What is the methodological and reporting quality of health related quality of life in chronic heart failure clinical trials?

Chang, S; Davidson, PM; Newton, PJ; Krum, H; Salamonson, Y; MacDonald, P

What is the methodological and reporting quality of health related quality of life in chronic heart failure clinical trials?

Chang, S

Davidson, PM

Newton, PJ

Krum, H Salamonson, Y MacDonald, P

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Publication Type:: Journal Article
Citation:: International Journal of Cardiology, 2013, 164 (2), pp. 133 - 140
Issue Date:: 2013-04-05

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Field	Value	Language
dc.contributor.author	Chang, S https://orcid.org/0000-0003-0723-3192	en_US
dc.contributor.author	Davidson, PM https://orcid.org/0000-0003-2050-1534	en_US
dc.contributor.author	Newton, PJ https://orcid.org/0000-0002-5006-2037	en_US
dc.contributor.author	Krum, H	en_US
dc.contributor.author	Salamonson, Y	en_US
dc.contributor.author	MacDonald, P https://orcid.org/0000-0001-5378-2825	en_US
dc.date.available	2012-01-10	en_US
dc.date.issued	2013-04-05	en_US
dc.identifier.citation	International Journal of Cardiology, 2013, 164 (2), pp. 133 - 140	en_US
dc.identifier.issn	0167-5273	en_US
dc.identifier.uri	http://hdl.handle.net/10453/27645
dc.description.abstract	Background: Although the number of clinical trials assessing health related quality of life (HRQoL) in chronic heart failure (CHF) has increased exponentially over the last decade, little is known about the quality of reporting. The purpose of this review was to assess the methodological and reporting rigor of HRQoL in RCTs of pharmacological therapy in CHF. Methods: The electronic data bases, Medline and EMBASE were searched from 1990 to 2009 using the key search terms 'heart failure' combined with 'quality of life', 'pharmacological therapy' and 'randomized controlled trials'. A total of 136 articles were identified and evaluated according to the "Minimum Standard Checklist (MSC) for Evaluating HRQoL Outcomes". Results: According to the MSC criteria, 26 (19.1%) studies were considered 'very limited', 91 (66.9%) were 'limited' and only 19 (14.0%) studies were considered to be of a 'probably robust' in terms of methodological and reporting rigor. In fact, the quality of HRQoL reporting has not improved over time. Conclusion: HRQoL is a critical consideration in CHF management, yet reporting is highly variable. There is a need to develop a standardized method for measuring and reporting HRQoL measures in clinical trials to aid in the interpretation and application of findings. © 2011 Elsevier Ireland Ltd.	en_US
dc.relation.ispartof	International Journal of Cardiology	en_US
dc.relation.isbasedon	10.1016/j.ijcard.2012.01.019	en_US
dc.subject.classification	Cardiovascular System & Hematology	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Chronic Disease	en_US
dc.subject.mesh	Health Status	en_US
dc.subject.mesh	Quality of Life	en_US
dc.subject.mesh	Heart Failure	en_US
dc.subject.mesh	Randomized Controlled Trials as Topic	en_US
dc.title	What is the methodological and reporting quality of health related quality of life in chronic heart failure clinical trials?	en_US
dc.type	Journal Article
utslib.citation.volume	2	en_US
utslib.citation.volume	164	en_US
utslib.for	1102 Cardiorespiratory Medicine and Haematology	en_US
utslib.for	1117 Public Health and Health Services	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/IMPACCT
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Nursing
pubs.organisational-group	/University of Technology Sydney/Strength - CHSP - Health Services and Practice
utslib.copyright.status	closed_access
pubs.issue	2	en_US
pubs.publication-status	Published	en_US
pubs.volume	164	en_US

Abstract:

Background: Although the number of clinical trials assessing health related quality of life (HRQoL) in chronic heart failure (CHF) has increased exponentially over the last decade, little is known about the quality of reporting. The purpose of this review was to assess the methodological and reporting rigor of HRQoL in RCTs of pharmacological therapy in CHF. Methods: The electronic data bases, Medline and EMBASE were searched from 1990 to 2009 using the key search terms 'heart failure' combined with 'quality of life', 'pharmacological therapy' and 'randomized controlled trials'. A total of 136 articles were identified and evaluated according to the "Minimum Standard Checklist (MSC) for Evaluating HRQoL Outcomes". Results: According to the MSC criteria, 26 (19.1%) studies were considered 'very limited', 91 (66.9%) were 'limited' and only 19 (14.0%) studies were considered to be of a 'probably robust' in terms of methodological and reporting rigor. In fact, the quality of HRQoL reporting has not improved over time. Conclusion: HRQoL is a critical consideration in CHF management, yet reporting is highly variable. There is a need to develop a standardized method for measuring and reporting HRQoL measures in clinical trials to aid in the interpretation and application of findings. © 2011 Elsevier Ireland Ltd.

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http://hdl.handle.net/10453/27645