The results of this study illustrate that prospective use of the CUSUM method can alert surgeons to suboptimal results and the need for prompt remedial action in advance of standard comparative analyses.

In a highly innovative field such as cardiac surgery where techniques are changing weekly, an online sequential probability assessment of patient outcomes is obligatory. The researchers have already noted significant interest of CUSUM analysis in the cardiac surgical community in North America and Europe and believe that it will have a significant impact on future outcome assessment in cardiac surgery.

Photo: Richard J. Novick, MD, the Principal Investigator of the study.

Publications
Novick RJ, Fox SA, Stitt LW, Swinamer SA, Lehnhardt KR, Rayman R, Boyd DW. Cumulative sum failure analysis of a policy change from on pump to off pump coronary artery bypass grafting. Ann Thorac Surg 2001;72:S1016-21.
Novick RJ, Fox SA, Stitt LW, Kiaii BB, Swinamer SA, Rayman R, Wenske TR, Boyd WD. Assessing the learning curve in off-pump coronary artery surgery via CUSUM failure analysis. Ann Thorac Surg 2002;73:S358-62.
Novick RJ, Fox SA, Stitt LW, Kiaii BB, Abu-Khudair W, Lee A, Benmusa A, Swinammer SA, Rayman R, Menkis AM, McKenzie FN, Quantz MA, Boyd WD. Effect of off pump coronary artery bypass grafting on risk-adjusted and cumulative sum failure outcomes after coronary artery surgery. J Card Surg (in press).

Presentations
Cumulative Sum Failure Learning Curve Analysis of a Policy Change from On Pump to Off Pump Coronary Artery Bypass Grafting. Society of Thoracic Surgeons meeting, New Orleans, January 27, 2001.
Assessing The Learning Curve In Off Pump Coronary Artery Surgery Via Cusum Failure Analysis. Key West Outcomes 2001 meeting, Key West, Florida, May 26, 2001.
Assessing the Learning Curve of Innovative Cardiac Surgical Procedures. First International Symposium on Cardiovascular Science: From Bench to Bedside. Hong Kong, November 24, 2001.
Use of Cumulative Sum Failure Analysis to Assess the Learning Curve of Innovative Cardiac Surgical Procedures, Peak Performance XV meeting, Lake Louise, Alberta, March 3, 2002.
Numerous additional presentations locally (Cardiology and Cardiac Surgery rounds, teaching sessions).

Pediatric Sedation: a Safety and Efficacy Problem for Children Requiring Diagnostic and Therapeutic Procedures in the Hospital Setting; A Human Factors Opportunity for Improvement
Investigators: George T. Blike, MD (PI), Joseph Cravero, MD, Gene Nelson, PhD, Kate Whalen, RN
The goal of this project was to develop safer and more effective pediatric sedation strategies that would generalize to other practice settings. Human factors study methods were used to characterize pediatric sedation in the hospital setting and define minimally acceptable outcomes for pediatric sedation work. Tools were created to measure the sedation work process and video recordings were used to perform a field study. A pediatric work sedation system was modeled and tested in a full scope pediatric simulator.

This work broadly dealt with the clinical reality of trading off efficacy and safety. In this case, the harm from a child experiencing the pain of the procedure vs. the child suffering brain damage or death for the sedation used to mitigate the pain. Weighing the risks and benefits of medical therapy is germane to all medical care. The major qualitative finding of this study is that uncoupling the resources (crew) that manage the therapy, from the resources (crew) that manages the side effects of the therapy, has significant impact on safety.

This study has fundamentally changed how medical practitioners traditionally view the concepts of drug efficacy, drug toxicity and therapeutic index and widened this view to encompass practitioner expertise, medical technology, environmental factors and patient demands. Most importantly, this research resulted in providing more effective and safer sedation for children who require painful, stressful procedures to receive.

Publications: Journal Articles
Blike GT, Cravero JP, Nelson G: "Same Patient, Same Critical Events Different system of care, Different Outcomes: Description of a Human Factors Approach Aimed at Improving the Efficacy and Safety of Sedation/Analgesia Care" Quality Management in Health Care Winter 2001 (Issue Editor: Jean Gayton Carroll; Publisher: Aspen Publishers, Inc.) (in press).
Blike GT, Cravero JP, Sowb Y, Lancaster JC: "A Semi Quantitative Method for Evaluating the Efficacy and Safety of Pediatric Sedation Services." Revision submitted to Journal of Pediatrics, 2001.

Publications: Abstracts (published in proceedings)
Blike GT, Cravero JP, Lancaster JC: "A Descriptive Model of Pediatric Procedural Work Based on Human Factors Analysis" Presented at the Society for Technology in Anesthesiology Annual Meeting, Orlando, Florida, January 2000.
Blike GT, Cravero JP: "A Model of Pediatric Procedural Sedation Care" Presented at the Association of University Anesthesiologists Annual Meeting, Salt Lake City, Utah; May 2000.
Cravero JP, Blike GT, Lancaster JC: "A Novel Approach to Evaluating Efficacy and Safety of Pediatric Sedation Services" Submitted at the Society for Pediatric Anesthesia Annual Meeting, Sanabel Island, Florida, February 2000.
Blike GT, Cravero JP, Lancaster JC: "A Novel Approach to Evaluating Efficacy and Safety of Pediatric Sedation Services" Presented at the International Anesthesia Research Society National Meeting, Hawaii, March 2000.
Cravero JP, Blike GT, Whalen K, King K, Jensen J: A new Approach to Evaluating the Efficacy of Pediatric Sedation. ASA National Meeting, San Francisco, CA 2000.
Cravero JP, Blike GT, Rohan C, King K, Strauss C: "Factors that Influence Patient and Parental Satisfaction with Pediatric Sedation Activity" Presented at the Society for Pediatric Anesthesia Annual Meeting, San Diego, CA, February 2001.
Cravero JP, Blike GT, Rohan C, King K, Strauss C: "Factors that Influence Patient and Parental Satisfaction with Pediatric Sedation Activity" Submission at the American Society of Anesthesiologists Annual Meeting, New Orleans, LA, October 2001.

Publications: Web based publications
Blike GT, Cravero JP; "Pride Prejudice and Pediatric Sedation-Report from a Multispecialty Summit" National Patient Safety Foundation will be publishing, (accepted)
A Web site has been created to disseminate Pediatric Sedation Safety research activities. Literature reviews are being posted.
A monthly newsletter starting in November now has a readership of over 1,700.

Presentations: Regional
2001: "Perioperative Improvement Updates - PACU bypass and Pediatric procedural sedation," Joseph Cravero and George Blike, Department of Anesthesiology, Grand Rounds, DHMC, Lebanon, NH.
2000: "Understanding Medical Errors," Keynote Speaker for Medical Errors Workshop for departments of GIM, Family Medicine and Pediatrics, DHMC, Lebanon, NH.

Presentations: National
2001: "Building a Culture of Safety: The Problem and Some Solutions," Institute for Healthcare Improvement Breakthrough Series, San Antonio, TX.
2001: "Using a Pediatric Simulator to Probe Sedation Systems," Workshop session at the Society for Technology in Anesthesia Annual Meeting, Scottsdale, AZ.
2000: "New Methods for Evaluating the Safety and Efficacy of Pediatric Sedation Work." Partnership for patient safety (P4PS) sponsored by Volunteer Hospital Association. Dallas ,TX.
2000: "Improving Safety in High Hazard Areas," Institute for Healthcare Improvement Breakthrough Series, Pittsburgh, PA.
2000: "Roundtable discussion on Pediatric Sedation," Dartmouth Summit on Pediatric Sedation, Lebanon, NH.
2000: "Issues in Pediatric Anesthesiology." Anesthesiology Grand Rounds, Boston Childrens Hospital, Boston, MA.
2000: "New Methods for Analyzing Safety and Efficacy in Pediatric Patients." CHaD Current Conference, Manchester, NH

Photo: Project investigators Drs. George Blike and Joseph Cravero

Understanding and Improving Error Detection and Recovery in Simulated Acute Care Settings: Fixation vs. Adaptability
Boston College, Chestnut Hill, MA
Investigators: William R. Torbert, PhD, Jenny Rudolph, PhD, John S. Carroll, PhD, Daniel Ramer, PhD
The goal of this project was to help medical trainees understand and transcend their internal barriers in identifying, discussing, and recovering from error. The study focused on the debriefing of trainees who have been challenged with responding to critical events during training sessions in a realistic simulator. Study aim was to better understand the process of fixation error, revise the debriefing sessions to reduce fixation and improve hypothesis generation, and then retest performance in a subsequent event to assess the efficacy of the intervention.

Serious Medication Errors: Evaluation of Prevention Strategies in Pediatrics
Children's Hospital, Boston, MA
Investigators: Donald Goldmann, MD, Rainu Kaushal, MD, David W. Bates, MD, Margaret D. Clapp, MS
The team of this project is studying the effectiveness of two interventions, pharmacist involvement on inpatient pediatric wards plus CQI teams and a physician order system, on the rate of serious medication errors at two academic pediatric institutions. This project follows a study that has been examining adverse events and medications errors in a fashion similar to that of studies in adult populations. While these interventions have been studied in adult populations, the investigators have identified unique qualities of errors and sequelae in children that justify examination in this setting.