Recruiting pregnant smokers into a clinical trial: Using a network-model managed care organization versus community-based practices

Park, Elyse R.; Quinn, Virginia P.; Chang, Yuchiao; Regan, Susan; Loudin, Beverly; Cummins, Sharon E.; Perry, Kristin J.; Rigotti, Nancy A.

doi:10.1016/j.ypmed.2006.10.008

Cited by 22 publications

(18 citation statements)

References 22 publications

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“…Recruiting pregnant women into smoking cessation trials is both resource intensive and time-consuming. 51 Therefore, retaining participants and maximizing adherence to scheduled sessions becomes paramount.…”

Section: Discussionmentioning

confidence: 99%

Predictors of Smoking Cessation Counseling Adherence in a Socioeconomically Disadvantaged Sample of Pregnant Women

Wen¹,

Miller²,

Lazev³

et al. 2012

hpu

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Implementing and evaluating smoking cessation interventions in underserved populations has been found difficult due to high rates of non-adherence to the prescribed protocol. To understand better the barriers to cessation participation, we studied low-income inner-city pregnant women who were enrolled in either a standard or highly intensive quit smoking counseling program. The results showed that 1) in the prenatal phase, non-attendance was predicted by a greater number of cigarettes smoked per day; 2) in the postpartum follow-up phase, non-attendance was predicted by lower educational level and higher self-efficacy for quitting smoking; and 3) participants with more children living at home were at increased risk of rescheduling the postpartum follow-up session. These findings suggest that innovative delivery strategies are needed more effectively to assess and address risk factors for non-adherence to smoking cessation trials among underserved minority pregnant/postpartum smokers.

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Section: Discussionmentioning

confidence: 99%

Predictors of Smoking Cessation Counseling Adherence in a Socioeconomically Disadvantaged Sample of Pregnant Women

Wen¹,

Miller²,

Lazev³

et al. 2012

hpu

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“…Recruitment and retention of low-income urban residents is particularly challenging and may be complicated by lack of time, transportation, and child care; inflexible work schedules; unstable housing and unsafe neighborhood conditions; chaotic lives; and distrust of medical institutions and research (2). Studies with narrow eligibility criteria (3) or complex protocols face additional obstacles (4). Adequate sample recruitment is essential to conduct high-quality studies.…”

Section: Introductionmentioning

confidence: 99%

Recruitment and Retention of Pregnant Women for a Behavioral Intervention: Lessons from the Maternal Adiposity, Metabolism, and Stress (MAMAS) Study

Coleman‐Phox¹,

Laraia²,

Adler³

et al. 2013

Prev. Chronic Dis.

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IntroductionRecruiting participants for research studies can be challenging. Many studies fall short of their target or must prolong recruitment to reach it. We examined recruitment and retention strategies and report lessons learned in a behavioral intervention developmental trial to encourage healthy pregnancy weight gain and stress reduction in low-income overweight pregnant women.MethodsIn the San Francisco Bay area from February 2010 through March 2011, we used direct and indirect strategies to recruit English-speaking overweight and obese pregnant women who were aged 18 to 45, were in the early stages of pregnancy, and who had an annual household income less than 500% of the federal poverty guidelines. Eligible women who consented participated in focus groups or an 8-week behavioral intervention. We identified successful recruiting strategies and sites and calculated the percentage of women who were enrolled and retained.ResultsOf 127 women screened for focus group participation, 69 were eligible and enrolled. A total of 57 women participated in 9 focus groups and 3 women completed individual interviews for a completion rate of 87%. During recruitment for the intervention, we made contact with 204 women; 135 were screened, 33% were eligible, and 69.1% of eligible women enrolled. At 1 month postpartum, 82.6% of eligible women completed an assessment. Recruiting at hospital-based prenatal clinics was the highest-yielding strategy.ConclusionThe narrow window of eligibility for enrolling early stage pregnant women in a group intervention presents obstacles. In-person recruitment was the most successful strategy; establishing close relationships with providers, clinic staff, social service providers, and study participants was essential to successful recruitment and retention.

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“…However, the disadvantaged are disproportionately hard to reach [13], [21]. To safeguard investment in clinical trials, the research community should budget sufficient time and resources for complicated, personalised contact and follow up procedures [18], [28], as in birth cohorts [25], [63].…”

Section: Discussionmentioning

confidence: 99%

Volunteer Bias in Recruitment, Retention, and Blood Sample Donation in a Randomised Controlled Trial Involving Mothers and Their Children at Six Months and Two Years: A Longitudinal Analysis

et al. 2013

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BackgroundThe vulnerability of clinical trials to volunteer bias is under-reported. Volunteer bias is systematic error due to differences between those who choose to participate in studies and those who do not.Methods and ResultsThis paper extends the applications of the concept of volunteer bias by using data from a trial of probiotic supplementation for childhood atopy in healthy dyads to explore 1) differences between a) trial participants and aggregated data from publicly available databases b) participants and non-participants as the trial progressed 2) impact on trial findings of weighting data according to deprivation (Townsend) fifths in the sample and target populations. 1) a) Recruits (n = 454) were less deprived than the target population, matched for area of residence and delivery dates (n = 6,893) (mean [SD] deprivation scores 0.09[4.21] and 0.79[4.08], t = 3.44, df = 511, p<0.001). b) i)As the trial progressed, representation of the most deprived decreased. These participants and smokers were less likely to be retained at 6 months (n = 430[95%]) (OR 0.29,0.13–0.67 and 0.20,0.09–0.46), and 2 years (n = 380[84%]) (aOR 0.68,0.50–0.93 and 0.55,0.28–1.09), and consent to infant blood sample donation (n = 220[48%]) (aOR 0.72,0.57–0.92 and 0.43,0.22–0.83). ii)Mothers interested in probiotics or research or reporting infants’ adverse events or rashes were more likely to attend research clinics and consent to skin-prick testing. Mothers participating to help children were more likely to consent to infant blood sample donation. 2) In one trial outcome, atopic eczema, the intervention had a positive effect only in the over-represented, least deprived group. Here, data weighting attenuated risk reduction from 6.9%(0.9–13.1%) to 4.6%(−1.4–+10.5%), and OR from 0.40(0.18–0.91) to 0.56(0.26–1.21). Other findings were unchanged.ConclusionsPotential for volunteer bias intensified during the trial, due to non-participation of the most deprived and smokers. However, these were not the only predictors of non-participation. Data weighting quantified volunteer bias and modified one important trial outcome.Trial RegistrationThis randomised, double blind, parallel group, placebo controlled trial is registered with the International Standard Randomised Controlled Trials Register, Number (ISRCTN) 26287422. Registered title: Probiotics in the prevention of atopy in infants and children.

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Recruiting pregnant smokers into a clinical trial: Using a network-model managed care organization versus community-based practices

Cited by 22 publications

References 22 publications

Predictors of Smoking Cessation Counseling Adherence in a Socioeconomically Disadvantaged Sample of Pregnant Women

Predictors of Smoking Cessation Counseling Adherence in a Socioeconomically Disadvantaged Sample of Pregnant Women

Recruitment and Retention of Pregnant Women for a Behavioral Intervention: Lessons from the Maternal Adiposity, Metabolism, and Stress (MAMAS) Study

Volunteer Bias in Recruitment, Retention, and Blood Sample Donation in a Randomised Controlled Trial Involving Mothers and Their Children at Six Months and Two Years: A Longitudinal Analysis

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