standOff, and the article is at its publisher via the link below. When we have changed our mind. Some entries in the table begin with a word in capitals and the reason for it. EVIDENCE CORRECTED — the finding still stands, but we had quoted the wrong sentence from the paper, and the quotation has been replaced with the right one. RETRACTED — the entry itself was wrong; it stays on the page, marked, with the reason, rather than being deleted. WITHDRAWN AND REPLACED — the entry was wrong, and a corrected version of it appears in the entries below. Each mark carries its own reason, in brackets, because the reasons differ from one entry to the next. An entry we have WITHDRAWN is removed from this page and kept in the record, with its reason. A line reading Audit and a date is a later re-reading of the entry against its whole sentence: DOUBTFUL means it was kept, and the reason says what is loose about it. Quotation marks inside the tagger's sentence. Where a tag is the tagger's own sentence, a phrase in quotation marks inside it is borrowed from the paper — the tagger's wording around it is not. The paper's own sentence is the evidence quote for that row; on this page it is withheld with the article, and the article is at its publisher. Nothing inside quotation marks anywhere on this page is ours: if it is quoted, it is the paper's. Whose words a concept carries. A concept entry records a term the paper itself uses, so the term, the sense given for it, and its evidence are the paper's own words, quoted where the paper fixes them. This is the opposite of a sense entry in the tag table, which is the tagger's sentence about how the paper uses a term. Where a concept entry could not be grounded in the paper's words, the entry says so on its own row.| relation to other work | claim_relations | how this paper stands to another: agrees, contradicts, extends, qualifies |
| claim type | claim_type | the shape of the claim: existence, mechanism, method, critique, prediction, null |
| concept edge | concept_edges | an asserted relation between two concepts, with the sentence asserting it |
| concept | concepts | an idea the paper works with, quoted where the paper uses it |
| content tag | content_tags | a finding, definition, quantity, statistic or variable named in the paper |
| contribution | contribution | what the paper claims to add |
| control | controls | an experiment run to eliminate a rival explanation |
| limitation | limitations | what the paper says its evidence cannot support |
| mechanism | mechanisms | how the reported effect is said to come about |
| method | method | how the paper produced its evidence |
| object of study | object_of_study | what the paper is about — the thing it investigates |
| phenomenon | phenomenon | the effect or regularity under study |
| research question | research_question | the question the paper sets itself |
| sense | senses | a distinct use of a term, quoted where the paper fixes it |
| transfer | transfers | a method or concept carried in from another field |
Relations on this page carry a quotation for the claim. Where a relation was separately evidenced — and so tested against the vocabulary for its type — the row says so; 2 of 2 relations here carry that mark. The rest are the tagger’s reading of the sentence quoted beside them.
| facet | tag | field | conf. | whose words |
|---|---|---|---|---|
| object_of_study | the analysis population of a randomised trial - which subjects are counted when compliance and follow-up fail - and the several incompatible definitions the regulators and the literature give it Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | object_of_study | the paper's words | |
| research_question | what the intention-to-treat principle is, what it buys, what it costs, and where the guidelines disagree about applying it Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | research_question | the paper's words | |
| contribution | assembles the definitions of ITT, per-protocol, modified ITT and the full analysis set side by side with the regulator that issues each, and reports that the modified variant has no consistent definition at all Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | contribution | the paper's words | |
| claim_type | critique Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | claim_type | the paper's words | |
| phenomenon | one analysis population with four names in circulation, each attached to a different regulator, and a modified variant defined case by case Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | phenomenon | the paper's words | |
| method | review Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: review | method | the paper's words | |
| mechanisms | THE DEFINITION IS A TRIPLE REFUSAL TO CONDITION ON ANYTHING THAT HAPPENED AFTER RANDOMISATION - `regardless of their adherence with the entry criteria, regardless of the treatment they actually received, and regardless of subsequent withdrawal from treatment or deviation from the protocol` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | mechanisms[0] | 0.95 | the tagger's words |
| mechanisms | and the reason is that the alternative destroys what randomisation bought: `If noncompliant subjects and dropouts are excluded from the final analysis, it might create important prognostic differences among treatment groups` - and subjects `may be noncompliant or may drop out due to their response of treatment` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | mechanisms[1] | 0.95 | the tagger's words |
| mechanisms | THE COST IS PAID IN THE SAME COIN. `In ITT analysis, estimate of treatment effect is generally CONSERVATIVE because of DILUTION due to noncompliance` - the property that makes it unbiased is the property that makes it small Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | mechanisms[2] | 0.95 | the tagger's words |
| mechanisms | so the criticism is symmetrical: ITT `has been criticized for being too cautious and thus being more susceptible to type II error` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | mechanisms[3] | 0.95 | the tagger's words |
| mechanisms | AND THE TWO POPULATIONS FAIL IN OPPOSITE DIRECTIONS, WHICH IS WHY THE CHOICE IS NOT NEUTRAL. `ITT tends to make the two treatments look similar, whereas the PP removes patients who do not complete treatment and is more able to reflect treatment differences` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | mechanisms[4] | 0.95 | the tagger's words |
| mechanisms | THE MODIFIED VARIANT HAS NO STABLE DEFINITION AT ALL - `the definition given to the modified ITT (mITT) in randomized controlled trial has been found to be irregular and arbitrary because there is a lack of consistent guidelines for its application. The mITT analysis allows a subjective approach in entry criteria` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | mechanisms[5] | 0.95 | the tagger's words |
| mechanisms | and it is not one population but many: `multiple mITT populations can be defined for a single study such as clinical mITT and microbiological mITT` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | mechanisms[6] | 0.95 | the tagger's words |
| mechanisms | THE SAME OBJECT CARRIES A THIRD NAME FROM A THIRD AUTHORITY - ICH E9 `uses the term FULL ANALYSIS SET to describe the analysis set which is as complete as possible and as close as possible to the ITT ideal` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | mechanisms[7] | 0.95 | the tagger's words |
| limitations | The guidelines do not agree about where the principle applies. `Whereas the importance of the ITT population analysis in superiority designs has been well accepted, however there is no consensus about its role in non-inferiority trials` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | limitations[0] | 0.95 | the tagger's words |
| limitations | and the proposed resolution is to require both and hope they agree - `noninferiority should be concluded only if both ITT and PP analyses permit that` - which is a procedure rather than a principle, and the paper notes the conservative effect of PP on such trials `has not been thoroughly explored` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | limitations[1] | 0.95 | the tagger's words |
| limitations | the remedy offered for the missing data ITT cannot ignore is itself contested - last observation carried forward, `whereby the LAST AVAILABLE MEASUREMENT for each individual at the time point prior to withdrawal IS RETAINED in the analysis`, presented here without its known bias Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | limitations[2] | 0.85 | the tagger's words |
| limitations | This is a narrative review for beginners, not a systematic one. No search strategy, no inclusion criteria and no synthesis are reported; the claims about what the literature finds - including the central one about mITT - are carried by citation Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | limitations[3] | 0.85 | the tagger's words |
| limitations | and the practical advice at the end withdraws the problem rather than solving it: `Anyone who follows these principles intelligently and has a vision to minimize bias should not worry further about 'INTENTION TO TREAT'` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | limitations[4] | 0.95 | the tagger's words |
| transfers | intention-to-treat is a statistical concept imported into the conduct and reporting of randomized controlled trials to handle noncompliance and missing outcomes Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | transfers[0] | 0.95 | the tagger's words |
| transfers | the analysis set is defined by the randomized assignment rather than by the treatment actually received, which is what preserves the randomization Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | transfers[1] | 0.95 | the tagger's words |
| controls | randomisation itself - allocating subjects to arms after eligibility is assessed but before the intervention is given Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. eliminates: systematic difference between the groups at baseline; ITT exists to protect this and per-protocol analysis is what spends it · outcome: held | controls[0] | 0.95 | the tagger's words |
| controls | requiring full reporting of every deviation from random allocation and every missing response, as CONSORT does Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. eliminates: an ITT label attached to an analysis whose exclusions the reader cannot see; the guideline makes the departures visible rather than forbidding them · outcome: held | controls[1] | 0.95 | the tagger's words |
| controls | requiring the ITT and per-protocol analyses to agree before a non-inferiority claim is made Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. eliminates: a conclusion that depends on which population was chosen - the two are known to fail in opposite directions, so agreement between them is informative · outcome: partial | controls[2] | 0.95 | the tagger's words |
| concepts | intention-to-treat Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: intention-to-treat | concepts[0] | 0.95 | the paper's words |
| concepts | ITT analysis Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: ITT analysis | concepts[1] | 0.95 | the paper's words |
| concepts | per-protocol Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: per-protocol | concepts[2] | 0.95 | the paper's words |
| concepts | modified ITT Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: modified ITT | concepts[3] | 0.95 | the paper's words |
| concepts | full analysis set Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: full analysis set | concepts[4] | 0.95 | the paper's words |
| concepts | noncompliance Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: noncompliance | concepts[5] | 0.95 | the paper's words |
| concepts | prognostic balance Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: prognostic balance | concepts[6] | 0.95 | the paper's words |
| concepts | type II error Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: type II error | concepts[7] | 0.95 | the paper's words |
| concepts | sample size Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: sample size | concepts[8] | 0.95 | the paper's words |
| concepts | last observation carried forward Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: last observation carried forward | concepts[9] | 0.95 | the paper's words |
| concepts | noninferiority Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: noninferiority | concepts[10] | 0.95 | the paper's words |
| concepts | superiority trial Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: superiority trial | concepts[11] | 0.95 | the paper's words |
| concepts | heterogeneity Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: heterogeneity | concepts[12] | 0.95 | the paper's words |
| senses | `intention-to-treat` (Fisher et al. 1990) - all randomised patients in their assigned groups, `regardless of their adherence with the entry criteria, regardless of the treatment they actually received, and regardless of subsequent withdrawal` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | senses[0] | 0.95 | the tagger's words |
| senses | `intention-to-treat` (the slogan) - `once randomized, always analyzed` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | senses[1] | 0.95 | the tagger's words |
| senses | `full analysis set` (ICH E9) - the analysis set `as complete as possible and as close as possible to the ITT ideal` - the same object under a third name Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | senses[2] | 0.95 | the tagger's words |
| senses | `modified ITT` - a subset with exclusions `in a justified way`, whose definition the literature finds `irregular and arbitrary` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | senses[3] | 0.95 | the tagger's words |
| senses | `ITT` as a whole-trial strategy - `better regarded as a complete trial strategy for design, conduct and analysis rather than as an approach to analysis alone` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | senses[4] | 0.95 | the tagger's words |
| claim_relations | critiques → the modified ITT population as used in randomised trials, whose definition the paper reports as irregular, arbitrary and lacking consistent guidelines Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | claim_relations[0] | 0.95 | the tagger's words |
| claim_relations | supports → the CONSORT requirement that participants be analysed by the intention-to-treat principle and that deviations be fully reported Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | claim_relations[1] | 0.95 | the tagger's words |
| claim_relations | concedes → that ITT dilutes the treatment effect and is more susceptible to type II error - the arguments against it 'appear valid' Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | claim_relations[2] | 0.95 | the tagger's words |
| concept_edges | ITT analysis —distinct-from→ per-protocol Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. the relation itself is separately evidenced · strength of the relation: 0.95 · note: 'ITT tends to…' Not two views of one number - two numbers, and the analyst picks which before seeing either. · the relation stated: ITT keeps the noncompliers and dilutes the difference; per-protocol removes them and shows it - so the choice of population moves the answer, in a direction that is known in advance also in: ITT analysis · per-protocol | concept_edges[0] | 0.95 | the tagger's words |
| concept_edges | superiority trial —distinct-from→ noninferiority Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. the relation itself is separately evidenced · strength of the relation: 0.95 · note: 'WHEREAS the importance…' The same method, the same population, and its authority is a property of the question being asked - which is why 'use ITT' is not an instruction. · the relation stated: ITT's standing depends on what the trial is trying to show: settled as primary in a superiority design, unsettled in a non-inferiority one
Audit 2026-09-28: DOUBTFUL - read against its full span and kept, but the span writes 'non-inferiority', and the ITT role differs between the two designs; distinct-from is loose. also in: superiority trial · noninferiority | concept_edges[1] | 0.95 | the tagger's words |
| content_tags | THE DEFINITION IS A TRIPLE `regardless of` - all randomised patients in their assigned groups `regardless of their adherence with the entry criteria, regardless of the treatment they actually received, and regardless of subsequent withdrawal` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | content_tags.findings[0] | 0.95 | the tagger's words |
| content_tags | AND IT HAS A SLOGAN THAT IS SHORTER THAN THE DEFINITION - ITT analysis `is usually described as once randomized, always analyzed` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | content_tags.findings[1] | 0.95 | the tagger's words |
| content_tags | THE MODIFIED VARIANT'S DEFINITION IS IRREGULAR AND ARBITRARY, AND THE PAPER SAYS SO - `there is a lack of consistent guidelines for its application. The mITT analysis allows a subjective approach in entry criteria, which may lead to confusion, inaccurate results and bias` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | content_tags.findings[2] | 0.95 | the tagger's words |
| content_tags | AND ONE STUDY CAN HOLD SEVERAL OF THEM - `multiple mITT populations can be defined for a single study such as clinical mITT and microbiological mITT` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | content_tags.findings[3] | 0.95 | the tagger's words |
| content_tags | ICH E9 calls it the full analysis set: as complete as possible and as close as possible to the ITT ideal Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | content_tags.findings[4] | 0.95 | the tagger's words |
| content_tags | ITT tends to make treatments look similar, while per-protocol analysis better reflects treatment differences Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | content_tags.findings[5] | 0.95 | the tagger's words |
| content_tags | ITS AUTHORITY DEPENDS ON THE QUESTION - settled as primary in superiority designs, and `there is no consensus about its role in non-inferiority trials` Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | content_tags.findings[6] | 0.95 | the tagger's words |
| content_tags | ITT analysis Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: ITT analysis | content_tags.definitions[0] | 0.95 | the tagger's words |
| content_tags | full analysis set Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: full analysis set | content_tags.definitions[1] | 0.95 | the tagger's words |
| content_tags | modified ITT Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: modified ITT | content_tags.definitions[2] | 0.95 | the tagger's words |
| content_tags | last observation carried forward Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: last observation carried forward | content_tags.definitions[3] | 0.95 | the tagger's words |
| content_tags | complications ITT exists to absorb Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | content_tags.quantities[0] | 0.95 | the tagger's words |
| content_tags | ITT `gives an unbiased estimate of treatment effect` and its estimate `is generally CONSERVATIVE because of DILUTION due to noncompliance`. Both sentences are true and they describe one mechanism - keeping the noncompliers is what preserves the randomisation and what shrinks the difference. A reader who quotes either alone has quoted half of it. Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. | content_tags.statistics[0] | 0.95 | the tagger's words |
| content_tags | analysis population Quotation withheld — this record is not cleared for redistribution. The sentence is in the paper at the link above. also in: analysis population | content_tags.variables[0] | 0.95 | the tagger's words |
Tags that could not be placed in the text:
What was deliberately not tagged, and why, is recorded per paper by the tagger. Where a paper has no such record, this page says so rather than implying that nothing was declined.