Development of the International Spinal Cord Injury Basic Data Set for informal caregivers.

STUDY DESIGN: Mixed-methods, including expert consensus for initial development and a multi-center repeated measures design for field testing. OBJECTIVES: To develop an International Spinal Cord Injury Basic Data Set for caregivers of individuals with spinal cord injury/disorder (SCI/D) for use in research and clinical care settings. SETTING: International, multi-disciplinary working group with field testing in five North American pediatric rehabilitation hospitals. METHODS: The data set was developed iteratively through meetings and online surveys with a working group of experts in pediatric and adult SCI/D rehabilitation and caregivers of individuals with SCI/D. Initial reliability was examined through repeat administration of a beta form with a sample of caregivers recruited by convenience. The sample was characterized with descriptive statistics. Intra-rater reliability of variables was assessed using Intra-Class Correlations. RESULTS: The beta test form included 27 items, covering 3 domains: (1) demographic information for persons providing care; (2) caregiver's allocation of time and satisfaction; and (3) perceived burden of caregiving. Thirty-nine caregivers completed both administrations. Mean time for completion was 10 min. There was moderate to excellent reliability for the majority of variables, but results indicated necessary revisions to improve reliability and decrease respondent burden. The final version of the data form contains 7 items and is intended for self-administration among informal caregivers of individuals with SCI/D across the lifespan. CONCLUSIONS: The International SCI Basic Data Set for Informal Caregivers can be used to standardize data collection and reporting about informal caregivers for individuals with SCI/D to advance our understanding of this population and the data form has additional utility to screen for caregiver needs in clinical settings.

Evaluation of the International Spinal Cord Injury Bowel Function Basic Data Set Version 2.0 in Children and Youth With Spinal Cord Injury.

OBJECTIVES: To establish the utility and feasibility of the International Spinal Cord Injury/Dysfunction (SCI/D) Bowel Function Basic Data Set Version 2.0 in pediatric SCI populations. METHODS: This was a noninterventional, repeated measure design conducted in Pennsylvania, Maryland, Illinois, Kentucky, and South Carolina. The International Spinal Cord Injury/Dysfunction (SCI/D) Bowel Function Basic Data Set Version 2.0 was administered repeatedly, twice at the point of care and once over the phone. Time to complete the data set was recorded. Inter- and intrarater reliability was examined by intraclass correlation coefficients (ICC) with 95% confidence intervals (CI), and agreement between the bowel function basic data set variables and medical records was calculated using percentages. Intrarater reliability involved the same person administering the data once at the point of care and once over the phone. RESULTS: Forty-one children/youth ages 1 to 20 years participated in this study. Average time to complete the data set was 5.17 minutes. Interrater reliability was good to excellent (ICC ≥ 0.75) for most variables. Five variables had moderate interrater reliability (ICC = 0.05-0.74) and three had poor interrater reliability (ICC < 0.05). With the exception of one variable that had poor intrarater reliability (constipating agent, ICC = 0.00) and one that approached moderate reliability (digital evacuation, ICC = 0.74), intrarater reliability was good to strong for every bowel variable (ICC = 0.88-1.00). Only 12 (32%) medical records had explicit documentation of one or more of the variables on the Basic Bowel Function Basic Data Set V2.0. CONCLUSION: The results support future research with a larger and more diverse sample of children with SCI to build upon the psychometric work described herein.

Conversion Furlow Palatoplasty and the Use of Preoperative Video Nasendoscopy.

OBJECTIVE: To assess outcomes after conversion Furlow palatoplasty with and without routine preoperative flexible fiberoptic video nasendoscopy (FFVN). DESIGN: Retrospective cohort study. SETTING: Tertiary Children's Hospital. PATIENTS: Greater than 3 years of age with cleft palate and velopharyngeal insufficiency (VPI) after straight-line palatoplasty requiring secondary surgery performed with a Furlow palatoplasty. MAIN OUTCOME MEASURES: The number of children with and without routine FFVN prior to conversion Furlow palatoplasty for VPI after initial straight-line palatoplasty. Groups were compared for surgical timing, speech outcomes, and need for additional surgery after conversion Furlow palatoplasty. RESULTS: Fifty-eight patients underwent preoperative FFVN versus 29 without. Mean age at FFVN was 73.8 (SD 34) months. Mean age for secondary palatal surgery by conversion Furlow palatoplasty was 81.5 (SD 34.8) months with FFVN versus 73.4 (SD 34.0) months without FFVN. There was a significant difference (P < .001) for VPI diagnosis and time to surgery between the groups. Preoperative hypernasality ratings were similar between groups. Postoperatively 65.5% of FFVN and non-FFVN patients corrected to normal resonance. Only 6.9% of all patients rated moderate-severe hypernasality after surgery compared to 42.5% preoperatively. Of total, 5.7% of patients had unchanged hypernasality and only 1 patient rated worse. Seven patients ultimately required additional surgery in attempt to normalize their resonance. CONCLUSIONS: Routine preoperative FFVN does not offer any advantage for improved outcomes in children undergoing conversion Furlow palatoplasty after straight-line repair. Routine preoperative FFVN was associated with increased time to surgery after diagnosis of VPI compared to those without FFVN.

Development of the International Spinal Cord Injury/Dysfunction Education Basic Data Set.

Study design: Consensus among international experts. Objectives: The objective of this project was to develop the International Spinal Cord Injury/Dysfunction (SCI/D) Education Basic Data Set. Setting: International expert working group. Methods: The published guidelines for developing the International SCI Basic Data Sets were used to develop the International SCI/D Education Basic Data Set. Existing measures and literature on education and disability were reviewed to develop a preliminary draft of the basic education data set through iterative modifications via biweekly conference calls and email communication. The draft was disseminated to the larger International Workgroup for Development of Pediatric SCI/D Basic Data Sets and then to the members of the International Spinal Cord Society (ISCoS), American Spinal Injury Association (ASIA), and relevant expert groups and interested individuals for comments. All feedback received was taken into consideration before the final data set was approved by ISCoS and ASIA. Results: The finalized version of the International SCI/D Education Basic Data Set Version 1.0 contains 16 items divided into three domains: school setting/therapeutic services, school participation/academic success, and barriers/attitudes. Most of the variables have been adapted from established measures. This data set is intended for children and youth up to and including high school, but not for emerging adults in higher education or postsecondary vocational training or trade schools. Conclusion: The International SCI/D Education Basic Data Set has been developed for collection of a minimal amount of highly relevant information on the education experience in children and youth with SCI/D. Further validation work is needed. Sponsorship: This project was funded by the Rick Hansen Institute, Research Award #G2015-27 (Mulcahey, PI).

The International Spinal Cord Injury Pediatric Activity and Participation Basic Data Set.

Study design: International focus groups. Objectives: The objective of this project was to develop the International Spinal Cord Injury (SCI) Pediatric Activity and Participation (A&P) Basic Data Set. Methods: A focus group of experts in pediatric and adult SCI, and contributors of the existing adult International SCI Adult A&P Basic Data Set convened to develop an initial draft of the data set, which was iteratively refined over a 12 month period based on relevant literature and existing outcome measures that evaluate pediatric activity and participation. The draft was reviewed and approved by the larger project working group and then distributed to the International Spinal Cord Society (ISCoS), American Spinal Injury Association (ASIA), and relevant expert groups for review. Feedback received was considered before the final data set was approved. Results: The International SCI Pediatric A&P Basic Data Set is comprised of 13 variables: administration date, mobility, dressing, feeding, toileting, communication, family outings, spending time with friends, being out with friends, participating in team or club activity, paid work, dating, and physical activity. It is intended for children between 6 and 17 years of age, who have been discharged from initial rehabilitation/hospitalization for a minimum of 3 months. Conclusion: The International SCI Pediatric A&P Basic Data Set was developed to standardize the recording of a minimal amount of information about activities and participation in children with SCI. Further work on reliability and cultural validation is needed. Sponsorship: This study was funded by the Rick Hansen Institute, Research Award #G2015-27 (Mulcahey, PI).

Evaluation of the Capabilities of Upper Extremity Test (CUE-T) in Children With Tetraplegia.

Background: The Capabilities of Upper Extremity Test (CUE-T) is a spinal cord injury (SCI)-specific instrument based on the CUE Questionnaire (CUE-Q). Objective: To evaluate the psychometric properties of CUE-T in children with cervical SCI and determine the lowest age appropriate for test administration. Method: In this repeated measures multicenter study, 39 youths, mean age 12.3 years and mean time post injury 5.14 years, completed two administrations of the CUE-T. Test-retest reliability, internal consistency, and known groups validity were measured. Concurrent and discriminant validity were measured against previously validated measures: CUE-Q, Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP), Spinal Cord Independence Measure (SCIM) III, SCIM III-Self Care (SCIM-SC), and SCIM-Mobility. Results: The CUE-T scores demonstrated strong test-retest reliability (ICC ≥ 0.95), strong internal consistency (α ≥ 0.90), and acceptable individual item agreement (κ ≥ 0.49). The hand subscale had better scores (p < .05) for the motor incomplete versus complete known groups, and the arm, hand, and side subscales had better scores (p < .05) for higher versus lower strength groups. The CUE-T had strong concurrent validity with the CUE-Q (r = 0.85-0.87), GRASSP (r = 0.78-0.90), and SCIM-SC (r = 0.70) and moderate-to-weak correlation with the total SCIM (r = 0.65) and SCIM-Mobility (r = 0.51). Children older than 6 years with mature grasp patterns were able to complete the CUE-T. Conclusion: The CUE-T scores are reliable and valid for use in children with cervical SCI older than 6 years of age.

Evaluation of the graded redefined assessment of strength, sensibility and prehension (GRASSP) in children with tetraplegia.

STUDY DESIGN: Psychometric study. OBJECTIVE: To validate the GRASSP in pediatric SCI populations and establish the lower age of test administration. SETTING: United States: Pennsylvania, Maryland, Illinois, Michigan, California, Texas. METHODS: Mean, SD and range of scores were calculated and examined for known-group differences. Test-retest reliability was measured by the intra-class correlation, concurrent validity of the GRASSP against the SCIM, SCIM-SS, and the CUE-Q was measured by the Spearman correlation. RESULTS: GRASSP scores differed between participants with motor complete and incomplete injuries (p = <0.0001-0.036). Test-retest reliability was strong (ICC = 0.99). Weak correlation with the total SCIM (r = 0.33-0.66), and moderate to strong correlation with the SCIM-SC (r = 37-0.70) and CUE-Q (r = 0.40-0.84). CONCLUSION: Results support the validity of the GRASSP and provide evidence that the scores are reliable when administered to children. The GRASSP sensory and strength subtests are recommended for children beginning at 6 years of age, and the GRASSP prehension performance/ability subtest for children beginning at 8 years of age. Normative data are needed for the performance components of the GRASSP.