Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more.

Background: Congenital toxoplasmosis is a treatable, preventable disease, but untreated causes death, prematurity, loss of sight, cognition and motor function, and substantial costs worldwide. Methods/Findings: In our ongoing USA feasibility/efficacy clinical trial, data collated with other ongoing and earlier published results proved high performance of an Immunochromatographic-test(ICT) that enables accurate, rapid diagnosis/treatment, establishing new paradigms for care. Overall results from patient blood and/or serum samples tested with ICT compared with gold-standard-predicate-test results found ICT performance for 4606 sera/1876 blood, 99.3%/97.5% sensitive and 98.9%/99.7% specific. However, in the clinical trial the FDA-cleared-predicate test initially caused practical, costly problems due to false-positive-IgM results. For 58 persons, 3/43 seronegative and 2/15 chronically infected persons had false positive IgM predicate tests. This caused substantial anxiety, concerns, and required costly, delayed confirmation in reference centers. Absence of false positive ICT results contributes to solutions: Lyon and Paris France and USA Reference laboratories frequently receive sera with erroneously positive local laboratory IgM results impeding patient care. Therefore, thirty-two such sera referred to Lyon's Reference laboratory were ICT-tested. We collated these with other earlier/ongoing results: 132 of 137 USA or French persons had false positive local laboratory IgM results identified correctly as negative by ICT. Five false positive ICT results in Tunisia and Marseille, France, emphasize need to confirm positive ICT results with Sabin-Feldman-Dye-test or western blot. Separate studies demonstrated high performance in detecting acute infections, meeting FDA, CLIA, WHO ASSURED, CEMark criteria and patient and physician satisfaction with monthly-gestational-ICT-screening. Conclusions/Significance: This novel paradigm using ICT identifies likely false positives or raises suspicion that a result is truly positive, rapidly needing prompt follow up and treatment. Thus, ICT enables well-accepted gestational screening programs that facilitate rapid treatment saving lives, sight, cognition and motor function. This reduces anxiety, delays, work, and cost at point-of-care and clinical laboratories. Author's Summary: Toxoplasmosis is a major health burden for developed and developing countries, causing damage to eyes and brain, loss of life and substantial societal costs. Prompt diagnosis in gestational screening programs enables treatment, thereby relieving suffering, and leading to > 14-fold cost savings for care. Herein, we demonstrate that using an ICT that meets WHO ASSURED-criteria identifying persons with/without antibody to Toxoplasma gondii in sera and whole blood with high sensitivity and specificity, is feasible to use in USA clinical practice. We find this new approach can help to obviate the problem of detection of false positive anti- T.gondii IgM results for those without IgG antibodies to T.gondii when this occurs in present, standard of care, predicate USA FDA cleared available assays. Thus, this accurate test facilitates gestational screening programs and a global initiative to diagnose and thereby prevent and treat T.gondii infection. This minimizes likelihood of false positives (IgG and/or IgM) while maintaining maximum sensitivity. When isolated IgM antibodies are detected, it is necessary to confirm and when indicated continue follow up testing in ∼2 weeks to establish seroconversion. Presence of a positive ICT makes it likely that IgM is truly positive and a negative ICT makes it likely that IgM will be a false positive without infection. These results create a new, enthusiastically-accepted, precise paradigm for rapid diagnosis and validation of results with a second-line test. This helps eliminate alarm and anxiety about false-positive results, while expediting needed treatment for true positive results and providing back up distinguishing false positive tests.

Laryngopharyngeal reflux: is laparoscopic fundoplication an effective treatment?

INTRODUCTION: Laryngopharyngeal reflux (LPR) is difficult to diagnose and treat owing to uncertainty relating to the underlying pathology. The initial management of LPR includes lifestyle modifications and oral medications. In patients who have failed to respond to proton pump inhibitor (PPI) therapy, anti-reflux surgery is considered; laparoscopic fundoplication is the surgery of choice. The primary aim of this review is to identify whether fundoplication is effective in improving signs and symptoms of LPR. The secondary aim is to identify whether patients who have had a poor response to PPIs are likely to have symptom improvement with surgery. The objective of the study is to establish the effect of laparoscopic fundoplication on the reflux symptom index score (RSI). METHODS: PubMed, Embase, Medline and Cochrane databases were used to search according to the PRISMA guidelines. Original articles assessing the efficacy of fundoplication in relieving symptoms of LPR were included. For each study, the efficacy endpoints and safety outcomes were recorded. FINDINGS: Nine studies from 844 initial records met the inclusion criteria: one prospective case control study, one retrospective case-control study, four prospective case series and three retrospective case series involving 287 fundoplications. All nine studies found fundoplication to be effective in improving symptoms of LPR (p < 0.05). CONCLUSION: Current evidence suggests laparoscopic fundoplication is an effective treatment for LPR and should be considered if medical management is unsuccessful.

Twenty-seven years of primary salivary gland carcinoma in Wales: an analysis of histological subtype and associated risk factors.

OBJECTIVE: Risk factors for salivary gland carcinoma are poorly understood. Although links between background radiation, smoking and obesity have been previously suggested, no studies have so far established any significant results. This study aimed to establish correlations between common environmental and lifestyle risk factors and different subtypes of salivary gland carcinoma. METHOD: A study of population data in Wales spanning 27 years was conducted; 2 national databases were used to identify 356 cases of primary salivary gland carcinoma over this period. Histological subtype of cancer and geographical location of each case was recorded. Public health data was used to establish radon levels, smoking, obesity and activity levels of populations in each geographical location. A population matched multivariate analysis of variance analysis was performed using histological subtype and risk factor data for each geographical location. RESULTS: A significantly higher incidence of mucoepidermoid cancer in populations with higher background radon levels (p = 0.006), epithelial-myoepithelial cancer in populations with higher smoking levels (p = 0.029) and adenoid cystic cancer in populations with higher obesity levels (p = 0.028) was found. CONCLUSION: To the authors' knowledge, this is the first study to establish significant links between background radiation, smoking and obesity with different subtypes of salivary gland carcinoma.

Laryngopharyngeal reflux: is laparoscopic fundoplication an effective treatment?

INTRODUCTION: Laryngopharyngeal reflux (LPR) is difficult to diagnose and treat owing to uncertainty relating to the underlying pathology. The initial management of LPR includes lifestyle modifications and oral medications. In patients who have failed to respond to proton pump inhibitor (PPI) therapy, anti-reflux surgery is considered; laparoscopic fundoplication is the surgery of choice. The primary aim of this review is to identify whether fundoplication is effective in improving signs and symptoms of LPR. The secondary aim is to identify whether patients who have had a poor response to PPIs are likely to have symptom improvement with surgery. The objective of the study is to establish the effect of laparoscopic fundoplication on the reflux symptom index score (RSI). METHODS: PubMed, Embase, Medline and Cochrane databases were used to search according to the PRISMA guidelines. Original articles assessing the efficacy of fundoplication in relieving symptoms of LPR were included. For each study, the efficacy endpoints and safety outcomes were recorded. FINDINGS: Nine studies from 844 initial records met the inclusion criteria: one prospective case control study, one retrospective case-control study, four prospective case series and three retrospective case series involving 287 fundoplications. All nine studies found fundoplication to be effective in improving symptoms of LPR (p < 0.05). CONCLUSION: Current evidence suggests laparoscopic fundoplication is an effective treatment for LPR and should be considered if medical management is unsuccessful.

Disability from chronic ear disease in Nepal assessed using the World Health Organization Disability Assessment Schedule 2.0 instrument.

OBJECTIVE: Globally, South Asia has the highest proportion of disabling hearing loss. There is a paucity of data exploring the associated hearing loss and disability caused by chronic middle-ear disease in South Asia in the setting of surgical outreach. This study aimed to measure disability using the World Health Organization Disability Assessment Schedule 2.0 in patients undergoing ear surgery for chronic middle-ear disease in an ear hospital in Nepal. METHOD: The World Health Organization Disability Assessment Schedule 2.0 was translated into Nepali and administered by interview to patients before ear surgery, and results were correlated with pre-operative audiograms. RESULTS: Out of a total of 106 patients with a mean age of 23 years, the mean World Health Organization Disability Assessment Schedule 2.0 score was 17.7, and the highest domain scores were for domain 6 'participation in society' at a score of 34. There was a positive correlation of World Health Organization Disability Assessment Schedule 2 score with hearing level (r = 0.46). CONCLUSION: Patients with ear disease in Nepal have had their disability measured using the World Health Organization Disability Assessment Schedule 2.0. Our study demonstrated a correlation between impaired hearing and disability in a surgical outreach context, which was an expected but not previously reported finding.

Patient engagement study to identify and improve surgical experience.

BACKGROUND: Patient engagement is the establishment of active partnerships between patients, families, and health professionals to improve healthcare delivery. The objective of this project was to conduct a series of patient engagement workshops to identify areas to improve the surgical experience and develop strategies to address areas identified as high priority. METHODS: Faculty surgeons and patients were invited to participate in three in-person meetings. Evaluation included identifying and developing strategies for three priority areas to improve the surgical experience and level of engagement achieved at each meeting. RESULTS: Sixteen faculty surgeons and 32 patients participated. Some 63 themes to improve the surgical experience were identified; the three highest-priority themes were physician communication, discharge process, and expectations at home after discharge. Individual improvement strategies for these three prioritized themes (12, 36 and 6 respectively) were used to develop a formal strategic plan, and included a physician communication survey, discharge process worksheet and video, and guideline regarding what to expect at home after discharge. Overall, the level of engagement achieved was considered high by over 85 per cent of the participants. CONCLUSION: A high level of patient engagement was achieved. Priorities were identified with patients and surgeons to improve surgical experience, and strategies were developed to address these areas.

Quality assessment of cancer patient education materials: the current state of systemic therapy patient education in fourteen cancer centres across Ontario, Canada.

PURPOSE: Most patients diagnosed with cancer are administered systemic therapy and these patients are counselled and given printed education (PE) materials. High rates of low health literacy highlight the need to evaluate the quality of these PE materials. METHODS: A current state assessment of the quality of PE materials was conducted in Ontario, Canada. Patient education leaders from 14 cancer centres submitted print materials on the topic of systemic cancer therapy to the assessment team. To report adherence to PE quality and health literacy best practices, the following validated measures were used: readability (FRY, SMOG and Flesch Reading Ease), understandability and actionability (Patient Education Materials Assessment Tool (PEMAT)). Materials at grade level 6 or lower and with PEMAT scores greater than 80% were considered to meet health literacy best practices. RESULTS: A total of 1146 materials were submitted; 366 met inclusion criteria and 83 were selected for assessment. Most materials scored below the 80% target for understandability (x̄ = 73%, 31-100%) and actionability (x̄ = 68%, 20-100%), and above the recommended grade 6 readability level (x̄ = grade 9) meaning that the majority did not meet quality standards or best practices. CONCLUSION: Results suggest that there is significant opportunity to improve the quality of PE materials distributed by cancer centres. The quality of PE materials is a critical safety and equity consideration when these materials convey important safety and self-care directives.

Advances in the Field of Bone Conduction Hearing Implants.

The number of marketed bone-conduction hearing implants (BCHIs) has been steadily growing, with multiple percutaneous devices and transcutaneous devices now available. However, studies assessing efficacy often have small sample sizes and employ different assessment methodologies. Thus, there is a paucity of evidence to guide clinicians to the most appropriate device for each patient. This paper outlines audiological guidelines for the latest devices, as well as research from the most up-to-date clinical trials. We also outline the evidence base for some potentially contentious issues in the field of bone conduction, including bilateral fitting of BCHIs in those with bilateral conductive hearing loss as well as the use of BCHIs in single-sided deafness (SSD). Bilateral fitting of BCHIs have been found to significantly increase the hearing thresholds in quiet and improve sound localization, but to give limited benefits in background noise. Studies conducted via multiple assessment questionnaires have found strong evidence of subjective benefits for the use of BCHIs in SSD. However, there is little objective evidence of benefit for SSD patients from sound localization and speech in noise tests.

Topical propranolol for infantile haemangiomas: a systematic review.

Infantile haemangiomas are the most common tumour of infancy. Whilst the majority are left untreated to involute spontaneously, residual skin changes commonly occur, particularly in superficial haemangiomas. The current first-line treatment for problematic lesions is oral propranolol; however due to the risk of systemic adverse effects, the use of off-label topical preparations has recently been investigated. Our systematic review was conducted in accordance with PRISMA guidelines. Four databases were searched to identify original articles evaluating the use of topical propranolol as the primary therapy for infantile haemangiomas. Twelve articles with a total of 597 patients and 632 haemangiomas were included. Three topical propranolol preparations were used, creams, ointments and gels and were all prepared by local pharmaceutical laboratories. The concentration of propranolol ranged from 0.5% to 5%. Treatment duration ranged from two weeks to 16.5 months. Overall, 90% of lesions improved following the initiation of topical propranolol. A good or excellent response, defined as a reduction in the size of at least 50%, was seen in 59% of lesions. Earlier initiation of treatment (less than 3 months of age) was associated with improved outcomes. No systemic adverse effects were reported. Minor local reactions were seen in 1.3% of patients. Topical propranolol is safer than oral propranolol, though may be less effective. Topical propranolol may be more suitable for patients with small, superficial haemangiomas at risk of cosmetic sequelae, where the cosmetic or symptomatic impact does not warrant oral propranolol treatment.

Genetic Polymorphisms in Cytokine Genes in Colombian Patients with Ocular Toxoplasmosis.

Toxoplasmosis is caused by infection with the protozoan parasite Toxoplasma gondii, which has the capacity to infect all warm-blooded animals worldwide. Toxoplasmosis is a major cause of visual defects in the Colombian population; however, the association between genetic polymorphisms in cytokine genes and susceptibility to ocular toxoplasmosis has not been studied in this population. This work evaluates the associations between polymorphisms in genes coding for the cytokines tumor necrosis factor alpha (TNF-α) (rs1799964, rs1800629, rs1799724, rs1800630, and rs361525), interleukin 1ß (IL-1ß) (rs16944, rs1143634, and rs1143627), IL-1α (rs1800587), gamma interferon (IFN-γ) (rs2430561), and IL-10 (rs1800896 and rs1800871) and the presence of ocular toxoplasmosis (OT) in a sample of a Colombian population (61 patients with OT and 116 healthy controls). Genotyping was performed with the "dideoxynucleotide (ddNTP) primer extension" technique. Functional-effect predictions of single nucleotide polymorphisms (SNPs) were done by using FuncPred. A polymorphism in the IL-10 gene promoter (-1082G/A) was significantly more prevalent in OT patients than in controls (P = 1.93e-08; odds ratio [OR] = 5.27e+03; 95% confidence interval [CI] = 3.18 to 8.739; Bonferroni correction [BONF] = 3.48e-07). In contrast, haplotype "AG" of the IL-10 gene promoter polymorphisms (rs1800896 and rs1800871) was present at a lower frequency in OT patients (P = 7e-04; OR = 0.10; 95% CI = 0.03 to 0.35). The +874A/T polymorphism of IFN-γ was associated with OT (P = 3.37e-05; OR = 4.2; 95% CI = 2.478 to 7.12; BONF = 6.07e-04). Haplotype "GAG" of the IL-1ß gene promoter polymorphisms (rs1143634, rs1143627, and rs16944) appeared to be significantly associated with OT (P = 0.0494). The IL-10, IFN-γ, and IL-1ß polymorphisms influence the development of OT in the Colombian population.