Efektivitas Dan Keamanan Vaksin Covid-19 : Studi Refrensi

2021 ◽  
Vol 9 (2) ◽  
pp. 61-107
Author(s):  
Setiyo Adi Nugroho ◽  
Indra Nur Hidayat
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Public Confidence ◽  
Study Approach ◽  
A Value ◽  
Study Results ◽  
Approach Method ◽  
Short And Long Term ◽  
Protective Effectiveness

Various strategies and development of the Covid-19 vaccine have been carried out for the control of the Covid-19 pandemic. Various vaccines have undergone clinical trials with promising results in various countries. The effectiveness and safety and short- and long-term side effects of vaccines are a major concern in clinical trials in these strategies and developments. Purpose: The purpose of this study is to find out the effectiveness and safety of the Covid-19 vaccine so that it can inform and increase public confidence in the Covid-19 vaccine through a reference study approach. Method: The research method we use here is a reference study using electronic databases through journals from international and national. Google Scholar, science direx, elsiver, Pubmed are used as the main Journal database for this reference study. Results: From the results of reference studies found that all vaccines in clinical trials have promising effectiveness and safety. The Pfizer-BiONTech vaccine is a vaccine that has a good level of effectiveness and safety with a value of 94.6% and does not cause serious side effects. Double-dose vaccination further improves the immune response in younger and older adults. Conclusion: The Covid-19 vaccine in clinical trials all demonstrates promising immunogenicity with varying levels of protective effectiveness and an acceptable safety profile.

scholarly journals Rationale, Design, and Methodology of a Prospective Cohort Study for Coping with Behavioral and Psychological Symptoms of Dementia: The RECage Project

2021 ◽  
Vol 80 (4) ◽  
pp. 1613-1627
Author(s):  
Eleni Poptsi ◽  
Magda Tsolaki ◽  
Sverre Bergh ◽  
Bruno Mario Cesana ◽  
Alfonso Ciccone ◽  
...  
Keyword(s):  
Cohort Study ◽  
Psychotropic Drug ◽  
Psychological Symptoms ◽  
Cost Of Care ◽  
Community Dwelling ◽  
Drug Consumption ◽  
Study Results ◽  
Short And Long Term ◽  
Behavioral And Psychological Symptoms

Background: Behavioral and psychological symptoms of dementia (BPSD) are quite challenging problems during the dementia course. Special Care Units for people with dementia (PwD) and BPSD (SCU-B) are residential medical structures, where BPSD patients are temporarily admitted, in case of unmanageable behavioral disturbances at home. Objective: RECage (REspectful Caring for AGitated Elderly) aspires to assess the short and long-term effectiveness of SCU-Bs toward alleviating BPSD and improving the quality of life (QoL) of PwD and their caregivers. Methods: RECage is a three-year, prospective study enrolling 500 PwD. Particularly, 250 community-dwelling PwDs presenting with severe BPSD will be recruited by five clinical centers across Europe, endowed with a SCU-B, for a short period of time; a second similar group of 250 PwD will be followed by six other no-SCU-B centers solely via outpatient visits. RECage’s endpoints include short and long-term SCU-B clinical efficacy, QoL of patients and caregivers, cost-effectiveness of the SCU-B, psychotropic drug consumption, caregivers’ attitude toward dementia, and time to nursing home placement. Results: PwD admitted in SCU-Bs are expected to have diminished rates of BPSD and better QoL and their caregivers are also expected to have better QoL and improved attitude towards dementia, compared to those followed in no-SCU-Bs. Also, the cost of care and the psychotropic drug consumption are expected to be lower. Finally, PwD followed in no-SCU-Bs are expected to have earlier admission to nursing homes. Conclusion: The cohort study results will refine the SCU-B model, issuing recommendations for implementation of SCU-Bs in the countries where they are scarce or non-existent.

scholarly journals Influences on Attitudes Regarding Potential COVID-19 Vaccination in the United States

Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 582 ◽  
Author(s):  
Kendall Pogue ◽  
Jamie L. Jensen ◽  
Carter K. Stancil ◽  
Daniel G. Ferguson ◽  
Savannah J. Hughes ◽  
...  
Keyword(s):  
United States ◽  
Structural Equation Modeling ◽  
Side Effects ◽  
Structural Equation ◽  
The United States ◽  
Equation Modeling ◽  
Vaccine Acceptance ◽  
The World ◽  
Short And Long Term

The COVID-19 pandemic continues to ravage the world, with the United States being highly affected. A vaccine provides the best hope for a permanent solution to controlling the pandemic. However, to be effective, a vaccine must be accepted and used by a large majority of the population. The aim of this study was to understand the attitudes towards and obstacles facing vaccination with a potential COVID-19 vaccine. To measure these attitudes a survey was administered to 316 respondents across the United States by a survey corporation. Structural equation modeling was used to analyze the relationships of several factors with attitudes toward potential COVID-19 vaccination. Prior vaccine usage and attitudes predicted attitudes towards COVID-19 vaccination. Assessment of the severity of COVID-19 for the United States was also predictive. Approximately 68% of all respondents were supportive of being vaccinated for COVID-19, but side effects, efficacy and length of testing remained concerns. Longer testing, increased efficacy and development in the United States were significantly associated with increased vaccine acceptance. Messages promoting COVID-19 vaccination should seek to alleviate the concerns of those who are already vaccine-hesitant. Messaging directed at the benefits of vaccination for the United States as a country would address the second predictive factor. Enough time should be taken to allay concerns about both short- and long-term side effects before a vaccine is released.

scholarly journals Recent advances in understanding and treating vasculitis

F1000Research ◽  
2016 ◽  
Vol 5 ◽  
pp. 1436 ◽  
Author(s):  
Matthew J. Koster ◽  
Kenneth J. Warrington
Keyword(s):  
Monoclonal Antibody ◽  
Clinical Trials ◽  
Long Term Effects ◽  
Dose Frequency ◽  
Treatment Regimens ◽  
Recent Advances ◽  
Short And Long Term ◽  
Anti Cd20 ◽  
Long Term Adverse Effects

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAVs) are near universally fatal conditions if untreated. Although effective therapeutic options are available for these diseases, treatment regimens are associated with both short- and long-term adverse effects. The recent identification of effective B-cell-targeted therapy with an anti-CD20 monoclonal antibody has transformed the treatment landscape of AAV. Questions, nevertheless, remain regarding the appropriate timing, dose, frequency, duration, and long-term effects of treatment. The aim of this article is to provide an overview of the current information, recent advances, ongoing clinical trials, and future treatment possibilities in AAV.

scholarly journals Obeticholic acid—a new therapy in PBC and NASH

2020 ◽  
Vol 133 (1) ◽  
pp. 95-104 ◽  
Author(s):  
Roger W Chapman ◽  
Kate D Lynch
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Ursodeoxycholic Acid ◽  
Farnesoid X Receptor ◽  
Primary Biliary Cholangitis ◽  
Second Line ◽  
Obeticholic Acid ◽  
Second Line Therapy ◽  
Line Therapy

Abstract Introduction Obeticholic acid (OCA) is a semi-synthetic hydrophobic bile acid (BA) analogue that is highly selective agonist of farnesoid X receptor (FXR), a key nuclear BA receptor, which induces expression of gut-derived hormones, in particular fibroblast growth factor 19. The resulting beneficial effects of OCA on glucose and lipid metabolism and particularly hepatic inflammation make it a candidate for the treatment of a variety of conditions including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Sources of data In PBC patients who have not initially responded to ursodeoxycholic acid, OCA has been shown in double-blind controlled clinical trials to significantly reduce serum alkaline phosphatase. To date, OCA is the only therapy licensed by the FDA, EMA and endorsed by NICE as second line therapy for PBC. No medications are currently approved in Europe or the USA for the treatment of NASH. In recent clinical trials, OCA has been shown encouraging results by improving liver blood tests and reducing liver fibrosis with no worsening of NASH. Areas of agreement OCA is the established second line therapy for PBC in those patients who fail to adequately respond to ursodeoxycholic acid. Areas of controversy The main side effects of OCA treatment in both PBC and NASH is that of dose-dependent pruritis which can lead to treatment discontinuation in ~1–10% of patients. In addition, OCA-treated patients may also exhibit (reversible) alterations in serum lipid levels; most notably a small decrease in high density lipoprotein cholesterol. It is not yet known whether these changes carry a long-term cardiovascular risk in NASH. In addition, the relatively high cost of OCA may limit its use in cash-limited health systems. Growing Points Additional clinical trials are in progress to ascertain the long-term effects of OCA on survival in PBC and NASH. Areas timely for developing research New FXR agonists with a lower rate of side effects are being developed and trialed. Combination therapy with other agents may offer increased efficacy.

Reconsenting patients with cancer on clinical trials: Does added risk influence continued participation?

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15610-e15610
Author(s):  
A. Elegbede ◽  
A. Andrei ◽  
A. Andrei ◽  
K. D. Holen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Event ◽  
Side Effects ◽  
Adverse Events ◽  
Study Participant ◽  
P Value ◽  
Study Participation ◽  
Grade 5 ◽  
Study Results

e15610 Background: The general policy endorsed by multiple professional societies and cooperative groups regarding patients on cancer clinical trials states that subjects should be informed of new adverse events or significant developments during study participation and re-consented to continue on study. However, no information is known as to the effect of re-consenting on a patients’ decision to continue study participation. Our research question addresses how the severity of reported risk to other study participants will impact the subjects’ decision to continue participation in a clinical trial. Methods: We surveyed 34 patients with gastrointestinal (GI) tumors all of whom were currently enrolled in a clinical trial. The survey portrayed hypothetical adverse reactions affecting another study participant ranging from Grade 1 to Grade 5 according to the National Cancer Institutes Common Terminology Criteria for Adverse Effects v. 3.0. The survey asked about subjects’ opinions of the theoretical adverse event categorized as “would not be concerned,” “would be concerned, but would continue the study,” and “would discontinue the study.” Results: Patients willingness to continue the study was highest at Grade 1 with 97% of all participants. However, willingness to continue participation progressively declined as the severity of adverse events increased such that only 44% of participants would continue participation with a reported Grade 5 adverse event. Conclusions: Among surveyed GI cancer patients, willingness to continue participation in a clinical trial declined significantly as the severity of adverse events increased from Grade 1 to Grade 3 - 5 (p-value < 0.001. This could be due to multiple factors, including the terminal nature of the patients’ cancer, the side effects of study therapy and the patients’ response to study treatment. This data could produce a reasonable adverse event grade cut-off for re-consenting patients regarding new side effects. No significant financial relationships to disclose.

Role and Relevance of Neurocognitive Assessment in Clinical Trials of Patients With CNS Tumors

2006 ◽  
Vol 24 (8) ◽  
pp. 1305-1309 ◽  
Author(s):  
Christina A. Meyers ◽  
Paul D. Brown
Keyword(s):  
Clinical Trials ◽  
Cns Tumors ◽  
Tumor Control ◽  
End Points ◽  
Treatment Regimens ◽  
Neurocognitive Assessment ◽  
Short And Long Term ◽  
Effect Of Treatment ◽  
Cognitive Problems

The inclusion of neurocognitive end points in clinical trials of patients with CNS tumors is increasing. Neurocognitive end points are used to understand what cognitive problems exist before treatment to establish a baseline by which the effect of treatment is judged, and to determine whether different treatment regimens improve neurocognitive function due to better tumor control, slow expected neurocognitive deterioration due to the tumor, or have more or less short- and long-term neurotoxicity. However, the use of neurocognitive end points in clinical trials for patients with CNS tumors is in its infancy, so that long-term outcomes are difficult to predict and the ability to determine the effects of different agents and treatment approaches is scant. Including this aspect of patient evaluation in addition to survival and time to tumor progression will yield better risk-versus-benefit assessments as well as provide a basis for improving interventions.

SPECIAL REQUIREMENTS FOR TOXICITY TESTING OF ORAL COMPOUNDS ADMINISTERED CONTINUOUSLY OR CYCLICALLY

1974 ◽  
Vol 77 (1_Suppla) ◽  
pp. S387-S408 ◽  
Author(s):  
G. A. Overbeek ◽  
H. W. Hornstra ◽  
E. B. van Julsingha ◽  
J. P. Mumford ◽  
I. Zayed
Keyword(s):  
Side Effects ◽  
Oral Contraceptives ◽  
Predictive Value ◽  
Animal Studies ◽  
Toxicity Testing ◽  
Prolonged Treatment ◽  
Safety Studies ◽  
Short And Long Term ◽  
Dose Levels

ABSTRACT The authors feel that several reasons exist for considering contraceptives as a special class of drugs, which therefore require special safety studies. Apart from the usual short and long term studies, particular attention should be paid to the reversibility of the induced infertility, and to its possible consequences for subsequent offspring. A possible risk of damage to the foetus is partially outweighed by the low risk of pregnancy during the treatment periods with oral contraceptives. The procedures used in the Organon laboratories are briefly described. Principles on which we base the choice of dose levels and the duration of the various studies are discussed. The paucity of available data from toxicity studies in animals has prevented the presentation of a summary allowing an appraisal of the predictive value of the current methods in toxicology. Nevertheless, a few examples are given which demonstrate the need for more predictive methods. The present lack of knowledge on side effects in humans after prolonged treatment with oral contraceptives has created a feeling of uneasiness. This in its turn has resulted in some excessive regulatory requirements for very long term animal studies. In our opinion, the predictive value of these studies is extremely low because of the inadequacy of the available animal models. More value can be attached to the monitoring of side effects in humans and efforts in this direction should be increased. The Organon system of monitoring the side effects of its marketed preparations is briefly described. It is not considered feasible to standardize regulatory toxicity requirements for the time being, which should not prevent us from aiming at reasonable, more generally accepted methods of study.

scholarly journals Influences on Attitudes regarding Potential COVID-19 Vaccination in the United States

2020 ◽  
Author(s):  
Kendall Pogue ◽  
Jamie Jensen ◽  
Carter Stancil ◽  
Daniel Ferguson ◽  
Savannah Hughes ◽  
...  
Keyword(s):  
United States ◽  
Side Effects ◽  
Predictive Factor ◽  
Structural Equation ◽  
The United States ◽  
Vaccine Acceptance ◽  
Equation Modelling ◽  
The World ◽  
Short And Long Term

The COVID-19 pandemic continues to ravage the world, with the United States being highly affected. A vaccine provides the best hope for a permanent solution to controlling the pandemic. However, to be effective, a vaccine must be accepted and used by a large majority of the population. Structural equation modelling was used to analyze the relationships of several factors with attitudes toward potential COVID-19 vaccination. The survey was administered to 316 respondents across the United States by a survey corporation. Prior vaccine usage and attitudes predicted attitudes towards COVID-19 vaccination. Assessment of the severity of COVID-19 for the United States was also predictive. Approximately 68% of all respondents were supportive of being vaccinated for COVID-19, but side effects, efficacy, and length of testing remained concerns. Longer testing, increased efficacy and development in the United States were significantly associated with increased vaccine acceptance. Messages promoting COVID-19 vaccination should seek to alleviate the concerns of those who are already vaccine-hesitant. Messaging directed at the benefits of vaccination for the United States as a country would address the second predictive factor. Enough time should be taken to allay concerns about both short and long-term side effects before a vaccine is released.

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