Drug-drug interactions in nursing home residents: analysis from the COME-ON trial.

BACKGROUND: as a result of the high prevalence of polypharmacy in nursing homes (NHs), nursing home residents (NHRs) are exposed to numerous drug-drug interactions (DDIs) that can lead to adverse drug effects, and increased morbidity and mortality. OBJECTIVES: to evaluate (i) the prevalence of DDIs among NHRs and its evolution over time, and (ii) factors associated with a favourable evolution. DESIGN: posthoc analysis of the COME-ON study, a cluster-randomised controlled trial aiming at reducing potentially inappropriate prescriptions in NHs, through the implementation of a complex intervention. SETTING AND SUBJECTS: 901 NHRs from 54 Belgian NHs. METHODS: DDIs were identified using a validated list of 66 potentially clinically relevant DDIs in older adults. We defined a favourable evolution at 15 months as the resolution of at least one DDI present at baseline, without the introduction of any new DDI. Factors associated with a favourable evolution were analysed using multivariable logistic regression. RESULTS: at baseline, 475 NHRs (52.7%) were exposed to at least 1 DDI and 225 NHRs (25.0%) to more than one DDI. Most common DDI was 'Concomitant use of at least three central nervous system active drugs'. At 15 months, we observed a 6.3% absolute decrease in DDI prevalence in intervention group, and a 1.0% absolute increase in control group. The intervention, older age and private NH ownership were significantly associated with a favourable DDI evolution. CONCLUSION: a high prevalence of DDI in Belgian NHs was observed, but the COME-ON intervention was associated with a favourable evolution over time.

How do people living with chronic conditions and their informal caregivers experience primary care? A phenomenological-hermeneutical study.

AIMS AND OBJECTIVES: Gaining insight in how people living with chronic conditions experience primary healthcare within their informal network. BACKGROUND: The primary healthcare system is challenged by the increasing number of people living with chronic conditions. To strengthen chronic care management, literature and policy plans point to a person-centred approach of care (PCC). A first step to identify an appropriate strategy to implement PCC is to gain more insight into the care experiences of these people and their informal caregivers. DESIGN: A phenomenological-hermeneutical philosophy is used. The study is in line with the Consolidated Criteria for Reporting Qualitative Research Guidelines (COREQ). METHOD: In-depth, semi-structured interviews with people living with chronic conditions and informal caregiver dyads (PCDs) (n = 16; 32 individuals) were conducted. An open-ended interview guide was used to elaborate on the PCDs' experiences regarding primary care. A purposive, maximal variation sampling was applied to recruit the participants. RESULTS: Based on sixteen PCDs' reflections, ten themes were identified presenting their experiences with primary care and described quality care as listening and giving attention to what people with chronic conditions want, to what they strive for, and above all to promote their autonomy in a context wherein they are supported by a team of formal caregivers, family and friends. CONCLUSION: To meet the PCDs' needs, self-management should be addressed in an interprofessional environment in which the PCD is an important partner. The findings may facilitate a shift to encourage PCDs in their strengths by enabling them to share their personal goals and by working towards meaningful activities in team collaboration. RELEVANCE TO CLINICAL PRACTICE: Three strategies-self-management support, goal-oriented care, and interprofessional collaboration-have been suggested to improve the PCDs' primary care experiences. These strategies could guide nursing practice in using more and improve high-quality nursing care.

Change in carbohydrate intake one year after Roux-en-Y gastric bypass: A prospective study.

Background and objectives: To investigate the effect of carbohydrate intake before laparoscopic Roux-en-Y gastric bypass (LRYGB) on body weight, body composition and glycaemic status after surgery. Methods: In a tertiary centre cohort study, dietary habits, body composition and glycaemic status were evaluated before and 3, 6 and 12 months after LRYGB. Detailed dietary food records were processed by specialized dietitians on the basis of a standard protocol. The study population was subdivided according to relative carbohydrate intake before surgery. Results: Before surgery, 30 patients had a moderate relative carbohydrate intake (26%-45%, M-CHO), a mean body mass index (BMI) of 40.4 ± 3.9 kg/m² and a mean glycated haemoglobin A1c (A1C) of 6.5 ± 1.2% compared to 20 patients with a high relative carbohydrate intake (> 45%, H-CHO), mean BMI of 40.9 ± 3.7 kg/m² (non-significant, NS) and a mean A1C of 6.2% (NS). One year after surgery, body weight, body composition and glycaemic status were similar in the M-CHO (n = 25) and H-CHO groups (n = 16), despite less caloric intake in the H-CHO group (1317 ± 285 g vs. 1646 ± 345 g in M-CHO, p < 0.01). Their relative carbohydrate intake converged to 46% in both groups, but the H-CHO group reduced the absolute total carbohydrate consumption more than the M-CHO group (190 ± 50 g in M-CHO vs. 153 ± 39 g in H-CHO, p < 0.05), and this was especially pronounced for the mono- and disaccharides (86 ± 30 g in M-CHO vs. 65 ± 27 g in H-CHO, p < 0.05). Conclusion: A high relative carbohydrate intake before LRYGB, did not influence the change in body composition or diabetes status after surgery, despite a significantly lower total energy intake and less mono- and disaccharide consumption after surgery.

Perspectives on seamless collaboration between primary and secondary care for oral anticancer treatments.

Patients who take oral anticancer drugs (OACD) alternate between the hospital and the community setting. Little is known about how general practitioners (GPs) and community pharmacists (CPs) from primary care (PC) can be involved in providing seamless care. In an exploratory qualitative study, semi-structured interviews with healthcare professionals from primary and secondary care (SC) and (N = 26) were performed to investigate perceptions of seamless collaboration for patients on OACD. Seamless collaboration initiated by SC was restricted to informing GPs about treatment-initiation and delegating limited tasks to them in treatment monitoring. CPs are currently not informed by SC about the treatment. PC expressed willingness for seamless collaboration. However, collaboration is currently impeded due to an expressed lack of trust and desire for control by SC. Moreover, SC expressed unfamiliarity with the organization of PC. Findings suggest that healthcare professionals from SC and PC need to get to know each other and to discuss expectations in the seamless care for patients on OACD. A possible strategy is to elaborate a shared care model based on a partnership between PC and SC, in which the specific expertise of each partner contributes to patient-centered care and the qualitative and safe use of OACD.

Resident and informal caregiver involvement in medication-related decision-making and the medicines' pathway in nursing homes: experiences and perceived opportunities of healthcare professionals.

BACKGROUND: Person-centered care has been shown to be beneficial for nursing home residents. The know-how and attitude of healthcare professionals, however, can make its implementation difficult. Also, research on person-centered care with regard to medication decision-making and the medicines' pathway in nursing homes is lacking. This study aimed to provide an understanding of healthcare professionals' attitudes and perspectives on current resident and informal caregiver involvement in medication decision-making and the medicines' pathway in nursing homes. METHODS: A qualitative, explorative study using semi-structured interviews with a sample of 25 healthcare professionals from four different nursing homes was performed. Interview transcripts were analyzed by means of an inductive thematic framework. RESULTS: Three overarching domains were identified: 1) features of, 2) drivers and barriers for, and 3) perceived consequences of resident and informal caregiver involvement in medication decision-making and the medicines' pathway. Involvement was mainly initiated by residents and informal caregivers themselves, pointing towards information and participation needs among both groups. Nevertheless, actions of healthcare professionals towards resident and informal caregiver involvement were mainly reactive and fragmentary. Their actions were influenced by the perception of residents and informal caregivers' desire and capabilities to be involved, the perception of their own professional role, but also by organizational factors such as the nursing home's philosophy. Furthermore, organizational concerns tempered the motivation to provide residents and informal caregivers with more medication-related responsibilities. CONCLUSIONS: Resident and informal caregiver involvement in medication decision-making and the medicines' pathway remains limited in nursing homes. Information and participation needs of residents and informal caregivers were not fully acknowledged by healthcare professionals. As such, we can conclude that there is a need for initiatives, both on an individual and on an organizational level, to create and improve awareness on opportunities to improve resident and informal caregiver involvement in medication decision-making and the medicines' pathway.

CONTACT-Patient-Centred Care Questionnaire to assess care for patients treated with oral anticancer drugs: Development and psychometric validation.

OBJECTIVE: Instruments to measure quality of patient-centred care (PCC) for the rapidly growing population of patients treated with oral anticancer drugs (OACD) are lacking. The aim of this study was to develop a valid and reliable instrument to assess PCC in the context of OACD. METHODS: The CONTACT-Patient-Centred Care Questionnaire (CONTACT-PCCQ) was developed based on a validated set of key elements (KEs) for patient-centred education and counselling in patients taking OACD, and face validity was evaluated by means of cognitive interviews. In 16 Belgian hospitals, adult patients treated with OACD were asked to complete the questionnaire. Construct validity was investigated through exploratory factor analyses (EFAs) and internal consistency of the subscales was examined using Cronbach's alpha. RESULTS: The initial 86-item instrument was completed by 464 patients. Each EFA confirmed the a priori PCC-based structure of the subscales. However, EFA revealed more than one factor for two of the subscales. Therefore, multiple subsections within these subscales were created. Based on factor loadings and item content, six items were removed. This resulted in a final 80-item instrument with seven subscales and five subsections. Cronbach's alpha for the subscales and subsections ranged between 0.732 and 0.918, which implies adequate internal consistency. CONCLUSION: A final instrument with 80 items divided into seven subscales, covering all six dimensions of PCC, was obtained. The CONTACT-PCCQ has acceptable psychometric properties, supporting its use as a measure to assess care experiences of patients treated with OACD.

Overall performance of a drug-drug interaction clinical decision support system: quantitative evaluation and end-user survey.

BACKGROUND: Clinical decision support systems are implemented in many hospitals to prevent medication errors and associated harm. They are however associated with a high burden of false positive alerts and alert fatigue. The aim of this study was to evaluate a drug-drug interaction (DDI) clinical decision support system in terms of its performance, uptake and user satisfaction and to identify barriers and opportunities for improvement. METHODS: A quantitative evaluation and end-user survey were performed in a large teaching hospital. First, very severe DDI alerts generated between 2019 and 2021 were evaluated retrospectively. Data collection comprised alert burden, override rates, the number of alert overrides reviewed by pharmacists and the resulting pharmacist recommendations as well as their acceptance rate. Second, an e-survey was carried out among prescribers to assess satisfaction, usefulness and relevance of DDI alerts as well as reasons for overriding. RESULTS: A total of 38,409 very severe DDI alerts were generated, of which 88.2% were overridden by the prescriber. In 3.2% of reviewed overrides, a recommendation by the pharmacist was provided, of which 79.2% was accepted. False positive alerts were caused by a too broad screening interval and lack of incorporation of patient-specific characteristics, such as QTc values. Co-prescribing of a non-vitamin K oral anticoagulant and a low molecular weight heparin accounted for 49.8% of alerts, of which 92.2% were overridden. In 88 (1.1%) of these overridden alerts, concurrent therapy was still present. Despite the high override rate, the e-survey revealed that the DDI clinical decision support system was found useful by prescribers. CONCLUSIONS: Identified barriers were the lack of DDI-specific screening intervals and inclusion of patient-specific characteristics, both leading to a high number of false positive alerts and risk for alert fatigue. Despite these barriers, the added value of the DDI clinical decision support system was recognized by prescribers. Hence, integration of DDI-specific screening intervals and patient-specific characteristics is warranted to improve the performance of the DDI software.

Experiences of patients with cancer and their relatives confronted with COVID-19 related delay or change in care: A qualitative study.

AIMS: To provide in-depth insight into how patients and their relatives experienced change or delay in cancer treatment and care due to COVID-19. DESIGN: A qualitative study including semi-structured interviews with patients with cancer and their relatives. METHODS: Between July and October 2020, 42 patients who were confronted with a change or delay in cancer treatment or care, and 11 relatives were interviewed. Data collection and analysis were performed according to the most important methods of grounded theory, including iterative data collection and analysis, theoretical sampling, constant comparative analysis and theoretical sensitivity. RESULTS: This study shows that patients with cancer and relatives experienced paradoxical feelings when confronted with change or delay in treatment or care due to COVID-19. Patients and relatives felt relieved (e.g. less risk of infection), but were also concerned and anxious (e.g. fear for progression, fear for more side effects). Due to these ambivalent feelings, it was difficult for patients and relatives to cope with the change or delay in treatment or care, both when this was decided by the physician and by themselves. In combination with the general impact of COVID-19 on their daily lives, the change or delay led to additional distress. The interviews showed that exploring the meaning of change or delay of care for patients and their relatives and discussing what would help them might prevent or relieve distress. CONCLUSION: The findings of our study show that COVID-19 and the associated delay or changes in cancer treatment and care had a major impact on the well-being of patients and their relatives. Person-oriented care is even more important during (emergency) situations in which care might be changed or delayed.

Evaluation of interprofessional care processes for patients treated with oral anticancer drugs.

Information on interprofessional team composition and functioning in the care for patients on oral anticancer drugs (OACDs), and how healthcare professionals (HCPs) evaluate in-hospital care processes is scarce. We aimed to investigate interprofessional care processes for OACD-patients in a partially mixed-methods study. A combination of (a) the CareProces Self-Evaluation Tool (CPSET), completed by HCP-team members by health profession who were either currently involved in care processes (oncologists and nurses) or potentially involved in future care (pharmacists, psychologists, social workers), and by hospital managers (N = 87) and (b) semi-structured interviews in a subsample of oncologists, nursing staff, and pharmacists (N = 26) were used. Care process coordination was evaluated poorly, mainly by nurses, pharmacists, and psychologists. Nurses and pharmacists believed that they were not engaged in the organization of OACD care, lacked role clarity, and perceived no meaningful interprofessional practice. HCPs had different perceptions toward timing and planning of patient education and follow-up. Monitoring of care processes occurred only occasionally and was unstructured resulting in apoor complication-management and variance within care processes. Care processes for OACD-patients showed opportunities for optimization of interprofessional practice in timing, planning, and monitoring. Rethinking care processes through co-design is needed.

Mental health status of pregnant and breastfeeding women during the COVID-19 pandemic-A multinational cross-sectional study.

INTRODUCTION: Evidence on perinatal mental health during the coronavirus disease 2019 (COVID-19) pandemic and its potential determinants is limited. Therefore, this multinational study aimed to assess the mental health status of pregnant and breastfeeding women during the pandemic, and to explore potential associations between depressive symptoms, anxiety, and stress and women's sociodemographic, health, and reproductive characteristics. MATERIAL AND METHODS: A cross-sectional, web-based study was performed in Ireland, Norway, Switzerland, the Netherlands, and the UK between 16 June and 14 July 2020. Pregnant and breastfeeding women up to 3 months postpartum who were older than 18 years of age were eligible. The online, anonymous survey was promoted through social media and hospital websites. The Edinburgh Depression Scale (EDS), the Generalized Anxiety Disorder seven-item scale (GAD-7), and the Perceived Stress Scale (PSS) were used to assess mental health status. Regression model analysis was used to identify factors associated with poor mental health status. RESULTS: In total, 9041 women participated (including 3907 pregnant and 5134 breastfeeding women). The prevalence of major depressive symptoms (EDS ≥ 13) was 15% in the pregnancy cohort and and 13% the breastfeeding cohort. Moderate to severe generalized anxiety symptoms (GAD ≥ 10) were found among 11% and 10% of the pregnant and breastfeeding women. The mean (±SD) PSS scores for pregnant and breastfeeding women were 14.1 ± 6.6 and 13.7 ± 6.6, respectively. Risk factors associated with poor mental health included having a chronic mental illness, a chronic somatic illness in the postpartum period, smoking, having an unplanned pregnancy, professional status, and living in the UK or Ireland. CONCLUSIONS: This multinational study found high levels of depressive symptoms and generalized anxiety among pregnant and breastfeeding women during the COVID-19 outbreak. The study findings underline the importance of monitoring perinatal mental health during pandemics and other societal crises to safeguard maternal and infant mental health.

A prolonged QTc-interval at the emergency department: Should we always be prepared for the worst?

INTRODUCTION: QTc-interval prolongation is associated with ventricular arrhythmias and mortality in a general population. Bazett's correction formula (QTcB) is routinely used despite its overcorrection at high heart rates. Recently, we proposed a patient-specific QT correcting algorithm (QTcA) resulting in improved rate correction and predictive value in a general population. We hypothesize risk stratification at the Emergency Department (ED) could be improved using QTcA. METHODS AND RESULTS: A retrospective case-control study including a randomized age- and sex-matched control population was performed at a tertiary care ED. A total of 1930 patients were included in the analysis (63.0% males, age 71.5 ± 15.6 years). Patient characteristics, history, and test results at the time of the electrocardiogram were collected. QTc was dichotomized as prolonged (>450 millisecond for men, >470 millisecond for women) or severely prolonged (>500 millisecond). Implementation of QTcA would reduce the number of patients considered to have a prolonged QTc by 65.2%, for severely prolonged QTc 79.6%. Multivariate regression was performed for in-hospital mortality, cardiovascular endpoints, and hospital admission. Neither a prolonged QTcB (HR 1.04; 95% CI, 0.64-1.69) nor QTcA (HR 0.76; 95% CI, 0.42-1.38) was an independent predictor of in-hospital mortality. A severely prolonged QTcA (OR, 2.54; 95% CI, 1.04-6.23) was an independent predictor of cardiovascular events. Both a prolonged QTcA (OR, 1.52; 95% CI, 1.06-2.18) and a prolonged QTcB (OR, 1.37; 95% CI, 1.05-1.79) were associated with higher hospitalization rates. CONCLUSIONS: QTcA reduced the number of patients considered at risk. Neither QTcB nor QTcA were predictors of in-hospital mortality. A severely prolonged QTcA was associated with cardiovascular events.

Beliefs about medicines and information needs among pregnant women visiting a tertiary hospital in Belgium.

PURPOSE: To explore beliefs about medicines and information needs among pregnant women visiting a tertiary hospital in Belgium and to identify patient characteristics associated with beliefs about medicines. METHODS: A cross-sectional study was performed at the outpatient obstetrics clinic of the University Hospital Leuven, Belgium, between December 2016 and March 2017. All pregnant women ≥ 18 years were invited to complete a web survey. The survey consisted of general and pregnancy-specific statements of the "Beliefs about Medicines" questionnaire and questions about information needs. Descriptive statistics, chi-square tests, Fisher's exact tests, and multinomial logistic regression were used to analyze the findings. RESULTS: In total, 372 pregnant women participated. Most women showed positive attitudes towards medicines in general. However, almost 90% of women agreed to have a higher threshold to use medicines during pregnancy compared with non-pregnant situations. Likewise, 40% preferred natural remedies during pregnancy. Education in healthcare and education level were the main determinants associated with beliefs, with highly educated women showing a higher threshold to use medicines during pregnancy (p = 0.005). Most women searched online for pregnancy-related information (85%) and for information about medicines (74%). However, less than one-third discussed online-retrieved information with healthcare professionals (HCPs). CONCLUSIONS: Pregnant women visiting a tertiary hospital in Belgium showed a higher threshold to use medicines during pregnancy compared with non-pregnant situations and had high information needs, including for information about medicines during pregnancy. HCPs should be aware of women's individual beliefs, guide them towards reliable websites, and discuss online-retrieved information during counseling.

Health products' and substance use among pregnant women visiting a tertiary hospital in Belgium: A cross-sectional study.

PURPOSE: To investigate the prevalence and type of health products used among pregnant women visiting a tertiary hospital in Belgium, as well as who advises these products, where women buy these products, which determinants are associated with medication and pregnancy vitamin intake, and preconception lifestyle changes such as folic acid intake and substance use. METHODS: A cross-sectional study was performed at the outpatient obstetrics clinics of the University Hospital Leuven, Belgium between November 2016 and March 2017. All pregnant women 18 years and older and understanding Dutch, French, or English were asked to participate in an online survey. RESULTS: In total, 379 pregnant women participated. Prevalence of medication use during the preceding week was 52%. Paracetamol (14%), levothyroxine (13%), and antacids (9%) were the most frequently used medicines. Pregnancy vitamins were used by 86% of women, and 97% had used a pregnancy vitamin somewhere during pregnancy. Only 56% initiated folic acid supplementation at least 1 month before pregnancy. Preconception use of folic acid among women following assisted reproductive technology was 73%. Inappropriate use of health products was observed among 3% of women. Prevalence of alcohol use and/or smoking during the preceding week was 6%. Alcohol and smoking cessation mainly occurred after pregnancy diagnosis. CONCLUSION: Pregnant women living in Belgium frequently use medicines, pregnancy vitamins, and other health products. Preconception lifestyle changes such as folic acid intake and alcohol and smoking cessation are poorly implemented. Public campaigns and interventions are needed to improve preconception care and counselling.

Collaborative network to take responsibility for oral anticancer therapy (CONTACT): Study-protocol investigating the impact of a care pathway.

AIM: To evaluate the effectiveness, feasibility, meaningfulness and appropriateness of the development and implementation of a transmural care pathway in four hospitals in Flanders to improve self-management support in healthcare professionals and self-management in patients treated with oral anticancer drugs. DESIGN: A multicentre, prospective, interventional before-after study. METHOD: The development and implementation of the care pathway is based on the 7-phase method by Vanhaecht et al. (2012). Before and after, the care process will be evaluated from the perspective of patients, healthcare professionals in the hospital and from primary care and the available evidence. In both study-parts, a mixed methods approach will be used including observations, semi-structured interviews, focus groups and validated questionnaires for outcome assessments. The primary outcome is self-management in patients and self-efficacy and perception towards self-management in healthcare professionals. This study was funded in October 2015 and has been approved by the Ethics Committee in June 2016. DISCUSSION: Due to the growing number of patients taking oral anticancer drugs, there is need for a rigorous study that aims to optimize self-management in patients and self-management support provided by an interdisciplinary team of healthcare professionals (including oncology nurses and clinical nurse specialists). The care pathway should therefore consist of effective self-management supporting interventions and should clearly define the role of all stakeholders. IMPACT: This study attempts to obtain standardization, uniformity and continuity of self-management support provided by healthcare professionals to patients on oral anticancer drugs with the aim to achieve an adequate level of self-management. TRIAL REGISTRATION: clinicaltrials.gov NCT02861209.

A smart algorithm for the prevention and risk management of QTc prolongation based on the optimized RISQ-PATH model.

AIMS: QTc prolongation is a complex problem linked with multiple risk factors. The RISQ-PATH score was previously developed to identify high-risk patients for QTc prolongation. The aim of this study was to optimize and validate this risk score in a large patient cohort, and to propose an algorithm to generate smart QT signals in the electronic medical record. METHODS: A retrospective study was performed in the Nexus hospital network (n = 17) in Belgium. All electrocardiograms performed in 2015 in both ambulatory and hospitalized patients were collected together with risk factors for QTc prolongation (training database). Multiple logistic regression was performed to obtain the optimal prediction (RISQ-PATH) model. The model was tested in a validation database (electrocardiograms between January and April 2016). RESULTS: In total, 60 208 patients (52.8% males, mean age 63 ± 18 years) were included; 3543 patients (5.9%) had a QTc ≥ 450(♂)/470(♀) ms and 453 (0.8%) a QTc ≥ 500 ms. The optimized RISQ-PATH model has an area under the ROC-curve of 0.772 [95% CI 0.763-0.780] to predict QTc ≥ 450(♂)/470(♀)ms. A predicted probability of ≥0.035 was set as cutoff for a high risk of QTc prolongation. This cutoff resulted in a sensitivity of 87.4% [95% CI 86.2-88.5] and a specificity of 46.2% [95% CI 45.8-46.6]. These results could be confirmed for QTc ≥ 500 ms and in the validation database (n = 28 400). CONCLUSIONS: The RISQ-PATH model, with a cutoff probability of 0.035, predicted a prolonged QTc interval ≥ 450/470 ms or ≥500 ms with a sensitivity of ±87% and a specificity of ±45%. This RISQ-PATH model can be used in clinical decision support systems to create smart QT alerts.

QT correction across the heart rate spectrum, in atrial fibrillation and ventricular conduction defects.

BACKGROUND: Incorporation of QTc in clinical decision support systems requires accurate QT-interval correction, also during common electrocardiogram abnormalities as ventricular conduction defects (VCD). We compared the performance and predictive value of QT correction formulas to design a patient-specific QT correction algorithm (QTcA). METHODS: The first ECG in adult patients with sinus rhythm (SR), atrial fibrillation (AF), and ventricular pacing (VP) was collected retrospectively. QT correction was performed with Bazett (QTcB), Fridericia (QTcFri), Framingham, Hodges, and Rautaharju (QTcR) formulas. Correction formulas were compared using QTc/RR linear regression. Adjusted Cox regression was performed to predict 1-year all-cause mortality. RESULTS: A total of 49,737 patients were included (70.0% SR, 24.1% AF, 5.9% VP, 11.1% VCD). Overall 1-year all-cause mortality rate was 11.8%. In patients without VCD or VP, QTcFri showed significantly better heart rate correction, both overall (P < 0.001) and in subgroups by heart rate (bradycardia P ≤ 0.001, normal P ≤ 0.050, tachycardia P ≤ 0.010). Furthermore, QTcFri improved mortality prediction significantly when compared to QTcB (P < 0.001). Patients with VCD or VP QTcR, including correction for QRS duration, had a significant better heart rate correction than QTcB (P ≤ 0.010) and improved mortality prediction significantly compared to all other formulas (P < 0.001). Implementing QTcA, designed based on QTcFri and QTcR depending on the presence of VCD or VP, reduced the patients considered to be at risk by 61.1% when compared to QTcB. CONCLUSIONS: A patient-specific QT correction algorithm would combine accurate heart rate correction, improved predictive value of mortality, and a reduction of patients considered to be at risk.

Risk Management of Hospitalized Psychiatric Patients Taking Multiple QTc-Prolonging Drugs.

PURPOSE/BACKGROUND: Drug-related QTc prolongation has been linked with Torsade de Pointes and sudden cardiac death. The objective of this study was to investigate the impact of starting an additional QTc-prolonging drug on the QTc interval of psychiatric inpatients. METHODS: An observational study was performed between May 2011 and December 2014 in 6 Belgian psychiatric hospitals. Inpatients who were already taking 1 QTc-prolonging drug or more could be included in the study when an additional QTc-prolonging drug was started. Electrocardiograms were performed at baseline and follow-up. Demographic, medical, medication, and laboratory data were collected. A risk score was used to estimate the risk of QTc prolongation based on patient-specific risk factors. A cutoff value of 8 points was set as high risk for QTc prolongation. RESULTS: One hundred fifty-two patients (44.7% women; mean age, 44 [SD, 17] years) were included who received a prescription for an additional QTc-prolonging drug. There was a small but significant difference (P = 0.032) in mean QTc interval between baseline (409.1 [SD, 21.8] milliseconds) and follow-up (411.8 [SD, 21.7] milliseconds). Three patients developed a prolonged QTc interval in the follow-up electrocardiogram (QTc, ≥450 [men]/470 [women] milliseconds); 8 patients had a delta QTc of 30 milliseconds or longer. No cases of torsade de pointes or sudden cardiac death were identified. Fifty-eight patients (38.2%) had a risk score of 8 or higher; these patients had a significantly longer QTc interval at follow-up than did patients with a risk score of lower than 8 (P < 0.001). IMPLICATIONS/CONCLUSIONS: Only a limited number of patients developed a prolonged QTc interval after the start of an additional QTc-prolonging drug. Nevertheless, it is still important to screen for high-risk patients at baseline. A risk score can help to select high-risk patients and to stimulate an appropriate and feasible risk management of QTc prolongation in psychiatry.

Developing a decision rule to optimise clinical pharmacist resources for medication reconciliation in the emergency department.

BACKGROUND: The process of obtaining a complete medication history for patients admitted to the hospital from the ED at hospital admission, without discrepancies, is error prone and time consuming. OBJECTIVES: The goal of this study was the development of a clinical decision rule (CDR) with a high positive predictive value in detecting ED patients admitted to hospital at risk of at least one discrepancy during regular medication history acquisition, along with favourable feasibility considering time and budget constraints. METHODS: Data were based on a previous prospective study conducted at the ED in Belgium, describing discrepancies in 3592 medication histories. Data were split into a training and a validation set. A model predicting the number of discrepancies was derived from the training set with negative binomial regression and was validated on the validation set. The performance of the model was assessed. Several CDRs were constructed and evaluated on positive predictive value and alert rate. RESULTS: The following variables were retained in the prediction model: (1) age, (2) gender, (3) medical discipline for which the patient was admitted, (4) degree of physician training, (5) season of admission, (6) type of care before admission, number of (7) drugs, (8) high-risk drugs, (9) drugs acting on alimentary tract and metabolism, (10) antithrombotics, antihaemorrhagics and antianaemic preparations, (11) cardiovascular drugs, (12) drugs acting on musculoskeletal system and (13) drugs acting on the nervous system; all recorded by the ED physician on admission. The final CDR resulted in an alert rate of 29% with a positive predictive value of 74%. CONCLUSION: The final CDR allows identification of the majority of patients with a potential discrepancy within a feasible workload for the pharmacy staff. Our CDR is a first step towards a rule that could be incorporated into electronic medical records or a scoring system.

Drug disposition before and after gastric bypass: fenofibrate and posaconazole.

AIMS: Roux-en-Y gastric bypass (RYGB) alters the anatomical structure of the gastrointestinal tract, which can result in alterations in drug disposition. The aim of the present study was to evaluate the oral disposition of two compounds belonging to the Biopharmaceutical Classification System Class II - fenofibrate (bile salt-dependent solubility) and posaconazole (gastric pH-dependent dissolution) - before and after RYGB in the same individuals. METHODS: A single-dose pharmacokinetic study with two model compounds - namely, 67 mg fenofibrate (Lipanthyl®) and 400 mg posaconazole (Noxafil®) - was performed in 12 volunteers pre- and post-RYGB. After oral administration, blood samples were collected at different time points up to 48 h after administration. Plasma concentrations were determined by high-performance liquid chromatography in order to calculate the area under the concentration-time curve up to 48 h (AUC0-48 h ), the peak plasma concentration (Cmax) and the time to reach peak concentration (Tmax ). RESULTS: After administration of fenofibrate, no relevant differences in AUC0-48 h , Cmax and Tmax between the pre- and postoperative setting were observed. The geometric mean of the ratio of AUC0-48 h post/pre-RYGB for fenofibrate was 1.10 [95% confidence interval (CI) 0.87, 1.40; P = 0.40]. For posaconazole, an important decrease in AUC0-48 h and Cmax following RYGB was shown; the geometric mean of the AUC0-48 h post/pre-RYGB ratio was 0.68 (95% CI 0.48, 0.96; P = 0.03) and the geometric mean of the Cmax pre/post-RYGB ratio was 0.60 (95% CI 0.39, 0.94; P = 0.03). The decreased exposure of posaconazole could be explained by the increased gastric pH and accelerated gastric emptying of fluids post-RYGB. No difference for Tmax was observed. CONCLUSIONS: The disposition of fenofibrate was not altered after RYGB, whereas the oral disposition of posaconazole was significantly decreased following RYGB.