Article Text
Abstract
Background Significant gaps exist between guidelines-recommended therapies for cardiovascular disease prevention and current practice. Fixed-dose combination pills (‘polypills’) potentially improve adherence to therapy. This study is a preference study undertaken in conjunction with a clinical trial of a polypill and seeks to examine the underlying reasons for variations in treatment adherence to recommended therapy.
Methods/design A preference study comprising: (1) Discrete Choice Experiment for patients; and (2) qualitative study of patients and providers. Both components will be conducted on participants in the trial. A joint model combining the observed adherence in the clinical trial (revealed preference) and the Discrete Choice Experiment data (stated preference) will be estimated. Estimates will be made of the marginal effect (importance) of each attribute on overall choice, the extent to which respondents are prepared to trade-off one attribute for another and predicted values of the level of adherence given a fixed set of attributes, and contextual and socio-demographic characteristics. For the qualitative study, a thematic analysis will be used as a means of exploring in depth the preferences and ultimately provide important narratives on the experiences and perspectives of individuals with regard to adherence behaviour.
Ethics and dissemination Primary ethics approval was received from Sydney South West Area Health Service Human Research Ethics Committee (Royal Prince Alfred Hospital zone). In addition to usual scientific forums, the findings will be reported back to the communities involved in the studies through site-specific reports and oral presentations.
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.
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Footnotes
Correction notice The “To cite: …” information and running footer in this article have been updated with the correct volume number (volume 1).
To cite: Jan S, Usherwood T, Brien JA, et al. What determines adherence to treatment in cardiovascular disease prevention? Protocol for a mixed methods preference study. BMJ Open 2011;1:e000372. doi:10.1136/bmjopen-2011-000372
Funding The study is funded by an Australian National Health and Medical Research Council (NHMRC) Project grant (App: 1004623). AC and AP are funded by Senior Research Fellowships from the NHMRC. SJ is funded by an NHMRC Career Development Award. TL is funded by an NHMRC Scholarship and NHMRC Capacity Building Grant (571372).
Competing interests None.
Patient consent Obtained.
Ethics approval Ethics approval was provided by the Sydney South West Area Health Service Human Research Ethics Committee (Royal Prince Alfred Hospital zone).
Contributors SJ, TU, AP, AC and DP conceived the original concept of this study. All authors contributed to the design of the study and are involved in the implementation of the project. SJ wrote the first draft of the protocol. The final manuscript is the product of a series of revisions based on input from all the authors.
Provenance and peer review Not commissioned; internally peer reviewed.