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Harold P Adams

Publications and source records attributed to Harold P Adams.

At least 19 recordsLinked to original sources
PubMed2006

Feasibility of acute clinical trials during aerial interhospital transfer.

BACKGROUND AND PURPOSE: In rural America, patients are often first seen at a small community hospital and then transferred to a tertiary care center by helicopter for further care. If acute clinical research were feasible during the aerial interhospital transport, more patients might be enrolled in trials at a critical earlier stage. METHODS: Prospective data were collected for all aerial transfers of a university-based helicopter service from April 2005 to January 2006. Flight nurses were educated about stroke research and offered certification and participation. Data collected included patient characteristics and the availability of relatives to provide surrogate consent. RESULTS: All 12 flight nurses completed the institutional review board certification requirements and collected data on 215 transfers. Sixty-one patients had acute stroke or myocardial events (MIs). The median time from symptom onset to helicopter arrival at an outside hospital was 213 minutes (range, 90 to 2135) for ischemic stroke (n=12), 186 (45 to 1332) for intracranial hemorrhage (n=28), and 157 (47 to 1044) for MI (n=21). A relative was available in >74% of those transfers. A trial with a 4-hour window would permit enrollment of 67% of the ischemic strokes, 82% of intracranial hemorrhage cases, and 76% of MI patients. CONCLUSIONS: Clinical trials are feasible during aerial interhospital transport of patients. Flight nurses became successful investigators in clinical research and were exposed to potentially eligible patients with the ability to consent either directly or through surrogates. This approach could improve current clinical trial recruitment in rural areas, as well as permit testing of inflight ancillary interventions to improve outcome during patient transport.

Acute Disease↗
PubMed2006

National Stroke Association guidelines for the management of transient ischemic attacks.

OBJECTIVE: Transient ischemic attacks are common and important harbingers of subsequent stroke. Management varies widely, and most published guidelines have not been updated in several years. We sought to create comprehensive, unbiased, evidence-based guidelines for the management of patients with transient ischemic attacks. METHODS: Fifteen expert panelists were selected based on objective criteria, using publication metrics that predicted nomination by practitioners in the field. Prior published guidelines were identified through systematic review, and recommendations derived from them were rated independently for quality by the experts. Highest quality recommendations were selected and subsequently edited by the panelists using a modified Delphi approach with multiple iterations of questionnaires to reach consensus on new changes. Experts were provided systematic reviews of recent clinical studies and were asked to justify wording changes based on new evidence and to rate the final recommendations based on level of evidence and quality. No expert was allowed to contribute to recommendations on a topic for which there could be any perception of a conflict of interest. RESULTS: Of 257 guidelines documents identified by systematic review, 13 documents containing 137 recommendations met all entry criteria. Six iterations of questionnaires were required to reach consensus on wording of 53 final recommendations. Final recommendations covered initial management, evaluation, medical treatment, surgical treatment, and risk factor management. INTERPRETATION: The final recommendations on the care of patients with transient ischemic attacks emphasize the importance of urgent evaluation and treatment. The novel approach used to develop these guidelines is feasible, allows for rapid updating, and may reduce bias.

Health Planning Guidelines↗
PubMed2006

Lessons from adult stroke trials.

Before designing epidemiologic, genetic, or treatment trials in pediatric stroke, we should learn from adult trials which preceded. Adult trialists state that there is a need for improved animal models to mimic human disease. Dose-response curves with blinded outcome measures would improve preclinical data. Functional and histologic outcome measures would improve the animal model. In regard to human Phase 2 medication trials, safety, delivery, end points, and surrogate markers are necessary. The detection of biologic activity can be defined in Phase 2B trials. For Phase 3 trials, the experiment needs to be simple with global outcome measures as end points. New statistical designs such as futility analysis may improve and streamline trials in both adults and children. Clinical trials are a long process, and care needs to be incorporated at every step. Why is there a propensity of failed studies for acute ischemic stroke in adults? The reasons include (a) the animal model fails us, (b) the Phase 2 trials are ineffective in defining dose, and (c) the Phase 3 trials are poorly done. Because clinical trials, more often than not, fail to give positive (effective treatment) results, it seems reasonable to attempt to learn from others' past experiences before initiating pediatric stroke trials.

Adult↗
PubMed2004

Vascular neurology: a new neurologic subspecialty.

This article presents information about the American Board of Psychiatry and Neurology's new subspecialty certificate in vascular neurology, including the requirements for board certification. Practicing neurologists and child neurologists who have a major focus in vascular neurology can apply for the new certificate. In addition, the Accreditation Council for Graduate Medical Education has approved fellowship training in the subspecialty, and it is likely that residents who wish to pursue a career in vascular neurology will select this training option.

Adult↗
PubMed2004

Can we predict early recurrence in acute stroke?

BACKGROUND: The prevention of early recurrent stroke, which worsens outcomes after a cerebral infarction, is a major objective for acute stroke therapy. The ability to predict which patients are at risk for early recurrence would be useful for both the management and design of clinical trials. METHODS: Using the prospective database with the 1,266 stroke patients admitted in the TOAST study, we analyzed all the patients who had suffered either a transient ischemic attack (TIA) or a recurrent stroke within 3 months after stroke, and their possible association with 20 selected clinical variables. Both univariate and stepwise regression analyses were performed. RESULTS: Sixty-two patients (4.9%) had a second stroke, and 47 patients (3.7%) had at least one TIA. No particular high-risk period was observed. Early recurrent stroke was associated with the large artery atherosclerosis subtype. A prior history of TIA increased the odds for recurrent stroke (OR = 2.52; 1.16-5.46) or poststroke TIA (OR = 3.46; 1.59-7.48). In addition, patients who had a TIA after the stroke had a 17% chance of having an early recurrent stroke, as compared with 4.4% among those that did not (p = 0.001). CONCLUSION: Our present ability to identify patients at risk for early recurrence based on baseline clinical features remains limited. While the presence of TIA before or after the stroke denotes a subgroup of acute stroke patients at higher risk for early recurrence in the first 3 months, no other factors reliably identify high-risk patients.

Acute Disease↗
PubMed2004

Measuring outcomes as a function of baseline severity of ischemic stroke.

BACKGROUND: The spectrum of neurological impairments following acute ischemic stroke is broad. The initial stroke severity predicts responses to treatment and outcomes after ischemic stroke. While clinical trials are using baseline severity as an enrollment criterion or a stratified variable, adjustment of outcome measures as a function of initial impairments has not been done. METHODS: We developed a responder analysis that defines favorable outcomes at 90 days as influenced by the baseline National Institutes of Health Stroke Scale (NIHSS). Favorable outcome was defined as a modified Rankin Scale (mRS) score of 0 if the baseline NIHSS score was <8, mRS score of 0-1 if the NIHSS score was 8-14, and mRS score of 0-2 if the NIHSS score was >14. The concept stemmed from the data of two European rtPA trials. The analysis is a predefined secondary endpoint in a trial testing abciximab. We also used the analysis to reexamine the Trial of Org 10172 in Acute Stroke Treatment data. RESULTS: The responder analysis did not change the overall results of any of the 3 previous trials, but it did give information about differences in responses among subgroups of patients. Evidence about the potential utility of tPA for treatment of patients with mild stroke appeared from the analysis of the second European trial of rtPA. The analysis also provided a hint of efficacy of abciximab. CONCLUSIONS: The responder analysis appears to be a potentially useful way to evaluate outcomes of patients enrolled in clinical trials in stroke. The results of the analysis have clinical relevance and can further explain differences in responses to therapies. In addition, the analysis allows for improved comparisons of results among clinical trials.

Acute Disease↗
PubMed2003

The Carotid Occlusion Surgery Study.

The St. Louis Carotid Occlusion Study demonstrated that ipsilateral increased O2 extraction fraction (OEF) (Stage II hemodynamic failure) measured by positron emission tomography (PET) is a powerful independent risk factor for subsequent stroke in patients with symptomatic complete carotid artery (CA) occlusion. The ipsilateral ischemic stroke rate at 2 years has been shown to be 5.3% in 42 patients with normal OEF and 26.5% in 39 patients with increased OEF (p = 0.004). In patients in whom hemispheric symptoms developed within 120 days, the 2-year ipsilateral stroke rates were 12% in 27 patients with normal OEF and 50% in 18 patients with increased OEF. Previous PET studies have demonstrated that anastomosis of the superficial temporal artery (STA) to a middle cerebral artery (MCA) cortical branch can restore OEF to normal. The authors discuss the undertaking of a study that will test the hypothesis that STA-MCA anastomosis, when combined with the best medical therapy, can reduce ipsilateral ischemic stroke by 40% at 2 years in patients with symptomatic internal CA occlusion and Stage II hemodynamic failure occurring within 120 days after surgery. Only patients with increased OEF distal to a symptomatic occluded CA will be randomized to surgery or medical treatment. The primary endpoint will be all strokes and death occurring between randomization and the 30-day postoperative cut off (with an equivalent period in the nonsurgical group), as well as subsequent ipsilateral ischemic stroke developing within 2 years. It is estimated that 186 patients will be required in each group. Assuming that 40% of PET scans will demonstrate increased OEF, this will require enrolling 930 clinically eligible individuals.

Anticoagulants↗
PubMed2003

Neurological aspects of biological and chemical terrorism: a review for neurologists.

The Centers for Disease Control and Prevention urge physicians to become familiar with chemical and biological weapons. Preparedness among neurologists is especially important because several of these agents affect the nervous system. This article reviews 4 agents that have a history of military or terrorist use: cyanide poisons, organophosphate poisons, botulinum toxin, and anthrax. Cyanide and organophosphate poisons are characterized by dose-dependent impairment of neurological function with nonspecific symptoms such as headache or dizziness at one end of the spectrum and convulsions and coma at the other. Neurological examinations help clinicians to differentiate these agents from other intoxications. Botulinum toxin has a delayed onset of action and results in descending paralysis and prominent cranial nerve palsies. Anthrax frequently causes fulminating hemorrhagic meningitis. Early recognition of these chemical and biological weapons is key to instituting specific therapy and preventing casualties within the health care team and the community at large.

Bioterrorism↗
PubMed2003

Early recovery after cerebral ischemia risk of subsequent neurological deterioration.

Given the high short-term risk of stroke after transient ischemic attack, we hypothesized that substantial acute neurological recovery in patients presenting with cerebral ischemia would be associated with a greater risk of subsequent neurological deterioration due to recurrent cerebral ischemia. Data from the Trial of ORG10172 in Acute Stroke Treatment, a randomized trial of the heparinoid danaparoid, were analyzed to determine whether substantial acute recovery, defined as an improvement of greater than or equal to 75% on National Institutes of Health Stroke Scale (NIHSS) between baseline and 24 hours, was associated with a greater risk of subsequent deterioration, defined as a worsening on the NIHSS between day 1 and day 90. Of 1,184 subjects meeting entry criteria, 63 (5.3%) had substantial acute recovery. Subsequent deterioration was more common in those with substantial acute recovery compared with others (48 vs 33%; p = 0.028 by Fisher's exact test). In multivariable models, substantial acute recovery remained an independent predictor of subsequent deterioration (odds ratio, 3.0; 95% confidence interval, 1.7-5.2; p < 0.001). Among patients with acute cerebral ischemia, those who recover substantially within 24 hours may be at greater risk of subsequent neurological deterioration due to causes other than hemorrhage.

Aged↗