A selected record and an original worked study

2014

Trial Denominators: People and Time

Compare first-event risk with first-event rates in an invented follow-up ledger, then identify what information is lost when recurring events are combined.

Invented equal participant counts but unequal person-time, yielding rates 20 and 10 per 100 person-years.
10%
Both invented affected-person proportions
20 / 10
Invented rates per 100 person-years
50%
Invented relative rate reduction

The short answer

A numerator becomes interpretable only after its unit and observation window are specified. This study reads a concrete trial definition, then uses fictional cohorts to separate people from follow-up time.

Record comparison

The units prevent substitution

Keep the historical record distinct from the stipulated model.

All numerical fixtures below are invented unless explicitly labelled historical.
QuestionRecord or stipulated inputConsequence and limit
Risk-like proportion10 affected people/100 participants10% in both invented groups.
First-event rate10 events/50 or 100 person-yearsDifferent rates despite equal counts.
Recurrent eventsA different numerator and exposure ledgerCannot silently reuse first-event follow-up.

Chronology

A timeline of the turning points

  1. Trial report

    The selected analysis definitions were published.

The report defines its comparison

The selected 2014 report distinguishes per-protocol and intention-to-treat populations. Its efficacy calculation compares first-event rates using person-time, counting only each participantโ€™s first qualifying event and ending that participantโ€™s relevant follow-up at the event or another endpoint.

These definitions prevent an affected-person count from being silently substituted for all episodes. They also explain why a comparison of proportions and one of event rates can answer different questions. No current clinical recommendation follows from this historical analysis definition.

Sources for this section: [1]

An invented follow-up ledger

Invent two nonclinical observation groups, each with 100 participants and 10 first events. Group A contributes 50 person-years before its first-event or censoring endpoints; group B contributes 100 person-years. Assume complete event ascertainment and treat the supplied totals as exact.

Compute the affected-person proportion in each group, the first-event rate per 100 person-years, and the relative rate reduction of B compared with A. Then ask whether the same quantities can be obtained from ten affected people alone without the follow-up totals.

Sources for this section: [1]

Reference answer

Both proportions are 10/100=10%. The rates are 10/50ร—100=20 and 10/100ร—100=10 per 100 person-years. The B-to-A rate ratio is 0.5, giving an arithmetic relative rate reduction of 50%. The equal proportions do not remove the difference in accumulated observation time.

Now invent 5 additional recurrent events among the same affected people. The first-event numerator remains 10. An all-episode numerator would be 15 and would require a consistently defined all-episode observation period. Dividing 15 by the original first-event person-time would mix incompatible definitions.

Sources for this section: [1]

Selection and uncertainty remain

The arithmetic is not a causal inference about a treatment. The fixture supplies neither a randomisation process nor uncertainty intervals, competing-event information or follow-up distributions. It is an accounting exercise.

The historical reportโ€™s named populations and event rules make its result a defined comparison. A reader should preserve those rules when discussing a published percentage, instead of treating that percentage as a timeless property applying to every person and period.

Sources for this section: [1]

Continue the chronology

Biography context

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Connected biographies

The working life behind the record

Quick answers

Common questions

Is the 50% answer a vaccine-effectiveness estimate?
No. It is an invented nonclinical rate comparison.
Does a person-year mean one person was followed for exactly one year?
No. It is accumulated observation time; many individual follow-up patterns can produce the same total.

Primary and institutional sources

How this history was checked

Selected records support the historical discussion. Invented inputs and original answers are labelled; no complete uninspected work is claimed. This article was reviewed on 31 October 2026.

  1. Nita Bhandari, Temsunaro Rongsen-Chandola, Ashish Bavdekar, Jacob John, Gagandeep Kang and colleagues, Lancet 383, 2136โ€“2143, 2014Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial