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Development and validation of a new questionnaire measuring treatment satisfaction in patients with non-valvular atrial fibrillation: SAFUCA®

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Abstract

Objective

To develop a new questionnaire with good psychometric properties to measure satisfaction with medical care in patients with non-valvular atrial fibrillation.

Method

The initial instrument was composed of 37 items, arranged in 6 dimensions: efficacy, ease and convenience, impact on daily activities, satisfaction with medical care, undesired effects of medication, and overall satisfaction. Items and dimensions were extracted from reviewing existing instruments, 3 focus groups with chronic patients, and a panel of 8 experts. Additionally, 3 visual analog scales measuring quality of life, effectiveness, and overall satisfaction were administered. A convenience sample of 119 patients was used for item reduction. Classic psychometric theory and item analysis techniques were used (exploratory factor and confirmatory factor analysis, test–retest, and correlation with visual scales). A validation sample of 230 patients was used to assess convergent validity, and an additional 220 patients sample was used to discriminate between treatment and compliance groups.

Results

The questionnaire was reduced in length to 25 items, but the impact dimension had split in treatment inconvenience and treatment control. Overall reliability was high (α = 0.861) with acceptable dimensional reliabilities (α = 0.764–0.908). Individual dimensions correlated to varying degrees. Test–retest correlations were high (r = 0.784–0.965), and correlations with visual and already validated scales were substantial. Differences were detected between antivitamin K and new-oral-anticoagulant treatments in several dimensions (p < 0.05). Treatment satisfaction was related with compliance.

Conclusion

This new 25-item questionnaire has good psychometric properties for measuring satisfaction with medical care in patients with this condition. It is capable of detecting differences between different treatments.

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References

  1. Wolf, P. A., Abbott, R. D., & Kennel, W. B. (1991). Atrial fibrillation as an independent risk factor for stroke: The Framinghan study. Stroke, 22, 983–988.

    Article  CAS  PubMed  Google Scholar 

  2. Albers, G. W., Dalen, J. E., Laupacis, A., Manning, W. J., Petersen, P., & Singer, D. E. (2001). Antitrombotic therapy in atrial fibrillation. Chest, 119(Suppl 1), 194S–206S.

    Article  CAS  PubMed  Google Scholar 

  3. Holbrook, A. M., Pereira, J. A., Labiris, R., McDonald, H., Douketis, J. D., Crowther, M., et al. (2005). Systematic overview of warfarin and its drug and food interaction. Archives of Internal Medicine, 165, 1095–1106.

    Article  CAS  PubMed  Google Scholar 

  4. Katsnelson, M., Sacco, R. L., & Moscucci, M. (2012). Progress for stroke prevention with atrial fibrillation: Emergence of alternative OACs. Stroke, 43, 1179–1185.

    Article  PubMed  Google Scholar 

  5. Rummel, R. J. (1970). Applied factor analysis. Evanston: Northwestern University Press.

    Google Scholar 

  6. Boomsma, A. (1985). Nonconvergence, improper solutions, and starting values in LISREL maximum likelihood estimation. Psychometrika, 52, 345–370.

    Google Scholar 

  7. Marsh, H. W., & Hau, K.-T. (1999). Confirmatory factor analysis: Strategies for small sample sizes. In R. H. Hoyle (Ed.), Statistical strategies for small sample size (pp. 251–306). Thousand Oaks: Sage.

    Google Scholar 

  8. Wang, J., & Wang, X. (2012). Structural equation modeling. Applications using Mplus. Hoboken: Wiley.

    Book  Google Scholar 

  9. Anderson, J. C., & Gerbing, D. W. (1998). Structural equation modeling in practice: A review and recommended two step approach. Psychological Bulletin, 103, 411–423.

    Article  Google Scholar 

  10. Ding, L., Velicer, W. F., & Harlow, L. L. (1995). Effects of estimation methods, number of indicators per factor, and improper solutions on structural equation modeling fit indices. Structural Equation Modeling, 2, 119–144.

    Article  Google Scholar 

  11. Tabachnick, B. G., & Fidell, L. S. (2001). Using multivariate statistics (4th ed.). Boston: Allyn & Bacon.

    Google Scholar 

  12. Hoogland, J. J., & Boomsma, A. (1998). Robustness studies in covariance structure modeling: An overview and a meta-analysis. Sociological Methods and Research, 26, 329–367.

    Article  Google Scholar 

  13. Kline, R. B. (2005). Principles and practice of structural equation modeling (2nd ed.). New York: Guilford.

    Google Scholar 

  14. Ruiz, M. A., Pardo, A., Rejas, J., Soto, J., Villasante, F., & Aranguren, J. L. (2008). Development and validation of the “Treatment Satisfaction with Medicines Questionnaire” (SATMED-Q)©. Value Health, 11(5), 913–926.

    Article  PubMed  Google Scholar 

  15. Atkinson, M. J., Sinha, A., Hass, S. L., Colman, S. S., Kumar, R. N., & Rowland, C. R. (2004). Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medications (TSQM) using a National Panel Study of Chronic Disease. Health Qual Life Outcomes, 2, 12–25.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Morisky, D. E., Green, L. W., & Levine, D. M. (1986). Concurrent and predictive validity of a self-reported measure of medication adherence. Medical Care, 24, 67–74.

    Article  CAS  PubMed  Google Scholar 

  17. Samsa, G., Matchar, D. B., Dolor, R. J., Wiklund, I., Hedner, E., Wygant, G., et al. (2004). A new instrument for measuring anticoagulation-related quality of life: Development and preliminary validation. Health Qual Life Outcomes, 2, 22.

    Article  PubMed  PubMed Central  Google Scholar 

  18. Cano, S. J., Lamping, D. L., Bamber, L., & Smith, S. (2012). The Anti-Clot Treatment Scale (ACTS) in clinical trials: Cross-cultural validation in venous thromboembolism patients. Health Qual Life Outcomes, 10, 120.

    Article  PubMed  PubMed Central  Google Scholar 

  19. Prins, M. H., Marrel, A., Carita, P., Anderson, D., Bousser, M. G., Crijns, H., et al. (2009). Multinational development of a questionnaire assessing patient satisfaction with anticoagulant treatment: The ‘Perception of Anticoagulant Treatment Questionnaire’ (PACT-Q©). Health Qual Life Outcomes, 7, 9.

    Article  PubMed  PubMed Central  Google Scholar 

  20. Sánchez, R., Yanes, M., Cabrera, A., Ferrer, J. M., Álvarez, R., & Barrera, E. (2004). Adaptación transcultural de un cuestionario para medir la calidad de vida de los pacientes con anticoagulación oral. Atencion Primaria, 34(7), 353–359.

    Article  Google Scholar 

  21. Spertus, J., Dorian, P., Bubien, R., Lewis, S., Godejohn, D., Reynolds, M. R., et al. (2011). Development and validation of the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire in patients with atrial fibrillation. Circulation Arrhythmia and Electrophysiology, 4, 15–25.

    Article  PubMed  Google Scholar 

  22. Badia, X., Arribas, F., Ormaetxe, J. M., Peinado, R., & de Los Terreros, M. S. (2007). Development of a questionnaire to measure health-related quality of life (HRQoL) in patients with atrial fibrillation (AF-QoL). Health Qual Life Outcomes, 4(5), 37.

    Article  Google Scholar 

  23. Elewa, H. F, Deremer, C. E., Keller, K., Gujral, J., & Joshua, T. V. (2013). Patient satisfaction with warfarin and willingness to switch to dabigatran: A patient survey. Journal of Thrombosis and Thrombolysis Aug 6. [Epub ahead of print].

  24. Coleman, C. I., Coleman, S. M., Vanderpoel, J., Nelson, W., Colby, J. A., Scholle, J. M., et al. (2013). Patient satisfaction with warfarin- and non-warfarin-containing thromboprophylaxis regimens for atrial fibrillation. Journal of Investigative Medicine, 61(5), 878–881.

    Article  CAS  PubMed  Google Scholar 

  25. Gage, B. F., Cardinalli, A. B., & Owens, D. K. (1996). The effect of stroke and stroke prophylaxis with aspirin or warfarin on quality of life. Archives of Internal Medicine, 156, 1829–1836.

    Article  CAS  PubMed  Google Scholar 

  26. Osterberg, L., & Blaschke, T. (2005). Adherence to medication. New England Journal of Medicine, 353, 487–497.

    Article  CAS  PubMed  Google Scholar 

  27. Barbosa, C. D., Balp, M. M., Kulich, K., et al. (2012). A literature review to explore the link between treatment satisfaction and adherence, compliance, and persistence. Patient Prefer Adherence, 6, 39–48.

    Article  PubMed  PubMed Central  Google Scholar 

  28. Revicki, D. A. (2004). Patient assessment of treatment satisfaction: Methods and practical issues. Gut, 53, iv40–44.

    Article  PubMed  PubMed Central  Google Scholar 

  29. Lindhiem, O., Bennett, C., Trentacosta, C., & McLear, C. (2014). Client preferences affect treatment satisfaction, completion, and clinical outcome: A meta-analyis. Clinical Psychology Review, 34, 506–517.

    Article  PubMed  PubMed Central  Google Scholar 

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Acknowledgements

We acknowledge the contribution of the following clinicians for their help with gathering information by interviewing their patients: Ramón Bover, Álvaro Aceña, Ana Pello, Rocío Carda, Óscar González Lorenzo, Angélica Romero, Julia Palfy. This research was funded by an unrestricted grant by Pfizer Spain S.L.U.

Author information

Authors and Affiliations

  1. Departamento de Metodología, Facultad de Psicología, Universidad Autónoma de Madrid, C/Iván Pavlov 6, 28049, Madrid, Spain

    Miguel A. Ruiz

  2. Unidad de Hematología, Hospital Universitario de Salamanca-ISBAL, Salamanca, Spain

    José Ramón González-Porras

  3. Clínica Madrid, Fuenlabrada, Spain

    José Luis Aranguren

  4. Departmento de Cardiología, Hospital Clínico San Carlos, Madrid, Spain

    Eduardo Franco

  5. Centro de salud José Marvá, Madrid, Spain

    Fernando Villasante

  6. Departmento de Cardiología, Fundación Jiménez Díaz, Madrid, Spain

    José Tuñón

  7. Servicio de hematología, Complejo Asistencial Universitario de Burgos, Burgos, Spain

    Tomás José González-López

  8. Departamento de Investigación de Resultados en Salud y Farmacoeconomía, Pfizer, S.L.U., Alcobendas, Spain

    Marina de Salas-Cansado & Javier Soto

Authors
  1. Miguel A. Ruiz
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  2. José Ramón González-Porras
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  3. José Luis Aranguren
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  4. Eduardo Franco
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  5. Fernando Villasante
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  6. José Tuñón
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  7. Tomás José González-López
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  8. Marina de Salas-Cansado
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  9. Javier Soto
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Corresponding author

Correspondence to Miguel A. Ruiz.

Ethics declarations

The Helsinki-Tokyo-Venice guidelines for human research were followed. Signed informed consent and permission to use personal records were obtained from all participating patients. The study protocol was approved by the Clinical Research Committees of the Universidad Autónoma de Madrid and the Hospital Clínico de Madrid.

Conflict of interest

This research was funded by an unrestricted grant by Pfizer SLU—Spain. Javier Soto and Marina de Salas-Cansado were employees of Pfizer SLU. All authors declare they do not have any conflict of interest.

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Ruiz, M.A., González-Porras, J.R., Aranguren, J.L. et al. Development and validation of a new questionnaire measuring treatment satisfaction in patients with non-valvular atrial fibrillation: SAFUCA® . Qual Life Res 26, 767–778 (2017). https://doi.org/10.1007/s11136-016-1474-4

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  • DOI: https://doi.org/10.1007/s11136-016-1474-4

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