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Recruitment and retention of women in a large randomized control trial to reduce repeat preterm births: the Philadelphia Collaborative Preterm Prevention Project.

Webb DA, Coyne JC, Goldenberg RL, Hogan VK, Elo IT, Bloch JR, Mathew L, Bennett IM, Dennis EF, Culhane JF - BMC Med Res Methodol (2010)

Bottom Line: Consenting women were disproportionately from minority and low SES backgrounds: 71.5% consenting were African American, versus 38.8% not consenting.There were no differences in follow-up rates according to race/ethnicity, SES or other factors.Greater retention of the intervention group may reflect the highly-valued nature of the medical and behavior services constituting the intervention arms of the Project.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Adolescent Medicine, Children's Hospital of Philadelphia, 3535 Market Street, Philadelphia, PA 19104, USA. WEBBD@email.chop.edu

ABSTRACT

Background: Recruitment and retention of patients for randomized control trial (RCT) studies can provide formidable challenges, particularly with minority and underserved populations. Data are reported for the Philadelphia Collaborative Preterm Prevention Project (PCPPP), a large RCT targeting risk factors for repeat preterm births among women who previously delivered premature (< 35 weeks gestation) infants.

Methods: Design of the PCPPP incorporated strategies to maximize recruitment and retention. These included an advanced database system tracking follow-up status and assessment completion rates; cultural sensitivity training for staff; communication to the community and eligible women of the benefits of participation; financial incentives; assistance with transportation and supervised childcare services; and reminder calls for convenient, flexibly scheduled appointments. Analyses reported here: 1) compare recruitment projections to actual enrollment 2) explore recruitment bias; 3) validate the randomization process 4) document the extent to which contact was maintained and complete assessments achieved 5) determine if follow-up was conditioned upon socio-economic status, race/ethnicity, or other factors.

Results: Of eligible women approached, 1,126 (77.7%) agreed to participate fully. Of the 324 not agreeing, 118 (36.4%) completed a short survey. Consenting women were disproportionately from minority and low SES backgrounds: 71.5% consenting were African American, versus 38.8% not consenting. Consenting women were also more likely to report homelessness during their lifetime (14.6% vs. 0.87%) and to be unmarried at the time of delivery (81.6% versus 47.9%). First one-month postpartum assessment was completed for 83.5% (n = 472) of the intervention group (n = 565) and 76% (426) of the control group. Higher assessment completion rates were observed for the intervention group throughout the follow-up. Second, third, fourth and fifth postpartum assessments were 67.6% vs. 57.5%, 60.0% vs. 48.9%, 54.2% vs. 46.3% and 47.3% vs. 40.8%, for the intervention and control group women, respectively. There were no differences in follow-up rates according to race/ethnicity, SES or other factors. Greater retention of the intervention group may reflect the highly-valued nature of the medical and behavior services constituting the intervention arms of the Project.

Conclusion: Findings challenge beliefs that low income and minority women are averse to enrolling and continuing in clinical trials or community studies.

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Related in: MedlinePlus

Flow Chart of Study Sample
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Figure 2: Flow Chart of Study Sample

Mentions: As Figure 2 shows 2,243 women were approached and asked to participate in the study and 1,450 women (64.6%) were eligible. Of the eligible women 1,126 (77.7%) agreed to participate fully. Of the 324 who did not agree, 118 (36.4%) permitted us to administer the short-form survey described above. Of the women who agreed to participate fully in the study (n = 1,126), 561 women were randomized into the usual care and 565 women were randomized into the intervention groups.


Recruitment and retention of women in a large randomized control trial to reduce repeat preterm births: the Philadelphia Collaborative Preterm Prevention Project.

Webb DA, Coyne JC, Goldenberg RL, Hogan VK, Elo IT, Bloch JR, Mathew L, Bennett IM, Dennis EF, Culhane JF - BMC Med Res Methodol (2010)

Flow Chart of Study Sample
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2957387&req=5

Figure 2: Flow Chart of Study Sample
Mentions: As Figure 2 shows 2,243 women were approached and asked to participate in the study and 1,450 women (64.6%) were eligible. Of the eligible women 1,126 (77.7%) agreed to participate fully. Of the 324 who did not agree, 118 (36.4%) permitted us to administer the short-form survey described above. Of the women who agreed to participate fully in the study (n = 1,126), 561 women were randomized into the usual care and 565 women were randomized into the intervention groups.

Bottom Line: Consenting women were disproportionately from minority and low SES backgrounds: 71.5% consenting were African American, versus 38.8% not consenting.There were no differences in follow-up rates according to race/ethnicity, SES or other factors.Greater retention of the intervention group may reflect the highly-valued nature of the medical and behavior services constituting the intervention arms of the Project.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Adolescent Medicine, Children's Hospital of Philadelphia, 3535 Market Street, Philadelphia, PA 19104, USA. WEBBD@email.chop.edu

ABSTRACT

Background: Recruitment and retention of patients for randomized control trial (RCT) studies can provide formidable challenges, particularly with minority and underserved populations. Data are reported for the Philadelphia Collaborative Preterm Prevention Project (PCPPP), a large RCT targeting risk factors for repeat preterm births among women who previously delivered premature (< 35 weeks gestation) infants.

Methods: Design of the PCPPP incorporated strategies to maximize recruitment and retention. These included an advanced database system tracking follow-up status and assessment completion rates; cultural sensitivity training for staff; communication to the community and eligible women of the benefits of participation; financial incentives; assistance with transportation and supervised childcare services; and reminder calls for convenient, flexibly scheduled appointments. Analyses reported here: 1) compare recruitment projections to actual enrollment 2) explore recruitment bias; 3) validate the randomization process 4) document the extent to which contact was maintained and complete assessments achieved 5) determine if follow-up was conditioned upon socio-economic status, race/ethnicity, or other factors.

Results: Of eligible women approached, 1,126 (77.7%) agreed to participate fully. Of the 324 not agreeing, 118 (36.4%) completed a short survey. Consenting women were disproportionately from minority and low SES backgrounds: 71.5% consenting were African American, versus 38.8% not consenting. Consenting women were also more likely to report homelessness during their lifetime (14.6% vs. 0.87%) and to be unmarried at the time of delivery (81.6% versus 47.9%). First one-month postpartum assessment was completed for 83.5% (n = 472) of the intervention group (n = 565) and 76% (426) of the control group. Higher assessment completion rates were observed for the intervention group throughout the follow-up. Second, third, fourth and fifth postpartum assessments were 67.6% vs. 57.5%, 60.0% vs. 48.9%, 54.2% vs. 46.3% and 47.3% vs. 40.8%, for the intervention and control group women, respectively. There were no differences in follow-up rates according to race/ethnicity, SES or other factors. Greater retention of the intervention group may reflect the highly-valued nature of the medical and behavior services constituting the intervention arms of the Project.

Conclusion: Findings challenge beliefs that low income and minority women are averse to enrolling and continuing in clinical trials or community studies.

Show MeSH
Related in: MedlinePlus