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Nevin Manimala Statistics

Behavioural observation tool for patient involvement and collaboration in emergency care teams (PIC-ET-tool)

BMC Emerg Med. 2023 Jul 1;23(1):74. doi: 10.1186/s12873-023-00841-7.

ABSTRACT

BACKGROUND: Patient participation is advocated in various healthcare settings. Instruments for assessment and feedback have been developed to strengthen clinician-patient interaction. In an emergency department context, such instruments are still missing. The study aimed to develop and test an observation tool for emergency teams’ behaviour regarding patient involvement and collaboration.

METHODS: The development of the behavioural observation tool followed a systematic approach. The tool’s content was based on various data sources, i.e., published literature, interview and observational data, and expert consensus. An international expert panel reviewed the content and the rating scale and rated its importance for patient involvement and collaboration in a Delphi process. The feasibility and reliability of the tool were tested by trained observers using video recordings of simulated emergencies. Intraclass correlation (ICC) and Kappa-statistics were performed to test the tool’s inter-rater reliability.

RESULTS: The PIC-ET tool, a 22-item observation instrument was developed in which patient involvement and collaboration behaviours are rated from ‘no’ to ‘high’ using behavioural anchors. Expert agreement was obtained after three Delphi rounds on the tool content, the behavioural anchors and its importance for patient involvement and collaboration. The content validity was assessed as high, and the tool was found feasible for research. Overall inter-rater reliability was fair (Kappa 0.52).

CONCLUSIONS: A novel tool for assessing emergency teams’ behaviour regarding patient involvement and collaboration is introduced. The tool’s psychometric properties were fair to good. Further validation of the PIC-ET tool is recommended for more robust evidence. Future adaptation to different contexts and areas of use, as well as further validity testing may be of value.

PMID:37393240 | DOI:10.1186/s12873-023-00841-7

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Immunogenicity of adjuvanted versus high-dose inactivated influenza vaccines in older adults: a randomized clinical trial

Immun Ageing. 2023 Jul 1;20(1):30. doi: 10.1186/s12979-023-00355-7.

ABSTRACT

BACKGROUND: Adjuvanted inactivated influenza vaccine (aIIV) and high-dose inactivated influenza vaccine (HD-IIV) are U.S.-licensed for adults aged ≥ 65 years. This study compared serum hemagglutination inhibition (HAI) antibody titers for the A(H3N2) and A(H1N1)pdm09 and B strains after trivalent aIIV3 and trivalent HD-IIV3 in an older adult population.

RESULTS: The immunogenicity population included 342 participants who received aIIV3 and 338 participants who received HD-IIV3. The proportion of participants that seroconverted to A(H3N2) vaccine strains after allV3 (112 participants [32.8%]) was inferior to the proportion of participants that seroconverted after HD-IIV3 (130 participants [38.5%]) at day 29 after vaccination (difference, – 5.8%; 95%CI, – 12.9% to 1.4%). There were no significant differences between the vaccine groups in percent seroconversion to A(H1N1)pdm09 or B vaccine strains, in percent seropositivity for any of the strains, or in post-vaccination GMT for the A(H1N1)pdm09 strain. The GMTs for the post-vaccination A(H3N2) and B strains were higher after HD-IIV than after aIIV3.

CONCLUSIONS: Overall immune responses were similar after aIIV3 and HD-IIV3. For the primary outcome, the aIIV3 seroconversion rate for H3N2 did not meet noninferiority criteria compared with HD-IIV3, but the HD-IIV3 seroconversion rate was not statistically superior to the aIIV3 seroconversion rate.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03183908.

PMID:37393237 | DOI:10.1186/s12979-023-00355-7

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Changes in the mean incidence and variance of orthopedic diseases before and during the COVID-19 pandemic in Korea: a retrospective study

BMC Musculoskelet Disord. 2023 Jul 1;24(1):540. doi: 10.1186/s12891-023-06634-0.

ABSTRACT

BACKGROUND: During the coronavirus disease (COVID-19) pandemic, the amount of moderate- to high-intensity physical activity significantly decreased. Therefore, the epidemiology of musculoskeletal diseases could possibly have changed. We assessed changes in the incidence of and variance in non-traumatic orthopedic diseases before and after the COVID-19 pandemic in Korea.

METHODS: This study included data from the Korea National Health Insurance Service, which covers the entire Korean population (approximately 50 million), from January 2018 to June 2021. Using International Classification of Diseases, Tenth Revision codes, 12 common orthopedic diseases were evaluated, including cervical disc disorders, lumbar disc disorders, forward head posture, myofascial pain syndrome, carpal tunnel syndrome, tennis elbow, frozen shoulder, rheumatoid arthritis, gout, hip fracture, distal radius fracture, and spine fracture diseases. “Pre-COVID-19” was the period until February 2020, and “COVID-19 pandemic period” was the period starting March 2020. Differences in the mean incidence and variance of diseases before and during the COVID-19 pandemic were compared.

RESULTS: In most cases, the incidence of orthopedic diseases decreased at the beginning of the pandemic and then increased thereafter. Among the 12 diseases, the incidence of three diseases showed a statistically significant change. The incidence of myofascial pain syndrome (P < 0.001) was lower during the COVID-19 pandemic than during the pre-COVID-19 period. The incidences of frozen shoulder (P < 0.001) and gout (P = 0.043) were higher during the COVID-19 pandemic than during the pre-COVID-19 period. However, no statistical difference in disease variations was observed between the two periods.

CONCLUSIONS: The incidence of orthopedic diseases varied during the COVID-19 pandemic among the Korean population. Although the incidence of myofascial pain syndrome was lower, that of frozen shoulder and gout was higher during the COVID-19 pandemic than during the pre-COVID-19 period. No disease variations during the COVID-19 pandemic were found.

PMID:37393227 | DOI:10.1186/s12891-023-06634-0

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COVID-19 pandemic has disrupted the continuity of care for chronic patients: evidence from a cross-sectional retrospective study in a developing country

BMC Prim Care. 2023 Jul 1;24(1):137. doi: 10.1186/s12875-023-02086-6.

ABSTRACT

BACKGROUND: Any disruption in continuity of care for patients with chronic conditions can lead to poor outcomes for the patients as well as great damage for the community and the health system. This study aims to determine the continuity of care for patients with chronic conditions such as hypertension and diabetes during COVID-19 pandemic.

METHODS: Through a cross-sectional retrospective study, data registered in six health centers in Yazd, Iran were analyzed. Data included the number of patients with chronic conditions (hypertension and diabetes) and average daily admission during a year before COVID-19 pandemic and the similar period after COVID-19 outbreak. The experience of continuity of care was assessed applying a validated questionnaire from a sample of 198 patients. Data analysis was done using SPSS version 25. Descriptive statistics, independent T-Test and Multivariable regression were used for analysis.

FINDINGS: Results indicate that both visit load of the patients with chronic conditions (hypertension and diabetes) and their average daily admission were decreased significantly during a year after COVID-19 pandemic compared to the similar period before COVID-19 outbreak. The moderate average score of the patients` experience towards continuity of care during the pandemic was also reported. Regression analysis showed that age for the diabetes patients and insurance status for the hypertension patients affect the COC mean scores.

CONCLUSION: COVID-19 pandemic causes serious decline in the continuity of care for patients with chronic conditions. Such a deterioration not only can lead to make these patients` condition worse in a long-term period but also it can make irreparable damages to the whole community and the health system. To make the health systems resilient particularly in disasters, serious attention should be taken into consideration among them, developing the tele-health technologies, improving the primary health care capacity, designing the applied responsive models of continuity of care, making multilateral participations and inter-sectoral collaborations, allocating sustainable resources, and enabling the patients with selfcare skills are more highlighted.

PMID:37393225 | DOI:10.1186/s12875-023-02086-6

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Comparison of painful temporomandibular disorders, psychological characteristics, sleep quality, and oral health-related quality of life of patients seeking care before and during the Covid-19 pandemic

BMC Oral Health. 2023 Jul 1;23(1):438. doi: 10.1186/s12903-023-03158-w.

ABSTRACT

BACKGROUND: Literature concerning Temporomandibular disorders (TMDs) and the Covid-19 pandemic is limited and disparate findings related to TMD frequencies, psychological distress, and quality of life were presented. This study investigated the prevalence of painful Temporomandibular disorders (TMDs) and compared the psychological, sleep, and oral health-related quality of life profiles of patients seeking TMD care before and during the Covid-19 pandemic.

METHODS: Data were accrued from consecutive adult patients 12 months before (BC; control) and during (DC; case group) the Covid-19 pandemic. The Diagnostic Criteria for TMDs (DC/TMD), Depression, Anxiety, Stress Scales (DASS)-21, Pittsburgh Sleep Quality Index (PSQI), and Oral Health Impact Profile (OHIP)-TMDs were utilized and statistical analysis was performed using Chi-square/non-parametric tests (α = 0.05).

RESULTS: The prevalence of painful TMDs was 50.8% before and 46.3% during the pandemic. Significant differences in PSQI and OHIP component scores were discerned between the BC and DC groups contingent on TMD pain. Total-DASS was moderately correlated to total-PSQI/OHIP (rs = 0.41-0.63).

CONCLUSION: The covid-19 pandemic did not appear to exacerbate psychological distress but affected sleep and increased unease over TMD dysfunction.

PMID:37393220 | DOI:10.1186/s12903-023-03158-w

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Personal experience with the remote check telehealth in cochlear implant users: from COVID-19 emergency to routine service

Eur Arch Otorhinolaryngol. 2023 Jul 1. doi: 10.1007/s00405-023-08045-2. Online ahead of print.

ABSTRACT

PURPOSE: To critically illustrate the personal experience with using the “Remote Check” application which remotely monitors the hearing rehabilitation level of cochlear implant users at home and further allows clinicians to schedule in-clinic sessions according to the patients’ needs.

METHODS: 12-month prospective study. Eighty adult cochlear implant users (females n = 37, males n = 43; age range 20-77 years) with ≥ 36 months of cochlear implant experience and ≥ 12 months of stable auditory and speech recognition level volunteered for this 12-month long prospective study. For each patient, at the beginning of the study during the in-clinic session to assess the stable aided hearing thresholds and the cochlear implant integrity and patient’s usage, the “Remote Check” assessment baseline values were obtained. “Remote Check” outcomes were collected at different times in the subsequent at-home sessions, to identify the patients that had to reach the Center. Chi-square test has been used for statistical analysis of the comparison of the “Remote Check” outcomes and in-clinic session results.

RESULTS: “Remote Check” application outcomes demonstrated minimal or no differences between all sessions. The at-home Remote Check application reached the same clinical outcomes as the in-clinic sessions in 79 out 80 of participants (99%) with high statistical significance (p < 0.05).

CONCLUSIONS: “Remote Check” application supported hearing monitoring in cochlear implant users that were not able to attend the in-clinic review during COVID-19 pandemic time. This study demonstrates that the application can be a useful routine tool also for clinical follow-up of cochlear implant users with stable aided hearing.

PMID:37393199 | DOI:10.1007/s00405-023-08045-2

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Association of Lung Function with Cognitive Decline and Incident Dementia in the Atherosclerosis Risk in Communities Study

Am J Epidemiol. 2023 Jun 30:kwad140. doi: 10.1093/aje/kwad140. Online ahead of print.

ABSTRACT

We examined the associations between lung function and incident dementia and cognitive decline in 12,688 participants of the ARIC study who provided lung function measurements in 1990-1992. Cognitive tests were administered up to seven times, and dementia was ascertained through 2019. We used shared parameter models to jointly model proportional hazard models and linear mixed-effect models to estimate lung function-associated dementia rate and cognitive change, respectively. Higher forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) were associated with reduced dementia rate (n=2452 developed dementia); hazard ratios per 1L higher FEV1 and FVC were 0.79 (95%CI: 0.71-0.89) and 0.81 (95%CI: 0.74-0.89), respectively. Each 1L higher FEV1 and FVC was associated with 0.08 (95%CI: 0.05-0.12) SD and 0.05 (95%CI: 0.02-0.07) SD attenuation of 30-year cognitive decline, respectively. One percent higher FEV1/FVC was associated with 0.008 (95% CI: 0.004-0.012) SD less cognitive decline. We observed statistical interaction between FEV1 and FVC, suggesting that cognitive declines depended on values of specific FEV1 and FVC (as compared to FEV1, FVC, or FEV1/FVC% models that suggested linear incremental associations). Our findings may have important implications for reducing burden of cognitive decline that is attributable to environmental exposures and associated lung function impairment.

PMID:37392093 | DOI:10.1093/aje/kwad140

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Genome-wide DNA methylation analysis of body composition in Chinese monozygotic twins

Eur J Clin Invest. 2023 Jul 1:e14055. doi: 10.1111/eci.14055. Online ahead of print.

ABSTRACT

BACKGROUND: Little is currently known about epigenetic alterations associated with body composition in obesity. Thus, we aimed to explore epigenetic relationships between genome-wide DNA methylation levels and three common traits of body composition as measured by body fat percentage (BF%), fat mass (FM) and lean body mass (LBM) among Chinese monozygotic twins.

METHODS: Generalized estimated equation model was used to regress the methylation level of CpG sites on body composition. Inference about Causation Through Examination Of Familial Confounding was used to explore the evidence of a causal relationship. Gene expression analysis was further performed to validate the results of differentially methylated genes.

RESULTS: We identified 32, 22 and 28 differentially methylated CpG sites (p < 10-5 ) as well as 20, 17 and eight differentially methylated regions (slk-corrected p < 0.05) significantly associated with BF%, FM and LBM which were annotated to 65 genes, showing partially overlapping. Causal inference demonstrated bidirectional causality between DNA methylation and body composition (p < 0.05). Gene expression analysis revealed significant correlations between expression levels of five differentially methylated genes and body composition (p < 0.05).

CONCLUSIONS: These DNA methylation signatures will contribute to increased knowledge about the epigenetic basis of body composition and provide new strategies for early prevention and treatment of obesity and its related diseases.

PMID:37392072 | DOI:10.1111/eci.14055

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Long-term safety of macitentan in patients with pulmonary hypertension: A meta-analysis of randomised controlled trials

Eur J Clin Invest. 2023 Jul 1:e14059. doi: 10.1111/eci.14059. Online ahead of print.

ABSTRACT

BACKGROUND: Macitentan has demonstrated its effectiveness in patients with pulmonary hypertension (PH), but its safety, especially for long-term use, needs to be further explored. This systematic review and meta-analysis aimed to determine the safety of long-term use of macitentan in patients with PH.

METHODS: A systematic search was made of PubMed, Embase, Cochrane Library and clinicaltrials.gov, without language restrictions. Randomised controlled trials (RCTs) on treatment of PH with macitentan, compared with placebo, were reviewed. Estimated effects of included studies were pooled as risk ratios (RRs), with 95% confidence intervals (CIs).

RESULTS: Six RCTs (enrolling 1003 participants) met the inclusion criteria. Anaemia (RR 3.86, 95% CI 2.05-7.30), headache (RR 1.52, 95% CI 1.02-2.26) and bronchitis (RR 2.24, 95% CI 1.30-3.87) were more frequent in the macitentan groups. There was no statistically significant difference in the proportion of patients with at least one adverse event (AE) or serious adverse event (SAE), AEs leading to discontinuation of study treatment, all-cause death, right ventricular failure (RVF) and peripheral oedema between the two groups.

CONCLUSIONS: The long-term use of macitentan is safe for patients with PH, although with a higher risk of anaemia, headache and bronchitis.

PMID:37392063 | DOI:10.1111/eci.14059

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Deep Learning Nomogram for the Identification of Deep Stromal Invasion in Patients With Early-Stage Cervical Adenocarcinoma and Adenosquamous Carcinoma: A Multicenter Study

J Magn Reson Imaging. 2023 Jul 1. doi: 10.1002/jmri.28882. Online ahead of print.

ABSTRACT

BACKGROUND: Deep stromal invasion (DSI) is one of the predominant risk factors that determined the types of radical hysterectomy (RH). Thus, the accurate assessment of DSI in cervical adenocarcinoma (AC)/adenosquamous carcinoma (ASC) can facilitate optimal therapy decision.

PURPOSE: To develop a nomogram to identify DSI in cervical AC/ASC.

STUDY TYPE: Retrospective.

POPULATION: Six hundred and fifty patients (mean age of 48.2 years) were collected from center 1 (primary cohort, 536), centers 2 and 3 (external validation cohorts 1 and 2, 62 and 52).

FIELD STRENGTH/SEQUENCE: 5-T, T2-weighted imaging (T2WI, SE/FSE), diffusion-weighted imaging (DWI, EPI), and contrast-enhanced T1-weighted imaging (CE-T1WI, VIBE/LAVA).

ASSESSMENT: The DSI was defined as the outer 1/3 stromal invasion on pathology. The region of interest (ROI) contained the tumor and 3 mm peritumoral area. The ROIs of T2WI, DWI, and CE-T1WI were separately imported into Resnet18 to calculate the DL scores (TDS, DDS, and CDS). The clinical characteristics were retrieved from medical records or MRI data assessment. The clinical model and nomogram were constructed by integrating clinical independent risk factors only and further combining DL scores based on primary cohort and were validated in two external validation cohorts.

STATISTICAL TESTS: Student’s t-test, Mann-Whitney U test, or Chi-squared test were used to compare differences in continuous or categorical variables between DSI-positive and DSI-negative groups. DeLong test was used to compare AU-ROC values of DL scores, clinical model, and nomogram.

RESULTS: The nomogram integrating menopause, disruption of cervical stromal ring (DCSRMR), DDS, and TDS achieved AU-ROCs of 0.933, 0.807, and 0.817 in evaluating DSI in primary and external validation cohorts. The nomogram had superior diagnostic ability to clinical model and DL scores in primary cohort (all P < 0.0125 [0.05/4]) and CDS (P = 0.009) in external validation cohort 2.

DATA CONCLUSION: The nomogram achieved good performance for evaluating DSI in cervical AC/ASC.

LEVEL OF EVIDENCE: 3 TECHNICAL EFFICACY: Stage 2.

PMID:37392060 | DOI:10.1002/jmri.28882