Shape-constrained deformable brain segmentation: Methods and quantitative validation.

MRI-guided neuro interventions require rapid, accurate, and reproducible segmentation of anatomical brain structures for identification of targets during surgical procedures and post-surgical evaluation of intervention efficiency. Segmentation algorithms must be validated and cleared for clinical use. This work introduces a methodology for shape-constrained deformable brain segmentation, describes the quantitative validation used for its clinical clearance, and presents a comparison with manual expert segmentation and FreeSurfer, an open source software for neuroimaging data analysis. ClearPoint Maestro is software for fully-automatic brain segmentation from T1-weighted MRI that combines a shape-constrained deformable brain model with voxel-wise tissue segmentation within the cerebral hemispheres and the cerebellum. The performance of the segmentation was validated in terms of accuracy and reproducibility. Segmentation accuracy was evaluated with respect to training data and independently traced ground truth. Segmentation reproducibility was quantified and compared with manual expert segmentation and FreeSurfer. Quantitative reproducibility analysis indicates superior performance compared to both manual expert segmentation and FreeSurfer. The shape-constrained methodology results in accurate and highly reproducible segmentation. Inherent point based-correspondence provides consistent target identification ideal for MRI-guided neuro interventions.

Pre-clinical delivery of gene therapy products to the cerebrospinal fluid: challenges and considerations for clinical translation.

While the majority of gene therapy studies in neurological indications have focused on direct gene transfer to the central nervous system (CNS), there is growing interest in the delivery of therapeutics using the cerebrospinal fluid (CSF) as a conduit. Historically, direct CNS routes-of-administration (RoAs) have relied on tissue dynamics, displacement of interstitial fluid, and regional specificity to achieve focal delivery into regions of interest, such as the brain. While intraparenchymal delivery minimizes peripheral organ exposure, one perceived drawback is the relative invasiveness of this approach to drug delivery. In this mini review, we examine the CSF as an alternative RoA to target CNS tissue and discuss considerations associated with the safety of performing such procedures, biodistribution of therapeutics following single administration, and translation of findings given differences between small and large animals. These factors will help delineate key considerations for translating data obtained from animal studies into clinical settings that may be useful in the treatment of neurological conditions.

Post-laryngectomy pulmonary and related symptom changes following adoption of an optimal day-and-night heat and moisture exchanger (HME) regimen.

BACKGROUND: This study examined post-laryngectomy pulmonary and related symptom changes following establishment of an optimal day/night regimen (all day/night wear of devices with improved humidification) using a new generation range of heat and moisture exchanger (HME) devices. METHODS: In Phase 1 (6 weeks), 42 post-laryngectomy HME users transitioned from their usual HME regime to equivalent new device/s (i.e., "like-for-like"). In Phase 2 (6 weeks) participants used the full range of HMEs to achieve an optimal day/night regimen. Pulmonary symptoms, device use, sleep, skin integrity, quality of life and satisfaction were examined at baseline, and weeks 2 and 6 of each Phase. RESULTS: From baseline to end of Phase 2, cough symptoms and impact significantly improved, as did sputum symptoms, sputum impact, duration and types of HMEs used, reasons for HME replacement, involuntary coughs, and sleep. CONCLUSION: The new HME range supported improved HME use, with pulmonary and related symptom benefits.

Factors contributing to clinician training and development in the clinical area of laryngectomy and tracheoesophageal voice.

BACKGROUND: It has long been recognized that tracheoesophageal speech (TES) rehabilitation after laryngectomy is a specialized area of practice for speech and language therapist (SLTs) due to the complex nature of patient presentation and the invasive components of the SLT's role in this area. Therefore, postgraduate experience and training is required to work competently and safely in this clinical area. However, it is generally acknowledged that the steps and processes followed by individual clinicians to achieve this training and clinical skill development are inconsistent and vary widely across services. There is a need to identify critical elements deemed most beneficial to clinical skill development in order to inform future training models. AIMS: To explore clinicians' perceptions of factors that contribute to training and clinical skills development in the area of TES rehabilitation post-laryngectomy. METHODS & PROCEDURES: All participants were SLTs working in an Australian clinical service, with a current or recent clinical caseload that included patients using TES. A total of 36 SLTs were recruited and then grouped by level of experience (novice n = 15, intermediate n = 7, experienced n = 14). Each participant took part in one small focus group with other participants of similar experience level. Ten focus groups were conducted, each of approximately 60 min in duration. A semi-structured interview guide was used to facilitate the discussion of issues relating to training in this area. Thematic analysis was used to analyse transcripts and identify themes. OUTCOMES & RESULTS: Interviews identified six key themes, including: Learning with and from others; Formal programmes; Hands-on learning; Processes that influence training; and Individual influences. SLTs reported both positive issues and elements that were challenging across all five themes. The final (sixth) theme was identified regarding clinician perceptions of how this area differed to specialized training in other areas of the profession. The majority of themes were discussed equally by clinicians across all three experience levels. CONCLUSIONS & IMPLICATIONS: Participants across all experience levels identified that multiple factors contributed to clinicians successfully gaining skills, understanding and competency when working in TES rehabilitation post-laryngectomy. These factors, when fully considered and incorporated into future SLTs training pathways and opportunities, have the potential to optimize competency, skill acquisition and maintenance in this area. What this paper adds What is already known on this subject While studies have considered the training, preparation and knowledge base of SLTs working in the clinical area of TES, the focus has predominantly been at the immediate postgraduate level or assessment of university course work. No studies have used a qualitative methodology to consider the reflections and perceptions of clinicians' training pathways and training needs across all levels of experience for this clinical area. What this paper adds to existing knowledge The results of this study build upon the existing body of literature regarding education and training in this area, determining factors SLTs feel are required to successfully gain skills, understanding and competency when working in TES rehabilitation. The findings highlight that training pathways and methods in this clinical area are an ongoing consideration for SLTs regardless of experience level and have the ability to impact on future competency programmes, training opportunities and delivery methods in this area. What are the potential or actual clinical implications of this work? Effective and ongoing postgraduate training programmes and professional development opportunities have the potential to positively impact on professional competence and confidence, patient safety and overall service delivery. Hence, the themes generated from this research highlight essential factors to include within training and professional development programmes for SLTs in TES rehabilitation. This information can be used to help optimize current training pathways for all experience levels.

Speech and language therapists' reflections on developing and maintaining confidence in tracheoesophageal speech rehabilitation.

BACKGROUND: The management of tracheoesophageal speech (TES) rehabilitation is an area of speech and language therapists' (SLTs) clinical practice where knowledge and skills are primarily developed through postgraduate workplace experience and training. Although recent research suggests clinicians in Australia perceive there is adequate access to workplace training, little is known about how clinicians develop and/or maintain clinical confidence when working in this specialist caseload. AIMS: To investigate factors that contribute to development of clinician confidence as well as the factors that impact on improving and maintaining confidence when working in the clinical area of TES rehabilitation. METHODS & PROCEDURES: SLTs working in an Australian clinical service and in a current or recent caseload including patients using TES were eligible to participate. A total of 36 SLTs were recruited and then grouped by level of experience (novice n = 15, intermediate n = 7, experienced n = 14). Ten focus groups of 60-min duration were conducted each with three to four participants from the same experience level. A semi-structured interview guide was used to facilitate the discussion of issues relating to training and confidence; however, only the content pertaining to clinical confidence is reported. Thematic analysis was used to analyse the transcripts. OUTCOMES & RESULTS: Four themes were identified as contributing to the development of confidence: training, exposure, accessing support and mentorship, and leadership opportunities. Three themes were identified as critical for improving or maintaining clinical confidence: ongoing management of a caseload, ongoing support and further learning. An additional overarching theme was the desire for SLTs to classify or quantify their level of confidence, typically using a numeric scale or in years of clinical experience. The impact of varying contexts and caseloads on confidence levels was highlighted by all participants, but particularly those in the novice focus groups. CONCLUSIONS & IMPLICATIONS: The findings highlight the fact that the acquisition and maintenance of confidence is an ongoing consideration for SLTs, both those starting out and those with years of clinical experience. With patient presentation increasing in complexity, the importance of understanding contributing factors for gaining and maintaining confidence should be considered alongside postgraduate training and the provision of ongoing support for SLTs working in this specialized clinical area, regardless of experience level.

Factors influencing clinical consistency and variability in voice prosthesis management.

PURPOSE: Anecdotally it is recognised that management of tracheoesophageal speech (TES) post-laryngectomy varies between speech language pathology (SLP) services and clinicians. This study reviewed patterns of practice for TES management to examine patterns of practice and explore factors influencing variability. METHOD: A national survey was completed by SLP's from clinical services which manage TES. This online survey examined demographic and caseload information, initial voice prosthesis (VP) placement and procedures, VP cleaning and care recommendations, humidification management, equipment and service provision, and service delivery options at each site. RESULT: Lead clinicians from 34 sites (85% response rate) responded. Most clinical practice regarding initial VP insertion and management, as well as the timing and delivery of voice rehabilitation was highly consistent. Patient use of antifungal medications, TES and associated equipment provision, humidification management immediately post-surgery and some aspects of initial VP insertion were variable between services. The nature of the clinical setting, equipment funding and level of research evidence influenced variability in practice. CONCLUSION: Variability exists in a number of aspects of practice across Australian services offering TES management. Sources of variability need to be addressed nationally to ensure there is consistent, quality care available for all patients.

What Can We Do to Optimize Colonoscopy and How Effective Can We Be?

In the USA, colorectal cancer is the third most common cancer and third leading cause of cancer death among both men and women. Declining rates of colon cancer in the past decade have been attributed in part to screening and removal of precancerous polyps via colonoscopy. Recent emphasis has been placed on measures to increase the quality and effectiveness of colonoscopy. These have been divided into pre-procedure quality metrics (bowel preparation), procedural quality metrics (cecal intubation, withdrawal time, and adenoma detection rate), post-procedure metrics (surveillance interval), and other quality metrics (patient satisfaction and willingness to repeat the procedure). The purpose of this article is to review the data and controversies surrounding each of these and identify ways to optimize the performance of colonoscopy.

Can human mannequin-based simulation provide a feasible and clinically acceptable method for training tracheostomy management skills for speech-language pathologists?

PURPOSE: Workplace training for tracheostomy management is currently recognized to be inconsistent and insufficient. A novel approach, using technology-enhanced simulation, may provide a solution to training tracheostomy management skills by providing a consistent, time-efficient, and risk-free learning environment. The current research evaluated clinicians' tracheostomy skills acquisition after training in a simulated learning environment and explored changes in clinicians' confidence and perceptions after the experience. METHOD: Forty-two clinicians with no or low levels of tracheostomy skill attended one of six, 1-day simulation courses. The training involved both part-task skill learning and immersive simulated scenarios. To evaluate clinicians' acquisition of manual skills, performance of core tasks during the scenarios was assessed by independent observers. Questionnaires were used to examine perceived outcomes, benefits, and perceptions of the learning environment at pre-, post-, and 4 months post-training. RESULTS: Only 1 clinician failed to successfully execute all core practical tasks. Clinicians' confidence increased significantly ( p < .05) from pre- to post-workshop and was maintained to 4 months post-workshop across most parameters. All clinicians reported positive perceptions regarding their learning outcomes and learning in a simulated environment. CONCLUSION: These findings validate the use of simulation as a clinical training medium and support its future use in tracheostomy competency-training pathways.

Device life of the Provox Vega voice prosthesis.

Device life of the Provox Vega Indwelling voice prosthesis is as yet untested outside Europe. The current study examined device life and reasons for replacement within an Australian clinical setting. Twenty-three participants were monitored for device life and reasons for replacement. Main outcome measure was days to failure of initial device. Average device life and reasons for replacement were secondary measures. Initial device life data revealed 67 % had functioning devices at 3 months, 52 % at 6 months and 29 % at 12 months. Average device life was 207 days (median of 222). The majority of devices (97 %) failed due to leakage through the prosthesis. The Provox Vega Indwelling voice prosthesis had favourable device life in this cohort of patients and in comparison to European data. Reasons for replacement were consistent with international literature.

A prospective, randomized comparative study of patient perceptions and preferences of two types of indwelling voice prostheses.

BACKGROUND: Technical and device life issues are frequently the focus of post-laryngectomy rehabilitation studies examining indwelling voice prostheses. Patient perceptions and preferences are considered less often. AIMS: To determine patient perceptions of two indwelling voice prostheses across parameters relating to device use and maintenance and to determine what factors contribute to patient preferences. METHODS & PROCEDURES: In a randomized, cross-over study, 31 laryngectomy patients completed a 3-week trial of both the new indwelling Provox Vega and a comparator device, the Blom-Singer Classic Indwelling. Patient perceptions of the insertion process, cleaning and care, and voicing were explored after each trial. At the end, overall preference and factors influencing device preference were examined. OUTCOME & RESULTS: At the conclusion of the crossover trial, a significantly higher proportion of patients felt voice effort, overall voicing, bloating, and ease and effectiveness of cleaning were superior for the Provox Vega. No preference was noted for insertion processes. Overall device preference was influenced by improved voicing followed by cleaning and care. CONCLUSIONS & IMPLICATIONS: Patients do not perceive all indwelling devices as equal and should have the opportunity to trial different devices to find the best device for their needs.

Perceptual characteristics of tracheoesophageal speech production using the new indwelling Provox Vega voice prosthesis: a randomized controlled crossover trial.

BACKGROUND: The objective of this study was to determine if the design enhancements incorporated into the new Provox Vega Indwelling Voice prostheses result in any positive benefits in vivo. METHODS: Using a randomized, crossover study design, 31 participants using tracheoesophageal speech postlaryngectomy completed a 3-week trial of the Provox Vega and a comparator device. Main outcome measures included patient perceptions of vocal effort and quality using each device, and perceptual judgments of voice quality produced. RESULTS: The majority of patients (72%) indicated the Provox Vega gave them overall better voice quality and 52% felt they required less effort to phonate. Voice samples produced with the Provox Vega were also perceived by listeners to be significantly (p < .05) less strained, easier to understand, produced with less effort, and the better speech sample overall. CONCLUSION: Results support that the aerodynamic improvements incorporated in the design of the new Provox Vega facilitate enhanced voice and speech qualities.

First clinical experience with a new non-indwelling voice prosthesis (Provox NID) for voice rehabilitation after total laryngectomy.

CONCLUSION: The new Provox NID non-indwelling voice prosthesis investigated in this study provides a good option for laryngectomized patients using non-indwelling voice prostheses and can potentially improve safety and increase patients' satisfaction with their voice and speech. OBJECTIVE: To investigate the feasibility of and patient satisfaction with the Provox NID non-indwelling voice prosthesis. MATERIAL AND METHODS: Pre- and post-study questionnaires were used to evaluate the patients' former voice prosthesis and the Provox NID voice prosthesis. In addition, measurements of pull-out force, maximum phonation time and loudness were made for both voice prostheses. In vitro measurements of airflow characteristics were also made. Following a 6-week trial, all patients provided feedback on the new voice prosthesis and the results were used to further improve the Provox NID. This final version of the new voice prosthesis was subsequently trialled and evaluated by 10 patients 6 months later. RESULTS: Overall results showed that patient satisfaction with the Provox NID non-indwelling voice prosthesis was favourable. The pull-out force for the new prosthesis was significantly higher than that for the formerly used prosthesis and its aerodynamic characteristics were better.