title: Debating clinical utility.
abstract: The clinical utility of genetic tests is determined by the outcomes following test use. Like other measures of value, it is often contested. Stakeholders may have different views about benefits and risks and about the importance of social versus health outcomes. They also commonly disagree about the evidence needed to determine whether a test is effective in achieving a specific outcome. Questions may be presented as factual disagreements, when they are actually debates about what information matters or how facts should be interpreted and used in clinical decision-making. Defining the different issues at stake is therefore an important element of policy-making. Key issues include evidence standards for test use, and in particular, the circumstances under which prospective controlled data should be required, as well as evidence on feasibility, cost and equitable delivery of testing; the goals of population-based screening programs, and in particular, the role of social outcomes in evaluating test value; and the appropriate uses and funding of tests that inform non-medical actions. Addressing each of these issues requires attention to stakeholder values and methods for effective deliberation that incorporate consumer as well as health professional perspectives.
authors.affiliation: Department of Bioethics and Humanities, University of Washington, Seattle, Wash. 98195-7120, USA. wburke@u.washington.edu
authors.forename: Wylie
authors.initials: W
authors.lastname: Burke
authors.forename: A-M
authors.initials: AM
authors.lastname: Laberge
authors.forename: N
authors.initials: N
authors.lastname: Press
mesh_terms: D003657:Decision Making / Q000941:ethics*; D003661:Decision Support Techniques; D019317:Evidence-Based Medicine; D005817:Genetic Counseling; D005821:Genetic Techniques; D005820:Genetic Testing / Q000941:ethics* / Q000379:methods*; D006291:Health Policy; D006801:Humans; D007231:Infant, Newborn; D015997:Neonatal Screening / Q000941:ethics*; D010358:Patient Participation; D012306:Risk; D018570:Risk Assessment
references.citation: Genet Med. 2007 Oct;9(10):675-81
references.pmid: 18073580
references.citation: Pediatrics. 2006 May;117(5 Pt 2):S350-4
references.pmid: 16735262
references.citation: J Gen Intern Med. 2009 May;24(5):543-9
references.pmid: 19255811
references.citation: N Engl J Med. 1970 Mar 12;282(11):596-9
references.pmid: 4244215
references.citation: N Engl J Med. 2009 Feb 19;360(8):753-64
references.pmid: 19228618
references.citation: N Engl J Med. 2009 Jul 16;361(3):298-9
references.pmid: 19605835
references.citation: Aust J Fam Law. 2005 Dec;19(3):195-212
references.pmid: 17058348
references.citation: N Engl J Med. 2009 Feb 19;360(8):811-3
references.pmid: 19228625
references.citation: N Engl J Med. 2008 Jan 10;358(2):105-7
references.pmid: 18184955
references.citation: J Public Health (Oxf). 2007 Sep;29(3):246-50
references.pmid: 17526507
references.citation: Genet Med. 2009 Jan;11(1):66-73
references.pmid: 19125125
references.citation: N Engl J Med. 2005 Sep 1;353(9):867-70
references.pmid: 16135829
references.citation: Genet Med. 2006 Jul;8(7):448-50
references.pmid: 16845278
references.citation: J Clin Oncol. 2007 Nov 20;25(33):5287-312
references.pmid: 17954709
references.citation: N Engl J Med. 1999 Jul 1;341(1):28-37
references.pmid: 10387940
references.citation: JAMA. 2008 Dec 10;300(22):2669-71
references.pmid: 19066388
references.citation: BMJ. 2007 Aug 4;335(7613):219-20
references.pmid: 17626055
references.citation: Am J Med Genet A. 2006 Apr 15;140(8):914-22
references.pmid: 16528755
references.citation: Ann N Y Acad Sci. 1996 Dec 16;802:149-76
references.pmid: 8993494
references.citation: J Eval Clin Pract. 2006 Jun;12(3):248-56
references.pmid: 16722902
references.citation: Arch Pediatr Adolesc Med. 2007 Aug;161(8):767-72
references.pmid: 17679658
references.citation: Pediatrics. 2006 May;117(5):1793-9
references.pmid: 16651338
references.citation: Genet Med. 2005 May-Jun;7(5):295-301
references.pmid: 15915080
references.citation: Diabetes Care. 2009 Apr;32(4):597-9
references.pmid: 19131458
references.citation: Science. 2008 Nov 7;322(5903):881-8
references.pmid: 18988837
references.citation: J Clin Oncol. 2006 Oct 10;24(29):4775-82
references.pmid: 16840542
references.citation: PLoS Med. 2009 Aug;6(8):e1000138
references.pmid: 19707267
references.citation: Cancer Epidemiol Biomarkers Prev. 2007 Sep;16(9):1727-9
references.pmid: 17855689
references.citation: Pathology. 2008 Feb;40(2):104-15
references.pmid: 18203033
references.citation: JAMA. 1997 Mar 12;277(10):832-6
references.pmid: 9052715
references.citation: J Gen Intern Med. 2009 May;24(5):656-64
references.pmid: 19306050
references.citation: Genet Med. 2009 May;11(5):365-70
references.pmid: 19452622
references.citation: J Child Fam Nurs. 1999 Sep-Oct;2(5):388-90
references.pmid: 10795196
references.citation: Science. 2003 Oct 24;302(5645):599-601
references.pmid: 14576422
references.citation: Technol Eval Cent Assess Program Exec Summ. 2008 Apr;22(13):1-8
references.pmid: 18663816
references.citation: Am J Public Health. 2005 Nov;95(11):1889-93
references.pmid: 16195526
references.citation: Pediatrics. 2006 May;117(5):1800-5
references.pmid: 16651339
references.citation: Pediatrics. 2006 Mar;117(3):923-9
references.pmid: 16510675
references.citation: Am J Epidemiol. 2002 Aug 15;156(4):311-8
references.pmid: 12181100
references.citation: N Engl J Med. 2009 Jul 16;361(3):245-54
references.pmid: 19605829
references.citation: Science. 2004 Oct 22;306(5696):640-3
references.pmid: 15499008
references.citation: J Geriatr Psychiatry Neurol. 2005 Dec;18(4):250-5
references.pmid: 16306249
references.citation: Annu Rev Genomics Hum Genet. 2008;9:161-82
references.pmid: 18767961
references.citation: Genet Test. 1999;3(1):3-12
references.pmid: 10464572
references.citation: Ann Intern Med. 2009 Jan 20;150(2):73-83
references.pmid: 19153410
references.citation: N Engl J Med. 2008 Mar 6;358(10):1061-3
references.pmid: 18322288
references.citation: AIDS. 2008 Oct 1;22(15):2025-33
references.pmid: 18784465
references.citation: Genet Med. 2008 Dec;10(12):874-8
references.pmid: 19092439
references.citation: Clin Biochem Rev. 2009 May;30(2):55-65
references.pmid: 19565025
references.citation: Health Aff (Millwood). 2005 Mar-Apr;24(2):483-90
references.pmid: 15757934
references.citation: N Engl J Med. 2005 Jun 2;352(22):2285-93
references.pmid: 15930419
references.citation: Genet Med. 2009 Jan;11(1):3-14
references.pmid: 18813139
references.citation: Cancer Epidemiol Biomarkers Prev. 2009 Jul;18(7):1953-61
references.pmid: 19567511
references.citation: N Engl J Med. 2005 Sep 15;353(11):1105-13
references.pmid: 16162881
references.citation: Am J Med Genet C Semin Med Genet. 2009 Feb 15;151C(1):95-103
references.pmid: 19170092
references.citation: J Mol Diagn. 2009 Jul;11(4):263-5
references.pmid: 19541920
references.citation: JAMA. 2007 Oct 10;298(14):1682-4
references.pmid: 17925520
references.citation: Community Genet. 2006;9(2):93-7
references.pmid: 16612059
references.citation: Genet Med. 2005 Nov-Dec;7(9):605-10
references.pmid: 16301861
references.citation: Nat Rev Genet. 2007 Feb;8(2):151-7
references.pmid: 17230201
references.citation: J Law Med Ethics. 2005 Winter;33(4 Suppl):46-8
references.pmid: 16689158
references.citation: JAMA. 2008 Mar 19;299(11):1351-2
references.pmid: 18349096
references.citation: Hastings Cent Rep. 1999 Sep-Oct;29(5):S1-22
references.pmid: 10587809
references.citation: Prev Chronic Dis. 2005 Apr;2(2):A04
references.pmid: 15888215
references.citation: Ann Intern Med. 2009 Mar 3;150(5):351-2
references.pmid: 19258561
references.citation: Pharmacogenomics. 2009 Feb;10(2):235-41
references.pmid: 19207024
references.citation: Nat Genet. 2008 Aug;40(8):939-42
references.pmid: 18665132
references.citation: J Inherit Metab Dis. 2007 Aug;30(4):613
references.pmid: 17632692
references.citation: Pharmacotherapy. 2008 Feb;28(2):141-3
references.pmid: 18225960
references.citation: J Clin Endocrinol Metab. 2001 Dec;86(12):5658-71
references.pmid: 11739416