Out of the boxes,out of the silos: The need of interdisciplinary collaboration to reduce poor-quality medical products in the supply chain

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.     

Variation in use of open and laparoscopic distal pancreatectomy and associated outcome metrics in a universal health care system

BackgroundUniversal health care (UHC) should ensure equal access to and use of surgery, but few studies have explored variation in UHC systems. The objective was to describe practice of distal pancreatectomy in Norway covered exclusively by an UHC.MethodsData on all patients undergoing distal pancreatectomy from the Norwegian Patient Register over a 5-year period. Age- and gender-adjusted population-based resection rates (adj. per million/yr) for distal pancreatectomy were analysed across 4 regions and outcomes related to splenic salvage rate, hospital stay, reoperation, readmissions and 90-day mortality risk between regions. Risk is reported as odds ratio (OR) with 95% confidence interval (c.i.).ResultsRegional difference exist in terms of absolute numbers, with the majority of procedures done in one region (n = 331; 59.7%). Regional variation persisted for age- and gender-adjusted population-rates, with highest rate at 23.8/million/yr and lowest rate at 13.5/mill/yr (for a 176% relative difference; or an absolute difference of +10.3 resections/million/yr). Overall, a lapDP instead of an open DP was 3.5 times more likely in SouthEast compared to all other regions combined (lapDP rate: 83% vrs 24%, respectively; OR 15.4, 95% c.i. 10.1–23.5; P < 0.001). The splenic salvage rate was lower in SouthEast (19.9%) compared to all other regions (average 26.5%; highest in Central-region at 37.0%; P = 0.010 for trend). Controlled for other factors in multivariate regression, ‘region’ of surgery remained significantly associated with laparoscopic access.ConclusionDespite a universal health care system, considerable variation exists in resection rates, use of laparoscopy and splenic salvage rates across regions.     

Protective immunity against influenza virus challenge by norovirus P particle-M2e and HA2-AtCYN vaccines in chickens

Development of a broadly reactive influenza vaccine that can provide protection against emerging type A influenza viruses is a big challenge. We previously demonstrated that a vaccine displaying the extracellular domain of the matrix protein 2 (M2e) on the surface loops of norovirus P-particle (M2eP) can partially protect chickens against several subtypes of avian influenza viruses. In the current study, a chimeric vaccine containing a conserved peptide from the subunit 2 of hemagglutinin (HA) glycoprotein (HA2) and Arabidopsis thaliana cyanase protein (AtCYN) (HA2-AtCYN vaccine) was evaluated in 2-weeks-old chickens. Depending on the route of administration, the HA2-AtCYN vaccine was shown to induce various levels of HA2-specific IgA in tears as well as serum IgG, which were associated with partial protection of chickens against tracheal shedding of a low pathogenicity H5N2 challenge virus. Furthermore, intranasal administration with a combination of HA2-AtCYN and M2eP vaccines resulted in enhanced protection compared to each vaccine alone. Simultaneous intranasal administration of the vaccines did not interfere with secretory IgA induction by each vaccine. Additionally, significantly higher M2eP-specific proliferative responses were observed in peripheral blood mononuclear cells of all M2eP-vaccinated groups when compared with the mock-vaccinated group. Although tripling the number of M2e copies did not enhance the protective efficacy of the chimeric vaccine, it significantly reduced immunodominance of P-particle epitopes without affecting the robustness of M2e-specific immune responses. Taken together, our data suggests that mucosal immunization of chickens with combinations of mechanistically different cross-subtype-conserved vaccines has the potential to enhance the protective efficacy against influenza virus challenge.     

An Assessment of Emergency Nurses’ Perspectives on Nurse-Driven Human Immunodeficiency Virus Testing in the Emergency Department

IntroductionEngaging emergency clinicians in universal human immunodeficiency virus screening is paramount to achieving goals of reengaging human immunodeficiency virus–positive persons into care, identifying new human immunodeficiency virus cases, and linking them to care. The study aim was to identify beliefs and barriers towards opt-out human immunodeficiency virus testing among emergency nurses.MethodsA cross-sectional study used Qualtrics software to deliver a survey on a tablet device to emergency nurses in a private Level 1 trauma hospital in Houston, Texas during downtimes of their clinical shifts. The survey evaluated perspectives on human immunodeficiency virus screening and knowledge relative to rapid screening and human immunodeficiency virus prevalence rates locally and nationally.ResultsFifty emergency nurses were enrolled. Few nurses accurately identified human immunodeficiency virus prevalence rates at the local hospital and city level (10% and 42%, respectively). Most (54%) of nurses correctly estimated human immunodeficiency virus prevalence rates nationally. Nearly half of the nurses (42.0%) correctly predicted the cost of a rapid human immunodeficiency virus test with accuracy and most were willing to offer rapid human immunodeficiency virus testing all the time (60.0%). Eighty-eight percent of nurses were supportive of facilitating universal human immunodeficiency virus screening. However, 92.0% strongly supported human immunodeficiency virus testing for high risk patients only when compared to 80.0% support of testing for all eligible patients. Qualitative data revealed time constraints and follow-up concerns as barriers.DiscussionEmergency nurses reported barriers that sometimes prevented application of Centers for Disease Control and Prevention recommendations to human immunodeficiency virus screening. Strategies to overcome these barriers are instrumental to programmatic success. Solutions can corroborate the importance of emergency nurses to the nation’s Ending the HIV Epidemic plan.     

Readability of Patient Educational Materials in Hip and Knee Arthroplasty: Has a Decade Made a Difference?

BackgroundThe Internet has become an increasingly popular resource among orthopedic patients for health education. Numerous organisations recommend that patient educational materials (PEMs) should not exceed the 6^th grade reading level. Despite this, studies have repeatedly shown the reading grade level (RGL) of PEMs to be too advanced across a range of surgical specialties. We aimed to determine the readability of online hip and knee arthroplasty PEMs.MethodsThe readability of 134 articles pertaining to hip and knee arthroplasty from 5leading worldwide healthcare websites were assessed, using 8 readability formulae; the Flesch-Kincaid Reading Grade Level, the Flesch Reading Ease Score, Raygor Estimate, SMOG, Coleman-Liau, Fry, FORCAST and Gunning Fog. The mean RGL was compared to the 6^th and 8^thgrade reading level. The mean RGL of each website was also compared.ResultsThe mean cumulative RGL was 12 (range = 7-16.1). No articles (0%) were written at a 6^th grade reading level and only 4 articles (3%) were written at or below the 8^th grade reading level. The mean RGL was significantly higher than the 6^th (95% CI, 5.62-6.30; P < .0001) and 8^th grade reading level (95% CI, 3.63-4.30; P < .0001). There was a significant difference between the RGLs of the 5websites (P = .001).ConclusionArthroplasty PEMs produced by leading worldwide healthcare organisations have readability scores that are above the recommended levels. Given the imperative role of health literacy in patient outcomes and satisfaction, and the increasing prevalence of Internet use among orthopedic patients, a substantial amount of work needs to be done to improve the readability of these materials.     

Subtype Distribution,Clinical Features,and Survival in B-cell Chronic Lymphoproliferative Disorders in China: A Review of 1592 Cases

BackgroundB-cell chronic lymphoproliferative disorders (B-CLPDs) are characterized by the sustained accumulation of monoclonal B cells. Limited studies have systematically described the clinical features and outcomes of the whole patient group, especially in Eastern populations.Patients and MethodsA total of 1592 patients with newly diagnosed B-CLPD were enrolled. Chronic lymphocytic leukemia (CLL) accounted for 39%, and Waldenström macroglobulinemia (WM), leukemic marginal zone lymphoma, follicular lymphoma (FL), and mantle cell lymphoma (MCL) constituted 13%, 13%, 9%, and 8% of cases, respectively.ResultsThe median age at diagnosis was 58 years, and the male/female ratio was 1.8:1. The 17p and 11q deletions were most common in MCL (36% and 17%, respectively), and 13q deletion and trisomy 12 were most frequent in CLL (35% and 21%, respectively). Patients with leukemic MCL had significantly worse survival than that of patients with other disease entities, with a 3-year overall survival (OS) of 58%, followed by 68.2% for WM/lymphoplasmacytic lymphoma. Those with CLL, leukemic marginal zone lymphoma, and FL had relatively favorable outcomes, with a 5-year OS > 80%. The survival of patients with B-CLPDs has improved over time with the emergence of novel drugs (3-year OS improvement from 82.1% to 92.2%). The improvement in survival mainly resulted from improvement among patients with MCL, WM/lymphoplasmacytic lymphoma, and FL. On multivariate analysis, only hemoglobin, lactate dehydrogenase, and 17p deletion were independently associated with survival (hazard ratio, 1.6, 2.0, and 3.1, respectively).ConclusionsComprehensive analysis of the clinical characteristics, immunophenotypic profiles, and cytogenetic features can be helpful in the differential diagnosis, especially for patients without a non–bone marrow biopsy specimen available. Universal prognostic factors could help with the early detection of high-risk patients and stratification for risk-adapted therapy.     

Recombinant M2e outer membrane vesicle vaccines protect against lethal influenza A challenge in BALB/c mice

Currently approved influenza vaccines predominantly protect through antibodies directed against the highly variable glycoprotein hemagglutinin (HA), necessitating annual redesign and formulation based on epidemiological prediction of predominant circulating strains. More conserved influenza protein sequences, such as the ectodomain of the influenza M2 protein, or M2e, show promise as a component of a universal influenza A vaccine, but require a Th1-biased immune response for activity. Recently, recombinant, bacterially derived outer membrane vesicles (OMVs) demonstrated potential as a platform to promote a Th1-biased immune response to subunit antigens. Here, we engineer three M2e-OMV vaccines and show that all elicit strong IgG titers, with high IgG2a:IgG1 ratios, in BALB/c mice. Additionally, the administration of one M2e-OMV construct containing tandem heterologous M2e peptides (M2e4xHet-OMV) resulted in 100% survival against lethal doses of the mouse-adapted H1N1 influenza strain PR8. Passive transfer of antibodies from M2e4xHet-OMV vaccinated mice to unvaccinated mice also resulted in 100% survival to challenge, indicating that protection is driven largely via antibody-mediated immunity. The potential mechanism through which M2e-OMVs initiated the immune response was explored and it was found that the constructs triggered TLR1/2, TLR4, and TLR5. Our data indicate that OMVs have potential as a platform for influenza A vaccine development due to their unique adjuvant profile and intrinsic pathogen-mimetic nature.