Feasibility Outcomes Research Articles

Feasibility of a novel eHealth intervention for Parkinson’s disease targeting motor-cognitive function in the home

BackgroundParkinson’s disease (PD) drastically affects motor and cognitive function, but evidence shows that motor-cognitive training improves disease symptoms. Motor-cognitive training in the home is scarcely investigated and eHealth methods can provide continual support for PD self-management. Feasibility testing is however required.ObjectiveTo assess the feasibility (i) Recruitment capability (ii) Acceptability and Suitability (iii) Demand and Safety of a home-based motor-cognitive eHealth exercise intervention in PD.MethodsThe 10-week intervention was delivered using the ExorLive® application and exercises were individually adapted and systematically progressed and targeted functional strength, cardiovascular fitness, flexibility, and motor-cognitive function. People with mild-to moderate PD were assessed before and after the intervention regarding; gait performance in single and dual-task conditions; functional mobility; dual-task performance; balance performance; physical activity level; health related quality of life and perceived balance confidence and walking ability; global cognition and executive function. Feasibility outcomes were continuously measured using a home-exercise diary and contact with a physiotherapist. Changes from pre- and post-intervention are reported descriptively.ResultsFifteen participants (mean age 68.5 years) commenced and 14 completed the 10-week intervention. In relation to intervention Acceptability, 64% of the motor sessions and 52% of motor-cognitive sessions were rated as “enjoyable”. Concerning Suitability, the average level of exertion (Borg RPE scale) was light (11–12). Adherence was high, with 86% of all (420) sessions reported as completed. No falls or other adverse events occurred in conjunction with the intervention.ConclusionsThis motor-cognitive eHealth home exercise intervention for PD was safe and feasible in terms of Recruitment capability, Acceptability, Safety and Demand. The intensity of physical challenge needs to be increased before testing in an efficacy trial.Trial registrationThis trial is registered at Clinicaltrials.gov (NCT05027620).

Endovascular revascularization of vertebrobasilar tandem occlusions in comparison to isolated basilar artery occlusions: A multi-center experience.

Acute basilar artery occlusion (BAO) is a severe disease that is associated with an 85% mortality rate if untreated. Several studies have analyzed the use of mechanical thrombectomy (MT) in the different scenarios of BAO. However, the results remain conflicting and the role of MT as standard of care for vertebrobasilar tandem occlusions (VBTO) has not been confirmed. Our goal was to assess technical feasibility, safety, and functional outcome of endovascular treatment of VBTO in comparison to isolated BAO (IBAO). We retrospectively reviewed all prospectively collected patients with acute BAO from six tertiary centers between September 2016 and November 2021. Patients were subsequently divided into two groups: VBTO and IBAO. Baseline data, procedural details, and outcomes were compared between groups. A total of 190 patients were included, 55 presenting with a VBTO and 135 with IBAO. Successful recanalization was equally common in both groups (89.1% and 86.0%). Rates of favorable functional outcome (modified Rankin Scale: 0-2) were higher in patients with VBTO compared to IBAO (36.4% vs. 25.2%, p = 0.048) and mortality was lower (29.1% vs. 33.3%). However, these associations faded after adjustment for confounders (adjusted odds ratio [aOR] 0.86, 95% CI 0.35-2.05; aOR 0.93, 95% CI 0.35-2.45). Rates of symptomatic intracranial hemorrhage did not differ between the groups (VBTO: 7.3% vs. IBAO: 4.2%; p = 0.496). Endovascular treatment of VBTO is technically feasible and safe with similar rates of successful recanalization, favorable functional outcome, and mortality to those in patients with IBAO.

VNOTES surgical staging for endometrial carcinoma in overweight patients: a case series.

The purpose of this study is to show the feasibility and surgical outcome of vNOTES retroperitoneal dissection and isolation of sentinel lymph nodes in overweight and obese patients with endometrial cancer. Four patients had undergone pelvic lymphadenectomy with a sentinel lymph node. Three patients were overweight, and one was obese with a BMI of 34.6kg/m2. By using NMR mode sentinel lymph node was visualized, excised and marked separately for pathohistological analysis from the rest of the visualized lymph nodes that were then consecutively excised. The mean number of overall excised lymph nodes was 12.5, and the mean number on the right side was 5.75 and 6.25 on the left side. There were no metastases verified in the pathohistological evaluation. vNOTES retroperitoneal isolation of sentinel lymph nodes is good alternative and has its benefits, especially in overweight and obese patients with satisfying low intra- and postoperative complications.

Initial experience of a single surgeon for safety and feasibility of the Versius Robotic System in robot-assisted cholecystectomy and hernia repair.

This study aimed to evaluate the feasibility, safety, and perioperative outcomes of cholecystectomy and hernia repair performed with the Versius Robotic System by a surgeon with no prior robotic surgery experience. A retrospective analysis was conducted on adult patients who underwent cholecystectomy, inguinal, or umbilical hernia repair using the Versius Robotic System between August 2021 and June 2023 et al. Zahra Hospital, Dubai, UAE. A total of 105 patients (mean age 38.9 ± 9.2years) were included. Significant correlations existed between the number of robot-assisted cholecystectomies and the operative metrics. As the number increased, the duration of the total operative (r = -0.755, p < 0.001), docking (r = -0.683, p < 0.001), and console (r = -0.711, p < 0.001) times decreased, indicating improved efficiency with experience. This study demonstrates the safety and feasibility of the Versius Robotic System for cholecystectomy and hernia repair, even for surgeons lacking prior robotic surgery experience.

Evaluating a Remotely Delivered Cardio-Oncology Rehabilitation Intervention for Patients With Breast Cancer (REMOTE-COR-B): Protocol for a Single-Arm Feasibility Trial.

Exercise rehabilitation is a promising strategy for reducing cardiovascular disease risk among patients with breast cancer. However, the evidence is primarily derived from programs based at exercise centers with in-person supervised delivery. Conversely, most patients report a preference for home-based rehabilitation. As such, there is a clear need to explore strategies that can provide real-time supervision and coaching while addressing consumer preferences. Evidence from cardiac rehabilitation has demonstrated the noninferiority of a smartphone-based telerehabilitation approach (REMOTE-CR) to improve cardiorespiratory fitness in people with cardiovascular disease compared to a center-based program. This study aims to assess the feasibility, safety, and preliminary efficacy of the REMOTE-CR program adapted for patients with breast cancer at risk of cardiotoxicity (REMOTE-COR-B). We will also assess the satisfaction and usability of REMOTE-COR-B. We will conduct a single-arm feasibility study of the REMOTE-COR-B program among patients with stage I-III breast cancer who are at risk of cardiotoxicity (taking treatment type and dose, as well as other common cardiovascular disease risk factors into account) and who are within 24 months of completing primary definitive treatment. Participants (target sample size of 40) will receive an 8-week smartphone-based telerehabilitation exercise program involving remotely delivered real-time supervision and behavior change support. The platform comprises a smartphone and wearable heart rate monitor, as well as a custom-built smartphone app and web application. Participants will be able to attend remotely monitored exercise sessions during set operating hours each week, scheduled in both the morning and evening. Adherence is the primary outcome of the trial, assessed through the number of remotely monitored exercise sessions attended compared to the trial target (ie, 3 sessions per week). Secondary outcomes include additional trial feasibility indicators (eg, recruitment and retention), safety, satisfaction, and usability, and objective and patient-reported efficacy outcomes (cardiovascular fitness, quality of life, fatigue, self-reported exercise, self-efficacy, habit strength, and motivation). Adherence, feasibility, and safety outcomes will be assessed during the intervention period; intervention satisfaction and usability will be assessed post intervention; and objective and patient-reported efficacy outcomes will be assessed at baseline, post intervention (2-month postbaseline assessment), and at follow-up (5-month postbaseline assessment). Recruitment for this trial commenced in March 2023, and 7 participants had been recruited as of the submission of the manuscript. The estimated completion date for the project is October 2024, with results expected to be published in mid-2025. The REMOTE-COR-B intervention is a novel and promising approach to providing exercise therapy to patients with breast cancer at risk of cardiotoxicity who have unique needs and heightened safety risks. This project will provide important information on the extent to which this approach is satisfactory to patients with breast cancer, safe, and potentially effective, which is necessary before larger-scale research or clinical projects. Australian New Zealand Clinical Trials Registry ACTRN12621001557820; www.anzctr.org.au/ACTRN12621001557820.aspx. DERR1-10.2196/53301.

Watch Me Play!: protocol for a feasibility study of a remotely delivered intervention to promote mental health resilience for children (ages 0–8) across UK early years and children’s services

BackgroundHalf of mental health problems are established by the age of 14 years and 75% by 24 years. Early intervention and prevention of mental ill health are therefore vitally important. However, increased demand over recent years has meant that access to child mental health services is often restricted to those in severest need. Watch Me Play! (WMP) is an early intervention designed to support caregiver attunement and attention to the child to promote social-emotional well-being and thereby mental health resilience. Originally developed in the context of a local authority mental health service for children in care, it is now also delivered online as a low intensity, scalable, preventative intervention. Although WMP shows promise and is already used in some services, we do not yet know whether it is effective.MethodsA non-randomised single group feasibility study with embedded process evaluation. We propose to recruit up to 40 parents/carers of children aged 0–8 years who have been referred to early years and children’s services in the UK. WMP involves a parent watching the child play and talking to their child about their play (or for babies, observing and following signals) for up to 20 min per session. Some sessions are facilitated by a trained practitioner who provides prompts where necessary, gives feedback, and discusses the child’s play with the caregiver. Services will offer five facilitated sessions, and parents will be asked to do at least 10 additional sessions on their own with their child in a 5-week period. Feasibility outcomes examined are as follows: (i) recruitment, (ii) retention, (iii) adherence, (iv) fidelity of delivery, (v) barriers and facilitators of participation, (vi) intervention acceptability, (vii) description of usual care, and (viii) data collection procedures. Intervention mechanisms will be examined through qualitative interview data. Economic evaluation will be conducted estimating cost of the intervention and cost of service use for child and parents/carers quality-adjusted life years.DiscussionThis study will address feasibility questions associated with progression to a future randomised trial of WMP.Trial registrationISRCTN13644899. Registered on 14th April 2023.

Co-Designed Cardiac Rehabilitation for the Secondary Prevention of Stroke (CARESS): A Pilot Program Evaluation.

Structured health system-based programs, such as cardiac rehabilitation, may reduce the risk of recurrent stroke. This study aimed to co-design and evaluate a structured program of rehabilitation, developed based on insights from focus groups involving stroke survivors and health professionals. Conducted in Tasmania, Australia in 2019, the 7-week program comprised one hour of group exercise and one hour of education each week. Functional capacity (6 min walk test), fatigue, symptoms of depression (Patient Health Questionnaire), and lifestyle were assessed pre- and post-program, with a historical control group for comparison. Propensity score matching determined the average treatment effect (ATE) of the program. Key themes from the co-design focus groups included the need for coordinated care, improved psychosocial management, and including carers and peers in programs. Of the 23 people approached, 10 participants (70% men, mean age 67.4 ± 8.6 years) completed the program without adverse events. ATE analysis revealed improvements in functional capacity (139 m, 95% CI 44, 234) and fatigue (-5 units, 95% CI -9, -1), with a small improvement in symptoms of depression (-0.8 units, 95% CI -1.8, 0.2) compared to controls. The co-designed program demonstrated feasibility, acceptability, and positive outcomes, suggesting its potential to support stroke survivors.

Ultrasound measurement of traumatic scar and skin thickness: a scoping review of evidence across the translational pipeline of research-to-practice

ObjectivesTo identify the ultrasound methods used in the literature to measure traumatic scar thickness, and map gaps in the translation of these methods using evidence across the research-to-practice pipeline.DesignScoping review.Data...

549 A Nationwide Pilot Study Testing a Remotely-Delivered Prolonged Nightly Fasting Intervention in Stressed Midlife Adults Living with Obesity and Memory Decline

OBJECTIVES/GOALS: Cognitive decline is associated with obesity, stress, poor sleep, and circadian rhythm misalignment, which are themselves functionally intertwined. Irregular food intake timing exacerbates these all. Prolonged nightly fasting (PNF) aligns food intake with innate circadian rhythms. METHODS/STUDY POPULATION: A nationwide, remotely-delivered, 2-arm randomized controlled trial was conducted to assess feasibility and 8-week outcomes of cognition, stress, sleep, eating behaviors, and general eating habits, after a PNF intervention (14-hr nightly fast, 6 nights/week, no calories after 8pm) compared to a health education control (HEC) condition. Eligible participants were living with obesity, stress (Perceived stress scale-4 (PSS-4) total score ≥5), and memory “not as good as it used to be.” Data were collected via Zoom meetings with participants and trained staff and entered into REDCap. All participants had weekly staff check-in calls to report fasting times (PNF group only) and feedback. RESULTS/ANTICIPATED RESULTS: Eligible participants were enrolled from 37 of 50 US states; N=58, 86% women, 71% white, 93% non-Latinx, mean (SD) 50.1 (5.1) years of age, BMI 35.6 (3.6) kg/m^2. No group differences existed at baseline. Linear mixed-effects models were used to compare group differences across all outcome changes. Compared to the HEC condition, the PNF intervention was associated with improved sleep quality (Pittsburgh Sleep Quality Index; B = -2.52; SE = 0.90; 95% CI-4.30 to -0.74; p=0.006). Stress, everyday cognition, and emotional eating behavior significantly changed over time (p&lt;0.02), but there were no group differences. Analysis of feasibility outcomes are on-going. DISCUSSION/SIGNIFICANCE: Changing food intake timing 6 days per week, to exclude nighttime eating without mandating food quality/quantity change, may benefit many individuals living with obesity, stress and memory decline to improve their sleep. Improved sleep quality may lead to more health benefits over time.

Hepatopancreaticobiliary Resection Arginine Immunomodulation (PRIMe) trial: protocol for a randomised phase II trial of the impact of perioperative immunomodulation on immune function following resection for hepatopancreaticobiliary malignancy

IntroductionSurgical stress results in immune dysfunction, predisposing patients to infections in the postoperative period and potentially increasing the risk of cancer recurrence. Perioperative immunonutrition with arginine-enhanced diets has been found...

Promoting Healthy Screen Media Use in Young Children With Externalizing Behavior Problems Through an Adapted Parenting Intervention: Results of an Open Trial

In this article, we describe the development of an adapted parenting intervention for caregivers of preschoolers with externalizing behavior problems, which integrates content around screen media use into an existing evidence-based parenting intervention. We also present results of an open trial examining the feasibility, acceptability, and initial outcomes of the adapted intervention in a sample of 10 low-income caregivers of children with externalizing behavior problems who were attending a community-based therapeutic summer program. Caregivers attended a once weekly (1.5-hour) intervention group, which was embedded in an 8-week community-based therapeutic program for children with externalizing behavior, and completed questionnaires at pretest, posttest, and 1 month following the intervention, and completed interviews about their experiences. Caregiver satisfaction with the adapted intervention was high, and fidelity and attendance measures suggested the intervention was feasible. Preliminary results showed postintervention improvements in caregivers’ skills in managing screen media use, including increases in caregiver self-efficacy to manage and set limits around screen media use. Results suggest that leveraging existing parenting interventions to promote healthy media use habits may be a promising avenue to maximize reach to families with children with externalizing behavior.

Targeting belongingness among older people through engagement in senior centres: intervention development study in Denmark.

Adults often experience a loss of social relations and sense of belonging in later life, leading to the risk of social isolation. Municipal senior centres offer a potential site for intervention, as they provide social communities targeting older people. However, not all older people find it easy to access these social communities due to experiencing physical and/or psychosocial frailties and could therefore continue to experience a decline in social relations and sense of belonging, which potentiates poor physical and psychosocial health and well-being. To date, there are limited evidence-based interventions in Denmark. The present article describes the development of an intervention to increase belongingness and decrease social isolation among older people with frailties who attend Danish municipal senior centres. The development process was conducted with reference to the INDEX (IdentifyiNg and assessing different approaches to DEveloping compleX intervention) guidance. The development process resulted in a 6-month supportive intervention, consisting of four elements: skills development workshops for all staff members; a start conversation including frailty screening; allocation of a 'buddy' among existing service users; and monthly follow-up conversations with staff members. This theory-informed approach can progress to feasibility testing and outcome evaluation in order to generate an evidence base. Concurrently, the article reflects on current guidance for intervention development and how it may be used and optimized to strengthen developmental processes in the future.

Robotic gastrectomy is safe in geriatric patients with gastric cancer: a retrospective cohort study.

The efficacy of robotic surgery in oncological operations has been demonstrated, but its applicability in the elderly population (≥70 years) is limited in studies. This study aims to investigate the feasibility, safety, and short-term outcomes of robotic surgery in gastric cancer surgery in geriatric patients. Patients who underwent robotic surgery for gastric cancer between July 2021 and September 2023 were included in the study. Patients were divided into two groups: the elderly group (≥70 years) and the younger group (<70 years). Demographic data, clinical findings, perioperative outcomes, and pathology results were analyzed and compared between the two groups. 63 patients were included in our study. Group 1, the younger patients (<70 years), consisted of 44 patients, while Group 2, the older patients (>70 years), consisted of 19 patients. The male gender was dominant in both groups (70.5% vs. 78.9%, p=0.486). ASA 2 was the most common score in both groups (70.5% vs. 52.6%, p=0.261). Group 2 had lower hemoglobin (11.3 vs. 10.1, p=0.017) and albumin levels (39.9 vs. 37.6, p=0.049). The average operation times were similar in both groups (255 min vs. 242 min, p=0.457). The median postoperative hospital stay was 5 days in both groups. The distributions of postoperative complications according to the Clavien-Dindo classification were similar. Postoperative 30-day mortality was observed in one patient in Group 2. The 90-day hospital readmission rates were similar (11.3% vs. 10.6%, p=0.459). The average tumor diameters were similar (38 mm vs. 48 mm, p=0.165), as were the numbers of dissected lymph nodes (35 vs. 34, p=0.796). According to pathology results, T4a tumors were most common in Group 1 and T0 tumors in Group 2 (34.1% vs. 31.6%, p=0.149). The most common lymph node involvements were N0 in Group 1 and N1 in Group 2 (36.4% vs. 36.8%, p=0.515). Robotic surgery in gastric cancer is considered a safe and feasible method in the elderly population due to its successful early outcomes, suggesting its reliability and effectiveness.

An Uncoventional Technique: Outflow Vein Tributary access for Central Vein and Cephalic Arch Angioplasty in Dysfunctional AVF

Abstract Introduction: Central venous stenosis (CVS) is a significant and frequently encountered problem in managing hemodialysis (HD) patients. Venous hypertension, often accompanied by severe symptoms, undermines the integrity of the HD access circuit. In CVS, dialysis through an arteriovenous (AV) fistula is usually inefficient, with high recirculation rates and prolonged bleeding after dialysis. Interventions for central vein stenosis in patients with AV access are typically performed with a direct puncture of the fistula outflow vein or taking access from the femoral vein, jugular vein, axillary vein, and basilic vein. Commonly encountered complications with taking access from the fistula vein-puncture site bleeding, hematoma, pseudoaneurysm, thrombosis of arteriovenous fistula; complications noted with femoral vein access are groin hematoma, lower limb deep-vein thrombosis, need for patient immobilization, and groin compression. An alternative approach is to use the outflow vein tributary, such as the cephalic vein tributary, as an access to avoid these potential complications. Aim and Objective: The objective of this study was to evaluate the feasibility and clinical outcomes of central vein and cephalic vein arch angioplasty, utilizing an outflow vein tributary as access, for managing symptomatic CVS in dialysis patients with upper limb vascular access and significant ipsilateral limb edema. Methodology: In a Prospective interventional study conducted at 2 Tertiary care Institutes between 2022 and 2023, a total of 34 patients underwent central vein and cephalic arch angioplasty utilizing an outflow vein tributary as access. Follow-up duration varied among patients. Results: During a 1-year period, a total of 34 patients (20 male and 14 female) underwent interventions for central vein stenosis using a tributary of the outflow vein as an access. These interventions encompassed lesions in the SVC, innominate vein, subclavian vein, cephalic arch, and multisegmental disease. The technical success rate for endovascular treatment stood at 88%. However, in four patients, we encountered difficulties in crossing the lesion despite employing additional access from the great saphenous vein (GSV). Notably, in 23 cases, the entire procedure was successfully completed using access from the tributary vein, whereas in seven patients, supplementary access was obtained from the right GSV. Importantly, none of the patients experienced access site complications. Conclusion: The use of tributary veins as access allows for the use of wide bore sheaths without encountering complications when addressing central vein pathology. Our findings indicate that employing outflow vein tributaries as access for endovascular treatment is both safe and effective in managing central venous disease.

Instrumentation of hypoplastic pedicles with patient-specific guides

PurposeHypoplastic pedicles of the thoracolumbar spine (<5 mm diameter) are often found in syndromic deformities of the spine and pose a challenge in pedicle screw instrumentation. 3D-printed patient-specific guides might help overcome anatomical difficulties when instrumenting pedicles with screws, thereby reducing the necessity for less effective fixation methods such as hooks or sublaminar wires. In this study, the surgical feasibility and clinical outcome of patients with hypoplastic pedicles following pedicle screw instrumentation with 3D-printed patient-specific guides were assessed.MethodsHypoplastic pedicles were identified on preoperative computed tomography (CT) scans in six patients undergoing posterior spinal fusion surgery between 2017 and 2020. Based on these preoperative CT scans, patient-specific guides were produced to help with screw instrumentation of these thin pedicles. Postoperatively, pedicle-screw-related complications or revisions were analyzed.Results93/105 (88.6%) pedicle screws placed with patient-specific guides were instrumented. 62/93 (66.7%) of these instrumented pedicles were defined as hypoplastic with a mean width of 3.07 mm (SD ±0.98 mm, 95% CI [2.82–3.32]). Overall, 6 complications in the 62 hypoplastic pedicles (9.7%) were observed and included intraoperatively managed 4 cerebrospinal fluid leaks, 1 pneumothorax and 1 delayed revision due to 2 lumbar screws (2/62, 3.3%) impinging the L3 nerve root causing a painful radiculopathy. The mean follow-up time was 26.7 (SD ±11.7) months. Complications were only noted when the pedicle-width-to-screw-diameter ratio measured less than 0.62.ConclusionPatient-specific 3D-printed guides can aid in challenging instrumentation of hypoplastic pedicles in the thoracolumbar spine, especially if the pedicle-width-to-screw-diameter ratio is greater than 0.62.

Comparison of time-matched aerobic, resistance or combined exercise training in women living with obesity: The EXOFFIT study.

Improvements in cardiorespiratory fitness (CRF) have been shown to largely attenuate the negative health risks associated with obesity. To date, literature on women with obesity has focused upon the evaluation of aerobic-based exercise interventions. Hence, there is a need to evaluate resistance and combined interventions with this cohort. This study aimed to evaluate the feasibility and efficacy of three exercise modalities in women with obesity for improving CRF, strength, body composition and other health outcomes. Sixty-seven women with obesity were randomly assigned to the control (CON) or one of three exercise groups (aerobic [AE], resistance [RE], COM). Exercise groups were trained x3 times/week for 12weeks (up to 150-min/week). Feasibility outcomes included adherence, attendance, recruitment and retention rates and adverse events. Secondary outcomes were CRF (predicted VO2 max), body composition (body weight [BW], waist circumference [WC], body fat percentage [%BF], fat mass [FM] and lean mass) and strength (5RM bench press, leg dynamometry, grip strength) and self-reported measures of physical activity, mood, sleep, pain and quality of life. Findings support the feasibility of all three exercise modalities in terms of adherence, attendance, and retention. Interventions with a resistance component (COM and RE) were associated with the greatest improvements across the broad range of health outcomes measured. Combined was the most promising for body composition outcomes including body mass index (Effect size [ES]=0.79, p=0.04), BW (ES=0.75, p=0.05), %BF (ES=0.77, p=0.04), FM (ES=0.83, p=0.03) and WC (ES=0.90, p=0.02), physical activity (i.e., moderate physical activity [ES=0.69, p=0.07), mood (ES=0.83, p=0.03) and sleep (ES=0.78, p=0.04). Resistance was most promising for CRF (ES=1.47, p=0.002), strength (i.e., bench press [ES=2.88, p=<0.001]) and pain (i.e., pain severity [ES=0.40, p=0.31]). For health outcomes, these results indicate the importance of including a resistance component when prescribing exercise for women with obesity to achieve meaningful improvements. ISRCTN13517067.

Objective assessment of postural ergonomics in neurosurgery: integrating wearable technology in the operating room.

Physical stress associated with the static posture of neurosurgeons over prolonged periods can result in fatigue and musculoskeletal disorders. Objective assessment of surgical ergonomics may contribute to postural awareness and prevent further complications. This pilot study examined the feasibility of using wearable technology as a biofeedback tool to address this gap. Ten neurosurgeons, including 5 attendings (all faculty) and 5 trainees (1 fellow, 4 residents), were recruited and equipped with two wearable sensors attached to the back of their head and their upper back. The sensors collected the average time spent in extended (≤ -10°), neutral (> -10° and < 10°), and flexed (≥ 10°) static postures (undetected activity for more than 10 seconds) during spine and cranial procedures. Feasibility outcomes aimed for more than 70% of accurate data collection. Exploratory outcomes included the comparison of postural variability within and between participants adjusted to their demographics excluding nonrelated surgical activities, and postoperative self-assessment surveys. Sixteen (80%) of 20 possible recordings were successfully collected and analyzed from 11 procedures (8 spine, 3 cranial). Surgeons maintained a static posture during 52.7% of the active surgical time (mean 1.58 hrs). During spine procedures, all surgeons used an exoscope while standing, leading to a significantly longer time spent in a neutral static posture (p < 0.001, partial η2 = 0.14): attendings remained longer in a neutral static posture (36.4% ± 15.3%) than in the extended (9% ± 6.3%) and flexed (5.7% ± 3.4%) static postures; trainees also remained longer in a neutral static posture (30.2% ± 13.8%) than in the extended (11.1% ± 6.3%) and flexed (11.9% ± 6.6%) static postures. During cranial procedures, surgeons intermittently transitioned between standing/exoscope use and sitting/microscope use, with trainees spending a shorter time in a neutral static posture (16.3% vs 48.5%, p < 0.001) and a longer time in a flexed static posture (18.5% vs 2.7%, p < 0.001) compared with attendings. Additionally, longer cranial procedures correlated with surgeons spending a longer time (r = 0.94) in any static posture (extended, flexed, and neutral), with taller surgeons exhibiting longer periods in flexed and extended static postures (r = 0.86). Postoperative self-assessment revealed that attendings perceived spine procedures as more difficult than trainees (p = 0.029), while trainees found cranial procedures to be of greater difficulty than spine procedures (p = 0.012). Attendings felt more stressed (p = 0.048), less calmed (p = 0.024), less relaxed (p = 0.048), and experienced greater stiffness in their upper body (p = 0.048) and more shoulder pain (p = 0.024) during cranial versus spine procedures. Wearable technology is feasible to assess postural ergonomics and provide objective biofeedback to neurosurgeons during spine and cranial procedures. This study showed reproducibility for future comparative protocols focused on correcting posture and surgical ergonomic education.

Enhancing body image satisfaction and well-being among early adolescents: Feasibility and preliminary outcomes of the mind. body. voice. program

Although most research has emphasized high-school and college-aged women, body dissatisfaction and eating disorder behavior are also a concern for middle-school girls. We partnered with Girls Inc., a community-based organization to explore feasibility and preliminary outcomes of the mind. body. voice. (m.b.v.) program with a middle-school-aged cohort. The program was collaboratively designed with youth, focusing on body image satisfaction, disordered eating risk factors, and mental health and well-being. The work occurred during the COVID-19 pandemic, offering a unique opportunity to assess the promise of the program under difficult extenuating circumstances. In an open-trial design, we assessed change from pre- to post-program administered with two cohorts, one delivered remotely in 2020 (n = 17) and one in-person in 2021 (n = 13). Findings indicated that participation in the m.b.v. program was associated among both cohorts with significant decreases in negative body judgment and adherence to cultural appearance biases, and significant increases in body awareness, agency, and positive self-regard, as well as significant reductions in negative affect. Results support the feasibility and promise of both remote and in-person administration of the program targeting young adolescents, and in partnership with a well-established community-based organization.

A whole food, plant-based randomized controlled trial in metastatic breast cancer: feasibility, nutrient, and patient-reported outcomes

PurposeQuality of life (QOL) is among the most important outcomes for women with metastatic breast cancer (MBC), and it predicts survival. QOL is negatively impacted by cognitive impairment, fatigue, and weight gain. We assessed whether a whole food, plant-based (WFPB) diet-promoting weight loss is feasible and might improve QOL.MethodsWomen with MBC on stable systemic treatments were randomized 2:1 to 1) WFPB dietary intervention (n = 21) or 2) usual care (n = 11) for 8 weeks. Participants attended weekly education visits and consumed an ad libitum WFPB diet (3 prepared meals/day provided). Patient-reported outcomes and 3-day food records were assessed at baseline and 8 weeks. The effects of WFPB diet on changes in outcomes were assessed by analysis of covariance model controlling for baseline.Results20 intervention and 10 control participants completed the trial. Intervention participants were highly adherent to the WFPB diet (94.3 % total calories on-plan). Intervention group nutrient intakes changed significantly including dietary fat (35.8 % to 20.4 % percent calories from fat, p < 0.001) and fiber content (12.7 to 30.8 g fiber/1000 kcal, p < 0.001). Perceived cognitive function (FACT-Cog total + 16.1; 95 % confidence interval [CI] = 0.8–31.7; p = 0.040) and emotional well-being (FACT-B emotional well-being subscale + 2.3; CI = 0.5–4.1; p = 0.016) improved in the WFPB versus the control group. Fatigue, measured by the BFI, improved within the WFPB group for fatigue severity (M = 4.7 ± 2.5[SD] to 3.7 ± 2.3, p = 0.047) and fatigue at its worst (5.8 ± 2.8 to 4.4 ± 2.4, p = 0.011).ConclusionsSignificant dietary changes in this population are feasible and may improve QOL by improving treatment-related symptoms. Additional study is warranted.Trial Registration: ClinicalTrials.gov identifier: NCT03045289. Registered 7 February 2017.

SMART Family and Friends: Feasibility and outcomes of a video-conference delivered intervention for families impacted by another's methamphetamine use

IntroductionFamilies affected by another's substance use, including methamphetamine, experience harms to their mental and physical health. Yet, research has paid little attention to support and service needs of this population. This pilot study examines the feasibility and outcomes of SMART Family and Friends, a video-conference-delivered mutual-support group targeting families affected by another's methamphetamine use. MethodsRecruitment for this study occurred between March–October 2021 via the SMART Recovery Australia website. Participants were English-speaking Australian residents, ≥18 years, affected by another's methamphetamine use, interested in participating in a manualised eight-module group delivered via video-conferencing. Feasibility was evaluated by attendance rates, participant satisfaction, fidelity ratings, and semi-structured interviews. Measures of distress, quality of life, and family functioning assessed outcomes at baseline and one-month post-treatment conclusion. ResultsForty-three participants commenced SMART Family and Friends groups. 84 % (n = 36) completed ≥4 modules, 67 % (n = 29) completed ≥6, and 42 % (n = 18) completed all 8 modules. Participant satisfaction (M = 4.32, SD = 0.66, out of 5) and facilitator fidelity (>94 % for all modules) were high. A within-group analysis, without comparison condition demonstrated significant improvements in psychological distress (d = 0.38), family impact (d = 0.64), family strain symptoms (d = 0.48), and total family burden (d = 0.69) post-treatment. Qualitative findings illustrated the benefits and challenges of the video-conference-delivered group, as well as recommendations for improvement. ConclusionsResults provide initial support for the feasibility and positive outcomes of the SMART Family and Friends program. These findings demonstrate the successful provision of a mutual-support group for affected families delivered via video-conferencing, and merit further sufficiently powered randomised-control-trials to evaluate efficacy.