Metacognitive Reflection and Insight Therapy (MERIT) Delivered Virtually During the COVID-19 Pandemic: An Illustration of Two Cases.

Alternative platform offerings for psychotherapy have become a necessity in the age of the novel coronavirus (COVID-19) pandemic. The current study describes the virtual adaptation of Metacognitive Reflection and Insight Therapy (MERIT) for people with psychosis. MERIT is a recovery-oriented psychotherapy that has shown promise in increasing metacognition and allowing individuals to make meaning of their psychiatric challenges and direct their own recovery efforts. MERIT delivery requires the assumption that metacognitive reflection is an intersubjective act where individuals make meaning with others instead of in isolation. As such, considering the current COVID-19 pandemic, research is needed to understand how intersubjectivity and the therapeutic alliance may differ in a virtual environment rather than in-person. The present study addresses this question by illustrating two case examples of MERIT's adaptation to a virtual delivery telehealth format. Moreover, this study expands on Lysaker and colleagues' (2020) investigation of virtual adaptations of MERIT by exploring how MERIT is adapted in a virtual environment, how intersubjectivity changes in a virtual environment, and, what opportunities virtual platforms allow for metacognitive reflection. Overall, we found that MERIT can be successfully delivered in a virtual telehealth platform. We discuss opportunities and considerations for MERIT and other psychotherapy virtual delivery.

Proactive, Recovery-Oriented Treatment Navigation to Engage Racially Diverse Veterans in Mental Healthcare (PARTNER-MH), a Peer-Led Patient Navigation Intervention for Racially and Ethnically Minoritized Veterans in Veterans Health Administration Mental Health Services: Protocol for a Mixed Methods Randomized Controlled Feasibility Study.

BACKGROUND: Mental health care disparities are persistent and have increased in recent years. Compared with their White counterparts, members of racially and ethnically minoritized groups have less access to mental health care. Minoritized groups also have lower engagement in mental health treatment and are more likely to experience ineffective patient-provider communication, which contribute to negative mental health care experiences and poor mental health outcomes. Interventions that embrace recovery-oriented practices to support patient engagement and empower patients to participate in their mental health care and treatment decisions may help reduce mental health care disparities. Designed to achieve this goal, the Proactive, Recovery-Oriented Treatment Navigation to Engage Racially Diverse Veterans in Mental Healthcare (PARTNER-MH) is a peer-led patient navigation intervention that aims to engage minoritized patients in mental health treatment, support them to play a greater role in their care, and facilitate their participation in shared treatment decision-making. OBJECTIVE: The primary aim of this study is to assess the feasibility and acceptability of PARTNER-MH delivered to patients over 6 months. The second aim is to evaluate the preliminary effects of PARTNER-MH on patient activation, patient engagement, and shared decision-making. The third aim is to examine patient-perceived barriers to and facilitators of engagement in PARTNER-MH as well as contextual factors that may inhibit or promote the integration, sustainability, and scalability of PARTNER-MH using the Consolidated Framework for Implementation Research. METHODS: This pilot study evaluates the feasibility and acceptability of PARTNER-MH in a Veterans Health Administration (VHA) mental health setting using a mixed methods, randomized controlled trial study design. PARTNER-MH is tested under real-world conditions using certified VHA peer specialists (peers) selected through usual VHA hiring practices and assigned to the mental health service line. Peers provide PARTNER-MH and usual peer support services. The study compares the impact of PARTNER-MH versus a wait-list control group on patient activation, patient engagement, and shared decision-making as well as other patient-level outcomes. PARTNER-MH also examines organizational factors that could impact its future implementation in VHA settings. RESULTS: Participants (N=50) were Veterans who were mostly male (n=31, 62%) and self-identified as non-Hispanic (n=44, 88%) and Black (n=35, 70%) with a median age of 45 to 54 years. Most had at least some college education, and 32% (16/50) had completed ≥4 years of college. Randomization produced comparable groups in terms of characteristics and outcome measures at baseline, except for sex. CONCLUSIONS: Rather than simply documenting health disparities among vulnerable populations, PARTNER-MH offers opportunities to evaluate a tailored, culturally sensitive, system-based intervention to improve patient engagement and patient-provider communication in mental health care for racially and ethnically minoritized individuals. TRIAL REGISTRATION: ClinicalTrials.gov NCT04515771; https://clinicaltrials.gov/ct2/show/NCT04515771. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37712.

Diagnostic Value and Cost-Effectiveness of Next-Generation Sequencing-Based Testing for Treatment of Patients with Advanced/Metastatic Non-Squamous Non-Small-Cell Lung Cancer in the United States.

The study evaluated the diagnostic value and cost-effectiveness of next-generation sequencing (NGS)-based testing versus various combinations of single-gene tests (SGTs) for selection of first-line treatment for patients with advanced/metastatic non-squamous non-small-cell lung cancer in the United States. A dynamic decision analysis model was developed comparing NGS versus SGT from a payer perspective. Inputs were obtained from published sources and included diagnostic performance, biomarker-positive disease rates, biomarker-directed recommendations for treatment, and survival outcomes. Costs were reported in 2020 US dollars. In the base case, NGS improved the detection of actionable biomarkers by 74.4%, increased the proportion of patients receiving biomarker-driven therapy by 11.9%, and decreased the proportion of patients with biomarker-positive disease receiving non-biomarker-driven first-line treatment by 40.5%. The incremental cost-effectiveness ratio per life-year gained of NGS testing versus SGT was $7224 (excluding post-diagnostic costs); the incremental cost-effectiveness ratio for NGS-directed therapy was $148,786 versus SGT-directed therapy. Sensitivity analyses confirmed the robustness of these findings; survival outcomes and targeted therapy costs had the greatest impact on results. Testing strategies with NGS are more comprehensive in the detection of actionable biomarkers and can improve the proportion of patients receiving biomarker-driven therapies. NGS testing may provide a cost-effective strategy for advanced/metastatic non-squamous non-small-cell lung cancer; however, the value of NGS-directed therapy varies by the willingness-to-pay threshold of the decision-maker.

Cost-effectiveness of brentuximab vedotin plus chemotherapy for previously untreated CD30-positive peripheral T-cell lymphoma in Canada.

AIMS: To support reimbursement requests in Canada, we evaluated the cost-effectiveness of brentuximab vedotin (Adcetris) in combination with cyclophosphamide, doxorubicin, and prednisone (A + CHP) compared with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) as frontline treatment for CD30-expressing peripheral T-cell lymphomas (PTCLs) using results from the ECHELON-2 clinical trial. The PTCL subtypes included were systemic anaplastic large cell lymphoma (sALCL), PTCL-not otherwise specified (PTCL-NOS), and angioimmunoblastic T-cell lymphoma (AITL). MATERIALS AND METHODS: A partitioned survival model consisting of three health states (progression-free survival [PFS], post-progression survival [PPS], and death) was constructed from the perspective of the Canadian publicly funded healthcare system over a lifetime horizon. Efficacy, safety, and health-related quality-of-life (HRQoL) data were obtained from ECHELON-2. Medical resource use and costs were derived from Canadian literature and standard sources. Incremental cost-effectiveness ratios (ICERs) per life-years (LYs) and quality-adjusted life-years (QALYs) gained were calculated. Sensitivity analyses were performed to account for uncertainty in key parameters. All costs are reported in Canadian dollars. RESULTS: A + CHP, when compared with CHOP, was associated with an estimated mean gain of 2.90 LYs and 2.38 QALYs and a mean incremental cost of $76,491. The ICER for A + CHP compared with CHOP was estimated at $26,340 per LY gained and $32,177 per QALY gained. In sensitivity analyses, the ICERs remained below $60,000 per QALY gained. Time horizon, patient starting age, and discount rate affected the results, as the ICER was driven by long-term survival gains observed with A + CHP compared with CHOP. LIMITATIONS: Real-world downstream treatments (such as stem cell transplantation) may differ from the treatment protocol followed in the ECHELON-2 trial. CONCLUSIONS: A + CHP compared with CHOP provides a cost-effective treatment option with improved clinical outcomes that are clinically relevant and a comparable safety profile for adults with previously untreated CD30-expressing sALCL, PTCL-NOS, or AITL in Canada.

Reciprocal Social Behavior and Related Social Outcomes in Individuals at Clinical High Risk for Psychosis.

Reciprocal social behavior (RSB) deficits have been noted in formal psychotic disorders and may play a role in the clinical high-risk for psychosis (CHR) syndrome. The present study examined RSB deficits and clinical and social functioning correlates in 45 individuals meeting criteria for a CHR syndrome and 47 healthy comparisons (HC). Further, this study examined associations with number of friends, problematic social Internet use, and perceived social support. Compared to the HC group, the CHR group exhibited greater deficits in total RSB and in all RSB subdomains. Total RSB deficits were associated with greater negative but not positive symptom severity in the CHR group, and greater social functional impairment. RSB deficits also may have related to fewer friendships, more problematic social Internet use, and less perceived belonging and tangible social support, although relationships with Internet use and perceived social support did not survive FDR-correction. These findings provide further evidence that RSB is impaired in the CHR syndrome and suggest specific social outcomes that may be affected. Further investigations with larger, diverse samples and repeated measures can confirm these findings.

Economic Evaluation of an N-terminal Pro B-type Natriuretic Peptide-Supported Diagnostic Strategy Among Dyspneic Patients Suspected of Acute Heart Failure in the Emergency Department.

Our objective was to perform an economic evaluation of an N-terminal pro B-type natriuretic peptide (NT-proBNP)-supported diagnostic strategy in dyspneic patients suspected of acute heart failure in the emergency department (ED). A decision-tree model was developed to evaluate clinical outcomes and costs for NT-proBNP-supported assessment compared with clinical assessment alone over 6 months from the United States (US) Medicare perspective. The model considered rule-in/rule-out cutoffs identified in the ICON and ICON-RELOADED studies. Acute heart failure prevalence, diagnostic accuracies, and medical resource use conditional on disease status and test results were derived from ICON-RELOADED. Several assumptions based on previous studies of NT-proBNP acute dyspnea and verified with clinicians were applied to medical resource use and assessed in sensitivity analyses. Compared with clinical assessment alone, NT-proBNP-supported assessment improved overall probability of correct diagnosis by a relative 7% (18% for true-positive and 5% for true-negative). This led to relative reductions in medical resource use in ED and hospital, including fewer initial hospitalizations (-14%), required echocardiograms (-31%), cardiology admissions (-16%), intensive care unit admissions (-12%), ED readmissions (-3%), and hospital readmissions (-22%). NT-proBNP use decreased average inpatient management costs by a relative 10%, yielding cost savings of US$2,337 per patient ED visit. These findings were robust in sensitivity analyses. In conclusion, based on a contemporary trial of patients with acute dyspnea, this analysis reaffirmed that using NT-proBNP as a diagnostic tool may improve the management of patients with dyspnea presenting to EDs and is likely to be cost-saving from the US Medicare perspective.

Cost-effectiveness of brentuximab vedotin with chemotherapy in treatment of CD30-expressing PTCL.

OBJECTIVES: To evaluate the cost-effectiveness of brentuximab vedotin (Adcetris) in combination with cyclophosphamide, doxorubicin, and prednisone (A+CHP) in the first-line setting for CD30-expressing peripheral T-cell lymphoma (PTCL). STUDY DESIGN: An economic model was developed using clinical and quality-of-life (QOL) data from the ECHELON-2 trial, in which A+CHP demonstrated significant improvement in progression-free survival (PFS) and overall survival (OS) versus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). METHODS: A partitioned survival model, consisting of 3 health states (PFS, postprogression survival, and death), was constructed from a US payer perspective over a lifetime time horizon. PFS and OS observed from ECHELON-2 were extrapolated using standard parametric distributions. The best-fitting distributions (log-normal for both arms) were selected based on statistical goodness of fit and clinical plausibility of the long-term projections. Utilities were based on the European Quality of Life 5-Dimensional data collected in ECHELON-2. Medical resource use and costs were from literature and standard sources. RESULTS: The model predicted that A+CHP extended PFS and OS by 2.92 and 3.38 years, respectively, over CHOP. After incorporating QOL and discounting, A+CHP was associated with 1.79 quality-adjusted life-years gained at a total incremental cost of $159,388, resulting in an incremental cost-effectiveness ratio (ICER) of $89,217. Sensitivity analyses provided ICERs ranging approximately from $57,000 to $138,000. The estimated probability that A+CHP is cost-effective compared with CHOP was 82% at a willingness-to-pay threshold of $150,000. CONCLUSIONS: Based on the ECHELON-2 trial data, this analysis found A+CHP to be cost-effective for patients with previously untreated CD30-expressing PTCL.

Neighborhood crime, socioeconomic status, and suspiciousness in adolescents and young adults at Clinical High Risk (CHR) for psychosis.

INTRODUCTION: Contextual factors representing chronic stressors, such as neighborhood crime characteristics, have been repeatedly linked to compromised mental and physical health, and may contribute to the pathologizing of normative/non-clinical experiences. However, the impact of such structural factors has seldom been incorporated in Clinical High Risk (CHR) for psychosis research. Understanding how context can influence the presence or severity of symptoms such as suspiciousness/paranoia may have important relevance for promoting valid and reliable assessment, as well as for understanding ways in which environment may be related to illness development and expression. METHODS: A total of 126 adolescents and young adults (nCHR = 63, ncontrol = 63) underwent clinical interviews for Clinical High-Risk syndromes. Neighborhood crime indices and socioeconomic status were calculated through geocoding and extracting of publicly available Census and Federal Bureau of Investigation (FBI) data. Analyses examined presence of associations between neighborhood crime indices, socioeconomic status, suspiciousness and total symptoms. RESULTS: Greater neighborhood crime was related to increased suspiciousness in CHR individuals, even after controlling for neighborhood socioeconomic status, r = 0.27, p = .03. Neighborhood crime was not related to total symptoms, and neither was neighborhood socioeconomic status. DISCUSSION: Results suggest neighborhood crime uniquely related to suspiciousness symptoms in CHR individuals, while this was not the case for healthy volunteers (HV). Future work will be critical for determining the extent to which assessors are pathologizing experiences that are normative for a particular context, or rather, if a stressful context is serving as a sufficient environmental stressor to unmask emerging psychosis.

Assessing Developmental Environmental Risk Factor Exposure in Clinical High Risk for Psychosis Individuals: Preliminary Results Using the Individual and Structural Exposure to Stress in Psychosis-Risk States Scale.

INTRODUCTION: Exposure to cumulative environmental risk factors across development has been linked to a host of adverse health/functional outcomes. This perspective incorporating information regarding exposure at differing developmental periods is lacking in research surrounding individuals at Clinical High Risk (CHR) for developing a psychotic disorder. METHODS: CHR individuals (n = 35) and healthy volunteers (n = 28) completed structured clinical interviews as well as our group's newly developed Individual and Structural Exposure to Stress in Psychosis-risk-states (ISESP) interview. Lifetime cumulative scores were calculated, and severity of stress was reported for multiple developmental periods/ages. Group differences were tested, and associations with current symptom domains were examined. RESULTS: Significant group differences were not observed for lifetime cumulative events, though CHR trended toward endorsing more events and greater stress severity. For stress severity across development, there were trending group differences for the 11-13 age range, and significant group differences for the 14-18 age range; notably, comparisons for earlier time points did not approach statistical significance. Associations between negative symptoms and cumulative severity of exposure were observed. DISCUSSION: Results suggest exploring exposure to cumulative environmental risk factors/stressors and stress severity across developmental periods is generally informative and possibly specifically so for predictive models and diathesis-stress psychosis risk conceptualizations.

Examining the Relationship Between Parent and Child Psychopathology in Treatment-Seeking Veterans.

This study aimed to examine: (1) the relationship between parental psychopathology and child psychopathology in military families and (2) parenting sense of competence as a mediator of the relationship between veteran psychopathology and child psychopathology. As part of their standard clinical evaluations, 215 treatment-seeking veterans who reported having a child between the ages of 4 and 17 were assessed for psychopathology (posttraumatic stress disorder, depression, anxiety, and stress), their sense of competence as a parent, and their child's psychopathology (internalizing, externalizing, and attentional symptoms). A path analysis model examining parenting sense of competence as a mediator of the relationship between veteran psychopathology and child psychopathology showed significant indirect effects of veteran depression on all child psychopathology outcomes via parenting sense of competence. Parental sense of competence may be a critical mechanism linking veteran depression and child psychopathology, and may therefore be an important target for intervention.

Negative Posttrauma Cognitions Mediate the Association Between Morally Injurious Events and Trauma-Related Psychopathology in Treatment-Seeking Veterans.

Exposure to potentially morally injurious events has been shown to be associated with posttraumatic stress disorder (PTSD) and depression symptoms in military personnel. Few studies have examined factors that help to explain how potentially morally injurious events may contribute to the development of trauma-related psychopathology. Negative posttrauma cognitions are thought to play a role in the etiology of PTSD and depression following trauma; however, it is unclear whether more global beliefs about the self, others, and world play a role in the development of PTSD and depression due to morally injurious events. Using structural equation modeling, we tested whether morally injurious experiences were indirectly related to trauma-related psychopathology (PTSD and depression) through negative posttrauma cognitions in a sample of veterans seeking treatment for PTSD. An indirect effects only model best fit the data and showed that morally injurious experiences, specifically perceived transgressions by oneself and perceived betrayal, were indirectly associated with trauma-related psychopathology through negative posttrauma cognitions, ß = .17; 95% CI [.04, .31] and ß = .25; 95% CI [.11, .41], respectively. Our findings suggest that negative posttrauma cognitions may be an important mechanism linking exposure to morally injurious events and trauma-related psychopathology.

A Cost-effectiveness Analysis of Brentuximab Vedotin in Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma.

Objective: To evaluate the cost-effectiveness of brentuximab vedotin in patients with R/R sALCL from a UK NHS perspective. Methods: A partitioned survival model used clinical outcomes for brentuximab vedotin from the pivotal phase-2 single-arm trial of brentuximab vedotin in 58 patients with R/R sALCL (SG035-0004; NCT00866047), over a lifetime (30-year) time horizon. Comparison with conventional chemotherapy was based on data from the Canadian British Columbia Cancer Agency registry from 40 patients starting salvage chemotherapy after front-line treatment between 1980 and 2012. Survival was extrapolated using parametric distributions, with brentuximab vedotin risk after the trial period assumed equal to conventional chemotherapy. Other modelling assumptions were based on a systematic literature review and clinical expert opinion. Results: Based on statistical extrapolation, brentuximab vedotin was associated with 3.1 years longer duration in the progression-free survival health state and an overall survival improvement of 5.4 years, prior to discounting. In addition, brentuximab vedotin was associated with 2.5 quality-adjusted life years (QALYs) gained at a total incremental cost of £88 556, resulting in an incremental cost-effectiveness ratio (ICER) of approximately £35 400. Sensitivity analyses of alternative model assumptions provided ICERs ranging from approximately £28 100 to £61 900. Comparing only first-line salvage patients reduced the ICER to £26 800 per QALY gained. Conversely, considering only patients with Eastern Corporative Oncology Group performance status of 0 or 1 increased the ICER to approximately £38 200. At a willingness-to-pay threshold of £50 000, the estimated probability that brentuximab vedotin is cost-effective compared with conventional chemotherapy was 86.5%. Conclusion: Compared to conventional chemotherapy, and considering the full survival period, brentuximab vedotin may provide a valuable treatment choice for patients with R/R sALCL, a population with limited therapeutic options.

The cost-effectiveness of screening for colorectal cancer.

BACKGROUND: Published decision analyses show that screening for colorectal cancer is cost-effective. However, because of the number of tests available, the optimal screening strategy in Canada is unknown. We estimated the incremental cost-effectiveness of 10 strategies for colorectal cancer screening, as well as no screening, incorporating quality of life, noncompliance and data on the costs and benefits of chemotherapy. METHODS: We used a probabilistic Markov model to estimate the costs and quality-adjusted life expectancy of 50-year-old average-risk Canadians without screening and with screening by each test. We populated the model with data from the published literature. We calculated costs from the perspective of a third-party payer, with inflation to 2007 Canadian dollars. RESULTS: Of the 10 strategies considered, we focused on three tests currently being used for population screening in some Canadian provinces: low-sensitivity guaiac fecal occult blood test, performed annually; fecal immunochemical test, performed annually; and colonoscopy, performed every 10 years. These strategies reduced the incidence of colorectal cancer by 44%, 65% and 81%, and mortality by 55%, 74% and 83%, respectively, compared with no screening. These strategies generated incremental cost-effectiveness ratios of $9159, $611 and $6133 per quality-adjusted life year, respectively. The findings were robust to probabilistic sensitivity analysis. Colonoscopy every 10 years yielded the greatest net health benefit. INTERPRETATION: Screening for colorectal cancer is cost-effective over conventional levels of willingness to pay. Annual high-sensitivity fecal occult blood testing, such as a fecal immunochemical test, or colonoscopy every 10 years offer the best value for the money in Canada.

Costs associated with diffuse large B-cell lymphoma patient treatment in a Canadian integrated cancer care center.

OBJECTIVE: The objective of this study was to provide a detailed comparative microcosting analysis for two cancer treatment pathways to contribute evidence for resource allocation and operational decision-making in a Canadian cancer care context. METHODS: We estimated direct medical costs (in 2004 CAN$) of the entire pathway of care for diffuse large B-cell lymphoma (DLBCL) patients in a large Canadian cancer treatment center. Patient samples were defined as those who received R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone; n = 85) or CHOP (i.e., without rituximab; n = 86) as first-line treatment. All subsequent treatments including palliative care for these patient samples were assessed. Hospitalization costs and unit costs of medical resources were collected from integrated medical organizations. Individual patient resource consumption was assessed via medical chart review. RESULTS: For first-line treatment, drug cost was the largest contributor to total cost, followed by hospitalization cost. Rituximab was the largest contributor to mean cost differences between R-CHOP and CHOP treatments. For treatments subsequent to first-line treatment, no significant cost differences were found. Hospitalization and transplantation costs were the two largest constituents of total costs subsequent to first-line treatment, followed by drug cost. Patients with advanced stage disease cost significantly more than patients with limited stage disease. CONCLUSION: This is the first detailed microcosting study that has employed consistent local data to estimate total medical costs for DLBCL patients in Canada. This information is useful for resource allocation planning and operational decisions, because it provides more substantive, relevant evidence as compared to aggregated, literature or extrapolated information.