Nevin Manimala

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

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

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

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

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

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

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

Trans R Soc Trop Med Hyg. 2023 Nov 28:trad083. doi: 10.1093/trstmh/trad083. Online ahead of print.

ABSTRACT

BACKGROUND: Nigeria instituted the National Health Insurance Scheme (NHIS) for universal health coverage. This study compared the NHIS and out-of-pocket (OOP) antibiotic prescribing with the World Health Organization (WHO) optimal values.

METHODS: A total of 2190 prescription forms from the NHIS and OOP were included in this study conducted at Obafemi Awolowo University Teaching Hospitals Complex, Nigeria from January 2021 to December 2022 and analysed using WHO drug prescribing guidelines.

RESULTS: The average number of drugs per encounter was higher in the NHIS prescribing (χ2=58.956, p=0.00) than in OOP prescribing. The percentage of encounters with an antibiotic prescribed is higher in NHIS prescribing (χ2=46.034, p=0.000) than in OOP prescribing. The percentage of parenteral antibiotic prescribing is higher in OOP prescribing (χ2=25.413, p=0.000) than in NHIS prescribing. The percentage of antibiotic prescribed from the National Essential Medicine List is higher in NHIS prescribing (χ2=8.227, p=0.000) as well as the antibiotics prescribed from the Access category of the WHO Access, Watch and Reserve (AWaRe) Classification of antibiotics (χ2=23.946, p=0.000) when compared with OOP prescribing.

CONCLUSIONS: Prescribing indicators show better performances with NHIS antibiotic prescribing and are closer to the WHO-recommended optimal values than in OPP prescribing. Hence NHIS prescribing can be an easy target for hospital antibiotic stewardship intervention for optimal antibiotic prescribing.

PMID:38016023 | DOI:10.1093/trstmh/trad083

Cornea. 2023 Nov 28. doi: 10.1097/ICO.0000000000003438. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this study was to report a case series of central toxic keratopathy (CTK) after collagen cross-linking (CXL) in keratoconus.

METHODS: This is a retrospective case series between January 2020 and September 2021. In this period, CXL was performed for progressive keratoconus in 964 eyes. CXL was performed using the epithelium-off accelerated protocol in all patients with a riboflavin soak time of 20 minutes and a UVA light exposure of 9 mW for 10 minutes using the Avedro KXL (Glaukos Inc, Aliso Viejo, CA) cross-linking system.

RESULTS: Twelve of 964 eyes (1.2%) developed CTK within 1 week of CXL. All patients presented with well-circumscribed, central disciform haze that was broader in the anterior stroma and narrower in the posterior stroma. We noted initial flattening in keratometry up to 3 months post-CXL in these patients, which gradually steepened over 12 months, but did not reach preoperative levels. We also noted exuberant flattening in pachymetry in the first 3 months, which improved over 12 months. There was a statistically significant decrease in pachymetry in patients who developed CTK at 3 and 12 months postoperatively when compared to patients who underwent CXL but did not develop CTK.

CONCLUSIONS: Several reports of CTK postrefractive surgery have been described previously. However, the association of CXL in the development of CTK has not been described previously. Here, we elucidated the clinical features of CTK after CXL and how it differs from corneal scarring or haze that occurs post-CXL.

PMID:38016022 | DOI:10.1097/ICO.0000000000003438

PLoS One. 2023 Nov 28;18(11):e0294947. doi: 10.1371/journal.pone.0294947. eCollection 2023.

ABSTRACT

This article is based on the statistical yearbook data of 30 provinces, municipalities and autonomous regions in China (excluding Hong Kong, Macao, Taiwan, and Tibet Autonomous Region) from 2000 to 2017, a total of 18 years of statistical yearbook data was used to conduct in-depth research on the reduction of CO2 emissions from the development of new energy in the region. First, it is proposed that the regional new energy development has a significant negative effect on CO2 emissions. Meanwhile, this impact has a significant time lag effect, and the development of new energy cannot be quickly and effectively applied in the short term to replace traditional fossil energy in the dynamic model. Therefore, there is a significant positive impact in the short term, but the significant negative effect of new energy development on CO2 emission can be shown in the long run. Secondly, the new energy development has a significant non-linear impact on CO2 emissions, showing an inverted U-shaped relationship, which confirms the existence of the Environmental Kuznets Curve (EKC) of CO2 emissions based on new energy development. Finally, in order to alleviate the continuous impact of national economic development on CO2 emissions, the DID model is used to prove that the level of technological innovation has a significant moderating effect on the CO2 emission reduction effect of new energy development, which confirms theoretically the importance of technological innovation in accelerating new energy substitution and improving energy efficiency.

PMID:38016002 | DOI:10.1371/journal.pone.0294947