INTRODUCTION

Documenting a research participant’s awareness of the bill of rights is achieved with an informed consent. In recent years, the informed consent document has increasingly become confounding to research participants in its complexity. As such, the awareness of research participants’ bill of rights has emerged as a lingering issue since studies that test awareness of research participants’ bill of rights are limited. Hence, this study aimed to determine the participants’ awareness of the bill of rights after an educational intervention.

A quasi-experimental study was done where participants’ awareness of clinical trial participants’ bill of rights was determined after an educational intervention.

There was a significant difference (pCONCLUSIONS

Significant difference in the awareness of bill of rights was observed after the educational intervention. Additional intervention could be given to participants who are females, of older age group (middle age and older), did not complete high school, and the unemployed when they participate in clinical trials to ensure their awareness of the bill of rights of clinical trial participants. Varied learning materials must be given to participants to emphasize the clinical research objectives and activities as well.

Background: Virgin coconut oil (VCO) has anti-viral and anti-inflammatory properties, making it a potential therapeutic candidate against COVID-19 infection. Objective: To determine the efficacy and safety of VCO as adjunctive therapy for hospitalized patients with COVID-19. Methods: We conducted a randomized, open-label controlled trial involving laboratory-confirmed COVID-19 patients admitted at the Philippine General Hospital. The study participants were randomized to the intervention group who received virgin coconut oil with local standard of care, or to the control group who received local standard of care alone. Results: We enrolled 39 participants into the VCO group and 38 participants into the control group. Significantly fewer participants in the VCO group had abnormal CRP levels at the end of treatment compared to control. (relative risk [RR] 0.75, 95% confidence interval [CI] 0.58 to 0.95; p=0.02) No significant difference was found in the duration of hospital stay (mean 9.33 days for VCO vs. 10.29 days for control; p=0.45) and time to symptom resolution (mean 6.8 days for VCO, vs. 6.74 days for control; p=0.91). Although the proportion of patients who developed the secondary outcomes of mortality, need for ICU admission, need for invasive ventilation, and negative viral conversion was lower in the VCO group, results did not reach statistical significance. The VCO group had larger reduction in the inflammatory markers ferritin, lactate dehydrogenase, TNF-alpha, IP-10 and IL-6, but results did not reach statistical significance. Adverse events were significantly higher in the VCO group (RR 4.87, 95% CI 1.14 to 20.79; p=0.03). Conclusion This clinical trial on hospitalized patients showed significant benefit in CRP levels of participants given VCO compared to control. There was no significant benefit in the use of VCO as adjunctive therapy in reducing duration of hospital stay. Larger studies are needed to conclusively demonstrate the effect of VCO on other clinical outcomes and inflammatory markers.
COVID-19 ; Clinical Trial

This paper provides the summaries on nine (9) important and clinically relevant publications in the field of uveitis. The first is on the standardization of uveitis nomenclature, more popularly known by its acronym - SUN, which was a result of an international workshop participated by uveitis experts in 2004. Five (5) papers were large, multicenter, clinical trials that demonstrated safety and efficacy of two (2) corticosteroids delivery devices (dexamethasone implant [Ozurdex] and fluocinolone acetonide implant [RetisertTM]) and one (1) immunomodulatory drug (adalimumab). The POINT trial compared various delivery approaches when using corticosteroids for the treatment of uveitic macular edema. The FAST trial compared two (2) durable and commonly-prescribed steroidsparing immunosuppressants, methotrexate and mycophenolate mofetil, for the treatment of non-infectious uveitis. Lastly, the SITE study, which was a large retrospective cohort study, determined the risks of overall and malignancy-related deaths among patients with inflammatory eye diseases receiving systemic immunosuppressants. Findings of these studies provide basis and rationale for the care and management of patients with uveitis and lay the groundwork for future research.
Uveitis ; Clinical Trial ; Review ; Adrenal Cortex Hormones

clinical trial. At the final phase of the trial, we invited 698 potentially-involved care providers in the survey regarding their willingness to use 2-mSv CT. Multivariable logistic regression analyses were performed to identify factors associated with willingness. Nine months after the completion of the trial patient recruitment, we surveyed whether the hospitals were using 2-mSv CT in usual practice.RESULTS: The analyses included responses from 579 participants (203 attendings and 376 trainees; 221 radiologists, 196 emergency physicians, and 162 surgeons). Regarding the willingness to immediately change their standard practice to 2-mSv CT, 158 (27.3%), 375 (64.8%), and 46 (7.9%) participants responded as “yes” (consistently), “partly” (selectively), and “no”, respectively. Willingness varied considerably across the hospitals, but only slightly across the participants' departments or job titles. Willingness was significantly associated with attendings (p = 0.004), intention to maintain the dedicated appendiceal CT protocol (p < 0.001), belief in compelling evidence on the carcinogenic risk of conventional-dose CT radiation (p = 0.028), and hospitals having more than 1000 beds (p = 0.031). Fourteen of the 20 hospitals kept using 2-mSv appendiceal CT in usual practice after the trial.CONCLUSION: Despite the extensive efforts over the years of this clinical trial, many care providers were willing to use 2-mSv CT selectively or not willing to use.]]>
Adolescent ; Appendicitis ; Emergencies ; Humans ; Intention ; Logistic Models ; Patient Selection ; Pragmatic Clinical Trial ; Prospective Studies ; Radiation Dosage ; Surgeons ; Surveys and Questionnaires ; Young Adult

Guidance and reference are provided for protocol designer. The classification of laser medical devices are introduced. The key points such as the selection of control group, evaluation indicators and method, criteria of inclusion and exclusion, and application of blinded, etc. are discussed, and the importance of management of defects in medical device is emphasized.
Clinical Trial Protocols as Topic ; Equipment and Supplies ; Lasers ; Research Design

To analyze the registered clinical trial protocols of traditional Chinese medicine(TCM) for the prevention and treatment of coronavirus disease 2019(COVID-19), in order to provide information for improving the quality of research design. The website of the Chinese Clinical Trial Registry(www.chictr.org.cn) and the American Clinical Trial Registry(clinicaltrials.gov) were searched to collect protocols of TCM for COVID-19. Documents were screened following the inclusion criteria, and data were extracted in regard to registration date, study objective, type of design, sponsor, patient, sample size, intervention, and evaluation index. Descriptive analysis was conducted. A total of 49 clinical trial protocols of TCM for COVID-19 were included. Primary sponsors were mainly hospitals or universities in places like Hubei, Beijing, Zhejiang and other regions. The implementation units are mainly in Hubei, Guangdong, Zhejiang, Henan and other regional hospitals. The types of study design were mainly experimental studies(40), including 30 randomized parallel controlled trials, 7 non-randomized controlled trials, 2 single arm trials and 1 consecutively recruited trial; besides, there were also 6 observational studies, 2 health service studies and 1 preventive study. The sample size reached a total of 30 562 cases, with a maximum of 20 000 for a single study and a minimum of 30. The 49 trials subjects included healthy people(3), isolation and observation cases(1), suspected cases(10),confirmed COVID-19 patients(31) and COVID-19 recovery patients(4). Of the 31 trials planned to include confirmed COVID-19 patients, 16 protocols no definite disease classification, 3 with a clear exclusion of severe subjects, 4 with common subjects, 2 with light, common or severe subjects, 1 with light and common subjects, 1 with common or severe subjects, 3 with severe subjects, and 1 with severe or critical subjects. The experimental interventions included Chinese patent medicine(Lianhua Qingwen Capsules/Granules, Huoxiang Zhengqi Dropping Pills/Oral Liquid, Babao Dan, Gubiao Jiedu Ling, Jinhao Jiere Granules, Compound Yu-xingcao Mixture, Jinye Baidu Granules, Shufeng Jiedu Capsuless, Shuanghuanglian Oral Liquid, Tanreqing Injection, Xuebijing Injection, Reduning Injection, Xiyanping Injection), Chinese medicinal decoction and taichi. The primary evaluation outcomes mainly included antipyretic time, clinical symptom relief, novel coronavirus nucleic acid turning to negative, conversion rate of severe cases and chest CT. There was a quick response of clinical research on the prevention and treatment of COVID-19 with TCM, with the current registered protocols covers the whole process of disease prevention, treatment and rehabilitation. However, issues need to be concerned, including unclear definition of patient's condition, unclear research objectives, unclear intervention process and inappropriate outcomes, etc. In addition, researchers should consider the actual difficulties and workload of doctors in epidemic response environment, and make effort to optimize the process and improve the operability of research protocols under the principle of medical ethics.
Betacoronavirus ; COVID-19 ; China ; Clinical Trial Protocols as Topic ; Coronavirus Infections/drug therapy* ; Drugs, Chinese Herbal/therapeutic use* ; Humans ; Medicine, Chinese Traditional ; Pandemics ; Pneumonia, Viral/drug therapy* ; Randomized Controlled Trials as Topic ; Research Design ; SARS-CoV-2 ; COVID-19 Drug Treatment

Background: Turmeric demonstrated anti-inflammatory properties in laboratory and clinical studies that suggest its usefulness in psoriasis. This is the first randomized controlled trial comparing the efficacy and safety of turmeric 1% cream to clobetasol propionate 0.05% cream in the treatment of plaque-type psoriasis. Objectives: To determine the efficacy and safety of turmeric 1% cream versus that of clobetasol propionate 0.05% cream in the treatment of plaque-type psoriasis. Methods: This was a randomized, double-blind clinical trial to determine the proportion of patients with clinical remission. Secondary outcomes namely mean PASI and pruritus scores per visit, time to remission and incidence of adverse effects were also determined. Results: Fifty-nine patients were randomized into two groups: a turmeric (n=30) and a clobetasol (n=29) group. After four weeks of treatment, there was no significant difference (p=0.36) in the proportions of patients with clinical remission in the turmeric group (5/20, 25%) and the clobetasol group (8/23, 35%) (RR 1.15, 95% CI 0.78-1.70). The average time to achieve clinical remission was 4 weeks in the turmeric group and 3.38 ± 1.06 weeks in the clobetasol group (p=0.07). There was no significant difference in post-treatment mean PASI scores in turmeric (8.77 ± 5.71) and clobetasol (7.26 ± 6.04) groups (p=0.40). Post-treatment mean pruritus scores in turmeric (6.9 ± 2.83) and clobetasol (5.83 ± 3.87) groups (p=0.30) were also statistically comparable. Two patients in the clobetasol group developed folliculitis. Conclusion Turmeric 1% cream demonstrated comparable efficacy and safety with clobetasol 0.05% cream in the treatment of mild to moderate plaque-type psoriasis.
Curcuma ; Clinical Trial

Clinical epidemiology is defined as a method for investigating the distribution and determinants of diseases and for applying this knowledge in their prevention, and simply means application of epidemiological methods for medical research. In evidence-based medicine, randomized controlled trials (RCT) are the gold standard for assessing efficacy and safety of the intervention, while it is commonly impractical because of many limitations, such as ethical/legal problems and weak external-validity. High internal-validity of RCT permits to assess the direct efficacy of intervention without interference with bias and confounder; however, it has less generalizability or applicability to the real-life practice. Evidence-based practical guidelines are developed for patient management and decision making in real-life practice; paradoxically, the evidence of the guidelines does not come from real life, but from strict trial life. To overcome these limitations, pragmatic clinical trials for assessing the effectiveness of intervention in real-life practice or high-quality observational studies would be the best alternatives or could add more strong evidence. This article provides an overview of clinicoepidemiological research designs in the field of childhood allergic diseases and their strength/weakness.
Bias (Epidemiology) ; Child ; Decision Making ; Epidemiologic Methods ; Epidemiology ; Evidence-Based Medicine ; Humans ; Hypersensitivity ; Pragmatic Clinical Trial ; Pragmatic Clinical Trials as Topic ; Research Design*

PURPOSE: Adherence to immunosuppressants is the key to prevent organ rejection in organ transplant recipients. The purpose of this study was to investigate current interventions to improve adherence to immunosuppressants in liver transplant recipients. METHODS: A systemic literature search was done using PubMed, Embase, Cochrane Library, CINAHL and four Korean databases to identify experimental studies reported in English or Korean up to and including 2015. We identified eight intervention studies on the adherence to immunosuppressants in liver transplant recipients independently reviewed by two reviewers. The quality and risk of bias of the selected studies were assessed. RESULTS: Education, conversion of regimen, and text messaging were identified as intervention techniques to improve adherence. We found positive results in three out of four studies implementing educational strategies, but the results were not sufficient to draw a definite conclusion. Conversion from a twice-daily tacrolimus-based regimen to a once-daily tacrolimus extended-release formula was used in three adult-only studies and its effectiveness was confirmed. One study showed that improved adherence and outcomes were effected by using text messaging with pediatric patients. CONCLUSION: Future research is needed to facilitate interventions to improve adherence to immunosuppressants in various ages of patients including pediatric/adolescent liver transplant recipients.
Bias (Epidemiology) ; Education ; Humans ; Immunosuppressive Agents* ; Clinical Trial ; Liver* ; Tacrolimus ; Text Messaging ; Transplantation* ; Transplants

PURPOSE: This study was conducted to identify the factors affecting container terminal worker's recovery experience from job stress. METHODS: The subjects were 299 workers from one S dock in P city. Data were collected from April 5 to June 5, 2015 and analyzed by SPSS/WIN 18.0 program using descriptive statistics, t-test, ANOVA, Sheffe test, Pearson's correlation coefficients, and logistic regression. RESULTS: The mean scores of job stress, ego-resilience, and recovery experience from job stress were 47.18, 46.90, and 49.17 respectively. Recovery experience according to the general characteristics showed significant correlation between daily exercise. There was a significant negative correlation between recovery experience and job stress, and a positive correlation between recovery experience and ego-resilience. Recovery experience was 2.54 times higher for a high ego-resilience group than for a low ego-resilience group, and the group that exercised was 2.25 times higher, than the non-exercising group. The group with a low level of interpersonal conflict was 1.97 times higher, than a group with a high level of interpersonal conflict. CONCLUSION: Based on this study, intervention programs to increase ego-resilience, decrease interpersonal conflict, and encourage over 30-minute-daily exercise for in container terminal workers should be developed to improve recovery experience of job stress.
Clinical Trial ; Logistic Models ; Recovery of Function