Subgroup analyses in therapeutic cardiovascular clinical trials: Are most of them misleading?

Hernández, Adrián V.; Boersma, Eric; Murray, Gordon D.; Habbema, J. Dik F.; Steyerberg, Ewout W.

doi:10.1016/j.ahj.2005.04.020

Cited by 131Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsStatistical Methods in Epidemiology

Subgroup analyses in therapeutic cardiovascular clinical trials: Are most of them misleading?

Hernández, Adrián V., Boersma, Eric, Murray, Gordon D., Habbema, J. Dik F., Steyerberg, Ewout W.·2006·American Heart Journal

DOI 10.1016/j.ahj.2005.04.020

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Abstract

Background Treatment decisions in clinical cardiology are directed by results from randomized clinical trials (RCTs). We studied the appropriateness of the use and interpretation of subgroup analysis in current therapeutic cardiovascular RCTs.Methods We reviewed main reports of phase 3 cardiovascular RCTs with at least 100 patients, published in 2002 and 2004, and from major journals (Circulation, J Am Coll Cardiol, Am Heart J, Am J Cardiol, N Engl J Med, Lancet, JAMA, BMJ, Ann Intern Med). Information on subgroups included prespecification, number, interaction test use, significant subgroups found, and emphasis on findings. We examined appropriateness of reporting and differences according to sample size, overall trial result, and CONSORT adoption.Results We selected 63 RCTs, with a median of 496 (range 100-15,245) patients. Thirty-nine RCTs were reported with subgroup analyses and 26 with > 5 subgroups. No trial was specifically powered to detect subgroup effects, and only 14 RCTs were reported with fully prespecified subgroups. Only 11 RCTs were reported with interaction tests. Furthermore, 21 RCTs were reported with claims of significant subgroups and 15 with equal or more emphasis to subgroups than to the overall results. Subgroup analyses in large RCTs (> 500 patients) were reported more often than in small ones (24/30 vs 15/33, P = .005). No differences were found according to overall result (positive/negative) or CONSORT adoption.Conclusions Subgroup analyses in recent cardiovascular RCTs were reported with several shortcomings, including a lack of prespecification and testing of a large number of subgroups without the use of the statistically appropriate test for interaction. Reporting of subgroup analysis needs to be substantially improved because emphasis on these secondary results may mislead treatment decisions.

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In 2006, Hernandez et al reported similar results after investigating published cardiovascular RCTs.
“In 2006, Hernandez et al 4 reported similar results after investigating published cardiovascular RCTs.”
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Debate: Subgroup analyses in clinical trials: fun to look at - but don't believe them!
Sleight, P. (2000) · Trials · doi:10.1186/cvm-1-1-025 · Cited by 135 · see citing works
Lessons Learned From Recent Cardiovascular Clinical Trials: Part II
DeMets, D. L., & Califf, R. M. (2002) · Circulation · doi:10.1161/01.cir.0000023220.26465.89 · Cited by 122 · see citing works
Thrombolytic therapy for women with myocardial infarction: Is there a gender gap?
Lincoff, A. M., Califf, R. M., Ellis, S. G., Sigmon, K. N., Lee, K. L., Leimbergerphd, J. D., & Topol, E. J. (1993) · Journal of the American College of Cardiology · doi:10.1016/0735-1097(93)90757-r · Cited by 115 · see citing works
Nurse case management of hypercholesterolemia in patients with coronary heart disease: Results of a randomized clinical trial
Allen, J. K., Blumenthal, R. S., Margolis, S., Young, D. R., Miller, E. R., & Kelly, K. J. (2002) · American Heart Journal · doi:10.1067/mhj.2002.124837 · Cited by 109 · see citing works
ACST: which subgroups will benefit most from carotid endarterectomy?
Rothwell, P. M. (2004) · The Lancet · doi:10.1016/s0140-6736(04)17090-6 · Cited by 109 · see citing works
Lessons Learned From Recent Cardiovascular Clinical Trials: Part I
DeMets, D. L., & Califf, R. M. (2002) · Circulation · doi:10.1161/01.cir.0000023219.51483.66 · Cited by 104 · see citing works
Effect of pravastatin compared with placebo initiated within 24 hours of onset of acute myocardial infarction or unstable angina: The Pravastatin in Acute Coronary Treatment (PACT) trial
Thompson, P. L., Meredith, I. T., Amerena, J. V., Campbell, T. J., Sloman, J. G., & Harris, P. J. (2004) · American Heart Journal · doi:10.1016/j.ahj.2003.10.052 · Cited by 103 · see citing works
Primary stenting of occluded native coronary arteries: Final results of the Primary Stenting of Occluded Native Coronary Arteries (PRISON) study
Rahel, B. M., SUTTORP, M. J., Laarman, G., Kiemeneij, F., Bal, E. T., Rensing, B. J. W. M., Ernst, S. M. P. G., ten Berg, J. M., Kelder, J. C., & Plokker, H. W. T. (2004) · American Heart Journal · doi:10.1016/j.ahj.2003.11.023 · Cited by 98 · see citing works
Effects of atorvastatin on fasting and postprandial lipoprotein subclasses in coronary heart disease patients versus control subjects
Schaefer, E. J., McNamara, J. R., Tayler, T. D., Daly, J. A., Gleason, J. A., SEMAN, L. J., Ferrari, A., & Rubenstein, J. J. (2002) · The American Journal of Cardiology · doi:10.1016/s0002-9149(02)02591-2 · Cited by 90 · see citing works
Effect of a cardiac rehabilitation program on left ventricular diastolic function and its relationship to exercise capacity in patients with coronary heart disease: Experience from a randomized, controlled study
Yu, C., Li, L. S.-W., Lam, M.-F., Siu, D. C. W., Miu, R. K.-M., & Lau, C. (2004) · American Heart Journal · doi:10.1016/j.ahj.2003.12.004 · Cited by 89 · see citing works
Comparison in patients having primary coronary angioplasty of abciximab versus tirofiban on recovery of left ventricular function
Danzi, G. B., Sesana, M., Capuano, C., Mauri, L., Centurini, P. B., & Baglini, R. (2004) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2004.03.026 · Cited by 75 · see citing works
The microsomal triglyceride transfer protein-493T allele confers increased risk of coronary heart disease
Ledmyr, H., McMahon, A. D., Ehrenborg, E., Lithell, H., Packard, C. J., & Karpe, F. (2002) · Circulation · Cited by 72 · see citing works
Lack of efficacy of clopidogrel pre-treatment in the prevention of myocardial damage after elective stent implantation
van der Heijden, D. J., Westendorp, I. C. D., Riezebos, R. K., Kiemeneij, F., Slagboom, T., van der Wieken, L. R., & Laarman, G. (2004) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2004.02.056 · Cited by 60 · see citing works
A randomized evaluation of the effects of glucose-insulin-potassium infusion on myocardial salvage in patients with acute myocardial infarction treated with reperfusion therapy
Pache, J., Kastrati, A., Mehilli, J., Bollwein, H., Ndrepepa, G., Schühlen, H., Martinoff, S. A., Seyfarth, M., Nekolla, S. G., Dirschinger, J., et al. (2004) · American Heart Journal · doi:10.1016/j.ahj.2004.01.019 · Cited by 59 · see citing works
Subgroups, treatment effects, and baseline risks: Some lessons from major cardiovascular trials
Parker, A. B., & Naylor, C. D. (2000) · American Heart Journal · doi:10.1067/mhj.2000.106610 · Cited by 57 · see citing works
The Clinician as Investigator
Lader, E. W., Cannon, C. P., Ohman, E. M., Newby, L. K., Sulmasy, D. P., Barst, R. J., Fair, J. M., Flather, M. D., Freedman, J. E., Frye, R. L., et al. (2004) · Circulation · doi:10.1161/01.cir.0000128702.16441.75 · Cited by 49 · see citing works
Preventing increases in early-morning blood pressure, heart rate, and the rate-pressure product with controlled onset extended release verapamil at bedtime versus enalapril, losartan, and placebo on arising
White, W. B., Sica, D. A., Calhoun, D. A., Mansoor, G. A., & Anders, R. J. (2002) · American Heart Journal · doi:10.1067/mhj.2002.124866 · Cited by 41 · see citing works
Differential Treatment Benefit of Platelet Glycoprotein IIb/IIIa Inhibition With Percutaneous Coronary Intervention Versus Medical Therapy for Acute Coronary Syndromes
Pieper, K. S., Tsiatis, A. A., Davidian, M., Hasselblad, V., Kleiman, N. S., Boersma, E. H., Chang, W.-C., Griffin, J., Armstrong, P. W., Califf, R. M., et al. (2004) · Circulation · doi:10.1161/01.cir.0000112570.97220.89 · Cited by 36 · see citing works
Self-citation
Trials within Trials
Moyé, L. A., & Deswal, A. M. (2001) · Controlled Clinical Trials · doi:10.1016/s0197-2456(01)00180-5 · Cited by 35 · see citing works
Evaluation of the effect of oral verapamil on clinical outcome and angiographic restenosis after percutaneous coronary intervention
Bestehorn, H.-P., Neumann, F., Büttner, H. J., Betz, P., Stürzenhofecker, P., von Hodenberg, E., Verdun, A., Levai, L., Monassier, J. P., & Roskamm, H. (2004) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2004.02.047 · Cited by 34 · see citing works
Comparison of early and late results of a Carbofilm-coated stent versus a pure high-grade stainless steel stent (the Carbostent-Trial)
Sick, P. B., Gelbrich, G., Kalnins, U., Ērglis, A., Bonan, R., Aengevaeren, W. R. M., Elsner, D., Lauer, B., Woinke, M., Brosteanu, O., et al. (2004) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2004.02.029 · Cited by 33 · see citing works
Randomized comparison of success and adverse event rates and cost effectiveness of one long versus two short stents for treatment of long coronary narrowings
Hoffmann, R., Herrmann, G., Silber, S., Braun, P., Werner, G. S., Hennen, B., Rupprecht, H., Dahl, J., & Hanrath, P. (2002) · The American Journal of Cardiology · doi:10.1016/s0002-9149(02)02514-6 · Cited by 32 · see citing works
Post hoc subgroup analysis and the truth of a clinical trial
Adams, K. F. (1998) · American Heart Journal · doi:10.1016/s0002-8703(98)70116-4 · Cited by 31 · see citing works
Is direct coronary stenting the best strategy for long-term outcome? Results of the multicentric randomized benefit evaluation of direct coronary stenting (BET) study
Elbaz, M. (2002) · American Heart Journal · doi:10.1016/s0002-8703(02)00146-1 · Cited by 25 · see citing works
Effects of a brief course of azithromycin on soluble cell adhesion molecules and markers of inflammation in survivors of an acute coronary syndrome: a double-blind, randomized, placebo-controlled study
Hillis, G. S., Pearson, C. V., Harding, S. A., Sutherland, S., Ludlam, C. A., Marioni, J. C., Prescott, R. J., Fox, K. A. A., & Flapan, A. D. (2004) · American Heart Journal · doi:10.1016/j.ahj.2004.01.016 · Cited by 24 · see citing works
The Clinician as Investigator
Lader, E. W., Cannon, C. P., Ohman, E. M., Newby, L. K., Sulmasy, D. P., Barst, R. J., Fair, J. M., Flather, M. D., Freedman, J. E., Frye, R. L., et al. (2004) · Circulation · doi:10.1161/01.cir.0000129020.43304.a7 · Cited by 22 · see citing works
Randomized comparison of balloon angioplasty versus silicon Carbon-Coated stent implantation for de novo lesions in small coronary arteries
Hanekamp, C. E., Koolen, J., Bonnier, H. J. R. M., Oldroyd, K. G., de Boer, M., Heublein, B., & Visser, C. A. (2004) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2004.01.066 · Cited by 20 · see citing works
Medical treatment of myocardial ischemia in coronary artery disease: effect of drug regime and irregular dosing in the CAPE II trial
Deanfield, J. E., Detry, J.-M. R., Sellier, P., Lichtlen, P. R., Thaulow, E., Bultas, J., Brennan, C., Young, S. T., & Beckerman, B. (2002) · Journal of the American College of Cardiology · doi:10.1016/s0735-1097(02)02050-8 · Cited by 19 · see citing works
Esmolol in acute ischemic syndromes
Mitchell, R. G., Stoddard, M. F., Ben‐Yehuda, O., Aggarwal, K. B., Allenby, K. S., Trillo, R. A., Loyd, R., Chang, C., & Labovitz, A. J. (2002) · American Heart Journal · doi:10.1067/mhj.2002.126114 · Cited by 18 · see citing works
Is direct coronary stenting the best strategy for long-term outcome? Results of the multicentric randomized benefit evaluation of direct coronary stenting (BET) study
Elbaz, M., Mokhtar, E. E., Khalifé, K., Citron, B., Izaaz, K., Hamon, M., Juliard, J. M., Leclercq, F., Fourcade, J., Lipiecki, J., et al. (2002) · American Heart Journal · doi:10.1067/mhj.2002.125324 · Cited by 16 · see citing works
Debulking and stenting versus debulking only of coronary artery disease in patients treated with cilostazol (final results of ESPRIT)
Tsuchikane, E., Kobayashi, T., Kobayashi, T., Takeda, Y., Otsuji, S., Sakurai, M., & Awata, N. (2002) · The American Journal of Cardiology · doi:10.1016/s0002-9149(02)02588-2 · Cited by 9 · see citing works

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SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Chan, A.-W., Tetzlaff, J. M., Gotzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., Dickersin, K., Hrobjartsson, A., Schulz, K. F., Parulekar, W. R., et al. (2013) · BMJ · doi:10.1136/bmj.e7586 · Cited by 6,251 · see citing works
Consolidated Health Economic Evaluation Reporting Standards (CHEERS)—Explanation and Elaboration: A Report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force
Husereau, D., Drummond, M., Petrou, S., Carswell, C., Moher, D., Greenberg, D., Augustovski, F., Briggs, A. H., Mauskopf, J., & Loder, E. (2013) · Value in Health · doi:10.1016/j.jval.2013.02.002 · Cited by 1,998 · see citing works
Bivalirudin for Patients with Acute Coronary Syndromes
Stone, G. W., McLaurin, B. T., Cox, D. A., Bertrand, M. E., Lincoff, A. M., Moses, J. W., White, H. D., Pocock, S., Ware, J. H., Feit, F., et al. (2006) · New England Journal of Medicine · doi:10.1056/nejmoa062437 · Cited by 1,461 · see citing works
Statistics in Medicine — Reporting of Subgroup Analyses in Clinical Trials
Wang, R., Lagakos, S. W., Ware, J. H., Hunter, D. J., & Drazen, J. M. (2007) · New England Journal of Medicine · doi:10.1056/nejmsr077003 · Cited by 1,445 · see citing works
Regional Variation in Patients and Outcomes in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) Trial
Pfeffer, M. A., Claggett, B. L., Assmann, S. F., Boineau, R., Anand, I. S., Clausell, N., Desai, A. S., Díaz, R., Fleg, J. L., Gordeev, I. G., et al. (2014) · Circulation · doi:10.1161/circulationaha.114.013255 · Cited by 1,066 · see citing works
Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 Explanation and Elaboration: A Report of the ISPOR CHEERS II Good Practices Task Force
Husereau, D., Drummond, M., Augustovski, F., de Bekker-Grob, E., Briggs, A. H., Carswell, C., Caulley, L., Chaiyakunapruk, N., Greenberg, D., Loder, E., et al. (2022) · Value in Health · doi:10.1016/j.jval.2021.10.008 · Cited by 847 · see citing works
Development of the instrument to assess the credibility of effect modification analyses (ICEMAN) in randomized controlled trials and meta-analyses
Schandelmaier, S., Briel, M., Varadhan, R., Schmid, C. H., Devasenapathy, N., Hayward, R. A., Gagnier, J., Borenstein, M., van der Heijden, G. J. M. G., Dahabreh, I. J., et al. (2020) · Canadian Medical Association Journal · doi:10.1503/cmaj.200077 · Cited by 749 · see citing works
Comparison of an Everolimus-Eluting Stent and a Paclitaxel-Eluting Stent in Patients With Coronary Artery Disease
Stone, G. W. (2008) · JAMA · doi:10.1001/jama.299.16.1903 · Cited by 580 · see citing works
Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal
Kent, D. M., Rothwell, P. M., Ioannidis, J. P., Altman, D. G., & Hayward, R. A. (2010) · Trials · doi:10.1186/1745-6215-11-85 · Cited by 504 · see citing works
Personalized evidence based medicine: predictive approaches to heterogeneous treatment effects
Kent, D. M., Steyerberg, E. W., & Klaveren, D. V. (2018) · BMJ · doi:10.1136/bmj.k4245 · Cited by 487 · see citing works
Self-citation
The Predictive Approaches to Treatment effect Heterogeneity (PATH) statement
Kent, D. M., Paulus, J. K., van Klaveren, D., D'Agostino, R., Goodman, S., Hayward, R., Ioannidis, J. P. A., Patrick-Lake, B., Morton, S., Pencina, M., et al. (2020) · Annals of Internal Medicine · doi:10.7326/m18-3667 · Cited by 469 · see citing works
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Credibility of claims of subgroup effects in randomised controlled trials: systematic review
Sun, X., Briel, M., Busse, J. W., You, J. J., Akl, E. A., Mejza, F., Bała, M. M., Bassler, D., Mertz, D., Diaz-Granados, N., et al. (2012) · BMJ · doi:10.1136/bmj.e1553 · Cited by 394 · see citing works
Examining the Evidence: A Systematic Review of the Inclusion and Analysis of Older Adults in Randomized Controlled Trials
Zulman, D. M., Sussman, J. B., Chen, X., Cigolle, C. T., Blaum, C. S., & Hayward, R. A. (2011) · Journal of General Internal Medicine · doi:10.1007/s11606-010-1629-x · Cited by 392 · see citing works
Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial
Stone, G. W., White, H. D., Ohman, E. M., Bertrand, M. E., Lincoff, A. M., McLaurin, B. T., Cox, D. A., Pocock, S., Ware, J. H., Feit, F., et al. (2007) · The Lancet · doi:10.1016/s0140-6736(07)60450-4 · Cited by 388 · see citing works
Routine Upstream Initiation vs Deferred Selective Use of Glycoprotein IIb/IIIa Inhibitors in Acute Coronary Syndromes
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Trial and Error
Kaul, S., & Diamond, G. A. (2010) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2009.06.065 · Cited by 268 · see citing works
Antithrombotic Strategies in Patients With Acute Coronary Syndromes Undergoing Early Invasive Management
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Randomized Comparison of Everolimus- and Paclitaxel-Eluting Stents
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Evidence for the Selective Reporting of Analyses and Discrepancies in Clinical Trials: A Systematic Review of Cohort Studies of Clinical Trials
Dwan, K., Altman, D. G., Clarke, M., Gamble, C., Higgins, J. P. T., Sterne, J. A. C., Williamson, P. R., & Kirkham, J. J. (2014) · PLoS Medicine · doi:10.1371/journal.pmed.1001666 · Cited by 187 · see citing works
The Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement: Explanation and Elaboration
Kent, D. M., Klaveren, D. V., Paulus, J. K., D’Agostino, R. B., Goodman, S. N., Hayward, R. A., Ioannidis, J. P. A., Patrick‐Lake, B., Morton, S. C., Pencina, M. J., et al. (2019) · Annals of Internal Medicine · doi:10.7326/m18-3668 · Cited by 177 · see citing works
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A tutorial on methodological studies: the what, when, how and why
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Damned if you do, damned if you don't: subgroup analysis and equity
Petticrew, M. P., Tugwell, P., Kristjansson, E., Oliver, S. R., Ueffing, E., & Welch, V. A. (2011) · Journal of Epidemiology & Community Health · doi:10.1136/jech.2010.121095 · Cited by 150 · see citing works
Evaluation of Evidence of Statistical Support and Corroboration of Subgroup Claims in Randomized Clinical Trials
Wallach, J. D., Sullivan, P. G., Trepanowski, J. F., Sainani, K. L., Steyerberg, E. W., & Ioannidis, J. P. A. (2017) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2016.9125 · Cited by 148 · see citing works
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Brankovic, M., Kardys, I., Steyerberg, E. W., Lemeshow, S., Markovic, M., Rizopoulos, D., & Boersma, E. (2019) · European Journal of Clinical Investigation · doi:10.1111/eci.13145 · Cited by 130 · see citing works
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Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 4: Observational Studies
Manchikanti, L. (2009) · Pain Physician · doi:10.36076/ppj.2009/12/73 · Cited by 117 · see citing works
Dealing with heterogeneity of treatment effects: is the literature up to the challenge?
Gabler, N. B., Duan, N., Liao, D., Elmore, J. G., Ganiats, T. G., & Kravitz, R. L. (2009) · Trials · doi:10.1186/1745-6215-10-43 · Cited by 111 · see citing works
The proposed ‘concordance-statistic for benefit’ provided a useful metric when modeling heterogeneous treatment effects
Klaveren, D. V., Steyerberg, E. W., Serruys, P. W. J. C., & Kent, D. M. (2017) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.10.021 · Cited by 111 · see citing works
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Perspective: Limiting Dependence on Nonrandomized Studies and Improving Randomized Trials in Human Nutrition Research: Why and How
Trepanowski, J. F., & Ioannidis, J. P. A. (2018) · Advances in Nutrition · doi:10.1093/advances/nmy014 · Cited by 106 · see citing works
Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications
Kasenda, B., Schandelmaier, S., Sun, X., von Elm, E. B., You, J., Blümle, A., Tomonaga, Y., Saccilotto, R. T., Amstutz, A., Bengough, T., et al. (2014) · BMJ · doi:10.1136/bmj.g4539 · Cited by 102 · see citing works
Reading First Impact Study Final Report
Gamse, B., Jacob, R. T., Horst, M. A., Boulay, B. A., Associates, A., Unlu, F., Bozzi, L., Caswell, L., Rodger, C., Carter, W., et al. (2009) · Cited by 101 · see citing works
The influence of study characteristics on reporting of subgroup analyses in randomised controlled trials: systematic review
Sun, X., Briel, M., Busse, J. W., You, J. J., Akl, E. A., Mejza, F., Bała, M. M., Bassler, D., Mertz, D., Diaz-Granados, N., et al. (2011) · BMJ · doi:10.1136/bmj.d1569 · Cited by 98 · see citing works
The REFLECT Statement: Reporting guidelines for randomized controlled trials in livestock and food safety: Explanation and Elaboration
Sargeant, J. M., O’connor, A. M., Gardner, I. A., Dickson, J. S., Torrence, M. E., Dohoo, C. M. P. I. R., Lefebvre, S. L., Morley, P. S., Ramirez, A., & Snedeker, K. (2010) · Journal of Food Protection · doi:10.4315/0362-028x-73.3.579 · Cited by 97 · see citing works
The REFLECT Statement: Reporting Guidelines for Randomized Controlled Trials in Livestock and Food Safety: Explanation and Elaboration
Sargeant, J. M., O'Connor, A. M. C., Gardner, I. A., Dickson, J. S., Torrence, M. E., participants, C. M., Dohoo, I. R., Lefebvre, S. L., Morley, P. S., Ramirez, A., et al. (2010) · Zoonoses and Public Health · doi:10.1111/j.1863-2378.2009.01312.x · Cited by 95 · see citing works
Subgroup analyses in confirmatory clinical trials: time to be specific about their purposes
Tanniou, J., van der Tweel, I., Teerenstra, S., & Roes, K. C. B. (2016) · BMC Medical Research Methodology · doi:10.1186/s12874-016-0122-6 · Cited by 89 · see citing works
Sex based subgroup differences in randomized controlled trials: empirical evidence from Cochrane meta-analyses
Wallach, J. D., Sullivan, P. G., Trepanowski, J. F., Steyerberg, E. W., & Ioannidis, J. P. A. (2016) · BMJ · doi:10.1136/bmj.i5826 · Cited by 89 · see citing works
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Randomized trials published in higher vs. lower impact journals differ in design, conduct, and analysis
Bała, M. M., Akl, E. A., Sun, X., Bassler, D., Mertz, D., Mejza, F., Vandvik, P. O., Málaga, G., Johnston, B. C., Dahm, P., et al. (2013) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2012.10.005 · Cited by 83 · see citing works
Impact of Chronic Kidney Disease on Early (30-Day) and Late (1-Year) Outcomes of Patients With Acute Coronary Syndromes Treated With Alternative Antithrombotic Treatment Strategies
Mehran, R., Nikolsky, E., Lansky, A. J., Kirtane, A. J., Kim, Y., Feit, F., Manoukian, S. V., Moses, J. W., Ebrahimi, R., Ohman, E. M., et al. (2009) · JACC: Cardiovascular Interventions · doi:10.1016/j.jcin.2009.05.018 · Cited by 77 · see citing works
Baseline Matters: The Importance of Covariation for Baseline Severity in the Analysis of Clinical Trials
Nunes, E. V., Pavlicová, M., Hu, M., Campbell, A. N. C., Miele, G. M., Hien, D. A., & Klein, D. F. (2011) · The American Journal of Drug and Alcohol Abuse · doi:10.3109/00952990.2011.596980 · Cited by 64 · see citing works
Subgroup Analysis of Trials Is Rarely Easy (SATIRE): a study protocol for a systematic review to characterize the analysis, reporting, and claim of subgroup effects in randomized trials
Sun, X., Briel, M., Busse, J. W., Akl, E. A., You, J. J., Mejza, F., Bała, M. M., Diaz-Granados, N., Bassler, D., Mertz, D., et al. (2009) · Trials · doi:10.1186/1745-6215-10-101 · Cited by 60 · see citing works
Publicación de ensayos clínicos en revistas científicas: consideraciones editoriales
Alfonso, F., Segovia, J., Heras, M., & Bermejo, J. (2006) · Revista Española de Cardiología · doi:10.1157/13095794 · Cited by 56 · see citing works
Publication of Clinical Trials in Scientific Journals: Editorial Issves
Alfonso, F., Segovia, J., Heras, M., & Bermejo, J. (2006) · Revista Española de Cardiología (English Edition) · doi:10.1016/s1885-5857(07)60074-7 · Cited by 51 · see citing works
Estimates of absolute treatment benefit for individual patients required careful modeling of statistical interactions
Klaveren, D. V., Vergouwe, Y., Farooq, V., Serruys, P. W. J. C., & Steyerberg, E. W. (2015) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2015.02.012 · Cited by 47 · see citing works
Self-citation
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Authors: Hernández, A. V., Boersma, E., Murray, G. D., Habbema, J. D. F., & Steyerberg, E. W.
Affiliations: Erasmus MC (NL)
University of Edinburgh (GB)
Corresponding author: Hernández, Adrián V.
ORCID: Hernández, Adrián V.
Boersma, Eric
Murray, Gordon D.
Steyerberg, Ewout W.
Venue: American Heart Journal
Publisher: Elsevier BV
Published: 2006-02
Volume: 151
Issue: 2
Pages: 257-264
ISSN: 0002-8703 (ISSN-L)
DOI: 10.1016/j.ahj.2005.04.020
OpenAlex: W1971141955
Cited by: 131
References: 99
Citations by year: 2026: 2 · 2025: 3 · 2024: 8 · 2023: 4 · 2022: 5 · 2021: 2 · 2020: 7 · 2019: 6 · 2018: 4 · 2017: 3 · 2016: 7 · 2015: 3 · 2014: 7 · 2013: 11 · 2012: 13
FWCI: 7.82
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: American Heart Journal (publishedVersion)
PubMed (publishedVersion)
EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
Keywords: subgroup analysis, cardiovascular clinical trials, interaction testing, trial reporting quality, CONSORT, sample size, treatment decision-making, publication bias
MeSH terms: Cardiovascular Diseases, Data Interpretation, Statistical, Decision Making, Humans, Randomized Controlled Trials as Topic, Treatment Outcome, Clinical Trials, Phase III as Topic, Sample Size

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Subgroup analyses in therapeutic cardiovascular clinical trials: Are most of them misleading?

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