Iain C. Sanderson

The Successful Implementation of Pharmaceutical Practice Guidelines Analysis of Associated Outcomes and Cost Savings

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.

Using an anesthesia information management system as a cost containment tool: Description and validation

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 keepers 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 Anesthesiologys 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 keepers 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.

An investigation of the efficacy of electronic consenting interfaces of research permissions management system in a hospital setting

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.

The Future of Cardiovascular Clinical Research: Informatics, Clinical Investigators, and Community Engagement

SUBSTANTIAL AGE-ADJUSTED REDUCTIONS IN CARDIOvascular mortality and morbidity over the past few decades are being challenged by increases in physical inactivity, diabetes mellitus, and obesity, creating a large and aging population with long-term cardiovascular disease (CVD). However, the US national investments in discovery and translational science continue to produce major advances, both in understanding these conditions at the cellular level and in development of therapeutic and diagnostic tools that can improve health outcomes. Innovative research and clinical opportunities may arise from the ability to combine clinical and geospatial data at the regional scale in large, integrated health care delivery systems. The concept of a “learning health system” can be advanced if this capacity is coupled with the ability to perform practical clinical trials and comparative effectiveness research, using the results to further improve health and health care. Such integrated systems promise a common approach to issues that previously seemed irreconcilable: personalized medicine vs population health, traditional medicine vs public health. The CVD epidemic is particularly amenable to this approach because of its magnitude, the advanced understanding of its biological and social basis, and the availability of effective treatments. Reductions in cardiovascular morbidity and mortality, however, will depend on enhanced individual and community engagement with the research enterprise. The advent of electronic health records (EHRs) in the 1970s created expectations, but the challenges of human interfaces in these early systems, coupled with a lack of terminology standards and limited computational power for large data sets, restricted electronic data capture to specialized applications: simply collecting data in one place was a major task. After 3 decades of technological progress, population clinical data sets for research are more widely available, and the major challenges are (1) organizing data into information, (2) analyzing information to distill actionable knowledge, and (3) presenting knowledge in ways that can inform personal or policy decisions. Debate continues about how current EHR user interfaces help or hinder patient outcomes. However, the overall efficiency of medicine and the rational basis for decision making will be enhanced as the practical issues of integrating data, information, and knowledge into clinical care and public health practice are solved. Two projects provide examples of the potential of this approach. These efforts integrate clinical and geospatially mapped data with the purpose of improving individual and population health in geographically defined regions, accelerating the rate at which reliable evidence can be generated to support rational decision making. This work is predicated on informatics-driven approaches to the disciplined collection of structured data as part of routine clinical practice and to aggregating those data in novel ways that enable multiple uses. The first project is based in Durham County, North Carolina, and uses geospatial methods to connect clinical data from Duke Medicine, the Durham County Health Department, and Lincoln Community Health Center (Durham’s Federally Qualified Health Center) with data on housing, neighborhoods, social stressors, environmental exposures, and culture. This allows researchers and clinicians to understand patients both from their medical records and from the social and environmental contexts in which they live, work, and play. This project also has engaged the Durham community in a direct conversation about how the composite influences of human biology and social and environmental influences shape individual and population health, as well as how this knowledge can and should be used to develop tailored, community-based interventions that improve individual and population health. The second project builds on this approach but focuses particularly on adults living with type 2 diabetes mellitus and extends the work to other counties in North Carolina, Mississippi, and West Virginia.

Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents

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.

Use of an Automated Anesthesia Information System to Determine Reference Limits for Vital Signs During Cesarean Section

Introduction. We evaluated whether automated anesthesia information systems can be used to calculate reference limits (population-based “normal values”) for vital signs. We considered four populations of women undergoing cesarean section: healthy under spinal anesthesia, healthy under general anesthesia, pre-eclamptic/eclamptic under spinal anesthesia, and pre-eclamptic/eclamptic under general anesthesia. Methods. Reference limits were calculated for each of the study populations by determination of percentiles for: minimum heart rate, maximum heart rate, minimum arterial oxyhemoglobin saturation (SaO2), minimum mean arterial pressure (MAP), maximum MAP, decrease in MAP, and increase in MAP. Results.There was one adverse anesthetic outcome among the 1,300 women in the study; the woman sustained a post-dural puncture headache. The 5th percentiles of SaO2 were at least 95% saturation under spinal versus90% under general. Under spinal anesthesia, 95th percentiles for decreases in MAP from baseline were 63 mmHg for healthy and 75 mmHg for pre-eclamptic/eclamptic women. Under general anesthesia, the 95th percentiles for maximum MAP were 161 and 177 mmHg, respectively. Two women of the 1,300 patients experienced simultaneously a minimum SaO2 <92% and minimum MAP <50 mmHg. Discussion. Automated anesthesia information systems can be used to determine reference limits for vital signs during anesthesia. Reference limits may play a role in malpractice cases when an expert claims that care by an anesthesiologist was sub-standard as shown by vital signs that were not maintained within the normal range during the critical portions of an anesthetic. Automated anesthesia information systems may enhance expert witnesses’ clinical judgment.

Audit commission tackles anaesthetic services. Anaesthesia should remain physician based service.

Editor—We read with interest the articles1,2 that you recently published in response to the Audit Commission’s Anaesthesia under Examination,3 which revisits the topic of nurse anaesthetists. We trained as anaesthetists in the United Kingdom but now work in the United States. Nurse anaesthetists in the United States always work under the direction of a physician and, despite our initial reservations, we have all been pleasantly surprised by the experience of working with this highly qualified group of professionals. Minimal requirements for entry to the training programmes of two to three years are a nursing or basic science college degree and one year’s experience in critical care nursing. Fear of unemployment in recent years has produced a sharp fall in applications to anaesthesia residency programmes.4 Most programmes have downsized, and a few have closed altogether. Rather than appoint more consultants, many hospitals have recruited nurse anaesthetists to meet their commitments—an expensive solution as salaries for nurse anaesthetists, which average £50 000, are more than twice those of residents. The US Health Care Financing Administration recently announced a proposal to eliminate the federal requirement for supervision of nurse anaesthetists by physicians. This move is being supported by the American Association of Nurse Anesthetists. If approved, the proposal could allow independent practice in some states. The American Society of Anesthesiologists has urged its members to respond “vigorously” to the proposal. Why can’t nurses be a part of anaesthesia in Britain? The simple answer is: “It’s too late.” Assuming that a pool of sufficiently trained and motivated nurses who are willing to take up the challenge actually exists, will there be any jobs for them by the time they emerge from training? Who should train and accredit nurse anaesthetists—and could recruitment to nurse anaesthesia deprive other areas of its skilled practitioners? Unlike his or her American counterpart, the average British trainee in anaesthesia often works with little or no supervision. British trainees are paid less than their regular rates of pay for contractual overtime. We believe that it is unlikely that nurses would tolerate being used to replace trainees in anaesthesia under the same conditions. Employing nurses as replacements for consultants, which could conceivably happen in the United States, would threaten the fundamental involvement of the practice of medicine in anaesthesia. The practice of anaesthesia is much more than the administration of anaesthetics and for this reason anaesthesia should remain, at least in the United Kingdom, a physician based service.

Utilization of the EPIC Electronic Health Record System for Clinical Trials Management at Duke University

Academic Medical Centers continually struggle with clinical trials study management. A common approach is the implementation of a Clinical Trials Management System. However, integration of the Clinical Trials Management System with the health systems Electronic Health Record System remains a goal of many institutions. Furthermore, adopting the Electronic Health Record as the primary study management mechanism for research is challenging but offers many improvements in data integrity, compliance and revenue billing management.

A comparative effectiveness study of eSource used for data capture for a clinical research registry

Objective This pilot study compared eSource-enabled versus traditional manual data transcription (non-eSource methods) for the collection of clinical registry information. The primary study objective was to compare the time spent completing registry forms using eSource versus non-eSource methods The secondary objectives were to compare data quality associated with these two data capture methods and the flexibility of the workflows. This study directly addressed fundamental questions relating to eSource adoption: what time-savings can be realized, and to what extent does eSource improve data quality. Materials and methods The study used time and motion methods to compare eSource versus non-eSource data capture workflows for a single center OB/GYN registry. Direct observation by industrial engineers using specialized computer software captured keystrokes, mouse clicks and video recordings of the study team in their normal work environment completing real-time data collection. Results The overall average data capture time was reduced with eSource versus non-eSource methods (difference, 151 s per case; eSource, 1603 s; non-eSource, 1754 s; p = 0.051). The average data capture time for the demographic data was reduced (difference, 79 s per case; eSource, 133 s; non-eSource, 213 s; p < 0.001). This represents a 37% time reduction (95% confidence interval 27% to 47%). eSourced data field transcription errors were also reduced (eSource, 0%; non-eSource, 9%). Conclusion The use of eSource versus traditional data transcription was associated with a significant reduction in data entry time and data quality errors. Further studies in other settings are needed to validate these results.

Using an Anesthesia Information Management System as a Cost Containment Tool: Description and Validation

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 keepers 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(R) (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 Anesthesiologys 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 keepers 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.