Ch 15 Flashcards
What are the CONSORT guidelines?
The CONSORT guidelines or the Consolidated Standards of Reporting Trials 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
Research designs can have bias from …
contamination of treatment, noncompliance bias, and attrition bias.
Contamination of treatment …
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.
Noncompliance bias is when ….
study participants are not compliant with the intervention, and a high incidence of noncompliance limits the effectiveness of the study.
Attrition bias is similar to noncompliance bias in that…
when members of a sample drop out of a study it hurts it. Remember a power analysis is done to calculate a sample size needed to internal validity. If attrition is high the sample can drop below this amount
Sampling biases include ___ and ___bias.
Sampling biases include volunteer and nonresponsive bias. Volunteer bias prevents randomization and introduces bias into a study. Some individuals do not respond to a survey due to answers that would make them differ from others. This leads to drop out or to false answers.
Measurement biases include ___ bias and ___ biases.
Measurement biases include acquiescence bias and observer biases. Acquiescence is when participants want to be in agreement and it skews the data. Observer biases are when the observer documents or records with personal bias influencing the interpretation of what is observed.
Clinical significance is ___
Clinical significance 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 statistical significance.
Clinical significance is or is not variable?
Clinical significance is variable. For one study seeing an improvement in a health outcome due to a single intervention is straight forward. For another study seeing the progression of a disease halted due to an intervention is clinically significant even if nothing specific changes. Another type is when the focus is on the patient themselves and their interpretations.
Change scores look at …
alterations in a patient baseline to a follow-up value, such as weight, glucose, etc.
For group-level studies clinical significance can be gauged with …
For group-level studies clinical significance can be gauged with effect size indexes, confidence intervals, and number needed to treat. The p value is not used for group level clinical significance.
Individual level studies require a ….
Individual level studies require a benchmark. Clinical significance is determined by a patient’s results compared to the benchmark. A benchmark is usually decided by a panel of experts.
Minimal important change is a method used to
define clinical significance.
Different methods to define clinical significance (minimal important change)
The first method is through the benchmark method.
The second is to ask what patients themselves think.
A third example is to count 0.5 SD in a measure as clinically significant. This is only useful for individual comparisons and not group-level.
What guidelines are used to track variations in a sample? A) CONSORT B) PRISMA C) JCAHO D) HCAPPS
Answer A: CONSORT
CONSORT guidelines are developed for keeping track of sample changes through a study. The other guidelines are not related to study samples.
