Data retention after a patient withdraws consent in clinical trials

Gabriel, Andre; Mercado, Charles P.

doi:10.2147/oajct.s13960

Cited by 9 publications

(12 citation statements)

References 7 publications

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“…This study further supports prior literature showing no adverse effect of progestin-only contraceptives on lactation, 20 and high levels of contraceptive satisfaction for women in both groups. 7 …”

Section: Commentsupporting

confidence: 91%

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Immediate postpartum levonorgestrel intrauterine device insertion and breast-feeding outcomes: a noninferiority randomized controlled trial

Turok

Leeman

Sanders

et al. 2017

American Journal of Obstetrics and Gynecology

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BACKGROUND Immediate postpartum levonorgestrel intrauterine device insertion is increasing in frequency in the United States, but few studies have investigated the effect of early placement on breast-feeding outcomes. OBJECTIVE This study examined the effect of immediate vs delayed postpartum levonorgestrel intrauterine device insertion on breast-feeding outcomes. STUDY DESIGN We conducted this noninferiority randomized controlled trial at the University of Utah and the University of New Mexico Health Sciences Centers from February 2014 through March 2016. Eligible women were pregnant and planned to breast-feed, spoke English or Spanish, were aged 18–40 years, and desired a levonorgestrel intrauterine device. Enrolled women were randomized 1:1 to immediate postpartum insertion or delayed insertion at 4–12 weeks’ postpartum. Prespecified exclusion criteria included delivery <37.0 weeks’ gestational age, chorioamnionitis, postpartum hemorrhage, contraindications to levonorgestrel intrauterine device insertion, and medical complications of pregnancy that could affect breast-feeding. We conducted per-protocol analysis as the primary approach, as it is considered the standard for noninferiority studies; we also report the alternative intent-to-treat analysis. We powered the study for the primary outcome, breast-feeding continuation at 8 weeks, to detect a 15% noninferiority margin between groups, requiring 132 participants in each arm. The secondary study outcome, time to lactogenesis, used a validated measure, and was analyzed by survival analysis and log rank test. We followed up participants for ongoing data collection for 6 months. Only the data analysis team was blinded to the intervention. RESULTS We met the enrollment target with 319 participants, but lost 34 prior to randomization and excluded an additional 26 for medical complications prior to delivery. The final analytic sample included 132 in the immediate group and 127 in the delayed group. Report of any breast-feeding at 8 weeks in the immediate group (79%; 95% confidence interval, 70–86%) was noninferior to that of the delayed group (84%; 95% confidence interval, 76–91%). The 5% difference in breast-feeding continuation at 8 weeks between the groups fell within the noninferiority margin (95% confidence interval, −5.6 to 15%). Time to lactogenesis (mean ± SD) in the immediate group, 65.3 ± 25.7 hours, was noninferior to that of the delayed group, 63.6 ± 21.6 hours. The mean difference between groups was 1.7 hours (95% confidence interval, −4.8 to 8.2 hours), noninferior by log-rank test. A total of 24 intrauterine device expulsions occurred in the immediate group compared to 2 in the delayed group (19% vs 2%, P < .001), consistent with the known higher expulsion rate with immediate vs delayed postpartum intrauterine device insertion. No intrauterine device perforations occurred in either group. CONCLUSION Our results of noninferior breast-feeding outcomes between women with immediate and delayed postpartum levonorgestrel intrauterine device inse...

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Section: Commentsupporting

confidence: 91%

“…Postrandomization exclusion criteria for per-protocol analysis included protocol violations and participant withdrawals prior to hospital discharge. We retained data for women in the delayed insertion group who were lost to follow-up or withdrew from the study after primary outcome data were collected 20 (Figure 1). …”

Section: Resultsmentioning

confidence: 99%

Immediate postpartum levonorgestrel intrauterine device insertion and breast-feeding outcomes: a noninferiority randomized controlled trial

Turok

Leeman

Sanders

et al. 2017

American Journal of Obstetrics and Gynecology

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“…This national refusal rate is similar to that seen on other COG ALL frontline trials with postinduction randomization/treatment assignments 19,20 . Potential adverse impacts of study withdrawal are selection bias, wasted resources and time, and longer time to trial completion 21–23 …”

Section: Introductionsupporting

confidence: 64%

Parental decision making regarding consent to randomization on Children's Oncology Group AALL0932

Parker

Cottrell

Stork

et al. 2021

Pediatric Blood & Cancer

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Background Within pediatric oncology, parental decision making regarding participation in clinical trials that aim to reduce therapy to mitigate side effects is not well studied. The recently completed Children's Oncology Group trial for standard‐risk acute lymphoblastic leukemia (AALL0932) included a reduction in maintenance therapy, and required consent for randomization immediately prior to starting maintenance. At our institution, 40% of children enrolled on AALL0932 were withdrawn from protocol therapy prior to randomization due to parental choice. This study sought to identify factors that impacted parental decision making regarding randomization on AALL0932. Procedure Parents of children enrolled on AALL0932 at our institution were eligible if their child met criteria for the average‐risk randomization. Parents were invited to participate in a 30‐50‐minute phone interview. Questions focused on factors that shaped parental decision making about randomization, as well as their perspectives about the clinical trial experience more generally. Results Fear of receiving less therapy and subsequent relapse was the predominant reason to decline randomization. Reasons given for consenting to randomization included trust in the physician, altruism, hope for less therapy, and potential for fewer side effects. Parents also reflected on ways to support future families making decisions about clinical trial participation. Conclusion While many parents recognize the importance of clinical trials aiming to mitigate side effects, the fear of their own child relapsing with less than standard therapy may dissuade them from study participation. Recognizing and addressing these concerns will be important for enrollment and retention in future clinical trials.

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“…While we have not experienced active study withdrawl up to the time of this publication, a crucial component to the planning phase is a clear understanding of procedures that follow study dropout or voluntary withdrawal of consent. We sought guidance from the Office for Human Research Protections on this, and have integrated their recommendations and good clinical practice (GCP) guidelines into our protocol (Gabriel & Mercado, 2011; United States Department of Health and Human Services, 2017). The following guidelines are consistent with the 2017 changes to the final Common Rule governing research with human subjects (Agency for International Development, 2017).…”

Section: Methodsmentioning

confidence: 99%

Creation of Data Repositories to Advance Nursing Science

et al. 2017

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Data repositories are a strategy in line with precision medicine and big data initiatives, and are an efficient way to maximize data utility and form collaborative research relationships. Nurse researchers are uniquely positioned to make a valuable contribution using this strategy. The purpose of this article is to present a review of the benefits and challenges associated with developing data repositories, and to describe the process we used to develop and maintain a data repository in HIV research. Systematic planning, data collection, synthesis, and data sharing have enabled us to conduct robust cross-sectional and longitudinal analyses with more than 200 people living with HIV. Our repository building has also led to collaboration and training, both in and out of our organization. We present a pragmatic and affordable way that nurse scientists can build and maintain a data repository, helping us continue to make to our understanding of health phenomena.

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Data retention after a patient withdraws consent in clinical trials

Cited by 9 publications

References 7 publications

Immediate postpartum levonorgestrel intrauterine device insertion and breast-feeding outcomes: a noninferiority randomized controlled trial

Immediate postpartum levonorgestrel intrauterine device insertion and breast-feeding outcomes: a noninferiority randomized controlled trial

Parental decision making regarding consent to randomization on Children's Oncology Group AALL0932

Creation of Data Repositories to Advance Nursing Science

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