Patient Recruitment Strategies Research Articles

HUNCHEST projects-advancing low-dose CT lung cancer screening in Hungary.

Lung cancer, the leading cause of malignancy-related deaths worldwide, demands proactive measures to mitigate its impact. Low-dose computer tomography (LDCT) has emerged as a promising tool for secondary prevention through lung cancer screening (LCS). The HUNCHEST study, inspired by the success of international trials, including the National Lung Cancer Screening Trial and the Dutch NELSON study, embarked on the first LDCT-based LCS program in Hungary. The initiative assessed the screening efficiency, incorporating lung function tests and exploring the interplay between lung cancer and chronic obstructive pulmonary disease (COPD). Building upon this foundation, an implementation trial involving 18 Hungarian centers supported by the Ministry of Human Capacities demonstrated the feasibility of LCS within a multicentric framework. These centers, equipped with radiology capabilities, collaborated with multidisciplinary oncology teams, ensuring optimal patient pathways. However, a critical challenge remained the patient recruitment. To address this, the HUNCHEST 3 project, initiated in 2023, seeks to engage general practitioners (GPs) to reach out to eligible patients within a municipality collective of 60 thousand inhabitants. The project's ultimate success is contingent upon the willingness of eligible individuals to undergo LDCT scans. In conclusion, the HUNCHEST program represents a crucial step in advancing lung cancer screening in Hungary. With a focus on efficiency, multidisciplinary collaboration, and innovative patient recruitment strategies, it endeavors to contribute to the reduction of lung cancer mortality and serve as a blueprint for potential nationwide LCS programs.

Landscape and Saturation Analysis of Mutations Associated With Race in Cancer Genomes by Clinical Sequencing.

Differences in cancer genomes between racial groups may impact tumor biology and health disparities. However, the discovery of race-associated mutations is constrained by the limited representation and sample size of different racial groups in prior genomic studies. We evaluated the influence of race on the frequency of gene mutations using the Genomics, Evidence, Neoplasia, Information, Exchange database, a large genomic dataset aggregated from clinical sequencing. Matched cohort analyses were used to identify histology-specific race-associated mutations including increased TERT promoter mutations in Black and Asian patients with gliomas and bladder cancers, and a decreased frequency of mutations in DNA repair pathway genes and subunits of the SWI/SNF chromatin complex in Asian and Black patients across multiple cancer types. The distribution of actionable mutations in oncogenes was also race-specific, demonstrating how targeted therapies may have a disparate impact on racial groups. Down-sampling analyses indicate that larger sample sizes are likely to discover more race-associated mutations. These results provide a resource to understand differences in cancer genomes between racial groups which may inform the design of clinical studies and patient recruitment strategies in biomarker trials.

Recruitment strategies and retention rates for five National Dental PBRN studies.

We describe a retrospective assessment of practitioner and patient recruitment strategies, patient retention strategies, and rates for five clinical studies conducted in the National Dental Practice-Based Research Network between 2012 and 2019, and practitioner and patient characteristics associated with retention. Similar recruitment strategies were adopted in the studies. The characteristics of the practitioners and patients are described. The proportion of patients who either attended a follow-up (FU) assessment or completed an online assessment was calculated. For studies with multiple FU visits or questionnaire assessments, rates for completing each FU were calculated, as were the rates for completing any and for completing all FU assessments. The associations of practitioner and patient characteristics with all clinic FU visits, and with the completion of all assessments for a study were ascertained. Overall, 591 practitioners and 12,159 patients were included. FU rates by patients for any assessment varied from 91% to 96.5%, and rates for participating in all assessments ranged from 68% to 87%. The mean total number of patients each practitioner recruited was 21 (sd = 15); the mean number per study was 13 (sd = 7). For practitioners, practice type and patient enrollment were associated with greater clinic retention, while only race was associated with their patients completing post-visit online assessments. For patients, age was associated with clinic retention, while female gender, age, race, and education were all associated with greater completion of post-visit online assessments. The Network efficiently recruited practitioners and patients and achieved high patient retention rates for the five studies.

Why We Fail: An Analysis of Terminated Interventional Clinical Trials in Lymphoma

Introduction: Clinical trials serve as the cornerstone for advancing therapeutic and clinical strategies in Lymphoma. Learning from prematurely terminated trials provides valuable insights for researchers and drug developers. This study analyses interventional clinical trials in lymphoma terminated between 2010 and 2023, aiming to identify common factors contributing to their failure and improve future research in Lymphoma. Methods The study identified clinical trials in Lymphoma registered in the US between 01/01/2010, and 01/07/2023, using the InovaSight platform. The analysis included trials investigating drugs in phases I-III with at least one recruited patient. Phase 4 studies, early access programs, and trials examining medical devices were excluded, as were trials terminated early due to positive efficacy signals. Natural language processing (NLP) & classification algorithms were used to categorize trials into distinct phases of clinical development and were also applied to identify reasons for trial termination from official registrations and relevant publications. These reasons were then characterized using the InovaSight trial ontology for thematic analysis. Enriching features, including mechanism of action information, design characteristics, target enrolment, and inclusion criteria, were generated and linked for each eligible trial. The analysis was conducted using the InovaSight drug development platform, which employs responsible artificial intelligence to expedite the development of novel therapeutics for haematological malignancies. Results: A total of 306 trials met the inclusion criteria, with phase II trials being most frequently withdrawn (49.3%), followed by phase I (42.5%) and phase III (8.2%). The trials spanned from 2010-01-31 to 2021-12-15. Among terminated studies, single-arm trials were most frequent (64%), followed by two-armed designs (21.2%) and three or more arms (14.7%). A concentration of mechanisms of action were observed across all phases (further described in poster). Reasons for early termination included enrolment issues, sponsor decisions, lack of efficacy, safety concerns, funding withdrawal, investigator-related issues, study irrelevance, drug supply problems, COVID-19, and unspecified reasons. The most common reason for early termination was enrolment issues in Phase I and Phase II studies, and sponsor decisions in Phase III studies. Detailed results are presented in Figure 1. Discussion: Our analysis identified a total of 306 trials that met the inclusion criteria, encompassing different phases of clinical development. Interestingly, phase II trials were the most frequently withdrawn, followed by phase I and phase III trials. This observation suggests that a considerable number of trials face challenges during the intermediate stages of development, which could be attributed to various factors such as safety concerns, lack of efficacy, or financial constraints. Our analysis revealed a concentration of similar mechanisms of action across all trial phases. This finding suggests that certain therapeutic areas or drug targets may be more prone to early termination. Exploring the underlying reasons for this pattern could provide valuable insights for future trial planning and design (This is further elucidated in the full presentation). Among the various reasons for early termination, enrolment issues emerged as the most common factor in both Phase I and Phase II studies. This highlights the critical need for in depth and principled approaches to study feasibility assessment routed in an evidence-based methodology. In contrast, sponsor decisions were the leading cause of termination in Phase III trials. This finding suggests that late-stage trials are more susceptible to decisions made by the trial sponsors, which could be influenced by factors such as financial considerations or market dynamics. The results underscore the importance of careful trial planning, patient recruitment strategies, and effective collaboration between sponsors, investigators, and regulatory bodies. Understanding the challenges and factors contributing to trial termination can aid in optimizing future trial designs, mitigating risks, and improving the efficiency of drug development processes.

Acupuncture vs Massage for Pain in Patients Living With Advanced Cancer

Pain is challenging for patients with advanced cancer. While recent guidelines recommend acupuncture and massage for cancer pain, their comparative effectiveness is unknown. To compare the effects of acupuncture and massage on musculoskeletal pain among patients with advanced cancer. A multicenter pragmatic randomized clinical trial was conducted at US cancer care centers consisting of a northeastern comprehensive cancer center and a southeastern cancer institute from September 19, 2019, through February 23, 2022. The principal investigator and study statisticians were blinded to treatment assignments. The duration of follow-up was 26 weeks. Intention-to-treat analyses were performed (linear mixed models). Participants included patients with advanced cancer with moderate to severe pain and clinician-estimated life expectancy of 6 months or more. Patient recruitment strategy was multipronged (eg, patient database queries, mailings, referrals, community outreach). Eligible patients had English or Spanish as their first language, were older than 18 years, and had a Karnofsky score greater than or equal to 60 (range, 0-100; higher scores indicating less functional impairment). Weekly acupuncture or massage for 10 weeks with monthly booster sessions up to 26 weeks. The primary end point was the change in worst pain intensity score from baseline to 26 weeks. The secondary outcomes included fatigue, insomnia, and quality of life. The Brief Pain Inventory (range, 0-10; higher numbers indicate worse pain intensity or interference) was used to measure the primary outcome. The secondary outcomes included fatigue, insomnia, and quality of life. A total of 298 participants were enrolled (mean [SD] age, 58.7 [14.1] years, 200 [67.1%] were women, 33 [11.1%] Black, 220 [74.1%] White, 46 [15.4%] Hispanic, and 78.5% with solid tumors). The mean (SD) baseline worst pain score was 6.9 (1.5). During 26 weeks, acupuncture reduced the worst pain score, with a mean change of -2.53 (95% CI, -2.92 to -2.15) points, and massage reduced the Brief Pain Inventory worst pain score, with a mean change of -3.01 (95% CI, -3.38 to -2.63) points; the between-group difference was not significant (-0.48; 95% CI, -0.98 to 0.03; P = .07). Both treatments also improved fatigue, insomnia, and quality of life without significant between-group differences. Adverse events were mild and included bruising (6.5% of patients receiving acupuncture) and transient soreness (15.1% patients receiving massage). In this randomized clinical trial among patients with advanced cancer, both acupuncture and massage were associated with pain reduction and improved fatigue, insomnia, and quality of life over 26 weeks; however, there was no significant different between the treatments. More research is needed to evaluate how best to integrate these approaches into pain treatment to optimize symptom management for the growing population of people living with advanced cancer. ClinicalTrials.gov Identifier: NCT04095234.

Abstract 15763: Increasing Diversity Among Research Participants Through Patient Engagement in the Congenital Heart Initiative

Background: The Congenital Heart Initiative (CHI) is the first patient-powered digital registry for adults with congenital heart disease (ACHD). The CHI-Redefining Outcomes and Navigation to Adult-Centered Care (CHI-RON) study is built upon the CHI as a unique collaboration with PCORnet. Goal: Recruitment of populations that are racially diverse, younger, out-of-care, and male has been challenging in ACHD studies. Our goal was to design patient engagement and recruitment strategies to increase these underrepresented populations. Methods: Launched in December 2020, patients across the globe can self-enroll in the CHI registry. The CHI-RON study, initiated in May 2022, recruits ACHD patients at 12 PCORnet centers. Patients are involved in all aspects of the study including recruitment (see Figure 1). Results: As of May 2023, a total of 2,520 participants were recruited by CHI-RON centers while 1,494 self-enrolled in the CHI. Most participants report complex CHD anatomy (n=1,660, 49%). A total of 762 (36%) participants are considered out of care. CHI-RON recruitment methodologies increased representation when compared to self-enrolled CHI participants in terms of ethnicity (10.3 % vs 7.4% Hispanic, p=0.005), race (5.4% vs 2.6%, African American, p<0.001), sex (41% vs 28% male, p<0.001), age (34.8 +/-12.5 years vs 44.5 +/- 14.3 years, p<0.001), and education (33% vs 22% high school equivalent or less, p<0.001). Most patients involved in the study team (n=11, 83%) reported a very to extremely high degree of meaningfulness (average score 85.2) per the Patient Engagement in Research Scale (PEIRS-22). The mean scores of each of the seven subdomains demonstrated significant meaningfulness, especially in the subdomains of convenience, contributions, and benefits. Conclusions: Patient engagement is critical to improving the inclusion of underrepresented populations in clinical research and ensuring alignment with the needs of ACHD patients.

Leigh syndrome global patient registry: uniting patients and researchers worldwide

BackgroundLeigh Syndrome (LS) is a rare genetic neurometabolic disorder, that leads to the degeneration of the central nervous system and subsequently, early death. LS can be caused by over 80 mutations in mitochondrial or nuclear DNA. Patient registries are important for many reasons, such as studying the natural history of the disease, improving the quality of care, and understanding the healthcare burden. For rare diseases, patient registries are significantly important as patient numbers are small, and funding is limited. Cure Mito Foundation started a global patient registry for LS in September 2021 to identify and learn about the LS patient population, facilitate clinical trial recruitment, and unite international patients and researchers. Priorities were to allow researchers and industry partners to access data at no cost through a clear and transparent process, active patient engagement, and sharing of results back to the community.ResultsPatient registry platform, survey design, data analysis process, and patient recruitment strategies are described. Reported results include demographics, diagnostic information, symptom history, loss of milestones, disease management, healthcare utilization, quality of life, and caregiver burden for 116 participants. Results show a high disease burden, but a relatively short time to diagnosis. Despite the challenges faced by families impacted by Leigh syndrome, participants, in general, are described as having a good quality of life and caregivers are overall resilient, while also reporting a significant amount of stress.ConclusionThis registry provides a straightforward, no-cost mechanism for data sharing and contacting patients for clinical trials or research participation, which is important given the recruitment challenges for clinical trials for rare diseases. This is the first publication to present results from a global patient registry for Leigh Syndrome, with details on a variety of patient-specific and caregiver outcomes reported for the first time. Additionally, this registry is the first for any mitochondrial disease with nearly 70% of participants residing outside of the United States. Future efforts include continued publication of results and further collaboration with patients, industry partners, and researchers.

The Sacro-femoral-pubic Angle Is Unreliable to Estimate Pelvic Tilt: A Meta-analysis.

The accurate measurement of pelvic tilt is critical in hip and spine surgery. A sagittal pelvic radiograph is most often used to measure pelvic tilt, but this radiograph is not always routinely obtained and does not always allow the measurement of pelvic tilt because of problems with image quality or patient characteristics (such as high BMI or the presence of a spinal deformity). Although a number of recent studies have explored the correlation between pelvic tilt and the sacro-femoral-pubic angle using AP radiographs (SFP method), which aimed to estimate pelvic tilt without a sagittal radiograph, disagreement remains about whether the SFP method is sufficiently valid and reproducible for clinical use. The purpose of this meta-analysis was to evaluate the correlation between SFP and pelvic tilt in the following groups: (1) overall cohort, (2) male and female cohort, and (3) skeletally mature and immature cohorts (young and adult groups, defined as patients older or younger than 20 years). Additionally, we assessed (4) the errors of SFP-estimated pelvic tilt angles and determined (5) measurement reproducibility using the intraclass correlation coefficient. This meta-analysis was reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and registered in PROSPERO (record ID: CRD42022315673). PubMed, Embase, Cochrane, and Web of Science were screened in July 2022. The following keywords were used: sacral femoral pubic, sacro femoral pubic, or SFP. The exclusion criteria were nonresearch articles such as commentaries or letters and studies that only investigated relative pelvic tilt rather than absolute pelvic tilt. Although the included studies had different patient recruitment strategies, study quality-wise, they all used an adequate amount of radiographs for landmark annotation and applied a correlation analysis for the relationship between the SFP angle and pelvic tilt. Thus, no risk of bias was found. Participant differences were mitigated via subgroup and sensitivity analyses to remove outliers. Publication bias was assessed using the p value of a two-tailed Egger regression test for the asymmetry of funnel plots, as well as the Duval and Tweedie trim and fill method for potential missing publications to impute true correlations. The extracted correlation coefficients r were pooled using the Fisher Z transformation with a significance level of 0.05. Nine studies were included in the meta-analysis, totaling 1247 patients. Four studies were used in the sex-controlled subgroup analysis (312 male and 460 female patients), and all nine studies were included in the age-controlled subgroup analysis (627 adults and 620 young patients). Moreover, a sex-controlled subgroup analysis was conducted in two studies with only young cohorts (190 young male patients and 220 young female patients). The overall pooled correlation coefficient between SFP and pelvic tilt was 0.61, with high interstudy heterogeneity (I 2 = 76%); a correlation coefficient of 0.61 is too low for most clinical applications. The subgroup analysis showed that the female group had a higher correlation coefficient than the male group did (0.72 versus 0.65; p = 0.03), and the adult group had a higher correlation coefficient than the young group (0.70 versus 0.56; p < 0.01). Three studies reported erroneous information about the measured pelvic tilt and calculated pelvic tilt from the SFP angle. The mean absolute error was 4.6° ± 4.5°; in one study, 78% of patients (39 of 50) were within 5° of error, and in another study, the median absolute error was 5.8º, with the highest error at 28.8° (50 female Asian patients). The intrarater intraclass correlation coefficients ranged between 0.87 and 0.97 for the SFP angle and between 0.89 and 0.92 for the pelvic tilt angle, and the interrater intraclass correlation coefficients ranged between 0.84 and 1.00 for the SFP angle and 0.76 and 0.98 for the pelvic tilt angle. However, large confidence intervals were identified, suggesting considerable uncertainty in measurement at the individual radiograph level. This meta-analysis of the best-available evidence on this topic found the SFP method to be unreliable to extrapolate sagittal pelvic tilt in any patient group, and it was especially unreliable in the young male group (defined as patients younger than age 20 years). Correlation coefficients generally were too low for clinical use, but we remind readers that even a high correlation coefficient does not alone justify clinical application of a metric such as this, unless further subgroup analyses find low error and low heterogeneity, which was not the case here. Further ethnicity-segregated subgroup analyses with age, sex, and diagnosis controls could be useful in the future to determine whether there are some subgroups in which the SFP method is useful. Level III, diagnostic study.

Diagnostic accuracy of multiplex respiratory pathogen panels for influenza or respiratory syncytial virus infections: systematic review and meta-analysis

Respiratory syncytial virus (RSV) and influenza viruses are important global causes of morbidity and mortality. We evaluated the diagnostic accuracy of the Luminex NxTAG respiratory pathogen panels (RPPs)™ (index) against other RPPs (comparator) for detection of RSV and influenza viruses. Studies comparing human clinical respiratory samples tested with the index and at least one comparator test were included. A random-effect latent class meta-analysis was performed to assess the specificity and sensitivity of the index test for RSV and influenza. Risk of bias was assessed using the QUADAS-2 tool and certainty of evidence using GRADE. Ten studies were included. For RSV, predicted sensitivity was 99% (95% credible interval [CrI] 96–100%) and specificity 100% (95% CrI 98–100%). For influenza A and B, predicted sensitivity was 97% (95% CrI 89–100) and 98% (95% CrI 88–100) respectively; specificity 100% (95% CrI 99–100) and 100% (95% CrI 99–100), respectively. Evidence was low certainty. Although index sensitivity and specificity were excellent, comparators’ performance varied. Further research with clear patient recruitment strategies could ascertain performance across different populations.Protocol Registration: Prospero CRD42021272062.

Early Termination of a Palliative Care Trial: Perspectives of Multiple Stakeholders on Barriers to Palliative Care and Research.

Background: Although payment for home-based palliative care (HBPC) is slowly spreading, there remains significant challenges in engaging patients and physicians in palliative care programs and research. This challenge was illustrated in our previous HBPC trial that failed to identify and enroll eligible patients in both the study and in HBPC services. Objectives: The objective of this study was to determine challenges to participation in HBPC and in research among patients, caregivers, primary care physicians, HBPC providers, and accountable care organizations (ACOs). Design: We conducted a qualitative study employing individual interviews and focus groups. Setting/Subjects: We recruited patients (n = 17), caregivers (n = 8), primary care providers (n = 31), home-based care providers (n = 25), and ACO administrators and leaders (n = 12) from California, United States. Measurements: We used semistructured interview protocols to elicit perceived barriers to HBPC services and research. Results: We identified four overarching themes related to barriers to HBPC and palliative care research. These themes included: (1) limitations of patient recruitment strategies; (2) timing of stakeholder engagement; (3) lack of palliative care health literacy; and (4) novelty of the HBPC market. Conclusion: These findings point to factors that contributed to the failure, and subsequent closure, of the original randomized controlled trial. Our findings may inform the further development of HBPC and, more generally, palliative care practice and policy. ClinicalTrials.gov Identifier: NCT03128060.

Diversity and Recruitment of Minorities in Clinical Trials: An Unmet Need

Patient centricity has led to the idea that drugs should answer medical needs not only defined by the medical bodies but relevant for the patients themselves. This implies that the diversity of the patients should be represented in clinical trials. Disparities in representation of diverse populations in clinical trials have been well-documented for several pathologies like arterial hypertension, diabetes but also in oncology. Today, Caucasian patients included in clinical trials represent at least 75% of the clinical trials population even in pathologies where minorities are largely more affected than Caucasians. Filling the gap in diversity is an important matter to ensure ethics, good practices, regulatory compliance, patient safety and scientific validity. To achieve their recruitment goals and being patient centric, sponsors and investigational sites need to pay attention of this problem and put in place specific strategies. Mistrust of patients of minority groups toward clinical research is one of the main barriers along with lack of access to clinical trials (low awareness, communication barriers, distance to investigational sites). Adapted communication, community-based strategies are some of the useful strategies directed to the patients. Investigators may not encounter diverse populations in their area or may not be aware of unconscious bias when identifying patients suitable for a clinical trial. Looking for referrals and raising awareness of the risk of bias with training on culturally sounded approaches could help investigators to recruit more diverse populations. Lack of awareness and costs may prevent sponsors to focus on diversity but ethics, benefits of data acquisition and patient centricity should be enough motivators to modify this trend. Patients, investigators and sponsors have their own barriers to tackle the lack of diversity in clinical trials. The cultural background of all stakeholders is an important factor in those barriers. Only multidisciplinary approaches including human sciences would help to define patient recruitment strategies that would mitigate the current lack of diversity

Diversity and Recruitment of Minorities in Clinical Trials: An Unmet Need

Patient centricity has led to the idea that drugs should answer medical needs not only defined by the medical bodies but relevant for the patients themselves. This implies that the diversity of the patients should be represented in clinical trials. Disparities in representation of diverse populations in clinical trials have been well-documented for several pathologies like arterial hypertension, diabetes but also in oncology. Today, Caucasian patients included in clinical trials represent at least 75% of the clinical trials population even in pathologies where minorities are largely more affected than Caucasians. Filling the gap in diversity is an important matter to ensure ethics, good practices, regulatory compliance, patient safety and scientific validity. To achieve their recruitment goals and being patient centric, sponsors and investigational sites need to pay attention of this problem and put in place specific strategies. Mistrust of patients of minority groups toward clinical research is one of the main barriers along with lack of access to clinical trials (low awareness, communication barriers, distance to investigational sites). Adapted communication, community-based strategies are some of the useful strategies directed to the patients. Investigators may not encounter diverse populations in their area or may not be aware of unconscious bias when identifying patients suitable for a clinical trial. Looking for referrals and raising awareness of the risk of bias with training on culturally sounded approaches could help investigators to recruit more diverse populations. Lack of awareness and costs may prevent sponsors to focus on diversity but ethics, benefits of data acquisition and patient centricity should be enough motivators to modify this trend. Patients, investigators and sponsors have their own barriers to tackle the lack of diversity in clinical trials. The cultural background of all stakeholders is an important factor in those barriers. Only multidisciplinary approaches including human sciences would help to define patient recruitment strategies that would mitigate the current lack of diversity.

Patient recruitment strategies for adaptive enrichment designs with time-to-event endpoints

BackgroundAdaptive enrichment designs for clinical trials have great potential for the development of targeted therapies. They enable researchers to stop the recruitment process for a certain population in mid-course based on an interim analysis. However, adaptive enrichment designs increase the total trial period owing to the stoppage in patient recruitment to make interim decisions. This is a major drawback; it results in delays in the submission of clinical trial reports and the appearance of drugs on the market. Here, we explore three types of patient recruitment strategy for the development of targeted therapies based on the adaptive enrichment design.MethodsWe consider recruitment methods which provide an option to continue recruiting patients from the overall population or only from the biomarker-positive population even during the interim decision period. A simulation study was performed to investigate the operating characteristics by comparing an adaptive enrichment design using the recruitment methods with a non-enriched design.ResultsThe number of patients was similar for both recruitment methods. Nevertheless, the adaptive enrichment design was beneficial in settings in which the recruitment period is expected to be longer than the follow-up period. In these cases, the adaptive enrichment design with continued recruitment from the overall population or only from the biomarker-positive population even during the interim decision period conferred a major advantage, since the total trial period did not differ substantially from that of trials employing the non-enriched design. By contrast, the non-enriched design should be used in settings in which the follow-up period is expected to be longer than the recruitment period, since the total trial period was notably shorter than that of the adaptive enrichment design. Furthermore, the utmost care is needed when the distribution of patient recruitment is concave, i.e., when patient recruitment is slow during the early period, since the total trial period is extended.ConclusionsAdaptive enrichment designs that entail continued recruitment methods are beneficial owing to the shorter total trial period than expected in settings in which the recruitment period is expected to be longer than the follow-up period and the biomarker-positive population is promising.

Patient Recruitment in Radiation Therapy Research: An Evaluation of Local Challenges

IntroductionLocally-initiated research studies in radiation therapy (RT) aim to substantiate clinical processes and are an effective approach to gather evidence for advances in patient care, new techniques, and protocols. The aim of this study was to retrospectively quantify recruitment challenges at a radiation oncology network (RON). MethodsFive locally initiated studies were included for analysis through the criteria of being undertaken within 2001–2017, initiated through local research teams, and having recruitment records available. Data extraction from each study included duration, aims, patient activities, recruitment strategy, target number of participants, and number of participants who were recruited/not recruited and who withdrew from the study. Reasons for nonregistration and withdrawal were recorded if available. Two studies are presented as case studies. ResultsIncluded studies were diverse in patient population and study aim and included patient immobilization (lung and breast cancer), evaluation of radiation-induced esophagitis, documentation of anatomical and dosimetric changes in patients with head and neck cancer, and education (breast cancer). The exclusion of non–English-speaking patients, which is significant for the RON, which covers a wide cultural and linguistic diversity, was an important limiting factor, along with RT patients' disinterest in participation. DiscussionChallenges experienced in the evaluated RON studies are similar to non-RT clinical trials and included difficulties with patients interacting with study protocol, health practitioners' influence, and patient-related inclusion issues. ConclusionThe resulting database provides a foundation for continued monitoring and documentation of study recruitment practice, which could elicit positive effects on planning and implementation of future patient recruitment strategies in RT locally initiated studies.

Cancer clinical trials – Survey evaluating patient participation and acceptance in a university-based Comprehensive Cancer Center (CCC)

IntroductionProspective clinical trials are essential to translate new therapy concepts or rather any scientific development into the medical routine. Besides a sophisticated trial protocol, the success of clinical trials depends on patient recruitment and participation. Patient recruitment remains a challenge and depends on several factors. To get a current picture of the patients’ attitude, we conducted the present survey. MethodsWe designed a survey with seven questions, which was given to all oncological patients treated within a timeframe of three months between Mai and July 2017. Participation was voluntary and anonymous. The questionnaire mainly inquires patients’ participation in clinical trials in a university-based setting, their attitude towards clinical trials regarding risks and benefits, and their source of information in this context. Results771 patients (1:1 male/female) participated with a median age of 61 years (range 18–91 years) with a response rate of 71.5%. Of all, 17.8% (137/771) were participating in a clinical trial. The most mentioned reason was to serve medical progress and cancer research. Out of the patients not currently participating in a trial, 79 (12.7%, 79/623) refusers named the following main reasons: extensive travel time to the clinic, no therapeutic advantage, and too time-consuming. Out of the patients not offered to take part in a trial, 265 (51.0%, 265/520) would participate if offered. Of all patients, 8.3% (64/771) used the clinics' homepage as a source of information, of those 79.7% (51/64) were satisfied with its content. To enhance patient recruitment strategies, we asked how patients wish to be informed about possible trials: More than half (52.0%) of the questioned patients preferred an individual medical consultation with their physician.We further analyzed the trial participation depending on age, gender, unit, and tumor entity. We could show a significant influence of age (p < 0.001) but not for gender (p = 0.724). The trial participation was also significantly associated with the treating unit (p < 0.001) and tumor entity (p = 0.001). ConclusionPatients are willing to participate in clinical trials. Better information strategies need to be implemented. Physicians need to be aware of running trials within their department and must counseling counsel patients effectively to improve recruitment. Trial concepts should keep in mind patients’ needs including an adequate number of appointments, positive risk-benefit profiles, and information material.

Meta-analysis investigating post-exertional malaise between patients and controls.

Post-exertional malaise is either required or included in many previously proposed case definitions of myalgic encephalomyelitis/chronic fatigue syndrome. A meta-analysis of odds ratios (ORs; association between patient status and post-exertional malaise status) and a number of potential moderators (i.e. study-level characteristics) of effect size were conducted. Post-exertional malaise was found to be 10.4 times more likely to be associated with a myalgic encephalomyelitis/chronic fatigue syndrome diagnosis than with control status. Significant moderators of effect size included patient recruitment strategy and control selection. These findings suggest that post-exertional malaise should be considered a cardinal symptom of myalgic encephalomyelitis/chronic fatigue syndrome.

Well-being and quality of life among oral cancer patients – Psychological vulnerability and coping responses upon entering initial treatment

BackgroundLittle is known about the psychological constitution and potential coping mechanisms of oral cancer patients when they enter initial treatment. This study aimed at 1) establishing a feasible study protocol and 2) implementing it to examine patients' coping and psychological responses during the initial treatment phase in the hospital. MethodsIn three consecutive feasibility phases a study procedure including measurement time points and instrumentation as well as a patient recruitment strategy was developed. To assess patients' responses, the following qualitative (interviews) and quantitative (questionnaires) measures were applied: WOC-CA, briefCOPE, HADS, EORTCQlQC30- H&N35 and SAM/POMS. ResultsResults revealed a highly burdened and distressed patient group that had not yet developed clear coping strategies. Further, one third of examined patients showed severe levels of anxiety and depression, indicating a high vulnerability to develop psychological disorders. ConclusionAt this early stage of oral cancer treatment, potential psychosocial interventions should prioritize addressing anxiety and depression to enable patients to develop functional coping strategies later on.

A Novel Patient Recruitment Strategy: Patient Selection Directly from the Community through Linkage to Clinical Data.

This article presents and describes our methods in developing a novel strategy for recruitment of underrepresented, community-based participants, for pragmatic research studies leveraging routinely collected electronic health record (EHR) data. We designed a new approach for recruiting eligible patients from the community, while also leveraging affiliated health systems to extract clinical data for community participants. The strategy involves methods for data collection, linkage, and tracking. In this workflow, potential participants are identified in the community and surveyed regarding eligibility. These data are then encrypted and deidentified via a hashing algorithm for linkage of the community participant back to a record at a clinical site. The linkage allows for eligibility verification and automated follow-up. Longitudinal data are collected by querying the EHR data and surveying the community participant directly. We discuss this strategy within the context of two national research projects, a clinical trial and an observational cohort study. The community-based recruitment strategy is a novel, low-touch, clinical trial enrollment method to engage a diverse set of participants. Direct outreach to community participants, while utilizing EHR data for clinical information and follow-up, allows for efficient recruitment and follow-up strategies. This new strategy for recruitment links data reported from community participants to clinical data in the EHR and allows for eligibility verification and automated follow-up. The workflow has the potential to improve recruitment efficiency and engage traditionally underrepresented individuals in research.

Follow-up in patients with a burn-related emergency department visit: a feasibility study

BackgroundData on epidemiology, costs, and outcomes of burn-related injuries presenting at emergency departments (EDs) are scarce. To obtain such information, a questionnaire study with an adequate response rate is imperative. There is evidence that optimized strategies can increase patient participation. However, it is unclear whether this applies to burn patients in an ED setting. The objective of this feasibility study was to optimize and evaluate patient recruitment strategy and follow-up methods in patients with burn injuries presenting at EDs.MethodsIn a prospective cohort study with a 6-month follow-up, patients with burn-related injuries attending two large EDs during a 3-month study period were included. Eligible patients were quasi-randomly allocated to a standard or optimized recruitment strategy by week of the ED visit. The standard recruitment strategy consisted of an invitation letter to participate, an informed consent form, a questionnaire, and a franked return envelope. The optimized recruitment strategy was complemented by a stamped returned envelope, monetary incentive, sending a second copy of the questionnaire, and a reminder by telephone in non-responders. Response rates were calculated, and questionnaires were used to assess treatment, costs, and health-related quality of life.ResultsA total of 87 patients were included of which 85 were eligible for the follow-up study. There was a higher response rate at 2 months in the optimized versus the standard recruitment strategy (43.6% vs. 20.0%; OR = 3.1 (95% CI 1.1–8.8)), although overall response is low. Non-response analyses showed no significant differences in patient, burn injury or treatment characteristics between responders versus non-responders.ConclusionsThis study demonstrated that response rates can be increased with an optimized, but more labor-intensive recruitment strategy, although further optimization of recruitment and follow-up is needed. It is feasible to assess epidemiology, treatment, and costs after burn-related ED contacts.

Into the Light: Using Technology to Develop a Mother/Family Centered Peer Support Network

This paper highlights the work of Postpartum Progress Inc., to engage with large online communities of women experiencing a perinatal mental health issue, in order to explore the efficacy of peer support as a treatment modality. "Into the Light" is a Patient Centered Outcomes Research Institute (PCORI) Pipeline to Proposal project that will bring together diverse stakeholders and patients to build collaborative partnerships. Project goals include developing patient engagement, recruitment and dissemination strategies that reflect the needs of this patient population. Increasing patient access to easily understood information about treatment options when making health care decisions and improving patient-centered research strategies are also aims of the project. A Spanish translation of this publication is available to download under "Additional Files".