Lancet rebuttal

Reviewer Rebuttal (lancet-rebuttal)

When to trigger

• A decision letter arrives (reject / major or minor revision).
• You have clinical and statistical reviewer comments and need a strategy before writing.
• A revision is drafted and you need the point-by-point response letter.

Step 0: read the editor's letter first

The editor's framing outranks individual reviewers. Identify:

• The decision type and whether a new review round is implied.
• Which concerns the editor emphasises (load-bearing — address fully).
• Any deal-breaker the editor names (e.g., "the primary analysis must follow the pre-specified SAP," "registration timing must be clarified," "the causal claim must be softened").

A "we would consider a revised manuscript" is an invitation gated on the deal-breaker. Don't treat it as a flat reject, but don't under-deliver.

The statistical reviewer is its own track

The Lancet routinely uses a statistical reviewer. Treat their comments as a distinct, high-priority track:

• Answer with the pre-specified analysis and SAP references; show CIs and absolute effects.
• If asked to add an analysis, add it and label pre-specified vs post-hoc honestly.
• Address ITT/per-protocol, missing-data handling, multiplicity, and subgroup interaction concerns with actual re-analysis, not prose.

Triage every comment into 4 buckets

Bucket	Action
Do (fair, feasible)	Make the change; show it; quote the new text/table/figure.
Do-partial	Do what is feasible; explain the boundary with evidence.
Defend (incorrect/out of scope)	Push back respectfully, with data/citations — not assertion.
Defer (future work)	Acknowledge; add a sentence to the text; don't over-promise.

Most rejections-on-revision come from silently skipping a load-bearing comment or defending where a re-analysis was actually needed.

Response-letter format

For each comment:

Reviewer N (or Statistical Reviewer), Comment k: <verbatim quote of the reviewer>

Response: <what we did / our reasoning>. <Evidence: new table/figure, re-analysis,
effect with 95% CI.>
Changes: "<quoted new manuscript text>" (p. X, lines Y–Z; new table/figure/appendix).

• Open with a short thank-you and a 3–4 line summary of the major changes across the revision.
• Quote each comment verbatim; never paraphrase in a way that softens the reviewer's point.
• Quote the new manuscript text so the editor can verify without hunting.
• Use a consistent visual convention (reviewer text plain; response indented; manuscript quotes in italics/colour).

Tone and causal-language rules (Lancet-specific)

• Respectful and non-defensive; if a reviewer misread the paper, the writing was unclear — fix the writing and explain.
• Keep causal language cautious: if a reviewer says the conclusion outruns the design (e.g., causal claim from observational data, or a superiority claim from a non-inferiority trial), this is the most dangerous comment — either add evidence or narrow the claim in the title, abstract Interpretation, and Discussion, and say you did.
• Concede real limitations explicitly; an honest limitations paragraph builds credibility.

Update the Research in context panel if the evidence base changed

If new studies appeared during review, re-run or update the systematic search and revise "Evidence before this study" and "Implications of all the available evidence" accordingly — and note this in the response (see lancet-research-in-context).

The Lancet-specific reviewer comments and how to land them

The comments that decide a Lancet revision cluster around the venue's identity: registration integrity, the statistical reviewer's re-analysis requests, claim calibration, and the global-health/equity framing. The fix for each is concrete, never rhetorical — the editor verifies it against quoted new text.

Reviewer comment	The venue-specific fix
"Trial not prospectively registered."	Disclose exact registration/enrolment dates; if retrospective, flag it and explain — do not bury it
"Primary outcome switched."	Reconcile to the registered outcome, or document the dated change; label post-hoc analyses
"Causal claim outruns the design."	Narrow the title, abstract Interpretation, and Discussion; say you narrowed it
"Global-health relevance / equity not addressed."	Add the LMIC/PROGRESS-Plus framing in Interpretation; coordinate with lancet-fit
"Statistical reviewer: add ITT/sensitivity analysis."	Run the re-analysis; report effect + 95% CI; show it as a new table, not prose
"Reporting checklist incomplete."	Complete and page/line-map the EQUATOR checklist; resubmit as a supplement

Worked micro-example (illustrative — not a real exchange)

A statistical-reviewer comment on a hypothetical superiority RCT, answered the Lancet way.

Statistical Reviewer, Comment 3: "The primary analysis is reported as per-protocol.
For a superiority trial, the intention-to-treat population should lead."

Response: We agree. We have made the pre-specified ITT analysis primary, with
per-protocol as a labelled sensitivity analysis. The conclusion is unchanged.
Evidence (illustrative): ITT response 60.0% vs 50.2%, absolute risk difference
9.8 pp (95% CI 5.4-14.2; p=0.0003); per-protocol 62.1% vs 50.0% (RD 12.1 pp,
95% CI 7.3-16.9) -> consistent.
Changes: "The primary analysis was by intention to treat..." (p. 8, lines 12-19;
new Table 2 row; appendix table S4 for per-protocol).

The request is answered with an actual re-analysis carrying effects and 95% CIs, the ITT/per-protocol order is corrected, and the new manuscript text is quoted so the editor can verify without hunting — the pattern that converts a statistical-reviewer comment into an accept.

Output format

【Decision type】 reject / major / minor
【Editor's load-bearing concerns】 [...]
【Deal-breaker】 ... → plan to resolve
【Statistical-reviewer track】 [...] → re-analyses planned
【Comment triage】 Do [...] / Do-partial [...] / Defend [...] / Defer [...]
【Claim integrity】 any narrowing of causal/practice claims needed? (re-check lancet-fit)
【Panel update】 systematic search re-run? Evidence-before / Implications revised? yes/no
【Response letter】 drafted point-by-point with quoted changes

Anti-patterns

• Do not silently skip a comment the editor emphasised.
• Do not answer a statistical-reviewer request for re-analysis with prose alone.
• Do not defend an over-reaching causal claim — narrow it.
• Do not draft the response before the manuscript is actually revised.