What does risk reduction mean?
This is where you need to consider the risk of treatment versus no treatment. In healthcare, risk refers to the probability of a bad outcome in people with the disease. Absolute risk reduction (ARR) – also called risk difference (RD) – is the most useful way of presenting research results to help your decision-making. In this example, the ARR is 8 per cent (20 per cent - 12 per cent = 8 …
What is absolute risk reduction in research?
Cardiovascular disease - also called heart disease is a class of diseases that involve the heart, the blood vessels (arteries, capillaries, and veins) or both. CDRH - (Center for Devices and ...
What is the RR of a treatment with a bad outcome?
· Clinical trial, phases: sequential stages of clinical testing, required by regulatory agencies, used in the development of medical treatments. Pre-clinical testing involves …
What are the 4 types of risk reduction?
A term used to describe the balance between the risk (such as side effects) and benefit of a therapy, procedure, or other course of action. RNA molecules are a copy of the genetic …
What is risk reduction in statistics?
Risk Reduction statistics are a group of statistics that are increasingly used in clinical practice as more practitioners use evidence-based practice as their approach to clinical care. Their use involves the recognition that all treatments are prescribed to reduce the patient's risk of an adverse outcome.
What is the difference between absolute and relative risk reduction?
– Relative risk reductions give a percentage reduction in one group compared to another. These can be misleading and over-exaggerate how helpful something is. – Absolute risk reductions give the actual difference in risk between one group and another.
What term is used for the ability of a test or technique to detect a disease when present?
Sensitivity refers to a test's ability to designate an individual with disease as positive. A highly sensitive test means that there are few false negative results, and thus fewer cases of disease are missed. The specificity of a test is its ability to designate an individual who does not have a disease as negative.
What does relative risk mean in medical terms?
(REH-luh-tiv …) A measure of the risk of a certain event happening in one group compared to the risk of the same event happening in another group. In cancer research, relative risk is used in prospective (forward looking) studies, such as cohort studies and clinical trials.
What is absolute risk reduction in research?
The absolute risk reduction is the arithmetic difference between the event rates in the two groups. This varies depending on the underlying event rate, becoming smaller when the event rate is low, and larger when the event rate is high.
What is difference between relative and absolute?
Summary: 1. Relative is always in proportion to a whole. Absolute is the total of all existence.
What is sensitivity and specificity in research?
Sensitivity: the ability of a test to correctly identify patients with a disease. Specificity: the ability of a test to correctly identify people without the disease. True positive: the person has the disease and the test is positive. True negative: the person does not have the disease and the test is negative.
What is good sensitivity and specificity?
For a test to be useful, sensitivity+specificity should be at least 1.5 (halfway between 1, which is useless, and 2, which is perfect). Prevalence critically affects predictive values. The lower the pretest probability of a condition, the lower the predictive values.
What is a specificity test?
Specificity measures a test's ability to correctly generate a negative result for people who don't have the condition that's being tested for (also known as the “true negative” rate).
Is relative risk the same as relative risk reduction?
Sometimes the outcome is a good one and the interpretation of relative risk is the opposite of what we have just outlined. Relative risk reduction (RRR) tells you by how much the treatment reduced the risk of bad outcomes relative to the control group who did not have the treatment.
How is absolute risk reduction calculated?
Absolute Risk Reduction = |EER-CER| ARR is the difference in the event rate between treatment group and control groups.
How do you describe relative risk?
Relative risk is a ratio of the probability of an event occurring in the exposed group versus the probability of the event occurring in the non-exposed group.
What is relative risk reduction?
Relative risk reduction(RRR) tells you by how much the treatment reduced the risk of bad outcomes relative to the control group who did not have the treatment. In the previous example, the relative risk reduction of fever and rash in the group of the children on the interventionwas 40 per cent (1 – 0.6 = 0.4 or 40 per cent).
How do you interpret the results of a randomised controlled trial?
How do you interpret the results of a randomised controlled trial? A common measure of a treatment is to look at the frequency of bad outcomes of a disease in the group being treated compared with those who were not treated. For instance, supposing that a well-designed randomised controlled trial in children with a particular disease found that 20 per cent of the control group developed bad outcomes, compared with only 12 per cent of those receiving treatment. Should you agree to give this treatment to your child? Without knowing more about the adverse effects of the therapy, it appears to reduce some of the bad outcomes of the disease. But is its effect meaningful?
What happens when the RR is less than 1?
When a treatment has an RRgreater than 1, the riskof a bad outcomeis increased by the treatment; when the RR is less than 1, the risk of a bad outcome is decreased , meaning that the treatment is likely to do good. For example, when the RR is 2.0 the chance of a bad outcome is twice as likely to occur with the treatment as without it, whereas an RR of 0.5 means that the chance of a bad outcome is twice as likely to occur without the intervention. When the RR is exactly 1, the risk is unchanged. For example, a report may state ‘The relative risk of blindness in people given drug T was 1.5’. This shows that the drug increased the risk of blindness. Another measure that is used is the odds ratio. For practical purposes, assume that the odds ratio is the same as the relative risk. Sometimes the outcome is a good one and the interpretation of relative risk is the opposite of what we have just outlined.
What is the ARR in research?
Absolute riskreduction (ARR) – also called risk difference (RD) – is the most useful way of presenting research results to help your decision-making. In this example, the ARR is 8 per cent (20 per cent - 12 per cent = 8 per cent). This means that, if 100 children were treated, 8 would be prevented from developing bad outcomes. Another way of expressing this is the number needed to treat(NNT). If 8 children out of 100 benefit from treatment, the NNT for one child to benefit is about 13 (100 ÷ 8 = 12.5).
What is the RR of a group given intervention?
For technical reasons, some other measures are often used. The relative risk(RR) of a bad outcomein a group given interventionis a proportional measure estimating the size of the effect of a treatment compared with other interventions or no treatment at all. It is the proportion of bad outcomes in the intervention group divided by the proportion of bad outcomes in the control group. In this hypothetical case, the RR is 0.6 (12 per cent ÷ 20 per cent = 0.6).
Is the RRR the same as the ARR?
The RR(and therefore the RRR) is often the same in people irrespective of their level of risk, which means that the ARR will be greatest in those at greatest risk, as shown in Table 18.1. The greater your risk, the more you stand to gain from the intervention.
What is an experiment in the FDA?
Experiment - A study done to answer a question. Other words to describe an experiment are “research,” “study,” and “protocol.”.
What is a drug reaction?
Adverse Event - drug reaction is also known as a side effect, is any undesirable experience associated with the use of a medicine in a patient. Adverse events can range from mild to severe. Serious adverse events are those that can cause disability, are life-threatening, result in hospitalization or death, or are birth defects.
What is early communication with FDA?
Early Communication about an Ongoing Safety Review - This type of communication is part of FDA’s effort to communicate early with the public when the agency is still evaluating data and has not reached a conclusion. FDA shares information in the interest of informing doctors and patients about the issues that are under review and when FDA experts anticipate completing their review.
What is a Class I recall?
Class I recalls are the most serious and involve situations where there is a reasonable probability that the use of or exposure to a volatile product, will cause serious adverse health consequences or death.
What is a drug@FDA?
Drugs@FDA - Drugs@FDA is a resource allows you to search for information about FDA approved brand name and generic drugs and therapeutic biological products . These are proteins derived from living material (such as cells or tissues) used to treat or cure disease. You can search in many ways, including by drug name and active ingredient.
What is ClinicalTrials.gov?
ClinicalTrials.Gov - is an online registry of clinical trials that are being conducted around the world. ClinicalTrials.gov is operated by the National Library of Medicine at the National Institutes of Health and can be accessed by anyone who has access to the internet.
What is DailyMed?
DailyMed - Developed with the National Library of Medicine, DailyMed is a Web site that gives physicians and patients electronic access to FDA-approved drug labels. Diabetes - is a disease in which blood glucose levels are above normal.
What is a clinical trial?
Clinical trial: an experiment designed to test the safety or efficacy of a type of therapy (such as a drug). Clinical trial, active controlled: a clinical trial in which the control group receives a treatment known to be effective. The goal of the trial is to compare different treatments.
What is the study of ethical, social, or legal issues arising in biomedicine and biomedical research?
Bioethics: the study of ethical, social, or legal issues arising in biomedicine and biomedical research.
What is clinical trial registration?
Clinical trial, registration: providing information about a clinical trial in a public registry. Most journals and funding agencies require that clinical trials be registered. Registration information includes the name of the trial, the sponsor, study design and methods, population, inclusion/exclusion criteria, and outcome measures.
What is a placebo controlled trial?
Clinical trial, placebo controlled: a clinical trial in which the control group receives a placebo. The goal of the trial is to compare a treatment to a placebo.
What is the term for failing to cite important work in the field in a paper, book, or presentation?
Citation amnesia: failing to cite important work in the field in a paper, book, or presentation.
What is bias in science?
Bias: the tendency for research results to reflect the scientist’s (or sponsor's) subjective opinions, unproven assumptions, political views, or personal or financial interests, rather than the truth or facts. See also Conflict of Interest.
What is the ethical obligation to do good and avoid causing harm?
Beneficence: the ethical obligation to do good and avoid causing harm. See also Belmont Report.
What is experimental drug use?
Experimental Drug Use. Experimental drug use is the first stage of substances use. It is the time when a person will begin to explore what drugs are, what reaction they have to them and also the social aspects of drug use. This curiosity is usually relatively safe.
Why are drugs called research chemicals?
These drugs are described as research chemicals because they are new substances that have very little information about them regarding their effects. Toxicity is often unknown and information about the experience these drugs give a user are usually based on small human studies.
What are high risk research chemicals?
High Risk Research Chemicals. Experimental drug use is usually limited to drugs such as marijuana, ecstasy, amphetamines, psychedelic drugs and more recently, research chemicals. Although the dangers of other drugs are well known, research chemicals pose many unknown risks especially when taken in combination with other drugs or alcohol.
What are the consequences of experimentation?
Impeding brain development, unwanted pregnancy, social anxieties and health problems can all be the result of experimentation that turns out badly. Additionally, the risk of developing serious substance addiction can lead to long term health problems and family dysfunction.
Why do teens use experimental drugs?
Teenagers and young adults will typically participate in experimental drug use as a way to fit in with other people, develop their social group and to see what the fuss is all about. This experimentation can be harmless, but it can also lead to long lasting consequences.
What is the first stage of substance use?
Risk Minimization. Experimental drug use is the first stage of substances use. It is the time when a person will begin to explore what drugs are, what reaction they have to them and also the social aspects of drug use. This curiosity is usually relatively safe.
Why is it dangerous to experiment with drugs?
Dangers arise through experimenting with drugs when individuals combine substances, go on drug binges or engage in high risk activities such as unsafe sex.
What is absolute risk reduction?
Absolute risk reduction, also termed risk difference, is the difference between the absolute risk of an event in the intervention group and the absolute risk in the control group.
What does a relative risk of 1.0 mean?
A relative risk of 1.0 indicates no difference between comparison groups.
What is a Hazard Ratio?
Hazard ratio is a measure of relative risk over time in circumstances where we are interested not only in the total number of events, but in their timing as well. The event of interest may be death or it may be a non-fatal event such as readmission or symptom change.
What is relative risk?
Relative risk, also known as risk ratio, is the risk of an event in the experimental group divided by that in the control group. For the sheepskin trial, this can be calculated from the data in Table 1 .
How to appreciate clinical trial results?
To appreciate the significance of clinical trial results, clinicians need to understand the mathematical language used to describe treatment effects. When comparing intervention and control groups in a trial, results may be reported in terms of relative or absolute risk (or probability), or as more statistically sophisticated entities based on odds ...
What is statistical significance?
Statistical significance is defined arbitrarily in terms of a p value of less than 0.05. The p value however does not directly indicate the chance of an effect being present or not being present. Instead it tells us how often chance alone would give apparently favourable results. A p value of less than 0.05 tells us that there is less than 5% probability that chance alone would lead to such favourable results, but it says nothing directly about whether chance is the best explanation for the results.
What is risk reduction?
Risk reduction is a collection of techniques for eliminating risk exposures. It is typically applied to lower risk probabilities and impacts to suit the risk tolerance of an individual or organization. Generally speaking, there are four ways to reduce risk:
How to reduce risk?
Finding ways to reduce risks by pooling resources with others. For example, a group of companies may reduce the risk of losing key executives by planning to transfer resources on a temporary basis in the case of an unexpected loss. Reducing risk exposures by avoiding, mitigating, transferring or sharing risks.
What is risk avoidance?
Avoiding an activity or position that may cause risk. For example, a business may decide that a new product strategy is too risky to pursue.
Which is better, the lower stage or the prognosis?
In general, the lower the stage of the tumor, the better the prognosis.
Which type of cancer is more likely to recur?
High grade: This type of cancer is more likely to recur and grow.