Barriers to the success of an electronic pharmacovigilance reporting system in Kenya: an evaluation three years post implementation.

Objective: Electronic pharmacovigilance reporting systems are being implemented in many developing countries in an effort to improve reporting rates. This study sought to establish the factors that acted as barriers to the success of an electronic pharmacovigilance reporting system in Kenya 3 years after its implementation. Materials and Methods: Factors that could act as barriers to using electronic reporting systems were identified in a review of literature and then used to develop a survey questionnaire that was administered to pharmacists working in government hospitals in 6 counties in Kenya. Results: The survey was completed by 103 out of the 115 targeted pharmacists (89.5%) and included free-text comments. The key factors identified as barriers were: unavailable, unreliable, or expensive Internet access; challenges associated with a hybrid system of paper and electronic reporting tools; and system usability issues. Coordination challenges at the national pharmacovigilance center and changes in the structure of health management in the country also had an impact on the success of the electronic reporting system. Discussion: Different personal, organizational, infrastructural, and reporting system factors affect the success of electronic reporting systems in different ways, depending on the context. Context-specific formative evaluations are useful in establishing the performance of electronic reporting systems to identify problems and ensure that they achieve the desired objectives. Conclusion: While several factors hindered the optimal use of the electronic pharmacovigilance reporting system in Kenya, all were considered modifiable. Effort should be directed toward tackling the identified issues in order to facilitate use and improve pharmacovigilance reporting rates.

Relationship between interstitial and blood glucose during hypoglycemia in subjects with type 2 diabetes.

BACKGROUND: Continuous glucose monitoring devices measure interstitial glucose and are commonly used to investigate hypoglycemia. The relationship between interstitial glucose and blood glucose is not completely understood, particularly at low blood glucose concentrations. Interstitial glucose during hypoglycemia is generally lower than blood glucose in young subjects without diabetes and those with type 1 diabetes, but the effect of insulin resistance and obesity in type 2 diabetes on this relationship has not been examined previously. We studied the relationship between blood and interstitial glucose during experimental hypoglycemia in subjects with type 2 diabetes treated with insulin or sulfonylureas and matched controls without diabetes. METHODS: Twenty subjects with type 2 diabetes (10 sulfonylurea-treated and 10 insulin-treated) and 10 controls without diabetes of similar age and weight underwent stepped hyperinsulinemic hypoglycemic clamps. We compared blood and interstitial glucose at different levels of hypoglycemia using random effects modeling. RESULTS: Interstitial glucose was significantly higher than blood glucose at all levels of hypoglycemia (P<0.001), and this difference increased as glucose fell. For every 1 mmol/L drop in blood glucose, the difference increased by 0.32 mmol/L (P<0.001). This difference was not affected by presence of type 2 diabetes or by modality of treatment (P=0.10). CONCLUSIONS: In older subjects with or without type 2 diabetes, interstitial glucose is significantly higher than blood glucose, and this difference increases with increasing severity of hypoglycemia. Continuous glucose monitors may underestimate hypoglycemia in this group, and this should be taken into account when interpreting results obtained using this technology.

The impact of the 4 h target on patient care and outcomes in the Emergency Department: an analysis of hospital incidence data.

BACKGROUND: Recent government initiatives in the NHS have seen patient care becoming increasingly target-driven. However, the impact of targets, particularly those based on a timeframe, have not been extensively studied, and concerns remain about unintended consequences for patients. The aim of this study was to evaluate the effect of a 4 h target in the Emergency Department (ED) on patient care and outcomes. METHODS: The study comprised an interrupted time-series regression analysis of anonymised patient-level data from 580,000 new patient episodes in the ED between April 2000 and Feb 2006. Outcomes were time in ED, time to clinician, mortality, admission and reattendance rates, and number of investigations. RESULTS: 90% target was associated with reductions in time in department and fewer patients admitted for less than 24 and 48 h, and a slight increase in the number reattending within 7 days. 98% target was associated with levelling-off of time in department and reductions in numbers admitted and reattending within 7 days. Neither target was associated with change in time to clinician. The introduction of a minor injuries unit (MIU) was associated with reductions in time to clinician and percentage not waiting, and increases in number of investigations, percentages admitted, admitted for 24 h and reattendances within 7 days. Mortality was unaffected by either target or MIU. CONCLUSION: Although time target introduction is associated with changes in patient care, the introduction of a co-located MIU had greater impact.

Innovations in curriculum design: a multi-disciplinary approach to teaching statistics to undergraduate medical students.

BACKGROUND: Statistics is relevant to students and practitioners in medicine and health sciences and is increasingly taught as part of the medical curriculum. However, it is common for students to dislike and under-perform in statistics. We sought to address these issues by redesigning the way that statistics is taught. METHODS: The project brought together a statistician, clinician and educational experts to re-conceptualize the syllabus, and focused on developing different methods of delivery. New teaching materials, including videos, animations and contextualized workbooks were designed and produced, placing greater emphasis on applying statistics and interpreting data. RESULTS: Two cohorts of students were evaluated, one with old style and one with new style teaching. Both were similar with respect to age, gender and previous level of statistics. Students who were taught using the new approach could better define the key concepts of p-value and confidence interval (p < 0.001 for both). They were more likely to regard statistics as integral to medical practice (p = 0.03), and to expect to use it in their medical career (p = 0.003). There was no significant difference in the numbers who thought that statistics was essential to understand the literature (p = 0.28) and those who felt comfortable with the basics of statistics (p = 0.06). More than half the students in both cohorts felt that they were comfortable with the basics of medical statistics. CONCLUSION: Using a variety of media, and placing emphasis on interpretation can help make teaching, learning and understanding of statistics more people-centred and relevant, resulting in better outcomes for students.

Monitoring infant weight gain: advice for practitioners.

It is current practice in the UK to include growth reference charts in the Personal Child Health Records. This has the potential to lead to frequent measurement of weight. While this can reassure parents and professionals alike, it can also lead to stress and anxiety if the child is not perceived to be gaining weight. 'Health for all Children' states that the 'interpretation of growth measurements requires skill and judgement, and is easier when several measurements are taken over a period of time'. This article aims to give healthcare professionals the information to be able to do this. It outlines best practice for weight monitoring of babies in the first year of life, according to current evidence, and offers a flowchart detailing the points to consider when assessing infant weight gain.

Psychological morbidity after myocardial infarction in an area of deprivation in the UK: evaluation of a self-help package.

BACKGROUND: Psychological morbidity after an acute myocardial infarction (AMI) is known to be common, but can be addressed by appropriate rehabilitation. The area in which this research was conducted experiences high rates of deprivation and of coronary heart disease and limited access to hospital-based rehabilitation. Responding to concern about psychological needs of AMI patients, a self-help package was introduced and evaluated alongside standard hospital-based cardiac rehabilitation. AIMS: To evaluate the impact of a home-based self-help package (the Heart Manual), alongside existing cardiac rehabilitation provision, on psychological morbidity and health status after AMI. A secondary aim was to assess the suitability of the Heart Manual for older patients aged over 80 years. METHODS: A controlled observational study, comparing two cohorts of patients discharged from hospital after AMI. The intervention group was given the self-help package in addition to standard care. The control group received standard care alone. Outcome measures used were the Hospital Anxiety and Depression Scale and the EuroQol. RESULTS: The intervention group showed significant improvement in anxiety and depression scores after 3 months and nonsignificant improvement in general health status. Patients who attended hospital-based rehabilitation classes, and those aged over 80 years, also benefited from the intervention. CONCLUSION: A home-based self-help rehabilitation package is an effective tool alongside hospital-based rehabilitation classes and can be given to all age groups.