Guideline for Manuscript
By ICMJE
Introduction
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Provide a context or background for the study (that is, the nature of the problem
and its significance).
State the specific purpose or research objective of, or hypothesis tested by, the
study or observation.
Cite only directly pertinent references, and do not include data or conclusions
from the work being reported.
Methods
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The guiding principle of the Methods section should be clarity about how and why
a study was done in a particular way.
The Methods section should aim to be sufficiently detailed such that others with
access to the data would be able to reproduce the results.
In general, the section should include only information that was available at the
time the plan or protocol for the study was being written; all information obtained
during the study belongs in the Results section.
If an organization was paid or otherwise contracted to help conduct the research
(examples include data collection and management), then this should be detailed
in the methods.
The Methods section should include a statement indicating that the research was
approved by an independent local, regional or national review body (e.g., ethics
committee, institutional review board). If doubt exists whether the research was
conducted in accordance with the Helsinki Declaration, the authors must explain
the rationale for their approach and demonstrate that the local, regional or
national review body explicitly approved the doubtful aspects of the study.
1) Selection and Description of Participants
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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.
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.
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If the study was done involving an exclusive population, for example in only one
sex, authors should justify why, except in obvious cases, (e.g., prostate cancer).”
Authors should define how they determined race or ethnicity and justify their
relevance.
Authors should use neutral, precise, and respectful language to describe study
participants and avoid the use of terminology that might stigmatize participants.
2) Technical Information
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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.
3) Statistics
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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.
Results
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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.
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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.
Discussion
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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 finings in
the context of the totality of the relevant evidence.
State the 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.
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