Cluster-trial extraction adjustment =================================== StatMedAnalysis | Original downloadable worksheet | 6 November 2026 Record the information needed to synthesize a cluster-randomized result. How to use this worksheet Identify the allocation unit and whether the published estimate already accounts for clustering. Prefer an appropriate adjusted estimate with its uncertainty when available. If a design-effect approximation is considered, record cluster sizes, ICC provenance and sensitivity assumptions. Never apply a second adjustment to an already adjusted standard error. Save a working copy and keep the original blank version. Use public, hypothetical or aggregate information only; do not enter patient identifiers, credentials or confidential records. Keep source evidence in your approved project workspace. Mark unresolved text fields UNKNOWN or NOT REPORTED with a reason; never substitute zero for an unknown count. Project/version __________________ Prepared by role/date __________________ Working fields 1. Allocation and observation units Response/evidence: _________________________________________________________ ___________________________________________________________________________ 2. Clusters and participants by arm Response/evidence: _________________________________________________________ ___________________________________________________________________________ 3. Published model and clustering adjustment Response/evidence: _________________________________________________________ ___________________________________________________________________________ 4. Effect estimate and standard error Response/evidence: _________________________________________________________ ___________________________________________________________________________ 5. Cluster size distribution Response/evidence: _________________________________________________________ ___________________________________________________________________________ 6. ICC source and transferability Response/evidence: _________________________________________________________ ___________________________________________________________________________ 7. Approximation or author-query plan Response/evidence: _________________________________________________________ ___________________________________________________________________________ 8. Double-adjustment check Response/evidence: _________________________________________________________ ___________________________________________________________________________ Hypothetical worked case A fictional trial reports a mixed-model treatment contrast with cluster-adjusted SE. Inflating that SE again using a design effect would count clustering twice; the extraction should retain the reported adjusted result and method. Decision rule and limitations Do not synthesize participant-level precision as if observations were independent when clustering was ignored. Escalate missing cluster information and document approximations explicitly. Decision _______________________ Remaining uncertainty ____________________ Next action ____________________ Owner / review date ______________________ Independent check and discrepancy resolution _______________________________ Official method or reporting reference checked 6 November 2026 https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-10 This is an original planning aid, not an official checklist, validated instrument, clinical recommendation or certificate of expert approval. Apply the referenced guidance to the specific design and record any additional requirements.