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Furthermore, given the absence of blinding in the study (except for the assessor) we cannot rule out performance bias.
Several overriding problems with trial design were evident: (i) small trial size, (ii) absence of blinding, (iii) lack of no treatment arms and (iv) highly variable entry criteria, treatments and endpoint definitions leading to trial clinical heterogeneity.
The commentary by Drs. Francis and Cole discusses the review by Drs. Rosen and Myerburg and details how trial outcomes can be affected by noise, poor trial design (particularly the absence of blinding), and normal human tendencies toward optimism and denial.
The absence of blinding of allocated intervention was the most frequent methodological component introducing a high risk of bias.
This absence of blinding did not seem to have had a significant influence on the results because the diagnosis of infection was determined during dressing changes on ward rounds using the outlined criteria.
Some limitations of this study should be taken into account including single center design, absence of blinding, exclusion of patients with suspected pneumonia at ICU admission, and absence of evaluation of microaspiration, colonization, or tracheal ischemia.
Similar(24)
Because of the absence of proper blinding, and the inconsistency of the findings, we conclude that further studies are required to evaluate whether or not a causal relationship exists between MSG ingestion and headache.
In the absence of successful blinding, biases may explain the results of a trial.
The main contributors of low scores were absence of double blinding, loss of participants to follow-up and poor description of cross-overs in the control group.
3 All six trials scored 3 out of 6 on the study quality scale because of the absence of double blinding and lack of information on concealment.
A still ongoing controversy is to know whether the absence of true blinding of cause of death assessors may have introduced bias in the results of these trials.
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