-
1
-
-
2942604605
-
End points and clinical trial designs in pulmonary arterial hypertension: Clinical and regulatory perspectives
-
Hoeper MM, Oudiz RJ, Peacock A, Tapson VF, Haworth SG, Frost AE, Torbicki A. End points and clinical trial designs in pulmonary arterial hypertension: clinical and regulatory perspectives. J Am Coll Cardiol 2004;43:48S-55S.
-
(2004)
J Am Coll Cardiol
, vol.43
-
-
Hoeper, M.M.1
Oudiz, R.J.2
Peacock, A.3
Tapson, V.F.4
Haworth, S.G.5
Frost, A.E.6
Torbicki, A.7
-
2
-
-
0034464640
-
Recommendations on health-related quality of life research to support labeling and promotional claims in the united states
-
Revicki DA, Osoba D, Fairclough D, Barofsky I, Berzon R, Leidy NK, Rothman M. Recommendations on health-related quality of life research to support labeling and promotional claims in the united states. Qual Life Res 2000;9:887-900.
-
(2000)
Qual Life Res
, vol.9
, pp. 887-900
-
-
Revicki, D.A.1
Osoba, D.2
Fairclough, D.3
Barofsky, I.4
Berzon, R.5
Leidy, N.K.6
Rothman, M.7
-
4
-
-
77954032873
-
Guidance for industry patient-reported outcome measures: Use in medical product development to support labeling claims
-
and, accessed 2007 Sep 2, Available from
-
US Food and Drug Administration. Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims. Draft Guidance. 2006 [accessed 2007 Sep 2]. Available from: http://www.fda.gov/cder/guidance/5460dft.pdf
-
(2006)
Draft Guidance
-
-
Food, U.S.1
-
6
-
-
0020410785
-
Psychophysical bases of perceived exertion
-
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc 1982;14:377-381.
-
(1982)
Med Sci Sports Exerc
, vol.14
, pp. 377-381
-
-
Borg, G.A.1
-
7
-
-
0028893864
-
Linking clinical variables with health-related quality of life: A conceptual model of patient outcomes
-
Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life: a conceptual model of patient outcomes. JAMA 1995;273:59-65.
-
(1995)
JAMA
, vol.273
, pp. 59-65
-
-
Wilson, I.B.1
Cleary, P.D.2
-
8
-
-
26444566861
-
Health-related quality of life in patients with pulmonary arterial hypertension
-
Taichman DB, Shin J, Hud L, Archer-Chicko C, Kaplan S, Sager JS, Gallop R, Christie J, Hansen-Flaschen J, Palevsky H. Health-related quality of life in patients with pulmonary arterial hypertension. Respir Res 2005;6:92.
-
(2005)
Respir Res
, vol.6
, pp. 92
-
-
Taichman, D.B.1
Shin, J.2
Hud, L.3
Archer-Chicko, C.4
Kaplan, S.5
Sager, J.S.6
Gallop, R.7
Christie, J.8
Hansen-Flaschen, J.9
Palevsky, H.10
-
9
-
-
33847380183
-
Measurement of quality of life in pulmonary hypertension and its significance
-
Cenedese E, Speich R, Dorschner L, Ulrich S, Maggiorini M, Jenni R, Fischler M. Measurement of quality of life in pulmonary hypertension and its significance. Eur Respir J 2006;28:808-815.
-
(2006)
Eur Respir J
, vol.28
, pp. 808-815
-
-
Cenedese, E.1
Speich, R.2
Dorschner, L.3
Ulrich, S.4
Maggiorini, M.5
Jenni, R.6
Fischler, M.7
-
10
-
-
33749856309
-
Comparison and validation of three measures of quality of life in patients with pulmonary hypertension
-
Chua R, Keogh AM, Byth K, O'Loughlin A. Comparison and validation of three measures of quality of life in patients with pulmonary hypertension. Intern Med J 2006;36:705-710.
-
(2006)
Intern Med J
, vol.36
, pp. 705-710
-
-
Chua, R.1
Keogh, A.M.2
Byth, K.3
O'Loughlin, A.4
-
11
-
-
0023970936
-
Evaluation of clinical methods for rating dyspnea
-
Mahler DA, Wells CK. Evaluation of clinical methods for rating dyspnea. Chest 1988;93:580-586.
-
(1988)
Chest
, vol.93
, pp. 580-586
-
-
Mahler, D.A.1
Wells, C.K.2
-
12
-
-
0030798771
-
Patient-assessed health outcomes in chronic lung disease: What are they, how do they help us, and where do we go from here?
-
Curtis JR, Martin DP, Martin TR. Patient-assessed health outcomes in chronic lung disease: what are they, how do they help us, and where do we go from here? Am J Respir Crit Care Med 1997;156:1032-1039.
-
(1997)
Am J Respir Crit Care Med
, vol.156
, pp. 1032-1039
-
-
Curtis, J.R.1
Martin, D.P.2
Martin, T.R.3
-
13
-
-
33646384402
-
Health status: What does it mean for payers and patients?
-
Jones PW. Health status: what does it mean for payers and patients? Proc Am Thorac Soc 2006;3:222-226.
-
(2006)
Proc Am Thorac Soc
, vol.3
, pp. 222-226
-
-
Jones, P.W.1
-
14
-
-
0001862129
-
Measurement in clinical trials: Choosing the right approach
-
Spilker B, editor, 2nd edition. Philadelphia: Lippincott-Raven Publishers;
-
Guyatt GH, Jaeschke R, Feeney DH, Patrick DL. Measurement in clinical trials: choosing the right approach. In: Spilker B, editor. Quality of life and pharmacoeconomics in clinical trials, 2nd edition. Philadelphia: Lippincott-Raven Publishers; 1996. pp. 41-48.
-
(1996)
Quality of life and pharmacoeconomics in clinical trials
, pp. 41-48
-
-
Guyatt, G.H.1
Jaeschke, R.2
Feeney, D.H.3
Patrick, D.L.4
-
15
-
-
0001889066
-
How to develop and validate a new health-related quality of life instrument
-
Spilker B, editor, 2nd edition. Philadelphia: Lippincott-Raven Publishers;
-
Juniper EF, Guyatt GH, Jaeschke R. How to develop and validate a new health-related quality of life instrument. In: Spilker B, editor. Quality of life and pharmacoeconomics in clinical trials, 2nd edition. Philadelphia: Lippincott-Raven Publishers; 1996. pp. 49-56.
-
(1996)
Quality of life and pharmacoeconomics in clinical trials
, pp. 49-56
-
-
Juniper, E.F.1
Guyatt, G.H.2
Jaeschke, R.3
-
16
-
-
0026877917
-
The mos 36-item short-form health survey (sf-36). I. Conceptual framework and item selection
-
Ware JE Jr, Sherbourne CD. The mos 36-item short-form health survey (sf-36). I. Conceptual framework and item selection. Med Care 1992;30:473-483.
-
(1992)
Med Care
, vol.30
, pp. 473-483
-
-
Ware Jr, J.E.1
Sherbourne, C.D.2
-
17
-
-
0019277855
-
The development of a subjective health indicator
-
Hunt SM, McEwen J. The development of a subjective health indicator. Sociol Health Illn 1980;2:231-246.
-
(1980)
Sociol Health Illn
, vol.2
, pp. 231-246
-
-
Hunt, S.M.1
McEwen, J.2
-
18
-
-
0025688231
-
Euroqol-a new facility for the measurement of health-related quality of life
-
The euroqol group
-
The euroqol group. Euroqol-a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199-208.
-
(1990)
Health Policy
, vol.16
, pp. 199-208
-
-
-
19
-
-
0032770617
-
The assessment of quality of life (aqol) instrument: A psychometric measure of health-related quality of life
-
Hawthorne G, Richardson J, Osborne R. The assessment of quality of life (aqol) instrument: a psychometric measure of health-related quality of life. Qual Life Res 1999;8:209-224.
-
(1999)
Qual Life Res
, vol.8
, pp. 209-224
-
-
Hawthorne, G.1
Richardson, J.2
Osborne, R.3
-
20
-
-
16344378766
-
Measuring and reporting quality of life outcomes in clinical trials in cystic fibrosis: A critical review
-
Abbott J, Hart A. Measuring and reporting quality of life outcomes in clinical trials in cystic fibrosis: a critical review. Health Qual Life Outcomes 2005;3:19.
-
(2005)
Health Qual Life Outcomes
, vol.3
, pp. 19
-
-
Abbott, J.1
Hart, A.2
-
21
-
-
22044432630
-
Health-related quality of life in patients with idiopathic pulmonary fibrosis: A systematic review
-
Swigris JJ, Kuschner WG, Jacobs SS, Wilson SR, Gould MK. Health-related quality of life in patients with idiopathic pulmonary fibrosis: a systematic review. Thorax 2005;60:588-594.
-
(2005)
Thorax
, vol.60
, pp. 588-594
-
-
Swigris, J.J.1
Kuschner, W.G.2
Jacobs, S.S.3
Wilson, S.R.4
Gould, M.K.5
-
22
-
-
33847656998
-
Quality of life and health status in sarcoidosis: A review
-
De Vries J, Drent M. Quality of life and health status in sarcoidosis: a review. Semin Respir Crit Care Med 2007;28:121-127.
-
(2007)
Semin Respir Crit Care Med
, vol.28
, pp. 121-127
-
-
De Vries, J.1
Drent, M.2
-
23
-
-
8744269595
-
Health-related quality of life in patients with pulmonary arterial hypertension
-
Shafazand S, Goldstein MK, Doyle RL, Hlatky MA, Gould MK. Health-related quality of life in patients with pulmonary arterial hypertension. Chest 2004;126:1452-1459.
-
(2004)
Chest
, vol.126
, pp. 1452-1459
-
-
Shafazand, S.1
Goldstein, M.K.2
Doyle, R.L.3
Hlatky, M.A.4
Gould, M.K.5
-
25
-
-
50549089845
-
Evaluation of disease-specific health-related quality of life in patients with pulmonary arterial hypertension
-
In Press
-
Zlupko M, Harhay MO, Gallop R, Shin J, Archer-Chicko C, Patel R, Palevsky HI, Taichman DB. Evaluation of disease-specific health-related quality of life in patients with pulmonary arterial hypertension. Respir Med (In Press).
-
Respir Med
-
-
Zlupko, M.1
Harhay, M.O.2
Gallop, R.3
Shin, J.4
Archer-Chicko, C.5
Patel, R.6
Palevsky, H.I.7
Taichman, D.B.8
-
26
-
-
33846372988
-
Quality of life in pulmonary arterial hypertension: Improvement and maintenance with bosentan
-
Keogh AM, McNeil KD, Wlodarczyk J, Gabbay E, Williams TJ. Quality of life in pulmonary arterial hypertension: improvement and maintenance with bosentan. J Heart Lung Transplant 2007;26:181-187.
-
(2007)
J Heart Lung Transplant
, vol.26
, pp. 181-187
-
-
Keogh, A.M.1
McNeil, K.D.2
Wlodarczyk, J.3
Gabbay, E.4
Williams, T.J.5
-
27
-
-
17844396242
-
Population norms and meaningful differences for the assessment of quality of life (aqol) measure
-
Hawthorne G, Osborne R. Population norms and meaningful differences for the assessment of quality of life (aqol) measure. Aust N Z J Public Health 2005;29:136-142.
-
(2005)
Aust N Z J Public Health
, vol.29
, pp. 136-142
-
-
Hawthorne, G.1
Osborne, R.2
-
28
-
-
30744478224
-
The cambridge pulmonary hypertension outcome review (camphor): A measure of health-related quality of life and quality of life for patients with pulmonary hypertension
-
McKenna SP, Doughty N, Meads DM, Doward LC, Pepke-Zaba J. The cambridge pulmonary hypertension outcome review (camphor): a measure of health-related quality of life and quality of life for patients with pulmonary hypertension. Qual Life Res 2006;15:103-115.
-
(2006)
Qual Life Res
, vol.15
, pp. 103-115
-
-
McKenna, S.P.1
Doughty, N.2
Meads, D.M.3
Doward, L.C.4
Pepke-Zaba, J.5
-
29
-
-
6344282674
-
The needs-based approach to quality of life assessment
-
McKenna SP, Doward LC. The needs-based approach to quality of life assessment. Value Health 2004;7:S1-S3.
-
(2004)
Value Health
, vol.7
-
-
McKenna, S.P.1
Doward, L.C.2
-
30
-
-
37549001338
-
United states validation of the cambridge pulmonary hypertension outcome review (camphor)
-
Gomberg-Maitland M, Thenappan T, Rizvi K, Chandra S, Meads DM, McKenna SP. United states validation of the cambridge pulmonary hypertension outcome review (camphor). J Heart Lung Transplant 2008;27:124-130.
-
(2008)
J Heart Lung Transplant
, vol.27
, pp. 124-130
-
-
Gomberg-Maitland, M.1
Thenappan, T.2
Rizvi, K.3
Chandra, S.4
Meads, D.M.5
McKenna, S.P.6
-
31
-
-
0037951757
-
On assessing responsiveness of health-related quality of life instruments: Guidelines for instrument evaluation
-
Terwee CB, Dekker FW, Wiersinga WM, Prummel MF, Bossuyt PM. On assessing responsiveness of health-related quality of life instruments: guidelines for instrument evaluation. Qual Life Res 2003;12:349-362.
-
(2003)
Qual Life Res
, vol.12
, pp. 349-362
-
-
Terwee, C.B.1
Dekker, F.W.2
Wiersinga, W.M.3
Prummel, M.F.4
Bossuyt, P.M.5
-
32
-
-
14844284557
-
Living with pulmonary artery hypertension: Patients' experiences
-
Flattery MP, Pinson JM, Savage L, Salyer J. Living with pulmonary artery hypertension: patients' experiences. Heart Lung 2005;34:99-107.
-
(2005)
Heart Lung
, vol.34
, pp. 99-107
-
-
Flattery, M.P.1
Pinson, J.M.2
Savage, L.3
Salyer, J.4
-
33
-
-
33747061064
-
Cognitive, emotional, and quality of life outcomes in patients with pulmonary arterial hypertension
-
White J, Hopkins RO, Glissmeyer EW, Kitterman N, Elliott CG. Cognitive, emotional, and quality of life outcomes in patients with pulmonary arterial hypertension. Respir Res 2006;7:55.
-
(2006)
Respir Res
, vol.7
, pp. 55
-
-
White, J.1
Hopkins, R.O.2
Glissmeyer, E.W.3
Kitterman, N.4
Elliott, C.G.5
-
34
-
-
0027200353
-
Interpretation of quality of life changes
-
Lydick E, Epstein RS. Interpretation of quality of life changes. Qual Life Res 1993;2:221-226.
-
(1993)
Qual Life Res
, vol.2
, pp. 221-226
-
-
Lydick, E.1
Epstein, R.S.2
-
35
-
-
47749104761
-
Interpreting the results of quality-of-life measures in clinical trials: The clinician's perspective
-
Lenderking WR, Revicki DA, editors, McLean, VA: Degnon Associates, Inc
-
Schunemann HJ, Guyatt GH. Interpreting the results of quality-of-life measures in clinical trials: the clinician's perspective. In: Lenderking WR, Revicki DA, editors. Advancing health outcomes research methods and clinical applications. McLean, VA: Degnon Associates, Inc., 2005. pp. 201-212.
-
(2005)
Advancing health outcomes research methods and clinical applications
, pp. 201-212
-
-
Schunemann, H.J.1
Guyatt, G.H.2
-
36
-
-
47749098742
-
Expert panel report 3 full
-
National asthma education and prevention program, cited 2007 Sep 2, Available from
-
National asthma education and prevention program. Expert panel report 3 full report 2007. Guidelines for the diagnosis and management of asthma: measures of asthma assessment and monitoring. National heart, lung, and blood institute. 2007 [cited 2007 Sep 2]. Available from: http://www.nhlbi.nih.gov/ guidelines/asthma/04_sec3_comp.pdf.
-
(2007)
Guidelines for the diagnosis and management of asthma: Measures of asthma assessment and monitoring
-
-
-
37
-
-
0030031888
-
A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension: The primary pulmonary hypertension study group
-
Barst RJ, Rubin LJ, Long WA, McGoon MD, Rich S, Badesch DB, Groves BM, Tapson VF, Bourge RC, Brundage BH, et al. A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension: the primary pulmonary hypertension study group. N Engl J Med 1996;3034:296-302.
-
(1996)
N Engl J Med
, vol.3034
, pp. 296-302
-
-
Barst, R.J.1
Rubin, L.J.2
Long, W.A.3
McGoon, M.D.4
Rich, S.5
Badesch, D.B.6
Groves, B.M.7
Tapson, V.F.8
Bourge, R.C.9
Brundage, B.H.10
-
38
-
-
0036682273
-
Inhaled iloprost for severe pulmonary hypertension
-
Olschewski H, Simonneau G, Galie N, Higenbottam T, Naeije R, Rubin LJ, Nikkho S, Speich R, Hoeper MM, Behr J, et al. Inhaled iloprost for severe pulmonary hypertension. N Engl J Med 2002;347:322-329.
-
(2002)
N Engl J Med
, vol.347
, pp. 322-329
-
-
Olschewski, H.1
Simonneau, G.2
Galie, N.3
Higenbottam, T.4
Naeije, R.5
Rubin, L.J.6
Nikkho, S.7
Speich, R.8
Hoeper, M.M.9
Behr, J.10
-
39
-
-
0037086133
-
Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: A double-blind, randomized, placebo-controlled trial
-
Simonneau G, Barst RJ, Galie N, Naeije R, Rich S, Bourge RC, Keogh A, Oudiz R, Frost A, Blackburn SD, et al. Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: a double-blind, randomized, placebo-controlled trial. Am J Respir Crit Care Med 2002;165:800-804.
-
(2002)
Am J Respir Crit Care Med
, vol.165
, pp. 800-804
-
-
Simonneau, G.1
Barst, R.J.2
Galie, N.3
Naeije, R.4
Rich, S.5
Bourge, R.C.6
Keogh, A.7
Oudiz, R.8
Frost, A.9
Blackburn, S.D.10
-
40
-
-
0038037766
-
Beraprost therapy for pulmonary arterial hypertension
-
Barst RJ, McGoon M, McLaughlin V, Tapson V, Rich S, Rubin L, Wasserman K, Oudiz R, Shapiro S, Robbins IM, et al. Beraprost therapy for pulmonary arterial hypertension. J Am Coll Cardiol 2003;41:2119-2125.
-
(2003)
J Am Coll Cardiol
, vol.41
, pp. 2119-2125
-
-
Barst, R.J.1
McGoon, M.2
McLaughlin, V.3
Tapson, V.4
Rich, S.5
Rubin, L.6
Wasserman, K.7
Oudiz, R.8
Shapiro, S.9
Robbins, I.M.10
-
41
-
-
1842530387
-
Clinical efficacy of sildenafil in primary pulmonary hypertension: A randomized, placebo-controlled, double-blind, crossover study
-
Sastry BK, Narasimhan C, Reddy NK, Raju BS. Clinical efficacy of sildenafil in primary pulmonary hypertension: a randomized, placebo-controlled, double-blind, crossover study. J Am Coll Cardiol 2004;43:1149-1153.
-
(2004)
J Am Coll Cardiol
, vol.43
, pp. 1149-1153
-
-
Sastry, B.K.1
Narasimhan, C.2
Reddy, N.K.3
Raju, B.S.4
-
42
-
-
10744230817
-
Sitaxsentan therapy for pulmonary arterial hypertension
-
Barst RJ, Langleben D, Frost A, Horn EM, Oudiz R, Shapiro S, McLaughlin V, Hill N, Tapson VF, Robbins IM, et al. Sitaxsentan therapy for pulmonary arterial hypertension. Am J Respir Crit Care Med 2004;169:441-447.
-
(2004)
Am J Respir Crit Care Med
, vol.169
, pp. 441-447
-
-
Barst, R.J.1
Langleben, D.2
Frost, A.3
Horn, E.M.4
Oudiz, R.5
Shapiro, S.6
McLaughlin, V.7
Hill, N.8
Tapson, V.F.9
Robbins, I.M.10
-
43
-
-
4143121167
-
-
Oudiz RJ, Schilz RJ, Barst RJ, Galie N, Rich S, Rubin LJ, Simonneau G. Treprostinil, a prostacyclin analogue, in pulmonary arterial hypertension associated with connective tissue disease. Chest 2004;126:420-427.
-
Oudiz RJ, Schilz RJ, Barst RJ, Galie N, Rich S, Rubin LJ, Simonneau G. Treprostinil, a prostacyclin analogue, in pulmonary arterial hypertension associated with connective tissue disease. Chest 2004;126:420-427.
-
-
-
-
44
-
-
22844436819
-
Ambrisentan therapy for pulmonary arterial hypertension
-
Galie N, Badesch D, Oudiz R, Simonneau G, McGoon MD, Keogh AM, Frost AE, Zwicke D, Naeije R, Shapiro S, et al. Ambrisentan therapy for pulmonary arterial hypertension. J Am Coll Cardiol 2005;46:529-535.
-
(2005)
J Am Coll Cardiol
, vol.46
, pp. 529-535
-
-
Galie, N.1
Badesch, D.2
Oudiz, R.3
Simonneau, G.4
McGoon, M.D.5
Keogh, A.M.6
Frost, A.E.7
Zwicke, D.8
Naeije, R.9
Shapiro, S.10
-
45
-
-
21144437393
-
Sildenafil versus endothelin receptor antagonist for pulmonary hypertension (SERAPH) study
-
Wilkins MR, Paul GA, Strange JW, Tunariu N, Gin-Sing W, Banya WA, Westwood MA, Stefanidis A, Ng LL, Pennell DJ, et al. Sildenafil versus endothelin receptor antagonist for pulmonary hypertension (SERAPH) study. Am J Respir Crit Care Med 2005;171:1292-1297.
-
(2005)
Am J Respir Crit Care Med
, vol.171
, pp. 1292-1297
-
-
Wilkins, M.R.1
Paul, G.A.2
Strange, J.W.3
Tunariu, N.4
Gin-Sing, W.5
Banya, W.A.6
Westwood, M.A.7
Stefanidis, A.8
Ng, L.L.9
Pennell, D.J.10
-
46
-
-
33749525364
-
Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension
-
Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, Meyer FJ, Karger G, Buss J, Juenger J, et al. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation 2006;114:1482-1489.
-
(2006)
Circulation
, vol.114
, pp. 1482-1489
-
-
Mereles, D.1
Ehlken, N.2
Kreuscher, S.3
Ghofrani, S.4
Hoeper, M.M.5
Halank, M.6
Meyer, F.J.7
Karger, G.8
Buss, J.9
Juenger, J.10
-
47
-
-
34948865560
-
Selective endothelin a receptor antagonism with sitaxsentan for pulmonary arterial hypertension associated with connective tissue disease
-
Girgis RE, Frost AE, Hill NS, Horn EM, Langleben D, McLaughlin VV, Oudiz RJ, Robbins IM, Seibold JR, Shapiro S, et al. Selective endothelin a receptor antagonism with sitaxsentan for pulmonary arterial hypertension associated with connective tissue disease. Ann Rheum Dis 2007;66:1467-1472.
-
(2007)
Ann Rheum Dis
, vol.66
, pp. 1467-1472
-
-
Girgis, R.E.1
Frost, A.E.2
Hill, N.S.3
Horn, E.M.4
Langleben, D.5
McLaughlin, V.V.6
Oudiz, R.J.7
Robbins, I.M.8
Seibold, J.R.9
Shapiro, S.10
|