Faculty Bibliography

The New York City Clinical Data Research Network (NYC-CDRN), funded by the Patient-Centered Outcomes Research Institute (PCORI), brings together 22 organizations including seven independent health systems to enable patient-centered clinical research, support a national network, and facilitate learning healthcare systems. The NYC-CDRN includes a robust, collaborative governance and organizational infrastructure, which takes advantage of its participants' experience, expertise, and history of collaboration. The technical design will employ an information model to document and manage the collection and transformation of clinical data, local institutional staging areas to transform and validate data, a centralized data processing facility to aggregate and share data, and use of common standards and tools. We strive to ensure that our project is patient-centered; nurtures collaboration among all stakeholders; develops scalable solutions facilitating growth and connections; chooses simple, elegant solutions wherever possible; and explores ways to streamline the administrative and regulatory approval process across sites.

Tissue-engineered medical products are now entering the clinical testing phase of development. Therefore, an open discussion is warranted regarding ethical issues that may arise as these novel 'combination' products move forward, such as when to conduct clinical trials, how to regulate such trials, when and how to responsibly introduce these strategies into clinical practice and how to maintain a positive public perception of the tissue-engineering field as a whole. These issues are discussed, and recommendations are provided for conducting first-in-human clinical studies.

PURPOSE: Outcome reporting bias is a well-known fact in clinical research. It's critical since readers believe that published articles are reliable and accurate. METHODS: The need for investigators to register the trials at the start have made it possible to compare the content of the published article with the registered information. RESULTS: Nearly one-third of clinical trials have changed their primary outcome from the time of registration to publication. CONCLUSIONS: Editors should implement measures aimed at preventing outcome reporting bias. To this end, it is proposed that authors, when submitting a manuscript to a journal, should also submit all trial information they have posted on a registry. Authors should comment on the accuracy and completeness of the information provided in the manuscript with respect to that included on the registry. Peer review should only start after the editorial staff has checked the accuracy of the manuscript content with the trial's registered information. This straightforward, although admittedly somewhat demanding exercise for editorial staff, will help ensure the accuracy of published articles and, hence, reduce outcome reporting bias.

BACKGROUND: Older patients constitute a growing proportion of U.S. kidney transplant recipients and often have a high burden of comorbidities. A summary measure of health such as functional status might enable transplant professionals to better evaluate and counsel these patients about their prognosis after transplant. METHODS: We linked United Network for Organ Sharing registry data about posttransplantation survival with pretransplantation functional status data (physical function [PF] scale of the Medical Outcomes Study Short Form-36) among individuals undergoing kidney transplant from June 1, 2000 to May 31, 2006. We examined the relationship between survival and functional status with multivariable Cox regression, adjusted for age. Using logistic regression models for 3-year survival, we also estimated the reduction in deaths in the hypothetical scenario that recipients with poor functional status in this cohort experienced modest improvements in function. RESULTS: The cohort comprised 10,875 kidney transplant recipients with a mean age of 50 years; 14% were >/=65. Differences in 3-year mortality between highest and lowest PF groups ranged from 3% among recipients <35 years to 14% among recipients >/=65 years. In multivariable Cox regression, worse PF was associated with higher mortality (hazard ratio, 1.66 for lowest vs. highest PF quartiles; P<0.001). Interactions between PF and age were nonsignificant. We estimated that 11% fewer deaths would occur if kidney transplant recipients with the lowest functional status experienced modest improvements in function. CONCLUSIONS: Across a wide age range, functional status was an independent predictor of posttransplantation survival. Functional status assessment may be a useful tool with which to counsel patients about posttransplantation outcomes.