bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP316 Patients’ Testimonials In The National Committee For Health Technology Incorporation In Brazilian Public Health System (Conitec) Meetings
Authors: Portugal Clarice , Prates Adriana , Losco Luiza , Floriano Fabiana , da Silva Odete , de Souza Andrea , Viana Bruna , Prado Corah , Canuto Vania 
Published: December 2021

IntroductionThe Department of Management and Incorporation of Technologies and Innovation in Health (DGITIS) acts as Conitec's Executive Secretariat. Among its attributions, it promotes the public/patient involvement in the health technology assessment (HTA) process. Recently, Conitec has been working on the inclusion of patient's testimonials about their illness experience in the plenary sessions, that is, the monthly meeting where technologies are assessed.MethodsTo support the action of including patient reporting in Conitec's HTA process, DGITIS developed research on HTA agencies websites worldwide. The main criteria was the inclusion of patients’ reports in their Committee meetings. DGITIS contacted some of these agencies and requested a listserv question to the International Network of Agencies for Health Technology Assessment (INAHTA) members. These findings supported the DGITIS for the inclusion of patient participation in Conitec's meetings, from the selection process to the actual participation.ResultsFor the Conitec's HTA process, the patients’ participation should occur in the prior session to the public consultation, guaranteeing the inclusion of their perspective since the recommendation process beginning. Hence, every demand for incorporation to be discussed at Conitec's meeting should be preceded by a public call for patients with the clinical condition. The DGITIS will also hold preparatory meetings, which will serve as moments for shared construction of knowledge and literacy.ConclusionsThe nomination process, so far, has been grounded as a consensus among the patients. Thus, Conitec acts as a mediator, connecting the involved stakeholders, in a way that they can autonomously organize themselves and indicate the main representative and an alternate one. With the inclusion of the patient's perspective in the Conitec's meeting, another form of patient participation was opened in the HTA process. Therefore, the consolidation of this participation space is feasible and contributes to enrich the Brazilian HTA process.
OP321 The Scale And Variation Of The Impact Of COVID-19 On Prescribing Of Medicines In Primary Care In Wales
Authors: Hardy Will , McManus Dan , Murphy Susan , Hughes Dyfrig 
Published: December 2021

IntroductionPrescribing of medicines in primary care in Wales has been exceptional in 2020 due to COVID-19 and the associated changes to the delivery of health services. The changes are likely to have harmful, albeit unintended, consequences, including disruption of pharmacy stock management; unpredictable changes in prescribing; and interruption to patients’ supply of medicines and reduced medication adherence. Changes in prescribing are unlikely to be distributed evenly across the country or population. Therefore, this study aimed to identify changes in GP prescribing compared with previous years, the variation of these changes, and factors related to the variation in changes, to identify patient subgroups for whom the impact is disproportionate.MethodsWe identified medicines of interest where concerns around prescribing have been raised and, for each of these medicines, retrieved monthly prescribing data for each GP practice in Wales (N = 492). We then linked these data with other publicly available data (for example, practice size, indices of multiple deprivation, disease prevalence).We developed a novel approach to measure the impact of COVID-19 on GP prescribing. We compared observed with expected prescribing volume projected via time series modelling and differences were related to patient and practice characteristics using general estimating equations.ResultsThere was evidence of stockpiling of medicines during March 2020 (for example, oral-contraceptives and oral-anticoagulants with 11.6 and 18.5 percent increases from March 2019), followed by a short-term reduction in prescribing for oral-contraceptives (a reduction of 12.9 percent), but not oral-anticoagulants (an increase of 6.5 percent). However, GP level data show considerable deviation from the national trend for several GPs, which may be due to health and socio-demographic factors.ConclusionsCOVID-19 has had a major impact on primary care prescribing in Wales. The distribution of changes in prescribing will not be even across the country or the population. Identification of systematic variation in impacts on prescribing could identify geographical areas or patients in need of additional support to ensure uninterrupted and appropriate access to medicines.
OP440 Comparison Of Evidence Supporting Cancer Drug Approvals And Prices In The US And Brazil
Authors: Brummell Adriana Ivama , Naci Huseyin 
Published: December 2021

IntroductionCancer drug prices are high on the policy agenda worldwide. Previous research found no association between cancer drug benefits and prices at the time of regulatory approval. Drugs approved in the US with uncertain benefits may have spill-over effects in other settings. Our objective was to compare the evidence supporting cancer drug approvals in the US and Brazil, and to examine the association between cancer drug prices and availability of added therapeutic benefit.MethodsWe matched all novel cancer drugs approved in the US from 2010–2019 to approvals in Brazil. We extracted data on pivotal study design characteristics and outcomes in the US and Brazil, and evidence supporting price approval in Brazil, including availability of added therapeutic benefit.ResultsFrom 2010–2019, fifty-six cancer drugs with matching indications were approved in US and Brazil and had their prices authorized in Brazil by December 2020. Drug were available in Brazil following a median 522 days after US approval (IQR: 351–932). In the US, thirty-four (60.7 percent) of the drugs had pivotal randomized controlled trials (RCTs) and Twelve (21.4 percent) had overall survival benefit. By the time of Brazilian approval, forty-one (73.2 percent) drugs had pivotal RCTs and twenty-two (39.3 percent) had overall survival benefit. A total of twenty-eight (50 percent) drugs did not demonstrate added therapeutic benefit over other authorized drugs for the same indication and had a median reduction from requested to approved price of 6.1 percent (IQR: 0–27.8 percent) in Brazil. The twenty-seven (48.2 percent) drugs with added therapeutic benefit had a median price reduction of 2.0 percent (IQR: 0–9.2 percent).ConclusionsHalf of new cancer drugs approved in Brazil failed to demonstrate added therapeutic benefit. The Brazilian pricing system secured considerable price reductions, ensuring that prices for medicines with no added therapeutic benefit were not higher than existing treatments for the same approved indication. Although evidence was more mature by the time of Brazilian review, pivotal studies often lacked randomization and overall survival endpoints.
OP456 Encouraging Shared Decision-Making Of Goals Of Care Discussions In Lung Cancer Patients Using A Smartphone Application
Authors: Lovato Amanda , Almeida Nisha 
Published: December 2021

IntroductionAn important reason for receiving non-beneficial treatment at end-of life is the lack of timely discussions on goals of care and end-of-life preferences. A recent randomized clinical trial demonstrated that patients primed with a questionnaire on their end-of-life preferences were more likely to initiate such conversations with their doctors. Our objective is to integrate the questionnaire into a smartphone application to facilitate early goals of care discussions. To achieve this goal, we first plan to undertake a feasibility study to understand stakeholder preferences.MethodsAs part of a quality improvement initiative at our Canadian quaternary-care hospital, we conducted focus groups with oncology and palliative care physicians and patients to understand barriers to early conversations on end-of-life preferences, and to assess feasibility of using smartphone technology in facilitating these conversations. The app would integrate a questionnaire to patients and send prompts to physicians on patient readiness and timing of conversations.ResultsWe conducted separate focus groups with lung cancer patients (n = 6) and clinicians in oncology (n = 6) and palliative care (n = 6). Clinical teams expressed enthusiasm about early conversations but raised several barriers including system (lack of electronic documentation and access to data; multiple physicians), clinician (lack of time) and patient (stigma associated with end-of-life) barriers. Clinicians agreed that an app could overcome some of these barriers such as access to patient and electronic data by making patients the repository of all their data and empowering them to initiate discussions. However, they raised concerns about universal accessibility of such technology, especially among the elderly. Patient focus groups will take place in March 2021 and inform us on feasibility in this population.ConclusionsThere is a consensus among physicians at our hospital that early end-of-life conversations have the potential to mitigate adverse events and that use of a smart phone app could facilitate such conversations.
PP152 Epigenetic In Vitro Diagnostic Test For Early Diagnosis In Lung Cancer: An Early Assessment
Authors: Hijas-Gómez Ana Isabel , Polo-de-Santos Mar , Luengo-Matos Setefilla , Sánchez-Gómez Luis Maria 
Published: December 2021

IntroductionLung cancer is a leading cause of morbidity and mortality, and early diagnosis is essential for patient survival. Epigenetics is an innovative discipline that provides biomarkers to aid in early diagnosis, patient risk classification, or outcome prediction. Each type of tumor may present specific patterns of gene methylation, the analysis of which may be useful as a diagnostic tool. The aim of this study was to conduct an early assessment of novel in vitro diagnostic (IVD) tests based on the identification of DNA hypermethylation epigenetic signatures developed for the early detection of lung cancer.MethodsWe identified this technology through the Early Awareness and Alert System “SINTESIS-new technologies” of the Agencia de Evaluación de Tecnologías Sanitarias - Instituto de Salud Carlos III. A literature search of PubMed, the Trip Medical Database, the International Clinical Trials Registry Platform, ClinicalTrials.gov, and the Cochrane Central Register of Controlled Trials was conducted. Studies published up to November 2019 were reviewed.ResultsThree tests were identified. Epi proLung® analyzes the hypermethylation status of SHOX2/PTGER4 genes in blood samples using polymerase chain reaction (PCR) and showed good discrimination capacity with respect to healthy controls (area under the curve [AUC] = 0.91) and patients with non-malignant lung diseases (AUC = 0.86). The Epi proLung BL Reflex Assay® for determining the hypermethylation state of the SHOX2 gene in bronchoalveolar lavage samples by PCR had modest sensitivity (69%, 95% confidence interval [CI]: 64–75) and high specificity (96%, 95% CI: 97–100). A test in development for determining the hypermethylation state of BCAT1/CDO1/TRIM58/ZNF177 genes in aspirated or bronchoalveolar lavage samples by pyrosequencing yielded a sensitivity of 85 percent and a specificity of 81 percent, with an AUC of 0.91 at the optimal cutoff point.ConclusionsThe evidence for the three tests showed promising results in terms of diagnostic validity. However, although personalized medicine is becoming increasingly widespread in the field of cancer diagnosis, more studies are needed to evaluate the clinical utility of these diagnostic tests, either as a complementary or a screening test, and the economic impact of their use.
PP180 Optimal Treatment Sequence For Targeted Immune Modulators For The Treatment Of Moderate To Severe Ulcerative Colitis
Authors: Bloudek Lisa , Ollendorf Dan , Pandey Rajshree , Fazioli Katherine , Carlson Josh 
Published: December 2021

IntroductionSeveral targeted immune modulators (TIMs) have demonstrated effectiveness in moderate-to-severe ulcerative colitis, including adalimumab, golimumab, infliximab, infliximab biosimilars, tofacitinib, ustekinumab, and vedolizumab. In addition to assessing individual TIMs, evaluating TIM sequences can inform clinical care as well as coverage and reimbursement policies. Our objective was to identify optimal treatment sequences based on maximum net health benefit (NHB), lowest total cost (cost minimizing), quality-adjusted life-year (QALY) maximization, or convenience (avoidance of intravenous treatments), and to evaluate their cost effectiveness compared with conventional treatment from the health sector perspective.MethodsWe developed a Markov model with eight-week cycles and a lifetime time horizon. The health states were active, clinical response without remission, remission, and death. TIM efficacy was informed by a network meta-analysis conducted by the Institute for Clinical and Economic Review. Sequences were generated by ranking TIMs and then conventional treatment according to NHB, cost minimization, QALY maximization, or convenience and combining top ranked TIMs in the biologic naïve and biologic experienced populations. NHB was calculated at USD 150,000 per QALY. Probabilistic sensitivity analysis (PSA) was undertaken to estimate the probability of each sequence having the highest NHB rank, QALY maximizing rank, and cost-minimizing rank.ResultsTwenty-one sequences were evaluated. The sequence with the highest NHB was infliximab followed by tofacitinib (-0.12 QALYs), which also had the lowest incremental costs (USD37,266). For orally and subcutaneously administered TIMs, the sequence of golimumab-tofacitinib had the highest NHB (-0.34 QALYs). Ustekinumab-vedolizumab was not only the top ranked sequence as measured by QALY maximization (0.172 incremental QALYs), but it also had the highest total incremental cost (USD166,094). Results of the PSA were consistent with deterministic rankings for the top-ranking sequences and showed that the top two or three regimens were close in magnitude.ConclusionsThe optimal sequence with regard to NHB and cost minimization was infliximab or biosimilars, followed by tofacitinib, adalimumab, or vedolizumab. Sequences that generated the most QALYs began with ustekinumab, followed by vedolizumab, tofacitinib, and adalimumab.
PP206 Health Technology Assessment Guidance In The United Kingdom: Addressing Issues Specific To Medical Devices
Authors: Gibson Scott , Saunders Sita , Hedblom Amanda Hansson , Blüher Maximilian , Torres Rafael Torrejon , Saunders Rhodri 
Published: December 2021

IntroductionThe United Kingdom spends approximately GBP4.2 billion (USD5.6 billion; EUR4.7 billion) each year on medical devices, but healthcare providers receive little health technology assessment (HTA) guidance on cost-effective device procurement. Our objective was to assess the availability of HTA guidance for medical technologies and to identify key challenges related to the economic assessment of these technologies.MethodsNational Institute for Health and Care Excellence technology appraisal (TA) and Medical Technologies Evaluation Programme (MTEP) appraisals published online between November 2009 and October 2020 were identified. The “case for adoption” recommendation, type of devices, and critiques of economic analyses for each MTEP appraisal were extracted and categorized.ResultsIn comparison to 415 publicly available TAs for pharmaceuticals, only 45 medical technologies have been appraised through the MTEP. MTEP-submitted technologies can be categorized into diagnostic (7), monitoring (3), prophylaxis (5), therapeutic (28), and other (2). Furthermore, 11 were implants, seven were used by patients, and 27 had provider interaction. Major points of MTEP criticism were a failure to model cost consequences, training costs, and organizational impact. There was also the barrier of transferring costs across budgeting divisions.ConclusionsIn comparison to HTA guidance for pharmaceuticals, there is a dearth of medical device guidance. Therapeutic and implantable devices appear to be disproportionately overrepresented in the MTEP process. This may be because their appraisal is most akin to pharmaceuticals, for which HTA processes are well established. To encourage more HTAs of medical devices, HTA guidance should elaborate on issues specifically related to medical devices.
PP283 Living Systematic Reviews In Time Of COVID-19: An Innovative Approach To Decision-making In An Environment Of Changing Evidence
Authors: Paz-Valiñas Lucinda , Mejuto-Martí Teresa , Casal-Acción Beatriz , Triñanes-Pego Yolanda , Maceira-Rozas María del Carmen , Cantero-Muñoz Paula Gaudalupe , Puñal-Rioboó Janet , Rodríguez-González del Blanco Paula Sabela , Faraldo-Vallés María José 
Published: December 2021

IntroductionThe management of the COVID-19 pandemic is a challenge for Health Technology Assessment (HTA) methodology due to the need to formulate evidence-based recommendations in times of uncertainty in minimal time - for a large number of publications and with changing or even contradictory information. Living systematic reviews (LSRs) are systematic reviews that are continually updated, incorporating relevant new evidence as it becomes available. Since the COVID-19 pandemic fits all criteria to perform LSRs: (i) the Review question is a particular priority for decision-making, (ii) there is an high level of uncertainty about the existing evidence, and (iii) there is likely to be emerging evidence that will impact on the conclusions of the LSR, the aim of which is to analyze the role of LSRs as an innovative approach to HTA in recent years, and its impact on the management of the pandemic.MethodsA systematic search of LSRs (published or protocols) was run on the main biomedical databases (Medline, Embase and Cochrane Library) in November 2020 and it was rerun in June 2021 without time limit. The results will be analyzed and classified by year and category (epidemiology, treatment, prognosis, symptoms, diagnosis and vaccines).ResultsThe literature research has returned a total of 187 publications. The LSR concept emerged in 2014, from which some LSRs began to be published, but an exponential increase has been observed in 2020 with 76 references of which 66 percent were focused on the SARS-CoV-2. By category, 81.8 percent were focused on treatment, 41.8 percent on epidemiology, 20.9 percent on rehabilitation, 15.1 percent on diagnosis, 10.2 percent on prognosis and 2.2 percent on symptoms until June 2021. There wasn't any LSR for vaccines and 28 percent was focused on other fields.ConclusionsLSRs are particularly important during the COVID-19 pandemic, with research evidence emerging rapidly, current evidence being uncertain, and new research changing policy or decisions on health. The majority of LSRs published up to June 2021 were focused on the treatment of COVID-19.
PP293 Tiered Rapid Response Products In The Evidence Directorate Of Healthcare Improvement Scotland
Authors: Anand Neil , Campbell Evan , Macgann Tracey , Macpherson Karen , Muniz Tomas 
Published: December 2021

IntroductionThe Evidence Directorate produced eighteen rapid responses during the early stages of the COVID-19 pandemic. To address this need while retaining methodological integrity a three-tiered system for rapid responses was developed.MethodsAll rapid responses answer specific research questions rather than broad health system issues. The appropriate level varies depending on the time and resource available, and the requester's need:
•Level 1 – Reference List (turnaround 4–8hrs, delivered by an information scientist): a quick search for best available evidence, and results presented as a reference list.•Level 2 – Summary of evidence (turnaround 1–2 days, delivered by an information scientist): a quick search and brief summary of the best available evidence.•Level 3 – Synthesis of evidence (turnaround 3–7 days, delivered by a Health Services Researcher or Health Economist): a quick search and then a narrative summary and synthesis of the best available evidence, with a brief appraisal of validity, reliability and generalizability.ResultsSince the launch of the three-tiered model in September 2020 there have been five rapid responses. Two were Level 2 products and three were Level 3 products.ConclusionsThe Evidence Directorate of Healthcare Improvement Scotland now has an agile rapid response product which can be applied to a variety of settings and needs. This was borne out of a need for a rapid turnaround and evidence synthesis during the COVID-19 pandemic.
PP297 Management Of Sudden Onset Severe Headache Presenting To The Emergency Department: A Systematic Review
Authors: Wade Ros , Walton Matthew , Harden Melissa , Hodgson Robert , Eastwood Alison , Storey James , Hassan Taj , Randall Marc , Hassan Abu , Williams John 
Published: December 2021

IntroductionSudden onset severe headache is usually caused by a primary headache disorder but occasionally is secondary to a more serious problem, such as subarachnoid hemorrhage (SAH). Guidelines recommend non-contrast brain computed tomography (CT) followed by lumbar puncture (LP) to exclude SAH. However, guidelines pre-date the introduction of more sensitive modern CT scanners. A systematic review was undertaken to assess the clinical effectiveness of different care pathways for the management of headache in the Emergency Department.MethodsEighteen databases (including MEDLINE and Embase) were searched to February 2020. Studies were quality assessed using criteria relevant to the study design; most studies were assessed using the QUADAS-2 tool for diagnostic accuracy studies. Where sufficient information was reported, diagnostic accuracy data were extracted into 2 × 2 tables to calculate sensitivity, specificity, false-positive and false-negative rates. Where possible, hierarchical bivariate meta-analysis was used to synthesize results, otherwise studies were synthesized narratively.ResultsFifty-one studies were included in the review. Eight studies assessing the accuracy of the Ottawa SAH clinical decision rule were pooled; sensitivity was 99.5 percent, specificity was 23.7 percent. The high false positive rate suggests that 76.3 percent SAH-negative patients would undergo further investigation unnecessarily. Four studies assessing the accuracy of CT within six hours of headache onset were pooled; sensitivity was 98.7 percent, specificity was 100 percent. CT sensitivity beyond six hours was considerably lower (≤90%; 2 studies). Three studies assessing LP following negative CT were pooled; sensitivity was 100 percent, specificity was 95.2 percent. LP-related adverse events were reported in 5.3–9.5 percent of patients.ConclusionsThe evidence suggests that the Ottawa SAH Rule is not sufficiently accurate for ruling out SAH and does little to aid clinical decision making. Modern CT within six hours of headache onset (with images assessed by a neuroradiologist) is highly accurate, but sensitivity reduces considerably over time. The CT-LP pathway is highly sensitive for detecting SAH, although LP resulted in some false-positives and adverse events.