Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia: The Utility of Rapid Ethical Assessment.
Identifieur interne : 000949 ( PubMed/Curation ); précédent : 000948; suivant : 000950Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia: The Utility of Rapid Ethical Assessment.
Auteurs : Henok Negussie [Royaume-Uni] ; Thomas Addissie [Éthiopie] ; Adamu Addissie [Éthiopie] ; Gail Davey [Royaume-Uni]Source :
- PLoS neglected tropical diseases [ 1935-2735 ] ; 2016.
Descripteurs français
- KwdFr :
- MESH :
- traitement médicamenteux : Éléphantiasis.
- éthique : Essais contrôlés randomisés comme sujet.
- Adulte, Adulte d'âge moyen, Entretiens comme sujet, Femelle, Humains, Jeune adulte, Mâle, Sujet âgé, Sujet âgé de 80 ans ou plus, Éducation pour la santé, Éthiopie.
- Wicri :
- geographic : Éthiopie.
English descriptors
- KwdEn :
- MESH :
- geographic : Ethiopia.
- drug therapy : Elephantiasis.
- ethics : Randomized Controlled Trials as Topic.
- methods : Health Education.
- Adult, Aged, Aged, 80 and over, Female, Humans, Interviews as Topic, Male, Middle Aged, Young Adult.
Abstract
Community-based randomized controlled trials are often complex pieces of research with significant challenges around the approach to the community, information provision, and decision-making, all of which are fundamental to the informed consent process. We conducted a rapid ethical assessment to guide the preparation for and conduct of a randomized controlled trial of podoconiosis treatment in northern Ethiopia.
DOI: 10.1371/journal.pntd.0004531
PubMed: 26967654
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Medical School, University of Sussex, Falmer, Brighton, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton</wicri:regionArea></affiliation></author><author><name sortKey="Addissie, Thomas" sort="Addissie, Thomas" uniqKey="Addissie T" first="Thomas" last="Addissie">Thomas Addissie</name><affiliation wicri:level="1"><nlm:affiliation>School of Social Anthropology, Addis Ababa University, Addis Ababa, Ethiopia.</nlm:affiliation><country xml:lang="fr">Éthiopie</country><wicri:regionArea>School of Social Anthropology, Addis Ababa University, Addis Ababa</wicri:regionArea></affiliation></author><author><name sortKey="Addissie, Adamu" sort="Addissie, Adamu" uniqKey="Addissie A" first="Adamu" last="Addissie">Adamu Addissie</name><affiliation wicri:level="1"><nlm:affiliation>School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia.</nlm:affiliation><country 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therapy)</term><term>Ethiopia</term><term>Female</term><term>Health Education (methods)</term><term>Humans</term><term>Interviews as Topic</term><term>Male</term><term>Middle Aged</term><term>Randomized Controlled Trials as Topic (ethics)</term><term>Young Adult</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Entretiens comme sujet</term><term>Essais contrôlés randomisés comme sujet (éthique)</term><term>Femelle</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Éducation pour la santé ()</term><term>Éléphantiasis (traitement médicamenteux)</term><term>Éthiopie</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Ethiopia</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Elephantiasis</term></keywords><keywords scheme="MESH" qualifier="ethics" xml:lang="en"><term>Randomized Controlled Trials as Topic</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Health Education</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Éléphantiasis</term></keywords><keywords scheme="MESH" qualifier="éthique" xml:lang="fr"><term>Essais contrôlés randomisés comme sujet</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Female</term><term>Humans</term><term>Interviews as Topic</term><term>Male</term><term>Middle Aged</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Entretiens comme sujet</term><term>Femelle</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Éducation pour la santé</term><term>Éthiopie</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Éthiopie</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Community-based randomized controlled trials are often complex pieces of research with significant challenges around the approach to the community, information provision, and decision-making, all of which are fundamental to the informed consent process. We conducted a rapid ethical assessment to guide the preparation for and conduct of a randomized controlled trial of podoconiosis treatment in northern Ethiopia.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26967654</PMID><DateCreated><Year>2016</Year><Month>03</Month><Day>12</Day></DateCreated><DateCompleted><Year>2016</Year><Month>08</Month><Day>02</Day></DateCompleted><DateRevised><Year>2016</Year><Month>10</Month><Day>19</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Electronic">1935-2735</ISSN><JournalIssue CitedMedium="Internet"><Volume>10</Volume><Issue>3</Issue><PubDate><Year>2016</Year><Month>Mar</Month></PubDate></JournalIssue><Title>PLoS neglected tropical diseases</Title><ISOAbbreviation>PLoS Negl Trop Dis</ISOAbbreviation></Journal><ArticleTitle>Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia: The Utility of Rapid Ethical Assessment.</ArticleTitle><Pagination><MedlinePgn>e0004531</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1371/journal.pntd.0004531</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Community-based randomized controlled trials are often complex pieces of research with significant challenges around the approach to the community, information provision, and decision-making, all of which are fundamental to the informed consent process. We conducted a rapid ethical assessment to guide the preparation for and conduct of a randomized controlled trial of podoconiosis treatment in northern Ethiopia.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">A qualitative study was carried out in Aneded woreda, East Gojjam Zone, Amhara Regional State from August to September, 2013. A total of 14 In-depth Interviews (IDIs) with researchers, experts, and leaders, and 8 Focus Group Discussions (FGDs) involving 80 participants (people of both gender, with and without podoconiosis), were conducted. Interviews were carried out in Amharic. Data analysis was started alongside collection. Final data analysis used a thematic approach based on themes identified a priori and those that emerged during the analysis.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Respondents made a range of specific suggestions, including that sensitisation meetings were called by woreda or kebele leaders or the police; that Health Extension Workers were asked to accompany the research team to patients' houses; that detailed trial information was explained by someone with deep local knowledge; that analogies from agriculture and local social organisations be used to explain randomisation; that participants in the 'delayed' intervention arm be given small incentives to continue in the trial; and that key community members be asked to quell rumours arising in the course of the trial.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">Many of these recommendations were incorporated into the preparatory phases of the trial, or were used during the course of the trial itself. This demonstrates the utility of rapid ethical assessment preceding a complex piece of research in a relatively research-naive setting.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Negussie</LastName><ForeName>Henok</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Addissie</LastName><ForeName>Thomas</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>School of Social Anthropology, Addis Ababa University, Addis Ababa, Ethiopia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Addissie</LastName><ForeName>Adamu</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Davey</LastName><ForeName>Gail</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, United Kingdom.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>091956</GrantID><Agency>Wellcome Trust</Agency><Country>United Kingdom</Country></Grant><Grant><GrantID>MR/K007211/1</GrantID><Agency>Medical Research Council</Agency><Country>United Kingdom</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>03</Month><Day>11</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>PLoS Negl Trop Dis</MedlineTA><NlmUniqueID>101291488</NlmUniqueID><ISSNLinking>1935-2727</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>J Am Coll Dent. 2014 Summer;81(3):4-13</RefSource><PMID Version="1">25951677</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Trials. 2015;16:307</RefSource><PMID Version="1">26177812</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Postgrad Med. 2001 Jan-Mar;47(1):45-50</RefSource><PMID Version="1">11590294</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Trans R Soc Trop Med Hyg. 1976;70(4):288-95</RefSource><PMID Version="1">1006757</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Clin Trials. 2006;3(3):306-13</RefSource><PMID Version="1">16895047</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Indian J Med Ethics. 2007 Jan-Mar;4(1):26-30</RefSource><PMID Version="1">18630217</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>PLoS Negl Trop Dis. 2009;3(7):e482</RefSource><PMID Version="1">19621067</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>BMC Med Ethics. 2009;10:13</RefSource><PMID Version="1">19698115</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Trans R Soc Trop Med Hyg. 2010 Jan;104(1):42-7</RefSource><PMID Version="1">19717176</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Empir Res Hum Res Ethics. 2012 Feb;7(1):37-52</RefSource><PMID Version="1">22378133</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>PLoS Negl Trop Dis. 2012;6(7):e1744</RefSource><PMID Version="1">22816005</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>JAMA. 2013 Nov 27;310(20):2191-4</RefSource><PMID Version="1">24141714</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>BMC Med Ethics. 2014;15:35</RefSource><PMID Version="1">24885049</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>BMC Public Health. 2014;14:1026</RefSource><PMID Version="1">25277694</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Trials. 2014;15:399</RefSource><PMID Version="1">25322807</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Am J Trop Med Hyg. 2015 Jan;92(1):148-58</RefSource><PMID Version="1">25404069</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Ethiop Med J. 2015 Jan;53 Suppl 1:25-33</RefSource><PMID Version="1">25816498</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Bull World Health Organ. 2015 Mar 1;93(3):186-98H</RefSource><PMID Version="1">25883410</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004604" MajorTopicYN="N">Elephantiasis</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005002" MajorTopicYN="N" Type="Geographic">Ethiopia</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006266" MajorTopicYN="N">Health Education</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" 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