Design and baseline characteristics of a low-income urban cohort of children with asthma: The Asthma Action at Erie Trial

ObjectiveTo describe the methodology of a randomized controlled trial comparing the efficacy of integrated asthma community health workers (CHW) and a certified asthma educator (AE-C) to improve asthma outcomes in low-income minority children in Chicago.MethodsChild/caregiver dyads were randomized to CHW home visits or education in the clinic from an AE-C. Intervention was delivered in the first year after enrollment. Data collection occured at baseline, 6-, 12-, 18, and 24-months. The co-primary outcomes included asthma control using the Asthma Control Test/childhood Asthma Control Test (ACT/cACT) and activity limitation over the past 14 days.ResultsA total of 223 participants ages 5–16 years were randomized. The majority of children were in the 5–11 year old range (78.9%). Most caregivers (96.9%) and 44% of children were female. Approximately 85% of caregivers and children reported Hispanic ethnicity and 62.3% reported a household income of ≤ $59,000. Over half (55.7%) had uncontrolled asthma as measured by ACT/cACT; 13.9% had a normal ACT/cACT score but were uncontrolled using the Asthma Control Questionnaire and 20.2% were controlled on both measures but had received oral steroids in the past year for asthma.ConclusionThe Asthma Action at Erie Trial successfully recruited a largely Hispanic cohort of children with uncontrolled or high-risk asthma to study the differential effects of clinic-based AE-C and home-based CHW interventions. Strengths of the trial include its comparative effectivness design that integrates interventionists and intervention delivery into a clinical setting. Categorizing asthma control in community settings for research purposes presents unique challenges.Clinical trial registrationUniversity of Illinois at Chicago Protocol Record R01HL123797, Asthma Action at Erie TrialClinicalTrials.gov Identifier: NCT02481986 “ClinicalTrials.gov Registration” register@clinicaltrials.gov     

Defining Optimal Care for Functional Gut Disorders - Multi-Disciplinary Versus Standard Care: A Randomized Controlled Trial Protocol

BackgroundFunctional gastrointestinal disorders (FGIDs) are the commonest reason for gastroenterological consultation, with patients usually seen by a specialist working in isolation. There is a wealth of evidence testifying to the benefit provided by dieticians, behavioral therapists, hypnotherapists and psychotherapists in treating these conditions, yet they rarely form a part of the therapeutic team, and these treatment modalities are rarely offered as part of the therapeutic management. There has been little examination of different models of care for FGIDs. We hypothesize that multi-disciplinary integrated care is superior to standard specialist-based care in the treatment of functional gut disorders.MethodsThe “MANTRA” (Multidisciplinary Treatment for Functional Gut Disorders) study compares comprehensive multi-disciplinary outpatient care with standard hospital outpatient care. Consecutive new referrals to the gastroenterology and colorectal outpatient clinics of a single secondary and tertiary care hospital of patients with an FGID, defined by the Rome IV criteria, will be included. Patients will be prospectively randomized 2:1 to multi-disciplinary (gastroenterologist, gut-hypnotherapist, psychiatrist, behavioral therapist (‘biofeedback’) and dietician) or standard care (gastroenterologist or colorectal surgeon). Patients are assessed up to 12 months after completing treatment. The primary outcome is an improvement on a global assessment scale at the end of treatment. Symptoms, quality of life, psychological well-being, and healthcare costs are secondary outcome measures.DiscussionThere have been few studies examining how best to deliver care for functional gut disorders. The MANTRA study will define the clinical and cost benefits of two different models of care for these highly prevalent disorders.TRIAL REGISTRATION Number: Clinicaltrials.gov NCT03078634Registered on Clinicaltrials.gov, completed recruitment, registered on March 13th 2017.Ethics and Dissemination:Ethical approval has been received by the St Vincent's Hospital Melbourne human research ethics committee (HREC-A 138/16). The results will be disseminated in peer-reviewed journals and presented at international conferences.Protocol version 1.2     

Design and sample characteristics of COordinated Oral health Promotion (CO-OP) Chicago: A cluster-randomized controlled trial

COordinated Oral health Promotion (CO-OP) Chicago is a two-arm cluster-randomized trial with a wait-list control. The primary aim is to evaluate the efficacy of an oral health community health worker (CHW) intervention to improve oral health behaviors in low-income, urban children under the age of three years. Exploratory aims will determine cost-effectiveness, and if any CHW intervention impact on child tooth brushing behaviors varies when CHWs are based out of a medical clinic compared to a community setting. This paper describes progress toward achieving these aims. Participating families were recruited from community social service centers and pediatric primary care medical clinics in Cook County, Illinois. Sites were cluster-randomized to CHW intervention or usual services (a wait-list control). The intervention is oral health support from CHWs delivered in four visits to individual families over one year. The trial sample consists of 420 child/caregiver dyads enrolled at the 20 participating sites over 11 months. Participant demographics varied across the sites, but primary outcomes values at baseline did not. Data on brushing frequency, plaque, and other oral health behaviors are collected at three timepoints: baseline, 6-, and 12-months. The primary analysis will assess differences in caregiver-reported child brushing frequency and observed plaque score between the two arms at 12-months. The trial is currently in the active intervention phase. The trial's cluster-randomized controlled design takes a real-world approach by integrating into existing health and social service agencies and collecting data in participant homes. Results will address an important child health disparity. ClinicalTrials.gov identifier: NCT03397589.Clinical trial registrationUniversity of Illinois at Chicago Protocol Record 2017–1090. National Institutes of Dental & Craniofacial Research of the National Institutes of Health (NIDCR) Protocol Number: 17–074-E. NCT03397589     

Hellenic Postprandial Lipemia Study (HPLS): Rationale and design of a prospective,open-label trial to determinate the prevalence of abnormal postprandial lipemia as well as its interaction with statins in patients at high- and very high-risk for cardiovascular disease

Fasting and postprandial hypertriglyceridemia have been related to cardiovascular (CV) disease. We describe the design and methods of the Hellenic Postprandial Lipemia Study (HPLS, NCT02163044), a prospective, open-label, randomized, multicentre trial. The study will recruit 900 participants from 8 centers, and aims to determinate the prevalence of abnormal postprandial lipemia in patients at high- and very high-risk for CV disease, the efficacy of statin treatment and other medications on postprandial lipemia, and the interaction between postprandial lipemia and CV risk during a treatment period of 3 years. Participants will be screened in an outpatient lipid clinic setting.MethodsHigh- and very high-risk individuals with fasting triglycerides (TGs) <220 mg/dL (2.5 mmol/L) will be included. At baseline visit demographic and clinical characteristics will be recorded. At the first follow-up visit (within 2–4 weeks from baseline), plasma TG concentrations will be measured, following an overnight 12 h fasting period, before and 4 h after ingestion of a commercially available oral fat tolerance test (OFTT) meal. Then a statin will be prescribed. At the second follow-up visit (within 3–5 month from baseline), plasma TG concentrations will be measured again following an overnight 12 h fasting period, before and 4 h after ingestion of OFTT and then patients will be followed annually for 3 years.ConclusionHPLS is the largest trial assessing the effects of statin therapy on postprandial lipemia. Its results will provide useful insight on the prevalence of postprandial lipemia, the efficacy of statins regarding postprandial lipemia and the clinical significance of this effect.Clinical trial registration informationThe HPLS trial is registered with clinicaltrials.gov (NCT Identifier: NCT02163044).     

Augmenting usual care SSRIs with cognitive behavioral therapy for insomnia to improve depression outcomes in youth: Design of a randomized controlled efficacy-effectiveness trial

ImportanceExtant treatments for youth depression are only modestly effective. Alternative approaches are needed to improve health outcomes. A novel approach to improve depression outcomes is suggested by epidemiological studies finding that insomnia often predates and may contribute to depression risk. We test whether treating insomnia among youth starting a new course of SSRI antidepressants improves depression outcomes. This paper describes our study design.Design2-arm randomized controlled efficacy-effectiveness trial.SettingA large non-profit health maintenance organization.Participants165 adolescents aged 12–19 with research-confirmed depression and insomnia diagnoses, starting a new episode of selective serotonin reuptake inhibitor (SSRI) antidepressant treatment prescribed by their usual care provider.InterventionsTwo sleep interventions, each 6–7 sessions, both overlaying “treatment as usual” (TAU) SSRIs: a sleep hygiene (SH) attention control condition, and cognitive-behavioral therapy for insomnia (CBTI).Conclusions and relevanceIf CBT-I improved sleep is shown to improve depression-related outcomes, this may provide an additional, easily tolerated intervention for an important public health target.Trial Registration: clinicaltrials.gov, NCT02290496, https://clinicaltrials.gov/ct2/show/NCT02290496.     

CAN: Context-assisted full Attention Network for brain tissue segmentation

Brain tissue segmentation is of great value in diagnosing brain disorders. Three-dimensional (3D) and two-dimensional (2D) segmentation methods for brain Magnetic Resonance Imaging (MRI) suffer from high time complexity and low segmentation accuracy, respectively. To address these two issues, we propose a Context-assisted full Attention Network (CAN) for brain MRI segmentation by integrating 2D and 3D data of MRI. Different from the fully symmetric structure U-Net, the CAN takes the current 2D slice, its 3D contextual skull slices and 3D contextual brain slices as the input, which are further encoded by the DenseNet and decoded by our constructed full attention network. We have validated the effectiveness of the CAN on our collected dataset PWML and two public datasets dHCP2017 and MALC2012. Our code is available at https://github.com/nwuAI/CAN.     

A virtual learning collaborative to implement health promotion in routine mental health settings: Protocol for a cluster randomized trial

BackgroundDespite widespread use of learning collaboratives in health care, few randomized trials have evaluated their effectiveness. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to standard individual technical assistance.MethodsForty-eight mental health provider organizations from across the United States will be recruited to participate in the trial. The evidence-based practice to be implemented is the InSHAPE health promotion intervention for persons with SMI. Sites will be stratified by size and randomized to receive an 18-month intensive group-based VLC with monthly learning sessions or individual technical assistance with four scheduled conference calls over 18 months. Sites will be enrolled in three blocks of 16 sites each. The primary outcomes are InSHAPE program participation and fidelity, and participant weight loss; secondary outcomes are program operation, program uptake, participant health behaviors of physical activity and nutrition, organizational change, and program sustainment. Implementation outcomes are measured at 3, 6, 12, 18, and 24 months after the program start-up. Participant-level outcomes are measured at fixed intervals every 3 months after each participant enrolls in the study.DiscussionThis study will determine whether VLCs are an effective implementation strategy among resource-limited providers when the new practice necessitates a shift in mission, scope of practice, type of services delivered, and new financing.Trial registrationClinicalTrials.gov identifier: NCT03891368Registered 25 March 2019, retrospectively registered.https://clinicaltrials.gov/ct2/show/NCT03891368?term=NCT03891368&rank=1     

Changes in frailty among ICU survivors and associated factors: Results of a one-year prospective cohort study using the Dutch Clinical Frailty Scale

PurposeFrailty is an important predictor for the prognosis of intensive care unit (ICU) patients. This study examined changes in frailty in the year after ICU admission, and its associated factors.Materials and methodsProspective cohort study including adult ICU patients admitted between July 2016–December 2017. Frailty was measured using the Clinical Frailty Scale (CFS), before ICU admission, at hospital discharge, and three and 12 months after ICU admission. Multivariable linear regression was used to explore factors associated with frailty changes.ResultsFrailty levels changed among 1300 ICU survivors, with higher levels at hospital discharge and lower levels in the following months. After one year were 42% of the unplanned, and 27% of the planned patients more frail. For both groups were older age, longer hospital length of stay, and discharge location associated with being more frail. Male sex, higher education level and mechanical ventilation were associated with being less frail in the planned patients.ConclusionOne year after ICU admission, 42% and 27% of the unplanned and planned ICU patients, respectively, were more frail. Insight in the associated factors will help to identify patients at risk, and may help in informing patients and their family members.RegistrationClinicalTrials.gov database (NCT03246334).     

Integrating machine-generated mortality estimates and behavioral nudges to promote serious illness conversations for cancer patients: Design and methods for a stepped-wedge cluster randomized controlled trial

IntroductionPatients with cancer often receive care that is not aligned with their personal values and goals. Serious illness conversations (SICs) between clinicians and patients can help increase a patient's understanding of their prognosis, goals and values.Methods and analysisIn this study, we describe the design of a stepped-wedge cluster randomized trial to evaluate the impact of an intervention that employs machine learning-based prognostic algorithms and behavioral nudges to prompt oncologists to have SICs with patients at high risk of short-term mortality. Data are collected on documented SICs, documented advance care planning discussions, and end-of-life care utilization (emergency room and inpatient admissions, chemotherapy and hospice utilization) for patients of all enrolled clinicians.ConclusionThis trial represents a novel application of machine-generated mortality predictions combined with behavioral nudges in the routine care of outpatients with cancer. Findings from the trial may inform strategies to encourage early serious illness conversations and the application of mortality risk predictions in clinical settings.Trial Registration: Clinicaltrials.gov Identifier: NCT03984773     

Prediction using a randomized evaluation of data collection integrated through connected technologies (PREDICT): Design and rationale of a randomized trial of patients discharged from the hospital to home

BackgroundHospital readmission prediction models often perform poorly. A critical limitation is that they use data collected up until the time of discharge but do not leverage information on patient behaviors at home after discharge.MethodsPREDICT is a two-arm, randomized trial comparing ways to use remotely-monitored patient activity levels after hospital discharge to improve hospital readmission prediction models. Patients are randomly assigned to use a wearable device or smartphone application to track physical activity data. The study collects also validated assessments on patient characteristics as well as disparate data on credit scores and medication adherence. Patients are followed for 6 months. We evaluate whether these data sources can improve prediction compared to standard modelling approaches.ConclusionThe PREDICT Trial tests a novel method of remotely-monitoring patient behaviors after hospital discharge. Findings from the trial could inform new ways to improve the identification of patients at high-risk for hospital readmission.Trial RegistrationClinicaltrials.gov Identifier: NCT02983812     

Noninvasive ventilation support during fiberoptic bronchoscopy-guided nasotracheal intubation effectively prevents severe hypoxemia

PurposeThis study investigated the feasibility and efficacy of continuous noninvasive ventilation (NIV) support with 100% oxygen using a specially designed face mask, for reducing desaturation during fiberoptic bronchoscopy (FOB)-guided intubation in critically ill patients with respiratory failure.Materials and methodsThis was a single-center prospective randomized study. All patients undergoing FOB-guided nasal tracheal intubation were randomized to bag-valve-mask ventilation or NIV for preoxygenation followed by intubation. The NIV group were intubated through a sealed hole in a specially designed face mask during continuous NIV support with 100% oxygen. Control patients were intubated with removal of the mask and no ventilatory support.ResultsWe enrolled 106 patients, including 53 in each group. Pulse oxygen saturation (SpO₂) after preoxygenation (99% (96%–100%) vs. 96% (90%–99%), p = .001) and minimum SpO₂ during intubation (95% (87%–100%) vs. 83% (74%–91%), p < .01) were both significantly higher in the NIV compared with the control group. Severe hypoxemic events (SpO₂ < 80%) occurred less frequently in the NIV group than in controls (7.4% vs. 37.7%, respectively; p < .01).ConclusionsContinuous NIV support during FOB-guided nasal intubation can prevent severe desaturation during intubation in critically ill patients with respiratory failure.Trial registration: ClinicalTrials.gov, NCT02462668. Registered on 25 May 2015, https://www.clinicaltrials.gov/ct2/results?term=NCT02462668.     

Interim monitoring in a treatment strategy trial with a composite primary endpoint

When a clinical trial has a composite endpoint and a comparison of treatment strategies with multiple intervention components, interim data reviews by a data safety and monitoring board (DSMB) can be challenging as the data evolve on multiple fronts. We illustrate with a study in the treatment of Kaposi sarcoma (KS), an HIV-associated cancer with a multi-faceted disease presentation. The study, ACTG-A5264/AMC-067, was a 1:1 randomized trial to compare two strategies: immediate initiation of etoposide with antiretroviral therapy (ART), or ART with delayed etoposide upon disease progression. The outcome was a composite endpoint that included the following events, ordered from worst to best in the following three categories: (1) KS progression at 48 weeks, death, initiation of alternate KS treatment, loss to study follow-up; (2) stable KS; and (3) partial or complete KS response at 48 weeks. We present the interim results on the composite endpoint and the individual components, where components favored different study arms at an interim review. To facilitate interim data monitoring for complex trials, we recommend clear communications between the study team and the DSMB prior to the initiation of the trial on the need for a composite endpoint, the intentions behind the defined strategies, and relative importance of individual components of the composite endpoint. We also recommend flexibility in the timing of data reviews by the DSMB to interpret emerging data in multiple dimensions.Clinicaltrials.gov NCT01352117     

Is ChatGPT a valid author?

This letter to the editors takes a deeper look at the validity and ethics of authorship of a recently published article in Nurse Education in Practice in which authorship was shared with a chatbox software program, ChatGPT (https://doi.org/10.1016/j.nepr.2022.103537). In particular, a closer assessment is made of the authorship of that article from the established principles of authorship as delineated by the ICMJE.     

The effects of an enteral nutrition feeding protocol on critically ill patients: A prospective multi-center,before-after study

PurposeThe aim of this study was to explore the effects of an enteral nutrition (EN) feeding protocol in critically ill patients.MethodsThis was a prospective multi-center before-after study. We compared energy related and prognostic indicators between the control group (pre-implementation stage) and intervention group (post-implementation stage). The primary endpoint was the percentage of patients receiving EN within 7 days after ICU admission.Results209 patients in the control group and 230 patients in the intervention group were enrolled. The implementation of the EN protocol increased the percentage of target energy reached from day 3 to day 7, and the difference between two groups reached statistical significance in day 6 (P = .01) and day 7 (P = .002). But it had no effects on proportion of patient receiving EN (P = .65) and start time of EN (P = .90). The protocol application might be associated with better hospital survival (89.1% vs 82.8%, P = .055) and reduce the incidence of EN related adverse (P = .004). There was no difference in ICU length of stay, duration of mechanical ventilation and ICU cost.ConclusionThe implementation of the enteral feeding protocol is associated with improved energy intake and a decreased incidence of enteral nutrition related adverse events for critically ill patients, but it had no statistically beneficial effects on reducing the hospital mortality rate.Trial registrationClinicalTrials.gov, NCT02976155. Registered November 29, 2016- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02976155.     

Histogram of Oriented Gradients meet deep learning: A novel multi-task deep network for 2D surgical image semantic segmentation

We present our novel deep multi-task learning method for medical image segmentation. Existing multi-task methods demand ground truth annotations for both the primary and auxiliary tasks. Contrary to it, we propose to generate the pseudo-labels of an auxiliary task in an unsupervised manner. To generate the pseudo-labels, we leverage Histogram of Oriented Gradients (HOGs), one of the most widely used and powerful hand-crafted features for detection. Together with the ground truth semantic segmentation masks for the primary task and pseudo-labels for the auxiliary task, we learn the parameters of the deep network to minimize the loss of both the primary task and the auxiliary task jointly. We employed our method on two powerful and widely used semantic segmentation networks: UNet and U2Net to train in a multi-task setup. To validate our hypothesis, we performed experiments on two different medical image segmentation data sets. From the extensive quantitative and qualitative results, we observe that our method consistently improves the performance compared to the counter-part method. Moreover, our method is the winner of FetReg Endovis Sub-challenge on Semantic Segmentation organised in conjunction with MICCAI 2021. Code and implementation details are available at:https://github.com/thetna/medical_image_segmentation.     

Enhancing prolonged exposure therapy for PTSD among veterans with oxytocin: Design of a multisite randomized controlled trial

Posttraumatic stress disorder (PTSD) is the most highly prevalent mental health disorder among U.S. military Veterans. Prolonged Exposure (PE) therapy is one of the most widely used evidence-based treatments for PTSD, but there is substantial room for improvement in outcomes and retention rates. Accumulating data suggest that oxytocin offers a promising pharmacological approach towards achieving this goal. Therefore, the primary objective of this two-site Phase II study is to examine the ability of oxytocin (vs. placebo) administration combined with PE therapy to (1) reduce PTSD symptom severity, (2) accelerate the rate of PTSD symptom improvement, and (3) improve PE adherence and retention rates. To accomplish these objectives, we will employ a randomized, double-blind, placebo-controlled trial and use standardized, repeated dependent measures of change at five time points (baseline, mid-treatment, end of treatment, and 3 and 6 month follow-up). Intranasal oxytocin (40 IU) will be administered directly prior to each PE therapy session. Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the physiological mechanisms underlying PTSD and positive treatment response. ClinicalTrials.gov Identifier: NCT04228289     

CaDIS: Cataract dataset for surgical RGB-image segmentation

Video feedback provides a wealth of information about surgical procedures and is the main sensory cue for surgeons. Scene understanding is crucial to computer assisted interventions (CAI) and to post-operative analysis of the surgical procedure. A fundamental building block of such capabilities is the identification and localization of surgical instruments and anatomical structures through semantic segmentation. Deep learning has advanced semantic segmentation techniques in the recent years but is inherently reliant on the availability of labelled datasets for model training. This paper introduces a dataset for semantic segmentation of cataract surgery videos complementing the publicly available CATARACTS challenge dataset. In addition, we benchmark the performance of several state-of-the-art deep learning models for semantic segmentation on the presented dataset. The dataset is publicly available at https://cataracts-semantic-segmentation2020.grand-challenge.org/.     

Effects of milrinone on renal perfusion,filtration and oxygenation in patients with acute heart failure and low cardiac output early after cardiac surgery

PurposeEarly postoperative heart failure is common after cardiac surgery, and inotrope treatment may impact renal perfusion and oxygenation. We aimed to study the renal effects of the inodilator milrinone when used for the treatment of heart failure after weaning from cardiopulmonary bypass (CPB).Material and methodsIn 26 patients undergoing cardiac surgery with CPB, we used renal vein catheterization to prospectively measure renal blood flow (RBF), glomerular filtration rate (GFR), and renal oxygenation. Patients who developed acute heart failure and low cardiac output (cardiac index <2.1 L/min/m²) at 30 min after weaning from CPB (n = 7) were given milrinone, and the remaining patients (n = 19) served as controls. Additional measurements were made at 60 min after CPB.ResultsIn patients with acute postoperative heart failure, before receiving milrinone, renal blood flow was lower (−33%, p < .05) while renal oxygen extraction was higher (41%, p < .05) compared to the control group. Milrinone increased cardiac index (21%, p < .001), RBF (36%, p < .01) and renal oxygen delivery (35%, p < .01), with no significant change in GFR and oxygen consumption compared to the control group.ConclusionsIn patients with acute heart failure after weaning from CPB, the milrinone-induced increase in cardiac output was accompanied by improved renal oxygenation.Trial registrationClinicalTrials.gov; identifier NCT02405195, date of registration; March 27, 2015, and NCT02549066, date of registration; 9 September 2015.