How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Interventional procedure overview of pharyngeal electrical stimulation for neurogenic dysphagia

    Closed for comments This consultation ended on at   Request commenting lead permission

    Validity and generalisability of the studies

    • The studies recruited people with various causes of dysphagia, including stroke, ventilator-related, TBI, MS, and ALS. The severity of dysphagia and the interval between onset of dysphagia/injury to treatment varied between the studies.

    • The treatment protocol for PES was similar between studies, though there were differences in the strength of current used. The undertreatment of patients in the Bath (2016) RCT may have contributed to the negative findings of this trial.

    • Two meta-analyses were included in the key evidence (several others are listed in the appendix). The studies included in the meta-analyses were exclusively RCTs, most of which enrolled fewer than 50 patients. The findings of the meta-analyses were contradictory and seemed to differ based on different inclusion criteria used to select studies. Notably, Dziewas (2018) was excluded from Speyer (2022) but included in Cheng (2021). The 'overall treatment effect' presented by Cheng (2021) was also a combination of different outcomes (decannulation, PAS and DSRS) making interpretation of the effect difficult.

    • In sham-controlled RCTs, as patients could feel the effects of treatment, or the absence of treatment with sham, some patients may have become prematurely unblinded to treatment allocation. Furthermore, in the Bath (2016) RCT, patients randomised to sham may have inadvertently been exposed to a therapeutic dose of PES when establishing threshold and tolerance stimulation levels.

    • Two pilot RCTs were included in the key evidence (Restivo, 2013 and Herrmann, 2022). These studies were not powered to demonstrate non‑inferiority/superiority and were included to show the use of PES in different patient populations. These are progressive diseases, and their findings may not extend to post-stroke, traumatic brain injury and other non-progressive disease populations.

    • Most studies did not conduct an adjustment for multiple comparisons during statistical analysis. Testing many hypotheses without adjustment for multiple comparisons increases the likelihood of a Type 1 error (false positive).

    • Studies were conducted in countries across Europe, including the UK.