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Purpose: Ethical and legal requirements for healthcare providers in the United States, stipulate that patients sign a consent form prior to undergoing medical treatment or participating in a research study. Currently, the majority of the hospitals obtain these consents using paper-based forms, which makes patient preference data cumbersome to store, search and retrieve. To address these issues, Health Sciences of South Carolina (HSSC), a collaborative of academic medical institutions and research universities in South Carolina, is developing an electronic consenting system, the Research Permissions Management System (RPMS). This article reports the findings of a study conducted to investigate the efficacy of the two proposed interfaces for this system - an iPad-based and touchscreen-based by comparing them to the paper-based and Topaz-based systems currently in use., Methods: This study involved 50 participants: 10 hospital admission staff and 40 patients. The four systems were compared with respect to the time taken to complete the consenting process, the number of errors made by the patients, the workload experienced by the hospital staff and the subjective ratings of both patients and staff on post-test questionnaires., Results: The results from the empirical study indicated no significant differences in the time taken to complete the tasks. More importantly, the participants found the new systems more usable than the conventional methods with the registration staff experiencing the least workload in the iPad and touchscreen-based conditions and the patients experiencing more privacy and control during the consenting process with the proposed electronic systems. In addition, they indicated better comprehension and awareness of what they were signing using the new interfaces., Discussion: The results indicate the two methods proposed for capturing patient consents are at least as effective as the conventional methods, and superior in several important respects. While more research is needed, these findings suggest the viability of cautious adoption of electronic consenting systems, especially because these new systems appear to address the challenge of identifying the participants required for the complex research being conducted as the result of advances in the biomedical sciences., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Background: One mechanism to increase participation in research is to solicit potential research participants' general willingness to be recruited into clinical trials. Such research permissions and consents typically are collected on paper upon patient registration. We describe a novel method of capturing this information electronically., Purpose: The objective is to enable the collection of research permissions and informed consent data electronically to permit tracking of potential research participants' interest in current and future research involvement and to provide a foundation for facilitating the research workflow., Methods: The project involved systematic analysis focused on key areas, including existing business practices, registration processes, and permission collection workflows, and ascertaining best practices for presenting consent information to users via tablet technology and capturing permissions data. Analysis was followed by an iterative software development cycle with feedback from subject matter experts and users., Results: An initial version of the software was piloted at one institution in South Carolina for a period of 1 year, during which consents and permission were collected during 2524 registrations of patients. The captured research permission data were transmitted to a clinical data warehouse. The software was later released as an open-source package that can be adopted for use by other institutions., Limitations: There are significant ethical, legal, and informatics challenges that must be addressed at an institution to deploy such a system. We have not yet assessed the long-term impact of the system on recruitment of patients to clinical trials., Conclusions: We propose that by improving the ability to track willing potential research participants, we can improve recruitment into clinical trials and, in the process, improve patient education by introducing multimedia to informed consent documents.

Informed consents are a critical and essential component of the clinical research process. Currently, most consents and research privacy authorizations are being captured on paper. In this paper we describe a novel method of capturing this information electronically. The objective is to allow easier tracking of research participants' intent for current and future research involvement, enhance consent comprehension and facilitate the research workflow. After multidisciplinary analysis in key hospital registration areas and research participant enrollment, an open source software product was designed to capture this data through a user-friendly touch screen interface. The data may then be fed into a clinical data warehouse for use in cohort discovery or consent tracking. Despite ethical, legal and informatics challenges in clinical and research environments, we propose that this technology opens new avenues for significantly enhancing the consent process and positively impacting recruitment.

Purpose: Health information technology (HIT) is perceived as an essential component for addressing inefficiencies in healthcare. Without understanding the challenges that limit meaningful use of HIT, there is a high chance that institutions will convert complex paper-based systems to expensive digital chaos., Recent Findings: Clinical information systems do not communicate with each other automatically because integration of existing data standards is lacking. Data standards for medical specialties need further development. Database architectures are often designed to support single clinical applications and are not easily modified to meet the enterprise-wide needs desired by all end-users. Despite the improvements in charge capture and better access to health information the realized savings and impact on patient throughput is not enough to cover the cost of the technology, maintenance, and support. HIT is necessary for improved quality of care but it increases the cost of doing business. Poor user interface and system design hinders clinical workflow and can result in wasted time, poor data collection, misleading data analysis, and potentially negative clinical outcomes. Healthcare organizations have little recourse if a vendor fails to deliver as intended once the vendor's system becomes embedded into the organization. Decisions on technology acquisitions and implementations are often made by individuals or groups that lack clinical informatics expertise., Summary: Government incentives to increase HIT will likely result in a more computerized clinical environment. Understanding the challenges can help avoid costly mistakes. The future looks promising but caution is warranted, as achievement of full benefits of HIT requires addressing significant challenges.

Study Objective: To determine anesthetic drug utilization in different age groups., Design: Retrospective, automated, intraoperative database study., Setting: Tertiary care medical center., Measurements: 30,842 noncardiac general anesthesia case records between January 1991 and July 1997 were studied. We investigated the effect of age on anesthetic requirements for fentanyl (F), midazolam (M), thiopental sodium (T), propofol (P), isoflurane (I), and nitrous oxide (N). Because drugs are not given in isolation we looked at the most common drug combinations, IFNTM, IFNPM, INFT, and PFNM. Regression analyses on log-transformed drug dosages were used to test the significance of age on individual requirements., Results: In each of the above anesthetic drug combinations, reduced doses of fentanyl, propofol, midazolam, thiopental, and isoflurane were used with increasing age. Fentanyl, propofol, thiopental, and isoflurane showed a 10%, 8%, 6%, and 4% reduction in dose per decade of age, respectively, from age of maximum dose to age 80 years., Conclusions: In clinical practice, increasing age results in decreased anesthetic drug administration. The mechanism of this observation needs to be determined.

Background: Although approximately 2,000 medical practice guidelines have been proposed, few have been successfully implemented and sustained. We hypothesized that we could develop and institute practice guidelines to promote more appropriate use of costly anesthetics, to generate and sustain widespread compliance from a large physician group, and to decrease costs without adversely affecting clinical outcomes., Methods: A prospective before and after comparison study was performed at a tertiary care medical center. Clinical outcomes data and times indicative of perioperative patient flow were collected on the first of two sets of patients 1 month before discussion of practice guidelines. Practice guidelines were developed by the physicians and their associated care team for the intraoperative use of anesthetic drugs. A drug distribution process was developed to aid compliance. Clinical outcomes data and times indicative of perioperative patient flow were collected on the second set of patients 1 month after institution of practice guidelines. Hospital drug costs and adherence to guidelines were noted throughout the study period and for each of the following 9 months by querying the database of an automated anesthesia record keeper., Results: A total of 1,744 patients were studied. Drug costs decreased from 56 dollars per case to 32 dollars per case as a result of adherence to practice guidelines. Perioperative patient flow was minimally affected. Time (mean +/- SD) from end of surgery to arrival in the post-anesthesia care unit (PACU) increased from 11 +/- 7 min before the authors instituted practice guidelines to 14 +/- 8 min after practice guidelines (P < 0.0001). Admission of inpatients to the PACU receiving monitored anesthesia care increased from 6.5 to 12.9% (P < 0.02). Perioperative patient flow and clinical outcomes were not otherwise adversely affected. Compliance and cost savings have been sustained., Conclusions: This study is an example of a successful physician-directed program to promote more appropriate utilization of health care resources. Cost savings were obtained without any substantial changes in clinical outcomes. Institution of similar practice guidelines should result in pharmaceutical savings in the range of 50% at tertiary care centers around the country, with a slightly smaller degree of savings expected at institutions with more ambulatory surgery.

Anesthesia information management systems (AIMS) have uses that extend far beyond automatic anesthesia record-keeping. After initial experience with the development of monitoring technology, the Department of Anesthesiology at Duke University Medical Center, Durham, North Carolina, began the installation of the Arkive anesthesia information management system in 1987. The system was installed hospital-wide in 1992. AIMS played an integral role in determining the cost of pharmaceutical agents used during an anesthetic procedure. Clinicians targeted areas of high cost in which anesthetic practice could be modified. Establishment of an educational program followed by the institution of practice guidelines allowed for an annualized savings of more than $900,000 on drug costs with no effect on the quality of care provided. Future generations of AIMS need to be more fully integrated into hospital information management systems.

Background: Medical informatics provide a new way to evaluate the practice of medicine. Anesthesia automated record keepers have introduced anesthesiologists to computerized medical records. To derive useful information from the stored data requires programming that is not currently commercially available. The authors describe how they custom-programmed an automated record keeper's database to perform cost calculations, how they validated the programming, and how they used the data in a successful pharmaceutical cost-containment program., Methods: The Arkive (San Diego, CA) automated record keeper database was programmed at Duke University Medical Center as an independent noncommercial project to calculate costs according to standard formulae and to follow adherence to Duke University Department of Anesthesiology's prescribing guidelines for anesthetic drugs. Validation of that programming (including analysis of discarded drugs) was accomplished by comparing database calculated costs with actual pharmacy distribution of drugs during a 1-month period., Results: Validation data demonstrated a 99% accuracy rate for total costs of the drugs studied (atracurium, vecuronium, rocuronium, propofol, midazolam, fentanyl, and isoflurane). The study drugs represented approximately 67% of all drug costs for the period studied., Conclusions: Programming of an anesthesia automated record keeper's database yields essential information for management of an anesthetic practice. Accurate economic evaluation of anesthetic drug use is now possible. In the future, as definitive identification of best anesthetic practices that yield optimal patient outcomes and higher measures of patient satisfaction is pursued, large numbers of patients should be studied. This is only possible through database analysis and complete computerization of the perioperative medical record.