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Health and Quality of Life Outcomes

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Open Access 01-12-2014 | Research

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

Authors: Martha Losada-Camacho, Mario F. Guerrero-Pabon, Pilar Garcia-Delgado, Fernando Martínez-Martinez

Published in: Health and Quality of Life Outcomes | Issue 1/2014

Abstract

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 (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.

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 IPHIWWE study.

Available only for authorised users

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Title: Impact of a pharmaceutical care programme on health-related quality of life among women with epilepsy: a randomised controlled trial (IPHIWWE study)
Authors: Martha Losada-Camacho
Mario F. Guerrero-Pabon
Pilar Garcia-Delgado
Fernando Martínez-Martinez
Publication date: 01-12-2014
Publisher: BioMed Central
Published in: Health and Quality of Life Outcomes / Issue 1/2014
Electronic ISSN: 1477-7525
DOI: https://doi.org/10.1186/s12955-014-0162-8

At a glance: The STEP trials

Springer Medicine

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

Abstract

Background

Methods

Results

Conclusions

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Trial registration

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