Primary Clinical Outcome Measure Research Articles

Anterior Cruciate Ligament Reconstruction With The Rectus Femoris Autograft – Results From The First 80 Patients

Objectives To report on the clinical outcomes and complications following anterior cruciate ligament (ACL) reconstruction using a novel rectus femoris autograft, including its clinical efficacy and safety. Methods Retrospective case series of patients undergoing isolated primary anatomic ACL reconstruction, with an outside-in technique, using a novel a rectus femoris autograft. Non-inclusion criteria consisted of partial tears; prior ipsilateral knee surgery; concomitant ligament, meniscus or cartilage procedures; follow-up shorter than 6 months. The primary clinical outcome measure was Lysholm score, including the percentage of patients achieving a previously published patient acceptable symptom state (PASS). Secondary outcomes included the observed rates for complications, as well as graft failure rate. Results 80 patients (53% male; mean age 28.95 ± 8,04 years) were included, with a mean follow up of 18.03 months (± 6,94; min 6, max 28). The mean postoperative Lysholm was 97.08 (± 2.63; min 90, max 100), with 100% of patients achieving PASS. There were three instances of graft amputation during harvest (3/83 = 3.61%), all of which occurred within the first 10 cases. An overall post-operative complication rate of 6.25% was observed, with 4 instances of hematoma at the graft harvest site (4/80 = 5%), one infection (1/80 = 1.25%) and no instances of graft failure (0/80 = 0%) at final follow-up. Conclusion The rectus femoris autograft is a suitable graft option for ACL reconstruction, with demonstrated clinical efficacy and safety in this initial case series. Potential benefits include a minimally invasive harvest technique without the need for additional instruments, and an observed length of around 30cm, which can be tailored to multiligament or revision cases. Longer follow-up and comparative studies are needed in the future in order to assess the long-term efficacy and failure rates.

Effectiveness of specialist involvement in case discussion conferences with primary healthcare providers on the management of type 2 diabetes patients: a study protocol for a cluster randomized controlled trial

BackgroundIn supporting primary healthcare in delivering high-quality care for individuals with type 2 diabetes mellitus (T2DM), previous research emphasized strategies to facilitate communication and collaboration between primary healthcare providers and hospitals. This study aims to evaluate the effectiveness of case discussion conferences between specialists from hospitals and primary healthcare providers in China on the optimization of diabetes management and the improvement of patient health outcomes.MethodsThis study will be a parallel cluster randomized controlled trial in which primary healthcare institutions in Shouguang city and Shangsi County will be randomly allocated to the intervention and control groups. The intervention will involve regular case discussion conferences where attendants will meet to discuss complex cases with patients diagnosed with type 2 diabetes mellitus, exchange experiences, and seek and provide expert advice. Family doctor teams from primary healthcare institutions and specialists from secondary or tertiary hospitals will engage in these conferences. Data will be collected at baseline and at the 6- and 12-month follow-ups. The primary clinical outcome measures will focus on the changes in the HbA1c and FBG levels of patients under management. The secondary outcomes will include other physiological indicators, such as blood pressure, BMI, and cholesterol. The evaluation will extend to changes in the capabilities and behaviors of primary healthcare providers. Furthermore, the feasibility and adherence of this intervention will be thoroughly assessed.DiscussionThis study is designed to generate robust evidence on the effectiveness of case discussion conferences, an interprofessional collaboration strategy, in enhancing diabetes care delivery in primary healthcare, with the ultimate goal of improving patient health outcomes.Trial registrationChinese Clinical Trial Registry ChiCTR2300078829. Registered on December 19, 2023. https://www.chictr.org.cn/showproj.html?proj=210293

A Dose-Finding, Biomarker Validation, and Effectiveness Study of Transcranial Magnetic Stimulation for Adolescents With Depression

Research and clinical application of transcranial magnetic stimulation (TMS) for adolescents with major depressive disorder (MDD) has advanced slowly. Significant gaps persist in our understanding of optimized, age-specific protocols and dosing strategies. This study aimed to compare the clinical effects of 1 Hz versus 10 Hz TMS regimens and examine a biomarker-informed treatment approach with glutamatergic intracortical facilitation (ICF). Participants with moderate-to-severe symptoms of MDD were randomized to 30 sessions of left prefrontal 1 Hz or 10 Hz TMS, stratified by baseline ICF measures. The primary clinical outcome measure was the Children's Depression Rating Scale, Revised (CDRS-R). The CDRS-R and ICF biomarker were collected weekly. Forty-one participants received either 1 Hz (n = 22) or 10 Hz (n = 19) TMS treatments. CDRS-R scores improved compared to baseline in both 1 Hz and 10 Hz groups. For participants with low ICF at baseline, the overall least squares means of CDRS-R scores over the 6-week trial showed that depressive symptom severity was lower for the group treated with 1 Hz TMS than for those who received 10 Hz TMS. There were no significant changes in weekly ICF measurements across the 6 weeks of TMS treatment. Low ICF may reflect optimal glutamatergic N-methyl-d-aspartate (NMDA) receptor activity that facilitates the therapeutic effect of 1 Hz TMS through long-term depression-like mechanisms on synaptic plasticity. The stability of ICF suggests that it is a tonic, trait-like measure of NMDA receptor-mediated neurotransmission, with potential utility to inform parameter selection for therapeutic TMS in adolescents with MDD.

Trevo 3 Mm and/or AXS Catalyst5 for the Treatment of Medium Distal Vessel Occlusion Stroke-results from the ASSIST Registry.

The effect of endovascular therapy (EVT) on the outcome of stroke patients with amedium distal vessel occlusion (MDVO) is unclear. We report the results of MDVO patients treated with the 3 mm Trevo stent retriever (SR) and/or the AXS Catalyst5 distal access catheter. Data was derived from aprospective, multicenter global registry (ASSIST registry) which enrolled patients treated with operator preferred EVT technique at 71sites from January 2019 to January 2022. Three techniques were assessed: SR classic, direct aspiration, and acombined approach. Additional inclusion criteria were (a)EVT performed with the 3 mm Trevo SR and/or AXS Catalyst5 distal access catheter on the first pass and (b)an occlusion of the M2segment or M3segment of the middle cerebral artery or the A1, A2 or A3segment of the anterior cerebral artery. The primary outcome was achieving an expanded Thrombolysis in Cerebral Infarction (eTICI) score of 2c or 3 on the first pass, with the primary technique as adjudicated by core lab. The primary clinical outcome measure was a90-day modified Rankin Scale (mRS) score of 0-2. Atotal of 155 patients (10.4% of the ASSIST population) were included. Most patients had an M2 occlusion (93.5%). First pass eTICI reperfusion was achieved in 43.1% of the patients. No modifying effect of the frontline technique was found. The rate of mRS 0-2 (overall 65.0%) did not significantly differ between groups. The data suggests that the Trevo 3 mm SR and/or the AXS Catalyst5 may be an option to treat medium distal vessel occlusion, but more data is needed to demonstrate safety and efficacy in this patient cohort. Further improvements are needed regarding materials and techniques to improve reperfusion results in this patient cohort in the future.

RTMS of the Cerebellum Using an Accelerated Stimulation Protocol Improved Gait in Parkinson’s Disease

Background Repetitive transcranial magnetic stimulation (rTMS) is a nonpharmacological and noninvasive brain stimulation technique that has been proven to be effective in Parkinson’s disease (PD). The combination of rTMS and treadmill training improved gait function in PD greater than treadmill training alone. Objective The aim of our study was to evaluate the combination of a novel high-intensity, short intervention rTMS treatment and a multimodal treatment protocol including of physiotherapy, occupational therapy and language therapy, the so-called Parkinson’s Disease Multimodal Complex Treatment (PD-MCT), to improve motor function. Methods In this randomized double-blind sham-controlled trial rTMS with 48 Hz or sham was applied over the cerebellum 3 times a day for 5 consecutive days. Patients were assessed at baseline (V0), after 5 days of treatment (V1), and 4 weeks later (V2). The primary clinical outcome measure was the motor sum-score of the Unified PD Rating Scale (UPDRSIII), secondary clinical outcomes were quantitative motor tasks. Results A total of 36 PD patients were randomly allocated either to rTMS (n = 20) or sham (n = 16), both combined with PD-MCT. rTMS improved the UDPRSIII score comparing baseline and V1 in the treatment group by −8.2 points (P = .004). The 8MW and dynamic posturography remained unchanged in both groups after intervention. Conclusion. Compressing weeks of canonical rTMS protocols into 5 days was effective and well tolerated. rTMS may serve as an add-on therapy for augmenting the multimodal complex treatment of motor symptoms, but seems to be ineffective to treat postural instability.

TWO-YEAR FOLLOW-UP OF 334 THIRD-GENERATION MINIMALLY INVASIVE CHEVRON AKIN OSTEOTOMIES (MICA) IN HALLUX VALGUS SURGERY

BackgroundThere are many different procedures described for the correction of hallux valgus deformity. Minimally invasive surgery has become increasingly popular, with clinical and radiological outcomes comparable to traditional open osteotomy approaches. There is increasing interest in hallux valgus deformity correction using third-generation minimally invasive chevron akin osteotomy (MICA) technique.ObjectiveTo assess the radiographic correction and 2 year clinical outcomes of third-generation MICA using validated outcome measures.MethodsThis is a prospective single-surgeon case series of 420 consecutive feet undergoing MICA surgery between July 2014 and November 2018. Primary clinical outcome measures included the Manchester-Oxford Foot Questionnaire (MOXFQ), EQ-5D, and the Visual Analogue Pain Scale. Secondary outcome measures included radiographic parameters, and complication rates.ResultsPre-operative and 2 year post-operative patient reported outcomes were collected for 334 feet (79.5%). At minimum 2 year follow-up, the MOXFQ scores (mean ± standard deviation (SD)) had improved for each domain: pain; pre-operative 43.9±21.0 reduced to 9.1±15.6 post-operatively (p<0.001), walking and standing; pre-operative 38.2±23.6 reduced to 6.5±14.5 post-operatively (p<0.001) and social interaction; pre-operative 47.6±22.1, reduced to 6.5±13.5 post-operatively (p<0.001). At 2 year follow-up, the VAS Pain score (mean ± SD) improved from a pre-operative of 31.3±22.4 to 8.3±16.2 post-operatively (p<0.001). 1–2 intermetatarsal angle (mean ± SD) reduced from 15.4°±3.5° to 5.8°±3.1° (p<0.001) and hallux valgus angle reduced from 33.1°±10.2° to 9.0°±5.0° post-operatively (p<0.001).ConclusionThird-generation MICA showed significant improvement in clinical outcomes at 2 year follow-up and can be successfully used for correction of a wide range of hallux valgus deformities.

Nusinersen Initiation After Onset of Weakness Does Not Prevent Progression of Hip Instability.

We report changes in the natural history of hip instability with nusinersen treatment among patients with spinal muscular atrophy (SMA) type II after onset of weakness, historically wheelchair-bound but now potentially ambulatory in the era of disease-modifying therapy. Patients with genetically confirmed diagnoses of SMA type II who received intrathecal nusinersen from January 1, 2018, to June 30, 2022, were screened for inclusion. Patients with less than 6 months of follow-up, or prior hip surgeries were excluded. Primary clinical outcome measures included scores from Hammersmith motor functional scale expanded (HMFSE), revised upper limb module (RULM), 6-minute walk test (6MWT), and ambulatory status. Radiographic outcomes, including Reimer migration index, the presence of scoliosis, and pelvic obliquity, were also assessed. Secondary outcomes involved comparisons with a historical cohort of SMA type II patients treated at our institution who never received nusinersen. Twenty hips from 5 boys and 5 girls were included in the analysis, with a mean follow-up of 3 years and 8 months. The median age at time of nusinersen initiation was 6.8 years old, ranging between 2.5 and 10.3 years. All patients developed lower limb motor weakness before nusinersen initiation. After treatment with nusinersen, 1 previously stable hip (5%) developed subluxation, 15 hips (75%) remain subluxated, 3 hips (15%) remain dislocated, and 1 hip (5%) remained stable, with a statistically significant difference between the pretreatment and posttreatment groups ( P <0.01). Six patients (60%) were ambulatory at latest follow-up. Six patients (60%) had improved ambulatory ability; 2 had static ambulatory ability (20%); and 2 had deterioration in their walking ability. The median HFMSE score improved from 18.5 (range 0 to 46) to 22 (range 0 to 49) ( P =0.813), whereas the median RULM score improved from 17 (range 2 to 28) to 21.5 (range 5 to 37), which was statistically significant ( P =0.007). Hip instability persists despite treatment with nusinersen among patients with SMA type II who received nusinersen after onset of lower limb weakness. Therapeutic Level IV.

Baseline clinical and neuroradiological predictors of outcome in patients with large ischemic core undergoing mechanical thrombectomy: A retrospective multicenter study.

Recent randomized trials have shown the benefit of mechanical thrombectomy (MT) also in patients with an established large ischemic core. The purpose of this study was to define baseline predictors of clinical outcome in patients with large vessel occlusion (LVO) in the anterior circulation and an Alberta Stroke Program Early CT score (ASPECTS) ⩽ 5, undergoing MT. The databases of 16 comprehensive stroke centers were retrospectively screened for patients with LVO and ASPECTS ⩽5 that received MT. Baseline clinical and neuroradiological features, including the differential contribution of all ASPECTS regions to the composite score, were collected. Primary clinical outcome measure was a 90-day modified Rankin Scale (mRS) score of 0-2. Statistical analysis used a logistic regression model and random forest algorithm. A total of 408 patients were available for analysis. In multivariate model, among baseline features, lower age (odd ratio (OR) = 0.962, 95% confidence interval (CI) = 0.943-0.982) and lower National Institute of Health Stroke Scale (NIHSS) score (OR = 0.911, 95% CI = 0.862-0.963) were associated with the mRS score 0-2. Involvement of the M2 (OR = 0.398, 95% CI = 0.206-0.770) or M4 (OR = 0.496, 95% CI = 0.260-0.945) ASPECTS regions was associated with an unfavorable outcome. Random forest analysis confirmed that age and baseline NIHSS score are the most important variables influencing clinical outcome, whereas involvement of cortical regions M5, M4, M2, and M1 can have a negative impact. Our retrospective analysis shows that, along with age and baseline clinical impairment, presence of early ischemic changes involving cortical areas has a role in clinical outcome in patients with large ischemic core undergoing MT. The data that support the findings of this study are available upon reasonable request.

Safety, tolerability, and efficacy estimate of evoked gamma oscillation in mild to moderate Alzheimer's disease.

Alzheimer's Disease (AD) is a multifactorial, progressive neurodegenerative disease that disrupts synaptic and neuronal activity and network oscillations. It is characterized by neuronal loss, brain atrophy and a decline in cognitive and functional abilities. Cognito's Evoked Gamma Therapy System provides an innovative approach for AD by inducing EEG-verified gamma oscillations through sensory stimulation. Prior research has shown promising disease-modifying effects in experimental AD models. The present study (NCT03556280: OVERTURE) evaluated the feasibly, safety and efficacy of evoked gamma oscillation treatment using Cognito's medical device (CogTx-001) in participants with mild to moderate AD. The present study was a randomized, double blind, sham-controlled, 6-months clinical trial in participants with mild to moderate AD. The trial enrolled 76 participants, aged 50 or older, who met the clinical criteria for AD with baseline MMSE scores between 14 and 26. Participants were randomly assigned 2:1 to receive self-administered daily, one-hour, therapy, evoking EEG-verified gamma oscillations or sham treatment. The CogTx-001 device was use at home with the help of a care partner, over 6 months. The primary outcome measures were safety, evaluated by physical and neurological exams and monthly assessments of adverse events (AEs) and MRI, and tolerability, measured by device use. Although the trial was not statistically powered to evaluate potential efficacy outcomes, primary and secondary clinical outcome measures included several cognitive and functional endpoints. Total AEs were similar between groups, there were no unexpected serious treatment related AEs, and no serious treatment-emergent AEs that led to study discontinuation. MRI did not show Amyloid-Related Imaging Abnormalities (ARIA) in any study participant. High adherence rates (85-90%) were observed in sham and treatment participants. There was no statistical separation between active and sham arm participants in primary outcome measure of MADCOMS or secondary outcome measure of CDR-SB or ADAS-Cog14. However, some secondary outcome measures including ADCS-ADL, MMSE, and MRI whole brain volume demonstrated reduced progression in active compared to sham treated participants, that achieved nominal significance. Our results demonstrate that 1-h daily treatment with Cognito's Evoked Gamma Therapy System (CogTx-001) was safe and well-tolerated and demonstrated potential clinical benefits in mild to moderate AD.Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03556280.

Technique and impact on first pass effect primary results of the ASSIST global registry

BackgroundPatients treated with mechanical thrombectomy (MT) for acute ischemic strokes from large vessel occlusion (LVO) have better outcomes with effective reperfusion. However, it is unknown which technique leads to better...

Protocol for a Pilot Study on the Neurocardiac Mechanism of an Interoceptive Compassion-Based Heart-Smile Training for Depression.

Heart-Smile Training (HST) is an interoceptive compassion-based behavioral intervention that in case reports has been beneficial for depression. Interoception refers to the awareness and regulation of physiological signals from inside the body. Depressed patients often have diminished interoceptive awareness and often experience disconnection from bodily needs and sensations. In addition to interoceptive dysfunction, depression often involves negative self-evaluation and self-critical rumination. HST is a compassion-based meditation training program that explicitly cultivates interoceptive awareness of the heart area. This study aims to investigate the possible neurocardiac mechanisms engaged through HST for depression patients. We plan to enroll 50 subjects to be randomized into a 4-week HST intervention group and a waitlist group. A battery of psychological questionnaires will be administered at baseline and post-intervention timepoints, and electroencephalography (EEG) will be collected during compassion meditation guided by pre-recorded audio. The primary clinical outcome measures are on the feasibility of the intervention and research procedures, the primary mechanistic outcome measure is the post-intervention change in Heartbeat Evoked Potential (HEP) amplitude. Secondary outcome measures include changes in depression severity and EEG gamma spectral activity. Exploratory outcome measures include effects of HST on skin conductance response, heart rate variability, EEG spectral properties in other frequency bands, as well as a list of psychological questionnaires that measure depression and anxiety symptoms, emotion regulation, mindfulness, interoceptive awareness, self-compassion, gratitude, sleep quality, quality of life and social connectedness. Results not yet available. This is the first study on the feasibility and interoceptive neurocardiac mechanism of HST. Our findings will provide frontier knowledge on the physiological working mechanism of behavioral interventions with an interoception-based meditative approach. https://clinicaltrials.gov/study/NCT05564533.

Impact of serum haemoglobin-to-creatinine ratio after transcatheter aortic valve implantation

ObjectiveThe association between a combined anaemia and renal failure index and 1-year prognosis of patients undergoing transcatheter aortic valve implantation (TAVI) is unexplored. We aimed to investigate a simple risk...

Effects of soft robotic exoskeleton for gait training on clinical and biomechanical gait outcomes in patients with sub-acute stroke: a randomized controlled pilot study.

Ankle function impairment is a critical factor impairing normal walking in survivors of stroke. The soft robotic exoskeleton (SRE) is a novel, portable, lightweight assistive device with promising therapeutic potential for gait recovery during post-stroke rehabilitation. However, whether long-term SRE-assisted walking training influences walking function and gait quality in patients following subacute stroke is unknown. Therefore, the primary objective of this study was to assess the therapeutic effects of SRE-assisted walking training on clinical and biomechanical gait outcomes in the rehabilitation of patients with subacute stroke. A group patients who had experienced subacute stroke received conventional rehabilitation (CR) training combined with 10-session SRE-assisted overground walking training (30 min per session, 5 sessions/week, 2 weeks) (SRE group, n = 15) compared with the control group that received CR training only (CR group, n = 15). Clinical assessments and biomechanical gait quality measures were performed pre-and post-10-session intervention, with the 10-Minute Walk Test (10MWT) and 6-Minute Walk Test (6MWT) used to define the primary clinical outcome measures and the Functional Ambulation Category, Fugl-Meyer Assessment for Lower Extremity (FMA-LE) subscale, and Berg Balance Scale defined the secondary outcome measures. The gait quality outcome measures included spatiotemporal and symmetrical parameters during walking. After the 10-session intervention, the SRE and CR groups exhibited significant within-group improvements in all clinical outcome measures (p < 0.05). Between-comparison using covariance analyses demonstrated that the SRE group showed greater improvement in walking speed during the 10MWT (p < 0.01), distance walked during the 6MWT (p < 0.05), and FMA-LE scores (p < 0.05). Gait analyses showed that the SRE group exhibited significantly improved spatiotemporal symmetry (p < 0.001) after 10-session training, with no significant changes observed in the CR group. Compared with CR training, SRE-assisted walking training led to greater improvements in walking speed, endurance, and motor recovery. Our findings provide preliminary evidence that SRE may be considered for inclusion in intensive gait training clinical rehabilitation programs to further improve walking function in patients who have experienced stroke.

Cost-effectiveness of providing university students with a mindfulness-based intervention to reduce psychological distress: economic evaluation of a pragmatic randomised controlled trial

ObjectiveIncreasing numbers of young people attending university has raised concerns about the capacity of student mental health services to support them. We conducted a randomised controlled trial (RCT) to explore...

An Exposure-Based Cognitive–Behavioral Therapy for Youth with Severe Irritability: Feasibility and Preliminary Efficacy

ABSTRACT Objective Clinically impairing irritability and temper outbursts are among the most common psychiatric problems in youth and present transdiagnostically; however, few mechanistically informed treatments have been developed. Here, we test the acceptability, feasibility, and preliminary efficacy of a novel exposure-based treatment with integrated parent management skills for youth with severe irritability using a randomized between-subjects multiple baseline design. Method N = 41 patients (Age, Mean (SD) = 11.23 years (1.85), 62.5% male, 77.5% white) characterized by severe and impairing temper outbursts and irritability were randomized to different baseline observation durations (2, 4, or 6 weeks) prior to active treatment; 40 participants completed the 12 session treatment of exposure-based cognitive–behavioral therapy for irritability with integrated parent management skills. Masked clinician ratings were acquired throughout baseline and treatment phases, as well as 3- and 6-months post-treatment. To examine acceptability and feasibility, drop-out rates and adverse events were examined. Primary clinical outcome measures included clinician-administered measures of irritability severity and improvement. Secondary clinical outcome measures included multi-informant measures of irritability, depression, anxiety, and attention-deficit/hyperactivity disorder symptoms. Results No patients dropped out once treatment began, and no adverse events were reported. Irritability symptoms improved during the active phase of treatment across all measurements (all βs > –0.04, ps < .011, Cohen’s d range: –0.33 to –0.98). Treatment gains were maintained at follow-up (all βs (39) < –0.001, ps > .400). Sixty-five percent of patients were considered significantly improved or recovered post-treatment based on the primary clinician-rated outcome measure. Conclusions Results support acceptability, feasibility, and preliminary efficacy of this novel treatment for youth with severe irritability. Limitations and future directions are also discussed.

HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients with Cancer.

Psilocybin-assisted psychotherapy shows promise in treating depression and existential distress in people with serious medical illness. However, its individual-based methodology poses challenges for scaling and resource availability. The HOPE trial (A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients with Cancer) is an IRB-approved open-label feasibility and safety pilot study examining psilocybin-assisted group therapy in cancer patients with a DSM-5 depressive disorder (including major depressive disorder as well as adjustment disorder with depressed mood). We report here the safety and clinical outcome measures including 6-month follow up data. Outcome measures were collected at baseline, 2-week and 26-weeks post intervention. The study involved three group preparatory sessions, one high-dose (25mg) group psilocybin session, and three group integration sessions with cohorts of four participants over a three week intervention. 12 participants completed the trial. No serious adverse events attributed to psilocybin occurred. The primary clinical outcome measures of change in symptoms of depression on the clinician administered 17-item-HAM-D showed clinically substantial decrease in HAM-D scores from baseline to the 2-week timepoint (21.5 to 10.09, p<0.001) and the 26-week timepoint (21.5 to 14.83, p=0.006). Six out of twelve participants met criteria for remission at 2 weeks, as defined by HAM-D < 7, three out twelve demonstrated a clinically significant change (4-6 points), and eight out of twelve demonstrated a clinically substantial change (7-12 points). This pilot study demonstrated the safety, feasibility, and possible efficacy of psilocybin-assisted group therapy for cancer patients dealing with depressive symptoms. Based on demonstrated efficacy and significant reductions in therapist time, future investigations with the group therapy model are warranted. This article describes a single-arm, open-label pilot study of psilocybin-assisted group therapy for patients dealing with symptoms of depression associated with a cancer diagnosis. Results indicate that this intervention was safe and feasible with a suggestion of efficacy. Group-format psilocybin-assisted therapy is a promising methodology that addresses challenges of scalability.

The NuroSleeve, a user-centered 3D printed hybrid orthosis for individuals with upper extremity impairment

BackgroundActive upper extremity (UE) assistive devices have the potential to restore independent functional movement in individuals with UE impairment due to neuromuscular diseases or injury-induced chronic weakness. Academically fabricated UE assistive devices are not usually optimized for activities of daily living (ADLs), whereas commercially available alternatives tend to lack flexibility in control and activation methods. Both options are typically difficult to don and doff and may be uncomfortable for extensive daily use due to their lack of personalization. To overcome these limitations, we have designed, developed, and clinically evaluated the NuroSleeve, an innovative user-centered UE hybrid orthosis.MethodsThis study introduces the design, implementation, and clinical evaluation of the NuroSleeve, a user-centered hybrid device that incorporates a lightweight, easy to don and doff 3D-printed motorized UE orthosis and a functional electrical stimulation (FES) component. Our primary goals are to develop a customized hybrid device that individuals with UE neuromuscular impairment can use to perform ADLs and to evaluate the benefits of incorporating the device into occupational therapy sessions. The trial is designed as a prospective, open-label, single-cohort feasibility study of eight-week sessions combined with at-home use of the device and implements an iterative device design process where feedback from participants and therapists informs design improvement cycles.ResultsAll participants learned how to independently don, doff, and use the NuroSleeve in ADLs, both in clinical therapy and in their home environments. All participants showed improvements in their Canadian Occupational Performance Measure (COPM), which was the primary clinical trial outcome measure. Furthermore, participants and therapists provided valuable feedback to guide further development.ConclusionsOur results from non-clinical testing and clinical evaluation demonstrate that the NuroSleeve has met feasibility and safety goals and effectively improved independent voluntary function during ADLs. The study’s encouraging preliminary findings indicate that the NuroSleeve has met its technical and clinical objectives while improving upon the limitations of the existing UE orthoses owing to its personalized and flexible approach to hardware and firmware design.Trial Registration: ClinicalTrials.gov identifier: NCT04798378, https://clinicaltrials.gov/ct2/show/NCT04798378, date of registration: March 15, 2021.

Singapore KneE osTeoarthritis CoHort (SKETCH): protocol for a multi-centre prospective cohort study

BackgroundKnee osteoarthritis (OA) is a leading cause of global disability. The understanding of the role of psychosocial factors in knee OA outcomes is still evolving particularly in an Asian context. The primary aim of this study is to explore psychosocial factors that prognosticate short and long-term clinical outcomes, productivity, and healthcare utilization in patients with knee OA. Secondary aims are to explore the mediation and directional relationships and the role it plays in predicting the discordance between self-reported measures (SRM), physical-performance measures (PPMs) and objective clinical parameters.MethodsA multi-centre prospective cohort study of community ambulant knee OA patients seeking treatment in the tertiary healthcare institutions in Singapore will be conducted. Patients with secondary arthritis, significant cognitive impairment, severe medical comorbidities or previous knee arthroplasty will be excluded. Primary clinical outcome measure is the Knee injury and OA Outcome Score-12 (KOOS-12). Baseline characteristics include sociodemographic status, arthritis status including symptom duration and radiographic severity, comorbidities and functional status through Charlson Comorbidities Index (CCI), Barthel Index (BI) and Parker Mobility Score (PMS). Psychosocial variables include social support, kinesiophobia, negative affect, self-efficacy, injustice, chronic illness shame and the built environment. Clinical outcomes include quality of life, physical performance, global assessment, satisfaction and physical activity levels. Productivity and healthcare utilization will be assessed by a modified OA Cost and Consequences Questionnaire (OCC-Q) and the Work Productivity and Activity Impairment Questionnaire (WPAI). Variables will be collected at baseline, 4, 12 months and yearly thereafter. Regression, mediation and structural equation modelling will be used for analysis.DiscussionResults will allow contextualization, identification, and phenotyping of the critical (and potentially modifiable) psychosocial parameters that predict positive clinical outcomes in the OA population to guide optimization and refinement of healthcare and community. This will facilitate: 1. identification of high-risk knee OA subpopulations that will likely experience poor outcomes and 2. formulation of targeted multidisciplinary comprehensive approaches to address these psychosocial factors to optimize non-surgical treatment care, maximize functional outcomes and create more value-based care model for knee OA.Ethics and disseminationThe study has been registered under clinicaltrials.gov registry (Identifier: NCT04942236).

Protocol for a Pilot Randomized Controlled Mixed Methods Feasibility Trial of a Culturally Adapted Peer Support and Self-Management Intervention for African Americans

Due to diabetes disparities commonly seen among African Americans, it is important to address psychosocial and sociocultural barriers to medication adherence among African Americans with diabetes. Building on our prior work testing a culturally adapted peer supported diabetes self-management intervention for African Americans, this study will conduct a pilot randomized controlled feasibility trial that compares the culturally adapted intervention with a standard diabetes self-management program. Using an intervention mixed-methods design, the six-month trial will be conducted at two sites. Twenty-four African Americans with uncontrolled type 2 diabetes will be randomized to the intervention or control arm. Feasibility and acceptability outcomes in four domains (recruitment, intervention acceptability, intervention adherence, retention) will be collected. Primary clinical outcome (A1C), secondary outcome (medication adherence) and patient-specific psychosocial measures will be collected at baseline, 2 months, and 6 months. Document review, interview and focus groups will be used to gather qualitative data on feasibility and acceptability. Expected results are that the trial protocol will be feasible to implement and acceptable for participants, and there will be a signal of clinically meaningful reduction in A1C and improvements in medication adherence. The results of this trial will inform a future powered large-scale randomized controlled trial testing the effectiveness of the culturally tailored intervention.

Revised service metrics partially explain variation in outcomes across facilities in a state-wide advanced practice public musculoskeletal service.

Revised service metrics partially explain variation in outcomes across facilities in a state-wide advanced practice public musculoskeletal service.