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Nevin Manimala Statistics

A Novel Afrocentric Stroke Risk Assessment Score: Models from the Siren Study

J Stroke Cerebrovasc Dis. 2021 Jul 28;30(10):106003. doi: 10.1016/j.jstrokecerebrovasdis.2021.106003. Online ahead of print.

ABSTRACT

BACKGROUND: Stroke risk can be quantified using risk factors whose effect sizes vary by geography and race. No stroke risk assessment tool exists to estimate aggregate stroke risk for indigenous African.

OBJECTIVES: To develop Afrocentric risk-scoring models for stroke occurrence.

MATERIALS AND METHODS: We evaluated 3533 radiologically confirmed West African stroke cases paired 1:1 with age-, and sex-matched stroke-free controls in the SIREN study. The 7,066 subjects were randomly split into a training and testing set at the ratio of 85:15. Conditional logistic regression models were constructed by including 17 putative factors linked to stroke occurrence using the training set. Significant risk factors were assigned constant and standardized statistical weights based on regression coefficients (β) to develop an additive risk scoring system on a scale of 0-100%. Using the testing set, Receiver Operating Characteristics (ROC) curves were constructed to obtain a total score to serve as cut-off to discriminate between cases and controls. We calculated sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) at this cut-off.

RESULTS: For stroke occurrence, we identified 15 traditional vascular factors. Cohen’s kappa for validity was maximal at a total risk score of 56% using both statistical weighting approaches to risk quantification and in both datasets. The risk score had a predictive accuracy of 76% (95%CI: 74-79%), sensitivity of 80.3%, specificity of 63.0%, PPV of 68.5% and NPV of 76.2% in the test dataset. For ischemic strokes, 12 risk factors had predictive accuracy of 78% (95%CI: 74-81%). For hemorrhagic strokes, 7 factors had a predictive accuracy of 79% (95%CI: 73-84%).

CONCLUSIONS: The SIREN models quantify aggregate stroke risk in indigenous West Africans with good accuracy. Prospective studies are needed to validate this instrument for stroke prevention.

PMID:34332227 | DOI:10.1016/j.jstrokecerebrovasdis.2021.106003

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Risk prediction of major haemorrhage with surgical treatment of live cesarean scar pregnancies

Eur J Obstet Gynecol Reprod Biol. 2021 Jul 22;264:224-231. doi: 10.1016/j.ejogrb.2021.07.030. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the association between demographic and ultrasound variables and major intra-operative blood loss during surgical transcervical evacuation of live caesarean scar pregnancies.

STUDY DESIGN: This was a retrospective cohort study conducted in a tertiary referral center between 2008 and 2019. We included all women diagnosed with a live caesarean scar ectopic pregnancy who chose to have surgical management in the study center. A preoperative ultrasound was performed in each patient. All women underwent transcervical suction curettage under ultrasound guidance. Our primary outcome was the rate of postoperative blood transfusion. The secondary outcomes were estimated intra-operative blood loss (ml), rate of retained products of conception, need for repeat surgery, need for uterine artery embolization and hysterectomy rate. Descriptive statistics were used to describe the variables. Univariate and multivariable logistic regression models were constructed using the relevant covariates to identify the significant predictors for severe blood loss.

RESULTS: During the study period, 80 women were diagnosed with a live caesarean scar pregnancy, of whom 62 (78%) opted for surgical management at our center. The median crown-rump length was 9.3 mm (range 1.4-85.7). Median blood loss at the time of surgery was 100 ml (range, 10-2300), and six women (10%; 95%CI 3.6-20) required blood transfusion. Crown-rump length and presence of placental lacunae were significant predictive factors for the need for blood transfusion and blood loss > 500 ml at univariate analysis (p < .01); on multivariate analysis, only crown-rump length was a significant predictor for need for blood transfusion (OR = 1.072; 95% CI 1.02-1.11). Blood transfusion was required in 6/18 (33%) cases with the crown-rump length ≥ 23 mm (≥9+0 weeks of gestation), but in none of 44 women presenting with a crown-rump length < 23 mm (p < .01).

CONCLUSION: The risk of severe intraoperative bleeding and need for blood transfusion during or after surgical evacuation of live caesarean scar pregnancies increases with gestational age and is higher in the presence of placental lacunae. One third of women presenting at ≥ 9 weeks of gestation required blood transfusion and their treatment should be ideally arranged in specialized tertiary centers.

PMID:34332219 | DOI:10.1016/j.ejogrb.2021.07.030

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Nevin Manimala Statistics

Long noncoding RNAs as biomarkers for the diagnosis of hepatocellular carcinoma: A meta-analysis

Pathol Res Pract. 2021 Jul 9;224:153546. doi: 10.1016/j.prp.2021.153546. Online ahead of print.

ABSTRACT

BACKGROUND: Long non-coding RNAs (lncRNAs) are often aberrantly expressed in hepatocellular carcinoma (HCC). The role of lncRNAs in the diagnosis of HCC has attracted increasing attention. Hence, we performed a meta-analysis based on current studies to assess the diagnostic value of lncRNAs for HCC.

METHODS: A systematic search was performed using PubMed, Web of Science, and Embase databases for relevant studies. The quality of the studies was assessed with the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2). A fixed-effect model was used if the value of I2 statistics < 50%; otherwise, a bivariate random effects model was applied (I2 ≥ 50%). In addition, subgroup analysis and meta-regression analysis were conducted to explore the sources of heterogeneity. Statistical analyses were based on Meta-Disc statistical software (Version 1.4) and STATA software (Version 15.1).

RESULTS: A total of 52 studies in 20 related articles were selected for this meta-analysis, including 4930 patients and 4614 controls. The pooled sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR), and area under the curve (AUC) were 0.85 [95% confidence interval (CI) 0.82-0.88], 0.76 (95% CI 0.73-0.80), 3.6 (95% CI 3.1-4.2), 0.19 (95% CI 0.16-0.24), 19 (95% CI 14-26), and 0.88 (95% CI 0.85-0.91), respectively. The publication bias was evaluated by the Deek’s funnel plot in our meta-analysis.

CONCLUSIONS: LncRNAs can serve as feasible HCC diagnostic biomarkers. However, further studies are necessary to confirm its diagnostic and clinical value.

PMID:34332221 | DOI:10.1016/j.prp.2021.153546

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Nevin Manimala Statistics

Final 3-year clinical outcomes following transcatheter aortic valve implantation with a supra-annular self-expanding repositionable valve in a real-world setting: Results from the multicenter FORWARD study

Catheter Cardiovasc Interv. 2021 Jul 31. doi: 10.1002/ccd.29889. Online ahead of print.

ABSTRACT

OBJECTIVES: The Evolut R FORWARD study confirmed safety and effectivenesss of the Evolut R THV in routine clinical practice out to 1 year. Herein, we report the final 3-year clinical follow up of the FORWARD study.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a proven alternative to surgery in elderly patients with symptomatic severe aortic stenosis. Long-term clinical outcome data with the Evolut R platform are scarce.

METHODS: FORWARD is a prospective multicenter observational study that evaluated the Evolut R system in routine clinical practice at 53 centres. Eligible patients had symptomatic native aortic valve stenosis or failed surgical aortic bioprosthesis and elevated operative risk per Heart-Team assessment. TAVR was attempted in 1039 patients.

RESULTS: Mean age was 81.8 ± 6.2 years, 64.9% were women, STS score was 5.5 ± 4.5% and 34.2% were frail. Rates of all-cause mortality and disabling stroke were 24.8% and 4.8% at 3 years. Early need for a new pacemaker implantation after TAVR (all-cause mortality: with new PPI; 21.0% vs. without; 22.8%, p = 0.55) and the presence of > trace paravalvular regurgitation (all-cause mortality: no or trace; 22.0% vs. ≥ mild; 25.5%, p = 0.29) did not affect survival. Between 1 and 3 years incidence rates of valve related intervention, endocarditis and clinically relevant valve thrombosis were low.

CONCLUSIONS: The Evolut R valve maintained a favorable safety profile through 3 years in routine clinical practice. Rates of transcatheter heart valve-related adverse events were low.

PMID:34331844 | DOI:10.1002/ccd.29889

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Pancreatic damage in COVID-19: Why? How?

Int J Clin Pract. 2021 Jul 31:e14692. doi: 10.1111/ijcp.14692. Online ahead of print.

ABSTRACT

OBJECT: We aimed to evaluate the elevation of amylase and lipase enzymes in coronavirus disease 2019 (COVID-19) patients and their relationship with the severity of COVID-19.

METHOD: In this study, 1378 patients with COVID-19 infection were included. Relation of elevated amylase and lipase levels and comorbidities with the severity of COVID-19 was analyzed. The effects of hemodynamic parameters and organ failure on pancreatic enzymes and their relations with prognosis were statistically analyzed.

RESULTS: The 1378 patients comprised 700 (51.8%) men and 678 (%49.2) women. Of all patients, 687 (49.9%) had mild and 691 (50.1%) patients had severe COVID-19 infection. Amylase elevation at different levels occurred in 316 (%23) out of 1378 patients. In these patients, the amylase levels increased 1-3 times in 261 and 3 times in 55 patients. Pancreatitis was detected in only 6 (%1.89) of these patients according to the Atlanta criteria. According to univariate and multivariate analyses, elevated amylase levels were significantly associated with the severity of COVID-19 (Odds Ratio [OR]: 4.37; p<0.001). Moreover, diabetes mellitus (DM) (OR: 1.82; p=0.001), kidney failure (OR: 5.18; p<0.001), liver damage (OR: 6.63; p<0.001), hypotension (OR: 6.86; p<0.001), and sepsis (OR: 6.20; p=0.008) were found to be associated with mortality from COVID-19.

CONCLUSION: Elevated pancreatic enzyme levels in COVID-19 infections are related to the severity of COVID-19 infection and hemodynamic instability. In a similar way to other organs, the pancreas can be affected by severe COVID-19 infection.

PMID:34331821 | DOI:10.1111/ijcp.14692

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Evaluation of four pre-operative models for prediction of biochemical recurrence after radical prostatectomy in localized prostate cancer

Int J Clin Pract. 2021 Jul 31:e14682. doi: 10.1111/ijcp.14682. Online ahead of print.

ABSTRACT

BACKGROUND: Biochemical recurrence (BCR) can be seen in the early or late period after radical prostatectomy (RP). Various models have been developed to predict BCR.

OBJECTIVE: In our study we evaluated accuracy of four pre-operative models (GP score, PRIX, D’Amico risk classification, CAPRA) in predicting BCR after RP in Turkish patients.

METHODS: Age, preoperative total prostate specific antigen (PSA) values, clinical stages, total number of cores taken in biopsy, number of positive cores, preoperative biopsy Gleason score (GS), follow-up time and presence of BCR after RP were recorded. BCR was defined as a total PSA value > 0.2 ng / dl twice consecutively after RP. Classifications or scoring was performed according to pre-operative models. The 1, 3 and 5 year (yr) BCR-free rates of the patients were determined for each model. Also the accuracy of four predictive models for predicting 1, 3 and 5-yr BCR was evaluated.

RESULTS: For all pre-operative models there was statistically significant difference between risk groups in BCR free rates at 1, 3 and 5-yr after RP (p<0.001). The Harrell’s concordance index for 1-yr BCR predictions was 0,802, 0,831, 0,773 and 0,745 for the GP score, PRIX, CAPRA and D’Amico and respectively. For 3-yr BCR predictions it was 0,798, 0,791, 0,723 and 0,714 for the GP score, PRIX, CAPRA and D’Amico and respectively. Finally, The Harrell’s concordance index for 5-yr BCR predictions was 0,778, 0,771, 0,702 and 0,693 for the GP score, PRIX, CAPRA and D’Amico and respectively.

CONCLUSION: In prediction of BCR, accuracy of GP scoring and PRIX seems slightly higher than CAPRA and D’Amico risk classification. Surely our results should be supported by head to head comparisons with in other larger cohorts.

PMID:34331823 | DOI:10.1111/ijcp.14682

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Benzodiazepine high-doses: The need for an accurate definition

Int J Methods Psychiatr Res. 2021 Jul 31:e1888. doi: 10.1002/mpr.1888. Online ahead of print.

ABSTRACT

OBJECTIVES: A clear definition of what we understand of high-dose misuse or of a ‘markedly increased dose’ (as stated by the DSM-5) is important and past definitions may be inadequate. The aim of this review is to describe the different definitions used and to test these definitions for their accuracy.

METHODS: A narrative PubMed literature review was conducted based on articles published between 1 January 1990 and 31 December 2020 describing benzodiazepines (in MeSH Terms or MeSH Major Topic) and high-dose (or high-dosage). Specific definitions were applied to a population sample to show how definitions affect high-dose benzodiazepine prevalence.

RESULTS: Multiples of an equivalent-diazepam dose or of the World Health Organization ‘defined daily dosage’ were used more frequently than the overstep of the recommended maximum therapeutic dosage as a cut-off point.

CONCLUSION: High-dose use is rare but the prevalence in the general population varies among studies, mainly due to different definitions, making both clinical and epidemiological comparisons between studies difficult. Defining a high-dose user as a person who takes at least a higher dose than the maximum usual therapeutic dose over a defined period of time therefore appears to be clinically more consistent.

PMID:34331787 | DOI:10.1002/mpr.1888

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Concordance Between a Mohs Surgeon and a Dermatopathologist in Evaluating Mohs Cryosections

J Eur Acad Dermatol Venereol. 2021 Jul 31. doi: 10.1111/jdv.17574. Online ahead of print.

ABSTRACT

BACKGROUND: Mohs micrographic surgery is the gold standard treatment for high-risk non-melanoma skin cancers. The success of Mohs relies on accurate histopathologic evaluation. Due to law restrictions in some European countries Mohs surgeons are not permitted to report on histopathology, therefore a pathologist evaluates the frozen sections.

OBJECTIVE: To retrospectively assess the concordance between the certified Mohs surgeon and the pathologist in evaluating the Mohs slides that were intraoperatively evaluated by the pathologist.

MATERIALS AND METHODS: Frozen section slides of a total of 237 Mohs cases between 2013-2020 were examined by the blinded Mohs surgeon and the tumors were marked on copy maps. The copy maps and the original maps were compared and the non-concordant cases were reevaluated together by the Mohs surgeon and the dermatopathologist. The concordance rate was calculated and the inter-rater agreement was statistically analyzed using Cohen’s Kappa coefficient.

RESULTS: We report high concordance rate (97.9%) and inter-rater agreement (0.96) of Mohs surgeon and dermatopathologist in evaluating Mohs slides.

CONCLUSION: As a newly settled center, our results are in alignment with experienced centers where the Mohs surgeon evaluates the slides herself and performs the surgery.

PMID:34331818 | DOI:10.1111/jdv.17574

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Osteopathic Manual Treatment Compared to Kaltenborn-Evjenth Orthopedic Manual Therapy for Chronic Low Back Pain: A Randomized Study

Altern Ther Health Med. 2021 Jul 31:AT6593. Online ahead of print.

ABSTRACT

CONTEXT: Low back pain (LBP) is a painful pathology causing pain and disability despite treatment with the best evidence-based therapies. Osteopathic manual therapy (OMT) and Kaltenborn-Evjenth orthopedic manual therapy (KEOMT) are alternative treatments for LBP.

OBJECTIVE: The study intended to evaluate the efficacy of OMT compared to that of KEOMT for patients with chronic LBP.

DESIGN: The research team designed a randomized study.

SETTING: The study was held at the Medita Health Center in Warsaw, Poland.

PARTICIPANTS: The study included 68 participants of both genders, aged 30 to 60, with chronic LBP.

INTERVENTION: Participants were randomly assigned to one of two parallel groups, each with 34 members. The OMT group received, as a direct technique, a high-velocity/low-amplitude (HVLA) impulse, and as indirect techniques, strain counterstrain (SCS), myofascial release (MFR), and visceral mobilization therapy (VMT). The KEOMT group received lumbar segmental traction and lumbar segmental mobilization-flexion and gliding therapy grade 3. The participants in both groups received 10 treatments, two per week for five weeks.

OUTCOME MEASURES: The primary outcome was pain severity, using a numeric pain rating scale (NPRS). The secondary outcome was measurement of functional disability, using the Oswestry Disability Index (ODI).

RESULTS: The OMT and KEOMT both decreased pain and disability; however, the changes on the NPRS and ODI postintervention were statistically greater for the OMT group compared to the KEOMT group (P < .05).

CONCLUSIONS: OMT was better at reducing pain and improving quality of life. It reduced functional disability more than KEOMT in patients with chronic LBP.

PMID:34331755

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Early detection of duodenal cancer by upper GI-endoscopy in Lynch syndrome

Int J Cancer. 2021 Jul 31. doi: 10.1002/ijc.33753. Online ahead of print.

ABSTRACT

Small bowel cancer (SBC) is the malignancy with the highest standardized incidence ratio in Lynch syndrome (LS) patients. Of all SBCs, about 50% are duodenal cancers (DC), therefore being accessible by esophago-gastro-duodenoscopy (EGD) for surveillance. We asked whether early detection of DC is possible for LS patients undergoing surveillance by EGD and if surveillance should be limited to specific subgroups. Data for LS patients with DC were retrieved from the registry of the German Consortium for Familial Intestinal Cancer. Patients undergoing active surveillance by EGDs (surveillance-group) were compared to those who did not (non-surveillance-group) regarding tumor stage at diagnosis. UICC stages I-IIA were defined as early stage disease and IIB-IV as advanced stage disease. Statistical analysis was performed using Fisher’s exact test. Among 2015 patients with pathogenic variants in any mismatch-repair-gene, 47 patients with 49 DCs were identified. In 10% of cases, patients were under 35 years at diagnosis; family and personal tumor history did not correlate with DC diagnosis. Pathogenic germline variants in MSH6, PMS2 or EPCAM were present in 10% of patients. Statistical analysis could be performed on 13 DC patients in the surveillance-group and 14 in the non-surveillance-group. Early detection was possible for 71% of patients in the surveillance-group and 29% of patients in the non-surveillance-group (P = 0.021). Early detection of DC by EGD in LS patients is feasible regardless of family history, mutational status and should start no later than 25 years of age.

PMID:34331771 | DOI:10.1002/ijc.33753