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Nevin Manimala Statistics

Risk of immune reconstitution inflammatory syndrome with integrase inhibitors versus other classes of antiretrovirals: a systematic review and meta-analysis of randomised trials

J Acquir Immune Defic Syndr. 2022 Feb 14. doi: 10.1097/QAI.0000000000002937. Online ahead of print.

ABSTRACT

BACKGROUND: Integrase strand transfer inhibitors (InSTIs) decrease HIV plasma viral load faster than other antiretroviral classes. More rapid viral load decline has been associated with higher risk of immune reconstitution inflammatory syndrome (IRIS). There are conflicting reports on the association between InSTI and IRIS. We performed a systematic review and meta-analysis to compare the risk of IRIS among treatment-naïve HIV-positive patients starting InSTI versus non-InSTI regimens.

METHODS: We searched PubMed, Scopus, Web of Science, Africa-Wide, and Cochrane databases from earliest available date to 26 November 2021, for randomised controlled trials (RCTs) having intervention arms with InSTI versus control arms without InSTI in patients initiating first-line antiretroviral therapy. The primary outcome was relative risk (RR) of IRIS, while the secondary outcome was RR of paradoxical tuberculosis-associated IRIS (TB-IRIS). Data were combined by random-effects meta-analysis according to the Mantel-Haenszel method. The protocol for this study is registered with PROSPERO, CRD42020213976.

RESULTS: We included 14 RCTs comprising 8696 participants from six continents for the primary outcome of IRIS, and a subset of 674 participants (from three RCTs) for the secondary outcome of paradoxical TB-IRIS. Risk of IRIS was similar between InSTI and non-InSTI regimens (RR, 0.93, 95% confidence interval [CI], 0.75 – 1.14). There was a trend towards a lower risk of paradoxical TB-IRIS with InSTI versus efavirenz regimens that was not statistically significant (RR, 0.64, 95% CI, 0.34 – 1.19).

CONCLUSIONS: In this meta-analysis among treatment-naïve patients commencing first-line antiretroviral therapy, InSTI regimens were not associated with higher risk of IRIS.

PMID:35175970 | DOI:10.1097/QAI.0000000000002937

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Botulinum Toxin Type A Injection in the Treatment of Postparetic Facial Synkinesis: An Integrative Review

Am J Phys Med Rehabil. 2022 Mar 1;101(3):284-293. doi: 10.1097/PHM.0000000000001840.

ABSTRACT

This study aimed to review the recent literature about botulinum toxin type A treatment patterns, including muscle targets, doses, duration of effect, adverse effects, and clinical outcomes in patients with postparetic synkinesis. A bibliographic research of studies published in the last 10 yrs was carried out on PubMed database, using the medical subject heading terms: botulinum toxin and synkinesis. English-language cohort studies or randomized controlled trials about botulinum toxin type A treatment on patients with postparetic synkinesis were eligible for inclusion. Ten studies met the inclusion criteria, seven prospective studies, two retrospective studies, and one randomized controlled trial, involving 23-99 patients. The target facial muscles included frontalis, corrugator supercilli, orbicularis oculi, levator labii superioris, zygomaticus major, orbicularis oris, risorius, buccinator, depressor anguli oris, depressor labii inferioris, mentalis, and platysma. The dose of onabotulinumtoxinA administered per injection site ranged between 0.5 and 10 U. Adverse effects were rare and temporary. The mean duration of onabotulinumtoxinA effect ranges from 66 days to 4 mos. There was a statistically significant improvement in posttreatment evaluation, both in objective and subjective assessments. There is scientific evidence of the benefit of botulinum toxin type A treatment for postparetic synkinesis, but there is lack of standardized treatment protocols.

PMID:35175961 | DOI:10.1097/PHM.0000000000001840

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Robotic Assisted versus Manual Percutaneous Coronary Intervention – Systematic Review and Meta-Analysis

Cardiol Rev. 2022 Feb 11. doi: 10.1097/CRD.0000000000000445. Online ahead of print.

ABSTRACT

INTRODUCTION: Robotics in percutaneous coronary intervention (R-PCI) has been one such area of advancement where potential benefits may include reduced operator radiation exposure, improved outcomes, and reduced rate of adverse events. Limited data exist about the benefits of R-PCI vs. conventional manual PCI (M-PCI). We appraised the latest evidence in the form of a meta-analysis of observational and retrospective studies.

METHODS: A comprehensive literature search was performed in PubMed, Embase, and Cochrane to identify relevant clinical studies. Summary effects were calculated using a DerSimonian and Laird random-effects model as the pooled odds ratio or mean differences with 95% confidence intervals. All studies adhering to the inclusion criteria of direct comparisons between R-PCI and M-PCI were evaluated.

RESULTS: Seven studies with a total of 2,230 patients were identified. There was significant decrease in the chest-level operator radiation exposure (MD= -442.32; 95% CI = -675.88 to -208.76), fluoroscopy time (MD = -1.46; 95% CI -2.92 to 0.00) and amount of contrast used (MD= -18.28; 95% CI -24.16 to -12.41) in the robotic group as compared to the manual group. PCI time and the procedural success rate was not statistically different between the two groups. Clinical outcomes of major adverse cardiac events, all-cause mortality, and myocardial infarction were not different between the two groups.

CONCLUSION: Robotic PCI is associated with reduced operator radiation exposure, fluoroscopy time, and amount of contrast used. While there is a significant reduction in the procedural characteristics with robotic PCI, the clinical outcomes are not different compared to manual PCI. R-PCI is safe and effective with potential benefits to both the operator and the patient simultaneously.

PMID:35175955 | DOI:10.1097/CRD.0000000000000445

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Combinatorial Investigation of the Ni-Ta System via Correlated High-Speed Nanoindentation and EDX Mapping

Small Methods. 2022 Feb;6(2):e2101084. doi: 10.1002/smtd.202101084. Epub 2021 Nov 28.

ABSTRACT

Correlated high-speed nanoindentation and energy-dispersive spectroscopy are applied in a combinatorial investigation of the Ni-Ta system. All seven phases in the system are clearly resolved in the resulting maps, and the mechanical properties and composition ranges for each phase are determined. Good agreement with ab initio calculations is generally observed with some exceptions, most notably NiTa2 . This is achieved using a simple correlation method utilizing directly overlaid data matrices to allow compositional labeling of mechanical data. This allows easy data segmentation without requiring complicated statistical deconvolution methods. Without this correlative method, phase deconvolution of the Ni-Ta system would be challenging due to several phases possessing adjacent compositions and mechanical properties. This demonstrates the potential of this new correlative approach for future investigations, particularly those involving complex microstructures and/or compositional variation.

PMID:35174994 | DOI:10.1002/smtd.202101084

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Posterior corneal vesicles are not associated with the genetic variants that cause posterior polymorphous corneal dystrophy

Acta Ophthalmol. 2022 Feb 17. doi: 10.1111/aos.15114. Online ahead of print.

ABSTRACT

PURPOSE: Posterior corneal vesicles (PCVs) have clinical features that are similar to posterior polymorphous corneal dystrophy (PPCD). To help determine whether there is a shared genetic basis, we screened 38 individuals with PCVs for changes in the three genes identified as causative for PPCD.

METHODS: We prospectively recruited patients for this study. We examined all individuals clinically, with their first-degree relatives when available. We used a combination of Sanger and exome sequencing to screen regulatory regions of OVOL2 and GRHL2, and the entire ZEB1 coding sequence.

RESULTS: The median age at examination was 37.5 years (range 4.7-84.0 years), 20 (53%) were male and in 19 (50%) the PCVs were unilateral. Most individuals were discharged to optometric review, but five had follow-up for a median of 12 years (range 5-13 years) with no evidence of progression. In cases with unilateral PCVs, there was statistically significant evidence that the change in the affected eye was associated with a lower endothelial cell density (p = 0.0003), greater central corneal thickness (p = 0.0277) and a steeper mean keratometry (p = 0.0034), but not with a higher keratometric astigmatism or a reduced LogMAR visual acuity. First-degree relatives of 13 individuals were available for examination, and in 3 (23%), PCVs were identified. No possibly pathogenic variants were identified in the PPCD-associated genes screened.

CONCLUSION: We found no evidence that PCVs share the same genetic background as PPCD. In contrast to PPCD, we confirm that PCVs is a mild, non-progressive condition with no requirement for long-term review. However, subsequent cataract surgery can lead to corneal oedema.

PMID:35174971 | DOI:10.1111/aos.15114

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Depressive symptoms and stress among nurses in the COVID unit: A 7-month cohort study

Jpn J Nurs Sci. 2022 Feb 17:e12477. doi: 10.1111/jjns.12477. Online ahead of print.

ABSTRACT

AIM: Previous studies have reported high prevalence of depression and anxiety symptoms among frontline nurses caring for COVID-19 patients. Yet, only a limited number of prospective studies examining nurses’ mental health problems have been performed. The present study aimed to examine depressive symptoms and COVID-19-related stresses among nurses working specifically in a hospital COVID unit over a 7-month period.

METHODS: In this study, depressive symptoms and COVID-19-related stresses of a total of 28 nurses who worked in the COVID unit were assessed using the Quick Inventory of Depressive Symptom (QIDS) and the Tokyo Metropolitan Distress Scale for Pandemic (TMDP) over the 7-month period from December 2020 to June 2021.

RESULTS: The mean QIDS scores in all participants fluctuated during the study period, showing a high correlation with the reported number of new COVID-19 cases in the region. The mean TMDP scores showed a gradual decline over the period. Scores on the social stress factor of the TMDP demonstrated a statistically significant correlation with the QIDS scores.

CONCLUSIONS: The results indicate that the number of new COVID-19 patients in the region is associated with depressive symptoms among nurses in the hospital COVID unit. Scores on the social stress factor in the TMDP are also correlated with depressive symptoms among nurses.

PMID:35174968 | DOI:10.1111/jjns.12477

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Nurse admissions at a specialized mental health programme: A pre-Covid-19 retrospective review (2000-2019)

J Adv Nurs. 2022 Feb 17. doi: 10.1111/jan.15189. Online ahead of print.

ABSTRACT

AIMS: Nursing is a stressful and emotionally demanding profession. To date, few mental health treatment interventions have been developed for them worldwide. This study aims to explore referral trends in nurses with mental disorders admitted to a pioneer specialized mental health programme in Europe from 2000 to 2019.

DESIGN: A retrospective observational study of 1297 medical e-records of nurses with mental health disorders admitted to the Galatea Care Programme in Barcelona was conducted.

METHODS: Three periods were analysed: 2000-2006, 2007-2012 and 2013-2019. Socio-demographic and clinical variables were compared. Diagnoses followed Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria.

RESULTS: Gender and age at referral did not change over time. Self-referrals grew from 85.1% in the first period to 95.3% in the last period; inpatient admissions decreased from 24.1% to 18.2%, although this was not significant; nurses were less frequently on sick leave on admission over time (59.1% vs. 45.7%); they were more likely to have a temporary contract in the second period (9.5% vs. 4.8% and 4%) and prevalence of main diagnosis changed with a considerable decrease in affective and substance use disorders after 2006 and a progressive increase in adjustment disorders during the whole period.

CONCLUSION: Free, voluntary, highly confidential programmes for nurses with mental disorders may enhance voluntary and earlier help seeking. These findings can be considered when implementing specialized interventions for them in other settings. WHAT PROBLEM DID THE STUDY ADDRESS?: Nursing is a stressful and emotionally demanding profession. To date, few specialized mental health services have been developed for them worldwide. This study aims to explore referral trends in nurses with mental disorders admitted to a pioneer programme in Europe, the Galatea Care Programme in Barcelona, from 2000 to 2019. WHAT WERE THE MAIN FINDINGS?: The number of referrals to the programme grew especially after the first 7-year period. Admissions were more likely to be voluntary during the last period. Prevalence of substance use disorders at admission dropped steadily while prevalence of adjustment disorders progressively increased over the two decades. Nurses were also less likely to be on sick leave at admission. WHERE AND ON WHOM WILL THE RESEARCH HAVE IMPACT?: Free, voluntary, highly confidential programmes for nurses with mental disorders may enhance voluntary and earlier help seeking. These findings can be considered when implementing specialized interventions for them in other settings.

PMID:35174899 | DOI:10.1111/jan.15189

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Prevalence of electronic device use before bed among Australian children and adolescents: a cross-sectional population level study

Aust N Z J Public Health. 2022 Feb 17. doi: 10.1111/1753-6405.13214. Online ahead of print.

ABSTRACT

OBJECTIVE: To understand the prevalence of children and adolescents’ electronic device use (EDU) in the hour before bed and identify sociodemographic groups that are at increased risk of problematic use.

METHOD: A contemporary population wide sample of South Australian school students aged 8-18 years (n = 70,936) was utilised to present descriptive statistics of EDU before bed across sociodemographic groups. Data was collected from the 2019 Wellbeing and Engagement Collection, an annual self-report census of students’ health, wellbeing and school engagement.

RESULTS: 90% of children used an electronic device in the hour before bed at least one night a week, with 51% using a device every night. Older adolescent females in grades 10-12 were most frequent users and children from the most socioeconomically disadvantaged communities were also more likely to use electronic devices in the hour before bed.

CONCLUSION: EDU before bed is highly prevalent among Australian children and adolescents and given the negative health and educational impacts, it requires immediate and widespread action from policy makers to ensure the health of Australia’s next generation. Implications for public health: The scale of the problem has now been identified; next steps rely on a public health approach to address this issue. This might include awareness raising campaigns and targeted interventions towards at-risk groups.

PMID:35174930 | DOI:10.1111/1753-6405.13214

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Association of the Cerebro-Placental Ratio with Adverse Outcomes in Pregnancies Affected by Gestational Diabetes Mellitus

J Ultrasound Med. 2022 Feb 17. doi: 10.1002/jum.15961. Online ahead of print.

ABSTRACT

OBJECTIVES: Cerebro-placental ratio (CPR) is a doppler tool contributes to clinical decision-making in pregnancies affected by small for gestational age weight (SGA). Pregnancies affected by gestational diabetes mellitus (GDM) tend to have higher newborn weight, but greater risk of adverse perinatal outcomes. We hypothesized that in GDM-complicated-pregnancies CPR will be associated with adverse perinatal outcomes even in the absence of SGA.

METHODS: This prospective single-center cohort study included non-anomalous singleton pregnancies in women with GDM. Those with pre-pregnancy diabetes mellitus, hypertensive disorder or suspected SGA were excluded. Routine fetal sonographic assessment included CPR-defined as middle cerebral artery pulsatilty index/umbilical artery pulsatilty index. Masked CPR measurement closest to birth was used, classified as >10th (normal) or ≤10th centile (low). Primary outcome was a composite, consisting of stillbirth, Caesarean birth due to abnormal fetal heart rate pattern, 5-minute Apgar <7, cord arterial pH < 7.0, hypoxic ischemic encephalopathy, or NICU admission >24 hours.

RESULTS: Of 281 participants, 24 (8.5%) had low CPR, at a mean gestational age of 36.3 weeks (IQR 34.0-37.4). Birthweight percentile was significantly lower among the low CPR group (35th [IQR 16-31] versus 60th [IQR 31-82]; P = .002). There was no statistically difference in the primary composite outcome between the groups (8.3% versus 7.0%, P = .68). Low CPR was significantly associated with a higher risk of neonatal hypoglycemia (adjusted odds ratio 3.2, 95% CI 1.2-8.3).

CONCLUSION: In pregnancies affected by GDM, CPR ≤10th percentile was not associated with adverse perinatal outcome but was associated with neonatal hypoglycemia.

PMID:35174894 | DOI:10.1002/jum.15961

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Adaptive enrichment designs with a continuous biomarker

Biometrics. 2022 Feb 17. doi: 10.1111/biom.13644. Online ahead of print.

ABSTRACT

A popular design for clinical trials assessing targeted therapies is the two-stage adaptive enrichment design with recruitment in stage two limited to a biomarker-defined subgroup chosen based on data from stage one. The data-dependent selection leads to statistical challenges if data from both stages are used to draw inference on treatment effects in the selected subgroup. If subgroups considered are nested, as when defined by a continuous biomarker, treatment effect estimates in different subgroups follow the same distribution as estimates in a group-sequential trial. This result is used to obtain tests controlling the familywise type I error rate (FWER) for six simple subgroup selection rules, one of which also controls the FWER for any selection rule. Two approaches are proposed; one based on multivariate normal distributions suitable if the number of possible subgroups, k, is small, and one based on Brownian motion approximations suitable for large k. The methods, applicable in the wide range of settings with asymptotically normal test statistics, are illustrated using survival data from a breast cancer trial. This article is protected by copyright. All rights reserved.

PMID:35174875 | DOI:10.1111/biom.13644