Quantitative assessment of oral phase efficiency: validation of the Test of Masticating and Swallowing Solids (TOMASS).

BACKGROUND: The Test of Masticating and Swallowing Solids (TOMASS) has been developed to provide clinicians with objective data regarding the efficiency of oral phase function and solid bolus ingestion. AIMS: To determine if the TOMASS will detect changes in the oral phase of swallowing imposed by topical anaesthesia, thus providing validation of its clinical utility. METHODS & PROCEDURES: Per the standard protocol, 10 healthy participants ate one-quarter of an Arnotts SaladaTM biscuit. The number of bites per cracker, number of masticatory cycles, number of swallows and total time taken were recorded at baseline, following application of topical oral anaesthetic; this was additionally compared with a post-anaesthetic condition. Median and interquartile range (IQR) were calculated. Wilcoxon signed-rank tests were conducted to evaluate trial effect, and Friedman's tests were used to detect differences in the number of bites, number of swallows, number of chews and time taken to eat the crackers. OUTCOMES & RESULTS: Results indicated that the number of both bites and swallows did not significantly change across conditions (χ²(2) = 0.105, p = 0.949, χ²(2) = 1.357, p = 0.507); however, the number of chews for the anaesthetic condition was significantly higher when compared with the baseline (p = 0.02) and post-anaesthesia conditions (p = 0.02). Further, the durations of ingestion in the anaesthetic condition were significantly longer than the baseline (p = 0.01) and post-anaesthesia (p = 0.01) conditions. Across all measures, there were no differences between baseline and post-anaesthesia conditions. CONCLUSIONS & IMPLICATIONS: Although further exploration is required, these early data suggest the TOMASS is a sensitive measure in the evaluation of the oral-phase preparation of solid textures.

The Test of Masticating and Swallowing Solids (TOMASS): reliability, validity and international normative data.

BACKGROUND: Clinical swallowing assessment is largely limited to qualitative assessment of behavioural observations. There are limited quantitative data that can be compared with a healthy population for identification of impairment. The Test of Masticating and Swallowing Solids (TOMASS) was developed as a quantitative assessment of solid bolus ingestion. AIMS: This research programme investigated test development indices and established normative data for the TOMASS to support translation to clinical dysphagia assessment. METHODS & PROCEDURES: A total of 228 healthy adults (ages 20-80+ years) stratified by age and sex participated in one or more of four consecutive studies evaluating test-retest and interrater reliability and validity to instrumental assessment. For each study the test required participants to ingest a commercially available cracker with instructions to 'eat this as quickly as is comfortably possible'. Further averaged measures were derived including the number of masticatory cycles and swallows per bite, and time per bite, masticatory cycle and swallow. Initial analyses identified significant differences on salient measures between two commercially available crackers that are nearly identical in shape, size and ingredients, suggesting the need for separate normative samples for specific regional products. Additional analyses on a single cracker identified that the TOMASS was sensitive at detecting changes in performance based on age and sex. Test-retest reliability across days and interrater reliability between clinicians was high, as was validation of observational measures to instrumental correlates of the same behaviours. Therefore, normative data are provided for the TOMASS from a minimum of 80 healthy controls, stratified by age and sex, for each of seven commercially available crackers from broad regions worldwide. OUTCOMES & RESULTS: Analyses on a single cracker identified Arnott's Salada, and that TOMASS measures were sensitive for detecting changes in performance based on age and sex. Interrater and test-retest reliability across days were high, as was validation of observational measures to instrumental correlates of the same behaviours. Significant differences were identified between two commercially available crackers, nearly identical in shape, size and ingredients, thus normative samples for specific regional products were required. Normative data were then acquired for the TOMASS from a minimum of 80 healthy controls, stratified by age and sex, for each of seven commercially available crackers from broad regions worldwide. CONCLUSIONS & IMPLICATIONS: The TOMASS is presented as a valid, reliable and broadly normed clinical assessment of solid bolus ingestion. Clinical application may help identify dysphagic patients at bedside and provide a non-invasive, but sensitive, measure of functional change in swallowing.

Long-term Outcomes of 2-Level Total Disc Replacement Using ProDisc-L: Nine- to 10-Year Follow-up.

STUDY DESIGN: A prospective clinical data analysis. OBJECTIVE: To determine the long-term clinical success of 2-level total disc replacement (TDR) in patients with degenerative disc disease. SUMMARY OF BACKGROUND DATA: Early successful clinical results of 2-level TDR have been reported. Few studies exist that have described this procedure's durability in the long term. METHODS: Fifteen patients underwent 2-level lumbar TDR with the ProDisc-L as part of a randomized trial, 13 of whom were available for follow-up. The patients were assessed preoperatively and at 2 years, 5 years, and more than 9 years postoperatively using visual Oswestry Disability Index. At the last follow-up visit, 2 additional questions were asked: satisfaction with surgery and willingness to undergo the same treatment. Finally, clinical success was assessed using a previously described definition. RESULTS: Mean follow-up time was 9.6 years (range, 9.2-10.3 yr). Postoperatively there was a significant improvement in Oswestry Disability Index score from baseline (70.0 vs. 15.7 at 2 yr, P = 0.002) that remained unchanged during the period of follow-up (19.8 at 5 yr, P = 0.003 and 12.9 at 9-10 yr, P = 0.002). Ninety-two percent of patients were "satisfied" or "somewhat satisfied" with treatment and the same number would undergo treatment again. Eighty-five percent of patients achieved clinical success. CONCLUSION: This prospective study demonstrates the durable clinical success of 2-level lumbar TDR as assessed at more than 9 years postoperatively. LEVEL OF EVIDENCE: 4.

Evaluation of spinal kinematics following lumbar total disc replacement and circumferential fusion using in vivo fluoroscopy.

STUDY DESIGN: In vivo fluoroscopic analysis of lumbar spinal motion with total disc replacement (TDR), fusions, and controls. OBJECTIVES: Compare and contrast lumbar spinal motion profiles in TDR, circumferential fusion, and controls. SUMMARY OF BACKGROUND DATA: TDR has been shown to preserve motion and possibly prevent abnormal loading at the adjacent level. Although in vitro cadaveric studies have provided invaluable information, they are not capable of assessing the physiologic motion profile of the lumbar spine that is initiated and stabilized by in vivo trunk muscular contractions. METHODS: Cross-sectional evaluation using high-frequency low-dose pulsated video fluoroscopy to evaluate lumbar spinal motion in subjects who underwent TDR (n = 8), circumferential fusion (n = 5), and controls (n = 4). Angulation and translation were recorded at 20 time points during the extension-flexion arc. Motion gradients, or slopes of the motion curves, were generated to allow for comparison of lumbar spinal motion profiles. RESULTS: Circumferential fusions exhibited significantly steeper motion gradients at the proximal adjacent level compared with TDR during flexion. TDR had more physiologic motion profiles at the proximal adjacent level than fusions during flexion and extension. At operative levels L4/5 and L5/S1, TDR and controls exhibited similar motion profiles in flexion, while fusions exhibited significantly less motion. In extension, however, TDR had a steeper slope than controls at the L4/5 operative level. Between L3 and S1, the total range of motion accounted for by the L4/5 proximal adjacent level was 59% in 1-level fusions, 38% in 1-level TDR, and 29% in controls. While no control or TDR subjects underwent sagittal plane translation >3 mm during flexion-extension, 80% of fusions did (average 3.7 mm), most notably during the latter phase of extension. CONCLUSIONS: TDR produces physiologic lumbar spinal motion profiles in flexion and extension at the operative and proximal adjacent levels. Fusions, however, produced steeper motion gradients at the proximal adjacent level, while undergoing significantly greater sagittal plane translation during flexion-extension.