Feasibility Outcomes Research Articles

Positive family connections for families of children with a developmental disability: Cluster randomized controlled trial.

Positive Family Connections is a coproduced, positively oriented, family-systems program for families of children with a developmental disability aged 8-13 years. The study was a feasibility cluster randomized-controlled trial which was registered prospectively (International Standard Randomised Controlled Trial Number 14809884). Families (clusters) were randomized 1:1 to take part in Positive Family Connections immediately or to a waitlist condition and were followed up 4 months and 9 months after randomization. Feasibility outcomes included participant and facilitator recruitment rates, retention, intervention adherence, and fidelity. The proposed primary outcome measure was the family APGAR, a measure of family functioning. Quantitative data were analyzed using multilevel modeling. Sixty families (60 primary parental carers and 13 second carers) were randomized. 73.33% of primary parental carers and 71.43% of second carers in the intervention group attended ≥ 4 intervention sessions, and fidelity of delivery was high (M = 94.02% intervention components delivered). Retention for the proposed primary outcome was 97.26% at 4-month follow-up and 98.63% at 9-month follow-up. Intervention condition was not associated with family APGAR scores at 9-month follow-up (estimate = 0.06, 95% CI [-0.49, 0.61], p = .86, Hedges' g = 0.03, 95% CI [-0.43, 0.49]). However, meaningful improvements were observed for other secondary outcomes related to parental well-being and family relationships. A definitive randomized-controlled trial of Positive Family Connections is feasible. Preliminary evaluation of outcomes shows that Positive Family Connections may be beneficial for parental psychological well-being and family relationships. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Head Injury Evaluation and Ambulance Diagnosis (HOME) Study protocol: a feasibility study assessing the implementation of the Canadian CT Head Rule in the prehospital setting

IntroductionTraumatic brain injury (TBI) is a common presentation in the prehospital environment. At present, paramedics do not routinely use tools to identify low-risk patients who could be left at scene...

Phase 1b trial of IFx-Hu2.0, a novel in situ cancer vaccine, in checkpoint inhibitor-resistant Merkel cell carcinoma (MCC) and cutaneous squamous cell carcinoma (cSCC).

9592 Background: MCC and cSCC have limited treatment options when refractory to immune checkpoint inhibitor (ICI) therapy. IFx-Hu2.0 (IFx) is a plasmid DNA encoding for an immunogenic bacterial protein, Emm55, formulated with a transfection agent for direct intra-tumoral (IT) injection. In this Phase 1b study, we evaluated the safety and efficacy of different schedules of IT IFx in patients (pts) with advanced MCC or cSCC. Methods: In the first trial stage (n=9), IT IFx was administered in up to 3 lesions on 3 schedules following a 3+3 exposure escalation schema; weekly x 1, 2, or 3. In the second trial expansion stage (n=11), IT IFx was administered weekly x 3. The primary objective of the study was to establish safety and feasibility of repeated IT administrations of the investigational agent. ≥80% completion of planned study therapy was predefined as a successful feasibility outcome. Given the proposed potential for immune priming effects of IFx, we performed an unplanned exploratory analysis of post-protocol treatment efficacy to evaluate response to ICI rechallenge. Results: We treated 22 pts (MCC, 13; cSCC, 9). All pts had received prior anti-PD(L)1 based treatment with disease progression being the reason for ICI discontinuation in all patients but one. Two pts did not complete planned study therapy due to rapid clinical progression and were replaced but included in the safety analysis. IT IFx was well tolerated at all dose schedules evaluated with 1 high-grade toxicity deemed possibly treatment related (G3 hepatitis in a patient recently treated with ICI). The study therefore met predefined study endpoints for safety and efficacy. After protocol specified IT therapy, 11 MCC pts and 6 cSCC pts were treated with anti-PD(L)1 based therapy as the immediate post-protocol treatment. Five of 9 (56%) evaluable MCC patients and 1 of 7 (14%) cSCC patients experienced an objective response to this ICI rechallenge, with duration of response ongoing in 4 patients (6+, 19+, 21+, 23+ months) and the two other responses lasting 23 and 33 months. The two remaining MCC patients were not evaluable for response from IO rechallenge due to radiation administered to the only measurable disease site(s), but both remain progression free at 11+ and 13+ months with previously progressive disease. Conclusions: IT IFx-Hu2.0 is safe and feasible to administer at weekly dosing repeated up to 3 weeks. An unplanned exploratory analysis revealed frequent (56%) and durable responses in advanced MCC to ICI re-challenge despite prior resistance to this class of drug, suggesting that IFx induced an immune priming effect. Preliminary biomarker analyses to investigate this phenomenon are ongoing and will be presented. Clinical trial information: NCT04160065 .

Evaluation of a complex survivorship intervention incorporating electronic patient-reported outcomes in early stage breast and gynecologic cancer: Results from the Linking You to Support and Advice (LYSA) randomized controlled trial.

1505 Background: Expert consensus supports a multidisciplinary strategy in cancer survivorship care to enhance patient outcomes and quality of life. We hypothesized that introducing a women’s survivorship clinic into routine follow up care would be feasible, and associated with improved symptom management and quality of life (QOL). Methods: LYSA was a multisite randomized controlled trial with parallel arms (experimental and active comparator), co-designed with public and patient involvement. Eligibility: early-stage hormone receptor-positive breast or gynaecologic cancer (GYN) within 12 months of completing primary therapy, and internet access (NCT05035173). Experimental arm attended a nurse-led clinic targeting symptom management, and dietetic consultation. Electronic patient-reported outcome (ePRO) assessments were undertaken at baseline, and bimonthly to 12 months. An online trigger alert system facilitated symptom management. Active comparator arm attended the nurse-led clinic at baseline and end of study. Primary endpoint (feasibility): Proportions of participants completing baseline and follow up ePRO surveys, and engaging in healthcare consultations after ePRO triggers. Pilot efficacy endpoints: changes in cancer-related symptom (PROMIS, PRO-CTCAE, Fear of Cancer Recurrence), health-related QOL Questionnaires (EORTC-QLQ, EQ5D5L) . Sample size target (n=200) facilitated feasibility outcomes. Between arm differences were estimated using generalized linear model, adjusted for baseline outcome. Results: 200 women were randomized, March 2021-August 2022 across two sites; 84% breast and 16% GYN. Consent was obtained in clinic (51%), video call (33%) or phone (16%). Median age was 54 (range 23-78). Of the 173 participants completing the study (n = 90 experimental, 83 comparator), all completed both baseline and end of study surveys. Following symptom triggers (experimental arm), there were 322 study nurse visits across 86 participants, and 243 dietician visits across 73 participants. Engagement with healthcare and other supportive resources was approximately twice more than comparator arm, due to referral. There were no notable between-arm differences with respect to EQ5D5L items at study end. However, experimental arm participants had better EORTC Total scores at study end relative to comparator (difference in means -3.87 95%CI -6.58 to -1.16, p=0.005). There were also significant (p < 0.05) differences observed between the arms for 8/12 symptom items reflecting less fatigue, anxiety and depression in experimental arm at study end. Conclusions: The LYSA trial met its primary feasibility endpoint, with high rates of ePRO completion. Secondary endpoint analysis is ongoing including an economic analysis and future studies. Clinical trial information: NCT05035173 .

Cognitive therapy for depression in tuberculosis treatment: protocol for multicentre pragmatic parallel arm randomised control trial with an internal pilot

Introduction and objectivesThere is an unmet need to develop high-quality evidence addressing tuberculosis (TB)-related mental health comorbidity, particularly in the context of lower-middle-income countries. This study aims to examine the...

Multicentric Use of Commercially Available Infrarenal Endografts During Fenestrated Endovascular Aortic Repair: A Feasibility Study.

This study aimed to assess the feasibility and short-term outcomes of different manufactured proximal and distal stent graft components during fenestrated endovascular aortic repair (FEVAR). A multicenter retrospective review was conducted at 3 aortic centers, involving all consecutive patients who underwent FEVAR utilizing a customized Dacron-based tubular proximal and a distal bifurcated polytetrafluoreten (PTFE)-based commercially available stent grafts. Primary outcomes were 30 day mortality, major adverse events, and technical and clinical success. Secondary outcomes assessed stent graft migration, occurrence of types I/III endoleak, and reintervention. A total of 23 FEVAR cases across all centers were included in this study. Technical success was achieved in all cases, with a median procedure time of 183 (153-244) minutes. There were no major adverse events, except for 1 transient acute renal failure. The median follow-up period was 23 (17-28) months. All target vessels retained patent with the exception of 1 right renal fenestration that showed signs of kinking at the first follow-up, and despite secondary intervention with relining and distal extension, there was an occlusion afterward and 1 hepatic artery with a separate fenestration. This and 1 successful relining of a superior mesenteric artery kink were the only reinterventions in this cohort. One case of persistent type 1b endoleak was reported in a patient with chronic type B aortic dissection, which resolved with distal extension on the external iliac artery 5 months after the index procedure. No deaths occurred throughout the follow-up with, and there were no signs of stent graft migration or type 3 endoleak. The use of commercially available PTFE-based bifurcated stent grafts to extend distally the tubular graft appears to be a feasible approach during FEVAR, with promising short-term outcomes. Further studies are necessary to define the applicability of this solution and evaluate long-term outcomes. This multicentric study on fenestrated endovascular aortic repair (FEVAR) demonstrates the feasibility and good short-term outcomes of utilizing a PTFE-based commercially available stent graft to extend the proximal tubular custom-made fenestrated stent graft. The high technical success rate, absence of major adverse events, and low occurrence of complications such as stent graft migration and endoleaks highlight the potential clinical benefits of this approach with an off-the-shelf distal extension whose delivery system does not cross the fenestrations intraoperatively.

Robotic distal gastrectomy using a novel pre-emptive supra-pancreatic approach without duodenal transection in the dissection of D2 lymph nodes for gastric cancer.

Robot-assisted surgery has shown remarkable progress as a minimally invasive procedure for gastric cancer. This study aimed to compare the pre-emptive suprapancreatic approach without duodenal transection and the conventional approach in terms of perioperative feasibility and short-term surgical outcomes. We retrospectively analyzed all patients who underwent robotic distal gastrectomy with D2 lymph node dissection using the da Vinci Xi robotic system between December 2021 and April 2023 and categorized them into two groups for comparison. Patients treated using the pre-emptive suprapancreatic approach (observation group) were compared with those who received the conventional approach (control group). Employing one-to-one propensity score matching, we evaluated the postoperative morbidity and short-term outcomes in these two distinct groups to assess the efficacy and safety of the novel surgical technique. This study enrolled 131 patients: 70 in the observation group and 61 in the control group. After propensity score matching, the operative times were significantly longer in the control group than in the observation group (229.10 ± 33.96 vs. 174.84 ± 18.37, p <0.001). The mean blood loss was lower in the observation group than in the control group (25.20 ± 11.18 vs. 85.00 ± 38.78, p<0.001). Additionally, the observation group exhibited a higher number of retrieved lymph nodes, including suprapyloric, perigastric, and superior pancreatic lymph nodes (28.69 ± 5.48 vs. 19.21 ± 2.89, p <0.001; 4.98 ± 1.27 vs. 4.29 ± 1.21, p = 0.012; 10.52 ± 2.39 vs. 5.50 ± 1.62, p <0.001; 6.26 ± 2.64 vs. 5.00 ± 1.72, p = 0.029). Drain amylase levels in the observation group were significantly lower than those in the control group (30.08 ± 33.74 vs. 69.14 ± 66.81, p <0.001). This study revealed that using the pre-emptive suprapancreatic approach without duodenal transection in the dissection of D2 lymph nodes for gastric cancer is a safe and feasible procedure in terms of surgical outcomes.

The Feasibility and Efficacy of Remote App-Guided Home Exercises for Frozen Shoulder: A Pilot Study.

Home exercise programs are beneficial in managing frozen shoulder (FS), yet adherence remains challenging. This pilot study introduces the remote app, Defrozen, designed for home exercises and assesses its feasibility and clinical outcomes in FS patients undergoing intra-articular and sub-acromial corticosteroid treatment. Over a four-week period, patients used the Defrozen-app, engaging in guided exercises. The feasibility of the intervention was assessed through several measurement scales, including adherence, the Technology Acceptance Model 2 (TAM2), the System Usability Scale (SUS), and User Satisfaction and Engagement (USE). Clinical outcomes included pain scale, Oxford Shoulder Score (OSS), Quick Disability of the Arm, Shoulder, and Hand (QuickDASH) Score, and passive range of motion. The TAM2 results indicated high perceived usefulness (4.5/5), ease of use (4.8/5), and intention to use (4.4/5); the SUS score was high at 81.7/100, complemented by USE scores reflecting ease of learning (4.9/5) and satisfaction (4.3/5). Clinical outcomes showed significant pain reduction, improved shoulder function, reduced shoulder-related disability, and increased shoulder range of motion. These findings suggest the Defrozen-app as a promising solution for FS, significantly improving adherence and showing potential to enhance clinical outcomes. However, these clinical outcome results are preliminary and necessitate further validation through a large-scale randomized controlled trial to definitively confirm efficacy and assess long-term benefits.

Single Center Experience of Eus-Guided Cystogastrostomy and Lumen-Apposing Metal Stent (LAMS) Positioning in Children with Pancreatic Fluid Collections: A Case Series.

Pancreatic fluid collections (PFCs) are a well-known complication of pancreatitis. PFCs operative management includes percutaneous, endoscopic or surgical drainage. Even if in adult patients, endoscopic drainage is a well-established treatment, few data are available in pediatric setting. We report our single-center experience of EUS-guided cystogastrostomy and lumen-apposing metal stent (LAMS) positioning in children with PFCs; this, at the best of our knowledge, has never been reported before. All consecutive children with PFCs between April 2020 and November 2022 were enrolled in this retrospective study. PFCs were preoperatively evaluated with MRI or CT scan. All the procedures were performed under general anesthesia. A LAMS Hot-AxiosTM 10 × 15 mm was placed in all patients. We evaluated technical feasibility and clinical outcomes, including complications and recurrence rates. Follow-up included clinical observation, blood tests and US. EUS-guided cystogastrostomy was performed in 3 children (2 males; median age 13.2 years). Median maximum cyst diameter was 14.7 cm (range 10-22 cm). Technical and clinical success rates were 100%. No intra or post-operative complications occurred. Our experience suggests that this can be considered a safe and feasible treatment of PCFs even in the pediatric population, as long as the procedure is performed by an expert Endoscopist in a pediatric tertiary-level Center.

A randomized feasibility study of a positive psychology journaling intervention to support recovery from substance-use disorders

BackgroundIndividuals in early recovery face significant biopsychosocial stressors causing a preponderance of negative affect. Novel interventions are needed to improve mood and well-being to support recovery. Positive Recovery Journaling (PRJ) combines elements of positive psychology, behavioral activation, and journaling to emphasize what is going right and to encourage small, positive steps that align with an individual's values to make life in recovery more rewarding and therefore more reinforcing. Our objective was to determine PRJ's feasibility, acceptability, and impact on a set of strengths-based, multidimensional aspects of recovery, including satisfaction with life, happiness with recovery, and commitment to sobriety. MethodsThe study randomized adults in substance-use disorder treatment (N = 81) to PRJ or control. Those in PRJ were asked to practice PRJ daily and complete online surveys for four weeks; those in the control group completed online surveys for four weeks. We used multi-level modelling to determine intercept and slope for feasibility and acceptability outcomes as well as to compare differences in recovery indicators between treatment and control at baseline and Weeks 2, 4, and 8. We conducted intention-to-treat and per-protocol analyses for each recovery indicator. ResultsParticipants were 53 % female, and 26 % Black, Indigenous, People of Color (BIPOC) and mean age of 39 years. PRJ participants attended 71 % of groups and completed 56 % of the daily PRJ entries. Treatment and control groups rated their study tasks (PRJ for the treatment group, surveys for the control group) as equally easy; however, the PRJ group rated PRJ as significantly more satisfying, helpful, and pleasant. Treatment and control were not significantly different on any recovery indicator. In post hoc analyses, we found that for those with <90 days sobriety at baseline (51 %), PRJ had a statistically significant beneficial effect for satisfaction with life, happiness with recovery, and numerous secondary recovery indicators. DiscussionResults suggest a positive impact of PRJ on numerous recovery indices for those in earliest recovery. Integrating PRJ into support services among those with <90 days sobriety could reinforce what is going well in recovery to encourage its continued maintenance and thereby improve treatment outcomes.

Pre-operative mechanical bowel preparation and prophylactic oral antibiotics for pediatric patients undergoing elective colorectal surgery: a protocol for a randomized controlled feasibility trial

BackgroundInfections after elective colorectal surgery remain a significant burden for patients and the healthcare system. Adult studies suggest that the combination of oral antibiotics and mechanical bowel preparation is effective at reducing infections after colorectal surgery. In children, there is limited evidence for either of these practices and the utility of combining oral antibiotics with mechanical bowel preparation remains uncertain.MethodsThis study aims to determine the feasibility of conducting a randomized controlled trial assessing the efficacy of oral antibiotics, with or without mechanical bowel preparation, in reducing the rates of post-operative infection in pediatric colorectal surgery. Participants aged 3 months to 18 years undergoing elective colorectal surgery will be randomized pre-operatively to one of three trial arms: (1) oral antibiotics; (2) oral antibiotics and mechanical bowel preparation; or (3) standard care. Twelve patients will be included in each trial arm. Feasibility outcomes of interest include the rate of participant recruitment, post-randomization exclusions, protocol deviations, adverse events, and missed follow-up appointments. Secondary outcomes include the rate of post-operative surgical site infections, length of hospital stay, time to full enteral feeds, reoperation, readmission, and complications.DiscussionIf the results of this trial prove feasible, a multi-center trial will be completed with sufficient power to evaluate the optimal pre-operative bowel preperation for pediatric patients undergoing elective colorectal surgery.Trial registrationClinicalTrials.gov: NCT03593252.

Focal pulsed field ablation for organised atrial tachyarrhythmias: one to rule them all

Abstract Background Focal pulsed field ablation (fPFA) has emerged as a versatile and innovative strategy for ablating atrial tachyarrhythmias (1). The primary objective of this study is to present the short-term safety characteristics, feasibility and procedural outcomes of fPFA in the management of organised atrial tachyarrhythmias. This report focuses on the commercial use of an innovative pulsed field ablation (PFA) generator, utilized in conjunction with commercially available focal, solid-tip ablation catheters, and complemented by 3D electro-anatomical mapping (3D-EAM). Methods Patients with organised atrial tachycardia treated using fPFA between August 2022 and September 2023 at our center were included in this retrospective analysis. Tachycardia mechanisms were identified with high-definition, multi-electrode mapping catheter paired with 3D-EAM system. Ablation lines, when targeting macro-reentrant arrhythmias were strategicaly positioned to adress critical isthmi when recognised or they were empirically placed between the anatomical obstacles ( including LA roof, anterior, mitral isthmus, upper septal and cavotricuspid line as deemed appropriate). Positioning of the fPFA catheter was guided by 3D-EAM, intracardiac ultrasound, and fluoroscopy (Figure 1). Bidirectional block verification was performed using standard criteria to assess acute procedural success. Glyceryl trinitrate boluses were administered prior to ablation in proximity to coronary arteries. Results In a cohort of 36 patients (median age 62 years; 12 females), we effectively mapped and treated a total of 51 distinct organised atrial tachyarrhythmias. These included 18 typical flutters, 3 roof-dependent macro-reentries, 4 posterior-wall micro-reentries, 15 peri-mitral macro-reentries, 8 anterior-wall micro-reentries and 3 biatrial macro-reentries via Bachman bundle. Our ablation strategy involved creating 21 cavotricuspid isthmus lines, 3 roof lines, 18 posterior wall lines, 11 anterior lines, 8 septal lines, and 15 mitral isthmus lines (Figure 2). Impressively, first-pass acute isolation with bidirectional block was achieved in 93% (54 of 58) of isthmus ablations and 94% (17 of 18) of left posterior wall lines. No ST segment alterations or other complications were observed during the periprocedural period. Conclusion In our cohort fPFA proved as a feasible, effective, and safe approach for treating organised atrial tacharrhythmias. The primary reason for designating this setup as our preferred choice for redo procedures lies in its versatility in addressing a wide range of arrhythmias. As ultra-fast pulmonary vein isolation (PVI) procedures become more prevalent with the expansion of PFA, the demand for an ideal setup capable of effectively targeting various substrates will become even more pronounced (2). Notably, our findings suggest superior suitability and efficacy when compared to bulkier, single-shot design PFA devices (3).Figure 1Figure 2

Focal pulsed field ablation in complex cases of atrial tachycardia - feasibility, outcome and safety of a novel technology

Abstract Introduction The importance of pulsed-field ablation (PFA) is rising in the field of catheter ablation. Nevertheless, the use of a single-shot devices is limited to pulmonary vein isolation (PVI). Thus, significance of technologies implementing point-by-point PFA is growing. A commercially available system uses radiofrequency (RF) catheters in combination with a PFA-generator. Data on the use is sparse, especially for treating atrial tachycardia (AT). The aim of this study was to evaluate feasibility, safety and mid-term outcomes of point-by-point PFA in complex cases of AT. Methods All consecutive patients treated with a focal PFA-catheter (N = 34) suffering from AT were included. A high density map was created in all patients. Established RF catheters were employed as PFA catheters with the PFA generator. Except for the ablation generator, the standard setting at our clinic for ablation of AT was not changed. In case of sinus rhythm at the beginning, burst stimulation was performed in order to induce the clinical AT. Acute procedure success was defined as creation of ablation lesions preventing the mechanism of the clinical tachycardia and/or non-inducibility of the clinical AT. Outcome and safety was evaluated during the hospital stay and visits at our outpatient clinic, including 7d-Holter-ECG. Results In all 34 included patients, acute procedure success was achieved. Baseline characteristics are listed in table 1. In average, patients had 1,21 ± 0,88 ablations before, 67,6% of patients had linear lesions in the past. Mean procedure duration was 102,7 ± 30,3 min, the LA dwell time was 75,0 ± 24,7 min (table 2). Any desired lesion set was accomplished (pulmonary vein isolation, linear lesions or ablation of focal AT/localized reentry) with the focal PFA technology. Linear lesions were ablated in 32 (94,1%) patients, while a pulmonary vein isolation was performed in 12 patients (35,3%). Ablation of localized reentries was necessary in two patients (5,9%). In total, 51 linear lesions were created: 27 anterior lines, 18 roof lines, 5 CTI-lines and one posterior box; bidirectional block was proven in all cases. Furthermore, three patients suffered a macro-reentry due to reconnected pulmonary veins. The site of termination of the tachycardia is shown in Figure 1. No procedure-related minor or major complications occurred (no groin complications, no stroke, no pericardial tamponade). After a mean follow-up of 179,4 ± 107,8 days, 8 patients (23,5%) suffered a recurrence of any atrial arrhythmia. Conclusion Applying focal PFA with well-known radiofrequency ablation catheters is safe and efficient, also in cases of atrial tachycardia. The integration of the new system into clinical practice is feasible and did not prolong the procedures. Acute procedure success was achieved in all cases. For further evaluation of efficacy and safety, a control group of patients treated with radiofrequency or a randomized trial is needed.

#2121 The Kidney-specific Psychosocial ASSessment and support (Kidney PASSPORT) feasibility trial

Abstract Background and Aims Psychosocial interventions for depressive and anxiety symptoms are effective in CKD, but studies mainly focus on people on dialysis. Little is known about the role of screening and prevention of common mental health difficulties in early CKD. This trial assessed the research feasibility of an intervention to screen for psychological distress in CKD and deliver prevention approaches for sub-threshold symptoms. The intervention was facilitated by an Assistant Wellbeing Practitioner (AWP), a Band 3 healthcare assistant familiar with renal services and upskilled with specific competency-based training. Method We conducted a mixed-methods, one-year, single-centre, prospective, single-blind, wait-list, randomised controlled feasibility trial. We anticipated screening 250 individuals to identify 100 eligible, with a 40% screening positivity rate, a 45% participation rate and 20% attrition rate, to give 36 participants in the feasibility study. Primary outcomes are shown in Table 1. Potential participants were screened using an online self-completion questionnaire. Participants were randomised to 6 months of immediate or wait-list intervention. Data was collected using online self-report surveys, clinical research forms and semi-structured qualitative interviews. The trial was overseen by a steering committee and received the relevant ethics approvals. Funders included Kidney Care UK, the British Renal Society, the Royal Devon and Exeter Research Capacity Awards and the Exeter Kidney Unit development fund. Results We approached n = 233 people. Feasibility outcomes are shown in Table 2. Due to logistical issues an extension was obtained and in total n = 24 participants were recruited, agreed by the steering committee. All clinical research forms were completed. The most common intervention components were self-management and liaison with the clinical team. The median (interquartile range) difference in baseline and post intervention PHQ-9 score was −5 (−7, 0), n = 19, p = 0.003) and GAD-7 score was −7 (−8, −2), n = 19, p = 0.0002). Qualitative findings showed the AWP was seen as filling in the gaps left by other parts of the service. Key themes were accessibility, time availability, empathy, patient empowerment, and ability to empower the individual. Balance—especially family, work and health—was noted to be a challenge for participants. Importantly, the AWP was able to help participants overcome previous negative experiences. The trial provided valuable learning regarding role implementation, including recruitment, training, work patterns, everyday practicalities, and supervision arrangements. Conclusion We propose a novel intervention for screening and addressing early mental health problems in people with CKD. A single-centre feasibility design was appropriate. The screening positivity rate was lower than anticipated, informing samples for future trials. Outcome data collection via self-report surveys was not feasible. The intervention was well received, with the AWP being valued and self-help and clinical liaison being core elements. Significant reductions in depression and anxiety screening scores were observed. Despite the rigorous design, limitations included slow initial recruitment impacting the sample size and AWP role vulnerability. Future work includes adapting the AWP training and role based on trial learning and considering suitability for other long-term conditions. In conclusion, the AWP role shows promise in routine screening for and prevention of common mental health difficulties in CKD.

#1016 Kidney transplantation in highly sensitized patients with preformed donor-specific antibodies through personalized delisting strategies

Abstract Background and Aims This study explores a personalized delisting strategy enabling kidney transplantation in highly sensitized patients with preformed donor-specific anti-HLA antibodies (DSA) trying to minimize the risk of antibody-mediated rejection (ABMR). Method Retrospective single-centre analysis of 50 kidney transplant recipients with preformed DSA (preDSA) after employing a delisting strategy to enhance their access to transplantation, and without received a pre-transplant or immediate post-transplant desensitization protocol. The delisting approach focused on allowing less deleterious antibodies according to their mean fluorescence intensity (MFI), anti-HLA class and C1q study results. The strategy consisted on eliminating as prohibited HLA antigens those recognized by antibodies with the lowest MFI in the following order: 1st- MFI &amp;lt; 5000; 2nd- MFI &amp;lt; 10000; 3rd-Any MFI. Additionally, delisting prioritized a single locus in the following order: 1st- one of the HLA class I loci (A, B, or Cw); 2nd- the rest of the class I loci; 3rd- HLA-DP, followed by DR. C1q studies were performed before delisting and transplantation was contraindicated in the presence of DSA detected in the C1q assay. Two comparative cohorts included 50 sensitized recipients without pre-transplant DSA (SwoDSA) and 50 non-sensitized recipients (NS). Results The delisting strategy allowed transplantation with preformed DSA and demonstrated comparable rejection rates to SwoDSA and NS groups (16%, 14% and 8%, respectively; log-rank = 0.28). However, the occurrence of acute ABMR was 12% in the preDSA group, significantly higher than in SwoDSA (1%) and NS (0%) (log-rank = 0.0093). The immunological risk assumed in delisting correlated with ABMR incidence (patients with ABMR had significantly higher sum MFI [mean ± SD: 9301 ± 6340 vs 4492 ± 5641; p = 0.049]), emphasizing the importance of tailored strategies. DSA persistence after transplantation correlated with higher MFI and increased ABMR risk. Of note, 16% of preDSA patients developed de novo DSA versus only the 4% of SwoDSA and 0% of NS patients (p = 0.004). After a mean follow-up of 3.1 ± 2.1 years, the 1-, 3- and 5-year death-censored allograft survival rates were 100%, 90% and 78%, respectively, in the preDSA group; 98%, 84% and 84% in the SwoDSA group and 100% in NS group (log-rank = 0.02). Conclusion The present study demonstrates the feasibility and acceptable outcomes of kidney transplantation in highly sensitized patients with preformed DSA through a personalized delisting strategy without using desensitization protocols.

#1125 CAPD in ESRD and CLD patients with refractory ascites: a 12-month follow-up study

Abstract Background and Aims Refractory ascites secondary to chronic liver disease among ESRD patients are a major source of morbidity and mortality. Hemodialysis is frequently interrupted due to intradialytic hypotension and other complications which make ultrafiltration removal among CLD patients, a big challenge. This results in sub-optimal clearance which translates into poor quality of life along with recurrent admissions. CAPD in these patients is effective in providing a good clearance as well as removal of ascites with adequate ultrafiltration removal. There is a lack of data regarding the feasibility, safety, and clinical outcomes of CAPD among CLD patients with ascites. We conducted a study with objectives to evaluate serum albumin levels at baseline and 12 months, and to determine peritonitis rates and dialysis modality suitability in CLD patients. Method Study Design A retrospective cohort study. Study Population All hemodialysis patients with refractory ascites due to CLD. Refractory ascites was defined as the need for &amp;gt;5 therapeutic paracentesis in the last 3 months after optimal clinical, dietary and fluid management. All CLD patients were extensively counselled regarding high protein intake. Each patient visited either the Nephrologist or PD Nurse, renal dietician at least once in 4-6 weeks. Results Over a period of five years, 34 patients were included in the analysis to assess the efficacy of Continuous Ambulatory Peritoneal Dialysis (CAPD) for ascites management in chronic liver disease. Baseline characteristics are presented in Table 1. The frequency of ascites drainage prior to CAPD was every 3.4 weeks. Open catheter insertion was performed in 31 out of 34 patients. Serum albumin levels increased from 2.98 ± 0.4 g/dL at baseline to 3.1 ± 0.28 g/dL at 12 months (p = 0.21) (Fig. 1). Child-Pugh Score and MELD score remained stable. Bacterial peritonitis episodes were higher at 12 months (3 vs 9; p = 0.04). PD-related complications at one year included one omental wrap, three pericatheter leaks, and one umbilical hernia. At the 12-month follow-up, 32 patients survived. One patient died from myocardial infarction, and another experienced severe hepatic encephalopathy and aspiration pneumonia. Conclusion PD was well tolerated in patients with refractory ascites, presenting no additional hypoalbuminemia risk. Continuous multidisciplinary monitoring for malnutrition remains critical. Peritonitis risk was elevated relative to SBP in HD patients yet was on par with typical PD rates, without an increase in hospital admissions.

#1884 Slowing kidney disease with weight loss: a randomised controlled feasibility study (SLOW-CKD Feasibility Study)

Abstract Background and Aims Obesity is a modifiable risk factor for chronic kidney (CKD) and progression to kidney failure. Low energy diets (LEDs) (800 to 1000 kcal/day) are an established weight management strategy and have demonstrated the ability to facilitate 10 to 15 kg weight loss and induce diabetes remission. However, the use of LEDs in adults with CKD is limited and there have been no randomised controlled trials (RCT) exploring their use. Before initiating a definitive trial, there is first a need to assess feasibility and safety. The primary aim of this study was to test the feasibility, acceptability and safety of a low energy diet and weight management program in individuals with obesity and CKD. Method The SLOW-CKD Feasibility Study, a 6-month multi-centre RCT in kidney outpatient clinics in Brisbane Australia, targeted adults with stages 1-3 CKD and a body mass index (BMI) ≥ 30 kg m2 with proteinuria (urinary albumin to creatinine ratio &amp;gt;3 mg/mmol). Participants wererandomised (1:1). The LED group followed a 3-month LED (800-1000 kcal/day) with meal replacements and low-calorie foods, with fortnightly dietitian support. Following this, participants entered a 3-month weight maintenance phase,emphasising healthy eating and commencing a physical activity program guided by an exercise physiologist. The usual care group was offered weight loss support through the kidney clinic, involving referral to a dietitian or weight loss program if agreeable. Primary outcomes included safety (study related serious adverse events [SAEs] and adverse events [aEs]) and feasibility (recruitment rate, retention rate, target weight loss). Secondary outcomes explored changes in anthropometry and clinical measures, patient-reported outcomes, and participant experiences through semi-structured interviews. Pre-defined safety and feasibility outcome criteria are presented in Table 1. Results Overall, 49 participants consented to participate (mean age 52.4 ± 3.8 years, 57% male). The incidence of SAEs was low and comparable between the two groups. There were two SAEs in the LED group (hypoglycaemia and acute kidney injury both requiring hospital admission) and one in the control (hypoglycaemia requiring hospital admission). The most common AE was hyperkalaemia with three episodes (&amp;gt;6.0 mmol/L) in each group. Two of the three feasibility criteria were met deeming the intervention feasible—see Table 1. Mean weight loss for the initial 3-month study period was 10.6 kg ± 5.1 kg in the LED group and 0.7 kg ± 4.3 for the usual care group (p = &amp;lt;0.00). Conclusion Our findings provide important preliminary evidence that LEDs are relatively safe, feasible, and demonstrate promising efficacy as a treatment option for obesity in adults with CKD. A definitive RCT exploring the use of LEDs to improve clinical outcomes and slow progression of CKD is warranted.

Complementary Thoracic Endovascular Aortic Repair (TEVAR) after Frozen Elephant Trunk for Residual Type A Aortic Dissection: Perioperative and Mid-Term Outcomes.

Objectives: The aim of this retrospective study was to evaluate the results of complementary TEVAR following the frozen elephant trunk (FET) procedure for patients with residual type A aortic dissection (rTAAD) in terms of technical feasibility, safety and mid-term outcomes. Methods: This was a retrospective single-centre analysis of patients who received TEVAR after FET for rTAAD from January 2012 up to December 2021. The primary endpoint was technical success. Safety parameters included 30-day/in-hospital morbidity and mortality. Furthermore, mid-term clinical and morphological outcomes were evaluated. Results: Among 587 TEVAR procedures, 60 patients (11 with connective tissue disorders) who received TEVAR after FET for rTAAD were identified. The median interval between FET and TEVAR was 28.5 months. Indications for TEVAR after FET were true lumen collapse distal to FET prosthesis (n = 7), dSINE (n = 2), planned completion (n = 13) and aortic diameter progression (n = 38). In forty-seven patients, TEVAR was performed in an elective setting; eight and six patients were operated on in an urgent or emergency setting, respectively. All TEVAR procedures were successfully completed. The 30-day mortality and spinal cord ischemia rates were 1.7%. During a median follow-up of 37 months, two further patients died. Nine patients had to undergo a further aortic intervention: fenestrated stent-graft (n = 3) or open repair of the infrarenal abdominal aorta (n = 6). Conclusions: Complementary TEVAR following FET for rTAAD showed excellent technical success and low perioperative risk, supporting the feasibility and safety of this strategy. Despite the favourable mid-term survival, certain patients might require a further aortic procedure.

A Web-Based Intervention for Insufficiently Active College Students: Feasibility and Preliminary Efficacy.

One third of college students do not achieve aerobic activity levels recommended for physical and mental health. The web-based "I Can Be Active!" intervention was designed to help college students increase their physical activity. The intervention was grounded in the Multi-Process Action Control (M-PAC) framework which emphasizes translating intention into sustainable action. The primary purpose was to evaluate the feasibility of the intervention with insufficiently active young adult college students. The secondary purposes were to describe the preliminary effects of the intervention on: (1) the M-PAC constructs and (2) physical activity. Twenty-one college students, ages 18 to 24, were enrolled in the pre-post quasi-experimental study to test the 8-week intervention during Spring 2021. Data were collected via self-report questionnaires, web-analytics, and interviews. Feasibility outcomes included recruitment, retention, acceptability, practicality, and implementation. Preliminary efficacy outcomes were self-report M-PAC constructs and physical activity. Data analyses included descriptive statistics, t tests, Wilcoxon signed rank tests, Hedge's g, and thematic analysis. Recruitment and retention rates were 70% and 71%, respectively. Participants reacted positively to the program, content, and features, except the manual entry step tracker and private social media group. Positive trends and significant increases were found in the regulatory and reflexive M-PAC constructs (self-regulation, habit, and identity) and physical activity. Findings support the feasibility and preliminary effects of the intervention for insufficiently active college students and highlight implications for intervention refinement. Future research will test intervention effectiveness using a randomized controlled trial with a larger diverse sample of college students.

Multicomponent Intervention on Improving the Cognitive Ability of Older Adults with Mild Cognitive Impairment: A Pilot Randomized Controlled Trial

ABSTRACT This pilot randomized controlled trial aimed to evaluate the feasibility and potential outcomes of an innovative 16-session multicomponent intervention model to improve cognitive abilities in older adults with mild cognitive impairment (MCI) by promoting healthy lifestyle, cognitive skills, tai chi and mindfulness practices. This study was a multicentre, randomized controlled, two-arm, parallel-group, unblinded trial in Hong Kong. 57 Chinese older adults with MCI recruited from three local elderly centers were randomly assigned to either the control or intervention group. The study results support the feasibility and efficacy of the multicomponent intervention, and recommend future larger-scale randomized control trials.