Multicenter Feasibility Study Research Articles

Imaging blood-brain barrier dysfunction in drug-resistant epilepsy: A multi-center feasibility study.

Blood-brain barrier dysfunction (BBBD) has been linked to various neurological disorders, including epilepsy. This study aims to utilize dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) to identify and compare brain regions with BBBD in patients with epilepsy (PWE) and healthy individuals. We scanned 50 drug-resistant epilepsy (DRE) patients and 58 control participants from four global specialized epilepsy centers using DCE-MRI. The presence and extent of BBBD were analyzed and compared between PWE and healthy controls. Both greater brain volume and higher number of brain regions with BBBD were significantly present in PWE compared to healthy controls (p < 10-7). No differences in total brain volume with BBBD were observed in patients diagnosed with either focal seizures or generalized epilepsy, despite variations in the affected regions. Overall brain volume with BBBD did not differ in PWE with MRI-visible lesions compared with non-lesional cases. BBBD was observed in brain regions suspected to be related to the onset of seizures in 82% of patients (n = 39) and was typically identified in, adjacent to, and/or in the same hemisphere as the suspected epileptogenic lesion (n = 10). These findings are consistent with pre-clinical studies that highlight the role of BBBD in the development of DRE and identify microvascular stabilization as a potential therapeutic strategy.

Feasibility of a Multimodal Prehabilitation Program Before Elective Knee and Hip Arthroplasty in Older Adults

ObjectivesHip osteoarthritis and knee osteoarthritis cause significant disability and pain in older adults, often leading to hip or knee replacement surgery. Prehabilitation programs have been established for these surgeries, but there are few programs for orthogeriatrics. We evaluated the feasibility of a new multimodal prehabilitation program (MPP) for older adults before hip or knee replacement due to arthrosis: the Prehabilitation for Os (PRE4OS) study. DesignWe conducted a multicenter feasibility study in the Greater Paris area. Setting and ParticipantsEligible adults were ≥75 years old awaiting hip or knee replacement with at least a 6-week delay before surgery and able to participate in the MPP follow-up. The MPP included weekly hospital sessions providing nutritional, psychological, functional, and cognitive support, along with weekly home sessions featuring physiotherapist visits. MethodsThe primary outcome was at least 80% of 1-day hospital (ODH) sessions performed by 80% of participants. Secondary outcomes included intervention achievement, quality of life, and nutritional and functional status changes. Participant's satisfaction was qualitatively assessed via structured phone interviews presurgery and at 30 days postsurgery. ResultsFrom September 2021 to September 2023, a total of 27 individuals participated in the PRE4OS study. The mean (SD) age was 83 (4.3) years, with 7 males (26%) and median baseline Activities of Daily Living score 5.5 (interquartile range 5.5–6.0). Surgeries were for insertion of hip prosthesis in 17 participants (63%) and knee prosthesis in 10 (37%). The primary outcome was achieved in 89% of participants, with comparable rates for hip and knee prostheses. In total, 60% of participants rated the MPP as “excellent” presurgery and 100% at 30 days postsurgery, expressing a willingness to recommend the protocol to a friend or family. Conclusion and ImplicationsThe MPP was feasible for individuals before hip or knee replacement and was well received. Further randomized trials are needed to assess its clinical impact.

O12 MULTI-centre feasibility study to assess the use of 99m Tc-sestaMIBI SPECT/CT in the diagnosis of kidney tumours (MULTI-MIBI study)

O12 MULTI-centre feasibility study to assess the use of 99m Tc-sestaMIBI SPECT/CT in the diagnosis of kidney tumours (MULTI-MIBI study)

Screening for pulmonary hypertension in pregnant women with sickle cell disease in sub-Saharan Africa

BackgroundSickle cell disease (SCD) has evolved from a condition predominantly fatal in childhood to a chronic illness impacting many adults, including women of reproductive age. For females with SCD, pregnancy represents one of the greatest health threats, exacerbating existing health challenges and introducing new risks. Despite advancements in healthcare, routine screening for existing complications like pulmonary hypertension (PH) remains inconsistent, particularly in low- and middle-income countries (LMICs), where the prevalence of SCD is highest. ObjectiveThis study aimed to assess the feasibility of screening for PH in pregnant women with SCD in LMICs, with the goal of enhancing maternal health outcomes in this vulnerable population. Study DesignA prospective multi-center feasibility study was conducted from September 2022 to February 2023 at teaching hospitals in Ghana and Nigeria. The study included pregnant women with SCD between 28 and 34 weeks of gestation. Screening for PH utilized a tricuspid regurgitation velocity (TRV) criterion (>2.5 m/s), with adherence to American Society of Echocardiography guidelines. Statistical analysis included descriptive statistics and proportions. ResultsAmong 3091 pregnant women attending antenatal care, 88 had SCD (2.8%), and 55 were eligible for the study. We recruited 44 participants (mean age 28.9 years, SD 4.8), with 48% (21/44) SS genotype and 52% (23/44) SC genotype. Most participants (95.3%) had normal TRV (<2.5 m/s), with only one showing elevated TRV, successfully referred. Protocol adherence was 100%. Antenatal outcomes showed 95% echo uptake and 95.7% retention to term whilst postnatal echo follow-up was 43.5%. Notably, 27.1% (10/37) of deliveries required neonatal intensive care unit admission, and 18.2% were preterm. The sole participant with PH required intensive care unit care and experienced a preterm delivery with neonatal death on day 5. ConclusionScreening and referral for PH in pregnant women with SCD in LMICs are feasible but face challenges in early diagnosis, healthcare personnel availability, and postnatal follow-up. Strategic planning is crucial to address these challenges and improve outcomes in this high-risk population

The Minimal assessment Protocol for Cerebral Stroke 2020 (PMIC2020): a multicenter feasibility study in post-stroke inpatient rehabilitation.

In 2008, a Working Group of the Italian Society of Physical and Rehabilitation Medicine (SIMFER) published the first minimum protocol for assessing stroke patients (PMIC) to define functional needs and outcomes. The recent PMIC revision (PMIC2020) introduces a document for all rehabilitation settings, incorporating updated measurement tools. The aim of this study was to investigate the PMIC2020 feasibility and administration time (AT) in post-stroke inpatients and to examine the influence of demographic and clinical variables on AT. Multicenter prospective observational study. Eight Italian rehabilitation centers for post-acute inpatients. Adult patients consecutively admitted to rehabilitation after ischemic/hemorrhagic stroke, reporting the first event or recurrence, with a modified Barthel Index (mBI)<75 points, without cognitive impairment and clinical instability. PMIC2020 was administered at admission (T0) and discharge (T1), recording AT of each section/ tool. A feasibility questionnaire was administered to assessors. Univariate and multivariate analyses were conducted to investigate the effect of demographics and clinical variables on AT. One hundred fifty-one subjects were enrolled at T0 and 139 at T1; the mean±SD AT (seconds) was 1634±401 at T0 and 1087±360 at T1 (P<0.001). National Institute of Health-Stroke Scale and Mini-Mental State Examination required the highest AT. All but two scales had significantly lower AT at T1 (P<0.05). Severe disability (as measured by mBI) was associated with higher AT than either complete or minimal/absent disability. The feasibility questionnaire showed good PMIC2020 appraisal by assessors without relevant critical issues. PMIC2020 was feasible in post-acute inpatient rehabilitation settings. No relevant critical issue was raised by users. Even though more comprehensive than PMIC, PMIC2020 required only slightly more AT (27 minutes at T0 and 18 minutes at T1, on average); more AT was needed to assess patients with severe disability. The study has immediate transferability for the National Health Service, as PMIC2020 can be routinely implemented in clinical practice and research to assess stroke patients' needs and outcomes. The updated measures allow more immediate comparisons with international data on stroke rehabilitation. Future research should investigate the PMIC2020 feasibility in other rehabilitation settings and its relevance in predicting stroke rehabilitation needs and outcomes.

FERN: is it possible to conduct a randomised controlled trial of intervention or expectant management for early-onset selective fetal growth restriction in monochorionic twin pregnancy – protocol for a prospective multicentre mixed-methods feasibility study

IntroductionSelective fetal growth restriction (sFGR) in monochorionic twin pregnancy, defined as an estimated fetal weight (EFW) of one twin <10th centile and EFW discordance ≥25%, is associated with stillbirth and...

An International, Multicenter Feasibility Study on Active and Continuous Irrigation With Cerebrospinal Fluid Exchange for Improving Outcomes in Cerebral Ventriculitis.

Cerebral ventriculitis remains a challenging neurosurgical condition because of poor outcomes including mortality rates of nearly 80% and a prolonged course of treatment in survivors. Despite current conventional management, outcomes in some cases remain unsatisfactory, with no definitive therapeutic guidelines. This feasibility study aims to explore the use of a novel active, continuous irrigation and drainage system (IRRAflow [IRRAS AB]) combined with intraventricular drug delivery for patients with cerebral ventriculitis. We conducted a multicenter, international, retrospective study of patients with ventriculitis who were treated with use of the IRRAflow system. Data collected included patient demographics, comorbidities, admission Glasgow Coma Scale score, baseline modified Rankin Scale (mRS) score, and imaging findings. Catheter occlusions, infections, and shunt placement were recorded for outcome assessment, along with discharge mRS scores and in-hospital deaths. Four centers contributed data for a total of 21 patients who had IRRAflow placement for treatment of ventriculitis. Thirteen (61.9%) were men (mean age = 49.8 ± 14.87 years). The median baseline mRS score was 1. The median Glasgow Coma Scale score at admission was 13. The etiology of ventriculitis was iatrogenic in 12 (57.1%) patients and secondary to an abscess in 9 (42.9%). No cases reported hemorrhage or failure of IRRAflow placement. Antibiotics were administered through the IRRAflow system in 13 (61.9%) cases in addition to systemic dosing. Sixteen (76.2%) patients had significant clinical improvement and resolution of ventriculitis. Seven (33.3%) patients required shunt placement after resolution because of persistent hydrocephalus. There were 6 (28.6%) in-hospital deaths. The use of active irrigation with drainage for continuous delivery of intraventricular irrigation fluid with antibiotics led to dramatically low mortality. In our case series, it led to a marked improvement in neurological status, imaging findings, and cerebrospinal fluid profiles, making it a technically feasible and safe treatment for ventriculitis.

PET-CT-guided, symptom-based, patient-initiated surveillance versus clinical follow-up in head neck cancer patients (PETNECK2): study protocol for a multicentre feasibility study and non-inferiority, randomised, phase III trial

BackgroundApproximately 40% of treated head and neck cancer (HNC) patients develop recurrence. The risk of recurrence declines with time from treatment. Current guidelines recommend clinical follow-up every two months for the first two years after treatment, with reducing intensity over the next three years. However, evidence for the effectiveness of these regimes in detecting recurrence is lacking, with calls for more flexible, patient-centred follow-up strategies.MethodsPETNECK2 is a UK-based multi-centre programme examining a new paradigm of follow-up, using positron emission tomography-computed tomography (PET-CT)-guided, symptom-based, patient-initiated surveillance. This paradigm is being tested in a unblinded, non-inferiority, phase III, randomised controlled trial (RCT). Patients with HNC, one year after completing curative intent treatment, with no clinical symptoms or signs of loco-regional or distant metastasis will be randomised using a 1:1 allocation ratio to either regular scheduled follow-up, or to PET-CT guided, patient-initiated follow-up. Patients at a low risk of recurrence (negative PET-CT) will receive a face-to-face education session along with an Information and Support (I&S) resource package to monitor symptoms and be in control of initiating an urgent appointment when required. The primary outcome of the RCT is overall survival. The RCT also has an in-built pilot, a nested QuinteT Recruitment Intervention (QRI), and a nested mixed-methods study on patient experience and fear of cancer recurrence (FCR). An initial, single-arm feasibility study has been completed which determined the acceptability of the patient-initiated surveillance intervention, the completion rates of baseline questionnaires, and optimised the I&S resource prior to implementation in the RCT.DiscussionWe hypothesise that combining an additional 12-month post-treatment PET-CT scan and I&S resource will both identify patients with asymptomatic recurrence and identify those at low risk of future recurrence who will be empowered to monitor their symptoms and seek early clinical follow-up when recurrence is suspected. This change to a patient-centred model of care may have effects on both quality of life and fear of cancer recurrence.Trial registrationISRCTN: 13,709,798; 15-Oct-2021.

A prospective multicenter feasibility study of a miniaturized implantable continuous flow ventricular assist device in smaller children with heart failure

There is no FDA-approved left ventricular assist device (LVAD) for smaller children permitting routine hospital discharge. Smaller children supported with LVADs typically remain hospitalized for months awaiting heart transplant-a major burden for families and a challenge for hospitals. We describe the initial outcomes of the Jarvik 2015, a miniaturized implantable continuous flow LVAD, in the NHLBI-funded Pumps for Kids, Infants, and Neonates (PumpKIN) study, for bridge-to-heart transplant. Children weighing 8 to 30 kg with severe systolic heart failure and failing optimal medical therapy were recruited at 7 centers in the United States. Patients with severe right heart failure and single-ventricle congenital heart disease were excluded. The primary feasibility endpoint was survival to 30 days without severe stroke or non-operational device failure. Of 7 children implanted, the median age was 2.2 (range 0.7, 7.1) years, median weight 10 (8.2 to 20.7) kilograms; 86% had dilated cardiomyopathy; 29% were INTERMACS profile 1. The median duration of Jarvik 2015 support was 149 (range 5 to 188) days where all 7 children survived including 5 to heart transplant, 1 to recovery, and 1 to conversion to a paracorporeal device. One patient experienced an ischemic stroke on day 53 of device support in the setting of myocardial recovery. One patient required ECMO support for intractable ventricular arrhythmias and was eventually transplanted from paracorporeal biventricular VAD support. The median pump speed was 1600 RPM with power ranging from 1-4 Watts. The median plasma free hemoglobin was 19, 30, 19 and 30 mg/dL at 7, 30, 90 and 180 days or time of explant, respectively. All patients reached the primary feasibility endpoint. Patient-reported outcomes with the device were favorable with respect to participation in a full range of activities. Due to financial issues with the manufacturer, the study was suspended after consent of the eighth patient. The Jarvik 2015 LVAD appears to hold important promise as an implantable continuous flow device for smaller children that may support hospital discharge. The FDA has approved the device to proceed to a 22-subject pivotal trial. Whether this device will survive to commercialization remains unclear because of the financial challenges faced by industry seeking to develop pediatric medical devices. (Supported by NIH/NHLBI HHS Contract N268201200001I, clinicaltrials.gov 02954497).

Remote programming in stage I sacral neuromodulation: a multicentre prospective feasibility study.

Sacral neuromodulation (SNM) has emerged as an effective therapy for refractory lower urinary tract dysfunction (LUTD). Remote programming holds promise in addressing the time and economic burdens associated with outpatient programming, especially for patients in the observation period following Stage I implant surgery (where the lead is implanted first without the pulse generator). The study aimed to explore the effectiveness and patient satisfaction of remote programming for Stage I SNM patients, and analyze the benefits patients gain from remote programming. This prospective study was conducted at multiple high-level clinical SNM centres in China. Patients requiring SNM implantation were enroled and divided into two groups based on patient preference: remote programming (RP) group and outpatient control (OC) group. Patient attitudes toward RP were assessed through questionnaires, and the degree of symptom improvement was compared between the two groups to explore the usability of RP. A total of 63 participants from 6 centres were included in the study, with 32 belonging to the RP group. The remote programming system presents a high level of usability (98%) and willingness (satisfaction rate: 96.83%) in result of questionnaire. RP showed a significant advantage in improving patients' score of ICSI/ICPI (medianΔICSI/ICPI RP vs. OC= -13.50 vs -2, P =0.015). And slightly ameliorate urinary symptoms such as pain (medianΔVAS RP vs. OC= -1 vs 0, P = 0.164) and urgency (medianΔOBASS -2.5 vs. -1, P = 0.,229), but the difference was not statistically significant. RP did not significantly impact the quality of life of patients ( P =0.113), so do the rate of phase-two conversion ( P = 0.926) or programming parameters. To the best of our knowledge, the presented study is the first multicenter research focusing on the remote programming of Stage I SNM patients. Through the clinical implementation and patient feedback, we demonstrate that remote programming is not inferior to in-person programming in terms of success rate, effectiveness, safety, and patient satisfaction.

First-in-human feasibility study of the aXess graft (aXess-FIH): 6-Month results.

The creation of an arteriovenous fistula (AVF) is considered the most effective hemodialysis (HD) vascular access. For patients who are not suitable for AVF, arteriovenous grafts (AVGs) are the best access option for chronic HD. However, conventional AVGs are prone to intimal hyperplasia, stenosis, thrombosis, and infection. Xeltis has developed an AVG as a potential alternative to currently available AVGs based on the concept of endogenous tissue restoration. The results of the first 6-month follow-up are presented here. The aXess first-in-human (FIH) study [NCT04898153] is a prospective, single-arm, multicenter feasibility study that evaluates the early safety and performance of the aXess Hemodialysis Graft. A total of 20 patients with end-stage renal disease were enrolled across six European investigational sites. At 6-months follow-up, all grafts were patent with primary and secondary patency rates were 80% and 100%, respectively. Three patients required a re-intervention to maintain graft patency, while one re-intervention was required to restore patency. One graft thrombosis and zero infections were reported. The expected advantages of the novel aXess Hemodialysis Graft over conventional AVGs would be evaluated by the analysis on long-term safety and effectiveness during the 5-year follow-up of the currently ongoing trial.

Multisegmented esophageal fully covered self-expandable metal stent for palliation of malignant dysphagia: a prospective, multicenter feasibility and safety study

A novel multisegmented esophageal fully covered self-expandable metal stent (FCSEMS) was designed to reduce stent migration, which is seen in up to 30% of patients. The goal of this study was to evaluate the safety and efficacy of the multisegmented FCSEMS. This multicenter prospective study aimed to include 30 patients undergoing palliative stent placement. Efficacy, defined as technically successful stent placement and dysphagia scores, and safety, defined as the number of adverse events (AEs) and serious AEs (SAEs), were measured. The study was prematurely terminated due to safety concerns after including 23 patients (mean ± standard deviation age, 72 ± 10 years; 78% male). Stent placement was technically successful in 21 patients (91%), and dysphagia scores had improved in all patients with successful stent placement. SAEs were reported in 16 (70%) patients. Stent-related mortality occurred in 3 patients (13%). The multisegmented FCSEMS successfully treated malignant dysphagia. The study was prematurely terminated, however, because stent placement was associated with a relatively high SAE rate. (Clinical trial registration number: NCT04415463.).

Endoscopic resection for esophageal gastrointestinal stromal tumors: a multi-center feasibility study

Background: Esophageal gastrointestinal stromal tumors (E-GISTs) are highly uncommon and have not been thoroughly examined. Objectives: The objective of this multi-center study was to assess the viability of endoscopic resection (ER) in the treatment of E-GISTs and to explore its clinical implications. Design: This was a multi-center retrospective study. Consecutive patients referred to the four participating centers. Methods: E-GISTs among the consecutive subepithelial tumors (SETs) treated by ER methods were enrolled from April 2019 to August 2022. Clinicopathological, endoscopic, and follow-up data were collected and analyzed. Results: A total of 23 patients with E-GISTs were included for analysis, accounting for 1.9% of all the esophageal SETs (1243 patients). The average size of the tumor lesions was 2.3 cm (range 1.0–4.0 cm). We observed that tumors larger than 2.0 cm were more likely to grow deeper, with a statistically significant difference ( p &lt; 0.001). End bloc resection was achieved in all 23 patients. The mean operation time was 53.6 min (range 25–111 min). One patient experienced significant intraoperative bleeding, which was promptly managed endoscopically without necessitating surgery. The average hospital stay was 4.5 days (range 3–8 days). The overall median follow-up period was 31 months (range 13–47 months). No tumor recurrence, residual tumor, distal metastasis, or death was observed during the follow-up period. Conclusion: Based on our limited data, our study indicates that ER may be a feasible and effective option for treating esophageal GISTs measuring 4 cm or less. We suggest submucosal tunnel endoscopic resection as the preferred approach, as all E-GISTs in our study were situated in the muscularis propria layer. Additionally, tumors larger than 2 cm were more prone to deeper growth or extraluminal extension.

Detecting Stroke at the Emergency Department by a Point of Care Device: A Multicenter Feasibility Study.

To evaluate if the Strokefinder MD 100 by Medfield Diagnostics AB can be used as a point of care device in overcrowded Emergency Departments (ED). We used the strokefinder MD 100 by Medfield Diagnostics AB in two Greek National Health System (NHS) Hospitals Emergency Departments. Our research protocol was approved by local scientific and ethics committees. We prospectively enrolled 71 adult patients from two NHS emergency departments in whom stroke was included as a differential diagnosis after triage. The feasibility of using the Strokefinder MD 100 by Medfield Diagnostics AB in various emergency department settings was evaluated through a structured questionnaire. The strokefinder MD 100 was used on 71 patients in various settings in the Emergency Department. In every case, the test was completed at the patient bedside without interfering with other ongoing and diagnostic and resuscitation procedures. There was no additional delay to patient care caused by performing the test when compared with current local Emergency Department practice and protocol. In almost 90% of the cases, a clear result was produced by the device. The Strokefinder MD 100 can be safely used as a point of care device by all trained healthcare professionals, in the most overcrowded emergency department, in various ED locations. Point of Care Systems, Cerebrovascular Stroke, Proof of Concept Study.

EMDR in older adults with PTSD and comorbid personality disorders

Objectives:Approximately one third of older adults (≥ 60 years) with a posttraumatic stress disorder (PTSD) also suffer from a comorbid personality disorder. Emerging evidence shows that in Eye Movement Desensitization and Reprocessing (EMDR) therapy can be beneficial for personality disorders. Since personality disorders are associated with several adverse events, the present study aims to investigate whether EMDR in older adults with PTSD will improve personality functioning.Methods:A multi-center feasibility study was conducted with 24 older PTSD-patients (60-83 years). PTSD was assessed with the Clinician-Administered PTSD Scale-5 (CAPS-5). All participants received weekly 1-hour sessions of EMDR therapy for PTSD up to a maximum of 9 months. The primary outcome was change in personality dysfunction, assessed by Severity Indices of Personality Problems–Short Form (SIPP-SF) at baseline and end of treatment. Secondary outcome was pre-post difference in the presence of (any) personality disorder according to DSM-IV criteria as measured with the Structured Clinical Interview for DSM-IV Axis-II PDs (SCID-II). All analyses were adjusted for PTSD severity, therapy duration, and other treatment (co-interventions) which was kept constant.Results:A linear mixed model approach showed an increase in SIPP-SF scores from pre- to posttreatment, a significant influence of pre-post CAPS-5 for the total sample (F(1,37.5)=6.95), p=.012) and a marginal significant effect of other treatment (F(1,21.9)=4.04), p=.057). No significant main effects of time, therapy duration (3, 6, or 9 months), CAPS-5 by time was found (all p&gt;.05).Conclusions:EMDR treatment resulted in improved personality functioning. Other treatment next to EMDR had a negative impact on the increased of personality functioning.

O04 - A MULTI-centre feasibility study to assess the use of 99m Tc-sestaMIBI SPECT/CT in the diagnosis of kidney tumours (MULTI-MIBI study)

O04 - A MULTI-centre feasibility study to assess the use of 99m Tc-sestaMIBI SPECT/CT in the diagnosis of kidney tumours (MULTI-MIBI study)

Supervised Home-Based Exercise Prehabilitation in Unfit Patients Scheduled for Pancreatic Surgery: Protocol for a Multicenter Feasibility Study.

Morbidity rates in pancreatic surgery are high, and frail patients with low aerobic capacity are especially at risk of complications and require prophylactic interventions. Previous studies of small patient cohorts receiving intra-abdominal surgery have shown that an exercise prehabilitation program increases aerobic capacity, leading to better treatment outcomes. In this study, we aim to assess the feasibility of a home-based exercise prehabilitation program in unfit patients scheduled for pancreatic surgery on a larger scale. In this multicenter study, adult patients scheduled for elective pancreatic surgery with a preoperative oxygen uptake (VO2) at the ventilatory anaerobic threshold ≤13 mL/kg/min or a VO2 at peak exercise ≤18 mL/kg/min will be recruited. A total of 30 patients will be included in the 4-week, home-based, partly supervised exercise prehabilitation program. The program comprises 25-minute high-intensity interval training on an advanced cycle ergometer 3 times a week. Training intensity will be based on steep ramp test performance (ie, a short-term maximal exercise test on a cycle ergometer), aiming to improve aerobic capacity. Twice a week, patients will perform functional task exercises to improve muscle function and functional mobility. A steep ramp test will be repeated weekly, and training intensity will be adjusted accordingly. Next to assessing the feasibility (participation rate, reasons for nonparticipation, adherence, dropout rate, reasons for dropout, adverse events, and patient and therapist appreciation) of this program, individual patients' responses to prehabilitation on aerobic capacity, functional mobility, body composition, quality of life, and immune system factors will be evaluated. Recruitment for this study began in January 2022 and is expected to be completed in the summer of 2023. Results of this study will provide important clinical and scientific knowledge on the feasibility of a partly supervised home-based exercise prehabilitation program in a vulnerable patient population. This might ease the path to implementing prehabilitation programs in unfit patients undergoing complex abdominal surgery, such as pancreatic surgery. ClinicalTrials.gov NCT05496777; https://classic.clinicaltrials.gov/ct2/show/NCT05496777. DERR1-10.2196/46526.

M-RESIST, a Mobile Therapeutic Intervention for Treatment-Resistant Schizophrenia: Feasibility, Acceptability, and Usability Study

Background In the European Union, around 5 million people are affected by psychotic disorders, and approximately 30%-50% of people with schizophrenia have treatment-resistant schizophrenia (TRS). Mobile health (mHealth) interventions may be effective in preventing relapses, increasing treatment adherence, and managing some of the symptoms of schizophrenia. People with schizophrenia seem willing and able to use smartphones to monitor their symptoms and engage in therapeutic interventions. mHealth studies have been performed with other clinical populations but not in populations with TRS. Objective The purpose of this study was to present the 3-month prospective results of the m-RESIST intervention. This study aims to assess the feasibility, acceptability, and usability of the m-RESIST intervention and the satisfaction among patients with TRS after using this intervention. Methods A prospective multicenter feasibility study without a control group was undertaken with patients with TRS. This study was performed at 3 sites: Sant Pau Hospital (Barcelona, Spain), Semmelweis University (Budapest, Hungary), and Sheba Medical Center and Gertner Institute of Epidemiology and Health Policy Research (Ramat-Gan, Israel). The m-RESIST intervention consisted of a smartwatch, a mobile app, a web-based platform, and a tailored therapeutic program. The m-RESIST intervention was delivered to patients with TRS and assisted by mental health care providers (psychiatrists and psychologists). Feasibility, usability, acceptability, and user satisfaction were measured. Results This study was performed with 39 patients with TRS. The dropout rate was 18% (7/39), the main reasons being as follows: loss to follow-up, clinical worsening, physical discomfort of the smartwatch, and social stigma. Patients’ acceptance of m-RESIST ranged from moderate to high. The m-RESIST intervention could provide better control of the illness and appropriate care, together with offering user-friendly and easy-to-use technology. In terms of user experience, patients indicated that m-RESIST enabled easier and quicker communication with clinicians and made them feel more protected and safer. Patients’ satisfaction was generally good: 78% (25/32) considered the quality of service as good or excellent, 84% (27/32) reported that they would use it again, and 94% (30/32) reported that they were mostly satisfied. Conclusions The m-RESIST project has provided the basis for a new modular program based on novel technology: the m-RESIST intervention. This program was well-accepted by patients in terms of acceptability, usability, and satisfaction. Our results offer an encouraging starting point regarding mHealth technologies for patients with TRS. Trial Registration ClinicalTrials.gov NCT03064776; https://clinicaltrials.gov/ct2/show/record/NCT03064776 International Registered Report Identifier (IRRID) RR2-10.1136/bmjopen-2017-021346

Usability of a digital health platform to support home hospitalization in heart failure patients: a multicentre feasibility study among healthcare professionals.

Heart failure (HF) is a common cause of mortality and (re)hospitalizations. The NWE-Chance project explored the feasibility of providing hospitalizations at home (HH) supported by a newly developed digital health platform. The aim of this study was to explore the perceived usability by healthcare professionals (HCPs) of a digital platform in addition to HH for HF patients. A prospective, international, multicentre, single-arm interventional study was conducted. Sixty-three patients and 22 HCPs participated. The HH consisted of daily home visits by the nurse and use of the platform, consisting of a portable blood pressure device, weight scale, pulse oximeter, a wearable chest patch to measure vital signs (heart rate, respiratory rate, activity level, and posture), and an eCoach for the patient. Primary outcome was usability of the platform measured by the System Usability Scale halfway and at the end of the study. Overall usability was rated as sufficient (mean score 72.1 ± 8.9) and did not differ between the measurements moments (P = 0.690). The HCPs reported positive experiences (n = 7), negative experiences (n = 13), and recommendations (n = 6) for the future. Actual use of the platform was 79% of the HH days. A digital health platform to support HH was considered usable by HCPs, although actual use of the platform was limited. Therefore, several improvements in the integration of the digital platform into clinical workflows and in defining the precise role of the digital platform and its use are needed to add value before full implementation. clinicaltrials.gov NCT04084964.

A multicenter feasibility study on implementing a brief mindful breathing exercise into regular university courses

Practicing mindfulness is associated with stress reduction and with positive effects in the context of learning and teaching. Although effects on student populations have been studied extensively, there are few studies implementing mindfulness exercises in university courses directly. For this reason, we aimed to investigate whether the use of a brief mindfulness exercise in regular university courses, guided by the lecturers, is feasible and has immediate effects on the students’ mental states. We conducted a preregistered multicenter study with one observational arm, following an ABAB design. In total, N = 325 students from 19 different university courses were included at baseline and n = 101 students at post measurement. Students were recruited by N = 14 lecturers located in six different universities in Germany. Lecturers started their courses either by guiding a brief mindfulness exercise (intervention condition) or as they regularly would, with no such exercise (control condition). In both conditions, the mental states of students and lecturers were assessed. Over the semester, n = 1193 weekly observations from students and n = 160 observations from lecturers were collected. Intervention effects were analyzed with linear mixed-effects models. The brief mindfulness exercise, compared to no such exercise, was associated with lower stress composite scores, higher presence composite scores, higher motivation for the courses, as well as better mood in students. Effects persisted throughout a respective course session. Lecturers also reported positive effects of instructing mindfulness. Implementing a brief mindfulness exercise in regular university teaching sessions is feasible and has positive effects on both students and lecturers.