Impact of a pharmaceutical care programme on health-related quality of life among women with epilepsy: a randomised controlled trial (IPHIWWE study)

Health and Quality of Life Outcomes

Fernando Martínez-Martinez³  Pilar Garcia-Delgado³  Mario F Guerrero-Pabon¹  Martha Losada-Camacho² 

[1] Research Group FARMOL, National University of Colombia, Bogota, Colombia;Pharmacy Department, Faculty of Sciences, National University of Colombia, Bogota, Colombia;Research Group CTS-131 Pharmaceutical Care University of Granada, Granada, Spain

关键词: Women with epilepsy;    Randomised controlled trial;    Quality of life;    Pharmaceutical care;    Patient-reported outcomes (PROs);    Epilepsy;   

Others  :  1164500
DOI  :  10.1186/s12955-014-0162-8

 received in 2014-04-11, accepted in 2014-10-09,  发布年份 2014

【 摘 要 】

Background

Epilepsy is a complex chronic disorder which affects health-related quality of life (HRQOL), especially in women.

Pharmaceutical care (PC) allows direct intervention between the pharmacist, the patient and the other healthcare team members to optimise treatments in order to reduce negative outcomes related to medication and contribute to improving HRQOL.

The aim of the study was to establish the impact of the application of a pharmaceutical care programme on the HRQOL of women with epilepsy.

Methods

This study is a pragmatic randomised controlled trial involving women with epilepsy (WWE) over 18 years of age.

The intervention group (IG) received a pharmaceutical care programme consisting of medication review follow-up according to Dáder¿s method, health education and therapeutic drug monitoring of anticonvulsants.

The impact was assessed by changes in seizure frequency, in the self-administered questionnaires (the QOLIE-31, Liverpool AEP, CES-D, Haynes-Sackett test and Moriski-Green test) and between the first interview and the one at the end of six months of follow-up.

A Student¿s t-test was performed to compare the final QOLIE-31 score between groups and a paired Student¿s t-test was used to determine the change in each group between the start and the end of follow-up.

Results

One hundred eighty-two WWE entered the study and 144 (79.1%) completed it. The t-test for comparing the final QOLIE-31 scores between groups yielded a t?=??2.166 and confidence interval (CI) (95%): ?10.125; ?0.4625, p-value =0.0319. The change (?) in the QOLIE-31 score for the IG was 12.45 points (p-value <0.001) and for the control group it was 2.61 (p-value =0.072). With 10.7 as the minimally important change we found a relative risk of 2.17 (CI: 1.37; 3.43) and a number needed to treat (NNT) of 3.5.

Conclusions

The study demonstrated that the application of a pharmaceutical care programme significantly improves HRQOL in WWE. The NNT we found allows a recommendation to implement the PC programme for the additional benefit that would be obtained in patients¿ HRQOL.

Trial registration

Current Controlled Trials ISRCTN46864306 webcite IPHIWWE study.

【 授权许可】

   
2014 Losada-Camacho et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

【 参考文献 】

• [1]Gómez-Arias B, Crail-Meléndez D, López-Zapata R, Martínez-Juárez IE: Severity of anxiety and depression are related to a higher perception of adverse effects of antiepileptic drugs. Seizure 2012, 21(8):588-594.
• [2]Sahota P, Prabhakar S, Kharbanda PS, Bhansali A, Jain V, Das CP, Modi M: Seizure type, antiepileptic drugs, and reproductive endocrine dysfunction in Indian women with epilepsy: a cross-sectional study. Epilepsia 2008, 49(12):2069-2077.
• [3]Mei PF, Montenegro MA, Guerreiro MM, Guerreiro CAM: Pharmacovigilance in epileptic patients using antiepileptic drugs. Arq Neuropsiquiatr 2006, 64(2-A):198-201.
• [4]Almeida Souza Tedrus GM, Corrêa Fonseca L, Marin Carvalho R: Epilepsy and quality of life: socio-demographic and clinical aspects, and psychiatric co-morbidity. Arq Neuropsiquiatr 2013, 71(6):385-391.
• [5]Alanis-Guevara I, Peña E, Corona T, López-Ayala T, López-Mesa E, López-Gómez M: Sleep disturbances, socioeconomic status, and seizure control as main predictors of quality of life in epilepsy. Epilepsy Behav 2005, 7:481-485.
• [6]Yue L, Yu PM, Zhao DH, Wu DY, Zhu GX, Wu XY, Hong Z: Determinants of quality of life in people with epilepsy and their gender differences. Epilepsy Behav 2011, 22:692-696.
• [7]Canuet L, Ishii R, Iwase M, Ikesawa K, Kurimoto R, Azechi M, Takahashi H, Nakahashi T, Teshima Y, Takeda M: Factors associated with impaired quality of life in younger and older adults with epilepsy. Epilepsy Res 2009, 83:58-65.
• [8]Szaflarski JP, Szaflarski M: Seisure disorders, depression and health-related quality of life. Epilepsy Behav 2004, 5(1):50-57.
• [9]Hermann BP, Vickrey B, Hays RD, Cramer J, Devinsky O, Meador K, Perrine K, Myers LW, Ellison GW: A comparison of health-related quality of life in patients with epilepsy, diabetes and multiple sclerosis. Epilepsy Res 1996, 25:113-118.
• [10]Norsa¿adah B, Zainab J, Knight A: The quality of life of people with epilepsy at a tertiary referral centre in Malaysia. Health Qual Life Outcomes 2013, 11:143. BioMed Central Full Text
• [11]May TW, Pfafflin M, Coban I, Schmitz B: Frauen und epilepsie: befürchtungen, wissen, beratungsbedarf. Nervenarzt 2009, 80:174-183.
• [12][http://www.who.int/mental_health/media/en/82.pdf] webcite European Declaration on Epilepsy. Heidelberg. []
• [13]El papel del farmacéutico en el sistema de atención en salud. Informe de la reunión de la Organización Mundial de la Salud, Tokyo 1993 Ars Pharmaceutica 1995, 36:285-292.
• [14]Hepler CD, Strand LM: Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm 1990, 47:533-543.
• [15]Mahmann C, Radziwill R, Klotz JM, Jacobs AH: Health-related quality of life after isquemic stroke: the impact of pharmaceutical interventions on drug therapy (pharmaceutical care concept). Health Qual Life Outcomes 2010, 8:59. [http://www.hqlo.com/content/8/1/59] BioMed Central Full Text
• [16]Nixon A, Kerr C, Breheny K, Wild D: Patient Reported Outcome (PRO) assessment in epilepsy: a review of epilepsy-specific PROs according to the Food and Drug Administration (FDA) regulatory requirements. Health Qual Life Outcomes 2013, 11:38. BioMed Central Full Text
• [17]Koshy S: Role of pharmacists in the management of patients with epilepsy. Int J Pharm Pract 2011, 20:65-68.
• [18]Weil S, Deppe C, Noachtar S: The treatment of women with epilepsy. Dtsch Arztebl Int 2010, 107(45):787-793.
• [19]Sabater D, Silva MM, Faus MJ: Método Dáder: guía de seguimiento farmacoterapéutico. Granada, La Gráfica S.C.And Granada; 2007.
• [20]Campos MR: Cómo afrontar la epilepsia: una guía para pacientes y familiares. Entheos, Madrid; 2005.
• [21]Patsalos PN, Berry DJ, Bourgeois BF, Cloyd JC, Glauser TA, Johannessen SI, Leppik IE, Tomson T, Perucca E: Antiepileptic drugs¿best practice guidelines for therapeutic drug monitoring: a position paper by the subcommission on therapeutic drug monitoring, ILAE Commission on Therapeutic Strategies. Epilepsia 2008, 49(7):1239-1276.
• [22]Torres X, Arroyo S, Araya S, De Pablo J: Adaptación del Quality-of-Life in Epilepsy Inventory (QOLIE-31): traducción, validez y fiabilidad. Rev Psiquiatría Fac Med Barna 2000, 27(7):406-413.
• [23]Vickrey B, Perrine K, Hays R, Hermann BP, Cramer JA, Meador KJ, Devinsky O: Quality of Life in Epilepsy QOLIE-31 (version 1.0): Scoring Manual and Patient Inventory. RAND, Santa Monica, CA; 1993.
• [24]Cramer J, Brandenburg NA, Xu X, Vera-Llonch M, Oster G: The impact of seizures and adverse effects on global health ratings. Epilepsy Behav 2007, 11(2):179-184.
• [25]Carreño M, Donaire A, Falip M, Maestro I, Fernández S, Gil A, Serratosa J, Salas J, Viteri C, Llorens J, Baró E: Validation of the Spanish version of the Liverpool Adverse Events Profile in patients with epilepsy. Epilepsy Behav 2009, 15:154-159.
• [26]Gilliam F, Carter J, Vahle V: Tolerability of antiseizure medications: implications for health outcomes. Neurology 2004, 63(Suppl. 4):S9-S12.
• [27]Campo-Arias A, Díaz-Martínez LA, Rueda-Jaimes GE, Cadena-Afanador LP, Hernández NL: Psychometric properties of the CES-D scale among Colombian adults from the general population. Rev Colomb Psiquiat 2007, 36(4):664-674.
• [28]Cramer J, Blum D, Reed M, Fanning K: The influence of comorbid depression on quality of life for people with epilepsy. Epilepsy Behav 2003, 4(5):515-521.
• [29]Compliance in Health Care. Johns Hopkins University Press, Baltimore; 1979.
• [30]Morisky DE, Green LW, Levine DM: Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care 1986, 24:67-74.
• [31]Shaafi Sheida SH: Quality of life in the epileptic patients. Eur Psychiatry 2008, 23(Suppl 2):S 395.
• [32]Losada-Camacho M: Preliminary results of a pharmacotherapeutic follow-up program in women with epilepsy in Bogotá, Colombia. Vitae 2011, 18(Suppl. 1):S 49-S 50.
• [33]The R Foundation for Statistical Computing. R version 3.0.1 (2013-05-16). Copyright (C) 2010. ISBN 3-900051-07-0
• [34]Cramer JA, Hammer AE, Kustrab RP: Quality of life improvement with conversion to lamotrigine monotherapy. Epilepsy Behav 2004, 5:224-230.
• [35]Borghs S, De la Loge C, Cramer JA: Defining minimally important change in QOLIE-31 scores: estimates from three placebo-controlled lacosamide trials in patients with partial-onset seizures. Epilepsy Behav 2012, 23:230-234.
• [36]Miranda G, Martínez FN, Arceo ME: La calidad de vida de los pacientes epilépticos determinada por la aplicación de la escala QOLIE-31. Neurol Neurocir Psiquiat 2007, 40(2):50-55.
• [37]Birbeck GL, Hays RD, Cui X, Vickrey BG: Seizure reduction and quality of life improvements in people with epilepsy. Epilepsia 2002, 43(5):535-538.
• [38]Helde G, Bovin G, Brathen G, Brodtkorb E: A structured, nurse-led intervention program improves quality of life in patients with epilepsy: a randomized, controlled trial. Epilepsy Behav 2005, 7:451-457.
• [39]Wiebe S, Matijevic S, Eliasziw M, Derry PA: Clinically important change in quality of life in epilepsy. J Neurol Neurosurg Psychiatry 2002, 73:116-120.
• [40]Kanjanasilp J, Preechagoon Y, Kaewvichit S, Richards RME: Pharmaceutical care improved outcomes in epileptic patients. CMU J Nat Sci 2008, 7(1):33-45.
• [41]Fogg A, Staufenberg EF, Small I, Bhattacharya D: An exploratory study of primary care pharmacist-led epilepsy consultations. Int J Pharm Pract 2012, 20:294-302.