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Nevin Manimala Statistics

Comparison of novel machine vision spinal image guidance system with existing 3D fluoroscopy-based navigation system: a randomized prospective study

Spine J. 2021 Oct 16:S1529-9430(21)00952-9. doi: 10.1016/j.spinee.2021.10.002. Online ahead of print.

ABSTRACT

BACKGROUND CONTEXT: The use of spinal image guidance systems (IGS) has increased patient safety, accuracy, operative efficiency, and reduced revision rates in pedicle screw placement procedures. Traditional intraoperative 3D fluoroscopy or CT imaging produces potentially harmful ionizing radiation and increases operative time to register the patient. An IGS, FLASH Navigation, uses machine vision through high resolution stereoscopic cameras and structured visible light to build a 3D topographical map of the patient’s bony surface anatomy enabling navigation use without ionizing radiation.

PURPOSE: We aimed to compare FLASH navigation system to a widely used 3D fluoroscopic navigation (3D) platform by comparing radiation exposure and pedicle screw accuracy.

DESIGN: A randomized prospective comparative cohort study of consecutive patients undergoing open posterior lumbar instrumented fusion.

PATIENT SAMPLE: Adults diagnosed with spinal pathology requiring surgical treatment and planning for open posterior lumbar fusion with pedicle screws implanted into 1-4 vertebral levels.

OUTCOME MEASURES: Outcome measures included mean intraoperative fluoroscopy time and dose, mean CT dose length product (DLP) for preoperative and day 2 CT, pedicle screw accuracy by CT, estimated blood loss and revision surgery rate.

METHODS: Consecutive patients were randomized 1:1 to FLASH or 3D and underwent posterior lumbar instrumented fusion. Radiation doses were recorded from pre- and postoperative CT and intraoperative 3D fluoroscopy. Two independent blinded radiologists reviewed pedicle screw accuracy on CT.

RESULTS: A total of 429 (n=210 FLASH, n=219 3D) pedicle screws were placed in 90 patients (n=45 FLASH, n=45 3D) over the 18-month study period. Mean age and indication for surgery were similar between both groups, with a non-significantly higher ratio of males in the 3D group. Mean intraoperative fluoroscopy time and doses were significantly reduced in FLASH compared to 3D (4.51±3.71s vs 79.6±23.0s, p<0.001 and 80.9±68.1cGycm2 vs 3704.1±3442.4 cGycm2, p<0.001, respectively). This represented a relative reduction of 94.3% in the total intraoperative radiation time and a 97.8% reduction in the total intraoperative radiation dose. Mean preoperative CT DLP and mean day 2 postoperative CT DLP were significantly reduced in FLASH compared to 3D (662.0±440.4mGy-cm vs 1008.9±616.3 mGy-cm, p<0.001 and 577.9±294.3 mGy-cm vs 980.7±441.6 mGy-cm, p<0.001, respectively). This represented relative reductions of 34.4% and 41.0% in the preoperative CT dose and postoperative total DLP, respectively. The FLASH group required an average of 1.2 registrations in each case with an average of 2447 (±961.3) data points registered with a mean registration time of 106s (±52.1). A rapid re-registration mechanism was utilized in 22% (n=10/45) of cases and took 22.7s (±11.3). Re-registration was used in 7% (n=3/45) in the 3D group. Pedicle screw accuracy was high in FLASH (98.1%) and 3D (97.3%) groups with no pedicle breach >2mm in either group (p<0.001). EBL was not statistically different between the groups (p=0.38). No neurovascular injuries occurred, and no patients required return to theatre for screw repositioning.

CONCLUSIONS: FLASH and 3D IGS demonstrate high accuracy for pedicle screw placement. FLASH showed significant reduction in intraoperative radiation time and dose with lower but non-significant blood loss. FLASH showed significant reduction in preoperative and postoperative radiation, but this may be associated to the lower number of males/females preponderance in this group. FLASH provides similar accuracy to contemporary IGS without requiring 3D-fluoroscopy or radiolucent operating tables. Reducing registration time and specialized equipment may reduce costs.

PMID:34666179 | DOI:10.1016/j.spinee.2021.10.002

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Mid-Term Outcomes of Chimney Endovascular Aortic Aneurysm Repair: A Systematic Review and Meta-analysis

Ann Vasc Surg. 2021 Oct 16:S0890-5096(21)00710-X. doi: 10.1016/j.avsg.2021.08.013. Online ahead of print.

ABSTRACT

OBJECTIVE: To provide an overview of the literature on the mid-term outcomes of chimney EVAR (ChEVAR) for the treatment of juxtarenal abdominal aortic aneurysms (JAAA).

METHODS: Different electronic databases were searched for published articles up to January 2020. The eligibility criteria were studies describing mid- or long-term outcomes of chimney EVAR (mean follow-up at least 1 year) for treatment of JAAA, including more than 10 cases, published in English, and with full text available. The outcomes measure were overall survival rate, target vessel patency, and freedom from reintervention at 3 years. Quality of the included studies was analysed using the MINORS criteria. Pooled effect estimates were analysed using random-effect models and heterogeneity was tested using I2 statistics.

RESULTS: Thirteen articles met the inclusion criteria. The included studies described 1,019 patients. According to the quality assessment, methodological quality was moderate to poor. The pooled overall survival, freedom from reintervention, and target vessel patency at 3 year was 81.4 % (95%CI 73.8 to 87.9), 85.7% (95%CI 75.6 to 93.5), and 95.1% (95%CI 89.3 to 98.7) respectively.

CONCLUSION: The results of this review show good to acceptable short and mid-term survival and good mid-term durability, which supports that ChEVAR as a suitable alternative in high-risk JAAA. However, proper patient selection for ChEVAR seems essential to attain good mid-term outcomes, and further large prospective and good quality studies are required to demonstrate its long-term results and enable conclusions on specific determinants for outcome.

PMID:34666145 | DOI:10.1016/j.avsg.2021.08.013

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Рrediction of the outcome of pregnancy in women with reccurent miscarriage

Klin Lab Diagn. 2021 Oct 18;66(10):618-622. doi: 10.51620/0869-2084-2021-66-10-618-622.

ABSTRACT

To determine the relative content of monocytes in the peripheral blood producing IL-4, IL-6, IL-10, IFNγ, to identify new criteria for predicting abortion before 22 weeks of gestation in women with the threat of early termination and recurrent miscarriage. Materials and methods. A survey of 91 women in the gestation period of 5-12 weeks was carried out. The main group consisted of 59 women with recurrent miscarriage and the threat of early termination at the time of the study. Depending on the outcome of pregnancy, the main group was subdivided into 3 subgroups: subgroup I – 44 women whose pregnancy ended in timely delivery, II – 8 women who had preterm labor, III – 8 women with termination of pregnancy up to 22 weeks ( missed pregnancy or spontaneous miscarriage). The control group consisted of 32 women with uncomplicated pregnancy. The relative content of IL-4 +, IL-6 +, IL-10 +, IFNγ + monocytes was determined by flow cytometry on FACSCanto II (Becton Dickinson, USA). In women with threatened early miscarriage and recurrent miscarriage, the percentage of IL-4 + and IL-10 + cells in the population of peripheral monocytes is significantly lower, while IL-6 + cells are higher compared to the control group (p = 0.0001 in in all cases), no statistically significant differences were found in the percentage of IFNγ + cells (p = 0.076). A retrospective analysis revealed that in the group of women with termination of pregnancy up to 22 weeks, there was a significant decrease in IL-10 + monocytes in the peripheral venous blood. Prediction of termination of pregnancy before 22 weeks of gestation is possible with a relative content of IL-10 + monocytes equal to 27.0% or less (sensitivity 87.5%, specificity 95.2%, accuracy 93.1%).

PMID:34665948 | DOI:10.51620/0869-2084-2021-66-10-618-622

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Nevin Manimala Statistics

Graduate training during the COVID-19 pandemic: North American genetic counseling students’ challenges, intolerance of uncertainty, and psychological well-being

J Genet Couns. 2021 Oct 19. doi: 10.1002/jgc4.1501. Online ahead of print.

ABSTRACT

The COVID-19 pandemic has upended genetic counseling (GC) graduate students’ lives, as they have been forced to transition, manage, and acclimate to life during a pandemic. The current study is a first step in understanding their lived experiences during this historic, global event. We investigated academic and personal challenges, intolerance of uncertainty, and psychological well-being of GC students (n = 248) who trained during the pandemic (GC-COV cohort) and those who did not (GC-NoCOV cohort). Participants completed an online survey (July-September 2020) that used validated measures of Intolerance of Uncertainty and Psychological Well-Being. To assess the academic and personal challenges students experienced during GC graduate training, we developed a 43-item measure. Principal axis factoring of the items revealed categories of challenges related to the following: Academic & Professional Development, Self-Regulation & Resilience, Institutional & Program Leadership, and Financial Stability. There was no cohort difference in Psychological Well-Being. Linear mixed-effects modeling showed significant cohort differences in challenges. Multiple linear regression analyses revealed that the GC-COV cohort’s Psychological Well-Being was statistically significantly predicted by Institutional & Program Leadership challenges (p = .029), Self-Regulation & Resilience challenges (p = .013), and Intolerance of Uncertainty (p = .010). For the GC-NoCOV cohort, the statistically significant predictor of Psychological Well-Being was Self-Regulation & Resilience challenges (p = .029). Our findings demonstrate that GC students training during the COVID-19 pandemic have experienced various personal, academic, and psychological disruptions and highlight a need to develop resources and implement interventions supporting students’ academic development and psychological well-being.

PMID:34665887 | DOI:10.1002/jgc4.1501

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Clinical outcomes of all-ceramic single crowns and fixed dental prostheses supported by ceramic implants: A systematic review and meta-analyses

Clin Oral Implants Res. 2021 Oct 19. doi: 10.1111/clr.13871. Online ahead of print.

ABSTRACT

OBJECTIVE: To analyze the clinical outcomes of all-ceramic single crowns (SCs) and fixed-dental-prostheses (FDPs) supported by ceramic implants.

MATERIALS AND METHODS: Based on a focused question and customized PICO-framework, electronic (Medline/EMBASE/Cochrane) and manual searches for studies reporting the clinical outcomes of all-ceramic SCs and FDPs supported by ceramic implants ≥ 12 months were performed. The primary outcomes were reconstruction survival as well as the chipping proportion. The secondary outcomes were implant survival, technical complications and patient-related-outcome-measurements. Meta-analyses were performed after 1, 2, and 5 years using random-effect meta-analyses.

RESULTS: Eight of the 1403 initially screened titles and 55 full-texts were included. Five reported on monolithic lithium-disilicate (LS2) SCs, one on veneered zirconia SCs, and two on veneered zirconia SCs and FDPs, which reported all on cement-retained reconstructions (mean observation: 12.0-61.0 months). Meta-analyses estimated a 5-year survival rate of 94% (95% confidence interval [CI]: 82%-100%) for overall implant survival. Reconstruction survival proportions after 5 years were: monolithic LS2, 100% (95%CI: 95%-100%); veneered zirconia SCs, 89% (95%CI: 62%-100%); and veneered zirconia FDPs 94% (95%CI: 81%-100%). The chipping proportion after 5 years was: monolithic LS2, 2% (95%CI: 0%-11%); veneered zirconia SCs, 38% (95%CI: 24%-54%); and veneered zirconia FDPs, 57% (95%CI: 38%-76%). Further outcomes were summarized descriptively.

CONCLUSIONS: Due to the limited data available, only tendencies could be identified. All-ceramic reconstructions supported by ceramic implants demonstrated promising survival rates after mid-term observation. However, high chipping proportions of veneered zirconia SCs and, particularly, FDPs diminished the overall outcome. Monolithic LS2 demonstrated fewer clinical complications. Monolithic reconstructions could be a valid treatment option for ceramic implants.

PMID:34665900 | DOI:10.1111/clr.13871

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Effectiveness of lumbar support with built-in massager system on spinal angle profiles among high-powered traffic police motorcycle riders: A randomised controlled trial

PLoS One. 2021 Oct 19;16(10):e0258796. doi: 10.1371/journal.pone.0258796. eCollection 2021.

ABSTRACT

Traffic police riders are exposed to prolonged static postures causing significant angular deviation of the musculoskeletal, including the lumbar angle (L1-L5). This postural alteration contributes to awkward posture, musculoskeletal disorders and spinal injury, especially in the lower back area, as it is one of the most severe modern diseases nowadays. Thus, the study aimed to evaluate the effect of lumbar support with a built-in massager system on spinal angle profiles among traffic police riders. A randomised controlled trial (pre-testpost-test control design) was used to assess spinal angle pattern while riding the high-powered motorcycle for 20 minutes. Twenty-four traffic police riders were randomly selected to participate and 12 riders were assigned to the control group and 12 riders to the experimental group. The pre-test and post-test were conducted at a one-week interval. Each participant was required to wear a TruPosture Smart Shirt (to monitor spinal posture). The TruPosture Apps recorded the spinal angle pattern. The data indicated that the police riders using motorcycle seat with lumbar support and built-in massager system showed a huge improvement in maintaining posture which only involves slight spinal angle deviation changes from the spinal reference angle throughout the 20 minutes ride. The data collected then were analysed using the Mann-Whitney test and Wilcoxon signed-ranked test to verify a statistically significant difference between and within the control and experimental groups. There were significant differences in all sensors between the control group and experimental groups (p<0.05) and within the experimental group. According to the findings, it can be said that the ergonomic intervention prototype (lumbar support with built-in massager system) successfully helps to maintain and improve the natural curve of the spinal posture. This indirectly would reduce the risk of developing musculoskeletal disorders and spinal injury among traffic police riders.

PMID:34665845 | DOI:10.1371/journal.pone.0258796

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COVID-19 mortality across occupations and secondary risks for elderly individuals in the household: A population register-based study

Scand J Work Environ Health. 2021 Oct 19:3992. doi: 10.5271/sjweh.3992. Online ahead of print.

ABSTRACT

Objectives This is the first population-level study to examine inequalities in COVID-19 mortality according to working-age individuals’ occupations and the indirect occupational effects on COVID-19 mortality of older individuals who live with them. Methods We used early-release data for the entire population of Sweden of all recorded COVID-19 deaths from 12 March 2020 to 23 February 2021, which we linked to administrative registers and occupational measures. Cox proportional hazard models assessed relative risks of COVID-19 mortality for the working-aged population registered in an occupation in December 2018 and the older population who lived with them. Results Among working aged-adults, taxi/bus drivers had the highest relative risk of COVID-19 mortality: over four times that of skilled workers in IT, economics, or administration when adjusted only for basic demographic characteristics. After adjusting for socioeconomic factors (education, income and country of birth), there are no occupational groups with clearly elevated (statistically significant) COVID-19 mortality. Neither a measure of exposure within occupations nor the share that generally can work from home were related to working-aged adults’ risk of COVID-19 mortality. Instead of occupational factors, traditional socioeconomic risk factors best explained variation in COVID-19 mortality. Elderly individuals, however, faced higher COVID-19 mortality risk both when living with a delivery or postal worker or worker(s) in occupations that generally work from home less, even when their socioeconomic factors are taken into account. Conclusions Inequalities in COVID-19 mortality of working-aged adults were mostly based on traditional risk factors and not on occupational divisions or characteristics in Sweden. However, older individuals living with those who likely cannot work from home or work in delivery or postal services were a vulnerable group.

PMID:34665872 | DOI:10.5271/sjweh.3992

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Increasing Black, Indigenous and People of Color participation in clinical trials through community engagement and recruitment goal establishment

PLoS One. 2021 Oct 19;16(10):e0258858. doi: 10.1371/journal.pone.0258858. eCollection 2021.

ABSTRACT

Longstanding social and economic inequities elevate health risks and vulnerabilities for Black, Indigenous and People of Color (BIPOC) communities. Engagement of BIPOC communities in infectious disease research is a critical component in efforts to increase vaccine confidence, acceptability, and uptake of future approved products. Recent data highlight the relative absence of BIPOC communities in vaccine clinical trials. Intentional and effective community engagement methods are needed to improve BIPOC inclusion. We describe the methods utilized for the successful enrollment of BIPOC participants in the U.S. Government (USG)-funded COVID-19 Prevention Network (CoVPN)-sponsored vaccine efficacy trials and analyze the demographic and enrollment data across the efficacy trials to inform future efforts to ensure inclusive participation. Across the four USG-funded COVID-19 vaccine clinical trials for which data are available, 47% of participants enrolled at CoVPN sites in the US were BIPOC. White enrollment outpaced enrollment of BIPOC participants throughout the accrual period, requiring the implementation of strategies to increase diverse and inclusive enrollment. Trials opening later benefitted considerably from strengthened community engagement efforts, and greater and more diverse volunteer registry records. Despite robust fiscal resources and a longstanding collaborative and collective effort, enrollment of White persons outpaced that of BIPOC communities. With appropriate resources, commitment and community engagement expertise, the equitable enrollment of BIPOC individuals can be achieved. To ensure this goal, intentional efforts are needed, including an emphasis on diversity of enrollment in clinical trials, establishment of enrollment goals, ongoing robust community engagement, conducting population-specific trials, and research to inform best practices.

PMID:34665829 | DOI:10.1371/journal.pone.0258858

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Characteristics of patients in platform C19, a COVID-19 research database combining primary care electronic health record and patient reported information

PLoS One. 2021 Oct 19;16(10):e0258689. doi: 10.1371/journal.pone.0258689. eCollection 2021.

ABSTRACT

BACKGROUND: Data to better understand and manage the COVID-19 pandemic is urgently needed. However, there are gaps in information stored within even the best routinely-collected electronic health records (EHR) including test results, remote consultations for suspected COVID-19, shielding, physical activity, mental health, and undiagnosed or untested COVID-19 patients. Observational and Pragmatic Research Institute (OPRI) Singapore and Optimum Patient Care (OPC) UK established Platform C19, a research database combining EHR data and bespoke patient questionnaire. We describe the demographics, clinical characteristics, patient behavior, and impact of the COVID-19 pandemic using data within Platform C19.

METHODS: EHR data from Platform C19 were extracted from 14 practices across UK participating in the OPC COVID-19 Quality Improvement program on a continuous, monthly basis. Starting 7th August 2020, consenting patients aged 18-85 years were invited in waves to fill an online questionnaire. Descriptive statistics were summarized using all data available up to 22nd January 2021.

FINDINGS: From 129,978 invitees, 31,033 responded. Respondents were predominantly female (59.6%), white (93.5%), and current or ex-smokers (52.6%). Testing for COVID-19 was received by 23.8% of respondents, of which 7.9% received positive results. COVID-19 symptoms lasted ≥4 weeks in 19.5% of COVID-19 positive respondents. Up to 39% respondents reported a negative impact on questions regarding their mental health. Most (67%-76%) respondents with asthma, Chronic Obstructive Pulmonary Disease (COPD), diabetes, heart, or kidney disease reported no change in the condition of their diseases.

INTERPRETATION: Platform C19 will enable research on key questions relating to COVID-19 pandemic not possible using EHR data alone.

PMID:34665843 | DOI:10.1371/journal.pone.0258689

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Photophysiological cycles in Arctic krill are entrained by weak midday twilight during the Polar Night

PLoS Biol. 2021 Oct 19;19(10):e3001413. doi: 10.1371/journal.pbio.3001413. eCollection 2021 Oct.

ABSTRACT

Light plays a fundamental role in the ecology of organisms in nearly all habitats on Earth and is central for processes such as vision and the entrainment of the circadian clock. The poles represent extreme light regimes with an annual light cycle including periods of Midnight Sun and Polar Night. The Arctic Ocean extends to the North Pole, and marine light extremes reach their maximum extent in this habitat. During the Polar Night, traditional definitions of day and night and seasonal photoperiod become irrelevant since there are only “twilight” periods defined by the sun’s elevation below the horizon at midday; we term this “midday twilight.” Here, we characterize light across a latitudinal gradient (76.5° N to 81° N) during Polar Night in January. Our light measurements demonstrate that the classical solar diel light cycle dominant at lower latitudes is modulated during Arctic Polar Night by lunar and auroral components. We therefore question whether this particular ambient light environment is relevant to behavioral and visual processes. We reveal from acoustic field observations that the zooplankton community is undergoing diel vertical migration (DVM) behavior. Furthermore, using electroretinogram (ERG) recording under constant darkness, we show that the main migratory species, Arctic krill (Thysanoessa inermis) show endogenous increases in visual sensitivity during the subjective night. This change in sensitivity is comparable to that under exogenous dim light acclimations, although differences in speed of vision suggest separate mechanisms. We conclude that the extremely weak midday twilight experienced by krill at high latitudes during the darkest parts of the year has physiological and ecological relevance.

PMID:34665816 | DOI:10.1371/journal.pbio.3001413