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Volumn 18, Issue 1, 2017, Pages

Why clinical trial outcomes fail to translate into benefits for patients

Author keywords

Clinical outcomes; Composite outcomes; Core outcome sets; Publication bias; Reporting bias; Surrogate outcomes

Indexed keywords

ANTIDEPRESSANT AGENT; GLYCOSYLATED HEMOGLOBIN; PROSTATE SPECIFIC ANTIGEN;

EID: 85014930406     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-017-1870-2     Document Type: Note
Times cited : (266)

References (70)
  • 1
    • 85014565952 scopus 로고    scopus 로고
    • Quality of life, overall survival, and costs of cancer drugs approved based on surrogate endpoints
    • Rupp T, Zuckerman D. Quality of life, overall survival, and costs of cancer drugs approved based on surrogate endpoints. JAMA Intern Med. 2017;177:276-7. doi: 10.1001/jamainternmed.2016.7761.
    • (2017) JAMA Intern Med , vol.177 , pp. 276-277
    • Rupp, T.1    Zuckerman, D.2
  • 2
    • 82355180021 scopus 로고    scopus 로고
    • WHO handbook for guideline developers
    • Geneva: WHO. Accessed 11 Mar 2017
    • World Health Organisation (WHO). WHO handbook for guideline developers. Geneva: WHO; 2012. http://apps.who.int/iris/bitstream/10665/75146/1/9789241548441_eng.pdf?ua=1. Accessed 11 Mar 2017.
    • (2012)
  • 3
    • 84892708979 scopus 로고    scopus 로고
    • The trials methodological research agenda: results from a priority setting exercise
    • Tudur Smith C, Hickey H, Clarke M, Blazeby J, Williamson P. The trials methodological research agenda: results from a priority setting exercise. Trials. 2014;15:32. doi: 10.1186/1745-6215-15-32.
    • (2014) Trials , vol.15 , pp. 32
    • Tudur Smith, C.1    Hickey, H.2    Clarke, M.3    Blazeby, J.4    Williamson, P.5
  • 4
    • 65249164099 scopus 로고    scopus 로고
    • Surrogate outcome markers in research and clinical practice
    • Twaddell S. Surrogate outcome markers in research and clinical practice. Aust Prescr. 2009;32:47-50. doi: 10.18773/austprescr.2009.023.
    • (2009) Aust Prescr , vol.32 , pp. 47-50
    • Twaddell, S.1
  • 5
    • 84859009496 scopus 로고    scopus 로고
    • The idolatry of the surrogate
    • Yudkin JS, Lipska KJ, Montori VM. The idolatry of the surrogate. BMJ. 2011;343:d7995. doi: 10.1136/bmj.d7995.
    • (2011) BMJ , vol.343
    • Yudkin, J.S.1    Lipska, K.J.2    Montori, V.M.3
  • 6
    • 77956124790 scopus 로고    scopus 로고
    • Inconsistent reporting of surrogate outcomes in randomised clinical trials: cohort study
    • la Cour JL, Brok J, Gøtzsche PC. Inconsistent reporting of surrogate outcomes in randomised clinical trials: cohort study. BMJ. 2010;341:c3653. doi: 10.1136/bmj.c3653.
    • (2010) BMJ , vol.341
    • Cour, J.L.1    Brok, J.2    Gøtzsche, P.C.3
  • 7
    • 19444362507 scopus 로고    scopus 로고
    • Systems for grading the quality of evidence and the strength of recommendations II: pilot study of a new system
    • Atkins D, Briss PA, Eccles M, Flottorp S, Guyatt GH, Harbour RT, et al. Systems for grading the quality of evidence and the strength of recommendations II: pilot study of a new system. BMC Health Serv Res. 2005;5:25. doi: 10.1186/1472-6963-5-25.
    • (2005) BMC Health Serv Res , vol.5 , pp. 25
    • Atkins, D.1    Briss, P.A.2    Eccles, M.3    Flottorp, S.4    Guyatt, G.H.5    Harbour, R.T.6
  • 8
    • 0034466713 scopus 로고    scopus 로고
    • Debate: the slippery slope of surrogate outcomes
    • D'Agostino Jr RB. Debate: the slippery slope of surrogate outcomes. Curr Control Trials Cardiovasc Med. 2000;1:76-8. doi: 10.1186/cvm-1-2-076.
    • (2000) Curr Control Trials Cardiovasc Med , vol.1 , pp. 76-78
    • D'Agostino, R.B.1
  • 9
    • 33748748206 scopus 로고    scopus 로고
    • Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial
    • DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) Trial Investigators. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial. Lancet. 2006;368:1096-105. doi: 10.1016/S0140-6736(06)69420-8. A published erratum appears in Lancet. 2006;368:1770.
    • (2006) Lancet , vol.368 , pp. 1096-1105
  • 10
    • 77956579687 scopus 로고    scopus 로고
    • Rosiglitazone: what went wrong?
    • Cohen D. Rosiglitazone: what went wrong? BMJ. 2010;341:c4848. doi: 10.1136/bmj.c4848.
    • (2010) BMJ , vol.341
    • Cohen, D.1
  • 11
    • 34247503838 scopus 로고    scopus 로고
    • Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials
    • Ferreira-González I, Busse JW, Heels-Ansdell D, Montori VM, Akl EA, Bryant DM, et al. Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials. BMJ. 2007;334:786. doi: 10.1136/bmj.39136.682083.AE.
    • (2007) BMJ , vol.334 , pp. 786
    • Ferreira-González, I.1    Busse, J.W.2    Heels-Ansdell, D.3    Montori, V.M.4    Akl, E.A.5    Bryant, D.M.6
  • 12
    • 77956113614 scopus 로고    scopus 로고
    • Interpreting composite outcomes in trials
    • Freemantle N, Calvert MJ. Interpreting composite outcomes in trials. BMJ. 2010;341:c3529. doi: 10.1136/bmj.c3529.
    • (2010) BMJ , vol.341
    • Freemantle, N.1    Calvert, M.J.2
  • 13
    • 77956112139 scopus 로고    scopus 로고
    • Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review
    • Cordoba G, Schwartz L, Woloshin S, Bae H, Gøtzsche PC. Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review. BMJ. 2010;341:c3920. doi: 10.1136/bmj.c3920.
    • (2010) BMJ , vol.341
    • Cordoba, G.1    Schwartz, L.2    Woloshin, S.3    Bae, H.4    Gøtzsche, P.C.5
  • 14
    • 55749083719 scopus 로고    scopus 로고
    • Composite outcomes in cardiovascular research: a survey of randomized trials
    • Lim E, Brown A, Helmy A, Mussa S, Altman DG. Composite outcomes in cardiovascular research: a survey of randomized trials. Ann Intern Med. 2008;149:612-7.
    • (2008) Ann Intern Med. , vol.149 , pp. 612-617
    • Lim, E.1    Brown, A.2    Helmy, A.3    Mussa, S.4    Altman, D.G.5
  • 15
    • 84971441818 scopus 로고    scopus 로고
    • A systematic review of randomised controlled trials in rheumatoid arthritis: the reporting and handling of missing data in composite outcomes
    • Ibrahim F, Tom BDM, Scott DL, Prevost AT. A systematic review of randomised controlled trials in rheumatoid arthritis: the reporting and handling of missing data in composite outcomes. Trials. 2016;17:272. doi: 10.1186/s13063-016-1402-5.
    • (2016) Trials , vol.17 , pp. 272
    • Ibrahim, F.1    Tom, B.D.M.2    Scott, D.L.3    Prevost, A.T.4
  • 16
    • 84922481776 scopus 로고    scopus 로고
    • Subjective and objective outcomes in randomized clinical trials: definitions differed in methods publications and were often absent from trial reports
    • Moustgaard H, Bello S, Miller FG, Hróbjartsson A. Subjective and objective outcomes in randomized clinical trials: definitions differed in methods publications and were often absent from trial reports. J Clin Epidemiol. 2014;67:1327-34. doi: 10.1016/j.jclinepi.2014.06.020.
    • (2014) J Clin Epidemiol , vol.67 , pp. 1327-1334
    • Moustgaard, H.1    Bello, S.2    Miller, F.G.3    Hróbjartsson, A.4
  • 17
    • 61449091559 scopus 로고    scopus 로고
    • Systematic review of measures of clinical significance employed in randomized controlled trials of drugs for dementia
    • Molnar FJ, Man-Son-Hing M, Fergusson D. Systematic review of measures of clinical significance employed in randomized controlled trials of drugs for dementia. J Am Geriatr Soc. 2009;57:536-46. doi: 10.1111/j.1532-5415.2008.02122.x.
    • (2009) J Am Geriatr Soc , vol.57 , pp. 536-546
    • Molnar, F.J.1    Man-Son-Hing, M.2    Fergusson, D.3
  • 18
    • 40949113623 scopus 로고    scopus 로고
    • Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study
    • Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ. 2008;336:601-5. doi: 10.1136/bmj.39465.451748.AD.
    • (2008) BMJ , vol.336 , pp. 601-605
    • Wood, L.1    Egger, M.2    Gluud, L.L.3    Schulz, K.F.4    Jüni, P.5    Altman, D.G.6
  • 19
    • 84858387206 scopus 로고    scopus 로고
    • Observer bias in randomised clinical trials with binary outcomes: systematic review of trials with both blinded and non-blinded outcome assessors
    • Hróbjartsson A, Thomsen ASS, Emanuelsson F, Tendal B, Hilden J, Boutron I, et al. Observer bias in randomised clinical trials with binary outcomes: systematic review of trials with both blinded and non-blinded outcome assessors. BMJ. 2012;344:e1119. doi: 10.1136/bmj.e1119.
    • (2012) BMJ , vol.344
    • Hróbjartsson, A.1    Thomsen, A.S.S.2    Emanuelsson, F.3    Tendal, B.4    Hilden, J.5    Boutron, I.6
  • 20
    • 84978859510 scopus 로고    scopus 로고
    • Empirical evidence of study design biases in randomized trials: systematic review of meta-epidemiological studies
    • Page MJ, Higgins JPT, Clayton G, Sterne JA, Hróbjartsson A, Savović J. Empirical evidence of study design biases in randomized trials: systematic review of meta-epidemiological studies. PLoS One. 2016;11:e0159267. doi: 10.1371/journal.pone.0159267.
    • (2016) PLoS One , vol.11
    • Page, M.J.1    Higgins, J.P.T.2    Clayton, G.3    Sterne, J.A.4    Hróbjartsson, A.5    Savović, J.6
  • 21
    • 84936818702 scopus 로고    scopus 로고
    • Deviation from intention to treat analysis in randomised trials and treatment effect estimates: meta-epidemiological study
    • Abraha I, Cherubini A, Cozzolino F, De Florio R, Luchetta ML, Rimland JM, et al. Deviation from intention to treat analysis in randomised trials and treatment effect estimates: meta-epidemiological study. BMJ. 2015;350:h2445. doi: 10.1136/bmj.h2445.
    • (2015) BMJ , vol.350
    • Abraha, I.1    Cherubini, A.2    Cozzolino, F.3    Florio, R.4    Luchetta, M.L.5    Rimland, J.M.6
  • 22
    • 0034069988 scopus 로고    scopus 로고
    • Unpublished rating scales: a major source of bias in randomised controlled trials of treatments for schizophrenia
    • Marshall M, Lockwood A, Bradley C, Adams C, Joy C, Fenton M. Unpublished rating scales: a major source of bias in randomised controlled trials of treatments for schizophrenia. Br J Psychiatry. 2000;176:249-52. doi: 10.1192/bjp.176.3.249.
    • (2000) Br J Psychiatry , vol.176 , pp. 249-252
    • Marshall, M.1    Lockwood, A.2    Bradley, C.3    Adams, C.4    Joy, C.5    Fenton, M.6
  • 23
    • 0024550344 scopus 로고
    • Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis
    • Gøtzsche PC. Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis. Control Clin Trials. 1989;10:31-56. https://www.ncbi.nlm.nih.gov/pubmed/2702836. A published erratum appears in Control Clin Trials. 1989;10:356.
    • (1989) Control Clin Trials , vol.10 , pp. 31-56
    • Gøtzsche, P.C.1
  • 24
    • 36148981831 scopus 로고    scopus 로고
    • Rating scales as outcome measures for clinical trials in neurology: problems, solutions, and recommendations
    • Hobart JC, Cano SJ, Zajicek JP, Thompson AJ. Rating scales as outcome measures for clinical trials in neurology: problems, solutions, and recommendations. Lancet Neurol. 2007;6:1094-105. doi: 10.1016/S1474-4422(07)70290-9. A published erratum appears in Lancet Neurol. 2008;7:25.
    • (2007) Lancet Neurol , vol.6 , pp. 1094-1105
    • Hobart, J.C.1    Cano, S.J.2    Zajicek, J.P.3    Thompson, A.J.4
  • 25
    • 78349261942 scopus 로고    scopus 로고
    • Outcome selection and role of patient reported outcomes in contemporary cardiovascular trials: systematic review
    • Rahimi K, Malhotra A, Banning AP, Jenkinson C. Outcome selection and role of patient reported outcomes in contemporary cardiovascular trials: systematic review. BMJ. 2010;341:c5707. doi: 10.1136/bmj.c5707.
    • (2010) BMJ , vol.341
    • Rahimi, K.1    Malhotra, A.2    Banning, A.P.3    Jenkinson, C.4
  • 26
    • 34247530125 scopus 로고    scopus 로고
    • Factors that can affect the external validity of randomised controlled trials
    • Rothwell PM. Factors that can affect the external validity of randomised controlled trials. PLoS Clin Trials. 2006;1:e9. doi: 10.1371/journal.pctr.0010009.
    • (2006) PLoS Clin Trials , vol.1
    • Rothwell, P.M.1
  • 27
    • 34548324381 scopus 로고    scopus 로고
    • How can we assess outcomes of clinical trials: the MCID approach
    • Make B. How can we assess outcomes of clinical trials: the MCID approach. COPD. 2007;4:191-4.
    • (2007) COPD , vol.4 , pp. 191-194
    • Make, B.1
  • 28
    • 85014913304 scopus 로고    scopus 로고
    • Accessed 11 Mar
    • National Institute for Health and Care Excellence. https://cks.nice.org.uk/sore-throat-acute#!topicsummary. Accessed 11 Mar 2017.
    • (2017)
  • 29
    • 69449108666 scopus 로고    scopus 로고
    • Amantadine, oseltamivir and zanamivir for the treatment of influenza: technology appraisal guidance
    • NICE guideline TA168. London: NICE. Accessed 28 Dec 2016
    • National Institute for Health and Care Excellence (NICE). Amantadine, oseltamivir and zanamivir for the treatment of influenza: technology appraisal guidance. NICE guideline TA168. London: NICE; 2009. https://www.nice.org.uk/Guidance/ta168. Accessed 28 Dec 2016.
    • (2009)
  • 30
    • 84971508909 scopus 로고    scopus 로고
    • Neuraminidase inhibitors for influenza: a systematic review and meta-analysis of regulatory and mortality data
    • Heneghan CJ, Onakpoya I, Jones MA, Doshi P, Del Mar CB, Hama R, et al. Neuraminidase inhibitors for influenza: a systematic review and meta-analysis of regulatory and mortality data. Health Technol Assess. 2016;20:(42). doi: 10.3310/hta20420.
    • (2016) Health Technol Assess. , vol.20 , Issue.42
    • Heneghan, C.J.1    Onakpoya, I.2    Jones, M.A.3    Doshi, P.4    Del Mar, C.B.5    Hama, R.6
  • 31
    • 80755169475 scopus 로고    scopus 로고
    • Risk factors and interventions with statistically significant tiny effects
    • Siontis GCM, Ioannidis JPA. Risk factors and interventions with statistically significant tiny effects. Int J Epidemiol. 2011;40:1292-307. doi: 10.1093/ije/dyr099.
    • (2011) Int J Epidemiol , vol.40 , pp. 1292-1307
    • Siontis, G.C.M.1    Ioannidis, J.P.A.2
  • 32
    • 17144375686 scopus 로고    scopus 로고
    • Expanding the definition of clinical differences: from minimally clinically important differences to really important differences: analyses in 8931 patients with rheumatoid arthritis
    • Wolfe F, Michaud K, Strand V. Expanding the definition of clinical differences: from minimally clinically important differences to really important differences: analyses in 8931 patients with rheumatoid arthritis. J Rheumatol. 2005;32:583-9.
    • (2005) J Rheumatol. , vol.32 , pp. 583-589
    • Wolfe, F.1    Michaud, K.2    Strand, V.3
  • 33
    • 84920982677 scopus 로고    scopus 로고
    • Efficacy and acceptability of pharmacological treatments for depressive disorders in primary care: systematic review and network meta-analysis
    • Linde K, Kriston L, Rücker G, Jamil S, Schumann I, Meissner K, et al. Efficacy and acceptability of pharmacological treatments for depressive disorders in primary care: systematic review and network meta-analysis. Ann Fam Med. 2015;13:69-79. doi: 10.1370/afm.1687.
    • (2015) Ann Fam Med , vol.13 , pp. 69-79
    • Linde, K.1    Kriston, L.2    Rücker, G.3    Jamil, S.4    Schumann, I.5    Meissner, K.6
  • 35
    • 84863527947 scopus 로고    scopus 로고
    • Potential impact on estimated treatment effects of information lost to follow-up in randomised controlled trials (LOST-IT): systematic review
    • Akl EA, Briel M, You JJ, Sun X, Johnston BC, Busse JW, et al. Potential impact on estimated treatment effects of information lost to follow-up in randomised controlled trials (LOST-IT): systematic review. BMJ. 2012;344:e2809. doi: 10.1136/bmj.e2809.
    • (2012) BMJ , vol.344
    • Akl, E.A.1    Briel, M.2    You, J.J.3    Sun, X.4    Johnston, B.C.5    Busse, J.W.6
  • 36
    • 84878458408 scopus 로고    scopus 로고
    • The prevention and handling of the missing data
    • Kang H. The prevention and handling of the missing data. Korean J Anesthesiol. 2013;64:402-6. doi: 10.4097/kjae.2013.64.5.402.
    • (2013) Korean J Anesthesiol , vol.64 , pp. 402-406
    • Kang, H.1
  • 37
    • 13344276585 scopus 로고
    • Is self-audit reliable?
    • Rothwell P, Warlow C. Is self-audit reliable? Lancet. 1995;346:1623. doi: 10.1016/s0140-6736(95)91953-8.
    • (1995) Lancet , vol.346 , pp. 1623
    • Rothwell, P.1    Warlow, C.2
  • 38
    • 84919808207 scopus 로고    scopus 로고
    • Extent of non-publication in cohorts of studies approved by research ethics committees or included in trial registries
    • Schmucker C, Schell LK, Portalupi S, Oeller P, Cabrera L, Bassler D, et al. Extent of non-publication in cohorts of studies approved by research ethics committees or included in trial registries. PLoS One. 2014;9:e114023. doi: 10.1371/journal.pone.0114023.
    • (2014) PLoS One , vol.9
    • Schmucker, C.1    Schell, L.K.2    Portalupi, S.3    Oeller, P.4    Cabrera, L.5    Bassler, D.6
  • 39
    • 72849132173 scopus 로고    scopus 로고
    • Dissemination and publication of research findings: an updated review of related biases
    • Song F, Parekh S, Hooper L, Loke YK, Ryder J, Sutton AJ, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess. 2010;14(8). doi: 10.3310/hta14080.
    • (2010) Health Technol Assess. , vol.14 , Issue.8
    • Song, F.1    Parekh, S.2    Hooper, L.3    Loke, Y.K.4    Ryder, J.5    Sutton, A.J.6
  • 40
    • 69349099139 scopus 로고    scopus 로고
    • Publication bias in clinical trials due to statistical significance or direction of trial results
    • MR000006
    • Hopewell S, Loudon K, Clarke MJ, Oxman AD, Dickersin K. Publication bias in clinical trials due to statistical significance or direction of trial results. Cochrane Database Syst Rev. 2009;1:MR000006. doi: 10.1002/14651858.MR000006.pub3.
    • (2009) Cochrane Database Syst Rev , vol.1
    • Hopewell, S.1    Loudon, K.2    Clarke, M.J.3    Oxman, A.D.4    Dickersin, K.5
  • 42
    • 85014916559 scopus 로고    scopus 로고
    • About AllTrials
    • Accessed 11 Mar
    • AllTrials. About AllTrials. http://www.alltrials.net/find-out-more/about-alltrials/. Accessed 11 Mar 2017.
    • (2017)
  • 43
    • 77949680683 scopus 로고    scopus 로고
    • The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews
    • Kirkham JJ, Dwan KM, Altman DG, Gamble C, Dodd S, Smyth R, et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ. 2010;340:c365. doi: 10.1136/bmj.c365.
    • (2010) BMJ , vol.340
    • Kirkham, J.J.1    Dwan, K.M.2    Altman, D.G.3    Gamble, C.4    Dodd, S.5    Smyth, R.6
  • 44
    • 84880059680 scopus 로고    scopus 로고
    • Reporting of industry funded study outcome data: comparison of confidential and published data on the safety and effectiveness of rhBMP-2 for spinal fusion
    • Rodgers MA, Brown JVE, Heirs MK, Higgins JPT, Mannion RJ, Simmonds MC, et al. Reporting of industry funded study outcome data: comparison of confidential and published data on the safety and effectiveness of rhBMP-2 for spinal fusion. BMJ. 2013;346:f3981. doi: 10.1136/bmj.f3981.
    • (2013) BMJ , vol.346
    • Rodgers, M.A.1    Brown, J.V.E.2    Heirs, M.K.3    Higgins, J.P.T.4    Mannion, R.J.5    Simmonds, M.C.6
  • 45
    • 84989902038 scopus 로고    scopus 로고
    • Reporting of adverse events in published and unpublished studies of health care interventions: a systematic review
    • Golder S, Loke YK, Wright K, Norman G. Reporting of adverse events in published and unpublished studies of health care interventions: a systematic review. PLoS Med. 2016;13:e1002127. doi: 10.1371/journal.pmed.1002127.
    • (2016) PLoS Med , vol.13
    • Golder, S.1    Loke, Y.K.2    Wright, K.3    Norman, G.4
  • 46
    • 84886614481 scopus 로고    scopus 로고
    • Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data
    • Wieseler B, Wolfram N, McGauran N, Kerekes MF, Vervölgyi V, Kohlepp P, et al. Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data. PLoS Med. 2013;10:e1001526. doi: 10.1371/journal.pmed.1001526.
    • (2013) PLoS Med , vol.10
    • Wieseler, B.1    Wolfram, N.2    McGauran, N.3    Kerekes, M.F.4    Vervölgyi, V.5    Kohlepp, P.6
  • 47
    • 84858996695 scopus 로고    scopus 로고
    • Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses
    • Hart B, Lundh A, Bero L. Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses. BMJ. 2012;344:d7202. doi: 10.1136/bmj.d7202.
    • (2012) BMJ , vol.344
    • Hart, B.1    Lundh, A.2    Bero, L.3
  • 48
    • 84988915868 scopus 로고    scopus 로고
    • Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis
    • Schroll JB, Penninga EI, Gøtzsche PC. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis. PLoS Med. 2016;13(8):e1002101. doi: 10.1371/journal.pmed.1002101.
    • (2016) PLoS Med. , vol.13 , Issue.8
    • Schroll, J.B.1    Penninga, E.I.2    Gøtzsche, P.C.3
  • 49
    • 70449633381 scopus 로고    scopus 로고
    • Outcome reporting in industry-sponsored trials of gabapentin for off-label use
    • Vedula SS, Bero L, Scherer RW, Dickersin K, et al. Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med. 2009;361:1963-71. doi: 10.1056/nejmsa0906126.
    • (2009) N Engl J Med , vol.361 , pp. 1963-1971
    • Vedula, S.S.1    Bero, L.2    Scherer, R.W.3    Dickersin, K.4
  • 50
    • 84912099186 scopus 로고    scopus 로고
    • Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews
    • Saini P, Loke YK, Gamble C, Altman DG, Williamson PR, Kirkham JJ. Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews. BMJ. 2014;349:g6501. doi: 10.1136/bmj.g6501.
    • (2014) BMJ , vol.349
    • Saini, P.1    Loke, Y.K.2    Gamble, C.3    Altman, D.G.4    Williamson, P.R.5    Kirkham, J.J.6
  • 51
    • 84959259456 scopus 로고    scopus 로고
    • PRISMA harms checklist: improving harms reporting in systematic reviews
    • Zorzela L, Loke YK, Ioannidis JP, Golder S, Santaguida P, Altman DG, et al. PRISMA harms checklist: improving harms reporting in systematic reviews. BMJ. 2016;352:i157. doi: 10.1136/bmj.i157. A published erratum appears in BMJ. 2016;353:i2229.
    • (2016) BMJ , vol.352
    • Zorzela, L.1    Loke, Y.K.2    Ioannidis, J.P.3    Golder, S.4    Santaguida, P.5    Altman, D.G.6
  • 52
    • 78751697239 scopus 로고    scopus 로고
    • Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists
    • Smyth RMD, Kirkham JJ, Jacoby A, Altman DG, Gamble C, Williamson PR. Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists. BMJ. 2011;342:c7153. doi: 10.1136/bmj.c7153.
    • (2011) BMJ , vol.342
    • Smyth, R.M.D.1    Kirkham, J.J.2    Jacoby, A.3    Altman, D.G.4    Gamble, C.5    Williamson, P.R.6
  • 53
    • 84903272310 scopus 로고    scopus 로고
    • Evidence for the selective reporting of analyses and discrepancies in clinical trials: a systematic review of cohort studies of clinical trials
    • Dwan K, Altman DG, Clarke M, Gamble C, Higgins JPT, Sterne JA, et al. Evidence for the selective reporting of analyses and discrepancies in clinical trials: a systematic review of cohort studies of clinical trials. PLoS Med. 2014;11:e1001666. doi: 10.1371/journal.pmed.1001666.
    • (2014) PLoS Med , vol.11
    • Dwan, K.1    Altman, D.G.2    Clarke, M.3    Gamble, C.4    Higgins, J.P.T.5    Sterne, J.A.6
  • 54
    • 84969909660 scopus 로고    scopus 로고
    • Feasibility study to examine discrepancy rates in prespecified and reported outcomes in articles submitted to The BMJ
    • Weston J, Dwan K, Altman D, Clarke M, Gamble C, Schroter S, et al. Feasibility study to examine discrepancy rates in prespecified and reported outcomes in articles submitted to The BMJ. BMJ Open. 2016;6:e010075. doi: 10.1136/bmjopen-2015-010075.
    • (2016) BMJ Open , vol.6
    • Weston, J.1    Dwan, K.2    Altman, D.3    Clarke, M.4    Gamble, C.5    Schroter, S.6
  • 56
    • 84867411377 scopus 로고    scopus 로고
    • Use of relative and absolute effect measures in reporting health inequalities: structured review
    • King NB, Harper S, Young ME. Use of relative and absolute effect measures in reporting health inequalities: structured review. BMJ. 2012;345:e5774. doi: 10.1136/bmj.e5774.
    • (2012) BMJ , vol.345
    • King, N.B.1    Harper, S.2    Young, M.E.3
  • 57
    • 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. doi: 10.1136/bmj.c332.
    • (2010) BMJ , vol.340
    • Schulz, K.F.1    Altman, D.G.2    Moher, D.3
  • 58
    • 84994558597 scopus 로고    scopus 로고
    • 'Spin' in reports of clinical research
    • Mahtani KR. 'Spin' in reports of clinical research. Evid Based Med. 2016;21:201-2. doi: 10.1136/ebmed-2016-110570.
    • (2016) Evid Based Med , vol.21 , pp. 201-202
    • Mahtani, K.R.1
  • 59
    • 77952787734 scopus 로고    scopus 로고
    • Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes
    • Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA. 2010;303:2058-64. doi: 10.1001/jama.2010.651.
    • (2010) JAMA , vol.303 , pp. 2058-2064
    • Boutron, I.1    Dutton, S.2    Ravaud, P.3    Altman, D.G.4
  • 60
    • 84919768013 scopus 로고    scopus 로고
    • Impact of spin in the abstracts of articles reporting results of randomized controlled trials in the field of cancer: the SPIIN randomized controlled trial
    • Boutron I, Altman DG, Hopewell S, Vera-Badillo F, Tannock I, Ravaud P. Impact of spin in the abstracts of articles reporting results of randomized controlled trials in the field of cancer: the SPIIN randomized controlled trial. J Clin Oncol. 2014;32:4120-6. doi: 10.1200/jco.2014.56.7503.
    • (2014) J Clin Oncol , vol.32 , pp. 4120-4126
    • Boutron, I.1    Altman, D.G.2    Hopewell, S.3    Vera-Badillo, F.4    Tannock, I.5    Ravaud, P.6
  • 61
    • 84971268517 scopus 로고    scopus 로고
    • Conflicts of interest and spin in reviews of psychological therapies: a systematic review
    • Lieb K, von der Osten-Sacken J, Stoffers-Winterling J, Reiss N, Barth J. Conflicts of interest and spin in reviews of psychological therapies: a systematic review. BMJ Open. 2016;6:e010606. doi: 10.1136/bmjopen-2015-010606.
    • (2016) BMJ Open , vol.6
    • Lieb, K.1    Osten-Sacken, J.2    Stoffers-Winterling, J.3    Reiss, N.4    Barth, J.5
  • 62
    • 84959168735 scopus 로고    scopus 로고
    • A new classification of spin in systematic reviews and meta-analyses was developed and ranked according to the severity
    • Yavchitz A, Ravaud P, Altman DG, Moher D, Hróbjartsson A, Lasserson T, et al. A new classification of spin in systematic reviews and meta-analyses was developed and ranked according to the severity. J Clin Epidemiol. 2016;75:56-65. doi: 10.1016/j.jclinepi.2016.01.020.
    • (2016) J Clin Epidemiol , vol.75 , pp. 56-65
    • Yavchitz, A.1    Ravaud, P.2    Altman, D.G.3    Moher, D.4    Hróbjartsson, A.5    Lasserson, T.6
  • 63
    • 0141918127 scopus 로고    scopus 로고
    • Points to consider on multiplicity issues in clinical trials
    • CPMP/EWP/908/99. 19 Sep. Accessed 11 Mar 2017
    • European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products. Points to consider on multiplicity issues in clinical trials. CPMP/EWP/908/99. 19 Sep 2002. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003640.pdf. Accessed 11 Mar 2017.
    • (2002)
  • 64
    • 84859726995 scopus 로고    scopus 로고
    • Credibility of claims of subgroup effects in randomised controlled trials: systematic review
    • Sun X, Briel M, Busse JW, You JJ, Akl EA, Mejza F, et al. Credibility of claims of subgroup effects in randomised controlled trials: systematic review. BMJ. 2012;344:e1553. doi: 10.1136/bmj.e1553.
    • (2012) BMJ , vol.344
    • Sun, X.1    Briel, M.2    Busse, J.W.3    You, J.J.4    Akl, E.A.5    Mejza, F.6
  • 65
    • 84864503158 scopus 로고    scopus 로고
    • Developing core outcome sets for clinical trials: issues to consider
    • Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13:132. doi: 10.1186/1745-6215-13-132.
    • (2012) Trials , vol.13 , pp. 132
    • Williamson, P.R.1    Altman, D.G.2    Blazeby, J.M.3    Clarke, M.4    Devane, D.5    Gargon, E.6
  • 66
    • 37749041179 scopus 로고    scopus 로고
    • OMERACT: an international initiative to improve outcome measurement in rheumatology
    • Tugwell P, Boers M, Brooks P, Simon L, Strand V, Idzerda L. OMERACT: an international initiative to improve outcome measurement in rheumatology. Trials. 2007;8:38. doi: 10.1186/1745-6215-8-38.
    • (2007) Trials , vol.8 , pp. 38
    • Tugwell, P.1    Boers, M.2    Brooks, P.3    Simon, L.4    Strand, V.5    Idzerda, L.6
  • 67
    • 85032043699 scopus 로고    scopus 로고
    • The COMET Initiative [abstract]
    • Williamson P. The COMET Initiative [abstract]. Trials. 2013;14 Suppl 1:O65. doi: 10.1186/1745-6215-14-s1-o65.
    • (2013) Trials , vol.14 , pp. O65
    • Williamson, P.1
  • 68
    • 84947867210 scopus 로고    scopus 로고
    • The COMET Initiative database: progress and activities update (2014)
    • Gargon E, Williamson PR, Altman DG, Blazeby JM, Clarke M. The COMET Initiative database: progress and activities update (2014). Trials. 2015;16:515. doi: 10.1186/s13063-015-1038-x.
    • (2015) Trials , vol.16 , pp. 515
    • Gargon, E.1    Williamson, P.R.2    Altman, D.G.3    Blazeby, J.M.4    Clarke, M.5
  • 69
    • 85014910535 scopus 로고    scopus 로고
    • Accessed 11 Mar
    • Grading of Recommendations Assessment, Development and Evaluation (GRADE). http://www.gradeworkinggroup.org/. Accessed 11 Mar 2017.
    • (2017)
  • 70
    • 84947715315 scopus 로고    scopus 로고
    • Brayne C; Dementia Priority Setting Partnership. Dementia priority setting partnership with the James Lind Alliance: using patient and public involvement and the evidence base to inform the research agenda
    • Kelly S, Lafortune L, Hart N, Cowan K, Fenton M. Brayne C; Dementia Priority Setting Partnership. Dementia priority setting partnership with the James Lind Alliance: using patient and public involvement and the evidence base to inform the research agenda. Age Ageing. 2015;44:985-93. doi: 10.1093/ageing/afv143.
    • (2015) Age Ageing , vol.44 , pp. 985-993
    • Kelly, S.1    Lafortune, L.2    Hart, N.3    Cowan, K.4    Fenton, M.5


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