In this paper, we argue that understanding and addressing the problem of poor-quality medical products requires a more interdisciplinary approach than has been evident to date. While prospective studies based on rigorous standardized methodologies are the gold standard for measuring the prevalence of poor-quality medical products and understanding their distribution nationally and internationally, they should be complemented by social science research to unpack the complex set of social, economic, and governance factors that underlie these patterns. In the following sections, we discuss specific examples of prospective quality surveys and of social science studies, highlighting the value of cross-sector partnerships in driving high-quality, policy-relevant research in this area. 相似文献
Management of colorectal cancer (CRC) was severely affected by the changes implemented during the pandemic, and this resulted in delayed elective presentation, increased emergency presentation, reduced screening and delayed definitive therapy. This review was conducted to analyze the impact of the coronavirus disease 2019 (COVID-19) pandemic on management of CRC and to identify the changes made in order to adapt to the pandemic. We performed a literature search in PubMed, Medline, Index Medicus, EMBASE, SCOPUS, Reference Citation Analysis (https://www.referencecitationanalysis.com/) and Google Scholar using the following keywords in various combinations: Colorectal cancer, elective surgery, emergency surgery, stage upgrading, screening, surveillance and the COVID-19 pandemic. Only studies published in English were included. To curtail the spread of COVID-19 infection, there were modifications made in the management of CRC. Screening was limited to high risk individuals, and the screening tests of choice during the pandemic were fecal occult blood test, fecal immunochemical test and stool DNA testing. The use of capsule colonoscopy and open access colonoscopy was also encouraged. Blood-based tests like serum methylated septin 9 were also encouraged for screening of CRC during the pandemic. The presentation of CRC was also affected by the pandemic with more patients presenting with emergencies like obstruction and perforation. Stage migration was also observed during the pandemic with more patients presenting with more advanced tumors. The operative therapy of CRC was altered by the pandemic as more emergencies surgeries were done, which may require exteriorization by stoma. This was to reduce the morbidity associated with anastomosis and encourage early discharge from the hospital. There was also an initial reduction in laparoscopic surgical procedures due to the fear of aerosols and COVID-19 infection. As we gradually come out of the pandemic, we should remember the lessons learned and continue to apply them even after the pandemic passes. 相似文献
IntroductionEndoscopic surveillance guidelines for patients with repaired esophageal atresia (EA) rely primarily on expert opinion. Prior to embarking on a prospective EA surveillance registry, we sought to understand EA surveillance practices within the Eastern Pediatric Surgery Network (EPSN).MethodsAn anonymous, 23-question Qualtrics survey was emailed to 181 physicians (surgeons and gastroenterologists) at 19 member institutions. Likert scale questions gauged agreement with international EA surveillance guideline-derived statements. Multiple-choice questions assessed individual and institutional practices.ResultsThe response rate was 77%. Most respondents (80%) strongly agree or agree that EA surveillance endoscopy should follow a set schedule, while only 36% claimed to perform routine upper GI endoscopy regardless of symptoms. Many institutions (77%) have an aerodigestive clinic, even if some lack a multi-disciplinary EA team. Most physicians (72%) expressed strong interest in helping develop evidence-based guidelines.ConclusionsOur survey reveals physician agreement with current guidelines but weak adherence. Surveillance methods vary greatly, underscoring the lack of evidence-based data to guide EA care. Aerodigestive clinics may help implement surveillance schedules. Respondents support evidence-based protocols, which bodes well for care standardization. Results will inform the first multi-institutional EA databases in the United States (US), which will be essential for evidence-based care.Level of EvidenceThis is a prognosis study with level 4 evidence. 相似文献
PurposeSurface-guided radiotherapy is useful for the pre-positioning and monitoring of radiotherapy. The purpose of this study was to investigate the impact of surface guidance on the repeatability of patient localization and to estimate the specific point at which high positional errors occur.Materials and methodsTen patients without the VOXELAN system (non-VXLN group) and 10 patients with the VOXELAN as the pre-positioning procedure (VXLN group) were included in this analysis. Twelve regions of interest (ROI) were defined in all the patients to verify any misalignment during radiotherapy. Thirteen ROIs were defined on the isocenter.ResultsCompared with the non-VXLN group, the translational positional errors of the VXLN group were the same for all the ROIs. The mean translational positional errors of the VXLN group in the longitudinal direction were approximately 0.1 mm, and the standard deviation was the largest among the three directions in all the ROIs. The magnitude of the standard deviation in the non-VXLN group varied independently of the ROI and direction. The standard deviations of the VXLN group in the longitudinal direction were large in all the ROIs, while the standard deviations in the vertical and lateral directions were small.ConclusionPre-positioning with a surface guidance system reduced the body twist and rotation, which could not be corrected by image-guided radiotherapy alone. Since the VOXELAN can detect positioning errors quickly and without additional radiation exposure to the patient, it can be used as a tool for pre-positioning in radiotherapy. 相似文献
Influenza viruses (FLUV) are continuously evolving, which explain the occurrence of seasonal influenza epidemics and the need to review the vaccine strain composition annually. The aim is to describe the genetic diversity and clinical outcomes of FLUV detected at a tertiary university hospital in Barcelona (Spain) during the 2012–2016 seasons.
Methods
The detection of FLUV from patients attended at the Emergency Department or admitted to the hospital was performed by either immunofluorescence or PCR-based assays. A specific real-time one-step multiplex RT-PCR was performed for influenza A (FLUAV) subtyping. The complete coding haemagglutinin domain 1 (HA1) and neuraminidase (NA) (2015–2016) protein sequences from a representative sampling were molecular characterised.
Results
A total 1774 (66.1%) FLUAV and 910 (33.9%) influenza B (FLUBV) cases were laboratory-confirmed. The hospitalisation rate was different between seasons, being the highest (81.4%) during the 2014–2015 season. FLUV were genetically close to vaccine strains except to the 2014–2015, in which most characterised A(H3N2) viruses belonged to a genetic group different from the vaccine strain. During the 2015–2016 season, B/Victoria-like viruses were the most predominant, but this component was not included in the trivalent vaccine used. Mutations D222G or D222N in HA1-domain were found in 3 A(H1N1)pdm09 strains from ICU-admitted cases. Three A(H1N1)pdm09 strains carried the NA H275Y (2) and S247N (1) mutations, respectively related to resistance or decreased susceptibility to oseltamivir.
Conclusions
The circulation of drifted A(H3N2) strains during the 2014–2015 season was related to the high hospitalisation rate due to the mismatch with the vaccine strains. The predominance of a FLUBV lineage not included in the trivalent influenza vaccine during the 2015–2016 season highlights the need to use a tetravalent influenza vaccine. Virological surveillance of viral variants carrying protein changes that alter tropism and susceptibility to antivirals features should be strengthened in hospital settings. 相似文献
BackgroundIn March 2011, the U.S. Food and Drug Administration licensed adenovirus type 4 and type 7 vaccine, live, oral (Barr Labs, Inc.) (adenovirus vaccine) for use in military personnel 17 through 50 years of age. The vaccine was first universally administered to U.S. military recruits in October 2011. We investigated adverse event (AE) reports following the adenovirus vaccine submitted to the Vaccine Adverse Event Reporting System (VAERS).MethodsWe searched the VAERS database for U.S. reports among persons who received adenovirus vaccine during October 2011 through July 2018 including participants in a military observational study. We reviewed all serious reports and accompanying medical records. We compared the proportion of serious reports in a proxy military recruit population and reviewed all reports of suspected allergic reactions following adenovirus vaccination.ResultsDuring the analytic period, VAERS received 100 reports following adenovirus vaccination; 39 (39%) were classified as serious and of these, 17 (44%) were from the observational study. One death was reported. Males accounted for 72% of reports. Median age of vaccinees was 19 years (range 17–32). The most frequently reported serious AEs were Guillain Barré syndrome (GBS) (n = 12) and anaphylaxis (n = 8); of these, two GBS and all the anaphylaxis reports were reported in the observational study. Reports documented concurrent receipt of multiple other vaccines (95%) and penicillin G (IM Pen G) or other antibiotics (50%).ConclusionsThe reporting rate for serious AEs was higher than with other vaccines administered in the comparison military recruit population (39% vs 18%); however, we identified no unexpected or concerning pattern of adenovirus vaccine AEs. Co-administration of vaccines and IM Pen G was commonly reported in this military population. These exposures may have contributed to the GBS and anaphylaxis outcomes observed with the adenovirus vaccine. Future adenovirus vaccine safety studies in a population without these co-administrations would be helpful in clarifying the vaccine’s safety profile. 相似文献
Activities of tedizolid and comparators were evaluated against gram-positive isolates responsible for skin and skin structure infections, pneumonia, and bloodstream infections. Non-duplicate gram-positive isolates (8011) were collected from 20 European countries/regions.
Tedizolid (0.12?mg/L) showed similar results of minimum inhibitory concentration required to inhibit the growth of 50% of organisms (MIC50) regardless of pathogen/group or infection type, except for coagulase-negative staphylococci, Enterococcus faecalis, and viridans group streptococci (VGS), against which tedizolid had MIC50 values of 0.06, 0.25, and 0.06?mg/L, respectively. Similar results of tedizolid MIC50 and minimum inhibitory concentration required to inhibit the growth of 90% of organisms (MIC90) (MIC50/90, 0.12/0.12?mg/L) were obtained against methicillin-resistant Staphylococcus aureus and methicillin-susceptible S. aureus. Tedizolid, linezolid, and daptomycin were active against enterococci. Tedizolid (MIC90, 0.12–0.25?mg/L), ceftaroline (MIC90, 0.12?mg/L), and vancomycin (MIC90, 0.25–0.5?mg/L) had the lowest MIC90 values against Streptococcus pneumoniae and VGS, whereas ceftaroline (MIC90, ≤0.015?mg/L), penicillin (MIC90, ≤0.06?mg/L), ceftriaxone (MIC90, ≤0.06–0.12?mg/L), and tedizolid (MIC90, 0.12?mg/L) were the most potent against β-haemolytic streptococci.
Tedizolid displayed potent activity against gram-positive isolates from Europe, regardless of infection type. 相似文献
IntroductionLung cancer is the leading cause of cancer-death worldwide. The U.S. Preventative Services Task Force (USPTSF) approved screening for current or former smokers aged 55–80 based on the results of the National Lung Screening trial (NLST). Following the NLST, new evidence has emerged from clinical trials and updates to previous trials prior to the anticipated update to the USPSTF guideline. We review the new evidence on lung cancer screening with low dose computed tomography (LDCT) and the surgical implications.MethodsA review of new literature was performed pertaining to lung cancer screening since implementation of UPSTF guidelines. Articles for inclusion were identified by both authors’, then search of the Pubmed and Cochrane database was performed from January 1st, 2013 through February 4th, 2020 using the MeSH search terms: “lung cancer”; “screening”; “low dose CT”. The results of these studies are summarized.ResultsWe identified multiple prospective randomized control trials and meta-analysis since the NLST supporting lung cancer-specific mortality with screening. We identified new nodule classification systems and the development of risk-models which may reduce false positive rates and identify high risk patients not currently eligible for screening. Finally, we discussed the surgical implications of screening.ConclusionNew data supports NLST findings and show ongoing benefit to LDCT for lung cancer screening. Standardized LDCT screening classification has been shown to reduce harm and lower false positive rates. Further study is needed regarding use of risk-modeling. Screening will require an increase in the thoracic workforce to accommodate the amount of surgically operable cancers. 相似文献