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Parenteral and enteral nutrition support are key components of care for various medical and physiological conditions in infants, children, and adults. Nutrition support practices have advanced over time, driven by the goals of safe and sufficient delivery of needed nutrients and improved patient outcomes. These advances have been, and continue to be, dependent on research and development studies. Such studies address aspects of enteral and parenteral nutrition support: formulations, delivery devices, health outcomes, cost‐effectiveness, and related metabolism. The studies are supported by public funding from the government and by private funding from foundations and from the nutrition support industry. To build public trust in nutrition support research findings, it is important to underscore ethical research conduct and reporting of results for all studies, including those with industry sponsors. In 2019, American Society for Parenteral and Enteral Nutrition's (ASPEN's) Board of Directors established a task force to ensure integrity in nutrition support research that is done as collaborative partnerships between the public (government and individuals) and private groups (foundations, academia, and industry). In this ASPEN Position Paper, the Task Force presents principles of ethical research to guide administrators, researchers, and funders. The Task Force identifies ways to curtail bias and to minimize actual or perceived conflict of interests, as related to funding sources and research conduct. Notably, this paper includes a Position Statement to describe the Task Force's guidance on Public‐Private Partnerships for research and funding. This paper has been approved by the ASPEN Board of Directors. [ABSTRACT FROM AUTHOR]

Nurse‐led clinics are known to positively impact and benefit patients; however, there is little understanding of the role of the nurse in a nurse‐led male Lower Urinary Tract Symptoms (LUTS) clinic. LUTS affect up to 30% of males over 65 in the United Kingdom and can significantly impact the quality of life of the person experiencing them. LUTS can be managed with conservative changes, as well as with medication and surgical intervention. The aim of this scoping review is to map what is known about the role of the nurse in a nurse‐led male LUTS clinic and what research tells us regarding, the barriers and enablers in nurses leading a male LUTS clinic. This scoping review follows the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses extension for Scoping Reviews (PRISMA‐SCR) checklist and the methodological guidelines set out by the Joanna Briggs institute. A literature search was carried out over three databases (CINAHL, Medline Ovid, ProQuest health and medical collection) and systematically searched from 2000 to 2021. Grey literature was also searched, and citation chaining was undertaken. Following a systematic review of the literature, four papers met the inclusion criteria for this scoping review. The emergent themes across the four papers consisted of structure, assessment and resources, and effectiveness of the nurse‐led male LUTS clinic. There was clear agreement across the literature regarding the investigations and assessment the nurse should carry out. Ongoing practical, theoretical, and observational training and education is required to ensure the nurse is competent in running a male LUTS clinic. The papers reviewed showed the nurse provided a supportive role to the consultant. However, there is evidence indicating there is a move towards autonomous practice. There is a dearth of the current research relating to the role of the nurse in nurse‐led male LUTS clinics and the enablers and barriers in nurses leading male LUTS clinics. Further research should be considered to gain a better understanding of where nurse‐led male LUTS clinics currently take place, what the role of the nurse is in leading a LUTS clinic and what enablers and barriers exist. [ABSTRACT FROM AUTHOR]

Background: Robotic surgery has gained widespread acceptance in elective interventions, yet its role in emergency procedures remains underexplored. While the 2021 WSES position paper discussed limited studies on the application of robotics in emergency general surgery, it recommended strict patient selection, adequate training, and improved platform accessibility. This prospective study aims to define the role of robotic surgery in emergency settings, evaluating intraoperative and postoperative outcomes and assessing its feasibility and safety. Methods: The ROEM study is an observational, prospective, multicentre, international analysis of clinically stable adult patients undergoing robotic surgery for emergency treatment of acute pathologies including diverticulitis, cholecystitis, and obstructed hernias. Data collection includes patient demographics and intervention details. Furthermore, data relating to the operating theatre team and the surgical instruments used will be collected in order to conduct a cost analysis. The study plans to enrol at least 500 patients from 50 participating centres, with each centre having a local lead and collaborators. All data will be collected and stored online through a secure server running the Research Electronic Data Capture (REDCap) web application. Ethical considerations and data governance will be paramount, requiring local ethical committee approvals from participating centres. Discussion: Current literature and expert consensus suggest the feasibility of robotic surgery in emergencies with proper support. However, challenges include staff training, scheduling conflicts with elective surgeries, and increased costs. The ROEM study seeks to contribute valuable data on the safety, feasibility, and cost-effectiveness of robotic surgery in emergency settings, focusing on specific pathologies. Previous studies on cholecystitis, abdominal hernias, and diverticulitis provide insights into the benefits and challenges of robotic approaches. It is necessary to identify patient populations that benefit most from robotic emergency surgery to optimize outcomes and justify costs. [ABSTRACT FROM AUTHOR]

The article discusses the approaches for gluteal tendinopathy which includes education plus exercise and corticosteroid injection.

Background: Weight loss interventions have not been advocated for overweight/obese older adults due to potential loss of skeletal muscle and strength impacting on physical function with potential loss of independence. Carotenoids and polyphenols are inversely associated with sarcopenic symptomology. This paper reports the protocol of a study evaluating the efficacy of a high-protein, energy restricted diet rich in carotenoids and polyphenols on body composition, muscle strength, physical performance and quality of life in overweight and obese older adults.Methods: This randomised controlled clinical trial will recruit community-dwelling, healthy overweight and obese older adults (≥60 years) for a 12-week weight loss intervention. Seventy-three participants will be recruited and randomized to an energy restricted (~30% restriction), isocaloric diet (30% protein; 30% carbohydrate; 40% fat) enriched with either: a) 375 g/d of high carotenoid vegetables, 300 g/d high carotenoid fruit, and 40-60 ml extra-virgin olive oil (EVOO); or b) 375 g/d of lower carotenoid vegetables, 300 g/d lower carotenoid fruit, and 40-60 ml Polyunsaturated fatty acid (PUFA) based oil. All participants will receive individual dietary counselling each fortnight for the duration of the study and will be asked to maintain their habitual level of physical activity throughout the study. The primary outcome will be appendicular skeletal muscle (ASM) assessed by dual energy X-ray absorptiometry (DXA). Secondary outcomes will include body weight, fat-free mass (FFM), fat mass (FM), muscle strength (Isometric hand-grip strength), physical performance (Short Physical Performance Battery), physical activity (International Physical Activity Questionnaire) and health related quality of life (SF-36). Outcomes will be measured at baseline and at week 12.Discussion: The results of this study will provide a novel insight relating to the potential influence of high carotenoid and polyphenol intakes on attenuation of ASM during dietary energy-restricted weight loss in overweight and obese older adults.Trial Registration: The trial was registered on the Australia New Zealand Clinical Trials Register ( ACTRN12616001400459 ); Trial registration date: 10th October, 2016. [ABSTRACT FROM AUTHOR]

Background: While hearing aids for a contralateral routing of signals (CROS-HA) and bone conduction devices have been the traditional treatment for single-sided deafness (SSD) and asymmetric hearing loss (AHL), in recent years, cochlear implants (CIs) have increasingly become a viable treatment choice, particularly in countries where regulatory approval and reimbursement schemes are in place. Part of the reason for this shift is that the CI is the only device capable of restoring bilateral input to the auditory system and hence of possibly reinstating binaural hearing. Although several studies have independently shown that the CI is a safe and effective treatment for SSD and AHL, clinical outcome measures in those studies and across CI centers vary greatly. Only with a consistent use of defined and agreed-upon outcome measures across centers can high-level evidence be generated to assess the safety and efficacy of CIs and alternative treatments in recipients with SSD and AHL.Methods: This paper presents a comparative study design and minimum outcome measures for the assessment of current treatment options in patients with SSD/AHL. The protocol was developed, discussed, and eventually agreed upon by expert panels that convened at the 2015 APSCI conference in Beijing, China, and at the CI 2016 conference in Toronto, Canada.Results: A longitudinal study design comparing CROS-HA, BCD, and CI treatments is proposed. The recommended outcome measures include (1) speech in noise testing, using the same set of 3 spatial configurations to compare binaural benefits such as summation, squelch, and head shadow across devices; (2) localization testing, using stimuli that rove in both level and spectral content; (3) questionnaires to collect quality of life measures and the frequency of device use; and (4) questionnaires for assessing the impact of tinnitus before and after treatment, if applicable.Conclusion: A protocol for the assessment of treatment options and outcomes in recipients with SSD and AHL is presented. The proposed set of minimum outcome measures aims at harmonizing assessment methods across centers and thus at generating a growing body of high-level evidence for those treatment options. [ABSTRACT FROM AUTHOR]

Objectives: A prospective parallel cohort trial was conducted to compare outcomes of patients treated with maxillary protraction vs LeFort 1 maxillary advancement surgery.Setting and Sample Population: The primary site for the clinical trial is Children's Hospital Los Angeles; the satellite test site is Seattle Children's Hospital. All patients have isolated cleft lip and palate and a skeletal Class III malocclusion.Material and Methods: A total of 50 patients, ages 11-14, will be recruited for the maxillary protraction cohort. The maxillary surgery cohort consists of 50 patients, ages 16-21, who will undergo LeFort 1 maxillary advancement surgery. Patients with additional medical or cognitive handicaps were excluded from the study.Results: Current recruitment of patients is on track to complete the study within the proposed recruitment period.Conclusion: This observational trial is collecting information that will examine dental, skeletal, financial and quality-of-life issues from both research cohorts. [ABSTRACT FROM AUTHOR]

Background: Early language delay is exacerbated by social disadvantage. Factors such as parents' low levels of literacy, confidence and self‐perception can affect the capacity to act on advice received, critical to empowerment. Methods used to achieve successful health outcomes in socially disadvantaged clinical populations may need enhancing. Aims: To compare the impact of standard parent‐based intervention (PBI) to enhanced PBI for young children with speech, language and communication needs (SCLN) and their families living in more socially disadvantaged populations. Methods and Procedures: A multicentre clustered blind randomised controlled trial was used to compare the effect of parent‐based group interventions to improve early language development with children (mean age 27.5 months) from more socially disadvantaged populations with an expressive vocabulary of 40 or less single words. Intervention sessions were delivered by a speech and language therapist, over a 20‐week period. Participants received one of two interventions: (1) Standard Care – indirect group PBI – (PBI) (2) Enhanced Care: indirect group enhanced PBI – (EPBI). Both standardised and non‐standardised measures were used as outcomes. Parent engagement in the intervention was captured through analysis of attendance and the Parent Activation Measure – Speech & Language Therapy (PAM‐SLT) (Insignia Health, 2014). The PAM measures a person's knowledge, skills and confidence to manage their own health and well‐being (NHS England, 2018). In this study, activation referred to parents' knowledge, skills and confidence to manage their child's language development. Outcomes and Results: One hundred fifty‐five participants were randomised at baseline. Children in both groups made significant improvements in the outcome on MacArthur‐Bates Communicative Development Inventories Sentence Length, from pre‐intervention to post‐intervention and 6 months post‐intervention (p < 0.05). Changes in vocabulary and expressive language skills were more equivocal, showing wide variation in confidence intervals for both groups. Where parents attended at least one intervention session almost all effect sizes were in favour of the EPBI intervention. Parents' activation levels significantly increased for both groups (EPBI p < 0.001, PBI p = 0.003), with a moderate effect size in favour of EPBI (Hedges' G 0.37, confidence interval –0.02 to 0.76), although wide variation was found. Conclusions and Implications: This trial provides some evidence of facilitating the language development of children with SLCN from more socially disadvantaged areas through supporting caregivers. However, we found variation in outcomes; some children made excellent progress, whilst others did not. Further exploration of parent engagement and its relationship to child language outcomes will be valuable to understanding more about mechanisms of change in interventions that involve parents. WHAT THIS PAPER ADDS: What is already known on the subject: Speech, language and communication needs (SLCN) have a knock‐on effect on emotional well‐being, school readiness, literacy and school attainment, putting children at increased risk of long‐term consequences such as poor literacy, mental health problems and unemployment. In disadvantaged areas, the prevalence of language difficulties is higher than elsewhere. Factors such as parents' low levels of literacy, confidence and self‐perception can affect the capacity to act on advice received, critical to empowerment. What this paper adds to existing knowledge: Children with SLCN from more socially disadvantaged areas can make improvements in their language development through parent intervention, although wide individual variation was found. There was some evidence that children achieve better outcomes with EPBI, which employed an interagency collaborative approach. Parent's engagement (activation levels) increased significantly over time with intervention, with the increase twice as big for EPBI. What are the potential or actual clinical implications of this work?: This trial provides some evidence that it is possible to facilitate the language development of children from more socially disadvantaged areas through supporting their caregivers. Further research would be useful to determine whether increases in parent engagement are related to adherence to intervention and change in child outcomes. [ABSTRACT FROM AUTHOR]

This study aims to review controlled studies on the effectiveness of primary-school-based art therapy to assess quality, synthesise findings and make informed suggestions for future research. A systematic review was undertaken using database/hand searches, PICOS inclusion/exclusion criteria and the Downs and Black Checklist for Measuring Study Quality. A descriptive synthesis was used to present findings. Out of 201 found, only four papers met the inclusion criteria. Art therapy was reported as having a significant positive impact on some outcomes (classroom behaviour; Oppositional Defiant Disorder; Separation Anxiety Disorder) and non-significant greater gains towards Locus of Control. One paper reported no significant impact on outcomes but maintained scores for self-concept compared to a significant decrease for no intervention. Quality of studies was assessed to be between the 3rd and 5th quintile of possible scores on the Downs and Black Checklist. The studies provided important evidence of some positive effects and no negative effects. Benefits were reported for children struggling with classroom behaviour, Oppositional Defiant Disorder, Separation Anxiety Disorder, Locus of Control and self-concept. The lack of harm reported is also an important finding. However, to evidence clinical effectiveness, there is an urgent need for further robust research. [ABSTRACT FROM PUBLISHER]

Introduction:  The use of interventional radiology (IR) in the treatment of pediatric solid tumors has markedly increased over the last three decades. However, data on effectiveness of IR-techniques, such as embolization/ablation, are scarce. In this systematic review and meta-analysis, we examined the outcomes of IR-procedures in the treatment of solid tumors in children.Materials and Methods:  Using a defined search strategy, we searched for studies reporting the use of IR-techniques for pediatric solid tumors from 1980 to 2017. Reports with less than three patients, review, and opinion articles were excluded. The study was conducted under preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. We analyzed dichotomous and continuous variables by appropriate statistical methods.Results:  Of 567 articles screened, 21 papers met the inclusion criteria (12 retrospective, 7 prospective, and 2 randomized-control trials). Many of the analyzed papers described relatively small cohorts of patients. IR-guided procedures were mainly rescue procedures to treat primarily unresectable tumors, local recurrences, or metastases. Inclusion/exclusion criteria and success definition were not specified in most reports. Major side effects were documented in 17/286 (6%) infants, while minor side effects were self-limiting in most patients. Six studies had a comparison between tumor embolization (127 infants) to surgery or chemotherapy without IR-procedures (113 controls). The meta-analysis showed lower mortality (16 vs. 47%) and surgical time for resection (206 vs. 250 m), higher 2-year tumor-free survival (82 vs. 36%), and favorable histology in IR group (p < 0.001 for all).Conclusion:  IR-guided techniques are promising in the treatment of pediatric solid tumors. Further prospective (randomized) trials are needed to clarify efficacy. [ABSTRACT FROM AUTHOR]

Background: Kidney disease is a progressive, debilitating condition. Patients experience challenging physical and psychological symptoms and are at increased risk of anxiety, depression, and poor mental wellbeing. Access to specialist psychological or social support is limited, with inadequate provision of psychosocial support available across UK renal units. The COSMIC study (examining the acceptability and feasibility of the Compassionate Mindful Resilience programme for adult patients with chronic kidney disease) aimed to support a new service development project, in partnership with Kidney Care UK, by implementing the Compassionate Mindful Resilience (CMR) programme, developed by MindfulnessUK, and explore its feasibility for patients with stage 4 or 5 kidney disease and kidney transplant recipients. This paper reports on the qualitative exploratory work which examined the experiences of study participants, their adherence to practice, and the acceptability of the intervention. Method: Participants (n = 19) took part in semi-structured interviews, which were transcribed, coded, and thematically analysed. Results: Three themes (and nine subthemes) were reported: experiences of the CMR programme that facilitated subjective benefit, participants' lived and shared experiences, and the practicalities of CMR programme participation. All participants reported that they found taking part in the CMR programme to be a beneficial experience. Conclusion: The CMR programme was found to be an acceptable intervention for people living with kidney disease and provided tools and techniques that support the mental health and wellbeing of this patient group. Further qualitative exploration into participant experience should be integrated within future trials of this intervention. [ABSTRACT FROM AUTHOR]

Background: Anxiety disorder is the most prevalent psychiatric disorder. Benzodiazepines, which are often used for anxiety in patients with anxiety disorder, have various side effects. Lavender, one of the most commonly used essential oils in aromatherapy, has the potential to reduce benzodiazepine use for anxiety disorders. Methods: This study is a multicenter, double-masked, randomized, placebo-controlled clinical trial. The study will recruit patients aged 20–59 years old with generalized anxiety disorder and panic disorder among anxiety disorders. The bottle containing the test solution (lavender aroma essential oil or distilled water) will be given to the patients. Patients will carry the bottles with them in their daily life and use the drops on tissue paper when anxious. The primary endpoint is the number of times anxiolytics used in 28 days. Discussion: If the use of benzodiazepines could be reduced by sniffing lavender aroma, which is inexpensive and safe, it would contribute not only to the risks associated with benzodiazepine use but also to the health care economy and could even be added as a standard treatment. Trial registration: University hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), ID: UMIN000034422 Registered 17 January 2019. [ABSTRACT FROM AUTHOR]

Background: The purpose of this paper is to provide a preliminary evaluation of treatment outcomes, retention and client satisfaction following a 12-week combined cognitive behavioural therapy (CBT) and motivational enhancement therapy (MET) group treatment for cannabis use disorder (CUD) delivered in an outpatient setting. Implementation of the program is also described. Methods: A retrospective observational cohort study was conducted using data collected from medical records and self-report assessments. Participants were treatment-seeking cannabis users at the Centre for Addiction and Mental Health, Toronto. Cannabis use, cannabis-related problems, craving, withdrawal symptoms, self-efficacy for remaining abstinent, depression and anxiety were assessed pre- and post-treatment. Treatment retention was calculated by inspecting clinic attendance records, and client satisfaction was evaluated using an anonymous feedback survey. Potential predictors of treatment outcomes and retention were investigated in exploratory analyses. Results: Cannabis use was lower and days of abstinence higher post-treatment (vs pre-treatment). Post-treatment improvements in cannabis-related problems, craving, withdrawal symptoms, self-efficacy and mood were also observed. Completion of group treatment (⩾75% of sessions attended) was 57% and moderate levels of treatment satisfaction were reported. Conclusions: This study provides preliminary evidence that a 12-week combined CBT and MET treatment for cannabis use disorder delivered in a novel group setting improves cannabis use outcomes. Potential predictors of reduced cannabis use and retention were identified. Future controlled studies are warranted, and strategies for increasing retention should be explored. [ABSTRACT FROM AUTHOR]

Simple Summary: Measurable residual disease monitoring is an important prognostic tool in haematological malignancies commonly performed by two modalities: flow cytometry and molecular methods. In this paper, we studied consecutive adult participants requiring flow cytometric measurable residual disease monitoring. This is one of the largest prospective Australian studies to date, providing a unique insight into the Australian context. We described five distinctive patterns associated with disease relapse and survival and also investigated correlation with molecular methods. Our results provide additional evidence that the correlation between molecular and flow cytometric methods is moderate in B-lymphoblastic leukaemia and poor in acute myeloid leukaemia. There was a strong association between flow cytometry results and relapse in acute myeloid leukaemia but less so for B-lymphoblastic leukaemia. Our novel data indicate that the pattern of change in measurable residual disease over time was associated with the risk of relapse, particularly in acute myeloid leukaemia and highlight the divergent ways measurable residual disease testing can be employed across different leukaemias. Measurable residual disease (MRD) detected by flow cytometry (FC) is well established in paediatric B- lymphoblastic leukaemia (B-ALL) and adult chronic lymphocytic leukaemia (CLL), but its utility in adult B-ALL and adult acute myeloid leukaemia (AML) is less clear. In this prospective MRD study, one of the largest in Australia to date, we examined consecutive bone marrow aspirates from adult participants with B-ALL (n = 47) and AML (n = 87) sent for FC-MRD testing at a quaternary referral hospital in Sydney. FC-MRD results were correlated to corresponding Mol-MRD testing where available and clinical outcomes at three-month intervals over 1 year. B-ALL showed a moderate positive correlation (rs = 0.401, p < 0.001), while there was no correlation between FC-MRD and Mol-MRD for AML (rs = 0.13, p = 0.237). Five FC-MRD patterns were identified which had significant associations with relapse (X2(4) = 31.17(4), p > 0.001) and survival (X2(4) = 13.67, p = 0.008) in AML, but not in B-ALL. The three-month MRD results were also strongly associated with survival in AML, while the association in B-ALL was less evident. There was a moderate correlation between FC-MRD and Mol-MRD in B-ALL but not AML. The association of FC-MRD with relapse and survival was stronger in AML than in B-ALL. Overall, these findings suggest divergent utilities of FC-MRD in AML and B-ALL. [ABSTRACT FROM AUTHOR]

The definition of Early Cholecystectomy (EC) is still debatable. This paper aims to find whether the timing of EC affects outcomes. The article reports a multicentric prospective observational study including patients with acute calculous cholecystitis (ACC) who had cholecystectomy within ten days from the onset of symptoms. Kruskall-Wallis test, Fisher's Exact test, and Spearman rank correlation were used for statistical analysis. The patients were divided into three groups depending on the timing of the operation: 0–3 days, 4–7 days, or 8–10 days from the onset of symptoms. 1117 patients were studied over a year. The time from the onset of symptoms to EC did not affect the post-operative complications and mortality, the conversion, and the reintervention rate. The time represented a significant risk factor for intraoperative complications (0–3 days, 2.8%; 4–7 days, 5.6%; 8–10 days, 7.9%; p = 0.01) and subtotal cholecystectomies (0–3 days, 2.7%; 4–7 days, 5.6%; 8–10 days, 10.9%; p < 0.001). ACC is an evolutive inflammatory process and, as the days go by, the local and systemic inflammation increases, making surgery more complex and difficult with a higher risk of intraoperative complications. We recommend performing EC for ACC as soon as possible, within the first ten days of the onset of symptoms. [ABSTRACT FROM AUTHOR]

Background: At the beginning of the 21st century, international adoptions of children with cleft lip and/or palate increased dramatically in Sweden. Many children arrived partially or totally unoperated, despite being at an age when palatoplasty has usually been performed. To date, the speech development of internationally adopted (IA) children has been described up to age 7–8 years, but later development remains unstudied. Aims: To investigate speech development between ages 5 and 10 years in children born with cleft lip and palate (CLP) adopted from China and to compare them with non‐adopted (NA) children with CLP. A secondary aim was to compare the frequencies of secondary palatal surgery and number of visits to a speech and language pathologist (SLP) between the groups. Methods & Procedures: In a longitudinal study, 23 IA children from China were included and matched with 23 NA children born in Sweden. Experienced SLPs blindly reassessed audio recordings from routine follow‐ups at ages 5 and 10 years. Velopharyngeal function (VPF) was assessed with the composite score for velopharyngeal competence (VPC‐Sum) for single words and rated on a three‐point scale (VPC‐Rate) in sentence repetition. Target sounds in words and sentences were phonetically transcribed. Per cent correct consonants (PCC) were calculated at word and sentence levels. For in‐depth analyses, articulation errors were divided into cleft speech characteristics (CSCs), developmental speech characteristics (DSCs) and s‐errors. Information on secondary palatal surgery and number of visits to an SLP was collected. Outcomes & Results: VPF differed significantly between the groups at both ages when assessed with VPC‐Sum, but not with VPC‐Rate. Regardless of the method for assessing VPF, a similar proportion in both groups had incompetent VPF but fewer IA than NA children had competent VPF at both ages. IA children had lower PCC at both ages at both word and sentence levels. More IA children had CSCs, DSCs and s‐errors at age 5 years, and CSCs and s‐errors at age 10. The development of PCC was significant in both groups between ages 5 and 10 years. The proportion of children receiving secondary palatal surgery did not differ significantly between the groups, nor did number of SLP visits. Conclusions & Implications: CSCs were more persistent in IA children than in NA children at age 10 years. Interventions should target both cleft and DSCs, be comprehensive and continue past the pre‐school years. WHAT THIS PAPER ADDS: What is already known on this subject: At the beginning of the 21st century, IA children with cleft lip and/or palate arrived in Sweden partially or totally unoperated, despite being at an age when palatoplasty has usually been performed. Studies up to age 7–8 years show that adopted children, compared with NA peers, have poorer articulation skills, demonstrate both cleft‐related and developmental articulation errors, and are more likely to have velopharyngeal incompetence. Several studies also report that adopted children more often require secondary palatal surgery due to fistulas, dehiscence or velopharyngeal incompetence compared with NA peers. What this paper adds to existing knowledge: This longitudinal study provides additional knowledge based on longer follow‐ups than previous studies. It shows that the proportion of children assessed to have incompetent VPF was similar among IA and NA children. It was no significant difference between the groups regarding the proportion that received secondary palatal surgery. However, fewer IA children were assessed to have a competent VPF. Developmental articulation errors have ceased in most IA and all NA children at age 10 years, but significantly more adopted children than NA children still have cleft‐related articulation errors. What are the potential or actual clinical implications of this work?: Speech and language therapy should target both cleft‐related and developmental articulation errors. When needed, treatment must be initiated early, comprehensive, and continued past the pre‐school years, not least for adopted children. [ABSTRACT FROM AUTHOR]

Objective: To determine possible changes in outcome from acute respiratory distress syndrome (ARDS) and to compare severity of lung injury and methods of treatment from 1967 to 1994.Data Sources: Computerized (Medline, Current Contents) and manual (Cumulated Index Medicus) literature search using the key word and/or title ARDS.Study Selection: Only clinical studies published as full papers reporting data on both patient mortality (survival) and oxygenation index (PaO2/FIO2) were included. Single case reports, abstracts, reviews and editorials were excluded from evaluation.Data Extraction: Relevant data were extracted in duplicate, followed by quality checks on approximately 80% of data extracted.Data Synthesis: 101 papers reporting on 3264 patients were included: 48 studies (2207 patients) were performed in the USA, 43 studies (742 patients) in Europe and 10 studies (315 patients) elsewhere. Mortality reported in these studies was 53 +/- 22% (mean +/- SD), with no apparent trend towards a higher survival (1994: 22 studies, mortality 51 +/- 19%). The mean PaO2/FIO2 ratio remained unchanged throughout the observation period (118 +/- 47 mmHg). No correlation could be established between outcome and PaO2/FIO2 or lung injury score. Patients who underwent pressure-limited ventilation had a significantly lower mortality (35 +/- 20%) than patients on volume-cycled ventilation (54 +/- 22%) or patients for whom there was no precise information on ventilatory support (59 +/- 19%). Significantly lower PaO2/FIO2 ratios (61 +/- 17 mmHg) were observed in patients prior to extracorporeal lung assist, together with mortality rates in the range of those for conventionally treated patients (55 +/- 22%).Conclusions: The mortality of ARDS patients remained constant throughout the period studied. Therefore, the standard for outcome in ARDS should be a mortality in the 50% range. Neither PaO2/FIO2 ratio nor lung injury score was a reliable predictor for outcome in ARDS. Patients might benefit from pressure-limited ventilatory support, as well as extracorporeal lung assist. Since crucial data were missing in most clinical studies, thus preventing direct comparison, we emphasize the importance of using standardized definitions and study entry criteria. [ABSTRACT FROM AUTHOR]

Purpose: Postmicturition dribbling (PMD) is a stressful symptom in middle-aged men characterized by urinary leakage after the completion of normal voiding. Appropriate treatments have not yet been introduced. This study assessed the efficacy of treatment of PMD with 75 mg udenafil daily.Materials and Methods: The study included 138 men with regular sexual lifestyles. The Hallym PMD questionnaire (HPMDQ) was used to assess PMD symptoms. After all basic examinations, patients were randomly assigned to either udenafil or placebo. Patients completed the surveys, uroflowmetry (UFM), a bladder scan, and the paper test during the follow-up visit.Results: The mean age of the patients was 57.6 years. PMD with one of every three urinations was experienced by 59 patients (42.8%), whereas 45 patients (32.6%) experienced PMD with two of every three urinations. PMD with every urination was experienced by 34 patients (24.6%). More than half of the patients (89 patients, 65.4%) indicated that persistent PMD symptoms would likely result in moderate to severe discomfort in their daily activities. As time passed, the udenafil group showed significant improvement in PMD symptoms (p = 0.001).Conclusion: Udenafil 75 mg once daily can be an effective treatment for patients with PMD symptoms. [ABSTRACT FROM AUTHOR]

Simple Summary: Patients with multiple myeloma (MM) who become refractory to three or more lines of therapy (RRMM patients) have few valid therapeutic alternatives. Among them, drugs directed against the BCMA antigen expressed in plasma cells are very appealing. Belantamab-mafodotin (belamaf) is the first antibody-drug conjugate against BCMA ready for clinical use. In this paper, we report the Spanish experience of belamaf monotherapy in 156 patients with RRMM. The overall response rate was 41.8%, with 39.8% of patients achieving a partial response or better. Median progression-free survival was 3.61 months, but interestingly, it increased to 14.47 months in patients achieving a minimal response or better. Treatment was well tolerated, ocular events being the most reported toxicity (87.9%; grade ≥ 3, 33.7%), but only two patients discontinued treatment due to side effects. Overall, our results confirm the safety and efficacy of belamaf in this poor prognosis subset of patients. Belantamab-mafodotin (belamaf) is a novel antibody-drug conjugate targeting B-cell maturation antigen that showed anti-myeloma activity in patients with relapsed and refractory multiple myeloma (RRMM). We performed an observational, retrospective, and multicenter study aimed to assess the efficacy and safety of single-agent belamaf in 156 Spanish patients with RRMM. The median number of prior therapy lines was 5 (range, 1–10), and 88% of patients were triple-class refractory. Median follow-up was 10.9 months (range, 1–28.6). The overall response rate was 41.8% (≥CR 13.5%, VGPR 9%, PR 17.3%, MR 2%). The median progression-free survival was 3.61 months (95% CI, 2.1–5.1) and 14.47 months (95% CI, 7.91–21.04) in patients achieving at least MR (p < 0.001). Median overall survival in the entire cohort and in patients with MR or better was 11.05 months (95% CI, 8.7–13.3) and 23.35 (NA-NA) months, respectively (p < 0.001). Corneal events (87.9%; grade ≥ 3, 33.7%) were the most commonly adverse events, while thrombocytopenia and infections occurred in 15.4% and 15% of patients, respectively. Two (1.3%) patients discontinued treatment permanently due to ocular toxicity. Belamaf showed a noticeably anti-myeloma activity in this real-life series of patients, particularly among those achieving MR or better. The safety profile was manageable and consistent with prior studies. [ABSTRACT FROM AUTHOR]

Simple Summary: Since the introduction of effective systemic therapies (ESTs) (in the form of both targeted and immuno-based therapies) in the treatment of malignant melanoma, the prognosis of metastatic patients has dramatically changed. The role of metastasectomy in oligometastatic patients has rarely been addressed in this new pharmacological era. Even though lungs represent the most frequent site of melanoma metastases, only limited data are available on the role of surgery in isolated pulmonary metastases from malignant melanoma (PmMM). In this study, we describe the outcomes of patients who underwent metastasectomy of PmMM in the era of ESTs, and identified prognostic factors affecting survival in our multicentric experience. To the best of our knowledge, this is the first paper analyzing in detail the impact of metastasectomy of PmMM in the era of ESTs. In the last decade, the emergence of effective systemic therapies (ESTs) in the form of both targeted and immuno-based therapies has revolutionized the treatment of patients with advanced stage III and stage IV melanoma. Even though lungs represent the most frequent site of melanoma metastases, only limited data are available on the role of surgery in isolated pulmonary metastases from malignant melanoma (PmMM) in the era of ESTs. The aim of this study is to describe the outcomes of patients who underwent metastasectomy of PmMM in the era of ESTs, in order to identify prognostic factors affecting survival and to provide a framework for more informed patient selection of treatmeant with lung surgery in the future. Clinical data of 183 patients who underwent metastasectomy of PmMM between June 2008 and June 2021 were collected among four Italian Thoracic Centers. The main clinical, surgical and oncological variables reviewed were: sex, comorbidities, previous oncological history, melanoma histotypes and primary site, date of primary cancer surgical treatment, melanoma growth phase, Breslow thickness, mutation pattern disease, stage at diagnosis, metastatic sites, DFI (Disease Free Interval), characteristics of lung metastases (number, side, dimension, type of resection), adjuvant therapy after lung metastasectomy, site of recurrence, disease-free survival (DFS) and cancer-specific survival (CSS; defined as the time interval between the first melanoma resection or lung metastasectomy and death from cancer). All patients underwent surgical resection of the primary melanoma before lung metastasectomy. Twenty-six (14.2%) patients already had a synchronous lung metastasis at the time of primary melanoma diagnosis. A wedge resection was performed in 95.6% of cases to radically remove the pulmonary localizations, while an anatomical resection was necessary in the remaining cases. The incidence of major post-operative complications was null, while only 21 patients (11.5%) developed minor complications (mainly air leakage followed by atrial fibrillation). The mean in-hospital stay was 4.46 ± 2.8 days. Thirty- and sixty-day mortality were null. After lung surgery, 89.6% of the population underwent adjuvant treatments (47.0% immunotherapy, 42.6% targeted therapy). During a mean FUP of 107.2 ± 82.3 months, 69 (37.7%) patients died from melanoma disease, 11 (6.0%) from other causes. Seventy-three patients (39.9%) developed a recurrence of disease. Twenty-four (13.1%) patients developed extrapulmonary metastases after pulmonary metastasectomy. The CSS from melanoma resection was: 85% at 5 years, 71% at 10 years, 54% at 15 years, 42% at 20 years and 2% at 25 years. The 5- and 10-year CSS from lung metastasectomy were 71% and 26%, respectively. Prognostic factors negatively affecting CSS from lung metastasectomy at multivariable analysis were: melanoma vertical growth (p = 0.018), previous metastatic sites other than lung (p < 0.001) and DFI < 24 months (p = 0.007). Our results support the evidence that surgical indication confirms its important role in stage IV melanoma with resectable pulmonary metastases, and selected patients can still benefit from pulmonary metastasectomy in terms of overall cancer specific survival. Furthermore, the novel systemic therapies may contribute to prolonged survival after systemic recurrence following pulmonary metastasectomy. Patients with long DFI, radial growth melanoma phase and no site of metastatization other than lung seem to be the best candidate cases for lung metastasectomy; however, to drive stronger conclusions, further studies evaluating the role of metastasectomy in patients with iPmMM are needed. [ABSTRACT FROM AUTHOR]

Background & Aim: To assess consonant proficiency and velopharyngeal function in 10‐year‐old children born with unilateral cleft lip and palate (UCLP) within the Scandcleft project. Methods & Procedures: Three parallel group, randomized, clinical trials were undertaken as an international multicentre study by nine cleft teams in five countries. Three different surgical protocols for primary palate repair (Arm B–Lip and soft palate closure at 3–4 months, hard palate closure at 36 months, Arm C–Lip closure at 3–4 months, hard and soft palate closure at 12 months, and Arm D–Lip closure at 3–4 months combined with a single‐layer closure of the hard palate using a vomer flap, soft palate closure at 12 months) were tested against a common procedure (Arm A–Lip and soft palate closure at 3–4 months followed by hard palate closure at 12 months) in the total cohort of 431 children born with a non‐syndromic UCLP. Speech audio and video recordings of 399 children were available and perceptually analysed. Percentage of consonants correct (PCC) from a naming test, an overall rating of velopharyngeal competence (VPC) (VPC‐Rate), and a composite measure (VPC‐Sum) were reported. Outcomes & Results: The mean levels of consonant proficiency (PCC score) in the trial arms were 86–92% and between 58% and 83% of the children had VPC (VPC‐Sum). Only 50–73% of the participants had a consonant proficiency level with their peers. Girls performed better throughout. Long delay of the hard palate repair (Arm B) indicated lower PCC and simultaneous hard and soft palate closure higher (Arm C). However, the proportion of participants with primary VPC (not including velopharyngeal surgeries) was highest in Arm B (68%) and lowest in Arm C (47%). Conclusions & Implications: The speech outcome in terms of PCC and VPC was low across the trials. The different protocols had their pros and cons and there is no obvious evidence to recommend any of the protocols as superior. Aspects other than primary surgical method, such as time after velopharyngeal surgery, surgical experience, hearing level, language difficulties and speech therapy, need to be thoroughly reviewed for a better understanding of what has affected speech outcome at 10 years. WHAT THIS PAPER ADDS: What is already known on the subject: Speech outcomes at 10 years of age in children treated for UCLP are sparse and contradictory. Previous studies have examined speech outcomes and the relationship with surgical intervention in 5‐year‐olds. What this study adds to the existing knowledge: Speech outcomes based on standardized assessment in a large group of 10‐year‐old children born with UCLP and surgically treated according to different protocols are presented. While speech therapy had been provided, a large proportion of the children across treatment protocols still needed further speech therapy. What are the potential or actual clinical implications of this work?: Aspects other than surgery and speech function might add to the understanding of what affects speech outcome. Effective speech therapy should be available for children in addition to primary surgical repair of the cleft and secondary surgeries if needed. [ABSTRACT FROM AUTHOR]

Purpose: This paper is a commentary inspired by Laura McKenzie-Smith's review paper. Design/methodology/approach: This commentary provides a personal perspective on the intersections of narrative practice and the support of people with a learning disability. Findings: This commentary highlights some further possibilities of narrative ideas beyond therapy. This paper explores examples of record keeping and research as sites for story construction about lives and identities. Research limitations/implications: This is a personal perspective of a systemic psychotherapist and academic working with people with a learning disability. Practical implications: This paper argues that the stories we tell ourselves and others about our work and the people we support are powerful in ways of which we may not always be aware. Social implications: In common with person-centred planning, narrative ideas highlight the power of the stories circulating about a person and their network and the implications they may have for their lives and identities. Originality/value: This commentary explores narrative practices beyond the context of therapy, highlighting organisational, administrative and research practices as story-constructing activities that co-create identities of persons with a learning disability, their networks of support and health and social care professionals. [ABSTRACT FROM AUTHOR]

This lecture was presented in honour and memory of Patricia Mary Lance in recognition of her contribution to orthoptics in the fields of research, education and the association, both in Australia and internationally. After seven years of publishing the transactions of the annual scientific meetings, the first titled edition of the Australian Orthoptic Journal was published in 1966 as Volume 8, which means that 2016 marked 50 years of our journal with its current name. This anniversary provided an opportune time to look back over the journal and its development over the decades, from the very first orthoptic paper in the transactions of the 1959 meeting, which was by Patricia Lance, to the latest research publications in 2015. Over this time the changes in society, culture, education and technology have all affected the development of research and this has been reflected in our journal. [ABSTRACT FROM AUTHOR]

Aims: This study compared two dose frequency conditions of an explicit intervention with 50 trials per session designed to improve past tense marking in early school‐aged children with developmental language disorder (DLD). The influence of allomorphs on intervention effects was also examined. Methods: Data from previously conducted intervention studies were combined and analysed. Participants included nine children (mean age = 6;5 years) who received 20–30‐min intervention sessions provided twice per week for 10 weeks (1000 trials; 400–600 min) and 20 children (mean age = 6;6) who received 20–30‐min intervention sessions provided once per week for 10 weeks (500 trials; 200–300 min). Repeated measures included criterion‐referenced probes for production of untrained past tense verbs collected throughout baseline, intervention, and maintenance phases. The rate of progress in each phase was analysed using logistic regression. The proportion of participants who produced past tense allomorphs correctly at pre‐intervention, post‐intervention, and maintenance testing points was analysed. Results: Logistic regression showed a stable baseline, highly significant progress during the intervention phase, and a marginally significant shallow decline during the maintenance phase. Those in the twice per week group showed a greater rate of progress during the intervention phase leading to significantly higher scores in the maintenance period when compared with the once per week group. The allomorphic category of past tense verbs did not appear to influence outcomes. Conclusions: Participants receiving intervention twice per week appeared to demonstrate a greater rate of progress with intervention than those receiving it once per week, although once per week was also effective. However, these results should be interpreted with caution. Limitations to study design indicate that a larger randomised controlled trial is required. All past tense allomorphs improve to a similar degree when treated with this intervention. What this paper adds: What is already known on the subject: Understanding the parameters of dosage and intensity are important for clinical practice.Research evaluating the efficacy and/or effectiveness of interventions delivered in different dose/intensity conditions is scarce.There appears to be different interpretations of what constitutes dosage and intensity in published research. What this paper adds to existing knowledge: This study retrospectively compared dosage and intensity conditions of intervention provided twice per week to intervention provided once per week. Both dose frequencies could be delivered in clinical settings.Results from this study were analysed by grouping data from multiple testing points, rather than comparing pre‐post results. This approach demonstrated the variability of individual performance that would otherwise be lost with conventional methods of analysis.This study demonstrated that all past tense allomorphs improve to a similar degree when treated with this intervention. What are the potential or actual clinical implications of this work?: Parameters of dosage and intensity are still not clearly defined well enough for translation to clinical practice. In consideration of current research, this intervention may be more effective if delivered twice per week.If clinicians are treating past tense, all allomorphs should be considered as priorities for intervention targets. [ABSTRACT FROM AUTHOR]

The Sequential Intercept Model has helped conceptualize interventions for people with serious mental illness in the criminal/legal system. This paper operationalizes the Sequential Intercept Model into a 35-item scorecard of behavioral health and legal practices. Using interviews, survey, and observational methods, the scorecard assesses an exploratory sample of 19 counties over 27 independent data collections. A series of ordinary least squares regression models assessed the predictor scores on four jail outcomes: prevalence of serious mental illness, length of stay, connections to treatment, and recidivism. Increases in pre-booking scores showed significant decreases in jail prevalence of serious mental illness at the p < 0.05 level, and post-booking scores and overall scores showed significant positive associations with connections to treatment at the p < 0.05 level, though these were non-significant after correcting for multiple comparisons. Preliminary findings suggest a combination of practices across the Sequential Intercept Model could have synergistic impacts on key jail diversion outcomes. [ABSTRACT FROM AUTHOR]

Background: The subcutaneous implantable‐defibrillator (S‐ICD) is a relatively new alternative to the transvenous ICD system to minimize intravascular lead‐related complications. This paper presents outcome of SICD implantation in patients enrolled in Iran S‐ICD registry. Methods: Between October 2015 and June 2022, this prospective multicenter national registry included 223 patients with a standard indication for an ICD, who neither required bradycardia pacing nor needed cardiac resynchronization to evaluate the early post‐implant complications and long‐term follow‐up results of the S‐ICD system. Results: The mean age of the patients was 45 ± 17 years. The majority (79.4%) were male. Ischemic cardiomyopathy (39.5%) was the most common underlying disorder among patients selected for S‐ICD implant. Most study patients (68.6%) had ICD for primary prevention of sudden cardiac death. Seven patients (3.1%) were found to have suboptimal lead positions. Six patients (2.7%) developed a pocket hematoma; all were managed medically. During a mean follow‐up of 2 years, the appropriate therapy was recorded in 13% of the patients and inappropriate ICD intervention mainly due to supraventricular tachycardia in 8.9%. Pocket infection was observed in four patients (1.8%) and five patients (2.2%) died mainly due to heart failure. Conclusion: S‐ICDs were effective at detecting and treating both induced and spontaneous ventricular arrhythmias. Major clinical complications were rare. [ABSTRACT FROM AUTHOR]

Purpose: To compare the outcomes of immediate and delayed implant placement with bone-level tapered implants. Materials and Methods: In this post-market, multicenter prospective randomized controlled study with a primary endpoint of 1 year, 53 patients were randomized to receive either immediate implant placement (test group) or delayed implant placement (control group). The mean crestal bone level changes from implant loading to 12 months postloading were measured using standardized digital periapical radiographs. Changes in facial plate thickness (as measured on CBCT images), implant success and survival, implant stability, soft tissue changes, patient-centered outcomes, and adverse events were measured to assess outcomes between the test and control treatments at 12 months postloading. Results: Of the original 53 patients, 46 patients completed the study (23 in each group). Mean bone changes from loading to the 12-month follow-up were recorded with no statistically significant difference (P = .950) between the groups. The hypothesis was confirmed that immediate implant placement (test) in extraction sockets produces in similar outcomes as delayed placement (control). The test group was found to be similar to the control group (P = .022) in terms of mean changes in facial plate thickness. Implant survival and success were 95.8% in the test group and 92% in the control group. Stability in the control group was superior at the time of surgery, but there was no difference between the groups at implant loading, producing a nonsignificant P value of .563). Conclusions: This randomized controlled multicenter study showed comparable outcomes 1 year after prosthetic loading in the immediate and delayed implant placement groups. [ABSTRACT FROM AUTHOR]

Objective: To determine the effects on weight loss of three abbreviated behavioral weight loss interventions with and without coaching and mobile technology.Methods: A randomized controlled efficacy study of three 6-month weight loss treatments was conducted in 96 adults with obesity: 1) self-guided (SELF), 2) standard (STND), or 3) technology-supported (TECH). STND and TECH received eight in-person group treatment sessions. SELF and STND used paper diaries to self-monitor diet, activity, and weight; TECH used a smartphone application with social networking features and wireless accelerometer.Results: Weight loss was greater for TECH and STND than SELF at 6 months (-5.7 kg [95% confidence interval: -7.2 to -4.1] vs. -2.7 kg [95% confidence interval: -5.1 to -0.3], P < 0.05) but not 12 months. TECH and STND did not differ except that more STND (59%) than TECH (34%) achieved ≥ 5% weight loss at 6 months (P < 0.05). Self-monitoring adherence was greater in TECH than STND (P < 0.001), greater in both interventions than SELF (P < 0.001), and covaried with weight loss (r(84) = 0.36-0.51, P < 0.001).Conclusions: Abbreviated behavioral counseling can produce clinically meaningful weight loss regardless of whether self-monitoring is performed on paper or smartphone, but long-term superiority over standard of care self-guided treatment is challenging to maintain. [ABSTRACT FROM AUTHOR]

Background: Treatment fidelity refers to the degree to which an intervention is implemented as intended. Promoting treatment fidelity is important to achieve a valid comparison in intervention research. However, it is often underreported: few studies detail the use and development of fidelity measures. This study aims to promote the treatment fidelity of a modified version of the Derbyshire Language Scheme (M‐DLS), a manualised intervention for children with language difficulties, by exploring participants' opinions on training and intervention delivery. Results inform development of a checklist and scoring system to monitor and promote treatment fidelity in a comparison trial. Method: Ten student speech and language therapists (SLTs) and two research assistants (RAs) participated in the study. All received training on the M‐DLS, and 10 were video‐recorded completing role‐plays of an M‐DLS session in small groups. Feedback was gathered after training and role‐plays in focus groups and interviews. Feedback was interpreted using the constructs of the Theoretical Domains Framework (TDF). A treatment fidelity checklist was then developed using the feedback. The first author and two RAs rated role‐play videos using the checklist to trial it to inform amendments and to promote interrater reliability. Interrater agreement was calculated using Spearman's test of correlation. Results: Participants discussed the importance of having clear materials and time to practise sessions. They suggested amendments to the materials and training to promote treatment fidelity. The checklist and scoring system accounted for participants' suggestions, with amendments detailed in a log. Spearman's correlation results suggested agreement between the raters was strong. Conclusions: Results emphasise the importance of training quality, practice and reflective opportunities and clear materials to promote treatment fidelity. The construction of the checklist and scoring system was described in detail, informing the development of future checklists. After further trialling, the checklist can be used to ensure the M‐DLS is delivered with high treatment fidelity in the comparison trial. What this paper adds: What is already known on this subject: Treatment fidelity is an essential component of intervention effectiveness and efficacy studies, ensuring the intervention is delivered as intended. It is also an essential component of evidence-based clinical practice. However, few research studies report the treatment fidelity process or publish the checklists used, depriving clinicians of useful information for implementation. What this study adds: This study describes in detail the iterative process of treatment fidelity checklist development, engaging those implementing the intervention in development. This ensured clarity and interrater reliability of the checklist. Furthermore, a novel scoring system was developed so that accuracy of implementation can be easily compared across users and across practice attempts. What are the clinical implications of this work?: The importance of treatment fidelity when implementing effective and efficacious interventions cannot be overstated. The treatment fidelity checklist developed for research can be easily adopted to support accurate implementation in clinical practice through an audit process. [ABSTRACT FROM AUTHOR]

BACKGROUND: Vision impairments affect the ability to navigate environments and gain spatial perception of one's surroundings. Existing navigation aids typically provide close-range information, but not feedback on farther distances (i.e., beyond 5 m from the user). OBJECTIVE: To address this gap, the OptiBand, a custom assistive device, was previously designed with a stakeholder who is blind. The OptiBand uses Lidar sensing and haptic feedback to relay information on objects up to 15 m away. In this paper, we sought to evaluate the efficacy of the OptiBand with an in situ user study. METHODS: N = 9 participants (eight blind and one low-vision) used the OptiBand for a period of three months. Users periodically rated spatial perception workload and trust of their assistive navigation aids (at first as a baseline without the OptiBand, and then with the OptiBand). RESULTS: The OptiBand tended to yield lower workload requirements and similar trust levels compared to existing navigation aids. Interview data demonstrated the usefulness of the OptiBand in selected day-to-day tasks such as navigating outdoors and maintaining appropriate interpersonal spacing. CONCLUSIONS: This work provides evidence on benefits of and potential uses of assistive navigation aids like the OptiBand. Researchers interested in similar devices can benefit from our efforts. [ABSTRACT FROM AUTHOR]

Chronic primary low back pain (CPLBP) is a prevalent and disabling condition that often requires rehabilitation interventions to improve function and alleviate pain. This paper aims to advance future research, including systematic reviews and randomized controlled trials (RCTs), on CPLBP management. We provide methodological and reporting recommendations derived from our conducted systematic reviews, offering practical guidance for conducting robust research on the effectiveness of rehabilitation interventions for CPLBP. Our systematic reviews contributed to the development of a WHO clinical guideline for CPLBP. Based on our experience, we have identified methodological issues and recommendations, which are compiled in a comprehensive table and discussed systematically within established frameworks for reporting and critically appraising RCTs. In conclusion, embracing the complexity of CPLBP involves recognizing its multifactorial nature and diverse contexts and planning for varying treatment responses. By embracing this complexity and emphasizing methodological rigor, research in the field can be improved, potentially leading to better care and outcomes for individuals with CPLBP. [ABSTRACT FROM AUTHOR]

Treatment success is the desired outcome in aphasia rehabilitation. However, to date, there is a lack of consensus on what defines a 'successful' result on a given aphasia outcome measurement instrument (OMI). In this methodological paper, we present strategies for how to define and measure treatment success on a given OMI at the group-level, as well as for an individual person with aphasia. The latter is particularly important when research findings from group studies are clinically implemented for individuals in rehabilitation. We start by presenting methods to calculate the average statistically significant change across several (group) studies (e.g., standardised mean difference, raw unstandardised mean difference) for a given OMI. Such metrics are useful to summarise the overall effect of the intervention of interest, particularly in meta-analyses. However, benchmarks based on group effects are not feasible for assessing an individual participant's treatment success and thus for determining the proportion of patients who had a beneficial response to therapy (overall response rate of an intervention). We therefore recommend a distribution-based approach to determine benchmarks of a statistically significant treatment response at the individual level, i.e., the 'smallest detectable change' for a given OMI, which refers to the smallest change that can be detected by the OMI beyond measurement error. However, the statistical significance of an individual treatment effect does not necessarily correspond to its clinical impact. This requires an additional indicator. The benchmark to determine a clinically relevant improvement on a given OMI is the 'minimal important change'. The minimally important change is defined as the smallest OMI change score perceived as important by the relevant stakeholder group (i.e., people with aphasia, their relatives/caregivers, clinicians). It therefore requires relating the individual OMI change scores to 'anchors', i.e., meaningful external criteria, preferably based on patient-perceived therapy success. Currently, there is no consensus regarding the optimal 'anchors' and their respective definition of clinically important change in aphasia outcome research. Operationalising individual treatment success based on both statistically significant and (patient-reported) clinically meaningful benchmarks is a key priority in aphasia rehabilitation. Availability of such measures will (a) facilitate estimates of therapy response rate in intervention studies and thus optimise therapeutic decisions and (b) provide stakeholder groups (e.g., the society, the stroke team, people with aphasia, family, clinicians, healthcare professionals) with objective, statistically reliable and meaningful feedback on individual treatment response in the clinical setting. [ABSTRACT FROM AUTHOR]

Background: Several medications have been applied to Alzheimer's dementia patients (AD) but their efficacies have been insufficient. The efficacy and safety of 4 weeks of repetitive transcranial magnetic stimulation (rTMS) in Japanese AD were evaluated in this exploratory clinical trial. Methods: Forty-two patients, aged 60-93 years (average, 76.4 years), who were taking medication (> 6 months) and had Mini-Mental State Examination (MMSE) scores ≤ 25 and Clinical Dementia Rating Scale scores (CDR-J) of 1 or 2, were enrolled in this single-center, prospective, randomized, three-arm study [i.e., 120% resting motor threshold (120% RMT), 90% RMT for the bilateral dorsolateral prefrontal cortex, and Sham]. Alzheimer's Disease Assessment Scale-Japanese Cognitive (ADAS-J cog), Montreal Cognitive Assessment (MoCA-J), Clinical Global Impression of Change (CGIC), Neuropsychiatric inventory (NPI), and EuroQOL 5 Dimensions 5-Level (EQ-5D-5L) were administered. The primary endpoint was the mean change from baseline in the MMSE score (week 4). An active rTMS session involved applying 15 trains bilaterally (40 pulses/train at 10 Hz; intertrain interval, 26 s). Participants received ≥ 8 interventions within the first 2 weeks and at least one intervention weekly in the 3rd and 4th weeks. Full Analysis set (FAS) included 40 patients [120% RMT (n = 15), 90% RMT (n = 13), and Sham (n = 12)]. Results: In the FAS, MMSE, ADAS-J cog, MoCA-J, CDR-J, CGIC, NPI, and EQ-5D-5L scores between the three groups were not significantly different. Two patients were erroneously switched between the 120% RMT and 90% RMT groups, therefore, "as treated" patients were mainly analyzed. Post hoc analysis revealed significant treatment efficacy in participants with MMSE scores ≥ 15, favoring the 120% RMT group over the Sham group. Responder analysis revealed 41.7% of the 120% RMT group had a ≥ 3-point improvement in the ADAS-J cog versus 0% in the Sham group (Fisher's exact test, p = 0.045). The MoCA-J showed the same tendency but was not significant. Efficacy disappeared in week 20, based on the ADAS-cog and MoCA-J. No intervention-related serious adverse events occurred. Conclusion: This paper is the first report of using rTMS in Japanese AD patients. The treatment seems safe and moderate-mild stage AD should be target population of pivotal clinical trial with 120% RMT rTMS. [ABSTRACT FROM AUTHOR]

Propensity score methods are commonly used in statistical analyses of observational data to reduce the impact of confounding bias in estimations of average treatment effect. While the propensity score is defined as the conditional probability of a subject being in the treatment group given that subject's covariates, the most precise estimation of average treatment effect results from specifying the propensity score as a function of true confounders and predictors only. This property has been demonstrated via simulation in multiple prior research articles. However, we have seen no theoretical explanation as to why this should be so. This paper provides that theoretical proof. Furthermore, this paper presents a method for performing the necessary variable selection by means of elastic net regression, and then estimating the propensity scores so as to obtain optimal estimates of average treatment effect. The proposed method is compared against two other recently introduced methods, outcome-adaptive lasso and covariate balancing propensity score. Extensive simulation analyses are employed to determine the circumstances under which each method appears most effective. We applied the proposed methods to examine the effect of pre-cardiac surgery coagulation indicator on mortality based on a linked dataset from a retrospective review of 1390 patient medical records at Jewish Hospital (Louisville, KY) with the Society of Thoracic Surgeons database. [ABSTRACT FROM AUTHOR]

Background: Electronic patient-reported outcome (ePRO) systems are increasingly used in clinical trials to provide evidence of efficacy and tolerability of treatment from the patient perspective. The aim of this study is twofold: (1) to describe how we developed an electronic platform for patients to report their symptoms, and (2) to develop and undertake usability testing of an ePRO solution for use in a study of cell therapy seeking to provide early evidence of efficacy and tolerability of treatment and test the feasibility of the system for use in later phase studies. Methods: An ePRO system was designed to be used in a single arm, multi-centre, phase II basket trial investigating the safety and activity of the use of ORBCEL-C™ in the treatment of patients with inflammatory conditions. ORBCEL-C™ is an enriched Mesenchymal Stromal Cells product isolated from human umbilical cord tissue using CD362+ cell selection. Usability testing sessions were conducted using cognitive interviews and the 'Think Aloud' method with patient advisory group members and Research Nurses to assess the usability of the system. Results: Nine patient partners and seven research nurses took part in one usability testing session. Measures of fatigue and health-related quality of life, the PRO-CTCAE™ and FACT-GP5 global tolerability question were included in the ePRO system. Alert notifications to the clinical team were triggered by PRO-CTCAE™ and FACT-GP5 scores. Patient participants liked the simplicity and responsiveness of the patient-facing app. Two patients were unable to complete the testing session, due to technical issues. Research Nurses suggested minor modifications to improve functionality and the layout of the clinician dashboard and the training materials. Conclusion: By testing the effectiveness, efficiency, and satisfaction of our novel ePRO system (PROmicsR), we learnt that most people with an inflammatory condition found it easy to report their symptoms using an app on their own device. Their experiences using the PROmicsR ePRO system within a trial environment will be further explored in our upcoming feasibility testing. Research nurses were also positive and found the clinical dashboard easy-to-use. Using ePROs in early phase trials is important in order to provide evidence of therapeutic responses and tolerability, increase the evidence based, and inform methodology development. Trial registration: ISRCTN, ISRCTN80103507. Registered 01 April 2022, https://www.isrctn.com/ISRCTN80103507 Plain English summary: More and more patients tell clinicians how they feel by completing questionnaires electronically. Therefore, it is important to assess how easy it is for patients to do this. In this study, we describe how we developed an electronic platform for patients to report their symptoms and how we tested the usability of this platform with patient partners and research nurses. Once the electronic platform was developed, quality of life and symptoms questionnaires were programmed onto it. Alerts were sent to the clinical team if specific scores were obtained on the symptoms questionnaires. Although two patient partners were not able to finish the testing session because of technical issues, the ones who completed the session liked its simplicity and responsiveness. The research nurses also liked the system and only suggested minor modifications. Following this testing, we refined the electronic platform to test it further in a larger study which investigates the safety and use of a drug. We hope that thanks to this electronic platform, we will obtain useful information on the safety and efficacy of treatment. [ABSTRACT FROM AUTHOR]

A co-design project, consisting of individual and collective design activities, was organized with clients of a mental health service, in order to explore its potential to support people with psychosis. The group met for approximately two hours, weekly, for six months, participating in design activities and collectively deciding on the project purpose and outcome – a boardgame. The experience of one group participant (Anthony) is explored, selected as the first case study within an Interpretative Phenomenological Analytical (IPA) framework. Following IPA's ideographic focus, Anthony's case was purposefully selected, as it portrayed a detailed picture, informing theoretical reflection on designing as therapeutic. The paper includes Anthony's first-hand account, combined with an analysis of data from three semi-structured interviews, photographic evidence and a reflective diary kept by the lead researcher. Results suggest that, for Anthony, design activity: a) helps developing a sense of agency b) is experienced as grounding in reality c) contributes to the development of inter-personal relationships, and d) has a different sense of rhythm than artistic practice. These results are contextualized within literature on the lived experience of psychosis and suggest that designing can be beneficial for people with psychosis, providing the backdrop for further research and practice. [ABSTRACT FROM AUTHOR]

Background: Violence exacts staggering personal and financial costs – a burden disproportionally born by adolescents and young adults. This may be partially due to an increased sensitivity to social rejection during this critical phase of development. Irritability, a transdiagnostic symptom, is often elicited by social interactions. Yet, little is known about age differences in social rejection‐elicited aggression and irritability. Progress toward testing such relations has been hindered by a lack of ecologically‐valid tasks that enable the measurement of in‐the‐moment social rejection‐elicited aggression. Methods: In this paper, we describe an initial study of young adults (n = 55) that demonstrates the efficacy of a novel Virtual School and Aggression Paradigm (VS‐AP). Next, we replicate these results in a second study of adolescents and young adults (ages 11–25 years; n = 173) and examine relations between social rejection‐elicited aggression, irritability, and age. Results: We found that aggressive behavior in the VS‐AP differed for accepting, rejecting, and unpredictable peer types (Study 1: F(2, 108) = 20.57, p <.001, ε2 =.28; Study 2: F(2, 344) = 152.13, p <.001, ε2 =.47), demonstrating that the VS‐AP successfully models social rejection‐elicited aggression. In Study 2, age was negatively correlated with aggressive behavior (r = −.29, p <.001) and irritability (r = −.28, p <.001), while irritability was positively correlated with aggressive behavior (r =.28, p <.001). Age moderated the relation between social rejection‐elicited aggression and irritability. Specifically, irritability was more predictive of aggression in young adults than in adolescents (F(3, 167) = 7.07, p <.001). Conclusions: Data suggest mechanisms promoting rejection‐elicited aggression may differ across development and vary for those with and without high levels of irritability. The VS‐AP is a promising tool for probing neurocognitive, developmental, and clinically relevant mechanisms underlying social rejection‐elicited aggression. [ABSTRACT FROM AUTHOR]

Pectus excavatum is the most common congenital anterior chest wall deformity, with an incidence of 1:400 to 1:1000. Surgical strategy has evolved with the revolutionary idea of Donald Nuss, who was a pioneer in the operative correction of this deformity using minimally invasive surgery. The aim of this paper is to compare the preliminary results of pectus excavatum repair in two University Centers with a moderate number of patients using the standard Nuss procedure and its modification, the extrapleural thoracoscopic approach. The statistical analysis showed no significant difference for the patient's age (14.52 ± 3.70 vs. 14.57 ± 1.86; p = 0.95) and the CT Haller index (4.17 ± 1.58 vs. 3.78 ± 0.95; p = 0.32). A statistically significant difference was noted for the duration of a pectus bar implant (2.16 ± 0.24 vs. 2.48 ± 0.68; p = 0.03) between the Maribor and Novi Sad Center. We report 14 complications (28%), including dislocation of the pectus bar (10%), pleural effusion (8%), wound inflammation (6%), pericarditis (2%) and an allergic reaction to the pectus bar (2%). Standard and thoracoscopic extrapleural Nuss procedures are both safe and effective procedures used to correct a pectus excavatum deformity. The choice of surgical procedure should be made according to a surgeon's reliability in performing a particular procedure. Our study found no advantages of one procedure over the other. [ABSTRACT FROM AUTHOR]

Physical activity is a factor by which mental health can be improved. However, the association between mental health and physical exercise, in a "team-based sport" setting within the community, remains unclear. The current paper aims to provide an evaluation of a football programme, implemented by Time to Change Wales, funded by the Welsh Government, to improve mental health. Participants attended weekly 90–120 minute football sessions, held in local community venues across Wales, UK, with no requirement on the number of sessions that participants had to attend. A qualitative method was employed to explore the experiences of those who took part. Individuals who participated in the programme reported psychosocial and physical benefits, such as improved physical and mental health, improved social confidence and having a sense of purpose added to their day-to-day living. Factors affecting participation were also identified within the data, such as environmental barriers. Conclusion: The findings provide both support and contextual extension to previous research in this area; demonstrating the positive effects of sport-based therapy for those with mental health difficulties. Implications and conclusions should be used to inform future research into developing community sport-based programmes to improve mental health. [ABSTRACT FROM AUTHOR]

Introduction: This paper provides a report of social validity and its usefulness in understanding study effects. Social validity data were drawn from a larger single-case study designed to investigate the effectiveness of the Matrix Approach in the practice of early intervention visual impairment professionals. Methods: Qualitative measures were used to assess social validity. According to Wolf (1978), validation of a study should encompass the significance of goals, appropriateness of procedures, and importance of outcomes. Therefore, data sources were created to provide evidence of social validity in these areas including pre- and post-intervention interviews of parents and professionals. Results: Three themes emerged from the social validity data. These are organized under the topics introduced by Wolf (1978) and identified as measures of quality by Horner et al. (2005). The themes are (a) Goals: role of the parent as learner and the professional as expert before using the Matrix Approach, (b) Procedures: helpfulness of coaching and the structure of the Matrix Approach, and (c) Outcomes: personal and professional growth as a result of using the Matrix Approach. Discussion: Evaluation of social validity in single-case research is an important component in a study's design and in interpreting the study's outcomes. Wolf's framework proved valuable in promoting a robust evaluation of study effectiveness, especially when incorporated into the study design. Intentionally planning to measure social validity held the researchers accountable to the practical needs of the participants. In fact, there is value in gathering social validity data at various points in a study. Further, hearing the perspective of stakeholders can provide valuable insights as researchers seek to understand the complexities of change evident in the outcomes of a study. Implications for Practitioners: Collaborative planning is an essential component of early intervention. The Matrix Approach shows promise as a mechanism to foster such collaboration. [ABSTRACT FROM AUTHOR]

The relationship between self-awareness (insight) and outcome following acquired brain injury (ABI) is well recognised, but evidence suggests that information regarding brain injury and its cognitive impact is not adequately conveyed to social workers, or appropriately considered when assessing support needs and a person's capacity to make decisions about their care. The Brain Injury Needs Indicator (BINI) provides a solution, by enabling the valid assessment of the needs of those with brain injuries living in a community setting. This paper investigated associations between impaired insight, functional outcome of brain injury, and level of risk, and validated the use of the BINI as an indicator of need. A high prevalence of severe disability (73 per cent) and low insight (30 per cent) was found in a sample of thirty individuals with ABI. The composite BINI score was the measure most strongly related with a clinical assessment of risk (rs = 0.72, N  =   26). Self-report methods may underestimate support needs, especially in those with low levels of insight into their difficulties. The BINI, which combines outcome post-ABI with a measure of insight, provides a more accurate estimate of risk than either measure individually. It is important to include both areas in individual needs assessments. [ABSTRACT FROM AUTHOR]

Background: In the last few decades, the number of trials using Bayesian methods has grown rapidly. Publications prior to 1990 included only three clinical trials that used Bayesian methods, but that number quickly jumped to 19 in the 1990s and to 99 from 2000 to 2012. While this literature provides many examples of Bayesian Adaptive Designs (BAD), none of the papers that are available walks the reader through the detailed process of conducting a BAD. This paper fills that gap by describing the BAD process used for one comparative effectiveness trial (Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations) that can be generalized for use by others. A BAD was chosen with efficiency in mind. Response-adaptive randomization allows the potential for substantially smaller sample sizes, and can provide faster conclusions about which treatment or treatments are most effective. An Internet-based electronic data capture tool, which features a randomization module, facilitated data capture across study sites and an in-house computation software program was developed to implement the response-adaptive randomization.Results: A process for adapting randomization with minimal interruption to study sites was developed. A new randomization table can be generated quickly and can be seamlessly integrated in the data capture tool with minimal interruption to study sites.Conclusion: This manuscript is the first to detail the technical process used to evaluate a multisite comparative effectiveness trial using adaptive randomization. An important opportunity for the application of Bayesian trials is in comparative effectiveness trials. The specific case study presented in this paper can be used as a model for conducting future clinical trials using a combination of statistical software and a web-based application.Trial Registration: ClinicalTrials.gov Identifier: NCT02260388 , registered on 6 October 2014. [ABSTRACT FROM AUTHOR]

Stigma of mental illness contributes to silence, denial and delayed help seeking. Existing stigma reduction strategies seldom consider gender and cultural contexts. The Strengths in Unity study was a multi-site Canadian study that engaged Asian men in three stigma reduction interventions (ACT, CEE, psychoeducation) and mobilized them as Community Mental Health Ambassadors. Our participants included both men living with or affected by mental illness (LWA) as well as community leaders (CL). This paper will: (1) describe the baseline characteristics of the Toronto participants including their sociodemographic information, mental illness stigma (CAMI and ISMI), attitudes towards social change (SJS), and intervention-related process variables (AAQ-II, VLQ, FMI, Empowerment); (2) compare the differences among these variables between LWA and CL; and (3) explore factors that may correlate with socio-economic status and mental health stigma. A total of 609 Asian men were recruited in Toronto, Canada. Both CL and LWA had similar scores on measures of external and internalized stigma and social change attitudes, except that LWA had more positive views about the acceptance and integration of those with mental illness into the community on the CAMI, while CL had a higher level of perceived behavioral control on the SJS. Group differences were also observed between LWA and CL in some process-related variables. Exploratory analysis suggests that younger and more educated participants had lower stigma. Our findings underscore the importance of engaging both community leaders and people with lived experience as mental health advocates to address stigma. [ABSTRACT FROM AUTHOR]

Background: Melanoma incidence has quadrupled since 1970 and melanoma is now the second most common cancer in individuals under 50. Targeted immunotherapies for melanoma now potentially enable long-term remission even in advanced melanoma, but these melanoma survivors require ongoing surveillance, with implications for NHS resources and significant social and psychological consequences for patients. Total skin self-examination (TSSE) can detect recurrence earlier and improve clinical outcomes but is underperformed in the UK. To support survivors, the Achieving Self-directed Integrated Cancer Aftercare (ASICA) intervention was developed to prompt and improve TSSE performance, with subsequent reporting of concerns and submission of skin photos to a Dermatology Nurse Practitioner (DNP). ASICA was delivered as a randomized pilot trial.Methods: This paper reports on process evaluation. Data on participants' demographics and the concerns they reported during the trial were tabulated and displayed using Microsoft Excel and SPSS. We explored which participants used ASICA, and how frequently, to report any skin concerns. We also determined how the interactions had worked in terms of quality of skin photographs submitted, clinical assessments made by the DNP, and the assessments and decisions made for each concern. Finally, we explored significant events occurring during the trial. Data on participants' demographics and the concerns they reported during the trial were tabulated and displayed using SPSS. A semi-structured interview was undertaken with the DNP to gain perspective on the range of concerns presented and how they were resolved.Results: Of 121 recruited melanoma patients receiving ASICA for 12 months, 69 participants submitted a total of 123 reports detailing 189 separate skin-related concerns and including 188 skin photographs. Where participants fully complied with follow-up by the DNP, concerns were usually resolved remotely, but 19 (10.1%) were seen at a secondary care clinic and 14 (7.4%) referred to their GP. 49 (25.9%) of concerns were not completely resolved due to partial non-compliance with DNP follow-up.Conclusion: Melanoma patients randomized to the ASICA intervention were able to report skin-related concerns that could be resolved remotely through interaction with a DNP. Feasibility issues highlighted by ASICA will support further development and optimization of this digital tool.Trial Registration: Clinical Trials.gov , NCT03328247 . Registered on 1 November 2017. [ABSTRACT FROM AUTHOR]

Purpose: Age, sex, and type of fracture have traditionally been described as prognostic factors for proximal humeral fractures (PHFs). Some non-medical patient-related factors may play a role in the outcome. This paper evaluates the association of comorbidities and socioeconomic factors with clinical outcomes for PHF.Methods: A total of 217 patients with PHF were evaluated according to Neer's classification with X-ray. Comorbidities were assessed through the Charlson comorbidity index and, non-medical patient-related factors were determined with a 52-item questionnaire concerning personal behaviors such as social activities, family support, economic solvency, and leisure-time activities. The clinical outcome was assessed with the Constant-Murley Score (CMS), with a minimum 1-year follow-up. The minimal clinically relevant difference for the CMS was set at 10 points. A multivariable analysis was performed to adjust for comorbidities and non-medical patient-related factors, such as age, sex, fracture classification, and treatment.Results: One hundred and eighty-three patients completed the initial research protocol, while 126 of them completed the 1-year follow-up. The mean age was 71.6 years (SD ± 13.3), and 79.3% of the patients were women. In the bivariable analysis, age and comorbidities were correlated with the CMS (correlation coefficient: - 0.34 [- 0.49, 0.17] and 0.35 [0.18, 0.50], respectively), as well as non-medical patient-related factors and the fracture pattern (p value ANOVA < 0.001). In the multivariable regression model, the effects of considering oneself socially active, without economic problems, and self-sufficient were associated with a higher CMS than the effect of the fracture pattern (beta coefficient: 11.69 [6.09-17.30], 15.54 [8.32-22.75], and 10.61 [3.34-17.88], respectively).Conclusion: Socioeconomic status had a higher impact on functional outcomes than fracture pattern in patients with PHF. [ABSTRACT FROM AUTHOR]

Background - Histoplasmosis is a soil based rare air borne fungal infection and mostly documented in HIV positive patients. They are common in people living near valley region. Materials and methods- This is a multiinstitutional study. We report 3 cases of asian women from different regions of Southern Rajasthan who died due to delayed diagnosis of Histoplasmosiswithin few days of admission. They all had complaints of fatigue and fever since 1 month. One presented with decreased urine output and pancytopenia. Others had complaints of prolonged fever with pancytopenia and fatigue. All were diagnosed on Bone marrow examination for presence of Histoplasma Capsulatum, diagnosis was supported by special stains used for reporting. Treatment was started but patients deteriorated and died within 10 days of admission. Conclusion- Delay in diagnosis of Histoplasmosis leads to death of patients. So, Histoplasmosis is considered as a differential diagnosis of prolonged fever with pancytopenia and chronic infections. [ABSTRACT FROM AUTHOR]

Background: Impaired physical function due to chemotherapy-induced peripheral neuropathy (CIPN) symptoms may lead to diminished quality of life. However, even with the knowledge of the effects of CIPN on physical function, clinicians infrequently assess and manage CIPN. Interventions that prioritize the early identification of CIPN to provide prompt treatment may reduce the impact of CIPN on physical function. The purpose of this paper is to compare self-reported physical function in individuals receiving neurotoxic chemotherapy between Electronic Symptom Assessment-Cancer (ESRA-C) intervention group (e.g., opportunity for symptom screening, self-care recommendations, communication coaching, and symptom tracking) and control group participants (i.e., electronic assessment alone). Secondary outcomes include pain intensity, sensory/motor CIPN, depression, fatigue, and insomnia.Methods: The data used in this paper are a subset of a randomized controlled trial that examined the impact of the ESRA-C intervention on symptom distress in individuals receiving cancer treatment. Since the interest in this analysis is on the effects of neurotoxic chemotherapy on physical function, subjects were included if they received platinum and/or taxane-based chemotherapy and completed the baseline and end-of-treatment measures. Participants completed standardized questionnaires of physical function, CIPN, fatigue, depression, pain intensity, and insomnia prior to treatment, 3-6 weeks after treatment initiation, and after the completion of treatment. Changes in mean scores are compared between groups using linear mixed models adjusting for age.Results: Intervention group participants reported significantly less reduction in physical functioning (baseline: 87.4/100; end-of-treatment: 84.5/100) relative to the control (baseline: 90.2/100; end-of-treatment: 81.8/100) (p = 0.011). For secondary measures, significantly less depression (p = 0.005) was observed in the intervention group as compared to the control, but otherwise, there were no between-group differences. Among participants who received high cumulative doses of neurotoxic chemotherapy, the intervention group reported significantly less severe sensory (p = 0.007) and motor CIPN (p = 0.039) relative to the control.Conclusion: Use of the ESRA-C intervention led to less reduction in physical function in comparison to the control in individuals receiving neurotoxic chemotherapy. Further research is needed to confirm our findings and to identify how electronic symptom assessment technology may mediate physical function preservation.Trial Registration: ClinicalTrials.Gov NCT00852852 . Registered 27 February 2009. [ABSTRACT FROM AUTHOR]

Background: Misophonia is a condition marked by dysregulated emotions and behaviors in response to trigger sounds, often chewing, breathing, or coughing. Evidence suggests that misophonia develops in adolescence and the emotions and behaviors are a conditioned response to distress, resulting in social avoidance, stress, and family conflict. In addition, co-occurrence with other psychiatric illnesses such as anxiety, OCD, and Tourette syndrome is common. A transdiagnostic cognitive behavioral therapeutic (CBT) approach appears appropriate. There are currently no controlled studies of youth with misophonia. The current paper describes the approach to a pilot randomized, blinded family-based treatment study for youth ages 8-16 years. Preliminary results from a pilot open trial also are described.Methods: A 2-phase dual site telehealth treatment study using a transdiagnostic CBT approach, the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A; Ehrenreich-May et al., 2018), is proposed. Phase 1 consisted of a 4-case pilot of UP-C/A. Phase 2 includes a randomized trial comparing the UP-C/A to a standard relaxation and education protocol.Results: Preliminary results from the pilot show modest improvements in evaluator-rated misophonia symptoms on the Clinical Global Impression Severity and Improvement scales.Limitations: There is little research to inform evidence-based practice for youth with misophonia. Study limitations include lack of standardized misophonia assessment instruments and an absence of formal diagnostic criteria.Conclusions: The current paper describes proposed methods for the first randomized controlled trial for youth with misophonia and their families along with results from a 4-case pilot. [ABSTRACT FROM AUTHOR]

Background: Core outcome sets (COS) help to minimise bias in trials and facilitate evidence synthesis. Delphi surveys are increasingly being used as part of a wider process to reach consensus about what outcomes should be included in a COS. Qualitative research can be used to inform the development of Delphi surveys. This is an advance in the field of COS development and one which is potentially valuable; however, little guidance exists for COS developers on how best to use qualitative methods and what the challenges are. This paper aims to provide early guidance on the potential role and contribution of qualitative research in this area. We hope the ideas we present will be challenged, critiqued and built upon by others exploring the role of qualitative research in COS development. This paper draws upon the experiences of using qualitative methods in the pre-Delphi stage of the development of three different COS. Using these studies as examples, we identify some of the ways that qualitative research might contribute to COS development, the challenges in using such methods and areas where future research is required.Results: Qualitative research can help to identify what outcomes are important to stakeholders; facilitate understanding of why some outcomes may be more important than others, determine the scope of outcomes; identify appropriate language for use in the Delphi survey and inform comparisons between stakeholder data and other sources, such as systematic reviews. Developers need to consider a number of methodological points when using qualitative research: specifically, which stakeholders to involve, how to sample participants, which data collection methods are most appropriate, how to consider outcomes with stakeholders and how to analyse these data. A number of areas for future research are identified.Conclusions: Qualitative research has the potential to increase the research community's confidence in COS, although this will be dependent upon using rigorous and appropriate methodology. We have begun to identify some issues for COS developers to consider in using qualitative methods to inform the development of Delphi surveys in this article. [ABSTRACT FROM AUTHOR]

Aims and objectives: Investigate evidence available on the efficacy, safety and acceptability of devices for the management of female urinary incontinence, in which clinical settings and specific female populations they have been tested. Learn more about healthcare professionals' perspectives and experiences regarding female urinary incontinence devices. Background: Urinary incontinence is defined as the involuntary leakage of urine, estimated to affect 25%–45% of women. Urinary incontinence predisposes the skin to urinary incontinence dermatitis, it is one of the most common documented causes of inappropriate urinary catheterisation, favouring catheter‐associated infection. Several products for managing female urinary incontinence are available, no accurate and systematic data on usability, effectiveness and associated outcomes of these products are available. Design and Methods: A scoping review was conducted, using a methodological framework including the following five steps: identification of the research question; identification of relevant documents; selection of documents included in the review; tracking of information and data; synthesis and reporting of results. Twenty‐one articles were selected. PRISMA‐ScR Checklist was followed. Results: The devices explored in the studies were as follows: female external urinary catheter; disposable sanitary pads, diapers or sanitary pads used to manage urinary incontinence in women; mechanical devices; a new prototype of underwear that tracks where pads lose; reusable underwear for light incontinence; a new intelligent system pad. Conclusions: New smart pads, urine suction systems and female external catheters appear to be effective in preventing and reducing urinary incontinence dermatitis. The female external catheter reduces the days of indwelling catheterisation and could reduce the incidence of catheter associated urinary tract infection; therefore, it should be recommended. [ABSTRACT FROM AUTHOR]