A crisis faces healthcare from an unsuspected source. There is an insidious threat to our ability to care for patients that stems from our system of research, publication, and evaluation of information used in healthcare decision making. For those in academic healthcare, there is tremendous pressure to publish research to further one's career. At the same time, medical and nursing journals must publish studies that are attention-grabbing in order to remain in print. The combination of these forces has allowed publication of poorly designed, biased, and even falsified studies in the interest of creating bombastic and sensational headlines. This comes at great cost to society in weakening our ability to evaluate the reliability of medical information and may erode the patient and family's trust in our competence to provide evidence-based and effective care.
A recent study provides evidence for this bias in the healthcare literature.1 The authors collaborated to reproduce 100 experimental and correlational studies in well-regarded psychology journals using designs with high statistical power and original materials, when available. While 97% of the original studies had statistically significant results, only 36% of the replicated studies were significant. In addition, most of the original effect sizes were not in the 95% confidence interval of the replication effect size. In other words, the data in most of the replicated studies did not support the conclusions made in these well-regarded original studies. While the methods and meaning of this research are being debated,2-3 this work underlines an important concept. In order for research to be valid, a study's findings must be reproducible. In my opinion, there is resistance among researchers and publishers to pursue publication of replicated studies. It is difficult for both parties to gain prestige by publishing a study similar to what has been published in the past, especially if the conclusions are the same as "what we already know."
Questioning the accuracy of published medical research is a growing area of academic endeavor. Dr John Ioannidis, an innovator in this field, published an essay entitled "Why Most Published Research Findings Are False," detailing his analysis that "a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance."4(pe124) His assertion that for most study designs a research finding is more likely to be false than true is debated in the literature. Nevertheless, there is a growing momentum toward questioning the methods and veracity of healthcare research, including studies published in prestigious journals with rigorous peer-review processes. The Appendix summarizes 10 principles that, in my opinion, are essential to the design, execution, publication, and evaluation of research in healthcare.
SUMMARY
The principles of accurate and reproducible clinical research are challenging. Positive publication bias and the career-advancement forces underlying it will be present until there is greater accolade for studies with negative results, both from peer-reviewed journals and academic institutions. We must embrace the fact that most well-designed studies will have negative results and recognize that this is essential to expanding the evidence base that underlies daily clinical decision making. In addition, the regulatory burden and cost of well-designed research continue to increase while funding and dedicated research time for most clinical research have decreased in many health care fields, including nursing and medicine. Nonetheless, these are challenges that must be met because high-quality research is essential to the advancement of the practice of all healthcare fields. Pursuit of scientifically sound research will ultimately yield better patient outcomes and enhance public trust in our ability to provide effective patient care.
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