National Institute for Health and Care Excellence
HSIB recommends that the National Institute for Health and Care Excellence reviews its current safety netting advice to healthcare professionals with respect to the investigation of possible lung cancer. The wording of the advice should be amended as required to make it clearer what should be offered to patients with ongoing, unexplained symptoms who have had a negative chest X-ray.
Following consideration of the Healthcare Safety Investigation Branch’s report, the National Institute for Health and Care Excellence (NICE) will update its guideline on suspected cancer: recognition and referral [NG12]. The update will review the current safety netting advice, which highlights the possibility of false-negative results for chest X-rays, and the diagnostic pathway for people with ongoing, unexplained symptoms who have had a negative chest X-ray.
Action: Commission an update of NG12. The update will be commissioned and scheduled into the guidelines work programme considering NICE’s existing workload and agreed priorities.
Action: Update NG12, to include a review of the current safety netting advice given in recommendation 1.15.1 and the diagnostic pathway for people with ongoing, unexplained symptoms who have had a negative chest X-ray. In line with NICE’s established processes, a number of people are involved in the development of clinical guidelines (see section 1.5 of developing NICE guidelines: the manual [PMG20]). The update will follow NICE’s established processes and methods S405for updating guidelines (see chapter 14 of developing NICE guidelines: the manual [PMG20]).
Response received on 10 January 2022.
NHSX
HSIB recommends that NHSX, in collaboration with relevant stakeholders such as The Royal College of Radiologists and The Society and College of Radiographers, develops guidance to support independent benchmarking and validation of artificial intelligence algorithms for the identification of lung diseases such as cancer.
We are happy to lead on one of HSIBs recommendations. To do this, it would take approximately 6-9 months to deliver by standing this up as a work programme, with a nominated lead. We would therefore require £50,000 (approximately) to cover the costs for resourcing, etc. As next steps, we will reach out to The Royal College of Radiologists and The Society and College of Radiographers, to understand who is leading on this request at their end and suggest a collective response to HSIB.
Response received on 25 January 2022.
National Institute for Health and Care Research
HSIB recommends that the National Institute for Health Research assess the priority, feasibility and impact of future research to address whether low-dose computed tomography (CT) is clinically and cost-effective for the diagnosis of lung cancer in symptomatic patients seen in primary care and consider the most appropriate way of building up the evidence base on this topic.
The National Institute for Health and Care Research (NIHR) funds health and social care research that improves people’s health and wellbeing. Working with those who use, plan and deliver health services in the UK, we identify and prioritise important topics to fund through specific calls for research.
The HSIB safety recommendation ‘Missed detection of lung cancer on chest X-rays of patients being seen in primary care’ was considered through the NIHR’s established commissioned workstream. After an initial ‘in house’ assessment of the topic to determine what is already known (review of the existing evidence base), the topic was further developed in collaboration with external experts (including NHS England and Innovation; specialists in chest medicine, GPs, radiologists, and research experts) to specify the parameters for the research including the patient population and outcome measures. This co-production approach, involving both those who use and those who generate the evidence, ensures that any research commissioned will provide the evidence needed by decision makers.
This highly specified research question was then considered by the NIHR’s relevant programme specific Prioritisation Committee (comprised of academics, clinicians and patients), who review and advise on the development of NIHR research topics. Following an initial recommendation by the Prioritisation Committee it was subsequently considered by specific methodological expertise to confirm the feasibility of the proposed research.
Taking account of the advice from the experts, members of the NIHR Programme Oversight Committee agreed that the research should take a phased approach initially focusing on commissioning a feasibility study to examine the use of low-dose chest CT in primary care and address important issues such as: CT and other NHS capacities; acceptability to patients and clinicians; potential harms, e.g. over-diagnosing harmless conditions. Importantly, this approach would also permit findings from the Targeted Lung Health Check programme to be taken account of and inform any future clinical trial to investigate the performance and cost-effectiveness of low-dose chest CT compared to chest X-ray in primary care.
In June 2022, the NIHR approved this research question for future advertisement.
Actions planned to deliver safety recommendation:
- Development of NIHR research question (call specification), including review of existing evidence. By January/February 2022.
- Draft call specification sent out for external peer review, including patients and the public. By April 2022.
- Call specification revised in light of peer review comments. By April 2022.
- Draft call specification considered by the relevant NIHR prioritisation committee. By March 2022.
- Following recommendation by the relevant NIHR Prioritisation Committee, consideration by the NIHR methodology group. By May 2022.
- Call specification considered for future advertisement by the relevant Programmes Oversight Committee. By June 2022.
- Call approved for future advertisement. By June 2022.
Resources in place: NIHR commissioned workstream.
Response received on 23 June 2022.