Specialist commentator comments
Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.
Two out of 4 specialist commentators were familiar with this technology but none had used it before.
Two specialists stated that this was a minor variation on existing technology. A third specialist said that the technology was novel, particularly because of its use as an initial assessment tool to complement FRAX and reduce dependence on dual‑energy X‑ray absorptiometry (DXA) imaging.
All 4 commentators agreed that users of Bindex would need some training, and 1 noted that if the device is used in a community setting (such as primary care centres and care homes), then a wide variety of allied health professionals would need training.
One specialist did not think the technology would benefit patients, in terms of treatment, patient experience or outcomes. Three specialists thought that Bindex may be useful for people who would have difficulties attending a hospital appointment for a DXA scan, such as people who are older, frail or have cognitive impairment. One specialist thought that Bindex would be useful for patients with intermediate FRAX risk.
One commentator noted that the available studies on Bindex only involved women of white European family origin, and that this meant that this group of patients were likely to benefit most from this technology because its potential benefits had not been studied in other groups. Two specialist commentators stated that there is currently no prospective evidence showing Bindex can predict fracture risk, and that this evidence is essential for an investigative tool assessing osteoporosis because treatments are mainly aimed at reducing fracture risk.
Another specialist stated that Bindex would provide better patient experience in comparison with DXA, as well as reduced radiation exposure. However, 2 commentators noted that DXA imaging has very low radiation compared with other X‑ray imaging and does not represent a significant risk.
One specialist stated that Bindex would be most useful in a community bone health clinic setting, whereas another stated that it could be used by nurse specialists in primary or secondary care alongside FRAX as part of fracture liaison services. Using Bindex in a fracture liaison service could contribute to the reduction of future fractures.
The specialists did not believe any change in NHS infrastructure or facilities would be necessary for Bindex to be adopted in the NHS, but 1 commentator stated that this would depend on the services in the local area (for example, some areas manage bone health in a community setting).
One specialist did not think that the use of Bindex would result in cost savings for the NHS. Three of the specialist commentators agreed that using Bindex could result in fewer hospital visits for DXA scans, which are more expensive than Bindex and this could lead to cost savings. One specialist felt that savings are also likely to occur through reduced patient transport services (for example, elective ambulance journeys) attending these appointments. Reducing the demand for DXA scans could also reduce waiting lists in some centres with higher throughput.
One specialist stated that any costs saved by reducing the number of DXA scans would be countered by the cost of additional pre-screening using Bindex. They also said that the cost of treating hip fractures that might be missed by Bindex because of false negatives. They felt that its predictive value for hip bone mass density is only moderately good. Another commentator stated that the licensing options are restrictive, because a 'pay as you go' scheme would encourage adoption and pilot testing of the technology with less financial risk.
One of the specialists stated that bone mass density measurements can vary between different anatomical sites, and there is not enough evidence to say whether the Bindex measurement at the tibia is comparable in predicting fracture risk to measurements at the hip or spine. This specialist also stated that more information on the concordance of Bindex with DXA and FRAX would be useful, particularly in understanding how BMD changes when it is measured with Bindex in comparison with DXA. More prospective studies on predicting fracture risk at non-spine and non-hip sites are needed, according to the specialist.
A second specialist commentator stated that anyone needing treatment should still have DXA imaging, even if Bindex is used. A third opinion was that including Bindex as a pre-screening tool would produce a less effective pathway overall. People who are found to be at high risk after an ultrasound but low risk after a DXA scan may raise anxiety and uncertainties about whether they need treatment. This specialist stated that there has extensive pathway redesign in recent years including significant increased capacity for DXA scans, and that the proposal to use Bindex would undermine existing NHS care pathways as well as having a negative effect on clinical and cost effectiveness.