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Follow‐up
acute respiratory illness, ARI
Following antiviral receipt, influenza‐positive participants were asked to return to the kiosk for symptom surveys and nasal swab collection 2–3 and 5–7 days after diagnosis (Figure (A) Study design overview including participant‐level study flow of the test‐and‐treat strategy from 11/15/19 to 4/30/21. (B) Total number...
PMC9835442
Impact of the COVID‐19 pandemic on study protocol
ARI
VIRUS, RECRUITMENT, APPENDIX, INFLUENZA
In response to SARS‐CoV‐2 community transmission in WA, study Year 1's intervention was paused on 4/1/2020. Study Year 2 recommenced on 11/2/20 but was terminated early on 4/1/2021 due to operational futility based on minimal influenza activity in King County, WA. During the second year of the study, 5 of the 9 shelter...
PMC9835442
UW laboratory testing
INFLUENZA A, INFLUENZA
For samples that were sent to the laboratory, total nucleic acids were extracted using the Magna Pure 96 kit (Roche) and tested by TaqMan OpenArray RT‐PCR (Thermo) for multiple viral pathogens, including influenza A (H3 and H1 hemagglutinin subtypes) and influenza B. OpenArray relative threshold (CRT) values were used ...
PMC9835442
Outcomes and statistical analyses
INFLUENZA
All data in this analysis are presented by participant encounter, defined as each time an eligible individual provided a nasal swab and completed a survey with study staff. We used descriptive statistics to evaluate the sociodemographic and clinical characteristics at baseline in control and intervention periods for st...
PMC9835442
Primary objective: Effects on reducing secondary spread of influenza virus
cough, ILI, sore throat, fever
SORE THROAT, VIRUS, VIRUS INFECTION, INFLUENZA
The primary endpoint was monthly number of influenza‐positive samples in the control versus intervention periods among ARI‐participant encounters. The predictor of interest was test‐and‐treat at the shelter/cluster‐month level (i.e., intervention vs. control periods). Shelters were analyzed with an intent‐to‐treat (ITT...
PMC9835442
Secondary objective A: Assess feasibility of test‐and‐treat strategy for influenza in shelters
INFLUENZA
Feasibility of implementation of point‐of‐care influenza molecular testing was measured as the time between symptom onset until diagnosis through rapid test or laboratory test. Feasibility of implementation of antiviral treatment was measured as the time between symptom onset until initiation of antiviral treatment. Ad...
PMC9835442
Secondary objective B: Characterize influenza transmission
INFLUENZA
To better understand the relationship among the influenza cases detected by this study and between these cases and cases with a viral genomic sequence publicly available in the GISAID database, we attempted sequencing on all influenza‐positive samples from Year 1 with viral loads > ~50,000 genomic copies/ml. We were ab...
PMC9835442
RESULTS
PMC9835442
Study population and demographics
respiratory illness, ARI
INFLUENZA
Overall, we observed 1283 ARI encounters (1159 from Year 1 and 124 from Year 2) from 668 unique participants who met eligibility criteria. Of these, 514 and 769 encounters occurred during the control and intervention periods, respectively. The median age of participants was 45 years (interquartile range [IQR]: 24), and...
PMC9835442
Clinical characteristics of ARI encounters
sore throat, Chronic obstructive pulmonary disorder, fever, rhinorrhea, respiratory illness, ARI, emphysema, cough, asthma, Fever
SORE THROAT, REACTIVE AIRWAY DISEASE, EMPHYSEMA, ASTHMA, INFLUENZA
The most common symptoms reported were rhinorrhea (76.9%) and cough (72.3%) (Table Baseline sociodemographic and clinical characteristics of ARI‐participant encounters, by laboratory multiplex assay‐confirmed influenza result and rapid influenza molecular test result, 2019–2020 and 2020–2021 influenza seasonsAbbreviati...
PMC9835442
Influenza detection and intervention effect on reducing secondary spread of influenza virus
respiratory illness, infection, ARI, infections
VIRUS INFECTION, INFECTIONS, INFECTION, INFLUENZA A, INFLUENZA
Among all ARI‐participant encounters, 51 (4.0%) influenza virus infections (A = 15; B = 37) were identified through RT‐PCR. Of the influenza A subtypes, A(H1N1)pdm09 predominated (93.3%). Most infections were identified among participants 18–59 years (54.9%; Table Among the 269 ARI encounters that were eligible for the...
PMC9835442
Feasibility of influenza test‐and‐treat strategy
infections
ADVERSE EVENTS, INFECTIONS
Of all ARI‐participant encounters, 37.4% reported symptom onset < 48 h (Table All 21 positives were treated with an antiviral, including 12 with oseltamivir and 9 with baloxavir; 38% of those treated were <5 years old. Of the 51 symptomatic infections identified through RT‐PCR, 64.7% had symptom onset < 48 h of specime...
PMC9835442
Genomics
INFLUENZA A, INFLUENZA B, INFLUENZA
All seven full genome sequences generated for the influenza A‐positive samples from three different shelters were identified as A(H1N1)pdm09 viruses. We generated a maximum likelihood phylogenetic tree containing these seven samples along with all A(H1N1)pdm09 genomes deposited in GISAID that were collected in WA from ...
PMC9835442
DISCUSSION
illness, ARI, infections, infection, transiency
VIRUS, VIRUS INFECTION, SPECIFIC VIRAL INFECTIONS, INFECTIONS, INFECTION, SECONDARY, APPENDIX, INFLUENZA
This study assessed the feasibility and impact of an on‐site test‐and‐treat intervention for influenza among persons experiencing homelessness in a congregate setting. Although the study was limited by operational futility from a near absence of influenza virus circulation in WA in Year 2,Using on‐site surveillance, we...
PMC9835442
CONCLUSION
INFLUENZA EPIDEMIC, VIRUS INFECTION, INFLUENZA
Our findings establish the feasibility of an on‐site influenza test‐and‐treat strategy in shelters that has the potential to be applied during influenza epidemics and pandemics. Our genomic data suggest that intra‐shelter spread of influenza viruses is common and is responsible for a large proportion of symptomatic inf...
PMC9835442
CONFLICTS OF INTEREST
Dr. Chu reported consulting with Ellume, Pfizer, The Bill and Melinda Gates Foundation, GlaxoSmithKline, and Merck. She has received research funding from Sanofi Pasteur, and support and reagents from Ellume and Cepheid outside of the submitted work. Dr. Englund reported research support from Merck, AstraZeneca, Pfizer...
PMC9835442
AUTHOR CONTRIBUTIONS
PMC9835442
ETHICS STATEMENT
The University of Washington Institutional Review Board approved this study. All participants provided informed consent and/or assent.
PMC9835442
PEER REVIEW
The peer review history for this article is available at
PMC9835442
Supporting information
Click here for additional data file.
PMC9835442
ACKNOWLEDGMENTS
FLU
We would like to acknowledge the homeless shelter staff, program managers, and all the participants who made this work possible. We would also like to acknowledge the Seattle Flu Study co‐investigators and the BAT‐Lab Pathogen Detection Lab Team for their contributions to this project.
PMC9835442
DATA AVAILABILITY STATEMENT
Patient‐level data and statistical code are available upon request from the corresponding author at
PMC9835442
REFERENCES
PMC9835442
Objective
cranial suture, craniosynostosis
CRANIOSYNOSTOSIS
Analgesia is very important for children with craniosynostosis who are undergoing cranial suture reconstruction. This study investigated the effectiveness and safety of an analgesic technique based on scalp nerve block combined with general anesthesia versus general anesthesia alone.
PMC10391876
Methods
cranial suture, scalp nerve block, pain
This was a single-center, prospective, randomized, controlled study. A total of 60 children aged 6-24 months who underwent cranial suture reconstruction were randomly divided into two groups: Group A (general anesthesia combined with scalp nerve block) and Group N (general anesthesia). The hemodynamics were recorded pr...
PMC10391876
Results
The mean arterial pressure and heart rate at 5 min after incision and 1 h after surgery in Group N were higher than those in Group A; the blood glucose and FLACC score in Group N were higher than those in Group A; and the number of postoperative analgesic pump presses were also significantly increased in Group N.
PMC10391876
Conclusion
cranial suture, postoperative pain, scalp nerve block
CRANIOSYNOSTOSIS
Preoperative scalp nerve block can reduce hemodynamic fluctuation and postoperative pain in children undergoing cranial suture reconstruction for craniosynostosis. Thus, it can be safely and effectively applied in the anesthesia of these children.
PMC10391876
Keywords
PMC10391876
Background
cranial suture, Craniosynostosis
DISEASE, CRANIOSYNOSTOSIS
Craniosynostosis is a relatively uncommon disease in pediatric neurosurgery that affects skull and brain development due to premature closure of the cranial suture [
PMC10391876
Methods
PMC10391876
Patients
ST-T depression, scalp nerve block, cranial suture, infection, left atrial enlargement, hypersensitivity
CONGENITAL DISORDERS, INFECTION, LEFT VENTRICULAR HYPERTROPHY, BUNDLE BRANCH BLOCK, CRANIOSYNOSTOSIS, HYPERSENSITIVITY, NEUROLOGICAL DISORDERS
The study was performed between Oct 1, 2021, and Oct 1, 2022. Written informed consent was obtained from the parents or relatives of patients. A total of 60 children (ASA I or II, aged 6 months to 24 months) who were scheduled for elective cranial suture reconstruction in the Department of Neurosurgery in Shanghai Chil...
PMC10391876
Anesthesia, surgery
breast milk
After preoperative fasting (6 h for solid food and then 4 h for breast milk), anesthesia and monitoring were standardized for all children. ECG, pulse oximetry and end-tidal CO
PMC10391876
Scalp nerve block
scalp nerve block, nerve block
In Group A, an ultrasound-guided bilateral scalp nerve block was performed with 0.3% ropivacaine before incision. The total dose of local anesthetic was 3.6 mg/kg in each patient. The procedures for nerve block were as follows:
PMC10391876
Supratrochlear nerve block
CORTEX
The nerve block was guided with an S-NERVE ultrasound machine (Sono Site, USA), an ultrahigh frequency line array probe was placed parallel to the brow arch, the probe position was adjusted, and the supraorbital notch was found on the ultrasound image (an interruption of the bony surface echo). In-plane technology was ...
PMC10391876
Supraorbital nerve block
CORTEX, LOCAL ANESTHETICS
When the supratrochlear nerve block was completed, the puncture needle continued parallel to the supraorbital notch. Then, 0.1 ml/kg local anesthetic was injected. Local anesthetic could be seen spread along the bone cortex of the brow arch and wrapped around the supraorbital notch (Fig.
PMC10391876
Auriculotemporal nerve block
Auriculotemporal nerve block
The ultrasound probe was placed parallel to and above the zygomatic arch, and the superficial temporal artery was found 1 cm above the root of the zygomatic arch in front of the tragus. An ultrasound-guided out-of-plane technique was employed, and 0.1 ml/kg local anesthetic was injected into the deep surface of the sup...
PMC10391876
Lesser occipital nerve block
occipital nerve block
Due to the limitation of resolution of the ultrasound probe, the superficial cervical plexus was blocked to block the lesser occipital nerve. The child lay in a supine position with the head tilted to the opposite side. The superficial cervical plexus was positioned ipsilateral to the superficial cervical plexus and th...
PMC10391876
Greater occipital nerve block
The child was placed in a lateral position, and the ultrasound probe was placed parallel to the superior collar line. The greater occipital artery was found lateral to the external occipital ridge, and 0.2 ml/kg local anesthetic was injected into the medial artery with the in-plane technique (Fig. Greater occipital ner...
PMC10391876
Postoperative pain relief
consolability, Pain, pain
After the operation, extubation was performed, and then the patients were transferred to the surgical intensive care unit (SICU). Patients in both groups received nurse-controlled analgesia (NCA) via an intravenous analgesia pump. The drug used for analgesia was 1 µg/kg sufentanil in saline (100 ml). The background dos...
PMC10391876
Outcome measurements
venous blood glucose
SECONDARY
The primary outcome objective of the study was the MAP, and the secondary objectives were the HR, FLACC scores, and venous blood glucose. The MAP and HR were recorded in 2 groups preoperatively (T
PMC10391876
Statistical analysis
Statistical analysis was performed with SPSS version 20.0 (SPSS, Inc., Chicago, Illinois, USA), and a value of Sample size calculation was performed based on the assumption that a difference of 30% in MAP was clinically relevant. With an α of 0.05 and power of 80%, 26 patients in each group were needed. Therefore, we c...
PMC10391876
Results
PMC10391876
Patient demographics and perioperative characteristics
Sixty children were included in this study. The results showed that there were no significant differences between the two groups in terms of sex, age, weight, height, duration of surgery and anesthesia, blood transfusion and loss (Table General characteristics of children in the 2 groups (x¯±s)
PMC10391876
Blood glucose, postoperative pain scores and analgesic consumption
pain
The blood glucose in Group N was significantly higher than that in Group A; pain scores at TPostoperative blood glucose level and FLACC score in the 2 groups (x¯±s)There was no significant difference in intraoperative sufentanil consumption between the 2 groups (P>0.05). The number of analgesic pump presses in Group N ...
PMC10391876
Pain control-related adverse events during the study period
toxicity, hematoma, pain
HEMATOMA, COMPLICATIONS, PUNCTURE SITE INFECTION
The hemodynamics, oxygen saturation and respiratory rate were stable in both groups in the postanesthetic care unit (PACU). There were no complications, such as puncture site infection, local anesthetic toxicity, or hematoma, in any of the patients, and no remedial analgesia was administered for severe pain.
PMC10391876
Discussion
toxicity, muscle breaks, pain, cranial suture, nerve block
PERIOSTEUM
In cranial suture reconstruction procedures, skin incision and peeling of the periosteum are the most painful processes and may increase the patient’s blood pressure and HR [Craniotomy-related pain is mainly caused by skin incisions and muscle breaks rather than the operation on the brain parenchyma. The scalp is mainl...
PMC10391876
Authors’ contributions
Tianxiao Zou designed the experiment, performed the experiments, analyzed the data and drafted the manuscript. Shenghua Yu designed and performed the experiments. Guili Ding and Rong Wei designed the experiment and revised the manuscript. All the authors read and approved the final manuscript.
PMC10391876
Funding
No funding was received for this study.
PMC10391876
Availability of data and materials
The datasets are not publicly available but are available from the corresponding author upon reasonable request.
PMC10391876
Declarations
PMC10391876
Ethics approval and consent to participate
This study was approved by the Institution Review Board (Ethics Commission of Children’s Hospital of Shanghai, Ref. No. 2021R029-F02; registered at the China Clinical Trial Registry Center, registration number ChiCTR2200066131), in accordance with the ethical guidelines of the Declaration of Helsinki. Written informed ...
PMC10391876
Consent for publication
Not applicable.
PMC10391876
Competing interests
The authors declare no competing interests.
PMC10391876
References
PMC10391876
1. Introduction
Pregnancy nutrition is important for maternal and child health and may affect the development of the infant gut microbiome. Our objective was to assess the feasibility of implementing a food-based intervention designed to increase fiber intake among pregnant women in a rural setting. Participants were enrolled (Diet in...
PMC9958944
2. Materials and Methods
PMC9958944
2.1. Recruitment
Pregnant participants were recruited from a single prenatal care clinic serving a rural population in the northwest region of Michigan’s Lower Peninsula. Inclusion criteria were maternal age of at least 18 years, pregnant with a gestational age of approximately 22 weeks at enrollment, and no self-reported contraindicat...
PMC9958944
2.2. Intervention and Usual Care
A two-arm randomized controlled trial design was implemented with women enrolled in mid-pregnancy (
PMC9958944
2.3. Diet Assessment
Cancer
CANCER
Maternal diet was assessed before (i.e., 24-weeks gestation) and 4 weeks after the initiation of the intervention (i.e., 36-weeks gestation), and at 6 weeks postpartum. Participants were asked to complete self-administered 24-hour dietary recalls utilizing the 2016 version of the Automated Self-Administered 24-hr (ASA-...
PMC9958944
2.4. Survey and Biospecimen Collection, Storage, and Analyses
BLOOD
Data collection included surveys (including sociodemographic and behavioral information as well as the ASA-24 described above), maternal blood, urine, and stool collection at three time points (24- and 36-weeks gestation [pre- and 4-weeks post-intervention initiation, respectively]; and at 6 weeks postpartum), and infa...
PMC9958944
3. Results
PMC9958944
3.1. Participants
Our sample was considered entirely rural, and maternal characteristics reflected the local population (
PMC9958944
3.2. Feasibility and Acceptability of Implementing Study Procedures
Data collection adherence was high with few missing data points. Overall satisfaction was high, with 85% reporting satisfied or very satisfied, and important qualitative insights were gained from participants. Participants who completed the final study visit (
PMC9958944
3.3. Dietary Intake Data
Per protocol, participants were instructed to self-complete two 24-hour dietary recalls using the ASA-24 online system at three different time points (24- and 36-weeks gestation, and 6 weeks postpartum).
PMC9958944
3.4. Urinary Trace Elements
Descriptive measures of trace element concentrations assessed from urine samples collected at 36-weeks gestation are reported in
PMC9958944
3.5. Results Published To-Date
In this publication, we focus on the feasibility and acceptability of data, but there are both ongoing and previously published findings from the biospecimen analyses resulting from this pilot study. Data published elsewhere reported the positive association between dietary and plasma carotenoids with alpha diversity i...
PMC9958944
4. Discussion
CHRONIC DISEASE
The aim of this study was to test procedures, including methods of randomization and outcome measurement, to assess the feasibility and acceptability of implementing a pragmatic, scalable, and replicable food-based intervention that can be used for answering important research questions, especially pertaining to infant...
PMC9958944
5. Conclusions
This pilot trial produced valuable information. The intervention was tested with 27 pregnant women residing in rural Michigan. Retention was high at 93%, with 85% of participants reporting high satisfaction. Among the parameters compared across or within study arms, no significant differences were observed in dietary i...
PMC9958944
Author Contributions
J.M.K. and S.S.C. conceptualized the study, acquired funding, provided oversight for all study activities, and reviewed and edited the manuscript. J.C.G. assisted in conceptualizing the study and conducted the randomization schema. Y.K. assisted in the original draft preparation. J.M.G. provided oversight for study imp...
PMC9958944
Institutional Review Board Statement
MAY
This study was conducted in accordance with the Declaration of Helsinki, and approved on 19 May 2017 by the Institutional Review Board (or Ethics Committee) of Michigan State University and Munson Medical Center (IRB #16-1515 and 1026493).
PMC9958944
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC9958944
Data Availability Statement
Data are available upon request from the corresponding author.
PMC9958944
Conflicts of Interest
The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.
PMC9958944
References
Study flyer with timeline and incentive structure.Maternal characteristics at study enrollment.Visit participation rates.Patient satisfaction (free-text responses).Dietary intake pre- and post-intervention by study arm (Trace elements (μg/L) from urine specimens collected at 36-weeks gestation (
PMC9958944
Background
drink-flavored bowel preparation, drink bowel preparation, colon cancer
COLON CANCER
Acceptability and tolerance of bowel preparation is critical to overcome patient hesitancy in undergoing colon cancer screening and surveillance colonoscopy. To improve patient experience, a new sports drink-flavored bowel preparation containing polyethylene glycol (PEG) and sulfate salts (FPSS) was developed to provid...
PMC10712137
Methods
This FPSS preparation, approved by the FDA in June 2023, was evaluated in a non-randomized Phase 2 study in which 40 patients requiring colonoscopy were prepared with FPSS and 20 with PEG-SD.
PMC10712137
Results
Overall cleansing success was high with FPSS based on unblinded local endoscopist assessment (93%) and blinded central reading (97%), exceeding PEG-SD which achieved success rates of 84% (local read), 74% and 68% (blinded central reads). Similar differences favoring FPSS were seen for excellent preparations and cleansi...
PMC10712137
Conclusion
The new sports drink-like flavored preparation compares favorably to PEG-SD for bowel cleansing efficacy while achieving similar patient satisfaction. The study was registered at
PMC10712137
Keywords
PMC10712137
Introduction
Despite improvements in prescription bowel preparation technology, a significant proportion of colonoscopy preparations offered to patients are not approved by the FDA, but rather are over-the-counter laxative combinations [Studies by Walker et al. [To provide healthcare practitioners and patients the positive attribut...
PMC10712137
Methods
colorectal cancer, the bowel preparation
ADVERSE EVENTS, COLORECTAL CANCER, COLON
This was an open-label, active-controlled, sequential-cohort study in adult patients undergoing colonoscopy for colorectal cancer screening and surveillance or for diagnostic purposes. This study was conducted at 4 U.S. endoscopy centers and approved by Aspire, Institutional Review Board and registered on A screening v...
PMC10712137
Author contributions
J.A. D., M.vB.C., and J.D.M. conceived and designed the project. G.W. and P.W. collected the data. M.vB.C., and J.D.M. analyzed and interpreted the data. J.A.D., M.vB.C., and J.D.M. drafted the manuscript. All authors read and approved the final manuscript.
PMC10712137
Funding
This work was supported by Braintree Laboratories, Inc.
PMC10712137
Data Availability
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
PMC10712137
Declarations
PMC10712137
Ethics approval and consent to participate
All methods were carried out in accordance with relevant guidelines and regulations. The study protocol was approved by WCG IRB (Payallup, WA) and informed consent was obtained from all subjects.
PMC10712137
Consent for publication
Not Applicable.
PMC10712137
Competing interests
Di
Dr. Di Palma is a consultant medical director for Braintree Laboratories. Dr. Cleveland is a scientific consultant. Mr. McGowan is a Braintree employee. The other authors have no competing interests.
PMC10712137
References
PMC10712137
Key Points
PMC10394570
Question
CASTRATION-SENSITIVE PROSTATE CANCER
Do Black patients with metastatic castration-sensitive prostate cancer have worse outcomes than White patients when treated with systemic androgen deprivation therapy combined with a first- or a second-generation androgen receptor pathway inhibitor?
PMC10394570
Findings
CASTRATION-SENSITIVE PROSTATE CANCER, SECONDARY
In this secondary analysis of a randomized phase 3 clinical trial with 1313 patients with metastatic castration-sensitive prostate cancer, there was no statistically significant difference in overall survival and progression-free survival between Black and White patients.
PMC10394570
Meaning
CASTRATION-SENSITIVE PROSTATE CANCER, SECONDARY
These results suggest that providing fair and equal access to health care may reduce the disparities in treatment outcomes between Black and White patients with advanced prostate cancer.This secondary analysis of a randomized clinical trial evaluates the association of race with survival among patients with metastatic ...
PMC10394570
Importance
aggressive disease
PROSTATE CANCER, PROSTATE
Black patients present with more aggressive disease and experience higher mortality than White patients with prostate cancer. Race and social determinants of health influence prostate cancer-specific mortality and overall survival (OS); however, in a previous trial, Black patients did not have inferior outcomes compare...
PMC10394570
Objective
CASTRATION-SENSITIVE PROSTATE CANCER
To compare differences in survival outcomes of patients with metastatic castration-sensitive prostate cancer (mCSPC) by race in a phase 3 trial with a large proportion of Black patients.
PMC10394570
Design, Setting, and Participants
SECONDARY
This secondary analysis of patient-level data of a prospective phase 3 randomized clinical trial included patients with newly diagnosed mCSPC enrolled between March 1, 2013, and July 15, 2017. Analysis was conducted between December 2022 and February 2023.
PMC10394570
Interventions
Patients receiving androgen deprivation therapy were randomized (1:1) to receive either orteronel 300 mg orally twice daily (experimental group) or bicalutamide 50 mg orally daily (control group).
PMC10394570
Main Outcomes and Measures
SECONDARY
OS, with progression-free survival (PFS) as a secondary end point.
PMC10394570
Results
Among 1313 participants, 135 (10%) identified as Black and 1077 (82%) as White, with an equal racial distribution between groups. Black patients were younger (median [IQR] age, 65.8 [60-70] vs 68.4 [62.5-74.1] years;
PMC10394570
Conclusions and Relevance
SECONDARY
In this secondary analysis of a randomized clinical trial studying androgen deprivation therapy with first- or second-generation androgen receptor pathway inhibitors, both Black and White patients demonstrated similar OS and PFS. Equitable access to care may reduce historical differences in outcomes between Black and W...
PMC10394570