bluuebunny/crossref_metadata_2025 huggingface dataset:
OP129 The Use Of A Text-Mining Screening Tool For Systematic Review Of Treatments For Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Authors: Carey Niamh , Harte Marie , McCullagh Laura
Published: December 2021

Introduction

Human screening of title and abstracts in a systematic literature review (SLR) is labor intensive and time-consuming. In many instances, thousands of citations may be retrieved; the vast majority excluded upon screening. Text-mining semi-automates and accelerates screening by identifying patterns in relevant and irrelevant citations, as labelled by the screener. One such text-mining tool, Abstrackr, uses an algorithm within an active-learning framework to predict the likelihood of citations being relevant. The objective of this study was to assesses the performance of Abstrackr for title and abstract screening in an SLR of treatments for relapsed/refractory diffuse large B-cell lymphoma.

Methods

Citations identified from searches of electronic databases were imported to Abstrackr. An investigator-selected database of terms indicating relevance of title and abstract to the research question were uploaded. These terms were partly informed by the SLR inclusion/exclusion criteria. Citations deemed most relevant by Abstrackr were screened first (screening prioritization). Screening was carried out until a maximum prediction score of 0.4 or less, based on previous experience in the literature, was reached. Remaining citations were deemed unlikely to be relevant and did not undergo screening (screening truncation). Separately, a single-human screener screened all citations using Covidence.

Results

A total of 7,723 citations and 154 initial terms were uploaded to Abstrackr. Of these citations, 2,572 (33 percent) were screened before a prediction score of 0.39 was reached. Compared to single-human screening (conducted on all citations), the workload saving associated with Abstrackr was 5 days. A total of 451 (6 percent) citations proceeded to full-text screening; ten (0.1 percent) were included in the final evidence base. No citations predicted to be irrelevant by Abstrackr were included in the final evidence base.

Conclusions

Text-mining tools such as Abstrackr have the potential to reduce workload associated with title and abstract screening, without missing relevant citations.
OP135 Impact Of Updated Trial Data On The Cost-effectiveness Of Health Technologies: A Case Study On Percutaneous Mitral Repair
Authors: Armoiry Xavier , Auguste Peter , Obadia Jean-François , Grinberg Daniel , Connock Martin
Published: December 2021

Introduction

Extrapolation methods are commonly used to model the cost-effectiveness of health technologies beyond observed data. Reassessing cost-effectiveness estimates using updated clinical trial data has the potential to reduce uncertainty and optimize decision-making. We present a case study based on percutaneous repair (PR) with the Mitraclip system, a technology to treat severe secondary mitral regurgitation (MR). For the study purpose, we considered the COAPT trial that evaluated the effectiveness of adding PR to medical treatment versus medical treatment alone.

Methods

We developed a time-varying Markov model to assess the cost-effectiveness of PR. Clinical inputs were based on reconstructed individual patient data from the COAPT trial results reported at 2 years, and at 3 years.

We developed parametric modeling for overall survival (OS) and heart failure hospitalizations (HFH) to obtain clinically plausible extrapolations beyond observed data. We adopted the French perspective and used a 30-year time horizon. We expressed incremental cost-effectiveness ratios (ICERs) as cost per quality-adjusted life year (QALY).

Results

Based on 2 year-data, preferred parametric models for OS and HFH were exponential and log-logistic respectively, yielding an ICER of EUR21,918/QALY and >0.5 probability of PR being cost-effective (EUR50,000/QALY threshold).

Updated analyses at 3 years showed a change of OS trajectory for PR that justified the use of piecewise modelling, yielding an updated ICER that went up to EUR77,904/QALY (base-case), and to a minimum of EUR58,175/QALY (scenario analysis). Using data at 3 years, PR had <0.5 probability of being cost-effective.

Conclusions

In this case study, the availability of updated survival analyses of the main trial is likely to have some impact on decision-making and/or pricing discussion as part of health-technology assessment (HTA). We aim to provide further updated analyses as 4 years results of the COAPT study become available.

More broadly, original technology appraisals are frequently undertaken when mid/long-term follow-up trial data may be lacking. Our example suggests the need for continuous HTA review as new clinical data are released.
OP164 Extracorporeal Cytokine Adsorption Therapy: An Update Systematic Review Of Clinical Efficacy And Safety For Two Indications
Authors: Goetz Gregor , Hawlik Katharina , Wild Claudia
Published: December 2021

Introduction

The idea of using extracorporeal cytokine adsorption therapy (ECAT) is to remove cytokines from the blood in order to restore a balanced immune response. Yet, it is unclear as to whether the use of ECAT improves patient-relevant outcomes. Hence, the aim of this article is to synthesize the currently available evidence with regard to a potential clinical benefit of ECAT used in cardiac surgery or sepsis.

Methods

We conducted an updated systematic review summarizing the body of evidence with regard to a potential clinical benefit of ECAT. The study followed the PRISMA statement and the European Network for Health Technology Assessment (EUnetHTA) guidelines. The quality of the individual studies and the strength of the available evidence was assessed using the Cochrane risk of bias tool (v.1) and the GRADE approach respectively. Mortality, organ function, length of stay in the intensive care unit and length of hospitalization, as well as adverse events, were defined as critical outcomes.

Results

For the preventive treatment of ECAT in patients undergoing cardiac surgery, we found very low-quality inconclusive evidence for mortality (5 randomized controlled trials (RCTs), n = 163), length of stay in the intensive care unit (5 RCTs, n = 163), and length of hospitalization (3 RCTs, n = 101). In addition, very low-quality inconclusive evidence was found for (serious) adverse events (4 RCTs, n = 148). For the therapeutic treatment of ECAT in patients with sepsis/ septic shock, we found very low-quality inconclusive evidence for mortality up to 60-day follow-up (2 RCTs, n = 117), organ function (2 RCTs, n = 117) and length of stay in the intensive care unit (1 study, n = 20). Similarly, very low-quality inconclusive evidence was found for (serious) adverse events (2 RCTs, n = 117). There are currently eighteen ongoing RCTs on the use of ECAT.

Conclusions

There is a lack of reliable data on the clinical benefit of using ECAT as an add-on treatment preventively in cardiac surgery and therapeutically in patients with sepsis or septic shock. While theoretical advantages are anticipated, the current available evidence is inconclusive and was not able to establish the efficacy and safety of ECAT in combination with standard care in the investigated indications. In light of the available RCTs, we strongly recommend the consideration of studies with patient-relevant endpoints and adequate statistical power, instead of investing further research funds on small studies that may not shed more light onto the potential clinical benefit of ECAT. The results of ongoing RCTs are awaited to guide the decision on whether further research funds should be invested in ECAT research or to conclude that the intervention may not show clinical benefits for patients.
OP179 Quantitative Evidence Synthesis Methods For Assessing The Effectiveness Of Treatment Sequences For Clinical And Economic Decision-Making: Methodology Review
Authors: Lewis Ruth , Hughes Dyfrig , Sutton Alex , Wilkinson Clare
Published: December 2021

Introduction

The sequential use of alternative treatments for chronic conditions represents a complex, dynamic intervention pathway; previous treatment and patient characteristics affect both choice and effectiveness of subsequent treatments. Evidence synthesis methods that produce the least biased estimates of treatment-sequencing effects are required to inform reliable clinical and policy decision-making. A comprehensive review was conducted to establish what existing methods are available, outline the assumptions they make, and identify their shortcomings.

Methods

The review encompassed both meta-analytic techniques and decision-analytic modelling, any disease condition, and any type of treatment sequence, but not diagnostic tests, screening, or treatment monitoring. It focused on the estimation of clinical effectiveness and did not consider the impact of treatment sequencing on the estimation of costs or utility values.

Results

The review included ninety-one studies. Treatment-sequencing is usually dealt with at the decision-modelling stage and is rarely addressed using evidence synthesis methodology for clinical effectiveness. Most meta-analyses are of discrete treatments, sometimes stratified by line of therapy. Prospective sequencing trials are scarce. In their absence, there is no single best way to evaluate treatment sequences, rather there is a range of approaches, each of which has advantages and disadvantages and is influenced by the evidence available and the decision problem. Due to the scarcity of data on sequential treatments, modelling studies generally apply simplifying assumptions to data on discrete treatments. A taxonomy for all possible assumptions was developed, providing a unique resource to aid the critique of decision-analytic models.

Conclusions

The evolution of network meta-analysis in HTA demonstrates that clinical and policy decision-making should account for the multiple treatments available for many chronic conditions. However, treatment-sequencing has yet to be accounted for within clinical evaluations. Economic modelling is often based on the simplifying assumption of treatment independence. This can lead to misrepresentation of the true level of uncertainty, potential bias in estimating the effectiveness and cost effectiveness of treatments and, eventually, the wrong decision.
OP181 Adapting Evidence To Produce A Health Technology Assessment Of Mammography Screening: An Example From The West Bank
Authors: Heupink Lieke Fleur , Isbeih Mervett , Qaddomi Sharif , Peacocke Elizabeth , Sæterdal Ingvil , Salman Rand , Chola Lumbwe
Published: December 2021

Introduction

Health technology assessment (HTA) can play a key role in evidence-based decision-making. However, HTA requires resources that might be lacking in low-income settings. To test the feasibility of adapting existing evidence as part of the HTA process, this project evaluated the effectiveness and economic impact of breast cancer screening programs for women over 40 years in the West Bank, where mammography screening is provided for free in governmental clinics.

Methods

We conducted a search for systematic reviews, HTAs and guidelines in electronic databases. We included the most recent global systematic review and meta-analysis that fulfilled our inclusion criteria. The European Network for Health Technology Assessment (EUnetHTA) adaptation toolkit was used to guide adaptation and undertake a budget impact analysis of the economic impact of mammography screening. We build capacity by working as a team of HTA experts and first-time HTA researchers. The results were disseminated to raise awareness for HTA.

Results

The European Commission Guidelines on Breast Cancer Screening were identified as most recent global systematic review with meta-analyses, out of 2,365 references. The adapted evidence may inform policies on screening in the West Bank. Our experience is that adaption requires extensive skills and resources, including finding, assessing, and adapting relevant evidence. The EUnetHTA toolkit is useful, but also adds to the workload. Furthermore, local stakeholder engagement is important in topic selection, to access information, and to contextualize global evidence to the local setting.

Conclusions

This study is currently ongoing, but preliminary findings show that producing an HTA by adapting existing evidence in resource-limited settings is feasible. There is a need for nuanced guidance on transferability of evidence from other settings. Future studies should investigate innovative methods to optimize the adaption process. Capacity building in adaptation is important to ensure the production of quality HTA products. Inclusion of local team members and stakeholders is important for future development of HTA in the region.
OP220 What Factors Do Clinicians Value Most In Selecting Physician Preference Items? A Survey Among Italian Orthopaedists
Authors: Armeni Patrizio , Meregaglia Michela , Borsoi Ludovica , Callea Giuditta , Torbica Aleksandra
Published: December 2021

Introduction

Physician preference items (PPIs) are high-cost medical devices on which clinicians express firm preferences with respect to a particular manufacturer and a specific product. The aim of this research is to understand what are the most important factors, as well as their relative importance, in the choice of new PPIs (that is, hip or knee prosthesis) adoption on behalf of orthopaedic clinicians in Italy.

Methods

Based on a literature review and clinical experts’ opinions, we identified a number of key factors (for example, health technology assessment (HTA) recommendation) and their corresponding levels (for example positive HTA recommendation). We administered an online survey to hospital orthopaedists using two experimental techniques for preference elicitation (that is, discrete choice experiment (DCE) and case 1 best-worst scaling (BWS)). BWS data were analysed through descriptive statistics (that is, best-minus-worst score) and conditional logit model. A mixed logit model was applied to DCE data, and a willingness-to-pay (WTP) was estimated. All analyses were conducted using Stata 16.

Results

A total of ninety orthopaedists (95% male; mean age: 52.8 years) were enrolled in the survey. In BWS, the most important factor was ‘clinical evidence’, followed by ‘quality of products’, ‘HTA recommendations’ and ‘previous experience’, while the least important was ‘cost’. DCE results suggested that orthopaedists prefer high-quality products with robust clinical evidence, positive HTA recommendation and affordable cost, and for which clinicians have a consolidated experience of use and a good relationship with the sales representative. The WTP for a high-quality product was estimated at EUR1,733, and for a good relationship at EUR2,843.

Conclusions

This is the first study aimed at analysing the multidimensionality of clinician's decision-making process in selecting new PPIs in orthopaedics in Italy. Despite the quality of products being declared as one of the most important dimensions in BWS, when other factors populate a hypothetical DCE scenario, physicians are not willing to accept quality at any cost (for example, high quality and very bad support from the producer or with uncertain clinical evidence).
OP223 A Semi-Automated Process To Monitor The Clinical Development And Regulatory Approval Pathway Of Innovative Medicines
Authors: Wilkins Georgina , Zanghelini Fernando , Brooks Kieran , Ogunbayo Oladapo
Published: December 2021

Introduction

Early identification of innovative medicines is crucial for timely health technology assessment (HTA) and efficient patient access. The National Institute for Health Research Innovation Observatory (NIHRIO) identifies, monitors and notifies key HTA stakeholders in England of ‘technologies’ (innovative medicines) within three to five years of regulatory approval. Increasing numbers of innovative medicines and significant uncertainties in clinical and regulatory pathways are major challenges in the monitoring and notification process. An active monitoring framework using pre-defined predictive criteria has previously been developed. This framework provides a standardized and consistent process, but is highly resource-intensive, requiring manual review of individual records.

Methods

Using the previous active monitoring framework, a scoring matrix was calculated and used to prioritize individual technologies using available data in the NIHRIO database: estimated regulatory timelines, regulatory awards/designations, innovative medicine type (for example gene therapies) and clinical trial phase, completion dates and results. A threshold for automatic and manual reviewing of technologies was developed and tested by NIHRIO analysts.

Results

The scoring system identified approximately ninety percent of technologies meeting the threshold for semi-automated reviewing. The review period for these technologies are set automatically according to predefined criteria depending on data availability. The review periods are updated automatically until the record reaches the threshold that triggers manual reviewing. The remaining ten percent had estimated regulatory timelines necessitating the need for manual reviewing and early engagement with companies to verify regulatory timelines and/or notify HTA stakeholders.

Conclusions

Preliminary analysis indicates that each technology is routinely and automatically updated. The semi-automatic updating represents a significant improvement in the efficiency of the monitoring of the large volume of technologies on the NIHRIO database. Ongoing work is being undertaken to further refine, pilot and test the system.

This project is funded by the NIHR [(HSRIC-2016-10009)/Innovation Observatory]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
OP227 Exploring The Value Of Soft-Intelligence: A Case Study Using Twitter To Track Mental Health During The COVID-19 Pandemic
Authors: Marshall Christopher , Lanyi Kate , Green Rhiannon , Wilkins Georgina , Pandey Savitri , Craig Dawn
Published: December 2021

Introduction

There is increasing pressure to rapidly shape policies and inform decision-making where robust evidence is lacking. This work aimed to explore the value of soft-intelligence as a novel source of evidence. We deployed an artificial intelligence based natural language platform to identify and analyze a large collection of UK tweets relating to mental health during the COVID-19 pandemic.

Methods

A search strategy comprising a list of terms relating to mental health, COVID-19 and the lockdown was developed to prospectively identify relevant tweets via Twitter's advanced search application programming interface. We used a specialist text analytics platform to explore tweet frequency and sentiment across the UK and identify key topics of discussion for qualitative analysis. All collated tweets were anonymized.

Results

We identified 380,728 tweets from 184,289 unique users in the UK from 30 April to 4 July 2020. The average sentiment score was fifty-two percent, suggesting overall positive sentiment. Tweets around mental health were polarizing, discussed with both positive and negative sentiment. For example, some people described how they were using the lockdown as a positive opportunity to work on their mental health, sharing helpful strategies to support others. However, many people expressed the damaging impact the pandemic (and resulting lockdown) was having on their mental health, including worsening anxiety, stress, depression, and loneliness.

Conclusions

The results suggest that soft-intelligence is potentially a useful source of evidence. The approach taken to identify and analyze this data may offer an efficient means of establishing key insights from the ‘public voice’ relating to critical health issues. However, there are still various limitations to consider concerning the technology and representativeness of the data. Future work to explore this type of evidence further, and how it might formally support decision-making processes, is recommended.

This project is funded by the NIHR [(HSRIC-2016-10009)/Innovation Observatory]. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
OP242 Patient-based Evidence: A Comparison Of The Views Of Patient And Clinical Engagement Participants And Committee Members
Authors: Hems Sharon , Taylor Louise , Jones Jan , Holmes Eileen
Published: December 2021

Introduction

The Scottish Medicines Consortium (SMC) conducts early health technology assessment (HTA) of new medicines on behalf of NHSScotland. Evidence from patients and carers on end-of-life and orphan medicines is gathered during Patient and Clinician Engagement (PACE) meetings. The output is a consensus statement describing a medicine's added value from the perspective of patients/carers and clinicians, which is used by SMC committee members in decision-making. This study compared the importance of factors in the PACE statement to PACE participants and committee members.

Methods

A survey of ninety-eight PACE participants (consisting of forty-two patient group (PG) representatives and fifty-six clinicians) investigated the importance of quality of life (QoL) themes (family/carer impact, health benefits, tolerability, psychological benefit, hope, normal life, treatment choice and convenience) identified from an earlier thematic analysis of PACE statements. The findings from PG representatives and clinicians were compared, and the overall results were further compared with those from a previous survey of committee members (n = 26).

Results

Among PACE participants who responded (twenty-six PG representatives and fourteen clinicians), 100 percent rated ‘health benefits’ and ‘ability to take part in normal life’ as important / very important. ‘Convenience of administration’ and ‘treatment choice’ received the lowest rating with fifteen percent and nineteen percent respectively of PG representatives versus seven percent of clinicians rating each as very important. ‘Hope for the future’ received the most diverse response with fifty-eight percent of PG representatives and fourteen of clinicians rating this as very important.

In general, PACE participants rated importance of QoL themes higher than committee members (n = 21) but the rank order was similar. Differences between the proportion of PACE participants and committee members who rated themes important/very important was greatest for ‘treatment choice’ (sixty-seven percent versus twenty percent respectively) and ‘hope for the future’ (eighty-two percent versus fifty-three percent).

Conclusions

The findings demonstrate some alignment between PACE participants’ and committee members’ responses, supporting the value of the PACE output in decision-making. Areas for further research are highlighted.
OP248 A Minimum Data-Set For Left Ventricular Assist Device On Destination Therapy: Cross-Border Collaboration Pilot On Real World Data
Authors: Varela-Lema Leonor , Puñal-Rioboo Janet , Faraldo Vallés María José
Published: December 2021

Introduction

The European Health Technology Assessment Network (EUnetHTA) Work Package 5B1, is focused on testing the levels of cross-border collaboration on real world data for supporting reimbursement/pricing decision-making. Within this Work Package, we are conducting a pilot on Left Ventricular Assist Device on destination therapy in collaboration with the National Institute for Health and Care Excellence (NICE, UK), the Belgian Health Care Knowledge Centre (KCE, Belgium) and the Italian National Agency for Regional Health Services (AGENAS, Italy). This pilot aims to define the minimum data set for gathering and sharing high quality registry data on key uncertainties found at the time of the health technology assessment (HTA). Furthermore, the pilot will assess the feasibility of carrying out a common analysis or reusing this data for National or Joint Reassessments.

Methods

Evidence gaps were based on the four national assessments. Collaborating partners were responsible for agreeing on the key outcomes and proposing the minimum dataset to be registered. European clinical experts and patients rated and prioritized the dataset using a two round Delphi technique (not relevant, important but not critical; critical). The dataset will confirm the basis for the Spanish LVAD registry, implemented at the national health service level to inform inclusion into the healthcare portfolio.

Results

The key outcomes agreed upon by agencies relate to safety, effectiveness, satisfaction and acceptability of the patient and cost-effectiveness, budget impact and organizational impact. Expert cardiologists and cardiac surgeons representing the European and Spanish Society, among others, participated in the prioritization of basic data. The final dataset is expected by December 2020.

Conclusions

The variation in the quality and definition of outcome measures for measuring key evidence gaps reduces the utility of registries for HTA, making it difficult to compare, link, and aggregate data across countries. The EUnetHTA pilot is intended to offer a model for cross-border collaboration on real world data for supporting the decision-making process for pricing and reimbursement.
OP256 Recognising The Broader Value Of Vaccines In Health Technology Assessment: Worth A Shot?
Authors: Neri Margherita , Brassel Simon , Steuten Lotte
Published: December 2021

Introduction

The COVID-19 pandemic shows that the impact of effective vaccines extends well beyond vaccinated individuals and healthcare systems. Yet, these externalities are not typically considered in health technology assessments (HTA) which may underestimate vaccines’ broader value. We explored to what extent future vaccines relevant to England might exhibit such broader value.

Methods

We compared the ten value elements of an existing vaccine evaluation framework to the value elements considered in England according to the Joint Committee on Vaccine and Immunisation (JCVI) and the National Institute for Health and Care Excellence's (NICE) guidelines. Using literature and expert opinion we then explored, for a selection of ten vaccines with an expected UK-launch within five years, on which value elements each vaccine might potentially show added value.

Results

Up to five of ten value elements are unlikely to be considered by JCVI or NICE, including patient and carer productivity, enablement value, impact on antimicrobial resistance and transmission value. Of vaccines studied, 100 percent will potentially generate value on at least one broader value element that is currently ignored; 60 percent to 80 percent may increase vaccinee/patient or carer productivity respectively.

Conclusions

There is a substantial gap between value generation and value recognition of vaccines in HTA in England. This might lead to undervaluation and underutilization of vaccines, leaving societies more vulnerable than needed when faced with infectious diseases.
OP267 Evidence for Health Technology Assessment: The Capability Approach
Authors: Rijke Wouter , Vermeulen Anneke , Blom Helen , Willeboer Krista , Mylanus Emmanuel , Langereis Margreet , van der Wilt Gert Jan
Published: December 2021

Introduction

Healthcare services, such as cochlear implants and subsequent rehabilitation, aim to increase valuable activities and opportunities of those affected. Their impact may be inferred from the extent that they protect or restore capability, which reflects the real freedoms that people have to be or do things they have reason to value. Capability emerges from the dynamic interaction between available resources, individual, social, and environmental conversion factors, and functionings. This model sets the informational requirements of the capability approach.

Methods

On the basis of interviews with thirty-three hearing impaired children and thirty hearing peers, information on capability elements (values, resources, conversion factors, and functionings) was collected. Qualitative results were triangulated with standardized clinical audiological and psycholinguistic quantitative measures.

Results

Hearing impaired children and their hearing peers concurred in terms of the doings and beings they valued, but differed in terms of conversion factors to realize capability. Parents of hearing impaired children played a more upfront role, hearing impairment predominated many areas of life, and communicating through hearing aids required more energy than was usually acknowledged by the people around them.

Conclusions

The capability approach offers opportunities not only to assess impact of technology on dimensions that are important to patients, but also to better understand the mechanisms that are involved in value generation.
OP305 A Systematic Approach To Include Ethical Aspects In Health Technology Assessments – Experiences And Evaluation
Authors: Ramsay Karin Willbe
Published: December 2021

Introduction

The Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) is commissioned to assess ethical aspects in their health technology assessment (HTA) reports, in addition to effects and health economic aspects of the examined interventions. For this purpose, a framework for systematic evaluation of ethical aspects of healthcare technologies has been developed and used at SBU since 2014. With seven years of practice, we decided it was time to evaluate experiences from using the ethical framework and consider possible adjustments to improve future use.

Methods

SBU reports in the time period 2014–2020 were systematically screened for ethical content. Focus group meetings with users of the framework (mainly HTA project managers) were held where opinions regarding usability and possible obstacles were collected. A revised version of the document was sent for consultation to relevant stakeholders (possible users, reviewers and recipients) in order to collect additional views.

Results

Of fifty-eight HTA reports produced in the time frame, ethical aspects were evaluated in fifty-five reports (ninety-five percent), and in most cases, the framework had been used as support. In twenty-one cases (thirty-six percent), a professional ethicist had been engaged in the work. In twelve cases (twenty-one percent), ethical aspects were presented in the main conclusions of the report. Opinions from users and reviewers revealed that the framework was generally regarded as a helpful tool, but problems regarding interpretation of specific questions were highlighted and subjected to revision.

Conclusions

The ethical framework is a valuable tool for systematic and transparent identification and discussion of ethical aspects in the HTA context, and it has been well implemented at SBU. A systematic approach to assess ethical aspects can facilitate the communication and dissemination of ethical aspects as principal results from the HTA project.
OP339 Virtual COVID Ward: The Use Of Telehealth In The Emergency Response To COVID-19
Authors: Rezgui Abdel Hakim , Harkness Rosemary , Law Hou , Thomson David , Towns Rebecca
Published: December 2021

Introduction

With unprecedented times, comes accelerated change. Hospitals in our region have begun to facilitate safe discharge for COVID-19 patients in the form of “The virtual COVID ward”. This has enabled patients to be monitored safely in the community using pulse oximetry, Florence (a telehealth mobile app) and remote consultations. Our objective is to expand upon this model by providing home oxygen therapy for these patients facilitated by telemedicine.

Methods

Patients were discharged with an oxygen concentrator if they had an oxygen requirement equal to or less than four litres/minute. Fraction of inspired oxygen needed to be stable and an early warning score of less than four was also required. Once admitted, the Florence app and daily remote consultations were crucial to closely monitor the patient's clinical status. The patient was instructed to enter oxygen saturations and heart rate into the app four times daily. The app would then alert our team if any patients observations deteriorate, triggering immediate assessment.

Results

We have discharged ninety patients to the virtual ward, fifty-six of these with home oxygen. The average age was fifty-seven and the Clinical Frailty Score ranged between one and six. At present, ten patients have been re-admitted, four with increasing oxygen requirements, and six with unrelated symptoms. Two patients had oxygen concentrators installed at home after we were alerted to their desaturation by the Florence App. The re-admission rate is eleven percent, which mirrors that of other virtual wards (who do not provide home oxygen). In total, the ward has saved the trust 627 hospital inpatient ‘days’. Patients report increased satisfaction at playing a meaningful role in monitoring their own healthcare using the app.

Conclusions

Our novel model of supported discharge with oxygen therapy using telehealth demonstrates that it is possible to manage such patients, safely, in the community. Other trusts could utilise this model to reduce inpatient bed occupancy. Looking to the future, could telehealth be utilised further to facilitate other “Virtual wards” in the community?
OP443 Evaluating The Value Of Endovascular Innovations For Aortic Valve Replacement Through Clinical Benefits, Patient-reported Outcomes And Resource Consumption.
Authors: Pinar Eduardo , de Lara Juan García , Hurtado José , Robles Miguel , Leithold Gunnar , Martí-Sánchez Belén , Cerezales Mónica , Cuervo Jesús
Published: December 2021

Introduction

The use of most recent Transcatheter aortic valve implants (TAVI) in the treatment of symptomatic severe aortic stenosis (SAS) is evolving with expanded indications from inoperable/high-risk to intermediate and low risk patients. Consequently, TAVI outcomes must be monitored to highlight its value under real-world conditions. Our aim was to prospectively evaluate TAVI (SAPIEN 3) outcomes in terms of patient's health-related quality of life (HRQoL), clinical outcomes, and healthcare resource utilization (HRU).

Methods

An observational prospective study including all consecutive patients with SAS undergoing a transcatheter valve implantation with Edwards SAPIEN 3 valve (transfemoral access) was conducted in full accordance with clinical guidelines from the European Society of Cardiology. Patients were evaluated before the intervention (baseline), at discharge, and after one, six and twelve months from the implant. A thoughtful and systematic evaluation of patients’ HRQoL (EQ-5D 5L, the Short Form-36 Health Survey -SF-36- and the Kansas City Cardiomyopathy Questionnaire -KCCQ-), clinical endpoints (that is, cardiovascular mortality, and rates of stroke, major bleeding, myocardial infarction, and re-hospitalization), echocardiographic measurements, and HRU (that is, Length of stay-LOS- in ward/intensive care unit -ICU-) was implemented. Multivariate regression models were applied to test outcomes while controlling key risk factors (that is, patient’ severity at baseline).

Results

A total of seventy-six patients (fifty percent female, fifty-five percent of intermediate-high risk) with a mean age of 82.1 ± 4.78 years were included. Implant success was 97.34% and cardiovascular death was 2.6% at one year. Significant reductions in mean and maximum gradients were achieved and maintained during follow-up. Mean LOS in ward (5.2 ± 4.0days) and ICU (0.22 ± 0.64 days) were low. Statistically significant improvements were detected in the KCCQ overall summary scores, EQ-5D, and SF-36 (Physical component summary) - all adjusted - p < 0.05 - after the intervention.

Conclusions

TAVI represents a safe and effective innovation for SAS with clinical benefits translated into significant improvements in terms of HRQoL. Besides, the low HRU provides new insights for health-economic modelling and the optimization of limited resources of special importance under current pandemic situation.
PP100 Characteristics To Consider In A Knowledge Translation Theory, Model Or Framework For Health Technology Reassessment
Authors: Esmail Rosmin , Hanson Heather M. , Holroyd-Leduc Jayna , Niven Daniel J. , Clement Fiona M.
Published: December 2021

Introduction

Health technology reassessment (HTR) is a structured evidence-based assessment of an existing technology in comparison to its alternatives. The process results in the following four outputs: (i) increased use; (ii) decreased use; (iii) no change; or (iv) de-adoption. However, implementing these outputs remains a challenge. Knowledge translation (KT) can be applied to implement findings from the HTR process. This study sought to identify which characteristics of KT theories, models, and frameworks (TMFs) could be useful, specifically for decreasing the use of or de-adopting a technology.

Methods

A qualitative descriptive approach was used to ascertain the perspectives of international KT and HTR experts on the characteristics of KT TMFs for decreasing the use of or de-adopting a technology. One-to-one semi-structured interviews were conducted. Interviews were audio recorded and transcribed verbatim. Themes and sub-themes were deduced from the data through framework analysis using the following five distinctive steps: familiarization; identifying an analytic framework; indexing; charting; and mapping and interpretation. Themes and sub-themes were also mapped to existing KT TMFs.

Results

Thirteen experts participated. The following three themes emerged as ideal characteristics of a KT TMF: (i) principles foundational for HTR: evidence-based, high usability, patient-centered, and ability to apply to micro, meso, and macro levels; (ii) levers of change: characterized as positive, neutral, or negative influences for changing behavior; and (iii) steps for knowledge to action: build the case for HTR, adapt research knowledge, assess context, select, tailor, and implement interventions, and assess impact. The Consolidated Framework for Implementation Research had the greatest number of ideal characteristics.

Conclusions

Application of KT TMFs to the HTR process has not been clearly established. This is the first study to provide an understanding of characteristics within KT TMFs that could be considered by users undertaking projects to decrease or de-adopt technologies. Characteristics to be considered within a KT TMF for implementing HTR outputs were identified. Consideration of these characteristics may guide users in choosing which KT TMF(s) to use when undertaking HTR projects.
PP112 Review On Change Management Models In Multi-Lateral, Multi-Stakeholder Contexts To Engage Stakeholders
Authors: Lokhorst Ayla , Hogervorst Milou
Published: December 2021

Introduction

To facilitate implementation of new health technology assessment (HTA) methods, it is crucial to engage stakeholders. A technically good system may be brought to its knees if the intended users are not willing or able to use it. Therefore, based on these considerations, we aimed to identify relevant aspects of change models and investigated four potentially useful change models in the context of HTA. The four models were: adaptive space; midstream modulation; developmental evaluation; and knowledge brokering.

Methods

A narrative literature review was conducted to gather information into a readable and usable format. PubMed and Google Scholar were searched for relevant literature on change management and stakeholder engagement within HTA. Additionally, grey literature was selected after consulting an implementation specialist to gather more information on the background of the change management models.

Results

Several enabling factors for successful stakeholder engagement were found, including attention to branding of the coproduction, facilitation/personal safety, and data or indicators to inform activities. Four change methods were described from the enabling factors identified. There was no “perfect model” for our aim, but all models involved relevant aspects to engage stakeholders. Notably, all models paid attention to the project management factor, whereas none of the models paid explicit attention to the branding of the coproduction factor.

Conclusions

Change management is a complex and elaborate field in which many factors play a role. Stakeholder engagement is a factor that might be influenced by project leaders within international projects such as the European Union's Next Generation Health Technology Assessment (HTx). To improve stakeholder engagement in modernizing HTA, it is important to keep paying attention to project management, relationships, and how to facilitate fora and meetings to improve mutual understanding. Two factors to pay more attention to are branding of the coproduction and consideration of formal structures.
PP118 A Survival Analysis Of The Lag Times In The Publication Of Network Meta-Analyses
Authors: Tonin Fernanda S. , Araujo Ariane G. , Fachi Mariana M. , Pontarolo Roberto , Fernandez-Llimos Fernando
Published: December 2021

Introduction

The use of inconsistent and outdated information may significantly compromise healthcare decision-making. We aimed to assess the extent of lag times in the publication and indexing of network meta-analyses (NMAs).

Methods

Searches for NMAs on drug interventions were performed in PubMed (May 2020). Lag times were measured as the time between the last systematic search and the date of the article's submission, acceptance, online publication, indexing, and Medical Subject Heading (MeSH) allocation. Correlations between lag times and time trends were calculated by means of Spearman's rank correlation coefficient. Time-to-event analyses were performed considering independent variables such as geographical origin, journal impact factor, Scopus CiteScore, and open access status.

Results

We included 1,245 NMAs. The median time from last search to article submission and publication was 6.8 months and 11.6 months, respectively. Only five percent of authors updated their literature searches after submission. There was a very slight decreasing historical trend for acceptance (r =−0.087; p = 0.01), online publication (r =−0.08; p = 0.008), and indexing lag times (r =−0.080; p = 0.007). Journal impact factor influenced the MeSH allocation process (log-rank p = 0.02). Slight differences were observed for acceptance, online publication, and indexing lag times when comparing open access and subscription journals.

Conclusions

Authors need to update their literature searches before submission to reduce evidence production time. Peer reviewers and editors should ensure that authors comply with NMA standards and encourage the development of living meta-analyses.
PP126 Radiofrequency Ablation For Metastatic Spinal Lesions
Authors: Torres-castaño Alezandra , Rivero-Santana Amado , Perestelo-Pérez Lilisbeth , Toledo-chávarri Ana , Duarte-Diaz Andrea , Alvarez-Perez Yolanda , Ramos-García Vanesa , Serrano-Aguilar Pedro
Published: December 2021

Introduction

About 70 percent of metastatic breast, lung, and prostate cancers affect the bones. When this phase of the disease affects the spine, the mobility and quality of life of patients are severely impaired. Radiofrequency ablation (RFA) has become a feasible option in the palliative treatment of vertebral metastases due to its minimal invasiveness and short procedure time. This health technology assessment report aimed to identify, evaluate, and synthesize evidence on the safety, effectiveness, and cost effectiveness of RFA for vertebral metastases.

Methods

A systematic search was conducted to identify literature published from December 2016 to July 2019 in the following databases: Medline, Embase, the Cochrane Library, and the Centre for Reviews and Dissemination. Systematic reviews, randomized and non-randomized controlled trials, and case series studies evaluating the efficacy and safety of RFA in patients with vertebral metastases were included.

Results

Sixteen studies were included: two systematic reviews, 13 case series studies, and one comparative study. None of the systematic reviews identified any randomized controlled trials. Of the 14 included primary studies, 10 evaluated RFA in combination with vertebroplasty, three evaluated RFA in combination with kyphoplasty, and one study evaluated a combination of RFA and radiation therapy. In all cases, the evaluated patients had different types of cancer (e.g., breast, lung, or liver). The follow-up periods varied between the studies from one day to 12 months. The most commonly used RFA devices were the STAR™ Tumour Ablation System (Merit Medical Systems) and the OsteoCool™ Radiofrequency Ablation System (Medtronic).

Conclusions

RFA reduces pain, improves functional capacity, and provides greater local control of disease, potentially giving patients a higher quality of life, even in the context of metastatic disease. Although there is evidence on the safety and efficacy of this technology for the palliative treatment of vertebral metastases, more studies with higher methodological quality are needed. There were no studies available on the cost effectiveness of RFA for this indication.
PP133 Developing A Novel Multifaceted Graphical Visualization For Treatment Ranking Within An Interactive Network Meta-Analysis Application
Authors: Nevill Clareece , Cooper Nicola , Sutton Alex
Published: December 2021

Introduction

Network meta-analysis (NMA) is a key methodology for comparing the effectiveness of multiple interventions or treatments simultaneously. This project aimed to ascertain current methods and visualizations for treatment ranking within an NMA framework and to subsequently develop a novel graphic within MetaInsight (an interactive NMA web application), to aid clinicians and stakeholders when making decisions regarding the “best” intervention(s) for their patient(s).

Methods

Current literature on the methodology or visualization of treatment ranking published in the last 10 years was collated and studied. Based on the literature, a novel graphical visualization was developed using RShiny (RStudio, PBC) and integrated within MetaInsight, which is currently hosted on shinyapps.io.

Results

Bayesian analyses produce rank probabilities from which mean or median rank and surface under the cumulative ranking curve can be calculated. For frequentist analyses the p-value is available. The simpler methods may be easier to interpret, but they are often more unstable and do not encompass the whole analysis (and vice versa). To aid interpretation and facilitate sensitivity analysis, an interactive graphic was developed that presents rankings alongside treatment effect and study quality results.

Conclusions

Treatment ranking is useful, but the results should be interpreted cautiously, and the visualization should be transparent and all-encompassing. A ‘living’ version of MetaInsight, with treatment ranking, would allow interested parties to follow the evidence base as it grows.