bluuebunny/crossref_metadata_2025 huggingface dataset:
OP279 Data Protection In The European Union Post-General Data Protection Regulation (GDPR): A Barrier Or An Enabler Of Pharmaceutical Innovation?
Authors: Cole Amanda , Towse Adrian
Published: December 2021

Introduction

The expansion of health data offers exciting opportunities to support better and more efficient drug discovery, development and implementation. Data protection and governance provide the legal framework to balance safeguarding patients’ privacy with the benefits to society of medical research. Our aim is to highlight current legal barriers to the better use of health data and propose ways to address them.

Methods

Analysis of the relevant legislative texts was supplemented by interviews with external experts in data protection, health research, informatics and cyber security and a workshop with pharmaceutical industry members. We investigated the legal issues arising for six key activities along the pharmaceutical lifecycle, from identifying unmet need through to health technology assessment and pharmacovigilance.

Results

The General Data Protection Regulation (GDPR) was introduced in May 2018 to Harmonise data protection across Europe. However, considerable ambiguity remains, particularly around the appropriate legal bases for data processing in the absence of consent: scientific research, public interest, or provision of health or social care. Other key themes included data subject rights, anonymization, compatibility of primary and secondary (re-)use of data, heterogeneity arising from divergent interpretation, the need for guidance on digital health, and the importance of trust.

Conclusions

We speculate which legal bases are most appropriate for the six pharmaceutical activities studied, but clear guidance and consensus is required. The GDPR was not designed to hamper scientific research, and the issues identified arose from uncertainties rather than barriers per se. Industry and academic researchers should therefore deal proactively with the prevailing uncertainties, share good practice, and engender trust by co-creating a code of conduct and outlining principles of responsible use. Engagement with patients will be critical in encouraging a shared understanding of the value to society of health data for research.
OP303 Do You Get The Message? Making HTA Findings Easier For Decision-Makers To Implement
Authors: Kandulu Jess , Clifton Ed , Robertson Iain , Smart Neil , Macpherson Karen
Published: December 2021

Introduction

Often health technology assessment (HTA) products developed by the Scottish Health Technologies Group (SHTG) did not reach clear directive conclusions because the evidence base for a technology was weak. Despite being methodologically robust, these products did not meet the needs of decision-makers and may have had negligible impact.

Methods

SHTG set out to equip and empower the recommendation-making council (that is, appraisal committee) to reach clear conclusions. SHTG broadened the HTA components and types of evidence that could be considered. The increased breadth of evidence included: clinicians attending council meetings to respond to questions; patient groups making submissions and presenting at council meetings; Scotland-specific economic modelling; and consultation on draft recommendations. SHTG also restructured the council for improved deliberative decision-making.

Results

Clear directive conclusions were reached in a substantially higher proportion of HTA products (eighty-eight percent in 2019 compared with eight percent in 2017). It became possible for decision-makers to implement findings. It also became feasible to assess the impact and implementation of recommendations.

Conclusions

Broadening SHTG's consideration of HTA components has led to a clearer conclusion being reached and stronger messaging for decision makers. This positions SHTG to increase its influence in the use of health technologies in Scotland.
OP312 Developing A Tool-kit For Assessment Of Autism Spectrum Disorder
Authors: Watson Leah , Jonathan Shirley
Published: December 2021

Introduction

Before the coronavirus pandemic, children who were on the Early Years Neurodevelopment (EYND) assessment pathway and suspected to have possible Autism Spectrum Disorder (ASD), received clinic based appointments. This process included a parental interview by a doctor, a specialist speech and language therapy assessment, autism diagnostic observation schedule (ADOS), which were all carried out on hospital sites. These were postponed in March following national guidance. Our aim was to continue providing accurate evidence-based service for ASD diagnosis.

Methods

We utilised evidence-based telehealth methods to perform a specialist speech and language assessment in a child's home via video call. Parents were also invited to share videos of everyday activities via a secure portal. We could observe the child in a meaningful setting and witness functional impact of their needs. Each case is discussed by a multiagency panel based on DSM-V criteria.

Online training was undertaken by professionals to deliver the Brief Observation of Autism Symptoms (BOSA) based on the ADOS for COVID times. Parents were coached by the therapist to enable them to become the administrator, rather than a professional.

Results

Telephonic feedback from the first ten parents whose children underwent a telehealth assessment has been positive; the home was deemed more natural and for some less distressing than clinic. Formal patient surveys have been devised for both the telehealth and BOSA clinic assessments. Analysis is expected by the end of March.

To date we have been able to reach an outcome for thirty children, the diagnosis of ASD for twenty-four children and the other six received a diagnosis of global developmental delay or language disorder.

Conclusions

We expect that telehealth will reduce the number of assessments before an ASD diagnosis is made resulting in more prudent healthcare. The new methods have demonstrated clear increased parental participation.
OP314 What Happened Next? Assessing Health Technology Assessment Impact In Scotland
Authors: Kandulu Jess
Published: December 2021

Introduction

The Scottish Health Technologies Group (SHTG) set out to assess the impact of HTA products. Two questions were posed: Does advice from SHTG have influence? How is SHTG advice used?

Methods

SHTG adapted a tool developed by the International Network of Agencies for Health Technology Assessment (INAHTA). The INAHTA framework investigates indications of impact and categorizes outputs into levels of impact. Over three years, potential users of SHTG advice were contacted six to twelve months after advice was published and asked how the advice had been used. HTA outputs were categorized into the four levels of influence they achieved: ‘major influence’, ‘some influence’, ‘some consideration’ and ‘no known influence’.

Results

HTA products were found to have been used in four main ways: ‘informed discussion’, ‘referenced’, ‘informed policy’ or ‘directly informed practice’. Levels of influence had steadily increased over the three years assessed. The findings were well received by internal audiences, with particular interest in the various ways HTA recommendations had been used. There was also feedback about ‘marking our own homework’. These results have informed a new SHTG strategy and supported clear messaging around the value of HTA.

Conclusions

SHTG has found a pragmatic, resource-light way to explore the impact of HTA outputs, which has proved valuable for driving strategy and messaging.
OP318 Health Technology Assessment And Decision-Making Processes: The Purchase Of Magnetic Resonance Imaging Technology
Authors: Maia Maria
Published: December 2021

Introduction

Medical devices play an essential role in health care, but they are also a leading causes of increasing healthcare expenditures. The purchase of technologies and the determination of how and when they should be used are among the most important decisions made by decision-makers, at the institutional level.

The present research focuses on the Portuguese health system and sheds light on the characterization of decision-making process by those involved in Magnetic Resonance Imaging (MRI) purchases.

Methods

To characterize the decision-making process, results from forty questionnaires and twenty-seven semi-structured interviews with key decision-makers were merged, using a mixed method approach. To assess competences for decision-making, a questionnaire was applied, and Exploratory and Confirmatory Factorial Analysis conducted.

Results

Cost and suppliers’ characteristics are seen as the most important indicators to guide decisions. The decision is undertaken by a committee, in a bottom-up process, characterized by a bounded rationality, influenced by intuition and a consultant decision-maker. The reasoning and justification for selection of the committee members is unclear. The decision process is considered to be bureaucratic, time-consuming and long. Patients are negatively perceived as stakeholders in the process. Few studies were performed (mostly related to the workload of the Radiology Department) to support the decision and no national or international health technology assessment (HTA) study was used in the process, to guide decisions. Decision-makers have limited knowledge and training in areas of decision-making in the areas of health informatics, health economics and especially HTA. This may limit their ability to truly understand the future implications of their purchase decisions.

Conclusions

To foster HTA in decision-making processes, recommendations are made, in particular, to: (i) establish an HTA in-house unit, able to carry out studies considering the hospital context and aiming to inform managerial local decisions (ii) promote a team comprised of technology assessment multidisciplinary researchers but also professionals from the health institution able to carry out HTA studies (iii) foster common languages and values to increase uptake of HTA studies.
OP338 Involving Patients In Research: Early Consultation Of Women To Improve Study Design And Investigate Trial Acceptability
Authors: Erskine Jamie , Castanon Alejandra
Published: December 2021

Introduction

Gaining the perspective of patients is invaluable in the design, management and reporting of research. As part of the process of facilitating clinical research into the effectiveness of a digital colposcope in a cervical cancer pathway, patients were involved from the outset.

Methods

Using funding made available by a Public Involvement Fund, a patient consultation group was established. The group's initial discussions informed the design of a feasibility study and funding application, which was submitted to the UK National Institute of Health Research (NIHR). A Patient and Public Involvement (PPI) representative was recruited and along with the consultation group, contributed to the ethical approvals for the study. The Patient Information Sheet and Consent Form were reviewed by the patients, to ensure readability, understandability and accessibility. The patient questionnaires and interview topics that are part of the feasibility study were also developed in conjunction with the PPI group, to make sure that women's concerns are being addressed in the research design and protocols.

Results

The PPI consultation group's contributions helped strengthen the funding application and funding for a feasibility study was granted as part of the NIHR's Research for Patient Benefit funding scheme. Part of the grant will be used for training and reimbursement for time spent for the PPI representative. Data collection for the study is due to commence in the summer of 2021. The PPI group will be consulted at the beginning and end of the data collection period and will contribute to the data analysis and dissemination of the research output, including a Plain English Summary.

Conclusions

Involving patients greatly amplified the quality of the funding and ethical applications and will continue to benefit the ongoing research. Resources were widely available within the researcher's University and also through UK-wide schemes. Such resources are crucial and should be encouraged as part of all clinical research.
OP340 Kidney Patients’ Preferences For A Wearable Digital Health Technology To Support Self-Management Of Chronic Kidney Disease - A Discrete Choice Experiment
Authors: Gc Vijay S. , Iglesias Cynthia , Erdem Seda , Hassan Lamiece , Manca Andrea
Published: December 2021

Introduction

Wearable Digital Health Technologies (WDHTs) can support and enhance self-management by giving individuals with chronic conditions more control over their health, safety and wellbeing. Involving patients early on in the design of these technologies facilitates the development of person-centered products. It may increase the potential uptake of (and adherence to) any intervention they are designed to deliver. This research aims to elicit chronic kidney disease (CKD) patients’ preferences for WDHTs that may help patients manage their conditions.

Methods

We used discrete choice experiments (DCE) to elicit preferences for WDHTs characterized by their generalizable characteristics. The study design was informed by a multi-stage mixed-method approach (MSMMA). This included a review of the published literature, focus group interviews and one-to-one interactions with CKD patients to identify relevant characteristics (that is, attributes and levels) associated with wearable DHTs. We collected the data from 113 patients (age ≥18 years) with stage 3 or above CKD. The analysis started with a conventional multinomial logit model and was extended by investigating heterogeneity in preferences via latent class models.

Results

Our MSMMA yielded ten potential attributes for consideration in a choice task. The final list included five attributes, cross-checked and validated by the research team, and patient representatives. The most preferred attributes of WDHTs were device appearance, format and type of information provided, and mode of engagement with patients. Respondents preferred a discreet device, which offered options that individuals could choose from and provided medical information.

Conclusions

We show how to use MSMMA to elicit user preferences in (and to inform the) early stages of the development of WDHTs. Individuals with CKD preferred specific characteristics that would make them more likely to engage with the self-management support WDHT. Our results provide valuable insights that can be used to inform the development of different WDHTs for different segments of the CKD patients population, moving away from a one-size-fits-all provision and resulting in population health gains.
OP345 Evaluation Of An Artificial Intelligence-assisted Service For Cardiac Monitoring As Part Of A National Institute For Health And Care Excellence (NICE) Digital Health Technology Pilot
Authors: Erskine Jamie , Goddard Kate , Chalkidou Anastasia
Published: December 2021

Introduction

Zio XT Service was one of five Digital Health Technologies (DHTs) to be assessed by the National Institute for Health and Care Excellence (NICE) as part of their evaluation pilot. The King's Technology Evaluation Centre (KiTEC) act as an External Assessment Centre for NICE and worked on this pilot evaluation. The service comprises a I-Lead ECG patch, an inbuilt software that makes use of artificial intelligence (AI) algorithms to record, store and analyze ECG traces, and a team of cardiac physiologists.

Methods

Although the methods were based on NICE's existing Medical Technologies Guidance Process, they were modified to suit the assessment of DHTs. The process was split into two sections, with the option to discontinue the assessment if it was considered that insufficient evidence was available for the technology. Clinical experts and patients were consulted through the process and clinical, economic and technical evidence was considered. Costs for three care pathways were modelled.

Results

A total of thirty relevant clinical studies were identified, with a further study being reviewed as part of a separate technical assessment, focusing on the AI component of the technology. Four of the studies were considered to be pivotal to the decision problem, one of which was a Randomized Controlled Trial. The technology was found to have a greater diagnostic yield than a standard ambulatory monitor, however diagnostic accuracy measures were absent in the literature. Three economic models were developed to represent three care pathways: patients with syncope, patients who have had a stroke or transient ischaemic attack and a third model assessing downstream costs associated with stroke treatment.

Conclusions

Digital Health Technologies and Artificial Intelligence Technologies pose novel and unique challenges to health technology assessment (HTA) bodies. Zio XT Service is a diagnostic tool, with both human and AI input, making it a particularly complex technology to assess. This work serves as a case-study in the evaluation of DHTs and AI and the lessons learned may contribute to the development of guidelines for such technologies.
OP437 Use Of Real-World Evidence In Survival Analysis Adjusting For Treatment Crossover In Cutaneous T-Cell Lymphoma
Authors: Hawkins Neil , Evans Rachel , Muszbek Noemi , Jones Trefor , McNamara Linda
Published: December 2021

Real-World Evidence is useful for validating crossover adjustment approaches, particularly when the adjustment is required because a trial does not accurately reflect a health technology assessment (HTA)-relevant population. We use the MAVORIC trial advanced stage mycosis fungoides and Sézary syndrome cutaneous T-cell lymphoma population and data from the Hospital Episodes Statistics to explore and validate crossover adjustment methods.

Introduction

The MAVORIC trial compared mogamulizumab to vorinostat in patients with mycosis fungoides (MF) or Sézary syndrome (SS), subtypes of cutaneous T-cell lymphoma. However, the treatment comparison within MAVORIC may not represent an HTA relevant population from a UK perspective: (i) 72.6 percent of patients randomized to vorinostat switched to mogamulizumab and (ii) vorinostat is not used in current clinical practice in the UK. This study explores methods to adjust treatment effect estimates using different crossover adjustment methods and Real-World Evidence.

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. See www.mhra.gov.uk/yellowcard for how to report side effects.

Methods

An advanced stage (stage ≥IIB MF and all SS) population was included. Three methods were considered for treatment crossover adjustment. A synthetic control arm was created using the Hospital Episodes Statistics (HES) dataset. Predicted survival for the MAVORIC control arm, post-crossover adjustment, was compared to the HES to inform the selection of the appropriate methods for adjustment. A direct comparison between mogamulizumab (reweighted to represent the distribution of MF/SS patients in the HES) and the synthetic control was also conducted.

Results

Following crossover adjustment of the vorinostat arm, using the inverse probability of censoring weighting method, the overall survival (OS) hazard ratio (HR) estimate for mogamulizumab vs. vorinostat was 0.45 (95% confidence interval (CI): 0.19, 1.07). This adjustment method was considered the most appropriate based on an assessment of assumptions and a comparison of OS between the adjusted vorinostat data and the HES data. The OS HR estimate for reweighted mogamulizumab vs. synthetic control from HES was 0.33 (CI: 0.21, 0.50).

Conclusions

Real World Evidence from the HES database can be used to validate crossover adjustment methods and to better reflect current clinical practice in the UK. Results using both methods support each other.
PP89 The Investigation And Development Of A National Formulary Monitoring System Across Wales
Authors: Boldero Richard , Curran Thomas , Haines Kath , Morton Miranda , Routledge Phil A.
Published: December 2021

Introduction

The New Treatment Fund (NTF), launched in January 2017, aims to support the faster introduction of new medicines recommended by the National Institute for Health and Care Excellence (NICE) and the All Wales Medicines Strategy Group (AWMSG). The NTF requires seven health boards and one trust to make recommended medicines available within 60 days of any positive recommendation decision. The project goal was to develop a system for demonstrating how monitoring the NTF improves medicines access for the people of Wales.

Methods

The process was derived via a series of task and finish group meetings with relevant stakeholders. The monitoring criteria were agreed through a collaborative expert approach using a nominal group technique. This determined a minimal dataset of formulary status, which included time to formulary addition. Pre-NTF medicines data (n = 59) were available for a six-month period.

Results

By the three-year milestone of the NTF, the average time taken for newly recommended medicines (n = 219) to become available to patients across Wales had decreased by eighty-five percent from 90 to 13 days (p < 0.01).

Conclusions

An innovative and robust system has been created for accurately monitoring the formulary addition of medicines within the NTF, supporting the rapid and comprehensive uptake of medicines deemed clinically and cost effective by NICE and the AWMSG.
PP94 Pandemic Preparedness: EUnetHTA COVID-19 Rapid Response With “Rolling Collaborative Reviews (RCR)”
Authors: Wild Claudia , Mayer-Ferbas Julia , Willemsen Anne
Published: December 2021

Introduction

Potential therapies and interventions for COVID-19 are emerging and developing rapidly. In a response to this public health emergency, the European Network for Health Technology Assessment (EUnetHTA) aims to support health policy in preparation for evidence-based purchasing. To monitor the emerging evidence, a new EUnetHTA product was created: Rolling Collaborative Reviews (RCRs).

Methods

RCRs are living documents that are descriptive in nature, updated monthly, and centrally coordinated. They are based on the following three sources of information: (i) published randomized controlled trials (RCTs) presented as a summary of efficacy and safety data (synthesized for a network meta-analysis conducted by the Department of Epidemiology Lazio Regional Health Service, Italy); (ii) published prospective observational studies for safety results, provided by the Map of COVID-19 Evidence conducted by the Norwegian Institute of Public Health, Norway; and (iii) RCTs registered in clinical trial registries (ClinicalTrials.gov, EudraCT Register, and the ISRCTN registry). Additionally, detailed stopping and starting rules were defined.

Results

As of November 2020, 14 RCRs were ongoing. From the initial list of RCRs, one was suspended due to lacking effectiveness and two moved on to rapid collaborative reviews due to European Medicines Agency approvals. Four RCRs are updated on a bimonthly basis due to a lack of high-quality evidence, and five new RCRs will be started because of promising clinical studies.

Conclusions

RCRs can be a means of providing timely and continuous policy support, but they require a high level of coordinated effort.
PP106 Twenty Years Of Orphan Medicines Regulation: Have Treatments Reached Patients In Need Across Europe And Canada?
Authors: Henderson Nadine , O'Neill Phill , Garau Martina
Published: December 2021

Introduction

The European Union regulation for orphan medicinal products (OMPs) was introduced to improve the quality of treatments for patients with rare conditions. To mark 20 years of European Union OMP regulation, this study compared access to OMPs and the length of their reimbursement process in a set of European countries and Canadian provinces. Access refers to their full or partial reimbursement by the public health service.

Methods

Data were collated on European Medicines Agency orphan designation and marketing authorizations, health technology assessment (HTA) decisions and reimbursement decisions, and the respective dates of these events for all the OMPs centrally authorized in 14 European countries (Belgium, England, France, Germany, Hungary, Italy, the Netherlands, Norway, Poland, Scotland, Slovakia, Spain, Sweden, and Switzerland) and four Canadian provinces (Alberta, British Columbia, Ontario, and Quebec).

Results

Since the implementation of the OMPs Regulation in 2000, 215 OMPs obtained marketing authorization. We found that Germany had the highest level of coverage, with 91 percent of OMPs being reimbursed. The three countries with the lowest reimbursement rates were Poland, Hungary, and Norway (below 30%). We observed that Germany had the quickest time to reimbursement following marketing authorization, followed by Switzerland and Scotland. We observed that Poland, Hungary, and Slovakia consistently had the longest time to reimbursement.

Conclusions

We observed substantial variation in the levels and speed of national reimbursement of OMPs, particularly when comparing countries in Eastern and Western Europe, which suggests that an equity gap between the regions may be present. The data also indicated a trend toward faster times to reimbursement over the past 10 years.
PP145 VALIDATE Methodology For A Medication-Related Clinical Decision Support System: Innovating Or Going Back To Basics?
Authors: Fernandez-Barceló Carla , Calvo-Cidoncha Elena , Sampietro-Colom Laura
Published: December 2021

Introduction

In the past decade, health technology assessment (HTA) has narrowed its scope to the analysis of mainly clinical and economic benefits. However, twenty-first century technology challenges require the need for more holistic assessments to obtain accurate recommendations for decision-making, as it was in HTA's foundations. VALues In Doing Assessments of health TEchnologies (VALIDATE) methodology approaches complex technologies holistically to provide a deeper understanding of the problem through analysis of the heterogeneity of stakeholders’ views, allowing for more comprehensive HTAs. This study aimed to assess a pharmaceutical clinical decision support system (CDSS) using VALIDATE.

Methods

A systematic review of the empirical evidence on CDSS was conducted according to PRISMA guidelines. PubMed, the Cochrane Library, and Web of Science databases were searched for literature published between 2000 and 2020. Additionally, a review of grey literature and semi-structured interviews with different hospital stakeholders (pharmacists, physicians, computer engineers, etc.) were conducted. Content analysis was used for data integration.

Results

Preliminary literature results indicated consensus regarding the effectiveness of CDSS. Nevertheless, when including multistakeholder views, CDSS appeared to not be fully accepted in clinical practice. The main reasons for this appeared to be alert fatigue and disruption of workflow. Preliminary results based on information from the literature were contrasted with stakeholder interview responses.

Conclusions

Incorporation of facts and stakeholder values into the problem definition and scoping for a health technology is essential to properly conduct HTAs. The lack of an inclusive multistakeholder scoping can lead to inaccurate information, and in this particular case to suboptimal CDSS implementation concerning decision-making for the technology being evaluated.
PP148 Liquid Biopsy For The Detection Of Ovarian Or Endometrial Cancer In Samples Taken From The Pap Smear: PapSEEK
Authors: García Vanesa Ramos , Perestelo-Pérez Lilisbeth , Rivero-Santana Amado , Duare-Díaz Andrea , Álvarez-Pérez Yolanda , Torres-Castaño Alezandra , Toledo-Chávarri Ana , Serrano-Aguilar Pedro
Published: December 2021

Introduction

The PapSEEK test is an emerging minimally invasive technique in which samples are collected from the endocervical or intrauterine cavity with the Papanicolaou (Pap) brush or the Tao brush to detect somatic mutations or aneuploidies indicating the presence of endometrial or ovarian cancer.

Methods

We systematically searched for articles published up to October 2020 in the following electronic databases: Medline, Embase, the Cochrane Library, and the Centre for Reviews and Dissemination. We included experimental studies, observational primary studies, and cost-effectiveness studies evaluating the safety, effectiveness, and cost effectiveness of the PapSEEK test for the early detection of ovarian or endometrial cancer. Relevant outcomes included sensitivity, specificity, the coefficient of variation, re-test rates, the incremental cost-effectiveness ratio, the incremental cost-utility ratio, and the cost of each alternative.

Results

A single relevant retrospective study was identified. In this study, samples from women with endometrial cancer (n = 656) and ovarian cancer (n = 254) were collected with the Pap brush and Tao brush and compared with samples from healthy women (n = 1,002). The diagnostic validity for somatic mutation or aneuploidies obtained with a Pap brush had a sensitivity of 81% for endometrial cancer and 33% for ovarian cancer, and a specificity of 99% for both conditions. When samples were collected from the intrauterine cavity with a Tao brush, the sensitivity increased to 93% for endometrial cancer and to 45% for ovarian cancer. The sensitivity of the PapSEEK test increased only for ovarian cancer when plasma samples to detect circulating tumor DNA were collected in addition to Pap smear samples. This strategy provided a diagnostic validity of 43%, which was higher in late-stage ovarian cancer (56% versus 35%), and a specificity of 100%.

Conclusions

Prospectively designed studies are required to assess the safety and effectiveness of the PapSEEK test in screening settings, as well as studies comparing the technology with conventional screening methods. No cost-effectiveness studies have been conducted for the PapSEEK test.
PP162 Use Of The RenalGuard® System To Prevent Contrast-Induced Nephropathy
Authors: Bektassova Perizat , Benberin Valeriy , Avdeyev Andrey , Shanazarov Nasrulla , Akhmedullin Ruslan , Okesh Makhabbat , Aimanova Tansholpan , Bariyeva Gulzada
Published: December 2021

Introduction

Contrast-induced nephropathy (CIN) is a common cause of hospital-acquired acute kidney injury (AKI) following the administration of contrast media for coronary interventions or procedures such as diagnostic coronary angiography. The optimal way of preventing CIN remains uncertain. However, preliminary intravenous hydration, minimizing the volume of contrast media, and avoiding the use of nephrotoxic drugs are recommended in current management guidelines. The aim of this analysis was to compare the RenalGuard® system with standard care.

Methods

A comprehensive literature search was conducted in PubMed and Google Scholar to identify evidence on the clinical and economic effectiveness of forced diuresis with matched hydration using the RenalGuard system for preventing CIN. Multiple criteria decision analysis (MCDA) was used to assess the performance of the method in hospital settings, compared with alternative options.

Results

Several systematic reviews with meta-analyses demonstrated that forced diuresis with matched hydration using the RenalGuard system was associated with a significantly lower relative risk of CIN among high-risk patients with chronic kidney disease. However, the evidence supporting the advantage of the proposed method over current forced diuresis techniques with manual calculation of the volumes for matched hydration in the hospital setting was limited.

Conclusions

Although the effectiveness of the RenalGuard system has been demonstrated in meta-analyses, its clinical advantage over forced diuresis with manual hydration calculation is uncertain. It is also worth noting the lack of evidence to date on this technology, the fact that it is still at the research stage in some countries, and that it is not included in CIN management guidelines.
PP216 Indirect Treatment Comparison Assessment: An Improvement Intervention In The Scottish Medicines Consortium
Authors: Scott John , McMurray Moira , O'Connell Rickie , McGuire Pauline , Downes Noreen
Published: December 2021

Introduction

The Scottish Medicines Consortium (SMC) conducts early health technology assessment (HTA) of new medicines on behalf of the National Health Service Scotland based on pharmaceutical company submissions. As the appraisals are conducted close to the point of marketing authorization, there is often a lack of direct head-to-head data. In 2019, assessment of relevant comparative efficacy was informed via indirect treatment comparisons (ITC) in 55 percent (36/66) of submissions. While the ITCs are essential to the decision-making process, they are frequently incomplete.

Methods

A focus group was conducted with the clinical assessment team (n = 11) to explore problems in the submission process and to identify areas for improvement. It was agreed that providing improved guidance to companies prior to submission may prevent future inconsistencies. A working group (n = 5) was tasked with identifying and implementing potential solutions. The group reviewed the focus group findings, relevant literature, and guidance from other organizations. Draft guidance was developed that was reviewed by two pharmaceutical industry representatives (SMC subcommittee members).

Results

Findings from the focus group highlighted issues broadly related to the incomplete presentation and reporting of ITCs. The improved guidance document outlined specific requirements in a checklist format for reporting and presenting the results of different ITC data. This guidance was published in February 2020. To evaluate the impact of the updated guidance and to identify any further changes required, a follow-up focus group and survey of industry representatives is planned for March 2021.

Conclusions

The aim of the ITC guidance is to provide pharmaceutical companies with direction to improve the quality and transparency of reporting, which will in turn improve the quality of HTAs and thus strengthen the recommendations provided by the SMC. The follow-up focus groups and survey will assess the impact of the guidance. It is acknowledged that the results of this process may be limited by the small sample size and short duration of the assessment.
PP222 Efficacy And Safety Of Foot Reflexology
Authors: del Mar Trujillo-Martín Mª , Pino.Sedeño Tasmania Del , Leon-salas Beatriz , García Javier García , Brito Néstor Benitez , Gonzalez Asunción Gaitán , Rodríguez Leticia Rodríguez , de Alba Inmaculada Guerrero Fernández , Aguilar Pedro Serrano
Published: December 2021

Introduction

Foot reflexology is a type of complementary manual therapy that consists of applying pressure or massage to the sole of the foot to produce various therapeutic effects in other body areas or organs. This technique has been used in many different clinical indications, but there is uncertainty about its real effect. A health technology assessment (HTA) was conducted to analyze the efficacy and safety of foot reflexology within the framework of the “Health Protection Plan Against Pseudo-Therapies,” which was established in 2018 by the Spanish Ministry of Health and the Ministry of Science and Innovation.

Methods

A systematic review and metanalysis was conducted to synthesize the available scientific literature on the efficacy and safety of foot reflexology in people of any age with any disease or medical condition.

Results

Sixty-eight randomized controlled studies were included. Pooled estimates indicated that foot reflexology had no effect on pain, fatigue, depression, quality of life, quality of sleep, or blood pressure, compared with non-reflexological foot massage. Improvements in pain (standardized mean difference [SMD] −1.11, 95% CI: −1.70 - −0.52), fatigue (SMD −0.93, 95% CI: −1.36 - −0.51), sleep quality (SMD −1.11, 95% CI: −1.68 - −0.34), and systolic (mean difference [MD] −7.36, 95% CI: −8.49 - −6.23) and diastolic (MD −5.07, 95% CI: −0.98 - −0.22) blood pressure were obtained when reflexology was compared with usual care or no intervention. In the case of anxiety levels, the benefit obtained with foot reflexology compared with any comparator (SMD −0.6, 95% CI: −0.98 - −0.22) was attenuated when compared with non-reflexological foot massage (SMD −0.2, 95% CI: −0.36 - −0.03). Very few studies reported on the safety of foot reflexology.

Conclusions

There was no evidence for any specific effect of reflexology for any condition when compared with non-reflexological foot massage, except for a positive effect on anxiety levels.
PP230 Safety, Effectiveness, And Cost Effectiveness Of Interventions For Preventing Delirium In Hospitalized Patients
Authors: León-Salas Beatriz , Linertová Renata , García-García Javier , Pérez-Ros Pilar , Rivas-Ruiz Francisco , Toledo-Chávarri Ana , Trujillo-Martín María M.
Published: December 2021

Introduction

Delirium is a prevalent syndrome in the hospital setting and the elderly are the most affected. The objective was to assess the safety, clinical effectiveness, and cost effectiveness of interventions for preventing delirium among people aged 65 years or older at hospital admission.

Methods

A systematic review of available scientific literature (randomized controlled trials) on the safety, effectiveness, and cost effectiveness of the interventions was conducted. The overall effect size for each type of intervention was estimated through a meta-analysis. A cost-effectiveness study in the context of the Spanish National Healthcare System was performed.

Results

Forty-nine studies were included for the effectiveness and safety assessment (25 on pharmacological interventions, 12 on perioperative interventions, 2 on non-pharmacological interventions, and 10 on multicomponent interventions). The following interventions reduced delirium incidence relative to usual care or placebo: hypnotics and sedatives (13 studies; risk ratio [RR] 0.54: 95% confidence interval [CI] 0.36–0.80); perioperative interventions aimed at limiting opioid use (two studies; RR 0.50, 95% CI: 0.29–0.86); controlling the intensity of general anesthesia (three studies; RR 0.77, 95% CI: 0.59–0.99); and multicomponent interventions (10 studies; RR 0.62, 95% CI: 0.54–0.72). In addition, multicomponent interventions reduced the duration (mean difference −1.18, 95% CI: −1.95 - −0.40) and severity of delirium (standardized mean difference −0.98, 95% CI: −1.46 - −0.49), while dexmedetomidine reduced the duration of delirium (mean difference −0.70, 95% CI: −1.03 - −0.37).

The economic analysis of a multicomponent preventive intervention estimated an average cost of EUR7,282 per patient, which was EUR140 per patient more expensive than usual care. The incremental cost-effectiveness ratio was EUR21,391 per quality-adjusted life-year, which is below the acceptability threshold used in Spain. The literature review yielded two economic evaluations that estimated the cost effectiveness of a multicomponent intervention in the United Kingdom and found that the multicomponent intervention was a dominant strategy.

Conclusions

This meta-analysis suggests that multicomponent interventions and dexmedetomidine are effective in reducing the incidence of delirium in hospitalized patients and that multicomponent interventions could be a cost-effective strategy in Spain.
PP231 Safety, Effectiveness And Economic Analysis Of Exercise Intervention For Prevention Of Cognitive And Functional Deterioration In Hospitalized Patients
Authors: León-Salas Beatriz , Linertová Renata , García-García Javier , Pérez-Ros Pilar , Rivas-Ruiz Francisco , Toledo-Chávarri Ana , Trujillo-Martín María M.
Published: December 2021

Introduction

Cognitive and functional deterioration is common in hospital setting and occurs in 40 percent of admitted older patients. One of its main causes is physical inactivity. The objective of our health technology assessment was to assess the safety and clinical effectiveness of a structured multicomponent intervention of physical exercise (Vivifrail) for the prevention of the cognitive and functional deterioration in hospitalized patients aged 70 years or older and to estimate costs and the budgetary impact for the Spanish National Health Service.

Methods

A systematic review of available scientific literature (including experimental and observational designs) on the safety and effectiveness of Vivifrail was performed. A costing study and budgetary impact analysis of the incorporation of Vivifrail as a therapeutic alternative to standard care with a time horizon of 5 years was performed.

Results

One randomized controlled trial (RCT) (n = 370) showed positive effects of Vivifrail compared to usual care in functional capacity (mean difference (MD) = 2.20, 95% confidence interval (CI) 1.78 to 2.62), cognitive state (MD = 1.80, 95% CI 1.24 to 2.36), and quality of life (MD = 13.20, 95% CI 12.70 to 13.70). Regarding other variables, the Vivifrail increased the grip strength of the dominant hand (MD = 2.30; 95% CI = 1.79 to 2.81), verbal fluency (MD = 2.15; 95% CI = 1.56 to 2.74), performance of double tasks (MD = 0.10; 95% CI = 0.07 to 0.13), executive function (MD = −31.07; 95% CI = −49.23 to −12.91) and emotional state (MD = −2.00; 95% CI = −2.50 to −1.50).

The total cost of implementing Vivifrail in a 1,000-bed general hospital would be EUR18,000 per year (adjusted to 2020 currency), with approximately 150 patients older than 75 years benefited. This represents a cost of EUR120 per patient.

Conclusions

The Vivifrail could improve functional and cognitive capacity, although available evidence on the Vivifrail is very scarce. More well designed and executed RCT and cost-effectiveness study confirming or refuting the promising findings are needed for a new assessment.
PP254 Double-Counting In Evidence Synthesis Including Routinely Collected Data: Methodological and Practical Considerations
Authors: Hussein Humaira , Nevill Clareece , Meffen Anna , Bujkiewicz Sylwia , Sheehan Nuala , Sutton Alex , Abrams Keith , Gray Laura
Published: December 2021

Introduction

The use of real-world data, as an alternative to randomized controlled trials, is becoming increasingly common in the evaluation of new health technologies. With this rise in real-world literature, such data will also enter evidence synthesis models. While it can be beneficial to utilize data from all available sources, this can introduce the problem of double-counting of participants.

Methods

Using a number of case-studies, we discuss and illustrate various issues around double-counting. These include synthesis of studies using the same database or the same subset of participants, overlapping use of intervention arms across studies and the use of registry data from the participants overlapping with those in randomized controlled trials. The implications in research are considered along with common methods used currently to overcome these issues.

Results

Double-counting of participants in evidence synthesis can artificially inflate precision, potentially leading to inappropriate conclusions. Common methods currently used to help mitigate the impact of double-counting includes stratifying analysis to different timelines, using the most comprehensive study in the evidence synthesis model or using the study that has the largest sample size. However, in all of these cases, sensitivity analyses would need to be considered to ensure robust results.

Conclusions

Currently, there are no published guidelines on how to address the issue of double-counting. With the increased use of real-world data in evidence synthesis, double-counting has the potential to become a significant issue. Therefore, it is of significant importance that methodologies and guidelines are developed to address this.
PP290 Ongoing Swedish Initiatives To Improve The Potential For Real World Data Assessment Of Medical Devices
Authors: Hedblom Amanda Hansson , Saunders Rhodri
Published: December 2021

Introduction

In 2020, the Swedish regions cemented a national managed-introduction project for medical devices, to ensure equal, cost-effective, and appropriate use. Health technology assessment (HTA) is an important component of the project. Swedish national health registers have world-class coverage and completeness but may lack information enabling adequate evaluation of medical devices. This study reviews the current situation and ongoing initiatives. Additionally, the potential for medical device health economics and outcomes research (HEOR) using Swedish registers is assessed.

Methods

A review of Swedish national health registers was undertaken, focusing on available data, and contextualized for the purpose of HEOR for medical devices. Additionally, the review included an evaluation of the Swedish reimbursement authority's (The Dental and Pharmaceutical Benefits Agency, TLV) ongoing initiatives to improve the potential to follow-up the impact of the technologies they assess and develop value-based pricing schemes.

Results

Five registers were deemed the most relevant national health registers for device research. They include high-quality longitudinal data and are linkable on a per-patient basis. For devices, main limitations include limited data on specialized outpatient care, lags in updating certain registers, lack of laboratory data, and challenges in identifying the specific device used. Reports indicate that certain limitations are being addressed, including pilot-studies investigating the opportunity for automated reporting of data from regional systems, and app-collected patient-reported health data.

Conclusions

Swedish registers provide comprehensive sources for HEOR studies, but limitations related to the assessment of medical device impact remain. As is common with register data reporting grouped diagnoses and interventions, specific devices are not directly identifiable in the national health registers. For some devices, this might be addressable through linkage with other data-sources. Swedish authorities are undertaking several initiatives that will likely improve the potential for HTA and follow-up of medical devices using national health register data.
PP296 Patient Involvement In An Assessment Of The Management Of Sudden Onset Severe Headache Presenting To The Emergency Department
Authors: Wade Ros , Walton Matthew , Harden Melissa , Hodgson Robert , Eastwood Alison , Storey James , Hassan Taj , Randall Marc , Hassan Abu , Williams John
Published: December 2021

Introduction

Sudden onset severe headache is usually caused by a primary headache disorder but may be secondary to a more serious problem, such as subarachnoid hemorrhage (SAH). Very few patients who present to hospital with headache have suffered a SAH, but early identification is important to improve patient outcomes. A systematic review was undertaken to assess the clinical effectiveness of different care pathways for the management of headache, suspicious for SAH, in the Emergency Department. Capturing the perspective of patients was an important part of the research.

Methods

The project team included a patient collaborator with experience of presenting to the Emergency Department with sudden onset severe headache. Three additional patients were recruited to our advisory group. The patient's perspective was collected at various points through the project including at team meetings, during protocol development and when interpreting the results of the systematic review and drawing conclusions.

Results

Patients were reassured by the very high diagnostic accuracy of computed tomography (CT) for detecting SAH. Patients and clinicians emphasized the importance of shared decision making about whether to undergo additional tests to rule out SAH, after a negative CT result. When lumbar puncture was necessary, patients expressed a preference to have it on an ambulatory basis; further research on the safety and acceptability of ambulatory lumbar puncture was recommended.

Conclusions

Patient input at the protocol development stage helped researchers understand the patient experience and highlighted important outcomes for assessment. Patient involvement added context to the review findings and highlighted the preferences of patients regarding the management of headache.