METHODS: We built two models, for ER+ (ModelER+) and ER- tumors (ModelER-), respectively, in 281,330 women (51% postmenopausal at recruitment) from the European Prospective Investigation into Cancer and Nutrition cohort. Discrimination (C-statistic) and calibration (the agreement between predicted and observed tumor risks) were assessed both internally and externally in 82,319 postmenopausal women from the Women's Health Initiative study. We performed decision curve analysis to compare ModelER+ and the Gail model (ModelGail) regarding their applicability in risk assessment for chemoprevention.
RESULTS: Parity, number of full-term pregnancies, age at first full-term pregnancy and body height were only associated with ER+ tumors. Menopausal status, age at menarche and at menopause, hormone replacement therapy, postmenopausal body mass index, and alcohol intake were homogeneously associated with ER+ and ER- tumors. Internal validation yielded a C-statistic of 0.64 for ModelER+ and 0.59 for ModelER-. External validation reduced the C-statistic of ModelER+ (0.59) and ModelGail (0.57). In external evaluation of calibration, ModelER+ outperformed the ModelGail: the former led to a 9% overestimation of the risk of ER+ tumors, while the latter yielded a 22% underestimation of the overall BC risk. Compared with the treat-all strategy, ModelER+ produced equal or higher net benefits irrespective of the benefit-to-harm ratio of chemoprevention, while ModelGail did not produce higher net benefits unless the benefit-to-harm ratio was below 50. The clinical applicability, i.e. the area defined by the net benefit curve and the treat-all and treat-none strategies, was 12.7 × 10- 6 for ModelER+ and 3.0 × 10- 6 for ModelGail.
CONCLUSIONS: Modeling heterogeneous epidemiological risk factors might yield little improvement in BC risk prediction. Nevertheless, a model specifically predictive of ER+ tumor risk could be more applicable than an omnibus model in risk assessment for chemoprevention.
METHODS/DESIGN: The study will be a prospective randomized controlled trial comparing an intensive tobacco-related education program versus non-tobacco-related training on pharmacists' tobacco-use-related knowledge, attitudes, self-efficacy, and skills. Community pharmacists practicing in Qatar will be eligible for participation in the study. A random sample of pharmacists will be selected for participation. Consenting participants will be randomly allocated to intervention or control groups. Participants in the intervention group will receive an intensive education program delivered by a multi-disciplinary group of educators, researchers, and clinicians with expertise in tobacco cessation. A short didactic session on a non-tobacco-related topic will be delivered to pharmacists in the control group. The study has two primary outcomes: post-intervention tobacco-related knowledge and post-intervention skills for tobacco cessation assessed using a multiple-choice-based evaluation instrument and an Objective Structured Clinical Examination (OSCE), respectively. The secondary study outcomes are post-intervention attitudes towards tobacco cessation and self-efficacy in tobacco-cessation interventions assessed using a survey instrument. An additional secondary study outcome is the post-intervention performance difference in relation to tobacco-cessation skills in the practice setting assessed using the simulated client approach.
DISCUSSION: If demonstrated to be effective, this education program will be considered as a model that Qatar and the Middle East region can apply to overcome the burden of tobacco-use disorder.
TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03518476 . Registered on 8 May 2018. Version 1/22 June 2018.
OBJECTIVE: The objectives of this article are to discuss the recent progress in the development of new vaccines against TB; to provide an insight on the mechanism of vaccine-mediated specific immune response stimulation, and to debate on the interaction between vaccines and global interventions to end TB.
METHODS AND ANALYSIS: The study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.
ETHICS AND DISSEMINATION: The study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER: NCT03177031; Pre-results.
DESIGN/METHODOLOGY/APPROACH: The authors conducted a gap analysis on recommended practices gathered from the literature and current practices gathered through semi-structured interviews with Malaysian medical personnel. A life cycle approach was adopted covering mercury use: input, storage, handling, accident, waste disposal and governance phases.
FINDINGS: The authors found that there are significant gaps between recommended and current mercury management practices. Analysis indicates improper mercury management as the main contributor to these gaps. The authors found from recommended practices that core components needing improvement include: mercury management action plan, mercury use identification team, purchasing policy, proper guidelines and monitoring systems.
PRACTICAL IMPLICATIONS: This study helps us to understand mercury management practices and suggests essential steps to establish a mercury-free medical facility.
ORIGINALITY/VALUE: This study explored the gaps between recommended and current mercury management practices in a medical facility and contributes to the Minamata Convention on Mercury aspirations.
OBJECTIVE: To evaluate the impact of antibiotic stewardship interventions on compliance with surgical antibiotic prophylaxis practice in obstetrics and gynecology surgeries.
METHOD: A prospective pre- and post-intervention study was conducted in two tertiary hospitals between May and December 2016. The duration of the each period was 3 months. Antibiotic stewardship interventions including development of a protocol, educational meeting and audit and feedback were implemented. Data were collected using the patient records and analyzed with SPSS version 23.
RESULTS: A total of 226 and 238 surgical procedures were included in the pre- and post-intervention periods respectively. Age, length of stay and estimated blood loss were similar between the two groups. However, specialty and surgical procedures varied significantly. There was a significant increase in compliance with timing (from 14.2% to 43.3%) and duration (from 0% to 21.8%) of surgical antibiotic prophylaxis after the interventions. The interventions significantly reduced the prescription of third generation cephalosporin (-8.6%), redundant antibiotic (-19.1%), antibiotic utilization (-3.8 DDD/procedure) and cost of antibiotic prophylaxis (-$4.2/procedure). There was no significant difference in the rate of surgical site infection between the two periods. Post-intervention group (OR: 5.60; 95% CI: 3.31-9.47), elective surgery (OR: 4.62; 95% CI: 2.51-8.47) and hospital attended (OR: 9.89; 95% CI: 5.66-17.26) were significant predictors of compliance with timing while elective surgery (OR: 12.49; 95% CI: 2.85-54.71) and compliance with timing (OR: 58.55; 95% CI: 12.66-270.75) were significantly associated with compliance to duration of surgical antibiotic prophylaxis.
CONCLUSION: The interventions improve compliance with surgical antibiotic prophylaxis and reduce antibiotic utilization and cost. However, there is opportunity for further improvement, particularly in non-elective surgical procedures.
OBJECTIVES: The aim of this study was to look at our intermediate outcomes after LDJB-SG.
SETTING: An academic medical center.
METHODS: A prospective analysis of T2D patients who underwent LDJB-SG between October 2011 and October 2014 was performed. Data collected included baseline demographic, body mass index, fasting blood glucose, glycosylated hemoglobin, C-peptide, resolution of co-morbidities, and postoperative complications.
RESULTS: A total of 163 patients with minimum of follow-up >1 year were enrolled in this study (57 men and 106 women). The mean age and body mass index were 47.7 (±10.7) years and a 30.2 (±5.1) kg/m2, respectively. There were 119 patients on oral hypoglycemic agents only, 29 patients were on oral hypoglycemic agents and insulin, 3 patients were on insulin only, and the other 12 patients were not on diabetic medication. Mean operation time and length of hospital stay were 144.7 (± 45.1) minutes and 2.4 (± 1.0) days, respectively. Seven patients (3.6%) needed reoperation due to bleeding (n = 1), anastomotic leak (n = 2), sleeve strictures (n = 2), and incisional hernia (n = 2). At 2 years of follow-up, there were 56 patients. None of the patients were on insulin and only 20% of patients were on oral hypoglycemic agents. Mean body mass index significantly dropped to 22.9 (±5.6) kg/m2 at 2 years. The mean preoperative fasting blood glucose, glycosylated hemoglobin, and C-peptide levels were 174.7 mg/dL (± 61.0), 8.8% (±1.8), and 2.6 (±1.7) ng/mL, respectively. The mean fasting blood glucose, glycosylated hemoglobin, and C-peptide at 2 years were 112.5 (±60.7) mg/dL, 6.4% (±2.0), and 1.5 (±0.6) ng/mL, respectively. No patient needed revisional surgery because of dumping syndrome, marginal ulcer, or gastroesophageal reflux disease at the last follow up period.
CONCLUSION: At 2 years, LDJB-SG is a relatively safe and effective metabolic surgery with significant weight loss and resolution of co-morbidities.
METHODS: In 567 adult participants planned for AVF creation, all were randomised to fish oil (4g/d) or placebo, and 406 to aspirin (100mg/d) or placebo, starting one day pre-surgery and continued for three months. Outcomes evaluated within 12 months included AVF intervention rates, CVC exposure, late dialysis suitability failure, and times to primary patency loss, abandonment and successful cannulation.
RESULTS: Final analyses included 536 participants randomised to fish oil or placebo (mean age 55 years, 64% male, 45% diabetic) and 388 randomised to aspirin or placebo. Compared with placebo, fish oil reduced intervention rates (0.82 vs 1.14/1000 patient-days, incidence rate ratio [IRR] 0.72, 95% confidence interval [CI] 0.54-0.97), particularly interventions for acute thrombosis (0.09 vs 0.17/1000 patient-days, IRR 0.53, 95% CI 0.34-0.84). Aspirin significantly reduced rescue intervention rates (IRR 0.45, 95% CI 0.27-0.78). Neither agent significantly affected CVC exposure, late dialysis suitability failure or time to primary patency loss, AVF abandonment or successful cannulation.
CONCLUSION: Although fish oil and low-dose aspirin given for 3 months reduced intervention rates in newly created AVF, they had no significant effects on CVC exposure, AVF usability and time to primary patency loss or access abandonment. Reduction in access interventions benefits patients, reduces costs and warrants further study.
METHODS: The study consisted of two phases. In Phase 1, a 10-item instrument (SAIL-10) was developed and tested on a cohort of medical and pharmacy students who attended the workshop. In Phase 2, different cohorts of medical and pharmacy students completed SAIL-10 before and after participating in the workshop.
RESULTS: Factor analysis showed that SAIL-10 has two domains: "facilitators of interprofessional learning" and "acceptance to learning in groups". The overall SAIL-10 and the two domains have adequate internal consistency and stable reliability. The total score and scores for the two domains were significantly higher after students attended the prescribing skills workshop.
CONCLUSIONS: This study produced a valid and reliable instrument, SAIL-10 which was used to demonstrate that the prescribing skills workshop, where medical and pharmacy students were placed in an authentic context, was a promising activity to promote interprofessional learning among future healthcare professionals.
Biofouling is a phenomenon that describes the fouling organisms attached to man-made surfaces immersed in water over a period of time. It has emerged as a chronic problem to the oceanic industries, especially the shipping and aquaculture fields. The metal-containing coatings that have been used for many years to prevent and destroy biofouling are damaging to the ocean and many organisms. Therefore, this calls for the critical need of natural product-based antifoulants as a substitute for its toxic counterparts. In this study, the antibacterial and antibiofilm activities of the bioactive compounds of Pseudoalteromonas sp. IBRL PD4.8 have been investigated against selected fouling bacteria. The crude extract has shown strong antibacterial activity against five fouling bacteria, with inhibition zones ranging from 9.8 to 13.7 mm and minimal inhibitory concentrations of 0.13 to 8.0 mg/ml. Meanwhile, the antibiofilm study has indicated that the extract has attenuated the initial and pre-formed biofilms of Vibrio alginolyticus FB3 by 45.37 ± 4.88% and 29.85 ± 2.56%, respectively. Moreover, micrographs from light and scanning electron microscope have revealed extensive structural damages on the treated biofilms. The active fraction was fractionated with chromatographic methods and liquid chromatography-mass spectroscopy analyses has further disclosed the presence of a polyunsaturated fatty acid 4,7,10,13-hexadecatetraenoic acid (C16H24O2). Therefore, this compound was suggested as a potential bioactive compound contributing to the antibacterial property. In conclusion, Pseudoalteromonas sp. IBRL PD4.8 is a promising source as a natural antifouling agent that can suppress the growth of five fouling bacteria and biofilms of V. alginolyticus FB3.
KEY FINDINGS: Among ARVs, the most common drugs employed from the class of entry inhibitors are maraviroc (MVC), which is a CCR5 receptor antagonist. Other entry inhibitors like emtricitabine (FTC) and tenofovir (TFV) are also used. Rilpivirine (RPV) and dapivirine (DPV) are the most common drugs employed from the Non-nucleoside reverse transcriptase inhibitor (NNRTIs) class, whereas, tenofovir disoproxil fumarate (TDF) is primarily used in the Nucleoside Reverse Transcriptase Inhibitor (NRTIs) class. Cabotegravir (CAB) is an analog of dolutegravir, and it is an integrase inhibitor. Some of these drugs are also used in combination with other drugs from the same class.
SUMMARY: Some of the most common pre-exposure prophylactic strategies employed currently are the use of inhibitors, namely entry inhibitors, non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors, integrase and protease inhibitors. In addition, we have also discussed on the adverse effects caused by ART in PrEP, pharmacoeconomics factors and the use of antiretroviral prophylaxis in serodiscordant couples.