Seeking adverse effects in systematic reviews of orthodontic interventions: a cross-sectional study (part 1)

Systematic Reviews

Research

Nicola Di Girolamo¹  Reint A. Meursinge Reynders²  Pauline A. J. Steegmans³  Shandra Bipat⁴ 

[1]Department of Clinical Sciences, College of Veterinary Medicine, Cornell University, Ithaca, NY, USA

[2]EBMVet, Via Sigismondo Trecchi 20, 26100, Cremona, CR, Italy

[3]Department of Oral and Maxillofacial Surgery, Amsterdam University Medical Center (Amsterdam UMC), Location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands

[4]Studio Di Ortodonzia, Via Matteo Bandello 15, 20123, Milan, Italy

[5]Department of Orthodontics, Academisch Centrum Tandheelkunde Amsterdam (ACTA), University of Amsterdam, Gustav Mahlerlaan 3004, 1081 LA, Amsterdam, The Netherlands

[6]Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center (Amsterdam UMC), Location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands

关键词: Orthodontics;    Reporting;    Systematic review;    Interventions;    Adverse effect;    Adverse event;    Harm;    Safety;    Side effect;    Patient important outcomes;   

DOI  :  10.1186/s13643-023-02273-7

 received in 2022-02-11, accepted in 2023-06-15,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundSystematic reviews that assess the benefits of interventions often do not completely capture all dimensions of the adverse effects. This cross-sectional study (part 1 of 2 studies) assessed whether adverse effects were sought, whether the findings on these effects were reported, and what types of adverse effects were identified in systematic reviews of orthodontic interventions.MethodsSystematic reviews of orthodontic interventions on human patients of any health status, sex, age, and demographics, and socio-economic status, in any type of setting assessing any type of adverse effect scored at any endpoint or timing were eligible. The Cochrane Database of Systematic Reviews and 5 leading orthodontic journals were manually searched for eligible reviews between August 1 2009 and July 31 2021. Study selection and data extraction was conducted by two researchers independently. Prevalence proportions were calculated for four outcomes on seeking and reporting of adverse effects of orthodontic interventions. Univariable logistic regression models were used to determine the association between each one of these outcomes and the journal in which the systematic review was published using the eligible Cochrane reviews as reference.ResultsNinety-eight eligible systematic reviews were identified. 35.7% (35/98) of reviews defined seeking of adverse effects as a research objective, 85.7% (84/98) sought adverse effects, 84.7% (83/98) reported findings related to adverse effects, and 90.8% (89/98) considered or discussed potential adverse effects in the review. Reviews in the journal Orthodontics and Craniofacial Research compared with Cochrane reviews had approximately 7 times the odds (OR 7.20, 95% CI 1.08 to 47.96) to define seeking of adverse effects in the research objectives. Five of the 12 categories of adverse effects accounted for 83.1% (162/195) of all adverse effects sought and reported.ConclusionsAlthough the majority of included reviews sought and reported adverse effects of orthodontic interventions, end-users of these reviews should beware that these findings do not give the complete spectrum on these effects and that they could be jeopardized by the risk of non-systematically assessing and reporting of adverse effects in these reviews and in the primary studies that feed them. Much research is ahead such as developing core outcome sets on adverse effects of interventions for both primary studies and systematic reviews.

【 授权许可】

CC BY   
© The Author(s) 2023

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