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Items: 1 to 20 of 22

1.

Patient-reported outcomes to support medical product labeling claims: FDA perspective.

Patrick DL, Burke LB, Powers JH, Scott JA, Rock EP, Dawisha S, O'Neill R, Kennedy DL.

Value Health. 2007 Nov-Dec;10 Suppl 2:S125-37. Review.

2.

A re-examination of the metabolic equivalent concept in individuals with coronary heart disease.

Savage PD, Toth MJ, Ades PA.

J Cardiopulm Rehabil Prev. 2007 May-Jun;27(3):143-8.

PMID:
17558194
3.

Identifying heart failure patients at high risk for near-term cardiovascular events with serial health status assessments.

Kosiborod M, Soto GE, Jones PG, Krumholz HM, Weintraub WS, Deedwania P, Spertus JA.

Circulation. 2007 Apr 17;115(15):1975-81. Epub 2007 Apr 9.

4.

Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale.

Whellan DJ, O'Connor CM, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Houston-Miller N, Fleg JL, Schulman KA, Piña IL; HF-ACTION Trial Investigators..

Am Heart J. 2007 Feb;153(2):201-11.

PMID:
17239677
5.

Assessing responsiveness of generic and specific health related quality of life measures in heart failure.

Eurich DT, Johnson JA, Reid KJ, Spertus JA.

Health Qual Life Outcomes. 2006 Nov 24;4:89.

6.

Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.

U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research.; U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research.; U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health..

Health Qual Life Outcomes. 2006 Oct 11;4:79.

7.

Association of functional and health status measures in heart failure.

Myers J, Zaheer N, Quaglietti S, Madhavan R, Froelicher V, Heidenreich P.

J Card Fail. 2006 Aug;12(6):439-45.

PMID:
16911910
8.

Health status identifies heart failure outpatients at risk for hospitalization or death.

Heidenreich PA, Spertus JA, Jones PG, Weintraub WS, Rumsfeld JS, Rathore SS, Peterson ED, Masoudi FA, Krumholz HM, Havranek EP, Conard MW, Williams RE; Cardiovascular Outcomes Research Consortium..

J Am Coll Cardiol. 2006 Feb 21;47(4):752-6. Epub 2006 Jan 26.

9.

Monitoring clinical changes in patients with heart failure: a comparison of methods.

Spertus J, Peterson E, Conard MW, Heidenreich PA, Krumholz HM, Jones P, McCullough PA, Pina I, Tooley J, Weintraub WS, Rumsfeld JS; Cardiovascular Outcomes Research Consortium..

Am Heart J. 2005 Oct;150(4):707-15.

PMID:
16209970
10.

The relationship between B-type natriuretic peptide and health status in patients with heart failure.

Luther SA, McCullough PA, Havranek EP, Rumsfeld JS, Jones PG, Heidenreich PA, Peterson ED, Rathore SS, Krumholz HM, Weintraub WS, Spertus JA, Masoudi FA; Cardiovascular Outcomes Research Consortium..

J Card Fail. 2005 Aug;11(6):414-21.

PMID:
16105631
11.

Comparison of losartan and captopril on heart failure-related outcomes and symptoms from the losartan heart failure survival study (ELITE II).

Konstam MA, Neaton JD, Poole-Wilson PA, Pitt B, Segal R, Sharma D, Dasbach EJ, Carides GW, Dickstein K, Riegger G, Camm AJ, Martinez FA, Bradstreet DC, Ikeda LS, Santoro EP; ELITE II Investigators..

Am Heart J. 2005 Jul;150(1):123-31.

PMID:
16084158
12.

Validation of the EuroQol questionnaire in cardiac rehabilitation.

Schweikert B, Hahmann H, Leidl R.

Heart. 2006 Jan;92(1):62-7. Epub 2005 Mar 29.

13.

The effect of cardiac resynchronization on morbidity and mortality in heart failure.

Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators..

N Engl J Med. 2005 Apr 14;352(15):1539-49. Epub 2005 Mar 7.

14.

Age, functional capacity, and health-related quality of life in patients with heart failure.

Masoudi FA, Rumsfeld JS, Havranek EP, House JA, Peterson ED, Krumholz HM, Spertus JA; Cardiovascular Outcomes Research Consortium..

J Card Fail. 2004 Oct;10(5):368-73.

PMID:
15470645
15.

Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial.

Young JB, Abraham WT, Smith AL, Leon AR, Lieberman R, Wilkoff B, Canby RC, Schroeder JS, Liem LB, Hall S, Wheelan K; Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE ICD) Trial Investigators..

JAMA. 2003 May 28;289(20):2685-94.

PMID:
12771115
16.

Exercise and heart failure: A statement from the American Heart Association Committee on exercise, rehabilitation, and prevention.

Piña IL, Apstein CS, Balady GJ, Belardinelli R, Chaitman BR, Duscha BD, Fletcher BJ, Fleg JL, Myers JN, Sullivan MJ; American Heart Association Committee on exercise, rehabilitation, and prevention..

Circulation. 2003 Mar 4;107(8):1210-25. Review. No abstract available.

17.

Preferences for quality of life or survival expressed by patients with heart failure.

Lewis EF, Johnson PA, Johnson W, Collins C, Griffin L, Stevenson LW.

J Heart Lung Transplant. 2001 Sep;20(9):1016-24.

PMID:
11557198
18.

Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure.

Green CP, Porter CB, Bresnahan DR, Spertus JA.

J Am Coll Cardiol. 2000 Apr;35(5):1245-55.

20.

Prediction of mortality and morbidity with a 6-minute walk test in patients with left ventricular dysfunction. SOLVD Investigators.

Bittner V, Weiner DH, Yusuf S, Rogers WJ, McIntyre KM, Bangdiwala SI, Kronenberg MW, Kostis JB, Kohn RM, Guillotte M, et al.

JAMA. 1993 Oct 13;270(14):1702-7.

PMID:
8411500

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