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BMJ Open Jul 2024Persistent symptoms after mild traumatic brain injury (mTBI) negatively affect daily functioning and quality of life. Fear avoidance behaviour, a coping style in which...
INTRODUCTION
Persistent symptoms after mild traumatic brain injury (mTBI) negatively affect daily functioning and quality of life. Fear avoidance behaviour, a coping style in which people avoid or escape from activities or situations that they expect will exacerbate their symptoms, maybe a particularly potent and modifiable risk factor for chronic disability after mTBI. This study will evaluate the efficacy of graded exposure therapy (GET) for reducing persistent symptoms following mTBI, with two primary aims: (1) To determine whether GET is more effective than usual care; (2) to identify for whom GET is the most effective treatment option, by evaluating whether baseline fear avoidance moderates differences between GET and an active comparator (prescribed aerobic exercise). Our findings will guide evidence-based care after mTBI and enable better matching of mTBI patients to treatments.
METHODS AND ANALYSIS
We will conduct a multisite randomised controlled trial with three arms. Participants (n=220) will be recruited from concussion clinics and emergency departments in three Canadian provinces and randomly assigned (1:2:2 ratio) to receive enhanced usual care, GET or prescribed aerobic exercise. The outcome assessment will occur remotely 14-18 weeks following baseline assessment, after completing the 12-week treatment phase. The primary outcome will be symptom severity (Rivermead Post-concussion Symptoms Questionnaire).
ETHICS AND DISSEMINATION
Informed consent will be obtained from all participants. All study procedures were approved by the local research ethics boards (University of British Columbia Clinical Research Ethics Board, University of Calgary Conjoint Health Research Ethics Board, University Health Network Research Ethics Board-Panel D). Operational approvals were obtained for Vancouver Coastal Health Research Institute and Provincial Health Services Authority. If GET proves effective, we will disseminate the GET treatment manual and present instructional workshops for clinicians.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov #NCT05365776.
Topics: Humans; Brain Concussion; Fear; Canada; Implosive Therapy; Avoidance Learning; Quality of Life; Randomized Controlled Trials as Topic; Post-Concussion Syndrome; Male; Multicenter Studies as Topic; Adult; Female
PubMed: 38950993
DOI: 10.1136/bmjopen-2024-086602 -
BMJ Open Jul 2024Amblyopia is a neurodevelopmental vision disorder typically affecting one eye, resulting in compromised binocular function. While evidence-based treatments exist for...
SPEctacle Correction for the TReatment of Amblyopia (SPECTRA): study protocol for a prospective non-randomised interventional trial in adults with anisometropic/mixed mechanism amblyopia.
INTRODUCTION
Amblyopia is a neurodevelopmental vision disorder typically affecting one eye, resulting in compromised binocular function. While evidence-based treatments exist for children, there are no widely accepted treatments for adults. This trial aims to assess the efficacy of appropriate optical treatment in improving vision and visual functions in adults with amblyopia. This is hypothesised to significantly improve visual acuity of the amblyopic eye and other visual functions.
METHODS AND ANALYSIS
SPEctacle Correction for the TReatment of Amblyopia is a prospective non-randomised interventional trial. The following criteria for amblyopia will be used: best corrected visual acuity (BCVA) in the amblyopic eye of 0.3 to 1.0 (inclusive) logMAR VA and in the fellow eye, 0.1 logMAR or better, with an interocular VA difference of ≥2 logMAR lines. Eligible participants aged 18-39 will receive full/near-full optical treatment requiring wear for at least half their waking hours for the trial duration. A difference of ≥1.00D spherical equivalent between a participant's current refractive correction and the study prescription is required for eligibility. Primary outcome is the change in amblyopic eye BCVA from baseline to 24-week postenrolment. Secondary outcomes include distance and near VA of both eyes, stereoacuity, contrast sensitivity, interocular suppression, angle of strabismus and fixation stability measured at monthly intervals. Visual evoked potentials will also be measured at baseline, week 12 and week 24. Treatment compliance and quality of life for all participants will be monitored.Analyses comparing baseline and week 24 will utilise pairwise comparisons. Linear mixed models will be fitted to the data for measures taken monthly. This allows estimates and inferences to be drawn from the coefficients of the model, while handling missing data.
ETHICS AND DISSEMINATION
Human ethics approval was obtained from the respective ethics board of the Hong Kong Polytechnic University (HSEARS20210915002) and the University of Waterloo (#44235). The study protocol will conform to the principles of the Declaration of Helsinki. Results will be disseminated through peer-reviewed journals and conferences.
TRIAL REGISTRATION NUMBER
NCT05394987; clinicaltrials.org.
Topics: Humans; Amblyopia; Eyeglasses; Visual Acuity; Prospective Studies; Adult; Young Adult; Adolescent; Male; Female; Treatment Outcome; Non-Randomized Controlled Trials as Topic; Vision, Binocular
PubMed: 38950991
DOI: 10.1136/bmjopen-2023-080151 -
BMJ Open Jul 2024Orthodontic treatment using face mask protraction combined with an alternate rapid maxillary expansion and constriction/protraction face mask (Alt-RAMEC/PFM) protocol is...
Impact of tonsillectomy on the efficacy of Alt-RAMEC/PFM treatment protocols in children with class III malocclusion and tonsillar hypertrophy: protocol for a cluster randomised controlled trial.
INTRODUCTION
Orthodontic treatment using face mask protraction combined with an alternate rapid maxillary expansion and constriction/protraction face mask (Alt-RAMEC/PFM) protocol is effective in the early treatment of patients with class III malocclusion, but the stability of treatment outcomes represents a major concern. Previous studies have suggested that tonsillar hypertrophy can be a risk factor for class III malocclusion and tonsillectomy may prompt the normalisation of dentofacial growth. However, these studies had a low-to-moderate level of evidence. This study was designed to identify the impact of tonsillectomy before orthodontic treatment on the efficacy and stability of Alt-RAMEC/PFM protocols and the sleep quality and oral health in children with anterior crossbite and tonsillar hypertrophy.
METHODS AND ANALYSIS
This is a two-arm, parallel-group, superiority cluster randomised controlled trial, with four clinics randomly assigned to the surgery-first arm and the orthodontic-first arm in a 1:1 ratio. The Alt-RAMEC protocol involves alternate activation and deactivation of the expander's jet screw over 6 weeks to stimulate maxillary suture distraction. Patients will be instructed to wear the PFM for a minimum of 14 hours per day. The primary outcomes are changes in Wits appraisal and the degree of maxillary advancement from baseline to the end of orthodontic treatment. Lateral cephalometric radiographs, polysomnography, Obstructive Sleep Apnoea-18 questionnaire and Oral Health Impact Profile-14 questionnaire will be traced, collected and measured. We will recruit 96 patients intofor the study. To assess differences, repeated multilevel linear mixed modelling analyses will be used.
ETHICS AND DISSEMINATION
This study has been granted ethical approval by the Ethics Committee of the School & Hospital of Stomatology, Wuhan University (approval No. 2023-D10). Written informed consent will be obtained from the participants and their guardians. The results of the trial will be disseminated through academic conferences and journal publications.
TRIAL REGISTRATION NUMBER
ChiCTR2300078833.
Topics: Humans; Tonsillectomy; Child; Malocclusion, Angle Class III; Palatine Tonsil; Palatal Expansion Technique; Hypertrophy; Female; Extraoral Traction Appliances; Randomized Controlled Trials as Topic; Male; Treatment Outcome; Sleep Quality; Adolescent
PubMed: 38950988
DOI: 10.1136/bmjopen-2024-084703 -
BMJ Open Jul 2024Spirometry is a point-of-care lung function test that helps support the diagnosis and monitoring of chronic lung disease. The quality and interpretation accuracy of... (Randomized Controlled Trial)
Randomized Controlled Trial
Comparing performance of primary care clinicians in the interpretation of SPIROmetry with or without Artificial Intelligence Decision support software (SPIRO-AID): a protocol for a randomised controlled trial.
INTRODUCTION
Spirometry is a point-of-care lung function test that helps support the diagnosis and monitoring of chronic lung disease. The quality and interpretation accuracy of spirometry is variable in primary care. This study aims to evaluate whether artificial intelligence (AI) decision support software improves the performance of primary care clinicians in the interpretation of spirometry, against reference standard (expert interpretation).
METHODS AND ANALYSIS
A parallel, two-group, statistician-blinded, randomised controlled trial of primary care clinicians in the UK, who refer for, or interpret, spirometry. People with specialist training in respiratory medicine to consultant level were excluded. A minimum target of 228 primary care clinician participants will be randomised with a 1:1 allocation to assess fifty de-identified, real-world patient spirometry sessions through an online platform either with (intervention group) or without (control group) AI decision support software report. Outcomes will cover primary care clinicians' spirometry interpretation performance including measures of technical quality assessment, spirometry pattern recognition and diagnostic prediction, compared with reference standard. Clinicians' self-rated confidence in spirometry interpretation will also be evaluated. The primary outcome is the proportion of the 50 spirometry sessions where the participant's preferred diagnosis matches the reference diagnosis. Unpaired t-tests and analysis of covariance will be used to estimate the difference in primary outcome between intervention and control groups.
ETHICS AND DISSEMINATION
This study has been reviewed and given favourable opinion by Health Research Authority Wales (reference: 22/HRA/5023). Results will be submitted for publication in peer-reviewed journals, presented at relevant national and international conferences, disseminated through social media, patient and public routes and directly shared with stakeholders.
TRIAL REGISTRATION NUMBER
NCT05933694.
Topics: Humans; Spirometry; Artificial Intelligence; Primary Health Care; Randomized Controlled Trials as Topic; Software; United Kingdom; Decision Support Systems, Clinical
PubMed: 38950987
DOI: 10.1136/bmjopen-2024-086736 -
Journal of Neurosurgery. Case Lessons Jul 2024Neurolymphomatosis (NL) is a rare disease defined as an invasion of lymphoma into peripheral nerves, nerve roots, or nerve plexuses, including the cranial nerves. No...
BACKGROUND
Neurolymphomatosis (NL) is a rare disease defined as an invasion of lymphoma into peripheral nerves, nerve roots, or nerve plexuses, including the cranial nerves. No clear treatment protocols have yet been defined for this pathology.
OBSERVATIONS
A woman in her 40s had a primary central nervous system lymphoma diagnosed from an intracranial tumor biopsy and underwent chemotherapy and radiation therapy. After she complained of pain in the trunk and extremities, magnetic resonance imaging and [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET) performed 25 months after initial diagnosis revealed multiple lesions in the nerve ganglia, plexuses, and peripheral nerves from the cervical to the sacral spinal cord. Cerebrospinal fluid cytology revealed atypical lymphocytes and lymphoma dissemination in the spinal cavity. Based on these findings, NL was diagnosed. An intrathecal antineoplastic regimen temporarily reduced abnormal uptake of FDG, but the lesion recurred. After additional high-dose methotrexate therapy, FDG accumulation in the previously identified lesions disappeared. However, peripheral neuropathic pain and paraplegia remained. The patient died 9 months after the initial diagnosis of NL.
LESSONS
The authors reported a case of NL following primary central nervous system lymphoma. In this case, FDG-PET proved useful for diagnosis, and high-dose methotrexate therapy was temporarily effective. https://thejns.org/doi/suppl/10.3171/CASE24107.
PubMed: 38950432
DOI: 10.3171/CASE24107 -
Implementation of the São Paulo Nursing Courses Consortium for the Progress Test: experience report.Revista Da Escola de Enfermagem Da U S P 2024To report the experience of implementing the São Paulo Nursing Courses Consortium for the Progress Test.
OBJECTIVE
To report the experience of implementing the São Paulo Nursing Courses Consortium for the Progress Test.
METHOD
This is an experience report of the consortium's work in Progress Test preparation and application for Public Schools of Nursing in São Paulo in 2019, 2021 and 2022, with a descriptive analysis of the work process and the results obtained.
RESULTS
The consortium's activities are structured into the following stages: planning; theme review; distributing and requesting questions; professor training; question elaboration; question reception; question selection; question validation; student registration; test application; analysis and dissemination of results. A total of 57.3% of enrolled students participated. There was a predominance of questions of medium difficulty and a gradual progression in the level of discrimination of the questions, with, in 2022, 82.5% being considered adequate.
FINAL CONSIDERATIONS
The consortium has allowed the test to be applied interinstitutionally, with greater scope, accuracy, and quality of questions. Through this experience, it is expected to encourage progress testing in undergraduate nursing courses in other contexts.
Topics: Brazil; Humans; Students, Nursing; Educational Measurement; Education, Nursing, Baccalaureate; Education, Nursing; Schools, Nursing
PubMed: 38949510
DOI: 10.1590/1980-220X-REEUSP-2023-0347en -
Clinical, Cosmetic and Investigational... 2024Vitiligo has been reported to occur in association with lupus erythematosus (LE) and other autoimmune diseases. However, it remains unclear whether this association...
Vitiligo has been reported to occur in association with lupus erythematosus (LE) and other autoimmune diseases. However, it remains unclear whether this association occurs because of shared immunopathogenesis. We hereby describe a case of discoid lupus erythematosus (DLE) in a 51-year-old man with a 3 years history of skin lesions on his face, arms, and the V zone of the neck, and with the coexistence of vitiligo for 12 years, who developed from DLE to hypertrophic discoid lupus erythematosus (HDLE) after 10 months. We reviewed the previously reported cases to summarize the clinical characteristics of these patients and hope it may provide a reference for dermatologists.
PubMed: 38948921
DOI: 10.2147/CCID.S475002 -
Contemporary Clinical Trials... Jun 2024Post-stroke spasticity (PSS) is among the prevalent complications of stroke, greatly affecting motor function recovery and reducing patients' quality of life without...
INTRODUCTION
Post-stroke spasticity (PSS) is among the prevalent complications of stroke, greatly affecting motor function recovery and reducing patients' quality of life without timely treatment. Sangdantongluo granule, a modern traditional Chinese patent medicine, has significant clinical efficacy in treating PSS. However, the mechanism of Sangdantongluo granule in treating PSS is still unknown. We designed this study to explore the mechanism of Sangdantongluo granule in treating PSS through multimodal functional magnetic resonance imaging (fMRI) combined with transcranial magnetic stimulation (TMS).
METHODS AND ANALYSIS
In a single-center, randomized, double-blind, parallel placebo-controlled study, 60 PSS patients will be recruited in China and randomly assigned to either the experimental or control groups at a ratio of 1:1. For eight weeks, Sangdantongluo granule or placebo will be utilized for intervention. The main outcome is the Modified Ashworth Scale (MAS), the secondary outcome includes the Fugl-Meyer Assessment Scale-upper Extremity (FMA-UE), National Institute of Health Stroke Scale (NIHSS), and Modified Rankin Scale (mRS), the mechanism measure is the changes in cortical excitability and multimodal fMRI at baseline and after eight weeks.
ETHICS AND DISSEMINATION
This study was approved by the Ethics Committee of the Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine (approval number: [202364]).
CLINICAL TRIAL REGISTRATION
Chinese Clinical Trial Registry, identifier: ChiCTR2300074793. Registered on 16 August 2023.
PubMed: 38948333
DOI: 10.1016/j.conctc.2024.101317 -
IDCases 2024Rhinosporidiosis is one of the granulomatous diseases endemic in Asia, Africa, and Europe, with Southern India and Sri Lanka having the greatest prevalence rates. It is...
Rhinosporidiosis is one of the granulomatous diseases endemic in Asia, Africa, and Europe, with Southern India and Sri Lanka having the greatest prevalence rates. It is typically understood to affect the upper respiratory system. Involvement of the lungs beyond the trachea is infrequent as compared to the upper respiratory tract. We revealed an uncommon case of disseminated rhinosporidiosis in a diabetic patient, who initially presented with shortness of breath associated with cough and fever. Two months prior to these symptoms, he was having oral ulcer and dysphagia and, subsequently, loss of weight. Chest radiograph and CT thorax revealed military nodules with multiple suppurative neck and mediastinal lymphadenopathy and bilateral adrenal lesions. He was initially investigated for tuberculosis, metastatic malignancy, or lymphangitic carcinomatosis before a biopsy revealed Rhinosporidiosis. Hence, histopathological or laboratory evidence is frequently crucial to back up imaging concerns so the appropriate treatment can be given.
PubMed: 38947561
DOI: 10.1016/j.idcr.2024.e02009 -
Heliyon Jun 2024A middle-aged gentleman, presented to our outpatient department with painful skin lesions suggestive of disseminated herpes zoster. Further examination revealed...
A middle-aged gentleman, presented to our outpatient department with painful skin lesions suggestive of disseminated herpes zoster. Further examination revealed bilateral cerebellar signs. He had a history of receiving a third dose of AZD1222 vaccine fourteen days prior to the onset of skin lesions but had no other significant medical history. The patient was also evaluated for retroviral infection and other immunodeficient states, workup for which were negative. The patient was initially treated with intravenous acyclovir 7.5 mg/kg/q8H; however, the patient developed varicella encephalitis on treatment, which was followed by pneumonia and haemorrhagic cystitis. Subsequently, treatment was started with acyclovir 10 mg/kg/q8H for 14 days, followed by valacyclovir for eight days, following which there was near-complete resolution of symptoms with the persistence of minimal rigidity. Although there have been several reports of herpes zoster following SARS-CoV-2 vaccination, we found few reports of varicella zoster with systemic manifestations following ChAdOx1 nCoV-19 (AZD1222) vaccination. This case highlights the importance of considering varicella zoster reactivation in a patient presenting with encephalitis or pneumonia post SARS-CoV-2 vaccination.
PubMed: 38947434
DOI: 10.1016/j.heliyon.2024.e32248