Characterizing Fit-for-Purpose Real-World Data: An Assessment of a Mother-Infant Linkage in the Japan Medical Data Center Claims Database.

Purpose: Observational postapproval safety studies are needed to inform medication safety during pregnancy. Real-world databases can be valuable for supporting such research, but fitness for regulatory purpose must first be vetted. Here, we demonstrate a fit-for-purpose assessment of the Japan Medical Data Center (JMDC) claims database for pregnancy safety regulatory decision-making. Patients and Methods: The Duke-Margolis framework considers a database's fitness for regulatory purpose based on relevancy (capacity to answer the research question based on variable availability and a sufficiently sized, representative population) and quality (ability to validly answer the research question based on data completeness and accuracy). To assess these considerations, we examined descriptive characteristics of infants and pregnancies among females ages 12-55 years in the JMDC between January 2005 and March 2022. Results: For relevancy, we determined that critical data fields (maternal medications, infant major congenital malformations, covariates) are available. Family identification codes permitted linkage of 385,295 total mother-infant pairs, 57% of which were continuously enrolled during pregnancy. The prevalence of specific congenital malformation subcategories and maternal medical conditions were representative of the general population, but preterm births were below expectations (3.6% versus 5.6%) in this population. For quality, our methods are expected to accurately identify the complete set of mothers and infants with a shared health insurance plan. However, validity of gestational age information was limited given the high proportion (60%) of missing live birth delivery codes coupled with suppression of infant birth dates and inaccessibility of disease codes with gestational week information. Conclusion: The JMDC may be well suited for descriptive studies of pregnant people in Japan (eg, comorbidities, medication usage). More work is needed to identify a method to assign pregnancy onset and delivery dates so that in utero medication exposure windows can be defined more precisely as needed for many regulatory postapproval pregnancy safety studies.

Real-world assessment of the treatment patterns and outcomes among patients with multiple myeloma across different risk stratification criteria in the United States: a retrospective cohort study.

This study evaluated prognostic performance of International Staging System (ISS), revised ISS, and chromosomal abnormalities (CA) in newly diagnosed multiple myeloma patients to describe treatment patterns (cohort 1; n = 1979) and survival outcomes (cohort 2; n = 1382). In both cohorts, ∼18%, 41%, and 37% of patients were high-risk according to the R-ISS, ISS, and high-risk CA criteria, respectively. Across all risk stratification criteria, 60% of patients received triplets. In cohort 2, the median modified progression-free survival decreased with each increasing risk stage (23.5, 12.1, and 8.8 months in R-ISS I, II, and III, respectively, and 16.0, 12.7, and 10.4 months in ISS I, II, and III). Similar trends were observed in the proportions of two-year overall survival. In conclusion, R-ISS has greater discriminatory power than ISS or high-risk CA alone and can be implemented in a real-world setting. Accordingly, a more risk-adapted approach can be feasible, with a greater population-level impact.

Patient characteristics, treatment patterns, and mortality in elderly patients newly diagnosed with acute myeloid leukemia meeting ineligibility criteria for high intensity chemotherapy.

To describe patient characteristics, treatment patterns, and survival among elderly patients (≥66 years) newly diagnosed with acute myeloid leukemia (AML) meeting ≥1 ineligibility criteria for high-intensity chemotherapy (HIC; i.e. age >75 years, cardiac disease/prior anthracycline therapy, or secondary AML), we analyzed 2007-2017 100% Medicare hematologic cancer data. Patients were stratified based on whether they received HIC or low-intensity chemotherapy (LIC) or best supportive care (BSC) within 60 days after AML diagnosis. Of 4,152 patients, 43.2% received chemotherapy, 33.8% BSC, and 23.1% no therapy. Among chemotherapy-treated patients, HIC was more common than LIC (58.8 vs 41.2%), despite targeting patients meeting ≥1 ineligibility criteria for HIC. Poor overall survival was observed for patients receiving chemotherapy and BSC (median overall survival [interquartile range]: HIC, 1.9 [0.8, 6.6] months; LIC, 3.8 [1.4, 9.3] months; BSC, 1.0 [0.4, 2.5] months). Results highlight the need for additional effective and tolerable treatments for this population.

Evolution of Single-Use Urologic Endoscopy: Benchtop and Initial Clinical Assessment of a New Single-Use Flexible Cystoscope.

Introduction: Office cystoscopy is one of the most frequently performed procedures by a urologist. However, single-use cystoscopes remain quite undeveloped. Ambu® has developed single-use broncoscopes, rhinolaryngoscopes, and duodenoscopes. Recently, they released a single-use cystoscope. In this study, we performed a benchtop and an initial clinical assessment of the Ambu aScope™ (4) Cysto (aS4C) single-use cystoscope. Materials and Methods: Ten new, never-used aS4C single-use cystoscopes were assessed for optical performance, maximal tip flexion, and irrigation flow rate with empty working channel, 365 µm laser fiber, 0.035 in hydrophilic-tipped wire, 1.9F nitinol basket, and a 1.8 mm flexible stent grasper. All cystoscopes were then fully flexed 25 times in each direction, and maximal flexion angles were remeasured with and without instruments. Optical resolution, distortion, and depth of field were measured and compared with our reusable digital flexible cystoscopes. Assessment of clinical use was performed for inpatient bedside procedures using a Likert feedback survey and the NASA Task Load Index. Results: Maximal upward flexion exceeded 200° and 160° for all working instruments in upward and downward flexion. Downward flexion demonstrated different flexion between instrument groups in pre- and postcycling (p < 0.001). There was no clinical difference between the pre- and postcycling flexion. Flow rate decreased with increasing working instrument size (p < 0.001). The Olympus HD cystoscope resolution was superior at 3 and 5 mm distance, but not at other distances. The Ambu scope was superior to the Olympus SD scope at all distances except 3 mm. The aS4C had higher Likert scale survey scores for clinical use. Conclusions: The new Ambu single-use cystoscope demonstrates good flexion across instruments and comparable optics with reusable cystoscopes. In addition, initial inpatient bedside use of the aS4C and Monitor system compares favorably with the Olympus reusable cystoscope. Further testing in clinical scenarios such as hematuria, urothelial carcinoma, and operative endoscopy is warranted.

A Prospective Assessment of Opioid Utilization Post-Operatively in Orthopaedic Sports Medicine Surgeries.

BACKGROUND: The healthcare system is plagued finding the balance between opioid use and abuse. Orthopaedic surgeons are expected to curtail the number of opioids prescribed in order to lower opioid abuse. We sought to prospectively evaluate opioid consumption following a wide range of sports orthopaedic surgical procedures to determine utilization patterns. METHODS: All patients receiving procedures within a one-year period were consented and then called daily for one week followed by weekly for up to two months or until the patients no longer were taking their opioid medication. We studied the number of opioids patient's took postoperatively and also collected information in regards to the patient and the surgical procedure. RESULTS: Included were 223 patients with a mean age of 32.9 years (range, 11 to 82). Surgeons prescribed a mean total of 59.5 pills, and patients reported consuming a mean total of 20.9 pills, resulting in a utilization rate of 40%. 94.4% of patients received no education on how to properly dispose of unused opioids. The mean SANE score was 53.9. The mean Pain Catastrophizing Scale score was 15.1. The mean Opioid Risk Tool was 3.3. The procedures were broken down into: 47.5% ligamentous knee repair, 18.4% shoulder arthroscopy/other shoulder, 7.6% meniscus, 7.6% shoulder arthroplasty, 5.4% distal biceps, 4.0% lower leg (ankle/foot/tibia) and 4.0% shoulder ORIF. CONCLUSION: Over-prescribing opioids after sports orthopaedic surgeries is widespread. In this study, we found that patients are being prescribed 2.48 times greater opioid medications than needed following sports orthopaedic surgical procedures. We recommend surgeons take care when prescribing postoperative pain control and consider customizing their opioid prescriptions on the basis of prior opioid usage, anatomic location and procedure type. We also recommend educating the patients on proper disposal of excess opioids and consider involving pain management for patients likely to require prolonged opioid usage.

Effect of Patient Resilience and the Single Assessment Numeric Evaluation (SANE) Score on Return to Sport Following Anterior Cruciate Ligament Reconstruction Surgery.

BACKGROUND: This study aims to determine the effect of resilience, as measured by the Brief Resilience Scale (BRS), and perceived self-efficacy of knee function, as measured by the Single Assessment Numeric Evaluation (SANE) score on return to sport outcomes following ACL Reconstruction (ACLR) surgery. METHODS: Seventy-one patients undergoing ACLR surgery were followed up for a minimum of one year. At six-months post-op, ACLR patients completed the BRS and the SANE score. Patients were stratified into low, normal, and high resilience groups, and outcome scores were calculated. RESULTS: The median return to sports participation, in months post-operatively, for the low, normal, and high resiliency groups were 7.1, 7.3, and 7.2 months, respectively (P=0.78). A multiple logistic regression analysis revealed that the SANE score was a significant predictor of return to sport at nine months when adjusted for age, sex, and BRS score (P=0.01). Patients that returned to sport by nine months demonstrated a mean SANE score of 92.7, compared to a mean of 85.7 (P=0.08). In patients who had returned to sport, neither the BRS resilience group nor the SANE score were significant predictors of the returned level of competition status (P=0.06; P=0.18). CONCLUSION: The SANE score may serve as a significant predictor of return to sport when adjusted for age, sex, and BRS score. Resilience, as measured by the BRS, was not significantly associated with return to sport, but may have utility in specific patient populations.

Rotator cuff repair in HIV-positive patients ages 65 and older: only slight increase in risk of general postoperative surgical complications.

PURPOSE: To examine postoperative complications associated with rotator cuff repair (RCR) in HIV-positive patients ages 65 and older. METHODS: Data were collected from the Medicare Standardized Analytic Files between 2005 and 2015 using the PearlDiver Patient Records Database. Subjects were selected using Current Procedural Terminology (CPT) and International Classification of Diseases (ICD) codes. Demographics including age, sex, medical comorbidities, and smoking status were collected. Complications were examined at 7-day, 30-day, and 90-day postoperative time points. Data were examined with univariate and multivariate analyses. RESULTS: The study included 152,114 patients who underwent RCR, with 24,486 (16.1%) patients who were HIV-positive. Following univariate analysis, patients with HIV were observed to be more likely to develop 7-day, 30-day, and 90-day postoperative complications. However, the absolute risk of each complication was quite low for HIV-positive patients. Univariate and multivariate analysis showed that within 7 days following surgery, patients with HIV were more likely to develop myocardial infarction (OR 2.5, AR 0.1%) and sepsis (OR 2.5, AR 0.04%). Within 30 days, HIV-positive patients were at increased risk for postoperative anemia (OR 2.8, AR 0.1%), blood transfusion (OR 3.3, AR 0.1%), heart failure (OR 2.3, AR 0.8%), and sepsis (OR 2.7, AR 0.1%). Within 90 days, mechanical complications (OR 2.1, AR 0.1%) were increased in the HIV-positive group. CONCLUSION: Postoperative complications of RCR occurred at increased rates in the HIV-positive group compared to the HIV-negative group in patients ages 65 and older. In particular, increased risk for myocardial infarction, sepsis, heart failure, anemia, and mechanical complications was noted in HIV-positive patients. However, the actual percentage of patients who experienced each complication was low, indicating RCR is likely safe to perform even in older HIV-positive patients. As more older adults living with HIV present for elective orthopedic procedures, the results of the present study may reassure physicians who are considering RCR as an option for patients in this particular population, while also informing providers about potential complications. LEVEL OF EVIDENCE: III.

Febrile neutropenia-related care and associated costs in elderly patients with breast cancer, lung cancer, or non-Hodgkin lymphoma.

PURPOSE: Limited information is available regarding elderly patients experiencing febrile neutropenia (FN). This study evaluated FN-related care among elderly cancer patients who received high/intermediate FN-risk chemotherapy and experienced ≥ 1 FN episodes. METHODS: We used Medicare data to identify patients aged ≥ 66 years who initiated high/intermediate FN-risk chemotherapy between 1 January 2008 and 31 August 2015 to treat breast cancer (BC), lung cancer (LC), or non-Hodgkin lymphoma (NHL) and had ≥ 1 FN episodes. We identified within-cycle FN episodes for each chemotherapy cycle on Part A inpatient claims or outpatient or Part B claims. We described the FN-related care setting (inpatient hospital, outpatient emergency department [ED], or outpatient non-ED) and reported mean total cost of FN-related care per episode overall and by care setting (adjusted to 2015 US$). RESULTS: We identified 2138, 3521, and 2862 patients with BC, LC, and NHL, respectively, with ≥ 1 FN episodes (total episodes: 2407, 3840, 3587, respectively). Most FN episodes required inpatient care (BC, 88.1%; LC, 93.0%; NHL, 93.2%) with mean hospital length of stay (LOS) 6.2, 6.5, and 6.8 days, respectively. Intensive care unit admission was required for 20.4% of BC, 29.0% of LC, and 25.7% of NHL hospitalizations (mean LOS: 4.7, 4.7, 5.5 days, respectively). The mean total cost of FN care per episode was $11,959 BC, $14,388 LC, and $15,006 NHL, with inpatient admission the costliest care component ($11,826; $14,294; and $14,873; respectively). CONCLUSIONS: Among elderly patients with BC, LC, or NHL who experienced FN, most FN episodes required costly hospital care, highlighting the FN burden on healthcare systems.

Trends in the use of primary prophylactic colony-stimulating factors and neutropenia-related hospitalization in elderly cancer patients receiving myelosuppressive chemotherapy in the USA: 1995-2015.

PURPOSE: To assess changes in neutropenia-related hospitalization, myelosuppressive chemotherapy, and primary prophylactic colony-stimulating factor (PP-CSF) use in elderly cancer patients receiving myelosuppressive chemotherapy. METHODS: We identified annual cohorts of patients aged ≥ 66 years with breast cancer, lung cancer, or non-Hodgkin lymphoma (NHL) initiating myelosuppressive chemotherapy during 1995-2015 using Medicare 5% (1994-2008) and 20% (2007-2015) data. We described myelosuppressive chemotherapy changes by febrile neutropenia (FN) risk category (high, intermediate, unclassified), PP-CSF use, and, in the first cycle of myelosuppressive chemotherapy, neutropenia-related hospitalization (ICD-9-CM: 288.0X, first 5 positions). We evaluated hospitalization trends using a logistic regression model with spline curve of calendar year adjusting for baseline characteristics. RESULTS: Annual cohorts included 1451-2114 eligible patients for 1995-2007 and 5272-7603 for 2008-2015. Myelosuppressive chemotherapy use with high/intermediate FN risk increased from 31% in 1995 to 56% in 1999, stabilized through 2008 (range 56-61%), then decreased to 52% in 2015. PP-CSF use increased from 5.5% in 1995 to 52.7% in 2015, mainly due to pegfilgrastim introduction in 2002. Crude neutropenia-related hospitalization incidence decreased from 5.2% in 1995 to 2.7% in 2015; adjusted incidence decreased, on average, by 4.7% yearly before 2010 (p < 0.0001) and was flat from 2010 onward (p = 0.53). CONCLUSIONS: Among elderly patients with breast cancer, lung cancer, or NHL receiving myelosuppressive chemotherapy, PP-CSF use increased substantially after 2002. Neutropenia-related hospitalization incidence in the first cycle decreased yearly before 2010 and was flat afterward. Further studies are needed to understand overall decreasing neutropenia-related hospitalization trends and effects of changes in myelosuppressive chemotherapy and FN management.

Temporal trends in treatment and survival of older adult diffuse large B-Cell lymphoma patients in the SEER-Medicare linked database.

To describe temporal trends in treatment among older adult (≥66 years) patients diagnosed with diffuse large B-cell lymphoma (DLBCL), we analyzed 18,058 DLBCL patients from the Surveillance, Epidemiology, and End Results linked Medicare (SEER-Medicare) database diagnosed between 2001 and 2013. Among 65% of patients receiving treatment after diagnosis, R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) was the most common frontline therapy, increasing with more recent treatment year: 51% (2001-2003) vs. 69% (2010-2014). Autologous and allogeneic hematopoietic stem cell transplantation (HSCT) was uncommon in these Medicare patients. As the addition of rituximab increased over time, we also observed an improved survival rate over time. It is possible there is an association, but we cannot make this inference as effectiveness was not measured in this study. Overall survival estimates indicated that survival probabilities steadily improved in more recent years; however, 5-year survival was <40%, indicating the need for improved treatment options for older adult DLBCL patients.

Patient characteristics, treatment patterns, and mortality in elderly patients newly diagnosed with ALL.

To describe patient characteristics and treatment patterns among elderly patients (≥66 years) newly diagnosed with acute lymphoblastic leukemia (ALL), we analyzed 100% Medicare ALL data from 2007 to 2015. Only 764 out of 1428 (53.5%) elderly patients received treatment within 90 d of diagnosis with ≥30-d follow-up; 32.4% received chemotherapy without tyrosine kinase inhibitors (TKIs), 8.8% received both chemotherapy and TKIs, 9.8% received steroids only and 2.6% received TKIs only. Among 717 patients receiving chemotherapy any time during follow-up, 65.8% received only one course of treatment. Patients treated with chemotherapy or TKIs compared to untreated patients were younger (<75 years: 51.5 vs. 21.7%) and had a lower comorbidity burden (Charlson Comorbidity index ≤ 2: 90.9 vs. 71.4%). Overall, 67.5% of patients died within 3 years of diagnosis. Our findings demonstrate that many elderly ALL patients are not treated in the real-world setting and highlight the need for tolerable therapies for these patients.

Preventability of Early Versus Late Hospital Readmissions in a National Cohort of General Medicine Patients.

Background: Many experts believe that hospitals with more frequent readmissions provide lower-quality care, but little is known about how the preventability of readmissions might change over the postdischarge time frame. Objective: To determine whether readmissions within 7 days of discharge differ from those between 8 and 30 days after discharge with respect to preventability. Design: Prospective cohort study. Setting: 10 academic medical centers in the United States. Patients: 822 adults readmitted to a general medicine service. Measurements: For each readmission, 2 site-specific physician adjudicators used a structured survey instrument to determine whether it was preventable and measured other characteristics. Results: Overall, 36.2% of early readmissions versus 23.0% of late readmissions were preventable (median risk difference, 13.0 percentage points [interquartile range, 5.5 to 26.4 percentage points]). Hospitals were identified as better locations for preventing early readmissions (47.2% vs. 25.5%; median risk difference, 22.8 percentage points [interquartile range, 17.9 to 31.8 percentage points]), whereas outpatient clinics (15.2% vs. 6.6%; median risk difference, 10.0 percentage points [interquartile range, 4.6 to 12.2 percentage points]) and home (19.4% vs. 14.0%; median risk difference, 5.6 percentage points [interquartile range, -6.1 to 17.1 percentage points]) were better for preventing late readmissions. Limitation: Physician adjudicators were not blinded to readmission timing, community hospitals were not included in the study, and readmissions to nonstudy hospitals were not included in the results. Conclusion: Early readmissions were more likely to be preventable and amenable to hospital-based interventions. Late readmissions were less likely to be preventable and were more amenable to ambulatory and home-based interventions. Primary Funding Source: Association of American Medical Colleges.

Digital Footprint of Neurological Surgeons.

BACKGROUND: Patients are increasingly turning to online resources to inquire about individual physicians and to gather health information. However, little research exists studying the online presence of neurosurgeons across the country. This study aimed to characterize these online profiles and assess the scope of neurosurgeons' digital identities. METHODS: Medicare-participating neurologic surgeons from the United States and Puerto Rico were identified using the Centers for Medicare and Medicaid Services (CMS) Physician Comparable Downloadable File. Each physician was characterized by his or her medical education, graduation year, city of practice, gender, and affiliation with an academic institution. Using a Google-based custom search tool, the top 10 search results for each physician were extracted and categorized as 1 of the following: 1) physician, hospital, or healthcare system controlled, 2) third-party or government controlled, 3) social media-based, 4) primary journal article, or 5) other. RESULTS: Among the physicians within the CMS database, 4751 self-identified as being neurosurgeons, yielding a total of 45,875 uniform resource locator search results pertinent to these physicians. Of the 4751 neurosurgeons, 2317 (48.8%) and 2434 (51.2%) were classified as academic and nonacademic neurosurgeons, respectively. At least 1 search result was obtained for every physician. Hospital, healthcare system, or physician-controlled websites (18,206; 39.7%) and third-party websites (17,122; 37.3%) were the 2 most commonly observed domain types. Websites belonging to social media platforms accounted for 4843 (10.6%) search results, and websites belonging to peer-reviewed academic journals accounted for 1888 (4.1%) search results. The frequency with which a third-party domain appeared as the first search result was higher for nonacademic neurosurgeons than for academic neurosurgeons. CONCLUSIONS: In general, neurosurgeons lacked a controllable online presence within their first page of Google Search results. Third-party physician rating websites constituted about half of the search results, and a relative lack of social media websites was apparent. Still, numerous opportunities exist for neurosurgeons to address this disparity.

House Staff Participation in Patient Safety Reporting: Identification of Predominant Barriers and Implementation of a Pilot Program.

OBJECTIVES: Patient safety event (PSE) reporting is a critical element for healthcare organizations that are striving for continuous quality improvement. Although resident physicians routinely provide the majority of direct patient care, the level of their participation in PSE reporting historically has been low. In addition, as part of the Accreditation Council for Graduate Medical Education's Next Accreditation System, the Clinical Learning Environment Review site visit assesses residents' engagement in PSE reporting at each accredited academic institution. The objective of this study was to understand the common barriers to PSE reporting and design an intervention to increase the number of PSE reports by resident physicians. METHODS: We surveyed 304 residents and fellows to assess attitudes toward the PSE reporting system and identify barriers to submitting online PSE reports. Based on this analysis of barriers, we piloted interventions with the internal medicine residency program and measured their effect on resident PSE reporting. RESULTS: Of the survey respondents, 58% had never submitted a PSE report. The most commonly identified barriers were too much time required to submit a report (38% of all respondents), lack of education on how or what to report (37%), lack of feedback or change after reporting (19%), and concern for repercussions or lack of anonymity (13%). Based on this analysis of barriers, we piloted interventions with the internal medicine residency program to educate residents about PSE reporting through a reminder message in their orientation e-mail, informational slides at the end of conferences that described what and how to report, a pocket card with reporting instructions, and leadership encouragement during walk rounds by chief medical residents and the program director. Compared with the 10 weeks before the start of the intervention, the number of PSE reports submitted by internal medicine residents more than doubled, from 16 to 37 reports (P < 0.01). This increase in resident PSE reporting was sustained for 20 weeks despite the interventions lasting only 8 weeks. CONCLUSIONS: A resident-driven intervention that fostered a culture of encouragement for PSE reporting through leadership support and targeted education increased the number of PSE reports submitted by internal medicine residents at our health system. Hospitals and health systems should seek to understand the common barriers to PSE reporting from this important group of direct patient care providers and administer structured educational programs to encourage their participation.

Gender differences in acute and 30-day outcomes after orbital atherectomy treatment of de novo, severely calcified coronary lesions.

OBJECTIVES: The aim of this analysis is to evaluate potential differences according to gender in terms of acute and 30-day clinical outcomes in patients enrolled in the ORBIT II trial with de novo, severely calcified coronary lesions treated with orbital atherectomy to facilitate stent delivery. BACKGROUND: Previous studies have shown an increased risk of safety events in females compared to males undergoing percutaneous coronary intervention. METHODS: ORBIT II, a prospective, nonrandomized, multicenter, single arm study conducted in the US evaluated the safety and efficacy of the coronary OAS to facilitate stent placement in de novo, severely calcified coronary lesions in 443 subjects (286 males and 157 females). The rate of major adverse cardiac events (MACE) defined as a composite of myocardial infarction, target vessel revascularization, and cardiac death was evaluated in-hospital and 30-days postprocedure. For this analysis, the ORBIT II safety and efficacy results were stratified by gender. RESULTS: At baseline, females were significantly older than males and had a lower mean estimated glomerular filtration rate. Males had a higher rate of previous coronary artery bypass grafting and history of smoking. The rates of successful stent delivery and <50% residual stenosis were similar in males and females. In-hospital and 30-day MACE rates did not differ by gender. CONCLUSIONS: Despite females being older, having smaller arteries, and more renal dysfunction, preparation of severely calcified coronary lesions with orbital atherectomy to facilitate stent deployment results in similar rates of in-hospital and 30-day MACE, irrespective of gender.