Un vínculo claro entre la evaluación y la toma de decisión constituye un principio de buena práctica en evaluación de tecnologías sanitarias (ETESA) reconocido a nivel internacional. El objetivo del Foro de Políticas en Latino-América (LatamPF) 2019 de Health Technology Assessment International fue explorar los diferentes modelos que vinculan la ETESA y la toma de decisión y discutir su potencial aplicabilidad en Latino-América.

Este manuscrito está basado en un documento base y en el trabajo deliberativo realizado por los miembros (54 participantes, 12 países) que asistieron al LatamPF, a través de la metodología design thinking.

Los participantes coincidieron en que la relación inapropiada entre la ETESA y la toma de decisión atenta hoy contra la legitimidad de las decisiones, expone al proceso de ETESA a una excesiva influencia política y judicial, y condiciona que algunos actores se sientan relegados del proceso de evaluación y toma de decisión. Se identificaron los atributos del proceso de ETESA más prioritarios y factibles de ser mejorados en la región, y con el mayor potencial para generar un cambio positivo en los sistemas de salud. La mayor parte de estos están vinculados con la apropiada institucionalización de la ETESA, ampliar la participación de los diferentes actores y mejorar la transparencia de los procesos de ETESA.

El LatamPF ha identificado barreras y recomendado acciones para reforzar el vínculo entre ETESA y la decisión. A su vez, existe en estos momentos una ventana de oportunidad en la región, ya que el tema es visualizado como una prioridad por gran parte de los actores de la sociedad. Por ello, los diferentes actores de los sistemas sanitarios deberían ahora tomar esta oportunidad para avanzar en el fortalecimiento del vínculo entre ETESA y toma de decisión.

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality in China. However, early identification of patients with COPD in the community is challenging. This study used a real-world survey of the Chinese urban adult population to estimate the prevalence of COPD diagnosis or COPD-risk, examine the health outcomes and healthcare resource use of these groups, and investigate the sociodemographic factors associated with these statuses.

Respondents to the 2017 National Health and Wellness Survey in China (n = 19,994) were classified into: COPD (diagnosed), COPD-risk (undiagnosed), and control (undiagnosed, not at-risk) using their self-reported diagnosis and Lung Function Questionnaire (LFQ) score. These groups were compared by healthcare resource use and health outcomes (EuroQol [EQ-5D] and Work Productivity and Activity Impairment questionnaires). Factors associated with being in these groups were investigated using pairwise comparisons (t-tests and chi-square tests) and multivariable logistic regression.

In total, 3,320 respondents (16.6%) had a suspected risk of COPD but did not report receiving a diagnosis. This was projected to 105.3 million people (16.9% of urban adults). Relative to the controls, COPD-risk and COPD-diagnosed respondents had higher healthcare resource use, lower productivity, and lower health-related quality of life (HRQoL) (p < 0.05). Age, smoking, alcohol consumption, weight, exercise, comorbidities, gender, education, employment, and air pollution were associated with increased odds of COPD-risk relative to the controls (p < 0.05).

A substantial group of individuals, undiagnosed, but with a risk of COPD, have impaired HRQoL, lower productivity, and elevated healthcare resource use. A range of sociodemographic factors are predictive of COPD risk, which may support targeted screening. Case-detection tools such as the LFQ may offer a convenient approach for identifying individuals for further definitive testing and appropriate treatment in China.

Precision medicines rely on companion diagnostics to identify patient subgroups eligible for receiving the pharmaceutical product. Until recently, the Belgian public health payer, RIZIV-INAMI, assessed precision medicines and companion diagnostics separately for reimbursement decisions. As both components are considered co-dependent technologies, their assessment should be conducted jointly from a health technology assessment (HTA) perspective. As of July 2019, a novel procedure was implemented accommodating for this joint assessment practice. The aim of this research was to formulate recommendations to improve the assessment in the novel procedure.

This study evaluated the precision medicine assessment reports of RIZIV-INAMI of the last 5 years under the former assessment procedure. The HTA framework for co-dependent technologies developed by Merlin et al. for the Australian healthcare system was used as a reference standard in this evaluation. Criteria were scored as either present or not present.

Thirteen assessment reports were evaluated. Varying scores between reports were obtained for the domain establishing the co-dependent relationship between diagnostic and pharmaceutical. Domains evaluating the clinical utility of the biomarker and the cost-effectiveness performed poorly, whereas the budget impact and the transfer of trial data to the local setting performed well.

Based on these results we recommend three amendments for the novel procedure. (i) The implementation of the linked evidence approach when direct evidence of clinical utility is not present, (ii) incorporation of a bias assessment tool, and (iii) further specify guidelines for submission and assessment to decrease the variability of reported evidence between assessment reports.

Synthesis of continuous and time-to-event outcomes is often complicated by the use of multiple outcome scales and heterogeneous reporting of outcomes across trials. Simple methods of evidence synthesis for clinical effectiveness can fail to account for these issues and result in a reduction of the evidence base, which can be further reduced at the cost-effectiveness stage as common outcome measures, such as standardized mean differences, cannot easily be incorporated into the economic decision model. Recent methodological advances for synthesizing continuous and time-to-event outcomes aim to include a greater proportion of the available evidence base within a single coherent analysis.

To assess the statistical methods commonly used in health technology assessment (HTA) and establish whether recent advances in synthesis methods have been adopted in practice, we conducted a review of HTA reports and guidelines published in the United Kingdom (UK) between 1 April 2018 and 31 March 2019 reporting a quantitative meta-analysis (MA), network meta-analysis (NMA) or indirect treatment comparison (ITC) of at least one continuous or time-to-event outcome.

Forty-seven articles were considered eligible for this review. Fifty-one percent of eligible articles reported at least one continuous outcome and 55 percent at least one time-to-event outcome. Twenty-nine articles reported NMA or ITC and twenty-seven reported MA of a continuous or time-to-event outcome. Forty articles included a decision model, of which twenty-seven incorporated evidence from a synthesis of a continuous or time-to-event outcome with eleven informed by a single trial (despite synthesis being conducted).

Uptake of methods to include a greater proportion of the available evidence base within a single coherent analysis in UK HTA reports has been slow. Evaluating health technologies using an evidence-based approach often results in better outcomes for patients. Therefore, HTA analysts and decision modelers must be aware of the expanding literature for synthesis of continuous and time-to-event outcomes and appreciate the limitations of simpler approaches.

Mental health disorders and their treatments produce significant costs and benefits in both healthcare and non-healthcare sectors. The latter are often referred to as intersectoral costs and benefits (ICBs). Little is known about healthcare-related ICBs in the criminal justice sector and how to include these in health economics research.

The triple aim of this study is (i) to identify healthcare-related ICBs in the criminal justice sector, (ii) to validate the list of healthcare-related ICBs in the criminal justice sector on a European level by sector-specific experts, and (iii) to classify the identified ICBs.

A scientific literature search in PubMed and an additional grey literature search, carried out in six European countries, were used to retrieve ICBs. In order to validate the international applicability of the ICBs, a survey was conducted with an international group of experts from the criminal justice sector. The list of criminal justice ICBs was categorized according to the PECUNIA conceptual framework.

The full-text analysis of forty-five peer-reviewed journal articles and eleven grey literature sources resulted in a draft list of items. Input from the expert survey resulted in a final list of fourteen unique criminal justice ICBs, categorized according to the care atom.

This study laid further foundations for the inclusion of important societal costs of mental health-related interventions within the criminal justice sector. More research is needed to facilitate the further and increased inclusion of ICBs in health economics research.

After the introduction of the seven-valent pneumococcal conjugate vaccine (PCV7) in the United States (US) in the year 2000, the incidence of invasive pneumococcal disease (IPD) caused by the seven vaccine serotypes declined by 80 percent in vaccinated children and 30 percent in unvaccinated adults. A transmission dynamic equation model developed in 2009 captured the direct and indirect effects of vaccination in the early years after vaccination. Subsequently, the vaccine program switched to the 13-valent PCV and adult PCV13 vaccination. This work explores the accuracy of the mathematical model to predict long-term IPD due to changes in US immunization practices.

The model simulates the acquisition of asymptomatic carriage of pneumococci and the development of IPD among individuals aged <2, 2–4, 5–17, 18–49, 50–64, and ≥65 years. Pneumococcal serotypes were stratified into three categories: PCV7-type (4, 6B, 9V, 14, 18C, 19F, and 23F), PCV6-type (1, 3, 5, 6A, 7F, and 19A), and non-PCV-type (all others). Model parameters were calibrated using US IPD surveillance data from 1998–2006. Model results were compared to observed epidemiology.

The model was previously shown to predict observed IPD well through 2007. After adjusting model parameters for PCV13 efficacy and adult vaccine coverage, modeled IPD closely replicated observed IPD. Observed baseline pre-vaccine incidence for children <2 years of age was 192 cases/100,000 and 13.5 cases in 2016, versus 18.5 cases estimated by the model. Similarly, observed versus modeled cases in the ≥65-year-old age group were 24 and 23.6 cases.

This epidemiologic model accurately simulates the observed US IPD surveillance data 17 years after initial introduction of PCV, highlighting the direct and indirect benefits of vaccination. Well-constructed mathematical models can accurately replicate real-world scenarios. Key input parameters of these models can then be modified to predict the impact of alternate scenarios, providing insights to inform public health policy-making.

To investigate the impact of the uncertainty stemming from products with European conditional marketing authorization (CMA) or authorization in exceptional circumstances (AEC) on the National Institute for Health and Care Excellence's (NICE) recommendations.

Products which received CMA/AEC by European Medicines Agency (EMA) up to 1 December 2016 were identified and matched with corresponding NICE decisions issued by August 2017, the status of which was then traced to August 2019. We assessed whether the conversion of CMA to full marketing authorization triggered a review of a NICE decision. The odds of a recommendation carrying a commercial arrangement for products with and without CMA/AEC were calculated.

Fifty-four products were granted CMA/AEC by EMA. NICE conducted thirty evaluations of products with CMA/AEC. Twelve products were recommended by NICE by August 2017 and fourteen by August 2019. All recommendations had an associated commercial arrangement. The odds of carrying a commercial arrangement were higher for products with CMA/AEC compared to those with full authorization. Conversions from conditional to full authorization among products not recommended by NICE did not trigger an appraisal review.

Uncertainty, stemming from the lack of robust clinical data of products authorized with CMA/AEC, has a substantial impact on HTA recommendations, frequently requiring risk mitigation mechanisms such as commercial and data collection arrangements. Further analyses should be conducted to assess whether the benefits of early access strategies outweigh the risks for patients and the healthcare system.

To describe the implementation of multi-criteria decision analysis (MCDA) into a Canadian public drug reimbursement decision-making process, identifying the aspects of the MCDA approach, and the context that promoted uptake.

Narrative summary of case study describing the how, when, and why of implementing MCDA.

Faced with a fixed budget, a pipeline of expensive but potentially valuable drugs, and potential delays to drug decision making, the Ministry of Health (i.e., decision makers) and its independent expert advisory committee (IAB) sought alternative values-based decision processes. MCDA was considered highly compatible with current processes, but the ability as a stand-alone intervention to address issues of opportunity cost was unclear. The IAB nevertheless collaboratively voted to implement an externally developed MCDA with support from decision makers. After several months of engagement and piloting, implementation was rapid and leveraged strong pre-existing formal and informal communication networks. The IAB as a whole rates new submissions which serves as an input into the deliberative process.

MCDA can be a highly adaptable approach that can be implemented into a functioning drug reimbursement setting when facilitated by (i) a truly limited budget; (ii) a shared vision for change by end-users and decision makers; (iii) using pre-existing deliberative processes; and (iv) viewing the approach as a decision framework rather than the decision (when appropriate). Given the current limitations of MCDA, implementing an academically imperfect tool first and evaluating later reflects a practical solution to real-time fiscal constraints and impending delays to drug approvals that may be faced by decision makers.

Secondary hyperparathyroidism (SHPT) is a consequence of non-dialysis chronic kidney disease (ND-CKD), causing disturbances in metabolic parameters including increased phosphate and parathyroid hormone (PTH) and reduced calcium serum level, which can cause bone disease, extra-skeletal calcification and increased cardiac disease risk through vascular and visceral calcification. According to Kidney Disease Improving Global Outcomes (KDIGO) guidelines in 2017, treatment with paricalcitol is no longer recommended in early stage CKD due to increased risk of hypercalcemia. Prolonged release calcifediol (PRC) has been developed as a novel treatment for SHPT in ND-CKD. The objective of this study was to compare the efficacy and safety of PRC versus paricalcitol by assessing biomarkers such as PTH, calcium and phosphate.

To identify relevant randomized control trials (RCTs) to be included in the network meta-analysis (NMA), a systematic literature search was performed in PubMed. All analyses were performed with a frequentist random-effects NMA. Comparisons were made between the overall treatment effects of the two drugs (including all studies, with fixed and titrated dosage regimens), and between low fixed doses (PRC: 30 μg/day, paricalcitol: 1 μg/day) and high fixed doses (PRC: 60 μg/day, paricalcitol: 2 μg/day).

Nine RCTs, comprising a total of 1,426 patients, were included in the analyses. No statistically significant differences in PTH reduction were found. Paricalcitol showed significantly larger increases in calcium when overall effects and high doses were analyzed. No differences in effects on phosphate were observed. Although effect sizes and statistical significance levels vary somewhat across analyses, the general pattern of similar PTH reductions and larger increases in calcium from paricalcitol are observed in all analyses.

The non-inferiority shown by PRC in lowering PTH and the tendency to increase calcium serum levels observed with paricalcitol treatment indicates that PRC might be used as an equally effective but potentially safer alternative to paricalcitol in treating patients with SHPT.

Endovascular aneurysm repair (EVAR) is routinely used for treatment of abdominal aortic aneurysm (AAA). In 2018, draft guidance from the National Institute for Clinical Excellence (NICE) suggested EVAR was not cost-effective compared to open surgical repair. The analysis was driven by clinical inputs from randomized control trials which may not reflect current clinical practice. Data from registries may inform more robust economic modelling. The Global Registry for Endovascular Aortic Treatment (GREAT) was initiated to collect contemporary real-world data on the performance of GORE® aortic endografts and includes long-term data on survival, re-interventions and resource use. This study compares the real-world values for mortality and resource use following elective EVAR as collected by GREAT with the 2018 NICE AAA draft guidance.

A total of 1,348 patients (88.7% men; mean age 73.1 years) undergoing elective AAA repair with the GORE® EXCLUDER device. Mortality, re-intervention and resource use was compared with the economic inputs for 2018 NICE draft guidance cost-utility analysis.

All patients survived EVAR compared to the 0.4 percent mortality indicated in the NICE analysis. All-cause mortality was lower through 1, 3 and 5 years with values of 6.9, 14.8 and 16.2 percent respectively compared to the NICE base case. The average length of stay was 3.7 days in GREAT compared to 8.34 days in the NICE analysis. Short- and long-term re-interventions were also lower with real-world data (3.6% versus 7.3% and 5.5% versus 8.3%).

GREAT provides conflicting data on survival and resource use associated with EVAR compared to inputs of the 2018 NICE draft guidance These differences are likely to significantly alter incremental cost-effectiveness ratios. Robust cost-effectiveness modelling in health technology assessments should consider contemporary data, as it is likely more reflective of current clinical practice and more informative for clinical and economic decision making for AAA.

Evidence-informed deliberative processes (EDPs) were introduced to guide health technology assessment (HTA) agencies to improve their processes toward more legitimate decision making. A survey among members of the International Network of Agencies for HTA (INAHTA) showed that EDPs can also be relevant for countries that have not (yet) established such an agency. Therefore, we explored to what extent low- and middle-income countries (LMIC) applied the steps and elements stipulated in the EDP framework and their need for guidance.

The survey among INAHTA members was slightly adapted to address LMIC context and sent to 416 experts identified through several HTA sources. The questions focused on contextual factors and the EDP steps (installation of an appraisal committee, selecting technologies and criteria, assessment, appraisal, communication and appeal). Data collection took place between 21 May and 1 September 2019. Descriptive statistics and qualitative analyses were used to summarize the findings.

We received sixty-six meaningful responses from experts in thirty-two LMIC. We found that contextual factors to support HTA development are overall not present or only present to some extent. Respondents indicated that guidance was needed for specific elements related to selecting technologies and criteria, assessment, appraisal, as well as communication and appeal.

EDPs have the potential to provide steps for improving HTA processes. The results of this study can serve as a baseline measurement for future monitoring and evaluation of EDP application in the responding LMIC. This could support the countries in improving their processes and enhancing legitimate decision making when using HTA.

China's National Reimbursement Drug List (NRDL) covers medicines that are included in national health insurance schemes. NRDL updates take into account evidence and recommendations of experts from the fields of medicine, health economics, pharmacy and health policy. A negotiation mechanism between the government and manufacturers was introduced in 2017 to include a more detailed evaluation and negotiation for high cost drugs. However, the values that are considered in NRDL decision making are not well-understood. This study aims to investigate the influence of available evidence and other factors on coverage decisions.

Outcomes of the 2017 and 2018 NRDL negotiations were analyzed. Logistic regression was used to investigate factors associated with listing decisions. Ordinary least squares and Tobit regression were used to investigate factors associated with negotiated price discounts. Independent variables were published cost-effectiveness analysis (CEA), incremental cost-effectiveness ratio (ICER), disease area, burden of disease (disability-adjusted life years), company ownership (domestic or foreign) and regulatory approval year.

Twenty-eight out of sixty-two negotiated drugs had one or more published CEA studies in the English or Chinese language, although neither the presence of a study nor the central ICER estimates were predictive of price discount or listing. A longer time since regulatory approval was a significant predictor of listing (p < 0.05). Disease area (oncology) and ownership (foreign) were significant predictors of a higher price discount (p < 0.01).

The NRDL plays a key role in providing access to healthcare for the 95 percent of China's population that is covered by public insurance. We found several factors that were associated with reimbursement decisions. Many of the medicines in the NRDL negotiation have CEA evidence, although the role of CEA in reimbursement decision making in China remains inconclusive.

The Cochrane Handbook of Systematic Reviews contains two search filters to find randomized controlled trials (RCT) in Ovid MEDLINE: a sensitivity maximizing RCT filter and a sensitivity and precision maximizing RCT filter. The RCT search strategies were originally published in 1994 have been adapted and updated, most recently in 2008. To determine whether the Cochrane filters are still performing adequately to inform Cochrane reviews, we tested the performance of the Cochrane filters and 36 other MEDLINE filters in a large new gold standard set of relevant records.

We identified a gold standard set of RCT reports published in 2016 from the Cochrane CENTRAL database of controlled clinical trials. We retrieved the records in Ovid MEDLINE using their PubMed identifiers. Each RCT filter was run in MEDLINE and combined with the gold standard set of records, to determine their sensitivity, precision and f-scores.

The gold standard comprised 27,617 records and the searches were run on 16 July 2019. The most sensitive RCT filter was Duggan (sensitivity 0.99). The Cochrane sensitivity maximizing RCT filter had a sensitivity of 0.96, but was more precise than Duggan (0.14 compared to 0.04 for Duggan). The most precise RCT filter was Chow, Glanville/Lefebvre, Royle/Waugh, Dumbrique (precision 0.97, sensitivity 0.83). The best precision Cochrane filter was the sensitivity and precision maximising RCT filter.

The Cochrane MEDLINE sensitivity maximizing RCT filter can continue to be used by Cochrane reviewers and CENTRAL compilers as it has very high sensitivity but a more acceptable precision than many higher sensitivity filters. Slightly more sensitive filters are available, but with lower precision than the Cochrane sensitivity maximizing RCT filter. These other filters may be preferred when combining with a subject search when record numbers may be more manageable than searching the whole of MEDLINE.

South Africa's commitment to progressively achieve universal health coverage can lead to the effective and appropriate use of Health Technology Assessment (HTA) to strengthen the healthcare system. The study aimed to analyze the challenges faced in the formal implementation and utilization of HTA in the public health sector.

Review and analysis of health technology policies and legislation introduced in South Africa since 1965 serves as the backbone of this study. Walt and Gilson's health policy triangle framework and Kingdon's model were used for data analysis. In addition, a semi-structured survey was conducted among key stakeholders, including those attending HTA workshops that were held in 2016 and 2017.

The document review identified appropriate legislative and policy framework for informing healthcare decisions. Survey participants (n = 55) reported limited political support, local capacity, and awareness of HTA as barriers to implementing HTA. They noted that adequate financial resources and availability and sharing of quality data are primary drivers for HTA development. Effective governance, collaboration, and cooperation between key stakeholders of the healthcare system were suggested as possible ways forward for the institutionalization of HTA.

The South African government's goal to introduce the national health insurance program provides an excellent opportunity to formally introduce the use of HTA in decision making. Individual capacity development supported by institutional and organizational environments is urgently needed to achieve its full potential.

There are divergent views on the potential of real-world data (RWD) to inform decisions made by regulators, health technology assessment (HTA) bodies, payers, clinicians, and patients. This RWE4Decisions initiative explored the particularly challenging setting of highly innovative technologies, which require Payers/HTAs to make decisions on a small evidence base with major uncertainties. The aim was to go beyond strategic intent to consider actions that each stakeholder could take to improve use of RWD in this setting.

Case studies of recent Payer/HTA decisions about highly innovative technologies were considered in light of recent international initiatives about RWD. This showed a lack of clarity about the Payer/HTA questions that could be answered by RWD and how the quality of real-world evidence (RWE) could be assessed. All stakeholders worked together to create a vision whereby stakeholders agree what RWD can be collected for highly innovative technologies based on principles of collaboration and transparency. For each stakeholder group, recommended actions to support the generation, analysis, and interpretation of RWD to inform decision making were developed. For HTA bodies, this includes cross border HTA/regulatory collaboration to agree RWD requirements over the technology life cycle to inform initial recommendations and reassessment, data analytics methods development for HTA, and promotion of transparency in RWE studies.

Stakeholders need to collaborate on demonstration projects to consider how RWE can be developed to inform healthcare decisions and contribute to a learning network that can develop systems to support a learning health system and improve patient outcomes through best use of RWD.

Data from randomized controlled trials (RCTs) are the primary source for health technology assessment (HTA) however these are limited by strict patient inclusion criteria, leading to concerns about whether treatment benefit estimates are accurate for all patients (generalizability). Real-World Data (RWD) have been proposed as a solution however as these are observational data there is additional potential for bias when estimating treatment effectiveness. To maximize the utility of RWD it is useful to consider the whole process of evidence generation and robustly address issues of feasibility and validity.

A series of complementary studies investigated whether population-based routinely collected health data from Scotland are suitable for estimating the effectiveness of chemotherapy for early breast cancer. Firstly, a prognostic score was validated in this population. Secondly, a comparison of RWD and randomized trial effectiveness estimates was made to investigate feasibility and validity of several methods – Propensity Score Matching (PSM), Instrumental variables (IV) and Regression Discontinuity. Finally, effectiveness estimates in trial underrepresented groups were produced.

PSM and IV were feasible and produced results in relatively close agreement with randomized data. Effectiveness estimates in trial underrepresented groups (women over 70 years and women with high comorbidity) were consistent with an approximate one-third reduction in the risk of death from breast cancer. This is equivalent to approximately a 3–4 percentage point difference in all cause mortality over 10 years in these groups.

RWD are a feasible for generating estimates of effectiveness of adjuvant chemotherapy in early stage breast cancer. The process of using RWD for this purpose should include careful assessment of data quality and comparison of alternative strategies for causal identification in the context of available randomized data.

NICE is undergoing transformational change aiming to improve consistency across the different types of guidance and to bring together related guidance in a more accessible way (NICE Connect). Currently, NICE publishes myriad guidance with different language and formats, which may lead to stakeholder confusion and gaps in the provision of information. Here, the consistency of the format and language of a subset of NICE guidance was assessed to understand where and how guidance could be better aligned. This preliminary investigation is important to determine the extent of inconsistencies and whether a more detailed analysis is warranted.

Ten randomly selected pieces of guidance published (or updated) April 2018 – March 2019 from three programs were assessed (two pieces of guidance or ten percent of guidance per program, whichever was greatest): Medical Technologies (n = 2); Diagnostics (n = 2); Technology Appraisals (n = 6). Guidance was assessed on aspects listed on the guidance webpage (for example, summary type, additional sections, links to other resources, format) and the guidance pdf (for example, table of contents and language). Observed data and trends are described.

The webpage summary and additional sections were consistent within and between programs. Additional information on the webpages showed themes which are not currently standardized (for example, guidance history). In the table of contents only one section was consistently included in all guidance, and the terminology was not consistent across different types of guidance. The format used to present evidence differed between programs (webpage tab or within the pdf), as did terminology for the external assessment groups.

These descriptive data highlight inter- and intra-program inconsistencies in the content and format of NICE guidance, especially in the guidance table of contents and the format and language regarding the provision of evidence. These inconsistencies contribute to the inaccessibility of NICE guidance, making it potentially difficult for patients and professionals to understand guidance, conditions and treatments as a whole.

A more comprehensive analysis is warranted to extend and validate these conclusions. Future research of this kind could constructively direct the resources and priorities of NICE transformational projects, and could lead to an improvement in the accessibility of NICE Guidance.