Platelet transfusion guidelines

Free full text published in the Annals of Internal Medicine.

VA physician and staff satisfaction with performance measures

From a recent JGIM study:

OBJECTIVE:

To describe primary care staff (clinicians and other staff) experiences with the use of performance metrics during the implementation of the Veterans Health Administration's (VHA) Patient Aligned Care Team (PACT) model of care...

PARTICIPANTS:

Two hundred and forty-one of 337 (72 %) identified primary care clinic staff in PACT team and clinic administrative/other roles, from 15 VHA clinics in Oregon and Washington...

KEY RESULTS:

Primary care staff perceived that performance metrics: 1) led to delivery changes that were not always aligned with PACT principles, 2) did not accurately reflect patient-priorities, 3) represented an opportunity cost, 4) were imposed with little communication or transparency, and 5) were not well-adapted to team-based care.

CONCLUSIONS:

Primary care staff perceived responding to performance metrics as time-consuming and not consistently aligned with PACT principles of care. The gaps between the theory and reality of performance metric implementation highlighted by PACT team members are important to consider as the medical home model is more widely implemented.

The VA is a stellar health system in the artificial world of metrics.

Non cardiac surgery after stroke and time course of increased risk

From a recently published Danish nationwide cohort study:

Main Outcomes and Measures Risk of major adverse cardiovascular events (MACE; including ischemic stroke, acute myocardial infarction, and cardiovascular mortality) and all-cause mortality up to 30 days after surgery. Odds ratios (ORs) were calculated by multivariable logistic regression models.

Results Crude incidence rates of MACE among patients with (n = 7137) and without (n = 474 046) prior stroke were 54.4 (95% CI, 49.1-59.9) vs 4.1 (95% CI, 3.9-4.2) per 1000 patients. Compared with patients without stroke, ORs for MACE were 14.23 (95% CI, 11.61-17.45) for stroke less than 3 months prior to surgery, 4.85 (95% CI, 3.32-7.08) for stroke 3 to less than 6 months prior, 3.04 (95% CI, 2.13-4.34) for stroke 6 to less than 12 months prior, and 2.47 (95% CI, 2.07-2.95) for stroke 12 months or more prior. MACE risks were at least as high for low-risk (OR, 9.96; 95% CI, 5.49-18.07 for stroke less than 3 months) and intermediate-risk (OR, 17.12; 95% CI, 13.68-21.42 for stroke less than 3 months) surgery compared with high-risk surgery (OR, 2.97; 95% CI, 0.98-9.01 for stroke less than 3 months) (P = .003 for interaction). Similar patterns were found for 30-day mortality: ORs were 3.07 (95% CI, 2.30-4.09) for stroke less than 3 months prior, 1.97 (95% CI, 1.22-3.19) for stroke 3 to less than 6 months prior, 1.45 (95% CI, 0.95-2.20) for stroke 6 to less than 12 months prior, and 1.46 (95% CI, 1.21-1.77) for stroke 12 months or more prior to surgery compared with patients without stroke. Cubic regression splines performed on the stroke subgroup supported that risk leveled off after 9 months.

Conclusions and Relevance A history of stroke was associated with adverse outcomes following surgery, in particular if time between stroke and surgery was less than 9 months. After 9 months, the associated risk appeared stable yet still increased compared with patients with no stroke. The time dependency of risk may warrant attention in future guidelines.

Maintenance of certification (MOC): a focus group study of physicians' perceptions

Published in JAMA Internal Medicine:

At present, MOC is perceived by physicians as an inefficient and logistically difficult activity for learning or assessment, often irrelevant to practice, and of little benefit to physicians, patients, or society.

The Sunshine Act and the war on physicians

Great post on this topic over at Kevin MD.

Perioperative atrial fibrillation and long term stroke risk

Perioperative a fib is often transient and considered benign. But a recent study from a large claims database suggests a long term stroke risk:

Main Outcomes and Measures Previously validated diagnosis codes were used to identify ischemic strokes after discharge from the index hospitalization for surgery. The primary predictor variable was atrial fibrillation newly diagnosed during the index hospitalization, as defined by previously validated present-on-admission codes. Patients were censored at postdischarge emergency department encounters or hospitalizations with a recorded diagnosis of atrial fibrillation.

Results Of 1 729 360 eligible patients, 24 711 (1.43%; 95% CI, 1.41%-1.45%) had new-onset perioperative atrial fibrillation during the index hospitalization and 13 952 (0.81%; 95% CI, 0.79%-0.82%) experienced a stroke after discharge. At 1 year after hospitalization for cardiac surgery, cumulative rates of stroke were 0.99% (95% CI, 0.81%-1.20%) in those with perioperative atrial fibrillation and 0.83% (95% CI, 0.76%-0.91%) in those without atrial fibrillation. At 1 year after noncardiac surgery, cumulative rates of stroke were 1.47% (95% CI, 1.24%-1.75%) in those with perioperative atrial fibrillation and 0.36% (95% CI, 0.35%-0.37%) in those without atrial fibrillation. In a Cox proportional hazards analysis accounting for potential confounders, perioperative atrial fibrillation was associated with subsequent stroke both after cardiac surgery (hazard ratio, 1.3; 95% CI, 1.1-1.6) and noncardiac surgery (hazard ratio, 2.0; 95% CI, 1.7-2.3). The association was significantly stronger for perioperative atrial fibrillation after noncardiac vs cardiac surgery (P less than  .001 for interaction).

We have no way of knowing the duration of a fib in these patients but, likely, many episodes were transient.

Gruber on lack of transparency

No elaboration needed.

Via Health Care BS.

Perioperative beta blockers: an update

The pendulum regarding perioperative beta blockers has been swinging. Nevertheless, evidence accumulated during this time offers reasonable guidance for clinicians. Via CCJM.

Surgery in patients taking new (target specific) oral anticoagulants

From a recent review in CCJM:

While various periprocedural protocols for TSOAC therapy have been proposed, evidence-based guidelines are still to come.

The article summarizes the current thinking. It gives a nice summary of the pharmacokinetics and pharmacodynamics, and practical information for the perioperative period. A guide for timing of discontinuation of TSOACs prior to surgery is found in this table.

The risk of GI bleeding associated with SSRIs with and without NSAIDs

Here are the findings of a recent systematic review and meta-analysis:

RESULTS: Fifteen case–control studies (including 393,268 participants) and four cohort studies were included in the analysis. There was an increased risk of upper GI bleeding with SSRI medications in the case–control studies (OR=1.66, 95% CI=1.44,1.92) and cohort studies (OR=1.68, 95% CI=1.13,2.50). The number needed to harm for upper GI bleeding with SSRI treatment in a low-risk population was 3,177, and in a high-risk population it was 881. The risk of upper GI bleeding was further increased with the use of both SSRI and NSAID medications (OR=4.25, 95% CI=2.82,6.42).

CONCLUSIONS: SSRI medications are associated with a modest increase in the risk of upper GI bleeding, which is lower than has previously been estimated. This risk is significantly elevated when SSRI medications are used in combination with NSAIDs, and physicians prescribing these medications together should exercise caution and discuss this risk with patients.

More evidence that dabigatran increases the risk of MI

From a recent meta-analysis:

Background Signals of an increased risk of myocardial infarction (MI) have been identified with dabigatran etexilate in randomized controlled trials (RCTs).

Methods and Resules We conducted searches of the published literature and a clinical trials registry maintained by the drug manufacturer. Criteria for inclusion in our meta‐analysis included all RCTs and the availability of outcome data for MI, other cardiovascular events, major bleeding, and all‐cause mortality. Among the 501 unique references identified, 14 RCTs fulfilled the inclusion criteria. Stratification analyses by comparators and doses of dabigatran etexilate were conducted. Peto odds ratio (ORPETO) values using the fixed‐effect model (FEM) for MI, other cardiovascular events, major bleeding, and all‐cause mortality were 1.34 (95% CI 1.08 to 1.65, P=0.007), 0.93 (95%CI 0.83 to 1.06, P=0.270), 0.88 (95% CI 0.79 to 0.99, P=0.029), and 0.89 (95% CI 0.80 to 1.00, P=0.041). When compared with warfarin, ORPETO values using FEM were 1.41 (95% CI 1.11 to 1.80, P=0.005), 0.94 (95%CI 0.83 to 1.06, P=0.293), 0.85 (95% CI 0.76 to 0.96, P=0.007), and 0.90 (95% CI 0.81 to 1.01, P=0.061), respectively. In RCTs using the 150‐mg BID dosage, the ORPETO values using FEM were 1.45 (95% CI 1.11 to 1.91, P=0.007), 0.95 (95% CI 0.82 to 1.09, P=0.423), 0.92 (95% CI 0.81 to 1.05, P=0.228), and 0.88 (95% CI 0.78 to 1.00, P=0.045), respectively. The results of the 110‐mg BID dosage were mainly driven by the RE‐LY trial.

Conclusions This meta‐analysis provides evidence that dabigatran etexilate is associated with a significantly increased risk of MI. This increased risk should be considered taking into account the overall benefit in terms of major bleeding and all‐cause mortality.

The data analysis is complex and it is helpful to read the body of the paper (free full test), particularly Table 2, for clarity.

Pertusis

Reviewed in Chest.

Heart failure performance and outcomes

Here's a recent paper in JACC with some interesting findings:

Methods We assessed rates of compliance with care measures for patients hospitalized with acute or chronic heart failure in the ARIC (Atherosclerosis Risk In Communities) study surveillance catchment area from 2005 to 2009. Rates of compliance were compared between patients with a principal discharge diagnosis of heart failure and those with another principal discharge diagnosis.

I interject here to point out this important distinction. If the primary diagnosis is heart failure the hospital is under the “report card” and financial incentive of the heart failure performance measures. If the heart failure patient is discharged under a different primary diagnosis (with heart failure as a secondary) the hospital is not under the incentive. Keep that in mind in reading the results:

Results Of 4,345 hospitalizations of heart failure patients, 39.6% carried a principal diagnosis of heart failure. Patients with a principal heart failure diagnosis had higher rates of LV function assessment (89.1% vs. 82.5%; adjusted prevalence ratio [aPR]: 1.07; 95% confidence interval [CI]: 1.04 to 1.10) and discharge ACE inhibitor/angiotensin receptor blocker (ARB) in LV dysfunction (64.1% vs. 56.3%; aPR: 1.11; 95% CI: 1.03 to 1.20) as compared to patients hospitalized for another cause. LV assessment and ACE inhibitor/ARB use were associated with reductions in 1-year post-discharge mortality (adjusted odds ratio: 0.66, 95% CI: 0.51 to 0.85; adjusted odds ratio: 0.72, 95% CI: 0.54 to 0.96, respectively) that did not differ for patients with versus without a principal heart failure diagnosis.

So if heart failure is the principal diagnosis and the performance game is in play, participants adhere at a higher rate. That isn't surprising. What surprised me is that the differences were not greater. More interesting to me, though, was the improvement in outcomes associated with following the measures. On the one hand the finding is intuitive; after all, the administration of neurohumeral antagonists guided by assessment of ventricular function is evidence based and would be expected to help patients. On the other hand it is a new finding, in disagreement with prior research, which failed to show that such inherently beneficial and evidence based therapies made a difference in outcomes when associated with performance incentives.

As expressed many times here on the blog, I have a contrarian view of performance measures. This study doesn't change that view much. ACEIs and ARBs seemed to help patients whether their prescription was performance driven or not. The performance driven population (those with a primary diagnosis of heart failure) reflected slightly higher utilization than the comparison group and one could therefore infer that the incentive drove a modest reduction in mortality. Moreover, the idea is plausible. However, as cited in an accompanying editorial, the finding is in contrast to the prior body of research, not only for heart failure but across the whole range of performance measures.

Therein lies the conundrum: take an evidence based treatment (one proven in clinical trials to be beneficial), put it in a public incentive package and it no longer seems to work. The reason is that the way performance is structured, providers are incented to game the system mainly through coding and charting. That, they have discovered, is where the low hanging fruit is for reimbursement and favorable public reporting. Thus performance is not a valid surrogate for quality, either as a driver of patient care or a way to measure it.

A process improvement tool for acute pancreatitis

From a recent article in the American Journal of Gastroenterology:

METHODS: Design/Setting: Observational study, entitled, The AP Early Response (TAPER) Project. Tertiary center emergency department (ED) and hospital. Participants: Two consecutive samplings of patients having ICD-9 code (577.0) for AP were generated from the emergency department (ED) or hospital admissions. Diagnosis of AP was based on conventional Atlanta criteria. The Pre-TAPER-CDS-Tool group (5/30/06–6/22/07) had 110 patients presenting to the ED with AP per 976 ICD-9 (577.0) codes and the Post-TAPER-CDS-Tool group (5/30/06–6/22/07) had 113 per 907 ICD-9 codes (7/14/10–5/5/11).

Intervention: The TAPER-CDS-Tool, developed 12/2008–7/14/2010, is a combined early, automated paging-alert system, which text pages ED clinicians about a patient with AP and an intuitive web-based point-of-care instrument, consisting of seven early management recommendations.

RESULTS: The pre- vs. post-TAPER-CDS-Tool groups had similar baseline characteristics. The post-TAPER-CDS-Tool group met two management goals more frequently than the pre-TAPER-CDS-Tool group: risk stratification (P less than 0.0001) and intravenous fluids greater than 6L/1st 0–24 h (P=0.0003). Mean (s.d.) hospital LOS was significantly shorter in the post-TAPER-CDS-Tool group (4.6 (3.1) vs. 6.7 (7.0) days, P=0.0126). Multivariate analysis identified four independent variables for hospital LOS: the TAPER-CDS-Tool associated with shorter LOS (P=0.0049) and three variables associated with longer LOS: Japanese severity score (P=0.0361), persistent organ failure (P=0.0088), and local pancreatic complications (less than 0.0001).

CONCLUSIONS: The TAPER-CDS-Tool is associated with changed clinician behavior and shortened hospital LOS, which has significant financial implications.

Methamphetamine cardiomyopathy (MAC)

Here are some key points from a review:

MAC is a newly emerging entity and is somewhat poorly understood.

It appears to be mainly a dilated cardiomyopathy (systolic dysfunction).

It appears to be reversible upon cessation of the ingestion, acknowledging that there may be a point in time of irreversibility.

It is believed to be catecholamine mediated and as such has features in common with stress cardiomyopathy, including pathologic findings of contraction band necrosis.

Should patient satisfaction ever be 100%?

That could be dangerous! Great post and fascinating comment thread over at The Happy MD.

Procalcitonin guided therapy in critically ill patients

Shorter lengths of stay, shorter durations of antibiotic therapy at no cost in terms of outcome, in this study.

Do doctors find MOC helpful? Is it important to patients?

Not according to this survey.

Severity assessment in pulmonary embolism: a need for consistency

As it does for many conditions, severity assessment of pulmonary embolism guides treatment. Severity assessment for PE is more important than ever these days because treatment options have multiplied. There are now many more decision points than we had just a few years ago. Now under discussion, for example, is the question of which patients can be discharged early or even undergo the entirety of their treatment as outpatients. The approval of target specific oral anticoagulants adds another decision point. Which patients with PE are candidates for those agents? Recent discussions have asked the question of whether there exists a subset of patients with acute PE who don't need to be treated at all. A clinical trial now in progress seeks to address that question. The question regarding how long to anticoagulate patients for secondary prevention is not as open and shut as it was just a few years ago. This is illustrated by a reading of the most recent ACCP guidelines. The same is true regarding indications for IVC filters. Meanwhile the debate about selection of patients for thrombolytic therapy rages on and has recently been complicated by promising studies looking at half dose thrombolytic therapy for a variety of patients with pulmonary embolism.

For us to make sense of all the new evidence and treatment options severity classification becomes important. The problem is this area is evolving too and has become inconsistent across the published literature. I'm going to be blogging about some of the new treatment options in the near future. But in order to have a meaningful discussion it is first important to define the terms of severity classification. What follows is my attempt to review some of the history of PE classification and outline the topic as it stands now, however confusing.

Back in the day it was pretty simple. The binary decision was whether to treat conventionally (with unfractionated or low molecular weight heparin) or to use thrombolytic therapy. It was based on whether the PE was associated with normal blood pressure or hypotension respectively. PE with hypotension correlated with obliteration of 50% or more of the activity on radionuclide perfusion scanning, which was an ancillary criterion. There followed a rising awareness of patients who were normotensive but had a large clot burden and evidence of acute right ventricular dysfunction as measured by biomarkers and/or imaging which consisted usually of echocardiograhy as well, in some centers, as ascertainment of the ratio of right ventricular to left ventricular diameter on CT angiography. With the addition of this intermediate category we then had 3 categories which became known as massive, submassive and hemodynamically normal.

Treatment discussions regarding pulmonary embolism have centered around this classification. For massive PE there has been a fairly strong consensus in favor of thrombolytic therapy in the absence of contraindications. Submassive PEs are the subject of controversy with divided opinion on whether to treat with thrombolysis or conventional heparin therapy with the weight of opinion favoring the latter. Hemodynamically uncomplicated PEs according to the recent thinking are those that could be treated with conventional anticoagulation and considered for early discharge or even outpatient treatment.

With the publication of recent papers suggesting yet another treatment method, half dose thrombolytic in conjunction with anticoagulation, the discussion has been complicated further because these papers have used yet another classification, which stratifies pulmonary emboli into severe, moderate and (by implication) mild forms. The problem is, this new classification does not translate well into the traditional one because it uses criteria (mainly anatomic) that are not analogous. This is illustrated by the MOPETT trial and the more recent drip, dose and discharge (DDD) paper. Here are the definitions form the DDD paper:

Moderate PE was regarded as presence of symptoms plus objective evidence of PE, defined as 70% involvement of a pulmonary artery or 2 lobar or 4 segmental branches plus hemodynamic stability. Severe PE was defined as systolic blood pressure less than of equal to100 mm Hg plus all other features of moderate PE; saddle pulmonary embolism; or involvement of greater than 70% of the main pulmonary artery (PA) with thrombus, irrespective of blood pressure.

MOPETT did not define severe PE because those patients were not studied. The definition of moderate PE was along the same lines as in DDD with a slight variation:

“Moderate” PE was defined as the presence of signs and symptoms of PE plus computed tomographic pulmonary angiographic involvement of greater than 70% involvement of thrombus in greater than or equal to 2 lobar of left or right main pulmonary arteries or by a high probability ventillation/perfusion scan showing ventillation/perfusion mismatch in greater than or equal to two lobes.

In order to have a meaningful discussion of the rapidly emerging literature and treatment options for pulmonary embolism it is important to keep these definitions in mind. In the future we need some sort of a consensus.

Neuraminidase inhibitors for influenza: what does the evidence really show?

This has been the subject of controversy. Here is an evidence summary published in a recent issue of the Annals of Energency Medicine. From the article:

This Cochrane review demonstrates that oseltamivir shortens symptom duration by 21 hours in patients who receive the drug within 48 hours of symptom onset. Unfortunately, there is little information that can be inferred from current available data about hospitalization rates and neuraminidase inhibitors’ effectiveness in decreasing transmission rates of the influenza virus. However, the CDC continues to recommend neuraminidase inhibitors, using information based on observational studies that showed decreased hospital stays and severe outcomes such as ICU admissions or death in patients treated with oseltamivir.3

In the past, Cochrane reviews examining the effect of neuraminidase inhibitors were based on published clinical studies conducted by drug manufacturers; however, these studies were found to reflect only a small portion of the trials conducted and bore discrepancies with their clinical study report counterparts. For the first time in Cochrane history, this review attempted to remove the reporting bias seen in the previous reviews by analyzing the unpublished regulatory data from clinical study reports rather than relying on the published trials.4 Unfortunately, despite major efforts by the systematic review authors, they were unable to obtain much of the data from trials sponsored by the drug manufacturers.

So we have high level data in support of NI based on soft outcomes (time to symptom relief) and low level data in support of them for hard outcomes (severe complications, death). The debate about this has been heated and overhyped. The final answer is that it depends on your evidence quality threshold, your preferences and your values.