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      Validation of the Brazilian version of the VERITAS-Pro scale to assess adherence to prophylactic regimens in hemophilia

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          Abstract

          Introduction

          Prophylaxis is the treatment of choice for patients with severe hemophilia. Low adherence may limit the effectiveness of the prophylactic regimen, thereby compromising outcomes.

          Objective

          The objective of this study was to validate the Brazilian version of the VERITAS-Pro prophylaxis adherence scale, originally an American questionnaire that can be answered by the individual responsible for prophylaxis as well as by an observer.

          Methods

          The scale has 24 questions divided into six subscales: Routine, Dosage, Plan, Remember, Skip and Communicate. Participants were recruited at a blood center in southeastern Brazil for validation and reliability analyses. Validation measures included the results obtained using analog visual scales of adherence, interval between medication dispensed by the treatment center pharmacy and the percentage of recommended doses administered and infusions registered in the patients’ logs.

          Results

          The study included 32 individuals responsible for prophylaxis and five observers. The internal consistency was very good for the VERITAS-Pro total score, excellent for the Remember, Skip and Communicate subscales, good for the Dosage subscale, and acceptable for the Routine and Plan subscales. Twelve participants answered the questionnaire on more than one occasion to evaluate reproducibility. The intraclass correlation coefficient was excellent. Regarding convergent validity, the VERITAS-Pro scores were moderately correlated with the global adherence scale and with infusion log records, but showed a weak correlation with pharmacy dispensation records.

          Conclusion

          The Brazilian version of VERITAS-Pro is a valid and reliable instrument, enabling the understanding of specific factors related to non-adherence and allowing targeted interventions for proper treatment.

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          Most cited references22

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          Statistical methods for assessing agreement between two methods of clinical measurement.

          J Bland, D Altman (1986)
          In clinical measurement comparison of a new measurement technique with an established one is often needed to see whether they agree sufficiently for the new to replace the old. Such investigations are often analysed inappropriately, notably by using correlation coefficients. The use of correlation is misleading. An alternative approach, based on graphical techniques and simple calculations, is described, together with the relation between this analysis and the assessment of repeatability.
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            Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia.

            Marilyn Manco-Johnson, Thomas Abshire, Amy D Shapiro … (2007)
            Effective ways to prevent arthropathy in severe hemophilia are unknown. We randomly assigned young boys with severe hemophilia A to regular infusions of recombinant factor VIII (prophylaxis) or to an enhanced episodic infusion schedule of at least three doses totaling a minimum of 80 IU of factor VIII per kilogram of body weight at the time of a joint hemorrhage. The primary outcome was the incidence of bone or cartilage damage as detected in index joints (ankles, knees, and elbows) by radiography or magnetic resonance imaging (MRI). Sixty-five boys younger than 30 months of age were randomly assigned to prophylaxis (32 boys) or enhanced episodic therapy (33 boys). When the boys reached 6 years of age, 93% of those in the prophylaxis group and 55% of those in the episodic-therapy group were considered to have normal index-joint structure on MRI (P=0.006). The relative risk of MRI-detected joint damage with episodic therapy as compared with prophylaxis was 6.1 (95% confidence interval, 1.5 to 24.4). The mean annual numbers of joint and total hemorrhages were higher at study exit in the episodic-therapy group than in the prophylaxis group (P<0.001 for both comparisons). High titers of inhibitors of factor VIII developed in two boys who received prophylaxis; three boys in the episodic-therapy group had a life-threatening hemorrhage. Hospitalizations and infections associated with central-catheter placement did not differ significantly between the two groups. Prophylaxis with recombinant factor VIII can prevent joint damage and decrease the frequency of joint and other hemorrhages in young boys with severe hemophilia A. (ClinicalTrials.gov number, NCT00207597 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.
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              Barriers to compliance with prophylaxis therapy in haemophilia.

              Philip J M Johnson, S Geraghty, Beth M Hacker (2001)
              Prophylaxis, or the practice of routine replacement infusions of clotting factor concentrate in persons with severe haemophilia, is a demanding medical regimen. Prophylactic infusions require direct venepuncture or sterile entry into a central venous access device on a regular basis. A telephone survey was conducted to elicit information regarding the barriers to compliance with prophylaxis. The Mountain States Regional Haemophilia and Thrombosis Center has recommended prophylaxis to 52 male patients with haemophilia A or B. The haemophilia nurse attempted to contact all of these patients or their parents, and contact was made with 38 (73.1%) of them. Respondents were asked about the following issues: their decision to initiate prophylaxis; their self-rated compliance; the challenges, barriers, and facilitators of prophylaxis; and their perceived value of the therapy. Four patients (10.5%) elected not to begin prophylaxis. Of the 34 persons who began prophylaxis, 20 respondents (58.8%) rated their compliance as excellent. Nearly one-third of the families with excellent compliance (giving 75-100% of prescribed infusions) stated that the time-consuming nature of prophylaxis was the most significant challenge of the regimen. In addition, 58.3% of the families that gave less than the prescribed number of infusions reported that the time commitment was the primary reason for missing infusions. Knowledge of the benefits of prophylaxis was the primary facilitator of compliance for 44.1% of families. Ninety-seven percent of respondents rated prophylaxis as very valuable. These data show that despite the known benefits of prophylaxis, it is a demanding medical regimen, and compliance is imperfect. In addition, this study underscores the importance of providing continuing support and education for patients and families who are implementing prophylaxis.
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                Author and article information

                Contributors
                Adriana Aparecida Ferreira
                Journal
                Journal ID (nlm-ta): Hematol Transfus Cell Ther
                Journal ID (iso-abbrev): Hematol Transfus Cell Ther
                Title: Hematology, Transfusion and Cell Therapy
                Publisher: Sociedade Brasileira de Hematologia e Hemoterapia
                ISSN (Print): 2531-1379
                ISSN (Electronic): 2531-1387
                Publication date PMC-release: 26 November 2017
                Publication date (Print): Jan-Mar 2018
                Publication date (Electronic): 26 November 2017
                Volume: 40
                Issue: 1
                Pages: 18-24
                Affiliations
                [a ]Universidade Federal de Juiz de Fora UFJF, Juiz de Fora, MG, Brazil
                [b ]Fundação Centro de Hematologia e Hemoterapia de Minas Gerais Hemominas, Juiz de Fora, MG, Brazil
                [c ]Indiana Hemophilia and Thrombosis Center, Indianapolis, IN, USA
                Author notes
                [* ] Corresponding author at: Fundação Centro De Hematologia E Hemoterapia De Minas Gerais (Hemominas), Barão de Cataguases S/N, Juiz de Fora, MG, Brazil. adriana.hemato@ 123456gmail.com
                Article
                Publisher ID: S1516-8484(17)30124-X
                DOI: 10.1016/j.bjhh.2017.09.002
                PMC ID: 6002974
                PubMed ID: 29519367
                SO-VID: 77d4fab2-e625-49b5-ad5d-92b3b260b736
                Copyright © © 2017 Published by Elsevier Editora Ltda. on behalf of Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular.
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 4 June 2017
                Date accepted : 15 September 2017
                Categories
                Subject: Original Article

                Keywords: hemophilia,medication adherence,questionnaire,validation study
                Data availability:
                Keywords: hemophilia, medication adherence, questionnaire, validation study

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