bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP72 Software Tools For Systematic Literature Review In Medicine: A Review And Feature Analysis
Authors: Kallmes Kevin , Cowie Kathryn , Hardy Nicole , Holub Karl 
Published: December 2022

IntroductionSystematic reviews (SRs) are central to evaluating therapies but have high costs in time and money. Many software tools exist to assist with SRs, but most tools do not support the full process, and transparency and replicability of SR depends on performing and presenting evidence according to established best practices. In order to provide a basis for comparing between software tools that support SR, we performed a feature-by-feature comparison of SR tools.MethodsWe searched for SR tools by reviewing any such tool listed the Systematic Review Toolbox, previous reviews of SR tools, and qualitative Google searching. We included all SR tools that were currently functional, and required no coding and excluded reference managers, desktop applications, and statistical software. The list of features to assess was populated by combining all features assessed in four previous reviews of SR tools; we also added five features (manual addition, screening automation, dual extraction, living review, and public outputs) that were independently noted as best practices or enhancements of transparency/replicability. Then, two reviewers assigned binary ‘present/absent’ assessments to all SR tools with respect to all features, and a third reviewer adjudicated all disagreements.ResultsOf 53 SR tools found, 29 were excluded, leaving 24 for assessment. Thirty features were assessed across six classes, and the inter-observer agreement was 86 percent. DistillerSR (Evidence Partners; n = 26/30, 87%), Nested Knowledge (Nested Knowledge; n = 25/30, 83%), and EPPI-Reviewer Web (EPPI-Centre; n = 24/30, 80%) support the most features followed by Giotto Compliance (Giotto Compliance; n = 23/30, 77%), LitStream (ICF; n = 22/30, 73%), and SRDB.PRO (VTS Software; n = 21/30, 70%). Seven tools support fewer than half of all features assessed: RobotAnalyst, SyRF, Data Abstraction Assistant, SWIFT-Review, SR-Accelerator, RobotReviewer, and COVID-NMA. Notably, only 10 tools (42%) support direct search, 7 (29%) offer dual extraction, and 13 (54%) offer living/updatable reviews.ConclusionsDistillerSR, EPPI-Reviewer Web, and Nested Knowledge each offer a high density of SR-focused web-based tools. By transparent comparison and discussion regarding SR tool functionality, the medical community can choose among existing software offerings and note the areas of growth needed, most notably in the support of living reviews.
OP73 Tools That Can Aid Adaptive HTA To Ensure Rapid, Efficient, And Pragmatic Priority Setting: A Scoping Review
Authors: Heupink Lieke Fleur , Peacocke Elizabeth , Sæterdal Ingvil , Chola Lumbwe , Frønsdal Katrine 
Published: December 2022

IntroductionProducing new health technology assessments (HTA) can be a time-consuming process. With finite resources in HTA agencies, limited capacities in countries without formalized HTA processes, and growing interest for lifecycles approaches valuing health technologies; innovative and efficient HTA processes are needed. “Adaptive HTA”, referring to the pragmatic use of HTA methods and existing (HTA) evidence, might offer solutions. We will present the results from a scoping review that mapped existing tools, methods, practices to transfer existing HTAs; and reflect on these findings given our own experiences of adaptation processes in LMICs.MethodsWe undertook a scoping review and systematically searched five electronic databases. Inclusion of articles followed strict in- and exclusion criteria. Data extraction focused on information regarding tools, methods, and practices that could aid the transferability of HTA analysis. Here, HTAs referred to full-HTAs and other HTA products, as partial HTAs, economic evaluations, or systematic reviews. Lastly, we mapped the possible overarching factors that can affect transferability.ResultsThe search (November 2020) identified 2030 hits, of which 19 were included. Most HTA transfers followed five steps that closely resemble a de novo HTA process. The identified transferability tools, often checklists, were merely aids or a “catalyst” for the transfer and provided limited guidance for the whole transfer process. Contrastingly, we identified three frameworks that can support the whole process: European Network for HTA (EUnetHTA) Adaptation Toolkit, TRANSFER framework for systematic reviews, and paper series on systematic reviews for economic evaluations. Lastly, our findings pointed to various challenges and knowledge gaps; especially for transfers in low and middle income countries evidence is limited.ConclusionsThe re-use of existing evidence in HTA reports is not new; and readily part of de novo and adaptive processes. The innovative nature of adaptive HTA comes from its ability to unpack the process of adaptation and transferability. Simultaneously, this scoping review highlighted gaps in existing adaptive methods, and could aid future adaptive HTA process for experienced and new HTA-doers.
OP79 Incorporating Environmental Impacts Into Health Technology Assessment: An Examination Of Potential Approaches And Challenges
Authors: Kenny Juliet , Shah Koonal , Toolan Michael , Crabb Nick , Greaves Felix , Jónsson Páll , Richardson Judith , Walpole Sarah 
Published: December 2022

IntroductionIn light of government and healthcare system commitments to reducing the carbon footprint of healthcare, health technology assessment (HTA) agencies are increasingly motivated to investigate how to consider environmental sustainability in their assessments and guidance. This constitutes a major departure from the existing remits and objectives of most agencies, which typically focus on improving population health outcomes. This presentation seeks to identify options for incorporating environmental impact data into HTA and to examine the main challenges, focusing on the National Institute for Health and Care Excellence (NICE) as a case study.MethodsWe present four broad approaches that could be pursued, informed by policy analysis undertaken by NICE. The strengths, weaknesses and implications of each approach are assessed.ResultsThe first option is to act as an ‘information conduit’, aggregating and distributing in a standardized format environmental impact information that is provided voluntarily by health technology manufacturers. The second is to present complementary analyses of environmental impact data, separately but alongside results from established health economic analyses (‘parallel evaluation’ model). The third is to incorporate environmental impact data into health economic analyses, for example by monetizing environmental outcomes, so that quantitative estimates of treatment value are directly affected by environmental benefits and costs (‘integrated evaluation’ model). The fourth is to create new decision-making frameworks for evaluating healthcare interventions that are not expected to improve health-related outcomes, but claim to have relative environmental benefits.ConclusionsWe conclude that these approaches are not mutually exclusive, and all involve some degree of benefit and risk. We explain why the parallel evaluation model may be the most appropriate approach for NICE as a first response to the increased demand for guidance on the environmental impact of health technologies. We also outline activities being undertaken by NICE and other agencies such as the Canadian Agency for Drugs and Technologies in Health to develop new methodologies for incorporating environmental impact data into their HTAs.
OP86 Chatbot-Based Symptom-Checkers: A Systematic Review
Authors: Jeindl Reinhard , Goetz Gregor 
Published: December 2022

IntroductionSymptom-checkers are digital health applications (DHA) with diagnostic algorithms. These symptom-checkers claim to improve the diagnostic process and patient guidance. After asking the user to describe the symptoms using a chatbot interface, the symptom-checkers offer a list of potential diagnoses, and/or give recommendations for appropriate action (self-care, doctor’s visit, or emergency care). Because of the growing number and increasing use of these diagnostic DHA, there is a need to evaluate the evidence.MethodsWe updated a British evidence synthesis on symptom-checkers from the National Institute for Health Research (NIHR, 2019). For the systematic update search, we selected four databases. The following endpoints were selected: effectiveness, safety, diagnostic accuracy, triage accuracy, organizational and patient-relevant endpoints. For accuracy studies included from the update search, we assessed the risk of bias (RoB) using the quality assessment tool of diagnostic accuracy studies (QUADAS-2).ResultsThe NIHR-report included 27 studies. We added 14 additional studies via update search. One randomized-controlled-trial (RCT) reported a prolonged illness duration when using symptom-checkers (statistically non-significant). No harms when using symptom-checkers were identified (six observational studies). The diagnostic accuracy ranged from 14-84.3 percent (ten observational studies), the triage accuracy ranged from 33-100 percent (eleven observational studies). For organizational endpoints, the results were inconsistent (one RCT, six observational studies). The patient perspective indicates a high usability for symptom-checkers, but the limited description of symptoms and the missing verbal interaction with health personnel were mentioned as hindering factors (nine survey-studies). The QUADAS-2 assessment for RoB was low in one, and high in seven studies.ConclusionsThe studies were often conducted using fictitious case-vignettes, limiting the validity of the evidence. Therefore, the results for the diagnostic and triage accuracy are insufficient to demonstrate a benefit in real-world settings. Additionally, there is a concern for misdiagnosis and overdiagnosis. We recommend a continuous monitoring of these diagnostic DHA, using high-quality studies.
OP91 The Current State Of Disease-Specific Registries For The Monitoring Of Expensive Pharmaceuticals In The Netherlands
Authors: Goettsch Wim , Timmers Lonneke , Lobbezoo Dorien , Hagen Marielle 
Published: December 2022

IntroductionOn a regular basis, new and innovative medicines come to the market; with uncertainties surrounding their exact effect in patients. To address these uncertainties, disease-specific registries are commonly being used. The Dutch National Health Care Institute (Zorginstituut Netherland [ZIN]) started, in collaboration with stakeholders, a national program on the management and coordination of disease-specific registries. The main goal is to improve the quality and consistency of these registries and thereby increase the value of the data in monitoring innovative, expensive medicines. As a starting point for this program, we performed a study on the current state of these registries in the Netherlands.MethodsUsing an initial list of 114 registries, we sent out questionnaires to 58 disease-specific registries that collected information on medicine use. Thirty registries responded and their registries were used for the analysis.ResultsOf 30 registries that responded, 15 registries collect information on orphan medicinal products. Most registries are in the field of internal medicine (n = 8), oncology (n = 6), and rheumatology (n = 5). The size of the registries ranged between 250 patients (orphan diseases) and more than 10,000 patients (oncology). Only 13 registries collect information on patient reported outcomes. Data collection is mostly performed manually and standard coding systems such as Systemized Nomenclature of Medicine (SNOMED), Logical Observation Identifiers, Names, and Codes (LOINC), and The International Classification of Diseases 10th Revision (ICD-10) are not routinely used. Finally, our results show that most registries are (partly) dependent on the funding of pharmaceutical companies.ConclusionsOur assessment shows variation in the type, goal of, governance, and funding of the disease-specific registries investigated. We believe that these results show the importance of further national coordination of the disease-specific registries to increase the usability of their data to address the uncertainties surrounding these innovative, expensive medicines.
OP93 Informing Efficient Diagnostic Monitoring Pathways Using Prospective Cohort Data: A Case Study In Neovascular Age-Related Macular Degeneration
Authors: Scotland Graham , Hernández Rodolfo , Kennedy Charlotte , Banister Katie , Goulao Beatriz , Cook Jonathan , Sivaprasad Sobha , Hogg Ruth , Azuara-Blanco Augusto , Heimann Heinrich , Dimitrova Maria , Gale Richard , Porteous Mia , Ramsay Craig , Chakravarthy Usha 
Published: December 2022

IntroductionSeveral diagnostic tests are often adopted into diagnostic pathways for specific indications without strong evidence to support their use. In this context, real-world prospective cohort studies in combination with decision modelling can generate evidence to support decision-making. The Early Detection of neovascular Age-Related Macular Degeneration (EDNA) study was a prospective cohort designed to assess the diagnostic accuracy and cost-effectiveness of several diagnostic monitoring tests used in routine practice for the detection of neovascular age-related macular degeneration (nAMD) in the second eye of patients being treated for unilateral disease.MethodsFive-hundred and fifty-two participants with newly diagnosed unilateral nAMD were monitored for up to 3 years in 24 UK eye clinics. The diagnostic monitoring performance of five index tests was compared: self-reported change in visual function, Amsler test, clinic measured change in visual acuity, fundus assessment by clinical examination or colour photography, and spectral-domain optical coherence tomography (SD-OCT). The reference standard was fundus fluorescein angiography (FFA). A patient-level state transition model was used to simulate the onset of nAMD in the second eye, and assess the impact of different tests on the timing of detection and treatment, and associated costs and quality adjusted life years (QALYs) over a 25-year time-horizon.ResultsOne hundred and forty-five (26.3%) patients developed active nAMD in the study eye, of whom 120 had an FFA at detection. SD-OCT had the highest sensitivity (91.7 percent (95% CI: 85.2-95.6) and provided high specificity (87.8% (95% CI: 83.8-90.9)). It generated more QALYs and lower health and personal social care costs compared to all other monitoring tests. The combination of SD-OCT with fundus-examination provided a marginal increase in sensitivity over OCT alone, but the associated incremental cost-effectiveness ratios was >GBP 100,000 per QALY.ConclusionsThe efficiency of diagnostic pathways for nAMD may be improved by using SD-OCT alone to monitor the second eye of people being treated for unilateral disease. Prospective cohort studies embedded into routine practice offer value for informing decisions surrounding the use of technologies already in routine use.
PP02 Is Glycated Hemoglobin A Valid Surrogate Endpoint To Evaluate The Effectiveness Of Drugs In Diabetes Mellitus Studies?
Authors: Rivera Paola Andrea , Fiestas Fabián 
Published: December 2022

IntroductionIn the field of drug development and effectiveness evaluation, the use of surrogate endpoints is acceptable if they reliably predict a positive effect on clinical outcomes such as mortality or morbidity. Hemoglobin A1c (HbA1c) is a widely used surrogate endpoint in phase 3 and 4 clinical trials evaluating drugs in patients with diabetes mellitus (DM). The objective of this study was to investigate whether HbA1c is a valid surrogate endpoint for evaluating the effectiveness of antihyperglycemic drugs in DM trials.MethodsWe conducted a systematic review of randomized placebo-controlled trials evaluating the effect of a treatment on levels of HbA1c and clinical outcomes in patients with DM. The association between the effects of treatment on HbA1c levels and clinical outcomes was then investigated using regression analysis at the trial level. The correlation coefficients (R) were interpreted using the cut-off points suggested by the German Institute for Quality and Efficiency in Health Care (IQWiG). HbA1c was considered a valid surrogate endpoint if it demonstrated a strong association with clinical outcomes (i.e., the lower limit of the 95% confidence interval [CI] of R≥ 0.85).ResultsNineteen phase 3 or 4 randomized controlled trials (RCTs) were identified. All studies included adults with type 2 DM. None of the associations evaluated was strong enough to validate HbA1c as a surrogate endpoint for any clinical outcome: mortality (R 0.34, 95% CI: -0.14, 0.69); myocardial infarction (R 0.20, 95% CI: -0.30, 0.61); heart failure (R 0.08, 95% CI: -0.40, 0.53); kidney injury (R -0.04, 95% CI: -0.52, 0.47); and stroke (R 0.81, 95% CI: 0.54, 0.93).ConclusionsThe evidence from multiple placebo-controlled RCTs of antihyperglycemic drugs in patients with type 2 DM suggests that a reduction in levels of HbA1c does not meet the IQWiG criteria for a valid surrogate endpoint. Consequently, the risk-benefit ratio of antihyperglycemic drugs in terms of patient relevant clinical outcomes, regardless of their hypoglycemic effect, should be the focus of therapeutic, regulatory, and reimbursement decisions.
PP11 Impact Of Qualitative Research In The Spanish Network Of Health Technology Assessment
Authors: Toledo-Chávarri Ana , Triñanes Yolanda , Ramos-García Vanesa , Perestelo-Pérez Lilisbeth , Reviriego Eva 
Published: December 2022

IntroductionQualitative research is being increasingly integrated in heath technology assessments (HTA) within the Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS). Qualitative research methodological guidelines are given in RedETS HTA guidelines and the Patient Involvement Strategy. A specific methodological guideline to systematically review qualitative studies was published in 2007 and is pending its update. The impact of their implementation is unknown. The aim of this work is to analyze the techniques, impact and reporting of qualitative research (primary and secondary) in HTAs.MethodsA manual search of the HTAs published in the last 5 years in RedETS was conducted to locate assessments that include qualitative research. To ensure a complete identification, RedETS agencies and units were consulted to provide information about the assessments that have used qualitative techniques in their development over the past 5 years. A content analysis of the selected assessments was conducted to analyze the techniques, impact and reporting of qualitative research in HTA.ResultsIn the past five years, focus groups, semi-structured interviews, evidence synthesis of observational studies including qualitative studies have been used and integrated in HTA in RedETS. Most of them have been linked to patient involvement facilitation or the inclusion of patient perspectives in HTA. Qualitative research has been used to analyze patient’s experiences and values, to elicit and select important outcome measures for patients, to research for barriers-facilitators for technology implementation and to inform evidence to decision frameworks.ConclusionsQualitative primary and secondary research is being used in HTA in Spain. It is mainly linked to patient involvement strategies both to elicit patient perspectives directly or to collect patient-based evidence. The impact of qualitative research in HTA is broad and diverse, extending from the scope of the assessments to the drafting of the recommendations.
PP12 Challenges In Assessing The Efficacy Of Non-Pharmacological Measures In The Context Of The COVID-19 Pandemic
Authors: Aguilera-Cobos Lorena , Isabel-Gómez Rebeca , Blasco-Amaro Juan Antonio 
Published: December 2022

IntroductionThe outbreak of the COVID-19 global pandemic in 2020 has been a major challenge for the world’s population and governments. The lack of vaccines, the saturation of health systems, and its rapid spread forced governments to take non-pharmacological interventions (NPI) that had a high impact on the population. Assessing the efficacy of these measures is a challenge for health technology assessment bodies.MethodsThe main NPIs for which assessment was required were: mobility restrictions, social distancing, cancellation of events or reduction of seating capacity, closure or reduction of seating capacity in non-essential businesses, closure or limitation of seating capacity in educational establishments, and promotion of teleworking in potential jobs. The implementation of these measures at a global level provides a large population for the study of the impact of these measures. However, the challenges for their evaluation are numerous: •The joint implementation of these measures makes it difficult to evaluate them in an isolated manner.•The heterogeneity between countries and regions of the pandemic situation at the time when these measures are initiated and terminated.•The different accuracy in the application of the measures.•Heterogeneity in the quality and accessibility of public health services for citizens.ResultsOutcome variables to assess the effectiveness of these measures should include parameters related to:•Incidence variables: the number of new or accumulated cases in a given time range, the variation in the number of cases in a given time range and the proportion of positive tests.•Transmission variables: the basic reproductive number (R0) and the effective reproductive number (Rt).•Severity and mortality variables: the number or variation of hospitalizations, the number or variation of intensive care unit (ICU) hospitalizations and the number or variation of deaths.ConclusionsThe large number of available data, the heterogeneity of the measures, the differences between populations, the numerous outcome variables and the possible inclusion of mathematical modelling studies, are a methodological challenge for the HTA bodies.