Giao thức REFER (REFer để thực hiện siêu âm tim): xác thực diến ra của một quy tắc quyết định lâm sàng, NT-proBNP, hoặc sự kết hợp của chúng, trong việc chẩn đoán suy tim ở tuyến chăm sóc ban đầu. Các lý do và thiết kế
Tóm tắt
Suy tim là nguyên nhân chính gây tử vong và bệnh tật. Do tỷ lệ tử vong cao, việc nhanh chóng xác định và điều trị những bệnh nhân đến gặp bác sĩ đa khoa với triệu chứng gợi ý suy tim là vô cùng quan trọng. Việc xác định bệnh nhân suy tim hoặc quyết định bệnh nhân nào cần được xét nghiệm thêm là một thách thức. Tất cả bệnh nhân nghi ngờ bị suy tim cần được chẩn đoán bằng các xét nghiệm khách quan như siêu âm tim, nhưng điều này thường tốn kém, trễ tràng và bị hạn chế do thiếu hụt nghiêm trọng các chuyên viên siêu âm được đào tạo. Hiện tại, các phương pháp chẩn đoán suy tim thay thế còn hạn chế. Các công cụ quyết định lâm sàng kết hợp các dấu hiệu lâm sàng, triệu chứng hoặc đặc điểm của bệnh nhân được thiết kế để hỗ trợ việc ra quyết định lâm sàng và được xác thực theo các quy trình phương pháp nghiêm ngặt. Nghiên cứu REFER nhằm xác định độ chính xác và hiệu quả chi phí của quy tắc quyết định lâm sàng đơn giản, mới và đã được phát triển trước đó của chúng tôi, một xét nghiệm peptide lợi niệu, hoặc sự kết hợp của chúng, trong việc phân loại bệnh nhân người lớn có triệu chứng trong thực hành tổng quát mà có triệu chứng gợi ý suy tim để chuyển gửi xét nghiệm siêu âm tim.
Từ khóa
#suy tim #quy tắc quyết định lâm sàng #NT-proBNP #siêu âm tim #nghiên cứu lâm sàngTài liệu tham khảo
Task FM, McMurray JJV, Adamopoulos S, Anker SD, Auricchio A, Böhm M, et al: ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012. Eur Heart J. 2012, 33: 1787-1847.
Davies MK, Hobbs FDR, Davis RC, Kenkre JE, Roalfe AK, Hare R, et al: Prevalence of left-ventricular systolic dysfunction and heart failure in the echocardiographic heart of England screening study: a population based study. Lancet. 2001, 358: 439-444. 10.1016/S0140-6736(01)05620-3.
Hobbs FDR, Kenkre JE, Roalfe AK, Davis RC, Hare R, Davies MK: Impact of heart failure and left ventricular systolic dysfunction on quality of life. A cross-sectional study comparing common chronic cardiac and medical disorders and a representative adult population. Eur Heart J. 2002, 23: 1867-1876. 10.1053/euhj.2002.3255.
Stewart S, Jenkins A, Buchan S, McGuire A, Capewell S, McMurray JJJV: The current cost of heart failure to the National Health Service in the UK. Eur J Heart Fail. 2002, 4: 361-371. 10.1016/S1388-9842(01)00198-2.
Fuat A, Hungin AP, Murphy JJ: Barriers to accurate diagnosis and effective management of heart failure in primary care: qualitative study. BMJ. 2003, 326: 196-10.1136/bmj.326.7382.196.
Khunti K, Hearnshaw H, Baker R, Grimshaw G: Heart failure in primary care: qualitative study of current management and perceived obstacles to evidence-based diagnosis and management by general practitioners. Eur J Heart Fail. 2002, 4: 771-777. 10.1016/S1388-9842(02)00119-8.
Remes J, MlEttinen H, Reunanen A, Pyorala K: Validity of clinical diagnosis of heart failure in primary health care. Eur Heart J. 1991, 12: 315-321.
Skaner Y, Bring J, Ullman B, Strender LE: Heart failure diagnosis in primary health care: clinical characteristics of problematic patients. A clinical judgement analysis study. BMC Fam Pract. 2003, 4: 12-10.1186/1471-2296-4-12.
Garg R, Yusuf S: Overview of randomized trials of angiotensin-converting enzyme inhibitors on mortality and morbidity in patients with heart failure. Collaborative Group on ACE Inhibitor Trials. JAMA. 1995, 273: 1450-1456. 10.1001/jama.1995.03520420066040.
CIBIS-II Investigators and Committees: The cardiac insufficiency bisoprolol study II (CIBIS-II): a randomised trial. Lancet. 1999, 353: 9-13.
Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, et al: The effect of spironolactone on morbidity and mortality in patients with severe heart failure. N Engl J Med. 1999, 341: 709-717. 10.1056/NEJM199909023411001.
Hobbs FDR: Unmet need for diagnosis of heart failure: the view from primary care. Heart. 2002, 88: ii9-ii11.
The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology: ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008. Eur Heart J. 2008, 29: 2388-2442.
Zannad F, McMurray JJV, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, et al: Eplerenone in patients with systolic heart failure and mild symptoms. N Eng J Med. 2010, 364: 11-21.
NICE: Chronic heart failure: national clinical guideline for diagnosis and management in primary and secondary care. Full version of NICE Guideline No. 5. 2003, London: Royal College of Physicians
NICE: Chronic heart failure: management of chronic heart failure in adults in primary and secondary care (partial update). 2010, London: Royal College of Physicians
Hobbs FDR, Jones MI, Allan TF, Wilson S, Tobias R: European survey of primary care physician perceptions on heart failure diagnosis and management (Euro-HF). Eur Heart J. 2000, 21: 1877-1887. 10.1053/euhj.2000.2170.
Hickling JA, Nazareth I, Rogers S: The barriers to effective management of heart failure in general practice. Br J Gen Pract. 2001, 51: 615-618.
Remme WJ, McMurray JJV, Hobbs FDR, Cohen-Solal A, Lopez-Sendon J, Boccanelli A, et al: Awareness and perception of heart failure among European cardiologists, internists, geriatricians, and primary care physicians. Eur Heart J. 2008, 29: 1739-1752. 10.1093/eurheartj/ehn196.
Remme WJ, Swedberg K: Guidelines for the diagnosis and treatment of chronic heart failure. Eur Heart J. 2001, 22: 1527-1560. 10.1053/euhj.2001.2783.
Madhok V, Falk G, Rogers A, Struthers AD, Sullivan FM, Fahey T: The accuracy of symptoms, signs and diagnostic tests in the diagnosis of left ventricular dysfunction in primary care: a diagnostic accuracy systematic review. BMC Fam Pract. 2008, 9: 56-10.1186/1471-2296-9-56.
Badgett RG, Mulrow CD, Otto P, Ramirez G: How well can the chest radiograph diagnose left ventricular dysfunction?. J Gen Intern Med. 1996, 11: 625-634. 10.1007/BF02599031.
Cowie MR, Struthers AD, Wood DA, Coats AJ, Thompson SG, Poole-Wilson PA: Value of natriuretic peptides in assessment of patients with possible new heart failure in primary care. Lancet. 1997, 350: 1349-1353. 10.1016/S0140-6736(97)06031-5.
Cowie MR, Jourdain P, Maisel A, Dahlstrom U, Follath F, Isnard R, et al: Clinical applications of B-type natriuretic peptide (BNP) testing. Eur Heart J. 2003, 24: 1710-1718. 10.1016/S0195-668X(03)00476-7.
Hobbs FDR, Davis RC, Roalfe AK, Hare R, Davies MK: Reliability of N-terminal proBNP assay in diagnosis of left ventricular systolic dysfunction within representative and high risk populations. Heart. 2004, 90: 866-870. 10.1136/hrt.2003.014258.
Hobbs FDR, Davis RC, Roalfe AK, Hare R, Davies MK, Kenkre JE: Reliability of N-terminal pro-brain natriuretic peptide assay in diagnosis of heart failure: cohort study in representative and high risk community populations. BMJ. 2002, 324: 1498-1500. 10.1136/bmj.324.7352.1498.
Wright SP, Doughty RN, Pearl A, Gamble GD, Whalley GA, Walsh HJ, et al: Plasma amino-terminal pro-brain natriuretic peptide and accuracy of heart-failure diagnosis in primary care: a randomized, controlled trial. J Am Coll Cardiol. 2003, 42: 1793-1800. 10.1016/j.jacc.2003.05.011.
Mueller T, Gegenhuber A, Poelz W, Haltmayer M: Diagnostic accuracy of B type natriuretic peptide and amino terminal proBNP in the emergency diagnosis of heart failure. Heart. 2005, 91: 606-612. 10.1136/hrt.2004.037762.
Januzzi J, Camargo CA, Anwaruddin S, Baggish AL, Chen AA, Krauser DG, et al: The N-terminal Pro-BNP investigation of dyspnea in the emergency department (PRIDE) study. Am J Cardiol. 2005, 95: 948-954. 10.1016/j.amjcard.2004.12.032.
Wang CS, FitzGerald JM, Schulzer M, Mak E, Ayas NT: Does this dyspneic patient in the emergency department have congestive heart failure?. JAMA. 2005, 294: 1944-1956. 10.1001/jama.294.15.1944.
Zaphiriou A, Robb S, Murray-Thomas T, Mendez G, Fox K, McDonagh T, et al: The diagnostic accuracy of plasma BNP and NTproBNP in patients referred from primary care with suspected heart failure: results of the UK natriuretic peptide study. Eur J Heart Fail. 2005, 7: 537-541. 10.1016/j.ejheart.2005.01.022.
Fuat A, Murphy JJ, Hungin AP, Curry J, Mehrzad AA, Hetherington A: The diagnostic accuracy and utility of a B-type natriuretic peptide test in a community population of patients with suspected heart failure. Br J Gen Pract. 2006, 56: 327-333.
Battaglia M, Pewsner D, Juni P, Egger M, Bucher HC, Bachmann LM: Accuracy of B-type natriuretic peptide tests to exclude congestive heart failure: systematic review of test accuracy studies. Arch Intern Med. 2006, 166: 1073-1080. 10.1001/archinte.166.10.1073.
McGinn TG, Guyatt GH, Wyer PC, Naylor CD, Stiell IG, Richardson WS, et al: Users’ guides to the medical literature: XXII: how to use articles about clinical decision rules. JAMA. 2000, 284: 79-84. 10.1001/jama.284.1.79.
Stiell IG, Wells GA: Methodological standards for the development of clinical decision rules in emergency medicine. Ann Emerg Med. 1999, 33: 437-447. 10.1016/S0196-0644(99)70309-4.
Mosaterd A, Deckers JW, Hoes AW, Nederpel A, Smeets A, Linker DT, et al: Classification of heart failure in population based research: an assessment of six heart failure scores. Eur J Epidemiol. 1997, 13: 491-502. 10.1023/A:1007383914444.
Baggish AL, Siebert U, Lainchbury JG, Cameron R, Anwaruddin S, Chen A, et al: A validated clinical and biochemical score for the diagnosis of acute heart failure: the ProBNP investigation of dyspnea in the emergency department (PRIDE) acute heart failure score. Am Heart J. 2006, 151: 48-54. 10.1016/j.ahj.2005.02.031.
Fahey T, Jeyaseelan S, McCowan C, Carr E, Goudie B, Pringle S: Diagnosis of left ventricular systolic dysfunction (LVSD): development and validation of a clinical prediction rule in primary care. Fam Pract. 2007, 24: 628-635. 10.1093/fampra/cmm055.
Mant J, Doust J, Roalfe AK, Barton P, Cowie MR, Glasziou P, et al: Systematic review and individual patient data meta-analysis of diagnosis of heart failure, with modelling of implications of different diagnostic strategies in primary care. Health Technol Assess. 2009, 13 (32): 1-232.
Roalfe AK, Mant J, Doust JA, Barton P, Cowie MR, Glasziou P, et al: Development and initial validation of a simple clinical decision tool to predict the presence of heart failure in primary care: the MICE (Male, Infarction, Crepitations, Edema) rule. Eur J Heart Fail. 2012, 14: 1000-1008. 10.1093/eurjhf/hfs089.
Barksfield R: Diagnosing heart failure in primary care. The role of clinical features and BNP: a multicentre UK diagnostic study. BSc dissertation. 2005, Imperial College London
Bossuyt PM, Irwig L, Craig J, Glasziou P: Comparative accuracy: assessing new tests against existing diagnostic pathways. BMJ. 2006, 332: 1089-1092. 10.1136/bmj.332.7549.1089.
Group EQ: EuroQol - a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy. 1990, 16: 199-208.
Ware J, Kosinski M, Keller SD: A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Medical Care. 1996, 34: 220-233. 10.1097/00005650-199603000-00003.
Muller-Nordhorn J, Roll S, Willich SN: Comparison of the short form (SF)-12 health status instrument with the SF-36 in patients with coronary heart disease. Heart. 2004, 90: 523-527. 10.1136/hrt.2003.013995.
Task Force for Diagnosis and Treatment of Acute and Chronic Heart Failure: ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2008. Eur Heart J. 2008, 29: 2388-2442.
Briggs A, Claxton K, Sculpher M: Decision Modelling for Health Economic Evaluation. 2006, Oxford: Oxford University Press
Curtis L: Unit Costs of Health and Social Care. 2007, Kent: Canterbury: Personal Social Services Research Unit, University of Kent at Canterbury
Department of Health: NHS reference costs 2007–08. 2009, London: Department of Health
National Institute for Health and Clinical Excellence: Updated guide to the methods of technology appraisal - June 2008. 2008, London: National Institute for Health and Clinical Excellence
Sutton AJ, Cooper NJ, Goodacre S, Stevenson M: Integration of meta-analysis and economic decision modeling for evaluating diagnostic tests. Medical Decision Making. 2008, 28: 650-667. 10.1177/0272989X08324036.
Wheeldon NM, MacDonald TM, Flucker CJ, McKendrick AD, McDevitt DG, Struthers AD: Echocardiography in chronic heart failure in the community. Quarterly J Med. 1993, 86: 17-20.
Laupacis A, Sekar N, Stiell IG: Clinical prediction rules. A review and suggested modifications of methodological standards. JAMA. 1997, 277: 488-494. 10.1001/jama.1997.03540300056034.
Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, et al: Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Clin Chem. 2003, 49: 1-6. 10.1373/49.1.1.
Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, et al: The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Clin Chem. 2003, 49: 7-18. 10.1373/49.1.7.
Whiting P, Rutjes AWS, Reitsma JB, Glas AS, Bossuyt PMM: Sources of variation and bias in studies of diagnostic accuracy. Arch Intern Med. 2004, 140: 189-202.
Rutjes AWS, Reitsma JB, Di Nisio M, Smidt N, van Rijn JC, Bossuyt PMM: Evidence of bias and variation in diagnostic accuracy studies. Can Med Assoc J. 2006, 174: 469-476. 10.1503/cmaj.050090.