Prospective comparison of dysphagia following anterior cervical discectomy and fusion (ACDF) with and without rhBMP-2.

BACKGROUND CONTEXT: Previous studies have called into question the safety of using rhBMP-2 in anterior cervical fusion due to the possibility of airway compromise and dysphagia. A retrospective chart review identified a significant increase in the severity of dysphagia after II-level ACDF with rhBMP-2 compared to patients who did not receive rhBMP-2. To date, this topic has not been studied prospectively. PURPOSE: Compare the incidence of dysphagia following anterior cervical discectomy and fusion (ACDF) when recombinant human bone morphogenetic protein-2 (rhBMP-2) is used with allograft compared to allograft alone. STUDY DESIGN: Prospective cohort study. PATIENT SAMPLE: A total of 114 patients completed a baseline SWAL-QOL survey and met the inclusion criteria. Thirty-nine patients underwent I- or II-level ACDF with allograft plus 0.5mg rhBMP-2/level. 44 patients underwent ACDF with allograft alone. Thirty-one patients undergoing a lumbar decompression were enrolled in a third cohort to control for dysphagia secondary to intubation. OUTCOME MEASURES: The primary outcome measure was the 14-point SWAL-QOL dysphagia questionnaire. Other patient factors obtained from anesthesia and operative records were examined to evaluate their potential relationship to postoperative dysphagia. METHODS: The 14-point SWAL-QOL questionnaire was administered at multiple time points (pre-op, post-op 7 days, 6 weeks, 6 months, and at least 1 year). Multivariable repeated-measures analysis was applied to data. RESULTS: Baseline adjusted SWAL-QOL means 7 days after surgery were significantly different between the three study groups. These differences resolved by 6 weeks postoperative, beyond which point there were no differences. At final follow-up, baseline adjusted SWAL-QOL means at 1 year were similar for the three study groups. CONCLUSIONS: This single-center study of anterior cervical surgery demonstrated that the addition of rhBMP-2 to an ACDF increased postoperative dysphagia at 7 days after surgery, but these patients recover to levels comparable to those who underwent ACDF without rhBMP-2 or lumbar surgery within 6 weeks.

Potential benefits for caregivers of stroke survivors receiving BTX-A and exercise for upper extremity spasticity.

PURPOSE: To explore possible extended benefits to caregivers of stroke survivors receiving a treatment of onabotulinumtoxinA (BTX-A) or saline with a structured exercise program. DESIGN: A comparative, prospective, companion study using a nonrandom sample of 16 caregivers of stroke survivors enrolled in a pilot clinical trial comparing BTX-A or saline and exercise for upper extremity spasticity. METHODS: The caregiver measures were depressive symptoms, care demands, family conflict surrounding stroke recovery, and mental and physical health status. FINDINGS: There were no statistically significant differences between caregiver groups. Caregivers of stroke survivors who received BTX-A had a greater change in depressive symptoms that may reflect a clinically important change. Estimates of effect sizes between the groups, controlling for baseline values, indicate a trend for moderate to large effects (last evaluation) for fewer depressive symptoms (d = 0.52) and less caregiver burden (d = 0.77 time, 0.85 difficulty) for caregivers of the BTX-A group. CONCLUSIONS AND CLINICAL RELEVANCE: Receiving BTX-A did not alter caregiving demands or depressive symptoms compared to those receiving saline. Further research with larger sample sizes is needed to better understand the interdependence of stroke survivors and caregivers on the health of each.

Further assessment to determine the additive effect of botulinum toxin type A on an upper extremity exercise program to enhance function among individuals with chronic stroke but extensor capability.

OBJECTIVE: To determine whether dose-specified botulinum toxin type A (BTX-A) and a standardized exercise protocol produce better upper extremity function than placebo and the same exercise program. DESIGN: Double-blind randomized trial. SETTING: A rehabilitation research center. PARTICIPANTS: A convenience sample of patients (N=25, age range, 23-76 y) who sustained a stroke 3 to 24 months previously but could initiate wrist extension. INTERVENTIONS: Participants were randomly selected to receive either BTX-A (maximum 300 U) or saline, followed by 12 to 16 exercise sessions. MAIN OUTCOME MEASURES: The primary outcome was the Wolf Motor Function Test (WMFT). Secondary outcome measures included the Modified Ashworth Scale (MAS), active range of motion, and the Stroke Impact Scale (SIS; quality of life). RESULTS: There were no group-by-time interactions for changes in the WMFT and no treatment difference (P=.86), although the BTX-A group could complete more tasks governing proximal joint motions. MAS scores improved for the BTX-A group and worsened for the control group after injection (P=.02), as did the SIS emotion domain (P=.035). CONCLUSIONS: Among chronic stroke survivors, BTX-A did not impact function, movement, or tone more than a standardized exercise program.

A 7% decrease in the differential renal uptake of MAG3 implies a loss in renal function.

OBJECTIVES: To address the fact that a decrease in the relative renal uptake of 99mTc-mercaptoacetyltriglycine (MAG3) on serial MAG3 scans may indicate a loss of function and require a change in management by providing guidance as to what constitutes a meaningful change in serial relative function measurements as well determining the normal variation of other common MAG3 renogram parameters. METHODS: A prospective study was conducted in 24 male urology patients with stable renal function. The mean age was 66.5 ± 7.9 (SD) years; the mean serum creatinine was 1.38 ± 0.57 (SD) mg/dL, and the MAG3 renal scans were performed a mean of 11 ± 8 days apart. Each MAG3 scan included a measurement of relative function as well as the time to maximum counts and 20 minutes to maximum count ratios for both cortical and whole kidney regions of interest. RESULTS: The Pearson and intraclass correlations for the baseline and repeat measurements of relative renal function were both 0.98. Bland-Altman plots showed no bias between the baseline and repeat relative uptake measurements. The mean difference between 2 repeated measurements of the relative MAG3 uptake was 0.04 ± 2.88% (SD) for the left kidney and 0.08 ± 3.07% (SD) for the right kidney. Comparable results were obtained for the other renogram parameters. CONCLUSIONS: Measurements of relative renal uptake of MAG3 and common renogram parameters are highly reproducible; a decrease in relative uptake ≥7% (ie, 50%-43%) implies a loss in renal function.

Monitoring renal function: a prospective study comparing camera-based technetium-99m mercaptoacetyltriglycine clearance and creatinine clearance.

OBJECTIVES: To determine the value and limitations of technetium-99m mercaptoacetyltriglycine (MAG3) clearance measurements obtained using a gamma camera (camera-based MAG3 clearance), a prospective study was conducted to evaluate the reproducibility of camera-based MAG3 clearance compared with that of conventional creatinine clearance. METHODS: A total of 24 male patients with stable renal function were entered into the study. The mean age was 66.5 +/- 7.9 years, and the mean serum creatinine was 1.38 +/- 0.57 mg/dL. MAG3 renal scans and 24-hour creatinine clearance measurements were performed 11 +/- 8 days apart. A camera-based MAG3 clearance was obtained at each MAG3 scan; no blood samples were required. Bland-Altman plots were constructed to assist in data analysis. RESULTS: The Pearson correlation for the first and second camera-based MAG3 clearances (mean 151 versus 158 mL/min/1.73 m2, respectively) was 0.965 compared with 0.729 for the two creatinine clearance measurements (mean 62 versus 72 mL/min/1.73 m2, respectively). Even with the omission of two outliers, the creatinine clearance would have to change by 58.2% compared with the baseline measurement before the clinician could be confident the change exceeded the error of measurement. In contrast, the change required for the camera-based MAG3 clearance was 30.8%. CONCLUSIONS: The results of this study have demonstrated that MAG3 clearance obtained using a camera-based technique shows greater precision than the conventional creatinine clearance and is superior to the conventional creatinine clearance for monitoring changes in renal function.

The impact of minor adverse event tracking on subject safety: a web-based system.

BASED ON THE ASSUMPTION THAT MINOR symptoms may presage serious events, we report four years' experience with a web-based adverse event (AE) tracking system (eAETS) designed to capture AEs of a minor nature that would not meet criteria for ethical review. The eAETS has supported 175 diverse clinical protocols, is user-friendly and navigationally intuitive, and restricts access based on protocol ownership. The user creates an initial risk profile for comparison to subsequent AEs to identify unanticipated patterns. Out of 2,440 AE reports, 1,053 did not match the risk profile. Corrective modification was recommended in 6 (13%) protocols. The eAETS provides a framework for weighing the impact of AEs on subject safety.