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BACKGROUND CONTEXT With the increasing emphasis on value-based healthcare in Centers for Medicare and Medicaid Services reimbursement structures, bundled payment models have been adopted for many orthopedic procedures. Immense variability of patients across hospitals and providers makes these models potentially less viable in spine surgery. Machine-learning models have been shown reliable at predicting patient-specific outcomes following lumbar spine surgery and could, therefore, be applied to developing stratified bundled payment schemes. PURPOSE (1) Can a Naive Bayes machine-learning model accurately predict inpatient payments, length of stay (LOS), and discharge disposition, following dorsal and lumbar fusion? (2) Can such a model then be used to develop a risk-stratified payment scheme? STUDY DESIGN A Naive Bayes machine-learning model was constructed using an administrative database. PATIENT SAMPLE Patients undergoing dorsal and lumbar fusion for nondeformity indications from 2009 through 2016 were included. Preoperative inputs included age group, gender, ethnicity, race, type of admission, All Patients Refined (APR) risk of mortality, APR severity of illness, and Clinical Classifications Software diagnosis code. OUTCOME MEASURES Predicted resource utilization outcomes included LOS, discharge disposition, and total inpatient payments. Model validation was addressed via reliability, model output quality, and decision speed, based on application of training and validation sets. Risk-stratified payment models were developed according to APR risk of mortality and severity of illness. RESULTS A Naive Bayes machine-learning algorithm with adaptive boosting demonstrated high reliability and area under the receiver-operating characteristics curve of 0.880, 0.941, and 0.906 for cost, LOS, and discharge disposition, respectively. Patients with increased risk of mortality or severity of illness incurred costs resulting in greater inpatient payments in a patient-specific tiered bundled payment, reflecting increased risk on institutions caring for these patients. We found that a large range in expected payments due to individuals’ preoperative comorbidities indicating an individualized risk-based model is warranted. CONCLUSIONS A Naive Bayes machine-learning model was shown to have good-to-excellent reliability and responsiveness for cost, LOS, and discharge disposition. Based on APR risk of mortality and APR severity of illness, there was a significant difference in episode costs from lowest to highest risk strata. After using normalized model error to develop a risk-adjusted proposed payment plan, it was found that institutions incur significantly more financial risk in flat bundled payment models for patients with higher rates of comorbidities.

Background: The FDA increasingly relies on medical device registries to help promote effective safety surveillance of high-risk medical devices in the US. However, there are limited uniform standards for how device registries should be organized or the data collected. Therefore, there may be substantial variability in registry implementation, which can reduce their utility to regulators. Objective: To survey the current landscape of US cardiovascular device registries and chart the extent of inconsistency in research goals, administration, enrollment procedures, and approach to data access. Methods: A systematic review using PRISMA guidelines was conducted to identify studies (1995-2017) referencing cardiovascular device registries with a US-based institution. Registries referenced in these studies were evaluated by reviewing associated manuscripts and websites. Data extracted for each registry included device type, primary scientific aim(s), funding, stewardship (e.g., administration of registry procedures), enrollment procedures, informed consent process, and mechanisms to access data for research. Results: The 138 cardiovascular device registries in the cohort ( TABLE ) covered devices addressing interventional cardiology (65.9%, 91/138), arrhythmias (15.2%, 21/138), heart failure (10.1%, 14/138), and valvular disease (10.1%, 14/138). While the majority (55.8%, 77/138) were industry-funded, stewardship was predominantly overseen by academic centers (74.0%, 102/138). Most registry participation was voluntary (77.5%, 107/138), but a substantial minority (20.3%, 28/138) were required as a condition of device implantation. Informed consent requirements varied widely, with written consent required in only 55.1% of registries. Registry data were primary accessible only to stewards (84.1%, 116/138), with 13.8% (19/138) providing pathways for external applications. Conclusion: The majority of cardiovascular device registries over the past two decades were funded privately under the auspices of academic institutions, which set the rules for data access. The substantial variation between cardiovascular device registries indicates a role for regulators to strengthen guidelines to improve quality, consistency, and ethical standards.

Use of platelet-rich-plasma (PRP) injections for treating knee osteoarthritis has increased over the past decade. We used cost-effectiveness analysis to evaluate the value of PRP in delaying the need for total knee arthroplasty (TKA).We developed a Markov model to analyze the baseline case: a 55-year-old patient with Kellgren-Lawrence grade-II or III knee osteoarthritis undergoing a series of 3 PRP injections with a 1-year delay to TKA versus a TKA from the outset. Both health-care payer and societal perspectives were included. Transition probabilities were derived from systematic review of 72 studies, quality-of-life (QOL) values from the Tufts University Cost-Effectiveness Analysis Registry, and individual costs from Medicare reimbursement schedules. Primary outcome measures were total costs and quality-adjusted life years (QALYs), organized into incremental cost-effectiveness ratios (ICERs) and evaluated against willingness-to-pay thresholds of $50,000 and $100,000. One and 2-way sensitivity analyses were performed as well as a probabilistic analysis varying PRP-injection cost, TKA delay intervals, and TKA outcomes over 10,000 different simulations.From a health-care payer perspective, PRP resulted in 14.55 QALYs compared with 14.63 for TKA from the outset, with total health-care costs of $26,619 and $26,235, respectively. TKA from the outset produced a higher number of QALYs at a lower cost, so it dominated. From a societal perspective, PRP cost $49,090 versus $49,424 for TKA from the outset. The ICER for TKA from the outset was $4,175 per QALY, below the $50,000 willingness-to-pay threshold. Assuming the $728 published cost of a PRP injection, no delay time that was10 years produced a cost-effective course. When the QOL value was increased from the published value of 0.788 to0.89, PRP therapy was cost-effective with even a 1-year delay to TKA.When considering direct and unpaid indirect costs, PRP injections are not cost-effective. The primary factor preventing PRP from being cost-effective is not the price per injection but rather a lack of established clinical efficacy in relieving pain and improving function and in delaying TKA. PRP may have value for higher-risk patients with high perioperative complication rates, higher TKA revision rates, or poorer postoperative outcomes.Economic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Injury to the scapholunate interosseous ligament is one of the most common causes of carpal instability and can impart considerable compromise to the patient's hand function. However, the management of scapholunate ligament injuries remains a dynamic concept, especially with regard to the multitude of options and techniques that exist for its surgical treatment. We present a thorough review of scapholunate anatomy and morphology, and the role of the scapholunate articulations in the kinetics and pathomechanics of wrist instability. We also review the current literature on the biomechanical properties of the scapholunate ligament and its subcomponents. A sound understanding of the anatomy and biomechanics of the scapholunate ligament can clarify its instability and may better orient current reconstructive procedures or pioneer better future techniques.

Background There is no consensus on the optimal fixation method for patients who require a surgical procedure for distal radial fractures. We used cost-effectiveness analyses to determine which of 3 modalities offers the best value: closed reduction and percutaneous pinning, open reduction and internal fixation, or external fixation. Methods We developed a Markov model that projected short-term and long-term health benefits and costs in patients undergoing a surgical procedure for a distal radial fracture. Simulations began at the patient age of 50 years and were run over the patient's lifetime. The analysis was conducted from health-care payer and societal perspectives. We estimated transition probabilities and quality-of-life values from the literature and determined costs from Medicare reimbursement schedules in 2016 U.S. dollars. Suboptimal postoperative outcomes were determined by rates of reduction loss (4% for closed reduction and percutaneous pinning, 1% for open reduction and internal fixation, and 11% for external fixation) and rates of orthopaedic complications. Procedural costs were $7,638 for closed reduction and percutaneous pinning, $10,170 for open reduction and internal fixation, and $9,886 for external fixation. Outputs were total costs and quality-adjusted life-years (QALYs), discounted at 3% per year. We considered willingness-to-pay thresholds of $50,000 and $100,000. We conducted deterministic and probabilistic sensitivity analyses to evaluate the impact of data uncertainty. Results From the health-care payer perspective, closed reduction and percutaneous pinning dominated (i.e., produced greater QALYs at lower costs than) open reduction and internal fixation and dominated external fixation. From the societal perspective, the incremental cost-effectiveness ratio for closed reduction and percutaneous pinning compared with open reduction and internal fixation was $21,058 per QALY and external fixation was dominated. In probabilistic sensitivity analysis, open reduction and internal fixation was cost-effective roughly 50% of the time compared with roughly 45% for closed reduction and percutaneous pinning. Conclusions When considering data uncertainty, there is only a 5% to 10% difference in the frequency of probability combinations that find open reduction and internal fixation to be more cost-effective. The current degree of uncertainty in the data produces difficulty in distinguishing either strategy as being more cost-effective overall and thus it may be left to surgeon and patient shared decision-making. Level of evidence Economic Level III. See Instructions for Authors for a complete description of levels of evidence.

A recent Food and Drug Administration (FDA) proposal aims to speed the evaluation process for new high-risk medical devices that are intended to address unmet medical needs,1 much like existing expedited approval processes, such as the humanitarian device exemption rule for devices intended to treat rare diseases. Such programs are strongly supported by the medical device industry and some patient advocacy groups, which have criticized the FDA for being too stringent in its evidentiary requirements for investigational devices, leading to delays in the approval of potentially helpful products.2–4 For example, in 2011, the FDA approved a transcatheter aortic valve replacement system that demonstrated significant improvements over conventional treatment options for selected patients with severe aortic stenosis.5,6 However, the United States was the 43rd country to approve the device, roughly 4 years after the European Union.7 Yet expedited approval for high-risk medical devices raises the possibility that these devices will not be as effective as predicted in their limited premarket testing or that they could cause unanticipated harms after approval.8 Of course, well-studied devices may present unexpected safety concerns years after approval,9,10 and even the most rigorous conventional premarket approval process will result in some devices later found to be unsafe or ineffective.11–13 Safety of approved medical devices and the proper scope of premarket testing remain contentious issues after recalls of several widely used devices, including popular models of implantable cardioverter defibrillator leads14,15 and metal-on-metal hip implants.16 Inherent limitations in premarket testing, along with the prospect of lowered evidentiary standards for expedited device reviews, place greater pressures on postapproval monitoring of devices to follow clinical performance and to identify emerging public health problems. Medical device manufacturers routinely perform this sort of vigilance, …

STUDY DESIGN Adult patients who received computed tomography (CT) alone or CT-magnetic resonance imaging (MRI) for the evaluation of cervical spine injury. OBJECTIVE To evaluate the utility of CT-MRI in the diagnosis of cervical spine injury using propensity-matched techniques. SUMMARY OF BACKGROUND DATA The optimal evaluation (CT alone vs. CT and MRI) for patients with suspected cervical spine injury in the setting of blunt trauma remains controversial. METHODS The primary outcome was the identification of a cervical spine injury, with decision for surgery and change in management considered secondarily. A propensity score was developed based on the likelihood of receiving evaluation with CT-MRI, and this score was used to balance the cohorts and develop two groups of patients around whom there was a degree of clinical equipoise in terms of the imaging protocol. Logistic regression was used to evaluate for significant differences in injury detection in patients evaluated with CT alone as compared to those receiving CT-MRI. RESULTS Between 2007 and 2014, 8060 patients were evaluated using CT and 693 with CT-MRI. Following propensity-score matching, each cohort contained 668 patients. There were no significant differences between the two groups in baseline characteristics. The odds of identifying a cervical spine injury were significantly higher in the CT-MRI group, even after adjusting for prior injury recognition on CT (odds ratios 2.6; 95% confidence interval 1.7-4.0; P

Objective The authors analyzed the frequency of occurrence of headaches in children and adolescents with Tourette syndrome (TS) to address their possible inclusion as a comorbidity. Study design Using a prospective questionnaire, administered directly, we interviewed a total sample size of 109 patients with TS ≤21 years of age. The questionnaires were then analyzed according to the International Headache Society’s diagnostic criteria. Results We found headaches to be present in 55% of the patients, with the 2 most common headache types being migraine headaches and tension-type headaches. The rate of migraine headache within the TS group was found to be 4 times greater than that of the general pediatric population, as reported in the literature. In addition, the rate of tension-type headache was found to be more than 5 times greater than that of the general pediatric population. Conclusions Overall, the high rates of migraine and tension-type headache within this population support the proposition that headaches are a comorbidity of TS.

Patients need active regulatory oversight, linked to compulsory post-marketing research As therapeutic options, medical devices differ from prescription drugs in many ways, but one of the most important is their potential for rapid evolution in basic design or technology. In the context of prescription drugs, it would be completely unreasonable to take a basic chemical structure, add another methyl group to it, and presume the drug would work the same (or better) without subjecting the new molecule to additional clinical testing. Medical devices, by contrast, change often. In a study published earlier this year, we found that cardiac implantable electronic devices approved in the US had a median of 50 applications to the Food and Drug Administration (FDA) for big and small changes over their median 15 year regulatory lifespans.1 In a linked paper (doi:10.1136/bmj.g5133), Nieuwenhuijse and colleagues provide important insights into the evidence base supporting new versions of hip and knee replacement devices.2 After conducting a systematic review of the literature and registry data, they found no good evidence of improved clinical outcomes for five widely used and marketed “advances” in hip and knee replacement technology, but they …