Category: Statistics

J Endourol. 2021 Feb 23. doi: 10.1089/end.2020.1059. Online ahead of print.

ABSTRACT

BACKGROUND: Suction during robotic surgery has traditionally been performed by a bedside assistant. Adequately-skilled assistants are not always available. We assessed a purpose-designed, robotic surgeon-controlled suction catheter for efficiency and safety by comparing with historic cases of suction controlled by a dedicated bedside assistant using standard rigid laparoscopic suction.

METHODS: Beginning in February 2019, the Remotely Operated Suction Irrigation (ROSI) device was used in all robotic prostatectomy (RP) procedures, which is a flexible suction catheter manipulated by the surgeon such that a bedside assistant is never required for suction. The initial 300 consecutive cases performed with ROSI were compared with the 300 immediately previous procedures using bedside-assistant suctioning.

RESULTS: There were no statistically-significant differences between groups in age, BMI, ASA score, PSA or pathological stage. Lymph node dissection was performed in all 600 patients. All 300 ROSI cases were completed without requiring switching to bedside-assistant suctioning. Estimated blood loss (102.7cc vs 120.2cc, p=0.001) and operative time (156.1min vs 149.3min, p<0.001) were slightly lower in the ROSI group. There was no statistical difference in the 90-day complication rate (Clavien ≥III) between groups, with both having 3% of patients readmitted or seen in the emergency department within 90 days of surgery.

CONCLUSION: Surgeon-controlled suction allowed more surgeon autonomy without a negative impact on efficiency or safety issues requiring “bailout” suctioning by the bedside assistant whether urgent or otherwise. Robotic surgeons without access to skilled bedside assistants should consider suctioning for themselves not unlike the norm for many laparoscopic surgeons.

PMID:33619992 | DOI:10.1089/end.2020.1059

J Am Heart Assoc. 2021 Feb 23:e019217. doi: 10.1161/JAHA.120.019217. Online ahead of print.

ABSTRACT

Background The current American College of Cardiology/American Heart Association women cardiovascular disease (CVD) risk score suboptimally estimates CVD risk for young and minority women in the military. The current study developed an internally validated CVD risk score for women military service members and veterans using the Veterans Affairs (VA) national electronic health records data. Methods and Results The study cohort included 69 574 White, Black, and Hispanic women service members and veterans aged 30 to 79 years in 2007 treated in the VA Health Care System between January 1, 2007 and December 31, 2017 (henceforth, VA women). Stratified by race and ethnicity, the new VA women CVD risk model estimated risk coefficients and 10-year CVD risk using a time-variant covariate Cox model. Harrell C-statistics, calibration plots, and net classification index were used to assess accuracy and prognostic performance of the new VA women CVD risk model. The new internally validated VA women CVD risk score performed better in predicting VA women 10-year atherosclerosis cardiovascular disease risk than the pooled cohort American College of Cardiology/American Heart Association risk score in both accuracy (White Harrell C-statistics, 70% versus 61%; Black, 68% versus 63%) and prognostic performance (White net classification index, 0.31; 95% CI, 0.26-0.33; Black net classification index, 0.06; 95% CI, 0.03-0.09). Conclusions The proposed VA women CVD risk score improves accuracy of the existing American College of Cardiology/American Heart Association CVD risk assessment tool in predicting long-term CVD risk for VA women, particularly in young and racial/ethnic minority women.

PMID:33619994 | DOI:10.1161/JAHA.120.019217

Clin Toxicol (Phila). 2021 Feb 23:1-8. doi: 10.1080/15563650.2021.1887493. Online ahead of print.

ABSTRACT

BACKGROUND: Recent recognition of “massive” acetaminophen (APAP) overdoses has led to the question of whether standard dosing of N-acetylcysteine (NAC) is adequate to prevent hepatoxicity in these patients. The primary aim of this study was to evaluate the clinical outcome for patients with massive APAP overdose who received standard intravenous NAC dosing of 300 mg/kg over 21 h.

METHODS: This was a single-center retrospective cohort study conducted by chart review of APAP overdoses reported to a regional poison center from 1 January 2010 to 31 December 2019. Massive APAP overdose was defined by single, acute overdose resulting in an APAP concentration exceeding 300 mcg/mL at 4 h post-ingestion. Standard univariate statistical analysis was conducted to describe the cohort, and a multivariate logistic model was utilized to calculate adjusted odds ratios for risk of hepatoxicity.

RESULTS: 1425 cases of APAP overdose were reviewed. 104 cases met the inclusion criteria of massive APAP overdose. Overall, 79 cases (76%) had no acute liver injury or hepatotoxicity, and 25 (24%) developed hepatoxicity. Nine percent (n = 4) of cases receiving NAC within 8 h developed hepatotoxicity. Crude odds for hepatoxicity was 5.5-fold higher for cases who received NAC after 8 h.

CONCLUSIONS: Standard NAC dosing received within 8 h prevented hepatoxicity in 91% (n = 40) of cases in our series of massive APAP overdoses. Additional data is needed to determine the clinical outcomes of massive APAP overdose using current intravenous NAC dosing.

PMID:33620007 | DOI:10.1080/15563650.2021.1887493

Scand J Urol. 2021 Feb 23:1-7. doi: 10.1080/21681805.2021.1889026. Online ahead of print.

ABSTRACT

INTRODUCTION AND AIM: Speedy diagnosis are mandatory in testicular torsion, nevertheless some cases of irreversible ischemia still occur. In this study we analysed the results of patients undergoing surgical exploration for acute scrotum.

MATERIALS AND METHODS: A multicentric retrospective clinical evaluation was carried out on patients who underwent urgent scrotal exploration at 12 different departments in North-Eastern Italy. Data included complete anagraphic information, clinical presentation, numeric pain rating scale, previous testicular surgery, Doppler serial ultrasonography (US) evaluation and concordance with surgical findings, testicular mobility, surgical treatment, staged or concurrent treatment of the contralateral gonad. Statistical analysis was conducted both for descriptive and inferential statistics with SPSS v26.

RESULTS: Three hundred and sixty-eight cases were collected between January 2010 and June 2019. The time between symptom onset and ER access time was within 6 h in majority of patients. However, 17.4% of subject presented after more than 12 h. In patients undergoing US, this showed signs of ischemia in 237 patients (77.2%) and normal vascularisation in 70 (22.8%) of whom 26 had signs of testicular torsion at surgical exploration. Overall, the US data were concordant with the surgical findings in 254 cases (82.7%). A significant association was found between time-to-evaluation and time-to-treatment and the need for orchiectomy (p < 0.01).

CONCLUSION: Testicular torsion management is still challenging in terms of time-saving decision making. Scrotal US is helpful, but even in the contemporary its sensitivity is low era in a non-neglectable number of cases, therefore surgical exploration is warranted in acute scrotum when torsion cannot be ruled out, even when US shows vascularisation.

PMID:33620015 | DOI:10.1080/21681805.2021.1889026

Proc Inst Mech Eng H. 2021 Feb 23:954411921994937. doi: 10.1177/0954411921994937. Online ahead of print.

ABSTRACT

The present study examined trends in occupant dynamics during side impact testing in vehicle models over the past decade. “Moderate-to-high” speed side impacts (delta-V ≥15 km/h) were analyzed. The Insurance Institute for Highway Safety (IIHS) side impact crash data was examined (N = 126). The test procedure involved a moving deformable barrier (MDB) impacting the sides of stationary vehicles at 50.0 km/h. Instrumented 5th-percentile female SID IIs dummies were positioned in the driver and left rear passenger seats. Occupant head, neck, shoulder, torso, spine, and pelvis/femur responses (times histories, peaks, and time-to-peak values) were evaluated and compared to injury assessment reference values (IARVs). The effects of delta-V, vehicle model year, vehicle body type, and occupant seating position on dynamic responses were examined. The vehicle lateral delta-Vs ranged from 15.9 to 34.5 km/h. The MY2018-2020 demonstrated lower peak dynamics than MY2010-2013, for the driver head acceleration (53.7 ± 11.3g vs 46.4 ± 11.6g), shoulder lateral forces (1.7 ± 0.7 kN vs 1.5 ± 0.2 kN), average rib deflection (29.8 ± 8.3 mm vs 28.4 ± 6.2 mm), spine accelerations at T4 (51.4 ± 23.4g vs 39.6 ± 5.9g) and T12 (56.3 ± 18.5g vs 45.2 ± 9.6g), iliac forces (1.9 ± 1.0 kN vs 1.2 ± 0.9 kN), and acetabular forces (1.9 ± 0.8 kN vs 1.3 ± 0.5 kN). The driver indicated statistically higher dynamic responses than the left rear passenger. Higher wheelbase vehicles generally showed lower occupant loading than the smaller vehicles. In conclusion, a reduction in occupant loading and risks for injury was observed in vehicle models over the past decade. This provides further insight into injury mechanisms, occupant dynamics simulations, and seat/restraint design.

PMID:33619979 | DOI:10.1177/0954411921994937

J Neurotrauma. 2021 Feb 23. doi: 10.1089/neu.2020.7407. Online ahead of print.

ABSTRACT

Neurological disorders usually present very heterogeneous recovery patterns. Nonetheless, accurate prediction of future clinical endpoints and robust definition of homogeneous cohorts are necessary for scientific investigation and targeted care. For this, unbiased recursive partitioning with conditional inference trees (URP-CTREE) has received increasing attention in medical research, especially, but not limited to traumatic spinal cord injuries (SCI). URP-CTREE was introduced to SCI as a clinical guidance tool to explore and define homogeneous outcome groups by clinical means, while providing high accuracy in predicting future clinical outcomes. The validity and predictive value of URP-CTREE to provide improvements compared to other more common approaches applied by clinicians has recently come under critical scrutiny. Therefore, a comprehensive simulation study based on traumatic, cervical complete spinal cord injuries provides a framework to investigate and quantify the issues raised. Firstly, we assessed the replicability and robustness of URP-CTREE to identify homogeneous subgroups. Secondly, we implemented a prediction performance comparison of URP-CTREE with traditional statistical techniques, such as linear or logistic regression, and a novel machine learning method. URP-CTREE’s ability to identify homogeneous subgroups proved to be replicable and robust. In terms of prediction, URP-CTREE yielded a high prognostic performance comparable to a machine learning algorithm. The simulation study provides strong evidence for the robustness of URP-CTREE, which is achieved without compromising prediction accuracy. The slightly lower prediction performance is offset by URP-CTREE’s straightforward interpretation and application in clinical settings based on simple, data-driven decision rules.

PMID:33619988 | DOI:10.1089/neu.2020.7407

J Am Heart Assoc. 2021 Feb 23:e018789. doi: 10.1161/JAHA.120.018789. Online ahead of print.

ABSTRACT

Background Presence of clonal hematopoiesis of indeterminate potential (CHIP) is associated with a higher risk of atherosclerotic cardiovascular disease, cancer, and mortality. The relationship between a healthy lifestyle and CHIP is unknown. Methods and Results This analysis included 8709 postmenopausal women (mean age, 66.5 years) enrolled in the WHI (Women’s Health Initiative), free of cancer or cardiovascular disease, with deep-coverage whole genome sequencing data available. Information on lifestyle factors (body mass index, smoking, physical activity, and diet quality) was obtained, and a healthy lifestyle score was created on the basis of healthy criteria met (0 point [least healthy] to 4 points [most healthy]). CHIP was derived on the basis of a prespecified list of leukemogenic driver mutations. The prevalence of CHIP was 8.6%. A higher healthy lifestyle score was not associated with CHIP (multivariable-adjusted odds ratio [OR] [95% CI], 0.99 [0.80-1.23] and 1.13 [0.93-1.37]) for the upper (3 or 4 points) and middle category (2 points), respectively, versus referent (0 or 1 point). Across score components, a normal and overweight body mass index compared with obese was significantly associated with a lower odds for CHIP (OR, 0.71 [95% CI, 0.57-0.88] and 0.83 [95% CI, 0.68-1.01], respectively; P-trend 0.0015). Having never smoked compared with being a current smoker tended to be associated with lower odds for CHIP. Conclusions A healthy lifestyle, based on a composite score, was not related to CHIP among postmenopausal women. However, across individual lifestyle factors, having a normal body mass index was strongly associated with a lower prevalence of CHIP. These findings support the idea that certain healthy lifestyle factors are associated with a lower frequency of CHIP.

PMID:33619969 | DOI:10.1161/JAHA.120.018789

J Am Heart Assoc. 2021 Feb 23:e018574. doi: 10.1161/JAHA.120.018574. Online ahead of print.

ABSTRACT

Background The female preponderance in heart failure with preserved ejection fraction (HFpEF) is a distinguishing feature of this disorder, but the association of sex with degree of diastolic dysfunction and clinical outcomes among individuals with HFpEF remains unclear. Methods and Results We conducted a prospective, multicenter, observational study of patients with HFpEF (PURSUIT-HFpEF [Prospective Multicenter Observational Study of Patients with Heart Failure with Preserved Ejection Fraction]: UMIN000021831). Between 2016 and 2019, 871 patients were enrolled from 26 hospitals (follow-up: 399±349 days). We investigated sex-related differences in diastolic dysfunction and postdischarge clinical outcomes in patients with HFpEF. The echocardiographic end point was diastolic dysfunction according to American Society of Echocardiography/European Association of Cardiovascular Imaging criteria. The clinical end point was a composite of all-cause death and heart failure readmission. Women accounted for 55.2% (481 patients) of the overall cohort. Compared with men, women were older and had lower prevalence rates of hypertension, coronary artery disease, and chronic kidney disease. Women had diastolic dysfunction more frequently than men (52.8% versus 32.0%, P<0.001). The incidence of the clinical end point did not differ between women and men (women 36.1/100 person-years versus men 30.5/100 person-years, P=0.336). Female sex was independently associated with the echocardiographic end point (adjusted odds ratio, 2.839; 95% CI, 1.884-4.278; P<0.001) and the clinical end point (adjusted hazard ratio, 1.538; 95% CI, 1.143-2.070; P=0.004). Conclusions Female sex was independently associated with the presence of diastolic dysfunction and worse clinical outcomes in a cohort of elderly patients with HFpEF. Our results suggest that a sex-specific approach is key to investigating the pathophysiology of HFpEF. Registration URL: https://upload.umin.ac.jp; Unique identifier: UMIN000021831.

PMID:33619973 | DOI:10.1161/JAHA.120.018574

Med Glas (Zenica). 2021 Feb 1;18(1). doi: 10.17392/1282-21. Online ahead of print.

ABSTRACT

Aim To evaluate if the sinus tarsi approach treated with open reduction and internal fixation (ORIF), without using plate fixation, provided good functional results in active adult population. The hypothesis was that the sinus tarsi approach with limited incision provided good results comparable to other approaches. Methods A total of 78 patients (81 feet) surgically treated for articular calcaneus fracture were reviewed according to inclusion criteria: Sanders fracture type II-III, minimum follow-up of 2 years, patients aged 18-65 years. Exclusion criteria were smokers, diabetics, non-collaborative patients and patients with Sanders fracture type I and IV. A mean follow-up was 52.6 months. Radiographic changes of the Bohler’s angle were reported. For the clinical evaluation, Visual Analogue Scale (VAS) for calcaneal fractures, American Orthopaedic Foot and Ankle Society (AOFAS) score and Maryland Foot Score (MFS) were used. Results A statistically significant restitution of Böhler’s angle from preoperative to postoperative (13.5°-27°; p<.001) was found. The AOFAS and MFS showed pain relief and good/excellent functional activities at the final follow-up in 65 of 78 (83.3%) patients. In eight (out of 81; 10%) feet a superficial wound infection was observed. In three (3.8%) patients a subtalar arthrodesis was performed. Conclusion The mini-invasive sinus tarsi approach for active adult population is a valid and reproducible technique with a low rate of major complications, but it is mandatory advice to patients regarding the expectation of the results.

PMID:33619940 | DOI:10.17392/1282-21

Eur J Phys Rehabil Med. 2021 Feb 23. doi: 10.23736/S1973-9087.21.06566-7. Online ahead of print.

ABSTRACT

BACKGROUND: Children with cerebral palsy (CP) often present a loss of effectiveness of the plantarflexors/knee-extensors couple that leads to crouch gait. When treating a child with crouch gait by means of ankle foot orthoses, preserving or restoring push off power is a key issue.

AIM: To compare carbon-fiber spring (Carbon Ankle Seven® = CAFO) and hinged anklefoot orthoses (HAFO) effectiveness in improving functionality and walking ability in children with diplegic CP and crouch gait.

DESIGN: Randomized crossover trial.

SETTING: Hospital center.

POPULATION: Ten children with diplegic CP and crouch gait, 5 males and 5 females, aged 11 (4) years.

METHODS: The gait of each child was evaluated by means of instrumental gait analysis with both CAFO and HAFO, in a randomized order and after a 4-week adaptation period. The primary outcome measure was the change in ankle power generation. As secondary outcome measures, knee joint kinematics, stride length, walking speed, Observational Gait Scale, and preferred orthosis were considered.

RESULTS: The median of the energy produced in stance was superior with CAFO (+2.2 J/kg, IQR 4.7, p=0.006), and the energy absorbed inferior (-3.3 J/kg, IQR 4.3, p=0.011). No statistically significant difference was found for any other parameter. Preference of the children was equally distributed between the two orthoses.

CONCLUSIONS: No evident superiority of CAFO with respect to HAFO was found in improving gait performance of children with CP and crouch gait. Nevertheless, the results suggest the possibility that CAFO permits an energy saving and reduction of the more compromising deficits.

CLINICAL REHABILITATION IMPACT: The final choice of the participants indicates that CAFOs are preferred by older and heavier children, but the preference does not correlate with the performance of the orthoses during gait.

PMID:33619943 | DOI:10.23736/S1973-9087.21.06566-7