Recruitment and enrollment in a randomized clinical trial of mandibular two-implant overdenture
Identifieur interne : 002267 ( Main/Exploration ); précédent : 002266; suivant : 002268Recruitment and enrollment in a randomized clinical trial of mandibular two-implant overdenture
Auteurs : Jeong-Yol Lee [Corée du Sud] ; Min-Soo Kim [Corée du Sud] ; Ha-Young Kim [Corée du Sud] ; Sang-Wan Shin [Corée du Sud]Source :
- The Journal of Advanced Prosthodontics [ 2005-7806 ] ; 2013.
Abstract
The purpose of this study was to evaluate the effectiveness of a promotion campaign for subject recruitment and selection, and reasons of withdrawal from a prospective clinical trial of mandibular two-implant supported overdenture.
The subjects of this study were participants in a randomized controlled clinical trial for investigating prognosis of implants and overdentures with attachments. Recruited subjects were classified by gender, age, and participation motives. Withdrawal rate of the participants before and after enrollment were evaluated.
177 patients were recruited and 51 patients were enrolled for the trial. Among them, 40 participants eventually took part in the trial. 116 subjects (65.5%) were recruited by advertisement and 61 (34.5%) were referred by patients of the hospital or local clinics. Regarding recruitment effectiveness, newspaper recruited the largest number of participants. With respect to referral patients, the proportion of our hospital patients was higher (37/61). Subjects in their 70s comprised the largest proportion (22/51). The male to female ratio was similar (25:26). Final withdrawal rate of all subjects were 74.0%. Among the reasons for withdrawal from enrollment (n=126) presence of remaining teeth and lack of motivation were the most common reasons.
To facilitate recruitment of clinical trial subjects and improve enrollment rate, it is important to obtain a sufficient number of researchers, perform promotion activity with diverse strategies, cooperate with local dentists, increase the research funding, and alleviate subjects' fear against clinical trials by thorough consultation.
Url:
DOI: 10.4047/jap.2013.5.2.204
PubMed: 23755348
PubMed Central: 3675295
Affiliations:
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type="main">Recruitment and enrollment in a randomized clinical trial of mandibular two-implant overdenture</title><author><name sortKey="Lee, Jeong Yol" sort="Lee, Jeong Yol" uniqKey="Lee J" first="Jeong-Yol" last="Lee">Jeong-Yol Lee</name><affiliation wicri:level="3"><nlm:aff id="A1">Department of Prosthodontics, Institute for Clinical Dental Research, KUMC, Korea University, Seoul, Republic of Korea.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Corée du Sud</country><wicri:regionArea>Department of Prosthodontics, Institute for Clinical Dental Research, KUMC, Korea University, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author><author><name sortKey="Kim, Min Soo" sort="Kim, Min Soo" uniqKey="Kim M" first="Min-Soo" last="Kim">Min-Soo Kim</name><affiliation wicri:level="3"><nlm:aff id="A1">Department of Prosthodontics, Institute for Clinical Dental Research, KUMC, Korea University, Seoul, Republic of Korea.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Corée du Sud</country><wicri:regionArea>Department of Prosthodontics, Institute for Clinical Dental Research, KUMC, Korea University, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author><author><name sortKey="Kim, Ha Young" sort="Kim, Ha Young" uniqKey="Kim H" first="Ha-Young" last="Kim">Ha-Young Kim</name><affiliation wicri:level="3"><nlm:aff id="A1">Department of Prosthodontics, Institute for Clinical Dental Research, KUMC, Korea University, Seoul, Republic of Korea.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Corée du Sud</country><wicri:regionArea>Department of Prosthodontics, Institute for Clinical Dental Research, KUMC, Korea University, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author><author><name sortKey="Shin, Sang Wan" sort="Shin, Sang Wan" uniqKey="Shin S" first="Sang-Wan" last="Shin">Sang-Wan Shin</name><affiliation wicri:level="3"><nlm:aff id="A1">Department of Prosthodontics, Institute for Clinical Dental Research, KUMC, Korea University, Seoul, Republic of Korea.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Corée du Sud</country><wicri:regionArea>Department of Prosthodontics, Institute for Clinical Dental Research, KUMC, Korea University, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author></analytic><series><title level="j">The Journal of Advanced Prosthodontics</title><idno type="ISSN">2005-7806</idno><idno type="eISSN">2005-7814</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>PURPOSE</title><p>The purpose of this study was to evaluate the effectiveness of a promotion campaign for subject recruitment and selection, and reasons of withdrawal from a prospective clinical trial of mandibular two-implant supported overdenture.</p></sec><sec><title>MATERIALS AND METHODS</title><p>The subjects of this study were participants in a randomized controlled clinical trial for investigating prognosis of implants and overdentures with attachments. Recruited subjects were classified by gender, age, and participation motives. Withdrawal rate of the participants before and after enrollment were evaluated.</p></sec><sec><title>RESULTS</title><p>177 patients were recruited and 51 patients were enrolled for the trial. Among them, 40 participants eventually took part in the trial. 116 subjects (65.5%) were recruited by advertisement and 61 (34.5%) were referred by patients of the hospital or local clinics. Regarding recruitment effectiveness, newspaper recruited the largest number of participants. With respect to referral patients, the proportion of our hospital patients was higher (37/61). Subjects in their 70s comprised the largest proportion (22/51). The male to female ratio was similar (25:26). Final withdrawal rate of all subjects were 74.0%. Among the reasons for withdrawal from enrollment (n=126) presence of remaining teeth and lack of motivation were the most common reasons.</p></sec><sec><title>CONCLUSION</title><p>To facilitate recruitment of clinical trial subjects and improve enrollment rate, it is important to obtain a sufficient number of researchers, perform promotion activity with diverse strategies, cooperate with local dentists, increase the research funding, and alleviate subjects' fear against clinical trials by thorough consultation.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Walton, Jn" uniqKey="Walton J">JN Walton</name></author><author><name sortKey="Macentee, Mi" uniqKey="Macentee M">MI MacEntee</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Walton, Jn" uniqKey="Walton J">JN Walton</name></author><author><name sortKey="Macentee, Mi" uniqKey="Macentee M">MI 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last="Lee">Jeong-Yol Lee</name></region><name sortKey="Kim, Ha Young" sort="Kim, Ha Young" uniqKey="Kim H" first="Ha-Young" last="Kim">Ha-Young Kim</name><name sortKey="Kim, Min Soo" sort="Kim, Min Soo" uniqKey="Kim M" first="Min-Soo" last="Kim">Min-Soo Kim</name><name sortKey="Shin, Sang Wan" sort="Shin, Sang Wan" uniqKey="Shin S" first="Sang-Wan" last="Shin">Sang-Wan Shin</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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