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Nevin Manimala Statistics

Remote Monitoring Compared With In-Office Surveillance of Blood Pressure in Patients With Pregnancy-Related Hypertension: A Randomized Controlled Trial

Obstet Gynecol. 2023 Oct 1;142(4):855-861. doi: 10.1097/AOG.0000000000005327. Epub 2023 Sep 7.

ABSTRACT

OBJECTIVE: To compare the rate of blood pressure ascertainment within 10 days of postpartum discharge among individuals with hypertensive disorders of pregnancy randomized either to in-office blood pressure assessment or at-home monitoring.

METHODS: This was a multisite randomized controlled trial of postpartum patients diagnosed with a hypertensive disorder of pregnancy before discharge between April 2021 and September 2021 and was performed at two academic training institutions. Patients were randomized to either an in-office blood pressure check or remote monitoring through a web-enabled smartphone platform. The primary outcome was the rate of any blood pressure ascertainment within 10 days of discharge. Secondary outcomes include rates of initiation of antihypertensive medication, readmission, and additional office or triage visits for hypertension. Assuming a 10-day postdischarge blood pressure ascertainment rate of 50% in the in-office arm, we estimated that 186 participants would provide 80% power to detect a 20% difference in the primary outcome between groups.

RESULTS: One hundred ninety-seven patients were randomized (96 remote, 101 in-office). Patients with remote monitoring had higher rates of postpartum blood pressure ascertainment compared with in-office surveillance (91.7% [n=88] vs 58.4% [n=59]; P<.001). There were 11 (11.5%) patients in the intervention arm whose only qualifying blood pressure was a postdischarge in-person ascertainment, yielding a true remote monitoring uptake rate of 80.2%. In those with remote blood pressure uptake (n=77), the median number of blood pressure checks was 15 (interquartile range 6-26) and the median duration of remote monitoring use was 14 days (interquartile range 9-16). There were no differences in rates of readmission for hypertension (5.0% [n=5] vs 4.2% [n=4], P=.792) or initiation of antihypertensive medications after discharge (9.4% [n=9] vs 6.9% [n=7], P=.530). Rates of unscheduled visits were increased in the remote monitoring arm, but this did not reach statistical significance (5.0% [n=5] vs 12.5% [n=12], P=.059). When stratifying the primary outcome by race and randomization group, Black patients had lower rates of blood pressure ascertainment than White patients when assigned to in-office surveillance (41.2% [n=14] vs 69.5% [n=41], P=.007), but there was no difference in the remote management group (92.9% [n=26] vs 92.9% [n=52], P>.99).

CONCLUSION: Remote monitoring can increase postpartum blood pressure ascertainment within 10 days of discharge for women with hypertensive disorders of pregnancy and has the potential to promote health equity.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04823949.

PMID:37734091 | DOI:10.1097/AOG.0000000000005327

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Nevin Manimala Statistics

TMM: A comprehensive CAD system for hepatic fibrosis 5-grade METAVIR staging based on liver MRI

Med Phys. 2023 Sep 21. doi: 10.1002/mp.16700. Online ahead of print.

ABSTRACT

BACKGROUND: Precise staging of hepatic fibrosis with MRI is necessary as it can assist precision medicine. Computer aided diagnosis (CAD) system with distinguishing radiomics features and radiologists domain knowledge is expected to obtain 5-grade meta-analysis of histological data in viral hepatitis (METAVIR) staging.

PURPOSE: This study aims to obtain the precise staging of hepatic fibrosis based on MRI as it predicts the risk of future liver-related morbidity and the need for treatment, monitoring and surveillance. Based on METAVIR score, fibrosis can be divided into five stages. Most previous researches focus on binary classification, such as cirrhosis versus non-cirrhosis, early versus advanced fibrosis, and substantial fibrosis or not. In this paper, a comprehensive CAD system TMM is proposed to precisely class hepatic fibrosis into five stages for precision medicine instead of the common binary classification.

METHODS: We propose a novel hepatic fibrosis staging CAD system TMM which includes three modules, Two-level Image Statistical Radiomics Feature (TISRF), Monotonic Error Correcting Output Codes (MECOC) and Monotone Multiclassification with Deep Forest (MMDF). TISRF extracts radiomics features for distinguishing different hepatic fibrosis stages. MECOC is proposed to encode monotonic multiclass by making full use of the progressive severity of hepatic fibrosis and increase the fault tolerance and error correction ability. MMDF combines multiple Deep Forest network to ensure the final five-class classification, which can achieve more precise classification than the common binary classification. The performance of the proposed hepatic fibrosis CAD system is tested on the hepatic data collected from our rabbits models of fibrosis.

RESULTS: A total of 140 regions of interest (ROI) are selected from MRI T1W of liver fibrosis models in 35 rabbits with F0(n = 16), F1(n = 28), F2(n = 29), F3(n = 44) and F4(n = 23). The performance is evaluated by five-fold cross-validation. TMM can achieve the highest total accuracy of 72.14% for five fibrosis stages compared with other popular classifications. To make a comprehensive comparison, a binary classification experiment have been carried out.

CONCLUSIONS: T1WI can obtain precise staging of hepatic fibrosis with the help of comprehensive CAD including radiomics features extraction inspired by radiologists, monotonic multiclass according to the severity of hepatic fibrosis, and deep learning classification.

PMID:37734071 | DOI:10.1002/mp.16700

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Nevin Manimala Statistics

Win Statistics in Pulmonary Arterial Hypertension Clinical Trials

Am J Respir Crit Care Med. 2023 Sep 21. doi: 10.1164/rccm.202305-0800LE. Online ahead of print.

NO ABSTRACT

PMID:37734029 | DOI:10.1164/rccm.202305-0800LE

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Nevin Manimala Statistics

National Trends in Cochlear Implantation Across the Department of the Defense: A Case for Inclusion as a General Otolaryngology Core Competency

Otol Neurotol. 2023 Sep 20. doi: 10.1097/MAO.0000000000004020. Online ahead of print.

ABSTRACT

OBJECTIVE: With ongoing national expansions in cochlear implantation (CI) candidacy criteria, more patients qualify for CI today than ever before. Among US veterans and military service members, the prevalence of qualifying degrees of hearing loss secondary to occupational noise exposure exceeds the general population. The primary aim of the current work was to evaluate CI trends across the military health system.

STUDY DESIGN: Database review.

SETTING: Military and civilian practices.

PATIENTS: Department of Defense (DoD) beneficiaries who underwent CI.

MAIN OUTCOME MEASURES: CI rates between 2010 and 2019.

RESULTS: A total of 3,573 cochlear implant operations were performed among DoD beneficiaries from 2010 to 2019. A majority of patients (55%) were older than 64 years, with the next most commonly implanted age group being 0 to 4 years of age (14%). From 2010 to 2019, annual CI increased at a rate of 7.9% per year for all implantation over the study period (r = 0.97, p < 0.0001); there was a statistically significant difference of this rate compared with tympanoplasty, which was used as a reference procedure (rate, -1.9%; p = 0.03). This trend was similar for beneficiaries implanted both in military (11.9% per year, r = 0.77, p = 0.009) and civilian facilities (7.7% per year, r = 0.96, p < 0.0001); there was no statistically significant difference between the annual growth rates of these groups (p = 0.68).

CONCLUSIONS: Although the number of devices implanted is rapidly increasing among DoD beneficiaries, reported national utilization rates remain low. This disparity likely exists in the general public, considering the aging demographic in the West and continual expansions in US Federal Drug Administration labeling. These data suggest that widespread expansion of the procedure to general otolaryngology practices will be required to meet current and future demands for CI. For this reason, CI should be considered for “key indicator” designation among residency training programs.

PMID:37733998 | DOI:10.1097/MAO.0000000000004020

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Nevin Manimala Statistics

Can Serum Chitotriosidase Levels, Immune and Oxidative Stress Parameters Be Early Diagnostic Indicators in Patients With Silicosis?

J Occup Environ Med. 2023 Sep 19. doi: 10.1097/JOM.0000000000002973. Online ahead of print.

ABSTRACT

OBJECTIVE: We aimed to evaluate the enzyme activity of chitotriosidase as a biomarker in early diagnosis silicosis, and to investigate immune system response and oxidative stress caused by silica exposure.

MATERIALS AND METHODS: Silicosis patients (n = 116), exposed to silica without disease (n = 76), and healthy individuals(n = 55) were included. Serum levels of chitotriosidase, proinflammatory cytokines, oxidant-antioxidant and immune parameters were measured.

RESULTS: Serum chitotriosidase enzyme levels in the silicosis group were statistically significantly higher than the exposure and control groups. Inflammatory biomarkers, 8-hydroxy-2-deoxyguanosine levels were found to be statistically significantly higher in the silicosis and exposure group compared to the controls, while superoxide dismutase and glutathione peroxidase were lower.

CONCLUSION: Increased serum chitotriosidase level emerged as a biomarker that can not only distinguish silicosis from exposure and healthy controls, but also indicate early pulmonary effects of silica.

PMID:37733997 | DOI:10.1097/JOM.0000000000002973

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Nevin Manimala Statistics

Design and Implementation of a National Program to Monitor the Prevalence of SARS-CoV-2 IgG Antibodies in England Using Self-Testing: The REACT-2 Study

Am J Public Health. 2023 Sep 21:e1-e9. doi: 10.2105/AJPH.2023.307381. Online ahead of print.

ABSTRACT

Data System. The UK Department of Health and Social Care funded the REal-time Assessment of Community Transmission-2 (REACT-2) study to estimate community prevalence of SARS-CoV-2 IgG (immunoglobulin G) antibodies in England. Data Collection/Processing. We obtained random cross-sectional samples of adults from the National Health Service (NHS) patient list (near-universal coverage). We sent participants a lateral flow immunoassay (LFIA) self-test, and they reported the result online. Overall, 905 991 tests were performed (28.9% response) over 6 rounds of data collection (June 2020-May 2021). Data Analysis/Dissemination. We produced weighted estimates of LFIA test positivity (validated against neutralizing antibodies), adjusted for test performance, at local, regional, and national levels and by age, sex, and ethnic group and area-level deprivation score. In each round, fieldwork occurred over 2 weeks, with results reported to policymakers the following week. We disseminated results as preprints and peer-reviewed journal publications. Public Health Implications. REACT-2 estimated the scale and variation in antibody prevalence over time. Community self-testing and -reporting produced rapid insights into the changing course of the pandemic and the impact of vaccine rollout, with implications for future surveillance. (Am J Public Health. Published online ahead of print September 21, 2023:e1-e9. https://doi.org/10.2105/AJPH.2023.307381).

PMID:37733993 | DOI:10.2105/AJPH.2023.307381

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Nevin Manimala Statistics

Feasibility of Symptom Monitoring During the First Year of Endocrine Therapy for Early Breast Cancer Using Patient-Reported Outcomes Collected via Smartphone App

JCO Oncol Pract. 2023 Sep 21:OP2300038. doi: 10.1200/OP.23.00038. Online ahead of print.

ABSTRACT

PURPOSE: Treatment-associated symptoms drive early discontinuation of adjuvant endocrine therapy (ET) for breast cancer. We hypothesized that symptom monitoring with electronic patient-reported outcomes (ePROs) during adjuvant ET will enhance symptom detection, symptom management, and persistence.

METHODS: Eligible patients were initiating ET for stage 0-III breast cancer. Participants completed ePRO surveys via smartphone at baseline and 1, 3, 6, and 12 months. Measures included Patient-Reported Outcomes Measurement Information System Anxiety, Depression, Fatigue, and Vaginal Discomfort; plus Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events items assessing joint pain, hot flashes, vaginal dryness, concentration problems, and memory problems. Scores surpassing prespecified thresholds triggered alerts, and recommended symptom management pathways were provided to clinicians. The primary objective was to evaluate feasibility, assessed by survey completion rates, with targets of >65% for the baseline survey and ≥1 follow-up survey during the first 6 months. Secondary objectives included 12-month ET discontinuation rate (target: ≤15%), describing symptoms and evaluating pathway implementation.

RESULTS: Among 250 participants, 73.2% completed the baseline survey and 69.6% completed ≥1 follow-up survey during the first 6 months. Thirty-one percent of participants had ≥1 symptom alert at baseline and 74% had ≥1 symptom alert during follow-up. The proportions of participants for whom pathway-concordant symptom management was documented at each time point ranged from 12.8% to 36.6%. Twenty-eight participants (11.2%) discontinued ET by 12 months.

CONCLUSION: Symptom monitoring with ePROs during adjuvant ET is feasible. Despite infrequent documentation of pathway-concordant symptom management after symptom alerts, ePROs were associated with favorable short-term ET persistence.

PMID:37733984 | DOI:10.1200/OP.23.00038

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Pretest Video Education Versus Genetic Counseling for Patients With Prostate Cancer: ProGen, A Multisite Randomized Controlled Trial

JCO Oncol Pract. 2023 Sep 21:OP2300007. doi: 10.1200/OP.23.00007. Online ahead of print.

ABSTRACT

PURPOSE: Germline genetic testing (GT) is recommended for men with prostate cancer (PC), but testing through traditional models is limited. The ProGen study examined a novel model aimed at providing access to GT while promoting education and informed consent.

METHODS: Men with potentially lethal PC (metastatic, localized with a Gleason score of ≥8, persistent prostate-specific antigen after local therapy), diagnosis age ≤55 years, previous malignancy, and family history suggestive of a pathogenic variant (PV) and/or at oncologist’s discretion were randomly assigned 3:1 to video education (VE) or in-person genetic counseling (GC). Participants had 67 genes analyzed (Ambry), with results disclosed via telephone by a genetic counselor. Outcomes included GT consent, GT completion, PV prevalence, and survey measures of satisfaction, psychological impact, genetics knowledge, and family communication. Two-sided Fisher’s exact tests were used for between-arm comparisons.

RESULTS: Over a 2-year period, 662 participants at three sites were randomly assigned and pretest VE (n = 498) or GC (n = 164) was completed by 604 participants (VE, 93.1%; GC, 88.8%), of whom 596 participants (VE, 98.9%; GC, 97.9%) consented to GT and 591 participants completed GT (VE, 99.3%; GC, 98.6%). These differences were not statistically significant although subtle differences in satisfaction and psychological impact were. Notably, 84 PVs were identified in 78 participants (13.2%), with BRCA1/2 PV comprising 32% of participants with a positive result (BRCA2 n = 21, BRCA1 n = 4).

CONCLUSION: Both VE and traditional GC yielded high GT uptake without significant differences in outcome measures of completion, GT uptake, genetics knowledge, and family communication. The increased demand for GT with limited genetics resources supports consideration of pretest VE for patients with PC.

PMID:37733980 | DOI:10.1200/OP.23.00007

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Nevin Manimala Statistics

Enhancing Efficiency and Reach Using Facebook to Recruit Breast Cancer Survivors for a Telephone-Based Supportive Care Randomized Trial During the COVID-19 Pandemic

JCO Oncol Pract. 2023 Sep 21:OP2300117. doi: 10.1200/OP.23.00117. Online ahead of print.

ABSTRACT

PURPOSE: Evidence supporting social media-based recruitment of cancer survivors is limited. This paper describes how we used Facebook during the COVID-19 pandemic to augment our recruitment of breast cancer survivors for our two-site telephone-based randomized clinical trial (RCT) at Dartmouth-Hitchcock Medical Center and the University of Alabama at Birmingham.

METHODS: Originally a two-site RCT of a telephone-delivered breast cancer survivorship intervention, we extended our clinic-based recruitment to Facebook. Participant characteristics, geographic reach, and baseline outcomes were compared across recruitment sources (ie, two clinics and Facebook) using descriptive statistics and effect sizes.

RESULTS: Enrollment rates (20%-29%) were comparable across recruitment sources. The 21-month Facebook marketing campaign accounted for 59% (n = 179/303) of our total sample and had the greatest geographic reach, recruiting women from 24 states. The Facebook campaign reached a total of 51,787 unique individuals and cost $88.44 in US dollars (USD) per enrolled participant. Clinic samples had a greater proportion of women who were widowed (8% v 1%; P = .03) and Facebook had a higher proportion of women with a household income over $40,000 USD (83% v 71%; P = .02). There were no statistically significant differences between Facebook and the two clinics on baseline survey scores.

CONCLUSION: Augmenting traditional recruitment with Facebook increased our RCT’s geographic and sociodemographic reach and supported meeting recruitment goals in a timely way. In the wake of the COVID-19 pandemic, cancer survivorship researchers should consider using social media as a recruitment strategy while weighing the advantages and potential biases introduced through such strategies.

PMID:37733975 | DOI:10.1200/OP.23.00117

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Nevin Manimala Statistics

Correlating Vestibular Migraine Patient Assessment Tool and Handicap Inventory to Daily Dizziness Symptoms

Otol Neurotol. 2023 Sep 15. doi: 10.1097/MAO.0000000000004014. Online ahead of print.

ABSTRACT

OBJECTIVE: Investigate the relationship between Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) scores and daily dizziness symptoms.

STUDY DESIGN: Prospective cohort analysis of 52 patients with vestibular migraine (VM).

SETTING: Tertiary referral center.

PATIENTS: Fifty-two patients diagnosed with VM or probable VM according to Barany Society criteria.

INTERVENTIONS: Subjects reported their dizzy symptoms (on a scale of 0 [no symptoms], 1 [mild], 2 [moderate], and 3 [severe]) every day for 1 month via automated text messaging linked to a cloud-based research database. Subjects completed VM-PATHI and Dizziness Handicap Inventory (DHI) scores at the end of the month. We examined the correlation between a composite of daily dizziness scores with VM-PATHI and DHI scores through linear regression and correlation analysis.

MAIN OUTCOME MEASURES: Pearson correlation coefficient, R2 value.

RESULTS: VM-PATHI showed a moderate correlation with daily dizziness symptoms (correlation coefficient, 0.51). DHI showed a lower correlation with daily dizziness (correlation coefficient, 0.38). VM-PATHI score was a strong predictor of daily dizziness with univariate linear regression (R2 = 0.26, p = 0.001). In a multiple linear regression model with age, history of anxiety and/or depression, and VM-PATHI, the VM-PATHI score was the only statistically significant predictor of daily dizziness (p < 0.001).

CONCLUSIONS: Daily dizziness symptoms are better correlated with VM-PATHI score than the DHI, providing further validation of VM-PATHI as a disease-specific outcome measure for patients with VM.

PMID:37733970 | DOI:10.1097/MAO.0000000000004014