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Volumn 154, Issue 7, 2013, Pages 997-1008

Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations

(15)  Smith, Shannon M a   Wang, Anthony T b   Katz, Nathaniel P c,d   McDermott, Michael P a   Burke, Laurie B e   Coplan, Paul f,g   Gilron, Ian h   Hertz, Sharon H e   Lin, Allison H e   Rappaport, Bob A e   Rowbotham, Michael C i   Sampaio, Cristina j   Sweeney, Michael k   Turk, Dennis C l   Dworkin, Robert H a  


Author keywords

Adverse events; Analgesic medications; Clinical trials; CONSORT; Systematic review

Indexed keywords

ANALGESIC AGENT;

EID: 84878785567     PISSN: 03043959     EISSN: 18726623     Source Type: Journal    
DOI: 10.1016/j.pain.2013.03.003     Document Type: Article
Times cited : (50)

References (46)
  • 1
    • 84971580244 scopus 로고
    • Absence of evidence is not evidence of absence
    • D.G. Altman, and J.M. Bland Absence of evidence is not evidence of absence BMJ 311 1995 48
    • (1995) BMJ , vol.311 , pp. 48
    • Altman, D.G.1    Bland, J.M.2
  • 2
    • 70350619625 scopus 로고    scopus 로고
    • A systematic review of adverse events in placebo groups of anti-migraine clinical trials
    • M. Amanzio, L.L. Corazzini, L. Vase, and F. Benedetti A systematic review of adverse events in placebo groups of anti-migraine clinical trials PAIN® 146 2009 261 269
    • (2009) PAIN® , vol.146 , pp. 261-269
    • Amanzio, M.1    Corazzini, L.L.2    Vase, L.3    Benedetti, F.4
  • 3
    • 0033548854 scopus 로고    scopus 로고
    • Physical symptoms distress index: A sensitive tool to evaluate the impact of pharmacological agents on quality of life
    • R.B. Anderson, N.K. Hollenberg, and G.H. Williams Physical symptoms distress index: a sensitive tool to evaluate the impact of pharmacological agents on quality of life Arch Intern Med 159 1999 693 700
    • (1999) Arch Intern Med , vol.159 , pp. 693-700
    • Anderson, R.B.1    Hollenberg, N.K.2    Williams, G.H.3
  • 4
    • 77949407113 scopus 로고    scopus 로고
    • The missing voice of patients in drug-safety reporting
    • E. Basch The missing voice of patients in drug-safety reporting N Engl J Med 362 2010 865 869
    • (2010) N Engl J Med , vol.362 , pp. 865-869
    • Basch, E.1
  • 5
    • 33644906137 scopus 로고    scopus 로고
    • Brief communication: Better ways to question patients about adverse events
    • S. Bent, A. Padula, and A.L. Avins Brief communication: better ways to question patients about adverse events Ann Intern Med 144 2006 257 261
    • (2006) Ann Intern Med , vol.144 , pp. 257-261
    • Bent, S.1    Padula, A.2    Avins, A.L.3
  • 6
  • 7
    • 67650742305 scopus 로고    scopus 로고
    • Reporting of adverse events in randomized controlled trials of highly antiretroviral therapy: Systematic review
    • M.Y. Chowers, B.S. Gottesman, L. Leibovici, U. Pielmeier, S. Andreassen, and M. Paul Reporting of adverse events in randomized controlled trials of highly antiretroviral therapy: systematic review J Antimicrob Chemother 64 2009 239 250
    • (2009) J Antimicrob Chemother , vol.64 , pp. 239-250
    • Chowers, M.Y.1    Gottesman, B.S.2    Leibovici, L.3    Pielmeier, U.4    Andreassen, S.5    Paul, M.6
  • 9
    • 78649832568 scopus 로고    scopus 로고
    • Low quality of reporting adverse drug reactions in paediatric randomised controlled trials
    • T.W. de Vries, and E.N. van Roon Low quality of reporting adverse drug reactions in paediatric randomised controlled trials Arch Dis Child 95 2010 1023 1026
    • (2010) Arch Dis Child , vol.95 , pp. 1023-1026
    • De Vries, T.W.1    Van Roon, E.N.2
  • 11
    • 0032694314 scopus 로고    scopus 로고
    • Reporting of adverse effects in clinical trials should be improved: Lessons from acute postoperative pain
    • J.E. Edwards, H.J. McQuay, and A. Moore Reporting of adverse effects in clinical trials should be improved: lessons from acute postoperative pain J Pain Symptom Manage 18 1999 427 437
    • (1999) J Pain Symptom Manage , vol.18 , pp. 427-437
    • Edwards, J.E.1    McQuay, H.J.2    Moore, A.3
  • 12
    • 21544455512 scopus 로고    scopus 로고
    • Reporting of harm in randomized, controlled trials of nonpharmacologic treatment for rheumatic disease
    • M. Ethgen, I. Boutron, G. Baron, B. Giraudeau, J. Sibilia, and P. Ravaud Reporting of harm in randomized, controlled trials of nonpharmacologic treatment for rheumatic disease Ann Intern Med 143 2005 20 25
    • (2005) Ann Intern Med , vol.143 , pp. 20-25
    • Ethgen, M.1    Boutron, I.2    Baron, G.3    Giraudeau, B.4    Sibilia, J.5    Ravaud, P.6
  • 13
    • 52649135630 scopus 로고    scopus 로고
    • Identifying and addressing safety signals in clinical trials
    • T.R. Fleming Identifying and addressing safety signals in clinical trials N Engl J Med 359 2008 1400 1402
    • (2008) N Engl J Med , vol.359 , pp. 1400-1402
    • Fleming, T.R.1
  • 14
    • 78650517607 scopus 로고    scopus 로고
    • The quality of safety reporting in trials is still suboptimal: Survey of major general medical journals
    • A. Haidich, C. Birtsou, T. Dardavessis, I. Tirodimos, and M. Arvanitidou The quality of safety reporting in trials is still suboptimal: survey of major general medical journals J Clin Epidemiol 64 2011 124 135
    • (2011) J Clin Epidemiol , vol.64 , pp. 124-135
    • Haidich, A.1    Birtsou, C.2    Dardavessis, T.3    Tirodimos, I.4    Arvanitidou, M.5
  • 15
    • 80054802888 scopus 로고    scopus 로고
    • Secondary use of randomized controlled trials to evaluate drug safety: A review of methodological considerations
    • T.A. Hammad, S.P. Pinheiro, and G.A. Neyarapally Secondary use of randomized controlled trials to evaluate drug safety: a review of methodological considerations Clin Trials 8 2011 559 570
    • (2011) Clin Trials , vol.8 , pp. 559-570
    • Hammad, T.A.1    Pinheiro, S.P.2    Neyarapally, G.A.3
  • 16
    • 84861100206 scopus 로고    scopus 로고
    • Adverse events attributable to nocebo in randomized controlled drug trials in fibromyalgia syndrome and painful diabetic peripheral neuropathy: Systematic review
    • W. Hauser, C. Bartram, E. Bartram-Wunn, and T. Tolle Adverse events attributable to nocebo in randomized controlled drug trials in fibromyalgia syndrome and painful diabetic peripheral neuropathy: systematic review Clin J Pain 28 2012 437 451
    • (2012) Clin J Pain , vol.28 , pp. 437-451
    • Hauser, W.1    Bartram, C.2    Bartram-Wunn, E.3    Tolle, T.4
  • 18
    • 70350517166 scopus 로고    scopus 로고
    • Adverse events in randomized trials: Neglected, restricted, distorted, and silenced
    • J.P.A. Ioannidis Adverse events in randomized trials: neglected, restricted, distorted, and silenced Arch Intern Med 169 2009 1737 1739
    • (2009) Arch Intern Med , vol.169 , pp. 1737-1739
    • Ioannidis, J.P.A.1
  • 19
    • 0032576406 scopus 로고    scopus 로고
    • Reporting of safety data from randomized trials
    • J.P.A. Ioannidis, and D.G. Contopoulos-Ioannidis Reporting of safety data from randomized trials Lancet 352 1998 1752 1753
    • (1998) Lancet , vol.352 , pp. 1752-1753
    • Ioannidis, J.P.A.1    Contopoulos-Ioannidis, D.G.2
  • 21
    • 0035941525 scopus 로고    scopus 로고
    • Completeness of safety reporting in randomized trials: An evaluation of 7 medical areas
    • J.P.A. Ioannidis, and J. Lau Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas JAMA 285 2001 437 443
    • (2001) JAMA , vol.285 , pp. 437-443
    • Ioannidis, J.P.A.1    Lau, J.2
  • 22
    • 0036195685 scopus 로고    scopus 로고
    • Improving safety reporting from randomised trials
    • J.P.A. Ioannidis, and J. Lau Improving safety reporting from randomised trials Drug Saf 25 2002 77 84
    • (2002) Drug Saf , vol.25 , pp. 77-84
    • Ioannidis, J.P.A.1    Lau, J.2
  • 23
    • 33644896238 scopus 로고    scopus 로고
    • Adverse effects: The more you search, the more you find
    • J.P.A. Ioannidis, C.D. Mulrow, and S.N. Goodman Adverse effects: the more you search, the more you find Ann Intern Med 144 2006 298 300
    • (2006) Ann Intern Med , vol.144 , pp. 298-300
    • Ioannidis, J.P.A.1    Mulrow, C.D.2    Goodman, S.N.3
  • 24
    • 33644929695 scopus 로고    scopus 로고
    • Reporting of drug tolerance in randomized clinical trials: When data conflict with authors' conclusions
    • A.P. Jonville-Bera, B. Giraudeau, and E. Autret-Leca Reporting of drug tolerance in randomized clinical trials: when data conflict with authors' conclusions Ann Intern Med 144 2006 306 307
    • (2006) Ann Intern Med , vol.144 , pp. 306-307
    • Jonville-Bera, A.P.1    Giraudeau, B.2    Autret-Leca, E.3
  • 25
    • 84864304171 scopus 로고    scopus 로고
    • The measurement of symptoms and side effects in clinical trials of chronic pain
    • N.P. Katz The measurement of symptoms and side effects in clinical trials of chronic pain Contemp Clin Trials 33 2012 903 911
    • (2012) Contemp Clin Trials , vol.33 , pp. 903-911
    • Katz, N.P.1
  • 27
    • 84872688468 scopus 로고    scopus 로고
    • Lack of clarity in reports of adverse events: Is there any harm?
    • Y.K. Loke Lack of clarity in reports of adverse events: is there any harm? PAIN® 154 2013 183 184
    • (2013) PAIN® , vol.154 , pp. 183-184
    • Loke, Y.K.1
  • 28
    • 5644240874 scopus 로고    scopus 로고
    • Advances in risk-benefit evaluation using probabilistic simulation methods: An application of the prophylaxis of deep vein thrombosis
    • L.D. Lynd, and B.J. O'Brien Advances in risk-benefit evaluation using probabilistic simulation methods: an application of the prophylaxis of deep vein thrombosis J Clin Epidemiol 57 2004 795 803
    • (2004) J Clin Epidemiol , vol.57 , pp. 795-803
    • Lynd, L.D.1    O'Brien, B.J.2
  • 29
    • 70350489859 scopus 로고    scopus 로고
    • Reporting of safety results in published reports of randomized controlled trials
    • I. Pitrou, I. Boutron, N. Ahmad, and P. Ravaud Reporting of safety results in published reports of randomized controlled trials Arch Intern Med 169 2009 1756 1761
    • (2009) Arch Intern Med , vol.169 , pp. 1756-1761
    • Pitrou, I.1    Boutron, I.2    Ahmad, N.3    Ravaud, P.4
  • 30
    • 31344471005 scopus 로고    scopus 로고
    • Medication-attributed adverse effects in placebo groups
    • W. Rief, J. Avorn, and A.J. Barsky Medication-attributed adverse effects in placebo groups Arch Intern Med 166 2006 155 160
    • (2006) Arch Intern Med , vol.166 , pp. 155-160
    • Rief, W.1    Avorn, J.2    Barsky, A.J.3
  • 33
    • 70349972975 scopus 로고    scopus 로고
    • Differences in adverse effect reporting in placebo groups in SSRI and tricyclic antidepressant trials: A systematic review and meta-analysis
    • W. Rief, Y. Nestoriuc, A. von Lilienfeld-Toal, I. Dogan, F. Schreiber, S.G. Hofmann, A.J. Barsky, and J. Avorn Differences in adverse effect reporting in placebo groups in SSRI and tricyclic antidepressant trials: a systematic review and meta-analysis Drug Saf 32 2009 1041 1056
    • (2009) Drug Saf , vol.32 , pp. 1041-1056
    • Rief, W.1    Nestoriuc, Y.2    Von Lilienfeld-Toal, A.3    Dogan, I.4    Schreiber, F.5    Hofmann, S.G.6    Barsky, A.J.7    Avorn, J.8
  • 35
    • 78751569771 scopus 로고    scopus 로고
    • Use of the internet by print medical journals in 2003-2009: A longitudinal observational study
    • D.L. Schriger, A.C. Chehrazi, R.M. Merchant, and D.G. Altman Use of the internet by print medical journals in 2003-2009: a longitudinal observational study Ann Emerg Med 57 2011 e3
    • (2011) Ann Emerg Med , vol.57 , pp. 3
    • Schriger, D.L.1    Chehrazi, A.C.2    Merchant, R.M.3    Altman, D.G.4
  • 36
    • 84864113283 scopus 로고    scopus 로고
    • Challenges in coding adverse events in clinical trials: A systematic review
    • J.B. Schroll, E. Maund, and P.C. Gotzsche Challenges in coding adverse events in clinical trials: a systematic review PLoS One 7 2012 e41174
    • (2012) PLoS One , vol.7 , pp. 41174
    • Schroll, J.B.1    Maund, E.2    Gotzsche, P.C.3
  • 37
    • 8844285858 scopus 로고    scopus 로고
    • Assessment of adverse events associated with triptans - Methods of assessment influence the results
    • F.D. Sheftell, M. Feleppa, S.J. Tepper, A.M. Rapoport, L. Ciannella, and M.E. Bigal Assessment of adverse events associated with triptans - methods of assessment influence the results Headache 44 2004 978 982
    • (2004) Headache , vol.44 , pp. 978-982
    • Sheftell, F.D.1    Feleppa, M.2    Tepper, S.J.3    Rapoport, A.M.4    Ciannella, L.5    Bigal, M.E.6
  • 38
    • 81055157670 scopus 로고    scopus 로고
    • Reporting of adverse events in randomised controlled trials of antiepileptic drugs using the CONSORT criteria for reporting harms
    • A.A. Shukralla, C. Tudur-Smith, G.A. Powell, P.R. Williamson, and A.G. Marson Reporting of adverse events in randomised controlled trials of antiepileptic drugs using the CONSORT criteria for reporting harms Epilepsy Res 97 2011 20 29
    • (2011) Epilepsy Res , vol.97 , pp. 20-29
    • Shukralla, A.A.1    Tudur-Smith, C.2    Powell, G.A.3    Williamson, P.R.4    Marson, A.G.5
  • 40
    • 0035956651 scopus 로고    scopus 로고
    • Sifting the evidence - What's wrong with significance tests?
    • J.A. Sterne, and G.D. Smith Sifting the evidence - what's wrong with significance tests? BMJ 27 2001 226 231
    • (2001) BMJ , vol.27 , pp. 226-231
    • Sterne, J.A.1    Smith, G.D.2
  • 41
    • 0027468396 scopus 로고
    • Quality of life and antihypertensive therapy in men. A comparison of captopril with enalapril
    • M.A. Testa, R.B. Anderson, J.F. Nackley, and N.K. Hollenberg Quality of life and antihypertensive therapy in men. A comparison of captopril with enalapril N Engl J Med 328 1993 907 913
    • (1993) N Engl J Med , vol.328 , pp. 907-913
    • Testa, M.A.1    Anderson, R.B.2    Nackley, J.F.3    Hollenberg, N.K.4
  • 42
    • 67349105052 scopus 로고    scopus 로고
    • Inadequate statistical power to detect clinically significant differences in adverse event rates in randomized controlled trials
    • R. Tsang, L. Colley, and L.D. Lynd Inadequate statistical power to detect clinically significant differences in adverse event rates in randomized controlled trials J Clin Epidemiol 62 2009 609 616
    • (2009) J Clin Epidemiol , vol.62 , pp. 609-616
    • Tsang, R.1    Colley, L.2    Lynd, L.D.3
  • 45
    • 79959283469 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research [accessed 23.07.12]
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry and investigators safety reporting requirements for INDs and BA/BE studies, draft guidance. < http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227351.pdf >; 2010 [accessed 23.07.12].
    • (2010) Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA/BE Studies, Draft Guidance


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