Evidence map›Paper›PMID 30294698›Full record

ArticleContemporary clinical trials communications2018

Two-step recruitment process optimizes retention in FLEX clinical trial.

Debra A Standiford, Nancy Morwessel, Franziska K Bishop, Joan M Thomas, Emily Smith, Jamie Crandell, Kimberly A Driscoll, Christine M Hunter, Jessica C Kichler, David M Maahs and 2 more

Erratum issuedAbstract read
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Article in Contemporary clinical trials communications, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Debra A StandifordCincinnati Children's Hospital Medical Center, University of Cincinnati Medical School, Cincinnati, OH, United States.
Nancy MorwesselCincinnati Children's Hospital Medical Center, University of Cincinnati Medical School, Cincinnati, OH, United States.
Franziska K BishopBarbara Davis Center for Childhood Diabetes, University of Colorado Denver, Aurora, CO, United States.
Joan M ThomasDepartments of Nutrition and Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
Emily SmithCincinnati Children's Hospital Medical Center, University of Cincinnati Medical School, Cincinnati, OH, United States.
Jamie CrandellSchool of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
Kimberly A DriscollBarbara Davis Center for Childhood Diabetes, University of Colorado Denver, Aurora, CO, United States.
Christine M HunterNational Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, United States.
Jessica C KichlerCincinnati Children's Hospital Medical Center, University of Cincinnati Medical School, Cincinnati, OH, United States.
David M MaahsDepartment of Pediatrics, School of Medicine, Stanford University, Stanford, CA, United States.
Elizabeth J Mayer-DavisDepartments of Nutrition and Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
Michael SeidCincinnati Children's Hospital Medical Center, University of Cincinnati Medical School, Cincinnati, OH, United States.

Funding

UNIV OF NORTH CAROLINA CLINICAL NUTRITION RESEARCH UNITP30DK056350 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Ian Michael Carroll · 1999 to 2026
$31.6M
FL3X: An Adaptive Intervention to Improve Outcomes for Youth with Type 1 DiabetesUC4DK101132 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MAAHS, DAVID MATTHEW, MAYER-DAVIS, ELIZABETH J · 2013 to 2013
$6.9M
NIDDK NIH HHS P30 DK056350NIDDK NIH HHS UC4 DK101132
6 · The paper itself

Abstract

introductionThe Flexible Lifestyle Empowering Change Study (FLEX) is a multi-site randomized controlled trial to test the efficacy of an adaptive behavioral intervention to promote self-management and improve glycemic control for adolescents with type 1 diabetes mellitus. A two-step recruitment process was used to optimize study retention by facilitating informed decision-making regarding participation.

methodsThose who expressed interest at first contact were given more detailed study information followed by telephone calls to the adolescents and their parents to answer questions and explore potential barriers to participation before making a decision regarding study enrollment.

resultsOf 694 eligible adolescents who were invited to participate, 397 (57.2%) expressed interest when initially contacted (Step 1). Upon completion of the follow-up telephone calls (Step 2), 276 (39.8%) still agreed to participate; and 258 (37.2%) enrolled and completed a baseline visit with a parent/guardian. Completion rates for measurement visits remained high throughout the study, with an end-of-study retention rate of 93.4%; and only 12 (4.7%) families withdrew from the study.

conclusionThe two-step recruitment process encourages potential participants to thoughtfully evaluate their willingness to participate, as well as their ability to make a commitment to the full completion of study requirements. When demonstrating the efficacy of a randomized controlled trial, it may be preferable to accept lower recruitment rates in order to optimize retention rates. The additional time and effort required to implement this two-step process is worthwhile. With a high retention rate, we can be more confident that the outcomes of the randomized controlled trial actually reflect the impact of the intervention.

Indexed as

AdolescentRandomized controlled trialRecruitmentRetentionType 1 diabetes

Identifiers

PMID30294698
PMCPMC6169149

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.