Ventricular assist device using a thoracotomy-based implant technique: Multi-Center Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy (HM3 SWIFT).

OBJECTIVES: The HeartMate 3 (Abbott) left ventricular assist device provides substantial improvement in long-term morbidity and mortality in patients with advanced heart failure. The Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study compares thoracotomy-based implantation clinical outcomes with standard median sternotomy. METHODS: We conducted a prospective, multicenter, single-arm study in patients eligible for HeartMate 3 implantation with thoracotomy-based surgical technique (bilateral thoracotomy or partial upper sternotomy with left thoracotomy). The composite primary end point was survival free of disabling stroke (modified Rankin score >3), or reoperation to remove or replace a malfunctioning device, or conversion to median sternotomy at 6-months postimplant (elective transplants were treated as a success). The primary end point (noninferiority, -15% margin) was assessed with >90% power compared with a propensity score-matched cohort (ratio 1:2) derived from the Multi-Center Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 continued access protocol. RESULTS: The study enrolled 102 patients between December 2020 and July 2022 in the thoracotomy-based arm at 23 North American centers. Follow-up concluded in December 2022. In the Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study group, noninferiority criteria was met (absolute between-group difference, -1.2%; Farrington Manning lower 1-sided 95% CI, -9.3%; P < .0025) and event-free survival was not different (85.0% vs 86.2%; hazard ratio, 1.01; 95% CI, 0.58-2.10). Length of stay with thoracotomy-based implant was longer (median, 20 vs 17 days; P = .03). No differences were observed for blood product utilization, adverse events (including right heart failure), functional status, and quality of life between cohorts. CONCLUSIONS: Thoracotomy-based implantation of the HeartMate 3 left ventricular assist device is noninferior to implantation via standard full sternotomy. This study supports thoracotomy-based implantation as an additional standard for surgical implantation of the HeartMate 3 left ventricular assist device.

Characterizing the pain score trajectories of hospitalized adult medical and surgical patients: a retrospective cohort study.

Pain care for hospitalized patients is often suboptimal. Representing pain scores as a graphical trajectory may provide insights into the understanding and treatment of pain. We describe a 1-year, retrospective, observational study to characterize pain trajectories of hospitalized adults during the first 48 hours after admission at an urban academic medical center. Using a subgroup of patients who presented with significant pain (pain score >4; n = 7762 encounters), we characterized pain trajectories and measured area under the curve, slope of the trajectory for the first 2 hours after admission, and pain intensity at plateau. We used mixed-effects regression to assess the association between pain score and sociodemographics (age, race, and gender), pain medication orders (opioids, nonopioids, and no medications), and medical service (obstetrics, psychiatry, surgery, sickle cell, intensive care unit, and medicine). K-means clustering was used to identify patient subgroups with similar trajectories. Trajectories showed differences based on race, gender, service, and initial pain score. Patients presumed to have dissimilar pain experiences (eg, sickle vs obstetrical) had markedly different pain trajectories. Patients with higher initial pain had a more rapid reduction during their first 2 hours of treatment. Pain reduction achieved in the 48 hours after admission was approximately 50% of the initial pain, regardless of the initial pain. Most patients' pain failed to fully resolve, plateauing at a pain score of 4 or greater. Visualizing pain scores as graphical trajectories illustrates the dynamic variability in pain, highlighting pain responses over a period of observation, and may yield new insights for quality improvement and research.

An exploratory analysis of the correlation of pain scores, patient satisfaction with relief from pain, and a new measure of pain control on the total dose of opioids in pain care.

OBJECTIVE: We explored the associations between opioid dose and multiple measures of pain. STUDY DESIGN AND MEASURES: Thirty-two consecutive patients admitted solely for an acute exacerbation of cancer-related pain or for surgery were followed for their entire hospital stay (115 days of pain). For each hospital day, we collected pain scores, the number of pain scores, trends in pain scores, the percentage of time patients had 100% acceptable relief from pain, and the number of times patients were asked about acceptable pain relief. Finally, we asked those who had 100% relief of pain whether they could have used more pain medicine. Linear regression models were fit to estimate the amount of variation explained (R) in dose of medication, by each pain measurement variable. RESULTS: Nineteen patients with cancer (74 days of pain) and 13 patients undergoing surgery (41 days of pain) were evaluated. Pain scores, the number of pain scores, trends in pain scores, and 100% acceptable relief scores poorly correlated with the use of medication in the linear regression models (R for all models ≤0.2). A question about needing more pain medicine explained the greatest amount of variation in opioid dose. CONCLUSIONS: Pain and acceptable relief scores do not adequately reflect the use of medication. A prospective study is needed to further assess the value of additional measures of the adequacy of pain care.

Diagnostic error in medicine: analysis of 583 physician-reported errors.

BACKGROUND: Missed or delayed diagnoses are a common but understudied area in patient safety research. To better understand the types, causes, and prevention of such errors, we surveyed clinicians to solicit perceived cases of missed and delayed diagnoses. METHODS: A 6-item written survey was administered at 20 grand rounds presentations across the United States and by mail at 2 collaborating institutions. Respondents were asked to report 3 cases of diagnostic errors and to describe their perceived causes, seriousness, and frequency. RESULTS: A total of 669 cases were reported by 310 clinicians from 22 institutions. After cases without diagnostic errors or lacking sufficient details were excluded, 583 remained. Of these, 162 errors (28%) were rated as major, 241 (41%) as moderate, and 180 (31%) as minor or insignificant. The most common missed or delayed diagnoses were pulmonary embolism (26 cases [4.5% of total]), drug reactions or overdose (26 cases [4.5%]), lung cancer (23 cases [3.9%]), colorectal cancer (19 cases [3.3%]), acute coronary syndrome (18 cases [3.1%]), breast cancer (18 cases [3.1%]), and stroke (15 cases [2.6%]). Errors occurred most frequently in the testing phase (failure to order, report, and follow-up laboratory results) (44%), followed by clinician assessment errors (failure to consider and overweighing competing diagnosis) (32%), history taking (10%), physical examination (10%), and referral or consultation errors and delays (3%). CONCLUSIONS: Physicians readily recalled multiple cases of diagnostic errors and were willing to share their experiences. Using a new taxonomy tool and aggregating cases by diagnosis and error type revealed patterns of diagnostic failures that suggested areas for improvement. Systematic solicitation and analysis of such errors can identify potential preventive strategies.

Computer-based simulation as a teaching tool for residents treating patients with cancer-related pain crises.

CONTEXT: Residents often fail to escalate narcotics to ensure pain relief in patients with cancer because of fear of overdose. A computer simulation of patients in pain may provide a way to improve management without fear of harm. We developed a pain care simulation to train residents. STUDY DESIGN/MEASURES: Thirty-one residents trained on 2 to 3 consecutive simulated patients. Simulated cases were assigned variable tolerances to narcotics and starting pain scores. The goals of training were as follows: (1) rapid induction of pain relief, (2) measurement of pain response at appropriate times, and (3) early institution and escalation in care long-acting pain medication to ensure stable pain control for 48 hours. Seven reviewers judged graphical summaries of care and assessed if pain improved, worsened, or stayed the same. RESULTS: Thirty-one residents participated: 25 completed 3 simulations; 6 completed only 2. Sixty-eight percent improved from case 1 to 2; 90% improved by 3. The average pain score declined from 2.5 in case 1 to 1.9 in case 3 (P = .04). Rescue medication use declined from 37% for the first case to 23% by the third (P = .18). Reviewers' intraclass correlation for improved pain care was 0.821 (95% CI, 0.721-0.895). CONCLUSIONS: Residents improved using a pain treatment simulator. A graphical representation of pain scores more than 48 hours of care that provides a useful way to assess pain control. Lessons learned may translate into improved patient care.

Effects of training on a simulator of pain care on the quality of pain care for patients with cancer-related pain.

CONTEXT: A computer simulator of pain care provided an environment for residents to learn to (1) rapidly induce pain relief; (2) measure pain scores at appropriate time intervals; (3) use induction doses to estimate, early in care, the long-acting pain medication requirements; and (4) escalate long-acting agents to ensure a smooth and nonvarying pain-control curve. We studied whether lessons learned on the simulator translated into improved pain control for patients with cancer-related pain crises. STUDY DESIGN AND MEASURES: We compared pain scores for 48 hours in 2 groups: 20 patients admitted consecutively, solely because of an acute exacerbation of pain, prior to training our residents on a simulator and 20 patients post-training. Training at the beginning of an oncology rotation consisted of education about pain control followed by practice on simulated cases of patients with cancer-related pain crises. Outcome measures were average pain scores compared using linear regression and the frequency of using long-acting agents early in a patient's care. RESULTS: Pain control in the first 48 hours of care improved in the postintervention period; the slope of the pain scores actually increased in the preintervention period and declined in the postintervention period (P < .0005). Residents used long-acting agents early in patients' care in 35% (7/20) in the preperiod and 90% (18/20) in the postperiod (P < .001). CONCLUSIONS: Residents developed pain care treatment skills on a computer-based simulator that translated into improved control of acute, cancer-related pain.

Introduction to thoracic endografting: imaging, guidewires, guiding catheters, and delivery sheaths.

PURPOSE: With the recent approval of the first thoracic endoprosthesis in the United States for the treatment of isolated descending thoracic aortic aneurysms, there has been a dramatic increase in the number of physicians interested in getting involved in this emerging technology. However, many of these physicians do not have extensive endovascular experience, are not familiar with the catheters and guidewires used for thoracic endografting procedures, or do not have access to a full complement of endovascular resources. DESCRIPTION: We discuss the basics of catheters, guidewires, and balloons necessary to perform thoracic endovascular procedures. EVALUATION: Adequate radiographic visualization of the thoracic aorta and access vessels is essential for all phases of the thoracic endografting procedure. In addition, a vast array of catheters, guidewires, balloons, and sheaths have been designed to assist with endovascular access and delivery of various therapeutic modalities. CONCLUSIONS: Each of the different catheters and guidewires serve an important purpose in the conduct of thoracic endografting procedures, and it is important to have a full understanding of these devices to ensure the best results.

Organizational and cultural changes for providing safe patient care.

OBJECTIVE: To describe an approach and experience with fostering a culture of patient safety. METHODS: (1) Organizational Change-The Department of Medicine established a patient safety committee (PSC) and charged it with reviewing adverse events. (2) Cultural Change-PSC sponsors and participants work to promote a culture of collaboration, study, learning, and prevention versus a culture of blame. (3) Collaboration-The PSC includes chief residents and members from medical informatics, nursing, pharmacy, quality assurance, risk management, and utilization management. (4) Evolution-The duties of the PSC progressed from merely learning from adverse event reports to implementing patient safety and quality improvement projects. (5) Standardization-The PSC uses standard definitions and procedures when reviewing cases of adverse events, and when conducting patient safety and quality improvement projects. RESULTS: (1) Developed an online adverse event reporting system, shortening the average report collection time by 2 days and increasing the number of adverse events reported. (2) Established a model for change using (a) safety rounds with residents, (b) e-mail safety alerts, and, in some cases, (c) decision alerts using electronic order entry. These changes in culture and capability led to improvements in care and improved financial results. CONCLUSIONS: Senior management support of a culture of learning and prevention and an organizational structure that promotes collaboration has provided an environment in which patient safety initiatives can flourish by providing not only safer and higher quality patient care but also a positive financial return on investment.

Mailings timed to patients' appointments: a controlled trial of fecal occult blood test cards.

BACKGROUND: Fecal occult blood testing (FOBT) programs cost-effectively reduce colon cancer mortality. To improve the rate of colon cancer screening with FOBT, we tested the effect of mailing FOBT cards timed to appointments on the rates of completion of FOBT. DESIGN: Controlled trial. SETTING/PARTICIPANTS: A total of 119 patients with primary care appointments scheduled in May or June 2000 for an urban, public hospital clinic that serves predominantly low-income, African Americans with chronic diseases. The patients in the study were selected by linking a quality improvement registry, the appointment system database, and an FOBT database to generate a list of clinic patients who had not completed an FOBT in the preceding year. INTERVENTION: Subjects were assigned to either a system of mailing FOBT cards and reminders 2 weeks prior to a scheduled appointment or usual care. MAIN OUTCOME MEASURES: The primary outcomes were the rate of screening at the index appointment and during the year beginning with the date of the index appointment. RESULTS: The rate of return of the FOBT cards during the year beginning with the index appointment was 40.7% for the intervention group compared to 5% for the usual care group (odds ratio [OR]=13.0, p <0.001). The difference was accounted for largely by increases in screening at the index appointment (35.6% compared to 3.3%, OR=16.0, p <0.001). CONCLUSIONS: Using computer databases to generate a list of patients due for FOBT and then mailing FOBT cards timed to a scheduled appointment significantly increased the rate of colon cancer screening. This may be an efficient approach to increasing colon cancer screening with FOBT.

A model of medical error based on a model of disease: interactions between adverse events, failures, and their errors.

This article discusses Rush-Presbyterian-St. Luke's Medical Center's approach to assessing and preventing errors in care and promoting patient safety. The word error is applied to all kinds of events, including adverse occurrences, negligence, and malpractice. Thus confusion exists among those analyzing the causes of adverse events. A patient safety committee standardized the definition of medical error and developed a taxonomy for error as a prelude to efforts at error reduction. It identified three levels or layers that can represent a train of events culminating in an undesired outcome: error, treatment failure, and adverse event. This discussion is offered in the interest of clarifying some of the issues.