Download - Pros In Clinical Care
PROS IN CLINICAL CARE
Paul K. Crane, MD MPH
Associate Professor, Department of Medicine, School of MedicineAdjunct Associate Professor, Department of Health Services, School of Public HealthUniversity of Washington
Outline
How did I come to this topic? Intro to PROMIS
How did my wife come to this topic? Intro to CNICS
PROMIS 2 research on depression PROMIS 2 network / Clinical Practice
Subcommittee Future forecast
Outline
How did I come to this topic? Intro to PROMIS
How did my wife come to this topic? Intro to CNICS
PROMIS 2 research on depression PROMIS 2 network / Clinical Practice
Subcommittee Future forecast
My background
UW med school (1997) Internal medicine internship (UW)
and residency (Barnes-Jewish) 1997-2000
Hospitalist and Health Behavior Research fellow 2000-01 (Washington U, St. Louis)
General Internal Medicine Fellow, MPH, UW (2001-03)
Interest in measurement
Decided as a Health Behavior fellow to study diabetes, depression, and health related quality of life
Determined that to know anything about that topic, had to know something about how to measure HRQL Lots of diabetes-specific HRQL scales, all of
which made claims that I did not understand And I thought I knew how to read the medical
literature!
Faries et al. paper
A paper on the Hamilton Depression Rating Scale looked at responsiveness of each item, which they defined as differences between placebo and active treatments with their drug
Certainly didn’t like that way of defining things
But it’s the item, not the scale! Faries D et al. The responsiveness of the Hamilton Depression Rating Scale. Journal of Psychiatric Research 2000; 34: 3-10.
GIM Fellowship: Psychometrics
Worked with Gerald van Belle during fellowship
We taught each other modern psychometrics Hambleton et al. (1991): Fundamentals of Item
Response Theory Embretson and Reise (2000): Item Response
Theory for Psychologists McDonald (1999): Test Theory: a Unified
Treatment Would add to this list:
Wainer et al. (2007): Testlet Response Theory and its Applications.
Fellowship psychometrics research - 1
K08 proposal, “Improving cognitive tests with modern psychometrics” – Alzheimer’s disease specific 3-year K award
Worked with item-level cognitive and PRO data Dan Mungas at UC Davis PROMIS I application on self-reported cognition
Not discussed – “cognition is not important to HRQL”
Became aware of a second UW PROMIS I proposal from Dagmar Amtmann
Psychometrics Research – 2 Dagmar’s project was funded, and
she was happy to have me involved as I wished during my K award.
So, I went.
PROMIS 1 Large project (7 U01 projects, 1 Statistical Coordinating
Center, each with an NIH Project Officer) One Danish physician (Jakob Bjorner) involved with one of
the projects No other practicing clinicians with modern psychometrics
expertise No projects really integrated with clinical care I felt the need to speak up! Network structure; first set of domains built by the Network
Depression; Anxiety; Alcohol abuse; Anger; Physical function; Fatigue impact / experience; Social role performance /satisfaction; Pain interference / quality / behavior
Pilkonis PA et al. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS®): depression, anxiety, and anger. Assessment 2011; 18: 263-283.
Some PROMIS strengths
Extraordinary amount of attention, with reasonable choices made
Item QC led to items that are relatively easy to read, simple to interpret, similarly worded, etc. Domain-to-domain look and feel is consistent
Scores across the domains look similar Direction based on name of domain Scaled so 50 is mean of US, +/- 10 is 1 SD
Attention to intellectual property Increasingly important consideration Proprietary items = $, risk for lawyer involvement
PROMIS Product: Short forms Brief group of items “Developed … based on simulations
of CAT results, item information, and item content” Candidate items identified based on
psychometric characteristics, and then reviewed by content experts (Pilkonis 2011)
PROMIS product: CAT
Efficient and brilliant use of computers You already know the CAT algorithm: pick a
number (“binary search”) Need an item bank, a scoring algorithm,
and a stopping rule Stopping rule can be composite
Result: precise-enough scores for a domain after a very few items (like 4 or 5)
If IRT assumptions are appropriate, it’s very slick! Assumption: all items are equally useful
PROMIS 2
1 coordinating center becomes 3 (technology center, statistical center, network center
12 PROMIS projects Structure different: no network
projects (or we’re all network projects)
And one of the 12 PROMIS projects was ours! We’ll come back to this in a bit.
Outline
How did I come to this topic? Intro to PROMIS
How did my wife come to this topic? Intro to CNICS
PROMIS 2 research on depression PROMIS 2 network / Clinical Practice
Subcommittee Future forecast
Heidi Crane, MD MPH
UW undergrad, UW med school, Barnes-Jewish Medicine Residency, UW ID fellowship
K23 on body morphology disorder among people with HIV
Self-reported body morphology changes Tablets in the waiting room for people with
long waits ahead of them Other PRO domains on the assessment
Crane HM et al. Routine collection of patient-reported outcomes in an HIV clinic setting: the first 100 patients. Current HIV Research 2007; 5: 109-118)
Chart reviews for same-day visits
Depression: not identified by providers Substance use: not identified by providers Poor adherence: not identified by providers
And alarmingly high prevalence of patients who told the computer they were having problems, whose providers documented “No problems with adherence,” “Perfect adherence,” “Taking all meds”
Reviewed these findings with clinic leadership Imperative to measure these things and
make sure providers have access to the findings at the point of care
Integrating into routine care: not trivial Instead of patients with long anticipated wait
times for research protocol, change to all patients Except not all patients; super frequent fliers for wound
care excluded So who?
Offset the clinical day, so patients scheduled to interact with tablet 20 minutes before provider scheduled in the room Front desk implications, rooming staff / vitals
implications, … In short: a clinical change with an impact on
patient flow Importance of Clinic Leadership buy-in essential Other elements of case on succeeding slides
Source: http://www.improvingchroniccare.org/index.php?p=Chronic+Care+Model&s=124
Extension of Chronic Care Model
clinical information system, delivery system design, decision support “Listening to the patient’s voice in a
systematic standardized way” Delivering data to providers using 21st
century informatics tools Ultimate goals: Tailored, personalized,
evidence-based recommendations for clinical actions
Patient-provider relationship
Devote time during the clinic session to elements both patients and providers deem important
Clarify patient concerns Patients more honest to CASI than they are to a
provider, less social desirability bias. More likely to report to CASI poor adherence, substance abuse, depression, risk behavior than to provider Fredericksen R et al. Integrating a web-based, patient-
administered assessment into primary care for HIV-infected adults. Journal of AIDS and HIV Research
Figure 1A. Common situation in routine clinical care
Figure 1B. Situation with valid adherence measurement incorporated into clinical care
Poor adherence
Adherence not assessed
System not aware No
intervention
Continued poor adherence
Poor HIV outcomes
Structural barriers Provider barriers Patient barriers to assessment
Patient factors *substance abuse *mental illness *other
Poor adherence
Patient factors *substance abuse *mental illness *other
Adherence assessed
Intervention
Poor adherence
Good adherence
Better HIV outcomes
Adherence assessed
System aware
CNICS
Madison Clinic part of UW Centers for AIDS Research (CFAR)
CFARs banded together to form CNICS, the CFAR Network of Integrated Clinical Systems
Initial partnership with the 1919 Clinic at University of Alabama at Birmingham
http://www.positivethebook.com/
PROs at UAB
Paper free clinic Never a feedback form on paper Touch screens provider room with feedback; monitors
in exam rooms Aspects of PROs at every visit (ROS) Patient flow is different – patients in a physical
“circuit” around the clinic Patient flow at Madison was much more waiting room
-> vitals -> back to waiting room -> exam room Addressed the “circuit” with “ticket numbers” so
could pick up the PRO Assessment where they left off Addressed these differences with personal visits
PROs in CNICS
Extension to Fenway (Boston), UC San Diego (large Latino population; Spanish essential), others (UCSF, Hopkins, UNC, Case Western) Different EMR systems, different leadership /
clinic cultures, different patient groups, different patient flow
All PRO collection is local!
Our PROMIS 2 proposal CNICS infrastructure now with 30,000 PRO
Assessments from 8 CFARs around the country Extensive harmonized clinical data Uniquely situated in clinical care for PLWH Aim 1: PROMIS domains in clinical care
Ask patients which domains they think are most important
Focus on groups of items patients see, not the whole bank Simulated CAT, PROMIS short form As of April 2012, 809 studies set up in Assessment
Center; only 2 administered an entire bank
Other parts: 2 new domains; RCT on adherence; active involvement with the Network
Outline
How did I come to this topic? Intro to PROMIS
How did my wife come to this topic? Intro to CNICS
PROMIS 2 research on depression
PROMIS 2 network / Clinical Practice Subcommittee
Future forecast
Depression domain
Simulated CAT: 5 items for severe, moderate, and mild depression
Compared with short form content
Short Form CAT: Mild CAT: Moderate, Severe Sad Sad Sad Unhappy Unhappy Unhappy Depressed Depressed Depressed Helpless Helpless Hopeless Worthless Like a failure Nothing to look forward to Discouraged about future Discouraged about future Disappointed in self
Analyses of depression domain Qualitative analyses
97 PLWH in 4 cities, stratified by depression severity “Repetitive,” “Redundant,” “Mas o menos lo mismo”
(both the Short Form and each of the simulated CATs)
“What would a provider need to know to take great care of a person with HIV? SUICIDALITY
Providers: Distinct preference for PHQ-9 content Patients: Distinct preference for PHQ-9 content
Quantitative analyses 1299 PLWH in 4 cities PROMIS and PHQ-9 work fine, nothing to distinguish
either one
WSCD (“What Should CNICS Do”)?
• Administer PHQ-9, score using PROMIS item parameters Gibbons LE et al. Migrating from a legacy
fixed-format measure to CAT administration: calibrating the PHQ-9 to the PROMIS depression measures. Qual Life Res 2011; 1349-1357.
Best of both worlds Content providers and patients want,
scores on PROMIS metric, brief enough
Outline
How did I come to this topic? Intro to PROMIS
How did my wife come to this topic? Intro to CNICS
PROMIS 2 research on depression PROMIS 2 network / Clinical
Practice Subcommittee Future forecast
PROMIS Clinical Practice Subcommittee
Growing demand for PROMIS scales from clinicians Groundswell of understanding of need for PROMIS
focus on this issue “Sorry, I have to go, there goes my group, and I am
their leader!” Big initiatives to date: two papers (Broderick et al.
2013; Jensen et al. to be re-submitted) and EPIC Steering Committee vote: Work with EPIC to
ensure PROMIS content included Extensive discussion of which domains and
calibrations Initial build: short forms, scored using total scores
(not IRT scoring) Hopefully CATs in next build
PROMIS 2 Network
Large number of additional domains being developed (sexual function, self efficacy, substance use, GI symptoms)
Bigger efforts in pediatric settings (Cincinnati Children’s, CHOP, UNC)
Other initiatives: cancer, instantaneous assessment, broaden physical functioning to address ceiling, …
Less cohesive than PROMIS 1 (by design) in terms of projects
PROMIS standards document, domain framework, PROMIS at NIH Clinical Center, PROMIS in National Children’s Study, PROMIS in DoD care settings, ….
3 Coordinating Centers transitioning to ??? In future PROMIS, NIH Toolbox, NeuroQOL
RFA-CA-13-008 The purpose … is to support the creation of a research resource
infrastructure for the administration of research investigations using person-centered health outcomes … the Person-Centered Outcomes Research Resource (PCORR).
The PCORR will be expected to support the use and enhancement of the following four measurement information systems, currently funded as separate NIH programs: Patient Reported Outcomes Measurement Information System® (PROMIS®); the NIH Toolbox for Assessment of Neurological and Behavioral Function (NIH
Toolbox); the Quality of Life (QOL) Outcomes in Neurological Disorders (Neuro-QOL; and The Adult Sickle Cell Quality of Life Measurement Information System
(ASCQ-Mef). The main goal for the PCORR is to provide an integrated platform for
automated use of the four measurement information systems. This platform must be compatible with various modes of information
collection (including web/mobile-based entry, non-digital paper source data, and others).
The PCORR platform must also be designed to allow resource users (i.e., external researchers and clinicians unaffiliated with the resource) to access and use any of the four systems together or in isolation and tailor use to meet the specific study needs…
PCORI funding
Not surprising PCORI is interested in PROs Their default is that patients are the
experts Atlanta meeting last fall on
integrating PROs in EHRs PROMIS measurement RFP now Additional input on PCORI priorities
sought Additional funding initiatives likely
Network-ness
Outline
How did I come to this topic? Intro to PROMIS
How did my wife come to this topic? Intro to CNICS
PROMIS 2 research on depression PROMIS 2 network / Clinical Practice
Subcommittee Future forecast
“Prediction is very difficult, especially about the future” (N Bohr / Y Berra)
Growing demand for PROs in clinical care ACOs, PCORI, Quality measures, IOM,
Meaningful use…. Technological issues much less of a
barrier Ubiquitous tablets and iPhones Initiatives such as PROMIS developing a lot of
content Where should this head?
42
University of Utah Orthopedics
PROMIS colleague Nan Rothrock got me connected with Orthopedics faculty at U of Utah
Discussion with Dr. Darrel Brodke Chair interested in PRO collection x
years ODI, NDI, SF-36, PROMIS PF, EQ5D Floor effects of ODI and NDI Data warehouse, also scores at point
of care
Score interpretability
Clinicians are not innumerate people! mmHg, HCT, chemistries, creatinine,
saturations, SNPs, omics, MRI physics… How do we get used to all these
numbers and different scales? The old fashioned way – we use them!
Black box of score production Modern psychometrics, confirmatory
factor analysis, item response theory, graded response model, polytomous data, computerized adaptive testing, etc. There’s a whole science in there! But there is a whole science in producing the
creatinine value we use clinically too, and I don’t know what’s in that black box
I don’t think one needs expertise inside the black box to use the output from the black box to take great care of patients
Future will be longitudinal Power will come from integrating
PRO data alongside other clinical data
Conceptualize PRO collection as an extension of history taking Quantified history?
Not the end of the discussion but a launching point Launch from a deeper place than “So
how’s your depression been doing?”
Imagine this visit…
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Next things to tackle
One size fits all Great place to start Heterogeneity across patients within a clinical
setting Primary care may be the hardest
Critical need to value patients’ time – can’t possibly collect everything on everyone
Measurement prior to visits vs. web-based More and more people are connected Critically important to reach those who are not!
Lessons learned
Patient care is local Stakeholder buy-in is critical for clinical change
to survive Patients appreciate being asked The only way to study the data is to have the
data Old questions of whether what we do makes a
difference 21st century technology to address those questions
Personalized care is not just omics, it’s got a person at the center Patient-provider relationship at the center of the
Chronic Care Model makes a ton of sense!
Too many great colleagues to thank
Thanks for the invitation! Thanks to Joan Broderick and other PROMIS Clinical
Practice Subcommittee authors on the eGEMS paper, which caught your eye and led to my talk today
UW/Madison Clinic Colleagues UW PROMIS Colleagues CNICS investigators Dagmar Amtmann and PROMIS 1 Gerald van Belle, Dan Mungas, Eric Larson, Ed
Wagner for mentorship My local shop: Laura Gibbons, Shubhabrata
Mukherjee, Elizabeth Sanders Funding from NIH Patients