bioRxiv preprint first posted online May. 4, 2017; doi: http://dx.doi.org/10.1101/133926
Research Waste in ME/CFS
Sonia Lee
Sydney School of Public Health, University of Sydney, Australia
Abstract
Objective:
To compare the prevalence of selective reporting in ME/CFS research areas: psychosocial versus cellular.
Method:
A bias appraisal was conducted on three trials (1x psychosocial and 2x cellular) to compare risk of bias in study design, selection and measurement. The primary outcome compared evidence and justfications in resolving biases by proportions (%) and ORs (Odds Ratio); the secondary outcome determined the proportion (in %) of ME/CFS grants at risk of bias.
Results:
NS (cellular study) was twice as likely to present evidence in resolving biases over PACE (psychosocial trial) (OR = 216; 656% vs 469%), but this difference was not signifficant (p = 013). However, NS was ve times more likely to justify biases over PACE (OR = 476; 469% vs 156%) and this difference was significant (p = 00095; p < 005). PACE was weak in place (operational aspects 32%) and NS for data practices (37%). The proportion of grants were more biased in evidence for PACE (72%) compared to NS (28%), and also more biased in justifications for PACE (86%) than NS (14%).
Conclusion:
Psychosocial trials on ME/CFS are more likely to engage in selective reporting indicative of research waste than cellular trials. Improvements to place may help reduce these biases, whereas cellular trials may benefit from adopting more translatable data methods. However, these findings are based on two trials. Further risk of bias appraisals are needed to determine the number of trials required to make robust these findings.
Keywords: Research Waste, Selective Reporting, PACE, Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, Clinical Trials, Research Integrity, Evidence-Based Medicine, E-utilities