Abstract
Consensus on appropriate outcome measures to use in aneurysmal subarachnoid hemorrhage (aSAH) research has not been established, although the transition toward a core outcome set (COS) would provide significant benefits. To inform COS development, we conducted a systematic review to identify outcome measures included in reports of randomized clinical trials (RCTs) of interventions in patients with aSAH. Ovid Medline, EMBASE, CINAHL, and CENTRAL were searched. RCTs investigating aSAH published between January 1996 and May 2015 were included. The primary and secondary outcomes of RCTs were recorded and classified according to the OMERACT Consortium’s framework. We identified 1093 potential studies of which 129 met inclusion criteria representing 24 238 patients. There were 285 unique outcome measures. The Glasgow Outcome Scale (GOS) was the most frequently used primary outcome (13/129, 10.1%). Mortality was reported in 84 trials (65.1%) with 3 months the most common time point (34/129, 26.4%). The GOS (65/129, 50.4%) and the Modified Rankin Scale (51/129, 39.5%) were the most commonly reported functional measures; however, these were reported at different time points and often dichotomized using different ranges. Patient-reported quality of life measures were used in 11 trials (8.5%). Transcranial Doppler was the most frequently used imaging modality (40/129, 31.0%). Definitions and reporting of vasospasm, delayed cerebral ischemia and imaging modality results were highly variable. The marked heterogeneity of outcomes in reports of RCTs supports the development of a core outcome set for aSAH trials. Our study has identified a wide range of outcomes for potential inclusion in a future aSAH COS.
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References
Lai L, Morgan MK. Incidence of subarachnoid haemorrhage: an Australian national hospital morbidity database analysis. J Clin Neurosci. 2012;19:733–9.
de Rooij NK, Linn FH, van der Plas JA, Algra A, Rinkel GJ. Incidence of subarachnoid haemorrhage: a systematic review with emphasis on region, age, gender and time trends. J Neurol Neurosurg Psychiatry. 2007;78:1365–72.
Schweizer TA, Macdonald RL. Brain hemorrhage: assessing outcome after subarachnoid hemorrhage. Nat Rev Neurol. 2010;6:427–8.
Suarez JI, Tarr RW, Selman WR. Aneurysmal subarachnoid hemorrhage. N Engl J Med. 2006;354:387–96.
Nieuwkamp DJ, Setz LE, Algra A, Linn FH, de Rooij NK, Rinkel GJ. Changes in case fatality of aneurysmal subarachnoid haemorrhage over time, according to age, sex, and region: a meta-analysis. Lancet Neurol. 2009;8:635–42.
Connolly ES Jr, Rabinstein AA, Carhuapoma JR, et al. Guidelines for the management of aneurysmal subarachnoid hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2012;43:1711–37.
Vergouwen MD, Vermeulen M, van Gijn J, et al. Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group. Stroke. 2010;41:2391–5.
Baharoglu MI, Germans MR, Rinkel GJ, et al. Antifibrinolytic therapy for aneurysmal subarachnoid haemorrhage. Cochrane Database Syst Rev. 2013. https://doi.org/10.1002/14651858.CD001245.pub2.
Sheehan J, Hirschfeld S, Foster E, et al. Improving the value of clinical research through the use of Common Data Elements. Clin Trials. 2016;13:671–6.
Williamson P, Altman D, Blazeby J, Clarke M, Gargon E. Driving up the quality and relevance of research through the use of agreed core outcomes. J Health Serv Res Policy. 2012;17:1–2.
Koroshetz W. A core set of trial outcomes for every medical discipline? BMJ. 2015;350:h85.
Gargon E, Gurung B, Medley N, et al. Choosing important health outcomes for comparative effectiveness research: a systematic review. PLoS ONE. 2014;9:e99111.
Tugwell P, Boers M, Brooks P, Simon L, Strand V, Idzerda L. OMERACT: an international initiative to improve outcome measurement in rheumatology. Trials. 2007;8:38.
Williamson PR, Altman DG, Blazeby JM, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13:132.
Boers M, Kirwan JR, Wells G, et al. Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. J Clin Epidemiol. 2014;67:745–53.
Moher D, Liberati A, Tetzlaff J, Altman DG, Group P. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6:e1000097.
Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276:637–9.
Thomas JBJ, Graziosi S. EPPI-Reviewer 4: software for research synthesis. London: Social Science Research Unit, UCL Institute of Education; 2010.
Nimmo WS, Tucker GT. Clinical measurement in drug evaluation. New York: Wiley; 1995.
Jennett B, Bond M. Assessment of outcome after severe brain damage. Lancet. 1975;1:480–4.
Rankin J. Cerebral vascular accidents in patients over the age of 60. I. General considerations. Scott Med J. 1957;2:127–36.
van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988;19:604–7.
Brott T, Adams HP Jr, Olinger CP, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989;20:864–70.
Wade DT, Collin C. The Barthel ADL Index: a standard measure of physical disability? Int Disabil Stud. 1988;10:64–7.
Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998;15:573–85.
Karnofsky DA, Abelmann WH, Craver LF, Burchenal JH. The use of the nitrogen mustards in the palliative treatment of carcinoma. With particular reference to bronchogenic carcinoma. Cancer. 1948;1:634–56.
Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. 1974;2:81–4.
Teasdale GM, Drake CG, Hunt W, et al. A universal subarachnoid hemorrhage scale: report of a committee of the World Federation of Neurosurgical Societies. J Neurol Neurosurg Psychiatry. 1988;51:1457.
Dikmen S, Machamer J, Miller B, Doctor J, Temkin N. Functional status examination: a new instrument for assessing outcome in traumatic brain injury. J Neurotrauma. 2001;18:127–40.
Holman R, Lindeboom R, Glas CAW, Vermeulen M, de Haan RJ. Constructing an item bank using item response theory: the AMC linear disability score project. Health Serv Outcomes Res Methodol. 2003;4:19–33.
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–83.
EuroQol G. EuroQol–a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199–208.
Bergner M, Bobbitt RA, Carter WB, Gilson BS. The sickness impact profile: development and final revision of a health status measure. Med Care. 1981;19:787–805.
Brass LM. Trial design issues: endpoints and sample size. Cerebrovasc Dis. 1995;5:3–11.
Sintonen H. The 15D instrument of health-related quality of life: properties and applications. Ann Med. 2001;33:328–36.
Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999;282:1737–44.
Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Personal Assess. 1985;49:71–5.
Wechsler D. Wechsler adult intelligence scale. New York: The Psychological Corporation; 1955.
Wechsler D. Wechsler memory scale-revised manual. New York: The Psychological Corporation; 1987.
Armitage SG. An analysis of certain psychological tests used for the evaluation of brain injury. Psychol Monogr. 1946;60:1–48.
Lindegaard KF, Nornes H, Bakke SJ, Sorteberg W, Nakstad P. Cerebral vasospasm diagnosis by means of angiography and blood velocity measurements. Acta Neurochir (Wien). 1989;100:12–24.
Duncan PW, Jorgensen HS, Wade DT. Outcome measures in acute stroke trials: a systematic review and some recommendations to improve practice. Stroke. 2000;31:1429–38.
Unruptured cerebral aneurysms and subarachnoid hemorrhage CDE highlight summary. 2017. https://www.commondataelements.ninds.nih.gov/Doc/SAH/SAH_CDE_Highlight_Summary.pdf. Accessed 16 Jun 2017.
Salinas J, Sprinkhuizen SM, Ackerson T, et al. An international standard set of patient-centered outcome measures after stroke. Stroke. 2016;47:180–6.
Al-Tamimi YZ, Bhargava D, Feltbower RG, et al. Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage: a prospective, randomized, controlled trial (LUMAS). Stroke. 2012;43:677–82.
Etminan N, Beseoglu K, Eicker SO, Turowski B, Steiger HJ, Hanggi D. Prospective, randomized, open-label phase II trial on concomitant intraventricular fibrinolysis and low-frequency rotation after severe subarachnoid hemorrhage. Stroke. 2013;44:2162–8.
Rasmussen R, Juhler M, Wetterslev J. Effects of continuous prostacyclin infusion on regional blood flow and cerebral vasospasm following subarachnoid haemorrhage: statistical analysis plan for a randomized controlled trial. Trials. 2014;15:228.
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Christopher R. Andersen designed the analysis, completed the data extraction, and wrote the manuscript. Emily Fitzgerald completed the data extraction. Simon Finfer and Anthony Delaney advised and assisted in the analysis of the design and revised and assisted in the completion of the manuscript.
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Andersen, C.R., Fitzgerald, E., Delaney, A. et al. A Systematic Review of Outcome Measures Employed in Aneurysmal Subarachnoid Hemorrhage (aSAH) Clinical Research. Neurocrit Care 30, 534–541 (2019). https://doi.org/10.1007/s12028-018-0566-0
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DOI: https://doi.org/10.1007/s12028-018-0566-0