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Nevin Manimala Statistics

Pott’s Puffy: First Shot is the Best Shot

J Craniofac Surg. 2023 Jun 12. doi: 10.1097/SCS.0000000000009451. Online ahead of print.

ABSTRACT

OBJECTIVE: Low incidence of Pott’s Puffy tumor (PPT) has caused studying risk factors and recurrences of the disease to be difficult. We used the comparatively increased incidence at our institution to evaluate potential risk factors for the disease process itself and prognostic factors for recurrence of the disease.

METHODS: Single institutional retrospective chart review identified 31 patients from 2010 to 2022 with PPT compared with a control group of 20 patients with either chronic rhinosinusitis or recurrent sinusitis. Patient mean age of PPT was 42 (range of 5 to 90) with the majority of the patient population as male (74%) and Caucasian (68%) in the setting of rural West Texas. Patient mean age of the control group was 50.7 (range of 30-78) with majority of patient population as male (55%) and Caucasian (70%). Interventions studied were functional endoscopic sinus surgery (FESS), FESS with trephination, and cranialization with or without FESS to compare prognostic factors for recurrence rates of PPT. These patients’ prognostic risk factors for recurrence and risk factors to develop PPT were analyzed using Analysis of Variance (ANOVA) χ2 statistical analysis with Fischer exact testing.

RESULTS: Mean age was 42 years (range of 5-90) with the majority of the PPT patient population as male (74%) and Caucasian (68%) with an overall incidence of about 1 in 300,000. Pott’s Puffy tumor patients were significantly favored in the younger and male population compared with the control patients. Risk factors of no prior allergy diagnosis, previous trauma, medication allergy to penicillin class or cephalosporin class, and lower body mass index were significant in the PPT population compared with the control group. Significant prognostic factors for recurrence of PPT were prior history of sinus surgery and operative treatment choice. Fifty percent (3/6) of patients with prior sinus surgery had recurrence of PPT. Of our 4 treatment options (FESS, FESS with trephination, FESS with cranialization, or cranialization alone), ;FESS had a recurrence of PPT of 0% (0/13), FESS with trephination had a recurrence of PPT of 50% (3/6), FESS with cranialization had a recurrence of PPT of 11% (1/9), and cranizalization alone had a recurrence of PPT of 0% (0/3). Of note, postop chronic rhinosinusitis was seen in 46% (6/13) of FESS alone, 17% (1/6) with FESS with trephination, 0% (0/9) with FESS with cranialization, and 33% (1/3) with just cranialization alone.

CONCLUSIONS: Pott’s Puffy tumor patients were younger and predominately male when compared to the control patients. No prior allergy diagnosis, previous trauma history, medication allergy to penicillin class or cephalosporin class, and lower body mass index are risk factors for PPT. There are 2 prognostic factors that predict recurrence of PPT: first operative treatment choice and prior sinus surgery. History of prior sinus surgery tends to increase the recurrence of PPT. The first operative treatment plan is the best shot at definitively treating PPT. Correct management surgically can prevent recurrence of PPT as well as long-term recurrence of chronic rhinosinusitis. With early diagnosis and mild disease, FESS is sufficient to prevent recurrence of PPT but chronic sinusitis may continue to occur if frontal sinus outflow track is not well opened. If considering trephination, a definitive cranialization may be more suited for more advanced disease since our study showed 50% of recurrence of PPT with trephination and FESS along with 17% chronic sinusitis long term. More advanced diseases with higher WBCs and intracranial extension do better with more aggressive surgical management with a cranialization with or without FESS which shows to reduce rates of PPT recurrence significantly.

PMID:37307535 | DOI:10.1097/SCS.0000000000009451

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Nevin Manimala Statistics

The Efficacy of a Diet Low in Fermentable Oligo-, Di-, Monosaccharides, and Polyols in Irritable Bowel Syndrome Compared to Its “Real-world” Effectiveness: Protocol for a Systematic Review

JMIR Res Protoc. 2023 Jun 12;12:e41399. doi: 10.2196/41399.

ABSTRACT

BACKGROUND: Irritable bowel syndrome (IBS) is associated with various gastrointestinal and nongastrointestinal symptoms and reduced quality of life. A diet low in fermentable oligo-, di-, monosaccharides, and polyols (FODMAPs) is one therapeutic option for IBS. Although the efficacy of the low FODMAP diet has been reported in several systematic reviews, the efficacy-effectiveness gap of the low FODMAP diet has not yet been assessed.

OBJECTIVE: This systematic review aims to compare the efficacy of the low FODMAP diet from efficacy randomized controlled trials (RCTs) with the effectiveness of studies conducted in “real-world” settings.

METHODS: RCTs, prospective and retrospective cohort studies, and retrospective audits assessing the low FODMAP diet in adults with IBS will be searched in 4 databases: Embase, MEDLINE, CENTRAL, and CINAHL. Two independent reviewers will perform study selection, data extraction, and risk of bias assessment and assess selected quality aspects from the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) protocol. Outcomes assessed are stool frequency, stool consistency, abdominal pain, overall symptom scores, adequate symptom relief, IBS-specific quality of life, and diet adherence. Data will be summarized with forest plots without summary statistics, tables, and narrative descriptions.

RESULTS: The search, title and abstract screening, and full-text screening were completed in March 2021, and an updated search was done in May 2022. As of May 2023, data analysis is almost finished, and manuscript writing is in progress. Submission of the manuscript is expected by July 2023.

CONCLUSIONS: The findings of this systematic review will compare the efficacy of the low FODMAP diet for IBS found in RCTs to the diet’s real-world effectiveness.

TRIAL REGISTRATION: PROSPERO CRD42021278952; https://tinyurl.com/32jk43ev.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41399.

PMID:37307063 | DOI:10.2196/41399

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Nevin Manimala Statistics

Consumers’ Needs for Laboratory Results Portals: Questionnaire Study

JMIR Hum Factors. 2023 Jun 12;10:e42843. doi: 10.2196/42843.

ABSTRACT

BACKGROUND: Over the last decade, there has been an increase in the number of health care consumers (ie, patients, citizens, and laypeople) with access to their laboratory results through portals. However, many portals are not designed with the consumer in mind, which can limit communication effectiveness and consumer empowerment.

OBJECTIVE: We aimed to study design facilitators and barriers affecting consumer use of a laboratory results portal. We sought to identify modifiable design attributes to inform future interface specifications and improve patient safety.

METHODS: A web-based questionnaire with open- and closed-ended items was distributed to consumers in British Columbia, Canada. Open-ended items with affinity diagramming and closed-ended questions with descriptive statistics were analyzed.

RESULTS: Participants (N=30) preferred reviewing their laboratory results through portals rather than waiting to see their provider. However, respondents were critical of the interface design (ie, interface usability, information completeness, and display clarity). Scores suggest there are display issues impacting communication that require urgent attention.

CONCLUSIONS: There are modifiable usability, content, and display issues associated with laboratory results portals that, if addressed, could arguably improve communication effectiveness, patient empowerment, and health care safety.

PMID:37307049 | DOI:10.2196/42843

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Nevin Manimala Statistics

New Web-Based System for Recording Public Health Nursing Practices and Determining Best Practices: Protocol of an Exploratory Sequential Design

JMIR Res Protoc. 2023 Jun 12;12:e45342. doi: 10.2196/45342.

ABSTRACT

BACKGROUND: Digitalization and information and communication technology (ICT) promote effective, efficient individual and community care. Clinical terminology or taxonomy and its framework visualize individual patients’ and nursing interventions’ classifications to improve their outcomes and care quality. Public health nurses (PHNs) provide lifelong individual care and community-based activities while developing projects to promote community health. The linkage between these practices and clinical assessment remains tacit. Owing to Japan’s lagging digitalization, supervisory PHNs face difficulties in monitoring each department’s activities and staff members’ performances and competencies. Randomly selected prefectural or municipal PHNs collect data on daily activities and required hours every 3 years. No study has adopted these data for public health nursing care management. PHNs need ICTs to manage their work and improve care quality; it may help identify health needs and suggest best public health nursing practices.

OBJECTIVE: We aim to develop and validate an electronic recording and management system for evaluating different public health nursing practice needs, including individual care, community-based activities, and project development, and for determining their best practices.

METHODS: We used a 2-phase exploratory sequential design (in Japan) comprising 2 phases. In phase 1, we developed the system’s architectural framework and a hypothetical algorithm to determine the need for practice review through a literature review and a panel discussion. We designed a cloud-based practice recording system, including a daily record system and a termly review system. The panels included 3 supervisors who were prior PHNs at the prefectural or municipal government, and 1 was the executive director of the Japanese Nursing Association. The panels agreed that the draft architectural framework and hypothetical algorithm were reasonable. The system was not linked to electronic nursing records to protect patient privacy. Phase 2 validated each item through interviews with supervisory PHNs using a web-based meeting system. A nationwide survey was distributed to supervisory and midcareer PHNs across local governments.

RESULTS: This study was funded in March 2022 and approved by all ethics review boards from July to September and November 2022. Data collection was completed in January 2023. Five PHNs participated in the interviews. In the nationwide survey, responses were obtained from 177 local governments of supervisory PHNs and 196 midcareer ones.

CONCLUSIONS: This study will reveal PHNs’ tacit knowledge about their practices, assess needs for different approaches, and determine best practices. Additionally, this study will promote ICT-based practices in public health nursing. The system will enable PHNs to record their daily activities and share them with their supervisors to reflect on and improve their performance, and the quality of care to promote health equity in community settings. The system will support supervisory PHNs in creating performance benchmarks for their staff and departments to promote evidence-based human resource development and management.

TRIAL REGISTRATION: UMIN-ICDR UMIN000049411; https://tinyurl.com/yfvxscfm.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45342.

PMID:37307040 | DOI:10.2196/45342

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Nevin Manimala Statistics

Add-on Rehmannia-6-Based Chinese Medicine in Type 2 Diabetes and CKD: A Multicenter Randomized Controlled Trial

Clin J Am Soc Nephrol. 2023 Jun 12. doi: 10.2215/CJN.0000000000000199. Online ahead of print.

ABSTRACT

BACKGROUND: Diabetes is the leading cause of chronic kidney disease (CKD) and kidney failure We assessed the real-world effectiveness of Rehmannia-6-based Chinese medicine treatment, the most used Chinese medicine formulation, on the change in estimated glomerular filtration rate (eGFR) and albuminuria in diabetic CKD patients with severely increased albuminuria.

METHODS: In this randomized, assessor-blind, standard care-controlled, parallel, multi-center trial, 148 adult patients from outpatient clinics with type 2 diabetes, estimated glomerular filtration rate (eGFR) of 30-90 ml/min/1.73m2 and urinary albumin-to-creatinine ratio (UACR) of 300-5000 mg/g were randomized 1:1 to a 48-week add-on protocolized Chinese medicine treatment program (using Rehmannia-6-based formulations in granule form taken orally) or standard care alone. Primary outcomes were the slope of change in eGFR and UACR between baseline and endpoint (48 weeks after randomization) in the intention-to-treat population. Secondary outcomes included safety, and the change in biochemistry, biomarkers and concomitant drug use.

RESULTS: The mean age, eGFR and UACR were 65 years, 56.7 ml/min/1.73m2 and 753 mg/g, respectively. 95% (n=141) of endpoint primary outcome measures were retrievable. For eGFR, the estimated slope of change was -2.0 (95%CI: -0.1 to -3.9) and -4.7 (95%CI: -2.9 to -6.5) ml/min/1.73m2 in participants treated with add-on Chinese medicine or standard care alone, resulting a 2.7 ml/min/1.73m2 per year (95%CI: 0.1 to 5.3, p=0.04) less decline with Chinese medicine. For UACR, the estimated proportion in the slope of change was 0.88 (0.75 to 1.02) and 0.99 (0.85 to 1.14) in participants treated with add-on Chinese medicine or standard care alone. The inter-group proportional difference (0.89, 11% slower increment in add-on Chinese medicine, 95%CI: 0.72 to 1.10, p=0.28) did not reach statistical significance. 85 adverse events were recorded from 50 participants (add-on Chinese medicine vs control: 22 (31%) vs 28 (36%)).

CONCLUSIONS: Rehmannia-6-based Chinese medicine treatment stabilized eGFR on top of standard care alone after 48 weeks in patients with type 2 diabetes, stage 2 to 3 chronic kidney disease and severely increased albuminuria.

CLINICAL TRIAL REGISTRY: Semi-individualised Chinese Medicine Treatment as an Adjuvant Management for Diabetic Nephropathy (SCHEMATIC), NCT02488252.

PMID:37307005 | DOI:10.2215/CJN.0000000000000199

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Nevin Manimala Statistics

Statistical and Conceptual Considerations in Socioepigenomics Research on Childhood Adversity and Epigenetic Aging

JAMA Netw Open. 2023 Jun 1;6(6):e2317958. doi: 10.1001/jamanetworkopen.2023.17958.

NO ABSTRACT

PMID:37307003 | DOI:10.1001/jamanetworkopen.2023.17958

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Nevin Manimala Statistics

Epidemiology of Cancer-Associated Venous Thromboembolism in Patients With Solid and Hematologic Neoplasms in the Veterans Affairs Health Care System

JAMA Netw Open. 2023 Jun 1;6(6):e2317945. doi: 10.1001/jamanetworkopen.2023.17945.

ABSTRACT

IMPORTANCE: Identifying changes in epidemiologic patterns of the incidence and risk of cancer-associated thrombosis (CAT), particularly with evolving cancer-directed therapy, is essential for risk stratification.

OBJECTIVE: To assess the incidence of CAT over time and to determine pertinent patient-specific, cancer-specific, and treatment-specific factors associated with its risk.

DESIGN, SETTING, AND PARTICIPANTS: This longitudinal, retrospective cohort study was conducted from 2006 to 2021. Duration of follow-up was from the date of diagnosis until first venous thromboembolism (VTE) event, death, loss of follow-up (defined as a 90-day gap without clinical encounters), or administrative censoring on April 1, 2022. The study took place within the US Department of Veterans Affairs national health care system. Patients with newly diagnosed invasive solid tumors and hematologic neoplasms were included in the study. Data were analyzed from December 2022 to February 2023.

EXPOSURE: Newly diagnosed invasive solid tumors and hematologic neoplasms.

MAIN OUTCOMES: Incidence of VTE was assessed using a combination of International Classification of Diseases, Ninth Revision, Clinical Modification and International Statistical Classification of Diseases, Tenth Revision, Clinical Modification and natural language processing confirmed outcomes. Cumulative incidence competing risk functions were used to estimate incidence of CAT. Multivariable Cox regression models were built to assess the association of baseline variables with CAT. Pertinent patient variables included demographics, region, rurality, area deprivation index, National Cancer Institute comorbidity index, cancer type, staging, first-line systemic treatment within 3 months (time-varying covariate), and other factors that could be associated with the risk of VTE.

RESULTS: A total of 434 203 patients (420 244 men [96.8%]; median [IQR] age, 67 [62-74] years; 7414 Asian or Pacific Islander patients [1.7%]; 20 193 Hispanic patients [4.7%]; 89 371 non-Hispanic Black patients [20.6%]; 313 157 non-Hispanic White patients [72.1%]) met the inclusion criteria. Overall incidence of CAT at 12 months was 4.5%, with yearly trends ranging stably from 4.2% to 4.7%. The risk of VTE was associated with cancer type and stage. In addition to confirming well-known risk distribution among patients with solid tumors, a higher risk of VTE was observed among patients with aggressive lymphoid neoplasms compared with patients with indolent lymphoid or myeloid hematologic neoplasms. Compared with no treatment, patients receiving first-line chemotherapy (hazard ratio [HR], 1.44; 95% CI, 1.40-1.49) and immune checkpoint inhibitors (HR, 1.49; 95% CI, 1.22-1.82) had a higher adjusted relative risk than patients receiving targeted therapy (HR, 1.21; 95% CI, 1.13-1.30) or endocrine therapy (HR, 1.20; 95% CI, 1.12-1.28). Finally, adjusted VTE risk was significantly higher among Non-Hispanic Black patients (HR, 1.23; 95% CI, 1.19-1.27) and significantly lower in Asian or Pacific Islander patients (HR, 0.84; 95% CI, 0.76-0.93) compared with Non-Hispanic White patients.

CONCLUSIONS AND RELEVANCE: In this cohort study of patients with cancer, a high incidence of VTE was observed, with yearly trends that remained stable over the 16-year study period. Both novel and known factors associated with the risk of CAT were identified, providing valuable and applicable insights in this current treatment landscape.

PMID:37306999 | DOI:10.1001/jamanetworkopen.2023.17945

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Nevin Manimala Statistics

Neighborhood Food Environment and Birth Weight Outcomes in New York City

JAMA Netw Open. 2023 Jun 1;6(6):e2317952. doi: 10.1001/jamanetworkopen.2023.17952.

ABSTRACT

IMPORTANCE: Infants born with unhealthy birth weight are at greater risk for long-term health complications, but little is known about how neighborhood characteristics (eg, walkability, food environment) may affect birth weight outcomes.

OBJECTIVE: To assess whether neighborhood-level characteristics (poverty rate, food environment, and walkability) are associated with risk of unhealthy birth weight outcomes and to evaluate whether gestational weight gain mediated these associations.

DESIGN, SETTING, AND PARTICIPANTS: The population-based cross-sectional study included births in the 2015 vital statistics records from the New York City Department of Health and Mental Hygiene. Only singleton births and observations with complete birth weight and covariate data were included. Analyses were performed from November 2021 to March 2022.

EXPOSURES: Residential neighborhood-level characteristics, including poverty, food environment (healthy and unhealthy food retail establishments), and walkability (measured by both walkable destinations and a neighborhood walkability index combining walkability measures like street intersection and transit stop density). Neighborhood-level variables categorized into quartiles.

MAIN OUTCOMES AND MEASURES: The main outcomes were birth certificate birth weight measures including small for gestational age (SGA), large for gestational age (LGA), and sex-specific birth weight for gestational age z-score. Generalized linear mixed-effects models and hierarchical linear models estimated risk ratios for associations between density of neighborhood-level characteristics within a 1-km buffer of residential census block centroid and birth weight outcomes.

RESULTS: The study included 106 194 births in New York City. The mean (SD) age of pregnant individuals in the sample was 29.9 (6.1) years. Prevalence of SGA and LGA were 12.9% and 8.4%, respectively. Residence in the highest density quartile of healthy food retail establishments compared with the lowest quartile was associated with lower adjusted risk of SGA (with adjustment for individual covariates including gestational weight gain z-score: risk ratio [RR], 0.89; 95% CI 0.83-0.97). Higher neighborhood density of unhealthy food retail establishments was associated with higher adjusted risk of delivering an infant classified as SGA (fourth vs first quartile: RR, 1.12; 95% CI, 1.01-1.24). The RR for the association between density of unhealthy food retail establishments and risk of LGA was higher after adjustment for all covariates in each quartile compared with quartile 1 (second: RR, 1.12 [95% CI, 1.04-1.20]; third: RR, 1.18 [95% CI, 1.08-1.29]; fourth: RR, 1.16; [95% CI, 1.04-1.29]). There were no associations between neighborhood walkability and birth weight outcomes (SGA for fourth vs first quartile: RR, 1.01 [95% CI, 0.94-1.08]; LGA for fourth vs first quartile: RR, 1.06 [95% CI, 0.98-1.14]).

CONCLUSIONS AND RELEVANCE: In this population-based cross-sectional study, healthfulness of neighborhood food environments was associated with risk of SGA and LGA. The findings support use of urban design and planning guidelines to improve food environments to support healthy pregnancies and birth weight.

PMID:37306998 | DOI:10.1001/jamanetworkopen.2023.17952

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Independent Associations of Incident Epilepsy and Enzyme-Inducing and Non-Enzyme-Inducing Antiseizure Medications With the Development of Osteoporosis

JAMA Neurol. 2023 Jun 12. doi: 10.1001/jamaneurol.2023.1580. Online ahead of print.

ABSTRACT

IMPORTANCE: Both epilepsy and enzyme-inducing antiseizure medications (eiASMs) having varying reports of an association with increased risks for osteoporosis.

OBJECTIVE: To quantify and model the independent hazards for osteoporosis associated with incident epilepsy and eiASMS and non-eiASMs.

DESIGN, SETTING, AND PARTICIPANTS: This open cohort study covered the years 1998 to 2019, with a median (IQR) follow-up of 5 (1.7-11.1) years. Data were collected for 6275 patients enrolled in the Clinical Practice Research Datalink and from hospital electronic health records. No patients who met inclusion criteria (Clinical Practice Research Datalink-acceptable data, aged 18 years or older, follow-up after the Hospital Episode Statistics patient care linkage date of 1998, and free of osteoporosis at baseline) were excluded or declined.

EXPOSURE: Incident adult-onset epilepsy using a 5-year washout and receipt of 4 consecutive ASMs.

MAIN OUTCOMES AND MEASURES: The outcome was incident osteoporosis as determined through Cox proportional hazards or accelerated failure time models where appropriate. Incident epilepsy was treated as a time-varying covariate. Analyses controlled for age, sex, socioeconomic status, cancer, 1 or more years of corticosteroid use, body mass index, bariatric surgery, eating disorders, hyperthyroidism, inflammatory bowel disease, rheumatoid arthritis, smoking status, falls, fragility fractures, and osteoporosis screening tests. Subsequent analyses (1) excluded body mass index, which was missing in 30% of patients; (2) applied propensity score matching for receipt of an eiASM; (3) restricted analyses to only those with incident onset epilepsy; and (4) restricted analyses to patients who developed epilepsy at age 65 years or older. Analyses were performed between July 1 and October 31, 2022, and in February 2023 for revisions.

RESULTS: Of 8 095 441 adults identified, 6275 had incident adult-onset epilepsy (3220 female [51%] and 3055 male [49%]; incidence rate, 62 per 100 000 person-years) with a median (IQR) age of 56 (38-73) years. When controlling for osteoporosis risk factors, incident epilepsy was independently associated with a 41% faster time to incident osteoporosis (time ratio [TR], 0.59; 95% CI, 0.52-0.67; P < .001). Both eiASMs (TR, 0.91; 95% CI, 0.87-0.95; P < .001) and non-eiASMs (TR, 0.77; 95% CI, 0.76-0.78; P < .001) were also associated with significant increased risks independent of epilepsy, accounting for 9% and 23% faster times to development of osteoporosis, respectively. The independent associations among epilepsy, eiASMs, and non-eiASMs remained consistent in propensity score-matched analyses, cohorts restricted to adult-onset epilepsy, and cohorts restricted to late-onset epilepsy.

CONCLUSIONS AND RELEVANCE: These findings suggest that epilepsy is independently associated with a clinically meaningful increase in the risk for osteoporosis, as are both eiASMs and non-eiASMs. Routine screening and prophylaxis should be considered in all people with epilepsy.

PMID:37306981 | DOI:10.1001/jamaneurol.2023.1580

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Nevin Manimala Statistics

Transmissibility of mpox to the general population from travellers returning to South Korea

J Travel Med. 2023 Jun 12:taad080. doi: 10.1093/jtm/taad080. Online ahead of print.

NO ABSTRACT

PMID:37306962 | DOI:10.1093/jtm/taad080