Clinical R&D Flashcards
These aim to collect, summarize and describe.
a) inferential stats
b) descriptive stats
b) descriptive stats
These allow conclusions about a larger population from a smaller study sample.
a) inferential stats
b) descriptive stats
a) inferential stats
This states that there is no difference between two groups
null hypothesis
a hypothesis which rejects an experimental hypothesis. It is the status quo.
null hypothesis
the average:
a) mean
b) median
c) mode
a) mean
the middle response in a sequence from lowest to highest
a) mean
b) median
c) mode
b) median
where there is an even number of scores, take an average of the middle scores to get this:
a) mean
b) median
c) mode
b) median
this is the best way to measure central tendency where there are extreme outliers
a) mean
b) median
c) mode
b) median
the most frequent score in a population of scores a) mean
b) median
c) mode
c) mode
these are measures of central tendency
mean
median
mode
these are measures of spread
range
interquartile range
standard deviation
This shows a tendency of spread from smallest to highest values; variability
a) range
b) interquartile range
c) standard deviation
a) range
this measure of spread shows the middle 50%
a) range
b) interquartile range
c) standard deviation
b) interquartile range (how many scores fall between 25-75%. It is less sensitive to extremes)
this measure allows you to infer results outside of your sample, if taken to at least 3 levels
a) range
b) interquartile range
c) standard deviation
c) standard deviation
T/F: if a P-value is less than 5%, a real difference exists
True
T/F: with a P-value of 0.1%, a real difference exists
False
This measures how likely the observed results are due to chance/random error
P-value
What are 3 factors that influence P-value?
magnitude of effect
sample size
variability
T/F: a larger sample increases the statistical power of a study
true
T/F: a lower magnitude increases the statistical power of a study
false
T/F: a lower variability increases the statistical power of a study
true
limits responses to categories, usually a choice of two (ex: yes/no, gender, age, occupation, height)
a) categorical
b) continuous
a) categorical
limits responses to a given range, usually a 0-10 scale (ex: blood pressure)
a) categorical
b) continuous
b) continuous
T/F: the lower the p-value, the more confidently we can reject the null hypothesis
true
T/F: p-value has to do with clinical significance
false: p-value determines statistical significance
what power variable is typically used in healthcare to determine if a difference does actually exist?
.80 = this means a study has an 80% chance of finding a statistically significant result (a p-value of less than 5%)
what group size is typically used per tx group to determine the power of a study?
40-50
this measures if the size of the result was large enough. If it is large, there is more statistical power.
magnitude of effect
this is the ratio of probability of an event occurring in an exposed group vs. the event occurring in comparison to a non-exposed group
relative risk
this measures levels of uncertainty
confidence intervals
T/F: a narrow confidence interval means a study is inadequately powered
F: a narrow confidence interval is well-powered
this indx how much your observed sample statistic may fluctuate if the same experiment is repeated a large number of times in the same sample
a) standard error
b) confidence interval
a) standard error
this indx the range that’s likely to contain the true population parameter
a) standard error
b) confidence interval
b) confidence interval
_______focuses on sample while ________focuses on population.
a) confidence interval/standard error
b) standard error/confidence interval
b) standard error/confidence interval
this type of stat helps determine if study results are affected by random error:
a) inferential stats
b) descriptive stats
a) inferential stats
in the example “56% of polled residents would vote in favor of the amendment +/-5%”, which part is the descriptive statistic?
56%
in the example “56% of polled residents would vote in favor of the amendment +/-5%”, which part is the inferential statistic?
+/- 5%
T/F: a small interquartile range means most of the data fell close to the median, this limits variability
T
this is often described as the average distance from the mean
standard deviation
Culture, personal values, previous experience with other healthcare providers/settings, expectations, preferences, ability to pay for healthcare, health history, symptoms and physical signs are examples of this category of EIP.
Patient’s presentation
This category of EIP aims to determine the cause of disease or condition, how a disease or condition can be prevented, how can good health be maintained, how can we diagnose disease, how common is a disease, does it occur more in certain populations than other, what are effective treatments for a disease, how do these treatments work, are some more appropriate for certain patients, what are adverse effects of a treatment, etc.
Research evidence
This piece of EIP is intuitive and implicit and cannot be measured. It involves the experience of the clinician and/or the collective experience of the profession.
Clinical experience
name the 3 pillars of EIP
Clinical experience
Research evidence
Patient experience
type of research appraised by statistics to develop standards based on “statistical patient”
Quantitative
Research based on feedback/perceptions (e.g.: what do patient’s think about their tx?) Includes focus groups, video tapes of behaviors, interviews.
Qualitative
scientific investigation aimed at generating new knowledge to help diagnose, treat, and prevent disease. It involves the systematic study of tests and treatments to determine their safety and effectiveness. This type of research is performed on human subjects.
clinical research
Type of research that observes and measures people in real-world settings. It is distinguished from experimental research, where researchers control or manipulate what is done to people and then examine the effects. This type of research answers important questions about the causes of health and disease in the real world.
observational research
Case reports, case control studies and cohort studies are examples of this type of research
Observational research
this type of research measures how common a disease is in a given population or what the association is between an exposure and an effect
observational research (can NOT determine cause & effect)
an observation of a series of individuals or their medical records without a control group is called this
case series
a snapshot of a specific population’s health and behaviors at one point in time is called this
cross-sectional study
compares cases who have developed an outcome of interest to those without the outcome of interest to see if there were differences in exposure
case control (unlike a cohort, participants have NOT developed the outcome of interest yet.)
what is the main difference between a randomized controlled study and a randomized clinical study/trial?
Random clinical trials usually have another type of tx as a comparison group where random controlled studies usually have placebo or sham tx as comparison group
these are generally used to determine the effectiveness of a tx
RCTs
what 2 key characteristics differentiate RCT from other types of clinical research?
- experimental in nature
2. assignment to treatment or exposure is done via randomization and concealed application
This type of research examines the causes and mechanisms by which treatment and diagnostic tests may work. Includes work done in labs on cells, animal models & human tissues
basic science research
what are the 4 basic characteristics for basic science research that separate it from other types of research?
- setting - lab or controlled environ
- subjects - cells, rodents, animals, human body parts or live humans
- outcomes - disease oriented such as cell counts/changes, biomarkers, etc
- Answers: How does X work; is X possible?
what are the 2 main limitations of basic science research
- can’t be directly applied to patients
2. may produce unanticipated results in humans
what part of the evidence pyramid is most valid and why
summary research, because it’s critically appraised
what is the usefulness equation?
relevance x validity / work
What does PICO stand for?
Patient/problem
Intervention
Control
Outcome
Subjective or objective?
Described by the patient and includes their preferences
Subjective
Subjective or objective?
measured by observation/exam results
Objective
what are the 5 kinds of observational research?
- case reports
- case series
- case control studies
- cohort studies
- cross sectional studies
he percent likelihood that a random sample of the data will fall within a specific range of values.
confidence interval
studies how social factors, financing systems, organizational processes, and health technologies affect access, quality, and cost of healthcare. It looks at the impact on the individual, organizational, community and population levels.
health services research
the indicator of a study’s ability to measure what is intended. In other words, was the study design rigorous enough to have confidence that the researchers actually found what they think they found? Answers the questions, “How well was the study done? Do the results reflect the truth?”
internal validity
a type of systematic review that uses statistical methods to combine the results of several original studies. Like all systematic reviews, meta-analyses attempt to find all available studies on a specific topic and critically appraise them. They commonly answer one question, such as “is treatment X effective for condition Y?”
meta analysis
These address specific questions or broad topics. Unlike other types of summary research (such as systematic reviews) these don’t include all available studies. They also tend to be unfiltered, that is, they don’t critically appraise the studies they include. This makes them susceptible to bias.
narrative review
how many people we need to treat with a therapy for one additional person to benefit.
Number needed to treat
this type of research refers to individual research studies. These include types of clinical research (i.e., randomized clinical trials) and observational research (i.e., cohort studies, case-control studies, etc.).
original research
the ability of a study to find the difference between groups if a difference really exists. It depends on the number of patients and the magnitude of the difference.
Power
the probability that a particular result might have happened by chance.
p-value
compares the probability of either harm or benefit of one treatment as compared with another. For example a value of 0.7 tells us that the likelihood of something happening is 30% lower in one group versus the other.
relative risk
synthesizes all of the studies on a given topic and critically appraises it. Examples include systematic reviews, meta-analyses and guidelines. When done well, this type of research is the most useful type of research evidence for clinicians to use.
summary research
a summary and filtered resource. It locates all the available studies about treatment for a particular condition and critically appraises them. This provides a summary of the existing research evidence regarding treatment’s effectiveness.
systematic review
T or F? Meta-analyses use numerical methods (statistical analysis) to combine the results of several original studies. This is sometimes called “pooling” or a “quantitative synthesis.”
True
T or F? Systematic reviews don’t use numerical methods to combine the results. Instead, they simply summarize the studies, which is why they are sometimes called a “qualitative synthesis.”
True
A white paper is an example of this.
Narrative review
which of the 6 A’s is represented by:
identifying what you want to know. Your question could concern a patient’s prognosis, the effectiveness or risks of a treatment or a diagnostic test, etc.
It is important for you to understand the situation and the gaps in your knowledge, so you know what information you need to search for.
analyze
which of the 6 A’s is represented by:
formulate your question in such a way that you can effectively search for answers. Be specific about what you want to know. Your questions should be focused and searchable. use PICO: Patient, Intervention, Comparison, and Outcome.
Ask
which of the 6 A’s is represented by: choose related keywords to do a search in PubMed.
acquire
which of the 6 A’s is represented by: assess the relevance and quality of the research you find. One way to do this is to use worksheets that walk you through a series of questions about the research.
appraise
which of the 6 A’s is represented by: Consider the patient’s presentation, your clinical experience, and the research evidence. Does the research evidence support the effectiveness of the treatment (or test) you are considering?
Also consider whether or not the benefits of the treatment (or test) outweigh the risks. Are they congruent with the patient’s preferences? What are the costs?
apply
which of the 6 A’s is represented by: Evaluate whether or not the treatment (or test) you chose to use is working. If you are assessing a treatment, consider what outcome measurement tools you will use to monitor your patient.
assess
what are the two most commonly accepted tools to measure LBP?
Rowland Morris Questionnaire
Owestry Questionnaire
For neck pain, the most common disability measure is:
The Neck Disability Index
The most common quality of life questionnaire is:
SF 36
measures how well the study was done and if the results are true. Does the study answer the questions it was designed to?
validity
T or F:
A small standard deviation indicates that the data values are close to the mean.
T
this helps to determine whether patients generally have similar results
variability
the ability to find a difference (e.g. between treatment groups), when a real difference exists.
power
how much change in an outcome actually occurred
magnitude of effect
T or F: as the magnitude of effect gets larger, we become more confident that the results are not due to chance alone (i.e., the p-value gets smaller).
T
T or F: as the sample size (the number of people in a study) increases, the corresponding p-values for the results increase.
F: as the sample size (the number of people in a study) increases, the corresponding p-values for the results decrease.
T or F: as the variability gets smaller, we become more confident that the results are not due to chance (i.e., the p-value gets smaller)
T
what are 3 things to consider even if a study has a p-value of statistical significance
- Bias
- Relevance of study
- Are results of clinical importance?
The power of a study depends on the magnitude of effect and the _______.
sample size
the confidence that the observed result is not due to chance
p-value
