Real-World Treatment Outcomes, Healthcare Resource Use, and Costs Associated with Antiemetics Among Cancer Patients on Cisplatin-Based Chemotherapy.

INTRODUCTION: Chemotherapy-induced nausea and vomiting (CINV) is a recognized adverse outcome among patients with cancer. This retrospective study aimed to quantify the treatment outcomes, resource utilization, and costs associated with antiemetic use to prevent CINV in a broad US population who received cisplatin-based chemotherapy. METHODS: Data from the STATinMED RWD Insights Database was collected from January 1, 2015 to December 31, 2020. Cohorts included any patients that had at least one claim for fosnetupitant + palonosetron (NEPA) or fosaprepitant + palonosetron (APPA) and evidence of initiating cisplatin-based chemotherapy. Logistic regression was used to evaluate nausea and vomiting visits within 14 days after chemotherapy, and generalized linear models were used to examine all-cause and CINV-related healthcare resource utilization (HCRU) and costs. RESULTS: NEPA was associated with significantly lower rates of nausea and vomiting visits after chemotherapy (p = 0.0001), including 86% greater odds of nausea and vomiting events for APPA during the second week after chemotherapy (odds ratio [OR] = 1.86; p = 0.0003). The mean numbers of all-cause inpatient visits (p = 0.0195) and CINV-related inpatient and outpatient visits were lower among NEPA patients (p < 0.0001). These differences corresponded to 57% of NEPA patients and 67% of APPA patients having one or more inpatient visits (p = 0.0002). All-cause outpatient costs and CINV-related inpatient costs were also significantly lower for NEPA (p < 0.0001). The mean number of all-cause outpatient visits, all-cause inpatient costs, and CINV-related outpatient costs was not significantly different between groups (p > 0.05). CONCLUSION: In this retrospective study based on claims data, NEPA was associated with lower rates of nausea and vomiting and lower CINV-related HCRU and costs compared to APPA following cisplatin-based chemotherapy. These results complement clinical trial data and published economic models supporting the use of NEPA as a safe, effective, and cost-saving antiemetic for patients undergoing chemotherapy.

Antiemetic use and chemotherapy induced nausea and vomiting related hospitalization costs after highly or moderately emetogenic chemotherapy.

Aim: Despite numerous available antiemetics, chemotherapy induced nausea and vomiting (CINV) still affects many patients, and CINV related hospitalizations and costs often result. Materials & methods: PrecisionQ analyzed its database to evaluate CINV related hospitalizations and costs following antiemetics use including netupitant/fosnetupitant with palonosetron (NEPA), aprepitant/fosaprepitant with ondansetron (APON) or aprepitant/fosaprepitant with palonosetron (APPA) in patients receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy. Results: Database analysis identified 15,583 patient records (807 NEPA, 2023 APON, 12,753 APPA) and mean CINV related hospitalization costs were lower across all patients receiving NEPA (US$301) compared with patients receiving APON ($1006, p < 0.0001) or APPA ($321, p < 0.0001). Conclusion: NEPA is associated with lower CINV related hospitalization costs compared with APON and APPA among patients receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy.

Chemotherapy patients often experience nausea and vomiting that not only has a negative impact on the patient's quality of life but can also result in unplanned hospitalizations with high associated costs. Numerous medications and specific guidelines are available to prevent nausea and vomiting in patients with cancer. Specifically, the combination of two classes of medications (serotonin inhibitors + neurokinin type 1 inhibitors) has been shown to provide the greatest benefit. However, hospitalizations due to nausea and vomiting still occur, and providers require further information to determine the best options for their patients. In this study, the combination of netupitant/fosnetupitant with palonosetron resulted in lower hospitalization costs compared with aprepitant/fosaprepitant with ondansetron or aprepitant/fosaprepitant with palonosetron in chemotherapy patients.

Maintenance and Concomitant Therapy Use with Chlormethine Gel Among Patients with Stage IA/IB Mycosis Fungoides-Type Cutaneous T-Cell Lymphoma (MF-CTCL): A Real-World Evidence Study.

INTRODUCTION: Chlormethine (CL) gel is a skin-directed therapy approved for treatment of stage IA/IB mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) in the USA. MF-CTCL has a chronic clinical course, requiring long-term maintenance therapy with one or more therapies. This analysis describes real-world patterns of maintenance therapy and use of concomitant therapy with CL gel among patients with stage IA/IB MF-CTCL. METHODS: In a US-based registry, MF-CTCL patients treated with CL gel were enrolled between 3/2015 and 10/2018 across 46 centers and followed for up to 2 years. Patient demographics, clinical characteristics, CL gel treatment patterns, concomitant treatments, clinical response, and adverse events (AEs) were collected from medical records. Descriptive statistics are reported. RESULTS: Of the 206 patients with stage IA/IB MF-CTCL, 58.7% were male, and average age was 60.7 years with 4.6 years since diagnosis. Topical steroids, phototherapy, and topical retinoids were used concomitantly with CL gel in 62.6%, 26.2%, and 6.3% of patients, respectively. Most concomitant therapies (up to 85%) were started before CL gel initiation and, in about half of the cases (up to 57%), were used concurrently for ≥ 12 months. Overall, 158 (76.7%) patients experienced partial response (PR) and 144 continued with maintenance therapy. After achieving PR, most patients (74.3%) kept the same maintenance therapy schedule, most commonly once daily. Of patients who had any skin-related AE (31.6%) or skin-related AEs associated with CL gel (28.2%), nearly half experienced CL gel treatment interruption and ~40% had a dosing reduction. The observed real-world treatment patterns were concordant with National Comprehensive Cancer Network (NCCN) guidelines. CONCLUSION: The study results suggest that continuing CL gel maintenance therapy and combining treatments with CL gel are common practice in the real-world setting, with most maintained on a stable dosing schedule. Careful management of AEs may help patients maintain long-term optimal dosing with less treatment interruptions and dosing reductions.

Association Between Bio-Fermentation Derived Hyaluronic Acid and Healthcare Costs Following Knee Arthroplasty.

Background: Limiting access to intra-articular knee injections, including hyaluronic acid (HA), has been advocated as a cost-containment measure in the treatment of knee osteoarthritis. The association between presurgical injections and post-surgical complications such as early periprosthetic joint infection and revision remained to be investigated. This study evaluated pre- and post-surgical costs and rates of post-surgical complications in knee arthroplasty (KA) patients with or without prior HA use. Methods: Commercial and Medicare Supplemental Claims Data (IBM MarketScan Research Databases) from January 1, 2012 to December 31, 2018 were used to identify unilateral KA patients. Those who completed a course of bio-fermentation derived HA (Bio-HA) as the first-line HA therapy comprised of the test group (n = 4091), while the control group did not use HA prior to KA (n = 118,659). Using multivariable regression with propensity score (PS) weighting, overall healthcare costs, readmission rates, and revision rates were assessed at six months following KA. Results: Healthcare costs following KA were significantly lower for the Bio-HA group ($10,021 ± $22,796) than No HA group ($12,724 ± $32,966; PS p < 0.001). Bio-HA patients had lower readmission rates (8.9% vs 14.0%; PS p < 0.001) and inpatient costs per readmitted patient ($43,846 ± $50,648 vs $50,533 ± $66,150; PS p = 0.005). There were no differences in revision rate for any reason (Bio-HA: 0.78% vs No HA: 0.67%; PS p = 0.361) and with PJI (Bio-HA: 0.42% vs No HA: 0.33%; PS p = 0.192). Costs in the six months up to and including the KA were similar for both groups (Bio-HA: $49,759 ± $40,363 vs No HA: $50,532 ± $43,183; PS p = 0.293). Conclusion: Bio-HA use prior to knee arthroplasty did not appear to increase overall healthcare costs in the six months before and after surgery. Allowing access to HA injections provides a non-surgical therapeutic option without increasing cost or risk of post-surgical complications.

Clinical complications in patients with primary and recurrent Clostridioides difficile infection: A real-world data analysis.

OBJECTIVE: Clostridioides difficile infection and recurrent C. difficile infection result in substantial economic burden and healthcare resource use. Sepsis and bowel surgery are known to be serious complications of C. difficile infection. This study evaluated clinical complications in patients with C. difficile infection and recurrent C. difficile infection during a 12-month period following the primary C. difficile infection. METHODS: A retrospective analysis of commercial claims data from the IQVIA PharMetrics Plus™ database was conducted for patients aged 18-64 years with an index C. difficile infection episode requiring inpatient stay or an outpatient visit for C. difficile infection followed by a C. difficile infection treatment. Each C. difficile infection episode ended after a 14-day C. difficile infection-claim-free period was observed. Recurrent C. difficile infection was defined as a further C. difficile infection episode within an 8-week window following the claim-free period. Clinical complications were documented over 12 months of follow-up and stratified by the number of recurrent C. difficile infection episodes (0 rCDI, 1 rCDI, 2 rCDI, and 3+ rCDI). RESULTS: In total, 46,571 patients with index C. difficile infection episode were included. During the 6-month pre-index, the mean (standard deviation) baseline Charlson comorbidity index score, by increasing the recurrent C. difficile infection group, was 1.2 (1.9), 1.5 (2.2), 1.8 (2.3), and 2.3 (2.5). During the 12-month follow-up, sepsis occurred in 16.5%, 27.3%, 33.1%, and 43.3% of patients, and subtotal colectomy or diverting loop ileostomy was performed in 4.6%, 7.3%, 8.9%, and 10.5% of patients, respectively, by increasing the recurrent C. difficile infection group. CONCLUSIONS: Reduction in recurrent C. difficile infection is an important step to reduce the burden of serious clinical complications, and new treatments are needed to reduce C. difficile infection recurrence.

Predictors of High-cost Patients With Noninfectious Inflammatory Eye Diseases.

PURPOSE: Noninfectious inflammatory eye diseases (NIIEDs), such as uveitis, is a general term used to describe a complex mix of acute, chronic, allergic, and inflammatory disorders. Prior literature has established that, in addition to severe clinical burden, NIIEDs is associated with significant economic burden for US payers; however, no literature provides a current estimate of the economic burden associated with patients with high-cost NIIEDs. This study aimed to better understand the cost and resource use distribution and predictors of patients with high-cost NIIEDs. METHODS: This retrospective cohort study selected adult patients with NIIEDs from a large US administrative claims database between 2006 and 2015. Among the included patients, total all-cause health care costs were calculated for a randomly selected 12-month period. Patients in the top 20% of total all-cause health care costs were identified as high-cost patients; the remaining patients were identified as lower-cost patients. Patient demographic characteristics, clinical characteristics, cost, and health care resource utilization (HRU) were compared. Logistic regression models were used to determine characteristics associated with high-cost patients. FINDINGS: Patients with NIIEDs (n = 14,879) were categorized into 2976 high-cost and 11,903 lower-cost patients. High-cost patients with NIIEDs were significantly more likely to experience blindness, cataract, cystoid macular degeneration, retinal detachment, and visual disturbances during the follow-up period than the lower-cost patients (all P < 0.05). The high-cost patients accounted for ~77% of the total all-cause health care spend. High-cost patients incurred an average annual total health care cost of $59,873, and the top 1 percentile incurred $349,967 during the follow-up period. Hospitalization was a key cost driver among the high-cost patients, accounting for 50% of the total cost among the top 1 percentile of patients. High-cost patients were more likely to have specific autoimmune diseases, inpatient admission, and use of biologic and immunosuppressant agents. IMPLICATIONS: A small segment of patients with NIIEDs consumed most resources. This study identified several predictors based on patient characteristics and HRU that may help inform the profile of patients with NIIEDs with the highest health care needs. As such, patients with a given profile can be selected for targeted interventions by clinicians to potentially help improve quality of care and to reduce costs.

Duration of anticoagulant therapy and VTE recurrence in patients with cancer.

PURPOSE: Anticoagulant therapy for at least 3-6 months is currently recommended for treatment of venous thromboembolism (VTE) in patients with cancer, but the optimal duration of treatment is unknown. This study examines the association between the duration of anticoagulation treatment and VTE recurrence in cancer patients. METHODS: The Humana claims database was used to identify newly diagnosed cancer patients who had their first VTE diagnosis between January 1, 2013, and May 31, 2015, and initiated injectable or oral anticoagulant therapy. Follow-up was calculated from the index treatment initiation to the end of eligibility or end of data (June 2015). VTE recurrence was defined as a hospitalization with a primary diagnosis of VTE. Cox proportional hazards models were used to evaluate the risk of VTE recurrence by duration of therapy in patients who discontinued therapy. RESULTS: The study included 1158 patients. Compared to patients treated for 0 to 3 months, VTE recurrences were significantly lower among patients treated for 3 to 6, or over 6 months. After adjustment for baseline characteristics, patients treated for 3 to 6 months (HR [95%CI], 0.53; 0.37-0.76) and more than 6 months (HR [95%CI], 0.48; 0.34-0.68) were still significantly less likely to have VTE recurrences compared to patients treated for 0 to 3 months (both p < 0.01). Findings were similar using a VTE event definition that included outpatient visits. CONCLUSIONS: Among newly diagnosed cancer patients with VTE, anticoagulant therapy lasting more than 3 months was associated with a lower risk of VTE recurrence.

Effectiveness and safety of anticoagulants for the treatment of venous thromboembolism in patients with cancer.

Anticoagulation is used to treat venous thromboembolism (VTE) in cancer patients, but may be associated with an increased risk of bleeding. VTE recurrence and major bleeding were assessed in cancer patients treated for VTE with the most currently prescribed anticoagulants in clinical practice. Newly diagnosed cancer patients (first VTE 1/1/2013-05/31/2015) who initiated rivaroxaban, low-molecular-weight heparin (LMWH), or warfarin were identified from Humana claims data and observed until end of eligibility or end of data availability. VTE recurrence was a hospitalization with a primary diagnosis of VTE ≥7 days after first VTE. Major bleeding events on treatment were identified using validated criteria. Cohorts were compared using Kaplan-Meier rates at 6 and 12 months and Cox proportional hazards models. Cohorts were adjusted for their differences at baseline. A total of 2428 patients (rivaroxaban: 707; LMWH: 660; warfarin: 1061) met inclusion criteria. Patient characteristics were well balanced after weighting. There was a trend for lower VTE recurrence rates in rivaroxaban users compared to LMWH users at 6 months (13.2% vs. 17.1%; P = .060) and significantly lower at 12 months (16.5% vs. 22.2%; P = .030) [HR: 0.72, 95% CI: (0.52-0.95); P = .024]. VTE recurrence rates were also lower for rivaroxaban than warfarin users at 6 months (13.2% vs. 17.5%; P = .014) and 12 months (15.7% vs. 19.9%; P = .017) [HR: 0.74, 95% CI: (0.56-0.96); P = .028]. Major bleeding rates were similar across cohorts. This real-world analysis suggests cancer patients with VTE treated with rivaroxaban had significantly lower risk of recurrent VTE and similar risk of bleeding compared to those treated with LMWH or warfarin.

High-Cost Sarcoidosis Patients in the United States: Patient Characteristics and Patterns of Health Care Resource Utilization.

BACKGROUND: Sarcoidosis is a multisystem inflammatory disorder characterized by the presence of noncaseating granulomas in involved organs. Prior research has found that sarcoidosis imposes a significant economic burden to U.S. payers. However, the drivers of high health care costs among sarcoidosis patients are unknown. OBJECTIVE: To characterize sarcoidosis patients who were among the top 20% of total health care costs. METHODS: Patients with a first diagnosis of sarcoidosis between January 1, 1998, and March 31, 2015 (index date) were selected from a deidentified privately insured administrative claims database. Study patients must have at least 12 months of continuous health plan enrollment prior to the index date. High-cost patients were those in the top 20% of total health care costs during the 12 months following the index date (follow-up period), and the remaining patients were classified as lower-cost patients. Patient characteristics, comorbidities, health care resource use, and health care costs in the study period were compared between the high-cost and lower-cost patients. Multiple logistic regression was used to assess the relationship between patient characteristics and being a high-cost sarcoidosis patient. RESULTS: A total of 7,173 sarcoidosis patients met the selection criteria. The 20% of patients classified as high-cost patients accounted for approximately 72% of the total health care costs in the 12-month follow-up period. Compared with lower-cost patients, high-cost patients were slightly older (50.6 vs. 49.1 years) and had a higher comorbidity burden at baseline (Charlson Comorbidity Index = 1.8 vs. 0.7). Mean annual total health care cost for high-cost sarcoidosis patients was 10 times that of their lower-cost counterparts ($73,345 vs. $7,073). Mean annual health care cost was $119,878 for patients in the 95th-99th percentile and $375,436 for patients in the top 1% of spend. High-cost patients had greater medical resource use and costs across all places of service (i.e., inpatient, emergency department, outpatient, and other) compared with lower-cost patients. Findings showed that higher total health care cost resulted in a larger proportion of inpatient spend and a smaller proportion of outpatient and pharmacy spend. Adjusting for baseline characteristics, high-cost patients were associated with a number of factors with high ORs: the presence of comorbidities such as deficiency anemia (OR = 1.606; P < 0.001), depression (OR = 1.504; P < 0.001), or cardiac arrhythmia (OR = 1.493; P < 0.001); having an inpatient admission (OR = 9.771; P < 0.001); and use of biologic therapies adalimumab and/or infliximab (OR = 31.821; P < 0.001). CONCLUSIONS: This study described the characteristics of high-cost sarcoidosis patients and identified several high-cost indicators using contemporary administrative data. The health care cost distribution for sarcoidosis patients is highly skewed, making it a worthwhile endeavor to focus improvement efforts on patients in the top quintile. The study findings can help population health decision makers identify a subset of patients for targeted interventions aimed at improving quality of care and reducing overall costs. DISCLOSURES: This study was funded by Mallinckrodt Pharmaceuticals. Rice, White, and Lopez are employees of Analysis Group, which received funding from Mallinckrodt Pharmaceuticals to conduct this research. Nelson is an employee of Mallinckrodt Pharmaceuticals. Study concept and design were contributed by Rice, White, and Nelson, along with Lopez. Lopez took the lead in data collection, with assistance from Rice and White. Data interpretation was performed by all of the authors. The manuscript was written by Rice, Lopez, White, and Nelson and revised by Rice, along with White and Nelson.

A Retrospective Medical Record Review of Utilization Patterns and Medical Resource Use Associated with Repository Corticotropin Injection among Patients with Rheumatologic Diseases in the United States.

INTRODUCTION: Repository corticotropin injection (RCI) has anti-inflammatory and immune-modulatory effects and is approved for multiple indications, including several rheumatologic conditions. The aims of this nationally representative, retrospective, observational study were to describe patient characteristics, RCI treatment patterns, and barriers to RCI use in patients with rheumatologic disease, and to compare medical resource use (MRU) before and after RCI therapy. METHODS: A random sample of US physicians was recruited to abstract the medical records of deidentified patients with a diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA), dermatomyositis/polymyositis (DM/PM), or systemic lupus erythematosus (SLE) who had been treated with RCI in the previous 24 months. Patient characteristics and patterns of RCI use were identified. Mean MRU in the 3 months before and after RCI therapy was compared using paired-samples t tests. RESULTS: A total of 449 physicians abstracted the medical records of 217 RA, 190 PsA, 254 DM/PM, and 95 SLE patients. In all groups combined, patients had received a mean of 3.3 treatment medications before initiating RCI. Most patients (75%-94%) were receiving RCI for the first time, indicating that repeated courses of RCI were uncommon. RCI was used as bridge therapy in 18% of patients. Approximately 24% of patients encountered an obstacle in accessing RCI, primarily insurance-related. After RCI therapy, the number of hospitalizations and hospital days were significantly reduced for all cohorts (all P < 0.05), and the number of outpatient visits was significantly lower for all cohorts (P < 0.05) except the SLE cohort (P = 0.3230). Study limitations include potentially incomplete data in the medical records and a relatively short duration for capturing MRU changes. CONCLUSIONS: RCI was used primarily as late-line therapy in patients with rheumatologic diseases. Medical resource use was significantly lower in the 3 months after therapy compared with 3 months prior. This finding suggests that RCI may improve disease control and warrants further evaluation. FUNDING: Mallinckrodt Pharmaceuticals.

Economic burden of sarcoidosis in a commercially-insured population in the United States.

BACKGROUND: Sarcoidosis is a multi-system inflammatory disorder characterized by the presence of non-caseating granulomas in involved organs. Patients with sarcoidosis have a reduced quality-of-life and are at an increased risk for several comorbidities. Little is known about the direct and indirect cost of sarcoidosis following the initial diagnosis. AIMS: To provide an estimate of the healthcare resource utilization (HCRU) and costs borne by commercial payers for sarcoidosis patients in the US. METHODS: Patients with a first diagnosis of sarcoidosis between January 1, 1998 and March 31, 2015 ("index date") were selected from a de-identified privately-insured administrative claims database. Sarcoidosis patients were required to have continuous health plan enrollment 12 months prior to and following their index dates. Propensity-score (1:1) matching of sarcoidosis patients with non-sarcoidosis controls was carried out based on a logistic regression of baseline characteristics. Burden of HCRU and work loss (disability days and medically-related absenteeism) were compared between the matched groups over the 12-month period following the index date ("outcome period"). RESULTS: A total of 7,119 sarcoidosis patients who met the selection criteria were matched with a control. Overall, commercial payers incurred $19,714 in mean total annual healthcare costs per sarcoidosis patient. The principle cost drivers were outpatient visits ($9,050 2015 USD, 46%) and inpatient admissions ($6,398, 32%). Relative to controls, sarcoidosis patients had $5,190 (36%) higher total healthcare costs ($19,714 vs $14,524; p < 0.001). Sarcoidosis patients also had significantly more work loss days (15.9 vs 11.3; p < 0.001) and work loss costs ($3,288 vs $2,527; p < 0.001) than matched controls. Sarcoidosis imposes an estimated total direct medical cost of $1.3-$8.7 billion to commercial payers, and an indirect cost of $0.2-$1.5 billion to commercial payers in work loss. CONCLUSIONS: Sarcoidosis imposes a significant economic burden to payers in the first year following diagnosis.

Current practice patterns and patient persistence with anticoagulant treatments for cancer-associated thrombosis.

BACKGROUND: Recommended therapeutic options for the management of venous thromboembolism (VTE) in patients with cancer are burdensome, and compliance with guidelines is unknown. OBJECTIVES: To describe current treatment patterns and to evaluate patient persistence on various anticoagulants. PATIENTS/METHODS: Medical and pharmacy claims from the Humana Database were analyzed (01/2007-12/2014). Newly diagnosed cancer patients treated with anticoagulants were categorized into one of the following cohorts: low-molecular-weight heparin (LMWH), warfarin, and rivaroxaban. Discontinuation, switching, and persistence with the index therapy were analyzed. RESULTS: A total of 2941 newly diagnosed patients with cancer who developed VTE and received anticoagulation in outpatient settings were identified. Of these, 97% initiated anticoagulation with LMWH (n=735; 25%), warfarin (n=1403; 47.7%), or rivaroxaban (n=709; 24.1%). Median treatment durations for the LMWH, warfarin, and rivaroxaban cohorts were 3.3, 7.9, and 7.9 months, respectively; Kaplan-Meier rates of persistence to the initial therapy were 37%, 61%, and 61% at 6 months. Warfarin and rivaroxaban users were significantly more likely to remain on initial therapy compared to LMWH (adjusted hazard ratios [HRs; 95% CI]: warfarin, 0.33 [0.28-0.38]; rivaroxaban, 0.38 [0.32-0.46]). The proportion of patients that switched from their initial treatment to another anticoagulation treatment was 22.9%, 7.9%, and 4.7% in the LMWH, warfarin, and rivaroxaban cohorts, respectively. CONCLUSIONS: This real-world analysis showed that, despite guideline recommendations, warfarin and rivaroxaban are at least as equally utilized as LMWH for the treatment of cancer-associated thrombosis. LMWH was associated with significantly lower persistence, shorter duration of treatment, and more switching than warfarin and rivaroxaban.

Evaluation of US prescription patterns: Are treatment guidelines for cancer-associated venous thromboembolism being followed?

INTRODUCTION: Venous thromboembolism (VTE) is a common complication of cancer. Clinical practice guidelines recommend low-molecular-weight heparin (LMWH) for treatment of cancer-associated VTE, but it is unclear how frequently these are followed. This study assessed anticoagulation treatment patterns for VTE in newly diagnosed cancer patients in the United States. MATERIALS AND METHODS: MarketScan® claims records of more than 80 million insured members between January 1, 2009 and July 31, 2014 were retrospectively analyzed. Subjects were included if they were 18years of age or older, and had a diagnosis of cancer (9 solid tumor types) and VTE. Data were included for LMWH, warfarin, and other anticoagulants (fondaparinux and direct oral anticoagulants [DOACs]). Patients with anticoagulant treatment prior to cancer diagnosis were excluded. RESULTS: VTE developed in 6.2% of cancer patients (median, 181days after cancer diagnosis). VTE rates were highest for pancreatic (17.5%) and lung (12.6%) cancer and lowest for breast (4.2%) and prostate (4.1%) cancer. For patients for whom outpatient prescription data were available, warfarin was most commonly used (50.0%), followed by LMWH (40.0%) and other anticoagulants (10.0%). Over 6months, 13% of patients who initiated injectable anticoagulants remained on them compared with 30% of those who initiated oral anticoagulants. More patients switched from LMWH to warfarin and other anticoagulants (44%) versus those who switched from warfarin (28%). CONCLUSIONS: Warfarin was the most utilized anticoagulant for cancer-associated VTE despite guideline recommendations for LMWH. More patients remained on oral versus injectable agents, which may be related to self-injection burden and costs.

Burden of comorbidities among patients with atrial fibrillation.

OBJECTIVE: This study examined comorbidity prevalence and general medication use among individuals with atrial fibrillation in the United States to convey a more comprehensive picture of their total disease burden. METHODS: This was a retrospective, observational evaluation of responses to the 2009 wave of the annual Internet-based National Health and Wellness survey, which collects health data including epidemiologic data and information on medical treatment from a representative nationwide sample of adults in the United States. Responses were assessed to determine three measures of comorbidity: mean number of comorbidities, CHADS2 score reflecting stroke risk (0-6 points; low risk: 0; moderate risk: 1; high risk: ≥ 2), and scores on the Charlson Comorbidity Index, which is a measure of general comorbidity reflecting presence of a wide range of comorbidities. RESULTS: Of the overall sample, 1297 participants reported having been diagnosed with atrial fibrillation. Almost all (98%) of the predominantly male (65.1%) and older (≥ 65 years of age, 65.7%) population with atrial fibrillation had at least one additional comorbidity, and 90% had cardiovascular comorbidities. On the Charlson Comorbidity Index, 44.9% of the respondents had scores of 1-2 and 20.5% had scores of 3 or higher. High risk for stroke, demonstrated by a CHADS2 score of at least 2, was present in 45% and moderate risk (CHADS2 score 1) in 36%. Of the respondents with atrial fibrillation, 71% reported current use of medication to manage the condition, but only 48% of individuals at high risk for stroke reported use of anticoagulation therapy. Of those who reported having common risk factors for stroke, the majority reported receiving prescription therapy for these conditions. CONCLUSIONS: The health burden carried by patients often extends far beyond atrial fibrillation. Physicians should carefully consider comorbidities and concomitant medications when managing patients with atrial fibrillation.

Physical therapists' perceptions of ease of care in patients receiving 2 forms of analgesia after total hip arthroplasty.

BACKGROUND: Pain management modalities that facilitate patient mobility may contribute to recovery after total hip replacement (THR) surgery. OBJECTIVE: The aim of this study was to evaluate the impact of morphine intravenous (IV) patient-controlled analgesia (PCA) and the fentanyl iontophoretic transdermal system (fentanyl ITS) on physical therapists' ability to complete care tasks for patients after THR. DESIGN: The data were from an open-label, randomized, multicenter, active-control phase IIIb clinical trial. METHODS: The settings were 52 US-based teaching and community hospitals. The patients were >or=18 years of age (mean [SEM]: 62.8 [0.6] years in the fentanyl ITS group and 62.9 [0.6] years in the morphine IV PCA group); had an American Society of Anesthesiologists physical status of I, II, or III; and were scheduled to undergo primary unilateral THR surgery. The patients were randomized to receive analgesia for up to 72 hours via the fentanyl ITS (40 microg of fentanyl over 10 minutes for up to 6 doses per hour for 24 hours or 80 doses per system, whichever occurred first) or morphine IV PCA (1-mg bolus doses [with a 5-minute lockout interval between doses] for up to 10 doses per hour for 24 hours). All patients received the usual treatment administered by physical therapists. After each therapy session, physical therapists completed a validated Physical Therapist Ease-of-Care Questionnaire, which included time efficiency and convenience subscales (lower scores indicated more positive responses) and a satisfaction subscale (a higher score indicated a more positive response). Therapists whose average scores were or=4 on both items of the satisfaction subscale were considered responders. RESULTS: Higher percentages of physical therapists were responders for the fentanyl ITS than for morphine IV PCA on the subscales that assessed time efficiency (84.9% and 59.1%, respectively), convenience (86.6% and 71.2%, respectively), and satisfaction (54.3% and 30.5%, respectively). Higher percentages of physical therapists favored the fentanyl ITS than favored morphine IV PCA. Limitations The trial was limited by its open-label design, and physical therapists were more familiar with IV PCA than with the fentanyl ITS. CONCLUSIONS: The findings demonstrate benefits to physical therapists of using the fentanyl ITS over morphine IV PCA in terms of time efficiency, convenience, and satisfaction.

Development and validation of a new instrument to evaluate the ease of use of patient-controlled analgesic modalities for postoperative patients.

OBJECTIVE: To describe the development and psychometric evaluation of a questionnaire assessing the ease of use that patients associate with patient-controlled analgesia (PCA) modalities. METHODS: Qualitative interviews were conducted with patients who had experience with intravenous (IV) PCA for postoperative pain management to generate items relevant to the ease of using PCA modalities. The content validity of the resulting questionnaire was examined through follow-up patient interviews, and an expert panel reviewed the questionnaire. Cognitive debriefing interviews were conducted with patients to determine the clarity and content of the instructions, items, and response scales, and the ease of completing the instrument. Psychometric evaluation was performed with patients who had undergone surgery and received IV PCA for postoperative pain management. Item and scale quality and the internal consistency reliability of the questionnaire were assessed. Construct validity was evaluated by examining the relationship between subscales of the questionnaire with patient-reported outcome measures. Known-groups validity was determined by assessing the instrument's ability to differentiate between patients with versus without an IV PCA problem. A potential limitation of this study was the exclusive sampling of patients who had experience with IV PCA. RESULTS: The Patient Ease-of-Care (EOC) Questionnaire included 23 items in the following subscales: Confidence with Device, Comfort with Device, Movement, Dosing Confidence, Pain Control, Knowledge/Understanding, and Satisfaction. Coefficient alpha reliability estimates were ≥ 0.66 for Overall EOC (includes all subscales except Satisfaction) and all EOC subscales. Construct validity was supported by the moderate relationship between the Pain Control subscale and measures of pain severity and pain interference; additional evidence of construct validity was provided by correlations of the Confidence with Device subscale, the Satisfaction subscale, and Overall EOC with measures of pain severity, pain interference, and satisfaction. Significant mean score differences were reported between participants with and without IV PCA problems for Overall EOC and for the Comfort with Device, Confidence with Device, Movement, Pain Control, and Satisfaction subscales indicating known-groups validity. CONCLUSIONS: Results provide evidence for the reliability and validity of the Patient EOC Questionnaire as a measure of the ease of use that patients associate with PCA systems and may be useful for evaluating emerging PCA modalities.

Patients' assessment of the convenience of fentanyl HCl iontophoretic transdermal system (ITS) versus morphine intravenous patient-controlled analgesia (IV PCA) in the management of postoperative pain after major surgery.

The patient-controlled fentanyl HCl iontophoretic transdermal system (ITS) is a compact, self-contained, needle-free system that has been approved for acute postoperative pain management in hospitalized adults. The objective of the present analysis was to evaluate patients' assessment of fentanyl ITS and morphine intravenous patient-controlled analgesia (IV PCA) convenience on 7 different subscales, using a validated patient ease of care (EOC) questionnaire in 2 prospective, open-label, randomized, phase IIIb clinical trials. Patients received fentanyl ITS or morphine IV PCA (N = 1,305) for up to 72 h after total hip replacement surgery (THR study) or abdominal or pelvic surgery (APS study). For the majority of items on the patient EOC questionnaire, trends suggest that greater percentages of patients reported the most positive response for fentanyl ITS than they did for morphine IV PCA in both studies; differences were particularly noteworthy for items on the Movement subscale. In the THR study, more patients in the fentanyl ITS group were responders compared with those in the morphine IV PCA group for the subscales Confidence with Device, Pain Control, Knowledge/Understanding, and Satisfaction. In the APS study, responder rates for these subscales did not differ between treatment groups. These findings indicate that patients assessed the EOC associated with fentanyl ITS higher compared with morphine IV PCA for the management of acute postoperative pain and suggest that fentanyl ITS has the potential to improve acute postoperative pain care for patients and nurses.

System-related events and analgesic gaps during postoperative pain management with the fentanyl iontophoretic transdermal system and morphine intravenous patient-controlled analgesia.

BACKGROUND: Analgesic gaps (interruptions in analgesic delivery) contribute to ineffective postoperative pain management. In this analysis, we evaluated the incidence of analgesic gaps resulting from system-related events (SREs) for patients using the fentanyl iontophoretic transdermal system (ITS), a noninvasive patient-controlled analgesia (PCA) system, or morphine IV PCA for postoperative pain management. METHODS: Data were pooled from two open-label, randomized, active-controlled trials that evaluated the efficacy and safety of fentanyl ITS and morphine IV PCA after total hip replacement, abdominal, or pelvic surgery. The incidence and duration of analgesic gaps resulting from SREs were assessed, along with SRE resolution times. RESULTS: A total of 1305 patients received fentanyl ITS (n = 647) or morphine IV PCA (n = 658). Fentanyl ITS was associated with a significantly lower incidence of analgesic gaps per 100 patients compared with morphine IV PCA (5.87 vs 12.01, respectively; P < 0.001). Compared with patients receiving morphine IV PCA, patients receiving fentanyl ITS had both a numerically lower median total analgesic gap time (15.0 min vs 20.0 min) and a numerically lower median total SRE resolution time (11.0 min vs 20.0 min). Most fentanyl ITS SREs were resolved by applying a new system, whereas many different SRE resolution methods were used for morphine IV PCA. CONCLUSIONS: Fentanyl ITS was associated with a significantly lower incidence of analgesic gaps relative to morphine IV PCA. Fentanyl ITS may provide patients with fewer interruptions and more continuous analgesic delivery.

Pain management in the last six months of life among women who died of ovarian cancer.

Previous studies indicate that the symptoms of many dying cancer patients are undertreated and many suffer unnecessary pain. We obtained data retrospectively from three large health maintenance organizations, and examined the analgesic drug therapies received in the last six months of life by women who died of ovarian cancer between 1995 and 2000. Subjects were identified through cancer registries and administrative data. Outpatient medications used during the final six months of life were obtained from pharmacy databases. Pain information was obtained from medical charts. We categorized each medication based on the World Health Organization classification for pain management (mild, moderate, or intense). Of the 421 women, only 64 (15%) had no mention of pain in their charts. The use of medications typically prescribed for moderate to severe pain ("high intensity" drugs) increased as women approached death. At 5-6 months before death, 55% of women were either on no pain medication or medication generally used for mild pain; only 9% were using the highest intensity regimen. The percentage on the highest intensity regimen (drugs generally used for severe pain) increased to 22% at 3-4 months before death and 54% at 1-2 months. Older women (70 or older) were less likely to be prescribed the highest intensity medication than those under age 70 (44% vs. 70%, P<0.001). No differences were found in the use of the high intensity drugs by race, marital status, year of diagnosis, stage of disease, or comorbidity. Our finding that only 54% of women with pain were given high intensity medication near death indicates room for improvement in the care of ovarian cancer patients at the end of life.