SQUARE-IT: a proposed approach to square the identified research problem in the literature with the objectives, the appropriate clinical research question, and the research hypothesis | BMC Medical Research Methodology

The item ‘Specific’ of the SQUARE-IT approach asks whether there is a specific, obvious, explicit, relevant and unambiguous research problem/gap in literature or clinical practice regarding the research topic. The identification of a clear and unambiguous problem to be investigated is a crucial step in establishing a research agenda [22]. The identified problem, which may be subject to challenge or improvement can arise from various source such as theory (that needs to be reevaluated regarding its validity or that may be novel), from existing facts (that may be represented by the current evidence), or from opinions (that may be advocated by experts of a certain clinical arena or methods) [16]. Researchers who seek to identify a specific research problem can explore research gaps within the conclusions of recent systematic reviews [22, 25, 33,34,35], qualitative and quantitative studies [24], or within their area of interest. Many studies explicitly highlight research gaps and recommend further research projects, including the appropriate study design, in their conclusions and outlook sections. Furthermore, researchers should be driven to uncover research gaps based on their clinical experience, necessitating an extensive literature search to confirm the potential existence of research gaps.

A way of moving from research ideas to a specific problem, and then to square the problem with the clinical question and hypothesis, is provided by Carter & Lubinsky [16] and includes the following sets, with examples or explanations, which are shown in Box 2.

In this process of specifying research ideas, researchers should first be creative enough to generate many ideas, and then selective enough to focus on a limited number of ideas for further study [16].

The item ‘Quantifiable’ assesses whether a research problem is well-defined, quantifiable, and can be verified through the selection of appropriate independent and dependent variables. Research studies should include all important and relevant independent variables. An accurate assessment of the variables should be performed to generate robust results [36]. Including just one independent variable may result in only a partial description of the dependent variable, which represents a research problem/gap to be identified and addressed by the researcher. Different independent variables should be combined with a dependent variable to avoid missing important explanations of the dependent variable. The outcome (dependent) variables are considered as measurable endpoints of the objectives that will be observed throughout the study [13]. The occurrence (or non-occurrence) of the outcomes reveals that the predefined objective has been achieved. The outcome variables should be derived from – and consistent with – the study objectives. Examples of defining independent and dependent variables as part of the development of identifying a new research problem are provided by Carter & Lubinsky [16] and shown in Box 3.

The ’Usable’ item examines whether the outcome variables that need to be quantified in the context of the research problem are usable by clinicians, researchers, and patients. Research findings should contribute to the existing body of evidence, enhancing the understanding of specific outcomes and contributing to the overall knowledge in the field [37, 38]. Scientific evidence in health care needs to be translated into practice to ensure rapid implementation and to reduce the gap between research and practice. To facilitate this, reporting guidelines for implementation strategies are provided, such as the ‘Standards for Reporting Implementation Studies (StaRI)’ guidelines or the Action, Actor, Context, Target, and Time (AACTT) framework introduced elsewhere [39]. Successful implementation of one’s own research findings can be achieved by aligning implementation strategies with implementation outcomes, which should be taken into account when specifying the research problem, objectives, and research question. Additionally, investigators should evaluate the clinical relevance of the results to patients. Clinical relevance refers to a significant improvement in measurement or treatment and should not be conflated with statistical significance [40].

The item ’Accurate’ asks whether the identified research problem is precisely described to clearly define the study objectives. Research problems are often multifaceted [41]. Therefore, researchers should articulate their ideas and existing evidence accurately and clearly [42], especially when trying to communicate complex ideas [27]. These ideas and current evidence should be incorporated into well-defined study objectives and clinical questions, as the reliability and validity of study results depend on the overall study design. This also includes reproducible methodology, careful data collection and analysis, and clear reporting of results [43, 44]. Within this item, the researcher should consider the PICO(T) format in advance so that the research problem can be more easily aligned with the clinical question and the hypothesis, which is considered to be the researcher’s reasoned estimate of the outcome of the research.

The item ’Restricted’ investigates whether the identified research problem and the variables can be reasonably confined, enabling control and differentiation from other research problems. Restricting, narrowing or limiting the clinical research problem can be achieved by using some strategies, including ‘aspect’, ‘components’, ‘methodology’, ‘place’, ‘relationship’, ‘time’, ‘combination’ [31]. ‘Aspect’ involves focusing on a specific facet of the research problem. ‘Components’ entails breaking down the primary variable into smaller parts to facilitate more accurate analysis. This allows the researcher to gain a more thorough understanding of the problem before proceeding to other steps in the research process [41]. ‘Methodology’ is the process of gathering information so that the amount of interpretive analysis required to address the research problem can be minimized [31]. This is where Kuhn’s [45] three methods of ‘isolate and structure’, ‘magnify the problem’, and ‘search for theory’ can be applied. The methods are described in Box 4.

‘Place’ means reducing the geographical unit of analysis in order to narrow the focus. ‘Relationship’ refers to how certain variables are related to each other. ‘Time’ refers to the appropriate timing of the study period and the timely start of the study and reporting of results after completion of data collection. ‘Type’ means focusing the research problem on a particular class of people, places, or phenomena. ‘Combination’ recommends using two or more of the aforementioned strategies to narrow the research problem [31], and to help focus it precisely on the research question.

The item ‘Eligible’ assesses whether the research problem and variables are eligible in terms of your research interests, research vision, beliefs, desires, and needs (personal factor) or the existing evidence in the field and priorities for future research, e.g. according to the James Lind Alliance ( agreed by patients, funders, supporters, collaborators, caregivers, or policy makers (stakeholder factor); feasibility of the research; ethical standards, including Good Clinical Practice, which is the international standard for the design and conduct of clinical trials to ensure ethical and scientific integrity [46], and the EU General Data Protection Regulation [47]. Good research begins with intrinsic motivation for a specific area of research, protecting against discouragement and disinterest in the research as it progresses [41]. Then the researcher should begin to ask questions about the topic that will lead to the information needed to answer them. Suggested questions are ‘who’, ‘what’, ‘when’, ‘where’, ‘how’, and ‘why’ to engage the researcher’s critical thinking [31]. Examples of these questions may include the following:

I want to find out….

• who has an increased risk of suffering a particular injury?

• what the typical comorbidities are for a particular disease?

• when a particular disorder usually occurs?

• where a particular injury occurs most often?

• how a particular complaint should be treated?

• why it is necessary for the therapist to know and care about a particular clinical problem?

Certain questions present challenges, while others do not. A research problem, which is also considered a conceptual problem, refers to an issue that a researcher aims to resolve by examining pertinent data. Research priorities hold significance in every discipline as they contribute to the advancement of specialized knowledge within specific research areas relevant to a particular field of study [2]. Researchers should demonstrate a willingness to question established beliefs and invest the time necessary to understand the issues surrounding the research problem, rather than jumping directly to finding solutions to specific problems [41].

The item ‘Investigable’ assesses whether the research problem can lead to facts, not opinions [48], and is clearly linked to the overall goal of the research topic. Furthermore, it asks whether the study can be conducted based on the identified research problem in terms of clinical trial type and phase, budget, informed consent, sites, resource constraints in terms of personnel and facilities, and timeline [7], as well as the regulatory environment, inadequate patient recruitment, enrollment, and retention [49].

The ‘Timely’ item assesses whether the identified research problem is current in the scientific literature and has not already been extensively researched by other authors, when it should be investigated (start of study), how long the research process will realistically take (timeframe of study), including all preparations for data collection, data collection itself, data processing and analysis, and when the results of the research project should be published. This is closely related to the item ‘Investigable’. Depending on the study design, e.g., clinical trial, observational study or systematic review, established checklists, such as the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement [50], the Strengthening the reporting of observational studies in epidemiology (STROBE) statement [51], or the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA 2020) statement [52] can be used to guide the steps to be taken to manage the research.