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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusion</p> <p>Findings challenge beliefs that low income and minority women are averse to enrolling and continuing in clinical trials or community studies.</p

The use of Pursed Lips Breathing in stable chronic obstructive pulmonary disease: a systematic review of the evidence

Original article can be found at: http://maney.co.uk/index.php/journals/ptr/ Copyright W.S.Maney &amp; Son Ltd.Objective: A systematic review was carried out to determine the evidence for teaching pursed lips breathing (PLB) to patients with stable COPD. Exertional dyspnoea is the single most important factor limiting function for people with COPD and PLB is commonly advocated for its management. Method: A literature search of Medline, PEDro and CINAHL Plus was conducted. Articles were included if they studied the effects of PLB in stable COPD and excluded when proxy interventions or significant modifications of PLB were used. Where comparable data were available they were pooled using weighted means. Results: Eleven studies involving 226 participants were included; four of the studies were of moderate quality according to The Grading of Recommendations Assessments, Development and Evaluation (GRADE) system, with the remaining studies being of low quality. Although no high quality evidence was identified, with the exception of one low quality study, the direction of effect for PLB was consistently towards benefit. Moderate quality evidence demonstrates that in stable COPD pursed lips breathing increases oxygen saturation and tidal volume, reduces respiratory rate during use at rest and reduces time taken to recover to pre-exercise breathlessness levels; one RCT showed reduction in exertional dyspnoea and improvement in functional performance at 3 months. Additionally, the evidence suggests that not all patients with COPD respond equally to PLB, those with moderate to severe COPD being most likely to benefit. Conclusion: High quality studies are required to identify PLB responders from nonresponders and to determine whether short-term effects translate into clinically significant benefit.Peer reviewe