Chapter 15: Quantitative Research-Interpretation & Clinical Significance

Question 1

What does the following question pertain to?

“Does the actual study sample reflect the intended sample?”

Answer 1

Participant Variation
In research, there are issues with the actual sample that participated in a study being different from the intended sample.

Question 2

Walter’s example of Participation Variation:

Answer 2

If a study sought to examine the effect of nursing school on stress, it would aim to represent all nursing students.

However, what if only half the nursing schools in the area allowed the researchers to contact their students?
The sample would be limited to those available schools.

What if out of the students recruited from those schools only half of the total number responded?
The study sample would end up being much different from the general population of nursing students and it could indicate the results are not accurate.

Question 3

Participation Variation:
The _______ guidelines is used by journals to use a systematic way to track journal participants. Without the guidelines, it is harder to determine who is in the final sample to judge if they are representative.

Answer 3

CONSORT

Consolidated Standards of Reporting Trials

Question 4

Bias in Quantitative Studies is seen in which sections of study design? (4)

Answer 4

1) Research Design
2) Sampling
3) Measurement
4) Analysis

Question 5

Bias in Quantitative Studies: Research Design

What are the 3 Types of bias related to the study’s research design?

Answer 5

1) Contamination of Treatment bias
2) Noncompliance bias
3) Attrition bias

Question 6

Bias in Quantitative Studies: Research Design
________ bias is when study participants are not compliant with the intervention, and a high incidence of this limits the effectiveness of the study.

Answer 6

Noncompliance

Question 7

Bias in Quantitative Studies: Research Design
______ bias is similar in that when members of a sample drop out of a study, it hurts the study.

Remember, a power analysis is done to calculate a sample size needed for _____ (external/internal?) validity.
If this is high, the sample can drop below this amount.

Answer 7

Attrition

Internal validity

Question 8

Bias in Quantitative Studies: Research Design
___________ can represent several things. One example is if a study was to measure pain control, and some patients received an intervention that helped with pain that was not part of the study.

Answer 8

Contamination of treatment

Question 9

Bias in Quantitative Studies: Sampling

What are the 2 Types of bias related to sampling?

Answer 9

1) Volunteer bias

2) nonresponsive bias

Question 10

Bias in Quantitative Studies: Sampling
________ bias occurs when some participants don’t respond to a survey due to answers that would make them differ from others. This leads to dropout or to false answers.

Answer 10

Nonresponsive bias

Question 11

Bias in Quantitative Studies: Sampling

_______ bias prevents randomization and introduces bias into a study.

Answer 11

Volunteer bias

Question 12

Bias in Quantitative Studies: Measurement

What are the 2 Types of bias related to measurement?

Answer 12

1) Acquiescence bias

2) Observer biases.

Question 13

Bias in Quantitative Studies: Measurement

_______ bias is when participants want to be in agreement and it skews the data.

Answer 13

Acquiescence

Question 14

Bias in Quantitative Studies: Measurement
______ bias is when the observer documents or records with personal bias, influencing the interpretation of what is observed.

Answer 14

Observer

Question 15

Bias in Quantitative Studies: Analysis

What are the 2 Types of bias related to analysis?

Answer 15

1) Type I errors

2) Type II errors

Question 16

Bias in Quantitative Studies: Analysis

______ errors is when the null hypothesis is rejected when it shouldn’t be.

Answer 16

Type I errors

Question 17

Bias in Quantitative Studies: Analysis

_______ errors is when the null hypothesis is accepted when it shouldn’t be.

Answer 17

Type II errors

Question 18

_______ ________ is the practical importance of research results in terms of whether they have genuine, palpable effects on the daily lives of patients, or on the health care decisions made on their behalf.

It is not the same as what?

Answer 18

Clinical significance

NOT the same as Statistical significance.

Question 19

Clinical significance is evaluated based on:

Answer 19

1) Change scores
2) Group-level study
3) Individual-level study

Question 20

Clinical significance:

Describe what Change Scores are and how they might be used:

Answer 20

Change scores look at alterations in a patient baseline to a follow-up value, such as weight, glucose, etc

A study where the focus is on the patient themselves and their interpretations.

Question 21

Clinical significance:

For Group-level studies, clinical significance can be gauged with _______, ________, and the __________ .

Answer 21

1) effect size index
2) confidence intervals (95%)
3) number needed to treat

Question 22

Clinical significance:

Do Group-level studies use a p value?

Answer 22

Nope, p values measure STATISTICAL significance

The p value is not used for group-level clinical significance.

Question 23

Clinical significance:
Individual-level studies require a _______, usually decided by a panel of experts.
How is Clinical significance determined with this requirement?

What other parameter can Individual-level studies utilize to define clinical significance?

Answer 23

1) Benchmark
Clinical significance is determined by a patient’s results compared to the benchmark.

2) Minimal important change

Question 24

Clinical significance: Individual-level Studies

Minimal important change can define clinical significance in 3 different ways, what are they?

Answer 24

1) The first method is through the benchmark method.
2) The second is to ask what patients themselves think.

3) A third example is to count 0.5 SD in a measure as clinically significant
(NOT the same as aiming for a 95% confidence interval)

Question 25

Clinical Signidicance:

Utilizing a 0.5 SD as a measure of clinical significance can ONLY be used in ______ (group/individual?)-level studies.

Answer 25

Only useful for INDIVIDUAL-level comparisons and not group-level.

Question 26

Clinical significance is VARIABLE:
A study seeing an IMPROVEMENT in a health outcome due to a single intervention is straightforward.

What about a study where the intervention didn’t improve a health outcome but did halt the disease progression? Is this clinically significant?

Answer 26

YES
A study seeing the progression of a disease halted due to an intervention is clinically significant, even if nothing specific changes.

Question 27

Just to reiterate:

What guidelines are used to track variations in a sample?

Answer 27

CONSORT

Question 28

Which factors are useful in determining group-level clinical significance?

Answer 28

1) Number needed to treat
2) effect size index
3) confidence intervals

Question 29

Which factor is useful in determining individual-level clinical significance?

Answer 29

Minimal important change

Question 30

What is used to calculate individual-level clinical significance?

Answer 30

Benchmarks

Question 31

3 methods to measure minimum individual change?

Answer 31

1) 0.5 SD threshold
2) Using benchmarks
3) Having patient’s rate what is significant