Progress Repor t 2004 - 2007

952 views
873 views

Published on

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
952
On SlideShare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
3
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Progress Repor t 2004 - 2007

  1. 1. Neuro-QOL Pr o g r e s s Rep or t 2004 - 2007 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
  2. 2. Message from the Principal Investigator Quality of Life Outcomes in Neurological Disorders David Cella, PhD, The aim of this study is to devel- Center on Outcomes, Research and Education, ENH N euro-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 op a core set of adults and children with common neurological disorders. These tools are intended to be responsive questions that will to the needs of clinical researchers and facilitate comparison of results across clinical trials in dif- address dimen- ferent diseases. To accomplish this, we proposed to develop, modify, and test item banks, or finite sions of Health- sets of questions, that are designed to assess common concepts that cut across virtually all selected Related Quality of diseases. We further proposed to add to these generic item banks separate sets of unique, targeted Life (HRQL) that scales to evaluate symptoms, concerns or issues that are relevant only to a subset of diseases or treat- are universal to ments. The primary end users of this measurement system will be clinical trialists and other clinical patients with neurology researchers; however the item banks should also be appropriate for clinical practice. chronic neurologi- cal diseases. 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 We will also devel- as “generic” and “disease specific,” are typically used to designate the distinction between HRQL op supplemental concepts that are common versus unique across conditions, respectively. This distinction has been questions or mod- manifest in two types of static questionnaires: Generic ones that are administered to all patients ules that address across conditions, and disease-specific (or targeted) ones that are administered only to patients with additional HRQL a given condition. The former set tends to emphasize self-reported function and well-being; the lat- concerns that are ter set tends to emphasize disease symptoms. This is inefficient and suboptimal for communication specific to par- and interpretation of results from clinical research. It is inefficient because: a) it results in instru- ticular groups of ment-based requirements to ask more questions than are relevant in a given research setting; and b) patients defined it ties one to the same set of questions to measure a given concept, even though a different set might by disease, age, or be preferred in one disease versus another. It is suboptimal because it discourages the user from other factors. 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) 2
  3. 3. Message from the Project Officer Patient-Reported Outcomes Advancing the State of PROs in Neurology - an NINDS Initiative Claudia Moy, PhD, NINDS T he 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. The mission of the National These measures are essential in order to provide the full Institute of Neurological Disorders picture of the effect of intervention on patients. and Stroke (NINDS) is to reduce the Some aspects of health-related quality of life have been burden of neurological disease - incorporated into many recent or current clinical trials a burden borne by every age in neurology, usually as secondary outcome measures. group, by every segment of soci- Many measurement scales have been developed for use ety, by people all over the world. 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. 3
  4. 4. Accomplishments and Milestones S ince 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: Criteria for Acceptance • 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. 4
  5. 5. 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 Literature Reviews 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: Major Neurological Conditions Identified in the Literature Review 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 5
  6. 6. 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) Patient & Expert Input 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
  7. 7. Final Recommendations Framework of Item Bank/Scales After consideration of expert and consensus meeting findings, as well as discussions with members to be Developed of the NINDS, the Neuro-QOL Executive Committee finalized this list of adult and pediatric and Tested 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- PHYSICAL trophies. Function/ Health Table 3. Final Recommendations Adult Conditions • Mobility/Ambula- Stroke tion • Self-Care / Multiple Sclerosis Upper Extremity Parkinson’s disease Epilepsy Symptoms Neuromuscular Disorders (Amyotrophic Lateral Sclerosis and Myasthenia Gravis) • Sleep Disturbance Pediatric Conditions • Fatigue Epilepsy • Pain Muscular dystrophies • Personality/ Behavior Change Selection of Domains and Sub- MENTAL Domains Emotional Health and their treatments. Finally, we con- David Victorson PhD, Center on Outcomes, Research and Education, ENH ducted 11 focus groups with patients • Anxiety/Fear and caregivers (seven with patients • Depression We identified domains through mul- (n=64); four with caregivers (n=19)) • Stigma tiple methods and data sources. Initially, to assess the impact of neurological • Positive Psychologi- we identified domains through completing an extensive conditions on health related quality of cal Function literature review of 24 neurological conditions from life (HRQL) domains. We began with 1996 to the present (previously described). From this broad questions, allowing participants to Cognitive Health review, our initial list of domains included: emotional free-list responses on their definition of distress, perceived cognitive functioning, social func- HRQL. We then progressed to ques- • Perceived Deficits tioning, physical functioning, fatigue, pain, communica- tions regarding specific HRQL domains, • Applied Cognition tion/language difficulty, positive psychological func- such as physical functioning, emotional tioning, sexual functioning, bowel/bladder function, functioning, social aspects, and treat- SOCIAL sleep disturbance and personality/behavioral changes. ment effects that have been shown to be Using each domain and Neuro-QOL disease as search relevant in the literature. Focus groups Role Performance terms, we identified the number of published studies in with caregivers of Alzheimer’s Disease, a given area to provide an estimate of how important stroke, and pediatric epilepsy patients Role Satisfaction certain domains were within different neurological were conducted as these patients may be conditions. unable to reliably report their subjective We also conducted two separate waves of ex- perceptions of HRQL due to cognitive pert interviews (n=44 and n=63) and an online expert impairment or age. The following con- request for information (n=89) to identify important ceptual domain framework is the synthe- domains that are affected by neurological disorders sis of these data sources: See side bar 7
  8. 8. Conducted Examined literature external, large review to datasets with identify items items and reflecting instruments Item Identification and Selection Process Neuro-QOL reflecting content Neuro-QOL conditions & domains Items set in standardized format with preliminary domain assignments were entered into the Neuro-QOL Item Library Selection of Items selected from winnowing underwent Items sent to content Development Items a more thorough review done collaboratively experts in Neuro-QOL Deborah Miller, PhD, Depart- by two domain co-chairs and several outside domains to review (Ex- ment of Neurology, The Cleve- pert Item Review) content experts. Most items needed revision land Clinic for general consistency across banks. Re- Instruments and items were identified by Neu- writing or generating new items was done to Domain content experts ro-QOL investigators and expert consultants by assure comprehensiveness in measuring the sorted items into sub- domain; clear, understandable and precise domains (binning), and literature searches and previous item banking then reviewed items to projects, which were delivered to a centralized language to experts and respondents; ame- select those that would Neuro-QOL Item Library. Over 3,000 items nable to linguistic translation; and adapted undergo qualitative item review (winnowing) were entered into the Neuro-QOL Item Library to the data collection and analysis strategies according their elements such as item order, planned. Findings from individual cognitive context, time frame, item stem and response interviews and dataset analyses were provid- Patient input ed to content groups to integrate into deci- received on Criteria were set. Once the Neuro-QOL item library was comprehen- established to populated, items were assigned to the Neuro- sion making. During this process, PROMIS sibility and evaluate and QOL domains through an iterative, multi-step and Activity Measure for Prostate Acute relevance of rewrite items all domains & process involving at least three domain experts. Care (AM-PAC) items were compared with item content Two independent raters worked collaboratively Neuro-QOL items and redundancy was areas via eliminated. Final item pools were reviewed individual to bin items to primary domains followed by cognitive Neuro-QOL agreement and reconciliation by a 3rd reviewer by patients with the Neuro-QOL conditions interviews domain teams (n=63) during telephone-based cognitive trained on to ensure consistency across domains. As the Results from item review number of items (many redundant) that existed interviews in English and Spanish to assess cognitive process the content validity of items, clarify concepts, in the library was large, all items were reviewed interviews & refine language and response options. Dur- dataset analy- to determine if they should proceed through ses returned detailed item review/revision/testing and were ing interviews patients reviewed each item Content & to domain translation grouped together according to each domain’s in a one-on-one semi-structured interview groups focused on item comprehension and rel- experts and hierarchy of sub-domains, factors, and facets. domain evance. Patients and experts also identified PROMIS teams review, and BU items rewrite, and Content experts then systematically removed areas (gaps in domain) for new item devel- compared evaluate each (“winnowed” )items from item pools. The fol- opment and creation, to which new items and recon- item (Expert ciled with Item Review) lowing exclusion criteria were used: semantic were written or revised. See Figure 2 for an Neuro-QOL redundancy, availability of a superior alternative, overview of the item identification and selec- domains & inconsistency with domain definition, wrong do- tion process. items; new items added, Results used main assignment, vague or confusing language, redundant to draft new cultural/translation relevance, gender inappro- eliminated items and priate, too narrow or too disease specific. further revise existing items Final item pool devel- Experts oped: Items review of new ready for items testing 8
  9. 9. In- Translation sert Helena Corriea, Translation and Formatting Services , CORE, ENH 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 Field Testing 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 Conditions items per form Stigma Bank 26 Stroke Personality & Behavioral Change 20 Epilepsy Sleep Disturbance Scale 20 MS Weakness/Fatigue Scale 20 Parkinson’s ALS 9
  10. 10. 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 Testing ADULT BANKS Estimated Items Per Form Social Role Performance 49 Social Role Satisfaction 51 Physical Function Screening Item 1 Mobility/Ambulation 37 Assistive Devices 13 Upper Extremity / ADLs 44 Depression 31 Field Testing Positive Psychological Function 27 Fear/Anxiety 28 Cognitive Function 45 Applied Cognitive Function 44 PEDIATRIC BANKS Emotional Health 46 Social Function 38 Physical Function Screening Item 1 Mobility 39 Upper Extremity/ADLs 41 Assistive Devices 32 Wave II: Clinical Testing of Short Forms Following psychometric analysis of Wave I data, Patient recruitment for Wave II will primarily use in- short forms will be constructed from the item clinic recruitment. Clinic patients will be enrolled by banks, with content and item location based the site coordinators at collaborating clinics. A letter upon the specific assessment goals and character- briefly describing the study will be sent to each patient istics of the patient population. The number of by his/her doctor. At the next scheduled patient visit, short forms and the specific focus of each will be eligibility for Wave II will be confirmed, study proce- determined by the investigators in consultation dures explained, informed consent obtained, and the with the Project Officer and neurology advi- appropriate HIPAA documentation completed. sors. The multiple short forms will be combined Wave II assessments will consist of 1) a baseline into a single instrument (one each for adults and assessment, a test-retest assessment 3-7 days after children) with the combined instruments used baseline; and a 180 day follow up assessment; and 2) to assess test-retest reliability, responsiveness to proxy assessment. Proxy data will be obtained for change, and the usefulness of proxy data. One adult and pediatric patients using n=200 patient/ form each for adult and pediatric patients will be proxy pairs. Eligible proxies must be greater than 18 tested with English speaking patients and their years old, English speaking, and reside with the adult proxies. Disease specific scales will also be ad- or child. Proxies will be enrolled (one per patient) ministered to each appropriate sample. Physician consecutively until the goal of 200 proxy-patient pairs ratings, administration of concurrent measures has been reached. All proxies will sign an informed and/or chart review will be conducted at baseline consent prior to participation. Approximately half of and as part of the 180-day follow up sample. This the baseline sample will participate in the test-retest wave will enroll approximately 500 adults across assessment and half in the six month follow up as- five clinical conditions with 100 proxies matched sessment. (Total estimated baseline: N=600 patients to the Stroke sample, and 100 children across + 200 proxies; Test-Retest: N=300 patients + 100 two clinical conditions, with another 100 proxies proxies; six month: N=300 patients + 100 proxies). matched to the pediatric sample. 10
  11. 11. 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- Final Instruments 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. Collaborators in the Northwestern University Community 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 Principal Collaborators Cleveland Clinic Foundation Boston University Westat, Inc. University of Chicago Other Research Sites Dartmouth-Hitchcock Medical Center University of Puerto Rico University of Texas Health Science Center 11
  12. 12. Select Publications Cont’d from Page 1 Miller, D., Nowinski, C., Victorson, D., Peterman, A., Perez, L. (2005) The Neuro-QOL Project: Establishing Research Priorities through Qualitative To accomplish the assigned tasks, we have as- Research and Consensus Development. Quality of Life Research, 14 (9), sembled a team of experts in scale construction 2031. and validation, advanced (modern and classical) psychometrics, biostatistics, clinical neurology, Nowinski, C., Victorson, D., Miller, D., Peterman, A., Perez, L., Gonin, neurosurgery, physical medicine, linguistics and R., Frey, W., Xu, J., Moy, C., Cella, D. (2006) Clinician Attitudes toward translation science, multi-center clinical research Quality of Life Measures for Neurological Disorders. Neurology, 66 (Suppl coordination, and project management. We hope 2), A235. these emerging tools, expected to be released for use in 2009, will be welcomed and applied in Cella, D., Victorson, D., Nowinski, C., Peterman, A., Miller & D.M. (2006) your research over the next several years and be- The Neuro-QOL project: Using Multiple Methods to Develop a HRQOL yond. We also hope they will undergo continu- Measurement Platform to be used in Clinical Research across Neurological ous scrutiny and improvement an open scientific Conditions. Quality of Life Research supplement, A-14, forum. 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. 1001 University Place Suite 100 Evanston, IL 60201 www.neuroqol.org

×