OAR@UM Collection:

The value of multiple 2D ultrasound scanning views in the detection of congenital heart disease in the second trimester (18 to 24 weeks)

Sun, 01 Jan 2017 00:00:00 GMT

Title: The value of multiple 2D ultrasound scanning views in the detection of congenital heart disease in the second trimester (18 to 24 weeks) Abstract: Introduction: Congenital Heart Disease (CHD) represents the most common type of congenital malformation in the fetus, yet the rate of antenatal detection of CHD is very low. Any improvement in antenatal detection would lead to better prenatal and postnatal care, and may significantly reduce neonatal morbidity and mortality of this condition. Antenatal detection of CHD may be improved by the introduction of additional scanning views to the anomaly 2-Dimensional (2D) ultrasound scan carried out routinely in Malta. The aim of this study was to explore this hypothesis by including additional views in routine local scans. Methods: The population sample included 600 randomly selected women of all ages in their second trimester (from 18 to 24 weeks), who had an elective appointment at the local general hospital (Mater Dei Hospital) for routine antenatal anomaly ultrasound scanning, during the period of July 2014 to June 2015. These women were scanned using (1) the conventional 4 chamber view (4CV), plus additional views, including (2) the left outflow tract, (3) the right outflow tract, (4) the 5-chamber view and (5) the 3-vessel view. The composite scan including a115 views was named the Extended Cardiac Ultrasound Examination (ExCUSE). All views were timed so that an idea of the increased scanning time when implementing these extra views could be garnered. The outcome of the study sample group of mothers that gave birth to neonates with or without CHD was followed up prospectively. The results obtained by the Basic and ExCUSE scanning were then confirmed or refuted clinically after the delivery of the infants. Validity testing, that is, sensitivity and specificity of the 4CV and the ExCUSE views was carried out. This was also done for each and every view to obtain extra information. Lastly, hypothesis testing was performed to confirm whether there was a significant difference between the detection rate of CHD by using the 4CV alone and the detection rate of CHD by ExCUSE scanning or not. Results: During the 12 month study period, that is, between July 2014 and June 2015, there were 61 cases of children of up to 1 year of age who were diagnosed with CHD by Paediatric Echocardiography, of which 19 were part of the study cohort of 600. Of these 19 patients, a diagnosis of some form or other of CHD was made by antenatal scanning in 12 cases, 1 via the 4CV alone, 4 by both the 4CV plus at least 1 of the ExCUSE views and 7 by 1 or more of the ExCUSE views alone (that is, where the 4CV was normal). Furthermore, on average, anomaly scanning that included the ExCUSE views took approximately 6 minutes longer to perform. Hypothesis Testing using the Chi-square test (specifically, McNemar's Test) was carried out and, consequently, the Null Hypothesis was rejected. This meant that there was a significant difference between the detection rate of CHD by the 4CV compared with the ExCUSE views. The sensitivity of the 4CV was found to be 31.6% and its specificity was calculated to be 100%, whilst the sensitivity and specificity of the ExCUSE views were found to be 63.1% and 100%, respectively. Conclusions: Recommendations based on these findings included: a protocol to standardise the approach to the diagnosis of CHD antenatally using additional views to the 4CV; recommendations regarding training in fetal heart scanning; recommendations regarding other and/or new techniques such as the use of Doppler, transvaginal (TV) scanning and 3-Dimensional (3D) Echocardiography; and recommendations regarding workloads that accommodate the increase in scanning time when scanning the fetal heart using the new protocol. Description: PH.D.

Shared care guidelines for patient medicines management in breast and colon cancer

Sun, 01 Jan 2017 00:00:00 GMT

Title: Shared care guidelines for patient medicines management in breast and colon cancer Abstract: The introduction of oral chemotherapy has lead to cancer patients receiving these medications through community pharmacies rather than having to visit a hospital to have their oncology medication administered. This change represents a shift from therapy being given in hospital, to therapy being given in the patient’s own home. In this context, community pharmacists can provide a significant intervention by supporting patients to manage and prevent oral chemotherapy side effects, thus avoiding unwarranted trips to hospital, which saves money and time, resulting in an improvement in the patient’s quality of life. The aim of this research was to compile shared care guidelines for oral chemotherapy used in the management of breast, colon and prostate cancer. Five shared care guidelines were created for: capecitabine, everolimus, abiraterone, enzalutamide and ruxolitinib. The developed documents were validated by a panel of experts consisting of four oncologists, a principal and a senior pharmacist within the compounding section at Mater Dei Hospital, and a senior pharmacist at Sir Anthony Mamo Oncology Hospital. A patient focus group was developed during which five patients receiving oral chemotherapy from a community pharmacy were invited to participate in the focus group and given a questionnaire to capture the patient’s experience about the service received from the community pharmacist. The developed shared care guidelines were presented to community pharmacists during an educational program about managing chemotherapy side effects. Scored questionnaires were handed out to the pharmacists before and after the program to determine if there was an improvement in responses. The validation panel reported on the content and validity of the shared care guidelines developed. The educational program was carried out for 11 community pharmacists who are currently practicing in community pharmacies where dispensing of oncology oral therapy is undertaken. The mean response rate before the educational program was 5.45% whilst the mean response rate after the program was 80%. From the patient focus group issues related to information presented to the patient about what side effects to be expected, how these side effects should be handled and how these medications should be stored were identified. These points were used to develop the framework for the shared care guidelines and each guideline now consists of indications, administration, side effects and storage information. The shared care guidelines were developed within a collaborative framework and are intended to further substantiate effective communication between healthcare professionals at different settings, namely: the hospital multidisciplinary team and the community pharmacist dispensing the oral chemotherapy drugs. Description: PharmD

Detecting signals of electrocardiogram QT prolongation and QT shortening : regulatory implications

Sun, 01 Jan 2017 00:00:00 GMT

Title: Detecting signals of electrocardiogram QT prolongation and QT shortening : regulatory implications Abstract: Drug-induced changes to the conductivity of the human ether-a-go-go related gene (hERG) potassium channels, affect cardiac repolarisation and put patients at risk of fatal cardiac arrhythmias such as Torsade de Pointes. Healthcare professionals and patients benefit from knowing which medicinal products cause this adverse event, in order to minimise co-prescribing of such drugs or to carry out appropriate monitoring. The aim of this study was to detect and characterize the QT change liability of authorised medicinal products. The methodology was in two parts. Study 1 involved extracting signals from the Eudravigilance database, and in study 2 an in-depth assessment of unexpected signals through review of literature, preclinical, adverse drug reaction and clinical trial data was performed. Proportional reporting ratios were used to identify statistical associations between drugs and QT change and expectedness was checked through the product information (PI). A list for the frequency of expectedness was created. Drugs not expected to cause QT changes were evaluated within the Bradford Hill criteria for association. Four hundred and seventeen candidates with a potential signal of QT modulation were identified. Of these, 12 products did not have QT change as an expected adverse event and so were assessed. Results from the assessment showed that changes to the PI of mirabegron, asenapine and pantoprazole could be warranted and signals on QT prolongation for mirabegron and asenapine were reported to the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC). In March 2017, the PRAC rapporteurs for these active substances (Spain and United Kingdom) agreed to take regulatory action and update the SPCs within the next periodic safety review procedures, starting in quarter four 2017. For pantoprazole, an emergent signal of hypokalaemia may warrant further separate investigation. For QT shortening, fingolimod and olanzapine were assessed, and the data for these two drugs did not lead to a recommendation for change to the PI due to lack of robust evidence. In conclusion, this study presents a number of outputs; (1) inferences on (a) mirabegron, (b) asenapine and (c) pantoprazole, (2) assessment recommendations for preclinical assessors and marketing authorisation holders looking at hERG studies, (3) reflections on the pharmacological basis of short QT, and (4) an innovative proposal for a QT drugs list with risk categorisation. Description: PharmD

Patient-centred monitoring in chronic disease management in the community pharmacy

Sun, 01 Jan 2017 00:00:00 GMT

Title: Patient-centred monitoring in chronic disease management in the community pharmacy Abstract: Chronic diseases present a number of challenges for healthcare systems worldwide. Community pharmacists are in a unique position to participate in the chronic care of their patients through patient monitoring and medication management. The aim of this research was to evaluate the impact of a pharmacist-led chronic disease management service by identifying drug-related problems (DRPs) and assessing the pharmacist intervention on patient health outcomes. A chronic disease management service was implemented in a community pharmacy. Fifty patients taking at least one chronic medication were recruited. Two medication review sessions were held; an initial session and a follow-up session after 4 months. During the sessions, point-of-care testing for blood pressure, blood glucose and HbA1c monitoring as well as lifestyle advice were provided. A pharmaceutical care plan with recommendations to solve DRPs was developed for each patient. Forty-eight patients completed the study, with a mean age of 69 years and taking an average of 5 medications daily. A total of 207 DRPs were identified with a mean of 4.25 DRPs per patient, which mainly involved undertreatment (18.8%), monitoring (18.4%) and compliance (17.9%) issues. Most DRPs were solved (78.6%) or partially solved (16.5%). Following the pharmacist intervention, there was a decrease in systolic blood pressure by 10mmHg (p<0.001), diastolic blood pressure by 4mmHg (p=0.001), fasting blood glucose by 1.7mmol/L (p<0.001) and HbA1c level by 0.5% (p<0.001). Medication compliance improved from a mean score of 17.7 to 21.7 out of a total score of 25 (p<0.001) and patient satisfaction increased from a mean score of 2.61 to 4.11 after intervention out of a total score of 5 (p<0.001). The patient-centred monitoring service had a significant positive impact, suggesting that expanding the role of community pharmacists in chronic disease management can improve patient health outcomes. Description: PharmD