The Impact of Source of Funding on the Outcome of Clinical Trials in India

2018 ◽  
Vol 18 (2) ◽  
pp. 201-216
Author(s):  
Benhur Ruqsana
Keyword(s):  
Clinical Trials ◽  
Regression Analysis ◽  
Multivariate Logistic Regression Analysis ◽  
Large Sample Size ◽  
Multivariate Logistic Regression ◽  
Probability Of Success ◽  
Pharmaceutical Industries ◽  
Level Of Significance ◽  
Clinical Trials Registry ◽  
The Impact

In recent times, there has been a surge of clinical trials in India. These trials are funded by different agents such as pharmaceutical industries, hospitals, research institutions, etc. Categorising the sponsors as pharmaceutical and non-pharmaceutical, this article tries to address the question whether the source of funding of the trials affects its outcome favourably. The study is carried out with 255 trials registered in Clinical Trials Registry-India from the year 2007 to 2009. Multivariate logistic regression analysis suggests that the trials conducted by pharmaceutical industries have significantly (at 10% level of significance) higher probability of success as compared to those sponsored by non-pharmaceutical industries. The possible reasons for this association are that trials conducted by pharmaceutical industries are in higher phase of study, use placebo as a control, are conducted in multiple centres and consist of large sample size. JEL: I11, C51

Impact of coronaphobia on treatment and follow-up compliance of cancer patients

2021 ◽  
Author(s):  
Baran Akagunduz ◽  
Muhammet Ozer ◽  
Cengiz Karacin ◽  
Muhammed Mustafa Atcı ◽  
Hasan Cagrı Yıldırım ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Multivariate Analysis ◽  
Regression Analysis ◽  
Cancer Patients ◽  
Multivariate Logistic Regression Analysis ◽  
Educational Status ◽  
Multivariate Logistic Regression ◽  
Treatment Type ◽  
The Impact

The aim of this study was to assess the impact of coronaphobia on treatment and follow-up compliance in cancer patients. The records of 230 cancer patients were reviewed. Coronaphobia was assessed via the validated COVID-19 Phobia Scale (C19P-S). A total of 64% of the patients had a high coronaphobia score. Among them, 59% were noncompliant. In multivariate logistic regression analysis, low educational status, treatment type, following COVID-19 news, having knowledge about COVID-19 transmission and higher C19P-S score were associated with noncompliance (p = 0.006, p < 0.001, p = 0.002, p = 0.002 and p = 0.001, respectively). Multivariate analysis revealed that having knowledge about COVID-19 transmission was related to a higher C19P-S score (p = 0.001). The cancer patients studied had significant coronaphobia. Moreover, greater coronaphobia was significantly associated with noncompliance with follow-up and treatment.

scholarly journals Efficacy of flurbiprofen axetil for preventing postanesthetic shivering in patients undergoing gynecologic laparotomy surgeries

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Atsushi Kotera
Keyword(s):  
Logistic Regression ◽  
Regression Analysis ◽  
Postoperative Pain ◽  
Logistic Regression Analysis ◽  
Pain Control ◽  
Multivariate Logistic Regression Analysis ◽  
Multivariate Logistic Regression ◽  
Postoperative Pain Control ◽  
Flurbiprofen Axetil ◽  
Postanesthetic Shivering

Abstract Background Postanesthetic shivering is an unpleasant adverse event in surgical patients. A nonsteroidal anti-inflammatory drug has been reported to be useful in preventing postanesthetic shivering in several previous studies. The aim of this study was to evaluate the efficacy of flurbiprofen axetil being a prodrug of a nonsteroidal anti-inflammatory drug for preventing postanesthetic shivering in patients undergoing gynecologic laparotomy surgeries. Method This study is a retrospective observational study. I collected data from patients undergoing gynecologic laparotomy surgeries performed between October 1, 2019, and September 30, 2020, at Kumamoto City Hospital. All the patients were managed with general anesthesia with or without epidural analgesia. The administration of intravenous 50 mg flurbiprofen axetil for postoperative pain control at the end of the surgery was left to the individual anesthesiologist. The patients were divided into two groups: those who had received intravenous flurbiprofen axetil (flurbiprofen group) and those who had not received intravenous flurbiprofen axetil (non-flurbiprofen group), and I compared the frequency of postanesthetic shivering between the two groups. Additionally, the factors presumably associated with postanesthetic shivering were collected from the medical charts. Intergroup differences were assessed with the χ2 test with Yates’ correlation for continuity category variables. The Student’s t test was used to test for differences in continuous variables. Furthermore, a multivariate logistic regression analysis was performed to elucidate the relationship between the administration of flurbiprofen axetil and the incidence of PAS. Results I retrospectively examined the cases of 141 patients aged 49 ± 13 (range 21-84) years old. The overall postanesthetic shivering rate was 21.3% (30 of the 141 patients). The frequency of postanesthetic shivering in the flurbiprofen group (n = 31) was 6.5%, which was significantly lower than that in the non-flurbiprofen group (n = 110), 25.5% (p value = 0.022). A multivariate logistic regression analysis showed that administration of flurbiprofen axetil was independently associated with a reduced incidence of postanesthetic shivering (odds ratio 0.12; 95% confidence interval, 0.02-0.66, p value = 0.015). Conclusions My result suggests that intraoperative 50 mg flurbiprofen axetil administration for postoperative pain control is useful to prevent postanesthetic shivering in patients undergoing gynecologic laparotomy surgeries.

scholarly journals The association between hypoglycemia and glycemic variability in elderly patients with type 2 diabetes: a prospective observational study

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Takahisa Handa ◽  
Akinobu Nakamura ◽  
Aika Miya ◽  
Hiroshi Nomoto ◽  
Hiraku Kameda ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Logistic Regression ◽  
Regression Analysis ◽  
Observational Study ◽  
Elderly Patients ◽  
Prospective Observational Study ◽  
Multivariate Logistic Regression Analysis ◽  
Glycemic Variability ◽  
Multivariate Logistic Regression

Abstract Background This study aimed to explore predictive factors of time below target glucose range (TBR) ≥ 1% among patients’ characteristics and glycemic variability (GV) indices using continuous glucose monitoring data in elderly patients with type 2 diabetes. Methods We conducted a prospective observational study on 179 (71 female) Japanese outpatients with type 2 diabetes aged ≥ 65 years. The characteristics of the participants with TBR ≥ 1% were evaluated by multivariate logistic regression analysis. Receiver-operating characteristic (ROC) curve analyses of GV indices, comprising coefficient of variation (CV), standard deviation, and mean amplitude of glycemic excursions, were performed to identify the optimal index for the identification of patients with TBR ≥ 1%. Results In the multivariate logistic regression analysis, none of the clinical characteristics, including HbA1c and C-peptide index, were independent markers for TBR ≥ 1%, while all three GV indices showed significant associations with TBR ≥ 1%. Among the three GV indices, CV showed the best performance based on the area under the curve in the ROC curve analyses. Conclusions Among elderly patients with type 2 diabetes, CV reflected TBR ≥ 1% most appropriately among the GV indices examined. Trial registration UMIN-CTR: UMIN000029993. Registered 16 November 2017

scholarly journals Risk factors for tissue expander infection in scar reconstruction: a retrospective cohort study of 2374 consecutive cases

2020 ◽  
Vol 8 ◽  
Author(s):  
Chen Dong ◽  
Minhui Zhu ◽  
Luguang Huang ◽  
Wei Liu ◽  
Hengxin Liu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Logistic Regression ◽  
Regression Analysis ◽  
Treatment Failure ◽  
Logistic Regression Analysis ◽  
Disease Duration ◽  
Multivariate Logistic Regression Analysis ◽  
Tissue Expansion ◽  
Multivariate Logistic Regression ◽  
Hematoma Evacuation

Abstract Background Tissue expansion is used for scar reconstruction owing to its excellent clinical outcomes; however, the complications that emerge from tissue expansion hinder repair. Infection is considered a major complication of tissue expansion. This study aimed to analyze the perioperative risk factors for expander infection. Methods A large, retrospective, single-institution observational study was carried out over a 10-year period. The study enrolled consecutive patients who had undergone tissue expansion for scar reconstruction. Demographics, etiological data, expander-related characteristics and postoperative infection were assessed. Univariate and multivariate logistic regression analysis were performed to identify risk factors for expander infection. In addition, we conducted a sensitivity analysis for treatment failure caused by infection as an outcome. Results A total of 2374 expanders and 148 cases of expander infection were assessed. Treatment failure caused by infection occurred in 14 expanders. Multivariate logistic regression analysis identified that disease duration of ≤1 year (odds ratio (OR), 2.07; p &lt; 0.001), larger volume of expander (200–400 ml vs &lt;200 ml; OR, 1.74; p = 0.032; &gt;400 ml vs &lt;200 ml; OR, 1.76; p = 0.049), limb location (OR, 2.22; p = 0.023) and hematoma evacuation (OR, 2.17; p = 0.049) were associated with a high likelihood of expander infection. Disease duration of ≤1 year (OR, 3.88; p = 0.015) and hematoma evacuation (OR, 10.35; p = 0.001) were so related to high risk of treatment failure. Conclusions The rate of expander infection in patients undergoing scar reconstruction was 6.2%. Disease duration of &lt;1 year, expander volume of &gt;200 ml, limb location and postoperative hematoma evacuation were independent risk factors for expander infection.

Donepezil Combined with DL-3-n-Butylphthalide Delays Cognitive Decline in Patients with Mild to Moderate Alzheimer’s Disease: A Multicenter, Prospective Cohort Study

2021 ◽  
Vol 80 (2) ◽  
pp. 673-681
Author(s):  
Jin Wang ◽  
Xiaojuan Guo ◽  
Wenhui Lu ◽  
Jie Liu ◽  
Hong Zhang ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Logistic Regression ◽  
Regression Analysis ◽  
Cohort Study ◽  
Prospective Cohort ◽  
Daily Living ◽  
Multivariate Logistic Regression Analysis ◽  
Multivariate Logistic Regression ◽  
Significant Difference

Background: Vascular factors and mitochondria dysfunction contribute to the pathogenesis of Alzheimer’s disease (AD). DL-3-n-butylphthalide (NBP) has an effect in protecting mitochondria and improving microcirculation. Objective: The aim was to investigate the effect of donepezil combined NBP therapy in patients with mild-moderate AD. Methods: It was a prospective cohort study. 92 mild-moderate AD patients were classified into the donepezil alone group (n = 43) or the donepezil combined NBP group (n = 49) for 48 weeks. All patients were evaluated with Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS-cog), Clinician’s Interview-Based Impression of Change plus caregiver input (CIBIC-plus), Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), and Neuropsychiatric Inventory (NPI) every 12 weeks. All patients were monitored for adverse events (AEs). The efficacy was analyzed using multivariate logistic regression analysis. Results: The multivariate logistic regression analysis showed that the changes of ADAS-cog score (OR = 2.778, 95% CI: [1.087, 7. 100], p = 0.033) and ADCS-ADL score (OR = 2.733, 95% CI: [1.002, 7.459], p = 0.049) had significant difference between donepezil alone group and donepezil combined NBP group, while the changes of NPI (OR = 1.145, 95% CI: [0.463, 2.829], p = 0.769), MMSE (OR = 1.563, 95% CI: [0.615, 3.971], p = 0.348) and CIBIC-plus (OR = 2.593, 95% CI: [0.696, 9.685], p = 0.156) had no significant difference. The occurrence of AEs was similar in the two groups. Conclusion: Over the 48-week treatment period, donepezil combined NBP group had slower cognitive decline and better activities of daily living in patients with mild to moderate AD. These indicated that the multi-target therapeutic effect of NBP may be a new choice for AD treatment.

Risk Factors for Aortic Valve Calcification in Patients on Regular Hemodialysis

2009 ◽  
Vol 32 (3) ◽  
pp. 173-179 ◽  
Author(s):  
Dejan Petrović ◽  
Radmila Obrenović ◽  
Biljana Stojimirović
Keyword(s):  
Risk Factors ◽  
Regression Analysis ◽  
Risk Factor ◽  
Aortic Valve ◽  
Independent Risk Factor ◽  
Multivariate Logistic Regression Analysis ◽  
Multivariate Logistic Regression ◽  
Aortic Valve Calcification ◽  
Valve Calcification ◽  
Regular Hemodialysis

Introduction Aortic valve calcification (AVC) accelerates development of aortic valve stenosis and cardiovascular complications. Hyperphosphatemia is one of the key risk factors for aortic valve calcification. Aim The aim of this study was to evaluate the prevalence of AVC in patients on regular hemodialysis and to assess the impact of different factors on its appearance. Method: The study investigated a total of 115 patients treated in the Hemodialysis Department of the Urology and Nephrology Clinic at the Kragujevac Clinical Center in Serbia. The variables investigated were: serum albumin, C-reactive protein (CRP), homocysteine, total cholesterol, LDL-cholesterol (LDL-C), HDL-cholesterol (HDL-C), triglycerides (TG), Apolipoprotein A-I (Apo A-I), Apolipoprotein B (Apo B) and lipoprotein (a), calcium, phosphate and parathormone, and calcium-phosphorus product (Ca × P). Patients were evaluated by echocardiography for AVC. Statistical analysis included univariate and multivariate logistic regression analysis. Results Univariate regression analysis showed that serum phosphate levels and Ca × P are the most important risk factors for AVC (p<0.001). Multivariate logistic regression analysis revealed that hyperphosphatemia is an independent risk factor for AVC (p<0.001). Conclusion Hyperphosphatemia is an independent risk factor for aortic valve calcification.

Sign in / Sign up

Export Citation Format

Share Document