The Anti-Clot Treatment Scale (ACTS) in clinical trials: cross-cultural validation in venous thromboembolism patients

Abstract

BackgroundThe Anti-Clot Treatment Scale (ACTS) is a 15-item patient-reported instrument of satisfaction with anticoagulant treatment. It includes a 12-item ACTS Burdens scale and a 3-item ACTS Benefits scale. Its role in clinical trials and other settings should be supported by evidence that it is both clinically meaningful and scientifically sound. The aim of the study was to evaluate the measurement performance of the ACTS (Dutch, Italian, French, German and English language versions) in patients with venous thromboembolism based on traditional psychometric methods.MethodsACTS Burdens and Benefits scale data from a large clinical trial (EINSTEIN DVT) involving 1336 people with venous thromboembolism were analysed at both the scale and item level. Five key psychometric properties were examined using traditional psychometric methods: acceptability, scaling assumptions, reliability (including internal consistency reliability, test-retest reproducibility); validity (including known groups and discriminant validity); and responsiveness. These methods of examination underpin the US Food and Drug Administration recommendations for patient-reported outcome instrument evaluation.ResultsOverall, the 12-item ACTS Burdens scale and 3-item ACTS Benefits scale met the psychometric criteria evaluated at both item and scale levels, with the exception of some relatively minor issues in the Dutch language version, which were just below reliability criteria (i.e. alpha = 0.72, test-retest intraclass correlation = 0.79). A consistent finding from item-level evaluations of aggregate endorsement frequencies and skewness suggested that response scales may be improved by reducing the number of response options from five to four.ConclusionsBoth the ACTS Burdens and ACTS Benefits scales consistently satisfied traditional reliability and validity criteria across multiple language datasets, supporting it as a clinically useful patient-reported instrument of satisfaction with anticoagulant treatment in clinical trials.Trial registration numberNCT00440193

Patient-Reported Treatment Satisfaction with Rivaroxaban for Stroke Prevention in Atrial Fibrillation. A French Observational Study, the SAFARI Study

“…The ACTS fulfills these requirements and aims to delineate the burdens and benefits associated with anticoagulation treatment [9]. Both the ACTS Burdens and ACTS Benefits scales consistently satisfied traditional reliability and validity criteria across multiple language populations (including French language), supporting the fact that it is a clinically useful patient-reported instrument of satisfaction with anticoagulant treatment in clinical trials [10]. The SAFARI study has provided robust data on the patient-reported burden and benefit of the switch from VKA to rivaroxaban in this patient population.…”

“…The ACTS was scored in accordance with the developers’ guidelines [10]. The score for each item was obtained by means of a 5-response Likert rating scale (1 –Not at all, 2 –A little, 3 –More or less, 4 –A lot, 5 –Extremely).…”

Associations between illness beliefs, medication beliefs, anticoagulation‐related quality of life, and INR control: Insights from the Switching Study

“…Illness beliefs, medication beliefs, and treatment satisfaction/anticoagulation‐specific quality of life were assessed using a questionnaire pack comprised of the Revised Illness Perceptions Questionnaire (IPQ‐R), the Beliefs about Medicines Questionnaire (BMQ), and the Anti‐Clot Treatment Scale (ACTS), respectively 31, 32, 33. Questions in the IPQ‐R and BMQ are answered on a 5‐point Likert scale “strongly disagree” ascending to “strongly agree” which are scored as 1 and 5, respectively.…”

“…Specific necessity determines the extent the patient recognises the need for VKA therapy, while the specific concern subscale determines how strong their anxieties towards VKAs are 32. The ACTS measures anticoagulation‐specific QoL and treatment satisfaction on two subscales: benefits and burdens of anticoagulation therapy 33, 34. For descriptions of all subscales see Table 1.…”

Impact of Switching From a Vitamin K Antagonist to Rivaroxaban on Satisfaction With Anticoagulation Therapy: The XANTUS‐ACTS Substudy

“…The ACTS is a 17-item, patient-reported measure of satisfaction with anticoagulant treatment. 9 It includes 13 items concerning the burdens of anticoagulant treatment (items 1-12 plus 1 global question about burdens) and 4 items concerning the benefits of anticoagulant treatment (items 14-16 plus 1 global question about benefits). Each of the items is scored on a 5-point Likert scale (1 = not at all; 2 = a little; 3 = moderately; 4 = quite a bit; 5 = extremely).…”