Category: Statistics

J Korean Neurosurg Soc. 2021 Sep 8. doi: 10.3340/jkns.2021.0056. Online ahead of print.

ABSTRACT

OBJECTIVE: COVID-19 has spread worldwide since the first case was reported in Wuhan, China, in December 2019. Our institution is a regional trauma and emergency center in the northern Gyeonggi Province. The changing trend of patient care in the emergency room of this hospital likely reflects the overall trend of patients in the area. In the present study, whether changes in the surrounding social environment following the outbreak of COVID-19 changed the incidence of neurosurgical emergency patients and whether differences in practice existed were investigated.

METHODS: The overall trend was analyzed from January 2020 which is before the outbreak of COVID-19 to September 2020. To remove bias due to seasonal variation, the previous 2 year’s records during the same period were reviewed and compared. Confirmed COVID-19 patients in the northern Gyeonggi Province were identified using data released by the government. And patients who came to the emergency department with head trauma and stroke were identified.

RESULTS: Based on the present study results, the total number of neurosurgery emergency patients decreased over the study period. In the trauma patient group, the number of patients not involved in traffic accidents significantly decreased compared with patients involved in traffic accidents. Among the stroke cases, the rate of ischemic stroke was lower than hemorrhagic stroke, although a statistically significant difference was not observed. Meanwhile, an increase in the risk of mortality associated with trauma or stroke cases was not observed during the COVID-19 outbreak compared with the same time period in the previous year.

CONCLUSION: Due to the occurrence of COVID-19, non-essential activities have decreased and trauma cases not associated with traffic accidents appeared to decrease. Due to the decrease in overall activity, the number of stroke patients has also decreased. This trend is expected to continue even in the post-COVID-19 era, and accordingly, the results from the present study are relevant especially if the current situation continues.

PMID:34492750 | DOI:10.3340/jkns.2021.0056

Am J Perinatol. 2021 Sep 7. doi: 10.1055/s-0041-1735220. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to examine the epidemiology of antibiotic exposure and early onset sepsis (EOS) in late preterm and term infants born via cesarean section with rupture of membranes less than 10 minutes.

STUDY DESIGN: Retrospective review of 1,187 late preterm and term infants born at Brooke Army Medical Center between January 1, 2012 and August 29, 2019. Subjects were assessed for factors related to antibiotic treatment. Statistical analysis was performed to compare infants treated with antibiotics versus observation.

RESULT: An early blood culture was obtained from 234 (19.7%) infants; 170 (14.3%) were treated with antibiotics. Infants treated with antibiotics were significantly younger (p < 0.0001), smaller (p < 0.0001), more often diagnosed with respiratory distress (p < 0.0001), and were more frequently admitted to the neonatal intensive care unit (p < 0.0001). There were no cases of culture proven EOS.

CONCLUSION: Although this population lacks risk factors for the development of EOS, a significant percentage was treated with antibiotics. This population may benefit from future antibiotic stewardship efforts.

KEY POINTS: · This population is at risk for respiratory morbidity.. · There were no cases of culture proven early onset sepsis.. · This is a group of interest for antibiotic stewardship..

PMID:34492723 | DOI:10.1055/s-0041-1735220

Homeopathy. 2021 Sep 7. doi: 10.1055/s-0041-1731383. Online ahead of print.

ABSTRACT

INTRODUCTION: Plantar fasciitis (PF) is a chronic degenerative condition causing marked thickening and fibrosis of the plantar fascia, and collagen necrosis, chondroid metaplasia and calcification. There is little convincing evidence in support of various approaches, including homeopathy, for treating PF. This study was undertaken to examine the efficacy of individualized homeopathic medicines (IHMs) compared with placebo in the treatment of PF.

METHODS: A double-blind, randomized, placebo-controlled trial was conducted at the outpatient departments of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, West Bengal, India. Patients were randomized to receive either IHMs or identical-looking placebo in the mutual context of conservative non-medicinal management. The Foot Function Index (FFI) questionnaire, as an outcome measure, was administered at baseline, and every month, up to 3 months. Group differences (unpaired t-tests) and effect sizes (Cohen’s d) were calculated on an intention-to-treat sample. The sample was analyzed statistically after adjusting for baseline differences.

RESULTS: The target sample size was 128; however, only 75 could be enrolled (IHMs: 37; Placebo: 38). Attrition rate was 9.3% (IHMs: 4, Placebo: 3). Differences between groups in total FFI% score favored IHMs against placebo at all the time points, with large effect sizes: month 1 (mean difference, -10.0; 95% confidence interval [CI], -15.7 to -4.2; p = 0.001; d = 0.8); month 2 (mean difference, -14.3; 95% CI, -20.4 to -8.2; p <0.001; d = 1.1); and month 3 (mean difference, -23.3; 95% CI, -30.5 to -16.2; p <0.001; d = 1.5). Similar significant results were also observed on three FFI sub-scales (pain%, disability%, and activity limitation%). Natrum muriaticum (n = 14; 18.7%) and Rhus toxicodendron and Ruta graveolens (n = 11 each; 14.7%) were the most frequently prescribed medicines. No harms, serious adverse events, or intercurrent illnesses were recorded in either of the groups.

CONCLUSION: IHMs acted significantly better than placebo in the treatment of PF; however, the trial being underpowered, the results should be interpreted as preliminary only. Independent replications are warranted.

TRIAL REGISTRATION: CTRI/2018/10/016014.

PMID:34492725 | DOI:10.1055/s-0041-1731383

J Reconstr Microsurg. 2021 Sep 7. doi: 10.1055/s-0041-1735508. Online ahead of print.

ABSTRACT

INTRODUCTION: In breast surgery, an autologous flap combined with implant may reduce the risk or repair the soft-tissue defects in several cases. Traditionally, the preferred flap is the myocutaneous latissimus dorsi (LD) flap. In the perforator flap era, the evolution of LD flap is the thoracodorsal artery perforator (TDAP) flap. The aim of this study is the comparison between LD flap and TDAP flap with implants in terms of early complications and shoulder function.

METHODS: We performed a retrospective cohort study in accordance with the STROBE guidelines. Between January 1 2015 and January 1 2020, 27 women underwent a unilateral total breast reconstruction with LD or TDAP flap combined with an implant at our institution. 15 women were operated with LD flap and 12 with TDAP flap. The most frequent indications for intervention were results of mastectomy and radiation-induced contracture. We evaluated several data in terms of clinical and demographical characteristics, operative and perioperative factors, and follow-up variables. We assessed shoulder function through the Disability of the Arm, Shoulder and Hand Questionnaire (DASH).

RESULTS: The rate of complications was significantly lower in the TDAP group compared with the LD group (16.7% vs 60.0%, p = 0.047. Table 3). Although the small sample size limited further detailed statistical analyses, we particularly noticed no cases of donor site seroma in the TDAP group, as compared with four in the LD group. Patients in the TDAP group had an ∼11-point lower mean DASH score compared with the LD group (9.8 vs 20.5). This difference was statistically significant (p = 0.049).

CONCLUSIONS: TDAP flap seems to be a reliable technique for soft-tissue coverage in total breast reconstruction with implants. In comparison with the traditional LD flap, it could be a more favorable option in terms of less complications and better quality of life.

PMID:34492716 | DOI:10.1055/s-0041-1735508

Sportverletz Sportschaden. 2021 Sep 7. doi: 10.1055/a-1532-4597. Online ahead of print.

ABSTRACT

BACKGROUND: There is a gap in the literature regarding predictors of rowing performance in young rowers. Therefore, the aim of this study was to investigate associations between parameters of biological maturity, body constitution and physical fitness with rowing performance in young female elite rowers.

METHODS: A total of 26 female rowers aged 13.1 ± 0.5 years (maturity offset: + 2.2 ± 0.5 years from peak height velocity; training volume: 10 hours/week) volunteered to participate in this study. During the performance tests in March 2016/2017, biological maturity (e. g. maturity offset), body constitution (e. g. body height/mass, lean body mass, body fat mass) and physical fitness were assessed. Physical fitness tests included the assessment of muscle strength (1-RM bench pull, leg press, maximal handgrip strength), muscle power (standing long jump test), muscular endurance (trunk muscle endurance test [Bourban test]), dynamic balance (Y-balance test) and change-of-direction speed (multistage shuttle run). Finally, rowing performance was analysed using a 700-m rowing ergometer test. A linear regression analysis was computed for the models (1) biological maturity, (2) biological maturity and body constitution, and (3) biologic maturity, body constitution, and physical fitness.

RESULTS: The statistical analysis showed significant (p≤ 0.01) medium-to-large sized correlations (0.57 ≤r≤ 0.8) between biological maturity, body constitution (e. g. body height/mass, lean body mass) and physical fitness (e. g. 1-RM bench pull, maximal handgrip strength, Bourban test) with rowing performance. Model 3 with the predictors body constitution (i. e. lean mass) and muscular endurance (i. e. Bourban test) showed the largest explained variance for 700-m rowing ergometer performance (R² = 0.94, Akaike information criterion [AIC] = 82.1). Explained variance of model 3 was higher compared with model 1 (R² = 0.6, AIC = 131.5) and model 2 (R² = 0.63, AIC = 111.6).

CONCLUSIONS: As a result of this study, coaches involved in junior rowing should focus on characteristics such as biological maturity, body constitution and physical fitness (muscle strength, muscular endurance) during talent development as these correlated highly with rowing ergometer performance.

PMID:34492718 | DOI:10.1055/a-1532-4597

Am J Perinatol. 2021 Sep 7. doi: 10.1055/s-0041-1735492. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate the effect of different methods of delivery on the outcome of twin pregnancies.

METHODS: This is a retrospective cohort review of 627 twin pregnancies with delivery from January 2016 to December 2019. According to the clinical guidelines for cesarean section, the cesarean section and vaginal delivery groups were determined. Finally, the baseline information, delivery method, pregnancy outcome, and maternal and infant complications of the two groups were compared.

RESULTS: For different delivery methods, the incidence of preeclampsia was significantly higher in the cesarean section group than in the vaginal delivery group (χ² = 4.405, p < 0.05). There were 23 fetal growth ratios (FGR) in the cesarean section group, which were significantly higher than the vaginal delivery group (χ² = 4.740, p < 0.05). However, the incidence of preterm premature rupture of membranes (PPROM) in the vaginal delivery group was significantly higher than in the cesarean section group (χ² = 5.235, p < 0.05). In addition, the volume of postpartum bleeding in the vaginal delivery group was significantly higher than in the cesarean section group (t = 4.723, p < 0.001). The neonatal weights and 5-minute Apgar scores of the vaginal delivery group were lower than the cesarean section group, and the difference was statistically significant. In the vaginal delivery group, 48 and 26 neonates were transferred to the intensive care and neonatal units, respectively, which were significantly higher than in the cesarean section group (χ² = 5.001, p < 0.05).

CONCLUSION: The major complications of a twin pregnancy are gestational diabetes mellitus and PPROM. Cesarean section can reduce the rate of neonatal asphyxia in twins and improve the pregnancy outcome.

KEY POINTS: · Twin pregnancy. · Delivery methods. · Pregnancy outcomes.

PMID:34492720 | DOI:10.1055/s-0041-1735492

Blood Adv. 2021 Sep 7:bloodadvances.2021004568. doi: 10.1182/bloodadvances.2021004568. Online ahead of print.

ABSTRACT

Patient-reported outcomes (PROs) are relevant and valuable endpoints in the care of patients with myelodysplastic syndromes (MDS). However, a consensus-based selection of PROs for MDS, derived by both patients and hematologists, is lacking. We aimed to develop a core set of PROs for patients with MDS as part of the prospective European LeukemiaNet MDS (EUMDS) Registry. Following international guidelines, candidate PROs were identified from a comprehensive literature search in MDS studies. Overall, 40 PROs were selected and evaluated in a two-round Delphi survey by 40 patients with MDS and 38 hematologists in the first, and 38 and 32 in the second round, respectively. Based on an agreement scale and predefined inclusion criteria, both patients and hematologists selected “general quality of life” as a core PRO. Hematologists also selected “transfusion-dependency burden” and “ability to work/activities of daily living” as core PROs. The second Delphi round increased PRO rating agreements. Statistically significant rating differences between patients and hematologists were observed for 28 PROs (Mann-Whitney U test; p-value <0.05) in the first round and for 19 PROs in the second round, with “disease knowledge” and “confidence in health care services” rated notably higher by patients. The overall mean PRO ratings correlation between the two groups was moderate (Spearman’s rank correlation coefficient=0.5; p-value <0.05). This first consensus on a core set of PROs jointly developed by patients and hematologists forms the basis for patient-centered care in daily practice and clinical research.

PMID:34492684 | DOI:10.1182/bloodadvances.2021004568

Z Geburtshilfe Neonatol. 2021 Sep 7. doi: 10.1055/a-1585-3443. Online ahead of print.

ABSTRACT

INTRODUCTION: The “Delivery Expectancy Questionnaire” by Claas Wijma et al. (W-DEQ_A), which is the most frequently used internationally to determine high levels of fear of childbirth in pregnancy, was not previously available in German. In European countries, Canada, Australia and the United States, fear of childbirth is reported to have a prevalence of 6.3 to 14.8%. Particularly, women with a fear of childbirth have an increased risk for preeclampsia, intrauterine growth retardation, and caesarean sections.

METHODS: An English version of the W-DEQ_A authorized by Claas Wijma was translated and culturally adapted according to the guideline of Ohrbach et al. (INfORM). Content validity was statistically determined by means of the content validity index/average method (S-CVI/Ave).

RESULTS: The translation of all text sections of the W-DEQ_A was subjected to independent appraisal. One introductory question and three items needed to be retranslated. Moreover, three items required rewording to achieve cultural equivalence. The calculated content validity yielded an “excellent” S-CVI/Ave of 0.91.

CONCLUSION: The W-DEQ_A is now available in a German version for the self-assessment of fear of childbirth. It is entitled “Gedanken und Gefühle schwangerer Frauen im Hinblick auf die bevorstehende Geburt”. In the form of a digital health app, the questionnaire could be prescribed and the result directly transferred to the electronic patient record.

PMID:34492707 | DOI:10.1055/a-1585-3443

Ecotoxicol Environ Saf. 2021 Sep 3;225:112725. doi: 10.1016/j.ecoenv.2021.112725. Online ahead of print.

ABSTRACT

Despite the wide application of cobalt nanoparticles (CoNPs), its neurotoxicity and the underlying mechanisms are not fully understood. In this study, CoNPs-induced toxic effect was examined in both C57BL/6J mice and microglial BV2 cells. CoNPs-induced brain weight loss and the reduction of Nissl bodies, assuring neural damage. Moreover, both total unphosphorylated Tau and phosphorylated Tau (pTau; T231 and S262) expressions in the hippocampus and cortex were upregulated, unveiling Tau phosphorylation. Besides, the increase in inflammation-related proteins NLRP3 and IL-1β were found in mice brain. Corroborating that, microglial marker Iba-1 expression was also increased, suggesting microglia-involved inflammation. Among the NADPH oxidase (NOX) family proteins tested, only NOX2 was activated by CoNPs in hippocampus. Therefore, BV2 cells were employed to further investigate the role of NOX2. In BV2 cells, NOX2 expression was upregulated, corresponding to the production of ROS. Moreover, similar induction in Tau phosphorylation and inflammation-related protein expressions were observed in CoNPs-exposed BV2 cells. Treatment of apocynin, a NOX2 inhibitor, reduced ROS generation and reversed Tau phosphorylation and inflammation caused by CoNPs. Thus, CoNPs induced ROS production, Tau phosphorylation and inflammation specially via NOX2 activation.

PMID:34492628 | DOI:10.1016/j.ecoenv.2021.112725

Blood Adv. 2021 Sep 7:bloodadvances.2021004813. doi: 10.1182/bloodadvances.2021004813. Online ahead of print.

ABSTRACT

Post-remission strategies after dasatinib-corticosteroid induction in adults with Ph-positive acute lymphoblastic leukemia (ALL) are not well studied. We evaluated the feasibility and efficacy of dasatinib and dexamethasone induction then protocol-defined post-remission therapies, including hematopoietic cell transplantation (HCT). Adults (N=65) with Ph-positive ALL received dasatinib and dexamethasone induction, methotrexate-based central nervous system (CNS) prophylaxis, reduced-intensity conditioning (RIC) allogeneic HCT, autologous HCT, or chemotherapy alone based on age and donor availability, and dasatinib-based maintenance. Key efficacy endpoints were disease-free survival (DFS) and overall survival (OS). The median age was 60 years (range, 22-87). The complete remission rate was 98.5%. With a median follow up of 59 months, 5-year DFS and OS were 37% (median, 30 months) and 48% (median, 56 months), respectively. For patients receiving RIC allogeneic HCT, autologous HCT, or chemotherapy, 5-year DFSs were 49%, 29%, and 34% and 5-year OSs were 62%, 57%, and 46%, respectively. Complete molecular response rate after CNS prophylaxis was 40%. Relative to the p190 isoform, p210 had shorter DFS (median 10 vs 34 months, P=0.002) and OS (median 16 months vs not reached, P=0.05). Relapse occurred in 25% of allogeneic HCT, 57% of autologous HCT, and 36% of chemotherapy patients. T315I mutation was detected in 6 of 8 marrow relapses. Dasatinib CNS concentrations were low. Dasatinib and dexamethasone followed by RIC allogeneic HCT, autologous HCT, or chemotherapy was feasible and efficacious, especially with RIC allogeneic HCT. Future studies should address the major causes of treatment failure: T315I mutation, the p210 BCR-ABL1 isoform, and CNS relapse.

PMID:34492682 | DOI:10.1182/bloodadvances.2021004813