Journal of Clinical Epidemiology 66 (2013) 817

WRITING TIPS SERIES

Effective writing and publishing scientific papers, part IV: methods

1. What you should know exclusion criteria were applied. Provide a sample size calcula-
tion for studies set up to statistically test a specific hypothesis.
If you consider a research study as a delicate dish of With regard to the data collection, define precisely what
knowledge, a paper’s methods section would be like a recipe exposure (e.g., stressful life events) or intervention (e.g.,
that lists all the necessary ingredients of the study and how cognitive behavioral therapy) you investigated, what out-
they need to be combined during cooking. Ideally, it allows comes you measured (e.g., depression), how you measured
the dish to be prepared again with the same result. The them (e.g., using a self-reported depression scale), and
methods section ties the introduction to the results section when measurements were made (e.g., during the screening
to create a clear story line; it should present the obvious ap- visit and after 12 months of follow-up). Cite original re-
proach to answer the research question and define the struc- search on existing measurement tools you used, and state
ture in which the results will be presented later. if you designed a tool specifically for the study. Provide de-
The methods section of a paper presenting original re- tails of measurement properties (reproducibility, validity,
search from a quantitative study has four basic elements: and responsiveness) if these are crucial for the interpreta-
study design, setting and subjects, data collection, and data tion of the main results. A useful order if you used various
analysis. It is quite common to use such subheadings to measurements is to start with the outcome measure (or de-
structure the section (the target journal may offer specific pendent variable), followed by the exposure measures (or
guidance). In the case of research in humans, the authority main independent variables), and possible covariates.
providing ethical clearance needs to be stated as well. Match the part on data analysis with the research ques-
tions. If you present a primary research question in your
introduction and one or more secondary questions, start
2. What you should do by explaining the primary analysis, followed by the sec-
Start by developing a ‘‘skeleton’’ with the basic elements ondary analyses. Provide sufficient detail on the statisti-
of the methods section (see the first installment of this series). cal techniques you used; do not assume that readers
If available, refer to a published protocol or previously pub- understand what you did from the name of a technique.
lished papers from the same research project for additional Be very clear about the definition and operationalization
information about the methods. This allows you to keep the of the dependent and main independent variable, the use
methods section more concise. Be sure, however, to include of covariates (i.e., if and how you adjusted your analy-
all information that the reader needs to understand on how ses), and the handling of missing data. Be honest and
the key findings in this paper were derived. clear about the analyses you intended a priori to test your
Mention the design of the present study, such as random- hypothesis and the analyses that were exploratory. Avoid
ized controlled trial, prospective/retrospective cohort study, putting results in the methods section, such as numbers of
caseecontrol study, or cross-sectional survey. If you find it subjects recruited and followed up.
difficult to fit your study into a specific type of design, try to As there may be various ways to answer a research ques-
describe the key design components, for example whether it tion, try to explain, where necessary, why you made certain
was an interventional and/or observational study and whether methodological choices and why you think these were the
data were collected longitudinally and/or cross-sectionally. best options given the context. You can demonstrate the
Explain when and where the study was conducted, how the credibility of your methods by citing previous research.
sample was recruited or selected, and which inclusion/ After you have drafted the methods section, ask your-
self, ‘‘Would a researcher be able to reproduce our study
with the information I provide in this paper?’’ Also check
Checklist for the methods section whether the section contains redundant information that is
 Include basic information on study design, setting and subjects, not necessary to understand the paper’s story line. This
data collection, data analysis, and ethical approval check is particularly important when the paper is one of
 Refer to previous publications from the same large research project, the many arising from a larger study. Only describe
such as a study protocol, for additional information (if applicable) methods for which results are presented later.
 Consider providing detailed information on the methods as web-
only supplementary materials
 Ask yourself, ‘‘Would a researcher be able to reproduce the study Daniel Kotz and Jochen W.L. Cals
with the information I provide in this paper?’’ E-mail address: [email protected] (D. Kotz)
0895-4356/$ - see front matter Ó 2013 Elsevier Inc. All rights reserved.
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