The next questions were aimed at trying to understand how satisfied the patients were with using the CALEX to collect the samples and what the comparison was to collecting the sample in universal tubes instead. There were 13 ‘no responses’ received for the last question regarding the comparison between the historic universal tube and current CALEX collection method which was significantly higher than the other questions. The assumption here is that the historic universal tube had not previously been used. It can be seen from the responses that the vast majority of patients found the CALEX easier, or certainly no more difficult to use to collect their stool samples into, than the traditional universal tubes and they were confident that they had completed the process correctly. 25% of the patients who responded to the survey also filled in comments. Detailed feedback is invaluable as it lets us know what went well andwhat needs improving. In broad terms, these can be categorised as follows: • Missing instructions: Z Patients reported using Google or YouTube to find out how to use the devices, and I think this suggests that we need to look at our processes for how we get the CALEX and the instructions to the patients. Z Not clear on where to return the CALEX to, and again I think this may need to be clearer on our instructions - what the patient does with the sample once it is collected. • Sample collection concerns: Z Difficulty getting the white cap off – this could be an issue for older patients or those who may have dexterity issues. However, in the main calprotectin is more often a test used for younger patients. The older age group are more likely to receive faecal immunological testing (FIT) instead. Z Difficulty getting sample into the grooves with different sample consistencies. Although there were some issues highlighted, there was also quite a lot of positive feedback which was nice to see. Healthcare Professionals A second survey was sent to front line healthcare professionals who are issuing the CALEXdevices to thepatients andprovidingadviceon their use. In themain thiswould have been secondary care professionals, but there would have been an element of primary care too. We received 13 responses back indicating that generally the CALEX were given out frequently and that they thought the instructions were clear. Some of the additional feedback that came from the healthcare professionals was that advise was often sought from patients regarding whether the buffer needed to remain in the CALEX tube and there was confusion regarding the storage requirements for the CALEX. CALEX Preferred to Sample Collection via Universal Tube The majority of patients found the CALEX devices easy to use, with accessible instructions and overall the CALEXwere rated in preference to the standard universal tubes. The feedback shows that there could be improvements in some areas on the instructions regarding sample consistency challenges and the presence of the extraction buffer. Also, in the implementation to ensure instructions accompany each CALEX device, as they are currently provided to the front line staff separately. Changes have already been made to the IFU, to address the storage condition confusion that came up during the survey, as the CALEX can now be stored at ambient, so that eliminates the concern and makes it much easier to implement going forward. We actually used the generic IFU from the www.calprotectin.co.uk website so there is no specific information regarding the return of samples and in the main this has been fine for us, but it might be worth considering a customised version with detailed return requirements if it proves to be a problemmoving forward. In the main this has been a very reassuring exercise, confirming that what we are doing is very well accepted and seems to be working for the majority of patients. This was also demonstrated in the fact that the previous audit showed a 95% compliance rate and only 6% of returned samples couldn’t be analysed (incorrect liquid level, spoiled, not labelled) showing that patients were able to follow the instructions. It has certainly made our lives a lot easier in the labs and the patients are finding it easy to use, so giving the CALEX to the patients is certainly something that we plan to continue to do.” For more information please visit: www.calprotectin.co.uk/calex More confident that the device was used correctly. This was easier than the universal tube – it was straight forward and the instructions were clear as they also came with images to refer to. www.alphalabs.co.uk © 2023 Copyright Alpha Laboratories Ltd. 5
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