A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation.

Abstract

BACKGROUND: Anticoagulation can reduce quality of life, and different models of anticoagulation management might have different impacts on satisfaction with this component of medical care. Yet, to our knowledge, there are no scales measuring quality of life and satisfaction with anticoagulation that can be generalized across different models of anticoagulation management. We describe the development and preliminary validation of such an instrument - the Duke Anticoagulation Satisfaction Scale (DASS). METHODS: The DASS is a 25-item scale addressing the (a) negative impacts of anticoagulation (limitations, hassles and burdens); and (b) positive impacts of anticoagulation (confidence, reassurance, satisfaction). Each item has 7 possible responses. The DASS was administered to 262 patients currently receiving oral anticoagulation. Scales measuring generic quality of life, satisfaction with medical care, and tendency to provide socially desirable responses were also administered. Statistical analysis included assessment of item variability, internal consistency (Cronbach's alpha), scale structure (factor analysis), and correlations between the DASS and demographic variables, clinical characteristics, and scores on the above scales. A follow-up study of 105 additional patients assessed test-retest reliability. RESULTS: 220 subjects answered all items. Ceiling and floor effects were modest, and 25 of the 27 proposed items grouped into 2 factors (positive impacts, negative impacts, this latter factor being potentially subdivided into limitations versus hassles and burdens). Each factor had a high degree of internal consistency (Cronbach's alpha 0.78-0.91). The limitations and hassles factors consistently correlated with the SF-36 scales measuring generic quality of life, while the positive psychological impact scale correlated with age and time on anticoagulation. The intra-class correlation coefficient for test-retest reliability was 0.80. CONCLUSIONS: The DASS has demonstrated reasonable psychometric properties to date. Further validation is ongoing. To the degree that dissatisfaction with anticoagulation leads to decreased adherence, poorer INR control, and poor clinical outcomes, the DASS has the potential to help identify reasons for dissatisfaction (and positive satisfaction), and thus help to develop interventions to break this cycle. As an instrument designed to be applicable across multiple models of anticoagulation management, the DASS could be crucial in the scientific comparison between those models of care.

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Citation

Published Version (Please cite this version)

10.1186/1477-7525-2-22

Publication Info

Samsa, Greg, David B Matchar, Rowena J Dolor, Ingela Wiklund, Ewa Hedner, Gail Wygant, Ole Hauch, Cheryl Beadle Marple, et al. (2004). A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation. Health Qual Life Outcomes, 2. p. 22. 10.1186/1477-7525-2-22 Retrieved from https://hdl.handle.net/10161/11676.

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Scholars@Duke

Samsa

Gregory P. Samsa

Professor of Biostatistics & Bioinformatics

Greg Samsa is an applied statistician whose primary interests are in study design, instrument development, information synthesis, practice improvement, effective communication of statistical results, and teaching. He is a believer in the power of statistical thinking, as broadly defined.

Dolor

Rowena Joy Dolor

Professor of Medicine

Rowena J. Dolor, MD, MHS did her medical training and internal medicine residency at Duke University Medical Center. She completed the Ambulatory Care/Health Services Research fellowship at the Durham VA Medical Center in 1996 and obtained her Masters in Health Sciences degree in Biometry (renamed MHS in Clinical Research) from the Duke University School of Medicine in 1998. Dr. Dolor was a staff physician in the Ambulatory Care Service at the Durham VA Medical Center and Research Associate at the Center for Health Services Research in Primary Care at the Durham VAMC from 1995-2012.  She is currently an investigator of several federally-funded projects conducted in the community-based setting. Dr. Dolor served as a member of the AHRQ PBRN Resource Center Steering Committee and co-chaired the NAPCRG PBRN conference from 2012-2016.

Since 1996, Dr. Dolor has been the director of the Primary Care Research Consortium (PCRC), a network of primary care practices in the Duke University Health System and outlying communities. The PCRC has participated in over 100 industry- and investigator-initiated studies on hypertension, hyperlipidemia, asthma, otitis, obesity, diabetes, depression, anticoagulation, and vaccines. In 2002, the Duke PCRC received grant funding from the Agency for Healthcare Research and Quality (AHRQ) for Primary Care Practice-based Research Networks (PBRNs). The focus of her research pertains to primary care clinical and outcomes research. She has helped lead a number of comparative effectiveness studies and large, pragmatic trials in the primary care setting.   In addition, Dr. Dolor has led or co-led networks in otolaryngology and integrative medicine.

Dr. Dolor has contributed to the development and methodology of Practice-based Research Networks (PBRNs). She has served as a co-investigator on three online resources to help researchers conduct multi-center research in the primary care practice-based setting – (1) A toolkit for building and sustaining health research partnership with practices and communities, http://www.researchtoolkit.org/index.php (2) Toolkit for Developing and Conducting Multi-site Clinical Trials in Practice Based Research Networks, http://www.dartnet.info/ClinicalTrialsPBRNToolkit.htm ; and (3) PBRN Research Good Practices (PRGP), http://www.napcrg.org/PBRNResearchGoodPractice

From July 2009-June 2012, she served as the Associate Director for the Duke EPC. She worked closely with the Director, Gillian Sanders PhD, in overseeing the day-to-day functioning of EPC projects and supervising EPC personnel.  The Duke EPC was awarded a contract entitled “American Recovery and Reinvestment Act of 2009: Comprehensive EPC Comparative Effectiveness Reviews for Effective Health Care” to serve within a core group of EPCs to focus on a comprehensive approach to comparative effectiveness review (CER) and evidence synthesis. The Duke EPC area of concentration was cardiovascular and pulmonary disorders.

She previously served as the principal investigator for the systematic literature review for the AHA Scientific Statement: Evidence-based guidelines for cardiovascular disease prevention in women published in 2004 and updated in 2007. She was the PI of four CER projects on “Noninvasive Technologies for the Diagnosis of Coronary Artery Disease in Women” and “Treatment Strategies for Women with CAD”, “PAD”, and “UA/NSTEMI” as well as upcoming CER topics on pulmonary arterial hypertension, peripheral artery disease and unstable angina/non-ST elevation myocardial infarction. 

Within the Duke Clinical and Translational Institute (CTSI), Dr. Dolor directs the collaboration with CTSI researchers on community-based PBRN projects. From 2011- 2014, she was co-chair of the CTSA PBRN Collaboration Workgroup, and a member of the Community Engagement Key Function Committee, the CTSA Strategic Goal 4 Combined Networking Group committee, and the CTSA Comparative Effectiveness Research Key Function Committee (CER KFC). Since September 2016, she serves as a Co-chair of the Dissemination, Implementation and Knowledge Transfer Workgroup within the Collaboration Engagement Domain Task Force.

In the fall of 2014, Dr. Dolor joined Vanderbilt part-time as a Consultant/Adjunct Associate Professor of Medicine within the Division of General Internal Medicine. Her role is to assist in the formation of the Meharry-Vanderbilt Clinical Research Network, a PBRN in the mid-Tennessee region.  In addition, she is a co-investigator on the Mid-South Clinical Data Research Network, a PCORnet awardee, to build the partnership with the community practices for comparative effectiveness studies that will utilize the electronic health records/information system infrastructure of the CDRN. 




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