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Nevin Manimala Statistics

Statistical analysis plan for Better Evidence for Selecting Transplant Fluids (BEST-Fluids): a randomised controlled trial of the effect of intravenous fluid therapy with balanced crystalloid versus saline on the incidence of delayed graft function in deceased donor kidney transplantation

Trials. 2022 Jan 18;23(1):52. doi: 10.1186/s13063-021-05989-w.

ABSTRACT

BACKGROUND: Delayed graft function, or the requirement for dialysis due to poor kidney function, is a frequent complication of deceased donor kidney transplantation that is associated with inferior outcomes. Intravenous fluids with a high chloride content, such as isotonic sodium chloride (0.9% saline), are widely used in transplantation but may increase the risk of poor kidney function. The primary objective of the BEST-Fluids trial is to compare the effect of a balanced low-chloride crystalloid, Plasma-Lyte 148 (Plasmalyte), versus 0.9% saline on the incidence of DGF in deceased donor kidney transplant recipients. This article describes the statistical analysis plan for the trial.

METHODS AND DESIGN: BEST-Fluids is an investigator-initiated, pragmatic, registry-based, multi-centre, double-blind, randomised controlled trial. Eight hundred patients (adults and children) in Australia and New Zealand with end-stage kidney disease admitted for a deceased donor kidney transplant were randomised to intravenous fluid therapy with Plasmalyte or 0.9% saline in a 1:1 ratio using minimization. The primary outcome is delayed graft function (dialysis within seven days post-transplant), which will be modelled using a log-binomial generalised linear mixed model with fixed effects for treatment group, minimization variables, and ischaemic time and a random intercept for study centre. Secondary outcomes including early kidney transplant function (a ranked composite of dialysis duration and the rate of graft function recovery), treatment for hyperkalaemia, and graft survival and will be analysed using a similar modelling approach appropriate for the type of outcome.

DISCUSSION: BEST-Fluids will determine whether Plasmalyte reduces the incidence of DGF and has a beneficial effect on early kidney transplant outcomes relative to 0.9% saline and will inform clinical guidelines on intravenous fluids for deceased donor kidney transplantation. The statistical analysis plan describes the analyses to be undertaken and specified before completion of follow-up and locking the trial databases.

TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12617000358347 . Prospectively registered on 8 March 2017 ClinicalTrials.gov identifier NCT03829488 . Registered on 4 February 2019.

PMID:35042554 | DOI:10.1186/s13063-021-05989-w

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Nevin Manimala Statistics

Morbimortality assessment in abdominal surgery: are we predicting or overreacting?

BMC Surg. 2022 Jan 18;22(1):19. doi: 10.1186/s12893-021-01455-1.

ABSTRACT

BACKGROUND: High-risk surgical procedures represent a fundamental part of general surgery practice due to its significant rates of morbidity and mortality. Different predictive tools have been created in order to quantify perioperative morbidity and mortality risk. POSSUM (Physiological and Operative Severity Score for the enumeration of Mortality and morbidity) is one of the most widely validated predictive scores considering physiological and operative variables to precisely define morbimortality risk. Nevertheless, seeking greater accuracy in predictions P-POSSUM was proposed. We aimed to compare POSSUM and P-POSSUM for patients undergoing abdominal surgery.

METHODS: A retrospective observational study with a prospective database was conducted. Patients over 18 years old who complied with inclusion criteria between 2015 and 2016 were included. Variables included in the POSSUM and P-POSSUM Scores were analyzed. Descriptive statistics of all study parameters were provided. The analysis included socio-demographic data, laboratory values ​​, and imaging. Bivariate analysis was performed.

RESULTS: 350 Patients were included in the analysis, 55.1% were female. The mean age was 55.9 ± 20.4 years old. POSSUM revealed a moderated index score in 61.7% of the patients, mean score of 12.85 points ± 5.61. 89.1% of patients had no neoplastic diagnosis associated. Overall morbidity and mortality rate was 14.2% and 7.1%. P-POSSUM could predict more precisely mortality (p < 0.00).

CONCLUSIONS: The POSSUM score is likely to overestimate the risk of morbidity and mortality in patients with high/moderate risk, while the P-POSSUM score seems to be a more accurate predictor of mortality risk. Further studies are needed to confirm our results.

PMID:35042495 | DOI:10.1186/s12893-021-01455-1

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Effects of swab pool size and transport medium on the detection and isolation of avian influenza viruses in ostriches

BMC Vet Res. 2022 Jan 18;18(1):48. doi: 10.1186/s12917-022-03150-6.

ABSTRACT

BACKGROUND: Rigorous testing is a prerequisite to prove freedom of notifiable influenza A virus infections in commercially farmed ostriches, as is the isolation and identification of circulating strains. Pooling 5 ostrich tracheal swabs in a 50 % v/v phosphate-buffered saline (PBS): glycerol transport medium (without antibiotics) is the current standard practice to increase reverse transcription real time PCR (RT-rtPCR) testing throughput and simultaneously reduce the test costs. In this study we investigated whether doubling ostrich tracheal swabs to 10 per pool would affect the sensitivity of detection of H5N8 high pathogenicity avian influenza virus (HPAIV) and H7N1 low pathogenicity avian influenza virus (LPAIV) by quantitative RT-rtPCR, and we also compared the effect of a protein-rich, brain heart infusion broth (BHI) virus transport media containing broad spectrum antimicrobials (VTM) on the efficacy of isolating the H5N8 and H7N1 viruses from ostrich tracheas, since the historical isolation success rate from these birds has been poor.

RESULTS: Increasing the ostrich swabs from 5 to 10 per pool in 3 mls of transport medium had no detrimental effect on the sensitivity of the RT-rtPCR assay in detecting H5N8 HPAIV or H7N1 LPAIV; and doubling of the swab pool size even seemed to improve the sensitivity of virus detection at levels that were statistically significant (p less than or equal to 0.05) in medium and low doses of spiked H5N8 HPAIV and at high levels of spiked H7N1 LPAIV. On virus isolation, more samples were positive when swabs were stored in a protein-rich viral transport medium supplemented with antimicrobials in PBS: glycerol (10/18 vs. 7/18 for H5N8 HPAI); although the differences were not statistically significant, overall higher virus titres were detected (106.7 – 103.0 vs. 106.6 – 103.1 EID50 for H5N8 HPAIV and 105.5 – 101.4 vs. 105.1 – 101.3 EID50 for H7N1 LPAIV); and fewer passages were required with less filtration for both H5N8 HPAI and H7N1 LPAI strains.

CONCLUSION: Ostrich tracheal swab pool size could be increased from 5 to 10 in 3mls of VTM with no loss in sensitivity of the RT-rtPCR assay in detecting HPAI or LPAI viruses, and HPAI virus could be isolated from a greater proportion of swabs stored in VTM compared to PBS: glycerol without antibiotics.

PMID:35042528 | DOI:10.1186/s12917-022-03150-6

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Examining COVID-19 vaccine uptake and attitudes among 2SLGBTQ+ youth experiencing homelessness

BMC Public Health. 2022 Jan 18;22(1):122. doi: 10.1186/s12889-022-12537-x.

ABSTRACT

OBJECTIVES: The COVID-19 pandemic has disproportionately impacted 2SLGBTQ+ youth experiencing homelessness. Little is known about vaccine attitudes and uptake among this population. To address this, the objectives of this study were to explore this group’s COVID-19 vaccine attitudes, and facilitators and barriers impacting vaccine uptake.

METHODS: 2SLGBTQ+ youth experiencing homelessness in the Greater Toronto Area were recruited to participate in online surveys assessing demographic characteristics, mental health, health service use, and COVID-19 vaccine attitudes. Descriptive statistics and statistical tests were used to analyze survey data to explore variables associated with vaccine confidence. Additionally, a select group of youth and frontline workers from youth serving organizations were invited to participate in online one-on-one interviews. An iterative thematic content approach was used to analyze interview data. Quantitative and qualitative data were merged for interpretation by use of a convergent parallel analytical design.

RESULTS: Ninety-two youth completed surveys and 32 youth and 15 key informants participated in one-on-one interviews. Quantitative and qualitative data showed that the majority of 2SLGBTQ+ youth experiencing homelessness were confident in the COVID-19 vaccine; however, numerous youth were non-vaccine confident due to mistrust in the healthcare system, lack of targeted vaccine-related public health information, concerns about safety and side effects, and accessibility issues. Solutions to increase vaccine confidence were provided, including fostering trust, targeted public health messaging, and addressing accessibility needs.

CONCLUSION: Our study highlights the need for the vaccine strategy and rollouts to prioritize 2SLGBTQ+ youth experiencing homelessness and to address the pervasive health disparities that have been exacerbated by the pandemic.

PMID:35042491 | DOI:10.1186/s12889-022-12537-x

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Percussion test: description and diagnostic accuracy of a new manual test for bone marrow edema of the knee

BMC Musculoskelet Disord. 2022 Jan 18;23(1):68. doi: 10.1186/s12891-022-05028-y.

ABSTRACT

BACKGROUND: Prompt diagnosis of bone marrow lesion (BML) is difficult but critical for correct treatment. Magnetic resonance imaging is the gold standard, although expensive and time consuming. Simple and reliable clinical test for BML detection is lacking. Aim of the study is to describe a new manual clinical test called Percussion Test (PT) and to statistically determine its diagnostic accuracy in BML, compared to MRI imaging.

METHODS: After evaluation of the inclusion and exclusion criteria, 218 consecutive patients with unilateral knee pain and age comprised between 18 and 80 years old were enrolled in our observational prospective study. Informed consent was obtained for each patient. After medical history collection, PT was performed by a single operator as described. MRI was performed in the affected knee to detect the presence of BML. Coherence in PT and MRI assessment was evaluated in each quadrant of the knee via contingency tables, as sensitivity, specificity, NPV, PPV and diagnostic accuracy were calculated.

RESULTS: No correlation with a positive PT was demonstrated for the covariables gender (p = 0.156), age (p = 0.272) and BMI (p = 0.639). PT showed a sensitivity ranging from 60.6 (40.6-80.6) to 79.5 (63.0-96.0) and a specificity ranging from 85.7 (80.0-91.5) to 96.0 (93.1-98.9) depending on knee quadrant. Diagnostic accuracy ranged from 81.6 (75.9-86.6) to 89.4 (84.6-93.2), and p-value was < 0.00001 in a chi-squared analysis for all quadrants.

CONCLUSIONS: PT showed sensitivity and specificity values that are comparable with other clinical tests routinely adopted in clinical practice. In the absence of other reliable clinical test, PT has the potential to become a useful bedside tool in the diagnosis and management of BMLs.

PMID:35042479 | DOI:10.1186/s12891-022-05028-y

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Nevin Manimala Statistics

Health beliefs and behaviors of livestock industry workers regarding Crimean-Congo hemorrhagic fever in Northwest of Iran

BMC Health Serv Res. 2022 Jan 18;22(1):86. doi: 10.1186/s12913-022-07487-4.

ABSTRACT

BACKGROUND: Crimean-Congo hemorrhagic fever (CCHF) is an acute, feverous disease that is caused by tick bites or humans’ direct contact with the blood and tissues of infected livestock and humans. The transmission of the disease is also possible via human-to-human contacts and nosocomial transmission is well described. The majority of patients suffering from this disease are slaughterhouse workers (including butchers), farmers, veterinarians and hospital staff. Thus, this study aimed to investigate the health behaviors of butchers regarding CCHF and study factors affecting such behaviors based on the health belief model.

METHODS: This is a descriptive cross-sectional study conducted on 500 butchers in Ardabil Province in 2020 by a multistage sampling method. The participants of the study completed the researcher-made questionnaire of health belief model and health behaviors model relevant to CCHF. The collected data were then analyzed by descriptive statistical tests and linear regression analysis.

RESULTS: The mean (SD) age of the participants was 44.4 (10.5) years, and 96% were males. Only 11.1% of the participants displayed acceptable disease-preventive behaviors. The validity and reliability of the developed questionnaire were confirmed. The results of the exploratory factor analysis showed that the constructs of the model explained 84% of the total variance. The results of the study revealed that among the variables of the health belief model, perceived susceptibility (p-value = 0.006, β = 0.152) and perceived barriers (p-value = 0.023, β = 0.14) were the strongest factors predicting disease-preventive behaviors regarding CCHF.

CONCLUSION: The results of the study showed that the health belief model can predict preventive behaviors for CCHF. Therefore, designing and executing interventions based on the results of this study may encourage such preventive behaviors in butchers.

PMID:35042487 | DOI:10.1186/s12913-022-07487-4

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Nevin Manimala Statistics

Knowledge, attitudes, and perceptions of COVID-19 vaccine and refusal to receive COVID-19 vaccine among healthcare workers in northeastern Ethiopia

BMC Public Health. 2022 Jan 18;22(1):128. doi: 10.1186/s12889-021-12362-8.

ABSTRACT

BACKGROUND: Major efforts are being made to control the spread and impacts of the coronavirus pandemic using vaccines. Ethiopia began on March 13, 2021, to vaccinate healthcare workers (HCWs) for COVID-19 with the AstraZeneca vaccine. However, willingness to be vaccinated depends to a large extent on factors beyond the availability of vaccines. This study aimed to determine the rate of intention to refuse COVID-19 vaccination and associated factors among HCWs in northeastern Ethiopia. northeastern, Ethiopia.

METHOD: An institution-based cross-sectional study was employed among 404 HCWs in Dessie City, northeastern Ethiopia in May, 2021. Data were collected, checked, coded, entered into EpiData Version 4.6 and exported to Statistical Package of Social Sciences (SPSS) Version 25.0 for cleaning and analysis. The dependent variable was refuse to receive COVID-19 vaccination and the independent variables included socio-demographic factors, knowledge, attitudes and perceptions. A Binary logistic regression model was used to determine the association between vaccine refusal and the independent variables. From bivariate analysis, variables with p-values < 0.25 were retained for multivariable analysis. From multivariable analysis, variables with adjusted odds ratio (AOR), p-values <0.05 at 95% confidence interval (CI) were declared as factors significantly associated with refusal to be vaccinated among HCWs in Dessie City, northeastern Ethiopia.

RESULTS: The proportion of HCWs with overall good knowledge, good perception, and positive attitudes about COVID-19 vaccination were 62.5%, 60.5%, and 52.3%, respectively; 64.0% of the HCWs wanted to be vaccinated while 36.0% said that they would refuse to do so. Multivariable analysis identified negative attitudes (AOR: 3.057; 95%CI [1.860 – 5.026]) and poor perceptions (AOR: 4.73; 95%CI [2.911 – 7.684]) about COVID-19 vaccines were significantly associated with refusal to be vaccinated for COVID-19. Nearly half (46.9%) of the HCWs stated that vaccines could worsen any pre-existing medical conditions and 39.5% of them thought that vaccines could cause COVID-19 infections.

CONCLUSION: The willingness of HCWs to get vaccinated against COVID-19 was relatively high among HCWs. Negative attitudes and poor perceptions towards the anticipated COVID-19 vaccination were significant factors to refuse to be vaccinated. Our findings may provide information for the management authorities and stakeholders to promote and improve attitudes, knowledge and perceptions towards COVID-19 vaccination uptake among HCWs.

PMID:35042476 | DOI:10.1186/s12889-021-12362-8

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Nevin Manimala Statistics

Radiosynthesis of a novel antisense imaging probe targeting LncRNA HOTAIR in malignant glioma

BMC Cancer. 2022 Jan 18;22(1):79. doi: 10.1186/s12885-022-09170-7.

ABSTRACT

BACKGROUND: Long non-coding RNA (LncRNA) HOTAIR was amplified and overexpressed in many human carcinomas, which could serve as a useful target for cancer early detection and treatment. The 99mTc radiolabeled antisense oligonucleotides (ASON) could visualize the expression of HOTAIR and provide a diagnostic value for malignant tumors. The aim of this study was to evaluate whether liposome-coated antisense oligonucleotide probe 99mTc-HYNIC-ASON targeting HOTAIR can be used in in vivo imaging of HOTAIR in malignant glioma xenografts.

METHODS: The ASON targeting LncRNA HOTAIR as well as mismatched ASON (ASONM) were designed and modified. The radiolabeling of 99mTc with two probes were via the conjugation of bifunctional chelator HYNIC. Then probes were purified by Sephadex G25 and tested for their radiolabeling efficiency and purity, as well as stability by ITLC (Instant thin-layer chromatography) and gel electrophoresis. Then the radiolabeled probes were transfected with lipofectamine 2000 for cellular uptake test and the next experimental use. Furthermore, biodistribution study and SPECT imaging were performed at different times after liposome-coated 99mTc-HYNIC-ASON/ASONM were intravenously injected in glioma tumor-bearing mice models. All data were analyzed by statistical software.

RESULTS: The labeling efficiencies of 99mTc-HYNIC-ASON and 99mTc-HYNIC-ASONM measured by ITLC were (91 ± 1.5) % and (90 ± 0.6) %, respectively, and both radiochemical purities were more than 89%. Two probes showed good stability within 12 h. Gel electrophoresis confirmed that the oligomers were successfully radiolabeled no significant degradation were found. Biodistribution study demonstrated that liposome-coated antisense probes were excreted mainly through the kidney and bladder and has higher uptake in the tumor. Meanwhile, the tumor was clearly shown after injection of liposome coated 99mTc-HYNIC-ASON, and its T/M ratio was higher than that in the non-transfection group and mismatched group. No tumor was seen in mismatched and blocking group.

CONCLUSION: The liposome encapsulated 99mTc-HYNIC-ASON probe can be used in the in vivo, real-time imaging of LncRNA HOTAIR expression in malignant glioma.

PMID:35042456 | DOI:10.1186/s12885-022-09170-7

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Nevin Manimala Statistics

Correlation between the pre-and post-operative sagittal parameters and the quality of life in patients with degenerative and isthmic spondylolisthesis

Zhonghua Yi Xue Za Zhi. 2022 Jan 18;102(3):228-234. doi: 10.3760/cma.j.cn112137-20210720-01614.

ABSTRACT

Objective: To assess the relationship between health-related quality of life (HRQOL) and spinal sagittal parameters in patients with degenerative and isthmic spondylolisthesis before and after surgery, and to provide a biomechanical basis for improving the clinical prognosis of such patients. Methods: A retrospective analysis of 63 patients with lumbar spondylolisthesis who received lumbar fusion surgery in the Department of Spine Surgery, Tianjin Union Medical Center from December 2017 to June 2020 was carried out. There were 16 males and 47 females with a mean age of (59±8) years. Subgroup analyses were conducted based on disease type (degenerative lumbar spondylolisthesis (DS) and the isthmic spondylolisthesis (IS)) and HRQOL scores. Patients were evaluated post-operatively to observe the improvement of symptoms and quality of life. The relationship between operative related factors, HRQOL scores before and after surgery, and spino-pelvic sagittal parameters (including sagittal axis of the spine, lumbar lordosis angle, pelvic incidence angle, pelvic tilt angle (PT), sacral tilt angle, matching degree of pelvic incidence angle (PI) and lumbar lordosis angle (LL), lumbar 1 vertebra plumb line, upper lumbar curve, lower lumbar curve) in the two groups were analyzed. The correlation between the improvement of HRQOL scores and spino-pelvic sagittal parameters in the DS group and the IS group was analyzed and compared. Results: There were significant differences between postoperative HRQOL scores compared with those before the operation in both the DS and IS groups at three times of follow-up after the operation (all P<0.05). There was no difference in the last HRQOL score, the number of surgical segments, operation time and intraoperative blood loss between the two groups (all P>0.05). The parameters of PT and PI-LL in DS patients with VAS back pain score>3 and ≤3 were statistically different (13.7°±6.4° vs 26.6°±7.4°, 5.1°±8.2° vs 18.2°±13.1°, respectively, both P<0.05), similar results were obtained in IS patients (14.1°±6.9° vs 16.4°±8.7°, 2.9°±9.7° vs 6.8°±9.8°, respectively, both P<0.05). In addition, the parameters of PT and PI-LL between patients with ODI>20 and ≤20 were all statistically different in the two groups at the last follow-up after surgery (all P<0.05). The improvement of VAS back pain score in DS and IS groups was significantly related to the improvement of PT value, respectively (r=0.76, 0.78, both P<0.05). The PT, LL and PI-LL were significantly correlated with the ODI in the DS group (r=0.60, 0.62, 0.50, all P<0.05). There was also a correlation between the improvement of ODI and PT, LL and PI-LL in the IS group, respectively (r=0.22, 0.41, 0.76, all P<0.05). Conclusions: Certain correlation exists between the HRQOL and spinal sagittal parameters in patients with degenerative and isthmic spondylolisthesis before and after surgery. For the treatment of lumbar spondylolisthesis and improvement of quality of life, the primary goal is to reconstruct the matching degree of the lumbar lordosis angle and PI, and to reduce the PT value to the normal range by tilting the pelvis forward.

PMID:35042293 | DOI:10.3760/cma.j.cn112137-20210720-01614

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National external quality assessment for molecular detection of severe acute respiratory syndrome coronavirus 2 Delta variant

Zhonghua Yi Xue Za Zhi. 2022 Jan 18;102(3):216-221. doi: 10.3760/cma.j.cn112137-20211018-02299.

ABSTRACT

Objective: To clarify the impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Delta variant on the performance of existing molecular diagnostic assays, and investigate the detection ability of clinical laboratories across China. Methods: The first nationwide external quality assessment (EQA) for molecular detection of Delta variant was carried out based on the non-infectious phage virus-like particles samples, which were prepared by genetic engineering methods and distributed to 8 488 laboratories nationwide. The EQA panel was composed of three Delta variant samples (7.5×102, 1.5×103 and 6.0×103 copies/ml), one non-variant weak positive sample and one negative sample. The percentage of agreement (PA) of Delta variant samples with different concentration, the PA of Delta variant and non-variant samples with 7.5×102 copies/ml, the PA of assays used by more than 100 laboratories for Delta variant samples with different concentration and the PA of Delta variant and non-variant samples with 7.5×102 copies/ml were calculated and analyzed. Results: The data from 8 127 laboratories were available for evaluation. The testing capability of 98.77% (8 027/8 127) of the participating laboratories was found to be competent in reporting correct results for all samples. The overall percentage of agreement (OPA), negative percentage of agreement (NPA) and positive percentage of agreement (PPA) of the samples were 99.64% (40 490/40 635), 99.73% (8 105/8 127), 99.62% (32 385/32 508), respectively. With the decrease of the concentration of the samples, the PPA of Delta variant samples decreased. The PPAs were 99.41% and 99.51% for Delta variant and non-variant samples with 7.5×102 copies/ml, respectively, with no statistical difference (P=0.392). The OPA, NPA and PPA of the assays used by more than 100 laboratories were all greater than 98%, and no statistical difference of the PPAs was identified between Delta variant and non-variant samples with 7.5×102 copies/ml (P>0.05). Conclusions: Delta variant fails to impair the performance of current molecular diagnostic assays in China. The clinical laboratories have the same detection capabilities for Delta variant and non-variant samples. However, in certain laboratories, further improvement is required to ensure the accurate detection of weak positive samples.

PMID:35042291 | DOI:10.3760/cma.j.cn112137-20211018-02299