Cancer 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.

We 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.

From 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).

Half 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.

The use of most recent Transcatheter aortic valve implants (TAVI) in the treatment of symptomatic severe aortic stenosis (SAS) is evolving with expanded indications from inoperable/high-risk to intermediate and low risk patients. Consequently, TAVI outcomes must be monitored to highlight its value under real-world conditions. Our aim was to prospectively evaluate TAVI (SAPIEN 3) outcomes in terms of patient's health-related quality of life (HRQoL), clinical outcomes, and healthcare resource utilization (HRU).

An observational prospective study including all consecutive patients with SAS undergoing a transcatheter valve implantation with Edwards SAPIEN 3 valve (transfemoral access) was conducted in full accordance with clinical guidelines from the European Society of Cardiology. Patients were evaluated before the intervention (baseline), at discharge, and after one, six and twelve months from the implant. A thoughtful and systematic evaluation of patients’ HRQoL (EQ-5D 5L, the Short Form-36 Health Survey -SF-36- and the Kansas City Cardiomyopathy Questionnaire -KCCQ-), clinical endpoints (that is, cardiovascular mortality, and rates of stroke, major bleeding, myocardial infarction, and re-hospitalization), echocardiographic measurements, and HRU (that is, Length of stay-LOS- in ward/intensive care unit -ICU-) was implemented. Multivariate regression models were applied to test outcomes while controlling key risk factors (that is, patient’ severity at baseline).

A total of seventy-six patients (fifty percent female, fifty-five percent of intermediate-high risk) with a mean age of 82.1 ± 4.78 years were included. Implant success was 97.34% and cardiovascular death was 2.6% at one year. Significant reductions in mean and maximum gradients were achieved and maintained during follow-up. Mean LOS in ward (5.2 ± 4.0days) and ICU (0.22 ± 0.64 days) were low. Statistically significant improvements were detected in the KCCQ overall summary scores, EQ-5D, and SF-36 (Physical component summary) - all adjusted - p < 0.05 - after the intervention.

TAVI represents a safe and effective innovation for SAS with clinical benefits translated into significant improvements in terms of HRQoL. Besides, the low HRU provides new insights for health-economic modelling and the optimization of limited resources of special importance under current pandemic situation.

An 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.

As 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.

We 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.

There 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.

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.

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.

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).

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.

Music therapy (MT) is a complementary creative arts treatment aimed at maintaining, restoring, and furthering physical, emotional, and mental health. This systematic review aimed to assess the effectiveness of MT for the treatment of autism spectrum disorder, dementia, depression, insomnia, and schizophrenia. In addition, the MT methods used for these indications were analyzed.

For this update of five Cochrane reviews, four databases (Medline, Embase, The Cochrane Library, and PsycINFO) were systematically searched for studies published from 2013 to 2020. Two review authors independently performed the study selection and data extraction. The methodological quality of the included trials was assessed using the Risk of Bias in Non-randomised Studies - of Interventions (ROBINS-I) tool and the Cochrane Risk of Bias tool for randomized controlled trials.

Ten RCTs (1,248 patients) met the inclusion criteria. For schizophrenia, no study could be included. MT improved the following: behavior, social communication, and the parent-child relationship in patients with autism; mood for patients with depression; and sleep quality for patients with insomnia. In patients with dementia, MT enhanced mood, behavior (severe disease stage), and cognitive function, whereas cognition was unchanged. Memory was improved only in the mild disease stage. None of the studies observed any significant long-term effects of MT in these patient groups. Both active (playing music) and receptive (listening to music) methods were used for dementia, whereas active methods were applied for autism spectrum disorder and depression. For insomnia, only receptive methods were used.

The findings of this update of reviews provides evidence that MT may help patients diagnosed with an autism spectrum disorder, dementia, depression, insomnia, or schizophrenia. It is crucial to focus on patient-related evidence-based health care. MT improves physical, psychological, and social aspects, but more research investigating the long-term effects of MT in these patient groups is needed as it is crucial to know how long the effects of MT last.

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).

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.

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.

RCRs can be a means of providing timely and continuous policy support, but they require a high level of coordinated effort.

Health technology reassessment (HTR) is a structured evidence-based assessment of an existing technology in comparison to its alternatives. The process results in the following four outputs: (i) increased use; (ii) decreased use; (iii) no change; or (iv) de-adoption. However, implementing these outputs remains a challenge. Knowledge translation (KT) can be applied to implement findings from the HTR process. This study sought to identify which characteristics of KT theories, models, and frameworks (TMFs) could be useful, specifically for decreasing the use of or de-adopting a technology.

A qualitative descriptive approach was used to ascertain the perspectives of international KT and HTR experts on the characteristics of KT TMFs for decreasing the use of or de-adopting a technology. One-to-one semi-structured interviews were conducted. Interviews were audio recorded and transcribed verbatim. Themes and sub-themes were deduced from the data through framework analysis using the following five distinctive steps: familiarization; identifying an analytic framework; indexing; charting; and mapping and interpretation. Themes and sub-themes were also mapped to existing KT TMFs.

Thirteen experts participated. The following three themes emerged as ideal characteristics of a KT TMF: (i) principles foundational for HTR: evidence-based, high usability, patient-centered, and ability to apply to micro, meso, and macro levels; (ii) levers of change: characterized as positive, neutral, or negative influences for changing behavior; and (iii) steps for knowledge to action: build the case for HTR, adapt research knowledge, assess context, select, tailor, and implement interventions, and assess impact. The Consolidated Framework for Implementation Research had the greatest number of ideal characteristics.

Application of KT TMFs to the HTR process has not been clearly established. This is the first study to provide an understanding of characteristics within KT TMFs that could be considered by users undertaking projects to decrease or de-adopt technologies. Characteristics to be considered within a KT TMF for implementing HTR outputs were identified. Consideration of these characteristics may guide users in choosing which KT TMF(s) to use when undertaking HTR projects.

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.

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).

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.

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.

To facilitate implementation of new health technology assessment (HTA) methods, it is crucial to engage stakeholders. A technically good system may be brought to its knees if the intended users are not willing or able to use it. Therefore, based on these considerations, we aimed to identify relevant aspects of change models and investigated four potentially useful change models in the context of HTA. The four models were: adaptive space; midstream modulation; developmental evaluation; and knowledge brokering.

A narrative literature review was conducted to gather information into a readable and usable format. PubMed and Google Scholar were searched for relevant literature on change management and stakeholder engagement within HTA. Additionally, grey literature was selected after consulting an implementation specialist to gather more information on the background of the change management models.

Several enabling factors for successful stakeholder engagement were found, including attention to branding of the coproduction, facilitation/personal safety, and data or indicators to inform activities. Four change methods were described from the enabling factors identified. There was no “perfect model” for our aim, but all models involved relevant aspects to engage stakeholders. Notably, all models paid attention to the project management factor, whereas none of the models paid explicit attention to the branding of the coproduction factor.

Change management is a complex and elaborate field in which many factors play a role. Stakeholder engagement is a factor that might be influenced by project leaders within international projects such as the European Union's Next Generation Health Technology Assessment (HTx). To improve stakeholder engagement in modernizing HTA, it is important to keep paying attention to project management, relationships, and how to facilitate fora and meetings to improve mutual understanding. Two factors to pay more attention to are branding of the coproduction and consideration of formal structures.

The use of inconsistent and outdated information may significantly compromise healthcare decision-making. We aimed to assess the extent of lag times in the publication and indexing of network meta-analyses (NMAs).

Searches for NMAs on drug interventions were performed in PubMed (May 2020). Lag times were measured as the time between the last systematic search and the date of the article's submission, acceptance, online publication, indexing, and Medical Subject Heading (MeSH) allocation. Correlations between lag times and time trends were calculated by means of Spearman's rank correlation coefficient. Time-to-event analyses were performed considering independent variables such as geographical origin, journal impact factor, Scopus CiteScore, and open access status.

We included 1,245 NMAs. The median time from last search to article submission and publication was 6.8 months and 11.6 months, respectively. Only five percent of authors updated their literature searches after submission. There was a very slight decreasing historical trend for acceptance (r =−0.087; p = 0.01), online publication (r =−0.08; p = 0.008), and indexing lag times (r =−0.080; p = 0.007). Journal impact factor influenced the MeSH allocation process (log-rank p = 0.02). Slight differences were observed for acceptance, online publication, and indexing lag times when comparing open access and subscription journals.

Authors need to update their literature searches before submission to reduce evidence production time. Peer reviewers and editors should ensure that authors comply with NMA standards and encourage the development of living meta-analyses.

Artificial intelligence (AI) and innovative technology offer opportunities for enhanced health care during the COVID-19 pandemic. Populations living in low-income countries do not have access to reverse transcription polymerase chain reaction (RT-PCR) testing for COVID-19 and, thus, depend on the scarce resources of their health system. In this context, an automated screening system for COVID-19 based on AI for a telemedicine platform could be directed towards alleviating the current lack of trained radiologists who can interpret computed tomography images at countryside hospitals.

This descriptive study was carried out in Paraguay by the Telemedicine Unit of the Ministry of Public Health and Social Welfare in collaboration with the Department of Biomedical Engineering and Imaging of the Health Science Research Institute and the University of the Basque Country. The utility of the screening system for COVID-19 was analyzed by dividing the results from two tailored AI systems implemented in 14 public hospitals into four likelihood levels for COVID-19.

Between March and October 2020, 911 COVID-19 diagnoses were performed in 14 regional hospitals (62.6% were men and 37.4% were women). The average age of the patients diagnosed with COVID-19 was 50.7 years; 59.1% were aged 19 to 59 years. The two AI systems used have different background information for detecting COVID-19. The most common findings were severe pneumonia and bilateral pneumonia with pleural effusions. The role of computed tomography was to find lesions and evaluate the effects of treatment. The sensitivity of AI for detecting COVID-19 was 93%.

AI technology could help in developing a screening system for COVID-19 and other respiratory pathologies. It could speed up medical imaging diagnosis at regional hospitals for patients with suspected infection during the COVID-19 pandemic and rationalize scarce RT-PCR and specialized human resources in low-income countries. These results must be contextualized with the local or regional epidemiological profile before widespread implementation.

About 70 percent of metastatic breast, lung, and prostate cancers affect the bones. When this phase of the disease affects the spine, the mobility and quality of life of patients are severely impaired. Radiofrequency ablation (RFA) has become a feasible option in the palliative treatment of vertebral metastases due to its minimal invasiveness and short procedure time. This health technology assessment report aimed to identify, evaluate, and synthesize evidence on the safety, effectiveness, and cost effectiveness of RFA for vertebral metastases.

A systematic search was conducted to identify literature published from December 2016 to July 2019 in the following databases: Medline, Embase, the Cochrane Library, and the Centre for Reviews and Dissemination. Systematic reviews, randomized and non-randomized controlled trials, and case series studies evaluating the efficacy and safety of RFA in patients with vertebral metastases were included.

Sixteen studies were included: two systematic reviews, 13 case series studies, and one comparative study. None of the systematic reviews identified any randomized controlled trials. Of the 14 included primary studies, 10 evaluated RFA in combination with vertebroplasty, three evaluated RFA in combination with kyphoplasty, and one study evaluated a combination of RFA and radiation therapy. In all cases, the evaluated patients had different types of cancer (e.g., breast, lung, or liver). The follow-up periods varied between the studies from one day to 12 months. The most commonly used RFA devices were the STAR™ Tumour Ablation System (Merit Medical Systems) and the OsteoCool™ Radiofrequency Ablation System (Medtronic).

RFA reduces pain, improves functional capacity, and provides greater local control of disease, potentially giving patients a higher quality of life, even in the context of metastatic disease. Although there is evidence on the safety and efficacy of this technology for the palliative treatment of vertebral metastases, more studies with higher methodological quality are needed. There were no studies available on the cost effectiveness of RFA for this indication.

Network meta-analysis (NMA) is a key methodology for comparing the effectiveness of multiple interventions or treatments simultaneously. This project aimed to ascertain current methods and visualizations for treatment ranking within an NMA framework and to subsequently develop a novel graphic within MetaInsight (an interactive NMA web application), to aid clinicians and stakeholders when making decisions regarding the “best” intervention(s) for their patient(s).

Current literature on the methodology or visualization of treatment ranking published in the last 10 years was collated and studied. Based on the literature, a novel graphical visualization was developed using RShiny (RStudio, PBC) and integrated within MetaInsight, which is currently hosted on shinyapps.io.

Bayesian analyses produce rank probabilities from which mean or median rank and surface under the cumulative ranking curve can be calculated. For frequentist analyses the p-value is available. The simpler methods may be easier to interpret, but they are often more unstable and do not encompass the whole analysis (and vice versa). To aid interpretation and facilitate sensitivity analysis, an interactive graphic was developed that presents rankings alongside treatment effect and study quality results.

Treatment ranking is useful, but the results should be interpreted cautiously, and the visualization should be transparent and all-encompassing. A ‘living’ version of MetaInsight, with treatment ranking, would allow interested parties to follow the evidence base as it grows.

The experience of implementing a hospital-based health technology assessment (HB-HTA) system in Kazakhstan is currently represented by only one organization, an independent HB-HTA unit established in 2015 in the Medical Center Hospital of the President's Affairs Administration (the Hospital). Despite the demonstrated positive experience of the Hospital, the widespread implementation of the HB-HTA system in Kazakhstan has experienced some barriers that must be considered before further development can occur.

To determine the barriers to developing and implementing HB-HTA in Kazakhstani hospitals, data from the Hospital's experience were obtained through a survey of Kazakhstan hospitals, conducted on behalf of the Ministry of Health Care. An official response was received from 29 hospitals. During the survey and discussions with hospital staff using the “brainstorming” method, several barriers to the development of HB-HTA in Kazakhstan were identified.

Barriers at the system level included the lack of monitoring of the HB-HTA system at the national and regional levels and a lack of methodological support. Organizational barriers included a critically small number of HTA experts and the need for additional logistical support and funding from hospitals. The subjective factors we attributed to the rejection of the HB-HTA system by hospital management were the underestimation of lost profits and that HTA is a tool for promoting a transparent and open system for making managerial decisions.

Despite some barriers, the development of HB-HTA in Kazakhstan is a promising area. The heads of key hospitals in Kazakhstan demonstrated a readiness and understanding of the need to use the principles of health technology assessment and clinical and economic analysis to promote the active transfer and implementation of innovative medical technologies.

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.

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.

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.

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.

Interventional procedures often use iodinated contrast media (ICM) to visualize the area of interest. However, the use of ICM can cause contrast-induced nephropathy (CIN), which is a frequent complication after catheterization and is associated with morbidity and mortality. CIN is also a common complication in patients with pre-existing chronic kidney disease, diabetes, and heart failure. The purpose of this analysis was to compare carbon dioxide (CO2) with conventional contrast agents.

To assess the clinical effectiveness of CO2 in preventing CIN, a systematic review of relevant literature, including international guidelines, from the Medline database was conducted. Imaging of the chest, aorta, coronary arteries, and cerebral circulation with CO2 is limited, so effectiveness was determined in the field of renal and peripheral artery angioplasty. The effect on intervention cost was the main outcome.

Use of CO2 generally reduced renal toxicity and anaphylactic reaction, but the benefits remain controversial. Angiography with CO2 is reasonable when image accuracy is not crucial due to its low informative value. Strategies for preventing acute kidney injury demonstrated the effectiveness of sodium chloride administration before and after the procedure. Additionally, the absence of risk factors for kidney disease significantly reduced the risk of impaired renal function.

Although CO2 is one of the alternative methods for visualization, it is not pivotal in preventing CIN, even though the manufacturers recommend CO2 as the preferred contrast agent in patients with renal insufficiency who are allergic to ICM. The economic indicators for the use of CO2 are similar to traditional visualization methods.

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.

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.

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%.

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.

Lung 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.

We 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.

Three 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.

The 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.

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.

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.

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.

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.

Health care for patients with chronic pathologies was scarce and limited worldwide during the COVID-19 pandemic. The challenge for clinical and biomedical engineers is to develop a bridging system to maintain the basic health services for chronic pathologies. Populations living in low-income countries did not have access to basic health services during the pandemic and depended on the scarce resources of their emergency health system. There were also equity issues between urban and rural populations. In this context, telemedicine tools should be directed toward maintaining the basic health services for patients with chronic pathologies. This study evaluated the results of a telemedicine system in remote public hospitals in Paraguay to show how health care for patients with chronic pathologies has been maintained by providing access to tertiary level diagnostic services by specialists.

This descriptive study evaluated the results of using telemedicine between 2014 and 2020 for diagnosis in remote public hospitals to bridge the gap in providing basic health services for patients with chronic pathologies during the COVID-19 pandemic.

A total of 620,289 telediagnoses were performed in 67 hospitals. The 399,806 electrocardiogram diagnoses performed in 61 hospitals were normal (62%) or showed unspecified arrhythmias (13%) and sinus bradycardia (10%). The 207,597 teletomography tests performed in 12 hospitals were performed on the head because of motorcycle accidents and cerebrovascular diseases (54%), on the chest (14%), and other anatomical regions. The 12,867 electroencephalograms performed in 19 hospitals were for the antecedents of seizure (54%), evolutionary controls (14%), and headache (12%). The 19 ultrasound studies corresponded to prenatal controls.

Although the telemedicine tool implemented in public health to bridge the gap in basic health services for patients with chronic pathologies during the COVID-19 pandemic offered better equity in the provision of services in remote locations, a widespread use assessment should be undertaken before this tool is adopted.