Outcomes in registered, ongoing randomized controlled trials of patient education.

<h4>Background</h4>With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs) ev...

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Autores principales:	Cécile Pino, Isabelle Boutron, Philippe Ravaud
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2012
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/03694c2913c64d5dbda1c51823910caf
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spelling	oai:doaj.org-article:03694c2913c64d5dbda1c51823910caf2021-11-18T07:08:35ZOutcomes in registered, ongoing randomized controlled trials of patient education.1932-620310.1371/journal.pone.0042934https://doaj.org/article/03694c2913c64d5dbda1c51823910caf2012-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/22916183/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs) evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life).<h4>Methods</h4>On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1) patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2) surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge.<h4>Principal findings</h4>We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333) of all primary outcomes and 46% (286 of 623) of all secondary outcomes. Overall, 69% of trials (104 of 150) used at least one patient-important outcome as a primary outcome and 66% (99 of 150) as a secondary outcome. Finally, for 31% of trials (46 of 150), primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61) of primary outcomes, as compared with 54% (32 of 59) in malignant neoplasm and 18% (4 of 22) in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months).<h4>Conclusions</h4>There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.Cécile PinoIsabelle BoutronPhilippe RavaudPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 7, Iss 8, p e42934 (2012)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Cécile Pino Isabelle Boutron Philippe Ravaud Outcomes in registered, ongoing randomized controlled trials of patient education.
description	<h4>Background</h4>With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs) evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life).<h4>Methods</h4>On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1) patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2) surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge.<h4>Principal findings</h4>We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333) of all primary outcomes and 46% (286 of 623) of all secondary outcomes. Overall, 69% of trials (104 of 150) used at least one patient-important outcome as a primary outcome and 66% (99 of 150) as a secondary outcome. Finally, for 31% of trials (46 of 150), primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61) of primary outcomes, as compared with 54% (32 of 59) in malignant neoplasm and 18% (4 of 22) in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months).<h4>Conclusions</h4>There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.
format	article
author	Cécile Pino Isabelle Boutron Philippe Ravaud
author_facet	Cécile Pino Isabelle Boutron Philippe Ravaud
author_sort	Cécile Pino
title	Outcomes in registered, ongoing randomized controlled trials of patient education.
title_short	Outcomes in registered, ongoing randomized controlled trials of patient education.
title_full	Outcomes in registered, ongoing randomized controlled trials of patient education.
title_fullStr	Outcomes in registered, ongoing randomized controlled trials of patient education.
title_full_unstemmed	Outcomes in registered, ongoing randomized controlled trials of patient education.
title_sort	outcomes in registered, ongoing randomized controlled trials of patient education.
publisher	Public Library of Science (PLoS)
publishDate	2012
url	https://doaj.org/article/03694c2913c64d5dbda1c51823910caf
work_keys_str_mv	AT cecilepino outcomesinregisteredongoingrandomizedcontrolledtrialsofpatienteducation AT isabelleboutron outcomesinregisteredongoingrandomizedcontrolledtrialsofpatienteducation AT philipperavaud outcomesinregisteredongoingrandomizedcontrolledtrialsofpatienteducation
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Outcomes in registered, ongoing randomized controlled trials of patient education.

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