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The development and validation of a multivariable model to predict the bleeding risk score for patients with non-valvular atrial fibrillation using direct oral anticoagulants in the Arab population

PLoS One. 2021 May 3;16(5):e0250502. doi: 10.1371/journal.pone.0250502. eCollection 2021.

ABSTRACT

BACKGROUND: Frequently used models, such as the HAS-BLED, ATRIA, ORBIT, and GARFIELD-AF evaluate the risk of bleeding when using an anticoagulant, for example warfarin, in patients with non-valvular atrial fibrillation. Limited studies are available reporting a model with a good discriminative ability to predict the bleeding risk score when using direct oral anticoagulants.

METHODS: Patient data were collected from King Abdulaziz Medical City, King Fahad Cardiac Center, and Prince Sultan Cardiac Center in Riyadh, from outpatients, inpatients, or primary care clinics. In total, 1722 patients with a prescription for a new oral anticoagulant, Dabigatran, Rivaroxaban, or Apixaban, were enrolled. A resampling approach for variable selection was used and a five-fold cross-validation to assess the model fit and misclassification probabilities. The analysis used the receiver operating characteristics curve (ROC) and the concordance (c) statistic to assess the validation models’ discriminative power. The final penalized likelihood parameters were used for the development of the risk prediction tool. The accuracy of a classification and the prediction are reported with the sensitivity, specificity, and Brier score.

RESULTS: Bleeding occurred in 11.15% of cases, of which 23.08% required a blood transfusion and 51.65% had a reduction in haemoglobin of more than 2 gm. The variable selection model identified 15 predictors associated with major bleeding. The discriminative ability of the model was good (c-statistic 0.75, p = 0.035). The Brier score of the model was 0.095. With a fixed cut-off probability value of 0.12 for the logistic regression equation, the sensitivity was 72.7%, and the specificity 66.3%.

CONCLUSION: This model demonstrated a good performance in predicting the bleeding risk in Arab patients treated with novel oral anticoagulants. This easy to use bleeding risk score will allow the clinician to quickly classify patients according to their risk category, supporting close monitoring and follow-up for high-risk patients, without laboratory and radiological monitoring.

PMID:33939729 | DOI:10.1371/journal.pone.0250502

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Prevalence of clinical malaria and household characteristics of patients in tribal districts of Pakistan

PLoS Negl Trop Dis. 2021 May 3;15(5):e0009371. doi: 10.1371/journal.pntd.0009371. Online ahead of print.

ABSTRACT

BACKGROUND: Malaria, disproportionately affects poor people more than any other disease of public health concern in developing countries. In resource-constrained environments, monitoring the occurrence of malaria is essential for the success of national malaria control programs. Militancy and military conflicts have been a major challenge in monitoring the incidence and controlling malaria and other emerging infectious diseases. The conflicts and instability in Afghanistan have resulted in the migration of refugees into the war-torn tribal districts of Pakistan’s Khyber Pakhtunkhwa (KPK) province and the possible introduction of many contagious epidemics. Although malaria is very common in all tribal districts, molecular, clinical and epidemiological data are scarce in these high-burden districts. Therefore, for the proper surveillance, detection, and control of malaria, obtaining and analyzing reliable data in these districts is essential.

METHODOLOGY/PRINCIPAL FINDINGS: All 1,127 malaria-suspected patients were sampled within the transmission season in the tribal districts of KPK province between March 2016 to December 2018. After a detailed demographic and clinical investigation of malaria-suspected patients, the data were recorded. The data of the control group was collected simultaneously at the same site. They were considered as uncomplicated cases for statistical analyses. Blood samples were collected from malaria-suspected patients for the detection of Plasmodium species using microscopy and nested PCR (nPCR). Microscopy and nPCR examination detected 78% (n = 882) and 38% (n = 429) Plasmodium-positive patients, respectively. Among1,127 of 429nPCR detected cases with both species of malaria, the frequency of complications was as follows: anemia (n = 71; 16.5%), decompensated shock (n = 40; 9%), hyperpyrexia (n = 117; 27%), hyperparasitaemia (n = 49; 11%) hypoglycemia (n = 45; 10.5%), jaundice (n = 54; 13%), multiple convulsions (n = 37; 9%), and petechia (n = 16; 4%). We observed that 37% (n = 157 out of 429) of those patients infected by both Plasmodium species were children between the ages of 1 and 15 years old. The results revealed that Bajaur (24%), Kurram (20%), and Khyber (18%) districtshada higher proportion of P. vivax than P. falciparum cases. Most of the malaria cases were males (74%). Patients infected by both Plasmodium species tended to less commonly have received formal education and ownership of wealth indicators (e.g., fridge, TV set) was lower.

CONCLUSIONS/SIGNIFICANCE: Malaria in tribal districts of the KPK province largely affects young males. P. vivax is a major contributor to the spread of malaria in the area, including severe malaria. We observed a high prevalence of P. vivax in the Bajaur district. Children were the susceptible population to malaria infections whereas they were the least expected to use satisfactory prevention strategies. A higher level of education, a possession of TV sets, the use of bed nets, the use of repellent fluids, and fridges were all associated with protection from malaria. An increased investment in socio-economic development, a strong health infrastructure, and malaria education are key interventions to reduce malaria in the tribal districts.

PMID:33939717 | DOI:10.1371/journal.pntd.0009371

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Simple robots, smart algorithms

Inspired by a theoretical model of particles moving around on a chessboard, new robot swarm research shows that, as magnetic interactions increase, dispersed ‘dumb robots’ can abruptly gather in large, compact clusters to accomplish complex tasks. Researchers report that these ‘BOBbots’ (behaving, organizing, buzzing bots) are also capable of collectively clearing debris that is too heavy for one alone to move, thanks to a robust algorithm.
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Comparative Study of Intralesional Vitamin D3 Injection and Candida Albicans Antigen in Treating Plantar Warts

J Drugs Dermatol. 2021 May 1;20(5):546-549. doi: 10.36849/JDD.5264.

ABSTRACT

BACKGROUND: Warts, or verrucae, are mucosal human papilloma virus (HPV) infections that are very challenging to treat.

OBJECTIVE: To compare the safety and efficacy of intralesional injection of vitamin D3 versus intralesional injection of candida albicans antigen for plantar warts.

METHODS: Forty patients were included in the study and were divided into two groups (A&B) with 20 patients each. Group A received intralesional vitamin D3 while Group B received intralesional Candida antigen. Injection was done every 3 weeks until clearance of warts or a maximum of three treatments.

RESULTS: Nine patients showed complete clearance in group A (45%), while 6 patients (30%) showed partial response and no response in 5 patients (25%) of group (A). As for group (B), complete clearance of the treated warts was observed in 8 patients (40%), partial response in 6 patients (30%) while no response was observed in 6 patients (30%). No superiority of one treatment to the other was observed nor was any statistical significance in both groups’ responses noted.

CONCLUSION: Treatment of multiple warts by intralesional injection of candida antigen or vitamin D3 is safe and effective, with good cure rates, has an excellent safety profile, with minimal recurrences and statistically equivalent. J Drugs Dermatol. 2021;20(5):546-549. doi:10.36849/JDD.5264.

PMID:33938709 | DOI:10.36849/JDD.5264

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The Effect on BSA of Proactive Management versus Reactive Management of Psoriasis With Fixed-Dose Cal/BD Foam in the PSO-LONG Study

J Drugs Dermatol. 2021 May 1;20(5):567-570. doi: 10.36849/JDD.5870.

ABSTRACT

Reduction of psoriasis body surface area (BSA) is associated with improved patient quality of life. Post-hoc analyses of the PSO-LONG study compared impact on BSA of proactive management versus reactive management strategies using calcipotriol/betamethasone dipropionate (Cal/BD) foam. Mean BSA values, as well as normalized area under the curves (AUCs) for patient BSA were assessed. Analyses found that after the PSO-LONG study’s four-week open-label lead-in phase, when all patients received once-daily Cal/BD foam, mean BSA was significantly reduced. Thereafter, mean BSA remained at lower levels in patients on proactive management compared to reactive management. This was reflected in AUC BSA, which was consistently lower in the proactive management arm. Treatment-related differences were statistically significant when analyzing the full analysis set (FAS) population, as well as when restricting the analysis to study completers. Additional analyses restricted the dataset to include only observations from psoriasis remission periods, or periods of disease relapse. Treatment-related differences in AUC were statistically significant in observations during remission, but not during relapse. This could be expected given the trial’s design, wherein all patients who relapsed were offered the same rescue therapy with once daily Cal/BD foam. Similarly, for patients who dropped out, there was no treatment-related difference in mean BSA during the two weeks preceding dropout, likely due to the common occurrence of relapse in these patients. This paper found that proactive management, in addition to preventing more relapses as previously shown, also maintained BSA at a lower level during remission than reactive management. J Drugs Dermatol. 20(5):567-570. doi:10.36849/JDD.5870.

PMID:33938704 | DOI:10.36849/JDD.5870

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Randomized, Double-Blind, Placebo-Controlled Study of Poly-L-Lactic acid for Treatment of Cellulite in the Lower Extremities

J Drugs Dermatol. 2021 May 1;20(5):529-533. doi: 10.36849/JDD.5380.

ABSTRACT

BACKGROUND: Poly-l-lactic acid (PLLA) is an injectable volumizer with biostimulatory properties used for volumetric structural rejuvenation in patients with facial fat volume loss but has increasingly been utilized for off-face applications.

OBJECTIVE: The objectives of this randomized, double-blind, placebo-controlled single center study was to assess the safety and effectiveness of PLLA for the treatment of lower extremity cellulite in adult women.

METHODS: 31 healthy women were enrolled in the study. Eligible subjects received 3 treatments every 4 weeks with either PLLA (treatment group) or saline (control group) injections combined with subcision, into each of the glutes or thighs. Follow-up visits were at 1, 3, and 6 months after treatment. Assessments included live ratings, rating of standardized pictures by a blinded evaluator, patient questionnaires, safety, and tolerability ratings.

RESULTS: At the 3 and 6-month follow-up, there was a statistically significant change in the global aesthetic improvement scale (GAIS) compared to baseline as assessed by blinded investigators. Significant improvements were shown in the cellulite severity scale (CSS) as well as in the subject satisfaction questionnaires. Treatments were found to be tolerable, and no severe treatment-related adverse events occurred.

CONCLUSION: Repeated PLLA treatments combined with subcision are effective and safe in improving the appearance of cellulite. J Drugs Dermatol. 20(5): doi:10.36849/JDD.5380.

PMID:33938690 | DOI:10.36849/JDD.5380

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Influence of Rheological Properties and Needle Size on Extrusion Forces of Hyaluronic Acid Based Soft Tissue Fillers

J Drugs Dermatol. 2021 May 1;20(5):498-502. doi: 10.36849/JDD.5237.

ABSTRACT

BACKGROUND: To date no precise data are available for extrusion forces related to the G-prime and G-double-prime of fillers in combination with different 27G and 30G needles. Therefore, the objective of this study was to analyze extrusion forces of various product-needle-combinations containing two different 27G and two different 30G needles in combination with fillers of a wide range of elastic moduli starting from 2.0 – 166.0 Pa.

MATERIAL AND METHODS: Four different fillers with the following elastic moduli 1.87, 11.65, 61.80, 165.50 Pa were combined with four different needles: 27G ½”, internal diameter: 0.300 μm; 27G ½”, internal diameter: 0.241 μm; 30G ½”, internal diameter: 0.241 μm and 30G ½“, internal diameter: 0.240 μm. Product-needle-combination were subjected to uni-axial mechanical testing and the respective extrusion force was measured.

RESULTS: The results of this study revealed that the G-prime and the G-double-prime of a product are statistically significantly related to their extrusion force, with higher G-prime/G-double-prime products requiring higher extrusion forces. The results additionally revealed that whether the size of the needle was described as 27G or 30G by the respective manufacturer statistically significant differences between the measured extrusion forces were detected.

CONCLUSION: Injectors need to be aware that not every 27G/30G needle has the same extrusion force even though the external diameter is similar (27G or 30G); this might additionally influence the ability to withdraw blood during a pre-injection aspiration manoeuvre. J Drugs Dermatol. 20(5): doi:10.36849/JDD.5237.

PMID:33938685 | DOI:10.36849/JDD.5237

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Comparison of ropivacaine plasma concentration after posterior Quadratus Lumborum Block in Cesarean Section with ropivacaine with epinephrine vs plane

Minerva Anestesiol. 2021 May 3. doi: 10.23736/S0375-9393.21.15354-4. Online ahead of print.

ABSTRACT

BACKGROUND: The posterior Quadratus Lumborum Block (pQLB) has been used in postoperative pain management after Cesarean Section (CS). However, clinicians have no data about pQLB safety in pregnants, at increased risk of local anesthetic systemic toxicity (LAST). The purpose of the present study was to explore the efficacy and the safety of adding epinephrine to ropivacaine for bilateral pQLB vs. bilateral pQLB performed with ropivacaine alone in CS.

METHODS: in this prospective trial 52 pregnants, ASA 2 physiological status, were consecutively allocated to one of 2 groups, e-pQLB and pQLB; e-pQLB group received 0.375% ropivacaine+100 mcg epinephrine, 20 ml each side; pQLB received 0.375% ropivacaine alone, 20 ml each side. The primary and secondary outcomes were to evaluate if the adjunct of epinephrine to ropivacaine increases efficacy and safety of pQLB, respectively.

RESULTS: Authors found in e-pQLB group vs. p-QLB group: a total mean morphine consumption statistically lower during the first 24 postoperative hours (5.08±3.12, vs 9.11±4.67 SD mg, p=0.0002); NRS values statistically lower at 6 hours from block, both at rest (1,73±1,88 SD vs. 2,88±2,53, p=0.03) and with movement (3,03±1,98 SD vs. 4,23±2,87, p=0.04); a longer time between block and the first opioid request (5.92±2.48 vs 3.78±2.68 SD hrs, p< 0.003); venous ropivacaine concentrations significantly lower at any time of samples but at 120 minutes.

CONCLUSIONS: Adding epinephrine to ropivacaine increases efficacy and duration of pQLB. Moreover it increases block safety, reducing peak and mean venous ropivacaine concentration.

PMID:33938678 | DOI:10.23736/S0375-9393.21.15354-4

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A New Method for Aortic Valve Planimetry with High-Resolution 3-Dimensional MRI and Its Comparison with Conventional Cine MRI and Echocardiography for Assessing the Severity of Aortic Valvular Stenosis

Korean J Radiol. 2021 Apr 23. doi: 10.3348/kjr.2020.1218. Online ahead of print.

ABSTRACT

OBJECTIVE: We aimed to compare the aortic valve area (AVA) calculated using fast high-resolution three-dimensional (3D) magnetic resonance (MR) image acquisition with that of the conventional two-dimensional (2D) cine MR technique.

MATERIALS AND METHODS: We included 139 consecutive patients (mean age ± standard deviation [SD], 68.5 ± 9.4 years) with aortic valvular stenosis (AS) and 21 asymptomatic controls (52.3 ± 14.2 years). High-resolution T2-prepared 3D steady-state free precession (SSFP) images (2.0 mm slice thickness, 10 contiguous slices) for 3D planimetry (3DP) were acquired with a single breath hold during mid-systole. 2D SSFP cine MR images (6.0 mm slice thickness) for 2D planimetry (2DP) were also obtained at three aortic valve levels. The calculations for the effective AVA based on the MR images were compared with the transthoracic echocardiographic (TTE) measurements using the continuity equation.

RESULTS: The mean AVA ± SD derived by 3DP, 2DP, and TTE in the AS group were 0.81 ± 0.26 cm², 0.82 ± 0.34 cm², and 0.80 ± 0.26 cm², respectively (p = 0.366). The intra-observer agreement was higher for 3DP than 2DP in one observer: intraclass correlation coefficient (ICC) of 0.95 (95% confidence interval [CI], 0.94-0.97) and 0.87 (95% CI, 0.82-0.91), respectively, for observer 1 and 0.97 (95% CI, 0.96-0.98) and 0.98 (95% CI, 0.97-0.99), respectively, for observer 2. Inter-observer agreement was similar between 3DP and 2DP, with the ICC of 0.92 (95% CI, 0.89-0.94) and 0.91 (95% CI, 0.88-0.93), respectively. 3DP-derived AVA showed a slightly higher agreement with AVA measured by TTE than the 2DP-derived AVA, with the ICC of 0.87 (95% CI, 0.82-0.91) vs. 0.85 (95% CI, 0.79-0.89).

CONCLUSION: High-resolution 3D MR image acquisition, with single-breath-hold SSFP sequences, gave AVA measurement with low observer variability that correlated highly with those obtained by TTE.

PMID:33938648 | DOI:10.3348/kjr.2020.1218

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Priorities and preferences for care of people with multiple chronic conditions

Health Expect. 2021 May 3. doi: 10.1111/hex.13262. Online ahead of print.

ABSTRACT

BACKGROUND: To guide the development of high-quality care for people with multiple chronic conditions, partners of the European Joint Action CHRODIS developed the Integrated Multimorbidity Care Model. To assess its suitability for improving care for people with multimorbidity in the Netherlands, the model was piloted in a primary care setting with both patients and care providers.

AIM: This paper reports on the patient perspective, and aims to explore the priorities, underlying values and preferences for care of people with multimorbidity.

PARTICIPANTS AND METHODS: Twenty persons with multimorbidity (selected from general practice registries) participated in a focus group or telephone interview. Subsequently, a questionnaire was completed by 863 persons with multimorbidity registered with 14 general practices. Qualitative data were thematically analysed and quantitative data by means of descriptive statistics.

RESULTS: Frequently prioritized elements of care were the use of shared electronic health records, regular comprehensive assessments, self-management support and shared decision making, and care coordination. Preferences for how these elements should be specifically addressed differed according to individual values (eg weighing safety against privacy) and needs (eg ways of coping with multimorbidity).

CONCLUSION: The JA-CHRODIS Integrated Multimorbidity Care Model reflects the priorities and preferences for care of people with multimorbidity in the Netherlands, which supports its relevance to guide the development of person-centred integrated care for people with multiple chronic conditions in the Netherlands.

PATIENT CONTRIBUTION: European patient experts contributed to the development and applicability assessment of the JA-CHRODIS Integrated Multimorbidity Care Model; Dutch patients participated in focus groups, interviews and a survey.

PMID:33938597 | DOI:10.1111/hex.13262