Rapid Enrollment Growth In 'Look-Alike' Dual-Eligible Special Needs Plans: A Threat To Integrated Care.

Policy makers are increasingly investing in efforts to better integrate Medicare and Medicaid services for people who are eligible for both programs, including expanding Dual-Eligible Special Needs Plans (D-SNPs). In recent years, however, a potential threat to integration has emerged in the form of D-SNP "look-alike" plans, which are conventional Medicare Advantage plans that are marketed toward and primarily enroll dual eligibles but are not subject to federal regulations requiring integrated Medicaid services. To date, limited evidence exists documenting national enrollment trends in look-alike plans or the characteristics of dual eligibles in these plans. We found that look-alike plans experienced rapid enrollment growth among dual eligibles during the period 2013-20, increasing from 20,900 dual eligibles across four states to 220,860 dual eligibles across seventeen states, for an elevenfold increase. Nearly one-third of dual eligibles in look-alike plans were previously in integrated care programs. Compared with D-SNPs, look-alike plans were more likely to enroll dual eligibles who were older, Hispanic, and from disadvantaged communities. Our findings suggest that look-alike plans have the potential to compromise national efforts to integrate care delivery for dual eligibles, including vulnerable subgroups who may benefit the most from integrated coverage.

Prediction of disease comorbidity using explainable artificial intelligence and machine learning techniques: A systematic review.

OBJECTIVE: Disease comorbidity is a major challenge in healthcare affecting the patient's quality of life and costs. AI-based prediction of comorbidities can overcome this issue by improving precision medicine and providing holistic care. The objective of this systematic literature review was to identify and summarise existing machine learning (ML) methods for comorbidity prediction and evaluate the interpretability and explainability of the models. MATERIALS AND METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) framework was used to identify articles in three databases: Ovid Medline, Web of Science and PubMed. The literature search covered a broad range of terms for the prediction of disease comorbidity and ML, including traditional predictive modelling. RESULTS: Of 829 unique articles, 58 full-text papers were assessed for eligibility. A final set of 22 articles with 61 ML models was included in this review. Of the identified ML models, 33 models achieved relatively high accuracy (80-95%) and AUC (0.80-0.89). Overall, 72% of studies had high or unclear concerns regarding the risk of bias. DISCUSSION: This systematic review is the first to examine the use of ML and explainable artificial intelligence (XAI) methods for comorbidity prediction. The chosen studies focused on a limited scope of comorbidities ranging from 1 to 34 (mean = 6), and no novel comorbidities were found due to limited phenotypic and genetic data. The lack of standard evaluation for XAI hinders fair comparisons. CONCLUSION: A broad range of ML methods has been used to predict the comorbidities of various disorders. With further development of explainable ML capacity in the field of comorbidity prediction, there is a significant possibility of identifying unmet health needs by highlighting comorbidities in patient groups that were not previously recognised to be at risk for particular comorbidities.

Enrollment And Characteristics Of Dual-Eligible Medicare And Medicaid Beneficiaries In Integrated Care Programs.

Integrated care programs (ICPs) are meant to make Medicare and Medicaid coverage for dual-eligible beneficiaries work more seamlessly. Evidence is limited on ICP enrollment trends and the characteristics of dual-eligible beneficiaries who enroll in these programs-specifically, the Program of All-Inclusive Care for the Elderly, Medicare Advantage (MA) Fully Integrated Dual-Eligible Special Needs Plans, and state demonstration Medicare-Medicaid plans. Using national data, we evaluated changes in ICP enrollment between 2013 and 2020 and compared the demographic characteristics of beneficiaries in these programs relative to the characteristics of beneficiaries not in them. The proportion of dual-eligible beneficiaries in ICPs increased from 2.0 percent in 2013 to 9.4 percent in 2020. However, nonintegrated or partially integrated coordination-only MA plans experienced the plurality of growth in enrollment of dual-eligible beneficiaries. Relative to non-ICP fee-for-service Medicare, beneficiaries in ICPs were more likely to be Black and Hispanic versus White and were less likely to be rural, younger, or disabled. Policy makers should diligently monitor growth in ICPs and less integrated dual-eligible plans in MA while also evaluating their impact on equity, spending, and quality of care.

How does the dental benefits act encourage Australian families to seek and utilise oral health services?

BACKGROUND: This study aimed to analyse the content of the Dental Benefits Act 2008 as a foundation for the Child Dental Benefits Schedule (CDBS) to determine how the Act encourages Australian families to seek and utilise oral health services. METHODS: This was a qualitative narrative document analysis conducted in 2022. Data was collected by searching formal websites for retrieving documents that reported the Australian Dental Benefits Act. The eligibility of the retrieved documents was assessed based on authenticity, credibility, representativeness, and meaningfulness of the data. A seven-steps procedure was applied for framework analysis. RESULTS: The content of the Dental Benefits Act 2008 provides directions on the three categories of operational, collective, and constitutional rules. Operational rules at the level of oral health providers and the population, as the service end users, can be demonstrated as rules in use in a mutual interaction with the collective and constitutional rules. The consequence of governing the rules at the community level can easily define how the oral health services are provided and utilised. The response is sent to the government level for better regulation of oral health service delivery and utilisation. Then, with interaction and advocacy with the diverse range of stakeholders and interdisciplinary partnerships, with community groups, non-government sectors and councils, the rules can be transformed, adopted, monitored, and enforced. Another mechanism of response has occurred at the providers' and users' level and to the operational rules to community groups and stakeholders via advertising and promoting the utilisation and provision of oral health services. CONCLUSION: This study integrates the perspective of politicians with those of policy makers to reconsider the role and significance of the rules based on the triple collaborations among oral health users and oral service providers, the community, and the stakeholders as well as the government. A comprehensive attention is still needed in future revisions of the Dental Benefits Act 2008 according to the contextual factors, socioeconomic and geographical attributes of the population for better implementation of de facto rules and more effective outcomes of the interventions. It is recommended that further research be undertaken utilising a mix-method approach for a holistic view prior to further revisions of the Act or proposal of probable upcoming schemes.

Association of the Comprehensive Care for Joint Replacement Model With Disparities in the Use of Total Hip and Total Knee Replacement.

Importance: The Comprehensive Care for Joint Replacement (CJR) model is Medicare's mandatory bundled payment reform to improve quality and spending for beneficiaries who need total hip replacement (THR) or total knee replacement (TKR), yet it does not account for sociodemographic risk factors such as race/ethnicity and income. Results of this study could be the basis for a Medicare payment reform that addresses inequities in joint replacement care. Objective: To examine the association of the CJR model with racial/ethnic and socioeconomic disparities in the use of elective THR and TKR among older Medicare beneficiaries after accounting for the population of patients who were at risk or eligible for these surgical procedures. Design, Setting, and Participants: This cohort study used the 2013 to 2017 national Medicare data and multivariable logistic regressions with triple-differences estimation. Medicare beneficiaries who were aged 65 to 99 years, entitled to Medicare, alive at the end of the calendar year, and residing either in the 67 metropolitan statistical areas (MSAs) mandated to participate in the CJR model or in the 104 control MSAs were identified. A subset of Medicare beneficiaries with a diagnosis of arthritis underwent THR or TKR. Data were analyzed from March to December 2020. Exposures: Implementation of the CJR model in 2016. Main Outcomes and Measures: Outcomes were separate binary indicators for whether a beneficiary underwent THR or TKR. Key independent variables were MSA treatment status, pre- or post-CJR model implementation phase, combination of race/ethnicity (non-Hispanic White, non-Hispanic Black, and Hispanic beneficiaries) and dual eligibility, and their interactions. Logistic regression models were used to control for patient characteristics, MSA fixed effects, and time trends. Results: The 2013 cohort included 4 447 205 Medicare beneficiaries, of which 2 025 357 (45.5%) resided in MSAs with the CJR model. The cohort's mean (SD) age was 77.18 (7.95) years, and it was composed of 2 951 140 female (66.4%), 3 928 432 non-Hispanic White (88.3%), and 657 073 dually eligible (14.8%) beneficiaries. Before the CJR model implementation, rates were highest among non-Hispanic White non-dual-eligible beneficiaries at 1.25% (95% CI, 1.24%-1.26%) for THR use and 2.28% (95% CI, 2.26%-2.29%) for TKR use in MSAs with CJR model. Compared with MSAs without the CJR model and the analogous race/ethnicity and dual-eligibility group, the CJR model was associated with a 0.10 (95% CI, 0.05-0.15; P < .001) percentage-point increase in TKR use for non-Hispanic White non-dual-eligible beneficiaries, a 0.11 (95% CI, 0.004-0.21; P = .04) percentage-point increase for non-Hispanic White dual-eligible beneficiaries, a 0.15 (95% CI, -0.29 to -0.01; P = .04) percentage-point decrease for non-Hispanic Black non-dual-eligible beneficiaries, and a 0.18 (95% CI, -0.34 to -0.01; P = .03) percentage-point decrease for non-Hispanic Black dual-eligible beneficiaries. These CJR model-associated changes in TKR use were 0.25 (95% CI, -0.40 to -0.10; P = .001) percentage points lower for non-Hispanic Black non-dual-eligible beneficiaries and 0.27 (95% CI, -0.45 to -0.10; P = .002) percentage points lower for non-Hispanic Black dual-eligible beneficiaries compared with the model-associated changes for non-Hispanic White non-dual-eligible beneficiaries. No association was found between the CJR model and a widening of the THR use gap among race/ethnicity and dual eligibility groups. Conclusions and Relevance: Results of this study indicate that the CJR model was associated with a modest increase in the already substantial difference in TKR use among non-Hispanic Black vs non-Hispanic White beneficiaries; no difference was found for THR. These findings support the widespread concern that payment reform has the potential to exacerbate disparities in access to joint replacement care.

Biochemical predictors of structural hypothalamus-pituitary abnormalities detected by magnetic resonance imaging in men with secondary hypogonadism.

PURPOSE: Organic conditions underlying secondary hypogonadism (SH) may be ascertained by magnetic resonance imaging (MRI) of the hypothalamic-pituitary region that could not be systematically proposed to each patient. Based upon limited evidence, the Endocrine Society (ES) guidelines suggest total testosterone (T) < 5.2 nmol/L to identify patients eligible for MRI. The study aims to identify markers and their best threshold value predicting pathological MRI findings in men with SH. METHODS: A consecutive series of 609 men seeking medical care for sexual dysfunction and with SH (total T < 10.5 nmol/L and LH ≤ 9.4 U/L) was retrospectively evaluated. An independent cohort of 50 men with SH was used as validation sample. 126 men in the exploratory sample and the whole validation sample underwent MRI. RESULTS: In the exploratory sample, patients with pathological MRI findings (n = 46) had significantly lower total T, luteinizing hormone (LH), follicle stimulating hormone (FSH) and prostate specific antigen (PSA) than men with normal MRI (n = 80). Receiver Operating Characteristics analysis showed that total T, LH, FSH and PSA are accurate in identifying men with pathologic MRI (accuracy: 0.62-0.68, all p < 0.05). The Youden index was used to detect the value with the best performance, corresponding to total T 6.1 nmol/L, LH 1.9 U/L, FSH 4.2 U/L and PSA 0.58 ng/mL. In the validation cohort, only total T ≤ 6.1 nmol/L and LH ≤ 1.9 U/L were confirmed as significant predictors of pathologic MRI. CONCLUSION: In men with SH, total T ≤ 6.1 nmol/L or LH ≤ 1.9 U/L should arise the suspect of hypothalamus/pituitary structural abnormalities, deserving MRI evaluation.

Potential Disparities by Sex and Race or Ethnicity in Lung Cancer Screening Eligibility Rates.

BACKGROUND: Criteria for low-dose CT scan lung cancer screening vary across guidelines. Knowledge of the eligible pool across demographic groups can enable policy and programmatic decision-making, particularly for disproportionately affected populations. RESEARCH QUESTION: What are the eligibility rates for low-dose CT scan screening according to sex and race or ethnicity and how do these rates relate to corresponding lung cancer incidence rates? STUDY DESIGN AND METHODS: This was a cross-sectional study using data from the 2015 National Health Interview Survey adult and cancer control supplement files. In addition to eligibility rates, the ratio of the eligibility rate to the lung cancer incidence rate in a given population group (eligibility to incidence [E-I] ratio) also was determined. Guidelines assessed were: Centers for Medicare and Medicaid Services, National Comprehensive Cancer Network, and US Preventive Services Task Force current or with expansion of age and smoking or quit thresholds. We also assessed a risk model (PLCOM2012 risk model). RESULTS: Total numbers eligible based on current guidelines ranged from 8.3 to 13.3 million, representing 8.3% to 13.4% of the US population 50 to 80 years of age, and up to 17.5 million with expanded criteria. Overall eligibility rates on average were about 10 percentage points higher for men than women. For both men and women, and both overall and among ever smokers, non-Hispanic Whites had the highest eligibility rates across all guidelines, followed generally by non-Hispanic Blacks, and then Asians and Hispanics. Among both men and women, non-Hispanic Whites had the highest E-I ratios across all guidelines; non-Hispanic Black men had higher lung cancer incidence, but 30% to 50% lower E-I ratios, than non-Hispanic White men. INTERPRETATION: Screening eligibility rates vary widely across guidelines, with disparities evident in E-I ratios, including among non-Hispanic Black men, despite higher lung cancer burden. Consideration of smoking duration in risk assessment criteria may address current disparities.

Preparing for PrEP; the cost of delaying universal access in England.

OBJECTIVES: Pre-exposure prophylaxis (PrEP) is not commissioned within National Health Service (NHS) England. Individuals can access it privately online or by enrolment into a clinical trial. We established a list of individuals not enrolled in trials, awaiting PrEP. In response to the observation that patients awaiting PrEP trials were being referred with newly diagnosed HIV, we aimed to measure attendance, incident HIV, STI acquisition and missed opportunities for prevention. METHODS: The search was conducted for patients on the list from November 2017 to November 2019. We examined the electronic clinical records of those on the list and extracted demographic information, STI and HIV diagnoses. In addition, for those diagnosed with HIV, we reviewed risk factors including chemsex and prior postexposure prophylaxis. RESULTS: There were 1073 patients on list, and 520 (48.6%) were still awaiting recruitment in a PrEP trial. Eight (0.75%) had an enrolment appointment booked while 200 (18.64%) had been contacted and deemed ineligible according to PrEP trial criteria. 45 (32.15%) had not responded to contact. We identified 15 new HIV infections in patients awaiting PrEP. Of these, 9/15 (60.00%) did not meet eligibility criteria at point of contact, though had been eligible at first referral. CONCLUSION: It is unacceptable that 15 patients acquired HIV while waiting. The individual lifetime cost of treating HIV is estimated at £360 800(1). This equals £5 412 000 for these 15 infections notwithstanding the psychological and physical burden. We advocate the immediate role out of universal PrEP for those who need it on the NHS. While this decision is delayed, harm is coming to those waiting. Wider provision of PrEP may encourage increased attendance, but must consider additional resources to accommodate added visits. We are relieved that at the point of final submission (21 March 2020) NHS England have recently announced funding of PrEP for eligible patients from, further details are pending.

Inclusion of pregnant women in COVID-19 treatment trials: a review and global call to action.

Inclusion of pregnant women in COVID-19 clinical trials would allow evaluation of effective therapies that might improve maternal health, pregnancy, and birth outcomes, and avoid the delay of developing treatment recommendations for pregnant women. We explored the inclusion of pregnant women in treatment trials of COVID-19 by reviewing ten international clinical trial registries at two timepoints in 2020. We identified 155 COVID-19 treatment studies of non-biological drugs for the April 7-10, 2020 timepoint, of which 124 (80%) specifically excluded pregnant women. The same registry search for the July 10-15, 2020 timepoint, yielded 722 treatment studies, of which 538 (75%) specifically excluded pregnant women. We then focused on studies that included at least one of six drugs (remdesivir, lopinavir-ritonavir, interferon beta, corticosteroids, chloroquine and hydroxychloroquine, and ivermectin) under evaluation for COVID-19. Of 176 such studies, 130 (74%) listed pregnancy as an exclusion criterion. Of 35 studies that evaluated high-dose vitamin treatment for COVID-19, 27 (77%) excluded pregnant women. Despite the surge in treatment studies for COVID-19, the proportion excluding pregnant women remains consistent. Exclusion was not well justified as many of the treatments being evaluated have no or low safety concerns during pregnancy. Inclusion of pregnant women in clinical treatment trials is urgently needed to identify effective COVID-19 treatment for this population.

REDUCE-IT Eligibility and Preventable Cardiovascular Events in the US Population (from the National Health and Nutrition Examination Survey [NHANES]).

The reduction of cardiovascular events with icosapent ethyl-intervention (REDUCE-IT) trial showed in persons with prior cardiovascular disease (CVD) or diabetes mellitus (DM) that icosapent ethyl (IPE) reduced CVD events by 25%. We projected the preventable initial and total CVD events if REDUCE-IT trial eligibility criteria were applied to US adults. We identified US adults with available REDUCE-IT inclusion criteria from NHANES Surveys 1999-2016 and estimated primary (CVD death, nonfatal myocardial infarction, stroke, revascularization, or unstable angina) and secondary composite (CVD death, nonfatal MI or stroke) events using REDUCE-IT published event rates in the IPE and placebo groups, the difference being the number of preventable events. From 11,445 adults aged ≥45 years (representing 111.1 million [M]), a total of 319 persons (3.0 M) fit key REDUCE-IT eligibility criteria: triglycerides of 135 to 499 mg/dL, HbA1c <10%, blood pressure <200/100 mm Hg, and on a statin with LDL-C of 40 to 99 mg/dL. 63% had prior CVD and 37% had DM + ≥1 risk factor (primary prevention cohort). If these persons are given IPE for the REDUCE-IT median trial period of 4.9 years, we estimated preventing a total 349,817 (71,391/year) primary CVD outcomes of which 146,011 (29,798/year) were initial events. Most (24,151) preventable events were from the secondary prevention cohort. Using FDA eligibility criteria, an estimated 4.6 million persons would be eligible for IPE, with 60,544 preventable primary CVD outcomes annually from REDUCE-IT USA event rates. In conclusion, many CVD events in US adults with known CVD or DM and well-controlled LDL-C on statin therapy can be prevented with IPE.

Clinician's Perception of Practice Changes for Stroke During the COVID-19 Pandemic.

BACKGROUND: Approach to acute cerebrovascular disease management has evolved in the past few months to accommodate the rising needs of the 2019 novel coronavirus (COVID-19) pandemic. In this study, we investigated the changes in practices and policies related to stroke care through an online survey. METHODS: A 12 question, cross-sectional survey targeting practitioners involved in acute stroke care in the US was distributed electronically through national society surveys, social media and personal communication. RESULTS: Respondants from 39 states completed 206 surveys with the majority (82.5%) from comprehensive stroke centers. Approximately half stated some change in transport practices with 14 (7%) reporting significant reduction in transfers. Common strategies to limit healthcare provider exposure included using personal protective equipment (PPE) for all patients (127; 63.5%) as well as limiting the number of practitioners in the room (129; 64.5%). Most respondents (81%) noted an overall decrease in stroke volume. Many (34%) felt that the outcome or care of acute stroke patients had been impacted by COVID-19. This was associated with a change in hospital transport guidelines (OR 1.325, P = 0.047, 95% CI: 1.004-1.748), change in eligibility criteria for IV-tPA or mechanical thrombectomy (MT) (OR 3.146, P = 0.052, 95% CI: 0.988-10.017), and modified admission practices for post IV-tPA or MT patients (OR 2.141, P = 0.023, 95% CI: 1.110-4.132). CONCLUSION: Our study highlights a change in practices and polices related to acute stroke management in response to COVID-19 which are variable among institutions. There is also a reported reduction in stroke volume across hospitals. Amongst these changes, updates in hospital transport guidelines and practices related to IV-tPA and MT may affect the perceived care and outcome of acute stroke patients.

Estimating the number of preventable cardiovascular disease events in the United States using the EMPA-REG OUTCOME trial results and National Health and Nutrition Examination Survey.

AIM: We examined eligibility and preventable cardiovascular disease events in US adults with diabetes mellitus from the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME). METHODS: We identified adults with diabetes mellitus eligible for EMPA-REG OUTCOME based on trial eligibility criteria available from the National Health and Nutrition Examination Surveys, 2007-2016. We estimated composite cardiovascular disease endpoints, as well as all-cause deaths, death from cardiovascular disease and hospitalizations for heart failure from trial treatment and placebo event rates, the difference indicating the preventable events. RESULTS: Among 29,629 US adults aged ⩾18 years (representing 231.9 million), 4672 (27.3 million) had diabetes mellitus, with 342 (1.86 million) meeting eligibility criteria of EMPA-REG OUTCOME. We estimated from trial primary endpoint event rates of 10.5% and 12.1% in the empagliflozin and placebo groups, respectively, that based on the 'treatment' of our 1.86 million estimated EMPA-REG OUTCOME eligible subjects, 12,066 (95% confidence interval: 10,352-13,780) cardiovascular disease events could be prevented annually. Estimated annual preventable deaths from any cause, cardiovascular causes and hospitalizations from heart failure were 17,078 (95% confidence interval: 14,652-19,504), 14,479 (95% confidence interval: 12,422-16,536) and 9467 (95% confidence interval: 8122-10,812), respectively. CONCLUSION: Empagliflozin, if provided to EMPA-REG OUTCOME eligible US adults, may prevent many cardiovascular disease events, cardiovascular and total deaths, as well as heart failure hospitalizations.

LEADER Trial Eligibility and Preventable Cardiovascular Events in US Adults with Diabetes: the National Health and Nutrition Examination Surveys 2007-2016.

PURPOSE: The Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial showed the cardiovascular disease (CVD) benefits of liraglutide therapy among patients with type 2 diabetes mellitus (T2DM). We applied this trial to US adults with T2DM in terms of eligibility and preventable CVD events. METHODS: We included US adults with T2DM from the National Health and Nutrition Examination Survey (NHANES) 2007-2016. Eligibility criteria from LEADER primary and secondary prevention cohorts were applied to determine potentially eligible US adults. We estimated the number of primary composite and secondary CVD endpoints that would occur based on LEADER treated and placebo published event rates, with the difference indicating the number of preventable events. RESULTS: Among 4672 (projected to 27.3 million [M]) adults we identified with T2DM, we estimated 800 (4.2 million) (15.4%) to fit LEADER eligibility criteria, including 205 (0.9 M) primary prevention 595 (3.3 M) secondary prevention subjects. Compared to LEADER trial participants, our sample had higher proportions of women and minorities, prior angina, chronic kidney disease, and lipid-lowering medication use. We estimated 21,209 primary composite CVD events, 29,691 extended CVD composite outcomes, 16,967 all-cause deaths, 16,967 cardiovascular deaths, 12,725 myocardial infarctions, and 12,725 microvascular events would be prevented annually if our eligible T2DM subjects were on liraglutide. CONCLUSION: Liraglutide may prevent many fatal and non-fatal CVD events if provided to US adults meeting LEADER eligibility criteria. More efforts are needed to educate the healthcare providers on the CVD benefits from newer diabetes therapies, including liraglutide.

A Retrospective Analysis of Clinical Trial Accrual of Patients Presented in a Multidisciplinary Tumor Board at a Tertiary Health Care Center and Associated Barriers.

INTRODUCTION: Cancer clinical trial accruals have been historically low and are affected by several factors. Multidisciplinary Tumor Board Meetings (MTBM) are conducted regularly and immensely help to devise a comprehensive care plan including discussions about clinical trial availability and eligibility. OBJECTIVES: To evaluate whether patient discussion at MTBM was associated with a higher consent rate for clinical trials at a single tertiary care center. METHODS: Institutional electronic medical records (EMR) and clinical trials management system (OnCore) were queried to identify all new patient visits in oncology clinics, consents to clinical trials, and MTBM notes between January 1, 2011 and December 31, 2015. The association between MTBM discussion and subsequent clinical trial enrollment within 16 weeks of the new patient visit was evaluated using a χ2 test. RESULTS: Between January 1, 2011 and December 31, 2015, 11,794 new patients were seen in oncology clinics, and 2,225 patients (18.9%) were discussed at MTBMs. MTBM discussion conferred a higher rate of subsequent clinical trial consent within 16 weeks following the patient's first consultation in an oncology clinic: 4.1% for those who were discussed at a MTBM compared to 2.8% for those not discussed (p < 0.01). CONCLUSIONS: This study provides evidence that MTBMs may be effective in identifying patients eligible for available clinical trials by reviewing eligibility criteria during MTBM discussions. We recommend discussion of all new patients in MTBM to improve the quality of care provided to those with cancer and enhanced clinical trial accrual.

Prevalence of potential candidates for electric-acoustic stimulation implant in a hearing-impaired population.

OBJECTIVE: To estimate the prevalence of potential electric-acoustic stimulation (EAS) implant candidates in a hearing-impaired population through a review of auditory examinations. METHODS: In total, 7356 patients underwent audiometric examination in our department between 2011 and 2014. The prevalence of patients meeting the audiometric criteria for EAS and standard cochlear implant (CI) was assessed. RESULTS: The percentage of EAS implant candidates meeting the pure-tone audiometric criteria was 0.71% (n=34) among the hearing-impaired individuals (n=4758) examined in our department, whereas 2.52% (n=120) met the criteria for standard CI. Among the 34 EAS implant candidates, 2 individuals (5.83%) received EAS implant surgery after approval of the EAS device in Japan. CONCLUSIONS: There was a lower prevalence of EAS implant candidates than standard CI candidates. Nevertheless, healthcare professionals should carefully examine the audiograms of patients with high frequency hearing loss with regard to meeting the indication criteria for EAS implant. This will enable patients to gain access to adequate information relating to further examinations and treatment options.

Simplified clinical algorithm for identifying patients eligible for same-day HIV treatment initiation (SLATE): Results from an individually randomized trial in South Africa and Kenya.

BACKGROUND: The World Health Organization recommends "same-day" initiation of antiretroviral therapy (ART) for HIV patients who are eligible and ready. Identifying efficient, safe, and feasible procedures for determining same-day eligibility and readiness is now a priority. The Simplified Algorithm for Treatment Eligibility (SLATE) study evaluated a clinical algorithm that allows healthcare workers to determine eligibility for same-day treatment and to initiate ART at the patient's first clinic visit. METHODS AND FINDINGS: SLATE was an individually randomized trial at three outpatient clinics in urban settlements in Johannesburg, South Africa and three hospital clinics in western Kenya. Adult, nonpregnant, HIV-positive, ambulatory patients presenting for any HIV care, including HIV testing, but not yet on ART were enrolled and randomized to the SLATE algorithm arm or standard care. The SLATE algorithm used four screening tools-a symptom self-report, medical history questionnaire, physical examination, and readiness assessment-to ascertain eligibility for same-day initiation or refer for further care. Follow-up was by record review, and analysis was conducted by country. We report primary outcomes of 1) ART initiation ≤28 days and 2) initiation ≤28 days and retention in care ≤8 months of enrollment. From March 7, 2017 to April 17, 2018, we enrolled 600 patients (median [IQR] age 34 [29-40] and CD4 count 286 [128-490]; 63% female) in South Africa and 477 patients in Kenya (median [IQR] age 35 [29-43] and CD4 count 283 [117-541]; 58% female). In the intervention arm, 78% of patients initiated ≤28 days in South Africa, compared to 68% in the standard arm (risk difference [RD] [95% confidence interval (CI)] 10% [3%-17%]); in Kenya, 94% of intervention-arm patients initiated ≤28 days compared to 89% in the standard arm (6% [0.5%-11%]). By 8 months in South Africa, 161/298 (54%) intervention-arm patients had initiated and were retained, compared to 146/302 (48%) in the standard arm (6% [(2% to 14%]). By 8 months in Kenya, the corresponding retention outcomes were identical in both arms (137/240 [57%] of intervention-arm patients and 136/237 [57%] of standard-arm patients). Limitations of the trial included limited geographic representativeness, exclusion of patients too ill to participate, missing viral load data, greater study fidelity to the algorithm than might be achieved in standard care, and secular changes in standard care over the course of the study. CONCLUSIONS: In South Africa, the SLATE algorithm increased uptake of ART within 28 days by 10% and showed a numerical increase (6%) in retention at 8 months. In Kenya, the algorithm increased uptake of ART within 28 days by 6% but found no difference in retention at 8 months. Eight-month retention was poor in both arms and both countries. These results suggest that a simple structured algorithm for same-day treatment initiation procedures is feasible and can increase and accelerate ART uptake but that early retention on treatment remains problematic. TRIAL REGISTRATION: Clinicaltrials.gov NCT02891135, registered September 1, 2016. First participant enrolled March 6, 2017 in South Africa and July 13, 2017 in Kenya.

Systematic Literature Review and Meta-Analysis of Response to First-Line Therapies for Advanced/Metastatic Urothelial Cancer Patients Who Are Cisplatin Ineligible.

OBJECTIVE: The purpose of this systematic literature review (SLR) and meta-analysis was to compile the response of historic treatment options in first-line settings for patient populations who are cisplatin ineligible. MATERIALS AND METHODS: SLR was conducted to compile objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) of historic therapies for this population based on stringent criteria. Clinical trials published in English from January 1991 to June 2016 were identified by searching the PubMed (Medline), Cochrane, and Embase databases. RESULTS: Eighteen studies (21 arms; N=810) were identified and used for this meta-analysis. For all treatments included in these studies, the pooled ORR was 0.36 (95% confidence interval [CI], 0.30-0.42). The ORR for the carboplatin+gemcitabine arms (6 arms; N=259), which is the National Comprehensive Cancer Network's recommended first-line treatment (before approval of atezolizumab and pembrolizumab) for this population was 0.36 (95% CI, 0.30-0.42), the median DOR (4 arms) was 7.00 months (95% CI, 4.34-11.29), and the median OS was 8.39 months (95% CI, 7.05-9.98). CONCLUSIONS: The results of this SLR clearly demonstrate the paucity of clinical studies that assess therapeutic intervention in truly cisplatin-ineligible advanced/metastatic urothelial carcinoma subjects and highlight the development of novel therapies that can create real improvement in long-term outcomes. The recent approval of 2 checkpoint inhibitors, atezolizumab and pembrolizumab, were added in the National Comprehensive Cancer Network guidance as recommended first-line treatment for cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma and has provided alternatives for this patient population.