메뉴 건너뛰기




Volumn 16, Issue 1, 2015, Pages

Specifying the target difference in the primary outcome for a randomised controlled trial: Guidance for researchers

Author keywords

Clinically important difference; Guidance; Randomised controlled trial; Sample size; Target difference

Indexed keywords

ARTICLE; CALCULATION; CLINICAL PROTOCOL; HEALTH CARE PLANNING; HEALTH SURVEY; HUMAN; MEDICAL LITERATURE; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; PUBLISHING; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE; SCIENTIST; STUDY DESIGN; BIOASSAY; PROCEDURES; STANDARDS; STATISTICAL ANALYSIS; STATISTICS AND NUMERICAL DATA; TREATMENT OUTCOME;

EID: 84939147784     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-014-0526-8     Document Type: Article
Times cited : (54)

References (33)
  • 1
    • 67650082352 scopus 로고    scopus 로고
    • Reporting of sample size calculation in randomised controlled trials: review
    • Charles P, Giraudeau B, Dechartres A, Baron G, Ravaud P. Reporting of sample size calculation in randomised controlled trials: review. BMJ. 2009;338:b1732.
    • (2009) BMJ , vol.338
    • Charles, P.1    Giraudeau, B.2    Dechartres, A.3    Baron, G.4    Ravaud, P.5
  • 6
    • 84859005232 scopus 로고    scopus 로고
    • Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study
    • Hellum C, Johnsen LG, Storheim K, Nygaard OP, Brox JI, Rossvoll I, et al. Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study. BMJ. 2011;342:d2786.
    • (2011) BMJ , vol.342
    • Hellum, C.1    Johnsen, L.G.2    Storheim, K.3    Nygaard, O.P.4    Brox, J.I.5    Rossvoll, I.6    Ro, M.7    Sandvik, L.8    Grundnes, O.9
  • 8
    • 77953685393 scopus 로고    scopus 로고
    • Current sample size conventions: flaws, harms, and alternatives
    • Bacchetti P. Current sample size conventions: flaws, harms, and alternatives. BMC Med. 2010;8:17.
    • (2010) BMC Med , vol.8 , pp. 17
    • Bacchetti, P.1
  • 9
    • 84875845125 scopus 로고    scopus 로고
    • Sample size determinations in original research protocols for randomised clinical trials submitted to UK research ethics committees: review
    • Clark T, Berger U, Mansmann U. Sample size determinations in original research protocols for randomised clinical trials submitted to UK research ethics committees: review. BMJ. 2013;346:f1135.
    • (2013) BMJ , vol.346
    • Clark, T.1    Berger, U.2    Mansmann, U.3
  • 15
    • 34748883705 scopus 로고    scopus 로고
    • Understanding the minimum clinically important difference: a review of concepts and methods
    • Copay AG, Subach BR, Glassman SD, Polly J, Schuler TC. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J. 2007;7:541-6.
    • (2007) Spine J , vol.7 , pp. 541-546
    • Copay, A.G.1    Subach, B.R.2    Glassman, S.D.3    Polly, J.4    Schuler, T.C.5
  • 17
    • 0036191550 scopus 로고    scopus 로고
    • Many faces of the minimal clinically important difference (MICD): A literature review and directions for future research
    • Beaton DE, Boers M, Wells GA. Many faces of the minimal clinically important difference (MICD): A literature review and directions for future research. Curr Opin Rheumatol. 2002;14:109-14.
    • (2002) Curr Opin Rheumatol , vol.14 , pp. 109-114
    • Beaton, D.E.1    Boers, M.2    Wells, G.A.3
  • 18
    • 0033773461 scopus 로고    scopus 로고
    • The concept of clinically meaningful difference in health-related quality-of-life research. How meaningful is it?
    • Hays RD, Woolley JM. The concept of clinically meaningful difference in health-related quality-of-life research. How meaningful is it? Pharmacoeconomics. 2000;18:419-23.
    • (2000) Pharmacoeconomics , vol.18 , pp. 419-423
    • Hays, R.D.1    Woolley, J.M.2
  • 19
    • 18844409426 scopus 로고    scopus 로고
    • Sufficiently important difference: expanding the framework of clinical significance
    • Barrett B, Brown D, Mundt M, Brown R. Sufficiently important difference: expanding the framework of clinical significance. Med Decis Making. 2005;25:250-61.
    • (2005) Med Decis Making , vol.25 , pp. 250-261
    • Barrett, B.1    Brown, D.2    Mundt, M.3    Brown, R.4
  • 20
    • 77951722695 scopus 로고    scopus 로고
    • Optimal clinical trial design using value of information methods with imperfect implementation
    • Willan AR, Eckermann S. Optimal clinical trial design using value of information methods with imperfect implementation. Health Econ. 2010;19:549-61.
    • (2010) Health Econ , vol.19 , pp. 549-561
    • Willan, A.R.1    Eckermann, S.2
  • 21
    • 38849173686 scopus 로고    scopus 로고
    • A Bayesian cost-benefit approach to the determination of sample size in clinical trials
    • Kikuchi T, Pezeshk H, Gittins J. A Bayesian cost-benefit approach to the determination of sample size in clinical trials. Stat Med. 2008;27:68-82.
    • (2008) Stat Med , vol.27 , pp. 68-82
    • Kikuchi, T.1    Pezeshk, H.2    Gittins, J.3
  • 22
    • 31144463367 scopus 로고    scopus 로고
    • Arbitrary metrics in psychology
    • Blanton H, Jaccard J. Arbitrary metrics in psychology. Am Psychol. 2006;61:27-41.
    • (2006) Am Psychol , vol.61 , pp. 27-41
    • Blanton, H.1    Jaccard, J.2
  • 23
    • 77949965505 scopus 로고    scopus 로고
    • The rise and fall of the "minimum clinically important difference"
    • Carragee EJ. The rise and fall of the "minimum clinically important difference". Spine J. 2010;10:283-4.
    • (2010) Spine J , vol.10 , pp. 283-284
    • Carragee, E.J.1
  • 24
    • 34447539828 scopus 로고    scopus 로고
    • Statistical significance versus clinical importance: trials on exercise therapy for chronic low back pain as example
    • Van TM, Malmivaara A, Hayden J, Koes B. Statistical significance versus clinical importance: trials on exercise therapy for chronic low back pain as example. Spine. 2007;32:1785-90.
    • (2007) Spine , vol.32 , pp. 1785-1790
    • Van, T.M.1    Malmivaara, A.2    Hayden, J.3    Koes, B.4
  • 26
    • 77950189829 scopus 로고    scopus 로고
    • CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials
    • Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332.
    • (2010) BMJ , vol.340
    • Schulz, K.F.1    Altman, D.G.2    Moher, D.3
  • 30
    • 0033774033 scopus 로고    scopus 로고
    • Macular hole surgery with and without internal limiting membrane peeling
    • Brooks Jr HL. Macular hole surgery with and without internal limiting membrane peeling. Ophthalmology. 2000;107:1939-48.
    • (2000) Ophthalmology , vol.107 , pp. 1939-1948
    • Brooks, H.L.1
  • 31
    • 0033498330 scopus 로고    scopus 로고
    • Effect of autologous platelet concentrate in surgery for idiopathic macular hole: results of a multicenter, double-masked, randomized trial. Platelets in Macular Hole Surgery Group
    • Paques M, Chastang C, Mathis A, Sahel J, Massin P, Dosquet C, et al. Effect of autologous platelet concentrate in surgery for idiopathic macular hole: results of a multicenter, double-masked, randomized trial. Platelets in Macular Hole Surgery Group. Ophthalmology. 1999;106:932-8.
    • (1999) Ophthalmology , vol.106 , pp. 932-938
    • Paques, M.1    Chastang, C.2    Mathis, A.3    Sahel, J.4    Massin, P.5    Dosquet, C.6    Korobelnik, J.F.7    Gargasson, J.F.8    Gaudric, A.9
  • 32
    • 33751205161 scopus 로고    scopus 로고
    • Protocol for the Arterial Revascularisation Trial (ART). A randomised trial to compare survival following bilateral versus single internal mammary grafting in coronary revascularisation
    • Taggart DP, Lees B, Gray A, Altman DG, Flather M, Channon K, et al. Protocol for the Arterial Revascularisation Trial (ART). A randomised trial to compare survival following bilateral versus single internal mammary grafting in coronary revascularisation. Trials. 2006;7:7.
    • (2006) Trials , vol.7 , pp. 7
    • Taggart, D.P.1    Lees, B.2    Gray, A.3    Altman, D.G.4    Flather, M.5    Channon, K.6
  • 33
    • 0035883898 scopus 로고    scopus 로고
    • Effect of arterial revascularisation on survival: a systematic review of studies comparing bilateral and single internal mammary arteries
    • Taggart DP, D'Amico R, Altman DG. Effect of arterial revascularisation on survival: a systematic review of studies comparing bilateral and single internal mammary arteries. Lancet. 2001;358:870-5.
    • (2001) Lancet , vol.358 , pp. 870-875
    • Taggart, D.P.1    D'Amico, R.2    Altman, D.G.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.