Use of rhDNase Therapy and Costs of Respiratory-Related Care in Patients with Cystic Fibrosis

2000 ◽  
Vol 34 (3) ◽  
pp. 304-308 ◽  
Author(s):  
Daniel A Ollendorf ◽  
Lisa J McGarry ◽  
Marc L Watrous ◽  
Gerry Oster

OBJECTIVE: To assess the relationship between level of use of recombinant deoxyribonuclease I (rhDNase) therapy and costs of respiratory-related care in patients with cystic fibrosis. DESIGN: Retrospective, cohort study using healthcare claims data from a large New England health insurer. PATIENTS: All cystic fibrosis patients five years of age and older who began therapy with rhDNase in 1994 (the year it was first marketed in the US). Healthcare claims were compiled for six months prior to first receipt of rhDNase (pretreatment) and for 30 months subsequently (follow-up). Patients were stratified according to their level of rhDNase use during follow-up, based on whether it was above or below the median number of therapy days for the sample. MAIN OUTCOME MEASURES: Costs of rhDNase, all antibiotics, and all respiratory-related outpatient (physician, home health, hospital outpatient) and inpatient care were included. All costs were expressed on an annualized basis. RESULTS: Twenty-four patients with cystic fibrosis who began treatment with rhDNase in 1994 met all entry criteria; the median number of therapy days over a 30-month period was 355. Among patients with low (i.e., below the median) rhDNase use (n = 12), mean ± SD annualized costs of respiratory-related care increased by almost $17000 between pretreatment and follow-up, from $29251 ± $37919 to $46109 ± $40944. Among high-use patients (n = 12), costs decreased by approximately $2500, from $37178 ± $48476 to $34592 ± $22591. The change in both groups was accounted for primarily by a change in the number of respiratory-related hospitalizations. CONCLUSIONS: Prolonged use of rhDNase may reduce costs of respiratory-related care in patients with cystic fibrosis; further study is required, however, to confirm these findings.

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S682-S682
Author(s):  
Liping Huang ◽  
Jennifer L Nguyen ◽  
Johnna Perdrizet ◽  
Tamuno Alfred ◽  
Adriano Arguedas

Abstract Background Coronavirus Disease 2019 (COVID) mitigation measures may have unintended consequences, such as reduced or delayed access to routine immunizations. This study examined (1) PCV13 routine vaccination completion and adherence (C&A) among US infants before and during the COVID pandemic and (2) the relationship between primary dose C&A and booster dose C&A. Methods Retrospective data from the Optum’s de-identified Clinformatics Data Mart Database were used to create 3 cohorts: C1, Pre-COVID; C2, During COVID; C3, Cross-COVID (Figure 1). The completion was defined as number of PCV13 doses received within 8 months of birth, and the adherence was defined number of doses received at ACIP recommended time (@2, 4, 6 months, +/- 5 days). Univariable logistic regression was used to compare the odds of primary dose C&A in cohorts C1 and C3 vs C2 and descriptive analyses were used to explore primary dose C&A in relation to booster dose C&A. Figure 1: Study population and inclusion criteria Results A total of 172,916, 70,049, and 34,854 infants were included in C1, C2, and C3. Among infants with > 8 months of follow-up from birth (N=132,183 for C1&C3, 16,522 for C3), 3-primary dose completion was statistically significantly higher before COVID than during COVID (crude OR = 1.10, 95% CI: 1.06-1.15). The 3-primary dose adherence was also higher before COVID than during COVID (crude OR = 1.10, 95% CI: 1.05-1.15). Among infants with ≥2, 4 and 6 months of follow-up, adherence of each individual dose was consistently higher before COVID than during COVID (1st dose: OR = 1.03, 95% CI: 1.01–1.04; 2nd dose: OR = 1.04, 95% CI: 1.01 – 1.06; 3rd dose: OR = 1.12, 95% CI: 1.08 – 1.15) (Table 1). Booster dose completion was higher in infants who completed or adhered to 3 primary doses than infants who completed or adhered to only 1 or 2 primary doses (Figure 2, Overall) and booster dose C&A was generally higher before COVID than during COVID (Figure 2, Cohort 1 vs. Cohort 3). Table 1. Comparison of completion and adherence of primary dosing series per-COVID vs. during-COVID era Figure 2: Booster dose completion and adherence in relation to primary dosing completion (A) and adherence (B) Conclusion These results indicated that PCV13 full completion was statistically lower during COVID, but the magnitude of the difference in infants was not extensive. Infants who completed or adhered to all three primary doses were more likely to complete or adhere to the booster dose. Further research is warranted as structured datasets mature to capture the full time span of COVID-19 mitigation measures. Disclosures Liping Huang, MD, MA, MS, Pfizer Inc (Employee) Jennifer L Nguyen, ScD, MPH, Pfizer Inc. (Employee) Johnna Perdrizet, MPH, Pfizer Inc (Employee) Tamuno Alfred, PhD, Pfizer Inc. (Employee) Adriano Arguedas, MD, Pfizer (Employee)


Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3519-3519 ◽  
Author(s):  
Ashraf Badros ◽  
T. Evangelos ◽  
O. Goloubeva ◽  
T. Meiller ◽  
E. Kastritis ◽  
...  

Abstract Risk factors for ONJ in MM pts include dental extraction, bisphosphonates (BP) use, older age and longer survival. There is also an increased risk of skeletal related events (SRE) in ONJ pts (Badros, JCO 2006). The current study provides long term follow-up data for ONJ pts with regard to ONJ recurrence, SRE and MM status. The study included 97 pts: 60 from Greece and 37 from the US. Pts’ characteristics are summarized in the table below. Median follow-up time has not been reached; lower limit of the 95%CI was 3.2 yrs. ONJ resolved in 60 of 97 pts (62%), resolved and recurred in 12 pts (12%), and did not heal over a 9 months period in 25 pts (26%). Dental extraction preceded ONJ in 46 of 97 pts (47%) and was more common in pts with a single episode of ONJ (35 of 60, 58%) than in the recurrent and non-healing pts (11 of 37, 30%) (p-value=0.007). The median number of ONJ episodes in the recurrent group was 3 (range, 2–6); recurrence of ONJ was precipitated by re-initiation of BP and by dental procedures in 5 and 4 pts of 12, respectively. There was a trend toward higher ONJ recurrence rate in the US (8 of 37, 22%) versus the Greek (4 out of 60, 7%) pts (p-value=0.053). Surgery was performed more often in the US than in Greece 17 of 37 (45%) versus 19 of 60 pts (32%). BP reinitiation was more frequent in US 16 of 37 (43%) than in Greece 3 of 60 (5%). Non-healing ONJ lesions were managed with antibiotics; 10 of 25 pts developed fistulas and needed surgery; in 9 pts the lesions remained asymptomatic. Twenty-one ONJ pts had SRE including fractures (ribs, vertebrae and long bones, n=13) and avascular necrosis of the femur (n=8). The rate of MM relapse was higher in pts with recurrent and non-healing ONJ (84%) compared to pts with a single episode (62%) (p-value=0.02). The median OS from diagnosis of MM was 10.8 yrs (95% CI; 9.3 yrs- not reached) and did not differ between pts with single, recurrent/non-healing ONJ (p= 0.2). In summary, pts in whom ONJ followed dental procedures were less likely to have recurrence or non-healing, both, although infrequent, were linked to BP re-challenge, mostly in the setting of relapsed MM. Non-healing ONJ lesions remained stable/asymptomatic without extensive intervention. BP should be discontinuation until ONJ lesions heal. The decision to restart BP should be individualized based on MM-SRE risk. ONJ Pts characteristics and outcome AA, African American; ttt, treatment; CR, complete remission; PR, partial remission; PD, progressive disease; Dex, dexamethasone, thal, thalidomide; Len, lenalidomide; Bort, bortezomib; A, pamidronate; Z zoledronic acid. The Fisher’s Exact test was used, all p-values reported are two-sided. ONJ, n= 97 one episode, n=60 recurrent, n=12 non-healing, n=25 age at MM; median (range) 60 (26–77) 61 (26–77) 55 (43–76) 61 (36–73) Sex; male/female 59/38 38/22 8/4 13/12 Caucasian/AA 87/10 54/6 10/2 23/2 Isotype; IgG, A, D, LCH 60/20/1/16 36/11/1/12 7/2/0/3 17/7/0/1 MM ttt at ONJ (n=93); none/dex/thal/len/bort 22/31/26/6/8 11/25/16/4/2 5/1/3/1/1 6/5/7/1/4 MM status at ONJ diagnosis; CR/PR/PD 7/54/33 4/37/17 3/8/1 0/9/15 BP use; AZ/Z 59/35 34/23 10/2 15/10 Dental extraction 46 35 5 5 Restarted BP 19 11 6 2 bone complciations 21 14 3 4 MM course after ONJ; continous remission/Relapse 29/68 23/37 2/10 4/21 MM status at last follow up; CR/PR/PD (died) 3/59/35(28) 3/35/22(20) 0/10/2(2) 0/14/11(6)


2021 ◽  
Vol 162 (14) ◽  
pp. 530-541
Author(s):  
Péter Palásti ◽  
Tamás Zombori ◽  
László Kaiser ◽  
Sándor Magony ◽  
Flóra Kakuja ◽  
...  

Összefoglaló. A pajzsmirigy az első szervek közé tartozik, melyek megjelenítésében, betegségeinek felfedezésében az ultrahang-diagnosztikának fontos szerepe van. A pajzsmirigybetegségek a lakosság jelentős részét érintik, és a technika fejlődésével egyre több pajzsmirigyeltérés, göb kerül felfedezésre. A pajzsmirigy rosszindulatú folyamatainak nincs egy bizonyos specifikus jele, viszont az ultrahangkép alapján meghatározhatók a malignitásra gyanús eltérések. Erre az elmúlt években több összefoglaló rendszer is született. Jelen összefoglaló tanulmányunknak az a célja, hogy bemutassuk a pajzsmirigy ultrahangdiagnosztikájának fejlődését; összehasonlítsuk az egyes leletezési rendszereket, úgymint TIRADS, EU-TIRADS, K-TIRADS, melyek célja a feltehetőleg rosszindulatú göbök kiszűrése, azonosítása a mindennapi rutinmunka során; vizsgáljuk a különböző rendszerek kapcsolatát a patológia által használt Bethesda-pontrendszerrel. Az ultrahangvizsgálat megfelelő értékelése, a pontrendszerek ismerete segíthet a pajzsmirigygöb differenciáldiagnózisában, a követési frekvencia meghatározásában, csökkentheti az aspirációs citológiák számát, ezzel támogatva a klinikai döntéshozatalt. Orv Hetil. 2021; 162(14): 530–541. Summary. The thyroid gland was one of the first organs, the ultrasound (US) examination of which has played an important role. The thyroid diseases affect a large part of the population, and with the development of imaging technology, more and more thyroid abnormalities, nodules and malignant lesions are being discovered. There are no specific signs of thyroid cancer, but the suspicious signs could be determined by US. In recent years, several systems have been developed. The aim of our review is to demonstrate the development of US diagnostics of the thyroid gland; to compare the different reporting systems, such as TIRADS, EU-TIRADS, K-TIRADS, which should help to identify the questionable lesions in the daily routine work. We examine the relationship between the different US systems and the Bethesda point score used by pathologists. The literature review shows that the US examination supports the clinical decisions, helps to select, who should have a fine-needle biopsy, and allows to determine the frequency of follow-up. The number of unnecessary fine-needle biopsies could be reduced, too. Our paper is part of a bigger research, the ethical license number is 23/2020, University of Szeged. Orv Hetil. 2021; 162(14): 530–541.


2000 ◽  
Vol 39 (01) ◽  
pp. 10-15 ◽  
Author(s):  
S. P. Müller ◽  
Ch. Reiners ◽  
A. Bockisch ◽  
Katja Brandt-Mainz

Summary Aim: Tumor scintigraphy with 201-TICI is an established diagnostic method in the follow-up of differentiated thyroid cancer. We investigated the relationship between thyroglobulin (Tg) level and tumor detectability. Subject and methods: We analyzed the scans of 122 patients (66 patients with proven tumor). The patient population was divided into groups with Tg above (N = 33) and below (N = 33) 5 ng/ml under TSH suppression or above (N = 33) and below (N = 33) 50 ng/ml under TSH stimulation. Tumor detectability was compared by ROC-analysis (True-Positive-Fraction test, specificity 90%). Results: There was no significant difference (sensitivity 75% versus 64%; p = 0.55) for patients above and below 5 ng/ml under TSH suppression and a just significant difference (sensitivity 80% versus 58%; p = 0.04) for patients above and below 50 ng/ml under TSH stimulation. In 18 patients from our sample with tumor, Tg under TSH suppression was negative, but 201-TICI-scan was able to detect tumor in 12 patients. Conclusion: Our results demonstrate only a moderate dependence of tumor detectability on Tg level, probably without significant clinical relevance. Even in patients with slight Tg elevation 201-TICI scintigraphy is justified.


Author(s):  
Steven Hurst

The United States, Iran and the Bomb provides the first comprehensive analysis of the US-Iranian nuclear relationship from its origins through to the signing of the Joint Comprehensive Plan of Action (JCPOA) in 2015. Starting with the Nixon administration in the 1970s, it analyses the policies of successive US administrations toward the Iranian nuclear programme. Emphasizing the centrality of domestic politics to decision-making on both sides, it offers both an explanation of the evolution of the relationship and a critique of successive US administrations' efforts to halt the Iranian nuclear programme, with neither coercive measures nor inducements effectively applied. The book further argues that factional politics inside Iran played a crucial role in Iranian nuclear decision-making and that American policy tended to reinforce the position of Iranian hardliners and undermine that of those who were prepared to compromise on the nuclear issue. In the final chapter it demonstrates how President Obama's alterations to American strategy, accompanied by shifts in Iranian domestic politics, finally brought about the signing of the JCPOA in 2015.


2020 ◽  
Author(s):  
Ananta Addala ◽  
Marie Auzanneau ◽  
Kellee Miller ◽  
Werner Maier ◽  
Nicole Foster ◽  
...  

<b>Objective:</b> As diabetes technology use in youth increases worldwide, inequalities in access may exacerbate disparities in hemoglobin A1c (HbA1c). We hypothesized an increasing gap in diabetes technology use by socioeconomic status (SES) would be associated with increased HbA1c disparities. <p> </p> <p><b>Research Design and Methods: </b>Participants aged <18 years with diabetes duration ≥1 year in the Type 1 Diabetes Exchange (T1DX, US, n=16,457) and Diabetes Prospective Follow-up (DPV, Germany, n=39,836) registries were categorized into lowest (Q1) to highest (Q5) SES quintiles. Multiple regression analyses compared the relationship of SES quintiles with diabetes technology use and HbA1c from 2010-2012 and 2016-2018. </p> <p> </p> <p><b>Results: </b>HbA1c was higher in participants with lower SES (in 2010-2012 & 2016-2018, respectively: 8.0% & 7.8% in Q1 and 7.6% & 7.5% in Q5 for DPV; and 9.0% & 9.3% in Q1 and 7.8% & 8.0% in Q5 for T1DX). For DPV, the association between SES and HbA1c did not change between the two time periods, whereas for T1DX, disparities in HbA1c by SES increased significantly (p<0.001). After adjusting for technology use, results for DPV did not change whereas the increase in T1DX was no longer significant.</p> <p> </p> <p><b>Conclusions: </b>Although causal conclusions cannot be drawn, diabetes technology use is lowest and HbA1c is highest in those of the lowest SES quintile in the T1DX and this difference for HbA1c broadened in the last decade. Associations of SES with technology use and HbA1c were weaker in the DPV registry. </p>


Author(s):  
Terence Young ◽  
Alan MacEachern ◽  
Lary Dilsaver

This essay explores the evolving international relationship of the two national park agencies that in 1968 began to offer joint training classes for protected-area managers from around the world. Within the British settler societies that dominated nineteenth century park-making, the United States’ National Park Service (NPS) and Canada’s National Parks Branch were the most closely linked and most frequently cooperative. Contrary to campfire myths and nationalist narratives, however, the relationship was not a one-way flow of information and motivation from the US to Canada. Indeed, the latter boasted a park bureaucracy before the NPS was established. The relationship of the two nations’ park leaders in the half century leading up to 1968 demonstrates the complexity of defining the influences on park management and its diffusion from one country to another.


2012 ◽  
Vol 39 (1) ◽  
pp. 1-51 ◽  
Author(s):  
Robert J. Kirsch

ABSTRACT Utilizing archival materials as well as personal interviews and correspondence with personnel of the Financial Accounting Standards Board (FASB) and International Accounting Standards Committee/Board (IASC/B), including former Board chairmen and staff members, this paper examines the development of the working relationships between the FASB and the IASC/B from their earliest interactions in 1973 through the transformation of the IASC into the IASB and the Convergence Program rooted in the 2002 Norwalk Agreement up to 2008.


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