quality-assessment-protocol

Research

Methodological quality and bias risk assessment of included studies using validated tools

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Quality Assessment Protocol Tactic

Systematically assess methodological quality and risk of bias for each included study using domain-appropriate validated tools.

Stages

Stage 1: Tool Selection

Select the appropriate quality assessment tool based on study design.

Study Design	Tool	Domains
RCT	RoB 2.0	Randomization, deviations, missing data, measurement, selection
Non-randomized interventions	ROBINS-I	Confounding, selection, classification, deviations, missing, measurement, reporting
Diagnostic accuracy	QUADAS-2	Patient selection, index test, reference standard, flow/timing
Prediction models	PROBAST	Participants, predictors, outcome, analysis
Observational	Newcastle-Ottawa	Selection, comparability, outcome/exposure

Decision: Match tool to study design. Use one tool consistently within a meta-analysis.

Stage 2: Per-Study Assessment

Apply the selected tool to each included study.

Assess each domain independently
Use signaling questions to guide domain judgments
Assign domain-level judgment (Low/Some Concerns/High risk)
Document supporting rationale for each judgment
Resolve disagreements with explicit criteria

SOPs: risk-of-bias-assessment

Stage 3: Summary and Visualization Planning

Plan the summary presentation of quality assessments.

Traffic light plot (per-study, per-domain)
Summary bar chart (proportion at each risk level per domain)
Overall risk-of-bias judgment per study
Sensitivity analysis groupings (low-risk only vs all)
GRADE certainty assessment contribution

SOPs: sensitivity-analysis-design

Minimum Yield

Per execution of this tactic:

At least 5 studies assessed
All domains of the selected tool evaluated per study
Supporting rationale documented for each judgment
Summary visualization plan produced
Sensitivity groupings defined

Output Format

quality_assessment:
  tool_used: [RoB2/ROBINS-I/QUADAS-2/PROBAST/NOS]
  assessments:
    - study_id: [identifier]
      domains:
        - domain: [name]
          judgment: [Low/Some Concerns/High]
          rationale: [supporting text]
      overall: [Low/Some Concerns/High]
  summary:
    low_risk_count: [N]
    some_concerns_count: [N]
    high_risk_count: [N]
    problematic_domains: [most common high-risk domains]
  sensitivity_groups:
    low_risk_only: [study list]
    excluding_high_risk: [study list]

Available SOPs

Optional, no fixed order; the final leaf is always a sop.

SOP	When to use
risk-of-bias-assessment	Assess methodological bias using RoB2, PROBAST, or QUADAS-2 validated tools
sensitivity-analysis-design	Design leave-one-out, influence diagnostics, subgroup analyses, and robustness checks