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Using the Medical Literature to
Make Decisions About Preventive
Health Services
Dr Jose Poulose (M.B.B.S)
Learning Objectives
• Review the burden of chronic preventable diseases
in the United States.
• Estimate the potential for improving health
through effective clinical prevention.
• Understand the importance of using an evidence-
based process to develop preventive health
guidelines based on searches of the medical
literature.
• Introduce multiple tools for accessing preventive
health information at the point of care.
“An ounce of prevention is worth a pound
of cure”
Burden of Chronic Illness in
the United States
Causes of Death - Diagnoses, 2000
Cause No of deaths death rate*
• Heart disease 710 760 258.2
• Cancer 553 091 200.9
• Cerebrovascular disease 167 661 60.9
• COPD 122 009 44.3
• Unintentional injuries 97 900 35.6
• Diabetes mellitus 69 301 25.2
• Influenza and pneumonia 65 313 23.7
• Alzheimer disease 49 558 18
• Nephritis/nephrosis 37 251 13.5
• Septicemia 31 224 11.3
• Other 499 283 181.4
• Total 2 403 351 873.1
* Per 100,000
Ref: Mokdad AH, Marks JS, Stroup DF, Gergerding JL. JAMA. 2004;291:1238-1245
Actual Causes of Death - 2000
Actual Cause No. (%) in 1990* No. (%) in 2000
Tobacco 400 000 (19) 435 000 (18.1)
Diet/phys. inactivity 300 000 (14) 365 000 (15.2)
ETOH 100 000 (5) 85 000 (3.5)
Microbial agents 90 000 (4) 75 000 (3.1)
Toxic agents 60 000 (3) 55 000 (2.3)
Motor vehicle 25 000 (1) 43 000 (1.8)
Firearms 35 000 (2) 29 000 (1.2)
Sexual behavior 30 000 (1) 20 000 (0.8)
Illicit drug use 20 000 (1) 17 000 (0.7)
Total 1 060 000 (50) 1 124 000
(46.7)
Ref: Mokdad AH, Marks JS, Stroup DF, Gergerding JL. JAMA. 2004;291:1238-1245
Preventable Deaths in the U.S.
U.S. ranks last among industrialized nations in
preventable deaths
Could prevent 100,000 deaths annually if rates
were similar to high-performing nations
Health Affairs, Sept. 2006
Mortality Amenable to Health Care
U.S. Rank Fell from 15th to Last out of 19 Countries
76
81
88
84
89 89
99 97
88
97
109 106
116 115 113
130
134
128
115
65
71 71 74 74 77 80 82 82 84 84 90 93 96 101 103 103 104 110
0
50
100
150
France
Japan
Australia
Spain
Italy
Canada
NorwayNetherlands
Sweden
Greece
AustriaGerm
any
Finland
New
Zealand
Denm
ark
United
Kingdom
Ireland
Portugal
United
States
1997/98 2002/03
Deaths per 100,000 population*
* Countries’ age-standardized death rates, ages 0–74; includes ischemic heart disease.
Source: Commonwealth Fund; E. Nolte and C. M. McKee, Measuring the Health of Nations: Updating an
Earlier Analysis, Health Affairs, January/February 2008, 27(1):58–71
Costs of Preventable Diseases
We cannot effectively address escalating health care costs
without addressing the problem of chronic diseases and
finding ways to delay or prevent their onset.
 More than 90 million Americans live with chronic illness
 Chronic diseases account for 70% of all deaths in the U.S.
 The medical costs of people with chronic diseases account for
more than 75% of the nation’s approximately $1.5 trillion in
annual medical care costs.
Challenges in Prevention
• Most important messages about prevention may not
be getting through to clinicians and patients
• Not everything that might work does work
• Services should be supported by good evidence (but
often aren’t) before they are widely recommended
• Necessity of providing individual preventive services
often skewed by:
– Beliefs, anecdotal experiences of clinicians and patients
– Inaccurate media messages
– Advocacy groups
– Political considerations
Primary care: is there time enough for
prevention?
• Yarnall KS et al., Am J Public Health, 2003
• Used published and estimated times to
determine the total physician time required to
provide all recommended preventive services
to a patient panel of 2500 with an age and sex
distribution similar to that of the US
population
• 1773 hours annually, or 7.4 hours per working
day
How much time do primary care clinicians
actually spend on preventive care?
• Pollak KI et al., BMJ Health Serv Res, 2008
• Data on family and internal medicine visits from
2001-04 National Ambulatory Medical Care Survey
• Most time spent on: PSA (4.9 minutes), cholesterol,
Pap smear, mammograms, exercise counseling, and
blood pressure
• Spent less time than recommended on tobacco
cessation (0.11 vs. 3 minutes) and nutrition
counseling (1.34 vs. 8.2 minutes)
Rethinking Current Health Approaches
Problem of Underuse of Clinical Preventive
Services
• Insurance coverage makes a difference in whether
people receive preventive services
• Approximately half (52%) of adults receive
preventive care according to guidelines for their age
and sex.1
• In 2004, NCQA identified 48,600 cases of late-stage
breast cancer and colorectal cancer and
osteoporosis-related fractures that could have been
averted if individuals received appropriate and
timely preventive care.2
Sources: 1. The Commonwealth Fund Commission on a High Performance Healthcare System, Sept 2006; 2.
National Committee for Quality Assurance. The State of Healthcare Quality 2005. Washington, DC; NCQA: 2006.
Preventive Services in Health Reform
Why Evidence-Based?
• Need transparent, systematic process to
obtain and distill best available evidence to
support clinical decision making
– Identifying, evaluating and summarizing
scientific evidence about outcomes or
interventions or policies
– Translating research evidence into clinical
practice recommendations
General Attributes of Good Clinical
Practice Guidelines
• Comprehensive, systematic evidence search
• Evidence linked directly to recommendations via
strength of recommendation grading system
• Recommendations based on patient-oriented rather
than disease-oriented outcomes
• Development process is transparent
• Potential conflicts of interest identified and addressed
• Prospective validation
• Clinical flexibility
U.S. Preventive Services Task Force:
Prevention in the Clinical Setting
What is the US Preventive Services
Task Force?
• Congressionally mandated, independent panel of non-Federal experts
in prevention and evidence-based medicine, established in 1984
• 16 primary care clinicians (internists, pediatricians, family physicians,
ob/gyns, nurses and health behavior specialists) appointed to rotating
4-year terms
What is the USPSTF Mission?
“to evaluate the benefits of individual [preventive] services based on age,
gender, and risk factors for disease;
make recommendations about which preventive services should be
incorporated routinely into primary medical care and for which
populations;
and identify a research agenda for clinical preventive care.”
Who Supports the USPSTF?
• Administrative, research, technical and dissemination
support provided by the Agency for Healthcare Research
and Quality (AHRQ), a division of the Department of
Health and Human Services (DHHS)
• Scientific support from AHRQ-funded Evidence-Based
Practice Centers (EPCs)
 EPCs conduct systematic evidence reviews on topics in
clinical prevention that serve as the scientific basis for
USPSTF recommendations
What are US Preventive Services
Task Force Activities?
• Guidelines published in the form of “recommendation
statements”
• 2010 Affordable Care Act singles out positive
recommendations by the USPSTF ( “A” or “B”) for
coverage without cost-sharing
• Recommendations are graded to convey two major
elements: certainty and magnitude of net benefit of
the preventive service
The USPSTF Steps:
Brief and Generic
Step 1: Define key questions and outcomes, including an
analytic framework
(Note: CEA = carotid endarterectomy)
The USPSTF Steps:
Brief and Generic
Step 2: Define, retrieve and summarize relevant evidence from the medical literature
Step 3: Judge quality of individual studies:
good, fair, poor
Step 4: Synthesize and judge the adequacy of the evidence about benefits and harms:
convincing, adequate, inadequate
Systematic Reviews
• A planned, comprehensive, reproducible, exhaustive
review of the world’s literature on a given topic
• Includes electronic resources (e.g., MEDLINE,
EMBASE), experts and review of reference lists
• May include unpublished studies (but often does not,
so ‘publication bias’ is always a concern)
• Always valuable
The USPSTF Steps (continued):
Step 5: Determine and judge the magnitude of both
benefits and harms: substantial, moderate, small, zero
Step 6: Determine and judge the balance of benefits and harms (net benefit)
Step 7: Judge the certainty of net benefit: low, moderate, high
Step 8: Judge the magnitude of net benefit: substantial, moderate, small,
zero/negative
Step 9: Assign a letter grade: A, B, C, D, I
Concept of “Net Benefit”
• Net Benefit = Benefits minus Harms of preventive
service
• USPSTF recommends that clinicians routinely provide
services that have strong evidence of large (“A”) or
moderate (“B”) net benefit
• USPSTF does not routinely recommend services that
provide small (“C”) or zero (“D”) net benefit
• If unable to determine net benefit, TF issues “I”
(insufficient evidence) statement
USPSTF Grades of Recommendations
Certainty of NetCertainty of Net
BenefitBenefit
Magnitude of Net BenefitMagnitude of Net Benefit
SubstantialSubstantial ModerateModerate SmallSmall Zero/negativeZero/negative
HighHigh AA BB CC DD
ModerateModerate BB BB CC DD
LowLow InsufficientInsufficient
Accessing Prevention Guidelines at the Point of
Care
• Annual pocket-sized Guide to Clinical Preventive
Services
• www.uspreventiveservicestaskforce.org
• Web-based and PDA Electronic Preventive Services
Selector (ePSS)
• www.healthfinder.gov (for patients)
• Essential Evidence Plus online and mobile resource
• American Family Physician journal
ePSS app for smartphones
ePSS app for smartphones
Contending with “prevention
for profit”
Not everything that might work does
work – that’s why guidelines require
evidence!
An advertisement in my church’s bulletin
earlier this year
• Life Line Screening, the nation's leading provider of
preventive health screenings, will offer their affordable, non-
invasive, painless health screenings.
• Five screenings will be offered that scan for potential health
problems related to: blocked arteries, which is a leading
cause of stroke; abdominal aortic aneurysms, which can lead
to a ruptured aorta; hardening of the arteries in the legs,
which is a strong predictor of heart disease; atrial fibrillation
or irregular heart beat, which is closely tied to stroke risk; and
a bone density screening, for men and women, used to
assess the risk of osteoporosis.
• Register for a Wellness Package with Heart Rhythm for $149.
Add Disease Risk Assessment with blood testing & biometrics
for $79 more.
Sounds good … but what does
the evidence say?
USPSTF Systematic Reviews,
2005 through 2010
Stroke screenings? Just say no
• "Blocked arteries" / stroke screening is most likely a
carotid ultrasound scan, which doesn't help because
most patients with asymptomatic carotid artery
blockages will not suffer strokes. Although the
screening test is "non-invasive and painless," the
confirmatory test, angiography, is not (it actually
causes a stroke in a small number of patients) and
unnecessary carotid endarterectomy can lead to
death.
AAA screening? Not for most people
• Abdominal aortic aneurysm screening is only
recommended in men ages 65 to 75 who have
ever smoked, because aneurysms are much
less common in younger, female, and non-
smoking populations. Even in men who are
eligible for the test, it's important to weigh
the potential benefits against the potential
harms of corrective surgery, which has a not
insignificant mortality rate itself.
Pass on screening for PVD
• "Hardening of the arteries in the legs," or
screening for peripheral vascular disease with
an arterial-brachial index, hasn't been proven
to prevent heart attacks but will certainly lead
to many false positive results.
Screening for atrial fibrillation? Are you
kidding me?
• I've never even heard of atrial fibrillation
(irregular heart beat) screening, which I
presume is doing a screening EKG, which is
also totally unproven. Absolutely no
organizations recommend this.
Even “good” screening tests should be
cleared by clinicians
• Screening for osteoporosis with bone density testing
is the only test on the list that's actually worthwhile
for a large number of adults, especially women over
65. But it's not appropriate to do this test without a
prior consultation with a clinician who can discuss
the risks and benefits of undergoing this type of
screening. And there are still questions about
whether men benefit to the same degree as women,
or at all.
The Bottom Line
• Preventive services have great potential to
improve national health outcomes
• An evidence-based process is critical to select
services of value and discourage ineffective
and/or harmful tests
• That process is based upon a careful,
systematic search of the medical literature on
a topic
• Clinicians have many options for accessing
prevention guidelines at the point of care
Thank you!
Questions?

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| Jose Poulose | Preventive health services by Dr jose poulose |

  • 1. Using the Medical Literature to Make Decisions About Preventive Health Services Dr Jose Poulose (M.B.B.S)
  • 2. Learning Objectives • Review the burden of chronic preventable diseases in the United States. • Estimate the potential for improving health through effective clinical prevention. • Understand the importance of using an evidence- based process to develop preventive health guidelines based on searches of the medical literature. • Introduce multiple tools for accessing preventive health information at the point of care.
  • 3. “An ounce of prevention is worth a pound of cure” Burden of Chronic Illness in the United States
  • 4. Causes of Death - Diagnoses, 2000 Cause No of deaths death rate* • Heart disease 710 760 258.2 • Cancer 553 091 200.9 • Cerebrovascular disease 167 661 60.9 • COPD 122 009 44.3 • Unintentional injuries 97 900 35.6 • Diabetes mellitus 69 301 25.2 • Influenza and pneumonia 65 313 23.7 • Alzheimer disease 49 558 18 • Nephritis/nephrosis 37 251 13.5 • Septicemia 31 224 11.3 • Other 499 283 181.4 • Total 2 403 351 873.1 * Per 100,000 Ref: Mokdad AH, Marks JS, Stroup DF, Gergerding JL. JAMA. 2004;291:1238-1245
  • 5. Actual Causes of Death - 2000 Actual Cause No. (%) in 1990* No. (%) in 2000 Tobacco 400 000 (19) 435 000 (18.1) Diet/phys. inactivity 300 000 (14) 365 000 (15.2) ETOH 100 000 (5) 85 000 (3.5) Microbial agents 90 000 (4) 75 000 (3.1) Toxic agents 60 000 (3) 55 000 (2.3) Motor vehicle 25 000 (1) 43 000 (1.8) Firearms 35 000 (2) 29 000 (1.2) Sexual behavior 30 000 (1) 20 000 (0.8) Illicit drug use 20 000 (1) 17 000 (0.7) Total 1 060 000 (50) 1 124 000 (46.7) Ref: Mokdad AH, Marks JS, Stroup DF, Gergerding JL. JAMA. 2004;291:1238-1245
  • 6. Preventable Deaths in the U.S. U.S. ranks last among industrialized nations in preventable deaths Could prevent 100,000 deaths annually if rates were similar to high-performing nations Health Affairs, Sept. 2006
  • 7. Mortality Amenable to Health Care U.S. Rank Fell from 15th to Last out of 19 Countries 76 81 88 84 89 89 99 97 88 97 109 106 116 115 113 130 134 128 115 65 71 71 74 74 77 80 82 82 84 84 90 93 96 101 103 103 104 110 0 50 100 150 France Japan Australia Spain Italy Canada NorwayNetherlands Sweden Greece AustriaGerm any Finland New Zealand Denm ark United Kingdom Ireland Portugal United States 1997/98 2002/03 Deaths per 100,000 population* * Countries’ age-standardized death rates, ages 0–74; includes ischemic heart disease. Source: Commonwealth Fund; E. Nolte and C. M. McKee, Measuring the Health of Nations: Updating an Earlier Analysis, Health Affairs, January/February 2008, 27(1):58–71
  • 8. Costs of Preventable Diseases We cannot effectively address escalating health care costs without addressing the problem of chronic diseases and finding ways to delay or prevent their onset.  More than 90 million Americans live with chronic illness  Chronic diseases account for 70% of all deaths in the U.S.  The medical costs of people with chronic diseases account for more than 75% of the nation’s approximately $1.5 trillion in annual medical care costs.
  • 9. Challenges in Prevention • Most important messages about prevention may not be getting through to clinicians and patients • Not everything that might work does work • Services should be supported by good evidence (but often aren’t) before they are widely recommended • Necessity of providing individual preventive services often skewed by: – Beliefs, anecdotal experiences of clinicians and patients – Inaccurate media messages – Advocacy groups – Political considerations
  • 10. Primary care: is there time enough for prevention? • Yarnall KS et al., Am J Public Health, 2003 • Used published and estimated times to determine the total physician time required to provide all recommended preventive services to a patient panel of 2500 with an age and sex distribution similar to that of the US population • 1773 hours annually, or 7.4 hours per working day
  • 11. How much time do primary care clinicians actually spend on preventive care? • Pollak KI et al., BMJ Health Serv Res, 2008 • Data on family and internal medicine visits from 2001-04 National Ambulatory Medical Care Survey • Most time spent on: PSA (4.9 minutes), cholesterol, Pap smear, mammograms, exercise counseling, and blood pressure • Spent less time than recommended on tobacco cessation (0.11 vs. 3 minutes) and nutrition counseling (1.34 vs. 8.2 minutes)
  • 13. Problem of Underuse of Clinical Preventive Services • Insurance coverage makes a difference in whether people receive preventive services • Approximately half (52%) of adults receive preventive care according to guidelines for their age and sex.1 • In 2004, NCQA identified 48,600 cases of late-stage breast cancer and colorectal cancer and osteoporosis-related fractures that could have been averted if individuals received appropriate and timely preventive care.2 Sources: 1. The Commonwealth Fund Commission on a High Performance Healthcare System, Sept 2006; 2. National Committee for Quality Assurance. The State of Healthcare Quality 2005. Washington, DC; NCQA: 2006.
  • 14.
  • 15. Preventive Services in Health Reform
  • 16. Why Evidence-Based? • Need transparent, systematic process to obtain and distill best available evidence to support clinical decision making – Identifying, evaluating and summarizing scientific evidence about outcomes or interventions or policies – Translating research evidence into clinical practice recommendations
  • 17. General Attributes of Good Clinical Practice Guidelines • Comprehensive, systematic evidence search • Evidence linked directly to recommendations via strength of recommendation grading system • Recommendations based on patient-oriented rather than disease-oriented outcomes • Development process is transparent • Potential conflicts of interest identified and addressed • Prospective validation • Clinical flexibility
  • 18. U.S. Preventive Services Task Force: Prevention in the Clinical Setting
  • 19. What is the US Preventive Services Task Force? • Congressionally mandated, independent panel of non-Federal experts in prevention and evidence-based medicine, established in 1984 • 16 primary care clinicians (internists, pediatricians, family physicians, ob/gyns, nurses and health behavior specialists) appointed to rotating 4-year terms
  • 20. What is the USPSTF Mission? “to evaluate the benefits of individual [preventive] services based on age, gender, and risk factors for disease; make recommendations about which preventive services should be incorporated routinely into primary medical care and for which populations; and identify a research agenda for clinical preventive care.”
  • 21. Who Supports the USPSTF? • Administrative, research, technical and dissemination support provided by the Agency for Healthcare Research and Quality (AHRQ), a division of the Department of Health and Human Services (DHHS) • Scientific support from AHRQ-funded Evidence-Based Practice Centers (EPCs)  EPCs conduct systematic evidence reviews on topics in clinical prevention that serve as the scientific basis for USPSTF recommendations
  • 22. What are US Preventive Services Task Force Activities? • Guidelines published in the form of “recommendation statements” • 2010 Affordable Care Act singles out positive recommendations by the USPSTF ( “A” or “B”) for coverage without cost-sharing • Recommendations are graded to convey two major elements: certainty and magnitude of net benefit of the preventive service
  • 23. The USPSTF Steps: Brief and Generic Step 1: Define key questions and outcomes, including an analytic framework (Note: CEA = carotid endarterectomy)
  • 24. The USPSTF Steps: Brief and Generic Step 2: Define, retrieve and summarize relevant evidence from the medical literature Step 3: Judge quality of individual studies: good, fair, poor Step 4: Synthesize and judge the adequacy of the evidence about benefits and harms: convincing, adequate, inadequate
  • 25. Systematic Reviews • A planned, comprehensive, reproducible, exhaustive review of the world’s literature on a given topic • Includes electronic resources (e.g., MEDLINE, EMBASE), experts and review of reference lists • May include unpublished studies (but often does not, so ‘publication bias’ is always a concern) • Always valuable
  • 26. The USPSTF Steps (continued): Step 5: Determine and judge the magnitude of both benefits and harms: substantial, moderate, small, zero Step 6: Determine and judge the balance of benefits and harms (net benefit) Step 7: Judge the certainty of net benefit: low, moderate, high Step 8: Judge the magnitude of net benefit: substantial, moderate, small, zero/negative Step 9: Assign a letter grade: A, B, C, D, I
  • 27. Concept of “Net Benefit” • Net Benefit = Benefits minus Harms of preventive service • USPSTF recommends that clinicians routinely provide services that have strong evidence of large (“A”) or moderate (“B”) net benefit • USPSTF does not routinely recommend services that provide small (“C”) or zero (“D”) net benefit • If unable to determine net benefit, TF issues “I” (insufficient evidence) statement
  • 28. USPSTF Grades of Recommendations Certainty of NetCertainty of Net BenefitBenefit Magnitude of Net BenefitMagnitude of Net Benefit SubstantialSubstantial ModerateModerate SmallSmall Zero/negativeZero/negative HighHigh AA BB CC DD ModerateModerate BB BB CC DD LowLow InsufficientInsufficient
  • 29. Accessing Prevention Guidelines at the Point of Care • Annual pocket-sized Guide to Clinical Preventive Services • www.uspreventiveservicestaskforce.org • Web-based and PDA Electronic Preventive Services Selector (ePSS) • www.healthfinder.gov (for patients) • Essential Evidence Plus online and mobile resource • American Family Physician journal
  • 30.
  • 31.
  • 32.
  • 33. ePSS app for smartphones
  • 34. ePSS app for smartphones
  • 35.
  • 36.
  • 37.
  • 38.
  • 39.
  • 40.
  • 41.
  • 42.
  • 43. Contending with “prevention for profit” Not everything that might work does work – that’s why guidelines require evidence!
  • 44. An advertisement in my church’s bulletin earlier this year • Life Line Screening, the nation's leading provider of preventive health screenings, will offer their affordable, non- invasive, painless health screenings. • Five screenings will be offered that scan for potential health problems related to: blocked arteries, which is a leading cause of stroke; abdominal aortic aneurysms, which can lead to a ruptured aorta; hardening of the arteries in the legs, which is a strong predictor of heart disease; atrial fibrillation or irregular heart beat, which is closely tied to stroke risk; and a bone density screening, for men and women, used to assess the risk of osteoporosis. • Register for a Wellness Package with Heart Rhythm for $149. Add Disease Risk Assessment with blood testing & biometrics for $79 more.
  • 45.
  • 46. Sounds good … but what does the evidence say? USPSTF Systematic Reviews, 2005 through 2010
  • 47. Stroke screenings? Just say no • "Blocked arteries" / stroke screening is most likely a carotid ultrasound scan, which doesn't help because most patients with asymptomatic carotid artery blockages will not suffer strokes. Although the screening test is "non-invasive and painless," the confirmatory test, angiography, is not (it actually causes a stroke in a small number of patients) and unnecessary carotid endarterectomy can lead to death.
  • 48. AAA screening? Not for most people • Abdominal aortic aneurysm screening is only recommended in men ages 65 to 75 who have ever smoked, because aneurysms are much less common in younger, female, and non- smoking populations. Even in men who are eligible for the test, it's important to weigh the potential benefits against the potential harms of corrective surgery, which has a not insignificant mortality rate itself.
  • 49. Pass on screening for PVD • "Hardening of the arteries in the legs," or screening for peripheral vascular disease with an arterial-brachial index, hasn't been proven to prevent heart attacks but will certainly lead to many false positive results.
  • 50. Screening for atrial fibrillation? Are you kidding me? • I've never even heard of atrial fibrillation (irregular heart beat) screening, which I presume is doing a screening EKG, which is also totally unproven. Absolutely no organizations recommend this.
  • 51. Even “good” screening tests should be cleared by clinicians • Screening for osteoporosis with bone density testing is the only test on the list that's actually worthwhile for a large number of adults, especially women over 65. But it's not appropriate to do this test without a prior consultation with a clinician who can discuss the risks and benefits of undergoing this type of screening. And there are still questions about whether men benefit to the same degree as women, or at all.
  • 52. The Bottom Line • Preventive services have great potential to improve national health outcomes • An evidence-based process is critical to select services of value and discourage ineffective and/or harmful tests • That process is based upon a careful, systematic search of the medical literature on a topic • Clinicians have many options for accessing prevention guidelines at the point of care

Editor's Notes

  1. Furthermore, costs of preventable diseases are an important contributor to health care expenditure and these costs are increasing. (Read above statistics) next
  2. What prevents clinicians and insurance companies from providing or paying for comprehensive preventive services? There are challenges and some of these challenges are (Read above challenges) Next
  3. Presenter: Richard
  4. Presenter: Tricia
  5. We have cartoons too
  6. The last bullet point segues into the next slide.
  7. This slide examines in greater detail the first of the 9 steps that the USPSTF takes to devise a recommendation statement. The process begins with defining the key questions and the analytic framework to answer an overarching question about screening and prevention. Because direct evidence about prevention (e.g., from randomized trials) is often unavailable, the Task Force usually considers indirect evidence. To guide its selection of indirect evidence, a "chain of evidence" is constructed within an analytic framework. The Task Force examines evidence of various research designs that addresses the key questions within the framework. Each arrow in the framework defines a key question, and each key question represents a link in the chain of evidence. Rectangles in the framework represent the intermediate outcomes (rounded corners) or the health outcomes (square corners); ovals represent harms. To form an unbroken chain, evidence must support each link in the chain, thereby connecting the target population (far left side of the framework) to the improved health outcome (far right side of the framework).
  8. Steps 2 and 3 are performed by the EPC. Step 4 is critical and, as do all steps, requires judgment. If evidence is inadequate, an “I” statement will be used. If the evidence is deemed adequate, then the next steps are put into play. Judgment is required at all steps. The USPSTF strives to make the process as explicit and transparent as possible.
  9. This and the next slide illustrate the scope of EPC review of the available evidence.
  10. Step 6 is perhaps the most difficult since the methods by which the balance of benefits and harms is determined are many and consensus on the most appropriate methods has not been established. Finally, steps 7 and 8 provide the two critical elements we saw in the recommendation grid and these lead to the final step: assignment of a letter grade: A, B, C, D. The next few slides go into more detail on some these steps in more detail.
  11. The following slides will focus on how the magnitude and certainty of net benefit are determined.