Category: Statistics

Minerva Surg. 2021 Aug 2. doi: 10.23736/S2724-5691.21.08810-9. Online ahead of print.

ABSTRACT

BACKGROUND: Pudendal nerve block (PNB) is commonly used in pudendal neuralgia (PN) and as an anaesthesiological technique in obstetrical and urological procedures. The purpose of this retrospective study was to compare the efficacy of PNB with other anaesthesiolocal techniques in proctological surgery.

METHODS: A total of 362 patients were seen from a 22 months time interval. Surgical indication was placed after a conservative therapy. 78 patients underwent surgery: 42 with spinal anaesthesia with PNB and 36 with PNB alone according to their anatomical characteristics. All the patients underwent PNB in lithotomy position and with a perirectal approach. The success rate of PNB was evaluated in post operative pain control with the VAS score, after the first and the second evacuation. The follow up also included a third check on the seventh day after surgery.

RESULTS: In post operative period, the mean VAS score found after the first evacuation in patients undergoing PNB was 2.66, after the second evacuation was 1.55, while the VAS score on the seventh day was 0.38. The mean VAS score in the group who underwent spinal anaesthesia and PNB were respectively 3.71 and 1.80 after the first and second evacuation. The VAS score calculated on the seventh day was 0.50. There were no statistically significant differences in the VAS score between the 2 groups (P >0.05).

CONCLUSIONS: PNB may be a valid alternative to spinal anaesthesia in proctological patients. PNB has proven to be both safe and effective technique.

PMID:34338455 | DOI:10.23736/S2724-5691.21.08810-9

Laryngoscope. 2021 Aug 2. doi: 10.1002/lary.29785. Online ahead of print.

ABSTRACT

OBJECTIVES/HYPOTHESIS: Repair of large, recurrent, and complex tracheoesophageal fistulas (TEFs) is challenging and numerous different surgical approaches exist. These various techniques each carry a set of risks and possible complications such as fistula recurrence, tracheal stenosis or pouches, esophageal stenosis, and recurrent laryngeal nerve injury. Slide tracheoplasty is a reconstructive technique successfully used in many different airway pathologies, including TEF repair. This study examines the success, limits, and complications related to slide tracheoplasty for repair of complex TEFs.

STUDY DESIGN: Retrospective chart review.

METHODS: Patients undergoing TEF repair using a cervical or thoracic approach slide tracheoplasty, at a single institution, between July 2008 and December 2019 were retrospectively reviewed. Demographic data, comorbidities, TEF etiology and surgical history, slide tracheoplasty details and outcomes, and postoperative complication data were examined using descriptive statistics.

RESULTS: Twenty-six patients underwent 27 slide tracheoplasties for TEF (20 cervical approaches, 7 thoracic approaches) with a mean age of 5.2 years (IQR 0.7-7.6) at time of surgery. The most common TEF etiologies included congenital (n = 13), tracheostomy tube erosion (n = 5), and button battery ingestion (n = 4). Fistulas ranged in size from <0.5 mm to 4 cm and 59% had previous endoscopic or open repairs. There were two TEF recurrences (7.4%), one of which was successfully revised and the other which was treated with stent placement. Postoperative complications included dehiscence (3.7%), unilateral vocal fold paralysis (3.7%), and mild tracheal stenosis (18.5%).

CONCLUSIONS: Slide tracheoplasty is an effective surgical technique for treating complex congenital and acquired TEFs with lower rates of complications when compared to other techniques.

LEVEL OF EVIDENCE: IV Laryngoscope, 2021.

PMID:34338338 | DOI:10.1002/lary.29785

Diabetes Obes Metab. 2021 Aug 2. doi: 10.1111/dom.14513. Online ahead of print.

ABSTRACT

AIMS: To assess the efficacy and safety of sotagliflozin, a dual inhibitor of sodium-glucose cotransporter 1 and 2, in adults with type 2 diabetes (T2D) and stage 4 chronic kidney disease (CKD4).

MATERIALS AND METHODS: This 52-week, phase 3, randomized (1:1:1), placebo-controlled trial evaluated sotagliflozin 200 and 400 mg once daily in 277 patients with T2D and estimated glomerular filtration rate (eGFR) 15-30 mL/min/1.73 m² . The primary endpoint was HbA1c reduction with sotagliflozin 400 mg vs. placebo at 26 weeks. A hierarchical statistical testing approach was used.

RESULTS: Baseline mean HbA1c was 8.3±1.0%; systolic blood pressure (SBP), 144±15 mmHg; and eGFR, 24±4 mL/min/1.73m² . Placebo-adjusted changes with sotagliflozin 400 mg were -0.3% (95% CI -0.6 to 0.05; P=0.096) and -0.69% (-1.15 to -0.23; P=0.003) in HbA1c at weeks 26 and 52, respectively; -1.5 kg (-3.0 to -0.1) in body weight at week 26; -5.4 mmHg (-9.4 to -1.3) in SBP at week 12; and -0.3 mL/min/1.73m² (-2.1 to 1.6; P=0.776) in eGFR at week 52. Over 52 weeks, 11.8%, 5.4%, and 3.3% patients receiving placebo and sotagliflozin 200 and 400 mg, respectively, required rescue therapy for hyperglycemia. Adverse events occurred in 82.8%, 86.2%, and 81.1% patients and serious cardiovascular adverse events occurred in 12.9%, 3.2%, and 4.4% patients in the placebo and sotagliflozin 200 and 400 mg groups, respectively.

CONCLUSIONS: After 26 weeks, HbA1c reductions with sotagliflozin were not statistically significant vs placebo in adults with T2D and CKD4. The 52-week safety profile was consistent with results of the SCORED outcomes trial (NCT03242018). This article is protected by copyright. All rights reserved.

PMID:34338408 | DOI:10.1111/dom.14513

Stat Med. 2021 Aug 2. doi: 10.1002/sim.9133. Online ahead of print.

ABSTRACT

Multivariable Mendelian randomization (MVMR) is a form of instrumental variable analysis which estimates the direct effect of multiple exposures on an outcome using genetic variants as instruments. Mendelian randomization and MVMR are frequently conducted using two-sample summary data where the association of the genetic variants with the exposures and outcome are obtained from separate samples. If the genetic variants are only weakly associated with the exposures either individually or conditionally, given the other exposures in the model, then standard inverse variance weighting will yield biased estimates for the effect of each exposure. Here, we develop a two-sample conditional F-statistic to test whether the genetic variants strongly predict each exposure conditional on the other exposures included in a MVMR model. We show formally that this test is equivalent to the individual level data conditional F-statistic, indicating that conventional rule-of-thumb critical values of F> 10, can be used to test for weak instruments. We then demonstrate how reliable estimates of the causal effect of each exposure on the outcome can be obtained in the presence of weak instruments and pleiotropy, by repurposing a commonly used heterogeneity Q-statistic as an estimating equation. Furthermore, the minimized value of this Q-statistic yields an exact test for heterogeneity due to pleiotropy. We illustrate our methods with an application to estimate the causal effect of blood lipid fractions on age-related macular degeneration.

PMID:34338327 | DOI:10.1002/sim.9133

Laryngoscope. 2021 Aug 2. doi: 10.1002/lary.29793. Online ahead of print.

ABSTRACT

OBJECTIVES/HYPOTHESIS: Laryngopharyngeal reflux (LPR) has been proposed both as a trigger for recurrent respiratory papillomatosis (RRP) onset and as a factor favoring an aggressive clinical course.

STUDY DESIGN: In this prospective study, 106 participants were recruited within a period of 24 months at the Department of Otorhinolaryngology and Cervicofacial Surgery, University Medical Centre Ljubljana.

METHODS: This study compared a group of RRP patients (N = 36) with a group of LPR patients (N = 28) and a group of healthy participants (N = 42) based on Reflux Symptom Index (RSI), Reflux Finding Scores (RFS), and saliva analyses (pH, pepsin concentration, bile acid concentration, and pepsin enzymatic activity).

RESULTS: The RRP group compared to the LPR group showed a statistically significant difference only in RSI and RFS scores, while the RRP group compared to healthy controls showed significantly higher values in all tested parameters (RSI score, RFS, saliva pH, pepsin concentration, bile acids concentration, pepsin enzymatic activity).

CONCLUSIONS: LPR is common in RRP patients and significantly more prevalent compared to healthy controls. Our results show that saliva analyses are a better office-based tool than RSI questionnaires and RFS scores for diagnosing LPR in RRP patients.

LEVEL OF EVIDENCE: Level 3 Laryngoscope, 2021.

PMID:34338331 | DOI:10.1002/lary.29793

Acta Anaesthesiol Scand. 2021 Aug 2. doi: 10.1111/aas.13965. Online ahead of print.

ABSTRACT

BACKGROUND: The mini-fluid challenge (MFC) is a clinical concept of predicting fluid responsiveness by rapidly infusing a small amount of intravenous fluids, typically 100 ml, and systematically assessing its haemodynamic effect. The MFC method is meant to predict if a patient will respond to a subsequent, larger fluid challenge, typically another 400 ml, with a significant increase in stroke volume.

METHODS: We critically evaluated the general methodology of MFC studies, with statistical considerations, secondary analysis of an existing study, and simulations.

RESULTS: Secondary analysis of an existing study showed that the MFC could predict the total fluid response (MFC + 400 ml) with an area under the receiver operator characteristics curve (AUROC) of 0.92, but that the prediction was worse than random for the response to the remaining 400 ml (AUROC = 0.33). In a null simulation with no response to both the MFC and the subsequent fluid challenge, the commonly used analysis could predict fluid responsiveness with an AUROC of 0.73.

CONCLUSION: Many existing MFC studies are likely overestimating the classification accuracy of the MFC. This should be considered before adopting the MFC into clinical practice. A better study design includes a second, independent measurement of stroke volume after the MFC. This measurement serves as reference for the response to the subsequent fluid challenge.

PMID:34338314 | DOI:10.1111/aas.13965

Am J Phys Anthropol. 2021 Aug 2. doi: 10.1002/ajpa.24381. Online ahead of print.

ABSTRACT

OBJECTIVE: In this study, we analyze breastfeeding and weaning practices in pre-Columbian complex hunter-gatherers from the lower Paraná River basin (South America).

MATERIALS AND METHODS: We carried out bone isotope analyses concerning δ¹³ C in collagen and apatite, the spacing between both carbon sources and δ¹⁵ N in a sample of 23 subadult and adult individuals of both sexes recovered from Late Holocene archaeological sites, ranging from 1665 ± 45 to 680 ± 80 ¹⁴ C years BP.

RESULTS AND DISCUSSION: The results indicate that exclusive breastfeeding continued until the age of ~2 years, and weaning probably until 4 years of age. Supplementary foods included C₃ plants and probably animal fats and C₄ carbohydrates. A high fractionation of 4.9‰ in δ¹⁵ N values was recognized between breastfeeding infants and adult females, perhaps reflecting episodic hyper-protein diets in women linked to men’s food provisioning during women’s gestational/postpartum period. Additionally, male adults present a higher protein intake than females. Although this difference is not statistically significant with the current sample size, it could be a clue related to a sexual division in food procurement.

PMID:34338320 | DOI:10.1002/ajpa.24381

Indian Pediatr. 2021 Aug 2:S097475591600359. Online ahead of print.

ABSTRACT

BACKGROUND: Multiple studies have documented lower serum zinc levels in patients with febrile seizures in comparison to febrile patients without seizure. However, there is limited evidence comparing the effects of zinc supplementation with placebo on recurrence of febrile seizures in children.

OBJECTIVES: To study the effects of zinc supplementation on recurrence rate of febrile seizures in children less than 60 months of age.

DESIGN: Systematic review and meta-analysis of randomized and quasi-randomized controlled trials.

DATA SOURCE AND SELECTION CRITERIA: We searched PubMed, EMBASE and CENTRAL databases for articles reporting randomized or quasi-randomized controlled trials comparing the effects of zinc supplementation with placebo on recurrence of febrile seizures in children aged less than 60 months. We performed a fixed effect meta-analysis to provide pooled odds ratio of febrile seizure recurrence. Quality of evidence was assessed using GRADE approach.

PARTICIPANTS: Children aged less than 60 months.

INTERVENTION: Zinc supplementation.

OUTCOME MEASURES: Odds of febrile seizure recurrence.

RESULTS: Four clinical trials with a total of 350 children were included in the review. There was no statistically significant difference between odds of febrile seizure recurrence during one year follow up, in children on zinc supplementation compared to those on placebo (OR 0.70; 95% CI 0.41 – 1.18, I2 = 0%).

CONCLUSION: Available evidence is very low quality and thus inadequate to make practice recommendations.

PMID:34338220

Laryngoscope. 2021 Aug 2. doi: 10.1002/lary.29750. Online ahead of print.

ABSTRACT

OBJECTIVES/HYPOTHESIS: The objective of this study was to compare ventilation techniques utilized in microlaryngeal surgery.

STUDY DESIGN: Retrospective cohort study.

METHODS: Two-hundred surgeries performed from May 1, 2018 to March 1, 2020 and stratified as intubated, intermittently intubated (AAIV) or apneic. Patient demographics, comorbidities, anesthetic agents, intraoperative parameters/events, and complications were studied and compared across the three groups using inferential analyses.

RESULTS: Median body mass index in the AAIV group was significantly higher (33 vs. 29; P = .0117). Median oxygen nadirs were lower in AAIV cases (81% vs. 91-92%) while CO₂ peak measurements were lower (33 mmHg vs. 48 mmHg) in the fully apneic cohort which were significantly shorter cases (P < .0001). CO₂ peak measurements were comparable between AAIV and intubated cohorts (median 48.5 mmHg vs. 48.0 mmHg). Median apnea times were significantly prolonged by 2-5.5 minutes using nasal cannula and THRIVE/Optiflow in fully apneic cases when compared to no supplementary oxygenation (P = .0013). Systolic blood pressures following insertion of laryngoscope were higher (159.5 vs. 145 mmHg) and postoperative diastolic pressures were lower (68.5 vs. 76.5 mmHg) in fully apneic cases than intubated cases. No differences existed between frequencies of complications.

CONCLUSIONS: This study compares intubated, intermittently apneic, and fully apneic surgeries. No statistically significant differences were noted in comorbid conditions. While intraoperative hemodynamic fluctuations were more pronounced in the fully apneic cohort, and oxygenation distributions were lower in the AAIV cohort, no significant differences existed between events and complications. Apneic techniques are as safe and effective as traditional intubation.

LEVEL OF EVIDENCE: 4 Laryngoscope, 2021.

PMID:34338303 | DOI:10.1002/lary.29750

F1000Res. 2021 Feb 5;10:77. doi: 10.12688/f1000research.28002.1. eCollection 2021.

ABSTRACT

Background: The giant African snail, Achatina fulica, is an invasive species recognized for being a serious agricultural pest and an intermediary vector for diverse parasites that cause diseases in humans. The knowledge of the state of African snail populations in urban areas is of great ecological and public health importance. Therefore, our objective was to characterize the status of giant African snail populations present in the city of Cartagena, Colombia, including the assessment of nematode parasites in the specimens. Methods. Sites were visited following information from citizens affected by the presence of the African snail. The specimens were collected and transported to the laboratory; subsequently, they were weighed, measured, and classified by size. Dissections of lung tissue and soft organs were performed to search for and identify nematode parasites. Size measurement between the sampled sites was statistically compared and density and biomass indicators were established. Results. In total, 204 snails were collected distributed among four sites within Cartagena city. Of these, 50% were juvenile specimens (10-40 mm). The size of the specimens showed significant differences between the sampling areas. The calculated density was between 0.0019-0.68 ind/m ² and the biomass between 3.92-48.75 kg/ha. No presence of nematode parasites was observed in these specimens. Conclusions. Densities and biomasses of A. fulica in Cartagena do not reach levels considered highly harmful. On the other hand, although no parasites were found in these snails, it is relevant to continue with studies on the human health risks that represent the presence of this invasive species in urban areas of Cartagena.

PMID:34336187 | PMC:PMC8280942 | DOI:10.12688/f1000research.28002.1