Optic disc morphology and interocular symmetry in children.

PURPOSE: The purpose of the study was to obtain a pediatric reference database for optic disc parameters and interocular symmetry. To ascertain factors that modify these parameters (age, spherical equivalent [SE], and sex). METHODS: This was a cross-sectional study. 90 patients aged 5-17 years fulfilled all the inclusion criteria. After a full examination including cycloplegic refraction, all patients underwent optical coherence tomography (OCT) of the papilla using the three-dimensional (3D) scan protocol of the Topcon 3D 2000 OCT device. We provide reference values for optic disc parameters in the pediatric population. We also retrieved interocular symmetry reference values for these parameters. RESULTS: The multivariate regression analysis did not reveal variations in any of the optic disc parameters associated with age, sex, or SE (all P ≥ 0.126). The 95th percentile limit for absolute interocular differences for the cup-to-disc area ratio was 0.24. The multivariate regression analysis revealed the absence of a correlation between asymmetry of the optic disc parameters and age, sex, and the interocular difference in SE (all P ≥ 0.105). CONCLUSION: Pediatric reference databases for optic disc parameters and ranges of normality for interocular symmetry provide key diagnostic support in diseases that affect the optic nerve.

Assessing the Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity: Randomized Controlled Trial.

BACKGROUND: Virtual reality (VR) interventions, based on cognitive behavioral therapy principles, have been proven effective as complementary tools in managing obesity and have been associated with promoting healthy behaviors and addressing body image concerns. However, they have not fully addressed certain underlying causes of obesity, such as a lack of motivation to change, low self-efficacy, and the impact of weight stigma interiorization, which often impede treatment adherence and long-term lifestyle habit changes. To tackle these concerns, this study introduces the VR self-counseling paradigm, which incorporates embodiment and body-swapping techniques, along with motivational strategies, to help people living with obesity effectively address some of the root causes of their condition. OBJECTIVE: This study aims to assess the clinical efficacy of ConVRself (Virtual Reality self-talk), a VR platform that allows participants to engage in motivational self-conversations. METHODS: A randomized controlled trial was conducted with 68 participants from the bariatric surgery waiting list from the obesity unit of the Vall d'Hebron University Hospital in Barcelona, Spain. Participants were assigned to 1 of 3 groups: a control group (CG), which only received treatment as usual from the obesity unit; experimental group 1 (EG1), which, after intensive motivational interviewing training, engaged in 4 sessions of VR-based self-conversations with ConVRself, and underwent embodiment and body-swapping techniques; and experimental group 2 (EG2), which engaged in 4 VR-based sessions led by a virtual counselor with a prerecorded discourse, and only underwent the embodiment technique. In the case of both EG1 and EG2, the VR interventions were assisted by a clinical researcher. Readiness to change habits, eating habits, and psychological variables, as well as adherence and satisfaction with ConVRself were measured at baseline, after the intervention, 1 week after the intervention, and 4 weeks after the intervention. RESULTS: Regarding the primary outcomes, EG1 (24/68, 35%) and EG2 (22/68, 32%) showed significant improvements in confidence to lose weight compared to the CG (22/68, 32%) at all assessment points (ß=-.16; P=.02). Similarly, EG1 demonstrated a significant increase after the intervention in readiness to exercise more compared to the CG (ß=-.17; P=.03). Regarding the secondary outcomes, EG1 participants showed a significant reduction in uncontrolled eating (ß=.71; P=.01) and emotional eating (ß=.29; P=.03) compared to the CG participants, as well as in their anxiety levels compared to EG2 and CG participants (ß=.65; P=.01). In addition, participants from the experimental groups reported high adherence and satisfaction with the VR platform (EG1: mean 59.82, SD 4.00; EG2: mean 58.43, SD 5.22; d=0.30, 95% CI -0.30 to 0.89). CONCLUSIONS: This study revealed that using VR self-conversations, based on motivational interviewing principles, may have benefits in helping people with obesity to enhance their readiness to change habits and self-efficacy, as well as reduce dysfunctional eating behaviors and anxiety. TRIAL REGISTRATION: ClinicalTrials.gov NCT05094557; https://www.clinicaltrials.gov/study/NCT05094557.

Biofeedback and Digitalized Motivational Interviewing to Increase Daily Physical Activity: Series of Factorial N-of-1 Randomized Controlled Trials Piloting the Precious App.

BACKGROUND: Insufficient physical activity is a public health concern. New technologies may improve physical activity levels and enable the identification of its predictors with high accuracy. The Precious smartphone app was developed to investigate the effect of specific modular intervention elements on physical activity and examine theory-based predictors within individuals. OBJECTIVE: This study pilot-tested a fully automated factorial N-of-1 randomized controlled trial (RCT) with the Precious app and examined whether digitalized motivational interviewing (dMI) and heart rate variability-based biofeedback features increased objectively recorded steps. The secondary aim was to assess whether daily self-efficacy and motivation predicted within-person variability in daily steps. METHODS: In total, 15 adults recruited from newspaper advertisements participated in a 40-day factorial N-of-1 RCT. They installed 2 study apps on their phones: one to receive intervention elements and one to collect ecological momentary assessment (EMA) data on self-efficacy, motivation, perceived barriers, pain, and illness. Steps were tracked using Xiaomi Mi Band activity bracelets. The factorial design included seven 2-day biofeedback interventions with a Firstbeat Bodyguard 2 (Firstbeat Technologies Ltd) heart rate variability sensor, seven 2-day dMI interventions, a wash-out day after each intervention, and 11 control days. EMA questions were sent twice per day. The effects of self-efficacy, motivation, and the interventions on subsequent steps were analyzed using within-person dynamic regression models and aggregated data using longitudinal multilevel modeling (level 1: daily observations; level 2: participants). The analyses were adjusted for covariates (ie, within- and between-person perceived barriers, pain or illness, time trends, and recurring events). RESULTS: All participants completed the study, and adherence to activity bracelets and EMA measurements was high. The implementation of the factorial design was successful, with the dMI features used, on average, 5.1 (SD 1.0) times of the 7 available interventions. Biofeedback interventions were used, on average, 5.7 (SD 1.4) times out of 7, although 3 participants used this feature a day later than suggested and 1 did not use it at all. Neither within- nor between-person analyses revealed significant intervention effects on step counts. Self-efficacy predicted steps in 27% (4/15) of the participants. Motivation predicted steps in 20% (3/15) of the participants. Aggregated data showed significant group-level effects of day-level self-efficacy (B=0.462; P<.001), motivation (B=0.390; P<.001), and pain or illness (B=-1524; P<.001) on daily steps. CONCLUSIONS: The automated factorial N-of-1 trial with the Precious app was mostly feasible and acceptable, especially the automated delivery of the dMI components, whereas self-conducted biofeedback measurements were more difficult to time correctly. The findings suggest that changes in self-efficacy and motivation may have same-day effects on physical activity, but the effects vary across individuals. This study provides recommendations based on the lessons learned on the implementation of factorial N-of-1 RCTs.

Virtual self-conversation using motivational interviewing techniques to promote healthy eating and physical activity: A usability study.

Introduction: We aim to examine the usability of a Virtual Reality (VR) platform, called ConVRSelf, which has been designed to address the needs of People Living With Obesity (PLWO). Methods: Fourteen participants with a desire to eat healthier and exercise more (6 normal weight and 8 PLWO; Mean age = 41.86, SD = 13.89) were assigned to the experimental group (EG) or the control group (CG). EG participants, after being trained on motivational interviewing skills, engaged in a virtual self-conversation using embodiment and body swapping techniques, which aimed to normalize and resolve their ambivalence to change lifestyle habits. CG participants, embodied in their virtual bodies, participated in a pre-established discourse with a virtual counselor giving them psychoeducational advice about how to change lifestyle habits. A mixed-methods design was used, involving a semi-structured interview and self-report questionnaires, including readiness to change habits (Readiness Rulers), body ownership (Body Ownership Questionnaire, BOQ), and system usability (System Evaluation Questionnaire, SEQ). Thematic content analysis was carried out for qualitative data while statistical data analysis was carried out using SPSS 20.0. Results: Participants from both groups showed high readiness to change lifestyle (Readiness Rulers) before engaging with the virtual experiences, which was maintained at the same level after the interventions and their scores on the SEQ and BOQ were satisfactory. Regarding qualitative information obtained from the interviews, almost all participants found the VR experience to be novel, interesting, and enjoyable. A higher acceptability was observed among PLWO from the EG than normal weight participants from the same group, a promising finding for the ConVRSelf platform, which had been specifically designed to address the needs of PLWO. Conclusion: The ConVRSelf system is well-accepted by participants and is ready to be tested with PLWO in a clinical setting.

Alternative forms of portal vein revascularization in liver transplant recipients with complex portal vein thrombosis.

BACKGROUND & AIMS: Complex portal vein thrombosis (PVT) is a challenge in liver transplantation (LT). Extra-anatomical approaches to portal revascularization, including renoportal (RPA), left gastric vein (LGA), pericholedochal vein (PCA), and cavoportal (CPA) anastomoses, have been described in case reports and series. The RP4LT Collaborative was created to record cases of alternative portal revascularization performed for complex PVT. METHODS: An international, observational web registry was launched in 2020. Cases of complex PVT undergoing first LT performed with RPA, LGA, PCA, or CPA were recorded and updated through 12/2021. RESULTS: A total of 140 cases were available for analysis: 74 RPA, 18 LGA, 20 PCA, and 28 CPA. Transplants were primarily performed with whole livers (98%) in recipients with median (IQR) age 58 (49-63) years, model for end-stage liver disease score 17 (14-24), and cold ischemia 431 (360-505) minutes. Post-operatively, 49% of recipients developed acute kidney injury, 16% diuretic-responsive ascites, 9% refractory ascites (29% with CPA, p <0.001), and 10% variceal hemorrhage (25% with CPA, p = 0.002). After a median follow-up of 22 (4-67) months, patient and graft 1-/3-/5-year survival rates were 71/67/61% and 69/63/57%, respectively. On multivariate Cox proportional hazards analysis, the only factor significantly and independently associated with all-cause graft loss was non-physiological portal vein reconstruction in which all graft portal inflow arose from recipient systemic circulation (hazard ratio 6.639, 95% CI 2.159-20.422, p = 0.001). CONCLUSIONS: Alternative forms of portal vein anastomosis achieving physiological portal inflow (i.e., at least some recipient splanchnic blood flow reaching transplant graft) offer acceptable post-transplant results in LT candidates with complex PVT. On the contrary, non-physiological portal vein anastomoses fail to resolve portal hypertension and should not be performed. IMPACT AND IMPLICATIONS: Complex portal vein thrombosis (PVT) is a challenge in liver transplantation. Results of this international, multicenter analysis may be used to guide clinical decisions in transplant candidates with complex PVT. Extra-anatomical portal vein anastomoses that allow for at least some recipient splanchnic blood flow to the transplant allograft offer acceptable results. On the other hand, anastomoses that deliver only systemic blood flow to the allograft fail to resolve portal hypertension and should not be performed.

Alström syndrome: Two clinical cases with two novel pathogenic variants.

PURPOSE: To report two clinical cases of Alström syndrome (AS) with novel pathogenic variant of the ALMS1 gene not previously reported. CASE DESCRIPTION: Patient 1 was a 6-year-old female presenting with poor vision. Ophthalmic examination only showed a visual field (VF) with diffusely decreased sensitivity in both eyes. At age of 15, vision and ophthalmic examination remain stable. Patient 2 was a 2-year-old male with poor vision, photophobia, and nystagmus. ERG showed a severe decrease in cone and rod responses. At age of 6, his vision is lower than 0.1 (decimal scale) and VF is severely constricted. Both of them presented with dilated cardiomyopathy in their first's months of life and patient 2 developed sensorineural deafness along with follow-up. Research genetic testing revealed two loss-of-function heterozygous genetic variants in the ALMS1 gene in both patients, so the diagnosis of AS was made. CONCLUSIONS: AS is a rare disease caused by pathogenic variants of ALMS1 gene that causes ocular manifestations in almost 100% of patients. There are many genetic variants of AMLS1 described, but novel pathogenic variants can still be found. Ophthalmologists play an important role in the diagnosis, and AS should be included in the differential diagnosis when retinal dystrophy is suspected.

Macular thickness variation and interocular symmetry by gestational age in preterm school-age children.

PURPOSE: To determine changes in macular thickness profile according to gestational age (GA) and to assess interocular symmetry in the macula of children born very preterm. METHODS: In this cross-sectional study of preterm (n = 106) and term-born (n = 49) children 5-8 years of age at time of examination, optical coherence tomography was used to measure macula thickness as described in the ETDRS study. Statistical analyses included stratified and multivariable analyses. RESULTS: Foveal minimum thickness increased with decreasing GA (P for trend, <0.001; 254.7 ± 32.8 µm for children born at 24-25 weeks and 193.2 ± 32.8 µm in term-born children). Inner and outer area thickness differed for term and preterm children, but did not vary with the degree of prematurity (inner area, 267.0 ± 11.0 µm for 24-25 weeks' GA and 305.4 ± 11.8 µm for term children [P < 0.01]; outer ring, 305.5 ± 10.4 µm in extreme preterm and 271.0 ± 10.4 µm in term children [P < 0.01]). Interocular asymmetry in preterm children was not significant for most areas; the largest interocular difference was found in the central zone (16.3 ±16.6 µm). CONCLUSIONS: In our study cohort, children born very preterm examined at school age compared to term born children had greater central thickness with decreased foveal pit, decreased inner ring, and increased thickness of the outer ring. They did not show greater interocular asymmetry.

Clinical efficacy of a virtual reality tool for the treatment of obesity: study protocol of a randomised controlled trial.

INTRODUCTION: Previous research has shown that it is feasible to integrate motivational interviewing techniques with behavioural and psychological interventions for the treatment of obesity. Moreover, these combined interventions have the potential to improve health-related outcomes of people living with obesity (PLWO) and to afford maintenance of behavioural changes over time. In addition, the use of virtual reality (VR) embodiment techniques in the treatment of eating disorders and obesity has promising preliminary effectiveness. The objective of this study is to assess the clinical efficacy of a VR intervention that uses embodiment and body-swapping techniques and has been specifically developed to cover the needs of PLWO. METHODS AND ANALYSIS: A randomised control trial will be carried out with an estimated sample of 96 participants with body mass index (BMI)>30. The whole duration of the trial will be 12 months. Participants will be recruited from the external consultations of the Vall d'Hebron University Hospital and be randomly assigned to three groups. The experimental group 1 will engage in a virtual self-conversation using the ConVRself platform, the experimental group 2 will participate in a 'pre-established discourse' provided by the virtual counsellor, who will give psychoeducation advice, and the control group will continue with treatment as usual. Readiness to change, BMI, eating habits and physical activity, psychological well-being, body image satisfaction, quality of life in relation to body image, and weight bias internalisation will be assessed at baseline, post intervention, 1-week and 4-week follow-up. Finally, variables related to adherence and satisfaction with the VR tool will be evaluated for the experimental groups. ETHICS AND DISSEMINATION: This study was approved by the Research Projects Committee of the Vall d'Hebron University Hospital. Findings will be disseminated through peer-reviewed journals, reports to the funding body, conferences and other events for the scientific and clinical community, and the general public. TRIAL REGISTRATION NUMBER: NCT05094557.

Retinal ganglion cell complex thickness at school-age, prematurity and neonatal stressors.

PURPOSE: To investigate the association between the ganglion cell complex (GCC) thickness at early school-age and prematurity and other neonatal factors. METHODS: Cross-sectional study. The sample included very preterm children with gestational age (GA) below 32 weeks or birthweight below 1500 g enrolled in a follow-up program (n = 101) and a comparison group of term-born children (n = 49). Ganglion cell complex (GCC) thickness was measured at 4-8 years using high-quality optical coherence tomography (OCT) images. Data on neonatal and postnatal features were extracted from clinical records; analyses included mixed linear models. RESULTS: Ganglion cell layer (GCL) and retinal nerve fiber layer (mRNFL) were thicker in term than in preterm born children (2.9 µm and 2.4 µm respectively, p < 0.001). Within the preterm group, lower GA was associated with a decrease in total GCL (0.7 µm per week, p < 0.001). Being small for GA was associated with further thinning in both layers (1.4 and 2.8 µm). Postnatal corticosteroids therapy and severe brain lesion were associated with thinning in the total GCL of 6 µm (p < 0.001) and 4.1 µm (p = 0.002), respectively, and shock was associated with thinning in total mRNFL of 6 µm (p < 0.001). CONCLUSIONS: Lower GA or birthweight are associated with thinning of GCC layers. When performing an OCT examination at school-age and a decrease in GCC thickness is observed, it may be relevant to ask about a history of prematurity, and further enquire about neonatal shock, postnatal corticosteroids therapy or severe brain lesion that are related to additional decrease in GCC thickness.

Contribution of Optical Coherence Tomography to the Diagnosis of Childhood-Onset Stargardt Disease in Its Early Stages.

Stargardt disease may present with alterations in optical coherence tomography before symptoms and fundus abnormalities appear. With this non-invasive test, a presumptive diagnosis can be made and genetically confirmed in the subclinical stages of the disease. [J Pediatr Ophthalmol Strabismus. 2021;58(3):e5-e8.].

Measurement of macular thickness with optical coherence tomography: impact of using a paediatric reference database and analysis of interocular symmetry.

PURPOSE: Optical coherence tomography (OCT) software is used to classify abnormality of macular thickness by colour category based on reference data from adult series. We assessed the impact of using paediatric reference thickness values for macular thickness instead of adult reference values. METHODS: Cross-sectional study. Primary and tertiary healthcare setting. Out of 140 healthy participants aged 5 to 18 years, 126 were eligible, 83% from European origin. Following a dilated eye examination and cycloplegic refraction, participants underwent macular scanning with OCT (Topcon 3D OCT-2000). Macular thickness paediatric reference values were recorded by spherical equivalent (SE) and sex, and the specific agreement between paediatric and adult reference values below or equal to percentile 5 and above percentile 95 was estimated. The absolute interocular differences for all macular parameters were determined. RESULTS: Multivariate regression analysis confirmed statistically independent positive associations between SE and average thickness, total volume, and temporal and inferior outer quadrants (all p values ≤ 0.003). The analysis also revealed higher values in males for average thickness, central thickness, and all inner macula quadrants (all p values ≤ 0.039). The use of the adult database only detected 49% of the extreme values (≤ p5 and > p95) in our paediatric sample. The 95th percentile limits for absolute interocular differences for all macular parameters ranged from 12 to 17 µm. CONCLUSIONS: OCT-based macular reference values for paediatric SE and sex improve detection of children with abnormal macular thicknesses. Interocular differences exceeding standard references for macular parameters should be considered for further examinations.

IMAGINE study protocol of a clinical trial: a multi-center, investigator-blinded, randomized, 36-month, parallel-group to compare the effectiveness of motivational interview in rehabilitation of older stroke survivors.

BACKGROUND: Rehabilitation pathways are crucial to reduce stroke-related disability. Motivational Interviewing (MI), as a person-centered complex intervention, aimed to empower and motivate, and could be a resource to improve rehabilitation outcomes for older stroke survivors. The IMAGINE project aims to assess the impact of MI, as a complement to standard geriatric rehabilitation, on functional improvement at 30 days after admission, compared to standard geriatric rehabilitation alone, in persons admitted to geriatric rehabilitation after a stroke. Secondary objectives include assessing the impact of MI on physical activity and performance, self-efficacy, safety, cost-utility, participants' experiences and functional status at 3 months. METHODS: We will conduct a multicenter randomized clinical trial in three geriatric rehabilitation hospitals in Spain. Older adults after mild-moderate stroke without previous severe cognitive impairment or disability will be randomized into the control or intervention group (136 per group, total N = 272). The intervention group will receive 4 sessions of MI by trained nurses, including the design of a personalized rehabilitation plan agreed between stroke survivors and nurses based on stroke survivors´ goals, needs, preferences and capabilities. Main outcome will be the Functional Independence Measure (FIM). In-hospital physical activity will be measured through accelerometers and secondary outcomes using validated scales. The study includes a process evaluation and cost-utility analysis. DISCUSSION: Final results are expected by end of 2020. This study will provide relevant information on the implementation of MI as a rehabilitation reinforcement tool in older stroke survivors. A potential reduction in post-stroke disability and dependence would increase person's health-related quality of life and well-being and reduce health and social care costs. IMAGINE has the potential to inform practice and policymakers on how to move forward towards shared decision-making and shared responsibilities in the vulnerable population of older stroke survivors. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03434938 , registered on January 2018.

Assessing the user experience and usability of the PRECIOUS system: a randomized controlled trial in obese patients.

Objective To assess users' usability, satisfaction, acceptance and effectiveness of the PRECIOUS system to promote behavior change toward healthier lifestyles. Design: Thirty-one adult patients with BMI>30 (M = 44.23, SD = 5.91) were recruited and randomized into three conditions for a longitudinal study (3 months length): 1) Control group (TAU + biofeedback + follow-ups); 2) PRECIOUS only (app + biofeedback + follow-ups); 3) PRECIOUS + MI (app + biofeedback + motivational interviewing follow-ups). Main Outcome Measures: Usability, satisfaction, acceptance and effectiveness of PRECIOUS, and stages of change (S-Weight questionnaire). Results: The system was described as easy to use, flexible, fairly satisfying and good as a preventive health system. Participants rated biofeedback and the Physical Activity module as the most satisfying features. However, participants were unsatisfied with the Diet module. All additional features received acceptable scores in terms of satisfaction. Despite this, the PRECIOUS only group reported that they would probably recommend the system to others because it meets its purposes quite well. Conclusion: PRECIOUS was found a usable and acceptable solution, although improving several features in the Diet module in successive versions of the app would promote sustained use and satisfaction among users, possibly increasing its effectiveness in promoting healthier lifestyles. Abbreviations: ADA American Diabetes Association; BG2: BodyGuard2; BMI: Body Mass Index; CBT: Cognitive-behavioral therapy; EMA: Ecological Momentary Assessment; eHealth: Electronic health; mHealth: Mobile health; MI: Motivational interviewing; NCD: Non-communicable diseases; PA: Physical activity; PRECIOUS: PREventive Care Infrastructure based On Ubiquitous Sensing.