Effects of training physicians in electronic prescribing in the outpatient setting on clinical, learning and behavioural outcomes: a cluster randomized trial.

AIMS: Electronic prescribing systems may improve medication safety, but only when used appropriately. The effects of task analysis-based training on clinical, learning and behavioural outcomes were evaluated in the outpatient setting, compared with the usual educational approach. METHODS: This was a multicentre, cluster randomized trial [EDUCATional intervention for IT-mediated MEDication management (MEDUCATE trial)], with physicians as the unit of analysis. It took place in the outpatient clinics of two academic hospitals. Participants comprised specialists and residents (specialty trainees, in the UK) and their patients. Training took the form of a small-group session and an e-learning. The primary outcome was the proportion of medication discrepancies per physician, measured as discrepancies between medications registered by physicians in the electronic prescribing system and those reported by patients. Clinical consequences were estimated by the proportion of patients per physician with at least one missed drug-drug interaction with the potential for causing adverse drug events. A questionnaire assessed physicians' knowledge and skills. RESULTS: Among 124 participating physicians, primary outcome data for 115 (93%) were available. A total of 1094 patients were included. A mean of 48% of registered medications per physician were discrepant with the medications that their patients reported in both groups (P = 0.14). Due to registration omissions, a mean of 4% of patients per physician had one or more missed drug-drug interactions with the potential to cause a clinically relevant adverse drug event in the intervention group, and 7% in controls (P = 0.11). The percentages of correct answers on the knowledge and skills test were higher in the intervention group (57%) compared with controls (51%; P = 0.01). CONCLUSION: The training equipped outpatient physicians with the knowledge and skills for appropriate use of electronic prescribing systems, but had no effect on medication discrepancies.

[Improve, but measure in moderation; quality management in specialty residency training]. / Verbeter, maar meet met mate.

Intuitively, we believe we gain knowledge through taking measurements, and our appetite for quality measurement in general has grown spectacularly. However, this approach has to be qualified. Many aspects of quality are difficult to measure, yet are very important, and choosing what to measure may be heavily influenced by the availability bias of instruments. Moreover, a lot can be known without actually measuring. Quantitative results tend to offer false reassurance simply by their abundance, and results presented by means of Likert scales may obscure the crucial critique of a minority of respondents. Narrative comments in surveys are often much more meaningful as they can foster an open dialogue between residents and their clinical teachers, preferably led by a neutral chairperson. Contrary to what is often claimed, it is even possible to engage in improvement without prior measurement. I propose measuring only in moderation and instead devoting time and money to patient care and educating residents, and on the design and execution of improvement plans.

MEDUCATE trial: effectiveness of an intensive EDUCATional intervention for IT-mediated MEDication management in the outpatient clinic - study protocol for a cluster randomized controlled trial.

BACKGROUND: Using information technology for medication management is an opportunity to help physicians to improve the quality of their documentation and communication and ultimately to improve patient care and patient safety. Physician education is necessary to take full advantage of information technology systems. In this trial, we seek to determine the effectiveness of an intensive educational intervention compared with the standard approach in improving information technology-mediated medication management and in reducing potential adverse drug events in the outpatient clinic. METHODS/DESIGN: We are conducting a multicenter, cluster randomized controlled trial. The participants are specialists and residents working in the outpatient clinic of internal medicine, cardiology, pulmonology, geriatrics, gastroenterology and rheumatology. The intensive educational intervention is composed of a small-group session and e-learning. The primary outcome is discrepancies between registered medication (by physicians) and actually used medication (by patients). The key secondary outcomes are potential adverse events caused by missed drug-drug interactions. The primary and key secondary endpoints are being assessed shortly after the educational intervention is completed. Sample size will be calculated to ensure sufficient power. A sample size of 40 physicians per group and 20 patients per physician will ensure a power of >90 %, which means we will need a total of 80 physicians and 1,600 patients. DISCUSSION: We performed an exploratory trial wherein we tested the recruitment process, e-learning, time schedule, and methods for data collection, data management and data analysis. Accordingly, we refined the processes and content: the recruitment strategy was intensified, extra measures were taken to facilitate smooth conductance of the e-learning and parts were made optional. First versions of the procedures for data collection were determined. Data entry and analysis was further standardized by using the G-standard database in the telephone questionnaire. TRIAL REGISTRATION: ISRCTN registry: ISRCTN50890124 . Registered 10 June 2013.

Task analysis of information technology-mediated medication management in outpatient care.

AIMS: Educating physicians in the procedural as well as cognitive skills of information technology (IT)-mediated medication management could be one of the missing links for the improvement of patient safety. We aimed to compose a framework of tasks that need to be addressed to optimize medication management in outpatient care. METHODS: Formal task analysis: decomposition of a complex task into a set of subtasks. First, we obtained a general description of the medication management process from exploratory interviews. Secondly, we interviewed experts in-depth to further define tasks and subtasks. SETTING: Outpatient care in different fields of medicine in six teaching and academic medical centres in the Netherlands and the United States. PARTICIPANTS: 20 experts. Tasks were divided up into procedural, cognitive and macrocognitive tasks and categorized into the three components of dynamic decision making. RESULTS: The medication management process consists of three components: (i) reviewing the medication situation; (ii) composing a treatment plan; and (iii) accomplishing and communicating a treatment and surveillance plan. Subtasks include multiple cognitive tasks such as composing a list of current medications and evaluating the reliability of sources, and procedural tasks such as documenting current medication. The identified macrocognitive tasks were: planning, integration of IT in workflow, managing uncertainties and responsibilities, and problem detection. CONCLUSIONS: All identified procedural, cognitive and macrocognitive skills should be included when designing education for IT-mediated medication management. The resulting framework supports the design of educational interventions to improve IT-mediated medication management in outpatient care.

[Full clinical placements for medical students can start as early as the third year of medical training]. / Volwaardige coassistentschappen kunnen al in het derde studiejaar beginnen.

The undergraduate medical curriculum in Utrecht provides students with early clinical experience in their third year by two full clinical placements in general medical areas. With this, an optimum context for the integration of biomedical knowledge is achieved. The doctor in training gains experience in an authentic setting as early as possible in the medical education programme with modern opinions on professionalism that fit in with current societal requirements.

Macrosomia despite good glycaemic control in Type I diabetic pregnancy; results of a nationwide study in The Netherlands.

AIMS/HYPOTHESIS: To investigate the incidence of foetal macrosomia (i.e. birth weight >90th percentile) in a non-selected nationwide cohort of women with Type I (insulin-dependent) diabetes mellitus in The Netherlands and to identify risk indicators predictive for macrosomia. METHODS: We conducted a prospective nationwide cohort based survey regarding the outcome of Type I diabetic pregnancy in The Netherlands. Data of 289 women who gave birth to a live singleton infant without major congenital malformations at more than or equal to 28 weeks of gestation are shown. RESULTS: The incidence of foetal macrosomia was very high (48.8%), with 26.6% of infants weighing more than 97.7th percentile. Glycaemic control during pregnancy was good (i.e. mean HbA(1c)

Clinical characteristics of type 1 diabetic patients with and without severe hypoglycemia.

OBJECTIVE: To investigate the frequency of severe hypoglycemia (SH) and hypoglycemic coma and to identify clinical and behavioral risk indicators in a nonselected population of type 1 diabetic patients. RESEARCH DESIGN AND METHODS: This study involved a retrospective clinical survey of 195 consecutive patients using a questionnaire addressing the frequency of SH (i.e., help from others required) and hypoglycemic coma during the previous year, general characteristics, behavior, hypoglycemia awareness, and the Hypoglycemia Fear Survey Data regarding diabetes, treatment, long-term complications, comorbidity, and comedication were obtained from the patients' medical records. RESULTS: A total of 82% of subjects were receiving intensive insulin treatment, and mean +/- SD HbA(1c) was 7.8 +/- 1.2%. Mean duration of diabetes was 20 +/- 12 years. The occurrence of SH (including hypoglycemic coma) was 150 episodes/100 patient-years and affected 40.5% of the population. Hypoglycemic coma occurred in 19% of subjects (40 episodes/100 patient-years). SH without coma was independently related to nephropathy (odds ratio [OR] 4.8 [95% CI 1.5-15.1]), a threshold for hypoglycemic symptoms of <3 mmol/l (4.8 [1.8-12.0]), and a daily insulin dose 0.1 U/kg higher (1.3 [1.0-1.6]) (all ORs were adjusted for diabetes duration and use of comedication). Hypoglycemic coma was independently related to neuropathy (3.9 [1.5-10.4]), (nonselective) beta-blocking agents (14.9 [2.1-107.4]), and alcohol use (3.5 [1.3-9.1]) (all ORs were adjusted for diabetes duration). CONCLUSIONS: SH and hypoglycemic coma are common in a nonselected population with type 1 diabetes. The presence of long-term complications, a threshold for symptoms of <3 mmo/l, alcohol use, and (nonselective) beta-blockers were associated with SH during the previous year. If prospectively confirmed, these results may have consequences for clinical practice.

[Diabetic ketoacidosis presenting as acute abdomen]. / Wanneer diabetische ketoacidose zich manifesteert als acute buik.

Three patients, two women aged 21 and 67 and a man aged 43 years, presented at the emergency department with diabetic ketoacidosis and abdominal symptoms mimicking an acute abdominal condition. In two of them laparotomy was performed which proved to be negative. Abdominal symptoms resolved after correction of metabolic, fluid and electrolyte disturbances. Symptoms indicating a possible diagnosis of acute abdomen have to be regarded as being compatible with diabetic ketoacidosis per se. However, a potential acute abdominal problem prompting surgical intervention should not be overlooked; it may have been the precipitating factor for diabetic ketoacidosis.

A diagnostic advice system based on pathophysiological models of diseases.

Medical decision-support systems in which uncertainty plays an essential role are increasingly based on the formalism of probabilistic networks. Although this formalism is very powerful, the construction of actual networks is not straightforward, and requires the availability of clearly structured medical domain models as a starting point. In this paper it is argued that medical pathophysiological knowledge constitutes a good start for the development of such models, even though pathophysiological knowledge is semantically different from probabilistic knowledge. Two models concerning anaemia, which are part of a broad system covering the domain of anaemia, are discussed to illustrate the general approach.

A development protocol for a diagnostic DSS.

A diagnostic decision support system (DSS) in medicine is an expert system that aids the physician in the determination of the diagnosis based on findings and test results. The DSS can be divided into 2 different types of components: the knowledge component and the information system component. Methods from software engineering, knowledge engineering and management are combined into a dynamic development cycle that allows stepwise update and refinement. The development of the knowledge component is based on knowledge engineering. In the starting phases, rapid prototyping is convenient to determine and evaluate the specification. The content of the knowledge base is frequently updated during its life time. For this purpose, a knowledge modelling protocol is supplied.

The high alkaline fraction on isoelectric focusing of cerebrospinal fluid is cystatin C.

A high alkaline fraction with a pI of 9.2 is sometimes seen on isoelectric focusing patterns of cerebrospinal fluid. The appearance of this fraction mainly depends on the type of concentrators used to prepare the cerebrospinal fluid samples, prior to isoelectric focusing. The amino acid sequence of the high alkaline fraction showed sequence identity to cystatin C, a cysteine protease inhibitor with a pI of 9.2-9.3 and a molecular mass of 13.4 kDa. In addition, on Western blot the high alkaline fraction was recognized by an antibody, directed against cystatin C. Taken together, the present findings demonstrate that the high alkaline fraction is cystatin C.

Injection site effects on the pharmacokinetics and glucodynamics of insulin lispro and regular insulin.

OBJECTIVE: The pharmacokinetics and glucodynamics of a new insulin analog, insulin lispro, and regular human insulin were compared and contrasted after subcutaneous administrations in femoral, deltoid, and abdominal injection sites. RESEARCH DESIGN AND METHODS: Single 0.2 U/kg doses of insulin lispro and regular insulin were administered to 12 healthy subjects in a six-way randomized crossover fashion. Each dose was given after an overnight fast in one of three injection sites: abdominal, deltoid, or femoral. Study drugs were given during a manual euglycemic glucose clamp. Blood samples were collected over the 12-h clamp for measurement of insulin-reactive components, with pharmacokinetic and glucodynamic measurements derived from these serum insulin and clamp measurements. RESULTS: Glucodynamic comparisons between insulin lispro and regular insulin showed a greater maximum infusion rate (Rmax) at an earlier time (TRmax), regardless of injection site. The total glucose infused (Gtot) showed nearly identical values between sites for insulin lispro. Regular insulin showed greater Gtot values from deltoid and femoral injections. When comparisons were made between drugs, regular insulin produced significantly greater Gtot, primarily driven by the increased Gtot from deltoid and femoral injections. Greater maximum serum insulin concentrations (Cmax) were experienced with insulin lispro at earlier times (tmax), regardless of the injection site (P < 0.001). Abdominal administrations produced the greatest Cmax values at the earliest tmax for both regular insulin and insulin lispro. Deltoid and femoral injections had lower Cmax values for both compounds. Shifts also occurred with tmax, although these shifts were much greater with regular insulin than with insulin lispro. Equivalent area under the curve (AUC) values were found when compared between compounds. CONCLUSIONS: Slower absorption from deltoid and femoral administrations resulted in an increased duration of action for both regular insulin and insulin lispro when compared to abdominal administration. However, notable increases in the onset of action were only apparent with regular insulin. The consistency with insulin lispro response from abdominal and extremity injection sites allows more potential sites for subcutaneous injection with an assured rapid response.

[Sexual violence observed in family practice]. / Seksueel geweld waargenomen in de huisartspraktijk.

In 11 general medical practices which are part of the 'Huisartsen Peilstation Groningen', the nature and extent were investigated of cases of sexual violence previously unknown to the GP. Questions also investigated were who took the initiative to bringing up this subject, and whether the results yield guidelines for better detection of and attending to sexual violence. The GPs registered these items during 1990 and 1991 after the first contact with any patient about a case of sexual violence (as defined by Draijer) previously unknown to them. The number of registered cases was 64 (corresponding to 17 per 10,000 patients), half of which concerned adults with sexual violence problems in their childhood. Offenders, nature and extent of the violence did not differ from descriptions in the literature. No cases were reported of still continuing violence. The 11 GPs differed significantly in the number of registered cases. The extent to which GP or patient took the initiative to bringing up the subject was not related to the number of cases registered by the GP. Patients referred and those not referred did not differ significantly in nature or extent of the sexual violence. Few follow-up appointments were made with non-referred patients. On the basis of these results, two items were formulated for better detection of and attending to sexual violence problems: stimulating the GP to an open, inviting attitude as well as active continuation of questioning in the case of complaints with a signal value; and making a follow-up appointment for non-referred patients.

Once-daily dosing regimen for aminoglycoside plus beta-lactam combination therapy of serious bacterial infections: comparative trial with netilmicin plus ceftriaxone.

PURPOSE: Once-daily dosing of aminoglycosides has been suggested to improve their efficacy and reduce their toxicity. To test the clinical validity of this suggestion, we conducted a prospective, randomized trial comparing a conventional multiple-daily-dosing regimen of netilmicin with once-daily administration of the same total daily dose of this aminoglycoside. PATIENTS AND METHODS: We enrolled 141 predominantly elderly patients with severe bacterial infections. All patients received once-daily doses of 2 g ceftriaxone, in addition to netilmicin. RESULTS: Patients randomized to either of the two dosing strategies were comparable regarding age, APACHE II score, concomitant diseases, infection site, and rate of culture-proven bacteremia. Netilmicin treatment did not differ significantly in mean daily dose per kg body weight and days of therapy between the two treatment arms. Compared to patients receiving conventional doses, patients treated with a once-daily dose had higher serum peak netilmicin levels and lower trough levels. Outcome of infection and mortality were not influenced by dosing strategy. Although the overall incidence of nephrotoxicity was similar in both groups (16%), the occurrence of nephrotoxicity in patients treated with once-daily doses of netilmicin was significantly shifted to those given prolonged treatment, i.e., beyond 9 days. Auditory toxicity was documented in one patient treated with conventional doses and two patients treated with once-daily doses. CONCLUSION: Once-daily dosing of an aminoglycoside plus a long-acting cephalosporin in these patients constituted cost-effective and safe treatment for severe bacterial infections. Netilmicin-induced toxicity may be reduced by using once-daily dosing regimens and limiting the duration of treatment.