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Volumn 6, Issue , 2014, Pages 981-993

Quality assessment of observational studies in a drug-safety systematic review, Comparison of two tools: The Newcastle-Ottawa scale and the RTI item bank

Author keywords

AC1; Meta analysis; Quality assessment; Systematic review

Indexed keywords

ANTIDIABETIC AGENT;

EID: 84907862051     PISSN: None     EISSN: 11791349     Source Type: Journal    
DOI: 10.2147/CLEP.S66677     Document Type: Article
Times cited : (358)

References (47)
  • 1
    • 84860257850 scopus 로고    scopus 로고
    • Section 13.5.2.3. Tools for assessing methodological quality or risk of bias in non-randomized studies
    • editors, London: The Cochrane Collaboration
    • Higgins JP., Green S, editors. Section 13.5.2.3. Tools for assessing methodological quality or risk of bias in non-randomized studies. In: Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0. London: The Cochrane Collaboration; 2011.
    • (2011) Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0
    • Higgins, J.P.1    Green, S.2
  • 2
    • 84865147673 scopus 로고    scopus 로고
    • (Report No: 12-EHC039-EF). Rockville, MD: Agency for Healthcare Research and Quality (US), Available from, Accessed June 24, 2013
    • Hartling L, Hamm M, Milne A, et al. Validity and Inter-Rater Reliability Testing of Quality Assessment Instruments (Report No: 12-EHC039-EF). Rockville, MD: Agency for Healthcare Research and Quality (US); 2012. Available from: http://www.ncbi.nlm.nih.gov/books/NBK92293/. Accessed June 24, 2013.
    • (2012) Validity and Inter-Rater Reliability Testing of Quality Assessment Instruments
    • Hartling, L.1    Hamm, M.2    Milne, A.3
  • 3
    • 0010277487 scopus 로고    scopus 로고
    • On the bias produced by quality scores in meta-analysis, and a hierarchical view of proposed solutions
    • Greenland S, O’Rourke K. On the bias produced by quality scores in meta-analysis, and a hierarchical view of proposed solutions. Biostatistics. 2001;2(4):463-471.
    • (2001) Biostatistics , vol.2 , Issue.4 , pp. 463-471
    • Greenland, S.1    O’rourke, K.2
  • 4
    • 84869828902 scopus 로고    scopus 로고
    • Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies
    • Neyarapally GA, Hammad TA, Pinheiro SP, Iyasu S. Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies. BMJ Open. 2012;2(5).
    • (2012) BMJ Open , vol.2 , Issue.5
    • Neyarapally, G.A.1    Hammad, T.A.2    Pinheiro, S.P.3    Iyasu, S.4
  • 5
    • 34547851792 scopus 로고    scopus 로고
    • Tools for assessing quality and susceptibility to bias in observational studies in epidemiology: A systematic review and annotated bibliography
    • Sanderson S, Tatt ID, Higgins JP. Tools for assessing quality and susceptibility to bias in observational studies in epidemiology: a systematic review and annotated bibliography. Int J Epidemiol. 2007;36(3):666-676.
    • (2007) Int J Epidemiol , vol.36 , Issue.3 , pp. 666-676
    • Sanderson, S.1    Tatt, I.D.2    Higgins, J.P.3
  • 6
    • 0141870148 scopus 로고    scopus 로고
    • Evaluating non-randomised intervention studies
    • International Stroke Trial Collaborative Group; European Carotid Sugery Trial Collaborative Group, iii-x
    • Deeks JJ, Dinnes J, D’Amico R, et al; International Stroke Trial Collaborative Group; European Carotid Sugery Trial Collaborative Group. Evaluating non-randomised intervention studies. Health Technol Assess. 2003;7(27):iii-x, 1-173.
    • (2003) Health Technol Assess , vol.7 , Issue.27 , pp. 1-173
    • Deeks, J.J.1    Dinnes, J.2    D’amico, R.3
  • 8
    • 84907872894 scopus 로고    scopus 로고
    • SOS, Available from, Accessed June 24, 2013
    • SOS. Safety of NSAIDs [homepage on the Internet]. 2013. Available from: http://www.sos-nsaids-project.org/. Accessed June 24, 2013.
    • (2013) Safety of NSAIDs [homepage on the Internet]
  • 9
    • 84868621108 scopus 로고    scopus 로고
    • Safety of Non-Steroidal Anti-Inflammatory Drugs (SOS) Project. Individual NSAIDs and upper gastrointestinal complications: A systematic review and meta-analysis of observational studies (the SOS project)
    • Castellsague J, Riera-Guardia N, Calingaert B, et al; Safety of Non-Steroidal Anti-Inflammatory Drugs (SOS) Project. Individual NSAIDs and upper gastrointestinal complications: a systematic review and meta-analysis of observational studies (the SOS project). Drug Saf. 2012;35(12):1127-1146.
    • (2012) Drug Saf , vol.35 , Issue.12 , pp. 1127-1146
    • Castellsague, J.1    Riera-guardia, N.2    Calingaert, B.3
  • 10
    • 81955164820 scopus 로고    scopus 로고
    • Stroke risk and NSAIDs: A systematic review of observational studies
    • Varas-Lorenzo C, Riera-Guardia N, Calingaert B, et al. Stroke risk and NSAIDs: a systematic review of observational studies. Pharmacoepidemiol Drug Saf. 2011;20(12):1225-1236.
    • (2011) Pharmacoepidemiol Drug Saf , vol.20 , Issue.12 , pp. 1225-1236
    • Varas-lorenzo, C.1    Riera-guardia, N.2    Calingaert, B.3
  • 11
    • 84878800652 scopus 로고    scopus 로고
    • Myocardial infarction and individual nonsteroidal anti-inflammatory drugs meta-analysis of observational studies
    • Varas-Lorenzo C, Riera-Guardia N, Calingaert B, et al. Myocardial infarction and individual nonsteroidal anti-inflammatory drugs meta-analysis of observational studies. Pharmacoepidemiol Drug Saf. 2013;22(6):559-570.
    • (2013) Pharmacoepidemiol Drug Saf , vol.22 , Issue.6 , pp. 559-570
    • Varas-lorenzo, C.1    Riera-guardia, N.2    Calingaert, B.3
  • 14
    • 84855350542 scopus 로고    scopus 로고
    • Development of the RTI item bank on risk of bias and precision of observational studies
    • Viswanathan M, Berkman ND. Development of the RTI item bank on risk of bias and precision of observational studies. J Clin Epidemiol. 2012;65(2):163-178.
    • (2012) J Clin Epidemiol , vol.65 , Issue.2 , pp. 163-178
    • Viswanathan, M.1    Berkman, N.D.2
  • 15
    • 84907875237 scopus 로고    scopus 로고
    • Cardiovascular risk with glitazones and metformin: Results from a systematic review of observational studies
    • Varas-Lorenzo C, Riera-Guardia N, Calingaert B, et al. Cardiovascular risk with glitazones and metformin: results from a systematic review of observational studies. Pharmacoepidemiol Drug Saf. 2013;22(Suppl 1):S68.
    • (2013) Pharmacoepidemiol Drug Saf , vol.22 , Issue.Suppl1 , pp. S68
    • Varas-lorenzo, C.1    Riera-guardia, N.2    Calingaert, B.3
  • 16
    • 84907874414 scopus 로고    scopus 로고
    • Rosiglitazone vs pioglitazone and acute myocardial infarction: Systematic review and meta-analysis of observational studies
    • Pladevall M, Varas-Lorenzo C, Margulis AV, et al. Rosiglitazone vs pioglitazone and acute myocardial infarction: systematic review and meta-analysis of observational studies. Pharmacoepidemiol Drug Saf. 2013;22(Suppl 1):S181-S182.
    • (2013) Pharmacoepidemiol Drug Saf , vol.22 , Issue.Suppl1 , pp. S181-S182
    • Pladevall, M.1    Varas-lorenzo, C.2    Margulis, A.V.3
  • 17
    • 77957661914 scopus 로고    scopus 로고
    • Critical evaluation of the Newcastle-Ottawa Scale for the assessment of the quality of nonrandomized studies in meta-analyses
    • Stang A. Critical evaluation of the Newcastle-Ottawa Scale for the assessment of the quality of nonrandomized studies in meta-analyses. Eur J Epidemiol. 2010;25(9):603-605.
    • (2010) Eur J Epidemiol , vol.25 , Issue.9 , pp. 603-605
    • Stang, A.1
  • 18
    • 84865122567 scopus 로고    scopus 로고
    • Inter-rater and test-retest reliability of quality assessments by novice student raters using the Jadad and Newcastle-Ottawa Scales
    • ECT and Cognition Systematic Review Team
    • Oremus M, Oremus C, Hall GB, McKinnon MC; ECT and Cognition Systematic Review Team. Inter-rater and test-retest reliability of quality assessments by novice student raters using the Jadad and Newcastle-Ottawa Scales. BMJ Open. 2012;2(4).
    • (2012) BMJ Open , vol.2 , Issue.4
    • Oremus, M.1    Oremus, C.2    Hall, G.B.3    McKinnon, M.C.4
  • 19
    • 84882846134 scopus 로고    scopus 로고
    • Testing the Newcastle Ottawa Scale showed low reliability between individual reviewers
    • Hartling L, Milne A, Hamm MP, et al. Testing the Newcastle Ottawa Scale showed low reliability between individual reviewers. J Clin Epidemiol. 2013;66(9):982-993.
    • (2013) J Clin Epidemiol , vol.66 , Issue.9 , pp. 982-993
    • Hartling, L.1    Milne, A.2    Hamm, M.P.3
  • 20
    • 65449143889 scopus 로고    scopus 로고
    • Classification and appraisal of the level of clinical evidence of publications from the Canadian Association of Pediatric Surgeons for the past 10 years
    • Al-Harbi K, Farrokhyar F, Mulla S, Fitzgerald P. Classification and appraisal of the level of clinical evidence of publications from the Canadian Association of Pediatric Surgeons for the past 10 years. J Pediatr Surg. 2009;44(5):1013-1017.
    • (2009) J Pediatr Surg , vol.44 , Issue.5 , pp. 1013-1017
    • Al-harbi, K.1    Farrokhyar, F.2    Mulla, S.3    Fitzgerald, P.4
  • 21
    • 84862668656 scopus 로고    scopus 로고
    • Impact of H1N1 on socially disadvantaged populations: Systematic review
    • Tricco AC, Lillie E, Soobiah C, Perrier L, Straus SE. Impact of H1N1 on socially disadvantaged populations: systematic review. PLoS One. 2012;7(6):e39437.
    • (2012) PLoS One , vol.7 , Issue.6 , pp. e39437
    • Tricco, A.C.1    Lillie, E.2    Soobiah, C.3    Perrier, L.4    Straus, S.E.5
  • 22
    • 74549217003 scopus 로고    scopus 로고
    • The effect of intramural fibroids without uterine cavity involvement on the outcome of IVF treatment: A systematic review and meta-analysis
    • Sunkara SK, Khairy M, El-Toukhy T, Khalaf Y, Coomarasamy A. The effect of intramural fibroids without uterine cavity involvement on the outcome of IVF treatment: a systematic review and meta-analysis. Hum Reprod. 2010;25(2):418-429.
    • (2010) Hum Reprod , vol.25 , Issue.2 , pp. 418-429
    • Sunkara, S.K.1    Khairy, M.2    El-toukhy, T.3    Khalaf, Y.4    Coomarasamy, A.5
  • 23
    • 84862649931 scopus 로고    scopus 로고
    • Effects of hyperuricemia on renal function of renal transplant recipients: A systematic review and meta-analysis of cohort studies
    • Huang Y, Li YL, Huang H, Wang L, Yuan WM, Li J. Effects of hyperuricemia on renal function of renal transplant recipients: a systematic review and meta-analysis of cohort studies. PLoS One. 2012;7(6):e39457.
    • (2012) PLoS One , vol.7 , Issue.6 , pp. e39457
    • Huang, Y.1    Li, Y.L.2    Huang, H.3    Wang, L.4    Yuan, W.M.5    Li, J.6
  • 24
    • 80055005734 scopus 로고    scopus 로고
    • Systematic review with meta-analysis: Cytokines in fibromyalgia syndrome
    • Uçeyler N, Häuser W, Sommer C. Systematic review with meta-analysis: cytokines in fibromyalgia syndrome. BMC Musculoskelet Disord. 2011;12:245.
    • (2011) BMC Musculoskelet Disord , vol.12 , pp. 245
    • Uçeyler, N.1    Häuser, W.2    Sommer, C.3
  • 25
    • 84859001212 scopus 로고    scopus 로고
    • Cochrane Bias Methods Group; Cochrane Statistical Methods Group. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials
    • Higgins JP, Altman DG, Gøtzsche PC, et al; Cochrane Bias Methods Group; Cochrane Statistical Methods Group. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.
    • (2011) BMJ , vol.343 , pp. d5928
    • Higgins, J.P.1    Altman, D.G.2    Gøtzsche, P.C.3
  • 27
    • 84868219363 scopus 로고    scopus 로고
    • Morphologic and functional changes in the temporomandibular joint and stomatognathic system after transmandibular surgery in oral and oropharyngeal cancers: Systematic review
    • Al-Saleh MA, Armijo-Olivo S, Thie N, et al. Morphologic and functional changes in the temporomandibular joint and stomatognathic system after transmandibular surgery in oral and oropharyngeal cancers: systematic review. J Otolaryngol Head Neck Surg. 2012;41(5):345-360.
    • (2012) J Otolaryngol Head Neck Surg , vol.41 , Issue.5 , pp. 345-360
    • Al-saleh, M.A.1    Armijo-olivo, S.2    Thie, N.3
  • 28
    • 84874015672 scopus 로고    scopus 로고
    • Does postural sway change in association with manual therapeutic interventions? A review of the literature
    • Ruhe A, Fejer R, Walker B. Does postural sway change in association with manual therapeutic interventions? A review of the literature. Chiropr Man Therap. 2013;21(1):9.
    • (2013) Chiropr Man Therap , vol.21 , Issue.1 , pp. 9
    • Ruhe, A.1    Fejer, R.2    Walker, B.3
  • 29
    • 33947227921 scopus 로고    scopus 로고
    • Immortal time bias in observational studies of drug effects
    • Suissa S. Immortal time bias in observational studies of drug effects. Pharmacoepidemiol Drug Saf. 2007;16(3):241-249.
    • (2007) Pharmacoepidemiol Drug Saf , vol.16 , Issue.3 , pp. 241-249
    • Suissa, S.1
  • 30
    • 0030187757 scopus 로고    scopus 로고
    • Confounding by indication
    • Walker AM. Confounding by indication. Epidemiology. 1996;7(4): 335-336.
    • (1996) Epidemiology , vol.7 , Issue.4 , pp. 335-336
    • Walker, A.M.1
  • 31
    • 44349101004 scopus 로고    scopus 로고
    • Computing inter-rater reliability and its variance in the presence of high agreement
    • Gwet KL. Computing inter-rater reliability and its variance in the presence of high agreement. Br J Math Stat Psychol. 2008;61(Pt 1): 29-48.
    • (2008) Br J Math Stat Psychol , vol.61 , Issue.Pt1 , pp. 29-48
    • Gwet, K.L.1
  • 32
    • 18544372466 scopus 로고    scopus 로고
    • Understanding interobserver agreement: The kappa statistic
    • Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005;37(5):360-363.
    • (2005) Fam Med , vol.37 , Issue.5 , pp. 360-363
    • Viera, A.J.1    Garrett, J.M.2
  • 33
    • 84876804850 scopus 로고    scopus 로고
    • A comparison of Cohen’s Kappa and Gwet’s AC1 when calculating inter-rater reliability coefficients: A study conducted with personality disorder samples
    • Wongpakaran N, Wongpakaran T, Wedding D, Gwet KL. A comparison of Cohen’s Kappa and Gwet’s AC1 when calculating inter-rater reliability coefficients: a study conducted with personality disorder samples. BMC Med Res Methodol. 2013;13:61.
    • (2013) BMC Med Res Methodol , vol.13 , pp. 61
    • Wongpakaran, N.1    Wongpakaran, T.2    Wedding, D.3    Gwet, K.L.4
  • 35
    • 84907872893 scopus 로고    scopus 로고
    • SAS Global Forum 2007: Statistics and Data Analysis. Paper 186-2007. Available from, Accessed October 15
    • Blood E, Spratt KF. Disagreement on Agreement: Two Alternative Agreement Coefficients. SAS Global Forum 2007: Statistics and Data Analysis. Paper 186-2007. Available from: http://www2.sas.com/proceedings/forum2007/186-2007.pdf. Accessed October 15, 2012.
    • (2012) Disagreement on Agreement: Two Alternative Agreement Coefficients
  • 36
    • 84870006267 scopus 로고    scopus 로고
    • PEDro’s bias: Summary quality scores should not be used in meta-analysis
    • da Costa BR, Hilfiker R, Egger M. PEDro’s bias: summary quality scores should not be used in meta-analysis. J Clin Epidemiol. 2013; 66(1):75-77.
    • (2013) J Clin Epidemiol , vol.66 , Issue.1 , pp. 75-77
    • Da Costa, B.R.1    Hilfiker, R.2    Egger, M.3
  • 37
    • 79951955368 scopus 로고    scopus 로고
    • GRADE guidelines: 4. Rating the quality of evidence - study limitations (risk of bias)
    • Guyatt GH, Oxman AD, Vist G, et al. GRADE guidelines: 4. Rating the quality of evidence - study limitations (risk of bias). J Clin Epidemiol. 2011;64(4):407-415.
    • (2011) J Clin Epidemiol , vol.64 , Issue.4 , pp. 407-415
    • Guyatt, G.H.1    Oxman, A.D.2    Vist, G.3
  • 38
    • 84878261195 scopus 로고    scopus 로고
    • The GRADE approach is reproducible in assessing the quality of evidence of quantitative evidence syntheses
    • quiz 742. e1
    • Mustafa RA, Santesso N, Brozek J, et al. The GRADE approach is reproducible in assessing the quality of evidence of quantitative evidence syntheses. J Clin Epidemiol. 2013;66(7):736-742; quiz 742. e1.
    • (2013) J Clin Epidemiol , vol.66 , Issue.7 , pp. 736-742
    • Mustafa, R.A.1    Santesso, N.2    Brozek, J.3
  • 39
    • 0038439242 scopus 로고    scopus 로고
    • Pharmaceutical industry sponsorship and research outcome and quality: Systematic review
    • Lexchin J, Bero L., Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 2003;326(7400):1167-1170.
    • (2003) BMJ , vol.326 , Issue.7400 , pp. 1167-1170
    • Lexchin, J.1    Bero, L.2    Djulbegovic, B.3    Clark, O.4
  • 40
    • 39049096171 scopus 로고    scopus 로고
    • Pharmaceutical company funding and its consequences: A qualitative systematic review
    • Sismondo S. Pharmaceutical company funding and its consequences: a qualitative systematic review. Contemp Clin Trials. 2008;29(2): 109-113.
    • (2008) Contemp Clin Trials , vol.29 , Issue.2 , pp. 109-113
    • Sismondo, S.1
  • 41
    • 56549110284 scopus 로고    scopus 로고
    • Is there evidence for biased reporting of published adverse effects data in pharmaceutical industry-funded studies?
    • Golder S, Loke YK. Is there evidence for biased reporting of published adverse effects data in pharmaceutical industry-funded studies? Br J Clin Pharmacol. 2008;66(6):767-773.
    • (2008) Br J Clin Pharmacol , vol.66 , Issue.6 , pp. 767-773
    • Golder, S.1    Loke, Y.K.2
  • 42
    • 77952688070 scopus 로고    scopus 로고
    • The financing of drug trials by pharmaceutical companies and its consequences. Part 1: A qualitative, systematic review of the literature on possible influences on the findings, protocols, and quality of drug trials
    • Schott G, Pachl H, Limbach U, Gundert-Remy U, Ludwig WD, Lieb K. The financing of drug trials by pharmaceutical companies and its consequences. Part 1: a qualitative, systematic review of the literature on possible influences on the findings, protocols, and quality of drug trials. Dtsch Arztebl Int. 2010;107(16):279-285.
    • (2010) Dtsch Arztebl Int , vol.107 , Issue.16 , pp. 279-285
    • Schott, G.1    Pachl, H.2    Limbach, U.3    Gundert-remy, U.4    Ludwig, W.D.5    Lieb, K.6
  • 44
    • 84897368196 scopus 로고    scopus 로고
    • Why the Cochrane risk of bias tool should include funding source as a standard item
    • Bero LA. Why the Cochrane risk of bias tool should include funding source as a standard item. Cochrane Database Syst Rev. 2013;12: ED000075.
    • (2013) Cochrane Database Syst Rev , vol.12 , pp. ED000075
    • Bero, L.A.1
  • 45
    • 84897368189 scopus 로고    scopus 로고
    • Why the Cochrane risk of bias tool should not include funding source as a standard item
    • Sterne JA. Why the Cochrane risk of bias tool should not include funding source as a standard item. Cochrane Database Syst Rev. 2013;12: ED000076.
    • (2013) Cochrane Database Syst Rev , vol.12 , pp. ED000076
    • Sterne, J.A.1
  • 46
    • 79955071823 scopus 로고    scopus 로고
    • With great data comes great responsibility: Publishing comparative effectiveness research in epidemiology
    • Hernán MA. With great data comes great responsibility: publishing comparative effectiveness research in epidemiology. Epidemiology. 2011;22(3):290-291.
    • (2011) Epidemiology , vol.22 , Issue.3 , pp. 290-291
    • Hernán, M.A.1


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