메뉴 건너뛰기




Volumn 12, Issue , 2011, Pages

Developing a placebo-controlled trial in surgery: Issues of design, acceptability and feasibility

Author keywords

[No Author keywords available]

Indexed keywords

ANESTHESIST; ARTHROSCOPIC LAVAGE; ARTHROSCOPY; ARTICLE; CLINICAL DECISION MAKING; COST EFFECTIVENESS ANALYSIS; FEASIBILITY STUDY; GENERAL ANESTHESIA; HEALTH PRACTITIONER; HEALTH SURVEY; HUMAN; INTERVIEW; KNEE OSTEOARTHRITIS; LAVAGE; MEDICAL ETHICS; PATIENT ASSESSMENT; PHYSICIAN ATTITUDE; RESEARCH ETHICS; STUDY DESIGN; UNITED KINGDOM; ATTITUDE TO HEALTH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; ETHICS; HEALTH PERSONNEL ATTITUDE; METHODOLOGY; MULTICENTER STUDY; PATIENT ATTITUDE; PATIENT SELECTION; PILOT STUDY; PLACEBO EFFECT; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

EID: 79951696478     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-12-50     Document Type: Article
Times cited : (39)

References (33)
  • 1
    • 70449243257 scopus 로고
    • An evaluation of internal-mammary-artery ligation by a double-blind technic
    • 10.1056/NEJM195905282602204, 13657350
    • Cobb LA, Thomas GI, Dillard DH, Merendino KA, Bruce RA. An evaluation of internal-mammary-artery ligation by a double-blind technic. N Engl J Med 1959, 260:1115-8. 10.1056/NEJM195905282602204, 13657350.
    • (1959) N Engl J Med , vol.260 , pp. 1115-1118
    • Cobb, L.A.1    Thomas, G.I.2    Dillard, D.H.3    Merendino, K.A.4    Bruce, R.A.5
  • 2
    • 0017806832 scopus 로고
    • Double-blind controlled trial of electroconvulsive therapy (ECT) and simulated ECT in depressive illness
    • 10.1016/S0140-6736(78)90857-7, 76748
    • Freeman CPL, Basson JV, Crighton A. Double-blind controlled trial of electroconvulsive therapy (ECT) and simulated ECT in depressive illness. Lancet 1978, 1:738-40. 10.1016/S0140-6736(78)90857-7, 76748.
    • (1978) Lancet , vol.1 , pp. 738-740
    • Freeman, C.P.L.1    Basson, J.V.2    Crighton, A.3
  • 3
    • 0018092960 scopus 로고
    • A controlled comparison of simulated and real ECT
    • Lambourn J, Gill D. A controlled comparison of simulated and real ECT. Br J Psychiat 1978, 133:514-19.
    • (1978) Br J Psychiat , vol.133 , pp. 514-519
    • Lambourn, J.1    Gill, D.2
  • 5
    • 0019382876 scopus 로고
    • Electric convulsion therapy in depression: a double blind controlled trial
    • 10.1136/bmj.282.6261.355, 1504188, 6780021
    • West ED. Electric convulsion therapy in depression: a double blind controlled trial. BMJ 1981, 282:355-7. 10.1136/bmj.282.6261.355, 1504188, 6780021.
    • (1981) BMJ , vol.282 , pp. 355-357
    • West, E.D.1
  • 6
    • 0021949673 scopus 로고
    • The Nottingham ECT study: a double-blind comparison of bilateral, unilateral and simulated ECT in depressive illness
    • Gregory S, Shawcross CR, Gill D. The Nottingham ECT study: a double-blind comparison of bilateral, unilateral and simulated ECT in depressive illness. Br J Psychiat 1985, 146:520-4.
    • (1985) Br J Psychiat , vol.146 , pp. 520-524
    • Gregory, S.1    Shawcross, C.R.2    Gill, D.3
  • 8
    • 0033598429 scopus 로고    scopus 로고
    • Use of placebo-surgery in controlled trials of cellular-based therapy for Parkinson's disease
    • 10.1056/NEJM199909233411311, 10498497
    • Freeman TB, Vawter DE, Leaverton PE, Godbold JH, Hauser RA, Goetz CG, Olanow CW. Use of placebo-surgery in controlled trials of cellular-based therapy for Parkinson's disease. New Engl J Med 1999, 341(13):988-92. 10.1056/NEJM199909233411311, 10498497.
    • (1999) New Engl J Med , vol.341 , Issue.13 , pp. 988-992
    • Freeman, T.B.1    Vawter, D.E.2    Leaverton, P.E.3    Godbold, J.H.4    Hauser, R.A.5    Goetz, C.G.6    Olanow, C.W.7
  • 9
    • 34447291148 scopus 로고    scopus 로고
    • Randomized surgical trials and "sham" surgery: relevance to modern orthopaedics and minimally invasive surgery
    • 1888585, 16789458
    • Wolf B, Buckwalter JA. Randomized surgical trials and "sham" surgery: relevance to modern orthopaedics and minimally invasive surgery. Iowa Orthop J 2006, 26:107-11. 1888585, 16789458.
    • (2006) Iowa Orthop J , vol.26 , pp. 107-111
    • Wolf, B.1    Buckwalter, J.A.2
  • 10
    • 0033598325 scopus 로고    scopus 로고
    • The ethical problems of sham surgery in clinical research
    • 10.1056/NEJM199909233411312, 10498498
    • Macklin R. The ethical problems of sham surgery in clinical research. N Engl J Med 1999, 341:992-6. 10.1056/NEJM199909233411312, 10498498.
    • (1999) N Engl J Med , vol.341 , pp. 992-996
    • Macklin, R.1
  • 11
    • 0036783743 scopus 로고    scopus 로고
    • Placebos that harm: sham surgery controls in clinical trials
    • 10.1191/0962280202sm300ra, 12357587
    • London AJ, Kadane JB. Placebos that harm: sham surgery controls in clinical trials. Stat Methods Med Res 2002, 11:413-27. 10.1191/0962280202sm300ra, 12357587.
    • (2002) Stat Methods Med Res , vol.11 , pp. 413-427
    • London, A.J.1    Kadane, J.B.2
  • 12
    • 75549116122 scopus 로고
    • Factors contributing to the placebo effect. Their implications for psychotherapy
    • Shapiro AK. Factors contributing to the placebo effect. Their implications for psychotherapy. Am J Psychother 1964, 18:73-88.
    • (1964) Am J Psychother , vol.18 , pp. 73-88
    • Shapiro, A.K.1
  • 13
    • 0004190546 scopus 로고
    • Placebos and the philosophy of medicine. Clinical, conceptual and ethical issues
    • Chicago: University of Chicago Press
    • Brody H. Placebos and the philosophy of medicine. Clinical, conceptual and ethical issues. 1980, Chicago: University of Chicago Press.
    • (1980)
    • Brody, H.1
  • 14
    • 0032748751 scopus 로고    scopus 로고
    • Placebos and placebo effects in medicine: historical overview
    • 1297390, 10692902
    • De Craen AJM, Kaptchuk TJ, Tijssen JGP, Kleijnen J. Placebos and placebo effects in medicine: historical overview. J Roy Soc Med 1999, 92:511-5. 1297390, 10692902.
    • (1999) J Roy Soc Med , vol.92 , pp. 511-515
    • De Craen, A.J.M.1    Kaptchuk, T.J.2    Tijssen, J.G.P.3    Kleijnen, J.4
  • 15
    • 76249113603 scopus 로고    scopus 로고
    • The effectiveness and cost-effectiveness of arthroscopic lavage in the treatment of osteoarthritis of the knee: a mixed methods study of the feasibility of conducting a surgical placebo-controlled trial (the KORAL study)
    • for the KORAL study group
    • Campbell MK, Skea ZC, Sutherland AG, Cuthbertson BH, Entwistle VA, McDonald AM, Norrie JD, Carlson R, Bridgman S, . for the KORAL study group The effectiveness and cost-effectiveness of arthroscopic lavage in the treatment of osteoarthritis of the knee: a mixed methods study of the feasibility of conducting a surgical placebo-controlled trial (the KORAL study). Health Technology Assessment 2010, 14:5. for the KORAL study group.
    • (2010) Health Technology Assessment , vol.14 , pp. 5
    • Campbell, M.K.1    Skea, Z.C.2    Sutherland, A.G.3    Cuthbertson, B.H.4    Entwistle, V.A.5    McDonald, A.M.6    Norrie, J.D.7    Carlson, R.8    Bridgman, S.9
  • 18
    • 0036767416 scopus 로고    scopus 로고
    • A controlled trial of arthroscopic surgery for osteoarthritis of the knee [letter]
    • 10.1053/jars.2002.36247, 12240635
    • Johnson LL. A controlled trial of arthroscopic surgery for osteoarthritis of the knee [letter]. Arthroscopy 2002, 18(7):683-686. 10.1053/jars.2002.36247, 12240635.
    • (2002) Arthroscopy , vol.18 , Issue.7 , pp. 683-686
    • Johnson, L.L.1
  • 19
    • 0036718699 scopus 로고    scopus 로고
    • A controlled trial of arthroscopic surgery for osteoarthritis of the knee [letter]
    • Chambers K, Schulzer M, Sobolev B. A controlled trial of arthroscopic surgery for osteoarthritis of the knee [letter]. Arthroscopy 2002, 18:686-7.
    • (2002) Arthroscopy , vol.18 , pp. 686-687
    • Chambers, K.1    Schulzer, M.2    Sobolev, B.3
  • 20
    • 0001457476 scopus 로고
    • Qualitative data analysis for applied policy research
    • London: Routledge, Bryman A, Burgess RG
    • Ritchie J, Spencer L. Qualitative data analysis for applied policy research. Analysing Qualitative Data 1994, London: Routledge, Bryman A, Burgess RG.
    • (1994) Analysing Qualitative Data
    • Ritchie, J.1    Spencer, L.2
  • 21
    • 0001109910 scopus 로고
    • Grading of patients for surgical procedures
    • Saklad M. Grading of patients for surgical procedures. Anesthesiology 1941, 2:281-4.
    • (1941) Anesthesiology , vol.2 , pp. 281-284
    • Saklad, M.1
  • 22
    • 79952361944 scopus 로고    scopus 로고
    • American Society of Anaesthesiology: ASA Physical Status Classification system
    • [cited 7 January 2011].
    • American Society of Anaesthesiology: ASA Physical Status Classification system. [cited 7 January 2011].., http://www.asahq.org/For-Members/Clinical-Information/ASA-Physical-Status-Classification-System.aspx
  • 23
    • 79952360995 scopus 로고    scopus 로고
    • HESonline Hospital Episode Statistics: Total procedures and interventions. [database on the Internet]
    • [cited 30 September 2008].
    • HESonline Hospital Episode Statistics: Total procedures and interventions. [database on the Internet]. NHS Information Centre, 2005-08 [cited 30 September 2008].., http://www.hesonline.nhs.uk/Ease/servlet/ContentServer?siteID=1937&categoryID=210
    • NHS Information Centre, 2005-08
  • 24
    • 0034737962 scopus 로고    scopus 로고
    • What makes clinical research ethical?
    • 10.1001/jama.283.20.2701, 10819955
    • Emmanuel EJ, Wendler D, Grady C. What makes clinical research ethical?. JAMA 2000, 283:2701-11. 10.1001/jama.283.20.2701, 10819955.
    • (2000) JAMA , vol.283 , pp. 2701-2711
    • Emmanuel, E.J.1    Wendler, D.2    Grady, C.3
  • 25
    • 0037063111 scopus 로고    scopus 로고
    • Is placebo surgery unethical?
    • 10.1056/NEJMsb021025, 12110744
    • Horng S, Miller FG. Is placebo surgery unethical?. New Engl J Med 2002, 347:137-139. 10.1056/NEJMsb021025, 12110744.
    • (2002) New Engl J Med , vol.347 , pp. 137-139
    • Horng, S.1    Miller, F.G.2
  • 26
    • 40949113623 scopus 로고    scopus 로고
    • Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study
    • 10.1136/bmj.39465.451748.AD, 2267990, 18316340
    • Wood L, Egger M, Gluud LL, Schulz KF, Juni P, Altman DG, Gluud C, Martin RM, Wood AJG, Sterne JAC. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ 2008, 336:601-5. 10.1136/bmj.39465.451748.AD, 2267990, 18316340.
    • (2008) BMJ , vol.336 , pp. 601-605
    • Wood, L.1    Egger, M.2    Gluud, L.L.3    Schulz, K.F.4    Juni, P.5    Altman, D.G.6    Gluud, C.7    Martin, R.M.8    Wood, A.J.G.9    Sterne, J.A.C.10
  • 27
    • 23944518089 scopus 로고    scopus 로고
    • The ethics of placebo-controlled trials: a comparison of inert and active placebo controls
    • 10.1007/s00268-005-7621-7, 15827854
    • Edwards SJL, Stevens AJ, Braunholtz DA, Lilford RJ, Swift T. The ethics of placebo-controlled trials: a comparison of inert and active placebo controls. World J Surg 2005, 29(5):610-4. 10.1007/s00268-005-7621-7, 15827854.
    • (2005) World J Surg , vol.29 , Issue.5 , pp. 610-614
    • Edwards, S.J.L.1    Stevens, A.J.2    Braunholtz, D.A.3    Lilford, R.J.4    Swift, T.5
  • 30
    • 0032750122 scopus 로고    scopus 로고
    • Issues in surgical randomized controlled trials
    • 10.1007/s002689900649, 10552108
    • McLeod RS. Issues in surgical randomized controlled trials. World J Surg 1999, 23:1210-4. 10.1007/s002689900649, 10552108.
    • (1999) World J Surg , vol.23 , pp. 1210-1214
    • McLeod, R.S.1
  • 31
    • 70349294326 scopus 로고    scopus 로고
    • Challenges in evaluating surgical innovation
    • 10.1016/S0140-6736(09)61086-2, 2855679, 19782875, for the Balliol Collaboration
    • Ergina PL, Cook JA, Blazeby JM, Boutron I, Calvien PA, Reeves BC, Seiler CM, . for the Balliol Collaboration Challenges in evaluating surgical innovation. Lancet 2009, 374:1097-104. 10.1016/S0140-6736(09)61086-2, 2855679, 19782875, for the Balliol Collaboration.
    • (2009) Lancet , vol.374 , pp. 1097-1104
    • Ergina, P.L.1    Cook, J.A.2    Blazeby, J.M.3    Boutron, I.4    Calvien, P.A.5    Reeves, B.C.6    Seiler, C.M.7
  • 32
    • 0026503444 scopus 로고
    • "Will you help me with my research?" Gaining access to primary care settings and subjects
    • Murphy E, Spiegal N, Kinmonth AL. "Will you help me with my research?" Gaining access to primary care settings and subjects. Brit J Gen Pract 1992, 42(357):162-5.
    • (1992) Brit J Gen Pract , vol.42 , Issue.357 , pp. 162-165
    • Murphy, E.1    Spiegal, N.2    Kinmonth, A.L.3
  • 33
    • 0033868042 scopus 로고    scopus 로고
    • A recruitment strategy for cluster randomised trials in secondary care settings
    • 10.1046/j.1365-2753.2000.00235.x, 10970012, the TEMPEST group
    • Walker A, Campbell MK, Grimshaw JM, . the TEMPEST group A recruitment strategy for cluster randomised trials in secondary care settings. J Eval Clin Pract 2000, 6:185-92. 10.1046/j.1365-2753.2000.00235.x, 10970012, the TEMPEST group.
    • (2000) J Eval Clin Pract , vol.6 , pp. 185-192
    • Walker, A.1    Campbell, M.K.2    Grimshaw, J.M.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.