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S3- Research II > Clinical Research Design > Flashcards

Clinical Research Design Flashcards

1
Q

What is preclinical research?

A

Basic research that is performed in laboratories on animals and focuses on theory and understanding mechanisms of disease or therapies.

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2
Q

What is clinical research?

A

Applied research that is performed on human subjects and focuses on testing theories that help to find new and better ways to detect, diagnose, treat, and prevent disease or develop theories.

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3
Q

What are 5 steps of the clinical research process?

A
  1. ) Identify the research question
  2. ) Design the study
  3. ) Implement the study
  4. ) Analyze data
  5. ) Disseminate findings
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4
Q

Findings from clinical research are used for what?

A

EBP (Evidence Based Practice)

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5
Q

What is the 1st step of the clinical research process?

A

Identify the research question

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6
Q
  • Step 1 of the clinical research process is used to specify a _________ to investigate.
  • This is the most important, and often the most difficult part for what reason?
A
  • question

- Controls the direction of all subsequent planning and analysis, design and statistics included.

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7
Q

What is the 2nd step of the clinical research process?

A

Design the study

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8
Q

What are 4 questions to ask when designing a study?

A
  • Who will be studied?
  • How subjects will be chosen?
  • What to measure?
  • What statistical methods for data analysis?
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9
Q

What is the 3rd step of the clinical research process?

A

Implement the study

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10
Q

Step 3 of the clinical research process is used to implement the plans designed in steps 1 and 2 and to collect ____.

A

data

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11
Q

What is the 4th step of the clinical research process?

A

Analyze the data

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12
Q

Step 4 of the clinical research process used to analyze, interpret, and draw valid conclusions about the data obtained in step 3. It applies statistical procedures to summarize and explore _________ information in a meaningful way to address what?

A
  • quantative

- research question

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13
Q

What is the 5th step of the clinical research process?

A

Disseminate findings

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14
Q

Step 5 of the clinical research process is used to share findings with the appropriate audience so others can apply the information _________ or to further research. It is also used to pull together all the materials and apply them to a generalized/theoretical framework.

A

clinically

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15
Q

What are some examples of ways we can disseminate findings?

A
  • Journal articles
  • Abstracts
  • Oral presentations
  • Poster presentations
  • Conference proceedings
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16
Q

What are the 3 types of research?

A
  • Descriptive
  • Exploratory
  • Explanatory
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17
Q

Descriptive research can be both qualitative and ____________. It is used to describe a _______ of individuals on a set of variables. It uses questionnaires, interviews, direct observation, or the use of databases.

A
  • quantitative

- group

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18
Q

What are 2 examples of types of descriptive research?

A
  • case report studies

- descriptive studies

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19
Q

Exploratory research is observational without ___________. It is used to find ___________ between factors.

A
  • intervention

- relationships

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20
Q

What are 2 examples of types of exploratory research?

A
  • cohort studies

- case-control studies

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21
Q

Explanatory research is experimental with __________. It is used to establish _______ and _______ between interventions and outcomes.

A
  • intervention

- cause and effect

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22
Q

What is an example of a type of explanatory research?

A

RCT (randomized control trial)

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23
Q

In summary:

  • Descriptive research is used to describe ________.
  • Exploratory research is used to find ___________.
  • Explanatory is used to establish _____________.
A
  • populations
  • relationships
  • cause and effect
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24
Q

What is a case study?

A
  • A description of interesting, new, and unique cases to build a foundation for clinical science.
  • Looks at a particular case
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25
Q

What is a descriptive study?

A

Provides an overall picture of groups characteristics

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26
Q

Case study and descriptive study are examples of what type of research?

A

Descriptive

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27
Q

What is a cohort study?

A
  • Select a cohort who do not yet have the outcome of interest and follow them to see if they develop the disorder.
  • Followed over time
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28
Q

What is a case-control study?

A
  • Select cases and controls and look backward in time to determine if the groups differ with respect to their exposure histories
  • Compare cases with controls
  • Look back in time
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29
Q

Cohort study and case-control study are examples of what type of research?

A

Exploratory

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30
Q

What is a cross-sectional study?

A

Study a cohort of subjects at one point in time and draw conclusions about a population.

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31
Q

What is a longitudinal study?

A

Follow a cohort of subjects over multiple points in time performing repeated measures.

32
Q

What is a RCT study?

A
  • Assigns subjects randomly to at least 2 comparison groups
  • Provides strongest evidence for cause and effect relationship
  • Considered gold standard of true experimental designs.
33
Q

RCT is an example of what type of research?

A

Explanatory

34
Q

Summary:
-What is clinical research?

  • What are the 5 steps of the clinical research process?
  • What are the 3 types of clinical research?
  • What are 7 main clinical research designs?
A
  • Applied research conducted on human subjects focused on testing theories that help find new and better ways to detect, diagnose, treat and prevent disease or develop therapies
  • Identify the research question, Design the study, Implement the study, Analyze data, Disseminate findings
  • Descriptive, Exploratory, Explanatory
  • Case report, Descriptive, Cohort, Case-control, Cross-sectional, longitudinal, RCT
35
Q

INTRO TO BIOSTATISTICS

A

INTRO TO BIOSTATISTICS

36
Q

What are the 2 types of data?

A
  • Continuous data

- Categorical data

37
Q

Continuous data uses ______ values. What are some examples?

A
  • numeric

- age, weight, height, A1c levels, etc.

38
Q

Categorical data uses ________ values. What are some examples?

A
  • categorical

- gender, race, exposure/disease status, etc.

39
Q

A researcher collected data from a patients group for her study. She recorded the values of the outcome variables for each patient using a statistical program as in the figure below. Which of these is a categorical variable?

Gender 
Age
Height 
Weight
BMI
40
Q

Normal data distribution is ___-shaped and is very useful with the ____________ THEOREM.

A
  • bell

- CENTRAL LIMIT (as the sample size tends to infinity, the sample mean is normally distributed)

41
Q
  • What percentage of data is within 1 standard deviation?
  • What percentage of data is within 2 standard deviations?
  • What percentage of data is within 3 standard deviation?
A
  • 68%
  • 95%
  • 99.7%
42
Q

A research study of 100 patients shows
that their calcium levels range from 8.8 – 15.0 milligrams/deciliter (mg/dL), with a mean of 12.1 mg/dL. The calcium levels fall in a normal distribution, with a standard deviation of 1.0 mg/dL. Based on this study, we know that the percentage of calcium values below 10.1 is approximately

1% 
2.5%
5% 
8.5%
16%
43
Q

What are a few non-normal data distribution models?

A
  • Bimodal
  • Skewed-to-the-right
  • Skewed-to-the-left
44
Q

Bimodal is suggestive of 2 different ___________.

A

populations

45
Q

With a skewed-to-the-right distribution, what is the order or mean, median and mode from left to right?

A

mode - median - mean

46
Q

With a skewed-to-the-left distribution what is the order or mean, median, and mode from left to right?

A

mean - median - mode

47
Q

For CONTINUOUS DATA,

  • measures of central tendency: _____,_____,_____
  • measures of dispersion: _______,______________
  • graphic representation: ________,_________,______
A
  • mean, median, mode
  • variance, standard deviation
  • histogram, box plot, line graph
48
Q

Measures of central tendency:

  • What is mean?
  • What is median?
  • What is mode?
A
  • Mean = (sum of values)/(total number of values)
  • Median = the value in the middle of a ranked data
  • Mode = the value that occurs most often
49
Q

Measures of dispersion:

  • What is variance?
  • What is standard deviation?
  • What is standard error of the mean?
A

Variance = (sum of square of the deviance from the mean) divided by (total number of values - 1)
Standard deviation = square root of the Variance
Standard error of the mean = (standard deviation) divided by (the square root of the total number of values)

50
Q
  • What are the most common descriptive statistics used for continuous data?
  • What are the most common descriptive statistics used for categorical data?
A
  • mean and standard deviation

- frequency and percent

51
Q

For CATEGORICAL DATA,

  • __________
  • __________, rate, ratio: prevalence, incidence rate, relative risk, odds ratio, sensitivity, specificity
  • Graphic representation: _________,____________
A
  • frequency
  • proportion
  • pie chart, bar graph
52
Q

In the data set below, variable ‘BMI’ is recorded as being continuous. Which of the following descriptive statistics would describe the variable ‘BMI’ the best?

Frequency and proportion
Sensitivity and the specificity
Mean and the variance
Incidence rate and the relative ratio
Odds and the odds ratio
A

Mean and the variance

53
Q

In the data set below, variable ‘Gender’ is recorded as being categorical. Which of the following descriptive statistics would describe the variable ‘Gender’ the best?

Frequency and the proportion 
Sensitivity and the specificity
Mean and the variance
Incidence rate and the relative ratio
Odds and the odds ratio
A

Frequency and the proportion

54
Q

What is the purpose of inferential statistics?

A

To make inference for a population group from a sample group.

55
Q

What is a population?

What is a sample?

A
  • The complete collection to be studied

- A part of the population of interest selected for study

56
Q
  • The population group’s numerical property = _________. e.g.) population mean, population proportion
  • The sample group’s quantity from it = ________. e.g.) sample mean, sample proportion
A
  • Parameter

- Statistic

57
Q

What are the 2 ways we can do inferential statistics?

A
  • Statistical Hypothesis Testing (SHT)

- Effect Size with Confidence Interval (CI)

58
Q

Which of the following statement is TRUE regarding the sample group vs. population group in the inferential statistics?

  • A sample group is the complete collection to be studied
  • It is typically the best approach to study the population group itself directly
  • A population group is selected randomly from the sample group of the study interest
  • A statistic is defined to be a numerical property of a population group
  • A population parameter is estimated by a sample statistic
A

-A population parameter is estimated by a sample statistic

59
Q

What is the goal of a Statistical Hypothesis Testing (SHT)?

A

To make decisions about a population from a sample.

60
Q

What are the 6 procedural steps of Statistical Hypothesis Testing (SHT)?

A
  1. ) State the null hypothesis
  2. ) State the alternative hypothesis
  3. ) Select a level of significance
  4. ) Collect and summarize the sample data into a statistic
  5. ) Refer to a criterion for evaluation the sample evidence producing a quantity called p-value.
  6. ) Make a decision to reject/retain the null hypothesis based on the resulting quantity of the p-value
61
Q
  • What is null hypothesis?

- What is alternative hypothesis?

A
  • Null (H₀) = Hypothesis of no effect or no difference

- Alternative (H₁) = Hypothesis of some difference or effect

62
Q

The goal of statistical hypothesis testing is to

  1. explore your data to check the validity of it
  2. describe your data distribution
  3. calculate sample quantities to understand your data
  4. make decisions about your study population from a sample
  5. make decisions about the sample from your study population
A
  1. make decisions about your study population from a sample
63
Q

What are 3 more terms used in SHT?

A
  • Effect
  • Significance level (alpha)
  • P-value
64
Q

Effect is the difference between the _________ value and the ____________ value. The size of the actual effect is ________; use a SHT to determine it exists and estimate its size.

A
  • population
  • null hypothesis
  • unknown
65
Q

The significance level (alpha) is the standard defined by the probability of __________ a true null hypothesis (a false positive). It is set _____ the study and is most commonly seen as 0.05. Lower alpha value required _______ evidence for you to reject the null hypothesis.

A
  • rejecting
  • before
  • stronger
66
Q

The P-value quantifies how consistent your sample statistics are with the null hypothesis.

  • High p-value: your sample results are ______________ with a null hypothesis that is true.
  • Low p-value: your sample results are ______________ with a null hypothesis that is true.
A
  • consistent

- not consistent

67
Q

A medical resident decides to test the hypothesis that
people with Alzheimer’s have elevated serum sodium levels. If the alpha is set at 0.01 instead of 0.05, which of the following is the most likely result?

  1. Significant findings can be reported with less confidence
  2. Significant findings can be reported with greater confidence
A
  1. Significant findings can be reported with greater confidence
68
Q

How to Finalize a Decision in a SHT:

  • Set a significant level as being _____ the Fisher’s criterion or something else as 0.01 or 0.10
  • _______ the null hypothesis when p-value is less than 0.05
  • _________ the null hypothesis when p-value is greater than 0.05
A
  • 0.05
  • Reject
  • Fail to reject
69
Q

You have conducted a study to test a null hypothesis at significance level = 0.05, and you got the p-value of 0.021 by running a chosen statistical hypothesis test. What conclusion can you make based on the p-value with the set significance level?

  1. You reject the null hypothesis and accept the alternative hypothesis
  2. You fail to reject the null hypothesis
A
  1. You reject the null hypothesis and accept the alternative hypothesis
70
Q

You have conducted a study to test a null hypothesis at significance level = 0.01, and you got the p-value of 0.021 by running a chosen statistical hypothesis test. What conclusion can you make based on the p-value with the set significance level?

  1. You reject the null hypothesis and accept the alternative hypothesis
  2. You fail to reject the null hypothesis
A
  1. You fail to reject the null hypothesis
71
Q

Type I Error (α)= _________
(null hypothesis is incorrectly rejected)

Type II Error (β) = ___________
(null hypothesis is incorrectly not rejected)

Power (1-β) = __________

A
  • false positive
  • false negative
  • true positive
72
Q

Power goes ____ when the sample size is larger with all other conditions kept at the same level.

73
Q

You are conducting a research study and want to know
whether two different drugs are equally effective.
H0: Drug A and B are equally effective
H1: Drug B is more effective than A
Your study uses a significance level of alpha = 0.05.
The power of the test was 0.80.
If the alternative hypothesis is actually true, what is the probability that the study will show a significant difference in efficacy between the two drugs?

  1. 05
  2. 20
  3. 50
  4. 80
  5. 95
74
Q

A medical resident decides to test the hypothesis that
people with Alzheimer’s have elevated serum sodium levels. The type I error of this study was 0.078. Which does the analysis represent for this study?

  • It determines the power of a study to correctly reject the null hypothesis
  • It represents the probability of incorrectly rejecting the null hypothesis
  • It represents the probability of incorrectly retaining the null hypothesis
  • It allows a study to report significant findings with greater confidence
  • It determine the power of a study to correctly retain the null hypothesis
A

It represents the probability of incorrectly rejecting the null hypothesis

75
Q

Confidence interval (CI) quantifies the __________ in the estimates.

A

uncertainty

76
Q

CI = mean ± z*(SEM),
z=1.96, for the 95% (corresponding to α=0.05)
z=2.58, for the 99% (corresponding to α=0.01)
SEM stands for __________________

The narrower interval implies higher precision with less variability
The wider interval implies lower precision with increased coverage

A

Standard Error of the Mean

77
Q

1:08:30

S3- Research II (14 decks)

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