{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T13:49:53Z","timestamp":1762004993131,"version":"3.37.3"},"reference-count":26,"publisher":"Springer Science and Business Media LLC","issue":"1","funder":[{"DOI":"10.13039\/501100000265","name":"Medical Research Council","doi-asserted-by":"publisher","award":["MR\/K007211\/1"],"award-info":[{"award-number":["MR\/K007211\/1"]}],"id":[{"id":"10.13039\/501100000265","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Med Res Methodol"],"published-print":{"date-parts":[[2018,12]]},"DOI":"10.1186\/s12874-018-0486-x","type":"journal-article","created":{"date-parts":[[2018,3,7]],"date-time":"2018-03-07T08:31:06Z","timestamp":1520411466000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Pragmatism in practice: lessons learned during screening and enrollment for a randomised controlled trial in rural northern Ethiopia"],"prefix":"10.1186","volume":"18","author":[{"given":"Meseret","family":"Molla","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Henok","family":"Negussie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Moses","family":"Ngari","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Esther","family":"Kivaya","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patricia","family":"Njuguna","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fikre","family":"Enqueselassie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James A.","family":"Berkley","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2796-7468","authenticated-orcid":false,"given":"Gail","family":"Davey","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2018,3,7]]},"reference":[{"unstructured":"Domanski M, McKinlay S. Successful Randomized Trials: A Handbook for the 21st Century. Philadelphia: Lippincott Williams & Wilkins; 2009.","key":"486_CR1"},{"issue":"6","key":"486_CR2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pntd.0000619","volume":"4","author":"T Lang","year":"2010","unstructured":"Lang T, White N, Tran H, Farrar J, Day N, Fitzpatrick R, Angus B, Denis D, Merson L, Cheah P, et al. Clinical research in resource-limited settings: enhancing research capacity and working together to make trials less complicated. PLoS Negl Trop Dis. 2010;4(6):e619.","journal-title":"PLoS Negl Trop Dis"},{"key":"486_CR3","doi-asserted-by":"publisher","first-page":"607","DOI":"10.1136\/archdischild-2014-306163","volume":"99","author":"J Berkley","year":"2014","unstructured":"Berkley J. Randomised trials in developing countries. Arch Dis Child. 2014;99:607\u20138.","journal-title":"Arch Dis Child"},{"issue":"1","key":"486_CR4","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2016-012332","volume":"7","author":"S Franzen","year":"2017","unstructured":"Franzen S, Chandler C, Lang T. Health research capacity development in low and middle income countries: reality or rhetoric? A systematic meta-narrative review of the qualitative literature. BMJ Open. 2017;7(1):e012332.","journal-title":"BMJ Open"},{"key":"486_CR5","doi-asserted-by":"publisher","first-page":"727","DOI":"10.1136\/jme.2004.009910","volume":"31","author":"K Moodley","year":"2005","unstructured":"Moodley K, Pather M, Myer L. Informed consent and participant perceptions of influenza vaccine trials in South Africa. J Med Ethics. 2005;31:727\u201332.","journal-title":"J Med Ethics"},{"issue":"2","key":"486_CR6","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2015-2800","volume":"137","author":"P Joseph","year":"2016","unstructured":"Joseph P, Caldwell P, Tong A, Hanson C, Craig J. Stakeholder views of clinical trials in low- and middle-income countries: a systematic review. Paediatrics. 2016;137(2):e20152800.","journal-title":"Paediatrics"},{"issue":"11","key":"486_CR7","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2013-003616","volume":"3","author":"S Franzen","year":"2013","unstructured":"Franzen S, Chandler C, Enqueselassie F, Siribaddana S, Atashili J, Lang T. Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia. BMJ Open. 2013;3(11):e003616.","journal-title":"BMJ Open"},{"key":"486_CR8","doi-asserted-by":"publisher","first-page":"285","DOI":"10.1136\/bmj.316.7127.285","volume":"316","author":"M Roland","year":"1998","unstructured":"Roland M, Torgerson D. Understanding controlled trials: what are pragmatic trials? Br Med J. 1998;316:285.","journal-title":"Br Med J"},{"doi-asserted-by":"crossref","unstructured":"Godwin M, Ruhland L, Casson I, MacDonald S, Delva D, Birtwhistle R, Lam M, Seguin R. Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity. BMC Med Res Methodol. 2003;3(28).","key":"486_CR9","DOI":"10.1186\/1471-2288-3-28"},{"key":"486_CR10","doi-asserted-by":"publisher","first-page":"8","DOI":"10.1186\/s13063-015-0818-7","volume":"16","author":"H Negussie","year":"2015","unstructured":"Negussie H, Molla M, Fegan G, Njuguna P, Enqueselassie F, McKay A, Newport M, Lang T, Davey G. GoLBeT [Gojjam Lymphoedema best practice trial]: description of study protocol for a randomised controlled trial of effectiveness of treatment for podoconiosis (non-filarial elephantiasis). Trials. 2015;16:8.","journal-title":"Trials"},{"doi-asserted-by":"crossref","unstructured":"Tomczyk S, Tamiru A, Davey G. Addressing the neglected tropical disease Podoconiosis in northern Ethiopia: lessons learned from a new community Podoconiosis program. PLoS Negl Trop Dis. 2012;6(3).","key":"486_CR11","DOI":"10.1371\/journal.pntd.0001560"},{"issue":"3","key":"486_CR12","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pntd.0004531","volume":"10","author":"H Negussie","year":"2016","unstructured":"Negussie H, Addissie A, Addissie T, Davey G. Preparing for and executing a randomised controlled trial of Podoconiosis treatment in northern Ethiopia: the utility of rapid ethical assessment. PLoS Negl Trop Dis. 2016;10(3):e0004531.","journal-title":"PLoS Negl Trop Dis"},{"key":"486_CR13","doi-asserted-by":"publisher","first-page":"454","DOI":"10.1056\/NEJMra1510059","volume":"375","author":"I Ford","year":"2016","unstructured":"Ford I, Norrie J, Trials P. N Engl J Med. 2016;375:454\u201363.","journal-title":"N Engl J Med"},{"key":"486_CR14","doi-asserted-by":"publisher","first-page":"647","DOI":"10.1186\/2193-1801-3-647","volume":"3","author":"A Tora","year":"2014","unstructured":"Tora A, Franklin H, Deribe K, Reda A, Davey G. Extent of podoconiosis-related stigma in Wolaita zone, southern Ethiopia: a cross-sectional study. Springerplus. 2014;3:647.","journal-title":"Springerplus"},{"key":"486_CR15","doi-asserted-by":"publisher","first-page":"178","DOI":"10.1186\/1471-2458-13-1178","volume":"13","author":"K Deribe","year":"2013","unstructured":"Deribe K, Tomczyk S, Mousley E, Tamiru A, Davey G. Stigma towards a neglected tropical disease: felt and enacted stigma scores among podoconiosis patients in northern Ethiopia. BMC Public Health. 2013;13:178.","journal-title":"BMC Public Health"},{"key":"486_CR16","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6939-10-13","volume":"10","author":"F Tekola","year":"2009","unstructured":"Tekola F, Bull S, Farsides B, Newport M, Adeyemo A, Rotimi C, Davey G. Impact of social stigma on the process of obtaining informed consent for genetic research on podoconiosis: a qualitative study. BMC Med Ethics. 2009;10:e13.","journal-title":"BMC Med Ethics"},{"key":"486_CR17","doi-asserted-by":"publisher","first-page":"1026","DOI":"10.1186\/1471-2458-14-1026","volume":"14","author":"J Kengne-Ouafu","year":"2014","unstructured":"Kengne-Ouafu J, Nji T, Tantoh W, Nyoh D, Tendongfor N, Enyong P, MJ N, Davey G. Perceptions of consent, permission structures and approaches to the community: a rapid ethical assessment performed in north West Cameroon. BMC Public Health. 2014;14:1026.","journal-title":"BMC Public Health"},{"key":"486_CR18","doi-asserted-by":"publisher","first-page":"621","DOI":"10.1016\/j.trstmh.2006.12.002","volume":"101","author":"K Desta","year":"2007","unstructured":"Desta K, Ashine M, Davey G. Predictive value of clinical assessment of patients with podoconiosis in an endemic community setting. Trans R Soc Trop Med Hyg. 2007;101:621\u20133.","journal-title":"Trans R Soc Trop Med Hyg"},{"key":"486_CR19","doi-asserted-by":"publisher","first-page":"997","DOI":"10.1186\/s12889-016-3669-6","volume":"16","author":"S Wanji","year":"2016","unstructured":"Wanji S, Kengne-Ouafu J, Datchoua-Poutcheu F, Njouendou A, Tayong D, Sofeu-Feugaing D, Amvongo-Adija N, Fovennso B, Longang-Tchounkeu Y, Tekola Ayele F, et al. Detecting and staging podoconiosis cases in north West Cameroon: positive predictive value of clinical screening of patients by community health workers and researchers. BMC Public Health. 2016;16:997.","journal-title":"BMC Public Health"},{"issue":"10","key":"486_CR20","doi-asserted-by":"publisher","first-page":"1277","DOI":"10.1111\/j.1365-3156.2008.02133.x","volume":"13","author":"F Tekola","year":"2008","unstructured":"Tekola F, Ayele Z, HaileMariam D, Fuller C, Davey G. Development and testing of a de novo clinical staging system for podoconiosis (endemic non-filarial elephantiasis). Tropical Med Int Health. 2008;13(10):1277\u201383.","journal-title":"Tropical Med Int Health"},{"doi-asserted-by":"crossref","unstructured":"McDonald A, Knight R, Campbell M, Entwhistle V, Grant A, Cook J, Elbourne D, Francis D, Garcia J, Roberts I, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7(9).","key":"486_CR21","DOI":"10.1186\/1745-6215-7-9"},{"key":"486_CR22","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2012-002360","volume":"3","author":"S Treweek","year":"2013","unstructured":"Treweek S, Lockhart P, Pitkethly M, Cook J, Kjeldstrom M, Johansen M, Taskila T, Sullivan F, Wilson S, Jackson C, et al. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open. 2013;3:e002360.","journal-title":"BMJ Open"},{"doi-asserted-by":"publisher","unstructured":"Kengne-Ouafu J, Millard J, Nji T, Tantoh W, Nyoh D, Tendongfor N, Enyong P, MJ N, Davey G, Wanji S. Understanding of research, genetics and genetic research in a rapid ethical assessment in north-West Cameroon. Int Health. 2015; \n                    https:\/\/doi.org\/10.1093\/inthealth\/ihv034\n                    \n                  .","key":"486_CR23","DOI":"10.1093\/inthealth\/ihv034"},{"issue":"7","key":"486_CR24","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pntd.0000482","volume":"3","author":"F Tekola","year":"2009","unstructured":"Tekola F, Bull S, Farsides B, Newport M, Adeyemo A, Rotimi C, Davey G. Tailoring consent to context: designing an appropriate consent process for a biomedical study in a low income setting. PLoS Negl Trop Dis. 2009;3(7):e482.","journal-title":"PLoS Negl Trop Dis"},{"doi-asserted-by":"crossref","unstructured":"Addissie A, Abay S, Feleke Y, Newport M, Farsides B, Davey G. Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting. BMC Med Ethics. 2016;17(40).","key":"486_CR25","DOI":"10.1186\/s12910-016-0127-z"},{"issue":"1","key":"486_CR26","first-page":"10.1371","volume":"9","author":"A Little","year":"2013","unstructured":"Little A, Medhanyie A, Yebyo H, Spigt M, Dinant G, Blanco R. Meeting community health worker needs for maternal health care service delivery using appropriate mobile Technologies in Ethiopia. PLoS One. 2013;9(1):10.1371.","journal-title":"PLoS One"}],"container-title":["BMC Medical Research Methodology"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12874-018-0486-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2019,3,6]],"date-time":"2019-03-06T19:28:02Z","timestamp":1551900482000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcmedresmethodol.biomedcentral.com\/articles\/10.1186\/s12874-018-0486-x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,3,7]]},"references-count":26,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2018,12]]}},"alternative-id":["486"],"URL":"https:\/\/doi.org\/10.1186\/s12874-018-0486-x","relation":{},"ISSN":["1471-2288"],"issn-type":[{"type":"electronic","value":"1471-2288"}],"subject":[],"published":{"date-parts":[[2018,3,7]]},"assertion":[{"value":"24 October 2017","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"27 February 2018","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 March 2018","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The trial was approved by the IRB of the College of Health Sciences, Addis Ababa University (meeting number 056\/2014; protocol number 071\/13\/SPH; approval date: 12\/01\/2014), the National Ethical Review Committee of the Ethiopian Science and Technology Agency (approval number 3\u20131\/794\/06; approval date: 02\/06\/2014), the Food, Medicine and Health Care Administration Authority (reference number 02\/6\u20131\/05\/39; approval date: 09\/04\/2014) and the Research Ethics and Governance Committee of Brighton & Sussex Medical School (approval number 13\/107\/DAV; approval date: 12\/08\/2014). Initial oral consent was sought for screening of those who fulfilled inclusion and exclusion criteria at this visit. Patients who then attended an enrolment appointment at a nearby health post were given further information about the trial (taking into account the community\u2019s expressed preferences for content and delivery of information elicited during Rapid Ethical Assessment). Individual informed consent was provided, either signed by the participant or thumbprinted and then signed by an independent witness, as agreed by the Institutional Review Boards.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Publisher\u2019s Note"}}],"article-number":"26"}}