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Nevin Manimala Statistics

Risk of Severe Acute Localized Reactions for Different Intraarticular Hyaluronic Acid Knee Injections in a Real-World Setting

Cartilage. 2021 Sep 13:19476035211025815. doi: 10.1177/19476035211025815. Online ahead of print.

ABSTRACT

OBJECTIVE: Case reports of severe acute localized reactions (SALR) following intraarticular (IA) hyaluronic acid (HA) injections for knee osteoarthritis (OA) have been described. We compared surrogate SALR measures between patients using hylan G-F 20 and specific non-hylan G-F 20 HA products.

DESIGN: Knee OA patients were identified from the Optum Clinformatics dataset (January 2006 to June 2016), stratified into hylan G-F 20 and non-hylan G-F 20 HA users, matched by single or multiple injection products. Occurrences of surrogate SALR measures including inflammation/infection, intraarticular corticosteroid (CS) injections, arthrocentesis/aspiration, arthrotomy/incision and drainage, and arthroscopy were evaluated within 3 days post-HA.

RESULTS: Based on 694,404 HA injections, inflammation/infection rate was rare within 3 days of HA (up to 0.03%), with no statistical differences between hylan G-F 20 and non-hylan G-F 20 groups (matched by single or multiple injection products). The risk of knee arthrotomy/incision and drainage, arthroscopy, or arthrocentesis for hylan G-F 20 (2 mL) 3 weekly injection patients was lower than Hyalgan/Supartz and Orthovisc patients, but greater than Euflexxa patients. Overall, we found that Hylan G-F 20 (2 mL) 3 weekly injection had lower SALR rates compared to Hyalgan/Supartz and Orthovisc. However, Hylan G-F 20 (2 mL) 3 weekly injection had slightly higher rates of SALR when compared to Euflexxa. Among the single injection products, Hylan G-F 20 (6 mL) single injection had lower rates of SALR than Monovisc and Gel-One.

CONCLUSIONS: This study shows no clear correlation between avian-derived or cross-linked products and SALR and provides evidence against avian-derived products or crosslinking as a source for these reactions.

PMID:34515539 | DOI:10.1177/19476035211025815

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Nevin Manimala Statistics

Usefulness of red cell distribution width to predict mortality in patients undergoing endovascular repair of abdominal aortic aneurysms

Int Angiol. 2021 Sep 13. doi: 10.23736/S0392-9590.21.04725-8. Online ahead of print.

ABSTRACT

BACKGROUND: Red cell distribution width (RDW) reflecting impaired erythropoyesis, has been associated with poor prognosis and mortality in several conditions. The aim of this study was to determine the relationship between RDW and the 5-year survival after the endovascular repair of abdominal aortic aneurysms (EVAR) and its ability to improve the discriminative power of a survival predictive score.

METHODS: Retrospective analysis of 284 patients undergoing EVAR at a single centre. The pattern of relationship between RDW and survival was assessed with penalized smoothing splines. Categorized RDW values were added to a predictive score based in standard preoperative variables, whose improvement in discriminative power was calculated on the basis of changes in the C-statistics and the continuous Net Reclassification Index (c-NRI).

RESULTS: The survival rate at 5 years was 66.2% and was independently associated with hemoglobin (HR=0.85,p<0.004), statin intake (HR=0.54,p<0.004), heart failure (HR=2.53,p<0.018), atrial fibrillation (HR=2.53,p<0.000) and the non-revascularized coronary artery disease (HR=2.15, p<0.005). The relationship between RDW values and 5-year survival was linear. RDW-CV and RDW-SD were categorized to cut-off values of ≥15% (n=83,29.2%) and ≥50 fL (n=82, 28.9%) that were independently associated with poorer 5-year survival rates (HR=2.03,CI95%=1.29-3.19,p=0.002 and HR=1.89, CI95%=1.21-2.95,p=0.005, respectively). The addition of the RDW CV or the RDW-SD to the baseline predictive score significantly improved the c-NRI (0.437,p<0.001 and 0.442,p<0.001, respectively).

CONCLUSIONS: High preoperative RDW levels were linear and adversely related to 5-year survival after EVAR, improved the discriminative power of a predictive score based in standard preoperative variables and may help in decision-making at the time of surgical planning.

PMID:34515451 | DOI:10.23736/S0392-9590.21.04725-8

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Nevin Manimala Statistics

Development and Validation of an Instrument in Spanish to Evaluate Patient Satisfaction in Telemedicine Consultation During COVID-19 Pandemic

Telemed J E Health. 2021 Sep 9. doi: 10.1089/tmj.2021.0320. Online ahead of print.

ABSTRACT

Background: The COVID-19 pandemic prompted health organizations to use telemedicine as an option to continue providing medical services. There is no telemedicine patient satisfaction survey validated in Spanish. Aim of the study: To develop and validate a telemedicine patient satisfaction survey and know the level of satisfaction with this type of consultation implemented at Hospital Clinica Nova during the COVID-19 pandemic. Methods: This was a qualitative study implemented in a private hospital in Monterrey, Mexico, of patients who attended telemedicine from April to August 2020. Content validity was obtained by a two-round Delphi study with the participation of 11 experts. We conducted six patient interviews for the apparent validity of the items. The questionnaire was administered to 120 patients for statistical analysis. We made an item reduction by interitem and item-total correlation analyses, stability validation by a test-retest, a test of reliability by Cronbach’s alpha, and extraction of factors by a factorial analysis. Results: We obtained a validated nine-item questionnaire, eight items on a Likert scale (range 1-7), and one for a Net Promoter Score (NPS). Two factors explained the structure of the questionnaire and it had an Cronbach alpha = 0.86. The mean population satisfaction score was 6.35 and 43% in NPS. Discussion: In general, good satisfaction results were obtained, and most patients considered telemedicine as good as face-to-face consultation. Conclusions: The scale developed was valid and reliable for the hospital population. However, due to the characteristics of the items, it may apply to other Spanish-speaking health organizations that use telemedicine for patient care.

PMID:34515522 | DOI:10.1089/tmj.2021.0320

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Nevin Manimala Statistics

Therapeutic stays of Belarusian children in Italy: evaluation of their mental status, psychological consequences and physical health status

Minerva Pediatr (Torino). 2021 Sep 13. doi: 10.23736/S2724-5276.21.06385-0. Online ahead of print.

ABSTRACT

BACKGROUND: Therapeutic stays are a phenomenon of temporary reception of unaccompanied foreign children from contaminated areas in Belarus, Ukraine and Russia. Aim of the study was to analyze the physical and mental health status of children in therapeutic stays in Italy and the possible presence of a state of child abuse and neglect.

METHODS: The survey was conducted on a total of 55 children, 25 of which belonging to the treatment group composed of 25 Belarusian children in temporary stays in Italy, and the remaining 30 to the control group composed of 30 italian children. Data were collected between July, 2019 and July, 2020. The evaluation included a careful medical history, an accurate physical examination and an interview, focusing on several factors that can be use as indicators of child maltreatment, intended as physical and emotional neglect.

RESULTS: The survey was conducted on a total of 55 children, 25 of which belonging to the treatment group, and the remaining 30 to the control group. Of the 25 children in the treatment group, 8 (32%) are male and 17 (68%) are female, while of the 30 children in the control group, 14 (47%) are male and 16 are female (53%). For each child, we considered the body-mass index (BMI), the presence of dental caries, and the showing of learning disabilities or hypoacusis. These parameters can be used as indicators of child maltreatment. The analysis of BMI in the two groups shows that the BMI in the treatment group is significantly lower than the BMI in the control group (p=0.004). In the treatment group 7 (28%) children showed some form of caries whereas in the control group no forms of caries were detected. This result itself shows quite a relevant trend, and to have a quantitative measure of its statistical significancy, we performed a permutation test. The results show that the incidence of dental caries in the treatment group is significantly higher than in the control group (p=0.0023). We used the same procedure to analyse data on the presence of learning disabilities or hypoacusis. The p-values we obtained are not significant, but the results still seem to show that there might be a trend of a higher incidence of learning disabilities and hypoacusis in the treatment group, and an extensive study with a larger sample might shed more light on the topic.

CONCLUSIONS: This study shows that there are indications that suggest a higher risk of child maltreatment in the group of Belarusian children, where maltreatment is understood as physical and emotional neglect to which children are subjected in the institutions and in the group homes where they live. Despite showing only partially significant results, our work could be a starting point for more extensive studies on the topic. These future studies could be extended to other larger samples and other potential maltreatment factors could be evaluated.

PMID:34515445 | DOI:10.23736/S2724-5276.21.06385-0

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Nevin Manimala Statistics

Telangiectasia diameter in response to thermal stimulus: experimental data and possible clinical applications

Int Angiol. 2021 Sep 13. doi: 10.23736/S0392-9590.21.04693-9. Online ahead of print.

ABSTRACT

BACKGROUND: Telangiectasias are dilated blood vessels on the skin that develop progressively as a consequence of several diseases, including chronic venous disease. The skin blood flow has differences compared to the rest of the circulatory system. These vessels have a permanent vasoconstrictor tone that can respond to vasoconstriction/vasodilation stimulative substances and higher or lower temperatures. This study aims to investigate any possible telangiectasias vasoconstriction or vasodilation in response to temperature changes.

METHODS: This is a clinical trial with 26 outpatients of vascular surgery with telangiectasias in the lower limbs. We used direct skin digital microscopy to obtain telangiectasias images at room temperature and after the thermal stimulus with cold pads. These photographs were processed using AmScopeAmLite and the capillary diameter and area were measured in Adobe Illustrator. The data collected was analyzed in SPSS Statistics with a paired t-test for the telangiectasias area and a Wilcoxon matched-pairs signed-rank test for the telangiectasias diameter.

RESULTS: In comparison to telangiectasias measures at room temperature, we found a statistically significant decrease in the diameter (median of -0.04 mm; interquartile range: -0.10 mm to -0.01 mm; p <0.001) and area (mean of -26.54 mm2; 95% Confidence interval (-36.31, -16.76) mm2; p <0.001 in response to the cold stimulus.

CONCLUSIONS: Telangiectasias respond to cold patch application with a significantly statistical microscale quantifiable vasoconstriction. This intervention has the potential to improve the current state of telangiectasias sclerotherapy due to its mechanism helping to stabilize the applied foam. We speculate that topic cold used as a neoadjuvant treatment could improve the efficiency, stability, and other outcomes of sclerotherapy. Also, complementary use of topical cold stimulus application may be of interest in the therapeutic management of telangiectasias.

PMID:34515449 | DOI:10.23736/S0392-9590.21.04693-9

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Nevin Manimala Statistics

The correlation between full moon and admission volume for penetrating injuries at a major trauma centre in South Africa

S Afr J Surg. 2021 Sep;59(3):94-96.

ABSTRACT

BACKGROUND: The possible effect of full moon on admission volume of trauma centres is a well-mentioned phenomenon that has been perpetuated worldwide. We aimed to review the correlation between full moon and admission volume and to interrogate any possible relationship on admission for penetrating trauma.

METHODS: A retrospective study from 2012 to 2018 at Pietermaritzburg Metropolitan Trauma Service (PMTS), South Africa.

RESULTS: A total of 8 722 patients were admitted. Eighty-three per cent (7 242/8 722) were male and the mean age was 29 years. The total number of days during the study period was 1 953, 66 of which were ‘full moon’ (FM) days and 1 887 were ‘non-full moon’ (NFM) days. There was no significant difference between gender or age distribution. The mean number of admissions per day on FM days compared with NFM days was not significant (4.1 vs 4.5, p = 0.583). A total of 3 332 patients with penetrating trauma were admitted. This constituted 42% (113/271) of admission on FM days and 38% (3 219) on NFM days, which is not statistically significant (p = 0.229). Subgroup analysis did not demonstrate any significant difference between the number of stab wounds – 28% (77/113) vs 25% (2 124/3 219) – or gunshot wounds – 13% (16/113) vs 12% (990/3 219) – between FM and NFM days.

CONCLUSION: The correlation between full moon and trauma admission is unfound in our setting. The perpetuating notion that ‘it must be full moon tonight’ is likely to be an urban myth with no scientific evidence for such a claim.

PMID:34515424

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Early intra-articular corticosteroid injection is predictors of remission of juvenile idiopathic arthritis

Minerva Pediatr (Torino). 2021 Sep 13. doi: 10.23736/S2724-5276.21.06343-6. Online ahead of print.

ABSTRACT

BACKGROUND: to assess predictors of remission in children with Juvenile Idiopathic Arthritis (JIA), treated with intraarticular corticosteroid injection (IACI) as monotherapy or in combination with Methotrexate (MTX).

METHODS: a retrospective study of 43 patients diagnosed with different JIA subtypes and followed-up at a tertiary centre between 2000 and 2014. We included patients treated with IACI as monotherapy or in combination with MTX at onset or thereafter. We excluded patients treated with MTX as monotherapy or in combination with biologics. Patients were divided into two groups on the basis of assigned treatment. Primary outcomes were disease remission and duration. We performed descriptive analysis, bivariate analysis and cross-correlation analysis between variables. Statistically significant results (pvalue <0.05) were chosen as variables for multivariate analysis.

RESULTS: Median age of onset was 4.56 years (SD ± 3.85). Median time between disease onset and first IACI was 16.9 months (SD ± 34.7). We evaluated between time to remission in relation to age, time interval between onset and first IACI, time between onset and start of treatment with MTX, and time between first and second IACI. All of these were statistically significant (p-value <0.05) in bivariate analysis, but time between onset and first IACI was the only statistically significant result, using multiple linear regression analysis. Therefore, in our study, 37 patients (86%) of patients went into remission on medication after a median disease duration of 48.8 months.

CONCLUSIONS: We found that remission was related to time between onset and first IACI. Our predictive model showed that early IACI can be considered as a strong predictor of remission.

PMID:34515444 | DOI:10.23736/S2724-5276.21.06343-6

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Nevin Manimala Statistics

Reflexology and meditative practices for symptom management among people with cancer: Results from a sequential multiple assignment randomized trial

Res Nurs Health. 2021 Oct;44(5):796-810. doi: 10.1002/nur.22169. Epub 2021 Jul 19.

ABSTRACT

Optimal sequencing of complementary therapies can help improve symptom management through nonpharmacological approaches. A 12-week sequential multiple assignment randomized trial comparing home-based reflexology and meditative practices on severity of fatigue and other symptoms was conducted among patients with cancer and their informal caregivers. Dyads were initially randomized to reflexology (N = 150), meditative practices (N = 150), or control (N = 47). If patient’s fatigue did not improve (nonresponse) after 4 weeks of reflexology or meditative practices, the dyad was rerandomized to either add the other therapy or continue with the original therapy for weeks 5-8. Four decision rules (DRs) were compared: (1) Initiating reflexology, and if nonresponse on fatigue after 4 weeks, continue with reflexology for another 4 weeks, thus providing a higher dose; (2) Initiating reflexology, and if nonresponse on fatigue after 4 weeks, add meditative practices for the next 4 weeks; (3) Initiating meditative practices, and if nonresponse on fatigue after 4 weeks, continue meditative practices for another 4 weeks, thus providing a higher dose; and (4) Initiating meditative practices, and if nonresponse on fatigue after 4 weeks, add reflexology for the next 4 weeks. Symptoms were evaluated weekly using the M.D. Anderson Symptom Inventory (MDASI). Clinically, nurses can recommend either therapy since no differences were found among the 4 DRs, with the exception of lower severity for summed MDASI symptoms at week 8 for the use of reflexology only (DR-1) versus DR-2 (sequencing reflexology to meditative practices). Adding the other therapy for nonresponders after 4 weeks may not be warranted.

PMID:34515341 | DOI:10.1002/nur.22169

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Nevin Manimala Statistics

Rejoinder to “On the robustness of latent class models for diagnostic testing with no gold standard”

Stat Med. 2021 Sep 30;40(22):4770-4771. doi: 10.1002/sim.9157.

NO ABSTRACT

PMID:34515367 | DOI:10.1002/sim.9157

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Nevin Manimala Statistics

Glutamine anaplerosis is required for amino acid biosynthesis in human meningiomas

Neuro Oncol. 2021 Sep 13:noab219. doi: 10.1093/neuonc/noab219. Online ahead of print.

ABSTRACT

BACKGROUND: We postulate that meningiomas undergo distinct metabolic reprogramming in tumorigenesis and unravelling their metabolic phenotypes provide new therapeutic insights. Glutamine catabolism is key to the growth and proliferation of tumors. Here, we investigated the metabolomics of freshly resected meningiomas and glutamine metabolism in patient-derived meningioma cells.

METHODS: 1H NMR spectroscopy of tumor tissues from 33 meningioma patients was used to differentiate the metabolite profiles of grade-I and grade-II meningiomas. Glutamine metabolism was examined using 13C/ 15N glutamine tracer, in five patient-derived meningioma cells.

RESULTS: Alanine, lactate, glutamate, glutamine, and glycine were predominantly elevated only in grade-II meningiomas by 74%, 76%, 35%, 75% and 33% respectively, with alanine, and glutamine being statistically significant (p ≤ 0.02). 13C/ 15N glutamine tracer experiments revealed that both grade-I and -II meningiomas actively metabolize glutamine to generate various key carbon intermediates including alanine and proline that are necessary for the tumor growth. Also, it is shown that glutaminase (GLS1) inhibitor, CB-839 is highly effective in downregulating glutamine metabolism and decreasing proliferation in meningioma cells.

CONCLUSION: Alanine and glutamine/glutamate are mainly elevated in grade-II meningiomas. Grade-I meningiomas possess relatively higher glutamine metabolism providing carbon/nitrogen for the biosynthesis of key nonessential amino acids. GLS1 inhibitor (CB-839) would be very effective in downregulating glutamine metabolic pathways in grade-I meningiomas leading to decreased cellular proliferation.

PMID:34515312 | DOI:10.1093/neuonc/noab219