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General
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Ethical issues
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Randomization
- General
- Allocation Concealment
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Pildal J, Chan AW, Hrobjartsson A, et al. Comparison of descriptions of
allocation concealment in trial protocols and the published reports: cohort
study. BMJ 2005;330:1049
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Hewitt C, Hahn S, Torgerson DJ, et al. Adequacy and reporting of allocation
concealment: review of recent trials published in four general medical journals.
BMJ 2005;330:1057-8.
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Forder PM, Gebski VJ, Keech AC.
Allocation concealment and blinding: when ignorance is
bliss. Med J Aust 2005;182:87-9
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Schulz KF, Grimes DA. Allocation concealment in
randomised trials: defending against deciphering. Lancet 2002;359:614-8
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Altman DG, Schulz KF. Statistics notes: Concealing treatment allocation in
randomised trials. BMJ 2001;323:446-7.
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Schulz
KF. Assessing allocation concealment and blinding in randomized controlled
trials: why bother? Evidence-Based Medicine [EBM Notebook] 2000;5:36-7
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Haynes
RB. Incorporating allocation concealment and blinding in randomized controlled
trials. Evidence-Based Medicine [EBM Notebook] 2000;5:38
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Roberts
C, Torgerson D. Randomisation methods: concealment. BMJ 1999;319:375-6
- Others
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Sample size
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Blinding
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Boutron I, Estellat C, Guittet L, et al. Methods of
blinding in reports of randomized controlled trials
assessing pharmacologic treatments: a systematic review.
PLoS Med 2006;3:e425
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Forder PM, Gebski VJ, Keech AC.
Allocation concealment and blinding: when ignorance is
bliss. Med J Aust 2005;182:87-9
- Devereaux PJ, Choi PT, El-Dika S, et al. An
observational study found that authors of randomized controlled trials
frequently use concealment of randomization and blinding, despite the
failure to report these methods. J Clin Epidemiol 2004;57:1232-1236
[abstract]
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Boutron I, Tubach F, Giraudeau B, et al. Blinding was
judged more difficult to achieve and maintain in nonpharmacologic than
pharmacologic trials. J Clin Epidemiol 2004;57:543-50 [abstract]
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Fergusson D, Glass KC, Waring D, et al. Turning a blind eye: the success
of blinding reported in a random sample of randomised, placebo controlled
trials. BMJ 2004;328:432
- Montori VM, Bhandari M, Devereaux PJ, et al. In the
dark: the reporting of blinding status in randomized controlled trials. J
Clin Epidemiol. 2002;55:787-90 [abstract]
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Schulz KF, Grimes DA. Blinding in
randomised trials: hiding who got what. Lancet 2002;359:696-700.
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Schulz KF, Chalmers I, Altman DG. The landscape and lexicon of blinding in
randomized trials. Ann Intern Med 2002;136:254-9
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Devereaux PJ, Manns BJ, Ghali WA, et al.
Physician
interpretations and textbook definitions of blinding terminology in
randomized controlled trials. JAMA 2001;285:2000-3
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Day SJ,
Altman DG. Statistics notes: blinding in clinical trials and other studies. BMJ
2000;321:504
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Meinert
CL. Masked monitoring in clinical trials--blind stupidity? N Engl J Med
1998;338:1381-2
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Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized
clinical trials: is blinding necessary? Control Clin Trials 1996;17:1-12
[abstract]
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Placebo
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End-points
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Surrogate end-point
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Hauptman PJ.
Measurement of end points in heart failure trials: jousting at windmills? Mt
Sinai J Med 2004;71:298-304
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Johnson JR, Williams G, Pazdur R. End points and United States FDA approval of
oncology drugs. J Clin Oncol 2003;21:1404-1411
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Baker SG,
Kramer BS. A perfect correlate does not a surrogate make. BMC Med Res
Methodol 2003;3:16
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Hughes MD. Evaluating surrogate endpoints. Control Clin Trials
2002;23:703-7
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Molenberghs G, Buyse M, Geys H, et al. Statistical challenges in
the evaluation of surrogate endpoints in randomized trials. Control Clin Trials
2002;23:607-25 [abstract]
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De Gruttola VG, Clax P, DeMets DL, et al. Considerations in the
evaluation of surrogate endpoints in clinical trials. summary of a National
Institutes of Health workshop. Control Clin Trials 2001;22:485-502 [abstract]
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Biomarkers Definitions Working Group. Biomarkers
and surrogate endpoints: preferred definitions and conceptual framework. Clin
Pharmacol Ther 2001;69:89-95
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Kuller LH. Clinical trials: surrogate endpoints or
hard endpoints? Am J Cardiol 2001;88(2-A):59E-61E [abstract]
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Kaplan
NM. Should new drugs be used without outcome data? Implications of ALLHAT and ELITE
II. Arch Intern Med 2001;161:511-2
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Fleming TR. Surrogate end points in cardiovascular disease
trials. Am Heart J 2000;139:S193-6.
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Bobbio
M. Gli end point surrogati. It Hearth J 2000;1:877-9
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D’Agostino
Jr RB. Debate: The slippery slope of surrogate outcomes. Curr Control Trials
Cardiovasc Med 2000, 1:76–78
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Demets DL. The role of surrogate outcome measures in evaluating
medical devices. Surgery 2000;128:379-85
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Bucher
HC, Guyatt GH, Cook DJ, et al. Users' Guides to the
Medical Literature: XIX. Applying Clinical Trial Results A. How to Use
an Article Measuring the Effect of an Intervention on Surrogate End Points.
JAMA 1999;282:771-8
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Temple
R. Are surrogate markers adequate to assess cardiovascular disease drugs?
JAMA 1999;282:790-5
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Psaty
BM, Weiss NS, Furberg CD, et al. Surrogate end
points, health outcomes, and the drug-approval process for the treatment
of risk factors for cardiovascular disease. JAMA 1999;282:786-90
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Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being
misled? Ann Intern Med 1996;125:605-13.
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Johnston K. What are surrogate outcome measures and why do
they fail in clinical research? Neuroepidemiology 1999;18:167-73
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Sobel
BE, Furberg CD. Surrogates, semantics, and sensible public policy. Circulation.
1997;95:1661-1663
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Surrogate measures in clinical trials. Lancet 1990;335:261-2
- Composite end-points
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Statistical Significancy and P value
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Class Effect
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Zhou Z, Rahme E, Abrahamowicz M, Tu JV, et al. Effectiveness
of statins for secondary prevention in elderly patients
after acute myocardial infarction: an evaluation of class
effect. CMAJ 2005;172:1187-94.
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Pilote L, Abrahamowicz M, Rodrigues E, et al. Mortality
rates in elderly patients who take different
angiotensin-converting enzyme inhibitors after acute
myocardial infarction: a class effect? Ann Intern Med
2004;141:102-12.
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Antman EM,
Ferguson JJ. Should evidence-based proof of efficacy as defined for a specific
therapeutic agent be extrapolated to encompass a therapeutic class of agents?
Circulation 2003;108:2604-7
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Furberg CD,
Psaty BM. Should evidence-based proof of drug efficacy be extrapolated to a
"class of agents"? Circulation 2003;108:2608-2610
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Kereiakes
DJ, Willerson JT. Therapeutic substitution: guilty until proven innocent
Circulation 2003;108:2611-2612
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Brown MJ. A rational basis for selection among drugs of the
same class. Heart 2003;89:687-94.
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Kennedy HL, Rosenson RS. Physicians' interpretation of
"class effects": a need for thoughtful re-evaluation. J Am
Coll Cardiol. 2002;40:19-26.
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McAlister FA, Sackett DL. Active-control equivalence trials
and antihypertensive agents. Am J Med 2001;111:553-8.
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Furberg
CD. Class effects and evidence-based medicine. Clin Cardiol 2000;23(7 Suppl
4):IV15-9
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McAlister FA, Laupacis A, Wells GA, et al. Users' Guides to
the Medical Literature: XIX. Applying clinical trial results
B. Guidelines for determining whether a drug is exerting
(more than) a class effect. JAMA 1999;282:1371-7.
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Furberg CD, Herrington DM, Psaty BM. Are drugs within a
class interchangeable? Lancet 1999;354:1202-4.
- Kessler DA, Rose JL, Temple RJ, et al.
Therapeutic-class wars--drug promotion in a competitive
marketplace. N Engl J Med 1994;331:1350-3.
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Intention to Treat
Analysis
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Heritier SR, Gebski VJ, Keech AC. Inclusion of patients in clinical trial
analysis: the intention-to-treat principle. Med J Aust 2003;179:438-40
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Wright CC, Sim J. Intention-to-treat approach to data from
randomized controlled trials: a sensitivity analysis. J Clin Epidemiol
2003;56:833-42 [abstract]
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Kruse
RL, Alper BS, Reust C, et al. Intention-to-treat analysis: who is in? Who is
out? J Fam Pract 2002;51:969-71
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Fergusson
D, Aaron SD, Guyatt G, et al. Post-randomisation exclusions: the intention to
treat principle and excluding patients from analysis. BMJ 2002;325:652-4
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Goetghebeur
E, Loeys T. Beyond intention to treat. Epidemiol Rev 2002;24:85-90
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Montori
VM, Guyatt GH. Intention-to-treat principle. CMAJ 2001;165:1339-41
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Ruiz-Canela M, Martinez-Gonzalez MA, de Irala-Estevez J. Intention to treat
analysis is related to methodological quality. BMJ 2000;320:1007-8.
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Hollis
S, Campbell F. What is meant by intention to treat analysis? Survey of
published randomised controlled trials. BMJ 1999;319:670-4
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Subgroup Analysis
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Lagakos SW. The challenge of subgroup analyses--reporting without distorting. N
Engl J Med 2006;354:1667-9.
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Parker AB, Naylor CD. Interpretation of subgroup results
in clinical trial publications: insights from a survey
of medical specialists in Ontario, Canada. Am Heart J
2006;151:580-8.
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Hernandez AV, Boersma E, Murray GD, et al. Subgroup
analyses in therapeutic cardiovascular clinical trials:
are most of them misleading? Am Heart J 2006;151:257-64.
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Rothwell PM. Subgroup analysis in randomised
controlled trials: importance, indications, and
interpretation. Lancet 2005;365:176-86
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Schulz KF, Grimes DA. Multiplicity in randomised trials II:
subgroup and interim analyses. Lancet 2005;365:1657-61
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Rothwell PM, Mehta Z, Howard SC, et al. 3. From
subgroups to individuals: general principles and the
example of carotid endarterectomy. Lancet
2005;365:256-65
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Simes RJ, Gebski VJ, Keech AC. Subgroup analysis: application to individual
patient decisions. Med J Aust 2004;180:467-9
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Brookes ST, Whitely E, Egger M, et al. Subgroup analyses in
randomized trials: risks of subgroup-specific analyses; power and sample size
for the interaction test. J Clin Epidemiol 2004;57:229-36
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Cook DI, Gebski VJ, Keech AC. Subgroup analysis in clinical trials. Med J Aust
2004;180:289-91
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Brookes ST,
Whitley E, Peters TJ, et al. Subgroup analyses in randomised controlled trials:
quantifying the risks of false-positives and false-negatives. Health Technol
Assess 2001;5:1-56
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Freemantle N.
Interpreting the results of secondary end points and subgroup analyses in
clinical trials: should we lock the crazy aunt in the attic? BMJ 2001;322:989-91
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Assmann
SF, Pocock SJ, Enos LE, et al. Subgroup analysis and other (mis)uses of
baseline data in clinical trials. Lancet 2000;355:1064-9
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Parker AB, Naylor CD. Subgroups, treatment effects, and baseline risks: some
lessons from major cardiovascular trials. Am Heart J 2000;139:952-961.
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Adams KF Jr. Post hoc subgroup analysis and the truth of a
clinical trial. Am Heart J 1998;136:753-8
-
Detsky
AS, Naglie IG. Subgroup analyses: primary and secondary. ACP J Club
1995;122(3):A12-A14
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Oxman AD, Guyatt GH. A consumer's guide to subgroup analyses. Ann
Intern Med 1992;116:78-84 [abstract]
- Yusuf S, Wittes J, Probstfield J, Tyroler HA. Analysis and
interpretation of treatment effects in subgroups of patients in randomized
clinical trials. JAMA 1991;266:93-8 [abstract]
- Bulpitt CJ. Subgroup analysis. Lancet 1988;ii:31-4.
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CONSORT Statement
- Extensions of CONSORT
Statement
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Piaggio G, Elbourne DR, Altman DG, et al; CONSORT Group. Reporting of
noninferiority and equivalence randomized trials: an extension of the CONSORT
statement. JAMA 2006;295:1152-60.
-
Gagnier JJ, Boon H, Rochon P, et al; CONSORT Group. Reporting randomized,
controlled trials of herbal interventions: an elaborated CONSORT statement.
Ann Intern Med 2006;144:364-7.
-
Ioannidis JP, Evans SJ, Gotzsche PC, et al; CONSORT Group. Better reporting of
harms in randomized trials: an extension of the CONSORT statement. Ann Intern
Med 2004;141:781-8.
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Campbell MK, Elbourne DR, Altman DG; CONSORT group. CONSORT statement:
extension to cluster randomised trials. BMJ 2004;328:702-8.
- CONSORT Statement
implementation
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Comments
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General
- Internal validity
- Analysis of results
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Applicability
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General
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Rothwell PM. Factors that can affect the external validity of randomised
controlled trials. PLoS Clin Trials 2006;1:e9.
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Bonell C, Oakley A, Hargreaves J, et al. Assessment of
generalisability in trials of health interventions:
suggested framework and systematic review. BMJ
2006;333:346-9.
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Thompson SG, Higgins JP. Treating Individuals 4. Can meta-analysis help
target interventions at individuals most likely to
benefit? Lancet 2005;365:341-6
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Rothwell PM. Treating individuals 1. External validity of randomised
controlled trials: "to whom do the results of this trial
apply?". Lancet 2005;365:82-93
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Summerskill W. Evidence-based practice
and the individual. Lancet 2005;365:13-4
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Senn S. Individual response to treatment: is it a valid
assumption? BMJ 2004;329:966-8.
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Simes RJ, Gebski VJ, Keech AC. Subgroup analysis:
application to individual patient decisions. Med J Aust
2004;180:467-9
McAlister FA. Applying evidence to patient care: from black and
white to shades of grey. Ann Intern Med 2003;138:938-9
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Are
my patients like this? Bandolier 2002
Straus
SE, McAlister F. Applying the results of trials and systematic reviews
to our individual patients. Evid Based Ment Health 2001 4: 6-7
Doust JA, Silagy CA. Applying the
results of a systematic review in general practice. Med J Aust
2000;172:153-6 [abstract]
-
McAlister FA, Straus SE, Guyatt GH, et al. Users' guides to the medical
literature: XX. Integrating research evidence with the care of the individual
patient. Evidence-Based Medicine Working Group. JAMA 2000;283:2829-36.
-
Rosser
WW. Application of evidence from randomized controlled trials to general
practice. Lancet 1999;353:661-4
-
Mant D. Can randomised trials inform clinical decisions about individual
patients? Lancet 1999;353:743-6
-
Straus SE, Sackett DL. Applying evidence to the individual
patient. Ann Oncol 1999;10:29-32
-
Britton A, McKee M, Black N, et al. Threats to applicability of
randomised trials: exclusions and selective participation. J
Health Serv Res Policy 1999;4:112-21 [abstract]
-
Glasziou P, Guyatt GH, Dans AL,et
al. Applying the results of trials and systematic reviews to individual
patients. ACP J Club 1998;129(3):A15-A16
-
Ross JM. Commentary on applying the results of trials and
systematic reviews to individual patients. ACP J Club 1998;129(3):A17
-
Godlee F. Applying research evidence to individual patients.
Evidence based case reports will help. BMJ 1998;316:1621-1622
-
Dans
AL, Dans LF, Guyatt GH, Richardson S. Users' guides to the medical literature:
XIV. How to decide on the applicability of clinical trial results to your
patient. JAMA 1998;27;279:545-9
-
Fahey T. Applying the results of clinical trials to
patients to general practice: perceived problems, strengths, assumptions,
and challenges for the future. Br J Gen Pract 1998;48:1173-8
Sullivan FM, MacNaughton RJ. Evidence in consultations:
interpreted and individualised. Lancet 1996;348:941-3
-
Glasziou P, Irwig L. An evidence based approach to individualising
patient treatment. BMJ 1995;311:1356-9
-
Rothwell PM. Can overall results of clinical trials be applied
to all patients? Lancet 1995;345:1616-9 [abstract]
- Diseases specific
Jackson R, Lawes CM, Bennett DA, et al. Treating
Individuals 5. Treatment with
drugs to lower blood pressure and blood cholesterol
based on an individual's absolute cardiovascular risk.
Lancet 2005;365:434-41
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Rothwell PM, Mehta Z, Howard SC, et al. Treating
individuals 3. From
subgroups to individuals: general principles and the
example of carotid endarterectomy. Lancet
2005;365:256-65
Rathore SS, Weinfurt KP, Gross CP,et al. Validity
of a simple ST-elevation acute myocardial infarction risk index:
are randomized trial prognostic estimates generalizable to
elderly patients? Circulation 2003;107:811-6
Evans A, Kalra L. Are the results of randomized controlled
trials on anticoagulation in patients with atrial fibrillation
generalizable to clinical practice? Arch Intern Med
2001;161:1443-7
Pignone M, Mulrow CD. Evidence based management of hypertension:
Using cardiovascular risk profiles to individualise hypertensive
treatment. BMJ 2001;322:1164-6
Cook
DJ, Guyatt GH. Interpreting, integrating, and individualizing
evidence about the prevention of diabetic nephropathy. Ann
Intern Med 1999;131:707-8
Walker PM.
Carotid endarterectomy: applying trial results in clinical
practice. CMAJ 1997;157:693-4
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Acronyms
- Compliance
- Statistic analysis
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Non-inferiority/Equivalence Trials
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Kaul S, Diamond GA. Good enough: a primer on the analysis
and interpretation of noninferiority trials. Ann Intern Med
2006;145:62-9.
-
Gotzsche PC. Lessons from and cautions about noninferiority
and equivalence randomized trials. JAMA 2006;295:1172-4.
-
Le Henanff A, Giraudeau B, Baron G, et al. Quality of
reporting of noninferiority and equivalence randomized
trials. JAMA 2006;295:1147-51.
-
Piaggio G, Elbourne DR, Altman DG, et al; CONSORT Group.
Reporting of noninferiority and equivalence randomized
trials: an extension of the CONSORT statement. JAMA
2006;295:1152-60.
-
McAlister FA, Sackett DL. Active-control equivalence trials
and antihypertensive agents. Am J Med 2001;111:553-8.
-
Djulbegovic B, Clarke M. Scientific and ethical issues in
equivalence trials. JAMA 2001;285:1206-8.
-
For
and against: Clinical equipoise and not the uncertainty principle is the
moral underpinning of the randomised controlled trial
-
Djulbegovic
B, et al. The uncertainty principle and industry-sponsored
research. Lancet 2000;356:635-8
-
Tramer MR, Reynolds DJ, Moore RA, et al. When placebo
controlled trials are essential and equivalence trials are
inadequate. BMJ 1998;317:875-80.
-
Jones B, Jarvis P, Lewis JA, et al. Trials to
assess equivalence: the importance of rigorous methods. BMJ
1996;313:36-9.
- Interviews
- Open label trials
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