Genzyme Corporation

We plan to develop a new assessment built on the model of the Pediatric Evaluation of Disability Inventory (PEDI) for infants and children with Pompe disease. The project included the collection of normative data for ages 6 months – 15 years.

A description of the development and validation of the Pompe-PEDI has been published in a recent volume of Pediatric Rehabilitation. A paper describing disability in an international sample of 30 children with Pompe disease was published in Developmental Medicine & Child Neurology., and an adaptive testing approach to the use this assessment has been accepted for publication in Developmental Medicine and Child Neurology. An article on the normative reference curves will appear in Pediatric Neurology. The Pompe-PEDI is currently being used in a major international clinical trial.

Publications

Haley, S.M., Fragala-Pinkham, M.A., Aseltine, R, Ni, P. (2003). Development of a disease-specific disability instrument for Pompe disease. Pediatric Rehabilitation, 6:77-84.

Haley, S.M., Fragala-Pinkham, M.A. , Skrinar, A. (2003). Pompe disease and physical disability. Developmental Medicine & Child Neurology, 45:618-623.

Haley, S.M., Fragala-Pinkham, M.A., Ni, P.S., Skrinar, A.M., Kaye, E.M. (In press). Pediatric physical functioning reference curves. Pediatric Neurology.

Haley, S.M., Fragala-Pinkham, M.A. , Ni, P.S., Skrinar, A.M., Corzo, D. (In press). An adaptive testing approach for assessing physical functioning in children and adolescents. Developmental Medicine and Child Neurology.

Project Name

A Field Trial of a New Outcomes Measurement System

9/02 – 9/04

NIDRR: Project 4 of the RRTC on Measuring Rehabilitation Outcomes

This project, launched during the third year of the Research and Training Center on Measuring Rehabilitation Outcomes, is a longitudinal study of adults with stroke, orthopedic trauma, or medically complex conditions, who are scheduled to be tested 4 times over a 12-month period to measure the responsiveness and sensitivity of our new activity and participation measures compared to FIM and SF-36. Enrollment of 516 subjects, recruited from Massachusetts General Hospital , Spaulding Rehabilitation Hospital , and New England Rehabilitation Hospital , ended in July 2004. Adebola OlanrewajuI, our Project manager, manages the database that automates scheduling and standard reports. The software allows data for automatic sharing of information between this study and its companion study: “Use and Abandonment of Assistive Technology”. During the past year, the Field Core has employed 4 data collectors: Lindsey Maciejewski, BS, ATC; Kathy Acquilano, BA, Maryann McGerigle, BS, OTA, and Julie Brush, BS.

To date, 418 subjects have completed their one-month follow up visit (retention rate = 81%). The retention rate at the six-month follow up visit was 71%. Thus far, 185 completed the study, 43 subjects are deceased and 85 dropped out largely due to poor health or moving out of the area. Thus far, the retention rates are slightly better than predicted. Data collection for this study was completed in July 2004.

Project Name

Genzyme Corporation

The Center for Rehabilitation Effectiveness is working with Genzyme Corporation to develop and field-test a Physical Performance Measure of Functionfor children with a diagnosis of Mucopolysaccharidosis (MPS) Type I.

Fifteen motor performance items were developed based on a comprehensive literature review of similar outcome measures and clinical assessment and interviews of children and youth with MPS I. Results of this work was recently published in Pediatric Rehabilitation. A proposal to norm this standardized instrument is under review.

Publications

Dumas, H.M., Fragala-Pinkham, M.A. , Haley, S.M., Skrinar, A.M., Wraith, J.E., Cox, G.F. (2004). Physical performance testing in Mucopolysaccharidosis I: a pilot study. Pediatric Rehabilitation, 7(4):125-131.

Project Name

Pediatric Brain Injury- Functioning After Brain Injury (FABI) (R44HD365369-02) SBIR Phase II

NCMRR/NICHD/NIH

Wendy J. Coster, Maria A. Fragala-Pinkham, Peng Sheng Ni

Although several instruments have been used to measure functioning in pediatric rehabilitation, most are narrowly focused on basic activities of daily living. None of them are specific to the types of unique problems associated with brain injury. To address this shortcoming, a team of investigators from New England Research Institute (NERI) and Boston University ’s Center for Rehabilitation Effectiveness were awarded a National Institute of Health grant to develop a clinical performance measure for pediatric brain injury, entitled Functioning After Brain Injury (FABI). Clinical performance measures are designed to monitor the outcomes of care associated with the delivery of clinical services.

Project has been completed and score forms and manuals are currently being prepared for dissemination.

Project Name

Computer-adaptive Testing of Post-acute Functioning (R01 HD43568A)

09/01/02 – 08-31/05

NCMRR/NICHD/NIH and AHRQ

Boston University 's Center for Rehabilitation Effectiveness was recently awarded $1,733, 650 from the National Institute of Health (NIH) and the Agency for Healthcare Research Quality (AHRQ) to develop computer adaptive (CAT) software that will more effectively measure outcomes of rehabilitation in post-acute care settings. Dr. John E. Ware, Jr. at QualityMetric, Inc. and Barbara Gandek at the Health Assessment Lab will help develop the functional assessment content and software. Spaulding Rehabilitation Hospital will serve as major clinical site for the evaluation of the CAT products. The series of computer-based measures are expected to be ready for dissemination to the rehabilitation field by 2005.

Field calibration studies will be completed by the end of the summer, 2004, and a prototype CAT will be ready for field trials in the fall.

Publications

Haley, S.M., Coster, W.J., Andres, P.L., Ludlow , L.H., Bond T, Sinclair SJ, Jette, A.M. (2004). Activity outcome measurement for post-acute care. Medical Care, 42: Suppl. 1: I-49 – I-61.

Haley, S.M., Coster, W.J., Andres, P.L., Kosinski, M., Ni, P.S. (2004). Score comparability of short-forms and computerized adaptive testing: an illustration with the Activity Measure for Post-Acute Care (AM-PAC) Archives of Physical Medicine & Rehabilitation, 85; 661-666.

Andres, P.L., Black-Schaffer, R., Ni, P.S., Haley, S.M. (In press). Computer adaptive testing: a strategy for monitoring stroke rehabilitation across settings. Topics in Stroke Rehabilitation.

Project Name

A Field Trial of a New Outcomes Measurement System

9/02 – 9/04

NIDRR: Project 4 of the RRTC on Measuring Rehabilitation Outcomes

This project, launched during the third year of the Research and Training Center on Measuring Rehabilitation Outcomes, is a longitudinal study of adults with stroke, orthopedic trauma, or medically complex conditions, who are scheduled to be tested 4 times over a 12-month period to measure the responsiveness and sensitivity of our new activity and participation measures compared to FIM and SF-36. Enrollment of 516 subjects, recruited from Massachusetts General Hospital , Spaulding Rehabilitation Hospital , and New England Rehabilitation Hospital , ended in July 2004. Adebola OlanrewajuI, our Project manager, manages the database that automates scheduling and standard reports. The software allows data for automatic sharing of information between this study and its companion study: “Use and Abandonment of Assistive Technology”. During the past year, the Field Core has employed 4 data collectors: Lindsey Maciejewski, BS, ATC; Kathy Acquilano, BA, Maryann McGerigle, BS, OTA, and Julie Brush, BS.

To date, 418 subjects have completed their one-month follow up visit (retention rate = 81%). The retention rate at the six-month follow up visit was 71%. Thus far, 185 completed the study, 43 subjects are deceased and 85 dropped out largely due to poor health or moving out of the area. Thus far, the retention rates are slightly better than predicted. Data collection for this study was completed in July 2004.

Project Name

The Use and Abandonment of Assistive Technology

11/02 – 11/05

NIDRR: Project R3 of the Duke AT RRTC

The CRE has a $400,000 sub-contract with Duke University to perform the field- work for a project within their RRTC on Advancing Assistive Technology Outcomes. Eligible subjects participating in the RRTC Project 4 are recruited to also participate this study. The AT study involves 4 subject interviews over a 2 year period regarding use and abandonment of AT devices. This study utilizes activity and participation data from Project 4. Data collectors hired by the CRE are working on both Project 4 and the AT project. Subject recruitment began in August of 2002.

In February 2003, we added Braintree Rehabilitation Hospital as a recruitment site to improve the rate of enrollment. As of October 2003, new recruitment was limited to subjects who obtained a new wheelchair per study P.I. All recruitment ended April 2004. A total of 216 subjects were enrolled, 165 completed the 6-month follow up visit, 65 completed the 12-month follow up visit. Twelve subjects have died since they enrolled in this study, and nine subjects have dropped out due to failing health.

Project Name

Consumer Assessment of Health Plans Survey (CAHPS II) for Persons with Mobility Impairments

06/01/02 – 06/30/04

Agency for Health Care Policy and Research

Paul Cleary (Harvard School of Public Health), Stephen M. Haley (BU site PI)

The Consumer Assessment of Health Plans Study, or CAHPS II, has been funded by the to develop surveys and reports that make it possible to compare consumer’s satisfaction with different health plans and providers. Supplemental CAHPS surveys exist to explore the satisfaction of consumers who have particular health care problems or needs. People with mobility impairments (PWMI) have different health care needs from the general population. Therefore, the aim of the CAHPS –PWMI project is to develop a supplemental CAHPS survey to allow consumer assessments of health care for persons with mobility impairments.

The focus of the CAHPS-PWMI project in 2003-4 was on developing, evaluating and field testing screening questions to identify PWMI. Draft screening questions were developed. These questions were evaluated in cognitive testing of 14 participants who had mobility impairments at two sites. These questions were modified based on the results of the cognitive testing, and have been included in a large survey of Medicaid recipients in Massachusetts . These data will be analyzed in July 2004. Further development of the content of the survey will take place in 2004-05.

Project Name

Strong for Life / Faith in Action Pilot Dissemination Project

09/15/02 – 10/31/04

Robert Wood Johnson Foundation

Alan M. Jette

The aim of this project was to determine whether a home-based exercise program for older adults (Strong for Life) could be successfully disseminated to home-bound older people using volunteers from a national organization (Faith in Action). The program was disseminated to 10 Faith in Action sites in diverse regions around the country. Physical therapy trainers visited each site and trained volunteers, who were matched one-on-one with an exercise participant. The volunteer trainers taught the program to the the older exercise participants, and visited them weekly for one year.

A total of 105 participants were recruited into this project. The exercise participants, volunteers and site co-ordinators reported high levels of satisfaction with the program. The final outcome evaluations are now complete and are being analyzed and the main article from this work should be submitted for publication by September 2004.

Project Name

Ortho Trauma Assessment Instrument Generated Using Item Response Theory

1/1/03 – 12/31/03

Orthopedic Trauma Association

Mark Vrahas, MGH Orthopedics, Stephen Haley (BU Site P.I)

This study was a collaborative effort between the CRE and Partners Orthopaedic Trauma Services. The purpose of this project was to develop a sensitive, comprehensive, and feasible orthopedic trauma outcome assessment instrument. The CRE was responsible for the study design and data collection strategies as well as data entry and data analysis for this project. The product of this project is a short fixed-length orthopedic trauma assessment (SOTA) instrument that provides both improved efficiency and breadth compared to the short MFA.

A heterogeneous sample of 161 adults, at least 3 months status post injury to one or more extremities, completed a questionnaire consisting of all items within the item pool that includes all the items from the short MFA. Data were analyzed using factor analysis and Item Response Theory (IRT) to determine the scoring properties of the entire item pool as well as of the short MFA. From these analyses we determined the item pool's most useful items and created a short form that consists three domains (lower extremity, upper extremity, and role/emotional).

Project Name

A Standardized Classification System for PT and OT Interventions / RRTC Project 3

01/01/04 – 12/31/04

Boston University Aging Research Center / NIDDR

Susan Horn, Institute for Clinical Outcomes Research, Nancy Latham (BU Site PI)

Our center has been working with Susan Horn from the Institute for Clinical Outcomes Research to expand the work that began in RRTC Project 3 to understand the interventions used during inpatient rehabilitation and develop a classification system, or taxonomy, for PT and OT interventions. The aim of the BUARC pilot project is to develop a prototype of a comprehensive standardized classification system for physical and occupational therapy interventions used in geriatric rehabilitation.

We are analyzing the data from the Stroke Outcomes Study to increase our understanding the initial classification system by exploring how frequently therapists use the activities and interventions included in this system, the validity of the structure that was used and the underlying constructs of this system. In the second half of 2004 we will use the results of these analyses and input from expert physical and occupational therapists to develop a prototype classification system.

Jette, D.U., Latham, N.K., Smout, R.J., Gassaway, J., Slavin, M.D., Horn, S.D. (In press). Physical therapy interventions for patients with stroke in in-patient rehabilitation facilities. Physical Therapy.

Project Name

Community Fitness Programs for Children with Disabilities

09/2003 – 09/2004

Noonan Foundation and the Giving Tree Foundation

Maria A. Fragala- Pinkham

The Research Center at Franciscan Hospital for Children received a $78, 000 grant from the Noonan Foundation and a $5000 from the Giving Tree Foundation to carry out this project.This project was designed for thirty children with disabilities to participate in a model group fitness program in a community setting. The program was designed to improve fitness including strength, cardiorespiratory endurance, flexibility, and functional skills. Community fitness trainers from three YMCA’s ( Brighton , Waltham and Beverly) help coordinate and lead the classes. Consultation about the fitness activities, exercise intensity, and exercise modifications is provided by pediatric physical therapists. PT and OT students from Boston University Sargent College are assisting children during the fitness classes. The two times per week fitness classes will run for 16 weeks from March until the end of June. The effectiveness of the fitness program will be measured in a pretest-posttest group design.

The fitness of the participants was measured in June/July. Stephen Haley will be assisting with the data analysis and dissemination of the project.

Project Name

Developing a Computer Adaptive TBI Cognitive Measure.

4/1/04 – 3/31/04

NIH/NICHD R21 HD045869-01

Craig Velozo, ( University of Florida )

This primary aim of this planning project is to create the foundation for a computer adaptive cognitive measure for persons with TBI. Initial work will be directed toward creating a cognitive item bank that represent observable indicators of cognitive function for persons with TBI across the continuum of recovery. The project will test the feasibility of using computer adaptive approach with this population and will design a multi-center trial to test reliability, validity, and sensitivity of the new measure.

The initial set of applied cognitive items developed in RRTC Project 1, and refined for use in the R01 PAC-CAT project were shared with the primary investigators, along with results of initial Rasch analyses. The investigators have outlined a conceptual structure to identify key areas of cognition that need to be considered for assessment. This framework will guide an extensive literature review now underway to retrieve additional items that may extend the range and scope of the initial item set. The literature review is expected to be complete in early Fall. Agreements with facilities in Florida who will participate in item generation, review, and testing are being formalized.

Coster, W.J., Haley, S.M., Ludlow , L.H., Andres, P.L., Ni, P.S. (In press). Development of an applied cognition scale for rehabilitation outcomes measurement. Archives of Physical Medicine and Rehabilitation.

Project Name

The Patterns of Functional Change Over Time during Hip Fracture Rehabilitation

06/03 – 06/04

Dudley Allen Sargent Research Fund

Nancy Latham

Peng Sheng Ni, Reg Warren (SeniorMetrics), Diane Jette ( Simmons College )

Hip fracture is a common and serious health problem for older people, but the functional changes that take place during hip fracture rehabilitation continue to be poorly understood. This project is using a retrospective cohort design to explore the pattern of changes in functional status that occur during hip fracture rehabilitation in skilled nursing facilities. This project is a collaboration between our center and SeniorMetrix Inc.

We have completed data entry and data cleaning for all cases. Our dataset includes 832 people who were admitted to a skilled nursing facility for rehabilitation following a hip fracture in 2002. The mean age of the hip fracture patients is 82 years, and they received an average of 10 physical therapy visits. Further analyses to explore the pattern of functional change during each week of therapy are being conducted using descriptive, graphical and regression analyses.

Project Name

How Access Affects Outcomes of Rehabilitation Services

2/04 – 2/06

NCMRR/NICHD/NIH RO1

Lisa Iezzoni, (BU on-site P.I.: Alan M. Jette)

Karen Jacobs, Pat Andres

The specific aim of the proposed study is to examine the association between the intensity of PT and OT services and likelihood of good outcomes, including lower rates of: self-reported functional decline; worsening overall health; activities of daily living (ADL) and instrumental ADL (IADL) dependence; institutionalization; acute care hospitalization; injury prompting medical attention; decubitus ulcer development; purchase of assistive technology (AT); social isolation; and death. To test our hypotheses about the relationships between PT and OT intensity and outcomes of care, we shall examine experiences before and after the BBA, using the 1994-2001 Medicare Current Beneficiary Surveys (MCBS) linked with Medicare claims.

The primary outcome of the proposed study will be an assessment of the associations of PT and OT, as routinely practiced in communities nationwide, with important outcomes of care. Although our database does not contain a direct measure of patients' quality of life, our outcome indicators (e.g., institutionalization, declining functional abilities, social isolation) are closely linked to quality of life. Our study could suggest how financial access to rehabilitation services affects the functional outcomes of an important subpopulation of Americans, Medicare beneficiaries with potentially debilitating conditions.

The BU group conducted a comprehensive review of literature on changes in rehabilitation in home care and skilled nursing facilities since PPS was initiated. The BU group held a focus group in June 2004 of clinical experts in the field of home care rehabilitation to access their opinions regarding the effects of PPS.