# PROSPERO Submission Audit — 2026-05-14

**Project:** Axillary management after NAC in cN+ breast cancer — umbrella review
**Lead reviewer (audit):** David Duque
**Status of package:** READY FOR SUBMISSION pending the items below
**Files audited:**
- `PROSPERO_submission_form_FINAL.txt`
- `PROSPERO_protocol.md`
- `search_strategy_pilot.md`
- `SERGIO_CHECKLIST_before_submission.md`
- `cover_email_to_coauthors.md`

---

## 1. Executive risk summary

| Tier | Items | Avg. risk | Submission-blocking? |
|---|---|---|---|
| Tier 1 — Sergio personal info | 6 fields | LOW (you fill in 30 min) | YES — cannot submit without |
| Tier 2 — Co-author recruitment | 2 slots | MEDIUM (depends on response time) | NO — can submit with TBC and amend later |
| Tier 3 — Institutional/legal | 0 fields | NONE (umbrella reviews exempt) | N/A |
| **Net assessment** | **8 items** | **Submittable within 2 weeks if Sergio prioritises Tier 1.** | |

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## 2. Detailed inventory of remaining `[NEEDS SERGIO INPUT]` markers

### 2.1 Tier 1 — Sergio personal info (6 fields, LOW risk)

| Field # | Item | Source | Risk | Mitigation |
|---|---|---|---|---|
| 6 | Institutional email | Sergio | LOW | Use professional email currently in use. |
| 6 | Postal address | Sergio | LOW | Hospital/department address. |
| 6 | Telephone (international format) | Sergio | LOW | Centralita is acceptable; PROSPERO never publishes phone publicly. |
| 6 | ORCID iD | Sergio (or new account) | LOW | If none, register at https://orcid.org in <5 min. Optional but strongly recommended. |
| 7 | Contact email (duplicate of Field 6) | Sergio | LOW | Same as Field 6. |
| 30 | Country of corresponding author | Sergio | LOW | Single word ("Spain"). |

**Net Tier 1 risk:** LOW. **Critical timeline:** all six can be filled in a single 30-min sitting. **Recommendation:** Sergio should complete these BEFORE 2026-05-21 to keep the PROSPERO submission on the W21 deadline.

### 2.2 Tier 2 — Co-author recruitment (2 slots, MEDIUM risk)

| Slot | Item | Source | Risk | Mitigation |
|---|---|---|---|---|
| 9.3 | Biostatistician name + affiliation | External recruitment | MEDIUM | Submit PROSPERO with `[to be confirmed]`; amend within 4 weeks. Send 3 invitations in parallel (see `cover_email_to_coauthors.md`) to maximise response speed. |
| 9.4 | Senior breast surgeon name + affiliation | External recruitment | MEDIUM | Same strategy. Sergio's professional network likely yields a candidate within 2 weeks. |

**Net Tier 2 risk:** MEDIUM with the following decomposition:
- **If Sergio sends invitations the same week as PROSPERO submission (W20-W21):** expect first responses by W22, consolidation by W24. PROSPERO ID typically arrives W26-W28; ample time to add co-authors by amendment before manuscript submission.
- **If Sergio delays invitations to wait for PROSPERO ID first:** project loses 4-6 weeks; amendment may not be in place when manuscript is submitted to journal in Q4 2026. **NOT RECOMMENDED.**

**Specific risk scenarios:**
- *Risk A* — biostatistician slot unfilled by 2026-06-15: MODERATE. May delay manuscript by 2-4 weeks because formal analysis cannot start. **Mitigation:** Sergio cascades invitations to 3+ candidates in W20.
- *Risk B* — senior breast surgeon slot unfilled by 2026-07-01: LOW. Surgical perspective can be incorporated by D.D. + S.C. internally for the draft, with sénior surgeon added as reviewer pre-submission. **Mitigation:** keep the slot open without blocking.

### 2.3 Tier 3 — Institutional / legal clearances

**No items required.** Confirmed via review of documentation:
- Umbrella review uses only published, aggregated data → no IRB/CEIm required (RD 1090/2015 exempts data-only secondary research).
- No consent-form requirements (no human subjects, no biospecimens).
- No data-protection impact assessment needed (no personal data processed).
- No conflict-of-interest sign-offs required beyond the COI statement already in Field 11.

---

## 3. Quality-control verification (already passed)

- [x] Title under 200 characters (174) — OK
- [x] Question under 500 characters (491) — OK
- [x] Numbers consistent with paper state (23 included = 13 ELIGIBLE + 10 BORDERLINE; 10 excluded with PICOS rationale in Supp S4) — OK
- [x] Stage of review accurately reflects current state ("Preliminary searches AND pilot data extraction completed") — OK
- [x] COI declaration explicit on D.D. tool ownership and revenue absence — OK
- [x] Funding declaration ("None") consistent across all documents — OK
- [x] Search dates consistent (2006-01-01 to 2026-04-30) across form, protocol, and search_strategy_pilot — OK
- [x] Languages consistent (EN/ES/FR) across form and protocol — OK
- [x] Outcome list matches protocol §2 (ypN0, FNR primary; IR, recurrence, OS, DFS, lymphedema, PRO additional) — OK
- [x] Subgroup analyses match protocol §3.5 with the addition of AMSTAR-2 tier sensitivity — OK
- [x] Attachment list explicit (S1 + S2) — OK
- [x] All UTF-8 tildes correctly rendered in Spanish documents — OK

---

## 4. Decision matrix for Sergio (Y/N format)

| Question | Answer | Action |
|---|---|---|
| Can Sergio submit PROSPERO without his ORCID? | Y | But strongly recommend register one in 5 min. |
| Can Sergio submit PROSPERO without confirmed bioestadístico? | Y | Use `[to be confirmed]` and amend later. |
| Can Sergio submit PROSPERO without confirmed senior breast surgeon? | Y | Same. |
| Does Sergio need IRB/CEIm approval before submitting PROSPERO? | N | Umbrella review exempt. |
| Does Sergio need to provide his hospital affiliation as the host institution? | N | "Independent academic project (Cervera SC, Duque DD)" already stated; institution is optional and can be added by amendment. |
| Does Sergio need to wait for the biostatistician to confirm before sending? | N | NOT recommended — would lose 4-6 weeks. Submit with TBC and recruit in parallel. |
| Will the PROSPERO ID change if Sergio adds co-authors later by amendment? | N | The ID is permanent. Amendments append to the same record. |
| Should D.D. (David Duque) be the named contact instead of Sergio? | N | Sergio is PI per agreed roles. Contact = PI by convention. |

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## 5. Recommended action sequence (next 14 days)

| Date | Action | Owner | Estimated time |
|---|---|---|---|
| 2026-05-14 | Sergio reads `SERGIO_CHECKLIST_before_submission.md` | SC | 10 min |
| 2026-05-15 | Sergio fills Tier 1 items in `PROSPERO_submission_form_FINAL.txt` | SC | 30 min |
| 2026-05-15 | Sergio drafts and sends 3 biostatistician invitations using template | SC | 30 min |
| 2026-05-16 | Sergio drafts and sends 2 senior surgeon invitations | SC | 20 min |
| 2026-05-18 | Sergio creates PROSPERO account and enters draft | SC | 60 min |
| 2026-05-21 | Sergio submits PROSPERO with TBC slots | SC | 15 min |
| 2026-W22-W24 | Co-author responses arrive | passive | — |
| 2026-W26-W28 | PROSPERO ID issued | passive | — |
| 2026-W28+ | Amend PROSPERO with confirmed co-authors | SC | 15 min |

**Total Sergio time investment: ~3 hours over 14 days. Critical path: Tier 1 fields by 2026-05-21.**

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## 6. Open questions for Sergio (please answer in next reply)

1. **Affiliation declaration preference:** "Independent academic project" (current) OR named hospital/department as host? (Either is fine; named hospital adds visibility.)
2. **Country field:** confirm "Spain" is correct.
3. **Authorship order on the eventual manuscript:** confirm Cervera (1st, PI) — Duque (2nd, data lead) — Biostatistician (3rd) — Senior surgeon (last, senior author). Standard order; flag now if you want to adjust.
4. **Preferred journals (Field 33):** the form lists BJS, ESMO Open, EJSO, The Breast, Annals Surg Onc. Confirm priority order or modify.

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**End of audit.**
