IQoro for hiatus hernia

Level of innovation

None of the specialists thought that IQoro had been superseded or replaced. All 3 thought that the device was a novel concept for treating hiatus hernia.

One specialist mentioned electrical stimulation devices, such as VitalStim and Ampcare, are available for treating oropharyngeal dysphagia but added that these are not marketed for the treatment of hiatus hernia. No other competing technologies were mentioned.

Potential patient impact

One specialist thought that reduced medication burden was a potential benefit of IQoro. A reduced risk of long-term proton pump inhibitor (PPI) use was also mentioned, with another commentator adding that IQoro could be more cost effective than PPI medication or surgery. A third agreed that the main benefits are the non-invasive and non-pharmacological nature of the device. One specialist added that consideration should also be given to lifestyle changes.

It was suggested that the device would be a particular advantage to elderly patients, because of the higher risk of surgery in this group. Motivated patients were also thought to be more likely to see benefit, along with patients on multiple medications. One expert thought that it was unclear which patient groups would particularly gain from using IQoro. Another thought that all people with dysmotility because of hiatus hernia would most benefit.

One specialist believed that IQoro had the potential to reduce prescription of medications and reduce the rate of surgery. Another thought that potential changes to the current pathway were unclear because of the limited evidence base. A third thought that the device has the potential to change the current pathway but agreed that more robust evidence was needed.

Potential system impact

One specialist believed that IQoro could lead to cost savings for the health and care system, costing less than standard care. Two specialists thought that more evidence was needed to assess IQoro's benefits to the health system, with 1 suggesting that powered, randomised trials with multidimensional evaluation were needed. The resource impact was considered to be a reduction in surgical procedures and outpatient appointments, leading to potential cost savings. Two specialists reiterated that more evidence was needed to show this economic benefit. One also thought that extra evidence could additionally inform patient selection and that regular interim evaluations would also be needed.

Two specialists did not think that any changes to infrastructure or specific training would be needed to use IQoro. One thought that there would need to be training for healthcare professionals. They added that clarity would be needed on the disease being treated to ensure that the most appropriate healthcare professional could be established. It was suggested that while a speech and language therapist may be the most appropriate for oropharyngeal dysphagia, this may not be the case for hiatus hernia. The resource of other healthcare professionals would also need to be taken into consideration.

Two specialists thought that there were no safety concerns around IQoro but 1 thought that this would need to be considered on a case-by-case basis.

General comments

Two specialists felt that the evidence base was limited. One felt that an inability to understand true adherence to exercise programmes could be a fault in the current evidence. They added that the effect of increased contact with healthcare professionals on patient-reported outcomes was not addressed.

One commentator was unsure if the technology would be an addition to or replacement of standard care. Another thought that it would be an addition and a third believed that it could be a prequel or an adjunct to current care. There were considered to be no practical issues with the usability of the device, other than in some patients who would need assistance in doing the training with IQoro.

One commentator was unaware of any issues preventing the adoption of IQoro. Two believed that the lack of evidence was the only issue preventing the adoption of IQoro in their organisation and in the wider NHS. One added that the absence of research done by research groups other than those including the inventor of the device was an obstacle.

One specialist felt that clarification was needed on whether patients recruited to the included studies continued to take PPIs during the training period, as instructed. It was thought to be important to understand if the device is more effective as a replacement or as an adjunct to PPI medication. Another specialist thought that a large randomised trial comparing IQoro to standard care was required. A third believed that an independent, suitably powered, randomised study with a sham treatment group or a no treatment group was necessary to assess IQoro's efficacy. They believed this would need to assess the device's effectiveness in pharyngeal stage dysphagia, oral stage dysphagia, oesophageal dysmotility and hiatus hernia. Further, they felt that outcomes should include clinician rated, patient-reported and instrumental outcome measures across the entire cohort.