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Nevin Manimala Statistics

The Diagnostic Role of Shear Wave Elastography and Superb Microvascular Imaging in the Evaluation of Suspicious Microcalcifications

J Ultrasound Med. 2023 May 5. doi: 10.1002/jum.16252. Online ahead of print.

ABSTRACT

OBJECTIVES: The aim of this study was to investigate the role of superb microvascular imaging (SMI) and shear wave elastography (SWE) in the prediction of malignancy and invasiveness of isolated microcalcifications (MC) that can be visualized by ultrasonography (US).

MATERIAL AND METHODS: Sixty-seven women with MC, who were considered suspicious on mammography were evaluated. Only those lesions that could be visualized by US and presented as non-mass lesion were included. They were evaluated by B-mode US, SMI, and SWE before US-guided core-needle biopsy. B-mode US, SMI (vascular index (SMIvi)), and SWE (E-mean, E-ratio) findings were compared with histopathologic features.

RESULTS: Pathology confirmed 45 malignant (21 invasive and 24 in situ carcinomas) and 22 benign lesions. There was a statistically significant difference between malignant and benign groups in terms of size (P = .015), distortion (P = .028), cystic component (P < .001), E-mean (P < .001), E-ratio (P < .001), and SMIvi (P = .006). For differentiation of invasiveness E-mean (P = .002), E-ratio (P = .002), and SMIvi (P = .030) were statistically significant. According to ROC analysis E-mean (cut-off point at 38 kPa) was the most sensitive (78%) and the most specific (95%) value among four numeric parameters (size, SMI, E-mean, and E-ratio) with AUC = 0.895, PPV = 97%, and NPV = 68% in detecting malignancy. In the evaluation of invasiveness, the most sensitive (71.4%) method was SMI (cut-off point at 3.4) and the most specific (72%) method was E-mean (cut-off point at 91.5 kPa).

CONCLUSION: Our study shows that adding SWE and SMI to the sonographic evaluation of MC would be an advantage for US-guided biopsy. Including suspicious areas according to SMI and SWE in the sampling area can help target the invasive part of the lesion and avoid underestimation of core biopsy.

PMID:37146224 | DOI:10.1002/jum.16252

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Evaluation of Risk Factors for Malignancy Obtained by Means of Fine Needle Aspiration Biopsies in Thyroid Nodules and Surgical Outcomes of Patients with Bethesda Category III (AUS/FLUS)

Chirurgia (Bucur). 2023 Apr;118(2):137-145. doi: 10.21614/chirurgia.2812.

ABSTRACT

Background: The nodules diagnosed as the “atypia of undetermined significance” category are a heterogenous group with an indeterminate risk of malignancy. This study aimed to perform a detailed cytological examination of the preparations to determine the cytomorphological criteria that may be useful to distinguish benign cases from malignant ones, correlate them with ultrasonographic findings, and compare them with the final pathological result in surgically treated patients. Methods: The preparations of patients classified as Bethesda 3 were re-evaluated; presence or absence of one of 11 parameters (hypochromasia, oval nucleus, colloid, intra-nuclear pseudoinclusions, nuclear grooving, nuclear moldering, isolated nuclear enlargement, nuclear irregularity, nuclear size, microfollicular pattern, distinct nucleoli) and correlating with surgical outcomes by adding ultrasonographic findings to statistically significant parameters. Results: Two hundred and six fine needle aspirations (FNA) procedures were classified as Bethesda 3. A total of 53 patients underwent surgery; 28 (52.8%) of them were benign, and 25 (47.1%) were malignant. Thirty-two (15.5%) accepted direct surgery; 53 patients underwent repeat FNA at 3-6 month intervals and those with malignancy and repeated Bethesda 3 interpretation were operated. One hundred twenty-one (69.5%) patients who did not undergo biopsy were invited for ultrasonographic controls at 3-6 month intervals. Among the 11 cytomorphologic parameters evaluated, 7 were found to be statistically significant (p 0.05) with malignancy. When at least 3 of these parameters were positive, the malignancy rate was 92%. Malignancy was present in 19 (61.3%) of the patients with high risk nodules (TIRADS = 4), compared to only 6 (35.8%) of the low-risk (TIRADS = 3); there was a significant correlation between the presence of malignancy and TIRADS score (p=0.015). The preparations that displayed nucleus atypia were closely associated with the ultrasonographically high-risk group. Conclusion: The parameters indicating nuclear atypia, presence of more than 3 cytomorphological factors, TIRADS score 4 were significantly associated with malignancy; nuclear atypia were closely associated with the ultrasonographically high TIRADS. No significant correlation was found between the presence of “microfollicular pattern” and malignancy.

PMID:37146190 | DOI:10.21614/chirurgia.2812

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Nevin Manimala Statistics

Evolution of primary care telehealth disparities during COVID-19: a retrospective cohort study

J Med Internet Res. 2023 Jan 26. doi: 10.2196/43965. Online ahead of print.

ABSTRACT

BACKGROUND: Telehealth has become widely utilized as a novel way to provide outpatient care during the coronavirus disease (COVID-19) pandemic, but data about telehealth use in primary care remains limited. Studies in other specialties raise concerns that telehealth may be widening existing healthcare disparities, requiring further scrutiny of trends in telehealth utilization.

OBJECTIVE: Our study aims to further characterize sociodemographic differences in primary care utilization via telehealth compared to in-person office visits before and during the COVID-19 pandemic, and determine if these disparities changed throughout 2020.

METHODS: We conducted a retrospective cohort study in a large U.S. academic center with 46 primary care practices from April-December 2019 and April-December 2020. Data were subdivided into calendar quarters and compared to determine evolving disparities throughout the year. We queried and compared billed outpatient encounters in General Internal Medicine and Family Medicine via binary logic mixed effects regression model and estimated odds ratios with 95% confidence intervals (OR, 95% CI). We used sex, race, and ethnicity of the patient attending each encounter as fixed effects. We analyzed socioeconomic status of patients in the institution’s primary county based on the zip code the patient was residing in.

RESULTS: A total of 81,822 encounters in the pre-COVID-19 timeframe and 47,994 encounters in the intra-COVID-19 timeframe were analyzed; in the intra-COVID-19 timeframe, a total of 5,322 (11.1%) were telehealth encounters. Patients living in zip codes with high supplemental nutritional assistance usage were less likely to utilize primary care in the intra-COVID-19 timeframe (OR 0.94, 95% CI 0.90-0.98, P= .006). Encounters with the following patients were less likely to be via telehealth compared to in-person office visits- patients who self-identified as Asian (OR 0.74, 95% CI 0.63-0.86) and Nepali (OR 0.37, 95% CI 0.19-0.72), patients insured by Medicare (OR 0.77, 95% CI 0.68-0.88), and patients living in zip codes with high supplemental nutritional assistance usage (OR 0.84, 95% CI 0.71-0.99). Many of these disparities persisted throughout the year. While there was no statistically significant difference in telehealth utilization for patients insured by Medicaid throughout the whole year, sub analysis of quarter 4 found encounters with patients insured by Medicaid were less likely to be via telehealth (OR 0.73, 95% CI 0.55-0.97, P=.03).

CONCLUSIONS: Telehealth was not utilized equally by all patients within primary care throughout the first year of the COVID-19 pandemic, specifically by patients who self-identified as Asian and Nepali, were insured by Medicare, and lived in zip codes with low socioeconomic status. As the COVID-19 pandemic and telehealth infrastructure change, it is critical we continue to reassess the utilization of telehealth. Institutions should continue to monitor disparities in telehealth access, and advocate for policy changes that may improve equity.

PMID:37146176 | DOI:10.2196/43965

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Reduced metabolic flexibility is a predictor of weight gain among liver transplant recipients

Liver Transpl. 2023 May 8. doi: 10.1097/LVT.0000000000000169. Online ahead of print.

ABSTRACT

BACKGROUND: Metabolic flexibility is the ability to match biofuel availability to utilization and is inversely associated with increased metabolic burden among liver transplant (LT) recipients. The present study evaluated the impact of metabolic flexibility on weight gain following LT.

METHODS: LT recipients were enrolled prospectively (n = 47) and followed for 6 months. Metabolic flexibility was measured using whole room calorimetry and is expressed as respiratory quotient (RQ). Peak RQ represents maximal carbohydrate metabolism and occurs in the post-prandial state, while trough RQ represents maximal fatty acid metabolism occurring in the fasted state.

RESULTS: The clinical, metabolic and laboratory characteristics of the study cohort of lost weight (n = 14) and gained weight (n = 33) were similar at baseline. Patients who lost weight were more likely to reach maximal RQ (maximal carbohydrate oxidation) early and rapidly transitioned to trough RQ (maximal fatty acid oxidation). In contrast, patients who gained weight had delayed time to peak RQ and trough RQ. In multivariate modeling, time to peak RQ (β-coefficient 0.509, p = 0.01), time from peak RQ to trough RQ (β-coefficient 0.634, p = 0.006), and interaction between time to peak RQ to trough RQ and fasting RQ (β-coefficient 0.447, p = 0.02) directly correlated with severity of weight gain. No statistically significant relationship between peak RQ, trough RQ and weight change was demonstrated.

CONCLUSION: Inefficient transition between biofuels (carbohydrates and fatty acids) is associated with weight gain in LT recipients that is independent of clinical metabolic risk. These data offer novel insight into the physiology of obesity post-LT with potential to develop new diagnostics and therapeutics.

PMID:37146168 | DOI:10.1097/LVT.0000000000000169

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Chemometrics in Protein Formulation: Stability Governed by Repulsion and Protein Unfolding

Mol Pharm. 2023 May 5. doi: 10.1021/acs.molpharmaceut.3c00013. Online ahead of print.

ABSTRACT

Therapeutic proteins can be challenging to develop due to their complexity and the requirement of an acceptable formulation to ensure patient safety and efficacy. To date, there is no universal formulation development strategy that can identify optimal formulation conditions for all types of proteins in a fast and reliable manner. In this work, high-throughput characterization, employing a toolbox of five techniques, was performed on 14 structurally different proteins formulated in 6 different buffer conditions and in the presence of 4 different excipients. Multivariate data analysis and chemometrics were used to analyze the data in an unbiased way. First, observed changes in stability were primarily determined by the individual protein. Second, pH and ionic strength are the two most important factors determining the physical stability of proteins, where there exists a significant statistical interaction between protein and pH/ionic strength. Additionally, we developed prediction methods by partial least-squares regression. Colloidal stability indicators are important for prediction of real-time stability, while conformational stability indicators are important for prediction of stability under accelerated stress conditions at 40 °C. In order to predict real-time storage stability, protein-protein repulsion and the initial monomer fraction are the most important properties to monitor.

PMID:37146162 | DOI:10.1021/acs.molpharmaceut.3c00013

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Nevin Manimala Statistics

Supported Intervention Versus Intervention Alone for Management of Fecal Incontinence in Patients With Inflammatory Bowel Disease: A Multicenter Mixed-Methods Randomized Controlled Trial

J Wound Ostomy Continence Nurs. 2023 May-Jun 01;50(3):235-244. doi: 10.1097/WON.0000000000000979.

ABSTRACT

PURPOSE: The aims of this study were to test a noninvasive self-management intervention supported by specialist nurses versus intervention alone in patients with inflammatory bowel disease (IBD) experiencing fecal incontinence and to conduct a qualitative evaluation of the trial.

DESIGN: Multicenter, parallel-group, open-label, mixed-methods randomized controlled trial (RCT).

SUBJECTS AND SETTING: The sample comprised patients from a preceding case-finding study who reported fecal incontinence and met study requirements; the RCT was delivered via IBD outpatient clinics in 6 hospitals (5 in major UK cities, 1 rural) between September 2015 and August 2017. Sixteen participants and 11 staff members were interviewed for qualitative evaluation.

METHODS: Adults with IBD completed the study activities over a 3-month period following randomization. Each participant received either four 30-minute structured sessions with an IBD clinical nurse specialist and a self-management booklet or the booklet alone. Low retention numbers precluded statistical analysis; individual face-to-face or telephone interviews, recorded digitally and transcribed professionally, were conducted to evaluate the RCT. Transcripts were analyzed thematically using an inductive method.

RESULTS: Sixty-seven participants (36%) of the targeted 186 participants were recruited. The groups comprised 32 participants (17% of targeted participants) allocated to the nurse + booklet intervention and 35 (18.8% of targeted participants) allocated to the booklet alone. Less than one-third (n = 21, 31.3%) completed the study. Given the low recruitment and high attrition, statistical analysis of quantitative data was considered futile. Participant interviews were conducted concerning study participation and 4 themes emerged that described experiences of patients and staff. These data provided insights into reasons for low recruitment and high attrition, as well as challenges of delivering resource-heavy studies in busy health service environments.

CONCLUSIONS: Alternative approaches to trials of nurse-led interventions in hospital settings are needed as many interfering factors may prevent successful completion.

PMID:37146115 | DOI:10.1097/WON.0000000000000979

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Ostomy-Related Quality of Life in Puerto Ricans Living With Inflammatory Bowel Disease: A Prospective Cohort Study

J Wound Ostomy Continence Nurs. 2023 May-Jun 01;50(3):222-226. doi: 10.1097/WON.0000000000000964.

ABSTRACT

PURPOSE: The aim of this study was to determine ostomy-related quality of life (QOL) in Hispanic Puerto Ricans living with an enteral stoma and inflammatory bowel disease (IBD). We analyzed possible associations between QOL and sex, diagnosis, and type and duration of stoma.

DESIGN: Prospective cohort study.

SUBJECTS AND SETTINGS: The sample comprised 102 adults living with IBD and an ostomy; 60 of 101 (59.4%) were males, 44 of 102 (43.1%) had Crohn’s disease, and 60 of 102 (58.9%) had an ileostomy. Participants were receiving care at the Center for IBD of the University of Puerto Rico in San Juan, Puerto Rico, between January 2012 and December 2014.

METHODS: One-hundred two adults Puerto Ricans with IBD completed the Stoma Quality of Life (Stoma-QOL) questionnaire. Data were analyzed using frequency distributions for categorical variables and summary statistics for continuous variables. Independent-group t test and one-way analysis of variance, with the post hoc Tukey test, were used to determine group differences for the variables of age, sex, civil status, time living with an ostomy, type of ostomy, and IBD diagnosis. Results were analyzed according to the number of responses to each variable; the denominator varied for some variables.

RESULTS: Having an ostomy for more than 40 months was significantly associated with a higher QOL score (59.0 vs 50.7; P = .05). Males had significantly higher scores than females (59.94 vs 50.23; P = .0019). Age, IBD diagnosis, and type of ostomy were not associated with the Stoma-QOL scores.

CONCLUSIONS: The achievement (over 40 months) to attain improved ostomy-related QOL suggests that early training in the care of the ostomy and advanced planning when leaving home may enhance ostomy-related QOL. Lower QOL in women may represent an opportunity for a sex-specific educational intervention.

PMID:37146114 | DOI:10.1097/WON.0000000000000964

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Incidence and Predictive Model of Medical Adhesive-Related Skin Injury in Cancer Patients Managed With Central Venous Access Devices: A Retrospective Study

J Wound Ostomy Continence Nurs. 2023 May-Jun 01;50(3):209-213. doi: 10.1097/WON.0000000000000971.

ABSTRACT

PURPOSE: The purpose of this study was to determine the prevalence of medical adhesive-related skin injury (MARSI) at the site of central venous access device (CVAD) implantation in patients with cancer, identify risk factors associated with MARSI in patients with cancer, and create a nomogram for predicting risk of MARSI.

DESIGN: Retrospective, single-center study.

SUBJECTS AND SETTING: The sample comprised 1172 consecutive patients who underwent CVAD implantation between February 2018 and February 2019; their mean age was 55.7 years (SD: 13.9). Data were collected at the First Affiliated Hospital of Xi’an Jiaotong University, located in Xi’an, China.

METHODS: Demographic and pertinent clinical data were collected from patient records. Routine dressing changes were performed every 7 days for peripherally inserted central venous catheters (PICCs) or 28 days for ports except in patients with existing skin injuries. Skin injuries related to use of medical adhesives and persisting for more than for 30 minutes were classified MARSI. Data were used to develop a nomogram for predicting MARSI. The accuracy of the nomogram was verified by calculating the concordance index (C-index) and drawing a calibration curve.

RESULTS: Among the 1172 patients, 330 (28.2%) had undergone PICC implantation, and 282 (24.1%) experienced 1 or more MARSIs representing an incidence rate of 1.7 events per 1000 CVAD days. Statistical analysis identified previous MARSI history, the need for total parenteral nutrition support, other catheter-related complications, a history of allergy, and PICC implantation as associated with a higher likelihood of developing for MARSI. Based on these factors, we established a nomogram for predicting the risk of developing MARSI in patients with cancer who underwent CVAD implantation. The C-index of the nomogram was 0.96, and the calibration curve of the nomogram showed that the predictive ability of the nomogram was strong.

CONCLUSIONS: We evaluated patients with cancer who were undergoing CVAD and identified that previous MARSI history, patients needing total parenteral nutrition support, other catheter-related complications, allergic history, and PICC implantation (compared with ports) were associated with a higher likelihood for developing MARSI. The nomogram we developed showed a good ability for predicting the risk of developing MARSI and may assist nurses to predict MARSI in this population.

PMID:37146111 | DOI:10.1097/WON.0000000000000971

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Predictors of Relevant Changes in Pain and Function for Adolescents with Idiopathic Scoliosis following Surgery

Spine (Phila Pa 1976). 2023 May 5. doi: 10.1097/BRS.0000000000004705. Online ahead of print.

ABSTRACT

STUDY DESIGN: Retrospective analysis of longitudinal data.

OBJECTIVE: To evaluate clinically relevant change in surgical outcomes for Adolescents with Idiopathic Scoliosis (AIS), comparing those who achieved smallest detectable change (SDC) in pain and function at 1-year post-surgery and those who did not, and to evaluate the influencing factors.

SUMMARY OF BACKGROUND DATA: The SDC is recommended to evaluate the surgical outcomes of AIS. However, little is known about the use of SDC in AIS and its influencing factors.

METHODS: This was a retrospective analysis of longitudinal data from patients who underwent surgical correction at a tertiary spinal centre from to 2009-2019. Surgical outcomes were assessed at short-term (6 wk, 6 mo) and long-term (1- and 2-years) post-surgery using the Scoliosis Research Society (SRS-22r). The difference between ‘successful’ (≥ SDC) and ‘unsuccessful’ (< SDC) groups was assessed using an independent t-test. Univariate and logistic regression analyses enabled the assessment of influencing factors.

RESULTS: All SRS-22r domains decreased in the short term, except for self-image and satisfaction. In the long term, self-image increased by 1.21 and function increased by 0.2, and pain decreased by 0.1. In all SRS-22r domains ‘successful’ group had low pre-surgery scores and were statistically different to the ‘unsuccessful group’. The difference remained statistically significant at 1-year for most SRS-22r domains. Being older and having low pre-surgery SRS-22r scores increased the chances of achieving SDC function at 1-year. Achieving SDC in the pain domain was significantly associated with age, sex, length of hospital stay, and pre-surgical scores.

CONCLUSION: Notably, the self-image domain showed the largest change compared to other SRS-22r domains. A low preoperative score increases the likelihood of clinical benefit from surgery. These findings demonstrate the utility of SDC for assessing the benefits and factors that may underpin surgical benefit in AIS.

PMID:37146097 | DOI:10.1097/BRS.0000000000004705

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A unitary mechanism underlies adaptation to both local and global environmental statistics in time perception

PLoS Comput Biol. 2023 May 5;19(5):e1011116. doi: 10.1371/journal.pcbi.1011116. Online ahead of print.

ABSTRACT

Our duration estimation flexibly adapts to the statistical properties of the temporal context. Humans and non-human species exhibit a perceptual bias towards the mean of durations previously observed as well as serial dependence, a perceptual bias towards the duration of recently processed events. Here we asked whether those two phenomena arise from a unitary mechanism or reflect the operation of two distinct systems that adapt separately to the global and local statistics of the environment. We employed a set of duration reproduction tasks in which the target duration was sampled from distributions with different variances and means. The central tendency and serial dependence biases were jointly modulated by the range and the variance of the prior, and these effects were well-captured by a unitary mechanism model in which temporal expectancies are updated after each trial based on perceptual observations. Alternative models that assume separate mechanisms for global and local contextual effects failed to capture the empirical results.

PMID:37146089 | DOI:10.1371/journal.pcbi.1011116