The reporting of randomized controlled trials in prosthodontics.

Asbjørn Jokstad · Marco AB Esposito · Paul Coulthard · Helen V Worthington

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Meta-analysis and systematic reviews Statistical Methods in Clinical Trials Clinical practice guidelines implementation

Abstract

PURPOSE: This article evaluates the reporting of randomized controlled trials (RCT) in prosthodontics, excluding endosseous implant-based prosthetics. MATERIALS AND METHODS: Reports of RCTs published to the end of 2000 in any language were identified using a multilayered search strategy. The Cochrane Oral Health Group specialized register, Medline, and personal libraries were searched. Three researchers appraised the articles independently using guidelines following Jadad and CONSORT, complemented with an evaluation of the appropriateness of the reported statistics. RESULTS: Ninety-two reports of RCTs were evaluated, covering a wide spectrum of study hypotheses, topics, and issues within various prosthodontic domains. The interrater agreements on appraisal criteria were relatively high, with median kappa values ranging between 0.65 and 0.79. The reports were in general of poor methodologic quality. Randomization and procedures for concealment allocation were not described in 70% of the articles. The methods used to generate the random allocation sequence were not mentioned in 82%. The methods used to implement the random allocation sequence, clarifying whether it was concealed until all interventions were assigned, was not mentioned in 94%. Reporting who generated allocation sequence, who enrolled patients, and who assigned participants to groups was not reported in 7%. Reasons for withdrawals were not given in 23% of the reports. No attempt at blinding was reported in 72%. Statistical analysis was not described in 6% of the papers, while these analyses were assessed as appropriate for 75%, unclear in 12%, and inappropriate in 7%. CONCLUSION: Few RCTs in prosthodontics are reported in accordance with contemporary guidelines for adequate reporting of trials.

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References

1995Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials 2001The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials 1996Improving the quality of reporting of randomized controlled trials. The CONSORT statement 2001Assessing the quality of controlled clinical trials 1999The Hazards of Scoring the Quality of Clinical Trials for Meta-analysis 1987Confronting publication bias: A cohort design for meta‐analysis 2002Quality assessment of randomized controlled trials of oral implants.

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2014Are Sample Sizes Clear and Justified in RCTs Published in Dental Journals?2016A quality assessment of randomized controlled trial reports in endodontics 2015Reporting quality of randomised controlled trials published in prosthodontic and implantology journals 2012What’s in a title? An assessment of whether randomized controlled trial in a title means that it is one 2011Quality of randomised controlled trials in dentistry 2002

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