bluuebunny/crossref_metadata_2025_split huggingface dataset:
PP45 The Cost-Of-Illness Of Diabetic Macular Edema In Italy
Authors: Basile Michele , Calabrò Giovanna Elisa , Bandello Francesco , Varano Monica , Castronovo Giuseppe , Amore Filippo , Melchiorre Tiziano , Cicchetti Americo 
Published: December 2022

IntroductionDiabetic Macular Edema (DME) is an important complication of Diabetic Retinopathy (DR). Intravitreal steroids in slow-release systems represent a safe and effective therapeutic option for the management of DME, capable of improving patients’ quality of life by reducing the number of injections thus increasing the therapeutic adherence and the effectiveness of the treatment. This study aims to determine the economic impact of DME and the consequences, in terms of both expenditure and organizational impact, associated with a greater use of the intravitreal dexamethasone implant.MethodsThe analysis entailed the comparison between two scenarios: a first scenario based on the current use of therapeutic alternatives available in the Italian healthcare setting (as is) and an alternative scenario based on the assumption of an increased use of intravitreal dexamethasone implant (to be). The results of the analysis are expressed in terms of resource absorption associated with the two scenarios as well as in terms of the cost differential given by their comparison.ResultsDespite an increase in expenditure in terms of acquisition costs of pharmacological alternatives (EUR 898,362) and interventions provided (EUR 22,093,160), the greater use of prolonged-release dexamethasone allows for significant savings in terms of healthcare professionals’ time, follow-up and productivity losses incurred by patient/caregiver. These reductions in healthcare costs resulted in a saving of EUR 1,987,678 over a 5-year period. Such a reduction would allow, considering a total annual management cost of EUR 6,115 for the intravitreal dexamethasone, to treat 325 more patients at the same cost of the as is scenario based on the current rate of use of dexamethasone.ConclusionsIn a context characterized by the need to increase the allocative efficiency of economic resources, the recourse to therapeutic alternatives, such as prolonged release dexamethasone, allowing the reduction of costs for the management of a given pathology is crucial to generate more value for patients and the entire society.
PP56 The Use of Computed Tomography for Detecting COVID-19 Pneumonia: Rapid Evidence Review
Authors: Mideksa Samson , Ababor Sabit , Gebreyohannes Yosef , Bogale Firmaye , Solomon Dagmawit , Getachew Tsegaye , Ararso Desalegn , Wolde Ermias , Kebede Zelalem , Tollera Getachew 
Published: December 2022

IntroductionThe reverse transcription polymerase chain reaction (RT-PCR) test is the gold standard for detecting coronavirus disease 2019 (COVID-19), but recent studies have reported false negative results for RT-PCR. Consequently, several countries are looking at chest computed tomography (CT) for the diagnostic workup of patients with suspected or probable COVID-19 to inform clinical management. Therefore, this rapid review provides the best available evidence on the use of chest CT for detecting COVID-19 pneumonia.MethodsLiterature searches were conducted in the PubMed, Cochrane Library, JBI Library, Epistemonikos, and Evidence Aid databases for relevant papers published from 1 December 2019 to 12 June 2020. The search strategy was based on the identified population, concept, and context with respect to the objective of the review. The methodological quality of the seven systematic reviews identified was appraised using the AMSTAR checklist.ResultsThe use of CT as a first-line screening tool for COVID-19 is not beneficial. Nevertheless, for patients with suspected COVID-19 pneumonia who had a false-negative RT-PCR results, cross-checking with CT and a repeated RT-PCR test is essential to avoid misdiagnosis. Chest CT offered high sensitivity for detecting COVID-19 pneumonia among symptomatic individuals, especially in those with severe disease. It was also useful for evaluating the potential complications, disease severity, and progression of COVID-19 pneumonia. The features of CT images differed at the early, intermediate, and late stages of COVID-19 pneumonia, but the most common imaging findings were patchy and ground glass opacities. It was also found that diagnosing COVID-19 in children using CT is challenging.ConclusionsEven though chest CT is not useful for primary screening of COVID-19, it is useful for detecting later stage disease and for evaluating patients with COVID-19 pneumonia. For patients with suspected COVID-19 pneumonia and a false negative RT-PCR result, cross-checking with a chest CT and a repeat RT-PCR test is essential to avoid misdiagnosis.
PP59 Multidimensional Evaluation Of The Reducer Device In Patients With Refractory Angina
Authors: Cicchetti Americo , Rumi Filippo , Siviero Ludovica , Fortunato Agostino 
Published: December 2022

IntroductionTreatments for coronary heart disease patients have had major developments in recent decades, both in the pharmacological and interventional fields, and this has helped to prolong the survival of these patients. However, the growing number of patients who show persistent and disabling symptoms of angina proves that at the same time their quality of life has not been equally improved.MethodsWe conducted a multidimensional assessment coherent with health technology assessment methodology on the Coronary Sinus Reducer System (CSRS). CSRS is the latest line of therapy for patients with coronary artery disease who are ineligible for revascularization, demonstrate reversible ischemia, and have refractory angina pectoris (AP) despite optimal standard medical therapy. We performed a literature review in order to gather evidence on efficacy and safety of the device and on the economic and organizational impact of the procedure. In the economic domain we developed a cost-utility model based on a decision tree and a five-year time horizon budget impact model.ResultsSeveral studies in the literature have shown that this therapy is related to an increase in quality of life and an improvement in symptoms of refractory angina. The economic evaluations conducted show how the therapy, despite an increase in the resources absorbed in the first years of implementation, reaches a cost saving profile in the medium term due to positive outcomes, while leading to an increase in the quality of life in patients suffering from refractory angina.ConclusionsThe treatment of refractory angina remains a challenge for today’s medicine. Patients suffering from this condition are often described as “no option” patients. Thus, despite there is a need of further evidence to establish even more robustly the economic sustainability of the device, especially on its effectiveness in the medium-long term, the device should be taking into account in those patients who could benefit from it in terms of relieving the symptoms of angina and improving their quality of life.
PP68 Dexcom G6® Device For Diabetes During Pregnancy
Authors: Ramos-García Vanesa , Rivero-Santana Amado , Perestelo-Pérez Lilisbeth , Duarte-Díaz Andrea , Álvarez-Pérez Yolanda , Torres-Castaño Alezandra , Toledo-Chávarri Ana , Wägner Ana María , Rodríguez-Rodríguez Leticia , González-Rodríguez Carlos , Serrano-Aguilar Pedro 
Published: December 2022

IntroductionDiabetes mellitus (DM) is one of the most frequent metabolic complications associated with pregnancy, affecting both the prognosis of the pregnant woman and the newborn. Pregestational DM type 1 (T1DM) and type 2 (T2DM) and gestational DM (GDM) are associated with an increased risk of pregnancy complications such as miscarriage, fetal malformations, macrosomia, preeclampsia, and neonatal hypoglycemia, among others. The aim of this review was to evaluate the efficacy and safety of using the Dexcom G6 device (Dexcom, Co., USA) to continuously self-monitor blood glucose levels during pregnancy. This report was requested by the Spanish Ministry of Health.MethodsWe systematically searched for articles published to July 2021 in the MEDLINE, Embase, and Web of Science databases. We included experimental and observational primary studies addressing the safety, efficacy, and cost effectiveness of the Dexcom G6 device for gestational and pregestational diabetes.ResultsTwo non-comparative prospective studies were identified. One study of 25 pregnant women with T1DM, which evaluated glycemic control and complications during pregnancy and postpartum, reported stable hemoglobin A1c levels during gestation in women using the Dexcom G6 device. The percentage of time spent in the therapeutic glucose range (63 to 140 mg/dL) was 59 percent; 38 percent was in the hyperglycemic range and 3 percent was in the hypoglycemic range. Although some patients reported mild erythematous and edematous reactions to the sensor, no moderate or severe reactions or infections occurred at the sensor insertion site. The other study in pregnant women with T1DM (n=20), T2DM (n=3), or GDM (n=9) showed adequate accuracy of the Dexcom G6 device, compared with the reference method, especially when the sensor is placed on the arm.ConclusionsRandomized controlled trials are required to assess the effectiveness and safety of the Dexcom G6 device in maintaining adequate glucose control during pregnancy in women with DM. Studies are also needed to compare the Dexcom G6 device with conventional capillary blood glucose self-monitoring or other monitoring methods. No cost-effectiveness studies have been conducted for the Dexcom G6 device in this patient population.
PP74 Taking A Lifecycle Approach To Scottish Medicines Consortium Budget Impact Analysis
Authors: Booth Corinne , Dimitrova Maria , Henriquez Alex , Hislop Jennifer , Manson Jan , Wright Helen 
Published: December 2022

IntroductionThe Scottish Medicines Consortium (SMC) conducts early health technology assessment of new medicines in Scotland. While budget impact is not a factor in decisions on reimbursement, budget impact information is provided initially through horizon scanning reports for high impact medicines (estimated net budget impact >GBP 500,000 [EUR 585,710] per annum) to aid financial planning and implementation of advice at the local level, and later through budget impact templates from the submitting company issued alongside SMC advice. This research aimed to understand how the information is used and to evaluate the benefits of a lifecycle approach to budget impact analysis.MethodsHealth Board users of the budget impact templates were surveyed to explore the degree of utilization and identify areas for improvement, including the need to cross-validate the horizon scanning estimates with those of the submitting company. Responses were analyzed quantitatively and qualitatively, with comments coded in Nvivo (QSR International) and themes established through thematic analysis.ResultsThe initial responses received (n=17) provided representation from 57 percent of Health Boards (i.e., payers) covering 79 percent of the population. Preliminary results showed that while the budget impact templates were valued, 69 percent of respondents found them ‘somewhat useful’, suggesting scope for improvement. Almost half (48%) of the respondents used the templates for high impact medicines, with only 30 percent using them for all medicines. The majority (76%) of those surveyed thought there would be value in linking budget impact information throughout the SMC process. An emerging theme was that some users found the templates complex and inflexible, and that a simpler, more adaptable tool to aid the planning process would be welcomed. Priorities identified for improving template included adapting them to the local population and adjusting medicine prices to reflect confidential discounts.ConclusionsThis research suggests that budget impact information is valued by Health Boards and that there is strong support for linking budget impact estimates and engaging stakeholders throughout a medicine’s lifecycle. Simplifying the templates, increasing their adaptability, and providing guidance and training in their use will be key steps in improving this important part of SMC process.
PP84 Change Management Of Patient Associations In Italy: From Emergency Response To Organizational Learning
Authors: Di Brino Eugenio , Morandi Federica , Cicchetti Americo 
Published: December 2022

IntroductionThe role of associations dedicated to patient advocacy has assumed strategic importance within the most advanced health systems, including the Italian NHS. In this period of strong national and international emergency, the associations of citizens and patients have also changed their actions and have implemented others to alleviate the discomforts of sick people in Italy, collaborating with institutions and health services.MethodsData were collected using a semi-structured survey, with both yes / no and open questions, developed and administered by the Patient Advocacy LAB (ALTEMS- Catholic University of Sacred Heart) to 150 patient advocacy associations. The organizational changes and the initiatives adopted by patient associations during the COVID-19 emergency was investigated.ResultsThe majority of the initiatives adopted by patient advocacy associations during the COVID-19 pandemic have been introduced during the first wave (March- June 2020), and that most of them have been maintained to (December 2020). These initiatives included improvements and updating of the communication tools aimed at reaching the higher number of patients. Thanks to these new approaches, the empathy and the assistance to patients have been increased. In addition, a number of training initiatives have been developed online and they have been followed by a large number of patients and caregivers. At an operative level, during the pandemic, many patient advocacy associations have provided their support to distribute masks, gloves, and therapies to patients. Unfortunately the fundraising activities suffered due to the lockdown, and the main problems were related to social distancing and lack of public campaigns. The institutional relationships have increased during the COVID-19 pandemic and they mainly regarded the participation in legislative interventions. Among the initiatives adopted, our sampled associations affirmed that they would like to maintain the social support provided to patients experienced during the pandemic.Finally we calculated a resiliency score and we discovered that the majority of the sampled associations developed an intermediate level of resiliency and that it is positively correlated with their tenure.ConclusionsOur results provide a fresh view about the role of patient advocacy associations during the pandemic indicate their important role within the NHS.
PP88 Bayesian Joint Models For Cost-Effectiveness Analyses Based On Clustered Participant Data, With Implementation In Stan
Authors: Esser Jonas , Varga Anita , Alili Mohamed El , Van Dongen Johanna , Bosmans Judith 
Published: December 2022

IntroductionCost-effectiveness analyses of empirical participant data are frequently complicated by irregularly distributed and correlated observations, which are not well approximated by normal distributions. Things get even more difficult when observations are clustered within higher level units (for example, hospitals) or the participant (that is, multiple measurements at different timepoints). Therefore, we developed a flexible Bayesian approach to jointly model costs and effects of two competing interventions with a multilevel structure.MethodsOur new model is presented in mathematical form and discussed in detail. We model costs and Quality-Adjusted Life-Years effects through Gamma and Beta distributions, and account for the dependency between costs and effects by adding the effects as a predictor for the costs. We further include hurdle models to account for costs of for the presence of zero costs and perfect health scores.The full model is implemented in the probabilistic programming language Stan. To compare the performance of our Bayesian model to a frequentist approach (linear mixed model combined with bootstrapping), we simulate 1000 datasets consisting of 400 participants and 20 clusters. Performance of both models is assessed in terms of variance, bias and coverage probability with respect to the costs and effects defined in the simulation.ResultsWe ran a preliminary simulation with high intraclass correlation, strong negative correlation for patient-level costs and effects, and positive correlation of cluster effects on both outcomes. The analysis shows that the Bayesian model exhibits a slightly larger bias for estimated costs, but smaller errors and higher coverage probability compared to the frequentist alternative. We will explore different scenarios where we vary the parameters of the simulations and assess whether the results are robust to change.ConclusionsIt is very important that economic evaluations in health care produce precise and reliable results. Our Bayesian approach is able to handle multiple statistical complexities at once and performs better than a comparable frequentist model. Whether this conclusion holds for different simulation scenarios will be explored in further stages of this study.
PP90 Startup And Inclusion Problems In Healthcare Efficiency Studies: A Quantitative And Qualitative Analysis
Authors: Drenth Jennifer , Van Liere-visser Karen , Warmerdam Daniël , Zijp Inge , van Zessen Ruud 
Published: December 2022

IntroductionAging populations and specialized medicine are leading to increasing healthcare costs which are expected to rise in the next decades. The Netherlands Organization for Health Research and Development (ZonMw) funds trials that address the efficiency of healthcare interventions in order to evaluate new and existing interventions. These studies have led to considerable cost savings and increased health outcomes. However, efficiency studies often face setbacks during the start-up and inclusion which limit the available research capacity and postpone the availability of novel findings. Here, we investigate the scope of these problems and identify common causes.MethodsRecords from efficiency research trials funded by ZonMw from 2014-2020 were combined with information provided by project leaders through a survey. The combined dataset was explored through statistical analysis. Next, a subset of 30 selected projects was evaluated qualitatively to gain a better understanding of the possible underlying reasons for the experienced problems.ResultsThe response rate among project leaders was 73 percent (146/201). Data indicate that 61 percent of projects started as planned and 35 percent included the first patient as scheduled. The complexity of setting up a multicenter study and legal procedures like local ethical approval were associated with delays in starting inclusions. In addition, 56 percent of studies had to extend the inclusion period by more than 6 months. Possible reasons that were identified include the limited numbers of patients available, and treatment preferences of the doctor, the patient, or the participating center.ConclusionsOur results indicate that the majority of trials face setbacks and the main reasons include time to procure legal and ethical approval, limited patient numbers, as well as unforeseen treatment preferences. More streamlined procedures regarding approvals could speed up trial initiation, and better knowledge of eligible patients and treatment preferences could lead to more realistic planning. The results and conclusions from this study can be applied by ZonMw and other relevant stakeholders to resolve the identified problems in order to accelerate healthcare efficiency research.
PP92 Should Missing Data Be Multiply Imputed Prior To Longitudinal Linear Mixed-Model Analyses In Trial-Based Economic Evaluations?
Authors: Ben Ângela J , van Dongen Johanna M , Alili Mohamed El , Heymans Martijn W , Twisk Jos W R , MacNeil-Vroomen Janet L , de Wit Maartje , van Dijk Susan E M , Oosterhuis Teddy , Bosmans Judith E 
Published: December 2022

IntroductionFor the analysis of clinical effects, multiple imputation (MI) of missing data was shown to be unnecessary when using longitudinal linear mixed-models (LLM). It remains unclear whether this also applies to cost estimates from trial-based economic evaluations, that are generally right-skewed. Therefore, this study aimed to assess whether MI is required prior to LLM when analyzing longitudinal cost-effectiveness data.MethodsTwo-thousand complete datasets were simulated containing five time points. Incomplete datasets were generated with 10 percent, 25 percent, and 50 percent missing data in costs and effects, assuming a Missing At Random (MAR) mechanism. Statistical performance of six different methodological strategies was compared in terms of empirical bias (EB), root-mean-squared error (RMSE), and coverage rate (CR). Six strategies were compared: (i) LLM (LLM), (ii) MI prior to LLM (MI-LLM), (iii) mean imputation prior to LLM (M-LLM), (iv) complete-case analysis prior to seemingly unrelated regression (CCA-SUR), (v) MI prior to SUR (MI-SUR), and (vi) mean imputation prior to SUR (M-SUR). To evaluate the impact on the probability of cost-effectiveness at different willingness-to-pay [WTPs] thresholds, cost-effectiveness analyses were performed by applying the six strategies to two empirical datasets with 9% and 50% of missing data, respectively.ResultsFor costs and effects, LLM, MI-LLM, and MI-SUR performed better than M-LLM, CCA-SUR, and M-SUR, as indicated by smaller EBs and RMSEs, as well as CRs closer to the nominal levels of 0.95. However, even though LLM, MI-LLM, and MI-SUR performed equally well for effects, MI-LLM and MI-SUR were found to perform better than LLM for costs at 10 percent and 25 percent missing data. At 50 percent missing data, all strategies resulted in relatively high EBs and RMSEs for costs. In both empirical datasets, LLM, MI-LLM, and MI-SUR all resulted in similar probabilities of cost-effectiveness at different WTPs.ConclusionsWhen opting for using LLM for analyzing trial-based economic evaluation data, researchers are advised to multiply impute missing values first. Otherwise, MI-SUR may also be used.