Clinical and cost-effectiveness of 'Live Well with Parkinson's' self-management intervention versus treatment as usual for improving quality of life for people with Parkinson's: study protocol for a randomised controlled trial.

BACKGROUND: The Live Well with Parkinson's Self-Management Toolkit is designed for use in the NHS to support people with Parkinson's, their carers and health professionals in managing motor and non-motor symptoms and promoting well-being. The Toolkit was developed based on theory-based behaviour change and self-management techniques in consultation with people living with Parkinson's and health and social care practitioners. There are digital (e-Toolkit) and paper (manual) versions. METHODS: Single-blind two-arm randomised controlled trial RCT of clinical effectiveness and cost-effectiveness of the Toolkit, facilitated by up to six sessions with a trained non-specialist supporter, in improving quality of life. People with Parkinson's will be assessed at baseline, 6 and 12 months. Assessors will be blind to the treatment group. The primary outcome measure is the Parkinson's Disease Questionnaire (PDQ-39, Parkinson's related quality of life) score at 12 months. Secondary outcome measures include the MDS Unified Parkinson's Disease Rating Scale (Part I, II, III, IV), EQ-5D, and a Client Service Receipt Inventory shortened, adapted for Parkinson's. Carer outcomes include the Zarit Carer Burden Inventory and Carer Quality of Life Questionnaire for Parkinsonism. A total of 338 people with Parkinson's, and their carers if appropriate, will be recruited from diverse settings across England. Those with advanced dementia, at end-of-life or with atypical Parkinsonism will be excluded. A parallel mixed methods process evaluation will explore the factors promoting or inhibiting implementation, uptake, use, effectiveness and cost-effectiveness of the Toolkit and sessions. DISCUSSION: If successful, the Live Well with Parkinson's Toolkit could be used as a model for other complex long-term disorders, including dementia. This would bridge existing gaps in the NHS (as shown by the national Parkinson's audit data), by enabling patients and carers to access personalised information, advice and support on symptom management and 'living well' with Parkinson's. TRIAL REGISTRATION: ISRCTN92831552. Registered on 26th Oct 2021.

Lamotrigine versus levetiracetam or zonisamide for focal epilepsy and valproate versus levetiracetam for generalised and unclassified epilepsy: two SANAD II non-inferiority RCTs.

BACKGROUND: Levetiracetam (Keppra®, UCB Pharma Ltd, Slough, UK) and zonisamide (Zonegran®, Eisai Co. Ltd, Tokyo, Japan) are licensed as monotherapy for focal epilepsy, and levetiracetam is increasingly used as a first-line treatment for generalised epilepsy, particularly for women of childbearing age. However, there is uncertainty as to whether or not they should be recommended as first-line treatments owing to a lack of evidence of clinical effectiveness and cost-effectiveness. OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of lamotrigine (Lamictal®, GlaxoSmithKline plc, Brentford, UK) (standard treatment) with levetiracetam and zonisamide (new treatments) for focal epilepsy, and to compare valproate (Epilim®, Sanofi SA, Paris, France) (standard treatment) with levetiracetam (new treatment) for generalised and unclassified epilepsy. DESIGN: Two pragmatic randomised unblinded non-inferiority trials run in parallel. SETTING: Outpatient services in NHS hospitals throughout the UK. PARTICIPANTS: Those aged ≥ 5 years with two or more spontaneous seizures that require anti-seizure medication. INTERVENTIONS: Participants with focal epilepsy were randomised to receive lamotrigine, levetiracetam or zonisamide. Participants with generalised or unclassifiable epilepsy were randomised to receive valproate or levetiracetam. The randomisation method was minimisation using a web-based program. MAIN OUTCOME MEASURES: The primary outcome was time to 12-month remission from seizures. For this outcome, and all other time-to-event outcomes, we report hazard ratios for the standard treatment compared with the new treatment. For the focal epilepsy trial, the non-inferiority limit (lamotrigine vs. new treatments) was 1.329. For the generalised and unclassified epilepsy trial, the non-inferiority limit (valproate vs. new treatments) was 1.314. Secondary outcomes included time to treatment failure, time to first seizure, time to 24-month remission, adverse reactions, quality of life and cost-effectiveness. RESULTS: Focal epilepsy. A total of 990 participants were recruited, of whom 330 were randomised to receive lamotrigine, 332 were randomised to receive levetiracetam and 328 were randomised to receive zonisamide. Levetiracetam did not meet the criteria for non-inferiority (hazard ratio 1.329) in the primary intention-to-treat analysis of time to 12-month remission (hazard ratio vs. lamotrigine 1.18, 97.5% confidence interval 0.95 to 1.47), but zonisamide did meet the criteria (hazard ratio vs. lamotrigine 1.03, 97.5% confidence interval 0.83 to 1.28). In the per-protocol analysis, lamotrigine was superior to both levetiracetam (hazard ratio 1.32, 95% confidence interval 1.05 to 1.66) and zonisamide (hazard ratio 1.37, 95% confidence interval 1.08 to 1.73). For time to treatment failure, lamotrigine was superior to levetiracetam (hazard ratio 0.60, 95% confidence interval 0.46 to 0.77) and zonisamide (hazard ratio 0.46, 95% confidence interval 0.36 to 0.60). Adverse reactions were reported by 33% of participants starting lamotrigine, 44% starting levetiracetam and 45% starting zonisamide. In the economic analysis, both levetiracetam and zonisamide were more costly and less effective than lamotrigine and were therefore dominated. Generalised and unclassifiable epilepsy. Of 520 patients recruited, 260 were randomised to receive valproate and 260 were randomised to receive to levetiracetam. A total of 397 patients had generalised epilepsy and 123 had unclassified epilepsy. Levetiracetam did not meet the criteria for non-inferiority in the primary intention-to-treat analysis of time to 12-month remission (hazard ratio 1.19, 95% confidence interval 0.96 to 1.47; non-inferiority margin 1.314). In the per-protocol analysis of time to 12-month remission, valproate was superior to levetiracetam (hazard ratio 1.68, 95% confidence interval 1.30 to 2.15). Valproate was superior to levetiracetam for time to treatment failure (hazard ratio 0.65, 95% confidence interval 0.50 to 0.83). Adverse reactions were reported by 37.4% of participants receiving valproate and 41.5% of those receiving levetiracetam. Levetiracetam was both more costly (incremental cost of £104, 95% central range -£587 to £1234) and less effective (incremental quality-adjusted life-year of -0.035, 95% central range -0.137 to 0.032) than valproate, and was therefore dominated. At a cost-effectiveness threshold of £20,000 per quality-adjusted life-year, levetiracetam was associated with a probability of 0.17 of being cost-effective. LIMITATIONS: The SANAD II trial was unblinded, which could have biased results by influencing decisions about dosing, treatment failure and the attribution of adverse reactions. FUTURE WORK: SANAD II data could now be included in an individual participant meta-analysis of similar trials, and future similar trials are required to assess the clinical effectiveness and cost-effectiveness of other new treatments, including lacosamide and perampanel. CONCLUSIONS: Focal epilepsy - The SANAD II findings do not support the use of levetiracetam or zonisamide as first-line treatments in focal epilepsy. Generalised and unclassifiable epilepsy - The SANAD II findings do not support the use of levetiracetam as a first-line treatment for newly diagnosed generalised epilepsy. For women of childbearing potential, these results inform discussions about the benefit (lower teratogenicity) and harm (worse seizure outcomes and higher treatment failure rate) of levetiracetam compared with valproate. TRIAL REGISTRATION: Current Controlled Trials ISRCTN30294119 and EudraCT 2012-001884-64. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 75. See the NIHR Journals Library website for further project information.

BACKGROUND AND METHODS: The SANAD II trial was a clinical trial designed to identify the most clinically effective and cost-effective treatment for adults and children aged > 5 years with newly diagnosed epilepsy. There are two main epilepsy types: focal and generalised. In focal epilepsy, seizures start at a single place in the brain (a focus), whereas in generalised epilepsy seizures start in both sides of the brain at the same time. Anti-seizure medications are the main treatment. For people with newly diagnosed epilepsy, the first anti-seizure medication should control the seizures as quickly as possible while avoiding side effects. The first-choice treatments are lamotrigine (Lamictal®, GlaxoSmithKline plc, Brentford, UK) for focal epilepsy and valproate (Epilim®, Sanofi SA, Paris, France) for generalised epilepsy (however, the latter should be avoided in women who could become pregnant). A number of newer anti-seizure medications have been approved for NHS use, but it is unclear whether or not they should be used as first-line treatments. The SANAD II trial focused on the new medicines levetiracetam (Keppra®, UCB Pharma Ltd, Slough, UK) and zonisamide (Zonegran®, Eisai Co. Ltd, Tokyo, Japan). We recruited 1510 people aged ≥ 5 years with newly diagnosed epilepsy: 990 with focal epilepsy and 520 with generalised or unclassified epilepsy. FINDINGS: FOCAL EPILEPSY: People starting treatment with levetiracetam or zonisamide were significantly less likely to have a 12-month remission from seizures than people starting treatment with lamotrigine, unless they were changed to another anti-seizure medication. Side effects that were thought to be caused by anti-seizure medications were reported by 33% of participants starting lamotrigine, 44% of those starting levetiracetam and 45% of those starting zonisamide. The cost-effectiveness analyses showed that neither levetiracetam nor zonisamide is value for money for the NHS when compared with lamotrigine. The SANAD II findings do not support the use of levetiracetam or zonisamide as first-line treatments in focal epilepsy. FINDINGS: GENERALISED AND UNCLASSIFIABLE EPILEPSY: People starting treatment with levetiracetam were significantly less likely to have a 12-month remission from seizures than people starting valproate, unless they were changed to another anti-seizure medication. Side effects that were thought to be caused by anti-seizure medications were reported by 37% of participants starting valproate and 42% of participants starting levetiracetam. The cost-effectiveness analyses showed that levetiracetam is not good value for money for the NHS when compared with valproate. The SANAD II findings do not support the use of levetiracetam as a first-line treatment for newly diagnosed generalised epilepsy. Importantly, our results will inform treatment decisions for women, who may choose a less effective treatment that is safer in pregnancy.

The SANAD II study of the effectiveness and cost-effectiveness of levetiracetam, zonisamide, or lamotrigine for newly diagnosed focal epilepsy: an open-label, non-inferiority, multicentre, phase 4, randomised controlled trial.

BACKGROUND: Levetiracetam and zonisamide are licensed as monotherapy for patients with focal epilepsy, but there is uncertainty as to whether they should be recommended as first-line treatments because of insufficient evidence of clinical effectiveness and cost-effectiveness. We aimed to assess the long-term clinical effectiveness and cost-effectiveness of levetiracetam and zonisamide compared with lamotrigine in people with newly diagnosed focal epilepsy. METHODS: This randomised, open-label, controlled trial compared levetiracetam and zonisamide with lamotrigine as first-line treatment for patients with newly diagnosed focal epilepsy. Adult and paediatric neurology services across the UK recruited participants aged 5 years or older (with no upper age limit) with two or more unprovoked focal seizures. Participants were randomly allocated (1:1:1) using a minimisation programme with a random element utilising factor to receive lamotrigine, levetiracetam, or zonisamide. Participants and investigators were not masked and were aware of treatment allocation. SANAD II was designed to assess non-inferiority of both levetiracetam and zonisamide to lamotrigine for the primary outcome of time to 12-month remission. Anti-seizure medications were taken orally and for participants aged 12 years or older the initial advised maintenance doses were lamotrigine 50 mg (morning) and 100 mg (evening), levetiracetam 500 mg twice per day, and zonisamide 100 mg twice per day. For children aged between 5 and 12 years the initial daily maintenance doses advised were lamotrigine 1·5 mg/kg twice per day, levetiracetam 20 mg/kg twice per day, and zonisamide 2·5 mg/kg twice per day. All participants were included in the intention-to-treat (ITT) analysis. The per-protocol (PP) analysis excluded participants with major protocol deviations and those who were subsequently diagnosed as not having epilepsy. Safety analysis included all participants who received one dose of any study drug. The non-inferiority limit was a hazard ratio (HR) of 1·329, which equates to an absolute difference of 10%. A HR greater than 1 indicated that an event was more likely on lamotrigine. The trial is registered with the ISRCTN registry, 30294119 (EudraCt number: 2012-001884-64). FINDINGS: 990 participants were recruited between May 2, 2013, and June 20, 2017, and followed up for a further 2 years. Patients were randomly assigned to receive lamotrigine (n=330), levetiracetam (n=332), or zonisamide (n=328). The ITT analysis included all participants and the PP analysis included 324 participants randomly assigned to lamotrigine, 320 participants randomly assigned to levetiracetam, and 315 participants randomly assigned to zonisamide. Levetiracetam did not meet the criteria for non-inferiority in the ITT analysis of time to 12-month remission versus lamotrigine (HR 1·18; 97·5% CI 0·95-1·47) but zonisamide did meet the criteria for non-inferiority in the ITT analysis versus lamotrigine (1·03; 0·83-1·28). The PP analysis showed that 12-month remission was superior with lamotrigine than both levetiracetam (HR 1·32 [97·5% CI 1·05 to 1·66]) and zonisamide (HR 1·37 [1·08-1·73]). There were 37 deaths during the trial. Adverse reactions were reported by 108 (33%) participants who started lamotrigine, 144 (44%) participants who started levetiracetam, and 146 (45%) participants who started zonisamide. Lamotrigine was superior in the cost-utility analysis, with a higher net health benefit of 1·403 QALYs (97·5% central range 1·319-1·458) compared with 1·222 (1·110-1·283) for levetiracetam and 1·232 (1·112, 1·307) for zonisamide at a cost-effectiveness threshold of £20 000 per QALY. Cost-effectiveness was based on differences between treatment groups in costs and QALYs. INTERPRETATION: These findings do not support the use of levetiracetam or zonisamide as first-line treatments for patients with focal epilepsy. Lamotrigine should remain a first-line treatment for patients with focal epilepsy and should be the standard treatment in future trials. FUNDING: National Institute for Health Research Health Technology Assessment programme.

The SANAD II study of the effectiveness and cost-effectiveness of valproate versus levetiracetam for newly diagnosed generalised and unclassifiable epilepsy: an open-label, non-inferiority, multicentre, phase 4, randomised controlled trial.

BACKGROUND: Valproate is a first-line treatment for patients with newly diagnosed idiopathic generalised or difficult to classify epilepsy, but not for women of child-bearing potential because of teratogenicity. Levetiracetam is increasingly prescribed for these patient populations despite scarcity of evidence of clinical effectiveness or cost-effectiveness. We aimed to compare the long-term clinical effectiveness and cost-effectiveness of levetiracetam compared with valproate in participants with newly diagnosed generalised or unclassifiable epilepsy. METHODS: We did an open-label, randomised controlled trial to compare levetiracetam with valproate as first-line treatment for patients with generalised or unclassified epilepsy. Adult and paediatric neurology services (69 centres overall) across the UK recruited participants aged 5 years or older (with no upper age limit) with two or more unprovoked generalised or unclassifiable seizures. Participants were randomly allocated (1:1) to receive either levetiracetam or valproate, using a minimisation programme with a random element utilising factors. Participants and investigators were aware of treatment allocation. For participants aged 12 years or older, the initial advised maintenance doses were 500 mg twice per day for levetiracetam and valproate, and for children aged 5-12 years, the initial daily maintenance doses advised were 25 mg/kg for valproate and 40 mg/kg for levetiracetam. All drugs were administered orally. SANAD II was designed to assess the non-inferiority of levetiracetam compared with valproate for the primary outcome time to 12-month remission. The non-inferiority limit was a hazard ratio (HR) of 1·314, which equates to an absolute difference of 10%. A HR greater than 1 indicated that an event was more likely on valproate. All participants were included in the intention-to-treat (ITT) analysis. Per-protocol (PP) analyses excluded participants with major protocol deviations and those who were subsequently diagnosed as not having epilepsy. Safety analyses included all participants who received one dose of any study drug. This trial is registered with the ISRCTN registry, 30294119 (EudraCt number: 2012-001884-64). FINDINGS: 520 participants were recruited between April 30, 2013, and Aug 2, 2016, and followed up for a further 2 years. 260 participants were randomly allocated to receive levetiracetam and 260 participants to receive valproate. The ITT analysis included all participants and the PP analysis included 255 participants randomly allocated to valproate and 254 randomly allocated to levetiracetam. Median age of participants was 13·9 years (range 5·0-94·4), 65% were male and 35% were female, 397 participants had generalised epilepsy, and 123 unclassified epilepsy. Levetiracetam did not meet the criteria for non-inferiority in the ITT analysis of time to 12-month remission (HR 1·19 [95% CI 0·96-1·47]); non-inferiority margin 1·314. The PP analysis showed that the 12-month remission was superior with valproate than with levetiracetam. There were two deaths, one in each group, that were unrelated to trial treatments. Adverse reactions were reported by 96 (37%) participants randomly assigned to valproate and 107 (42%) participants randomly assigned to levetiracetam. Levetiracetam was dominated by valproate in the cost-utility analysis, with a negative incremental net health benefit of -0·040 (95% central range -0·175 to 0·037) and a probability of 0·17 of being cost-effectiveness at a threshold of £20 000 per quality-adjusted life-year. Cost-effectiveness was based on differences between treatment groups in costs and quality-adjusted life-years. INTERPRETATION: Compared with valproate, levetiracetam was found to be neither clinically effective nor cost-effective. For girls and women of child-bearing potential, these results inform discussions about benefit and harm of avoiding valproate. FUNDING: National Institute for Health Research Health Technology Assessment Programme.

A comparative assessment of the performance of a state-of-the art small footprint dedicated cardiovascular CT scanner.

INTRODUCTION: With increasing adoption of CT coronary angiography (CTA) there is increasing demand for cost-effective, small footprint, dedicated cardiac scanners. We compared a state-of-the-art, small footprint dedicated cardiac scanner (DCCT) to a standard multidetector scanner (MDCT). METHODS: The study was a retrospective unblinded single centre study. A total of 800 patients were included, with 400 undergoing a DCCT and MDCT coronary CTA scanning, respectively. Image quality was assessed using a 4-point grading score. Image noise and artifact, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR), and acceptance rate for CT-derived fractional flow reserve (FFRct) were recorded. RESULTS: Overall image quality was higher in the DCCT group (3.8 ± 0.55 vs 3.6 ± 0.69; p = 0.042). There was no difference in overall image noise (p = 0.131) or artifact (p = 0.295). SNR was superior in the DCCT group (14.2 ± 6.85 vs 11.4 ± 3.32; p < 0.005) as was CNR (12.7 ± 6.77 vs 11.9 ± 3.29; p < 0.005). The heart rate was lower in the DCCT group (56 ± 9.1 vs 59 ± 8.1; p < 0.005). No difference in the dose length product (DLP median 244.53 (IQR 105.6) vs 237.63 (IQR 160.1); p = 0.313) or FFRCT acceptance rate (100 vs 97.7%; p > 0.05) was noted. Independent predictors of excellent quality regardless of scanner type were age (p = 0.011), heart rate <65 bpm (p < 0.005), and body mass index < 35 (p < 0.005). CONCLUSION: A DCCT scanner is capable of image quality similar to modern current generation general purpose CT technology. Such technology appears to be a viable option to serve the increasing demand for CTCA imaging.

Strategic design of wall envelopes for the enhancement of building thermal performance at reduced air-conditioning costs.

A strategy is proposed for the design of wall envelopes to improve unsteady thermal performance in non-air-conditioned buildings and to reduce energy costs in air-conditioned buildings. The thermophysical properties of building materials (e.g., burnt bricks, mud bricks, laterite stone, cinder concrete, and expanded polystyrene) were measured experimentally using a thermal analyzer. A total of 28 combinations for composite walls were designed with expanded polystyrene as an insulation material based on seven criteria and were subjected to 8 different external surface heat transfer coefficients, which were tested for unsteady thermal performance parameters and air-conditioning cost-saving potential. In this paper, unsteady thermal transmittance obtained from admittance method has been employed to compute cost saving potential of air-conditioning for the various wall envelopes. The use of C-H5 design at a 2 m/s wind speed was found to increase the decrement lag of burnt brick, mud brick, laterite stone, and cinder concrete composite wall envelopes by 48.1%, 49.0%, 59.5%, and 47.0%, respectively, relative to the common wall design (C-H1) in non-air-conditioned buildings. The laterite with a C-H5 design offers the highest annual energy cost savings (1.71 $/m2 at 2 m/s), the highest life cycle cost savings (18.32 $/m2 at 2 m/s), and the lowest payback period (4.03 yrs at 2 m/s) in all tested building materials for air-conditioned buildings. The overall results of this study are expected to open new paths to deliver simple design strategies for energy-efficient buildings.

Monte Carlo dosimetry of a realistic multicellular model of follicular lymphoma in a context of radioimmunotherapy.

PURPOSE: Small-scale dosimetry studies generally consider an artificial environment where the tumors are spherical and the radionuclides are homogeneously biodistributed. However, tumor shapes are irregular and radiopharmaceutical biodistributions are heterogeneous, impacting the energy deposition in targeted radionuclide therapy. To bring realism, we developed a dosimetric methodology based on a three-dimensional in vitro model of follicular lymphoma incubated with rituximab, an anti-CD20 monoclonal antibody used in the treatment of non-Hodgkin lymphomas, which might be combined with a radionuclide. The effects of the realistic geometry and biodistribution on the absorbed dose were highlighted by comparison with literature data. Additionally, to illustrate the possibilities of this methodology, the effect of different radionuclides on the absorbed dose distribution delivered to the in vitro tumor were compared. METHODS: The starting point was a model named multicellular aggregates of lymphoma cells (MALC). Three MALCs of different dimensions and their rituximab biodistribution were considered. Geometry, antibody location and concentration were extracted from selective plane illumination microscopy. Assuming antibody radiolabeling with Auger electron (125 I and 111 In) and ß- particle emitters (177 Lu, 131 I and 90 Y), we simulated energy deposition in MALCs using two Monte Carlo codes: Geant4-DNA with "CPA100" physics models for Auger electron emitters and Geant4 with "Livermore" physics models for ß- particle emitters. RESULTS: MALCs had ellipsoid-like shapes with major radii, r, of ~0.25, ~0.5 and ~1.3 mm. Rituximab was concentrated in the periphery of the MALCs. The absorbed doses delivered by 177 Lu, 131 I and 90 Y in MALCs were compared with literature data for spheres with two types of homogeneous biodistributions (on the surface or throughout the volume). Compared to the MALCs, the mean absorbed doses delivered in spheres with surface biodistributions were between 18% and 38% lower, while with volume biodistribution they were between 15% and 29% higher. Regarding the radionuclides comparison, the relationship between MALC dimensions, rituximab biodistribution and energy released per decay impacted the absorbed doses. Despite releasing less energy, 125 I delivered a greater absorbed dose per decay than 111 In in the r ~ 0.25 mm MALC (6.78·10-2 vs 6.26·10-2  µGy·Bq-1 ·s-1 ). Similarly, the absorbed doses per decay in the r ~ 0.5 mm MALC for 177 Lu (2.41·10-2  µGy·Bq-1 ·s-1 ) and 131 I (2.46·10-2  µGy·Bq-1 ·s-1 ) are higher than for 90 Y (1.98·10-2  µGy·Bq-1 ·s-1 ). Furthermore, radionuclides releasing more energy per decay delivered absorbed dose more uniformly through the MALCs. Finally, when considering the radiopharmaceutical effective half-life, due to the biological half-life of rituximab being best matched by the physical half-life of 177 Lu and 131 I compared to 90 Y, the first two radionuclides delivered higher absorbed doses. CONCLUSION: In the simulated configurations, ß- emitters delivered higher and more uniform absorbed dose than Auger electron emitters. When considering radiopharmaceutical half-lives, 177 Lu and 131 I delivered absorbed doses higher than 90 Y. In view of real irradiation of MALCs, such a work may be useful to select suited radionuclides and to help explain the biological effects.

Medicaid Utilization and Spending among Homeless Adults in New Jersey: Implications for Medicaid-Funded Tenancy Support Services.

Policy Points Large numbers of homeless adults gained Medicaid coverage under the Affordable Care Act, increasing policymaker interest in strategies to improve care and reduce avoidable hospital costs for homeless populations. Compared with nonhomeless adult Medicaid beneficiaries, homeless adult beneficiaries have higher levels of health care needs, due in part to mental health issues and substance use disorders. Homeless adults are also more likely to visit the emergency department or require inpatient admissions. Emergency care and inpatient admissions may sometimes be avoided when individuals have high-quality community-based care and healthful living conditions. Offering tenancy support services that help homeless adults achieve stable housing may therefore be a cost-effective strategy for improving the health of this vulnerable population while reducing spending on avoidable health care interventions. Medicaid beneficiaries with disabling health conditions and more extensive histories of homelessness experience the most potentially avoidable health care interventions and spending, with the greatest opportunity to offset the cost of offering tenancy support benefits. CONTEXT: Following Medicaid expansion under the Affordable Care Act, the number of homeless adults enrolled in Medicaid has increased. This has spurred interest in developing Medicaid-funded tenancy support services (TSS) for homeless populations as a way to reduce Medicaid spending on health care for these individuals. An emerging body of evidence suggests that such TSS can reduce avoidable health care spending. METHODS: Drawing on linked Homeless Management Information System and Medicaid claims and encounter data, this study describes the characteristics of homeless adults who could be eligible for Medicaid TSS in New Jersey and compares their Medicaid utilization and spending patterns to matched nonhomeless beneficiaries. FINDINGS: More than 8,400 adults in New Jersey were estimated to be eligible for Medicaid TSS benefits in 2016, including approximately 4,000 living in permanent supportive housing, 800 formally designated as chronically homeless according to federal guidelines, 1,300 who were likely eligible for the chronically homeless designation, and over 2,000 who were at risk of becoming chronically homeless. Homeless adults in our study were disproportionately between the ages of 30 and 64 years, male, and non-Hispanic blacks. The homeless adults we studied also tended to have very high burdens of mental health and substance use disorders, including opioid-related conditions. Medicaid spending for a homeless beneficiary who was potentially eligible for TSS was 10% ($1,362) to 27% ($5,727) more than spending for a nonhomeless Medicaid beneficiary matched on demographic and clinical characteristics. Hospital inpatient and emergency department utilization accounted for at least three-fourths of "excess" Medicaid spending among the homeless groups. CONCLUSIONS: A large group of high-need Medicaid beneficiaries could benefit from TSS, and Medicaid funding for TSS could reduce avoidable Medicaid utilization and spending.

Health Care Utilization After Paraprofessional-administered Substance Use Screening, Brief Intervention, and Referral to Treatment: A Multi-level Cost-offset Analysis.

BACKGROUND: Authorities recommend universal substance use screening, brief intervention, and referral to treatment (SBIRT) for all (ie, universal) adult primary care patients. OBJECTIVE: The objective of this study was to examine long-term (24-mo) changes in health care utilization and costs associated with receipt of universal substance use SBIRT implemented by paraprofessionals in primary care settings. RESEARCH DESIGN: This study used a difference-in-differences design and Medicaid administrative data to assess changes in health care use among Medicaid beneficiaries receiving SBIRT. The difference-in-differences estimates were used in a Monte Carlo simulation to estimate potential cost-offsets associated with SBIRT. SUBJECTS: The treatment patients were Medicaid beneficiaries who completed a 4-question substance use screen as part of an SBIRT demonstration program between 2006 and 2011. Comparison Medicaid patients were randomly selected from matched clinics in Wisconsin. MEASURES: The study includes 4 health care utilization measures: outpatient days; inpatient length of stay; inpatient admissions; and emergency department admissions. Each outcome was assigned a unit cost based on mean Wisconsin Medicaid fee-for-service reimbursement amounts. RESULTS: We found an annual increase of 1.68 outpatient days (P=0.027) and a nonsignificant annual decrease in inpatient days of 0.67 days (P=0.087) associated with SBIRT. The estimates indicate that the cost of a universal SBIRT program could be offset by reductions in inpatient utilization with an annual net cost savings of $782 per patient. CONCLUSIONS: Paraprofessional-delivered universal SBIRT is likely to yield health care cost savings and is a cost-effective mechanism for integrating behavioral health services in primary care settings.

Anxiety sensitivity and smoking outcome expectancies among Spanish-speaking Latinx adult smokers.

Smoking is among the most important health behaviors linked to premature death and disability among the Latinx population. Yet there is limited understanding of whether transdiagnostic factors like anxiety sensitivity may help explain smoking expectancies among Spanish-speaking Latinx smokers. The present investigation evaluated anxiety sensitivity in regard to smoking outcome expectancy factors among a large sample of adult Latinx smokers. Participants were 363 Spanish-speaking Latinx daily smokers (58.7% female, Mage = 33.3 years, SD = 9.8). As expected, anxiety sensitivity was significantly related to expectancies of negative reinforcement and negative personal consequences. Anxiety sensitivity also was a significant predictor of smoking expectancies of appetite control and positive reinforcement. The present study provides novel empirical evidence that anxiety sensitivity explains a notable degree of variance in smoking outcome expectancies over the variance accounted for by a range of theoretically relevant covariates among Latinx smokers. These results highlight the clinical utility in assessing anxiety sensitivity among Latinx smokers and focusing greater attention on this construct in efforts to better understand cognitive-based smoking expectancies among this population. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Urban Minority Community Safety and its Impact on Physical Activity: The Center for Promoting Health and Health Equity-Racial and Ethnic Approaches to Community Health (CPHHE-REACH) Initiative.

BACKGROUND/PURPOSE: Daily physical activity is known to improve personal health and well-being and can often be influenced by one's living environment. A qualitative secondary data analysis of a focus group study, performed by the Creighton University Center for Promoting Health and Health Equity (CPHHE) - Racial and Ethnic Approaches to Community Health (REACH), assesses behavioral changes in individuals who participated in newly established physical activities in faith-based organizations, local residential towers, and the local community health center. METHOD: Applying thematic analysis within the Health Belief Model framework, the investigators further investigated the relationships between its constructs and levels of physical activity in urban minority neighborhoods. RESULTS: Results indicated that residents who perceived their neighborhoods as unsafe had a negative attitude toward physical activity. In contrast, building social relationships and camaraderie that enhanced social cohesion were major themes that increased participants' self-efficacy, resulting in positive changes in health behavior. CONCLUSION: Community partnerships had a positive impact on motivating individuals to live healthier lifestyles. An interesting concept was that of community efficacy, which reflects the community's confidence in its ability to generate behavioral changes in individuals.

No. 373-Cervical Insufficiency and Cervical Cerclage.

OBJECTIVE: The purpose of this guideline is to provide a framework that clinicians can use to determine which women are at greatest risk of having cervical insufficiency and in which set of circumstances a cerclage is of potential value. EVIDENCE: Published literature was retrieved through searches of PubMed or Medline, CINAHL, and The Cochrane Library in 2018 using appropriate controlled vocabulary (e.g., uterine cervical incompetence) and key words (e.g., cervical insufficiency, cerclage, Shirodkar, cerclage, McDonald, cerclage, abdominal, cervical length, mid-trimester pregnancy loss). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date or language restrictions. Searches were updated on a regular basis and incorporated in the guideline to June 2018. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. VALUES: The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care.

Management of Diabetes Mellitus Before 18F-Fluorodeoxyglucose PET/CT: A Nationwide Patient-Centered Assessment of Approaches to Examination Preparation.

PURPOSE: The aim of this study was to perform, from the patient's point of view, a nationwide assessment of nuclear medicine practices regarding diabetic management before 18F-fluorodeoxyglucose (FDG) PET/CT for oncologic indications. METHODS: This prospective observational study was exempt from institutional review board oversight. Sixty-five nuclear medicine scheduling lines (33 academic, 32 private practice, 12-17 in each of the five US regions) were called using a prewritten script under the guise of a nonexpert patient's family member about scheduling a patient with diabetes with "cancer" for FDG PET/CT. Each center was called three times on three different days. The following data were collected: (1) blood glucose threshold for rescheduling an examination, (2) when or if to stop various medications, (3) fasting requirements, and (4) time-of-day scheduling preferences. Withheld information was not specifically requested. Descriptive statistics were calculated. RESULTS: There were 195 phone calls (mean duration, 2.9 min; range, 2-6 min). Relevant information was often withheld; withholding rates were as follows: blood glucose threshold, 71% (138 of 195); short-acting insulin instructions, 30% (59 of 195); long-acting insulin instructions, 99% (193 of 195); metformin instructions, 88% (179 of 195); fasting duration, 37% (72 of 195); and time-of-day scheduling preference, 91% (177 of 195). Mean provided data were as follows: blood glucose threshold, 195 mg/dL (range, 150-210 mg/dL); short-acting insulin withholding, 4.9 hours (range, 4-8 hours); long-acting insulin withholding, 12 hours (range, 12-24 hours); fasting duration, 5 hours (range, 4-8 hours); and preferred examination time, 91% (177 of 195). When specified (n = 18), morning scheduling was preferred (8% [15 of 195] versus 2% [3 of 195]). CONCLUSIONS: Diabetes-specific information is commonly withheld by nuclear medicine call centers throughout the United States when discussing oncologic FDG PET/CT despite local and national policies indicating its importance.

Identifying How Patient Portals Impact Communication in Oncology.

Patient portals are becoming widespread throughout health-care systems. Initial research has demonstrated that they positively impact patient-provider communication and patients' health knowledge, but little is known about the impact of patient portals in the cancer setting, where highly complex and uncertain medical data are available for patients to view. To better understand communicative behaviors and perceptions of the patient portal and how it is utilized in oncology, in-depth, semi-structured interviews were conducted with 48 participants: 35 patients and 13 oncologists. Thematic analysis identified that portals help to enhance participation during in-person consultations, increase patients' self-advocacy, and build rapport with providers. However, patients' comfort level with reviewing information via the portal depended upon the severity of the test. Oncologists worried about patient anxiety and widening health disparities, but acknowledged that the portal can motivate them to expedite communication about laboratory and scan results. As patient portals become more widely used in all medical settings, oncologists should become more engaged with how patients are viewing their medical information and consider the portal within the framework of patient-centered care by valuing patients' communication preferences.

Anxiety sensitivity and smoking among Spanish-speaking Latinx smokers.

Despite the documented health disparities for smoking among the Latinx population, there is limited understanding of transdiagnostic constructs that may help explain smoking among Spanish-speaking Latinx smokers. The present study examined one promising transdiagnostic factor, anxiety sensitivity (fear of anxiety and related sensations), in relation to cigarette dependence, perceived barriers for quitting, and severity of problems experienced when trying to quit among a large sample of Latinx smokers. Participants were 367 Spanish-speaking Latinx daily smokers (59.1% female, Mage = 33.20 years, SD = 11.81). As hypothesized, anxiety sensitivity was significantly related to the severity of cigarette dependence, perceived barriers for quitting, and problems when trying to quit. Inspection of the lower-order dimensions of anxiety sensitivity indicated that Physical Concerns was significantly related to cigarette dependence whereas Cognitive Concerns was associated with greater perceived barriers for quitting and severity of problems experienced during past quit attempts. The present study provides novel empirical evidence that anxiety sensitivity is related to a moderate, yet clinically meaningful, proportion of the variance in cigarette dependence, perceived barriers for quitting, and problems experienced during quit attempts. These findings underscore the value of examining anxiety sensitivity among Latinx smokers and focusing greater attention on this construct in efforts to reduce or quit smoking among this population.

Multi-method assessment of distress tolerance and smoking-related factors among adult daily smokers.

Although distress tolerance (DT) is associated with smoking lapse and relapse outcomes, few studies have conducted a rigorous assessment of DT across domain and method in the context of acute abstinence. In a human laboratory-based study of 106 adult daily smokers, we examined between multiple indices of DT and smoking lapse, withdrawal processes, and motivation to quit. We expected that low DT would be associated with shorter latency to smoke, greater withdrawal severity, and lower motivation to quit. Following a smoking abstinence period (≥ 6 hr deprived), participants completed an assessment battery including both behavioral (mirror-tracing, serial addition, cold pressor, and breath-holding tasks) and self-report measures of DT (general and smoking-specific), withdrawal processes (craving, negative affect, and positive affect), and motivation to quit. Latency to smoke (range = 0-50 min) was assessed in a laboratory analogue task in which delaying smoking was monetarily rewarded. Behavioral and self-report DT indices displayed only modest intercorrelations, indicating different facets of this construct by domain and method of assessment. Tolerance of physical pain was uniquely associated with smoking choice. Both self-report DT measures were associated with abstinence-induced increases in negative affect, while only smoking-specific DT was positively associated with craving. Results are discussed within the context of guiding targeted behavioral interventions. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

YMCA exercise intervention to augment smoking cessation treatment in adults with high anxiety sensitivity: Study protocol for a randomized controlled trial.

Extant evidence suggests that exercise can reduce anxiety related vulnerability factors, such as anxiety sensitivity (AS), or fear of bodily sensations related to anxiety, that negatively impact smoking cessation outcomes. Building upon emerging evidence supporting the efficacy of exercise as an aid for smoking cessation in adults with high AS, we are conducting a trial to examine the efficacy and feasibility of this clinical application when implemented in a community setting. Partnering with the YMCA, this study aims to enroll 150 adults in a standard smoking cessation protocol (i.e. counseling and nicotine replacement therapy) and randomly assign them to either 15 weeks of programmed vigorous-intensity or low-intensity exercise. Smoking abstinence data will be collected up to 6 months following the quit attempt.

Testing the Feasibility of a Mindfulness-Based Intervention With Underserved Adolescents at Risk for Depression.

This study tested the feasibility, acceptability, and preliminary effects of a mindfulness-based intervention with at-risk adolescents from a predominantly Hispanic/Latino community. Seven adolescents (57% female, 85% Hispanic/Latino) completed the mindfulness-based intervention, demonstrating feasibility, and reported acceptability as well as sustained improvements in depressive symptoms, perceived stress, and self-esteem.

Impact of free access to leisure facilities and community outreach on inequalities in physical activity: a quasi-experimental study.

BACKGROUND: There are large inequalities in levels of physical activity in the UK, and this is an important determinant of health inequalities. Little is known about the effectiveness of community-wide interventions to increase physical activity and whether effects differ by socioeconomic group. METHODS: We conducted interrupted time series and difference-in-differences analyses using local administrative data and a large national survey to investigate the impact of an intervention providing universal free access to leisure facilities alongside outreach and marketing activities in a deprived local authority area in the northwest of England. Outcomes included attendances at swimming and gym sessions, self-reported participation in gym and swim activity and any physical activity. RESULTS: The intervention was associated with a 64% increase in attendances at swimming and gym sessions (relative risk 1.64, 95% CI 1.43 to 1.89, P<0.001), an additional 3.9% of the population participating in at least 30 min of moderate-intensity gym or swim sessions during the previous four weeks (95% CI 3.6 to 4.1) and an additional 1.9% of the population participating in any sport or active recreation of at least moderate intensity for at least 30 min on at least 12 days out of the last four weeks (95% CI 1.7 to 2.1). The effect on gym and swim activity and overall levels of participation in physical activity was significantly greater for the more disadvantaged socioeconomic group. CONCLUSIONS: The study suggests that removing user charges from leisure facilities in combination with outreach and marketing activities can increase overall population levels of physical activity while reducing inequalities.