Subgroup analysis in randomised controlled trials: importance, indications, and interpretation

Rothwell, Peter M

doi:10.1016/s0140-6736(05)17709-5

Cited by 942Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsAdvanced Causal Inference Techniques

Subgroup analysis in randomised controlled trials: importance, indications, and interpretation

Rothwell, Peter M·2005·The Lancet

DOI 10.1016/s0140-6736(05)17709-5

Open this paper in CoChat — free account

Abstract

Large pragmatic trials provide the most reliable data about the effects of treatments, but should be designed, analysed, and reported to enable the most effective use of treatments in routine practice. Subgroup analyses are important if there are potentially large differences between groups in the risk of a poor outcome with or without treatment, if there is potential heterogeneity of treatment effect in relation to pathophysiology, if there are practical questions about when to treat, or if there are doubts about benefit in specific groups, such as elderly people, which are leading to potentially inappropriate undertreatment. Analyses must be predefined, carefully justified, and limited to a few clinically important questions, and post-hoc observations should be treated with scepticism irrespective of their statistical significance. If important subgroup effects are anticipated, trials should either be powered to detect them reliably or pooled analyses of several trials should be undertaken. Formal rules for the planning, analysis, and reporting of subgroup analyses are proposed.

Integrity signals

Registry

Crossref · 10.1016/s0140-6736(05)17709-5

Cites

134 of 134 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

In RCTs, interaction analysis, if incorrectly tested or misinterpreted, may lead to unnecessary withholding of treatment, ineffective or even harmful treatment effects.
“Although interaction analysis in RCTs is usually stated as the secondary study objective, if incorrectly tested or misinterpreted, it may lead to unnecessary withholding of treatment, ineffective or even harmful treatment effects.”
From Understanding of interaction (subgroup) analysis in clinical trials (2019) · cites this paper as [2]

Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies
(2002) · The Lancet · doi:10.1016/s0140-6736(02)11911-8 · Cited by 10,266 · see citing works
MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20 536 high-risk individuals: a randomised placebocontrolled trial
(2002) · The Lancet · doi:10.1016/s0140-6736(02)09327-3 · Cited by 6,992 · see citing works
Inflammation, aspirin, and the risk of cardiovascular disease in apparently healthy men
Ridker, P. M., Cushman, M., Stampfer, M. J., Tracy, R. P., & Hennekens, C. H. (1997) · New England Journal of Medicine · doi:10.1056/nejm199704033361401 · Cited by 5,504 · see citing works
Incidence of Adverse Drug Reactions in Hospitalized Patients: A Meta-analysis of Prospective Studies
Lazarou, J., Pomeranz, B. H., & Corey, P. N. (1998) · JAMA · doi:10.1001/jama.279.15.1200 · Cited by 4,807 · see citing works
Collaborative overview of randomised trials of antiplatelet therapy Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients
Altman, R., Carreras, L., Díaz, R. S., Figueroa, E. B., Paolasso, E., Parodi, J. C., Cade, J. F., Donnan, G. A., Eadie, M. J., Gavaghan, T. P., et al. (1994) · BMJ · doi:10.1136/bmj.308.6921.81 · Cited by 4,198 · see citing works
The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
Altman, D. G., Schulz, K. F., Moher, D., Egger, M., Davidoff, F., Elbourne, D., Gøtzsche, P. C., Lang, T., & for the CONSORT Group (2001) · Annals of Internal Medicine · doi:10.7326/0003-4819-134-8-200104170-00012 · Cited by 3,835 · see citing works
Benefit of Carotid Endarterectomy in Patients with Symptomatic Moderate or Severe Stenosis
Barnett, H. J. M., Taylor, D. W., Eliasziw, M., Fox, A. J., Ferguson, G. G., Haynes, R. B., Rankin, R. N., Clagett, G. P., Hachinski, V., Sackett, D. L., et al. (1998) · New England Journal of Medicine · doi:10.1056/nejm199811123392002 · Cited by 3,596 · see citing works
Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST)
Farrell, B., Fraser, A., Sandercock, P., Slattery, J., & Warlow, C. (1998) · The Lancet · doi:10.1016/s0140-6736(97)09292-1 · Cited by 3,356 · see citing works
COLLABORATIVE OVERVIEW OF RANDOMIZED TRIALS OF ANTIPLATELET THERAPY .1. PREVENTION OF DEATH, MYOCARDIAL-INFARCTION, AND STROKE BY PROLONGED ANTIPLATELET THERAPY IN VARIOUS CATEGORIES OF PATIENTS
Altman, R., Carreras, L., Díaz, R. S., Figueroa, E. B., Paolasso, E., Parodi, J. C., Cade, J. F., Donnan, G. A., Eadie, M. J., Gavaghan, T. P., et al. (1994) · Cited by 3,322 · see citing works
The TIMI Risk Score for Unstable Angina/Non–ST Elevation MI
Antman, E. M., Cohen, M. C., Bernink, P. J. L. M., McCabe, C. H., Horacek, T., Papuchis, G., Mautner, B., Corbalán, R., Radley, D. R., & Braunwald, E. (2000) · JAMA · doi:10.1001/jama.284.7.835 · Cited by 3,221 · see citing works
Beta blockade during and after myocardial infarction: An overview of the randomized trials
Yusuf, S., Peto, R., Lewis, J., Collins, R., & Sleight, P. (1985) · Progress in Cardiovascular Diseases · doi:10.1016/s0033-0620(85)80003-7 · Cited by 3,205 · see citing works
Randomised trial of a perindopril-based blood-pressure-lowering regimen among 6105 individuals with previous stroke or transient ischaemic attack
(2001) · The Lancet · doi:10.1016/s0140-6736(01)06178-5 · Cited by 3,178 · see citing works
The Efficacy of Azidothymidine (AZT) in the Treatment of Patients with AIDS and AIDS-Related Complex
Fischl, M. A., Richman, D. D., Grieco, M. H., Gottlieb, M. S., Volberding, P. A., Laskin, O. L., Leedom, J. M., Groopman, J. E., Mildvan, D., Schooley, R. T., et al. (1987) · New England Journal of Medicine · doi:10.1056/nejm198707233170401 · Cited by 2,995 · see citing works
Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. ISIS-2 (Second International Study of Infarct Survival) Collaborative Group.
Sleight, R. B., Sleight, P., Parish, S., Appleby, P. N., Collins, R., & Baigent, C. (1988) · PubMed · Cited by 2,868 · see citing works
急性心筋梗塞の疑いのある17187症例におけるストレプトキナーゼ静脈内投与,アスピリン経口投与,上記2つの併用または無処置の無作偽試験 ISIS-2
Dienstl, F., Backer, G. D., Cairns, J., Pedersen, F., Kala, R., Boissel, J., Schroeder, R., Horgan, J., & Tognoni, G. (1988) · The Lancet · Cited by 2,754 · see citing works
Indications for fibrinolytic therapy in suspected acute myocardial infarction: collaborative overview of early mortality and major morbidity results from all randomised trials of more than 1000 patients
Fibrinolytic Therapy Trialists' (FTT) Collaborative Group (1994) · The Lancet · doi:10.1016/s0140-6736(94)91161-4 · Cited by 2,727 · see citing works
EFFECTIVENESS OF INTRAVENOUS THROMBOLYTIC TREATMENT IN ACUTE MYOCARDIAL INFARCTION
GRUPPOITALIANOPERLOSTUDIODELL (1986) · The Lancet · doi:10.1016/s0140-6736(86)92368-8 · Cited by 2,626 · see citing works
External validity of randomised controlled trials: “To whom do the results of this trial apply?”
Rothwell, P. M. (2005) · The Lancet · doi:10.1016/s0140-6736(04)17670-8 · Cited by 2,544 · see citing works
Self-citation
Effect of coronary artery bypass graft surgery on survival: overview of 10-year results from randomised trials by the Coronary Artery Bypass Graft Surgery Trialists Collaboration
Yusuf, S., Zucker, D. M., Passamani, E. R., Peduzzi, P. N., Takaro, T., Fisher, L. D., Kennedy, J. W., Davis, K. B., Killip, T., Norris, R. M., et al. (1994) · The Lancet · doi:10.1016/s0140-6736(94)91963-1 · Cited by 2,129 · see citing works
Risk Factors for Stroke and Efficacy of Antithrombotic Therapy in Atrial Fibrillation
(1994) · Archives of Internal Medicine · doi:10.1001/archinte.1994.00420130036007 · Cited by 2,066 · see citing works
The Future of Data Analysis
Tukey, J. W. (1962) · The Annals of Mathematical Statistics · doi:10.1214/aoms/1177704711 · Cited by 1,934 · see citing works
The International Stroke Trial (IST): a randomised trial of aspirin, subcutaneous heparin, both, or neither among 19 435 patients with acute ischaemic stroke
(1997) · The Lancet · doi:10.1016/s0140-6736(97)04011-7 · Cited by 1,899 · see citing works
Unruptured Intracranial Aneurysms — Risk of Rupture and Risks of Surgical Intervention
The International Study of Unruptured Intracranial Aneurysms Investigators (1998) · New England Journal of Medicine · doi:10.1056/nejm199812103392401 · Cited by 1,889 · see citing works
ISIS-4: A randomised factorial trial assessing early oral captopril, oral mononitrate, and intravenous magnesium sulphate in 58 050 patients with suspected acute myocardial infarction
Collins, R. T., Peto, R., Flather, M., Parish, S., Sleight, P., Conway, M., Pipilis, A., Baigent, C., Barnett, D., Jp, B., et al. (1995) · The Lancet · doi:10.1016/s0140-6736(95)90865-x · Cited by 1,882 · see citing works
AHA Guidelines for Primary Prevention of Cardiovascular Disease and Stroke: 2002 Update
Pearson, T. A., Blair, S. N., Daniels, S. R., Eckel, R. H., Fair, J. M., Fortmann, S. P., Franklin, B. A., Goldstein, L. B., Greenland, P., Grundy, S. M., et al. (2002) · Circulation · doi:10.1161/01.cir.0000020190.45892.75 · Cited by 1,852 · see citing works
Analysis of pooled data from the randomised controlled trials of endarterectomy for symptomatic carotid stenosis
Rothwell, P. M., Eliasziw, M., Gutnikov, S., Fox, A. J., Taylor, D., Mayberg, M. R., Warlow, C. P., & Barnett, H. J. M. (2003) · The Lancet · doi:10.1016/s0140-6736(03)12228-3 · Cited by 1,669 · see citing works
Self-citation
Oxford Textbook of Medicine.
(1988) · Annals of Internal Medicine · doi:10.7326/0003-4819-108-3-499_7 · Cited by 1,583 · see citing works
Long-term ACE-inhibitor therapy in patients with heart failure or left-ventricular dysfunction: a systematic overview of data from individual patients
Flather, M. D., Yusuf, S., Køber, L., Pfeffer, M. A., Hall, A. S., Murray, G. D., Torp-Pedersen, C. T., Ball, S. G., Pogue, J. M., Moyé, L. A., et al. (2000) · The Lancet · doi:10.1016/s0140-6736(00)02212-1 · Cited by 1,580 · see citing works
West of Scotland Coronary Prevention Study: identification of high-risk groups and comparison with other cardiovascular intervention trials
(1996) · The Lancet · doi:10.1016/s0140-6736(96)04292-4 · Cited by 1,564 · see citing works
Endarterectomy for symptomatic carotid stenosis in relation to clinical subgroups and timing of surgery
Rothwell, P. M., Eliasziw, M., Gutnikov, S., Warlow, C., & Barnett, H. J. M. (2004) · The Lancet · doi:10.1016/s0140-6736(04)15785-1 · Cited by 1,546 · see citing works
Self-citation
MRC trial of treatment of mild hypertension: principal results. Medical Research Council Working Party.
(1985) · BMJ · doi:10.1136/bmj.291.6488.97 · Cited by 1,491 · see citing works
A Comparison of Low-Molecular-Weight Heparin with Unfractionated Heparin for Unstable Coronary Artery Disease
Cohen, M., Demers, C., Gurfinkel, E., Turpie, A. G. G., Fromell, G. J., Goodman, S. G., Langer, A., Califf, R. M., Fox, K. A. A., Premmereur, J., et al. (1997) · New England Journal of Medicine · doi:10.1056/nejm199708143370702 · Cited by 1,406 · see citing works
A Randomized Trial of Propranolol in Patients With Acute Myocardial Infarction
(1982) · JAMA · doi:10.1001/jama.1982.03320370021023 · Cited by 1,376 · see citing works
A double‐blind, placebo‐controlled trial
Pinals, R. S., Kaplan, S. B., Lawson, J. G., & Hepburn, B. (1986) · Arthritis & Rheumatism · doi:10.1002/art.1780291202 · Cited by 1,355 · see citing works
Effect of Amlodipine on Morbidity and Mortality in Severe Chronic Heart Failure
Packer, M., O’Connor, C. M., Ghali, J. K., Pressler, M. L., Carson, P. E., Belkin, R. N., Miller, A. B., Neuberg, G. W., Frid, D. J., WERTHEIMER, J. H., et al. (1996) · New England Journal of Medicine · doi:10.1056/nejm199610103351504 · Cited by 1,194 · see citing works
Subgroup analysis and other (mis)uses of baseline data in clinical trials
Assmann, S. F., Pocock, S. J., Enos, L. E., & Kasten, L. E. (2000) · The Lancet · doi:10.1016/s0140-6736(00)02039-0 · Cited by 1,167 · see citing works
ISIS-4 - A randomised factorial assessing early oral captopril, oral mononitrate, and intravenous magnesium sulphate in 58.050 patient with suspected acute myocardial-infarction.
Collins, R. T., Peto, R., Flather, M. D., Parish, S., Sleight, P., Conway, M. A., Pipilis, A., Baigent, C., Barnett, D., Boissel, J., et al. (1995) · Ghent University Academic Bibliography (Ghent University) · Cited by 1,115 · see citing works
Inheritance and Drug Response
Weinshilboum, R. M. (2003) · New England Journal of Medicine · doi:10.1056/nejmra020021 · Cited by 1,032 · see citing works
Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials
Yusuf, S. (1991) · JAMA: The Journal of the American Medical Association · doi:10.1001/jama.1991.03470010097038 · Cited by 1,014 · see citing works
A Randomized Trial of Aspirin and Sulfinpyrazone in Threatened Stroke
The Canadian Cooperative Study Group (1978) · New England Journal of Medicine · doi:10.1056/nejm197807132990201 · Cited by 960 · see citing works
Effects of Adjuvant Tamoxifen and of Cytotoxic Therapy on Mortality in Early Breast Cancer
Early Breast Cancer Trialists' Collaborative Group (1988) · New England Journal of Medicine · doi:10.1056/nejm198812293192601 · Cited by 934 · see citing works
A consumer's guide to subgroup analyses
Oxman, A. D., & Guyatt, G. H. (1992) · Annals of Internal Medicine · doi:10.7326/0003-4819-116-1-78 · Cited by 914 · see citing works
Gene expression profiling for the prediction of therapeutic response to docetaxel in patients with breast cancer
Chang, J. C., Wooten, E. C., Tsimelzon, A. I., Hilsenbeck, S. G., Gutierrez, M. C., Elledge, R. M., Mohsin, S. K., Osborne, C. K., Chamness, G. C., Allred, D. C., et al. (2003) · The Lancet · doi:10.1016/s0140-6736(03)14023-8 · Cited by 875 · see citing works
Postoperative radiotherapy in non-small-cell lung cancer: systematic review and meta-analysis of individual patient data from nine randomised controlled trials
Burdett, S., Parmar, M., Stewart, L. A., Souhami, R. L., Arriagada, R., Girling, D., Pignon, J., Torri, V., Brichet, A., Lafitte, J. J., et al. (1998) · The Lancet · doi:10.1016/s0140-6736(98)06341-7 · Cited by 837 · see citing works
The Effect of Diltiazem on Mortality and Reinfarction after Myocardial Infarction
The Multicenter Diltiazem Postinfarction Trial Research Group (1988) · New England Journal of Medicine · doi:10.1056/nejm198808183190701 · Cited by 823 · see citing works
Importance of Hemodynamic Factors in the Prognosis of Symptomatic Carotid Occlusion
Grubb, R. L. (1998) · JAMA · doi:10.1001/jama.280.12.1055 · Cited by 804 · see citing works
Genetic Control of Isoniazid Metabolism in Man
Evans, D. A. P., Manley, K. A., & McKusick, V. A. (1960) · BMJ · doi:10.1136/bmj.2.5197.485 · Cited by 789 · see citing works
Population based study of early risk of stroke after transient ischaemic attack or minor stroke: implications for public education and organisation of services
Coull, A. J., Lovett, J. K., & Rothwell, P. M. (2004) · BMJ · doi:10.1136/bmj.37991.635266.44 · Cited by 775 · see citing works
Self-citation
Early risk of recurrence by subtype of ischemic stroke in population-based incidence studies
Lovett, J. K., Coull, A. J., & Rothwell, P. M. (2004) · Neurology · doi:10.1212/01.wnl.0000110311.09970.83 · Cited by 736 · see citing works
Self-citation
Potential Role of Pharmacogenomics in Reducing Adverse Drug Reactions
Phillips, K. A., Veenstra, D. L., Oren, E., Lee, J. K., & Sadée, W. (2001) · JAMA · doi:10.1001/jama.286.18.2270 · Cited by 705 · see citing works
Why do we need some large, simple randomized trials?
Yusuf, S., Collins, R., & Peto, R. (1984) · Statistics in Medicine · doi:10.1002/sim.4780030421 · Cited by 700 · see citing works
Statistical Problems in the Reporting of Clinical Trials
Pocock, S., Hughes, M. D., & Lee, R. J. (1987) · New England Journal of Medicine · doi:10.1056/nejm198708133170706 · Cited by 660 · see citing works
Guidelines for Carotid Endarterectomy
Biller, J., Feinberg, W. M., Castaldo, J., Whittemore, A. D., Harbaugh, R. E., Dempsey, R. J., Caplan, L. R., Kresowik, T. F., Matchar, D. B., Toole, J. F., et al. (1998) · Stroke · doi:10.1161/01.str.29.2.554 · Cited by 660 · see citing works
Problems in the “Evidence” of “Evidence-Based Medicine”
Feinstein, A. R., & Horwitz, R. I. (1997) · The American Journal of Medicine · doi:10.1016/s0002-9343(97)00244-1 · Cited by 653 · see citing works
Summing up evidence: one answer is not always enough
Lau, J., Ioannidis, J. P. A., & Schmid, C. H. (1998) · The Lancet · doi:10.1016/s0140-6736(97)08468-7 · Cited by 646 · see citing works
Controlled trial of aspirin in cerebral ischemia.
Fields, W. S., Lemak, N. A., Frankowski, R. F., & Hardy, R. J. (1977) · Stroke · doi:10.1161/01.str.8.3.301 · Cited by 631 · see citing works
Antihypertensive drugs in very old people: a subgroup meta-analysis of randomised controlled trials
Gueyffier, F., Bulpitt, C. J., Boissel, J., SCHRON, E. B., Ekbom, T., Fagard, R. H., Casiglia, E., Kerlikowske, K. M., & Coope, J. (1999) · The Lancet · doi:10.1016/s0140-6736(98)08127-6 · Cited by 628 · see citing works
National Clinical Guidelines for Stroke.
Robinson, T. G. (2001) · Postgraduate Medical Journal · doi:10.1136/pmj.77.906.286h · Cited by 608 · see citing works
Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives
Brookes, S. T., Whitley, E., Peters, T. J., Mulheran, P. A., Egger, M., & Davey Smith, G. (2001) · Health Technology Assessment · doi:10.3310/hta5330 · Cited by 580 · see citing works
Low-dose and high-dose acetylsalicylic acid for patients undergoing carotid endarterectomy: a randomised controlled trial
Taylor, D. W., Barnett, H. J., Haynes, R. B., Ferguson, G. G., Sackett, D. L., Thorpe, K. E., Simard, D., Silver, F. L., Hachinski, V., Clagett, G. P., et al. (1999) · The Lancet · doi:10.1016/s0140-6736(99)05388-x · Cited by 530 · see citing works
The effect of diltiazem on mortality and reinfarction after myocardial infarction
Warnock, E. W. (1989) · Journal of Emergency Medicine · doi:10.1016/0736-4679(89)90390-9 · Cited by 508 · see citing works
The VA cooperative randomized study of surgery for coronary arterial occlusive disease II. Subgroup with significant left main lesions.
Takaro, T., Hultgren, H. N., Lipton, M. J., & Detre, K. M. (1976) · PubMed · Cited by 491 · see citing works
Concorde: MRC/ANRS randomised double-blind controlled trial of immediate and deferred zidovudine in symptom-free HIV infection
SELIGMANN, M., WARRELL, D., ABOULKER, J., CARBON, C., DARBYSHIRE, J., DORMONT, J., ESCHWEGE, E., GIRLING, D., JAMES, D., LEVY, J., et al. (1994) · The Lancet · doi:10.1016/s0140-6736(94)90006-x · Cited by 489 · see citing works
Randomised trial of home-based psychosocial nursing intervention for patients recovering from myocardial infarction
Frasure-Smith, N., Lespérance, F., Prince, R. H., Verrier, P., Garber, R. A., Juneau, M., Wolfson, C., & Bourassa, M. G. (1997) · The Lancet · doi:10.1016/s0140-6736(97)02142-9 · Cited by 461 · see citing works
Inpatient general medicine is evidence based
Sackett, D. L., Ellis, J., Mulligan, I., & Rowe, J. B. (1995) · The Lancet · doi:10.1016/s0140-6736(95)92781-6 · Cited by 433 · see citing works
Prediction of benefit from carotid endar terectomy in individual patients: a risk-modelling study
Rothwell, P. M., & Warlow, C. P. (1999) · The Lancet · doi:10.1016/s0140-6736(98)11415-0 · Cited by 409 · see citing works
Self-citation
Aspirin for primary prevention of coronary heart disease: safety and absolute benefit related to coronary risk derived from meta-analysis of randomised trials
Sanmuganathan, P. S., Ghahramani, P., Jackson, P. R., Wallis, E. J., & Ramsay, L. E. (2001) · Heart · doi:10.1136/heart.85.3.265 · Cited by 409 · see citing works
The TIMI risk score for unstable angina/non–ST-elevation MI: a method for prognostication and therapeutic decision making
Antman, E. M., Cohen, M. C., & Bernink, P. J. L. M. (2001) · ACC Current Journal Review · doi:10.1016/s1062-1458(00)00159-8 · Cited by 401 · see citing works
Effect of Pravastatin on Coronary Disease Events in Subgroups Defined by Coronary Risk Factors: The Prospective Pravastatin Pooling Project
Sacks, F. M., Tonkin, A. M., Shepherd, J., Braunwald, E., Cobbe, S., Hawkins, C. M., Keech, A., Packard, C., Simes, J., Byington, R., et al. (2000) · Circulation · doi:10.1161/01.cir.102.16.1893 · Cited by 388 · see citing works
Estrogen-Receptor Polymorphisms and Effects of Estrogen Replacement on High-Density Lipoprotein Cholesterol in Women with Coronary Disease
Herrington, D. M., Howard, T. D., Hawkins, G. A., Reboussin, D. M., Xu, J., Zheng, S. L., Brosnihan, K. B., Meyers, D. A., & Bleecker, E. R. (2002) · New England Journal of Medicine · doi:10.1056/nejmoa012952 · Cited by 372 · see citing works
Effect of Antihypertensive Drug Treatment on Cardiovascular Outcomes in Women and Men
Gueyffier, F., Boutitie, F., Boissel, J., Pocock, S., Coope, J., Cutler, J., Ekbom, T., Fagard, R., Friedman, L., Perry, M., et al. (1997) · Annals of Internal Medicine · doi:10.7326/0003-4819-126-10-199705150-00002 · Cited by 353 · see citing works
Reliable assessment of the effects of treatment on mortality and major morbidity, I: clinical trials
Collins, R., & MacMahon, S. W. (2001) · The Lancet · doi:10.1016/s0140-6736(00)03651-5 · Cited by 337 · see citing works
Finding and Applying Evidence During Clinical Rounds The "Evidence Cart"
Sackett, D. L. (1998) · JAMA · doi:10.1001/jama.280.15.1336 · Cited by 335 · see citing works
Prevention of First Bleeding in Cirrhosis
Pagliaro, L., D’Amico, G., Sørensen, T. I. A., Lebrec, D., Burroughs, A. K., Morabito, A., Tinè, F., Politi, F., & Traina, M. (1992) · Annals of Internal Medicine · doi:10.7326/0003-4819-117-1-59 · Cited by 318 · see citing works
Can overall results of clinical trials be applied to all patients?
Rothwell, P. M. (1995) · The Lancet · doi:10.1016/s0140-6736(95)90120-5 · Cited by 314 · see citing works
Self-citation
Systematic review of evidence on thrombolytic therapy for acute ischaemic stroke
Wardlaw, J. M., Warlow, C. P., & Counsell, C. E. (1997) · The Lancet · doi:10.1016/s0140-6736(97)03022-5 · Cited by 287 · see citing works
Systematic Review of the Risks of Carotid Endarterectomy in Relation to the Clinical Indication for and Timing of Surgery
Bond, R. C., Rerkasem, K., & Rothwell, P. M. (2003) · Stroke · doi:10.1161/01.str.0000087785.01407.cc · Cited by 273 · see citing works
Self-citation
Thrombolysis in acute ischemic stroke: controlled trials and clinical experience.
Hacke, W., Brott, T. G., Caplan, L. R., Meier, D., Fieschi, C., von Kummer, R., Donnan, G. A., Wd, H., Wahlgren, N. G., Spranger, M., et al. (1999) · PubMed · Cited by 240 · see citing works
Relationship Between Blood Pressure and Stroke Risk in Patients With Symptomatic Carotid Occlusive Disease
Rothwell, P. M., Howard, S. C., & Spence, J. D. (2003) · Stroke · doi:10.1161/01.str.0000094424.38761.56 · Cited by 232 · see citing works
Self-citation
Benefit of Clopidogrel in Patients With Acute Coronary Syndromes Without ST-Segment Elevation in Various Risk Groups
Budaj, A., Yusuf, S., Mehta, S. R., Fox, K. A. A., Tognoni, G., Zhao, F., Chrolavicius, S., Hunt, D., Keltai, M., & Franzosi, M. G. (2002) · Circulation · doi:10.1161/01.cir.0000029926.71825.e2 · Cited by 228 · see citing works
EFFECT OF ALPRENOLOL ON MORTALITY AMONG PATIENTS WITH DEFINITE OR SUSPECTED ACUTE MYOCARDIAL INFARCTION
Andersen, M., Frederiksen, J., Hj, J., Pedersen, F., Bechsgaard, P., Hansen, D. D., Nielsen, B. L., Pedersen-Bjergaard, O., & Rasmussen, S. (1979) · The Lancet · doi:10.1016/s0140-6736(79)92684-9 · Cited by 227 · see citing works
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: sub-group analysis on entry stratification.
Amery, A., Birkenhäger, W. H., Brixko, P., Bulpitt, C. J., Clément, D., de Leeuw, P. W., Jf, D. P., Deruyttere, M., SCHAEPDRYVER, A. D., & Dollery, C. T. (1986) · PubMed · Cited by 198 · see citing works
DNA markers predicting benefit from adjuvant fluorouracil in patients with colon cancer: a molecular study
Barratt, P., Seymour, M., Stenning, S. P., Georgiades, I. B., Walker, C., Birbeck, K. F., & Quirke, P. (2002) · The Lancet · doi:10.1016/s0140-6736(02)11402-4 · Cited by 194 · see citing works
Can randomised trials inform clinical decisions about individual patients?
Mant, D. (1999) · The Lancet · doi:10.1016/s0140-6736(98)09102-8 · Cited by 193 · see citing works
A Systematic Comparison of the Risks of Stroke and Death Due to Carotid Endarterectomy for Symptomatic and Asymptomatic Stenosis
Rothwell, P. M., Slattery, J., & Warlow, C. P. (1996) · Stroke · doi:10.1161/01.str.27.2.266 · Cited by 177 · see citing works
Self-citation
Meta-analysis. Beyond the grand mean?
Smith, G. D., Egger, M., & Phillips, A. N. (1997) · BMJ · doi:10.1136/bmj.315.7122.1610 · Cited by 174 · see citing works
SOME STATISTICAL DATA ON ATYPICAL CHOLINESTERASE OF HUMAN SERUM
KALOW, W., & Gunn, D. R. (1959) · Annals of Human Genetics · doi:10.1111/j.1469-1809.1959.tb01467.x · Cited by 163 · see citing works
Hypertension in Women: What is Really Known?
Anastos, K., Charney, P., Charon, R., Cohen, E., Jones, C. Y., Marte, C., Swiderski, D. M., Wheat, M. E., & Williams, S. (1991) · Annals of Internal Medicine · doi:10.7326/0003-4819-115-4-287 · Cited by 158 · see citing works
Reduction in mortality after myocardial infarction with long-term beta-adrenoceptor blockade. Multicentre international study: supplementary report.
(1977) · BMJ · doi:10.1136/bmj.2.6084.419 · Cited by 152 · see citing works
Effect of anti-lymphocyte induction therapy on renal allograft survival
Szczech, L. A. M., Berlin, J. A., Aradhye, S., GROSSMAN, R. A., & Feldman, H. I. (1997) · Journal of the American Society of Nephrology · doi:10.1681/asn.v8111771 · Cited by 142 · see citing works
Is aspirin safe for patients with heart failure?
Cleland, J. G. F., Bulpitt, C. J., Falk, R. H., et al. (1995) · Heart · doi:10.1136/hrt.74.3.215 · Cited by 132 · see citing works
The Effect of Antilymphocyte Induction Therapy on Renal Allograft Survival
Szczech, L. A. M., Berlin, J. A., & Feldman, H. I. (1998) · Annals of Internal Medicine · doi:10.7326/0003-4819-128-10-199805150-00004 · Cited by 129 · see citing works
Treatment of Chlamydia pneumoniae infection with roxithromycin and effect on neointima proliferation after coronary stent placement (ISAR-3): a randomised, double-blind, placebo-controlled trial
Neumann, F., Kastrati, A., Miethke, T., et al. (2001) · The Lancet · doi:10.1016/s0140-6736(00)05181-3 · Cited by 125 · see citing works
Unruptured intracranial aneurysm-risk of rupture and risks of surgical intervention.
Martin, D. (2000) · Open Repository and Bibliography (University of Liège) · Cited by 118 · see citing works
Evidence in consultations: interpreted and individualised
Sullivan, F., & Macnaughton, R. J. (1996) · The Lancet · doi:10.1016/s0140-6736(96)05219-1 · Cited by 115 · see citing works
Evidence-based and Evidence-biased Medicine
EVANS, J. G. (1995) · Age and Ageing · doi:10.1093/ageing/24.6.461 · Cited by 109 · see citing works
The impact of high-risk patients on the results of clinical trials
Ioannidis, J. P. A., & Lau, J. (1997) · Journal of Clinical Epidemiology · doi:10.1016/s0895-4356(97)00149-2 · Cited by 108 · see citing works
Prevention of pulmonary embolism.
Ruckley, C. V., MacIntyre, I. M., Jones, D. R. B., & Copland, W. A. (1973) · BMJ · doi:10.1136/bmj.2.5863.419 · Cited by 104 · see citing works
Quantitative analysis of the admission electrocardiogram identifies patients with unstable coronary artery disease who benefit the most from early invasive treatment
Holmvang, L., Clemmensen, P., Lindahl, B., et al. (2003) · Journal of the American College of Cardiology · doi:10.1016/s0735-1097(02)02970-4 · Cited by 103 · see citing works
False-Positive Results in Clinical Trials: Multiple Significance Tests and the Problem of Unreported Comparisons
Tannock, I. F. (1996) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/88.3-4.206 · Cited by 92 · see citing works
Estimation issues in clinical trials and overviews
Pocock, S., & Hughes, M. D. (1990) · Statistics in Medicine · doi:10.1002/sim.4780090612 · Cited by 88 · see citing works
Evidence based medicine: concerns of a clinical neurologist
Caplan, L. R. (2001) · Journal of Neurology Neurosurgery & Psychiatry · doi:10.1136/jnnp.71.5.569 · Cited by 88 · see citing works
Generalizing the results of randomized clinical trials
Bailey, K. R. (1994) · Controlled Clinical Trials · doi:10.1016/0197-2456(94)90024-8 · Cited by 87 · see citing works
The Problem of Cogent Subgroups: A Clinicostatistical Tragedy
Feinstein, A. R. (1998) · Journal of Clinical Epidemiology · doi:10.1016/s0895-4356(98)00004-3 · Cited by 85 · see citing works
ISSUES RELATED TO SUBGROUP ANALYSIS IN CLINICAL TRIALS
Cui, L., Hung, H., Wang, S., & Tsong, Y. (2002) · Journal of Biopharmaceutical Statistics · doi:10.1081/bip-120014565 · Cited by 77 · see citing works
Cerebral Metabolism of Patients With Stenosis or Occlusion of the Internal Carotid Artery
van der Grond, J., Balm, R., Kappelle, L. J., et al. (1995) · Stroke · doi:10.1161/01.str.26.5.822 · Cited by 74 · see citing works
Applying overviews and meta-analyses at the bedside
Sackett, D. L. (1995) · Journal of Clinical Epidemiology · doi:10.1016/0895-4356(94)00085-5 · Cited by 61 · see citing works
The 2001 Canadian recommendations for the management of hypertension: Part two--Therapy.
McAlister, F. A., Zarnke, K. B., Campbell, N. R. C., et al. (2002) · PubMed · Cited by 61 · see citing works
An Effect Model for the Assessment of Drug Benefit
Boissel, J., Collet, J., Lièvre, M. M., & Girard, P. (1993) · Journal of Cardiovascular Pharmacology · doi:10.1097/00005344-199309000-00003 · Cited by 59 · see citing works
The limitations of evidence.
Black, D. A. K. (1998) · PubMed · Cited by 57 · see citing works
Controlled Trial of Aspirin in Cerebral Ischemia (AITIA Study)
Fields, W. S., Lemak, N. A., Frankowski, R. F., et al. (1979) · Thrombosis and Haemostasis · doi:10.1055/s-0039-1687188 · Cited by 56 · see citing works
The use and abuse of subgroup analysis in epidemiological research
Stallones, R. A. (1987) · Preventive Medicine · doi:10.1016/0091-7435(87)90082-x · Cited by 55 · see citing works
Applying the results of clinical trials to patients to general practice: perceived problems, strengths, assumptions, and challenges for the future.
Fahey, T. P. (1998) · PubMed Central · Cited by 47 · see citing works
Limitations of clinical diagnosis in acute stroke
Allder, S. J., Moody, A., Martel, A. L., Morgan, P. S., Delay, G. S., Gladman, J. R. F., Fentem, P. H., & Lennox, G. G. (1999) · The Lancet · doi:10.1016/s0140-6736(99)04360-3 · Cited by 46 · see citing works
What do subgroup analyses reveal about differential response to beta-blocker therapy? The Beta-Blocker Heart Attack Trial experience.
Cd, F., & Rp, B. (1983) · PubMed · Cited by 44 · see citing works
Problems in the medical interpretation of overviews
Wittes, R. E. (1987) · Statistics in Medicine · doi:10.1002/sim.4780060312 · Cited by 43 · see citing works
Evidence-based medicine and hypertension
Swales, J. D. (1999) · Journal of Hypertension · doi:10.1097/00004872-199917110-00002 · Cited by 43 · see citing works
High-Risk and Population Strategies of Prevention: Ethical Considerations
Rose, G. (1989) · Annals of Medicine · doi:10.3109/07853898909149231 · Cited by 42 · see citing works
Neurohormones and oxidative stress in nonischemic cardiomyopathy: relationship to survival and the effect of treatment with amlodipine
Wijeysundera, H. C., Hansen, M. S. T., Stanton, E. B., Cropp, A., Hall, C., Dhalla, N. S., Ghali, J. K., & Rouleau, J. L. (2003) · American Heart Journal · doi:10.1016/s0002-8703(03)00171-6 · Cited by 39 · see citing works
Individualising HIV treatment—pharmacogenetics and immunogenetics
Telenti, A., Aubert, V., & Spertini, F. (2002) · The Lancet · doi:10.1016/s0140-6736(02)07899-6 · Cited by 37 · see citing works
Interpretation of results from subset analyses within overviews of randomized clinical trials
Gelber, R. D., & Goldhirsch, A. (1987) · Statistics in Medicine · doi:10.1002/sim.4780060331 · Cited by 37 · see citing works
Applying results of randomised trials to patients: Authors' reply
Senn, S. J. (1998) · BMJ · doi:10.1136/bmj.317.7157.537 · Cited by 35 · see citing works
Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals
Moreira, E. D., STEIN, Z. A., & Susser, E. (2001) · Brazilian Journal of Medical and Biological Research · doi:10.1590/s0100-879x2001001100011 · Cited by 28 · see citing works
HYPERTENSION: Matching the right drug to the right patient in essential hypertension
Brown, M. J. (2001) · Heart · doi:10.1136/heart.86.1.113 · Cited by 25 · see citing works
Uncontrolled Pearls, Controlled Evidence, Meta-Analysis and the Individual Patient☆
Ioannidis, J. P. A. (1998) · Journal of Clinical Epidemiology · doi:10.1016/s0895-4356(98)00042-0 · Cited by 23 · see citing works
Size isn't everything
Hampton, J. R. (2002) · Statistics in Medicine · doi:10.1002/sim.1284 · Cited by 22 · see citing works
Concorde trial of immediate versus deferred zidovudine
Egger, M., Neaton, J. D., Phillips, A., Smith, G. D., Graham, N. H., Montaner, J. G., Raboud, J., O’Shaughnessy, M. V., Laing, P., Gore, S., et al. (1994) · The Lancet · doi:10.1016/s0140-6736(94)92490-2 · Cited by 18 · see citing works
National Clinical Guidelines for Stroke: a concise update
Stroke, T. I. W. P. F. (2002) · Clinical Medicine · doi:10.7861/clinmedicine.2-3-231 · Cited by 13 · see citing works
Identification and prediction of responders to a therapy: A model and its preliminary application to actual data
Wei, L. A.-P. B., Girard, P., Boutitie, F., et al. (1998) · Controlled Clinical Trials · doi:10.1016/s0197-2456(98)80125-6 · Cited by 7 · see citing works
A Patient's Attitude to the Use of Research Evidence for Guiding Individual Choices and Decisions in Healthcare
Chalmers, I. (2000) · Clinical Risk · doi:10.1177/135626220000600604 · Cited by 7 · see citing works
How best to analyse new strategies in bone marrow transplantation.
Rp, G., & Horowitz, M. M. (1990) · PubMed · Cited by 6 · see citing works
Extrapolation of Trials Data into Practice: Where Is the Limit?
van Gijn, J. (1995) · Cerebrovascular Diseases · doi:10.1159/000107844 · Cited by 4 · see citing works
[Identification and prediction of responders to a therapy. A model and its preliminary application to hypertension].
Li, W.-B., Gueyffier, F., Boissel, J. P., et al. (1998) · PubMed · Cited by 3 · see citing works
Assessing the potential for bias in meta-analysis due to selective reporting of subgroup analyses within studies
Hahn, S., Williamson, P. R., Hutton, J. L., Garner, P., & Flynn, E. V. (2000) · Statistics in Medicine · doi:10.1002/1097-0258(20001230)19:24

Flagged first, then by citations

Sorted by citations

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
Contribution of Primary Care to Health Systems and Health
STARFIELD, B., SHI, L., & MACINKO, J. (2005) · The Milbank Quarterly · doi:10.1111/j.1468-0009.2005.00409.x · Cited by 5,507 · 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
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
The role of aspirin dose on the prevention of preeclampsia and fetal growth restriction: systematic review and meta-analysis
Roberge, S., Nicolaides, K., Demers, S., Hyett, J., Chaillet, N., & Bujold, E. (2017) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2016.09.076 · Cited by 679 · see citing works
How to Use a Subgroup Analysis: Users’ Guide to the Medical Literature
Sun, X., Ioannidis, J. P. A., Agoritsas, T., Alba, A. C., & Guyatt, G. (2014) · JAMA · doi:10.1001/jama.2013.285063 · Cited by 550 · see citing works
The Use of Propensity Scores to Assess the Generalizability of Results from Randomized Trials
Stuart, E. A., Cole, S. R., Bradshaw, C. P., & Leaf, P. J. (2011) · Journal of the Royal Statistical Society Series A: Statistics in Society · doi:10.1111/j.1467-985x.2010.00673.x · Cited by 524 · 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
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
Multidomain lifestyle intervention benefits a large elderly population at risk for cognitive decline and dementia regardless of baseline characteristics: The FINGER trial
Rosenberg, A., Ngandu, T., Rusanen, M., Antikainen, R., Bäckman, L., Havulinna, S., Hänninen, T., Laatikainen, T., Lehtisalo, J., Levälahti, E., et al. (2018) · Alzheimer's & Dementia · doi:10.1016/j.jalz.2017.09.006 · Cited by 421 · see citing works
Observational research, randomised trials, and two views of medical science
Vandenbroucke, J. P. (2008) · PLoS Medicine · doi:10.1371/journal.pmed.0050067 · Cited by 416 · see citing works
Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF
Hankey, G. J., Patel, M. R., Stevens, S. R., Becker, R. C., Breithardt, G., Carolei, A., Diener, H.-C., Donnan, G. A., Halperin, J. L., Mahaffey, K. W., et al. (2012) · The Lancet Neurology · doi:10.1016/s1474-4422(12)70042-x · Cited by 354 · see citing works
Three simple rules to ensure reasonably credible subgroup analyses
Burke, J. F., Sussman, J. B., Kent, D. M., & Hayward, R. A. (2015) · BMJ · doi:10.1136/bmj.h5651 · Cited by 312 · see citing works
Tutorial in biostatistics: data‐driven subgroup identification and analysis in clinical trials
Lipkovich, I., Dmitrienko, A., & B., R. (2017) · Statistics in Medicine · doi:10.1002/sim.7064 · Cited by 291 · see citing works
Untitled work
Bogner (2007) · doi:10.2337/dc07-0974 · Cited by 209 · see citing works
Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols
Chan, A.-W., Hrobjartsson, A., Jorgensen, K. J., Gotzsche, P. C., & Altman, D. G. (2008) · BMJ · doi:10.1136/bmj.a2299 · Cited by 202 · see citing works
Micronized vaginal progesterone to prevent miscarriage: a critical evaluation of randomized evidence
Coomarasamy, A., Devall, A. J., Brosens, J. J., Quenby, S., Stephenson, M. D., Sierra, S., Christiansen, O. B., Small, R., Brewin, J., Roberts, T. E., et al. (2020) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2019.12.006 · Cited by 163 · see citing works
Circle of Security–Parenting: A randomized controlled trial in Head Start
Cassidy, J., Brett, B. E., Gross, J. T., Stern, J. A., Martin, D. R., Mohr, J. J., & Woodhouse, S. S. (2017) · Development and Psychopathology · doi:10.1017/s0954579417000244 · Cited by 167 · see citing works
A systematic review of predictors and moderators of response to psychological therapies in OCD: Do we have enough empirical evidence to target treatment?
Knopp, J., Knowles, S., Bee, P., Lovell, K., & Bower, P. (2013) · Clinical Psychology Review · doi:10.1016/j.cpr.2013.08.008 · Cited by 164 · see citing works
Methodological criteria for the assessment of moderators in systematic reviews of randomised controlled trials: a consensus study.
Pincus, T., Miles, C., Froud, R., Underwood, M., Carnes, D., & Taylor, S. J. (2011) · BMC Medical Research Methodology · doi:10.1186/1471-2288-11-14 · Cited by 161 · see citing works
Improving diabetes prevention with benefit based tailored treatment: risk based reanalysis of Diabetes Prevention Program
Sussman, J. B., Kent, D. M., Nelson, J. P., & Hayward, R. A. (2015) · BMJ · doi:10.1136/bmj.h454 · Cited by 143 · 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
Understanding of interaction (subgroup) analysis in clinical trials
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
Chronic absence, eighth-grade achievement, and high school attainment in the Chicago Longitudinal Study.
Smerillo, N. E., Reynolds, A. J., Temple, J. A., & Ou, S.-R. (2018) · Journal of School Psychology · doi:10.1016/j.jsp.2017.11.001 · Cited by 125 · see citing works
When One Depends on the Other: Reporting of Interaction in Case-Control and Cohort Studies
Knol, M. J., Egger, M., Scott, P., Geerlings, M. I., & Vandenbroucke, J. P. (2009) · Epidemiology · doi:10.1097/ede.0b013e31818f6651 · Cited by 113 · see citing works
Research Review: The role of diet in the treatment of attention‐deficit/hyperactivity disorder – an appraisal of the evidence on efficacy and recommendations on the design of future studies
Stevenson, J., Buitelaar, J., Cortese, S., Ferrin, M., Konofal, E., Lecendreux, M., Simonoff, E., Wong, I. C. K., & Sonuga‐Barke, E. (2014) · Journal of Child Psychology and Psychiatry · doi:10.1111/jcpp.12215 · Cited by 106 · see citing works
Antenatal interventions to reduce maternal distress: a systematic review and meta‐analysis of randomised trials
Fontein‐Kuipers, Y., Nieuwenhuijze, M., Ausems, M., Budé, L., & de Vries, R. (2014) · BJOG: An International Journal of Obstetrics & Gynaecology · doi:10.1111/1471-0528.12500 · Cited by 91 · see citing works
Development of the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial Protocol: A National Cluster-Randomized Trial of Resident Duty Hour Policies
Bilimoria, K. Y., Chung, J. W., Hedges, L. V., Dahlke, A. R., Love, R., Cohen, M. E., Tarpley, J., Mellinger, J., Mahvi, D. M., Kelz, R. R., et al. (2016) · JAMA Surgery · doi:10.1001/jamasurg.2015.4990 · Cited by 87 · see citing works
When is the Story in the Subgroups?: Strategies for Interpreting and Reporting Intervention Effects for Subgroups
Bloom, H. S., & Michalopoulos, C. (2013) · Prevention Science · doi:10.1007/s11121-010-0198-x · Cited by 83 · see citing works
Effects of enalapril in systolic heart failure patients with and without chronic kidney disease: insights from the SOLVD Treatment trial
Bowling, C. B., Sanders, P. W., Allman, R. M., Rogers, W. J., Patel, K., Aban, I. B., Rich, M. W., Pitt, B., White, M., Bakris, G. C., et al. (2013) · International Journal of Cardiology · doi:10.1016/j.ijcard.2011.12.056 · Cited by 85 · see citing works
Older adults respond better to psychological therapy than working-age adults: evidence from a large sample of mental health service attendees
Saunders, R., Buckman, J. E. J., Stott, J., Leibowitz, J., Aguirre, E., John, A., Lewis, G., Cape, J., & Pilling, S. (2021) · Journal of Affective Disorders · doi:10.1016/j.jad.2021.06.084 · Cited by 81 · see citing works
The lipid‐lowering effect of levothyroxine in patients with subclinical hypothyroidism: A systematic review and meta‐analysis of randomized controlled trials
Li, X., Wang, Y., Guan, Q., Zhao, J., & Gao, L. (2017) · Clinical Endocrinology · doi:10.1111/cen.13338 · Cited by 66 · see citing works
Digoxin discontinuation and outcomes in patients with heart failure with reduced ejection fraction
Malik, A., Masson, R., Singh, S., Wu, W.-C., Packer, M., Pitt, B., Waagstein, F., Morgan, C. J., Allman, R. M., Fonarow, G. C., et al. (2019) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2019.05.064 · Cited by 55 · see citing works
Efficacy and safety profile of SGLT2 inhibitors in the elderly: how is the benefit/risk balance?
Scheen, A. J., & Bonnet, F. (2023) · Diabetes & Metabolism · doi:10.1016/j.diabet.2023.101419 · Cited by 51 · see citing works
Outcome based subgroup analysis: a neglected concern
Hirji, K. F., & Fagerland, M. W. (2009) · Trials · doi:10.1186/1745-6215-10-33 · Cited by 41 · see citing works
Justification and reporting of subgroup analyses were lacking or inadequate in randomized controlled trials
Fan, J., Song, F., & Bachmann, M. O. (2019) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2018.12.009 · Cited by 31 · see citing works
The Effectiveness of Family‐Based Cognitive‐Behavior Grief Therapy to Prevent Complicated Grief in Relatives of Suicide Victims: The Mediating Role of Suicide Ideation
de Groot, M., Neeleman, J., van der Meer, K., & Burger, H. (2010) · Suicide and Life-Threatening Behavior · doi:10.1521/suli.2010.40.5.425 · Cited by 34 · see citing works
How often can meta-analyses of individual-level data individualize treatment? A meta-epidemiologic study
Schuit, E., Li, A. H., & Ioannidis, J. P. A. (2019) · International Journal of Epidemiology · doi:10.1093/ije/dyy239 · Cited by 27 · see citing works
Methodological quality is underrated in systematic reviews and meta-analyses in health psychology
Oliveras, I., Losilla, J.-M., & Vives, J. (2017) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.05.002 · Cited by 15 · see citing works

Valid randomization‐basedp‐values for partially post hoc subgroup analyses
Lee, J. J., & Rubin, D. B. (2015) · Statistics in Medicine · doi:10.1002/sim.6531
Out-of-hospital cardiac arrest at place of residence is associated with worse outcome – A post-hoc analysis of the TTM-trial
Andréll, C., Dankiewicz, J., & Friberg, H. (2017) · Resuscitation · doi:10.1016/j.resuscitation.2017.11.014
Anti-acid treatment in patients with IPF: interpret results from post-hoc, subgroup, and exploratory analyses with great caution
Raghu, G. (2016) · The Lancet Respiratory Medicine · doi:10.1016/s2213-2600(16)30234-x · Cited by 7 · see citing works
Subgroup analysis versus post-hoc analysis
Mullins, C. D. (2001) · Clinical Therapeutics · doi:10.1016/s0149-2918(01)80091-6 · Cited by 1 · see citing works
DOP048. Delayed response to golimumab therapy: UC patient characteristics and long-term clinical outcome—post-hoc analyses from the PURSUIT programme
(2016) · Journal of Crohn s and Colitis · doi:10.1093/ecco-jcc/jjw019.077 · Cited by 1 · see citing works

Authors: Rothwell, P. M.
Affiliations: University of Oxford (GB)
Corresponding author: Rothwell, Peter M
ORCID: Rothwell, Peter M
Venue: The Lancet
Publisher: Elsevier BV
Published: 2005-01
Volume: 365
Issue: 9454
Pages: 176-186
ISSN: 0099-5355 (ISSN-L)
0140-6736
DOI: 10.1016/s0140-6736(05)17709-5
OpenAlex: W2148173212
Cited by: 942
References: 134
Citations by year: 2026: 35 · 2025: 56 · 2024: 45 · 2023: 34 · 2022: 42 · 2021: 50 · 2020: 53 · 2019: 47 · 2018: 33 · 2017: 65 · 2016: 66 · 2015: 56 · 2014: 42 · 2013: 40 · 2012: 50
FWCI: 35.90
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: The Lancet (publishedVersion)
PubMed (publishedVersion)
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 › Advanced Causal Inference Techniques
Keywords: subgroup analysis, randomized controlled trials, treatment effect heterogeneity, pragmatic trials, trial design, post hoc analysis, treatment timing, trial power, meta-analysis
MeSH terms: Data Interpretation, Statistical, Humans, Research Design, Randomized Controlled Trials as Topic, Treatment Outcome

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review

Subgroup analysis in randomised controlled trials: importance, indications, and interpretation

Abstract

Integrity signals

Claims the paper makes

Claims other papers make about this one

Cites

Cited by

Related

Record

About these checks