Real-world clinical outcomes of patients with stage IIB or IIC cutaneous melanoma treated at US community oncology clinics.

Aim: To describe clinical outcomes after complete surgical resection of stage IIB and IIC melanoma. Methods: Adult patients (n = 567) with stage IIB or IIC cutaneous melanoma initially diagnosed and completely resected from 2008-2017 were identified using data from a US community-based oncology network. Results: Median patient follow-up was 38.8 months from melanoma resection to death, last visit or data cut-off (31 December 2020). For stage IIB (n = 375; 66%), Kaplan-Meier median real-world recurrence-free survival (rwRFS) was 58.6 months (95% CI, 48.6-69.5). For stage IIC (n = 192; 34%), median rwRFS was 29.9 months (24.9-45.5). Overall, 44% of patients had melanoma recurrence or died; 30% developed distant metastases. Conclusion: Melanoma recurrence was common, highlighting the need for effective adjuvant therapy for stage IIB and IIC melanoma.

New treatments are now available that decrease tumor recurrence when administered after surgery to remove melanoma skin tumors that are graded as stage IIB or IIC (i.e., with no cancer spread to the local lymph nodes). We studied 567 'real-world' patients at clinics in the USA who had stage IIB or IIC melanoma tumors removed in 2008­2017, before these new postsurgical treatments were widely available, to evaluate their survival and tumor recurrence. We found that almost half of these patients (44%) had melanoma recurrence or had died, and a third (30%) had tumor spread beyond the original site, by the end of 2020. These findings highlight the need for more effective treatments after surgical removal of stage IIB and IIC melanoma.

Relationships between survival and real-world recurrence-free survival or distant metastasis-free survival among patients with completely resected stage IIB or IIC melanoma.

Long follow-up time is needed for overall survival (OS) data to mature for early-stage melanoma. This retrospective study aimed to describe the relationships between OS and two intermediate endpoints - real-world recurrence-free survival (rwRFS) and real-world distant metastasis-free survival (rwDMFS) - for patients with stage IIB or IIC melanoma that was completely resected from 1 January 2008 to 31 December 2017, with follow-up to 31 December 2020. We used three different approaches to describe the relationships: estimates of correlation using Kendall τ rank correlation; comparisons of all-cause survival with/without recurrence or distant metastasis using adjusted Cox proportional hazard models; and landmark analyses of all-cause survival stratified by recurrence status at 1-5 years. During a 39-month median follow-up from surgical resection, 223/567 patients (39%) experienced recurrence, among whom 171/567 patients (30%) developed distant metastasis. Median OS from surgical resection was 117.6 months [95% confidence interval (CI), 104.7-not reached], median rwRFS was 49.8 months (95% CI, 39.6-61.0), and median rwDMFS was 70.9 months (95% CI, 58.4-89.1). We observed strong correlations between rwRFS and OS, and between rwDMFS and OS (Kendall τ of 0.73 and 0.82, respectively). Risk of death was significantly greater after recurrence (all-cause survival adjusted hazard ratio [HR], 7.48; 95% CI, 4.55-12.29) or distant metastasis (adjusted HR, 11.00; 95% CI, 6.92-17.49). Risk of death remained significantly elevated with recurrence or distant metastasis by landmark years 1, 3, and 5 after surgical resection. These findings support the use of recurrence/rwRFS and distant metastasis/rwDMFS as surrogate endpoints for OS after complete resection of stage IIB or IIC melanoma.

Real-world utilization of immune checkpoint inhibitors in extensive stage small-cell lung cancer in community settings.

Aim: This study examined real-world treatment patterns for extensive-stage small-cell lung cancer (ES-SCLC) after immune checkpoint inhibitors (ICIs) became available for frontline use. Methods: Adult patients with ES-SCLC initiating 1L systemic treatment were identified from electronic health records. Results: Among patients with recurrent/progressive ES-SCLC, the most common treatment classes were platinum-based chemotherapy (81.1% of 228) and ICI monotherapy (35.1% of 191) in 1L and 2L, respectively. Among patients with de novo ES-SCLC, the most common treatment classes were ICI + platinum-based chemotherapy (64.4% of 1268) and other chemotherapy (44.9% of 512) in 1L and 2L, respectively. Among patients who received no ICI in 1L, 62.6%-70.3% received it in 2L and 62.6-68.5% in 3L. Some who received 1L ICI were re-treated with ICI in subsequent lines (14.5-18.8% in 2L, 18.2-50.0% in 3L). Conclusion: Real-world ICI utilization in ES-SCLC, particularly ICI re-challenge, demonstrates high unmet needs in this patient population.

Small-cell lung cancer (SCLC) is a type of lung cancer that is highly lethal. About 70% of patients have advanced SCLC when they first get their diagnosis and most die within 5 years. This study focused on immune checkpoint inhibitors (ICIs), a type of treatments that can help the immune system to fight cancer and has only been approved to treat SCLC in the past 4­5 years. We studied 1496 patients with advanced SCLC treated at community cancer practices in USA between October 2018 and February 2020. Patients averaged about 68 years old when they started treatment. By looking at the types and sequences of treatments, we found that although ICI are often used to treat SCLC, patients with this aggressive cancer still need other effective treatment choices.

Physician networks and potentially inappropriate opioid prescriptions.

Background: Opioid overdose is a national health priority and curbing inappropriate prescribing is critical. In 2016, the Centers for Disease Control and Prevention (CDC) issued appropriate prescribing guidelines.Objectives: Examine associations between care networks defined by shared patients and problematic opioid prescribing.Methods: Analysis was at the provider-year level. Social network analysis (SNA) applied to the Medicaid MarketScan® Research Database for the years 2010-2015 identified care communities, each community's level of integration (centralization), and each provider's integration (centrality). Nested multivariable logistic regressions controlling for patient mix and provider specialty simultaneously examined the risk of any (incident) and repeated (prevalent) inappropriate prescribing.Outcomes: Four behaviors defined by the CDC guidelines were examined: (1) more than 90 days continuous supply of high-dose opioid analgesics for chronic pain, (2) overlapping opioid supplies, (3) overlapping opioid and benzodiazepine prescriptions, and (4) prescribing an extended release opioid for an acute pain diagnosis.Results: Provider centrality was associated with reduced incidence of outcome (2) (OR: 0.95) and decreased prevalence of outcomes (1), (2), and (3). However, higher incidence (OR: 1.32) and prevalence (OR: 1.027) of outcome (4) were observed. Conversely, centralization associated with decreased incidence of (1) and (2) and lower prevalence of (1), (2), and (3).Conclusions: Greater provider integration is associated with a lower risk of a provider's patients repeatedly having potentially inappropriate prescription fills; however, the association with a provider having any potentially problematic prescription is more ambiguous.

Behavioral Health's Integration Within a Care Network and Health Care Utilization.

OBJECTIVE: Examine how behavioral health (BH) integration affects health care costs, emergency department (ED) visits, and inpatient admissions. DATA SOURCES/STUDY SETTING: Truven Health MarketScan Research Databases. STUDY DESIGN: Social network analysis identified "care communities" (providers sharing a high number of patients) and measured BH integration in terms of how connected, or central, BH providers were to other providers in their community. Multivariable generalized linear models adjusting for age, sex, number of prescriptions, and Charlson comorbidity score were used to estimate the relationship between the centrality of BH providers and health care utilization of BH patients. DATA COLLECTION/EXTRACTION METHODS: Used outpatient, inpatient, and pharmacy claims data from six Medicaid plans from 2011 to 2013 to identify study outcomes, comorbidities, providers, and health care encounters. PRINCIPAL FINDINGS: Behavioral health centrality ranged from 0 (no BH providers) to 0.49. Relative to communities at the median BH centrality (0.06), in 2012, BH patients in communities at the 75th percentile of BH centrality (0.31) had 0.2 fewer admissions, 2.1 fewer all-cause ED visits, and accrued $1,947 fewer costs, on average. CONCLUSIONS: Increased behavioral centrality was significantly associated with a reduced number of ED visits, less frequent inpatient admissions, and lower overall health care costs.

The Impact Of Medicare ACOs On Improving Integration And Coordination Of Physical And Behavioral Health Care.

The accountable care organization (ACO) model holds the promise of reducing costs and improving the quality of care by realigning payment incentives to focus on health outcomes instead of service volume. One key to managing the total cost of care is improving care coordination for and treatment of people with behavioral health disorders. We examined qualitative data from ninety organizations participating in Medicare ACO demonstration programs from 2012 through 2015 to determine whether and how they focused on behavioral health care. These ACOs had mixed degrees of engagement in improving behavioral health care for their populations. The biggest challenges included a lack of behavioral health care providers, data availability, and sustainable financing models. Nonetheless, we found substantial interest in integrating behavioral health care into primary care across a majority of the ACOs.

Physician attitudes toward strategies to promote the adoption of medical evidence into clinical practice.

BACKGROUND: [corrected] Promoting the adoption of medical evidence into clinical practice has been advocated as one approach to improving healthcare quality and reducing medical errors. Data describing the effectiveness of different strategies to achieve this goal in real-world settings are limited. OBJECTIVE: To determine the effectiveness of selected interventions on the adoption of medical evidence into clinical practice. STUDY DESIGN: A cross-sectional survey of a random sample of physicians selected from the American Medical Association's Physician Master File. PATIENTS AND METHODS: We examined the perceived effectiveness of 7 strategies (represented by 27 individual interventions) and 5 general approaches for promoting the adoption of medical evidence into clinical practice in 1100 practicing physicians. Respondent exposure to interventions was also determined. Regression analyses were performed to identify factors that affected effectiveness ratings. Analysis of variance was used to test the hypothesis of equal mean scores across different comparison groups. RESULTS: Of 1,100 surveys mailed, 63 (5.7%) were excluded and 431 were completed (response rate = 41.6%). Mean +/- SD effectiveness scores for the 27 individual interventions on a 5-point Likert scale ranged from 2.0 +/- 0.9 (literature received from insurance companies and managed care organizations) to 4.2 +/- 0.8 (one-on-one communication with respected colleagues). Ranges for the 7 strategies were 2.6 +/- 1.0 (patient-mediated interventions) to 3.6 +/- 0.9 (educational meetings) and for the 5 general approaches were 1.98 +/- 0.9 (administrative interventions) to 3.3 +/- 0.8 (provider education). The hypothesis of equal mean effectiveness scores was rejected for all comparisons (P < .001). Frequency of exposure was the only variable to predict effectiveness (P < .001 for all regression models). CONCLUSION: From the perspective of practicing physicians, the frequency of exposure to strategies for promoting the adoption of medical evidence into clinical practice strongly affects their perceived effectiveness.

The limited incorporation of economic analyses in clinical practice guidelines.

BACKGROUND: Because there is increasing concern that economic data are not used in the clinical guideline development process, our objective was to evaluate the extent to which economic analyses are incorporated in guideline development. METHODS: We searched medline and HealthSTAR databases to identify English-language clinical practice guidelines (1996-1999) and economic analyses (1990-1998). Additional guidelines were obtained from The National Guidelines Clearinghouse Internet site available at http://www.guideline.gov. Eligible guidelines met the Institute of Medicine definition and addressed a topic included in an economic analysis. Eligible economic analyses assessed interventions addressed in a guideline and predated the guideline by 1 or more years. Economic analyses were defined as incorporated in guideline development if 1) the economic analysis or the results were mentioned in the text or 2) listed as a reference. The quality of economic analyses was assessed using a structured scoring system. RESULTS: Using guidelines as the unit of analysis, 9 of 35 (26%) incorporated at least 1 economic analysis of above-average quality in the text and 11 of 35 (31%) incorporated at least 1 in the references. Using economic analyses as the unit of analysis, 63 economic analyses of above-average quality had opportunities for incorporation in 198 instances across the 35 guidelines. Economic analyses were incorporated in the text in 13 of 198 instances (7%) and in the references in 18 of 198 instances (9%). CONCLUSIONS: Rigorous economic analyses may be infrequently incorporated in the development of clinical practice guidelines. A systematic approach to guideline development should be used to ensure the consideration of economic analyses so that recommendations from guidelines may impact both the quality of care and the efficient allocation of resources.

Effects of disease management programs on functional status of patients with rheumatoid arthritis.

OBJECTIVE: To perform a systematic review of the published literature on disease management of rheumatoid arthritis (RA) and to use meta-analysis to estimate the magnitude of benefit these programs have on functional status in patients with RA. METHODS: Computerized databases for English articles from 1966 to September 2001 were searched. Two reviewers evaluated 1,029 published titles, identified 11 studies meeting explicit inclusion criteria, and extracted data about study characteristics, interventions used, and outcomes measured. Pooled effect sizes for functional status were calculated using a random-effects model. RESULTS: Four out of 8 disease management programs showed significant improvements in functional status; however, the pooled effect size (ES) was small and statistically non-significant (ES 0.27; 95% confidence interval [95% CI] -0.01, 0.54). Studies with longer intervention durations (>5 weeks) had significantly improved patient functional status (ES 0.49; 95% CI 0.12, 0.86), compared with studies with shorter intervention durations (

The use of rheumatoid arthritis health-related quality of life patient questionnaires in clinical practice: lessons learned.

OBJECTIVE: The utilization of health-related quality of life (HRQOL) patient questionnaires by clinical rheumatologists is limited. Yet, considerable literature exists defining the value of such data. In an effort to understand this apparent paradox, we performed a literature review and conducted a survey to describe what has been learned over the past 2 decades concerning the use of these measures in clinical care and explore the reasons for their underutilization. METHODS: A panel of rheumatologists with extensive clinical experience was convened to review the relevant literature pertaining to the use of HRQOL patient instruments in clinical practice. Additionally, a survey of all American College of Rheumatology practicing clinicians was conducted to assess the use of and beliefs about these measures. RESULTS: The literature provided evidence to support the use of HRQOL patient measures in clinical practice. Forty-seven percent of the responding rheumatologists stated that none of their patients complete HRQOL patient questionnaires. The majority of respondents (63%) reported that such information is "somewhat valuable." The most frequently reported reason for the underutilization was that such instruments "require too much staff time." CONCLUSIONS: The literature supports the potential value of HRQOL patient questionnaires in clinical practice. Few rheumatologists routinely gather such information as part of patient care. Reasons for this discrepancy between utility and use are given along with recommendations intended to help increase their utilization in clinical care.