Multi-Institutional Registry for Prostate Cancer Radiosurgery: A Prospective Observational Clinical Trial

Title: Multi-institutional Registry for Prostate Cancer Radiosurgery: An Observational Clinical TrialAuthors: Debra Freeman, MD*; Gregg Dickerson, MD; Mark Perman, MDObjective: To report on the design, methodology and early outcome results of a multi-institutional registry study of prostate cancer radiosurgery.Methods: The Registry for Prostate Cancer Radiosurgery (RPCR) was established in 2010 to further evaluate the efficacy and toxicity of prostate radiosurgery (SBRT) for the treatment of clinically localized prostate cancer. Men with prostate cancer were asked to voluntarily participate in the Registry. Demographic, baseline medical and treatment-related data were collected and stored electronically in a HIPAA-compliant database, maintained by Advertek, Inc. Enrolled men were asked to complete short, multiple choice questionnaires regarding their bowel, bladder and sexual function. Patient-reported outcome forms were collected at baseline and at regular intervals (every 3-6 months) following treatment. Serial PSA measurements were obtained at each visit and included in the collected data.Results: From July 2010 to July 2013, nearly 2000 men from 45 participating sites were enrolled in the registry. The majority (86%) received radiosurgery as monotherapy. At 2 years follow-up, biochemical disease free survival was 92%. No Grade 3 late urinary toxicity was reported. One patient developed Grade 3 gastrointestinal toxicity (rectal bleeding). Erectile function was preserved in 80% of men <70 yeats old. Overall compliance with data entry was 64%.Conclusion: Stereotactic radiosurgery is an alternative option to conventional radiotherapy for the treatment of organ-confined prostate cancer. The Registry for Prostate Cancer Radiosurgery represents the collective experience of multiple institutions, including community-based cancer centers, with outcome results in keeping with published, prospective trials of prostate SBRT

Validation of a new method for estimating resting energy expenditure of non-ambulatory tube-fed patients with severe neurodevelopmental disabilities

OBJECTIVE: We assessed the bias and precision of the Arlington Developmental Center (ADC) equations derived from our previous study and the Harris-Benedict equations for estimating resting energy expenditure in non-ambulatory, tube-fed patients with severe neurodevelopmental disabilities. METHODS: Fifteen non-ambulatory patients with neurodevelopmental disabilities referred to the nutrition consult service for evaluation of enteral tube feeding via a permanent ostomy who had a steady-state resting energy expenditure measurement performed by indirect calorimetry were included in the study. The predicted energy expenditure values were compared with the measured resting energy expenditure values and evaluated for bias and precision. RESULTS: Both ADC equations were more precise (95% confidence interval [CI]: 9-22% and 10-18% error, respectively) for the total population than the Harris-Benedict equations (95% CI: 17-40% error). The ADC-2 equation was precise (95% CI: 7-15% error) and unbiased (95% CI: -5 to 139 kcal/d) in contrast to the Harris-Benedict equations (95% CI: 23-54% error; bias, +230 to 365 kcal/d) for patients with cerebral palsy and fixed upper extremity contractures. The Harris-Benedict equations were precise and unbiased (95% CI: 3-14% error; bias, -182 to 39 kcal/d) for patients with cerebral palsy with preservation of upper body movement, whereas the ADC equations were biased toward underprediction and associated with greater error (95% CI: -367 to -73 kcal/d and 7-26% error; 95% CI: -379 to -109 kcal/d and 9-27% error, respectively). CONCLUSIONS: The ADC-2 equation was unbiased and more precise in non-ambulatory adult patients with severe neurodevelopmental disabilities and fixed upper extremity contractures, whereas the Harris-Benedict equations were more precise and unbiased for those with preservation of limited functional and non-functional upper extremity movement

Effect of upper extremity posturing on measured resting energy expenditure of nonambulatory tube-fed adult patients with severe neurodevelopmental disabilities

PURPOSE: To ascertain the effect of upper extremity posturing on measured resting energy expenditure (MEE) for patients with severe neurodevelopmental disabilities. METHODS: Twenty-four nonambulatory adult patients with severe neurodevelopmental disabilities referred for evaluation of enteral tube feeding and who had a steady-state MEE performed were studied. Steady-state indirect calorimetry measurements were done through a canopy system. Patients were stratified according to the topography of their neuromotor impairment and motor function as having either fixed upper extremity contractures (Fixed UE) or with preservation of limited functional and nonfunctional upper extremity movement (Preserved UE). RESULTS: Despite a similar age, weight, height, and gender distribution between groups, those patients with Fixed UE (n = 13) had a significantly lower MEE than those with Preserved UE (n = 11): 893 +/- 91 versus 1144 +/- 262 kcal/d (p \u3c .01), respectively. The Harris-Benedict equations\u27 predicted energy expenditures were similar to MEE for patients with Preserved UE (1212 +/- 156 versus 1144 +/- 262 kcal/d, respectively, p = N.S.). Patients with Fixed UE had a significantly lower MEE than predicted by the Harris-Benedict equations (893 +/- 91 versus 1128 +/- 123 kcal/d, respectively, p \u3c .01) CONCLUSIONS: Patients with fixed upper extremity contractures have a significantly lower MEE than those with preserved upper extremity movement. MEE for nonambulatory tube-fed adult patients with severe neurodevelopmental disabilities and fixed upper extremity contractures is significantly lower than predicted by the Harris-Benedict equations

Topiramate and weight loss in patients with neurodevelopmental disabilities

STUDY OBJECTIVE: To characterize weight changes in patients with neurodevelopmental disabilities who received topiramate. DESIGN: Retrospective, observational study. SETTING: State-supported developmental center. PATIENTS: Fifteen patients with neurodevelopmental disabilities who received topiramate therapy MEASUREMENTS AND MAIN RESULTS: Monthly weights for 1 year after the start of topiramate therapy were recorded. Mean body weight at drug initiation differed significantly compared with the nadir weight during the next 12 months (52.2+/-7.5 vs 49.9+/-7.2 kg, p\u3c0.02). Twelve patients who were receiving ad libitum oral diets demonstrated a significant decrease in body weight (52.1+/-7.5 vs 49.0+/-7.3 kg, p\u3c0.01), whereas the three patients who received enteral nutrition through enterostomy did not experience significant weight loss. CONCLUSION: Weight loss is common in patients with neurodevelopmental disabilities who receive topiramate. Since patients who received oral diets lost weight whereas those receiving enteral nutrition did not, decreased nutrient intake is the likely cause of weight loss