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Volumn 7, Issue 7, 2012, Pages

Participant informed consent in cluster randomized trials: Review

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DATA COLLECTION METHOD; EPIDEMIOLOGICAL DATA; ETHICAL DECISION MAKING; HUMAN; INFORMED CONSENT; MEDICAL INFORMATION; PATIENT AUTONOMY; PATIENT DECISION MAKING; PATIENT EDUCATION; PATIENT INFORMATION; PATIENT PARTICIPATION; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIAL (TOPIC); SYSTEMATIC REVIEW;

EID: 84863653121     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0040436     Document Type: Article
Times cited : (33)

References (32)
  • 1
    • 0003774549 scopus 로고    scopus 로고
    • Design and Analysis of Cluster Randomization Trials in Health Research
    • Donner A, Klar N, (2000) Design and Analysis of Cluster Randomization Trials in Health Research. London: Arnold.
    • (2000) London: Arnold
    • Donner, A.1    Klar, N.2
  • 2
    • 0032901932 scopus 로고    scopus 로고
    • Methods for evaluating area-wide and organisation-based interventions in health and health care: a systematic review
    • Ukoumunne OC, Gulliford MC, Chinn S, Sterne JA, Burney PG, (1999) Methods for evaluating area-wide and organisation-based interventions in health and health care: a systematic review. Health Technol Assess 3: iii-92.
    • (1999) Health Technol Assess , vol.3
    • Ukoumunne, O.C.1    Gulliford, M.C.2    Chinn, S.3    Sterne, J.A.4    Burney, P.G.5
  • 3
    • 0035835406 scopus 로고    scopus 로고
    • Contamination in trials: is cluster randomisation the answer?
    • Torgerson DJ, (2001) Contamination in trials: is cluster randomisation the answer? BMJ 322: 355-357.
    • (2001) BMJ , vol.322 , pp. 355-357
    • Torgerson, D.J.1
  • 4
    • 0033891962 scopus 로고    scopus 로고
    • Design and analysis issues in cluster-randomized trials of interventions against infectious diseases
    • Hayes RJ, Alexander ND, Bennett S, Cousens SN, (2000) Design and analysis issues in cluster-randomized trials of interventions against infectious diseases. Stat Methods Med Res 9: 95-116.
    • (2000) Stat Methods Med Res , vol.9 , pp. 95-116
    • Hayes, R.J.1    Alexander, N.D.2    Bennett, S.3    Cousens, S.N.4
  • 6
    • 0014115513 scopus 로고
    • Explanatory and pragmatic attitudes in therapeutical trials
    • Schwartz D, Lellouch J, (1967) Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis 20: 637-648.
    • (1967) J Chronic Dis , vol.20 , pp. 637-648
    • Schwartz, D.1    Lellouch, J.2
  • 7
    • 77949650706 scopus 로고    scopus 로고
    • Real-world effectiveness of new medicines should be evaluated by appropriately designed clinical trials
    • Freemantle N, Strack T, (2010) Real-world effectiveness of new medicines should be evaluated by appropriately designed clinical trials. J Clin Epidemiol 63: 1053-1058.
    • (2010) J Clin Epidemiol , vol.63 , pp. 1053-1058
    • Freemantle, N.1    Strack, T.2
  • 8
    • 4844227979 scopus 로고    scopus 로고
    • Cluster randomised trials in the medical literature: two bibliometric surveys
    • Bland JM, (2004) Cluster randomised trials in the medical literature: two bibliometric surveys. BMC Med Res Methodol 4: 21.
    • (2004) BMC Med Res Methodol , vol.4 , pp. 21
    • Bland, J.M.1
  • 9
    • 1642400145 scopus 로고    scopus 로고
    • CONSORT statement: extension to cluster randomised trials
    • Campbell MK, Elbourne DR, Altman DG, (2004) CONSORT statement: extension to cluster randomised trials. BMJ 328: 702-708.
    • (2004) BMJ , vol.328 , pp. 702-708
    • Campbell, M.K.1    Elbourne, D.R.2    Altman, D.G.3
  • 10
    • 0029855639 scopus 로고    scopus 로고
    • Informed consent in human experimentation before the Nuremberg code
    • Vollmann J, Winau R, (1996) Informed consent in human experimentation before the Nuremberg code. Bmj 313: 1445-1449.
    • (1996) Bmj , vol.313 , pp. 1445-1449
    • Vollmann, J.1    Winau, R.2
  • 12
    • 84874552446 scopus 로고    scopus 로고
    • Council for International Organizations Of Medical Sciences Accessed 2 Dec Available
    • Council for International Organizations Of Medical Sciences.(2011) Accessed 2 Dec Available:http://www.cioms.ch/.
    • (2011)
  • 13
    • 0033594688 scopus 로고    scopus 로고
    • Ethical issues in the design and conduct of cluster randomised controlled trials
    • Edwards SJ, Braunholtz DA, Lilford RJ, Stevens AJ, (1999) Ethical issues in the design and conduct of cluster randomised controlled trials. Bmj 318: 1407-1409.
    • (1999) Bmj , vol.318 , pp. 1407-1409
    • Edwards, S.J.1    Braunholtz, D.A.2    Lilford, R.J.3    Stevens, A.J.4
  • 14
    • 0035866022 scopus 로고    scopus 로고
    • Are distinctive ethical principles required for cluster randomized controlled trials?
    • Hutton JL, (2001) Are distinctive ethical principles required for cluster randomized controlled trials? Stat Med 20: 473-488.
    • (2001) Stat Med , vol.20 , pp. 473-488
    • Hutton, J.L.1
  • 16
    • 76949088989 scopus 로고    scopus 로고
    • Ethical challenges posed by cluster randomization
    • In: John Wiley, Sons I, editors, editor
    • Klar N, Donner A, (2007) Ethical challenges posed by cluster randomization. In: John Wiley, Sons I, editors. editor. Wiley Encyclopedia of Clinical Trials. New York.
    • (2007)
    • Klar, N.1    Donner, A.2
  • 17
    • 70350216042 scopus 로고    scopus 로고
    • Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia
    • Osrin D, Azad K, Fernandez A, Manandhar DS, Mwansambo CW, et al. (2009) Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia. Bull World Health Organ 87: 772-779.
    • (2009) Bull World Health Organ , vol.87 , pp. 772-779
    • Osrin, D.1    Azad, K.2    Fernandez, A.3    Manandhar, D.S.4    Mwansambo, C.W.5
  • 18
    • 66349109001 scopus 로고    scopus 로고
    • Preventing bias in cluster randomised trials
    • Giraudeau B, Ravaud P, (2009) Preventing bias in cluster randomised trials. PLoS Med 6: e1000065.
    • (2009) PLoS Med , vol.6
    • Giraudeau, B.1    Ravaud, P.2
  • 19
    • 85006575394 scopus 로고    scopus 로고
    • Designing randomised trials in health, education and the social sciences
    • New York: Palgrave Macmillan
    • Torgerson DJ, Torgerson CJ, (2008) Designing randomised trials in health, education and the social sciences. An introduction. New York: Palgrave Macmillan.
    • (2008) An introduction
    • Torgerson, D.J.1    Torgerson, C.J.2
  • 20
    • 18344367627 scopus 로고    scopus 로고
    • Informed patient consent to participation in cluster randomized trials: an empirical exploration of trials in primary care
    • Eldridge SM, Ashby D, Feder GS, (2005) Informed patient consent to participation in cluster randomized trials: an empirical exploration of trials in primary care. Clin Trials 2: 91-98.
    • (2005) Clin Trials , vol.2 , pp. 91-98
    • Eldridge, S.M.1    Ashby, D.2    Feder, G.S.3
  • 21
    • 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, Dechartres A, Sackett DL, et al. (2006) Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: a systematic review. PLoS Med 3: e425.
    • (2006) PLoS Med , vol.3
    • Boutron, I.1    Estellat, C.2    Guittet, L.3    Dechartres, A.4    Sackett, D.L.5
  • 22
    • 33847658810 scopus 로고    scopus 로고
    • Reporting methods of blinding in randomized trials assessing nonpharmacological treatments
    • Boutron I, Guittet L, Estellat C, Moher D, Hrobjartsson A, et al. (2007) Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med 4: e61.
    • (2007) PLoS Med , vol.4
    • Boutron, I.1    Guittet, L.2    Estellat, C.3    Moher, D.4    Hrobjartsson, A.5
  • 23
    • 84859000091 scopus 로고    scopus 로고
    • Inadequate reporting of research ethics review and informed consent in cluster randomised trials: review of random sample of published trials
    • Taljaard M, McRae AD, Weijer C, Bennett C, Dixon S, et al. (2011) Inadequate reporting of research ethics review and informed consent in cluster randomised trials: review of random sample of published trials. BMJ 342: d2496.
    • (2011) BMJ , vol.342
    • Taljaard, M.1    McRae, A.D.2    Weijer, C.3    Bennett, C.4    Dixon, S.5
  • 24
    • 0141639672 scopus 로고    scopus 로고
    • Evidence for risk of bias in cluster randomised trials: review of recent trials published in three general medical journals
    • Puffer S, Torgerson D, Watson J, (2003) Evidence for risk of bias in cluster randomised trials: review of recent trials published in three general medical journals. Bmj 327: 785-789.
    • (2003) Bmj , vol.327 , pp. 785-789
    • Puffer, S.1    Torgerson, D.2    Watson, J.3
  • 25
    • 80052601465 scopus 로고    scopus 로고
    • When is informed consent required in cluster randomized trials in health research?
    • McRae AD, Weijer C, Binik A, Grimshaw JM, Boruch R, et al. (2011) When is informed consent required in cluster randomized trials in health research? Trials 12: 202.
    • (2011) Trials , vol.12 , pp. 202
    • McRae, A.D.1    Weijer, C.2    Binik, A.3    Grimshaw, J.M.4    Boruch, R.5
  • 26
    • 0034737962 scopus 로고    scopus 로고
    • What makes clinical research ethical?
    • Emanuel EJ, Wendler D, Grady C, (2000) What makes clinical research ethical? JAMA 283: 2701-2711.
    • (2000) JAMA , vol.283 , pp. 2701-2711
    • Emanuel, E.J.1    Wendler, D.2    Grady, C.3
  • 28
    • 68949209179 scopus 로고    scopus 로고
    • Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study
    • Taljaard M, Weijer C, Grimshaw JM, Belle Brown J, Binik A, et al. (2009) Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study. Trials 10: 61.
    • (2009) Trials , vol.10 , pp. 61
    • Taljaard, M.1    Weijer, C.2    Grimshaw, J.M.3    Belle, B.J.4    Binik, A.5
  • 30
    • 80052847587 scopus 로고    scopus 로고
    • Reforming the regulations governing research with human subjects
    • Emanuel EJ, Menikoff J, (2011) Reforming the regulations governing research with human subjects. N Engl J Med 365: 1145-1150.
    • (2011) N Engl J Med , vol.365 , pp. 1145-1150
    • Emanuel, E.J.1    Menikoff, J.2
  • 31
    • 0036698254 scopus 로고    scopus 로고
    • Discrepancy between published report and actual conduct of randomized clinical trials
    • Hill CL, LaValley MP, Felson DT, (2002) Discrepancy between published report and actual conduct of randomized clinical trials. J Clin Epidemiol 55: 783-786.
    • (2002) J Clin Epidemiol , vol.55 , pp. 783-786
    • Hill, C.L.1    LaValley, M.P.2    Felson, D.T.3
  • 32
    • 0346688601 scopus 로고    scopus 로고
    • Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group
    • Soares HP, Daniels S, Kumar A, Clarke M, Scott C, et al. (2004) Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group. BMJ 328: 22-24.
    • (2004) BMJ , vol.328 , pp. 22-24
    • Soares, H.P.1    Daniels, S.2    Kumar, A.3    Clarke, M.4    Scott, C.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.