Informed consent when prescribing medication: A randomized controlled trial
Bibliographic record
Abstract
OBJECTIVES/HYPOTHESIS: To determine patient recall of specific risks associated with medication prescription and whether or not handouts are an effective tool to augment the informed consent process. STUDY DESIGN: Double-blinded, randomized, controlled trial. METHODS: Informed consent for prednisone prescriptions was studied by comparing the effect of a verbal discussion (describing 10 specific adverse drug reactions) in conjunction with a handout going over same, to a verbal discussion alone. Blinded assessments occurred by telephone interview 2 to 4 weeks following the intervention. Outcomes assessed were the number of risks of prednisone that patients could list and the number of risks they recalled having discussed with their physician. Other demographic details were also collected. RESULTS: Twenty-five participants were randomly allocated to each group. Without prompting, the median number of risks spontaneously recalled by the handout group was not significantly different than the control group, and both groups had very low recall (two vs. one, P = .24). When provided a list of potential side effects, it was observed that the handout group recalled a higher median number of risks having been discussed with their physician compared to patients in the control group (eight vs. five, P = .003). The groups' demographics were otherwise identical. CONCLUSIONS: Patients in general did not remember discussing adverse prednisone risks with their physician even a short time after the discussion took place. Although the patient handout resulted in improved recall of risks following the prescription of prednisone, its importance in the informed medication consent process remains an open question. LEVEL OF EVIDENCE: 1b.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.016 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 0.003 |
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; both teacher heads agree on what is shown here.
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".