TREATMENT OF NEOVASCULAR AGE-RELATED MACULAR DEGENERATION PATIENTS WITH VASCULAR ENDOTHELIAL GROWTH FACTOR INHIBITORS IN EVERYDAY PRACTICE: Identification of Health Care Constraints in Germany-The PONS Study.

PURPOSE: The PONS study was conceived to analyze the extent of nonpersistence (NP) and nonadherence (NA) in the treatment of patients with neovascular age-related macular degeneration in everyday clinical practice in Germany. Further objectives were to identify factors that can affect NP and NA and to analyze clinical outcomes under everyday conditions. METHODS: Nonpersistence (no contact with doctor for at least 3 months) and NA (no treatment or follow-up for at least 6 weeks) as well as clinical data were analyzed up to 24 months retrospectively and 12 months prospectively in 480 patients with neovascular age-related macular degeneration in 23 treatment centers. Patients were interviewed for factors possibly affecting NP and NA. RESULTS: One third of patients fulfilled criteria of NA in the first 3 months and two thirds after 6 months. The NP was 18.8% after 12 months. Treatment exclusively at one center, a higher number of patients with neovascular age-related macular degeneration at the treating center, and fixed appointments were associated with a lower risk for NP. An initial gain in visual acuity after upload was not preserved after 12 months (mean change -0.5 Early Treatment Diabetic Retinopathy Study letters). Whereas visual acuity declined by 7.5 Early Treatment Diabetic Retinopathy Study letters in patients with good baseline visual acuity >20/40, visual acuity improved by 8.5 letters in patients with baseline visual acuity of ≤20/200. Only 7.5% of patients underwent an optical coherence tomography scan after 3 upload injections, and only 2.0 optical coherence tomographies were performed in the first 12 months. CONCLUSION: The NP and NA were high in our study population and are likely to have contributed to a suboptimal clinical outcome compared with randomized clinical trials. Shortcomings in the management of patients with neovascular age-related macular degeneration, including restrictions in the timely and adequate follow-up (including optical coherence tomography) and retreatment, appear to be constraining factors in Germany.

Patient Preferences in the Treatment of Neovascular Age-Related Macular Degeneration: A Discrete Choice Experiment.

PURPOSE: The objective of our study was to investigate preferences of patients with neovascular age-related macular degeneration (nAMD) for different anti-vascular endothelial growth factor (VEGF) treatment schemes. DESIGN: We used a discrete choice experiment (DCE) design as part of a telephone interview. PARTICIPANTS: Patients with nAMD aged at least 50 years were included in the study. METHODS: Telephone interviews were done between November 2012 and October 2013. MAIN OUTCOME MEASURES: In our DCE survey, we measured patient preferences toward specific levels of attributes that describe different options in the everyday intravitreal injection treatment setting: (1) treatment scheme; (2) change of visual acuity (VA); and (3) time the patient needs for each visit to the eye specialist. RESULTS: A total of 284 patients with nAMD with a mean age of 77.4±7.1 years (women: 59.9%) completed the DCE interviews. Of them, 22.9% had poor VA at study inclusion, 54.9% had moderate VA, and 14.1% had good VA; VA was not available for 8.1% of the patients. Generally, patients preferred the attribute levels "improvement in VA" and "short time per specialist visit." The results for the attribute "treatment scheme" were inconclusive because none of the attribute levels (injections every 4 weeks, every 8 weeks, and pro re nata) were associated with statistically significant utility differences. This also mirrors the relative importance of the different attributes in patient decisions: "Change of VA" influenced decision making for a treatment option in 73.6% of cases; "waiting, treatment, and travel time" influenced decision making in 21.0% of cases; and "treatment scheme" influenced decision making for a treatment option in 5.4% of cases. To obtain improved VA instead of a worsening VA, patients in our study stated to be willing to accept a very long time needed per physician visit of 21.2 hours (8.5 hours for improved rather than stable VA and 12.7 hours for stable VA rather than worsening VA). CONCLUSIONS: To prevent deterioration of VA, patients with nAMD seem to be willing to accept a high treatment burden with regular intravitreal injections at short intervals and long periods of waiting, treatment, and traveling for their consultations.

Comparative evaluation of patients' and physicians' satisfaction with interferon beta-1b therapy.

BACKGROUND: Due to the preventive nature of disease-modifying therapies for multiple sclerosis, treatment success particularly depends on adherence to therapeutic regimens and patients' perception of treatment efficacy. The latter is strongly influenced by the confidence in the involved health care professionals and the relationship to the treating physician. METHODS: In this report, we considered physicians' and patients' evaluation of satisfaction with interferon beta-1b treatment efficacy for assessing the congruence in ratings. Data were queried in a study conducted between 2009 and 2013. RESULTS: After 6 months of therapy, > 80 % of the patients and physicians (N = 445) showed high degrees of satisfaction regarding interferon beta-1b treatment, with only few physicians and patients (≤2.0 %) rating "not satisfied". The proportion of patients rating with the same category as their physicians was similar after 6 months (47 % congruence) and at the 24 months/study end visit (49 %). Discrepancies between ratings were observed with respect to study end: for patients with premature study end, more patients and physicians rated being not satisfied with the therapy, accompanied by a considerably lower congruence of 33 % compared to 54 % for patients receiving the therapy for at least 2 years and completing the study regularly. CONCLUSIONS: Regular communication between physicians and patients about their perception of therapy might improve alignment of treatment evaluation and could result in increased therapy persistence. In addition, patients' willingness to perform a long-term therapy - even in the absence of disease symptoms - might be promoted by repeated exchange between health care providers and patients with regard to realistic treatment expectations. TRIAL REGISTRATION: ClinicalTrials.gov NCT00902135 (registered May 13, 2009).

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.

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.

Adherence to Long-Term Interferon Beta-1b Injection Therapy in Patients with Multiple Sclerosis Using an Electronic Diary.

INTRODUCTION: Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system requiring long-term treatment, which is often hampered by non-adherence to self-applicable therapies, provoking continued disease activity and health care system burdens. This study assessed the influence of a personal digital assistant (PDA) with diary function (n = 339 patients) on persistence and adherence to an interferon beta treatment regimen in comparison to a paper patient diary (n = 330 patients). METHODS: Patients who recently started with subcutaneous injections of interferon beta-1b were recruited in this prospective, non-interventional, national cohort study for an observational period of 2 years after successful completion of the initial dose escalation. RESULTS: Therapy persistence as assessed by the drop-out rate within 104 weeks was about 50% in both study cohorts. In male patients, the drop-out rate was 10% lower when using a PDA compared to the non-PDA group. Use of a PDA with an injection reminder function increased adherence to the injection schedule (every other day) by a mean of 24.5 injections over 24 months in comparison to use of a PDA without injection reminder function. CONCLUSION: Persistence in this study was in the published range of observational MS studies. Furthermore, in male patients continuation of therapy might be positively influenced by use of a PDA, and both female and male patients might benefit from an integrated reminder function. In conclusion, electronic diaries reminding patients of upcoming injections can promote an improved adherence to MS therapy. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00902135. FUNDING: Bayer Vital GmbH.