METRICS-In-Vitro Studies

 

The rationale behind the development of the tool:

APOCP journals receives many manuscripts describing or studying the anti-cancer properties of natural compound for its catchment area especially east and central Asia scientists.  There are unrepresented variations in reporting quality and structure of these manuscripts bringing many uncertainties in the peer review process.  In the light of such a variation, there is a need to develop a consensus-based guideline for an objective quality improvement/assessment for authors as well as reviewers, and editors evaluating these reports and manuscripts.

This tool aims to enable reviewers to critically assess the reproducibility capacity and data quality of a submitted manuscript as part of a full peer review system. In addition, the tool’s items are designed to detect the shortcomings that a manuscript may have in reporting design, conduct, and analyses of a study reporting anti-cancer activities of a natural compounds.  Some major components are listed here, but not exhausted:

  • – One of the most common shortcoming/pitfalls in the in vitro studies is pseudo-replication. In a considerable number of studies assessing natural products’ anticancer activity, only a single cell line taken from one human or animal species is used in triplicate in assay systems. Since these replications are not independent of each other, we should consider this as a kind of pseudo-replication. Therefore, different cell lines or any other forms of biological entities should be used as replication units in such assays.
  • – Some items of this tool have been proposed to assist the peer reviewers in appraising the study’s internal validity. Internal validity is defined as the extent to which the work eliminates the possibility of biases. Primary known sources of biases that may confound in vivo studies include selection bias, performance bias, detection bias, and attrition bias. However, the mitigating tactics against the above-mentioned sources of bias are not taken by researchers as much as they should be in the in vitro studies. Therefore, the items of this tool have addressed major principles preventing experimental biases.
  • – To establish a high level of confidence that the data of submitted manuscripts are reliable, the authentication and mycoplasma testing of the in vitro model system is critical. This issue has been addressed in this tool.
  • – To ensure the replicability of an in vitro study by other researchers and to verify the reproducibility of findings, explanation of a minimum of information that clearly and transparently defines all experimental reagents, procedures, data processing, and findings, is necessary (to ensure that the complete experiment is described with a high degree of reproducibility).
  • – One important aspect that have been tried to be touched in this tool is the natural product’s characterization. Natural products contain a diverse range of organic molecules. The type and amount of these components may vary greatly based on the time and geographical location in which the products are harvested and processing conditions. Therefore, the peer reviewer should ensure that the researcher has reported the natural product’s characteristics as much as the test agents in detail.
  • The first draft of the tool was developed based on a comprehensive review of available relevant quality assessment tools/checklists and several rounds of onsite and online meetings/brain storming of the core committee members.

The tool has been organized to help the peer-review process of structured manuscripts reporting natural products’ in vitro anticancer activity. The tool is organized based on the major sections of a scientific manuscript (Introduction, Material and Methods, Results, Discussion, and Technical/Acknowledgments).  Each section is broken down into different items (an item measures if a manuscript addresses concerns that must be reported in that section).  For each section, several items have been extracted by the core committee after a comprehensive review of available relevant quality assessment tools.

Definitions used in the development of the tool:

A natural product is defined here as any whole or part of a plant (including plant exudates), animal or microorganism that is unprocessed (raw material) or that has been processed, pulverized or extracted. This class does not include any individual substance derived from plants/animals or other organisms with specific pharmacologic activity. We define in vitro technics as methods to study a product’s effect in an artificial environment outside a living organism, including cell lines, organoids/tumoroids, or patient-derived tissues. We also define anticancer activity as the inhibitory or preventive effects of products on neoplasms’ proliferation. 

Title:  Development of a Critical Appraisal Tool for the Peer-Review of In Vitro Studies Assessing the Anticancer Activity of Natural Products.

Rational: APJCP receives many manuscripts describing or studying the anti-cancer properties of natural compound for its catchment area especially east and central Asia scientists.  There are unrepresented variations in reporting quality and structure of these manuscripts bringing many uncertainties in the peer review process.  In the light of such a variation, there is a need to develop a consensus-based guideline for an objective quality improvement/assessment for authors as well as reviewers, and editors evaluating these reports and manuscripts.

Specific objectives:

  • To develop, validate and publish a valid, reliable, and consensus-based guideline for authors reporting research evaluating anti-cancer activities of natural compounds.
  • To provide an objective tool to evaluate manuscripts reporting anti-cancer activities of natural compounds for reviewers and editors evaluating these reports.

Methodology:

The road map to develop this tool (as a quality assessment instrument for reviewers and a quality improvement guideline for authors) includes six steps. A core working committee will develop an initial draft and a scientific committee consisting of editors and scientists the field of natural compound and in-vitro studies will comment, evaluate, and improve the initial draft. The whole process of the development is consisted of 6 steps (detailed below). The core working committee involved in providing the first draft, managing scientific committee’s consensus and finalizing the guideline. The scientific committee members are directly involved in steps 2, 3 and 6 and indirectly in the whole development process. In addition, three independent reviewers/editors are involved in step 5 (evaluating the reliability of the tool). The details of all steps are listed as follows:

  • Step one: A core working committee of four experts will develop the first draft of the guideline going through the following steps:
    1. Comprehensive review of available relevant quality assessment tools, (both generic and specific)
    2. Extracting important and relevant items from these tools and adapting these items in order to develop the guideline’s specific items.
    3. Developing new specific items which may not be covered by previous tools.
    4. Holding several rounds of Delphi and online meetings to finalize the first draft of the tool, based on the selected items of steps b and c
  • Step two: After developing the first draft, we will form a “scientific committee” including at least 10 editorial experts from different countries, various journals and international societies. The core working committee will collaborate with scientific committee members to obtain their comments and rsuggestion for draft item using a pre-define electronic form which aims to:
    1. Assessing the current items of the first draft of this tool, regarding some criteria such as necessity and applicability.
    2. Suggest any correction or revision to current items
    3. Suggest any new items to be added to the first draft
  • Step Three: After collecting the scientific committee comments on the draft, the core working committee will provide a first final draft to be presented in an online meeting with all scientific and core working committee members to discuss on this version after a mini-workshop (to describe the consensus procedure). At the end of the meeting, all final corrections will be made and the semi-final version will be approved via the consensus of meeting members to be used in further surveys.
  • Step Four: We will conduct an online survey of at least 50 reviewers on the semi-final version of this tool, to assess the face and content validity of the tool via a quantitative rating of each item (based on importance, clarity, etc) and a written comments and opinion if available. All questionnaires will be collected and summarized by analysis software along with qualitative content analysis of open written comments. Considering the results of this step, this tool will be revised again by the core working committee and a new revised tool will be developed.
  • Step Five: In this step, we will conduct another online survey including 30 previously accepted and 30 rejected manuscripts (preferably from other journals rather than APJCP). All these papers will be assessed by three independent reviewers using our new revised tool. The data will be analyzed to calculate inter-observer reliability. If any item could not obtain enough reliability score, it will be revised or removed by a consensus between these three reviewers and core working committee members.
  • Step Six: The final suggestions to finally revise this tool will be provided to prepare the final version of this tool. Inviting scientific committee members, another online meeting will be held and all final changes are presented in this meeting. At the end of this meeting, the final tool will be approved by all members of both committees (core working and scientific). The final tool, along with the results of this multi-phase study will be published by authorship of all both committee members and three independent reviewers.

The Core working group team:

Lead Contributor:

  • Sammad MohammadNejad, MD Ph.D. (Cancer Resarch center, Cancer Institute, Tehran university of Medical Sxcienbces, Tehran.n

Committee members: 

  • Jalal Pourahmad, Ph.D. Professor of Toxicology, Department of Toxicology and Pharmacology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
  • Alireza Mosavi Jarrahi, MSPH, Ph.D. Associate Prof. of Epidemiology, Dept of Social Medicine, Medical School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Interim Scientific Committee Members:

  • Muhammad Asif Qureshi, Ph.D., Tumor Immunology, Department of Pathology, Dow International Medical College, Dow University of Health Sciences (OJHA CAMPUS), Karachi, Pakistan.
  •  Shahab Uddin, Ph.D., Translational Research Institute, Academic Health System, Hamad Medical Corporation, Doha, Qatar 
  • Ajaz Ahmad Bhat, Ph.D., Cancer Biology, Interim Translational Research Institute, Academic Health System, Hamad Medical Corporation, Doha, Qatar.
  • Pratheeshkumar Poyil, Ph.D., Biotechnology, Associate Scientist, King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia.
  • Mukhtiar Baig, Ph.D. Clinical Biochemistry/Medical Educationist, King Abdulaziz University, Jeddah, Saudi Arabia.
  • Jalal Pourahmad, Ph.D. Professor of Toxicology, Department of Toxicology and Pharmacology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
  • Trivadi Ganesan, Ph.D., Professor Medical Oncology and Clinical Research, Cancer Institute (WIA), Chennai, India.
  • Abdul Quaiyoom Khan, Ph.D., Molecular Carcinogenesis and Chemoprevention Division, Department of Medical Elementology and Toxicology, Faculty of Science, Jamia Hamdard (Hamdard University), Hamdard Nagar, New Delhi, India.
  • Zainab Siddiqui,Ph.D., Senior Research Analyst, Department of Pathology, Era’s Lucknow Medical College & Hospital, India
  • Maha El-Demellawy, Ph.D., Genetic Engineering, Biotechnology Research Institute (GEBRI)-SRAT-city, Egypt.
  • Constance Lay Lay Saw, Ph.D., Pharmaceutical Sciences,  Center for Cancer, Prevention Research, Department of Pharmaceutics, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, USA 
  • Dewajani Purnomosari, Ph.D., Department of Histology and Cell Biology. Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.
  • Dr. Faridon Kavosi, Research Center for Non-communicable Diseases, Jahrom University of Medical Sciences, Jahrom, Iran
  • Dr. Elsayed I Salim, Ph.D., Faculty of Science, Tanta University, Tanta, Egypt, Egypt.

Research Associate:

  • Rahil Mosavi Jarrahi, The University of Sheffield, UK

Research Assistants:

  • Zahra Mousavi Jarrahi, Shahrood University of Medical Sciences, Iran
  • Hoda Golmahi, West Asia Organization for Cancer Prevention (APOCP’s West Asia Chapter.).

You can read the statement of the guideline “Development of a Critical Appraisal Tool (AIMRDA) for the Peer-Review of Studies Assessing the Anticancer Activity of Natural Products: A Step towards Reproducibility“

You can comment the guideline by sending an email to “Guideline.waocp@gmail.com”

The appraisal tool, developed based on this guideline can be downloaded at: AIMRDA-Standard-Reporting-for-Anticancer Activity of Natural-Componds-Tool

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