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

yaml
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]

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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 |

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