Primecuts-This Week in the Journals

July 6, 2017

800px-Lab_coatsBy David Rhee, MD
Peer Reviewed
A warm welcome to all the new interns! As the future of healthcare is debated in congress, there has been a great deal of attention on Medicaid and the Affordable Care Act (ACA). This week, our first two articles explore some of the effects Medicaid, Medicare, and the ACA had on patient outcomes either through the Hospital Value-Based Purchasing initiatives or through the growing use of observation units. Our third article reviews a study on non-vitamin K anticoagulation agents in low-risk patients with atrial fibrillation. Our last article analyzes the efficacy of yoga in treating chronic low back pain.

Changes in Hospital Quality Associated with Hospital Value-Based Purchasing

Let’s start with a Special Article recently published in the NEJM that looked into the outcomes of the ACA’s initiative of Hospital Value-Based Purchasing program. In the HVBP program, Medicare will withhold a certain amount of money (1-2% of the diagnosis-related group reimbursement) from the hospital that can be earned back if the hospital meets certain goals in healthcare metrics. These metrics include quality measure, patient experience, and cost of care. This was a major shift of payment models from the fee-for-service model to a value-based model.

Investigators from the University of Michigan explored the effects of this value-based payment model on healthcare outcomes in 2011-2015 in a study published this month in the NEJM[4]. The outcomes included improvement in clinical care/process, patient satisfaction, and 30-day mortality. They compared about 2000 acute-care hospitals exposed to HVBP against control hospitals (small rural hospitals that were not exposed).

They found that the outcomes in clinical care/process metrics and patient experience had similar improvement in both groups of hospitals (the difference-in-differences were 0.08 SD [95% CI, -0.14 to 0.30] and -0.09 SD [95% CI, -0.31 to 0.12] respectively). There were also no significant differences between the 30-day mortality rates for acute myocardial infarction and heart failure (difference-in-differences were -0.28 percentage points [95% CI, -1.72 to 1.15] and 0.21 percentage points [95% CI, -0.53 to 0.11] respectively). Of note, the mortality rate for pneumonia was higher in the control group (-0.43 percentage points [95% CI, -0.71 to -0.15]). In sum, the study suggests that HVBP did not result in meaningful improvements in clinical process, patient satisfaction, or a significant reduction in 30-day mortality. To better under why HVBP did not improve outcomes, the research group contrasted these findings against the effects of the ACA’s Hospital Readmission Reduction Program success on readmission rates. They suggest the HVBP may have a larger effect if there were more financial incentives and simplified performance criteria.

Outcomes after observation stays among older adult Medicare beneficiaries

Observation units, technically an outpatient service, were created to provide short-term treatment with frequent reassessments instead of a short-term inpatient hospitalization. They are generally reimbursed less than inpatient stays, but payers (such as Medicare and Medicaid) have implemented financial incentives to encourage observation stays rather than inpatient stays. As a result, they have become more prevalent and utilized over the past decade. In 2013, 1.5 million Medicare beneficiaries received care in an observation unit. However, the outcomes after discharges from these units are not well known.

In a study published in this week’s BMJ, a group of authors from Yale compiled 360,000 observation stays, 2,500,00 emergency room visits, and 2,600,000 inpatient admissions of Medicare patients over 65 in the years 2006-2011[5]. They compared the 30-day rates of emergency department treatment-and-stays, observation stays, inpatient stay, any hospital revisit, and mortality after a discharge from the observation unit with those after a discharge from the emergency department or an inpatient admission.

They found that the 30-day outcomes were similar between patients discharged from the observation unit and from the emergency department. The revisit rates were 20.1% and 19.9%, respectively, with a difference of 0.2% (95% CI, 0.1 to 0.3%). The mortality rates were 1.8% for discharges from both emergency rooms or observation units.). The outcomes after a discharge from an inpatient stay were worst (22% revisit and 5% mortality, with differences of 1.8% [95% CI, 1.6 to 1.9%] and 3.3% [95% CI, 3.3 to 3.4%] compared to discharges from an observation unit respectively).
In my interpretation of the study, it was encouraging that patients in observation units whose illness severity presumable lies somewhere between those discharged from the ED and those admitted as an inpatient had similar outcomes to ED patients rather than outcomes approaching those of patients being discharged from the inpatient admission. This suggests patients received adequate care while treated in an observation unit, but they would benefit more from improved transitional care during and after an ED discharge.

Effectiveness and Safety of Standard-Dose Non-vitamin K Antagonist Oral Anticoagulants and Warfarin Among Patients with Atrial Fibrillation With a Single Stroke Risk Factor

Prior studies comparing NOACs to warfarin have included high-risk patients with atrial fibrillation and 2 or more risk factors. Despite this, NOACs have been approved for use in low-risk patients. In a nationwide cohort study from Denmark, Lip GYH, et al. looked at the effectiveness and safety of such use in low-risk patients [6]. The study included14,000 Danish patients with atrial fibrillation and 1 CHA2DS2-VASc risk factor who were taking an oral anticoagulant. The primary outcome was rate of stroke/systemic embolization at 1 and 2.5 years of follow up, and they compared dabigatran, rivaroxaban, apixaban against warfarin. They found that there was no difference between the groups in overall occurrence of ischemic stroke or systemic embolism. (HR 0.81 [95% CI, 0.49-1.34], 1.46 [95% CI, 0.79-2.70], and 1.01 [0.51-2.01] respectively).

They also found significantly decreased mortality associated with the NOACs compared to warfarin (HR 0.47 [95% CI, 0.29-0.76] for apixaban, 0.59 [95% CI, 0.43-0.81] for dabigatran, and 0.52 [95% CI, 0.34-0.79] for rivaroxaban). However, based on their sensitivity analysis on this appeared mainly driven by intrinsic selective prescription patterns by physicians and warrants cautious interpretation. They also found significantly less bleeding with apixaban and dabigatran compared to warfarin (HR 0.35 [95% CI, 0.17-0.72] and 0.48 [95% CI, 0.30-0.77], respectively). This study was broadly consistent with many prior studies and suggested similar effectiveness of NOACs to warfarin with possibly a better safety profile. However, the study’s falsification end points generally did not falsify, suggesting that there was residual confounding across these analyses, presumably related to selective prescribing and unobserved comorbidities. This is a large limitation of this study.

Yoga, Physical Therapy, or Education for Chronic Low Back Pain

Chronic low back pain is the leading cause of disability worldwide. Increasingly, yoga is being offered as an alternative treatment method to traditional physical therapy, however no studies have assessed its effectiveness. A group in Boston performed a randomized non-inferiority trial of 320 predominantly low-income patients with nonspecific, chronic low back pain to assess the effectiveness of yoga [7]. Patients were randomized into one of three groups: one received weekly yoga classes, another received PT visits, and the last received educational printouts (self-care book and newsletters).
The primary outcomes (back-related function measured by the Roland Morris Disability Questionnaire [RMDQ] and pain) were obtained after a 12-week treatment phase, and periodically during a subsequent 40-week maintenance phase. Improvements in the RMDQ or pain index for yoga were non-inferior to those for PT (mean differences -0.26 [1-sided CI, -∞ to 0.83] and 0.51 [1-sided CI, -∞ to 0.97]) at 12 weeks. Both yoga and PT were more likely to have clinically meaningful responses in RMDQ than the education group (odds ratios 3.1 [95% CI, 1.6 to 6.2] and 2.0 [95% CI, 1.0 to 4.0] respectively) and less likely to use pain medications (odds ratios 0.36 [95% CI, 0.17 to 0.78] and 0.31 [95% CI, 0.14 to 0.67]. The follow-up data during the maintenance phase, while reported in the supplemental materials as overall similar to the 12-week results, appears limited by dropouts and nonadherence.
Fewer than half of participants met adherence criteria of at least 70% attendance (44% in yoga, 36% in PT, and 44% in education) despite the classes being free and surveys being financially incentivized. While yoga classes (based on a specific 12-week program initially developed by Boston Medical Center) appear to be a viable therapy option for chronic low back pain, I remain concerned that the patients I see will have significant barriers to access any yoga classes.

Bioresorbable Scaffolds
Now, they are making stents that are bioresorbable. Are these effective? Are they safe? This group from the Netherlands compared the outcomes from 1,800 patients who received either a drug-eluting bioresorbable stent or a drug-eluting metallic stent[8].

Morning Report
Call me sentimental, but it’s the end of a year. For some, the first year as a doctor — for others, the last as a resident. Dr. Singh tells a story of a morning when she was a medicine intern at Stanford [9].

Moral Dilemma
Another vivid tale, this time by a surgical resident in Iraq who is trapped between a young female decompensating from a tension pneumothorax and a conservative surrogate who refuses to let him touch the patient [10].

David Rhee, MD is a second year internal medicine resident at NYU Langone Medical Center
Peer Reviewed by Ian Henderson, MD Associate Editor, Clinical Correlations
Image courtesy of Wikimedia Commons

[1] Park H, Sanger-Katz M. How Senate Republicans Plan to Dismantle Obamacare. The New York Times. 2017 Jun 22. Accessed June 25,2017.
[1] April 2017 Medicaid and CHIP Enrollment Data Highlights. Centers for Medicare & Medicaid Services. Accessed June 25, 2017.
[2] Sanger-Katz M. G.O.P. Health Plan is Really a Rollback of Medicaid. The New York Times. 2017 Jun 20. Accessed June 25, 2017.
[3] Martin J, Burns A. Republican Senator Vital to Health Bill’s Passage Won’t Support It. The New York Times. 2017 Jun 23. Accessed June 25, 2017.
[4] Ryan AM, Krinsky S, Maurer KA, Dimick JB. Changes in Hospital Quality Associated with Hospital Value-Based Purchasing. NEJM. 2017 Jun 15; 376:2358-2366.
[5] Dharmarajan K, et al. Outcomes after observation stay among older adult Medicare beneficiaries in the USA: retrospective cohort study. BMJ. 2017 Jun 20; 357:j2616.
[6] Lip GYH, et al. Effectiveness and Safety of Standard-Dose Nonvitamin K Antagonist Oral Anticoagulants and Warfarin Among Patients With Atrial Fibrillation With a Single Stroke Risk Factor: A Nationwide Cohort Study. JAMA Cardiology. 2017 Jun 14 [Epub ahead of print]. Accessed June 25, 2017.
[7] Saper RB, et al. Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial. Annals of Internal Medicine. 2017 Jun 20 [Epub ahead of print]. Accessed June 25, 2017.
[8] Wykrzykowska JJ, et al. Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. NEJM. 2017 Jun 15; 376:2319-2328.
[9] Singh S. Morning Report. NEJM. 2017 Jun 15; 376:2316-1317.
[10] Al-Shamsi M. Moral Dilemma in the ER. Annals of Internal Medicine. 2017 Jun 20; 166(12):909-910.

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