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Introduction/Objective Recent reports suggest that though COVID-19 is predominantly a respiratory pathogen, one of its presenting features can be gastrointestinal symptoms. We hereby present a case of a female with COVID-19 infection whose hospital course was complicated by colonic pseudo-obstruction caused by pseudomembranous colitis resulting in an emergent hemicolectomy. Methods A 59-Year-old female with history of hypertension, diabetes, and breast cancer post mastectomy presented with pneumonia and was confirmed to be COVID-19 positive. She was admitted to the hospital and was treated with Azithromycin for 6 days. Patient developed constipation on day six of hospitalization and started having abdominal pain on day eight with elevated WBC count. Imaging showed distension of cecum and proximal colon. She underwent exploratory laparotomy which revealed a necrotic appearing cecum that was massively dilated and had a serosal tear. These findings prompted emergent hemicolectomy with loop ileostomy. Grossly cecum was black/green, dilated, thin walled with a 5 x 5 cm yellow green raised plaques. Microscopy of the plaques revealed focal erosion of colonic mucosa with overlying acute inflammatory cells, fibrin deposits, mucus, and necrotic epithelial cells consistent with pseudomembranous colitis. Conclusion Review of literature shows no reported cases of intestinal pseudo-obstruction due to pseudomembranous colitis in a COVID-19 patient. Not only this, but there are also only a limited number of case studies of pseudomembranous colitis presenting as intestinal pseudo-obstruction without diarrhea. Though this patient's presentation could be from Clostridium difficile infection secondary to Azithromycin, it is not a common antibiotic to cause this. Also, one of the known causes of pseudomembranous colitis is ischemia. Given that COVID-19 infection is a pro-thrombotic condition, possible ischemia secondary to COVID-19 infection related coagulopathy should also be a consideration.
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Nicknamed "SARS Stock," the event celebrated the end of the severe acute respiratory syndrome 1 (SARS-CoV-1) outbreak2 But Grant Johnson, MLT, team leader of microbiology at The Hospital for Sick Children at the time, was not at the concert. [...]Health Canada approved several in early 2020.3 CJMLS spoke to Johnson and laboratory professionals at another Canadian hospital to learn how incorporating Cepheid's GeneXpert,a popular rapid PCR box testing platform, has affected the work of laboratory professionals and patient care and how they managed issues that arose with it during the COVID-19 pandemic. Available in various sizes ranging from two to 16 modules, the GeneXpert platform can process tests for different indications simultaneously, making "on-demand molecular testing available to everyone with unprecedented speed and ease of use," according to the company's marketing materials.3 Preparation time is about five to seven minutes, and results are available within about 50 minutes.4 For example, the Cepheid GeneXpert Xpert Xpress SARS-CoV-2 assay targets two genome regions on the virus, the envelope and the nucleocapsid. Test results for individual patients confirmed whether they needed to isolate to prevent infecting others or if it was safe for them to visit loved ones, such as those in long-term care facilities with a higher risk of severe disease and mortality from SARS-CoV-2 infection.
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Various reagents and equipment for testing SARS-CoV-2 infections have been developed, particularly rapid molecular tests based on polymerase chain reaction (PCR).We evaluated the analytical performance of four rapid molecular tests for SARS-CoV-2. We used 56 nasopharyngeal swabs from patients with confirmed SARS-CoV-2 infection;36 diagnosed as positive by the Ampdirect™ 2019-nCoV Detection Kit (Shimadzu assay) were considered as true-positive samples.The sensitivity of Cobas® Liat SARS-CoV-2 and Flu A/B (Cobas) was the highest among the four molecular test kits. The limit of detection was 1.49 × 10−2 copies/µL (95% confidence interval [CI]: 1.46×10−2−1.51 × 10−2 copies/µL) for Cobas;1.43 × 10−1 copies/µL (95% CI: 8.01×10−3−2.78 × 10−1 copies/µL) for Xpert® Xpress SARS-CoV-2 test (Xpert);2.00 × 10−1 copies/µL (95% CI: 1.95×10−1-2.05 × 10−1 copies/µL) for FilmArray Respiratory Panel v2.1 (FilmArray);and 3.33 × 10 copies/µL (95% CI: 1.93 × 10–4.72×10 copies/µL) for Smart Gene® SARS-CoV-2 (Smart gene). Cobas also had a high sensitivity (100%) compared with Shimadzu assay. The sensitivities of Xpert, FilmArray, and Smart Gene were 97.2%, 97.2%, and 75.0%, respectively. The specificity of all tests was 100%.In conclusion, the four rapid SARS-CoV-2 molecular test kits have high specificity and sensitivity for detecting SARS-CoV-2. As they are easy to use, they could be a useful method for detecting SARS-CoV-2.
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IntroductionMulti-criteria decision analysis (MCDA) is a useful tool in complex decision-making situations and has been used in medical fields to evaluate treatment options and drug selection. We aimed to provide valuable insights on the use of MCDA in health care through examining the research focus of existing studies, major fields, major applications, most productive authors and countries, and most common journals in the domain using a scientometric and bibliometric analysis.MethodsPublications related to MCDA in health care were identified by searching the Web of Science Core Collection on 14 July 2021. Three bibliometric software programs (VOSviewer, Bibliometrix, and CiteSpace) were used to conduct the analysis.ResultsA total of 410 publications were identified from 196 academic journals (average yearly growth rate of 32% from 1999 to 2021), with 23,637 co-cited references by 871 institutions from 70 countries or regions. The USA was the most productive country (n=80), while the Universiti Pendidikan Sultan Idris (n=16), Université de Montréal (n= 13), and Syreon Research Institute (n=12) were the most productive institutions. The biggest nodes in every cluster of author networks were Aos Alaa Zaidan, Mireille Goetghebeur, and Zoltan Kalo. The top journals in terms of number of articles (n=17) and citations (n=1,673) were Value in Health and the Journal of Medical Systems, respectively. The research hotspots mainly included the analytic hierarchy process (AHP), decision-making, health technology assessment, and healthcare waste management. In the recent literature there was more emphasis on coronavirus disease 2019 (COVID-19) and fuzzy Technique for Order Preference by Similarities to Ideal Solution (TOPSIS). Big data, telemedicine, TOPSIS, and the fuzzy AHP, which are well-developed and important themes, may be the trends in future research.ConclusionsThis study provides a holistic picture of the MCDA-related literature published in health care. MCDA has a broad application in different topic areas and would be helpful for practitioners, researchers, and decision makers working in health care when faced with complex decisions. It can be argued that the door is still open for improving the role of MCDA in health care, both in its technologies and its application.
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IntroductionCataract surgery is the most commonly performed surgical procedure in the UK (approx. 472,000 annually). The suspension of interventions due to the COVID-19 pandemic, has had a devastating impact on patients' access to care. In the UK a complete cessation of elective cataract surgery during the crisis has been an unfortunate reality and encompassed a 14 week hiatus to services in the National Health Service. Patients on prolonged waiting lists may experience negative outcomes during the wait period, including vision loss, increased risk of falls, and ultimately, poorer health-related quality of life (HRQoL). The objective of this research was to estimate the potential societal costs associated with vision-loss related to prolonged waiting times for cataract surgery, as a consequence of COVID-19 in the UK.MethodsIn this analysis, we present estimates relating to two cohorts: a hypothetical cohort of 1,000 cataract surgeries and quarterly estimates of cataract surgeries in the UK. Quarterly estimates (n=122,969) were chosen to reflect a suspension of cataract surgeries for 14 weeks during the COVID-19 crisis. UK cataract surgery numbers were attained from EUROSTAT. Estimates for decreasing visual acuity for those waiting for surgery were attained from the literature, as were the cost estimates associated with cataract-related sight-loss, which were made up of direct, indirect and intangible costs. Five scenarios (at 20% intervals) were simulated for the cost estimates, assuming from 20 percent to 100 percent clearing of waiting lists.ResultsFor cohort 1 (1,000 patients), the societal costs associated patients remaining on waiting list for one year, ranged between GBP 237,765 (EUR 279,533) (20% of patients remain untreated) to GBP 1.18m (EUR 1.39m) (100% remain untreated). For cohort 2 (n=122,969) cost estimates are in the region of GBP 29.23m to GBP 146.18m (EUR 34.36m to EUR 171.73m). Estimates consist of direct (15.6%), indirect (28.7%) and intangible costs (55.6%).ConclusionsCataract surgery is a sight saving procedure and its impact on HRQoL is overwhelmingly positive. Prolonged waiting times for cataract patients due to COVID-19 is likely to be associated with significant societal costs.
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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.
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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.
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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.
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IntroductionThe COVID-19 pandemic has affected thousands of people worldwide. The collapse of health systems led to increased difficulties in accessing health care for people with disabilities. The objective was to define strategies to support the implementation of health care for people with disabilities.MethodsThe protocol for the systematic review was registered on PROSPERO (CRD42021266341). Searches were done in seven databases, using MeSH terms related to COVID-19 and disability, in 2021. We included interventions that addressed health, education and social assistance.ResultsTwenty-nine studies were included. A meta-synthesis identified strategies to assist individuals with disabilities: creation of emergency accommodation and protection programs;flexible work arrangements;cash transfer programs;community participation in planning;establishment of support networks;social assistance even in periods of health emergency;teleconsultation services, telerehabilitation and systems that facilitate the use of digital technologies for telemedicine;inclusive guidelines for computer literacy and learning. The main implementation action was comprehensive health care centered on the needs of people with disabilities, with a focus on training community informants, continuing education of health professionals and caregivers for emergency situations, decentralization of care, identification and elimination of barriers to access.ConclusionsEven though the focus was on telehealth and social assistance, achieving comprehensive healthcare requires a range of interventions that together will support the reduction of inequity faced by people with disabilities.
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IntroductionThe outbreak of the COVID-19 pandemic generated the need to adapt patients' access to health services, given the rapid and exponential increase in demand at all levels of care, making social distancing one of the few weapons available in this fight. In this scenario, telehealth proved to be a fundamental tool in tracking and guiding patients with suspected or confirmed disease. This work presents the demographic profile of the people attended, the most prevalent clinical situations in care and the clinical outcomes of the remote care.MethodsThis was an observational, descriptive, cross-sectional, retrospective study carried out at Unimed Belo Horizonte, a medical work cooperative, from March 2020 to May 2021. We analyzed anonymized data on remote care from electronic medical records provided by the operator, with the remote contacts of these patients being spontaneous.ResultsIn the period evaluated, 380,663 remote calls were made, with a monthly average of 36,888 calls. Of these visits, 59.5% were carried out by women and 40.5% by men. There were, 13,211 (3.5%) consultations with patients aged 0 to 9 years, 19,933 (5.2%) 10 to 19 years, 319,882 (84%) in people aged 20 to 59 years, and 27,633 (7.3%) aged 60 years or older. There were 64,348 (17%) consultations in patients with confirmed COVID-19 and 40,997 (11%) with suspected COVID-19. There were 194,746 (51.2%) consultations due to respiratory complaints and 14% of consultations due to other causes, but whose initial care was due to signs and symptoms suggestive of COVID-19. Of people assisted remotely, 29,734 (7.8%) attended the emergency room within 3 days, while 38,685 (10.2%) sought the emergency room within 14 days. There were 2,846 (0.7%) consultations in the emergency room that resulted in the hospitalization of patients.ConclusionsTelehealth proved to be resolute and an important tool for accessing health services during the pandemic.
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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.
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IntroductionLife expectancy is increasing worldwide. However, during the COVID-19 pandemic, people 100 years or more (centenaries) were challenged by a potentially fatal disease. We evaluated the outcome of centenaries hospitalized due to COVID-19 in a private healthcare system of Belo Horizonte/Brazil (Unimed-BH).MethodsAdministrative data were collected from the hospital database. Patients were included if they had a severe adult respiratory syndrome due to coronavirus type 2 (SARS-CoV-2) ribonucleic acid identified by quantitative real-time reverse transcriptase polymerase chain reaction (RT-qPCR) or by the International Code of Disease-10th review (ICD-10) hospitalization codes U07.1, B34.2, or B97.2.ResultsFrom March 1 2020 to October 31 2021, 316.4 ± 12.9 centenaries/month were registered. Eighteen hospitalizations due to COVID-19 were identified. Median age was 101.8 years (inter-quartile range [IQR]:100.7,103.0). Most patients were female (83%). There was a median of 6.0 morbidities per patient (IQR:5.3,7.8), range 2-12 morbidities, among 71 possible morbidities. The most described morbidities were systemic arterial hypertension (94%), dementia (61%), and congestive heart failure (61%). Median length of hospitalization was 6.5 days (IQR:3.3,8.0). No patient was dialyzed. Seven (39%) patients died during hospitalization, of whom 3 (17%) were admitted to the Intensive Care Unit and 2 (11%) were oxygenated by invasive mechanical ventilation. No other patients were admitted to the Intensive Care Unit or invasively mechanically ventilated.ConclusionsAlthough the hospitalization rate was low, the mortality rate during hospitalization was high among centenaries. Further research is required to evaluate the actual risks of centenaries to be infected by SARS-CoV-2 and the subsequent outcomes.
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IntroductionWe aimed to map and synthesize the available evidence on neuron-specific biomarkers related to COVID-19.MethodsA systematic review and qualitative evidence mapping synthesis was performed (PROSPERO-CRD42021266995). Searches were conducted in PubMed and Scopus, and complemented by manual search (July 2021). We included observational studies of any design assessing neurological biomarkers in adult patients (>18 years;with or without neurological comorbidities) diagnosed with COVID-19. Methodological quality of nonrandomized studies (case-control, cohorts) was assessed using the Newcastle-Ottawa Scale.ResultsOverall, 14 studies (n=485 patients) conducted in Sweden (n=4 articles, 28.5%), Germany (n=3;21.4%), USA (n=3;21.4%), Canada, France, Italy and Norway (n=1 study each) were included. The most reported neurological symptoms (n=13 studies, 92.8%) were headache, confusion, general weakness, loss of smell/taste, cognitive impairments and behavioral changes. Prevalent neurological conditions included encephalopathies, neuropathies, myopathies, and delirium;most critical cases presented cerebrovascular events (n=4 studies, 28.5%). Hypertension, diabetes, obesity, dyslipidemia, and chronic lung disease were the most reported comorbidities. Eight different neuron-specific biomarkers were found in primary studies: neurofilament-light chain – NfL (n=10 studies;71.4%), glial fibrillary acidic-protein – GFAp (n=5;35.7%), tau protein (n=5;35.7%), neurofilament-heavy chain – NfH, S100B protein, ubiquitin C-terminal hydrolase L1 - UCH-L1, neuron-specific enolase and beta protein-amyloid – Aβ (n=1 study each). These biomarkers were found both in cerebrospinal fluid and blood/plasma samples even without an evident cytokine storm. In patients with COVID-19, NfL and GFAp can act as sensitive indicators of neuroaxonal and astrocytic damages, respectively. Increased levels of NfL were significantly associated with severe COVID-19, unconsciousness and longer stay in the intensive care unit (p<0.05). Studies had an overall poor to moderate methodological quality.ConclusionsWe identified eight neuron-specific biomarkers that should be further studied as prognostic factors of COVID-19. These findings can also guide the development of targeted therapies against SARS-CoV-2. Additional well-designed clinical trials are needed to strengthen this evidence and help understand the mechanisms of neurological symptoms and sequelae after COVID-19 infection.
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IntroductionWe aimed to develop and validate machine learning (ML) -based algorithms to predict COVID-19 diagnosis as well as to identify new biomarkers associated with the disease.MethodsInitially, 96 blood samples of patients diagnosed with COVID-19 (Thaizhou Hospital, China) were analyzed through liquid chromatography coupled to mass spectrometry. Samples of patients presenting other pneumonias or severe acute respiratory syndrome, but with negative RT-PCR for SARS-CoV-2, were used as positive controls. Samples from healthy volunteers were used as negative controls. The final database included around 1000 metabolites. Exploratory analyses for the development of ML-based models using principal component analysis (PCA) were performed. Leverage plot versus studentized residuals method was used to detect outliers. Three supervised ML-based models were developed: discriminant analysis by partial least squares (PLS-DA), artificial neural networks discriminant analysis (ANNDA) and k-nearest neighbors (KNN). Samples for the training (70%) and testing sets (30%) were randomly selected using the Kenrad Stone algorithm. Models' performance was evaluated considering accuracy, sensitivity and specificity. Analyses were conducted in SOLO (Eigenvector-Research).ResultsThe PCA model was able to distinguish the three classes of patients' samples (positive for COVID-19, negative controls, positive controls) with an overall accumulated variance of 94.27 percent. The PLS-DA model presented the best performance (accuracy, sensitivity, and specificity of 93%, 98% and 88%, respectively). Increased levels of the biomarkers uridine (linked to glucose homeostasis, lipid, and amino acid metabolisms), 4-hydroxyphenylacetoylcarnitine (metabolite from the tyrosine metabolism;probably associated with anorexia) and ribothymidine (resulting from oral and fecal microbiota alterations) were significantly associated with COVID-19.ConclusionsThree different and updated ML-based algorithms were developed to predict COVID-19 diagnosis;PLS-DA led to the most accurate results. High levels of some metabolites were found as potentially predictors of the disease. These biomarkers should be further evaluated as potential therapeutic targets in well-designed clinical trials. These ML-based models can help the early diagnosis of COVID-19 and guide the development of tailored interventions.
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IntroductionThe National Institute for Health and Care Excellence (NICE) intends to automate the way it monitors the uptake, impact, and value of its guidance. Traditionally this has been done by developing impact reports, long documents that, while well received, are time consuming to develop and can quickly become outdated.MethodsWe focused on a novel topic that would benefit from new data sources to examine its impact: a rapid guideline for managing the long-term effects of coronavirus disease 2019 (COVID-19). We shortlisted "measurable” recommendations within the guideline that were likely to be captured in data collections. We then reviewed available data sources that included relevant up-to-date data. Finally, we explored what existing methods were available to NICE for automating impact reporting.ResultsFor long COVID-19 we accessed OpenSAFELY, a secure, transparent software platform for primary care COVID-19 data that was developed in response to the pandemic. This captured data on the management of long COVID-19 in primary care as well as onward referral to specialist clinics. In addition, we accessed data from the CVD-COVID-UK/COVID-IMPACT Consortium, which links general practice records with primary care dispensing data. This enabled us to analyze the impact of the pandemic on the prescribing and dispensing of cardiovascular disease medications. Working with our digital team we developed an automated impact reporting dashboard using Google's data studio. This enabled different views of the data, for example by region or socioeconomic status, to be presented in an automated way.ConclusionsAutomating the impact reporting of NICE guidance provides up-to-date information on its value to the health system. While we were able to collect new sources of data and automate some aspects of how these were viewed, full automation requires several enablers. These include an application programming interface between the data sources and NICE, and ensuring that NICE guidance is computer readable so that its measurement is practical in healthcare systems.
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IntroductionTelemedicine strategies have been broadly introducing in health services during the COVID-19 pandemic, including in care of neurological diseases.MethodsA rapid realist review was conducted using EUnetHTAs Core Model 3.0 and GRADE evidence to decision frameworks were used as frameworks to describe the ethical, legal, organizational, social and patient aspects (ELSI+) related to the use of teleneurology (TN) A scoping multistakeholder meeting helped defined the scope and research questions of the assessment. Patient representatives, clinicians, scientific society representatives with relevant experience in TN were invited and participated. Industry representatives were also present. Systematic searches for ethical, legal, organizational, social and patients related aspects were conducted. Additional manual searches contributed to contextualize these dimensions in the Spanish context. A narrative synthesis was undertaken.ResultsMain results of the assessment of the ELSI+ aspects of TN were described. TN applications are diverse depending on the condition, objective of care and technology used. The implementation of TN lacks specific legal frameworks which implies legal uncertainty. TN may increase geographical accessibility to neurological care in remote areas and by reducing difficult commuting to specialized care centers. Nevertheless, accessibility is challenged by reduced access to technology, the digital divide, lack of health literacy or technologies not adapted to functional diversity. Therefore, equity is not guaranteed if it is offered as a non-voluntary basis or with no support. TN tends to be accepted by patients and carers if it has enough quality, saves travelling time and costs and does not dehumanize care as it is perceived as more flexible and convenient. Quality of TN needs an interdisciplinary team with skills to coordinate organizational aspects of the implementation which include among others, the planification of the support to patients and carers before, during and after the consultation. Health professionals may also need to learn adapted communicational and technological skills.ConclusionsThe implementation of TN poses many ethical, legal, organizational, social or patient-centered challenges.
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IntroductionConstantly rising costs of pharmaceuticals and biologics spurred a debate in recent years leading to increasingly persistent public calls to overhaul the existing system of pricing and distributing health technologies. The COVID-19 pandemic exposed the controversies of the current model of access to health commodities in all evidence when the existing discrepancy between the global supply and the global demand in health technology can be viewed as an illustration of a conflict between the neoliberal free market ideal of health innovation genesis and ownership and the original democratic principles of what would now be called sustainable human development.MethodsPresented here is an integrative literature review of over 265 publications in peer-reviewed journals on Pubmed and Web of Science, academic and "grey” literature, mainly publicism, published in English. We reviewed and analyzed included literature for the purposes of identifying leading ideas with regards to ethical frameworks for evaluating or referencing value for pricing health commodities.ResultsSeven drug pricing models were analyzed in terms of them satisfying the three most common criteria of price adequacy – its fairness (viewed from the point of view of main schools of ethical thought), accountability-for-reasonableness (including transparency of decisions, relevance, existing mechanisms of revisions and governance to ensure compliance), and price functionality. One of the central ideas under controversy is value, its relative character for different contexts due to the high weight of the willingness-to-pay in the value-based health technology assessment (HTA) decisions and the relative value of money, and the attempts to quantify value in a universal way for institutions, patients, and originators.ConclusionsWhile the review scored the pricing models on their "public fairness” with volume-based rather than value-based pricing models leading the rating, the main conclusion of the review is that the main meaningful divide is between value creation and value extraction when pricing health innovation.
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IntroductionThis study aims to (i) describe the (evidence-based) reimbursement process of hospital individual services, (ii) evaluate the accordance between evidence-based recommendations and reimbursement decision of individual services and (iii) elaborate potential aspects that play a role in the decision-making process in Austria.MethodsThe reimbursement process is described based on selected relevant sources such as official documents. Evidence-based recommendations and subsequent reimbursement decisions for the annual maintenance of the hospital individual service catalogue in Austria between 2008 and 2020 were analyzed using a mixed methods approach, encompassing descriptive statistics and a focus group with Austrian decisionmakers.ResultsOne hundred and eighteen evidence-based recommendations were analyzed. There were 93 (78.8%) negative and 25 (21.2%) positive evidence-based recommendations. In total, 107 out of 118 evidence-based recommendations (90.1%) did not lead to a deviating reimbursement decision. We identified six aspects that may have played a role in the decision-making process for the annual maintenance of the hospital individual service catalogue, with clinical evidence being the most notable. Further aspects included quality assurance/organizational aspects (i.e., structural quality assurance), costs (if comparable to already existing medical services, not: cost-effectiveness), procedural aspects (e.g., if certain criteria for adoption have not been met formally through the proposals), "other countries” (i.e., taking into account how other countries decided) and situational aspects (such as the COVID-19 pandemic).ConclusionsThere is good accordance between evidence-based recommendations and reimbursement decisions regarding hospital individual services in Austria. Beyond clinical evidence, organizational aspects seem to be considered often with regard to quality assurance but costs do not appear to play a major role. The Austrian system has mechanisms in place that can restrict widespread adoption of novel hospital individual services with uncertain clinical benefits. Future studies could investigate how well these mechanisms work and how they compare to other health systems in Europe.
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IntroductionThe European Network for Health Technology Assessment (EUnetHTA) was a voluntary cross-border initiative on HTA harmonization established by European Commission in 2005. Between 2016-2021, EUnetHTA completed 56 Joint Assessments (28 drugs;28 other technologies) including 14 reviews of COVID treatments.MethodsWe conducted a review of the 14 EUnetHTA joint assessment reports of drugs in non-COVID 19 indications. We cross-referenced recommendations with national guidance in 30 member countries (including UK) and conducted an analysis of time to national assessment, choice of comparator, direct reference to EUnetHTA assessment, and time to reimbursement decision.ResultsSix products in oncology, 2 in endocrine and metabolic diseases, 2 in infectious and parasitic diseases, and cardiovascular, digestive system, eye disorders and central nervous system (one each) were identified. On average, EUnetHTA published its recommendation 52 days after market authorization for oncology products and 33 days for non- oncology products. EUnetHTA recommendations considered on average 4 comparators (range 1-8) as part of the assessment. All of the 6 oncology products have been assessed by national HTA bodies, however uptake was low with an average of 5 reports referencing the EUnetHTA report. Similarly for the non-oncology products assessed only 3 of 30 HTA bodies cite the EUnetHTA report. Citing HTA bodies were: AETSA (Spain), HAS (France), INFARMED (Portugal), NoMA (Norway), and TLV (Sweden). There was no clear reduction in the time to reimbursement for these products in these markets.ConclusionsAccording to EUnetHTA, there has been an increased use and dissemination of joint assessment reports since 2016. Our analysis shows that the level of implementation across countries is heterogeneous despite publication of the EUnetHTA reports shortly after market authorization. The future the EU HTA will depend on the timeliness, rigor and transparency of joint clinical assessment reports and improved uptake of these reports at a national level.
ABSTRACT
IntroductionCoronavirus disease 2019 (COVID-19) is a contagious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Symptoms of COVID-19 are variable, but often include fever, cough, headache, fatigue, breathing difficulties, and loss of smell and taste. Symptoms may begin one to fourteen days after exposure to the virus. COVID-19 transmits when people breathe in air contaminated by droplets and small airborne particles containing the virus. The present analysis aims to define the cost-effectiveness profile of the anti-COVID vaccination campaign in the Italian healthcare setting.MethodsThe analysis was based on the collection and analysis of data regarding the number of hospitalizations (ordinary regime and intensive care) and infections recorded by the Italian Ministry of Health in vaccinated and unvaccinated patient cohorts. The acquisition costs of the available vaccine alternatives were considered as well as the cost of the personnel involved in the vaccination campaign. The reduction in hospitalizations was considered as a measure of effectiveness. We have compared the current scenario of campaign vaccination versus a scenario in which the total of the eligible population would be vaccinated. Results are reported in terms of Incremental Cost Effectiveness Ratio (ICER). Deterministic and probabilistic sensitivity analyses were carried out in order to test the robustness of the results.ResultsThe vaccination campaign allowed for savings amounting to EUR 9,398,012.10 (EUR 60,499,053.25 vs EUR 69,897,065.35) and 6,647 hospitalizations avoided (715 and 5,932 in the intensive care and ordinary regimen, respectively), thus resulting a dominant strategy as compared with the alternative (no vaccination). As the cost-effectiveness profile of the campaign improves, we should consider the period (May-July 2021), during which the daily threshold of 500,000 doses administered on a national basis was consistently exceeded.ConclusionsThe analysis underlined how the vaccination campaign represents a cost-saving alternative in the Italian healthcare setting.