Implementing quality management strategies improves clinical quality as a voluntary medical male circumcision program in Namibia matures: a process analysis.

BACKGROUND: Surgical voluntary medical male circumcision (VMMC) is a safe procedure; however, maintaining quality standards at scale, particularly during scale-up, is a challenge making ongoing quality management (QM) efforts essential. This study describes program quality measured by rates of adverse events (AEs) over four years of VMMC implementation in Namibia, compares AE rates over time, and discusses QM processes that contextualize AE trends and illustrate improvements in quality as the program matured. The International Training and Education Center for Health (I-TECH) assisted the Namibian Ministry of Health and Social Services (MoHSS) in expanding VMMC in three regions among boys and men over 10 years of age between January 2015 and September 2019. METHODS: A comprehensive package of QM strategies was implemented by multi-disciplinary onsite teams with support from national and international technical advisors. Retrospective routine MoHSS data from the VMMC register, client forms, and monthly AE reports were collected during implementation in the three regions to assess the impact of QM interventions on AEs and to calculate the proportion of clients who experienced AEs over time. The proportion of clients who experienced an AE over time was compared using a Cochran-Armitage test for trend. RESULTS: Between January 2015 and September 2019, 40,336 clients underwent VMMC and 593 (1.5%) clients experienced a post-operative AE in the three supported regions. The AE rate was highest in the first quarter of clinical service delivery in each region (January-March 2015 in Oshana and Zambezi, October-December 2017 in //Kharas) but declined over the implementation period as the program matured. This observed trend between program maturity and declining AE rates over time was significant (p < 0.001) when compared using a Cochran-Armitage test for trend. CONCLUSIONS: As the I-TECH-supported VMMC program matured, QM measures were introduced and routinized, and clinical quality improved over time with the rate of AEs decreasing significantly over the implementation period. Applying systematic and continuous QM processes and approaches across the continuum of VMMC services and considering local context can contribute to increased clinical safety. QM measures that are established in more mature program sites can be quickly adopted to respond to quality issues in program expansion sites.

A comparison of cardiopulmonary bypass versus extracorporeal membrane oxygenation: Does intraoperative circulatory support strategy affect outcomes in pediatric lung transplantation?

OBJECTIVE: Data on adult lung transplantation suggest perioperative benefits of intraoperative extracorporeal membrane oxygenation (ECMO) compared to cardiopulmonary bypass (CPB). Information regarding their pediatric counterparts, however, is limited. This study compares outcomes of intraoperative ECMO versus CPB in pediatric lung transplantation. METHODS: We reviewed all pediatric lung transplants at our institution from 2014 to 2019 and compared those supported intraoperatively on ECMO (n = 13) versus CPB (n = 22), plus a conditional analysis excluding re-transplantations (ECMO [n = 13] versus CPB [n = 20]). We evaluated survival, surgical times, intraoperative transfusions, postoperative support, complications, and duration of hospitalization. RESULTS: Total time on ECMO support was significantly less than that of CPB support (P = .018). Intraoperatively, the ECMO group required fewer transfusions of fresh-frozen plasma (8.9 [5.8-22.3] vs 16.6 [11.4-39.0] mL/kg, P = .049) and platelets (4.2 [0.0-6.7] vs 8.0 [3.5-14.0] mL/kg, P = .049). When excluding re-transplantations, patients on ECMO required fewer packed red blood cells intraoperatively (12.6 [2.1-30.7] vs 28.2 [14.0-54.0] mL/kg, P = .048). There were no differences in postoperative support requirements, complications, or mortality at one, six, and twelve months. CONCLUSIONS: Intraoperative ECMO support during pediatric lung transplantation appears to decrease intraoperative transfusion requirements when compared to CPB. Data from additional institutions may strengthen these observations.

Development of the Adult ECMO Specialist Certification Examination.

The American Society of Extracorporeal Technology Board of Directors, consistent with the American Society of Extracorporeal Technology's safe patient care improvement mission, charged the International Board of Blood Management to write a knowledge and skill certification examination for healthcare personnel employed as adult extracorporeal membrane oxygenation (ECMO) specialists. Nineteen nationally recognized ECMO subject-matter experts were selected to complete the examination development. A job analysis was performed, yielding a job description and examination plan focused on 16 job categories. Multiple-choice test items were created and validated. Qualified ECMO specialists were identified to complete a pilot examination and both pre- and post-examination surveys. The examination item difficulty and candidate performance were ranked and matched using Rasch methodology. Candidates' examination scores were compared with their profession, training, and experience as ECMO specialists. The 120-item pilot examination form ranked 76 ECMO specialist candidates consistent with their licensure, ECMO training, and clinical experience. Forty-three registered nurses, 28 registered respiratory therapists, four certified clinical perfusionists, and one physician assistant completed the pilot examination process. Rasch statistics revealed examination reliability coefficients of .83 for candidates and .88 for test items. Candidates ranked the appropriateness for examination items consistent with the item content, difficulty, and their personal examination score. The pilot examination pass rate was 80%. The completed examination product scheduled for enrollment in March 2020 includes 100 verified test items with an expected pass rate of 84% at a cut score of 67%. The online certification examination based on a verified job analysis provides an extramural assessment that ranks minimally prepared ECMO specialists' knowledge, skills, and abilities (KSA) consistent with safe ECMO patient care and circuit management. It is anticipated that ECMO facilities and ECMO service providers will incorporate the certification examination as part of their process improvement, safety, and quality assurance plans.

Subsidizing Health Insurance for Low-Income Adults: Evidence from Massachusetts.

How much are low- income individuals willing to pay for health insurance, and what are the implications for insurance markets? Using administrative data from Massachusetts' subsidized insurance exchange, we exploit discontinuities in the subsidy schedule to estimate willingness to pay and costs of insurance among low- income adults. As subsidies decline, insurance take- up falls rapidly, dropping about 25 percent for each $40 increase in monthly enrollee premiums. Marginal enrollees tend to be lower- cost, indicating adverse selection into insurance. But across the entire distribution we can observe (approximately the bottom 70 percent of the willingness to pay distribution) enrollees' willingness to pay is always less than half of their own expected costs that they impose on the insurer. As a result, we estimate that take- up will be highly incomplete even with generous subsidies. If enrollee premiums were 25 percent of insurers' average costs, at most half of potential enrollees would buy insurance; even premiums subsidized to 10 percent of average costs would still leave at least 20 percent uninsured. We briefly consider potential explanations for these findings and their normative implications.

The Evolution of Health Insurer Costs in Massachusetts, 2010-12.

We analyze the evolution of health insurer costs in Massachusetts between 2010-2012, paying particular attention to changes in the composition of enrollees. This was a period in which Health Maintenance Organizations (HMOs) increasingly used physician cost control incentives but Preferred Provider Organizations (PPOs) did not. We show that cost growth and its components cannot be understood without accounting for (i) consumers' switching between plans, and (ii) differences in cost characteristics between new entrants and those leaving the market. New entrants are markedly less costly than those leaving (and their costs fall after their entering year), so cost growth of continuous enrollees in a plan is significantly higher than average per-member cost growth. Relatively high-cost HMO members switch to PPOs while low-cost PPO members switch to HMOs, so the impact of cost control incentives on HMO costs is likely different from their impact on market-wide insurer costs.

Recommendations for utilization of the paracorporeal lung assist device in neonates and young children with pulmonary hypertension.

The management of decompensating critically ill children with severe PH is extremely challenging and requires a multidisciplinary approach. Unfortunately, even with optimal care, these children might continue to deteriorate and develop inadequate systemic perfusion and at times cardiac arrest secondary to a pulmonary hypertensive crisis. Tools to support these children are limited, and at times, the team should proceed with offering extracorporeal support, especially in newly diagnosed patients who have not benefitted from medical therapy prior to their acute deterioration, in patients with severe pulmonary venous disease and in patients with alveolar capillary dysplasia. Currently, the only approved mode for extracorporeal support in pediatric patients with PH eligible for lung transplantation is ECMO. To decrease the risks associated with ECMO, and offer potential for increased duration of support, extubation, and rehabilitation, we transitioned four small children with refractory PH from ECMO to a device comprising an oxygenator interposed between the PA and LA. This work describes in great detail our experience with this mode of support with emphasis on exclusion criteria, the implantation procedure, and the post-implantation management.

Small Marketplace Premiums Pose Financial And Administrative Burdens: Evidence From Massachusetts, 2016-17.

Health insurance premiums are primarily understood to pose financial barriers to coverage. However, the need to remit monthly premium payments may also create administrative burdens that negatively affect coverage, even in cases where affordability is a negligible concern. Using 2016-17 data from the Massachusetts health insurance Marketplace and a natural experiment, we evaluated how coverage retention was affected by the introduction of nominal (less than $10 for most enrollees) monthly premiums for plans that previously had $0 premiums. Compared with plans that maintained $0 premiums, those that took on nominal premiums saw enrollment fall by 14 percent over the following year. This attrition was attributable to terminations for nonpayment; most terminations occurred at the end of January, implying that a significant number of affected enrollees never initiated premium payments. These findings suggest that even very small premiums act as enrollment barriers, which may sometimes reflect administrative burdens more than financial hardship. Several policy approaches could mitigate adverse coverage outcomes related to nominal premiums.

Adverse selection and network design under regulated plan prices: Evidence from Medicaid.

Health plans for the poor increasingly limit access to specialty hospitals. We investigate the role of adverse selection in generating this equilibrium among private plans in Medicaid. Studying a network change, we find that covering a top cancer hospital causes severe adverse selection, increasing demand for a plan by 50% among enrollees with cancer versus no impact for others. Medicaid's fixed insurer payments make offsetting this selection, and the contract distortions it induces, challenging, requiring either infeasibly high payment rates or near-perfect risk adjustment. By contrast, a small explicit bonus for covering the hospital is sufficient to make coverage profitable.

The Two-Margin Problem in Insurance Markets.

Insurance markets often feature consumer sorting along both an extensive margin (whether to buy) and an intensive margin (which plan to buy). We present a new graphical theoretical framework that extends a workhorse model to incorporate both selection margins simultaneously. A key insight from our framework is that policies aimed at addressing one margin of selection often involve an economically meaningful trade-off on the other margin in terms of prices, enrollment, and welfare. Using data from Massachusetts, we illustrate these trade-offs in an empirical sufficient statistics approach that is tightly linked to the graphical framework we develop.

Turnover in Zero-Premium Status Among Health Insurance Marketplace Plans Available to Low-Income Enrollees.

Importance: Recent subsidy enhancements in Affordable Care Act (ACA) Marketplaces made many low-income enrolles (below 150% of the federal poverty level [FPL]) eligible for 2 free silver-tier plans. eligible for 2 free silver-tier plans. However, an unintended consequence of this structure is that the identity of which silver plans are free will often "turn over" between years, requiring that enrollees actively initiate premium payment (or lose coverage). The prevalence of this free-plan turnover is not known. Objective: To measure the prevalence of free-plan turnover in ACA Marketplaces and to estimate how many enrollees below 150% of FPL are likely to be affected. Design Setting and Participants: This observational cross-sectional study used data on plan offerings and premiums in 33 state ACA Marketplaces using HealthCare.gov in 2021 and 2022, along with estimates of county-level enrollee characteristics and plan selection patterns. The enrollment-weighted share of county markets affected by free-plan turnover was quantified, along with the association of turnover with enrollee and market characteristics. Estimates of the number of affected low-income enrollees were calculated using the data plus statistics reported in past research. Data were analyzed from November 21, 2021, to February 28, 2022. Results: This study found that turnover of zero-premium plans was quite common, with 93% of HealthCare.gov counties (weighted by enrollment) experiencing at least 1 zero-premium plan in 2021 turning over to nonfree in 2022; 84% of counties experienced turnover of all $0 silver plans from 2021 to 2022. This turnover affected an estimated 1.36 million people with incomes below 150% of FPL. Turnover was more common in counties with a higher share of non-White enrollees, in Medicaid nonexpansion states, in counties with more carriers, and in counties with changes in the number of offered plans. Conclusions and Relevance: The findings of this cross-sectional study suggest that owing to the prevalence of zero-premium plan turnover, many low-income ACA enrollees faced elevated risk of disenrollment at the start of 2022. Outreach to affected enrollees and other actions to encourage coverage retention and midyear reenrollment could help mitigate coverage losses.

Evolution of Ventricular Assist Device Support Strategy in Children With Univentricular Physiology.

BACKGROUND: Since 2012, we have supported 18 children with single ventricle (SV) physiology on ventricular assist devices (VADs) as a bridge to decision, transplantation, or recovery. We provide a detailed report of our cumulative surgical experience and lessons learned from these patients. METHODS: We reviewed all SV-VADs between March 2012 and April 2020. Implanted SV-VADs intended for short-term support were excluded. Demographic and clinical data included palliation stage at the time of VAD implantation, cannulation configuration, device type, duration of support, circuit and device interventions, postoperative support, anticoagulation strategy, complications, mortality, and 1-year survival postdischarge. RESULTS: Five SV newborns without prior surgical palliation, 8 infants post-Norwood/hybrid procedure, 4 infants post-Glenn, and 1 infant post-Fontan were initially supported with either continuous-flow (n = 13 of 18, 72%) or pulsatile-flow (n = 5 of 18, 28%) devices. Three (17%) of 18 transitioned to another device during support. Before VAD conversion, 9 (50%) of 18 were supported by extracorporeal membrane oxygenation. Outcomes included 7 (39%) of 18 who transplanted, 2 (11%) of 18 who recovered, and 9 (50%) of 18 who died before discharge. Of these deaths, 2 occurred after transplantation and 2 after explantation, and 5 had redirection of care while on support secondary to previously undiagnosed pulmonary venoocclusive disease (n = 2) or severe neurologic events (n = 3). Overall, 6 (33%) of 18 experienced neurologic injury. At last follow-up, 9 (50%) of 18 children were alive (median 1.2 [interquartile range, 0.8-4.3] years postexplantation/transplantation). CONCLUSIONS: Our experience shows that SV children, including newborns, can be successfully bridged to desired endpoints with proper patient selection and using specific cannulation strategies. Continuing utilization of this strategy is warranted for future children requiring VAD support.

Adverse event profile and associated factors following surgical voluntary medical male circumcision in two regions of Namibia, 2015-2018.

INTRODUCTION: Monitoring clinical safety of voluntary medical male circumcision (VMMC) is critical to minimize risk as VMMC programs for HIV prevention are scaled. This cross-sectional analysis describes the adverse event (AE) profile of a large-scale, routine VMMC program and identifies factors associated with the development, severity, and timing of AEs to provide recommendations for program quality improvement. MATERIALS AND METHODS: From 2015-2018 there were 28,990 circumcisions performed in International Training and Education Center for Health (I-TECH) supported regions of Namibia in collaboration with the Ministry of Health and Social Services. Two routine follow-up visits after VMMC were scheduled to identify clients with AEs. Summary statistics were used to describe characteristics of all VMMC clients and the subset who experienced an AE. We used chi-square tests to evaluate associations between AE timing, patient age, and other patient and AE characteristics. We used a logistic regression model to explore associations between patient characteristics and AE severity. RESULTS: Of the 498 clients with AEs (AE rate of 1.7%), 40 (8%) occurred ≤2 days, 262 (53%) occurred 3-7 days, 161 (32%) between day 8 and 14, and 35 (7%) were ≥15 days post-VMMC. Early AEs (on or before day 2) tended to be severe and categorized as bleeding, while infections were the most common AEs occurring later (p<0.001). Younger clients (aged 10-14 years) experienced more infections, whereas older clients experienced more bleeding (p<0.001). CONCLUSIONS: Almost 40% of AEs occurred after the second follow-up visit, of which 179 (91%) were infections. Improvements in pre-surgical and post-surgical counselling and post-operative educational materials encouraging clients to seek care at any time, adoption of alternative follow-up methods, and the addition of a third follow-up visit may improve outcomes for patients. Enhancing post-surgical counselling and emphasizing wound care for younger VMMC clients and their caregivers could help mitigate elevated risk of infection.

Context-Responsive Anticoagulation Reduces Complications in Pediatric Extracorporeal Membrane Oxygenation.

Purpose: We sought to determine the impact of a comprehensive, context-responsive anticoagulation and transfusion guideline on bleeding and thrombotic complication rates and blood product utilization during extracorporeal membrane oxygenation (ECMO). Design: Single-center, observational pre- and post-implementation cohort study. Setting: Academic pediatric hospital. Patients: Patients in the PICU, CICU, and NICU receiving ECMO support. Interventions: Program-wide implementation of a context-responsive anticoagulation and transfusion guideline. Measurements: Pre-implementation subjects consisted of all patients receiving ECMO between January 1 and December 31, 2012, and underwent retrospective chart review. Post-implementation subjects consisted of all ECMO patients between September 1, 2013, and December 31, 2014, and underwent prospective data collection. Data collection included standard demographic and admission data, ECMO technical specifications, non-ECMO therapies, coagulation parameters, and blood product administration. A novel grading scale was used to define hemorrhagic complications (major, intermediate, and minor) and major thromboembolic complications. Main Results: Seventy-six ECMO patients were identified: 31 during the pre-implementation period and 45 in the post-implementation period. The overall observed mortality was 33% with no difference between groups. Compared to pre-implementation, the post-implementation group experienced fewer major hemorrhagic and major thrombotic complications and less severe hemorrhagic complications and received less RBC transfusion volume per kg. Conclusions: Use of a context-responsive anticoagulation and transfusion guideline was associated with a reduction in hemorrhagic and thrombotic complications and reduced RBC transfusion requirements. Further evaluation of guideline content, compliance, performance, and sustainability is needed.

Building workforce capacity for effective use of health information systems: Evaluation of a blended eLearning course in Namibia and Tanzania.

BACKGROUND: Electronic health information systems (HIS) are critical components of national health systems, and have been identified as a key element in the development and strengthening of health systems globally. Novel approaches are needed to effectively and efficiently train health care workers on the use of HIS. One such approach is the use of digital eLearning programs, either alone or blended with face-to-face learning activities. METHODS: We developed a novel blended eLearning course based on an in-person HIS training package previously developed by the United States Centers for Disease Control and Prevention. We then conducted a pilot implementation of the eLearning course in Namibia and Tanzania. RESULTS: The blended eLearning pilot program enrolled 131 people, 72 (55%) from Namibia and 59 (45%) from Tanzania. The majority of enrollees were female (n = 88, 67%) and were nurses (n = 66, 50%). Of the 131 people who participated in the in-person orientation, 95 (73%) completed some or all of the eLearning modules. Across all three modules, the mean score on the post-test was significantly greater than on the pre-test (p < 0.001). When comparing results from previous in-person workshops and the blended eLearning course, we found that participants experienced strong learning gains in both, although learning gains were somewhat greater in the in-person course. Blended eLearning course participants reported good to very good satisfaction with the overall content of the course and with the eLearning modules (3.5 and 3.6 out of 5-point Likert scale). We estimate that the total cost per participant is 2.2-3.4 times greater for the in-person course (estimated cost USD $980) than for the blended eLearning course (estimated cost USD $287-$437). CONCLUSION: A blended eLearning course is an effective method with which to train healthcare workers in the basic features of HIS, and the cost is up to 3.4 times less expensive than for an in-person course with similar content.

A Different Framework to Achieve Universal Coverage in the US.

This JAMA Forum discusses alternative ways to achieve universal coverage in the US such as administrative simplification in the Affordable Care Act plans to increase enrollment, having a basic policy that would be available to everyone, and options for supplemental coverage.

Why Did Employer Coverage Fall In Massachusetts After The ACA? Potential Consequences Of A Changing Employer Mandate.

The Affordable Care Act (ACA) attempted to minimize disruptions to employer-sponsored insurance in part by implementing an employer mandate. Research has shown that employer coverage rates have been stable nationally under the ACA. Massachusetts enacted its own employer mandate in 2006 before eliminating it in 2014, in anticipation of the federal mandate. But the ACA's employer mandate was delayed until 2015 and exempted smaller firms that had been covered by the Massachusetts' mandate. In this unique policy environment, we found that the employer-sponsored insurance rate in Massachusetts fell by 2.3 percentage points after the ACA's coverage expansion took effect (2014-16), compared to the rest of the US. Coverage dropped more for middle-income workers than for lower-income workers, which suggests that crowd-out by Medicaid was not the primary factor. Employer surveys show that employer coverage offer rates declined significantly at small firms in Massachusetts beginning in 2014, but not at large firms. Our findings suggest that eliminating Massachusetts's employer mandate may have contributed to falling employer coverage rates in the state, although other policy and economic factors cannot be ruled out. These results may have implications for understanding the effects of the ACA's employer mandate and its potential repeal.

A Novel Surgical Approach to Mechanical Circulatory Support in Univentricular Infants.

BACKGROUND: Historically, the options for mechanical circulatory support in infants, particularly those with single-ventricle physiology, have been limited and outcomes have generally been poor. We report a new approach implemented for long-term support in a series of such patients. METHODS: This study is a single-center case series of 7 patients with single-ventricle physiology after stage 1 palliation supported with mechanical circulatory support using a novel technique, between May 2014 and September 2015. Our technique included modification and implantation of commercially available pediatric cannulae into the common atrium and the ascending aorta or reconstructed neoaorta and utilization of a centrifugal extracorporeal pump. RESULTS: Median circulatory support duration was 64 days (range, 35 to 99). One adverse neurologic event was observed in 1 patient, and bleeding requiring reoperation in 2 patients. Support to recovery, decision, or heart transplantation was accomplished in all cases. Of all patients, 43% were successfully discharged home. CONCLUSIONS: Our experience shows that long-term extracorporeal mechanical circulatory support of patients with underlying single-ventricle physiology after stage 1 palliation is feasible utilizing our technique. This approach overcomes several major challenges encountered in these patients, such as high flow requirement and stability of the cannulae, and allows extubation, rehabilitation, and at times, myocardial recovery.

Pediatric HIV Disclosure Intervention Improves Knowledge and Clinical Outcomes in HIV-Infected Children in Namibia.

OBJECTIVES: Using routinely collected data, we evaluated a nationally implemented intervention to assist health care workers and caregivers with HIV disclosure to children. We assessed the impact of the intervention on child's knowledge and health outcomes. METHODS: Data were abstracted from national databases and patient charts for HIV-infected children aged 7-15 years attending 4 high-volume HIV clinics in Namibia. Disclosure rates, time to disclosure, and HIV knowledge in 314 children participating in the intervention were analyzed. Logistic regression was used to identify correlates of partial vs. full disclosure. Paired t-tests and McNemar tests were used to compare adherence and viral load (VL) before versus after intervention enrollment. RESULTS: Among children who participated in the disclosure intervention, 11% knew their HIV status at enrollment and an additional 38% reached full disclosure after enrollment. The average time to full disclosure was 2.5 years (interquartile range: 1.2-3 years). Children who achieved full disclosure were more likely to be older, have lower VLs, and have been enrolled in the intervention longer. Among children who reported incorrect knowledge regarding why they take their medicine, 83% showed improved knowledge after the intervention, defined as knowledge of HIV status or adopting intervention-specific language. On comparing 0-12 months before vs. 12-24 months after enrollment in the intervention, VL decreased by 0.5 log10 copies per milliliter (N = 42, P = 0.004), whereas mean adherence scores increased by 10% (N = 88, P value < 0.001). CONCLUSIONS: This HIV disclosure intervention demonstrated improved viral suppression, adherence, and HIV knowledge and should be considered for translation to other settings.

ECMO for Pediatric Lung Transplantation.

Extracorporeal membrane oxygenation (ECMO) has been reported as an alternative to cardiopulmonary bypass during lung transplantation. The reports in the literature have been limited to adult practice and associated with decreased pulmonary and renal complications, lower mortality, and lower in-hospital mortality. We present four pediatric lung transplantations performed on ECMO and discuss relevant perfusion management.