justification of study in research

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How to Write the Rationale of the Study in Research (Examples)

What is the Rationale of the Study?

The rationale of the study is the justification for taking on a given study. It explains the reason the study was conducted or should be conducted. This means the study rationale should explain to the reader or examiner why the study is/was necessary. It is also sometimes called the “purpose” or “justification” of a study. While this is not difficult to grasp in itself, you might wonder how the rationale of the study is different from your research question or from the statement of the problem of your study, and how it fits into the rest of your thesis or research paper. 

The rationale of the study links the background of the study to your specific research question and justifies the need for the latter on the basis of the former. In brief, you first provide and discuss existing data on the topic, and then you tell the reader, based on the background evidence you just presented, where you identified gaps or issues and why you think it is important to address those. The problem statement, lastly, is the formulation of the specific research question you choose to investigate, following logically from your rationale, and the approach you are planning to use to do that.

Table of Contents:

How to write a rationale for a research paper , how do you justify the need for a research study.

• Study Rationale Example: Where Does It Go In Your Paper?

The basis for writing a research rationale is preliminary data or a clear description of an observation. If you are doing basic/theoretical research, then a literature review will help you identify gaps in current knowledge. In applied/practical research, you base your rationale on an existing issue with a certain process (e.g., vaccine proof registration) or practice (e.g., patient treatment) that is well documented and needs to be addressed. By presenting the reader with earlier evidence or observations, you can (and have to) convince them that you are not just repeating what other people have already done or said and that your ideas are not coming out of thin air. 

Once you have explained where you are coming from, you should justify the need for doing additional research–this is essentially the rationale of your study. Finally, when you have convinced the reader of the purpose of your work, you can end your introduction section with the statement of the problem of your research that contains clear aims and objectives and also briefly describes (and justifies) your methodological approach. 

When is the Rationale for Research Written?

The author can present the study rationale both before and after the research is conducted. 

• Before conducting research : The study rationale is a central component of the research proposal . It represents the plan of your work, constructed before the study is actually executed.
• Once research has been conducted : After the study is completed, the rationale is presented in a research article or  PhD dissertation  to explain why you focused on this specific research question. When writing the study rationale for this purpose, the author should link the rationale of the research to the aims and outcomes of the study.

What to Include in the Study Rationale

Although every study rationale is different and discusses different specific elements of a study’s method or approach, there are some elements that should be included to write a good rationale. Make sure to touch on the following:

• A summary of conclusions from your review of the relevant literature
• What is currently unknown (gaps in knowledge)
• Inconclusive or contested results  from previous studies on the same or similar topic
• The necessity to improve or build on previous research, such as to improve methodology or utilize newer techniques and/or technologies

There are different types of limitations that you can use to justify the need for your study. In applied/practical research, the justification for investigating something is always that an existing process/practice has a problem or is not satisfactory. Let’s say, for example, that people in a certain country/city/community commonly complain about hospital care on weekends (not enough staff, not enough attention, no decisions being made), but you looked into it and realized that nobody ever investigated whether these perceived problems are actually based on objective shortages/non-availabilities of care or whether the lower numbers of patients who are treated during weekends are commensurate with the provided services.

In this case, “lack of data” is your justification for digging deeper into the problem. Or, if it is obvious that there is a shortage of staff and provided services on weekends, you could decide to investigate which of the usual procedures are skipped during weekends as a result and what the negative consequences are. 

In basic/theoretical research, lack of knowledge is of course a common and accepted justification for additional research—but make sure that it is not your only motivation. “Nobody has ever done this” is only a convincing reason for a study if you explain to the reader why you think we should know more about this specific phenomenon. If there is earlier research but you think it has limitations, then those can usually be classified into “methodological”, “contextual”, and “conceptual” limitations. To identify such limitations, you can ask specific questions and let those questions guide you when you explain to the reader why your study was necessary:

Methodological limitations

• Did earlier studies try but failed to measure/identify a specific phenomenon?
• Was earlier research based on incorrect conceptualizations of variables?
• Were earlier studies based on questionable operationalizations of key concepts?
• Did earlier studies use questionable or inappropriate research designs?

Contextual limitations

• Have recent changes in the studied problem made previous studies irrelevant?
• Are you studying a new/particular context that previous findings do not apply to?

Conceptual limitations

• Do previous findings only make sense within a specific framework or ideology?

Study Rationale Examples

Let’s look at an example from one of our earlier articles on the statement of the problem to clarify how your rationale fits into your introduction section. This is a very short introduction for a practical research study on the challenges of online learning. Your introduction might be much longer (especially the context/background section), and this example does not contain any sources (which you will have to provide for all claims you make and all earlier studies you cite)—but please pay attention to how the background presentation , rationale, and problem statement blend into each other in a logical way so that the reader can follow and has no reason to question your motivation or the foundation of your research.

Background presentation

Since the beginning of the Covid pandemic, most educational institutions around the world have transitioned to a fully online study model, at least during peak times of infections and social distancing measures. This transition has not been easy and even two years into the pandemic, problems with online teaching and studying persist (reference needed) . 

While the increasing gap between those with access to technology and equipment and those without access has been determined to be one of the main challenges (reference needed) , others claim that online learning offers more opportunities for many students by breaking down barriers of location and distance (reference needed) .  

Rationale of the study

Since teachers and students cannot wait for circumstances to go back to normal, the measures that schools and universities have implemented during the last two years, their advantages and disadvantages, and the impact of those measures on students’ progress, satisfaction, and well-being need to be understood so that improvements can be made and demographics that have been left behind can receive the support they need as soon as possible.

Statement of the problem

To identify what changes in the learning environment were considered the most challenging and how those changes relate to a variety of student outcome measures, we conducted surveys and interviews among teachers and students at ten institutions of higher education in four different major cities, two in the US (New York and Chicago), one in South Korea (Seoul), and one in the UK (London). Responses were analyzed with a focus on different student demographics and how they might have been affected differently by the current situation.

How long is a study rationale?

In a research article bound for journal publication, your rationale should not be longer than a few sentences (no longer than one brief paragraph). A  dissertation or thesis  usually allows for a longer description; depending on the length and nature of your document, this could be up to a couple of paragraphs in length. A completely novel or unconventional approach might warrant a longer and more detailed justification than an approach that slightly deviates from well-established methods and approaches.

Consider Using Professional Academic Editing Services

Now that you know how to write the rationale of the study for a research proposal or paper, you should make use of our free AI grammar checker , Wordvice AI, or receive professional academic proofreading services from Wordvice, including research paper editing services and manuscript editing services to polish your submitted research documents.

You can also find many more articles, for example on writing the other parts of your research paper , on choosing a title , or on making sure you understand and adhere to the author instructions before you submit to a journal, on the Wordvice academic resources pages.

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• Writing Tips

How to Justify Your Methods in a Thesis or Dissertation

4-minute read

• 1st May 2023

Writing a thesis or dissertation is hard work. You’ve devoted countless hours to your research, and you want your results to be taken seriously. But how does your professor or evaluating committee know that they can trust your results? You convince them by justifying your research methods.

What Does Justifying Your Methods Mean?

In simple terms, your methods are the tools you use to obtain your data, and the justification (which is also called the methodology ) is the analysis of those tools. In your justification, your goal is to demonstrate that your research is both rigorously conducted and replicable so your audience recognizes that your results are legitimate.

The formatting and structure of your justification will depend on your field of study and your institution’s requirements, but below, we’ve provided questions to ask yourself as you outline your justification.

Why Did You Choose Your Method of Gathering Data?

Does your study rely on quantitative data, qualitative data, or both? Certain types of data work better for certain studies. How did you choose to gather that data? Evaluate your approach to collecting data in light of your research question. Did you consider any alternative approaches? If so, why did you decide not to use them? Highlight the pros and cons of various possible methods if necessary. Research results aren’t valid unless the data are valid, so you have to convince your reader that they are.

How Did You Evaluate Your Data?

Collecting your data was only the first part of your study. Once you had them, how did you use them? Do your results involve cross-referencing? If so, how was this accomplished? Which statistical analyses did you run, and why did you choose them? Are they common in your field? How did you make sure your data were statistically significant ? Is your effect size small, medium, or large? Numbers don’t always lend themselves to an obvious outcome. Here, you want to provide a clear link between the Methods and Results sections of your paper.

Did You Use Any Unconventional Approaches in Your Study?

Most fields have standard approaches to the research they use, but these approaches don’t work for every project. Did you use methods that other fields normally use, or did you need to come up with a different way of obtaining your data? Your reader will look at unconventional approaches with a more critical eye. Acknowledge the limitations of your method, but explain why the strengths of the method outweigh those limitations.

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What Relevant Sources Can You Cite?

You can strengthen your justification by referencing existing research in your field. Citing these references can demonstrate that you’ve followed established practices for your type of research. Or you can discuss how you decided on your approach by evaluating other studies. Highlight the use of established techniques, tools, and measurements in your study. If you used an unconventional approach, justify it by providing evidence of a gap in the existing literature.

Two Final Tips:

●  When you’re writing your justification, write for your audience. Your purpose here is to provide more than a technical list of details and procedures. This section should focus more on the why and less on the how .

●  Consider your methodology as you’re conducting your research. Take thorough notes as you work to make sure you capture all the necessary details correctly. Eliminating any possible confusion or ambiguity will go a long way toward helping your justification.

In Conclusion:

Your goal in writing your justification is to explain not only the decisions you made but also the reasoning behind those decisions. It should be overwhelmingly clear to your audience that your study used the best possible methods to answer your research question. Properly justifying your methods will let your audience know that your research was effective and its results are valid.

Want more writing tips? Check out Proofed’s Writing Tips and Academic Writing Tips blogs. And once you’ve written your thesis or dissertation, consider sending it to us. Our editors will be happy to check your grammar, spelling, and punctuation to make sure your document is the best it can be. Check out our services for free .

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Rationale for the Study

It is important for you to be able to explain the importance of the research you are conducting by providing valid arguments. Rationale for the study, also referred to as justification for the study, is reason why you have conducted your study in the first place. This part in your paper needs to explain uniqueness and importance of your research. Rationale for the study needs to be specific and ideally, it should relate to the following points:

1. The research needs to contribute to the elimination of a gap in the literature. Elimination of gap in the present literature is one of the compulsory requirements for your study. In other words, you don’t need to ‘re-invent the wheel’ and your research aims and objectives need to focus on new topics. For example, you can choose to conduct an empirical study to assess the implications of COVID-19 pandemic on the numbers of tourists visitors in your city. This might be previously undressed topic, taking into account that COVID-19 pandemic is a relatively recent phenomenon.

Alternatively, if you cannot find a new topic to research, you can attempt to offer fresh perspectives on existing management, business or economic issues. For example, while thousands of studies have been previously conducted to study various aspects of leadership, this topic as far from being exhausted as a research area. Specifically, new studies can be conducted in the area of leadership to analyze the impacts of new communication mediums such as TikTok, and other social networking sites on leadership practices.

You can also discuss the shortcomings of previous works devoted to your research area. Shortcomings in previous studies can be divided into three groups:

a) Methodological limitations . Methodology employed in previous study may be flawed in terms of research design, research approach or sampling.

b) Contextual limitations . Relevance of previous works may be non-existent for the present because external factors have changed.

c) Conceptual limitations . Previous studies may be unjustifiably bound up to a particular model or an ideology.

While discussing the shortcomings of previous studies you should explain how you are going to correct them. This principle is true to almost all areas in business studies i.e. gaps or shortcomings in the literature can be found in relation to almost all areas of business and economics.

2. The research can be conducted to solve a specific problem. It helps if you can explain why you are the right person and in the right position to solve the problem. You have to explain the essence of the problem in a detailed manner and highlight practical benefits associated with the solution of the problem. Suppose, your dissertation topic is “a study into advantages and disadvantages of various entry strategies into Chinese market”. In this case, you can say that practical implications of your research relates to assisting businesses aiming to enter Chinese market to do more informed decision making.

Alternatively, if your research is devoted to the analysis of impacts of CSR programs and initiatives on brand image, practical contributions of your study would relate to contributing to the level of effectiveness of CSR programs of businesses.

Additional examples of studies that can assist to address specific practical problems may include the following:

• A study into the reasons of high employee turnover at Hanson Brick
• A critical analysis of employee motivation problems at Esporta, Finchley Road, London
• A research into effective succession planning at Microsoft
• A study into major differences between private and public primary education in the USA and implications of these differences on the quality of education

However, it is important to note that it is not an obligatory for a dissertation   to be associated with the solution of a specific problem. Dissertations can be purely theory-based as well. Examples of such studies include the following:

• Born or bred: revising The Great Man theory of leadership in the 21 st century
• A critical analysis of the relevance of McClelland’s Achievement theory to the US information technology industry
• Neoliberalism as a major reason behind the emergence of the global financial and economic crisis of 2007-2009
• Analysis of Lewin’s Model of Change and its relevance to pharmaceutical sector of France

3. Your study has to contribute to the level of professional development of the researcher . That is you. You have to explain in a detailed manner in what ways your research contributes to the achievement of your long-term career aspirations.

For example, you have selected a research topic of “ A critical analysis of the relevance of McClelland’s Achievement theory in the US information technology industry ”.  You may state that you associate your career aspirations with becoming an IT executive in the US, and accordingly, in-depth knowledge of employee motivation in this industry is going to contribute your chances of success in your chosen career path.

Therefore, you are in a better position if you have already identified your career objectives, so that during the research process you can get detailed knowledge about various aspects of your chosen industry.

My e-book, The Ultimate Guide to Writing a Dissertation in Business Studies: a step by step assistance offers practical assistance to complete a dissertation with minimum or no stress. The e-book covers all stages of writing a dissertation starting from the selection to the research area to submitting the completed version of the work within the deadline.

John Dudovskiy

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• Indian J Dermatol
• v.62(5); Sep-Oct 2017

Summary and Synthesis: How to Present a Research Proposal

Maninder singh setia.

From the MGM Institute of Health Sciences, Navi Mumbai, Maharashtra, India

Saumya Panda

1 Department of Dermatology, KPC Medical College, Kolkata, West Bengal, India

This concluding module attempts to synthesize the key learning points discussed during the course of the previous ten sets of modules on methodology and biostatistics. The objective of this module is to discuss how to present a model research proposal, based on whatever was discussed in the preceding modules. The lynchpin of a research proposal is the protocol, and the key component of a protocol is the study design. However, one must not neglect the other areas, be it the project summary through which one catches the eyes of the reviewer of the proposal, or the background and the literature review, or the aims and objectives of the study. Two critical areas in the “methods” section that cannot be emphasized more are the sampling strategy and a formal estimation of sample size. Without a legitimate sample size, none of the conclusions based on the statistical analysis would be valid. Finally, the ethical parameters of the study should be well understood by the researchers, and that should get reflected in the proposal.

As we reach the end of an exhaustive module encompassing research methods and biostatistics, we need to summarize and synthesize the key learning points, to demonstrate how one may utilize the different sections of the module to undertake research projects of different kinds. After all, the practical purpose behind publishing such a module is to facilitate the preparation of high quality research proposals and protocols. This concluding part will make an attempt to provide a window to the different sections of the module, underlining the various aspects of design and analysis needed to formulate protocols applicable to different kinds of clinical research in dermatology.

Components of a Research Proposal

The goal of a research proposal is to present and justify the need to study a research problem and to present the practical ways in which the proposed study should be conducted. A research proposal is generally meant to be presented by an investigator to request an agency or a body to support research work in the form of grants. The vast majority of research proposals, in India, however, are not submitted to agency or body for grants, simply because of the paucity of such agencies, bodies, and research grants. Most are academic research proposals, self-financed, and submitted to scientific and ethics committee of an institution. The parts of a proposal include the title page, abstract/project summary, table of contents, introduction, background and review of literature, and the research protocol.

The title page should contain the personal data pertaining to the investigators, and title of the project, which should be concise and comprehensive at the same time. The table of contents, strictly speaking, is not necessary for short proposals. The introduction includes a statement of the problem, purpose, and significance of the research.

The protocol is the document that specifies the research plan. It is the single most important quality control tool for all aspects of a clinical research. It is the instrument where the researcher explains how data will be collected, including the calculation for estimating sample size, and what outcome variables to measure.

A complete clinical research protocol includes the following:

Study design

• Precise definition of the disease or problem
• Completely defined prespecified primary and secondary outcome measures, including how and when these will be assessed
• Clear description of variables
• Well-defined inclusion and exclusion criteria
• Efficacy and safety parameters
• Whenever applicable, stopping guidelines and parameters of interim analyses
• Sample size calculation
• Randomization details
• Plan of statistical analysis
• Detailed description of interventions
• A chronogram of research flow (Gantt chart)
• Informed consent document
• Clinical research form
• Details of budget; and
• References.

(Modified from: Bagatin et al ., 2013).

Project Summary

The project summary is a brief document that consists of an overview, and discusses the intellectual merits, and broader impacts of the research project. Each of these three sections is required to be present and must be clearly defined. The project summary is one of the most important parts of the proposal. It is likely the first thing a reviewer will read, and is the investigators’ best chance to grab their interest, and convince them of the importance, and quality, of their research before they even read the proposal. Though it is the first proposal element in order, many applicants prefer to write the project summary last, after writing the protocol. This allows the writer to better avoid any inconsistencies between the two.

The overview specifies the research goal and it should demonstrate that this goal fits with the principal investigator's long-term research goals. It should specify the proposed research approach and the educational goal of the research project.

The intellectual merits (the contribution your research will make to your field) should specify the current state of knowledge in the field, and where it is headed. It should also clarify what your research will add to the state of knowledge in the field. Furthermore, important to state is what your research will do to enhance or enable other researches in the field. Finally, one should answer why your research is important for the advancement of the field.

The broader impacts (the contribution the research will make to the society) should answer the questions on the benefit to the society at large from the research, and the possible applications of the research, and why the general public would care. It should also clarify how the research can benefit the site of research (medical college or university, etc.) and the funding agency.

Background and Review of Literature

This is an important component of the research protocol. The review should discuss all the relevant literature, the method used in the literature, the lacunae in the literature, and justify the proposed research. We have provided a list of the useful databases in the section on systematic reviews and meta-analysis (Setia, 2017). Some of these are PubMed, Cochrane database, EMBASE, and LILACS.

Provide a critical analysis of the literature

The researcher should not provide a descriptive analysis of literature. For instance, the literature reviews should not be a list of one article followed by the next article. It should be a critical analysis of literature.

A study by XXXX et al . found that the prevalence of psoriasis was 20%. It was a hospital-based study conducted in North India. The prevalence was 35% in males and 12% in females.

Another study by YYYYY et al . found that the prevalence of psoriasis was 14%. The study was conducted in a private clinic in North India. The prevalence was 8% in males and 18% in females.

A third study by ZZZZZ et al . found that the prevalence of psoriasis was 5%. This study was a community-based study. The prevalence was 7% in males and 3% in females.

In this type of review, the researcher has described all the studies. However, it is useful to understand the findings of these three studies and summarize them in researcher's own words.

A possible option can be “ The reported prevalence of psoriasis in the Indian population varied from 5% to 20%. In general, it was higher in hospital-based studies and lower in community-based studies. There was no consistent pattern in the prevalence of psoriasis in males and females. Though some studies found the prevalence to be higher in males, others reported that females had a higher prevalence .”

Discuss the limitations and lacunae of these studies

The researcher should discuss the limitations of the studies. These could be the limitations that the authors have presented in the manuscript or the ones that the researcher has identified. Usually, the current research proposal should try to address the limitations of a previous study.

A study by BBBB et al : “ One of the main limitations of our study was the lack of objective criteria for assessing anemia in patients presenting with psoriasis. We classified the patients based on clinical assessment of pallor .”

The present proposal can mention “ Though previous studies have assessed the association between anemia and psoriasis, they have not used any objective criteria (such as hemoglobin or serum ferritin levels). Furthermore, pallor was evaluated by three clinicians; the authors have not described the agreement between these clinicians .”

In the above example, the authors have stated the limitation of their research in the manuscript. However, in the review of literature, the researcher has added another limitation. It is important to convince the reviewers that the researcher has read and understood the literature. It is also important that some or most of these lacunae should be addressed in the present proposal as far as possible.

Justify the present proposal by review

The researcher should adequately justify the present proposal based on the review of literature. The justification should not only be for the research question, but also the methods, study design, variables of interest, study instruments or measurements, and statistical methods of choice. Sometimes, the justification can be purely statistical. For example, all the previous studies have used cross-sectional data or cross-sectional analysis of longitudinal data in their manuscripts. The present proposal will use methods used for longitudinal data analysis. The researcher should justify the benefit of these methods over the previous statistical methods.

In short, the review should not be a “laundry list” of all the articles. The review should be able to convince the reader that the present research is required and it builds on the existing literature (either as a novel research question, new measurement of the outcome, a better study design, or advanced and appropriate statistical methods).

Kindly try to avoid this justification: “ It has not been done in our center .”

Aims and Objectives

The “aim” of the study is an overarching goal of the study. The objectives are measurable and help the researcher achieve the overall aim.

For example, the overall aim of our study is to assess the long-term health of patients of psoriasis.

The specific objectives are:

• To record the changes in Psoriasis Area and Severity Index (PASI) score in patients with psoriasis over a period of 5 years
• To study the side effects of medications in these patients over a period of 5 years.

It is important to clearly state the objectives, since the research proposal should be designed to achieve these objectives.

For example, the methods should describe the following:

• How will the researcher answer the first objective?
• Where will the researcher recruit the study participants (study site and population)?
• Which patients of psoriasis will be recruited (inclusion and exclusion criteria)?
• What will be the design of the study (cohort, etc.)?
• What are all the variables to be measured to achieve the study outcomes (exposure and outcome variables)?
• How will the researcher measure these variables (clinical evaluation, history, serological examination, etc.)?
• How will the researcher record these data (clinical forms, etc.)?
• How will the researcher analyze the data that have been collected?
• Are there any limitations of these methods? If so, what has the researcher done to minimize the limitations?

All the ten modules on research methodology have to be read and grasped to plan and design any kind of research applicable to one's chosen field. However, some key areas have been outlined below with examples to appreciate the same in an easier manner.

The study setting must be specified. This should include both the geographical location and the population from which the study sample would be recruited.

“The study took place at the antiretroviral therapy clinic of Queen Elizabeth Central Hospital in Blantyre, Malawi, from January 2006 to April 2007. Blantyre is the major commercial city of Malawi, with a population of 1,000,000 and an estimated HIV prevalence of 27% in adults in 2004” (Ndekha et al ., 2009).

This is a perfect example of description of a study setting which underscores the importance of planning it in detail a priori .

Study population, sampling strategy, and sample size

Study population has to be clearly and precisely defined. For example, a study on atopic dermatitis may be conducted upon patients defined according to the UK Working Party's modified diagnostic criteria, or the Hanifin and Rajka's criteria, or some other criteria defined by the investigators. However, it should always be prespecified within the protocol.

Similarly, the eligibility criteria of the participants for the study must be explicit. One truism that is frequently forgotten is that the inclusion and exclusion criteria are mutually exclusive, and one is not the negative image of the other. Eligible cases are included according to a set of inclusion criteria, and this is followed by administration of the exclusion criteria. Thus, in fact, they can never be the negative image of each other.

“Eligible participants were all adults aged 18 or over with HIV who met the eligibility criteria for antiretroviral therapy according to the Malawian national HIV treatment guidelines (WHO clinical stage III or IV or any WHO stage with a CD4 count < 250/mm 3 ) and who were starting treatment with a BMI < 18.5. Exclusion criteria were pregnancy and lactation or participation in another supplementary feeding program” (Ndekha et al ., 2009).

To put in perspective the point we made about inclusion and exclusion criteria, in the above example, “age above 18 years” or “CD4 count >250/mm 3 ” cannot be exclusion criteria, as these have already been excluded.

Sampling strategy has been adequately discussed in the Module 5 of the Methodology series (Setia, 2016). A few points are worth repeating:

• The sampling strategy should never be misrepresented. Example: If you have not done random sampling, no big deal. There are other legitimate sampling strategies available for your study. But once you have mentioned “random sampling” in your protocol, you cannot resort to purposive sampling
• Sometimes, the researcher might want to know the characteristics of a certain problem within a specific population, without caring for generalizability of results. In such a scenario, purposive sampling may be resorted to
• Nonprobability sampling methods such as consecutive consenting sampling or any such convenience sampling are perfectly legitimate and easy to do, particularly in case of dissertations where time and resources are limited.

Sample size is one of the most misunderstood, yet fundamentally important, issues among clinicians and has to be addressed once the study objectives have been set and the design has been finalized. Too small a sample means that there would be a failure to detect change following test intervention. A sample larger than necessary may also result in bad quality data. In either case, there would be ethical problems and wastage of resources. The researcher needs just enough samples to draw accurate inferences, which would be adequately powered (Panda, 2015).

Estimation of sample size has been dealt with adequately in the Module 5 biostatistics series (Hazra et al ., 2016), including the different mathematical derivations and the available software. Sample size determination is a statistical exercise based on the probability of errors in testing of hypothesis, power of the sample, and effect size. Although, relatively speaking, these are simple concepts to grasp, a large number of different study designs and analytical methods lead to a bewilderingly large number of formulae for determining sample size. Thus, the software are really handy and are becoming increasingly popular.

The study design defines the objectives and end points of the study, the type and manner of data collection, and the strategy of data analysis (Panda 2015). The different types of clinical studies have been depicted in Figure 1 . The suitability of various study designs vis-à-vis different types of research questions is summarized in Table 1 .

Types of study (Source: Panda, 2015)

Research questions vis-a-vis study designs

In our previous series of ten modules on methodology, we have discussed all these different kinds of studies and more. Some key issues that require reiteration are given below:

• The control of a case–control study and that of a randomized controlled trial is more different from each other than chalk is from cheese. The former is an observational study, while the latter is an interventional one. Every study with a control group is not a case–control study. For a study to be classified as a case–control study, the study should be an observational study and the participants should be recruited based on their outcome status (Setia, 2016). Apparently, this is not so difficult to understand, yet even now we have publications which confuse between the different kinds of controls (Bhanja et al ., 2015)
• Due to the fact that the outcome and exposure are assessed at the same time point in a cross-sectional study, it is pretty difficult, if not impossible, to derive causal relationships from such a study. At most, one may establish statistical association between exposures and outcomes by calculating the odds ratio. However, these associations must not be confused with causation.
• It is generally said that a cohort design may not be efficient for rare outcomes. However, if the rare outcome is common in some exposures, it may be useful to follow a cohort design. For example, melanoma is a rare condition in India. Hence, if we follow individuals to study the incidence of melanoma, it may not be efficient. However, if we know that, in India, acral lentiginous melanoma is the most commonly reported variant, we should follow a cohort of individuals with acral lentiginous and study the incidence of melanoma in this group (Setia, 2016).

Clinical researchers should also be accustomed with observational designs beyond case–control, cohort, and cross-sectional studies. Sometimes, the unit of analysis has to be a group or aggregate rather than the individual. Consider the following example:

The government introduced the supplementation of salt with iodine for about 20 years. However, not all states have used the same level of iodine in salt. Certain hilly states have used higher quantities compared with other states. Incidentally, you read a report that high iodine levels are associated with psoriasis. You are intrigued to find if introduction of iodine has altered the picture of psoriasis in the country. You feel compelled to design a study to answer this question .

It is obvious that here the unit of study cannot be individuals, but a large population distributed in a certain geographical area. This is the domain of ecologic studies. An allied category of observational studies is named “natural experiments,” where the exposure is not assigned by the investigator (as in an interventional study), but through “natural processes.” These may be through changes in the existing regulations or public policies or, may be, through introduction of new laws (Setia, 2017).

Another category of research questions that cannot be satisfactorily captured by all the quantitative methods described earlier, like social stigma experienced by patients or their families with, say, vitiligo, leprosy, or sexually transmitted infections, are best dealt with by qualitative research. As can be seen by the examples given above, this is a type of research which is very relevant to medical research, yet to which the regular medical researcher has got a very poor exposure, if any. We shall encourage interested researchers to take a look at the 10 th Module of the Methodology series that specifically deals with qualitative research (Setia, 2017).

Clinical studies are experiments that are not conducted in laboratories but in controlled real-life settings on human subjects with some disease. Hence, designing a study involves many pragmatic considerations aside pure methodology. Thus, factors to consider when selecting a study design are objectives of the study, time frame, treatment duration, carryover effects, cost and logistics, patient convenience, statistical considerations, sample size, etc. (Panda, 2015).

Certain truisms regarding study designs should always be remembered: a study design has to be tailored to objectives. The same question may be answered by different designs. The optimum design has to be based on workforce, budgetary allocation, infrastructure, and clinical material that may be commanded by the researchers. Finally, no design is perfect, and there is no design to provide a perfect answer to all research questions relevant to a particular problem (Panda, 2015).

Variables of interest and collection of these variables

Data structure depends on the characteristics of the variables [ Figure 2 ]. A variable refers to a particular character on which a set of data are recorded. Data are thus the values of a variable (Hazra et al ., 2016).

Types of data and variables (Source: Panda, 2015)

Quantitative data always have a proportional scale among values, and can be either discrete (e.g., number of moles) or continuous (e.g., age). Qualitative data can be either nominal (e.g., blood groups) or ordinal (e.g., Fitzpatrick's phototypes I-VI). Variables can be binary or dichotomous (male/female) or multinomial or polychotomous (homosexual/bisexual/heterosexual) (Panda, 2015).

Changing data scales is possible so that numerical data may become ordinal and ordinal data may become nominal. This may be done when the researcher is not confident about the accuracy of the measuring instrument, is unconcerned about the loss of fine detail, or where group numbers are not large enough to adequately represent a variable of interest. It may also make clinical interpretation easier (Hazra et al ., 2016).

The variables whose effects are observed on other variables are known as independent variables (e.g., risk factors). The latter kind of variables that change as a result of independent variables are known as dependent variables (i.e., outcome). Confounders are those variables that influence the relation between independent and dependent variables (e.g., the clinical effect of sunscreen used as part of a test intervention regimen in melasma). If the researcher fails to control or eliminate the confounder, it will damage the internal validity of an experiment (Panda, 2015).

Biostatistics begins with descriptive statistics that implies summarizing a collection of data from a sample or population. An excellent overview of descriptive statistics has been given in the Module 1 of the Biostatistics series (Hazra et al ., 2016). We would encourage every researcher to embark on designing and collecting data on their own to go through this particular module to have a clear idea on how to proceed further.

Statistical methods

As briefly discussed earlier, the “methods” section should also include a detailed description of statistical methods. It is best to describe the methods for each objective.

For example: Which statistical methods will the researcher use to study the changes in PASI score over time?

It is important to first identify the nature of the outcome – will it be linear or categorical?

• It may be noticed that the PASI is a score and can range from 0 to 72. The researcher can measure the actual score and assess the changes in score. Thus, the researcher will use methods for statistical analysis of continuous data (such as means, standard deviations, t -test, or linear regressions)
• However, the researcher may choose to cut off the PASI score at 60 (of course, there has to be justification!) and call it severe psoriasis. Thus, the researcher will have an outcome variable with two outcomes (Yes: >60 PASI, and No: <60 PASI). Thus, in this case, the researcher will use methods for statistical analysis of categorical data (proportions, Chi-square test, or logistic regression models).

The statistical methods have been described in detail in the Biostatistics section of the series. The reader is encouraged to read all the sections to understand these methods. However, the key points to remember are:

• Identify the nature of the outcome for each objective
• Describe the statistical methods separately for each objective
• Identify the methods to handle confounding and describe them in the statistical methods
• If the researcher is using advanced statistical methods or specific tools, please provide reference to these methods
• Provide the name of the statistical software (including the version) that will be used for data analysis in the present study
• Do not provide a laundry list of all the statistical methods. It just shows that the researcher has not understood the relevance of statistics in the study design.

Multivariate models

In general, multivariate analyses are used in studies and research proposals. These analyses are useful to adjust for confounding (though these are also useful to test for interaction, we shall discuss confounding in this section). For example, we propose to compare two different types of medications in psoriasis. We have used secondary clinical data for this study. The outcome of interest is PASI score. We have collected data on the type of medication, age, sex, and alcohol use. When we compare the PASI score in these two groups, we will use t -test (if linear comparison) or Chi-square test (if PASI is categorized – as described earlier). However, it is possible that age, sex, and alcohol use may also play a role in the clinical progression of psoriasis (which is measured as PASI score). Thus, the researcher would like to account for differences in these variables in the two groups. This can be done using multivariate analytical methods (such as linear regression for continuous variables and logistic regression for categorical dichotomous variables). This is a type of mathematical model in which we include multiple variables: the main explanatory variable (type of drug in this study) and potential confounders (age, sex, and alcohol use in this study). Thus, the outcome (PASI score) after multivariate analyses will be “adjusted” for age, sex, and alcohol use after multivariate analysis. We would like to encourage the readers to consult a statistician for these methods.

TRIVIA: The singular for “data” is “datum,” just as “stratum” is the singular for “strata.” Thus, “ data were analyzed …,” “ data were collected …,” and “ data have been ….”

Clinical Record Forms

We have discussed designing of questionnaires and clinical record forms (CRFs) in detail in two modules. We shall just highlight the most important aspects in this part. The CRF is an important part of the research protocol. The CRF should include all the variables of interest in the study. Thus, it is important to make a list of all parameters of interest before working on the CRF. This can be done by a thorough review of literature and discussion with experts. Once the questionnaire/CRF has been designed, the researcher should pilot it and change according to the feedback from the participants and one's own experience while administering the questionnaire or recording data in the CRF. The CRF should use coded responses (for close-ended questions), this will help in data entry and analysis. If the researcher has developed a scale, the reliability and validity should be tested (methods have been discussed in earlier sections). The CRF can be paper based or computer based (it will depend on the resources).

It is very important to describe the ethics for the present study. It should not be restricted to “ The study will be evaluated by an Institutional Review Committee …” The researcher should demonstrate that s/he has understood the various ethical issues in the present study. The three core principles for ethics are: autonomy (the participants have a right to decide whether to participate in the study or opt out), beneficence/nonmaleficence (the study should not be harmful to participants and the risk–benefit ratio should be adequately understood and described), and justice (all the risks and benefits of the present study should be equally distributed).

The researcher should try to address these issues in the section of “Ethics.” Currently, the National Institutes of Health has proposed the following seven principles of “Ethics in Clinical Research:” social and clinical value, scientific validity, fair subject selection, favorable risk–benefit ratio, independent review, informed consent, and respect for potential and enrolled subjects. The Indian Council of Medical Research has also published guidelines to conduct biomedical research in India. We strongly encourage the readers to be familiar with these guidelines. Furthermore, the researchers should keep themselves updated with changes in these regulations. If it is a clinical trial, the researcher should also be familiar with Schedule Y and Consent form requirements for these types of clinical trials.

Concluding Remarks

This module has been designed as a comprehensive guide for a dermatologist to enable him/her to embark on the exciting journey of designing studies of almost any kind that can be thought to be of relevance to clinical dermatology. There has been a conscious attempt to customize the discussion on design and analysis keeping not only dermatology, but also Indian conditions in mind. However, the module can be of help to any medical doctor embarking on the path to medical research. As contributors, it is our ardent hope that this module might act as a catalyst of good-quality research in the field of dermatology and beyond in India and elsewhere.

Financial support and sponsorship

Conflicts of interest.

There are no conflicts of interest.

Bibliography

How to Write the Rationale for a Research Paper

• Research Process
• Peer Review

A research rationale answers the big SO WHAT? that every adviser, peer reviewer, and editor has in mind when they critique your work. A compelling research rationale increases the chances of your paper being published or your grant proposal being funded. In this article, we look at the purpose of a research rationale, its components and key characteristics, and how to create an effective research rationale.

Updated on September 19, 2022

The rationale for your research is the reason why you decided to conduct the study in the first place. The motivation for asking the question. The knowledge gap. This is often the most significant part of your publication. It justifies the study's purpose, novelty, and significance for science or society. It's a critical part of standard research articles as well as funding proposals.

Essentially, the research rationale answers the big SO WHAT? that every (good) adviser, peer reviewer, and editor has in mind when they critique your work.

A compelling research rationale increases the chances of your paper being published or your grant proposal being funded. In this article, we look at:

• the purpose of a research rationale
• its components and key characteristics
• how to create an effective research rationale

What is a research rationale?

Think of a research rationale as a set of reasons that explain why a study is necessary and important based on its background. It's also known as the justification of the study, rationale, or thesis statement.

Essentially, you want to convince your reader that you're not reciting what other people have already said and that your opinion hasn't appeared out of thin air. You've done the background reading and identified a knowledge gap that this rationale now explains.

A research rationale is usually written toward the end of the introduction. You'll see this section clearly in high-impact-factor international journals like Nature and Science. At the end of the introduction there's always a phrase that begins with something like, "here we show..." or "in this paper we show..." This text is part of a logical sequence of information, typically (but not necessarily) provided in this order:

Here's an example from a study by Cataldo et al. (2021) on the impact of social media on teenagers' lives.

Note how the research background, gap, rationale, and objectives logically blend into each other.

The authors chose to put the research aims before the rationale. This is not a problem though. They still achieve a logical sequence. This helps the reader follow their thinking and convinces them about their research's foundation.

Elements of a research rationale

We saw that the research rationale follows logically from the research background and literature review/observation and leads into your study's aims and objectives.

This might sound somewhat abstract. A helpful way to formulate a research rationale is to answer the question, “Why is this study necessary and important?”

Generally, that something has never been done before should not be your only motivation. Use it only If you can give the reader valid evidence why we should learn more about this specific phenomenon.

A well-written introduction covers three key elements:

• What's the background to the research?
• What has been done before (information relevant to this particular study, but NOT a literature review)?
• Research rationale

Now, let's see how you might answer the question.

1. This study complements scientific knowledge and understanding

Discuss the shortcomings of previous studies and explain how'll correct them. Your short review can identify:

• Methodological limitations . The methodology (research design, research approach or sampling) employed in previous works is somewhat flawed.

Example : Here , the authors claim that previous studies have failed to explore the role of apathy “as a predictor of functional decline in healthy older adults” (Burhan et al., 2021). At the same time, we know a lot about other age-related neuropsychiatric disorders, like depression.

Their study is necessary, then, “to increase our understanding of the cognitive, clinical, and neural correlates of apathy and deconstruct its underlying mechanisms.” (Burhan et al., 2021).

• Contextual limitations . External factors have changed and this has minimized or removed the relevance of previous research.

Example : You want to do an empirical study to evaluate the effects of the COVID-19 pandemic on the number of tourists visiting Sicily. Previous studies might have measured tourism determinants in Sicily, but they preceded COVID-19.

• Conceptual limitations . Previous studies are too bound to a specific ideology or a theoretical framework.

Example : The work of English novelist E. M. Forster has been extensively researched for its social, political, and aesthetic dimensions. After the 1990s, younger scholars wanted to read his novels as an example of gay fiction. They justified the need to do so based on previous studies' reliance on homophobic ideology.

This kind of rationale is most common in basic/theoretical research.

2. This study can help solve a specific problem

Here, you base your rationale on a process that has a problem or is not satisfactory.

For example, patients complain about low-quality hospital care on weekends (staff shortages, inadequate attention, etc.). No one has looked into this (there is a lack of data). So, you explore if the reported problems are true and what can be done to address them. This is a knowledge gap.

Or you set out to explore a specific practice. You might want to study the pros and cons of several entry strategies into the Japanese food market.

It's vital to explain the problem in detail and stress the practical benefits of its solution. In the first example, the practical implications are recommendations to improve healthcare provision.

In the second example, the impact of your research is to inform the decision-making of businesses wanting to enter the Japanese food market.

This kind of rationale is more common in applied/practical research.

3. You're the best person to conduct this study

It's a bonus if you can show that you're uniquely positioned to deliver this study, especially if you're writing a funding proposal .

For an anthropologist wanting to explore gender norms in Ethiopia, this could be that they speak Amharic (Ethiopia's official language) and have already lived in the country for a few years (ethnographic experience).

Or if you want to conduct an interdisciplinary research project, consider partnering up with collaborators whose expertise complements your own. Scientists from different fields might bring different skills and a fresh perspective or have access to the latest tech and equipment. Teaming up with reputable collaborators justifies the need for a study by increasing its credibility and likely impact.

When is the research rationale written?

You can write your research rationale before, or after, conducting the study.

In the first case, when you might have a new research idea, and you're applying for funding to implement it.

Or you're preparing a call for papers for a journal special issue or a conference. Here , for instance, the authors seek to collect studies on the impact of apathy on age-related neuropsychiatric disorders.

In the second case, you have completed the study and are writing a research paper for publication. Looking back, you explain why you did the study in question and how it worked out.

Although the research rationale is part of the introduction, it's best to write it at the end. Stand back from your study and look at it in the big picture. At this point, it's easier to convince your reader why your study was both necessary and important.

How long should a research rationale be?

The length of the research rationale is not fixed. Ideally, this will be determined by the guidelines (of your journal, sponsor etc.).

The prestigious journal Nature , for instance, calls for articles to be no more than 6 or 8 pages, depending on the content. The introduction should be around 200 words, and, as mentioned, two to three sentences serve as a brief account of the background and rationale of the study, and come at the end of the introduction.

If you're not provided guidelines, consider these factors:

• Research document : In a thesis or book-length study, the research rationale will be longer than in a journal article. For example, the background and rationale of this book exploring the collective memory of World War I cover more than ten pages.
• Research question : Research into a new sub-field may call for a longer or more detailed justification than a study that plugs a gap in literature.

Which verb tenses to use in the research rationale?

It's best to use the present tense. Though in a research proposal, the research rationale is likely written in the future tense, as you're describing the intended or expected outcomes of the research project (the gaps it will fill, the problems it will solve).

Example of a research rationale

Research question : What are the teachers' perceptions of how a sense of European identity is developed and what underlies such perceptions?

Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology , 3(2), 77-101.

Burhan, A.M., Yang, J., & Inagawa, T. (2021). Impact of apathy on aging and age-related neuropsychiatric disorders. Research Topic. Frontiers in Psychiatry

Cataldo, I., Lepri, B., Neoh, M. J. Y., & Esposito, G. (2021). Social media usage and development of psychiatric disorders in childhood and adolescence: A review. Frontiers in Psychiatry , 11.

CiCe Jean Monnet Network (2017). Guidelines for citizenship education in school: Identities and European citizenship children's identity and citizenship in Europe.

Cohen, l, Manion, L., & Morrison, K. (2018). Research methods in education . Eighth edition. London: Routledge.

de Prat, R. C. (2013). Euroscepticism, Europhobia and Eurocriticism: The radical parties of the right and left “vis-à-vis” the European Union P.I.E-Peter Lang S.A., Éditions Scientifiques Internationales.

European Commission. (2017). Eurydice Brief: Citizenship education at school in Europe.

Polyakova, A., & Fligstein, N. (2016). Is European integration causing Europe to become more nationalist? Evidence from the 2007–9 financial crisis. Journal of European Public Policy , 23(1), 60-83.

Winter, J. (2014). Sites of Memory, Sites of Mourning: The Great War in European Cultural History . Cambridge: Cambridge University Press.

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Research proposal, thesis, exegesis, and journal article writing for business, social science and humanities (BSSH) research degree candidates

Topic outline, introduction and research justification.

Introduction and research justification, business, social sciences, humanities

Introduction.

• Signalling the topic in the first sentence
• The research justification or 'problem' statement 
• The 'field' of literature
• Summary of contrasting areas of research
• Summary of the 'gap' in the literature
• Research aims and objectives

Summary of the research design

Example research proposal introductions.

This topic outlines the steps in the introduction of the research proposal. As discussed in the first topic in this series of web resources, there are three key elements or conceptual steps within the main body of the research proposal. In this resource, these elements are referred to as the research justification, the literature review and the research design. These three steps also structure, typically, but not always in this order, the proposal introduction which contains an outline of the proposed research.

These steps pertain to the key questions of reviewers:

• What problem or issue does the research address? (research justification)
• How will the research contribute to existing knowledge? (the 'gap' in the literature, sometimes referred to as the research 'significance')
• How will the research achieve its stated objectives? (the research design)

Reviewers look to find a summary of the case for the research in the introduction, which, in essence, involves providing summary answers to each of the questions above.

The introduction of the research proposal usually includes the following content:

• a research justification or statement of a problem (which also serves to introduce the topic)
• a summary of the key point in the literature review (a summary of what is known and how the research aims to contribute to what is known)
• the research aim or objective
• a summary of the research design
• concise definitions of any contested or specialised terms that will be used throughout the proposal (provided the first time the term is used).

This topic will consider how to write about each of these in turn.

Signaling the topic in the first sentence

The first task of the research proposal is to signal the area of the research or 'topic' so the reader knows what subject will be discussed in the proposal. This step is ideally accomplished in the opening sentence or the opening paragraph of the research proposal. It is also indicated in the title of the research proposal. It is important not to provide tangential information in the opening sentence or title because this may mislead the reader about the core subject of the proposal.

A ‘topic’ includes:

• the context or properties of the subject (the particular aspect or properties of the subject that are of interest).

Questions to consider in helping to clarify the topic:

• What is the focus of my research?
• What do I want to understand?
• What domain/s of activity does it pertain to?
• What will I investigate in order to shed light on my focus?

The research justification or the ‘problem’ statement

The goal of the first step of the research proposal is to get your audience's attention; to show them why your research matters, and to make them want to know more about your research. The first step within the research proposal is sometimes referred to as the research justification or the statement of the 'problem'. This step involves providing the reader with critical background or contextual information that introduces the topic area, and indicates why the research is important. Research proposals often open by outlining a central concern, issue, question or conundrum to which the research relates.

The research justification should be provided in an accessible and direct manner in the introductory section of the research proposal. The number of words required to complete this first conceptual step will vary widely depending on the project.

Writing about the research justification, like writing about the literature and your research design, is a creative process involving careful decision making on your part. The research justification should lead up to the topic of your research and frame your research, and, when you write your thesis, exegesis or journal article conclusion, you will again return to the research justification to wrap up the implications of your research. That is to say, your conclusions will refer back to the problem and reflect on what the findings suggest about how we should treat the problem. For this reason, you may find the need to go back and reframe your research justification as your research and writing progresses.

The most common way of establishing the importance of the research is to refer to a real world problem. Research may aim to produce knowledge that will ultimately be used to:

• advance national and organisational goals (health, clean environment, quality education),
• improve policies and regulations,
• manage risk,
• contribute to economic development,
• promote peace and prosperity,
• promote democracy,
• test assumptions (theoretical, popular, policy) about human behaviour, the economy, society,
• understand human behaviour, the economy and social experience,
• understand or critique social processes and values.

Examples of 'research problems' in opening sentences and paragraphs of research writing

Management The concept of meritocracy is one replicated and sustained in much discourse around organisational recruitment, retention and promotion. Women have a firm belief in the concept of merit, believing that hard work, education and talent will in the end be rewarded (McNamee and Miller, 2004). This belief in workplace meritocracy could in part be due to the advertising efforts of employers themselves, who, since the early 1990s, attempt to attract employees through intensive branding programs and aggressive advertising which emphasise equality of opportunity. The statistics, however, are less than convincing, with 2008 data from the Equal Employment for Women in the Workplace agency signalling that women are disproportionately represented in senior management levels compared to men, and that the numbers of women at Chief Executive Officer level in corporate Australia have actually decreased (Equal Opportunity for Women Agency, 2008). Women, it seems, are still unable to shatter the glass ceiling and are consistently overlooked at executive level.

Psychology Tension-type headache is extremely prevalent and is associated with significant personal and social costs.

Education One of the major challenges of higher education health programs is developing the cognitive abilities that will assist undergraduate students' clinical decision making. This is achieved by stimulating enquiry analysis, creating independent judgement and developing cognitive skills that are in line with graduate practice (Hollingworth and McLoughlin 2001; Bedard, 1996).

Visual arts In the East, the traditional idea of the body was not as something separate from the mind. In the West, however, the body is still perceived as separate, as a counterpart of the mind. The body is increasingly at the centre of the changing cultural environment, particularly the increasingly visual culture exemplified by the ubiquity of the image, the emergence of virtual reality, voyeurism and surveillance culture. Within the contemporary visual environment, the body's segregation from the mind has become more intense than ever, conferring upon the body a 'being watched' or 'manufacturable' status, further undermining the sense of the body as an integral part of our being.

Literature review summary

The next step following the research justification in the introduction is the literature review summary statement. This part of the introduction summarises the literature review section of the research proposal, providing a concise statement that signals the field of research and the rationale for the research question or aim.

It can be helpful to think about the literature review element as comprised of four parts. The first is a reference to the field or discipline the research will contribute to. The second is a summary of the main questions, approaches or accepted conclusions in your topic area in the field or discipline at present ('what is known'). This summary of existing research acts as a contrast to highlight the significance of the third part, your statement of a 'gap'. The fourth part rephrases this 'gap' in the form of a research question, aim, objective or hypothesis.

For example

Scholars writing about ... (the problem area) in the field of ... (discipline or sub-discipline, part one) have observed that ... ('what is known', part two). Others describe ... ('what is known', part two). A more recent perspective chronicles changes that, in broad outline, parallel those that have occurred in ... ('what is known', part two). This study differs from these approaches in that it considers ... ('gap', research focus, part three). This research draws on ... to consider ... (research objective, part four).  

More information about writing these four parts of the literature review summary is provided below.

1. The 'field' of literature

The field of research is the academic discipline within which your research is situated, and to which it will contribute. Some fields grow out of a single discipline, others are multidisciplinary. The field or discipline is linked to university courses and research, academic journals, conferences and other academic associations, and some book publishers. It also describes the expertise of thesis supervisors and examiners. 

The discipline defines the kinds of approaches, theories, methods and styles of writing adopted by scholars and researchers working within them.

For a list of academic disciplines have a look at the wikipedia site at: https://en.wikipedia.org/wiki/List_of_academic_disciplines

The field or discipline is not the same as the topic of the research. The topic is the subject matter or foci of your research. Disciplines or 'fields' refer to globally recognised areas of research and scholarship.

The field or discipline the research aims to contribute to can be signalled in a few key words within the literature review summary, or possibly earlier withn the research justification.

Sentence stems to signal the field of research 

• Within the field of ... there is now agreement that ... .
• The field of ... is marked by ongoing debate about ... .
• Following analysis of ... the field of ... turned to an exploration of ... .

2. A summary of contrasting areas of research or what is 'known'

The newness or significance of what you are doing is typically established in a contrast or dialogue with other research and scholarship. The 'gap' (or hole in the donut) only becomes apparent by the surrounding literature (or donut). Sometimes a contrast is provided to show that you are working in a different area to what has been done before, or to show that you are building on previous work, or perhaps working on an unresolved issue within a discipline. It might also be that the approaches of other disciplines on the same problem area or focus are introduced to highlight a new angle on the topic.

3. The summary of the 'gap' in the literature

The 'gap' in the field typically refers to the explanation provided to support the research question. Questions or objectives grow out of areas of uncertainty, or gaps, in the field of research. In most cases, you will not know what the gap in knowledge is until you have reviewed the literature and written up a good part of the literature review section of the proposal. It is often not possible therefore to confidently write the 'gap' statement until you have done considerable work on the literature review. Once your literature review section is sufficiently developed, you can summarise the missing piece of knowledge in a brief statement in the introduction.

Sentence stems for summarising a 'gap' in the literature

Indicate a gap in the previous research by raising a question about it, or extending previous knowledge in some way:

• However, there is little information/attention/work/data/research on … .
• However, few studies/investigations/researchers/attempt to … .

Often steps two and three blend together in the same sentence, as in the sentence stems below.

Sentence stems which both introduce research in the field (what is 'known') and summarise a 'gap'

• The research has tended to focus on …(introduce existing field foci), rather than on … ('gap').
• These studies have emphasised that … …(introduce what is known), but it remains unclear whether … ('gap').
• Although considerable research has been devoted to … (introduce field areas), rather less attention has been paid to … ('gap').

The 'significance' of the research

When writing the research proposal, it is useful to think about the research justification and the  ‘gap in the literature’ as two distinct conceptual elements, each of which must be established separately. Stating a real world problem or outlining a conceptual or other conundrum or concern is typically not, in itself, enough to justify the research. Similarly, establishing that there is a gap in the literature is often not enough on its own to persuade the reader that the research is important. In the first case, reviewers may still wonder ‘perhaps the problem or concern has already been addressed in the literature’, or, in the second, ‘so little has been done on this focus, but perhaps the proposed research is not important’? The proposal will ideally establish that the research is important, and that it will provide something new to the field of knowledge.

In effect, the research justification and the literature review work together to establish the benefit, contribution or 'significance' of the research. The 'significance' of the research is established not in a statement to be incorporated into the proposal, but as something the first two sections of the proposal work to establish. Research is significant when it pertains to something important, and when it provides new knowledge or insights within a field of knowledge.

4. The research aim or objective

The research aim is usually expressed as a concise statement at the close of the literature review. It may be referred to as an objective, a question or an aim. These terms are often used interchangeably to refer to the focus of the investigation. The research focus is the question at the heart of the research, designed to produce new knowledge. To avoid confusing the reader about the purpose of the research it is best to express it as either an aim, or an objective, or a question. It is also important to frame the aims of the research in a succinct manner; no more than three dot points say. And the aim/objective/question should be framed in more or less the same way wherever it appears in the proposal. This ensures the research focus is clear.

Language use

Research generally aims to produce knowledge, as opposed to say recommendations, policy or social change. Research may support policy or social change, and eventually produce it in some of its applications, but it does not typically produce it (with the possible exception of action research). For this reason, aims and objectives are framed in terms of knowledge production, using phrases like:

• to increase understanding, insight, clarity;
• to evaluate and critique;
• to test models, theory, or strategies.

These are all knowledge outcomes that can be achieved within the research process.

Reflecting your social philosophy in the research aim

A well written research aim typically carries within it information about the philosophical approach the research will take, even if the researcher is not themselves aware of it, or if the proposal does not discuss philosophy or social theory at any length. If you are interested in social theory, you might consider framing your aim such that it reflects your philosophical or theoretical approach. Since your philosophical approach reflects your beliefs about how 'valid' knowledge can be gained, and therefore the types of questions you ask, it follows that it will be evident within your statement of the research aim. Researchers, variously, hold that knowledge of the world arises through:

• observations of phenomena (measurements of what we can see, hear, taste, touch);
• the interactions between interpreting human subjects and objective phenomena in the world;
• ideology shaped by power, which we may be unconscious of, and which must be interrogated and replaced with knowledge that reflects people's true interests; 
• the structure of language and of the unconscious;
• the play of historical relations between human actions, institutional practices and prevailing discourses;
• metaphoric and other linguistic relations established within language and text.

The philosophical perspective underpinning your research is then reflected in the research aim. For example, depending upon your philosophical perspective, you may aim to find out about:

• observable phenomenon or facts;
• shared cultural meanings of practices, rituals, events that determine how objective phenomena are interpreted and experienced;
• social structures and political ideologies that shape experience and distort authentic or empowered experience;
• the structure of language;
• the historical evolution of networks of discursive and extra-discursive practices;
• emerging or actual phenomenon untainted by existing representation.

You might check your aim statement to ensure it reflects the philosophical perspective you claim to adopt in your proposal. Check that there are not contradictions in your philosophical claims and that you are consistent in your approach. For assistance with this you may find the Social philosophy of research resources helpful.

Sentence stems for aims and objectives

• The purpose of this research project is to … .
• The purpose of this investigation is to … .
• The aim of this research project is to … .
• This study is designed to … .

The next step or key element in the research proposal is the research design. The research design explains how the research aims will be achieved. Within the introduction a summary of the overall research design can make the project more accessible to the reader.

The summary statement of the research design within the introduction might include:

• the method/s that will be used (interviews, surveys, video observation, diary recording);
• if the research will be phased, how many phases, and what methods will be used in each phase;
• brief reference to how the data will be analysed.

The statement of the research design is often the last thing discussed in the research proposal introduction.

NB. It is not necessary to explain that a literature review and a detailed ouline of the methods and methodology will follow because academic readers will assume this.

Title: Aboriginal cultural values and economic sustainability: A case study of agro-forestry in a remote Aboriginal community

Further examples can be found at the end of this topic, and in the drop down for this topic in the left menu. 

In summary, the introduction contains a problem statement, or explanation of why the research is important to the world, a summary of the literature review, and a summary of the research design. The introduction enables the reviewer, as well as yourself and your supervisory team, to assess the logical connections between the research justification, the 'gap' in the literature, research aim and the research design without getting lost in the detail of the project. In this sense, the introduction serves as a kind of map or abstract of the proposed research as well as of the main body of the research proposal.

The following questions may be useful in assessing your research proposal introduction.

• Have I clearly signalled the research topic in the key words and phrases used in the first sentence and title of the research proposal?
• Have I explained why my research matters, the problem or issue that underlies the research in the opening sentences,  paragraphs and page/s?
• Have I used literature, examples or other evidence to substantiate my understanding of the key issues?
• Have I explained the problem in a way that grabs the reader’s attention and concern?
• Have I indicated the field/s within which my research is situated using key words that are recognised by other scholars?
• Have I provided a summary of previous research and outlined a 'gap' in the literature?
• Have I provided a succinct statement of the objectives or aims of my research?
• Have I provided a summary of the research phases and methods?

This resource was developed by Wendy Bastalich.

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How to Write Justification of the Study in Research

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The justification of the study is also referred to as the rationale for the study . It is what inspired you to research a given topic. As students, it is very important to know that research writing is not just one of the things we do for leisure, research is a vital part of human endeavour, it is through research done in the past that a lot of improvements are seen today around the world. Research should be able to fill a gap and provide solutions to an existing problem, hence researchers must do due diligence in identifying the reasons for starting a research work and be able to justify their reasons for embarking on a research journey.

If a research project is to be carried out on “Introduction of Digital Libraries for Students in Nigeria Senior Secondary Schools” it is expected that the researcher has found some setbacks in the study pattern of students or the limitations of using the physical libraries on campus.

The researcher must be able to give the reasons behind his choice of research topic, the importance of digital library should outweigh the challenges it poses.

The researcher should be able to justify the reasons for selecting a chosen project topic and discuss why the research study is needed.

For research to be justified, four main criteria must be discussed to convince the supervisor or readers that a study is worthy of undertaking.

• The size or area involved in the study should be discussed, the researcher needs to show the geographical area or locations that the research would cover and provide reasons for the choice of area and what the outcome of the study will do for such area.
• The research gaps found in previous literature of similar studies should be discussed. The researcher must show the missing piece from other literature that needs to be bridged and the reasons for the endeavour. The importance of filling research gaps should be told including the necessary contributions to the body of knowledge that the study would project at the end of the investigations and findings.
• The researcher should be able to justice that there has been an improved methodology or the processes of carrying out the type of research undertaken and should show how the study intends to incorporate the enhanced methods of carrying out research in the selected field or subject to investigate.
• The researcher should discuss the main benefits of the research to the general public, profession, group, institutions, the government policies and practices in the concerned field of study and how these benefits will enable future researchers and authors to make or develop future theories, literature and additional inputs in the coming days.

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Peer-reviewed

Research Article

Justification of research using systematic reviews continues to be inconsistent in clinical health science—A systematic review and meta-analysis of meta-research studies

Roles Conceptualization, Data curation, Methodology, Project administration, Writing – original draft, Writing – review & editing

* E-mail: [email protected]

Affiliation Department of Physiotherapy and Occupational Therapy, Aalborg University Hospital, Denmark and Public Health and Epidemiology Group, Department of Health, Science and Technology, Aalborg University, Aalborg, Denmark

Roles Conceptualization, Data curation, Methodology, Writing – review & editing

Affiliation Department of Public Health, University of Southern Denmark Odense, Denmark

Roles Conceptualization, Data curation, Formal analysis, Methodology, Writing – review & editing

Affiliation Department of Sports Science and Clinical Biomechanics, University of Southern Denmark and Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Herlev and Gentofte, Herlev, Denmark

Roles Conceptualization, Methodology, Writing – review & editing

Affiliation M. Louise Fitzpatrick College of Nursing, Villanova University, Villanova, PA, United States of America

Affiliation Digital Content Services, Elsevier, London, United Kingdom

Affiliation Johns Hopkins University School of Medicine, Baltimore, MD, United States of America

Roles Conceptualization, Data curation, Methodology, Project administration, Supervision, Writing – review & editing

Affiliation Department of Evidence-Based Practice, Western Norway University of Applied Sciences, Bergen, Norway

• Jane Andreasen, 
• Birgitte Nørgaard, 
• Eva Draborg, 
• Carsten Bogh Juhl, 
• Jennifer Yost, 
• Klara Brunnhuber, 
• Karen A. Robinson, 

• Published: October 31, 2022
• https://doi.org/10.1371/journal.pone.0276955
• Peer Review
• Reader Comments

Redundancy is an unethical, unscientific, and costly challenge in clinical health research. There is a high risk of redundancy when existing evidence is not used to justify the research question when a new study is initiated. Therefore, the aim of this study was to synthesize meta-research studies evaluating if and how authors of clinical health research studies use systematic reviews when initiating a new study.

Seven electronic bibliographic databases were searched (final search June 2021). Meta-research studies assessing the use of systematic reviews when justifying new clinical health studies were included. Screening and data extraction were performed by two reviewers independently. The primary outcome was defined as the percentage of original studies within the included meta-research studies using systematic reviews of previous studies to justify a new study. Results were synthesized narratively and quantitatively using a random-effects meta-analysis. The protocol has been registered in Open Science Framework ( https://osf.io/nw7ch/ ).

Twenty-one meta-research studies were included, representing 3,621 original studies or protocols. Nineteen of the 21 studies were included in the meta-analysis. The included studies represented different disciplines and exhibited wide variability both in how the use of previous systematic reviews was assessed, and in how this was reported. The use of systematic reviews to justify new studies varied from 16% to 87%. The mean percentage of original studies using systematic reviews to justify their study was 42% (95% CI: 36% to 48%).

Justification of new studies in clinical health research using systematic reviews is highly variable, and fewer than half of new clinical studies in health science were justified using a systematic review. Research redundancy is a challenge for clinical health researchers, as well as for funders, ethics committees, and journals.

Citation: Andreasen J, Nørgaard B, Draborg E, Juhl CB, Yost J, Brunnhuber K, et al. (2022) Justification of research using systematic reviews continues to be inconsistent in clinical health science—A systematic review and meta-analysis of meta-research studies. PLoS ONE 17(10): e0276955. https://doi.org/10.1371/journal.pone.0276955

Editor: Andrzej Grzybowski, University of Warmia, POLAND

Received: January 24, 2022; Accepted: October 18, 2022; Published: October 31, 2022

Copyright: © 2022 Andreasen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: All relevant data are within the paper and its Supporting Information files.

Funding: The authors received no specific funding for this work.

Competing interests: The authors have declared that no competing interests exist.

Introduction

Research redundancy in clinical health research is an unethical, unscientific, and costly challenge that can be minimized by using an evidence-based research approach. First introduced in 2009 and since endorsed and promoted by organizations and researchers worldwide [ 1 – 6 ], evidence-based research is an approach whereby researchers systematically and transparently take into account the existing evidence on a topic before embarking on a new study. The researcher thus strives to enter the project unbiased, or at least aware of the risk of knowledge redundancy bias. The key is an evidence synthesis using formal, explicit, and rigorous methods to bring together the findings of pre-existing research to synthesize the totality what is known [ 7 ]. Evidence syntheses provide the basis for an unbiased justification of the proposed research study to ensure that the enrolling of participants, resource allocation, and healthcare systems are supporting only relevant and justified research. Enormous numbers of research studies are conducted, funded, and published globally every year [ 8 ]. Thus, if earlier relevant research is not considered in a systematic and transparent way when justifying research, the foundation for a research question is not properly established, thereby increasing the risk of redundant studies being conducted, funded, and published resulting in a waste of resources, such as time and funding [ 1 , 4 ]. Most importantly, when redundant research is initiated, participants unethically and unnecessarily receive placebos or receive suboptimal treatment.

Previous meta-research, defined as the study of research itself including the methods, reporting, reproducibility, evaluation and incentives of the research [ 9 ] have shown that there is considerable variation and bias in the use of evidence syntheses to justify research studies [ 10 – 12 ]. To the best of our knowledge, a systematic review of previous meta-research studies assessing the use of systematic reviews to justify studies in clinical health research has not previously been conducted. Evaluating how evidence-based research is implemented in research practices across disciplines and specialties when justifying new studies will provide an indication of the integration of evidence-based research in research practices [ 9 ]. The present systematic review aimed to identify and synthesize results from meta-research studies, regardless of study type, evaluating if and how authors of clinical health research studies use systematic reviews to justify a new study.

Prior to commencing the review, we registered the protocol in the Open Science Framework ( https://osf.io/nw7ch/ ). The protocol remained unchanged, but in this paper we have made adjustments to the risk-of-bias assessment, reducing the tool to 10 items and removing the assessment of reporting quality. The review is presented in accordance with the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) guidelines [ 13 ].

Eligibility criteria

Studies were eligible for inclusion if they were original meta-research studies, regardless of study type, that evaluated if and how authors of clinical health research studies used systematic reviews to justify new clinical health studies. No limitations on language, publication status, or publication year were applied. Only meta-research studies of studies on human subjects in clinical health sciences were eligible for inclusion. The primary outcome was defined as the percentage of original studies within the included meta-research studies using systematic reviews of previous studies to justify a new study. The secondary outcome was how the systematic reviews of previous research were used (e.g., within the text to justify the study) by the original studies.

Information sources and search strategy

This study is one of six ongoing evidence syntheses (four systematic reviews and two scoping reviews) planned to assess the global state of evidence-based research in clinical health research. These are; a scoping review mapping the area broadly to describe current practice and identify knowledge gaps, a systematic review on the use of prior research in reports of randomized controlled trials specifically, three systematic reviews assessing the use of systematic reviews when justifying, designing [ 14 ] or putting results of a new study in context, and finally a scoping review uncovering the breadth and characteristics of the available, empirical evidence on the topic of citation bias. Further, the research group is working with colleagues on a Handbook for Evidence-based Research in health sciences. Due to the common aim across the six evidence syntheses, a broad overall search strategy was designed to identify meta-research studies that assessed whether researchers used earlier similar studies and/or systematic reviews of earlier similar studies to inform the justification and/or design of a new study, whether researchers used systematic reviews to inform the interpretation of new results, and meta-research studies that assessed if there were published redundant studies within a specific area or not.

The first search was performed in June 2015. Databases included MEDLINE via both PubMed and Ovid, EMBASE via Ovid, CINAHL via EBSCO, Web of Science (Science Citation Index Expanded (SCI-EXPANDED), Social Sciences Citation Index (SSCI), Arts & Humanities Citation Index (A&HCI), and the Cochrane Methodology Register (CMR, Methods Studies) from inception (Appendix 1 in S1 File ). In addition, reference lists of included studies were screened for relevant articles, as well as the authors’ relevant publications and abstracts from the Cochrane Methodology Reviews.

Based upon the experiences from the results of the baseline search in June 2015, an updated and revised search strategy was conducted in MEDLINE and Embase via Ovid from January 2015 to June 2021 (Appendix 1 in S1 File ). Once again, the reference lists of new included studies were screened for relevant references, as were abstracts from January 2015 to June 2021 in the Cochrane Methodology Reviews. Experts in the field were contacted to identify any additional published and/or grey literature. No restrictions were made on publication year and language. See Appendix 1 and Appendix 2 in S1 File for the full search strategy.

Screening and study selection

Following deduplication, the search results were uploaded to Rayyan ( https://rayyan.qcri.org/welcome ). The search results from the 1st search (June 2015) were independently screened by a pair of reviewers. Twenty screeners were paired, with each pair including an author very experienced in systematic reviews and a less experienced author. To increase consistency among reviewers, both reviewers initially screened the same 50 publications and discussed the results before beginning screening for this review. Disagreements on study selection were resolved by consensus and discussion with a third reviewer, if needed. The full-text screening was also performed by two reviewers independently. Disagreements on study selection were resolved by consensus and discussion. There were also two independent reviewers who screened following the last search, using the same procedure, as for the first search, for full-text screening and disagreements. The screening procedures resulted in a full list of studies potentially relevant for one or more of the six above-mentioned evidence syntheses.

A second title and abstract screening and full-text screening of the full list was then performed independently by two reviewers using screening criteria specific to this systematic review. Reasons for excluding trials were recorded, and disagreements between the reviewers were resolved through discussion. If consensus was not reached, a third reviewer was involved.

Data extraction

We developed and pilot tested a data extraction form to extract data regarding study characteristics and outcomes of interest. Two reviewers independently extracted data, with other reviewers available to resolve disagreements. The following study characteristics were extracted from each of the included studies: bibliographic information, study aim, study design, setting, country, inclusion period, area of interest, results, and conclusion. Further, data for this study’s primary and secondary outcomes were extracted; these included the percentage of original studies using systematic reviews to justify their study and how the systematic reviews of previous research were used (e.g., within the text to justify the study) by the original studies.

Risk-of-bias assessment

No standard tool was identified to assess the risk of bias in empirical meta-research studies. The Editorial Group of the Evidence-Based Research Network prepared a risk-of-bias tool for the planned five systematic reviews with list of items important for evaluating the risk of bias in meta-research studies. For each item, one could classify the study under examination as exhibiting a “low risk of bias”, “unclear risk of bias” or “high risk of bias”. We independently tested the list of items upon a sample of included studies. Following a discussion of the different answers, we adjusted the number and content of the list of items to ten and defined the criteria to evaluate the risk of bias in the included studies ( Table 1 ). Each of the included meta-research studies was appraised independently by two reviewers using the customized checklist to determine the risk of bias. Disagreements regarding the risk of bias were solved through discussion. No study was excluded on the grounds of low quality.

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https://doi.org/10.1371/journal.pone.0276955.t001

Data synthesis and interpretation

In addition, to narratively summarizing the characteristics of the included meta-research studies and their risk-of-bias assessments, the percentage of original studies using systematic review of previous similar studies to justify a new study (primary outcome) was calculated as the number of studies using at least one systematic review, divided by the total number of original studies within each of the included meta-research studies. A meta-analysis using the random-effects model (DerSimonian and Laird) was used to estimate the overall estimate and perform the forest plot as this model is the default when using the metaprop command. Heterogeneity was evaluated estimating the I 2 statistics (the percentage of variance attributable to heterogeneity i.e., inconsistency) and the between study variance tau 2 . When investigating reasons for heterogeneity, a restricted maximum likelihood (REML) model was used and covariates with the ability to reduce tau 2 was deemed relevant. [ 15 ].

All analyses were conducted in Stata, version 17.0 (StataCorp. 2019. Stata Statistical Software : Release 17 . College Station, TX: StataCorp LLC).

Study selection

In total, 30,592 publications were identified through the searches. Of these, 69 publications were determined eligible for one of the six evidence syntheses. A total of 21 meta-research studies fulfilled the inclusion criteria for this systematic review [ 10 , 11 , 16 – 34 ]; see Fig 1 .

https://doi.org/10.1371/journal.pone.0276955.g001

Study characteristics

The 21 included meta-research studies were published from 2007 to 2021, representing 3,621 original studies or protocols and one survey with 106 participants; only three of these studies were published before 2013 [ 10 , 18 , 26 ]. The sample of the original study within each of the included meta-research studies varied. One meta-research study surveyed congress delegates [ 29 ], one study examined first-submission protocols for randomized controlled trials submitted to four hospital ethics committees [ 17 ], and 14 studies examined randomized or quasi-randomized primary studies published during a specific time period in a range of journals [ 10 , 11 , 18 , 21 – 28 , 31 , 32 , 34 ] or in specific databases [ 16 , 19 , 20 , 30 ]. Finally, one study examined the use of previously published systematic reviews when publishing a new systematic review [ 33 ]. Further, the number of original studies within each included meta-research study varied considerably, ranging from 18 [ 10 ] to 637 original studies [ 27 ]. The characteristics of the included meta-research studies are presented in Table 2 .

https://doi.org/10.1371/journal.pone.0276955.t002

Risk of bias assessment

Overall, most studies were determined to exhibit a low risk of bias in the majority of items, and all of the included meta-research studies reported an unambiguous aim and a match between aim and methods. However, only a few studies provided argumentation for their choice of data source [ 17 , 20 , 24 , 30 ], and only two of the 21 studies referred to an available a-priori protocol [ 16 , 21 ]. Finally, seven studies provided poor or no discussion of the limitations of their study [ 10 , 19 , 22 , 26 – 28 , 34 ]. The risk-of-bias assessments are shown in Table 3 .

https://doi.org/10.1371/journal.pone.0276955.t003

Synthesis of results

Of the included 21 studies, a total of 18 studies were included in the meta-analysis. Two studies included two cohorts each, and both cohorts in each of these studies were included in our meta-analysis [ 21 , 30 ]. The survey by Clayton and colleagues, with a response rate of 17%, was not included in the meta-analysis as the survey did not provide data to identify the use of systematic reviews to justify specific studies. However, their results showed that 42 of 84 respondents (50%) reported using a systematic review for justification [ 29 ]. The study by Chow, which was also not included in the meta-analysis, showed that justification varied largely within and between specialties. However, only relative numbers were provided, and, therefore, no overall percentage could be extracted [ 11 ]. The study by Seehra et al. counted the SR citations in RCTs and not the number of RCTs citing SRs and is therefore not included in the meta-analysis either [ 23 ].

The percentage of original studies that justified a new study with a systematic review within each meta-research study ranged from 16% to 87%. The pooled percentage of original studies using systematic reviews to justify their research question was 42% (95% CI: 36% to 48%) as shown in Fig 2 . Where the confidence interval showed the precision of the pooled estimate in a meta-analysis, the prediction interval showed the distribution of the individual studies. The heterogeneity in the meta-analysis assessed by I 2 was 94%. The clinical interpretation of this large heterogeneity is seen in a the very broad prediction interval ranging from 16 to 71%, meaning that based on these studies there is 95% chance that the results of the next study will show a prevalence between 16 to 71%.

Forest plot prevalence and 95% confidence intervals for the percentage of studies using an SR to justify the study.

https://doi.org/10.1371/journal.pone.0276955.g002

Further, we conducted an explorative subgroup analysis of the study of Helfer et al. and the study of Joseph et al. as these two studies were on meta-analyses and protocols and therefore differ from the other included studies. This analysis did only marginally change the pooled percentage to 39% (95% CI; 33% to 46%) and the between-study variance (tau 2 ) was reduced with 23%.

The 21 included studies varied greatly in their approach and in their description of how systematic reviews were used, i.e., if the original studies referred and whether the used systematic reviews in the original studies were relevant and/or of high-quality. Nine studies assessed, to varying degrees, whether the used systematic reviews were relevant for the justification of the research [ 16 – 20 , 25 , 30 , 32 , 34 ]. Overall, the information reported by the meta-research studies was not sufficient to report the percentage of primary studies referring to relevant systematic reviews. No details were provided regarding the methodological quality of the systematic reviews used to justify the research question or if they were recently published reviews, except for Hoderlein et al., who reported that the mean number of years from publication of the cited systematic review and the trial report was four years [ 30 ].

We identified 21 meta-research studies, spanning 15 publication years and 12 medical disciplines. The findings showed substantial variability in the use of systematic reviews when justifying new clinical studies, with the incidence of use ranging from 16% to 87%. However, fewer than half of the 19 meta-analysis-eligible studies used a systematic review to justify their new study. There was wide variability, and a general lack of information, about how systematic reviews were used within many of the original studies. Our systematic review found that the proportion of original studies justifying their new research using evidence syntheses is sub-optimal and, thus, the potential for research redundancy continues to be a challenge. This study corroborates the serious possible consequences regarding research redundancy previously problematized by Chalmers et al. and Glasziou et al. [ 35 , 36 ].

Systematic reviews are considered crucial when justifying a new study, as is emphasized in reporting guidelines such as the CONSORT statement [ 37 ]. However, there are challenges involved in implementing an evidence-based research approach. The authors of the included meta-research study reporting the highest use of systematic reviews to justify a new systematic review study point out that even though the authors of the original studies refer to some of the published systematic reviews, they neglect others on the same topic, which may be problematic and result in a biased approach [ 33 ]. Other issues that have been identified are the risk of research waste when a systematic review may not be methodologically sound [ 12 , 38 ] and that there is also redundancy in the conduct of systematic reviews, with many overlapping systematic reviews existing on the same topic [ 39 – 41 ]. In the original studies within the meta-research studies, the use of systematic reviews was not consistent and, further, it was not explicated whether the systematic reviews used were the most recent and/or of high methodological quality. These issues speak to the need for refinement in the area of systematic review development, such as mandatory registration in prospective registries. Only two out of the included 21 studies in this study referred to an available a-priori protocol [ 16 , 21 ]. General recommendations in the use of systematic reviews as justification for a new study are difficult as these will be topic specific, however researchers should be aware to use the most robust and methodologically sound of recently published reviews, preferably with á priori published protocols.

Efforts must continue in promoting the use of evidence-based research approaches among clinical health researchers and other important stakeholders, such as funders. Collaborations such as the Ensuring Value in Research Funders Forum, and changes in funding review criteria mandating reference to previously published systematic reviews when justifying the research question within funding proposals, are examples of how stakeholders can promote research that is evidence-based [ 8 , 41 ].

Strengths and limitations

We conducted a comprehensive and systematic search. The lack of standard terminology for meta-research studies resulted in search strategies that retrieved thousands of citations. We also relied on snowballing efforts to identify relevant studies, such as by contacting experts and scanning the reference lists of relevant studies.

There is also a lack of tools to assess risk of bias for meta-research studies, so a specific risk-of bias tool for the five conducted reviews was created. The tool was discussed and revised continuously throughout the research process; however, we acknowledge that the checklist is not yet optimal and a validated risk-of-bias tool for meta-research studies is needed.

Many of the included meta-research studies did not provide details as to whether the systematic reviews used to justify the included studies were relevant, high-quality and/or recently published. This may raise questions as to the validity of our findings, as the majority of the meta-research studies only provide an indication of the citation of systematic reviews to justify new studies, not whether the systematic review cited was relevant, recent and of high-quality, or even how the systematic review was used. We did not assess this further either. Nonetheless, even if we assumed that these elements were provided for every original study included in the included meta-research studies (i.e. taking a conservative approach), fewer than half used systematic reviews to justify their research questions. The conservative approach used in this study therefore does not underestimate, and perhaps rather overestimates, the actual use of relevant systematic reviews to justify studies in clinical health science across disciplines.

Different study designs were included in the meta-analysis, which may have contributed to the high degree of heterogeneity observed. Therefore, the presented results should be interpreted with caution due to the high heterogeneity. Not only were there differences in the methods of the included meta-research studies, but there was also heterogeneity in the medical specialties evaluated [ 42 , 43 ].

In conclusion, justification of research questions in clinical health research with systematic reviews continues to be inconsistent; fewer than half of the primary studies within the included meta-research studies in this systematic review were found to have used a systematic review to justify their research question. This indicates that the risk of redundant research is still high when new studies across disciplines and professions in clinical health are initiated, thereby indicating that evidence-based research has not yet been successfully implemented in the clinical health sciences. Efforts to raise awareness and to ensure an evidence-based research approach continue to be necessary, and such efforts should involve clinical health researchers themselves as well as important stakeholders such as funders.

Supporting information

S1 checklist..

https://doi.org/10.1371/journal.pone.0276955.s001

S1 Protocol.

https://doi.org/10.1371/journal.pone.0276955.s002

https://doi.org/10.1371/journal.pone.0276955.s003

https://doi.org/10.1371/journal.pone.0276955.s004

Acknowledgments

This work has been prepared as part of the Evidence-Based Research Network ( ebrnetwork.org ). The Evidence-Based Research Network is an international network that promotes the use of systematic reviews when justifying, designing, and interpreting research. The authors thank the Section for Evidence-Based Practice, Department for Health and Function, Western Norway University of Applied Sciences for their generous support of the EBRNetwork. Further, thanks to COST Association for supporting the COST Action “EVBRES” (CA 17117, evbres.eu) and thereby the preparation of this study. Thanks to Gunhild Austrheim, Head of Unit, Library at Western Norway University of Applied Sciences, Norway, for helping with the second search. Thanks to those helping with the screening: Durita Gunnarsson, Gorm Høj Jensen, Line Sjodsholm, Signe Versterre, Linda Baumbach, Karina Johansen, Rune Martens Andersen, and Thomas Aagaard.

We gratefully acknowledge the contribution from the EVBRES (COST ACTION CA 17117) Core Group, including Anne Gjerland (AG) and her specific contribution to the search and screening process.

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• 36. Https://blogs.bmj.com/bmj/2016/01/14/paul-glasziou-and-iain-chalmers-is-85-of-health-research-really-wasted/ ). No Title.

7 Examples of Justification (of a project or research)

The justification to the part of a research project that sets out the reasons that motivated the research. The justification is the section that explains the importance and the reasons that led the researcher to carry out the work.

The justification explains to the reader why and why the chosen topic was investigated. In general, the reasons that the researcher can give in a justification may be that his work allows to build or refute theories; bring a new approach or perspective on the subject; contribute to the solution of a specific problem (social, economic, environmental, etc.) that affects certain people; generate meaningful and reusable empirical data; clarify the causes and consequences of a specific phenomenon of interest; among other.

Among the criteria used to write a justification, the usefulness of the research for other academics or for other social sectors (public officials, companies, sectors of civil society), the significance in time that it may have, the contribution of new research tools or techniques, updating of existing knowledge, among others. Also, the language should be formal and descriptive.

Examples of justification

• This research will focus on studying the reproduction habits of salmon in the Mediterranean region of Europe, since due to recent ecological changes in the water and temperatures of the region produced by human economic activity , the behavior of these animals has been modified. Thus, the present work would allow to show the changes that the species has developed to adapt to the new circumstances of its ecosystem, and to deepen the theoretical knowledge about accelerated adaptation processes, in addition to offering a comprehensive look at the environmental damage caused by growth. unsustainable economic, helping to raise awareness of the local population.
• We therefore propose to investigate the evolution of the theoretical conceptions of class struggle and economic structure throughout the work of Antonio Gramsci, since we consider that previous analyzes have overlooked the fundamentally dynamic and unstable conception of human society that is present. in the works of Gramsci, and that is of vital importance to fully understand the author’s thought.
• The reasons that led us to investigate the effects of regular use of cell phones on the health of middle-class young people under 18 years of age are centered on the fact that this vulnerable sector of the population is exposed to a greater extent than the rest of society to risks that the continuous use of cell phone devices may imply, due to their cultural and social habits. We intend then to help alert about these dangers, as well as to generate knowledge that helps in the treatment of the effects produced by the abuse in the use of this technology.
• We believe that by means of a detailed analysis of the evolution of financial transactions carried out in the main stock exchanges of the world during the period 2005-2010, as well as the inquiry about how financial and banking agents perceived the situation of the financial system, it will allow us to clarify the economic mechanisms that enable the development of an economic crisis of global dimensions such as the one that the world experienced since 2009, and thus improve the design of regulatory and counter-cyclical public policies that favor the stability of the local and international financial system.
• Our study about the applications and programs developed through the three analyzed programming languages ​​(Java, C ++ and Haskell), can allow us to clearly distinguish the potential that each of these languages ​​(and similar languages) present for solving specific problems. , in a specific area of ​​activity. This would allow not only to increase efficiency in relation to long-term development projects, but to plan coding strategies with better results in projects that are already working, and to improve teaching plans for teaching programming and computer science.
• This in-depth study on the expansion of the Chinese empire under the Xia dynasty, will allow to clarify the socioeconomic, military and political processes that allowed the consolidation of one of the oldest states in history, and also understand the expansion of metallurgical and administrative technologies along the coastal region of the Pacific Ocean. The deep understanding of these phenomena will allow us to clarify this little-known period in Chinese history, which was of vital importance for the social transformations that the peoples of the region went through during the period.
• Research on the efficacy of captropil in the treatment of cardiovascular conditions (in particular hypertension and heart failure) will allow us to determine if angiotensin is of vital importance in the processes of blocking the protein peptidase, or if by the On the contrary, these effects can be attributed to other components present in the formula of drugs frequently prescribed to patients after medical consultation.

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