3/5/2014. New Research Initiatives to Improve QoL of Persons with SCI Across the Globe. What Are the SCI International Datasets?

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Kathlyn Sutton
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New Research Initiatives to Improve QoL of Persons with SCI Across the Globe International SCI Conference: Toward Better Quality of Life Sultan Bin Abdulaziz Humanitarian City Riyadh, KSA Tamara

1 New Research Initiatives to Improve QoL of Persons with SCI Across the Globe International SCI Conference: Toward Better Quality of Life Sultan Bin Abdulaziz Humanitarian City Riyadh, KSA Tamara Bushnik, PhD, FACRM March 4-6, 2014 CLINICAL RESEARCH Presentation Title Goes Here 2 What Are the SCI International Datasets? International SCI Data Sets Basic Data Sets to be used during daily clinical practice Spinal Cord Injury Spinal Interventions and Surgical Procedures Non-traumatic SCI Lower Urinary Tract Urinary Tract function Urodynamic Urinary Tract Imaging Bowel Skin and Thermoregulation Quality of Life Female Sexual and Reproductive Male Sexual Musculoskeletal Upper Extremity Pain Cardiovascular Pulmonary Endocrine and Metabolic Activity and Participation 3 Presentation Title Goes Here 4 1

SCI Basic Variables Using the International SCI Data Sets Subgroup: Spinal Cord Injury CDEs Recommendations: These instruments and elements are recommended for use in all disease studies: Each data

2 SCI Basic Variables Using the International SCI Data Sets Subgroup: Spinal Cord Injury CDEs Recommendations: These instruments and elements are recommended for use in all disease studies: Each data set has a detailed syllabus that describes each variable, permitted values/responses/ranges Avoid changes to interpretations from the syllabus for each data set Assess the test cases (where available) as a training tool Core Instruments: N/A 5 Translating the Data Sets Basic Principles Translating the Data Sets Procedure All text, scoring guidelines, data collection form and training cases should be included Cultural adaptation as necessary Construct being measured may not have the same meaning or same role in the target culture Cultural equivalence vs. verbatim translation Medical/clinical issues may be more universal than concepts such as QoL, participation Communication with chair of original Data Set working group to resolve cross-cultural barriers Translate from English to target language; back-translation to confirm original meanings maintained Translation performed by experts in SCI 2 independent translations for comparison Back-translation by linguistic expert(s) familiar with medical English Blinded to original English version Independent of the original translators Translation checked for fidelity to original data elements, guidelines and test cases May need to re-establish reliability in target language 2

3 Summary Validity fairly well-established Reliability testing is needed Translations encouraged The Data Sets are not static change is appropriate when needed Maintain communication with the Executive Committee of the International SCI Data Sets Focus is on clinical utility at the moment Extended data sets are being developed for primarily research use RESEARCH CLINICAL Presentation Title Goes Here 10 Objectives of PROMIS/Neuro-QOL/TBI-QOL Patient Reported Outcome Measurement Information System (PROMIS) Develop and test large item banks measuring patient-reported outcomes (PROs) Focus on a wide range of domains of functioning Create a computerized adaptive testing (CAT) system for efficient, psychometrically robust assessment Create a publicly available item repository and CAT platform that can be accessed by the public 12 3

PROMIS II PROMIS Domain Framework Physical Symptoms Self-Reported Mental Affect Behavior Cognition 13 Social Relationships PROMIS Current Physical Banks PROMIS Current Mental Banks Adult Pediatric

4 PROMIS II PROMIS Domain Framework Physical Symptoms Self-Reported Mental Affect Behavior Cognition 13 Social Relationships PROMIS Current Physical Banks PROMIS Current Mental Banks Adult Pediatric Adult Pediatric Pain Behavior Anxiety Anxiety Pain Interference Pain Interference Depression Depression Physical Fatigue Physical Sleep Disturbance Fatigue Upper Extremity Mobility Mental Anger Illness Impact Negative Illness Impact Positive Anger Sleep-related Impairment Asthma Impact Applied Cognition - Concerns Sexual Applied Cognition - Abilities 4

5 PROMIS Current Social Banks Need for a New Tool in Neurological Disorders Social Adult Ability to Participate in Roles & Activities Satisfaction with Roles & Activities Companionship Emotional Support Informational Support Instrumental Support Pediatric Peer Relationships Many Disorders Multitude of generic and targeted measurement instruments Many not validated for use in clinical trials Unresponsive to differences that exist across different conditions or treatments Limited by floor and ceiling effects Respondent burden Research cost Lack of consensus about best measurement approaches Social Isolation Broad Objectives of Neuro-QOL Develop a core set of questions that cut across chronic neurological disorders Develop supplemental questions that address additional concerns of specific diseases, subgroups of patients Create a publicly available, adaptable and sustainable system allowing clinical researchers access to a common item repository and CAT Target Disorders Adult conditions Stroke Multiple Sclerosis Parkinson s disease Epilepsy ALS Spinal Cord Injury Traumatic Brain Injury Pediatric conditions Epilepsy Muscular dystrophies 5

6 Neuro-QOL What about SCI? Neuro-QOL may become the expected outcome variable in clinical trails research with patients who have neurological disorders. Many aspects of Neuro-QOL will likely be inappropriate (e.g., lacking sensitivity and specificity) for individuals who have experienced a traumatic injury. Will not cover core issues in SCI or TBI patients: wheelchair mobility, secondary complications, traumatic nature of injury/disability. Emotional well-being - Coping - Distress - Enjoyment Quality of life Dimensions Physical well-being - Symptoms - Treatment side effects - Mobility / ADLs Quality of life Social well-being - Social Activity / Support - Relationship Quality - Family well-being Cognitive wellbeing - Executive - Attention / Concentration - Memory 23 Slide Courtesy of David Cella Emotional well-being - Coping - Distress - Enjoyment Quality of life Dimensions Physical well-being - Symptoms - Treatment side effects - Mobility / ADLs Quality of life Social well-being - Social Activity / Support - Relationship Quality - Family well-being Physical al (SCI-CAT) Physical-Medical (SCI-QOL) Cognitive wellbeing - Executive - Attention / Concentration - Memory 24 Slide Courtesy of David Cella 6

Pilot Studies Interviews with individuals with SCI Semi-structured interview with patients. Identify (a minimum of) 15 issues that were important.

7 Pilot Studies Interviews with individuals with SCI Semi-structured interview with patients. Identify (a minimum of) 15 issues that were important. SCI-CAT Domain Structure GENERAL TASKS AND DEMANDS ACTIVITY LIMITATION COMMUNICATION Tell me what is important to your Quality of Life MOBILITY SELF-CARE DOMESTIC LIFE SEXUAL ACTIVITY 26 Ultimate Goals SCI-QOL/SCI-CAT/TBI-QOL Partnership with Neuro-QOL team to develop and calibrate item banks for other aspects of HRQOL and NINDS 4 Spinal Cord Injury Model System centers RIC U of Michigan U of Washington KMRREC/KIR Bronx VA 7

8 SCI Banks NEW PROMIS Neuro-QOL Bladder Mgmt. Diff Pain Interference Positive Affect & WB Bowel Mgmt. Diff Depression Stigma Skin/Pressure Ulcers Anxiety Ability to Participate Resilience Physical? Sat w Participation Self-Evaluation Grief-Loss Psych. Trauma Basic Mobility Wheelchair Mobility Ambulation Fine Motor Self Care Developing Item Banks to Ensure Consistency with PROMIS/Neuro-QOL SCI-QOL Domain Item Bank Linking Instrument # Items in Final Calibration # of Possible Anchors Emotional Depression PROMIS Emotional Anxiety PROMIS Emotional Positive Affect and Well Being NeuroQoL Phys-Med Pain Interference PROMIS Social Ability to Participate in Social Roles and Activities NeuroQoL Social Satisfaction with SRA NeuroQoL Social Stigma NeuroQoL Funding Sources PROMIS II: NIH Grant # 1U01AR Neuro-QOL: HHSN Contract # SCI-FI: NIDRR Grant # H133N060022, H133N060024, H133N060005, H133N060014, H133N060027, H133N SCI-QOL: NIH Grant # 5R01HD TBI-QOL: NIDRR Grant # H122G TBI Model System: NIDRR Grant # H133A070037, H133A080045, H133A070038, H133A &D Grant #B6237R Thank You Thanks to the following individuals who provided content for this presentation: David Tulsky, PhD Pamela Kisala, PhD Susie Charlifue, PhD Fin Biering-Sorenson, MD, PhD Presentation Title Goes Here 32 8

Instruments Available for Use in Assessment Center

Instruments Available for Use in Assessment Center The Assessment Center Instrument Library includes instruments from PROMIS, Neuro-QoL, NIH Toolbox and Health LiTT. All instruments are available for use