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The Test of Adherence to Inhalers (TAI) Toolkit links an adherence measurement instrument (the TAI) to proven effective interventions for different causes of non-adherence to inhaled medication. This study aimed to assess the usability and feasibility of the TAI Toolkit in clinical practice. The TAI Toolkit was piloted in eight primary and secondary care settings. Each study site included 10 patients with asthma and/or COPD and suspected non-adherence. Healthcare professionals (HCPs) recorded clinical data and TAI Toolkit outcomes. Data on usability and feasibility were collected in semi-structured interviews and with the System Usability Score (SUS). Of the included patients, 81% were non-adherent, and sporadic non-adherence was the most common (69%). The TAI Toolkit was valued with a mean SUS-score of 85.9 by the HCPs. They found the toolkit to 'be visually attractive', 'easy-to-use' and 'give insight into patients' adherence', thereby offering good potential for its use in clinical practice.

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BACKGROUND: Poor adherence to inhaled medication has been associated with poor outcomes. Smart spacers can monitor inhaler use and technique, yet their feasibility in adults with asthma and their potential benefits are unknown. OBJECTIVE: Assessing the feasibility of undertaking a definitive randomized controlled trial (RCT) of smart spacer-based inhaler education and explore potential clinical benefits in adults with asthma. METHODS: Two-month randomized controlled feasibility OUtcomes following Tailored Education and Retraining: Studying Performance and AdherenCE (OUTERSPACE) trial comparing personalized smart spacer-based inhaler education versus usual care. Patients were recruited in four Dutch primary care centres. Outcomes were feasibility (inclusion speed, patient acceptance), medication adherence, inhaler technique, clinical effects (lung function, ACQ, FeNO) and usability (System Usability Scale [SUS]). RESULTS: 42 patients were randomized and all completed the study. The feasibility of performing a larger trial focusing on asthma patient education using a smart spacer was demonstrated with all patients included in four months and a participation rate of 86%. In the intervention group, inhalation errors per day decreased by 26.2% while in the usual care group inhalation errors increased by 14.6% (p = 0.021). Adherence decreased slightly in the intervention group as opposed to improvement in the control group (difference 12%, p = 0.028). No changes in lung function, ACQ or FeNO were observed. Usability was deemed high (SUS patients 71, nurses 89). CONCLUSION: This RCT showed that smart spacer-driven education in patients with asthma is feasible and in this short-term study reduced inhaler errors. Longer-term and larger studies are required to assess clinical effects.

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A 64-year-old patient came to the Emergency department because of dyspnea which occurred during diving in a lake. After analysis, it was concluded that it was caused by immersion pulmonary edema. This is believed to occur due to the water pressure, which leads to higher central blood volumes and thereby higher cardiac and pulmonary blood pressures, which lead to extravasation of fluid. After diuretics and oxygen supply, the patient was fully recovered.

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Pressurized metered dose inhalers are recommended to be used in combination with spacers, yet inhaler technique and adherence are poor. A novel digital "smart" spacer can record spacer use and technique errors and could facilitate personalized education. In this proof-of-concept study, we assessed the usability of the digital spacer and explored its effects on inhaler technique, adherence, long-term systemic drug exposure and clinical outcomes in COPD. Usability was deemed high. One month after personalized digital spacer inhaler education, the mean number of errors per patient per day decreased with 36%, from 6.40 errors/day to 4.07 errors/day (p = 0.038). Drug exposure was confirmed by bioanalytical scalp hair analysis of formoterol. No significant change in clinical outcomes was observed. This study demonstrates the digital spacer's potential value in inhaler education, but larger, longer-term studies are required.

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INTRODUCTION: Medication adherence and inhaler technique in patients with asthma remain suboptimal. A digital, smart spacer may support personalised adherence and inhaler technique education. The aim of this study is to assess the feasibility of undertaking a definitive randomised controlled trial of personalised, smart spacer data-driven education and explore clinical benefits. METHODS AND ANALYSIS: We present the design of the multicentre, randomised controlled OUtcomes following Tailored Education and Retraining: Studying Performance and AdherenCE feasibility trial of 2 months. Patients will be recruited from four Dutch general practices. At t=-1, patients with asthma ≥18 years using inhaled corticosteroids±long-acting beta-agonists±short-acting beta-agonists administered with a pressurised-metered-dose-inhaler and spacer (n=40) will use a smart spacer for 1 month. The rechargeable CE-marked smart spacer (Aerochamber Plus with Flow Vu) includes a sensor that monitors adherence and inhalation technique to prescribed dosing regimen of both maintenance and reliever inhalers. After 1 month (t=0), patients are 1:1 randomised into two groups: control group (usual care) versus intervention group (personalised education). At t=-1, t=0 and t=1 month, the Asthma Control Questionnaire (ACQ), Work Productivity and Activity Impairment (WPAI) questionnaire and Test of Adherence to Inhalers (TAI) are administered and fractional exhaled nitric oxide (FeNO) is assessed. At t=0 and t=1, spirometry is performed. At t=1, usability and satisfaction will be analysed using the System Usability Scale and interviews with patients and healthcare providers. Primary outcome is the overall feasibility of a definitive trial assessed by patient recruitment speed, participation and drop-out rate. Secondary outcomes are patient and healthcare provider satisfaction and exploratory clinical outcomes are adherence, inhaler technique, TAI score, FeNO, lung function, ACQ and WPAI. ETHICS AND DISSEMINATION: Ethical approval was obtained from the RTPO in Leeuwarden, Netherlands (number: NL78361.099.21). Patients will provide written informed consent. Study findings will be disseminated through conferences and peer-reviewed scientific and professional journals. TRIAL REGISTRATION NUMBER: NL9637.

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Sodium-glucose cotransporter-2-inhibitors are relatively new substances for treating patients with diabetes mellitus. Not least because of their rare, but severe side effects - especially euglycemic ketoacidosis - anaesthesiologists and physicians in intensive care should know about the pharmacologic properties and risk profile of sodium-glucose cotransporter-inhibitors. The present case report demonstrates typical laboratory findings of severe euglycemic ketoacidosis in a patient with only unspecific symptoms under therapy with gliflozins in the perioperative period. It describes the diagnostic and therapeutic steps and emphasizes the importance of withholding the substances under catabolic conditions. Especially in the perioperative setting it is highly relevant to consider euglycemic ketoacidosis as a differential diagnosis in the presence of a metabolic acidotic state, because a delayed diagnosis and treatment could be life-threatening for the affected person.

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AIM: To search for further immunodominant peptides of the pyruvate dehydrogenase complex E2-component (PDC-E2) recognized by antimitochondrial antibodies (AMA) in primary biliary cirrhosis (PBC). METHODS: Sera from 95 patients with PBC were tested by enzyme-linked immunosorbent assay against 33 synthetic overlapping peptides (25 amino acids; aa) covering the entire length of the E2-subunit of PDC-E2. Furthermore, the inner lipoyl peptide 167-184 was used in an unlipoylated and a lipoylated form as well as coupled to ovalbumin. Sera from 11 AMA negative/ANA positive PBC patients, 63 patients with other liver disorders and 22 healthy blood donors served as controls. RESULTS: Of the 95 PBC-sera, 74% reacted with the peptide 475-499 and 58% with the peptide 407-431 located within the catalytic domain of PDC-E2. Patients with other disorders or healthy controls were positive in only up to 18%. Antibodies to the unlipoylated and lipoylated peptide 167-184 within the inner lipoyl domain were found in only 5% and 11% of the PBC sera, respectively; using ovalbumin-coupled peptides, the incidence increased up to 57% (unlipoylated form). CONCLUSION: Peptides within the catalytic site of PDC-E2 rather than the previously reported lipoyl binding peptide 167-184 may represent major immunodominant epitopes recognized by AMA in PBC.

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BACKGROUND: Cardiac resynchronization therapy (CRT) is an established therapy for patients with severe heart failure and mechanical dyssynchrony. Response is only achieved in 60-70% of patients. OBJECTIVES: To study exercise-related factors predicting response to CRT. METHODS: We retrospectively examined consecutive patients in whom a CRT device was implanted. All underwent cardiopulmonary exercise testing prior to implantation and after 6 months. The occurrence of chronotropic incompetence and heart rates exceeding the upper rate of the device, thereby compromising biventricular stimulation, was studied. Response was defined as a decrease in LVESV of 10% or more after 6 months. RESULTS: We included 144 patients. After 6 months 86 (60%) patients were responders. Peak VO2 significantly increased in responders. Chronotropic incompetence was more frequently seen in nonresponders (21 [36%] vs 9 [10%], P = 0.03), mostly in patients in SR. At moderate exercise, defined as 25% of the maximal exercise tolerance, that is, comparable to daily life exercise, nonresponders more frequently went above the upper rate of the device (13 [22%] vs 2 [3%], P < 0.0001), most of whom were patients in permanent AF. Multivariate analysis revealed heart rates not exceeding the upper rate of the device during moderate exercise (OR 15.8 [3.3-76.5], P = 0.001) and nonischemic cardiomyopathy (OR 2.4 [1.0-5.7], P = 0.04) as predictive for response. CONCLUSIONS: Heart rate exceeding the upper rate during moderate exercise is an independent predictor for nonresponse to CRT in patients with AF, whereas chronotropic incompetence is a predictor for patients in SR.

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AIMS: To investigate the influence of interlead distance and lead positioning on success of cardiac resynchronization therapy (CRT) in patients with advanced chronic heart failure and electrical dyssynchrony. Despite application of established selection criteria, 20-40% of the patients do not respond to CRT. METHODS AND RESULTS: We examined consecutive patients in whom CRT was implanted. Response to CRT was defined as a decrease in the left ventricular end-systolic volume >or=10% after 6 months. A comparison was made between patients who were responders to CRT and those who were non-responders. A univariate and stepwise multivariate logistic regression was performed with regard to predictors for response. Between January 2004 and January 2008, 174 patients who were treated with CRT were classified as responders [n = 95 (55%)] or non-responders [n = 79 (45%)]. Responders had a significantly larger horizontal interlead distance on the lateral thoracic X-ray [odds ratio (OR) 2.8 (1.2-6.6), P = 0.01], a septal-to-lateral delay >60 ms [OR 4.9 (2.0-11.4), P < 0.0001], non-ischaemic cardiomyopathy [OR 3.0 (1.3-6.9), P = 0.009], a left ventricular end-diastolic diameter <67 mm [OR 4.2 (1.8-9.9), P = 0.001], angiotensin-converting enzyme inhibitor use [OR 8.1 (1.7-38.2), P = 0.008], and no tricuspid valve insufficiency [OR 6.9 (1.3-35.5), P = 0.02]. Post-implantation responders had a significantly greater decrease in the intraventricular delay (septal-to-lateral delay 62 +/- 62 vs. 26 +/- 65 ms, P = 0.001), but not in the interventricular mechanical delay. CONCLUSION: Larger interlead distance on the lateral thoracic X-ray, associated with positioning of the left ventricular lead in the posterior position, is associated with response after 6 months of follow-up. Furthermore, diminishing the septal-to-lateral delay is predictive for response.

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The effect of subcutaneous injection of physiological saline (given as 'placebo' in a randomized double-blinded placebo-controlled study) on immunocompetent cells from healthy individuals was analyzed. In two studies in 1998/1999 and 2002, 16 and 13 healthy individuals, respectively, were injected subcutaneously with 1 ml physiological saline twice a week for up to 12 weeks. Lymphocytes were isolated before and during exposure and incubated with recall antigens (purified protein derivative [PPD], tetanus toxoid [TT], bacillus Calmette-Guerin [BCG]). The production of T-helper type 1-, type 2-, and macrophage/monocyte-related cytokines was analyzed by ELISA. There was a significant increase of the recall-antigen-induced production of IFNgamma, IL-5, IL-13, TNFalpha, and GM-CSF in both groups during the observation period. Subcutaneous injection of placebo, therefore, enhances immunoreactivity. Psychological aspects, activation of the autonomous nerve system or local activation of mast cells or dendritic cells may be responsible for this phenomenon.

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AIMS: Cardiac resynchronization therapy (CRT) is an established therapy for patients with heart failure and sinus rhythm (SR), but its value in atrial fibrillation (AF) remains unclear. Furthermore, response to CRT may be difficult to predict in these patients. The aim of our study was to investigate whether predictors for CRT success differ between patients with AF and SR and to study the influence of present or developing AF on response to CRT. METHODS AND RESULTS: We examined consecutive patients in whom CRT was implanted disregarding the atrial rhythm. Atrial fibrillation was defined as either current or earlier AF, response to CRT was defined as a decrease in the left ventricular end-systolic volume of > or = 10% after 6 months. Total atrial conduction time (TACT), a measure to predict the risk of developing AF, was determined by echocardiography. We included 114 patients, of whom 56 (49%) were known with AF (23 current AF and 33 earlier AF). The other 58 patients had no history of AF. After 6 months, response in current and earlier AF and that in SR patients was comparable (56, 58 and 55%, respectively). In AF patients, multivariate analysis revealed a shorter TACT at baseline [odds ratio (OR) 16.7 (1.5-185.3), P = 0.02] and an interventricular mechanical delay (IVMD) > 40 ms [OR 10.4 (1.0-110.9), P = 0.05] as predictors for response. Non-responders more frequently suffered from new-onset AF (P = 0.02). CONCLUSION: Failure to CRT is associated with new-onset AF. Total atrial activation time may be a parameter to predict response in AF patients.

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