LivingGLP1
Round 17 · protocol version 0.17.0

Peer review round 17

Round 17: response to reviewers

Protocol version reviewed: 0.17.0. Revised version: 0.18.0.

Verdicts: GPT-6 Astra MINOR REVISION; Fable 5.1 ACCEPT; Grok 4.7 ACCEPT. Grok 4.7 raised no new comments. Every comment is answered below and recorded in ../comments.csv.

Correction to the round 16 response

The response to F16-2 recorded "your text adopted", but the adopted rule simplified the proposal: Kaplan-Meier arms also take their scenario risk from their own likelihood under PR02 alone. It was a partial adoption (F17-0).

Summary of main changes

  • Kaplan-Meier reference inputs: finite standard error from transformed limits at the reported confidence level, or the Greenwood variance.
  • One arm restatement limited to the hazard routes; reference risk named for one usable arm; arm level known status; summed finer intervals for person time.
  • Relative only rule named at its definition; pointer to matters deferred to amendment.

GPT-6 Astra (gpt-6-astra)

C17-1 (minor; Absolute effects). Transformed confidence limits can be infinite, and 1.96 assumes 95 percent coverage.

Response (revised). Agreed; a Kaplan-Meier value needs 0 < F < 1 and a finite positive standard error on g(F) = log{-log(1 - F)}: from a two sided interval (L, U) of known level with 0 < L < U < 1, {g(U) - g(L)}/(2 z_{1 - alpha/2}), otherwise from the Greenwood variance; when no Kaplan-Meier value qualifies, the Poisson and then binomial inputs apply. fable-5.1 (F17-6b) raised the coverage point too.

C17-2 (minor; Absolute effects). The one arm restatement extended log hazard sampling to a reported Aalen-Johansen value used directly.

Response (revised). Agreed; the restatement is limited to the piecewise integration and exponential approximation routes, and the text says it does not apply to a reported Aalen-Johansen cumulative incidence used directly as F_ref.

Fable 5.1 (fable-5.1)

F17-0 (note; Response record). The round 16 response to F16-2 said "your text adopted" although the Kaplan-Meier branch was simplified.

Response (corrected). Agreed; the record should have said partly adopted: every usable arm, including a Kaplan-Meier arm, takes its scenario risk from its own likelihood under PR02 alone, which you judged harmless.

F17-1 (minor; Absolute effects). Poisson input "over one period" excluded summed finer intervals.

Response (revised). Agreed; "over one period, or summed over reported finer intervals".

F17-2 (minor; Absolute effects; priors). Reference risk with one usable arm unnamed; PR02 scope.

Response (revised). Agreed; with one usable arm the reference risk is the posterior median of 1 - exp(-exp(theta_a)), and PR02 applies_to names the single arm and scenario uses.

F17-3 (minor; Absolute effects). Known status for f_a read trial wide.

Response (revised). Agreed; status known for every participant randomized to that arm.

F17-4 (minor; Absolute effects). Scenario inputs for fixed time outcomes unstated.

Response (deferred to amendment). Deferred to the pre-analysis amendment, as you allowed; the matter predates 0.17.0 and adding a new rule now would extend the revision beyond the comments of this round.

F17-5 (minor; Absolute effects). Scenario values on zero count arms are prior dependent.

Response (deferred to amendment). Deferred to the pre-analysis amendment with F17-4 (labeling and display under the sensitivity prior of PR02).

F17-6 (minor; Editorial). Name the relative only rule at its definition; level of the confidence interval; pointer to deferred matters.

Response (revised). Agreed; the defining passage now names the relative only rule, the confidence level is general (C17-1), and the Amendments paragraph points to the comments marked deferred to amendment.

Grok 4.7 (grok-4.7)

No new comments; verdict ACCEPT.

The brief every reviewer received

Peer review round 17: protocol version 0.17.0

You reviewed versions 0.1.0 to 0.16.0 (rounds 1 to 16) of this protocol as reviewer {REVIEWER}. Do NOT edit, create or delete any file.

Read, in the repository root:

  • protocol/peer-review/round-16/review-{REVIEWER}.md (your round 16 review)
  • protocol/peer-review/round-16/response.md (point by point responses to all three reviewers in round 16; yours are the {PREFIX}16- items)
  • protocol/protocol.qmd (version 0.17.0) and the tables it declares authoritative: protocol/populations.csv, outcomes.csv, windows.csv, agents.csv, nodes.csv, node_classes.csv, effect_modifiers.csv, harms_nrs.csv, priors.csv, reference_sd.csv, turner_map.csv, registry_dose_candidates.csv, amendments.csv
  • search/strategies/concepts.yaml (version 1.2.0) and R/search_strategy.R

Tasks:

  1. For each of your round 16 comments, state whether the response and revision resolve it (resolved, partly resolved, not resolved), with a short reason. Where a response declines or partly adopts your proposal with a stated reason, judge the reason.
  2. List any new errors, inconsistencies or non-executable rules introduced by the revision, ordered by severity (major, then minor), with the exact file, section or row, and concrete replacement text or values.
  3. Administrative items that only the review owner can supply (team names, affiliations, funding, competing interests, confirmation of Embase access, PRESS review by a human information specialist, verification of Chinese terms by a Chinese-reading team member, confirmation and locking of provisional thresholds by clinical advisors and patient partners) are tracked as pre-registration conditions in the administrative checklist. Do not withhold acceptance for their absence alone; judge whether the methods are acceptable for registration once they are completed.

Use American English and do not use dashes as sentence punctuation. Keep under 1,500 words.

End with exactly one line: VERDICT: ACCEPT or VERDICT: MINOR REVISION or VERDICT: MAJOR REVISION ACCEPT means you would approve the methods of this protocol for registration once the administrative pre-registration conditions are completed.