Computer therapy combined with non-invasive brain stimulation for sentence processing difficulties in post-stroke aphasia: a randomised control trial (the UTILISE study)

Background: We explore the efficacy of a new computer therapy for sentence comprehension and production impairments in post-stroke aphasia. The intervention is based upon the theoretical framework of usage-based Construction Grammar, which has yet to be systematically applied to the management of sentence processing disorders in aphasia. Components of the intervention were trialled in two small case series, with the results of one pilot used to inform a power calculation. The aims of the study are: (1) To determine if UTILISE therapy (Unification Therapy Integrating LexIcon and SEntences) for aphasic sentence processing impairment is more effective than usual care; (2) To determine if non-invasive transcranial direct current stimulation (tDCS) enhances treatment outcomes; (3) To determine if improvements are evident in functional use of language after treatment; (4) To determine if any treatment effects are apparent after an 8-week maintenance period. Methods: We will conduct a Phase II prospective randomised control trial. The behavioural component of the study (computer therapy) is single-blinded on the primary outcome measure, while the tDCS element is double-blinded. The trial is conducted within a university setting and aims to recruit 66 participants with post-stroke aphasia from community and post-acute rehabilitation settings. After first baseline evaluation, participants are randomised on a 2:2:1:1 basis to one of four conditions: 1) immediate treatment + active tDCS; 2) immediate treatment + sham tDCS; 3) deferred treatment + active tDCS; 4) deferred treatment + sham tDCS. A second baseline assessment is completed prior to start of treatment with a gap of four weeks between baselines for the immediate groups, and eight weeks for the deferred groups. The deferred trial entry conditions act as a usual care control across their extended baseline phase. Treatment is administered in 12 x 60-minute sessions over a four-week period. Outcomes are assessed immediately at the end of intervention and after an eight week no treatment period. Participants will also undergo a structural magnetic resonance (MR) brain scan to determine lesion location and extent. The primary outcome measure is degree of connectivity (ratio of three-word combinations to total number of words) in spontaneous narrative speech (personal narratives and narration of picture cartoon series). Speech samples will be audio-recorded and subsequently transcribed and tagged by raters blind to allocation and phase. Analysis will be performed by automated analysis software (Frequency in Language Analysis Tool, FLAT; Zimmerer, Newman, Thomson, Coleman, & Varley, 2018). Secondary outcome measures are spoken sentence comprehension (Test of Reception of Grammar, TROG-2; Bishop, 2003), a study-specific story completion test (adapted from Goodglass, Gleason, Ackerman Bernholtz, & Hyde, 1972), and the Stroke and Aphasia Quality of Life Scale (SAQOL-39; Hilari, Byng, Lamping, & Smith, 2003). A shortened form of a written synonym judgement task (adapted from the Action for Dysphasic Adults Auditory Comprehension Battery, A.D.A.; Franklin, Turner, & Ellis, 1992) is administered as a probe of an untreated behaviour.Discussion: In a series of planned comparisons, we will first determine the stability of behaviour between the two baseline evaluations. We will examine the efficacy of UTILISE through comparison of change in scores between the immediate and deferred entry group, and subsequent maintenance of any behavioural gains by change between the immediate outcome and the follow-up maintenance measures. We will explore the effect of active vs. sham tDCS, and the relationship between outcomes and demographic and behavioural profiles, and lesion size and location.

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Supporting self-management amongst young people with acne vulgaris: feasibility randomised trial of a web-based behavioural intervention (Preprint)

10.2196/preprints.25918 ◽

2020 ◽

Author(s):

Athena Ip ◽

Ingrid Muller ◽

Adam Geraghty ◽

Kate Rumsby ◽

Beth Stuart ◽

...

Keyword(s):

Young People ◽

Usual Care ◽

Primary Outcome ◽

Outcome Measure ◽

Randomised Trial ◽

Intervention Group ◽

Primary Outcome Measure ◽

Self Management ◽

Web Based ◽

Topical Treatments

BACKGROUND Acne is a common skin condition that is most prevalent in young people. It can have substantial impact on quality of life, which can be minimised with appropriate use of topical treatments. Nonadherence to topical treatments for acne is common often leading to treatment failure. OBJECTIVE The objective of this study was to develop a web-based behavioural intervention to support self-management of acne and to assess the feasibility of recruitment, retention and engagement in a parallel unblinded randomised trial of the intervention compared with usual care alone. METHODS The intervention was developed iteratively using LifeGuide software and following the Person-Based Approach (PBA) to intervention development. The target behaviour was ‘Appropriate use of topical treatments’ and barriers and facilitators identified from the qualitative research and evidence from the wider literature were used to identify techniques to improve and promote their use. Young people with acne aged 14-25 years who had received treatment for acne within the last 6 months were invited to participate through mail-out from primary care practices in the South of England. Participants were randomised to: (1) usual care, or (2) usual care plus access to web-based intervention. Usage data was collected and a series of questionnaires including the primary outcome measure for skin specific quality of life (Skindex-16) were collected at baseline, 4-weeks and 6-weeks follow-up. RESULTS A total of 1193 participants were invited and 53 young people with acne were randomised to usual care (n=27) or usual care plus intervention (n=26). The response rate for the primary outcome measure (Skindex-16) was 87% at 4-weeks, 6-weeks or both time points. The estimate of mean scores between groups (with 95% confidence) using linear regression showed a trend in the direction of benefit for the web-based intervention group in the primary outcome measure (Skindex-16), and secondary measures (Patient Health Questionnaire 4 and the Problematic Experiences of Therapy Scale). Intervention usage data showed a high uptake of the core module in the usual care plus web-based intervention group with 23 of 26 (88%) completing the module. Uptake of the optional modules were low with less than half visiting each (Myth-busting quiz: 27%; Living with spots or acne: 42%; Oral antibiotics: 19%; What are spots or acne: 27%; Other treatments: 27%; Talking to your GP: 12%). CONCLUSIONS This study demonstrated the feasibility of delivering a trial of a web-based intervention to support self-management for young people with acne. Additional work is needed prior to a full definitive trial including enhancing engagement with the intervention, recruitment and follow-up rates. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 78626638; https://doi.org/10.1186/ISRCTN78626638.

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Utility-weighted modified Rankin Scale: Still too crude to be a truly patient-centric primary outcome measure?

International Journal of Stroke ◽

10.1177/1747493019830583 ◽

2019 ◽

Vol 15 (3) ◽

pp. 268-277 ◽

Cited By ~ 2

Author(s):

Venesha Rethnam ◽

Julie Bernhardt ◽

Helen Dewey ◽

Marj Moodie ◽

Hannah Johns ◽

...

Keyword(s):

Construct Validity ◽

Primary Outcome ◽

Outcome Measure ◽

Controlled Trial ◽

Intraclass Correlation ◽

Primary Outcome Measure ◽

Modified Rankin Scale ◽

Utility Values ◽

Post Stroke ◽

Over Time

Background The utility-weighted modified Rankin Scale (UW-mRS) is an outcome measure recently proposed to improve statistical efficiency and interpretability of the mRS. Statistical properties of the UW-mRS have been well investigated, but construct validity has yet to be established. Aims To investigate the construct validity of the UW-mRS as a primary outcome measure by assessing variability in utility values within and between mRS categories, over time post-stroke, and by different derivation methods. Methods UW-mRS was derived using assessment of quality of life (AQoL-4D) and mRS scores at 3 and 12 months ( n = 2030) from a large randomized controlled trial, A Very Early Rehabilitation Trial (AVERT). Receiver operator characteristic (ROC) analysis of AQoL-4D was conducted to differentiate between sequential mRS categories. Intraclass correlation was used to explore variability in utility values over time post-stroke, UW-mRS values, and derivation methods from multiple studies. Results UW-mRS values for mRS categories 0–6 at three months were 0.80, 0.78, 0.63, 0.37, 0.11, 0.03, and 0. Based on AQoL-4D utility values, areas under the ROC curve varied from 0.54 to 0.87. Time post-stroke explained 42%–56% of variability in AQoL-4D utility values in patients with no change in mRS between 3 and 12 months. The choice of the derivation method contributed to 25% of the variability in UW-mRS values. Conclusions The high variability in utility values between and within mRS categories, over time post-stroke, and using different derivation methods is not adequately reflected in the UW-mRS. These threats to construct validity warrant caution when using UW-mRS as a primary outcome measure. Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12606000185561).

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Clinical impact of left and right axis deviations with narrow QRS complex on 3-year outcomes in a hospital-based population in Japan

Scientific Reports ◽

10.1038/s41598-021-88259-8 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Yuta Seko ◽

Takao Kato ◽

Yuhei Yamaji ◽

Yoshisumi Haruna ◽

Eisaku Nakane ◽

...

Keyword(s):

Cardiovascular Events ◽

Primary Outcome ◽

Outcome Measure ◽

Conduction Block ◽

Primary Outcome Measure ◽

Excess Risk ◽

Major Adverse Cardiovascular Events ◽

Prognostic Impact ◽

Axis Deviation ◽

The Right

AbstractWhile the prognostic impact of QRS axis deviation has been assessed, it has never been investigated in patients without conduction block. Thus, we evaluated the prognostic impact of QRS-axis deviation in patients without conduction block. We retrospectively analyzed 3353 patients who had undergone both scheduled transthoracic echocardiography and electrocardiography in 2013 in a hospital-based population, after excluding patients with a QRS duration of ≥ 110 ms, pacemaker placement, and an QRS-axis − 90° to − 180° (northwest axis). The study population was categorized into three groups depending on the mean frontal plane QRS axis as follows: patients with left axis deviation (N = 171), those with right axis deviation (N = 94), and those with normal axis (N = 3088). The primary outcome was a composite of all-cause death and major adverse cardiovascular events. The cumulative 3-year incidence of the primary outcome measure was significantly higher in the left axis deviation group (26.4% in the left axis deviation, 22.7% in the right axis deviation, and 18.4% in the normal axis groups, log-rank P = 0.004). After adjusting for confounders, the excess risk of primary outcome measure remained significant in the left axis deviation group (hazard ratio [HR] 1.44; 95% confidence interval [CI] 1.07–1.95; P = 0.02), while the excess risk of primary outcome measure was not significant in the right axis deviation group (HR 1.22; 95% CI 0.76–1.96; P = 0.41). Left axis deviation was associated with a higher risk of a composite of all-cause death and major adverse cardiovascular events in hospital-based patients without conduction block in Japan.

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Computerised cognitive–behavioural therapy for adults with intellectual disability: randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.117.198630 ◽

2017 ◽

Vol 211 (2) ◽

pp. 95-102 ◽

Cited By ~ 13

Author(s):

Patricia Cooney ◽

Catherine Jackman ◽

David Coyle ◽

Gary O'Reilly

Keyword(s):

Intellectual Disability ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Outcome Measure ◽

Controlled Trial ◽

Behavioural Therapy ◽

Primary Outcome Measure ◽

Cognitive Behavioural ◽

Randomised Controlled

BackgroundDespite the evidence base for computer-assisted cognitive–behavioural therapy (CBT) in the general population, it has not yet been adapted for use with adults who have an intellectual disability.AimsTo evaluate the utility of a CBT computer game for adults who have an intellectual disability.MethodA 2 × 3 (group × time) randomised controlled trial design was used. Fifty-two adults with mild to moderate intellectual disability and anxiety or depression were randomly allocated to two groups: computerised CBT (cCBT) or psychiatric treatment as usual (TAU), and assessed at pre-treatment, post-treatment and 3-month follow-up. Forty-nine participants were included in the final analysis.ResultsA significant group x time interaction was observed on the primary outcome measure of anxiety (Glasgow Anxiety Scale for people with an Intellectual Disability), favouring cCBT over TAU, but not on the primary outcome measure of depression (Glasgow Depression Scale for people with a Learning Disability). A medium effect size for anxiety symptoms was observed at post-treatment and a large effect size was observed after follow-up. Reliability of Change Indices indicated that the intervention produced clinically significant change in the cCBT group in comparison with TAU.ConclusionsAs the first application of cCBT for adults with intellectual disability, this intervention appears to be a useful treatment option to reduce anxiety symptoms in this population.

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Erosive progression is minimal, but erosion healing rare, in patients with rheumatoid arthritis treated with adalimumab. A 1 year investigator-initiated follow-up study using high-resolution computed tomography as the primary outcome measure

Annals of the Rheumatic Diseases ◽

10.1136/ard.2008.097048 ◽

2008 ◽

Vol 68 (10) ◽

pp. 1585-1590 ◽

Cited By ~ 61

Author(s):

U M. Dohn ◽

A Boonen ◽

M L Hetland ◽

M S Hansen ◽

L S Knudsen ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Computed Tomography ◽

High Resolution ◽

Primary Outcome ◽

Outcome Measure ◽

Primary Outcome Measure ◽

High Resolution Computed Tomography ◽

Follow Up Study ◽

Erosive Progression

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Telephone-guided self-help for mental health difficulties in neurological conditions: a randomised pilot trial

Archives of Disease in Childhood ◽

10.1136/archdischild-2019-318577 ◽

2021 ◽

pp. archdischild-2019-318577

Author(s):

Sophie D Bennett ◽

Isobel Heyman ◽

Anna E Coughtrey ◽

Sophia Varadkar ◽

Terence Stephenson ◽

...

Keyword(s):

Mental Health ◽

Young People ◽

Primary Outcome ◽

Outcome Measure ◽

Mental Health Problems ◽

Pilot Trial ◽

Primary Outcome Measure ◽

Self Help ◽

Mental Health Difficulties ◽

Neurological Conditions

ObjectiveThis study aimed to conduct a randomised pilot trial to assess the feasibility of a randomised controlled trial (RCT) to investigate the effect of telephone-guided self-help for the treatment of mental health difficulties in children with neurological conditions.DesignPreliminary RCT. The primary outcome measure was the Strengths and Difficulties Questionnaire.SettingNeurology clinics in a national tertiary paediatric hospital.PatientsYoung people attending neurology clinics who met criteria for mental health difficulties according to the Development and Wellbeing Assessment.Interventions12 weeks of telephone-guided self-help based on a modular approach to psychological therapy for children delivered to children and/or their parents (n=17; eight males; mean age 12.04 years, SD=3.34) or a waiting list for telephone-guided self-help with no additional intervention over 12 weeks (n=17; nine males; mean age 10.53 years, SD=3.14).Results124 participants completed the DAWBA, and 34 children and young people were entered into the trial. 65% of those randomised to the intervention arm completed the full intervention, and the intervention was acceptable to those completing it. However, there were significant problems related to lack of data completion (38% data loss for primary outcome measure), choice of control comparator and outcome measures. Due to significant loss of data at follow-up, the effect size findings are considered unreliable.ConclusionsFurther feasibility work should be conducted to improve data completeness before progression to a definitive trial of guided self-help for mental health problems in children with neurological conditions can be recommended.Trial registration numberISRCTN21184717.

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COMPARISON RESULTS OF SURGICAL TREATMENT LOCALIZED AND EXTENDED UTERINE CANCER

Clinical Practice ◽

10.17816/clinpract1356-61 ◽

2010 ◽

Vol 1 (3) ◽

pp. 56-61

Author(s):

I I Ushakov ◽

E A Artoshina ◽

P G Brousov ◽

I V Nazvantsev ◽

S A Levakov ◽

...

Keyword(s):

Surgical Treatment ◽

High Risk ◽

Adjuvant Radiotherapy ◽

Primary Outcome ◽

Outcome Measure ◽

Uterine Cancer ◽

Primary Outcome Measure ◽

Pelvic Lymphadenectomy ◽

Peritoneal Washing ◽

Comparison Results

We selected 145 patients with endometrial carcinoma who had been treated with standard surgery (hysterectomy and BSO, peritoneal washing, palpation pelvic and para-aortic nodes) and with complete systematic pelvic lymphadenectomy (n=30 patients) or combined pelvic and para-aortic lymphadenectomy (n=30). Patients at intermediate or high risk of recurrence were offered adjuvant radiotherapy. The primary outcome measure was results of the surgical therapy.

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The efficacy of interactive, motion capture-based rehabilitation on functional outcomes in an inpatient stroke population: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215517720790 ◽

2017 ◽

Vol 32 (2) ◽

pp. 191-200 ◽

Cited By ~ 12

Author(s):

John Cannell ◽

Emelyn Jovic ◽

Amy Rathjen ◽

Kylie Lane ◽

Anna M Tyson ◽

...

Keyword(s):

Usual Care ◽

Motion Capture ◽

Stroke Rehabilitation ◽

Primary Outcome ◽

Intervention Group ◽

Step Test ◽

Controlled Clinical Trial ◽

Post Stroke ◽

Randomized Controlled ◽

Functional Reach

Objective: To compare the efficacy of novel interactive, motion capture-rehabilitation software to usual care stroke rehabilitation on physical function. Design: Randomized controlled clinical trial. Setting: Two subacute hospital rehabilitation units in Australia. Participants: In all, 73 people less than six months after stroke with reduced mobility and clinician determined capacity to improve. Interventions: Both groups received functional retraining and individualized programs for up to an hour, on weekdays for 8–40 sessions (dose matched). For the intervention group, this individualized program used motivating virtual reality rehabilitation and novel gesture controlled interactive motion capture software. For usual care, the individualized program was delivered in a group class on one unit and by rehabilitation assistant 1:1 on the other. Main measures: Primary outcome was standing balance (functional reach). Secondary outcomes were lateral reach, step test, sitting balance, arm function, and walking. Results: Participants (mean 22 days post-stroke) attended mean 14 sessions. Both groups improved (mean (95% confidence interval)) on primary outcome functional reach (usual care 3.3 (0.6 to 5.9), intervention 4.1 (−3.0 to 5.0) cm) with no difference between groups ( P = 0.69) on this or any secondary measures. No differences between the rehabilitation units were seen except in lateral reach (less affected side) ( P = 0.04). No adverse events were recorded during therapy. Conclusion: Interactive, motion capture rehabilitation for inpatients post stroke produced functional improvements that were similar to those achieved by usual care stroke rehabilitation, safely delivered by either a physical therapist or a rehabilitation assistant.

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