Category: Statistics

Egypt Heart J. 2023 Oct 13;75(1):87. doi: 10.1186/s43044-023-00414-w.

ABSTRACT

BACKGROUND: Dynamic functional substrate mapping of scar-related ventricular tachycardia offers better identification of ablation targets with limited ablation lesions. Several functional substrate mapping approaches have been proposed, including decrement-evoked potential (DEEP) mapping. The aim of our study was to compare the short- and long-term efficacy of a DEEP-guided versus a fixed-substrate-guided strategy for the ablation of scar-related ventricular tachycardia (VT).

RESULTS: Forty consecutive patients presenting for ablation of scar-related VT were randomized to either DEEP-guided or substrate-guided ablation. Late potentials were tagged and ablated in the non-DEEP group, while those in the DEEP group were subjected to RV extrastimulation after a drive train. Only potentials showing significant delay were ablated. Patients were followed for a median duration of 12 months. Twenty patients were allocated to the DEEP group, while the other 20 were allocated to the non-DEEP group. Twelve patients (60%) in the DEEP group had ischemic cardiomyopathy versus 10 patients (50%) in the non-DEEP group (P-value 0.525). Intraoperatively, the median percentage of points with LPs was 19% in the DEEP group and 20.6% in the non-DEEP group. The procedural time was longer in the DEEP group, approaching but missing statistical significance (P-value 0.059). VT non-inducibility was successfully accomplished in 16 patients (80%) in the DEEP group versus 17 patients (85%) in the non-DEEP group (P value 0.597). After a median follow-up duration of 12 months, the VT recurrence rate was 65% in both groups (P value 0.311), with a dropout rate of 10% in the DEEP group. As for the secondary endpoints, all-cause mortality rates were 20% and 25% in the DEEP and non-DEEP groups, respectively (P-value 0.342).

CONCLUSIONS: DEEP-assisted ablation of scar-related ventricular tachycardia is a feasible strategy with comparable short- and long-term outcomes to a fixed-substrate-based strategy with more specific ablation targets, albeit relatively longer but non-significant procedural times and higher procedural deaths. The imbalance between the study groups in terms of epicardial versus endocardial mapping, although non-significant, warrants the prudent interpretation of our results. Further large-scale randomized trials are recommended.

TRIAL REGISTRATION: clinicaltrials.gov, registration number: NCT05086510, registered on 28th September 2021, record https://classic.

CLINICALTRIALS: gov/ct2/show/NCT05086510.

PMID:37831212 | DOI:10.1186/s43044-023-00414-w

Lasers Med Sci. 2023 Oct 13;38(1):233. doi: 10.1007/s10103-023-03900-4.

ABSTRACT

Myofascial pain dysfunction syndrome (MPDS) is one of the most common sources of orofacial pain. There are different types of physical therapy for patients with MPDS, but there is insufficient evidence that any one treatment method is superior. This study aimed to compare the clinical efficacy of transcutaneous electrical nerve stimulation (TENS) and laser acupuncture (LA) using a 940-nm diode on MPDS improvement. In this randomized clinical trial, 22 MPDS patients were randomly assigned to TENS (180 HZ, 300 µs, 20 min) and LA (940 nm, continuous wave, 0. 5 w, 40 s, 105 J/cm2) groups. Data on overall facial pain, tenderness in the masticatory muscles, deviation, joint sound, and maximum mouth opening without pain (MMO) were collected from all patients at baseline, before and after each treatment session, and 1 month after the end session. Data were analyzed using an independent t-test, repeated measures ANOVA, and Fisher’s exact test at a significance level of P < 0.05. The decreases in overall facial pain (P = 0.000), muscle tenderness (P = 0.000), and increase in MMO (P = 0.01, P = 0.001) were statistically significant compared to the baseline in the TENS and AL groups. No significant differences were detected between TENS and LA for overall facial pain, muscle tenderness, or MMO at 1 month follow-up (P > 0.05). Both LA and TENS are effective physical therapies with promising effects on sign and symptom improvements in MPDS patients.

PMID:37831208 | DOI:10.1007/s10103-023-03900-4

J Burn Care Res. 2023 Oct 13:irad156. doi: 10.1093/jbcr/irad156. Online ahead of print.

ABSTRACT

Indocyanine green angiography (ICGA) has been widely employed for quantitative evaluation of the rat comb burn model, but the imaging equipment, imaging protocol, and fluorescence data interpretation of ICGA remain unsatisfactory. The aim of this study is to provide better solutions for the application of ICGA on perfusion analysis. The rat comb burn model was established under a series of different comb contact durations including 10, 20, 25, 30, 35, and 40 s. ICGA was used to analyze wound perfusion. Sixteen rats were divided into ibuprofen and control groups for the burn model, and their perfusion was compared. Sixteen identical models were divided into standard and high-dose ICG groups, and ICGA was conducted to investigate the dynamic change in wound fluorescence. Escharectomy was performed under real-time fluorescence mapping and navigation. The results showed that a comb contact duration of 30 s was optimum for the burn model. ICGA could accurately evaluate the histologically determined depth of thermal injury and wound perfusion in the rat comb model. Digital subtraction of residual fluorescence was necessary for multiple comparisons of perfusion. Dynamic changes in fluorescence and necrotic tissues were observed more clearly by high-dose (0.5 mg/kg) ICG in angiography. In conclusion, perfusion analysis by ICGA can be used to assess the histologically determined depth of thermal injury and the impact of a specific treatment on wound perfusion. ICGA can help to identify necrotic tissue. Above findings and related imaging protocols lay the foundation for future research.

PMID:37830308 | DOI:10.1093/jbcr/irad156

Exp Aging Res. 2023 Oct 13:1-11. doi: 10.1080/0361073X.2023.2269803. Online ahead of print.

ABSTRACT

OBJECTIVE: The purpose of this study was to assess the association between serum 25-hydroxyvitamin D [25(OH)D] levels and depressive symptoms in Mexican older adults 70 years and older.

METHODS: A total of 326 adults aged 70 or older from Coyoacán Cohort Study were included in this study. The depressive symptoms were assessing by Center for Epidemiologic Studies Depression Scale (CES-D) and serum 25-hydroxyvitamin D [25(OH)D] levels were measured by commercially available enzyme-linked immunosorbent assay (ELISA).

RESULTS: Overall, the prevalence of depressive symptoms was 36.5%. The mean age was 79 years, and 53.4% were women. The total serum 25-hydroxyvitamin D [25(OH)D] levels were lower in older adults with depressive symptoms when compared with older adults without depressive symptoms (p = .006). Logistic regression models showed a significant association between low serum 25(OH)D levels and depressive symptoms even after adjusting for potential confounders (OR = 2.453; 95% CI:1.218-4.939; p = .012). In addition, linear regression model to predict the effect of 25-hydroxyvitamin D [25(OH)D] levels on the CES-D score as a continuous variable, was statistically significant [F_(1,324) = 8.54, p = .004], and the R-squared value was .026, indicating that this regression model explains 2.6% of the change in the CES-D score.

CONCLUSION: These results suggest that older Mexican adults with lower serum 25-hydroxyvitamin D [25(OH)D] levels are at higher risk of presenting depressive symptoms.

PMID:37830306 | DOI:10.1080/0361073X.2023.2269803

Hum Reprod. 2023 Oct 12:dead208. doi: 10.1093/humrep/dead208. Online ahead of print.

ABSTRACT

STUDY QUESTION: Do women with multi-partner fertility or multi-partner behavior conceive more often than women with a single partner?

SUMMARY ANSWER: Women with multi-partner behavior conceived more frequently and had more children than non-multi-partner women and multi-partner fertility women.

WHAT IS KNOWN ALREADY: Some women experience having biological children with more than one partner: those women are considered as multi-partner fertility. Women with multi-partner fertility have more children and are substantially less likely to have planned their first birth. Individuals with multi-partner fertility become parents at a younger age, largely with unintended first births, and often do so outside of marriage, compared to parents with two or more children from only one partner. Unmarried women, particularly, are at greater risk of having unintended births. Studies are still scarce and there is a need to assess the contribution of women’s multi-partners fertility and multi-partner behavior to family composition, particularly in low- and middle-income countries.

STUDY DESIGN, SIZE, DURATION: This longitudinal birth cohort study evaluated 1215 mothers whose children belonging to the 2004 Pelotas Birth Cohort were their first pregnancy, and who attended the perinatal, 48-month, 6-year, and 11-year follow-ups. Information was obtained from responses to a questionnaire. The number of years at risk of having children was treated as the exposure, and woman’s multi-partner behavior and multi-partner fertility, dichotomized as ‘Yes’ or ‘No’, were considered endogenous treatment variables.

PARTICIPANTS/MATERIALS, SETTING, METHODS: Data from mothers with a first pregnancy, and with information available from the perinatal, 48-month, 6-year, and 11-year follow-ups, were evaluated. The exposures studied were women’s multi-partner behavior and multi-partner fertility (i.e. conceiving/giving birth), and the outcomes evaluated were the number of pregnancies, the number of children currently alive, and experience of unintended pregnancies from the birth of the child belonging to the 2004 birth cohort until 11 years later. Crude and adjusted risk ratios (RRs) were estimated through Poisson regression with endogenous treatment effects, robust standard errors, and their respective 95% CI.

MAIN RESULTS AND THE ROLE OF CHANCE: Multi-partner behavior women had 16% (RR 1.16; 95% CI: 1.08-1.25) and 11% (RR 1.11; 95% CI 1.03-1.19) greater risk of having a new pregnancy and having more children alive, respectively, than those with non-multi-partner behavior. Women with multi-partner fertility had a 23% (RR 1.23; 95% CI: 1.11-1.37) and 20% (RR 1.20; 95% CI: 1.08-1.33) higher risk of having a new pregnancy and having more children alive, respectively, than single-partner fertility mothers. Women who had multiple partners (i.e. behavior), as well as those with multi-partner fertility, showed a lesser proportion of unintended pregnancies when compared to the non-multi-partner ones (34.08%; 95% CI: 28.12-40.60 vs 36.17%; 95% CI: 31.93-40.63), compared to their counterparts’ single partners fertility (33.16%; 95% CI: 26.83-40.17 vs 36.26%; 95% CI: 31.85-40.92), although these findings were not statistically significant.

LIMITATIONS, REASONS FOR CAUTION: The mothers who were not included in the study owing to missing data for some of the follow-up had 5-11 years of education, a low socio-economic level, and were younger, thus the number of pregnancies may be underestimated because these groups presented a high number of pregnancies and children alive. We did not have information about the complete woman’s conjugal history. Therefore, misclassification error of the exposure may be present and, consequently, the measures of association may be underestimated. Furthermore, this study was not truly representative of the Pelotas study female population.

WIDER IMPLICATIONS OF THE FINDINGS: In this study of multi-partner behavior and fertility, women who have multiple partners may be less likely to get married and have a stable partner. Compared to single-partner women, multi-partner fertility and multi-partner behavior women may predominantly become pregnant for the purpose of having children, rather than accidentally.

STUDY FUNDING/COMPETING INTEREST(S): This article is based on data from the study ‘Pelotas Birth Cohort, 2004’ conducted by the Postgraduate Program in Epidemiology at the Universidade Federal de Pelotas, with the collaboration of the Brazilian Public Health Association (ABRASCO). From 2009 to 2013, the Wellcome Trust supported the 2004 birth cohort study. The World Health Organization, National Support Program for Centers of Excellence (PRONEX), Brazilian National Research Council (CNPq), Brazilian Ministry of Health, and Children’s Pastorate supported previous phases of the study, and also was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-Brasil (CAPES)-Finance Code 001. The authors declare that the supported agencies have no role in any step of performing this study. No conflicts of interest exist.

TRIAL REGISTRATION NUMBER: N/A.

PMID:37830301 | DOI:10.1093/humrep/dead208

Neurourol Urodyn. 2023 Oct 13. doi: 10.1002/nau.25286. Online ahead of print.

ABSTRACT

OBJECTIVE: Success following urological procedures is traditionally defined through objective endpoints. This approach may not capture the impact on patient satisfaction. There is a paucity of literature evaluating patient-centered metrics such as satisfaction and decisional regret in the field of urology. This study investigates long-term satisfaction and decisional regret amongst patients who underwent sacral neuromodulation (SNM) for the treatment of refractory overactive bladder (OAB).

MATERIALS AND METHODS: This study retrospectively reviewed patients who underwent SNM for refractory OAB from 2015 to 2022 at a single institution serving an ethnically diverse and underrepresented community. Demographic data were collected through chart review and surveys conducted via telephone calls. Patient satisfaction and decisional regret was measured with the validated modified SDS-DRS scale (satisfaction with decision scale-decision regret scale). Descriptive statistics, Wilcoxan rank sum, and median regression analyses were performed using STATA 15.0 with p < 0.05 as significant.

RESULTS: Out of 191 patients who underwent SNM, 63 were unreachable (wrong number in chart, number not in service, patient did not answer, deceased). Eighty-nine out of 128 patients reached agreed to participate (70% response rate). The mean time since surgery was 37.3 ±25.2 months. The median satisfaction with decision score was 4.0 (IQR: 3.7-4.7) with a score of 1 correlating with low satisfaction and a score of 5 correlating with high satisfaction. The median decisional regret score was 2.0 (IQR: 1.2-2.9) with a score of 1 correlating with low decisional regret and a score of 5 correlating with strong decisional regret. Ten patients reported complications after surgery, which was significantly associated with lower SDS and higher DRS scores (p < 0.01), and persisted after adjusting for age, body mass index, sex, and comorbidities (SDS β coef: -0.84, 95% CI: -1.5 to 0.15, p = 0.02; DRS β coef: 1.48, 95% CI: 0.55-2.41, p < 0.01).

CONCLUSIONS: Patients who underwent SNM for refractory OAB overall had low regret and high satisfaction with their decision at an average 3 years of follow-up. As expected, those who developed postoperative complications had worse scores. The inclusion of patient-centric outcomes is imperative when determining the success of a surgical procedure and is useful for shared decision-making when advancing to third-line therapy for OAB. Longer-term follow-up is necessary to assess durability of high satisfaction and low regret over time.

PMID:37830272 | DOI:10.1002/nau.25286

J Magn Reson Imaging. 2023 Oct 13. doi: 10.1002/jmri.28998. Online ahead of print.

ABSTRACT

BACKGROUND: The impact of left ventricular mechanical dyssynchrony (LVMD) on the long-term prognosis of ST-segment elevation myocardial infarction (STEMI) is unclear.

HYPOTHESIS: MR uniformity ratio estimates (URE) can detect LVMD and assess STEMI prognosis.

STUDY TYPE: Retrospective analysis of a prospective multicenter registry (EARLY-MYO trial, NCT03768453).

POPULATION: Overall, 450 patients (50 females) with first-time STEMI were analyzed, as well as 40 participants without cardiovascular disease as controls.

FIELD STRENGTH/SEQUENCE: 3.0-T, balanced steady-state free precession cine and late gadolinium enhancement imaging.

ASSESSMENT: MRI data were acquired within 1 week of symptom onset. Major adverse cardiovascular events (MACEs), including cardiovascular death, nonfatal re-infarction, hospitalization for heart failure, and stroke, were the primary clinical outcomes. LVMD was represented by circumferential URE (CURE) and radial URE (RURE) calculated using strain measurements. The patients were grouped according to clinical outcomes or URE values. Patients’ clinical characteristics and MR indicators were compared.

STATISTICAL TESTS: The Student’s t-test, Mann-Whitney U test, chi-square test, Fisher’s exact test, receiver operating characteristic curve analysis with area under the curve, Kaplan-Meier analysis, Cox regression, logistic regression, intraclass correlation coefficient, c-index, and integrated discrimination improvement were used. P < 0.05 was considered statistically significant.

RESULTS: CURE and RURE were significantly lower in patients with STEMI than in controls. The median follow-up was 60.5 months. Patients with both lower CURE and RURE values experienced a significantly higher incidence of MACEs by 3.525-fold. Both CURE and RURE were independent risk factors for MACEs. The addition of UREs improved diagnostic efficacy and risk stratification based on infarct size and left ventricular ejection fraction (LVEF). The indicators associated with LVMD included male sex, serum biomarkers (peak creatine phosphokinase and cardiac troponin I), infarct size, and LVEF.

DATA CONCLUSION: CURE and RURE may be useful to evaluate long-term prognosis after STEMI.

EVIDENCE LEVEL: 4 TECHNICAL EFFICACY: Stage 2.

PMID:37830268 | DOI:10.1002/jmri.28998

Brain Behav. 2023 Oct 13:e3281. doi: 10.1002/brb3.3281. Online ahead of print.

ABSTRACT

OBJECTIVES: In this study, the relationship between preoperative neutrophil-to-lymphocyte ratio (NLR) and Alzheimer-related biomarkers in cerebrospinal fluid (CSF) was investigated to determine whether high NLR is a potential risk factor for postoperative delirium (POD) and to evaluate its predictive efficacy.

METHODS: We selected 1000 patients from the perioperative neurocognitive disorder risk factor and prognosis (PNDRFAP) database and 999 patients from the perioperative neurocognitive disorder and biomarker lifestyle (PNDABLE) database. Patients in the PNDABLE database have been measured for Alzheimer-related biomarkers in CSF (Aβ₄₀ , Aβ₄₂ , P-tau, and tau protein). Mini-mental state examination was used to assess the preoperative mental status of patients. POD was diagnosed using the confusion assessment method and assessed for severity using the memorial delirium assessment scale. Logistic regression analysis was utilized to explore the association of preoperative NLR with POD. What’s more, we also performed sensitivity analysis by adding corrected confounders, and the results were almost unchanged. Spearman’s rank correlation was used to determine the associations between NLR and Alzheimer-related biomarkers. Mediation analyses with 10,000 bootstrapped iterations were used to explore the mediation effects. Finally, we use decision curves and the nomogram model to evaluate the efficacy of preoperative NLR in predicting POD; we also performed external validation using data from Qilu Hospital.

RESULT: Logistic regression results showed that an elevated preoperative NLR was a risk factor for the development of POD in patients (PNDRFAP: OR = 1.067, 95% CI 1.020-1.116; PNDABLE: OR = 1.182, 95% CI 1.048-1.335, p < .05). Spearman’s rank correlation analysis showed a positive but weak correlation between NLR and P-tau/T-tau (R = .065). The mediating effect results indicate that NLR likely mediates the occurrence of POD through elevated tau protein levels (proportion: 47.47%). The results of the box plots showed statistically significant NLR and CSF biomarkers between the POD and non-POD (NPOD) groups (p < .05), with higher NLR, P-tau, and T-tau in the POD group than in the NPOD group. In contrast, the NPOD group had higher Aβ₄₂ levels compared to the POD group. In addition, we used R package to plot the decision curve and nomogram both suggesting a good predictive effect of preoperative NLR on the occurrence of POD.

CONCLUSION: Elevated preoperative NLR levels may be a risk factor for POD and likely mediate the development of POD through elevated P-tau/T-tau levels.

PMID:37830267 | DOI:10.1002/brb3.3281

Ann Surg. 2023 Oct 13. doi: 10.1097/SLA.0000000000006129. Online ahead of print.

ABSTRACT

OBJECTIVE: Defining the role of adjuvant therapy in duodenal adenocarcinoma (DAC) and intestinal subtype ampullary carcinoma (iAC).

SUMMARY BACKGROUND DATA: DAC and iAC share a similar histological differentiation but the benefit of adjuvant therapy remains unclear.

METHODS: Patients undergoing curative-intent surgical resection for DAC and iAC between 2010 and 2021 at five high-volume centers were included. Patient baseline, perioperative and long-term oncological outcomes were evaluated. Statistical testing was performed with SPSS 25 (IBM).

RESULTS: A total of 136 patients with DAC and 171 with iAC were identified. Patients with DAC had more advanced tumors than those with iAC. Median overall survival (OS) in DAC patients was 101 months versus 155 months for iAC patients (P=0.098). DAC had a higher rate of local (14.1% vs. 1.2%, P<0.001) and systemic recurrence (30.4% vs. 3.5%, P<0.001). Adjuvant therapy failed to improve overall survival in all patients with DAC and iAC. For DAC, patients with perineural invasion, but not other negative prognostic factors had improved OS rates with adjuvant therapy (72 m vs. 44 m, P=0.044). IAC patients with N+ (190 m vs. 57 m, P=0.003), T3-4 (177 m vs. 59 m, P=0.050) and perineural invasion (150 m vs. 59 m, P=0.019) had improved OS rates with adjuvant therapy.

CONCLUSION: While adjuvant therapy fails to improve OS in all patients with DAC and iAC in the current study, it improved overall survival in DAC patients with perineural invasion and in iAC patients with T3-4 tumors, positive lymph nodes, and perineural invasion.

PMID:37830246 | DOI:10.1097/SLA.0000000000006129

J Dermatol. 2023 Oct 13. doi: 10.1111/1346-8138.16984. Online ahead of print.

ABSTRACT

Since the COVID-19 outbreak, there have been numerous reports concerning COVID-19 skin manifestations. Debate has ensued as to whether these lesions are unique or represent a form of viral reactivation. The aim of this research was to compare the incidence of herpetic skin lesions between a COVID-19 group, a Sars-CoV-2 mRNA vaccination group, and their respective controls, taking into account their Herpesviridae carrier status. To achieve this goal, the Maccabi Healthcare Services’ database was scanned and cohorts of both verified COVID-19 and mRNA vaccinated patients were extracted and matched to random control groups. Patients with a documented occurrence of any Herpesviridae infection that occurred prior to the studied ‘event’ (i.e., COVID-19 or mRNA vaccination) were regarded as carriers of Herpesviridae. A COVID-19-related or vaccination-related lesion was defined as a clinically diagnosed herpetic lesion appearing 1 month after the index date. In the COVID-19 cohort, there was an insignificant difference in herpetic lesion incidence between the groups. However, logistic regression demonstrated that the interaction of COVID-19 with the Herpesviridae carrier status was statistically significant. For the vaccination cohort, the data showed statistically significant differences between groups in herpetic frequencies, which manifested as an almost 2-fold odds of developing a herpetic lesion. In conclusion, following the analysis of two large cohorts, there is evidence to support the contribution of both COVID-19 and the mRNA vaccine to the reactivation of Herpesviridae. Our results diminish the idea that COVID-19 has unique, herpetic-like lesions.

PMID:37830227 | DOI:10.1111/1346-8138.16984