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Scientific Reports May 2023Gait biofeedback is a well-studied strategy to reduce gait impairments such as propulsion deficits or asymmetric step lengths. With biofeedback, participants alter their...
Gait biofeedback is a well-studied strategy to reduce gait impairments such as propulsion deficits or asymmetric step lengths. With biofeedback, participants alter their walking to reach the desired magnitude of a specific parameter (the biofeedback target) with each step. Biofeedback of anterior ground reaction force and step length is commonly used in post-stroke gait training as these variables are associated with self-selected gait speed, fall risk, and the energy cost of walking. However, biofeedback targets are often set as a function of an individual's baseline walking pattern, which may not reflect the ideal magnitude of that gait parameter. Here we developed prediction models based on speed, leg length, mass, sex, and age to predict anterior ground reaction force and step length of neurotypical adults as a possible method for personalized biofeedback. Prediction of these values on an independent dataset demonstrated strong agreement with actual values, indicating that neurotypical anterior ground reaction forces can be estimated from an individual's leg length, mass, and gait speed, and step lengths can be estimated from individual's leg length, mass, age, sex, and gait speed. Unlike approaches that rely on an individual's baseline gait, this approach provides a standardized method to personalize gait biofeedback targets based on the walking patterns exhibited by neurotypical individuals with similar characteristics walking at similar speeds without the risk of over- or underestimating the ideal values that could limit feedback-mediated reductions in gait impairments.
Topics: Humans; Adult; Walking Speed; Gait; Walking; Stroke; Biofeedback, Psychology; Biomechanical Phenomena
PubMed: 37202435
DOI: 10.1038/s41598-023-35317-y -
JAMA Pediatrics Jul 2023The risk of serious long-term outcomes for infants born to individuals with opioid use disorder (OUD) is not fully characterized, nor is it well understood whether risks...
IMPORTANCE
The risk of serious long-term outcomes for infants born to individuals with opioid use disorder (OUD) is not fully characterized, nor is it well understood whether risks are modified by infant diagnosis of neonatal opioid withdrawal syndrome (NOWS).
OBJECTIVE
To characterize the risk of postneonatal infant mortality among infants with a NOWS diagnosis or born to individuals with OUD.
DESIGN, SETTING, AND PARTICIPANTS
The study team conducted a retrospective cohort study of 390 075 infants born from 2007 through 2018 to mothers who were enrolled in Tennessee Medicaid from 183 days prior to delivery through 28 days post partum (baseline). Maternal and infant baseline characteristics were measured using administrative claims and birth certificates, and infants were followed up from day 29 post partum through day 365 or death. Deaths were identified using linked death certificates through 2019. These data were analyzed from February 10, 2022, through March 3, 2023.
EXPOSURE
Infant exposures included birth to an individual with OUD or postnatal diagnosis of NOWS. The study team defined a pregnant individual's OUD status (maternal OUD) as having OUD diagnosis or a maintenance medication prescription fill during baseline; this study defined NOWS as having NOWS diagnosis up to day 28. Groups were categorized by exposures as maternal OUD with NOWS (OUD positive/NOWS positive), maternal OUD without NOWS (OUD positive/NOWS negative), no documented maternal OUD with NOWS (OUD negative/NOWS positive), and no documented maternal OUD or NOWS (OUD negative/NOWS negative, unexposed).
MAIN OUTCOME AND MEASURES
The outcome was postneonatal infant death, confirmed by death certificates. Cox proportional hazards models were used, adjusting for baseline maternal and infant characteristics, to estimate adjusted hazard ratios (aHRs) and 95% CIs for the association between maternal OUD or NOWS diagnosis with postneonatal death.
RESULTS
Pregnant individuals in the cohort had a mean (SD) age of 24.5 (5.2) years; 51% of infants were male. The study team observed 1317 postneonatal infant deaths and incidence rates of 3.47 (OUD negative/NOWS negative, 375 718), 8.41 (OUD positive/NOWS positive, 4922); 8.95 (OUD positive/NOWS negative, 7196), and 9.25 (OUD negative/NOWS positive, 2239) per 1000 person-years. After adjustment, the risk of postneonatal death was elevated for all groups, relative to the unexposed: OUD positive/NOWS positive (aHR, 1.54; 95% CI, 1.07-2.21), OUD positive/NOWS negative (aHR, 1.62; 95% CI, 1.21-2.17), and OUD negative/NOWS positive (aHR, 1.64; 95% CI, 1.02-2.65).
CONCLUSIONS AND RELEVANCE
Infants born to individuals with OUD or with a NOWS diagnosis had an increased risk of postneonatal infant mortality. Future work is necessary to create and evaluate supportive interventions for individuals with OUD during and after pregnancy to reduce adverse outcomes.
Topics: Infant; Infant, Newborn; Pregnancy; Female; Male; Humans; Young Adult; Adult; Retrospective Studies; Infant Mortality; Opioid-Related Disorders; Mothers; Neonatal Abstinence Syndrome; Analgesics, Opioid
PubMed: 37155175
DOI: 10.1001/jamapediatrics.2023.1047 -
Trials May 2023Postoperative morbidity and mortality in patients undergoing major emergency gastrointestinal surgery are a major burden on healthcare systems. Optimal management of...
Fluid Optimisation in Emergency Laparotomy (FLO-ELA) Trial: study protocol for a multi-centre randomised trial of cardiac output-guided fluid therapy compared to usual care in patients undergoing major emergency gastrointestinal surgery.
INTRODUCTION
Postoperative morbidity and mortality in patients undergoing major emergency gastrointestinal surgery are a major burden on healthcare systems. Optimal management of perioperative intravenous fluids may reduce mortality rates and improve outcomes from surgery. Previous small trials of cardiac-output guided haemodynamic therapy algorithms in patients undergoing gastrointestinal surgery have suggested this intervention results in reduced complications and a modest reduction in mortality. However, this existing evidence is based mainly on elective (planned) surgery, with little evaluation in the emergency setting. There are fundamental clinical and pathophysiological differences between the planned and emergency surgical setting which may influence the effects of this intervention. A large definitive trial in emergency surgery is needed to confirm or refute the potential benefits observed in elective surgery and to inform widespread clinical practice.
METHODS
The FLO-ELA trial is a multi-centre, parallel-group, open, randomised controlled trial. 3138 patients aged 50 and over undergoing major emergency gastrointestinal surgery will be randomly allocated in a 1:1 ratio using minimisation to minimally invasive cardiac output monitoring to guide protocolised administration of intra-venous fluid, or usual care without cardiac output monitoring. The trial intervention will be carried out during surgery and for up to 6 h postoperatively. The trial is funded through an efficient design call by the National Institute for Health and Care Research Health Technology Assessment (NIHR HTA) programme and uses existing routinely collected datasets for the majority of data collection. The primary outcome is the number of days alive and out of hospital within 90 days of randomisation. Participants and those delivering the intervention will not be blinded to treatment allocation. Participant recruitment started in September 2017 with a 1-year internal pilot phase and is ongoing at the time of publication.
DISCUSSION
This will be the largest contemporary randomised trial examining the effectiveness of perioperative cardiac output-guided haemodynamic therapy in patients undergoing major emergency gastrointestinal surgery. The multi-centre design and broad inclusion criteria support the external validity of the trial. Although the clinical teams delivering the trial interventions will not be blinded, significant trial outcome measures are objective and not subject to detection bias.
TRIAL REGISTRATION
ISRCTN 14729158. Registered on 02 May 2017.
Topics: Aged; Humans; Middle Aged; Cardiac Output; Digestive System Surgical Procedures; Fluid Therapy; Hemodynamics; Laparotomy; Multicenter Studies as Topic; Randomized Controlled Trials as Topic
PubMed: 37149623
DOI: 10.1186/s13063-023-07275-3 -
Scientific Reports May 2023The paper deals with the evaluation of the performance of an existing and previously validated CT based radiomic signature, developed in oropharyngeal cancer to predict...
The paper deals with the evaluation of the performance of an existing and previously validated CT based radiomic signature, developed in oropharyngeal cancer to predict human papillomavirus (HPV) status, in the context of anal cancer. For the validation in anal cancer, a dataset of 59 patients coming from two different centers was collected. The primary endpoint was HPV status according to p16 immunohistochemistry. Predefined statistical tests were performed to evaluate the performance of the model. The AUC obtained here in anal cancer is 0.68 [95% CI (0.32-1.00)] with F1 score of 0.78. This signature is TRIPOD level 4 (57%) with an RQS of 61%. This study provides proof of concept that this radiomic signature has the potential to identify a clinically relevant molecular phenotype (i.e., the HPV-ness) across multiple cancers and demonstrates potential for this radiomic signature as a CT imaging biomarker of p16 status.
Topics: Humans; Human Papillomavirus Viruses; Papillomavirus Infections; Prognosis; Oropharyngeal Neoplasms; Anus Neoplasms; Tomography, X-Ray Computed; Retrospective Studies
PubMed: 37137947
DOI: 10.1038/s41598-023-34162-3 -
Medical Care Jun 2023Medications for opioid use disorder (OUD) are known to be effective, especially in reducing the risk of overdose death. Yet, many individuals suffering from OUD are not... (Randomized Controlled Trial)
Randomized Controlled Trial
CONTEXT
Medications for opioid use disorder (OUD) are known to be effective, especially in reducing the risk of overdose death. Yet, many individuals suffering from OUD are not receiving treatment. One potential barrier can be the patient's ability to access providers through their insurance plans.
DATA AND METHODS
We used an audit (simulated patient) study methodology to examine appointment-granting behavior by buprenorphine prescribers in 10 different US states. Trained callers posed as women with OUD and were randomly assigned Medicaid or private insurance status. Callers request an OUD treatment appointment and then asked whether they would be able to use their insurance to cover the cost of care, or alternatively, whether they would be required to pay fully out-of-pocket.
FINDINGS
We found that Medicaid and privately insured women were often asked to pay cash for OUD treatment--40% of the time over the full study sample. Such buprenorphine provider requests happened more than 60% of the time in some states. Areas with more providers or with more generous provider payments were not obviously more willing to accept the patient's insurance benefits for OUD treatment. Rural providers were less likely to require payment in cash in order for the woman to receive care.
CONCLUSIONS
State-to-state variation was the most striking pattern in our field experiment data. The wide variation suggests that women of reproductive age with OUD in certain states face even greater challenges to treatment access than perhaps previously thought; however, it also reveals that some states have found ways to curtail this problem. Our findings encourage greater attention to this public health challenge and possibly opportunities for shared learning across states.
Topics: United States; Humans; Female; Buprenorphine; Prevalence; Opiate Substitution Treatment; Opioid-Related Disorders; Medicaid; Analgesics, Opioid
PubMed: 37083603
DOI: 10.1097/MLR.0000000000001851 -
Radiotherapy and Oncology : Journal of... Jun 2023Timely access to radiotherapy innovations remains suboptimal, partly because there is no commonly agreed appraisal system suitable for the broad range of radiotherapy... (Review)
Review
A systematic literature review of definitions and classification systems for radiotherapy innovation: A first step towards building a value-based assessment tool for radiation oncology.
INTRODUCTION
Timely access to radiotherapy innovations remains suboptimal, partly because there is no commonly agreed appraisal system suitable for the broad range of radiotherapy interventions. The Health Economics in Radiation Oncology (HERO) programme of ESTRO therefore engaged in building a radiotherapy-specific value-based framework. We report on a first step towards that aim, documenting the available definitions and classification systems for radiotherapy interventions.
METHODS
A systematic literature search was carried out in Pubmed and Embase, following PRISMA methodology and using search terms on 'innovation', 'radiotherapy', 'definition' and 'classification'. Data were extracted from articles that met prespecified inclusion criteria.
RESULTS
Out of 13,353 articles, 25 met the inclusion criteria, resulting in the identification of 7 definitions of innovation and 15 classification systems applicable to radiation oncology. Iterative appraisal divided the classification systems into two groups. A first group of 11 systems categorized innovations according to the perceived magnitude of innovation, typically 'minor' versus 'major'. The remaining 4 systems categorised innovations according to radiotherapy-specific characteristics, such as the type of radiation equipment or radiobiological properties. Here, commonly used terms as 'technique' or 'treatment' were found to be used in different meanings.
DISCUSSION
There is no widely accepted definition or classification system for radiotherapy innovations. The data however suggest that unique properties of radiotherapy interventions can be used to categorise innovations in radiation oncology. Still, there remains a need for clear terminology denoting radiotherapy-specific characteristics.
CONCLUSION
Building on this review, the ESTRO-HERO project will define what is required for a radiotherapy-specific value-based assessment tool.
Topics: Humans; Radiation Oncology
PubMed: 36889594
DOI: 10.1016/j.radonc.2023.109602 -
JAMA Cardiology May 2023Ultrasound renal denervation (uRDN) was shown to lower blood pressure (BP) in patients with uncontrolled hypertension (HTN). Establishing the magnitude and consistency...
IMPORTANCE
Ultrasound renal denervation (uRDN) was shown to lower blood pressure (BP) in patients with uncontrolled hypertension (HTN). Establishing the magnitude and consistency of the uRDN effect across the HTN spectrum is clinically important.
OBJECTIVE
To characterize the effectiveness and safety of uRDN vs a sham procedure from individual patient-level pooled data across uRDN trials including either patients with mild to moderate HTN on a background of no medications or with HTN resistant to standardized triple-combination therapy.
DATA SOURCES
A Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN SOLO and TRIO) and A Study of the ReCor Medical Paradise System in Stage II Hypertension (RADIANCE II) trials.
STUDY SELECTION
Trials with similar designs, standardized operational implementation (medication standardization and blinding of both patients and physicians to treatment assignment), and follow-up.
DATA EXTRACTION AND SYNTHESIS
Pooled analysis using individual patient-level data using linear regression models to compare uRDN with sham across the trials.
MAIN OUTCOMES AND MEASURES
The primary outcome was baseline-adjusted change in 2-month daytime ambulatory systolic BP (dASBP) between groups.
RESULTS
A total of 506 patients were randomized in the 3 studies (uRDN, 293; sham, 213; mean [SD] age, 54.1 [9.3]; 354 male [70.0%]). After a 1-month medication stabilization period, dASBP was similar between the groups (mean [SD], uRDN, 150.3 [9.2] mm Hg; sham, 150.8 [10.5] mm Hg). At 2 months, dASBP decreased by 8.5 mm Hg to mean (SD) 141.8 (13.8) mm Hg among patients treated with uRDN and by 2.9 mm Hg to 147.9 (14.6) mm Hg among patients treated with a sham procedure (mean difference, -5.9; 95% CI, -8.1 to -3.8 mm Hg; P < .001 in favor of uRDN). BP decreases from baseline with uRDN vs sham were consistent across trials and across BP parameters (office SBP: -10.4 mm Hg vs -3.4 mm Hg; mean difference, -6.4 mm Hg; 95% CI, -9.1 to -3.6 mm Hg; home SBP: -8.4 mm Hg vs -1.4 mm Hg; mean difference, -6.8 mm Hg; 95% CI, -8.7 to -4.9 mm Hg, respectively). The BP reductions with uRDN vs sham were consistent across prespecified subgroups. Independent predictors of a larger BP response to uRDN were higher baseline BP and heart rate and the presence of orthostatic hypertension. No differences in early safety end points were observed between groups.
CONCLUSIONS AND RELEVANCE
Results of this patient-level pooled analysis suggest that BP reductions with uRDN were consistent across HTN severity in sham-controlled trials designed with a 2-month primary end point to standardize medications across randomized groups.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02649426 and NCT03614260.
Topics: Humans; Male; Middle Aged; Antihypertensive Agents; Sympathectomy; Treatment Outcome; Hypertension; Kidney; Hypotension
PubMed: 36853627
DOI: 10.1001/jamacardio.2023.0338 -
Bulletin of Emergency and Trauma 2023Leech therapy (Hirudotherapy) is a method used in the treatment of many diseases since ancient times. Although many complications have been reported following the use of...
Leech therapy (Hirudotherapy) is a method used in the treatment of many diseases since ancient times. Although many complications have been reported following the use of this method, no systemic life-threatening bleeding has yet been described. A-43-year-old male patient was diagnosed with upper gastrointestinal bleeding following leech application that he had received for infertility one week earlier. The complications of hirudotherapy typically spontaneously improve due to the local effects of this treatment. The most frequently reported complications are local infections, and less commonly allergies and prolonged local bleeding can occur. However, in this case report, we describe a life-threatening upper gastrointestinal bleeding as a new complication. Gastrointestinal bleeding appearing a week after leech therapy does not necessarily mean that leeches caused gastrointestinal bleeding in this case. Nevertheless, considering the development time of gastrointestinal bleeding, it can be deduced that it was possibly due to hirudotherapy. Patients should be informed about alarming symptoms that can indicate complications following leech application.
PubMed: 36818053
DOI: 10.30476/BEAT.2023.97246.1403 -
Plastic Surgery (Oakville, Ont.) Feb 2023Understanding the variables that influence success in digital replant surgery is essential to guide clinical decision-making and to counsel patients. The purpose of...
Understanding the variables that influence success in digital replant surgery is essential to guide clinical decision-making and to counsel patients. The purpose of this study was to determine the replant success rate and identify predictors of success at our tertiary care centre. This was a single centre, retrospective cohort study of consecutive patients who underwent digital replantation from January 2000 to September 2018. Adult patients with flexor zone I to III amputations were included. Patient demographics, comorbidities, injury pattern, operative data, and post-operative care were reviewed. The primary outcome was survival of the replanted digit at discharge. A total of 146 patients met inclusion criteria. Of these, 100 had single-digit replants and 46 underwent multi-digit replants for a total of 220 digits. The success rate was 71%. Predictors of success included sharp mechanism of injury (P < .01), incomplete amputation (P < .01), amputation proximal to zone I flexor level (P = .02), post-operative acetylsalicylic acid use (P < .01), absence of leech use (P = .05), and absence of operative re-exploration (P < .01). Daytime replants had similar outcome compared to nighttime replants despite having increased ischemia time (7.9 ± 3.9 hours vs 6.8 ± 2.6 hours, P = .02). However, daytime operative time (7.8 ± 3.7 hours) was significantly shorter than nighttime replant time (9.6 ± 5.9 hours, P = .01). Sharp amputation, intact venous drainage, proximal amputation, and acetylsalicylic acid use were associated with replant survival and are factors to consider when managing patients for digital replantation. Leech therapy and operative re-exploration were associated with poor outcome. Nighttime replants required significantly longer operative time than daytime replants despite similar survival outcome.
PubMed: 36755824
DOI: 10.1177/22925503211024767 -
Journal of Neuroengineering and... Jan 2023Gait training at fast speeds is recommended to reduce walking activity limitations post-stroke. Fast walking may also reduce gait kinematic impairments post-stroke....
BACKGROUND
Gait training at fast speeds is recommended to reduce walking activity limitations post-stroke. Fast walking may also reduce gait kinematic impairments post-stroke. However, it is unknown if differences in gait kinematics between people post-stroke and neurotypical adults decrease when walking at faster speeds.
OBJECTIVE
To determine the effect of faster walking speeds on gait kinematics post-stroke relative to neurotypical adults walking at similar speeds.
METHODS
We performed a secondary analysis with data from 28 people post-stroke and 50 neurotypical adults treadmill walking at multiple speeds. We evaluated the effects of speed and group on individual spatiotemporal and kinematic metrics and performed k-means clustering with all metrics at self-selected and fast speeds.
RESULTS
People post-stroke decreased step length asymmetry and trailing limb angle impairment, reducing between-group differences at fast speeds. Speed-dependent changes in peak swing knee flexion, hip hiking, and temporal asymmetries exaggerated between-group differences. Our clustering analyses revealed two clusters. One represented neurotypical gait behavior, composed of neurotypical and post-stroke participants. The other characterized stroke gait behavior-comprised entirely of participants post-stroke with smaller lower extremity Fugl-Meyer scores than the post-stroke participants in the neurotypical gait behavior cluster. Cluster composition was largely consistent at both speeds, and the distance between clusters increased at fast speeds.
CONCLUSIONS
The biomechanical effect of fast walking post-stroke varied across individual gait metrics. For participants within the stroke gait behavior cluster, walking faster led to an overall gait pattern more different than neurotypical adults compared to the self-selected speed. This suggests that to potentiate the biomechanical benefits of walking at faster speeds and improve the overall gait pattern post-stroke, gait metrics with smaller speed-dependent changes may need to be specifically targeted within the context of fast walking.
Topics: Humans; Adult; Benchmarking; Gait; Walking; Walking Speed; Lower Extremity; Stroke; Biomechanical Phenomena
PubMed: 36703214
DOI: 10.1186/s12984-023-01139-2