Involving patients in the health technology assessment (HTA) lifecycle is a core principle at the National Institute for Health and Care Excellence (NICE). To achieve this, NICE has adopted a mixed approach to patient and public involvement and engagement (PPIE) spanning the entire appraisal process. To ensure the PPIE approach enables meaningful involvement, NICE engaged with stakeholders to review its effectiveness and identify areas for improvement.

In 2023, an independent consultant reviewed NICE’s PPIE approach and engaged with NICE staff and external stakeholders from patient organizations, individual patient contributors, and engagement leads at national health and social care organizations. The engagement included interviews with NICE staff (n=19) and external stakeholders (n=13), and an online survey that received 83 responses from patient organizations and patient contributors. Using this feedback, NICE’s patient and public involvement program conducted four focus groups to develop a framework of improved methods and processes for PPIE with NICE staff, patient organizations, and patient contributors.

The engagement identified many positives in NICE’s approach to PPIE, including:

• • lay members sitting on each HTA committee as equal members

• • patient organizations providing written evidence to HTA committees

• • patient experts providing written and verbal testimony to HTA committees

• • support provided by NICE.

The engagement also identified areas where PPIE could have a greater impact, including:

• • improved methods for collecting patient evidence and insight

• • strengthening the role of lay members

• • collating and reusing previously collected patient evidence

• • taking a proportionate approach to involving small organizations

• • allocating staff resources to focus on impactful PPIE practices.

NICE has developed a draft framework for an improved approach to increase the impact of PPIE in HTA decision-making. In 2024, NICE will publicly consult with NICE staff and external stakeholders to review the framework, agree the strategic aims, and develop metrics for measuring success. Following this consultation, the findings and NICE’s updated approach to PPIE will be presented.

The National Institute for Health and Care Excellence (NICE) heard from small organizations how resource intensive and difficult it is for them participate in medicines health technology assessments (HTA) since the COVID-19 pandemic. To provide additional support for these organizations or to provide alternative patient input, NICE explored implementing surveys directly with patients to share with patient stakeholder organizations and NICE’s HTA medicines committees.

Patient organizations and colleagues at NICE were included in the background investigation. Informal interviews were conducted with the HTA bodies in Wales and health technology colleagues in NICE about their experience of this method of patient input.

Two approaches were piloted:

(i) Developing the online questionnaire using the Summary of Information for Patients.

(ii) Developing a jointly branded questionnaire collaboratively with the patient organization and implementing a data-sharing agreement to share the raw data.

The survey was distributed by the patient organization, analyzed by NICE, and shared with the patient organization to inform their submission to NICE.

The results of the background investigation showed that the option to include this additional method of input could provide valuable support for patient organizations and has the potential to increase the amount and quality of patient input to an HTA committee.

Both pilots were successful in:

• • Supporting patient organizations’ input into a medicines HTA

• • Reducing the resources required from patient organizations.

• The second pilot added more value due to:

• • Collaboration, relationship, and building trust

• • Joint development of the survey

• • Data sharing and potential to add to patient evidence about a disease and treatments.

Surveys conducted directly with patients can help patient organizations participate in medicines HTAs, but they are only one element of developing more innovative and sustainable patient involvement in the process. HTA bodies need to innovate and work collaboratively with patient stakeholders to produce a menu of options for involvement so that it can be tailored to stakeholders’ resources.

Observational studies consistently report associations between tobacco use, cannabis use and mental illness. However, the extent to which this association reflects an increased risk of new-onset mental illness is unclear and may be biased by unmeasured confounding.

A systematic review and meta-analysis (CRD42021243903). Electronic databases were searched until November 2022. Longitudinal studies in general population samples assessing tobacco and/or cannabis use and reporting the association (e.g. risk ratio [RR]) with incident anxiety, mood, or psychotic disorders were included. Estimates were combined using random-effects meta-analyses. Bias was explored using a modified Newcastle–Ottawa Scale, confounder matrix, E-values, and Doi plots.

Seventy-five studies were included. Tobacco use was associated with mood disorders (K = 43; RR: 1.39, 95% confidence interval [CI] 1.30–1.47), but not anxiety disorders (K = 7; RR: 1.21, 95% CI 0.87–1.68) and evidence for psychotic disorders was influenced by treatment of outliers (K = 4, RR: 3.45, 95% CI 2.63–4.53; K = 5, RR: 2.06, 95% CI 0.98–4.29). Cannabis use was associated with psychotic disorders (K = 4; RR: 3.19, 95% CI 2.07–4.90), but not mood (K = 7; RR: 1.31, 95% CI 0.92–1.86) or anxiety disorders (K = 7; RR: 1.10, 95% CI 0.99–1.22). Confounder matrices and E-values suggested potential overestimation of effects. Only 27% of studies were rated as high quality.

Both substances were associated with psychotic disorders and tobacco use was associated with mood disorders. There was no clear evidence of an association between cannabis use and mood or anxiety disorders. Limited high-quality studies underscore the need for future research using robust causal inference approaches (e.g. evidence triangulation).

Globally, human rights violations experienced by persons with psychosocial, intellectual or cognitive disabilities continue to be a concern. The World Health Organization's (WHO) QualityRights initiative presents practical remedies to address these abuses. This paper presents an overview of the implementation of the initiative in Ghana.

The main objective of the QualityRights initiative in Ghana was to train and change attitudes among a wide range of stakeholders to promote recovery and respect for human rights for people with psychosocial, intellectual and cognitive disabilities.

Reports of in-person and online training, minutes of meetings and correspondence among stakeholders of the QualityRights initiative in Ghana, including activities of international collaborators, were analysed to shed light on the implementation of the project in Ghana.

In-person and online e-training on mental health were conducted. At the time of writing, 40 443 people had registered for the training, 25 416 had started the training and 20 865 people had completed the training and obtained a certificate. The team conducted 27 in-person training sessions with 910 people. The successful implementation of the project is underpinned by a committed partnership among stakeholders, strong leadership from the coordinating agency, the acceptance of the initiative and the outcome. A few challenges, both in implementation and acceptance, are discussed.

The exposure of the WHO QualityRights initiative to a substantial number of key stakeholders involved in mental healthcare in Ghana is critical to reducing human rights abuses for people with psychosocial, intellectual and cognitive disabilities.

Patient involvement is a core principle of the National Institute for Health and Care Excellence (NICE) and we continually strive to improve patient involvement in health technology assessments (HTAs) of medicines. We iteratively surveyed and reviewed how patient involvement can be improved with patient organizations, patient experts, NICE HTA decision-making committees, and staff. We re-examined feedback that we collect on an ongoing basis, as well as one-off evaluations, to check how we can improve patient involvement.

Improvements ranged from support for and how we work with patient stakeholders to training the various stakeholders who take part in the HTA process to build up a comprehensive and evolving training package and stimulate a cycle of continually improving patient involvement.

We reviewed the outcomes and recommendations from the following larger projects:

• • Review of public involvement across NICE 2015;

• • Improving meaningful patient involvement in HTAs 2019;

• • Improving patient expert involvement in committee meetings 2019; and

• • The value of patient expert input 2022.

Feedback from monthly surveys of patient experts and organizations was also reviewed.

The results included recommendations about:

• • Changing the culture so that patient involvement at NICE is everybody’s business;

• • The key role of the committee chair in including patient experts;

• • The importance of committee culture and behavior in including and valuing patient input;

• • The need for a greater understanding of how NICE technical teams can best support and obtain the most meaningful evidence from patients; and

• • What additional support and training patient organizations and experts want from NICE’s public involvement team.

We concluded that not only patients need training, but also everybody included in the NICE medicines HTA process. Over time we have gradually added to our training portfolio for patient organizations and experts as well as NICE staff and independent committees. We now run patient involvement as part of the induction program for all staff, technical staff, medicines committee chairs, and NICE committees and lay members.

We also provide monthly training for patient organizations and patient experts.

Attentional impairments are common in dementia with Lewy bodies and its prodromal stage of mild cognitive impairment (MCI) with Lewy bodies (MCI-LB). People with MCI may be capable of compensating for subtle attentional deficits in most circumstances, and so these may present as occasional lapses of attention. We aimed to assess the utility of a continuous performance task (CPT), which requires sustained attention for several minutes, for measuring attentional performance in MCI-LB in comparison to Alzheimer’s disease (MCI-AD), and any performance deficits which emerged with sustained effort.

We included longitudinal data on a CPT sustained attention task for 89 participants with MCI-LB or MCI-AD and 31 healthy controls, estimating ex-Gaussian response time parameters, omission and commission errors. Performance trajectories were estimated both cross-sectionally (intra-task progress from start to end) and longitudinally (change in performance over years).

While response times in successful trials were broadly similar, with slight slowing associated with clinical parkinsonism, those with MCI-LB made considerably more errors. Omission errors were more common throughout the task in MCI-LB than MCI-AD (OR 2.3, 95% CI: 1.1–4.7), while commission errors became more common after several minutes of sustained attention. Within MCI-LB, omission errors were more common in those with clinical parkinsonism (OR 1.9, 95% CI: 1.3–2.9) or cognitive fluctuations (OR 4.3, 95% CI: 2.2–8.8).

Sustained attention deficits in MCI-LB may emerge in the form of attentional lapses leading to omissions, and a breakdown in inhibitory control leading to commission errors.

To characterize opportunities to postprescriptively modify antibiotic prescriptions initiated for treatment of suspected urinary tract infection (UTI) in nursing homes.

Cross-sectional cohort study.

Data from the health records of residents treated for UTI between 2013 and 2014 in 5 Wisconsin nursing homes were abstracted using a structured approach. Explicit definitions were used to identify whether the prescribed antibiotic could have been stopped, shortened, or changed to a nonfluoroquinolone alternative. Antibiotic treatments appropriately modified by study nursing home providers in real time were not considered modifiable. Identification of >1 potential modification opportunity (eg, stop and shorten) per antibiotic treatment event was permitted.

In total, 356 eligible antibiotic treatment courses among 249 unique residents were identified. Only 59 antibiotic courses prescribed for treatment of suspected UTI (16.6%) were not amenable to any modification. Discontinuation of treatment due to lack of signs or symptoms of infection was the most frequently identified potential modification opportunity (66.2%). Although less common, substantial numbers of antibiotic treatment courses were potentially amenable to shortening (34%) or agent change (19%) modifications. If applied in concert at 72 hours after antibiotic initiation, stop and shorten modifications could eradicate up to 1,326 avoidable antibiotic days, and change modifications could remove a 32 remaining avoidable fluoroquinolone days.

Substantial opportunity exists to enhance the quality of antibiotic prescribing for treatment of suspected UTI in nursing homes through postprescriptive review interventions. Additional studies examining how to best design and implement postprescriptive review interventions in nursing homes are needed.

Impaired olfaction may be a biomarker for early Lewy body disease, but its value in mild cognitive impairment with Lewy bodies (MCI-LB) is unknown. We compared olfaction in MCI-LB with MCI due to Alzheimer’s disease (MCI-AD) and healthy older adults. We hypothesized that olfactory function would be worse in probable MCI-LB than in both MCI-AD and healthy comparison subjects (HC).

Cross-sectional study assessing olfaction using Sniffin’ Sticks 16 (SS-16) in MCI-LB, MCI-AD, and HC with longitudinal follow-up. Differences were adjusted for age, and receiver operating characteristic (ROC) curves were used for discriminating MCI-LB from MCI-AD and HC.

Participants were recruited from Memory Services in the North East of England.

Thirty-eight probable MCI-LB, 33 MCI-AD, 19 possible MCI-LB, and 32HC.

Olfaction was assessed using SS-16 and a questionnaire.

Participants with probable MCI-LB had worse olfaction than both MCI-AD (age-adjusted mean difference (B) = 2.05, 95% CI: 0.62–3.49, p = 0.005) and HC (B = 3.96, 95% CI: 2.51–5.40, p < 0.001). The previously identified cutoff score for the SS-16 of ≤ 10 had 84% sensitivity for probable MCI-LB (95% CI: 69–94%), but 30% specificity versus MCI-AD. ROC analysis found a lower cutoff of ≤ 7 was better (63% sensitivity for MCI-LB, with 73% specificity vs MCI-AD and 97% vs HC). Asking about olfactory impairments was not useful in identifying them.

MCI-LB had worse olfaction than MCI-AD and normal aging. A lower cutoff score of ≤ 7 is required when using SS-16 in such patients. Olfactory testing may have value in identifying early LB disease in memory services.

Measuring the appropriateness of antibiotic prescribing in nursing homes remains a challenge. The revised McGeer criteria, which are widely used to conduct infection surveillance in nursing homes, were not designed to assess antibiotic appropriateness. The Loeb criteria were explicitly designed for this purpose but are infrequently used outside investigational studies. The extent to which the revised McGeer and Loeb criteria overlap and can be used interchangeably for tracking antibiotic appropriateness in nursing homes remains insufficiently studied.

We conducted a cross-sectional chart review study in 5 Wisconsin nursing homes and applied the revised McGeer and Loeb criteria to all nursing home–initiated antibiotic treatment courses. Kappa (κ) statistics were employed to assess level of agreement overall and by treatment indications.

Overall, 734 eligible antibiotic courses were initiated in participating nursing homes during the study period. Of 734 antibiotic courses, 372 (51%) satisfied the Loeb criteria, while only 211 (29%) of 734 satisfied the revised McGeer criteria. Only 169 (23%) of 734 antibiotic courses satisfied both criteria, and the overall level of agreement between them was fair (κ = 0.35). When stratified by infection type, levels of agreement between the revised McGeer and Loeb criteria were moderate for urinary tract infections (κ = 0.45), fair for skin and soft-tissue infections (0.36), and slight for respiratory tract infections (0.17).

Agreement between the revised McGeer and Loeb criteria is limited, and nursing homes should employ the revised McGeer and Loeb criteria for their intended purposes. Studies to establish the best method for ongoing monitoring of antibiotic appropriateness in nursing homes are needed.

To develop an international template to support patient submissions in Health Technology Assessments (HTAs). This was to be based on the experience and feedback from the implementation and use of the Scottish Medicines Consortium's (SMC) Summary Information for Patient Groups (SIP).

To gather feedback on the SMC experience, web-based surveys were conducted with pharmaceutical companies and patient groups familiar with the SMC SIP. Semistructured interviews with representatives from HTA bodies were undertaken, along with patient group discussions with those less familiar with the SIP, to explore issues around the approach. These qualitative data informed the development of an international SIP template.

Survey data indicated that 82 percent (18 of 22 respondents) of pharmaceutical company representatives felt that the SIP was worthwhile; 88 percent (15/17) of patient group respondents found the SIP helpful. Both groups highlighted the need for additional support and guidance around plain language summaries. Further suggestions included provision of a glossary of terms and cost-effectiveness information. Patient group interviews supported the survey findings and led to the development of a new template. HTA bodies raised potential challenges around buy-in, timing, and bias connected to the SIP approach.

The international SIP template is another approach to support deliberative processes in HTA. Although challenges remain around writing summaries for lay audiences, along with feasibility considerations for HTA bodies, the SIP approach should support more meaningful patient involvement in HTAs.

Dopaminergic imaging is an established biomarker for dementia with Lewy bodies, but its diagnostic accuracy at the mild cognitive impairment (MCI) stage remains uncertain.

To provide robust prospective evidence of the diagnostic accuracy of dopaminergic imaging at the MCI stage to either support or refute its inclusion as a biomarker for the diagnosis of MCI with Lewy bodies.

We conducted a prospective diagnostic accuracy study of baseline dopaminergic imaging with [123I]N-ω-fluoropropyl-2β-carbomethoxy-3β-(4-iodophenyl)nortropane single-photon emission computerised tomography (123I-FP-CIT SPECT) in 144 patients with MCI. Images were rated as normal or abnormal by a panel of experts with access to striatal binding ratio results. Follow-up consensus diagnosis based on the presence of core features of Lewy body disease was used as the reference standard.

At latest assessment (mean 2 years) 61 patients had probable MCI with Lewy bodies, 26 possible MCI with Lewy bodies and 57 MCI due to Alzheimer's disease. The sensitivity of baseline FP-CIT visual rating for probable MCI with Lewy bodies was 66% (95% CI 52–77%), specificity 88% (76–95%) and accuracy 76% (68–84%), with positive likelihood ratio 5.3.

It is over five times as likely for an abnormal scan to be found in probable MCI with Lewy bodies than MCI due to Alzheimer's disease. Dopaminergic imaging appears to be useful at the MCI stage in cases where Lewy body disease is suspected clinically.