Fat-rich versus carbohydrate-rich nutrition in ALS: a randomised controlled study

ObjectiveThere is growing evidence that the course of amyotrophic lateral sclerosis (ALS) may be influenced beneficially by applying high-caloric food supplements (HCSs). However, it is unknown which composition of nutrients offers optimal tolerability and weight gain.MethodsWe conducted a randomised controlled study (Safety and Tolerability of Ultra-high-caloric Food Supplements in Amyotrophic Lateral Sclerosis (ALS); TOLCAL-ALS study) in 64 patients with possible, probable or definite ALS according to El Escorial criteria. Patients were randomised into four groups: a high-caloric fatty supplement (HCFS; 405 kcal/day, 100% fat), an ultra-high-caloric fatty supplement (UHCFS; 810 kcal/day, 100% fat), an ultra-high-caloric, carbohydrate-rich supplement (UHCCS; 900 kcal/day, 49% carbohydrates) and an open control (OC) group without any supplement. The primary endpoint was tolerability. Patients were followed up over 4 weeks.ResultsGastrointestinal side effects were most frequent in the UHCFS group (75.0%), while loss of appetite was most frequent in the UHCCS group (35.3%). During intervention, patients gained +0.9 kg/month of body weight (IQR −0.9 to 1.5; p=0.03) in the HCFS group and +0.9 kg/month (IQR −0.8 to 2.0; p=0.05) in the UHCFS group. A non-significant trend for weight gain (+0.6 kg/month (IQR −0.3 to 1.9; p=0.08)) was observed in the UHCCS group. Patients in OC group continued to lose body weight (−0.5 kg/month, IQR −1.4 to 1.3; p=0.42).InterpretationThe findings suggest that HCSs frequently cause mild to moderate tolerability issues in patients with ALS, most notably gastrointestinal symptoms in high-fat supplements, and loss of appetite in high-carbohydrate supplements. All three HCSs tested are suited to increase body weight.

Pharmacist-Facilitated Interactive E-Learning for Patients Newly Initiated on Warfarin: A Randomised Controlled Study

It is not known whether electronic-learning (e-learning) is effective for educating hospital inpatients about complex medications such as warfarin. This prospective randomised controlled study compared pharmacist-facilitated e-learning with standard pharmacist-delivered face-to-face education on patients’ or their unpaid carers’ knowledge of warfarin and satisfaction with warfarin education as well as the time that was spent by pharmacists in delivering warfarin education. Adult English-speaking patients (or their carers) who had been prescribed warfarin were randomised to receive standard pharmacist face-to-face education (control) or an e-learning module on a tablet device facilitated by a pharmacist (intervention). All of the participants received written warfarin information and were presented with the opportunity to ask any questions that they may have had to a pharmacist. Fifty-four participants completed the study (27 per group). The participants who received e-learning had median correct Oral Anticoagulation Knowledge (OAK) test scores of 85% compared to 80% for standard education (p = 0.14). The participants in both groups were satisfied with the information that they received. There was a trend towards pharmacists spending less time on warfarin education for the e-learning group than in the standard education group (25.5 vs. 33 min, respectively, p = 0.05). Education delivered via pharmacist-facilitated e-learning was non-inferior in terms of patient or carer warfarin knowledge compared to standard pharmacist-delivered education.

A Multicentre Randomised Controlled Study Evaluating the Effect of a Standardised Education Programme on Quality of Life, Disease Severity, and Disease Knowledge in Patients with Moderate-To-Severe Psoriasis: The EDUPSO Study

<b><i>Background:</i></b> Psoriasis is a chronic inflammatory skin disease that has a profound effect on health-related quality of life (HRQoL). Patient education programmes may help patients to gain life-long control over their chronic disease. <b><i>Objective:</i></b> This multicentre randomised controlled study evaluated whether a standardised multidisciplinary education programme was beneficial to psoriasis patients. <b><i>Methods:</i></b> Adults with moderate-to-severe psoriasis were randomly assigned (1:1) to an intervention group to receive an educational programme or to a control group to receive usual care. Randomization was stratified by previous treatment history. The primary outcome was HRQoL, assessed by scoring the Skindex-29 domains emotion, symptom, and functioning. Psoriasis severity was assessed using the psoriasis area severity index (PASI). Levels of perceived stress, patient knowledge about psoriasis, and patient satisfaction were also assessed. Follow-up evaluations were performed at 3, 6, and 12 months. <b><i>Results:</i></b> A total 142 patients formed the intention-to-treat population: 70 in the control group and 72 in the intervention group. Skindex component scores and the PASI were significantly lower at 3, 6, and 12 months as compared to baseline in both groups, but no significant differences were found between the groups. Knowledge about psoriasis improved significantly during follow-up amongst patients from the intervention group compared to controls (68% of correct answers vs. 56%; <i>p</i> &#x3c; 0.01). Patient satisfaction with psoriasis management and treatment was also better in the intervention group. <b><i>Conclusions:</i></b> The standardised education programme did not improve HRQoL and disease severity in psoriasis, but led to a significant improvement in patient knowledge about the disease and increased patient satisfaction.

A Randomised Controlled Study of Low-Dose High-Frequency In-Situ Simulation Training to Improve Newborn Resuscitation

Positive pressure ventilation of the non-breathing newborn is a critical and time-sensitive intervention, considered to be the cornerstone of resuscitation. Many healthcare providers working in delivery units in high-resource settings have little opportunity to practise this skill in real life, affecting their performance when called upon to resuscitate a newborn. Low-dose, high-frequency simulation training has shown promise in low-resource settings, improving ventilation performance and changing practice in the clinical situation. We performed a randomised controlled study of low-dose, high-frequency simulation training for maintenance of ventilation competence in a multidisciplinary staff in a busy teaching hospital in Norway. We hypothesised that participants training according to a low-dose, high-frequency protocol would perform better than those training as they wished. Our results did not support this, although the majority of protocol participants were unable to achieve training targets. Subgroup analysis comparing no training to at least monthly training did identify a clear benefit to regular simulation practice. Simulated ventilation competence improved significantly for all participants over the course of the study. We conclude that frequent, short, simulation-based training can foster and maintain newborn ventilation skills in a multidisciplinary delivery unit staff in a high-resource setting.

Treatment of urinary incontinence in women with chronic obstructive pulmonary disease—a randomised controlled study

Background Little is known regarding treatment of urinary incontinence (UI) in women with chronic obstructive pulmonary disease (COPD). The aim of the study was to explore the efficacy of pelvic floor muscle training (PFMT) or cough-suppression techniques (CST) on UI in women with COPD. Methods A three-armed, two-centred, single-blinded, randomised controlled study was performed. Subjects were randomised to (a) PFMT for 16 weeks, (b) 2–3 educational sessions in CST, or (c) written information only. All participants completed questionnaires about UI, cough symptoms, and health status and underwent clinical examinations to evaluate the strength of the pelvic floor muscles and exercise capacity. Daily physical activity levels were measured using an activity monitor and lung function with spirometry. With a significance level of 5% and an 80% chance of detecting a significant difference between groups of 2.5 points on the ICIQ UI SF score, our sample size calculation showed that a total of 78 women, 26 in each group, was required to complete the study. Results During the period 2016 to 2018, 95 women were invited to the study. A total of 42 were recruited, three were excluded and 10 (24%) dropped out during the follow-up period. Mean ICIQ-UI SF total baseline score was 9.6 (range: 1–17) and 7.0 (range: 0–16) at follow-up. Changes in subjective UI as measured with the ICIQ-UI SF questionnaire were seen in the PFMT group and control group, but not in the CST group. Conclusion Due to the low number of available participants and recruitment difficulties including practical issues such as travel distance, lack of interest, poor state of health, and high number of comorbidities, our results are inconclusive. However, reduced subjective UI was observed in the PFMT and control groups with a trend towards best effect in the PFMT group. Screening for UI is advisable in all women with COPD to be able to identify and treat these women to reduce symptom burden and improve quality of life. Future studies should focus on barriers to recruitment as well as randomised controlled studies with larger sample sizes. Trial registration ClinicalTrials.gov NCT02614105. 25th November 2015.