Category: Statistics

Mol Biol Rep. 2021 Nov 18. doi: 10.1007/s11033-021-06956-z. Online ahead of print.

ABSTRACT

BACKGROUND: Folate has a pivotal role in maintaining different cellular processes including DNA integrity and neurotransmitter levels. Further, folate deficiency was reported in subjects with neuropsychiatric disorders including autism spectrum disorder (ASD).

METHODS AND RESULTS: We recruited ASD probands following the Diagnostic and Statistical Manual of Mental Disorder-IV/-5. Severity was assessed by the Childhood Autism Rating Scale2-Standard Test (CARS2-ST). Functional SNPs in reduced folate carrier1 (rs1051266), methylenetetrahydrofolate dehydrogenase (rs2236225), methylenetetrahydrofolate methyltransferase (rs1805087), methylenetetrahydrofolate reductase (rs1801133 and rs1801131), cystathionine-beta- synthase (rs5742905), and serine hydroxymethyltransferase (rs1979277) genes were analyzed in the ASD probands (N = 203), their parents and controls (N = 250) by PCR/TaqMan based methods. Plasma homocysteine and vitamin B12 levels were examined by Enzyme-Linked ImmunoSorbent Assay. Statistical analysis revealed higher frequencies of rs1051266 and rs1805087 “A” alleles (P = 8.233e-005 and P = 0.010 respectively) and rs1051266 “AA” genotype (P = 0.02) in the ASD probands. Gender based stratified analysis revealed higher frequency of rs1051266 “AA” in the male probands (P = 0.001) while frequencies of rs1805087 “A” (P = 0.001) and “AA” (P < 0.05), and rs2236225 “CC” (P = 0.03) were higher in the females. The case-control analysis also exhibited a significant difference in the occurrence of biallelic and triallelic haplotypes. rs1051266 “A”, rs1979277 “T” and rs5742905 “C” alleles showed biased parental transmission (P = 0.02). CARS2-ST scores were higher in the presence of rs5742905 “T” while scores were lower in the presence of rs1979277 “T” and rs1051266 “A”. ASD probands showed vitamin B12 deficiency.

CONCLUSION: Based on these observations, we infer that components needed for proper folate metabolism may influence ASD severity in this population.

PMID:34792727 | DOI:10.1007/s11033-021-06956-z

Eur J Epidemiol. 2021 Nov 18. doi: 10.1007/s10654-021-00820-x. Online ahead of print.

NO ABSTRACT

PMID:34792692 | DOI:10.1007/s10654-021-00820-x

Clin Transl Oncol. 2021 Nov 18. doi: 10.1007/s12094-021-02729-z. Online ahead of print.

ABSTRACT

PURPOSE: Radiation-induced toxicity (RIT) is usually assessed by inspection and palpation. Due to their subjective and unquantitative nature, objective methods are required. This study aimed to determine whether a quantitative tool is able to assess RIT and establish an underlying BED-response relationship in breast cancer.

METHODS: Patients following seven different breast radiation protocols were recruited to this study for RIT assessment with qualitative and quantitative examination. The biologically equivalent dose (BED) was used to directly compare different radiation regimens. RIT was subjectively evaluated by physicians using the Radiation Therapy Oncology Group (RTOG) late toxicity scores. Simultaneously an objective multiprobe device was also used to quantitatively assess late RIT in terms of erythema, hyperpigmentation, elasticity and skin hydration.

RESULTS: In 194 patients, in terms of the objective measurements, treated breasts showed higher erythema and hyperpigmentation and lower elasticity and hydration than untreated breasts (p < 0.001, p < 0.001, p < 0.001, p = 0.019, respectively). As the BED increased, Δerythema and Δpigmentation gradually increased as well (p = 0.006 and p = 0.002, respectively). Regarding the clinical assessment, the increase in BED resulted in a higher RTOG toxicity grade (p < 0.001). Quantitative assessments were consistent with RTOG scores. As the RTOG toxicity grade increased, the erythema and pigmentation values increased, and the elasticity index decreased (p < 0.001, p = 0.016, p = 0.005, respectively).

CONCLUSIONS: The multiprobe device can be a sensitive and simple tool for research purpose and quantitatively assessing RIT in patients undergoing radiotherapy for breast cancer. Physician-assessed toxicity scores and objective measurements revealed that the BED was positively associated with the severity of RIT.

PMID:34792726 | DOI:10.1007/s12094-021-02729-z

Neurol Sci. 2021 Nov 18. doi: 10.1007/s10072-021-05729-7. Online ahead of print.

ABSTRACT

BACKGROUND: Telephone-based cognitive screening (TBCS) is crucial to telehealth care of neurological patients, prevention campaigns, and epidemiological studies on cognitive impairment. The Telephone Interview for Cognitive Status (TICS) is one of the most widespread and psychometrically/diagnostically sound TBCS test, with several versions developed worldwide (e.g., with and without a delayed recall item). In Italy, only attempts of adaptation and preliminary evidence of its statistical features have been provided so far. This study thus aimed at (1) developing an Italian version of the TICS and assessing its (2) psychometric and (3) diagnostic properties.

METHODS: A back-translated and culturally adapted version of the TICS was developed. Three-hundred and sixty-five healthy individuals from different regions of Italy (147 males, 216 females; age: 53.2 ± 16 years; education: 13 ± 4.5 years) were administered the TICS and the Italian telephone-based Mini-Mental State Examination (Itel-MMSE). Validity was tested by convergence and at the structure level, whereas reliability as internal consistency, test-retest, and inter-rater. Diagnostic accuracy, item difficulty, and discrimination were also examined.

RESULTS: The TICS featured a single component and its score converged with that of the Itel-MMSE (r_s = .37). Reliability was excellent as inter-rater (ICC = .94), good as test-retest (ICC = .78), and acceptable as internal consistency (Cronbach’s α = .63). Accuracy was high as tested against the Itel-MMSE (AUC = .83) and did not improve when adding the delayed recall. Backward subtraction was the most difficult and discriminative task.

DISCUSSION: The Italian TICS is a valid, reliable, and diagnostically accurate TBCS test. The original format of the TICS can be thus adopted in both clinical and research settings.

PMID:34792669 | DOI:10.1007/s10072-021-05729-7

Surg Obes Relat Dis. 2021 Oct 23:S1550-7289(21)00512-8. doi: 10.1016/j.soard.2021.10.014. Online ahead of print.

ABSTRACT

BACKGROUND: Biliopancreatic diversion with duodenal switch (BPD/DS) is a procedure that has long been considered to have a higher early postoperative morbidity than Roux-En-Y gastric bypass (RYGB). However, patients who undergo BPD/DS have more baseline co-morbidities that may affect the reported early postoperative morbidity.

OBJECTIVE: To compare 30-day postoperative morbidity and mortality between BPD/DS and RYGB propensity score-matched cohorts obtained from the MBSAQIP database.

SETTING: Analysis of data obtained from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database.

METHODS: Retrospective analysis of 21-variable propensity score-matched patients in the BPD/DS and RYGB groups obtained from the MBSAQIP database between 2015 and 2019. Variables included age, sex, body mass index, American Society of Anesthesiologists (ASA) class, and pertinent medical co-morbidities. Data were analyzed for 30-day postoperative morbidity, mortality, reoperation, reintervention, and readmissions.

RESULTS: Before matching, RYGB and BPD/DS cohorts contained 134 188 and 5079 patients, respectively. After multivariable propensity score matching, each cohort contained 5050 patients. The RYGB group had a higher rate of surgical-site infections than the BPD/DS group (1% versus .5%, P = .007) and a higher rate of blood product transfusions (1.1% versus .6%, P = .018). The rate of other early postoperative complications was similar between the 2 groups (P > .05). There was no statistically significant difference in the 30-day mortality, readmission rate, reoperation rate, or reintervention rate between the 2 groups (P > .05).

CONCLUSION: When matched for baseline body mass index and co-morbidities, BPD/DS does not lead to a higher 30-day postoperative morbidity and mortality than RYGB. Patients can be counseled that in the short term, BPD/DS is as safe as RYGB.

PMID:34789419 | DOI:10.1016/j.soard.2021.10.014

Intensive Crit Care Nurs. 2021 Oct 28:103160. doi: 10.1016/j.iccn.2021.103160. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the muscle strength and functional level of patients discharged from intensive care unit (ICU) in relation to the swimmer position as a nurse intervention during pronation.

METHODS: Prospective study conducted in the hub COVID-19 center in Milan (Italy), between March and June 2020. All patients with COVID-19 discharged alive from ICU who received invasive mechanical ventilation were included. Forward continuation ratio model was fitted to explore the statistical association between muscle strength grades and body positioning during ICU stay.

RESULTS: Over the 128 patients admitted to ICU, 87 patients were discharged alive from ICU, with available follow-up measures at hospital discharge. Thirty-four patients (39.1%) were treated with prone positioning as rescue therapy, for a total of 106 pronation cycles with a median duration of 72 (IQR 60-83) hours. Prone positioning did not influence the odds of showing particular level of muscle strength, in any of the evaluated districts, namely shoulder (OR 1.34, 95%CI:0.61-2.97), elbow (OR 1.10, 95%CI:0.45-2.68) and wrist (OR 0.97, 95%CI:0.58-1.63). Only in the shoulder district, age showed evidence of association with strength (OR 1.06, 95%CI:1.02-1.10), affecting people as they get older. No significant sequalae related to swimmer position were reported by physiotherapists or nurses.

CONCLUSION: Swimmer position adopted during prone ventilation is not associated with worse upper limb strength or poor mobility level in COVID-19 survivors after hospital discharge.

PMID:34789437 | DOI:10.1016/j.iccn.2021.103160

Spectrochim Acta A Mol Biomol Spectrosc. 2021 Nov 8:120591. doi: 10.1016/j.saa.2021.120591. Online ahead of print.

ABSTRACT

In this study, a facile, rapid, and sensitive spectrofluorimetric method was evolved to analyse two antihypertensive drugs, namely, metolazone (MTZ) and valsartan (VST), in pharmaceutical and biological matrices. Both analytes exhibited intrinsic fluorescence activities which were significantly affected by environmental factors such as pH and solvent systems. However, simultaneous determination of MTZ and VST by conventional spectrofluorometry cannot be achieved simply because of the strong overlap between their fluorescence spectra. Thus, a combination of derivative and synchronous spectrofluorometry was conducted to overcome this dilemma. The proposed method relies on measurement of the first-order derivative of synchronous fluorescence intensity of the studied drugs at Δλ = 160 nm using 0.1 M acetic acid as the optimum solvent. The amplitudes of the first derivative synchronous fluorescence spectra of MTZ and VST were recorded at 236.0 nm (zero-crossing point of VST) and at 262.8 nm (zero-crossing point of MTZ) for simultaneous analysis of MTZ and VST, respectively. The fluorescent method was optimized efficiently to get the maximum selectivity and sensitivity by investigating different solvents, different buffer pHs, and different surfactants. The highest sensitivity and selectivity were achieved when 0.1 M acetic acid was used as a solvent. The method showed a linear concentration range of 10.0-100.0 ng mL^-1 and a limit of detection of <3.0 ng mL^-1 for each analyte. Statistical data analysis confirmed that no significant difference between the proposed spectrofluorometric method and the reference methods. The validity of the proposed spectrofluorometric method approved its suitability for quality control work. The proposed spectrofluorometric method was applied to assay the studied drugs in pharmaceutical dosage and in biological matrices with acceptable %recoveries and small RSD values.

PMID:34789407 | DOI:10.1016/j.saa.2021.120591

Eur Urol. 2021 Nov 14:S0302-2838(21)02117-5. doi: 10.1016/j.eururo.2021.10.016. Online ahead of print.

ABSTRACT

BACKGROUND: The taxanes docetaxel and cabazitaxel prolong overall survival for men with metastatic castration-resistant prostate cancer (mCRPC), with cabazitaxel approved in the postdocetaxel setting only. Recent data suggest they have similar efficacy but a different safety profile in the first-line mCRPC setting.

OBJECTIVE: To assess patient preference between docetaxel and cabazitaxel among men who received one or more doses of each taxane and did not experience progression after the first taxane.

DESIGN, SETTING, AND PARTICIPANTS: Chemotherapy-naïve patients with mCRPC were randomized 1:1 to receive docetaxel (75 mg/m² every 3 wk × 4 cycles) followed by cabazitaxel (25 mg/m² every 3 wk × 4 cycles) or the reverse sequence. Randomization was stratified by prior abiraterone or enzalutamide use.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was patient preference, assessed via a dedicated questionnaire after the second taxane. Secondary endpoints included reasons for patient preference, prostate-specific antigen response, radiological progression-free survival, and overall survival. This clinical trial is registered at ClinicalTrials.gov as NCT02044354.

RESULTS AND LIMITATIONS: Of 195 men randomized, 152 met the prespecified modified intent-to-treat criteria for analysis. Overall, 66 patients (43%) preferred cabazitaxel, 40 (27%) preferred docetaxel, and 46 (30%) had no preference (p = 0.004, adjusted for treatment period effect). More patients preferred treatment period 1 (43%, 95% confidence interval [CI] 36-52%) versus period 2 (27%, 95% CI 20-34%). Patient preference for cabazitaxel was mainly related to less fatigue (72%), better quality of life (64%), and other adverse events (hair loss, pain, nail disorders, edema). Adverse events were consistent with the known safety profile of each drug.

CONCLUSIONS: A significantly higher proportion of chemotherapy-naïve men with mCRPC who received both taxanes preferred cabazitaxel over docetaxel. Less fatigue and better quality of life were the two main reasons driving patient choice.

PATIENT SUMMARY: Men with metastatic castration-resistant prostate cancer preferred cabazitaxel over docetaxel for chemotherapy, mainly because of less fatigue and better quality of life.

PMID:34789394 | DOI:10.1016/j.eururo.2021.10.016

J Am Pharm Assoc (2003). 2021 Nov 2:S1544-3191(21)00448-9. doi: 10.1016/j.japh.2021.10.029. Online ahead of print.

ABSTRACT

BACKGROUND: Students in health professions, including student pharmacist, are at an increased risk of psychological distress. Unfortunately, effective efforts to combat burnout for student pharmacists are still lacking in the literature and create a void in schools and colleges of pharmacy that seek to assist their students.

OBJECTIVES: The objective of this study was to explore how increasing positive out-of-class interactions between the student pharmacists and faculty members affect burnout, especially in work exhaustion and interpersonal disengagement. Professional fulfillment was also assessed as a primary outcome.

METHODS: The institutional review board approved this study consisting of 4 faculty members and 12 students. After providing informed consent, the participants were assigned to one of 4 groups. Each group included 1 faculty member and 3 students. At the start of the study, each participant completed a modified Stanford Professional Fulfillment Index questionnaire to measure baseline burnout characteristics and initial level of professional fulfillment. For 8 weeks, the groups met weekly to discuss a topic related to burnout and professional fulfillment. After 8 weeks, each participant completed the postquestionnaire. Wilcoxon signed-rank tests were performed to the mean scores (pre vs. post) in each of the 3 constructs. The statistical significance was set at P < 0.05.

RESULTS: The results of the Wilcoxon signed-rank analysis showed a statistically significant difference in the burnout constructs, work exhaustion and interpersonal disengagement. There was not a statistically significant change in professional fulfillment.

CONCLUSIONS: Improving relationships between student pharmacist and faculty through increasing out-of-class interactions benefits individuals who are at risk of experiencing burnout. Future initiatives can focus on effective strategies that target work exhaustion and interpersonal disengagement and build on the social networks that develop in pharmacy school.

PMID:34789404 | DOI:10.1016/j.japh.2021.10.029

Eur Urol. 2021 Nov 14:S0302-2838(21)02133-3. doi: 10.1016/j.eururo.2021.10.030. Online ahead of print.

ABSTRACT

BACKGROUND: It is hypothesised that simulation enhances progression along the initial phase of the surgical learning curve.

OBJECTIVE: To evaluate whether residents undergoing additional simulation, compared to conventional training, are able to achieve proficiency sooner with better patient outcomes.

DESIGN, SETTING, AND PARTICIPANTS: This international, multicentre, randomised controlled trial recruited 94 urology residents with experience of zero to ten procedures and no prior exposure to simulation in ureterorenoscopy, selected as an index procedure.

INTERVENTION: Participants were randomised to simulation or conventional operating room training, as is the current standard globally, and followed for 25 procedures or over 18 mo.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The number of procedures required to achieve proficiency, defined as achieving a score of ≥28 on the Objective Structured Assessment of Technical Skill (OSATS) scale over three consecutive operations, was measured. Surgical complications were evaluated as a key secondary outcome. This trial is registered at www.isrctn.com as ISCRTN 12260261.

RESULTS AND LIMITATIONS: A total of 1140 cases were performed by 65 participants, with proficiency achieved by 21 simulation and 18 conventional participants over a median of eight and nine procedures, respectively (hazard ratio [HR] 1.41, 95% confidence interval [CI] 0.72-2.75). More participants reached proficiency in the simulation arm in flexible ureterorenoscopy, requiring a lower number of procedures (HR 0.89, 95% CI 0.39-2.02). Significant differences were observed in overall comparison of OSATS scores between the groups (mean difference 1.42, 95% CI 0.91-1.92; p < 0.001), with fewer total complications (15 vs 37; p = 0.003) and ureteric injuries (3 vs 9; p < 0.001) in the simulation group.

CONCLUSIONS: Although the number of procedures required to reach proficiency was similar, simulation-based training led to higher overall proficiency scores than for conventional training. Fewer procedures were required to achieve proficiency in the complex form of the index procedure, with fewer serious complications overall.

PATIENT SUMMARY: This study investigated the effect of simulation training in junior surgeons and found that it may improve performance in real operating settings and reduce surgical complications for complex procedures.

PMID:34789393 | DOI:10.1016/j.eururo.2021.10.030