Abstract
Objective
To establish the CQS inter-rater reliability and rating time and to compare both against that of the Jadad scale and Cochrane’s Risk of Bias Tool (ROBT).
Material and methods
Four independent raters rated 45 trial reports. The inter-rater reliability was established by use of the Brennan-Prediger coefficient (BPC). The coefficients were compared using the two-sample z-test. Secondary analysis included comparison of the inter-rater reliability of the randomization component of all tools, as well as of the allocation concealment component of the CQS to that of the ROBT. The mean rating time with standard deviation (SD) for each tool was determined using one-way repeated measures analysis of variance. Post hoc comparisons were made using the Tukey–Kramer adjustment for three pair-wise multiple comparisons.
Results
The inter-rater reliability was significantly higher for the CQS (BPC, 95% CI: 0.95, 0.87–1.00) compared to Jadad (0.70, 0.58–0.82) (adjusted p = 0.0005) and most components of ROBT. The mean (SD) time to complete the CQS (4.0 (1.0) min) did not differ significantly from that of the Jadad scale 4.8 (1.1) min (adjusted p = 0.11), but was significantly shorter compared to that of the ROBT 15.3 (5.9) min (adjusted p < 0.0001).
Conclusions
The results suggest the CQS to be a very reliable and fast trial appraisal tool.
Clinical relevance
The higher the inter-rater reliability, the higher the probability that trial results reflect therapeutic truth. The CQS will need to take further bias sources into consideration, in order to increase its utility.
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References
Akobeng AK (2008) Assessing the validity of clinical trials. J Pediatr Gastroenterol Nutr 47:277–282. https://doi.org/10.1097/MPG.0b013e31816c749f
Mickenautsch S, Berger VW (2019) The role of the randomised controlled trial in restorative dentistry and the correct purpose of observational data. Br Dent J. https://doi.org/10.1038/sj.bdj.2019.43
Mickenautsch S, Yengopal V (2013) Direct contra naïve-indirect comparison of clinical failure rates between high-viscosity GIC and conventional amalgam restorations: an empirical study. PLoS ONE 8:e78397. https://doi.org/10.1371/journal.pone.0078397
Odgaard-Jensen J, Vist GE, Timmer A, Kunz R, Akl EA, Schünemann H, Briel M, Nordmann AJ, Pregno S, Oxman AD (2011) Randomisation to protect against selection bias in healthcare trials. Cochrane Database Syst Rev 4:MR000012. https://doi.org/10.1002/14651858.MR000012.pub3
Mickenautsch S (2020) Are most of the published clinical trial results in restorative dentistry invalid? - An Empirical Investigation. Rev Recent Clin Trials 15:122–130. https://doi.org/10.2174/1574887115666200421110732
Jadad AR, Moore RA, Carroll D et al (1996) Assessing the quality of reports of randomized clinical trials: is blinding necessary? Controlled Clin Trials 17:1–12. https://doi.org/10.1016/0197-2456(95)00134-4
Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, Savovic J, Schulz KF, Weeks L, Sterne JA; Cochrane Bias Methods Group; Cochrane Statistical Methods Group (2011) The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ 343:d5928. https://doi.org/10.1136/bmj.d5928
Berger VW (2006) Is the Jadad score the proper evaluation of trials? J Rheumatol 33:1710–1712
Clark HD, Wells GA, Huët C, McAlister FA, Salmi LR, Fergusson D, Laupacis A (1999) Assessing the quality of randomized trials: reliability of the Jadad scale. Control Clin Trials 20:448–452. https://doi.org/10.1016/s0197-2456(99)00026-4
Hartling L, Bond K, Vandermeer B, Seida J, Dryden DM, Rowe BH (2011) Applying the risk of bias tool in a systematic review of combination long-acting beta-agonists and inhaled corticosteroids for persistent asthma. PLoS ONE 6:e17242. https://doi.org/10.1371/journal.pone.0017242
Hartling L, Hamm MP, Milne A et al (2013) Testing the risk of bias tool showed low reliability between individual reviewers and across consensus assessments of reviewer pairs. J Clin Epidemiol 66:973–981. https://doi.org/10.1016/j.jclinepi.2012.07.005
Gwet KL (2010) Handbook of inter-rater reliability. (2nd ed.) Advanced Analytics, LLC: Gainsburg, MD, USA pp. 54, 159-160
Mickenautsch S (2020) Reports of controlled clinical trials for directly placed restorations in vital teeth published between 1990 – 2015: References of trial reports per calendar year. Dataset: 10.6084/m9.figshare.12310841.v1
Website. Random Number Generator. Available from http://www.randomnumbergenerator.com (accessed: May 15, 2020)
Website. Random Number Generator. Available from http://www.randomdraws.com/ (accessed: May 17, 2020)
Pocock SJ (1988) Clinical trials. A practical approach. John Wiley & Sons Ltd, Chichester, pp 126–134
Geigy (1970) Scientific tables, 7th ed. Geigy: Basle p. 28
SAS Institute Inc., SAS Software, version 9.4 for Windows, Cary, NC, USA: SAS Institute Inc. (2002-2012)
Landis JR, Koch GG (1977) The measurement of observer agreement for categorical data. Biometrics 33:159–174
Berger VW, Alperson SY (2009) A general framework for the evaluation of clinical trial quality. Rev Recent Clin Trials 4:79–88. https://doi.org/10.2174/157488709788186021
Bérard A, Andreu N, Tétrault J, Niyonsenga T, Myhal D (2000) Reliability of Chalmers’ scale to assess quality in meta-analyses on pharmacological treatments for osteoporosis. Ann Epidemiol 10:498–503. https://doi.org/10.1016/s1047-2797(00)00069-7
Glenny AM, Altman DG, Song F, Sakarovitch C, Deeks JJ, D’Amico R, Bradburn M, Eastwood AJ; International Stroke Trial Collaborative Group (2005) Indirect comparisons of competing interventions. Health Technol Assess 9:1–134
Alperson SY, Berger VW (2011) Opposing systematic reviews: the effects of two quality rating instruments on evidence regarding t’ai chi and bone mineral density in postmenopausal women. J Altern Complement Med 17:389–395. https://doi.org/10.3310/hta9260
Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, Cates CJ, Cheng HY, Corbett MS, Eldridge SM, Emberson JR, Hernán MA, Hopewell S, Hróbjartsson A, Junqueira DR, Jüni P, Kirkham JJ, Lasserson T, Li T, McAleenan A, Reeves BC, Shepperd S, Shrier I, Stewart LA, Tilling K, White IR, Whiting PF, Higgins JPT (2019) RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 366:l4898. https://doi.org/10.1136/bmj.l4898
Thomas J, Kneale D, McKenzie JE, Brennan SE, Bhaumik S (2020) Chapter 2: Determining the scope of the review and the questions it will address. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.1 (updated September 2020). Cochrane. Available from www.training.cochrane.org/handbook
Deeks JJ, Higgins JPT, Altman DG (editors). Chapter 10: Analysing data and undertaking meta-analyses. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors) (2019) Cochrane Handbook for Systematic Reviews of Interventions version 6.0 (updated July 2019). Cochrane. Available from www.training.cochrane.org/handbook
Acknowledgements
The authors thank Dr Petra Gaylard from DMSA for her valuable advice concerning data statistics and for conducting the data analysis.
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SM: conceptualization, methodology, data curation, writing—original draft, supervision. IM: investigation, writing—review & editing. SR: investigation, writing—review & editing. JR: investigation, writing—review & editing. GG: investigation, writing—review & editing.
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Mickenautsch, S., Miletić, I., Rupf, S. et al. The Composite Quality Score (CQS) as a trial appraisal tool: inter-rater reliability and rating time. Clin Oral Invest 25, 6015–6023 (2021). https://doi.org/10.1007/s00784-021-04099-w
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DOI: https://doi.org/10.1007/s00784-021-04099-w