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OBJECTIVES: Our study aimed to investigate the feasibility of using high-density surface electromyography (HD-sEMG) for swallowing assessment by comparing the quantitative parameters and topographic patterns of HD-sEMG between post-irradiated patients and healthy individuals. METHODS: Ten healthy volunteers and ten post-irradiated nasopharyngeal carcinoma patients were recruited. 96-channel HD-sEMG was recorded although each participant consumed different consistencies of food (thin and thick liquid, puree, congee, and soft rice). Dynamic topography was generated from the root mean square (RMS) of the HD-sEMG signals to illustrate the anterior neck muscle function in the swallowing process. The averaged power of muscles and the symmetry of swallowing patterns were assessed by objective parameters including average RMS, Left/Right Energy Ratio, and Left/Right Energy Difference. RESULTS: The study showed different swallowing patterns between patients with dysphagia and healthy individuals. The mean RMS values were higher in the patient group compared to the healthy group, but the difference was not statistically significant. Asymmetrical patterns were shown in patients with dysphagia. CONCLUSION: HD-sEMG is a promising technique that could be used to quantitatively evaluate the average power of neck muscles and the symmetry of swallowing activities in patients with swallowing difficulties. LEVEL OF EVIDENCE: Level 3 Laryngoscope, 133:2920-2928, 2023.
Subject(s)
Deglutition Disorders , Humans , Electromyography/methods , Deglutition Disorders/diagnosis , Deglutition Disorders/etiology , Deglutition/physiology , Neck Muscles , Muscle ContractionABSTRACT
Puree is commonly prescribed for patients with mastication and bolus formation difficulties, but its appearance might negatively impact appetite and intake. Molded puree is marketed to be an alternative to traditional puree, but the process of molding puree could alter the properties of the food significantly and lead to different swallowing physiology as compared to puree. The current study investigated the differences between traditional and molded puree in terms of swallowing physiology and perception in healthy individuals. Thirty two participants were included. Two outcomes were used to quantify the oral preparatory and oral phase. Fibreoptic endoscopic evaluation of swallowing was used to assess the pharyngeal phase as it could retain the purees in their original form. Six outcomes were collected. Perceptual rating of the purees were provided by participants in six domains. Molded puree required significantly more masticatory cycles (p < 0.001) and longer time for ingestion (p < 0.001). Molded puree had longer swallow reaction time (p = 0.001) and more inferior site of swallow initiation (p = 0.007) compared with traditional puree. Participants' satisfaction with the appearance, texture and overall of molded puree was significantly greater. Molded puree was perceived to be more difficult to chew and swallow. This study established that the two types of puree were different in various aspects. The study also provided important clinical implications regarding the use of molded puree as a form of texture modified diet (TMD) in patients with dysphagia. The results could serve as the foundation of larger cohort studies on the effect of various TMDs on patients with dysphagia.
Subject(s)
Deglutition Disorders , Deglutition , Endoscopy , Humans , Deglutition/physiology , Deglutition Disorders/diagnostic imaging , Deglutition Disorders/etiology , Food , PharynxABSTRACT
Carbapenemase-producing Enterobacterales (CPE) infection control practices are based on the paradigm that detected carriers in the hospital transmit to other patients who stay in the same ward. The role of plasmid-mediated transmission at population level remains largely unknown. In this retrospective cohort study over 4.7 years involving all multi-disciplinary public hospitals in Singapore, we analysed 779 patients who acquired CPE (1215 CPE isolates) detected by clinical or surveillance cultures. 42.0% met putative clonal transmission criteria, 44.8% met putative plasmid-mediated transmission criteria and 13.2% were unlinked. Only putative clonal transmissions associated with direct ward contact decreased in the second half of the study. Both putative clonal and plasmid-mediated transmission associated with indirect (no temporal overlap in patients' admission period) ward and hospital contact did not decrease during the study period. Indirect ward and hospital contact were identified as independent risk factors associated with clonal transmission. In conclusion, undetected CPE reservoirs continue to evade hospital infection prevention measures. New measures are needed to address plasmid-mediated transmission, which accounted for 50% of CPE dissemination.
Subject(s)
Enterobacteriaceae Infections , Gammaproteobacteria , Bacterial Proteins , Enterobacteriaceae Infections/microbiology , Enterobacteriaceae Infections/transmission , Gammaproteobacteria/genetics , Humans , Retrospective Studies , Whole Genome Sequencing , beta-Lactamases/geneticsABSTRACT
The International Dysphagia Diet Standardization Initiative (IDDSI) proposed the flow test (FT) as a simple method for measuring the viscosity of thickened liquids. However, the FT specifies the use of a particular syringe type (BD-Slip), which is unfortunately not easily available in Japan. Therefore, the current study primarily aimed to investigate the effects of the internal syringe shape on IDDSI FT and identify the most suitable syringe available in Japan for xanthan gum-based thickened liquids. Accordingly, four syringes, namely, Luer slip tip, Luer-Lok tip, TERUMO, and NIPRO syringes, were used to examine FT value with water and nine different water viscosity levels. The correlation and systematic errors on residual FT values between the BD-Slip syringe and the other three syringes were analyzed. The two-dimensional internal shapes of the four syringes were measured using industrial computed tomography (CT) scanning. Based on the results of our FT, TERUMO had the smallest error range among the three syringes, without systematic errors. On a CT scan, three of five tip-shape parameters showed the smallest difference between BD-Slip and TERUMO syringe. Therefore, TERUMO had the smallest FT error range compared with that in BD-Slip tip syringe, indicating that TERUMO could be used as a substitute for BD-Slip when performing IDDSI FT with xanthan gum-based thickened water in Japan.
Subject(s)
Deglutition Disorders , Diet , Humans , Reference Standards , Syringes , WaterABSTRACT
BACKGROUND: Problems with pharyngo-esophageal bolus flow have been reported following nasopharyngeal cancer (NPC) treatment. While studies using videofluoroscopic assessment have shown balloon dilation can help address this impairment, the impact of dilation on pressure and bolus flow characteristics incorporating high-resolution pharyngeal manometry (HRPM) has not been reported. METHODS: Five cases with pharyngo-esophageal dysphagia post NPC underwent balloon dilation. Videofluoroscopic swallowing study (VFSS) and HRPM were completed before and 1 month post dilation. Oral intake and dysphagia related quality of life were reported to 3 months. RESULTS: VFSS, manometry and functional outcomes revealed positive benefits from dilation in two cases. In the other three cases, two showed improvements on VFSS only. These three failed to make functional swallowing gains. CONCLUSIONS: Where there was functional gain, both fluoroscopy and HRPM recorded improvement to UES function. Across the cases, response to dilation was variable and further work is needed to determine which patients would receive most benefit. LEVEL OF EVIDENCE: 4.
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OBJECTIVE: To investigate changes in the median nerve, retinaculum, and carpal tunnel on ultrasound after successful endoscopic carpal tunnel release (ECTR). MATERIALS AND METHODS: This prospective study involved 37 wrists in 35 patients (5 male, 30 female; mean age ± standard deviation [SD], 56.9 ± 6.7 years) with primary carpal tunnel syndrome (CTS). An in-house developed scoring system (0-3) was used to gauge the clinical improvement after ECTR. Ultrasound was performed before ECTR, and at 1, 3, and 12 months post-ECTR. Changes in the median nerve, flexor retinaculum, and carpal tunnel morphology on ultrasound after ECTR were analyzed. Ultrasound parameters for different clinical improvement groups were compared. RESULTS: All patients improved clinically after ECTR. The average clinical improvement score ± SD at 12 months post-ECTR was 2.2 ± 0.7. The median nerve cross-sectional area proximal and distal to the tunnel decreased at all time intervals post-ECTR but remained swollen compared to normal values. Serial changes in the median nerve caliber and retinacular bowing after ECTR were more pronounced at the tunnel outlet than at the tunnel inlet. The flexor retinaculum had reformed in 25 (68%) of 37 wrists after 12 months. CONCLUSION: Postoperative changes in median nerve and retinaculum parameters were most pronounced at the tunnel outlet. Even in patients with clinical improvement after ECTR, nearly all ultrasound parameters remain abnormal at one year post-ECTR. These ultrasound parameters should not necessarily be relied upon to diagnose persistent CTS after ECTR.
Subject(s)
Carpal Tunnel Syndrome , Carpal Tunnel Syndrome/diagnostic imaging , Carpal Tunnel Syndrome/surgery , Female , Humans , Male , Median Nerve/diagnostic imaging , Median Nerve/surgery , Middle Aged , Prospective Studies , Ultrasonography , Wrist/diagnostic imaging , Wrist/surgeryABSTRACT
PURPOSE: This study assessed effectiveness and safety of the novel Clareon intraocular lens (IOL; model SY60CL; Alcon Vision LLC). PATIENTS AND METHODS: This was a prospective, single-arm, unmasked clinical trial at 16 investigative clinical sites in the United States. Included were adults ≥22 years who required cataract extraction by phacoemulsification. Following phacoemulsification, 350 subjects received SY60CL IOL unilaterally; 342 completed the study. Monocular best corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA) were evaluated. The primary effectiveness endpoint was the percentage of subjects with CDVA ≤0.3 logMAR at month 12. Safety was assessed by monitoring adverse events (AEs). Visual acuity and safety outcomes were compared with historical safety and performance endpoint (SPE) rates. RESULTS: At 12 months post-implantation, 99.7% of subjects receiving the SY60CL IOL achieved monocular CDVA ≤0.3 logMAR (primary effectiveness endpoint; 1-sided 95% upper confidence limit >SPE rate); 99.7% and 86.8% of subjects achieved monocular CDVA of ≤0.34 (20/40 Snellen or better) and ≤0.04 logMAR (20/20 Snellen or better), respectively. At 12 months, >95% of subjects achieved mean monocular UDVA ≤0.3 logMAR; 97.1% and 57.6% of subjects achieved monocular CDVA of ≤0.34 and ≤0.04 logMAR, respectively. Mean monocular CDVA and UDVA were -0.05 and 0.04 logMAR, respectively. AEs were within SPE limits. The most common nonserious ocular AE was posterior capsule opacification (5.4%). Serious AEs were <1%, and no serious ocular AEs were assessed as related to the device. There were no observations for IOL glistenings at 12 months. CONCLUSION: Results of this study supported effectiveness and safety of the SY60CL IOL. Visual acuity outcomes with the SY60CL IOL exceeded the SPE rates for monocular CDVA and AEs were within the limit of historic SPE rates. (Model number SY60WF is the Clareon lens approved by the FDA.).
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Introduction: The aim of this study was to investigate the accelerated emergence of telepractice in speech language pathology during the coronavirus disease 2019 (COVID-19) pandemic in Hong Kong-a small city with limited accessibility concern that telepractice has not been widely implemented. Method: An online survey of speech therapists in Hong Kong was conducted between February and March in 2020. The survey comprised up to 15 questions to assess participants' demographics, existing service delivery in telepractice, perception, and their training and knowledge on telepractice. Results: One hundred thirty-five speech (n = 135) speech language pathologists responded to the survey. About one-third (34.8%; n = 47) of participants reported having provided services through telepractice, whereas 72.3% of them started in <3 months and half of them considered it was less effective than face-to-face service. Among the other participants (n = 88), 83% of them indicated that unsuitable patient type and age as the main reason for not providing telepractice. The majority of participants had no prior training for delivering telepractice, and focused on technology when asked about their desired training. Knowledge of participants on telepractice was found only to align fairly with international guidelines. Discussions: The survey findings suggested that telepractice provision in Hong Kong was different from that of other countries where telepractice has been well established, due to the accelerated emergence by the COVID-19 pandemic. Conclusions: The study showed how the development of telepractice would be like in a short time frame, and findings on perception and desired training could be a reference for a better establishment of this model of service.
Subject(s)
COVID-19/epidemiology , Language Therapy/psychology , Speech Therapy/psychology , Speech-Language Pathology/organization & administration , Telemedicine/organization & administration , Adolescent , Adult , Age Factors , Aged , Attitude of Health Personnel , Child , Child, Preschool , Hong Kong/epidemiology , Humans , Infant , Inservice Training , Middle Aged , Pandemics , SARS-CoV-2 , Socioeconomic Factors , Young AdultABSTRACT
Objective: Migrant workers, a marginalized and under-resourced population, are vulnerable to coronavirus disease 2019 (COVID-19) due to limited healthcare access. Moreover, metabolic diseases-such as diabetes mellitus (DM), hypertension, and hyperlipidemia-predispose to severe complications and mortality from COVID-19. We investigate the prevalence and consequences of undiagnosed metabolic illnesses, particularly DM and pre-diabetes, in international migrant workers with COVID-19. Methods: In this retrospective analysis, we analyzed the medical records of international migrant workers with laboratory-confirmed COVID-19 hospitalized at a tertiary hospital in Singapore from April 21 to June 1, 2020. We determined the prevalence of DM and pre-diabetes, and analyzed the risk of developing complications, such as pneumonia and electrolyte abnormalities, based on age and diagnosis of DM, and pre-diabetes. Results: Two hundred and fouty male migrant workers, with mean age of 44.2 years [standard deviation (SD), 8.5years], were included. Twenty one patients (8.8%) were diagnosed with pre-diabetes, and 19 (7.9%) with DM. DM was poorly controlled with a mean HbA1c of 9.9% (SD, 2.4%). 73.7% of the patients with DM and all the patients with pre-diabetes were previously undiagnosed. Pre-diabetes was associated with higher risk of pneumonia [odds ratio (OR), 10.8, 95% confidence interval (CI), 3.65-32.1; P < 0.0001], hyponatremia (OR, 8.83; 95% CI, 1.17-66.6; P = 0.0342), and hypokalemia (OR, 4.58; 95% CI, 1.52-13.82; P = 0.0069). Moreover, patients with DM or pre-diabetes developed COVID-19 infection with lower viral RNA levels. Conclusions: The high prevalence of undiagnosed pre-diabetes among international migrant workers increases their risk of pneumonia and electrolyte abnormalities from COVID-19.
Subject(s)
COVID-19 , Diabetes Mellitus , Prediabetic State , Transients and Migrants , Undiagnosed Diseases , Adult , COVID-19/diagnosis , COVID-19/epidemiology , Diabetes Mellitus/diagnosis , Diabetes Mellitus/epidemiology , Humans , Male , Middle Aged , Prediabetic State/diagnosis , Prediabetic State/epidemiology , Retrospective Studies , Risk Assessment , SARS-CoV-2/isolation & purification , Singapore/epidemiology , Transients and Migrants/statistics & numerical data , Undiagnosed Diseases/epidemiology , Young AdultABSTRACT
The global 2019 novel coronavirus disease (COVID-19) pandemic has had devastating effects not only on healthcare systems worldwide but also on different aspects of the care provided to nursing home residents. Dysphagia management is a crucial component of the care provided to many nursing home residents. This article presents the dysphagia management strategies applied in Hong Kong during the COVID-19 pandemic and the related experiences. A two-tier protection system was implemented wherein residents were categorised according to their contact and hospitalisation histories. The provided swallowing management and personal protective equipment level differed between the two tiers. The article also discusses the referral and prioritisation of clinical services for residents requiring swallowing management, as well as the adaptations of swallowing assessment and management during the pandemic. The possible effects of COVID-19 on mealtime arrangements in nursing homes, the implications of the pandemic on the use of personal protective equipment and the use of telepractice in nursing homes were also discussed. This article has summarised the actions taken in this regard and may serve as a reference to clinicians who are responsible for swallowing assessments and dysphagia management in nursing homes.
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PURPOSE: To investigate the accuracy of ultrasound in characterising the type of mass and likelihood of malignancy in deep soft tissue masses. METHODS: Five hundred seventy-nine deep soft tissue masses were prospectively studied by ultrasound. Masses (n = 137) with prior MRI or CT were not included. Following ultrasound examination, the likely nature of the mass as well as the confidence of the reporting radiologist ('fully confident' versus 'not fully confident') about the ultrasound diagnosis was recorded. Clinical and ultrasound diagnoses were compared with the histological diagnosis which was available in 134 (23%) of the 579 masses. RESULTS: Compared with histology, clinical and ultrasound accuracy for characterising the type of mass were 47% and 88% respectively when all differential diagnoses were considered. The radiologist was fully confident regarding the type of 436 (75%) of 579 masses and, in this setting, for those cases that could be compared with histology, diagnostic accuracy was 96%. For the remaining masses, where the radiologist was not fully confident, accuracy compared with histology was 58% for the first differential diagnosis and 80% for all differential diagnoses. For identifying malignancy, sensitivity, specificity, and positive and negative predictive value of ultrasound were 97%, 58%, 67%, and 99% respectively. Ultrasound alone was considered sufficient for diagnostic workup in over half of all deep soft tissue masses. CONCLUSION: Ultrasound is useful at characterising and recognising malignancy in deep soft tissue masses. Provided local practice patterns are favourable, ultrasound may be considered a first-line investigation in the diagnostic workup of deep soft tissue masses. KEY POINTS: ⢠In three-quarters of cases, one can be fully confident about characterising the nature of deep soft tissue masses on ultrasound and, for those fully confident cases that could be compared with histology, the diagnostic accuracy of ultrasound was 96%. ⢠Ultrasound can correctly recognise nearly all malignant deep soft tissue masses but some benign masses will also be considered possibly malignant. ⢠Ultrasound alone was considered sufficient for imaging workup in over half of deep soft tissue masses.
Subject(s)
Soft Tissue Neoplasms/diagnosis , Ultrasonography/methods , Diagnosis, Differential , Female , Humans , Male , Middle Aged , Prospective Studies , Reproducibility of ResultsABSTRACT
OBJECTIVE: Nasopharyngeal cancer (NPC) has distinct characteristics regarding its global prevalence, initial presentation, management and patient outcomes compared to other subtypes of head and neck cancer (HNC). The mainstay of NPC treatment is chemo-radiation (C/RT) and while dysphagia is a known early and late toxicity of C/RT treatment, the nature of dysphagia post NPC treatment has had limited investigation. The objective of this review is to summarise the existing evidence regarding dysphagia following NPC to inform the future research agenda for this population. Dysphagia incidence, characteristic deficits observed across the phases of swallowing, efficacy of current dysphagia interventions, and effect on quality of life will be explored. DATA SOURCES: Databases including MEDLINE, CINAHL, Embase, Scopus and Web of Science were included. METHODS: A scoping review was conducted according to PRISMA-ScR guidelines. Two independent reviewers screened selected full text articles. RESULTS: Of the initial 2495 articles found, 28 articles were included. Reports of penetration and aspiration varied widely (0%-91.6%), with high rates of silent aspiration identified in 2 studies (42%, 66%). Oral, pharyngeal and upper esophageal phase impairments were reported. Of these, upper esophageal stasis and multiple pharyngeal stage deficits were most prevalent. The pharyngeal constrictors were found to have a significant dose-effect relationship and shielding to the anterior neck field was effective to preserve swallowing function. Six treatment studies were identified with limited evidence supporting the use of neuromuscular electrical stimulation, dilatation and swallowing exercises. Quality of life was adversely affected. CONCLUSIONS: Dysphagia is a prevalent early and late problem post NPC treatment, with impairments across all phases of the swallow. Studies on preventing dysphagia and treatment efficacy remain limited. More systematic study of the nature of dysphagia and the efficacy of treatment in this population is warranted.
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Saksenaea vasiformis complex is an emerging cause of mucormycosis. We report a case of an immunocompetent patient presenting with a non-resolving lung mass who developed multiple skin nodules. Skin biopsy yielded Saksenaea vasiformis complex. This showcases an uncommon occurrence of disseminated Saksenaea infection without cutaneous inoculation that improved with posaconazole.
Subject(s)
Antifungal Agents/therapeutic use , Mucormycosis/drug therapy , Triazoles/therapeutic use , Aged , Asian People , Back , Follow-Up Studies , Forehead , Humans , Immunocompetence , Male , Mucormycosis/diagnostic imaging , Positron Emission Tomography Computed Tomography , Singapore , Skin/microbiology , Skin/pathology , Thorax , Tomography, X-Ray ComputedABSTRACT
At present, the nature and extent of upper esophageal stage clearance issues following nonsurgical management of nasopharyngeal cancer (NPC) is not well elucidated. The aim of this study was to conduct an initial retrospective study of the prevalence and severity of upper esophageal clearance impairments in a cohort of patients post-NPC management. A secondary aim was to explore any observed relationship between severity of impairment with both (a) aspiration and (b) temporal oropharyngeal swallowing measures. A cohort of 134 NPC patients who received curative intent (chemo)radiotherapy (C/RT) and completed a videofluoroscopic swallowing study (VFSS) between 2012 and 2015 were reviewed. An Esophageal Clearance parameter, based on the scale used in MBSImP was used to classify the presence and severity of esophageal impairment on thin liquid and semisolids. Data on oral and pharyngeal temporal measures, pharyngeal constriction, and penetration/aspiration were also collected. The prevalence of cervical esophageal clearance impairment was high with ratings > 0 observed among 83% and 97% of patients on thin liquid and semisolids, respectively. With the increasing impairment, significantly (p < 0.05) increased oral transit times were observed for liquid swallows, and increased pharyngeal transit times for semisolids. Significantly higher proportions of patients presented with penetration/aspiration in the group with more severe esophageal clearance impairment. Results confirm that cervical esophageal clearance impairment is highly prevalent post-C/RT treatment for NPC. Causality cannot be determined from this study; however, this initial evidence supports that esophageal impairment may coexist in patients post NPC, presenting with more severe oral/pharyngeal deficits, and the impact of this on swallow function needs to be considered. Further systematic research is required.
Subject(s)
Chemoradiotherapy/adverse effects , Deglutition Disorders/epidemiology , Nasopharyngeal Carcinoma/physiopathology , Nasopharyngeal Neoplasms/physiopathology , Respiratory Aspiration/epidemiology , Aged , Cineradiography , Deglutition , Deglutition Disorders/diagnosis , Deglutition Disorders/etiology , Esophagus/diagnostic imaging , Esophagus/physiopathology , Female , Humans , Male , Middle Aged , Nasopharyngeal Carcinoma/therapy , Nasopharyngeal Neoplasms/therapy , Neck/diagnostic imaging , Neck/physiopathology , Oropharynx/diagnostic imaging , Oropharynx/physiopathology , Prevalence , Respiratory Aspiration/diagnosis , Respiratory Aspiration/etiology , Retrospective StudiesABSTRACT
Carbapenem-resistant Enterobacteriaceae (CRE) can be mechanistically classified into carbapenemase-producing Enterobacteriaceae (CPE) and non-carbapenemase-producing carbapenem nonsusceptible Enterobacteriaceae (NCPCRE). We sought to investigate the effect of antecedent carbapenem exposure as a risk factor for NCPCRE versus CPE. Among all patients with CRE colonization and infection, we conducted a case-control study comparing patients with NCPCRE (cases) and patients with CPE (controls). The presence of carbapenemases was investigated with phenotypic tests followed by PCR for predominant carbapenemase genes. We included 843 unique patients with first-episode CRE, including 387 (45.9%) NCPCRE and 456 (54.1%) CPE. The resistance genes detected in CPEs were blaNDM (42.8%), blaKPC (38.4%), and blaOXA-48-like (12.1%). After adjusting for confounders and clustering at the institutional level, the odds of prior 30-day carbapenem exposure was three times higher among NCPCRE than CPE patients (adjusted odds ratio [aOR], 3.48; 95% confidence interval [CI], 2.39 to 5.09; P < 0.001). The odds of prior carbapenem exposure and NCPCRE detection persisted in stratified analyses by Enterobacteriaceae species (Klebsiella pneumoniae and Escherichia coli) and carbapenemase gene (blaNDM and blaKPC). CPE was associated with male gender (aOR, 1.45; 95% CI, 1.07 to 1.97; P = 0.02), intensive care unit stay (aOR, 1.84; 95% CI, 1.24 to 2.74; P = 0.003), and hospitalization in the preceding 1 year (aOR, 1.42; 95% CI, 1.01 to 2.02; P = 0.05). In a large nationwide study, antecedent carbapenem exposure was a significant risk factor for NCPCRE versus CPE, suggesting a differential effect of antibiotic selection pressure.
Subject(s)
Anti-Bacterial Agents/adverse effects , Bacterial Proteins/metabolism , Carbapenems/adverse effects , Enterobacteriaceae/drug effects , beta-Lactamases/metabolism , Carbapenem-Resistant Enterobacteriaceae/drug effects , Carbapenem-Resistant Enterobacteriaceae/metabolism , Case-Control Studies , Enterobacteriaceae/metabolism , Enterobacteriaceae Infections/drug therapy , Escherichia coli/drug effects , Female , Humans , Klebsiella pneumoniae/drug effects , Male , Microbial Sensitivity Tests/methods , Risk FactorsABSTRACT
PURPOSE: To evaluate the efficacy and safety of a submicron formulation of loteprednol etabonate (LE) gel 0.38% instilled three times daily (TID) compared with vehicle for the treatment of inflammation and pain following cataract surgery with intraocular lens implantation, integrated across two multicenter, double-masked, randomized, parallel-group, Phase III studies. PATIENTS AND METHODS: Subjects ≥18 years of age with anterior chamber (AC) cells ≥grade 2 (6-15 cells) on day 1 after cataract surgery were randomized to receive 1 drop of LE gel 0.38% TID, twice daily (not reported/analyzed herein), or vehicle instilled in the study eye for 14 days. Primary endpoints were the proportion of subjects with resolution of AC cells and grade 0 (no) pain at postoperative day 8. Safety outcomes included adverse events (AEs), ocular signs, fundoscopy results, visual acuity, intraocular pressure (IOP), and tolerability (drop comfort and ocular symptoms). RESULTS: The integrated intent-to-treat population included 742 subjects (LE gel 0.38% TID, n=371; vehicle, n=371). Significantly more subjects in the LE gel 0.38% TID group compared with the vehicle group had complete resolution of AC cells (29.6% vs 15.1%) and grade 0 pain (74.4% vs 48.8%) at day 8 (P<0.0001 for both). LE gel 0.38% TID was safe and well tolerated, with only 1 LE-treated subject experiencing an IOP elevation ≥10 mm Hg. Most treatment-related AEs were mild and occurred less frequently with LE gel 0.38% than with vehicle. The majority (>75%) of subjects in each treatment group reported no drop discomfort. There were no reports of blurred vision with LE gel. CONCLUSION: The results of this integrated analysis indicate that LE (submicron) gel 0.38% administered TID is safe and effective for the treatment of ocular inflammation and pain following cataract surgery, with minimal risk of IOP elevation.
ABSTRACT
Dysphagia is a common sequela post chemo/radiotherapy for nasopharyngeal carcinoma (NPC), with cricopharyngeal dysfunction often a contributing factor. This study examined the impact of balloon dilation of the cricopharyngeus and cervical oesophagus on swallow competence for dysphagic patients with cricopharyngeal dysfunction post NPC. Patients with NPC were screened for dysphagia and cricopharyngeal dysfunction using fiberoptic endoscopic evaluation. Thirteen symptomatic patients, median 14.1 years post chemoradiotherapy for NPC, then underwent balloon dilation under local anesthesia. Before and 1 month post dilation, swallow function was assessed with fluoroscopy, and rated using the penetration-aspiration scale, temporal swallowing measures, and MBSImP pharyngoesophageal segment opening and esophageal clearance parameter. The MD Anderson Dysphagia Inventory (MDADI; Chinese version) and the Functional Oral Intake Scale (FOIS) were collected pre-, 1 month, and approximately 3 months post dilation. Post-dilation, significant improvements were noted in mean FOIS scores (5.00 to 5.62), duration of cricopharyngeus opening (0.42 s to 0.53 s), MBSImP pharyngoesophageal opening scores (1.61 to 1.08), penetration-aspiration scale scores (4.85 to 3.92) and MDADI Composite score (46.48 to 52.43). At 3 months post dilation, the MDADI Composite Score showed sustained benefit. The procedure was well tolerated and without complication. In patients with cricopharyngeal dysfunction post NPC, balloon dilation significantly improved swallow function, reduced aspiration risk and improved quality of life. Evidence from a larger cohort with long-term follow-up is warranted to determine sustained benefit.
Subject(s)
Deglutition Disorders/therapy , Dilatation/methods , Nasopharyngeal Carcinoma/therapy , Nasopharyngeal Neoplasms/therapy , Adult , Aged , Chemoradiotherapy/adverse effects , Deglutition , Deglutition Disorders/etiology , Dilatation/instrumentation , Female , Humans , Male , Middle Aged , Pilot Projects , Young AdultABSTRACT
ABSTRACTMedical issues facing the aging population are of growing concern with consequences for patients and their caregivers. This study determined the indirect and out-of-pocket costs incurred by the caregivers of elderly patients in Canadian Intensive Care Units (ICUs). Primary family caregivers were surveyed capturing out-of-pocket costs, hours of work, and hours of leisure forgone in providing patient care while the patient was in the ICU. Total costs of care per month were reported across caregiver sex, age, and geographic region. Average out-of-pocket costs were $791 (2016 Canadian dollars) in the first month of ICU care. The mean total cost to family caregivers per patient was $162 per day. Male primary caregivers had higher mean out-of-pocket costs than female caregivers. Subsidization programs covering expenses such as travel, meals, accommodation, and parking are needed to support family caregivers of elderly ICU patients who are incurring considerable out-of-pocket costs.
Subject(s)
Caregivers/economics , Health Expenditures/statistics & numerical data , Intensive Care Units/economics , Aged , Aged, 80 and over , Canada , Female , Humans , Male , Middle AgedABSTRACT
PURPOSE: To assess the safety and efficacy of a 0.38% submicron formulation of loteprednol etabonate (LE) gel for the treatment of postoperative inflammation and pain after cataract surgery. SETTING: Forty-five United States ophthalmology practices. DESIGN: Double-masked vehicle-controlled randomized parallel group study. METHODS: Patients 18 years of age or older with anterior chamber cells grade 2 or higher on day 1 after uncomplicated cataract surgery were randomized to 14 days of treatment with LE gel 2 times a day, LE gel 3 times a day, or vehicle. Hierarchical primary endpoints were the proportion of patients with resolution of anterior chamber cells and grade 0 (no) pain at postoperative day 8. Safety outcomes included adverse events, intraocular pressure (IOP), biomicroscopy, visual acuity, ophthalmoscopy, and tolerability (drop comfort and ocular symptoms). RESULTS: The intent-to-treat population included 514 patients. Significantly more patients in the LE gel 2 times a day and 3 times a day groups compared with the vehicle group had complete resolution of anterior chamber cells (26.9% and 28.7% versus 9.3%) and reported grade 0 pain (73.7% and 73.1% versus 47.7%) on day 8 (P < .001 vs vehicle for all). The safety findings were unremarkable, with 1 patient experiencing an IOP increase of 10 mm Hg or higher while on LE gel. More than 75% of patients in each group reported no drop discomfort. CONCLUSION: In this study, submicron loteprednol etabonate gel 0.38% appeared safe and effective in the treatment of postoperative inflammation and pain whether instilled 2 times or 3 times a day.
Subject(s)
Anti-Allergic Agents/therapeutic use , Eye Pain/drug therapy , Inflammation/drug therapy , Loteprednol Etabonate/therapeutic use , Phacoemulsification/adverse effects , Postoperative Complications , Adult , Aged , Aged, 80 and over , Anti-Allergic Agents/adverse effects , Double-Blind Method , Eye Pain/etiology , Female , Gels , Humans , Inflammation/etiology , Intraocular Pressure , Loteprednol Etabonate/adverse effects , Male , Microscopy, Acoustic , Middle Aged , Ophthalmoscopy , Treatment Outcome , Visual Acuity/physiologyABSTRACT
A 50-year-old immunocompetent man presented with intracranial space-occupying lesions and a right lung mass. This was found to be disseminated Cryptococcus gattii infection. Following 15 months of anti-fungal therapy, imaging showed reduction in the size of the pulmonary cryptococcoma and new multi-lobar ground-glass opacities interspersed with a crazy-paving pattern. Surgical lung biopsy was performed after bronchoscopic evaluation was non-yielding. Histology showed intra-alveolar accumulation of foamy macrophages and airspaces containing periodic acid Schiff-positive amorphous eosinophilic material with strong immune positivity for surfactant A, consistent with a diagnosis of pulmonary alveolar proteinosis (PAP). The majority of adult-onset PAP is due to the presence of anti-granulocyte macrophage colony-stimulating factor antibodies. Opportunistic fungal and mycobacterial infections are known to occur in these patients due to alveolar macrophage and neutrophilic dysfunction. The onset of PAP may occur concurrently with, or be temporally distinct from, opportunistic infections. For patients with respiratory failure, whole lung lavage is a therapeutic strategy.