Three Good Dysphagia References

Eisenhuber, E., Schima, W., Schober, E., Pokieser, P., Stadler, A., Scharitzer, M., et al. (2002). Videofluoroscopic assessment of patients with dysphagia: pharyngeal retention is a predictive factor for aspiration. American Journal of Roentgenology, 178(2), 393-398.

Perlman, A. L., Booth, B. M., & Grayhack, J. P. (1994). Videofluoroscopic predictors of aspiration in patients with oropharyngeal dysphagia. Dysphagia, 9 (2), 90-95.

Rosenbek, J. C., Robbins, J. A., Roecker, E. B., Coyle, J. L., & Wood, J. L. (1996). A penetration-aspiration scale. Dysphagia, 11(2), 93-98.

Not Necessarily Turning A Dead Horse Into A Rug: More On Vital Stim

With all due respect, and at the risk of turning the dead horse into a rug, the meta-analysis published by Carnaby-Mann and Crary, used excessively lax inclusion criteria, rendering the results very difficult if not impossible to generalize to the clinical setting. Here is one set of examples to support this comment, and there are several others that the discussion group certainly does not want to hear.

A meta-analysis is only as good as the criteria for allowing studies to be included. They need to be rigorous.

The use of the Physiotherapy Evidence Database scale (PEDro) scale for judging evidence quality, at a cutoff score of 4 on the scale, allowed studies such as Freed, et al. (2001) (we all know which study that was and all of its problems-it is only one example from this meta-analysis’s included studies), to be included in the meta-analysis. Freed et al. (2001), as we all are aware, a) violated intention to treat with 10% of their patients disappearing from the data analysis for unexplained reasons or because they could not pay for the treatment after insurance terminated coverage(PEDro item 9), used judges that were not masked to patient assignment (PEDro item 6 and 7), selectively assigned patients to electrical stimulation “because they were referred for the study” (PEDro items 3 and 5), compared dissimilar groups of heterogeneous patients and excluded patients for unexplained reasons (PEDro item 4), and did not randomly assign patients to groups (PEDro item 2). In addition the study was conducted by the owner of the patent for the technology investigated, a serious conflict of interest not even acknowledged as an important criterion for evidence quality assessment by the PEDro. These serious flaws notwithstanding Carnaby-Mann and Crary included this, and several other studies of poor evidence quality, in their meta-analysis. The results must be considered weak and ungeneralizable to the clinical setting, at best, given the inclusion of poor quality studies.

Meta-analysis is an effort to use the best literature available to answer important questions about cause and effect. This study did not accomplish that goal. The lack of good quality studies does not justify the use of poor quality studies to make important decisions about treatment effectiveness or efficacy. It is always possible for a faction to cherry pick results from various studies to support their point of view. That is not what meta-analysis is about. This is why Vioxx was such a colossal failure.

James L. Coyle

University of Pittsburgh

Vital Stim Research: Questions and Answers

There were several interesting findings from Dr. Ludlow's study looking at the effect of applying NMES to the anterior portion of the neck, including the improvement in swallowing from sensory stim alone that Dr. Day mentioned. Another outcome that is often not mentioned is the unexpected finding that the patients who had greatest hyoid depression had the greatest improvement in swallowing. I would be interested to see future research looking into the cause behind this counter-intuitive finding. While these findings could possibly suggest a positive effect from using NMES during tx, as the authors point out, this is not a treatment study but an effect study. Therefore, conclusions should not be made, either positive or negative, about the impact these findings may have on treatment.

Instead, we should make conclusions about treatment based on treatment studies. One study worth noting is Carnaby-Mann GD, Crary MA. Examining the evidence on neuromuscular electrical stimulation for swallowing: a meta-analysis. Arch Otolaryngol Head Neck Surg. June 2007; 133 (6): 564-571.

With regards to the question "where is research on chronic dysphagia (1 year post)?"asked in an earlier posting , look for Dr. Carnaby-Mann and Dr. Crary's study "Adjunctive neuromuscular electrical stimulation for treatment refractory dysphagia: A phase I case series report" which will be published in the Annals of Otology, Rhinology & Laryngology soon. The patients in this study were an average of 5 years post onset.

With regards to any research, rather than focusing on the source of funding, I believe it is more productive to critically read the entire study, look at the research methodology, and then make decisions about if the the findings are applicable to what we do in treatment. Again, we should agree to disagree on what conclusions we will each make.

The debate about using NMES in swallowing tx has been good for our profession in that it has challenged us to look at the research behind what we do as clinicians. The caliber of research that we are requesting about VitalStim (randomized controls, studies that account for the possibility of spontaneous recovery) should be sought for all our therapies.

Jen Carter, M.Ed., CCC-SLP
Clinical Specialist, VitalStim Therapy