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Randomization

Altman D.and Bland JM.Treatment allocation in controlled trials: why randomize? BMJ 318:1209,1999.

 

Altman D.and Bland JM. How to randomize. BMJ 319: 703, 1999.

Glasziou P., et. al. When are randomized trials unnecessary? Picking signal from noise. BMJ 334: 349, 20007.

McKee M. et .al. Interpreting the evidence: choosing between randomised and non­randomised studies. BMJ 19:312,1999.

Concealment allocation

Altman D.and Schulz K. Concealing treatment allocation in randomised trials BMJ 323: 446, 2001.

Schulz K. Assessing allocation concealment and blinding in randomised controlled trials: why bother? Evid. Based Med. 5:36, 2000.

Blinding

Boutron I., et. al. Reporting Methods of Blinding in Randomized Trials Assessing Nonpharmacological Treatments.PLoS Medicine: 4: e61, 2007.

Chalmers I. and Altman D. The Landscape and Lexicon of Blinding in Randomized Trials. Annals of Internal Medicine 136: 254, 2002.

DEVEREAUX, P., et. al. Physician Interpretations and Textbook Definitions of Blinding Terminology in Randomized Controlled Trials. JAMA: 285: 2000, 2001.

Boutron I., et. al. Methods of Blinding in Reports of Randomized Controlled Trials Assessing Pharmacologic Treatments: A Systematic Review. PLoS Medicine: 3, e425, 2006.

Intention To Treat Analysis

Hollis S. and Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ 319: 670,1999.

Montori,V. and Guyatt,G. Intention-to-treat principle. CMAJ 165: 1339, 2001.

Altman D.& Bland JM. Missing Data. BMJ 334: 424, 2007.

Fergusson D., et.al. Post randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ 325: 652, 2002.

Results

Lord S., Gebski V. and Keech A. Multiple analyses in clinical trials:sound science or data dredging? MJA 181: 452, 2004.

DOLL H. and CARNEY S. Statistical approaches to uncertainty: p values and confidence intervals unpacked. EBM:133, 2005.

Barratt A., et. al. Tips for teachers of evidence-based medicine: 1. Relative risk reduction, absolute risk reduction and number needed to treat. CMAJ: 171, 2002.

GLASZIOU P. and DOLL H. Was the study big enough? Two cafe´ rules. EBM 11: 69, 2006.

Vickers A. and Altman D. Analysing controlled trials with baseline and follow up

measurements. BMJ 323:1123, 2001.

SUTTON A, et. al. Two knees or one person: data analysis strategies for paired

joints or organs. Annals of the Rheumatic Diseases 56:401, 1997.

 

 

External Validity

Rothwell P. Factors That Can Affect the External Validity of Randomised Controlled Trials. PLoS Clinical trials: e9, 2006.

Revicki D., et., al. Responsiveness and minimal important differences for patient

reported outcomes. BioMed Central Health and Quality of Life Outcomes 4:70, 2006.

Lansdorf K. and Radford J. Minimal important difference: Values for the Foot Health Status Questionnaire, Foot Function Index and Visual Analogue Scale. The Foot 18: 15, 2008.

Martin R., et.,al. Current Concepts Review: Foot and Ankle Outcome Instruments. Foot & Ankle International 27: 383, 2006.

 

Ioannidis, J, et. al. Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement. Ann Intern Med. 141:781, 2004.

Surgery

McCulloch P., et. al. Randomized trials in surgery: problems and possible solutions. BMJ 324:1448, 2002.

Devereaux P., et. al. Need for expertise based randomised controlled trials. BMJ 330: 88, 2005.

Hoppe D. and Bhandari M. Evidence-based Orthopedics: A brief history. IJO 42: 104, 2008.