Page 56 - Read Online
P. 56
Author Instructions
the rationale for their approach and demonstrate that the local, regional or national review body explicitly approved the
doubtful aspects of the study.
2.3.2.2.1 Selection and Description of Participants
Clearly describe the selection of observational or experimental participants (healthy individuals or patients, including
controls), including eligibility and exclusion criteria and a description of the source population. Because the relevance of
such variables as age, sex, or ethnicity is not always known at the time of study design, researchers should aim for inclusion
of representative populations into all study types and at a minimum provide descriptive data for these and other relevant
demographic variables. Comment on how representative the study sample is of the larger population of interest.
Ensure correct use of the terms sex (when reporting biological factors) and gender (identity, psychosocial or cultural
factors), and, unless inappropriate, report the sex and/or gender of study participants, the sex of animals or cells, and
describe the methods used to determine sex and gender. If the study was done involving an exclusive population, for
example in only one sex, authors should justify why. Authors should define how they determined race or ethnicity and
justify their relevance. In the case where race or ethnicity was not collected, explain why it was not collected. Race and
ethnicity are social and not biological constructs; authors should interpret results associated with race and ethnicity in that
context. Authors should use neutral, precise, and respectful language to describe study participants and avoid the use of
terminology that might stigmatize participants.
2.3.2.2.2 Technical Information
Specify the study’s main and secondary objectives–usually identified as primary and secondary outcomes. Identify methods,
equipment (give the manufacturer’s name and address in parentheses), and procedures in sufficient detail to allow others to
reproduce the results. Give references to established methods, including statistical methods (see below); provide references
and brief descriptions for methods that have been published but are not well-known; describe new or substantially modified
methods, give the reasons for using them, and evaluate their limitations. Identify precisely all drugs and chemicals used,
including generic name(s), dose(s), and route(s) of administration. Identify appropriate scientific names and gene names.
2.3.2.2.3 Statistics
Describe statistical methods with enough detail to enable a knowledgeable reader with access to the original data to judge
its appropriateness for the study and to verify the reported results. When possible, quantify findings and present them
with appropriate indicators of measurement error or uncertainty (such as confidence intervals). Avoid relying solely on
statistical hypothesis testing, such as P values, which fail to convey important information about effect size and precision
of estimates. References for the design of the study and statistical methods should be to standard works when possible (with
pages stated). Define statistical terms, abbreviations, and most symbols. Specify the statistical software package(s) and
versions used. Distinguish prespecified from exploratory analyses, including subgroup analyses.
2.3.2.3 Results
Present your results in logical sequence in the text, tables, and figures, giving the main or most important findings first. Do
not repeat all the data in the tables or figures in the text; emphasize or summarize only the most important observations.
Provide data on all primary and secondary outcomes identified in the Methods Section. Extra or supplementary materials
and technical details can be placed in an appendix where they will be accessible but will not interrupt the flow of the text,
or they can be published solely in the electronic version of the journal.
Give numeric results not only as derivatives (for example, percentages) but also as the absolute numbers from which the
derivatives were calculated. Restrict tables and figures to those needed to explain the argument of the paper and to assess
supporting data. Use graphs as an alternative to tables with many entries; do not duplicate data in graphs and tables. Avoid
nontechnical uses of technical terms in statistics, such as “random” (which implies a randomizing device), “normal,”
“significant,” “correlations,” and “sample.”
Separate reporting of data by demographic variables, such as age and sex, facilitate pooling of data for subgroups across
studies and should be routine, unless there are compelling reasons not to stratify reporting, which should be explained.
2.3.2.4 Discussion
It is useful to begin the discussion by briefly summarizing the main findings, and explore possible mechanisms or
explanations for these findings. Emphasize the new and important aspects of your study and put your findings in the context
of the totality of the relevant evidence. State any limitations of your study, and explore the implications of your findings
for future research and for clinical practice or policy. Discuss the influence or association of variables, such as sex and/or
gender, on your findings, where appropriate, and the limitations of the data. Do not repeat in detail data or other information
given in other parts of the manuscript, such as in the Introduction or the Results section. Link the conclusions with the
goals of the study but avoid unqualified statements and conclusions not adequately supported by the data. In particular,
distinguish between clinical and statistical significance, and avoid making statements on economic benefits and costs
unless the manuscript includes the appropriate economic data and analyses. Avoid claiming priority or alluding to work
that has not been completed. State new hypotheses when warranted, but label them clearly.
2.3.2.5 Conclusion
It should state clearly the main conclusions and include the explanation of their relevance or importance to the field.
Mini-invasive Surgery VII