Additional research outcomes

Indicators characterizing additional results (secondary endpoints) of the research that allow, for example, the analysis of other effects or mechanisms of medical intervention should be described.

Subgroup analysis

Subgroup analysis is conducted when it is necessary to evaluate the effects of a medical intervention, or the influence of other factors in various subgroups formed on the basis of sex, age, and clinical and other characteristics.

Methods for registration of outcomes

In this part all the methods and instruments used for recording of the main and additional research outcomes should be described.

Ethical review

Author(s) should provide the information on the verification protocol results by Ethical Committee of any level by a) citing its resolution in this section, b) specifying the document’s ID, c) indicating the date of its signing, and d) citing the official name of the Ethics Committee.

Statistical analysis

The principles of samples size calculating: It means description of samples size calculation procedure. In case of absence of such procedure it should be stated that the samples size was not calculated previously.

Statistical data analysis methods: author(s) should mention the statistical software package used in our research; the form of quantitative data presentation and describe statistical criteria used in our analysis.

Results

Research sample (participants/respondents)

In the section the detailed description of the studied sample (including the presentation of the research scheme, the description of the initial characteristics of research participants) should be provided. For the retrospective studies data sources (medical records, databases, etc.) become the objects of a study.

Primary findings

Author(s) should describe the main result of the study and the associated results of the statistical data analysis. Illustrative reporting (tables, figures) is encouraged but the duplication of data in tables and figures is not allowed.

Additional findings

The subsection describes additional results of the study, results of the evaluation of effects in subgroups and (or) mechanisms of the described effects. The analysis should be limited to only those subgroups listed in the " Subgroup analysis".

Undesirable phenomena

In this part all the undesirable phenomena occurring during the medical procedure should be described. Undesirable phenomena include any medical events (diseases, injuries, unplanned surgical interventions, etc.) whose connection with the medical intervention (preventative, diagnostic, therapeutic or any other) cannot be ruled out. The absence of such phenomena should also be mentioned.

Discussion

All the pro and contras of the research should be discussed in this section.

Summary of the primary research results

Author(s) should present the short summary of the primary research results (min – 3, max – 5 sentences) without duplicating the section “Results”.

Discussion of the primary research results

A discussion of the results related to the hypothesis (the main objective) of the research should be carried out, in the context of previously known data, opinions and theories, including additional research results and subgroup analysis results. If necessary, authors should discuss the key mechanisms of the implementation of the medical intervention effects.

Research limitations

The section should provide analysis of the factors which could significantly affect the study. Such limitations can be assigned to each phase of the study.

Conclusion

In this part we should summarize our results shortly (in 1-3 sentences) without duplicating the “Discussion” part, identify key unsolved aspects of the challenge (in 1-3 sentences as well) and describe the role of our own results in the solving of the challenge (in 5-7 sentences). Conclusion should be a text, not a list of results.

Additional information

Source of funding. The source(s) of funding (it could be a grant) should be indicated specifying with the following statement: “The research was conducted with the financial support of … ”. If the research had no financial funding the section should be left blank.

Conflict of interests. The section indicates the presence of explicit and potential conflicts of interests, i.e. the facts and conditions that may affect results of the study or their interpretation. In case of conflict of interest’s absence it is recommended to use the following phrase: “Authors declare no explicit and potential conflicts of interests associated with the publication of this article”.

Authors involvement. The role of each author in the current study and article preparation should be described in this section.

Acknowledgements. This part provides an opportunity to express the gratitude to those people who took part in the research and/or manuscript preparation but are not co-authors of the paper.

References

The list of references should include only published materials (Internet links are allowed as well). Self-citation should be avoided except those cases which require it (if there are no other sources of information, or the present work is based on the previous studies of your own). The limit is no more than 3 self-citations.

⇐ Предыдущая123

Поделиться: