guidelines in evaluating the validity and applicability of a research study
TRANSCRIPT
-
7/27/2019 Guidelines in Evaluating the Validity and Applicability of a Research Study
1/3
Lecture: Guidelines in Evaluating the Validity and Applicability of a
Research study
1. What is the research design?2. What is the level of quality of the Research study according to the U.S. Preventive Services Task
Force?
3. Are the results of the study valid?a. Randomizationb. Follow-up (80% or better)c. Blinding of the clinicians, patients, research personnels (the more blinding the
better
d. Baseline similarities (established at the start of the trial)4. What are the results of the research study?5. Will the results help in caring for my patient?6. What is the Level of Recommendation according to the U.S. Preventive Services Task Force
DESIGN OF THE RESEARCH STUDY
Meta Analysis
Examines a number of valid studies on a topic and combine the results using accepted statistical
methodology as if they were from one large study.
Double blind study
A study which neither the patient nor the physician knows whether the patient is receiving the treatment
of interest or the control treatment.
Randomized controlled clinical trialsPlanned projects that study the effect of a therapy on real patients. They include methodologies that
reduce the potential for bias (randomization and blinding) and that allow for comparison between
intervention groups and control groups (no intervention).
Cohort StudiesThis study involves a large population and follow patients who have a specific condition or receive a
particular treatment over time and compare them with another group that has not been affected by the
condition or treatment being studied. Cohort studies are observational and not as reliable as randomized
controlled studies, since the two groups may differ in ways other than in the variable under study.
Case Control StudiesStudies in which patients who already have a specific condition are compared with people who do not.
They often rely on medical records and patient recall for data collection. These types of studies are often
less reliable than randomized controlled trials and cohort studies because showing a statistical
relationship does not mean than one factor necessarily caused the other.
Case series and Case reports
Collections of reports on the treatment of individual patients or a report on a single patient.
-
7/27/2019 Guidelines in Evaluating the Validity and Applicability of a Research Study
2/3
Ideas, Editorials, Opinions
Exchange of ideas-Subjective
Animal Research
Trial that involves animals as samples
Test Tube research
trial that tests a substance in a test tube
LEVEL of EVIDENCE
Level I
Evidence obtained from at least one properly designed randomized controlled trial
Level II-1
Evidence obtained from well-designed controlled trials without randomization
Level II-2
Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than
one center or research group.
Level II-3
Evidence obtained from multiple time series with or without the intervention. Dramatic results in
uncontrolled trials might also be regarded as this type of evidence.
Level III
Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expertcommittees.
LEVEL OF RECOMMENDATION
The U.S. Preventive Services Task Force (USPSTF) assigns one of five letter grades to each of its
recommendations (A, B, C, D, or I).
What the Grades Mean and Suggestions for Practice
A The USPSTF recommends the service. There is high certainty that the net
benefit is substantial. Offer or provide this service.
B The USPSTF recommends the service. There is high certainty that the net
benefit is moderate or there is moderate certainty that the net benefit is
moderate to substantial. Offer or provide this service.
C Clinicians may provide this service to selected patients depending on individual
circumstances. However, for most individuals without signs or symptoms there
is likely to be only a small benefit from this service. Offer or provide this
-
7/27/2019 Guidelines in Evaluating the Validity and Applicability of a Research Study
3/3
service only if other considerations support the offering or providing the service
in an individual patient.
D The USPSTF recommends against the service. There is moderate or high
certainty that the service has no net benefit or that the harms outweigh the
benefits. Discourage the use of this service.
I The USPSTF concludes that the current evidence is insufficient to assess the
balance of benefits and harms of the service. Evidence is lacking, of poor
quality, or conflicting, and the balance of benefits and harms cannot be
determined. Read the clinical considerations section of USPSTF
Recommendation Statement. If the service is offered, patients should
understand the uncertainty about the balance of benefits and harms.
LEVELS OF CERTAINTY REGARDING NET BENEFIT
DescriptionHIGH: The available evidence usually includes consistent results from well-designed, well-conducted
studies in representative primary care populations. These studies assess the effects of the preventive
service on health outcomes. This conclusion is therefore unlikely to be strongly affected by the results of
future studies.
MODERATE: The available evidence is sufficient to determine the effects of the preventive service on
health outcomes, but confidence in the estimate is constrained by such factors as:
The number, size, or quality of individual studies.
Inconsistency of findings across individual studies.
Limited generalizability of findings to routine primary care practice.
Lack of coherence in the chain of evidence.As more information becomes available, the magnitude or direction of the observed effect could change,
and this change may be large enough to alter the conclusion.
LOW: The available evidence is insufficient to assess effects on health outcomes. Evidence is insufficient
because of:
The limited number or size of studies.
Important flaws in study design or methods.
Inconsistency of findings across individual studies.
Gaps in the chain of evidence.
Findings not generalizable to routine primary care practice.
Lack of information on important health outcomes.More information may allow estimation of effects on health outcomes.
The USPSTF defines certainty as "likelihood that the USPSTF assessment of the net benefit of a
preventive service is correct." The net benefit is defined as benefit minus harm of the preventive service
as implemented in a general, primary care population. The USPSTF assigns a certainty level based on the
nature of the overall evidence available to assess the net benefit of a preventive service.