Study Arms Research Articles

The TIRS trial: Enrollment procedures and baseline characterization of a pediatric cohort to quantify the epidemiologic impact of targeted indoor residual spraying on Aedes-borne viruses in Merida, Mexico.

Aedes mosquito-borne viruses (ABVs) place a substantial strain on public health resources in the Americas. Vector control of Aedes mosquitoes is an important public health strategy to decrease or prevent spread of ABVs. The ongoing Targeted Indoor Residual Spraying (TIRS) trial is an NIH-sponsored clinical trial to study the efficacy of a novel, proactive vector control technique to prevent dengue virus (DENV), Zika virus (ZIKV), and chikungunya virus (CHIKV) infections in the endemic city of Merida, Yucatan, Mexico. The primary outcome of the trial is laboratory-confirmed ABV infections in neighborhood clusters. Despite the difficulties caused by the COVID-19 pandemic, by early 2021 the TIRS trial completed enrollment of 4,792 children aged 2-15 years in 50 neighborhood clusters which were allocated to control or intervention arms via a covariate-constrained randomization algorithm. Here, we describe the makeup and ABV seroprevalence of participants and mosquito population characteristics in both arms before TIRS administration. Baseline surveys showed similar distribution of age, sex, and socio-economic factors between the arms. Serum samples from 1,399 children were tested by commercially available ELISAs for presence of anti-ABV antibodies. We found that 45.1% of children were seropositive for one or more flaviviruses and 24.0% were seropositive for CHIKV. Of the flavivirus-positive participants, most were positive for ZIKV-neutralizing antibodies by focus reduction neutralization testing which indicated a higher proportion of participants with previous ZIKV than DENV infections within the cohort. Both study arms had statistically similar seroprevalence for all viruses tested, similar socio-demographic compositions, similar levels of Ae. aegypti infestation, and similar observed mosquito susceptibility to insecticides. These findings describe a population with a high rate of previous exposure to ZIKV and lower titers of neutralizing antibodies against DENV serotypes, suggesting susceptibility to future outbreaks of flaviviruses is possible, but proactive vector control may mitigate these risks.

Intestinal-level anti-inflammatory bioactivities of whole wheat: Rationale, design, and methods of a randomized, controlled, crossover dietary trial in adults with prediabetes

Randomized controlled trials (RCT) demonstrate that whole wheat consumption improves glycemia. However, substantial inter-individual variation is often observed, highlighting that dietary whole grain recommendations may not support the health of all persons. The objective of this report is to describe the rationale and design of a planned RCT aimed at establishing the gut microbiota and metabolome signatures that predict whole wheat-mediated improvements in glucose tolerance in adults with prediabetes. It is hypothesized that a controlled diet containing wheat bread (WHEAT; 160 g/day) compared with refined bread (WHITE) will improve glucose tolerance in a gut microbiota-mediated manner. Biospecimens will be collected before and after each 2-week study arm. Testing for oral glucose tolerance and gastrointestinal permeability will be performed post-intervention. Assessments will include oral glucose tolerance (primary outcome) and secondary outcomes including gut microbiota, targeted and untargeted metabolomics of fecal and plasma samples, intestinal and host inflammatory responses, and intestinal permeability. WHEAT is predicted to alleviate glucose intolerance by shifting microbiota composition to increase short-chain fatty acid-producing bacteria while reducing populations implicated in intestinal inflammation, barrier dysfunction, and systemic endotoxemia. Further, benefits from WHEAT are anticipated to correlate with gut-level and systemic metabolomic responses that can help to explain the expected inter-individual variability in glucose tolerance. Thus, knowledge gained from integrating multi-omic responses associating with glucose tolerance could help to establish a precision nutrition-based framework that can alleviate cardiometabolic risk. This framework could inform novel dietary whole grain recommendations by enhancing our understanding of inter-individual responsiveness to whole grain consumption.

Lung Protective Mechanical Ventilation in Severe Acute Brain Injured Patients: A Multicenter, Randomized Clinical Trial (PROLABI).

Lung protective strategies using low tidal volumes and moderate positive end expiratory pressures (PEEP) are considered best practice in critical care, but interventional trials have never been conducted in acutely brain-injured patients due to concerns about carbon dioxide control and effect of PEEP on cerebral hemodynamic. In this multicenter, open-label, controlled clinical trial 190 adult acute brain injured patients were assigned to receive either a lung-protective or a conventional ventilatory strategy. The primary outcome was a composite endpoint of death, ventilator dependency and ARDS at day 28. Neurological outcome was assessed at intensive care unit discharge by Oxford Handicap Scale and at six months by Glasgow Outcome Scale. The two study arms had similar characteristics at baseline. In the lung-protective and conventional strategy groups, using an intention-to-treat approach, the composite outcome at 28 days was 61.5% and 45.3% (RR 1.35; 95%CI 1.03-1.79; p=0.025). Mortality was 28.9% and 15.1% (RR 1.91; 95%CI 1.06-3.42; p=0.02), ventilator dependency was 42.3% and 27.9% (RR 1.52; 95%CI 1.01-2.28; p=0.039), and incidence of ARDS was 30.8% and 22.1% (RR 1.39; 95%CI 0.85-2.27; p=0.179) respectively. The trial was stopped after enrolling 190 subjects because of termination of funding. In acutely brain-injured patients without ARDS a lung-protective ventilatory strategy as compared to a conventional strategy did not reduce mortality, percentage of patients weaned from mechanical ventilation, incidence of ARDS and was not beneficial in terms of neurological outcomes. Due to the early termination, these preliminary results require confirmation in larger trials. Clinical trial registration available at www. gov, ID: NCT01690819.

The “Latines Lideres En Salud (LaLiSa)” study: Rationale and design

BackgroundLatines suffer from breast cancer (BC), due to elevated biological and social determinants of health (SDOH) risks. This study compares the effects of different strategies on uptake of cancer genetic services, specifically hereditary cancer risk assessment, genetic counseling, and genetic testing, and risk-based BC care. Design/methodsIn Chicago, Illinois, Aim 1 participants are recruited from a federally qualified health center (FQHC) and community venues. For Aim 1, eligible participants: (1) are female; (2) are Latine; (3) are 30+ years old; (4) have personal or family history of BC or cancers with shared hereditary mutations; (5) have at least one SDOH risk; and (6) have not received any cancer genetic services. Participants are randomly assigned to different study arms. Both arms include phone-based sessions, FQHC-based navigation for SDOH, and low- or no-cost cancer genetic services. The educate sessions focus on risk assessment and prevention. The empower sessions focus on risk assessment and equip participants with the skills to share information about FQHC-based cancer genetic services. For Aim 2, eligible participants are: (1) female; (2) network members of Aim 1 participants; and (3) eligible for BC screening based on guidelines recommended by the American Cancer Society (ACS). Primary outcomes include uptake of any cancer genetic services. Analyses will also explore intervention differences by neighborhood context. DiscussionThis is one of the first trials focused on Latines' participation in cancer genetic services and risk-based BC care within the context of SDOH - which has major implications for equity in precision cancer prevention.

Thirty-five Years of Reporting of Sex and Race in Clinical Studies of U.S. FDA-Authorized Orthopaedic Devices.

At the U.S. Food and Drug Administration (FDA), the mission of the Center for Devices and Radiological Health (CDRH) is to ensure that all patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Although the CDRH has observed enrollment differences in some clinical trials, no systematic analysis has been conducted regarding enrollment differences in baseline demographics, to our knowledge. The CDRH has summarized information on study participants and their baseline demographics in public-facing documentation for all authorized medical devices that involved orthopaedic clinical studies from 1985 to 2020. Descriptive analyses and exploratory statistical testing have been conducted to investigate the reported percentages by sex and race compared with those reported in the U.S. National Census and the American Joint Replacement Registry (AJRR), respectively. We identified 94 submissions and corresponding combined clinical trials from 261 original clinical study arms with 34,193 participants. Most of the submissions reported age and sex, while only 36 submissions (38.3%) reported racial demographics. Among the 88 trials providing enrollment by sex, the female enrollment percentage ranged from 22.2% to 88.7%, with a mean of 55.0%. In the submissions that reported racial data (38.3%), White and Black patients had a mean enrollment of 89.2% (range, 64.8% to 98.7%) and 6.2% (range, 0.4% to 20.7%), respectively. The enrollment for other minority groups ranged from 0% to 3.0%. These clinical trials have shown numerically lower female representation (55.0%) but higher White representation (89.2%) than what has been reported in the AJRR. The other racial groups have participated much less than their corresponding percentages in the U.S. population, but they are similarly represented in the AJRR. The clinical trials supporting the FDA's authorization of orthopaedic devices had a wide range of sex and racial enrollments. It appears that female enrollment mirrors the percentage of women in the U.S. population. However, despite prior efforts, some racial groups are still underrepresented. The FDA has made a commitment to advancing health equity as part of the 2022-2025 Strategic Priorities of the CDRH. We hope that the results of this study will help health-care professionals make informed clinical decisions when using medical devices.

The Effectiveness of Compassion-focused Therapy on Patients with Bipolar Disorder, A Randomized Clinical Trial

Background: Multifarious complications are attributed to the bipolar disorder; while existing treatments are not yet fully effective. we evaluated effects of Compassion-focused therapy (CFT), an integrated psychological technique to include kinder thinking habit. Materials and Methods: This was a randomized trial (IRCT20211206053298N1) on a total of 26 individuals satisfying the diagnostic criteria for bipolar disorder who were allocated in two study arms by simple random allocation method, first receiving both CFT and conventional therapy (n=13) and seconds receiving traditional therapy alone (n=13). Compassion-focused therapy received consisted of ten sessions of CFT in conjunction with the customary treatment. Various psychological constructs, including self-compassion, self-criticism, shame, and distress associated with bipolar disorder were examined at beginning of study, after finishing the sessions, and 2 months later. Data analysis involved using repeated measures analysis of variance (RM-ANOVA) with statistically significant threshold of under 0.05 in SPSS V. 21. Results: There were no differences in educational level, gender, occupation, history of hospitalization, medical illness, and marital status between the study groups (P>0.05). There was a significant difference in trend of changes of studied variables. Intervention group showed a significant sharp decrease in shame (from baseline value of 12.76±4.38 to 4.46±7.26 two months later), self-criticism scores (26.61±6.57 at baseline and 14.76±5.74 at two-months period), and distress scores (21.0±2.29 at baseline to 11.75 ±2.00 at two-months period) from study beginning to final follow up that also had a more substantial decline than the control group (P<0.05). Both groups showed increased self-compassion score during the time with no differences among their increasing trend (P=0.725). Conclusion: The effect of CFT on the psychological treatment outcomes for individuals diagnosed with bipolar disorder appears to be significant, while it was not as effective on the self-compassion score. So, further studies would be helpful to draw a more precise conclusion.

Can pre-analytical procedures improve microbiological culture yield in patients with periprosthetic infections?

BackgroundThe detection of causative pathogens plays a crucial role in the diagnosis and targeted treatment of periprosthetic joint infections (PJI). While there have been improvements in analytic methods in the past, pre-analytical procedures have not yet been sufficiently investigated. The objective of this study was to compare the culture yield of four different pre-analytical procedures.MethodsPatients with perioperative diagnosis of PJI were included in a single center cross-sectional study (2021–2022). Tissue samples (n = 20) of each patient were randomly and equally distributed to each of the four study arms. Tissue samples were either send to the laboratory without culture medium (group A) or were transported in thioglycolate medium immediately after sampling at three different temperatures (room temperature, 4 °C, 37° for 24 h; group B-D). Culture media were investigated for growth on days 1, 3, 7, 12, 14. All organisms, the number of positive samples and the time to positivity were recorded and compared between the study arms. Single positive cultures were considered as contamination.ResultsIn total, 71 patients were included. The proportions of culture negative samples (10–15%) and polymicrobial infections (51–54%) were comparable between the four arms. Seven patients (10%) were culture-negative in group A, but showed growth in thioglycolate media (group B-D). Furthermore, 13% of patients showed growth in all groups, but additional organisms were cultured in thioglycolate. There was growth beyond day 7 of culturing only in thioglycolate, but not in group A. A storage temperature of 4 °C showed a longer time to positivity compared to the other groups (p < 0.001).ConclusionsPre-analytical storage of tissue samples in thioglycolate broth did not improve the culture yield and did not detect additional cases of infection compared to the standard (pre-analytical storage in sterile containers). However, including a thioglycolate medium to the sampling algorithm reduced the rate of culture-negative infections and helped to identify additional organisms.

Effects on patient activation of eHealth support in addition to standard care in patients after radical prostatectomy: Analysis of secondary outcome from a randomized controlled trial.

Prostate cancer is often treated with radical prostatectomy, but surgery can leave patients with side effects. Patients who actively take part in their rehabilitation have been shown to achieve better clinical outcomes. eHealth support has the potential to increase patient activation, but has rarely been evaluated in long-term randomized controlled trials. Therefore, we evaluated the effects on patient activation of eHealth support (electronic Patient Activation in Treatment at Home, ePATH) based on motivational theory. The aim was to investigate the effects of eHealth support on patient activation at 6 and 12 months after radical prostatectomy, compared with standard care alone, and associations with baseline patient activation and depression. A multicentre randomized controlled trial with two study arms was conducted. Men planned for radical prostatectomy at three county hospitals in southern Sweden were included and randomized to the intervention or control group. The effects of ePATH on the secondary outcome, patient activation, were evaluated for one year after surgery using the patient activation measure and analysed using a linear mixed model. The study included 170 men during 2018-2019. In the intervention group, 64% (53/83) used ePATH. The linear mixed model showed no significant differences between groups in patient activation [β -2.32, P .39; CI -7.64-3.00]. Baseline patient activation [β 0.65, P < .001; CI 0.40-0.91] and depression [β -0.86, P .03; CI -1.64- -0.07] statistically impacted patient activation scores over one year. ePATH had no impact on patient activation during long-term prostate cancer rehabilitation. However, patient activation at baseline and depression scores significantly influenced patient activation, underlining the need to assess these aspects in prostate cancer surgery rehabilitation. ISRCTN Registry ISRCTN18055968, (07/06/2018); https://www.isrctn.com/ISRCTN18055968; International Registered Report Identifier: RR2-10.2196/11625.

Assessing the Benefit of Two Detection Approaches in Screening COVID-19 Using SARS-CoV-2 Antigen Rapid Diagnostic Tests among Intercity Public Bus Travelers.

The movement of people contributes to the spread of COVID-19 between communities. Hence, we evaluated the feasibility, acceptability, and impact of offering intercity bus travelers testing prior to their departure. We conducted baseline and endline surveys to map COVID-19 prevention practices in travel agencies in western Cameroon. As interventions, buses were randomly assigned to three study arms: 1) offering systematic COVID-19 rapid diagnostic testing (RDT) to all passengers (arm A); 2) offering testing to suspected cases (arm B); or 3) no testing (arm C). All travelers were called 7-10 days after their trip to identify potential cases. Fifty-five (90.2%) of the 61 travel agencies that were reached consented to participate in a baseline survey. Although only 27 (49.1%) of the agencies implemented at least one of the recommended COVID-19 preventive measures, 39 (70.9%) agreed to host a testing station. Six agencies were selected, and 669 buses were enrolled, including 223, 224, and 222 in arms A, B, and C, respectively. A total of 31,484 departing passengers were approached and 9,594 (30.5%) agreed to participate: 1,177 (12.3%) in arm A, 4,086 (42.6%) in arm B, and 4,331 (45.1%) in arm C. In all, 1,731 tests were performed, including 1,177 in arm A and 554 in arm B. Fourteen (0.8%) tests were positive, and two participants (14.3%) agreed to postpone their travel. Offering testing with antigen RDTs in travel agencies is feasible and acceptable. One-third of passengers consented, and testing did not delay any travels. Although this approach can detect COVID-19 cases, actions are needed to increase the proportion of positive cases postponing their travels.

Exploring the feasibility of heart rate variability biofeedback for individuals with tetraplegia: A pilot clinical trial.

This study aimed to determine the feasibility of using commercially available heart rate variability (HRV) biofeedback training to improve physiological and self-reported stress and anxiety among adults with tetraplegia. HRV biofeedback teaches individuals to effectively modify their HRV levels in synchronization with their respiration rate and amplitude. Thirty participants with tetraplegia were enrolled and allocated into one of two study arms: biofeedback or control. The study was conducted remotely from June 2022 through February 2023. Participants in the biofeedback arm received eight HRV training sessions with physiological monitoring, while participants in the control arm received physiological monitoring only. Outcome measures included feasibility, percentage of time spent in the low-frequency range, the Depression Anxiety Stress Scale-21, the Subjective Units of Distress Scale, and the State-Trait Anxiety Inventory-Y Form. Feasibility was demonstrated with 100% completion of the protocol and no participant withdrawals due to adverse events. The biofeedback arm showed a greater percentage of time spent in the low-frequency range and reported greater improvement in anxiety from baseline to Session 8 on the Subjective Units of Distress Scale compared to the control arm. However, no differences were found between study arms on the Depression Anxiety Stress Scale-21 and State-Trait Anxiety Inventory-Y Form. This study demonstrated that a remotely delivered, self-administered HRV biofeedback intervention could feasibly be delivered to individuals with tetraplegia who report moderate-to-high levels of anxiety. Trends in the reduction of physiological and self-reported anxiety were observed. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

The Effect of Hemoadsorption with CytoSorb on Severe COVID-19 Complications

The aim of the study was to assess the effect of hemoadsorption with CytoSorb on the inflammatory response, respiratory failure, and mortality in patients with severe novel coronavirus infection.Materials and methods. A retrospective single-center cohort comparative study of hemoadsorbtion using the CytoSorb therapy included data from 124 COVID-19 ICU patients. Patients were divided into two groups: the study arm with hemoadsorption (group 1, N=93) and the control arm without hemoadsorption (group 2, N=31). Patients in group 1 had more severe respiratory failure at baseline, but were otherwise comparable to patients in group 2 in terms of clinical and demographic parameters.Results. After hemoadsorption, group 1 patients showed significant improvement in 9 of 13 monitored clinical, instrumental, and laboratory parameters: fever (P=0.005), lactate dehydrogenase (LDH) (P&lt;0.001), C-reactive protein (CRP) (P&lt;0.001), and IL-6 (P&lt;0.001) levels, as well as an increase in SpO₂/FiO₂ ratio (P=0.041), leukocyte count (P&lt;0.001) and lymphocyte count (P=0.003), as well as no significant changes in SOFA score (P=0.068). The only improvement seen in group 2 patients was a reduction in fever (P=0.003). Other significant changes in group 2 were unfavorable, such as a decrease in SpO₂/FiO₂ ratio (P=0.002), an increase in inspiratory oxygen fraction FiO₂ (P=0.001), leukocyte count (P&lt;0.05), LDH (P=0.038), procalcitonin (P&lt;0.001), and IL-6 (P=0.005), as well as an increase in SOFA score from 3.0 to 7.0 (95%CI, 3.0–9.0) (P=0.001). The all-cause hospital mortality rate was 37,63% in group 1 and 74.20% in group 2.Conclusion. The use of hemoadsorption with CytoSorb as a pathogenetic therapy targeting the hyperinflammatory response in the management algorithm of ICU patients with severe COVID-19 complications resulted in resolution of the inflammatory response and respiratory failure, as well as a significant reduction in mortality.

Evaluating fentanyl test strips as a harm reduction strategy in rural and urban counties: study protocol for a randomized controlled trial

BackgroundOpioid-related fatalities are a leading cause of death in Ohio and nationally, with an increasing number of overdoses attributable to fentanyl. Rapid fentanyl test strips can identify fentanyl and some fentanyl analogs in urine samples and are increasingly being used to check illicit drugs for fentanyl before they are used. Fentanyl test strips are a promising harm reduction strategy; however, little is known about the real-world acceptability and impact of fentanyl test strip use. This study investigates fentanyl test strip distribution and education as a harm reduction strategy to prevent overdoses among people who use drugs.MethodsThe research team will recruit 2400 individuals ≥ 18 years with self-reported use of illicit drugs or drugs purchased on the street within the past 6 months. Recruitment will occur at opioid overdose education and naloxone distribution programs in 16 urban and 12 rural Ohio counties. Participating sites will be randomized at the county level to the intervention or non-intervention study arm. A brief fentanyl test strip educational intervention and fentanyl test strips will be provided to participants recruited from sites in the intervention arm. These participants will be eligible to receive additional fentanyl test strips for 2 years post-enrollment. Participants recruited from sites in the non-intervention arm will not receive fentanyl test strip education or fentanyl test strips. All participants will be followed for 2 years post-enrollment using biweekly, quarterly, and 6-month surveys. Primary outcomes include (1) identification of perceived barriers and facilitating factors associated with incorporating fentanyl test strip education and distribution into opioid overdose education and naloxone distribution programs; (2) differences in knowledge and self-efficacy regarding how to test drugs for fentanyl and strategies for reducing overdose risk between the intervention and non-intervention groups; and (3) differences in non-fatal and fatal overdose rates between the intervention and non-intervention groups.DiscussionFindings from this cluster randomized controlled trial will contribute valuable information about the feasibility, acceptability, and impact of integrating fentanyl test strip drug checking in rural and urban communities in Ohio and help guide future overdose prevention interventions.Trial registrationClinicalTrials.gov NCT05463341. Registered on July 19, 2022. https://clinicaltrials.gov/study/NCT05463341

Comparative Analysis of ERCP and PTBD for Biliary Interventions for Readmission Rates and Patient Outcomes.

Endoscopic retrograde cholangiopancreatography (ERCP) and percutaneous transhepatic biliary drainage (PTBD) are interventions used to relieve biliary obstruction. The utility of ERCP compared with PTBD is not fully understood from a utilization outcome standpoint. Our study compares readmission rates and hospitalization outcomes in ERCP and PTBD. Using the National Readmission Database (NRD) 2016 to 2020, we identified all patients with an ERCP or PTBD completed during admission. The study cohort was first analyzed by 3 weighted study arms including those admitted with cholangitis, biliary/pancreatic malignancy, and choledocholithiasis. Second, we analyzed the cohort by a 1:1, unweighted propensity match. The primary outcome was 30 day, 90 day, and 6 month readmission. Secondary outcomes were readmission/overall mortality, cost, and length of stay. Outcomes were analyzed using multivariate analysis. A total of 621,735 admissions were identified associated with 589,796 ERCP and 31,939 PTBD. In the propensity matched cohort, PTBD had a higher readmission rate at 30 days (20.38% vs. 13.71% P<0.0001), 90 days (14.63% vs. 13.14%, P<0.0001) but lower rate at 6 months (8.50% vs. 9.67%, P=0.0003). Secondary outcomes included increased PTBD-associated hospital length of stay (9.01d vs. 6.74d, P<0.0001), hospitalization cost ($106,947.97 vs. $97,602.25, P<0.0001), and overall mortality (6.86% vs. 4.35%, P<0.0001). No major differences were found for mortality among readmissions at 30 days (7.19% vs. 6.88%, P=0.5382), 90 day (6.82% vs. 6.51%, P=0.5612), and 6 months (5.08% vs. 5.91%, P=0.1744). ERCP demonstrated superior results compared with PTBD for readmission rates, length of stay and overall mortality. For failed ERCP cases, emerging data for Endoscopic ultrasound guided-biliary drainage (EUS-BD) offers potential over PTBD and may provide additional options for the future in tertiary referral centers with experience.

Early Intervention after Rape to prevent post-traumatic stress symptoms (the EIR-study): an internal pilot study of a randomized controlled trial

BackgroundRape is one of the trauma incidents with the highest risk of subsequent post-traumatic stress disorder. Early interventions, such as prolonged exposure therapy (PE), have shown promise in preventing PTSD following a sexual assault. The primary objective of this internal pilot trial was to examine the feasibility of the EIR study protocol, which used modified prolonged exposure therapy (mPE) as a preventive intervention after rape.MethodsThis parallel two-arm clinical pilot study involved three sexual assault centers (SACs) in Trondheim, Oslo, and Vestfold, with data collected between June 2022 and March 2023. Women seeking assistance at one of these three SACs within 72 h after rape or attempted rape received acute medical treatment and forensic examinations. Women who wanted further psychosocial treatment were, if eligible and consenting, recruited to complete baseline assessments and a clinical interview before being randomized to one of two study arms. The intervention group prescribed up to five sessions of modified PE (mPE) in addition to treatment as usual (TAU), starting within the first 14 days after the rape incident, followed by weekly sessions. The other group received TAU.The present pilot evaluation is based on 22 participants, i.e., nine mPE + TAU and 13 TAU alone. Primary outcomes were predefined progression criteria regarding recruitment, retention, intervention implementation, a harm reporting system, and applying biological measurements and actigraphy.ResultsDuring the 6-month recruitment period, 235 women visited the three SACs. After eligibility screening and consent, 22 (9.4%) women were randomized. Three months later, 14 (63.6%) participants completed the final assessments. Intervention implementation was successful using trained SAC personnel to deliver mPE. The harm reporting system was used according to the study’s plan, and adverse and serious adverse events were detected during the trial. The biological measurements and actigraphy had substantial missing data but were still considered usable for statistical analyses.ConclusionIt may be feasible to conduct a full-scale RCT of early intervention after rape by comparing mPE + TAU to TAU alone. Minor design refinements were made to the protocol to enhance the main study outcome.Trial registrationClinicalTrials.gov Identifier: NCT05489133. Registered on 15 July 2022, retrospectively.

The Effect of Meal Frequency and Glycemic Index During the Night Shift on Alertness, Hunger, and Gastrointestinal Complaints in Female Health Care Workers—A Two-Armed Randomized Crossover Trial

BackgroundNutrition strategies for night-shift workers could optimize alertness and minimize hunger and reduce gastrointestinal complaints, enhancing safety and well-being. ObjectivesThis study aimed to investigate the effects of 1 or 3 small meals, with either low or high glycemic index (GI), compared with no meal, on alertness, hunger, and gastrointestinal complaints during the night shift. MethodsFifty-one female health care workers, aged 18 to 61 Y, participated in a 2-armed randomized crossover design. In 1 study arm, participants received 1 yogurt meal during the night shift, AND in the other, they received 3. Each study arm involved 3 intervention periods during night shifts, with participants consuming yogurt with low GI (1LGI or 3LGI) OR high GI (1HGI or 3HGI) carbohydrates, or no meal (0NGI). Objective alertness was assessed using a validated brief psychomotor vigilance task (PVT-B), subjective alertness with the Samn–Perelli scale, and hunger and gastrointestinal complaints through questionnaires. ResultsParticipants in the 1LGI (β: −4.6; 95% CI: 0.0, 9.3) and 3LGI (β: −3.4; 95% CI: 0.0, 6.8) conditions had fewer lapses during the PVT-B than those in the 3HGI condition. No differences were found between meal conditions for median and reciprocal reaction time or subjective alertness. All 4 conditions reported less hunger (β: from −0.6 to −1.2) compared with no meal. The 3LGI condition resulted in more rumbling intestines than the 3HGI (β: 1.1; 95% CI: 0.4, 1.7) and 0NGI (β: 0.74; 95% CI: 0.11, 1.37) conditions. ConclusionsOur study suggests that consuming 3 small low GI meals during the night shift helps maintain alertness and reduces lapses compared with 3 high GI meals. It also minimizes hunger but may cause mild gastrointestinal complaints.This trial was registered at International Clinical Trial Registry (https://trialsearch.who.int/Trial2.aspx?TrialID%3dNL-OMON25574).

Contraception use and changes in young women with newly diagnosed breast cancer

To evaluate contraception use and change among young women with early breast cancer. Secondary analysis of a cluster randomized trial. Multi-institutional. Patients with newly diagnosed breast cancer age ≤45 years enrolled from 54 US oncology practices. Sites were randomly assigned to the Young Women's Intervention, an educational intervention for young women with newly diagnosed breast cancer and their oncologists addressing issues specific to this population, including contraception, or a contact-time control physical activity intervention. Participants completed surveys in follow-up, including a 3-month survey regarding contraceptive practices before and after diagnosis. Outcomes of interest included young women's contraceptive use and methods before breast cancer diagnosis and 3 months after study enrollment. Logistic regression models assessed factors associated with use of less than highly effective contraceptive methods categorized according to World Health Organization effectiveness tiers and changes in contraceptive methods. Of 312 women included, 258 (83%) reported contraceptive use before breast cancer diagnosis, and 275 (88%) reported contraceptive use after diagnosis. Use of highly effective methods (e.g., vasectomy, non-hormonal intrauterine devices) increased from 39% before diagnosis to 52% after diagnosis. Use of moderately effective methods (e.g., hormonal methods) decreased from 22% before diagnosis to 3% after diagnosis. Use of less effective methods (e.g., condoms, withdrawal) increased from 22% before diagnosis to 34% after diagnosis. On multivariable analysis, factors associated with using less than highly effective contraception after diagnosis included desire for additional children (odds ratio [OR], 6.33; 95% confidence interval [CI], 3.76-10.66) and discussing contraception with a provider (OR, 1.96; 95% CI, 1.12-3.40). After breast cancer diagnosis, 207 patients (66%) reported no change in contraceptive methods. On multivariable analysis, factors associated with contraceptive method change after diagnosis included age <35 years (OR, 2.96; 95% CI, 1.57-5.58) and provider discussion (OR, 3.59; 95% CI, 1.91-6.78). There was no association in either analysis with study arm. Although most patients used contraception after breast cancer diagnosis, nearly half reported using less than highly effective contraceptive methods with higher failure rates, highlighting the need for early and improved contraceptive counseling for young women with breast cancer. NCT01647607.

Abstract 26: An Effective mHealth Intervention to Close the Guideline-to-Practice Gap in Hypertension Treatment: mGlide RCT

Background: Suboptimal HTN control is a widespread problem particularly among minorities and socioeconomically disadvantaged groups. Objective: To determine if a mobile health (mHealth) intervention facilitating an active partnership between inter-professional care teams (including pharmacists) and patients improves HTN control in patients with uncontrolled HTN. Methods: mGlide is an NIH-funded, 2-arm RCT evaluating HTN control between a mHealth intervention (mGlide) vs. state-of-clinical-care (comparison) groups using a PROBE (Prospective Randomized Open Blinded End-point) design. Table 1 shows intervention components. High CVD risk patients with uncontrolled HTN identified by EHR query were randomized 1:1 to either mGlide or to comparison for a 6-month intervention followed by a 6-month observation period. Recruitment sites include primary care clinics and specialty stroke service in an integrated health system, community clinics (CC) and federally qualified health centers (FQHC). The FQHC and CC serve low income and minority (Hmong and Latino) patients. The primary aim tested clinical effectiveness of mGlide in reducing SBP at 6 months. Secondary outcomes include resource utilization, adverse events and medication side-effects. Results: Recruitment started in 2019. N=395 participants enrolled by August 2023. The pandemic impacted enrollment; however enrollment recovered after vaccine availability (Figure). Primary outcome was available in March 2024 on everyone except in those lost to follow-up (n=38; 9.6%). We used multiple imputation for those missing 6 month SBP. Baseline mean SBP was 143.2 vs. 143.6 mm Hg in mGlide vs. comparison. The intervention led to better HTN control (Table 2). Mean 6-month SBP was 128.1 (mGlide) vs. 134 mm Hg (comparison). Adjusting for baseline SBP and study strata, 6-month mean SBP was 5.7 mm Hg (95% CI 2.9-8.4; p = 0.0001) lower in mGlide vs. comparison. The odds of HTN control defined as “alive and SBP &lt; 130 mm Hg”, was 60% higher in the mGlide arm (OR 1.6; 95% CI 1.03-2.48; p=0.035). There was one death in each study arm. The mGlide arm had fewer ER visits (16% vs. 25%; p=0.024), fewer hospitalizations (7% vs. 13%; p=0.044) and more medication side effects (39% vs. 26%, p=0.008). Conclusions: An inexpensive mHealth intervention that used the patient’s own phone (Table 1) was implemented in diverse health systems and significantly reduced SBP and was associated with less resource utilization at 6 months (Table 2).

Home visits versus fixed-site care by community health workers and child survival: a cluster-randomized trial, Mali.

To test the effect of proactive home visits by trained community health workers (CHWs) on child survival. We conducted a two arm, parallel, unmasked cluster-randomized trial in 137 village-clusters in rural Mali. From February 2017 to January 2020, 31 761 children enrolled at the trial start or at birth. Village-clusters received either primary care services by CHWs providing regular home visits (intervention) or by CHWs providing care at a fixed site (control). In both arms, user fees were removed and primary health centres received staffing and infrastructure improvements before trial start. Using lifetime birth histories from women aged 15-49 years surveyed annually, we estimated incidence rate ratios (IRR) for intention-to-treat and per-protocol effects on under-five mortality using Poisson regression models. Over three years, we observed 52 970 person-years (27 332 in intervention arm; 25 638 in control arm). During the trial, 909 children in the intervention arm and 827 children in the control arm died. The under-five mortality rate declined from 142.8 (95% CI: 133.3-152.9) to 56.7 (95% CI: 48.5-66.4) deaths per 1000 live births in the intervention arm; and from 154.3 (95% CI: 144.3-164.9) to 54.9 (95% CI: 45.2-64.5) deaths per 1000 live births in the control arm. Intention-to-treat (IRR: 1.02; 95% CI: 0.88-1.19) and per-protocol estimates (IRR: 1.01; 95% CI: 0.87-1.18) showed no difference between study arms. Though proactive home visits did not reduce under-five mortality, system-strengthening measures may have contributed to the decline in under-five mortality in both arms.

The Odyssey of HOMER: Comparative Effectiveness Research on Medication for Opioid Use Disorder During the COVID-19 Pandemic.

The usual challenges of conducting primary care research, including randomized trials, have been exacerbated, and new ones identified, during the COVID-19 pandemic. HOMER (Home versus Office for Medication Enhanced Recovery; subsequently, Comparing Home, Office, and Telehealth Induction for Medication Enhanced Recovery) is a pragmatic, comparative-effectiveness research trial that aims to answer a key question from patients and clinicians: What is the best setting in which to start treatment with buprenorphine for opioid use disorder for this patient at this time? In this article, we describe the difficult journey to find the answer. The HOMER study began as a randomized trial comparing treatment outcomes in patients starting treatment with buprenorphine via induction at home (unobserved) vs in the office (observed, synchronous). The study aimed to enroll 1,000 participants from 100 diverse primary care practices associated with the State Networks of Colorado Ambulatory Practices and Partners and the American Academy of Family Physicians National Research Network. The research team faced unexpected challenges related to the COVID-19 pandemic and dramatic changes in the opioid epidemic. These challenges required changes to the study design, protocol, recruitment intensity, and funding conversations, as well as patience. As this is a participatory research study, we sought, documented, and responded to practice and patient requests for adaptations. Changes included adding a third study arm using telehealth induction (observed via telephone or video, synchronous) and switching to a comprehensive cohort design to answer meaningful patient-centered research questions. Using a narrative approach based on the Greek myth of Homer, we describe here the challenges and adaptations that have provided the opportunity for HOMER to thrive and find the way home. These clinical trial strategies may apply to other studies faced with similar cultural and extreme circumstances.

Phase-Amplitude Coupling in Theta and Beta Bands: A Potential Electrophysiological Marker for Obstructive Sleep Apnea.

Phase-amplitude coupling (PAC) between the phase of low-frequency signals and the amplitude of high-frequency activities plays many physiological roles and is involved in the pathological processed of various neurological disorders. However, how low-frequency and high-frequency neural oscillations or information synchronization activities change under chronic central hypoxia in OSA patients and whether these changes are closely associated with OSA remains largely unexplored. This study arm to elucidate the long-term consequences of OSA-related oxygen deprivation on central nervous system function. : We screened 521 patients who were clinically suspected of having OSA at our neurology and sleep centers. Through polysomnography (PSG) and other clinical examinations, 103 patients were ultimately included in the study and classified into mild, moderate, and severe OSA groups based on the severity of hypoxia determined by PSG. We utilized the phase-amplitude coupling (PAC) method to analyze the modulation index (MI) trends between different frequency bands during NREM (N1/N2/N3), REM, and wakefulness stages in OSA patients with varying severity levels. We also examined the correlation between the MI index and OSA hypoxia indices. Apart from reduced N2 sleep duration and increased microarousal index, the sleep architecture remained largely unchanged among OSA patients with varying severity levels. Compared to the mild OSA group, patients with moderate and severe OSA exhibited higher MI values of PAC in the low-frequency theta phase and high-frequency beta amplitude in the frontal and occipital regions during N1 sleep and wakefulness. No significant differences in the MI of phase-amplitude coupling were observed during N2/3 and REM sleep. Moreover, the MI of phase-amplitude coupling in theta and beta bands positively correlated with hypoxia-related indices, including the apnea-hypopnea index (AHI) and oxygenation desaturation index (ODI), and the percentage of oxygen saturation below 90% (SaO2<90%). OSA patients demonstrated increased MI values of theta phase and beta amplitude in the frontal and occipital regions during N1 sleep and wakefulness. This suggests that cortical coupling is prevalent and exhibits sleep-stage-specific patterns in OSA. Theta-beta PAC during N1 and wakefulness was positively correlated with hypoxia-related indices, suggesting a potential relationship between these neural oscillations and OSA severity. The present study provides new insights into the relationship between neural oscillations and respiratory hypoxia in OSA patients.