Department of Preventive and Pediatric Dentistry, Greifswald University Dental Clinics, Walther-Rathenau-Straße 42a, 17475, Greifswald, Germany.
Department for Periodontology, Preventive and Restorative Dentistry, Center for Dental and Oral Medicine, University Medical Center Hamburg-Eppendorf (UKE), Martinistraße 52, 20246, Hamburg, Germany.
Eur Arch Paediatr Dent. 2024 Feb;25(1):65-73. doi: 10.1007/s40368-023-00854-7. Epub 2023 Nov 26.
The significance of the underlying literature in clinical guidelines can be weakened by the risk of bias, which could negatively affect the recommendations. Especially in controversial matters, such as fluoride use for caries prevention in children, biased results may be not reliable and lead to incorrect conclusions. This study was performed to detect bias in underlying literature of the German guideline for caries prevention using fluoride in children, where no consensus was reached between paediatricians and paediatric dentists.
Three tools used for risk of bias assessments of different study designs were RoB 2 for RCTs, ROBINS-I for non-randomized studies, and ROBIS for systematic reviews. For each study cited in the guideline two independent risk of bias assessments were performed. Disagreements were resolved by consensus.
Out of 58 papers, 48.3% (n = 28) showed high risk of bias, with the majority in sections regarding fluoride tablets, fluoridated toothpaste, and paediatricians' recommendations. 9 out of 20 recommendations and statements were based on studies with high risk of bias, all of which were in these three controversial sections. 13 out of 29 RCTs showed high risk of bias (44.8%), as all 13 non-randomized trials did, while only 2 of 16 (12.5%) systematic reviews had high risk of bias.
Considering risk of bias of cited studies in clinical guidelines may result in substantial changes in its recommendations and aid in reaching consensus. Efforts should be made to assess risk of bias of underlying literature in future clinical guidelines.
临床指南中基础文献的意义可能因偏倚风险而减弱，这可能会对建议产生负面影响。特别是在氟化物用于儿童龋齿预防等有争议的问题上，有偏倚的结果可能不可靠，并导致错误的结论。本研究旨在检测德国儿童氟化物防龋指南中基础文献的偏倚，该指南中儿科医生和儿童牙医之间未达成共识。
使用三种工具评估不同研究设计的偏倚风险，RCT 采用 RoB 2，非随机研究采用 ROBINS-I，系统评价采用 ROBIS。对指南中引用的每一篇论文进行两次独立的偏倚风险评估。意见分歧通过共识解决。
在 58 篇论文中，48.3%（n=28）显示出高度偏倚风险，其中大部分在涉及氟化物片剂、含氟牙膏和儿科医生建议的章节中。20 条建议和陈述中有 9 条基于高偏倚风险的研究，所有这些研究都在这三个有争议的章节中。29 项 RCT 中有 13 项（44.8%）显示出高度偏倚风险，所有 13 项非随机试验均如此，而只有 16 项系统评价中的 2 项（12.5%）显示出高度偏倚风险。
考虑临床指南中引用研究的偏倚风险可能会导致其建议发生重大变化，并有助于达成共识。未来的临床指南应努力评估基础文献的偏倚风险。
