Recruitment, retention, and adherence in a clinical trial: The Pediatric Heart Network’s Marfan Trial experience

Background/Aims: The Pediatric Heart Network Marfan Trial was a randomized trial comparing atenolol versus losartan on aortic root dilation in 608 children and young adults with Marfan syndrome. Barriers to enrollment included a limited pool of eligible participants, restrictive entry criteria, and a diverse age range that required pediatric and adult expertise. Retention was complicated by a 3-year commitment to a complex study and medication regimen. The Network partnered with the Marfan Foundation, bridging the community with the research. The aims of this study are to report protocol and medication adherence and associated predictive factors, and to describe recruitment and retention strategies. Methods: Recruitment, retention, and adherence to protocol activities related to the primary outcome were measured. Retention was measured by percentage of enrolled participants with 3-year outcome data. Protocol adherence was calculated by completion rates of study visits, ambulatory electrocardiography (Holter monitoring), and quarterly calls. Medication adherence was assessed by the number of tablets or the amount of liquid in bottles returned. Centers were ranked according to adherence (high, medium, and low tertiles). Recruitment, retention, and adherence questionnaires were completed by sites. Descriptive statistics summarized recruitment, retention, and adherence, as well as questionnaire results. Regression modeling assessed predictors of adherence. Results: Completion rates for visits, Holter monitors, and quarterly calls were 99%, 94%, and 96%, respectively. Primary outcome data at 3 years were obtained for 88% of participants. The mean percentage of medication taken was estimated at 89%. Site and age were associated with all measures of adherence. Young adult and African American participants had lower levels of adherence. Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation’s resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence. Conclusion: Overall adherence was excellent for this trial conducted within a National Institutes of Health–funded clinical trial network. Strategies specifically targeted to young adults and African Americans may have been beneficial. Many strategies employed by higher adherence sites are ones that any site could easily use, such as greeting families at non-study hospital visits, asking for family feedback, providing calendars for tracking schedules, and recommending apps for medication reminders. Additional key learnings include adherence differences by age, race, and site, the value of collaborative learning, and the importance of partnerships with patient advocacy groups. These lessons could shape recruitment, retention, and adherence to improve the quality of future complex trials involving rare conditions.

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Effect of telephone calls from a centralized coordinating center on participant retention in a randomized clinical trial

Clinical Trials ◽

10.1177/1740774519894229 ◽

2020 ◽

Vol 17 (2) ◽

pp. 195-201

Author(s):

Adam R Glassman ◽

Wesley T Beaulieu ◽

Cynthia R Stockdale ◽

Roy W Beck ◽

Neil M Bressler ◽

...

Keyword(s):

Clinical Trial ◽

Confidence Interval ◽

Risk Ratio ◽

Primary Outcome ◽

Completion Rates ◽

Contact Group ◽

Phone Calls ◽

Participant Retention ◽

To Receive

Background/Aims: In clinical trials, participant retention is critical to reduce bias and maintain statistical power for hypothesis testing. Within a multi-center clinical trial of diabetic retinopathy, we investigated whether regular phone calls to participants from the coordinating center improved long-term participant retention. Methods: Among 305 adults in the Diabetic Retinopathy Clinical Research Retina Network Protocol S randomized trial, 152 participants were randomly assigned to receive phone calls at baseline, 6 months, and annually through 3 years (annual contact group) while 153 participants were assigned to receive a phone call at baseline only (baseline contact group). All participants could be contacted if visits were missed. The main outcomes were visit completion, excluding deaths, at 2 years (the primary outcome time point) and at 5 years (the final time point). Results: At baseline, 77% (117 of 152) of participants in the annual contact group and 76% (116 of 153) in the baseline contact group were successfully contacted. Among participants in the annual contact group active at each annual visit (i.e. not dropped from the study or deceased), 85% (125 of 147), 79% (108 of 136), and 88% (110 of 125) were contacted successfully by telephone around the time of the 1-, 2-, and 3-year visits, respectively. In the annual and baseline contact groups, completion rates for the 2-year primary outcome visit were 88% (129 of 147) versus 87% (125 of 144), respectively, with a risk ratio of 1.01 (95% confidence interval: 0.93–1.10, p = .81). At 5 years, the final study visit, participant completion rates were 67% (96 of 144) versus 66% (88 of 133) with a risk ratio of 1.01 (95% confidence interval = 0.85–1.19, p = .93). At 2 years, the completion rate of participants successfully contacted at baseline was 89% (202 of 226) versus 80% (52 of 65) among those not contacted successfully (risk ratio = 1.12, 95% confidence interval = 0.98–1.27, p = .09); at 5 years, the completion percentages by baseline contact success were 69% (148 of 213) versus 56% (36 of 64; risk ratio = 1.24, 95% confidence interval = 0.98–1.56, p = .08). Conclusion: Regular phone calls from the coordinating center to participants during follow-up in this randomized clinical trial did not improve long-term participant retention.

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Supplemental Material for Who Responds Best to Text-Delivered Cannabis Use Disorder Treatment? A Randomized Clinical Trial With Young Adults

Psychology of Addictive Behaviors ◽

10.1037/adb0000403.supp ◽

2018 ◽

Keyword(s):

Clinical Trial ◽

Young Adults ◽

Randomized Clinical Trial ◽

Cannabis Use ◽

Cannabis Use Disorder ◽

Disorder Treatment

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A Prospective Multicenter Clinical Trial of MRD-based Treatment Strategy in Children and Young Adults With AML

Case Medical Research ◽

10.31525/ct1-nct03846362 ◽

2000 ◽

Author(s):

Keyword(s):

Clinical Trial ◽

Young Adults ◽

Treatment Strategy ◽

Multicenter Clinical Trial ◽

Children And Young Adults

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Faculty Opinions recommendation of Antiretroviral medication adherence and class- specific resistance in a large prospective clinical trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.3057960.2739058 ◽

2010 ◽

Author(s):

Caroline Sabin

Keyword(s):

Clinical Trial ◽

Medication Adherence ◽

Specific Resistance ◽

Prospective Clinical Trial ◽

Antiretroviral Medication ◽

Antiretroviral Medication Adherence

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Faculty Opinions recommendation of Effect of continuous glucose monitoring on glycemic control in adolescents and young adults with type 1 diabetes: A randomized clinical trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.738151941.793576584 ◽

2020 ◽

Author(s):

Helmy Siragy

Keyword(s):

Clinical Trial ◽

Type 1 Diabetes ◽

Young Adults ◽

Glycemic Control ◽

Randomized Clinical Trial ◽

Continuous Glucose Monitoring ◽

Glucose Monitoring ◽

Adolescents And Young Adults

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The Australian Youth Cancer Service: Developing and Monitoring the Activity of Nationally Coordinated Adolescent and Young Adult Cancer Care

Cancers ◽

10.3390/cancers13112675 ◽

2021 ◽

Vol 13 (11) ◽

pp. 2675

Author(s):

Pandora Patterson ◽

Kimberley R. Allison ◽

Helen Bibby ◽

Kate Thompson ◽

Jeremy Lewin ◽

...

Keyword(s):

Clinical Trial ◽

Young Adults ◽

Cancer Care ◽

Young Patients ◽

Adolescents And Young Adults ◽

Adolescent And Young Adult ◽

Trial Participation ◽

Clinical Trial Participation ◽

Activity Data ◽

Cancer Services

Adolescents and young adults (aged 15–25 years) diagnosed with cancer have unique medical and psychosocial experiences and care needs, distinct from those of paediatric and older adult patients. Since 2011, the Australian Youth Cancer Services have provided developmentally appropriate, multidisciplinary and comprehensive care to these young patients, facilitated by national service coordination and activity data collection and monitoring. This paper reports on how the Youth Cancer Services have conceptualised and delivered quality youth cancer care in four priority areas: clinical trial participation, oncofertility, psychosocial care and survivorship. National activity data collected by the Youth Cancer Services between 2016–17 and 2019–20 are used to illustrate how service monitoring processes have facilitated improvements in coordination and accountability across multiple indicators of quality youth cancer care, including clinical trial participation, access to fertility information and preservation, psychosocial screening and care and the transition from active treatment to survivorship. Accounts of both service delivery and monitoring and evaluation processes within the Australian Youth Cancer Services provide an exemplar of how coordinated initiatives may be employed to deliver, monitor and improve quality cancer care for adolescents and young adults.

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