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Nevin Manimala Statistics

Incremental Benefits of Machine Learning-When Do We Need a Better Mousetrap?

JAMA Cardiol. 2021 Mar 10. doi: 10.1001/jamacardio.2021.0139. Online ahead of print.

NO ABSTRACT

PMID:33688913 | DOI:10.1001/jamacardio.2021.0139

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Stepped Collaborative Care Targeting Posttraumatic Stress Disorder Symptoms and Comorbidity for US Trauma Care Systems: A Randomized Clinical Trial

JAMA Surg. 2021 Mar 10. doi: 10.1001/jamasurg.2021.0131. Online ahead of print.

ABSTRACT

IMPORTANCE: To date, few multisite investigations have evaluated early interventions for injured patients with posttraumatic stress disorder (PTSD) symptoms.

OBJECTIVE: To simultaneously assess the effectiveness and implementation of a brief stepped collaborative care intervention targeting PTSD and comorbidity.

DESIGN, SETTING, AND PARTICIPANTS: A stepped-wedge cluster randomized clinical trial was conducted at 25 US level I trauma centers. Participants included hospitalized survivors of physical injury who underwent a 2-step evaluation for PTSD symptoms. Patients reporting high levels of distress on the PTSD Checklist (PCL-C) were randomized (N = 635) per the stepped-wedge protocol to enhanced usual care control (n = 370) or intervention (n = 265) conditions. The study was conducted from January 4, 2016, through November 2018. Data analysis was performed from November 4, 2019, to December 8, 2020.

INTERVENTIONS: The Trauma Survivors Outcomes and Support collaborative care intervention included proactive injury case management that assisted patients transitioning from hospital inpatient to outpatient and community settings. The intervention also integrated evidence-based pharmacotherapy and psychotherapeutic elements targeting PTSD symptoms and comorbidity.

MAIN OUTCOMES AND MEASURES: The primary study outcome was PTSD symptoms assessed with the PCL-C at baseline in the surgical ward and at 3, 6, and 12 months postinjury. Secondary outcomes included depressive symptoms, alcohol use, and physical function. Subgroup analyses examined the effect of baseline risk factors for enduring PTSD and quality of protocol implementation on study outcomes. Primary statistical analyses were conducted using the intent-to-treat sample.

RESULTS: A total of 327 men (51.5%) were included in analysis; mean (SD) age was 39.0 (14.2) years. The investigation attained follow-up of 75% to 80% of the participants at 3 to 12 months. The intervention lasted a mean (SD) of 122 (132) minutes. Mixed model regression analyses revealed statistically significant changes in PCL-C scores for intervention patients compared with control patients at 6 months (difference, -2.57; 95% CI, -5.12 to -0.03; effect size, 0.18; P < .05) but not 12 months (difference, -1.27; 95% CI, -4.26 to 1.73; effect size, 0.08; P = .35). Subgroup analyses revealed larger PTSD treatment effects for patients with 3 or more baseline risk factors for enduring PTSD and for patients, including firearm injury survivors, treated at trauma centers with good or excellent protocol implementation. Intervention effects for secondary outcomes did not attain statistical significance.

CONCLUSIONS AND RELEVANCE: A brief stepped collaborative care intervention was associated with significant 6-month but not 12-month PTSD symptom reductions. Greater baseline PTSD risk and good or excellent trauma center protocol implementation were associated with larger PTSD treatment effects. Orchestrated efforts targeting policy and funding should systematically incorporate the study findings into national trauma center requirements and verification criteria.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02655354.

PMID:33688908 | DOI:10.1001/jamasurg.2021.0131

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No Evidence for a Decrease in Physical Activity Among Swiss Office Workers During COVID-19: A Longitudinal Study

Front Psychol. 2021 Feb 11;12:620307. doi: 10.3389/fpsyg.2021.620307. eCollection 2021.

ABSTRACT

PURPOSE: The COVID-19 lockdown interrupted normal daily activities, which may have led to an increase in sedentary behavior (Castelnuovo et al., 2020). The aim of this study was to investigate the effect of the COVID-19 pandemic on the level of physical activity among Swiss office workers.

METHODS: Office workers from two Swiss organizations, aged 18-65 years, were included. Baseline data from January 2020 before the COVID-19 pandemic became effective in Switzerland were compared with follow-up data during the lockdown phase in April 2020. Levels of physical activity were assessed using the International Physical Activity Questionnaire. Paired sample t-tests or Wilcoxon signed-rank test were performed for statistical analysis.

RESULTS: Data from 76 participants were analyzed. Fifty-four participants were female (71.1%). The mean age was 42.7 years (range from 21.8 to 62.7) at baseline. About 75% of the participants met the recommendations on minimal physical activity, both before the COVID-19 pandemic and during the lockdown. Weak statistical evidence for a decline in total physical activity in metabolic equivalent of task minutes per week (MET min/week) was found (estimate = -292, 95% CI from – ∞ to 74, p-value = 0.09), with no evidence for a decrease in the three types of activity: walking (estimate = -189, 95% CI from – ∞ to 100, p-value = 0.28), moderate-intensity activity (estimate = -200, 95% CI from – ∞ to 30, p-value = 0.22) and vigorous-intensity activity (estimate = 80, 95% CI from – ∞ to 460, p-value = 0.74). Across the three categories “high,” “moderate,” and “low” physical activity, 17% of the participants became less active during the lockdown while 29% became more active.

CONCLUSION: The COVID-19 pandemic did not result in a reduction in total physical activity levels among a sample of Swiss office workers during the first weeks of lockdown. Improved work-life balance and working times may have contributed to this finding.

CLINICAL TRIAL REGISTRATION: www.ClinicalTrials.gov, NCT04169646. Registered 15 November 2019 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04169646.

PMID:33688857 | PMC:PMC7928288 | DOI:10.3389/fpsyg.2021.620307

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Outcome trends in people with heart failure, type 2 diabetes mellitus and chronic kidney disease in the UK over twenty years

EClinicalMedicine. 2021 Feb 4;32:100739. doi: 10.1016/j.eclinm.2021.100739. eCollection 2021 Feb.

ABSTRACT

BACKGROUND: Heart failure (HF) together with type 2 diabetes (T2D) and chronic kidney disease (CKD) are major pandemics of the twenty first century. It is not known in people with new onset HF, what the distinct and combined associations are between T2D and CKD comorbidities and cause-specific hospital admissions and death, over the past 20 years.

METHODS: An observational study using the UK Clinical Practice Research Datalink linked to the Hospital Episode Statistics in England (1998-2017). Participants were people aged ≥30 years with new onset HF. Exposure groups were HF with: (i) no T2D and no CKD (reference group); (ii) CKD-only (estimated glomerular filtration rate (eGFR) <60 ml/min per 1.73 m2); (iii) T2D-only; (iv) T2D and CKD. CKD severity groups were: CKD-3a (eGFR 45-59); CKD-3b (30-44); CKD-4 (15-29); CKD-5 (<15). Outcomes were cardiovascular and non-cardiovascular hospitalisations and all-cause death.

FINDINGS: In 87,709 HF patients (mean age, 78 years; 49% female), 40% had CKD-only, 12% T2D-only, and 16% both. Age-standardised first-year CVD hospitalisation rates were significantly higher in HF patients with CKD-only (46.4; 95% CI 44.9,47.9 per 100 person years) and T2D-only (49.2; 46.7,58.8) than in the reference group (35.1; 34.0,36.1); the highest rate was in patients with T2D-CKD-5: 89.1 (65.8,112.4). Similar patterns were observed for non-CVD hospitalisations and deaths. Group differences remained significant after adjustment for potential confounders. Median survival was highest in the reference (4.4 years) and HF-T2D-only (4.1 years) groups, compared to HF-CKD-only (2.2 years). HF-T2D-CKD group survival ranged from 2.8 (CKD-3a) to 0.7 years (CKD-5). Over time, CVD hospitalisation rates significantly increased for HF-CKD-only (+26%) and reduced (-24%) for HF-T2D-only groups; no reductions were observed in any of the HF-T2D-CKD groups. Trends were similar for non-CVD hospitalisations and death: whilst death rates significantly reduced for HF-T2D-only (-37%), improvement was not observed in any of the T2D-CKD groups.

INTERPRETATION: In a cohort of people with new onset HF, hospitalisations and deaths are high in patients with T2D or CKD, and worst in those with both comorbidities. Whilst outcomes have improved over time for patients with HF and comorbid T2D, similar trends were not seen in those with comorbid CKD. Strategies to prevent and manage CKD in people with HF are urgently needed.

FUNDING: NIHR fellowship [reference: NIHR 30011].

PMID:33688855 | PMC:PMC7910705 | DOI:10.1016/j.eclinm.2021.100739

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Mobile App-Based Intervention for Pregnant Women With Stress Urinary Incontinence: Protocol for a Hybrid Effectiveness-Implementation Trial

JMIR Res Protoc. 2021 Mar 10;10(3):e22771. doi: 10.2196/22771.

ABSTRACT

BACKGROUND: Stress urinary incontinence (SUI) is a common source of distress among women during and after pregnancy. It has a negative effect on quality of life but with poor care-seeking. Mobile health (mHealth) may be a promising solution with potential advantages. However, there is uncertainty whether a mobile app is effective for SUI symptom improvement during and after pregnancy. The implementation is also unclear. We developed an app named UIW (Urinary Incontinence for Women) aimed at improving perinatal incontinence.

OBJECTIVE: The objective of this study is to evaluate the effectiveness of the UIW app-based intervention in improving SUI symptoms among pregnant women and explore the facilitators and barriers to using the UIW app to help refine and optimize the intervention.

METHODS: This study is a hybrid effectiveness-implementation trial with a randomized controlled trial alongside a mixed-methods process evaluation according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Pregnant women with SUI (n=336) will be recruited from a university-affiliated hospital in China. They will be randomly allocated (1:1) to either the intervention group that receive usual care plus UIW app or control group that receive usual care alone. The intervention period will last 2 months. The 5 dimensions of the RE-AIM framework will be evaluated at recruitment (-T1), baseline (T0), immediately after intervention (T1), 42 days after delivery (T2), 3 months after delivery (T3), and 6 months after delivery (T4) through project documents, online questionnaires and a pelvic floor muscle training diary, surface electromyography, log data in the background management system, and qualitative interviews. Data analysis will follow the intention-to-treat principle. Descriptive statistics, t tests, chi-square tests, and a linear mixed model will be used to analyze the quantitative data. Deductive and inductive content analysis will be used to analyze the qualitative data.

RESULTS: The effectiveness-implementation trial started in June 2020, trial recruitment was completed in October 2020, and the intervention will last for a 2-month period. Completion of the 6-month follow-up will be in July 2021, and we anticipate that the results of this study will be published in December 2021.

CONCLUSIONS: This study will evaluate both effectiveness and implementation of the UIW app-based intervention among pregnant women. The hybrid effectiveness-implementation trial design according to the RE-AIM framework with a mixed-methods approach will give valuable insights into the effects as well as facilitators and barriers to the implementation that will influence the effects of the UIW app-based intervention.

TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1800016171; http://www.chictr.org.cn/showproj.aspx?proj=27455.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/22771.

PMID:33688842 | DOI:10.2196/22771

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Minimal clinically important difference of the 6-min walking test in patients with asthma

Int J Tuberc Lung Dis. 2021 Mar 1;25(3):215-221. doi: 10.5588/ijtld.20.0928.

ABSTRACT

BACKGROUND: The 6-min walking test (6MWT) is responsive to physiological changes and pulmonary rehabilitation (PR) in patients with asthma. The minimal clinically important difference (MCID) has not been established yet.OBJECTIVE: To determine the MCID of 6MWT in patients with asthma.METHODS: Using the perceived change in walking ability and the modified Medical Research Council (mMRC) score as anchors, receiver operating characteristic curves and quantile regression, we evaluated 6MWT before and after PR in these patients. The St George Respiratory Questionnaire (SGRQ), the COPD assessment test (CAT) and other outcome measures were also assessed.RESULTS: Of 142 patients with asthma, 37 were enrolled. After PR, 6MWT increased from 453.4 m ± 88.8 to 493.0 m ± 97.2 (P = 0.0001); other outcome measures also increased. There was a slight correlation between baseline 6MWT and SGRQ, CAT and mMRC. No significant correlations were found between post-PR changes in 6MWT and in other outcome measures. Comparing different methods of assessment, the MCID ranged from 26 m to 27 m.CONCLUSION: The most conservative estimate of the MCID of 6MWT after PR was 26 m in patients with asthma. This estimate may be useful in clinical interpretation of data, particularly in response to intervention studies.

PMID:33688810 | DOI:10.5588/ijtld.20.0928

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Implication of efflux pumps and ERG11 genes in resistance of clinical Trichosporon asahii isolates to fluconazole

J Med Microbiol. 2021 Mar 10. doi: 10.1099/jmm.0.001236. Online ahead of print.

ABSTRACT

Introduction. Trichosporon asahii has been recognized as an opportunistic agent having a limited sensitivity to antifungal treatment.Hypothesis/Gap Statement. Molecular mechanisms of azole resistance have been rarely reported for Trichosproron asahii. Similar to other fungi, we hypothesized that both ERG11 gene mutation and efflux pumps genes hyper-expression were implicated.Aim. The current work aimed to study the sensitivity of clinical T. asahii isolates to different antifungal agents and to explore their resistance mechanisms by molecular methods including real-time PCR and gene sequencing.Methods. The sensitivity of T. asahii isolates to fluconazole, amphotericin B and voriconazole was estimated by the Etest method. Real-time PCR was used to measure the relative expression of Pdr11, Mdr and ERG11 genes via the ACT1 housekeeping gene. Three pairs of primers were also chosen to sequence the ERG11 gene. This exploration was followed by statistical study including the receiver operating characteristic (ROC) curve analysis to identify a relationship between gene mean expression and the sensitivity of isolates.Results. In 31 clinical isolates, the resistance frequencies were 87, 16.1 and 3.2 %, respectively, for amphotericin B, fluconazole and voriconazole. Quantitative real-time PCR demonstrated that only Mdr over-expression was significantly associated with FCZ resistance confirmed by univariate statistical study and the ROC curve analysis (P <0.05). The ERG11 sequencing revealed two mutations H380G and S381A in TN325U11 (MIC FCZ=8 µg ml-1) and H437R in TN114U09 (MIC FCZ=256 µg ml-1) in highly conserved regions (close to the haem-binding domain) but their involvement in the resistance mechanism has not yet been assigned.Conclusion. T. asahii FCZ resistance mechanisms are proven to be much more complex and gene alteration sequence and/or expression can be involved. Only Mdr gene over-expression was significantly associated with FCZ resistance and no good correlation was observed between FCZ and VCZ MIC values and relative gene expression. ERG11 sequence alteration seems to play a major role in T. asahii FCZ resistance mechanism but their involvement needs further confirmation.

PMID:33688802 | DOI:10.1099/jmm.0.001236

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Effects of liver transplantation on sexual function and quality of life

Psychol Health Med. 2021 Mar 10:1-12. doi: 10.1080/13548506.2021.1898003. Online ahead of print.

ABSTRACT

This descriptive study aimed to determine patients’ sexual dysfunction and quality of life before and after liver transplantation. The study was conducted with 64 patients who underwent liver transplantation at a university hospital between January 2015 and 2019. The patients were aged 18 or over, able to answer relevant questions and volunteered to participate in the study. The population of the study included patients who underwent liver transplantation on the specified dates and agreed to participate in the study. Descriptive Characteristics Form, Short Form-36 (SF-36), Female Sexual Function Index (FSFI) and International Index of Erectile Function (IIEF) were used for data collection. A significant increase was found in all subscale scores of males on the IIEF scale after transplantation (p = 0.000). The total FSFI score of the females was 24.27 ± 18.60 before transplantation and 29.62 ± 25.19 after transplantation. The results were not statistically significant (p = 0.072). After transplantation, a highly significant increase was observed in the Physical Component Summary and Mental Component Summary subscale scores of the SF-36 both in males and females (p = 0.000). An increase was observed in the sexual functions of males and females after transplantation. A statistically significant increase was found in the mean scores of both males and females on the quality of life after transplantation (p = 0.000). This study concluded that sexual functions of male (p < 0.05) and female (p > 0.05) patients improved after transplantation.

PMID:33688768 | DOI:10.1080/13548506.2021.1898003

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Mining pre-surgical patterns able to discriminate post-surgical outcomes in the oncological domain

IEEE J Biomed Health Inform. 2021 Mar 9;PP. doi: 10.1109/JBHI.2021.3064786. Online ahead of print.

ABSTRACT

Understanding the individualized risks of undertaking surgical procedures is essential to personalize preparatory, intervention and post-care protocols for minimizing post-surgical complications. This knowledge is key in oncology given the nature of interventions, the fragile profile of patients with comorbidities and cytotoxic drug exposure, and the possible cancer recurrence. Despite its relevance, the discovery of discriminative patterns of post-surgical risk is hampered by major challenges: i) the unique physiological and demographic profile of individuals, as well as their differentiated post-surgical care; ii) the high-dimensionality and heterogeneous nature of available biomedical data, combining non-identically distributed risk factors, clinical and molecular variables; iii) the need to generalize tumors have significant histopathological differences and individuals undertake unique surgical procedures; iv) the need to focus on non-trivial patterns of post-surgical risk, while guaranteeing their statistical significance and discriminative power; and v) the lack of interpretability and actionability of current approaches. Biclustering, the discovery of groups of individuals correlated on subsets of variables, has unique properties of interest, being positioned to satisfy the aforementioned challenges. In this context, this work proposes a structured view on why, when and how to apply biclustering to mine discriminative patterns of post-surgical risk with guarantees of usability, a subject remaining unexplored up to date. These patterns offer a comprehensive view on how the patient profile, cancer histopathology and entailed surgical procedures determine: i) post-surgical complications, ii) survival, and iii) hospitalization needs. The gathered results confirm the role of biclustering in comprehensively finding interpretable, actionable and statistically significant patterns of post-surgical risk. The found patterns are already assisting healthcare professionals at IPO-Porto to establish specialized pre-habilitation protocols and bedside care.

PMID:33687853 | DOI:10.1109/JBHI.2021.3064786

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Dielectric properties of human active liver, kidney and spleen compared to those of respective inactive tissues, porcine tissues and the data provided by a database in the frequency range of 10Hz to 100MHz

IEEE Trans Biomed Eng. 2021 Mar 9;PP. doi: 10.1109/TBME.2021.3065016. Online ahead of print.

ABSTRACT

OBJECTIVE: The purpose of this work is to study whether the active state and species of biological tissues can influence changes in their dielectric properties.

METHODS: In this paper, the dielectric properties of liver, kidney and spleen tissues from human active, human inactive and animal tissues are measured in the frequency range of 10 Hz to 100 MHz. The four- and two-electrode methods are used to measure dielectric properties at different frequencies. Statistical analysis and the pattern recognition method are used to compare the dielectric properties of human active tissues, human inactive tissues, animal tissues and data provided by the IFAC database.

RESULTS: The results show that the dielectric properties of human active tissues are significantly different from those of human inactive tissues and animal tissues, resulting in a great difference between the dielectric properties provided by the IFAC database and those of human active tissues. The dielectric properties of human active tissues can be identified by the pattern recognition method based on principal component analysis, which further proves that the dielectric properties of human active tissues cannot be replaced.

CONCLUSION: The dielectric properties of biological tissues are closely related to the activity and species of tissues. The dielectric properties of human active tissues cannot be replaced by those of human cadaver tissues or animal tissues.

SIGNIFICANCE: The significance of this study is suggesting that the IFAC database should be updated with the dielectric properties of human active tissues to provide accurate data for bioelectromagnetics research.

PMID:33687834 | DOI:10.1109/TBME.2021.3065016