Category: Statistics

Surg Technol Int. 2021 Aug 5;39:sti39/1470. Online ahead of print.

ABSTRACT

INTRODUCTION: Prior publications have demonstrated chemical and physical alteration of hernia mesh analyzed after explantation from the body. The specific alteration documented is oxidative degradation of polypropylene mesh fibers. An animal study recently published has demonstrated that adipose tissue attachment is present instead of reparative fibrous tissue infiltration in an average of 10.9-18.9% of the intramesh healing for a variety of clinically used knitted polypropylene mesh products; 8.0% for knitted polyester meshes. This study also found that in comparison to the knitted mesh products, non-woven polypropylene mesh reduced adipose tissue attachment to 1% or less, which was a statistically significant difference.

MATERIALS AND METHODS: Samples of explanted polypropylene mesh from eight patients were analyzed for the presence of adipose tissue attachment, reparative fibrous tissue infiltration, and oxidative changes. Greater adipose tissue attachment areas were compared with areas of greater reparative fibrous tissue infiltration for evidence of oxidative changes in the mesh to determine if the areas of higher adipose tissue attachment correlated with an increase in oxidative changes.

RESULTS: Intra mesh healing of clinically explanted knitted meshes demonstrated adipose tissue content from 0.0% to 49.1% per analyzed segment. The oxidation index, a measure of the degree of oxidative degradation in that portion of the mesh, was higher in seven of the eight areas of greater adipose tissue attachment than areas of greater reparative fibrous tissue infiltration.

CONCLUSION: Adipose tissue attachment does occur in knitted and woven polypropylene hernia meshes. The presence of adipose tissue may contribute to an increase in oxidative changes in knitted polypropylene hernia mesh fibers.

PMID:34352925

Arch Plast Surg. 2021 Jul;48(4):366-372. doi: 10.5999/aps.2020.02152. Epub 2021 Jul 15.

ABSTRACT

BACKGROUND: The result of illicit polymer injection is chronic inflammation with foreign-body granuloma (FBG) formation. Treatment can be divided into medical and surgical. Some patients develop severe complications with need surgical treatment. This study aims to describe patients who underwent surgical removal of the FBGs and autoimmune/inflammatory syndrome induced by adjuvants (ASIA); additionally, we evaluated the quality of life after surgery.

METHODS: In this retrospective single-center study, the authors examined data of patients who underwent surgical removal of FBG caused by illicit polymer injection for cosmetic purposes and confirmed ASIA from 2015 to 2020 by three different surgical approaches. Descriptive summary statistics were reported on patient demographics, presenting symptoms and clinical examination features, treatment strategies, histopathology reports and quality of life.

RESULTS: The cohort included 11 female patients with FBGs and ASIA. The most affected anatomical zones were the combination of gluteal region, thighs and legs (40%); and thighs with legs (20%). Main presentation was: skin hyperpigmentation (90.9%), skin induration (63.6%), chronic fatigue (63.6%), and ulcers (36.4%). Surgical modalities consisted of: ultrasonic-assisted liposuction in four patients (36.4%); open en bloc excision and primary closure in four patients (36.4%); and open en bloc excision and microsurgical reconstruction in three patients (27.2%). The postoperative quality of life visual analog scale score was 83.9.

CONCLUSIONS: ASIA treatment represents a challenge for the plastic surgeon. Adequate surgical treatment emphasizing, when possible, the total or near-total resection of the FBG must be performed to improve ASIA evolution.

PMID:34352946 | DOI:10.5999/aps.2020.02152

Adv Nutr. 2021 Aug 5:nmab093. doi: 10.1093/advances/nmab093. Online ahead of print.

ABSTRACT

High-glycemic index (high-GI) foods (so-called fast carbs) have been hypothesized to promote fat storage and increase risk of obesity. To clarify whether dietary GI impacts body weight, we searched PubMed and the Cochrane Database of Systematic Reviews for observational studies reporting associations between BMI and dietary GI, and for meta-analyses of randomized controlled trials (RCTs) comparing low-GI and high-GI diets for weight loss. Data on 43 cohorts from 34 publications, totaling 1,940,968 adults, revealed no consistent differences in BMI when comparing the highest with the lowest dietary GI groups. In the 27 cohort studies that reported results of statistical comparisons, 70% showed that BMI was either not different between the highest and lowest dietary GI groups (12 of 27 cohorts) or that BMI was lower in the highest dietary GI group (7 of 27 cohorts). Results of 30 meta-analyses of RCTs from 8 publications demonstrated that low-GI diets were generally no better than high-GI diets for reducing body weight or body fat. One notable exception is that low-GI diets with a dietary GI at least 20 units lower than the comparison diet resulted in greater weight loss in adults with normal glucose tolerance but not in adults with impaired glucose tolerance. While carbohydrate quality, including GI, impacts many health outcomes, GI as a measure of carbohydrate quality appears to be relatively unimportant as a determinant of BMI or diet-induced weight loss. Based on results from observational cohort studies and meta-analyses of RCTs, we conclude that there is scant scientific evidence that low-GI diets are superior to high-GI diets for weight loss and obesity prevention.

PMID:34352885 | DOI:10.1093/advances/nmab093

Am J Perinatol. 2021 Aug 5. doi: 10.1055/s-0041-1732379. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to evaluate maternal and neonatal outcomes by method of cervical ripening for labor induction among low-risk nulliparous individuals.

STUDY DESIGN: This is a secondary analysis of a multicenter randomized trial of labor induction at 39 weeks versus expectant management in low-risk nulliparous participants. Participants undergoing cervical ripening for labor induction in either group were included. Participants were excluded for preripening membrane rupture, abruption, chorioamnionitis, fetal demise, or cervical dilation ≥3.5 cm. Cervical ripening was defined by the initial method used: prostaglandin only (PGE; referent), Foley with concurrent prostaglandin (Foley-PGE), Foley only (Foley), and Foley with concurrent oxytocin (Foley-oxytocin). Coprimary outcomes were adverse maternal and neonatal composites. Secondary outcomes included cesarean delivery and length of labor and delivery (L&D) stay. Multivariable analysis was used to adjust for patient characteristics.

RESULTS: Of 6,106 participants included in the trial, 2,376 (38.9%) met criteria for this analysis. Of these, 1,247 (52.4%) had cervical ripening with PGE, 290 (12.2%) had Foley-PGE, 385 (16.2%) had Foley, and 454 (19.1%) had Foley-oxytocin. The maternal composite outcome was similar among participants who received Foley-PGE (24.1%, adjusted relative risk [aRR] = 1.21, 95% confidence interval [CI]: 0.96-1.52), Foley (21.3%, aRR = 1.16, 95% CI: 0.92-1.45), or Foley-oxytocin (19.4%, aRR = 1.04, 95% CI: 0.83-1.29), compared with PGE (19.7%). The neonatal composite outcome was less frequent in participants who received the Foley-PGE (2.4%, aRR = 0.35, 95% CI: 0.16-0.75) or Foley (3.6%, aRR = 0.51, 95% CI: 0.29-0.89) but did not reach statistical significance for participants who received Foley-oxytocin (4.6%, aRR = 0.63, 95% CI: 0.40-1.01) compared with PGE only (6.8%). Participants who received Foley-PGE or Foley-oxytocin had a shorter L&D stay (adjusted mean difference = -1.97 hours, 95% CI: -3.45 to -0.49 and -5.92 hours, 95% CI: -7.07 to -4.77, respectively), compared with PGE.

CONCLUSION: In term low-risk nulliparous participants, Foley alone or concurrent with PGE is associated with a lower risk of adverse neonatal outcomes than with PGE alone. Length of L&D stay was the shortest with concurrent Foley-oxytocin.

KEY POINTS: · Adverse maternal outcomes are similar among different methods of cervical ripening in low-risk women.. · Adverse neonatal outcomes are less frequent with use of Foley alone or in combination with PGE.. · The use of Foley alone, or in combination with other agents, appears to be beneficial..

PMID:34352922 | DOI:10.1055/s-0041-1732379

Am J Perinatol. 2021 Aug 5. doi: 10.1055/s-0041-1733784. Online ahead of print.

ABSTRACT

OBJECTIVE: Retosiban, an oxytocin receptor antagonist, was developed for treating spontaneous preterm labor (sPTL) in women with intact membranes. This ARIOS follow-up study aimed to characterize clinical safety, morbidity, and mortality of infants exposed to retosiban or comparator over 2 years.

STUDY DESIGN: ARIOS prospectively assessed outcomes in infants whose mothers received at least one dose of retosiban or comparator (placebo/atosiban) in two Phase 3 sPTL trials. Both trials were terminated prematurely owing to poor enrolment. Infants could be enrolled into ARIOS from 28 days after estimated due date until hospital discharge or up to 9 months (corrected age). An internally developed questionnaire detailing medical conditions, mortality and resource use (Child Health Inventory; CHI), Ages and Stages Questionnaire-3 (ASQ-3), Modified Checklist for Autism in Toddlers-Revised with Follow-Up, and Child Behavior Checklist for Ages 1.5 to 5 were completed remotely by parents or legal guardians at prespecified intervals. Serious adverse events (SAEs) were primarily captured via CHI. No comparative statistical analysis was conducted between treatment arms.

RESULTS: A total of 49 (86%) infants who had received retosiban and 49 (78%) infants who had received a comparator were enrolled in ARIOS. No deaths occurred during the study. Nine infants experienced SAEs: 6/49 (12.2%) infants in the comparators group and 3/49 (6.1%) in the retosiban group. Of the nine SAEs, seven were due to infections, three, and four in the retosiban and comparators groups, respectively. Based on ASQ-3 score, the incidence of neurodevelopmental delay at 18 and 24 months were 0/18 (0%) and 2/25 (8%) with retosiban and 7/22 (31.8%) and 3/21 (14.3%) with comparator, respectively.

CONCLUSION: The current study showed no unexpected adverse outcome or impairment with retosiban based on safety monitoring and neurodevelopment assessments. No further follow-up is intended owing to the discontinuation of clinical development of retosiban.

KEY POINTS: · There is a need for an effective and safe treatment for sPTL.. · ARIOS was a follow-up study of two Phase 3 trials in sPTL.. · There were no safety concerns with retosiban treatment.. · Slow recruitment led to termination of the Phase 3 trials..

PMID:34352924 | DOI:10.1055/s-0041-1733784

Cir Cir. 2021;89(4):443-448. doi: 10.24875/CIRU.20000495.

ABSTRACT

OBJETIVO: Evaluar los resultados funcionales y el impacto en la calidad de vida de pacientes con parálisis cordal unilateral en abducción (PCUA) de etiología variable, posoperados de tiroplastia de medialización con técnica de Netterville en el Instituto Nacional de Rehabilitación.

MÉTODO: En los pacientes candidatos a tiroplastia de medialización se documentaron el tiempo máximo fonatorio y cuestionarios de funcionalidad (VHI-30) y calidad de vida (VRQoL) prequirúrgicos y 3 a 6 meses posquirúrgicos. Se utilizaron pruebas de comparación de medias para analizar los resultados.

RESULTADOS: Se realizó tiroplastia de medialización en 27 pacientes con PCUA de 2013 a 2019. Todos tuvieron mejoría estadística y clínicamente significativa por el tiempo máximo fonatorio (media de 4.07 a 11.07 segundos), el VHI-30 (media de 81 a 29 puntos) y la VRQoL (media de 33 a 15 puntos). No se documentó ninguna complicación mayor.

CONCLUSIONES: La tiroplastia de medialización es un tratamiento seguro que mejora de manera significativa la calidad de vida y la funcionalidad de los pacientes con PCUA.

OBJECTIVE: To evaluate functional and quality of life results in patients with unilateral vocal fold paralysis (UVFAP) of different etiology, who underwent medialization thyroplasty, using Netterville’s technique.

METHOD: In patients eligible for medialization thyroplasty, maximum phonatory time was measured, quality of life (VRQoL) and functionality (VHI-30) questionnaires were applied before surgery and posteriorly at 3 and 6 months after surgery. Means comparison tests were used to analyze the results.

RESULTS: Medialization thyroplasty was carried out in 27 patients presenting with UVFAP from 2013 to 2019. All had a statistically significant and clinically significant improvement. This was measure with maximum phonatory time (medium of 4.07 to 11.07 seconds), VHI-30 (medium of 81 to 29 points), and VRQoL (medium of 33 to 15 points). No mayor complications were documented.

CONCLUSIONS: Medialization thyroplasty is a safe procedure that significantly improves functionality and quality of life in patients with UVFAP.

PMID:34352871 | DOI:10.24875/CIRU.20000495

PLoS One. 2021 Aug 5;16(8):e0255784. doi: 10.1371/journal.pone.0255784. eCollection 2021.

ABSTRACT

As human pressures on the environment continue to spread and intensify, effective conservation interventions are direly needed to prevent threats, reduce conflicts, and recover populations and landscapes in a liaison between science and conservation. It is practically important to discriminate between true and false (or misperceived) effectiveness of interventions as false perceptions may shape a wrong conservation agenda and lead to inappropriate decisions and management actions. This study used the false positive risk (FPR) to estimate the rates of misperceived effectiveness of electric fences (overstated if reported as effective but actually ineffective based on FPR; understated otherwise), explain their causes and propose recommendations on how to improve the representation of true effectiveness. Electric fences are widely applied to reduce damage to fenced assets, such as livestock and beehives, or increase survival of fenced populations. The analysis of 109 cases from 50 publications has shown that the effectiveness of electric fences was overstated in at least one-third of cases, from 31.8% at FPR = 0.2 (20% risk) to 51.1% at FPR = 0.05 (5% risk, true effectiveness). In contrast, understatement reduced from 23.8% to 9.5% at these thresholds of FPR. This means that truly effective applications of electric fences were only 48.9% of all cases reported as effective, but truly ineffective cases were 90.5%, implying that the effectiveness of electric fences was heavily overstated. The main reasons of this bias were the lack of statistical testing or improper reporting of test results (63.3% of cases) and interpretation of marginally significant results (p < 0.05, p < 0.1 and p around 0.05) as indicators of effectiveness (10.1%). In conclusion, FPR is an important tool for estimating true effectiveness of conservation interventions and its application is highly recommended to disentangle true and false effectiveness for planning appropriate conservation actions. Researchers are encouraged to calculate FPR, publish its constituent statistics (especially treatment and control sample sizes) and explicitly provide test results with p values. It is suggested to call the effectiveness “true” if FPR < 0.05, “suggestive” if 0.05 ≤ FPR < 0.2 and “false” if FPR ≥ 0.2.

PMID:34352882 | DOI:10.1371/journal.pone.0255784

Obstet Gynecol. 2021 Aug 5. doi: 10.1097/AOG.0000000000004515. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the relationship between umbilical artery cord gas values and fetal tolerance of labor, as reflected by Apgar score. We hypothesized the existence of wide biological variability in fetal tolerance of metabolic acidemia, which, if present, would weaken one fundamental assumption underlying the use of electronic fetal heart rate (FHR) monitoring.

METHODS: We conducted a retrospective cohort study of term, singleton, nonanomalous fetuses delivered in our institution between March 2012 and July 2020. Universally obtained umbilical cord gas values and Apgar scores were extracted. We calculated Spearman correlation coefficients and receiver operating characteristic curves for various levels of umbilical artery pH, base excess, and Apgar scores.

RESULTS: We analyzed data from 29,787 deliveries. The statistical correlation between umbilical artery pH and base excess and both 1- and 5-minute Apgar scores was weak or nonexistent in all pH range subgroups (range 0.064-0.213). Receiver operating characteristic curve analysis suggested umbilical artery pH value of 7.22 yields the best discrimination for prediction of a severely depressed newborn (5-minute Apgar score less than 4), but sensitivity and specificity for this predictive value remains poor to moderate.

CONCLUSION: The use of electronic FHR monitoring is predicated on a documented relationship between FHR patterns and umbilical artery pH, and an assumed correlation between pH and fetal outcomes, reflecting fetal tolerance of labor and delivery. Our data demonstrate a weak-to-absent correlation between metabolic acidemia and even short-term fetal condition, thus significantly weakening this latter assumption. No amount of future modification of FHR pattern interpretation to better predict newborn pH is likely to lead to improved newborn outcomes, given this weakness in a fundamental assumption on which FHR monitoring is based.

PMID:34352847 | DOI:10.1097/AOG.0000000000004515

Cir Cir. 2021;89(4):520-527. doi: 10.24875/CIRU.200007601.

ABSTRACT

OBJETIVO: Determinar la tasa de recurrencia del cáncer de próstata localizado después de la prostatectomía radical según la clasificación D’Amico.

MÉTODOS: Estudio de cohorte retrospectivo comparativo de 5 años. Se obtuvieron datos de registros clínicos de pacientes con cáncer de próstata localizado, que se sometieron a prostatectomía radical y se evaluó la tasa de recurrencia de la enfermedad. Se analizó con pruebas estadísticas descriptivas y comparativas. Una p < 0.05 se consideró significativo.

RESULTADOS: Se analizó 108 pacientes, la edad promedio 65.3 años. Acerca de la clasificación de riesgo de D’Amico, 33.33% de bajo riesgo, 55.56% riesgo intermedio y 11.11% alto riesgo. La tasa de recurrencia de APE fue 14,81%. Los pacientes de bajo riesgo tuvieron recurrencia del 13.89%, riesgo intermedio 18.33% y alto riesgo no tuvieron recurrencia. Sobre piezas quirúrgicas, el 25.93% presentaron características adversas. La escala de Gleason postoperatoria muestra un aumento de 44.44% en bajo riesgo, 26.67% en riesgo intermedio y 41.67% en alto riesgo.

CONCLUSIONES: La prostatectomía radical ofrece un control adecuado del cáncer de próstata localizado. La tasa de recurrencia del APE fue menor que otros informes internacionales. Asimismo, la recurrencia bioquímica del riesgo bajo, intermedio y alto fue similar a la tendencia global.

OBJECTIVE: The objective of the study was to determine the recurrence rate of localized prostate cancer after radical prostatectomy according to the D’Amico classification.

METHODS: This was a observational and 5-year comparative retrospective cohort study. Data were obtained from clinical records of patients with localized prostate cancer who underwent radical prostatectomy and the recurrence rate of the disease was evaluated. It was analyzed with descriptive and comparative statistical tests, p<0.05 was considered significant.

RESULTS: One hundred and eight patients were analyzed, and the average age was 65.3 years. About D’Amico’s risk classification, 33.33% low risk, 55.56% intermediate risk, and 11.11% high risk. The prostate-specific antigen (PSA) recurrence rate was 14.81%. Low-risk patients had recurrence of 13.89%, intermediate risk 18.33%, and high risk had no recurrence. Regarding surgical pieces, 25.93% presented adverse characteristics. The post-operative Gleason scale shows an increase of 44.44% in low risk, 26.67% in intermediate risk, and 41.67% in high risk.

CONCLUSIONS: Radical prostatectomy offers adequate control of localized prostate cancer. The PSA recurrence rate was lower than other international reports. Likewise, the biochemical recurrence of low, intermediate, and high risk was similar to the global trend.

PMID:34352860 | DOI:10.24875/CIRU.200007601

Invest Radiol. 2021 Aug 4. doi: 10.1097/RLI.0000000000000813. Online ahead of print.

ABSTRACT

OBJECTIVES: Chest radiographs (CXRs) are commonly performed in emergency units (EUs), but the interpretation requires radiology experience. We developed an artificial intelligence (AI) system (precommercial) that aims to mimic board-certified radiologists’ (BCRs’) performance and can therefore support non-radiology residents (NRRs) in clinical settings lacking 24/7 radiology coverage. We validated by quantifying the clinical value of our AI system for radiology residents (RRs) and EU-experienced NRRs in a clinically representative EU setting.

MATERIALS AND METHODS: A total of 563 EU CXRs were retrospectively assessed by 3 BCRs, 3 RRs, and 3 EU-experienced NRRs. Suspected pathologies (pleural effusion, pneumothorax, consolidations suspicious for pneumonia, lung lesions) were reported on a 5-step confidence scale (sum of 20,268 reported pathology suspicions [563 images × 9 readers × 4 pathologies]) separately by every involved reader. Board-certified radiologists’ confidence scores were converted into 4 binary reference standards (RFSs) of different sensitivities. The RRs’ and NRRs’ performances were statistically compared with our AI system (trained on nonpublic data from different clinical sites) based on receiver operating characteristics (ROCs) and operating point metrics approximated to the maximum sum of sensitivity and specificity (Youden statistics).

RESULTS: The NRRs lose diagnostic accuracy to RRs with increasingly sensitive BCRs’ RFSs for all considered pathologies. Based on our external validation data set, the AI system/NRRs’ consensus mimicked the most sensitive BCRs’ RFSs with areas under ROC of 0.940/0.837 (pneumothorax), 0.953/0.823 (pleural effusion), and 0.883/0.747 (lung lesions), which were comparable to experienced RRs and significantly overcomes EU-experienced NRRs’ diagnostic performance. For consolidation detection, the AI system performed on the NRRs’ consensus level (and overcomes each individual NRR) with an area under ROC of 0.847 referenced to the BCRs’ most sensitive RFS.

CONCLUSIONS: Our AI system matched RRs’ performance, meanwhile significantly outperformed NRRs’ diagnostic accuracy for most of considered CXR pathologies (pneumothorax, pleural effusion, and lung lesions) and therefore might serve as clinical decision support for NRRs.

PMID:34352804 | DOI:10.1097/RLI.0000000000000813