Promoting an ethical approach to unproven screening imaging tests
2005; Elsevier BV; Volume: 2; Issue: 4 Linguagem: Inglês
10.1016/j.jacr.2004.09.012
ISSN1558-349X
Autores Tópico(s)Healthcare cost, quality, practices
ResumoThe use of screening imaging technology such as electron beam computed tomography and computed tomographic scans for the early detection of coronary artery disease, lung cancer, and other diseases is rising, even though they have not been proven to reduce disease-specific mortality. Until randomized, controlled trials assess the efficacy of these tests as screening tests, they will remain controversial. It is unclear whether the potential benefits of these screening tests outweigh the risks. In a practice environment in which public demand and enthusiasm for screening is high, radiologists can recognize the ethical issues associated with unproven screening imaging tests; understand current national policies toward professionalism and informed and shared decision making for screening; draw on the lessons learned from the proliferation of another unproven screening test, the prostate-specific antigen blood test for prostate cancer; and work with others in the health care system to promote an ethical approach to screening imaging tests. The use of screening imaging technology such as electron beam computed tomography and computed tomographic scans for the early detection of coronary artery disease, lung cancer, and other diseases is rising, even though they have not been proven to reduce disease-specific mortality. Until randomized, controlled trials assess the efficacy of these tests as screening tests, they will remain controversial. It is unclear whether the potential benefits of these screening tests outweigh the risks. In a practice environment in which public demand and enthusiasm for screening is high, radiologists can recognize the ethical issues associated with unproven screening imaging tests; understand current national policies toward professionalism and informed and shared decision making for screening; draw on the lessons learned from the proliferation of another unproven screening test, the prostate-specific antigen blood test for prostate cancer; and work with others in the health care system to promote an ethical approach to screening imaging tests. The rise of screening imaging testsThe use of screening imaging technology such as electron beam computed tomography (EBCT) and computed tomography (CT) scans for the early detection of coronary artery disease, lung cancer, and other diseases is rising, even though they have not been proved to reduce disease-specific mortality [1Lee T.H. Brennan T.A. Direct-to-consumer marketing of high-technology screening tests.N Engl J Med. 2002; 346: 529-531Crossref PubMed Scopus (84) Google Scholar, 2Hillman B.J. CT screening who benefits and who pays.Radiology. 2003; 228: 26-28Crossref PubMed Scopus (15) Google Scholar, 3Forster B.B. Mayo J.R. Rational computed tomography screening in 2003.Can Assoc Radiol J. 2003; 54: 14-17PubMed Google Scholar]. Until randomized, controlled trials assess the efficacy of these tests as screening tests 3Forster B.B. Mayo J.R. Rational computed tomography screening in 2003.Can Assoc Radiol J. 2003; 54: 14-17PubMed Google Scholar], they will remain controversial. It is unclear whether the potential benefits of these screening tests outweigh the risks, which include unnecessary workups for false-positive test results, side effects from unnecessary treatments, unnecessary financial costs from downstream procedures, false reassurance from false-negative test results when noncontrast studies fail to detect solid organ tumors, radiation, and patient anxiety [2Hillman B.J. CT screening who benefits and who pays.Radiology. 2003; 228: 26-28Crossref PubMed Scopus (15) Google Scholar, 3Forster B.B. Mayo J.R. Rational computed tomography screening in 2003.Can Assoc Radiol J. 2003; 54: 14-17PubMed Google Scholar, 4Pennachio D.L. Full-body scans—or scams?.Med Econ. 2002; 9 (August): 62-71Google Scholar, 5Stolberg H.O. Yuppie scans from head to toe unethical entrepreneurism.Can Assoc Radiol J. 2003; 54: 10-13PubMed Google Scholar, 6Pelletier A.L. Potter A.P. Self-referred screening CT scans in an unselected population.Am Fam Phys. 2002; 66: 1156PubMed Google Scholar]. Yet some physicians are ordering these screening tests, and some patients are self-referring and even paying out of pocket for them 1Lee T.H. Brennan T.A. Direct-to-consumer marketing of high-technology screening tests.N Engl J Med. 2002; 346: 529-531Crossref PubMed Scopus (84) Google Scholar]. Media attention and direct-to-consumer advertising through radio, the Internet, and print media have contributed to an increased demand for these tests at a time when physicians and hospitals, feeling economic pressures from the health care environment, are willing to sell preventive health care services from which they might financially gain [1Lee T.H. Brennan T.A. Direct-to-consumer marketing of high-technology screening tests.N Engl J Med. 2002; 346: 529-531Crossref PubMed Scopus (84) Google Scholar, 2Hillman B.J. CT screening who benefits and who pays.Radiology. 2003; 228: 26-28Crossref PubMed Scopus (15) Google Scholar, 7Schwartz L.M. Woloshin S. Fowler F.J. Welch H.G. Enthusiasm for cancer screening in the United States.JAMA. 2004; 291: 71-78Crossref PubMed Scopus (532) Google Scholar, 8Levin D.C. Me and my MRI. New York Times, 2004: A19Google Scholar].Despite professional guidelines against screening lung, heart, and whole-body scans 3Forster B.B. Mayo J.R. Rational computed tomography screening in 2003.Can Assoc Radiol J. 2003; 54: 14-17PubMed Google Scholar], some physicians are even self-referring patients to imaging facilities that they have invested in for these services 8Levin D.C. Me and my MRI. New York Times, 2004: A19Google Scholar]. They reason 1Lee T.H. Brennan T.A. Direct-to-consumer marketing of high-technology screening tests.N Engl J Med. 2002; 346: 529-531Crossref PubMed Scopus (84) Google Scholar], “If patients are willing to pay, why not offer it to them?” Others believe that screening “works.” At least it gives people “peace of mind” 1Lee T.H. Brennan T.A. Direct-to-consumer marketing of high-technology screening tests.N Engl J Med. 2002; 346: 529-531Crossref PubMed Scopus (84) Google Scholar]. Such reasoning and behavior have the potential to undermine a physician’s ethical duty to uphold the principles of nonmaleficence and patient autonomy and can lead to situations in which physicians fail to uphold professional ethics and inadvertently create gaps in patient care.In a practice environment in which public demand and enthusiasm for screening are high 7Schwartz L.M. Woloshin S. Fowler F.J. Welch H.G. Enthusiasm for cancer screening in the United States.JAMA. 2004; 291: 71-78Crossref PubMed Scopus (532) Google Scholar], what can radiologists do? They can recognize the ethical issues associated with unproven screening imaging tests; understand current national policies toward professionalism and informed decision making (IDM) and shared decision making (SDM) for screening; draw on the lessons learned from the proliferation of another unproven screening test, the prostate-specific antigen (PSA) blood test for prostate cancer; and work with others in the health care system to promote an ethical approach to screening imaging tests.Ethical issues associated with unproven screening imaging testsA fundamental ethical issue concerning unproven screening imaging tests is whether it is appropriate to offer them to the general public before their net benefit or efficacy at reducing disease-specific mortality has been proven through clinical trials. People in favor of offering them argue that screening imaging tests are another commodity in the marketplace that consumers can choose to purchase from providers 1Lee T.H. Brennan T.A. Direct-to-consumer marketing of high-technology screening tests.N Engl J Med. 2002; 346: 529-531Crossref PubMed Scopus (84) Google Scholar]. In this less paternalistic model 5Stolberg H.O. Yuppie scans from head to toe unethical entrepreneurism.Can Assoc Radiol J. 2003; 54: 10-13PubMed Google Scholar] of a patient-physician relationship, patients have the right to new screening technology as long as they can pay for it.People against offering unproven screening imaging tests say that the practice of medicine is not a marketplace commodity to be sold but rather a profession with physician responsibilities that include an altruistic commitment to patients 1Lee T.H. Brennan T.A. Direct-to-consumer marketing of high-technology screening tests.N Engl J Med. 2002; 346: 529-531Crossref PubMed Scopus (84) Google Scholar]. Physicians have a responsibility to uphold the principle of nonmaleficence, expressed as “Primum non nocere,” or “Above all [or first], do no harm” 9Beauchamp T.L. Childress J.F. Nonmaleficence.in: Principles of biomedical ethics. 4th ed. Oxford University Press, Oxford (UK)1994: 189-258Google Scholar]. Offering unproven screening imaging tests that lack specificity can lead to high rates of false-positive test results, undue worry about disease, and unnecessary follow-up testing 1Lee T.H. Brennan T.A. Direct-to-consumer marketing of high-technology screening tests.N Engl J Med. 2002; 346: 529-531Crossref PubMed Scopus (84) Google Scholar].Others argue that physicians who recommend screening tests that lack evidence for a net benefit tend to focus more on what screening and early detection could do for “sick” people than on what screening and potential risks do to “healthy” people. This focus runs counter to the principle of nonmaleficence [10Chan E.C.Y. Informed consent and prostate specific antigen screening.in: Thompson I.M. Resnick M.I. Klein E.A. Prostate cancer screening. Humana Press, Totowa (NJ)2001: 223-238Crossref Google Scholar, 11Malm H.M. Medical screening and value of early detection. When unwarranted faith leads to unethical recommendations.Hastings Center Rep. 1999; 29: 26-37Crossref PubMed Scopus (37) Google Scholar]. There are several potential harms of screening. The early detection of diseases for which there is no, or only rarely successful, treatment may cause anxiety because patients will know for a longer period of time that they have diseases for which little can be done [10Chan E.C.Y. Informed consent and prostate specific antigen screening.in: Thompson I.M. Resnick M.I. Klein E.A. Prostate cancer screening. Humana Press, Totowa (NJ)2001: 223-238Crossref Google Scholar, 11Malm H.M. Medical screening and value of early detection. When unwarranted faith leads to unethical recommendations.Hastings Center Rep. 1999; 29: 26-37Crossref PubMed Scopus (37) Google Scholar]. A patient may receive unnecessary treatment or overtreatment, which is defined as a treatment that the patient would have never received had he or she not been screened and from which there was no net benefit [10Chan E.C.Y. Informed consent and prostate specific antigen screening.in: Thompson I.M. Resnick M.I. Klein E.A. Prostate cancer screening. Humana Press, Totowa (NJ)2001: 223-238Crossref Google Scholar, 11Malm H.M. Medical screening and value of early detection. When unwarranted faith leads to unethical recommendations.Hastings Center Rep. 1999; 29: 26-37Crossref PubMed Scopus (37) Google Scholar]. A patient may undergo a procedure for the removal of a lesion or cancer that was the preferred method of treatment at the time of diagnosis but later was shown to be a more aggressive or more damaging procedure than was needed [10Chan E.C.Y. Informed consent and prostate specific antigen screening.in: Thompson I.M. Resnick M.I. Klein E.A. Prostate cancer screening. Humana Press, Totowa (NJ)2001: 223-238Crossref Google Scholar, 11Malm H.M. Medical screening and value of early detection. When unwarranted faith leads to unethical recommendations.Hastings Center Rep. 1999; 29: 26-37Crossref PubMed Scopus (37) Google Scholar]. Early detection does not necessarily mean “better care.”Physicians ought to be concerned about social justice, about the whole class of patients, not just the ones who are potential candidates for screening, and as such, they ought to consider the impact of recommending unproven screening imaging tests on the limited resources of the health care system. Unproven screening imaging tests can boost health care costs because follow-up testing and care are often paid for by public or private health insurance, even though a patient may have paid out of pocket for the initial screening 2Hillman B.J. CT screening who benefits and who pays.Radiology. 2003; 228: 26-28Crossref PubMed Scopus (15) Google Scholar]. Expending health care dollars on patients who are potential candidates for unproven screening imaging tests diverts resources from proven screening tests and patients who lack care 1Lee T.H. Brennan T.A. Direct-to-consumer marketing of high-technology screening tests.N Engl J Med. 2002; 346: 529-531Crossref PubMed Scopus (84) Google Scholar].On a societal level, a premature recommendation for screening can reduce the chance that a randomized, controlled trial of a screening test can be completed to determine whether there is a net benefit on a population level. If people come to believe that a test is beneficial, they may be less willing to be assigned to the control group [10Chan E.C.Y. Informed consent and prostate specific antigen screening.in: Thompson I.M. Resnick M.I. Klein E.A. Prostate cancer screening. Humana Press, Totowa (NJ)2001: 223-238Crossref Google Scholar, 11Malm H.M. Medical screening and value of early detection. When unwarranted faith leads to unethical recommendations.Hastings Center Rep. 1999; 29: 26-37Crossref PubMed Scopus (37) Google Scholar]. This concern has already been raised with clinical trials for some screening tests [10Chan E.C.Y. Informed consent and prostate specific antigen screening.in: Thompson I.M. Resnick M.I. Klein E.A. Prostate cancer screening. Humana Press, Totowa (NJ)2001: 223-238Crossref Google Scholar, 11Malm H.M. Medical screening and value of early detection. When unwarranted faith leads to unethical recommendations.Hastings Center Rep. 1999; 29: 26-37Crossref PubMed Scopus (37) Google Scholar].For characterizing screening tests, there is the issue of how proven is “proven” and how unproven is “unproven.” Independent organizations such as the U.S. Preventive Services Task Force (USPSTF) follow an explicit process that considers the quality of the evidence and the magnitude of the net benefit for a screening test to make a recommendation about it [12Sheridan S.L. Harris R.P. Woolf S.H. Shared Decision Making Workgroup of the US Preventive Services Task ForceShared decision making about screening and chemoprevention A suggested approach from the U.S. Preventive Services Task Force.Am J Prev Med. 2004; 26: 56-66Abstract Full Text Full Text PDF PubMed Scopus (334) Google Scholar, 13Humphrey L.L. Teutsch S. Johnson M. Lung cancer screening with sputum cytologic examination, chest radiography, and computed tomography an update for the U.S. Preventive Services Task Force.Ann Intern Med. 2004; 140: 740-753Crossref PubMed Scopus (187) Google Scholar, 14US Preventive Services Task ForceLung cancer screening recommendation statement.Ann Intern Med. 2004; 140: 738-739Crossref PubMed Scopus (101) Google Scholar]. Radiologists and professional societies can provide screening guidelines to the general public after considering the recommendations of such independent organizations. They can also develop a process of their own to weigh the quality of the evidence for each screening imaging test and assign a point value indicating the level of evidence in support of each test.Regardless of whether screening imaging tests ought to be offered, many are already widely available. This gives rise to another ethical issue: whether radiologists have an ethical obligation to promote informing patients about the potential risks, benefits, and limitations of a test, particularly in cases of patient self-referrals. In short, the response is “yes.” As physicians, radiologists have a duty to uphold the principle of patient autonomy. It is not sufficient to assume that just because a patient has shown up and asks for a screening imaging test that the patient is exercising autonomy. Many patients may not understand the unproven nature and potential risks associated with testing.In a study involving 1,057 audiotaped encounters containing 3,552 clinical decisions between patients and physicians in outpatient practice, Braddock et al.15Braddock C.H. Edwards K.A. Hasenberg N.M. Informed decision making in outpatient practice. Time to get back to basics.JAMA. 1999; 282: 2313-2320Crossref PubMed Scopus (944) Google Scholar] found that 9% of the decisions met criteria for complete IDM, and only 0.5% of complex decisions such as those involving unproven screening tests were completely informed. Given this dismal state of IDM in outpatient clinical practice, patients are unlikely to be informed about the potential risks, benefits, and limitations of an unproven screening imaging examination by the time they show up at imaging centers. They may not have exercised true autonomy in the decision-making process.The physician charter of professionalismIn response to concerns that changes in health care delivery systems, including technological advances and market forces, are threatening the nature and values of medical professionalism, the American Board of Internal Medicine, the American College of Physicians-American Society of Internal Medicine Foundation, and the European Federation of Internal Medicine in 2002 published a physician charter of medical professionalism 16Project of the ABIM Foundation, ACP-ASIM Foundation, and European Federation of Internal MedicineMedical professionalism in the new millennium a physician charter.Ann Intern Med. 2002; 136: 243-246Crossref PubMed Scopus (1537) Google Scholar]. It articulated a set of principles concerning patient welfare, patient autonomy, and social justice, to which all medical professionals should aspire [16Project of the ABIM Foundation, ACP-ASIM Foundation, and European Federation of Internal MedicineMedical professionalism in the new millennium a physician charter.Ann Intern Med. 2002; 136: 243-246Crossref PubMed Scopus (1537) Google Scholar, 17Blank L. Kimball H. McDonald W. Merino J. ABIM Foundation, ACP Foundation, and European Federation of Internal MedicineMedical professionalism in the new millennium a physician charter 15 months later.Ann Intern Med. 2003; 138: 839-841Crossref PubMed Scopus (114) Google Scholar] as part of their moral identity 18Reiser S.J. Banner R.S. The charter on medical professionalism and the limits of medical power.Ann Intern Med. 2003; 138: 844-846Crossref PubMed Scopus (30) Google Scholar].The charter 16Project of the ABIM Foundation, ACP-ASIM Foundation, and European Federation of Internal MedicineMedical professionalism in the new millennium a physician charter.Ann Intern Med. 2002; 136: 243-246Crossref PubMed Scopus (1537) Google Scholar], which has been endorsed by the ACR 17Blank L. Kimball H. McDonald W. Merino J. ABIM Foundation, ACP Foundation, and European Federation of Internal MedicineMedical professionalism in the new millennium a physician charter 15 months later.Ann Intern Med. 2003; 138: 839-841Crossref PubMed Scopus (114) Google Scholar], is relevant to the ethics of unproven screening imaging tests. It states that the principle of the primacy of patient welfare should not be compromised by market forces and societal pressures. Physicians must respect patient autonomy by empowering patients to make informed decisions. Physicians have a commitment to the just distribution of finite resources and ought to consider how the provision of unproven screening imaging tests leads to spiraling health care costs and diminishes the resources available for others [1Lee T.H. Brennan T.A. Direct-to-consumer marketing of high-technology screening tests.N Engl J Med. 2002; 346: 529-531Crossref PubMed Scopus (84) Google Scholar, 16Project of the ABIM Foundation, ACP-ASIM Foundation, and European Federation of Internal MedicineMedical professionalism in the new millennium a physician charter.Ann Intern Med. 2002; 136: 243-246Crossref PubMed Scopus (1537) Google Scholar].IDM and SDM for screeningIn 2004 the Centers for Disease Control and Prevention (CDC), the USPSTF, and the National Cancer Institute (NCI) defined IDM and SDM for screening [12Sheridan S.L. Harris R.P. Woolf S.H. Shared Decision Making Workgroup of the US Preventive Services Task ForceShared decision making about screening and chemoprevention A suggested approach from the U.S. Preventive Services Task Force.Am J Prev Med. 2004; 26: 56-66Abstract Full Text Full Text PDF PubMed Scopus (334) Google Scholar, 19Briss P. Rimer B. Reilley B. et al.for the Task Force on Community Preventive Services. Promoting informed decisions about cancer screening in communities and healthcare systems.Am J Prev Med. 2004; 26: 67-80Abstract Full Text Full Text PDF PubMed Scopus (271) Google Scholar, 20Kaplan R.M. Shared decision making. A new tool for preventive medicine.Am J Prev Med. 2004; 26: 81-82Abstract Full Text Full Text PDF PubMed Scopus (57) Google Scholar, 21Rimer B.K. Briss P.A. Zeller P.K. Chan E. Woolf S.H. Informed decision making what is its role in cancer screening?.Cancer. 2004; 101: 1214-1228Crossref PubMed Scopus (251) Google Scholar]. This development is consistent with the Institute of Medicine’s initiative to promote quality health care, defined as patient-centered care that is respectful of and responsive to patients’ preferences, needs, and values 22Institute of MedicineCrossing the quality chasm a new health system for the 21st century. National Academy Press, Washington (DC)2001Google Scholar]. Several trends have led to this.Technological advances are making it possible to detect disease earlier with more options for screening, even before randomized, controlled trials have proven the efficacy of some screening tests. Additionally, screening decisions are getting more complex. For colorectal cancer screening, patients have several options to choose from: colonoscopy, flexible sigmoidoscopy, air-contrast barium enemas, fecal occult blood testing, and virtual colonoscopy. Patients must consider potential risks and benefits before taking the PSA test, because clinical trials have not yet determined its efficacy as a screening test 10Chan E.C.Y. Informed consent and prostate specific antigen screening.in: Thompson I.M. Resnick M.I. Klein E.A. Prostate cancer screening. Humana Press, Totowa (NJ)2001: 223-238Crossref Google Scholar]. Controversies [21Rimer B.K. Briss P.A. Zeller P.K. Chan E. Woolf S.H. Informed decision making what is its role in cancer screening?.Cancer. 2004; 101: 1214-1228Crossref PubMed Scopus (251) Google Scholar, 23Humphrey L.L. Helfand M. Chan B.K. Woolf S.H. Breast cancer screening a summary of the evidence for the US Preventive Services Task Force.Ann Intern Med. 2002; 137: 347-360Crossref PubMed Google Scholar, 24Harris R. Leininger L. Clinical strategies for breast cancer screening weighing and using the evidence.Ann Intern Med. 1995; 122: 539-547Crossref PubMed Scopus (71) Google Scholar, 25Morton E. Tambor E. Rimer B.K. 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Breast cancer screening a summary of the evidence for the US Preventive Services Task Force.Ann Intern Med. 2002; 137: 347-360Crossref PubMed Google Scholar], at what age women should get mammograms [21Rimer B.K. Briss P.A. Zeller P.K. Chan E. Woolf S.H. Informed decision making what is its role in cancer screening?.Cancer. 2004; 101: 1214-1228Crossref PubMed Scopus (251) Google Scholar, 24Harris R. Leininger L. Clinical strategies for breast cancer screening weighing and using the evidence.Ann Intern Med. 1995; 122: 539-547Crossref PubMed Scopus (71) Google Scholar, 25Morton E. Tambor E. Rimer B.K. Tessaro I. Farrell D. Siegler I.C. Impact of National Cancer Institute revised mammography screening guidelines on women 40-49.Women Health Iss. 1996; 6: 246-254Abstract Full Text PDF PubMed Scopus (14) Google Scholar, 26Kinsinger L.S. Harris R. Breast cancer screening discussions for women in their forties.Breast Dis. 2001; 13: 21-31PubMed Google Scholar], how often women should get Pap smears [21Rimer B.K. Briss P.A. Zeller P.K. Chan E. Woolf S.H. Informed decision making what is its role in cancer screening?.Cancer. 2004; 101: 1214-1228Crossref PubMed Scopus (251) Google Scholar, 27Saslow D. Runowicz C.D. Solomon D. et al.American Cancer Society guideline for the early detection of cervical neoplasia and cancer.CA Cancer J Clin. 2002; 52: 342-362Crossref PubMed Scopus (802) Google Scholar], and whether there should be upper age limits for these tests 21Rimer B.K. Briss P.A. Zeller P.K. Chan E. Woolf S.H. Informed decision making what is its role in cancer screening?.Cancer. 2004; 101: 1214-1228Crossref PubMed Scopus (251) Google Scholar].As a result, the CDC and the NCI recognize that public health programs for the early detection of some diseases should shift from screening promotion to IDM or SDM for screening. Patients need to make the right decisions for themselves. Each patient needs to make a personal decision about whether testing is appropriate given his or her values and the uncertainties, potential benefits, harms, and limitations of each test 19Briss P. Rimer B. Reilley B. et al.for the Task Force on Community Preventive Services. Promoting informed decisions about cancer screening in communities and healthcare systems.Am J Prev Med. 2004; 26: 67-80Abstract Full Text Full Text PDF PubMed Scopus (271) Google Scholar].Patients have also become more interested in relationships with their physicians that are based on mutual participation rather than on physician paternalism [21Rimer B.K. Briss P.A. Zeller P.K. Chan E. Woolf S.H. Informed decision making what is its role in cancer screening?.Cancer. 2004; 101: 1214-1228Crossref PubMed Scopus (251) Google Scholar, 33Rimer B.K. Keintz M.K. Kessler H.B. Engstrom P.F. Rosan J.R. 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The widespread dissemination of health information through the rise of the Internet, informatics, and communications revolutions has given patients the means to access information that they previously received primarily from their physicians. Encouraged by stronger advocacy groups and a more consumer-oriented approach to health care, many patients expect to participate in decision making with their physicians and to make more informed decisions about their care 21Rimer B.K. Briss P.A. Zeller P.K. Chan E. Woolf S.H. Informed decision making what is its role in cancer screening?.Cancer. 2004; 101: 1214-1228Crossref PubMed Scopus (251) Google Scholar].The Task Force on Community Preventive Services 19Briss P. Rimer B. Reilley B. et al.for the Task Force on Community Preventive Services. Promoting informed decisions about cancer screening in communities and healthcare systems.Am J Prev Med. 2004; 26: 67-80Abstract Full Text Full Text PDF PubMed Scopus (271) Google Scholar] defined IDM as occurring when an individual understands the nature of the disease or condition being addressed; understands the clinical service and its likely conseq
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