bluuebunny/crossref_metadata_2025_split huggingface dataset:
PD30 Radioactive Seed Localization And Radio-Guided Occult Lesion Localization For Non-Palpable Breast Cancer Surgery: A Meta-Analysis
Authors: Ferreira Hortência , Rostelato Maria 
Published: December 2022

IntroductionNon-palpable breast cancers require intraoperative localization to guide the surgical procedure. The radio-guided occult lesion localization (ROLL) and radioactive seed localization (RSL) techniques use radioactive material (technetium-99m labeled macroaggregated albumin and iodine-125 seeds, respectively) implanted at the lesion site. The success of conservative surgery depends on complete tumor excision with negative surgical margins. The objective of this study was to perform a meta-analysis of the surgical effectiveness of the ROLL and RSL techniques with respect to rates of positive surgical margins, reoperation, and recurrence.MethodsA systematic search of the PubMed, Embase, LILACS, SciELO, and Web of Science databases was performed on 2 August 2021. A standard form was used to extract data from the studies selected in the screening process. The ROBINS-I tool was used to analyze risk of bias and RevMan 5.4 software was used to perform the meta-analysis.ResultsFour observational studies met the inclusion criteria. The overall evidence quality was moderate. The studies included women aged from 28 to 91 years with non-palpable breast cancer. The results demonstrated similar effectiveness between RSL and ROLL for rates of positive surgical margins (risk ratio [RR] 0.83, 95% confidence interval [CI]: 0.50, 1.39; 763 patients) and reoperation (RR 1.14, 95% CI: 0.75, 1.74; 1,550 patients). Regarding the rate of disease recurrence, RSL was superior to ROLL (RR 0.50, 95% CI: 0.29, 0.87; 939 patients).ConclusionsThe results demonstrate that the ROLL and RSL techniques are equivalent with respect to rates of positive surgical margins and reoperation, although patients undergoing RSL had lower rates of disease recurrence. However, there is a tendency to favor the RSL technique because of the longer interval between implantation and surgery, which is possible due to the longer half-life of iodine-125 (59.4 days). This also means that radioactive seed implantation can occur before neoadjuvant chemotherapy, so the tumor bed remains marked if further interventions are required, obviating the need for another invasive procedure before surgery.
PD37 High-Dose Vitamin D For The Treatment Of COVID-19
Authors: Stürzlinger Heidi , Pentz Richard 
Published: December 2022

IntroductionThe aim of this EUnetHTA (European Network for Health Technology Assessment) Rolling Collaborative Review on high dose vitamin D for the treatment of COVID-19 was to inform health policy at an early stage in the life cycle of therapies and to monitor ongoing studies in the format of a Living Document.MethodsThe systematic literature search was conducted in Medline, Pubmed, medRxiv, bioRxiv, arXivso, Cochrane COVID-19 Study Register, ClinicalTrials.gov, ISRCTN Registry, EU Clinical Trials Register. The first search was done in January 2021, and the last in November 2021. English and German randomized controlled studies (RCTs) investigating treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infected individuals with high dose vitamin D2, D3 or their metabolites were included if examining mortality, length of hospital stay, viral burden, clinical progression, hospitalization rates, intensive care unit (ICU) admission, mechanical ventilation, quality of life or adverse events. Two reviewers independently screened search results and assessed risk of bias and certainty of evidence. One reviewer extracted study data, checked by another.ResultsOf the nine RCTs published to date, two investigate calcifediol, one calcitriol and six vitamin D3. All used different dosing regimens. Disease severity and proportion of vitamin D deficiency varied between studies. Calcifediol treated patients in one study required significantly less ICU admissions than untreated patients. Vitamin D3 in another study led to significantly more SARS-CoV-2 PCR-negative patients before day 21 than placebo. There were no other significant differences between groups. Twenty-five RCTs are ongoing, five of them with over 1,000 patients.ConclusionsThe current evidence is heterogenous regarding form and dosage of vitamin D, baseline disease severity and baseline vitamin D deficiency. There is currently no standardized/recommended level of what constitutes a (beneficial) “high dose”. Most results did not show significant differences between vitamin D treated groups and no vitamin D / placebo groups. Many of the studies are very small and certainty of evidence is predominantly low or very low.
PD40 Antigen Diagnostic Tests With Self-Collection Of Biological Material For The Diagnosis Of COVID-19
Authors: Ramos Maira , Camargo Erika , Maierovitch Claudio , Elias Flávia 
Published: December 2022

IntroductionThe self-test for COVID-19 has been a widely used strategy in some countries, especially in the context of back to face-to-face work and educational activities. However, it is necessary to discuss the accuracy of antigen tests for the diagnosis of COVID-19.MethodsA systematic review was carried out. The strategy was defined by the researchers using the terms “Covid-19” and “Self-testing” and their respective synonyms, including studies with data collection from 01/01/2021. Searches were carried out on October 20, 2021, in several databases.ResultsA total of 504 studies were identified, four of which were included in this review: two self-tests of nasopharyngeal collection antigen compared to reverse transcriptase polymerase chain reaction (RT-PCR); a supervised and self-collected anterior nasal smear self-test; and a study that evaluated the performance of six self-collected rapid antigen tests against quantitative RT-PCR (gargle, sputum, and spit). Saliva self-tests were found to have low sensitivity (<45%), while anterior nasal or nasopharyngeal swab self-tests had greater than 80 percent sensitivity. In all self-tests, the specificity was less than 85 percent. The diagnostic accuracy of self-tests for the different SARS-CoV-2 variants was not identified.ConclusionsThe use of self-tests as a screening strategy is recommended, being a strategy with a significant impact on the surveillance and control of SARS-CoV-2 transmission. Further studies are needed to assess: (i) accuracy considering the concern variants, (ii) safety of tests with self-collection of biological material, and (iii) disposal of biological waste.
PD41 Role Of Artificial Intelligence In Improving Access To COVID-19 Diagnosis During Pandemic
Authors: Galvan Pedro , Fusill Jose , Gonzalez Felipe , Rivas Ronald , Grossling Benicio , Ortellado Jose , Portillo Juan , Borba Julio , Hilario Enrique 
Published: December 2022

IntroductionThe evolution of advances in informatics, technology in medicine, and artificial intelligence (AI) offers opportunities to enhance health care during the coronavirus disease 2019 (COVID-19) pandemic. The challenge for biomedical engineers is to implement these developments in clinical practice to improve global health. Populations living in low-income countries do not have access to specialist care and quality diagnostic services for COVID-19. Therefore, an AI system based on a telemedicine platform for diagnosing COVID-19 could help mitigate the lack of highly trained radiologists at regional hospitals and serve as a triage system for rationalizing the use of reverse transcription polymerase chain reaction (RT-PCR) testing and other health resources in low-income countries. Thus, the utility of an AI system for diagnosing COVID-19 in Paraguay was investigated.MethodsThis is a descriptive multicenter observational feasibility study of an AI tool for the rapid detection of COVID-19 in chest computed tomography (CT) images of patients with respiratory difficulties who attended public hospitals across the country.ResultsBetween March 2020 and August 2021, 3,514 rapid diagnostic tests were carried out on patients with respiratory disorders to rule out COVID-19 in 14 hospitals nationwide. The average age of the patients was 48.6 years (52.8% were men); the most common age ranges were 27 to 59 years, followed by older than 60 years and 19 to 26 years. The most frequent findings on the CT images were severe pneumonia, bilateral pneumonia with pleural effusion, bilateral pulmonary emphysema, diffuse ground glass opacity, hemidiaphragmatic paresis, calcified granuloma in the lower right lobe, bilateral pleural effusion, sequelae of tuberculosis, bilateral emphysema, and fibrotic changes. Overall, there was 93 percent agreement and 7 percent discordance between the AI system and the RT-PCR test results. Compared with RT-PCR testing, the AI system had a sensitivity of 93 percent and a specificity of 80 percent.ConclusionsParaguay has an AI-based telemedicine screening system for the rapid detection of COVID-19 that uses chest CT images of patients with respiratory conditions.
PD42 Diagnosis Of Chronic Diseases During The COVID-19 Pandemic Through Telemedicine
Authors: Galvan Pedro , Rivas Ronald , Grossling Benicio , Ortellado José , Arbo Carlos , Portillo Juan , Borba Julio , Hilario Enrique 
Published: December 2022

IntroductionThe diagnosis and management of chronic diseases during the coronavirus disease 2019 (COVID-19) pandemic was one of the biggest challenges facing healthcare systems globally, especially in low-income countries. Since basic health care for chronic diseases can overwhelm the capacity of conventional face-to-face healthcare services, there is growing interest in using information and communication technology and telemedicine to improve access to medical services that are often not consistently available in rural communities. In this context, telemedicine tools should be directed toward maintaining basic health services for patients with chronic conditions in rural and underserved hospitals. This study evaluated a telemedicine system in remote public hospitals in Paraguay to demonstrate how telemedicine improved access to tertiary level diagnostic services for patients with chronic conditions.MethodsThis descriptive study evaluated the use of telemedicine for diagnosing patients in remote public hospitals to improve provision of basic health services to patients with chronic disease during the COVID-19 pandemic. The type and frequency of diagnostic studies performed were determined.ResultsDuring the study 677,023 telediagnoses were performed in 67 hospitals. The 435,568 electrocardiograms performed in 61 hospitals indicated normal physiology (60.1%), unspecified arrhythmias (10.5%), and sinus bradycardia (8.4%). The 227,360 teletomography tests performed in 12 hospitals were undertaken on the head (52.4%) because of trauma (motorcycle accidents) and cerebrovascular diseases, chest (15.8 %), and other anatomical regions. The 14,076 electroencephalograms performed in 19 hospitals were undertaken for antecedents of seizure (53.3%), disease progression controls (14.0%), and headache (12.5%). Nineteen prenatal ultrasound scans were conducted.ConclusionsAlthough the results are promising for using telemedicine to bridge gaps and improve equity in the provision of basic health services for patients with chronic diseases in remote locations during the COVID-19 pandemic, a widespread use assessment should be undertaken before this tool is adopted.
PD47 Associations Of Orphan Designation And Other Drug Development-Related Factors On Rollout Times And Health-Technology-Assessment Recommendations Of New-Active-Substances
Authors: Sola-Barrado Belen , Wang Tina , McAuslane Neil 
Published: December 2022

IntroductionThe orphan designation has been used by the European Medicines Agency to incentivize the development of drugs treating rare diseases with high-unmet medical needs by supporting their development process and economic returns. This study evaluated the impact of the regulatory orphan designation and other drug development-related factors on the rollout times and Health-Technology-Assessment (HTA) recommendations of new active substances (NASs).MethodsA total of 656 HTA appraisals from 6 European countries were collected for NASs that received regulatory approval between 2012 and 2020. Multivariable logistic (positive and positive with restrictions vs. negative HTA recommendation as dependent variable) and linear regression (rollout time as dependent variable) models examined associations with regulatory orphan designation, expedited process, product type (biotechnological vs chemical), and jurisdiction (France, England, Germany, Poland, Scotland and Sweden). Rollout time was defined as months elapsed from regulatory submission to HTA recommendation (mean± standard deviation).ResultsMultivariable logistic regression analysis identified disparities in HTA recommendations between countries. Every month increase in rollout time conferred a 3 percent reduction in the odds of a positive recommendation (p<0.001). Review and product type did not show associations with HTA recommendation. Interestingly, orphan products showed a 99% increase in the odds of obtaining a positive HTA recommendation compared to non-orphan (p-value=0.003). We found 244 appraisals (37%) assessing an orphan product, of which 202 (83%) received a positive HTA recommendation.Multivariable linear regression analysis indicated that orphan products presented a 4.4-month rise in rollout time when compared to non-orphan products (p<0.001). The mean rollout time in months for orphan products were 25±12 in France, 30±15 in England, 21±9.1 in Germany, 37±16 in Poland, 25±12 in Scotland and 27±14 in Sweden.ConclusionsOrphan designated products showed greater odds of receiving a positive HTA recommendation compared with non-orphan. A more detailed review of orphan products could result in their longer rollout time compared with non-orphan counterparts. Considerable differences were found between HTA recommendations and rollout times between jurisdictions.
PD49 Burden And Cost Of Anterior Cruciate Ligament Reconstruction And Reimbursement Of Its Treatment In Indonesia: An Observational Study
Authors: Deviandri Romy , van der Veen Hugo C , Lubis Andri MT , van den Akker-Scheek Inge , Postma Maarten 
Published: December 2022

IntroductionThe number of anterior cruciate ligament reconstruction (ACLR) procedures is increasing. However, the likelihood of not allocating sufficient funds for the ACLR procedure in a developing country, especially in Indonesia, is high. This study aimed to analyze costs for ACLR procedures in Indonesia’s resource-limited context, determine the burden of ACLR, and propose national prices for ACLR reimbursement.MethodsA retrospective observational study was conducted on the cost of ACLR from a payer perspective using inpatient billing records from 1 January 2019 to 31 December 2019 from four hospitals. The national burden of ACLR was calculated and national prices for reimbursement were developed.ResultsOf the 80 ACLRs performed, 53 (66%) were isolated ACLRs and 27 (34%) were combined with meniscus treatment. The mean hospital costs incurred per ACLR procedure were USD 2,853 (IDR 40.4 million), which was mainly attributed to the orthopedic implants (USD 1,387; IDR 19.6 million). The costs of ACLR with combined meniscus treatment were estimated to be 35 percent higher than for isolated ACLR. The national burden of ACLR revealed a total budget of USD 367.4 million (IDR 5.2 trillion) per 100,000 patients for ACLR with additional meniscus treatment and USD 271.3 million (IDR 3.8 trillion) per 100,000 patients for the isolated ACLR procedure.ConclusionsACLR procedures in Indonesia are underbudgeted. Adjustment of reimbursement prices for ACLR procedures is needed to facilitate access for the Indonesian people. This study showed varying cost estimates for ACLR in Indonesia, necessitating a new reimbursement system that takes various clinical and patient factors into account.
PD52 The Role Of Public Consultation In CONITEC Recommendations Between 2012 And 2020: An Introductory Analysis
Authors: Souza Andrea Brigida , Portugal Clarice , Prates Adriana , Almeida Andrija , de Pina Viana Bruna Cabral , Losco Luiza , Canuto Vania 
Published: December 2022

IntroductionPublic consultation is a strategy for patient and public involvement (PPI) assured by the National Committee for Health Technology Incorporation in Brazilian Public Health System (CONITEC)´s normative framework. It aims to obtain society’s views on the matters under evaluation. It is made available after CONITEC issues an initial recommendation, which will be reviewed in light of society contributions. This paper examines the cases where the final recommendations differed from the initial ones in technology assessments carried out between 2012 and 2020, taking into account the arguments used by the CONITEC Plenary to support the modification.MethodsFrom a total of 361 public consultations referring to the assessment of health technologies carried out by CONITEC between 2012 and 2020, 40 final reports of health technology assessment (HTA) processes that had changes from the initial to the final recommendation were examined. Then, analytical categories were built so that justifications for the change were investigated and the interpretations produced. The empirical approach excluded public consultations regarding clinical protocols and therapeutic guidelines.ResultsIt was observed that, in 39 cases, the change occurred from an unfavorable position to a favorable position for the technology incorporation. The main reasons for changing the plenary’s decision were proposals to renegotiate the prices of technologies (that generate changes in the results of economic evaluation and budget impact analysis), the receipt of new evidence and experience, and opinion arguments sent mainly by health professionals.ConclusionsThe analyzed data has shown that the changes in recommendations are mostly based on the content of contributions which led to changes in the assessment of clinical evidence, economic evaluation and budget impact. Thus, it appears that public consultation has been consolidated as a relevant instrument to inform the deliberative process in HTA in Brazilian Public Health System.
PD53 Improving Patient Involvement In The National Institute For Health And Care Excellence’s Appeals Process
Authors: Livingstone Heidi , Pitan Maria 
Published: December 2022

IntroductionInvolving patients in the health technology assessment (HTA) lifecycle is a core principle at the National Institute for Health and Care Excellence (NICE) that helps build public confidence in healthcare decision-making. The last stage in this lifecycle is an appeal whereby stakeholders, including patient organizations, can appeal against the HTA committee’s decision based on two specific grounds: (i) the committee has failed to act fairly or NICE has exceeded its powers; and (ii) the recommendation is unreasonable considering the evidence submitted to NICE. Improving patient involvement in the appeals process was identified as a key area from consultative work undertaken with patient organizations in 2019.MethodsIn September 2020, surveys were sent to patient organizations for their feedback. The organizations received a survey tailored to their circumstances in relation to the following four outcomes.(i)An appeal was lodged that: (a) resulted in an appeal hearing; or (b) did not result in an appeal hearing.(ii)An appeal was not lodged but the organization had received: (a) negative guidance; or (b) ‘optimized’ guidance.ResultsSixteen responses were received across the four surveys. The key findings in priority order were as follows.(i)The legalist nature of appeal hearings is off-putting.(ii)The online appeals guide and template letter are not easy to use.(iii)Organizations would like more information on appeal hearings and timelines.(iv)Organizations would like patient-friendly materials and training on par with the support they receive for other HTA participation.ConclusionsAs a result of these findings, we are iteratively developing materials to support patient organizations, including:•a glossary;•a redesigned appeals web page with clearer timelines and a template letter;•a ‘Frequently Asked Questions’ document specifically for patient organizations; and•a video podcast from a lay appeals panel Chair explaining appeals in a patient-friendly way.We are also including a section on appeals in our introductory training for all patient organizations participating in medicines HTAs.
PD55 Evidence-Based Practices To Support Well-Being And School Success Of Children And Youth In Out-Of-Home Care
Authors: Goulet Julie , Maltais Christine , Noël Véronique , Archambault Isabelle 
Published: December 2022

IntroductionChildren and youth in out-of-home care face many challenges regarding their development and general well-being. It is necessary to put in place best practices to support them where they are most vulnerable. Providing recommendations to health and social services for best practices regarding social and academic success interventions, this study puts forward a synthesis method that combines empirical data and the expertise of key practitioners in the context of Quebec social services.MethodsA systematic review was first undertaken to identify the most effective interventions. Included studies (n = 31) were analyzed according to their methodological quality, collaboration processes, and type of care (foster home vs. residential care). To ensure the applicability of the recommendations made in the context of Quebec social services, contextual data, and clinical expertise were collected. Contextual data was gathered through local research reports, administrative data, and government documents. The expertise of multiple stakeholders was obtained in follow-up committees and semi-structured interviews (n = 4). In addition, to ensure their relevance and scope, recommended guidelines were debated in a deliberation committee.ResultsThe analysis between expert, contextual and empirical data led to several recommended evidence-based practices. In accordance with expert opinions, experimental and quasi-experimental studies show that various types of collaboration are beneficial for children and youth in out-of-home care. Notably, intersectoral collaborations were warranted in more complex situations (i.e., youth in residential centers), while partnership agreement was sufficient in less complex situations (i.e., children in foster homes). However, even if effective, some interventions are difficult to apply in real life and certain considerations must be taken into account (e.g. confidentiality issues, availability of resources).ConclusionsUtilizing three sets of data, guidelines have been proposed to help health and social services to identify best practices and promote the academic development of out-of-home care children and youth.