Establishing an evaluation index system of nursing quality for clinical drug trials: A Delphi study.
Junyi Chen, Huiyu Zhou, Qingxiu Mai and 8 others
PMID 37680014WHAT IT FOUND
A Delphi consensus among 18 Chinese experts established a framework to assess nursing quality in clinical drug trials, prioritizing staff training, adverse reaction management, and accurate record-keeping.
The system is not yet validated in practice.
Key findings
01The evaluation system prioritizes nursing staff education and training, with first aid and protocol training receiving the highest weights among structural indicators.
02In process quality, managing new drug adverse reactions carries the greatest weight, specifically the correct emergency treatment of allergic reactions.
03Outcome quality emphasizes subject-related results, with extravasation incidence, home medication accuracy, and pharmacokinetic blood collection compliance tied for the highest combined weight.
STILL TO COME
How it was doneWhat they foundWhat it means for RNs
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What it does not show
The evaluation system has not been applied in clinical practice, so its real-world utility and reliability are untested. Experts were drawn from only 12 hospitals in five Chinese provinces, which may limit the generalizability of the indicators to other healthcare systems. The study relies on expert opinion and consensus rather than empirical data on patient outcomes.
Declared interests
The study was funded by the Medical Science and Technology Research Fund in Guangdong Province of China. The authors declared no conflicts of interest.
The easy way to misread this
Do not use this index to assess general nursing quality or patient outcomes in non-trial settings. It is a proposed framework for clinical drug trial management that has not yet been validated in practice.