Longford NT: Selection bias and treatment heterogeneity in clinical trials. Stat Med. 1999, 18: 1467-1474. 10.1002/(SICI)1097-0258(19990630)18:12<1467::AID-SIM149>3.0.CO;2-H.
Article
CAS
PubMed
Google Scholar
Kravitz RL, Duan N, Braslow J: Evidence-based medicine, heterogeneity of treatment effects, and the trouble with averages. Milbank Q. 2004, 82: 661-687. 10.1111/j.0887-378X.2004.00327.x.
Article
PubMed
PubMed Central
Google Scholar
Greenfield S, Kravitz R, Duan N, Kaplan SH: Heterogeneity of treatment effects: implications for guidelines, payment, and quality assessment. Am J Med. 2007, 120: S3-9. 10.1016/j.amjmed.2007.02.002.
Article
PubMed
Google Scholar
Spear BB, Heath-Chiozzi M, Huff J: Clinical application of pharmacogenetics. Trends Mol Med. 2001, 7: 201-204. 10.1016/S1471-4914(01)01986-4.
Article
CAS
PubMed
Google Scholar
Connor S: Glaxo chief: Our drugs do not work on most patients. The Independent. 2003
Google Scholar
Kent DM, Ruthazer R, Selker HP: Are some patients likely to benefit from recombinant tissue-type plasminogen activator for acute ischemic stroke even beyond 3 hours from symptom onset?. Stroke. 2003, 34: 464-467. 10.1161/01.STR.0000051506.43212.8B.
Article
CAS
PubMed
Google Scholar
Rothwell PM: Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. Lancet. 2005, 365: 176-186. 10.1016/S0140-6736(05)17709-5.
Article
PubMed
Google Scholar
Rothwell PM, Mehta Z, Howard SC, Gutnikov SA, Warlow CP: Treating individuals 3: from subgroups to individuals: general principles and the example of carotid endarterectomy. Lancet. 2005, 365: 256-265.
Article
PubMed
Google Scholar
Kent DM, Hayward RA: Limitations of applying summary results of clinical trials to individual patients: the need for risk stratification. JAMA. 2007, 298: 1209-1212. 10.1001/jama.298.10.1209.
Article
CAS
PubMed
Google Scholar
Guyatt G, Sackett D, Adachi J, Roberts R, Chong J, Rosenbloom D, Keller J: A clinician's guide for conducting randomized trials in individual patients. Cmaj. 1988, 139: 497-503.
CAS
PubMed
PubMed Central
Google Scholar
Guyatt G, Sackett D, Taylor DW, Chong J, Roberts R, Pugsley S: Determining optimal therapy – randomized trials in individual patients. N Engl J Med. 1986, 314: 889-892.
Article
CAS
PubMed
Google Scholar
Senn S: Individual response to treatment: is it a valid assumption?. BMJ. 2004, 329: 966-968. 10.1136/bmj.329.7472.966.
Article
PubMed
PubMed Central
Google Scholar
Senn S: Controversies concerning randomization and additivity in clinical trials. Stat Med. 2004, 23: 3729-3753. 10.1002/sim.2074.
Article
PubMed
Google Scholar
Hayward RA, Kent DM, Vijan S, Hofer TP: Reporting clinical trial results to inform providers, payers, and consumers. Health Aff (Millwood). 2005, 24: 1571-1581. 10.1377/hlthaff.24.6.1571.
Article
Google Scholar
Kent DM, Hayward RA, Griffith JL, Vijan S, Beshansky JR, Califf RM, Selker HP: An independently derived and validated predictive model for selecting patients with myocardial infarction who are likely to benefit from tissue plasminogen activator compared with streptokinase. Am J Med. 2002, 113: 104-111. 10.1016/S0002-9343(02)01160-9.
Article
CAS
PubMed
Google Scholar
Cook DI, Gebski VJ, Keech AC: Subgroup analysis in clinical trials. Med J Aust. 2004, 180: 289-291.
PubMed
Google Scholar
Pocock SJ, Assmann SE, Enos LE, Kasten LE: Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Stat Med. 2002, 21: 2917-2930. 10.1002/sim.1296.
Article
PubMed
Google Scholar
Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T: The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001, 134: 663-694.
Article
CAS
PubMed
Google Scholar
Stallones RA: The use and abuse of subgroup analysis in epidemiological research. Prev Med. 1987, 16: 183-194. 10.1016/0091-7435(87)90082-X.
Article
CAS
PubMed
Google Scholar
Nissen SE, Tuzcu EM, Schoenhagen P, Brown BG, Ganz P, Vogel RA, Crowe T, Howard G, Cooper CJ, Brodie B: Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary atherosclerosis: a randomized controlled trial. JAMA. 2004, 291: 1071-1080. 10.1001/jama.291.9.1071.
Article
CAS
PubMed
Google Scholar
Norman PE, Jamrozik K, Lawrence-Brown MM, Le MT, Spencer CA, Tuohy RJ, Parsons RW, Dickinson JA: Population based randomised controlled trial on impact of screening on mortality from abdominal aortic aneurysm. BMJ. 2004, 329: 1259-10.1136/bmj.38272.478438.55.
Article
PubMed
PubMed Central
Google Scholar
Ruggenenti P, Perna A, Gherardi G, Garini G, Zoccali C, Salvadori M, Scolari F, Schena FP, Remuzzi G: Renoprotective properties of ACE-inhibition in non-diabetic nephropathies with non-nephrotic proteinuria. Lancet. 1999, 354: 359-364. 10.1016/S0140-6736(98)10363-X.
Article
CAS
PubMed
Google Scholar
Torriani FJ, Rodriguez-Torres M, Rockstroh JK, Lissen E, Gonzalez-Garcia J, Lazzarin A, Carosi G, Sasadeusz J, Katlama C, Montaner J: Peginterferon Alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. N Engl J Med. 2004, 351: 438-450. 10.1056/NEJMoa040842.
Article
CAS
PubMed
Google Scholar
Matthews JN, Altman DG: Statistics notes. Interaction 2: Compare effect sizes not P values. BMJ. 1996, 313: 808-
Article
CAS
PubMed
PubMed Central
Google Scholar
Kraemer HC, Frank E, Kupfer DJ: Moderators of treatment outcomes: clinical, research, and policy importance. JAMA. 2006, 296: 1286-1289. 10.1001/jama.296.10.1286.
Article
CAS
PubMed
Google Scholar
Lu M, Lyden PD, Brott TG, Hamilton S, Broderick JP, Grotta JC: Beyond subgroup analysis: improving the clinical interpretation of treatment effects in stroke research. J Neurosci Methods. 2005, 143: 209-216. 10.1016/j.jneumeth.2004.10.002.
Article
PubMed
Google Scholar
Parker AB, Naylor CD: Subgroups, treatment effects, and baseline risks: some lessons from major cardiovascular trials. Am Heart J. 2000, 139: 952-961. 10.1067/mhj.2000.106610.
Article
CAS
PubMed
Google Scholar
Horwitz RI, Singer BH, Makuch RW, Viscoli CM: Clinical versus statistical considerations in the design and analysis of clinical research. J Clin Epidemiol. 1998, 51: 305-307. 10.1016/S0895-4356(98)00006-7.
Article
CAS
PubMed
Google Scholar
Feinstein AR: The problem of cogent subgroups: a clinicostatistical tragedy. J Clin Epidemiol. 1998, 51: 297-299. 10.1016/S0895-4356(98)00004-3.
Article
CAS
PubMed
Google Scholar
Kraemer HC, Stice E, Kazdin A, Offord D, Kupfer D: How do risk factors work together? Mediators, moderators, and independent, overlapping, and proxy risk factors. Am J Psychiatry. 2001, 158: 848-856.
Article
CAS
PubMed
Google Scholar
Kraemer HC, Wilson GT, Fairburn CG, Agras WS: Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry. 2002, 59: 877-883. 10.1001/archpsyc.59.10.877.
Article
PubMed
Google Scholar
Hernandez AV, Boersma E, Murray GD, Habbema JD, Steyerberg EW: Subgroup analyses in therapeutic cardiovascular clinical trials: are most of them misleading?. Am Heart J. 2006, 151: 257-264. 10.1016/j.ahj.2005.04.020.
Article
PubMed
Google Scholar
Assmann SF, Pocock SJ, Enos LE, Kasten LE: Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet. 2000, 355: 1064-1069. 10.1016/S0140-6736(00)02039-0.
Article
CAS
PubMed
Google Scholar
Moreira ED, 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: 1441-1446.
PubMed
Google Scholar
Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM: Statistics in medicine – reporting of subgroup analyses in clinical trials. N Engl J Med. 2007, 357: 2189-2194. 10.1056/NEJMsr077003.
Article
CAS
PubMed
Google Scholar
Chew M, Villanueva EV, Weyden Van Der MB: Life and times of the impact factor: retrospective analysis of trends for seven medical journals (1994–2005) and their Editors' views. J R Soc Med. 2007, 100: 142-150. 10.1258/jrsm.100.3.142.
Article
PubMed
PubMed Central
Google Scholar
Garfield E: Which medical journals have the greatest impact?. Ann Intern Med. 1986, 105: 313-320.
Article
CAS
PubMed
Google Scholar
Lewis S, Clarke M: Forest plots: trying to see the wood and the trees. Bmj. 2001, 322: 1479-1480. 10.1136/bmj.322.7300.1479.
Article
CAS
PubMed
PubMed Central
Google Scholar
SAS: Cary, North Carolina, USA: SAS Institute, 9
Antman EM, Cohen M, Bernink PJ, McCabe CH, Horacek T, Papuchis G, Mautner B, Corbalan R, Radley D, Braunwald E: The TIMI risk score for unstable angina/non-ST elevation MI: A method for prognostication and therapeutic decision making. Jama. 2000, 284: 835-842. 10.1001/jama.284.7.835.
Article
CAS
PubMed
Google Scholar
Ioannidis JP, Lau J: Heterogeneity of the baseline risk within patient populations of clinical trials: a proposed evaluation algorithm. Am J Epidemiol. 1998, 148: 1117-1126.
Article
CAS
PubMed
Google Scholar
Morrow DA, Antman EM, Snapinn SM, McCabe CH, Theroux P, Braunwald E: An integrated clinical approach to predicting the benefit of tirofiban in non-ST elevation acute coronary syndromes. Application of the TIMI Risk Score for UA/NSTEMI in PRISM-PLUS. Eur Heart J. 2002, 23: 223-229. 10.1053/euhj.2001.2738.
Article
CAS
PubMed
Google Scholar
Rothwell PM, Warlow CP: Prediction of benefit from carotid endarterectomy in individual patients: a risk-modelling study. European Carotid Surgery Trialists' Collaborative Group. Lancet. 1999, 353: 2105-2110. 10.1016/S0140-6736(98)11415-0.
Article
CAS
PubMed
Google Scholar
The ESPRIM trial: short-term treatment of acute myocardial infarction with molsidomine. European Study of Prevention of Infarct with Molsidomine (ESPRIM) Group. Lancet. 1994, 344: 91-97.
Google Scholar
Bjornson CL, Klassen TP, Williamson J, Brant R, Mitton C, Plint A, Bulloch B, Evered L, Johnson DW: A randomized trial of a single dose of oral dexamethasone for mild croup. N Engl J Med. 2004, 351: 1306-1313. 10.1056/NEJMoa033534.
Article
CAS
PubMed
Google Scholar
Milpied N, Deconinck E, Gaillard F, Delwail V, Foussard C, Berthou C, Gressin R, Lucas V, Colombat P, Harousseau JL: Initial treatment of aggressive lymphoma with high-dose chemotherapy and autologous stem-cell support. N Engl J Med. 2004, 350: 1287-1295. 10.1056/NEJMoa031770.
Article
CAS
PubMed
Google Scholar
Cui L, Hung HM, Wang SJ, Tsong Y: Issues related to subgroup analysis in clinical trials. J Biopharm Stat. 2002, 12: 347-358. 10.1081/BIP-120014565.
Article
PubMed
Google Scholar
Hayward RA, Kent DM, Vijan S, Hofer TP: Multivariable risk prediction can greatly enhance the statistical power of clinical trial subgroup analysis. BMC Med Res Methodol. 2006, 6: 18-10.1186/1471-2288-6-18.
Article
PubMed
PubMed Central
Google Scholar
Haiman CA, Stram DO, Wilkens LR, Pike MC, Kolonel LN, Henderson BE, Le Marchand L: Ethnic and racial differences in the smoking-related risk of lung cancer. N Engl J Med. 2006, 354: 333-342. 10.1056/NEJMoa033250.
Article
CAS
PubMed
Google Scholar
Conjeevaram HS, Fried MW, Jeffers LJ, Terrault NA, Wiley-Lucas TE, Afdhal N, Brown RS, Belle SH, Hoofnagle JH, Kleiner DE, Howell CD: Peginterferon and ribavirin treatment in African American and Caucasian American patients with hepatitis C genotype 1. Gastroenterology. 2006, 131: 470-477. 10.1053/j.gastro.2006.06.008.
Article
CAS
PubMed
Google Scholar
McDowell SE, Coleman JJ, Ferner RE: Systematic review and meta-analysis of ethnic differences in risks of adverse reactions to drugs used in cardiovascular medicine. BMJ. 2006, 332: 1177-1181. 10.1136/bmj.38803.528113.55.
Article
CAS
PubMed
PubMed Central
Google Scholar
Department of Health: A first class service: quality in the new NHS. 1998, London: Department of Health
Google Scholar
Department of Health: "Faster Access to Modern Treatment": how NICE appraisal will work. 1999, Leeds: NHS Executive
Google Scholar
Rawlins M: In pursuit of quality: the National Institute for Clinical Excellence. Lancet. 1999, 353: 1079-1082. 10.1016/S0140-6736(99)02381-8.
Article
CAS
PubMed
Google Scholar
NIH guidelines on the inclusion of women and minorities as subjects in clinical research. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html
Trusheim MR, Berndt ER, Douglas FL: Stratified medicine: strategic and economic implications of combining drugs and clinical biomarkers. Nat Rev Drug Discov. 2007, 6: 287-293. 10.1038/nrd2251.
Article
CAS
PubMed
Google Scholar
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