Study protocol for a randomised placebo-controlled trial of pramipexole in addition to mood stabilisers for patients with treatment resistant bipolar depression (the PAX-BD study).

BACKGROUND: Treatment Resistant Bipolar Depression (TRBD) is a major contributor to the burden of disease associated with Bipolar Disorder (BD). Treatment options for people experiencing bipolar depression are limited to three interventions listed by National Institute for Health and Care: lamotrigine, quetiapine and olanzapine, of which the latter two are often not well tolerated. The majority of depressed people with BD are therefore prescribed antidepressants despite limited efficacy. This demonstrates an unmet need for additional interventions. Pramipexole has been shown to improve mood symptoms in animal models of depression, in people with Parkinson's Disease and two proof of principle trials of pramipexole for people with BD who are currently depressed. METHODS: The PAX-BD study, funded by the United Kingdom (UK) National Institute for Health Research, aims to extend previous findings by assessing the efficacy, safety and health economic impact of pramipexole in addition to mood stabilisers for patients with TRBD. A randomised, double-blind, placebo controlled design is conducted in a naturalistic UK National Health Service setting. An internal pilot study to examine feasibility and acceptability of the study design is included. Participants with TRBD are screened from National Health Service secondary care services in up to 40 mental health trusts in the UK, with the aim of recruiting approximately 414 participants into a pre-randomisation phase to achieve a target of 290 randomised participants. Primary safety and efficacy measures are at 12 weeks following randomisation, with follow up of participants to 52 weeks. The primary outcome is depressive symptoms as measured by Quick Inventory for Depressive Symptomatology - Self Report. Secondary outcomes include changes in anxiety, manic symptoms, tolerability, acceptability, quality of life and cost-effectiveness. Outcome measures are collected remotely using self-report tools implemented online, and observer-rated assessments conducted via telephone. ANCOVA will be used to examine the difference in rating scale scores between treatment arms, and dependent on compliance in completion of weekly self-report measures. A mixed effects linear regression model may also be used to account for repeated measures. TRIAL REGISTRATION: ISRCTN72151939. Registered on 28 August 2019, http://www.isrctn.com/ISRCTN72151939 Protocol Version: 04-FEB-2021, Version 9.0.

Ultrasound localization of a tunneled leech beneath a microvascular scalp reconstruction: A case report.

Medicinal leech therapy is a common adjuvant modality used to treat venous congestion following threatened microvascular anastomosis. Migration and tunneling of a leech beneath a surgical reconstruction is a rare event that is seldom mentioned in the literature and worthy of further discussion. We present a rectus abdominus myocutaneous free tissue transfer that was used to cover a large alloplastic cranioplasty following resection of a previously radiated skull base malignant meningioma. The flap became congested postoperatively and required leech therapy after surgical salvage. Three days after flap salvage, the subject was once again brought back to the operating room for surgical exploration when a leech was witnessed to migrate beneath the threatened free flap. Duplex ultrasound was used intra-operatively to localize the leech 12 cm from its bite and assist with its successful removal. Tunneling of the leech beneath the flap is a rare complication, and localization underneath a myofascial or myocutaneous flap may be difficult. Duplex ultrasound is a simple and reliable method to localize the leech and allow for its removal through a minimal access incision.

Discrimination Skills Predict Effective Preference Assessment Methods for Adults with Developmental Disabilities.

We examined the relationship between three discrimination skills (visual, visual matching-to-sample, and auditory-visual) and four stimulus modalities (object, picture, spoken, and video) in assessing preferences of leisure activities for 7 adults with developmental disabilities. Three discrimination skills were measured using the Assessment of Basic Learning Abilities Test. Three participants mastered a visual discrimination task, but not visual matching-to-sample and auditory-visual discriminations; two participants mastered visual and visual matching-to-sample discriminations, but not auditory-visual discrimination, and two participants showed all three discriminations. The most and least preferred activities, identified through paired-stimulus preference assessment using objects, were presented to each participant in each of the four modalities using a reversal design. The results showed that (1) participants with visual discrimination alone showed a preference for their preferred activities in the object modality only; (2) those with visual and visual matching-to-sample discriminations, but not auditory-visual discrimination, showed a preference for their preferred activities in the object but not in the spoken modality, and mixed results in the pictorial and video modalities; and (3) those with all three discriminations showed a preference for their preferred activities in all four modalities. These results provide partial replications of previous findings on the relationship between discriminations and object, pictorial, and spoken modalities, and extend previous research to include video stimuli.

Predicting learning ability of people with intellectual disabilities: assessment of basic learning abilities test versus caregivers' predictions.

Two sets of predictions were compared concerning the ability of 20 adults with profound, severe, or moderate intellectual disabilities to learn 15 everyday tasks. Predictions were made by caregivers who had worked with the participants for a minimum of 24 months and consideration of participant performance on the Assessment of Basic Learning Abilities (ABLA) test. Standardized training procedures were used to attempt to teach each task to each participant until a pass or fail criterion was met. Ninety-four percent of predictions based on ABLA performance were confirmed, and the ABLA was significantly more accurate for predicting client performance than were the caregivers. The utility of these results is discussed.

Predicting Optimal Preference Assessment Methods for Individuals with Developmental Disabilities.

The single-stimulus (SS) preference assessment procedure has been described as more appropriate than the paired stimulus (PS) procedure for "lower functioning" individuals, but this guideline's vagueness limits its usefulness. We administered the SS and PS preference assessment procedures with food items to seven individuals with severe or profound developmental disabilities who scored at level 2 of the Assessment of Basic Learning Abilities (ABLA) and seven who scored at ABLA level 3. Thirteen of the 14 participants also received these assessments (PS and SS), with non-food items. The two procedures were about equally effective for both groups, and with both types of stimuli, although the PS procedure produced more refined preference hierarchies. Most participants showed moderate to high correlations in preference scores between the two procedures for both food and non-food items. These results suggest that, for individuals who score at either ABLA level 2 or ABLA level 3, the SS and the PS procedures are equally likely to identify preferred stimuli.

Predicting the relative efficacy of verbal, pictorial, and tangible stimuli for assessing preferences of leisure activities.

We measured the relationships between choice stimulus modalities and three basic discriminations (visual, visual matching-to-sample, and auditory-visual) using the Assessment of Basic Learning Abilities test. Participants were 9 adults who had moderate to profound developmental disabilities. Their most and least preferred leisure activities, identified by prior preference assessments, were presented using choice stimuli in three modalities (tangibles, pictures, and verbal descriptions) in an alternating-treatments design. For 8 of the 9 participants, discrimination skills predicted the selections of choice stimuli associated with their preferred activities. The results suggest that choice stimulus modalities in preference assessment of leisure activities need to be matched to the discrimination skills of persons with developmental disabilities.

Experimental studies of psychological interventions with athletes in competitions: why so few?

During the past three decades, behavioral practitioners have been applying techniques to improve the performance of athletes. To what extent are interventions, designed to improve the directly and reliably measured performance of athletes in competitions, based on experimental demonstrations of efficacy? That is the question addressed by this review. All issues of three behavioral journals and seven sport psychology journals, from 1972 through 2002, were examined for articles that addressed the above question. Fifteen articles were found that met the inclusion criteria, yielding an average of only one published study every 2 years. This article reviews those articles, discusses reasons for the dearth of research in this area, and makes recommendations for much needed future research.

A novel use for suture button suspension: reconstruction of the dorsal ulnar ligament to treat thumb metacarpal dislocation.

There are numerous treatment algorithms that have been developed to treat thumb carpometacarpal (CMC) arthritis. A newer treatment option for these patients is CMC stabilization using suture button suspensionplasty. The authors of this case report have extensive experience with the suture-button suspensionplasty using the Mini TightRope CMC technique (Arthrex). We present a novel usage of the suture-button suspensionplasty to reconstruct the dorsal ulnar ligament (in contrast to the usual reconstruction of the volar beak ligament) to treat a patient with persistent thumb metacarpal dislocation at the CMC joint. Two separate patients are presented. One patient demonstrates volar beak ligament instability, and the other demonstrates dorsal ulnar ligament instability. Both patients' demographics and operative indications are described. The operative technique for the novel usage of the suture-button suspensionplasty is described. Operative results of the dorsal ulnar ligament reconstruction are reviewed. After suture-button suspension of the thumb metacarpal to the trapezium, the dorsal ulnar ligament has been reconstructed. The patient demonstrated stability of the thumb CMC joint without dorsal or radial dislocation. The authors of this case report present a novel usage of the suture-button suspensionplasty to treat a patient with proximal thumb metacarpal dislocation at the trapezial-metacarpal interface. This method, in contrast to the referenced method of volar beak ligament reconstruction, allows reconstruction of the dorsal ulnar ligament. This allows stabilization of the joint by preventing dorsal and radial dislocation of the metacarpal.

Visual-visual nonidentity matching assessment: a worthwhile addition to the assessment of basic learning abilities test.

The Assessment of Basic Learning Abilities test (ABLA) is a useful tool for choosing appropriate training tasks for persons with developmental disabilities. This test assesses the ease or difficulty with which persons are able to learn six hierarchically positioned discrimination tasks. A visual-visual nonidentity matching prototype task was examined to assess its (a). relation to the ABLA hierarchy, (b). predictive validity, and (c). test-retest reliability. Results from 23 participants with developmental disabilities suggest that visual-visual nonidentity matching is a worthwhile addition to the ABLA test and is positioned in the ABLA hierarchy above Level 4 (visual-visual identity matching) and below Level 6 (auditory-visual discrimination). The prototype visual-visual nonidentity matching task also demonstrated high predictive validity and test-retest reliability.

Analysis of proctor marking accuracy in a computer-aided personalized system of instruction course.

In a computer-aided version of Keller's personalized system of instruction (CAPSI), students within a course were assigned by a computer to be proctors for tests. Archived data from a CAPSI-taught behavior modification course were analyzed to assess proctor accuracy in marking answers as correct or incorrect. Overall accuracy was increased by having each test marked independently by two proctors, and was higher on incorrect answers when the degree of incorrectness was larger.

Feedback and its effectiveness in a computer-aided personalized system of instruction course.

In a computer-managed version of Keller's personalized system of instruction, students received frequent feedback from more advanced students within the course. Overall accuracy of student-provided feedback was 87%, and students complied with 61% of the feedback.

Predicting the relative efficacy of three presentation methods for assessing preferences of persons with developmental disabilities.

Choices were presented to 9 individuals with developmental disabilities using a two-choice format. Each pair of items, selected based on prior preference assessment, was presented to each participant in three conditions (actual items, pictures of the items, and spoken-name presentation) using a reversal design. The evaluation was conducted using food items, and was then repeated using nonfood items. The participants were also given a test to measure their skills on discrimination tasks ranging in difficulty from simple to conditional discriminations. The participants' abilities to make consistent choices with food and nonfood items were predicted, with 94% accuracy, by their discrimination skills. The findings suggest that presentation methods can affect the accuracy of a choice assessment, and that the systematic assessment of basic discrimination skills can be used to predict the effectiveness of different presentation methods in this population.

Choice, Degree of Preference, and Happiness Indices with Persons with Intellectual Disabilities: A Surprising Finding.

Two persons with severe intellectual disabilities and two persons with profound intellectual disabilities were repeatedly presented with five different pairs of food items. The five pairs of items represented different degrees of preference, from highest to lowest. Happiness indices were monitored from the time that a pair of items was presented until a choice was made. Surprisingly, participants showed very few happiness indices throughout the study, and degree of preference had very little effect on frequency of happiness indices. Questions are raised regarding choice opportunities and indices of happiness as indicators of quality of life.

Studies using single-subject designs in sport psychology: 30 years of research.

A prominent feature of behavior-analytic research has been the use of single-subject designs. We examined sport psychology journals and behavioral journals published during the past 30 years, and located 40 studies using single-subject designs to assess interventions for enhancing the performance of athletes and coaches. In this paper, we summarize that body of research, discuss its strengths and limitations, and identify areas for future research.

Teaching children with autism spectrum disorder to mand for information using "which?".

We examined a procedure consisting of a preference assessment, prompting, contrived conditioned establishing operations, and consequences for correct and incorrect responses for teaching children with autism to mand "which?" We used a modified multiple baseline design across 3 participants. All the children learned to mand "which?" Generalization occurred to the natural environment, to a novel activity, and to a novel container; the results were maintained over time.

On the relation between reinforcer efficacy and preference.

Most research on stimulus preference and reinforcer assessment involves a preference assessment that is followed by a reinforcer assessment. Typically, the most and least preferred stimuli are tested as reinforcers. In the current study, we first quantified the reinforcing efficacies of six food items and then assessed relative preference for each item. Relative preference ranking and reinforcer efficacies showed almost perfect concordance for 1 participant and partial concordance for the other. Discordance tended to occur with the weakest reinforcers.

Evaluation of a self-instructional manual for conducting discrete-trials teaching with children with autism.

Discrete-trials teaching (DTT) is commonly used to implement applied behavior analysis treatment for children with autism. The authors investigated a revised self-instructional manual for teaching university students to implement a 21-component DTT procedure to teach three tasks to confederates role-playing children with autism. Also, as a motivational contingency, for each DTT session in which a student scored at or above 90% accuracy, they received US$10. After an average of 4.5 hr to master the training manual, students' average DTT performance improved from 52% in baseline to 88% while teaching a confederate. Students averaged 77% DTT performance during subsequent generalization sessions with a child with autism.

Teaching Object-Picture Matching to Improve Concordance between Object and Picture Preferences for Individuals with Developmental Disabilities: Pilot Study.

We evaluated teaching object-picture matching to improve concordance between preference assessments using objects and pictures of the same objects. Three participants with developmental disabilities who showed high and low preferences during assessments with objects but not with pictures were taught object-picture matching tasks unrelated to the items used during preference assessments. Training was evaluated in a modified multiple-baseline design and preference assessments with objects and pictures were repeated after training each object-picture matching task. Two participants showed improved concordance after mastering two and three training tasks, respectively. The third participant did not show concordance between object and picture preference assessments after mastering two tasks and after additional training. Our findings suggested that object-picture matching might be a prerequisite for picture preference assessments.

The assessment of basic learning abilities test for predicting learning of persons with intellectual disabilities: a review.

The Assessment of Basic Learning Abilities (ABLA) Test uses standard prompting and reinforcement procedures to assess the ease or difficulty with which a testee is able to learn a simple imitation and five two-choice discriminations. The authors review studies that have examined performance of participants with developmental disabilities (DD) on the ABLA test to predict (a) performance on a variety of simple imitations and two-choice discriminations, (b) performance on three-choice and four-choice discriminations, (c) the relative efficacy of three presentation modes (objects vs. photographs vs. verbal descriptions) for assessing preferences, (d) compliance of adults with DD and children with and without DD, and (e) participants' ability to learn to respond to the spoken names of pictures of common objects. Across all five types of studies, the predictive validity of the ABLA test has been very high.

Does ABLA Test Performance on the ABLA Test Predict Picture Receptive Name Recognition with Persons with Severe Developmental Disabilities.

Research has shown that performance on the Assessment of Basic Learning Abilities (ABLA) test correlates with language assessments for persons with developmental disabilities. This study investigated whether performance on ABLA Level 6, an auditory-visual discrimination, predicts performance on a receptive language task with persons with severe developmental disabilities. Five participants who passed ABLA Level 6, and five who failed ABLA Level 6, were each tested on five 2-choice discriminations that required them to point to pictures of common objects after hearing their names. Four of the five participants who had failed ABLA Level 6 failed all of the receptive name recognition tasks. All five participants who had passed ABLA Level 6 passed all of the name recognition tasks. The practical implications of these results are discussed.