Challenges and Lessons from Conducting a Community-Engaged Evaluation of a Community Advisory Board-A Case Study from Flint.

Community-engaged research often poses challenges due to exactly those qualities that make it desirable: it provides a new model of research that differs in many ways from top-down, university-led, prospectively designed approaches. While many have discussed the challenges to conducting community-engaged research, few have provided precise and generalizable lessons for how to surmount these challenges. Here we discuss the challenges experienced in a project that was community-engaged at three levels: 1) a research team consisting of an academic and a community partner as well as a community and academic research assistant, 2) the research team engaged with a Community Advisory Board called the CBOP-CERB (Community Based Organization Partners-Community Ethics Research Board) throughout the project, and 3) the research involved recruiting community participants from an area with a historical distrust of researchers and research: Flint Michigan. We also discuss administrative challenges that this multilevel community-engagement posed. Most important, we provide practical lessons in order for future community-engaged research to avoid or mitigate many of these challenges.

Strategies for Recruiting Older Black Men into Aging and Alzheimer's Research.

BACKGROUND: Despite their high risks for Alzheimer's disease, older Black men are minimally represented in Alzheimer's research and clinical trials. The absence of older Black men in Alzheimer's research limits our ability to characterize the changes associated with cognitive impairments in older Black men-a key health disparity concern. METHODS: Drawing on lessons we learned from years of community-based participatory research in Newark, NJ, we highlight recruitment strategies developed alongside community partners to guide our enrollment and retention efforts for Black men. RESULTS: We identified seven recruitment strategies: provide indirect health education through social programming, target older men through the younger men in their lives, go beyond Black churches, use older Black men as trained community ambassadors, enlist the women in Black men's lives, frame research participation as a legacy to leave their sons, and use past and current Black men participants as role models. CONCLUSIONS: These recruitment strategies help us address many barriers to recruiting older Black men. They can be easily implemented by researchers conducting aging and brain health research or interested in working with older Black men and under-represented populations.

Participant recruitment and attrition in surgical randomised trials with placebo controls versus non-operative controls: a meta-epidemiological study and meta-analysis.

OBJECTIVE: To compare differences in recruitment and attrition between placebo control randomised trials of surgery, and trials of the same surgical interventions and conditions that used non-operative (non-placebo) controls. DESIGN: Meta-epidemiological study. DATA SOURCES: Randomised controlled trials were identified from an electronic search of MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials from their inception date to 21 November 2018. STUDY SELECTION: Placebo control trials evaluating efficacy of any surgical intervention and non-operative control trials of the same surgical intervention were included in this study. 25 730 records were retrieved from our systemic search, identifying 61 placebo control and 38 non-operative control trials for inclusion in analysis. OUTCOME MEASURES: Primary outcome measures were recruitment and attrition. These were assessed in terms of recruitment rate (number of participants enrolled, as a proportion of those eligible) and overall attrition rate (composite of dropout, loss to follow-up and cross-overs, expressed as proportion of total sample size). Secondary outcome measures included participant cross-over rate, dropout and loss to follow-up. RESULTS: Unadjusted pooled recruitment and attrition rates were similar between placebo and non-operative control trials. Study characteristics were not significantly different apart from time to primary timepoint which was shorter in studies with placebo controls (365 vs 274 days, p=0.006). After adjusting for covariates (follow-up duration and number of timepoints), the attrition rate of placebo control trials was almost twice as high compared with non-operative controlled-trials (incident rate ratio (IRR) (95% CI) 1.8 (1.1 to 3.0), p=0.032). The incorporation of one additional follow-up timepoint (regardless of follow-up duration) was associated with reduced attrition in placebo control surgical trials (IRR (95% CI) 0.64 (0.52 to 0.79), p<0.001). CONCLUSIONS: Placebo control trials of surgery have similar recruitment issues but higher attrition compared with non-operative (non-placebo) control trials. Study design should incorporate strategies such as increased timepoints for given follow-up duration to mitigate losses to follow-up and dropout. PROSPERO REGISTRATION NUMBER: CRD42019117364.

The usage of population and disease registries as pre-screening tools for clinical trials, a systematic review.

OBJECTIVE: This systematic review aims to outline the use of population and disease registries for clinical trial pre-screening. MATERIALS AND METHODS: The search was conducted in the time period of January 2014 to December 2022 in three databases: MEDLINE, Embase, and Web of Science Core Collection. References were screened using the Rayyan software, firstly based on titles and abstracts only, and secondly through full text review. Quality of the included studies was assessed using the List of Included Studies and quality Assurance in Review tool, enabling inclusion of publications of only moderate to high quality. RESULTS: The search originally identified 1430 citations, but only 24 studies were included, reporting the use of population and/or disease registries for trial pre-screening. Nine disease domains were represented, with 54% of studies using registries based in the USA, and 62.5% of the studies using national registries. Half of the studies reported usage for drug trials, and over 478,679 patients were identified through registries in this review. Main advantages of the pre-screening methodology were reduced financial burden and time reduction. DISCUSSION AND CONCLUSION: The use of registries for trial pre-screening increases reproducibility of the pre-screening process across trials and sites, allowing for implementation and improvement of a quality assurance process. Pre-screening strategies seem under-reported, and we encourage more trials to use and describe their pre-screening processes, as there is a need for standardized methodological guidelines.

Characterizing participants who respond to text, email, phone calls, or postcards in a SARS-CoV-2 prevalence study.

INTRODUCTION: Multiple modalities and frequencies of contact are needed to maximize recruitment in many public health surveys. The purpose of this analysis is to characterize respondents to a statewide SARS-CoV-2 testing study whose participation followed either postcard, phone outreach or electronic means of invitation. In addition, we examine how participant characteristics differ based upon the number of contacts needed to elicit participation. METHODS: This is a cross-sectional analysis of survey data collected from participants who were randomly selected to represent Indiana residents and were invited to be tested for Covid-19 in April 2020. Participants received invitations via postcard, text/emails, and/or robocalls/texts based upon available contact information. The modality, and frequency of contacts, that prompted participation was determined by when the notification was sent and when the participant responded and subsequently registered to participate in the study. Chi square analyses were used to determine differences between groups and significant findings were analyzed using multinomial logistic regression. RESULTS: Respondents included 3,658 individuals and were stratified by postcards (7.9%), text/emails (26.5%), and robocalls/text (65.7%) with 19.7% registering after 1 contact, 47.9% after 2 contacts, and 32.4% after 3 contacts encouraging participation. Females made up 54.6% of the sample and responded at a higher rate for postcards (8.2% vs. 7.5%) and text/emails (28.1 vs. 24.6%) as compared to males (χ2 = 7.43, p = 0.025). Compared to males, females responded at a higher percentage after 1 contact (21.4 vs. 17.9%, χ2 = 7.6, p = 0.023). Those over 60 years responded most often after 2 contacts (χ2 = 27.5, p < 0.001) when compared to others at younger age groups. In regression analysis, participant sex (p = 0.036) age (p = 0.005), educational attainment (p = < 0.0001), and being motivated by "free testing" (p = 0.036) were correlated with participation in the prevalence study. DISCUSSION: Researchers should be aware that the modality of contact as well as the number of prompts used could influence differential participation in public health studies. Our findings can inform researchers developing studies that rely on selective participation by study subjects. We explore how to increase participation within targeted demographic groups using specific modalities and examining frequency of contact.

Multimodal Approaches to Patient Selection for Pancreas Cancer Surgery.

With an overall 5-year survival rate of 12%, pancreas ductal adenocarcinoma (PDAC) is an aggressive cancer that claims more than 50,000 patient lives each year in the United States alone. Even those few patients who undergo curative-intent resection with favorable pathology reports are likely to experience recurrence within the first two years after surgery and ultimately die from their cancer. We hypothesize that risk factors for these early recurrences can be identified with thorough preoperative staging, thus enabling proper patient selection for surgical resection and avoiding unnecessary harm. Herein, we review evidence supporting multidisciplinary and multimodality staging, comprehensive neoadjuvant treatment strategies, and optimal patient selection for curative-intent surgical resections. We further review data generated from our standardized approach at the Mayo Clinic and extrapolate to inform potential future investigations.

Should Children Be Included in Human Challenge Studies?

Human challenge studies, in which human research subjects are intentionally exposed to pathogens to contribute to scientific knowledge, raise many ethical complexities. One controversial question is whether it is ethically permissible to include children as participants. Commentary of the past decades endorses the exclusion of children, while new guidance suggests that pediatric human challenge studies can be ethically permissible. This paper argues that neither children's exclusion nor their inclusion are well justified. I examine and reject three arguments for exclusion, but suggest that these arguments establish pediatric human challenge studies as a complex ethical category of research that requires caution. I then argue for a strong presumption against children's inclusion, by drawing on an analogy to children's inclusion in phase I trials, emphasizing a requirement of necessity, and suggesting that accommodating children's vulnerability promotes an age de-escalation approach for pediatric human challenge studies research. In the final section, I suggest a procedure for ethics review.

Facilitators and barriers to adolescent participation in a TB clinical trial.

The inclusion of adolescents in TB drug trials is essential for the development of safe, child-friendly regimens for the prevention and treatment of TB. TB Trials Consortium Study 31/AIDS Clinical Trials Group A5349 (S31/A5349) enrolled adolescents as young as 12 years old. We assessed investigator and coordinator described facilitators and barriers to adolescent recruitment, enrollment, and retention.Interviews were conducted with six investigators from sites that enrolled adolescent participants and six investigators from non-enrolling sites. Additionally, two focus groups were conducted with study coordinators from enrolling sites and two focus groups with non-enrolling sites. Discussions were transcribed, analyzed, summarized, and summaries were reviewed by Community Research Advisors Group members and research group representatives for content validity.Investigators and coordinators attributed the successful enrollment of adolescents to the establishment and cultivation of external partnerships, flexibility to accommodate adolescents' schedules, staff engagement, recruitment from multiple locations, dedicated recruitment staff working onsite to access potential participants, creation of youth-friendly environments, and effective communications. Non-enrolling sites were mainly hindered by regulations. Suggestions for improvement in future trials focused on study planning and site preparations.Proactive partnerships and collaboration with institutions serving adolescents helped identify and reduce barriers to their inclusion in this trial..

Fundamentals of deep brain stimulation for Parkinson's disease in clinical practice: part 1.

Deep brain stimulation (DBS) is recognized as an established therapy for Parkinson's disease (PD) and other movement disorders in the light of the developments seen over the past three decades. Long-term efficacy is established for PD with documented improvement in the cardinal motor symptoms of PD and levodopa-induced complications, such as motor fluctuations and dyskinesias. Timing of patient selection is crucial to obtain optimal benefits from DBS therapy, before PD complications become irreversible. The objective of this first part review is to examine the fundamental concepts of DBS for PD in clinical practice, discussing the historical aspects, patient selection, potential effects of DBS on motor and non-motor symptoms, and the practical management of patients after surgery.

Nas últimas três décadas, a estimulação cerebral profunda (ECP) se tornou um tratamento bem estabelecido para doença de Parkinson (DP) e outros transtornos do movimento. A eficácia a longo prazo na DP foi bem documentada para a melhora dos sintomas motores cardinais da DP e das complicações induzidas pelo uso do levodopa, como as flutuações motoras e as discinesias. O momento da seleção do paciente é crucial para se obter os benefícios ideais da ECP, antes que as complicações da DP se tornem irreversíveis. O objetivo desta primeira parte da revisão é examinar os conceitos fundamentais da ECP na prática clínica, discutindo os aspectos históricos, a seleção de pacientes, os potenciais efeitos da ECP nos sintomas motores e não motores da doença e o manejo prático dos pacientes após a cirurgia.

Evaluation of respondent-driven sampling in seven studies of people who use drugs from rural populations: findings from the Rural Opioid Initiative.

BACKGROUND: Accurate prevalence estimates of drug use and its harms are important to characterize burden and develop interventions to reduce negative health outcomes and disparities. Lack of a sampling frame for marginalized/stigmatized populations, including persons who use drugs (PWUD) in rural settings, makes this challenging. Respondent-driven sampling (RDS) is frequently used to recruit PWUD. However, the validity of RDS-generated population-level prevalence estimates relies on assumptions that should be evaluated. METHODS: RDS was used to recruit PWUD across seven Rural Opioid Initiative studies between 2018-2020. To evaluate RDS assumptions, we computed recruitment homophily and design effects, generated convergence and bottleneck plots, and tested for recruitment and degree differences. We compared sample proportions with three RDS-adjusted estimators (two variations of RDS-I and RDS-II) for five variables of interest (past 30-day use of heroin, fentanyl, and methamphetamine; past 6-month homelessness; and being positive for hepatitis C virus (HCV) antibody) using linear regression with robust confidence intervals. We compared regression estimates for the associations between HCV positive antibody status and (a) heroin use, (b) fentanyl use, and (c) age using RDS-1 and RDS-II probability weights and no weights using logistic and modified Poisson regression and random-effects meta-analyses. RESULTS: Among 2,842 PWUD, median age was 34 years and 43% were female. Most participants (54%) reported opioids as their drug of choice, however regional differences were present (e.g., methamphetamine range: 4-52%). Many recruitment chains were not long enough to achieve sample equilibrium. Recruitment homophily was present for some variables. Differences with respect to recruitment and degree varied across studies. Prevalence estimates varied only slightly with different RDS weighting approaches, most confidence intervals overlapped. Variations in measures of association varied little based on weighting approach. CONCLUSIONS: RDS was a useful recruitment tool for PWUD in rural settings. However, several violations of key RDS assumptions were observed which slightly impacts estimation of proportion although not associations.

Exploring the Strategic Use of TikTok for Clinical Trial Recruitment: How audiences' Prior Short-Form Video Usage Influences Persuasive Effects.

Guided by the elaboration likelihood model and framing theory, this study explores the potential of short-form video platforms (e.g. TikTok), for targeted clinical trial recruitment. An online experiment compared doctor vs. peer-led videos addressing logistical or psychological barriers to participation, mimicking common TikTok communication tactics. Results indicate that high (vs. low) TikTok users are more persuaded by recruitment messages, and they exhibit stronger intentions to participate in clinical trials. Although doctor-sourced messages generate greater credibility and a more favorable message attitude, peer-sourced messages may be more effective in increasing participation intention. Lastly, doctor-sourced videos that address logistical barriers and peer-sourced videos that discuss psychological barriers result in higher self-efficacy for clinical trial participation. This study contributes to the growing body of research on new media's role in health communication and provides insights into how to strategically utilize TikTok and other short-form video platforms for clinical trial recruitment.

Optimal patient selection for maze procedure in patients undergoing mitral valve disease.

OBJECTIVES: Although risk factors for unsuccessful Maze procedure have been demonstrated, an appropriate patient selection is still controversial. In our institute, Maze procedure is indicated for those whom normal sinus rhythm (NSR) was reestablished by intraoperative direct cardioversion (DC) after ventricular unloading by total cardiopulmonary bypass. The purpose of this study was to evaluate the effectiveness of our indication criteria for Maze procedure in patients with mitral valve disease. METHODS: Between October 2012 and October 2021, MAZE was indicated in 55 patients in whom normal sinus rhythm (NSR) was reestablished by intraoperative direct current cardioversion (DC). Three endpoints and predictors were examined: disappearance of atrial fibrillation (AF), NSR, and A-wave detection. RESULTS: Restoration of NSR by intraoperative DC was confirmed in 43 patients, and these patients underwent MAZE. AF disappeared in 39 patients (90.7%), and F-wave ≥ 0.1 mV was a significant predictive factor (odds ratio (OR) 20.99, 95% CI 1.22-1079.06). NSR was reestablished in 36 patients (83.7%), and F-wave ≥ 0.1 mV (odds ratio 15.62, 95% CI 1.62-359.86) + AF history ≤ 3 years (OR 8.30, 95% CI 1.09-177.04) were significant predictors. A-wave detection was confirmed in 26 patients (60.5%), and left atrial diameter ≤ 55 mm was a significant predictor (OR 5.22, 95% CI 1.28-24.79). CONCLUSIONS: Intraoperative DC after ventricular unloading resulted effective patient selection for concomitant Maze procedure. F-wave and AF history were predictive factor of electrical restoration of AF, and left atrial diameter was predictive factor of restoration of atrial function.

Is central venous catheter in haemodialysis still the main factor of mortality after hospitalization?

BACKGROUND: Haemodialysis is the most frequently prescribed Renal Replacement Therapy modality worldwide. However, patients undergoing this therapy have an unpredictable evolution related to vascular access. OBJECTIVE: To determine the factors associated with the mortality and hospitalization rate in haemodialysis patients at a third-level care Centre in the Dominican Republic. METHODS: This was an observational and prospective study involving a cohort of 192 haemodialysis patients. The patient selection was non-probabilistic for convenience, and a direct source questionnaire was applied. RESULTS: Of the 192 patients in the cohort, 103 (53.6%) were hospitalized and evaluated. The most frequent cause of hospitalization was catheter-related bloodstream infections (53.4%). Almost one-third (28.2%) of the hospitalized patients died, mostly due to infections (12.6%). Of those who died 29 patients (90%) had a Central venous catheter (CVC) with a non-tunnelled catheter (NTCVC) (65.5%); having an NTC CVC makes a patient 85.5 times more likely to be hospitalized than patients with arteriovenous fistulas. CONCLUSION: Vascular access plays a predominant role in the hospitalization and mortality rates in haemodialysis. Patients with an arteriovenous fistula obtained significantly better outcomes than those with central venous catheters.

Histological criteria for selecting patients who need clonality test for non-gastric MALT lymphoma diagnosis.

The histological diagnosis of extranodal marginal zone lymphoma of the mucosa-associated lymphoid tissue (MALT lymphoma) is difficult for pathologists. Recently, digital pathology systems have been widely used to provide tools that can objectively measure lesions on slides. In this study, we measured the extent of marginal zone expansion in suspected MALT lymphoma cases and compared the results with those of a molecular clonality test. In total, 115 patients who underwent an IGH gene rearrangement test for suspected MALT lymphoma were included in this study. All cases were histologically classified into three patterns; "small lymphoid aggregates with no germinal center (Pattern 1)," "lymphoid follicles with germinal center (Pattern 2)" and " fused marginal zone or diffuse small lymphocytic proliferation (Pattern 3)." The proportions of monoclonality in Pattern 1, 2, and 3 were 25.0%, 55.0%, and 97.9%, respectively. The ratios of marginal zone thickness to germinal center diameter and entire lymphoid follicle area to germinal center area were measured in Pattern 2 cases using a digital pathology system. Combining the width cutoff of 1.5 and the areal cutoff of 3.5, the sensitivity, specificity, positive predictive value, and negative predictive value for MALT lymphoma were 96.97%, 70.37%, 80.00%, and 95.00%, respectively. In conclusion, through objective measurement of the marginal zone, suspected cases of MALT lymphoma requiring a molecular clonality test can be effectively selected.

Functional Mitral Regurgitation: Patient Selection and Optimization.

Functional mitral regurgitation appears commonly among all heart failure phenotypes and can affect symptom burden and degree of maladaptive remodeling. Transcatheter mitral valve edge-to-edge repair therapies recently became an important part of the routine heart failure armamentarium for carefully selected and medically optimized candidates. Patient selection is considering heart failure staging, relevant comorbidities, as well as anatomic criteria. Indications and device platforms are currently expanding.