Marilyn Rymer

Patient-Centered Decision Support in Acute Ischemic Stroke: Qualitative Study of Patients' and Providers' Perspectives.

Background—National guidelines endorse recombinant tissue-type plasminogen activator (r-tPA) in eligible patients with acute ischemic stroke to improve patients’ functional recovery. However, 23% to 40% of ideal candidates with acute ischemic stroke for reperfusion are not treated, perhaps because of the difficulty in explaining the benefits and risks of r-tPA within the frenetic pace of emergency department care. To support better knowledge transfer and creation of a shared decision-making tool, we conducted qualitative interviews to define the information needs and preferred presentation format for stroke survivors, caregivers, and clinicians considering r-tPA treatment. Methods and Results—A multidisciplinary team used qualitative research methods to identify informational needs and strategies for describing the benefits and risks of r-tPA in a clinical setting. Through focus groups (n=10) of stroke survivors (n=39) and caregivers (n=24) and individual interviews with emergency physicians (n=23) and advanced practice nurses (n=20), several themes emerged. Survivors and caregivers preferred a broader definition of a good outcome (independence, rather than no significant disability), simpler graphs as compared with detailed pictographs, and presentation of both population and individualized benefits (framed positively) and risk of receiving r-tPA. Some physicians expressed skepticism with the data and the ability to present risk/benefit information emergently, whereas other physicians and most advanced practice nurses thought such information would improve care. Physicians stressed the importance of presenting the risk of thrombolytic-related intracranial hemorrhage. Conclusions—This study suggests that a positively framed risk–benefit tool with graphical presentations of general and patient-specific risk estimates could support patients and providers in considering r-tPA for acute ischemic stroke. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01864928.

Selecting Patients for Intra-Arterial Therapy in the Context of a Clinical Trial for Neuroprotection.

Background and Purpose— The advent of intra-arterial neurothrombectomy (IAT) for acute ischemic stroke opens a potentially transformative opportunity to improve neuroprotection studies. Combining a putative neuroprotectant with recanalization could produce more powerful trials but could introduce heterogeneity and adverse event possibilities. We sought to demonstrate feasibility of IAT in neuroprotectant trials by defining IAT selection criteria for an ongoing neuroprotectant clinical trial. Methods— The study drug, 3K3A-APC, is a pleiotropic cytoprotectant and may reduce thrombolysis-associated hemorrhage. The NeuroNEXT trial NN104 (RHAPSODY) is designed to establish a maximally tolerated dose of 3K3A-APC. Each trial site provided their IAT selection criteria. An expert panel reviewed site criteria and published evidence. Finally, the trial leadership designed IAT selection criteria. Results— Derived selection criteria reflected consistency among the sites and comparability to published IAT trials. A protocol amendment allowing IAT (and relaxed age, National Institutes of Health Stroke Scale, and time limits) in the RHAPSODY trial was implemented on June 15, 2015. Recruitment before and after the amendment improved from 8 enrolled patients (601 screened, 1.3%) to 51 patients (821 screened, 6.2%; odds ratio [95% confidence limit] of 4.9 [2.3–10.4]; P<0.001). Gross recruitment was 0.11 patients per site month versus 0.43 patients per site per month, respectively, before and after the amendment. Conclusions— It is feasible to include IAT in a neuroprotectant trial for acute ischemic stroke. Criteria are presented for including such patients in a manner that is consistent with published evidence for IAT while still preserving the ability to test the role of the putative neuroprotectant. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT02222714.

Pitfalls in the Diagnosis of Low-Back and Leg Pain

Disk disease is a causative factor in only 22.3% of patients with low-back and leg pain. Tumors, peripheral nerve lesions, vascular lesions, and infections are other causes that are occasionally missed in diagnosis. The case reports presented here illustrate diagnostic pitfalls to be avoided.

Organizing Stroke Systems of Care

To the Editor: I read with great interest the American Stroke Association (ASA) policy recommendation entitled Recommendations for the Establishment of Stroke Systems of Care.1 It is encouraging to see that this task force validates the recommendations from the 2 symposia sponsored by the National Institute of Neurological Disorders and Stroke held in 1997 and 2002.2,3⇓ There appears to be consensus on what systems need to be in place to optimally prevent and treat stroke. The challenge lies in effective implementation. Approximately 9 years after the Food and Drug Administration approved intravenous tissue plasminogen activator (IV tPA), the number of patients treated annually has not increased. It appears that simply agreeing on what should happen does not make it so. The ASA’s Task Force set forth 5 general recommendations for stroke systems,1 but there is no clear description of who or what is organizing this comprehensive “systems” approach. The NINDS task force also emphasized the “need to link and coordinate the activities of providers, concluding that a stroke system should fundamentally be a single entity that is responsible for organizing the stroke system”3 without helping us understand who that “single entity” is. It …

Outpatient Low-Molecular Weight Heparin for Conversion to Warfarin in Non-Valvular Atrial Fibrillation

P206 Background: Patients with non-valvular atrial fibrillation (NVAF) are often hospitalized on IV heparin until target INRs are achieved. SQ LMWH has been shown to be safe and effective for OP treatment of DVT, but has not been widely used in NVAF. We discharged 35 patients with NVAF on SQ LMWH and analyzed safety, cost and satisfaction. Methods: Patients with NVAF who were being held in the hospital only for conversion of heparin to warfarin and who met other entry criteria were enrolled. Baseline CBC, coagulation profile, neurologic exam and demographic data were obtained. Patients were instructed in the use of LMWH and warfarin and then discharged on dalteparin 100 units/kgm BID. Ten patients also chose to monitor their own INRs with a point of care testing device (Coagucheck). Eight patients elected to have a home health nurse administer the dalteparin. When two consecutive INRs were therapeutic, dalteparin was discontinued. Actual cost of outpatient care was calculated. Inpatient costs were projected based on the number of days it took to reach the therapeutic INR values. Ten days after enrollment patients responded to a phone survey regarding thrombotic and/or bleeding complications, readmission to ED or hospital and satisfaction. Results: 31 patients completed the entire process. 51%(18/35) were >70 years old. There were no significant thrombotic or bleeding complications, no readmissions and one ED visit for minor bleeding at a venupuncture site (INR=2.5). 71%(22/31) reported minor bruising. Patients using Coagucheck monitored INRs 2x as frequently as patients using the lab. Outpatient costs including the cost of dalteparin, INR testing, home health visits, coagucheck supplies and 1 ED visit totaled

Antithrombotic Therapy in Stroke Prevention and Treatment: A Review

20,324 or

Organizing regional networks to increase acute stroke intervention

616 per patient. Projected inpatient costs including the cost of room, IV heparin, PTT and INR testing totaled

Protective Adaptation of Brain to Water Intoxication

123,261 or

Hemorrhagic stroke: intracerebral hemorrhage.

3,735 per patient. This represented a cost saving of

Hemorrhagic stroke: aneurysmal subarachnoid hemorrhage.

3,119 per patient. 91%(28/31) were satisfied or very satisfied with the OP treatment and 87%(27/31)reported they would use it again. Conclusions: Outpatient SQ LMWH is a safe, cost-effective and attractive alternative to inpatient IV heparin in patients with NVAF.