Epilepsy & Behavior 43 (2015) 24–29
Contents lists available at ScienceDirect
Epilepsy & Behavior journal homepage: www.elsevier.com/locate/yebeh
An instrument to assess patient satisfaction with epilepsy treatment Arnaud Biraben a,⁎, Bashar Allaf b a b
Neurology Department, CHU Pontchaillou, Rennes, France Eisai S.A.S., La Défense, France
a r t i c l e
i n f o
Article history: Received 9 September 2014 Revised 29 October 2014 Accepted 29 November 2014 Available online xxxx Keywords: VAS Self-assessment Patient satisfaction Epilepsy Adherence
a b s t r a c t Aims: Patient satisfaction with antiepileptic drugs is an important component in the management of epilepsy. This study aimed to develop a visual analog scale (VAS) to evaluate patient satisfaction with the effectiveness and tolerability of the current antiepileptic treatment and to identify the most appropriate threshold scores of patient dissatisfaction predictive of a decision to change the antiepileptic drugs. Methods: This observational study was conducted among patients with epilepsy consulting a neurologist in France. Two anonymous questionnaires were used, one for patients and one for neurologists. The patients' questionnaire assessed satisfaction using a four-point Likert scale and a 10-centimeter VAS. The neurologists' questionnaire evaluated whether the neurologist decided to change the current treatment or not. The determination of the threshold scores predictive of patient dissatisfaction correlated with a change of the medication was performed using analyses of receiver operating characteristic curves. Visual analogue scale scores collected from the patient questionnaire were tested against the responses collected from the neurologist questionnaire. Results: Five hundred eighteen patient questionnaires and five hundred seven neurologist questionnaires were completed. For the satisfaction with effectiveness and tolerability, the mean VAS scores were 6.7 ± 2.8 and 7.0 ± 2.8, respectively and were, respectively, 6.9 ± 1.7 and 7.0 ± 1.6 for patients who declared to be satisfied with their current antiepileptic drugs and were, respectively, 3.4 ± 1.7 and 3.3 ± 1.9 for those who declared to be dissatisfied. The neurologist decided to change the current antiepileptic drugs in 41.1% (n = 208) of the cases principally because of inadequate effectiveness. With respect to the receiver operating characteristic curves, a VAS threshold of 6 would correctly predict the decision to change the current antiepileptic drugs with sensitivity and specificity values over 73% for both effectiveness and tolerability. Conclusions: The VAS developed in this study can help patients to evaluate their antiepileptic drugs and to facilitate timely treatment modification when the current treatment is unsatisfactory. © 2014 Elsevier Inc. All rights reserved.
1. Introduction Epilepsy affects around 500,000 persons in France [1] and is associated with a considerable health and social burden and impairment of quality of life [2,3]. Persistence of seizures may lead to the development of irreversible brain damage and associated cognitive impairment, especially in children and adolescents [4]. The overall goal of epilepsy treatment is to offer the best quality of life with no seizures and minimal treatment-related adverse events [5]. Over the last several decades, new strategies including new antiepileptic drugs (AEDs) and new surgical procedures have been developed. However, despite the fact that the new AEDs have a good safety profile, seizures in one-third of patients are still not adequately controlled [6]. One of the potential reasons for treatment failure is low adherence to AEDs. It has been estimated in a study performed in the United States among over 18,000 patients with epilepsy that the risk of seizure was 21% higher in nonadherent ⁎ Corresponding author at: Epilepsy Unit, CHU Rennes, 2 rue le Guilloux, 35000 Rennes, France. Tel.: +33 2 99 28 41 62. E-mail address: [email protected] (A. Biraben).
http://dx.doi.org/10.1016/j.yebeh.2014.11.031 1525-5050/© 2014 Elsevier Inc. All rights reserved.
patients than in adherent patients (hazard ratio: 1.205 (p = 0.0002)) [7]. In addition, the relationship between treatment satisfaction and adherence to treatment is well established. It has been reported that a low level of treatment satisfaction with respect to effectiveness and tolerability has a negative impact on adherence to treatment, particularly during the management of chronic disease [8]. If the initial choice of AEDs fails to control seizures adequately when used in an appropriate dose regimen and when the adherence to treatment is satisfactory, treatment needs to be changed in a timely manner by switching to another AED or by adding an AED in order to achieve sustained seizure control and to potentially prevent the emergence of drug-refractory epilepsy [9]. It should also be noted that the use of many AEDs is associated with the occurrence of adverse events that may be distressing to the patient and compromise medication compliance. Given that the vast majority of patients with epilepsy are treated as outpatients over long periods of time, it is important for the patient and the treating physician to evaluate the effectiveness and tolerability of AED treatment at each consultation. Patient diaries are useful tools for documenting breakthrough seizures and the occurrence of acute adverse events, and patient-reported outcome (PRO) measures such
A. Biraben, B. Allaf / Epilepsy & Behavior 43 (2015) 24–29
as the Side Effect and Life Satisfaction (SEALS) can be used to determine the tolerability of treatment and the effect of AED therapy on healthrelated quality of life [10]. In addition, patients' satisfaction with the effectiveness and tolerability of their treatment can be assessed by other PRO measures such as the Treatment Satisfaction Questionnaire for Medication (TSQM) which consists of 14 items including four domains (effectiveness, side effects, convenience, and global satisfaction) [11]. Nonetheless, it would be useful to have a simple and optimal tool which evaluates the effectiveness and tolerability of treatment during a short period of time such as the period spent in the physician waiting room. In this respect, visual analogue scales (VASs) are easy and rapid to complete and allow the patient's opinion on a given subject to be quantified as a simple unidimensional metric. In many areas of medicine and, notably, for the pain of migraine, VAS has been shown to be useful in assessing treatment response. For example, a VAS of treatment satisfaction has recently been used to inform decision-making about treatment switching in migraine [12,13]. The aims of this study were to develop a VAS to evaluate patient satisfaction with the effectiveness and tolerability of the current antiepileptic treatment and to identify the most appropriate threshold scores predictive of patient dissatisfaction. It should be noted that, in France, general practitioners (GPs) prescribe the vast majority (84%) of AEDs, whereas neurologists prescribed only 8% [14]. In this context, the VAS presented and analyzed in this study is designed to be used by the patient not only in order to evaluate his own AED treatment but also in order to help GPs identify patients who are not optimally treated and then refer them to a neurologist.
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Table 1 Details of the questionnaires used during the study. The term “tolerability” was explained to the patient as follows: tolerability is the degree of acceptability of the treatment and the presence of bothersome side effects.
2. Materials and methods
Information on demographics, clinical features, and treatments was not collected.
This was an observational survey performed in France in patients with epilepsy consulting their neurologist from November 2012 to April 2013. This survey was initiated and conducted by the Ligue Française Contre l'Epilepsie (LFCE), the French League Against Epilepsy, with the partnership of Eisai S.A.S.
reasons for doing so (Table 1). After completion, the neurologist returned the completed questionnaire by mail in a prepaid envelope.
2.1. Study population A total of 36 community- or hospital-based neurologists were contacted by the French League Against Epilepsy (LFCE) and were invited to participate in the study. All participating neurologists are involved in the management of epilepsy during their daily practice and are aware of the different therapeutic strategies in this field. The study included all outpatients with epilepsy, ≥ 18 years of age, treated with AEDs, and attending a routine follow-up visit with a participating neurologist. Hospitalized patients were not included. 2.2. Data collection Data were collected using anonymous questionnaires. Two different questionnaires were used, one for the patient and the other one for the neurologist (Table 1). The patient questionnaire was provided by the neurologist to all patients who agreed to participate in the study, together with documentation explaining the aim of the study, a brief description of the methodology, and a certificate regarding data confidentiality. The patient completed the questionnaire in the waiting room. The patient questionnaire included four questions assessing satisfaction with the effectiveness and tolerability of the current AED treatment using a four-point Likert scale and a 10-centimeter VAS (Table 1). When the questionnaire was completed, the patient was invited to fold and seal the questionnaire in order to hide the answers and to return it to the neurologist during the consultation. The second questionnaire, which was on the back of the first questionnaire, was completed by the neurologist alone without access to the patient's response. This questionnaire collected data on whether the neurologist decided to change the current AED treatment and the
2.3. Statistical analysis The analyzable population consisted of all eligible patients consulting a participating neurologist during the study period and for whom the neurologist provided a complete questionnaire. Study variables were described in the total patient population. Continuous data were expressed as mean ± standard deviation and median [range: min– max]. Categorical data were presented as frequency counts (%). A multiple logistic regression analysis was performed in order to determine which VAS scores were associated with a decision to change treatment at a probability level of 0.05. The VAS threshold most predictive of a decision to change AED treatment was assessed by constructing receiver operating characteristic (ROC) curves. Two separate analyses were performed, the first one was with regard to effectiveness, in which VAS scores from Q2 of the patient questionnaire were tested for their performance at predicting a Q1c response on the neurologist questionnaire and the second one was with regard to tolerability, in which VAS scores from Q4 of the patient questionnaire were tested against Q1d of the neurologist questionnaire. All possible VAS thresholds were tested. The optimal VAS threshold was determined as the best compromise between sensitivity and specificity as determined by the area under the ROC curve (AUC). The statistical analysis was performed using SAS software version 8.2 (SAS Institute Inc.). 2.4. Ethics The study was conducted according to the principles of Good Epidemiological Practices (European Guidelines) and French regulatory requirements. Participating patients and neurologists are volunteers and have not received any honoraria for their participation in the study.
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A. Biraben, B. Allaf / Epilepsy & Behavior 43 (2015) 24–29
Since the study had no repercussions on patient care, Ethics Committee authorization was not required. A detailed information leaflet on the objectives and conduct of the study was provided to both neurologists and their patients.
3. Results 3.1. Study population A total of 35 volunteer neurologists agreed to participate in the study, with most of them being hospital-based (71.4%; 25/35 neurologists). A total of 600 patients were invited to participate in the study, of whom 518 (86.3%) returned a completed questionnaire and constituted the study population.
3.2. Patient satisfaction
A total of 507 questionnaires were completed by the participating neurologists. In the majority of cases (58.9%; n = 299), the neurologist did not plan to change the current AED treatment of his patient. He considered that the current treatment seemed to have good effectiveness and tolerability profiles in the majority of cases (55.0%; n = 279). For 108 (21.3%) cases, the neurologist declared that he or she planned to change the current AED treatment because of inadequate effectiveness; for 29 (5.7%) cases, because the treatment was poorly tolerated; for 34 (6.7%) cases, in order to reach the minimum effective dose; and for the remaining (n = 37; 7.4%) cases, because of other reasons such as planning a pregnancy. Mean and median VAS satisfaction scores as a function of the neurologist's decision to change the current AED treatment are presented in Table 2. With respect to both effectiveness and tolerability, scores were significantly lower in patients whose treatment the neurologist had decided to change. 3.3. Determination of VAS thresholds
Overall, the majority of patients declared themselves to be satisfied with their current epilepsy treatment. A total of 388 (75.1%) patients were satisfied with the effectiveness of their treatment (217 (42.0%) patients were satisfied, and 171 (33.1%) patients were very satisfied), and 404 (80.2%) patients were satisfied with its tolerability (247 (49.0%) patients were satisfied, and 157 (31.2%) patients were very satisfied). Less than 10% of the patients were very dissatisfied with the effectiveness (n = 47; 9.1%) and the tolerability (n = 30; 6.0%) of their treatment. The distribution of the VAS scores is presented in Fig. 1. Overall, over two-thirds of the patients provided a VAS score higher than 6 (67.2%; n = 338 patients for effectiveness scores and 69.9%; n = 350 for tolerability scores). The mean VAS scores according to the level of satisfaction, measured by using the Likert scale, are presented in Table 2. Overall, the mean VAS satisfaction scores were 6.9 ± 2.8 (n = 503; [median: 7.6]) for effectiveness and 7.0 ± 2.8 (n = 501; [median: 7.6]) for tolerability of the current treatments. The mean VAS effectiveness scores were 6.8 ± 1.7 for patients satisfied and 9.1 ± 1.3 for patients very satisfied with the effectiveness of their AED treatment and were 3.4 ± 1.7 for those dissatisfied and 4.9 ± 4.4 for those very dissatisfied. With respect to tolerability, mean VAS scores were 7.0 ± 1.6 for patients satisfied and 9.21 ± 1.51 for patients very satisfied and were 3.3 ± 1.9 for those dissatisfied and 3.2 ± 4.1 for those very dissatisfied.
The ROC curves indicate that the absolute VAS scores of effectiveness and tolerability with the current treatment were highly predictive of the decision of the neurologist to change the treatment. The AUCs were 0.843 for the VAS effectiveness score and 0.848 for the VAS tolerability score. The ROC curves indicate that a VAS effectiveness score threshold of 6.1 would optimally predict the decision to change due to inadequate effectiveness with a sensitivity of 76% and a specificity of 80% (Fig. 2A) and that a VAS tolerability score threshold of 5.6 would optimally predict the decision to change due to poor tolerability with a sensitivity of 85% and a specificity of 78% (Fig. 2B). On this basis, we reiterated the ROC analyses of sensitivity and specificity by dichotomizing the VAS scores into two score categories of [0–6] and [6–10]. This demonstrated that a VAS threshold of 6 would correctly predict the decision to change the treatment with a sensitivity of 73% and a specificity of 81% for effectiveness (Fig. 2C) and with a sensitivity of 85% and a specificity of 77% for tolerability (Fig. 2D). 4. Discussion The assessment of patient satisfaction is an important component in the evaluation of quality of care in the long-term management of epilepsy. The goals of this study were to develop a visual analogue scale for patients
Fig. 1. Distribution of the VAS scores of satisfaction with antiepileptic treatments.
A. Biraben, B. Allaf / Epilepsy & Behavior 43 (2015) 24–29
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Table 2 Patients' satisfaction and concordance between VAS satisfaction scores and the decision of the neurologist to change treatment. VAS effectiveness score (0–10) Mean ± SD Median [Q1–Q3]
Mean ± SD Median [Q1–Q3] VAS tolerability score (0–10) Mean ± SD Median [Q1–Q3]
Mean ± SD Median [Q1–Q3] a
Very dissatisfied Somewhat dissatisfied (N = 45) (N = 78) 4.94 ± 4.37 3.44 ± 1.68 4.7 [0.0–10.0] 3.1 [0.5–8.7] Change of treatment due to inadequate effectiveness No Yes (N = 368) (N = 116) 7.73 ± 2.41 4.44 ± 2.31 8.2 [6.8–9.7] 4.5 [2.8–6.1]
Satisfied (N = 214) 6.85 ± 1.72 7.1 [0.0–10.0]
Very dissatisfied Somewhat dissatisfied (N = 29) (N = 67) 3.22 ± 4.14 3.34 ± 1.88 0.8 [0.0–10.0] 2.9 [0.1–10.0] Change of treatment due to poor tolerability No Yes (N = 436) (N = 47) 7.38 ± 2.51 3.49 ± 2.57 7.8 [6.3–9.5] 2.9 [1.8–5.1]
Satisfied (N = 241) 6.96 ± 1.65 7.2 [1.0–10.0]
Very satisfied (N = 165) 9.13 ± 1.27 9.6 [0.6–10.0]
p-Value
b0.001a Very satisfied (N = 152) 9.21 ± 1.51 9.7 [0.0–10.0]
p-Value
b0.001a
Wilcoxon's paired rank test.
with epilepsy and to assess satisfaction with current AED treatment in terms of effectiveness and tolerability. Treatment satisfaction was evaluated with a combination of two VASs, one pertaining to treatment effectiveness and the other one pertaining to treatment tolerability. The instrument developed in this study is designed to facilitate patients' auto-evaluation of their AED treatments and to identify those not optimally treated. This study is based on the current management of epilepsy in France, where the vast majority of patients with epilepsy are followed by general practitioners (GPs) and not specialists [14]. The VAS proposed
here is developed principally for those patients followed by a GP and who are not on optimal treatment. We suggest that the VAS developed in this study could be useful to patients with epilepsy for auto-evaluating their treatment, for involving them in the management of their own disease, and for encouraging them to consult a neurologist if necessary in order to better control their epilepsy. Many studies have shown that patients with epilepsy seek a more interactive dialog with their physicians and a greater involvement in treatment decisions [15], and the VAS could contribute to this. The VAS could also be delivered by pharmacists when
Fig. 2. ROC curves for the determination of the VAS threshold predictive of neurologists' decision to change the current AED treatment.
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filling prescriptions for AEDs. Indeed, the pharmacist is considered by patients with epilepsy as an important provider of health-care advice and information. A study performed in the USA showed that two-thirds of patients with epilepsy (65%; n = 49) consulted their community pharmacist for drug interaction information and that over half of them (56%; n = 42) consulted their community pharmacist for adverse effect information [16]. Tools to facilitate treatment modifications when current therapy is considered unsatisfactory by the patient may also help improve the treatment adherence. Optimal management of epilepsy requires not only prescription of an appropriate treatment at an adequate dose but also good adherence to treatment. Adherence to AED treatments remains problematic, and it has been shown that over 50% of patients have low or medium adherence [17,18]. Moreover, nonadherence to AED treatment is associated with increased seizure risk [7,19], increased mortality risk, poor quality of life, and higher health-care costs [19–22]. In order to improve adherence to treatments, it is important to increase patients' knowledge about the disease and involve them more during the management of their epilepsy. Our study reveals that the majority of patients who visit a neurologist for their epilepsy were satisfied with their current treatment with a corresponding mean VAS score of 6.7 ± 2.8 for satisfaction with effectiveness and a mean score of 7.0 ± 2.8 for satisfaction with tolerability. In our study, the majority of neurologists declared that they decided to maintain the current AED treatment. If they decided to change treatment, the principal reason was inadequate seizure control (21.3% of the cases). This result seems to be higher than that reported in the literature. For example, in a large international study of adverse events in patients with epilepsy, a similar proportion of patients changed treatment because of poor tolerability and lack of effectiveness (b8% in both cases) [23]. We assumed that clinically relevant VAS thresholds could be identified by correlating patients' VAS satisfaction scores with neurologists' decision to change treatment using ROC analysis. We focused on identifying the VAS threshold under which the VAS scores would be highly predictive of the neurologist's decision to change. We found this VAS threshold to be 6.1 for effectiveness and 5.6 for tolerability, suggesting that a VAS satisfaction score of between 0 and 6 would imply that the neurologist would be highly likely to consider changing the AED treatment. The face validity of the VAS was supported by the association between the VAS score and the level of satisfaction determined using the Likert scale. The proportion of patients reporting a VAS score of N 6 was N67% compared with a proportion of N 75% of patients declaring themselves satisfied or very satisfied with their current AED treatment on the Likert scale. A similar proportion of satisfied patients has been reported in other studies assessing patient satisfaction in epilepsy using direct questionnaires or visual scales [15,24,25]. This study has several limitations. Notably, the characteristics of participating patients were not collected, and, in particular, we have no information on the nature or appropriateness of the AED treatment regimen. It is possible that variables such as the type or history of epilepsy, the class of the AED, and the presence of psychiatric comorbidities, for example, may influence scoring of the VAS and that these should be taken into account in determining clinically relevant thresholds. For instance, the type of AEDs can have an influence on the occurrence of AEDs and tolerability. In addition, this study was restricted to the adult population (N18 years), and children and adolescents, who constitute a large proportion of all patients with epilepsy, were not evaluated. Consequently, the use of the VAS developed in our study cannot be considered for children without further research. Nonetheless, the hedonic visual scales developed for assessing treatment satisfaction in children may be useful for the same purpose [26]. The VAS presented in our study needs to be validated by specific statistical methods including assessment of internal consistency, factorial structure, and test– retest reliability.
5. Conclusion The patient satisfaction VAS developed in this study performed well in predicting the likelihood that the neurologist will consider changing AED medication due to inadequate efficacy or poor tolerability, with sensitivity and specificity values of over 70%. Such a VAS may be useful as a self-management tool for patients to ensure timely and adequate reevaluation of unsatisfactory AED medication. Role of the funding source The study was initiated by the French League Against Epilepsy (LFCE) with the support of Eisai S.A.S. A scientific committee from the LFCE advises on the design, implementation, and interpretation of the study results. This committee had full access to all data from the study. The corresponding author had final responsibility for the decision to submit the manuscript for publication. Contributors All authors developed the hypotheses and conceived the study. All authors contributed to the analysis and interpretation of the study results. All authors participated in the revision of the manuscript and agreed to be accountable for all aspects of the work. All authors approved the submission of this final draft. Acknowledgments The authors would like to thank all the neurologists involved in the study: Andre Obadia N, Ayrivie N, Bartolomei F, Chassagnon S, Chauvel P, Crespel A, De Toffol B, Denuelle M, Derambure P, Duche B, Dupont S, Elias Z, Gelisse P, Gros P, Hinault P, Hirsch E, Isnard J, Kahane P, Landre E, Lavernhe G, Maillard L, Mann M, Marchal C, Mazzola L, Olmi X, Pasnicu A, Pestre M, Ricard Mousnier B, Ryvlin P, Szurhaj W, Thomas P, Valenti Hirsch M P, Valton L, Vespignani H, Vignal J P, and Weill O. Declaration of interests AB has received consultancy fees from Eisai and GSK. BA was an employee of Eisai S.A.S. at the time of this study, a company that manufactures zonisamide, eslicarbazepine, perampanel, and rufinamide used in the management of epilepsy. References [1] Picot MC, Baldy-Moulinier M, Daures JP, Dujols P, Crespel A. The prevalence of epilepsy and pharmacoresistant epilepsy in adults: a population-based study in a Western European country. Epilepsia 2008;49:1230–8. [2] Baker GA, Jacoby A, Buck D, Brooks J, Potts P, Chadwick DW. The quality of life of older people with epilepsy: findings from a UK community study. Seizure 2001; 10:92–9. [3] Baker GA, Jacoby A. Health-related quality of life of adults with epilepsy. Epilepsy Behav 2002;3:560–1. [4] Baker GA, Hargis E, Hsih MM, Mounfield H, Arzimanoglou A, Glauser T, et al. Perceived impact of epilepsy in teenagers and young adults: an international survey. Epilepsy Behav 2008;12:395–401. [5] Glauser T, Ben-Menachem E, Bourgeois B, Cnaan A, Chadwick D, Guerreiro C, et al. ILAE treatment guidelines: evidence-based analysis of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes. Epilepsia 2006;47:1094–120. [6] Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, et al. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia 2010;51:1069–77. [7] Manjunath R, Davis KL, Candrilli SD, Ettinger AB. Association of antiepileptic drug nonadherence with risk of seizures in adults with epilepsy. Epilepsy Behav 2009; 14:372–8. [8] Dunbar-Jacob J, Erlen JA, Schlenk EA, Ryan CM, Sereika SM, Doswell WM. Adherence in chronic disease. Annu Rev Nurs Res 2000;18:48–90. [9] Kwan P, Brodie MJ. Refractory epilepsy: a progressive, intractable but preventable condition? Seizure 2002;11:77–84. [10] Gillham R, Bryant-Comstock L, Kane K. Validation of the side effect and life satisfaction (SEALS) inventory. Seizure 2000;9:458–63.
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[19] Ettinger AB, Manjunath R, Candrilli SD, Davis KL. Prevalence and cost of nonadherence to antiepileptic drugs in elderly patients with epilepsy. Epilepsy Behav 2009;14:324–9. [20] Bautista RE, Rundle-Gonzalez V. Effects of antiepileptic drug characteristics on medication adherence. Epilepsy Behav 2012;23:437–41. [21] Davis KL, Candrilli SD, Edin HM. Prevalence and cost of nonadherence with antiepileptic drugs in an adult managed care population. Epilepsia 2008;49:446–54. [22] Faught RE, Weiner JR, Guerin A, Cunnington MC, Duh MS. Impact of nonadherence to antiepileptic drugs on health care utilization and costs: findings from the RANSOM study. Epilepsia 2009;50:501–9. [23] Cramer JA, Steinborn B, Striano P, Hlinkova L, Bergmann A, Bacos I, et al. Noninterventional surveillance study of adverse events in patients with epilepsy. Acta Neurol Scand 2011;124:13–21. [24] Beghi E, Messina P, Pupillo E, Crichiutti G, Baglietto MG, Veggiotti P, et al. Satisfaction with antiepileptic drugs in children and adolescents with newly diagnosed and chronic epilepsy. Epilepsy Res 2012;100:142–51. [25] Viteri C, Codina M, Cobaleda S, Lahuerta J, Barriga J, Morales MD. Quality of life and treatment satisfaction in Spanish epilepsy patients on monotherapy with lamotrigine or valproic acid. Seizure 2010;19:432–8. [26] Motte J, Pedespan JM, Sevestre M, Chiron C. Acceptability and tolerance of sodium valproate, a new sustained-action granule formulation, in monotherapy for epileptic children from 3 years old. Arch Pediatr 2005;12:1533–9.
Contents lists available at ScienceDirect
Epilepsy & Behavior journal homepage: www.elsevier.com/locate/yebeh
An instrument to assess patient satisfaction with epilepsy treatment Arnaud Biraben a,⁎, Bashar Allaf b a b
Neurology Department, CHU Pontchaillou, Rennes, France Eisai S.A.S., La Défense, France
a r t i c l e
i n f o
Article history: Received 9 September 2014 Revised 29 October 2014 Accepted 29 November 2014 Available online xxxx Keywords: VAS Self-assessment Patient satisfaction Epilepsy Adherence
a b s t r a c t Aims: Patient satisfaction with antiepileptic drugs is an important component in the management of epilepsy. This study aimed to develop a visual analog scale (VAS) to evaluate patient satisfaction with the effectiveness and tolerability of the current antiepileptic treatment and to identify the most appropriate threshold scores of patient dissatisfaction predictive of a decision to change the antiepileptic drugs. Methods: This observational study was conducted among patients with epilepsy consulting a neurologist in France. Two anonymous questionnaires were used, one for patients and one for neurologists. The patients' questionnaire assessed satisfaction using a four-point Likert scale and a 10-centimeter VAS. The neurologists' questionnaire evaluated whether the neurologist decided to change the current treatment or not. The determination of the threshold scores predictive of patient dissatisfaction correlated with a change of the medication was performed using analyses of receiver operating characteristic curves. Visual analogue scale scores collected from the patient questionnaire were tested against the responses collected from the neurologist questionnaire. Results: Five hundred eighteen patient questionnaires and five hundred seven neurologist questionnaires were completed. For the satisfaction with effectiveness and tolerability, the mean VAS scores were 6.7 ± 2.8 and 7.0 ± 2.8, respectively and were, respectively, 6.9 ± 1.7 and 7.0 ± 1.6 for patients who declared to be satisfied with their current antiepileptic drugs and were, respectively, 3.4 ± 1.7 and 3.3 ± 1.9 for those who declared to be dissatisfied. The neurologist decided to change the current antiepileptic drugs in 41.1% (n = 208) of the cases principally because of inadequate effectiveness. With respect to the receiver operating characteristic curves, a VAS threshold of 6 would correctly predict the decision to change the current antiepileptic drugs with sensitivity and specificity values over 73% for both effectiveness and tolerability. Conclusions: The VAS developed in this study can help patients to evaluate their antiepileptic drugs and to facilitate timely treatment modification when the current treatment is unsatisfactory. © 2014 Elsevier Inc. All rights reserved.
1. Introduction Epilepsy affects around 500,000 persons in France [1] and is associated with a considerable health and social burden and impairment of quality of life [2,3]. Persistence of seizures may lead to the development of irreversible brain damage and associated cognitive impairment, especially in children and adolescents [4]. The overall goal of epilepsy treatment is to offer the best quality of life with no seizures and minimal treatment-related adverse events [5]. Over the last several decades, new strategies including new antiepileptic drugs (AEDs) and new surgical procedures have been developed. However, despite the fact that the new AEDs have a good safety profile, seizures in one-third of patients are still not adequately controlled [6]. One of the potential reasons for treatment failure is low adherence to AEDs. It has been estimated in a study performed in the United States among over 18,000 patients with epilepsy that the risk of seizure was 21% higher in nonadherent ⁎ Corresponding author at: Epilepsy Unit, CHU Rennes, 2 rue le Guilloux, 35000 Rennes, France. Tel.: +33 2 99 28 41 62. E-mail address: [email protected] (A. Biraben).
http://dx.doi.org/10.1016/j.yebeh.2014.11.031 1525-5050/© 2014 Elsevier Inc. All rights reserved.
patients than in adherent patients (hazard ratio: 1.205 (p = 0.0002)) [7]. In addition, the relationship between treatment satisfaction and adherence to treatment is well established. It has been reported that a low level of treatment satisfaction with respect to effectiveness and tolerability has a negative impact on adherence to treatment, particularly during the management of chronic disease [8]. If the initial choice of AEDs fails to control seizures adequately when used in an appropriate dose regimen and when the adherence to treatment is satisfactory, treatment needs to be changed in a timely manner by switching to another AED or by adding an AED in order to achieve sustained seizure control and to potentially prevent the emergence of drug-refractory epilepsy [9]. It should also be noted that the use of many AEDs is associated with the occurrence of adverse events that may be distressing to the patient and compromise medication compliance. Given that the vast majority of patients with epilepsy are treated as outpatients over long periods of time, it is important for the patient and the treating physician to evaluate the effectiveness and tolerability of AED treatment at each consultation. Patient diaries are useful tools for documenting breakthrough seizures and the occurrence of acute adverse events, and patient-reported outcome (PRO) measures such
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as the Side Effect and Life Satisfaction (SEALS) can be used to determine the tolerability of treatment and the effect of AED therapy on healthrelated quality of life [10]. In addition, patients' satisfaction with the effectiveness and tolerability of their treatment can be assessed by other PRO measures such as the Treatment Satisfaction Questionnaire for Medication (TSQM) which consists of 14 items including four domains (effectiveness, side effects, convenience, and global satisfaction) [11]. Nonetheless, it would be useful to have a simple and optimal tool which evaluates the effectiveness and tolerability of treatment during a short period of time such as the period spent in the physician waiting room. In this respect, visual analogue scales (VASs) are easy and rapid to complete and allow the patient's opinion on a given subject to be quantified as a simple unidimensional metric. In many areas of medicine and, notably, for the pain of migraine, VAS has been shown to be useful in assessing treatment response. For example, a VAS of treatment satisfaction has recently been used to inform decision-making about treatment switching in migraine [12,13]. The aims of this study were to develop a VAS to evaluate patient satisfaction with the effectiveness and tolerability of the current antiepileptic treatment and to identify the most appropriate threshold scores predictive of patient dissatisfaction. It should be noted that, in France, general practitioners (GPs) prescribe the vast majority (84%) of AEDs, whereas neurologists prescribed only 8% [14]. In this context, the VAS presented and analyzed in this study is designed to be used by the patient not only in order to evaluate his own AED treatment but also in order to help GPs identify patients who are not optimally treated and then refer them to a neurologist.
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Table 1 Details of the questionnaires used during the study. The term “tolerability” was explained to the patient as follows: tolerability is the degree of acceptability of the treatment and the presence of bothersome side effects.
2. Materials and methods
Information on demographics, clinical features, and treatments was not collected.
This was an observational survey performed in France in patients with epilepsy consulting their neurologist from November 2012 to April 2013. This survey was initiated and conducted by the Ligue Française Contre l'Epilepsie (LFCE), the French League Against Epilepsy, with the partnership of Eisai S.A.S.
reasons for doing so (Table 1). After completion, the neurologist returned the completed questionnaire by mail in a prepaid envelope.
2.1. Study population A total of 36 community- or hospital-based neurologists were contacted by the French League Against Epilepsy (LFCE) and were invited to participate in the study. All participating neurologists are involved in the management of epilepsy during their daily practice and are aware of the different therapeutic strategies in this field. The study included all outpatients with epilepsy, ≥ 18 years of age, treated with AEDs, and attending a routine follow-up visit with a participating neurologist. Hospitalized patients were not included. 2.2. Data collection Data were collected using anonymous questionnaires. Two different questionnaires were used, one for the patient and the other one for the neurologist (Table 1). The patient questionnaire was provided by the neurologist to all patients who agreed to participate in the study, together with documentation explaining the aim of the study, a brief description of the methodology, and a certificate regarding data confidentiality. The patient completed the questionnaire in the waiting room. The patient questionnaire included four questions assessing satisfaction with the effectiveness and tolerability of the current AED treatment using a four-point Likert scale and a 10-centimeter VAS (Table 1). When the questionnaire was completed, the patient was invited to fold and seal the questionnaire in order to hide the answers and to return it to the neurologist during the consultation. The second questionnaire, which was on the back of the first questionnaire, was completed by the neurologist alone without access to the patient's response. This questionnaire collected data on whether the neurologist decided to change the current AED treatment and the
2.3. Statistical analysis The analyzable population consisted of all eligible patients consulting a participating neurologist during the study period and for whom the neurologist provided a complete questionnaire. Study variables were described in the total patient population. Continuous data were expressed as mean ± standard deviation and median [range: min– max]. Categorical data were presented as frequency counts (%). A multiple logistic regression analysis was performed in order to determine which VAS scores were associated with a decision to change treatment at a probability level of 0.05. The VAS threshold most predictive of a decision to change AED treatment was assessed by constructing receiver operating characteristic (ROC) curves. Two separate analyses were performed, the first one was with regard to effectiveness, in which VAS scores from Q2 of the patient questionnaire were tested for their performance at predicting a Q1c response on the neurologist questionnaire and the second one was with regard to tolerability, in which VAS scores from Q4 of the patient questionnaire were tested against Q1d of the neurologist questionnaire. All possible VAS thresholds were tested. The optimal VAS threshold was determined as the best compromise between sensitivity and specificity as determined by the area under the ROC curve (AUC). The statistical analysis was performed using SAS software version 8.2 (SAS Institute Inc.). 2.4. Ethics The study was conducted according to the principles of Good Epidemiological Practices (European Guidelines) and French regulatory requirements. Participating patients and neurologists are volunteers and have not received any honoraria for their participation in the study.
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Since the study had no repercussions on patient care, Ethics Committee authorization was not required. A detailed information leaflet on the objectives and conduct of the study was provided to both neurologists and their patients.
3. Results 3.1. Study population A total of 35 volunteer neurologists agreed to participate in the study, with most of them being hospital-based (71.4%; 25/35 neurologists). A total of 600 patients were invited to participate in the study, of whom 518 (86.3%) returned a completed questionnaire and constituted the study population.
3.2. Patient satisfaction
A total of 507 questionnaires were completed by the participating neurologists. In the majority of cases (58.9%; n = 299), the neurologist did not plan to change the current AED treatment of his patient. He considered that the current treatment seemed to have good effectiveness and tolerability profiles in the majority of cases (55.0%; n = 279). For 108 (21.3%) cases, the neurologist declared that he or she planned to change the current AED treatment because of inadequate effectiveness; for 29 (5.7%) cases, because the treatment was poorly tolerated; for 34 (6.7%) cases, in order to reach the minimum effective dose; and for the remaining (n = 37; 7.4%) cases, because of other reasons such as planning a pregnancy. Mean and median VAS satisfaction scores as a function of the neurologist's decision to change the current AED treatment are presented in Table 2. With respect to both effectiveness and tolerability, scores were significantly lower in patients whose treatment the neurologist had decided to change. 3.3. Determination of VAS thresholds
Overall, the majority of patients declared themselves to be satisfied with their current epilepsy treatment. A total of 388 (75.1%) patients were satisfied with the effectiveness of their treatment (217 (42.0%) patients were satisfied, and 171 (33.1%) patients were very satisfied), and 404 (80.2%) patients were satisfied with its tolerability (247 (49.0%) patients were satisfied, and 157 (31.2%) patients were very satisfied). Less than 10% of the patients were very dissatisfied with the effectiveness (n = 47; 9.1%) and the tolerability (n = 30; 6.0%) of their treatment. The distribution of the VAS scores is presented in Fig. 1. Overall, over two-thirds of the patients provided a VAS score higher than 6 (67.2%; n = 338 patients for effectiveness scores and 69.9%; n = 350 for tolerability scores). The mean VAS scores according to the level of satisfaction, measured by using the Likert scale, are presented in Table 2. Overall, the mean VAS satisfaction scores were 6.9 ± 2.8 (n = 503; [median: 7.6]) for effectiveness and 7.0 ± 2.8 (n = 501; [median: 7.6]) for tolerability of the current treatments. The mean VAS effectiveness scores were 6.8 ± 1.7 for patients satisfied and 9.1 ± 1.3 for patients very satisfied with the effectiveness of their AED treatment and were 3.4 ± 1.7 for those dissatisfied and 4.9 ± 4.4 for those very dissatisfied. With respect to tolerability, mean VAS scores were 7.0 ± 1.6 for patients satisfied and 9.21 ± 1.51 for patients very satisfied and were 3.3 ± 1.9 for those dissatisfied and 3.2 ± 4.1 for those very dissatisfied.
The ROC curves indicate that the absolute VAS scores of effectiveness and tolerability with the current treatment were highly predictive of the decision of the neurologist to change the treatment. The AUCs were 0.843 for the VAS effectiveness score and 0.848 for the VAS tolerability score. The ROC curves indicate that a VAS effectiveness score threshold of 6.1 would optimally predict the decision to change due to inadequate effectiveness with a sensitivity of 76% and a specificity of 80% (Fig. 2A) and that a VAS tolerability score threshold of 5.6 would optimally predict the decision to change due to poor tolerability with a sensitivity of 85% and a specificity of 78% (Fig. 2B). On this basis, we reiterated the ROC analyses of sensitivity and specificity by dichotomizing the VAS scores into two score categories of [0–6] and [6–10]. This demonstrated that a VAS threshold of 6 would correctly predict the decision to change the treatment with a sensitivity of 73% and a specificity of 81% for effectiveness (Fig. 2C) and with a sensitivity of 85% and a specificity of 77% for tolerability (Fig. 2D). 4. Discussion The assessment of patient satisfaction is an important component in the evaluation of quality of care in the long-term management of epilepsy. The goals of this study were to develop a visual analogue scale for patients
Fig. 1. Distribution of the VAS scores of satisfaction with antiepileptic treatments.
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Table 2 Patients' satisfaction and concordance between VAS satisfaction scores and the decision of the neurologist to change treatment. VAS effectiveness score (0–10) Mean ± SD Median [Q1–Q3]
Mean ± SD Median [Q1–Q3] VAS tolerability score (0–10) Mean ± SD Median [Q1–Q3]
Mean ± SD Median [Q1–Q3] a
Very dissatisfied Somewhat dissatisfied (N = 45) (N = 78) 4.94 ± 4.37 3.44 ± 1.68 4.7 [0.0–10.0] 3.1 [0.5–8.7] Change of treatment due to inadequate effectiveness No Yes (N = 368) (N = 116) 7.73 ± 2.41 4.44 ± 2.31 8.2 [6.8–9.7] 4.5 [2.8–6.1]
Satisfied (N = 214) 6.85 ± 1.72 7.1 [0.0–10.0]
Very dissatisfied Somewhat dissatisfied (N = 29) (N = 67) 3.22 ± 4.14 3.34 ± 1.88 0.8 [0.0–10.0] 2.9 [0.1–10.0] Change of treatment due to poor tolerability No Yes (N = 436) (N = 47) 7.38 ± 2.51 3.49 ± 2.57 7.8 [6.3–9.5] 2.9 [1.8–5.1]
Satisfied (N = 241) 6.96 ± 1.65 7.2 [1.0–10.0]
Very satisfied (N = 165) 9.13 ± 1.27 9.6 [0.6–10.0]
p-Value
b0.001a Very satisfied (N = 152) 9.21 ± 1.51 9.7 [0.0–10.0]
p-Value
b0.001a
Wilcoxon's paired rank test.
with epilepsy and to assess satisfaction with current AED treatment in terms of effectiveness and tolerability. Treatment satisfaction was evaluated with a combination of two VASs, one pertaining to treatment effectiveness and the other one pertaining to treatment tolerability. The instrument developed in this study is designed to facilitate patients' auto-evaluation of their AED treatments and to identify those not optimally treated. This study is based on the current management of epilepsy in France, where the vast majority of patients with epilepsy are followed by general practitioners (GPs) and not specialists [14]. The VAS proposed
here is developed principally for those patients followed by a GP and who are not on optimal treatment. We suggest that the VAS developed in this study could be useful to patients with epilepsy for auto-evaluating their treatment, for involving them in the management of their own disease, and for encouraging them to consult a neurologist if necessary in order to better control their epilepsy. Many studies have shown that patients with epilepsy seek a more interactive dialog with their physicians and a greater involvement in treatment decisions [15], and the VAS could contribute to this. The VAS could also be delivered by pharmacists when
Fig. 2. ROC curves for the determination of the VAS threshold predictive of neurologists' decision to change the current AED treatment.
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filling prescriptions for AEDs. Indeed, the pharmacist is considered by patients with epilepsy as an important provider of health-care advice and information. A study performed in the USA showed that two-thirds of patients with epilepsy (65%; n = 49) consulted their community pharmacist for drug interaction information and that over half of them (56%; n = 42) consulted their community pharmacist for adverse effect information [16]. Tools to facilitate treatment modifications when current therapy is considered unsatisfactory by the patient may also help improve the treatment adherence. Optimal management of epilepsy requires not only prescription of an appropriate treatment at an adequate dose but also good adherence to treatment. Adherence to AED treatments remains problematic, and it has been shown that over 50% of patients have low or medium adherence [17,18]. Moreover, nonadherence to AED treatment is associated with increased seizure risk [7,19], increased mortality risk, poor quality of life, and higher health-care costs [19–22]. In order to improve adherence to treatments, it is important to increase patients' knowledge about the disease and involve them more during the management of their epilepsy. Our study reveals that the majority of patients who visit a neurologist for their epilepsy were satisfied with their current treatment with a corresponding mean VAS score of 6.7 ± 2.8 for satisfaction with effectiveness and a mean score of 7.0 ± 2.8 for satisfaction with tolerability. In our study, the majority of neurologists declared that they decided to maintain the current AED treatment. If they decided to change treatment, the principal reason was inadequate seizure control (21.3% of the cases). This result seems to be higher than that reported in the literature. For example, in a large international study of adverse events in patients with epilepsy, a similar proportion of patients changed treatment because of poor tolerability and lack of effectiveness (b8% in both cases) [23]. We assumed that clinically relevant VAS thresholds could be identified by correlating patients' VAS satisfaction scores with neurologists' decision to change treatment using ROC analysis. We focused on identifying the VAS threshold under which the VAS scores would be highly predictive of the neurologist's decision to change. We found this VAS threshold to be 6.1 for effectiveness and 5.6 for tolerability, suggesting that a VAS satisfaction score of between 0 and 6 would imply that the neurologist would be highly likely to consider changing the AED treatment. The face validity of the VAS was supported by the association between the VAS score and the level of satisfaction determined using the Likert scale. The proportion of patients reporting a VAS score of N 6 was N67% compared with a proportion of N 75% of patients declaring themselves satisfied or very satisfied with their current AED treatment on the Likert scale. A similar proportion of satisfied patients has been reported in other studies assessing patient satisfaction in epilepsy using direct questionnaires or visual scales [15,24,25]. This study has several limitations. Notably, the characteristics of participating patients were not collected, and, in particular, we have no information on the nature or appropriateness of the AED treatment regimen. It is possible that variables such as the type or history of epilepsy, the class of the AED, and the presence of psychiatric comorbidities, for example, may influence scoring of the VAS and that these should be taken into account in determining clinically relevant thresholds. For instance, the type of AEDs can have an influence on the occurrence of AEDs and tolerability. In addition, this study was restricted to the adult population (N18 years), and children and adolescents, who constitute a large proportion of all patients with epilepsy, were not evaluated. Consequently, the use of the VAS developed in our study cannot be considered for children without further research. Nonetheless, the hedonic visual scales developed for assessing treatment satisfaction in children may be useful for the same purpose [26]. The VAS presented in our study needs to be validated by specific statistical methods including assessment of internal consistency, factorial structure, and test– retest reliability.
5. Conclusion The patient satisfaction VAS developed in this study performed well in predicting the likelihood that the neurologist will consider changing AED medication due to inadequate efficacy or poor tolerability, with sensitivity and specificity values of over 70%. Such a VAS may be useful as a self-management tool for patients to ensure timely and adequate reevaluation of unsatisfactory AED medication. Role of the funding source The study was initiated by the French League Against Epilepsy (LFCE) with the support of Eisai S.A.S. A scientific committee from the LFCE advises on the design, implementation, and interpretation of the study results. This committee had full access to all data from the study. The corresponding author had final responsibility for the decision to submit the manuscript for publication. Contributors All authors developed the hypotheses and conceived the study. All authors contributed to the analysis and interpretation of the study results. All authors participated in the revision of the manuscript and agreed to be accountable for all aspects of the work. All authors approved the submission of this final draft. Acknowledgments The authors would like to thank all the neurologists involved in the study: Andre Obadia N, Ayrivie N, Bartolomei F, Chassagnon S, Chauvel P, Crespel A, De Toffol B, Denuelle M, Derambure P, Duche B, Dupont S, Elias Z, Gelisse P, Gros P, Hinault P, Hirsch E, Isnard J, Kahane P, Landre E, Lavernhe G, Maillard L, Mann M, Marchal C, Mazzola L, Olmi X, Pasnicu A, Pestre M, Ricard Mousnier B, Ryvlin P, Szurhaj W, Thomas P, Valenti Hirsch M P, Valton L, Vespignani H, Vignal J P, and Weill O. Declaration of interests AB has received consultancy fees from Eisai and GSK. BA was an employee of Eisai S.A.S. at the time of this study, a company that manufactures zonisamide, eslicarbazepine, perampanel, and rufinamide used in the management of epilepsy. References [1] Picot MC, Baldy-Moulinier M, Daures JP, Dujols P, Crespel A. The prevalence of epilepsy and pharmacoresistant epilepsy in adults: a population-based study in a Western European country. Epilepsia 2008;49:1230–8. [2] Baker GA, Jacoby A, Buck D, Brooks J, Potts P, Chadwick DW. The quality of life of older people with epilepsy: findings from a UK community study. Seizure 2001; 10:92–9. [3] Baker GA, Jacoby A. Health-related quality of life of adults with epilepsy. Epilepsy Behav 2002;3:560–1. [4] Baker GA, Hargis E, Hsih MM, Mounfield H, Arzimanoglou A, Glauser T, et al. Perceived impact of epilepsy in teenagers and young adults: an international survey. Epilepsy Behav 2008;12:395–401. [5] Glauser T, Ben-Menachem E, Bourgeois B, Cnaan A, Chadwick D, Guerreiro C, et al. ILAE treatment guidelines: evidence-based analysis of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes. Epilepsia 2006;47:1094–120. [6] Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, et al. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia 2010;51:1069–77. [7] Manjunath R, Davis KL, Candrilli SD, Ettinger AB. Association of antiepileptic drug nonadherence with risk of seizures in adults with epilepsy. Epilepsy Behav 2009; 14:372–8. [8] Dunbar-Jacob J, Erlen JA, Schlenk EA, Ryan CM, Sereika SM, Doswell WM. Adherence in chronic disease. Annu Rev Nurs Res 2000;18:48–90. [9] Kwan P, Brodie MJ. Refractory epilepsy: a progressive, intractable but preventable condition? Seizure 2002;11:77–84. [10] Gillham R, Bryant-Comstock L, Kane K. Validation of the side effect and life satisfaction (SEALS) inventory. Seizure 2000;9:458–63.
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