More often than not, biomedical research begins with a simple, but broad idea: “I want to study diabetes,” “I am interested in postoperative pain,” or “I want to know why some patients respond poorly to treatment.”
These ideas serve as the crucial starting points in the journey into the long and winding roads of medical research, and determine the goal towards which the budding researcher aims their scientific intellect. However, to properly realise these goals, an idea needs something extra. That is the clarity and direction that underlies any scientific enquiry, and a specific inquiry, that the researcher aims to solve. Once these qualities are incorporated into the broad idea, it results in what is known as a research question.
A research question gives direction to the study, helps determine the design, identifies what data must be collected, and keeps the project focused from protocol development to analysis, reporting, publication, and dissemination.[1, 2]
Interestingly, however, while every research project begins with a question, but not every question is ready to become a study. “Does obesity affect pregnancy outcomes?” or “Is spinal anaesthesia better than general anaesthesia?” may express an area of interest, but they leave too many decisions unanswered. Who exactly will be studied? What exposure or intervention is being considered? What will it be compared with? Which outcome matters? A well-framed research question narrows these uncertainties and becomes the foundation on which the study design, objectives, variables, and analysis are built.[3, 4]
In this article, we will try to understand the exact steps that any aspiring biomedical researcher should take in order to formulate an effective research question for their study.
Start With the Knowledge Gap
A useful research question should arise from something that is genuinely uncertain. Before drafting it, it is crucial to identify what is already known and where the gap lies. Existing studies may have produced conflicting findings, overlooked a particular population, used an unsuitable outcome, or simply never examined the problem in the researchers’ clinical setting.[3]
For example, if the broad idea for an upcoming research project is, “I want to study postoperative pain.”, then the gap in the existing literature regarding the topic can be identified by doing a review of the published studies on the topic. This literature review might reveal uncertainty regarding whether a particular regional block reduces opioid requirements following lumbar spine surgery, which in turn might provide something much more concrete to investigate.
Give the Question a Framework
The next step in formulating a good research question is to choose a question framework. This framework acts sort of a scaffold, around which the research question is constructed. There are multiple frameworks available, each of which is specific to a different type of study design. For quantitative studies, the most commonly used framework is PICO: [3, 4]
- P – Population or Problem
- I – Intervention or Exposure
- C – Comparison
- O – Outcome
Let us suppose we begin with the idea:
“Effectiveness of erector spinae plane block in postoperative analgesia”
When the PICO framework is applied to it, this idea can be refined as per the following criteria:
Adults undergoing elective lumbar spine surgery
Erector spinae plane block
Conventional intravenous analgesia
Postoperative analgesia as measured by postoperative opioid consumption
Once these criteria are clarified, the resulting question becomes much clearer:
“In adults undergoing elective lumbar spine surgery, does an erector spinae plane block reduce postoperative opioid consumption compared with intravenous analgesia?”
This leads to a much clearer and methodologically feasible research question, based on which the study can be designed and objectives fixed.
It has to be kept in mind, however, that the choice of the research framework should be made in such a way that it properly fits the proposed research and design. For example, the PICo (Population/Problem, Phenomenon of Interest, and Context) framework is traditionally used for qualitative research.[3,5] A short reference guide of different research frameworks are given as follows.
| Question Type | Example Research Question | Suggested Framework(s) |
|---|---|---|
| Effectiveness / Intervention | In patients with knee osteoarthritis, does supervised physiotherapy reduce pain compared with conventional treatment? | PICO, PICo/PICoS, PIO, PIPOH, CIMO, EPICOT, PCC |
| Association / Correlation | Is prolonged smartphone use associated with poor sleep quality among medical students? | PCC, PICo/PICoS, EPICOT, PICO |
| Prevalence / Incidence | What is the prevalence of iron-deficiency anemia among pregnant women attending antenatal clinics in rural India? | CoCoPop, PEO, PCC |
| Risk / Prognostic Factor | Which clinical factors predict the development of acute kidney injury among patients admitted to intensive care units? | PECO/PECOS, PEO, EPICOT |
| Qualitative / Experience-focused | How do parents of children diagnosed with autism spectrum disorder experience challenges in accessing healthcare services? | SPIDER, SPICE, PICo/PICoS, ECLIPSe, PCC |
| Diagnostic Test Accuracy | How accurate is ultrasonography in diagnosing acute appendicitis compared with histopathological examination? | PIRD, EPICOT-T |
| Economic Evaluation | Is telemedicine-based follow-up more cost-effective than conventional outpatient visits for patients with type 2 diabetes mellitus? | PICO, EPICOT, CIMO, PIO |
| Scoping / Mapping | What evidence is available regarding the applications of artificial intelligence in the early detection of diabetic retinopathy? | PCC, PICo/PICoS, ECLIPSe, SPICE |
Giving the research question the SMART Test
Once the research question is built around the framework, it is advisable to apply the iSMART criteria to it, so as to refine it further. The SMART criteria is traditionally applied more directly to research objectives than to the research question itself.[4, 6] Nevertheless, its components provide a useful final check when designing a question for biomedical research, as it makes developing objectives and designing the study that much easier. The Smart criteria are as follows:
- Specific: Does the question clearly identify what the researcher intends to investigate? “Does hypertension affect pregnancy?” is vague; specifying hypertensive disorder, population, and outcome immediately improves it.
- Measurable: Can the important variables actually be measured? “Improved recovery” is difficult to interpret unless recovery is defined using measurable outcomes such as pain score, length of stay, postoperative complications, or time to ambulation.
- Achievable: Can the study realistically be completed with the patients, time, equipment, expertise, and resources available? An elegant question requiring five years of follow-up may be unsuitable for a postgraduate dissertation with an 18-month timeline.[6]
- Relevant: Will answering the question contribute something clinically or scientifically useful? Relevance comes from the identified knowledge gap rather than merely from choosing a fashionable topic.[4]
- Time-bound: Where appropriate, the researcher should specify when the outcome is measured. “Postoperative pain” becomes considerably clearer when defined as pain during the first 24 postoperative hours.
Applying the SMART to our previously designed research question of “In adults undergoing elective lumbar spine surgery, does an erector spinae plane block reduce postoperative opioid consumption compared with intravenous analgesia?”, we can further refine it as follows:
| SMART Criterion | Application to the Research Question |
|---|---|
| S – Specific | Defines adults undergoing elective lumbar spine surgery, with erector spinae plane block (ESPB) as the intervention and intravenous analgesia as the comparator. |
| M – Measurable | Postoperative opioid consumption can be quantified in milligrams of morphine-equivalent dose. |
| A – Achievable | Can be investigated through a prospective comparative study using standardized analgesic protocols and postoperative monitoring. |
| R – Relevant | Addresses postoperative pain management and the potential opioid-sparing benefits of regional anaesthesia. |
| T – Time-bound | Specifies opioid consumption during the first 24 hours following surgery. |
The refined research question therefore becomes:
Among adults aged 18 years and above undergoing elective lumbar spine surgery, does ultrasound-guided erector spinae plane block, administered alongside standard intravenous analgesia, reduce cumulative postoperative opioid consumption, measured in morphine-equivalent doses, during the first 24 hours after surgery compared with standard intravenous analgesia alone?
Now that we have reviewed the method of designing and refining a research question, before finalising one for our next research, we need to keep in mind that a good research question does not need to sound complicated. It only needs to tell you clearly what you want to find out and how you could realistically find it out.
If any answer is “not quite,” we need to refine the question before moving further. A few extra minutes spent sharpening the research question can prevent months of avoidable difficulty later.
References
- Bahadoran Z, Mirmiran P, Kashfi K, Ghasemi A. Biomedical research: formulating a well-built and worth-answering research question. Addict Health. 2025;17(1):1564. doi:10.34172/ahj.1564.
- Barroga E, Matanguihan GJ. A practical guide to writing quantitative and qualitative research questions and hypotheses in scholarly articles. J Korean Med Sci. 2022;37(16):e121. doi:10.3346/jkms.2022.37.e121.
- Cornell University Library. Draft your research question: A guide to evidence synthesis [Internet]. Ithaca (NY): Cornell University Library; [cited 2026 Oct 13]. Available from: Cornell University Library guide
- Dhir SK, Gupta P. Formulation of research question and composing study outcomes and objectives. Indian Pediatr. 2021;58(6):584-588. doi:10.1007/s13312-021-2246-y.
- Booth A, Noyes J, Flemming K, Moore G, Tunçalp Ö, Shakibazadeh E. Formulating questions to explore complex interventions within qualitative evidence synthesis. BMJ Glob Health. 2019;4(Suppl 1):e001107. doi:10.1136/bmjgh-2018-001107.
- Ciolino JD, Spino C, Ambrosius WT, Khalatbari S, Messinger Cayetano S, Lapidus JA, et al. Guidance for biostatisticians on their essential contributions to clinical and translational research protocol review. J Clin Transl Sci. 2021;5(1):e161. doi:10.1017/cts.2021.814.