Internet-Based Patient Survey on Urolithiasis Treatment and Patient Satisfaction.

PURPOSE: We created an Internet-based survey of patients treated for urolithiasis to evaluate for trends in treatment, outcome, and patient satisfaction and to establish internet surveys as a feasible medium for future research of patient urolithiasis treatment experiences. MATERIALS AND METHODS: We used the website "kidneystoners.org" to disseminate the online survey, which queried respondents on treatment type, outcome, and satisfaction. Patient satisfaction was correlated with treatment type and outcome. Chi-square and analysis of variance tests were used to compare responses between treatment types. RESULTS: Four hundred forty-three respondents completed the survey. The majority (46%) were treated ureteroscopically, followed by extracorporeal shock wave lithotripsy (SWL, 25%) and percutaneous nephrolithotomy (7%). Other treatments included spontaneous passage (13%), medical expulsive therapy (7%), and home remedies (2%). Sixty-four percent of respondents deemed their treatment "successful," while 36% reported their treatment as either "partially successful" or "unsuccessful." Unsuccessful treatment was more likely for SWL (17%) and home remedies (14%) (p=0.002). Most respondents (52%) reported being either satisfied or very satisfied with their treatment choice. Satisfaction did not vary significantly by treatment type, but was significantly associated with treatment success (mean satisfaction 3.8/5 for "successful" vs 1.9/5 for "unsuccessful" treatment; p<0.0001). CONCLUSION: Use of the Internet allows rapid gathering of patient information from a large geographic distribution. Our survey is consistent with previous studies in demonstrating an increased use of ureteroscopy to treat both renal and ureteral calculi. In general, patients are satisfied with treatment outcomes despite a large percentage of people reporting needing to have secondary procedures.

Randomized, double-blind, placebo-controlled trial of polyphenon E in prostate cancer patients before prostatectomy: evaluation of potential chemopreventive activities.

Compelling preclinical and pilot clinical data support the role of green tea polyphenols in prostate cancer prevention. We conducted a randomized, double-blind, placebo-controlled trial of polyphenon E (enriched green tea polyphenol extract) in men with prostate cancer scheduled to undergo radical prostatectomy. The study aimed to determine the bioavailability of green tea polyphenols in prostate tissue and to measure its effects on systemic and tissue biomarkers of prostate cancer carcinogenesis. Participants received either polyphenon E (containing 800 mg epigallocatechin gallate) or placebo daily for 3 to 6 weeks before surgery. Following the intervention, green tea polyphenol levels in the prostatectomy tissue were low to undetectable. Polyphenon E intervention resulted in favorable but not statistically significant changes in serum prostate-specific antigen, serum insulin-like growth factor axis, and oxidative DNA damage in blood leukocytes. Tissue biomarkers of cell proliferation, apoptosis, and angiogenesis in the prostatectomy tissue did not differ between the treatment arms. The proportion of subjects who had a decrease in Gleason score between biopsy and surgical specimens was greater in those on polyphenon E but was not statistically significant. The study's findings of low bioavailability and/or bioaccumulation of green tea polyphenols in prostate tissue and statistically insignificant changes in systemic and tissue biomarkers from 3 to 6 weeks of administration suggests that prostate cancer preventive activity of green tea polyphenols, if occurring, may be through indirect means and/or that the activity may need to be evaluated with longer intervention durations, repeated dosing, or in patients at earlier stages of the disease.

An immunologic model for rapid vaccine assessment -- a clinical trial in a test tube.

While the duration and size of human clinical trials may be difficult to reduce, there are several parameters in pre-clinical vaccine development that may be possible to further optimise. By increasing the accuracy of the models used for pre-clinical vaccine testing, it should be possible to increase the probability that any particular vaccine candidate will be successful in human trials. In addition, an improved model will allow the collection of increasingly more-informative data in pre-clinical tests, thus aiding the rational design and formulation of candidates entered into clinical evaluation. An acceleration and increase in sophistication of pre-clinical vaccine development will thus require the advent of more physiologically-accurate models of the human immune system, coupled with substantial advances in the mechanistic understanding of vaccine efficacy, achieved by using this model. We believe the best viable option available is to use human cells and/or tissues in a functional in vitro model of human physiology. Not only will this more accurately model human diseases, it will also eliminate any ethical, moral and scientific issues involved with use of live humans and animals. An in vitro model, termed "MIMIC" (Modular IMmune In vitro Construct), was designed and developed to reflect the human immune system in a well-based format. The MIMIC System is a laboratory-based methodology that replicates the human immune system response. It is highly automated, and can be used to simulate a clinical trial for a diverse population, without putting human subjects at risk. The MIMIC System uses the circulating immune cells of individual donors to recapitulate each individual human immune response by maintaining the autonomy of the donor. Thus, an in vitro test system has been created that is functionally equivalent to the donor's own immune system and is designed to respond in a similar manner to the in vivo response.