Risk assessment for the NCPES-based recruitment method
| Potential risk | Action to limit or resolve risk | Risk rating |
|---|---|---|
| Inappropriate patients are identified by NHS Trusts | Trusts to be given a guidance manual with clear criteria for selecting patients. Based on the NCPES—holding codes are no longer used, so patients given an ICD-10 code will have cancer | Low |
| Young people who have died are contacted to participate | Quality Health under take DBS checks to remove deceased patients | Low |
| Patient identifiable data from NHS Trust that is being used without patient consent being transferred incorrectly | Data transfer using the methods that exist for the NCPES, which Trusts are familiar with | Low |
| Contact forms being sent to incorrect address | Only the addresses provided by the NHS Trust will be used | Low |
| Young persons do not know they have cancer | BRIGHTLIGHT and Quality Health have advice lines for young people to contact if they have any concerns about the study. Links would be made to the clinical team to provide appropriate support | Low |
| Contact forms do not get returned by post | Follow-up letters to be sent on two occasions | Medium |
| Recruiting Trusts stop recruiting using standard methods because the NCPES-based method is viewed as a replacement | Letter to be sent to principal investigators explaining why this method is being used in conjunction with existing routes to recruitment | Medium |
| Young people are approached twice about the study | Covering letter with the information pack to state that if they have already been contacted/consented to BRIGHTLIGHT to return the letter in the envelop provided so they do not receive reminder letters | Medium |
| Young people have been transferred to another Trust, so it is not possible to confirm eligibility | The BRIGHTLIGHT team have a network of contacts across recruiting Trusts so they would identify the Trust the young person has been transferred to and contact the team there. If the identifying Trust does not know the location of where the young person has been transferred to, this information will be sought from the North West Knowledge Intelligence Team under the existing Section 251 approval | Low |
| Young people have been transferred to a Trust that is not recruiting to BRIGHTLIGHT | The BRIGHTLIGHT team would contact the Principal Treatment Centre to determine whether they would be able to confirm eligibility (from their MDT information). If eligibility can be confirmed, the young person will be invited to participate as detailed in the protocol. If eligibility cannot be confirmed, the BRIGHTLIGHT team will contact young people to explain the error and will offer them a place in the YAP, the BRIGHTLIGHT user group | Low* |
| Patients are found to be not eligible after the contact form has been returned and checks made with the clinical team by the BRIGHTLIGHT team | The BRIGHTLIGHT team will contact the young person to explain the error. If young people have a cancer diagnosis, they will be offered a place in the YAP | Low |
| Consent forms are not returned to the BRIGHTLIGHT team after the young person has been interviewed | Ipsos MORI field interviewers will receive additional training and will return the consent form with their contact records when the interview is complete | Low |
| A high attrition rate by young people recruited by this method | There is a dropout rate between recruitment and data collection at the first wave of 25%. Potentially there may be a higher rate of dropout if information has not been given face-to-face. There is insufficient evidence to quantify this and therefore the BRIGHTLIGHT team and Ipsos MORI will monitor dropout (and subsequent attrition at waves 2–5) in this group separately from the rest of the cohort | Low† |
*If a Trust is not participating, then information required in the case report form may not be obtainable, so there will be the potential for missing data. This is anticipated as being low risk.
†Risk to data collection and not to young people.
DBS, Demographics Batch Service; NCPES, National Cancer Patient Experience Survey; YAP, Young Advisory Panel.