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Recruitment and enrollment in a randomized clinical trial of mandibular two-implant overdenture.

Lee JY, Kim MS, Kim HY, Shin SW - J Adv Prosthodont (2013)

Bottom Line: 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%.

View Article: PubMed Central - PubMed

Affiliation: Department of Prosthodontics, Institute for Clinical Dental Research, KUMC, Korea University, Seoul, Republic of Korea.

ABSTRACT

Purpose: 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.

Materials and methods: 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.

Results: 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.

Conclusion: 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.

No MeSH data available.


Related in: MedlinePlus

Age distribution of participants (n=51).
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Related In: Results  -  Collection

License
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Figure 2: Age distribution of participants (n=51).

Mentions: Regarding types of recruitment interventions, 116 subjects (65.5%) were recruited by the advertising campaign and 61 patients (34.5%) were referred from patients of our hospital or local clinics. Regarding promotion effectiveness, newspaper promotion recruited the largest number of subjects, followed by internet articles and "education session on a denture". Printed advertisement such as posters recruited the least number of subjects. With respect to referred patients, the proportion of our hospital patients was higher (37/61), followed by referral patients from other hospitals or local clinics and those introduced by participants of other clinical trials (Fig. 1). Ages of the subjects ranged from 50s to 80s and subjects in their 70s occupied the largest proportion (22/51) (Fig. 2). The male to female ratio was similar (25:26) (Fig. 3).


Recruitment and enrollment in a randomized clinical trial of mandibular two-implant overdenture.

Lee JY, Kim MS, Kim HY, Shin SW - J Adv Prosthodont (2013)

Age distribution of participants (n=51).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3675295&req=5

Figure 2: Age distribution of participants (n=51).
Mentions: Regarding types of recruitment interventions, 116 subjects (65.5%) were recruited by the advertising campaign and 61 patients (34.5%) were referred from patients of our hospital or local clinics. Regarding promotion effectiveness, newspaper promotion recruited the largest number of subjects, followed by internet articles and "education session on a denture". Printed advertisement such as posters recruited the least number of subjects. With respect to referred patients, the proportion of our hospital patients was higher (37/61), followed by referral patients from other hospitals or local clinics and those introduced by participants of other clinical trials (Fig. 1). Ages of the subjects ranged from 50s to 80s and subjects in their 70s occupied the largest proportion (22/51) (Fig. 2). The male to female ratio was similar (25:26) (Fig. 3).

Bottom Line: 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%.

View Article: PubMed Central - PubMed

Affiliation: Department of Prosthodontics, Institute for Clinical Dental Research, KUMC, Korea University, Seoul, Republic of Korea.

ABSTRACT

Purpose: 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.

Materials and methods: 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.

Results: 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.

Conclusion: 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.

No MeSH data available.


Related in: MedlinePlus