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Nevin Manimala Statistics

Elective Fetal Reduction in Dichorionic Diamniotic Twin Pregnancies on Parental Request: A Single-Centre Experience

Fetal Diagn Ther. 2021 Mar 29:1-7. doi: 10.1159/000513581. Online ahead of print.

ABSTRACT

OBJECTIVES: Our study aimed to examine a subset of electively reduced twins and compare their outcomes with those of expectantly managed twins, along with a cohort of singleton pregnancies. The secondary aim was to ascertain the procedure-related miscarriage risks.

METHODS: A retrospective cohort analysis was performed at Apollo Centre for Fetal Medicine, New Delhi, comparing pregnancy outcomes in dichorionic diamniotic twin pregnancies which were reduced to singletons (group 1) with that of women with dichorionic twins managed expectantly (group 0) and women with a singleton pregnancy (group 2). Comparison of continuous and categorical variables was conducted using standard statistical tests.

RESULTS: We analysed 35 twins which were reduced to singletons, 421 expectantly managed dichorionic twins and 1915 women with a singleton pregnancy. In the reduction group, the rate of procedure related pregnancy loss<24 weeks was lower, compared to the expectantly managed twins, although the difference was not statistically significant (5.71% [2/35] vs. 7.13% [30/421]; p = 1.000). The median gestational age at delivery was significantly higher in reduced twins compared to expectantly managed twin pregnancies (38.0 vs. 35.4 weeks respectively, p < 0.001) with a higher mean birth weight at delivery, both of which were comparable to that among the singleton pregnancies (38.3 weeks). The rates of preterm birth <32 weeks and <34 weeks in the expectantly managed twins were significantly higher at 19.8% (66/334) and 25.7% (86/334) compared to the reduced twins, all of whom delivered beyond 34 weeks. The rates of preterm births <32 weeks, <34 weeks, and the late preterm births in the reduced twins were comparable to those in the singleton cohort.

CONCLUSIONS: The obstetric and perinatal outcomes after reduction of a dichorionic twin are better than an expectantly managed twin without an associated increase in pregnancy loss rates. Fetal reduction of dichorionic twin to a singleton appears to be a safe procedure in expert hands.

PMID:33780944 | DOI:10.1159/000513581

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Dysfunctional coping mediates the relationship between stress and mental health in health care staff working amid COVID-19 pandemic

Med Princ Pract. 2021 Mar 29. doi: 10.1159/000516181. Online ahead of print.

ABSTRACT

OBJECTIVE: The cross-sectional study aimed to assess the stress outcomes in health care staff working during the Covid-19 pandemic and to explore the role of coping in the relationship between stress outcomes and mental health dimensions with Preacher & Hayes’s mediation analysis.

SUBJECTS AND METHODS: 170 participants including physicians (n=41; 24.1%), nurses (n=114, 67.1%) and paramedics (n = 15, 8.8%) with a mean age of 37.69 ± 12,23 years and an average seniority of 14.40 ±12.32 years. were administered The Toronto Alexithymia Scale- 20 (TAS – 20), Cohen’s Perceived Stress Scale (PSS-10), the Emotional Processing Scale (EPS) and Positive and Negative Affect Schedule (PANAS). The data were analyzed by estimation of simple correlation coefficients and a Preacher and Hayes’s mediation procedure.

RESULTS: Participants reported elevated levels of stress (7-8 sten on the sten scale developed for the PSS-10 questionnaire). Statistically significant differences in the stress levels between nurses, paramedics and physicians could not determined. In contrast, significant association between mental health outcomes and occupational category could not be found. Coping mediated the relationship between coping strategies and mental health outcomes. A positive and significant relationship was observed between stress, dysfunctional coping strategies and mental health.

CONCLUSION: Our observations support the assumption about a controlling role of coping in the relationship between work-related stress and mental health outcomes in the medical staff working amid pandemic.

PMID:33780942 | DOI:10.1159/000516181

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Early Coaching to Increase Water Intake in CKD

Ann Nutr Metab. 2021 Mar 29. doi: 10.1159/000515276. Online ahead of print.

ABSTRACT

INTRODUCTION: In observational studies, increased water intake improves kidney function but not in adults with CKD stage 3 and more. CKD WIT trial has shown a nonsignificant gradual decline in kidney function after 1 year of coaching to increase water intake (CIWI) [<xref ref-type=”bibr” rid=”ref1″>1</xref>]. We propose that CIWI may benefit in CKD stage 1-2 (G1 and G2) and depends on functional renal functional reserve (RFR) [<xref ref-type=”bibr” rid=”ref2″>2</xref>, <xref ref-type=”bibr” rid=”ref3″>3</xref>].

OBJECTIVE: Parallel-group randomized trial was aimed to determinate the effectiveness of CIWI dependence of estimated glomerular filtration rate (eGFR) stage and RFR in adults with CKD 1-2 stages.

METHODS: CKD WIT trial was taken as the basis for prospective multicenter randomized trial named “Early Coaching to Increase Water Intake in CKD (ECIWIC).” The primary outcome was the change in kidney function by eGFR from baseline to 12 months. Secondary outcomes included 1-year change in urine albumin/Cr ratio, and patient-reported overall quality of health (QH) ranged from 0 (worst possible) to 10 (best possible). CIWI aimed to have the diuresis being 1.7-2 L. There were 4 groups with nondiet sodium restriction which consisted of 31 patients each: 2 groups with CKD G1 and CKD G2, undergoing CIWI and 2 others with CKD G1 and CKD G2 without CIWI (Fig. 1a). Overall checks were made at 0, 6, and 12 months. RFR evaluation was performed using 0.45% sodium chloride oral solution.

RESULTS: Of our randomized 124 patients (mean age 53.2 years; men 83 [67%], 0 died), mean change in 24-h urine volume was 0.6 L per day in G1 with CIWI group and 0.5 L in G2. No statistically significant data on eGFR depending CIWI were obtained (Fig. <xref ref-type=”fig” rid=”f01″>1</xref>b). However, the trend suggests that CIWI improves eGFR in CKD G1 (from 95 to 96 mL/min/1.73 m2) and preserves eGFR decline in CKD G2 (78-78). The QH values were also preserved (from 7 to 7 in G1 and G2 groups). Although coaching to maintain the same water intake did not preserve physiological and pathological eGFR decreasing in CKD G1-2 (G1 from 96 to 93, G2 from 76 to 73; t = 0.6, p = 0.29, and p ≤ 0.05 in all groups) and the QH was declined (from 7 to 6 in both groups). An individual analysis of the RFR has shown that patients with RFR more than 50% (G1 19 patients, 61%, and G2 13 patients, 42%) had reliable preservation of eGFR with its increase of 1.5 mL/min on CIWI, while patients with low functional renal reserve had a drop of eGFR at 1.1 mL/min/m2 within 12 months. Patients with low normal serum sodium levels have shown worse results on CIWI.

CONCLUSIONS: With CKD G1, the CIWI leads to the preservation of the renal function with its increase of GFR per 1 mL/min/m2/per year in comparison with the same water intake. In CKD G2, the CIWI prevents physiological and pathological loss of renal function, and RFR above 50% aids restoration of eGFR both in CKD G1-2. ECIWIC trial demonstrates benefit of CIWI in patients with CKD 1-2 and preserved RFR.

PMID:33780940 | DOI:10.1159/000515276

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EVALUATION AND VALIDATION OF A NEW SCORE TO MEASURE THE SEVERITY OF SMALL-BOWEL ANGIODYSPLASIA ON VIDEO CAPSULE ENDOSCOPY (CESBAI)

Dig Dis. 2021 Mar 29. doi: 10.1159/000516163. Online ahead of print.

ABSTRACT

INTRODUCTION: Angiodysplasias are responsible of 50 % of small bowel bleeding. An endoscopic method that allows measuring its severity is not available Aims: to validate a new endoscopic score with VCE to measure the severity of small bowel angiodysplasias (SBAD).

METHODS: Four endoscopists independently reviewed VCE videos of 22 patients with SBAD. The score graded three variables: A. Extent of lesions: E1: located in one half of the intestine and E2:in both halves. B. Number of lesions: N1 <5; N2: 5-10 and N3: >10 lesions. C. Probability of bleeding: P1: pale red spots; P2: bright red spots; P3: bleeding stigmata and P4: active bleeding. CESBAI was calculated as follows: E x 1 + N x 2 + P x 3. Interobserver variability was analyzed by the Spearman’s correlation and agreement Kappa statistic tests.

RESULTS: The mean CESBAI scores by observers (O) were: O1= 11.6 ± 4.1; O2 =: 11.3 ± 4.8; O3 = 11.1 ± 4.9 and O 4 = 11.8 ± 4.2 (p>0.05). Spearman’s correlation values of CESBAI between every two observers were from 0.61 to 0.94 ( p <0.001) with a global correlation of 0.73 among all observers. Kappa values of CESBAI between every two observers ranged from 0.42 to 0.87 (p<0.001) with global agreement of 0.57 among all observers. All evaluators stated that the method was easy to use.

CONCLUSIONS: CESBAI is a reliable and reproducible score. Nevertheless, these results must be validated in other studies with larger population before assessing its power for predicting bleeding recurrence.

PMID:33780938 | DOI:10.1159/000516163

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Use of Composite Outcomes in Neonatal Trials: An Analysis of the Cochrane Reviews

Neonatology. 2021 Mar 29:1-5. doi: 10.1159/000514402. Online ahead of print.

ABSTRACT

INTRODUCTION: Composite outcomes are used to increase the power of a study by combining event rates. Many composite outcomes in adult clinical trials have components that differ substantially in patient importance, event rate, and effect size, making interpretation challenging. Little is known about the use of composite outcomes in neonatal randomized controlled trials (RCTs).

METHODS: We assessed the use of composite outcomes in neonatal RCTs included in Cochrane Neonatal reviews published till November 2017. Two authors reviewed the components of the composite outcomes to compare their patient importance and computed the ratios of effect sizes and event rates between the components, with an a priori threshold of 1.5, indicating a substantial difference. Descriptive statistics were presented.

RESULTS: We extracted 7,766 outcomes in 2,134 RCTs in 312 systematic reviews. Among them, 55 composite outcomes (0.7%) were identified in 46 RCTs. The vast majority (92.7%) of composite outcomes had 2 components, with death being the most common component (included 51 times [92.7%]). The components in nearly three-quarters of the composite outcomes (n = 40 [72.7%]) had different patient importance, while the effect sizes and event rates differed substantially between the components in 27 (49.1%) and 35 (63.6%) outcomes, respectively, with up to 43-fold difference in the event rates observed.

CONCLUSIONS: The majority of composite outcomes in neonatal RCTs had different patient importance with contrasting effect sizes and event rates between the components. In patient communication, clinicians should highlight individual components, rather than the composites, with explanation on the relationship between the components, to avoid misleading impression on the effect of the intervention. Future trials should report the estimates of all individual components alongside the composite outcomes presented.

PMID:33780936 | DOI:10.1159/000514402

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The Relationship between %BML, Urine Color, Thirst Level and Urine Indices of Hydration Status

Ann Nutr Metab. 2021 Mar 29. doi: 10.1159/000515217. Online ahead of print.

ABSTRACT

INTRODUCTION: Dehydration is known to impair health, quality of daily life, and exercise performance [<xref ref-type=”bibr” rid=”ref1″>1</xref>]. While several methods are utilized to assess fluid balance, there is no gold standard to assess hydration status [<xref ref-type=”bibr” rid=”ref2″>2</xref>]. Cheuvront and Kenefick [<xref ref-type=”bibr” rid=”ref3″>3</xref>] suggested the use of a Venn diagram, which consists of % body mass weight (BML), urine color, and thirst level (WUT) to measure hydration status and fluid needs. However, no study to date has examined the relationship between the WUT criteria and hydration status measured by urine indices.

OBJECTIVE: The purpose of this study was to investigate the relationships between urine-specific gravity (USG), urine osmolality (UOSM), and the WUT criteria.

METHODS: Twenty-two females (mean ± SD; age, 20 ± 1 year; weight, 65.4 ± 12.6 kg) and twenty-one males (age, 21 ± 1 year; body mass, 78.7 ± 14.6 kg) participated in this study. First-morning body mass, urine color, USG, UOSM, and thirst level were collected for 10 consecutive days. First 3 days were utilized to establish a euhydrated baseline body weight. %BML >1%, urine color >5, and thirst level ≥5 were used as the dehydration thresholds. The number of markers that indicated dehydration levels was summed when each variable met each threshold. One-way ANOVA with Tukey pairwise comparison was used to assess the differences in USG and UOSM, followed by a calculation of effect size (ES).

RESULTS: Figure <xref ref-type=”fig” rid=”f01″>1</xref> indicates the differences of UOSM based on the WUT criteria. For UOSM, “2 markers indicated” (mean [M] ± SD [ES], 705 ± 253 mOsmol [0.43], p = 0.018) was significantly higher than “1 marker indicated” (M ± SD, 597 ± 253 mOsmol). Additionally, “zero marker indicated” (509 ± 249 mOsmol) was significantly lower than “3 markers indicated” (M ± SD [ES], 761 ± 250 mOsmol, [1.01], p = 0.02) and “2 markers indicated” ([ES], [0.78], p = 0.004). However, there was no statistical difference between “3 markers indicated” ([ES], [0.65], p = 0.13) and “1 marker indicated.” For USG, “3 markers indicated” (M ± SD [ES], 1.021 ± 0.007 [0.57], p = 0.025) and “2 markers indicated” (M ± SD [ES], 1.019 ± 0.010 [0.31], p = 0.026) were significantly higher than “1 marker indicated” (M ± SD, 1.016 ± 0.009). Additionally, “zero marker indicated” (1.014 ± 0.005) was significantly lower than “3 markers indicated” ([ES], [1.21], p = 0.005) and “2 markers indicated” ([ES], [0.54], p = 0.009).

CONCLUSION: When 3 markers indicated dehydration levels, UOSM and USG were greater than euhydrated cut points. When 2 markers indicated dehydration levels, USG was higher than the euhydrated cut point. Additionally, UOSM and USG were significantly lower when zero or 1 marker indicated dehydration levels. Thus, the WUT criteria are a useful tool to assess hydration status. Athletes, coaches, sports scientists, and medical professions can use this strategy in the field settings to optimize their performance and health without consuming money and time.

PMID:33780927 | DOI:10.1159/000515217

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Clinical predictors of cardiac toxicity in HER2-positive early breast cancer patients treated with adjuvant s.c. versus i.v. trastuzumab

Breast. 2021 Mar 17;57:80-85. doi: 10.1016/j.breast.2021.03.004. Online ahead of print.

ABSTRACT

BACKGROUND: Few data are available about real-life cardiotoxicity associated with s.c. versus i.v. trastuzumab treatment of early-stage, HER2-positive breast cancer, and little is known about its predisposing factors.

PATIENTS AND METHODS: We retrospectively reviewed data of 363 adult patients treated with adjuvant trastuzumab for HER2-positive breast cancer. Univariate statistical analysis was performed, and a multivariable logistic model was developed to identify independent risk factors of cardiac toxicity.

RESULTS: Within 5 years, the overall incidence of events meeting our criteria was 11.8%, and an early discontinuation of trastuzumab was recorded in 20 patients (5.5%). No cases of congestive heart failure occurred, neither multiple events per patient were observed. A total of 184 patients received i.v. and 179 received s.c. trastuzumab. Compared with the s.c. formulation, a higher cardiotoxicity rate for the i.v. administration (15.2% vs 8.4%) was found, and particularly in those patients with cardiovascular risk factors (19.3% vs 8.7%), at the univariate and multivariate analyses. Although more patients with prior anthracycline-based chemotherapy experienced cardiac events, the association of this therapy with cardiac events was not significant. The incidence of cardiac events was not influenced by anthropometric data (e.g. body mass index) or a diagnosis of diabetes mellitus. 5-year event-free survival was 91.7% in the overall population; event-free survival rates were similar between the s.c. and the i.v. groups.

CONCLUSION: Our study shows a more favorable safety profile of s.c. versus i.v trastuzumab administration. The use of s.c. trastuzumab could be advisable in at-risk patients.

PMID:33780903 | DOI:10.1016/j.breast.2021.03.004

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Characteristics of healthy behavior in Mexican women who survived breast cancer

Complement Ther Clin Pract. 2021 Mar 6;43:101355. doi: 10.1016/j.ctcp.2021.101355. Online ahead of print.

ABSTRACT

OBJECTIVE: This paper aims to assess diet and lifestyle by designing a healthy behavior index (HBI) related to the educational level and time of breast cancer (BC) diagnosis.

METHODS: 241 female breast cancer survivors treated at Centro Estatal de Cancerología (State Cancer Center) in Mexico were assessed based on dietary pattern, physical activity, smoking, alcohol consumption, body size and shape, sleep disorders with increasing scores that represent less healthy characteristics. The odds ratios (OR) and quartiles of the healthy behavior index and the time of diagnosis were estimated. The regression model was used to assess the association between HBI and the BC covariates.

RESULTS: The healthy behavior index for the two first quartiles was that of p < 0.001. The graphic behavior of correspondence with the covariates (age, schooling and moderate physical activity) showed a different three-dimensional effect on healthy behaviors. According to diagnosis time ≤ three years, the following covariates were significant: socioeconomic status, (OR: 4.34 CI 95% 1.2-9.5), sleep disturbances (p = 020) and protective intake of fruits and vegetables (p = 0.001). In the multivariate analysis, survivors with a high level of education are significantly more likely to show a healthy behavior (OR: 0.3 95% CI 0.12 – 0.8); as well as the early clinical stages (OR: 0.4 95% CI 0.2-0.9).

CONCLUSION: In breast cancer survivors, both the high level of education and early clinical stages were important healthy behavior modifiers.

PRACTICE IMPLICATIONS: Since diets are potentially modifiable, the findings may have further implications to promote a careful dietary pattern to prevent breast cancer. These variables should be assessed as a strategy in cancer survivor preventive programs.

PMID:33780875 | DOI:10.1016/j.ctcp.2021.101355

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Automatic spinal cord segmentation from axial-view MRI slices using CNN with grayscale regularized active contour propagation

Comput Biol Med. 2021 Mar 18;132:104345. doi: 10.1016/j.compbiomed.2021.104345. Online ahead of print.

ABSTRACT

Accurate positioning of the responsible segment for patients with cervical spondylotic myelopathy (CSM) is clinically important not only to the surgery but also to reduce the incidence of surgical trauma and complications. Spinal cord segmentation is a crucial step in the positioning procedure. This study proposed a fully automated approach for spinal cord segmentation from 2D axial-view MRI slices of patients with CSM. The proposed method was trained and tested using clinical data from 20 CSM patients (359 images) acquired by the Peking University Third Hospital, with ground truth labeled by professional radiologists. The accuracy of the proposed method was evaluated using quantitative measures, the reliability metric as well as visual assessment. The proposed method yielded a Dice coefficient of 87.0%, Hausdorff distance of 9.7 mm, root-mean-square error of 5.9 mm. Higher conformance with ground truth was observed for the proposed method in comparison to the state-of-the-art algorithms. The results are also statistically significant with p-values calculated between state-of-the-art methods and the proposed methods.

PMID:33780869 | DOI:10.1016/j.compbiomed.2021.104345

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Comparative effectiveness of psychotherapy approaches on Death Anxiety in Multiple Sclerosis Patients. A pilot randomized controlled trial

Mult Scler Relat Disord. 2021 Mar 19;51:102914. doi: 10.1016/j.msard.2021.102914. Online ahead of print.

ABSTRACT

BACKGROUND: Death anxiety (DA) in chronic diseases has occupied the human mind more than other diseases. Therefore, multiple sclerosis (MS) patients are more prone to DA due to recurrence periods.

OBJECTIVE: Among the psychological interventions the two approaches of logotherapy (LT) and acceptance and commitment therapy (ACT), They pay more attention and concentration on the subject of suffering. Therefore, the present study aimed to compare the effectiveness of these two approaches on DA in MS patients.

METHODS: The statistical population included 48 women who were diagnosed as MS patients and had medical records at Iran MS Society in Tehran, in terms of entry and exit criteria, which were selected by convenience sampling. Then they were randomly divided into two experimental groups and one control group. This plan has an independent variable at three levels including: LT, ACT and the control group. The dependent variables are the subjects’ scores on the Death Attitude Profile-Revised (DAP-R) (Wong., Reker & Gesser, 1994). Therapeutic interventions included 12 sessions of 2 h per week. A 3-hour workshop was held for the control group. in which patients were provided with basic information about the psychological problems of MS, but no strategy was presented. In order to obtain the results, the analysis of covariance was used and in the follow-up study, repeated measures analysis of variance with an intergroup variable (mixed model) was used.

RESULTS: It showed that both LT and ACT groups were able to be effective and reduce DA in comparison with the control group and such a positive effect on the improvement of DA was evident both in the post-test and follow-up stages. However, no significant differences were observed in comparing the effectiveness of the two intervention methods, so both methods were effective in reducing DA due to the nature of suffering.

CONCLUSION: Considering the effectiveness of LT and ACT in reducing DA in MS patients, the results of this study can be used in order to achieve therapeutic goals and reduce psychological problems in chronic diseases.

PMID:33780806 | DOI:10.1016/j.msard.2021.102914