Katherine A. Sward

A replicable method for blood glucose control in critically Ill patients.

Context:To ensure interpretability and replicability of clinical experiments, methods must be adequately explicit and should elicit the same decision from different clinicians who comply with the study protocol. Objective:The objective of this study was to determine whether clinician compliance with protocol recommendations exceeds 90%. Design:We developed an adequately explicit computerized protocol (eProtocol-insulin) for managing critically ill adult patient blood glucose. We monitored clinician compliance with eProtocol-insulin recommendations in four intensive care units in four hospitals and compared blood glucose distributions with those of a simple clinical guideline at one hospital and a paper-based protocol at another. All protocols and the guideline used intravenous insulin and 80 to 110 mg/dL (4.4–6.1 mmol/L) blood glucose targets. Setting:The setting for this study was four academic hospital intensive care units. Patients:This study included critically ill adults requiring intravenous insulin. Intervention:Intervention used in this study was a bedside computerized protocol for managing blood glucose. Main Outcome Measure:The main outcome measure was clinician compliance with eProtocol-insulin recommendations. Results:The number of patients was 31 to 458 and the number of blood glucose measurements was 2,226 to 19,925 among the four intensive care units. Clinician compliance with eProtocol-insulin recommendations was 91% to 98%. Blood glucose distributions were similar in the four hospitals (generalized linear model p = .18). Compared with the simple guideline, eProtocol-insulin glucose measurements within target increased from 21% to 39%, and mean blood glucose decreased from 142 to 115 mg/dL (generalized linear model p < .001). Compared with the paper-based protocol, eProtocol-insulin glucose measurements within target increased from 28% to 42%, and mean blood glucose decreased from 134 to 116 mg/dL (generalized linear model p = .001). Conclusions:The 91% to 98% clinician compliance indicates eProtocol-insulin is an exportable instrument that can establish a replicable experimental method for clinical trials of blood glucose management in critically ill adults. Control of blood glucose was better with eProtocol-insulin than with a simple clinical guideline or a paper-based protocol.

Multicenter Validation of a Computer-Based Clinical Decision Support Tool for Glucose Control in Adult and Pediatric Intensive Care Units

Introduction: Hyperglycemia during critical illness is common, and intravenous insulin therapy (IIT) to normalize blood glucose improves outcomes in selected populations. Methods differ widely in complexity, insulin dosing approaches, efficacy, and rates of hypoglycemia. We developed a simple bedside-computerized decision support protocol (eProtocol-insulin) that yields promising results in the development center. We examined the effectiveness and safety of this tool in six adult and five pediatric intensive care units (ICUs) in other centers. Methods: We required attending physicians of eligible patients to independently intend to use intravenous insulin to normalize blood glucose. We used eProtocol-insulin for glucose control for a duration determined by the clinical caregivers. Adults had an anticipated length of stay of 3 or more days. In pediatric ICUs, we also required support or intended support with mechanical ventilation for greater than 24 hours or with a vasoactive infusion. We recorded all instances in which eProtocol-insulin instructions were not accepted and all blood glucose values. An independent data safety and monitoring board monitored study results and subject safety. Bedside nurses were selected randomly to complete a paper survey describing their perceptions of quality of care and workload related to eProtocol-insulin use. Results: Clinicians accepted 93% of eProtocol-insulin instructions (11,773/12,645) in 100 adult and 48 pediatric subjects. Forty-eight percent of glucose values were in the target range. Both of these results met a priori-defined efficacy thresholds. Only 0.18% of glucose values were ≤40 mg/dl. This is lower than values reported in prior IIT studies. Although nurses reported eProtocol-insulin required as much work as managing a mechanical ventilator, most nurses felt eProtocol-insulin had a low impact on their ability to complete non-IIT nursing activities. Conclusions: A multicenter validation demonstrated that eProtocol-insulin is a valid, exportable tool that can assist clinicians in achieving control of glucose in critically ill adults and children.

Philosophical approaches to the nursing informatics data-information-knowledge-wisdom framework.

Although informatics is an important area of nursing inquiry and practice, few scholars have articulated the philosophical foundations of the field or how these translate into practice including the often-cited data, information, knowledge, and wisdom (DIKW) framework. Data, information, and knowledge, often approached through postpositivism, can be exhibited in computer systems. Wisdom aligns with constructivist epistemological perspectives such as Gadamerian hermeneutics. Computer systems can support wisdom development. Wisdom is an important element of the DIKW framework and adds value to the role of nursing informaticists and nursing science.

Fatal and Near-Fatal Asthma in Children: The Critical Care Perspective

OBJECTIVE To characterize the clinical course, therapies, and outcomes of children with fatal and near-fatal asthma admitted to pediatric intensive care units (PICUs). STUDY DESIGN This was a retrospective chart abstraction across the 8 tertiary care PICUs of the Collaborative Pediatric Critical Care Research Network (CPCCRN). Inclusion criteria were children (aged 1-18 years) admitted between 2005 and 2009 (inclusive) for asthma who received ventilation (near-fatal) or died (fatal). Data collected included medications, ventilator strategies, concomitant therapies, demographic information, and risk variables. RESULTS Of the 261 eligible children, 33 (13%) had no previous history of asthma, 218 (84%) survived with no known complications, and 32 (12%) had complications. Eleven (4%) died, 10 of whom had experienced cardiac arrest before admission. Patients intubated outside the PICU had a shorter duration of ventilation (median, 25 hours vs 84 hours; P < .001). African-Americans were disproportionately represented among the intubated children and had a shorter duration of intubation. Barotrauma occurred in 15 children (6%) before admission. Pharmacologic therapy was highly variable, with similar outcomes. CONCLUSION Of the children ventilated in the CPCCRN PICUs, 96% survived to hospital discharge. Most of the children who died experienced cardiac arrest before admission. Intubation outside the PICU was correlated with shorter duration of ventilation. Complications of barotrauma and neuromyopathy were uncommon. Practice patterns varied widely among the CPCCRN sites.

Executing medical logic modules expressed in ArdenML using Drools

The Arden Syntax is an HL7 standard language for representing medical knowledge as logic statements. Despite nearly 2 decades of availability, Arden Syntax has not been widely used. This has been attributed to the lack of a generally available compiler to implement the logic, to Ardens complex syntax, to the challenges of mapping local data to data references in the Medical Logic Modules (MLMs), or, more globally, to the general absence of decision support in healthcare computing. An XML representation (ArdenML) may partially address the technical challenges. MLMs created in ArdenML can be converted into executable files using standard transforms written in the Extensible Stylesheet Language Transformation (XSLT) language. As an example, we have demonstrated an approach to executing MLMs written in ArdenML using the Drools business rule management system. Extensions to ArdenML make it possible to generate a user interface through which an MLM developer can test for logical errors.

Clinical equipoise regarding glycemic control: a survey of pediatric intensivist perceptions.

Objectives: To assess the willingness of pediatric intensivists to conduct a pediatric trial of blood glucose control, and to determine if self-reported practices were influenced by adult-specific data over the past 4 yrs. This was a follow-up to our previous 2005 survey. Design: Electronic survey comprising a 30-item questionnaire. Setting: North American PICUs that were members of, or connected to, the Pediatric Acute Lung Injury and Sepsis Network (n = 96 targeted institutions). Participants: North American pediatric intensivists (n = 209). Interventions: None. Methods: We conducted a survey of North American PICUs using a Web-based questionnaire. Invitations were sent to 96 institutions in 37 states/provinces. Results: Response rate was 68% (141/209). The median definitions of hyperglycemia (150 mg/dL) and hypoglycemia (⩽60 mg/dL) were similar to our 2005 survey results. Self-reported practice patterns remain variable. Although 75% of clinician respondents denied a change in clinical practice based on the published literature, the preferred blood glucose target range increased from 80–110 mg/dL in 2005 to 90–140 mg/dL in 2009. Intensivists who preferred a blood glucose target of 80–110 mg/dL decreased from 43% to 6% (p < 0.001). Many respondents (45%) indicated that the acceptable severe hypoglycemia rate (% patients) for a protocol was ⩽2.5%. The majority (93%) indicated they would be willing to enroll patients in a pediatric trial of blood glucose control. Conclusions: Pediatric intensivists report that they control blood glucose with insulin in critically ill children and do not necessarily adopt adult-specific data or a single uniform blood glucose target. The published evidence does not adequately address PICU clinicians concerns. Unanswered questions and persistent variation in practice suggest a need for a multicenter clinical trial of blood glucose control in critically ill children.

The evolution of eProtocols that enable reproducible clinical research and care methods

Unnecessary variation in clinical care and clinical research reduces our ability to determine what healthcare interventions are effective. Reducing this unnecessary variation could lead to further healthcare quality improvement and more effective clinical research. We have developed and used electronic decision support tools (eProtocols) to reduce unnecessary variation. Our eProtocols have progressed from a locally developed mainframe computer application in one clinical site (LDS Hospital) to web-based applications available in multiple languages and used internationally. We use eProtocol-insulin as an example to illustrate this evolution. We initially developed eProtocol-insulin as a local quality improvement effort to manage stress hyperglycemia in the adult intensive care unit (ICU). We extended eProtocol-insulin use to translate our quality improvement results into usual clinical care at Intermountain Healthcare ICUs. We exported eProtocol-insulin to support research in other US and international institutions, and extended our work to the pediatric ICU. We iteratively refined eProtocol-insulin throughout these transitions, and incorporated new knowledge about managing stress hyperglycemia in the ICU. Based on our experience in the development and clinical use of eProtocols, we outline remaining challenges to eProtocol development, widespread distribution and use, and suggest a process for eProtocol development. Technical and regulatory issues, as well as standardization of protocol development, validation and maintenance, need to be addressed. Resolution of these issues should facilitate general use of eProtocols to improve patient care.

An Electronic Protocol for Translation of Research Results to Clinical Practice: A Preliminary Report

Introduction: We evaluated the feasibility of using an electronic protocol developed for research use (Research-eProtocol-insulin) for blood glucose management in usual intensive care unit clinical practice. Methods: We implemented the rules of Research-eProtocol-insulin in the electronic medical record of the Intermountain Healthcare hospital system (Clinical-eProtocol-insulin) for use in usual clinical practice. We evaluated the performance of Clinical-eProtocol-insulin rules in the intensive care units of seven Intermountain Healthcare hospitals and compared this performance with the performance of Research-eProtocol-insulin at the LDS Hospital Shock/Trauma/Respiratory Intensive Care Unit. Results: Clinician (nurse or physician) compliance with computerized protocol recommendations was 95% (of 21,325 recommendations) with Research-eProtocol-insulin and 92% (of 109,458 recommendations) with Clinical-eProtocol-insulin. The blood glucose distribution in clinical practice (Clinical-eProtocol-insulin) was similar to the research use distribution (Research-eProtocol-insulin); however, the mean values (119 mg/dl vs 113 mg/dl) were statistically different (P = 0.0001). Hypoglycemia rates in the research and practice settings did not differ: the percentage of measurements ≤40 mg/dl (0.11% vs 0.1%, P = 0.65) and the percentage of patients with at least one blood glucose ≤40 mg/dl (4.2% vs 3%, P = 0.23) were not statistically significantly different. Conclusion: Our electronic blood glucose protocol enabled translation of a research decision-support tool (Research-eProtocol-insulin) to usual clinical practice (Clinical-eProtocol-insulin).

A frame-based representation for a bedside ventilator weaning protocol

We describe the use of a frame-based knowledge representation to construct an adequately-explicit bedside clinical decision support application for ventilator weaning. The application consists of a data entry form, a knowledge base, an inference engine, and a patient database. The knowledge base contains database queries, a data dictionary, and decision frames. A frame consists of a title, a list of findings necessary to make a decision or carry out an action, and a logic or mathematical statement to determine its output. Frames for knowledge representation are advantageous because they can be created, visualized, and conceptualized as self-contained entities that correspond to accepted medical constructs. They facilitate knowledge engineering and provide understandable explanations of protocol outputs for clinicians. Our frames are elements of a hierarchical decision process. In addition to running diagnostic and therapeutic logic, frames can run database queries, make changes to the user interface, and modify computer variables.

Quality of reporting randomized controlled trials in cancer nursing research.

Background:Results of randomized controlled trials (RCTs) provide high-level evidence for evidence-based practice (EBP). The quality of RCTs has a substantial influence on providing reliable knowledge for EBP. Little is known about the quality of RCT reporting in cancer nursing. Objective:The aim of this study was to assess the quality of reporting in published cancer nursing RCTs from 1984 to 2010. Methods:A total of 227 RCTs in cancer nursing published in English-language journals and indexed in PubMed or Cumulative Index to Nursing and Allied Health Literature were reviewed using the Jadad scale, key methodologic index (KMI), and the Consolidated Standards of Reporting Trials (CONSORT) checklist to assess the quality of reporting methodological aspects of research and the overall quality of reporting RCTs. Results:Adherence to reporting metrics was relatively low, based on the Jadad score (M = 1.94 out of 5, SD = 1.01), KMI scores (M = 0.84 out of 3, SD = .87), and adherence to CONSORT checklist items (M =16.92 out of 37, SD = 4.03). Only 11 of 37 items in the CONSORT checklist were reported in 80% or more of the studies reviewed. The quality of reporting showed some improvement over time. Discussion:Adherence to reporting metrics for cancer nursing RCTs was suboptimal, and further efforts are needed to improve both methodology reporting and overall reporting. Journals are encouraged to adopt the CONSORT checklist to influence the quality of RCT reports.