Validity and internal consistency of the American Orthopaedic Foot and Ankle Society Midfoot Scale in patients with Lisfranc injury

BackgroundThe American Orthopaedic Foot and Ankle Society (AOFAS) Midfoot Scale is an extensively used outcome measure instrument for evaluating outcomes after foot and ankle surgery or trauma.MethodsIn total, 117 patients with Lisfranc injury completed the AOFAS Midfoot Scale and the Visual Analogue Scale Foot and Ankle (VAS-FA) instruments. Internal consistency (correlation between different items), floor and ceiling values, convergent validity, item threshold distribution, and the coverage (item difficulty) of the AOFAS Midfoot scale were tested.ResultsAOFAS Midfoot Scale had high convergent validity and acceptable internal consistency (Cronbach’s alpha >0.70). The ceiling effect was confirmed. The person-item distribution indicated that the scale had a lack of coverage and targeting in our sample.ConclusionsOur data suggests that the AOFAS Midfoot Scale has acceptable validity and internal consistency. However, due to the lack of coverage and targeting, it should not be the primary outcome measure to be used to evaluate the outcomes after Lisfranc injury in the future studies.     

Validating the Foot and Ankle Outcome score for measuring foot dysfunction among hallux valgus surgery patients using item response theory

BackgroundThere is an absence of high quality research validating instruments that measure foot and ankle related quality of life among hallux valgus (bunion) patients’ perspectives. The Foot and Ankle Outcome Scale is a patient-reported outcome instrument, that when administered to patients with symptomatic hallux valgus, provides a patient-centric perspective of their foot function. The aim of this study is to assess the psychometric properties of the instrument’s five subscales among preoperative bunion surgery patients.MethodsThe Foot and Ankle Outcome Scale instrument measures Pain, Symptoms, Activities of Daily Living, Sport and Recreational Activities and Foot/Ankle Related Quality of Life. Preoperative data is collected from a sample of patients scheduled for surgical treatment of their condition in Vancouver, Canada. Classical and item response theory methods are used to report on reliability, validity and differential item functioning among subgroups.ResultsThis study included 249 surveys, representing an overall response rate of 44.1% among 564 eligible patients. The instrument demonstrated high reliability for all subscales, though 18 items across subscales, exhibited poor discrimination between item levels. Four items score differently according to patients’ sex and one item scored differently by age.ConclusionsThe instrument measures five domains of health important to bunion patients. These findings suggest that the current instrument can be used with an understanding of its limitations, including redundant questions and sex-based differences. Future research should revise a number of items. The results highlight the importance of the psychometric analyses of instruments in specific patient populations.     

Comparison of midterm results of endovascular aneurysm repair for ruptured and elective abdominal aortic aneurysms

ObjectiveEndovascular aneurysm repair (EVAR) became an increasingly preferred modality for abdominal aortic aneurysm (AAA) repair both in elective AAA repair (el-EVAR) and EVAR of a ruptured AAA (r-EVAR) setting. Ruptured AAAs usually have more hostile anatomies and less time for planning. Consequently, more complications may arise after r-EVAR. The purpose of this study was to compare mi-term outcomes between r-EVAR and el-EVAR.MethodsA retrospective cohort analysis of patients undergoing EVAR from 2000 to 2015 at a tertiary institution was performed. Patients with previous aortic surgery, nonatherosclerotic AAA and isolated iliac aneurysms were excluded. In-hospital casualties or patients who were intraoperatively converted to open repair were also excluded. For the midterm outcome analysis, only patients with at least two postoperative examinations (a 30-day computed tomography scan and a second postoperative examination performed 6 months or later) were considered. The primary end point was freedom from aneurysm-related complications (a composite of type I or III endoleak, aneurysm sac growth, migration of more than 5 mm, device integrity failure, AAA-related death, late postimplant rupture, or AAA-related secondary intervention). Freedom from secondary interventions, neck-related events (defined as a composite of type IA endoleak, migration of more than 5 mm, or preemptive neck-related secondary intervention) and late survival were secondary end points. The impact of device instructions for use (IFU) compliance on neck events was also assessed.ResultsThe study included 565 patients (65 r-EVAR and 500 el-EVAR). Eighty-two patients were treated outside proximal neck IFU, 13 in the r-EVAR group (21.3%) and 69 (14.5%) in the el-EVAR (P = .16). During the index hospitalization, there were more complications (12.3% vs 3.2%; P = .001) and reinterventions (12.3% vs 2.8%; P < .001) in the r-EVAR group. After discharge, median clinical follow-up time was 4.3 years (interquartile range, 2.1-7.0 years) without differences between both groups. Five-year freedom from AAA-related complications was 53.9% in the r-EVAR group and 65.4% in the el-EVAR (P = .21). In multivariable analysis the r-EVAR group was not at increased risk for late complications (hazard ratio [HR], 0.94; 95% confidence interval [CI], 0.54-1.61; P = .81). Five-year freedom from neck-related events was 74% in r-EVAR and 82% in the el-EVAR group (P = .345). Patients treated outside neck IFU were at greater risk for neck-related events both in r-EVAR (HR, 6.5; 95% CI, 1.8-22.9; P = .004) and el-EVAR group (HR, 2.6; 95% CI, 1.5-4.5; P < .001). Freedom from secondary interventions at 5 years was 63.0% for r-EVAR and 76.9% for el-EVAR (P = .16). Survival at 5 years was 68.8% in the r-EVAR group and 73.3% in the el-EVAR group (P = .30).ConclusionsDurable and sustainable midterm outcomes were found for both r-EVAR and el-EVAR patients who survived the postoperative period. Patients treated outside the IFU are at greater risk for late complications. Surveillance protocols may be tailored according to individual anatomy and IFU compliance rather than timing of repair.     

Sunitinib versus pazopanib para el tratamiento del carcinoma de células renales metastásico: experiencia en 2 hospitales turcos

IntroductionSunitinib (SUN) and pazopanib (PAZ) are 2 oral tyrosine kinase inhibitors against vascular endothelial growth factor. Their efficacy and safety in metastatic renal cell carcinoma has been proven with phase iii studies. However, real world data is limited. The objective of this study is to assess the clinical benefit of SUN and PAZ in routine practice.MethodsWe reviewed the medical records of 79 metastatic renal cell carcinoma patients treated with SUN (50 mg/day on 4/2-schedule) or PAZ (800 mg/day continuously). Patients were assessed retrospectively at 2 Turkish hospitals between 2006 and 2016.ResultsFor the entire cohort median age of patients was 60 (28-87) years and 70% of them were male. The objective response rate and disease control rate in SUN/PAZ groups were 34/37% (P = .96) and 78/87% (P = .046), respectively. With a median follow up duration of 15 months, median progression-free survival and overall survival in SUN/PAZ groups were 8/8 months (P = .83) and 22/21 months (P = .53), respectively. The common all grade toxicities for SUN vs. PAZ were fatigue (59 vs. 74%), skin changes (44 vs. 44%), anemia (35 vs. 42%), hypothyroidism (37 vs. 19%; P = .02) and hypertension (33 vs. 50%). In patients treated with SUN, total grade 3-4 toxicities (mean number of toxic events per patients) were 0.71, whereas in patients treated with PAZ, total grade 3-4 toxicities were 0.11 (P < .001). SUN was associated with an increased incidence of grade 3-4 fatigue (P = .007), anemia (P = .001) and hypothyroidism that needed therapy (P = .02). Dose reduction in 49 and 24% of patients (P = .02), and treatment cessation in 37 and 26% of patients (P = .37) were required in the SUN and PAZ groups, respectively.ConclusionsIn our study, there was no difference in terms of survival outcomes between 2 agents. However, patients treated with SUN had more grade 3-4 adverse events which prompted dose reduction.     

External validation of the post-varicocele repair semen analysis nomogram to predict total motile sperm count: A multicenter study

Total motile sperm count is an important parameter for predicting the probability of natural pregnancy. We have externally validated the Samplaski's post-varicocele repair semen analysis nomogram to confirm the predictive accuracy of total motile sperm count. A total of 300 patients who had undergone varicocelectomy between July 2016 and July 2019 from 4 treatment centres were included in this validation cohort study. The predictive performance of the externally validated nomogram was revealed by applying the Pearson correlation coefficient (R = 0.328; 95% confidence interval (CI) 0.220–0.435; p < .001). Compared to Samplaski's nomogram result (R = 0.581; 95% CI 0.186–0.729), our study also revealed a statistically significant rate. However, it had a relatively lower correlation coefficient rate. Notably, the predicted total motile sperm count was lower than the observed post-varicocelectomy total motile sperm count. The calibration plot revealed that the discrepancy between the predicted and observed total motile sperm count was plausible. However, it had low explanatory power in this nomogram model. This validation study demonstrates that the post-varicocele repair Samplaski's nomogram predicts a relatively lower total motile sperm count than the observed count.     

Pregnancy and burns: Guidelines for safe management

BackgroundIThe incidence of burns in pregnancy is very low, therefore little is confirmed in the specific management of pregnant women who are burned.PurposeWe conducted a study to survey the frequency of pregnancy in our patients and evaluate the risk factors of mortality for mother and foetus. Finally we provide recommendations about management of mother and child.Materials and methodsRetrospectively, we surveyed data of our pregnant patients for an 18 year period. All demographic data, gestational age, history of previous pregnancy or miscarriage, diabetes, suicide, number of operations, presence of inhalation injury, TBSA, percentage of burn in abdomen and lower extremity, early excision and outcome of mother and foetus were gathered in a special questionnaire. Uni-variate regression and multi-variate regression were done for mortality of mother and child.ResultsWe treated 89 pregnant patients. Mean (SD) of mother's age and their pregnancy age were 24.08 ± 5.56 years and 19.18 ± 9.24 weeks, respectively. Mean TBSA (SD) was 36 (18%). Median of TBSA was 38 (IQR: 25, 70). Median of TBSA in Abdomen was 8 (IQR: 7, 9). Median of TBSA in lower extremities was 18 (IQR: 9, 34). Nine cases were due to attempted suicide. For 34 patients skin grafting was done. The main cause of death of the mothers was sepsis. The infections were due to Pseudomonas aeruginosa, Acinetobacter, E. coli, Klebsiella and Staphylococcus. In uni-variate regression model, TBSA, gestational week, and burns involving the abdomenwere related to maternal mortality. In multi-variate regression model, TBSA had high influence on maternal mortality, with every percent of burn surface area, the risk of mortality increased by 3.4% (p-value <0.005). In a uni-variate regression, TBSA and abdominal burn was associated with foetal mortality. However, in the multi-variate regression, only inhalation injury and TBSA had association with foetal mortality. Inhalation injury increased foetal mortality up to 16 times (p-value <0.05).ConclusionTBSA burned is the only major risk factor of maternal mortality. TBSA burned and inhalation injury are the main risk factors of foetal mortality.     

基于基因型检测的药学干预对住院患者应用华法林疗效和安全性的影响

目的：探讨基于基因型检测的药学干预对住院患者应用华法林疗效和安全性的影响。方法收集2013年6月至2014年3月在北京大学第一医院住院并根据细胞色素P450（CYP）2C9＊2、CYP2C9＊3、维生素K环氧化物还原酶复合物1（VKORC1）G-1639A基因型检测结果调整华法林剂量患者（试验组）和2012年6至12月应用华法林但未进行基因型检测患者（对照组）的病历资料进行回顾性分析,比较2组患者的住院时间、服用华法林时间、国际标准化比值（ INR）曾出现≥3.0者占比、华法林相关出血发生率、出院时INR和出院时华法林剂量,对试验组患者分析出院时华法林剂量与临床药师给予的华法林建议剂量的相关性,并分析试验组患者上述指标与基因型的相关性。结果试验组102例,男性62例,女性40例,年龄14-88岁,平均（63±16）岁。对照组140例,男性89例,女性51例,年龄21-85岁,平均（64±13）岁。原发疾病包括心房颤动、深静脉血栓、肺栓塞和肾静脉血栓等。2组患者年龄和性别分布差异均无统计学意义。试验组平均住院时间和服用华法林时间明显长于对照组[（16.7±8.4）d比（12.6±6.0）d,（13.2±8.2）d比（9.9±6.1）d,均P＆lt;0.001]。2组中INR≥3.0者占比、华法林相关出血发生率、出院时INR的差异均无统计学意义。试验组携带CYP2C9＊1/＊3者（7例）出院时华法林剂量低于携带CYP2C9＊1/＊1者（95例）[（1.79±0.57）mg/d比（3.12±1.13）mg/d,P=0.003];携带VKORC1-1639 GG者（1例）和VKORC1-1639GA者（20例）出院时华法林剂量均高于携带VKORC1-1639AA者（81例）[6.00、（3.55±1.63）mg/d 比（2.87±0.92） mg/d,P=0.002]。试验组INR≥3.0者住院时间和服用华法林时间均多于INR＆lt;3.0者[（24.7±10.9）d比（15.2±6.9）d,（21.8±10.9）d比（11.6±6.4）d,均P＆lt;0.001],出院时华法林剂量低于INR＆lt;3.0者[（2.50±1.02）mg/