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Abstract Background and Purpose The National Institutes of Health Stroke Scale NIHSS is a widely used measure of neurological function in clinical trials and patient assessment; inter-rater scoring variability could impact communications and trial power. The manner in which the rater certification test is scored yields multiple correct answers that have changed over time. We examined the range of possible total NIHSS scores from answers given in certification tests by over 7, individual raters who were certified. Methods We analyzed the results of all raters who completed one of two standard multiple-patient videotaped certification examinations between and The distribution of scores derived from those who passed the certification test then was examined.
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Results A total of 6, raters scored 5 patients on Test 1; 1, scored 6 patients on Test 2. Using a National Stroke Association NSA answer key, we found that correct total scores ranged from 2 correct scores to as many as 12 different correct total scores. Among raters who achieved a passing score and were therefore qualified to administer the NIHSS, score distributions were even wider, with 1 certification patient receiving 18 different correct total scores. Conclusions Allowing multiple acceptable answers for questions on the NIHSS certification test introduces scoring variability. It seems reasonable to assume that the wider the range of acceptable answers in the certification test, the greater the variability in the performance of the test in trials and clinical practice by certified examiners.
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The NIHSS is the culmination of a process that began with the need to develop a systematic means by which to clinically measure the severity of cerebral infarction in light of the introduction of new therapies for acute stroke. Previously limited clinical measurements and unvalidated rating scales were formalized in a scale developed at the University of Cincinnati Stroke Center as a system for examining patients with acute cerebral infarction [ 1 ]. Early versions of the scale, tested among stroke researchers on both live [ 1 , 3 ] and videotaped patients [ 4 ], all showed poor reliabilities for items intended to score facial movement, limb ataxia, and dysarthria, with moderate or excellent agreement on the remaining items. In , a videotaped training and certifying instrument was devised in order to systematically train investigators and coordinators of clinical trials to rate patients as consistently as possible on the NIHSS [ 6 ]. This is particularly important for multi-site clinical trials in which multiple investigators in different centers are measuring outcomes at variable times; inconsistency in the use of the scale might affect power and the ability to detect a true effect [ 3 , 4 , 5 ].
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This development of a required, uniform certification process, and the use of actual patients for scoring, has been an important step in helping clinical trials in stroke become more rigorous. Over time, however, the NIHSS certification process has been expanded; as greater numbers of institutions seek Joint Commission certified stroke center status, an increasing number of those seeking certification to administer the scale have little or no training in neurology, and include study personnel who have no formal medical training [ 6 , 7 ]. This group diverges appreciably from those for whom good test-retest reliability among various different raters was reported by Brott et al.
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It has become increasingly important, therefore, to determine whether the current training portion of the certification process adequately teaches all examiners, particularly those without prior training in stroke neurology or without medical training, to score patients comparably. In addition to extending beyond its originally intended administrators, the NIHSS has been utilized beyond its original and validated purpose into areas not currently supported by high-quality clinical evidence such as specifying clinical trial inclusion criteria [ 8 , 9 ], defining clinically important change from pre- to post-treatment [ 1 , 7 ], functioning as a primary [ 7 , 10 ] or secondary [ 8 , 11 , 12 , 13 , 14 , 15 , 16 ]endpoint in trials, determining differences between treatment groups in some studies [ 1 , 17 ], assessing stroke severity, and planning patient care by determining appropriate treatment for stroke patients [ 18 , 19 ].
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While the scale should not be used for purposes for which it has not been adequately validated, widespread documentation of such use places an even greater burden on the certification process. However, neurologic examination items, which previously have been found difficult for raters to score, continue to be problematic. Some of these, when viewed in a video image, are difficult to characterize despite multiple-angle presentations. To overcome the inherent limitations of video technology, the scoring algorithm for the certification test allows for multiple acceptable answers to many of the 15 individual items on which each patient is scored.
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Because the overall NIHSS score is a summation of the scores on these 15 individual stroke characteristics, items with multiple allowable scores necessarily impact the reliability of the total score. However, given the much wider use of the scale, this practice may well be detrimental to the teaching aspect that is key to the certification process. We aimed to determine whether the method for setting criteria for passing the certification tests contributes to an unacceptable level of scoring variability which could then be carried over into use of the scale in actual clinical practice. Such a finding could potentially lead to improvements to the training segment of the certification process that might increase scoring consistency of the NIHSS. Methods Analyses in this paper are based on the original VHS certification tapes, developed in While the current certification videos have changed, thousands of raters were certified using the original version, thus impacting research data for a number of years.
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These original tapes consisted of a min taped training program and two taped certification tests [ 20 ]. After watching the training tape, raters were asked to score 5 videotaped patients on Certification Tape 1. Six months later, each investigator was to review the training tape and score the 6 patients on Certification Tape 2. While a training module was provided, examiners were not required to complete it before attempting certification, and raters did not receive any immediate feedback on their performance, either during or after the test.
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Rater tests including fewer than five outliers on Test 1 or six outliers on Test 2 were considered passing; these raters were judged to be competent to administer the NIHSS during the trial. The two available certification videotapes included a total of 11 unique patients, with 15 items counting sub-items for each patient. A total NIHSS score could be calculated only for those patients for whom all 15 questions were answered; we included only those certification tests for which a complete score could be calculated for every patient included in the test.
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For raters who took the same test more than once, we included only their first test, whether or not they received a passing score on this test. This consisted of summing the answers for the 15 items pertaining to each patient, taking into account those items for which multiple answers were considered to be acceptable. We then scored rater certification tests to determine which raters had passed the test, and examined the distribution of individual NIHSS patient scores in this group of raters i. Results Our study included a total of 9, certification examinations completed over a 6-year period. Of these, 7, raters took Test 1 and 1, raters took Test 2. After excluding incomplete and repeat tests, 7, tests were eligible for these analyses: 6, unique raters each scoring 5 patients on Test 1 and 1, scoring 6 patients on Test 2.
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An unknown number of these users would have received training in using the scale, but this training was not required. In the best case, 1 patient had 2 acceptable total scores; in the most extreme case, a patient could be correctly assigned any of 12 different total scores. For this latter patient, as a result, any score between 24 and 35 would be considered correct by the established grading standards.
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Answers for the nihss certification group e And he looks in crime victims. The range for the correct score, calcu- lated using NIHSS 'correct answers', was determined for each. The National Institutes of Health Stroke Scale NIHSS is a widely used measure of neurological function in clinical trials and patient assessment; inter-rater scoring variability could impact communications and trial power. The manner in which the rater certification test is scored yields multiple correct answers that have changed over time. We examined the range of possible total NIHSS scores from answers given in certification tests by over 7, individual raters who were certified.
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Nihss Certification Test Answers Group E
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