Telephone Screening Research Articles

Comparison of targeted web-based advertising versus traditional methods for recruiting older adults into clinical trials.

Recruiting older adults into clinical trials can be particularly challenging. Our objective was to determine if targeted web-based advertising is an effective recruitment strategy. We compared the recruitment rates of traditional and targeted web-based methods for three representative clinical trials involving older adults. All studies utilized traditional recruitment methods initially, but shifted toward primarily targeted web-based advertising after experiencing slow recruitment rates. We found that web-based advertising reached more individuals compared to traditional methods. Compared to traditional methods, web-based methods also had at least twice the rate of expressed interest, completion of telephone and in-person screening, eligibility, and enrollment. Additionally, the proportion of individuals excluded after the telephone screening did not differ according to whether targeted web-based advertising (STAMINA: 51%; Berries and Steps: 62%; ISTIM: 20%) or traditional methods (STAMINA: 48%; Berries and Steps: 69%; ISTIM: 23%) were used within each study. Those recruited using web-based advertisements tended to be younger compared to traditional methods, but were similar in racial distribution and education. Targeted web-based advertisements may be more effective in recruiting older adults for clinical trials at a faster rate than traditional recruitment methods, but need further evaluation of compatible study designs, potential population bias, and cost-effectiveness.

Getting a colonoscopy at The Valley Hospital.

71 Background: Colorectal cancer (CRC) is the 3rd most common cancer in the U.S., yet it is preventable with evidence-based strategies such as early screening. The Valley Hospital (TVH) located in Bergen County NJ, is recognized for its high insured payer mix and median household income. According to the 2016 TVH Community Health Needs Assessment, only 71.4% of patients in TVH service area have had a CRC screening. The American Cancer Society National Colorectal Cancer Roundtable (NCCRT) campaigned to reach CRC screening rates of 80% and higher in communities across the nation. The Fast Track Screening Colonoscopy Program (FTSCP) at TVH was created to streamline the process of obtaining a screening colonoscopy and reach the NCCRT’s goal. Through the FTSCP, patients can omit the initial consultation with a gastroenterologist or colorectal surgeon. Patients are instead screened via a telephone call by a Physician Assistant (PA) or Advanced Practice Nurse (APN). The FTSCP is cost effective for patients as it potentially eliminates the initial consultation copayment and/or coinsurance. Methods: The purpose of the FTSCP is to achieve the NCCRT’s 80% goal of CRC screenings in TVH service area. An interdisciplinary team of gastroenterologists, colorectal surgeons, oncologists, anesthesiologists, and administration collaborated to create the FTSCP. A screening questionnaire was developed using the Lincoln Hospital in NYC’s existing criteria for patients who are eligible for a direct endoscopy referral. The questionnaire criteria ensures patients are safe to eliminate the initial consultation. A PA or APN determines the patients’ eligibility for the FTSCP over a screening telephone call. To qualify, patients cannot have significant medical comorbidities or exhibit signs or symptoms of CRC. If deemed eligible, the PA or APN sends a bowel preparation prescription to the patient’s pharmacy, reviews the instructions with them, and meets with them on the day of the procedure at TVH to perform a pre-procedural physical exam. To promote awareness and education of the FTSCP, multiple ongoing outreach events are held in the community. Patients also learn about the FTSCP through primary and specialty care referrals. Results: Since the inception of FTSCP in 2018, over 1300 patients have been screened for CRC. Additionally, adenocarcinomas, carcinoid tumors and tubular adenomas with high grade dysplasia have been detected. 394 tubular adenomas (30%) were identified and removed. In 2018, 59 patients were screened. The number of patients increased by 500% to 296 in 2023. The 2022 TVH Community Health Needs Assessment showed an increase to 79.6% of patients in TVH service area who have undergone CRC screening. Conclusions: The FTSCP at TVH is maximizing patient’s access to the prevention and timely screening for CRC. Additionally, TVH’s relocation from Ridgewood, NJ to Paramus, NJ offers further opportunities to educate a new community on CRC prevention.

Effectiveness of a mobile application for independent computerized cognitive training in patients with mild cognitive impairment: study protocol for the NeNaE Study, a randomized controlled trial

BackgroundMild cognitive impairment (MCI) involves cognitive decline beyond typical age-related changes, but without significant daily activity disruption. It can encompass various cognitive domains as the causes of MCI are diverse. MCI as well as frequent comorbid neuropsychiatric conditions like depression and anxiety affect individuals’ quality of life. Early interventions are essential, and computerized cognitive training (cCT) is an established treatment method. This paper presents the protocol for the NeuroNation MED Effectiveness Study, evaluating the self-administered mobile cCT intervention (“NeuroNation MED”) in individuals with MCI to assess training effects on cognitive domains, health competence, neuropsychiatric symptoms, psychological well-being, and the general application usability.MethodsThis study protocol presents a single-blinded multicenter randomized controlled trial that will be carried out in six study centers in Germany and Luxembourg. We included adults with MCI (existing F06.7 ICD-10-GM diagnosis and TICS ≥ 21 and ≤ 32). The intervention group will use a mobile, multi-domain cCT (“NeuroNation MED”) for 12 weeks. Meanwhile, the wait list control group will receive standard medical care or no care. The eligibility of volunteers will be determined through a telephone screening. After completion of the baseline examination, patients will be randomly assigned to one of the experimental conditions in a 2:1 ratio. In total, 286 participants will be included in this study. The primary outcome is the change of cognitive performance measured by the index score of the screening module of the Neuropsychological Assessment Battery. Secondary outcomes are changes in the Cognitive Failures Questionnaire, Hospital Anxiety and Depression Scale, Health-49, Health Literacy Questionnaire, among others. All of the primary and secondary outcomes will be assessed at baseline and after the 12-week post-allocation period. Furthermore, the intervention group will undergo an assessment of the System Usability Scale, and the training data of the NeuroNation MED application will be analyzed.DiscussionThis study aims to assess the effectiveness of a mobile self-administered cCT in enhancing cognitive abilities among individuals diagnosed with MCI. Should the findings confirm the effectiveness of the NeuroNation MED app, it may confer possible benefits for the care management of patients with MCI, owing to the accessibility, cost-effectiveness, and home-based setting it provides. Specifically, the cCT program could provide patients with personalized cognitive training, educational resources, and relaxation techniques, enabling participants to independently engage in cognitive training sessions at home without further supervision.Trial registrationGerman Clinical Trials Register DRKS00025133. Registered on November 5, 2021.

Community-associated Carbapenem-Resistant Organism Case Investigations in New York City, December 2020-May 2023

Epidemiology of carbapenem-resistant organisms (CRO) has focused on transmission in acute care hospital or long-term care facility (LTCF) settings. Few investigations have examined community-associated (CA)-CRO, with no consensus about common exposures. To explore possible exposures, the New York City (NYC) Department of Health and Mental Hygiene investigated suspected CA-CRO cases through routine surveillance among NYC residents with specimens collected during December 2020-May 2023. CA-CRO cases were defined as urine or skin specimens with bacterial cultures exhibiting carbapenem resistance, among individuals aged ≤70 years with no international travel, hospitalization, or LTCF stays within 12 months before specimen collection. Inclusion was determined by reviewing data from health information exchanges, when available electronic medical records, and telephone screening for those not excluded through record review. We identified 426 suspected cases for review, those not meeting the case definition were excluded; 44 individuals were not reached for screening. A preliminary questionnaire was fielded with 12 individuals and then refined to capture additional potential exposures. Analyses were completed with 23 individuals interviewed with the refined questionnaire. Of the 23, 70% were female; 39% were Hispanic, 17% Black, and 17% White; their median age was 60 years (range: 26-70 years). Further, 83% reported an outpatient appointment, 48% reported an outpatient procedure/surgery, and 9% reported having a hospitalized household member, all within 12 months before specimen collection; 26% had a urinary catheter or indwelling device within 2 days of specimen collection. Additionally, 30% reported taking antibiotics within 3 months of specimen collection, 52% denied taking antibiotics, 9% were unsure about antibiotic use, and 9% did not answer the question. Whole genome sequencing (WGS) was performed on 14 available isolates from CA-CRO cases by the NYC Public Health Laboratory or Wadsworth Center (WC), of which only 7 could be compared with isolates previously sequenced at WC (2017-2023). Six isolates were separated by >50 mutation events, suggesting no close genomic relationship. One isolate from 2021 was 11 mutation events from a 2018 isolate from the same individual, consistent with the expected evolutionary rate. While infrequent, CA-CRO cases occur in NYC. Outpatient healthcare, antibiotic use, and urinary catheters or indwelling devices were common self-reported exposures. Analyses were limited by screening non-response. Increased specimen availability for WGS could enhance investigation of CA-CRO exposure patterns. Health information exchange data were often incomplete and future surveillance could benefit from healthcare and public health partnerships and better documentation for more complete electronic medical histories.

Family expectations and demand for home-based videogaming therapy in children with cerebral palsy in Costa Rica: a mixed methods study

Purpose To understand the expectations and demand for a movement-tracking videogame (Bootle Blast) for home-based, upper limb (UL) rehabilitation among Costa Rican children with cerebral palsy (CP). Methods Data were collected via telephone screening (demand) and child-parent dyads Zoom interviews (expectations). Descriptive statistics and data transformation were used to report on demand success criteria (i.e., recruitment rate, having an appropriate screen and space to play, setting a weekly play time goal (PTG) ≥45 min, identifying one UL therapy goal). The DEPICT model for collaborative qualitative analysis was used in the thematic analysis of interview data. Results Fifteen dyads participated (1.6 ± 1 recruited/month). All had a flat-screen TV in a suitable location to play, were able to set a UL therapy goal, and established PTGs ranging from 45–120 min per week. Identified themes were: 1) Socio-cultural factors heighten demand, 2) Feelings of hope prevail for the intervention, and 3) Collaborative goal setting supports realistic expectations for Bootle Blast. Conclusions Dyads had positive and realistic expectations about implementing the proposed videogaming intervention. This study provides insights on tailoring a family-centered, therapy gaming intervention to improve access to motor rehabilitation for children with CP in rural/remote settings and low-middle income countries.

Limosilactobacillus reuteri 6475 and Prevention of Early Postmenopausal Bone Loss

Daily supplementation with the probiotic Limosilactobacillus reuteri ATCC PTA 6475 (L reuteri) vs placebo has previously been demonstrated to reduce bone loss in an estrogen deficiency mice model and older women, although the magnitude of the effect was small. We hypothesized that long-term treatment with L reuteri could result in clinically relevant skeletal benefits in postmenopausal osteoporosis. To evaluate whether daily supplementation with L reuteri vs placebo could reduce early postmenopausal bone loss and whether the effects remained or increased over time during 2 years of treatment. A double-blind, randomized, placebo-controlled clinical trial was conducted between December 4, 2019, and October 6, 2022, at a single center in Gothenburg, southwestern Sweden. Participants were recruited by online advertisements, and letters were sent to 10 062 women aged 50 to 60 years. Responding women (n = 752) underwent telephone screening, resulting in 292 women being invited to a screening visit. Of those who were screened, 239 women met all inclusion criteria and had no exclusion criteria. Capsules with L reuteri in 2 doses, 5 × 108 (low dose) or 5 × 109 (high dose) colony-forming units, taken twice daily or placebo were administered. All capsules also included cholecalciferol, 200 IU. The primary outcome was the relative change in tibia total volumetric bone mineral density (vBMD) over 2 years. Secondary outcomes included relative change in areal BMD of the lumbar spine and total hip, bone turnover markers C-terminal telopeptide cross-links of collagen type I and type I procollagen intact N-terminal propeptide, as well as tibia trabecular bone volume fraction and cortical vBMD. Both intention-to-treat and per-protocol analyses were conducted. A total of 239 postmenopausal women (median age, 55 [IQR, 53-56] years) were included. Tibia vBMD (primary outcome), hip and spine vBMD, and tibia cortical area and BMD decreased significantly in all groups, with no group-to-group differences (percent change tibia vBMD high dose vs placebo least-squares means, -0.08 [95 CI, -0.85 to 0.69] and low dose vs placebo least-squares means, -0.22 [95% CI, -0.99 to 0.55]). There were no significant treatment effects on any other predefined outcomes. A prespecified sensitivity analysis found a significant interaction between body mass index (BMI) and treatment effect at 2 years. No significant adverse effects were observed. In this randomized clinical trial of 239 early postmenopausal women, supplementation with L reuteri had no effect on bone loss or bone turnover over 2 years. The observed interaction between BMI and treatment effect warrants further investigation. ClinicalTrials.gov Identifier: NCT04169789.

Validation of scores from a telephone administered multiple sclerosis walking scale-12 in persons with multiple sclerosis

BackgroundThe Multiple Sclerosis Walking Scale-12 (MSWS-12) has typically been delivered through paper-and-pencil or computer-based administration. PurposeThis study examined the validity of inferences from scores derived via a telephone administration of the MSWS-12 applied as part of screening of participants with walking dysfunction into a clinical trial of exercise training in MS. MethodThe MSWS-12 was administered on two occasions separated by approximately 2 weeks through the telephone and then in-person (i.e., computer-based administration). Participants further completed the Patient Determined Disease Steps (PDDS) scale, timed 25-foot walk (T25FW), six-minute walk (6MW), Modified Fatigue Impact Scale (MFIS), and Multiple Sclerosis Impact Scale-29 (MSIS-29), and underwent a neurological exam for generating an expanded disability status scale (EDSS) score. The primary set of data (Full Sample) for analyses included all persons who passed the telephone screening for inclusion with MSWS-12 scores between 25 and 75 (N = 374). The secondary set of data (Truncated Sample) included only persons with MSWS-12 scores between 25 and 75 for both the telephone and computer administrations of the MSWS-12 (N = 248). ResultsThe results in the Full Sample indicated a difference in overall and item levels scores between the telephone and computer data collections, and the computer version had higher internal consistency and stronger unidimensionality. Nevertheless, MSWS-12 scores from both modes of administration had comparable correlations with the T25FW, 6MW, EDSS, PDDS, MFIS, and MSIS-29, but the correlation between the two MSWS-12 administrations did not approach unity. There was a systematic difference in scores between telephone and computer administrations across levels of walking dysfunction based on a Bland-Altman plot, and the difference was predicted by MFIS physical, 6MW, and EDSS scores. The comparison of results between the Full and Truncated Samples suggested that the primary analysis might have been influenced by the larger range of scores on the computer than telephone administrations of the MSWS-12. ConclusionThe telephone administration of the MSWS-12 provides an efficient and cost-effective measure of walking dysfunction in persons with MS.

The Effect of Physical Activity Levels on Cognitive Performance: Research in Portuguese Adolescents.

The literature unequivocally acknowledges the numerous health benefits that physical activity (PA) provides. However, in other variables, such as cognitive performance (CP), the PA characteristics required to elicit favorable benefits remain controversial, particularly among adolescents. The aim was to investigate the evolution of CP in adolescents over the school year, as well as the role of regular PA levels. The study included 366 adolescents (boys n = 154), between 12 and 20 years old (15.46 ± 1.63), from middle school (n = 123) and high school (n = 243). CP was assessed through a face-to-face interview employing the Cognitive Telephone Screening Instrument. The variation in CP (∆CP) was determined by the difference between the value of the final assessment (end of the school year) and the initial assessment (start of the school year). PA was assessed using accelerometry (ActiGraph GT3X+). The CP score improved from the initial to the final assessment (37.80 ± 9.26 vs. 40.45 ± 10.05) (t = -6.135; p < 0.001; Glass's Delta = 0.37. Multiple linear regression revealed that age (ß = -0.332; t = -4.255; p < 0.001) and high-intensity PA (ß = 0.283; t = 3.627; p < 0.001) accounted for 17.2% of the variation in ∆CP. CP improved significantly over the school year, emphasizing the significance of age and vigorous PA in ∆CP in adolescents.

Colorectal Cancer Screening After Sequential Outreach Components in a Demographically Diverse Cohort

Organized screening outreach can reduce differences in colorectal cancer (CRC) incidence and mortality between demographic subgroups. Outcomes associated with additional outreach, beyond universal outreach, are not well known. To compare CRC screening completion by race and ethnicity, age, and sex after universal automated outreach and additional personalized outreach. This observational cohort study included screening-eligible individuals aged 50 to 75 years assessed during 2019 in a community-based organized CRC screening program within the Kaiser Permanente Northern California (KPNC) integrated health care delivery setting. For KPNC members who are not up to date with screening by colonoscopy, each year the program first uses automated outreach (mailed prescreening notification postcards and fecal immunochemical test [FIT] kits, automated telephone calls, and postcard reminders), followed by personalized components for nonresponders (telephone calls, electronic messaging, and screening offers during office visits). Data analyses were performed between November 2021 and February 2023 and completed on February 5, 2023. Completed CRC screening via colonoscopy, sigmoidoscopy, or FIT. The primary outcome was the proportion of participants completing an FIT or colonoscopy after each component of the screening process. Differences across subgroups were assessed using the χ2 test. This study included 1 046 745 KPNC members. Their mean (SD) age was 61.1 (6.9) years, and more than half (53.2%) were women. A total of 0.4% of members were American Indian or Alaska Native, 18.5% were Asian, 7.2% were Black, 16.2% were Hispanic, 0.8% were Native Hawaiian or Other Pacific Islander, and 56.5% were White. Automated outreach significantly increased screening participation by 31.1%, 38.1%, 29.5%, 31.9%, 31.8%, and 34.5% among these groups, respectively; follow-up personalized outreach further significantly increased participation by absolute additional increases of 12.5%, 12.4%, 13.3%, 14.4%, 14.7%, and 11.2%, respectively (all differences P < .05 compared with White members). Overall screening coverage at the end of the yearly program differed significantly among members who were American Indian or Alaska Native (74.1%), Asian (83.5%), Black (77.7%), Hispanic (76.4%), or Native Hawaiian or Other Pacific Islander (74.4%) compared with White members (82.2%) (all differences P < .05 compared with White members). Screening completion was similar by sex; older members were substantially more likely to be up to date with CRC screening both before and at the end of the screening process. In this cohort study of a CRC screening program, sequential automated and personalized strategies each contributed to substantial increases in screening completion in all demographic groups. These findings suggest that such programs may potentially reduce differences in CRC screening completion across demographic groups.

Recruitment and baseline data of the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study: A randomized trial of a hearing loss intervention for reducing cognitive decline.

Hearing loss is highly prevalent among older adults and independently associated with cognitive decline. The Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study is a multicenter randomized control trial (partially nested within the infrastructure of an observational cohort study, the Atherosclerosis Risk in Communities [ARIC] study) to determine the efficacy of best-practice hearing treatment to reduce cognitive decline over 3 years. The goal of this paper is to describe the recruitment process and baseline results. Multiple strategies were used to recruit community-dwelling 70-84-year-old participants with adult-onset hearing loss who were free of substantial cognitive impairment from the parent ARIC study and de novo from the surrounding communities into the trial. Participants completed telephone screening, an in-person hearing, vision, and cognitive screening, and a comprehensive hearing assessment to determine eligibility. Over a 24-month period, 3004 telephone screenings resulted in 2344 in-person hearing, vision, and cognition screenings and 1294 comprehensive hearing screenings. Among 1102 eligible, 977 were randomized into the trial (median age = 76.4 years; 53.5% female; 87.8% White; 53.3% held a Bachelor's degree or higher). Participants recruited through the ARIC study were recruited much earlier and were less likely to report hearing loss interfered with their quality of life relative to participants recruited de novo from the community. Minor differences in baseline hearing or health characteristics were found by recruitment route (i.e., ARIC study or de novo) and by study site. The ACHIEVE study successfully completed enrollment over 2 years that met originally projected rates of recruitment. Substantial operational and scientific efficiencies during study startup were achieved through embedding this trial within the infrastructure of a longstanding and well-established observational study. The ACHIEVE study tests the effect of hearing intervention on cognitive decline.The study is partially nested within an existing cohort study.Over 2 years, 977 participants recruited and enrolled.Eligibility assessed by telephone and in-person for hearing, vision, and cognitive screening.The ACHIEVE study findings will have significant public health implications.

Clinical Pharmacy Services in Canadian Emergency Departments: A 2022 National Survey.

Support for the role of an emergency department (ED) clinical pharmacy team is evidence-based and recognized in numerous professional guidelines, yet previous literature suggests a low prevalence of ED clinical pharmacy services in Canadian hospitals. To update (from a survey conducted in 2013) the description and quantification of clinical pharmacy services in Canadian EDs. All Canadian hospitals with an ED and at least 50 acute care beds were contacted to identify the presence of dedicated ED pharmacy services (defined as at least 0.5 full-time equivalent [FTE] position). Three separate electronic surveys were distributed by email to ED pharmacy team members (if available), pharmacy managers (at hospitals without an ED pharmacy team), and ED managers (all hospitals). The surveys were completed between November 2021 and January 2022. Of the 254 hospitals identified, 117 (46%) had at least 0.5 FTE clinical pharmacy services in the ED (based on initial telephone screening). Of the 51 (44%) of 115 ED pharmacy team survey responses included in the analysis, 94% (48/51) had pharmacists and 55% (28/51) had pharmacy technicians. The majority of pharmacy managers and ED managers identified the need for ED pharmacy services where such services did not exist. Inadequate funding, competing priorities, and lack of training remain the most commonly reported barriers to providing this service. Personal safety concerns were reported by 20% (10/51) of respondents. Although the establishment of clinical pharmacy services in Canadian EDs has grown over the past 8 years, lack of funding and ED-specific training continue to limit this evidence-supported role in Canadian hospitals.

Comparing the effectiveness of a brief observational study protocol versus a telephone call for Alzheimer’s disease prevention trial prescreening

AbstractBackgroundMany Alzheimer’s disease (AD) clinical trials suffer from a high screen‐fail rate despite telephone pre‐screening, leading to a significant drain of time and resources. Thus, more efficient prescreening methods are required. Here, we examined whether prescreening through a brief on‐site observational study protocol could reduce clinical trial screen failure rate compared to telephone prescreening.MethodDe‐identified screening data from the AHEAD study (AD prevention trial) at the Brigham and Women’s Hospital (BWH) Center for Alzheimer Research and Treatment were used. Participants were referred for the AHEAD study screen either from a brief observational study protocol (Davis Memory and Aging Cohort [MAC]) or a telephone screen. MAC collects medical history, Mini‐Mental State Exam, Quick Dementia Rating System, and blood samples through a 60‐minute on‐site visit. Telephone screen uses medical history survey and Telephone Interview for Cognitive Status. We compared AHEAD screen failure rate due to (1) clinical exclusion criteria and (2) (for those with no clinical exclusion) amyloid‐β biomarker criteria (plasma, PET) between MAC and telephone screen referrals, using Fisher’s exact test.ResultThere was no significant difference in age, sex, race, or ethnicity between the MAC and Telephone prescreen groups (Table 1, MAC n = 61, telephone n = 55). The odds ratio (OR) for clinical screen‐fail for MAC (n = 9 out of 61, 15%) compared to telephone (n = 20 out of 55, 36%) was 0.31 (95% CI 0.12 to 0.80, p = 9.7×10−3). The OR for biomarker screen‐fail for MAC (n = 49 out of remaining 52, 94%) compared to telephone (n = 27 out of remaining 35, 77%) was 4.7 (95% CI 1.0 to 30.1, p = 0.024). The OR for randomization from MAC (n = 3 out of 61, 5%) compared to telephone (n = 8 out of 55, 15%) was not significantly different from 1 (p = 0.11).ConclusionOur findings show that, compared to a telephone screen, an on‐site prescreen assessing cognition, medical history, and venous access may prevent clinical trial screen fails attributable to clinical exclusion criteria and save participant/staff time and resources. However, an unexplained higher biomarker screen fail rate for the on‐site group offset this benefit, requiring further investigation.

Study protocol for a feasibility study of microinterventions in smartphone-based assessments to reduce depressive rumination

IntroductionDepression as well as suicidal ideation and behaviours share several precipitating and maintaining factors and are subject to the influence of overlapping constructs. One of these transdiagnostic constructs is rumination....

Innovative recruitment strategies for a multi‐domain lifestyle intervention trial (FINGER‐NL) via the Dutch Brain Research Registry

AbstractBackgroundFinding eligible participants for dementia prevention trials is challenging, resulting in prolonged recruitment periods, underpowered studies, and excessive costs. The Dutch Brain Research Registry (DBRR) is an online platform to facilitate recruitment of research participants. We evaluated different recruitment strategies with the ambition to optimize recruitment for the multi‐domain lifestyle intervention trial FINGER‐NL.MethodDBRR registrants were prescreened for FINGER‐NL based on available profile information. Potentially eligible registrants received an automatic study invitation. Those interested were contacted for additional telephonic screening and, if eligible, included in the trial. Five recruitment strategies within 2022 were executed with the goal to increase the number of DBRR registrants: 1) a paid Facebook‐campaign, 2) referral via (patient)‐organizations, 3) newspaper articles, 4) live‐events, and 5) national television appearance (W.F&amp;E.S.). Recruitment source was traced (online; UTM tags) and/or reported by the participant. For most recruitment strategies, we involved a nationally well‐known ambassador (E.S.) who advocates a healthy lifestyle to improve brain‐health (Figure 1). For each strategy, we described the number of individuals registered, eligible and included in FINGER‐NL. We calculated efficiency (%eligible/prescreened) as a reflection of the proportion of eligible participants reached, and effectiveness (%included/registered) as a reflection of the proportion of participants included in FINGER‐NLResultIn 2022, the DBRR recruited 11234 new registrants. The highest numbers of registrants and highest number of inclusions were reached with national television appearance and the Facebook‐campaign (Table 1). In particular, the Facebook advertisement with a lifestyle theme and well‐known ambassador outperformed all other advertisements in number of registrations (Figure 1). After initial prescreening, between 18‐35% of registrants were eligible. Most efficient were national television and the Facebook‐campaign. Between 4‐12% of new registrants were included in the trial. Most effective strategies were national television appearance and referrals via patient‐organizationsConclusionOur results show that mass‐media, i.e. tailor‐made Facebook‐campaigns, national television appearance and events, are efficient ways to reach large numbers of eligible participants, especially when well‐known ambassador(s) were included. Recruitment strategies with detailed information about in‐ and exclusion of the trial are most effective. The DBRR provides an efficient and effective recruitment and prescreening process for the FINGER‐NL trial.

A cognitive behavioural group treatment for somatic symptom disorder: a pilot study

BackgroundSomatic symptom disorder (SSD) presents challenges to the healthcare system, including frequent medical visits, lack of symptom relief experienced by individuals with this condition, high associated medical costs, and patient dissatisfaction. This study examined the utility of a novel, low-barrier, brief cognitive behavioural therapy (CBT) group intervention for individuals with SSD.MethodsParticipants were referred by their mental health providers or self-referral. Each participant underwent a telephone screen and in-person psychological and neuropsychological screen. Two cycles of the CBT-based group (n = 30), each consisting of six weekly two-hour sessions, were facilitated at a large outpatient mental healthcare facility in Ontario, Canada. The final sample consisted of 13 individuals of whom 11 completed the treatment. Clinical outcome measures were administered pre-, mid- and post-group, including the Generalized Anxiety Disorder–7, Perceived Stress Scale–4, Pain Self-Efficacy Questionnaire, Pain Disability Index, Revised Illness Perception Questionnaire, and sections of the Patient Health Questionnaire. Six healthcare utilization metrics were collected from electronic medical records at six months pre- and post-group. Paired samples t-tests were used to examine pre- to post-group differences in participants’ somatic symptoms, psychological functioning, health, and degree of healthcare utilization.ResultsWhen comparing pre- and post- group, we observed reductions in the mean scores for somatic symptom severity, depressive symptomatology, anxiety, perceived stress, and perceived disability related to pain. The change in depressive symptomatology yielded a small effect size (d = 0.30). Further, we observed downward trends across participants’ pre- to post-group healthcare utilization, with small effect sizes observed for hospital admission (d = 0.36), days admitted to hospital (d = 0.47), and inpatient consults (d = 0.42). Differences between pre- and post-group measures of somatic symptom severity, psychological functioning, health, or healthcare utilization did not reach significance.ConclusionsCurrent findings provide support for the potential effectiveness of an abbreviated CBT group for individuals with SSD in reducing psychiatric symptomatology. Further research is recommended, including randomized control trials, cost-benefit analyses, and comparisons between abbreviated versus longer-duration treatment programs for SSD.Trial registrationNot applicable.

4 Advancing the science of recruitment and retention in ADRD clinical research among Hispanics/Latinos

Objective:Inequity in Alzheimer’s disease and related dementias (ADRD) clinical research is severely hindering our progress towards a cure for all, while inflating national costs. ADRD alone is currently costing United States 321 billion dollars in 2022, projected to increase to 1 trillion by 2050. Alzheimer’s disease disproportionately impacts Black, Hispanic, Asian or Native Americans. Yet, ADRD clinical research to date has not included equitable number of participants from communities of color to be representative of the U.S. population. Hispanic/Latinos currently represent 1% of ADRD clinical trials’ samples despite representing 18% of the US population.Participants and Methods:In our previous outreach and recruitment study with the Human Connectome Project - Aging, we attained a 11.35% recruitment success rate of Hispanics/Latinos living in Los Angeles County Districts. We implemented a comprehensive Spanish-English bilingual, multi-method, multi-setting community-academic engagement, outreach, and recruitment protocol with a focus on brain health literary and ADRD biomarker research literacy.Results:Whereas community educational engagement and outreach was the most efficient and highest interest turn-out recruitment strategy, 61% of engaged and interested Hispanic/Latinos (50 years old and older) were automatically excluded during the telephone screening due to English-language proficiency/fluency. Highest enrollment success rate was from UCLA mailing list, clinical registries, and referrals. Hispanics/Latinos successfully recruited were bilingual or multilingual, 83% identified white as their racial background, 85% attained higher education, and 70% resided in middle-to-high income levels areas.Conclusions:Our results captured institutional barriers leading to a recruitment bias towards affluent Hispanics/Latinos with access to healthcare systems. Our applied science of recruitment and retention requires significant improvements in study design and methodology, tailored and targeted to communities’ socio-ecological context. It also requires the extrapolation of generalizable theoretically informed mechanisms of successful engagement, recruitment, and retention strategies for replication and/or modification in other settings/locations, and countries.

Insights for successful recruitment of people who actively use heroin to a pharmacotherapy trial: a case study

ABSTRACT Background This paper reports on recruiting strategies in a study which aimed to examine the mechanism of intranasal oxytocin on cue-induced opiate craving and attentional bias in males using heroin in addition to substitute opiates from four UK community drug treatment services. Methods Recruitment took place during and post-COVID-19 periods of social distancing and lockdowns. Caseworkers obtained consent to contact from interested service users before an initial telephone screen. People were then scheduled for in-person screens, typically within seven days of the initial telephone call. Subsequent visits took place within 30 days of the previous visit. Each visit lasted one hour and participants received one £20 voucher per completed visit. Results Thirty participants were randomized from 113 referrals. We were unable to contact 36% (n = 41) of people. Of those eligible to start the study (n = 44), 68% (n = 30) agreed to start the study, retaining 82% (n = 24) to completion. Factors which positively influenced recruitment were having a research presence on site, the cultivation of relationships and demonstrating respect and gratitude toward the participants. Conclusions These results support the feasibility of recruiting males currently using heroin in addition to substitute opiates utilizing a person-first approach with service users and staff.

Amyloid PET across the cognitive spectrum in former professional and college American football players: findings from the DIAGNOSE CTE Research Project

BackgroundExposure to repetitive head impacts (RHI) in American football players can lead to cognitive impairment and dementia due to neurodegenerative disease, particularly chronic traumatic encephalopathy (CTE). The pathognomonic lesion of CTE consists of perivascular aggregates of hyper-phosphorylated tau in neurons at the depths of cortical sulci. However, it is unclear whether exposure to RHI accelerates amyloid-β (Aβ) plaque formation and increases the risk for Alzheimer’s disease (AD). Although the Aβ neuritic plaques characteristic of AD are observed in a minority of later-stage CTE cases, diffuse plaques are more common. This study examined whether former professional and college American football players, including those with cognitive impairment and dementia, have elevated neuritic Aβ plaque density, as measured by florbetapir PET. Regardless of cognitive and functional status, elevated levels of florbetapir uptake were not expected.MethodsWe examined 237 men ages 45–74, including 119 former professional (PRO) and 60 former college (COL) football players, with and without cognitive impairment and dementia, and 58 same-age men without a history of contact sports or TBI (unexposed; UE) and who denied cognitive or behavioral symptoms at telephone screening. Former players were categorized into four diagnostic groups: normal cognition, subjective memory impairment, mild cognitive impairment, and dementia. Positive florbetapir PET was defined by cortical-cerebellar average SUVR of ≥ 1.10. Multivariable linear regression and analysis of covariance (ANCOVA) compared florbetapir average SUVR across diagnostic and exposure groups. Multivariable logistic regression compared florbetapir positivity. Race, education, age, and APOE4 were covariates.ResultsThere were no diagnostic group differences either in florbetapir average SUVR or the proportion of elevated florbetapir uptake. Average SUVR means also did not differ between exposure groups: PRO-COL (p = 0.94, 95% C.I. = [− 0.033, 0.025]), PRO-UE (p = 0.40, 95% C.I. = [− 0.010, 0.029]), COL-UE (p = 0.36, 95% CI = [0.0004, 0.039]). Florbetapir was not significantly associated with years of football exposure, cognition, or daily functioning.ConclusionsCognitive impairment in former American football players is not associated with PET imaging of neuritic Aβ plaque deposition. These findings are inconsistent with a neuropathological diagnosis of AD in individuals with substantial RHI exposure and have both clinical and medico-legal implications.Trial registrationNCT02798185.

A Comparison of Cognitive Performance, Depressive Symptoms, and Incidence of Falls in Brazilian Older Women with and without a Confirmed History of COVID-19.

The study aimed to compare cognitive performance, depressive symptoms, and the incidence of falls in Brazilian older women with and without a confirmed history of COVID-19. This cross-sectional study included 188 women (60-89 years), divided into two groups: one with a history of COVID-19 (n = 139), and one without any history of COVID-19 (n = 49). The instruments used were the Cognitive Telephone Screening Instrument (COGTEL) test battery, the Trail Making Test (TMT), the Geriatric Depression Scale (GDS-15), and the self-reported history of falls since the beginning of mandatory confinement. The higher the age, the higher the incidence of falls. The highest prevalence of falls (57.1%) occurred in the COVID-19 group (p = 0.001), the members of which also indicated a better cognitive performance in the COGTEL test (p = 0.017), TMT-B (p = 0.004), and ∆TMT (B-A) (p = 0.004). In turn, the depressive symptoms were more severe in the COVID-19 group (p < 0.001). We observed that COVID-19 infection without hospitalization did not affect the cognitive performance of older adult women. Future studies should be carried out to monitor the mental health of older adult Brazilian women. Moreover, regardless of their history of COVID-19, older adults should participate in a physical training program focused on preventing falls.

Low cognitive functioning and depressive symptoms in patients with rheumatoid arthritis and systemic sclerosis: a clinical study

BackgroundRecently, cognitive deficits occurring in rheumatic diseases have attracted scientific attention. Cognitive symptoms in patients with Rheumatoid Arthritis (RA) and Systemic Sclerosis (SSc) have not been thoroughly studied. This study aimed to assess cognitive function and its relationship with depressive symptoms in RA and SSc and compare it to mild neurocognitive disorder due to Alzheimer’s disease (MiND) and to individuals without cognitive impairment.MethodsCognitive function and depressive symptoms were tapped with the Cognitive Telephone Screening Instrument plus (COGTEL+), the Serial Seven Test (SST), the Mini-Mental State Examination (MMSE) and the Geriatric Depression scale-15 (GDS), respectively. Statistical analyses included between groups-, correlation- and regression analyses. Demographic characteristics were considered in the regression models.ResultsThe study included 30 individuals with RA, 24 with SSc, 26 adults without cognitive impairment and 33 individuals with MiND. Lower performance in verbal short-term memory, concentration/attention, verbal fluency and MMSE in patients with RA compared to individuals without cognitive impairment was detected. Of note, performance on verbal fluency, concentration/attention, inductive reasoning and MMSE was lower in RA compared to MiND. Individuals with SSc performed worse in verbal fluency and in MMSE in comparison to adults without cognitive deficits. Verbal fluency deficits in SSc exceeded that in MiND. Performance on MMSE, COGTEL+, prospective memory, working memory, verbal fluency and concentration/attention was related to GDS scores, which did not vary across the groups.ConclusionsPatients with RA and SSc encountered cognitive dysfunction, which partially pertains to depressive symptoms. Of note, the severity of cognitive dysfunction in many cases exceeded that of MiND.