Predicting treatment outcomes for bilinguals with aphasia using computational modeling: Study protocol for the PROCoM randomised controlled trial

IntroductionBilinguals with aphasia (BWA) present varying degrees of lexical access impairment and recovery across their two languages. Because both languages may benefit from therapy, identifying the optimal target language for treatment is a current challenge for research and clinical practice. Prior research has demonstrated that the BiLex computational model can accurately simulate lexical access in healthy bilinguals, and language impairment and treatment response in bilingual aphasia. Here, we aim to determine whether BiLex can predict treatment outcomes in BWA in the treated and the untreated language and compare these outcome predictions to determine the optimal language for rehabilitation.Methods and analysisThe study involves a prospective parallel-group, double-blind, randomised controlled trial. Forty-eight Spanish–English BWA will receive 20 sessions of semantic treatment for lexical retrieval deficits in one of their languages and will complete assessments in both languages prior and after treatment. Participants will be randomly assigned to an experimental group receiving treatment in the optimal language determined by the model or a control group receiving treatment in the language opposite to the model’s recommendation. Primary treatment outcomes include naming probes while secondary treatment outcomes include tests tapping additional language domains. Treatment outcomes will be compared across the two groups using 2×2 mixed effect models for repeated measures Analysis of variance (ANOVA) on metrics of treatment effects commonly employed in rehabilitation studies (ie, effect size and percentage change).Ethics and disseminationAll procedures included in this protocol (protocol number 29, issue date: 19 March 2019) were approved by the Boston University Charles River Campus Institutional Review Board at Boston, Massachusetts (reference number: 4492E). The results of this study will be published in peer-reviewed scientific journals and will be presented at national and international conferences.Trial registration numberNCT02916524.

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Rationale and design for Lowering-hyperUricaemia treatment on cardiovascular outcoMes In peritoNeal diAlysis patients: a prospective, multicentre, double-blind, randomised controlled trial (LUMINA)

BMJ Open ◽

10.1136/bmjopen-2020-037842 ◽

2020 ◽

Vol 10 (10) ◽

pp. e037842

Author(s):

Wei Chen ◽

Naya Huang ◽

Haiping Mao ◽

Xiao Yang ◽

Qian Zhou ◽

...

Keyword(s):

Peritoneal Dialysis ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Dropout Rate ◽

Cardiovascular Outcomes ◽

Control Group ◽

Type I ◽

Dialysis Patients ◽

Double Blind ◽

Randomised Controlled

IntroductionThe prevalence of hyperuricaemia in peritoneal dialysis patients is quite high. Studies have demonstrated a correlation between hyperuricaemia and cardiovascular disease and treatment of hyperuricaemia reportedly reduces cardiovascular risk in patients with chronic kidney disease. However, whether hyperuricaemia treatment benefits cardiovascular outcomes in continuous ambulatory peritoneal dialysis (CAPD) patients is not yet known.Methods and analysesThis prospective, multicentre, double-blind, randomised controlled trial was designed to evaluate the effects of hyperuricaemia treatment on cardiovascular event risk in CAPD patients. Based on a power of 80%, with type I error α=0.05, two-sided test and 1:1 parallel control study, considering a dropout rate of 20%, a total of 548 eligible patients are expected to be randomly assigned to either the hyperuricaemia treatment group (febuxostat) or control group (placebo).Ethics and disseminationThis study has been approved by the Medical Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University and the ethics committees of other participating institutions. Written informed consent will be obtained from potential trial participants or authorised surrogates.The findings of the study will be disseminated through publications in peer-reviewed journals, and presentations at national and international conferences.Trial registration numberNCT03200210. 25 June 2017. The trial was started on 13 July 2017, and is expected to end by 31 December 2022. Till 20 Jan 2020, a total of 548 patients have been recruited.Protocol versionThe protocol version number and date are YLT-1604-V2.0 and 15 December 2016.

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Effectiveness of a lumbopelvic monitor and feedback device to change postural behaviour: the ELF cluster randomised controlled trial

Occupational and Environmental Medicine ◽

10.1136/oemed-2019-106293 ◽

2020 ◽

Vol 77 (7) ◽

pp. 462-469

Author(s):

Daniel Cury Ribeiro ◽

Stephan Milosavljevic ◽

Jane Terry ◽

J H Abbott

Keyword(s):

Randomised Controlled Trial ◽

Repeated Measures ◽

Healthcare Workers ◽

Controlled Trial ◽

Random Allocation ◽

Audio Feedback ◽

Feedback Group ◽

Mixed Effect ◽

Forward Bending ◽

Randomised Controlled

ObjectivesThe aim of this clustered, randomised controlled trial was to assess the effectiveness of a lumbopelvic postural feedback device for changing postural behaviour in a group of healthcare workers. We hypothesised that workers exposed to auditory postural feedback would reduce the number of times forward bending posture is adopted at work.MethodsThis was a participant and assessor blinded, randomised, sham-controlled trial with blocked cluster random allocation. We recruited healthcare workers from aged care institutions. Healthcare sites were randomly allocated to the feedback or sham group (SG). A postural monitoring and feedback device was used to monitor and record lumbopelvic forward bending posture, and provided audio feedback whenever the user sustained lumbopelvic forward bending posture that exceeded predefined thresholds. The primary outcome measure was postural behaviour (exceeding thresholds). We used a robust variant of repeated measures mixed-effect model for assessing within-group and between-group differences in postural behaviour.ResultsWe recruited 19 sites, and 130 healthcare workers participated. There were no within-group changes on the number of times postural threshold was exceeded at 1-week follow-up (feedback group: −0.7, 95% CI −2.61 to 0.72; SG −0.3, −1.65 to 0.98), and no differences (0.05, 95% CI −1.83 to 1.94) between SG and feedback group.ConclusionsFindings from this trial indicate that audio feedback provided by a postural monitor device did not reduce the number of times healthcare workers exceeded the postural threshold.Trial registration numberACTRN12616000449437.

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The effect of zinc supplementation on pregnancy outcomes: a double-blind, randomised controlled trial, Egypt

British Journal Of Nutrition ◽

10.1017/s000711451500166x ◽

2015 ◽

Vol 114 (2) ◽

pp. 274-285 ◽

Cited By ~ 10

Author(s):

Samia A. Nossier ◽

Noha E. Naeim ◽

Nawal A. El-Sayed ◽

Azza A. Abu Zeid

Keyword(s):

Randomised Controlled Trial ◽

Pregnant Women ◽

Pregnancy Outcomes ◽

Controlled Trial ◽

Neonatal Morbidity ◽

Control Group ◽

Double Blind ◽

Serum Zn ◽

Randomised Controlled ◽

Low Serum

The present randomised controlled trial (RCT) was conducted to evaluate the effect of two regimens of Zn supplementation on pregnancy outcomes in Alexandria, Egypt. Healthy pregnant women aged 20–45 years and having low serum Zn level below the estimated median for the gestational age were eligible to participate in the trial. Of 1055 pregnant women assessed for the eligibility of low serum Zn level, 675 were eligible. These women were randomly assigned to one of the three groups: the Zn alone group (n 225) received a daily dose of 30 mg ZnSO4, the combined group (n 227) received 30 mg ZnSO4 plus multivitamins (B1, B6, D3, C and E) and the control group (n 223) received placebo (270 mg lactose). They were followed up from the time of recruitment till 1 week after delivery. Overall, there was no detectable difference in the mean birth weight between the three groups (mean 2929·12 (sd 330·28), 2922·22 (sd 324·05) and 2938·48 (sd 317·39) g for the placebo, Zn and Zn plus multivitamin groups, respectively, P= 0·88). Both the single and the combined Zn supplements were almost equally effective in reducing second- and third-stage complications (relative risk (RR) 0·43, 95 % CI 0·31, 0·60 for the Zn group and RR 0·54, 95 % CI 0·40, 0·73 for the combined group). Stillbirth and preterm delivery were significantly lower among the two supplemented groups than the placebo group (P= 0·001). Early neonatal morbidity was also significantly lower in the supplemented groups (RR 0·23, 95 % CI 0·15, 0·35 for the Zn group and RR 0·25, 95 % CI 0·16, 0·37 for the combined group). Collectively, Zn supplementation was effective in reducing pregnancy complications and early neonatal infection among the Zn-deficient women of the present trial.

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Buddy-motivational interviewing (buddy-MI) to Increase Physical Activity in Community Settings: Results of a Pragmatic Randomised Controlled Trial

Motivational Interviewing Training Research Implementation Practice ◽

10.5195/mitrip.2014.49 ◽

2015 ◽

Vol 1 (3) ◽

pp. 31-37

Author(s):

David Brinson ◽

Mark Wallace-Bell ◽

Ray Kirk ◽

Andrew Hornblow

Keyword(s):

Physical Activity ◽

Randomised Controlled Trial ◽

Motivational Interviewing ◽

Repeated Measures ◽

Controlled Trial ◽

Control Group ◽

Ripple Effects ◽

Parallel Group ◽

Development Evaluation ◽

Randomised Controlled

This article describes the implementation and evaluation of a novel buddy-Motivational Interviewing intervention intended to help apparently healthy but relatively sedentary adults to adopt and maintain regular physical activity for health and fitness. This intervention is an adaptation of Motivational Interviewing which adds client-selected motivational-buddies who can provide in-session input as well as ongoing out-of-session support focused on strengthening client’s motivation for and movement toward their physical activity goals. A pragmatic parallel-group randomised controlled trial with 12-month follow-up was implemented to test the intervention. The trial demonstrated that buddy-MI was feasible and could be delivered with equivalent fidelity to standard MI and both groups demonstrated statistically significant changes across a range of behavioural and health-status outcomes. Moreover, the experimental group participants generally ‘outperformed’ the control group participants as shown by the consistent trends observed over three repeated measures out to 12-months (although these between-group differences were statistically non-significant). Qualitative data indicated participant acceptance of the programme as well as providing initial evidence of positive collateral health effects (‘ripple effects’ whereby buddies changed their behaviours also). Consideration for further development, evaluation and applications are also discussed.

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Effect of Lactobacillus gasseri SBT2055 in fermented milk on abdominal adiposity in adults in a randomised controlled trial

British Journal Of Nutrition ◽

10.1017/s0007114513001037 ◽

2013 ◽

Vol 110 (9) ◽

pp. 1696-1703 ◽

Cited By ~ 110

Author(s):

Yukio Kadooka ◽

Masao Sato ◽

Akihiro Ogawa ◽

Masaya Miyoshi ◽

Hiroshi Uenishi ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Visceral Fat ◽

Dose Group ◽

Controlled Trial ◽

Fermented Milk ◽

Control Group ◽

Abdominal Adiposity ◽

Double Blind ◽

Lactobacillus Gasseri ◽

Randomised Controlled

Consumption of fermented milk (FM) containing a probiotic, Lactobacillus gasseri SBT2055 (LG2055), previously showed a reduction in abdominal adiposity in a randomised controlled trial (RCT) using FM with 108 colony-forming units (cfu) of LG2055/g. However, whether the effectiveness is observed at lower concentrations, the recommended minimum or intermediate levels of probiotics (106 or 107cfu/g, respectively), remains to be examined. A multi-centre, double-blind, parallel-group RCT was conducted using 210 healthy Japanese adults with large visceral fat areas (80·2–187·8 cm2). They were balanced for their baseline characteristics and randomly assigned to three groups receiving FM containing 107, 106 or 0 (control) cfu LG2055/g of FM, and were asked to consume 200 g FM/d for 12 weeks. Abdominal visceral fat areas, which were determined by computed tomography, at week 12, changed from baseline by an average of − 8·5 % (95 % CI − 11·9, − 5·1; P< 0·01) in the 107 dose group, and by − 8·2 % (95 % CI − 10·8, − 5·7; P< 0·01) in the 106 dose group. Other measures including BMI, waist and hip circumferences, and body fat mass were also significantly decreased from baseline at week 12 in both groups; interestingly, the cessation of taking FM for 4 weeks attenuated these effects. In the control group, none of these parameters significantly decreased from baseline. These findings demonstrate that consumption of LG2055 at doses as low as the order of 108cfu/d exhibited a significant lowering effect on abdominal adiposity, and suggest that constant consumption might be needed to maintain the effect.

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