Severe Lenke 1 and 2 adolescent idiopathic scoliosis had poorer perioperative outcome, higher complication rate, longer fusion and higher operative cost compared to non-severe scoliosis.

PURPOSE: To compare the perioperative outcome and operative cost of posterior spinal fusion (PSF) surgery between severe and non-severe Lenke 1 and 2 adolescent idiopathic scoliosis (AIS) patients. METHODS: A total of 509 AIS patients who underwent single-staged PSF between 2013 and 2020 were reviewed. Fifty-four severe scoliosis patients (Cobb angle ≥ 90°) were categorized into Gp1, and 455 non-severe scoliosis (Cobb angle < 90°) patients into Gp2. Propensity score matching (PSM) analysis using one-to-one nearest neighbor matching and match tolerance of 0.001 were performed. Outcome measures were operative time, intraoperative blood loss (IBL), allogeneic transfusion rate, perioperative complication, length of stay, fusion level, number of screws used, postoperative Cobb angle, correction rate (CR), side bending correction index (SBCI) and operative cost. RESULTS: From the PSM analysis, 35 patients from each group were matched. The operative time was 155.9 ± 41.4 and 130.0 ± 30.3 min for Gp1 and Gp2, respectively (p = 0.004). The IBL was 1349.2 ± 1019.0 and 781.9 ± 325.1 mLs for Gp1 and Gp2, respectively (p = 0.003). Fusion level (12.5 ± 0.8 vs. 11.2 ± 1.3, p < 0.001) and number of screws used (16.4 ± 1.6 vs. 14.6 ± 1.4, p < 0.001) were higher in Gp1. Four perioperative complications were observed in Gp1 compared to none in Gp2 (p < 0.039). Gp1 had larger postoperative Cobb angle (p < 0.001), lower CR (p = 0.005) and higher SBCI (p < 0.001). The operative cost was higher in Gp1 (p < 0.001). CONCLUSIONS: Severe Lenke 1 and 2 AIS patients had poorer perioperative outcome, higher complication rate, longer fusion and higher operative cost than non-severe AIS.

A conceptual framework for evaluation of community pharmacy pay-for-performance programs.

BACKGROUND: Recent interest in initiating pay-for-performance (P4P) programs indicates an underlying belief that economic incentives will have a direct impact on health care quality and efficiency. Evaluations of the impact of P4P programs on health care organizations and providers have been presented in the literature; however, none have focused on the impact of an incentive targeting community pharmacies. OBJECTIVE: To propose a theory-derived conceptual framework of how a financial incentive might work in a community pharmacy. METHODS: Studies from the fields of economics (agency theory), psychology (intrinsic and extrinsic motivators; expectancy theory), and organizational theory (ownership, institutional layers, organizational culture, and change management; quality improvement) were reviewed to inform the framework's components. This proposed conceptual framework also integrated and expanded on previous health care-related P4P models. RESULTS: P4P programs inherently use financial incentives to catalyze change; however, elements from psychology and organizational theories along with economic theory were identified as important considerations in how a financial incentive may operate when targeting a community pharmacy. Through the incorporation of these theories along with other P4P frameworks in health care, a conceptual framework was derived comprising 4 domains: incentive, pharmacy, other influencing factors, and P4P program measures. Hypothesized relationships among these domains were depicted. CONCLUSION: As focus on improving the quality of health care provision develops, opportunities for pharmacists to provide patient care services beyond dispensing will continue to advance, along with expanded reimbursement mechanisms extending beyond traditional product dispensing. The proposed theory-derived conceptual framework serves to depict how the integration of P4P and other factors may affect the pharmacy environment and subsequently affect a pharmacy's capability to perform well on medication-related quality measures. This framework may be used as a foundation on which to design studies to investigate the association between community pharmacy factors and performance in a P4P program.

Ex vivo assessment of erythrocyte tolerance to the HeartWare ventricular assist device operated in three discrete configurations.

Despite technological advances in ventricular assist devices (VADs) to treat end-stage heart failure, hemocompatibility remains a constant concern, with supraphysiological shear stresses an unavoidable reality with clinical use. Given that impeller rotational speed is related to the instantaneous shear within the pump housing, it is plausible that the modulation of pump speed may regulate peak mechanical shear stresses and thus ameliorate blood damage. The present study investigated the hemocompatibility of the HeartWare HVAD in three configurations typical of clinical applications: standard systemic support left VAD (LVAD), pediatric support LVAD, and pulmonary support right VAD (RVAD) conditions. Two ex vivo mock circulation blood loops were constructed using explanted HVADs, in which pump speed and external loop resistance were manipulated to reflect the flow rates and differential pressures reported in configurations for standard adult LVAD (at 3150 rev⸱min-1 ), pediatric LVAD (at 2400 rev⸱min-1 ), and adult RVAD (at 1900 rev⸱min-1 ). Using bovine blood, the mock circulation blood loops were tested at 37°C over a period of 6 hours (consistent with ASTM F1841-97) and compared with static control. Hemocompatibility assessments were conducted for each test condition, examining hematology, hemolysis (absolute and normalized index), osmotic fragility, and blood viscosity. Regardless of configuration, continuous exposure of blood to the VAD over the 6-hour period significantly altered hematological and rheological blood parameters, and induced increased hemolysis when compared with a static control sample. Comparison of the three operational VAD configurations identified that the adult LVAD condition-associated with the highest pump speed, flow rate, and differential pressure across the pump-resulted in increased normalized hemolysis index (NIH; 0.07) when compared with the lower pump speed "off-label" counterparts (NIH of 0.04 in pediatric LVAD and 0.01 in adult RVAD configurations). After normalizing blood residence times between configurations, pump speed was identified as the primary determinant of accumulated blood damage; plausibly, blood damage could be limited by restricting pump speed to the minimum required to support matched cardiac output, but not beyond.

The Economic Burden of End-Organ Damage Among Medicaid Patients with Sickle Cell Disease in the United States: A Population-Based Longitudinal Claims Study.

BACKGROUND: The management of sickle cell disease (SCD), an inherited, chronic, and multifaceted condition, is associated with considerable health care resource utilization (HRU) and costs, especially for Medicaid. Anemia affects most patients with SCD and correlates with end-organ damage (EOD), such as stroke, chronic kidney disease (CKD), end-stage renal disease (ESRD), and pulmonary hypertension (PH). Limited research has been conducted to quantify the economic burden of EOD among patients with SCD. OBJECTIVE: To estimate the effect of EOD on HRU and direct costs and productivity loss incurred by patients with SCD on Medicaid. METHODS: Patients with ≥ 3 nondiagnostic SCD ICD-9-CM/ICD-10-CM codes in ≤ 5 years (January 1, 2013-December 31, 2017) were identified in the MarketScan Medicaid claims database. The earliest SCD diagnosis date was the index date. Continuous enrollment at least 3 months before and 1 month after the index date were required. Patients' post-index periods were divided into 3-month intervals (referred to as "intervals"). History of stroke, CKD, ESRD, and PH were identified in patients' claims histories from January 1, 2008. Intervals within 1 year and more than 1 year after an acute stroke event were also defined. All-cause HRU, direct costs, and productivity losses were summed across intervals and stratified by EOD type. Multivariate regression models were used to estimate the effect of stroke, CKD, ESRD, and PH on annual total cost, inpatient days, and number of emergency department visits by controlling for patients' demographic characteristics and other SCD complications. RESULTS: In total, 10,784 Medicaid patients with SCD (average age: 18.5 years; female: 54.5%) contributed to 152,455 intervals. Approximately 12% of the intervals had EOD. Patients with EOD had higher all-cause health care costs and more inpatient days, emergency department visits, outpatient visits, laboratory tests, and outpatient pharmacy claims than patients without EOD. After controlling for patient characteristics, among Medicaid patients with SCD annual costs within 1 year after stroke were 4.68-fold versus patients with no EOD (more than 1 year after stroke: 2.08-fold; CKD: 2.19-fold; ESRD: 3.40-fold; PH: 2.32-fold). Adjusted mean annual costs for adult patients with SCD on Medicaid were $285,816 and $127,393 within 1 year and more than 1 year after stroke and $135,493, $209,172, and $148,174 for CKD, ESRD, and PH, respectively. Patients with multiple SCD complications had even higher costs. The mean annual time patients with SCD spent receiving health care services ranged from 56 to 62 days for those with EOD versus 21 to 25 days among those without EOD, which created additional economic burden. CONCLUSIONS: When Medicaid patients with SCD experience EOD, the economic burden is significantly increased through direct costs to the health care system and indirect costs from productivity loss to society. SCD management strategies that potentially reduce the risk of EOD offer clinical and economic value to patients and society. DISCLOSURES: Funding for this study was provided by Global Blood Therapeutics (GBT). Campbell is a consultant for GBT, Bluebird Bio, and Cyclerion and receives research funding from Novartis, GBT, and Cyclerion. Cong and Agodoa are employees of and have equity ownership in GBT. Song, Martinez, Black, Lew, Varker, and Chan are employees of IBM Watson Health, which received research funding from GBT for this study. Lanzkron receives research funding from GBT, Pfizer, Ironwood, HRSA, and NIH. A poster based on this study was presented at the 61st ASH Annual Meeting and Exposition; December 7-10, 2019; Orlando, FL.

Controversies with nonoperative management for adolescent idiopathic scoliosis: Study from the APSS Scoliosis Focus Group.

PURPOSE: To determine consensus among Asia-Pacific surgeons regarding nonoperative management for adolescent idiopathic scoliosis (AIS). METHODS: An online REDCap questionnaire was circulated to surgeons in the Asia-Pacific region during the period of July 2019 to September 2019 to inquire about various components of nonoperative treatment for AIS. Aspects under study included access to screening, when MRIs were obtained, quality-of-life assessments used, role of scoliosis-specific exercises, bracing criteria, type of brace used, maturity parameters used, brace wear regimen, follow-up criteria, and how braces were weaned. Comparisons were made between middle-high income and low-income countries, and experience with nonoperative treatment. RESULTS: A total of 103 responses were collected. About half (52.4%) of the responders had scoliosis screening programs and were particularly situated in middle-high income countries. Up to 34% obtained MRIs for all cases, while most would obtain MRIs for neurological problems. The brace criteria were highly variable and was usually based on menarche status (74.7%), age (59%), and Risser staging (92.8%). Up to 52.4% of surgeons elected to brace patients with large curves before offering surgery. Only 28% of responders utilized CAD-CAM techniques for brace fabrication and most (76.8%) still utilized negative molds. There were no standardized criteria for brace weaning. CONCLUSION: There are highly variable practices related to nonoperative treatment for AIS and may be related to availability of resources in certain countries. Relative consensus was achieved for when MRI should be obtained and an acceptable brace compliance should be more than 16 hours a day.

Flexibility assessment of the unfused thoracic segments above the "potential upper instrumented vertebrae" using the supine side bending radiographs in Lenke 5 and 6 curves for adolescent idiopathic scoliosis patients.

BACKGROUND CONTEXT: Selection of upper instrumented vertebra for Lenke 5 and 6 curves remains debatable, and several authors have described different selection strategies. OBJECTIVE: This study analyzed the flexibility of the unfused thoracic segments above the "potential upper instrumented vertebrae (UIV)" (T1-T12) and its compensatory ability in Lenke 5 and 6 curves using supine side bending (SSB) radiographs. STUDY DESIGN: A retrospective study was used. PATIENT SAMPLE: This study comprised 100 patients. OUTCOME MEASURES: The ability of the unfused thoracic segments above the potential UIV, that is, T1-T12, to compensate in Lenke 5 and 6 curves was determined. We also analyzed postoperative radiological outcome of this cohort of patients with a minimum follow-up of 12 months. METHODS: Right and left SSB were obtained. Right side bending (RSB) and left side bending (LSB) angles were measured from T1 to T12. Compensatory ability of thoracic segments was defined as the ability to return to neutral (center sacral vertical line [CSVL]) with the assumption of maximal correction of lumbar curve with a horizontal UIV. The Lenke 5 curves were classified as follows: (1) Lenke 5-ve (mobile): main thoracic Cobb angle <15° and (2) Lenke 5+ve (stiff): main thoracic Cobb angle 15.0°-24.9°. This study was self-funded with no conflict of interest. RESULTS: There were 43 Lenke 5-ve, 31 Lenke 5+ve, and 26 Lenke 6 curves analyzed. For Lenke 5-ve, >70% of thoracic segments were able to compensate when UIV were at T1-T8 and T12 and >50% at T9-T11. For Lenke 5+ve, >70% at T1-T6 and T12, 61.3% at T7, 38.7% at T8, 3.2% at T9, 6.5% at T10, and 22.6% at T11 were able to compensate. For Lenke 6 curve, >70% at T1-T6, 69.2% at T7, 19.2% at T8, 7.7% at T9, 0% at T10, 3.8% at T11, and 34.6% at T12 were able to compensate. There was a significant difference between Lenke 5-ve versus Lenke 5+ve and Lenke 5-ve versus Lenke 6 from T8 to T11. There were no significance differences between Lenke 5+ve and Lenke 6 curves from T1 to T11. CONCLUSIONS: The compensatory ability of the unfused thoracic segment of Lenke 5+ve curves was different from the Lenke 5-ve curves, and it demonstrated characteristics similar to the Lenke 6 curves.

Single vs two attending senior surgeons: assessment of intra-operative blood loss at different surgical stages of posterior spinal fusion surgery in Lenke 1 and 2 adolescent idiopathic scoliosis.

PURPOSE: To assess the pattern of intra-operative blood loss at various surgical stages comparing between single and two surgeons. METHODS: Lenke 1 and 2 adolescent idiopathic scoliosis (AIS) patients who underwent instrumented posterior spinal fusion (PSF) surgery from two centres between June 2014 and December 2015 were prospectively recruited into this study. The patients were grouped into Group 1 (single surgeon) and Group 2 (two surgeons). One to one matching using 'prospective propensity score-matched cohort patient sampling method' was done. The surgery was divided into six stages: stage 1-exposure, stage 2-screw insertion, stage 3-release, stage 4-correction, stage 5-corticotomies and bone grafting and stage 6-closure. RESULTS: A total of 116 patients were recruited. Of 86 patients who were operated by the two surgeons, 30 patients were matched with 30 patients that were operated by a single surgeon. Operation duration was significantly longer in Group 1 (257.3 ± 51.4 min) compared to Group 2 (164.0 ± 25.7 min). The total blood loss was significantly higher in Group 1 (1254.7 ± 521.5 mL) compared to Group 2 (893.7 ± 518.4 mL). Total blood loss/level fused was significantly higher in Group 1 (117.5 ± 42.8 mL/level) compared to Group 2 (82.6 ± 39.4 mL/level). Group 1 had significantly higher blood loss and blood loss/level fused for stages 1, 2 and 3. Group 2 had lower incidence of allogenic blood transfusion. CONCLUSIONS: In PSF surgery for AIS patients, two-surgeon strategy was associated with shorter operation duration, lesser blood loss and lower incidence of allogenic blood transfusion.

Assessment of Intraoperative Blood Loss at Different Surgical Stages During Posterior Spinal Fusion Surgery in the Treatment of Adolescent Idiopathic Scoliosis.

STUDY DESIGN: Prospective clinical study. OBJECTIVE: To analyze the amount of blood loss at different stages of Posterior Instrumented Spinal Fusion (PSF) surgery in adolescent idiopathic scoliosis (AIS) patients. SUMMARY OF BACKGROUND DATA: Knowing the pattern of blood loss at different surgical stages may enable the surgical team to formulate a management strategy to reduce intraoperative blood loss. METHODS: One hundred AIS patients who underwent PSF from January 2013 to December 2014 were recruited. The operation was divided into six stages; stage 1-exposure, stage 2-screw insertion, stage 3-release, stage 4-correction, stage 5-corticotomies and bone grafting, and stage 6-closure. The duration and blood loss at each stage was documented. The following values were calculated: total blood loss, blood loss per estimated blood volume, blood loss per minute, blood loss per vertebral level fused, and blood loss per minute per vertebral level fused. RESULTS: There were 89 females and 11 males. The mean age was 17.0 ±â€Š5.8 years old. Majority (50.0%) were Lenke 1 curve type. The mean preoperative major Cobb angle was 64.9 ±â€Š15.0°. The mean number of levels fused was 9.5 ±â€Š2.3 levels. The mean operating time was 188.5 ±â€Š53.4 minutes with a mean total blood loss 951.0 ±â€Š454.0 mLs. The highest mean blood loss occurred at stage 2 (301.0 ±â€Š196.7 mL), followed by stage 4 (226.8 ±â€Š171.2 mL) and stage 5 (161.5 ±â€Š146.6 mL). The highest mean blood loss per minute was at stage 5 (17.1 ±â€Š18.3 mL/min), followed by stage 3 (12.0 ±â€Š10.8 mL/min). The highest mean blood loss per vertebral levels fused was at stage 2 (31.0 ±â€Š17.7 mL/level), followed by stage 4 (23.9 ±â€Š18.1 mL/level) and stage 5 (16.6 ±â€Š13.3 mL/level). CONCLUSION: All stages were significant contributors to the total blood loss except exposure (stage 1) and closure (stage 6). Blood loss per minute and blood loss per minute per level was highest during corticotomies (stage 5), followed by release (stage 3). However, the largest amount of total blood loss occurred during screw insertion (stage 2). LEVEL OF EVIDENCE: 2.

Specialty Payment Model Opportunities and Assessment: Gastroenterology and Cardiology Model Design Report.

Gastroenterology and cardiology services are common and costly among Medicare beneficiaries. Episode-based payment, which aims to create incentives for high-quality, low-cost care, has been identified as a promising alternative payment model. This article describes research related to the design of episode-based payment models for ambulatory gastroenterology and cardiology services for possible testing by the Center for Medicare and Medicaid Innovation at the Centers for Medicare and Medicaid Services (CMS). The authors analyzed Medicare claims data to describe the frequency and characteristics of gastroenterology and cardiology index procedures, the practices that delivered index procedures, and the patients that received index procedures. The results of these analyses can help inform CMS decisions about the definition of episodes in an episode-based payment model; payment adjustments for service setting, multiple procedures, or other factors; and eligibility for the payment model.

Specialty Payment Model Opportunities and Assessment: Oncology Model Design Report.

This article describes research related to the design of a payment model for specialty oncology services for possible testing by the Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services (CMS). Cancer is a common and costly condition. Episode-based payment, which aims to create incentives for high-quality, low-cost care, has been identified as a promising alternative payment model for oncology care. Episode-based payment systems can provide flexibility to health care providers to select among the most effective and efficient treatment alternatives, including activities that are not currently reimbursed under Medicare payment policies. However, the model design also needs to ensure that high-quality care is delivered and that beneficial treatments are not withheld from patients. CMS asked MITRE and RAND to conduct analyses to inform design decisions related to an episode-based oncology model for Medicare beneficiaries undergoing chemotherapy treatment for cancer. In particular, this study focuses on analyses of Medicare claims data related to the definition of the initiation of an episode of chemotherapy, patterns of spending during and surrounding episodes of chemotherapy, and attribution of episodes of chemotherapy to physician practices. We found that the time between the primary cancer diagnosis and chemotherapy initiation varied widely across patients, ranging from one day to over seven years, with a median of 2.4 months. The average level of total monthly payments varied considerably across cancers, with the highest spending peak of $9,972 for lymphoma, and peaks of $3,109 for breast cancer and $2,135 for prostate cancer.

Specialty Payment Model Opportunities and Assessment: Oncology Simulation Report.

This article describes the results of a simulation analysis of a payment model for specialty oncology services that is being developed for possible testing by the Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services (CMS). CMS asked MITRE and RAND to conduct simulation analyses to preview some of the possible impacts of the payment model and to inform design decisions related to the model. The simulation analysis used an episode-level dataset based on Medicare fee-for-service (FFS) claims for historical oncology episodes provided to Medicare FFS beneficiaries in 2010. Under the proposed model, participating practices would continue to receive FFS payments, would also receive per-beneficiary per-month care management payments for episodes lasting up to six months, and would be eligible for performance-based payments based on per-episode spending for attributed episodes relative to a per-episode spending target. The simulation offers several insights into the proposed payment model for oncology: (1) The care management payments used in the simulation analysis-$960 total per six-month episode-represent only 4 percent of projected average total spending per episode (around $27,000 in 2016), but they are large relative to the FFS revenues of participating oncology practices, which are projected to be around $2,000 per oncology episode. By themselves, the care management payments would increase physician practices' Medicare revenues by roughly 50 percent on average. This represents a substantial new outlay for the Medicare program and a substantial new source of revenues for oncology practices. (2) For the Medicare program to break even, participating oncology practices would have to reduce utilization and intensity by roughly 4 percent. (3) The break-even point can be reduced if the care management payments are reduced or if the performance-based payments are reduced.

Reevaluation of the Harboe assay as a standardized method of assessment for the hemolytic performance of ventricular assist devices.

The Harboe spectrophotometric assay is regarded as one of the safest and most reproducible methods for measuring plasma free hemoglobin (pfHb). However, there is still some ambiguity in the application of the assay when assessing the hemolytic performance of ventricular assist devices (VADs). The purpose of this study was to reexamine and compare values of pfHb obtained using different concentrations of plasma diluent (Na(2) CO(3) ) as cited by various studies such that a standard practice may be recommended for the application of the Harboe assay in the hemolytic evaluation of VADs, allowing reliable comparisons to be made between laboratories. As a means to examine the Harboe assay, a BioMedicus BPX-80 was tested using both whole blood and a washed suspension of red blood cells (RBCs). Results show that for whole blood, the pfHb may be underestimated by 13-23%, dependent upon the concentration of Na(2) CO(3) diluent solution. This trend was not observed for the washed suspension of RBCs. Furthermore, it is shown that the concentration of diluent influences the stability of a sample. The results of this study show that the problems associated with the incongruity of pfHb readings are a direct result of the precipitation of proteins from the plasma under alkaline conditions; as the molarity of the diluent controls pH, it becomes essential to use the appropriate concentration of Na(2) CO(3) diluent in order to avoid turbidity of the solution and the consequent misrepresentation of pfHb values. Such standardization is pertinent when measuring the very low levels of pfHb observed during the in vivo testing of modern ventricular assist devices.

Radiological assessment of cervical lateral mass screw angulations in Asian patients.

BACKGROUND: Various lateral mass screw fixation methods have been described in the literature with various levels of safety in relation to the anterior neurovascular structures. This study was designed to radiologically determine the minimum lateral angulations of the screw to avoid penetration of the vertebral artery canalusing three of the most common techniques: Roy-Camille, An, and Magerl. MATERIALS AND METHODS: Sixty normal cervical CT scans were reviewed. A minimum lateral angulation of a 3.5 mm lateral mass screw which was required to avoid penetration of the vertebral artery canal at each level of vertebra were measured. RESULTS: The mean lateral angulations of the lateral mass screws (with 95% confidence interval) to avoid vertebral artery canal penetration, in relation to the starting point at the midpoint (Roy-Camille), 1 mm medial (An), and 2 mm medial (Magerl) to the midpoint of lateral mass were 6.8° (range, 6.3-7.4°), 10.3° (range, 9.8-10.8°), and 14.1° (range, 13.6-14.6°) at C3 vertebrae; 6.8° (range, 6.2-7.5°), 10.7° (range, 10.0-11.5°), and 14.1° (range, 13.4-14.8°) at C4 vertebrae; 6.6° (range, 6.0-7.2°), 10.1° (range, 9.3-10.8°), and 13.5° (range, 12.8-14.3°) at C5 vertebrae and 7.6° (range, 6.9-8.3°), 10.9° (range, 10.3-11.6°), and 14.3° (range, 13.7-15.0°) at C6 vertebrae. The recommended lateral angulations for Roy-Camille, Magerl, and An are 10°, 25°,and 30°, respectively. Statistically, there is a higher risk of vertebral foramen violation with the Roy-Camille technique at C3, C4 and C6 levels, P < 0.05. CONCLUSIONS: Magerl and An techniques have a wide margin of safety. Caution should be practised with Roy-Camille's technique at C3, C4, and C6 levels to avoid vertebral vessels injury in Asian population.