Recruitment of Black Adults into Cardiovascular Disease Trials

Background Although disproportionately affected by cardiovascular disease, Black adults remain underrepresented in clinical trials. The National Institutes of Health recommends that studies define goals for recruitment of underrepresented populations. However, the extent to which cardiovascular trials incorporate evidence‐based recruitment strategies in their protocols is understudied. Methods and Results We systematically reviewed National Institutes of Health‐funded cardiovascular clinical trials registered in ClinicalTrials.gov between 2000 and 2019. Based on publicly available or requested protocols, we focused on enrollment of Black adults as well as the following recruitment strategies: community‐based, electronic medical record‐based, and provider‐based recruitment. A total of 100 clinical trials focused on cardiovascular disease were included in our analysis, of which 62% had published protocols, and 46% of trials had enrolled populations that were <25% Black. In our analysis of available trial protocols, 21% of trials defined a recruitment target for underrepresented groups; however, only one study reported achieving its enrollment goal. While 13% of trial protocols referenced community‐based recruitment strategies, 5% explicitly mentioned involving community members in the trial design process. Defining recruitment targets was associated with higher enrollment of Black participants. Conclusions Black adults are underrepresented in National Institutes of Health‐funded cardiovascular trials, and the majority of these trials did not specify a Black enrollment target, did not meet targets, and largely did not report specific plans to enroll Black adults in their studies. Future interventions should target trial design and planning phases before study initiation to address these enrollment disparities.

Advancing Academic Cancer Clinical Trials Recruitment in Canada

The Canadian Cancer Clinical Trials Network (3CTN) was established in 2014 to address the decline in academic cancer clinical trials (ACCT) activity. Funding was provided to cancer centres to conduct a Portfolio of ACCTs. Larger centres received core funding and were paired with smaller centres to enable support and sharing of resources. All centres were eligible for incentive-based funding for recruitment above pre-3CTN baseline. Established performance measures were collected and tracked. The overall recruitment target was 50% above pre-3CTN baseline by Year 4. An analysis was completed to identify predictive success factors and descriptive statistics were used to summarize site characteristics and outcomes. From 2014–2018, a total of 11,275 patients were recruited to 559 Portfolio trials, an overall increase of 59.6% above pre-3CTN baseline was observed in Year 4. Twenty-five (51%) adult centres met the Year 4 recruitment target and the overall recruitment target was met within three years. Three factors that correlated with sites’ achieving recruitment targets were: time period, region and number of baseline trials. 3CTN was successful in meeting its objectives and will continue to support ACCTs and member cancer centres, monitor performance over time and seek continued funding to ensure success, better trial access and outcomes for patients.

Barriers to recruiting and retaining psychosis carers: a case study on the lessons learned from the Caring for Caregivers (C4C) trial

Objective Carers play an important role within the UK mental health system. Those carers who support persons with psychosis can experience a reduction in their own physical and mental health. As part of the Caring for Caregivers (C4C) trial, we piloted a writing intervention (Positive Written Disclosure) that has been shown to improve wellbeing in other populations. Although we reached our recruitment target, we encountered several barriers that made recruitment slower than anticipated. This paper synthesises the process data collected during the C4C trial that relates to the barriers to recruiting and retaining psychosis carers. Results We encountered four main carer-specific barriers to the recruitment and retention of participants in our study. These were: (1) poor relationship with mental health clinicians, (2) conflicting with the care recipient’s (CR) needs, (3) lack of spare time, and (4) lack of services for mental health carers. The interventions to assist carers need to be informed by robust evidence and this requires trials that reach their recruitment targets. By sharing our practical experiences other researchers and clinicians can modify their practices to minimise recruitment difficulties and delay. Trial registration ISRCTN79116352. Retrospectively registered (before the final participant was recruited) on 23rd January 2017

Design, planning and implementation lessons learnt from a surgical multi-centre randomised controlled trial

Background Increasingly, pragmatic randomised controlled trials are being used to evaluate surgical interventions, although they present particular difficulties in regards to recruitment and retention. Methods Procedures and processes related to implementation of a multi-centre pragmatic surgical randomised controlled trial are discussed. In this surgical trial, forecasting of consent rates based on similar trials and micro-costing of study activities with research partners were undertaken and a video was produced targeting recruiting staff with the aim of aiding recruitment. The baseline assessments were reviewed to ensure the timing did not impact on the outcome. Attrition due to procedure waiting time was monitored and data were triangulated for the primary outcome to ensure adequate follow-up data. Results Forecasting and costing ensured that the recruitment window was of adequate length and adequate resource was available for study procedures at multiple clinics in each hospital. Recruiting staff found the recruitment video useful. The comparison of patient-reported data collected prior to randomisation and prior to treatment provided confidence in the baseline data. Knowledge of participant dropout due to delays in treatment meant we were able to increase the recruitment target in a timely fashion, and along with the triangulation of data sources, this ensured adequate follow-up of randomised participants. Conclusions This paper provides a range of evidence-based and experience-based approaches which, collectively, resulted in meeting our study objectives and from which lessons may be transferable. Trial registration ISRCTN, ISRCTN41394716. Registered on 10 May 2012. UKCRN Study ID: 12486.

General practice referral of ‘at risk’ populations to community leisure services: applying the RE-AIM framework to evaluate the impact of a community-based physical activity programme for inactive adults with long-term conditions

Background In the UK a high proportion of adults with long-term conditions do not engage in regular physical activity. General practice (GP) referral to community-based physical activity is one strategy that has gained traction in recent years. However, evidence for the real-world effectiveness and translation of such programmes is limited. This study aimed to evaluate the individual and organisational impacts of the ‘CLICK into Activity’ programme - GP referral of inactive adults living with (or at risk of) long-term conditions to community-based physical activity. Methods A mixed methods evaluation using the RE-AIM framework was conducted with data obtained from a range of sources: follow-up questionnaires, qualitative interviews, and programme-related documentation, including programme cost data. Triangulation methods were used to analyse data, with findings synthesised across each dimension of the RE-AIM framework. Results A total of 602 individuals were referred to CLICK into Activity physical activity sessions. Of those referred, 326 individuals participated in at least one session; the programme therefore reached 30.2% of the 1080 recruitment target. A range of individual-, social-, and environmental-level factors contributed to initial physical activity participation. Positive changes over time in physical activity and other outcomes assessed were observed among participants. Programme adoption at GP surgeries was successful, but the GP referral process was not consistently implemented across sites. Physical activity sessions were successfully implemented, with programme deliverers and group-based delivery identified as having an influential effect on programme outcomes. Changes to physical activity session content were made in response to participant feedback. CLICK into Activity cost £175,000 over 3 years, with an average cost per person attending at least one programme session of £535. Conclusions Despite not reaching its recruitment target, CLICK into Activity was successfully adopted. Positive outcomes were associated with participation, although low 6- and 12-month follow-up response rates limit understanding of longer-term programme effects. Contextual and individual factors, which may facilitate successful implementation with the target population, were identified. Findings highlight strategies to be explored in future development and implementation of GP referral to community-based physical activity programmes targeting inactive adults living with (or at risk of) long-term conditions.

Mindful fellows: Study results from a pilot wellness curriculum in hematology oncology.

10508 Background: Rates of physician burnout, depression, and career dissatisfaction are rising. It is imperative to develop solutions. Studies find mindfulness is an effective therapeutic means for physician burnout, but few programs address this in clinical trainees, specifically hematology oncology fellows. The aims of this pilot study were to determine the feasibility and acceptability of a mindfulness-based wellness curriculum. To our knowledge, this is the first study assessing this type of intervention in this population. Methods: In this single center, nonrandomized study, six monthly 30-45 minute sessions were integrated within the framework of existing didactic conferences. Each session had two parts – didactics on mindfulness and guided meditation exercises. Sessions were led by a social worker trained in mindfulness techniques. Participants completed pre and post intervention questionnaires, including Mindfulness Attention Awareness Scale (MAAS) (Carlson, 2005), Perceived Stress Scale (PSS) (Cohen, 1983), and reflection questions, with an opportunity for free responses. The primary endpoint was feasibility as determined through recruitment (target 70%) and treatment adherence defined as participation and questionnaire completion (target 80%). A secondary aim was acceptability determined through self-reflection questions (target 80%). Results: A total of 27 participants (59% female) enrolled with 37% in post-graduate year 6 (PGY-6). Of the eligible fellows, 96% enrolled and 96% of participants completed questionnaires. On self-reflection questions, 65% reported that the program was useful and 81% reported they would participate again in the future. Participants suggested modifications including location, timing, and a broader scope to include skills in addition to mindfulness (e.g. resiliency-focused). Data on self-reported levels of stress and self-awareness, an exploratory aim, will be presented at the meeting. Conclusions: Findings indicate that a mindfulness-based wellness curriculum was both feasible and acceptable for hematology oncology fellows. Modifications are being made to expand on this program, and incorporate it as a recurring component of the existing curriculum.

Consent and recruitment: the reporting of paediatric trials published in 2012

ObjectivesWe evaluated 300 paediatric trials to determine: the consent and recruitment strategies used, who trial information was targeted to, how incentives were used and if they achieved their recruitment targets.MethodsFor this cross-sectional evaluation, we searched the Cochrane Central Register of Controlled Trials for paediatric trials published in 2012 and randomly selected 300 that reported on outcomes for participants aged ≤21 years. We collected data on consent and recruitment procedures for each trial and undertook descriptive analyses in SPSS statistics V.23.ResultsAll but one trial (99.7%) used a standard recruitment strategy. Most (92%) trials reported that consent was obtained but only 13% reported who obtained consent. Two-thirds (65%) of trials included school-aged participants, and of these 68% reported obtaining assent. Half (50%) of the trials reported who the trial information was targeted to. Most trials (75%) of school-aged participants targeted information towards children or children and their parents. Fourteen per cent of trials reported using incentives, half (50%) of which were in the form of compensation. Only 48% of trials reported sufficient data to determine if their recruitment targets were achieved. Of these, 70% achieved their targets.ConclusionsNotable reporting shortcomings included: how families were recruited into the trial, who obtained consent and/or assent and how, who trial information was directed to, whether incentives were used and sufficient data to determine if the recruitment target was achieved. Forthcoming paediatric-specific reporting standards may improve reporting in this priority area. Our data provide a baseline for ongoing monitoring of the state of the research.

Racialised numerics1

This chapter focuses on the Black and Minority Ethnic (BME) recruitment target. The BME target illustrates the policy and political manoeuvring around one of William Macpherson's key recommendations: to increase the proportion of BME police officers. An important basis for increasing the proportion of BME groups in the police is due to pressure on public policy bodies to be more inclusive and representative. This is wider than race and includes gender representation and, commonly, it is based on the proportion in a local population or nationally. The acceptance, denial, and termination of this 10-year policy target underscores the extent of ‘game playing’ with numbers/targets, but it also signals the ways in which the dynamics of race and racism are like a bubble that, when suppressed in one place, ‘pops up’ in another.