Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia: The Utility of Rapid Ethical Assessment
Identifieur interne : 000C58 ( Main/Exploration ); précédent : 000C57; suivant : 000C59Preparing 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 [ 1935-2727 ] ; 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.
A qualitative study was carried out in Aneded
Respondents made a range of specific suggestions, including that sensitisation meetings were called by
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.
Url:
DOI: 10.1371/journal.pntd.0004531
PubMed: 26967654
PubMed Central: 4788215
Affiliations:
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Sussex, Falmer, Brighton</wicri:regionArea><orgName type="university">Université du Sussex</orgName><placeName><settlement type="city">Brighton</settlement><settlement type="town">Falmer</settlement><region type="nation">Angleterre</region><region nuts="2" type="region">Sussex de l'Est</region></placeName></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:aff id="aff002"><addr-line>School of Social Anthropology, Addis Ababa University, Addis Ababa, Ethiopia</addr-line></nlm:aff><country xml:lang="fr">Éthiopie</country><wicri:regionArea>School of Social Anthropology, Addis Ababa University, Addis Ababa</wicri:regionArea><wicri:noRegion>Addis Ababa</wicri:noRegion></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:aff id="aff003"><addr-line>School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia</addr-line></nlm:aff><country xml:lang="fr">Éthiopie</country><wicri:regionArea>School of Public Health, Addis Ababa University, Addis Ababa</wicri:regionArea><wicri:noRegion>Addis Ababa</wicri:noRegion></affiliation></author><author><name sortKey="Davey, Gail" sort="Davey, Gail" uniqKey="Davey G" first="Gail" last="Davey">Gail Davey</name><affiliation wicri:level="4"><nlm:aff id="aff001"><addr-line>Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton</wicri:regionArea><orgName type="university">Université du Sussex</orgName><placeName><settlement type="city">Brighton</settlement><settlement type="town">Falmer</settlement><region type="nation">Angleterre</region><region nuts="2" type="region">Sussex de l'Est</region></placeName></affiliation></author></analytic><series><title level="j">PLoS Neglected Tropical Diseases</title><idno type="ISSN">1935-2727</idno><idno type="eISSN">1935-2735</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Elephantiasis (drug 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"><sec id="sec001"><title>Background</title><p>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.</p></sec><sec id="sec002"><title>Methods</title><p>A qualitative study was carried out in Aneded <italic>woreda</italic>, 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 <italic>a priori</italic> and those that emerged during the analysis.</p></sec><sec id="sec003"><title>Results</title><p>Respondents made a range of specific suggestions, including that sensitisation meetings were called by <italic>woreda</italic> or <italic>kebele</italic> 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.</p></sec><sec id="sec004"><title>Conclusion</title><p>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.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Krosin, Mt" uniqKey="Krosin M">MT Krosin</name></author><author><name sortKey="Klitzman, R" uniqKey="Klitzman R">R Klitzman</name></author><author><name sortKey="Levin, B" uniqKey="Levin B">B Levin</name></author><author><name sortKey="Cheng, J" uniqKey="Cheng J">J Cheng</name></author><author><name sortKey="Ranney, Ml" uniqKey="Ranney M">ML Ranney</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Tam, Nt" uniqKey="Tam N">NT Tam</name></author><author><name sortKey="Huy, Nt" uniqKey="Huy N">NT Huy</name></author><author><name sortKey="Thoa, Ltb" uniqKey="Thoa L">LTB 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uniqKey="Nyoh D">D Nyoh</name></author><author><name sortKey="Tendongfor, N" uniqKey="Tendongfor N">N Tendongfor</name></author><author><name sortKey="Enyong, P" uniqKey="Enyong P">P Enyong</name></author><author><name sortKey="Newport, M" uniqKey="Newport M">M Newport</name></author><author><name sortKey="Davey, G" uniqKey="Davey G">G Davey</name></author><author><name sortKey="Wanji, S" uniqKey="Wanji S">S Wanji</name></author></analytic></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Royaume-Uni</li><li>Éthiopie</li></country><region><li>Angleterre</li><li>Sussex de l'Est</li></region><settlement><li>Brighton</li><li>Falmer</li></settlement><orgName><li>Université du Sussex</li></orgName></list><tree><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Negussie, Henok" sort="Negussie, Henok" uniqKey="Negussie H" first="Henok" last="Negussie">Henok Negussie</name></region><name sortKey="Davey, Gail" sort="Davey, Gail" uniqKey="Davey G" first="Gail" last="Davey">Gail Davey</name></country><country name="Éthiopie"><noRegion><name sortKey="Addissie, Thomas" sort="Addissie, Thomas" uniqKey="Addissie T" first="Thomas" last="Addissie">Thomas Addissie</name></noRegion><name sortKey="Addissie, Adamu" sort="Addissie, Adamu" uniqKey="Addissie A" first="Adamu" last="Addissie">Adamu Addissie</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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