Enhancement of peripheral seal of medical face masks using a 3-dimensional-printed custom frame.

BACKGROUND: During the COVID-19 pandemic, American Society for Testing and Materials level 3 and level 2 medical face masks (MFMs) have been used for most health care workers and even for the first responders owing to a shortage of N95 respirators. However, the MFMs lack effective peripheral seal, leading to concerns about their adequacy to block aerosol exposure for proper protection. The purpose of this study was to evaluate the peripheral seal of level 3 and level 2 MFMs with a 3-dimensional (3D-) printed custom frame. METHODS: Level 3 and level 2 MFMs were tested on 10 participants with and without a 3D-printed custom frame; the efficiency of mask peripheral seal was determined by means of quantitative fit testing using a PortaCount Fit Tester based on ambient aerosol condensation nuclei counter protocol. RESULTS: The 3D-printed custom frame significantly improved the peripheral seal of both level 3 and level 2 MFMs compared with the masks alone (P < .001). In addition, both level 3 and level 2 MFMs with the 3D-printed custom frame met the quantitative fit testing standard specified for N95 respirators. PRACTICAL IMPLICATIONS: The 3D-printed custom frame over level 3 and level 2 MFMs can offer enhanced peripheral reduction of aerosols when using collapsible masks. With the shortage of N95 respirators, using the 3D-printed custom frame over a level 3 or level 2 MFM is considered a practical alternative to dental professionals.

Expression, localization and clinical application of exogenous Smith proteins D1 in gene transfected HEp-2 cells.

AIM: To establish an improved substrate for an indirect immunofluorescence test (IIF) to detect anti-Sm antibody. METHODS: Full-length Smith protein D1(Sm-D1) complementary DNA was obtained from human larynx carcinoma cell line HEp-2 by reverse transcription - polymerase chain reaction (RT-PCR) and cloned into the mammalian expression vector pEGFP-C1. The recombinant plasmid pEGFP-Sm-D1 was transfected into HEp-2 cells. The expression, localization and antigenicity of fusion proteins of green fluorescent protein (GFP) in transfected cells were confirmed by means of immunoblotting (IBT), confocal fluorescence microscopy and IIF analysis. Transfected HEp-2 cells were analyzed with reference serum and compared with untransfected HEp-2 cells by IIF. RESULTS: Stable expression of the Sm-D1-GFP was maintained for more than ten generations. This Sm-D1-GFP showed the antigenicity of Sm-D1 with a characteristic phenotype in IIF.Six of 12 serum specimens from systemic lupus erythematosus contained both 29/28 and 13.5 kDa proteins and showed characteristic immunofluorescent patterns. The same phenomenon appeared in 3/6 serum samples which contained 29/28 kDa proteins only. Sera from 10 healthy donors did not react with HEp-Sm-D1 or HEp-2 at 1:80 attenuant degrees. No alteration in expression, localization and morphology was observed when HEp-Sm-D1 or HEp-2 interacted with the reference sera which could react with Ro/SSA, La/SSB, ß2GP1, centromere, histone, and Scl-70 antibodies in routine IIF tests. CONCLUSION: As a new kind of substrate of IIF, HEp-Sm-D1 can be used to detect anti-Sm antibodies. Transfected HEp-2 cells keep the immunofluorescent property of HEp-2 cells in immunofluorescence anti-nuclear antibody (IFANA) test and could potentially be used as substrate for routine IFANA detection.

Cost effectiveness of different treatment strategies in the treatment of patients with moderate to severe rheumatoid arthritis in china.

BACKGROUND: To analyse the cost-effectiveness of traditional disease-modifying anti-rheumatic drugs (tDMARDs) compared to biological therapies from the perspective of Chinese society. METHODOLOGY/PRINCIPAL FINDINGS: A mathematical model was developed by incorporating the clinical trial data and Chinese unit costs and treatment sequences from a lifetime perspective. Hypothetical cohorts with moderate to severe RA were simulated. The primary outcome measure-quality-adjusted life years (QALYs)-was derived from disease severity (HAQ scores). Primary analysis included drug costs, monitoring costs, and other costs. Probabilistic and one-way sensitivity analyses were performed. Treatment sequences that included TNF antagonists and rituximab produced a greater number of QALYs than tDMARDs alone or TNF antagonists plus DMARDs. In comparison with tDMARDs, the incremental cost-effectiveness ratios (ICERs) for etanercept, infliximab, and adalimumab without rituximab were $77,357.7, $26,562.4 and $57,838.4 per QALY and $66,422.9, $28,780.6 and $50,937.6 per QALY, for etanercept, infliximab, and adalimumab with rituximab. No biotherapy was cost-effective under the willingness to pay threshold when the threshold was 3 times the per capita GDP of China. When 3 times the per capita GDP of Shanghai used as the threshold, infliximab and rituximab could yield nearly 90% cost-effective simulations in probabilistic sensitivity analysis. CONCLUSIONS/SIGNIFICANCE: tDMARD was the most cost-effective option in the Chinese healthcare setting. In some relatively developed regions in China, infliximab and rituximab may be a favorable cost-effective alternative for moderate to severe RA.

Sterilization analysis of contaminated healing abutments and impression copings.

This study investigated sterilization of used implant impression copings and healing abutments. Components were analyzed after contamination with Enterococcus foecalis, followed by multiple rounds of sterilization by both steam autoclave and Chemiclave protocols. The authors' results demonstrated that used components showed sterility equal to new components without any visible distortion. These data suggest that component resterilization and reuse may be justified or at least considered in clinical practice. Also, implications for cost savings in the placement of implants are advanced.

New insights into the role and mechanism of macrophage migration inhibitory factor in steroid-resistant patients with systemic lupus erythematosus.

INTRODUCTION: Glucocorticoid (GC) therapy remains important in improving the prognosis of patients with systemic lupus erythematosus (SLE). However, some patients do not achieve an effective response with GC treatment, creating an obstacle to the remission of SLE. Identification of the underlying mechanisms responsible for steroid resistance can be significant. Macrophage migration inhibitory factor (MIF) arouses our interest because of its reciprocal relationship with GCs. In the present study, we investigated for the first time whether MIF correlated with steroid resistance in SLE and explored potential mechanisms of action. METHODS: Sixty-two patients with SLE (40 steroid sensitive and 22 steroid resistant) and 21 normal controls were recruited. Serum levels of MIF were measured by ELISA. Cytosolic MIF and IκB expression in peripheral blood mononuclear cells (PBMCs) were determined by western blotting. The electrophoretic mobility shift assay was assessed by NF-κB in nuclear aliquots. Gene silencing was applied to reduce expression of MIF in PBMCs in steroid-resistant patients. PBMCs obtained from steroid-sensitive patients were treated with recombinant human MIF of different concentrations. RESULTS: MIF levels in serum and PBMCs were higher in steroid-resistant patients compared with steroid-sensitive patients and controls. In contrast to the steroid-sensitive group, NF-κB levels were significantly higher and IκB levels lower in steroid-resistant patients. After MIF gene silencing, IκB levels in cells from steroid-resistant patients were increased. In steroid-sensitive patients, a decrease in IκB levels and an increase in NF-κB expression from baseline were detected in PBMCs treated with a higher concentration of recombinant human MIF. Treatment with recombinant human MIF did not regulate expression of IκB and NF-κB in PBMCs from patients treated with an anti-MIF monoclonal antibody. CONCLUSIONS: Our results indicated that MIF may play a role in the formation of steroid resistance in SLE by affecting the NF-κB/IκB signaling cascade. As a regulator of glucocorticoid sensitivity, MIF may be a potential target for steroid sparing.

Implementing health information technology to improve the process of health care delivery: a case study.

Integration of health information is critical to the provision of effective, quality care in today's fragmented health care system. The increasing prevalence of chronic conditions and the demand for a comprehensive understanding of patient health on the part of providers are driving the need for the integration of health information through electronic health information systems. Two distinct health information systems currently utilized in the health care field include electronic medical records (EMR) and chronic disease management systems (CDMS). The integration of these systems is likely to enable the efficient management of health information and improve the quality of health care as it would provide real-time patient information in a coordinated manner. The lack of real-time information may result in delayed treatment, uninformed decisions, inefficient resource use, and medical errors. Despite their importance and widespread support, these systems have slow provider adoption rates. Our understanding of how health information technology may be used to improve health care is limited by the relative paucity of research on the adoption, integration, and implementation of these 2 types of systems. This paper documents the use of an EMR at Marshfield Clinic, a multidisciplinary group practice in the United States. We review the concomitant use of an EMR for clinical data capture and the implementation of a proprietary CDMS, InformaCare, for care management of chronic diseases. These 2 systems allow providers to deliver health care using evidence-based guidelines that meet the Institute of Medicine's aim of providing safe, efficient, patient-centered, and timely care.

Comparative tooth whitening efficacy of 18% carbamide peroxide liquid whitening gel using three different regimens.

OBJECTIVE: Recently, a novel paint-on liquid whitening gel--Colgate Simply White Clear Whitening Gel--which contains 18% carbamide peroxide, has been developed as a self-administered tooth bleaching system. The purpose of the present study was to determine the efficacy and safety of this product using alternate exaggerated or simplified treatment regimens. METHODOLOGY: This was a three-week clinical trial using a parallel, double-blind, stratified protocol with three different instructions for application: 1) twice-daily, no air-drying, and 15 minutes without eating/drinking; 2) three times daily, 30-second air-drying and 30 minutes without eating/drinking; or 3) four times daily, 30-second air-drying and 30 minutes without eating/drinking. One-hundred and twenty (120) healthy volunteers were balanced into three equal groups based on shade scores (A3 or darker). Clinical evaluations (shade guide, oral tissue health, gingival index and visual analog sensitivity score) were performed on each group at baseline and weekly for the next 21 days. At the conclusion of the study, a survey of the subjects' opinions on their assigned product regimen was also conducted. RESULTS: Subjects who used Colgate Simply White Clear Whitening Gel three and four times daily achieved the greatest shade improvement (5.88 +/- 1.53 shades, and 5.57 +/- 1.54, respectively). However, these values were only about one shade better than the value observed for the more convenient, twice-daily, "no-dry" regimen (4.51 +/- 1.77 shades), though they were statistically significant (p < 0.05). The result for the four-times daily protocol was not statistically different from the three-times group. Also, no differences were observed between the groups concerning oral tissue health, gingival index or tooth sensitivity, and no adverse effects were observed or reported regardless of the regimen used. Surveys completed by the subjects showed that those who used the twice-daily, "no-dry" regimen found the product to be the easiest to use, the most comfortable and the most pleasant tasting. CONCLUSION: It can be concluded from the clinical data that three or four applications of Colgate Simply White Clear Whitening Gel per day provided better efficacy. In addition, the use of the whitening gel twice daily, even without "dry time" and only 15 minutes without eating/drinking, yielded results that were comparable to previously reported results using the original on-label directions. The potential additional benefit to the "simplified regimen" is that it was perceived to be the most convenient and comfortable. The use of Colgate Simply White Clear Whitening Gel up to four times daily for up to three weeks is also safe, and the tendency of abusing the product with more frequent daily use may be deterred by the inconvenience reported by the study subjects.

Prevalence and outcomes of anemia in geriatrics: a systematic review of the literature.

Anemia is a common concern in geriatric health, but its exact incidence and prevalence are unclear. Several studies have addressed this issue with discrepant results. Estimates of anemia prevalence reported in the articles reviewed here range from 2.9% to 61% in elderly men and from 3.3% to 41% in elderly women. This variability is related to a number of factors, including the setting of the study, the health status of the subject population, and the criteria used to define anemia. The criteria set by the World Health Organization (WHO)--hemoglobin level <120.0 g/L for women and <130.0 g/L for men--are most frequently, but not universally, used. Even so, their appropriateness in older populations may be questioned. Most existing reports indicate that elderly men have higher rates of anemia than do elderly women, but the threshold values are, in general, higher for men than for women. Incidence of anemia rises with age; some studies report a particularly notable increase in prevalence of anemia in the oldest subjects, those > or =85 years of age. Whereas anemia is associated with symptoms ranging from weakness and fatigue to increased falls and depression, and in severe cases can lead to congestive heart failure, few studies have systematically examined functional, clinical, and economic outcomes or patient satisfaction in the elderly with anemia. Future directions for research on anemia should include a more detailed examination of the importance of aging or age-related diseases on the pathogenesis of anemia, an assessment of the importance of anemia on outcomes such as physical function and cognitive function, and an analysis of whether impairments associated with anemia are amenable to correction by improving hemoglobin concentration.

Prevalence and outcomes of anemia in inflammatory bowel disease: a systematic review of the literature.

The prevalence of anemia in patients with inflammatory bowel disease ranges from 8.8% to 73.7% depending on the patient subpopulation. Anemia, one of many extraintestinal complications of ulcerative colitis and Crohn disease, is generally defined as a hemoglobin value <120 g/L or hematocrit <0.4; severe anemia is defined as a hemoglobin level <100 g/L. Many patients have been shown to be intolerant of oral iron replacement therapy or their anemia was refractory to such supplementation. Correction of anemia through the administration of intravenous iron saccharate and/or supplemental erythropoietin has been shown to improve patient hematologic indices and quality of life. Future studies are needed to determine the type of patients at highest risk of developing severe anemia as well as the treatment interventions with the most beneficial effect.

Prevalence and outcomes of anemia in rheumatoid arthritis: a systematic review of the literature.

Anemia is a common comorbidity in individuals with rheumatoid arthritis (RA). In fact, anemia of the type characterized by low serum iron concentrations in conjunction with adequate iron stores is frequently associated with RA and has served as a model for anemia of chronic disease. A systematic search of the scientific literature published since January 1966 identified 19 articles that reported findings on either the prevalence of anemia in patients with RA or outcomes for patients with anemia and RA. Ten articles addressed the prevalence of anemia in patients with RA. Estimates of the prevalence of mild anemia ranged between 33% and 60%; however, the 2 studies that examined demographics in patients with RA did not identify subpopulations at particular risk for anemia. Twelve articles assessed the impact of the resolution of anemia on symptoms and quality of life (QOL) in patients with RA. For many of the parameters assessed-including swollen, painful, and tender joints, pain, muscle strength, and energy levels-a positive correlation was observed between improvement of symptoms and the resolution of anemia. In addition, 2 studies reported a significant improvement in QOL scores in patients with RA who experienced a response to treatment for anemia. These results suggest that (1) patients with RA who have anemia are likely to have more severe joint disease and (2) if the anemia is successfully treated, the joint disease will likely respond to treatment as well. Whether improvements in QOL and/or joint symptoms occur with improvement of anemia, independent of other signs of an overall response to RA therapy, remains to be determined.

Quality of life in managed care patients with irritable bowel syndrome.

The relationship between the severity of abdominal discomfort/pain and generic and disease-specific quality of life (QoL) was explored in patients with irritable bowel syndrome in an MCO. Subjects were stratified into four symptom-severity groups. Descriptive and multivariate analyses were used to examine the relationship of QoL to severity of abdominal discomfort/pain. Generic and disease-specific QoL scores declined as severity of abdominal discomfort/pain increased. The lowest 36-Item Short-Form Health Survey scores for respondents with the most severe abdominal discomfort/pain were for role physical (24.2 +/- 35.4) and vitality (33.7 +/- 19.2). In multivariate regression models controlling for age, sex, work status and education, severity of abdominal discomfort/pain was a significant independent predictor of QoL.

Determining the appropriateness of selected surgical and medical management options in recurrent stroke prevention: a guideline for primary care physicians from the National Stroke Association work group on recurrent stroke prevention.

Despite a decade of successful clinical trials for stroke prevention, substantial gaps exist in the application and implementation of this information in community practice. The frequency of guideline use is low, and there remains controversy regarding the standard of practice. Patients with stroke may have multiple risk factors and concomitant stroke mechanisms, factors that are not addressed in stroke clinical trials and guideline statements. New guidelines are needed to account for these complexities and to provide primary care physicians a practical means to achieve stroke prevention. We sought to develop guidelines that can be implemented by primary care physicians to enhance the use of medical and surgical measures for recurrent stroke prevention. We sought to test the applicability of current evidence-based guidelines to daily practice with routine and complex patient case scenarios to determine whether these could be simplified into a more easily applied form for primary care physicians. We used RAND/UCLA Appropriateness Methodology to develop guidelines for the use of interventions supported by randomized controlled trials including carotid revascularization, anticoagulant therapy, antiplatelet therapy, and blood pressure management for the prevention of recurrent stroke. After a systematic literature review of randomized clinical trials we developed a comprehensive list of indications or clinical scenarios to capture decision making. A diverse multidisciplinary panel reviewed and rated each indication according to the RAND Appropriateness Method. First, panelists rated each scenario (1-3 for inappropriate, 4-6 for uncertain, and 7-9 for appropriate) without interaction with other panelists. "Appropriate" was defined as the expected health benefit exceeding its expected negative consequences by a sufficient margin. At a formal interactive session, panelists re-rated all indications. Overall carotid endarterectomy was rated as appropriate when there was 50% to 99% ipsilateral symptomatic carotid artery stenosis, inappropriate with <50% or 100% stenosis (total occlusion), and uncertain when the surgical risk was high. Carotid angioplasty was generally rated as of uncertain value. When there was atrial fibrillation, anticoagulation with warfarin was rated as appropriate when there was a low bleeding risk but of uncertain value when the bleeding risk was high. For patients who were not candidates for warfarin therapy, aspirin, aspirin plus extended-release dipyridamole, or clopidogrel were all rated as appropriate initial therapies. Ticlopidine was considered inappropriate and aspirin plus clopidogrel of uncertain value. With the exception of ticlopidine and aspirin, persons with a prior cerebral ischemic event while on aspirin could receive any of the aforementioned antiplatelet agents or combinations and be considered appropriately treated. The panelists rated a blood pressure of <130/80 mm Hg at 1 year after ischemic stroke as the target level and rated any of the following agents as appropriate initial therapies if there was no diabetes mellitus or proteinuria: diuretics, beta-blockers, angiotensin-converting enzyme inhibitors, angiotensin-converting enzyme receptor blockers, or combinations of a diuretic and an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker. Patient risk played a significant role in deterring the panel from recommending certain therapies; however, the presence of atrial fibrillation or large or small cerebral vessel syndromes rarely had significant influence on treatment decisions. Appropriateness was less where bleeding or surgical risk was excessive. Using consensus evidence from clinical trials, we have developed recurrent stroke prevention guidelines for routine and more complex patient scenarios according to appropriateness methodology. Broad application of these guidelines in primary practice promises to reduce the burden of recurrent stroke.

Comparison of clinical efficacy and safety of three professional at-home tooth whitening systems.

A three-cell, randomized, parallel, investigator-blinded clinical trial was conducted to compare the efficacy and safety of three professional at-home tooth whitening systems, including Crest Professional Whitestrips (6.5% H2O2), Day White 2 (7.5% H2O2) and Nite White Excel 2 (16% carbamide peroxide equivalent). Ninety subjects were randomly assigned to three groups (30/group). Subjects were instructed to use the assigned whitener following the manufacturers' instructions. Clinical examinations at baseline, and on days 3, 7, 14, and 18 (Day White), or 21 (Crest Professional Whitestrips and Nite White) included the following parameters: 1) oral tissues; 2) tooth shade by the Vitapan Classical shade guide; 3) tooth shade by a chromameter with a jig; and, 4) tooth sensitivity and gingival irritation. The results showed significant shade reductions with time in all three groups. Nite White resulted in significantly greater shade reductions in periods between days 7, 14, or 21 and baseline than did the other two systems. Tooth sensitivity and gingival irritation, which were mostly mild and transient, occurred in all groups. It is concluded that all three whitening systems evaluated are effective and safe. Nite White Excel is superior to the other two systems because it provides a greater whitening efficacy with comparable or lower incidence of tooth sensitivity and gingival irritation.

Physician attitudes toward strategies to promote the adoption of medical evidence into clinical practice.

BACKGROUND: [corrected] Promoting the adoption of medical evidence into clinical practice has been advocated as one approach to improving healthcare quality and reducing medical errors. Data describing the effectiveness of different strategies to achieve this goal in real-world settings are limited. OBJECTIVE: To determine the effectiveness of selected interventions on the adoption of medical evidence into clinical practice. STUDY DESIGN: A cross-sectional survey of a random sample of physicians selected from the American Medical Association's Physician Master File. PATIENTS AND METHODS: We examined the perceived effectiveness of 7 strategies (represented by 27 individual interventions) and 5 general approaches for promoting the adoption of medical evidence into clinical practice in 1100 practicing physicians. Respondent exposure to interventions was also determined. Regression analyses were performed to identify factors that affected effectiveness ratings. Analysis of variance was used to test the hypothesis of equal mean scores across different comparison groups. RESULTS: Of 1,100 surveys mailed, 63 (5.7%) were excluded and 431 were completed (response rate = 41.6%). Mean +/- SD effectiveness scores for the 27 individual interventions on a 5-point Likert scale ranged from 2.0 +/- 0.9 (literature received from insurance companies and managed care organizations) to 4.2 +/- 0.8 (one-on-one communication with respected colleagues). Ranges for the 7 strategies were 2.6 +/- 1.0 (patient-mediated interventions) to 3.6 +/- 0.9 (educational meetings) and for the 5 general approaches were 1.98 +/- 0.9 (administrative interventions) to 3.3 +/- 0.8 (provider education). The hypothesis of equal mean effectiveness scores was rejected for all comparisons (P < .001). Frequency of exposure was the only variable to predict effectiveness (P < .001 for all regression models). CONCLUSION: From the perspective of practicing physicians, the frequency of exposure to strategies for promoting the adoption of medical evidence into clinical practice strongly affects their perceived effectiveness.

Irritable bowel syndrome, health care use, and costs: a U.S. managed care perspective.

OBJECTIVE: We performed an evaluation of patient symptoms, health care use, and costs to define the burden of illness of irritable bowel syndrome (IBS) and the relation to the severity of abdominal pain/discomfort in a large health maintenance organization. METHODS: All 6500 adult health maintenance organization members who had undergone flexible sigmoidoscopy in the year 2000 were mailed a questionnaire that elicited Rome I symptom criteria and severity ratings for abdominal pain/discomfort. Multiple health care use measures were obtained from various administrative databases. IBS patients were compared with a control group of non-IBS subjects, and analyses were adjusted for age and sex. RESULTS: We received 2613 (40.2%) responses. Compared with non-IBS subjects over 2 yr, IBS patients had more outpatient visits (medical, surgery, and emergency, p < 0.05), were hospitalized more often (p < 0.05), and had more total outpatient prescriptions (p < 0.05) and IBS-related prescriptions (p < 0.05). Over 1 yr, total costs were 51% higher in IBS patients, who also had higher costs for outpatient visits, drugs, and radiology and laboratory tests (p < 0.05). Total costs were increased by 35%, 52%, and 59% in IBS patients with mild, moderate, and severe symptoms of abdominal pain/discomfort compared with non-IBS subjects (p < 0.05). CONCLUSIONS: Using Rome I symptom criteria, we found that IBS is associated with a broad pattern of increased health care use and costs. The severity of abdominal pain/discomfort is a significant predictor of health care use and costs for patients with IBS compared with non-IBS subjects.