03 · What You Need to Know
Build the Method Around the Evidence the Question Requires
Start with the research question, not your preferred technique
Methodological alignment begins before sampling. First identify what kind of evidence would allow you to answer the research question. Only then should you determine who or what can provide that evidence, how it will be measured or generated, how it will be collected, and how it will be analyzed.
This prevents a common reversal in research planning: beginning with an accessible dataset, familiar questionnaire, convenient sample, or preferred statistical technique and then constructing a question that appears to fit it.
The broader alignment between the protocol and the research questions, objectives, and hypotheses should already establish what the study is trying to answer. The next task is to make sure the operational components can actually produce that answer.
Sampling determines whose or what evidence enters the study
Your sampling plan establishes the units from which evidence will be obtained. Those units might be people, classrooms, schools, hospitals, documents, records, organizations, specimens, events, or other entities.
Ask whether the sampling frame and eligibility criteria correspond to the population or cases named in the research question. A study claiming to investigate university faculty, for example, should not quietly rely on a sample consisting almost entirely of one academic rank unless the narrower population is intentional and reflected in the question and interpretation.
Sampling also needs to support the comparisons or analyses you intend to make. If a primary objective compares two groups, both groups must be represented adequately. If the analysis concerns variation among institutions, sampling participants from only one institution cannot produce between-institution evidence.
The unit of sampling and the unit of analysis need to make sense together
Researchers sometimes recruit or select units at one level but analyze the data as though they arose independently at another.
Suppose schools are sampled, classrooms are selected within schools, and students are measured within classrooms. Student observations may be clustered because students in the same classroom or school share environments and experiences. An analysis that treats every student as completely independent may therefore be inappropriate.
The exact analytical solution depends on the design and research question, but the protocol should recognize the structure created by sampling. The analysis cannot pretend that the sampling design did not happen.
Measurement must operationalize the construct in the question
Once you know who or what will provide evidence, ask whether the planned measurements actually represent what you claim to study.
A questionnaire about frequency of generative AI use does not necessarily measure AI literacy. A publication count does not by itself measure research quality. Course grades may capture some dimensions of academic performance but may not be interchangeable with writing proficiency.
Measurement alignment therefore requires more than selecting an instrument with evidence of reliability or validity. The construct represented by the measure must correspond to the construct in the research question, within the population, context, and intended interpretation of the study.
The measurement scale and structure constrain the analysis
The form of the data matters. Categories, counts, continuous scores, repeated measurements, ranked responses, time-to-event data, nested observations, free-text responses, images, and other forms of evidence support different analytical possibilities.
If the planned analysis requires a continuous outcome but the collection instrument records only broad categories, the required information may no longer exist. If the research question concerns change but only one measurement occasion is collected, no statistical sophistication can reconstruct the missing temporal comparison.
WHO's recommended protocol format explicitly connects methodology with measurements and observations, while its data-management and statistical-analysis section asks researchers to outline the statistical methods, sample-size rationale, and handling of missing or spurious data. This reflects an important planning principle: the analysis must be designed for the data the study will actually generate.
Data collection must preserve the meaning of the measurement
An appropriate measure can still produce weak evidence if it is administered inconsistently.
Consider a performance test intended to compare two groups. If one group completes it before an instructional activity and the other afterward, the measurement conditions are no longer comparable. If some participants receive additional explanations from data collectors while others do not, the procedure itself may introduce variation.
Protocols should therefore describe consequential procedures, timing, conditions, instructions, personnel responsibilities, and other factors needed for consistent data generation. WHO guidance emphasizes detailed description of procedures, measurements, observations, instruments, and, for multisite research, standardization of methodology across sites.
Timing is part of methodological alignment
When data are collected can be as important as what is collected.
If an objective concerns immediate learning after an intervention, a measure six months later may answer a different question. If the objective concerns persistence, measuring only immediately afterward is insufficient. Longitudinal questions require a schedule capable of representing change over the relevant period.
Timing also matters when exposures, outcomes, or participant characteristics can change. The protocol should make clear which observations belong together analytically and why their timing supports the intended inference.
The analysis plan should be written backward into the data collection plan
One of the most effective alignment checks is to begin with the planned analysis and work backward.
For every primary analysis, list the information it requires. Which outcome? Which predictor, exposure, group, or condition? Which covariates? Which time points? Which participant identifier? Which grouping variables? Which sampling weights or cluster identifiers, if applicable? How will missing observations be recognized?
Then locate where each item is generated in the data collection plan. If a required variable has no source, the analysis cannot be performed as planned.
| Planned analytical need |
What must exist in the data |
What the protocol must ensure |
| Compare two groups |
Reliable group identifier and comparable outcome |
Both groups are sampled and measured under appropriate conditions |
| Estimate change over time |
Comparable measurements at relevant time points |
Participants or units can be linked across measurement occasions |
| Adjust for specified covariates |
Usable measurements of each covariate |
Covariates are collected for the appropriate participants and time frame |
| Account for clustering |
Identifiers for relevant clusters |
Sampling and data systems preserve school, site, class, household, or other cluster membership |
| Analyze interview material |
Data of sufficient depth and form for the chosen qualitative approach |
Data-generation procedures and recording practices support the intended analysis |
Sample size should correspond to the analysis you actually intend to conduct
A sample-size calculation or justification should not exist independently from the primary objective and analytical plan.
If a study's primary analysis is a comparison between groups, the sample-size assumptions should relate to that comparison. If the primary model requires several parameters or a clustered design, the design implications should be considered rather than relying on a calculation for an unrelated simpler analysis.
WHO protocol guidance expects researchers to explain the reason for the selected sample size and, for statistical studies where relevant, the study's power and proposed analytical methods.
The principle is broader than formal power calculations. Whatever rationale determines the amount of evidence collected should correspond to what the analysis is expected to accomplish.
Missing data planning begins during study design
Missing data are often treated as a statistical problem that can be addressed after collection. Yet their causes frequently originate in sampling, measurement, and data collection.
A questionnaire may allow respondents to skip essential items. Follow-up procedures may make attrition more likely for particular participants. A data-entry system may fail to require identifiers needed to link repeated observations. These are design and collection problems before they become analytical ones.
WHO specifically recommends that protocols address procedures for missing or spurious data within the analysis plan. Planning should therefore consider both how missingness might be reduced during collection and how remaining missing observations will be handled analytically.
Qualitative studies need alignment too
Methodological coherence is not limited to quantitative research. A qualitative study asking about how participants make sense of a complex experience needs sampling capable of reaching relevant perspectives, data-generation methods capable of eliciting sufficiently rich material, and an analytical approach compatible with the question and methodology.
A short checklist questionnaire may be easier to administer than an interview, but convenience does not make it suitable for a question about meaning or lived experience. Conversely, lengthy interviews are unnecessary if the question merely requires a narrowly defined factual measure.
WHO protocol guidance explicitly asks projects using qualitative approaches to specify how their data will be analyzed in sufficient detail. The same forward-and-backward alignment check can therefore be used across methodological traditions.
Changing one component may require changes elsewhere
Suppose an instrument becomes unavailable and the research team substitutes another measure. That may alter the construct being represented, score distribution, measurement scale, comparability with earlier observations, sample-size assumptions, or planned analysis.
A protocol amendment should therefore not be evaluated only at the point where the change occurs. Ask what else depends on that component.
Local change
A modification affects one procedure without materially changing the evidence required elsewhere in the study.
Systemic change
A modification alters assumptions or requirements in sampling, measurement, data collection, analysis, or interpretation and therefore requires broader protocol review.
Watch Out
Do not assume that a familiar statistical technique can rescue data that were generated for a different question. Analysis is the final stage of an evidence chain. It cannot restore a population that was never sampled, a construct that was never measured, a comparison group that never existed, or a time point that was never observed.