Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia: The Utility of Rapid Ethical Assessment
Identifieur interne : 000821 ( Pmc/Curation ); précédent : 000820; suivant : 000822Preparing 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.
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
Links toward previous steps (curation, corpus...)
- to stream Pmc, to step Corpus: Pour aller vers cette notice dans l'étape Curation :000821
Links to Exploration step
PMC:4788215Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia: The Utility of Rapid Ethical Assessment</title><author><name sortKey="Negussie, Henok" sort="Negussie, Henok" uniqKey="Negussie H" first="Henok" last="Negussie">Henok Negussie</name><affiliation wicri:level="1"><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></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></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></affiliation></author><author><name sortKey="Davey, Gail" sort="Davey, Gail" uniqKey="Davey G" first="Gail" last="Davey">Gail Davey</name><affiliation wicri:level="1"><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></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26967654</idno><idno type="pmc">4788215</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4788215</idno><idno type="RBID">PMC:4788215</idno><idno type="doi">10.1371/journal.pntd.0004531</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">000821</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000821</idno><idno type="wicri:Area/Pmc/Curation">000821</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000821</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia: The Utility of Rapid Ethical Assessment</title><author><name sortKey="Negussie, Henok" sort="Negussie, Henok" uniqKey="Negussie H" first="Henok" last="Negussie">Henok Negussie</name><affiliation wicri:level="1"><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></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></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></affiliation></author><author><name sortKey="Davey, Gail" sort="Davey, Gail" uniqKey="Davey G" first="Gail" last="Davey">Gail Davey</name><affiliation wicri:level="1"><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></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></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 Thoa</name></author><author><name sortKey="Long, Np" uniqKey="Long N">NP Long</name></author><author><name sortKey="Trang, Nth" uniqKey="Trang N">NTH Trang</name></author><author><name sortKey="Hirayama, K" uniqKey="Hirayama K">K Hirayama</name></author><author><name sortKey="Karbwang, J" uniqKey="Karbwang J">J Karbwang</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Manafa, O" uniqKey="Manafa O">O Manafa</name></author><author><name sortKey="Lindegger, G" uniqKey="Lindegger G">G Lindegger</name></author><author><name sortKey="Ijsselmuiden, C" uniqKey="Ijsselmuiden C">C IJsselmuiden</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Tekola, F" uniqKey="Tekola F">F Tekola</name></author><author><name sortKey="Bull, S" uniqKey="Bull S">S Bull</name></author><author><name sortKey="Farsides, B" uniqKey="Farsides B">B Farsides</name></author><author><name sortKey="Newport, M" uniqKey="Newport M">M Newport</name></author><author><name sortKey="Adeyemo, A" uniqKey="Adeyemo A">A Adeyemo</name></author><author><name sortKey="Rotimi, C" uniqKey="Rotimi C">C Rotimi</name></author><author><name sortKey="Davey, G" uniqKey="Davey G">G Davey</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Abdel Messih, Ia" uniqKey="Abdel Messih I">IA Abdel-Messih</name></author><author><name sortKey="El Setouhy, M" uniqKey="El Setouhy M">M El-Setouhy</name></author><author><name sortKey="Crouch, Mm" uniqKey="Crouch M">MM Crouch</name></author><author><name sortKey="Earhart, Kc" uniqKey="Earhart K">KC Earhart</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bower, P" uniqKey="Bower P">P Bower</name></author><author><name sortKey="Brueton, V" uniqKey="Brueton V">V Brueton</name></author><author><name sortKey="Gamble, C" uniqKey="Gamble C">C Gamble</name></author><author><name sortKey="Treweek, S" uniqKey="Treweek S">S Treweek</name></author><author><name sortKey="Smith, C" uniqKey="Smith C">C Smith</name></author><author><name sortKey="Young, B" uniqKey="Young B">B Young</name></author><author><name sortKey="Williamson, P" uniqKey="Williamson P">P Williamson</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Tekola, F" uniqKey="Tekola F">F Tekola</name></author><author><name sortKey="Bull, S" uniqKey="Bull S">S Bull</name></author><author><name sortKey="Farsides, B" uniqKey="Farsides B">B Farsides</name></author><author><name sortKey="Newport, M" uniqKey="Newport M">M Newport</name></author><author><name sortKey="Adeyemo, A" uniqKey="Adeyemo A">A Adeyemo</name></author><author><name sortKey="Rotimi, C" uniqKey="Rotimi C">C Rotimi</name></author><author><name sortKey="Davey, G" uniqKey="Davey G">G Davey</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bull, Sj" uniqKey="Bull S">SJ Bull</name></author><author><name sortKey="Farsides, B" uniqKey="Farsides B">B Farsides</name></author><author><name sortKey="Tekola, Fa" uniqKey="Tekola F">FA Tekola</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Addissie, A" uniqKey="Addissie A">A Addissie</name></author><author><name sortKey="Davey, G" uniqKey="Davey G">G Davey</name></author><author><name sortKey="Newport, M" uniqKey="Newport M">M Newport</name></author><author><name sortKey="Farsides, B" uniqKey="Farsides B">B Farsides</name></author><author><name sortKey="Feleke, Y" uniqKey="Feleke Y">Y Feleke</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Price, Ew" uniqKey="Price E">EW Price</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Deribe, K" uniqKey="Deribe K">K Deribe</name></author><author><name sortKey="Brooker, Sj" uniqKey="Brooker S">SJ Brooker</name></author><author><name sortKey="Pullan, Rl" uniqKey="Pullan R">RL Pullan</name></author><author><name sortKey="Sime, H" uniqKey="Sime H">H Sime</name></author><author><name sortKey="Gebretsadik, A" uniqKey="Gebretsadik A">A Gebretsadik</name></author><author><name sortKey="Assefa, A" uniqKey="Assefa A">A Assefa</name></author><author><name sortKey="Kebede, A" uniqKey="Kebede A">A Kebede</name></author><author><name sortKey="Hailu, A" uniqKey="Hailu A">A Hailu</name></author><author><name sortKey="Rebollo, Mp" uniqKey="Rebollo M">MP Rebollo</name></author><author><name sortKey="Shafi, O" uniqKey="Shafi O">O Shafi</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Yakob, B" uniqKey="Yakob B">B Yakob</name></author><author><name sortKey="Deribe, K" uniqKey="Deribe K">K Deribe</name></author><author><name sortKey="Davey, G" uniqKey="Davey G">G Davey</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Negussie, H" uniqKey="Negussie H">H Negussie</name></author><author><name sortKey="Kassahun, Mm" uniqKey="Kassahun M">MM Kassahun</name></author><author><name sortKey="Fegan, G" uniqKey="Fegan G">G Fegan</name></author><author><name sortKey="Njuguna, P" uniqKey="Njuguna P">P Njuguna</name></author><author><name sortKey="Enquselassie, F" uniqKey="Enquselassie F">F Enquselassie</name></author><author><name sortKey="Mckay, A" uniqKey="Mckay A">A McKay</name></author><author><name sortKey="Newport, M" uniqKey="Newport M">M Newport</name></author><author><name sortKey="Lang, T" uniqKey="Lang T">T Lang</name></author><author><name sortKey="Davey, G" uniqKey="Davey G">G Davey</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Molla, Yb" uniqKey="Molla Y">YB Molla</name></author><author><name sortKey="Tomczyk, S" uniqKey="Tomczyk S">S Tomczyk</name></author><author><name sortKey="Amberbir, T" uniqKey="Amberbir T">T Amberbir</name></author><author><name sortKey="Tamiru, A" uniqKey="Tamiru A">A Tamiru</name></author><author><name sortKey="Davey, G" uniqKey="Davey G">G Davey</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Addissie, A" uniqKey="Addissie A">A Addissie</name></author><author><name sortKey="Davey, G" uniqKey="Davey G">G Davey</name></author><author><name sortKey="Newport, M" uniqKey="Newport M">M Newport</name></author><author><name sortKey="Addissie, T" uniqKey="Addissie T">T Addissie</name></author><author><name sortKey="Macgregor, H" uniqKey="Macgregor H">H MacGregor</name></author><author><name sortKey="Feleke, Y" uniqKey="Feleke Y">Y Feleke</name></author><author><name sortKey="Farsides, B" uniqKey="Farsides B">B Farsides</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Saidu, Y" uniqKey="Saidu Y">Y Saidu</name></author><author><name sortKey="Odutola, A" uniqKey="Odutola A">A Odutola</name></author><author><name sortKey="Jafali, J" uniqKey="Jafali J">J Jafali</name></author><author><name sortKey="Ogundare, O" uniqKey="Ogundare O">O Ogundare</name></author><author><name sortKey="Worwui, A" uniqKey="Worwui A">A Worwui</name></author><author><name sortKey="Sey, G" uniqKey="Sey G">G Sey</name></author><author><name sortKey="Thomas, V" uniqKey="Thomas V">V Thomas</name></author><author><name sortKey="Stanley Batchilly, E" uniqKey="Stanley Batchilly E">E Stanley-Batchilly</name></author><author><name sortKey="Afolabi, M" uniqKey="Afolabi M">M Afolabi</name></author><author><name sortKey="Idoko, O" uniqKey="Idoko O">O Idoko</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Kengne Ouafo, J" uniqKey="Kengne Ouafo J">J Kengne-Ouafo</name></author><author><name sortKey="Nji, T" uniqKey="Nji T">T Nji</name></author><author><name sortKey="Tantoh, W" uniqKey="Tantoh W">W Tantoh</name></author><author><name sortKey="Nyoh, D" 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><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">PLoS Negl Trop Dis</journal-id><journal-id journal-id-type="iso-abbrev">PLoS Negl Trop Dis</journal-id><journal-id journal-id-type="publisher-id">plos</journal-id><journal-id journal-id-type="pmc">plosntds</journal-id><journal-title-group><journal-title>PLoS Neglected Tropical Diseases</journal-title></journal-title-group><issn pub-type="ppub">1935-2727</issn><issn pub-type="epub">1935-2735</issn><publisher><publisher-name>Public Library of Science</publisher-name><publisher-loc>San Francisco, CA USA</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26967654</article-id><article-id pub-id-type="pmc">4788215</article-id><article-id pub-id-type="doi">10.1371/journal.pntd.0004531</article-id><article-id pub-id-type="publisher-id">PNTD-D-15-01844</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Parasitic Diseases</subject><subj-group><subject>Elephantiasis</subject><subj-group><subject>Podoconiosis</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Tropical Diseases</subject><subj-group><subject>Neglected Tropical Diseases</subject><subj-group><subject>Podoconiosis</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>People and Places</subject><subj-group><subject>Geographical Locations</subject><subj-group><subject>Africa</subject><subj-group><subject>Ethiopia</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Biology and Life Sciences</subject><subj-group><subject>Neuroscience</subject><subj-group><subject>Cognitive Science</subject><subj-group><subject>Cognition</subject><subj-group><subject>Decision Making</subject></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Social Sciences</subject><subj-group><subject>Anthropology</subject><subj-group><subject>Cultural Anthropology</subject><subj-group><subject>Religion</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Social Sciences</subject><subj-group><subject>Sociology</subject><subj-group><subject>Religion</subject></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Clinical Medicine</subject><subj-group><subject>Clinical Trials</subject><subj-group><subject>Randomized Controlled Trials</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Pharmacology</subject><subj-group><subject>Drug Research and Development</subject><subj-group><subject>Clinical Trials</subject><subj-group><subject>Randomized Controlled Trials</subject></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Research and Analysis Methods</subject><subj-group><subject>Clinical Trials</subject><subj-group><subject>Randomized Controlled Trials</subject></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>People and Places</subject><subj-group><subject>Population Groupings</subject><subj-group><subject>Ethnicities</subject><subj-group><subject>Amhara People</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Biology and Life Sciences</subject><subj-group><subject>Agriculture</subject><subj-group><subject>Agrochemicals</subject><subj-group><subject>Fertilizers</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Social Sciences</subject><subj-group><subject>Sociology</subject><subj-group><subject>Criminology</subject><subj-group><subject>Police</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>People and Places</subject><subj-group><subject>Population Groupings</subject><subj-group><subject>Professions</subject><subj-group><subject>Police</subject></subj-group></subj-group></subj-group></subj-group></article-categories><title-group><article-title>Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia: The Utility of Rapid Ethical Assessment</article-title><alt-title alt-title-type="running-head">REA Prior to a Clinical Trial</alt-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Negussie</surname><given-names>Henok</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref><xref ref-type="corresp" rid="cor001">*</xref></contrib><contrib contrib-type="author"><name><surname>Addissie</surname><given-names>Thomas</given-names></name><xref ref-type="aff" rid="aff002"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Addissie</surname><given-names>Adamu</given-names></name><xref ref-type="aff" rid="aff003"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Davey</surname><given-names>Gail</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref></contrib></contrib-group><aff id="aff001"><label>1</label><addr-line>Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, United Kingdom</addr-line></aff><aff id="aff002"><label>2</label><addr-line>School of Social Anthropology, Addis Ababa University, Addis Ababa, Ethiopia</addr-line></aff><aff id="aff003"><label>3</label><addr-line>School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia</addr-line></aff><contrib-group><contrib contrib-type="editor"><name><surname>Lammie</surname><given-names>Patrick J.</given-names></name><role>Editor</role><xref ref-type="aff" rid="edit1"></xref></contrib></contrib-group><aff id="edit1"><addr-line>Centers for Disease Control and Prevention, UNITED STATES</addr-line></aff><author-notes><fn fn-type="conflict" id="coi001"><p>The authors have declared that no competing interests exist.</p></fn><fn fn-type="con" id="contrib001"><p>Conceived and designed the experiments: GD HN AA. Performed the experiments: HN TA. Analyzed the data: HN TA GD. Contributed reagents/materials/analysis tools: HN TA GD. Wrote the paper: HN. Reviewed major conclusions reached: GD. Revised the manuscript: TA AA GD.</p></fn><corresp id="cor001">* E-mail: <email>H.Seifu@bsms.ac.uk</email></corresp></author-notes><pub-date pub-type="epub"><day>11</day><month>3</month><year>2016</year></pub-date><pub-date pub-type="collection"><month>3</month><year>2016</year></pub-date><volume>10</volume><issue>3</issue><elocation-id>e0004531</elocation-id><history><date date-type="received"><day>5</day><month>11</month><year>2015</year></date><date date-type="accepted"><day>19</day><month>2</month><year>2016</year></date></history><permissions><copyright-statement>© 2016 Negussie et al</copyright-statement><copyright-year>2016</copyright-year><copyright-holder>Negussie et al</copyright-holder><license xlink:href="http://creativecommons.org/licenses/by/4.0/"><license-p>This is an open access article distributed under the terms of the <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">Creative Commons Attribution License</ext-link>, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.</license-p></license></permissions><self-uri content-type="pdf" xlink:type="simple" xlink:href="pntd.0004531.pdf"></self-uri><abstract><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></abstract><abstract abstract-type="summary"><title>Author Summary</title><p>Community-based randomised controlled trials in developing countries, especially in settings with no research experience, are faced with significant challenges around approaching the community and obtaining informed consent. We conducted a Rapid Ethical Assessment, a simple and quick qualitative technique involving interviews and focus group discussions with researchers, experts, community leaders, and community members of both gender, with and without podoconiosis, the condition being studied. We aimed to explore optimal methods to provide information about the trial and approaches to the consent process preferred by the community. Overall, suggestions were grouped into five domains: approaching patients, information provision and comprehension, decision making, constraints to participation and ways of explaining randomisation and the control group. These recommendations were used to design the information sheet and consent form and to make other changes before and during the trial. This study highlights the utility of rapid ethical assessment prior to clinical trials involving complex procedures and concepts.</p></abstract><funding-group><funding-statement>The GoLBeT trial is jointly funded by the UK Medical Research Council, the Wellcome Trust and UKAID, project grant MR/K007211/1 (<ext-link ext-link-type="uri" xlink:href="http://www.wellcome.ac.uk/Funding/Biomedical-science/Funding-schemes/Global-health-trials-scheme/index.htm">http://www.wellcome.ac.uk/Funding/Biomedical-science/Funding-schemes/Global-health-trials-scheme/index.htm</ext-link>). GD is supported by a Wellcome Trust University Award (091956), and HN by a University of Sussex Chancellor’s International Studentship. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.</funding-statement></funding-group><counts><fig-count count="0"></fig-count><table-count count="2"></table-count><page-count count="17"></page-count></counts><custom-meta-group><custom-meta id="data-availability"><meta-name>Data Availability</meta-name><meta-value>Public availability would compromise patient privacy. Data are available on request from The Wellcome Trust Brighton and Sussex Center for Global Health Research. To access the data, contact Debbie Miller at <email>D.Miller@bsms.ac.uk</email>.</meta-value></custom-meta></custom-meta-group></article-meta><notes><title>Data Availability</title><p>Public availability would compromise patient privacy. Data are available on request from The Wellcome Trust Brighton and Sussex Center for Global Health Research. To access the data, contact Debbie Miller at <email>D.Miller@bsms.ac.uk</email>.</p></notes></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Sante/explor/LymphedemaV1/Data/Pmc/Curation
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000821 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Pmc/Curation/biblio.hfd -nk 000821 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Sante
|area= LymphedemaV1
|flux= Pmc
|étape= Curation
|type= RBID
|clé= PMC:4788215
|texte= Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia: The Utility of Rapid Ethical Assessment
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Pmc/Curation/RBID.i -Sk "pubmed:26967654" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Pmc/Curation/biblio.hfd \
| NlmPubMed2Wicri -a LymphedemaV1
| This area was generated with Dilib version V0.6.31. |  |