Abstract
BackgroundThe side effects and burden of anticoagulant treatments may contribute to poor compliance and consequently to treatment failure. A specific questionnaire is necessary to assess patients' needs and their perceptions of anticoagulant treatment.MethodsA conceptual model of expectation and satisfaction with anticoagulant treatment was designed by an advisory board and used to guide patient (n = 31) and clinician (n = 17) interviews in French, US English and Dutch. Patients had either atrial fibrillation (AF), deep venous thrombosis (DVT), or pulmonary embolism (PE). Following interviews, three PACT-Q language versions were developed simultaneously and further pilot-tested by 19 patients. Linguistic validations were performed for additional language versions.ResultsInitial concepts were developed to cover three areas of interest: 'Treatment', 'Disease and Complications' and 'Information about disease and anticoagulant treatment'. After clinician and patient interviews, concepts were further refined into four domains and 17 concepts; test versions of the PACT-Q were then created simultaneously in three languages, each containing 27 items grouped into four domains: "Treatment Expectations" (7 items), "Convenience" (11 items), "Burden of Disease and Treatment" (2 items) and "Anticoagulant Treatment Satisfaction" (7 items). No item was deleted or added after pilot testing as patients found the PACT-Q easy to understand and appropriate in length in all languages. The PACT-Q was divided into two parts: the first part to measure the expectations and the second to measure the convenience, burden and treatment satisfaction, for evaluation prior to and after anticoagulant treatment, respectively. Eleven additional language versions were linguistically validated.ConclusionThe PACT-Q has been rigorously developed and linguistically validated. It is available in 14 languages for use with thromboembolic patients, including AF, PE and DVT patients. Its validation and psychometric properties have been tested and are presented in a separate manuscript.
Highlights
The side effects and burden of anticoagulant treatments may contribute to poor compliance and to treatment failure
The mean number of deep venous thrombosis (DVT) and pulmonary embolism (PE) patients treated per year by clinicians was 189 and the mean number of atrial fibrillation (AF) patients treated per year was 129
Concept development Based on the advisory board deliberation, concepts were initially grouped into three areas of interest: 1) Treatment, 2) Disease and Complications and 3) Information about disease and anticoagulant treatment
Summary
The side effects and burden of anticoagulant treatments may contribute to poor compliance and to treatment failure. Thromboembolic events are a major cause of mortality and morbidity in Western societies [1,2,3]. Such events occur when a mechanical mass, termed thrombus, obstructs vascular blood flow locally or detaches and clots to occlude blood flow downstream. Thromboembolic events or recurrences thereof can be effectively reduced by the use of anticoagulants. Three conditions constitute the majority of indications for long-term anticoagulant treatment: atrial fibrillation (AF), where anticoagulants are used to prevent stroke, and deep venous thrombosis (DVT) and pulmonary embolism (PE), where anticoagulants are used to prevent recurrent disease. VKA potencies vary between patients, resulting in unpredictable pharmacodynamic effects and requiring regular monitoring. Significant side effects can occur, which are most prominently bleeding disorders
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