Abstract
BackgroundEpilepsy 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.MethodsThis 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.ResultsOne 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 (Δ) 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.ConclusionsThe 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 registrationCurrent Controlled Trials ISRCTN46864306 IPHIWWE study.
Highlights
Epilepsy is a complex neurological disorder that has deep physical, social, emotional and economic repercussions for patients and their environment
Patients and methods The study was conducted in the Fundación Liga Central Contra la Epilepsia, sede Bogotá (LICCE), a non-profit organisation specialising in the treatment of outpatients with epilepsy and a referral centre for the management of this disorder in Colombia
To calculate the sample size an SD of 12 was used because in an Iranian study with epilepsy patients they reported that polymedicated patients had a QOLIE-31 of 46.98 (SD:12.07) [31], and in a preliminary study in the LICCE we found that 80.6% of women with epilepsy (WWE) who attended the medication review follow-up (MRF) service were
Summary
Epilepsy is a complex neurological disorder that has deep physical, social, emotional and economic repercussions for patients and their environment. For the treatment of epilepsy, the gender of the patient should be considered because there are conditions, including hormonal (menstrual cycle, contraception and menopause), reproductive (fertility, pregnancy and lactation) and role (childcare) conditions, that can affect and be affected by anticonvulsant therapy and that change during the different stages of life of women. Several studies have shown that people with epilepsy have lower health-related quality of life (HRQOL), especially women [4,5,6], and have associated it with depression, adverse effects, a greater number of anticonvulsants and a higher frequency of seizures [7,8,9,10]. Epilepsy is a complex chronic disorder which affects health-related quality of life (HRQOL), especially in women. 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
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