Topic outline
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Introduction
Methods writing is as diverse as the range of methods and approaches used in the sciences. But of course the content always provides answers to the same questions:
- what will be or was done
- in what order
- how it will be or was done
- why it was done in this way.
The study design should be brief to enable the reader to quickly understand your study design, without at the same time skipping important detail and explanation. Study design writing in the research proposal is written to provide sufficient detail to enable a trained scientist to evaluate the feasibility of your research design. It is important to provide exact and detailed measures and information, and to provide a justification for choices made.
The study design or overview
The first part of methods writing is the overview. This may also be called the ‘study design’ or ‘experimental design’ section. The overview includes all the key information the reader needs to understand the overall research design. The study aim, the method/s, and other critical information such as the study site or participants, as relevant, should be included in the summary of the study design.
The overview typically appears at the end of the introduction of the research proposal, and in the beginning of the research design section of the research proposal. Most commonly, the overview in the methods or study design section of the proposal will be more detailed than the overview in the introduction of the research proposal. Some overlap can be good for the story line.
Examples of study design overviews in the research proposal introduction, and in the introduction of the study design section of the research proposal are provided below.
Brief overview of the study design in the last paragraph of the research proposal introduction:
Patients with epilepsy diagnosed from ages 0–5 years and 6–20 years old will be compared with matched controls in order to determine differences between patient groups and controls on mortality and morbidity outcomes.
Introductory paragraph of the study design section in the research proposal:
Patient groups with epilepsy will be compared with a randomly selected control group matched for age, gender, and place of residence. Patients will be subdivided into two age groups—epilepsy diagnosis at 0–5 years and 6–20 years of age—in order to distinguish differences for early and late onset childhood and adolescent epilepsy. The two control groups have no diagnosis of epilepsy, but may have other health conditions. The variables to be measured are morbidity and mortality. Patient information will be obtained from the National Patient Registry. Information about control subjects will be obtained from the Civil Registration System.
The main body
In order to write the main body it will be necessary to decide what information needs to be provided, and in what order it should be provided. It can be helpful to observe the kind of content, headings and style of writing adopted in studies that use a similar method or study design to your own. This can assist you in deciding what to include, in what order to include it, and what kinds of justifications and explanation you will need to provide in your research proposal.
Those writing in the health and medical sciences, are likely to find the Equator network (https://www.equator-network.org/) a useful site. The Equator network is an organisation of researchers, medical journal editors, peer reviewers, developers of reporting guidelines, research funding bodies and other collaborators who aim to improve the quality of research publications and research in the health and medical sciences. The website provides a comprehensive collection of online resources providing up-to-date information, tools and other materials related to health research reporting.
Research design writing usually provides more general information first, such as for example information about the site or a model that will be used for calculations. Information is then provided to follow the chronology of the study. Explain what you will do first, what you will do next, and so on, ending with a discussion of how any data produced by an experiment or test will be treated.
Provide the detail necessary to enable your panel to evaluate and constructively discuss your study design.
The other key consideration in writing up the study design is to ensure that the rationale, or the justification for the choices and decisions made in the design, is clear to your reviewers. The justifications researchers offer to support their study design usually link back to the research aim in some way. This because a 'good' research design achieves the study aim.
A worksheet has been provided at the end of this resource to assist you in determining what content needs to be provided for different methods in the study design, as well as typical rationales used for qualitative studies.
Use of language in the study design
The study design section of the research proposal uses 'passive' voice. Rather than name the agent undertaking the action, as for active voice, study design writing explains what will be done without naming the agent.
Active voice: The researcher will calibrate the instrument to ... .
Passive voice: The instrument will be calibrated to ... .
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