Interpreting treatment effects from clinical trials in the context of real-world risk information: End-stage renal disease prevention in older adults

JAMA Internal Medicine

Volumn 174, Issue 3, 2014, Pages 391-397

  O'Hare, Ann M ^a,b,c   Hotchkiss, John R ^d,e   Kurella Tamura, Manjula ^f,g   Larson, Eric B ^b,c   Hemmelgarn, Brenda R ^h   Batten, Adam ^a   Do, Thy P ^a,i   Covinsky, Kenneth E ^j,k  

^a VA PUGET SOUND HEALTH CARE SYSTEM   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c GROUP HEALTH RESEARCH INSTITUTE   (United States)

^d VETERANS AFFAIRS MEDICAL CENTER   (United States)

^e UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^f VA PALO ALTO HEALTH CARE SYSTEM   (United States)

^g STANFORD UNIVERSITY MEDICAL CENTER   (United States)

^h UNIVERSITY OF CALGARY   (Canada)

ⁱ AMGEN INC   (United States)

^j SAN FRANCISCO VETERANS AFFAIRS MEDICAL CENTER   (United States)

^k UNIVERSITY OF CALIFORNIA   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AMLODIPINE BESYLATE; ANGIOTENSIN RECEPTOR ANTAGONIST; CAPTOPRIL; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; LOSARTAN; PLACEBO; RAMIPRIL;

AGED; ARTICLE; CHRONIC KIDNEY DISEASE; DIABETES MELLITUS; DRUG EFFECT; END STAGE RENAL DISEASE; FEMALE; FOLLOW UP; GERIATRIC DISORDER; GLOMERULUS FILTRATION RATE; HUMAN; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL (TOPIC); RETROSPECTIVE STUDY;

AGED; AGED, 80 AND OVER; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CLINICAL TRIALS AS TOPIC; COMPUTER SIMULATION; FEMALE; GLOMERULAR FILTRATION RATE; HUMANS; KIDNEY FAILURE, CHRONIC; MALE; OUTCOME ASSESSMENT (HEALTH CARE); RETROSPECTIVE STUDIES; RISK FACTORS; UNITED STATES;

EID: 84897713789     PISSN: 21686106     EISSN: None     Source Type: Journal    
DOI: 10.1001/jamainternmed.2013.13328     Document Type: Article

References (34)

1. Van Spall HG, Toren A, Kiss A, Fowler RA. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA. 2007;297(11):1233-1240. (Pubitemid 46465731)
2. Lee PY, Alexander KP, Hammill BG, Pasquali SK, Peterson ED. Representation of elderly persons and women in published randomized trials of acute coronary syndromes. JAMA. 2001;286(6):708-713. (Pubitemid 33010364)
3. Gurwitz JH, Col NF, Avorn J. The exclusion of the elderly and women from clinical trials in acute myocardial infarction. JAMA. 1992;268(11):1417-1422.
4. Heiat A, Gross CP, Krumholz HM. Representation of the elderly, women, and minorities in heart failure clinical trials. Arch Intern Med. 2002;162(15):1682-1688.
5. Tinetti ME, Fried TR, Boyd CM. Designing health care for the most common chronic condition-multimorbidity. JAMA. 2012;307(23):2493-2494.
6. 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: implications for pay for performance. JAMA. 2005;294(6):716-724. (Pubitemid 41159291)
7. Fried TR, Tinetti ME, Iannone L. Primary care clinicians' experiences with treatment decision making for older persons with multiple conditions. Arch Intern Med. 2011;171(1):75-80.
8. Fried TR, McGraw S, Agostini JV, Tinetti ME. Views of older persons with multiple morbidities on competing outcomes and clinical decision-making. J Am Geriatr Soc. 2008;56(10):1839-1844.
9. Tinetti ME, McAvay GJ, Fried TR, et al. Health outcome priorities among competing cardiovascular, fall injury, and medication-related symptom outcomes. J Am Geriatr Soc. 2008;56(8):1409-1416.
10. Tinetti ME, Fried T. The end of the disease era. Am J Med. 2004;116(3):179-185. (Pubitemid 38121675)
11. Gill TM. The central role of prognosis in clinical decision making. JAMA. 2012;307(2):199-200.
12. Walter LC, Covinsky KE. Cancer screening in elderly patients: a framework for individualized decision making. JAMA. 2001;285(21):2750-2756. (Pubitemid 32525372)
13. Reuben DB. Medical care for the final years of life: "When you're 83, it's not going to be 20 years." JAMA. 2009;302(24):2686-2694.
14. Fried TR, Tinetti ME, Iannone L, O'Leary JR, Towle V, Van Ness PH. Health outcome prioritization as a tool for decision making among older persons with multiple chronic conditions. Arch Intern Med. 2011;171(20):1854-1856.
15. O'Hare AM, Kaufman JS, Covinsky KE, Landefeld CS, McFarland LV, Larson EB. Current guidelines for using angiotensin-converting enzyme inhibitors and angiotensin II-receptor antagonists in chronic kidney disease: is the evidence base relevant to older adults? Ann Intern Med. 2009;150(10):717-724.
16. Fink HA, Ishani A, Taylor BC, et al. Screening for, monitoring, and treatment of chronic kidney disease stages 1 to 3: a systematic review for the US Preventive Services Task Force and for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2012;156(8):570-581.
17. Levey AS, Uhlig K. Which antihypertensive agents in chronic kidney disease? Ann Intern Med. 2006;144(3):213-215. (Pubitemid 46780695)
18. Brenner BM, Cooper ME, de Zeeuw D, et al; RENAAL Study Investigators. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med. 2001;345(12):861-869.
19. Lewis EJ, Hunsicker LG, Bain RP, Rohde RD; Collaborative Study Group. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. N Engl J Med. 1993;329(20):1456-1462. (Pubitemid 23335891)
20. Ruggenenti P, Perna A, Gherardi G, et al. Renoprotective properties of ACE-inhibition in non-diabetic nephropathies with non-nephrotic proteinuria. Lancet. 1999;354(9176):359-364. (Pubitemid 29355751)
21. Agodoa LY, Appel L, Bakris GL, et al African American Study of Kidney Disease and Hypertension (AASK) Study Group. Effect of ramipril vs amlodipine on renal outcomes in hypertensive nephrosclerosis: a randomized controlled trial. JAMA. 2001;285(21):2719-2728. (Pubitemid 32525368)
22. Sohn MW, Arnold N, Maynard C, Hynes DM. Accuracy and completeness of mortality data in the Department of Veterans Affairs. Popul Health Metr. April 10, 2006;4:2. doi:10.1186/1478-7954-4-2.
23. Laupacis A, Sackett DL, Roberts RS. An assessment of clinically useful measures of the consequences of treatment. N Engl J Med. 1988;318(26):1728-1733.
24. Nuovo J, Melnikow J, Chang D. Reporting number needed to treat and absolute risk reduction in randomized controlled trials. JAMA. 2002;287(21):2813-2814. (Pubitemid 34591971)
25. Cook RJ, Sackett DL. The number needed to treat: a clinically useful measure of treatment effect. BMJ. 1995;310(6977):452-454.
26. Ridker PM, MacFadyen JG, Fonseca FA, et al; JUPITER Study Group. Number needed to treat with rosuvastatin to prevent first cardiovascular events and death among men and women with low low-density lipoprotein cholesterol and elevated high-sensitivity C-reactive protein: Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER). Circ Cardiovasc Qual Outcomes. 2009;2(6):616-623.
27. Rahman M, Pressel S, Davis BR, et al. Renal outcomes in high-risk hypertensive patients treated with an angiotensin-converting enzyme inhibitor or a calcium channel blocker vs a diuretic: a report from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Arch Intern Med. 2005;165(8):936-946. (Pubitemid 40563242)
28. Upadhyay A, Earley A, Haynes SM, Uhlig K. Systematic review: blood pressure target in chronic kidney disease and proteinuria as an effect modifier. Ann Intern Med. 2011;154(8):541-548.
29. Tangri N, Stevens LA, Griffith J, et al. A predictive model for progression of chronic kidney disease to kidney failure. JAMA. 2011;305(15):1553-1559.
30. Zermansky A. Number needed to harm should be measured for treatments [editorial]. BMJ. 1998;317(7164):1014.
31. Eriksen BO, Ingebretsen OC. The progression of chronic kidney disease: a 10-year population-based study of the effects of gender and age. Kidney Int. 2006;69(2):375-382. (Pubitemid 43323090)
32. Weiss JW, Johnson ES, Petrik A, Smith DH, Yang X, Thorp ML. Systolic blood pressure and mortality among older community-dwelling adults with CKD. Am J Kidney Dis. 2010;56(6):1062-1071.
33. Hall YN, Choi AI, Chertow GM, Bindman AB. Chronic kidney disease in the urban poor. Clin J Am Soc Nephrol. 2010;5(5):828-835.
34. Hemmelgarn BR, Manns BJ, Lloyd A, et al; Alberta Kidney Disease Network. Relation between kidney function, proteinuria, and adverse outcomes. JAMA. 2010;303(5):423-429.