Development and validation of the living with pulmonary hypertension questionnaire in pulmonary arterial hypertension patients

Health and Quality of Life Outcomes

Volumn 11, Issue 1, 2013, Pages

  Bonner, Nicola ^a   Abetz, Linda ^a   Meunier, Juliette ^b   Sikirica, Mirko ^c   Mathai, Stephen C ^d  

^a ADELPHI REAL WORLD   (United Kingdom)

^b Mapi Consultancy   (France)

^c BAYER PHARMA AG   (Germany)

^d JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Face and content validation; Living with pulmonary hypertension questionnaire; Psychometric validation; Pulmonary arterial hypertension

Indexed keywords

ADULT; ARTICLE; CLINICAL ARTICLE; CONCURRENT VALIDITY; CONSTRUCT VALIDITY; CONTENT VALIDITY; CONVERGENT VALIDITY; DISCRIMINANT VALIDITY; FACE VALIDITY; FEMALE; FRANCE; GERMANY; HUMAN; INTERNAL CONSISTENCY; LIVING WITH PULMONARY HYPERTENSION QUESTIONNAIRE; MALE; PHASE 3 CLINICAL TRIAL (TOPIC); PHYSICAL ACTIVITY; PSYCHOMETRY; PULMONARY HYPERTENSION; QUESTIONNAIRE; RELIABILITY; SLEEP; SOCIAL ISOLATION; UNITED STATES; VALIDATION STUDY;

ADULT; AGED; AGED, 80 AND OVER; FEMALE; FRANCE; GERMANY; HUMANS; HYPERTENSION, PULMONARY; MALE; MIDDLE AGED; PSYCHOMETRICS; QUALITY OF LIFE; QUESTIONNAIRES; REPRODUCIBILITY OF RESULTS; UNITED STATES;

EID: 84884864798     PISSN: None     EISSN: 14777525     Source Type: Journal    
DOI: 10.1186/1477-7525-11-161     Document Type: Article

References (50)

1. Kirson NY, Birnbaum HG, Ivanova JI, Waldman T, Joish V, Williamson T. Prevalence of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension in the United States. Curr Med Res Opin 2011, 27(9):1763-1768. 10.1185/03007995.2011.604310, 21793646.
2. Rich S. Right ventricular adaptation and maladaptation in chronic pulmonary arterial hypertension. Cardiol Clin 2012, 30(2):257-269. 10.1016/j.ccl.2012.03.004, 22548816.
3. Rich S, Dantzker DR, Ayres SM, et al. Primary pulmonary hypertension. A national prospective study. Ann Intern Med 1987, 107:216-223. 10.7326/0003-4819-107-2-216, 3605900.
4. Humbert M, Gerry CJ, Khanna D. Early detection and management of pulmonary arterial hypertension. Eur Respir Rev 2012, 21(126):306-312. 10.1183/09059180.00005112, 23204118.
5. Facts About Primary Pulmonary Hypertension from the National Heart, Lung, and Blood Institute (NHLBI) 2008, Available at: URL: http://www.nhlbi.nih.gov/health/dci/Diseases/pah/pah_what.html.
6. Taichman DB, Shin J, Hud L, et al. Health-related quality of life in patients with pulmonary arterial hypertension. Respiratory Research 2005, 6:92-101. 10.1186/1465-9921-6-92, 1208953, 16092961.
7. Doughty N, McKenna SP, Doward LC, Meads DM, Pepke-Zaba J. The Impact of Pulmonary Arterial Hypertension (PAH) on Patients: Results from Qualitative Patient Interviews 2003, Poster Presented at 10th Annual Conference of the International Society for Quality of Life Research (ISOQOL).
8. Shafazand S, Goldstein MK, Doyle RM, Hlatky MA, Gould MK. Health-related quality of life in patients with pulmonary arterial hypertension. Chest 2004, 126:1452-1459. 10.1378/chest.126.5.1452, 15539712.
9. Gilbert C, Brown MC, Cappelleri JC, Carlsson M, McKenna SP. Estimating a minimally important difference in pulmonary arterial hypertension following treatment with sildenafil. Chest 2009, 135(1):137-142. 10.1378/chest.07-0275, 18812447.
10. Chen H, Taichman DB, Doyle RL. Health-related quality of life and patient-reported outcomes in pulmonary arterial hypertension. Proc Am Thorac Soc 2008, 5(5):623-630. 10.1513/pats.200802-020SK, 2645237, 18625755.
11. Chen H, De MT, Kobashigawa EA, Katz PP, Chang VW, Blanc PD. Comparison of cardiac and pulmonary-specific quality-of-life measures in pulmonary arterial hypertension. Eur Respir J 2011, 38(3):608-616. 10.1183/09031936.00161410, 3158810, 21273391.
12. 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. Quality of Life Research 2006, 15:103-115. 10.1007/s11136-005-3513-4, 16411035.
13. U.S.Department of Health and Human Services FDA Center for Drug Evaluation and Research. Guidance For Industry: Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims 2009, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071975.pdf.
14. Barst RJ, McGoon M, McLaughlin V, et al. Berapost therapy for pulmonary arterial hypertension. J Am Coll Cardiol 2003, 41(12):2119-2125. 10.1016/S0735-1097(03)00463-7, 12821234.
15. Simmonneau G, Barst RJ, Galie N, 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(6):800-804. 10.1164/ajrccm.165.6.2106079, 11897647.
16. Snow JL, Kawut SM. Surrogate end points in pulmonary arterial hypertension: assessing the response to therapy. Clin Chest Med 2007, 28:75-viii. 10.1016/j.ccm.2006.11.005, 1868503, 17338929.
17. Barst RJ, Rubin LJ, Long WA, McGoon MD, Rich S, Badesch DB, 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, 334:296-302. 10.1056/NEJM199602013340504, 8532025.
18. Wilkins MR, Paul GA, Strange JW, Tunariu N, Gin-Sing W, Banya WA, et al. Sildenafil versus Endothelin Receptor Antagonist for Pulmonary Hypertension (SERAPH) study. Am J Respir Crit Care Med 2005, 171:1292-1297. 10.1164/rccm.200410-1411OC, 15750042.
19. Galie N, Torbicki A, Barst R, Dartevelle P, Haworth S, Higenbottam T, et al. Guidelines on diagnosis and treatment of pulmonary arterial hypertension. The Task Force on Diagnosis and Treatment of Pulmonary Arterial Hypertension of the European Society of Cardiology. Eur Heart J 2004, 25:2243-2278.
20. 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. 10.1016/j.jacc.2003.10.056, 15063421.
21. Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, 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. 10.1161/CIRCULATIONAHA.106.618397, 16982941.
22. Galie N, Badesch D, Oudiz R, Simonneau G, McGoon MD, Keogh AM, et al. Ambrisentan therapy for pulmonary arterial hypertension. J Am Coll Cardiol 2005, 46:529-535. 10.1016/j.jacc.2005.04.050, 16053970.
23. Lowe B, Grafe K, Ufer C, Kroenke K, Grunig E, Herzog W, et al. Anxiety and depression in patients with pulmonary hypertension. Psychosom Med 2004, 66:831-836. 10.1097/01.psy.0000145593.37594.39, 15564346.
24. Cases of PAH in the U.S 2008, http://en.wikipedia.org/wiki/Pulmonary_hypertension.
25. Mucke HA. Pulmonary arterial hypertension: on the way to a manageable disease. Curr Opin Investig Drugs 2008, 9:957-962.
26. Galie N, Manes A, Negro L, Palazzini M, Bacchi-Reggiani ML, Branzi A. A meta-analysis of randomized controlled trials in pulmonary arterial hypertension. Eur Heart J 2009, 30:394-403. 2642921, 19155250.
27. Rector TS. Overview of the Minnesota Living with Heart Failure® Questionnaire 2005, https://docs.google.com/a/umn.edu/viewer?a=v&pid=sites&srcid=dW1uLmVkdXx0bXN8Z3g6MjQxYWMzOTBkMWYwMjAwZA.
28. 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(2):181-187. 10.1016/j.healun.2006.11.009, 17258153.
29. Lewis GD, Shar R, Shahzad K. Sildenafil improves excercise capacity and quality of life in patients with systolic heart failure and secondary pulmonary hypertension. Circulation 2007, 116(14):1555-1562. 10.1161/CIRCULATIONAHA.107.716373, 17785618.
30. Cenedese E, Speich R, Dorschner L, et al. Measurement of quality of life in pulmonary hypertension and its significance. Eur Respir J 2006, 28(4):808-815. 10.1183/09031936.06.00130405, 16707511.
31. Ulrich S, Speich R, Domenighetti G, et al. Bosentan therapy for chronic thromboembolic pulmonary hypertension. A national open lable study assessing the effect of Bosentan on haemodynamocs, excercise capacity, quality of life, safety and tolerability in patients with chronic thromboembolic pulmonary hypertension (BOCTEPH-Study). Swiss Med Wkly 2007, 137(41-42):573-580.
32. McLaughlin VV, Archer SL, Badesch DB, et al. ACCF/AHA 2009 expert consensus document on pulmonary hypertension a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association developed in collaboration with the American College of Chest Physicians; American Thoracic Society, Inc.; and the Pulmonary Hypertension Association. J Am Coll Cardiol 2009, 53(17):1573-1619. 10.1016/j.jacc.2009.01.004, 19389575.
33. Glaser B, Strauss AL. The Discovery of Grounded Theory: Strategies for Qualitative Research 1967, New Jersey: Aldine de Gruyter.
34. Guest G, Bunce A, Johnson L. How many interviews are enough? An experiment with data saturation and variability. Field Methods 2006, 18(1):59-82. Sage Publications.
35. American Thoracic Society ATS statement: guidelines for the six-minute walk test. American Journal of respiratory and Critical Care Medicine 2002, 166:111-117. http://www.atsjournals.org, American Thoracic Society.
36. Neely G, Ljunggren G, Sylven C, Borg G. Comparison between the Visual Analogue Scale (VAS) and the category ratio scale (CR-10) for the evaluation of leg exertion. Int J Sports Med 1992, 13(2):133-136. 10.1055/s-2007-1021244, 1555902.
37. Borg E. On Percieved Exertion and its Measurement 2007, Sweden: Doctoral Dissertation.
38. Rubin LJ. Diagnosis and management of pulmonary arterial hypertension: ACCP evidence-based clinical practice guidelines. Chest 2004, 126(1 Suppl):7S-10S.
39. Kind P, Brooks R, Rabin R. EQ-5D concepts and methods: a developmental history 2005, The Netherlands: Springer.
40. Wilke C, Pickard A. Test-Retest Reliability of the EQ-5D Visual Analog Scale across Populations and Conditions. Value In Health 2009, 12(3):A30.
41. Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika 1951, 16:297-334.
42. Nunnally JC, Bernstein IH. Psychometric Theory. 3rd ed. ed 1994, New York: McGraw-Hill.
43. Guyatt GH, Deyo RA, Charlson M, Levine MN, Mitchell A. Responsiveness and validity in health status measurements : a clarification. J Clin Epidemiol 1989, 42(5):403-408. 10.1016/0895-4356(89)90128-5, 2659745.
44. Ries AL. Minimally clinically important difference for the UCSD shortness of breath questionnaire, Borg scale, and visual analog scale. COPD 2005, 2(1):105-110. 10.1081/COPD-200050655, 17136970.
45. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 1989, 10(4):407-415. 10.1016/0197-2456(89)90005-6, 2691207.
46. Stockler MR, Osoba D, Goodwin P, Corey P, Tannock IF. Responsiveness to change in health-related quality of life in a randomized clinical trial: a comparison of the Prostate Cancer Specific Quality Of Life Instrument (PROSQOLI) with analogous scales from the EORTC QLQ-C30 and a trial specific module. European organization for research and treatment of cancer. J Clin Epidemiol 1998, 51(2):137-145. 10.1016/S0895-4356(97)00269-2, 9474074.
47. Khadka J, Gothwal VK, McAlinden C, Lamoureux EL, Pesudovs K. The importance of rating scales in measuring patient-reported outcomes. Health Qual Life Outcomes 2012, 10:80. 10.1186/1477-7525-10-80, 3503574, 22794788.
48. Rector TS, Kubo SH, Cohn JN. Patients' self-assessment of the congestive heart failure. Part 2: content, reliability and validity of a new measure, the Minnesota living with heart failure questionnaire. Heart Failure 1987, 114(1 pt 1):198-209.
49. Sloan J, Symonds T, Vargas-Chanes D, Fridley B. Practical guidelines for assessing the clinical significance of health-related quality of life changes within clinical trials. Drug Inf J 2003, 37:23-31.
50. Cohen J. Statistical power analysis for the behavioral sciences 1977, New York: Academic Press.