-
1
-
-
84971580244
-
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
-
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
-
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
-
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
-
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
-
7
-
-
67650742305
-
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
-
8
-
-
84872677390
-
Adverse event reporting in randomised controlled trials of neuropathic pain: Considerations for future practice
-
V.R. Cornelius, O. Sauzet, J.E. Williams, S. Ayis, P. Farquhar-Smith, J.R. Ross, R.A. Branford, and J.L. Peacock Adverse event reporting in randomised controlled trials of neuropathic pain: considerations for future practice PAIN® 154 2013 213 220
-
(2013)
PAIN®
, vol.154
, pp. 213-220
-
-
Cornelius, V.R.1
Sauzet, O.2
Williams, J.E.3
Ayis, S.4
Farquhar-Smith, P.5
Ross, J.R.6
Branford, R.A.7
Peacock, J.L.8
-
9
-
-
78649832568
-
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
-
10
-
-
19944381491
-
Core outcome measures for chronic pain clinical trials: IMMPACT recommendations
-
R.H. Dworkin, D.C. Turk, J.T. Farrar, J.A. Haythornthwaite, M.P. Jensen, N.P. Katz, R.D. Kerns, G. Stucki, R.R. Allen, N. Bellamy, D.B. Carr, J. Chandler, P. Cowan, R. Dionne, B.S. Galer, S. Hertz, A.R. Jadad, L.D. Kramer, D.C. Manning, S. Martin, C.G. McCormick, M.P. McDermott, P. McGrath, S. Quessy, B.A. Rappaport, W. Robbins, J.P. Robinson, M. Rothman, M.A. Royal, L. Simon, J.W. Stauffer, W. Stein, J. Tollett, J. Wernicke, and J. Witter Core outcome measures for chronic pain clinical trials: IMMPACT recommendations PAIN® 113 2005 9 19
-
(2005)
PAIN®
, vol.113
, pp. 9-19
-
-
Dworkin, R.H.1
Turk, D.C.2
Farrar, J.T.3
Haythornthwaite, J.A.4
Jensen, M.P.5
Katz, N.P.6
Kerns, R.D.7
Stucki, G.8
Allen, R.R.9
Bellamy, N.10
Carr, D.B.11
Chandler, J.12
Cowan, P.13
Dionne, R.14
Galer, B.S.15
Hertz, S.16
Jadad, A.R.17
Kramer, L.D.18
Manning, D.C.19
Martin, S.20
McCormick, C.G.21
McDermott, M.P.22
McGrath, P.23
Quessy, S.24
Rappaport, B.A.25
Robbins, W.26
Robinson, J.P.27
Rothman, M.28
Royal, M.A.29
Simon, L.30
Stauffer, J.W.31
Stein, W.32
Tollett, J.33
Wernicke, J.34
Witter, J.35
more..
-
11
-
-
0032694314
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
20
-
-
8744229000
-
Better reporting of harms in randomized trials: An extension of the CONSORT statement
-
J.P.A. Ioannidis, S.J. Evans, P.C. Gotzsche, R.T. O'Neill, D.G. Altman, K. Schulz, and D. Moher 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.A.1
Evans, S.J.2
Gotzsche, P.C.3
O'Neill, R.T.4
Altman, D.G.5
Schulz, K.6
Moher, D.7
-
21
-
-
0035941525
-
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
-
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
-
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
-
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
-
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
-
26
-
-
84866345932
-
A randomized study of how physicians interpret research funding disclosures
-
A.S. Kesselheim, C.T. Robertson, J.A. Myers, S.L. Rose, V. Gillet, K.M. Ross, R.J. Glynn, S. Joffe, and J. Avorn A randomized study of how physicians interpret research funding disclosures N Engl J Med 367 2012 1119 1127
-
(2012)
N Engl J Med
, vol.367
, pp. 1119-1127
-
-
Kesselheim, A.S.1
Robertson, C.T.2
Myers, J.A.3
Rose, S.L.4
Gillet, V.5
Ross, K.M.6
Glynn, R.J.7
Joffe, S.8
Avorn, J.9
-
27
-
-
84872688468
-
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
-
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
-
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
-
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
-
31
-
-
79953045419
-
Assessing general side effects in clinical trials: Reference data from the general population
-
W. Rief, A.J. Barsky, J.A. Glombiewski, Y. Nestoriuc, H. Glaesmer, and E. Braehler Assessing general side effects in clinical trials: reference data from the general population Pharmacoepidemiol Drug Saf 20 2011 405 415
-
(2011)
Pharmacoepidemiol Drug Saf
, vol.20
, pp. 405-415
-
-
Rief, W.1
Barsky, A.J.2
Glombiewski, J.A.3
Nestoriuc, Y.4
Glaesmer, H.5
Braehler, E.6
-
33
-
-
70349972975
-
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
-
34
-
-
0030027092
-
Evidence based medicine: What it is and what it isn't
-
D.L. Sackett, W.M. Rosenberg, J.A. Gray, R.B. Haynes, and W.S. Richardson Evidence based medicine: what it is and what it isn't BMJ 312 1996 71 72
-
(1996)
BMJ
, vol.312
, pp. 71-72
-
-
Sackett, D.L.1
Rosenberg, W.M.2
Gray, J.A.3
Haynes, R.B.4
Richardson, W.S.5
-
35
-
-
78751569771
-
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
-
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
-
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
-
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
-
39
-
-
84868524764
-
Adherence to CONSORT harms reporting recommendations in publications of recent analgesic clinical trials: An ACTTION systematic review
-
S.M. Smith, R.D. Chang, A. Pereira, N. Shah, I. Gilron, N.P. Katz, A.H. Lin, M.P. McDermott, B.A. Rappaport, M.C. Rowbotham, C. Sampaio, D.C. Turk, and R.H. Dworkin Adherence to CONSORT harms reporting recommendations in publications of recent analgesic clinical trials: an ACTTION systematic review PAIN® 153 2012 2415 2421
-
(2012)
PAIN®
, vol.153
, pp. 2415-2421
-
-
Smith, S.M.1
Chang, R.D.2
Pereira, A.3
Shah, N.4
Gilron, I.5
Katz, N.P.6
Lin, A.H.7
McDermott, M.P.8
Rappaport, B.A.9
Rowbotham, M.C.10
Sampaio, C.11
Turk, D.C.12
Dworkin, R.H.13
-
40
-
-
0035956651
-
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
-
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
-
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
-
43
-
-
10744226487
-
Core outcome domains for chronic pain clinical trials: IMMPACT recommendations
-
D.C. Turk, R.H. Dworkin, R.R. Allen, N. Bellamy, N. Brandenburg, D.B. Carr, C. Cleeland, R. Dionne, J.T. Farrar, B.S. Galer, D.J. Hewitt, A. Jadad, N.P. Katz, L.D. Kramer, D.C. Manning, C.G. McCormic, M. McDermott, P. McGrath, S. Quessy, B.A. Rappaport, J.P. Robinson, M.A. Royal, L. Simon, J.W. Stauffer, W. Stein, J. Tollett, and J. Witter Core outcome domains for chronic pain clinical trials: IMMPACT recommendations PAIN® 106 2003 337 345
-
(2003)
PAIN®
, vol.106
, pp. 337-345
-
-
Turk, D.C.1
Dworkin, R.H.2
Allen, R.R.3
Bellamy, N.4
Brandenburg, N.5
Carr, D.B.6
Cleeland, C.7
Dionne, R.8
Farrar, J.T.9
Galer, B.S.10
Hewitt, D.J.11
Jadad, A.12
Katz, N.P.13
Kramer, L.D.14
Manning, D.C.15
McCormic, C.G.16
McDermott, M.17
McGrath, P.18
Quessy, S.19
Rappaport, B.A.20
Robinson, J.P.21
Royal, M.A.22
Simon, L.23
Stauffer, J.W.24
Stein, W.25
Tollett, J.26
Witter, J.27
more..
-
44
-
-
80052037786
-
An evaluation of the completeness of safety reporting in reports of complementary and alternative medicine trials
-
L.A. Turner, K. Singh, C. Garritty, A. Tsertsvadze, E. Manheimer, L.S. Wieland, J. Galipeau, and D. Moher An evaluation of the completeness of safety reporting in reports of complementary and alternative medicine trials BMC Complement Altern Med 11 2011 67
-
(2011)
BMC Complement Altern Med
, vol.11
, pp. 67
-
-
Turner, L.A.1
Singh, K.2
Garritty, C.3
Tsertsvadze, A.4
Manheimer, E.5
Wieland, L.S.6
Galipeau, J.7
Moher, D.8
-
45
-
-
79959283469
-
-
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
-
-
-
46
-
-
12444326149
-
Patient-reported medication symptoms in primary care
-
S.N. Weingart, T.K. Gandhi, A.C. Seger, D.L. Seger, J. Borus, E. Burdick, L.L. Leape, and D.W. Bates Patient-reported medication symptoms in primary care Arch Intern Med 165 2005 234 240
-
(2005)
Arch Intern Med
, vol.165
, pp. 234-240
-
-
Weingart, S.N.1
Gandhi, T.K.2
Seger, A.C.3
Seger, D.L.4
Borus, J.5
Burdick, E.6
Leape, L.L.7
Bates, D.W.8
|