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This webpage explains why you need a study protocol and what it should include. You will also find examples that you can download and modify to get a kick-start on your own study protocol.
You will understand this webpage best if you first read the page Introduction to research.
A project involves an extra effort during a limited time. After the project is over we want to know if what you did was so good that it should be incorporated in the routine of our health care, school management, business (or whatever). If the answer is yes it might result in funding taken away from another part of the organisation to give priority to your suggested new routines. Different ideas for improvement of the organisation will be evaluated against each other. In order to make these decisions each suggestion for improvement need to be properly evaluated.
The most important part of planning for an evaluation of a project takes place way before data collection. This webpage describes what needs to be in the written presentation of a project before data is collected. (Writing a manuscript after data is collected and analyzed is described in another webpage.)
The written presentation of your planned project has many names such as; study protocol, project plan, clinical investigation plan (CIP), clinical trial protocol. Study protocol is the most common name.
Why a study protocol?
There are two main reasons to write a carefully planned study protocol:
- For you as a project manager.
A project can be viewed upon as the construction plan when you are building a house. There are those who manage to build a complete house from scratch without any construction plan. However, it is not recommended. In almost every project new interesting questions appear along the way. When this happens it is useful to have a look at the construction plan and read what you have written there. It must be very strong reasons to change the construction plan after the building process has commenced. New interesting ideas appearing along the way is not uninteresting. On the contrary! They can often be good ideas for the next project. The most important tasks for the construction plan is to set boundaries for the project, refine the research questions and to ensure that projects finish in a reasonable time frame. - For those who will assess your project.
Those who must assess your project needs to be able to familiarize themselves with it. It could be a funding body, your employer, an ethics board, etc. Many of these have some questions they will ask. Your project plan should be designed to answer the most common questions expected to be raised. You will risk being knocked down or have an lengthy approval process if you don’t address these issues from the start.
It is advisable to finalize the study protocol before starting with the ethics application, grant applications and other approvals that may be needed. Working on the study protocol and the ethics application in parallel often ends up with some mismatch between the study protocol and the ethics application, and the ethics committee will likely pick up that, causing a delay.
Important sections in your study protocol
When describing a project, the description should follow a clear structure and a logical flow. However, it is becoming increasingly common that the study protocol has to be filled out in a web form (for example, when applying for funding). In such cases, you must follow the template provided in the web form. Templates for study protocols can be written slightly differently, but all these variations are similar to each other. A study protocol looks a bit different depending on whether you are trying to describe a project that ultimately leads to one or a few publications, or if you intend to describe a large framework project that leads to several theses and many publications. The template below is more applicable to the former situation.
The structure proposed below can be seen as an attempt to compile the most common variations. It is often a good idea to write down the study protocol as a text document (a Word file, perhaps?) according to the template below. If you later need to fill out a web-based template, you can easily copy, paste, and, if necessary, modify the text from your document. Below, you will also find some examples of how to formulate aims and research questions. These examples are solely intended to illustrate the principles; they are likely not directly applicable to you and your specific project.
Your study protocol should provide the reader with enough information so that the following is clearly evident: a) What we already know, b) What we do not know (the knowledge gap), c) Why it is important to fill this knowledge gap, and d) How you plan to fill the knowledge gap.
You only need to provide just enough information for the reader to understand why you want to conduct the project. Avoid getting side-tracked and writing an entire textbook on the topic that also includes aspects not directly relevant to your specific study. Short and concise is usually best, but you must simultaneously ensure that you provide enough background to clearly justify your project.
Title page
Title pages were more important in the past when everything was printed on paper. With the advent of various web-based templates, the significance of a separate title page has diminished. If you create a title page, include an easy-to-understand and catchy title, the names of the individuals and institutions involved, and finally, contact details for one of the principal investigators.
Summary
A brief summary of your entire study protocol is often required. The summary is important and is read by many people. Writing it is a balancing act between being concise and including the most essential information. If possible, avoid using technical jargon in the summary.
Introduction / Background
Introduce the topic
Begin by describing the topic and why it is important. You may want to mention the prevalence and/or costs associated with the topic. Keep in mind that most people reading your study protocol are not as familiar with the topic as you are.
Problem statement
The reason for conducting a study of any kind is that there is a problem you want to solve. This means that not all the necessary knowledge in the field has been produced yet. The rationale for a project is therefore always to solve a problem. In this paragraph, you describe the unresolved problem associated with the topic.
A common mistake is spending a lot of energy explaining what you want to do, while almost completely failing to explain why it is so important to do it. A good study protocol problematizes the area you want to focus on. This means clearly describing what the problem is. If no problem is identified, there is no longer any reason to conduct a study. Examples of problem descriptions:
- Heart failure is a common yet difficult-to-diagnose condition with high mortality. Adequate treatment improves symptoms and can, in many cases, also prolong the remaining lifespan. The difficulty in diagnosing heart failure early means that many people go untreated for a long time.
- We have a high incidence of postoperative infections.
- We lack good treatment options for Dengue fever.
- We have insufficient information to identify high-risk patients.
- It is incompletely understood whether a multidisciplinary approach for this patient group is applicable within primary care.
- The difficulties of conducting part-time research while working in healthcare have not yet been sufficiently highlighted.
Contextualize the problem
You have now described the problem, which can often be defined as a knowledge gap. It is important to explain why the problem is important. What can be gained by solving the problem? Examples of formulations that put the problem into context could be:
- Between 100 and 400 million people are infected by the dengue virus globally every year. Of these, approximately 96 million people are estimated to actually get sick and develop symptoms known as Dengue fever. Among those who actually get Dengue fever, roughly 1 to 5% (or about 1 in 20) develop what is called severe dengue (previously often referred to as dengue hemorrhagic fever or dengue shock syndrome). It is this condition that can cause internal bleeding, organ failure, and shock, and which requires immediate hospital care.
- Pain is a common symptom in the general population, and according to studies, long-term pain occurs in a frequency as high as 1/3 of the population. 10–15% of the adult population (18–84 years) require care due to their pain, and 5–10% have an extensive need for care due to pain (you may add reference here). Most researchers today agree that patients with psychosomatic problems and long-term pain should ideally be managed according to a multidisciplinary model. Many previous rehabilitation programs utilizing a multidisciplinary model are extensive and require large personnel resources, making them difficult to transfer directly to primary care (you may add reference here). It has also been difficult to show that patients in multidisciplinary care actually achieve better function, increased quality of life, or return to work to a greater extent compared to conventional care. It is thus incompletely understood whether a multidisciplinary approach for this patient group is applicable within primary care. If it could be demonstrated that multidisciplinary care works even in primary care, it would be possible to make major societal gains and achieve reduced suffering for patients.
- Today, we see several employees who begin to falter after long and faithful service in a fast-paced, high-stress work environment, coupled with increasing age. There is reason to believe that it is extremely valuable to ‘rehabilitate in time,’ meaning to give staff who need a change and desire ‘different work’ the chance to transition. It is important that we safeguard a healthy workplace so we can retain our current staff and also recruit new employees. Research and development work (R&D work) is likely an opportunity here, partly to retain the staff we have, and partly to serve as a tool in new recruitment. If R&D work became a more natural part of everyone’s working life, we could conceivably foster staff with higher job satisfaction and a greater ability to evaluate all the new knowledge that is constantly emerging. It is also reasonable to assume that a broader base for R&D work would lead to more people engaging in research and perhaps even defending a doctoral thesis. A broader engagement in R&D could lead to a boost for the development of the entire healthcare system, which in the long run will benefit patients, employers, and staff. However, engaging in R&D is not without its challenges. The difficulties of carrying out R&D work while simultaneously working in clinical healthcare have not yet been sufficiently highlighted.
Describe what has already been done
A common mistake is trying to reinvent the wheel. What have others already done to try and solve the problem? When putting the problem into context, you should mention what others have done to solve it. There is, after all, no need to reinvent the wheel. Once you have defined the topic and the associated problem, you must account for what others have done to try and solve it. This paragraph is a very brief summary of publications describing studies focusing on the problem you have just highlighted. In rare cases, you (and your supervisors) may discover that, to your knowledge, no one has attempted to solve the problem. If that is the case, you should explicitly state this rather than simply omitting previous publications on the topic. If possible, this section should include citations that link to a reference list at the end of the study protocol.
Describe why a new project is needed
In the previous paragraphs, you described the topic, the remaining problem, why the problem is relevant, and what others have done to try to solve it. If others had already solved the problem completely, there would be no need for a new project. Therefore, you must now describe what remains to be solved in light of what others have already done. This constitutes the rationale for your project.
Aim
In a study protocol, it is common for the aim to have its own heading. (In a finalized article published in a scientific journal, it is common for the aim to be woven into the last paragraph of the background section.) The aim briefly describes what you want to do with this study/project and what you hope to gain from it. The transition from the final point of the introduction to the subsequent aim can be likened to passing a baton. Therefore, the aim must perfectly align with what was established as the reason why a new project is needed.
Describe in general terms what you want to achieve with your project. What are you striving for? What is the objective? A common mistake is to state what you believe the results might lead to as your aim. For example, it is inappropriate to state the aim as: “I want to improve the chances for women to successfully quit smoking and remain smoke-free in the long term.” It is much better to formulate the aim as: “To clarify whether the degree of nicotine withdrawal in smokers who quit smoking differs between men and women.” The answer to this latter aim can later be used to make it easier for women to quit smoking, but that potential consequence should not be included as the aim itself.
Research questions and / or hypothesis
If you are planning a project with an empirical-holistic approach (qualitative methods) where no part involves statistics, it is most common to completely refrain from describing specific research questions or hypotheses. In this case, this heading should be omitted.
If your project is evaluated using an empirical-atomistic approach (quantitative methods = statistics), you must clarify your aim in the form of answerable research questions or hypotheses that you can confirm or reject. Primary research questions are the questions you consider to be the most important and for which you have performed an appropriate sample size estimation. Other research questions are secondary research questions. Are your questions formulated in a way that makes them possible to answer? It is crucial that your research questions are actually answerable. This is not the appropriate section to pose rhetorical questions.
A common mistake when writing research questions is to include an appraisal in the research questions:
“Is it better to use treatment A compared to treatment B?” or “Are we doing the right thing?”. These aims include an appraisal that is more or less subjective. A scientific questions and its corresponding scientific answer is without any subjective appraisal. The appraisal may be added as part of the discussion around your results but should never be a part of your aims, research questions or results. The proper research questions should look like “Does treatment A reduce blood pressure more than treatment B?” or “Does the current diagnostic procedures add prognostic information regarding the outcome X?”. Treatment A might be more efficient in lowering blood pressure but it might also cost ten times more than treatment B. Hence, when answering the question if A is better than B you may use the answer to the research question “Does treatment A reduce blood pressure more than treatment B?” …but you would also take into consideration other factors such as costs, side effects, ability to deliver A compared to B, etc. Hence, A might lower the blood pressure more than B but your final appraisal may be that B is the preferred option.
The message here is avoid appraisals completely in your aim and research questions. However, this does not mean that you can’t address the question of appraisal. You may well discuss this in your discussion section when you write up the final manuscript for publication.
Theoretical framework
Within the natural science approach (= the positivist paradigm), where many quantitatively oriented studies operate, the theoretical framework is so self-evident that it should not be described. This heading should therefore not be included in a study protocol where quantitative methods (= statistical methods) are used.
Within qualitative research methodology, the development of methods is still occurring to a greater extent than within quantitative methodology. Therefore, in qualitative studies, it is often a great advantage to describe the perspective (paradigm) from which you operate. Under the heading “theoretical framework,” you should therefore not describe the problem you want to study, but rather the philosophical foundation of science explaining why you choose to process the collected data in a certain way. If you are unaccustomed to working with qualitative research methods, you will likely need help from a supervisor to write this section.
Methods
- Sampling of participants
If your project involves animals or humans describe in detail how participants are going to be selected. From where are they going to be selected. This is where you describe detailed inclusion criteria. - Sampling frame and population
If your project involves humans then the participants in your population of interest can be seen as a sample taken from an underlying population. The sampling frame are those from your population of interest that for practical reasons are eligible for being included. The results from your project can hopefully be generalised to this underlying population. Describe to what population you expect your results to be valid. (Ignore this section if you do not involve humans or if you use qualitative approach) - Exclusion criteria
There might be criteria for later exclusion of participants in longitudinal studies where patients are followed for a short or long time. Thus patients that are included can later be excluded. Exclusion criteria are not just the mirror image of inclusion criteria. They are something else applied after patients are included. If an inclusion criteria is being male then being female is not an exclusion criteria because females were never included. Exclusion criteria are usually not needed in pure cross-sectional studies where patients are not followed over time. Thus, this is the section where you specify specific criteria for later exclusion. - Sample size estimation
In quantitative projects (analysing data with statistics) you want to extrapolate your results to the underlying population. To have a fair chance of doing that your sample must not be too small. On the other hand it should not be unnecessary large bothering more individuals than necessary. This can usually be estimated prior to the study by making some relevant assumptions and using information from previous studies. Describe in detail what assumptions you made and the exact sample size you calculated for all your primary research questions. (Ignore sample size calculation if you use qualitative approach). - Group allocation
In randomized controlled trials describe in detail how participants were allocated to different groups. How was randomization done. Ignore this if participants are not allocated to separate groups. - Interventions
In studies comparing treatments / interventions describe the different treatments given in enough detail so a reader can replicate this. Ignore this if the study does not compare interventions. - Data collection
Describe what kind of data will be collected for analysis. This section should be detailed. Established well known questionnaires do not need to be described in detail, a reference is enough. Is the reliability of the measurement methods known? Where do you plan to conduct the data collection? In the case of open interviews, what opening questions do you plan to ask? - Data analysis
Describe in detail how analysis of collected data will be done. In quantitative approach label this section “Statistical analysis” and give details on statistical methods and variables. It is not enough to simply state that you will use Excel or SPSS. You must also give names on the statistical techniques you have chosen. Here, we are not primarily talking about descriptive statistics (means, standard deviations), but rather about analytical statistics (chi-square, t-tests, regression analysis, etc.). If you can specify exactly which statistical method(s) you plan to use, it lends extra credibility to your study protocol (= increases your chances of securing funding). This demonstrates that you have thought through all the important details of the project. If you use a qualitative approach describe the steps in your analysis and if possible label your approach (such as “Grounded theory” or Phenomenology according to Giorgi”).
Expected results
Usually, the justifications for the project that you provided in the introduction are sufficient. However, a few funding agencies may additionally require this heading. In this section, you state the potential results the project might yield and their conceivable significance. This is easier to speculate on when using an empirical-atomistic approach that relies on statistics. It is more difficult to form an opinion on this in projects using an empirical-holistic approach (qualitative methods).
Budget
Describe the anticipated costs and who will pay for them. Different funding agencies usually have different preferences regarding the breakdown of costs. For example, you may be required to divide the costs into: material costs, personnel costs (broken down by professional category; include social security contributions and holiday pay), and other costs (advertisements, literature, postage, purchase of small items without lasting value, etc.). If no financial resources are needed, you should clearly state this.
Time line
Describe when the different steps in the project will start and finish. It is quite common (and practical) to use a Gantt chart.
Contingency plan
There are always a chance that something goes wrong. One of the most common problems encountered is that recruitment of participants / observations is slower than anticipated. What potential problems have you identified and what contingency plans do you have in place? Writing about this increases the trustworthiness in your proposed project.
Reference list
Parts of the introduction/background (and sometimes also the methods section) should contain citations to previous publications. These should be compiled in a reference list at the end of the document. In-text citations can be formatted in different ways. This depends on where you are submitting the study protocol. A common method is to use sequential numbers in parentheses within the text. The references are numbered in the order you refer to them. At the end, there will be a reference list with the references in numerical order. In qualitative studies, it is common to state the author’s name and the year of publication in the running text. In the reference list, the references are then sorted alphabetically by the author’s name.
Figures and tables
If you need to use figures or tables, there are different ways to handle them. You can either intersperse them within the running text, or you can gather them at the end under a specific heading or as appendices. If you want to refer to a table or figure in the text, indicate this in parentheses, such as “(Table 1)”, “(Figure 1)”, or “(Appendix 1)”. If you place them at the end, put all the tables first, followed by all the figures in the order they are mentioned in the text.
Ethical aspects
Even if not all funding agencies require you to describe ethical aspects, you should always think this through for your own sake and write it down in the study protocol. Are there ethical problems with your project? Can the potential results justify the approach? As a minimum, there is almost always a minor ethical issue in that you are taking up individuals’ time when collecting information, or alternatively, intruding on their privacy if you are accessing data about them.
Date – Version – Page number and logotypes
Sometimes you write the study protocol directly in a website where you apply for a grant or an ethics approval. Sometimes you write your study protocol as a Word file that is to be attached to an application. In the latter situation it is good practice to let each new version get its own version number that should also be dated. Version number, date and page number should be placed in the footer, visible on all pages. Logotypes should be placed in the header.
Common pitfalls
Some mistakes have been touched upon above. Some other common mistakes in study protocols are:
- Writing too much in the background/introduction, turning it into a textbook. You can assume that those reading your study protocol have some basic prior knowledge of research methodology. Regarding the topic of your project, do not describe everything that can be said about it—only what is needed to explain why a new project is necessary.
- Writing too little in the methods section, so that the ethics committee cannot assess the scientific merit of your application.
- Forgetting to mention previous publications on the topic.
- Forgetting to clearly explain why a new study is needed in light of all previous publications. This might be obvious to you, but it is certainly not as clear to the members of an ethics committee.
- Too much focus on the local situation. The goal of a study is for the results to be of interest to people beyond your immediate circle. You are likely doing something that many others would find interesting. This general interest is diminished by using the first person (“I”) or by naming local units right in the title. Even local findings can provide important lessons for people outside the local context. Try to write your application so that the potential takeaways can be understood by, and remain interesting to, “outsiders.” There are many alternative ways to phrase things:
Instead of “I think that…”, write “It is reasonable to assume that…”
Instead of “I think it would be interesting to…”, write “It would be of interest to…”
Instead of “Title: Introduction of written information to parents of children with otitis at Grönköping Primary Care Center”, write “Title: Introduction of written information to parents during primary care visits caused by acute otitis media.”
Instead of “I have received search assistance from a librarian regarding studies concerning the above problem, but have not found any similar study”, write “Studies addressing this problem are lacking.” - Failing to describe details regarding data analysis, such as the specific names of statistical or qualitative methods. This gives the impression that your study is not well planned.
- Failing to present a sample size calculation (if using a quantitative approach). This also gives the impression that the study is poorly planned.
Examples of study protocols
Click on the title below to read / download the example of a study protocol. These examples are uploaded as Word files so you can start modifying them directly to be your study protocol. (The examples below do not claim to be perfect.)
- Effect of promoting current local research activities on large monitors on the population’s interest in health-related research: a randomised controlled trial.
- Oral corticosteroids for painful acute otitis externa (swimmer’s ear): A triple-blind randomised controlled trial.
- Using a point of care test to support management of patients attending for a sore throat.