TY - JOUR
T1 - What is the methodological and reporting quality of health related quality of life in chronic heart failure clinical trials?
AU - Chang, Sungwon
AU - Davidson, Patricia M.
AU - Newton, Phillip J.
AU - Krum, Henry
AU - Salamonson, Yenna
AU - MacDonald, Peter
N1 - Funding Information:
Sungwon Chang is supported by an Australian Postgraduate Award , a government scholarship. Dr. Phillip Newton is supported by a Chancellor's Postdoctoral Fellowship from the University of Technology Sydney, Australia .
PY - 2013/4/5
Y1 - 2013/4/5
N2 - 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.
AB - 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.
KW - Chronic heart failure
KW - Clinical decision making
KW - Health related quality of life
KW - Methodological quality
KW - Randomized clinical trials
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U2 - 10.1016/j.ijcard.2012.01.019
DO - 10.1016/j.ijcard.2012.01.019
M3 - Review article
C2 - 22310219
AN - SCOPUS:84875219920
VL - 164
SP - 133
EP - 140
JO - International Journal of Cardiology
JF - International Journal of Cardiology
SN - 0167-5273
IS - 2
ER -