National Institutes of Health Stroke Scale: An Alternative Primary Outcome Measure for Trials of Acute Treatment for Ischemic Stroke
| Autor: | Chalos, Vicky, van der Ende, Nadinda A. M., Lingsma, Hester F., Mulder, Maxim J. H. L., Venema, Esmee, Dijkland, Simone A., Berkhemer, Olvert A., Yoo, Albert J., Broderick, Joseph P., Palesch, Yuko Y., Yeatts, Sharon D., Roos, Yvo B. W. E. M., van Oostenbrugge, Robert J., van Zwam, Wim H., Majoie, Charles B. L. M., van der Lugt, Aad, Roozenbeek, Bob, Dippel, Diederik W. J., Fransen, Puck S. S., Beumer, Debbie, van den Berg, Lucie A., Schonewille, Wouter J., Vos, Jan Albert, Nederkoorn, Paul J., Wermer, Marieke J. H., van Walderveen, Marianne A. A., Staals, Julie, Hofmeijer, Jeannette, van Oostayen, Jacques A., Nijeholt, Geert J. Lycklama A., Boiten, Jelis, Brouwer, Patrick A., Emmer, Bart J., de Bruijn, Sebastiaan F., van Dijk, Lukas C., Kappelle, L. Jaap, Lo, Rob H., van Dijk, Ewoud J., de Vries, Joost, de Kort, Paul L. M., van Rooij, Willem Jan J., van den Berg, Jan S. P., van Hasselt, Boudewijn A. A. M., Aerden, Leo A. M., Dallinga, Rene J., Visser, Marieke C., Bot, Joseph C. J., Vroomen, Patrick C., Eshghi, Omid, Schreuder, Tobien H. C. M. L., Heijboer, Roel J. J., Keizer, Koos, Tielbeek, Alexander V., den Hertog, Heleen M., Gerrits, Dick G., van den Berg-Vos, Renske M., Karas, Giorgos B., Steyerberg, Ewout W., Flach, H. Zwenneke, Marquering, Henk A., Sprengers, Marieke E. S., Jenniskens, Sjoerd F. M., Beenen, Ludo F. M., van den Berg, Rene, Koudstaal, Peter J. |
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| Přispěvatelé: | Radiology and nuclear medicine, VU University medical center, Neurology, Amsterdam Neuroscience - Neurovascular Disorders, ACS - Atherosclerosis & ischemic syndromes, Public Health, Radiology & Nuclear Medicine, Radiology and Nuclear Medicine, ANS - Neurovascular Disorders, ACS - Microcirculation, ACS - Amsterdam Cardiovascular Sciences, Graduate School, ACS - Pulmonary hypertension & thrombosis, AGEM - Digestive immunity, AGEM - Re-generation and cancer of the digestive system, ARD - Amsterdam Reproduction and Development, MUMC+: MA Neurologie (3), Klinische Neurowetenschappen, MUMC+: Hersen en Zenuw Centrum (3), RS: Carim - B05 Cerebral small vessel disease, Beeldvorming, MUMC+: DA BV Medisch Specialisten Radiologie (9), RS: Carim - B06 Imaging, MUMC+: MA AIOS Neurologie (9), MUMC+: MA Med Staf Spec Neurologie (9) |
| Rok vydání: | 2020 |
| Předmět: |
Male
endovascular treatment Original Contributions 030204 cardiovascular system & hematology law.invention Brain Ischemia 0302 clinical medicine Randomized controlled trial Modified Rankin Scale Informed consent law Stroke Netherlands Confounding Endovascular Procedures informed consent Middle Aged Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3] stroke 3. Good health thrombectomy ComputingMethodologies_DOCUMENTANDTEXTPROCESSING outcome Female Cardiology and Cardiovascular Medicine SURROGATE END-POINTS CLINICAL-TRIALS medicine.medical_specialty Mechanical Thrombolysis ENDOVASCULAR THERAPY Clinical Sciences 03 medical and health sciences ALTEPLASE Internal medicine medicine Humans cardiovascular diseases PLASMINOGEN-ACTIVATOR Aged Advanced and Specialized Nursing Surrogate endpoint business.industry Other Research Radboud Institute for Health Sciences [Radboudumc 0] Odds ratio medicine.disease United States RANDOMIZED-TRIAL Clinical trial SEVERITY National Institutes of Health (U.S.) Neurology (clinical) business 030217 neurology & neurosurgery Follow-Up Studies NIHSS |
| Zdroj: | Stroke, 51, 282-290 Stroke, 51(1), 282-290. Lippincott Williams and Wilkins Stroke, 51(1), 282-290. Lippincott Williams & Wilkins Stroke Stroke; a journal of cerebral circulation, 51(1), 282-290. Lippincott Williams and Wilkins Stroke, 51(1), 282-290. LIPPINCOTT WILLIAMS & WILKINS Stroke, 51, 1, pp. 282-290 Stroke, 51(1), 282-290. Lippincott, Williams & Wilkins Chalos, V, van der Ende, N A M, Lingsma, H F, Mulder, M J H L, Venema, E, Dijkland, S A, Berkhemer, O A, Yoo, A J, Broderick, J P, Palesch, Y Y, Yeatts, S D, Roos, Y B W E M, van Oostenbrugge, R J, van Zwam, W H, Majoie, C B L M, van der Lugt, A, Roozenbeek, B, Dippel, D W J, Berkhemer, O A, Fransen, P S S, Beumer, D, van den Berg, L A, Lingsma, H F, Yoo, A J, Schonewille, W J, Vos, J A, Nederkoorn, P J, Wermer, M J H, van Walderveen, M A A, Staals, J, Hofmeijer, J, van Oostayen, J A, Nijeholt, G J L A, Boiten, J, Brouwer, P A, Emmer, B J, de Bruijn, S F, van Dijk, L C, Kappelle, L J, Lo, R H, van Dijk, E J, de Vries, J, de Kort, P L M, van Rooij, W J J, van den Berg, J S P, van Hasselt, B A A M, Aerden, L A M, Dallinga, R J, Visser, M C, Bot, J C J, Vroomen, P C, Eshghi, O, Schreuder, T H C M L, Heijboer, R J J, Keizer, K, Tielbeek, A V, den Hertog, H M, Gerrits, D G, van den Berg-Vos, R M, Karas, G B, Steyerberg, E W, Flach, H Z, Marquering, H A, Sprengers, M E S, Jenniskens, S F M, Beenen, L F M, van den Berg, R & Koudstaal, P J 2020, ' National Institutes of Health Stroke Scale An Alternative Primary Outcome Measure for Trials of Acute Treatment for Ischemic Stroke ', Stroke, vol. 51, no. 1, pp. 282-290 . https://doi.org/10.1161/STROKEAHA.119.026791 |
| ISSN: | 0039-2499 |
| DOI: | 10.1161/STROKEAHA.119.026791 |
| Popis: | Supplemental Digital Content is available in the text. Background and Purpose— The modified Rankin Scale (mRS) at 3 months is the most commonly used primary outcome measure in stroke treatment trials, but it lacks specificity and requires long-term follow-up interviews, which consume time and resources. An alternative may be the National Institutes of Health Stroke Scale (NIHSS), early after stroke. Our aim was to evaluate whether the NIHSS assessed within 1 week after treatment could serve as a primary outcome measure for trials of acute treatment for ischemic stroke. Methods— We used data from 2 randomized controlled trials of endovascular treatment for ischemic stroke: the positive MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands; N=500) and the neutral IMS (Interventional Management of Stroke) III trial (N=656). We used a causal mediation model, with linear and ordinal logistic regression adjusted for confounders, to evaluate the NIHSS 24 hours and 5 to 7 days after endovascular treatment as primary outcome measures (instead of the mRS at 3 months) in both trials. Patients who had died before the NIHSS was assessed received the maximum score of 42. NIHSS+1 was then log10-transformed. Results— In both trials, there was a significant correlation between the NIHSS at 24 hours and 5 to 7 days and the mRS. In MR CLEAN, we found a significant effect of endovascular treatment on the mRS and on the NIHSS at 24 hours and 5 to 7 days. After adjustment for NIHSS at 24 hours and 5 to 7 days, the effect of endovascular treatment on the mRS decreased from common odds ratio 1.68 (95% CI, 1.22–2.32) to respectively 1.36 (95% CI, 0.97–1.91) and 1.24 (95% CI, 0.87–1.79), indicating that treatment effect on the mRS is in large part mediated by the NIHSS. In the IMS III trial there was no treatment effect on the NIHSS at 24 hours and 5 to 7 days, corresponding with the absence of a treatment effect on the mRS. Conclusions— The NIHSS within 1 week satisfies the requirements for a surrogate end point and may be used as a primary outcome measure in trials of acute treatment for ischemic stroke, particularly in phase II(b) trials. This could reduce stroke-outcome assessment to its essentials (ie, neurological deficit), and reduce trial duration and costs. Whether and under which conditions it could be used in phase III trials requires a debate in the field with all parties. Clinical Trial Registration— URL: http://www.isrctn.com. Unique identifier: ISRCTN10888758; https://www.clinicaltrials.gov. Unique identifier: NCT00359424. |
| Databáze: | OpenAIRE |
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