Study Enrollment Rates Research Articles

Impact of an Oncology Clinical Pharmacist Intervention on Clinical Trial Enrollment in The US Oncology Network’s MYLUNG Consortium

Introduction: The Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium™ (MYLUNG) clinical trial platform aims to advance the use of precision medicine in patients with non–small cell lung cancer through a series of prospective and iterative clinical trials. Timely patient accrual onto oncology clinical trials is a known practice challenge and impaired accrual rates can lead to premature trial closure or properly powered trial outcomes. The US Oncology Network recently implemented a clinical pharmacist (ClinReview) initiative to provide remote clinical services to screen patients for enrollment onto MYLUNG Protocol 2. This study aims to evaluate the effect of the remote clinical pharmacist intervention on study enrollment rates. Methods: An oncology-trained clinical pharmacist remotely reviewed systemic chemotherapy treatment orders during normal workflow and, in addition, a weekly custom recruitment report within six community Network practices (149 physicians). The pharmacist identified, screened, and assisted with the communication regarding eligible patients for enrollment. The onsite research team received timely and relevant patient data to facilitate expedited enrollment. Enrollment and intervention data were tracked to monitor the impact of the pharmacist intervention. Monthly enrollment was evaluated using a paired t-test. Results: Over 8 months, the pharmacist screened 506 potentially eligible patients; 34% were enrolled. Average monthly enrollment was significantly greater following the ClinReview intervention (3.4 vs. 6.6 patients/month; p = .02). Among the 289 patients not enrolled, 73% exceeded their eligibility window, 9% died or enrolled into hospice, 4% declined participation, and 13% transferred care or were treated at outside facilities. Conclusions: Incorporating an oncology clinical pharmacist into the clinical research team was associated with improved clinical trial enrollment. Validation of the effect of multidisciplinary interventions across a broader spectrum of differentially resourced oncology practices will be conducted within future MYLUNG iterations.

An initial investigation of using smartphone-enabled micro-temporal data collection to increase acceptability, feasibility, and validity of research on cancer caregiving.

Smartphone-enabled micro-temporal data collection has potential to increase reliability, validity, and feasibility of participant-reported data and is a promising strategy for pediatric oncology supportive care and quality-of-life research. Given the demands of pediatric cancer caregiving, we sought to understand the feasibility and acceptability of smartphone data collection that included short surveys administered daily for 14days via text message link. We recruited pediatric cancer caregivers, whose children (ages 0-18years) were on active treatment, to complete a 14-day daily survey study via smartphone. We implemented our study procedures and examined feasibility through study enrollment rates, reasons for refusal, retention rates, number of reminders and number of completed surveys. We examined acceptability using caregiver ratings of survey length, burden, and ease of completion on a smartphone. We recruited (N=75) caregivers to the study and had an 84% enrollment rate. Reasons for declining participation included passive refusal (n=13) and too busy (n=1). The participant retention rate was 100% and compliance with daily survey completion was 99%. Most surveys were completed following two prompts and took participants 5minutes or less to complete. Caregivers rated the surveys as easy to complete, low burden, and just right in length. A daily self-report, using a brief (≤5minutes) survey administered on a smartphone via text message prompt, is a feasible and acceptable method. Future research should extend these findings to understand the generalizability across pediatric cancer caregiving contexts.

Randomized control trial of unconditional versus conditional incentives to increase study enrollment rates in participants at increased risk of lung cancer

IntroductionUnderstanding how incentives and their timing influence study enrollment rates is important to efficient study design and increasing the generalizability of findings. This 2-arm, parallel randomized trial evaluated how conditional vs. unconditional mailed incentives of a $20 gift card affected study enrollment in a sample of participants screened for lung cancer screening. MethodsEligible participants included Black and White adults who underwent lung cancer screening with low-dose CT and had negative screening results at two North Carolina imaging facilities in 2018. We used a stratified randomization scheme, by sex and race, to assign incentive type (conditional vs. unconditional). We used the Tailored Design Method with six points of mailed contact to engage participants. We compared study enrollment rates using chi-square tests and logistic regression analyses. ResultsAfter adjusting for sex, race, age, smoking status, participant residence, and screening site, participants who received unconditional incentives were 74% more likely to enroll than those who received conditional incentives (adjusted OR = 1.74 (95% CI: 1.01, 3.00). ConclusionsType of incentive can play a role in increasing study enrollment, especially mailed surveys that target individuals who currently or previously smoked. Unconditional incentives may be worth the initial cost to engage study participants.

Reasons for Non-Participation in an Actigraphy Study in an Alzheimer’s Disease Center Registry

When recruited individuals decline to participate in research, it can lead to sampling bias, increased costs, and extended duration of data collection. Understanding reasons why eligible participants decline participation may improve study enrollment rates. We aimed to understand barriers to recruitment and data collection in older adults with and without Alzheimer’s disease in the University of Kansas Alzheimer’s Disease Center Registry annual visit. We recruited Registry participants to join an observational sub-study using wrist-worn actigraphy to measure physical activity and sleep. We analyzed reasons for non-enrollment from encounters with non-participating individuals. Of 104 encounters, 37 were never recruited due to appointment cancellation, rescheduling, or no-show. Of the remaining encounters, the most common reasons for non-participation were physical limitations (N = 13), study logistics (e.g., limited supplies; N = 12), participant travel plans (N = 10), and unknown (N = 8). Other categories (N = 6) included disinterest, study partner concerns about pragmatics (e.g., fear that an individual with AD would lose the ActiGraph), problems with the study design (e.g., lack of feedback to participants), and participants’ limited availability or deferment to a later date. These findings offer insight into potential avenues to overcome barriers to participation in older adults already engaged in ongoing research through an Alzheimer’s Disease Center Registry. Researchers could benefit from adapting study procedures to correct for reasons of non-participation. For example, giving more education and reassurance to potential participants about observation and giving feedback regarding activity patterns.

The Impact of Advertisement Messaging on Enrollment of Young Men Who Have Sex With Men for Web-Based Research: Observational Study.

BackgroundRecruiting young men who have sex with men (YMSM) in community settings is difficult. The use of Web-based social networks and dating apps for recruitment can be successful approaches, although little work has been done on the impact of study advertisement content on recruitment.ObjectiveThe aim of this study was to evaluate the effects of advertisement message content on the recruitment of YMSM (aged 18-26 years) for a Web-based focus group study, examining perspectives and preferences for a mobile app that was designed to support sexual health among YMSM.MethodsBetween March and April 2017, a recruitment campaign to promote human papillomavirus vaccination was launched on a popular social networking and dating app for YMSM, with 3 different text-based advertisement themes (technology, cancer prevention, and sexual innuendo). The campaign recruited YMSM across 3 states (Massachusetts, New York, and Pennsylvania). We examined the click-through rates, conversion rates, and enrollment rates of each of the advertisements and examined differences in views and clicks by age, state, and time of day.ResultsThe sexual innuendo advertisement had the highest click rates when compared with both the technology (click rate ratio [CRR] 2.06, 95% CI 1.74-2.45) and cancer prevention (CRR 1.62, 95% CI 1.38-1.90) advertisements. The sexual innuendo advertisement also had higher study enrollment rates compared with the technology (CRR 1.90, 95% CI 1.23-2.83) and cancer prevention (CRR 2.06, 95% CI 1.37-3.13) advertisements. No differences were observed in clicks or enrollment by age, state, or time of day.ConclusionsOur marketing campaign, targeting YMSM, was effective in recruiting participants for a qualitative study, using Web-based focus groups. The sexual innuendo advertisement was the most effective and cost-efficient advertisement of the 3 approaches trialed. Different populations need different targeted strategies for study recruitment. Researchers should work with key representatives to develop and test culturally relevant messaging and approaches that utilize current and popular technologies.

Partnering With Parents to Create a Research Advisory Board in a Pediatric Research Network.

* Abbreviations: CHOP — : Children’s Hospital of Philadelphia PBRN — : Practice-based research network PeRC — : Pediatric Research Consortium Practice-based research networks (PBRNs) are ongoing collaborations of clinicians and researchers to conduct studies that improve clinical practice and patient health. PBRNs have long emphasized input from clinicians as a key component of practice-based research. For example, the American Academy of Pediatrics Pediatric Research in Office Settings network relies on practitioners, as opposed to investigators or administrators, to decide which studies are approved.1 In recent years, the importance of getting input from additional stakeholders, especially patients and their families, has been increasingly prioritized. Patient engagement in research may lead to increased study enrollment rates and greater relevance of study outcomes to families.2 The 2010 Patient Protection and Affordable Care Act funded the creation of the Patient-Centered Outcomes Research Institute, which promotes clinical effectiveness research with sustained engagement of patients, families, and other stakeholders throughout the research process.3 Given this focus, practice-based research studies in which researchers partner with patients and families have become more common. However, models for meaningfully and efficiently engaging parents in pediatric PBRN research decisions, regardless of funder, are needed.4 The Children’s Hospital of Philadelphia (CHOP) created the Pediatric Research Consortium (PeRC) Parent Advisory Board to gather input from families that is used to inform the implementation of practice-based studies. PeRC is a 31-practice, 2-state PBRN involving 205 physicians and 41 nurse practitioners. PeRC includes a diverse population of patients from urban, suburban, and more rural practice settings. To date, 95 research projects have been completed in conjunction with parents. In this article, we describe the partnership between PBRN leaders, researchers, and parents … Address correspondence to Alexander G. Fiks, MD, MSCE, Children’s Hospital of Philadelphia, Roberts Building, Room 10-471, 2716 South St, Philadelphia, PA 19146. E-mail: fiks{at}email.chop.edu

Modernizing Eligibility Criteria for Molecularly Driven Trials.

As more clinical trials of molecularly targeted agents evolve, the number of eligibility criteria seems to be increasing. The importance and utility of eligibility criteria must be considered in the context of the fundamental goal of a clinical trial: to understand the risks and benefits of a treatment in the intended-use patient population. Although eligibility criteria are necessary to define the population under study and conduct trials safely, excessive requirements may severely restrict the population available for study, and often, this population is not reflective of the general population for which the drug would be prescribed. The American Society of Clinical Oncology Cancer Research Committee, which comprises academic faculty, industry representatives, and patient advocates, evaluated this issue. Evaluation results were mixed. Most physicians agreed that excessive eligibility criterias slow study enrollment rates and prolong the duration of enrollment; however, this hypothesis was difficult to validate with the data examined. We propose the organization of a public workshop, with input from regulatory bodies and key stakeholders, with the goal of developing an algorithmic approach to determining eligibility criteria for individual study protocols, which may help guide future investigators and companies in streamlining eligibility criteria in the era of molecularly driven therapy.

Strategies for enrollment of African Americans into cancer genetic studies.

The enrollment of ethnically diverse populations in genetic and genomic research is vital to the parity of benefits resulting from research with biological specimens. Herein, we discuss strategies that may effectively improve the recruitment of African Americans into genetics studies. Specifically, we show that engaging physicians, genetic counselors, and community members is essential to enrolling participants into genetic studies. We demonstrate the impact of utilizing African American genetic counselors on study enrollment rates and implementing a two-page consent form that improved on a lengthy and inefficient consenting process. Lastly, we provided participants with the option of donating saliva instead of blood for study purposes. Descriptive statistics were used. Using the aforementioned strategies, recruitment goals for the Genetic Basis of Breast Cancer Subtype Study at Howard University (HU) were met. Our overall results yielded 182 participants in 18months. Recruitment strategies that involve the engagement of physicians, genetic counselors, and community members may help researchers increase the enrollment of ethnically diverse and hard-to-reach participants into genetic studies.

Patient engagement in research: a systematic review

BackgroundA compelling ethical rationale supports patient engagement in healthcare research. It is also assumed that patient engagement will lead to research findings that are more pertinent to patients’ concerns and dilemmas. However; it is unclear how to best conduct this process. In this systematic review we aimed to answer 4 key questions: what are the best ways to identify patient representatives? How to engage them in designing and conducting research? What are the observed benefits of patient engagement? What are the harms and barriers of patient engagement?MethodsWe searched MEDLINE, EMBASE, PsycInfo, Cochrane, EBSCO, CINAHL, SCOPUS, Web of Science, Business Search Premier, Academic Search Premier and Google Scholar. Included studies were published in English, of any size or design that described engaging patients or their surrogates in research design. We conducted an environmental scan of the grey literature and consulted with experts and patients. Data were analyzed using a non-quantitative, meta-narrative approach.ResultsWe included 142 studies that described a spectrum of engagement. In general, engagement was feasible in most settings and most commonly done in the beginning of research (agenda setting and protocol development) and less commonly during the execution and translation of research. We found no comparative analytic studies to recommend a particular method. Patient engagement increased study enrollment rates and aided researchers in securing funding, designing study protocols and choosing relevant outcomes. The most commonly cited challenges were related to logistics (extra time and funding needed for engagement) and to an overarching worry of a tokenistic engagement.ConclusionsPatient engagement in healthcare research is likely feasible in many settings. However, this engagement comes at a cost and can become tokenistic. Research dedicated to identifying the best methods to achieve engagement is lacking and clearly needed.

The design and implementation of an open-source, data-driven cohort recruitment system: the Duke Integrated Subject Cohort and Enrollment Research Network (DISCERN)

Failure to reach research subject recruitment goals is a significant impediment to the success of many clinical trials. Implementation of health-information technology has allowed retrospective analysis of data for cohort identification and recruitment, but few institutions have also leveraged real-time streams to support such activities. Duke Medicine has deployed a hybrid solution, The Duke Integrated Subject Cohort and Enrollment Research Network (DISCERN), that combines both retrospective warehouse data and clinical events contained in prospective Health Level 7 (HL7) messages to immediately alert study personnel of potential recruits as they become eligible. DISCERN analyzes more than 500000 messages daily in service of 12 projects. Users may receive results via email, text pages, or on-demand reports. Preliminary results suggest DISCERN's unique ability to reason over both retrospective and real-time data increases study enrollment rates while reducing the time required to complete recruitment-related tasks. The authors have introduced a preconfigured DISCERN function as a self-service feature for users. The DISCERN framework is adoptable primarily by organizations using both HL7 message streams and a data warehouse. More efficient recruitment may exacerbate competition for research subjects, and investigators uncomfortable with new technology may find themselves at a competitive disadvantage in recruitment. DISCERN's hybrid framework for identifying real-time clinical events housed in HL7 messages complements the traditional approach of using retrospective warehoused data. DISCERN is helpful in instances when the required clinical data may not be loaded into the warehouse and thus must be captured contemporaneously during patient care. Use of an open-source tool supports generalizability to other institutions at minimal cost.

Black art posters, an incentive to increase study enrollment among Blacks in a large cohort study

Objective Black art posters were offered to replace or augment the established $10 incentive for questionnaire completion in a longitudinal cohort study. Method Eighty-one churches located in the US southern region were divided between two intervention groups, with a control group of 24 churches from the same region. Primary outcome measures were study enrollment rates and questionnaire return rates between December 2003 and July 2004 as a proportion of church goal. Results 9.3% of participants returning questionnaires selected a poster in preference to $10. Half of participants offered both monetary and art incentives indicated a poster selection. Crude questionnaire return rates were 57.4% for the pooled intervention churches and 38.2% for the control churches. Enrollment rates among those offered both incentives were significantly higher ( p < 0.01) than when monetary incentives alone were offered after adjustment for church size, promotional dates, and average income of church members. Survey return rates were also higher in the churches offered both incentives (p = 0.04) . Conclusion These data suggest that the black art posters improved study enrollment and survey return rates. The relatively low rate of poster selection suggests that the art primarily influenced participation indirectly, by creating a more culturally inclusive image of the study.