Thresholds in PROMIS Scores Anchored to Subsequent Unscheduled Health Service Use Among People Diagnosed With Cancer.

PURPOSE: To establish thresholds in the Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference, physical function, fatigue, and depression scores on the basis of their association with subsequent use of the emergency department (ED) or urgent care by people diagnosed with cancer. METHODS: Retrospective data from 952 people seen at Henry Ford Cancer and insured through the Health Alliance Plan were analyzed using generalized linear mixed-effects models. The log odds of ED or urgent care use during 14 or 30 days after each patient-reported outcome (PRO) assessment were related to PRO scores, while adjusting for comorbidity, sociodemographic, and tumor characteristics. RESULTS: Pain interference and physical function were associated with subsequent ED or urgent care visits, but fatigue and depression were not, and the results for 14- and 30-day visits were similar. Thresholds anchored in the likelihood of these visits differed according to cancer stage. For people with advanced cancer, a pain interference score of 60 or higher (odds ratio [OR] 3.75, [95% CI, 1.53 to 7.87]) and a physical function score lower than 40 (OR 2.94, [95% CI, 1.22 to 7.06]) produced the largest ORs with narrowest CIs for 30-day visits. For people with nonadvanced cancer, the thresholds of 65 for pain interference (OR 2.64, [95% CI, 1.40 to 5.01]) and 35 for physical function (OR 1.87, [95% CI, 1.01 to 3.45]) produced largest ORs with narrowest CIs for 30-day visits. CONCLUSION: These anchor-based thresholds in PROMIS scores can inform clinicians' actions with the goal of preventing ED or urgent care visits.

Real time patient-reported outcome measures in patients with cancer: Early experience within an integrated health system.

BACKGROUND: While patient-reported outcome measures (PROMs) have benefit in cancer clinical trials, real-world applications are lacking. This study describes the method of implementation of a cancer enterprise-wide PROMs platform. METHODS: After establishing a multispecialty stakeholder group within a large integrated health system, domain-specific instruments were selected from the National Institutes of Health's Patient-Reported Outcomes Measurement Information System (PROMIS) instruments (pain interference, fatigue, physical function, and depression) and were administered at varying frequencies throughout each patient's cancer journey. All cancer patients with an oncologic visit were eligible to complete the PROMs prior to the visit using a patient portal, or at the time of the visit using a tablet. PROMs were integrated into clinical workflow. Clinical partnerships were essential for successful implementation. Descriptive preliminary data were compared using multivariable logistic regression to determine the factors associated with method of PROMs completion. RESULTS: From September 16, 2020 to July 23, 2021, 23 of 38 clinical units (60.5%) implemented PROMs over 2392 encounters and 1666 patients. Approximately one third of patients (n = 629, 37.8%) used the patient portal. Black patients (aOR 0.70; 95% CI: 0.51-0.97) and patients residing in zip codes with higher percentage of unemployment (aOR: 0.07, 95% CI: 0.01-0.41) were among the least likely to complete PROMs using the patient portal. CONCLUSIONS: Successful system-wide implementation of PROMs among cancer patients requires engagement from multispecialty stakeholders and investment from clinical partners. Attention to the method of PROMs collection is required in order to reduce the potential for disparities, such as Black populations and those residing in areas with high levels of unemployment.

Racial Differences in Planned Hysterectomy Procedure Route.

Background: Hysterectomies can be performed with a minimally invasive surgical (MIS) approach or a laparotomic (abdominal) approach. The objective of this study was to assess any racial differences in the likelihood of having a planned MIS hysterectomy. Materials and Methods: A prospective cohort study of women undergoing hysterectomy at Henry Ford Health System was conducted where laparotomic and MIS approaches are available to all patients. All procedures were performed between October, 2015, and August, 2017. For this study, women were asked to report demographic and insurance information and complete validated questionnaires from 2 weeks before hysterectomy and up to six additional times in the year after hysterectomy. Clinical and operative characteristics were collected from electronic health records. Logistic regression and multinomial logistic regression models were applied to assess the association between race and the surgical approach. Results: Analyses included 235 White women and 196 Black women. Black women were less likely to have any MIS planned for their hysterectomy (odds ratio [OR] = 0.46, 95% confidence interval [CI] 0.3-0.71, p < 0.05), a laparoscopic hysterectomy (relative risk ratio [RRR] = 0.46, 95% CI 0.29-0.73, p < 0.05), or a vaginal hysterectomy (RRR = 0.45, 95% CI 0.25-0.81, p = 0.01) compared with White women. After adjusting for confounders, uterine weight and indication for surgery was fibroids, these racial differences did not remain statistically significant (MIS vs. abdominal [adjusted odds ratio {aOR} = 0.93, 95% CI 0.55-1.57, p = 0.79], laparoscopic vs. abdominal [adjusted relative risk ratio {aRRR} = 0.89, 95% CI 0.52-1.51, p = 0.54], and vaginal vs. abdominal [aRRR = 1.22, 95% CI 0.61-2.45, p = 0.58]). The associations were not confounded by the baseline survey data from standardized questionnaires on depression, financial distress, and satisfaction with their decision. Conclusions: Black women were not less likely than White women to have planned an MIS hysterectomy after controlling for important confounding variables. These results emphasize the importance of considering all important confounders when examining racial differences.

The Effects of Harm Events on 30-Day Readmission in Surgical Patients.

ABSTRACT: Readmission is an increasingly important focus for improvement regarding quality, value, and patient burden in our surgical patient population. We hypothesized that inpatient harm events increase the likelihood of readmission in surgical patients. We created a system-wide inpatient registry with 30-day readmission. A surgical subset was created, and harm events were tracked through the electronic health record system. Between 2015 and 2017, 37,048 surgical patient encounters met inclusion criterion. A total of 2,887 patients (7.69%) were readmitted. After multiple logistic regression of the highly significant harm measures, seven harm measures remained statistically significant (p < .05). Those with the three highest odds ratios were mucosal pressure ulcer, Clostridium difficile, and glucose <40. Incorporating harm measures to the traditional risk, predictive model for 30-day readmission improved our model performance (area under the ROC curve from 0.68 to 0.71). This study demonstrated that inpatient hospital-based harm events can be electronically monitored and used to predict 30-day readmission.

A Prospective Study of Patterns of Regret in the Year After Hysterectomy.

PURPOSE: This study sought to identify patterns of self-reported regret after hysterectomy. METHODS: Women undergoing hysterectomy for a benign indication were recruited in the 2 weeks prior to surgery. Women reported demographics and completed validated questionnaires (Decisional Regret Scale, Patient Health Questionnaire-9, Decisional Conflict Scale, and the Comprehensive Score for Financial Toxicity) up to 7 times over the first year postsurgery. Medical records were reviewed for clinical and operative details. Latent class growth mixture models were applied to the repeated regret scores to identify patterns after hysterectomy. Clinical and other participant characteristics were compared across the classes. RESULTS: Three latent classes were identified among the 459 participants (422 of whom completed questionnaires at 12 months): "High Regret" (7.4%), women with a high regret score at baseline that did not improve over time; "Decreasing Regret" (13.3%), women with high baseline levels of regret but whose regret scores improved over time; and "Least Regret" (79.3%), women with the lowest baseline regret scores that remained low after surgery. These classes did not vary with respect to indication for surgery, clinical characteristics, age, or body mass index. Disproportionately more African American women (adjusted odds ratio: 1.99, 95% CI: 1.01-3.9) were in the "Decreasing Regret" versus "Least Regret" classes. Baseline satisfaction varied between the classes, with the "Least Regret" group having higher baseline satisfaction with their decision. Women with "Decreasing Regret" reported worse financial toxicity associated with surgery versus women in the "Least Regret" class (adjusted odds ratio: 0.95, 95% CI: 0.92-0.99). CONCLUSIONS: For some women, decisional regret may worsen after hysterectomy. More often, initial regret lessens over time. Future studies that identify factors strongly associated with self-reported regret could lead to improved counseling about postsurgical expectations.

Healthcare Professionals Risk Assessments for Alert Overrides in High-Risk IV Infusions Using Simulated Scenarios.

This study aimed to use healthcare professionals' assessments to calculate expected risk of intravenous (IV) infusion harm for simulated high-risk medications that exceed soft limits and to investigate the impact of relevant risk factors. We designed 30 infusion scenarios for four high-risk medications, propofol, morphine, insulin, and heparin, infused in adult intensive care unit (AICU) and adult medical and surgical care unit (AMSU). A total of 20 pharmacists and 5 nurses provided their assessed expected risk of harm in each scenario. Descriptive statistics, analysis of variance with least square mean, and post hoc test were conducted to test the effects of field limit type, soft (SoftMax), and hard maximum drug limit types (HardMax), and care area-medication combination on risk of harm. The results showed that overdosing scenarios with continuous and bolus dose limit types were assessed with significantly higher risks than those of bolus dose rate type. An overdose infusion in AICU over a large SoftMax was assessed to be of higher risk than over a small one, but not in AMSU. For overdose infusions with three levels of drug amount, greater drug amount in AICU and AMSU was assessed to have higher risk, except insignificant risk difference between the infusions with higher and moderate drug amount in AMSU. This study obtained expected risk for simulated high-risk IV infusions and found that different field limit and SoftMax types can affect expected risk based on healthcare professionals' perspectives. The findings will be regarded as benchmarks for validating risk quantification models in future research.

Patient Perceptions of Planned Organ Removal During Hysterectomy.

PURPOSE: Previous reports indicate many women may not have a firm grasp on likely outcomes of different hysterectomy procedures. This study aimed to assess women's self-reported expectations of how they think their anatomy will change after hysterectomy. METHODS: Women scheduled for hysterectomy at a tertiary care hospital, for non-oncological reasons, reported their planned procedure type and the organs they understood would be removed 2 weeks prior to surgery. Patient reports and electronic medical records were reviewed, and kappa statistics (κ) were calculated to assess agreement for all women and within subgroups. RESULTS: Most of the 456 study participants (mean age: 48.02 ± 8.29 years) were either white/Caucasian (n=238, 52.2%) or African American (n=196, 43.0%). Among the 145 participants who reported a partial hysterectomy, 130 (89.7%) women indicated that their uterus would be removed and 52 (35.9%) reported that their cervix would be removed. Of those whose response was total hysterectomy (n=228), 208 (91.2%) participants reported their uterus would be removed and 143 (62.7%) reported their cervix would be removed. Among 144 women reporting a planned partial hysterectomy, only 15 (10.4%, κ=0.05) had a partial hysterectomy recorded in the electronic medical record. Among the 228 women who reported a planned total hysterectomy, 6.1% (κ=0.05) had a different procedure. While 125 participants reported planned ovary removal, only 93 (74.4%, κ=0.55) had an oophorectomy. Similarly, 290 participants reported planned fallopian tube removal, with 276 (95.2%, κ=0.06) having a salpingectomy. CONCLUSIONS: A considerable proportion of women undergoing hysterectomy do not accurately report the organs that are planned be removed during their hysterectomy. This work demonstrates the need to improve patient understanding of their clinical care and its implications.

High-alert medication administration and intravenous smart pumps: A descriptive analysis of clinical practice.

BACKGROUND: The Institute for Safe Medication Practices (ISMP) describes high alert medications (HAM) as medications that represent a heightened risk of patient harm when used in error. IV smart pumps with dose error reduction systems (DERS) were created to help address medication administration errors. Compliance with DERS provides a measure of how accurately a hospital uses smart pump technology to reduce IV medication error. OBJECTIVE: The primary purpose of this research was to use the REMEDI dataset, an aggregate, multi-hospital database inclusive of smart pump analytics, to improve the current understanding of clinical practices for IV HAM administration. METHODS: Descriptive analyses and analysis of variance (ANOVA) were used to test for differences in the mean DERS alert override rate, and mean DERS alert override to reprogram ratio between non-HAM and HAM overall, by hospital system, and by pump type. RESULTS: High mean override rates for non-HAM (73.8%) and HAM (75.8%) and high override to reprogram ratios for both non-HAM (7.30) and HAM (9.92) were seen. No significant differences were found in override rates (p = 0.23) and override to reprogram ratios (p = 0.06) between non-HAM and HAM. By hospital system, significant variability in override rates and override to reprogram ratios were seen. By pump type, there were no significant differences in the mean override rates (Baxter: p = 0.09; BD p = 0.34; ICU Medical p = 0.18) and the mean override to reprogram ratios (Baxter p = 0.84; BD p = 0.03; ICU Medical p = 0.63) between non-HAM and HAM. CONCLUSIONS: These findings indicate that the majority of alerts generated are bypassed by clinicians at the point of care, a symptom of alert fatigue. Given the potential for significant patient harm with HAM and the high DERS alert override rates that routinely occur during IV medication administration, this study provides further support for clinician-driven IV smart pump innovation to improve alert fatigue.

Induction of liver-specific intrahepatic myeloid cells aggregation expands CD8 T cell and inhibits growth of murine hepatoma.

Toll-Like Receptor 9 (TLR9) stimulation selectively triggers the formation of a cell cluster termed intrahepatic myeloid aggregation for T cell expansion" (iMATE) in a mouse chronic viral hepatitis model. iMATE expands cytotoxic T cells and controls viral hepatitis infection. The liver-specific immune response prompted this investigation of whether the effect could control tumor growth in the murine hepatic tumor model. Murine hepatic BNL cells were used to establish an orthotropic liver tumor model. We found that intravenous infusion of TLR 9 agonist, CpG oligodeoxynucleotide (ODN) induced iMATE formation in non-tumor parts of liver and suppressed the murine BNL tumor growth. The ratio of intra-tumor CD8+ T cells have increased after CpG ODN. These cells expressed higher levels of effector and checkpoint molecules, and produce more Th1 cytokine upon ex vivo stimulation. The CD11b+Ly6ChiLy6G - subset of CD11b+ myeloid cells in the tumor microenvironment has increased. Both CD11b+Ly6ChiLy6G - and CD11b+Ly6CloLy6G+ subsets expressed higher level of interferon-gamma post CpG ODN treatment, although still presented a suppressive phenotype. Their suppressive ability was decreased, instead, the targeted CD8+ T cell proliferation was promoted at a higher dose of CD11b+Ly6ChiLy6G- cells. The phenomenon was further proven in DEN induced liver tumor model. In conclusion, systemic CpG ODN treatment induced iMATE formation that expanded effector CD8+ T cells to control tumor growth in the mouse hepatic tumor model. This novel strategy provides a new rationale for liver-specific tumor immunotherapy.

Intravenous Smart Pump Drug Library Compliance: A Descriptive Study of 44 Hospitals.

BACKGROUND: Although intravenous (IV) smart pumps with built-in dose-error reduction systems (DERS) can reduce IV medication administration error, most serious adverse events still occur during IV medication administration. Sources of error include overriding DERS and manually bypassing drug libraries and the DERS. METHODS: Our purpose was to use the Regenstrief National Center for Medical Device Informatics data set to better understand IV smart pump drug library and DERS compliance. Our sample consisted of 12 months of data from 7 hospital systems, 44 individual hospitals, and descriptive data from the American Hospital Directory (AHD) for 2015. The aims of the study were (1) to determine whether there are differences in IV smart pump drug library compliance between hospital systems and (2) to provide a broad descriptive overview of relevant trends related to IV smart pump compliance. RESULTS: For aim 1, we found 3 significant relationships among the 7 hospital systems: systems 3 (P < 0.001), 6 (P = 0.003), and 7 (P = 0.002) had significantly higher IV smart compliance as compared with system 4. For aim 2, the number of drug library profiles was positively correlated (P = 0.029) with IV smart pump compliance and the IV smart pump type used was significantly correlated (P = 0.013) with IV smart pump compliance. CONCLUSIONS: Our findings support that there are differences in IV smart pump compliance both within and between hospital systems and that IV smart pump type and the number of drug library profiles may be influencing factors. Further research is required to more accurately identify the impact of these factors in this very important area of patient safety.

Apoptosis of tumor infiltrating effector TIM-3+CD8+ T cells in colon cancer.

TIM-3 functions to enforce CD8+ T cell exhaustion, a dysfunctional state associated with the tolerization of tumor microenvironment. Here we report apoptosis of IFN-γ competent TIM-3+ population of tumor-infiltrating CD8+ T cells in colon cancer. In humans suffering from colorectal cancer, TIM-3+ population is higher in cancer tissue-resident relative to peripheral blood CD8+ T cells. Both the TIM-3+ and TIM-3- cancer tissue-resident CD8+ T cells secrete IFN-γ of comparable levels, although apoptotic cells are more in TIM-3+ compared to TIM-3- population. In mouse CT26 colon tumor model, majority of tumor-infiltrating CD8+ T cells express TIM-3 and execute cytolysis function with higher effector cytokine secretion and apoptosis in TIM-3+ compared to TIM-3- population. The tumor cells secrete galectin-9, which increases apoptosis of tumor-infiltrating CD8+ T cells. Galectin-9/TIM-3 signaling blockade with anti-TIM-3 antibody reduces the apoptosis and in addition, inhibits tumor growth in mice. The blockade increases therapeutic efficacy of cyclophosphamide to treat tumor in mice as well. These results reveal a previously unexplored role of TIM-3 on tumor-infiltrating CD8+ T cells in vivo.