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Volumn 192, Issue 32, 2020, Pages E901-E906

Development of the instrument to assess the credibility of effect modification analyses (ICEMAN) in randomized controlled trials and meta-analyses

(16)  Schandelmaier, Stefan a,b   Briel, Matthias a,b   Varadhan, Ravi c   Schmid, Christopher H d   Devasenapathy, Niveditha e   Hayward, Rodney A f   Gagnier, Joel f,g   Borenstein, Michael h   van der Heijden, Geert J M G i,j   Dahabreh, Issa J d   Sun, Xin k   Sauerbrei, Willi l   Walsh, Michael a   Ioannidis, John P A m,n   Thabane, Lehana a,o   Guyatt, Gordon H a  


Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; ARTICLE; CONSENSUS DEVELOPMENT; DELPHI STUDY; HUMAN; INSTRUMENT FOR ASSESSING THE CREDIBILITY OF EFFECT MODIFICATION ANALYSIS; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RELIABILITY; RISK ASSESSMENT; SYSTEMATIC REVIEW; VISUAL ANALOG SCALE; CONSENSUS; META ANALYSIS (TOPIC); METHODOLOGY;

EID: 85089327341     PISSN: 08203946     EISSN: 14882329     Source Type: Journal    
DOI: 10.1503/cmaj.200077     Document Type: Article
Times cited : (305)

References (47)
  • 1
    • 85067548363 scopus 로고    scopus 로고
    • How often can meta-analyses of individual-level data individualize treatment? A meta-epidemiologic study
    • Schuit E, Li AH, Ioannidis JPA. How often can meta-analyses of individual-level data individualize treatment? A meta-epidemiologic study. Int J Epidemiol 2019;48:596-608.
    • (2019) Int J Epidemiol , vol.48 , pp. 596-608
    • Schuit, E1    Li, AH2    Ioannidis, JPA.3
  • 2
    • 84978251081 scopus 로고    scopus 로고
    • No improvement in the reporting of clinical trial subgroup effects in high-impact general medical journals
    • Gabler NB, Duan N, Raneses E, et al. No improvement in the reporting of clinical trial subgroup effects in high-impact general medical journals. Trials 2016;17:320.
    • (2016) Trials , vol.17 , pp. 320
    • Gabler, NB1    Duan, N2    Raneses, E3
  • 3
    • 84955329833 scopus 로고    scopus 로고
    • A decade of individual participant data meta-analyses: a review of current practice
    • Simmonds M, Stewart G, Stewart L. A decade of individual participant data meta-analyses: a review of current practice. Contemp Clin Trials 2015;45:76-83.
    • (2015) Contemp Clin Trials , vol.45 , pp. 76-83
    • Simmonds, M1    Stewart, G2    Stewart, L.3
  • 4
    • 84933508215 scopus 로고    scopus 로고
    • Subgroup analyses in reporting of phase III clinical trials in solid tumors
    • Zhang S, Liang F, Li W, et al. Subgroup analyses in reporting of phase III clinical trials in solid tumors. J Clin Oncol 2015;33:1697-702.
    • (2015) J Clin Oncol , vol.33 , pp. 1697-1702
    • Zhang, S1    Liang, F2    Li, W3
  • 5
    • 84934893163 scopus 로고    scopus 로고
    • Exploring treatment by covariate interactions using subgroup analysis and meta-regression in Cochrane reviews: a review of recent practice
    • Donegan S, Williams L, Dias S, et al. Exploring treatment by covariate interactions using subgroup analysis and meta-regression in Cochrane reviews: a review of recent practice. PLoS One 2015;10:e0128804.
    • (2015) PLoS One , vol.10 , pp. e0128804
    • Donegan, S1    Williams, L2    Dias, S3
  • 6
    • 84959562615 scopus 로고    scopus 로고
    • The influence of industry sponsorship on the reporting of subgroup analyses within phase III randomised controlled trials in gastrointestinal oncology
    • Barton SP, Peckitt C, Sclafani F, et al. The influence of industry sponsorship on the reporting of subgroup analyses within phase III randomised controlled trials in gastrointestinal oncology. Eur J Cancer 2015;51:2732-9.
    • (2015) Eur J Cancer , vol.51 , pp. 2732-2739
    • Barton, SP1    Peckitt, C2    Sclafani, F3
  • 8
    • 85090472286 scopus 로고    scopus 로고
    • erratum in BMJ 2014;349:4921
    • erratum in BMJ 2014;349:4921. BMJ 2014;349:g4539.
    • (2014) BMJ , vol.349 , pp. g4539
  • 9
    • 84859726995 scopus 로고    scopus 로고
    • Credibility of claims of subgroup effects in randomised controlled trials: systematic review
    • Sun X, Briel M, Busse JW, et al. Credibility of claims of subgroup effects in randomised controlled trials: systematic review. BMJ 2012;344:e1553.
    • (2012) BMJ , vol.344 , pp. e1553
    • Sun, X1    Briel, M2    Busse, JW3
  • 10
    • 36348939350 scopus 로고    scopus 로고
    • Statistics in medicine - reporting of subgroup analyses in clinical trials
    • Wang R, Lagakos SW, Ware JH, et al. Statistics in medicine - reporting of subgroup analyses in clinical trials. N Engl J Med 2007;357:2189-94.
    • (2007) N Engl J Med , vol.357 , pp. 2189-2194
    • Wang, R1    Lagakos, SW2    Ware, JH3
  • 11
    • 34548604673 scopus 로고    scopus 로고
    • A systematic review of analytical methods used to study subgroups in (individual patient data) meta-analyses
    • Koopman L, van der Heijden GJ, Glasziou PP, et al. A systematic review of analytical methods used to study subgroups in (individual patient data) meta-analyses. J Clin Epidemiol 2007;60:1002-9.
    • (2007) J Clin Epidemiol , vol.60 , pp. 1002-1009
    • Koopman, L1    van der Heijden, GJ2    Glasziou, PP3
  • 12
    • 31444441393 scopus 로고    scopus 로고
    • Subgroup analyses in therapeutic cardiovascular clinical trials: Are most of them misleading?
    • Hernández AV, Boersma E, Murray GD, et al. Subgroup analyses in therapeutic cardiovascular clinical trials: Are most of them misleading? Am Heart J 2006; 151:257-64.
    • (2006) Am Heart J , vol.151 , pp. 257-264
    • Hernández, AV1    Boersma, E2    Murray, GD3
  • 13
    • 33746037645 scopus 로고    scopus 로고
    • Misuse of baseline comparison tests and subgroup analyses in surgical trials
    • Bhandari M, Devereaux PJ, Li P, et al. Misuse of baseline comparison tests and subgroup analyses in surgical trials. Clin Orthop Relat Res 2006;447:247-51.
    • (2006) Clin Orthop Relat Res , vol.447 , pp. 247-251
    • Bhandari, M1    Devereaux, PJ2    Li, P3
  • 14
    • 0035670040 scopus 로고    scopus 로고
    • Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals
    • Moreira ED Jr, Stein Z, Susser E. Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals. Braz J Med Biol Res 2001;34: 1441-6.
    • (2001) Braz J Med Biol Res , vol.34 , pp. 1441-1446
    • Moreira, ED1    Stein, Z2    Susser, E.3
  • 15
    • 0034712491 scopus 로고    scopus 로고
    • Subgroup analysis and other (mis)uses of baseline data in clinical trials
    • Assmann SF, Pocock SJ, Enos LE, et al. Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet 2000;355:1064-9.
    • (2000) Lancet , vol.355 , pp. 1064-1069
    • Assmann, SF1    Pocock, SJ2    Enos, LE3
  • 16
    • 0017393590 scopus 로고
    • Controlled trial of aspirin in cerebral ischemia
    • Fields WS, Lemak NA, Frankowski RF, et al. Controlled trial of aspirin in cerebral ischemia. Stroke 1977;8:301-14.
    • (1977) Stroke , vol.8 , pp. 301-314
    • Fields, WS1    Lemak, NA2    Frankowski, RF3
  • 17
    • 0018138512 scopus 로고
    • A randomized trial of aspirin and sulfinpyrazone in threatened stroke
    • Canadian Cooperative Study Group
    • Canadian Cooperative Study Group. A randomized trial of aspirin and sulfinpyrazone in threatened stroke. N Engl J Med 1978;299:53-9.
    • (1978) N Engl J Med , vol.299 , pp. 53-59
  • 19
    • 0003186852 scopus 로고
    • erratum in BMJ 1994;308:1540
    • erratum in BMJ 1994;308:1540. BMJ 1994;308:81-106.
    • (1994) BMJ , vol.308 , pp. 81-106
  • 20
    • 0022846399 scopus 로고
    • Influence of antihypertensive drug treatment on morbidity and mortality in patients over the age of 60 years. European Working Party on High blood pressure in the Elderly (EWPHE) results: subgroup analysis on entry stratification
    • Amery A, Birkenhäger W, Brixko P, et al. Influence of antihypertensive drug treatment on morbidity and mortality in patients over the age of 60 years. European Working Party on High blood pressure in the Elderly (EWPHE) results: subgroup analysis on entry stratification. J Hypertens Suppl 1986;4:S642-7.
    • (1986) J Hypertens Suppl , vol.4 , pp. S642-S647
    • Amery, A1    Birkenhäger, W2    Brixko, P3
  • 21
    • 0033528524 scopus 로고    scopus 로고
    • Antihypertensive drugs in very old people: a subgroup meta-analysis of randomised controlled trials. INDANA Group
    • Gueyffier F, Bulpitt C, Boissel JP, et al. Antihypertensive drugs in very old people: a subgroup meta-analysis of randomised controlled trials. INDANA Group. Lancet 1999;353:793-6.
    • (1999) Lancet , vol.353 , pp. 793-796
    • Gueyffier, F1    Bulpitt, C2    Boissel, JP3
  • 22
    • 0027455486 scopus 로고    scopus 로고
    • The efficacy and safety of ticlopidine and aspirin in non-whites: analysis of a patient subgroup from the Ticlopidine Aspirin Stroke Study
    • Weisberg LA. The efficacy and safety of ticlopidine and aspirin in non-whites: analysis of a patient subgroup from the Ticlopidine Aspirin Stroke Study. Neurology1993;43:27-31.
    • Neurology1993 , vol.43 , pp. 27-31
    • Weisberg, LA.1
  • 23
    • 0038142850 scopus 로고    scopus 로고
    • Aspirin and ticlopidine for prevention of recurrent stroke in black patients: a randomized trial
    • African American Antiplatelet Stroke Prevention Study Investigators
    • Gorelick PB, Richardson D, Kelly M, et al.; African American Antiplatelet Stroke Prevention Study Investigators. Aspirin and ticlopidine for prevention of recurrent stroke in black patients: a randomized trial. JAMA 2003;289:2947-57.
    • (2003) JAMA , vol.289 , pp. 2947-2957
    • Gorelick, PB1    Richardson, D2    Kelly, M3
  • 24
    • 11844302840 scopus 로고    scopus 로고
    • Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation
    • Rothwell PM. Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. Lancet 2005;365: 176-86.
    • (2005) Lancet , vol.365 , pp. 176-186
    • Rothwell, PM.1
  • 26
    • 85018193823 scopus 로고    scopus 로고
    • Evaluation of evidence of statistical support and corroboration of subgroup claims in randomized clinical trials
    • Wallach JD, Sullivan PG, Trepanowski JF, et al. Evaluation of evidence of statistical support and corroboration of subgroup claims in randomized clinical trials. JAMA Intern Med 2017;177:554-60.
    • (2017) JAMA Intern Med , vol.177 , pp. 554-560
    • Wallach, JD1    Sullivan, PG2    Trepanowski, JF3
  • 27
    • 85067701060 scopus 로고    scopus 로고
    • A systematic survey identified 36 criteria for assessing effect modification claims in randomized trials or meta-analyses
    • Schandelmaier S, Chang Y, Devasenapathy N, et al. A systematic survey identified 36 criteria for assessing effect modification claims in randomized trials or meta-analyses. J Clin Epidemiol 2019;113:159-67.
    • (2019) J Clin Epidemiol , vol.113 , pp. 159-167
    • Schandelmaier, S1    Chang, Y2    Devasenapathy, N3
  • 28
    • 85017107370 scopus 로고    scopus 로고
    • Using group data to treat individuals: understanding heterogeneous treatment effects in the age of precision medicine and patient-centred evidence
    • Dahabreh IJ, Hayward R, Kent DM. Using group data to treat individuals: understanding heterogeneous treatment effects in the age of precision medicine and patient-centred evidence. Int J Epidemiol 2016;45:2184-93.
    • (2016) Int J Epidemiol , vol.45 , pp. 2184-2193
    • Dahabreh, IJ1    Hayward, R2    Kent, DM.3
  • 29
    • 46749139936 scopus 로고    scopus 로고
    • Empirical comparison of subgroup effects in conventional and individual patient data meta-analyses
    • Koopman L, van der Heijden GJ, Hoes AW, et al. Empirical comparison of subgroup effects in conventional and individual patient data meta-analyses. Int J Technol Assess Health Care 2008;24:358-61.
    • (2008) Int J Technol Assess Health Care , vol.24 , pp. 358-361
    • Koopman, L1    van der Heijden, GJ2    Hoes, AW3
  • 30
    • 85014756610 scopus 로고    scopus 로고
    • Meta-analytical methods to identify who benefits most from treatments: Daft, deluded, or deft approach?
    • Fisher DJ, Carpenter JR, Morris TP, et al. Meta-analytical methods to identify who benefits most from treatments: Daft, deluded, or deft approach? BMJ 2017;356:j573.
    • (2017) BMJ , vol.356 , pp. j573
    • Fisher, DJ1    Carpenter, JR2    Morris, TP3
  • 31
    • 0037083255 scopus 로고    scopus 로고
    • Individual patient- versus group-level data meta-regressions for the investigation of treatment effect modifiers: ecological bias rears its ugly head
    • Anti-Lymphocyte Antibody Induction Therapy Study Group
    • Berlin JA, Santanna J, Schmid CH, et al.; Anti-Lymphocyte Antibody Induction Therapy Study Group. Individual patient- versus group-level data meta-regressions for the investigation of treatment effect modifiers: ecological bias rears its ugly head. Stat Med 2002;21:371-87.
    • (2002) Stat Med , vol.21 , pp. 371-387
    • Berlin, JA1    Santanna, J2    Schmid, CH3
  • 32
    • 0025737883 scopus 로고
    • Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials
    • Yusuf S, Wittes J, Probstfield J, et al. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA 1991;266: 93-8.
    • (1991) JAMA , vol.266 , pp. 93-98
    • Yusuf, S1    Wittes, J2    Probstfield, J3
  • 33
    • 0026501239 scopus 로고
    • A consumer's guide to subgroup analyses
    • Oxman AD, Guyatt GH. A consumer's guide to subgroup analyses. Ann Intern Med 1992;116:78-84.
    • (1992) Ann Intern Med , vol.116 , pp. 78-84
    • Oxman, AD1    Guyatt, GH.2
  • 34
    • 77951082212 scopus 로고    scopus 로고
    • Is a subgroup effect believable? Updating criteria to evaluate the credibility of subgroup analyses
    • Sun X, Briel M, Walter SD, et al. Is a subgroup effect believable? Updating criteria to evaluate the credibility of subgroup analyses. BMJ 2010;340:c117.
    • (2010) BMJ , vol.340 , pp. c117
    • Sun, X1    Briel, M2    Walter, SD3
  • 36
    • 85031676861 scopus 로고    scopus 로고
    • A proposed framework for developing quality assessment tools
    • Whiting P, Wolff R, Mallett S, et al. A proposed framework for developing quality assessment tools. Syst Rev 2017;6:204.
    • (2017) Syst Rev , vol.6 , pp. 204
    • Whiting, P1    Wolff, R2    Mallett, S3
  • 37
    • 85031044770 scopus 로고    scopus 로고
    • A revised tool for assessing risk of bias in randomized trials
    • (Suppl 1)
    • Higgins J, Sterne J, Savović J, et al. A revised tool for assessing risk of bias in randomized trials. Cochrane Database Syst Rev 2016;(Suppl 1):29-31.
    • (2016) Cochrane Database Syst Rev , pp. 29-31
    • Higgins, J1    Sterne, J2    Savović, J3
  • 38
    • 84977504852 scopus 로고    scopus 로고
    • GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction
    • Alonso-Coello P, Schünemann HJ, Moberg J, et al. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ 2016;353:i2016.
    • (2016) BMJ , vol.353 , pp. i2016
    • Alonso-Coello, P1    Schünemann, HJ2    Moberg, J3
  • 39
    • 84884182515 scopus 로고    scopus 로고
    • Interaction of treatment with a continuous variable: simulation study of significance level for several methods of analysis
    • Royston P, Sauerbrei W. Interaction of treatment with a continuous variable: simulation study of significance level for several methods of analysis. Stat Med 2013;32:3788-803.
    • (2013) Stat Med , vol.32 , pp. 3788-3803
    • Royston, P1    Sauerbrei, W.2
  • 40
    • 84939166778 scopus 로고    scopus 로고
    • Interaction of treatment with a continuous variable: simulation study of power for several methods of analysis
    • Royston P, Sauerbrei W. Interaction of treatment with a continuous variable: simulation study of power for several methods of analysis. Stat Med 2014;33: 4695-708.
    • (2014) Stat Med , vol.33 , pp. 4695-4708
    • Royston, P1    Sauerbrei, W.2
  • 41
    • 84980343984 scopus 로고    scopus 로고
    • Tutorial in biostatistics: data-driven subgroup identification and analysis in clinical trials
    • Lipkovich I, Dmitrienko A, D'Agostino BR Sr. Tutorial in biostatistics: data-driven subgroup identification and analysis in clinical trials. Stat Med 2017;36: 136-96.
    • (2017) Stat Med , vol.36 , pp. 136-196
    • Lipkovich, I1    Dmitrienko, A2    D'Agostino, BR3
  • 42
    • 85035129830 scopus 로고    scopus 로고
    • Multiplicity issues in exploratory subgroup analysis
    • Lipkovich I, Dmitrienko A, Muysers C, et al. Multiplicity issues in exploratory subgroup analysis. J Biopharm Stat 2018;28:63-81.
    • (2018) J Biopharm Stat , vol.28 , pp. 63-81
    • Lipkovich, I1    Dmitrienko, A2    Muysers, C3
  • 43
    • 4344621625 scopus 로고    scopus 로고
    • A new approach to modelling interactions between treatment and continuous covariates in clinical trials by using fractional polynomials
    • Royston P, Sauerbrei W. A new approach to modelling interactions between treatment and continuous covariates in clinical trials by using fractional polynomials. Stat Med 2004;23:2509-25.
    • (2004) Stat Med , vol.23 , pp. 2509-2525
    • Royston, P1    Sauerbrei, W.2
  • 44
    • 84875635184 scopus 로고    scopus 로고
    • Meta-analysis and subgroups
    • Borenstein M, Higgins JP. Meta-analysis and subgroups. Prev Sci 2013;14: 134-43.
    • (2013) Prev Sci , vol.14 , pp. 134-143
    • Borenstein, M1    Higgins, JP.2
  • 45
    • 84887241280 scopus 로고    scopus 로고
    • Traditional multiplicity adjustment methods in clinical trials
    • Dmitrienko A, D'Agostino R Sr. Traditional multiplicity adjustment methods in clinical trials. Stat Med 2013;32:5172-218.
    • (2013) Stat Med , vol.32 , pp. 5172-5218
    • Dmitrienko, A1    D'Agostino, R2
  • 46
    • 84952863672 scopus 로고    scopus 로고
    • Treatment effect heterogeneity for univariate subgroups in clinical trials: shrinkage, standardization, or else
    • Varadhan R, Wang SJ. Treatment effect heterogeneity for univariate subgroups in clinical trials: shrinkage, standardization, or else. Biom J 2016;58:133-53.
    • (2016) Biom J , vol.58 , pp. 133-153
    • Varadhan, R1    Wang, SJ.2
  • 47
    • 84891765135 scopus 로고    scopus 로고
    • Standardization for subgroup analysis in randomized controlled trials
    • Varadhan R, Wang SJ. Standardization for subgroup analysis in randomized controlled trials. J Biopharm Stat 2014;24:154-67.
    • (2014) J Biopharm Stat , vol.24 , pp. 154-167
    • Varadhan, R1    Wang, SJ.2


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