The effect of the transfemoral prosthetic socket interface designs on skeletal motion and socket comfort: A randomized clinical trial

2020 ◽  
Vol 44 (3) ◽  
pp. 145-154 ◽  
Author(s):  
Jason Kahle ◽  
Rebecca Maria Miro ◽  
Loi T Ho ◽  
Michael Porter ◽  
Derek J Lura ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Repeated Measures ◽  
Weight Bearing ◽  
Standard Of Care ◽  
Vertical Movement ◽  
Full Weight Bearing ◽  
Controlled Clinical Trial ◽  
Current Standard ◽  
Prosthetic Socket ◽  
The Impact

Background: The most crucial aspect of a prosthesis is the socket, as it will directly determine gait stability and quality. The current standard of care ischial ramus containment socket is reported to increase coronal stability through gait; however, socket discomfort is the primary complaint among prosthetic users. Objectives: The purpose of this study is to compare ischial ramus containment to alternatives in the transfemoral amputee population. All subjects were fit with three different sockets: traditional ischial ramus containment, a dynamic socket, and a sub-ischial. In this study, authors hypothesized socket skeletal motion would be equivalent across interventions. Study Design: Single-blind, repeated-measures, three-period randomized crossover clinical trial. Methods: Outcome measures were socket comfort score and skeletal motion, viewed coronally with X-ray measuring the position of the skeleton in relationship to the socket in full weight-bearing and full un-loading. Results: The mean age was 38.2 and mean Amputee Mobility Predictor score was 40. Mean vertical movement, horizontal movement, single limb prosthetic stance, mean femoral adduction in swing and stance, and median socket comfort score were not statistically different. Conclusion: The socket design did not significantly effect skeletal motion and socket comfort. All socket designs are suitable depending on the patient-centric preferences and prosthetist skill set. Clinical relevance The comfort of the standard of care transfemoral amputation socket has been widely reported as problematic. A comparison of alternative designs in a controlled clinical trial environment will assist the clinician in understanding the impact of design regarding skeletal motion and comfort. Users could benefit from alternatives applied in clinical practice.

scholarly journals Predictive Monitoring: IMPact in Acute Care Cardiology Trial (PM-IMPACCT) - A Randomized Clinical Trial Protocol (Preprint)

2021 ◽  
Author(s):  
Jess Keim-Malpass ◽  
Sarah J Ratcliffe ◽  
Liza P Moorman ◽  
Matthew T Clark ◽  
Katy N Krahn ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Acute Care ◽  
Predictive Analytics ◽  
Healthcare Providers ◽  
Standard Of Care ◽  
Clinical Deterioration ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Icu Transfer ◽  
The Impact

BACKGROUND Patients on acute care wards who deteriorate and are emergently transferred to intensive care units have poor outcomes. Early identification of decompensating patients might allow for earlier clinical intervention and reduced morbidity and mortality. Advances in bedside continuous predictive analytics monitoring (i.e., artificial intelligence (AI)-based risk prediction) make complex data easily available to healthcare providers, and can provide early warning of potentially catastrophic clinical events. We present a dynamic, visual predictive analytics monitoring tool that integrates real-time bedside telemetric physiologic data into robust clinical models to estimate and communicate risk of imminent events. This tool, CoMET (Continuous Monitoring of Event Trajectories), has been shown in retrospective observational studies to predict clinical decompensation on the acute care ward. There is a need to more definitively study this advanced predictive analytics or AI monitoring system in a prospective, randomized controlled clinical trial. OBJECTIVE The goal of this trial is to determine the impact of an AI-based visual risk analytic, CoMET, on: (1) improving patient outcomes related to clinical deterioration, (2) response time to proactive clinical action, and (3) costs to the healthcare system. METHODS We propose a cluster randomized controlled trial (NCT04359641) to test the impact of displaying CoMET on an acute care cardiology and cardiothoracic surgery hospital floor. The number of admissions to a room undergoing cluster-randomization is estimated to be 10,424 over the 20-month study period. Cluster randomization based on bed number occurs every 2 months. The intervention cluster will have the CoMET score displayed (along with standard of care), while the usual care group receives standard of care only. RESULTS The primary outcome will be hours free from events of clinical deterioration. Hours of acute clinical events are defined as time when one or more of the following occur: emergent ICU transfer, emergent surgery prior to ICU transfer, cardiac arrest prior to ICU transfer, emergent intubation, or death. The clinical trial began randomization in January 2021. CONCLUSIONS Very few AI-based health analytics are translated from algorithm to real-world use. This study will use robust prospective, randomized controlled clinical trial methodology to assess the effectiveness of an advanced AI predictive analytics monitoring system incorporating real-time telemetric data for identifying clinical deterioration on acute care wards. This analysis will strengthen the ability of healthcare organizations to evolve as learning health systems, which apply bioinformatics data to improve patient outcomes by incorporating AI into knowledge tools that are successfully integrated into clinical practice by healthcare providers. CLINICALTRIAL Clinical trials identifier: NCT04359641

Association of pre-existing autoimmune diseases in melanoma patients receiving immune checkpoint inhibition with improved survival and increased toxicity.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21586-e21586
Author(s):  
Nicholas Gulati ◽  
Arda Celen ◽  
Paul Johannet ◽  
Amelia Sawyers ◽  
Min Jae Kim ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Autoimmune Disease ◽  
Autoimmune Diseases ◽  
Immune Checkpoint ◽  
Standard Of Care ◽  
Controlled Clinical Trial ◽  
Checkpoint Inhibition ◽  
Immune Checkpoint Inhibition ◽  
Before And After ◽  
The Impact

e21586 Background: Immune checkpoint inhibition (ICI) improves progression-free (PFS) and overall survival (OS) for patients with metastatic melanoma (MM), but induces immune-related adverse events (irAEs). Pre-existing autoimmune disease (pre-AI) is considered a relative contraindication due to concerns of inciting autoimmune flare. We here tested the impact of pre-AI on both the survival and irAEs in MM patients treated with ICI. Methods: We examined MM patients treated with ICI who were enrolled in a clinicopathological database at NYULH with protocol-driven prospective follow up. We compiled a comprehensive list of 23 autoimmune diseases and examined the presence of these diseases prior to ICI treatment. We tested the associations between pre-AI and PFS, OS, and irAEs both in univariate and multivariate models. Results: 74/485 (15.3%) patients, who received 718 lines of ICI treatment as either standard of care or in clinical trials, had pre-AI, most commonly asthma (n=42), inflammatory bowel disease (n=9), psoriasis (n=9), rheumatoid arthritis (n=7), and eczema (n=6). In patients receiving ICI as standard of care (n=535), pre-AI was associated with irAEs (P=0.05) as well as with significantly improved PFS (P=0.024) and OS (P=0.007), controlling for patients’ sex, age, stage, ECOG status, and treatment line (1st line versus 2nd or 3rd line). However, no associations were observed between pre-AI and PFS (P=0.2) or irAEs (P=0.54) in the clinical trial group. Conclusions: Our data demonstrate the disparate impact of pre-AI on response and irAEs in standard of care versus the highly controlled clinical trial settings, and underscore the importance of examining the complex interaction between autoimmune disease before and after initiation of ICI. Our data also challenge the notion that clinicians should avoid use of ICI in pre-AI patients. More mechanistic research is needed to understand how to uncouple ICI response from toxicity.

scholarly journals Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-Infected Infants with Severe Pneumonia: Study Protocol for a Multicenter, an Open-Label Randomized Controlled Clinical Trial

2021 ◽  
Author(s):  
Alfredo Tagarro ◽  
Cinta Moraleda ◽  
Sara Dominguez ◽  
Pui-Ying Iroh Tam ◽  
Christopher William Buck ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Severe Pneumonia ◽  
Standard Of Care ◽  
Empirical Treatment ◽  
Controlled Clinical Trial ◽  
African Countries ◽  
Clinical Trial Registry ◽  
Open Label ◽  
Secondary Endpoints ◽  
The Impact

Abstract Background Pneumonia is the primary cause of death among HIV-infected children in Africa, with mortality rates as high as 35-40% in infants hospitalized with severe pneumonia. Bacterial pathogens and Pneumocystis jirovecii are well known causes of pneumonia-related death, but other important causes such as cytomegalovirus (CMV) and tuberculosis (TB) remain under-recognized and under-treated.The immune response elicited by CMV may be associated with the risk of developing TB and TB disease progression, and CMV may accelerate disease caused both by HIV and TB. Minimally invasive autopsies confirm that CMV and TB are unrecognized causes of death in children wit HIV. CMV and TB may also co-infect the same child. The aim of this study is to compare the impact on 15-day and 1-year mortality of empirical treatment against TB and CMV plus standard of care (SoC) versus SoC in HIV-infected infants with severe pneumonia. Methods This is a Phase II-III, open-label randomized factorial (2x2) clinical trial, conducted in six African countries. The trial has four arms. Infants from 28 to 365 days of age HIV-infected and hospitalized with severe pneumonia will be randomized (1:1:1:1) to i) SoC, ii) valganciclovir iii) TB-T and iv) TB-T plus valganciclovir. The primary endpoint of the study is all-cause mortality, focusing on the short term (up to 15-days) and long-term (up to 1-year) mortality. Secondary endpoints include repeat hospitalization, duration of oxygen therapy during initial admission, severe and notable adverse events, adverse reactions, CMV and TB prevalence at enrolment, TB incidence, CMV viral load reduction, and evaluation of diagnostic tests such as GeneXpert Ultra on fecal and nasopharyngeal aspirate samples and urine TB-LAM.Discussion Given the challenges in diagnosing CMV and TB in children and results from previous autopsy studies that show high rates of poly-infection in HIV-infected infants with respiratory disease, , this study aims to evaluate a new approach including empirical treatment of CMV and TB for this patient population. The potential downsides of empirical treatment of these conditions including toxicity, and medication interactions, which will be evaluated with pharmacokinetics substudies. Trial Registration: ClinicalTrials.gov, NCT03915366, Universal Trial Number U111-1231-4736, Pan African Clinical Trial Registry PACTR201994797961340.

scholarly journals The impact of minimally invasive restorative techniques on perception of dental pain among pregnant women: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
May M. Adham ◽  
Mona K. El Kashlan ◽  
Wafaa E. Abdelaziz ◽  
Ahmed S. Rashad
Keyword(s):  
Clinical Trial ◽  
Dental Caries ◽  
Pregnant Women ◽  
Dental Pain ◽  
Controlled Clinical Trial ◽  
Atraumatic Restorative Treatment ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Caries Removal ◽  
The Impact

Abstract Background The public dental care sector is striving to fulfill the preventive and restorative needs of Egyptians, including pregnant women, who may not receive timely care due to misconceptions about dental treatment during pregnancy. Because of this, they are likely to suffer dental pain, with higher risk of infection affecting their offsprings. Aim of the study To compare the effectiveness of chemo-mechanical caries removal using Papacarie-Duo and Atraumatic Restorative Treatment (ART) in reducing dental pain among pregnant women. Materials and methods A randomized controlled clinical trial was conducted, in 2019, and included 162 pregnant women visiting family health centers in Alexandria, Egypt, with dental pain due to dental caries not extending to pulp. Patients were randomly assigned to Papacarie-Duo group (n = 82) and ART group (n = 80) after stratification by number of treated surfaces. The outcome variables were reduction in pain assessed using Visual Analogue Scale (VAS), satisfaction with treatment, and time taken for dental caries removal. T test/ Mann Whitney U test were used to compare groups and Freidman test was used to compare change across time. Results Pain reduction was significantly greater in the Papacarie-Duo than the ART group (81.55% and 69.43%, P = 0.001). Patients in the Papacarie-Duo group were significantly more satisfied with treatment than those in the ART, immediately after treatment (mean = 9.60 and 8.00, P =  < 0.01) and after 6 months (mean = 9.63 and 8.16, P =  < 0.01). Significantly less excavation time was recorded in the Papacarie-Duo group than in the ART group (mean = 10.38 and 11.56 min, P =  < 0.01). Conclusion Chemo-mechanical caries removal using Papacarie-Duo is more effective in reducing dental pain, in pregnant women, and is associated with more satisfaction and less excavation time than ART. Trial registration: ID NCT04573608 (https://clinicaltrials.gov/); 5/10/2020, retrospective registration.

scholarly journals The Impact of Parkinson’s Disease on Social Communication: An Exploratory Questionnaire Study

2021 ◽  
Author(s):  
Saryu Sharma ◽  
Kimberly Fleck ◽  
Sherri Winslow ◽  
Kathrin Rothermich
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Emotional Expression ◽  
Social Communication ◽  
Standard Of Care ◽  
Pragmatic Language ◽  
Current Standard ◽  
Comprehensive Management ◽  
Pragmatic Skills ◽  
The Impact

Individuals with Parkinson’s Disease (PD) often show breakdown in the interpretation of pragmatic language meaning. However, there is no current standard of care for evaluating social communication dysfunction in PD which affects the persons with PD and their caregivers. Thus, we developed a questionnaire for individuals with PD to evaluate social communication difficulties. Objective: The aim of this study was to develop a questionnaire to demonstrate a need for comprehensive management guidelines for individuals with PD regarding social communication skills. This questionnaire will highlight the areas of deficit for the individuals with PD. Methods: Fifty-one people with self-reported Parkinson’s Disease answered 28 survey questions. These questions pertained to emotional expression and perception, social communication, sarcasm/humor, and pragmatic skills. Exploratory factor analysis and reliability analysis were performed to identify which items loaded onto the desired factor and to check the internal consistency of the items. Results: Persons with PD reported changes in emotional expression and perception, social communication, sarcasm and humor, and pragmatic skills domains post PD diagnosis. No correlations were found between age/time since diagnosis and emotional expression, social communication, sarcasm, and humor.Conclusion: The current study provides evidence that persons with PD experience social communication challenges. Therefore, it is crucial to increase awareness of these deficits in PD to recognize the impact of the disease on social communication.

Impact of force magnitude on effectiveness in cervical headgear therapy: a cephalometric analysis

2019 ◽  
Vol 41 (6) ◽  
pp. 646-651 ◽  
Author(s):  
Tuula H Talvitie ◽  
Mika Helminen ◽  
Susanna Karsila ◽  
Reeta Varho ◽  
Luca Signorelli ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Clinical Trial ◽  
Cephalometric Analysis ◽  
Force Magnitude ◽  
Lateral Cephalograms ◽  
Significant Difference ◽  
The Impact

Summary Aim The main aim of this study was to study the impact of different force magnitudes on effectiveness in cervical headgear (CHG) therapy. Materials and methods Forty patients were treated with CHG with light (L; 300 g) or heavy (H; 500 g) force in this controlled clinical trial. Patients were asked to wear CHG for 10 hours/day for 10 months. The inner bow of the CHG was expanded (3–4 mm) and the long outer bow bent (10–20 degree) upward in relation to the inner bow. Adherence to instructions and force magnitude in CHG use was monitored by electronic module (Smartgear, Swissorthodontics, Switzerland). Lateral cephalograms were taken before (T1) and after (T2) the treatment and studied with modified Pancherz analysis using a Planmeca Romexis Ceph module (Planmeca, Finland). Results In both groups, skeletal and dental effects were seen. The only statistically significant difference in cephalometric analysis was the inclination of upper incisors at T1 (P = 0.010) and at T2 (P = 0.011). In both groups, a reduction in Sella-Nasion- point A (SNA) angle was found: L group T1 82.7degree (SD ± 3.6degree), T2 82.0degree (SD ± 3.5 degree) and H group T1 82.6 degree (SD ± 4.7 degree), T2 81.5 degree (SD ± 4.5 degree), but no statistically significant difference between the groups. Children in the L group used CHG statistically significantly more than those in the H group (10.0 ± 1.5 hour, and 8.3 ± 2.1 hour, respectively, P = 0.002). Conclusion Children with lower force CHG seem to adhere better to instructions for CHG use. After 10 months of use, no statistically significant differences were found in dental or skeletal outcome. However, in the H group, the outcome was achieved with less daily hours of use.

Effect of an early mobilisation programme on pain intensity after laparoscopic surgery: a randomised clinical trial

2020 ◽  
pp. bmjspcare-2020-002618
Author(s):  
Azam Dehghani ◽  
Ali Hajibagheri ◽  
Ismail Azizi-Fini ◽  
Fatemeh Atoof ◽  
Noushin Mousavi
Keyword(s):  
Clinical Trial ◽  
Laparoscopic Surgery ◽  
Pain Intensity ◽  
Repeated Measures ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Early Mobilisation ◽  
Repeated Measures Analysis ◽  
The Mean

BackgroundPain is a common complication after laparoscopic surgery. This study aimed to examine the effect of an early mobilisation programme on postoperative pain intensity after laparoscopic surgery.MethodsA randomised controlled clinical trial was conducted on 80 patients who underwent laparoscopic surgery in Shahid Beheshti Hospital in Kashan, Iran. The patients were randomly allocated to intervention (n=40) and a control (n=40) group. In the intervention group, an early mobilisation programme was implemented in two rounds. The patient’s perceived pain was assessed using a Visual Analogue Scale 15 min before and 30 min after each round of early mobilisation. Data were analysed through the independent samples t, χ2 and Fisher’s exact tests and the repeated measures analysis.ResultsThe repeated measures analysis showed that the mean pain scores have been decreased over time (F=98.88, p<0.001). Considering the observed interaction between time and the intervention, the t test was used for pairwise comparisons and showed that the mean pain score was not significantly different between the two groups in 15 min before the first round of early mobilisation (p=0.95). However, the mean pain in the intervention group was significantly less than the control group in all subsequent measurements (p<0.05).ConclusionEarly mobilisation programmes such as the one implemented in the current study are easy and inexpensive and can be implemented safely for the reduction of pain after laparoscopic surgeries.

scholarly journals Accuracy and consequences of usingtrial-of-antibioticsfor TB diagnosis (ACT-TB study): protocol for a randomised controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e033999
Author(s):  
Titus Henry Divala ◽  
Katherine L Fielding ◽  
Derek J Sloan ◽  
Neil French ◽  
Marriott Nliwasa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mycobacterium Tuberculosis ◽  
Research Ethics ◽  
Primary Outcome ◽  
Standard Of Care ◽  
Ethics Committee ◽  
Absolute Difference ◽  
Controlled Clinical Trial ◽  
London School ◽  
Randomised Controlled

IntroductionOver 40% of global tuberculosis case notifications are diagnosed clinically without mycobacteriological confirmation. Standard diagnostic algorithms include ‘trial-of-antibiotics’—empirical antibiotic treatment given to mycobacteriology-negative individuals to treat infectious causes of symptoms other than tuberculosis, as a ‘rule-out’ diagnostic test for tuberculosis. Potentially 26.5 million such antibiotic courses/year are prescribed globally for the 5.3 million/year mycobacteriology-negative patients, making trial-of-antibiotics the most common tuberculosis diagnostic, and a global-scale risk for antimicrobial resistance (AMR). Our systematic review found no randomised controlled trial (RCT) to support use of trial-of-antibiotic. The RCT aims to determine the diagnostic and clinical value and AMR consequences of trial-of-antibiotics.Methods and analysisA three-arm, open-label, RCT randomising (1:1:1) Malawian adults (≥18 years) seeking primary care for cough into: (a) azithromycin 500 mg one time per day for 3 days or (b) amoxicillin 1 g three times per day for 5 days or (c) standard-of-care (no immediate antibiotic). We will perform mycobacteriology tests (microscopy, Xpert MTB/RIF (Mycobacterium tuberculosis/rifampicin) andMycobacterium tuberculosisculture) at baseline. We will use audiocomputer-assisted self-interview to assess clinical improvement at day 8. First primary outcome will be proportion of patients reporting day 8 improvement out of those with negative mycobacteriology (specificity). Second primary outcome will be day 29 incidence of a composite endpoint of either death or hospitalisation or missed tuberculosis diagnosis. To determine AMR impact we compare proportion of resistant nasopharyngealStreptococcus pneumoniaeisolates on day 29. 400 mycobacteriology-negative participants/arm will be required to detect a ≥10% absolute difference in diagnostic specificity with 80% power. We will estimate measures of effect by comparing outcomes in antibiotic arms (combined and individually) to standard-of-care.Ethics and disseminationThe study has been reviewed and approved by Malawi College of Medicine Research and Ethics Committee, London School of Hygiene & Tropical Medicine (LSHTM) Research Ethics Committee and Regional Committee for Health and Research Ethics – Norway, and Malawi Pharmacy, Medicines and Poisons Board. We will present abstracts at relevant conferences, and prepare a manuscript for publication in a peer-reviewed journal.Trial registration numberThe clinical trial is registered with ClinicalTrials.gov,NCT03545373

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