<p>Ethics of conducting the study "Oral 24% sucrose associated with nonnutritive sucking for pain control in healthy term newborns receiving venipuncture beyond the first week of life" [Letter]</p>
Bibliographic record
Abstract
We refer to the pilot study by De Bernardo et al, 1 in which 66 healthy infants were randomized to 24% sucrose or 10% glucose during venipuncture.Findings were 24% sucrose statistically significantly reduced pain compared to 10% glucose.This is not surprising as the efficacy of sweet tasting solutions in reducing pain in newborn infants has been known since the early 2000s, 2 and less concentrated solutions, including the 10% glucose used in this study had already been shown to be ineffective.Therefore, this trial, which studied an already known effective intervention compared to an already known ineffective intervention, does not comply with the principle of equipoise.2,3 Clinical research trials require equipoise, defined as "a state of genuine uncertainty on the part of the clinical investigator regarding the comparative therapeutic merits of each arm in a trial".3 This requires that the investigator is fully aware of the current knowledge regarding benefits of intervention and control arms and existing knowledge gaps before planning a trial.Unfortunately, it is evident the authors were not aware of the knowledge concerning analgesic effects of sweet solutions before they commenced their study.The authors state "The study was conducted in accordance with the Declaration of Helsinki".However, this implies that: "Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature…".4 As stated earlier, this had obviously not occurred as evidenced by the omission in the reference list of key systematic reviews on the topic.Another concern with this paper relates to parental informed consent.The authors stated that informed consent from the families was obtained.However, were parents truly informed about the study?Were they informed of the fact that there was already abundant evidence to support 25% sucrose during venipuncture?Were they informed about analgesic effects of other strategies they could use during their infants' venipuncture, such as breastfeeding? 5 Engaging with and involving parents of hospitalized infants from the beginning of the study may have resulted in more relevant research being conducted.In conclusion, extensive research conducted over the past two decades has clearly demonstrated that sweet solutions, if sufficiently sweet, reduce acute
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.009 | 0.033 |
| Meta-epidemiology (narrow) | 0.000 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.015 | 0.015 |
| Insufficient payload (model declined to judge) | 0.026 | 0.013 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".