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Nevin Manimala Statistics

Role of stereotactic body radiation in the enhancement of the quality of life in locally advanced pancreatic adenocarcinoma: a systematic review

Radiat Oncol. 2022 Jun 17;17(1):108. doi: 10.1186/s13014-022-02076-5.

ABSTRACT

INTRODUCTION: Up to 30% of pancreatic cancer patients initially present locally advanced (LAPC). Stereotactic body radiation therapy (SBRT) may be an additional palliative treatment option when curative resection is no longer achievable. Our systematic review aimed to assess the effect of SBRT on the quality of life in LAPC.

METHODS: We searched five databases until June 29th, 2021, for original articles that reported on SBRT for histologically proven LAPC in adults. Data were extracted on study characteristics, SBRT and additional therapy regimen, pain, biliary complications, nutrition, quality of life and other patient-reported outcomes. Statistical analyses were performed for population and survival data.

RESULTS: 11 case series studies comprising 292 patients with a median age of 66 (range 34-89) years were included in the final analysis. The weighted average BED2;10 (radiation biologically effective dose, equivalent dose in 2 Gy fractions) was 54 Gy, delivered in 3 to 6 fractions. The individual studies used different scales and endpoints, not allowing a meta-analysis. Pain generally appeared to be improved by SBRT. SBRT significantly reduced jaundice. Local control was achieved in 71.7% of patients. Weight loss and nausea also tended to improve after SBRT.

CONCLUSION: SBRT of locally advanced irresectable pancreatic cancer is a promising approach for achieving local control and improving the quality of life. However, randomized controlled trials with larger cohorts are needed to assess the value of SBRT in pancreatic cancer therapy.

PMID:35715808 | DOI:10.1186/s13014-022-02076-5

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Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial

BMC Complement Med Ther. 2022 Jun 17;22(1):161. doi: 10.1186/s12906-022-03648-4.

ABSTRACT

BACKGROUND: In 2019, investigators from China, South Korea and the United States of America initiated a coordinated multinational trial. The trial included three parallel randomized studies with a planned pooled analysis of individual patient data, to test the effectiveness of acupuncture on hot flash-related symptoms in hormone receptor-positive breast cancer patients prescribed adjuvant endocrine therapy. Given the study’s approach, there was no central coordinating center or data monitoring committee for the study, so a site performance self-monitoring toolkit was developed and implemented to support study teams in collecting and maintaining high-quality regulatory information, and consistent review of study data and documentation.

METHODS: The site performance self-monitoring toolkit was created based on best practices related to post-approval quality assurance/quality improvement (QA/QI) procedures that support data quality. The toolkit included: (1) a binder of essential study management documents and related monitoring logs for sites to complete and maintain (herein called regulator binder), (2) a study start-up checklist, (3) a self-assessment study conduct and oversight checklist to be completed regularly, and (4) a study close-out checklist. In addition, a process of regular virtual meetings to discuss documentation progress coupled with periodic external remote review of completed logs and checklists provided accountability checks.

RESULTS: Over the course of the study, the sites in China and South Korea completed the entirety of the site performance self-monitoring toolkit, and successfully submitted their completed materials for review. The process of implementing a self-monitoring toolkit in a multinational integrative medicine study is described qualitatively. Periodic external review of the completed toolkit materials revealed categories of findings. Written follow-up reports were provided to sites and discussion of the documents occurred via separate virtual meetings.

CONCLUSIONS: Site study team self-monitoring provides a feasible, consistent, and effective way to review the collection and maintenance of data and regulatory documentation for quality assessment in minimal risk clinical research studies and can augment formal study monitoring activities in higher risk studies. Iterative feedback and support appeared to drive a disciplined approach to maintaining regulatory document compliance and helped sustain investigator and study team engagement in the process.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03783546 (21/12/2018).

PMID:35715806 | DOI:10.1186/s12906-022-03648-4

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Safety and efficacy of the Seraph® 100 Microbind® Affinity Blood Filter to remove bacteria from the blood stream: results of the first in human study

Crit Care. 2022 Jun 17;26(1):181. doi: 10.1186/s13054-022-04044-7.

ABSTRACT

BACKGROUND: Bacterial burden as well as duration of bacteremia influence the outcome of patients with bloodstream infections. Promptly decreasing bacterial load in the blood by using extracorporeal devices in addition to anti-infective therapy has recently been explored. Preclinical studies with the Seraph® 100 Microbind® Affinity Blood Filter (Seraph® 100), which consists of heparin that is covalently bound to polymer beads, have demonstrated an effective binding of bacteria and viruses. Pathogens adhere to the heparin coated polymer beads in the adsorber as they would normally do to heparan sulfate on cell surfaces. Using this biomimetic principle, the Seraph® 100 could help to decrease bacterial burden in vivo.

METHODS: This first in human, prospective, multicenter, non-randomized interventional study included patients with blood culture positive bloodstream infection and the need for kidney replacement therapy as an adjunctive treatment for bloodstream infections. We performed a single four-hour hemoperfusion treatment with the Seraph® 100 in conjunction with a dialysis procedure. Post procedure follow up was 14 days.

RESULTS: Fifteen hemodialysis patients (3F/12 M, age 74.0 [68.0-78.5] years, dialysis vintage 28.0 [11.0-45.0] months) were enrolled. Seraph® 100 treatment started 66.4 [45.7-80.6] hours after the initial positive blood culture was drawn. During the treatment with the Seraph® 100 with a median blood flow of 285 [225-300] ml/min no device or treatment related adverse events were reported. Blood pressure and heart rate remained stable while peripheral oxygen saturation improved during the treatment from 98.0 [92.5-98.0] to 99.0 [98.0-99.5] %; p = 0.0184. Four patients still had positive blood culture at the start of Seraph® 100 treatment. In one patient blood cultures turned negative during treatment. The time to positivity (TTP) was increased between inflow and outflow blood cultures by 36 [- 7.2 to 96.3] minutes. However, overall TTP increase was not statistical significant.

CONCLUSIONS: Seraph® 100 treatment was well tolerated. Adding Seraph® 100 to antibiotics early in the course of bacteremia might result in a faster resolution of bloodstream infections, which has to be evaluated in further studies.

TRAIL REGISTRATION: ClinicalTrials.gov Identifier: NCT02914132 , first posted September 26, 2016.

PMID:35715801 | DOI:10.1186/s13054-022-04044-7

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The effect of a tele-educational intervention on modifying dysfunctional sexual beliefs of pregnant women: a randomized controlled trial

BMC Pregnancy Childbirth. 2022 Jun 17;22(1):495. doi: 10.1186/s12884-022-04773-1.

ABSTRACT

BACKGROUND & AIM: Some cultural scenarios in pregnancy and childbirth reinforce dysfunctional sexual beliefs that reverse changes in the couple’s sexual life. The present study aimed to investigate the effect of education by sending text messages on modifying dysfunctional sexual beliefs in pregnant women.

METHODS & MATERIALS: This study is a randomized clinical trial, and 82 eligible pregnant women referred to educational-medical centers to receive prenatal care were randomly assigned to intervention or control group. The intervention group received 24 text messages during eight weeks (three text messages per week), and the control group received only routine care. Data was collected through a demographic questionnaire, reproductive profile, Spinner’s Dyadic Adjustment Scale (DAS), and dysfunctional sexual beliefs questionnaire. Both groups completed the questionnaires before and one week after the intervention. Independent t-test, paired t-test, and analysis of covariance was used to analyze the data.

RESULTS: The findings revealed no statistically significant difference in the baseline Dyadic Adjustment mean scores of control (132.4 ± 11.01) and intervention (130.10 ± 10.66) groups. Paired t-test analysis showed that the mean score of dysfunctional sexual beliefs was significantly decreased from (29 ± 7.61) at baseline compared to one week after intervention (10.54 ± 6.97) (p < 0.001). Analysis of covariance test to compare the scores of dysfunctional sexual beliefs in the intervention group (10.54 ± 6.97) and control group (26.80 ± 7.80) showed a statistically significant difference (p < 0.01) with an effect size of 0.67.

CONCLUSION: This study showed that sending text messages to mobile phones of pregnant women has corrected their dysfunctional sexual beliefs. Therefore, this approach can be used in pregnancy care to promote women’s sexual health.

TRIAL REGISTRATION: Clinical trial registry: IRCT20161230031662N9 .

PMID:35715786 | DOI:10.1186/s12884-022-04773-1

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Spatio-temporal evolution and trend prediction of the incidence of Class B notifiable infectious diseases in China: a sample of statistical data from 2007 to 2020

BMC Public Health. 2022 Jun 17;22(1):1208. doi: 10.1186/s12889-022-13566-2.

ABSTRACT

BACKGROUND: With the accelerated global integration and the impact of climatic, ecological and social environmental changes, China will continue to face the challenge of the outbreak and spread of emerging infectious diseases and traditional ones. This study aims to explore the spatial and temporal evolutionary characteristics of the incidence of Class B notifiable infectious diseases in China from 2007 to 2020, and to forecast the trend of it as well. Hopefully, it will provide a reference for the formulation of infectious disease prevention and control strategies.

METHODS: Data on the incidence rates of Class B notifiable infectious diseases in 31 provinces, municipalities and autonomous regions of China from 2007 to 2020 were collected for the prediction of the spatio-temporal evolution and spatial correlation as well as the incidence of Class B notifiable infectious diseases in China based on global spatial autocorrelation and Autoregressive Integrated Moving Average (ARIMA).

RESULTS: From 2007 to 2020, the national incidence rate of Class B notifiable infectious diseases (from 272.37 per 100,000 in 2007 to 190.35 per 100,000 in 2020) decreases year by year, and the spatial distribution shows an “east-central-west” stepwise increase. From 2007 to 2020, the spatial clustering of the incidence of Class B notifiable infectious diseases is significant and increasing year by year (Moran’s I index values range from 0.189 to 0.332, p < 0.05). The forecasted incidence rates of Class B notifiable infectious diseases nationwide from 2021 to 2024 (205.26/100,000, 199.95/100,000, 194.74/100,000 and 189.62/100,000) as well as the forecasted values for most regions show a downward trend, with only some regions (Guangdong, Hunan, Hainan, Tibet, Guangxi and Guizhou) showing an increasing trend year by year.

CONCLUSIONS: The current study found that since there were significant regional disparities in the prevention and control of infectious diseases in China between 2007 and 2020, the reduction of the incidence of Class B notifiable infectious diseases requires the joint efforts of the surrounding provinces. Besides, special attention should be paid to provinces with an increasing trend in the incidence of Class B notifiable infectious diseases to prevent the re-emergence of certain traditional infectious diseases in a particular province or even the whole country, as well as the outbreak and spread of emerging infectious diseases.

PMID:35715790 | DOI:10.1186/s12889-022-13566-2

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Nurse preceptors’ perceptions of benefits, rewards, support, and commitment to the preceptor role in a new preceptorship program

BMC Med Educ. 2022 Jun 17;22(1):472. doi: 10.1186/s12909-022-03534-0.

ABSTRACT

BACKGROUND: Nurse preceptorship is a new concept emerging in the Iranian health care system. The purpose of this research was to assess preceptor nurses’ perceived benefits, rewards, support, and commitment to the role in a new nurse preceptorship program in Iran and to examine the relationships between these concepts.

METHODS: A descriptive correlational study was employed, and using total population sampling method, 45 preceptor nurses were recruited from a tertiary referral teaching hospital in Iran. Data were collected using the Preceptor’s Perception of Benefits and Rewards Scale, the Preceptor’s Perception of Support Scale, and the Commitment to the Preceptor Role Scale. Descriptive statistics and correlational analysis were used to analyse data.

RESULTS: Preceptors’ commitment to their role was positively and moderately associated with their perceived benefits and rewards (r = 0.503, p = 0.001) and perceived support (r = 0.430, p = 0.003). None of the examined demographic and practice variables showed statistically significant association with commitment to the preceptor role.

CONCLUSIONS: Commitment to the preceptor role was associated with benefits, rewards and support that preceptor nurses perceive in relation to their role. To optimise the effectiveness of nurse preceptorship programs, benefits, rewards, recognition, and support should be integral to planning of these programs.

PMID:35715778 | DOI:10.1186/s12909-022-03534-0

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Analysis of risk factors associated with acute respiratory infections among under-five children in Uganda

BMC Public Health. 2022 Jun 17;22(1):1209. doi: 10.1186/s12889-022-13532-y.

ABSTRACT

BACKGROUND: Globally, infectious diseases are the major cause of death in children under the age of 5 years. Sub-Saharan Africa and South Asia account for 95% of global child mortalities every year, where acute respiratory infections (ARI) remain the leading cause of child morbidity and mortality. The aim of this study is to analyze the risk factors of ARI disease symptoms among children under the age of 5 years in Uganda.

METHODS: A cross-sectional design was used to analyze 2016 Uganda Demographic and Health Survey (UDHS) data collected on 13,493 children under the age of 5 years in Uganda. Various methods, such as logistic regression, elastic net logistic regression, decision tree, and random forest, were compared and used to predict 75% of the symptom outcomes of ARI disease. Well-performing methods were used to determine potential risk factors for ARI disease symptoms among children under the age of 5 years.

RESULTS: In Uganda, about 40.3% of children were reported to have ARI disease symptoms in the 2 weeks preceding the survey. Children under the age of 24 months were found to have a high prevalence of ARI disease symptoms. By considering 75% of the sample, the random forest was found to be a well-performing method (accuracy = 88.7%; AUC = 0.951) compared to the logistic regression method (accuracy = 62.0%; AUC = 0.638) and other methods in predicting childhood ARI symptoms. In addition, one-year old children (OR: 1.27; 95% CI: 1.12-1.44), children whose mothers were teenagers (OR: 1.28; 95% CI: 1.06-1.53), and farm workers (1.25; 95% CI: 1.11-1.42) were most likely to have ARI disease symptoms than other categories. Furthermore, children aged 48-59 months (OR: 0.69; 95% CI: 0.60-0.80), breastfed children (OR: 0.83; 95% CI: 0.76-0.92), usage of charcoal in cooking (OR: 0.77; 95% CI: 0.69-0.87), and the rainy season effect (OR: 0.66; 95% CI: 0.61-0.72) showed a low risk of developing ARI disease symptoms among children under the age of 5 years in Uganda.

CONCLUSION: Policy-makers and health stakeholders should initiate target-oriented approaches to address the problem regarding poor children’s healthcare, improper environmental conditions, and childcare facilities. For the sake of early child care, the government should promote child breastfeeding and maternal education.

PMID:35715771 | DOI:10.1186/s12889-022-13532-y

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Comprehensive analysis reveals COPB2 and RYK associated with tumor stages of larynx squamous cell carcinoma

BMC Cancer. 2022 Jun 17;22(1):667. doi: 10.1186/s12885-022-09766-z.

ABSTRACT

BACKGROUND: Laryngeal squamous cell carcinoma (LSCC) is one of the highly aggressive malignancy types of head and neck squamous cell carcinomas; genes involved in the development of LSCC still need exploration.

METHODS: We downloaded expression profiles of 96 (85 in advanced stage and 11 in early stage) LSCC patients from TCGA-HNSC. Function enrichment and protein-protein interactions of genes in significant modules were conducted. Univariate and multivariate Cox regression analyses were performed to explore potential prognostic biomarkers for LSCC. The expression levels of genes at different stages were compared and visualized via boxplots. Immune infiltration was examined by the CIBERSORTx web-based tool and depicted with ggplot2. Gene set enrichment analysis (GSEA) was utilized to analyze functional enrichment terms and pathways. Immunohistochemical staining (IHC) was used to verify the expression of genes in the LSCC samples.

RESULTS: We identified 25 modules, including 3 modules significantly related to tumor stages of LSCC via weighted gene co-expression network analysis (WGCNA). UIMC1, NPM1, and DCTN4 in the module ‘cyan’, TARS in the module ‘darkorange’, and COPB2 and RYK in the module ‘lightyellow’ showed statistically significant relation to overall survival. The expression of COPB2, DCTN4, RYK, TARS, and UIMC1 indicated association with the change of fraction of immune cells in LSCC patients; two genes, COPB2 and RYK, indicated different expression in various tumor stages of LSCC. Finally, COPB2 and RYK showed high-expression in tumor tissues of advanced LSCC patients.

CONCLUSIONS: Our study provided a potential perceptive in analyzing progression of LSCC cells and exploring prognostic genes.

PMID:35715770 | DOI:10.1186/s12885-022-09766-z

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Predictors of time to recovery from postpartum hemorrhage in Debre Markos comprehensive specialized hospital, Northwest, Ethiopia, 2020/21

BMC Pregnancy Childbirth. 2022 Jun 17;22(1):498. doi: 10.1186/s12884-022-04834-5.

ABSTRACT

BACKGROUND: Postpartum hemorrhage is one of the leading causes of maternal deaths worldwide. Early recovery is a performance indicator and better health outcome of patients with postpartum hemorrhage. Therefore, this study aimed to assess time to recovery from postpartum hemorrhage and its predictors in Debre Markos Comprehensive Specialized Hospital, Ethiopia, 2020.

METHODS: A retrospective follow-up study was conducted among 302 women who were diagnosed with postpartum hemorrhage from January 1, 2016 to December 31, 2020 at Debre Markos Comprehensive Specialized Hospital. Consecutive sampling technique was employed. To show the statistical significant difference between each group of variables, log rank test was used. Kaplan Meier analysis to estimate time to recovery and cox proportional-hazard regression analysis to determine independent predictors were carried out cautiously. Adjusted hazard ratio used to determine the strength of association.

RESULT: The median recovery time from postpartum hemorrhage was 13 h with range of (10 to 17 h). Blood transfusion (AHR: 1.8, 95% CI (1.39, 2.57)), NASG utilization (AHR: 6.5, 95% CI (4.58, 9.42)) fluid resuscitation (AHR 2.9, 95% CI (1.48, 5.54)), active management of third stage of labor (AHR: 1.7, 95% CI (1.18, 2.45)) and history of antenatal care follow-up (AHR: 2.6, 95% CI (1.91, 3.56)) were the predictors, which shorten the recovery time. Comorbidities like anemia at the time of admission (AHR: 0.62 95% CI (0.44, 0.89)), retroviral infection (AHR: 0.33, 95% CI (0.16, 0.67)) and Hepatitis B-Virus infection (AHR: 0.52, 95% CI (0.32, 0.82)) delay the recovery rate from postpartum hemorrhage.

CONCLUSION: Mothers in North-West Ethiopia stays morbid from postpartum hemorrhage for more than half a day. Their recovery time was affected by Non-Pneumatic Anti-Shock Garment utilization, implementation of emergency management components like blood transfusion and fluid resuscitation, history of antenatal care follow up, and being comorbid with viral infections. Non-pneumatic anti-shock garment application to every mother with postpartum hemorrhage and implementation of proper emergency management approach are vital for rapid recovery from postpartum hemorrhage.

PMID:35715769 | DOI:10.1186/s12884-022-04834-5

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Management practice and treatment outcomes of adult patients with Lupus Nephritis at the Renal Clinic of St. Paul’s Hospital Millennium Medical College, Addis Ababa, Ethiopia

BMC Nephrol. 2022 Jun 17;23(1):214. doi: 10.1186/s12882-022-02846-z.

ABSTRACT

BACKGROUND: Lupus nephritis (LN) is the most common severe complication of systemic lupus erythematosus (SLE) which results in high morbidity and mortality. Up to 60% of adult patients with SLE develop the renal disease with different severity. Even with potent anti-inflammatory and immunosuppressive therapies, many LN patients still progress to chronic kidney disease or end-stage renal disease. Thus, this study aimed to assess the management practice, treatment outcomes and to identify the associated factors of poor renal outcome in adult LN patients at the renal clinic of St. Paul’s Hospital Millennium Medical College, Addis Ababa, Ethiopia.

METHODS: A retrospective cross-sectional study design was used to collect the data using an abstraction tool from patients’ records. The Kidney Disease Improving Global Outcomes (KDIGO) criteria were used to diagnose LN among SLE patients. Logistic regression was used to determine crude and adjusted odds ratio and a p-value of < 0.05 was considered statistically significant. Ethical approval was obtained from the ethical review committee of the School of Pharmacy, Addis Ababa University and institutional review board of St. Paul’s Hospital Millennium Medical College.

RESULTS: Out of 168 study participants enrolled from September 1, 2016 to October 30, 2020, a total of 114 adult LN patients were included for final analysis. The mean (± SD) age of the LN patients at onset was 29.10 ± 9.67 years and 99 (86.8%) of all the patients were females. More than three-fourths (78.9%) of the LN patients had a good prognosis. However, 24 (21.1%) of the patients who didn’t achieve complete or partial remission had a poor prognosis. A kidney biopsy was done for 71 patients at initial presentation with class IV and III as the commonest class. The commonly prescribed immunosuppressive medications were cyclophosphamide as induction therapy in 67 (58.7%) and mycophenolate mofetil (MMF) as maintenance therapy in 76 (66.7%). Gastrointestinal intolerances like abdominal pain, nausea, or diarrhea from MMF were the most common 27(31.2%) treatment-related adverse events reported. Acute kidney injury (AKI) at onset (AOR = 4.83, P = 0.026), high serum creatinine (SCr) at six months (AOR = 0.12, P = 0.003), no response at six months to attain complete remission (AOR = 0.05, P = 0.041) and presence of flare (AOR = 0.04, P = 0.004) were predictors poor treatment outcomes.

CONCLUSION: Despite good response with the present immunosuppressive regimens, relapse, treatment-related complications and adverse events are major problems that require close monitoring. The results and identified gaps of this study are used as an input to improve the management practice of LN in the study setting. Overall, this study is comparable with other findings and strengthen the present available literatures.

PMID:35715762 | DOI:10.1186/s12882-022-02846-z