Nevin Manimala

Clin Pharmacol Ther. 2021 Sep 22. doi: 10.1002/cpt.2425. Online ahead of print.

ABSTRACT

Clinicians and patients often try a treatment for an initial period to inform longer-term therapeutic decisions. A more rigorous approach involves N-of-1 trials. In these single-patient crossover trials, typically conducted in patients with chronic conditions, individual patients are given candidate treatments in a double-blinded, random sequence of alternating periods to determine the most effective treatment for that patient. However, to date, these trials are rarely done outside of research settings and have not been integrated into general care where they could offer substantial benefit. Designating this classical, N-of-1 trial design as Type 1, there also are new and evolving uses of N-of-1 trials that we designate as Type 2. In these, rather than focusing on optimizing treatment for chronic diseases when multiple approved choices are available, as is typical of Type 1, a Type 2 N-of-1 trial tests treatments designed specifically for a patient with a rare diseases, to facilitate personalized medicine. While the aims differ, both types face the challenge of collecting individual-patient evidence using standard, trusted, widely accepted methods. To fulfill their potential for producing both clinical and research benefits, and to be available for wide use, N-of-1 trials will have to fit into the current healthcare ecosystem. This will require generalizable and accepted processes, platforms, methods, and standards. This also will require sustainable value-based arrangements among key stakeholders. In this article, we review opportunities, stakeholders, issues, and possible approaches that could support general use of N-of-1 trials and deliver benefit to patients and the healthcare enterprise. To assess and expand the benefits of N-of-1 trials, we propose multi-stakeholder meetings, workshops, and the generation of methods, standards, and platforms that would support wider availability and the value of N-of-1 trials.

PMID:34551122 | DOI:10.1002/cpt.2425

Int Nurs Rev. 2021 Sep;68(3):267-269. doi: 10.1111/inr.12702.

ABSTRACT

The International Council of Nurses is in a unique position to represent nurses at the World Health Organization, and its task has never been more urgent than this year. Amid the global COVID-19 pandemic, the death rates of nurses and other health care workers are truly shocking, with around 115 000 deaths. However, many countries do not collect statistics on health and care workers’ deaths and infections from COVID-19, so the full extent of this awful situation is not known. At this year’s World Health Assembly, the body that sets the World Health Organization’s agenda for the following year, the International Council of Nurses’ 50-strong delegation voiced the concerns of nurses and ensured that the views and advice of nurses were heard by the World Health Organization’s 194 member states’ delegates. Here, the International Council of Nurses’ Chief Executive Officer Howard Catton describes how the Council is influencing health and care policy worldwide. He urges nurses everywhere to hold their politicians to account.

PMID:34551116 | DOI:10.1111/inr.12702

Sleep. 2021 Sep 22:zsab232. doi: 10.1093/sleep/zsab232. Online ahead of print.

ABSTRACT

STUDY OBJECTIVES: Increased phase synchronization in electroencephalography (EEG) bands might reflect the activation of compensatory mechanisms of cognitive decline in people with neurodegenerative diseases. Here, we investigated whether altered large-scale couplings of brain oscillations could be linked to the balancing of cognitive decline in a longitudinal cohort of people with idiopathic rapid eye-movement sleep behavior disorder (iRBD).

METHODS: We analyzed 18 patients (17 males, 69.7±7.5 years) with iRBD undergoing high-density EEG (HD-EEG), presynaptic dopaminergic imaging, and clinical and neuropsychological assessments at two time points (time interval 24.2±5.9 months). We thus quantified the HD-EEG power distribution, orthogonalized amplitude correlation and weighted phase lag index at both time points and correlated them with clinical, neuropsychological and imaging data.

RESULTS: Four patients phenoconverted at follow-up (three cases of parkinsonism and one of dementia). At the group level, neuropsychological scores decreased over time, without reaching statistical significance. However, alpha phase synchronization increased and delta amplitude correlations decreased significantly at follow-up compared to baseline. Both large-scale network connectivity metrics were significantly correlated with neuropsychological scores but not with sleep quality indices or presynaptic dopaminergic imaging data.

CONCLUSIONS: These results suggest that increased alpha phase synchronization and reduced delta amplitude correlation may be considered electrophysiological signs of an active compensatory mechanism of cognitive impairment in people with iRBD. Large-scale functional modifications may be helpful biomarkers in the characterization of prodromal stages of alpha-synucleinopathies.

PMID:34551110 | DOI:10.1093/sleep/zsab232

Eur J Prev Cardiol. 2021 Sep 20;28(11):1214-1221. doi: 10.1177/2047487320901416.

ABSTRACT

AIMS: Our aim was to evaluate the predictive value of a battery of 10 non-invasive tests of cardiovascular structural and functional health on the future risk of cardiovascular morbid events.

METHODS AND RESULTS: A total of 1900 asymptomatic adults concerned about their risk for cardiovascular disease underwent non-invasive assessment with 10 tests of vascular and cardiac structure and function. A disease score (DS) was calculated for each individual based on these 10 tests. Follow-up (mean 9.2 years) for cardiovascular morbidity and mortality was available for 1442 individuals (mean age 53.2 years, 48.2% women). Those in the lowest DS tertile (0-2) experienced 0.16 cardiovascular events per 100 patient-years (PY), those in the middle tertile (3-5) experienced 0.86 events per 100 PY, and those in the highest tertile (6+) experienced 1.3 events per 100 PY (p < .001). Sensitivity analysis, assuming a neutral effect of DS on projected events in subjects not followed, did not alter statistical significance. Risk assessment using the Framingham risk score (FRS) also predicted morbid events but the two methods differed in identifying individuals at high risk. The net reclassification index was improved by 0.11 (p = 0.01) when DS was added to FRS.

CONCLUSIONS: Assessing the biological disease process in the arteries and heart of asymptomatic adults provides a guide to the risk of a future cardiovascular morbid event. Larger and longer studies are needed to determine whether risk factor algorithms, the severity of the biological process or some combination is the optimal method for identifying individuals in need of intervention to delay morbid events.

PMID:34551082 | DOI:10.1177/2047487320901416

Int J Yoga Therap. 2021 Sep 22. doi: 10.17761/2021-D-20-00060. Online ahead of print.

ABSTRACT

Cricket-bowling performance is known to be influenced by speed of ball release and accuracy. Currently, training sessions typically involve fielding-specific drills and conditioning exercises. Scientific evidence for inclusion of a comprehensive yoga intervention in daily training and exercise sessions remains unexplored. The present study explored the effect of yoga on bowling performance and physical fitness in cricket bowlers. Sports fitness testing and training were conducted among 60 non-elite recreational-club male cricket players aged 13-25 years. Cricket-bowling speed was e valuated using a speed radar gun, accuracy with a test developed by Portus et al., cardiorespiratory endurance using the yo-yo intermittent recovery test, lower-extremity and trunk strength using a back-leg dynamometer, upper-limb power using a medicine ball-throw test, power using a vertical-jump test, and flexibility using a sit-and-reach test. In addition to bowling practice, the yoga intervention group (n = 30) performed pranayama and standing and prone asana, whereas the control group (n = 30) practiced conventional conditioning exercises, for 45 minutes/day, three times a week, for 12 weeks. Improvement in bowling speed, accuracy, cardiorespiratory endurance, muscle strength, and flexibility were comparable between the two groups. Statistically significant improvements in baseline scores in bowling speed, accuracy, cardiorespiratory endurance, muscle flexibility, strength, and power were comparable between the two groups of non-elite male cricket players. Bowling speed improved by 6.52% in the yoga group and by 5.18% in the control group. Bowling accuracy improved by 35.40% in the yoga group and by 31.29% in the control group. Additional research on long-duration intervention in elite players may help to establish the role of yoga in conventional cricket-bowling training.

PMID:34551075 | DOI:10.17761/2021-D-20-00060

J Gastrointestin Liver Dis. 2021 Sep 21;30(3):339-345. doi: 10.15403/jgld-3504.

ABSTRACT

BACKGROUND AND AIMS: Inflammatory bowel diseases (IBD) have been reported to be caused by a complex interplay of immunological, infectious, and genetic factors. Previous studies have suggested that adipokines play a role in IBD by inducing proinflammatory cytokines. We aimed to evaluate the role of visfatin in the diagnosis algorithm of active IBD.

METHODS: 85 newly diagnosed IBD patients [56 diagnosed with ulcerative colitis (UC) and 29 with Crohn’s disease (CD)] and 30 healthy controls were included. IBD phenotypes were described accordingly to Montreal classification. Hemoglobin, total leucocytic count (TLC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), albumin, fecal calprotectin and serum visfatin were measured.

RESULTS: The serum visfatin level was found to be significantly higher in patients with IBD than those in the control group (p<0.001). It was significantly positively correlated with CRP, ESR, and FC in both IBD groups. Receiver operating characteristic curve analysis of visfatin in diagnosis of UC revealed an area under curve of 0.911. At cutoff ≥1.4 ng/ml, the sensitivity was 92.9% and the specificity was 86.7%.. In CD group, at the same cutoff, AUC was 0.974, sensitivity was 96.6% and specificity was 86.7%. There was a statistically significant elevation of serum visfatin in extensive UC (E3) as compared to the other groups. A cutoff ≥3.25 ng/ml revealed 88.9% sensitivity, and 100% specificity in detection of E3 UC. Serum visfatin was significantly increased in CD stricturing phenotype (B2) as compared to non-stricturing non-penetrating CD (B1). A cutoff ≥3.5 ng/ml revealed 83.3% sensitivity, and 100% specificity in detection of B2.

CONCLUSIONS: The serum visfatin level were significantly higher in patients with IBD than in controls. Serum visfatin might be a novel noninvasive marker to detect activity in IBD patients and can be used as predictor of disease extension in patients with UC.

PMID:34551033 | DOI:10.15403/jgld-3504

PLoS One. 2021 Sep 22;16(9):e0257771. doi: 10.1371/journal.pone.0257771. eCollection 2021.

ABSTRACT

OBJECTIVE: Pregnant women satisfaction with the Prevention of Mother-To-Child HIV Transmission services is an essential parameter in the determination of the quality of care and performance. This study aimed to measure the gap between pregnant women expectations of PMTCT services and perceptions of the actual PMTCT services and the relationship between their service gap scores and socio-demographic characteristics.

METHODS: A cross-sectional descriptive study design was conducted from August to September 2020 on a sample of 105 participants. A pre-tested SERVIQUAL questionnaire was used to collect data and paired sample t-test, independent one-sample t-test, and one-way ANOVA was used to compare mean service gap scores. A p-value of < 0.05 was considered statistically significant.

RESULTS: The overall mean gap score was (+ 0.31) indicating pregnant women perceived value of the quality of care of PMTCT services. The gap score in the 5 service dimensions was as follows: empathy (+0.49), tangibles (+0.43), assurance (+0.22), responsiveness (+0.20), and reliability (+0.19). Marital status (p-value 0.031) was the only social demographic characteristic associated with pregnant women service gap scores.

CONCLUSION: Overall, pregnant women perceptions of PMTCT services provided in the RCH clinic at KCMC were meet. Marital status was associated with the overall pregnant women service gap scores and perceived quality of care with PMTCT services. Pregnant women who were married had small service gap scores compared to either divorced or widowed or cohabiting women.

PMID:34551008 | DOI:10.1371/journal.pone.0257771

PLoS One. 2021 Sep 22;16(9):e0257604. doi: 10.1371/journal.pone.0257604. eCollection 2021.

ABSTRACT

BACKGROUND: Patients with COVID-19 are follow-up in primary care and long COVID is scarcely defined. The study aim was to describe SARS-CoV-2 pneumonia and cut-offs for defining long COVID in primary care follow-up patients.

METHODS: A retrospective observational study in primary care in Madrid, Spain, was conducted. Data was collected during 6 months (April to September) in 2020, during COVID-19 first wave, from patients ≥ 18 years with SARS-CoV-2 pneumonia diagnosed. Variables: sociodemographic, comorbidities, COVID-19 symptoms and complications, laboratory test and chest X-ray. Descriptive statistics were used, mean (standard deviation (SD)) and medians (interquartile range (IQR)) respectively. Differences were detected applying X2 test, Student’s T-test, ANOVA, Wilcoxon-Mann-Whitney or Kruskal-Wallis depending on variable characteristics.

RESULTS: 155 patients presented pneumonia in day 7.8 from the onset (79.4% were hospitalized, median length of 7.0 days (IQR: 3.0, 13.0)). After discharge, the follow-up lasted 54.0 median days (IQR 42.0, 88.0) and 12.2 mean (SD 6.4) phone calls were registered per patient. The main symptoms and their duration were: cough (41.9%, 12 days), dyspnoea (31.0%, 15 days), asthenia (26.5%, 21 days). Different cut-off points were applied for long COVID and week 4 was considered the best milestone (28.3% of the sample still had symptoms after week 4) versus week 12 (8.3%). Patients who still had symptoms >4 weeks follow-up took place over 81.0 days (IQR: 50.5, 103.0), their symptoms were more prevalent and lasted longer than those ≤ 4 weeks: cough (63.6% 30 days), dyspnoea (54.6%, 46 days), and asthenia (56.8%, 29 days). Embolism was more frequent in patients who still had symptoms >4 weeks than those with symptoms ≤4 weeks (9.1% vs 1.8%, p value 0.034).

CONCLUSION: Most patients with SARS-CoV-2 pneumonia recovered during the first 4 weeks from the beginning of the infection. The cut-off point to define long COVID, as persisting symptoms, should be between 4 to 12 weeks from the onset of the symptoms.

PMID:34551007 | DOI:10.1371/journal.pone.0257604

PLoS One. 2021 Sep 22;16(9):e0257617. doi: 10.1371/journal.pone.0257617. eCollection 2021.

ABSTRACT

BACKGROUND: Hypertension and its consequent end-organ damage including Hypertensive Heart Disease (HHD) are a major concern that impact health, resulting into impairment and reduced quality of life (QOL). The purpose of this study was to describe the burden of HHD in Iran and comparing it with the World Bank upper middle-income countries (UMICs) in terms of disability-adjusted life years (DALY), mortality and prevalence.

METHODS: Using data from the Global Burden of Disease study 2017, we compared the number of DALYs, deaths and prevalence trends for HHD from 1990 to 2017 in all age groups for both sex in Iran, and compared the epidemiology and trends with UMICs and globally.

RESULTS: The age-standardized DALY rate for HHD increased by 51.6% for men (95% uncertainty interval [UI] 305.8 to 436.7 per 100,000) and 4.4% for women (95% UI 429.4 to 448.7 per 100,000) in Iran. The age-standardized prevalence of HHD in Iran was almost twice times higher than globally and 1.5-times more than the World Bank UMICs. The age-standardized death rate for HDD increased by 60.1% (95% UI 17.3 to 27.7% per 100,000) for men and by 21.7% (95% UI 25.85 to 31.48 per 100,000) for women from 1990 to 2017. Age-standardized death rate in Iran was 2.4 and 1.9 times higher than globally and UMICs, respectively.

CONCLUSIONS: The higher prevalence and death rate in Iran in comparison with UMICs and globally should encourage health care provider to perform intensive screening activities in at risk population to prevent HHD and mitigate its mortality.

PMID:34551003 | DOI:10.1371/journal.pone.0257617

PLoS One. 2021 Sep 22;16(9):e0256889. doi: 10.1371/journal.pone.0256889. eCollection 2021.

ABSTRACT

Vaccinating individuals with more exposure to others can be disproportionately effective, in theory, but identifying these individuals is difficult and has long prevented implementation of such strategies. Here, we propose how the technology underlying digital contact tracing could be harnessed to boost vaccine coverage among these individuals. In order to assess the impact of this “hot-spotting” proposal we model the spread of disease using percolation theory, a collection of analytical techniques from statistical physics. Furthermore, we introduce a novel measure which we call the efficiency, defined as the percentage decrease in the reproduction number per percentage of the population vaccinated. We find that optimal implementations of the proposal can achieve herd immunity with as little as half as many vaccine doses as a non-targeted strategy, and is attractive even for relatively low rates of app usage.

PMID:34551000 | DOI:10.1371/journal.pone.0256889