Is a subgroup effect believable? Updating criteria to evaluate the credibility of subgroup analyses

How can we tell the difference between spurious and real subgroup effects? This article identifies new criteria and proposes a checklist for judging the credibility of subgroup analyses

[1]  G. Van den Berghe,et al.  Intensive insulin therapy in the medical ICU. , 2006, The New England journal of medicine.

[2]  Gordon H. Guyatt,et al.  The safety of long-acting beta-agonists among patients with asthma using inhaled corticosteroids: systematic review and metaanalysis. , 2008, American journal of respiratory and critical care medicine.

[3]  A R Feinstein,et al.  The problem of cogent subgroups: a clinicostatistical tragedy. , 1998, Journal of Clinical Epidemiology.

[4]  S. Assmann,et al.  Subgroup analysis and other (mis)uses of baseline data in clinical trials , 2000, The Lancet.

[5]  Nancy R Cook,et al.  Use of aspirin as primary prevention of cardiovascular events. , 2006, JAMA.

[6]  D. Moher,et al.  CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials , 2010, BMC medicine.

[7]  D G Altman,et al.  Within trial variation--a false trail? , 1998, Journal of clinical epidemiology.

[8]  R. McKelvie,et al.  Necessary cautions when considering digoxin in heart failure , 2007, Canadian Medical Association Journal.

[9]  M H Cullen,et al.  The benefits of chemotherapy in patient subgroups with unresectable non-small-cell lung cancer. , 2001, Annals of oncology : official journal of the European Society for Medical Oncology.

[10]  Gordon H. Guyatt,et al.  Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice; Users' Guides to the Medical Literature: Essentials of Evidence-Based Clinical Practice , 2003, BMJ : British Medical Journal.

[11]  G H Guyatt,et al.  A Consumer's Guide to Subgroup Analyses , 1992, Annals of Internal Medicine.

[12]  Nick Freemantle,et al.  Interpreting the results of secondary end points and subgroup analyses in clinical trials: should we lock the crazy aunt in the attic? , 2001, BMJ : British Medical Journal.

[13]  J. Wittes,et al.  Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. , 1991, JAMA.

[14]  Augusto Sarmiento,et al.  Randomized trial of reamed and unreamed intramedullary nailing of tibial shaft fractures. , 2008, The Journal of bone and joint surgery. American volume.

[15]  An-Wen Chan,et al.  Bias, Spin, and Misreporting: Time for Full Access to Trial Protocols and Results , 2008, PLoS medicine.

[16]  Marc F. Swiontkowski.  Randomized Trial of Reamed and Unreamed Intramedullary Nailing of Tibial Shaft Fractures , 2009 .

[17]  Gordon Guyatt,et al.  Tips for learners of evidence-based medicine: 4. Assessing heterogeneity of primary studies in systematic reviews and whether to combine their results , 2005, Canadian Medical Association Journal.

[18]  Gordon Guyatt,et al.  Meta-analyses of therapies for postmenopausal osteoporosis. IX: Summary of meta-analyses of therapies for postmenopausal osteoporosis. , 2002, Endocrine reviews.

[19]  R W Makuch,et al.  On reaching the tunnel at the end of the light. , 1997, Journal of clinical epidemiology.

[20]  R W Makuch,et al.  Clinical versus statistical considerations in the design and analysis of clinical research. , 1998, Journal of clinical epidemiology.

[21]  James E Dalen.  Use of aspirin as primary prevention of cardiovascular events. , 2006, JAMA.

[22]  Philipp Dahm,et al.  Evidence‐based urology in practice: when to believe a subgroup analysis? , 2010, BJU international.

[23]  Gordon H. Guyatt,et al.  Naturopathic Care for Chronic Low Back Pain: A Randomized Trial , 2007, PloS one.

[24]  Gianni Tognoni,et al.  Aspirin for the Primary Prevention of Cardiovascular Events in Women and Men: A Sex-Specific Meta-Analysis of Randomized Controlled Trials , 2006, JAMA.

[25]  S Senn,et al.  On wisdom after the event. , 1997, Journal of clinical epidemiology.

[26]  M Alan Brookhart,et al.  Primary prevention of cardiovascular diseases with statin therapy: a meta-analysis of randomized controlled trials. , 2006, Archives of internal medicine.

[27]  Gordon Guyatt,et al.  Meta-analyses of therapies for postmenopausal osteoporosis. I. Systematic reviews of randomized trials in osteoporosis: introduction and methodology. , 2002, Endocrine reviews.

[28]  Jan Brozek,et al.  The safety of long-acting beta-agonists among patients with asthma using inhaled corticosteroids: systematic review and metaanalysis. , 2008, American journal of respiratory and critical care medicine.

[29]  M. Egger,et al.  Incommunicable knowledge? Interpreting and applying the results of clinical trials and meta-analyses. , 1998, Journal of clinical epidemiology.

[30]  Sangeeta Mehta,et al.  Vasopressin versus norepinephrine infusion in patients with septic shock. , 2008, The New England journal of medicine.

[31]  Emil H Schemitsch,et al.  Randomized trial of reamed and unreamed intramedullary nailing of tibial shaft fractures. , 2008, The Journal of bone and joint surgery. American volume.

[32]  Marjorie S Rosenthal,et al.  Interpreting subgroup analyses: is a school-based asthma treatment program's effect modified by secondhand smoke exposure? , 2004, Archives of pediatrics & adolescent medicine.

[33]  Michael A Babyak,et al.  What You See May Not Be What You Get: A Brief, Nontechnical Introduction to Overfitting in Regression-Type Models , 2004, Psychosomatic medicine.

[34]  Elie A Akl,et al.  Low-molecular-weight heparin vs unfractionated heparin for perioperative thromboprophylaxis in patients with cancer: a systematic review and meta-analysis. , 2008, Archives of internal medicine.

[35]  Holger J Schünemann,et al.  Misuse of Baseline Comparison Tests and Subgroup Analyses in Surgical Trials , 2006, Clinical orthopaedics and related research.

[36]  Kristian Thorlund,et al.  Cooling for Neonatal Hypoxic Ischemic Encephalopathy: Do We Have the Answer? , 2007, Pediatrics.

[37]  Kevin Carroll,et al.  Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer) , 2005, The Lancet.

[38]  Stephen W Lagakos,et al.  Statistics in medicine--reporting of subgroup analyses in clinical trials. , 2007, The New England journal of medicine.

[39]  R W Makuch,et al.  Can treatment that is helpful on average be harmful to some patients? A study of the conflicting information needs of clinical inquiry and drug regulation. , 1996, Journal of clinical epidemiology.