Patient-reported outcomes for asthma in children and adults. Guided Discussion to Facilitate SAFTINet Stakeholders' Selection of an Asthma PROM. Teleconference. 1 April 2011

1. Patient-reported outcomes for
asthma in children and adults
Marion Sills, MD, MPH
Barbara Yawn, MD, MPH
Monica Federico, MD
Bethany Kwan, PhD, MSPH
Presentation to the SAFTINet PEC
April 1, 2011

2. Asthma Monitoring
• Office based pulmonary
function test units to be
installed by SAFTINet
in partner practices*
*Only on April 1

3. Objectives of this discussion
• Present 2 asthma PRO tools, including pros and
cons of each
• Discuss process for selecting one tool that will
be used by all partners
• Discuss questions, considerations, and
processes that each organization will need to
address
• Timeline

4. Review: SAFTINet partners’ current
use of asthma PRO tools
• Assessments in narratives only
• No use of standardized, validated, uniform tools

5. SAFTINet Partner Requirements for a
PRO tool
• Simplicity
• Does not interfere with workflow
• Appropriate for literacy level and language of
patient populations
• Alignment with other organizational efforts and
initiatives

6. Rationale for use of PROs for children
and adults with asthma in SAFTINet
• Clinical utility
– Screening tool
– Patient monitoring tool
– Patient centered care (feedback to patients)
– Decision aid
– Facilitating multidisciplinary team communications
• Research utility
– Standardized evaluation of outcomes
• Why asthma?
– Effects of disease on functioning and quality of life not accounted for in
standard EHR data
– Severity of disease difficult to assess
– Patients experience symptoms (unlike hypertension)

7. What the guidelines say
• Expert Panel Report 3 (EPR-3):
Guidelines for the Diagnosis and
Management of Asthma
• EPR-3: “The key elements of
assessment and monitoring are
refined to include the separate, but
related, concepts of severity,
control, and responsiveness to
treatment.”

8. What the guidelines say
• EPR-3 recommends that clinicians
– Identify precipitating factors
– Identify comorbidities that may aggravate asthma
– Assess patient’s knowledge/skills for self-mgt
– Classify asthma severity

9. What the guidelines say
• EPR-3 recommends that clinicians
– Identify precipitating factors
– Identify comorbidities that may aggravate asthma
[from chart, history]
– Assess patient’s knowledge/skills for self-mgt
– Classify asthma severity

10. What the guidelines say
• EPR-3 recommends that clinicians
– Identify precipitating factors
– Identify comorbidities that may aggravate asthma
[from chart, history]
– Assess patient’s knowledge/skills for self-mgt
– Classify asthma severity

11. What the guidelines say
• EPR-3 recommends that clinicians
– Classify asthma severity
“Assessment is made on the basis of current
spirometry and the patient’s recall of symptoms
over the previous 2–4 weeks.”

12. What the guidelines say
• EPR-3 recommends that clinicians
– Classify asthma severity
• Nighttime awakenings
• Daytime symptoms
• Need for SABA* for quick relief of symptoms
• Work/school days missed
• Ability to engage in normal daily activities or in
desired activities
• Quality-of-life assessments
*SABA: short-acting beta-agonist, a “rescue” or “quick relief” medication

13. What the guidelines say
EPR-3 recommendation ACT APGAR
Precipitating factors
Patient’s self-mgt knowledge/skills
Nighttime awakenings
Daytime symptoms
Need for rescue SABA
Work/school days missed
Engage in normal daily activities
Quality-of-life

14. Proposed tools
• Asthma Control Test (ACT, C-ACT)
• Asthma APGAR

15. ACT
• 2 versions: adult (5
questions) and child (7
questions)
• GlaxoSmithKline product
• Score range 5-25; <20
may indicate need for
greater asthma control

17. Engage in normal daily activities
Nighttime awakenings
Daytime symptoms
Overall (acute) severity

18. Daytime symptoms
Daytime symptoms
Nighttime awakenings

19. Engage in normal daily activities
Nighttime awakenings
Daytime symptoms
Overall severity
Need for rescue SABA

20. Comparing ACT to EPR-3 recommendations
EPR-3 recommendation ACT APGAR
Precipitating factors N
Patient’s self-mgt knowledge/skills N
Nighttime awakenings Y
Daytime symptoms Y
Need for rescue SABA Y (adult)
Work/school days missed N
Engage in normal daily activities Y
Quality-of-life Y
4 weeks of symptoms
Adult and child
4-5 options/question
5-7 questions
<20 = poor control

21. ACT pros and cons
PROs
• Well validated
• Widely used
• Minimal level for good
control and MCID
established
• Translated into many
languages
CONs
• Long questions
• Does not include days
missed from school/work
• No guide to how to use
the results
• Not studied in association
with clinical outcomes

22. ACT pros
Widely validated

23. If ACT <20, then what?

24. Asthma APGAR
• Designed to measure severity to include elements
missing in > 60% of primary care charts:
– trigger exposure
– adherence to prescribed therapy
– patient reported value of their asthma therapy
• Developed by Dr. Yawn in collaboration with
practicing primary care physicians—
– face validity
– practical

25. ASTHMAAPGAR
Engage in
normal daily
activities
Daytime symptoms
Nighttime awakenings
Precipitating
factors
Patient’s self-mgt
knowledge/skills
Need for rescue SABA
Quality-of-life
Patient’s
self-mgt
knowledge/
skills

26. Comparing ACT and APGAR to EPR-3
EPR-3 recommendation ACT APGAR
Precipitating factors N Y
Patient’s self-mgt knowledge/skills N Y
Nighttime awakenings Y Y
Daytime symptoms Y Y
Need for rescue SABA Y (adult) Y
Work/school days missed N N
Engage in normal daily activities Y Y
Quality-of-life Y Y
4 weeks of symptoms
Adult and child
4-5 options/question
5-7 questions
<20 = poor control
2 weeks of symptoms
No child version
3 options/question
8 questions
Algorithm for mgt

27. Asthma APGAR
• PROs
– Addresses missed and modified activities
– Addresses most common causes of poor control
– Is linked to an algorithm for next steps
– Shown to improve outcomes in clinical practice
– Test/retest, face validity and comparable to EPR-3
• CONs
– Not compared to ACT for validation
– Minimally clinically significant difference unknown

28. APGAR algorithm

29. Comparing the ACT and the Asthma
APGAR
• Similarities
– Test for symptoms, activity limitations, and use of
rescue medications
• Differences
– ACT more widely validated
– ACT is shorter
– ACT has child version
– APGAR has linked treatment algorithm
– APGAR addresses asthma triggers, adherence to
prescribed medications, and patient’s perception of
asthma relief from therapy

30. Questions and considerations
• What would the tool be used for in your organization?
• What resources are required?
• Which patients will you assess?
• How often should patients complete questionnaires? Should
it be tied to visits or a way to follow patients between visits?
• How will the tool be administered and scored?
• What tools are available to aid in interpretation and how will
scores requiring follow-up be determined?
• When, where, how, and to whom will results be presented?
• How will the value of using PROs be evaluated?
• Which key barriers require attention?

31. Clinical utility
• Likely utility of Asthma PROs:
– Patient monitoring tool
– Decision aid
• Less likely utility for asthma PROs
– Screening tool
– Feedback to patients
– Facilitating multidisciplinary team
communications

32. Resources
• Manpower
• Information systems and technical support
• Space
• Financial investment (SAFTINet funds available)

33. Selecting patients to complete the tool
• Ambulatory patients with asthma
– How would they be identified?
• How often would they complete the tool?
– Every ambulatory visit?
• When does the patient complete the tool?
– Beginning of visit?

34. Mode of administration
• Person completing the tool
• Self-administration
• Interviewer administration
• Medium for presentation of tool and data
collection
• Pencil and paper survey
• EHR template
• Portable devices (e.g., iPad)
• Web-based
• Telephony-based

35. Scoring
• Who will score the results?
• Patient
• Member of the health care team
• What tools are available to assist with scoring?

36. Presentation of results
• Are results presented to patient/provider?
• If yes:
• When are results presented?
• At time of visit?
• Where are results presented?
• Part of workflow?
• How are results presented?
• Numeric or graphical presentation

37. Data entry
• How will data be entered?
• Depends on mode of administration

38. Interpreting and responding to scores
• Algorithms (Asthma APGAR)
• Meaningful scores (ACT)
• Linking to clinical guidelines

39. Evaluation
• Plans for evaluating use of tool on:
• Process/workflow
• Quality of care

40. Barriers
• Clinicians
– Lack of familiarity with the instruments
– Doubt about the ability of pros to modify outcomes
– Time and resource constraints
– Disagreements over impact on patient-clinician relationship
• Patients
– Literacy
– Being too sick to complete questionnaires
– Concern about impact on relationship with clinician
• Health system
– Reimbursement
– Fit within the clinical workflow

41. Anticipated barriers
• Generate list of perceived barriers and potential
solutions

42. Process for selecting a tool and an
implementation strategy
• Provider meetings?
• IT conversations?
• Decision making?
• Trainings?

43. Organization Worksheet
• Walks through the different issues and
processes discussed today
• To be completed by organization, with
assistance from PEC liaison
• Weekly phone calls with PEC liaison

44. Proposed Timeline - 2011
Explore
options for
asthma PROs
Discuss PRO
with provider
groups
Select asthma
PRO tool
Make
implementation
plan for
asthma PRO
tool
Create
infrastructure
for PRO tool
deployment
(e.g., EHR
template, iPad
purchase &
configuration)
PRO tool
training
Begin using
asthma PRO
tool
March April May June July Sept Oct