-
Medicine Jun 2024Upper limb dysfunction is one of the most common sequelae of stroke and robotic therapy is considered one of the promising methods for upper limb rehabilitation. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Upper limb dysfunction is one of the most common sequelae of stroke and robotic therapy is considered one of the promising methods for upper limb rehabilitation.
OBJECTIVE
This study aimed to explore the clinical effectiveness of upper limb training using a rehabilitation robotic device (Rebless®) for patients with stroke.
METHODS
In this prospective, unblinded, randomized controlled trial, patients were randomly assigned to receive robotic training (experimental group, n = 15) or conventional therapy (control group, n = 15). Both groups received upper limb training lasting for 30 minutes per session with a total of 10 training sessions within 4 weeks. Motor function, functional evaluation, and spasticity were clinically assessed before and after the training. Cortical activation was measured using functional near-infrared spectroscopy at the 1st and 10th training sessions.
RESULTS
The experimental group demonstrated a significant improvement in the Fugl-Meyer assessment-upper extremity score and the modified Ashworth scale grade in elbow flexors. The cortical activity of the unaffected hemisphere significantly decreased after 10 training sessions in the experimental group compared with the control group.
CONCLUSIONS
The experimental group showed significant improvement in the Fugl-Meyer assessment-upper extremity score and spasticity of elbow flexors and had significantly decreased cortical activity of the unaffected hemisphere. Training with Rebless® may help patients with chronic stroke in restoring upper limb function and recovering the contralateral predominance of activation in motor function.
Topics: Humans; Stroke Rehabilitation; Male; Female; Upper Extremity; Middle Aged; Prospective Studies; Robotics; Aged; Stroke; Recovery of Function; Muscle Spasticity; Treatment Outcome; Chronic Disease; Exercise Therapy
PubMed: 38941364
DOI: 10.1097/MD.0000000000038753 -
PloS One 2024This study began as a single-blind randomized controlled trial (RCT) to investigate the efficacy and safety of electroconvulsive therapy (ECT) for severe... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
This study began as a single-blind randomized controlled trial (RCT) to investigate the efficacy and safety of electroconvulsive therapy (ECT) for severe treatment-refractory agitation in advanced dementia. The aims are to assess agitation reduction using the Cohen-Mansfield Agitation Inventory (CMAI), evaluate tolerability and safety outcomes, and explore the long-term stability of agitation reduction and global functioning. Due to challenges encountered during implementation, including recruitment obstacles and operational difficulties, the study design was modified to an open-label format and other protocol amendments were implemented.
METHODS
Initially, the RCT randomized participants 1:1 to either ECT plus usual care or simulated ECT plus usual care (S-ECT) groups. As patients were enrolled, data were collected from both ECT and simulated ECT (S-ECT) patients. The study now continues in an open-label study design where all patients receive actual ECT, reducing the targeted sample size from 200 to 50 participants.
RESULTS
Study is ongoing and open to enrollment.
CONCLUSION
The transition of the ECT-AD study design from an RCT to open-label design exemplifies adaptive research methodologies in response to real-world challenges. Data from both the RCT and open-label phases of the study will provide a unique perspective on the role of ECT in managing severe treatment-refractory agitation in dementia, potentially influencing future clinical practices and research approaches.
Topics: Humans; Electroconvulsive Therapy; Psychomotor Agitation; Dementia; Single-Blind Method; Female; Male; Treatment Outcome; Aged; Aberrant Motor Behavior in Dementia
PubMed: 38941338
DOI: 10.1371/journal.pone.0303894 -
PloS One 2024The global rise in diabetes, particularly in India, poses a significant public health challenge, with factors such as limited awareness, financial strain, and cultural...
BACKGROUND
The global rise in diabetes, particularly in India, poses a significant public health challenge, with factors such as limited awareness, financial strain, and cultural considerations hindering its effective management. Although lifestyle changes have shown promising results, their consistent implementation and maintenance continue to pose challenges. Most studies have focused primarily on dietary modifications, overlooking other essential aspects of lifestyle intervention. The DiRemI study aims to address these gaps by evaluating the efficacy of a comprehensive one-year program that combines diet, exercise, psychological support, and medical management to achieve weight loss, diabetes remission, and improved glycemic control among patients with type 2 diabetes (T2D) in India, while also considering the unique needs of the Indian population.
METHODS
The DiRemI study is a prospective, open-label, matched-group trial aimed at assessing the impact of a one-year online integrated intensive lifestyle intervention (ILI) comprising dietary modifications, physical activity, psychological support, and medical management on weight loss and remission in adult T2D patients (aged 30-70 years), with a body mass index (BMI) between 25 and 35 kg/m2, and disease duration of <15 years. ILI will be compared with routine medical care (RMC). Participants will be recruited from three clinics: one providing ILI and two others providing RMC. The co-primary outcome will be weight loss and remission at 12 months, with a follow-up at 18 months. The proposed sample size is 360 participants (180 each in intervention and control group).
DISCUSSION
The DiRemI study represents the first large-scale remission study in India to show the effectiveness of an integrated approach in the remission and management of T2D and its complications. The findings of this study hold the potential to report evidence-based strategies for managing T2D both in India and globally, thus alleviating the substantial burden of diabetes on public health systems.
TRIAL REGISTRATION
Clinical Trials Registry, India (Registered Number: CTRI/2023/06/053885).
Topics: Humans; Diabetes Mellitus, Type 2; India; Prospective Studies; Middle Aged; Adult; Female; Male; Aged; Weight Loss; Exercise; Life Style; Remission Induction; Body Mass Index
PubMed: 38941311
DOI: 10.1371/journal.pone.0306394 -
JMIR Research Protocols Jun 2024Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have...
BACKGROUND
Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have shown potential for a range of clinical tasks such as diagnostics, prognostics, and therapeutic decision-making such as drug dosing. There is, however, an urgent need to ensure that these technologies remain safe for all populations. Recent literature demonstrates the need for rigorous performance error analysis to identify issues such as algorithmic encoding of spurious correlations (eg, protected characteristics) or specific failure modes that may lead to patient harm. Guidelines for reporting on studies that evaluate AI medical devices require the mention of performance error analysis; however, there is still a lack of understanding around how performance errors should be analyzed in clinical studies, and what harms authors should aim to detect and report.
OBJECTIVE
This systematic review will assess the frequency and severity of AI errors and adverse events (AEs) in randomized controlled trials (RCTs) investigating AI medical devices as interventions in clinical settings. The review will also explore how performance errors are analyzed including whether the analysis includes the investigation of subgroup-level outcomes.
METHODS
This systematic review will identify and select RCTs assessing AI medical devices. Search strategies will be deployed in MEDLINE (Ovid), Embase (Ovid), Cochrane CENTRAL, and clinical trial registries to identify relevant papers. RCTs identified in bibliographic databases will be cross-referenced with clinical trial registries. The primary outcomes of interest are the frequency and severity of AI errors, patient harms, and reported AEs. Quality assessment of RCTs will be based on version 2 of the Cochrane risk-of-bias tool (RoB2). Data analysis will include a comparison of error rates and patient harms between study arms, and a meta-analysis of the rates of patient harm in control versus intervention arms will be conducted if appropriate.
RESULTS
The project was registered on PROSPERO in February 2023. Preliminary searches have been completed and the search strategy has been designed in consultation with an information specialist and methodologist. Title and abstract screening started in September 2023. Full-text screening is ongoing and data collection and analysis began in April 2024.
CONCLUSIONS
Evaluations of AI medical devices have shown promising results; however, reporting of studies has been variable. Detection, analysis, and reporting of performance errors and patient harms is vital to robustly assess the safety of AI medical devices in RCTs. Scoping searches have illustrated that the reporting of harms is variable, often with no mention of AEs. The findings of this systematic review will identify the frequency and severity of AI performance errors and patient harms and generate insights into how errors should be analyzed to account for both overall and subgroup performance.
TRIAL REGISTRATION
PROSPERO CRD42023387747; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=387747.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
PRR1-10.2196/51614.
Topics: Humans; Randomized Controlled Trials as Topic; Artificial Intelligence; Algorithms; Systematic Reviews as Topic; Patient Harm; Equipment and Supplies; Research Design
PubMed: 38941147
DOI: 10.2196/51614 -
JMIR Research Protocols Jun 2024Pulmonary rehabilitation is widely recommended to improve functional status and as secondary and tertiary prevention in individuals with chronic pulmonary diseases....
Assessing Functional Capacity in Directly and Remotely Monitored Home-Based Settings in Individuals With Chronic Respiratory Diseases: Protocol for a Multinational Validation Study.
BACKGROUND
Pulmonary rehabilitation is widely recommended to improve functional status and as secondary and tertiary prevention in individuals with chronic pulmonary diseases. Unfortunately, access to timely and appropriate rehabilitation remains limited. To help close this inaccessibility gap, telerehabilitation has been proposed. However, exercise testing is necessary for effective and safe exercise prescription. Current gold-standard tests, such as maximal cardiopulmonary exercise testing (CPET) and the 6-minute walk test (6MWT), are poorly adapted to home-based or telerehabilitation settings. This was an obstacle to the continuity of services during the COVID-19 pandemic. It is essential to validate tests adapted to these new realities, such as the 6-minute stepper test (6MST). This test, strongly inspired by 6MWT, consists of taking as many steps as possible on a "stepper" for 6 minutes.
OBJECTIVE
This study aims to evaluate the metrological qualities of 6MST by (1) establishing concurrent validity and agreement between the 6MST and CPET, as well as with the 6MWT; (2) determining test-retest reliability in a home-based setting with direct and remote (videoconferencing) monitoring; and (3) documenting adverse events and participant perspectives when performing the 6MST in home-based settings.
METHODS
Three centers (Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec in Québec, Groupement des Hôpitaux de l'Institut Catholique de Lille in France, and FormAction Santé in France) will be involved in this multinational project, which is divided into 2 studies. For study 1 (objective 1), 30 participants (Québec, n=15; France, n=15) will be recruited. Two laboratory visits will be performed to assess anthropometric data, pulmonary function, and the 3 exercise tolerance tests (CPET, 6MWT, and 6MST). Concurrent validity (paired sample t tests and Pearson correlations) and agreement (Bland-Altman plots with 95% agreement limits) will be evaluated. For study 2 (objectives 2 and 3), 52 participants (Québec, n=26; France, n=26) will be recruited. Following a familiarization trial (trial 1), the 6MST will be conducted on 2 separate occasions (trials 2 and 3), once under direct supervision and once under remote supervision, in a randomized order. Paired sample t test, Bland-Altman plots, and intraclass correlations will be used to compare trials 2 and 3. A semistructured interview will be conducted after the third trial to collect participants' perspectives.
RESULTS
Ethical approval was received for this project (October 12, 2023, in Québec and September 25, 2023, in France) and the first participant was recruited in February 2024.
CONCLUSIONS
This study innovates by validating a new clinical test necessary for the development and implementation of new models of rehabilitation adapted to home and telerehabilitation contexts. This study also aligns with the United Nations Sustainable Development Goals by contributing to augmenting health care service delivery (goal 3) and reducing health care access inequalities (goal 11).
TRIAL REGISTRATION
ClinicalTrials.gov NCT06447831; https://clinicaltrials.gov/study/NCT06447831.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/57404.
Topics: Humans; Chronic Disease; Exercise Test; Reproducibility of Results; COVID-19; Male; Female; Adult; Middle Aged; Telerehabilitation; Walk Test; Telemedicine
PubMed: 38941132
DOI: 10.2196/57404 -
JAMA Network Open Jun 2024The efficacy of a semirecumbent position (SRP) in reducing postoperative hypoxemia during anesthesia emergence is unclear despite its widespread use. (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
The efficacy of a semirecumbent position (SRP) in reducing postoperative hypoxemia during anesthesia emergence is unclear despite its widespread use.
OBJECTIVE
To determine the differences in postoperative hypoxemia between patients in an SRP and a supine position.
DESIGN, SETTING, AND PARTICIPANTS
This randomized clinical trial was performed at a tertiary hospital in China between March 20, 2021, and May 10, 2022. Patients scheduled to undergo laparoscopic upper abdominal surgery under general anesthesia were enrolled. Study recruitment and follow-up are complete.
INTERVENTIONS
Patients were randomized to 1 of the following positions at the end of the operation until leaving the postanesthesia care unit: supine (group S), 15° SRP (group F), or 30° SRP (group T).
MAIN OUTCOMES AND MEASURES
The primary outcome was the incidence of postoperative hypoxemia in the postanesthesia care unit. Severe hypoxemia was also evaluated.
RESULTS
Out of 700 patients (364 men [52.0%]; mean [SD] age, 47.8 [11.3] years), 233 were randomized to group S (126 men [54.1%]; mean [SD] age, 48.2 [10.9] years), 233 to group F (122 men [52.4%]; mean [SD] age, 48.1 [10.9] years), and 234 to group T (118 women [50.4%]; mean [SD] age, 47.2 [12.1] years). Postoperative hypoxemia differed significantly among the 3 groups (group S, 109 of 233 [46.8%]; group F, 105 of 233 [45.1%]; group T, 76 of 234 [32.5%]; P = .002). This difference was statistically significant for groups T vs S (risk ratio [RR], 0.69 [95% CI, 0.55-0.87]; P = .002) and groups T vs F (RR, 0.72 [95% CI, 0.57-0.91]; P = .007), but not for groups F vs S (RR, 0.96 [95% CI, 0.79-1.17]; P = .78). Severe hypoxemia also differed among the 3 groups (group S, 61 of 233 [26.2%]; group F, 53 of 233 [22.7%]; group T, 36 of 234 [15.4%]; P = .01). This difference was statistically significant for groups T vs S (RR, 0.59 [95% CI, 0.41-0.85]; P = .005).
CONCLUSIONS AND RELEVANCE
In this randomized clinical trial of SRP during anesthesia recovery in patients undergoing laparoscopic upper abdominal surgery, postoperative hypoxemia was significantly reduced in group T compared with group F or group S.
TRIAL REGISTRATION
Chinese Clinical Trial Registry Identifier: ChiCTR2100045087.
Topics: Humans; Male; Female; Middle Aged; Hypoxia; Postoperative Complications; Patient Positioning; Adult; Anesthesia Recovery Period; Anesthesia, General; China; Laparoscopy; Supine Position; Abdomen
PubMed: 38941098
DOI: 10.1001/jamanetworkopen.2024.16797 -
Translational Vision Science &... Jun 2024To compare changes in superficial retinal vascular density (SRVD), deep retinal vascular density (DRVD), and retinal thickness (RT) of the macular zone after repeated... (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
PURPOSE
To compare changes in superficial retinal vascular density (SRVD), deep retinal vascular density (DRVD), and retinal thickness (RT) of the macular zone after repeated low-level red light (RLRL) and 0.01% atropine exposure in premyopic schoolchildren.
METHODS
Prospective randomized trial. Sixty-nine schoolchildren with cycloplegic refraction >-0.75 D and ≤0.50 D were randomly assigned to RLRL and 0.01% atropine groups. SRVD, DRVD, and RT were measured using swept-source optical coherence tomography at baseline and six months. The macular zone was divided into three concentric rings (fovea, parafovea, and perifovea) using the Early Treatment Diabetic Retinopathy Study.
RESULTS
After six months, the whole, parafoveal, and perifoveal SRVD significantly increased in the two groups (all P < 0.05). Multivariate regression analyses showed that none of these changes varied significantly between the two groups (all P > 0.05), whereas foveal SRVD remained stable in both groups (all P > 0.05). In the RLRL group, the whole and perifoveal DRVD increased significantly (all P < 0.05), whereas no statistical difference was observed in the foveal and parafoveal DRVD. DRVD remained stable in the 0.01% atropine group (all P > 0.05). No significant differences were observed in RT changes between the two groups (all P > 0.05). In comparison, there were no significant changes in SRVD, DRVD, or RT after six months in the placebo group in our previous study.
CONCLUSIONS
SRVD increased similarly in the RLRL and 0.01% atropine groups, whereas DRVD increased only in the former group. There were no significant RT changes in either group after six months of treatment in premyopic schoolchildren.
TRANSLATIONAL RELEVANCE
This research observed the effects of low-level red light and 0.01% atropine on retinal vasculature, offering valuable insights into myopia progression prevention.
Topics: Humans; Atropine; Male; Female; Child; Prospective Studies; Retinal Vessels; Mydriatics; Tomography, Optical Coherence; Myopia; Ophthalmic Solutions; Phototherapy; Microvascular Density; Red Light
PubMed: 38940757
DOI: 10.1167/tvst.13.6.23 -
Cancer Medicine Jul 2024The Cancer Health Awareness through screeNinG and Education (CHANGE) initiative delivers cancer awareness education with an emphasis on modifiable risk factors and...
BACKGROUND
The Cancer Health Awareness through screeNinG and Education (CHANGE) initiative delivers cancer awareness education with an emphasis on modifiable risk factors and navigation to screening for prostate, breast, and colorectal cancers to residents of public housing communities who experience significant negative social determinants of health.
METHODS
Residents of five communities participated. Community advisory board members were recruited and provided feedback to local environmental change projects, recruitment, and community engagement at each site. At each site, four education sessions were provided by trained facilitators on cancer risk factors and etiology, racial disparities, eligibility for cancer screening, and participation in clinical trials. Attendance, knowledge, attitudes and beliefs about cancer, and height, weight, and waist circumference were measured at baseline and 1-week post-CHANGE sessions.
RESULTS
90 residents (60% 65 and older years old, 33% male, 60% High School education, 93% AA) participated in the program. 95% completed post-intervention evaluation. Participants were eligible for breast (n = 12), prostate (n = 15), and colorectal screening (n = 25) based on American Cancer Society guidelines, and 22 for tobacco cessation; 21 participants accepted navigation assistance for these services. At post-test, participants significantly increased in knowledge and behaviors around obesity/overweight risk for cancer, nutrition, and physical activity. Colorectal, prostate, and breast cancer knowledge scores also increased, but were not significant.
CONCLUSIONS
CHANGE participants demonstrated improved health knowledge and intentions to improve their modifiable health behaviors. Participants reported being motivated and confident in seeking preventive care and satisfaction with community engagement efforts. Replication of this project in similar communities may improve knowledge and health equity among underserved populations.
Topics: Humans; Male; Female; Early Detection of Cancer; Aged; Health Knowledge, Attitudes, Practice; Middle Aged; Health Equity; Prostatic Neoplasms; Health Education; Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Adult; Risk Factors
PubMed: 38940418
DOI: 10.1002/cam4.7357 -
Clinical Cardiology Jul 2024Chronic heart failure (CHF) has always posed a significant threat to human survival and health. The efficacy of thiamine supplementation in CHF patients remains... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Chronic heart failure (CHF) has always posed a significant threat to human survival and health. The efficacy of thiamine supplementation in CHF patients remains uncertain.
HYPOTHESIS
Receiving supplementary thiamine may not confer benefits to patients with CHF.
METHODS
A comprehensive search was conducted across the Cochrane Library, PubMed, EMBASE, ClinicalTrials.gov, and Web of Science databases up until May 2023 to identify articles investigating the effects of thiamine supplementation in CHF patients. Predefined criteria were utilized for selecting data on study characteristics and results.
RESULTS
Seven randomized, double-blind, controlled trials (five parallel trials and two crossover trials) involving a total of 274 patients were enrolled. The results of the meta-analysis pooling these studies did not reveal any significant effect of thiamine treatment compared with placebo on left ventricular ejection fraction (WMD = 1.653%, 95% CI: -1.098 to 4.405, p = 0.239, I = 61.8%), left ventricular end-diastolic volume (WMD = -6.831 mL, 95% CI: -26.367 to 12.704, p = 0.493, I = 0.0%), 6-min walking test (WMD = 16.526 m, 95% CI: -36.582 to 69.634, p = 0.542, I = 66.3%), N-terminal pro-B type natriuretic peptide (WMD = 258.150 pg/mL, 95% CI: -236.406 to 752.707, p = 0.306, I = 21.6%), or New York Heart Association class (WMD = -0.223, 95% CI: -0.781 to 0.335, p = 0.434, I = 87.1%). However, it effectively improved the status of thiamine deficiency (TD).
CONCLUSIONS
Our meta-analysis indicates that thiamine supplementation does not have a direct therapeutic effect on CHF, except for correcting TD.
Topics: Humans; Heart Failure; Thiamine; Randomized Controlled Trials as Topic; Dietary Supplements; Chronic Disease; Ventricular Function, Left; Stroke Volume; Vitamin B Complex; Treatment Outcome
PubMed: 38940395
DOI: 10.1002/clc.24309 -
Polski Przeglad Chirurgiczny Feb 2024<br><b>Introduction:</b> Roux-en-Y gastric bypass (RYGB) is a leading bariatric surgery globally. One-anastomosis gastric bypass (OAGB), a modification... (Comparative Study)
Comparative Study
<br><b>Introduction:</b> Roux-en-Y gastric bypass (RYGB) is a leading bariatric surgery globally. One-anastomosis gastric bypass (OAGB), a modification of RYGB, ranks as the third most common bariatric procedure in Poland. While clinical trials show that OAGB outcomes are comparable to those of RYGB regarding weight loss, remission of comorbidities, and hormonal impact, there is limited data on long-term outcomes and complications.</br><br><b>Aim:</b> The aim of the study was to compare the outcomes of revisional surgeries conducted after OAGB <i>versus</i> RYGB.</br> <br><b>Material and methods:</b> This retrospective study analyzed patients undergoing revisional bariatric surgeries from January 2010 to January 2020 across 12 Polish centers. The inclusion criteria were an age of at least 18 years and prior OAGB or RYGB surgery. Those with incomplete primary surgery data and follow-up post-revision were excluded. Data were collected regarding parameters for anthropometrics, comorbidities, and perioperative details. The patients were categorized based on their initial surgery: OAGB or RYGB. The primary endpoints were the reasons for and types of revisional surgery and weight changes; the secondary endpoints were postoperative complications and length of hospital stay (LOS).</br> <br><b>Results:</b> In total, 27 patients participated, with a mean age of 38.18 7 years. Differences between the OAGB (13 patients) and RYGB (14 patients) groups included median initial body weight (100 kg <i>vs.</i> 126 kg, p<0.016), number of postoperative complications (9 <i>vs.</i> 3, p = 0.021), and median LOS (3 <i>vs.</i> 4.5 days, p = 0.03). GERD was the primary reason for OAGB revisions (69.2%), whereas insufficient weight loss led to the most RYGB revisions (42.9%).</br><br><b>Conclusions:</b> The RYGB patients commonly needed revisions due to weight issues, whereas reoperations in the OAGB patients were conducted due to postoperative complications. The postoperative complications and LOS were similar between the groups.</br> <br><b>The importance of research for the development of the field:</b> The results may influence clinical surgeons' choice of surgical technique.</br>.
Topics: Humans; Poland; Reoperation; Female; Male; Adult; Gastric Bypass; Retrospective Studies; Middle Aged; Postoperative Complications; Obesity, Morbid; Treatment Outcome; Weight Loss
PubMed: 38940250
DOI: 10.5604/01.3001.0054.2678