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Retractions in the medical literature: how can patients be protected from risk?
1MediCC! Medical Communications Consultants, Chapel Hill, NC 27517, USA. g_steen_medicc@yahoo.com
Background:
Medical research so flawed as to be retracted may put patients at risk by influencing treatments.
Objective:
To explore hypotheses that more patients are put at risk if a retracted paper appears in a journal with a high impact factor (IF) so that the paper is widely read; is written by a 'repeat offender' author who has produced other retracted research; or is a clinical trial.
Methods:
English language papers (n=788) retracted from the PubMed database between 2000 and 2010 were evaluated. Only those papers retracting research with humans or freshly derived human material were included; 180 retracted primary papers (22.8%) met inclusion criteria. Subjects enrolled and patients treated were tallied, both in the retracted primary studies and in 851 secondary studies that cited a retracted primary paper.
Results:
Retracted papers published in high-IF journals were cited more often (p=0.0004) than those in low-IF journals, but there was no difference between high- and low-IF papers in subjects enrolled or patients treated. Retracted papers published by 'repeat offender' authors did not enrol more subjects or treat more patients than papers by one-time offenders, nor was there a difference in number of citations. However, retracted clinical trials treated more patients (p=0.0002) and inspired secondary studies that put more patients at risk (p=0.0019) than did other kinds of medical research.
Conclusions:
If the goal is to minimise risk to patients, the appropriate focus is on clinical trials. Clinical trials form the foundation of evidence-based medicine; hence, the integrity of clinical trials must be protected.
Insights
Flawed medical research retractions pose patient risks. Retracted clinical trials, more than other research, put more patients at risk and influence further studies.
Area of Science:
- Medical research integrity
- Patient safety
- Scientific publishing
Background:
- Retracted medical research can negatively impact patient treatment and safety.
- The extent of patient risk from retracted studies is not fully understood.
Purpose of the Study:
- To investigate if retracted papers in high impact factor journals, authored by repeat offenders, or being clinical trials, increase patient risk.
- To quantify patient exposure in retracted studies and their citations.
Main Methods:
- Analysis of 180 retracted primary research papers involving human subjects published between 2000-2010.
- Evaluation of patient numbers in primary retracted studies and 851 citing secondary studies.
- Comparison of risk factors including journal impact factor, author history, and study type (clinical trial vs. other).
Main Results:
- Retracted papers in high impact factor journals received more citations but did not involve more patients.
- Authors with previous retractions did not lead to more patients being enrolled or treated.
- Retracted clinical trials involved significantly more patients and led to more at-risk secondary studies.
Conclusions:
- Clinical trials represent a critical area for ensuring research integrity due to their direct impact on patient risk.
- Protecting the integrity of clinical trial research is paramount for safeguarding patient safety in evidence-based medicine.
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