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Nevin Manimala Statistics

Design and methods for understanding the state of cystic fibrosis care amid the COVID-19 pandemic

J Cyst Fibros. 2021 Dec;20 Suppl 3:3-8. doi: 10.1016/j.jcf.2021.08.028.

ABSTRACT

BACKGROUND: Novel therapies have dramatically changed cystic fibrosis (CF) and innovative care delivery systems are needed to meet future patient needs. Telehealth has been shown to be an efficient and desirable form of care delivery. The COVID-19 pandemic caused a rapid shift to telehealth, and this presented a unique opportunity to study facilitators, barriers, and satisfaction with this mode of care delivery. We aim to report survey methods, demographics and telehealth use among CF care programs, patients, and families during the pandemic.

METHODS: CF programs completed two surveys between July 29 and September 18, 2020, and between April 19 and May 19, 2021. Patients and families completed a similar survey between August 31 and October 30, 2020. The surveys addressed topics assessing the pandemic’s financial impact, telehealth modes and experiences, licensure and reimbursement issues, health screening, and remote monitoring. Quantitative data were analyzed with descriptive statistics and were compared to the CF Foundation Patient Registry.

RESULTS: Most programs (278 at timepoint one and 274 at timepoint two) provided telehealth during the pandemic. The percent of visits containing either telephone or video components changed from 45% to 25% over the time periods. Additionally, 424 patients and families from various ages and backgrounds responded to the survey and 81% reported having a telehealth visit.

CONCLUSIONS: The pandemic accelerated telehealth adoption and these datasets are a valuable source for exploring telehealth barriers and facilitators, the quality-of-care experience, financial and workforce implications, the impact on underrepresented populations, and implications for coverage and reimbursement.

PMID:34930539 | DOI:10.1016/j.jcf.2021.08.028

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Nevin Manimala Statistics

Functional outcome of 103 fractures of the proximal fifth metatarsal bone

Eur J Med Res. 2021 Dec 20;26(1):150. doi: 10.1186/s40001-021-00623-6.

ABSTRACT

BACKGROUND: Metatarsal fractures are common skeletal injuries of the lower extremity in adults. The majority involves the proximal fifth metatarsal bone. In the current literature, there still exists controversy regarding treatment recommendations for the different fracture entities.

METHODS: All patients suffering from single fractures to the proximal fifth metatarsal bone between 2003 and 2015 were enrolled in this retrospective analysis. Only patients with a minimum follow-up of 12 months were included. The fractures were classified according to Lawrence and Botte (L&B). Data were collected via patient registry, radiographs and a standardized questionnaire (Foot and Ankle Outcome Score = FOAS). For outcome analysis, the nonparametric Mann-Whitney U test was performed and Spearman’s rank correlation coefficient calculated.

RESULTS: In total, the functional outcomes of 103 patients suffering from fractures to the proximal fifth metatarsal bone were analyzed. L&B type I fractures (n = 13) had a FAOS score of 91 ± 23, L&B type II (n = 67) presented a score of 91 ± 15 and L&B type III (n = 23) a score of 93 ± 11. Surgically treated patients with an L&B type II fracture had no statistically significant better functional outcome in comparison to conservative management (p = 0.89). Operatively treated L&B type III fractures tended to have a better functional score (p = 0.16). The follow-up time was 58 (min: 15; max: 164) months.

CONCLUSIONS: Overall, the functional outcome following fractures to the proximal fifth metatarsal bone is satisfactory. Conservatively treated L&B type II fractures showed an equivalent functional outcome compared to surgical management. Patients with an L&B type III fracture mainly were treated surgically, but difference in FAOS score did not reach level of significance.

PMID:34930495 | DOI:10.1186/s40001-021-00623-6

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Nevin Manimala Statistics

Observational case series: six neurosurgical patients with septic shock demonstrating clinical improvement after a combination of standard care and blood purification

Eur J Med Res. 2021 Dec 20;26(1):151. doi: 10.1186/s40001-021-00614-7.

ABSTRACT

BACKGROUND: For patients with primary brain injury, septic shock is especially dangerous due to the possibility of secondary cerebral damage. The key factor of sepsis-associated brain injury is inflammatory mediators, pathogen and damage-associated molecular patterns (PAMPs, DAMPs) release. Theoretically, blood purification may be beneficial for patients with primary brain injury due to its possibility for fast removal of inflammatory mediators.

CASE PRESENTATION: We report on six post-neurosurgery septic shock patients treated with combined blood purification (CBP), which included CRRT with high adsorption capacity membrane in combination with CytoSorb adsorber. Clinical improvement in the course of CBP was registered in all patients. Three patients had a stable clinical improvement; the other three patients had only a transient improvement due to underlying neurological and cardiac deficits aggravation. We observed septic shock reversal in four patients. The key observations of the case series are a significant decrease in MOF severity (measured by SOFA score) and in catecholamine need (not statistically significant). By the end of CBP we observed a significant decrease in blood lactate, PCT and IL-6 levels. Two patients demonstrated level of consciousness increase in the setting of CBP therapy measured by GCS and FOUR score.

CONCLUSION: This case series demonstrates that CBP therapy may have a role for septic shock patients with primary brain injury.

PMID:34930484 | DOI:10.1186/s40001-021-00614-7

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Nevin Manimala Statistics

Impact of zinc oxide, benzoic acid and probiotics on the performance and cecal microbiota of piglets

Anim Microbiome. 2021 Dec 20;3(1):86. doi: 10.1186/s42523-021-00151-y.

ABSTRACT

BACKGROUND: Intestinal health remains a key factor in animal production because it is essential for digestion, absorption and bacterial fermentation. Feed additives have been used to attenuate the weaning stress such as Zinc Oxide (ZnO) and benzoic acid (C7H6O2). The objective of this study was to evaluate the impact of of benzoic acid and probiotics (BA + P) on performance, diarrhea and cecal microbiota of piglets in the nursery phase (23 to 65 days).

RESULTS: One hundred and sixty weaned piglets with an initial weight of 6.335 ± 0.698 kg and 23 days of age were submitted to four treatments: supplementation with 2500 ppm of Zinc oxide (ZnO), supplementation with a commercial blend of benzoic acid and probiotics (Bacillus licheniformis, Bacillus subtilis and Enterococcus faecium NCIMB 10415; Vevogut P®) (BA + P), supplementation with Zinc oxide plus benzoic acid and probiotics (ZnO + BA + P), and controls receiving only the basal diet without any supplementation. At 65 days of age, 32 piglets (n = 8 per treatment) were slaughtered for the evaluation of the cecal microbiota. Supplementation with ZnO and BA + P were associated with better feed conversion (P < 0.05) in the early stage (23 to 49 days) and with an improvement in all performance parameters over the entire experimental period. The occurrence of diarrhea was lower (P < 0.05) in the BA + P group. The 4 most abundant phyla along with unclassified bacteria represented 93% of all sequences. Firmicutes dominated the cecal microbiota of all groups, followed by Bacteroidetes. Richness represented by the observed number of genera and by the Chao index were statistically lower in ZnO and ZnO + BA + P supplemented animals compared to controls. The beta diversity analysis that compares similarities between bacterial communities demonstrated formation of two distinct clusters containing samples with and without supplementation with ZnO, confirming a strong influence of ZnO on the intestinal microbiota.

CONCLUSION: The use of Benzoic acid with probiotics yields similar performance results with lower impact on the gut microbiota compared to ZnO, and it should be considered as a potential alternative in swine production.

PMID:34930490 | DOI:10.1186/s42523-021-00151-y

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Testing a breast cancer prevention and a multiple disease prevention weight loss programme amongst women within the UK NHS breast screening programme-a randomised feasibility study

Pilot Feasibility Stud. 2021 Dec 20;7(1):220. doi: 10.1186/s40814-021-00947-4.

ABSTRACT

BACKGROUND: Excess weight and unhealthy behaviours (e.g. sedentariness, high alcohol) are common amongst women including those attending breast screening. These factors increase the risk of breast cancer and other diseases. We tested the feasibility and acceptability of a weight loss/behaviour change programme framed to reduce breast cancer risk (breast cancer prevention programme, BCPP) compared to one framed to reduce risk of breast cancer, cardiovascular disease (CVD) and diabetes (T2D) (multiple disease prevention programme, MDPP).

METHODS: Women aged 47-73 years with overweight or obesity (n = 1356) in the NHS Breast Screening Programme (NHSBSP) were randomised (1:2) to be invited to join a BCPP or a MDPP. The BCPP included personalised information on breast cancer risk and a web and phone weight loss/behaviour change intervention. The MDPP also included an NHS Health Check (lipids, blood pressure, HbA1c and personalised feedback for risk of CVD [QRISK2] and T2D [QDiabetes and HbA1c]). Primary outcomes were uptake and retention and other feasibility outcomes which include intervention fidelity and prevalence of high CVD and T2D risk. Secondary outcomes included change in weight.

RESULTS: The BCPP and MDPP had comparable rates of uptake: 45/508 (9%) vs. 81/848 (10%) and 12-month retention; 33/45 (73%) vs. 53/81 (65%). Both programmes had a high fidelity of delivery with receipt of mean (95% CI) 90 (88-98% of scheduled calls, 91 (86-95%) of scheduled e-mails and 89 (76-102) website entries per woman over the 12-month period. The MDPP identified 15% of women with a previously unknown 10-year CVD QRISK2 of ≥ 10% and 56% with 10-year Qdiabetes risk of ≥ 10%. Both groups experienced good comparable weight loss: BCPP 26/45 (58%) and MDPP 46/81 (57%) with greater than 5% weight loss at 12 months using baseline observation carried forward imputation.

CONCLUSIONS: Both programmes appeared feasible. The MDPP identified previously unknown CVD and T2D risk factors but does not appear to increase engagement with behaviour change beyond a standard BCPP amongst women attending breast screening. A future definitive effectiveness trial of BCPP is supported by acceptable uptake and retention, and good weight loss.

TRIAL REGISTRATION: ISRCTN91372184 , registered 28 September 2014.

PMID:34930478 | DOI:10.1186/s40814-021-00947-4

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Nevin Manimala Statistics

Intensive care unit versus high-dependency care unit for patients with acute heart failure: a nationwide propensity score-matched cohort study

J Intensive Care. 2021 Dec 20;9(1):78. doi: 10.1186/s40560-021-00592-2.

ABSTRACT

BACKGROUND: A structure and staffing model similar to that in general intensive care unit (ICUs) is applied to cardiac intensive care unit (CICUs) for patients with acute heart failure. However, there is limited evidence on the structure and staffing model of CICUs. The present study aimed to assess whether critical care for patients with acute heart failure in the ICUs is associated with improved outcomes than care in the high-dependency care units (HDUs), the hospital units in which patient care levels and costs are between the levels found in the ICU and general ward.

METHODS: This nationwide, propensity score-matched, retrospective cohort study was performed using a national administrative inpatient database in Japan. We identified all patients who were hospitalized for acute heart failure and admitted to the ICU or HDU on the day of hospital admission from April 2014 to March 2019. Propensity score-matching analysis was performed to compare the in-hospital mortality between acute heart failure patients treated in the ICU and HDU on the day of hospital admission.

RESULTS: Of 202,866 eligible patients, 78,646 (39%) and 124,220 (61%) were admitted to the ICU and HDU, respectively, on the day of admission. After propensity score matching, there was no statistically significant difference in in-hospital mortality between patients who were admitted to the ICU and HDU on the day of admission (10.7% vs. 11.4%; difference, – 0.6%; 95% confidence interval, – 1.5% to 0.2%). In the subgroup analyses, there was a statistically significant difference in in-hospital mortality between the ICU and HDU groups among patients receiving noninvasive ventilation (9.4% vs. 10.5%; difference, – 1.0%; 95% confidence interval, – 1.9% to – 0.1%) and patients receiving intubation (32.5% vs. 40.6%; difference, – 8.0%; 95% confidence interval, – 14.5% to – 1.5%). There were no statistically significant differences in other subgroup analyses.

CONCLUSIONS: Critical care in ICUs was not associated with lower in-hospital mortality than critical care in HDUs among patients with acute heart failure. However, critical care in ICUs was associated with lower in-hospital mortality than critical care in HDUs among patients receiving noninvasive ventilation and intubation.

PMID:34930470 | DOI:10.1186/s40560-021-00592-2

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Nevin Manimala Statistics

Data on the Facebook marketing strategies used by fast-food chains in four Latin American countries during the COVID-19 lockdowns

BMC Res Notes. 2021 Dec 20;14(1):463. doi: 10.1186/s13104-021-05870-8.

ABSTRACT

OBJECTIVES: During the COVID-19 pandemic, most countries implemented lockdowns that motivated changes in the dietary patterns, physical activity, and body mass index (BMI) of consumers worldwide, as well as the emergence of new food marketing strategies in social media. We sought to design and validate a methodology for monitoring and evaluating the Facebook marketing strategies of multinational fast-food chains in response to the COVID-19 pandemic.

DATA DESCRIPTION: We developed three datasets. First, a dataset with the Uniform Resource Locators (URLs) of 1015 Facebook posts of five fast-food chains present in Argentina, Bolivia, Guatemala, and Peru. Second, a dataset of 106 content-analyzed posts we used in a pilot to determine intercoder reliability using statistical tests. Third, a dataset of a final sample of the 1015 content-analyzed posts that we used to determine the variables most frequently used. Following a mixed-methods approach, we developed 29 variables that recorded general information, as well as the marketing strategies we identified in the posts, including 14 COVID-19 specific variables. These data should help to monitor the social media marketing strategies that fast-food chains have introduced during the COVID-19 lockdowns, thus providing initial evidence about how they could be contributing to an unhealthy food environment.

PMID:34930460 | DOI:10.1186/s13104-021-05870-8

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Motor vehicle crashes on tribal reservations: mapping and statistics

Inj Epidemiol. 2021 Dec 20;8(Suppl 2):71. doi: 10.1186/s40621-021-00361-7.

ABSTRACT

BACKGROUND: Motor vehicle crashes (MVC’s) in the American Indian/Alaska Native (AI/AN) communities account for 43% of unintentional injury deaths. This article introduces MVC data and geographic information system (GIS) mapping for tribal reservations.

METHODS: Utilizing a sample of Montana Department of Transportation (DOT) data for the Flathead reservations to calculate frequencies and proportions of crash types (i.e., property damage or no-injury, injury, fatality or unknown), while also mapping these data to provide a cross-sectional snapshot of MVC’s.

RESULTS: Overall, 515 MVC’s occurred for years 2016 through 2018, with no-injury, injury, and fatality accounting for 72.2%, 24.9% and 1.8% of all crashes, respectively, with the number of MVC’s ranging up to 30 per square mile.

CONCLUSION: Examining DOT data and utilizing it for visual representation of MVC’s can be used as an additional source in uncovering patterns and trends on Tribal reservations and supporting MVC prevention efforts.

PMID:34930461 | DOI:10.1186/s40621-021-00361-7

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Impact of potential modifications to Alzheimer’s disease clinical trials in response to disruption by COVID-19: a simulation study

Alzheimers Res Ther. 2021 Dec 20;13(1):201. doi: 10.1186/s13195-021-00938-w.

ABSTRACT

BACKGROUND: The COVID-19 pandemic disrupted Alzheimer disease randomized clinical trials (RCTs), forcing investigators to make changes in the conduct of such trials while endeavoring to maintain their validity. Changing ongoing RCTs carries risks for biases and threats to validity. To understand the impact of exigent modifications due to COVID-19, we examined several scenarios in symptomatic and disease modification trials that could be made.

METHODS: We identified both symptomatic and disease modification Alzheimer disease RCTs as exemplars of those that would be affected by the pandemic and considered the types of changes that sponsors could make to each. We modeled three scenarios for each of the types of trials using existing datasets, adjusting enrollment, follow-ups, and dropouts to examine the potential effects COVID-19-related changes. Simulations were performed that accounted for completion and dropout patterns using linear mixed effects models, modeling time as continuous and categorical. The statistical power of the scenarios was determined.

RESULTS: Truncating both symptomatic and disease modification trials led to underpowered trials. By contrast, adapting the trials by extending the treatment period, temporarily stopping treatment, delaying outcomes assessments, and performing remote assessment allowed for increased statistical power nearly to the level originally planned.

DISCUSSION: These analyses support the idea that disrupted trials under common scenarios are better continued and extended even in the face of dropouts, treatment disruptions, missing outcomes, and other exigencies and that adaptations can be made that maintain the trials’ validity. We suggest some adaptive methods to do this noting that some changes become under-powered to detect the original effect sizes and expected outcomes. These analyses provide insight to better plan trials that are resilient to unexpected changes to the medical, social, and political milieu.

PMID:34930444 | DOI:10.1186/s13195-021-00938-w

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Nevin Manimala Statistics

The Metaproteomics Initiative: a coordinated approach for propelling the functional characterization of microbiomes

Microbiome. 2021 Dec 20;9(1):243. doi: 10.1186/s40168-021-01176-w.

ABSTRACT

Through connecting genomic and metabolic information, metaproteomics is an essential approach for understanding how microbiomes function in space and time. The international metaproteomics community is delighted to announce the launch of the Metaproteomics Initiative (www.metaproteomics.org), the goal of which is to promote dissemination of metaproteomics fundamentals, advancements, and applications through collaborative networking in microbiome research. The Initiative aims to be the central information hub and open meeting place where newcomers and experts interact to communicate, standardize, and accelerate experimental and bioinformatic methodologies in this field. We invite the entire microbiome community to join and discuss potential synergies at the interfaces with other disciplines, and to collectively promote innovative approaches to gain deeper insights into microbiome functions and dynamics. Video Abstract.

PMID:34930457 | DOI:10.1186/s40168-021-01176-w