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"Research Waste in ME/CFS" (pre-print) by Sonia Lee

Dolphin

Senior Member
Messages
17,567
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
 

Dolphin

Senior Member
Messages
17,567
I wasn't that impressed with this.

PACE on the otherhand, recruited a large sample size for an early phase trial, with no evidence of pre-trial risk assessments on standard operating procedures and clinical trial protocols which normally recruit small sample sizes in early phase trials (so to limit risks on the population of interest).
There were earlier, smaller trials of CBT and GET

PACE did not specify who collected data, the types of software used, or whether the interventions were curative (given there were no treatment endpoints) and relevant to clinical practice.
Another PACE Trial paper reported on recovery.

It confirms the concerns 212 raised by ME/CFS groups that psychosocial interventions are harmful, and 213 present questionable therapeutic benefits no diffrent to a placebo (Childs et. 214 al., 2015; Lian & Nettleton, 2015).
I would love if this was true but I'm not sure the paper has really shown this.
 
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