메뉴 건너뛰기




Volumn 23, Issue 2, 2009, Pages 291-303

How to perform a critical analysis of a randomised controlled trial

Author keywords

bias; evidence based medicine; randomisation; randomised controlled trial; sample size; selection bias

Indexed keywords

ANALYTIC METHOD; CLINICAL STUDY; CONFLICT OF INTEREST; DATA ANALYSIS; EVIDENCE BASED MEDICINE; EXTERNAL VALIDITY; METHODOLOGY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOM SAMPLE; REVIEW; SAMPLE SIZE; SAMPLING; STATISTICAL ANALYSIS; SYSTEMATIC ERROR;

EID: 64749091915     PISSN: 15216942     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.berh.2009.03.003     Document Type: Review
Times cited : (13)

References (32)
  • 1
    • 0027368467 scopus 로고
    • Users' guides to the medical literature. II. How to use an article about therapy or prevention. A. Are the results of the study valid? Evidence-Based Medicine Working Group
    • Guyatt G.H., Sackett D.L., and Cook D.J. Users' guides to the medical literature. II. How to use an article about therapy or prevention. A. Are the results of the study valid? Evidence-Based Medicine Working Group. J Am Med Assoc 270 (1993) 2598-2601
    • (1993) J Am Med Assoc , vol.270 , pp. 2598-2601
    • Guyatt, G.H.1    Sackett, D.L.2    Cook, D.J.3
  • 2
    • 0028047157 scopus 로고
    • Users' guides to the medical literature. II. How to use an article about therapy or prevention. B. What were the results and will they help me in caring for my patients? Evidence-Based Medicine Working Group
    • Guyatt G.H., Sackett D.L., and Cook D.J. Users' guides to the medical literature. II. How to use an article about therapy or prevention. B. What were the results and will they help me in caring for my patients? Evidence-Based Medicine Working Group. J Am Med Assoc 271 (1994) 59-63
    • (1994) J Am Med Assoc , vol.271 , pp. 59-63
    • Guyatt, G.H.1    Sackett, D.L.2    Cook, D.J.3
  • 3
    • 0035906308 scopus 로고    scopus 로고
    • The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials
    • Moher D., Schulz K.F., and Altman D. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. J Am Med Assoc 285 (2001) 1987-1991
    • (2001) J Am Med Assoc , vol.285 , pp. 1987-1991
    • Moher, D.1    Schulz, K.F.2    Altman, D.3
  • 4
    • 0030850011 scopus 로고    scopus 로고
    • Assessing the methodological quality of published papers
    • Greenhalgh T. Assessing the methodological quality of published papers. BMJ 315 (1997) 305-308
    • (1997) BMJ , vol.315 , pp. 305-308
    • Greenhalgh, T.1
  • 5
    • 79955659315 scopus 로고    scopus 로고
    • Kunz R, Vist G, Oxman AD. Randomisation to protect against selection bias in healthcare trials. Cochrane Database Syst Rev 2007, Issue 2. Art No.:MR000012. doi:10.1002/14651858.MR000012.pub2.
    • Kunz R, Vist G, Oxman AD. Randomisation to protect against selection bias in healthcare trials. Cochrane Database Syst Rev 2007, Issue 2. Art No.:MR000012. doi:10.1002/14651858.MR000012.pub2.
  • 6
    • 0036697230 scopus 로고    scopus 로고
    • In the dark: the reporting of blinding status in randomized controlled trials
    • Montori V.M., Bhandari M., Devereaux P.J., et al. In the dark: the reporting of blinding status in randomized controlled trials. J Clin Epidemiol 55 (2002) 787-790
    • (2002) J Clin Epidemiol , vol.55 , pp. 787-790
    • Montori, V.M.1    Bhandari, M.2    Devereaux, P.J.3
  • 7
    • 40949113623 scopus 로고    scopus 로고
    • Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study
    • Wood L., Egger M., Gluud L.L., et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ 336 (2008) 601-605
    • (2008) BMJ , vol.336 , pp. 601-605
    • Wood, L.1    Egger, M.2    Gluud, L.L.3
  • 8
    • 0037160763 scopus 로고    scopus 로고
    • Blinding in randomised trials: hiding who got what
    • Schulz K.F., and Grimes D.A. Blinding in randomised trials: hiding who got what. Lancet 359 (2002) 696-700
    • (2002) Lancet , vol.359 , pp. 696-700
    • Schulz, K.F.1    Grimes, D.A.2
  • 9
    • 33750877515 scopus 로고    scopus 로고
    • Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: a systematic review
    • 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 3 (2006) e425
    • (2006) PLoS Med , vol.3
    • Boutron, I.1    Estellat, C.2    Guittet, L.3
  • 10
    • 33847658810 scopus 로고    scopus 로고
    • Reporting Methods of Blinding in Randomized Trials Assessing Nonpharmacological Treatments
    • Boutron I., Guittet L., Estellat C., et al. Reporting Methods of Blinding in Randomized Trials Assessing Nonpharmacological Treatments. PLoS Med 4 (2007) e61
    • (2007) PLoS Med , vol.4
    • Boutron, I.1    Guittet, L.2    Estellat, C.3
  • 11
    • 0033546995 scopus 로고    scopus 로고
    • What is meant by intention to treat analysis? Survey of published randomised controlled trials
    • Hollis S., and Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ 319 (1999) 670-674
    • (1999) BMJ , vol.319 , pp. 670-674
    • Hollis, S.1    Campbell, F.2
  • 12
    • 0142260954 scopus 로고    scopus 로고
    • Inclusion of patients in clinical trial analysis: the intention-to-treat principle
    • Heritier S.R., Gebski V.J., and Keech A.C. Inclusion of patients in clinical trial analysis: the intention-to-treat principle. Med J Aust 179 (2003) 438-440
    • (2003) Med J Aust , vol.179 , pp. 438-440
    • Heritier, S.R.1    Gebski, V.J.2    Keech, A.C.3
  • 14
    • 20744445181 scopus 로고    scopus 로고
    • Violation of the intent-to-treat principle and rate of missing data in superiority trials assessing structural outcomes in rheumatic diseases
    • Baron G., Boutron I., Giraudeau B., et al. Violation of the intent-to-treat principle and rate of missing data in superiority trials assessing structural outcomes in rheumatic diseases. Arthritis Rheum 52 (2005) 1858-1865
    • (2005) Arthritis Rheum , vol.52 , pp. 1858-1865
    • Baron, G.1    Boutron, I.2    Giraudeau, B.3
  • 15
    • 33751217149 scopus 로고    scopus 로고
    • Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial
    • Weinstein J.N., Tosteson T.D., Lurie J.D., et al. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. J Am Med Assoc 296 (2006) 2441-2450
    • (2006) J Am Med Assoc , vol.296 , pp. 2441-2450
    • Weinstein, J.N.1    Tosteson, T.D.2    Lurie, J.D.3
  • 16
    • 0036170270 scopus 로고    scopus 로고
    • Design and quality considerations for randomized controlled trials in systemic sclerosis
    • Kyriakidi M., and Ioannidis J.P. Design and quality considerations for randomized controlled trials in systemic sclerosis. Arthritis Rheum 47 (2002) 73-81
    • (2002) Arthritis Rheum , vol.47 , pp. 73-81
    • Kyriakidi, M.1    Ioannidis, J.P.2
  • 17
    • 0030268577 scopus 로고    scopus 로고
    • Surrogate end points in clinical trials: are we being misled?
    • Fleming T.R., and DeMets D.L. Surrogate end points in clinical trials: are we being misled?. Ann Intern Med 125 (1996) 605-613
    • (1996) Ann Intern Med , vol.125 , pp. 605-613
    • Fleming, T.R.1    DeMets, D.L.2
  • 18
    • 0025374223 scopus 로고
    • Effect of fluoride treatment on the fracture rate in postmenopausal women with osteoporosis
    • Riggs B.L., Hodgson S.F., O'Fallon W.M., et al. Effect of fluoride treatment on the fracture rate in postmenopausal women with osteoporosis. N Engl J Med 322 (1990) 802-809
    • (1990) N Engl J Med , vol.322 , pp. 802-809
    • Riggs, B.L.1    Hodgson, S.F.2    O'Fallon, W.M.3
  • 19
    • 2442692780 scopus 로고    scopus 로고
    • Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles
    • Chan A.W., Hrobjartsson A., Haahr M.T., et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. J Am Med Assoc 291 (2004) 2457-2465
    • (2004) J Am Med Assoc , vol.291 , pp. 2457-2465
    • Chan, A.W.1    Hrobjartsson, A.2    Haahr, M.T.3
  • 20
    • 11844302840 scopus 로고    scopus 로고
    • Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation
    • Rothwell P.M. Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. Lancet 365 (2005) 176-186
    • (2005) Lancet , vol.365 , pp. 176-186
    • Rothwell, P.M.1
  • 21
    • 0028908929 scopus 로고
    • The number needed to treat: a clinically useful measure of treatment effect
    • Cook R.J., and Sackett D.L. The number needed to treat: a clinically useful measure of treatment effect. BMJ 310 (1995) 452-454
    • (1995) BMJ , vol.310 , pp. 452-454
    • Cook, R.J.1    Sackett, D.L.2
  • 22
    • 0344837332 scopus 로고    scopus 로고
    • Number needed to treat (NNT): implication in rheumatology clinical practice
    • Osiri M., Suarez-Almazor M.E., Wells G.A., et al. Number needed to treat (NNT): implication in rheumatology clinical practice. Ann Rheum Dis 62 (2003) 316-321
    • (2003) Ann Rheum Dis , vol.62 , pp. 316-321
    • Osiri, M.1    Suarez-Almazor, M.E.2    Wells, G.A.3
  • 23
    • 0023887476 scopus 로고
    • An assessment of clinically useful measures of the consequences of treatment
    • Laupacis A., Sackett D.L., and Roberts R.S. An assessment of clinically useful measures of the consequences of treatment. N Engl J Med 318 (1988) 1728-1733
    • (1988) N Engl J Med , vol.318 , pp. 1728-1733
    • Laupacis, A.1    Sackett, D.L.2    Roberts, R.S.3
  • 24
    • 27744435776 scopus 로고    scopus 로고
    • The prevalence of underpowered randomized clinical trials in rheumatology
    • Keen H.I., Pile K., and Hill C.L. The prevalence of underpowered randomized clinical trials in rheumatology. J Rheumatol 32 (2005) 2083-2088
    • (2005) J Rheumatol , vol.32 , pp. 2083-2088
    • Keen, H.I.1    Pile, K.2    Hill, C.L.3
  • 25
    • 38849162727 scopus 로고    scopus 로고
    • In the era of systematic reviews, does the size of an individual trial still matter
    • Guyatt G.H., Mills E.J., and Elbourne D. In the era of systematic reviews, does the size of an individual trial still matter. PLoS Med 5 (2008) e4
    • (2008) PLoS Med , vol.5
    • Guyatt, G.H.1    Mills, E.J.2    Elbourne, D.3
  • 26
    • 0030912322 scopus 로고    scopus 로고
    • Statistics notes. Units of analysis
    • Altman D.G., and Bland J.M. Statistics notes. Units of analysis. BMJ 314 (1997) 1874
    • (1997) BMJ , vol.314 , pp. 1874
    • Altman, D.G.1    Bland, J.M.2
  • 27
    • 0031976495 scopus 로고    scopus 로고
    • Independence and statistical inference in clinical trial designs: a tutorial review
    • Bolton S. Independence and statistical inference in clinical trial designs: a tutorial review. J Clin Pharmacol 38 (1998) 408-412
    • (1998) J Clin Pharmacol , vol.38 , pp. 408-412
    • Bolton, S.1
  • 28
    • 11444261579 scopus 로고    scopus 로고
    • External validity of randomised controlled trials: 'to whom do the results of this trial apply?
    • Rothwell P.M. External validity of randomised controlled trials: 'to whom do the results of this trial apply?. Lancet 365 (2005) 82-93
    • (2005) Lancet , vol.365 , pp. 82-93
    • Rothwell, P.M.1
  • 29
    • 30744460391 scopus 로고    scopus 로고
    • Clinical data gap between phase III clinical trials (pre-marketing) and phase IV (post-marketing) studies: evaluation of etanercept in rheumatoid arthritis
    • Farahani P., Levine M., Gaebel K., et al. Clinical data gap between phase III clinical trials (pre-marketing) and phase IV (post-marketing) studies: evaluation of etanercept in rheumatoid arthritis. Can J Clin Pharmacol 12 (2005) e254-e263
    • (2005) Can J Clin Pharmacol , vol.12
    • Farahani, P.1    Levine, M.2    Gaebel, K.3
  • 30
    • 8744229000 scopus 로고    scopus 로고
    • Better reporting of harms in randomized trials: an extension of the CONSORT statement
    • Ioannidis J.P., Evans S.J., Gotzsche P.C., et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 141 (2004) 781-788
    • (2004) Ann Intern Med , vol.141 , pp. 781-788
    • Ioannidis, J.P.1    Evans, S.J.2    Gotzsche, P.C.3
  • 31
    • 22044434417 scopus 로고    scopus 로고
    • Powering our way to the elusive side effect: a composite outcome 'basket' of predefined designated endpoints in each organ system should be included in all controlled trials
    • Tugwell P., Judd M.G., Fries J.F., et al. Powering our way to the elusive side effect: a composite outcome 'basket' of predefined designated endpoints in each organ system should be included in all controlled trials. J Clin Epidemiol 58 (2005) 785-790
    • (2005) J Clin Epidemiol , vol.58 , pp. 785-790
    • Tugwell, P.1    Judd, M.G.2    Fries, J.F.3
  • 32
    • 0028115828 scopus 로고
    • A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis
    • Rochon P.A., Gurwitz J.H., Simms R.W., et al. A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis. Arch Intern Med 154 (1994) 157-163
    • (1994) Arch Intern Med , vol.154 , pp. 157-163
    • Rochon, P.A.1    Gurwitz, J.H.2    Simms, R.W.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.