Agile response to critical need for clinical trial accessibility during the first COVID-19 pandemic wave.

This article discusses some of the major challenges that the clinical research community faced during the early days of the coronavirus disease 2019 pandemic. A model is offered that may assist other institutions while planning for future pandemics or disasters.

Developing an Interdisciplinary, Team-Based Quality Improvement Leadership Training Program for Clinicians: The Partners Clinical Process Improvement Leadership Program.

Although there has been tremendous progress in quality improvement (QI) education for students and trainees in recent years, much less has been published regarding the training of active clinicians in QI. The Partners Clinical Process Improvement Leadership Program (CPIP) is a 6-day experiential program. Interdisciplinary teams complete a QI project framed by didactic sessions, interactive exercises, case-based problem sessions, and a final presentation. A total of 239 teams composed of 516 individuals have graduated CPIP. On completion, participant satisfaction scores average 4.52 (scale 1-5) and self-reported understanding of QI concepts improved. At 6 months after graduation, 66% of survey respondents reported sustained QI activity. Three opportunities to improve the program have been identified: (1) increasing faculty participation through online and tiered course offerings, (2) integrating the faculty-focused program with the trainee curriculum, and (3) developing a postgraduate curriculum to address the challenges of sustained improvement.

Can 360-Degree Reviews Help Surgeons? Evaluation of Multisource Feedback for Surgeons in a Multi-Institutional Quality Improvement Project.

BACKGROUND: Medical organizations have increased interest in identifying and improving behaviors that threaten team performance and patient safety. Three hundred and sixty degree evaluations of surgeons were performed at 8 academically affiliated hospitals with a common Code of Excellence. We evaluate participant perceptions and make recommendations for future use. STUDY DESIGN: Three hundred and eighty-five surgeons in a variety of specialties underwent 360-degree evaluations, with a median of 29 reviewers each (interquartile range 23 to 36). Beginning 6 months after evaluation, surgeons, department heads, and reviewers completed follow-up surveys evaluating accuracy of feedback, willingness to participate in repeat evaluations, and behavior change. RESULTS: Survey response rate was 31% for surgeons (118 of 385), 59% for department heads (10 of 17), and 36% for reviewers (1,042 of 2,928). Eighty-seven percent of surgeons (95% CI, 75%-94%) agreed that reviewers provided accurate feedback. Similarly, 80% of department heads believed the feedback accurately reflected performance of surgeons within their department. Sixty percent of surgeon respondents (95% CI, 49%-75%) reported making changes to their practice based on feedback received. Seventy percent of reviewers (95% CI, 69%-74%) believed the evaluation process was valuable, with 82% (95% CI, 79%-84%) willing to participate in future 360-degree reviews. Thirty-two percent of reviewers (95% CI, 29%-35%) reported perceiving behavior change in surgeons. CONCLUSIONS: Three hundred and sixty degree evaluations can provide a practical, systematic, and subjectively accurate assessment of surgeon performance without undue reviewer burden. The process was found to result in beneficial behavior change, according to surgeons and their coworkers.

Effects of the new Accreditation Council for Graduate Medical Education work hour rules on surgical interns: a prospective study in a community teaching hospital.

BACKGROUND: On July 1, 2011, the Accreditation Council for Graduate Medical Education (ACGME) eliminated 30-hour call in an attempt to improve resident wakefulness. We surveyed interns on the Newton Wellesley Hospital (NWH) surgery service before and after the transition from Q4 overnight call to a night float schedule. METHODS: For 15 weeks, interns completed weekly surveys including the Epworth Sleepiness Scale (ESS). The service changed to a night float schedule after 3 weeks (ie, first to 3-4 and then to 6 nights in a row). RESULTS: The average ESS score rose from 9.8 ± 5.2 to 14.9 ± 3.1 and 14.4 ± 4.5 (P = .042) on the 3/4 and 6/1 schedules, respectively. Interns were more likely to be abnormally tired on either night float schedule (relative risk = 2.86; 95% confidence interval, 1.17-6.97, P = .029). CONCLUSIONS: The new ACGME work hours increased the ESS scores among interns at NWH and caused interns to be more tired than interns on the Q4 schedule. This is likely caused by the multiple nights of poor sleep without a post-call day to make up sleep.

How many sunsets? Timing of surgery in adhesive small bowel obstruction: a study of the Nationwide Inpatient Sample.

BACKGROUND: Best practices promulgated by the Eastern Association for the Surgery of Trauma suggest that delay in surgery for adhesive small bowel obstruction (ASBO) should not exceed 5 days. This study aimed to probe the relationship between operative delay and adverse outcomes, defined as occurrence of a complication, requirement for bowel resection, prolonged postoperative stay, or death in ASBO using the Nationwide Inpatient Sample. METHODS: We used the Nationwide Inpatient Sample for 2009. The relationship among days to surgery (preoperative days) and defined as occurrence of a defined set of complications, death during hospitalization, resection, and postoperative length of stay greater than 7 days (postoperative days > 7) was assessed, taking into account potential confounding factors using regression analysis. RESULTS: A total of 27,046 patients were identified with small bowel obstruction; 4,826 (18%) of these required surgery, and the remainder did not, staying a mean of 4 days (median, 3 days). Of the surgical group, 1,208 patients (25.0%) had Rsx, 1,527 (32%) had postoperative days of greater than 7, 138 (2.86%) died, 3,216 (66.7%) were female. Mean age was 62.2 years, mean total length of stay was 8.51 days, mean preoperative days was 1.94 days. Odds ratio (OR) of death for operated patients was 1.64 (95% confidence interval [CI], 1.11-2.19) when preoperative days was 4 or more. Postoperative days of greater than 7 was more likely if surgery preoperative days were 4 or more (OR, 1.26; 95% CIs, 1.07-1.48). No relationship between complication and preoperative days was observed. CONCLUSION: Delay in management of small bowel obstruction is associated with death and longer postoperative stays. Delay was not associated with complication or bowel resection. These data lend support to a policy encouraging observation of ASBO for no more than 5 days. LEVEL OF EVIDENCE: Epidemiologic study, level III; therapeutic study, level IV.

Which risk model to use? Clinical implications of the ACS MRI screening guidelines.

The American Cancer Society (ACS) guidelines define the appropriate use of MRI as an adjunct to mammography for breast cancer screening. Three risk assessment models are recommended to determine if women are at sufficient risk to warrant the use of this expensive screening tool, however, the real-world application of these models has not been explored. We sought to understand how these models behave in a community setting for women undergoing mammography screening. We conducted a retrospective analysis of 5,894 women, who received mammography screening at a community hospital and assessed their eligibility for MRI according to the ACS guidelines. Of the 5,894 women, 342 (5.8%) were eligible for MRI, but we found significant differences in the number of eligible women identified by each model. Our results indicate that these models identify very different populations, implying that the ACS guidelines deserve further development and consideration.

Increased risk of postoperative deep vein thrombosis and pulmonary embolism in patients with inflammatory bowel disease: a study of National Surgical Quality Improvement Program patients.

HYPOTHESIS: Patients with inflammatory bowel disease (IBD) undergoing surgery are at increased risk for postoperative thromboembolism, including deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke. DESIGN: Retrospective cohort study. SETTING: Two hundred eleven hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program. PATIENTS: All 271,368 patients from the National Surgical Quality Improvement Program 2008 Participant Use Data File were examined, and 2249 patients with IBD were compared with 269,119 patients without IBD. MAIN OUTCOME MEASURES: Occurrence of DVT, PE, myocardial infarction, or stroke within 30 days of surgery. RESULTS: Of 268,703 National Surgical Quality Improvement Program patients, 2249 (0.8%) had IBD. There were 2665 cases of DVT or PE (1.0%). Occurrence of DVT or PE was more common in patients with IBD (2.5%) overall (P < .001). Nonintestinal surgical cases had a higher rate of DVT or PE (5.0%; P = .002). Regression analysis, controlling for confounders, confirmed that IBD was associated with increased risk for DVT or PE (odds ratio = 2.03; 95% CI, 1.52-2.70). For nonintestinal surgery, risk of DVT or PE for patients with IBD was increased (odds ratio = 4.45; 95% CI, 1.72-11.49). Inflammatory bowel disease had no effect on risk of postoperative myocardial infarction or stroke. CONCLUSIONS: Patients with IBD are at increased risk for developing postoperative DVT or PE. This risk persists when potential confounding variables are controlled for. Risk of DVT or PE appears to be even higher for patients with IBD who are having nonintestinal surgery. Cardiac and stroke risks do not appear to be increased by IBD. Perhaps standards for DVT and PE prophylaxis in these cases should be reconsidered.

Women's preferences for minimally invasive incisions.

STUDY OBJECTIVE: To determine whether traditional, robotic, or single-site laparoscopic incisions are more appealing to women. DESIGN: Descriptive study using a survey (Canadian Task Force classification III). SETTING: Single-specialty referral-based gynecology practice. PATIENTS: All patients older than 18 years who came for care to the Newton-Wellesley Hospital Minimally Invasive Gynecological Surgery Center from April 2, 2010, to June 30, 2010. INTERVENTIONS: Three identical photos of an unscarred female abdomen were each marked with a black pen to indicate typical incision lengths and locations for robotic, single-site, and traditional laparoscopic surgery. Subjects were then asked to rank these incisions in order of preference. Additional demographic and surgical history questions were included in the survey. MEASUREMENTS AND MAIN RESULTS: Two-hundred fifty of 427 patients (58.5%) returned surveys, and of these, 241 completed critical survey elements. Preference for traditional laparoscopic incisions was 56.4% (95% confidence interval [CI], 50.1%-62.7%), for a single incision was 41.1% (95% CI, 34.8%-47.3%), and for robotic surgery was 2.5% (95% CI, 0.5%-4.5%). Two-sample test of proportion (Z test) showed the difference in preference for traditional over the other methods to be significant: p = .007 for a single incision and p <.001 for robotic surgery. Multivariatble analysis for factors influencing choice of single-site incision demonstrated that Latina/Hispanic ethnicity was the only significant factor (p = .02). CONCLUSION: Women prefer both single-site and traditional laparoscopic incisions over robotic procedures. Inasmuch as aesthetics are an important consideration for many women and clinical outcomes are similar, during the informed-consent procedure, location and length of incisions should be included in the discussion of risks, benefits, and alternatives.

Presenting blood pressure in traumatic brain injury: a bimodal distribution of death.

BACKGROUND: Recent research explores the relationship between vital signs on arrival to the emergency department and early outcomes. This work has not included traumatic brain injury (TBI). We aimed to evaluate the relationship of the initial emergency department systolic blood pressure (EDSBP) with outcome. METHODS: By using the National Trauma Data Bank (v7), we analyzed patients older than 16 years with isolated moderate to severe blunt TBI. TBI was defined by International Classification of Diseases--9th Rev diagnosis codes and Abbreviated Injury Scale scores. We determined mortality rates while controlling for age, gender, race, payment type, and injury severity using logistic regression. Survival analysis was performed to determine 3-day survival rates. Scores and rates were plotted against EDSBP. RESULTS: A total of 7,238 patients were included in the analysis. Plots of adverse outcomes versus EDSBP demonstrated bimodal distributions. The mortality curve had one inflection point at EDSBP 120 mm Hg, indicating higher mortality when blood pressures were lower than this threshold. Another inflection began at EDSBP 140 mm Hg. The mortality rate was 21% when EDSBP was <120 mm Hg, 9% when it was between 120 mm Hg and 140 mm Hg, and 19% when EDSBP was ≥140 mm Hg. Multivariate analysis demonstrated that patients presenting with an EDSBP of <120 mm Hg and ≥140 mm Hg were 2.7 (95% confidence interval =2.13,3.48) and 1.6 (95% confidence interval =1.32,1.96) times more likely to die, respectively, than those who presented with a EDSBP of 120 mm Hg to 140 mm Hg. CONCLUSIONS: Mortality in moderate to severe TBI has a bimodal distribution. Like hypotension, hypertension at hospital admission seems to be associated with increased mortality in TBI, even after controlling for other factors.

Are there racial disparities in trauma care?

BACKGROUND: A number of recent studies have demonstrated disparity between racial groups in both outcome and processes of trauma care. These were not controlled for the presence of shock. METHODS: We used data from the National Trauma Databank (NTDB) (version 6.0) to evaluate mortality, length of hospital stay, and discharge disposition for patients who suffered gunshot wounds (GSW) or who were drivers in motor vehicle crashes (MVC). Using regression analysis to control for age, gender, first measured systolic blood pressure, geographic region, trauma center verification status, and hospital teaching status, we looked for differences in trauma care outcomes by race as represented in the NTDB. RESULTS: We included 235,557 MVC victims and 13,378 GSW victims in our analysis. When potential confounding variables were accounted for, there were no differences in mortality based on race in either group, with the exception that Hispanic motor vehicle drivers suffered higher mortality, OR: 1.72 (95% CI: 1.36, 2.19; p<.001). Both Blacks and Hispanics had shorter lengths of stay in linear regression models (p<.001 in both cases) than whites. Blacks and Hispanics were less likely to be discharged home when compared to white patients (OR 0.83, 95% CI 0.80-0.86 for Blacks, and OR 0.53, 95% CI 0.50-0.56 for Hispanics). Shock, as reflected by first systolic blood pressure reported, and to a lesser degree, anatomic injury, as measured by Injury Severity Score (ICISS), were much more powerful predictors of outcome than race in all analyses. CONCLUSIONS: We found no mortality differences based on race for GSW. Hispanics have a higher mortality rate for MVC. For both injury types, Blacks and Hispanics had shorter hospital stays and a greater likelihood of transfer to post-acute care when compared to white patients. Hypotension on admission has a much more significant impact on outcome than race and ethnicity.

Analysis of occupational exposures associated with emergency department thoracotomy.

BACKGROUND: Although previous studies have examined the cost effectiveness of emergency department thoracotomy (EDT), provider risk has not been included in these analyses. This study examined the costs associated with provider exposure to human immunodeficiency virus (HIV) and hepatitis from percutaneous injury during EDT. METHODS: A decision tree describing the occupational risks and costs associated with EDT was created. Exposed providers undergo initial counseling, evaluation, and HIV postexposure prophylaxis and treatment as recommended by the Centers for Disease Control. Costs are reported from a health care system perspective in year-2000 dollars. The following prevalences were assumed: HIV (7.1%), hepatitis C (18%), and provider percutaneous injury rate (10%). Sensitivity analyses were performed by varying the prevalence of disease and the probability of seroconversion. RESULTS: According to the authors' model assumptions, the probability is 0.00004 for HIV and 0.0027 for chronic hepatitis C seroconversion. The total additional cost per thoracotomy associated with an exposure is dollars 1,377. CONCLUSIONS: Emergency department thoracotomy is associated with important provider medical risks. Future analyses of EDT should include these factors in reports on the value of this procedure.

Factors associated with mortality in trauma: re-evaluation of the TRISS method using the National Trauma Data Bank.

BACKGROUND: TRISS remains a standard method for predicting survival and correcting for severity in outcome analysis. The National Trauma Data Bank (NTDB) is emerging as a major source of trauma data that will be used for both primary research and outcome benchmarking. We used NTDB data, to determine whether TRISS is still an accurate predictor of survival coefficients and to determine whether the ability of TRISS to predict survival could be improved by updating the coefficients or by building predictive models that include information on co-morbidities. METHODS: To compare the utility of different methods of TRISS calculation we identified the records of 72,517 trauma patients (62,103 blunt trauma and 10,414 penetrating trauma) who had complete information for all of the covariates to be considered in the analysis. Multiple logistic regression was used to recalculate the TRISS coefficients in models using both the original TRISS covariates and in models which also included variables for co-morbidities that could potentially affect survival. Model discrimination was evaluated by calculating the area under the receiver operating characteristic curves (AUC), and model calibration was evaluated with the Hosmer-Lemeshow Goodness-of-Fit Statistic (H-L). RESULTS: For penetrating trauma the original TRISS equation had good discriminative ability (AUC=0.98), but was poorly calibrated (H-L=267.04). When logistic regression was used to generate revised coefficients, discrimination was unchanged, but calibration improved (H-L=38.66). The only co-morbid factor significantly associated with survival after penetrating trauma was acute alcohol consumption, which was associated with increased survival (p < 0.0001). However, its inclusion in a logistic model did not improve discrimination, but improved calibration somewhat (AUC =0.98; H-L=19.95). The original TRISS equation was a less accurate predictor of survival after blunt trauma (AUC = 0.84; H-L= 10,720.7). When logistic regression was used to generate revised coefficients for the original TRISS covariates, predictions after blunt trauma improved (AUC = 0.94; H-L=25.45). With blunt trauma, acute alcohol consumption and prior hypertension were associated with increased survival, and male gender, congestive failure, cirrhosis, and prior myocardial infarction were associated with decreased survival. However, inclusion of these covariates in a logistic model did not improve predictions of survival (AUC = 0.94; H-L= 34.83). CONCLUSIONS: In the NTDB the traditional TRISS had limited ability to predict survival after trauma. Accuracy of prediction was improved by recalculating the TRISS coefficients, but further improvements were not seen with models that included information about co-morbidities.

Outcomes and costs of acute treatment of traumatic brain injury.

BACKGROUND: Although there are nearly a quarter of a million hospitalizations for traumatic brain injury (TBI) in the United States each year, data on the outcomes and costs of TBI treatment in the acute-care setting are limited. METHODS: Using a large, geographically diverse, multihospital database, we examined inpatient records for persons aged 16 years or older who were hospitalized for TBI between January 1, 1997, and June 30, 1999. Patients were stratified by TBI severity using an adaptation of the Abbreviated Injury Scale for administrative data (ICD/AIS), as follows: 2 = "moderate"; 3 = "serious"; 4 = "severe"; and 5 = "critical." Patient characteristics, patterns of treatment, and outcomes and costs were examined by injury severity and mechanism of injury. RESULTS: Of 8,717 study subjects identified, 12.5% had moderate, 44.8% had serious, 29.6% had severe, and 13.2% had critical TBI. Falls were the most common reported cause of injury (40.8%), followed by motor vehicle crashes (39.3%), blows to the head (11.3%), and gunshot wounds (2.4%). Average length of stay in hospital ranged from 6.7 days for moderate TBI to 17.5 days for critical TBI. The overall rate of death in hospital was relatively low among patients with moderate (1.3%), serious (5.7%), and severe (8.7%) TBIs, but much higher among the most critically injured patients (52.0%). Costs of hospitalization averaged 8,189 dollars for moderate, 14,603 dollars for serious, 16,788 dollars for severe, and 33,537 dollars for critical TBI. Costs also varied by injury type, averaging 20,084 dollars for gunshot wounds, 20,522 dollars for motor vehicle crashes, 15,860 dollars for falls, and 19,949 dollars for blows to the head. CONCLUSION: The economic burden of TBI in the acute-care setting is substantial; treatment outcomes and costs vary considerably by TBI severity and mechanism of injury.

Guidelines for improving nutritional delivery in the intensive care unit.

Optimizing nutritional delivery in the intensive care unit (ICU) continues to be a challenge. Nutritional guidelines were developed at a metropolitan Level I trauma center as an institutional response to ensure the timeliness of patient evaluation, initiation of therapy, and attainment of goal therapy. A post-implementation review of 525 consecutive ICU patients revealed that the guidelines enabled the staff to evaluate 86% of all ICU patients and initiate appropriate therapy in 68% of them within 48 hours of admission. Goal therapy was achieved in more than 90% of patients within 72 hours. The establishment of nutritional guidelines is an integral step to improving nutritional therapy in the ICU.

Fracture locations influence the likelihood of rectal and lower urinary tract injuries in patients sustaining pelvic fractures.

BACKGROUND: Rectal and lower urinary tract injuries in pelvic fractures can lead to significant complications. We sought to determine whether fracture locations could serve as markers for injury. METHODS: In our retrospective review of patients with blunt pelvic fractures, the association of fracture locations with injury to the rectum, bladder, and urethra was explored with Fisher's exact test and subsequently analyzed with multiple logistic regression. RESULTS: Of the 362 patients reviewed, 8 had rectal injury and 24 had lower urinary tract injury. The following locations were found to be significant. Rectum: symphysis pubis (relative risk [RR] = 3.3, p < 0.001) and sacroiliac (SI) joint (RR = 2.1, p = 0.014). Bladder: symphysis pubis (RR = 2.1, p < 0.001), SI joint (RR = 2.0, p < 0.001), and sacrum (RR = 1.6, p = 0.002). Urethra: symphysis pubis (RR = 2.9, p = 0.003), SI joint (RR = 1.8, p = 0.04), and inferior ramus (RR = 4.6, p = 0.008). After multivariate analysis, the primary and independent predictors for each of the injuries were as follows: rectal injury, widened symphysis; bladder injury, widened symphysis and SI joint; and urethral injury, widened symphysis and fracture of the inferior pubic ramus. Although these associations were significant, the overall prevalence of associated rectal and urologic injuries was low. Consequently, the predictive values of these radiologic findings were also low, ranging from 5% to 9% for urethral and rectal injuries to 20% for bladder injuries. CONCLUSION: Certain fracture locations are associated with increased risk for rectal, bladder, or urethral injury. Fractures involving these locations should prompt further work-up for assessment.