medicine, although the U.S. Office of Technology Assessment has suggested that the upper bound on the frequency of diagnostic defensive medicine is less than 8 percent of all diagnostic procedures. Because approximately one trillion dollars will be spent on health care in 1997, however, 8 percent is still a substantial amount. Office of Technology Assessment, Defensive Medicine and Medical Malpractice (Washington, D.C.: Office of Technology Assessment, 1994): at 3. Defensive medicine can also be divided into two types: positive defensive acts done because of perceived malpractice risk, such as diagnosis tests; and negative defensive practices not performed because of perceived malpractice risk. See R.J. Rubin and D.N. Mendelson, Estimating the Costs of Defensive Medicine (Fairfax: Lewin-VHI, 1993). It has also been suggested that failure to follow up on abnormal test results may actually be a greater source of legal liability than not performing the tests in the first place. See generally, for example, W.M. Robertson, Medical Malpractice: A Preventive Approach (Seattle: University of Washington Press, 1985); and J.E. Harris, "Defensive Medicine: It Costs, But Does It Work?," JAMA, 257 (1987): 2801-02. All of this, of course, makes this an extremely perilous area to study.
20. See T.A. Brennan, Just Doctoring: Medical Ethics in the Liberal State (Berkeley: University of California Press, 1991): at 135; There is simply no acceptable method for defining or measuring the extent and cost of defensive medicine, although the U.S. Office of Technology Assessment has suggested that the upper bound on the frequency of diagnostic defensive medicine is less than 8 percent of all diagnostic procedures. Because approximately one trillion dollars will be spent on health care in 1997, however, 8 percent is still a substantial amount. Office of Technology Assessment, Defensive Medicine and Medical Malpractice (Washington, D.C.: Office of Technology Assessment, 1994): at 3. Defensive medicine can also be divided into two types: positive defensive acts done because of perceived malpractice risk, such as diagnosis tests; and negative defensive practices not performed because of perceived malpractice risk. See R.J. Rubin and D.N. Mendelson, Estimating the Costs of Defensive Medicine (Fairfax: Lewin-VHI, 1993). It has also been suggested that failure to follow up on abnormal test results may actually be a greater source of legal liability than not performing the tests in the first place. See generally, for example, W.M. Robertson, Medical Malpractice: A Preventive Approach (Seattle: University of Washington Press, 1985); and J.E. Harris, "Defensive Medicine: It Costs, But Does It Work?," JAMA, 257 (1987): 2801-02. All of this, of course, makes this an extremely perilous area to study.
21. See T.A. Brennan, Just Doctoring: Medical Ethics in the Liberal State (Berkeley: University of California Press, 1991): at 135; There is simply no acceptable method for defining or measuring the extent and cost of defensive medicine, although the U.S. Office of Technology Assessment has suggested that the upper bound on the frequency of diagnostic defensive medicine is less than 8 percent of all diagnostic procedures. Because approximately one trillion dollars will be spent on health care in 1997, however, 8 percent is still a substantial amount. Office of Technology Assessment, Defensive Medicine and Medical Malpractice (Washington, D.C.: Office of Technology Assessment, 1994): at 3. Defensive medicine can also be divided into two types: positive defensive acts done because of perceived malpractice risk, such as diagnosis tests; and negative defensive practices not performed because of perceived malpractice risk. See R.J. Rubin and D.N. Mendelson, Estimating the Costs of Defensive Medicine (Fairfax: Lewin-VHI, 1993). It has also been suggested that failure to follow up on abnormal test results may actually be a greater source of legal liability than not performing the tests in the first place. See generally, for example, W.M. Robertson, Medical Malpractice: A Preventive Approach (Seattle: University of Washington Press, 1985); and J.E. Harris, "Defensive Medicine: It Costs, But Does It Work?," JAMA, 257 (1987): 2801-02. All of this, of course, makes this an extremely perilous area to study.
22. See T.A. Brennan, Just Doctoring: Medical Ethics in the Liberal State (Berkeley: University of California Press, 1991): at 135; There is simply no acceptable method for defining or measuring the extent and cost of defensive medicine, although the U.S. Office of Technology Assessment has suggested that the upper bound on the frequency of diagnostic defensive medicine is less than 8 percent of all diagnostic procedures. Because approximately one trillion dollars will be spent on health care in 1997, however, 8 percent is still a substantial amount. Office of Technology Assessment, Defensive Medicine and Medical Malpractice (Washington, D.C.: Office of Technology Assessment, 1994): at 3. Defensive medicine can also be divided into two types: positive defensive acts done because of perceived malpractice risk, such as diagnosis tests; and negative defensive practices not performed because of perceived malpractice risk. See R.J. Rubin and D.N. Mendelson, Estimating the Costs of Defensive Medicine (Fairfax: Lewin-VHI, 1993). It has also been suggested that failure to follow up on abnormal test results may actually be a greater source of legal liability than not performing the tests in the first place. See generally, for example, W.M. Robertson, Medical Malpractice: A Preventive Approach (Seattle: University of Washington Press, 1985); and J.E. Harris, "Defensive Medicine: It Costs, But Does It Work?," JAMA, 257 (1987): 2801-02. All of this, of course, makes this an extremely perilous area to study.
23. See, for example, U.E. Reinhardt, "Reforming the Health Care System," American Journal of Law & Medicine, XIX (1993): 21-36. This, of course, is the rationale for using financial incentives to affect physician behavior. See also E.P. Richard, "Do Physicians Really Care about Medical Malpractice Litigation?," Preventive Law Reporter, Spring (1993): at 3 (stating "The self- serving nature of the defensive medicine argument is obvious when one realizes that third-party insurers pay for these tests. Unnecessary tests increase the profitability of the hospital or the independent lab.").
24. See, for example, U.E. Reinhardt, "Reforming the Health Care System," American Journal of Law & Medicine, XIX (1993): 21-36. This, of course, is the rationale for using financial incentives to affect physician behavior. See also E.P. Richard, "Do Physicians Really Care about Medical Malpractice Litigation?," Preventive Law Reporter, Spring (1993): at 3 (stating "The self-serving nature of the defensive medicine argument is obvious when one realizes that third-party insurers pay for these tests. Unnecessary tests increase the profitability of the hospital or the independent lab.").
25. See D. Klingman et al., "Measuring Defensive Medicine Using Clinical Scenario Surveys," Journal of Health Politics, Policy and Law, 21 (1996): 185-217; R.R. Bovbjerg et al., "Defensive Medicine and Tort Reform: New Evidence in an Old Bottle," Journal of Health Politics, Policy and Law, 21 (1996): 267-88; P.A. Glassman et al., "Physicians' Personal Malpractice Experiences Are Not Related to Defensive Clinical Practices," Journal of Health Politics, Policy and Law, 21 (1996): 219-38; P.D. Jacobson et al., "The Use of Low-Osmolar Contrast Agents: Technological Change and Defensive Medicine," Journal of Health Politics, Policy and Law, 21 (1996): 243-66; and see J.D. Voss, "Prostate Cancer, Screening, and Prostate-Specific Antigen: Promise or Peril?," Journal of General Internal Medicine, 9 (1994): 468-74.
26. See D. Klingman et al., "Measuring Defensive Medicine Using Clinical Scenario Surveys," Journal of Health Politics, Policy and Law, 21 (1996): 185-217; R.R. Bovbjerg et al., "Defensive Medicine and Tort Reform: New Evidence in an Old Bottle," Journal of Health Politics, Policy and Law, 21 (1996): 267-88; P.A. Glassman et al., "Physicians' Personal Malpractice Experiences Are Not Related to Defensive Clinical Practices," Journal of Health Politics, Policy and Law, 21 (1996): 219-38; P.D. Jacobson et al., "The Use of Low-Osmolar Contrast Agents: Technological Change and Defensive Medicine," Journal of Health Politics, Policy and Law, 21 (1996): 243-66; and see J.D. Voss, "Prostate Cancer, Screening, and Prostate-Specific Antigen: Promise or Peril?," Journal of General Internal Medicine, 9 (1994): 468-74.
27. See D. Klingman et al., "Measuring Defensive Medicine Using Clinical Scenario Surveys," Journal of Health Politics, Policy and Law, 21 (1996): 185-217; R.R. Bovbjerg et al., "Defensive Medicine and Tort Reform: New Evidence in an Old Bottle," Journal of Health Politics, Policy and Law, 21 (1996): 267-88; P.A. Glassman et al., "Physicians' Personal Malpractice Experiences Are Not Related to Defensive Clinical Practices," Journal of Health Politics, Policy and Law, 21 (1996): 219-38; P.D. Jacobson et al., "The Use of Low-Osmolar Contrast Agents: Technological Change and Defensive Medicine," Journal of Health Politics, Policy and Law, 21 (1996): 243-66; and see J.D. Voss, "Prostate Cancer, Screening, and Prostate-Specific Antigen: Promise or Peril?," Journal of General Internal Medicine, 9 (1994): 468-74.
28. See D. Klingman et al., "Measuring Defensive Medicine Using Clinical Scenario Surveys," Journal of Health Politics, Policy and Law, 21 (1996): 185-217; R.R. Bovbjerg et al., "Defensive Medicine and Tort Reform: New Evidence in an Old Bottle," Journal of Health Politics, Policy and Law, 21 (1996): 267-88; P.A. Glassman et al., "Physicians' Personal Malpractice Experiences Are Not Related to Defensive Clinical Practices," Journal of Health Politics, Policy and Law, 21 (1996): 219-38; P.D. Jacobson et al., "The Use of Low-Osmolar Contrast Agents: Technological Change and Defensive Medicine," Journal of Health Politics, Policy and Law, 21 (1996): 243-66; and see J.D. Voss, "Prostate Cancer, Screening, and Prostate-Specific Antigen: Promise or Peril?," Journal of General Internal Medicine, 9 (1994): 468-74.
29. See D. Klingman et al., "Measuring Defensive Medicine Using Clinical Scenario Surveys," Journal of Health Politics, Policy and Law, 21 (1996): 185-217; R.R. Bovbjerg et al., "Defensive Medicine and Tort Reform: New Evidence in an Old Bottle," Journal of Health Politics, Policy and Law, 21 (1996): 267-88; P.A. Glassman et al., "Physicians' Personal Malpractice Experiences Are Not Related to Defensive Clinical Practices," Journal of Health Politics, Policy and Law, 21 (1996): 219-38; P.D. Jacobson et al., "The Use of Low-Osmolar Contrast Agents: Technological Change and Defensive Medicine," Journal of Health Politics, Policy and Law, 21 (1996): 243-66; and see J.D. Voss, "Prostate Cancer, Screening, and Prostate-Specific Antigen: Promise or Peril?," Journal of General Internal Medicine, 9 (1994): 468-74.
30. See, for example, L. Berlin et al., "Malpractice and Radiologists in Cook County, IL: Trends in 20 Years of Litigation," American Journal of Radiology, 165 (1995): 781-88.
31. See, for example, D.B. Troxel et al., "Problem Areas in Pathology Practice: Uncovered by a Review of Malpractice Claims," American Journal of Surgical Pathology, 18 (1994): 821-31.
32. See, for example, K. Kern, "Medical Malpractice Involving Colon and Rectal Disease: A 20-Year Review of United States Civil Court Litigation," Diseases of the Colon and Rectum, 36 (1993): 531-39; and K.A. Kern et al., "Medicolegal Analysis of the Delayed Diagnosis of Cancer in 338 Cases in the United States," Archives of Surgery, 129 (1994): 397-404.
33. See, for example, K. Kern, "Medical Malpractice Involving Colon and Rectal Disease: A 20-Year Review of United States Civil Court Litigation," Diseases of the Colon and Rectum, 36 (1993): 531-39; and K.A. Kern et al., "Medicolegal Analysis of the Delayed Diagnosis of Cancer in 338 Cases in the United States," Archives of Surgery, 129 (1994): 397-404.
34. See, for example, K.V. Heland, "Medicolegal Issues," Obstetrics and Gynecology Clinics of North America, 21 (1994): 781-88; and L.M. Baldwin et al., "Defensive Medicine in Obstetrics," JAMA, 274 (1995): 1606-10.
35. See, for example, K.V. Heland, "Medicolegal Issues," Obstetrics and Gynecology Clinics of North America, 21 (1994): 781-88; and L.M. Baldwin et al., "Defensive Medicine in Obstetrics," JAMA, 274 (1995): 1606-10.
36. See T.A. Brennan et al., "Medical Malpractice Reform: The Current Proposals," Journal of General Internal Medicine, 10 (1995): 211-18.
37. See Physician Insurers Association of America Data Sharing Committee, Cumulative Reports Jan. 1, 1985-June 30, 1996 (Rockville: Physician Insurers Association of America, 1996).
38. See G.J. Annas, "Breast Cancer Screening in Older Women: Law and Patient Rights," Journal of Gerontology, 47 (1992): 121-25.
39. See J.D. Reeves et al., "Legal Implications of Prostate Cancer: What You Should Know," Virginia Medical Quarterly, 120 (1993): 77-79. Of course, the breach of duty must also cause harm to the patient.
40. See G.J. Annas et al., American Health Law (Boston: Little Brown, 1990): at 377-415; G.J. Annas, The Rights of Patients (Carbondale: Southern Illinois Press, 2nd ed., 1989): at 240; and see E.D. Kinney and M.M. Wilder, "Medical Standard Setting in the Current Malpractice Environment: Problems and Possibilities," University of California at Davis Law Review, 22 (1989): 421-50.
41. See G.J. Annas et al., American Health Law (Boston: Little Brown, 1990): at 377-415; G.J. Annas, The Rights of Patients (Carbondale: Southern Illinois Press, 2nd ed., 1989): at 240; and see E.D. Kinney and M.M. Wilder, "Medical Standard Setting in the Current Malpractice Environment: Problems and Possibilities," University of California at Davis Law Review, 22 (1989): 421-50.
42. See G.J. Annas et al., American Health Law (Boston: Little Brown, 1990): at 377-415; G.J. Annas, The Rights of Patients (Carbondale: Southern Illinois Press, 2nd ed., 1989): at 240; and see E.D. Kinney and M.M. Wilder, "Medical Standard Setting in the Current Malpractice Environment: Problems and Possibilities," University of California at Davis Law Review, 22 (1989): 421-50.
43. See J.B. Meigs et al., "Interpreting Results of Prostate-Specific Antigen Testing for Early Detection of Prostate Cancer," Journal of General Internal Medicine, 11 (1996): 505-12.
44. See M.J. Barry et al., "A Nationwide Survey of Practicing Urologists: Current Management of Benign Prostatic Hyperplasia and Clinically Localized Prostate Cancer," Journal of Urology, 158 (1997): 488-92; M.M. Collins et al., "Diagnosis and Treatment of Benign Prostatic Hyperplasia: Practice Patterns of Primary Care Physicians," Journal of General Internal Medicine, 12 (1997): 224-29; and F.J. Fowler Jr. et al., "Early Detection Practice Patterns and Treatment Beliefs Among Primary Care Physicians about Prostate Cancer: Results of a National Survey of Physicians," American Journal of Medicine, (1998) (in press) (on file with author).
45. See M.J. Barry et al., "A Nationwide Survey of Practicing Urologists: Current Management of Benign Prostatic Hyperplasia and Clinically Localized Prostate Cancer," Journal of Urology, 158 (1997): 488-92; M.M. Collins et al., "Diagnosis and Treatment of Benign Prostatic Hyperplasia: Practice Patterns of Primary Care Physicians," Journal of General Internal Medicine, 12 (1997): 224-29; and F.J. Fowler Jr. et al., "Early Detection Practice Patterns and Treatment Beliefs Among Primary Care Physicians about Prostate Cancer: Results of a National Survey of Physicians," American Journal of Medicine, (1998) (in press) (on file with author).
46. See M.J. Barry et al., "A Nationwide Survey of Practicing Urologists: Current Management of Benign Prostatic Hyperplasia and Clinically Localized Prostate Cancer," Journal of Urology, 158 (1997): 488-92; M.M. Collins et al., "Diagnosis and Treatment of Benign Prostatic Hyperplasia: Practice Patterns of Primary Care Physicians," Journal of General Internal Medicine, 12 (1997): 224-29; and F.J. Fowler Jr. et al., "Early Detection Practice Patterns and Treatment Beliefs Among Primary Care Physicians about Prostate Cancer: Results of a National Survey of Physicians," American Journal of Medicine, (1998) (in press) (on file with author).
47. J.D. McConnell et al., Benign Prostatic Hyperplasia: Diagnosis and Treatment (Rockville: Agency for Health Care Policy and Research, Clinical Practice Guideline No. 8, AHCPR Pub. No. 94-0582, 1994).
48. Personal communication with Maureen Mondor, Barbara Ricci, and Liz Kelly, ProMutual Group, Boston (July 1996-Aug. 1997) (on file with author); and personal communication with Priscilla Dasse and Lynn Volk, Controlled Risk Insurance Company, Boston (July 1996-Aug. 1997) (on file with author).
49. See B. Rosner, Fundamentals of Biostatistics (Boston: PWS-Kent, 1990).
50. See M.J. Barry et al., "Should Medicare Provide Reimbursement for Prostate-Specific Antigen Testing for Early Detection of Prostate Cancer? Part I: Framing the Debate," Urology, 46 (1995): 2-13.
51. See von Eschenbach et al., supra note 6.
52. See M.J. Barry, "Epidemiology and Natural History of Benign Prostatic Hyperplasia," Urologic Clinics of North America, 17 (1990): 495-507.
53. See von Eschenbach et al., supra note 6.
54. See id.
55. See P.D. Sershon et al., "Preoperative Serum Prostate-Specific Antigen: A Comparison Between Men with Benign Prostatic Hyperplasia and Patients with Organ-Confined Prostate Cancer," European Urology, 25 (1994): 281-87; and J.E. Oesterling et al., "PSA-Detected (Clinical Stage T1c or B0) Prostate Cancer: Pathologically Significant Tumors," Urologic Clinics of North America, 20 (1993): 687-93.
56. See P.D. Sershon et al., "Preoperative Serum Prostate- Specific Antigen: A Comparison Between Men with Benign Prostatic Hyperplasia and Patients with Organ-Confined Prostate Cancer," European Urology, 25 (1994): 281-87; and J.E. Oesterling et al., "PSA-Detected (Clinical Stage T1c or B0) Prostate Cancer: Pathologically Significant Tumors," Urologic Clinics of North America, 20 (1993): 687-93.
57. See C. Mettlin et al., "The American Cancer Society National Prostate Cancer Detection Project. Findings on the Detection of Early Prostate Cancer in 2425 Men," Cancer, 67 (1991): 2949-58; and W.J. Catalona et al., "Comparison of Digital Rectal Examination and Serum Prostate Specific Antigen in the Early Detection of Prostate Cancer: Results of a Multicenter Clinical Trial of 6,630 Men," Journal of Urology, 151 (1994): 1283-90.
58. See C. Mettlin et al., "The American Cancer Society National Prostate Cancer Detection Project. Findings on the Detection of Early Prostate Cancer in 2425 Men," Cancer, 67 (1991): 2949-58; and W.J. Catalona et al., "Comparison of Digital Rectal Examination and Serum Prostate Specific Antigen in the Early Detection of Prostate Cancer: Results of a Multicenter Clinical Trial of 6,630 Men," Journal of Urology, 151 (1994): 1283-90.
59. See P.J. Edwards et al., "Screening, Ethics, and the Law: Ensure that Subjects Know What's Going On," British Medical Journal, 305 (1992): 267-68. It should be emphasized that mere failure to offer prostate-specific antigen (PSA) screening is insufficient to win a malpractice suit, even if PSA is the standard of care. The patient must also prove that he has prostate cancer and his outcome would have been better had the PSA test been done, and that he would have consented to have the test.
60. See J.H. Wasson et al., "A Structured Literature Review of Treatment for Localized Prostate Cancer," Archives of Family Medicine, 2 (1993): 487-93.
61. See Bovbjerg et al., supra note 13.
62. See D. Reintgen et al., "The Medical Legal Implications of Following Mammographic Breast Masses," American Surgeon, 59 (1993): 99-105.
63. See Physician Insurers Association of America, Breast Cancer Study: June 1995 (Washington, D.C.: Physician Insurers Association of America, 1995).
64. See S.F. Records, News, "Female Breast Cancer is Most Prevalent Cause of Malpractice Claims," Journal of the Oklahoma State Medical Association, 88 (1995): 311-12.
65. See Kern et al. (1994), supra note 16.
66. D.L. Hahn and R.G. Roberts, "PSA Screening for Asymptomatic Prostate Cancer: Truth in Advertising," Journal of Family Practice, 37 (1993): 432-36.
67. See Annas, supra note 20; and Truman v. Thomas, 27 Cal. 3d 285, 165 Cal. Rptr. 308, 611 P.2d 902 (1980) (citing informed refusal required for recommended Papanicolaou smear).
68. See S.H. Woolf, "Screening for Prostate Cancer with Prostate Specific Antigen: An Examination of the Evidence," N. Engl. J. Med., 333 (1995): 1401-05; A.B. Flood et al., "The Importance of Patient Preference in the Decision to Screen for Prostate Cancer," Journal of General Internal Medicine, 11 (1996): 342-49; and A.M.D. Wolf et al., "The Impact of Informed Consent on Patient Interest in Prostate-Specific Antigen Screening," Archives of Internal Medicine, 156 (1996): 1333- 36. One of the major challenges for medicine in the coming decades is to develop ways to ensure informed consent and informed refusal for the emerging genetic tests done not to determine a disease state, but to determine a "predisposition" to a disease. Our experience with PSA testing may provide guidance in this area as well. See S. Elias and G.J. Annas, "Generic Consent for Genetic Screening," N. Engl. J. Med., 330 (1994): 1611-13.
69. See S.H. Woolf, "Screening for Prostate Cancer with Prostate Specific Antigen: An Examination of the Evidence," N. Engl. J. Med., 333 (1995): 1401-05; A.B. Flood et al., "The Importance of Patient Preference in the Decision to Screen for Prostate Cancer," Journal of General Internal Medicine, 11 (1996): 342-49; and A.M.D. Wolf et al., "The Impact of Informed Consent on Patient Interest in Prostate-Specific Antigen Screening," Archives of Internal Medicine, 156 (1996): 1333- 36. One of the major challenges for medicine in the coming decades is to develop ways to ensure informed consent and informed refusal for the emerging genetic tests done not to determine a disease state, but to determine a "predisposition" to a disease. Our experience with PSA testing may provide guidance in this area as well. See S. Elias and G.J. Annas, "Generic Consent for Genetic Screening," N. Engl. J. Med., 330 (1994): 1611-13.
70. See S.H. Woolf, "Screening for Prostate Cancer with Prostate Specific Antigen: An Examination of the Evidence," N. Engl. J. Med., 333 (1995): 1401-05; A.B. Flood et al., "The Importance of Patient Preference in the Decision to Screen for Prostate Cancer," Journal of General Internal Medicine, 11 (1996): 342-49; and A.M.D. Wolf et al., "The Impact of Informed Consent on Patient Interest in Prostate-Specific Antigen Screening," Archives of Internal Medicine, 156 (1996): 1333-36. One of the major challenges for medicine in the coming decades is to develop ways to ensure informed consent and informed refusal for the emerging genetic tests done not to determine a disease state, but to determine a "predisposition" to a disease. Our experience with PSA testing may provide guidance in this area as well. See S. Elias and G.J. Annas, "Generic Consent for Genetic Screening," N. Engl. J. Med., 330 (1994): 1611-13.
71. See S.H. Woolf, "Screening for Prostate Cancer with Prostate Specific Antigen: An Examination of the Evidence," N. Engl. J. Med., 333 (1995): 1401-05; A.B. Flood et al., "The Importance of Patient Preference in the Decision to Screen for Prostate Cancer," Journal of General Internal Medicine, 11 (1996): 342-49; and A.M.D. Wolf et al., "The Impact of Informed Consent on Patient Interest in Prostate-Specific Antigen Screening," Archives of Internal Medicine, 156 (1996): 1333- 36. One of the major challenges for medicine in the coming decades is to develop ways to ensure informed consent and informed refusal for the emerging genetic tests done not to determine a disease state, but to determine a "predisposition" to a disease. Our experience with PSA testing may provide guidance in this area as well. See S. Elias and G.J. Annas, "Generic Consent for Genetic Screening," N. Engl. J. Med., 330 (1994): 1611-13.
72. See Gutheil et al., supra note 9, at 51.