Quality Management in Polish Biobanking Network—Current Status Before the Implementation of Unified and Harmonized Integrated Quality Management System

In 2017, Polish Biobanking Network was established in Poland, within BBMRI.pl project titled “Organization of Polish Biobanking Network within the Biobanking and Biomolecular Resources Research Infrastructure BBMRI-ERIC” as a strategic scientific infrastructure concept. One of the key elements of the project was the verification of the current status of QMS in the Polish biobanking institutions and the implementation of common solutions. The main goal was to indicate the current QMS level and determine the starting points for QMS development for each biobank of the Polish Biobanking Network (PBN). Within 3 years, 35 audit visits were performed. The current status and the level of QMS implementation in each biobank were assessed. Five hundred and seventy recommendations were prepared. The data was analyzed using Fischer Exact test to determine whether or not a significant association was observed. Three areas of analysis were covered: (1) BBMRI.pl status, (2) QMS implementation level and (3) private/public party, respectively. The results were discussed within 15 areas. Concluding remarks showed that some differences were observed in the case of subgroups analysis. There is convergence in QMS within the biobanks where Tissue Banks are located. Moreover, some discrepancies between the QMS implementation level in BBMRI.pl Consortium biobanks and PBN biobanks are observed. Nevertheless, the consortium members are obliged to prepare other biobanks willing to enter the PBN as Members/Observers or which already are in the PBN, so that they can meet the requirements of the quality management system that will enable efficient management of biobanking processes in these units. That is why some actions within BBMRI.pl projects are organized to help the whole biobanking community in Poland implement the harmonized solution.

Antenatal umbilical cord coiling index as a predictor of pregnancy outcome

: Fetal compromise as a major contributor to neonatal morbidity is of great concern for obstetricians. Antenatal risk assessment profiles are often insufficient in picking up these cases and hence need to be improved. Antenatal Umbilical cord Coiling Index (AUCI) is one such potential predictor which helps in identifying pregnant women who need close antepartum and intrapartum monitoring. It is determined by ultrasonogram antenatally and noted to be fixed throughout the pregnancy. This study aims at determining the association between AUCI and pregnancy outcome.: This was a hospital based prospective analytical study conducted in a tertiary care centre in Pondicherry from January 2019 to May 2020. 207 pregnant women were included in the study and Colour doppler was performed and AUCI was noted. Participants were followed until delivery and pregnancy outcomes were noted.: Chi square and Fischer exact test: In the present study, among 207 subjects, 166 had normal AUCI i.e., 0.41 to 0.61. Hypocoiling was noted in 20 (< 0.41) and hypercoiling in 21(>0.61) subjects. Hypocoiling was associated with hypertension and oligohydramnios in10% cases each. Nonreasssuring fetal (NRFHR) heart rate, meconium stained liquor and low APGAR values were present in 15, 20 and 10% cases respectively. Hypercoiling was associated with diabetes (10%), hypertension (5%), oligohydramnios (10%), polyhydramnios (5%), NRFHR (10%) and meconium stained liquor (5%). However, there was no statistical significance among the above mentioned parameters.

Evaluation of bioactive glass and hydroxyapatite crystals as pulpotomy agents in primary molars: A clinical study

Aim: To clinically and radiographically evaluate the potential of bioactive glass and hydroxyapatite crystals as pulpotomy agents in primary molars. Methods: A total of fifty teeth were selected from 25 children (14 boys and 11 girls) aged 4 to 9 years, who had no medical condition that would contraindicate pulp therapy. Each child had at least two primary molars (first and/or second primary molar) requiring pulpotomy. A conventional pulpotomy procedure was performed on the selected teeth using bioactive glass and hydroxyapatite crystals. All molars were evaluated clinically and radiographically at regular intervals over 12 months. The results were subjected to statistical analysis using Fischer exact test. Results: One hundred percent clinical success and 84% radiographic success was observed in both the groups at the end of the study period. Conclusions: The study concluded that both bioactive glass and hydroxyapatite crystals can be used as pulpotomy agents in primary molars.

Food supplement consumption does not related to self-reported symptoms of covid-19 among students in Binawan University

The world is facing a pandemic of COVID-19. Multivitamin and other supplement is already known can improve immunity and prevent infected by the virus. The purpose of this study was to determine the relationship of multivitamin/supplement intake with the appearance of COVID-19 symptoms. The method of this study was analytic surveys with cross-sectional designs. The questionnaire was distributed twice, the first distribution phase involved 423 respondents to determine the consumption habits of supplements and the appearance of COVID-19 symptoms. Then, from the respondents who consumed supplements, the second questionnaire was sent again, to find out the type of supplements consumed, and only 127 respondents returned completely. As a respondent, we involved students of Binawan University, Jakarta, Indonesia. We used Pearson Chi-Square and Fischer exact test for statistical analysis. The results of this study noted that 67.7% of respondents consumed supplements/multivitamin, 94.8% of respondents did not show symptoms of COVID-19. The type of supplement consumed by most respondents was vitamin C (51.2%), while multivitamins / other vitamins were 20.1%. In conclusion, based on statistical analysis, there was no significant relationship between supplement consumption with the appearance of COVID-19 and conditions in carrying out daily activities on respondents who show COVID-19 symptoms

Inner Prepuce Preserving ‘Bird-Winged Coronal-Collar Skin ReArrangement’ Modification of Tip Urethroplasty

Objective: To describe the ‘Bird-Winged Coronal-Collar Skin re-arrangement modification’ of the Tubularized Incised Plate (TIP) urethroplasty to preserve the inner preputial skin on the ventral surface of the penile shaft. Material and Method: Study Group: Prospective review of the results of a single surgeon with Bird-Winged Coronal-Collar skin re-arrangement modification of TIP urethroplasty (n=111; mean age 4.9 years) of distal (n=76) and mid-penile (n-35) hypospadias (mean follow-up 37 months). Control Group: Retrospective review of a single surgeon’s results of distal and mid-penile hypospadias repair with standard TIP urethroplasty (2007-11). Outcome parameters (to compare non-inferiority of the modified technique): Urethro-cutaneous fistula (UCF) at voiding trial and follow-up at 3 months, wound infection, complete dehiscence, local edema, meatal stenosis and quality of urinary stream. Statistical analysis was done with the Fischer Exact Test. Results: With this technique, the authors could provide an inner preputial cover on the ventral/ ventro-lateral aspects of distal penile shaft in all but one patient (complete dehiscence). The results of ‘bird-winged coronal-collar skin re-arrangement’ modification were not-inferior/ comparable to those of standard TIP urethroplasty. Conclusions: The modification is technically feasible and reproducible and the overall results of urethroplasty were not inferior to the standard TIPS procedure.

Incidence of Dural Injury during Craniotomy - a Single Center Study

Background: During a craniotomy, there is a high chance of unintentional dural tear and may occur in both layers or only in the outer layer.ith the objective to see the incidence of dural tear during craniotomy using high-speed craniotome, this study was performed. Materials and methods: This is a prospective analytical study collected over the duration of 4 months. Cases of craniotomy done using the craniotome were collected. Age was presented as mean and standard deviation (S.D). Gender, diagnosis, and dural tear were presented in frequencies and percentages. Analysis of gender, diagnosis categories, and age categories with a dural tear was done using the Fischer exact test. Similarly, Pearson's correlation was done between the number of burr holes made and dural tear in SPSS20. Results: There were a total of 25 craniotomies performed during the study period using craniotome. The mean age of presentation was 43.32 (17.65) years. The incidence of the dural tear was noted in 20% of the cases which includes a single layer or both the layers of the dura. There was a significant association between different age categories and dural tear; where elderly patients seem to have more percentage of the dural tear. Conclusion: There was a 20% incidence of dural tear during craniotomy with a significantly higher incidence in the elderly population.

Caregiver’s Recall of Stroke Discharge Education Exceeds Patients and Is Associated With Greater Satisfaction

Stroke survivors and their caregivers report not receiving enough information at discharge. To identify strengths and weaknesses of stroke discharge education, we delivered questionnaires that assessed patient and caregiver recall, perceived utility, and satisfaction at discharge as well as 1- and 3-month follow-up. Categorical data of responses were compared between time periods using Fischer exact test. Recall significantly differed between discharge (86%) and 1-month follow-up (54%, P < .05), but not discharge and 3-month follow-up (69%). Patient perceived utility at both 1 month (69%) and 3 months (64%) was lower than at discharge (92%, P < .05). Patient satisfaction was lower at 1 month (69%) and 3 months (54%) than discharge (92%, P < .05). Caregiver recall declined from discharge (81%) to 1 month (65%) but improved from 1 to 3 months (82%, P < .05). Caregiver satisfaction and perceived utility remained positive through the study. The results suggest stroke patients and their caregivers suffer from education recall failure over time that is associated with worse satisfaction and perceived utility by patients. Reinforcement at 1 month may improve caregiver recall. We conclude that education for caregivers may be more reliably reinforced, suggesting a role in continued patient education.

Association between gene fusions and anti-EGFR resistance signature in colorectal cancer.

3564 Background: Acquired resistance to anti-EGFR therapy in metastatic colorectal cancer (mCRC) has been characterized by a circulating tumor DNA (ctDNA) signature including any sub-clonal RAS mutation, co-existing RAS mutations, or co-existing EGFR mutations. Here, we investigated if fusions in ctDNA are associated with this anti-EGFR signature for CRC patients (pts). Methods: 4289 advanced stage CRC pts underwent molecular profiling using a plasma-based NGS assay that included FGFR2, FGFR3, RET, ALK, NTRK1, and ROS1 fusions. Available clinical histories were reviewed. Correlations between fusions and clinicopathological features were measured with a Fischer exact test. Relative frequencies of genomic alterations were compared between fusion-present vs -absent cases with an unpaired t-test. Clonality for a given alteration was called for a relative variant allele frequency (rVAF) > 50 %, while subclonal was defined as < 50% rVAF. Results: 44 unique fusions were detected in 40 (1.1%) of the 3808 pts with alterations present: RET (N = 16), FGFR3 (N = 12), ALK (N = 10), NTRK1 (N = 3), ROS1 (N = 2), and FGFR2 (N = 1). Relative to non-fusion variants detected, fusions were more likely to be subclonal (OR 8.2, p < 0.0001). Mutations associated with a previously reported anti-EGFR resistance were found in FGFR3 (7/12 pts), RET (7/15 pts) and ALK (5/10 pts). In fusion-present cases, co-existing RAS mutations were more likely to be subclonal than non-fusion cases (OR 14, p < 0.0001). EGFR mutations were more common in fusion present cases (OR 3.7, p = 0.0001) and predominantly subclonal (97%). EGFR mutations aggregated to ectodomain sites (85%) previously linked to acquired anti-EGFR resistance. For 27 pts with available clinical histories, 21 (78%) received anti-EGFR treatment prior to ctDNA testing. Conclusions: Actionable fusions using a ctDNA NGS assay were predominantly subclonal and co-existed with subclonal RAS and EGFR mutations. These clinicopathologic features are consistent with a previously validated signature linked to resistance to anti-EGFR therapies in CRC. We hypothesize that fusions may arise as a previously undescribed mechanism of acquired resistance to anti-EGFR therapies in CRC pts.

SYSTEM FOR DETECTION OF NATIONAL HEALTHCARE INSURANCE FRAUD BASED ON COMPUTER APPLICATION

Background: The national healthcare insurance (JKN) has been in deficit since 2014-2016; one of the causes is fraud inpatient hospital service. Objective: This study aimed to analyze the validity, reliability and effectiveness of detection system of national healthcare insurance fraud based on computer application in hospital.Methods: Cross-sectional method was used. Fraud data were collected at one episode in the inpatient JKN participant service.Results: Validity was assessed by Fischer exact test. The interpretation was done by hospital internal verification officer and BPJS Kesehatan verification officer. There were only 2 out of 1.106 services claims were different, resulted in p-value 0.01. Reliability was assessed using Human Organization Technology Benefit questionnaire filled by admission administrator officer, BPJS Kesehatan officer and hospital internal verification officer; and then analyzed using Stata® software resulting in Cronbach’s alpha value of 0.8. Effectiveness was assessed by reducing potential fraud, conducted by RSUP dr. Soeradji Tirtonegoro from May until July 2017, which on May 2018 there were 8 findings, June 1 finding, and on July 2018 had no finding.Conclusion: System for detection of national healthcare insurance fraud based on computer application is valid, reliable and effective to be implemented in inpatient service in hospital.

Knowledge and Use of Dietary Supplement Products by Deaf Athletes

The purpose of this study was to determine the knowledge and use of dietary supplement products (DSP) among the deaf athletes of the Turkish Deaf Sports Federation. A total 74 voluntary athletes from various sports, 11 female and 63 male athletes (Mage=23.62±5.38 years) participated in this study. The data was collected through the survey method and was analyzed by Fischer Exact test, frequencies and percentage distribution. As a result, it has been determined that 39.2% of deaf athletes have knowledge about DSP and athlete diets; their rate of DSP use increases as their educational level increases; the rate of DSP use in national athletes is higher and that taekwondo athletes do not use DSP while a rate of at least 30.8% DSP use is evident in other branches. In addition, the findings show that the deaf athletes do not have sufficient knowledge about their DSP use and they have problems in accessing reliable information about this issue.