3 The NIH seeks proposals for innovative approaches to measuring patient-reported outcomes (PROs). . . across a wide variety of chronic disorders and diseases.Develop and test a large bank of items measuring PROsCreate a computerized adaptive testing system that will allow for efficient, psychometrically robust assessment of PROsNIH Roadmap, 2003$100 million invested to date
4 Develop unified/integrated of multiple indicators (cognitive, emotional, motor, sensory) of neural and behavioral health functioning for use in large cohort studies and clinical trialsCould be used as a form of “common currency” across diverse study designs and populationsWould maximize yield from large, expensive studies with minimal increment in subject burden and costNIH Neuroscience Blueprint, 2006$40 million invested to date
5 Clinician/researchers wanted measures which were: Psychometrically soundBrief, easy to useIntellectual Property “Free”Applicable in variety of settingsand with different subgroupsAvailable in multiple languages
6 As well as measures which: Cover the full range of a traitNo Floor EffectNo Ceiling EffectAvailable for use across the age span
7 Further, all of the NIH Systems Drive to Utilize a Common Metric The same instrument used for many diseasesThe same “scale” applicable to all instruments/diseasesThe same scale regardless of instrument format:Single itemShort FormLong FormComputerized Adaptive Test (CAT)
8 BUT most legacy measures failed to make the grade: Psychometrically sound NOT ALWAYSBrief, easy to use RARELYIntellectual Property “Free” NOT ALWAYSApplicable in variety of settings SOMETIMESand with different subgroups RARELYAvailable in multiple languages SOMETIMES,(and if so, rarely with the same meaning!)
9 Neither can most legacy measures: Cover the full range of a trait ALMOST NEVERNo Floor Effect SOMETIMESNo Ceiling Effect NEVER?Available for use across the age span RARELY
10 Nor do legacy instruments have: The same instrument used for many diseases RARELYThe same “scale” applicable to all instruments/diseases NEVERThe same scale regardless of instrument format: NOPE!Single itemShort FormLong FormComputerized Adaptive Test (CAT)
11 More on the ceiling issue Legacy measures can fail to identify treatment success, nor do they typically accurately assess anyone above the mean!
12 It is impractical to use disease specific instruments
13 And often patients don’t want to settle for “average”function Previously physically active patients, who are now recovering from an accident, don’t want to be considered “cured” because the instrument used to assess their physical functioning “ceilings” at the 50% ileAthletes and others in physically active roles need to accurately differentiate very high levels of functioningA cancer patient whose fatigue instrument shows them to be “above” the clinically relevant range assessed by a typical instrument– may be far away from from feeling “normal.”
14 Many Instrument Types CAT Short Form Scale Mode Precision Brevity ComputerComputer and paperPrecisionHigh for all trait levelsVaries by length and how well the form is targeted to the specific subjectBrevityVariable length (4 – 12 items)Range of lengths availableInstrument Dependent
15 NIH Measures can also be compared to legacy measures A common problem when using a variety of patient-reported outcome measures is the comparability of scales on which the outcomes are reported. Linking establishes relationships between scores on two different measures.The PRO Rosetta Stone (PROsetta Stone®) developed and applied methods to PROMIS and other PCORR instruments with other related instruments (e.g., SF-36, Brief Pain Inventory, CES-D, MASQ, FACIT-Fatigue) to expand the range of PRO assessment options within a common, standardized metric. It provides equivalent scores for different scales that measure the same health outcome.
18 The Patient Reported Outcomes Measurement Information System Tools40 Adult Measures; 20 Pediatric MeasuresDiseasesNon-Disease SpecificValidated in Many DiseasesAdvancing Knowledge>100 Peer-ReviewedPublicationsCooperative Group12 Research Sites3 Centers150+ ScientistsTranslationsAll item banks SpanishIndividual Banks and Instruments in Many Languages
19 Domain Framework Symptoms Physical Health Function Affect Self-Reported HealthMental HealthBehaviorCognitionGlobal HealthRelationshipsSocialHealthFunction
22 PROMIS Basic (Profile Banks) Social HealthPROMIS Basic (Profile Banks)Satisfaction with Participation in Social RolesPROMIS PlusSatisfaction with Social Roles & ActivitiesAbility to Participate in Social Roles & ActivitiesSocial SupportSocial IsolationCompanionshipExtrasPeer RelationshipsEmotional SupportInformational Support
23 Pediatrics Physical Health Pain Behavior, Quality, Intensity Physical ActivityMental HealthExperience of StressSubjective Well-beingSocial HealthImpact of Child Illness on FamilyFamily BelongingnessGlobal Health
24 The NIH Toolbox for the Assessment of Neurological and Behavioral Function ToolsFour 30-minute domain-level batteriesfully normed for ages 3-85108 Instruments in totalAdvancing Knowledge54 Peer-ReviewedPublicationsDiseasesNon-Disease SpecificValidated for use in growing number of diseasesContract Mechanism80 Institutions256 Scientists & Staff20,000 SubjectsTranslationsAll instruments Spanish
26 Instrument Selection Expert Survey of selection criteria (N=152; NIH top epidemiologists/researchers)Focus group interviews with patientsExpert Interviews (44 interviews)Surveys to nominate and rank sub-domains and constructs
28 Many of these measures already ARE being used in EHR’s 2012 – EPIC enables PROMIS short forms2014 – EPIC in the process of enabling PROMIS CATs2014 – The Department of Defense EHR using CATsNow: Walter ReedSpring: Balboa and Madigan
29 Do we have time for more examples? The Department of Defense – this week made PROMIS the priority outcome system for choice for 13,000,000 patientsCleveland ClinicAO Foundation (3,000 Orthopedic Trauma Surgeons)The National Children’s Study (N=105,000, 25 years+)Selected a wide range of PROMIS and NIH Toolbox instruments – for Parents, for Parents as Proxies for their Children, and for the Children themselves
30 Measures for Social and Behavioral Determinants of Health The view provided by two large National Institutes of Health sponsored development effortsRichard C. Gershon, PhD.Northwestern University
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