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Nevin Manimala Statistics

Clinical Observations in Patients With Cystic Fibrosis-Related Diabetes and Self-Reported Ototoxicity Symptoms

Am J Audiol. 2023 Nov 28:1-9. doi: 10.1044/2023_AJA-22-00237. Online ahead of print.

ABSTRACT

PURPOSE: Persons with cystic fibrosis (PwCF) are at high risk for ototoxicity due to the routine use of intravenous aminoglycoside (IV-AG) antibiotics in respiratory infection management. Additionally, factors that contribute to ototoxicity-related symptom development and severity in PwCF are unknown. Given the increased risk of ototoxicity in people with diabetes, we explored the association between cystic fibrosis-related diabetes (CFRD) and self-reported ototoxicity symptoms (tinnitus and vestibular problems) in PwCF treated with aminoglycosides.

METHOD: PwCF (N = 39; 25 females, 14 males; Mage = 30.1 years, SD = 10.3) were recruited from the Cystic Fibrosis Care Center at Oregon Health & Science University. Patients completed the validated questionnaires to ascertain their experiences with ototoxicity-related symptoms of tinnitus and balance function. The diagnosis of CFRD, including oral glucose tolerance testing (OGTT), insulin treatment, hemoglobin A1c, and cumulative IV-AG treatment history, was obtained through a medical chart review. Participants were classified into three groups based on their medical diagnoses via OGTT: normal glucose tolerance (NGT; control; n = 16), abnormal glucose tolerance (AGT; n = 9), and CFRD (n = 14). Participants in each group were further classified based on survey outcomes for ototoxicity-related symptoms.

RESULTS: There was a trend toward a higher proportion of patients with CFRD reporting tinnitus compared to the AGT and NGT groups, but did not meet statistical significance (X2 = 2.24, p = .13). Approximately, 43% of patients with CFRD reported experiencing clinically significant tinnitus lasting > 3 min compared to 11% in the AGT group and 13% in the NGT group (X2 = 3.751, p = .05). Cumulative IV-AG exposure tended to be higher in CFRD compared to other groups. High balance function was generally reported in all groups.

CONCLUSIONS: Patients with CFRD have greater ototoxicity-related symptoms. Further investigation of the relationship between CF-related comorbidities and the risk of developing ototoxicity-related symptoms is warranted to improve the detection and management of ototoxicity in PwCF.

PMID:38016170 | DOI:10.1044/2023_AJA-22-00237

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Analysis of life quality on patients with thoracolumbar fractures

Rev Med Inst Mex Seguro Soc. 2023 Sep 18;61(Suppl 2):S289-S294.

ABSTRACT

BACKGROUND: Patients with thoracolumbar fractures with TLICS 4 classification are at the limit of surgical fixation with regards to conservative treatment; however, results in our environment are not known, which is why this study has innovative characteristics.

OBJECTIVE: To determine the quality of life in patients with TLICS 4 thoracolumbar fractures using traditional fixation with regards to no fixation in a third level hospital.

MATERIAL AND METHODS: A cohort prospective study was carried out in patients with TLICS 4 classification thoracolumbar fractures using traditional fixation with regards to no fixation in beneficiaries from the Mexican Institute for Social Security. The SF-12 instrument, which assessed quality of life, was administered; age, sex, days of hospitalization, time of spinal cord injury were searched in the patients’ medical history. It was used descriptive and inferential statistics using Student’s t or Mann-Whitney U.

RESULTS: 20 patients participated and 9 had traditional fixation (45%). All patients had type E spinal cord injuries according to the International Standards for Neurological Classification of Spinal Cord Injury. Mean age of non-fixation was 42.2 ± 12.9 and of fixation 44.9 ± 10.2; in non-fixation 6 (67%) were male. The quality of life score was 29.1 ± 0.9 in the conservative treatment and 28.7 ± 1.3 in the surgical treatment, p < 0.462.

CONCLUSIONS: No differences in quality of life were observed in patients with TLICS 4 thoracolumbar fractures using traditional fixation with regards to no fixation.

PMID:38016168

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The association between reproductive period and handgrip strength in postmenopausal women: a nationwide cross-sectional study

Menopause. 2023 Nov 28. doi: 10.1097/GME.0000000000002283. Online ahead of print.

ABSTRACT

OBJECTIVE: Menarche and menopause are associated with muscle loss and strength in women. Handgrip strength (HGS) is a reliable measurement method of muscle strength. However, it is unclear whether the entire reproductive period, which encompasses both menarche and menopause, is associated with HGS in postmenopausal women.

METHODS: A total of 2,354 postmenopausal women aged 45-75 years were included for statistical analysis. The reproductive period was divided into tertiles, and HGS was divided into four quartiles. HGS was measured to evaluate muscle strength. Binary logistic regression analysis was used to identify significant predictors with the first quartile HGS, derived from quartile data. Multiple logistic regression analysis was used to assess the relationship between the reproductive period (exposure) and low HGS (outcome).

RESULTS: We found that the more extended the reproductive period, the lower the risk of low absolute HGS. This trend persisted even after controlling for other variables. Specifically, the odds ratio for low absolute HGS was 0.752 (95% confidence interval [CI], 0.563-1.000) for the second tertile reproductive period and 0.683 (95% CI, 0.513-0.900) for the third tertile reproductive period, with the first tertile reproductive period as the reference. The odds ratio for low relative HGS was 0.761 (95% CI, 0.551-1.052) for the second tertile reproductive period and 0.732 (95% CI, 0.533-0.972) for the third tertile reproductive period, using first tertile reproductive period as the reference, after covariate adjustment.

CONCLUSIONS: A longer reproductive period is associated with a decreased risk of low HGS in postmenopausal women.

PMID:38016167 | DOI:10.1097/GME.0000000000002283

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Systematic review and network meta-analysis comparing the efficacy of fezolinetant with hormone and nonhormone therapies for treatment of vasomotor symptoms due to menopause

Menopause. 2023 Nov 28. doi: 10.1097/GME.0000000000002281. Online ahead of print.

ABSTRACT

IMPORTANCE: The neurokinin 3 receptor antagonist fezolinetant 45 mg/d significantly reduced frequency/severity of moderate to severe vasomotor symptoms (VMS) of menopause compared with placebo in two phase 3 randomized controlled trials. Its efficacy relative to available therapies is unknown.

OBJECTIVE: We conducted a systematic review and Bayesian network meta-analysis to compare efficacy with fezolinetant 45 mg and hormone therapy (HT) and non-HT for VMS in postmenopausal women.

EVIDENCE REVIEW: Using OvidSP, we systematically searched multiple databases for phase 3 or 4 randomized controlled trials in postmenopausal women with ≥7 moderate to severe VMS per day or ≥50 VMS per week published/presented in English through June 25, 2021. Mean change in frequency and severity of moderate to severe VMS from baseline to week 12 and proportion of women with ≥75% reduction in VMS frequency at week 12 were assessed using fixed-effect models.

FINDINGS: The network meta-analysis included data from the pooled phase 3 fezolinetant trials plus 23 comparator publications across the outcomes analyzed (frequency, 19 [34 regimens]; severity, 6 [7 regimens]; ≥75% response, 9 [15 regimens]). Changes in VMS frequency did not differ significantly between fezolinetant 45 mg and any of the 27 HT regimens studied. Fezolinetant 45 mg reduced the frequency of moderate to severe VMS events per day significantly more than all non-HTs evaluated: paroxetine 7.5 mg (mean difference [95% credible interval {CrI}], 1.66 [0.63-2.71]), desvenlafaxine 50 to 200 mg (mean differences [95% CrI], 1.12 [0.10-2.13] to 2.16 [0.90-3.40]), and gabapentin ER 1800 mg (mean difference [95% CrI], 1.63 [0.48-2.81]), and significantly more than placebo (mean difference, 2.78 [95% CrI], 1.93-3.62]). Tibolone 2.5 mg (the only HT regimen evaluable for severity) significantly reduced VMS severity compared with fezolinetant 45 mg. Fezolinetant 45 mg significantly reduced VMS severity compared with desvenlafaxine 50 mg and placebo and did not differ significantly from higher desvenlafaxine doses or gabapentin ER 1800 mg. For ≥75% responder rates, fezolinetant 45 mg was less effective than tibolone 2.5 mg (not available in the United States) and conjugated estrogens 0.625 mg/bazedoxifene 20 mg (available only as 0.45 mg/20 mg in the United States), did not differ significantly from other non-HT regimens studied and was superior to desvenlafaxine 50 mg and placebo.

CONCLUSIONS: The only HT regimens that showed significantly greater efficacy than fezolinetant 45 mg on any of the outcomes analyzed are not available in the United States. Fezolinetant 45 mg once daily was statistically significantly more effective than other non-HTs in reducing the frequency of moderate to severe VMS.

RELEVANCE: These findings may inform decision making with regard to the individualized management of bothersome VMS due to menopause.

PMID:38016166 | DOI:10.1097/GME.0000000000002281

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Successes of a Focused Mothers’ Own Milk (MOM) Program in Counteracting Unintended Effects of a Donor Milk Program on MOM Rates at Discharge

Breastfeed Med. 2023 Nov 29. doi: 10.1089/bfm.2023.0147. Online ahead of print.

ABSTRACT

Background: Avoidance of early formula feeding (EFF) and advancement of mother’s own milk (MOM) in very low birth weight (VLBW) infants are important health influencers to decrease serious morbidities. Objective: To present the challenges and feeding strategy successes implemented to counteract a decline in MOM at discharge after initiation of donor milk (DM) to avoid EFF in racially and ethnically diverse VLBW infants. Patients and Methods: Retrospective review of prospectively tracked inborn surviving VLBW infants and their mothers admitted to neonatal intensive care unit from 2010 to 2020 during three feeding strategy implementations baby friendly (BF), DM program, and MOM bundle. Analysis included type of feeding (MOM, DM, or formula) and maternal with descriptive and comparative statistical analysis as indicated. Results: Analysis included 616 VLBW infants. Initiation of BF program resulted in 58.5% of infants discharged on MOM with 41.5% exposed to EFF. Initiation of the DM program resulted in a decline in EFF to 5% and decline in MOM at discharge to 26%. MOM bundle strategy resulted in an increase in MOM at discharge to 41% with sustained EFF exposure 0%. MOM at discharge varied among maternal racial and ethnic backgrounds in all epochs. Early DM use was not different among mothers by race or ethnicity with DM by African American (AA) mothers 89% > White mothers 83% > Other/Hispanic mothers 75%. MOM at discharge was lowest for AA mothers 33% < Hispanic mothers 40% < White mothers 55% < Asian/Other mothers at 60%. Conclusion: Changes in VLBW feeding strategies to avoid EFF utilizing DM can be successful among diverse maternal racial and ethnic populations. Nursing and maternal education coupled with early lactation support and attention to maternal individual long-term feeding plans were critical to improve MOM at discharge among mothers of all racial-ethnic backgrounds for successful attainment of MOM utilization in term corrected VLBW infants at discharge.

PMID:38016149 | DOI:10.1089/bfm.2023.0147

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Post-surgical hip complications in patients with and without a history of COVID-19

Rev Med Inst Mex Seguro Soc. 2023 Sep 18;61(Suppl 2):S275-S281.

ABSTRACT

BACKGROUND: The World Health Organization (WHO) declared COVID-19 a pandemic on March 11, 2020. Patients who tested positive for COVID-19 experienced a higher overall rate of post-surgical complications and hospital mortality.

OBJECTIVE: To compare the asociation of post-surgical complications presented in post-surgical hip patients with and without history of COVID-19 infection.

MATERIAL AND METHODS: Prospective cohort study. The inclusion criteria were: post-hip surgery adults with and without a history of COVID-19 infection who attended their post-surgical follow-up consultation. The association of post-surgical complications in both groups was studied. The association of complications was analyzed with the chi-squared statistical test, and the effect size with Cramer’s V test.

RESULTS: The association of complications and a history of COVID-19 infection was moderate, with a chi-squared of 2.55, V Cramer of 0.23. The most frequent complication was aseptic loosening of prosthetic components. The pre-surgical diagnosis and its association with both groups had a chi-squared of 10.07, and a V Cramer of 0.45, at the expense of hip fracture.

CONCLUSIONS: A history of COVID-19 infection may be associated with the presence of post-surgical complications. Aseptic loosening of prosthetic components was the most frequent complication in both groups of patients, and hip fracture was the main pre-surgical diagnosis.

PMID:38016143

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Predicting recurrence and survival in patients with non-metastatic renal-cell carcinoma after nephrectomy: a prospective population-based study with multicenter validation

Int J Surg. 2023 Nov 27. doi: 10.1097/JS9.0000000000000935. Online ahead of print.

ABSTRACT

BACKGROUND: Accurate prognostication of oncological outcomes is crucial for the optimal management of patients with renal cell carcinoma (RCC) after surgery. Previous prediction models were developed mainly based on retrospective data in the Western populations and their predicting accuracy remain limited in the contemporary, prospective validation. We aimed to develop contemporary RCC prognostic models for recurrence and overall survival using prospective population-based patient cohort and compare their performance with existing mostly utilized ones.

METHODS: In this prospective analysis and external validation study, the development set included 11,128 consecutive patients with non-metastatic RCC treated at a tertiary urology center in China between 2006 and 2022, and the validation set included 853 patients treated at 13 medical centers in the USA between 1996 and 2013. The primary outcome was progression-free survival (PFS), and the secondary outcome was overall survival (OS). Multivariable Cox regression was used for variable selection and model development. Model performance was assessed by discrimination (Harrell’s C-index and time-dependent areas under the curve [AUC]) and calibration (calibration plots). Models were validated internally by bootstrapping and externally by examining their performance in the validation set. The predictive accuracy of the models was compared with validated models commonly used in clinical trial designs and with recently developed models without extensive validation.

RESULTS: Of the 11,128 patients included in the development set, 633 PFS and 588 OS events occurred over a median follow-up of 4.3 years (IQR 1.7-7.8). Six common clinicopathologic variables (tumor necrosis, size, grade, thrombus, nodal involvement, and perinephric or renal sinus fat invasion) were included in each model. The models demonstrated similar C-indices in the development set (0.790 [95% CI 0.773-0.806] for PFS and 0.793 [95% CI 0.773-0.811] for OS) and in the external validation set (0.773 [0.731-0.816] and 0.723 [0.731-0.816]). A relatively stable predictive ability of the models was observed in the development set (PFS: time-dependent AUC 0.832 at 1 y to 0.760 at 9 y; OS: 0.828 at 1 y to 0.794 at 9 y). The models were well calibrated and their predictions correlated with the observed outcome at 3-, 5-, and 7-year in both development and validation sets. In comparison to existing prognostic models, the present models showed superior performance, as indicated by C-indices ranging from 0.722 to 0.755 (all P<0.0001) for PFS and from 0.680 to 0.744 (all P<0.0001) for OS. The predictive accuracy of the current models was robust in patients with clear-cell and non-clear-cell RCC.

CONCLUSIONS: Based on a prospective population-based patient cohort, the newly developed prognostic models were externally validated and outperform the currently available models for predicting recurrence and survival in patients with non-metastatic RCC after surgery. The current models have the potential to aid in clinical trial design and facilitate clinical decision making for both clear cell and non-clear cell RCC patients at varying risk of recurrence and survival.

PMID:38016139 | DOI:10.1097/JS9.0000000000000935

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Is antibiotic prophylaxis generally safe and effective in surgical and non-surgical scenarios? Evidence from an umbrella review of randomized controlled trials

Int J Surg. 2023 Nov 28. doi: 10.1097/JS9.0000000000000923. Online ahead of print.

ABSTRACT

BACKGROUND: We aimed to comprehensively evaluate the efficacy and safety of antibiotic prophylaxis through surgical and non-surgical scenarios and assess the strength of evidence.

MATERIALS AND METHODS: We performed an umbrella review of meta-analyses of randomized controlled trials (RCTs). An evidence map was created to summarize the absolute benefits of antibiotic prophylaxis in each scenario and certainty of evidence.

RESULTS: 75 meta-analyses proved eligible with 725 RCTs and 78 clinical scenarios in surgical and medical prophylaxis. Of 119 health outcomes, 67 (56.3%) showed statistically significant benefits, 34 of which were supported by convincing or highly suggestive evidence from RCTs. For surgeries, antibiotic prophylaxis may minimize infection occurrences in most surgeries except Mohs surgery, simple hand surgery, herniorrhaphy surgery, hepatectomy, thyroid surgery, rhinoplasty, stented distal hypospadias repair, midurethral sling placement, endoscopic sinus surgery, and transurethral resection of bladder tumors with only low to very low certainty evidence. For non-surgery invasive procedures, only low to very low certainty evidence showed benefits of antibiotic prophylaxis for cystoscopy, postoperative urinary catheterization, and urodynamic study. For medical prophylaxis, antibiotic prophylaxis showed greater benefits in non-emergency scenarios, in which patients were mainly with weakened immune systems, or at risk of recurrent chronic infections. Antibiotics prophylaxis may increase antibiotic resistance or other adverse events in most scenarios and reached significance in cystoscopy, afebrile neutropenia following chemotherapy and hematopoietic stem cell transplantation.

CONCLUSIONS: Antibiotic prophylaxis in surgical and non-surgical scenarios is generally effective and seems independent of surgical cleanliness and urgency of diseases. Its safety is not well determined due to lack of available data. Nevertheless, the low quality of current evidence limits the external validity of these findings, necessitating clinicians to judiciously assess indications, balancing low infection rates with antibiotic-related side effects.

PMID:38016138 | DOI:10.1097/JS9.0000000000000923

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Correlation of equations for energy expenditure with indirect calorimetry in critically ill patients

Rev Med Inst Mex Seguro Soc. 2023 Sep 18;61(Suppl 2):S246-S253.

ABSTRACT

BACKGROUND: Nutrition in the Intensive Care Unit (ICU) is a cornerstone; however, energy requirements are a controversial issue that has not yet been resolved. Calorimetry is the gold standard for calculating energy expenditure, but it is expensive and not available in all ICU areas. Formulas have been developed to calculate basal energy expenditure (BAE) and make the process easier.

OBJECTIVE: To validate the predictive formulas of BAE compared to that obtained with ventilatory indirect calorimetry (IC) within the nutritional assessment in ICU patients.

MATERIAL AND METHODS: Analytical cross-sectional retrolective study. We performed BAE measurement on patients in the ICU of a third level hospital with ventilatory indirect calorimetry and compared the results obtained with those of the Harris Benedict, Muffin-St. Jeor, Institute of Medicine, and Faisy equations.

RESULTS: A total of 49 patients were included; a moderate correlation with statistical significance was found between the BAE measurements obtained by indirect calorimetry, with those obtained by four predictive equations that were studied. The Faisy equation obtained the strongest correction with r = 0.461 (p = 0.001).

CONCLUSION: The correlation between the BAE obtained by predictive equations and by IC goes from mild to moderate, due to the heterogeneity of critical patients and their changing nature throughout their disease.

PMID:38016112

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Efficacy evaluation of symptom-complex physiotherapy in polymorbidity based on randomized comparative studies

Vopr Kurortol Fizioter Lech Fiz Kult. 2023;100(5):14-20. doi: 10.17116/kurort202310005114.

ABSTRACT

The problem of comprehensive physical therapy in polymorbidity (PM) identifies among the most urgent difficulties of modern rehabilitation medicine. It is known that PM are more common than it is generally accepted, and their impact on the endpoints of rehabilitative treatment is more significant. Yet, many problems of PM have not been investigated and properly solved.

OBJECTIVE: To evaluate the efficacy of comprehensive physical therapy (CPT) in PM in the age aspect on the basis of correlation analysis and ANOVA indicators (OR, RR, Q, x2, r2), as well as evidence-based medicine (EBM), in particular randomized comparative study (RCS).

MATERIAL AND METHODS: A number of patients with PM equal 554 underwent CPT, of which 204 (36.8%) were male and 350 (63.2%) female. The identified age cohorts were following: the 1st group – 188 (33.9%) patients aged from 45 to 59; the 2nd group – 366 (66.1%) patients aged from 60 to 74. The ratio of middle-aged and elderly patients was 1.9:1.

RESULTS: The efficacy of CPT in patients with PM was judged, first of all, by documentary (medical histories and medical records of patients) and mathematical data (OR, RR, Q, x2, r2). The evidence level of CPT effect was determined on the basis of the analysis of the particular method’s study results.

CONCLUSION: The incidence of positive CPT result in middle-aged patients was higher than in elderly. The positive strong statistical correlation between comprehensive physical therapy and the endpoint in most classes of diseases of patients with PM. The comparative assessment of CPT efficacy based on the EBM principles revealed the advantages of their use for elderly patients relative to middle-aged group.

PMID:38016052 | DOI:10.17116/kurort202310005114