| 1 |
Partly verified |
Full text not readStored summary read |
N01 · Comparative efficacyHave the complete-prevention claim, subclaim grade D and parent relapse-reduction grade B been kept separate?Required |
The selected existing claim is ‘Maintenance completely prevents relapse’, with original grade D and a note that 39% relapsed despite maintenance. The parent concerns average relapse reduction, B with 70 points and Caution. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Absent subclaim score, status and axes are not filled with parent values. This is not a new grade assessment. |
Separate preservation of the subclaim wording, grade and note and the parent verdict |
Proposal: Link additional materials while distinguishing complete prevention from average relapse reduction. |
| 2 |
Partly verified |
Full text not readStored summary read |
N02 · Comparative efficacyWhat were the original population's remission, long-term use and consideration of discontinuation conditions?Required |
Participants were adults who felt well enough to consider discontinuation, had at least two previous depressive episodes or at least two years of treatment, and were long-term users. The trial included 150 UK general practices. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. The findings are not automatically applied to other diseases, treatment durations, remission states or populations. Detailed baseline and eligibility tables remain unread. |
Age, remission, previous episodes, treatment history, eligibility and denominators |
Proposal: Obtain original eligibility, baseline characteristics, remission assessment and relapse history. |
| 3 |
Partly verified |
Full text not readStored summary read |
N03 · Comparative efficacyHave the four antidepressants' specific study conditions been extended to all medications?Required |
ANTLER included users of specified doses of citalopram, fluoxetine, sertraline and mirtazapine. Original doses are preserved in the complete existing review summary. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not extend the finding to complete prevention with other medications, doses or patient groups or create instructions for taking, maintaining or discontinuing medication. Original medication-specific denominators and effects remain unread. |
Recording included medications, original study doses, exposure and group composition |
Proposal: Obtain medication-specific inclusion, baseline exposure, denominators and prespecified subgroup materials. |
| 4 |
Partly verified |
Full text not readStored summary read |
N04 · Comparative efficacyWhat was the actual comparison between maintenance and tapering to matching placebo?Required |
The randomized comparison was long-term maintenance versus tapering and switching to matching placebo. The original study's 1~2-month taper is preserved only as a historical condition. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. This is not equated with abrupt discontinuation or every discontinuation method. No new taper schedule, medication instructions or treatment substitution is created. |
Historical interventions, placebo switching, common treatments and actual exposure |
Proposal: Obtain original intervention, placebo, actual exposure, common-treatment and change materials. |
| 5 |
Partly verified |
Full text not readStored summary read |
N05 · Comparative efficacyAre the 478 randomized participants and group-specific absolute relapse denominators preserved?Required |
The 478 participants were allocated to maintenance, 238, or tapering to placebo, 240. Absolute relapse counts were 92/238 versus 135/240. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Two reports of the same trial, multiple medications and other subclaims are not added as new participants. |
Randomization, analysis, group-specific absolute events and follow-up denominators |
Proposal: Obtain original participant flow, allocation, absolute event tables and missing-data mapping by group. |
| 6 |
Partly verified |
Full text not readStored summary read |
N06 · Comparative efficacyDoes the complete-prevention claim agree with the actual maintenance-group events?Required |
The existing review summary and note record relapse within 52 weeks in 92/238 (39%) of the maintenance group. The preserved summary explicitly states that maintenance did not eliminate relapse. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Average reduction is not converted into complete prevention for every person or duration. No new individual prediction or guarantee is made. |
Direct evidence for the selected duration, group, relapse definition and event counts |
Proposal: Link original relapse definitions, ascertainment, events by duration and scope of individual applicability. |
| 7 |
Partly verified |
Full text not readStored summary read |
N07 · Comparative efficacyWhat were the relapse symptom instrument, assessment and ascertainment times?Required |
The preserved summary records relapse assessed with a depression symptom instrument as a patient-important treatment target and analyzes time to first relapse over 52 weeks. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not invent an instrument name, exact diagnostic criteria, measurement schedule or assessor details absent from the original material. |
Instrument, episode definition, ascertainment, measurement times and group denominators |
Proposal: Obtain original relapse definitions, instrument, assessments, ascertainment times and tables. |
| 8 |
Partly verified |
Full text not readStored summary read |
N08 · Comparative efficacyAre 39% versus 56% and the absolute 17%p difference preserved as originally recorded?Required |
Preserve the original wording: maintenance 92/238 (39%) versus discontinuation 135/240 (56%), an absolute difference of 17%p. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. No new proportions, risk differences, RR, NNT, absolute-difference CI or event examples are calculated. Average reduction is not complete prevention. |
Relapsing participants, denominators, original proportions, absolute difference and uncertainty by group |
Proposal: Obtain original absolute-difference, CI, denominator and test materials. |
| 9 |
Partly verified |
Full text not readStored summary read |
N09 · Comparative efficacyAre the discontinuation-versus-maintenance HR direction, CI and P preserved?Required |
The discontinuation-versus-maintenance HR is 2.06 (95% CI 1.56~2.70), P<0.001. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not invert this into a maintenance-versus-discontinuation HR or convert it into a relapse risk ratio or individual complete-protection rate. Detailed model and adjustment variables remain unread. |
Time-to-event effect, comparison direction, CI, test and model |
Proposal: Obtain the original effect of interest, HR direction, model, tests and denominators. |
| 10 |
Partly verified |
Full text not readStored summary read |
N10 · Comparative efficacyAre the 468 participants in the primary time-to-event analysis the same denominator as the 478 for absolute relapse counts?Required |
The 10 participants without relapse timing, 6 maintenance and 4 discontinuation, were excluded from the primary time-to-event analysis but included in absolute relapse counts. The evidence list records 468 participants in the primary analysis. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not change the absolute-event denominator to 468 or newly certify the primary analysis as an all-participant ITT analysis. No new group-specific complete-case counts are calculated. |
Mapping relapse timing, event occurrence, complete-case exclusions and denominators |
Proposal: Obtain original analysis populations, missing timing, group denominators and event mapping. |
| 11 |
Partly verified |
Full text not readStored summary read |
N11 · Comparative efficacyAre the best- and worst-case sensitivity analyses and gaps in effect magnitude retained?Required |
The preserved summary records that sensitivity analyses using best- and worst-case assumptions remained in the same direction. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Consistent direction is not used to certify resolution of all missing-data bias, an exact effect or complete follow-up. Detailed numbers remain unread. |
Missing-data assumptions, omissions by group, sensitivity models, effects and intervals |
Proposal: Obtain original sensitivity-analysis plans, assumptions, effects, intervals and denominators. |
| 12 |
Partly verified |
Full text not readStored summary read |
N12 · Comparative efficacyAre adherence of 70% and 52% and restarting of 39% distinguished from relapse proportions?Required |
Adherence was 70% in maintenance and 52% in discontinuation; 39% of the discontinuation group restarted a clinician-prescribed antidepressant before trial end. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not merge 39% restarting in discontinuation with 39% relapse in maintenance as the same event. No new adherer effects, reasons for restarting or denominators are calculated. |
Actual exposure, adherence definitions, restarting, duration and event relationships |
Proposal: Obtain original exposure, adherence, restarting, timing, event mapping and effects of interest. |
| 13 |
Partly verified |
Full text not readStored summary read |
N13 · Comparative efficacyHas the magnitude of possible withdrawal-versus-relapse misclassification been established?Required |
The preserved summary states that withdrawal symptoms were greater at 12 weeks in discontinuation and possible relapse misclassification could explain some findings, but its magnitude was not established. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not assert that withdrawal explains the entire difference or newly certify that there was no misclassification. |
Distinguishing withdrawal and relapse, measurement, original models and sensitivity analyses |
Proposal: Obtain original withdrawal and relapse definitions, timing, assessment, sensitivity and distinction analyses. |
| 14 |
Partly verified |
Full text not readStored summary read |
N14 · Comparative efficacyHave the original modified DESS means, difference, CI and direction been kept separate?Required |
At 12 weeks, modified DESS was 3.1 in discontinuation versus 1.3 in maintenance, with the original between-group difference 1.9 (95% CI 1.5~2.3). |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not subtract the means again to revise the recorded difference or convert it into a new P, CI, denominator or relapse count. Adjustment and instrument definitions remain unread. |
Withdrawal instrument, time point, group order, original difference, interval and denominators |
Proposal: Obtain original DESS measurements, model, recorded difference, group denominators and repeated time points. |
| 15 |
Partly verified |
Full text not readStored summary read |
N15 · Comparative efficacyHave matching-tablet blinding and limitations of actual allocation guesses been distinguished?Required |
The existing review summary records a double-blind trial using matching tablets, but discontinuation participants guessed allocation better. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Nominal blinding alone does not certify complete actual blinding or resolution of all bias. Guessing proportions and allocation-concealment details remain unread. |
Allocation, concealment, blinding, allocation guesses and analyst procedures |
Proposal: Obtain original blinding, guessing, allocation, measurement and analysis procedures. |
| 16 |
Partly verified |
Full text not readStored summary read |
N16 · Comparative efficacyAre the prespecified first-relapse endpoint, registration and analysis hierarchy actually linked?Required |
The evidence-list endpoint is time to first relapse over 52 weeks, and the registration identifiers are ISRCTN15969819 · EudraCT2015-004210-26. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. No new registration or SAP reading or registration URL construction is performed. Complete prevention is not created as a separate prespecified endpoint of the original trial. |
Registration, protocol, SAP, original primary endpoint, changes and multiplicity plans |
Proposal: Obtain original registration, plans, analysis hierarchy and change history. |
| 17 |
Unverified |
Full text not readStored summary read |
N17 · Comparative efficacyDo gaps in secondary outcomes, medication or baseline-history subgroups and individual prediction remain?Required |
The preserved summary states that the trial did not identify who could discontinue safely. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not create universal protection with maintenance, individual safe discontinuation, medication rankings or baseline-history effects. |
Prespecified subgroups, interactions, denominators, effects and prediction materials |
Proposal: Obtain original subgroup, interaction, individual-prediction and secondary-outcome plans and denominators. |
| 18 |
Partly verified |
Full text not readStored summary read |
N18 · Comparative efficacyIs the relationship to the other claim about 44% without relapse in discontinuation retained?Required |
The existing review summary and sibling subclaim preserve the wording that 44% of the discontinuation group did not relapse within 52 weeks. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. This value is not newly calculated or converted into advice that every person can or cannot discontinue safely. |
Relationships among shared participants, relapse or non-relapse and other subclaims |
Proposal: Link the two subclaims while retaining their relationship to the same trial, duration and denominators. |
| 19 |
Partly verified |
Full text not readStored summary read |
N19 · Comparative efficacyHas the 52-week effect been kept from extending to permanent prevention or other clinical outcomes?Required |
The selected original materials' central duration is 52 weeks, and maintenance participants also relapsed. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. The 52-week reduction is not extended to lifelong absence of relapse, function, quality of life, survival or treatment benefit for every disease. |
Direct outcomes including long-term follow-up, episodes, function and deaths |
Proposal: Obtain direct relapse, clinical-function and long-term outcome materials separately by duration. |
| 20 |
Partly verified |
Full text not readStored summary read |
N20 · Comparative efficacyDo Kato's 40 studies, 8,890 participants and original responses concern the same population as ANTLER?Required |
Kato pooled 40 studies and 8,890 participants from varied post-acute-treatment maintenance-versus-placebo-switch trials. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. This is not treated as the same direct comparison as the real discontinuation decision among long-term primary-care users. Populations, durations and overlap by included trial remain unread. |
Review populations, post-acute maintenance, durations, denominators and trial mapping |
Proposal: Obtain the review's original eligibility, included trials, durations, denominators and relationship to ANTLER. |
| 21 |
Partly verified |
Full text not readStored summary read |
N21 · Comparative efficacyAre review results of 20.9% maintenance versus 39.7% placebo and the OR, CI and P preserved within their original scope?Required |
The review reports maintenance 20.9% versus placebo switch 39.7%, OR 0.38 (95% CI 0.33~0.43), P<0.00001. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Maintenance 20.9% also does not mean complete prevention. The original OR is not converted into ANTLER's HR or an individual protection rate. No new proportions or differences are calculated. |
Pooled relapse effects, group proportions, OR, intervals, tests and denominators |
Proposal: Obtain original pooled models, trial-specific effects, denominators, definitions and heterogeneity. |
| 22 |
Partly verified |
Full text not readStored summary read |
N22 · Comparative efficacyHave NEJM, the detailed NIHR report and the review been kept from being added as new independent trials?Required |
NEJM and NIHR HTA are two reports of the same ANTLER trial. The preserved summary states that the review supports the same direction but was not counted as an independent repeat of the ANTLER question. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Reports, medications, subclaims and the review's 40 studies are not added as new independent trials or participants. Final independent counts and total participant sums remain unrecorded. |
Relationships among original trials, additional reports, pooled materials, shared participants and sibling questions |
Proposal: Link additional reports through original identifiers and preserve relationships among shared populations and included trials. |
| 23 |
Partly verified |
Full text not readStored summary read |
N23 · Comparative efficacyHave gaps in public funding, sponsorship, product supply, affiliations and external analysis been distinguished?Required |
Preserve NIHR HTA 13/115/48, PRIMENT NIHR core support and UCL sponsorship. The preserved summary records that donated trial medication or placebo from a pharmaceutical company was not described in the NEJM or NIHR reports. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Original non-reporting is not converted into certification of no donated supply. Detailed company affiliations and external-analysis roles remain unread. |
Cash support, medication or placebo supply, affiliations, external analysis and design or writing roles |
Proposal: Obtain original support, supply, affiliations, research roles and analysis disclosures separately. |
| 24 |
Partly verified |
Full text not readStored summary read |
N24 · Comparative efficacyIs the original information level for review funding and involvement in included trials retained?Required |
The existing review summary records Japanese Ministry of Health, Labour and Welfare grants H29-SEISHIN-ippan-001 and 19GC1012 for the review. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Review support is not extended to certification that all 40 included studies had public funding, independence or no product supply. |
Review support, funding by original trial, authors and product or analysis roles |
Proposal: Obtain original review and trial-specific support, affiliations, products and analysis relationships. |
| 25 |
Partly verified |
Full text not readStored summary read |
N25 · Supplementary harm evidenceAre serious-adverse-event participant counts, proportions and denominators distinguished from relapse?Required |
Original safety information records serious adverse events in 9 maintenance participants (4%) versus 8 discontinuation participants (3%). |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not convert these into event counts, medication-related harms or statistically significant safety differences. No new differences, P, CI or proportions are calculated. Denominator, collection and relatedness details remain unread. |
SAE definitions, participants versus events, group denominators, relatedness and exposure tables |
Proposal: Obtain original SAE definitions, group-specific events and participants, denominators, relatedness, exposure and discontinuation. |
| 26 |
Partly verified |
Full text not readStored summary read |
N26 · Supplementary harm evidenceHave the original duration and scope of 0 deaths or suicide attempts been distinguished from long-term absence of risk?Required |
Original safety information records 0 deaths and suicide attempts in both groups. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Zero events are not extended to absence of every rare harm, long-term safety or longevity benefit. No new risk CI or numerical examples are created. |
Event definitions, collection, duration, exposure, denominators and rare-harm materials |
Proposal: Obtain original event collection, exposure, denominators, duration and long-term rare-harm materials. |
| 27 |
Partly verified |
Full text not readStored summary read |
N27 · Supplementary harm evidenceDo gaps remain in withdrawal symptoms, other maintenance-treatment harms and discontinuation applicability?Required |
The preserved summary records increased withdrawal symptoms 12 weeks after discontinuation and possible misclassification of some relapse events. The parent safety status is Caution. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Withdrawal is not wholly equated with relapse or maintenance-medication harm. No long-term harm rates or maintenance or discontinuation instructions outside the original materials are created. |
Separate records of withdrawal, medication harms, discontinuation, exposure and long-term follow-up |
Proposal: Obtain original withdrawal, maintenance-medication harm, exposure, discontinuation and long-term materials separately. |
| 28 |
Unverified |
Full text not readStored summary read |
N28 · Supplementary harm evidenceHave repeated harms and applicability to other medications, populations and exposures been kept from new certification?Required |
Current materials compare maintenance with tapering to placebo among particular long-term users in remission; the review concerns varied maintenance trials. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Do not advise an individual to maintain, discontinue, taper or restart medication or certify complete prevention or safety for all medications and populations. |
Direct effects or harms and report relationships by population, medication and duration |
Proposal: Link direct comparisons and harm materials for new populations, medications and exposures separately. |
| 29 |
Partly verified |
Full text not readStored summary read |
N29 · Comparative efficacyAre the summary, three article URLs, registration records and original-material access distinguished?Required |
The complete parent verdict summary was read for production, and three PubMed URLs, original DOIs and registration strings were linked. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. No new URLs are constructed from identifiers. External abstracts, full texts, registrations, protocols and SAP remain unread, with no separate link test. |
Individual bibliography, DOI, summary, external abstracts or full texts and registration or plan records |
Proposal: Link original materials supplied by the user with individual types and actual access status. |
| 30 |
Partly verified |
Full text not readStored summary read |
N30 · Comparative efficacyAre the cutoff date, languages, empty values, original verdict, candidate history and production status preserved?Supplementary |
Preserve 2026-08-26, empty correction and deliberation values, Korean and English drafts, parent B70, Caution and axes, and subclaim grade D. Original review-pending and production-eligibility markers are historical records. |
Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Absent subclaim scores are not filled. Existing content review remains incomplete; review-pending activation and completion markers are false, new units are 0 and the final independent total is unrecorded. |
Distinguishing the complete preserved summary, subclaim record, parent values, corrections and current review |
Proposal: Reflect additional materials and decisions through preservation of original wording and separate events. |