Category: Nevin Manimala

Neurourol Urodyn. 2022 Dec 1. doi: 10.1002/nau.25107. Online ahead of print.

ABSTRACT

BACKGROUND: Intradetrusor onabotulinumtoxinA injection is an effective advanced treatment for overactive bladder. While the effective dosages have been well studied, very little data exist on treatment efficacy using differing injection techniques. The objective of this study was to determine whether the efficacy of a reduced injection technique of 5 injection sites was noninferior to the standard technique of 20 injection sites of intradetrusor onabotulinumtoxinA for treatment of overactive bladder.

METHODS: In this randomized noninferiority trial, men and women seeking treatment of overactive bladder with intradetrusor onabotulinumtoxinA injections were randomized to receive 100 units administered via either a reduced injection technique of 5 injection sites or a standard injection technique of 20 injection sites. Subjects completed a series of standardized questionnaires at baseline and at 4-12 weeks postprocedure to determine symptom severity and treatment efficacy. The primary outcome was treatment efficacy as determined by Overactive Bladder Questionnaire-Short Form with a noninferiority margin of 15 points. Secondary outcomes were incidence of urinary tract infection and urinary retention requiring catheterization.

RESULTS: Data from 77 subjects were available for analysis with 39 in the control arm (20 injections) and 38 in the study arm (5 injections). There was a significant improvement in both arms from baseline to follow-up in Overactive Bladder Questionnaire-Short Form and International Consultation on Incontinence Questionnaire scores (p < 0.001). Overall treatment success was 68% with no statistically significant difference between arms. A significant difference between arms was found on the Overactive Bladder Questionnaire-Short Form quality of life survey favoring the control arm (confidence interval [CI]: 0.36-20.5, p = 0.04). However, there were no significant differences between arms in the remaining validated questionnaires. The study arm did not demonstrate noninferiority to the control arm. Subjects in the study arm were significantly more likely to express a willingness to undergo the procedure again (odds ratio = 3.8, 95% CI: 1.42-10.67, p = 0.004). Adverse events did not differ between arms.

CONCLUSIONS: A reduced injection technique for administration of intradetrusor onabotulinumtoxinA demonstrates similar efficacy to the standard injection technique but did not demonstrate noninferiority. Subjects preferred the reduced injection technique over the standard technique. A reduced injection technique is a safe and effective alternative to the standard technique.

PMID:36455284 | DOI:10.1002/nau.25107

Neurosurg Focus. 2022 Dec;53(6):E9. doi: 10.3171/2022.9.FOCUS22402.

ABSTRACT

OBJECTIVE: Perioperative and/or postoperative cerebrovascular accidents (PCVAs) after intracranial tumor resection (ITR) are serious complications with devastating effects on quality of life and survival. Here, the authors retrospectively analyzed a prospectively maintained, multicenter surgical registry to design a risk model for PCVA after ITR to support efforts in neurosurgical personalized medicine to risk stratify patients and potentially mitigate poor outcomes.

METHODS: The National Surgical Quality Improvement Program database was queried for ITR cases (2015-2019, n = 30,951). Patients with and without PCVAs were compared on baseline demographics, preoperative clinical characteristics, and outcomes. Frailty (physiological reserve for surgery) was measured by the Revised Risk Analysis Index (RAI-rev). Logistic regression analysis was performed to identify independent associations between preoperative covariates and PCVA occurrence. The ITR-PCVA risk model was generated based on logit effect sizes and assessed in area under the receiver operating characteristic curve (AUROC) analysis.

RESULTS: The rate of PCVA was 1.7% (n = 532). Patients with PCVAs, on average, were older and frailer, and had increased rates of nonelective surgery, interhospital transfer status, diabetes, hypertension, unintentional weight loss, and elevated BUN. PCVA was associated with higher rates of postoperative reintubation, infection, thromboembolic events, prolonged length of stay, readmission, reoperation, nonhome discharge destination, and 30-day mortality (all p < 0.001). In multivariable analysis, predictors of PCVAs included RAI “frail” category (OR 1.7, 95% CI 1.2-2.4; p = 0.006), Black (vs White) race (OR 1.5, 95% CI 1.1-2.1; p = 0.009), nonelective surgery (OR 1.4, 95% CI 1.1-1.7; p = 0.003), diabetes mellitus (OR 1.5, 95% CI 1.1-1.9; p = 0.002), hypertension (OR 1.4, 95% CI 1.1-1.7; p = 0.006), and preoperative elevated blood urea nitrogen (OR 1.4, 95% CI 1.1-1.8; p = 0.014). The ITR-PCVA predictive model was proposed from the resultant multivariable analysis and performed with a modest C-statistic in AUROC analysis of 0.64 (95% CI 0.61-0.66). Multicollinearity diagnostics did not detect any correlation between RAI-rev parameters and other covariates (variance inflation factor = 1).

CONCLUSIONS: The current study proposes a novel preoperative risk model for PCVA in patients undergoing ITR. Patients with poor physiological reserve (measured by frailty), multiple comorbidities, abnormal preoperative laboratory values, and those admitted under high acuity were at highest risk. The ITR-PCVA risk model may support patient-centered counseling striving to respect goals of care and maximize quality of life. Future prospective studies are warranted to validate the ITR-PCVA risk model and evaluate its utility as a bedside clinical tool.

PMID:36455279 | DOI:10.3171/2022.9.FOCUS22402

Neurosurg Focus. 2022 Dec;53(6):E12. doi: 10.3171/2022.9.FOCUS22429.

ABSTRACT

OBJECTIVE: Intraoperative neuropathological assessment with conventional frozen sections supports the neurosurgeon in optimizing the surgical strategy. However, preparation and review of frozen sections can take as long as 45 minutes. Stimulated Raman histology (SRH) was introduced as a novel technique to provide rapid high-resolution digital images of unprocessed tissue samples directly in the operating room that are comparable to conventional histopathological images. Additionally, SRH images are simultaneously and easily accessible for neuropathological judgment. Recently, the first study showed promising results regarding the accuracy and feasibility of SRH compared with conventional histopathology. Thus, the aim of this study was to compare SRH with conventional H&E images and frozen sections in a large cohort of patients with different suspected central nervous system (CNS) tumors.

METHODS: The authors included patients who underwent resection or stereotactic biopsy of suspected CNS neoplasm, including brain and spinal tumors. Intraoperatively, tissue samples were safely collected and SRH analysis was performed directly in the operating room. To enable optimal comparison of SRH with H&E images and frozen sections, the authors created a digital databank that included images obtained with all 3 imaging modalities. Subsequently, 2 neuropathologists investigated the diagnostic accuracy, tumor cellularity, and presence of diagnostic histopathological characteristics (score 0 [not present] through 3 [excellent]) determined with SRH images and compared these data to those of H&E images and frozen sections, if available.

RESULTS: In total, 94 patients with various suspected CNS tumors were included, and the application of SRH directly in the operating room was feasible in all cases. The diagnostic accuracy based on SRH images was 99% when compared with the final histopathological diagnosis based on H&E images. Additionally, the same histopathological diagnosis was established in all SRH images (100%) when compared with that of the corresponding frozen sections. Moreover, the authors found a statistically significant correlation in tumor cellularity between SRH images and corresponding H&E images (p < 0.0005 and R = 0.867, Pearson correlation coefficient). Finally, excellent (score 3) or good (2) accordance between diagnostic histopathological characteristics and H&E images was present in 95% of cases.

CONCLUSIONS: The results of this retrospective analysis demonstrate the near-perfect diagnostic accuracy and capability of visualizing relevant histopathological characteristics with SRH compared with conventional H&E staining and frozen sections. Therefore, digital SRH histopathology seems especially useful for rapid intraoperative investigation to confirm the presence of diagnostic tumor tissue and the precise tumor entity, as well as to rapidly analyze multiple tissue biopsies from the suspected tumor margin. A real-time analysis comparing SRH images and conventional histological images at the time of surgery should be performed as the next step in future studies.

PMID:36455278 | DOI:10.3171/2022.9.FOCUS22429

Epidemiology. 2023 Jan 1;34(1):38-44. doi: 10.1097/EDE.0000000000001545. Epub 2022 Sep 27.

ABSTRACT

BACKGROUND: In many research settings, the intervention implied by the average causal effect of a time-varying exposure is impractical or unrealistic, and we might instead prefer a more realistic target estimand. Instead of requiring all individuals to be always exposed versus unexposed, incremental effects quantify the impact of merely shifting each individual’s probability of being exposed.

METHODS: We demonstrate the estimation of incremental effects in the time-varying setting, using data from the Effects of Aspirin in Gestation and Reproduction trial, which assessed the effect of preconception low-dose aspirin on pregnancy outcomes. Compliance to aspirin or placebo was summarized weekly and was affected by time-varying confounders such as bleeding or nausea. We sought to estimate what the incidence of pregnancy by 26 weeks postrandomization would have been if we shifted each participant’s probability of taking aspirin or placebo each week by odds ratios (OR) between 0.30 and 3.00.

RESULTS: Under no intervention (OR = 1), the incidence of pregnancy was 77% (95% CI: 74%, 80%). Decreasing women’s probability of complying with aspirin had little estimated effect on pregnancy incidence. When we increased women’s probability of taking aspirin, estimated incidence of pregnancy increased, from 83% (95% confidence interval [CI] = 79%, 87%) for OR = 2 to 89% (95% CI = 84%, 93%) for OR=3. We observed similar results when we shifted women’s probability of complying with a placebo.

CONCLUSIONS: These results estimated that realistic interventions to increase women’s probability of taking aspirin would have yielded little to no impact on the incidence of pregnancy, relative to similar interventions on placebo.

PMID:36455245 | DOI:10.1097/EDE.0000000000001545

Epidemiology. 2023 Jan 1;34(1):8-19. doi: 10.1097/EDE.0000000000001555. Epub 2022 Sep 27.

ABSTRACT

In longitudinal studies with time-varying exposures and mediators, the mediational g-formula is an important method for the assessment of direct and indirect effects. However, current methodologies based on the mediational g-formula can deal with only one mediator. This limitation makes these methodologies inapplicable to many scenarios. Hence, we develop a novel methodology by extending the mediational g-formula to cover cases with multiple time-varying mediators. We formulate two variants of our approach that are each suited to a distinct set of assumptions and effect definitions and present nonparametric identification results of each variant. We further show how complex causal mechanisms (whose complexity derives from the presence of multiple time-varying mediators) can be untangled. We implemented a parametric method, along with a user-friendly algorithm, in R software. We illustrate our method by investigating the complex causal mechanism underlying the progression of chronic obstructive pulmonary disease. We found that the effects of lung function impairment mediated by dyspnea symptoms accounted for 14.6% of the total effect and that mediated by physical activity accounted for 11.9%. Our analyses thus illustrate the power of this approach, providing evidence for the mediating role of dyspnea and physical activity on the causal pathway from lung function impairment to health status. See video abstract at, http://links.lww.com/EDE/B988.

PMID:36455244 | DOI:10.1097/EDE.0000000000001555

PLoS One. 2022 Dec 1;17(12):e0278224. doi: 10.1371/journal.pone.0278224. eCollection 2022.

ABSTRACT

INTRODUCTION: Malaria is the second leading cause of death in children after diarrheal disease, with low- and middle-income countries (LMICs) accounting for over 9 in 10 incidence and deaths. Widespread acceptance and uptake of the RTS,S vaccine, recently approved by the world health organization (WHO), is projected to significantly reduce malaria incidence and deaths. Therefore, we conducted this systematic review and meta-analysis with the aim to determine the malaria vaccine acceptance rate and the factors associated with acceptance.

METHODS: We searched six databases including Google Scholar, PubMed, Cochrane, African Index Medicus, The Regional Office for Africa Library, and WHO Institutional Repository for Information Sharing (IRIS) to identify studies evaluating the malaria vaccine acceptance rate. This systematic review and meta-analysis followed the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines. Studies were included if they were original articles published in the English language in peer-reviewed journals and assessed the prevalence of willingness to accept a free malaria vaccine, and not qualitative. The risk of publication bias was checked using both Beggar’s funnel plot and Egger’s test, while the I2 statistic was used to assess the heterogeneity of the included studies. Study quality was determined using the Newcastle-Ottawa scale. A meta-analysis was performed using a random effects model to evaluate the pooled prevalence of malaria vaccine acceptance. The protocol for this article was registered prospectively on the International Prospective Register for Systematic Reviews (PROSPERO), with ID number CRD42022334282).

RESULTS: Our analysis included 11 studies with a total sample size of 14, 666 participants. The aggregate malaria vaccine acceptance rate was 95.3% (95% CI:93.0%-97.2%). Among the general population, the acceptance rate was 96.3% (95% CI:92.0%-99.0%) and among mothers, it was 94.4% (95% CI:90.8%-97.2%). By country, Nigeria had the highest acceptance rate (97.6%, 95% CI:96.0%-98.8%), followed by Ghana (94.6%, 95% CI:93.8%-95.3%) and Tanzania (92.5%, 95% CI:84.4%-97.8%). Sociodemographic determinants of vaccine acceptance included place of residence, tribe, age, sex, occupation, and religion. Reasons for low acceptance included safety concerns, efficacy profile, vaccine’s requirement for multiple injections, and poor level of awareness.

CONCLUSION: Future efforts should be focused on identifying factors that may improve the actual uptake of the RTS,S vaccine in malaria-endemic communities.

PMID:36455209 | DOI:10.1371/journal.pone.0278224

JCO Clin Cancer Inform. 2022 Nov;6:e2200093. doi: 10.1200/CCI.22.00093.

ABSTRACT

PURPOSE: The aim of the present work was to investigate the role of apoptosis inhibitor BIRC6 (baculoviral IAP repeat-containing protein 6) in breast cancer (BC), focusing particularly on its involvement in the metastatic cascade.

METHODS: We analyzed BIRC6 mRNA expression levels and copy number variations in three BC databases from The Cancer Genome Atlas comparing clinical and molecular attributes. Genomic analysis was performed using the cBioPortal platform, whereas transcriptomic studies (mRNA expression levels, correlation heatmaps, survival plots, and gene ontology) were performed using USC Xena and R. Statistical significance was set at P < .05.

RESULTS: Our bioinformatic analyses showed that there was a differential expression of BIRC6 in cancer samples when compared with normal samples. Copy number variations that involve amplification and gain of BIRC6 gene were correlated with negative hormone receptor tumors, higher prognostic indexes, younger age at diagnosis, and both chemotherapy and radiotherapy administration. Transcriptomic and gene ontology analyses showed that, under conditions of high BIRC6 mRNA levels, there are differential expression patterns in apoptotic, proliferation, and metastatic pathways.

CONCLUSION: In summary, our in silico data suggest that BIRC6 plays an antiapoptotic, pro-proliferative, and apparent prometastatic role and could be a relevant molecular target for treatment of BC tumors.

PMID:36455174 | DOI:10.1200/CCI.22.00093

Altern Ther Health Med. 2022 Dec 2:AT7274. Online ahead of print.

ABSTRACT

CONTEXT: Cardiovascular diseases (CVDs caused by atherosclerosis, such as coronary heart disease and stroke, have become major causes of death and disability worldwide. Atherosclerosis is the primary pathological factor causing CVDs. Managing weight, blood pressure, and lipids is one of the tenets of chronic-disease management, including atherosclerosis.

OBJECTIVE: The study intended to investigate the effects of managing weight, blood pressure, and lipids on disease severity in patients with carotid atherosclerosis.

DESIGN: The research team designed a randomized, controlled trial.

SETTING: The study took place in the pediatric department at the First Hospital of Hebei Medical University in Shijiazhuang, Hebei Province, China.

PARTICIPANTS: Participants were 380 patients with carotid atherosclerosis who entered the hospital between March 2018 and June 2020.

INTERVENTION: Participants were randomly assigned, using the random-number-table method, to an intervention or a control group, with 190 participants in each group. Both groups received anti-atherosclerotic treatments, and the intervention group also took part in a program for combined management of weight, blood pressure, and blood lipids.

OUTCOME MEASURES: All measurements occurred at baseline and postintervention. Using a questionnaire, the study measured the changes in the two groups related to alcohol consumption, smoking, high-fat diet, high-salt diet, and lack of exercise. A physical examination provided participants’ weights, blood pressures, and lipid levels, and the Self-Care Ability Assessment Scale (ESCA) provided the changes in their self-management ability. A carotid-artery examination measured parameters related to carotid atherosclerosis, including intima-media thickness (IMT), Crouse scores, plaque-class scores, and plaque-grade scores.

RESULTS: At baseline, no statistically significant differences existed between the groups. Postintervention, the intervention group had significantly greater decreases than the control group for alcohol consumption, smoking, high-fat diet, high-salt diet, lack of exercise, weight, blood pressure, lipid levels, intima-media thickness (IMT) scores, Crouse scores, and plaque-grade scores. Postintervention, the intervention group had significantly greater increases than the control group for self-responsibility, health knowledge, self-concept, and self-care-skills scores.

CONCLUSIONS: A program for management of body weight, blood pressure, and blood lipids can effectively control the severity of carotid atherosclerosis, can prevent the disease’s progression, and can be promoted as a clinical application.

PMID:36455146

Altern Ther Health Med. 2022 Dec 2:AT7645. Online ahead of print.

ABSTRACT

CONTEXT: Patients receiving in vitro fertilization and embryo transfer (IVF-ET) treatments can be anxious and depressed and have other negative emotions. Psychological interventions might improve the clinical pregnancy rate of infertile patients. Heart rate variability (HRV) biofeedback can be an effective technique to treat anxiety and stress symptoms.

OBJECTIVE: The study intended to investigate the effects and clinical outcomes of HRV biofeedback for women undergoing in vitro fertilization-embryo transfer (IVF-ET) for the first time.

DESIGN: The research team performed a prospective randomized controlled study.

SETTING: The study took place at the Reproduction Center of the First Affiliated Hospital of Hebei Medical University in Shijiazhuang, Hebei, China.

PARTICIPANTS: Participants were 60 women who received IVF-ET for the first time at the hospital between January 2015 and December 2017.

INTERVENTION: Participants were randomly divided into the intervention group (n = 30), who received HRV biofeedback, and the control group, who received routine education (n = 30).

OUTCOME MEASURES: At baseline and postintervention, the research team analyzed outcomes using: (1) the scores from a self-rating anxiety scale (SAS) and a self-rating depression scale (SDS); (2) HRV indexes, including the standard deviation of normal to normal (SDNN), root mean square of successive differences (RMSSD), percentage of successive R-R intervals that differ by more than 50 milliseconds (PNN50), total power (TP), low frequency (LF), high frequency (HF), and rate of LF and HF (LF/HF); and (3) pregnancy rates.

RESULTS: The control group’s SAS scores were significantly higher postintervention, at 48.63 ± 4.75, than those of the intervention group, at 39.23 ± 7.60 (P = .000). The control group’s SDS scores, at 53.07 ± 3.89, were also significantly higher postintervention than those of the intervention group, at 41.40 ± 9.60 (P = .000). For the intervention group, between baseline and postintervention four of the HRV indexes significantly increased: (1) SDNN-from 53.67 ± 9.03 to 79.57 ± 20.48 (p=0.000), (2) RMSSD-from 54.97 ± 13.94 to. 83.74 ± 34.40 (P = .000), (5) PNN50-15.04 ± 6.06 to 22.92 ± 9.90 (P = .001) and (4) TP-from 851.32 ± 486.47 to 1579.59 ± 746.86 (P = .000). The clinical pregnancy rate in the intervention group was higher than that in the control group but the difference wasn’t statistically significant, at 60.00% and 46.67%, respectively (P = .438).

CONCLUSIONS: HRV biofeedback treatment significantly increased four HRV indexes and decreased the anxiety and depression of women undergoing IVF-ET for the first time, showing a potential clinical application.

PMID:36455143

Am J Audiol. 2022 Dec 1:1-9. doi: 10.1044/2022_AJA-22-00055. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of this study was to evaluate the stress, quality of life, and access to hearing health services experienced by adults and children who use hearing aid and/or cochlear implant and their families during the COVID-19 pandemic.

METHOD: Perceived Stress Scale, Personal Wellbeing Index, and World Health Organization Quality of Life questionnaires were applied online to 30 adults with hearing loss and parents of 61 children with hearing loss. Also, a survey was conducted to acquire more about the demographics of people who use cochlear implants and conventional hearing aids, as well as the difficulties they encountered during the COVID-19 period.

RESULTS: Although child user families experienced more problems than adults during the COVID-19 period, the stress levels of child user families were higher than that of adult user families (p = .05). Even though there was no statistically significant difference, the families of pediatric users had lower quality of life than adult users.

CONCLUSIONS: The stress/anxiety problems that arise as a result of this are coming to the forefront of both patients and their relatives. The findings indicate that creative strategies should be developed to give individuals with hearing loss efficient access to hearing health services.

PMID:36455137 | DOI:10.1044/2022_AJA-22-00055