Evaluation of an electronic diary for improvement of adherence to interferon beta-1b in patients with multiple sclerosis: design and baseline results of an observational cohort study

Uwe K Zettl, Ulrike Bauer-Steinhusen, Thomas Glaser, Klaus Hechenbichler, Volker Limmroth, Study Group, Uwe K Zettl, Ulrike Bauer-Steinhusen, Thomas Glaser, Klaus Hechenbichler, Volker Limmroth, Study Group

Abstract

Background: Multiple sclerosis is a chronic, incurable, demyelinating disease that requires long-term treatment. Rates of non-adherence to prescribed therapy of up to 50% have been reported for chronic diseases. Strategies to improve treatment adherence are therefore of the utmost importance. This study will evaluate the effect of using electronic and paper diaries on treatment adherence to interferon beta-1b in patients with a first clinical isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS). Here we report on the study design and results of baseline assessments.

Methods: Patients were recruited into a prospective national multicenter cohort study for an observational period of 2 years. At the start of the study, patients opted to use a digital (DiD) or paper diary (PD) to document self-administered injections of interferon beta-1b. Adherence to treatment will be assessed on the dropout rate at the end of the observation period and on the regularity of injections every other day at 6-month intervals. Patient-related health outcomes will also be evaluated.

Results: 700 patients with a mean age of 38.3 (SD 10.3) years and a mean duration of disease since diagnosis of 3.6 (SD 5.9) years were enrolled. 383 patients opted for the digital diary, 192 of which included an injection reminder. Significantly more male than female patients opted for the DiD. Only gender was identified as a factor influencing the decision for DiD or PD. Based on rating scales, a significantly higher proportion of women had depressive comorbidities at baseline.

Conclusions: Demographic characteristics of the two cohorts were similar at baseline. More women chose a paper diary, and more had depression at baseline. These imbalances will be addressed in the analysis of the study as possible confounders influencing long-term treatment adherence in the digital and paper diary cohorts.

Trial registration: ClinicalTrials.gov NCT00902135.

Figures

Figure 1
Figure 1
Study design. After completion of the dose titration phase, patients were enrolled and opted for the DiD or PD. DiD-r and DiD-nr were randomly assigned.
Figure 2
Figure 2
Picture of the digital diary.
Figure 3
Figure 3
Total CES-D scores stratified by sex of the total population and the PD and DiD cohorts.
Figure 4
Figure 4
State of anxiety or depression assessed using the EQ-5D in men and women using a PD or DiD.

References

    1. Sabate E. Adherence to longterm therapies – Evidence for action. Geneva: World Health Organization; 2003.
    1. Vermeire E, Hearnshaw H, van Royen P, Denekens J. Patient adherence to treatment: three decades of research. A comprehensive review. J Clin Pharm Ther. 2001;26:331–42. doi: 10.1046/j.1365-2710.2001.00363.x.
    1. Golay A. Pharmacoeconomic aspects of poor adherence: can better adherence reduce health care costs? J Med Econ. 2011;14:594–608. doi: 10.3111/13696998.2011.597808.
    1. Osterberg L, Blaschke T. Adherence to medication. New Engl J Med. 2005;353:487–97. doi: 10.1056/NEJMra050100.
    1. Kern S, Reichmann H, Ziemssen T. Therapieadhärenz in der neurologischen Praxis. Nervenarzt. 2008;79:877–90. doi: 10.1007/s00115-008-2419-0.
    1. Klauer T, Zettl UK. Compliance, adherence, and the treatment of multiple sclerosis. J Neurol. 2008;255(Suppl 6):87–92.
    1. Ivanova JI, Bergman RE, Birnbaum HG, Phillips AL, Stewart M, Meletiche DM. Impact of medication adherence to disease-modifying drugs on severe relapse, and direct and indirect costs among employees with multiple sclerosis in the US. J Med Econ. 2012;15:601–09. doi: 10.3111/13696998.2012.667027.
    1. Tremlett H, van der Mei I, Fotini P, Blizzard L, Paley G, Dwyer T, Taylor B, Ponsonby AL. Adherence to the immunmodulatory drugs for multiple sclerosis: contrasting factors affect stopping drug and missing doses. Pharmaepidemiol Drug Saf. 2008;17:565–76. doi: 10.1002/pds.1593.
    1. Steinberg SC, Faris RJ, Chang CF, Chan A, Tankersey MA. Impact of adherence to interferons in the treatment of multiple sclerosis. Clin Drug Invest. 2010;30:89–100. doi: 10.2165/11533330-000000000-00000.
    1. Treadaway K, Cutter G, Salter A, Lynch S, Simsarian J, Corboy J, Jeffery D, Cohen B, Mankowski K, Guarnaccia J, Schaeffer L, Kanter R, Brandes D, Kaufman C, Duncan D, Marder E, Allen A, Harney J, Cooper J, Woo D, Stüve O, Racke M, Frohmann EM. Factors that influence adherence with disease-modifying therapy in MS. J Neurol. 2009;256:568–576. doi: 10.1007/s00415-009-0096-y.
    1. Bischoff C, Schreiber H, Bergmann A. Background information on multiple sclerosis patients stopping ongoing immunmodulatory therapy: a multicenter study in a community-based environment. J Neurol. 2012;259:2347–53. doi: 10.1007/s00415-012-6499-1.
    1. Portaccio E, Amato PM. Improving compliance with interferon-β therapy in patients with multiple sclerosis. CNS Drugs. 2009;23:453–62. doi: 10.2165/00023210-200923060-00001.
    1. Devonshire V, Lapierre Y, Macdonell R, Ramo-Tello C, Patti F, Fontoura P, Suchet L, Hyde R, Balla I, Frohmann EM, Kieseier BC. The Global adherence Project (GAP): a multicenter observational study on adherence to disease-modifying therapies in patients with relapsing-remitting multiple sclerosis. Eur J Neurol. 2010;18:69–77.
    1. Fernández O, Agüera J, Izquierdo G, Millán-Pascual J, Ramio i Torrentà L, Oliva P, Argente J, Berdei Y, Soler JM, Carmona O, Errea JM, Farrés J. Adherence to interferon beta-1b treatment in patients with multiple sclerosis in Spain. PLOS One. 2012;7:e35600. doi: 10.1371/journal.pone.0035600.
    1. Mondorf W, Siegmund B, Mahnel R, Richter H, Westfeld M, Galler A, Pollmann H. Haemoassist – a hand-held electronic patient diary for haemophilia home care. Haemophilia. 2009;15:464–72. doi: 10.1111/j.1365-2516.2008.01941.x.
    1. Goldberg J, Wolf A, Silberstein S, Gebeline-Myers C, Hopkins M, Einhorn K, Tolosa JE. Evaluation of an electronic diary as a diagnostic tool to study headache and premenstrual symptoms in migraineurs. Headache. 2007;47:384–96.
    1. Giffin NJ, Ruggiero L, Lipton RB, Silberstein SD, Tvedskov JF, Olesen J, Altman J, Goadsby PJ, Macrae A. Premonitory symptoms in migraine: an electronic diary study. Neurology. 2003;25:935–40.
    1. Cella DF, Dineen K, Arnason B, Reder A, Webster KA, Karabatsos G, Chang C, Lloyd S, Steward J, Stefoski D. Validation of the functional assessment of multiple sclerosis quality of life instrument. Neurology. 1996;47:129–39. doi: 10.1212/WNL.47.1.129.
    1. Radloff LS. The CES-D Scale: a self-report depression for research in the general population. Appl Psychol Meas. 1977;1:385–401. doi: 10.1177/014662167700100306.
    1. Weissmann MM, Sholomskas D, Pottenger M, Prusoff BA, Locke BZ. Assessing depressive symptoms in five psychiatric populations: a validation study. Am J Epidemiol. 1977;106:203–14.
    1. Pandaya R, Metz L, Patten SB. Predictive value of the CES-D in detecting depression among candidates for disease-modifying multiple sclerosis treatment. Psychosomatics. 2005;46:131–34. doi: 10.1176/appi.psy.46.2.131.
    1. Flachenecker P, Müller G, König H, Meissner H, Toyka K, Rieckmann P. “Fatigue” bei Multipler Sklerose. Entwicklung und Validierung des “Würzburger Erschöpfungsinventars bei MS”. Nervenarzt. 2006;77:165–174. doi: 10.1007/s00115-005-1990-x.
    1. Kind P. In: Quality of Life and Pharmacoeconomics in Clinical Trials. Second Edition. Spilker B, editor. Philadelphia: Lippincott-Raven Publ; 1996. The EuroQuol instrument: an index of health-related quality of life; pp. 191–201.
    1. Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS) Neurology. 1983;33:1444–52. doi: 10.1212/WNL.33.11.1444.
    1. Bussfeld P, Czekalla J. Therapieadhärenz bei Multipler Sklerose und Schizophrenie. Fortschr Neurol Psychiat. 2010;78:139–46. doi: 10.1055/s-0029-1245148.
    1. Dickhaeuser O, Stiensmeier-Pelster J, Kemke K, Juergens N. In: Paedagogische Psychologie unter gewandelten gesellschaftlichen Bedingungen. Spinath B, Heise E, editor. Universität Giessen: Schriften zur paedagogischen Psychologie; 2002. Geschlechtsunterschiede in der Computernutzung; pp. 101–112.
    1. Wynia MK, Williams Torres G, Lemieux J. Many physicians are willing to use patient’s electronic personal health records, but doctors differ by location, gender, and practice. Health Affairs. 2011;30:266–273. doi: 10.1377/hlthaff.2010.0342.
    1. Patten SB, Lavorato DH, Metz LM. Clinical correlates of CES-D depressive symptom ratings in a MS population. Gen Hosp Psychiatry. 2005;27:439–45. doi: 10.1016/j.genhosppsych.2005.06.010.
    1. Patten SB, Metz LM, Reimer MA. Biopsychosocial correlates of major depression in a multiple sclerosis population. Mult Scler. 2000;6:115–20.
    1. Chwastiak L, Ehde DM, Gibbons LE, Sullivan M, Bowen JD, Kraft GH. Depressive symptoms and severity of illness in multiple sclerosis: Epidemiologic study of a large community sample. Am J Psychiatry. 2002;159:1862–68. doi: 10.1176/appi.ajp.159.11.1862.
    1. Kessler RC, McGonagle KA, Swartz M, Blazer DG, Nelson CB. Sex and depression in the national Comorbidity Survey, I: lifetime prevalence, chronicity and recurrence. J Affect Disord. 1993;29:85–96. doi: 10.1016/0165-0327(93)90026-G.
    1. Mohr DC, Goodkin DE, Likosky W, Gatto N, Baumann KA, Rudick RA. Treatment of depression improves adherence to interferon beta-1b therapy for multiple sclerosis. Arch Neurol. 1997;54:53. doi: 10.1001/archneur.1997.00550130037013.

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