Testing for thrombophilia: clinical update

Recommendations on the Use of Open Surgical and Endovascular Aneurysm Repair for the Management of Unruptured Abdominal Aortic Aneurysm from the Guideline Development Committee Appointed by the UK National Institute for Health and Care Excellence

Risk-Based Triage for Nephrology Referrals: The Time is Now

Venous thromboembolism prophylaxis: do trial results enable clinicians and patients to evaluate whether the benefits justify the risk? proceedings of an ad hoc working group meeting

IntroductionThe National Health Service (NHS) in England aims to be carbon neutral by 2045, acknowledging the link between planetary and human health. By 2028, NHS suppliers will need to report carbon footprint data for their products, including the medicines and technologies that the National Institute for Health and Care Excellence (NICE) appraises. Additionally, company level data are already being reported. This type of data may provide NICE with an opportunity to support system environmental sustainability goals.MethodsThe NICE Science Policy and Research team conducted an options appraisal to consider the feasibility and acceptability of different ways NICE might engage with environmental impact data (EID). We held discussions with NICE teams that could be affected by the collection and use of EID. Discussions examined the array of potential options for NICE—from being a simple conduit for EID to incorporating EID into its decision-making—and sought to identify those that were practical for further consideration. We then discussed these options with key external stakeholders (NHS England, industry, and commissioners) to understand their expected usefulness and practicality.ResultsSeveral options for NICE to use EID were identified as suitable for further consideration. Using company level data, NICE could encourage companies to engage with NHS sustainability goals by citing their carbon reduction plans alongside guidance or using them to prioritize its activities. Using product level data, NICE could pilot an evaluation comparing the environmental outcomes of competing health technologies that have no differential direct health outcomes. NICE could also publish environmental impact assessment tools to help commissioners consider EID in procurement decisions. Better data and methodological standards are needed before NICE might consider embedding product-level EID in its usual decision-making frameworks.ConclusionsOur options appraisal has identified several ways that NICE might start to engage with EID to have a positive impact on NHS sustainability goals and wider planetary health. Future work will scope out how these activities should proceed. The identified options are not necessarily mutually exclusive and may evolve as the data and methods around sustainable health care continue to advance.

How high should it be?

Natriuretic peptide (NP) testing is recommended for patients presenting to primary care with symptoms of chronic heart failure (HF) to prioritise referral for diagnosis. To report NP test performance at European Society of Cardiology (ESC) and National Institute for Health and Care Excellence (NICE) guideline referral thresholds. Diagnostic accuracy study using linked primary and secondary care data (2004 to 2018). The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of NP testing for HF diagnosis was assessed. In total, 229 580 patients had an NP test and 21 102 (9.2%) were diagnosed with HF within 6 months. The ESC NT-proBNP threshold ≥125 pg/mL had a sensitivity of 94.6% (95% confidence interval [CI] = 94.2 to 95.0) and specificity of 50.0% (95% CI = 49.7 to 50.3), compared with sensitivity of 81.7% (95% CI = 81.0 to 82.3) and specificity of 80.3% (95% CI = 80.0 to 80.5) for the NICE NT-proBNP ≥400 pg/mL threshold. PPVs for an NT-proBNP test were 16.4% (95% CI = 16.1 to 16.6) and 30.0% (95% CI = 29.6 to 30.5) for ESC and NICE thresholds, respectively. For both guidelines, nearly all patients with an NT-proBNP level below the threshold did not have HF (NPV: ESC 98.9%, 95% CI = 98.8 to 99.0 and NICE 97.7%, 95% CI = 97.6 to 97.8). At the higher NICE chronic HF guideline NP thresholds, one in five cases are initially missed in primary care but the lower ESC thresholds require more diagnostic assessments. NP is a reliable 'rule-out' test at both cut-points. The optimal NP threshold will depend on the priorities and capacity of the healthcare system.

Pain of lumbar facet-joint origin is a common cause of low back pain in adults and may lead to chronic pain and disability, with associated health and socioeconomic implications. The socioeconomic burden includes an inability to return to work resulting in loss of productivity in addition to direct and indirect health-care utilisation costs. Lumbar facet-joints are paired synovial joints between the superior and inferior articular processes of consecutive lumbar vertebrae and between the fifth lumbar vertebra and the sacrum. Facet-joint pain is defined as pain that arises from any structure that is part of the facet-joints, including the fibrous capsule, synovial membrane, hyaline cartilage and bone. This pain may be treated by intra-articular injections with local anaesthetic and steroid, although this treatment is not standardised. At present, there is no definitive research to support the use of targeted lumbar facet-joint injections to manage this pain. Because of the lack of high-quality, robust clinical evidence, the National Institute for Health and Care Excellence (NICE) guidelines on the management of chronic low back pain [NICE. Low Back Pain in Adults: Early Management. Clinical guideline (CG88). London: NICE; 2009] did not recommend the use of spinal injections despite their perceived potential to reduce pain intensity and improve rehabilitation, with NICE calling for further research to be undertaken. The updated guidelines [NICE. Low Back Pain and Sciatica in Over 16s: Assessment and Management. NICE guideline (NG59). London: NICE; 2016] again do not recommend the use of spinal injections. To assess the feasibility of carrying out a definitive study to evaluate the clinical effectiveness and cost-effectiveness of lumbar facet-joint injections compared with a sham procedure in patients with non-specific low back pain of > 3 months' duration. Blinded parallel two-arm pilot randomised controlled trial. Initially planned as a multicentre study involving three NHS trusts in the UK, recruitment took place in the pain and spinal orthopaedic clinics at Barts Health NHS Trust only. Adult patients referred by their GP to the specialist clinics with non-specific low back pain of at least 3 months' duration despite NICE-recommended best non-invasive care (education and one of a physical exercise programme, acupuncture or manual therapy). Patients who had already received lumbar facet-joint injections or who had had previous back surgery were excluded. Participants who had a positive result following a diagnostic test (single medial branch nerve blocks) were randomised and blinded to receive either intra-articular lumbar facet-joint injections with steroids (intervention group) or a sham procedure (control group). All participants were invited to attend a group-based combined physical and psychological (CPP) programme. In addition to the primary outcome of feasibility, questionnaires were used to assess a range of pain-related (including the Brief Pain Inventory and Short-Form McGill Pain Questionnaire version 2) and disability-related (including the EuroQol-5 Dimensions five-level version and Oswestry Low Back Pain Questionnaire) issues. Health-care utilisation and cost data were also assessed. The questionnaire visits took place at baseline and at 6 weeks, 3 months and 6 months post randomisation. The outcome assessors were blinded to the allocation groups. Of 628 participants screened for eligibility, nine were randomised to receive the study intervention (intervention group, n = 5; sham group, n = 4), six completed the CPP programme and eight completed the study. Failure to achieve our expected recruitment targets led to early closure of the study by the funder. Because of the small number of participants recruited to the study, we were unable to draw any conclusions about the clinical effectiveness or cost-effectiveness of intra-articular lumbar facet-joint injections in the management of non-specific low back pain. Although we did not achieve the target recruitment rate from the pain clinics, we demonstrated our ability to develop a robust study protocol and deliver the intended interventions safely to all nine randomised participants, thus addressing many of the feasibility objectives. Stronger collaborations with primary care may improve the recruitment of patients earlier in their pain trajectory who are suitable for inclusion in a future trial. EudraCT 2014-003187-20 and Current Controlled Trials ISRCTN12191542. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 74. See the NIHR Journals Library website for further project information.

Long COVID guidelines need to reflect lived experience

Emotion-based medicine or evidence-based medicine?

ContextThe National Institute for Health and Care Excellence (NICE) has an explicit mandate to include patient and public involvement in the appraisal of medicines to be available for funding on the NHS. NICE involves an appraisal committee who are required to take on board experiential evidence from patient experts alongside population‐based evidence on clinical and cost‐effectiveness when making a decision whether to fund a drug.ObjectiveThis paper considers how NICE Single Technological Appraisal (STA) committees attempt to incorporate the views of patients in making decisions about funding medicines on the NHS.MethodsA prospective design was employed to follow three pharmaceutical products involving three different appraisal committees. Three data collection methods were used: analysis of documentary evidence sent by NICE, non‐participant unstructured observations of the open and closed sessions of meetings and qualitative interviews.Settings and participantsUnstructured non‐participant observations were carried out at nine STA meetings, and 41 semi‐structured interviews were undertaken with committee members from NICE's STA committees, patient experts, analysts from NICE's project team and drug manufacturers.ResultsOur analysis showed how the committees displayed a preference for an ideal‐type of patient representative, disagreement among the committee when weighing‐up patient statements in the STA process and more pre‐preparation support for patient involvement.ConclusionsAlthough NICE has attempted to adopt an approach flexible to patients and carers through formal decision‐making arrangements that incorporate patient views, nonetheless, the processes of the STAs can in fact undermine the very evidence collected from patient representatives.

PNS262 EARLY DIALOGUE WITH NICE AND EUNETHTA: A UK PERSPECTIVE IN A POLITICALLY UNCERTAIN ERA

Coronary revascularisationSurgery is effective on clinical and economic grounds, but stenting does not seem to be cost effective This week, the BMJ publishes three studies dealing with revascularisation in ischaemic...

ObjectivesTo assess compliance with 2010 National Institute for Health and Care Excellence (NICE) guidance on cancer services relating to the management of basal cell carcinomas (BCC) in the community, where...

All healthcare systems operate with limited resources and therefore need to set priorities for allocating resources across a population. Trade-offs between maximising health and promoting health equity are inevitable in this process. In this paper, we use the UK’s National Institute for Health and Care Excellence (NICE) as an example to examine how efforts to promote healthcare innovation in the priority-setting process can complicate these trade-offs. Drawing on NICE guidance, health technology assessment reports and relevant policy documents, we analyse under what conditions NICE recommends the National Health Service fund technologies of an “innovative nature”, even when these technologies do not satisfy NICE’s cost-effectiveness criteria. Our findings fail to assuage pre-existing concerns that NICE’s approach to appraising innovative technologies curtails its goals to promote health and health equity. They also reveal a lack of transparency and accountability regarding NICE’s treatment of innovative technologies, as well as raising additional concerns about equity. We conclude that further research needs to evaluate how NICE can promote health and health equity alongside healthcare innovation and draw some general lessons for healthcare priority-setting bodies like NICE.

The UK's National Institute for Health and Care Excellence (NICE) recently launched a consultation on the methods it uses to evaluate new health technologies, and has highlighted the issue of how 'modifiers', including equity weights, should be incorporated into its processes. The practice of applying equity weights to specific population subgroups, as a means for increasing the effective cost-effectiveness threshold for some new health technologies, is well established in health technology assessment. It is also the subject of extensive discussion in the academic literature. In this paper, we demonstrate that NICE's current approach to equity weighting has the effect of reducing both population health and equity-weighted population health, a fundamental problem that appears to place NICE in contravention of its principles and obligations. We consider two potential methods for modifying NICE's current approach to address this problem. We also consider the merits of NICE abandoning its current approach to equity weighting and adopting a standard 'net benefit' approach in its place. We find that adopting a standard 'net benefit' approach is the most desirable option, as it provides for the most transparency while avoiding specific issues that arise when attempting to modify NICE's current approach. Regardless of the approach NICE uses for equity weighting, we find that protecting the health of National Health Service patients requires that some new technologies be evaluated using an effective cost-effectiveness threshold lower than the 'supply-side' cost-effectiveness threshold. This poses a particular challenge for NICE, given its obligations under the 2019 'Voluntary Scheme' between the UK pharmaceutical industry, the National Health Service, and the UK Government. We conclude by making some recommendations as to how NICE can move forward with the use of 'modifiers' in its decision making.