Robotic eTEP versus IPOM evaluation: the REVEAL multicenter randomized clinical trial

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Abstract

For small to medium-sized ventral hernias, robotic intraperitoneal onlay mesh (rIPOM) and enhanced-view totally extraperitoneal (eTEP) repair have emerged as acceptable approaches that each takes advantage of robotic instrumentation. We hypothesized that avoiding mesh fixation in a robotic eTEP repair offers an advantage in early postoperative pain compared to rIPOM.

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Most cited references 24

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Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

Paul A. Harris, Robert Taylor, Robert Thielke … (2009)

Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.

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The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years.

David Cella, Susan Yount, Nan Rothrock … (2007)

The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Roadmap initiative (www.nihpromis.org) is a 5-year cooperative group program of research designed to develop, validate, and standardize item banks to measure patient-reported outcomes (PROs) relevant across common medical conditions. In this article, we will summarize the organization and scientific activity of the PROMIS network during its first 2 years. The network consists of 6 primary research sites (PRSs), a statistical coordinating center (SCC), and NIH research scientists. Governed by a steering committee, the network is organized into functional subcommittees and working groups. In the first year, we created an item library and activated 3 interacting protocols: Domain Mapping, Archival Data Analysis, and Qualitative Item Review (QIR). In the second year, we developed and initiated testing of item banks covering 5 broad domains of self-reported health. The domain mapping process is built on the World Health Organization (WHO) framework of physical, mental, and social health. From this framework, pain, fatigue, emotional distress, physical functioning, social role participation, and global health perceptions were selected for the first wave of testing. Item response theory (IRT)-based analysis of 11 large datasets supplemented and informed item-level qualitative review of nearly 7000 items from available PRO measures in the item library. Items were selected for rewriting or creation with further detailed review before the first round of testing in the general population and target patient populations. The NIH PROMIS network derived a consensus-based framework for self-reported health, systematically reviewed available instruments and datasets that address the initial PROMIS domains. Qualitative item research led to the first wave of network testing which began in the second year.

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A comparison of pain rating scales by sampling from clinical trial data.

Soren Skovlund, K Breivik, A Bjornsson (2000)

The goals of this study were to examine agreement and estimate differences in sensitivity between pain assessment scales. Multiple simultaneous pain assessments by patients in acute pain after oral surgery were used to compare a four-category verbal rating scale (VRS-4) and an 11-point numeric rating scale (NRS-11) with a 100-mm visual analog scale (VAS). The sensitivity of the scales (i.e., their ability [power] to detect differences between treatments) was compared in a simulation model by sampling from true pairs of observations using varying treatment differences of predetermined size. There was considerable variability in VAS scores within each VRS-4 or NRS-11 category both between patients and for repeated measures from the same patient. Simulation experiments showed that the VAS was systematically more powerful than the VRS-4 in all simulations performed. The sensitivity of the VAS and NRS-11 was approximately equal. In this acute pain model, the VRS-4 was less sensitive than the VAS. The simulation results demonstrated similar sensitivity of the NRS-11 and VAS when comparing acute postoperative pain intensity. The choice between the VAS and NRS-11 can thus be based on subjective preferences.