OpenCell: A low-cost, open-source, 3-in-1 device for DNA extraction.

High-cost DNA extraction procedures pose significant challenges for budget-constrained laboratories. To address this, we introduce OpenCell, an economical, open-source, 3-in-1 laboratory device that combines the functionalities of a bead homogenizer, a microcentrifuge, and a vortex mixer. OpenCell utilizes modular attachments that magnetically connect to a central rotating brushless motor. This motor couples to an epicyclic gearing mechanism, enabling efficient bead homogenization, vortex mixing, and centrifugation within one compact unit. OpenCell's design incorporates multiple redundant safety features, ensuring both the device's and operator's safety. Additional features such as RPM measurement, programmable timers, battery operation, and optional speed control make OpenCell a reliable and reproducible laboratory instrument. In our study, OpenCell successfully isolated DNA from Spinacia oleracea (spinach), with an average yield of 2.3 µg and an A260/A280 ratio of 1.77, demonstrating its effectiveness for downstream applications such as Polymerase Chain Reaction (PCR) amplification. With its compact size (20 cm x 28 cm x 6.7 cm) and lightweight design (0.8 kg), comparable to the size and weight of a laptop, OpenCell is portable, making it an attractive component of a 'lab-in-a-backpack' for resource-constrained environments in low-and-middle-income countries and synthetic biology in remote field stations. Leveraging the accessibility of 3D printing and off-the-shelf components, OpenCell can be manufactured and assembled at a low unit cost of less than $50, providing an affordable alternative to expensive laboratory equipment costing over $4000. OpenCell aims to overcome the barriers to entry in synthetic biology research and contribute to the growing collection of frugal and open hardware.

Virtual Reality and Surgical Simulation Training for Orthopaedic Surgery Residents: A Qualitative Assessment of Trainee Perspectives.

Background: The demonstrated benefits of virtual reality (VR) in orthopaedic surgical training are numerous. However, it is relatively unknown how best to implement VR into an already established orthopaedic resident education curriculum and how trainees will engage and use these technologies longitudinally. Methods: This was an exploratory, qualitative research study performed in accordance with Consolidated Criteria for Reporting Qualitative Research guidelines. Orthopaedic surgery residents at a single institution were recruited during the 2022 to 2023 academic year. Semistructured interviews were conducted. Data were analyzed through grounded theory methodology, beginning with open coding, followed by axial coding, and concluding with selective coding that describes orthopaedic surgery residents' current perceptions of VR as a training tool. Results: Six residents participated in interviews before thematic saturation was achieved. Average interview length was 13:27 (±2:59) minutes. Residents felt that currently, VR is most useful for interns and junior residents as an educational adjunct for learning anatomy, surgical exposures, and the steps of a procedure in a risk- and judgment-free arena. There seems to be a "ceiling effect" with VR given current technological limitations, and residents remarked that there is an associated "opportunity cost" with using VR technology. Some residents may find it more time-efficient to study texts, videos, or surgical guides rather than use VR. Cost (limited number of headsets) and technological barriers (i.e., hardware, software, and Wi-Fi issues) were some of the described barriers to VR utilization. Residents felt that there needs to be dedicated technological support to help with these issues. At this time, given these limitations of VR, many preferred VR as an optional educational adjunct rather than as a required curricular tool or assessment of surgical competency. Conclusions: There is current utility for VR in orthopaedic surgical training. Future technological advances may make VR more central to resident education. This study describes resident perceptions about the technology and best use practices for the technology. Level of Evidence: Qualitative Study, Level V Evidence.

OpenCell: A Low-cost, Open-Source, 3-in-1 device for DNA Extraction.

High-cost DNA extraction procedures pose significant challenges for budget-constrained laboratories. To address this, we introduce OpenCell, an economical, open-source, 3-in-1 laboratory device that combines the functionalities of a bead homogenizer, a microcentrifuge, and a vortex mixer. OpenCell utilizes modular attachments that magnetically connect to a central rotating brushless motor. This motor couples to an epicyclic gearing mechanism, enabling efficient bead homogenization, vortex mixing, and centrifugation within one compact unit. OpenCell's design incorporates multiple redundant safety features, ensuring both the device's and operator's safety. Additional features such as RPM measurement, programmable timers, battery operation, and optional speed control make OpenCell a reliable and reproducible laboratory instrument. In our study, OpenCell successfully isolated DNA from Spinacia oleracea (spinach), with an average yield of 2.3 µg and an A260/A280 ratio of 1.77, demonstrating its effectiveness for downstream applications such as Polymerase Chain Reaction (PCR) amplification. With its compact size (20 cm x 28 cm x 6.7 cm) and lightweight design (0.8 kg), comparable to the size and weight of a laptop, OpenCell is portable, making it an attractive component of a 'lab-in-a-backpack' for resource-constrained environments in low-and-middle-income countries and synthetic biology in remote field stations. Leveraging the accessibility of 3D printing and off-the-shelf components, OpenCell can be manufactured and assembled at a low unit cost of less than $50, providing an affordable alternative to expensive laboratory equipment costing over $4000. OpenCell aims to overcome the barriers to entry in synthetic biology research and contribute to the growing collection of frugal and open hardware.

Family Caregivers of Children With Medical Complexity: Changes in Health-Related Quality of Life and Experiences of Care Coordination.

OBJECTIVE: Examine the longitudinal association between family experiences of care coordination (FECC) and health-related quality of life (HR-QOL) for family caregivers of children with medical complexity (CMC). METHODS: A Longitudinal survey of family caregivers of CMC was completed between July 2018 and June 2020. Baseline data were collected at initial contact with a regional complex care center; follow-up data were collected 12 to 16 months later. Assessed receipt of care coordination and caregiver HR-QOL via FECC questionnaire and Center for Disease Control's HR-QOL-14 measure, respectively. Baseline and follow-up results were compared via McNemar's and Wilcoxon signed-rank tests. Relationships between changes in FECC and changes in HR-QOL were examined using multivariable logistic regression. RESULTS: Of 185 eligible, 136 caregivers enrolled and completed baseline surveys (74%) and 103 (76% initial sample) follow-up surveys. Caregivers reported significant improvements in 8 of 9 FECC measures after 1 year of care within a complex care center (all P < .05). In contrast, caregiver HR-QOL (general health status, unhealthy days, symptom days) remained stable over the study period (all P > .05) except for monthly days of poor sleep (baseline vs follow-up median; 16 vs 15 [P = .05]). At both timepoints, >20% participants rated their general health status as fair-to-poor, and >50% reported frequent poor sleep and fatigue. No significant associations were observed between changes in FECC and changes in HR-QOL. CONCLUSIONS: After receiving 1 year of care through a complex care center, CMC family caregivers report improvement in care coordination but not in HR-QOL. Caregivers' continued mentally unhealthy days and negative mental symptom days highlight the need for a directed intervention.

Financial Toxicity and Out-of-Pocket Costs for Patients with Head and Neck Cancer.

AIM: To quantify financial toxicity and out-of-pocket costs for patients with HNC in Australia and explore their relationship with health-related quality of life (HRQoL). METHODS: A cross-sectional survey was administered to patients with HNC 1-3 years after radiotherapy at a regional hospital in Australia. The survey included questions on sociodemographics, out-of-pocket expenses, HRQoL, and the Financial Index of Toxicity (FIT) tool. The relationship between high financial toxicity scores (top quartile) and HRQoL was explored. RESULTS: Of the 57 participants included in the study, 41 (72%) reported out-of-pocket expenses at a median of AUD 1796 (IQR AUD 2700) and a maximum of AUD 25,050. The median FIT score was 13.9 (IQR 19.5) and patients with high financial toxicity (n = 14) reported poorer HRQoL (76.5 vs. 114.5, p < 0.001). Patients who were not married had higher FIT scores (23.1 vs. 11.1, p = 0.01), as did those with lower education (19.3 vs. 11.1, p = 0.06). Participants with private health insurance had lower financial toxicity scores (8.3 vs. 17.6, p = 0.01). Medications (41%, median AUD 400), dietary supplements (41%, median AUD 600), travel (36%, median AUD 525), and dental (29%, AUD 388) were the most common out-of-pocket expenses. Participants living in rural locations (≥100 km from the hospital) had higher out-of-pocket expenses (AUD 2655 vs. AUD 730, p = 0.01). CONCLUSION: Financial toxicity is associated with poorer HRQoL for many patients with HNC following treatment. Further research is needed to investigate interventions aimed at reducing financial toxicity and how these can best be incorporated into routine clinical care.

A National Profile of Families and Caregivers of Children With Disabilities and/or Medical Complexity.

OBJECTIVE: Provide an up-to-date description of the well-being of families and caregivers of children with disability and medical complexity at the national level. METHODS: We performed a secondary analysis of the 2016-2019 National Survey of Children's Health and divided the sample based on a child's disability and medical complexity status: children with no special health care needs (non-CSHCN), children with special health care needs (CSHCN), CSHCN with significant disabilities (CSHCN-SD), and children with medical complexity (CMC). Outcomes included survey items assessing 1) caregiver emotional well-being, 2) family functioning, and 3) economic adversity. We conducted multivariable logistic regression analyses to examine associations between child disability and medical complexity status with study outcomes. RESULTS: Among 131,774 survey responses, CSHCN-SD (weighted n = 4.2 million) and CMC (n =1.1 million) disproportionately reported adverse outcomes for every measure of well-being. Notably, caregivers of CSHCN-SD and CMC were more likely to report frequently feeling bothered (aOR 5.0 and 6.3, respectively) and angry (aOR 3.0 and 3.1) with their child than non-CSHCN caregivers. Families of CSHCN-SD and CMC had 40% lower odds of endorsing all aspects of family resilience and more likely to report three or more adverse childhood experiences (aOR 3.3 and 3.7) than non-CSHCN families. CSHCN-SD and CMC families were also more likely to experience difficulty covering basics (aOR, 2.6 and 3.3) and report caregivers changing jobs due to their child's care (aOR, 3.1 and 5.0). CONCLUSIONS: Development and testing of interventions specifically targeting the well-being of CSHCN-SD and CMC families and caregivers is needed.

The Mental and Physical Health of Mothers of Children with Special Health Care Needs in the United States.

OBJECTIVE: To determine the prevalence of poor mental and physical health among mothers of children with special health care needs (CSHCN) and to determine the association between maternal health and the child's number of special health care needs (SHCN) and severity of ability limitation. METHODS: We used the combined 2016-2018 National Survey of Children's Health Dataset of 102,341 children ages 0-17 including 23,280 CSHCN. We used regression models to examine the associations of a child's number of SHCN and ability limitations with maternal health. RESULTS: Twice as many mothers of CSHCN had poor mental and physical health compared to non-CSHCN (mental 10.3% vs. 4.0%, p < .001; physical 11.9% vs 5.0%, p < .001). In regression models, increased number of SHCN and severity of activity limitations were associated with significantly increased odds of poor maternal health. CONCLUSIONS FOR PRACTICE: Mothers of CSHCN have worse health compared to mothers of non-CSHCN, especially those who experience social disadvantage and those with children with complex SHCN or severe ability limitations. Interventions to improve the health of these particularly vulnerable caregivers of CSHCN are warranted.

Underinsurance Among Children in the United States.

OBJECTIVES: We describe the change in the percentage of children lacking continuous and adequate health insurance (underinsurance) from 2016 to 2019. We also examine the relationships between child health complexity and insurance type with underinsurance. METHODS: Secondary analysis of US children in the National Survey of Children's Health combined 2016-2019 dataset who had continuous and adequate health insurance. We calculated differences in point estimates, with 95% confidence intervals (CIs), to describe changes in our outcomes over the study period. We used multivariable logistic regression adjusted for sociodemographic characteristics and examined relationships between child health complexity and insurance type with underinsurance. RESULTS: From 2016 to 2019, the proportion of US children experiencing underinsurance rose from 30.6% to 34.0% (+3.4%; 95% CI, +1.9% to +4.9%), an additional 2.4 million children. This trend was driven by rising insurance inadequacy (24.8% to 27.9% [+3.1%; 95% CI, +1.7% to +4.5%]), which was mainly experienced as unreasonable out-of-pocket medical expenses. Although the estimate of children lacking continuous insurance coverage rose from 8.1% to 8.7% (+0.6%), it was not significant at the 95% CI (-0.5% to +1.7%). We observed significant growth in underinsurance among White and multiracial children, children living in households with income ≥200% of the federal poverty limit, and those with private health insurance. Increased child health complexity and private insurance were significantly associated with experiencing underinsurance (adjusted odds ratio, 1.9 and 3.5, respectively). CONCLUSIONS: Underinsurance is increasing among US children because of rising inadequacy. Reforms to the child health insurance system are necessary to curb this problem.

Brolucizumab vs aflibercept and ranibizumab for neovascular age-related macular degeneration: a cost-effectiveness analysis.

BACKGROUND: Age-related macular degeneration (AMD) is a leading cause of blindness worldwide and is the most common cause of blindness in developed countries. Despite antivascular endothelial growth factor (anti-VEGF) therapy demonstrating improvements in visual and anatomical outcomes, unmet needs remain. Brolucizumab-dbll (ie, brolucizumab), a VEGF inhibitor for treatment of neovascular (wet) AMD and recently approved by the FDA for its treatment of wet AMD, attempts to mitigate treatment burden through less frequent injections. OBJECTIVE: To assess the incremental cost-effectiveness of brolucizumab compared with aflibercept and ranibizumab, given similar costs per injection and the potential for longer dosing intervals based on phase 3 clinical trial data. METHODS: A Markov model was developed to model the treatment of wet AMD patients with brolucizumab vs aflibercept and vs ranibizumab over a lifetime time horizon (base case) and 5-year time horizon (scenario analysis). The Markov model consisted of 3 primary health states: on treatment, off treatment, and death. Markov substates (5 total) described visual acuity (VA) ranging from no vision impairment to blindness. These VA-based substates were defined by best-corrected visual acuity (BCVA) values measured using Early Treatment Diabetic Retinopathy Study letters. Fixed-dosing regimens for each therapy were included in the model: dosing every 4 weeks (q4w) for the first 3 months followed by dosing q8w/q12w for brolucizumab, dosing q4w for the first 3 months followed by dosing q8w for aflibercept, and q4w for ranibizumab. RESULTS: In the base case, brolucizumab was less costly than aflibercept ($63,614 vs $72,189), and brolucizumab generated 0.0079 more quality-adjusted life-years (QALYs) than aflibercept (4.580 vs 4.572). Lower total costs with brolucizumab were driven by reduced drug costs ($56,432 vs $64,057), reduced administration costs ($6,013 vs $6,825), and reduced monitoring costs ($1,168 vs $1,306). When evaluating the cost-effectiveness of brolucizumab over a 5-year time horizon, brolucizumab was less costly than aflibercept ($44,644 vs $50,772) and generated an additional 0.0049 QALYs (2.953 vs 2.948). Additionally, brolucizumab was less costly than ranibizumab ($63,614 vs $128,163) and generated 0.0078 more QALYs than ranibizumab (4.580 vs 4.572) in the base case. Lower total costs with brolucizumab were driven by reduced drug costs ($56,432 vs $114,516), reduced administration costs ($6,013 vs $11,541), and reduced monitoring costs ($1,168 vs $2,107). When evaluating the cost-effectiveness of brolucizumab over a 5-year time horizon, brolucizumab was less costly than ranibizumab ($44,644 vs $89,665), and brolucizumab generated an additional 0.0046 QALYs (2.953 vs 2.948). CONCLUSIONS: Brolucizumab can be cost saving and cost-effective compared with aflibercept and ranibizumab in the treatment of wet AMD. DISCLOSURES: Novartis Pharmaceuticals Corporation provided funding to Xcenda for the cost-effectiveness analysis and preparation of this manuscript. Carlton is an employee of Xcenda. Agashivala is employed by Novartis Pharmaceuticals Corporation; Yu was an employee of Novartis Pharmaceutical Corporation at the time of this study. Hassan reports personal fees from iOPEN, BVI/Visitrec, ArcticDx, Bayer, F. Hoffmann-La Roche Ltd, Broadspot, BMC, Katalyst Surgical, Alcon, Vitreq, Surgicube, personal Ocugenix, Regeneron, Allergan, Oculus Surgical, Novartis, Genentech, and Eyepoint, unrelated to this work. Wykoff reports personal fees from Corcept Therapeutics, DORC, EyePoint, Gyroscope, IVERIC Bio, Merck, Notal Vision, ONL Therapeutics, Oxurion, Palatin, PolyPhotonix, Takeda, Thea Open Innovation; grants from Aerie Pharmaceuticals, Aldeyra, Gemini Therapeutics, Graybug Vision, IONIS Pharmaceutical, LMRI, Mylan, Neurotech Pharmaceuticals, Outlook Pharmaceuticals, Samsung Bioepis, Senju, Taiwan Liposome Company, Xbrane BioPharma, Santen; and grants and personal fees from Adverum, Allergan, Apellis, Chengdu Kanghong Biotechnologies (KHB), Clearside Biomedical, Genentech, Kodiak Sciences, NGM Biopharmaceuticals, Novartis, Opthea, Recens Medical, Regenxbio, Roche, and Regeneron, unrelated to this work. This research was presented as a virtual poster at the AMCP 2020 Annual Meeting, April 2020.

Family Caregivers of Children With Medical Complexity: Health-Related Quality of Life and Experiences of Care Coordination.

OBJECTIVE: To examine the association between care coordination experiences of family caregivers of children with medical complexity (CMC) and caregivers' health-related quality of life (HR-QOL). METHODS: From July 2018 to July 2019, family caregivers of CMC completed an electronic survey (n = 136) at the time of initial contact with a regional complex care medical home. Information on caregiver HR-QOL and receipt of care coordination services were assessed using the Center for Disease Control's HR-QOL-14 measure and Family Experiences of Care Coordination questionnaire, respectively. Negative binomial regression, adjusted for caregiver and child characteristics, examined associations between caregiver HR-QOL and caregiver experiences of care coordination. RESULTS: In the 30 days prior to initial contact, CMC caregivers reported a median of 3.5 mentally unhealthy days, 2 days felt depressed, 7 days felt anxious, and 16 days with insufficient sleep. Caregivers who had a knowledgeable, supportive care coordinator who advocates for their child reported significantly fewer days mentally unhealthy (incidence rate ratio [IRR], 0.46; 95% confidence interval [CI], 0.22-0.95), depressed (IRR, 0.44; 95% CI, 0.21-0.91), or anxious (IRR, 0.5; 95% CI, 0.29-0.85). Having a shared care plan was associated with significantly fewer days mentally unhealthy (IRR, 0.46; 95% CI, 0.23-0.93) or anxious (IRR, 0.53; 95% CI, 0.31-0.92). Having a written visit summary with appropriate content was associated with fewer days of insufficient sleep (IRR, 0.63; 95% CI, 0.43-0.93). CONCLUSIONS: CMC family caregivers report experiencing mentally unhealthy days and negative mental symptom days. The experience of specific care coordination activities was associated with higher caregiver mental HR-QOL.

Juvenile Nasopharyngeal Angiofibroma Outcomes and Cost: Analysis of the Kids' Inpatient Database.

OBJECTIVE: To report trends in Juvenile Nasopharyngeal Angiofibroma (JNA) hospitalizations and identify key factors affecting treatment outcomes and cost of care in JNA patients. METHODS: The Healthcare Cost and Utilization Project (HCUP) Kids' Inpatient Database was queried for all cases of JNA between the years of 1997 and 2016. Key factors extracted were patient demographics, geographic region, hospital size, teaching status, elective admissions, and number of diagnoses and procedures performed during the hospitalization. These elements were correlated to length of stay (LOS) and cost-per-day (CPD) using a multiple linear regression (MLR). Regional variation in JNA diagnosis and changes in LOS and CPD trends over time were also analyzed. RESULTS: A total of 614 JNA patients were hospitalized in this time period, with a majority of patients identifying as male (98%) and Caucasian/White (55%). The average LOS has decreased by 0.14 day per year since 1997 (P = .0034) whereas the CPD has steadily increased by $2 380 per year (P < .001). MLR analysis revealed that while holding all other factors constant, patients who stayed at teaching hospitals had an increased LOS of 1.7 days (P = .026), but paid $11 961 less per day (P = .05). Regional variation in CPD was found in the Northeast region, where hospitalizations were more expensive by $9 801 per day compared to the South (P = .017). CONCLUSION: These results indicate hospital characteristics, such as teaching status and geographic region, may predict differences in JNA outcomes and cost. Healthcare providers should be cognizant of these variations to ensure optimal patient outcomes and expenditures.

Development of a claims-based algorithm to identify potentially undiagnosed chronic migraine patients.

OBJECTIVE: To develop a claims-based algorithm to identify undiagnosed chronic migraine among patients enrolled in a healthcare system. METHODS: An observational study using claims and patient survey data was conducted in a large medical group. Eligible patients had an International Classification of Diseases, Ninth/Tenth Revision (ICD-9/10) migraine diagnosis, without a chronic migraine diagnosis, in the 12 months before screening and did not have a migraine-related onabotulinumtoxinA claim in the 12 months before enrollment. Trained clinicians administered a semi-structured diagnostic interview, which served as the gold standard to diagnose chronic migraine, to enrolled patients. Potential claims-based predictors of chronic migraine that differentiated semi-structured diagnostic interview-positive (chronic migraine) and semi-structured diagnostic interview-negative (non-chronic migraine) patients were identified in bivariate analyses for inclusion in a logistic regression model. RESULTS: The final sample included 108 patients (chronic migraine = 64; non-chronic migraine = 44). Four significant predictors for chronic migraine were identified using claims in the 12 months before enrollment: ≥15 versus <15 claims for acute treatment of migraine, including opioids (odds ratio = 5.87 [95% confidence interval: 1.34-25.63]); ≥24 versus <24 healthcare visits (odds ratio = 2.80 [confidence interval: 1.08-7.25]); female versus male sex (odds ratio = 9.17 [confidence interval: 1.26-66.50); claims for ≥2 versus 0 unique migraine preventive classes (odds ratio = 4.39 [confidence interval: 1.19-16.22]). Model sensitivity was 78.1%; specificity was 72.7%. CONCLUSIONS: The claims-based algorithm identified undiagnosed chronic migraine with sufficient sensitivity and specificity to have potential utility as a chronic migraine case-finding tool using health claims data. Research to further validate the algorithm is recommended.

Surgical Quality Improvement: Working Toward Value or a Work in Progress?

BACKGROUND: Despite numerous national programs intended to ensure patients receive high-quality surgical care, contemporaneous quality improvement initiatives (QIIs) are limited by the challenges associated with developing universal consensus about how best to define "quality" and the identification of appropriate and actionable quality measures. MATERIALS AND METHODS: Using the Donabedian conceptual model for the evaluation of health care quality, representative examples of existing surgical QIIs at each level of health care (i.e., structure, process, and outcome) were identified, and the effectiveness of these programs was discussed. RESULTS: Surgical volume-based measures are a common structural quality indicator. It remains unclear whether volume-based QIIs, such as "Take the Volume Pledge" and the Leapfrog Group's Evidence-Based Hospital Referral initiative, would improve surgical outcomes or potentially exacerbate existing health care disparities. QIIs focused on processes of care, such as the Surgical Care Improvement Project, are frequently effective at improving measure compliance without clearly improving care quality. Risk-adjusted outcome measures remain common quality indicators. But, relevant procedure-specific outcomes are lacking, and continuing to rely on perioperative morbidity and mortality may not provide the most robust picture of surgical quality. CONCLUSIONS: Data regarding the effectiveness of existing QIIs suggest there may be important opportunities to either select measures that more accurately reflect quality surgical care or enhance the manner in which current quality indicators are measured and reported to better capture the complex dynamics of surgical services at the point of care.

Evaluation of hospitalization costs and associated factors among maternity stays involving low-risk and moderate- to high-risk childbirths in the United States.

OBJECTIVES: This study aimed to assess the costs of childbirth and to identify factors associated with such hospital costs for low- and moderate/high-risk childbirth groups. METHODS: All hospitalizations for childbirth between 2010-2014 in the Premier Perspective Hospital Database were identified. Risk category for each birth was defined by the age of the subject and/or presence of specific maternal comorbidities and obstetric risk factors. Hospital childbirth costs were determined and stratified by risk groups. Factors associated with costs for each risk group were evaluated by multiple regression. RESULTS: Among 2,367,195 hospitalizations for childbirth, vaginal birth was the most common delivery method (n = 1,596,757; 68%). Among women characterized as moderate/high-risk, 42% (n = 642,495) had C-sections, while 11% (n = 90,211) of women categorized as low-risk had C-sections. The proportion of women with serious maternal morbidity among moderate/high-risk vs. low-risk women was 2% (n = 29,496) vs. 0.3% (n = 2749), respectively. The mean costs for moderate/high-risk vs. low-risk hospitalizations were $6145 (median = $5760) and $5397 (median = $5001), respectively (p < 0.0001). Factors significantly associated with costs for moderate/high-risk hospitalizations included delivery type (C-section vs. vaginal birth), LOS, urban/rural hospital status, geographic regions, calendar year of hospitalization, teaching status, payer types and serious maternal morbidity. Similar factors were found to impact costs among low-risk hospitalizations. CONCLUSIONS: Characteristics such as delivery type, LOS, geographical region, teaching status, serious maternal morbidity and hospital urban/rural status were shown to impact hospital costs of childbirth. Screening and prevention strategies of factors that negatively impact costs may aid in reducing the hospitalization costs associated with childbirths.

Performance-Based Risk-Sharing Arrangements for Pharmaceutical Products in the United States: A Systematic Review.

BACKGROUND: Value for money is a growing necessity in today's U.S. health care system in which drug spending is expected to increase by an average rate of 6.7% yearly through 2025. In response to uncertainty about real-world clinical and economic outcomes for many drugs, health insurers and pharmacy benefit managers (PBMs) have implemented various contracts and arrangements with drug manufacturers that can collectively be described as performance-based risk-sharing arrangements (PBRSAs). Little is known about U.S.-specific PBRSAs for drugs. OBJECTIVES: To conduct a systematic review of U.S.-specific PBRSAs for drugs to describe (a) trends over time and (b) key aspects including outcome measures and terms of arrangements between stakeholders. METHODS: A systematic review was conducted in MEDLINE (January 1, 1946-April 1, 2017), Embase (January 1, 1988-April 1, 2017), and the grey literature (up to April 1, 2017) to identify publicly disclosed PBRSAs. Articles and conference abstracts were included if they were published in English and described a U.S.-specific PBRSA for a drug. Articles and conference abstracts were excluded if they only described a PBRSA similar to a money-back guarantee to patients. They were also excluded if they only described a PBRSA between a PBM and a health insurer in which the latter would receive a discount for patients nonadherent to a drug. Results were summarized as counts and percentages. RESULTS: From the literature review, 26 publicly disclosed PBRSAs were identified. Of these, 16 (62%) were announced or initiated from 2015 to 2017, and 10 (38%) were announced or initiated from 1997 to 2012. Thirteen (50%) PBRSAs involved cardiometabolic indications; 5 (19%) involved oncology indications; and 8 (31%) involved other indications. Categorized by health insurer or PBM, 10 (38%) PBRSAs involved large multistate insurers; 5 (19%) involved the Centers for Medicare & Medicaid Services; 7 (27%) involved regional insurers; 3 (12%) involved PBMs; and 1 (4%) involved multiple unspecified insurers. Regarding the most active drug manufacturers, Amgen initiated 5 (19%) PBRSAs and Novartis initiated 4 (15%). Relative to the initial FDA approval of a treatment, 15 (58%) PBRSAs were announced or initiated within 5 years, and 11 (42%) were announced or initiated more than 5 years later. For data collection, electronic medical record (EMR) data would have been an appropriate source for 12 (46%) PBRSAs; claims data would have been an appropriate source for 11 (42%) PBRSAs; and EMR and claims data would have been appropriate sources for 2 (8%) PBRSAs; no description of the outcome measures was available for 1 (4%) PBRSA. CONCLUSIONS: The number of publicly disclosed U.S.-specific PBRSAs for drugs has increased over the years. This review's findings confirm the interest of stakeholders in such arrangements and their confidence in the use of the selected outcome measures. Each PBRSA represents a timely collaboration among stakeholders to provide access to a drug while generating evidence to better elucidate its clinical and economic value. DISCLOSURES: No funding supported this systematic review. Yu is an employee and shareholder of Allergan. Chin reports personal fees from Formulary Resources. Oh and Farias have nothing to disclose. Study concept and design were primarily contributed by Yu, along with the other authors. All authors contributed to the collection and interpretation of the data. The manuscript was written by Yu, Chin, Oh, and Farias and revised by Yu and Chin, along with the other authors.

Healthcare burden of pulmonary hypertension owing to lung disease and/or hypoxia.

BACKGROUND: Group 3 pulmonary hypertension (PH) encompasses PH owing to lung diseases and/or hypoxia. Treatment patterns, healthcare resource use, and economic burden to US payers of Group 3 PH patients were assessed. METHODS: This retrospective observational study extracted data from July 1, 2010 to June 30, 2013 from two Truven Health Analytics MarketScan databases. Adult Group 3 PH patients were identified based on claims for PH (ICD-9-CM 416.0/416.8), a related lung disease, and an echocardiogram or right heart catheterization (RHC). The index date was the date of the first PH claim; data were collected for 12 months pre- and post-index. A difference-in-difference approach using generalized estimating equations was done to account for baseline differences. RESULTS: Group 3 PH patients (n = 2,236) were matched 1:1 to controls on lung disease. PH patients had higher all-cause resource utilization and annual healthcare costs ($44,732 vs. $7,051) than controls. Costs were driven by inpatient admissions (35.4% of total costs), prescriptions (33.0%), and outpatient care (26.5%). Respiratory-related costs accounted for 11.4% of post-index annual costs for PH patients. PH diagnosis was not confirmed in the majority of PH patients (<7% RHC use) but nevertheless, 22% of PH patients post-index had claims for drugs approved for the treatment of pulmonary arterial hypertension (PAH). CONCLUSIONS: Group 3 PH poses a significant clinical and economic burden. Given the low use of RHC and the prevalence of PAH-indicated prescriptions that are not currently approved for Group 3 PH, this study suggests some Group 3 PH patients may not be receiving guideline-recommended treatment.

The economic burden of common adverse events associated with metastatic colorectal cancer treatment in the United States.

AIMS: Adverse events (AEs) associated with treatments for metastatic colorectal cancer (mCRC) may compromise the course of treatment, impact quality-of-life, and increase healthcare resource utilization. This study assessed the direct healthcare costs of common AEs among mCRC patients in the US. METHODS: Adult mCRC patients treated with chemotherapy or targeted therapies were identified from administrative claims databases (2009-2014). Up to the first three mCRC treatment episodes per patient were considered and categorized as with or without the AE system/organ category during the episode. Total healthcare costs (2014 USD) were measured by treatment episode and reported on a monthly basis. Treatment episodes with the AE category were matched by treatment type and line of treatment to those without the AE category. Adjusted total cost differences were estimated by comparing costs during treatment episodes with vs without the AE category using multivariate regression models; p-values were estimated with bootstrap. RESULTS: A total of 4158 patients with ≥1 mCRC treatment episode were included (mean age = 59 years; 58% male; 60% with liver and 14% with lung metastases; 2,261 [54%] with a second and 1,115 [27%] with a third episode). On average, two treatment episodes were observed per patient with an average length of 166 days per episode. Adjusted monthly total cost difference by AE category included hematologic ($1,480), respiratory ($1,253), endocrine/metabolic ($1,213), central nervous system (CNS; $1,136), and cardiovascular ($1,036; all p < .05). LIMITATIONS: Claims do not include information on the cause of AEs, and potentially less severe AEs may not have been reported by the physician when billing the medical service. This study aimed to assess the association between costs and AEs and not the causation of AEs by treatment. CONCLUSIONS: The most costly AEs among mCRC patients were hematologic, followed by respiratory, endocrine/metabolic, CNS, and cardiovascular.

Indirect costs and workplace productivity loss associated with non-Hodgkin lymphoma.

The objective of this study was to examine indirect costs and workplace productivity loss (defined as an aggregate measure of absenteeism, short-term disability, and long-term disability days) associated with non-Hodgkin lymphoma (NHL) from a societal perspective in a commercially insured working-age United States population. The MarketScan(®) Commercial Claims and Encounters and Health and Productivity Management Databases (2007-2013) were used in this study, with controls matched 3:1 to NHL patients. In comparison to controls, NHL patients incurred significantly more workplace productivity loss (31.99 days; 95% CI: 25.24 days, 38.73 days; p < 0.001) and associated indirect costs ($6302.34; 95% CI: $4973.40, $7631.28; p < 0.001) in the 12-month post-diagnosis period when adjusting for covariates. NHL contributes significantly to losses in workplace productivity and higher associated indirect costs.