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Nevin Manimala Statistics

Estimation of the odds ratio in a proportional odds model with censored time-lagged outcome in a randomized clinical trial

Biometrics. 2021 Nov 26. doi: 10.1111/biom.13603. Online ahead of print.

ABSTRACT

In many randomized clinical trials of therapeutics for COVID-19, the primary outcome is an ordinal categorical variable, and interest focuses on the odds ratio (active agent vs. control) under the assumption of a proportional odds model. Although at the final analysis the outcome will be determined for all subjects, at an interim analysis, the status of some participants may not yet be determined, e.g., because ascertainment of the outcome may not be possible until some pre-specified follow-up time. Accordingly, the outcome from these subjects can be viewed as censored. A valid interim analysis can be based on data only from those subjects with full follow up; however, this approach is inefficient, as it does not exploit additional information that may be available on those for whom the outcome is not yet available at the time of the interim analysis. Appealing to the theory of semiparametrics, we propose an estimator for the odds ratio in a proportional odds model with censored, time-lagged categorical outcome that incorporates additional baseline and time-dependent covariate information and demonstrate that it can result in considerable gains in efficiency relative to simpler approaches. A byproduct of the approach is a covariate-adjusted estimator for the odds ratio based on the full data that would be available at a final analysis. This article is protected by copyright. All rights reserved.

PMID:34825704 | DOI:10.1111/biom.13603

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The role of rehabilitation exercises on weight, functional strength and exercise adherence in knee osteoarthritis patients

Curr Rheumatol Rev. 2021 Jul 18. doi: 10.2174/1573397117666210719101551. Online ahead of print.

ABSTRACT

INTRODUCTION: Knee osteoarthritis (OA) is a weight-bearing joint disease and is more common in overweight and obese persons. The objective of this study was to determine the role of rehabilitation exercises (REs) of lower limbs on weight, functional strength, and exercise adherence in overweight and obese knee OA patients.

MATERIALS AND METHOD: The patients were recruited from the Urban community of Lahore, Pakistan. The patients were divided into the rehabilitation group (RG) and control group (CG). The patients in the RG performed the REs of lower limbs and followed the instructions of daily care (IDC), while the patients in the CG only followed the IDC for 12 weeks. Outcome measures were assessed at pre-test before grouping and post-test after 12-weeks of interventions. The measures included: weight, functional strength, and exercise adherence. The Paired Samples t-test (for the normally distributed data) and the Wilcoxon Signed Ranked Test (for the data that was not normally distributed) were used to analyze the differences within groups from pre to post-test measurements. The analysis of variance 2 × 2 factors and the Mann-Whitney U-test were used to analyze the difference of weight and functional strength respectively between the groups.

RESULTS: The patients in the RG reported a statistically significant weight reduction (p < 0.001) and improvement in the functional strength (p < 0.001) within the group. Similarly, the patients in the CG also reported a significant improvement in the scores of functional strength (p = 0.004) within the group. The improvement in the scores of functional strength was greater in the patients of RG than the CG (p < 0.001. Similarly, the patients in the RG reported a statistically significant reduction in weight than the CG (p < 0.001).

CONCLUSION: The REs could improve weight, functional strength and exercise adherence.

PMID:34825640 | DOI:10.2174/1573397117666210719101551

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Contrast-enhanced Ultrasound for Diagnosis of Renal Cystic Mass

Curr Med Imaging. 2021 Jul 19. doi: 10.2174/1573405617666210719141831. Online ahead of print.

ABSTRACT

BACKGROUND: Cystic Renal Cell Carcinoma (CRCC) is often challenging to differentiate from complex cysts with sonographic manifestations of renal carcinoma. Contrast-Enhanced Ultrasound (CEUS) is a new technology, and its clinical utility in the diagnosis of renal cystic mass has not been established.

OBJECTIVE: To analyze the characteristics of CEUS of renal cystic masses and to explore the clinical significance and value of CEUS in the diagnosis of CRCC.

METHODS: This study was a retrospective study. A total of 32 cystic masses from January 2018 to December 2019 were selected. The images of conventional ultrasound (US) and CEUS were confirmed via surgical pathology. The routine US was used to observe the location, shape, size, boundary, cyst wall, internal echo, and blood supply of each cystic mass. CEUS observed contrast enhancement of the cyst wall, cystic septa, and solid nodules of cystic masses.

RESULTS: There were 26 cases of CRCC, 5 cases of renal cysts, and 1 case of renal tuberculosis. The enhancement pattern, degree of enhancement, and pseudocapsular sign by CEUS in benign and malignant masses had statistically significant differences (P<.05). In the diagnosis of CRCC, the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value were 92.3%, 83.3%, 90.6%, 96.0%, and 71.4% for CEUS; 57.6%, 66.7%, 59.3%, 88.2%, and 26.7% for conventional US, respectively. CEUS had a higher sensitivity and accuracy than the conventional US (P<.05). However, the diagnostic specificity, positive predictive value, and negative predictive value of the two methods were not significantly different (P>.05).

CONCLUSION: CEUS is more accurate in the diagnosis of renal cystic masses, and it can be used as an effective imaging method.

PMID:34825641 | DOI:10.2174/1573405617666210719141831

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Nevin Manimala Statistics

Virtual Reality for Hypertension in Tooth Extraction: A Randomized Trial

J Dent Res. 2021 Nov 26:220345211049393. doi: 10.1177/00220345211049393. Online ahead of print.

ABSTRACT

Tooth extraction is one of the most common causes of dental anxiety and pain, leading to the elevation of blood pressure (BP) and heart rate (HR). Such effects may be exaggerated and cause life-threatening accidents in patients with hypertension. Therefore, the pain and anxiety management of these patients is imperative. Virtual reality (VR) has been demonstrated to be a distraction method to relieve anxiety and pain in clinical operations. Thus, we hypothesized that VR can control the elevation of BP and HR in patients with hypertension. In this study, 96 eligible patients with controlled hypertension who needed tooth extraction were randomized to the VR or standard care group by stratified randomization of anxiety grade and gender. Their BP and HR were dynamically monitored. The corresponding systolic and diastolic BP and HR values were selected when systolic BP was at the highest point of the process. BP was converted into mean arterial pressure (MAP) for comparison per the following formula: MAP = (systolic BP + 2 × diastolic BP)/3. Statistical analyses were by intention to treat and conducted in SPSS. Nonparametric rank sum tests were used to compare the difference of ΔMAP and ΔHR between the VR and standard care groups. Multivariate linear regression was applied to evaluate the effect of VR on ΔMAP and ΔHR. The results showed that the VR technique significantly decreased the elevation of MAP (P < 0.001) and HR (P < 0.001), and this effect was found even after adjusting for baseline characteristics and additional surgical procedures (ΔMAP, P < 0.001, R2 = 0.276; ΔHR, P < 0.001, R2 = 0.152). VR did not increase the incidence of adverse events (P = 0.677). In conclusion, the VR technique was effective in controlling BP and HR within an acceptable range and can help manage BP and HR during tooth extraction for patients with hypertension (Chinese Clinical Trial Registry: ChiCTR2100042132).

PMID:34825613 | DOI:10.1177/00220345211049393

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Safety of high-power short pulse single spot diode laser stapedotomy: an experimental animal study

Acta Otolaryngol. 2021 Nov 26:1-5. doi: 10.1080/00016489.2021.2005256. Online ahead of print.

ABSTRACT

BACKGROUND: We present a new method of diode laser stapedoplasty – high-power short-pulse mode with preliminary carbonization of the waveguide and a single spot of laser ablation.

AIMS/OBJECTIVE: The aim of our research is the safety evaluation of presented mode 0.98 µm diode laser cochleostomy in guinea pigs.

MATERIAL AND METHODS: Guinea pigs (n = 10) received 0.98 µm diode laser cochleostomy on one ear under general anesthesia. The control group was based on untreated ears (n = 10). The assessment of auditory function was performed using the distortion product otoacoustic emission (DPOAE) before and 7 d after surgery. To assess the degree of damage from the laser cochleas were extracted for histological examination.

RESULTS: To evaluate the negative impact of laser energy on OHCs and auditory function, we analyzed DPOAE amplitudes for 6400 and 8000 Hz since high frequency. The paired Student’s t-test showed no statistically significant difference between the two groups. The histological examination yielded no statistically significant difference in the number of intact OHCs in the two groups.

CONCLUSION AND SIGNIFICANCE: Our study confirms that the proposed method of high-power short pulse diode laser stapedotomy is safe for the inner ear. Further prospective and randomized clinical trials are required to evaluate the possible benefits of this method.

PMID:34825632 | DOI:10.1080/00016489.2021.2005256

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The development and testing of Thai facial soft tissue thickness data in three-dimensional computerized forensic facial reconstruction

Med Sci Law. 2021 Nov 26:258024211057689. doi: 10.1177/00258024211057689. Online ahead of print.

ABSTRACT

Forensic facial reconstruction is a useful tool to assist the public in recognizing human remains, leading to positive forensic investigation outcomes. To reproduce a virtual face, facial soft tissue thickness is one of the major guidelines to reach the accuracy and reliability for three-dimensional computerized facial reconstruction, a method that is making a significant contribution to improving forensic investigation and identification. This study aimed to develop a facial soft tissue thickness dataset for a Thai population, and test its reliability in the context of facial reconstruction. Three-dimensional facial reconstruction was conducted on four skulls (2 males and 2 females, with ages ranging between 51 to 60 years). Two main tools of three-dimensional computer animation and modeling software-Blender and Autodesk Maya-were used to rebuild the three-dimensional virtual face. The three-dimensional coordinate (x, y, z) cutaneous landmarks on the mesh templates were aligned homologous to the facial soft tissue thickness markers on the three-dimensional skull model. The final three-dimensional virtual face was compared to the target frontal photograph using face pool comparison. Four three-dimensional virtual faces were matched at low to moderate levels, ranging from 30% to 70% accuracy. These results demonstrate that the facial soft tissue thickness database of a Thai population applied in this study could be useful for three-dimensional computerized facial reconstruction purposes.

PMID:34825605 | DOI:10.1177/00258024211057689

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Calcium Score Predicts Mortality After Revascularization in Critical Limb Ischemia

J Endovasc Ther. 2021 Nov 26:15266028211059911. doi: 10.1177/15266028211059911. Online ahead of print.

ABSTRACT

PURPOSE: The calcium score is a measure of vessel wall calcification and has clinical applications when studied in different vascular beds. The presence of vascular calcification in the arteries of the lower limbs is very common in patients with peripheral arterial disease; however, its relationship with the postoperative outcomes in patients undergoing lower limb revascularization is still poorly studied. The aim of this study is to evaluate association between the calcium score of lower limbs and the postoperative outcomes in patients with peripheral arterial disease undergoing revascularization procedures.

METHODOLOGY: We retrospectively analyzed 88 lower limb revascularization procedures in 72 patients with critical limb ischemia who had enhanced computed tomography for preoperative evaluation. The calcium score was calculated, from the angiographic phase of preoperative computed tomography, in the segments of the aorta, iliac, femoropopliteal, and infrapopliteal. It was also calculated the calcium score of the operated limb, and the total calcium score using a standardized method. The outcomes evaluated were the occurrence of acute myocardial infarction, amputation, patency, technical success, and death from any cause. Patients were followed up through a 12 month period.

RESULTS: Among the 88 procedures performed, 31 (43.1%) lesions were classified as Trans-Atlantic Inter-Society Consensus Document II D. There were 66 (75%) endovascular procedures, 16 (18.2%) open surgery, and 6 (6.8%) hybrid interventions. No statistically significant relationship was found between the calcium score of the segments (aorta, iliac, femoropopliteal, infrapopliteal, the operated limb, and total calcium score) and the outcomes of acute myocardial infarction, amputation, patency, and technical success in any of the periods analyzed. The calcium score of the operated limb was higher in patients who died within 30 days and 6 months (6571 vs 2590.6; p=0.026) and (5227.8 vs 2335.3; p=0.036).

CONCLUSION: A standardized calcium score calculation method with the angiographic phase of the computed tomography is feasible and reproducible. Higher values of the calcifications of the operated limb are related to a greater chance of death in the postoperative period. The calcium score of the operated limb can be considered as a marker of clinical severity and prognosis in this group of patients.

PMID:34825606 | DOI:10.1177/15266028211059911

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Is there a relationship between oral hygiene and nutritional status in peritoneal dialysis patients?

Nutr Hosp. 2021 Nov 26. doi: 10.20960/nh.03786. Online ahead of print.

ABSTRACT

Brackground: in the early stages of kidney disease, oral manifestations (gingivitis and periodontitis) may cause premature tooth loss and limit food intake. There is scarce evidence of the relationship between oral hygiene and nutritional status in patients on peritoneal dialysis (PD).

OBJECTIVE: we aimed to assess the relationship of oral hygiene with nutritional, clinical, and physical performance parameters in PD patients.

METHODS: this cross-sectional study included outpatients aged 34-69 years. Oral health questionnaire, nutritional, functional, and clinical assessment tools such as malnutrition inflammation score (MIS), subjective global assessment (SGA), handgrip strength, and gastrointestinal symptoms questionnaire (GSQ) were applied. Patients were divided according to debris, calculus, and simplified oral hygiene index (OHI-S) in two groups: “clean-slightly dirty” and “dirty-very dirty”.

RESULTS: in total, 41 patients were included, those in the “dirty-very dirty” group had a worse nutritional status with higher scores on the MIS tool and worse nutritional diagnosis with SGA as compared to the “clean-slightly dirty” group. The handgrip strength was higher in patients in the best category of oral hygiene, and those with the worst hygiene presented greater severity of gastrointestinal symptoms. The risks of malnutrition in the three indices of oral hygiene with the worst category were statistically significant.

CONCLUSION: poor oral hygiene was associated with poorer nutritional status, lower handgrip, and worse GSQ. Poor oral hygiene might be related to persistent inflammation status and catabolism that favored protein-energy wasting.

PMID:34825569 | DOI:10.20960/nh.03786

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Optimum immunotherapy method according to PD-L1 expression in advanced lung cancer: a network meta-analysis

Future Oncol. 2021 Nov 26. doi: 10.2217/fon-2021-1217. Online ahead of print.

ABSTRACT

Aim: To compare the survival of advanced lung cancer patients treated with immune checkpoint inhibitors in different PD-L1 expression. Methods: We performed a network meta-analysis based on 25 trials involving 12,224 patients with different PD-L1 expression levels. Results: The results showed platinum-based chemotherapy plus pembrolizumab or nivolumab and ipilimumab was associated with the best survival rates for patients with <1% PD-L1 expression, while only platinum-based chemotherapy plus pembrolizumab produced better survival than chemotherapy in patients with 1-49% PD-L1 expression. As for patients with ≥50% PD-L1 expression, platinum-based chemotherapy plus pembrolizumab/atezolizumab and pembrolizumab/cemiplimab monotherapy were associated with better survival than chemotherapy. Conclusion: These results provide reference for selecting the optimum immunotherapy method based on the expression of PD-L1 in patients with advanced lung cancer.

PMID:34825576 | DOI:10.2217/fon-2021-1217

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Questionnaire investigation of radiation rectal injury with anxiety, depression and somatic disorder

Zhonghua Wei Chang Wai Ke Za Zhi. 2021 Nov 25;24(11):984-990. doi: 10.3760/cma.j.cn441530-20210804-00308.

ABSTRACT

Objective: To observe the incidence and treatment of radiation rectal injury complicated with anxiety, depression and somatic symptom disorder. Methods: A cross-sectional survey research method was carried out. Patients with radiation rectal injury managed by members of the editorial board of Chinese Journal of Gastrointestinal Surgery were the subjects of investigation. The inclusion criteria of the survey subjects: (1) patients suffered from pelvic tumors and received pelvic radiotherapy; (2) colonoscopy showed inflammatory reaction or ulcer in the rectum. Exclusion criteria: (1) patient had a history of psycho-somatic disease before radiotherapy; (2) patient was unable to use a smart phone, unable to read and understand the questions in the questionnaire displayed on the phone; (3) patient refused to sign an informed consent form. According to the SOMA self-rating scale, PHQ-15 self-rating scale, GAD-7 and PHQ-9 self-rating scale, the electronic questionnaire of “Psychological Survey of Radiation Proctitis” was designed. The questionnaire was sent to patients with radiation rectal injury managed by the committee through the WeChat group. Observational indicators: (1) radiation rectal injury symptom assessment: using SOMA self-rating scale, radiation rectal injury symptom classification: mild group (≤3 points), moderate group (4-6 points) and severe group (> 6 points); (2) incidence of anxiety, depression and physical disorder: using GAD-7, PHQ-9 and PHQ-15 self-rating scales respectively for assessment; (3) correlation of radiation rectal injury symptom grading with anxiety, depression, and somatic symptom disorder. Results: Seventy-one qualified questionnaires were collected, of which 41 (56.9%) were from Guangzhou. Among the 71 patients, 6 were males and 65 were females; the mean age was (55.7±9.3) years old and 48 patients (67.6%) were less than 60 years old; the median confirmed duration of radiation rectal injury was 2.0 (1.0, 5.0) years. (1) Evaluation of symptoms of radiation rectal injury: 18 cases of mild (25.4%), 27 cases of moderate (38.0%), and 26 cases of severe (36.6%). (2) Incidence of anxiety, depression and somatic disorder: 12 patients (16.9%) without comorbidities; 59 patients (83.1%) with anxiety, depression, or somatic disorder, of whom 2 patients only had anxiety, 1 patient only had depression, 9 only had somatic disorder, 2 had anxiety plus depression, 4 had anxiety plus somatic disorder, 2 had depression plus somatic disorder, and 40 had all three symptoms. (3) correlation of radiation rectal injury grading with anxiety, depression, and somatic symptom disorder: as compared to patients in mild group and moderate group, those in severe group had higher severity of anxiety and somatic symptom disorder (Z=-2.143, P=0.032; Z=-2.045, P=0.041), while there was no statistically significant difference of depression between mild group and moderate group (Z=-1.176, P=0.240). Pearson correlation analysis revealed that radiation rectal injury symptom score was positively correlated with anxiety (r=0.300, P=0.013), depression (r=0.287, P=0.015) and somatic symptom disorder (r=0.344, P=0.003). Conclusions: The incidence of anxiety, depression, and somatic symptom disorder in patients with radiation rectal injury is extremely high. It is necessary to strengthen the diagnosis and treatment of somatic symptom disorder, so as to alleviate the symptoms of patients with pelvic perineum pain and improve the quality of life.

PMID:34823299 | DOI:10.3760/cma.j.cn441530-20210804-00308