Longitudinal clinical trial recruitment and retention challenges in the burn population: lessons learned from a trial examining a novel intervention for chronic neuropathic symptoms

Detalhes bibliográficos
Autor(a) principal: Ohrtman, Emily A.
Data de Publicação: 2019
Outros Autores: Zaninotto, Ana Luiza, Carvalho, Sandra, Shie, Vivian L., Leite, Jorge, Ianni, Corinne Rose, Kazis, Lewis E., Zafonte, Ross, Ryan, Colleen M., Schneider, Jeffrey C., Fregni, Felipe
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: https://hdl.handle.net/1822/70124
Resumo: Long-term trials are key to understanding chronic symptoms such as pain and itch. However, challenges such as high attrition rates and poor recruitment are common when conducting research. The aim of this work was to explore these issues within a long-term randomized control trial using transcranial direct current stimulation to treat pain and itch. This parallel double blinded, placebo-controlled randomized trial was comprised of 15 transcranial direct current stimulation visits and 7 follow-up visits. Participants were over the age of 18, had a burn injury that occurred at least 3 weeks before enrollment, and reported having pain and/or itch that was moderate to severe in intensity. A total of 31 subjects were randomized into either an active or sham transcranial direct current stimulation groups. There were no significant differences between the groups in terms of age, race, education, baseline depression, or anxiety. The median dropout time was at visit 19 (visit 16 [SE = 1.98] for the sham group and visit 19 [SE = 1.98] for the active group). Analysis showed no differences in the dropout rate between groups [chi(2)(1) = 0.003, P =.954]. The dropout rate was 46.7% for the sham group and 43.8% for the active group. Overall, 45.2% of the subjects dropped out of the trial. Long-term clinical trials are an essential part of evaluating interventions for symptoms such as chronic pain and itch. However, as seen in this trial, long-term studies in the burn population often face recruitment and adherence challenges.
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spelling Longitudinal clinical trial recruitment and retention challenges in the burn population: lessons learned from a trial examining a novel intervention for chronic neuropathic symptomsCiências Sociais::PsicologiaScience & TechnologyLong-term trials are key to understanding chronic symptoms such as pain and itch. However, challenges such as high attrition rates and poor recruitment are common when conducting research. The aim of this work was to explore these issues within a long-term randomized control trial using transcranial direct current stimulation to treat pain and itch. This parallel double blinded, placebo-controlled randomized trial was comprised of 15 transcranial direct current stimulation visits and 7 follow-up visits. Participants were over the age of 18, had a burn injury that occurred at least 3 weeks before enrollment, and reported having pain and/or itch that was moderate to severe in intensity. A total of 31 subjects were randomized into either an active or sham transcranial direct current stimulation groups. There were no significant differences between the groups in terms of age, race, education, baseline depression, or anxiety. The median dropout time was at visit 19 (visit 16 [SE = 1.98] for the sham group and visit 19 [SE = 1.98] for the active group). Analysis showed no differences in the dropout rate between groups [chi(2)(1) = 0.003, P =.954]. The dropout rate was 46.7% for the sham group and 43.8% for the active group. Overall, 45.2% of the subjects dropped out of the trial. Long-term clinical trials are an essential part of evaluating interventions for symptoms such as chronic pain and itch. However, as seen in this trial, long-term studies in the burn population often face recruitment and adherence challenges.Oxford University PressUniversidade do MinhoOhrtman, Emily A.Zaninotto, Ana LuizaCarvalho, SandraShie, Vivian L.Leite, JorgeIanni, Corinne RoseKazis, Lewis E.Zafonte, RossRyan, Colleen M.Schneider, Jeffrey C.Fregni, Felipe20192019-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/1822/70124engEmily A Ohrtman, BA, Ana Luiza Zaninotto, PhD, Sandra Carvalho, PhD, Vivian L Shie, BS, Jorge Leite, PhD, Corinne Rose Ianni, BS, Lewis E Kazis, ScD, Ross Zafonte, DO, Colleen M Ryan, MD, Jeffrey C Schneider, MD, Felipe Fregni, MD, PhD, MPH, Longitudinal Clinical Trial Recruitment and Retention Challenges in the Burn Population: Lessons Learned From a Trial Examining a Novel Intervention for Chronic Neuropathic Symptoms, Journal of Burn Care & Research, Volume 40, Issue 6, November/December 2019, Pages 792–795, https://doi.org/10.1093/jbcr/irz0841559-047X1559-048810.1093/jbcr/irz08431102438https://academic.oup.com/jbcr/article-abstract/40/6/792/5491590info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-07-21T11:55:27Zoai:repositorium.sdum.uminho.pt:1822/70124Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T18:45:00.231666Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Longitudinal clinical trial recruitment and retention challenges in the burn population: lessons learned from a trial examining a novel intervention for chronic neuropathic symptoms
title Longitudinal clinical trial recruitment and retention challenges in the burn population: lessons learned from a trial examining a novel intervention for chronic neuropathic symptoms
spellingShingle Longitudinal clinical trial recruitment and retention challenges in the burn population: lessons learned from a trial examining a novel intervention for chronic neuropathic symptoms
Ohrtman, Emily A.
Ciências Sociais::Psicologia
Science & Technology
title_short Longitudinal clinical trial recruitment and retention challenges in the burn population: lessons learned from a trial examining a novel intervention for chronic neuropathic symptoms
title_full Longitudinal clinical trial recruitment and retention challenges in the burn population: lessons learned from a trial examining a novel intervention for chronic neuropathic symptoms
title_fullStr Longitudinal clinical trial recruitment and retention challenges in the burn population: lessons learned from a trial examining a novel intervention for chronic neuropathic symptoms
title_full_unstemmed Longitudinal clinical trial recruitment and retention challenges in the burn population: lessons learned from a trial examining a novel intervention for chronic neuropathic symptoms
title_sort Longitudinal clinical trial recruitment and retention challenges in the burn population: lessons learned from a trial examining a novel intervention for chronic neuropathic symptoms
author Ohrtman, Emily A.
author_facet Ohrtman, Emily A.
Zaninotto, Ana Luiza
Carvalho, Sandra
Shie, Vivian L.
Leite, Jorge
Ianni, Corinne Rose
Kazis, Lewis E.
Zafonte, Ross
Ryan, Colleen M.
Schneider, Jeffrey C.
Fregni, Felipe
author_role author
author2 Zaninotto, Ana Luiza
Carvalho, Sandra
Shie, Vivian L.
Leite, Jorge
Ianni, Corinne Rose
Kazis, Lewis E.
Zafonte, Ross
Ryan, Colleen M.
Schneider, Jeffrey C.
Fregni, Felipe
author2_role author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universidade do Minho
dc.contributor.author.fl_str_mv Ohrtman, Emily A.
Zaninotto, Ana Luiza
Carvalho, Sandra
Shie, Vivian L.
Leite, Jorge
Ianni, Corinne Rose
Kazis, Lewis E.
Zafonte, Ross
Ryan, Colleen M.
Schneider, Jeffrey C.
Fregni, Felipe
dc.subject.por.fl_str_mv Ciências Sociais::Psicologia
Science & Technology
topic Ciências Sociais::Psicologia
Science & Technology
description Long-term trials are key to understanding chronic symptoms such as pain and itch. However, challenges such as high attrition rates and poor recruitment are common when conducting research. The aim of this work was to explore these issues within a long-term randomized control trial using transcranial direct current stimulation to treat pain and itch. This parallel double blinded, placebo-controlled randomized trial was comprised of 15 transcranial direct current stimulation visits and 7 follow-up visits. Participants were over the age of 18, had a burn injury that occurred at least 3 weeks before enrollment, and reported having pain and/or itch that was moderate to severe in intensity. A total of 31 subjects were randomized into either an active or sham transcranial direct current stimulation groups. There were no significant differences between the groups in terms of age, race, education, baseline depression, or anxiety. The median dropout time was at visit 19 (visit 16 [SE = 1.98] for the sham group and visit 19 [SE = 1.98] for the active group). Analysis showed no differences in the dropout rate between groups [chi(2)(1) = 0.003, P =.954]. The dropout rate was 46.7% for the sham group and 43.8% for the active group. Overall, 45.2% of the subjects dropped out of the trial. Long-term clinical trials are an essential part of evaluating interventions for symptoms such as chronic pain and itch. However, as seen in this trial, long-term studies in the burn population often face recruitment and adherence challenges.
publishDate 2019
dc.date.none.fl_str_mv 2019
2019-01-01T00:00:00Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://hdl.handle.net/1822/70124
url https://hdl.handle.net/1822/70124
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Emily A Ohrtman, BA, Ana Luiza Zaninotto, PhD, Sandra Carvalho, PhD, Vivian L Shie, BS, Jorge Leite, PhD, Corinne Rose Ianni, BS, Lewis E Kazis, ScD, Ross Zafonte, DO, Colleen M Ryan, MD, Jeffrey C Schneider, MD, Felipe Fregni, MD, PhD, MPH, Longitudinal Clinical Trial Recruitment and Retention Challenges in the Burn Population: Lessons Learned From a Trial Examining a Novel Intervention for Chronic Neuropathic Symptoms, Journal of Burn Care & Research, Volume 40, Issue 6, November/December 2019, Pages 792–795, https://doi.org/10.1093/jbcr/irz084
1559-047X
1559-0488
10.1093/jbcr/irz084
31102438
https://academic.oup.com/jbcr/article-abstract/40/6/792/5491590
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
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dc.publisher.none.fl_str_mv Oxford University Press
publisher.none.fl_str_mv Oxford University Press
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
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