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Nevin Manimala Statistics

Protocol for a quasi-experimental, 950 county study examining implementation outcomes and mechanisms of Stepping Up, a national policy effort to improve mental health and substance use services for justice-involved individuals

Implement Sci. 2021 Mar 29;16(1):31. doi: 10.1186/s13012-021-01095-2.

ABSTRACT

BACKGROUND: The criminal justice system is the largest provider of mental health services in the USA. Many jurisdictions are interested in reducing the use of the justice system for mental health problems. The national Stepping Up Initiative helps agencies within counties work together more effectively to reduce the number of individuals with mental illness in jails and to improve access to mental health services in the community. This study will compare Stepping Up counties to matched comparison counties over time to (1) examine the effectiveness of Stepping Up and (2) test hypothesized implementation mechanisms to inform multi-agency implementation efforts more broadly.

METHODS: The study will survey 950 counties at baseline, 18 months, and 36 months in a quasi-experimental design comparing implementation mechanisms and outcomes between 475 Stepping Up counties and 475 matched comparison counties. Surveys will be sent to up to four respondents per county including administrators of jail, probation, community mental health services, and community substance use treatment services (3800 total respondents). We will examine whether Stepping Up counties show faster improvements in implementation outcomes (number of justice-involved clients receiving behavioral health services, number of behavioral health evidence-based practices and policies [EBPPs] available to justice-involved individuals, and resources for behavioral health EBPP for justice-involved individuals) than do matched comparison counties. We will also evaluate whether engagement of hypothesized mechanisms explains differences in implementation outcomes. Implementation target mechanisms include (1) use of and capacity for performance monitoring, (2) use and functioning of interagency teams, (3) common goals and mission across agencies, and (4) system integration (i.e., building an integrated system of care rather than adding one program or training). Finally, we will characterize implementation processes and critical incidents using survey responses and qualitative interviews.

DISCUSSION: There are few rigorous, prospective studies examining implementation mechanisms and their relationship with behavioral health implementation outcomes in justice and associated community behavioral health settings. There is also limited understanding of implementation mechanisms that occur across systems with multiple goals. This study will describe implementation outcomes of Stepping Up and will elucidate target mechanisms that are effective in multi-goal, multi-agency systems.

PMID:33781294 | DOI:10.1186/s13012-021-01095-2

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Nevin Manimala Statistics

Determining risk factors of continuous renal replacement treatment after emergency surgery for type A acute aortic dissection: statistical issues

J Cardiothorac Surg. 2021 Mar 29;16(1):59. doi: 10.1186/s13019-021-01396-z.

ABSTRACT

This letter to the editor has made several comments regarding possible statistical issues in recent article by Wang et al. determining the risk factors of continuous renal replacement treatment after emergency surgery for type A acute aortic dissection, which is published in Journal of Cardiothoracic Surgery. 2020; 15(1):100. Our comments were involved in the issues of using the propensity score matched cohorts to adjust the covariates that can potentially confound the primary outcomes, process of establishing multivariate model and application of Kaplan-Meier curve analysis in this retrospective study. We would like to remind readers to pay special attention to these issues and invite the authors to comment on these.

PMID:33781312 | DOI:10.1186/s13019-021-01396-z

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Safety and Efficacy of High-Powered Holmium Laser Enucleation of the Prostate within 1-3 Weeks Following Prostate Biopsy

Urol Int. 2021 Mar 29:1-6. doi: 10.1159/000514422. Online ahead of print.

ABSTRACT

PURPOSE: We aim to document the feasibility, perioperative safety, and the 12-month efficacy of holmium laser enucleation of the prostate (HoLEP) within 1-3 weeks following transrectal ultrasound (TRUS)-guided prostate biopsy.

METHODS: Data of the patients who underwent HoLEP following TRUS-guided prostate biopsy between March 2017 and July 2020 were analyzed retrospectively. Patients were divided into 2 groups: group 1 had undergone HoLEP in the early period after TRUS-guided prostate biopsy, while group 2 patients were biopsy-naive (“control group”). All patients were assessed preoperatively by a physical examination with the digital rectal examination; time from biopsy to HoLEP; measurement of Qmax, postvoiding residual volume, and prostate volume by transabdominal ultrasonography; serum prostate-specific antigen level, the International Prostate Symptom Score (IPSS); the International Index of Erectile Function-5 questionnaire; and urine analysis. The patients were reevaluated at 3- and 12-month follow-up. Perioperative and postoperative complications were documented according to the modified Clavien-Dindo System.

RESULTS: Group 1 comprised 66 patients with a mean age of 67.3 ± 6.7 (range, 53-86) years, and group 2 comprised 114 patients with a mean age of 69.4 ± 9.4 (range, 36-95) years. The operation, enucleation, and morcellation efficiencies were not statistically significant between the groups. Preoperative Qmax and IPSS values were significantly improved after HoLEP surgery in the 3rd and 12th months in all patients. Our complication rates were similar in both groups.

CONCLUSION: High-powered HoLEP using 140 W energy within 1-3 weeks following TRUS-guided prostate biopsy is a feasible procedure with high enucleation efficiency, low perioperative morbidity, and excellent functional outcomes. A recent TRUS-guided prostate biopsy is not a contraindication to HoLEP.

PMID:33780959 | DOI:10.1159/000514422

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Effect of aromatherapy massage with orange essential oil on postoperative pain after cesarean section: a randomized controlled trial

J Complement Integr Med. 2021 Mar 29. doi: 10.1515/jcim-2020-0138. Online ahead of print.

ABSTRACT

OBJECTIVES: Many women in recent years have been willing to undergo puncture surgery for childbirth, which, like other surgeries, has physical and psychological side effects such as incision, infertility, chronic pain, and anxiety. Therefore, it is important to reduce and improve these side effects. The aim of this study was to determine the effect of foot massage with orange essential oil on pain and anxiety in women undergoing cesarean section.

METHODS: This randomized clinical trial study was conducted in 2019 on 80 women referred to Bahar Shahroud Hospital after cesarean section surgery. The samples were divided into two groups by intervention (foot massage with orange essential oil) and control (foot massage without orange essential oil). The Spielberger scale was used to determine anxiety scores after cesarean section. In the intervention group, the feet were massaged with orange essential oil, and in the control group, the orange essential oil massage was performed without oil. Anxiety before, immediately after, and 60 min after the intervention was measured and evaluated in both groups. Data analysis was performed using descriptive and inferential statistics. Significant levels were considered for all statistical tests (p<0.05).

RESULTS: The anxiety score before the intervention in the two groups of intervention and control was 57.12 ± 3.12 and 57.07 ± 3.54, respectively, which were not significantly different, but immediately after the intervention, the anxiety scores in both groups decreased significantly so that there was a further decrease in the intervention group (52.10 ± 4.75 and 56.02 ± 3.77), 1 h after the intervention, the anxiety score in the intervention group decreased compared to the previous stage and increased in the control group (50.40 ± 3.74 and 56.85 ± 4.27).

CONCLUSIONS: Foot massage with orange essential oil can probably be effective as a proper nursing intervention in reducing anxiety after cesarean section surgery.

PMID:33781003 | DOI:10.1515/jcim-2020-0138

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Effect of short-term and long-term traffic noise exposure on the thyroid gland in adult rats: a sexual dimorphic study

Horm Mol Biol Clin Investig. 2020 Dec 14;42(1):29-35. doi: 10.1515/hmbci-2020-0029.

ABSTRACT

OBJECTIVES: Traffic noise, as one of the noise types, is a widespread feature of the urban environments. Traffic noise exposure can lead to hearing loss, hypertension, obesity and ischemic heart diseases. Thyroid hormones involved in the physiological and pathological conditions of the body. Therefore, this study was designed to aim the evaluation of traffic noise effects on thyroid hormones secretion and thyroid tissue structure.

METHODS: Seventy two males and females wistar rats were used in this study. After one week adaptation, they divided randomly into 12 groups; the control, short term (one day) and long term (one, two, three and four weeks) groups. Traffic sound was recorded, adjusted and played (86 dB) for animals. Female rats’ cycle estrus was matched. At the end of experiment, the animals were anesthetized and cardiac blood sample was drawn. Thyroid tissue was then removed. Levels of the T3, T4, TSH, corticosterone and H&E staining were measured. p<0.05 considered to be statistically significant.

RESULTS: Findings showed that in the one-day group, T3 levels increased and T3 levels decreased in the long term groups (p<0.05). In the same way, concentration of TSH decreased in the one day, while they increased in the one, two, three and four weeks’ groups (p<0.05). Histopathological evaluations showed that in the female and male animals, long-term traffic noise increased the full follicles and decreased empty follicles (p<0.05).

CONCLUSIONS: This study revealed that traffic noise exposure led to increase of T3 plasma concentration and decrement of TSH level, although in the long term, they return to basal status. It may be due to adaptation to traffic noise.

PMID:33781004 | DOI:10.1515/hmbci-2020-0029

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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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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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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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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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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