Reporting Guidelines

Standards for Complete, Transparent, and Reproducible Research Reporting

Authors must follow the reporting guideline appropriate to the research design, analytical approach, and disciplinary context. Reporting guidelines support complete, transparent, reproducible, and critically assessable scholarly reporting in public health, pharmacy, pharmaceutical sciences, clinical pharmacy, health services, pharmacotherapy, medication safety, and related fields.

Compliance with a reporting guideline does not replace sound study design, ethical conduct, appropriate analysis, or critical scientific interpretation. Authors remain responsible for the accuracy, completeness, consistency, and verifiability of all information reported in the manuscript.

Selecting the Appropriate Guideline

Authors should select the guideline based on the actual study design rather than the manuscript title, topic, or statistical method alone. A manuscript may require more than one reporting guideline when it combines multiple designs or reporting components.

Examples include:

• A randomized trial with a detailed intervention may require both CONSORT and TIDieR.
• A systematic review of diagnostic studies may require PRISMA and the relevant diagnostic-review extension.
• A mixed-methods implementation study may require GRAMMS together with an appropriate quantitative or qualitative guideline.
• An observational pharmacoepidemiology study should apply STROBE and any relevant discipline-specific extension.
• A pharmacoeconomic evaluation conducted alongside a clinical trial may require CHEERS and CONSORT.

General Reporting Requirements

All manuscripts should report the following information when applicable:

• Research problem, scientific context, evidence gap, rationale, objectives, and hypotheses
• Study design and analytical framework
• Setting, geographic scope, institutional context, and study dates
• Population, eligibility criteria, sampling, recruitment, and participant flow
• Sample-size calculation, statistical power, or other sample-size justification
• Variables, outcomes, exposures, interventions, covariates, confounders, and operational definitions
• Data sources and data-collection methods
• Validity, reliability, calibration, or quality of measurement instruments
• Intervention components, dosage, duration, provider, delivery method, and adherence when relevant
• Data-management and quality-assurance procedures
• Statistical, qualitative, laboratory, or mixed-methods analysis procedures
• Software name, version, packages, and major analytical settings
• Effect estimates, confidence intervals, measures of uncertainty, and clinically relevant thresholds
• Handling of missing data, exclusions, outliers, protocol deviations, and sensitivity analyses
• Adjustment variables, model assumptions, diagnostics, and validation procedures
• Ethics approval, informed consent, confidentiality, and study registration
• Funding sources, funder role, conflicts of interest, and author contributions
• Study limitations, potential sources of bias, and limits to generalizability
• Implications for public health, pharmacy, clinical practice, policy, education, research, or healthcare delivery

Statistical Reporting

• Describe statistical methods with sufficient detail to permit evaluation and replication.
• Report the rationale for selecting each major analytical method.
• Present effect sizes and confidence intervals whenever appropriate.
• Do not interpret p-values as the sole indicator of scientific or clinical importance.
• Report exact p-values unless they are extremely small.
• Distinguish prespecified analyses from exploratory or post hoc analyses.
• Describe adjustment for confounding and the basis for covariate selection.
• Report assumptions, diagnostic procedures, goodness-of-fit measures, and model-validation methods.
• Explain procedures for multiple comparisons when applicable.
• Report missing-data mechanisms and the methods used to address missing observations.
• Provide sufficient information to understand participant exclusions and analytical sample construction.
• Avoid claiming causality from study designs that support only association.

Qualitative Research Reporting

• State the qualitative approach, theoretical orientation, or methodological tradition.
• Describe researcher characteristics, reflexivity, and relationships with participants when relevant.
• Explain participant selection, recruitment, setting, and sample adequacy.
• Describe interview guides, observation procedures, recording, transcription, and field notes.
• Explain coding, theme development, data interpretation, and the use of qualitative software.
• Report procedures used to support credibility, dependability, confirmability, and transferability.
• Provide representative participant quotations or other supporting evidence.
• Protect participant confidentiality and remove identifying information.

Systematic and Scoping Reviews

Review manuscripts should report:

• The review question, rationale, and objectives
• Protocol development and registration information
• Eligibility and exclusion criteria
• Information sources, databases, registries, websites, and search dates
• Complete and reproducible search strategies for all principal databases
• Study-selection procedures and the number of reviewers involved
• Data-extraction procedures and mechanisms for resolving disagreements
• Risk-of-bias or critical-appraisal methods where applicable
• Data items, outcomes, effect measures, and assumptions
• Qualitative or quantitative synthesis methods
• Methods for assessing heterogeneity, sensitivity, subgroup effects, and publication bias
• Study-selection flow diagram
• Characteristics of included studies
• Risk-of-bias findings
• Evidence limitations, applicability, and certainty assessment where relevant

Pharmacy and Pharmaceutical Research Reporting

Manuscripts involving medicines, pharmacy services, pharmaceutical products, or laboratory procedures should additionally report:

• Generic medicine names, dosage forms, strengths, routes, and dosing schedules
• Intervention-provider qualifications and pharmacy-practice settings
• Medication-use definitions, adherence measures, prescribing indicators, and classification systems
• Pharmacovigilance definitions, causality-assessment methods, and adverse-event classification
• Drug-utilization metrics, denominators, and observation periods
• Laboratory materials, reagents, instruments, manufacturers, and model numbers when relevant
• Formulation composition, preparation procedures, storage conditions, stability methods, and quality-control testing
• Analytical-method validation, calibration, precision, accuracy, specificity, sensitivity, and detection limits
• Clinical and pharmaceutical significance in addition to statistical significance
• Applicable regulatory, pharmacopoeial, or professional standards

Checklist Submission

When requested, upload the completed reporting checklist as a supplementary file. Indicate the manuscript page number, table, figure, appendix, or section in which each reporting item is addressed. Mark an item as not applicable only when it genuinely does not apply to the study.

• Do not leave applicable checklist items blank.
• Do not indicate compliance when the required information is absent from the manuscript.
• Provide a brief explanation when an item is not applicable.
• Ensure that checklist page references correspond to the final submitted manuscript.
• Upload the relevant flow diagram as a separate file or include it in the manuscript when required.