|Year : 2022 | Volume
| Issue : 4 | Page : 984-989
Evidence, ethics, and quality appraisal tool for In Vitro studies: A concept note based on scoping review of current tools relevant to dental In Vitro research
Ramya R Iyer1, Rajesh Sethuraman2
1 Department of Public Health Dentistry, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth (An Institution Deemed to be University), Vadodara, Gujarat, India
2 Department of Prosthodontics, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth (An Institution Deemed to be University), Vadodara, Gujarat, India
|Date of Submission||26-Aug-2022|
|Date of Acceptance||07-Oct-2022|
|Date of Web Publication||10-Feb-2023|
Dr. Ramya R Iyer
Department of Public Health Dentistry, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth (An Institution Deemed to be University), Piparia, Waghodia, Vadodara - 391 760, Gujarat
Source of Support: None, Conflict of Interest: None
The contribution of in vitro studies has been often under-valued in the context of dental research quality owing to the in vitro study's position in the bottom of the evidence pyramid and the limited number of appraisal tools which are comprehensive. There is a need to understand the scope and shortcomings of current tools used in the appraisal of in vitro studies as applicable to dental research and to propose a new quality appraisal tool for in vitro research which is superior to the current tools. A scoping review was conducted to address the above- mentioned objectives; a systematic search in the PubMed and Google databases was done for pertinent published articles as available till September 14, 2021. Concept notes, protocols, and editorials that reported tools for critical appraisal of in vitro studies in dentistry for both primary and secondary researches. After screening of titles, abstracts and after eliminating duplicates, two tools were found that met the inclusion and exclusion criteria of the present scoping review. Critical appraisal of the two tools – modified CONSORT checklist of items for reporting in vitro studies of dental materials and CRIS (Check- list for Reporting In- vitro Studies) had limitations with respect to relevance, ethical considerations, and applicability. Based on the inadequacies identified in the existing appraisal tools, a preliminary checklist – Evidence, Ethics, and Quality Appraisal Tool for in vitro studies is proposed as a new tool that integrates quality appraisal of experimental procedures along with ethical standards, relevant to dental in vitro research.
Keywords: Critical appraisal tools, dental research, in vitro studies
|How to cite this article:|
Iyer RR, Sethuraman R. Evidence, ethics, and quality appraisal tool for In Vitro studies: A concept note based on scoping review of current tools relevant to dental In Vitro research. J Datta Meghe Inst Med Sci Univ 2022;17:984-9
| Introduction|| |
Preclinical and laboratory studies are underrated in oral health research owing to not having direct clinical implications. It is a fact that such studies are placed at the bottom of the evidence pyramid; however, these studies, although may not be the sources of best evidence, definitely form the first line of evidence.
In dental sciences research, laboratory studies are not typically “bench studies”. In vitro studies refer to those experimental designs with due consideration to biology/tissue/organism as a whole – in structure and function – whereas the interventions are done outside of the organism. The biological consideration in the in vitro study separates it apart from any other laboratory study done for the mere purpose of a chemical compositional analysis, or physical properties studied in nonhealth science researches. Furthermore, in vitro study models in biomedical science have evolved tremendously. Simulation of the clinical or biological environment has been an encouraging trend in the in vitro experimental methodology.
In vitro studies in material sciences in the field of dentistry have revolutionized the research and development sector. The laboratory-tested materials are tested subsequently through in vivo designs. However, for the contributions of the in vitro studies, translation for patient use could not have been speedier and productive. Therefore, in vitro studies have been the stepping stones to advancements in dental practice.
To understand, how significantly, an in vitro study contributes to the scientific literature and practice, it is imperative to ascertain the quality of such research. Evidence-based appraisal of in vitro study is essential to not only establish the research quality but also to put the in vitro design in the right perspective in the broader context of evidence-based dentistry.
The authors propose a new evidence-based critical appraisal tool (CAT) for in vitro dental studies based on
- Recognizing the components and criteria of the various currently available CATs for in vitro studies in dental sciences
- Lacunae in currently used CATs for in vitro studies applicable to medical and dental sciences.
| Methods|| |
A scoping review of currently available tools for quality assessment of in vitro studies was conducted with the following inclusion and exclusion criteria.
The authors included tools currently available in the public domain for critical appraisal of in vitro studies in dentistry, which included tools developed and disseminated vide independent scientific publications of any article type, namely – concept note, protocol, editorial, etc., All tools that were considered in primary research and secondary research were included in the present review.
Studies pertaining to in vitro models in animal research were excluded. Articles published in languages other than English or where translated versions of such articles were unavailable were excluded.
The search was done on PubMed and Google Scholar databases for the above said inclusion criteria, to retrieve the results as of September 14, 2021. The search terms were: Quality Assessment Tools (OR) Critical Appraisal Tools OR CAT AND in vitro Studies AND Dentistry.
| Results|| |
Based on inclusion criteria and applying the search terms, two tools were retrieved – modiﬁed CONSORT checklist of items for reporting in vitro studies of dental materials and CRIS. The components of the two tools are presented in [Table 1].
|Table 1: Components of modi.ed CONSORT checklist of items for reporting in vitro studies of dental materials and CRIS|
Click here to view
On critical appraisal of these tools, the following gaps were noted:
- Both the modified CONSORT checklist and CRIS checklists, although exhaustive, did not take into consideration disinfection standards and preprocedural preparations of samples as applicable to in vitro studies in dentistry
- The modified CONSORT checklist and CRIS checklist used for in vitro studies have certain items which cannot be directly translated to in vitro models. For example, In the CRIS checklist, the item under “Results” – “Samples lost due to handling process not available for analysis” may not be adopted as an equivalent for “Loss to Follow-up” in randomized controlled studies. It is because, wastage during processing for samples can be compensated by the preparation of new samples, which may not be applicable to randomized controlled trials
- Both the checklists lacked the component of “Ethical Considerations.”
Hence, the need for a new checklist is realized. The authors propose an evidence, ethics, and quality appraisal tool (EEQAT) for in vitro studies as a new tool [Table 2].
|Table 2: Evidence, ethics, and quality appraisal tool for in vitro studies (Copyrighted)|
Click here to view
| Discussion|| |
Assessment of the quality of research is pivotal to evidence generation. Before the publication of a scientific study, the peer review team needs to objectively gauge the worth of the work that can be a potential resource in terms of adding to existing knowledge or translation to practice. Various guidelines and checklists for reporting clinical as well as epidemiological studies have been valuable in providing a transparent and objective mechanism for measuring the quality of research. However, no universally accepted, structured, and standard criteria for quality assessment, specific to in vitro studies in dentistry are available.
Even as most journals have stepped up reporting standards for various research designs, reporting guidelines checklist is not applicable (NA) for in vitro studies. If the uploading checklist is a mandatory field in the journal submission portal, the author is advised to merely prepare a document mentioning NA in the file and upload the same.
Therefore, the quality of in vitro studies is not scrutinized stringently. Furthermore, even after the in vitro research has been published, readers are not able to appraise it adequately as there is a dearth of CAT for in vitro studies. Even internationally recognized and endorsed organizations such as the (CEBM) centre of evidence based medicine do not have prescribed CAT for in vitro studies.
The scoping review hence could retrieve only two existing tools, namely, the modiﬁed CONSORT checklist of items for reporting in vitro studies of dental materials and CRIS.
Checklists as quality appraisal tools have been widely accepted. Several checklists have been developed for reporting scientific studies.
Even in preclinical animal studies, reporting of randomization, blinding, and sample size estimation significantly improved when comparing nature to cell from 2013 to 2015, likely due to the implementation of a checklist. Specifically, improvement in reporting of the three methodological information was at least three times greater when a mandatory checklist was implemented than when it was not.
None of the checklists used in dentistry include an ethical statement as an item/subitem; however, guidance for in vitro studies and methodologies, relevant to experimental pharmacology has included the necessity of ethical statement in the good reporting standards for nonclinical pharmacology and biomedicine. In similar lines, it is important in the context of dental in vitro studies as well to have ethical statements specifying permissions for any materials derived from human volunteers, including appropriate privacy.
| Conclusion|| |
The EEQAT has been proposed envisaging the abovementioned concept to integrate quality appraisal of experimental procedures involved with ethical standards, relevant to dental in vitro research. The preliminary checklist has been copyrighted, which will be subject to further validation and analysis by dental research and evidence-based dentistry peer group for introduction as a universally valid and acceptable tool.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Haidich AB. Meta-analysis in medical research. Hippokratia 2010;14:29-37.
Faggion CM Jr. Guidelines for reporting pre-clinical in vitro
studies on dental materials. J Evid Based Dent Pract 2012;12:182-9.
Krithikadatta J, Gopikrishna V, Datta M. CRIS guidelines (Checklist for Reporting In-vitro
Studies): A concept note on the need for standardized guidelines for improving quality and transparency in reporting in-vitro
studies in experimental dental research. J Conserv Dent 2014;17:301-4.
] [Full text]
Emmerich CH, Harris CM. Minimum Information and Quality Standards for Conducting, Reporting, and Organizing In Vitro
Research. In: Bespalov A, Michel MC, Steckler T, editors. Good Research Practice in Non-Clinical Pharmacology and Biomedicine. Handbook of Experimental Pharmacology. Springer Open: Company Springer Nature Switzerland AG; 2020. p. 189. Available from URL: https://doi.org/100.1007/978-3-030-33656-1
. [Last accessed on 2022 Jul 20th
Samuel GO, Hoffmann S, Wright RA, Lalu MM, Patlewicz G, Becker RA, et al
. Guidance on assessing the methodological and reporting quality of toxicologically relevant studies: A scoping review. Environ Int 2016;92-93:630-46.
[Table 1], [Table 2]