RoBDEMAT: A risk of bias tool and guideline to support reporting of pre-clinical dental materials research and assessment of systematic reviews

被引：62

作者：

Delgado, Antonio H. S. ^{[1
,2
]}

Sauro, Salvatore ^{[3
]}

Lima, Adriano F. ^{[4
]}

Loguercio, Alessandro D. ^{[5
]}

Della Bona, Alvaro ^{[6
]}

Mazzoni, Annalisa ^{[7
]}

Collares, Fabricio Mezzomo ^{[8
]}

Staxrud, Frode ^{[9
]}

Ferracane, Jack ^{[10
]}

Tsoi, James ^{[11
]}

Amato, Julia ^{[12
]}

Neuhaus, Klaus W. ^{[12
,13
]}

Ceballos, Laura ^{[14
]}

Breschi, Lorenzo ^{[7
]}

Hannig, Matthias ^{[15
]}

Melo, Mary Anne ^{[16
]}

Ozcan, Mutlu ^{[17
]}

Scotti, Nicola ^{[18
]}

Opdam, Niek ^{[19
]}

Yamaguchi, Satoshi ^{[20
]}

Paris, Sebastian ^{[21
]}

Turkun, Lezize Sebnem ^{[22
]}

Domejean, Sophie ^{[23
,24
,25
]}

Rosa, Vinicius ^{[26
,27
]}

Palin, William ^{[28
]}

Schwendicke, Falk ^{[29
]}

机构：

[1] Ctr Invest Interdisciplinar Egas Moniz CiiEM, P-2829511 Monte De Caparica, Almada, Portugal

[2] UCL Eastman Dent Inst, Dept Biomat & Tissue Engn, London, England

[3] CEU Univ, Cardenal Herrera CEU Univ, Dept Dent, Dent Biomat & Minimally Invas Dent, Valencia, Spain

[4] Univ Paulista, Dent Res Div, Sao Paulo, Brazil

[5] Univ Estadual Ponta Grossa, Sch Dent, Dept Restorat Dent, Ponta Grossa, Parana, Brazil

[6] Univ Passo Fundo, Sch Dent, Postgrad Program Dent, Passo Fundo, RS, Brazil

[7] Univ Bologna, Dept Biomed & Neuromotor Sci DIBINEM, Alma Mater Studiorum, Bologna, Italy

[8] Univ Fed Rio Grande do Sul, Dept Dent Mat, Porto Alegre, RS, Brazil

[9] Nord Inst Dent Mat NIOM, Oslo, Norway

[10] Oregon Hlth & Sci Univ, Dept Restorat Dent, 2730 S Moody Ave, Portland, OR 97201 USA

[11] Univ Hong Kong, Fac Dent, Dent Mat Sci Appl Oral Sci & Community Dent Care, Hong Kong, Peoples R China

[12] Univ Basel, Univ Ctr Dent Med Basel UZB, Dept Periodontol Endodontol & Cariol, Basel, Switzerland

[13] Univ Bern, Bern Univ Hosp, Dept Dermatol, Inselspital, Bern, Switzerland

[14] Rey Juan Carlos Univ, Hlth Sci Fac, Nursing & Stomatol Dept, Madrid, Spain

[15] Saarland Univ, Clin Operat Dent Periodontol & Prevent Dent, D-66421 Homburg, Germany

[16] Univ Maryland, Dept Gen Dent, Div Operat Dent, Sch Dent, 650 West Baltimore St, Baltimore, MD 21201 USA

[17] Univ Zurich, Ctr Oral Med, Div Dent Biomat, Clin Reconstruct Dent, Zurich, Switzerland

[18] Univ Turin, Dent Sch Lingotto, Dept Surg Sci, Turin, Italy

[19] Radboud Univ Nijmegen Med Ctr, Dept Dent, Radboud Inst Hlth Sci, Nijmegen, Netherlands

[20] Osaka Univ, Grad Sch Dent, Dept Biomat Sci, Suita, Osaka 5650871, Japan

[21] Charite Univ Med Berlin, Ctr Oral Hlth Sci, Dept Operat Prevent & Paediat Dent, Berlin, Germany

[22] Ege Univ, Sch Dent, Dept Restorat Dent, TR-35100 Bornova, Turkey

[23] CHU Estaing, Serv Odontol, Clermont Ferrand, France

[24] Univ Clermont Auvergne, UFR Odontol, Clermont Ferrand, France

[25] Ctr Rech Odontol Clin, EA 4847, Clermont Ferrand, France

[26] Natl Univ Singapore, Fac Dent, Singapore, Singapore

[27] Natl Univ Singapore, ORCHIDS Oral Care Hlth Innovat & Designs Singapor, Singapore, Singapore

[28] Univ Birmingham, Coll Med & Dent Sci, Sch Dent, Dent & Biomat Sci, Birmingham, W Midlands, England

[29] Charite Univ Med Berlin, Dept Operat & Prevent Dent, Assmannshauser Str 4-6, D-14199 Berlin, Germany

来源：

JOURNAL OF DENTISTRY | 2022年 / 127卷

关键词：

Bias; Biomedical and dental materials; Dental materials; In vitro techniques; Laboratory studies; Risk assessment; Systematic review; BOND STRENGTH; TESTS; METAANALYSES; PERFORMANCE;

D O I：

10.1016/j.jdent.2022.104350

中图分类号：

R78 [口腔科学];

学科分类号：

1003 ;

摘要：

Objectives: To develop a risk of bias tool for pre-clinical dental materials research studies that aims to support reporting of future investigations and improve assessment in systematic reviews. Methods: A four-stage process following EQUATOR network recommendations was followed, which included project launch, literature review, Delphi process and the tool finalization. With the support of the European Federation of Conservative Dentistry (EFCD) and the Dental Materials Group of the International Association for Dental Research (DMG-IADR), a total of 26 expert stakeholders were included in the development and Delphi vote of the initial proposal. The proposal was built using data gathered from the literature review stage. During this stage, recent systematic reviews featuring dental materials research, and risk of bias tools found in the literature were comprehensively scanned for bias sources. The experts thus reached a consensus for the items, domains and judgement related to the tool, allowing a detailed guide for each item and corresponding signalling questions.Results: The tool features nine items in total, spread between 4 domains, pertaining to the following types of bias: bias related to planning and allocation (D1), specimen preparation (D2), outcome assessment (D3) and data treatment and outcome reporting (D4). RoBDEMAT, as presented, features signalling questions and a guide that can be used for RoB judgement. Its use as a checklist is preferred over a final summary score.Conclusion: RoBDEMAT is the first risk of bias tool for pre-clinical dental materials research, supported and developed by a broad group of expert stakeholders in the field, validating its future use.Clinical significance: This new tool will contribute the study field by improving the scientific quality and rigour of dental materials research studies and their systematic reviews. Such studies are the foundation and support of future clinical research and evidence-based decisions.

引用

页数：9

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