The shortcomings of clinical practice guidelines

Cardiology (Switzerland)

Volumn 130, Issue 3, 2015, Pages 187-200

  Boudoulas, Konstantinos Dean ^a   Leier, Carl V ^a   Geleris, Paraschos ^b   Boudoulas, Harisios ^a,b  

^a OHIO STATE UNIVERSITY   (United States)

^b ARISTOTLE UNIVERSITY OF THESSALONIKI   (Greece)

Author keywords

Clinical experience; Clinical practice guidelines; Randomized controlled studies; Relative risk reduction; Statistical significance

Indexed keywords

ARTICLE; CARDIAC PATIENT; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); FINANCIAL MANAGEMENT; HEALTH CARE; HEART FAILURE; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; LEFT VENTRICULAR SYSTOLIC DYSFUNCTION; LONG TERM CARE; MEDICAL STAFF; OUTCOME ASSESSMENT; PATIENT MONITORING; POPULATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGISTER; REVASCULARIZATION; CARDIOLOGY; CLINICAL COMPETENCE; PHYSICIAN;

CARDIOLOGY; CLINICAL COMPETENCE; HUMANS; PHYSICIANS; PRACTICE GUIDELINES AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84925397414     PISSN: 00086312     EISSN: 14219751     Source Type: Journal    
DOI: 10.1159/000371572     Document Type: Article

References (74)

1. Wooley CF, Boudoulas H: Clinician. Helenic J Cardiol 1993; 34:241-243.
2. Wooley CF, Sparks EA, Olsen S, Boudoulas H: A cardiovascular teaching laboratory: the master class in ambulatory teaching. Hellenic J Cardiol 2008; 48:7-16.
3. Jacobs AK, Anderson JL, Halperin JL: The evolution and future of ACC/AHA clinical practice guidelines: a 30-year journey: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014; 13014:1208-1217.
4. DeMaria AN: Clinical trials and clinical judgment. J Am Coll Cardiol 2008; 51:1120-1122.
5. Lewis HD Jr, Davis JW, Archibald DG, Stein-ke WE, Smitherman TC, Doherty JE 3rd, Schnaper HW, LeWinter MM, Linares E, Pouget JM, Sabharwal SC, Chesler E, DeMots H: Protective effects of aspirin against acute myocardial infarction and death in men with unstable angina. Results of a Veterans Administration Cooperative Study. N Engl J Med 1983; 309:396-403.
6. Fuster V: A second dilemma in cardiovascular medicine. Personalized medicine versus personal interaction with the patient. J Am Coll Cardiol 2014; 64:1292-1293.
7. Sniderman AD, Furberg CD: Why guideline-making requires reform. JAMA 2009; 301: 429-431.
8. Gibbons GH, Harold JC, Jessup M, Robertson RM, Oetgen W: The next steps in developing clinical practice guidelines for prevention. J Am Coll Cardiol 2013; 62:1399-1400.
9. Rose G: Sick individuals and sick populations. Int J Epidemiol 1985; 14:32-38.
10. Geleris P, Boudoulas H: Problems related to the application of guidelines in clinical practice: a critical analysis. Hellenic J Cardiol 2011; 52:97-102.
11. Burgers JS, Bailey JV, Klazinga NS, Van Der Bij AK, Grol R, Feder G; AGREE COLLABORATION: Inside guidelines: comparative analysis of recommendations and evidence in diabetes guidelines from 13 countries. Diabetes Care 2002; 25:1933-1939.
12. Clifton L: Do clinical trials work? New York Times Sunday Review, July 13, 2013.
13. Detsky AS: Sources of bias for authors of clinical practice guidelines. Can Med Assoc J 2006; 175:1033-1034.
14. Gibbons GH, Shurin SB, Mensah GA, Lauer MS: Reforming the agenda on cardiovascular guidelines. An announcement from the National Heart, Lung, and Blood Institute. Circulation 2013; 128:1713-1715.
15. Bourton I, Dutton S, Ravaud P, Altman DG: Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA 2010; 303:2058-2064.
16. Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction. Gruppo Italiano per Io Studio dela Streptochinasi nell'Infarto Miocardio (GISSI). Lancet 1986;i:397-402.
17. Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators. N Engl J Med 1989; 321:406-412.
18. Effect of Enalapril on mortality and the development of heart failure in asymptomatic patients with reduced left ventricular ejection fractions. The SOLVD Investigators. N Engl J Med 1992; 327:685-691.
19. Randomised trial of intravenous streptoki-nase, oral aspirin, both, or neither among 17, 187 cases of suspected acute myocardial infarction: ISIS-2. ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. Lancet 1988;ii:349-360.
20. McAlister FA, van Diepen S, Padwal RS, Johnson JA, Majumdar SR: How evidence-based are the recommendations in evidence-based guidelines? PLoS Med 2007; 4:e250.
21. Ellrodt AG, Fonarow GC, Schwamm LH, Albert N, Bhatt DL, Cannon CP, Hernandez AF, Hlatky MA, Luepker RV, Peterson PN, Reeves M, Smith EE: Synthesizing lessons learned from get with the guidelines: the value of disease-based registries in improving quality outcomes. Circulation 2013; 128: 2447-2460.
22. Bekelman JE, Li Y, Gross CO: Scope and impact of financial conflicts of interest in bio-medical research: a systematic review. JAMA 2003; 289:1167-1170.
23. Leopold SS: Testing for the presence of positive-outcome bias in peer review: a randomized controlled trial. Arch Intern Med 2010; 170:1934-1939.
24. Avorn J, Choudhry NK: Funding for medical education: maintaining a healthy separation from industry. Circulation 2010; 121:2228-2234.
25. Choudhry NK, Stelfox HT, Detsky AS: Relationships between authors of clinical practice guidelines and the pharmaceutical industry. JAMA 2002; 87:612-617.
26. Glickman SW, McHutchison J, Peterson ED, Cairns CB, Harrington RA, Califf RM, Schul-man KA: Ethical and scientific implications of the globalization of clinical research. N Engl J Med 2009; 360:816-823.
27. Zhang D, Yin P, Freemantle N, Jordan R, Zhong N, Cheng KK: An assessment of the quality of randomized controlled trials conducted in China. Trials 2008; 9:22.
28. Stakos D, Boudoulas H: Pharmacogenetics and pharmacogenomics in cardiology. Hellenic J Cardiol 2002; 43:1-15.
29. Johnson JA: Ethnic differences in cardiovascular drug response. Potential contribution of pharmacogenetics. Circulation 2008; 118: 1383-1393.
30. Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Wein-traub WS; COURAGE Trial Research Group: Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med 2007; 356:1503-1516.
31. Arnet DK, Goodman RA, Halperin JL, Anderson JL, Parekh AK, Zoghbi WA: AHA/ACC/HHS strategies to enhance application of clinical practice guidelines in patients with cardiovascular disease and comorbid conditions: from the American Heart Association, American College of Cardiology, and U.S. Department of Health and Human Services. J Am Coll Cardiol 2014; 64: 1851-1856.
32. Goldacre B: Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients. New York, Faber & Faber, 2012.
33. Ioannidis J: Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials. JAMA 1998; 279:281-286.
34. Kasenda B, von Elm E, You J, Blümle A, To-monaga Y, Saccilotto R, Amstutz A, Ben-gough T, Meerpohl JJ, Stegert M, Tikkinen KA, Neumann I, Carrasco-Labra A, Faulha-ber M, Mulla SM, Mertz D, Akl EA, Bassler D, Busse JW, Ferreira-González I, Lamontagne F, Nordmann A, Gloy V, Raatz H, Moja L, Rosenthal R, Ebrahim S, Schandelmaier S, Xin S, Vandvik PO, Johnston BC, Walter MA, Burnand B, Schwenkglenks M, Hemkens LG, Bucher HC, Guyatt GH, Briel M: Prevalence, characteristics, and publication of discontin ued randomized trials. JAMA 2014; 311: 1045-1051.
35. Bassler D, Briel M, Montori VM, Lane M, Glasziou P, Zhou Q, Heels-Ansdell D, Wal ter SD, Guyatt GH; STOPIT-2 Study Group, Flynn DN, Elamin MB, Murad MH, Abu Elnour NO, Lampropulos JF, Sood A, Mullan RJ, Erwin PJ, Bankhead CR, Perera R, Ruiz Culebro C, You JJ, Mulla SM, Kaur J, Nerenberg KA, Schünemann H, Cook DJ, Lutz K, Ribic CM, Vale N, Malaga G, Akl EA, Ferreira-Gonzalez I, Alonso-Coello P, Urrutia G, Kunz R, Bucher HC, Nordmann AJ, Raatz H, da Silva SA, Tuche F, Strahm B, Djulbegovic B, Adhikari NK, Mills EJ, Gwadry-Sridhar F, Kirpalani H, Soares HP, Karanicolas PJ, Burns KE, Vandvik PO, Coto-Yglesias F, Chrispim PP, Ramsay T: Stopping ran domized trials early for benefit and estima tion of treatment effects: systematic review and meta-regression analysis. JAMA 2010; 303: 1180-1187.
36. Cohen D: Dabigatran: how the drug company withheld important analysis. BMJ 2014; 249: g4670.
37. Moore TJ, Cohen MR, Mattison DR: Dabiga-tran, bleeding and the regulators. BMJ 2014; 349: g4517.
38. Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B: Evidence b(i)ased medicine-selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003; 326:1171-1173.
39. Mitka M: FDA takes slow road toward withdrawal of drug approved with fast-track process. JAMA 2011; 305:982-984.
40. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Maru-sic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB; International Committee of Medical Journal Editors: Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Lancet 2004; 364:911-912.
41. Prayle AP, Hurley MN, Smyth AR: Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ 2012; 344:d7373.
42. Gibson L: UK government fails to tackle weaknesses in drug industry. BMJ 2005; 331: 534-540.
43. Strom BL, Buyse M, Hughes J, Knoppers BM: Data sharing, year 1-access to data from industry-sponsored clinical trials. N Engl J Med 2014; 371:2052-2054.
44. Shekelle PG, Ortiz E, Rhores S, Morton SC, Eccles MP, Grimshaw JM, Woolf SH: Validity of the Agency for Healthcare Research and Quality clinical practice guidelines: how quickly do guidelines become outdates? JAMA 2001; 286:1461-1467.
45. Bourgeois FT, Murthy S, Mandl KD: Outcome reporting among drug trials registered in Clinical Trials.gov. Ann Intern Med 2010; 153:158-166.
46. Becker JE, Krumholz HM, Ben-Josef G, Ross JS: Reporting of results in ClinicalTrials.gov and high-impact journals. JAMA 2014; 311: 1063-1065.
47. Berkson J: The calculation of survival rates; in Walters W, Gray HK, Prstley JT (eds): Carcinomas and Other Malignant Lesions of the Stomach. Philadelphia, Saunders, 1942, pp 467-484.
48. Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53:457-481.
49. Mantel N, Haenszel W: Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 1959; 22:719-748.
50. Weissler AN, Miller BI, Boudoulas H: The need for clarification of percent reduction data in clinical cardiovascular trial reports. J Am Coll Cardiol 1989; 13:764-766.
51. Boudoulas H, Lewis RP: The interpretations of prognostic studies; in Warren JV, Lewis RP (eds): Diagnostic Procedures in Cardiology: A Clinician's Guide. Chicago, Year Book Medical Publishers, 1985, pp 378-385.
52. Altman D: Statistics and ethics in medical research. IV. Presentation of results. Br Med J 1980; 281:1542-1544.
53. Schühlen H: Pre-specified vs. post-hoc subgroup analyses: are we wiser before or after a trial has been performed? Eur Heart J 2014; 35: 2055-2057.
54. Rothwell PM: Subgroup analysis in randomized controlled trials: importance, indications, and interpretation. Lancet 2005; 365: 176-186.
55. Pocock SJ, Gersh B: Do current clinical trials meet society's needs? A critical review of recent evidence. J Am Coll Cardiol 2014; 64: 1615-1628.
56. Tavazzi L: Do we need clinical registries? Eur Heart J 2014; 35:7-9.
57. Staa TP, Goldacre B, Gulliford M, Cassell J, Pirmohamed M, Taweel A, Delaney B, Smeeth L: Pragmatic randomized trials using routine electronic health records: putting them to the test. BMJ 2012; 344:e55.
58. Mendelson TB, Meltzer M, Campbell EG, Ca-plan AL, Kirkpatrick JN: Conflicts of interest in cardiovascular clinical practice guidelines. Arch Intern Med 2011; 171:577-585.
59. Nissen SE: Can we trust cardiovascular practice guidelines? Arch Intern Med 2011; 171: 384-385.
60. Wislar JS, Flanagin A, Fountanarosa PB, DeAngelis CD: Honorary and ghost authorship in high impact biomedical journals: a cross sectional survey. BMJ 2011; 343:d6128.
61. Loewenstein G, Sah S, Cain DM: The unintended consequences of conflict of interest disclosure. JAMA 2012; 307:669-670.
62. Boudoulas KD, Geleris P, Boudoulas H: Medical education: eternal values. Hellenic J Car-diol 2012; 53:173-178.
63. Prasad V, Vandross A, Toomey C, Cheung M, Rho J, Quinn S, Chacko SJ, Borkar D, Gall V, Selvaraj S, Ho N, Cifu A: A decade of reversal: an analysis of 146 contradicted medical practices. Mayo Clin Proc 2013; 88:790-798.
64. Shaneyfelt TM, Centor RM: Reassessment of clinical practice guidelines: go gently into that good night. JAMA 2009; 301:868-869.
65. Shanyefeltt TM, Mayo-Smith MF, Rothwangl J: Are guidelines following guidelines? The methodological quality of clinical practice guidelines in the peer-reviewed medical literature. JAMA 1999; 281:1900-1905.
66. Gibbons GH, Shurin SB, Mensah GA, Lauer MS: Refocusing the agenda on cardiovascular guidelines: an announcement from the National Heart, Lung, and Blood Institute. J Am Coll Cardiol 2013; 62:1396-1398.
67. Weisz G, Cambrosio A, Keating P, Knaapen L, Schlich T, Tournay VJ: The emergence of clinical practice guidelines. Milbank Q 2007; 85:691-727.
68. Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW: Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases. JAMA 2005; 294:716-724.
69. Juurlink DN, Gomes T, Ko DT, Szmitko PE, Austin PC, Tu JV, Henry DA, Kopp A, Mam-dani MM: A population-based study of the drug interaction between proton pump inhibitors and clopidogrel. CMAJ 2009; 180:713-718.
70. Ho PM, Maddox TM, Wang L, Fihn SD, Jesse RL, Peterson ED, Rumsfeld JS: Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA 2009; 301:937-944.
71. Eddy DM, Adler J, Patterson B, Lucas D, Smith KA, Morris M: Individualized guidelines: the potential for increasing quality and reducing costs. Ann Intern Med 2011; 154: 638-639.
72. King SB 3rd, Lembo NJ, Weintraub WS, Ko-sinski AS, Barnhart HX, Kutner MH, Alazraki NP, Guyton RA, Zhao XQ: A randomized trial comparing coronary angioplasty with coronary bypass surgery. Emory Angioplasty versus Surgery Trial (EAST). N Engl J Med 1994; 331:1044-1050.
73. Pereira AC, Lopes NH, Soares PR, Krieger JE, de Oliveira SA, Cesar LA, Ramires JA, Hueb W: Clinical judgment and treatment options in stable multivessel coronary artery disease: results from the one-year follow-up of the MASS II (Medicine, Angioplasty, or Surgery Study II). J Am Coll Cardiol 2006; 48:948-953.
74. Boudoulas H: Therapeutic interventions which may improve survival in patients with coronary artery disease. Acta Cardiol 1990; 45: 477-487.