scholarly journals In-Office Tympanostomy Tube Placement Using Iontophoresis and Automated Tube Delivery Systems

OTO Open ◽  
2020 ◽  
Vol 4 (1) ◽  
pp. 2473974X2090312 ◽  
Author(s):  
David M. Yen ◽  
Michael T. Murray ◽  
Robert Puchalski ◽  
Andrew R. Gould ◽  
John Ansley ◽  
...  
Keyword(s):  
Tympanic Membrane ◽  
Pain Score ◽  
Delivery System ◽  
The United States ◽  
New Drugs ◽  
Tube Placement ◽  
Tympanostomy Tube ◽  
Technical Success ◽  
Performance Goal ◽  
Patient Reported

Objectives (1) To evaluate safety, tolerability, and technical success of lidocaine iontophoresis and a tympanostomy tube placement system for adults in an office setting and (2) to meet regulatory evidence requirements for new drugs and devices. Study Design Prospective, multicenter, single arm. Setting Patients were recruited in 8 community-based practices in the United States between June and September 2017. Subjects and Methods This study evaluated tympanic membrane anesthesia and tube placement in 30 adults. Anesthesia was achieved via iontophoresis of a lidocaine/epinephrine solution. Tube placement was conducted using an integrated myringotomy and tube delivery system. Tolerability of tube placement was measured using a patient-reported visual analog scale from 0 mm ( no pain) to 100 mm ( worst possible pain). Mean pain score was compared to a performance goal of 45 mm, where statistical superiority represents mild pain or less. Technical success and safety through 3 weeks postprocedure were evaluated. Results Twenty-nine (29/30, 96.7%) patients had tube(s) successfully placed in all indicated ears. One patient demonstrated inadequate tympanic membrane anesthesia, and no tube placement was attempted. The mean (SD) pain score of 9.4 (15.7) mm was statistically superior to the performance goal. There were no serious adverse events. Seven nonserious events were related to device, procedure, or drug: inadequate anesthesia (1), vertigo (1), and dizziness (1) at the time of procedure and ear discomfort (1), tube occlusion (2), and medial tube migration (1) postprocedure. Conclusion Lidocaine iontophoresis provides acceptable tympanic membrane anesthesia for safe, tolerable, and successful in-office tube placement using an integrated myringotomy and tube delivery system.

scholarly journals Shape-Memory Nitinol Tympanostomy Tube and All-in-One Introducer Device for Treatment of Otitis Media

2010 ◽  
Vol 4 (2) ◽  
Author(s):  
Michael Loushin ◽  
Keith Leland
Keyword(s):  
Shape Memory ◽  
Otitis Media ◽  
Point Of Care ◽  
The United States ◽  
Tube Placement ◽  
Tympanostomy Tube ◽  
Office Visits ◽  
Antibiotic Resistant ◽  
Bacterial Organism ◽  
Disposable Device

Otitis media is the most common bacterial illness in children, resulting in millions of office visits, antibiotic prescriptions, and surgical procedures annually in the United States. Antibiotics are commonly prescribed and has resulted in increased prevalence of antibiotic resistant strains of organisms. Additionally, patients with otitis media are candidates for tympanocentesis, myringotomy, and tympanostomy tube placement procedures. The ability to safely and efficiently perform these procedures to accurately diagnose, identify the bacterial organism, and treat otitis media with point of care therapy is needed. A shape-memory nitinol tympanostomy tube and an all-in-one introducer device (OtoStent tympanostomy device) currently under development will allow clinicians to safely and efficiently perform myringotomy, tympanocentesis, and tympanostomy tube placement with a single disposable device.

scholarly journals Tympanostomy Tube Selection: A Review of the Evidence

2016 ◽  
Vol 7 (1) ◽  
pp. 17-22
Author(s):  
Ho Sandra ◽  
David J Kay
Keyword(s):  
Otitis Media ◽  
Middle Ear ◽  
Otitis Media With Effusion ◽  
Acute Otitis Media ◽  
The United States ◽  
Tube Placement ◽  
Tympanostomy Tube ◽  
Middle Ear Effusion ◽  
Surgeon Experience ◽  
Ear Effusion

ABSTRACT Tympanostomy tube (TT) insertion for ventilation of the middle ear is one of most commonly performed procedures in the United States. Indications for tube insertion include otitis media with effusion, recurrent acute otitis media, hearing loss caused by middle ear effusion and persistent acute otitis media. In general, TTs are divided into two categories, short-term tubes and long-term tubes. Depending on the indications for tube placement and surgeon experience with the TT, different tubes can be used. A myriad of tubes have been created since their first documented use in 1845 in attempts to provide better middle ear ventilation, improve ease of placement and prevent complications, such as post-tube otorrhea, persistent perforation and tube occlusion. In order for a tube to be effective, it should be biocompatible with the middle ear to minimize a foreign body reaction. Teflon and silicone remain two of the most commonly used materials in TTs. In addition, the tube design also plays a role for insertion and retention times of TTs. Lastly, TTs can also be coated with various substances, such as silver-oxide, phosphorylcholine and more recently, antibiotics and albumin, in order to prevent biofilm formation and decrease the rate of post-TT otorrhea. Persistent middle ear effusion affects many children each year and can impact their quality of life as well as hearing and language development. With nearly 1 out of every 15 children by the age of 3 years receiving TTs, it is imperative that the right tube be chosen to facilitate optimal ventilation of the middle ear while minimizing complications. How to cite this article Ho S, Kay DJ. Tympanostomy Tube Selection: A Review of the Evidence. Int J Head Neck Surg 2016;7(1):17-22.

scholarly journals Behavioral Strategies to Minimize Procedural Distress During In-Office Pediatric Tympanostomy Tube Placement Without Sedation or Restraint

2021 ◽  
Author(s):  
Lindsey L. Cohen ◽  
Abigail S. Robbertz ◽  
Laura J. England
Keyword(s):  
Delivery System ◽  
Race And Ethnicity ◽  
Rating Scale ◽  
Pain Scale ◽  
Outpatient Setting ◽  
Tube Placement ◽  
Tympanostomy Tube ◽  
Behavioral Strategies ◽  
Older Children ◽  
Behavioral Program

AbstractThe purpose of this study was to evaluate behavioral strategies to minimize procedural distress associated with in-office tympanostomy tube placement for children without general anesthesia, sedation, or papoose-board restraints. 120 6-month- to 4-year-olds and 102 5- to 12-year-olds were treated at 16 otolaryngology practices. Mean age of children was 4.7 years old (SD = 3.18 years), with more boys (58.1%) than girls (41.9%). The cohort included 14% Hispanic or Latinx, 84.2% White, 12.6% Black, 1.8% Asian and 4.1% ‘Other’ race and ethnicity classifications. The in-office tube placement procedure included local anesthesia via lidocaine/epinephrine iontophoresis and tube placement using an integrated and automated myringotomy and tube delivery system. Behavioral strategies were used to minimize procedural distress. Anxiolytics, sedation, or papoose board were not used. Pain was measured via the faces pain scale-revised (FPS-R) self-reported by the children ages 5 through 12 years. Independent coders supervised by a psychologist completed the face, legs, activity, cry, consolability (FLACC) behavior observational rating scale to quantify children’s distress. Mean FPS-R score for tube placement was 3.30, in the “mild’ pain range, and decreased to 1.69 at 5-min post-procedure. Mean tube placement FLACC score was 4.0 (out of a maximum score of 10) for children ages 6 months to 4 years and was 0.4 for children age 5–12 years. Mean FLACC score 3-min post-tube placement was 1.3 for children ages 6 months to 4 years and was 0.2 for children age 5–12 years. FLACC scores were inversely correlated with age, with older children displaying lower distress. The iontophoresis, tube delivery system and behavioral program were associated with generally low behavioral distress. These data suggest that pediatric tympanostomy and tube placement can be achieved in the outpatient setting without anxiolytics, sedatives, or mechanical restraints.

scholarly journals Patient-Reported Outcome Labeling for Malignant Hematology Drugs Approved in the United States: 2011-2017

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2292-2292
Author(s):  
Marjorie E Zettler ◽  
Ethan Basch ◽  
Chadi Nabhan
Keyword(s):  
Drug Approval ◽  
The United States ◽  
Patient Reported Outcome ◽  
Health Condition ◽  
New Drugs ◽  
Approval Process ◽  
New Drug ◽  
Study Results ◽  
Patient Reported ◽  
Drug Approval Process

Abstract Introduction: Patient-reported outcomes (PROs), defined as any report on the status of a patient's health condition that comes directly from the patient without interpretation by anyone else, play an increasingly important role in drug development. In 2009 the FDA issued final guidance on using PRO measures to support labeling claims, to incorporate the patient perspective into the drug approval process. The 21st Century Cures Act emphasizes PROs as a differentiating element in the FDA approval process of new drugs, beyond traditional clinical outcome measures. Further, recent data has shown that intervention based on PROs can improve survival in metastatic cancers (Basch et al; 2017). The incorporation of PROs into the labeling of new drugs for malignant hematology disorders has not been studied and is the subject of this investigation. Methods: We reviewed the FDA's Novel New Drug Summaries (2011-2017) to identify drugs approved for malignant hematology indications. Drug approval packages and product labeling were accessed via the Drugs@FDA database and analyzed for PRO endpoints, measures, and labeling claims. Clinical trial designs and published study results were retrieved via the ClinicalTrials.gov website and PubMed. Results: Of 250 novel drugs approved by the FDA between 2011 and 2017, 22 (8.8%) were approved for malignant hematology indications. Interestingly, only 1 had PRO-based claims in their labeling, even though 13 of the 22 drugs (59%) collected PRO data in pivotal trials that led to their approval. Notably, the proportion of malignant hematology trials assessing PROs has increased over time, with 4 of the 5 drugs approved in 2017 for malignant hematology indications evaluating PROs in their development programs, compared with 9 of the 17 drugs approved in the preceding 6 years (80% vs. 53%). PROs evaluated included generic instruments such as the EQ-5D, and disease-specific instruments such as the EORTC QLQ-C30 (see table). Reasons cited for rejection of PRO data inclusion in drug labeling were single arm trial design, excessive missing data, statistical issues, and use of an inappropriate PRO instrument. Conclusions: While the FDA encourages PRO data submission as part of the new drug approval process, and although more than half of all malignant hematology drugs approved in the past 7 years assessed PROs during development, only 1 was able to successfully acquire labeling claims. Whether this is due to lack of PRO expertise on clinical development teams or absence of strong regulatory guidance on how best to implement PROs remains unknown and requires further research. Designing strategies to develop, validate and report PROs effectively is needed to meet regulatory requirements and enhance patients' voices in their own care. Table. Table. Disclosures Nabhan: Cardinal Health: Employment, Equity Ownership.

Epidemiology of Pediatric Tympanostomy Tube Placement in the United States

2020 ◽  
Vol 163 (3) ◽  
pp. 600-602
Author(s):  
Neil Bhattacharyya ◽  
Sophie G. Shay
Keyword(s):  
United States ◽  
Clinical Practice ◽  
Practice Guidelines ◽  
National Health Interview Survey ◽  
The United States ◽  
Tube Placement ◽  
Tympanostomy Tube ◽  
The Past ◽  
Interview Survey ◽  
Ear Infections

The prevalence of pediatric tympanostomy tube placement (TTP) in the United States has not been reassessed in the past decade. To assess the prevalence of TTP and frequent ear infections (FEI), the National Health Interview Survey for the calendar year 2014 was used. Among 73.1 million children, 6.26 million (8.6%) had TTP. The incidence of FEI was 3.49 million (4.8%). Males (9.6%) were more likely than females (7.5%) to undergo TTP ( P = .004). Among children under 2 years of age, 9.1% reported FEI, compared to 3.9% of children aged 3 to 17 years. Among children under 2 years of age, 25% with FEI received TTP vs 1.5% without FEI ( P < .001). Among children aged 3 to 17 years, 31.1% with FEI received TTP vs 8.6% without FEI ( P < .001). TTP may be increasing nationally, although further assessment of adherence to clinical practice guidelines is needed to investigate this potential trend.

scholarly journals A Comparison of Outcomes following Tympanostomy Tube Placement or Conservative measures for Management of Otitis Media with Effusion

2007 ◽  
Vol 86 (9) ◽  
pp. 552-554 ◽  
Author(s):  
Svetlana Diacova ◽  
Thomas J. McDonald
Keyword(s):  
Conservative Treatment ◽  
Tympanic Membrane ◽  
Otitis Media ◽  
Otitis Media With Effusion ◽  
Tube Placement ◽  
Lower Percentage ◽  
Tympanostomy Tube ◽  
Tympanic Membrane Perforations ◽  
Significant Difference ◽  
Retraction Pockets

We obtained the charts of 183 patients (197 ears) who had undergone surgery for chronic otitis media (COM), and we reviewed their otic histories to analyze the series of events that ultimately culminated in surgery. All ears had originally been treated for otitis media with effusion (OME); 125 ears had been treated with tympanostomy tube placement, and 72 ears had been treated with conservative measures. Our goal was to compare the influence that these two strategies had on the subsequent development of COM and its sequelae (i.e., retraction pockets, tympanic membrane perforations, and cholesteatomas) and thereby determine which strategy is preferable. We found that although retraction pockets developed in a significantly higher proportion of the tympanostomy-treated ears than the conservatively treated ears (58 vs. 35%; p < 0.01), a significantly greater percentage of retractions in the tympanostomy-treated ears were mild and situated in the anterior part of the tympanic membrane (52 vs. 32%; p < 0.05). Moreover, severe retractions were significantly more common in the conservatively treated ears (40 vs. 16%; p < 0.02); the incidence of complete retractions in the two groups of ears was similar (tympanostomy: 32%; conservative treatment: 28%). Cholesteatomas developed in a significantly lower percentage of tympanostomy-treated ears (67 vs. 81%; p < 0.05), and the incidence of large cholesteatomas that involved the tympanic and mastoid cavities was likewise significantly lower in these ears (44 vs. 69%; p < 0.05). There was no significant difference in the incidence of tympanic membrane perforations. Finally, even though all of these ears eventually required surgery for COM, the tympanostomy-treated ears required significantly fewer repeat surgeries (16 vs. 28%; p < 0.05) and significantly fewer radical modified tympanomastoidectomies (30 vs. 44%; p < 0.05). Therefore, we conclude that myringotomy with insertion of tympanostomy tubes to treat OME is superior to conservative treatment.

Clinical Characteristics of Patients Diagnosed with Strongyloidiasis in a United States Urban Outpatient Dermatology Department: A Case Series

2017 ◽  
Vol 1 (3) ◽  
pp. 156-160
Author(s):  
Jacqueline Watchmaker ◽  
Sean Legler ◽  
Dianne De Leon ◽  
Vanessa Pascoe ◽  
Robert Stavert
Keyword(s):  
United States ◽  
Case Series ◽  
The United States ◽  
Screening Tools ◽  
Dermatology Department ◽  
Cutaneous Manifestations ◽  
Serologic Testing ◽  
Patient Reported ◽  
History Of ◽  
Endemic Areas

Background: Although considered a tropical disease, strongyloidiasis may be encountered in non-endemic regions, primarily amongst immigrants and travelers from endemic areas.  Chronic strongyloides infection may be under-detected owing to its non-specific cutaneous presentation and the low sensitivity of commonly used screening tools. Methods: 18 consecutive patients with serologic evidence of strongyloides infestation who presented to a single urban, academic dermatology clinic between September 2013 and October 2016 were retrospectively included.  Patient age, sex, country of origin, strongyloides serology titer, absolute eosinophil count, presenting cutaneous manifestations, and patient reported subjective outcome of pruritus after treatment were obtained via chart review.  Results: Of the 18 patients, all had non-specific pruritic dermatoses, 36% had documented eosinophila and none were originally from the United States. A majority reported subjective improvement in their symptoms after treatment. Conclusion:  Strongyloides infection and serologic testing should be considered in patients living in non-endemic regions presenting with pruritic dermatoses and with a history of exposure to an endemic area.Key Points:Chronic strongyloidiasis can be encountered in non-endemic areas and clinical manifestations are variableEosinophilia was not a reliable indicator of chronic infection in this case series Dermatologists should consider serologic testing for strongyloidiasis in patients with a history of exposure and unexplained pruritus

New Drugs of 2012: A Concise Overview of the NMEs and Trends for Innovative Brand Market in the United States

2013 ◽  
Vol 6 (2) ◽  
pp. 2009-2013
Author(s):  
D Samba Reddy
Keyword(s):  
Drug Approval ◽  
The United States ◽  
New Drugs ◽  
New Combination ◽  
Drug Status ◽  
Combination Drug ◽  
Human Cord Blood ◽  
Life Saving ◽  
Genomics And Proteomics ◽  
The Face

Thirty-nine (39) new drugs have been approved by the U.S. FDA in 2012, a record highest number of approvals since 1996. The record is a sign that pharma companies are poised to tap recent advances from genomics and proteomics. This list includes novel new drugs, known as new molecular entities (NMEs), biologics and new products. Many life-saving drugs are approved for marketing. The list includes a total of 10 drugs for cancer treatment, and nearly a quarter of those approved in 2012 had orphan drug status.  Among the breakthrough drugs approved in 2012 were ivacaftor (cystic fibrosis), vasmodegib (skin cancer), HPC-C (human cord blood product), ruxolitinib (myelofibrosis) and a new combination drug to treat HIV. In addition,  several unique products were approved for the treatment of macular degeneration, chronic weight management, overactive bladder, actinic keratosis, erectile dysfunction, glaucoma, respiratory distress syndrome, and COPD. The approval of 39 drugs in 2012 underscores a robust success rate and confirms that innovation is once again beginning to pay off. In the existing climate of reduced revenues in the face of generic competitions, the future and survival of big companies rests heavily on their unique niche products. It is apparent that big Pharma and a growing number of emerging Biotechs alike have focused their attention on developing new NMEs for rare diseases. In 2012, the length of the FDA’s review is shorter than agencies in other countries. Innovative models adopted for R&D strategies, communications, and new regulatory changes appear to shorten development timelines. Despite record drug approvals, there is bleak scope for blockbusters because most of these drugs have a limited market. The pipeline for blockbusters appears very low. However, there is unmet medical need for new drugs in autism, Alzheimer’s disease and epilepsy. Overall, the new drug approval list unveils unique and reemerging trends indicating that the pharma companies are poised for big growth from new brands approved for marketing for narrow-spectrum indications.    

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