Writing the Background and Problem Statement

Overview

The background and problem statement explain why a study should exist. They guide the reader from an important health context to a precise unresolved problem and show how the proposed study responds to that problem. They are not general essays on the disease, service or intervention.

The background synthesises the evidence needed to understand the issue. It establishes the burden or context, summarises relevant current knowledge, identifies limitations in that knowledge and progressively narrows towards the intended study. The problem statement is the focused culmination of that argument. It states what remains unknown or inadequate, whom it affects, why the gap matters and what knowledge the study will generate.

The two sections may appear under separate headings or be integrated within an introduction, depending on institutional format. Their functions remain distinct. Health-research guides emphasise a logical progression from the problem and existing knowledge to the question and objectives [1–3].

Why this matters

Reviewers often encounter backgrounds that are long but unpersuasive. They describe disease definitions, global prevalence, pathophysiology and many previous studies but never establish the exact uncertainty addressed by the proposal. The resulting objectives appear abruptly and the reader must infer why the study is needed.

A strong background performs selective reasoning. Every paragraph contributes to one argument: this problem is important, this is what is currently known, this is the specific gap, and this study is an appropriate next step. The final question and objectives should be recognisable consequences of that argument [4,5]. This clarity assists scientific review, ethics review, protocol implementation and later manuscript writing.

Background and problem statement serve different purposes

The background establishes the argument

A background normally answers these questions:

• What health condition, population, service or policy context is relevant?
• What is the scale or consequence of the issue?
• What has previous research established?
• Where is the evidence inconsistent, incomplete, methodologically weak or inapplicable?
• What contextual feature makes the proposed setting important?
• What focused gap leads directly to the study question?

The problem statement concentrates the argument

A problem statement normally answers:

• What exactly is not known or not working adequately?
• Who or what system is affected?
• Why does this uncertainty have a meaningful consequence?
• Why can existing evidence or routine information not resolve it?
• What will the proposed study determine, explore or evaluate?

A funnel structure for the background

A practical background can move through six stages.

1. Define the focused context

Introduce only the concepts needed to understand the problem. For a postpartum testing study, a short explanation of gestational diabetes and future dysglycaemia may be necessary. A detailed review of antenatal pharmacology is not.

2. Establish importance

Use credible evidence to describe burden, severity, inequity, service consequence, cost or patient importance. Avoid unsupported terms such as “alarming”, “rising rapidly” or “a major problem” unless the evidence demonstrates them.

3. Synthesise what is known

Organise evidence by themes or claims rather than describing one study per sentence. Compare populations, settings, methods and findings. Explain what the collective evidence supports and where uncertainty remains.

4. Identify limitations in current evidence

The gap may concern absent data, inconsistent findings, weak measurement, exclusion of a relevant group, short follow-up, insufficient contextual detail, lack of implementation evidence or inability to distinguish competing explanations.

5. Explain why the setting or population matters

Local context should be justified, not merely named. Referral pathways, disease distribution, language, resources, policy, clinical practice or data systems may make existing estimates inapplicable. State the mechanism by which context could affect the answer.

6. Lead directly to the study

The final paragraph should make the proposed question and objectives feel inevitable rather than surprising. It should not claim that the study will “solve” a broad problem when it can only contribute one piece of evidence.

PROTOCOL CHECKLIST

Plan each background paragraph

For every paragraph, record:

• the claim the paragraph must establish;
• the strongest source supporting that claim;
• how the paragraph advances the argument;
• what limitation or transition leads to the next paragraph; and
• whether the material is essential to the research question.

Remove material that is interesting but does not support the problem, question, methods or interpretation.

Using evidence responsibly

Prefer synthesis to citation accumulation

A sentence followed by many references is not necessarily a synthesis. Explain whether studies agree, how their designs differ and which limitations are relevant. A systematic review may provide an efficient overview, but important recent or setting-specific primary studies may still be needed.

Match the source to the claim

Use surveillance reports for burden, original validation studies for instrument performance, systematic reviews for an evidence overview and official guidance for current recommendations. A single small study should not support a sweeping population claim.

Distinguish absence of evidence from evidence of absence

A literature search that finds few studies does not prove that a phenomenon does not exist. State that evidence is limited, sparse or not identified under the documented search rather than claiming that “there is no evidence” without a comprehensive review.

Avoid using outdated background merely because it is familiar

Stable foundational sources may remain appropriate, but estimates, policies, technologies and guidelines can change. Search dates and the relevance of older evidence should be explicit where necessary.

Writing the problem statement

A concise problem statement can follow this sequence:

1. Situation: Identify the population and important condition or service issue.
2. Current evidence: State the most relevant established knowledge.
3. Gap: Specify what cannot yet be concluded or measured adequately.
4. Consequence: Explain why the gap impedes a decision or creates risk, inequity or inefficiency.
5. Study response: State the knowledge the proposed research will produce.

The problem statement should not contain every literature detail. It should be understandable when read alone, but every substantive claim should be supported by the preceding background or an appropriate citation.

Weak and improved problem statements

illustrative

Weak version

Gestational diabetes is a common condition and women should attend postpartum testing. However, many do not attend. Therefore, this study is important to increase awareness.

Improved version

Women with gestational diabetes require postpartum assessment to identify persistent dysglycaemia, but completion across the hospital–primary-care pathway cannot currently be estimated because tests performed outside the hospital are not consistently linked. The stages of follow-up loss and modifiable patient and service factors are also unknown. This prevents the service from selecting and monitoring a targeted improvement strategy. The proposed study will therefore estimate testing completion within 12 weeks and examine factors associated with completion.

The improved version separates the observed information problem from a presumed explanation. It also identifies the decision that the research will support.

Common structures that weaken the background

The textbook chapter

The writer provides definitions, classification, mechanisms and treatment details that do not contribute to the research problem. The remedy is to select only information required for the study argument.

The global-to-local prevalence list

The background lists estimates from the world, region, country and hospital without explaining differences in methods or how the estimates relate to the question. The remedy is to synthesise and interpret rather than tour locations.

The one-study-per-paragraph catalogue

This structure tells the reader what each author found but not what the literature collectively means. Group studies by the claim, methodological issue or source of disagreement.

The unsupported local assertion

Statements such as “patients in our hospital have poor knowledge” require data. If the claim is a preliminary observation, label it and explain how it was obtained.

The gap-by-geography argument

“No study has been conducted in this institution” is not enough. Explain why institutional context might change the phenomenon, measurement or intervention.

Worked example

WORKED EXAMPLE

A paragraph-level background plan

Paragraph 1 — clinical importance: Explain why postpartum identification of persistent dysglycaemia matters after gestational diabetes.

Paragraph 2 — expected care pathway: Summarise recommended timing and the intended transition from obstetric to primary care.

Paragraph 3 — current evidence: Synthesise evidence showing variable completion and the types of patient and service barriers reported elsewhere.

Paragraph 4 — local information limitation: Explain that hospital records miss tests performed in other facilities and therefore cannot provide a valid completion estimate.

Paragraph 5 — actionable gap: State that the magnitude, points of loss and modifiable correlates within the local pathway are unknown.

Final problem statement: Connect the gap to the need to design and evaluate a targeted follow-up strategy.

This plan produces a shorter but more persuasive background than a broad review of all aspects of gestational diabetes.

Appraising the background and problem statement

APPRAISAL CHECKLIST

Check the logic of the introduction

• Does the opening establish the specific health context rather than an excessively broad topic?
• Are burden and importance supported by appropriate, current sources?
• Is previous evidence synthesised by claim, theme or methodological issue?
• Are disagreement and uncertainty represented fairly?
• Is the precise evidence gap explicit?
• Is local relevance justified by more than location alone?
• Does the problem statement identify a consequence of the gap?
• Does the proposed study response match the gap without overpromising?
• Do the final question and objectives follow directly from the argument?

Suggested protocol wording

Common mistakes

Knowledge check

What is the main difference between the background and the problem statement?

Answer and reasoning

The background develops the evidence-based argument from context and current knowledge to the gap. The problem statement concentrates that argument into the specific unresolved problem, its consequence and the knowledge the study will generate.

Why is a one-study-per-paragraph structure often weak?

Answer and reasoning

It can become a catalogue that leaves synthesis to the reader. A stronger structure groups evidence around claims, patterns, disagreements or methodological limitations and explains what the literature collectively supports.

When is local context a defensible reason for a new study?

Answer and reasoning

When a contextual feature could plausibly change the estimate, experience, implementation or decision—for example, a different referral pathway, language, resource constraint or population distribution—and existing evidence cannot address that difference.

A background contains accurate pathophysiology but it does not influence the question or methods. What should the author do?

Answer and reasoning

Condense or remove it. Accuracy alone does not make material relevant. Background content should help establish importance, current knowledge, the gap or the rationale for the study response.

Key take-home messages

SUMMARY

Key take-home messages

• The background is a selective evidence-based argument, not a textbook chapter.
• Move from focused context and importance to current knowledge, the specific gap and the study response.
• The problem statement identifies the unresolved problem, affected population, consequence and required knowledge.
• Synthesis explains what a body of evidence means; citation accumulation does not.
• Local research requires a contextual rationale beyond the absence of a previous local publication.
• The question and objectives should follow logically from the final background paragraph.

References

1. World Health Organization Regional Office for the Eastern Mediterranean. A practical guide for health researchers. Cairo: World Health Organization; 2004. https://iris.who.int/handle/10665/119703
2. World Health Organization Regional Office for the Western Pacific. Health research methodology: a guide for training in research methods. 2nd ed. Manila: World Health Organization; 2001. https://iris.who.int/handle/10665/206929
3. Browner WS, Newman TB, Cummings SR, Grady DG, Huang AJ, Kanaya AM, et al. Designing clinical research. 5th ed. Philadelphia: Wolters Kluwer; 2022.
4. Haynes RB. Forming research questions. J Clin Epidemiol. 2006;59(9):881–886. https://doi.org/10.1016/j.jclinepi.2006.06.006
5. Farrugia P, Petrisor BA, Farrokhyar F, Bhandari M. Research questions, hypotheses and objectives. Can J Surg. 2010;53(4):278–281.