https://www.ahajournals.org/doi/10.1161/STROKEAHA.118.020971?platform=hootsuite
Originally published5 Jul 2018Stroke. 2018;49:1933-1938
Abstract
Background and Purpose—
The 2015 updated US Food and Drug Administration alteplase package insert altered several contraindications. We thus explored clinical factors influencing alteplase treatment decisions for patients with minor stroke.Methods—
An expert panel selected 7 factors to build a series of survey vignettes: National Institutes of Health Stroke Scale (NIHSS), NIHSS area of primary deficit, baseline functional status, previous ischemic stroke, previous intracerebral hemorrhage, recent anticoagulation, and temporal pattern of symptoms in first hour of care. We used a fractional factorial design (150 vignettes) to provide unconfounded estimates of the effect of all 7 main factors, plus first-order interactions for NIHSS. Surveys were emailed to national organizations of neurologists, emergency physicians, and colleagues. Physicians were randomized to 1 of 10 sets of 15 vignettes, presented randomly. Physicians reported the subjective likelihood of giving alteplase on a 0 to 5 scale; scale categories were anchored to 6 probabilities from 0% to 100%. A conjoint statistical analysis was applied.Results—
Responses from 194 US physicians yielded 156 with complete vignette data: 74% male, mean age 46, 80% neurologists. Treatment mean probabilities for individual vignettes ranged from 6% to 95%. Treatment probability increased from 24% for NIHSS score =1 to 41% for NIHSS score =5. The conjoint model accounted for 25% of total observed response variance. In contrast, a model accounting for all possible interactions accounted for 30% variance. Four of the 7 factors accounted jointly for 58% of total relative importance within the conjoint model: previous intracerebral hemorrhage (18%), recent anticoagulation (17%), NIHSS (13%), and previous ischemic stroke (10%).Conclusions—
Four main variables jointly account for only a small fraction (<15%) of the total variance related to deciding to treat with intravenous alteplase, reflecting high variability and complexity. Future studies should consider other variables, including physician characteristics.Introduction
The activase/alteplase package insert from the Food and Drug Administration was updated in February 2015.1 Several previous contraindications were modified. However, the new wording has not precisely defined specific criteria for a decision to treat or not with intravenous alteplase. Limited data exist on alteplase use with prior contraindications (based on exclusions from the National Institute for Neurological Disorders r-tPA [recombinant tissue-type plasminogen activator] Stroke Trials).2 We thus explored factors that may influence a physician’s decision to use intravenous alteplase, focusing on the more controversial area of treating minor stroke, defined as National Institutes of Health Stroke Scale (NIHSS) score 1 to 5, through a survey targeting physicians that commonly treat acute stroke patients.3,4Methods
In compliance with the American Heart Association Journals’ implementation of the Transparency and Openness Promotion Guidelines, the data that support the findings of this study are available from the corresponding author on reasonable request.Selection of Treatment Decision Factors
A Study Steering Committee (SSC; Appendix I in the online-only Data Supplement) composed of national stroke experts (including both vascular neurologists and emergency medicine physicians) who participated in the TREAT (Reexamining Acute Eligibility for Thrombolysis) Task Force focusing on minor/rapidly improving stroke5 identified key factors in decision-making about alteplase use. The SSC initially suggested 52 patient-specific factors (Appendix II in the online-only Data Supplement) as well as 16 physician/hospital factors. The 52 patient factor list was reviewed and reduced to 20 factors using Delphi consensus-building methodology6–8; the physician/hospital factor list was reduced to 12 in a similar manner (Appendix III in the online-only Data Supplement). The SSC prioritized what they considered the most salient patient factors. An NIHSS score of 1 to 5, stroke features (primary sphere of neurological deficit), and temporal course would be included to mimic the original design of the pilot survey on alteplase decision-making for minor stroke.9Based on statistical considerations and sample size, and to prevent respondent fatigue, it was determined that 4 additional patient factors could be explored. These were identified from those most commonly selected by the SSC in the second round of Delphi voting: anticoagulation use (9/10 SSC members in favor); recent intracerebral hemorrhage (ICH; 9/10); recent ischemic stroke (IS; 9/10); and baseline functional status (BFS; 5/10). Two additional factors, intravenous alteplase treatment window time 0 to 3 versus 3 to 4.5 hours and patient’s preference about disability, also had 5 of 10 members in favor of inclusion, but were ultimately excluded for statistical reasons, similarity to other factors (baseline status versus preference), or because they were outside the scope of practice (intravenous alteplase beyond 3 hours from symptom onset is currently off-label in the United States). Physician respondent characteristics were pared down similarly.
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