ABSTRACT
OBJECTIVE: The objective of this study was to determine the reliability of measuring wound undermining in people with spinal cord injury (SCI). STUDY DESIGN: A psychometric study. SETTING: The study was conducted at the Indian Spinal Injuries Centre, New Delhi, India. PARTICIPANTS: Thirty people with a complete or incomplete SCI and a pressure ulcer with wound undermining were recruited. METHODS: Wound undermining was measured using the four cardinal points from a clock face (with 12 O'clock defined as towards the head). Inter-rater reliability was tested by comparing the wound undermining scores from two different assessors. Intra-rater reliability was tested by comparing the wound undermining scores from the same assessor on two different days. RESULTS: The intraclass correlation coefficients (95% confidence interval) for inter-rater and intra-rater reliability were 0.996 (0.992-0.999) and 0.998 (0.996-0.999), respectively. Repeat measurements by the same and different assessor were within 0.3 cm of each other, 80% and 83% of the time, respectively. CONCLUSION: Measurements of wound undermining have excellent reliability.
Subject(s)
Physical Examination/methods , Pressure Ulcer/diagnosis , Pressure Ulcer/etiology , Spinal Cord Injuries/complications , Spinal Cord Injuries/diagnosis , Adult , Female , Humans , Male , Pressure Ulcer/physiopathology , Psychometrics , Reproducibility of Results , Spinal Cord Injuries/physiopathology , Young AdultABSTRACT
STUDY DESIGN: Psychometric study. OBJECTIVES: To determine the intra- and inter-rater reliability and content validity of the International Spinal Cord Injury (SCI) Musculoskeletal Basic Data Set (ISCIMSBDS). SETTING: Four centers with one in each of the countries in Australia, England, India and the United States of America. METHODS: A total of 117 participants with a C2 to S1 neurological level and American Spinal Injury Association Impairment Scale A to D injury were recruited. The median (interquartile range) time since injury was 9 years (2-29). Fifty-seven participants were assessed by the same assessor, and 60 participants were assessed by two different assessors on two different occasions to determine the intra- and inter-rater reliability, respectively. Kappa statistics or crude agreement was used to measure reliability. Content validity was assessed through focus group interviews of people with SCI and health-care professionals. RESULTS: The intra-rater reliability ranged from κ=0.62 to 1.00 and crude agreement from 75% to 100% for each of the variables on the ISCIMSBDS. The inter-rater reliability ranged from κ=-0.25 to 1.00, with a diverse crude agreement ranging from 0% to 100%. The inter-rater reliability was unsatisfactory for the following variables: 'Date of fracture', 'Fragility fractures', 'Scoliosis, method of assessment', 'Other musculoskeletal problems' and 'Do any of the above musculoskeletal challenges interfere with your activities of daily living (transfers, walking, dressing, showers, etc.)?'. Results from validity discussions implied no major suggestions for changes. CONCLUSION: Overall, the ISCIMSBDS is reliable and valid, although 5 of the 12 variables may benefit from further refinement.
Subject(s)
Bone Diseases/complications , Datasets as Topic/standards , Muscular Diseases/complications , Spinal Cord Injuries/complications , Adult , Antisocial Personality Disorder , Australia , Bone Diseases/physiopathology , Bone Diseases/therapy , England , Female , Fractures, Bone/complications , Fractures, Bone/physiopathology , Fractures, Bone/therapy , Humans , India , Male , Middle Aged , Muscular Diseases/physiopathology , Muscular Diseases/therapy , Reproducibility of Results , Severity of Illness Index , Spinal Cord Injuries/physiopathology , Spinal Cord Injuries/therapy , Time Factors , United StatesABSTRACT
STUDY DESIGN: Phase- I/II, prospective, randomized, single-blind, controlled pilot study. PRIMARY OBJECTIVE: To determine the safety and feasibility of autologous bone marrow transplantation in patients with acute spinal cord injury (SCI) via two routes of transplantation as compared with controls. SETTING: Indian Spinal Injuries Center, New Delhi. METHODS: Twenty-one subjects with acute, American Spinal Injury Association Impairment Scale (AIS) A (complete), traumatic SCI with neurological level T1-T12, were recruited and randomized into three groups of seven subjects each. Two groups underwent cell transplantation through the intrathecal or intralesional route, whereas the third served as control. Participants were assessed at baseline and followed up at 6 months and 12-months post enrollment. Safety and tolerability were evaluated by monitoring for any adverse events. Efficacy was assessed through neurological, functional and psychological evaluation, as well as through electrophysiological studies and urodynamics. RESULTS: Surgery was tolerated well by all participants. There were no significant adverse events attributable to the procedure. There was no significant improvement in the neurological, electrophysiological or urodynamic efficacy variables. A statistically significant improvement in functional scores as evaluated by the Spinal Cord Independence Measure and International Spinal Cord Injury Scale was observed in all groups. CONCLUSIONS: The procedure is safe and feasible in AIS A participants with thoracic-level injuries at 12-months follow-up. No efficacy could be demonstrated that could be attributed to the procedure.
