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Neuro-QOL

Quality of Life in Neurological Disorders

Study

This project has been funded in whole or in part with Federal funds from the National Institute of Neurological Disorders and Stroke, National Institutes of

Health, under Contract No. HHS-N 265-2004-236-01-C

Neuro-QOL is a 5-year, multi-site National Institute of Neu-rological Disorders and Stroke (NINDS) funded project to

develop health-related quality of life (HRQL) assessment tool for adults and children with common neurological disorders. These tools are intended to be responsive to the needs of clinical researchers and facilitate comparison of results across clinical trials in dif-ferent diseases. To accomplish this, we proposed to develop, modify, and test item banks, or finite sets of questions, that are designed to assess common concepts that cut across virtually all selected diseases. We further proposed to add to these generic item banks separate sets of unique, targeted scales to evaluate symptoms, concerns or issues that are relevant only to a subset of diseases or treat-ments. The primary end users of this measurement system will be clinical trialists and other clinical neurology researchers; however the item banks should also be appropriate for clinical practice. The approach we have taken is unique and innovative in its combination of traditional and more modern (Item Response Theory - IRT) scale construction and validation methods. Terms such as “generic” and “disease specific,” are typically used to designate the distinction between HRQL concepts that are common versus unique across conditions, respectively. This distinction has been manifest in two types of static questionnaires: Generic ones that are administered to all patients across conditions, and disease-specific (or targeted) ones that are administered only to patients with a given condition. The former set tends to emphasize self-reported function and well-being; the lat-ter set tends to emphasize disease symptoms. This is inefficient and suboptimal for communication and interpretation of results from clinical research. It is inefficient because: a) it results in instru-ment-based requirements to ask more questions than are relevant in a given research setting; and b) it ties one to the same set of questions to measure a given concept, even though a different set might be preferred in one disease versus another. It is suboptimal because it discourages the user from selecting important HRQL concepts and focusing on them. Our evolving model of self-reported health status, informed by our experience in scale construction and validation, and enabled by IRT, allows us to re-think this conventional dichotomy and instead propose that there are indeed common symptoms and HRQL concerns across sets of neurological conditions, and unique symptoms and concerns relevant only to a very small subset of diseases. This common/unique distinction, while related to the generic/specific dichotomy, allows considerably more flexibility in execution for the end-user. For example, a user can select only one concept to measure in a trial, or s/he can select 10 or perhaps more, depending upon the scope of the research question. In every case, the scoring and interpretation of the results can be standardized across and within diseases, even when different questions are selected within a concept item bank. We envi-sion and can accomplish the development and validation of a finite set of common “item banks,” or sets of questions that together measure underlying concepts of self-reported health, including some symptoms. Grounded in the research literature and endorsed by the neurology research community, these banks will enable a psychometrically-sound “shopping cart” approach to selecting the optimal assessment of HRQL concepts. Reported results will be interpretable across the field, as each com-pilation of bank items will provide an IRT-driven estimate of the patient’s level on each measured concept. (Cont’d Back Page)

The aim of this study is to devel-op a core set of questions that will address dimen-sions of Health-Related Quality of Life (HRQL) that are universal to patients with chronic neurologi-cal diseases.

We will also devel-op supplemental questions or mod-ules that address additional HRQL concerns that are specific to par-ticular groups of patients defined by disease, age, or other factors.

Message from the Principal Investigator

David Cella, PhD, Center on Outcomes, Research

and Education, ENH

Quality of Life Outcomes in Neurological Disorders

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Advancing the State of PROs in Neurology

- an NINDS Initiative

The National Institute of Neurological Disorders and Stroke (NINDS) clinical research program has been established to support all clinical studies of the neu-

rological disorders and to support development of scientific methodology to advance clinical research in neurology. In support of its mission, NINDS conducts, fosters, coordinates, and guides research on the causes, prevention, diagnosis, and treatment of neurological disorders and stroke, and supports basic research in related scientific areas. A key component of the clini-cal research agenda is conduct of clinical trials to evaluate potential intervention and preven-tion strategies for neurological disorders. Evaluation of these strategies depends on defining and measuring appropriate outcome variables. Typically, these variables comprise clinical or functional outcomes (such as death, recurrence of stroke, seizure frequency, muscle strength measures, etc.). Many of these traditional clinical or functional measures of disease status do not adequately represent the full scope of the impact of disease on an individual with a chronic neurological disorder. More subjective components of patients’ functioning, such as social, psychological, and mental well-being, may be more important components of disease impact. Measurement of patient-oriented outcomes is a particular concern in clinical trials, where small

differences in clinical measurements or imaging results may not translate into important benefit to the patients. These measures are essential in order to provide the full picture of the effect of intervention on patients.

Some aspects of health-related quality of life have been incorporated into many recent or current clinical trials in neurology, usually as secondary outcome measures. Many measurement scales have been developed for use in various disease settings; however, some of the existing scales have questionable validity and there is no consen-sus on what methods should be used within or across

studies or disease areas. The lack of consensus about the best tools or approaches makes it difficult to compare the relative burden of various neurological conditions to each other, or more importantly, to compare the relative benefits of one treatment over another on the same patient-centered outcome. Additionally, there is a paucity of condition-targeted quality of life surveys for persons with neurological diseases that are reliable, valid, responsive, and are brief enough to be feasibly administered in the clinical trials setting.

In response to these concerns, in September, 2004, NINDS awarded a contract to the Center on Outcomes, Research and Education (CORE), ENH Research Institute, to develop a coordinated approach to defining and measuring quality of life in neurological disorders. Creat-ing such a tool for persons with neurological diseases will greatly increase the probability that the research community will incorporate patient-centered measures as primary and secondary outcomes in clinical trials.

The mission of the National

Institute of Neurological Disorders and Stroke (NINDS) is to reduce the

burden of neurological disease - a burden borne by every age

group, by every segment of soci-ety, by people all over the world.

Patient-Rep

ortedClaudia Moy, PhD,

NINDS

Outcom

esMessage from the

Project Officer

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Crit

eria

for

Acc

epta

nce

Since its kickoff in the fall of 2004, the Neuro-QOL project has accomplished several im-portant milestones. Using a comprehensive methodology involving qualitative and quanti-

tative approaches, we have:

• Learned critical criteria for the acceptance of a new patient reported outcome measure in neurology through numerous expert interviews • Selected 5 adult and 2 pediatric neurological conditions for which we will field test our measure • Selected domains and sub-domains for which generic item banks and disease targeted scales will be developed • Developed an item library containing over 3,000 generic and disease specific items • Created item pools reflecting generic and targeted concepts • Translated items into Spanish using a rigorous translation methodology

Criteria for Acceptance of a New Patient Reported Outcome Measure in Neurology Cindy Nowinski, MD, PhD, Center on Outcomes, Research and Education, ENH

We requested information from physicians and other professionals (n=89) who participate in clinical neurology research regarding their attitudes toward,

knowledge about and use of HRQL information and measures. The primary goal of this effort was to identify factors related to the acceptance of HRQL measures in the neurology clinical trials community that can be used to maximize the likelihood that the Neuro-QOL measure-ment system will be met with widespread receptiveness among its expected users. Qualitative analysis indicated that satisfactory psychometric properties, ease of administration and use, content that captures the diversity of symptoms and HRQL impact associated with neurologi-cal disease, and clinical relevance and utility are seen as important criteria for HRQL measure acceptance. Quantitative results demonstrated that enthusiasm and reluctance toward HRQL are associated with specific beliefs and behaviors. Respondents were more enthusiastic if they saw clinical utility in HRQL findings and actually used these findings to change their practice. In contrast, respondents who were more reluctant to embrace HRQL preferred clinical care over HRQL issues, lacked knowledge about HRQL or thought that HRQL was defined too vaguely to be useful.

Our team will utilize these findings in order to maximize the Neuro-QOL measure’s accept-ability to the neurology research community. Later sections in this progress report describe methods we have used to ensure that criteria identified as important by respondents, such as ease of use and appropriate content, are incorporated into our new instrument. We also plan targeted efforts to engage enthusiastic and reluctant groups. To sustain those who have en-thusiasm toward HRQL, for example, we will provide up-to-date HRQL research findings and evidence that HRQL measures are clinically relevant. To engage reluctant individuals we will provide meaningful conceptualizations of HRQL and evidence for the value of HRQL in clinical care. We anticipate that such efforts will facilitate the adoption of the Neuro-QOL measure by the neurology clinical research community.

Accomplishments and Milestones

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Conditions With Likely Onset In Childhood And Adolescence Attention Deficit Hyperactivity Disorder Autism Cerebral Palsy Duchenne Muscular Dystrophy Epilepsy Primary Brain Tumors Conditions With Likely Onset In Adolescence And Early Adulthood Narcolepsy Spinal Cord Injury Traumatic Brain Injury

Conditions With Likely Onset In Early And Middle Adulthood Complex Regional Pain Syndrome Epilepsy Migraine Headache Multiple Sclerosis Conditions With Likely Onset In Middle And Late Adulthood Amyotrophic Lateral Sclerosis Alzheimer’s Disease Chronic Pain Syndrome Diabetic Peripheral Neuropathy Hereditary Motor-sensory Neuropathy Huntington’s Disease Idiopathic Peripheral Neuropathy Parkinson’s Disease Primary Brain Tumors Stroke

Major Neurological Conditions Identified in the Literature Review

Selection of Neurological Conditions Amy Peterman, Ph.D. , Department of Psychology, UNC–Charlotte

Initially, we identified conditions through completing an extensive Medline liter-ature review of 24 neurological conditions using key words such as health-related quality of life (HRQL), neurological disorders, measurement issues, as well as disease-specific characteristics, from 1996 to the present. This literature review summarized major neurological disorders and their concomitant impact on HRQL. Beginning with those typical to childhood onset followed by those most common in adults and advancing age, major neurological conditions included:

Literature Review

s

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In addition, we conducted interviews with 44 experts in neurological disorders and/or health related quality of life (HRQL). The expert interviewees were asked to identify the five neurological disorders for which they felt it was most important to measure HRQL. They were not asked to specify whether they were nominating adult or pediatric diseases. Table 1 lists the disorders and the number of nominations they received from the expert interviewees.

Table 1. Disorders Selected by Expert Interviewees (N=44)

Stroke 35 SCI 12

Multiple Sclerosis 33 ALS 10

Parkinson’s Disease 27 CNS tumor 7

Epilepsy/seizure 24 Pain disorders 5

AD/Dementias 17 Neurodegenerative 5

TBI 16 Sleep disorders 4

Migraine 13 Neuropathies 4

A consensus panel of 13 renowned experts in neurology was convened for the purpose of selecting five adult and two pediatric neurological disorders to be the focus of subsequent HRQL measure development activities. Prior to selecting the target diseases, the consensus panel agreed to use the following criteria when making their decision:

1. Prevalence of the disease/disorder 2. Magnitude of the disease’s impact on the individual 3. The existence of promising current or new treatments on the horizon 4. Multiple domains affected 5. Chronic nature of the disease/possibility of seeing HRQL change

In contrast to expert interviewees, consensus panel members were asked to select five adult and two pediatric diseases separately. The results of this process (with number of votes) are presented in Table 2.

Table 2. Adult and Pediatric Diseases Selected by Consensus Panel

ADULT PEDIATRIC

Stroke 13 Epilepsy 9

Multiple Sclerosis 12 Muscular Dystrophy 7

Parkinson’s Disease 11 Cerebral Palsy 4

Alzheimer’s Disease 10

Migraine Headache 7

Spinal Cord Injury 6

Epilepsy 5

Traumatic Brain Injury 1

6

Pati

ent

& E

xper

t In

put

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Final Recommendations

After consideration of expert and consensus meeting findings, as well as discussions with members of the NINDS, the Neuro-QOL Executive Committee finalized this list of adult and pediatric conditions (see Table 3), which included: 1) Adult Conditions - Stroke, Multiple Sclerosis, Parkin-son’s Disease, Epilepsy and Neuromuscular Disorders (which has been defined as Amyotrophic Lateral Sclerosis and Myasthenia Gravis); 2) Pediatric Conditions – Epilepsy and Muscular Dys-trophies.

Selection of Domains and Sub-Domains David Victorson PhD, Center on Outcomes, Research and Education, ENH We identified domains through mul-tiple methods and data sources. Initially,

we identified domains through completing an extensive literature review of 24 neurological conditions from 1996 to the present (previously described). From this review, our initial list of domains included: emotional distress, perceived cognitive functioning, social func-tioning, physical functioning, fatigue, pain, communica-tion/language difficulty, positive psychological func-tioning, sexual functioning, bowel/bladder function, sleep disturbance and personality/behavioral changes. Using each domain and Neuro-QOL disease as search terms, we identified the number of published studies in a given area to provide an estimate of how important certain domains were within different neurological conditions. We also conducted two separate waves of ex-pert interviews (n=44 and n=63) and an online expert request for information (n=89) to identify important domains that are affected by neurological disorders

and their treatments. Finally, we con-ducted 11 focus groups with patients and caregivers (seven with patients (n=64); four with caregivers (n=19)) to assess the impact of neurological conditions on health related quality of life (HRQL) domains. We began with broad questions, allowing participants to free-list responses on their definition of HRQL. We then progressed to ques-tions regarding specific HRQL domains, such as physical functioning, emotional functioning, social aspects, and treat-ment effects that have been shown to be relevant in the literature. Focus groups with caregivers of Alzheimer’s Disease, stroke, and pediatric epilepsy patients were conducted as these patients may be unable to reliably report their subjective perceptions of HRQL due to cognitive impairment or age. The following con-ceptual domain framework is the synthe-sis of these data sources: See side bar

Framework of Item Bank/Scales to be Developed

and Tested

PHYSICALFunction/ Health

Mobility/Ambula-tionSelf-Care / Upper Extremity

Symptoms

Sleep DisturbanceFatiguePainPersonality/ Behavior Change

MENTALEmotional Health

Anxiety/FearDepressionStigmaPositive Psychologi-cal Function

Cognitive Health

Perceived DeficitsApplied Cognition

SOCIAL

Role Performance

Role Satisfaction

•

•

••••

••••

••

Table 3. Final Recommendations Adult ConditionsStrokeMultiple SclerosisParkinson’s disease

Epilepsy

Neuromuscular Disorders (Amyotrophic Lateral Sclerosis and Myasthenia Gravis)

Pediatric ConditionsEpilepsy

Muscular dystrophies

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Selection of Development Items Deborah Miller, PhD, Depart-ment of Neurology, The Cleve-land Clinic

Instruments and items were identified by Neu-ro-QOL investigators and expert consultants by literature searches and previous item banking projects, which were delivered to a centralized Neuro-QOL Item Library. Over 3,000 items were entered into the Neuro-QOL Item Library according their elements such as item order, context, time frame, item stem and response set. Once the Neuro-QOL item library was populated, items were assigned to the Neuro-QOL domains through an iterative, multi-step process involving at least three domain experts. Two independent raters worked collaboratively to bin items to primary domains followed by agreement and reconciliation by a 3rd reviewer to ensure consistency across domains. As the number of items (many redundant) that existed in the library was large, all items were reviewed to determine if they should proceed through detailed item review/revision/testing and were grouped together according to each domain’s hierarchy of sub-domains, factors, and facets.

Content experts then systematically removed (“winnowed” )items from item pools. The fol-lowing exclusion criteria were used: semantic redundancy, availability of a superior alternative, inconsistency with domain definition, wrong do-main assignment, vague or confusing language, cultural/translation relevance, gender inappro-priate, too narrow or too disease specific.

Item Identification and Selection Process

Items selected from winnowing underwent a more thorough review done collaboratively by two domain co-chairs and several outside content experts. Most items needed revision for general consistency across banks. Re-writing or generating new items was done to assure comprehensiveness in measuring the domain; clear, understandable and precise language to experts and respondents; ame-nable to linguistic translation; and adapted to the data collection and analysis strategies planned. Findings from individual cognitive interviews and dataset analyses were provid-ed to content groups to integrate into deci-sion making. During this process, PROMIS and Activity Measure for Prostate Acute Care (AM-PAC) items were compared with Neuro-QOL items and redundancy was eliminated. Final item pools were reviewed by patients with the Neuro-QOL conditions (n=63) during telephone-based cognitive interviews in English and Spanish to assess the content validity of items, clarify concepts, refine language and response options. Dur-ing interviews patients reviewed each item in a one-on-one semi-structured interview focused on item comprehension and rel-evance. Patients and experts also identified areas (gaps in domain) for new item devel-opment and creation, to which new items were written or revised. See Figure 2 for an overview of the item identification and selec-tion process.

Conducted literature review to

identify items reflecting

Neuro-QOL content

Examined external, large datasets with

items and instruments

reflecting Neuro-QOL conditions &

domains

Items set in standardized format with preliminary

domain assignments were entered into the

Neuro-QOL Item Library

Items sent to content experts in Neuro-QOL domains to review (Ex-

pert Item Review)

Domain content experts sorted items into sub-

domains (binning), and then reviewed items to select those that would

undergo qualitative item review (winnowing)

Patient input received on comprehen-sibility and relevance of

all domains & item content

areas via individual cognitive

interviews

Criteria were established to evaluate and rewrite items

Results from cognitive

interviews & dataset analy-ses returned to domain

groups

PROMIS and BU items

compared and recon-ciled with

Neuro-QOL domains & items; new

items added, redundant eliminated

Neuro-QOL domain teams

trained on item review

process

Content & translation

experts and domain

teams review, rewrite, and

evaluate each item (Expert Item Review)

Results used to draft new

items and further revise existing items

Experts review of new

items

Final item pool devel-oped: Items

ready for testing

In-sert

Bank and scale items are currently being translated into Spanish using the Functional Assessment of Chronic Illness in Therapy (FACIT) translation methodology. Prior to beginning translation, item definitions are developed to clarify the concept that each item is intended to measure and identify any potential translation issues and suggested resolu-tions. Two native Spanish-speakers from different countries of origin translate the items independently, then a third native Spanish speaker from a third country of origin reconciles the translations; the recon-ciled version is back-translated by a native English speaking translator who is blind to the original source English version; CORE translation staff compare the source and the back-translated English versions to assess conceptual equivalence; three bilingual experts select the most appropriate translation for each item based on the previous steps or provide alternate translations when necessary; following resolution of reviewer suggestion, the Spanish items are formatted, then proofread by two independent proof-readers working simultaneously. The final Spanish version is cognitively debriefed with a sample of 30 Spanish-speaking adult and 30 Spanish-speaking pediatric patients in the US. After the results of the debriefing are analyzed, the Spanish translations are revised as needed in preparation for field testing.

Field Testing of the Neuro-QOL Instrument

Allen Heinemann, PhD, Center for Rehabilitation Outcomes Research,Rehabiliation Institute of Chicago

Following authorization from the Office of Management and Business (OMB) we will begin the second phase of this project (Phase II) in which we will field test item banks and scales. Phase II Field Testing will occur in 2 distinct waves: Wave 1 and Wave 2. Wave 1 will be comprised of a clinical testing sample (Wave 1A) and a general popula-

tion testing sample (Wave 1B). Data will be collected via an online panel, which enables diversification of the sample by disease, geography, gender, economic status and race/ethnicity given the budgetary limitations. The items to be tested will be transferred to the survey layout and subsequently entered into the online administration system. The panel company will then begin using stratified random sampling (to meet diversification requirements) of their 1 million member pre-registered panel.

Wave 1A: Online Clinical Field Testing: The purpose of Wave 1A is to field test the stigma bank and disease targeted scales which would not be appropriate for the Wave IB General Population Testing (see below). Study participants will include several thousand adults diagnosed with Neuro-QOL conditions (Adult and pediatric epilepsy, stroke, ALS, Multiple Sclerosis, Parkinson’s Disease and Muscular Dystro-phy) who were previously identified from a large scale co-morbidity survey conducted by the NIH PRO-MIS study. A minimum of 500 English-speaking adults, 250 Spanish-speaking adults, 100 English and 100 Spanish-speaking children will be recruited for Wave 1A from this panel. See Table 4 for details.

Table 4. Adult and Pediatric Wave 1A Clinical Testing

Adult and Pediatric Banks/Scales Number of items per form

Conditions

Stigma Bank 26 Stroke Epilepsy MS Parkinson’s ALS

Personality & Behavioral Change 20

Sleep Disturbance Scale 20

Weakness/Fatigue Scale 20

Translation Helena Corriea, Translation and Formatting Services , CORE, ENH

Field Testing

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Wave IB: Online General Population Field Testing Approximately 3000 adults (2000 English-speaking and 1000 Spanish speaking) and 1500 children (1000 English-speaking and 500 Spanish-speaking) will be recruited for Wave IB, with each partici-pant taking approximately 80 items. See Table 5 for Wave IB adult/pediatric sampling plans.

Table 5. Adult and Pediatric Wave 1B General Population TestingADULT BANKS Estimated Items Per FormSocial Role Performance 49 Social Role Satisfaction 51Physical Function Screening Item 1Mobility/Ambulation 37Assistive Devices 13Upper Extremity / ADLs 44Depression 31Positive Psychological Function 27Fear/Anxiety 28Cognitive Function 45Applied Cognitive Function 44PEDIATRIC BANKSEmotional Health 46Social Function 38Physical Function Screening Item 1Mobility 39Upper Extremity/ADLs 41Assistive Devices 32

Patient recruitment for Wave II will primarily use in-clinic recruitment. Clinic patients will be enrolled by the site coordinators at collaborating clinics. A letter briefly describing the study will be sent to each patient by his/her doctor. At the next scheduled patient visit, eligibility for Wave II will be confirmed, study proce-dures explained, informed consent obtained, and the appropriate HIPAA documentation completed.

Wave II assessments will consist of 1) a baseline assessment, a test-retest assessment 3-7 days after baseline; and a 180 day follow up assessment; and 2) proxy assessment. Proxy data will be obtained for adult and pediatric patients using n=200 patient/proxy pairs. Eligible proxies must be greater than 18 years old, English speaking, and reside with the adult or child. Proxies will be enrolled (one per patient) consecutively until the goal of 200 proxy-patient pairs has been reached. All proxies will sign an informed consent prior to participation. Approximately half of the baseline sample will participate in the test-retest assessment and half in the six month follow up as-sessment. (Total estimated baseline: N=600 patients + 200 proxies; Test-Retest: N=300 patients + 100 proxies; six month: N=300 patients + 100 proxies).

Wave II: Clinical Testing of Short Forms Following psychometric analysis of Wave I data, short forms will be constructed from the item banks, with content and item location based upon the specific assessment goals and character-istics of the patient population. The number of short forms and the specific focus of each will be determined by the investigators in consultation with the Project Officer and neurology advi-sors. The multiple short forms will be combined into a single instrument (one each for adults and children) with the combined instruments used to assess test-retest reliability, responsiveness to change, and the usefulness of proxy data. One form each for adult and pediatric patients will be tested with English speaking patients and their proxies. Disease specific scales will also be ad-ministered to each appropriate sample. Physician ratings, administration of concurrent measures and/or chart review will be conducted at baseline and as part of the 180-day follow up sample. This wave will enroll approximately 500 adults across five clinical conditions with 100 proxies matched to the Stroke sample, and 100 children across two clinical conditions, with another 100 proxies matched to the pediatric sample.

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Final Instruments

Development of Final Instrument Jin-Shei Lai, PhD, OTR/L, Center on Outcomes, Research and Education, ENH

Data will be analyzed by using Item Response Theory (IRT) model. Items that meet the IRT criteria will be calibrated on the latent trait (e.g., physical function or fatigue). The “final instrument” can take several forms: a full-length instrument, “static” short forms for each scale and “dynamic” computerized adaptive testing (CAT). Multiple short-forms can be produced depending on the purpose of

the short-forms; for example one could construct a short-form for patients with more physical function limitation, a short-form for patients with mild physical function limitation or a short-form that measures patients with various physical function limitations and therefore can be used for epidemiological studies. We also plan to implement the CAT engine to the final item bank which enables individualized tailored testing. Since all items of various forms are calibrated on the same continuum, their scores can be compared in a psychometrically sound manner.

Plans for Availability of Final Instrument Richard Gershon, PhD, Center on Outcomes, Research and Education, ENH

All materials developed under this contract will be made available in the public domain. The final HRQL instrument formatted in Microsoft Word and in PDF format, item banks, and CAT programs will be provided to NINDS, along with associated documentation (comprehensive user manual; imple-mentation, administration, and scoring guidelines; other supporting data and documentation to establish the validity of the measurement system and aid in the interpretation of study results). The Contractor shall be responsible for recommending to NINDS the optimum approach to making the electronic versions of the developed question-naires, item banks, CAT programs and user manual available to the public.

Center on Outcomes, Research and Education (Prime Contractor) Evanston Northwestern Healthcare Research Institute

Rehabilitation Institute of Chicago

Northwestern Medical Faculty Foundation

Children’s Memorial Hospital

Cleveland Clinic Foundation Boston University Westat, Inc. University of Chicago

Dartmouth-Hitchcock Medical Center University of Puerto Rico University of Texas Health Science Center

Other Research Sites

Principal Collaborators

Collaborators in the Northwestern University Community

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1001 University Place

Suite 100

Evanston, IL 60201

Cont’d from Page 1

To accomplish the assigned tasks, we have as-sembled a team of experts in scale construction and validation, advanced (modern and classical) psychometrics, biostatistics, clinical neurology, neurosurgery, physical medicine, linguistics and translation science, multi-center clinical research coordination, and project management. We hope these emerging tools, expected to be released for use in 2009, will be welcomed and applied in your research over the next several years and be-yond. We also hope they will undergo continu-ous scrutiny and improvement an open scientific forum.

www.neuroqol.org

Select Publications Miller, D., Nowinski, C., Victorson, D., Peterman, A., Perez, L. (2005) The Neuro-QOL Project: Establishing Research Priorities through Qualitative Research and Consensus Development. Quality of Life Research, 14 (9), 2031.

Nowinski, C., Victorson, D., Miller, D., Peterman, A., Perez, L., Gonin, R., Frey, W., Xu, J., Moy, C., Cella, D. (2006) Clinician Attitudes toward Quality of Life Measures for Neurological Disorders. Neurology, 66 (Suppl 2), A235.

Cella, D., Victorson, D., Nowinski, C., Peterman, A., Miller & D.M. (2006) The Neuro-QOL project: Using Multiple Methods to Develop a HRQOL Measurement Platform to be used in Clinical Research across Neurological Conditions. Quality of Life Research supplement, A-14, Abstract #1353.

Miller, D., Peterman, A.H., Victorson, D., Nowinski, C., Cella, D. (2007) Evaluating personality and behavior changes following stroke: The devel-opment of a disease targeted Neuro-QOL scale. Quality of Life Research supplement, A-88, Abstract #157/1821.

Perez, L., Huang, J., Jansky, E, Nowinski, C., Victorson, D., Peterman, A., Cella, D. (2007) Using Focus Groups to Inform the Neuro-QOL Mea-surement Tool: Exploring Patient-Centered Health-Related Quality of Life Concepts across Neurological Conditions. Journal of Neuroscience Nursing, 39(6), 342-353.

Lynch, E., Butt, Z., Heinemann, A., Victorson, D., Nowinski, C., & Cella, D. (in press). Stroke-related Quality of Life: Insight from Interviews with Patients and Caregivers. Journal of Rehabilitation.