Indirect language therapy for children with persistent language impairment in mainstream primary schools : outcomes from a cohort intervention

A manualized language therapy developed via a randomized controlled trial had proved efficacious in the short-term in developing expressive language for mainstream primary school children with persistent language impairment. This therapy had been delivered to a predetermined schedule by speech and language therapists or speech and language therapy assistants to children individually or in groups. However, this model of service delivery is no longer the most common model in UK schools, where indirect consultancy approaches with intervention delivered by school staff are often used. A cohort study was undertaken to investigate whether the therapy was equally efficacious when delivered to comparable children by school staff, rather than speech and language therapists or speech and language therapy assistants. Children in the cohort study were selected using the same criteria as in the randomized controlled trial, and the same manualized therapy was used, but delivered by mainstream school staff using a consultancy model common in the UK. Outcomes were compared with those of randomized controlled trial participants. The gains in expressive language measured in the randomized controlled trial were not replicated in the cohort study. Less language-learning activity was recorded than had been planned, and less than was delivered in the randomized controlled trial. Implications for 'consultancy' speech and language therapist service delivery models in mainstream schools are outlined

A Randomized Trial Comparing the Effect of Soy Protein Diet Supplement Versus Hospital Standard Supplement on Clinical and Laboratory Parameters in Malnutrition Patients

Background: Studies have shown that soy protein diet may improve clinical nutrition status of malnutrition patients. Soybeans itself are unique foods because of their rich nutrient content. The complete nutrient in soybean is important and also offers many health benefits especially in malnutrition patient during hospitalization. Objective: The objective of this study was to assess the effect of soy protein supplement and hospital standard supplement (animal protein) on anthropometries and laboratory findings in malnutrition patients during hospitalization. Method: Forty-eight patients with malnutrition (confirmed by Body Mass Index < 20 kg/m2) aged 14- 70 years old were recruited from Internal Medicine wards in Cipto Mangunkusumo hospital, Jakarta, Indonesia. The study design was randomized controlled trial. The subjects were randomly divided into 2 groups were fed supplement diet contained soy protein supplement diet (40 g/d) or hospital standard supplement (40 g/d) for 2 weeks. Body weight was measured in the first day (base line data), 7-dayand 14-day after intervention. Blood and urine was collected at baseline, 7-day and 14-day for measuring transferin, prealbumin and nitrogen balance. The intake of supplement, gastrointestinal symptoms and others adverse event were noted every day. Result: From 48 subjects, there were only 32 patients that completed the study during 2 weeks. In the base line data there were no significant different for intake diet calculation, anthropometrics and laboratory parameters in study group and control group. A total of patients 32 consist of 20 (62,5 %) female and 12 (37,5%) male with a mean age 31,8 + 12,9 years old. Anthropometrics evaluation after 1 week and 2 weeks intervention in soy protein supplement showed significantly increased every week in 2 weeks. In control group, significantly increased showed only after two weeks intervention. But there was no significantly increased of BMI of two groups. Serum transferin concentration increased from 1,489 ± 0,502 at base line to be 1,600 ± 0,502 at week 1 and to bel, 695 ± 0,402 in study group. But this increasing was no significantly between two groups. No significant differences were found between two groups for prealbumin level after 1 week and 2 weeks intervention. Nitrogen balance improved significantly (p<0,05) more with soy protein supplement than hospital standard supplement (animal protein). In this study, there was no side effect in soy protein supplement diet and 1 case with diarrhea and nausea in hospital standard supplement (animal protein) Conclusion: Soy protein supplement diet improved both of nutrition parameter: anthropometrics and laboratory parameter. There were no significantly different in anthrometrics and laboratory parameter berween soy protein supplements tahan hospital standar supplement (animal protein). But nitrogen balance improved significantly in study group than control group. Substitution of soy protein for animal protein has the potential role for the patient with malnutritio

Reply - Letter to the Editor - Malnutrition: The kiss of grim reaper

Conducting a large, multicenter, prospective, randomized clinical trial poses a number of challenges. In particular, the successful completion of the trial is based on devising a protocol which could yield to clinically relevant answers yet no becoming so complex and sophisticated to prevent centers' participation and patients' enrollment. Consequently, the methodology of any trial reflects the clinical questions it tries to address

Beyond A/B Testing: Sequential Randomization for Developing Interventions in Scaled Digital Learning Environments

Randomized experiments ensure robust causal inference that are critical to effective learning analytics research and practice. However, traditional randomized experiments, like A/B tests, are limiting in large scale digital learning environments. While traditional experiments can accurately compare two treatment options, they are less able to inform how to adapt interventions to continually meet learners' diverse needs. In this work, we introduce a trial design for developing adaptive interventions in scaled digital learning environments -- the sequential randomized trial (SRT). With the goal of improving learner experience and developing interventions that benefit all learners at all times, SRTs inform how to sequence, time, and personalize interventions. In this paper, we provide an overview of SRTs, and we illustrate the advantages they hold compared to traditional experiments. We describe a novel SRT run in a large scale data science MOOC. The trial results contextualize how learner engagement can be addressed through inclusive culturally targeted reminder emails. We also provide practical advice for researchers who aim to run their own SRTs to develop adaptive interventions in scaled digital learning environments

Randomized double-blind placebo-controlled trial of 40 mg/day of atorvastatin in reducing the severity of sepsis in ward patients (ASEPSIS Trial)

Introduction: Several observational studies suggest that statins modulate the pathophysiology of sepsis and may prevent its progression. The aim of this study was to determine if the acute administration of atorvastatin reduces sepsis progression in statin naïve patients hospitalized with sepsis. Methods: A single centre phase II randomized double-blind placebo-controlled trial. Patients with sepsis were randomized to atorvastatin 40 mg daily or placebo for the duration of their hospital stay up to a maximum of 28-days. The primary end-point was the rate of sepsis progressing to severe sepsis during hospitalization. Results: 100 patients were randomized, 49 to the treatment with atorvastatin and 51 to placebo. Patients in the atorvastatin group had a significantly lower conversion rate to severe sepsis compared to placebo (4% vs. 24% p = 0.007.), with a number needed to treat of 5. No significant difference in length of hospital stay, critical care unit admissions, 28-day and 12-month readmissions or mortality was observed. Plasma cholesterol and albumin creatinine ratios were significantly lower at day 4 in the atorvastatin group (p < 0.0001 and p = 0.049 respectively). No difference in adverse events between the two groups was observed (p = 0.238). Conclusions: Acute administration of atorvastatin in patients with sepsis may prevent sepsis progression. Further multi-centre trials are required to verify these findings. Trial Registration: International Standard Randomized Control Trial Registry ISRCTN64637517