Optimizing Telemedicine Technologic Infrastructure with Animal Models: A Case in Telecystoscopy.

Background: Rapid evolution of telemedicine technology requires procedures in telemedicine to adapt frequently. An example in urology, telecystoscopy, allows certified advanced practice providers to perform cystoscopy, endoscopic examination of the bladder, in rural areas with real-time interpretation and guidance by an off-site urologist. We have previously shown the technological infrastructure for optimized video quality. Introduction: Newer models of cystoscope and coder/decoder (codec) are available with anticipation that components used in our original model will become unavailable. Our objective is to assess the diagnostic ability of two cystoscopes (Storz, Wolf) with old (SX20) and new (DX70) codecs. Materials and Methods: A single urologist performed flexible cystoscopy on an ex vivo porcine bladder. Combinations of cystoscope (Storz vs. Wolf), codec (SX20 vs. DX70), and internet transmission speed were used to create eight distinct recordings. Deidentified videos were reviewed by expert urologist reviewers via electronic survey with questions on video quality and diagnostic ability. A logistic regression model was used to assess the ability to make a diagnosis. Results: Eight transmitted cystoscopy videos were reviewed by 16 urologists. Despite new technology, the Storz cystoscope combined with the SX20 codec (the original combination) provides the best diagnostic capacity. Discussion: Technical infrastructure must be routinely validated to assess the component impact on overall quality because newer is not always better. Should the SX20 become obsolete, ex vivo animal models are safe, inexpensive anatomic models for testing. Conclusions: As technology continues to evolve, procedures in telemedicine must critically scrutinize the impact of new technologic components to uphold quality.

Correction: Incorporating Breast Cancer Recurrence Events Into Population-Based Cancer Registries Using Medical Claims: Cohort Study.

[This corrects the article DOI: 10.2196/18143.].

Incorporating Breast Cancer Recurrence Events Into Population-Based Cancer Registries Using Medical Claims: Cohort Study.

BACKGROUND: There is a need for automated approaches to incorporate information on cancer recurrence events into population-based cancer registries. OBJECTIVE: The aim of this study is to determine the accuracy of a novel data mining algorithm to extract information from linked registry and medical claims data on the occurrence and timing of second breast cancer events (SBCE). METHODS: We used supervised data from 3092 stage I and II breast cancer cases (with 394 recurrences), diagnosed between 1993 and 2006 inclusive, of patients at Kaiser Permanente Washington and cases in the Puget Sound Cancer Surveillance System. Our goal was to classify each month after primary treatment as pre- versus post-SBCE. The prediction feature set for a given month consisted of registry variables on disease and patient characteristics related to the primary breast cancer event, as well as features based on monthly counts of diagnosis and procedure codes for the current, prior, and future months. A month was classified as post-SBCE if the predicted probability exceeded a probability threshold (PT); the predicted time of the SBCE was taken to be the month of maximum increase in the predicted probability between adjacent months. RESULTS: The Kaplan-Meier net probability of SBCE was 0.25 at 14 years. The month-level receiver operating characteristic curve on test data (20% of the data set) had an area under the curve of 0.986. The person-level predictions (at a monthly PT of 0.5) had a sensitivity of 0.89, a specificity of 0.98, a positive predictive value of 0.85, and a negative predictive value of 0.98. The corresponding median difference between the observed and predicted months of recurrence was 0 and the mean difference was 0.04 months. CONCLUSIONS: Data mining of medical claims holds promise for the streamlining of cancer registry operations to feasibly collect information about second breast cancer events.

Blinded Comparison of Clarity, Proficiency and Diagnostic Capability of Tele-Cystoscopy Compared to Traditional Cystoscopy: A Pilot Study.

PURPOSE: In order to expand the availability of cystoscopy to underserved areas we have proposed using advanced practice providers to perform cystoscopy with real-time interpretation by the urologist on a telemedicine platform, termed "tele-cystoscopy." The purpose of this study is to have blinded external reviewers retrospectively compare multisite, prospectively collected video data from tele-cystoscopy with the video of traditional cystoscopy in terms of video clarity, practitioner proficiency and diagnostic capability. MATERIALS AND METHODS: Each patient underwent tele-cystoscopy by a trained advanced practice provider and traditional cystoscopy with an onsite urologist. Prospectively collected tele-cystoscopy transmitted video, tele-cystoscopy onsite video and traditional cystoscopy video were de-identified and blinded to external reviewers. Each video was evaluated and rated twice by independent reviewers and diagnostic agreement was quantified. RESULTS: Six tele-cystoscopy encounters were reviewed for a total of 36 assessments. Video clarity, defined by speed of transmission and image resolution, was better for onsite compared to transmitted tele-cystoscopy. Practitioner proficiency for thoroughness of inspection was rated at 92% for tele-cystoscopy and 100% for traditional cystoscopy. Confidence in identification of an abnormality was equivalent. Four of 6 videos had 100% agreement between reviewers for next action taken, indicating high diagnostic agreement. Additionally, provider performing cystoscopy and location did not statistically influence the ability to make a diagnosis or action taken. CONCLUSIONS: This model has excellent completeness of examination, equivalent ability to identify abnormalities and external validation of action taken. This pilot study demonstrates that tele-cystoscopy may expand access to bladder cancer surveillance.

Optimizing and validating the technical infrastructure of a novel tele-cystoscopy system.

INTRODUCTION: Bladder cancer is the most costly malignancy to manage per capita due to the technical nature and intensity of follow-up. There are few urologists in rural areas, often necessitating that patients travel hours to receive follow-up care multiple times per year. We plan to train registered nurses and allied health professionals to perform cystoscopies which are monitored and interpreted in real-time by board-certified urologists. The key is to ensure optimal picture resolution to guarantee this technology is not inferior to traditional cystoscopy. Our objective was to develop the technical infrastructure needed for a tele-cystoscopy system through assessment of the transmitted video quality using expert reviewers and crowd-sourcing. METHODS: All combinations of the tele-cystoscopy system were systematically tested using a single Thiel cadaver. The videos were reviewed by expert urologists and general reviewers using a crowd-sourcing website. The video quality responses were assessed to determine concordance between each set of reviewers, and to determine the optimal equipment that should be selected for the tele-cystoscopy system. RESULTS: Of eight equipment combinations, only two were of high enough quality to be appropriate for medical use. We found there to be strong concordance of responses between the expert and crowd-sourced responses. The trade-offs between cost and tele-cystoscopy system component quality were compared with efficiency frontiers to elucidate the optimal system. DISCUSSION: We created and tested the feasibility of a tele-cystoscopy system that was deemed suitable for medical diagnosis by a group of experts. We further validated tele-cystoscopy video quality using both experts and recently validated crowd-sourcing.

Preclinical studies of PF-04849285, an interferon-α8 fusion protein for the treatment of HCV.

BACKGROUND: This study presents preclinical data of a novel interferon (IFN)-α8 fusion protein, PF-04849285, and compares it with IFN-α2 and pegylated IFN-α2; the latter being the current standard of care for HCV. METHODS: The antiviral properties were evaluated in vitro using the HCV replication assay (replicon) and the general encephalomyocarditis virus assay. The binding affinity to both IFNR-subunits was assessed using surface plasmon resonance. Ex vivo experiments using cynomolgus monkey and human blood were used for the evaluation of induction of IFN-inducible biomarkers (interferon inducible protein 10 [IP-10], 2'-5'-oligoadenylate synthetase [OAS2] and interleukin-6 [IL-6]). The molecule was tested intravenously and subcutaneously in cynomolgus monkey in a single dose study for two weeks at 0.01, 1, 5 and 20 mg/kg. Each route and dose combination was given to a single male animal, blood samples were collected for evaluation of biomarkers and pharmacokinetics. The compound was also tested in cynomolgus monkey in a multiple dose study for four weeks, with a twice-a-week dosing prior to a three-week wash-out period for toxicokinetics, pharmacokinetics, and biomarker evaluation at 20, 50 or 100 mg/kg subcutaneously and 20 mg/kg intravenously. RESULTS: The molecule is 10× more potent than the pegylated IFN-α2a, with potency similar to the unmodified IFN-α2a. No unanticipated findings were observed in cynomolgus monkey when dosed up to 20 mg/kg, >10,000-fold margin over the anticipated efficacious human dose. CONCLUSIONS: The biomarker and toxicological findings were consistent with a potent IFN molecule. The potency and pharmacokinetic properties of the molecule are consistent with dosing at least every two weeks with the potential for monthly dosing' and not 'at least twice daily' as presented in the original [corrected].