ALS Multicenter Cohort Study of Oxidative Stress (ALS COSMOS): Study methodology, recruitment, and baseline demographic and disease characteristics

References

• D’Amico E, Factor-Litvak P, Santella RM, Mitsumoto H. Clinical perspective of oxidative stress in sproradic ALS. Free Rad Biol Med. 2013;65:50927.
   Web of Science ®Google Scholar
• Andersen JK. Oxidative stress in neurodegeneration: cause or consequence?. Nature Medicine. 2004;10 (Suppl):S18–25.
   PubMed Web of Science ®Google Scholar
• Beckman JS, Estevez AG. Superoxide dismutase, oxidative stress, and ALS. In: Mitsumoto H, Perzedborski S, Gordon PH, editors. Amyotrophic Lateral Sclerosis. New York: Taylor and Francis; 2005. pp 339–54.
   Google Scholar
• Shaw PJ. Molecular and cellular pathways of neurodegeneration in motor neuron disease. J Neurol Neurosurg Psychiatry. 2005;76:1046–57.
   PubMed Web of Science ®Google Scholar
• Martin LJ, Liu Z, Chen K, Price AC, Pan Y, Swaby JA, et al. Motor neuron degeneration in amyotrophic lateral sclerosis mutant superoxide dismutase-1 transgenic mice: mechanisms of mitochondriopathy and cell death. J Comp Neurol. 2007;500:20–46.
   PubMed Web of Science ®Google Scholar
• Pasinelli P, Brown RH. Molecular biology of amyotrophic lateral sclerosis: insights from genetics. Nat Rev Neurosci. 2006;7:710–23.
   PubMed Web of Science ®Google Scholar
• Kaufmann P, Thompson JL, Levy G, Buchsbaum R, Shefner J, Krivickas LS, et al. Phase II trial of CoQ10 for ALS finds insufficient evidence to justify phase III. Annals of Neurology. 2009;66:235–44.
   PubMed Web of Science ®Google Scholar
• Gwinn K, Corriveau RA, Mitsumoto H, Bednarz K, Brown RH Jr, Cudkowicz M, et al. Amyotrophic Lateral Sclerosis: An Emerging Era of Collaborative Gene Discovery. PloSONE. 2007;2:e1234.
   Web of Science ®Google Scholar
• World Federation NRGoAS. A revised El Escorial World Federation of Neurology criteria for the diagnosis of amyotrophic lateral sclerosis. 2000; [cited 2013 July 3]. Available from: www.wfnals.org.
   Google Scholar
• de Carvalho M, Dengler R, Eisen A, England JD, Kaji R, Kimura J, et al. Electrodiagnostic criteria for diagnosis of ALS. J Clinical Neurophysiol. 2008;3:493–503.
   Google Scholar
• Cedarbaum J. ALS endpoints. Survival. Amyotroph Lateral Scler Other Motor Neuron Disord. 2004;5 (Suppl 1): 79–83.
   PubMedGoogle Scholar
• Gordon PH, Miller RG, Moore DH. ALSFRS-R. Amyotroph Lateral Scler Other Motor Neuron Disord. 2004; 5 (Suppl 1):90–3.
   PubMed Web of Science ®Google Scholar
• Gordon PH, Moore DH, Miller RG, Florence JM, Verheijde JL, Doorish C, et al. Efficacy of minocycline in patients with amyotrophic lateral sclerosis: a phase III randomized trial. Lancet Neurol. 2007;6:1045–53.
   PubMed Web of Science ®Google Scholar
• Miller R, Bradley W, Cudkowicz M, Hubble J, Meininger V, Mitsumoto H, et al. Phase II/III randomized trial of TCH346 in patients with ALS. Neurology. 2007;69:776–84.
   PubMed Web of Science ®Google Scholar
• Traynor BJ, Zhang H, Shefner JM, Schoenfeld D, Cudkowicz ME. Functional outcome measures as clinical trial endpoints in ALS. Neurology. 2004;63:1933–5.
   PubMed Web of Science ®Google Scholar
• Woolley SC, York MK, Moore DH, Strutt AM, Murphy J, Schulz PE, et al. Detecting frontotemporal dysfunction in ALS: utility of the ALS Cognitive Behavioral Screen (ALS-CBS™). Amyotroph Lateral Scler. 2010; 11:303–11.
   PubMed Web of Science ®Google Scholar
• Rippon GA, Scarmeas N, Gordon PH, Murphy PL, Albert SM, Mitsumoto H, et al. An observational study of cognitive impairment in amyotrophic lateral sclerosis. Arch Neurol-Chicago. 2006;63:345–52.
   PubMed Web of Science ®Google Scholar
• Mitsumoto H, Santella RM, Liu X, Bogdanov M, Zipprich J, Wu HC, et al. Oxidative stress biomarkers in sporadic ALS. Amyotrophic lateral sclerosis: official publication of the World Federation of NeurologyResearch Group on Motor Neuron Diseases. 2008;9:177–83.
   Google Scholar
• Dupuis L, Corcia P, Fergani A, de Aguilar JLG, Bonnefont-Rousselot D, Bittar R, et al. Dyslipidemia is a protective factor in amyotrophic lateral sclerosis. Neurology. 2008;70:1004–9.
   PubMed Web of Science ®Google Scholar
• Sutedja NA, van der Schouw YT, Fischer K, Sizoo EM, Huisman MHB, Veldink JH, et al. Beneficial vascular risk profile is associated with amyotrophic lateral sclerosis. J Neurol Neurosur Ps. 2011;82:638–42.
   PubMed Web of Science ®Google Scholar
• Block G, Hartman AM, Naughton D. A reduced dietary questionnaire: development and validation. Epidemiology. 1990;1:58–64.
   PubMedGoogle Scholar
• Cummings SR, Block G, McHenry K, Baron RB. Evaluation of two food frequency methods of measuring dietary calcium intake. Am J Epidemiol. 1987;126:796–802.
   PubMed Web of Science ®Google Scholar
• Nieves JW, Golden AL, Siris E, Kelsey JL, Lindsay R. Teenage and current calcium intake are related to bone mineral density of the hip and forearm in females aged 30–39 years. Am J Epidemiol. 1995;141:342–51.
   PubMed Web of Science ®Google Scholar
• Serdula M, Coates R, Byers T, Mokdad A, Jewell S, Chavez N, et al. Evaluation of a brief telephone questionnaire to estimate fruit and vegetable consumption in diverse study populations. Epidemiology. 1993;4:455–63.
   PubMed Web of Science ®Google Scholar
• NutritionQuest. 2011. [cited 2013 October 27]. Available from: https://www.nutritionquest.com/
   Google Scholar
• Epel ES, Blackburn EH, Lin J, Dhabhar FS, Adler NE, Morrow JD, et al. Accelerated telomere shortening in response to life stress. Proc Natl Acad Sci U S A. 2004; 101:17312–5.
   PubMed Web of Science ®Google Scholar
• Epel ES, Lin J, Wilhelm FH, Wolkowitz OM, Cawthon R, Adler NE, et al. Cell aging in relation to stress arousal and cardiovascular disease risk factors. Psychoneuroendocrinology. 2006;31:277–87.
   PubMed Web of Science ®Google Scholar
• Sapolsky RM. Organismal stress and telomeric aging: an unexpected connection. Proc Natl Acad Sci U S A. 2004; 101:17323–4.
   PubMed Web of Science ®Google Scholar
• Albert SM, Rabkin JG, del Bene ML, Tider T, O’Sullivan I, Rowland LP, et al. Wish to die in end-stage ALS. Neurology. 2005;65:68–74.
   PubMed Web of Science ®Google Scholar
• Rabkin JG, Wagner GJ, del Bene M. Resilience and distress among amyotrophic lateral sclerosis patients and caregivers. Psychosom Med. 2000;62:271–9.
   PubMed Web of Science ®Google Scholar
• Rabkin JG, Albert SM, del Bene ML, O’Sullivan I, Tider T, Rowland LP, et al. Prevalence of depressive disorders and change over time in late-stage ALS. Neurology. 2005;65:62–7.
   PubMed Web of Science ®Google Scholar
• Lee JR, Annegers JF, Appel SH. Prognosis of amyotrophic lateral sclerosis and the effect of referral selection. J Neurol Sci. 1995;132:207–15.
   PubMed Web of Science ®Google Scholar
• Logroscino G, Traynor BJ, Hardiman O, Chio A, Couratier P, Mitchell JD, et al. Descriptive epidemiology of amyotrophic lateral sclerosis: new evidence and unsolved issues. Journal of Neurology, Neurosurgery, and Psychiatry. 2008;79:6–11.
   PubMed Web of Science ®Google Scholar
• Chad D, Rowland L, Armon C, Bedlack R, Durham H, Factor-Litvak P. Peer Recommendations 5on How to Improve Clinical Research and Final Conference Wrap-up. Amyotroph Lateral Scler Frontotemporal Degener. 2013; 14(Suppl 1):67–73.
   PubMedGoogle Scholar
• Factor-Litvak P, Al-Chalabi A, Asherio A, Bradley W, Chío A, Garruto R, et al. Current Pathways for Epidemiological Research in Amyotrophic Lateral Sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2013;14(Suppl 1):33–43.
   PubMed Web of Science ®Google Scholar
• Sherman A, Gubitz A, Al-Chalabi A, Bedlack R, Berry J, Conwit R. Infrastructure Resources for Clinical Research in Amyotrophic Lateral Sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2013;14(Suppl 1):53–61.
   PubMedGoogle Scholar
• Bedlack RS, Pastula DM, Welsh E, Pulley D, Cudkowicz ME. Scrutinizing enrollment in ALS clinical trials: room for improvement? Amyotrophic Lateral Sclerosis: official publication of the World Federation of Neurology Research Group on Motor Neuron Diseases. 2008;9:257–65.
   Google Scholar
• Bedlack RS, Wicks P, Heywood J, Kasarskis E. Modifiable barriers to enrollment in American ALS research studies. Amyotrophic lateral sclerosis : official publication of the World Federation of Neurology Research Group on MotorNeuron Diseases. 2010;11:502–7.
   Google Scholar
• Moser DJ, Schultz SK, Arndt S, Benjamin ML, Fleming FW, Brems CS, et al. Capacity to provide informed consent for participation in schizophrenia and HIV research. Am J Psychiatry. 2002;159:1201–7.
   PubMed Web of Science ®Google Scholar
• Abrahams S, Leigh PN, Harvey A, Vythelingum GN, Grise D, Goldstein LH. Verbal fluency and executive dysfunction in amyotrophic lateral sclerosis (ALS). Neuropsychologia. 2000;38:734–47.
   PubMed Web of Science ®Google Scholar
• Kertesz A, Nadkarni N, Davidson W, Thomas AW. The Frontal Behavioral Inventory in the differential diagnosis of frontotemporal dementia. J Int Neuropsychol Soc. 2000;6: 460–8.
   PubMed Web of Science ®Google Scholar
• Smith RA, Berg JE, Pope LE, Thisted RA. Measuring pseudobulbar affect in ALS. Amyotroph Lateral Scler. 2004;5:99–102.
   PubMed Web of Science ®Google Scholar
• Kamel F, Umbach DM, Munsat TL, Shefner JM, Hu H, Sandler DP. Lead exposure and amyotrophic lateral sclerosis. Epidemiology. 2002;13:311–9.
   PubMed Web of Science ®Google Scholar
• Chen HL, Richard M, Sandier DP, Umbach DM, Kamel F. Head injury and amyotrophic lateral sclerosis. American Journal of Epidemiology. 2007;166:810–6.
   PubMed Web of Science ®Google Scholar
• Fang F, Quinlan P, Ye W, Barber MK, Umbach DM, Sandler DP, et al. Workplace Exposures and the Risk of Amyotrophic Lateral Sclerosis. Environ Health Persp. 2009;117:1387–92.
   PubMed Web of Science ®Google Scholar
• Sorenson EJ, Stalker AP, Kurland LT, Windebank AJ. Amyotrophic lateral sclerosis in Olmsted County, Minnesota, 1925 to 1998. Neurology. 2002;59:280–2.
   PubMed Web of Science ®Google Scholar
• Mateen FJ, Carone M, Sorenson EJ. Patients who survive five years or more with ALS in Olmsted County, 1925–2004. J Neurol Neurosur Ps. 2010;81:1144–6.
   PubMed Web of Science ®Google Scholar
• Horner RD, Grambow SC, Coffman CJ, Lindquist JH, Oddone EZ, Allen KD, et al. Amyotrophic lateral sclerosis among 1991 Gulf War veterans: evidence for a time-limited outbreak. Neuroepidemiology. 2008;31:28–32.
   PubMed Web of Science ®Google Scholar
• Weisskopf MG, McCullough ML, Calle EE, Thun MJ, Cudkowicz M, Ascherio A. Prospective study of cigarette smoking and amyotrophic lateral sclerosis. Am J Epidemiol. 2004;160:26–33.
   PubMed Web of Science ®Google Scholar
• Wang H, O’Reilly EJ, Weisskopf MG, Logroscino G, McCullough ML, Thun MJ, et al. Smoking and risk of amyotrophic lateral sclerosis: a pooled analysis of five prospective cohorts. Arch Neurol. 2011;68:207–13.
   PubMed Web of Science ®Google Scholar
• Ascherio A, Weisskopf MG, O’Reilly EJ, Jacobs EJ, McCullough ML, Calle EE, et al. Vitamin E intake and risk of amyotrophic lateral sclerosis. Annals of Neurology. 2005;57:104–10.
   PubMed Web of Science ®Google Scholar
• Weisskopf MG, O’Reilly EJ, McCullough ML, Calle EE, Thun MJ, Cudkowicz M, et al. Prospective study of military service and mortality from ALS. Neurology. 2005;64:32–7.
   PubMed Web of Science ®Google Scholar
• Abhinav K, Stanton B, Johnston C, Hardstaff J, Orrell RW, Howard R, et al. Amyotrophic lateral sclerosis in South-East England: a population based study. The South-East England Register for amyotrophic lateral sclerosis (SEALS Registry). Neuroepidemiology. 2007;29:44–8.
   PubMed Web of Science ®Google Scholar
• Johnston CA, Stanton BR, Turner MR, Gray R, Blunt AH, Butt D, et al. Amyotrophic lateral sclerosis in an urban setting: a population based study of inner city London. J Neurol. 2006;253:1642–3.
   PubMed Web of Science ®Google Scholar
• Popat RA, van den Eeden SK, Tanner CM, Bernstein AL, Bloch DA, Leimpeter A, et al. Effect of reproductive factors and post-menopausal hormone use on the risk of amyotrophic lateral sclerosis. Neuroepidemiology. 2006;27:117–21.
   PubMed Web of Science ®Google Scholar
• Popat RA, Tanner CM, van den Eeden SK, Bernstein AL, Bloch DA, Leimpeter A, et al. Effect of non-steroidal anti-inflammatory medications on the risk of amyotrophic lateral sclerosis. Amyotrophic lateral sclerosis : official publication of the World Federation of Neurology Research Group on Motor Neuron Diseases. 2007;8:157–63.
   Google Scholar
• Forbes RB, Colville S, Parratt J, Swingler RJ. The incidence of motor neuron disease in Scotland. J Neurol. 2007;254: 866–9.
   PubMed Web of Science ®Google Scholar
• Chio A, Calvo A, Dossena M, Ghiglione P, Mutani R, Mora G. ALS in Italian professional soccer players: the risk is still present and could be soccer-specific. Amyotroph Lateral Scler. 2009;10:205–9.
   PubMed Web of Science ®Google Scholar
• Atsuta N, Watanabe H, Ito M, Tanaka F, Tamakoshi A, Nakano I, et al. Age at onset influences on wide-ranged clinical features of sporadic amyotrophic lateral sclerosis. J Neurol Sci. 2009;276:163–9.
   PubMed Web of Science ®Google Scholar
• Zaldivar T, Gutierrez J, Lara G, Carbonara M, Logroscino G, Hardiman O. Reduced frequency of ALS in an ethnically mixed population. Neurology. 2009;72: 1640–5.
   PubMed Web of Science ®Google Scholar
• O’Toole O, Traynor BJ, Brennan P, Sheehan C, Frost E, Corr B, et al. Epidemiology and clinical features of amyotrophic lateral sclerosis in Ireland between 1995 and 2004. J Neurol Neurosur Ps.2008;79:30–2.
   Google Scholar
• Yeo L, Lynch C, Hardiman O. Validating population based registers for ALS: how accurate is death certification?. J Neurol. 2010;257:1235–9.
   PubMed Web of Science ®Google Scholar
• Phukan J, Elamin M, Bede P, Jordan N, Gallagher L, Byrne S, et al. The syndrome of cognitive impairment in amyotrophic lateral sclerosis: a population based study. J Neurol Neurosurg Psychiatry. 2012;83:102–8.
   PubMed Web of Science ®Google Scholar
• Donaghy C, O’Toole O, Sheehan C, Kee F, Hardiman O, Patterson V. An all-Ireland epidemiological study of MND, 2004–2005. Eur J Neurol. 2009;16:148–53.
   PubMed Web of Science ®Google Scholar
• Donaghy C, Clarke J, Patterson C, Kee F, Hardiman O, Patterson V. The epidemiology of motor neuron disease in Northern Ireland using capture-recapture methodology. Amyotroph Lateral Scler. 2010;11:374–8.
   PubMed Web of Science ®Google Scholar
• Hanby MF, Scott KM, Scotton W, Wijesekera L, Mole T, Ellis CE, et al. The risk to relatives of patients with sporadic amyotrophic lateral sclerosis. Brain. 2011;134: 3454–7.
   PubMed Web of Science ®Google Scholar
• Huisman MH, de Jong SW, van Doormaal PT, Weinreich SS, Schelhaas HJ, van der Kooi AJ, et al. Population based epidemiology of amyotrophic lateral sclerosis using capture-recapture methodology. J Neurol Neurosurg Psychiatry. 2011;82:1165–70.
   PubMed Web of Science ®Google Scholar
• de Jong SW, Huisman MH, Sutedja NA, van der Kooi AJ, de Visser M, Schelhaas HJ, et al. Smoking, alcohol consumption, and the risk of amyotrophic lateral sclerosis: a population-based study. Am J Epidemiol. 2012;176: 233–9.
   PubMed Web of Science ®Google Scholar
• Beghi E, Millul A, Micheli A, Vitelli E, Logroscino G, Group S. Incidence of ALS in Lombardy, Italy. Neurology. 2007;68:141–5.
   PubMed Web of Science ®Google Scholar
• Sabatelli M, Conforti FL, Zollino M, Mora G, Monsurro MR, Volanti P, et al. C9orf72 hexanucleotide repeat expansions in the Italian sporadic ALS population. Neurobiol Aging. 2012;33:1848:e15–20.
   PubMed Web of Science ®Google Scholar
• Chio A, Calvo A, Mazzini L, Cantello R, Mora G, Moglia C, et al. Extensive genetics of ALS: a population based study in Italy. Neurology. 2012;79:1983–9.
   PubMed Web of Science ®Google Scholar
• Chio A, Calvo A, Moglia C, Gamna F, Mattei A, Mazzini L, et al. Non-invasive ventilation in amyotrophic lateral sclerosis: a 10-year population based study. J Neurol Neurosurg Psychiatry. 2012;83:377–81.
   PubMed Web of Science ®Google Scholar
• Chio A, Calvo A, Ghiglione P, Mazzini L, Mutani R, Mora G, et al. Tracheostomy in amyotrophic lateral sclerosis: a 10-year population based study in Italy. J Neurol Neurosurg Psychiatry. 2010;81:1141–3.
   PubMed Web of Science ®Google Scholar
• Chio A, Calvo A, Moglia C, Mazzini L, Mora G, group Ps. Phenotypic heterogeneity of amyotrophic lateral sclerosis: a population based study. J Neurol Neurosurg Psychiatry. 2011;82:740–6.
   PubMed Web of Science ®Google Scholar
• Logroscino G, Traynor BJ, Hardiman O, Chio A, Mitchell D, Swingler RJ, et al. Incidence of amyotrophic lateral sclerosis in Europe. J Neurol Neurosurg Psychiatry. 2010;81:385–90.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Rabkin JG, Struening EL. Live events, stress, and illness. Science. 1976;194:1013–20.
   PubMed Web of Science ®Google Scholar
• Linn MW. A Global Assessment of Recent Stress (GARS) Scale. Int J Psychiatry Med. 1985;15:47–59.
   PubMed Web of Science ®Google Scholar
• Endicott J. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993: 321–6.
   Google Scholar
• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988;54:1063–70.
   PubMed Web of Science ®Google Scholar
• Beck AT, Weissman A, Lester D, Trexler L. The measurement of pessimism: the hopelessness scale. J Consult Clin Psych. 1974;42:861–5.
   PubMed Web of Science ®Google Scholar
• Manne SL, Taylor KL, Dougherty J, Kemeny N. Supportive and negative responses in the partner relationship: their association with psychological adjustment among individuals with cancer. J Behav Med. 1997;20:101–25.
   PubMed Web of Science ®Google Scholar
• Gift AG. Visual Analog Scales - Measurement of Subjective Phenomena. Nurs Res. 1989;38:286–8.
   PubMed Web of Science ®Google Scholar