CC BY 4.0 · TH Open 2018; 02(03): e280-e290
DOI: 10.1055/s-0038-1670631
Original Article
Georg Thieme Verlag KG Stuttgart · New York

Translation, Cultural Adaptation, and Psychometric Properties of the Danish Version of the Anti-Clot Treatment Scale

Willemijn J. Comuth
1   Department of Clinical Biochemistry, Regional Hospital of West Jutland, Herning, Denmark
2   Department of Cardiology, Regional Hospital of West Jutland, Herning, Denmark
3   Faculty of Health, Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark
,
Henrik H. Lauridsen
4   Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark
,
Steen D. Kristensen
3   Faculty of Health, Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark
5   Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark
,
Anna-Marie B. Münster
6   Unit for Thrombosis Research, Department of Regional Health Research, University of Southern Denmark, Esbjerg, Denmark
7   Department of Clinical Biochemistry, Hospital of South West Denmark, Esbjerg, Denmark
› Institutsangaben
Funding This study was supported by The Health Research Fund of the Central Denmark Region (grant number R38-A1516-B118).
Weitere Informationen

Publikationsverlauf

09. April 2018

06. August 2018

Publikationsdatum:
13. September 2018 (online)

Abstract

Background The Anti-Clot Treatment Scale (ACTS) is a 17-item, 2-factor (Burdens and Benefits), patient-reported outcome instrument to evaluate patient satisfaction with oral anticoagulant treatment.

Objectives This study aimed to translate and culturally adapt the English version of the ACTS into Danish and to subsequently validate the Danish version in a population of patients treated with dabigatran etexilate for atrial fibrillation.

Methods The ACTS was translated into Danish and culturally adapted. This prospective phase 4 study included 232 respondents who completed the Danish ACTS after 1 month of treatment with dabigatran etexilate for atrial fibrillation. Psychometric properties were evaluated. For test–retest reliability, the ACTS was measured twice, 2 weeks apart, in a subgroup of 50 stable patients.

Results Generally, a high level of treatment satisfaction was found. Confirmatory factor analysis showed a suboptimal fit for the two-factor model of the original version. Using modification indices of confirmatory factor analysis, a four-factor model had the best fit. Cronbach's α for internal consistency was acceptable at 0.78. There was good test–retest reliability with intraclass correlation at 0.80. Smallest detectable changes (SDCs) for individual patients were 5.89 points for the total ACTS, 5.57 for the reverse Burdens, and 3.34 for Benefits scores. Group SDCs were 0.39, 0.37, and 0.22 respectively. Substantial ceiling effects limit the ability to detect improvement at the high end of the scale.

Conclusion The Danish version of the ACTS has inadequate structural validity. Reliability was acceptable. Ceiling effects challenge detection of improvement of treatment satisfaction in clinical practice in this patient population.

 
  • References

  • 1 Kirchhof P, Benussi S, Kotecha D. , et al; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J 2016; 37 (38) 2893-2962
  • 2 Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol 2014; 6: 213-220
  • 3 Mekaj YH, Mekaj AY, Duci SB, Miftari EI. New oral anticoagulants: their advantages and disadvantages compared with vitamin K antagonists in the prevention and treatment of patients with thromboembolic events. Ther Clin Risk Manag 2015; 11: 967-977
  • 4 Bamber L, Wang MY, Prins MH. , et al. Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of acute symptomatic deep-vein thrombosis. Thromb Haemost 2013; 110 (04) 732-741
  • 5 European Medicines Agency. Summary of opinion (post authorisation). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/000829/WC500105283.pdf . Accessed December 28, 2017
  • 6 European Medicines Agency. Summary of opinion (post authorisation). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/000829/WC500165674.pdf . Accessed December 28, 2017
  • 7 Connolly SJ, Ezekowitz MD, Yusuf S. , et al; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361 (12) 1139-1151
  • 8 Baumhauer JF. Patient-reported outcomes - are they living up to their potential?. N Engl J Med 2017; 377 (01) 6-9
  • 9 Cano SJ, Lamping DL, Bamber L, Smith S. The Anti-Clot Treatment Scale (ACTS) in clinical trials: cross-cultural validation in venous thromboembolism patients. Health Qual Life Outcomes 2012; 10: 120
  • 10 Ageno W, Mantovani LG, Haas S. , et al. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study. Lancet Haematol 2016; 3 (01) e12-e21
  • 11 RIVER registry – RIVaroxaban evaluation in real life setting. Available at: https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/river-registry-rivaroxaban-evaluation-in-real-life-setting/ . Accessed December 28, 2017
  • 12 Coleman CI, Haas S, Turpie AG. , et al; XANTUS Investigators. Impact of switching from a vitamin K antagonist to rivaroxaban on satisfaction with anticoagulation therapy: the XANTUS-ACTS substudy. Clin Cardiol 2016; 39 (10) 565-569
  • 13 Weitz JI, Haas S, Ageno W. , et al. Global anticoagulant registry in the field - venous thromboembolism (GARFIELD-VTE). Rationale and design. Thromb Haemost 2016; 116 (06) 1172-1179
  • 14 ePROVIDE-online support for clinical outcome assessments. Available at: https://eprovide.mapi-trust.org/instruments/anti-clot-treatment-scale . Accessed December 28, 2017
  • 15 Wild D, Grove A, Martin M. , et al; ISPOR Task Force for Translation and Cultural Adaptation. Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) measures: report of the ISPOR task force for translation and cultural adaptation. Value Health 2005; 8 (02) 94-104
  • 16 Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine 2000; 25 (24) 3186-3191
  • 17 Mokkink LB, Terwee CB, Patrick DL. , et al. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res 2010; 19 (04) 539-549
  • 18 Suárez C, Pose A, Montero-Pérez-Barquero M. , et al; en representación del Grupo de Trabajo Comité Científico Estudio ALADIN. [Validation of satisfaction questionnaire ACTS in outpatients with atrial fibrillation treated with oral anticoagulants in Spain. ALADIN Study]. Med Clin (Barc) 2016; 147 (05) 192-198
  • 19 de Vet H, Terwee CB, Mokkink LB, Knol DL. Measurement in Medicine. Cambridge, UK: Cambridge University Press; 2011
  • 20 Lynn MR. Determination and quantification of content validity. Nurs Res 1986; 35 (06) 382-385
  • 21 Hu L, Bentler PM. Cutoff criteria for fit indexes in covariance structure analysis: conventional criteria versus new alternatives. Struct Equ Modeling 1999; 6 (01) 1-55
  • 22 de Vet HC, Terwee CB, Knol DL, Bouter LM. When to use agreement versus reliability measures. J Clin Epidemiol 2006; 59 (10) 1033-1039
  • 23 Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull 1979; 86 (02) 420-428
  • 24 Davidson M, Keating JL. A comparison of five low back disability questionnaires: reliability and responsiveness. Phys Ther 2002; 82 (01) 8-24
  • 25 Roffi M, Patrono C, Collet JP. , et al; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J 2016; 37 (03) 267-315
  • 26 Contreras Muruaga MDM, Vivancos J, Reig G. , et al; ALADIN Study Investigators. Satisfaction, quality of life and perception of patients regarding burdens and benefits of vitamin K antagonists compared with direct oral anticoagulants in patients with nonvalvular atrial fibrillation. J Comp Eff Res 2017; 6 (04) 303-312
  • 27 Prins MH, Lensing AW, Brighton TA. , et al. Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol 2014; 1 (01) e37-e46
  • 28 Fumagalli S, Cardini F, Roberts AT. , et al. Psychological effects of treatment with new oral anticoagulants in elderly patients with atrial fibrillation: a preliminary report. Aging Clin Exp Res 2015; 27 (01) 99-102
  • 29 Jaipaul CK, Rosenthal GE. Are older patients more satisfied with hospital care than younger patients?. J Gen Intern Med 2003; 18 (01) 23-30
  • 30 Al-Windi A. Predictors of satisfaction with health care: a primary healthcare-based study. Qual Prim Care 2005; 13: 67-74
  • 31 Terwee CB, Bot SD, de Boer MR. , et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol 2007; 60 (01) 34-42
  • 32 Stucki G, Boonen A, Tugwell P, Cieza A, Boers M. The world health organisation international classification of functioning, disability and health: a conceptual model and interface for the OMERACT process. J Rheumatol 2007; 34 (03) 600-606
  • 33 Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA 1995; 273 (01) 59-65