Optimising outcome assessment to improve quality and efficiency of stroke trials

References

• Roger VL, Go AS, Lloyd-Jones DM et al.; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics 2012 update: a report from the American Heart Association. Circulation 3, 125(1), e2–e220 (2012).
   Google Scholar
• National Audit Office. Reducing Brain Damage: Faster Access to Better Stroke Care. National Audit Office. London, UK (2005).
   Google Scholar
• Dickson M, Gagnon JP. Key factors in the rising cost of new drug discovery and development. Nat. Rev. Drug Discov. 3(5), 417–429 (2004).
   PubMed Web of Science ®Google Scholar
• Saver JL. Optimal end points for acute stroke therapy trials: best ways to measure treatment effects of drugs and devices. Stroke 42(8), 2356–2362 (2011).
   PubMedGoogle Scholar
• Gresham GEM. Past achievements and new directions in stroke outcome research. Stroke 21(9), II1–II2 (1990).
   PubMedGoogle Scholar
• Basmajian JVM. The call for action. Stroke 21(9), II3 (1990).
   PubMedGoogle Scholar
• Anonymous. Symposium recommendations for methodology in Stroke Outcome Research: task force on stroke impairment, task force on stroke disability, and task force on stroke handicap. Stroke 21(9), II68–II73 (1990).
   PubMedGoogle Scholar
• Hewer RLP. Outcome measures in stroke: a British view. Stroke 21(9), II52–II55 (1990).
   PubMedGoogle Scholar
• Choi SC, Clifton GL, Marmarou A, Miller ER. Misclassification and treatment effect on primary outcome measures in clinical trials of severe neurotrauma. J. Neurotrauma 19(1), 17–22 (2002).
   PubMedGoogle Scholar
• Quinn TJ, Dawson J, Walters MR, Lees KR. Functional outcome measures in contemporary stroke trials. Int. J. Stroke 4(3), 200–205 (2009).
   PubMed Web of Science ®Google Scholar
• Brott T, Adams HP, Olinger CP et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke 20(7), 864–870 (1989).
   PubMed Web of Science ®Google Scholar
• Adams HP, Davis PH, Leira EC et al. Baseline NIH Stroke Scale score strongly predicts outcome after stroke. Neurology 53(1), 126 (1999).
   PubMed Web of Science ®Google Scholar
• Duffy L, Gajree S, Langhorne P, Stott DJ, Quinn TJ. Reliability (Inter-rater Agreement) of the barthel index for assessment of stroke survivors: systematic review and meta-analysis. Stroke 44(2), 462–468 (2013).
   PubMed Web of Science ®Google Scholar
• Kwon S, Hartzema AG, Duncan PW, Min-Lai S. Disability measures in stroke: relationship among the barthel index, the functional independence measure, and the modified Rankin Scale. Stroke 35(4), 918–923 (2004).
   PubMed Web of Science ®Google Scholar
• Duncan PW, Samsa GP, Weinberger M et al. Health status of individuals with mild stroke. Stroke 28(4), 740–745 (1997).
   PubMed Web of Science ®Google Scholar
• Quinn TJ, Langhorne P, Stott DJ. Barthel index for stroke trials: development, properties, and application. Stroke 42(4), 1146–1151 (2011).
   PubMed Web of Science ®Google Scholar
• Dromerick AW, Edwards DF, Diringer MN. Sensitivity to changes in disability after stroke: a comparison of four scales useful in clinical trials. J. Rehabil. Res. Dev. 40(1), 1–8 (2003).
   PubMedGoogle Scholar
• Rankin J. Cerebral vascular accidents in patients over the age of 60. II. Prognosis. Scot. Med. J. 2(5), 200–215 (1957).
   PubMedGoogle Scholar
• Langhorne P, Dennis M, Hankey G, Weir C, Williams B. Organised inpatient (stroke unit) care for stroke. Cochrane Database Syst. Rev. (4), CD000197 (2007).
   Google Scholar
• Farrell B, Godwin J, Richards S, Warlow C. The United Kingdom transient ischaemic attack (UK-TIA) aspirin trial: final results. J. Neurol. Neurosurg. Psychiat. 54(12), 1044–1054 (1991).
   PubMed Web of Science ®Google Scholar
• van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke 19(5), 604–607 (1988).
   PubMed Web of Science ®Google Scholar
• Huybrechts KF, Caro JJ, Xenakis JJ, Vemmos KN. The prognostic value of the modified Rankin Scale score for long-term survival after first-ever stroke. Results from the Athens Stroke Registry. Cerebrovasc. Dis. 26(4), 381–387 (2008).
   PubMedGoogle Scholar
• Dawson J, Lees JS, Chang TP et al. GAIN and VISTA Investigators. Association between disability measures and healthcare costs after initial treatment for acute stroke. Stroke 38(6), 1893–1898 (2007).
   PubMed Web of Science ®Google Scholar
• Ali M, Fulton R, Quinn T, Brady M. How well do standard stroke outcome measures reflect quality of life?: a retrospective analysis of clinical trial data. Stroke 44(11), 3161–3165 (2013).
   PubMedGoogle Scholar
• Banks JL, Marotta CA. Outcomes validity and reliability of the modified Rankin Scale: implications for stroke clinical trials: a literature review and synthesis. Stroke 38(3), 1091–1096 (2007).
   PubMed Web of Science ®Google Scholar
• Quinn TJ, Dawson J, Walters MR, Lees KR. Reliability of the modified Rankin Scale. Stroke 38(11), e144 (2007).
   Google Scholar
• Quinn TJ, Dawson J, Walters MR, Lees KR. Reliability of the modified Rankin Scale: a systematic review. Stroke 40(10), 3393–3395 (2009).
   PubMed Web of Science ®Google Scholar
• Wilson JTL, Hareendran A, Hendry A, Potter J, Bone I, Muir KW. Reliability of the modified Rankin Scale across multiple raters: benefits of a structured interview. Stroke 2005 36(4), 777–781.
   PubMed Web of Science ®Google Scholar
• Newcommon NJ, Green TL, Haley E, Cooke T, Hill MD. Improving the assessment of outcomes in stroke: use of a structured interview to assign grades on the modified Rankin Scale. Stroke 34(2), 377–378 (2003).
   PubMedGoogle Scholar
• Quinn TJ, Dawson J, Walters MR, Lees KR. Variability in modified rankin scoring across a large cohort of international observers. Stroke 39(11), 2975–2979 (2008).
   PubMed Web of Science ®Google Scholar
• Quinn TJ, Johnson PCD, Dawson J et al. Beneficial effect of improving modified Rankin Scale reliability on sample size for stroke trials. Cerebrovascular Diseases Conference: 19th European Stroke Conference. Barcelona, Spain, 25–28 May 2010.
   Google Scholar
• Edwards M, Feightner J, Goldsmith CH. Inter-rater reliability of assessments administered by individuals with and without a background in health care. Occup. Ther. J. Res. 15(2), 103–110 (1995).
   Google Scholar
• Nichols-Larsen DS, Clark PC, Zeringue A, Greenspan A, Blanton S. Factors influencing stroke survivors’ quality of life during subacute recovery. Stroke 36(7), 1480–1484 (2005).
   PubMed Web of Science ®Google Scholar
• New PW, Buchbinder R. Critical appraisal and review of the Rankin scale and its derivatives. Neuroepidemiology 26(1), 4–15 (2006).
   PubMed Web of Science ®Google Scholar
• Quinn TJ, Lees KR, Hardemark HG, Dawson J, Walters MR. Initial experience of a digital training resource for modified Rankin Scale assessment in clinical trials. Stroke 38(8), 2257–2261 (2007).
   PubMedGoogle Scholar
• Dennis M, Mead G, Doubal F, Graham C. Determining the modified rankin score after stroke by postal and telephone questionnaires. Stroke 43(3), 851–853 (2012).
   PubMedGoogle Scholar
• Wilson JT, Edwards P, Fiddes H, Stewart E, Teasdale GM. Reliability of postal questionnaires for the Glasgow Outcome Scale. J. Neurotrauma 19(9), 999–1005 (2002).
   PubMedGoogle Scholar
• Duncan PW, Reker DM, Horner RD et al. Performance of a mail-administered version of a stroke-specific outcome measure, the Stroke Impact Scale. Clin. Rehabil. 16(5), 493–505 (2002).
   PubMed Web of Science ®Google Scholar
• Korner-Bitensky N, Wood-Dauphinee S, Siemiatycki J, Shapiro S, Becker R. Health-related information postdischarge: telephone versus face-to-face interviewing. Arch. Phys. Med. Rehabil. 75(12), 1287–1296 (1994).
   PubMed Web of Science ®Google Scholar
• Heuschmann PU, Kolominsky-Rabas PL, Nolte CH et al. The reliability of the german version of the barthel-index and the development of a postal and telephone version for the application on stroke patients. [German] Abstract Only. Fortschr. Neurol. Psychiatr. 73(2), 74–82 (2005).
   PubMedGoogle Scholar
• Korner-Bitensky NP, Wood-Dauphinee SP. Barthel index information elicited over the telephone: is it reliable? Am. J. Phys. Med. Rehabil. 74(1), 9–18 (1995).
   PubMedGoogle Scholar
• Merino JG, Lattimore SU, Warach S. Telephone assessment of stroke outcome is reliable. Stroke 36(2), 232–233 (2005).
   PubMedGoogle Scholar
• Kasner SE, Chalela JA, Luciano JM et al. Reliability and validity of estimating the nih stroke scale score from medical records. Stroke 30(8), 1534–1537 (1999).
   PubMed Web of Science ®Google Scholar
• Quinn TJ, Ray G, Atula S, Walters MR, Dawson J, Lees KR. Deriving modified rankin scores from medical case-records. Stroke 39(12), 3421–3423 (2008).
   PubMed Web of Science ®Google Scholar
• McArthur KS, Beagan ML, Degnan A et al. Reliability and validity of proxy derived modified Rankin Scale assessment. Stroke Conference 2011 International Stroke Conference. Los Angeles, CA, USA, 9–11 February 2011.
   Google Scholar
• Knapp P, Hewison J. Disagreement in patient and carer assessment of functional abilities after stroke. Stroke 30(5), 934–938 (1999).
   PubMed Web of Science ®Google Scholar
• Williams LS, Bakas T, Brizendine E et al. How valid are family proxy assessments of stroke patients’ health-related quality of life? Stroke 37(8), 2081–2085 (2006).
   PubMed Web of Science ®Google Scholar
• Oczkowski C, O’Donnell M. Reliability of proxy respondents for patients with stroke: a systematic review. J. Stroke Cerebrovasc. Dis. 19(5), 410–416 (2009).
   Google Scholar
• Wilson JTL, Hareendran A, Grant M et al. Improving the assessment of outcomes in stroke: use of a structured interview to assign grades on the modified Rankin Scale. Stroke 33(9), 2243–2246 (2002).
   PubMed Web of Science ®Google Scholar
• Shinohara Y, Minematsu K, Amano T, Ohashi Y. Modified Rankin Scale with expanded guidance scheme and interview questionnaire: interrater agreement and reproducibility of assessment. Cerebrovasc. Dis. 21(4), 271–278 (2006).
   PubMedGoogle Scholar
• Cincura C, Pontes-Neto OM, Neville IS et al. Validation of the National Institutes of Health Stroke Scale, modified Rankin Scale and Barthel Index in Brazil: the role of cultural adaptation and structured interviewing. Cerebrovasc. Dis. 27(2), 119–122 (2009).
   PubMed Web of Science ®Google Scholar
• Patel NB, Rao VAM, Heilman-Espinoza ERM, Lai RD, Quesada RAM, Flint ACM. Simple and reliable determination of the modified Rankin Scale score in neurosurgical and neurological patients: the mRS-9Q. Neurosurgery 71(5), 971–975 (2012).
   PubMedGoogle Scholar
• Wolfe CD, Taub NA, Woodrow EJ, Burney PG. Assessment of scales of disability and handicap for stroke patients. Stroke 22(10), 1242–1244 (1991).
   PubMed Web of Science ®Google Scholar
• Newcommon NJ, Green TL, Haley E, Cooke T, Hill MD. Improving the assessment of outcomes in stroke: use of a structured interview to assign grades on the modified Rankin Scale. Stroke 34(2), 377–378 (2003).
   PubMedGoogle Scholar
• Saver JL, Filip B, Hamilton S et al.; FAST-MAG Investigators and Coordinators. Improving the reliability of stroke disability grading in clinical trials and clinical practice: the rankin focused assessment (RFA). Stroke 41(5), 992–995 (2010).
   PubMed Web of Science ®Google Scholar
• Celani MG, Cantisani TA, Righetti E, Spizzichino L, Ricci S. Different measures for assessing stroke outcome: an analysis from the international stroke trial in Italy. Stroke 33(1), 218–223 (2002).
   PubMedGoogle Scholar
• Bruno A, Shah N, Lin C et al. Improving modified Rankin Scale assessment with a simplified questionnaire. Stroke 41(5), 1048–1050 (2010).
   PubMed Web of Science ®Google Scholar
• Bruno A, Close B, Switzer JA et al. Simplified modified Rankin Scale questionnaire correlates with stroke severity. Clin. Rehabil. 27(8), 724–727 (2013).
   PubMedGoogle Scholar
• Bruno A, Shah N, Akinwuntan AE, Close B, Switzer JA. Stroke size correlates with functional outcome on the simplified modified Rankin Scale questionnaire. J. Stroke Cerebrovasc. Dis. 22(6), 781–783 (2013).
   PubMedGoogle Scholar
• Bruno A, Akinwuntan AE, Lin C et al. Simplified modified Rankin Scale questionnaire: reproducibility over the telephone and validation with quality of life. Stroke 42(8), 2276–2279 (2011).
   PubMedGoogle Scholar
• Yuan JL, Bruno A, Li T et al. Replication and extension of the simplified modified Rankin Scale in 150 Chinese stroke patients. Eur. Neurol. 67(4), 206–210 (2012).
   PubMed Web of Science ®Google Scholar
• Juttler E, Schwab S, Schmiedek P et al. DESTINY Study Group. Decompressive Surgery for the treatment of malignant infarction of the middle cerebral artery (DESTINY): a randomized, controlled trial. Stroke 38(9), 2518–2525 (2007).
   PubMed Web of Science ®Google Scholar
• Muir KW, Lees KR, Ford I, Davis S, Intravenous magnesium efficacy in stroke (IMAGES) study Investigators. Magnesium for acute stroke (Intravenous Magnesium Efficacy in Stroke trial): randomised controlled trial. Lancet 363(9407), 439–445 (2004).
   PubMed Web of Science ®Google Scholar
• The International Stroke Trial (IST): a randomised trial of aspirin, subcutaneous heparin, both, or neither among 19435 patients with acute ischaemic stroke. International Stroke Trial Collaborative Group. Lancet 349(9065), 1569–1581 (1997).
   PubMedGoogle Scholar
• He S, Wu S, Zeng Q et al. Assessment of methodological quality and outcome measures of acute stroke randomized controlled trials in China in recent 15 years. J. Evid. Based Med. 5(3), 174–182 (2012).
   PubMedGoogle Scholar
• Liu M, Wu B, Wang WZ, Lee LM, Zhang SH, Kong LZ. Stroke in China: epidemiology, prevention, and management strategies. Lancet Neurol. 6(5), 456–464 (2007).
   PubMed Web of Science ®Google Scholar
• Liu M, Wu B, Yuan Q. Methods of outcome assessment in chinese acute stroke trials. Chinese J. Evid. Based Med. 4, 164–166 (2004).
   Google Scholar
• McArthur KS, Johnson PCD, Quinn TJ et al. Improving the efficiency of stroke trials: feasibility and efficacy of group adjudication of functional end points. Stroke 44(12), 3422–3428 (2013).
   PubMedGoogle Scholar
• Berge E, Barer D. Could stroke trials be missing important treatment effects?. Cerebrovasc. Dis. 13(1), 73–75 (2002).
   PubMedGoogle Scholar
• Shuaib A, Lees KR, Lyden P et al. NXY-059 for the treatment of acute ischemic stroke. N. Engl. J. Med. 357(6), 562–571 (2007).
   PubMed Web of Science ®Google Scholar
• Lees KR, Asplund K, Carolei A et al. Glycine antagonist (gavestinel) in neuroprotection (GAIN International) in patients with acute stroke: a randomised controlled trial. GAIN International Investigators. Lancet 355(9219), 1949–1954 (2000).
   PubMed Web of Science ®Google Scholar
• Tilley BC, Marler J, Geller NL et al. Use of a global test for multiple outcomes in stroke trials with application to the National Institute of Neurological Disorders and Stroke t-PA Stroke Trial. Stroke 27(11), 2136–2142 (1996).
   PubMed Web of Science ®Google Scholar
• Tissue plasminogen activator for acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. N. Engl. J. Med. 333(24), 1581–1587 (1995).
   PubMed Web of Science ®Google Scholar
• Lees R, Fearon P, Harrison JK, Broomfield NM, Quinn TJ. Cognitive and mood assessment in stroke research: focused review of contemporary studies. Stroke 43(6), 1678–1680 (2012).
   PubMed Web of Science ®Google Scholar