메뉴 건너뛰기




Volumn 17, Issue 1, 2016, Pages

A systematic review of randomised controlled trials in rheumatoid arthritis: The reporting and handling of missing data in composite outcomes

Author keywords

Composite outcomes; Imputation; Missing data; RA; Sensitivity analysis

Indexed keywords

AMERICAN COLLEGE OF RHEUMATOLOGY; ARTICLE; CLINICAL STUDY; DAS28; HUMAN; INFORMATION PROCESSING; INTENTION TO TREAT ANALYSIS; MUSCULOSKELETAL DISEASE ASSESSMENT; OUTCOME ASSESSMENT; PATIENT DROPOUT; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHEUMATOID ARTHRITIS; SENSITIVITY ANALYSIS; SYSTEMATIC REVIEW; TREATMENT OUTCOME; MEASUREMENT ACCURACY; METHODOLOGY; PROCEDURES; SAMPLE SIZE; STATISTICAL ANALYSIS; STATISTICAL MODEL; STATISTICS AND NUMERICAL DATA;

EID: 84971441818     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-016-1402-5     Document Type: Article
Times cited : (25)

References (33)
  • 1
    • 77957196913 scopus 로고    scopus 로고
    • Rheumatoid arthritis
    • Scott DL, Wolfe F, Huizinga TW. Rheumatoid arthritis. Lancet. 2010;376(9746):1094-108. doi: 10.1016/s0140-6736(10)60826-4.
    • (2010) Lancet , vol.376 , Issue.9746 , pp. 1094-1108
    • Scott, D.L.1    Wolfe, F.2    Huizinga, T.W.3
  • 2
    • 0027238592 scopus 로고
    • The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical Trials
    • Felson DT, Anderson JJ, Boers M, Bombardier C, Chernoff M, Fried B, et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical Trials. Arthritis Rheum. 1993;36(6):729-40.
    • (1993) Arthritis Rheum , vol.36 , Issue.6 , pp. 729-740
    • Felson, D.T.1    Anderson, J.J.2    Boers, M.3    Bombardier, C.4    Chernoff, M.5    Fried, B.6
  • 3
    • 0025169668 scopus 로고
    • Time for changes in the design, analysis, and reporting of rheumatoid arthritis clinical trials
    • Felson DT, Anderson JJ, Meenan RF. Time for changes in the design, analysis, and reporting of rheumatoid arthritis clinical trials. Arthritis Rheum. 1990;33(1):140-9.
    • (1990) Arthritis Rheum , vol.33 , Issue.1 , pp. 140-149
    • Felson, D.T.1    Anderson, J.J.2    Meenan, R.F.3
  • 4
    • 0028815803 scopus 로고
    • Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis
    • Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995;38(1):44-8.
    • (1995) Arthritis Rheum , vol.38 , Issue.1 , pp. 44-48
    • Prevoo, M.L.1    Hof, M.A.2    Kuper, H.H.3    Leeuwen, M.A.4    Putte, L.B.5    Riel, P.L.6
  • 5
    • 0029044362 scopus 로고
    • American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis
    • Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38(6):727-35.
    • (1995) Arthritis Rheum , vol.38 , Issue.6 , pp. 727-735
    • Felson, D.T.1    Anderson, J.J.2    Boers, M.3    Bombardier, C.4    Furst, D.5    Goldsmith, C.6
  • 6
    • 77749255547 scopus 로고    scopus 로고
    • Methodological issues in the use of composite endpoints in clinical trials: examples from the HIV field
    • (London, England)
    • Wittkop L, Smith C, Fox Z, Sabin C, Richert L, Aboulker JP, et al. Methodological issues in the use of composite endpoints in clinical trials: examples from the HIV field. Clinical trials (London, England). 2010;7(1):19-35. doi: 10.1177/1740774509356117.
    • (2010) Clinical trials , vol.7 , Issue.1 , pp. 19-35
    • Wittkop, L.1    Smith, C.2    Fox, Z.3    Sabin, C.4    Richert, L.5    Aboulker, J.P.6
  • 8
    • 0035818884 scopus 로고    scopus 로고
    • Valsartan Heart Failure Trial I. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure
    • Cohn JN, Tognoni G. Valsartan Heart Failure Trial I. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N Engl J Med. 2001;345(23):1667-75. doi: 10.1056/NEJMoa010713.
    • (2001) N Engl J Med , vol.345 , Issue.23 , pp. 1667-1675
    • Cohn, J.N.1    Tognoni, G.2
  • 9
    • 35648932939 scopus 로고    scopus 로고
    • Analysis of a binary composite endpoint with missing data in components
    • Quan H, Zhang D, Zhang J, Devlamynck L. Analysis of a binary composite endpoint with missing data in components. Stat Med. 2007;26(26):4703-18. doi: 10.1002/sim.2893.
    • (2007) Stat Med , vol.26 , Issue.26 , pp. 4703-4718
    • Quan, H.1    Zhang, D.2    Zhang, J.3    Devlamynck, L.4
  • 10
    • 70449369661 scopus 로고    scopus 로고
    • Measurement in clinical trials: A neglected issue for statisticians?
    • Senn S, Julious S. Measurement in clinical trials: A neglected issue for statisticians? Stat Med. 2009;28(26):3189-209. doi: 10.1002/sim.3603.
    • (2009) Stat Med , vol.28 , Issue.26 , pp. 3189-3209
    • Senn, S.1    Julious, S.2
  • 11
    • 76749124428 scopus 로고    scopus 로고
    • Missing data in randomised controlled trials-a practical guide
    • Birmingham: National Institute for Health Research, Publication RM03/JH17/MK. Accessed 30 Apr 2015.
    • Carpenter JR, Kenward MG. Missing data in randomised controlled trials-a practical guide. Birmingham: National Institute for Health Research, Publication RM03/JH17/MK. 2008. http://www.pcpoh.bham.ac.uk/publichealth/methodology/projects/RM03_JH17_MK.shtml. Accessed 30 Apr 2015.
    • (2008)
    • Carpenter, J.R.1    Kenward, M.G.2
  • 12
    • 0033546995 scopus 로고    scopus 로고
    • What is meant by intention to treat analysis? Survey of published randomised controlled trials
    • Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ (Clin Res Ed). 1999;319(7211):670-4.
    • (1999) BMJ (Clin Res Ed) , vol.319 , Issue.7211 , pp. 670-674
    • Hollis, S.1    Campbell, F.2
  • 13
    • 25144472336 scopus 로고    scopus 로고
    • Are missing outcome data adequately handled? A review of published randomized controlled trials in major medical journals
    • Wood AM, White IR, Thompson SG. Are missing outcome data adequately handled? A review of published randomized controlled trials in major medical journals. Clin Trials. 2004;1(4):368-76.
    • (2004) Clin Trials , vol.1 , Issue.4 , pp. 368-376
    • Wood, A.M.1    White, I.R.2    Thompson, S.G.3
  • 14
    • 77954399700 scopus 로고    scopus 로고
    • Consort 2010 statement on randomised controlled trials
    • Murphy JF. Consort 2010 statement on randomised controlled trials. Ir Med J. 2010;103(5):132.
    • (2010) Ir Med J , vol.103 , Issue.5 , pp. 132
    • Murphy, J.F.1
  • 15
    • 77950189829 scopus 로고    scopus 로고
    • CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials
    • Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ (Clin Res Ed). 2010;340:c332. doi: 10.1136/bmj.c332.
    • (2010) BMJ (Clin Res Ed) , vol.340 , pp. c332
    • Schulz, K.F.1    Altman, D.G.2    Moher, D.3
  • 16
    • 69149107165 scopus 로고    scopus 로고
    • Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement
    • Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009;151(4):264-9. W64.
    • (2009) Ann Intern Med. , vol.151 , Issue.4 , pp. 264-269
    • Moher, D.1    Liberati, A.2    Tetzlaff, J.3    Altman, D.G.4
  • 17
    • 84871093047 scopus 로고    scopus 로고
    • Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY)
    • Dougados M, Kissel K, Sheeran T, Tak PP, Conaghan PG, Mola EM, et al. Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY). Ann Rheum Dis. 2013;72(1):43-50. doi: 10.1136/annrheumdis-2011-201282.
    • (2013) Ann Rheum Dis , vol.72 , Issue.1 , pp. 43-50
    • Dougados, M.1    Kissel, K.2    Sheeran, T.3    Tak, P.P.4    Conaghan, P.G.5    Mola, E.M.6
  • 18
    • 52149099504 scopus 로고    scopus 로고
    • IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial
    • Emery P, Keystone E, Tony HP, Cantagrel A, van Vollenhoven R, Sanchez A, et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis. 2008;67(11):1516-23. doi: 10.1136/ard.2008.092932.
    • (2008) Ann Rheum Dis , vol.67 , Issue.11 , pp. 1516-1523
    • Emery, P.1    Keystone, E.2    Tony, H.P.3    Cantagrel, A.4    Vollenhoven, R.5    Sanchez, A.6
  • 19
    • 84855351178 scopus 로고    scopus 로고
    • Efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis and a previous inadequate response to disease-modifying antirheumatic drugs: the ROSE study
    • Yazici Y, Curtis JR, Ince A, Baraf H, Malamet RL, Teng LL, et al. Efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis and a previous inadequate response to disease-modifying antirheumatic drugs: the ROSE study. Ann Rheum Dis. 2012;71(2):198-205. doi: 10.1136/ard.2010.148700.
    • (2012) Ann Rheum Dis , vol.71 , Issue.2 , pp. 198-205
    • Yazici, Y.1    Curtis, J.R.2    Ince, A.3    Baraf, H.4    Malamet, R.L.5    Teng, L.L.6
  • 20
    • 40749114497 scopus 로고    scopus 로고
    • Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial
    • Smolen JS, Beaulieu A, Rubbert-Roth A, Ramos-Remus C, Rovensky J, Alecock E, et al. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet. 2008;371(9617):987-97. doi: 10.1016/s0140-6736(08)60453-5.
    • (2008) Lancet , vol.371 , Issue.9617 , pp. 987-997
    • Smolen, J.S.1    Beaulieu, A.2    Rubbert-Roth, A.3    Ramos-Remus, C.4    Rovensky, J.5    Alecock, E.6
  • 21
    • 67449124634 scopus 로고    scopus 로고
    • Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial
    • Smolen J, Landewe RB, Mease P, Brzezicki J, Mason D, Luijtens K, et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis. 2009;68(6):797-804. doi: 10.1136/ard.2008.101659.
    • (2009) Ann Rheum Dis , vol.68 , Issue.6 , pp. 797-804
    • Smolen, J.1    Landewe, R.B.2    Mease, P.3    Brzezicki, J.4    Mason, D.5    Luijtens, K.6
  • 22
    • 84873707323 scopus 로고    scopus 로고
    • Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial
    • Weinblatt ME, Bingham 3rd CO, Mendelsohn AM, Kim L, Mack M, Lu J, et al. Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial. Ann Rheum Dis. 2013;72(3):381-9. doi: 10.1136/annrheumdis-2012-201411.
    • (2013) Ann Rheum Dis , vol.72 , Issue.3 , pp. 381-389
    • Weinblatt, M.E.1    Bingham, C.O.2    Mendelsohn, A.M.3    Kim, L.4    Mack, M.5    Lu, J.6
  • 23
    • 84865655947 scopus 로고    scopus 로고
    • A randomized comparative effectiveness study of oral triple therapy versus etanercept plus methotrexate in early aggressive rheumatoid arthritis: the treatment of Early Aggressive Rheumatoid Arthritis Trial
    • Moreland LW, O'Dell JR, Paulus HE, Curtis JR, Bathon JM, St Clair EW, et al. A randomized comparative effectiveness study of oral triple therapy versus etanercept plus methotrexate in early aggressive rheumatoid arthritis: the treatment of Early Aggressive Rheumatoid Arthritis Trial. Arthritis Rheum. 2012;64(9):2824-35. doi: 10.1002/art.34498.
    • (2012) Arthritis Rheum , vol.64 , Issue.9 , pp. 2824-2835
    • Moreland, L.W.1    O'Dell, J.R.2    Paulus, H.E.3    Curtis, J.R.4    Bathon, J.M.5    St Clair, E.W.6
  • 24
    • 48149100741 scopus 로고    scopus 로고
    • Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial
    • Emery P, Breedveld FC, Hall S, Durez P, Chang DJ, Robertson D, et al. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial. Lancet. 2008;372(9636):375-82. doi: 10.1016/s0140-6736(08)61000-4.
    • (2008) Lancet , vol.372 , Issue.9636 , pp. 375-382
    • Emery, P.1    Breedveld, F.C.2    Hall, S.3    Durez, P.4    Chang, D.J.5    Robertson, D.6
  • 25
    • 84877275257 scopus 로고    scopus 로고
    • Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial
    • Gabay C, Emery P, van Vollenhoven R, Dikranian A, Alten R, Pavelka K, et al. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. Lancet. 2013;381(9877):1541-50.
    • (2013) Lancet , vol.381 , Issue.9877 , pp. 1541-1550
    • Gabay, C.1    Emery, P.2    Vollenhoven, R.3    Dikranian, A.4    Alten, R.5    Pavelka, K.6
  • 26
    • 84874402383 scopus 로고    scopus 로고
    • Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: twelve-month data from a twenty-four-month phase III randomized radiographic study
    • van der Heijde D, Tanaka Y, Fleischmann R, Keystone E, Kremer J, Zerbini C, et al. Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: twelve-month data from a twenty-four-month phase III randomized radiographic study. Arthritis Rheum. 2013;65(3):559-70. doi: 10.1002/art.37816.
    • (2013) Arthritis Rheum , vol.65 , Issue.3 , pp. 559-570
    • Heijde, D.1    Tanaka, Y.2    Fleischmann, R.3    Keystone, E.4    Kremer, J.5    Zerbini, C.6
  • 27
    • 84865490979 scopus 로고    scopus 로고
    • Including all individuals is not enough: lessons for intention-to-treat analysis
    • White IR, Carpenter J, Horton NJ. Including all individuals is not enough: lessons for intention-to-treat analysis. Clin Trials. 2012;9(4):396-407. doi: 10.1177/1740774512450098.
    • (2012) Clin Trials , vol.9 , Issue.4 , pp. 396-407
    • White, I.R.1    Carpenter, J.2    Horton, N.J.3
  • 28
    • 84880099876 scopus 로고    scopus 로고
    • A tutorial on sensitivity analyses in clinical trials: the what, why, when and how
    • Thabane L, Mbuagbaw L, Zhang SY, Samaan Z, Marcucci M, Ye CL, et al. A tutorial on sensitivity analyses in clinical trials: the what, why, when and how. BMC Med Res Methodol. 2013;13:92. doi: 10.1186/1471-2288-13-92.
    • (2013) BMC Med Res Methodol , vol.13 , pp. 92
    • Thabane, L.1    Mbuagbaw, L.2    Zhang, S.Y.3    Samaan, Z.4    Marcucci, M.5    Ye, C.L.6
  • 30
    • 84857231864 scopus 로고    scopus 로고
    • The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it
    • O'Neill RT, Temple R. The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it. Clin Pharmacol Ther. 2012;91(3):550-4. doi: 10.1038/clpt.2011.340.
    • (2012) Clin Pharmacol Ther , vol.91 , Issue.3 , pp. 550-554
    • O'Neill, R.T.1    Temple, R.2
  • 31
    • 79955417678 scopus 로고    scopus 로고
    • Strategy for intention to treat analysis in randomised trials with missing outcome data
    • White IR, Horton NJ, Carpenter J, Pocock SJ. Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ (Clin Res Ed). 2011;342:d40. doi: 10.1136/bmj.d40.
    • (2011) BMJ (Clin Res Ed). , vol.342 , pp. d40
    • White, I.R.1    Horton, N.J.2    Carpenter, J.3    Pocock, S.J.4
  • 32
    • 77956967268 scopus 로고    scopus 로고
    • Trial attrition study group. Assessing the impact of attrition in randomized controlled trials
    • Hewitt CE, Kumaravel B, Dumville JC, Torgerson DJ. Trial attrition study group. Assessing the impact of attrition in randomized controlled trials. J Clin Epidemiol. 2010;63(11):1264-70. doi: 10.1016/j.jclinepi.2010.01.010.
    • (2010) J Clin Epidemiol , vol.63 , Issue.11 , pp. 1264-1270
    • Hewitt, C.E.1    Kumaravel, B.2    Dumville, J.C.3    Torgerson, D.J.4
  • 33
    • 20744445181 scopus 로고    scopus 로고
    • Violation of the intent-to-treat principle and rate of missing data in superiority trials assessing structural outcomes in rheumatic diseases
    • Baron G, Boutron I, Giraudeau B, Ravaud P. Violation of the intent-to-treat principle and rate of missing data in superiority trials assessing structural outcomes in rheumatic diseases. Arthritis Rheum. 2005;52(6):1858-65. doi: 10.1002/art.21116.
    • (2005) Arthritis Rheum , vol.52 , Issue.6 , pp. 1858-1865
    • Baron, G.1    Boutron, I.2    Giraudeau, B.3    Ravaud, P.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.