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Table 1 Reproducibility framework, terms, and definitions

From: Reproducibility of clinical research in critical care: a scoping review

Reproducibility component

Definition

Unique clinical practice

A specific intervention applied to patients with a specific target condition (e.g., therapeutic hypothermia for patients with traumatic brain injury)

Reported effect of clinical practice

 Efficacy

For the primary outcome, statistically significant increased risk of a positive outcome, or decreased risk of a negative outcome

 Harm

For the primary outcome or any pre-specified secondary or safety outcome, statistically significant increased risk of a negative outcome, or decreased risk of a positive outcomea

 Lack of efficacy

For the primary outcome, a non-statistically significant change

Type of results reproducibility [12]

 Re-test reproduction attempt

For a given clinical practice, a study that re-examined the results of an original study in another group of participants using methodology identical to that of the original studyb

 Approximate reproduction attempt

For a given clinical practice, a study that re-examined the results of an original study in another group of participants using methodology with minor changes to the population, setting, treatment, outcomes, and/or analyses relative to the original studyb

Reproducibility classification

 Original study

First randomized controlled trial to examine the effects of a clinical practicec

 Reproduction attempt

Re-test or approximate reproduction attempt for an original study

 Consistent effect estimate between original study and reproduction attempt

Clinical practice effect reported in the reproduction attempt was congruent with that in the original study:

- Efficacy/efficacy

- Lack of efficacy/lack of efficacy

- Harm/harm

 Inconsistent effect estimate between original study and reproduction attempt

Clinical practice effect reported in the reproduction attempt was different from that in the original study:

- Efficacy/harm

- Efficacy/lack of efficacy

- Harm/lack of efficacy

- Harm/efficacy

- Lack of efficacy/harm

- Lack of efficacy/efficacy

  1. aWhere there was a significant positive effect for the primary outcome, and a significant negative effect for a safety outcome, practice classification was based on the relative importance of each outcome. For example, if survival was improved, but there was an increased incidence of adverse drug reaction, the practice was classified as having efficacy
  2. bSample size of reproduction attempt was required to be at least 90% that of the original study [14]
  3. cEarly phase trials did not count as an original study; these were defined as those for which the main objective was to evaluate the feasibility of processes (recruitment, randomization, blinding, outcome assessment, etc.) required to examine the effect of the clinical practice in a later phase clinical trial [53]
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BMC Medicine

ISSN: 1741-7015

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