CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials
Tài liệu tham khảo
Rennie, 2001, CONSORT revised—improving the reporting of randomized trials, J Am Med Assoc, 285, 2006, 10.1001/jama.285.15.2006
Schulz, 1995, Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials, J Am Med Assoc, 273, 408, 10.1001/jama.1995.03520290060030
Moher, 1998, CONSORT: an evolving tool to help improve the quality of reports of randomized controlled trials. Consolidated Standards of Reporting Trials, J Am Med Assoc, 279, 1489, 10.1001/jama.279.18.1489
Kjaergard, 1999
Jüni, 2001, Systematic reviews in health care: assessing the quality of controlled clinical trials, Br Med J, 323, 42, 10.1136/bmj.323.7303.42
Veldhuyzen van Zanten, 1996, Drug treatment of functional dyspepsia: a systematic analysis of trial methodology with recommendations for design of future trials, Am J Gastroenterol, 91, 660
Talley, 1996, Psychological treatments for irritable bowel syndrome: a critique of controlled treatment trials, Am J Gastroenterol, 91, 277
Adetugbo, 2000, How well are randomized controlled trials reported in the dermatology literature?, Arch Dermatol, 136, 381, 10.1001/archderm.136.3.381
Kjaergard, 1999, Randomized clinical trials in HEPATOLOGY: predictors of quality, Hepatology, 30, 1134, 10.1002/hep.510300510
Schor, 1966, Statistical evaluation of medical journal manuscripts, J Am Med Assoc, 195, 1123, 10.1001/jama.1966.03100130097026
Gore, 1977, Misuse of statistical methods: critical assessment of articles in BMJ from January to March 1976, Br Med J, 1, 85, 10.1136/bmj.1.6053.85
Hall, 1982, Misuse of statistical methods in the Australasian surgical literature, Aust N Z J Surg, 52, 541, 10.1111/j.1445-2197.1982.tb06050.x
Altman, 1982, Statistics in medical journals, Stat Med, 1, 59, 10.1002/sim.4780010109
Pocock, 1987, Statistical problems in the reporting of clinical trials. A survey of three medical journals, N Engl J Med, 317, 426, 10.1056/NEJM198708133170706
Altman, 1994, The scandal of poor medical research, Br Med J, 308, 283, 10.1136/bmj.308.6924.283
Chan, 2005, Epidemiology and reporting of randomised trials published in PubMed journals, Lancet, 365, 1159, 10.1016/S0140-6736(05)71879-1
Hopewell, 2010, The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed, Br Med J, 340, c723, 10.1136/bmj.c723
Hollis, 1999, What is meant by intention to treat analysis? Survey of published randomised controlled trials, Br Med J, 319, 670, 10.1136/bmj.319.7211.670
Lai, 2007, Quality of reporting of key methodological items of randomized controlled trials in clinical ophthalmic journals, Ophthalmic Epidemiol, 14, 390, 10.1080/09286580701344399
Moher, 1996, Completeness of reporting of trials published in languages other than English: implications for conduct and reporting of systematic reviews, Lancet, 347, 363, 10.1016/S0140-6736(96)90538-3
Junker, 1998, Adherence to published standards of reporting: a comparison of placebo-controlled trials published in English or German, J Am Med Assoc, 280, 247, 10.1001/jama.280.3.247
Altman, 1991, Randomisation, Br Med J, 302, 1481, 10.1136/bmj.302.6791.1481
Schulz, 1994, Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals, J Am Med Assoc, 272, 125, 10.1001/jama.1994.03520020051014
1948, Streptomycin treatment of pulmonary tuberculosis: a Medical Research Council investigation, Br Med J, 2, 769, 10.1136/bmj.2.4582.769
Schulz, 1998, Randomized controlled trials, Clin Obstet Gynecol, 41, 245, 10.1097/00003081-199806000-00005
Greenland, 1990, Randomization, statistics, and causal inference, Epidemiology, 1, 421, 10.1097/00001648-199011000-00003
Armitage, 1982, The role of randomization in clinical trials, Stat Med, 1, 345, 10.1002/sim.4780010412
Kleijnen, 1997, So what’s so special about randomisation, 93
Chalmers, 1997, Assembling comparison groups to assess the effects of health care, J R Soc Med, 90, 379, 10.1177/014107689709000706
Nicolucci, 1989, Quality, evolution, and clinical implications of randomized, controlled trials on the treatment of lung cancer. A lost opportunity for meta-analysis, J Am Med Assoc, 262, 2101, 10.1001/jama.1989.03430150069028
Ah-See, 1998, A qualitative assessment of randomized controlled trials in otolaryngology, J Laryngol Otol, 112, 460, 10.1017/S0022215100140770
Altman, 1990, Randomisation and baseline comparisons in clinical trials, Lancet, 335, 149, 10.1016/0140-6736(90)90014-V
Thornley, 1998, Content and quality of 2000 controlled trials in schizophrenia over 50 years, Br Med J, 317, 1181, 10.1136/bmj.317.7167.1181
DerSimonian, 1982, Reporting on methods in clinical trials, N Engl J Med, 306, 1332, 10.1056/NEJM198206033062204
1994, A proposal for structured reporting of randomized controlled trials. The Standards of Reporting Trials Group, J Am Med Assoc, 272, 1926, 10.1001/jama.1994.03520240054041
1994, Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature, Ann Intern Med, 121, 894, 10.7326/0003-4819-121-11-199412010-00015
Rennie, 1995, Reporting randomized controlled trials. An experiment and a call for responses from readers, J Am Med Assoc, 273, 1054, 10.1001/jama.1995.03520370096044
Begg, 1996, Improving the quality of reporting of randomized controlled trials: the CONSORT statement, J Am Med Assoc, 276, 637, 10.1001/jama.1996.03540080059030
Piaggio, 2006, Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement, J Am Med Assoc, 295, 1152, 10.1001/jama.295.10.1152
Campbell, 2004, CONSORT statement: extension to cluster randomised trials, Br Med J, 328, 702, 10.1136/bmj.328.7441.702
Zwarenstein, 2008, Improving the reporting of pragmatic trials: an extension of the CONSORT statement, Br Med J, 337, a2390, 10.1136/bmj.a2390
Ioannidis, 2004, Better reporting of harms in randomized trials: an extension of the CONSORT statement, Ann Intern Med, 141, 781, 10.7326/0003-4819-141-10-200411160-00009
Boutron, 2008, Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration, Ann Intern Med, 148, 295, 10.7326/0003-4819-148-4-200802190-00008
Gagnier, 2006, Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement, Ann Intern Med, 144, 364, 10.7326/0003-4819-144-5-200603070-00013
Hopewell, 2008, CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration, PLoS Med, 5, e20, 10.1371/journal.pmed.0050020
Siegel, 1996, Recommendations for reporting cost-effectiveness analyses. Panel on cost-effectiveness in health and medicine, J Am Med Assoc, 276, 1339, 10.1001/jama.1996.03540160061034
Drummond, 1996, Guidelines for authors and peer reviewers of economic submissions to the BMJ. The BMJ Economic Evaluation Working Party, Br Med J, 313, 275, 10.1136/bmj.313.7052.275
Lang, 1997
Davidoff, 2000, News from the International Committee of Medical Journal Editors, Ann Intern Med, 133, 229, 10.7326/0003-4819-133-3-200008010-00017
Plint, 2006, Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review, Med J Aust, 185, 263, 10.5694/j.1326-5377.2006.tb00557.x
Egger, 2001, Value of flow diagrams in reports of randomized controlled trials, J Am Med Assoc, 285, 1996, 10.1001/jama.285.15.1996
Moher, 2001, The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials, Ann Intern Med, 134, 657, 10.7326/0003-4819-134-8-200104170-00011
Moher, 2001, The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials, J Am Med Assoc, 285, 1987, 10.1001/jama.285.15.1987
Moher, 2001, The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials, Lancet, 357, 1191, 10.1016/S0140-6736(00)04337-3
Chan, 2004, Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles, J Am Med Assoc, 291, 2457, 10.1001/jama.291.20.2457
Al-Marzouki, 2008, Selective reporting in clinical trials: analysis of trial protocols accepted by the Lancet, Lancet, 372, 201, 10.1016/S0140-6736(08)61060-0
Dwan, 2008, Systematic review of the empirical evidence of study publication bias and outcome reporting bias, PLoS ONE, 3, e3081, 10.1371/journal.pone.0003081
Altman, 2001, The revised CONSORT statement for reporting randomized trials: explanation and elaboration, Ann Intern Med, 134, 663, 10.7326/0003-4819-134-8-200104170-00012
Schulz, 2010, CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials, Br Med J, 340, c332, 10.1136/bmj.c332
Pocock, 1983
Meinert, 1986
Friedman, 1998
Bolliger, 2000, Smoking reduction with oral nicotine inhalers: double blind, randomised clinical trial of efficacy and safety, Br Med J, 321, 329, 10.1136/bmj.321.7257.329
Dickersin, 2002, Development of the Cochrane Collaboration’s CENTRAL Register of controlled clinical trials, Eval Health Prof, 25, 38, 10.1177/0163278702025001004
Hopewell, 2008, CONSORT for reporting randomised trials in journal and conference abstracts, Lancet, 371, 281, 10.1016/S0140-6736(07)61835-2
2006, The impact of open access upon public health, PLoS Med, 3, e252, 10.1371/journal.pmed.0030252
Harbourt, 1995, Structured abstracts in MEDLINE, 1989–1991, Bull Med Libr Assoc, 83, 190
Harris, 2002, The accuracy of abstracts in psychology journals, J Psychol, 136, 141
Pitkin, 1999, Accuracy of data in abstracts of published research articles, J Am Med Assoc, 281, 1110, 10.1001/jama.281.12.1110
Ward, 2004, Accuracy of abstracts for original research articles in pharmacy journals, Ann Pharmacother, 38, 1173, 10.1345/aph.1D416
Gøtzsche, 2006, Believability of relative risks and odds ratios in abstracts: cross sectional study, Br Med J, 333, 231, 10.1136/bmj.38895.410451.79
Ioannidis, 2001, Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas, J Am Med Assoc, 285, 437, 10.1001/jama.285.4.437
Haynes, 1990, More informative abstracts revisited, Ann Intern Med, 113, 69, 10.7326/0003-4819-113-1-69
Taddio, 1994, Quality of nonstructured and structured abstracts of original research articles in the British Medical Journal, the Canadian Medical Association Journal and the Journal of the American Medical Association, CMAJ, 150, 1611
Wager, 2008, Technical editing of research reports in biomedical journals, Cochrane Database Syst Rev, 10.1002/14651858.MR000002.pub3
Hartley, 1996, Obtaining information accurately and quickly: are structured abstracts more efficient?, J Inform Sci, 22, 349, 10.1177/016555159602200503
Gilligan, 2007, Preoperative chemotherapy in patients with resectable non-small cell lung cancer: results of the MRC LU22/NVALT 2/EORTC 08012 multicentre randomised trial and update of systematic review, Lancet, 369, 1929, 10.1016/S0140-6736(07)60714-4
Sandler, 1999, Lack of benefit of a single dose of synthetic human secretin in the treatment of autism and pervasive developmental disorder, N Engl J Med, 341, 1801, 10.1056/NEJM199912093412404
World Medical Association, 2008
Lau, 1992, Cumulative meta-analysis of therapeutic trials for myocardial infarction, N Engl J Med, 327, 248, 10.1056/NEJM199207233270406
Fergusson, 2005, Randomized controlled trials of aprotinin in cardiac surgery: could clinical equipoise have stopped the bleeding?, Clin Trials, 2, 218, 10.1191/1740774505cn085oa
Savulescu, 1996, Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability, Br Med J, 313, 1390, 10.1136/bmj.313.7069.1390
Sadler, 2000, A randomised controlled trial and meta-analysis of active management of labour, BJOG, 107, 909, 10.1111/j.1471-0528.2000.tb11091.x
Bath, 1998, Quality of full and final publications reporting acute stroke trials: a systematic review, Stroke, 29, 2203, 10.1161/01.STR.29.10.2203
Blumer, 2009, Controlled clinical trial of zolpidem for the treatment of insomnia associated with attention-deficit/hyperactivity disorder in children 6 to 17 years of age, Pediatrics, 123, e770, 10.1542/peds.2008-2945
Sabatine, 2009, Otamixaban for the treatment of patients with non-ST-elevation acute coronary syndromes (SEPIA-ACS1 TIMI 42): a randomised, double-blind, active-controlled, phase 2 trial, Lancet, 374, 787, 10.1016/S0140-6736(09)61454-9
Grant, 2005, Issues in data monitoring and interim analysis of trials, Health Technol Assess, 9, 1, 10.3310/hta9070
Gallo, 2006, PhRMA Working Group on adaptive designs, “White Paper”, Drug Inf J, 40, 421, 10.1177/216847900604000407
Brown, 2009, Adaptive designs for randomized trials in public health, Annu Rev Public Health, 30, 1, 10.1146/annurev.publhealth.031308.100223
Kelly, 2005, A practical comparison of group-sequential and adaptive designs, J Biopharm Stat, 15, 719, 10.1081/BIP-200062859
Pildal, 2005, Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study, Br Med J, 330, 1049, 10.1136/bmj.38414.422650.8F
Chan, 2008, Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols, Br Med J, 337, a2299, 10.1136/bmj.a2299
Ndekha, 2009, Supplementary feeding with either ready-to-use fortified spread or corn-soy blend in wasted adults starting antiretroviral therapy in Malawi: randomised, investigator blinded, controlled trial, Br Med J, 338, 1867, 10.1136/bmj.b1867
Rothwell, 2005, External validity of randomised controlled trials: "to whom do the results of this trial apply?", Lancet, 365, 82, 10.1016/S0140-6736(04)17670-8
Fuks, 1998, A study in contrasts: eligibility criteria in a twenty-year sample of NSABP and POG clinical trials. National Surgical Adjuvant Breast and Bowel Program. Pediatric Oncology Group, J Clin Epidemiol, 51, 69, 10.1016/S0895-4356(97)00240-0
Shapiro, 2000, Reporting the study populations of clinical trials. Clear transmission or static on the line?, J Clin Epidemiol, 53, 973, 10.1016/S0895-4356(00)00227-4
Gandhi, 2005, Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols, AIDS, 19, 1885, 10.1097/01.aids.0000189866.67182.f7
Hall, 1996, Methodologic standards in surgical trials, Surgery, 119, 466, 10.1016/S0039-6060(96)80149-8
Weiss, 2008, Generalizability of the results of randomized trials, Arch Intern Med, 168, 133, 10.1001/archinternmed.2007.30
Devereaux, 2008, Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial, Lancet, 371, 1839, 10.1016/S0140-6736(08)60601-7
Rannou, 2009, Splint for base-of-thumb osteoarthritis: a randomized trial, Ann Intern Med, 150, 661, 10.7326/0003-4819-150-10-200905190-00003
Glasziou, 2008, What is missing from descriptions of treatment in trials and reviews?, Br Med J, 336, 1472, 10.1136/bmj.39590.732037.47
Mease, 2000, Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial, Lancet, 356, 385, 10.1016/S0140-6736(00)02530-7
McDowell, 2006
Streiner, 2003
Clarke, 2007, Standardising outcomes for clinical trials and systematic reviews, Trials, 8, 39, 10.1186/1745-6215-8-39
Sanders, 1998, Reporting on quality of life in randomised controlled trials: bibliographic study, Br Med J, 317, 1191, 10.1136/bmj.317.7167.1191
Gøtzsche, 1989, Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis, Control Clin Trials, 10, 31, 10.1016/0197-2456(89)90017-2
Marshall, 2000, Unpublished rating scales: a major source of bias in randomised controlled trials of treatments for schizophrenia, Br J Psychiatry, 176, 249, 10.1192/bjp.176.3.249
Jadad, 1999
Schachter, 2000
Dargie, 2001, Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial, Lancet, 357, 1385, 10.1016/S0140-6736(00)04560-8
Chan, 2004, Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research, CMAJ, 171, 735, 10.1503/cmaj.1041086
Vermeulen, 2009, Intravenous fluid restriction after major abdominal surgery: a randomized blinded clinical trial, Trials, 10, 50, 10.1186/1745-6215-10-50
Fox, 2008, Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial, Lancet, 372, 807, 10.1016/S0140-6736(08)61170-8
Campbell, 1995, Estimating sample sizes for binary, ordered categorical, and continuous outcomes in two group comparisons, Br Med J, 311, 1145, 10.1136/bmj.311.7013.1145
Guyatt, 2008, In the era of systematic reviews, does the size of an individual trial still matter, PLoS Med, 5, e4, 10.1371/journal.pmed.0050004
Schulz, 2005, Sample size calculations in randomised trials: mandatory and mystical, Lancet, 365, 1348, 10.1016/S0140-6736(05)61034-3
Halpern, 2002, The continuing unethical conduct of underpowered clinical trials, J Am Med Assoc, 288, 358, 10.1001/jama.288.3.358
Altman, 1995, Absence of evidence is not evidence of absence, Br Med J, 311, 485, 10.1136/bmj.311.7003.485
Moher, 1994, Statistical power, sample size, and their reporting in randomized controlled trials, J Am Med Assoc, 272, 122, 10.1001/jama.1994.03520020048013
Freiman, 1978, The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 "negative" trials, N Engl J Med, 299, 690, 10.1056/NEJM197809282991304
Charles, 2009, Reporting of sample size calculation in randomised controlled trials: review, Br Med J, 338, b1732, 10.1136/bmj.b1732
Yusuf, 1984, Why do we need some large, simple randomized trials?, Stat Med, 3, 409, 10.1002/sim.4780030421
Goodman, 1994, The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results, Ann Intern Med, 121, 200, 10.7326/0003-4819-121-3-199408010-00008
Galgiani, 2000, Comparison of oral fluconazole and itraconazole for progressive, nonmeningeal coccidioidomycosis. A randomized, double-blind trial. Mycoses Study Group, Ann Intern Med, 133, 676, 10.7326/0003-4819-133-9-200011070-00009
Connolly, 2009, Effect of clopidogrel added to aspirin in patients with atrial fibrillation, N Engl J Med, 360, 2066, 10.1056/NEJMoa0901301
Geller, 1987, Interim analyses in randomized clinical trials: ramifications and guidelines for practitioners, Biometrics, 43, 213, 10.2307/2531962
Berry, 1985, Interim analyses in clinical trials: classical vs. Bayesian approaches, Stat Med, 4, 521, 10.1002/sim.4780040412
Pocock, 1992, When to stop a clinical trial, Br Med J, 305, 235, 10.1136/bmj.305.6847.235
DeMets, 1999, The agonising negative trend in monitoring of clinical trials, Lancet, 354, 1983, 10.1016/S0140-6736(99)03464-9
Buyse, 1993, Interim analyses, stopping rules and data monitoring in clinical trials in Europe, Stat Med, 12, 509, 10.1002/sim.4780120517
Sydes, 2004, Reported use of data monitoring committees in the main published reports of randomized controlled trials: a cross-sectional study, Clin Trials, 1, 48, 10.1191/1740774504cn003oa
Montori, 2005, Randomized trials stopped early for benefit: a systematic review, J Am Med Assoc, 294, 2203, 10.1001/jama.294.17.2203
Coutinho, 2008, Uterine exteriorization compared with in situ repair at cesarean delivery: a randomized controlled trial, Obstet Gynecol, 111, 639, 10.1097/AOG.0b013e31816521e2
Jüni, 2001, Assessing the quality of controlled clinical trials
Creinin, 2008, Multicenter comparison of the contraceptive ring and patch: a randomized controlled trial, Obstet Gynecol, 111, 267, 10.1097/01.AOG.0000298338.58511.d1
Tate, 2003, Effects of internet behavioral counseling on weight loss in adults at risk for type 2 diabetes: a randomized trial, J Am Med Assoc, 289, 1833, 10.1001/jama.289.14.1833
Lachin, 1988, Properties of simple randomization in clinical trials, Control Clin Trials, 9, 312, 10.1016/0197-2456(88)90046-3
Peto, 1976, Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design, Br J Cancer, 34, 585, 10.1038/bjc.1976.220
Schulz, 2006
Altman, 1999, How to randomise, Br Med J, 319, 703, 10.1136/bmj.319.7211.703
Schulz, 1995, Subverting randomization in controlled trials, J Am Med Assoc, 274, 1456, 10.1001/jama.1995.03530180050029
Enas, 1990, Baseline comparability in clinical trials: prevention of poststudy anxiety, Drug Inf J, 24, 541, 10.1177/009286159002400312
Treasure, 1998, Minimisation: the platinum standard for trials? Randomisation doesn’t guarantee similarity of groups; minimisation does, Br Med J, 317, 362, 10.1136/bmj.317.7155.362
Sinei, 1990, Preventing IUCD-related pelvic infection: the efficacy of prophylactic doxycycline at insertion, Br J Obstet Gynaecol, 97, 412, 10.1111/j.1471-0528.1990.tb01828.x
Radford, 2006, Effectiveness of low-Dye taping for the short-term treatment of plantar heel pain: a randomised trial, BMC Musculoskelet Disord, 7, 64, 10.1186/1471-2474-7-64
Chalmers, 1987, Meta-analysis of clinical trials as a scientific discipline. I: control of bias and comparison with large co-operative trials, Stat Med, 6, 315, 10.1002/sim.4780060320
Pocock, 1982, Statistical aspects of clinical trial design, Statistician, 31, 1, 10.2307/2988097
Haag, 1998, Technologies for automating randomized treatment assignment in clinical trials, Drug Inf J, 32, 11, 10.1177/009286159803200102
Piaggio, 2003, The reporting of methods for reducing and detecting bias: an example from the WHO Misoprostol Third Stage of Labour equivalence randomised controlled trial, BMC Med Res Methodol, 3, 19, 10.1186/1471-2288-3-19
Pildal, 2007, Impact of allocation concealment on conclusions drawn from meta-analyses of randomized trials, Int J Epidemiol, 36, 847, 10.1093/ije/dym087
Wood, 2008, Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study, Br Med J, 336, 601, 10.1136/bmj.39465.451748.AD
McCandlish, 1998, A randomised controlled trial of care of the perineum during second stage of normal labour, Br J Obstet Gynaecol, 105, 1262, 10.1111/j.1471-0528.1998.tb10004.x
Webster, 2008, Routine care of peripheral intravenous catheters versus clinically indicated replacement: randomised controlled trial, Br Med J, 337, a339, 10.1136/bmj.a339
Smith, 2008, Chronic care model and shared care in diabetes: randomized trial of an electronic decision support system, Mayo Clin Proc, 83, 747, 10.4065/83.7.747
Sacks, 2009, Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates, N Engl J Med, 360, 859, 10.1056/NEJMoa0804748
Kaptchuk, 1998, Intentional ignorance: a history of blind assessment and placebo controls in medicine, Bull Hist Med, 72, 389, 10.1353/bhm.1998.0159
Guyatt, 1984, Effect of encouragement on walking test performance, Thorax, 39, 818, 10.1136/thx.39.11.818
Gøtzsche, 1996, Blinding during data analysis and writing of manuscripts, Control Clin Trials, 17, 285, 10.1016/0197-2456(95)00263-4
Karlowski, 1975, Ascorbic acid for the common cold. A prophylactic and therapeutic trial, J Am Med Assoc, 231, 1038, 10.1001/jama.1975.03240220018013
Noseworthy, 1994, The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial, Neurology, 44, 16, 10.1212/WNL.44.1.16
Carley, 2000, An open prospective randomised trial to reduce the pain of blood glucose testing: ear versus thumb, Br Med J, 321, 20, 10.1136/bmj.321.7252.20
Schulz, 2002, The landscape and lexicon of blinding in randomized trials, Ann Intern Med, 136, 254, 10.7326/0003-4819-136-3-200202050-00022
Day, 2000, Statistics notes: blinding in clinical trials and other studies, Br Med J, 321, 504, 10.1136/bmj.321.7259.504
Montori, 2002, In the dark: the reporting of blinding status in randomized controlled trials, J Clin Epidemiol, 55, 787, 10.1016/S0895-4356(02)00446-8
Cheng, 2000, Randomized controlled trials in cystic fibrosis (1966–1997) categorized by time, design, and intervention, Pediatr Pulmonol, 29, 1, 10.1002/(SICI)1099-0496(200001)29:1<1::AID-PPUL1>3.0.CO;2-1
Lang, 2000, Masking or blinding? An unscientific survey of mostly medical journal editors on the great debate, Med Gen Med, 2, E25
Devereaux, 2001, Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials, J Am Med Assoc, 285, 2000, 10.1001/jama.285.15.2000
Haahr, 2006, Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors, Clin Trials, 3, 360, 10.1177/1740774506069153
Meinert, 1998, Masked monitoring in clinical trials—blind stupidity?, N Engl J Med, 338, 1381, 10.1056/NEJM199805073381911
Mills, 2003, The safety of over-the-counter niacin. A randomized placebo-controlled trial [ISRCTN18054903], BMC Clin Pharmacol, 3, 4, 10.1186/1472-6904-3-4
Schulz, 1996, Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology, Br Med J, 312, 742, 10.1136/bmj.312.7033.742
Fergusson, 2004, Turning a blind eye: the success of blinding reported in a random sample of randomised, placebo controlled trials, Br Med J, 328, 432, 10.1136/bmj.37952.631667.EE
Sackett, 2004, Turning a blind eye: why we don’t test for blindness at the end of our trials, Br Med J, 328, 1136, 10.1136/bmj.328.7448.1136-a
Astrup, 2009, Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study, Lancet, 374, 1606, 10.1016/S0140-6736(09)61375-1
Altman, 2000, Statistical guidelines for contributors to medical journals, 171
Altman, 1997, Statistics notes. Units of analysis, Br Med J, 314, 1874, 10.1136/bmj.314.7098.1874
Bolton, 1998, Independence and statistical inference in clinical trial designs: a tutorial review, J Clin Pharmacol, 38, 408, 10.1002/j.1552-4604.1998.tb04444.x
Greenland, 2000, Principles of multilevel modelling, Int J Epidemiol, 29, 158, 10.1093/ije/29.1.158
Albert, 2008, Effect of folic acid and B vitamins on risk of cardiovascular events and total mortality among women at high risk for cardiovascular disease: a randomized trial, J Am Med Assoc, 299, 2027, 10.1001/jama.299.17.2027
Matthews, 1996, Interaction 3: how to examine heterogeneity, Br Med J, 313, 862, 10.1136/bmj.313.7061.862
Assmann, 2000, Subgroup analysis and other (mis)uses of baseline data in clinical trials, Lancet, 355, 1064, 10.1016/S0140-6736(00)02039-0
Matthews, 1996, Statistics notes. Interaction 2: compare effect sizes not P values, Br Med J, 313, 808, 10.1136/bmj.313.7060.808
Oxman, 1992, A consumer’s guide to subgroup analyses, Ann Intern Med, 116, 78, 10.7326/0003-4819-116-1-78
Steyerberg, 2000, Clinical trials in acute myocardial infarction: should we adjust for baseline characteristics?, Am Heart J, 139, 745, 10.1016/S0002-8703(00)90001-2
Altman, 1998, Adjustment for covariate imbalance, 1000
Mullner, 2002, Reporting on statistical methods to adjust for confounding: a cross-sectional survey, Ann Intern Med, 136, 122, 10.7326/0003-4819-136-2-200201150-00009
Concato, 1993, The risk of determining risk with multivariable models, Ann Intern Med, 118, 201, 10.7326/0003-4819-118-3-199302010-00009
Bender, 1996, Logistic regression models used in medical research are poorly presented, Br Med J, 313, 628, 10.1136/bmj.313.7057.628
Khan, 1999, Logistic regression models in obstetrics and gynecology literature, Obstet Gynecol, 93, 1014
Sackett, 1979, Controversy in counting and attributing events in clinical trials, N Engl J Med, 301, 1410, 10.1056/NEJM197912273012602
May, 1981, The randomized clinical trial: bias in analysis, Circulation, 64, 669, 10.1161/01.CIR.64.4.669
Altman, 1994, More on zidovudine in asymptomatic HIV infection, N Engl J Med, 330, 1758, 10.1056/NEJM199406163302415
Meinert, 1998, Beyond CONSORT: need for improved reporting standards for clinical trials. Consolidated Standards of Reporting Trials, J Am Med Assoc, 279, 1487, 10.1001/jama.279.18.1487
Grant, 2008, Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease: UK collaborative randomised trial, Br Med J, 337, a2664, 10.1136/bmj.a2664
van Loon, 1997, Randomised controlled trial of magnetic-resonance pelvimetry in breech presentation at term, Lancet, 350, 1799, 10.1016/S0140-6736(97)05431-7
Brown, 2000, Morbidity and mortality in patients randomised to double-blind treatment with a long-acting calcium-channel blocker or diuretic in the International Nifedipine GITS study: Intervention as a Goal in Hypertension Treatment (INSIGHT), Lancet, 356, 366, 10.1016/S0140-6736(00)02527-7
LaCroix, 2000, Low-dose hydrochlorothiazide and preservation of bone mineral density in older adults. A randomized, double-blind, placebo-controlled trial, Ann Intern Med, 133, 516, 10.7326/0003-4819-133-7-200010030-00010
Shuster, 1991, Median follow-up in clinical trials, J Clin Oncol, 9, 191, 10.1200/JCO.1991.9.1.191
Altman, 1995, Review of survival analyses published in cancer journals, Br J Cancer, 72, 511, 10.1038/bjc.1995.364
Auvert, 2005, Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265, Trial PLoS Med, 2, e298, 10.1371/journal.pmed.0020298
Diggle, 2000, Effect of needle length on incidence of local reactions to routine immunisation in infants aged 4 months: randomised controlled trial, Br Med J, 321, 931, 10.1136/bmj.321.7266.931
Pocock, 1999, Trials stopped early: too good to be true?, Lancet, 353, 943, 10.1016/S0140-6736(98)00379-1
Hughes, 1988, Stopping rules and estimation problems in clinical trials, Stat Med, 7, 1231, 10.1002/sim.4780071204
Kiri, 2004, Treatment effects monitoring committees and early stopping in large clinical trials, Clin Trials, 1, 40, 10.1191/1740774504cn014oa
Psaty, 2003, Stopping medical research to save money: a broken pact with researchers and patients, J Am Med Assoc, 289, 2128, 10.1001/jama.289.16.2128
Temple, 2006, FDA perspective on trials with interim efficacy evaluations, Stat Med, 25, 3245, 10.1002/sim.2631
Yusuf, 2008, Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial, Lancet, 372, 1174, 10.1016/S0140-6736(08)61242-8
Senn, 1995, Base logic: tests of baseline balance in randomized clinical trials, Clin Res Regul Aff, 12, 171, 10.3109/10601339509019426
Altman, 1985, Comparability of randomised groups, Statistician, 34, 125, 10.2307/2987510
Heit, 2000, Ardeparin sodium for extended out-of-hospital prophylaxis against venous thromboembolism after total hip or knee replacement. A randomized, double-blind, placebo-controlled trial, Ann Intern Med, 132, 853, 10.7326/0003-4819-132-11-200006060-00002
Haderslev, 2000, Alendronate increases lumbar spine bone mineral density in patients with Crohn’s disease, Gastroenterology, 119, 639, 10.1053/gast.2000.16518
Fields, 1970, Joint study of extracranial arterial occlusion. V. Progress report of prognosis following surgery or nonsurgical treatment for transient cerebral ischemic attacks and cervical carotid artery lesions, J Am Med Assoc, 211, 1993, 10.1001/jama.1970.03170120039008
Lee, 1991, Analysis of clinical trials by treatment actually received: is it really an option?, Stat Med, 10, 1595, 10.1002/sim.4780101011
Lewis, 1993, Intention to treat—who should use ITT?, Br J Cancer, 68, 647, 10.1038/bjc.1993.402
Lachin, 2000, Statistical considerations in the intent-to-treat principle, Control Clin Trials, 21, 526, 10.1016/S0197-2456(00)00092-1
Sheiner, 1995, Intention-to-treat analysis and the goals of clinical trials, Clin Pharmacol Ther, 57, 6, 10.1016/0009-9236(95)90260-0
Nagelkerke, 2000, Estimating treatment effects in randomized clinical trials in the presence of non-compliance, Stat Med, 19, 1849, 10.1002/1097-0258(20000730)19:14<1849::AID-SIM506>3.0.CO;2-1
Melander, 2003, Evidence b(i)ased medicine–selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications, Br Med J, 326, 1171, 10.1136/bmj.326.7400.1171
Gravel, 2007, The intention-to-treat approach in randomized controlled trials: are authors saying what they do and doing what they say?, Clin Trials, 4, 350, 10.1177/1740774507081223
Kruse, 2002, Intention-to-treat analysis: who is in? Who is out?, J Fam Pract, 51, 969
Herman, 2009, Intention-to-treat analysis and accounting for missing data in orthopaedic randomized clinical trials, J Bone Jt Surg Am, 91, 2137, 10.2106/JBJS.H.01481
Ruiz-Canela, 2000, Intention to treat analysis is related to methodological quality, Br Med J, 320, 1007, 10.1136/bmj.320.7240.1007
Altman, 2009, Missing outcomes in randomised trials: addressing the dilemma, Open Med, 3, e21
Wood, 2004, Are missing outcome data adequately handled? A review of published randomized controlled trials in major medical journals, Clin Trials, 1, 368, 10.1191/1740774504cn032oa
Streiner, 2008, Missing data and the trouble with LOCF, Evid Based Ment Health, 11, 3, 10.1136/ebmh.11.1.3-a
Molnar, 2008, Does analysis using "last observation carried forward" introduce bias in dementia research?, CMAJ, 179, 751, 10.1503/cmaj.080820
Ware, 2003, Interpreting incomplete data in studies of diet and weight loss, N Engl J Med, 348, 2136, 10.1056/NEJMe030054
Streiner, 2002, The case of the missing data: methods of dealing with dropouts and other research vagaries, Can J Psychiatry, 47, 68, 10.1177/070674370204700111
Lane, 2008, Handling drop-out in longitudinal clinical trials: a comparison of the LOCF and MMRM approaches, Pharm Stat, 7, 93, 10.1002/pst.267
Abraha, 2007
Altman, 2000, Confidence intervals in practice, 6
van Linschoten, 2009, Supervised exercise therapy versus usual care for patellofemoral pain syndrome: an open label randomised controlled trial, Br Med J, 339, b4074, 10.1136/bmj.b4074
Altman, 2000, Clinical trials and meta-analyses, 120
1997, Uniform requirements for manuscripts submitted to biomedical journals. International Committee of Medical Journal Editors, Ann Intern Med, 126, 36, 10.7326/0003-4819-126-1-199701010-00006
Gardner, 1986, Confidence intervals rather than P values: estimation rather than hypothesis testing, Br Med J, 292, 746, 10.1136/bmj.292.6522.746
Bailar, 1988, Guidelines for statistical reporting in articles for medical journals. Amplifications and explanations, Ann Intern Med, 108, 266, 10.7326/0003-4819-108-2-266
Bland, 1997, Quoting intermediate analyses can only mislead, Br Med J, 314, 1907, 10.1136/bmj.314.7098.1907a
Cook, 1995, The number needed to treat: a clinically useful measure of treatment effect, Br Med J, 310, 452, 10.1136/bmj.310.6977.452
Altman, 1999, Calculating the number needed to treat for trials where the outcome is time to an event, Br Med J, 319, 1492, 10.1136/bmj.319.7223.1492
1992, Early versus delayed neonatal administration of a synthetic surfactant—the judgment of OSIRIS (open study of infants at high risk of or with respiratory insufficiency—the role of surfactant), Lancet, 340, 1363, 10.1016/0140-6736(92)92557-V
Sorensen, 2008, Laypersons’ understanding of relative risk reductions: randomised cross-sectional study, BMC Med Inform Decis Mak, 8, 31, 10.1186/1472-6947-8-31
Bobbio, 1994, Completeness of reporting trial results: effect on physicians’ willingness to prescribe, Lancet, 343, 1209, 10.1016/S0140-6736(94)92407-4
Naylor, 1992, Measured enthusiasm: does the method of reporting trial results alter perceptions of therapeutic effectiveness?, Ann Intern Med, 117, 916, 10.7326/0003-4819-117-11-916
Tukey, 1977, Some thoughts on clinical trials, especially problems of multiplicity, Science, 198, 679, 10.1126/science.333584
Yusuf, 1991, Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials, J Am Med Assoc, 266, 93, 10.1001/jama.1991.03470010097038
Hahn, 2000, Assessing the potential for bias in meta-analysis due to selective reporting of subgroup analyses within studies, Stat Med, 19, 3325, 10.1002/1097-0258(20001230)19:24<3325::AID-SIM827>3.0.CO;2-D
Bhandari, 2006, Misuse of baseline comparison tests and subgroup analyses in surgical trials, Clin Orthop Relat Res, 447, 247, 10.1097/01.blo.0000218736.23506.fe
Levin, 2000, Recombinant bactericidal/permeability-increasing protein (rBPI21) as adjunctive treatment for children with severe meningococcal sepsis: a randomised trial. rBPI21 Meningococcal Sepsis Study Group, Lancet, 356, 961, 10.1016/S0140-6736(00)02712-4
Scharf, 2006, Adverse event reporting in publications compared with sponsor database for cancer clinical trials, J Clin Oncol, 24, 3933, 10.1200/JCO.2005.05.3959
Pitrou, 2009, Reporting of safety results in published reports of randomized controlled trials, Arch Intern Med, 169, 1756, 10.1001/archinternmed.2009.306
Boden, 2007, Optimal medical therapy with or without PCI for stable coronary disease, N Engl J Med, 356, 1503, 10.1056/NEJMoa070829
Horton, 1995, The rhetoric of research, Br Med J, 310, 985, 10.1136/bmj.310.6985.985
Annals of Internal Medicine, 2008
Docherty, 1999, The case for structuring the discussion of scientific papers, Br Med J, 318, 1224, 10.1136/bmj.318.7193.1224
Purcell, 1998, Changes to manuscripts during the editorial process: characterizing the evolution of a clinical paper, J Am Med Assoc, 280, 227, 10.1001/jama.280.3.227
Ioannidis, 2007, Limitations are not properly acknowledged in the scientific literature, J Clin Epidemiol, 60, 324, 10.1016/j.jclinepi.2006.09.011
Kiviluoto, 1998, Randomised trial of laparoscopic versus open cholecystectomy for acute and gangrenous cholecystitis, Lancet, 351, 321, 10.1016/S0140-6736(97)08447-X
Hupperets, 2009, Effect of unsupervised home based proprioceptive training on recurrences of ankle sprain: randomised controlled trial, Br Med J, 339, b2684, 10.1136/bmj.b2684
Garber, 2009, Prevention of depression in at-risk adolescents: a randomized controlled trial, J Am Med Assoc, 301, 2215, 10.1001/jama.2009.788
Campbell, 1957, Factors relevant to the validity of experiments in social settings, Psychol Bull, 54, 297, 10.1037/h0040950
Rothwell, 2006, Factors that can affect the external validity of randomised controlled trials, PLoS Clin Trials, 1, e9, 10.1371/journal.pctr.0010009
King, 2005, Conceptual framework and systematic review of the effects of participants’ and professionals’ preferences in randomised controlled trials, Health Technol Assess, 9, 1, 10.3310/hta9350
Djulbegovic, 2000, The uncertainty principle and industry-sponsored research, Lancet, 356, 635, 10.1016/S0140-6736(00)02605-2
Dans, 1998, Users’ guides to the medical literature: XIV. How to decide on the applicability of clinical trial results to your patient. Evidence-Based Medicine Working Group, J Am Med Assoc, 279, 545, 10.1001/jama.279.7.545
Smith, 1994, Who benefits from medical interventions?, Br Med J, 308, 72, 10.1136/bmj.308.6921.72
McAlister, 2001, Applying the results of systematic reviews at the bedside
Bartlett, 2005, The causes and effects of socio-demographic exclusions from clinical trials, Health Technol Assess, 9, 1
Bonell, 2006, Assessment of generalisability in trials of health interventions: suggested framework and systematic review, Br Med J, 333, 346, 10.1136/bmj.333.7563.346
Bornhöft, 2006, Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity, BMC Med Res Methodol, 6, 56, 10.1186/1471-2288-6-56
Laupacis, 1988, An assessment of clinically useful measures of the consequences of treatment, N Engl J Med, 318, 1728, 10.1056/NEJM198806303182605
Altman, 1998, Confidence intervals for the number needed to treat, Br Med J, 317, 1309, 10.1136/bmj.317.7168.1309
Fanaroff, 1994, A controlled trial of intravenous immune globulin to reduce nosocomial infections in very-low-birth-weight infants. National Institute of Child Health and Human Development Neonatal Research Network, N Engl J Med, 330, 1107, 10.1056/NEJM199404213301602
1986, Randomised trial of intravenous atenolol among 16 027 cases of suspected acute myocardial infarction: ISIS-1. First International Study of Infarct Survival Collaborative Group, Lancet, 2, 57
Gøtzsche, 1995, Somatostatin v placebo in bleeding oesophageal varices: randomised trial and meta-analysis, Br Med J, 310, 1495, 10.1136/bmj.310.6993.1495
Clarke, 2007, Reports of clinical trials should begin and end with up-to-date systematic reviews of other relevant evidence: a status report, J R Soc Med, 100, 187, 10.1258/jrsm.100.4.187
Goodman, 1999, Toward evidence-based medical statistics. 1: the P value fallacy, Ann Intern Med, 130, 995, 10.7326/0003-4819-130-12-199906150-00008
Gøtzsche, 1987, Reference bias in reports of drug trials, Br Med J, 295, 654, 10.1136/bmj.295.6599.654
Papp, 2008, Efficacy of ISA247 in plaque psoriasis: a randomised, multicentre, double-blind, placebo-controlled phase III study, Lancet, 371, 1337, 10.1016/S0140-6736(08)60593-0
Dickersin, 1997, How important is publication bias? A synthesis of available data, AIDS Educ Prev, 9, 15
Song, 2000, Publication and related biases, Health Technol Assess, 4, 1, 10.3310/hta4100
Williamson, 2005, Identification and impact of outcome selection bias in meta-analysis, Stat Med, 24, 1547, 10.1002/sim.2025
Tramèr, 1997, Impact of covert duplicate publication on meta-analysis: a case study, Br Med J, 315, 635, 10.1136/bmj.315.7109.635
Simes, 1986, Publication bias: the case for an international registry of clinical trials, J Clin Oncol, 4, 1529, 10.1200/JCO.1986.4.10.1529
Chalmers, 2006, From optimism to disillusion about commitment to transparency in the medico-industrial complex, J R Soc Med, 99, 337, 10.1258/jrsm.99.7.337
Tonks, 2002, A clinical trials register for Europe, Br Med J, 325, 1314, 10.1136/bmj.325.7376.1314
Dickersin, 2003, Registering clinical trials, J Am Med Assoc, 290, 516, 10.1001/jama.290.4.516
Whittington, 2004, Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data, Lancet, 363, 1341, 10.1016/S0140-6736(04)16043-1
De Angelis, 2005, Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors, Lancet, 365, 1827, 10.1016/S0140-6736(05)66588-9
Zarin, 2007, Issues in the registration of clinical trials, J Am Med Assoc, 297, 2112, 10.1001/jama.297.19.2112
Hopewell, 2008, Endorsement of the CONSORT Statement by high impact factor medical journals: a survey of journal editors and journal ‘instructions to authors, Trials, 9, 20, 10.1186/1745-6215-9-20
Russell, 2008, Vasopressin versus norepinephrine infusion in patients with septic shock, N Engl J Med, 358, 877, 10.1056/NEJMoa067373
Chan, 2008, The SPIRIT initiative: defining standard protocol items for randomised trials. Oral presentation at the 16th Cochrane Colloquium: evidence in the era of globalisation; 2008 Oct 3–7; Freiburg, Germany, Z Evidenz, Fortbildung Qualitat im Gesundheitswesen, 102, 27
Gregson, 2007, Impact and process evaluation of integrated community and clinic-based HIV-1 control: a cluster-randomised trial in eastern Zimbabwe, PLoS Med, 4, e102, 10.1371/journal.pmed.0040102
Shaddy, 2007, Carvedilol for children and adolescents with heart failure: a randomized controlled trial, J Am Med Assoc, 298, 1171, 10.1001/jama.298.10.1171
Lexchin, 2003, Pharmaceutical industry sponsorship and research outcome and quality: systematic review, Br Med J, 326, 1167, 10.1136/bmj.326.7400.1167
Kjaergard, 2002, Association between competing interests and authors’ conclusions: epidemiological study of randomised clinical trials published in the BMJ, Br Med J, 325, 249, 10.1136/bmj.325.7358.249
Bero, 2007, Factors associated with findings of published trials of drug-drug comparisons: why some statins appear more efficacious than others, PLoS Med, 4, e184, 10.1371/journal.pmed.0040184
Sismondo, 2008, Pharmaceutical company funding and its consequences: a qualitative systematic review, Contemp Clin Trials, 29, 109, 10.1016/j.cct.2007.08.001
Als-Nielsen, 2003, Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events?, J Am Med Assoc, 290, 921, 10.1001/jama.290.7.921
Ross, 2008, Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation, J Am Med Assoc, 299, 1800, 10.1001/jama.299.15.1800
McAlister, 2003, Analysis and reporting of factorial trials: a systematic review, J Am Med Assoc, 289, 2545, 10.1001/jama.289.19.2545
Senn, 2002
Deeks, 2003, Evaluating non-randomised intervention studies, Health Technol Assess, 7, 173
Kunz, 2007, Randomisation to protect against selection bias in healthcare trials, Cochrane Database Syst Rev, 10.1002/14651858.MR000012.pub2
Collins, 2001, Reliable assessment of the effects of treatment on mortality and major morbidity, I: clinical trials, Lancet, 357, 373, 10.1016/S0140-6736(00)03651-5
Schulz, 1996, Randomised trials, human nature, and reporting guidelines, Lancet, 348, 596, 10.1016/S0140-6736(96)01201-9
Murray, 2000, Promoting good research practice, Stat Methods Med Res, 9, 17, 10.1191/096228000670253839
Narahari, 2008, Evidence-based approaches for the Ayurvedic traditional herbal formulations: toward an Ayurvedic CONSORT model, J Altern Complement Med, 14, 769, 10.1089/acm.2007.0818
Bossuyt, 2003, Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD Initiative, Ann Intern Med, 138, 40, 10.7326/0003-4819-138-1-200301070-00010
von Elm, 2007, The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies, Ann Intern Med, 147, 573, 10.7326/0003-4819-147-8-200710160-00010
Tonino, 2009, Fractional flow reserve versus angiography for guiding percutaneous coronary intervention, N Engl J Med, 360, 213, 10.1056/NEJMoa0807611