Title: Developing the Topic and Structuring Systematic Reviews of Medical Tests: Utility of PICOTS, Analytic Frameworks, Decision Trees, and Other Frameworks
1Developing the Topic and StructuringSystematic
Reviews of Medical Tests Utility of
PICOTS,Analytic Frameworks, Decision Trees,and
Other Frameworks
- Prepared for
- The Agency for Healthcare Research and Quality
(AHRQ) - Training Modules for Medical Test Reviews Methods
Guide - www.ahrq.gov
2Overview of a Medical Test Review
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
3Learning Objectives
- Describe a guideline for developing topics and
structuring systematic reviews. - Understand the importance of interacting with
stakeholders in formulating topics and their
reviews. - Utilize PICOTS (population, intervention,
comparator, outcomes, timing, and setting)
typology, frameworks, and decision trees to - Minimize ambiguity.
- Identify where resources should be focused.
- Guide the presentation of results.
- Recognize when it is sufficient to focus only on
accuracy studies.
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
4Background
- Topic development The process by which the
foundation and structure of effective systematic
reviews are created. - Through this process the reviewers will
- Learn/clarify how a test might be of value in
practice (e.g., specify the clinical context in
which the test might be used) - Establish Key Questions to guide decisionmaking.
- Structuring the review The process by which the
most direct analytic strategy is identified to
account for idiosyncrasies of the data. - These are complementary processes as the topic
is developed/refined, the necessary structure of
the review becomes more apparent.
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
5Challenges of Conducting Systematic Reviews of
Medical Tests
- An ambiguous description of the claims regarding
the test that does not identify - The target population
- The specific role of the test in clinical
decisionmaking - The indirect impact of medical tests requires
- Linkage of medical tests, intermediate outcomes,
and improved clinical outcomes - Identification of intermediate outcomes
- Limitations of the scientific literature
- Direct evidence for the effect of test strategies
on health outcomes (e.g., randomized controlled
trial results) is rare. - Intermediate outcomes (e.g., test accuracy) are
often used instead.
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
6Principles Used To Address the Challenges of
Conducting a Systematic Review of Medical Tests
- Use the PICOTS (population, intervention,
comparator, outcomes, timing, and setting)
typology to engage stakeholders. - Develop an analytic framework.
- Consider using decision trees.
- Sometimes it is sufficient to focus exclusively
on accuracy studies. - Other frameworks may be helpful.
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
7Principle 1 Use the PICOTS Typology To Engage
Stakeholders (1 of 4)
- Often there is a wide variety of stakeholders
- U.S. Food and Drug Administration
- Government funding agencies
- Technical and clinical experts
- Patients
- Health care providers
- Payers
- Policymakers
- Manufacturers
PICOTS population, intervention, comparator,
outcomes, timing, and setting
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
8Principle 1 Use the PICOTS Typology To Engage
Stakeholders (2 of 4)
- Hold a dialogue with stakeholders to understand
- The objectives of the review
- Generate Key Questions that address stakeholders
needs. - Decisions the review is likely to affect.
- The relationship of the tests to existing test
strategies - Whether used as replacement, triage, or add-on.
- Range of potential clinical utility.
- Potential adverse consequences of testing.
PICOTS population, intervention, comparator,
outcomes, timing, and setting
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
9Principle 1 Use the PICOTS Typology To Engage
Stakeholders (3 of 4)
- Discussions with stakeholders should focus on the
PICOTS typology. - Refining topics is an iterative process.
- The PICOTS elements may change as the clinical
context become clearer. - Reviewers should consider a plan to manage these
changes.
PICOTS population, intervention, comparator,
outcomes, timing, and setting
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
10Principle 1 Use the PICOTS Typology To Engage
Stakeholders (4 of 4)
- Balance the need for information against the
feasibility of completing the review. - Do the Key Questions reflect the needs of the
stakeholders? - Is there enough time and resources to address all
of these needs? - Are there existing systematic reviews or clinical
guidelines that may be helpful - In describing current strategies for the tests
being reviewed? - In revealing potential benefits and harms of the
tests?
PICOTS population, intervention, comparator,
outcomes, timing, and setting
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
11Principle 2Develop an Analytic Framework (1 of
2)
- Analytic framework a graphical representation
of patient care that - Starts from the point of intervention or testing.
- Leads to all important health outcomes.
- Reveals potential Key Questions along the way.
- Is developed in consultation with stakeholders.
- Strengthens the systematic review process by
- Clarifying the link between testing, intermediate
outcomes and clinical outcomes. - Clarifying Key Questions by illustrating
important decisional dilemmas.
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
12Principle 2Develop an Analytic Framework (2 of
2)
- Prototypical Analytic Framework
- Research Questions
- Direct evidence that testing reduces
- morbidity and/or mortality?
- Test accuracy?
- Impact of test on management?
- Impact of management on health outcomes?
- Impact of management on intermediate outcomes?
- Impact of intermediate outcomes on health
outcomes? - Adverse events, acceptability of test procedure?
- Adverse events of subsequent treatment/ other
tests?
Adapted from Harris RP, Helfand M, Woolf SH, et
al. Am J Prev Med. 2001 Apr20(3) Suppl21-35.
PMID 11306229.
13Principle 3Consider Using Decision Trees (1 of
2)
- Analytic frameworks have limited ability to
- Depict multiple alternative uses of a test.
- Represent potential outcome consequences of
altered clinical decisions due to test results. - Decision trees can be used in conjunction with
analytic frameworks to - Illustrate the potential impact of test results
on management decisions and outcomes. - Provide further clinical context of the topic.
- Clarify Key Questions by
- Identifying relevant indices of diagnostic
accuracy and other statistics. - Revealing which range of possible pathways and
outcomes logically flow from a test strategy.
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
14Principle 3 Consider Using Decision Trees (2 of
2)
- A Sample Decision Tree for Breast Cancer Screening
Blue Cross Blue Shield Technology Evaluation
Center. Full-field digital mammography. TEC
Assessment. 2002 Jul(7).
15Principle 4 Sometimes It Is Sufficient ToFocus
Exclusively on Accuracy Studies (1 of 4)
- When is it sufficient to develop Key Questions
that link outcomes to diagnostic accuracy only? - Case 1
- The new test is as sensitive and specific as the
old test. - The new test also has advantages over the old
test, such as - Fewer adverse effects.
- Less invasive.
- Easier to use.
- Provides results more quickly.
- Lower cost.
- The downstream decisions and outcomes must be
comparable between the two tests.
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
16Principle 4 Sometimes It Is Sufficient ToFocus
Exclusively on Accuracy Studies (2 of 4)
- When is it sufficient to develop Key Questions
that link outcomes to diagnostic accuracy only? - Case 2
- The new test has comparable sensitivity but
greater specificity than the old test, which
avoids further testing and unnecessary treatment. - The same cases must be detected by both tests.
- Example Both tests detect early stage cancer,
rather than the old test detecting early stage
cancer while the new test detects metastatic
cancer. - The treatment efficacy must be unaffected by
which test is used.
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
17Principle 4 Sometimes It Is Sufficient ToFocus
Exclusively on Accuracy Studies (3 of 4)
- Questions to consider
- Are extra cases detected by the new, more
sensitive test similarly responsive to treatment? - Are trials available that include patients
selected to undergo the new test? - Do trials assess whether the new test results
predict response? - If available trials selected only patients
assessed with the old test, do extra cases
represent the same disease spectrum or subtypes
as trial participants? - Are the cases detected with the tests
subsequently confirmed by the same reference
standard? - Does the new test change the definition or
spectrum of disease (e.g., earlier stage)? - Is there heterogeneity of test accuracy and
treatment effect (i.e., do accuracy and treatment
effects vary sufficiently according to the levels
of a patient characteristic to change the
comparison of the old and new tests)?
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
18Principle 4 Sometimes It Is Sufficient To Focus
Exclusively on Accuracy Studies (4 of 4)
- Diagnostic accuracy evidence alone may be
sufficient to support conclusions about a new
test if the following conditions are met - The answer to each of the questions below is
yes. - Are extra cases detected by the new, more
sensitive test similarly responsive to treatment? - Are trials available that selected patients to
undergo the new test? - Do trials assess whether the new test results
predict response? - If available trials selected only patients
assessed with the old test, do extra cases
represent the same disease spectrum or subtypes
as trial participants? - Are the cases detected with the tests
subsequently confirmed by the same reference
standard? - The clinical utility of an older comparator test
has been established.
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
19Principle 5 Other Frameworks May Be Helpful (1
of 3)
- Use additional organizational frameworks to
- Categorize the Key Questions.
- Identify which types of studies will address
specific questions in the review. - Review cluster studies together to improve
readability. - Most organizational frameworks line up with the
analytical framework and PICOTS elements.
PICOTS population, intervention, comparator,
outcomes, timing, and setting
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
20Principle 5 Other Frameworks May Be Helpful (2
of 3)
- Other organizational frameworks generally
classify medical test research into six different
domains - Technical efficacy
- Diagnostic accuracy
- Diagnostic thinking efficacy
- Therapeutic efficacy
- Patient outcome
- Societal aspects
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
21Principle 5 Other Frameworks May Be Helpful (3
of 3)
- Six Research Domains Overlaid on the PICOTS
Typology and an Analytic Framework
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
www.effectivehealthcare.ahrq.gov/medtestsguide.cfm
.
22Cases Illustrating the Five Principles
- The cases are three projects that followed this
process of topic development - General topic
- Initial ambiguous claim
- Key concerns suggested by PICOTS, analytic
frameworks, and decision trees - Refined claim
- The cases represent one of three test classes
replacement, add-on, and triage.
PICOTS population, intervention, comparator,
outcomes, timing, and setting
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
23Topic Refinement Process General Topics
- Project 1 (replacement test) Full-field digital
mammography to replace screen-film mammography in
breast cancer screening - Project 2 (add-on test) Human epidermal growth
factor receptor 2 (HER2) gene amplification assay
as add-on to HER2 protein expression assay - Project 3 (triage test) Fluorodeoxyglucose
positron emission tomography as triage for breast
biopsy
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
24Sample Replacement Test ProjectFFDM Versus SFM
(1 of 4)
- Initial ambiguous claim Full-field digital
mammography (FFDM) may be a useful alternative to
single-field mammography (SFM) in screening for
breast cancer. - Key concerns suggested by the PICOTS typology, an
analytic framework, and a decision tree - Key statistics sensitivity, diagnostic yield,
and recall rate - Similar types of management decisions and
outcomes for index and comparator test-and-treat
strategies
PICOTS population, intervention, comparator,
outcomes, timing, and setting
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
25Sample Replacement Test ProjectFFDM Versus SFM
(2 of 4)
- Refined claim
- Interpretation, management decisions, and
outcomes of the screening modalities of
full-field digital mammography (FFDM) and
single-field mammography (SFM) would be similar. - FFDM may have a similar recall rate and
diagnostic yield at least as high as SFM. - FFDM images are more expensive but easier to
manipulate and store.
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
26Sample Replacement Test ProjectFFDM Versus SFM
(3 of 4)
- Decision tree developed to investigate downstream
effects
Blue Cross Blue Shield Technology Evaluation
Center. Full-field digital mammography. TEC
Assessment 2002 Jul(7).
27Sample Replacement Test ProjectFFDM Versus SFM
(4 of 4)
- Using the decision tree yielded these results
- The management decisions, accuracy, and
downstream treatment outcomes for both full-field
digital mammography (FFDM) and single-field
mammography are similar. - The key test performance statistics identified
were - Sensitivity
- Diagnostic yield
- Recall rate
- FFDM was chosen as the preferred screening
modality because of the ease with which it stores
and manipulates images.
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
28Sample Add-on Test ProjectHER2 Gene
Amplification Assay (1 of 4)
- Initial ambiguous claim
- Amplification and protein expression assays of
the human epidermal growth factor 2 (HER2) gene
may complement each other as means of selecting
patients for targeted therapy. - Key concerns suggested by the PICOTS typology, an
analytic framework, and a decision tree - Key statistics The proportion of individuals
with intermediate/ equivocal HER2 protein
expression results who have HER2 gene
amplification. - Key outcomes Are related to the effectiveness of
HER2-targeted therapy in this subgroup.
PICOTS population, intervention, comparator,
outcomes, timing, and setting
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
29Sample Add-on Test ProjectHER2 Gene
Amplification Assay (2 of 4)
- Refined claim
- Patients with equivocal results for
overexpression of human epidermal growth factor 2
(HER2) protein but positive results for
amplification of the HER2 gene may benefit from
HER2-targeted therapy but otherwise would have
been missed.
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
30Sample Add-on Test ProjectHER2 Gene
Amplification Assay (3 of 4)
- Decision tree developed to investigate treatment
outcomes
Seidenfeld J, Samson DJ, Rothenberg BM, et al.
Evid Rep Technol Assess Full Rep) 2008 Nov
(172)1-362. PMID 19408965.
31Sample Add-on Test ProjectHER2 Gene
Amplification Assay (4 of 4)
- Results from using the decision tree
- Treatment outcomes are as important as test
accuracy. - The key test performance statistic was
identified - The proportion of individuals with equivocal
protein expression results but with positive gene
assay results. - A new Key Question was identified
- Is HER2-targeted therapy (surgery and adjuvant
chemotherapy with HER2-targeting agents)
effective for patients with equivocal results on
the protein assay but subsequently had positive
amplified HER2 gene assay results?
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
32Sample Triage Test ProjectPositron Emission
Tomography (1 of 4)
- Initial ambiguous claim
- Positron emission tomography may play an
adjunctive role to breast examination and
mammography in detecting breast cancer and
selecting patients for biopsy. - Key concerns suggested by the PICOTS typology, an
analytic framework, and a decision tree - Key statistics Negative predictive value
- Key outcomes Benefits of avoiding biopsy versus
harms of delaying initiation of treatment for
undetected tumors
PICOTS population, intervention, comparator,
outcomes, timing, and setting
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
33Sample Triage Test ProjectPositron Emission
Tomography (2 of 4)
- Refined claim
- If fluorodeoxyglucose positron emission
tomography (FDG-PET) is performed before biopsy,
women with negative FDG-PET results may avoid the
adverse events of biopsy with potentially
negligible risk of delayed treatment for an
undetected tumor.
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
34Sample Triage Test ProjectPositron Emission
Tomography (3 of 4)
- Decision tree developed to investigate several
testing strategies
Samson DJ, Flamm CR, Pisano ED, et al. Acad
Radiol 2002 Jul9(7)773-83. PMID 12139091.
35Sample Triage Test ProjectPositron Emission
Tomography (4 of 4)
- Results from use of the decision tree
- Key test performance statistic identified
Negative predictive value of PET - Key difference in outcomes between testing
strategies identified Harms of delaying
treatment due to false negative PET vs. avoiding
adverse effects of biopsy due to true negative
PET - The review concluded that there is no significant
benefit from using PET as triage
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
36Key Messages
- Topic development/refinement should be -
- Interactive and iterative.
- Aimed at understanding and clarifying the test
claim. - Performed with input from stakeholders.
- PICOTS typology, analytic frameworks, decision
trees, and other organizational frameworks are
helpful in - - Minimizing ambiguity.
- Identifying where resources should be focused.
- Presenting results.
- In specific instances, focusing only on accuracy
studies (e.g. sensitivity and specificity) is
sufficient.
PICOTS population, intervention, comparator,
outcomes, timing, and setting
Samson D, Schoelles KM. Developing the topic and
structuring systematic reviews of medical tests.
In Methods guide for medical test reviews.
Available at www.effectivehealthcare.ahrq.gov/medt
estsguide.cfm.
37Practice Question 1 (1 of 2)
- Understanding the clinical context of how a test
will be used is important before starting a
systematic review. All of the following are
elements of clinical context except - Patient characteristics
- Clinical setting
- Sensitivity of the test
- Management options
38Practice Question 1 (2 of 2)
- Explanation for Question 1
- The correct answer is c. Test sensitivity is
considered an intermediate outcome, not part of
clinical context. Some of the elements of
clinical context include patient characteristics,
how the test will fit into existing pathways,
technical details of the test, and management
options.
39Practice Question 2 (1 of 2)
- What is the purpose of engaging stakeholders in
topic development of a systematic review? - To understand the decisions the review is likely
to affect. - To understand the range of potential clinical
utility. - To understand potential adverse consequences of
testing. - All of the above.
40Practice Question 2 (2 of 2)
- Explanation for Question 2
- The correct answer is d. The stakeholders will be
the users of the finished review. They should be
engaged in discussions to understand the
objectives of the review in practical terms in
order to develop the review to best fit their
needs.
41Practice Question 3 (1 of 2)
- Decision trees are used to
- Outline the Key Questions for a systematic
review. - Explain essential details of the test.
- Show one set of possible outcomes that result
from testing. - Represent the impact of test results on
management decisions.
42Practice Question 3 (2 of 2)
- Explanation for Question 3
- The correct answer is d. Decision trees are
helpful for graphically showing the impact of
test results on clinical decisions including the
potential outcome consequences of altered
decisions. Decision trees show the impact of test
results on multiple management decisions and
outcomes. A flow diagram would be a type of
decision tree.
43Practice Question 4 (1 of 2)
- It is never sufficient to focus exclusively on
accuracy studies when conducting a systematic
review of a medical test. - True
- False
44Practice Question 4 (2 of 2)
- Explanation for Question 4
- The statement is false. There are certain
settings where it is sufficient to focus
exclusively on accuracy studies. For example,
when a new test is as sensitive and as specific
as the old test and the new test has advantages
such as fewer adverse effects, then diagnostic
accuracy may be sufficient to assess.
45Authors
- This presentation was prepared by Brooke
Heidenfelder, Rachael Posey, Lorraine Sease, Remy
Coeytaux, Gillian Sanders, and Alex Vaz, members
of the Duke University Evidence-based Practice
Center. - The module is based on Chapter 2, Developing the
Topic and Structuring Systematic Reviews of
Medical Tests Utility of PICOTS, Analytic
Frameworks, Decision Trees,and Other Frameworks.
In Methods Guide for Medical Test Reviews. AHRQ
Publication No. 12-EC017. Rockville, MD Agency
for Healthcare Research and Quality June 2012.
www.effectivehealthcare.ahrq.gov/medtestsguide.cfm
.
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