Tag: statistics

Braz J Phys Ther. 2021 Nov 12:S1413-3555(21)00098-8. doi: 10.1016/j.bjpt.2021.10.003. Online ahead of print.

ABSTRACT

BACKGROUND: This statistical analysis plan details the Coaching for Healthy AGEing (CHAnGE) trial analysis methodology.

OBJECTIVE: To investigate the effect of a combined physical activity and fall prevention program on physical activity and falls compared to a healthy eating among people aged 60 years and over.

METHODS: The CHAnGE trial is a pragmatic parallel-group cluster-randomised controlled trial with allocation concealment and blinded assessors. Clusters are allocated to either (1) a physical activity and fall prevention intervention or (2) to a healthy eating intervention. The primary outcomes are: objectively measured physical activity at 12 months post-randomisation, and self-reported falls throughout the 12-month trial period. Secondary outcomes include the proportion of participants reporting a fall, the proportion of participants meeting the Australian physical activity guidelines, body mass index, eating habits, mobility goal attainment, mobility-related confidence, quality of life, fear of falling, risk-taking behaviour, mood, well-being, self-reported physical activity, disability, and use of health and community services.

ANALYSIS: We will follow the intention-to-treat principle. All analysis will allow for cluster randomisation using a generalised estimating equation approach. The between-group difference in the number of falls per person-year will be analysed using negative binomial regression models. For the continuously scored primary and secondary outcome measures, linear regression models adjusted for corresponding baseline scores will assess the effect of group allocation. Analyses will take into account cluster randomisation and will be adjusted for baseline scores. A subgroup analysis will assess differential effects of the intervention by baseline physical activity levels and history of falls.

PMID:34802917 | DOI:10.1016/j.bjpt.2021.10.003

J Perianesth Nurs. 2021 Nov 18:S1089-9472(21)00286-0. doi: 10.1016/j.jopan.2021.07.007. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of this quality improvement project was to improve care of obstructive sleep apnea (OSA) patients through increased staff recognition of OSA in the postanesthesia care unit (PACU).

DESIGN: Retrospective chart review with implementation of best practice guideline form to front of patient’s chart.

METHODS: Baseline data were collected during June 2020. Staff education was provided on current hospital policy of OSA patients. Implementation of a care guideline sheet was added to the front of patient charts for patients meeting inclusion criteria; it consisted of continuous pulse oximetry, 30-degree head of bed elevation, continuous positive airway pressure (CPAP) therapy, 1 hour minimum postoperative observation, nonopioid analgesics, and referral to polysomnography. A retrospective chart review was performed following the OSA guideline intervention.

FINDINGS: Both pre- (N = 413) and postintervention (N = 420) groups had statistically similar demographics. CPAP use increased from 16 to 22 (t = 0.890; P = .336). The number of patients experiencing dyspnea decreased from 10 to 8 (t = 0.263; P = .608). The number of patients experiencing acute respiratory events (AREs) decreased from 24 to 18 (t = 1.012; P = .314).

CONCLUSION: There were no significant statistical findings. However, increased recognition of OSA patients by PACU staff can lead to improved care alterations.

PMID:34802923 | DOI:10.1016/j.jopan.2021.07.007

Acad Radiol. 2021 Nov 19:S1076-6332(21)00469-4. doi: 10.1016/j.acra.2021.10.009. Online ahead of print.

ABSTRACT

RATIONALE AND OBJECTIVES: First, to evaluate and compare three different diffusion sequences (i.e., standard DWI, IVIM, and DKI) for nodal staging. Second, to combine the DWI, and anatomic information to assess metastatic lymph node (LN).

MATERIALS AND METHODS: We retrospectively identified 136 patients of rectal adenocarcinoma who met the inclusion criteria. Three diffusion sequences (i.e., standard DWI, IVIM, and DKI) were performed, and quantitative parameters were evaluated. Univariate and multivariate analyses were used to assess the associations between the anatomic and DWI information and LN pathology. Multivariate logistic regression was used to identify independent risk factors. A nomogram model was established, and the model performance was evaluated by the concordance index (c-index) and calibration curve.

RESULTS: There was a statistical difference in variables (LN long diameter, LN short diameter, LN boundary, LN signal, peri-LN signal intensity, ADC_-1000, ADC_-1400, ADC_-2000, K_app and D) between metastatic and non-metastatic LN for training and validation cohorts (p < 0.05). The ADC value derived from b = 1000 mm/s (ADC_-1000) showed the relative higher AUC (AUC = 0.780) than the ADC value derived from b = 1400 mm/s (ADC_-1400) (AUC = 0.703). The predictive accuracy of the nomogram measured by the c-index was 0.854 and 0.812 in the training and validation cohort, respectively.

CONCLUSION: The IVIM and DKI model’s diagnostic efficiency was not significantly improved compared to conventional DWI. The diagnostic accuracy of metastatic LN can be enhanced using the nomogram model, leading to a rational therapeutic choice.

PMID:34802905 | DOI:10.1016/j.acra.2021.10.009

J Foot Ankle Surg. 2021 Oct 22:S1067-2516(21)00393-8. doi: 10.1053/j.jfas.2021.10.009. Online ahead of print.

ABSTRACT

Given that most ankle replacements are post-traumatic in origin, it is important to investigate if prior interventions affect a patient’s functional outcomes or increase the possibility of complications. Prior ankle surgeries create scar tissue and zones of impaired vascularity which could ultimately interfere with surgical healing. The purpose of this study is to assess the pain and functional temporal outcomes of patients with and without prior surgeries in the ipsilateral ankle. We retrospectively identified a consecutive series of 100 primary total ankle replacements (TARs) who were followed for a minimum of 3 years, with follow-up time points of 0, 6, 12, and 36 months. We documented prior surgical interventions and several patient-reported outcomes. Outcomes were measured using American Orthopaedic Foot and Ankle Society (AOFAS) score, Visual Analogue Scale (VAS), 12-Item Short Form Study (SF-12), and range of motion scores. The 2 groups showed no difference on the temporal evolution of outcomes. An irrigation and debridement of previous open fractures was the only presurgical intervention that showed a statistically significant difference in temporal evolution of functional and pain outcomes between intervention and nonintervention groups. No significant correlations were found between all outcomes and the time between the last intervention and ankle replacement surgery. A preoperative discussion should center on potential complications and predicted functional outcomes. The presence, type, and timing of an intervention prior to an ankle replacement do not strongly affect the temporal outcomes of pain and functional outcome scores. Furthermore, the complication rate is not affected by prior surgeries.

PMID:34802908 | DOI:10.1053/j.jfas.2021.10.009

J Craniomaxillofac Surg. 2021 Nov 15:S1010-5182(21)00243-2. doi: 10.1016/j.jcms.2021.11.006. Online ahead of print.

ABSTRACT

The study aims to assess the influence on mortality of motorcycle road accidents, caused by injuries to the head, chest, abdomen, face, skin, pelvis and extremities. Road motorcycle accidents consecutively admitted to Level I Trauma Center were retrospectively analyzed. Each body site involvement was classified through Abbreviated Injury Score (AIS-98), and Comprehensive Facial Injury (CFI) score; Injury Severity Score (ISS) was also calculated. The data collected were subjected to a descriptive analysis and inferential statistic, with uni- and multivariate analysis; mortality was the main outcome examined. 1862 patients were studied. Limbs (53.9%) and Head (53.8%) are the most involved body site, facial trauma regards 19.4% of the sample. Only 4.4% of Facial injuries occurred as isolated, 71.6% were associated to Head involvement. The overall mortality was 4.6% and 80.0% of dead patients were affected by Head injury. Multivariate analysis shows that head (OR=3.06, p <0.0001), thoracic (OR=1.82, p <0.0001) and abdominal trauma (OR=1.41, p =0.019) are predicting the risk of death. Facial trauma does not directly influence mortality and, however severe and distracting it may be, becomes secondary to the management of frequently associated brain injuries. Severity scores targeted to the risk of death, such as AIS and AIS-derived, are ineffective in describing the true characteristics of facial injuries. The CFI score has been shown to predict the weight of surgical treatment and the outcome of the hospital stay, therefore its use is recommended.

PMID:34802885 | DOI:10.1016/j.jcms.2021.11.006

J Craniomaxillofac Surg. 2021 Nov 14:S1010-5182(21)00246-8. doi: 10.1016/j.jcms.2021.11.009. Online ahead of print.

ABSTRACT

The aim of this study was to evaluate the nasolabial soft tissues effects in three different Le Fort I osteotomy techniques using cone beam computed tomography (CBCT) evaluation of three-dimensional (3D) volume surfaces. A retrospective study was designed, and three groups were evaluated: group 1, patients who underwent conventional Le Fort I osteotomy; group 2, patients who underwent subspinal Le Fort I osteotomy; and group 3, patients who underwent conventional Le Fort I osteotomy with ANS recontouring or removal. CBCT evaluation was performed at two time points: T0, 1 week before surgery; T1, 6 months after surgery. A total of 90 patients were enrolled in this study (group 1: 30; group 2: 30; group 3: 30). Mean maxillary advancement was 4.26 mm. For group 1, mean change in inter-alar width was 2.29 ± 1.57 mm (minimum -2mm; maximum 6.1 mm; for group 2 it was 1.20 ± 1.56 mm (minimum -1.7 mm; maximum 5.9 mm), and for group 3 was 1.84 ± 1.76 mm (minimum -2.3 mm; maximum 5.9 mm). For group 1, mean change in alar base width was 1.69 ± 2.32 mm (minimum -4.8 mm; maximum 6,1 mm); in group 2 it was 0.85 ± 2.08 mm (minimum -4mm; maximum 6 mm), and group 3 was 1.21 ± 1.83 mm (minimum -2mm; maximum 5 mm). Results showed statistically significant differences in nasolabial area (P < 0.001). Within the limitations of the study it seems that subspinal Le Fort I osteotomy should be preferred when the priority is to avoid changes to the nasolabial region.

PMID:34802886 | DOI:10.1016/j.jcms.2021.11.009

Curr Probl Diagn Radiol. 2021 Nov 3:S0363-0188(21)00166-3. doi: 10.1067/j.cpradiol.2021.09.004. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: Rhino-orbital-cerebral mucormycosis has emerged as a major opportunistic infection in patients with COVID-19. High clinical suspicion and prompt imaging are crucial for early diagnosis and management. Our study evaluates imaging characteristics of patients with COVID-19 associated Rhino-orbital-cerebral Mucormycosis (CA-ROCM) in a tertiary care hospital in India.

MATERIALS AND METHODS: A retrospective analysis of clinical and imaging data of patients with CA-ROCM who presented between December 2020 to June 2021 was performed. All patients had microbiologically or histologically proven sino-nasal mucormycosis along with documented SARS-CoV-2 positive RT-PCR test and/or classical lung imaging features of COVID-19 infection. The extent of sinus involvement, bony erosions, extra-sinus soft tissue extension, orbital-intracranial invasion, perineural spread, and vascular complications were assessed.

RESULTS: Fifty patients were included for the final analysis. Diabetes was the most common associated comorbidity. Seven patients presented with stage I disease, 18 patients with stage II, and 25 patients with stage III disease. The stage of disease showed a positive statistical correlation with HbA1c levels using Pearson’s correlation. The common imaging features were “Black turbinate sign” and nonenhancing sino-nasal mucosa (82%), orbital involvement (76%), and diffusion restriction in the optic nerve (24%). Intracranial involvement was seen as perineural extension into the brain (42%), cerebritis (30%), and internal carotid artery involvement (16%).

CONCLUSIONS: CA-ROCM is an acute invasive fungal sinusitis with an aggressive clinical course. Black-turbinate sign and peri-antral soft tissue infiltration are early features, whereas extra-nasal tissue infarction, optic nerve diffusion restriction, and vascular invasion are seen with advanced disease.

PMID:34802841 | DOI:10.1067/j.cpradiol.2021.09.004

Vaccine. 2021 Nov 18:S0264-410X(21)01474-2. doi: 10.1016/j.vaccine.2021.11.029. Online ahead of print.

ABSTRACT

BACKGROUND: Patients with advanced chronic kidney disease should be vaccinated against hepatitis B. In observational studies vitamin D insufficiency is associated with a reduced seroconversion rate. The effect of cholecalciferol supplementation on hepatitis B vaccination response in haemodialysis patients with vitamin D insufficiency is unknown.

METHODS: In this randomized open label pilot study 40 unvaccinated haemodialysis patients with 25(OH)D insufficiency (<30 ng/mL) were enrolled. In the supplementation group, we administered cholecalciferol orally in a dose of 28,000 IU weekly for a maximum of 12 weeks. Hepatitis B vaccination (HBvaxPRO 40 µg i.m. months 0, 1, 6) was performed after achieving a 25(OH)D level >30 ng/mL or after completing three months of supplementation despite failure to achieve the target level. In the control group, patients were vaccinated immediately after randomization. Anti-hepatitis B-antibody titer (anti-HBs) was measured eight weeks after completing the vaccination course.

RESULTS: Thirty-seven (26 male, 11 female) patients aged 65 (13.5) years underwent randomization with 17 patients allocated to the control group and 20 patients included in the supplementation group. After 12 weeks of cholecalciferol supplementation, mean (SD) 25(OH)D concentration increased from 15.0 (8.0) to 31.0 (7.1) ng/mL, but remained unchanged in the control group (14.0 (7.1) to 11.6 (7.5) mg/mL). Neither the number of patients with seroconversion (anti-HBs titer ≥ 10 IU/L; n = 6 (35.3%) vs n = 3 (27.3%), p = 0.704), nor the number of patients with seroprotection (anti-HBs titer >100 IU/L; n = 4 (23.5%) vs n = 2 (18.2%) differed between treatment groups. Cholecalciferol supplementation was safe without treatment-related adverse events.

CONCLUSION: In this small pilot study, high-dose oral cholecalciferol supplementation did not improve the hepatitis B vaccination response in haemodialysis patients with vitamin D insufficiency. This clinical trial was registered within EudraCT (EudraCT number 2011-004621-26).

PMID:34802788 | DOI:10.1016/j.vaccine.2021.11.029

J Hand Surg Am. 2021 Nov 18:S0363-5023(21)00618-3. doi: 10.1016/j.jhsa.2021.09.023. Online ahead of print.

ABSTRACT

PURPOSE: We evaluated the impact of angled derotational Kirschner wires (K-wires) on fracture gap reduction with variable-pitch headless screws.

METHODS: Fully threaded variable-pitch headless screws (20 and 28 mm) were inserted into “normal” bone models of polyurethane blocks. In separate trials, derotational K-wires were inserted at predetermined angles of 0°, 15°, 30°, and 40° and compared with each other, with no K-wire as a control. Fluoroscopic images taken after each screw turn were analyzed. The optimal fracture gap closure, initial screw push-off, and screw back-out gap creation were determined and compared at various derotational K-wire angles.

RESULTS: Initial screw push-off due to screw insertion and screw back-out gap creation were not significantly affected by the angle of the derotational K-wire. With a 20-mm screw, only a 40° derotational K-wire led to significantly less gap closure compared with control and with 0°, 15°, and 30° derotational K-wires. It led to an approximately 60% decrease in gap closure compared with no K-wire. With the 28-mm screw, compared with no K-wire, 15° and 30° derotational K-wires led to statistically significant decreases in gap closure (approximately 25%), whereas a 40° derotational K-wire led to an approximately 60% decrease. With the 28-mm screw, the 40° derotational K-wire also led to a statistically significant smaller gap closure when compared with 0°, 15°, and 30° derotational K-wires.

CONCLUSIONS: A derotational K-wire placed in parallel to the planned trajectory of a headless compression screw does not affect fracture gap closure. With greater angulation of the derotational K-wire, the fracture gap is still closed, but less tightly.

CLINICAL RELEVANCE: Derotational K-wires can help prevent fracture fragment rotation during headless compression screw insertion. At small deviations from parallel (≤30°), fracture gap closure achieved by the screw is minimally affected. At greater angles (ie, 40°), fracture gap closure may be substantially reduced, preventing fracture compression.

PMID:34802813 | DOI:10.1016/j.jhsa.2021.09.023

Auris Nasus Larynx. 2021 Nov 18:S0385-8146(21)00253-4. doi: 10.1016/j.anl.2021.10.010. Online ahead of print.

ABSTRACT

OBJECTIVE: To analyze the preoperative patterns of caloric test, eye tracking test (ETT), and optokinetic pattern (OKP) in patients with acoustic neuroma (AN) and compare them with the postoperative patterns of ETT and OKP results METHODS: A total of 166 patients with AN (102 women; mean age: 41 years, range: 11-79 years) who were being treated at our hospital between 2013 and 2016 were enrolled. Preoperatively, a detailed history was taken regarding the presence of subjective symptoms of equilibrium dysfunction, and the patients underwent caloric test, ETT, and OKP. They were classified into three groups based on the preoperative ETT and OKP results as follows: Group A, normal ETT and OKP; Group B, either ETT or OKP was abnormal; and Group C, both ETT and OKP were abnormal. All patients were evaluated for subjective symptoms of vestibular dysfunction and were also grouped based on the tumor size on imaging. All surgeries were performed by a neurosurgeon using the lateral suboccipital retrosigmoid approach. About one month later after surgery, postoperatively ETT was performed on 150 patients and OKP was performed on 148 patients. The preoperative and postoperative ETT and OKP results were compared. The same two specialists analyzed the postoperative ETT and OKP findings as improved, unchanged, or worse. Student t-test was used for statistical analysis and a P-value of <0.05 was considered to indicate a statistically significant difference.

RESULTS: The average canal paresis(CP) % was 65.8%. No correlation was found between tumor size and CP%. The other side, the average tumor size in each group was 26.6 mm, 28.7 mm, and 37.8 mm in the Group A, B, and C, respectively. The average tumor size in Group C was significantly greater than those of Group A and B (P<0.01). The presence of gait disturbance in Group C was significantly higher than the other groups (P<0.01). The other side, abnormal ETT and OKP were seen in 32.5% and 31.9% of all patients, respectively. ETT and OKP results improved postoperatively in 67.4% and 68.9% of these patients.

CONCLUSIONS: Abnormal ETT and OKP results showed positive correlations with the tumor size and presence of subjective symptoms. Further, dysfunction of cerebellum and brain stem owing to tumor compression was observed to recover in many cases after surgery.

PMID:34802775 | DOI:10.1016/j.anl.2021.10.010