Category: Nevin Manimala

Pharmacol Res Perspect. 2021 Apr;9(2):e00729. doi: 10.1002/prp2.729.

ABSTRACT

With the improvements in relevant policies, laws, and regulations regarding drug clinical trials in China, the quantity and quality of drug clinical trials have gradually improved, and the development prospects of drug clinical trials for endocrine disorders and metabolism and nutrition disorders are promising. Based on information from the clinical trials from the online drug clinical trial registration platform of the National Medical Products Administration, we aimed to review and evaluate the development of clinical trials of drugs for endocrine disorders and metabolism and nutrition disorders in mainland China from 2010 to 2019, as well as the trends over time. A total of 861 trials were carried out on 254 types of drugs for endocrine disorders and metabolism and nutrition disorders, among which 531 (61.67%) involved endocrine disorders, and 330 (38.33%) addressed metabolism and nutrition disorders. The annual number of clinical trials has been increasing gradually, with a significant increase in 2017. Among them, the proportion of clinical trials with Chinese epidemiological characteristics was relatively large (Wu, Annual Report on Development Health Management and Health Industry in China, 2018). The largest number of trials were for diabetes drugs (55.63%), followed by trials of drugs for hyperlipidemia (19.4%) and those for hyperuricemia (7.9%). It was found that the geographical area of the leading units also showed obvious unevenness according to the analysis of the test unit data. Based on the statistics and evaluation of the data, comprehensive information is provided to support the cooperation of global pharmaceutical R&D companies and research units in China and the development of international multicenter clinical trials in China. This work additionally provides clinical trial units with a self-evaluation of scientific research competitiveness and hospital development strategies. At the same time, it provides a reference with basic data for sponsors and stakeholders in these trials to determine their development strategy goals.

PMID:33660404 | DOI:10.1002/prp2.729

Cancer Rep (Hoboken). 2021 Mar 3:e1349. doi: 10.1002/cnr2.1349. Online ahead of print.

ABSTRACT

BACKGROUND: Oral and oropharyngeal cancer are significant health problems. They are both life-threatening conditions usually diagnosed at an advanced stage causing survival rates to decline.

AIM: To assess and compare practices, knowledge and attitude regarding oral and oropharyngeal cancer between dental and medical practitioners.

METHODS: A cross-sectional study was conducted to assess knowledge, attitude and practices of oral and oropharyngeal cancer among dental and medical practitioners at King Abdulaziz Medical City, Riyadh, Saudi Arabia. 360 participants were included in the study using a convenient sampling technique. Participants were approached in their clinics and printed self-administered questionnaire were handed over to them after signing a written consent form. Frequency distribution and Chi-Square test were used for the statistical analysis and the level of significance was set at P value of .05 or less.

RESULTS: A total of 174 participants responded. Assessment of oral and oropharyngeal cancer knowledge between dental practitioners and medical practitioners showed comparable results. Regarding practices, a significant difference was seen between medical practitioners and dental practitioners in determining the duration of intra-oral ulcer to consider urgent referral (P = .006) and in number of referrals made in relation to suspicious oral lesions (P = .002). Moreover, a significant difference (P = .006) was seen between medical practitioners and dental practitioners in determining the duration of intra-oral ulcer to consider urgent referral.

CONCLUSION: Medical and dental practitioners showed areas of differences in practice, attitude and knowledge of oral and oropharyngeal cancer that when addressed would lead to improved survival rates.

PMID:33660423 | DOI:10.1002/cnr2.1349

J Clin Nurs. 2021 Mar 4. doi: 10.1111/jocn.15736. Online ahead of print.

ABSTRACT

AIMS: The aim of this study was to determine the compliance with treatment and fear of hypoglycemia in patients with type 2 diabetes.

BACKGROUND: One of the important problems of patients are the fear of hypoglycemia and compliance with treatment, which impairs general health and quality of life. It is believed that nurses contribute to the improvement of compliance with treatment in patients with type 2 diabetes, a decrease in hypoglycemia rates.

DESIGN: This study was conducted as a descriptive study. The STROBE checklist was used.

METHODS: The study was carried out with 376 patients with type 2 diabetes between January-June 2019. The Patient Information Form, Type 2 Diabetes Mellitus Treatment Patient Compliance Scale, and Hypoglycemia Fear Survey applied and SAS 9.4 package program was used for statistical analysis. Data were evaluated using descriptive statistics, t-test, chi-square, and variation analysis.

RESULTS: It was determined that 58.2% of the participants were female, mean age was 62.19 ± 9.60, 57.7% were primary school graduates, 50.3% were using oral antidiabetic, 34.5% were using oral antidiabetic and insulin. Patients’ compliance with treatment was moderate (60.9%). According to the mean score of the Hypoglycemia Fear Survey, the patients had a low level of fear of hypoglycemia ( X– =1.20). There was a statistically significant difference between compliance and fear of hypoglycemia and education, economic status, self-monitoring of blood glucose, physical activity, education about diabetes (p<0.05). Patients with type 2 diabetes had decreased compliance with treatment with increased fear of hypoglycemia (p <0.05).

CONCLUSION: The participants’ compliance with the treatment was moderate and the fear of hypoglycemia mean score was low. Nursing interventions should be planned to increase compliance with treatment and reduce the fear of hypoglycemia in patients with type 2 diabetes.

RELEVANCE TO CLINICAL PRACTICE: Assessing the fear of hypoglycemia and the level of compliance with treatment by healthcare professionals, especially nurses, in patients with type 2 diabetes, and providing education on this subject can be helpful in reducing the fear of hypoglycemia, increasing treatment compliance and providing optimal glycemic control.

PMID:33660356 | DOI:10.1111/jocn.15736

Aust Endod J. 2021 Mar 3. doi: 10.1111/aej.12496. Online ahead of print.

ABSTRACT

This study aimed to compare the shaping ability of ProTaper Next (PTN), HyFlex EDM (HEDM) and One Curve (OC) systems manufactured via different thermal treatment methods in simulated S-shaped canals. Sixty S-shaped canals in clear resin blocks were enlarged to a final apical size of 25 using PTN, HEDM and OC instruments (n = 20 canals/group). Composite images were obtained by superimposing pre- and post-preparation images. The amount of removed resin was measured perpendicularly to the canal surface in 22 points. Prepared canal width and canal transportation at different levels were determined. Canal aberrations were also recorded. Data were statistically analysed using analysis of variance, the Kruskal-Wallis and the chi-square tests at a 0.05 significance level. OC produced the most conservative enlargement and better maintained particularly the apical curvature of the S-shaped canals than HEDM and PTN. OC and HEDM better maintained the canal terminus and coronal curvature than PTN.

PMID:33660339 | DOI:10.1111/aej.12496

J Vet Intern Med. 2021 Mar 4. doi: 10.1111/jvim.16076. Online ahead of print.

ABSTRACT

BACKGROUND: Most dogs with sinonasal tumors (SNT) treated with radiation therapy (RT) died because of local disease progression.

HYPOTHESIS/OBJECTIVES: Our hypothesis is that the majority of local failure and residual disease would occur within the radiation field.

ANIMALS: Twenty-two dogs with SNT treated with RT.

METHODS: Retrospective cohort study.

INCLUSION CRITERIA: dogs with SNT receiving 10 daily fractions of 4.2 Gy with intensity modulated radiation therapy (IMRT)/image guided radiation therapy (IGRT) and follow-up cone beam computed tomography (CBCT). Each CBCT was registered with the original radiation planning CT and the gross tumor volume (GTV) contoured. The GTV was classified as residual (GTVr) or a failure (GTVf). The dose statistic for each GTV was calculated with the original IMRT plan. For GTVf, failures were classified as “in-field,” “marginal,” or “out-field” if at least 95, 20-95, or less than 20% of the volume of failure was within 95% (D95) of the total prescription dose, respectively.

RESULTS: There were 52 follow-up CBCT/CTs. Overall there was a GTVr for 20 dogs and GTVf for 16 dogs. The majority of GTVr volume was within the original GTV. GTVf analysis showed that 75% (12/16) were “in-field,” 19% (3/16) were “marginal” and 6% (1/16) were “out-field.”

CONCLUSION AND CLINICAL IMPORTANCE: In-field failures are the main pattern for local recurrence, and there is evidence of radioresistant subvolumes within the GTV.

PMID:33660342 | DOI:10.1111/jvim.16076

Adv Respir Med. 2021;89(1):30-36. doi: 10.5603/ARM.a2021.0014.

ABSTRACT

INTRODUCTION: Narrow band imaging (NBI) video bronchoscopy provides better visualisation of submucosal vascular patterns in malignant airway lesions compared to white light bronchoscopy. This analytical cross-sectional study was aimed to look for any relationship between these NBI vascular patterns and the histologic type of lung cancer.

MATERIAL AND METHODS: After screening 78 patients with suspected lung cancer, 53 subjects underwent video bronchoscopy. Thirty-two patients showing abnormal bronchial mucosa or endobronchial growth with any of the NBI vascular patterns on bronchoscopy were enrolled in the study. These abnormal areas were then biopsied and sent for histologic examination.

RESULTS: NBI bronchoscopy revealed a dilated tortuous vascular pattern in 54.8% of the patients, a non-specific pattern in 32%, a dotted pattern in 9.7% and an abrupt ending vessels pattern in 3.2% of the patients. We did not find any statistically significant relationship between a dilated tortuous pattern and squamous-cell carcinoma (p = 0.48), adenocarcinoma (p = 0.667) or small-cell carcinoma (p = 1); between a dotted pattern and squamous-cell carcinoma (p = 1), adenocarcinoma (p = 0.54) or small-cell carcinoma (p = 1), and between an abrupt ending capillary pattern and squamous-cell carcinoma (p = 1), adenocarcinoma (p = 1) or small-cell carcinoma (p =1).

CONCLUSION: No relationship exists between NBI vascular patterns and the histology of lung cancer. Endobronchial lesions showing any vascular pattern on NBI needs to be adequately sampled for proper histologic and molecular studies in lung cancer patients.

PMID:33660246 | DOI:10.5603/ARM.a2021.0014

Adv Respir Med. 2021;89(1):37-42. doi: 10.5603/ARM.a2021.0024.

ABSTRACT

INTRODUCTION: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is the standard diagnostic method for sampling mediastinal and hilar lymph nodes. Non-diagnostic samples have led some pulmonologists to add a miniforceps biopsy (EBUS-TBFB) in order to increase diagnostic yield. Our study aims to analyze the impact of adding EBUS-TBFB to the EBUS-TBNA in cases where Rapid On-site Evaluation (ROSE) was negative for malignancy or was non-diagnostic.

MATERIAL AND METHODS: This retrospective chart review included 91 patients who were aged 18-90 years old and underwent EBUS with both TBNA and TBFB between January 1, 2013 and July 1, 2018.

RESULTS: There was no significant statistical difference in the diagnostic yield of TBNA vs TBFB with a McNemar value of 0.167, and this conclusion was the same when stratified by race, age and lymph node size. Using TBNA as a gold standard, the sensitivity and specificity of TBFB was 87% and 69%, respectively. Out of the non-diagnostic TBNA samples on ROSE and cell-block, subsequent TBFB resulted in additional pathologic diagnoses in 16% of cases, of which 67% were non-caseating granulomas. Furthermore, two additional malignant cases were identified by TBFB consisting of small cell carcinoma and non-Hodgkin’s lymphoma.

CONCLUSION: In conclusion, TBFB is a useful adjunctive tool in the diagnosis of non-malignant conditions (i.e. granulomatous diseases) with the potential to spare the patient from more invasive surgical biopsies. Training of future fellows in performing TBFB in addition to TBNA should be strongly encouraged.

PMID:33660247 | DOI:10.5603/ARM.a2021.0024

Med Phys. 2021 Mar 3. doi: 10.1002/mp.14820. Online ahead of print.

ABSTRACT

PURPOSE: The modulation transfer function (MTF) is widely used as an objective metric of spatial resolution of medical imaging systems. Despite advances in capability for 3D isotropic spatial resolution in CT and cone-beam CT (CBCT), MTF evaluation for such systems is typically reported only in the axial plane, and practical methodology for assessment of fully 3D spatial resolution characteristics is lacking. This work reviews fundamental theoretical relationships of 2D and 3D spread functions and reports practical methods and test tools for analysis of 3D MTF in CBCT.

METHODS: Fundamental aspects of 2D and 3D MTF measurement are reviewed within a common notational framework, and three MTF test tools with analysis code are reported and made available online (https://istar.jhu.edu/downloads/): (i) a multi-wire tool for measurement of the axial plane MTF [denoted MTF(f_r ;φ=0°), where φ is the measurement angle out of the axial plane] as a function of position in the axial plane; (ii) a wedge tool for measurement of the MTF in any direction in the 3D Fourier domain [e.g., φ = 45°, denoted MTF(f_r ;φ=45°)]; and (iii) a sphere tool for measurement of the MTF in any or all directions in the 3D Fourier domain. Experiments were performed on a mobile C-arm with CBCT capability, showing that MTF(f_r ;φ=45°) yields an informative 1D representation of the overall 3D spatial resolution characteristics, capturing important characteristics of the 3D MTF that might be missed in conventional analysis. The effects of anisotropic filters and detector readout mode were investigated, and the extent to which a system can be said to provide “isotropic” resolution was evaluated by quantitative comparison of MTF at various φ.

RESULTS: All three test tools provided consistent measurement of MTF(f_r ;φ=0°), and the wedge and sphere tools demonstrated how measurement of the MTF in directions outside the axial plane (|φ|>0°) can reveal spatial resolution characteristics to which conventional axial MTF measurement is blind. The wedge tool was shown to reduce statistical measurement error compared to the sphere tool due to improved sampling, and the sphere tool was shown to provide a basis for measurement of the MTF in any or all directions (outside the null cone) from a single scan. The C-arm system exhibited non-isotropic spatial resolution with conventional non-isotropic 1D apodization filters (i.e., frequency cutoff filters) – which is common in CBCT – and implementation of isotropic 2D apodization yielded quantifiably isotropic MTF. Asymmetric pixel binning modes were similarly shown to impart non-isotropic effects on the 3D MTF, and the overall 3D MTF characteristics were evident in each case with a single, 1D measurement of the 1D MTF(f_r ;φ=45°).

CONCLUSION: Three test tools and corresponding MTF analysis methods were presented within a consistent framework for analysis of 3D spatial resolution characteristics in a manner amenable to routine, practical measurements. Experiments on a CBCT C-arm validated many intuitive aspects of 3D spatial resolution and quantified the extent to which a CBCT system may be considered to have isotropic resolution. Measurement of MTF(f_r ;φ=45°) provided a practical 1D measure of the underlying 3D MTF characteristics and is extensible to other CT or CBCT systems offering high, isotropic spatial resolution.

PMID:33660261 | DOI:10.1002/mp.14820

Health Serv Res. 2021 Mar 3. doi: 10.1111/1475-6773.13645. Online ahead of print.

ABSTRACT

OBJECTIVE: We examine whether broadened access to Medicaid helped insulate households from declines in health coverage and health care access linked to the 2007-2009 Great Recession.

DATA SOURCE: 2004-2010 Behavioral Risk Factor Surveillance System (BRFSS).

STUDY DESIGN: Flexible difference-in-difference regressions were used to compare the impact of county-level unemployment on health care access in states with generous Medicaid eligibility guidelines versus states with restrictive guidelines.

DATA COLLECTION/EXTRACTION METHODS: Nonelderly adults (aged 19-64) in the BRFSS were linked to county unemployment rates from the Bureau of Labor Statistics’ Local Area Unemployment Statistics Program. We created a Medicaid generosity index by simulating the share of a nationally representative sample of adults that would be eligible for Medicaid under each state’s 2007 Medicaid guidelines using data from the 2007 Current Population Survey’s Annual Social and Economic Supplement.

PRINCIPAL FINDINGS: A percentage point (PPT) increase in the county unemployment rate was associated with a 1.3 PPT (95% CI: 0.9-1.6, P < .01) increase in the likelihood of being uninsured and a 0.86 PPT (95% CI: 0.6-1.1, P < .01) increase in unmet medical needs due to cost in states with restrictive Medicaid eligibility guidelines. Conversely, a one PPT increase in unemployment was associated with only a 0.64 PPT (P < .01) increase in uninsurance among states with the most generous eligibility guidelines. Among states in the fourth quartile of generosity (ie, most generous), rises in county-level unemployment were associated with a 0.68 PPT (P < .10) increase in unmet medical needs due to cost-a 21% smaller decrease relative to states with the most restrictive Medicaid eligibility guidelines.

CONCLUSIONS: Increased access to Medicaid during the Great Recession mitigated the effects of increased unemployment on the rate of unmet medical need, particularly for adults with limited income.

PMID:33660277 | DOI:10.1111/1475-6773.13645

J Pharmacokinet Pharmacodyn. 2021 Mar 3. doi: 10.1007/s10928-021-09743-2. Online ahead of print.

ABSTRACT

The quantitative description of individual observations in non-linear mixed effects models over time is complicated when the studied biomarker has a pulsatile release (e.g. insulin, growth hormone, luteinizing hormone). Unfortunately, standard non-linear mixed effects population pharmacodynamic models such as turnover and precursor response models (with or without a cosinor component) are unable to quantify these complex secretion profiles over time. In this study, the statistical power of standard statistical methodology such as 6 post-dose measurements or the area under the curve from 0 to 12 h post-dose on simulated dense concentration-time profiles of growth hormone was compared to a deconvolution-analysis-informed modelling approach in different simulated scenarios. The statistical power of the deconvolution-analysis-informed approach was determined with a Monte-Carlo Mapped Power analysis. Due to the high level of intra- and inter-individual variability in growth hormone concentrations over time, regardless of the simulated effect size, only the deconvolution-analysis informed approach reached a statistical power of more than 80% with a sample size of less than 200 subjects per cohort. Furthermore, the use of this deconvolution-analysis-informed modelling approach improved the description of the observations on an individual level and enabled the quantification of a drug effect to be used for subsequent clinical trial simulations.

PMID:33660229 | DOI:10.1007/s10928-021-09743-2