OCT-Guided versus Angiography-Guided Coronary Stent Implantation in Complex Lesions: An ILUMIEN IV Substudy.

BACKGROUND: ILUMIEN IV was the first large-scale, multicenter, randomized trial comparing optical coherence tomography (OCT)-guided versus angiography-guided stent implantation in patients with high-risk clinical characteristics and/or complex angiographic lesions. OBJECTIVE: Here, we aimed to specifically examine outcomes in the complex angiographic lesions subgroup. METHODS: From the original trial population (n=2487), high-risk patients without complex angiographic lesions were excluded (n=514). Complex angiographic lesion characteristics included 1) long or multiple lesions with intended total stent length ≥28 mm; 2) bifurcation lesion with intended two-stent strategy; 3) severely calcified lesion; 4) chronic total occlusion; or 5) in-stent restenosis. The study endpoints were 1) final minimal stent area (MSA); 2) 2-year composite of serious major adverse cardiovascular events (MACE; cardiac death, target-vessel myocardial infarction (MI), or stent thrombosis); and 3) 2-year effectiveness, defined as target-vessel failure (TVF), a composite of cardiac death, target-vessel MI, or ischemia-driven target-vessel revascularization. RESULTS: The post-PCI MSA was larger in the OCT- (n=992) versus angiography-guided (n=981) group (5.56±1.95 versus 5.26±1.81mm2; difference, 0.30; 95% confidence interval [CI], 0.14-0.47; P<0.001). Compared with angiography-guided PCI, OCT-guided PCI resulted in a lower risk of serious MACE (3.1% versus 4.9%; hazard ratio [HR], 0.63; 95% CI, 0.40-0.99; P=0.04). TVF was not significantly different between groups (7.3% versus 8.8%; HR, 0.82; 95% CI, 0.59-1.12; P=0.20). CONCLUSIONS: In complex angiographic lesions, OCT-guided PCI led to a larger MSA and reduced the serious MACE composite of cardiac death, target-vessel MI, or stent thrombosis compared with angiography-guided PCI at 2 years, but did not significantly improve TVF.

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.

Optical Coherence Tomography-Guided versus Angiography-Guided PCI.

BACKGROUND: Data regarding clinical outcomes after optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) as compared with angiography-guided PCI are limited. METHODS: In this prospective, randomized, single-blind trial, we randomly assigned patients with medication-treated diabetes or complex coronary-artery lesions to undergo OCT-guided PCI or angiography-guided PCI. A final blinded OCT procedure was performed in patients in the angiography group. The two primary efficacy end points were the minimum stent area after PCI as assessed with OCT and target-vessel failure at 2 years, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization. Safety was also assessed. RESULTS: The trial was conducted at 80 sites in 18 countries. A total of 2487 patients underwent randomization: 1233 patients were assigned to undergo OCT-guided PCI, and 1254 to undergo angiography-guided PCI. The minimum stent area after PCI was 5.72±2.04 mm2 in the OCT group and 5.36±1.87 mm2 in the angiography group (mean difference, 0.36 mm2; 95% confidence interval [CI], 0.21 to 0.51; P<0.001). Target-vessel failure within 2 years occurred in 88 patients in the OCT group and in 99 patients in the angiography group (Kaplan-Meier estimates, 7.4% and 8.2%, respectively; hazard ratio, 0.90; 95% CI, 0.67 to 1.19; P = 0.45). OCT-related adverse events occurred in 1 patient in the OCT group and in 2 patients in the angiography group. Stent thrombosis within 2 years occurred in 6 patients (0.5%) in the OCT group and in 17 patients (1.4%) in the angiography group. CONCLUSIONS: Among patients undergoing PCI, OCT guidance resulted in a larger minimum stent area than angiography guidance, but there was no apparent between-group difference in the percentage of patients with target-vessel failure at 2 years. (Funded by Abbott; ILUMIEN IV: OPTIMAL PCI ClinicalTrials.gov number, NCT03507777.).

Learning optimal opioid prescribing and monitoring: a simulation study of medical residents.

OBJECTIVE: Hospitalized patients often receive opioids. There is a lack of consensus regarding evidence-based guidelines or training programs for effective management of pain in the hospital. We investigated the viability of using an Internet-based opioid dosing simulator to teach residents appropriate use of opioids to treat and manage acute pain. MATERIALS AND METHODS: We used a prospective, longitudinal design to evaluate the effects of simulator training. In face-to-face didactic sessions, we taught 120 (108 internal medicine and 12 family medicine) residents principles of pain management and how to use the simulator. Each trainee completed 10 training and, subsequently, 5 testing trials on the simulator. For each trial, we collected medications, doses, routes and times of administration, pain scores, and a summary score. We used mixed-effects regression models to assess the impact of simulation training on simulation performance scores, variability in pain score trajectories, appropriate use of short- and long-acting opioids, and use of naloxone. RESULTS: Trainees completed 1582 simulation trials (M = 13.2, SD = 6.8), with sustained improvements in their simulated pain management practices. Over time, trainees improved their overall simulated pain management scores (b = 0.05, P < .01), generated lower pain score trajectories with less variability (b = -0.02, P < .01), switched more rapidly from short-acting to long-acting agents (b = -0.50, P < .01), and used naloxone less often (b = -0.10, P < .01). DISCUSSION AND CONCLUSIONS: Trainees translated their understanding of didactically presented principles of pain management to their performance on simulated patient cases. Simulation-based training presents an opportunity for improving opioid-based inpatient acute pain management.

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.

Association of the position of a hospital-acquired condition diagnosis code with changes in medicare severity diagnosis-related group assignment.

CONTEXT: Incentives to improve quality include paying less for adverse events, including the Centers for Medicare and Medicaid Services' policy to not pay additionally for events classified as hospital-acquired conditions (HACs). This policy is controversial, as variable coding practices at hospitals may lead to differences in the inclusion and position of HACs in the list of codes used for Medicare Severity Diagnosis-Related Group (MS-DRG) assignment. OBJECTIVE: Evaluate changes in MS-DRG assignment for patients with an HAC and test the association of the position of an HAC in the list of International Classification of Diseases, 9th Revision (ICD-9) diagnosis codes with change in MS-DRG assignment. DESIGN AND SETTING: Retrospective analysis of patients discharged from hospital members of the University HealthSystem Consortium's Clinical Data Base between October 2007 and April 2008. Comparisons were made between the MS-DRG assigned when the HAC was not included in the list of ICD-9 diagnosis codes and the MS-DRG that would have been assigned had the HAC code been included in the assignment. RESULTS: Of the 7027 patients with an HAC, 13.8% changed MS-DRG assignment when the HAC was removed. An HAC in the second position versus third position or lower was associated with a 40-fold increase in the likelihood of MS-DRG change. CONCLUSIONS: The position of an HAC in the list of diagnosis codes, rather than the presence of an HAC, is associated with a change in MS-DRG assignment. HACs have little effect on reimbursement unless the HAC is in the second position and patients have minor severity of illness.

Effects of explicit teacher-implemented phoneme awareness instruction in 4-year-olds.

The purpose of this study was to determine whether gains would be observed in an integrated group of 4-year-olds when phoneme awareness skills were explicitly taught by trained early childhood educators. In a quasi-experimental design with a delayed treatment approach, one classroom (N = 14) was randomly assigned to receive the instructional program in fall, while a second classroom (N = 10) served as a control and subsequently received the program in spring. Baseline assessment of speech and language skills indicated there were four participants with speech and/or language impairments. The teacher training involved an initial workshop and weekly hour-long mentoring meetings; the program was provided for 20 min a day, 4 d a week, for 10 weeks. Outcome measures of phoneme awareness and letter knowledge skills were obtained from non-standardized tasks administered pre-instruction and post-instruction, at mid-year and end-year points. When each classroom received the phoneme instruction, participants made gains in letter knowledge and phoneme level skills in comparison with group performance under regular instruction. These gains were statistically significant for phoneme blending and letter knowledge. Using an aggregate of all outcome measures, the gain for each classroom when under instruction was statistically significant as compared with when that same classroom was receiving the regular curriculum. Children with speech and/or language impairment responded more variably. Gains in the more difficult phoneme awareness skill of blending suggest the potential for marked change with an intensive, explicit classroom instruction and hold promise for SLPs collaborating with preschool teachers to provide time-efficient PA instruction.

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.

Cost and quality implications of discrepancies between admitting and discharge diagnoses.

BACKGROUND: Presenting and discharge diagnoses of hospitalized patients may differ as a result of patient complexity, diagnostic dilemmas, or errors in clinical judgment at the time of primary assessment. When diagnoses at admission and discharge are not in agreement, this discrepancy may indicate more complex processes of care and resultant costs. It is unclear whether surrogate measures reflecting quality of care are impacted by discrepant diagnoses. OBJECTIVE: To assess whether an association exists between admitting and discharge International Classification of Diseases, Ninth Revision (ICD-9) diagnosis codes and other quality markers including hospital length of stay, total cost of care, and 30-day readmission rate. METHODS: This was a retrospective, cross-sectional analysis of general internal medicine patients aged 18 years and older. Diagnosis discrepancy was defined as a difference between the 3-digit ICD-9 diagnosis code at admission and the principal 3-digit ICD-9 diagnosis code at discharge. RESULTS: Sixty-eight percent of patients had a diagnosis discrepancy. Diagnosis discrepancy was associated with a 0.41-day increase in length of stay (P < .001), $663 increase in direct costs (P < .001), and a 1.55 times greater odds of readmission within 30 days (P < .001). CONCLUSION: Diagnosis discrepancy was associated with hospital quality outcome measures. This finding likely reflects variations in patients' diagnostic complexity.

Hospital care may not affect the risk of readmission.

BACKGROUND: : Thirty-day readmissions have become a focal point for reducing health care spending, because they are viewed as a marker of the quality of hospital care. However, if increased time in the hospital is associated with better care, attempts to shorten length of stay (LOS) may result in increased rates of readmission. As such, we sought to explore the association of an incremental added day in LOS with the rate of readmission. METHODS: : We examined the rate of readmission at 30 and 120 days for 4151 patients admitted to a general internal medicine unit between July 2004 and March 2006. We used binary logistic regression to examine the relationship between an incremental added day in LOS and the probability of readmission. RESULTS: : Readmission rates were 8.7% at 30 days and 21.0% at 120 days, respectively. After controlling for demographic characteristics and severity of illness, we found that the probability of readmission varied little for an incremental added day in LOS. CONCLUSIONS: : Our findings suggest that more hospital care may not affect the likelihood of readmission and thus denying payment for readmission may be unwarranted.

Change in MS-DRG assignment and hospital reimbursement as a result of Centers for Medicare & Medicaid changes in payment for hospital-acquired conditions: is it coding or quality?

CONTEXT: In October 2008, the Centers for Medicare & Medicaid Services reduced payments to hospitals for a group of hospital-acquired conditions (HACs) not documented as present on admission (POA). It is unknown what proportion of Medicare severity diagnosis related group (MS-DRG) assignments will change when the International Classification of Disease, 9th Revision, Clinical Modification (ICD-9-CM) diagnosis code for the HAC is not taken into account even before considering the POA status. OBJECTIVES: The primary objectives were to estimate the proportion of cases that change MS-DRG assignment when HACs are removed from the calculation, the subsequent changes in reimbursement to hospitals, and the attenuation in changes in MS-DRG assignment after factoring in those that may be POA. Last, we explored the effect of the numbers of ICD-9-CM diagnosis codes on MS-DRG assignment. METHODS: We obtained 2 years of discharge data from academic medical centers that were members of the University Health System Consortium and identified all cases with 1 of 7 HACs coded through ICD-9-CM diagnosis codes. We calculated the MS-DRG for each case with and without the HAC and, hence, the proportion where MS-DRG assignment changed. Next, we used a bootstrap method to calculate the range in the proportion of cases changing assignment to account for POA status. Changes in reimbursement were estimated by using the 2008 MS-DRG weights payment formula. RESULTS: Of 184,932 cases with at least 1 HAC, 27.6% (n = 52,272) would experience a change in MS-DRG assignment without the HAC factored into the assignment. After taking into account those conditions that were potentially POA, 7.5% (n = 14,176) of the original cases would change MS-DRG assignment, with an average loss in reimbursement per case ranging from $1548 with a catheter-associated urinary tract infection to $7310 for a surgical site infection. These reductions would translate into a total reimbursement loss of $50 261,692 (range: $38 330,747-$62 344,360) for the 86 academic medical centers. Those cases, for all conditions, with reductions in payment also have fewer additional ICD-9-CM codes associated. CONCLUSIONS: Removing HACs from MS-DRG assignment may result in significant cost savings for the Centers for Medicare & Medicaid Services through reduced payment to hospitals. As more conditions are added, the negative impact on hospital reimbursement may become greater. However, it is possible that variation in coding practice may affect cost savings and not reflect true differences in quality of 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.

Discrepancy between admission and discharge diagnoses as a predictor of hospital length of stay.

CONTEXT: The addition of clinical data or present on admission (POA) codes to administrative databases improves the accuracy of predicting clinical outcomes, such as inpatient mortality. Other POA information may also explain variation in hospital outcomes, such as length of stay (LOS), but this potential has not been previously explored. OBJECTIVES: To assess whether a discrepancy between the diagnosis coded at the time of admission and the diagnoses coded at discharge independently explains variation in LOS for general internal medicine patients. DESIGN, SETTING, AND PATIENTS: A retrospective data review of patients age 18 years and older admitted to general internal medicine units at a large, urban academic medical center between July 2005 and June 2006. A generalized linear regression model was constructed to adjust for patient factors known to be associated with LOS. OUTCOME MEASURE: Average LOS among patients with a discrepancy between the admitting and discharge diagnosis codes versus those patients without a discrepancy. MAIN RESULTS: The average LOS for patients without a discrepancy between the admitting and discharge diagnosis codes, adjusted for comorbid conditions, was 3.4 days compared to 4.2 days with a discrepancy (0.76-day increase; P < 0.01). CONCLUSIONS: Diagnosis discrepancy is associated with longer LOS. Diagnosis discrepancy on admission may be a marker of diagnosis uncertainty or poor patient assessment/documentation. Further research is needed to understand the underlying reasons for this discrepancy and its association with LOS, and, potentially, clinical outcomes.

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.