Patterns of Analgesic Utilization in the Multicenter Study of Hydroxyurea (MSH).

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2577-2577 ◽  
Author(s):  
Samir K. Ballas ◽  
William F. McCarthy ◽  
Robert I Bauseman ◽  
Oswaldo L Castro ◽  
Paul S. Swerdlow ◽  
...  

Abstract Abstract 2577 Poster Board II-554 Introduction: Chronic and acute pain are characteristic of sickle cell disease (SCD). Opioids are often used at large doses to achieve pain relief. This report summarizes the relationship of patient characteristics to patterns of analgesic utilization by patients in MSH, including both at-home use and use during medical contacts requiring hospital utilization (ER or in-patient admission). Patients and Methods: The sample is the N=299 patients with homozygous SCD enrolled in the MSH, a randomized double-blind placebo-controlled study of hydroxyurea (HU) as a treatment for SCD. Details of the study have been previously reported (N Engl J Med 1995). Age was examined as 4 quartiles (ages 18–24, 25–29, 30–35, and 36+). For geographic location, MSH sites were clustered into 2 regions (North/South) and 4 regions (Northeast/NE, Midwest/MW, South and West). Data on analgesics use were from three sources. (1) At biweekly follow-up visits, providers recorded the type(s) and dosage of analgesic(s) used at home during that period. (2) In biweekly at-home diaries, patients reported any analgesic use each day. Data from the diaries and the follow-up visits were matched to calculate average daily doses for each biweekly period. (3) During medical contacts, providers recorded types and doses of parenteral and oral analgesics. All doses were converted into equianalgesic doses; those for hospital contacts were divided by contact duration to obtain daily averages. Results: Males and females did not differ in frequency of at-home analgesic use or the number of different analgesics used during each biweekly period. Equianalgesic dosing at home was numerically lower for females but the difference was not statistically significant. For hospital contacts, females were marginally less likely to report any analgesics use (p=.08) but reported more use of non-steroidal anti-inflammatories (NSAIDS) (p=.009). Equianalgesic dosing for parenteral analgesics was significantly lower for females (p=.015). There were significant age differences in at-home analgesic use. The 18–24 and 36+ quartiles used analgesics less often (p=.001) and used fewer total analgesics (p<.0001); however, equianalgesic dosing did not differ. During hospital contacts, parenteral analgesic use did not differ, but the 18–24 and 36+ age groups were more likely to use both oral analgesics (p=.009) and NSAIDS (p<.0001).By geographic location, there was extreme site-to-site variation. When grouped into 2 regions, lower in-hospital parenteral (p=.0007) dosing, marginally lower oral dosing (p=.09), and fewer total medications used (p=.08) were reported in the South. For 4 regions, frequency of at-home analgesic use and the total number of analgesics used were highest in the NE and lowest in the West. During hospital contacts, parenteral use was highest in the NE and lowest in the West, but the pattern was reversed for oral use and NSAIDs. Average daily dose in-hospital was lower in the South than in the NE or MW. Conclusion: In the MSH, patterns of analgesic utilization were sex, age, and location dependent. In hospital, females have lower dosing and less frequent use along with a greater likelihood of using NSAIDS, possibly substituting for parenteral use. By age, at-home use was lower in the youngest and oldest groups, and in hospital these age groups used more oral analgesics and NSAIDs – again, possibly substituting for parenteral use. Finally, regional differences suggested more frequent parenteral use in the NE, lower parenteral doses in the South, and more frequent oral and NSAID use in the West. Regional differences may reflect site- and provider-specific prescription policies and preferences, but sex and age may also significantly influence analgesic use in adult sickle cell patients. Disclosures: No relevant conflicts of interest to declare.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1513-1513 ◽  
Author(s):  
Samir K. Ballas ◽  
William F. McCarthy ◽  
Robert L Bauserman ◽  
Faramarz Valafar ◽  
Myron Waclawiw ◽  
...  

Abstract Abstract 1513 Poster Board I-536 Introduction Treatment of sickle cell anemia with hydroxyurea (HU) is associated with significant decreases in the frequency of painful crises, acute chest syndrome, morbidity, and mortality. Some patients, however, show no improvement even with prolonged HU therapy. Identifying treatment responders is important for predicting clinical improvements and for assessing the risk/benefit ratio of HU treatment for individual patients. The salutary effects of HU are thought to be the result of increasing the fetal hemoglobin (Hb F) level. NHLBI guidelines for sickle cell treatment define levels of 15%-20% Hb F as therapeutic endpoints. Research and reviews based on pediatric and adult patients have variously argued that levels from about 10% to 20% are beneficial. Patients and Methods Patients in this study were from the Multicenter Study of Hydroxyurea (MSH) in Sickle Cell Anemia, a randomized double-blind placebo controlled trial of HU. The N=299 adult patients were recruited from 21 sites across the U.S. and Canada, and were evenly distributed between males and females. Following randomization to placebo or HU, patients had biweekly follow-up visits until the trial was terminated early due to a significant reduction in painful crises (the primary study endpoint) in the HU arm. Levels of Hb F in MSH patients were assessed at baseline and again approximately 18-21 months after treatment began, with the level at each time being the average of two measurements. In the previously reported MSH study, patients were divided into quartiles of Hb F change as a measure of response to HU treatment. In this approach the bottom two quartiles showed either no or minimal positive change in Hb F levels, and fully overlapped with placebo group in the extent of change. We redefined HU patients as ‘responders’ or ‘nonresponders’ based on a 15% Hb F threshold; those with baseline HbF below 15% and follow-up above 15% were labeled ‘responders,’ while all others were labeled ‘nonresponders.’ The 15% level was chosen due to its frequent identification in previous publications as a level at which meaningful benefits could be expected. For both coding schemes, we compared the following outcomes between subgroups: rate of painful crises, proportion of days at home with pain and with opioid use, and average daily pain. Results Using the 15% rule, responders had significantly better outcomes than nonresponders on all outcome measures: rate of painful crises (p=.011), proportion of at-home days with pain (p=.025), proportion of days with analgesic use (p=.002), and average daily pain (p<.0001). Nonresponders, in turn, did not differ from the placebo group on any of these outcomes. Using the quartiles approach, the highest quartile had significantly fewer painful crises (p<.05) than the bottom two and placebo, but did not differ from the second highest; for the proportion of days with pain, the highest group did not differ from 2 of the other 3 quartiles or from the placebo group. Only for proportion of days with analgesic use and average daily pain did the highest quartile significantly differ from all other quartiles and from placebo patients. Finally, applying the 15% rule to the pl‘cebo group resulted in no placebo patients being mislabeled as treatment responders, suggesting that increases above the 15% cutoff for post-treatment Hb F levels is outside normal variability in sickle cell patients not in HU treatment. Conclusions The 15% Hb F rule successfully identified a ‘responder’ group that significantly differed from other HU patients and from placebo patients on all outcomes, including painful crises. Despite overlap with responders under the 15% rule, patients in the highest quartile for Hb F change did not consistently differ from all other quartiles or placebo on the primary outcome (painful crises) and on proportion of days with pain. Our data suggest that using the 15% Hb F threshold identifies a subset of patients with the best clinical outcomes. Disclosures No relevant conflicts of interest to declare.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1066-1066 ◽  
Author(s):  
Abdullah Kutlar ◽  
Adlette Inati ◽  
Ali T Taher ◽  
Amal El-Beshlawy ◽  
Marvin Reid ◽  
...  

Abstract Abstract 1066 Fetal hemoglobin (Hb F) induction (anti-switching therapy) is an effective therapeutic strategy in sickle cell disease (SCD), both for reducing acute complications such as painful episodes and acute chest syndrome, and decreasing hospitalizations and transfusion requirements. Long term use of the only approved anti-switching agent, hydroxyurea (HU) has also been shown to improve survival. Despite this, HU is still not widely prescribed, ∼30% of patients are non-responders, and there are concerns regarding long term use of this cytotoxic agent. There is, therefore, a clear need for alternative anti-switching agents with different mechanism(s) of action, that are not cytotoxic, and that could be used either alone, or in combination with HU to enhance Hb F response. HQK-1001, an orally bioavailable short-chain fatty acid, was shown to promote Hb F synthesis and prolong erythroid survival and proliferation in transgenic mice and non-human primate models. In a Phase 1/2, dose-escalation, placebo-controlled study in 24 patients with SCD, HQK-1001 given at 10, 20, and 30 mg/kg/day for 12 weeks was well tolerated, showed dose-proportional pharmacokinetics (PK), and resulted in dose-dependent increase in Hb F (A Kutlar et al, Blood 2010; 116: Abstract 943). This randomized open-label Phase 2 study is being conducted to evaluate the safety, PK, and effect on Hb F of HQK-1001 administered at a higher dose and for a longer duration than previously studied. Patients with SCD age 12 years and greater were randomized to receive HQK-1001 at 30 or 40 mg/kg daily for 26 weeks. Enrollment at the 50 mg/kg dose level was opened after the Safety Monitoring Committee conducted a planned interim safety data review of the first 12 patients treated for 4 weeks. HQK-1001 is administered as 900 mg tablets, and daily oral iron supplementation is given to patients with plasma ferritin levels less than 700 ng/mL. A minimum of 14 patients stratified 1-to-1 by HU use at baseline will be enrolled at each dose level. Between 25 April 2011 and 5 August 2011, 39 patients have been enrolled and received HQK-1001 at 30 mg/kg (n = 14), 40 mg/kg (n = 14), and 50 mg/kg (n = 11). Patients were enrolled in North America (n = 18), Lebanon (n = 15) and Egypt (n = 6). Median age was 22 years (range, 12–47) and 7 (18%) were less than 18 years old. There were 20 (51%) males and 19 (49%) females. Patients had either Hb-SS (n = 34) or Hb-Sβ0 (n = 5), and 25 (64%) were on HU at baseline and continued HU while on study. Four patients have discontinued HQK-1001 per protocol following a transfusion to treat a SCD complication. One patient discontinued HQK-1001 due to pancreatitis. This patient was found to have a stone in the common bile duct and subsequently died postoperatively from multiorgan failure. The most common adverse events considered by the investigator as possibly drug-related were nausea in 10 patients (26%), abdominal/epigastric pain, vomiting, and headache in 5 (13%) each, and somnolence and dizziness in 3 (8%) each. Drug-related adverse events were graded as mild or moderate except for 1 case each of pancreatitis and gastritis graded as severe. No myelosuppression was observed. Assessment of HQK-1001 effect on Hb F and hemoglobin (Hb) is limited due to short follow-up. In 19 patients in which baseline and Week 4 data are available, the mean value at baseline for Hb was 8.9 g/dL (range, 7.4–11.4) and for Hb F was 1.11 g/dL (range, 0.15–3.33). Eight patients had data available both for Weeks 4 and 8. On Week 8, total Hb increased from baseline by a mean of 0.3 g/dL (range, −0.7 to 1.2) and Hb F increased by a mean of 0.14 g/dL (range, −0.19 to 0.42). The figure reports individual changes in Hb F from baseline to Weeks 4 (dark bars) and Week 8 (light bars), with “X” denoting the 4 patients on HU, and shows an increase in Hb F in 7 of 8 patients for that period. Enrollment is expected to be completed in August 2011 and updated results will be available at the meeting. In conclusion, the safety profile of HQK-1001 is consistent with results reported in prior studies and shows no overlapping toxicity with HU. Hb F is apparently increased in 7 of 8 patients with data available at Week 8, and this increase is seen both in patients receiving HU or not. Longer follow-up is needed to fully assess the safety of HQK-1001 and the extent of its effect on Hb F, total Hb, and SCD-related events. Disclosures: Aiello: HemaQuest Pharmaceuticals: Employment. Johnson:HemaQuest Pharmaceuticals: Employment. White:HemaQuest Pharmaceuticals: Consultancy. Ghalie:HemaQuest Pharmaceuticals: Employment.


2021 ◽  
Vol 12 ◽  
Author(s):  
Maria Girolama Raso ◽  
Francesco Arcuri ◽  
Stefano Liperoti ◽  
Luca Mercurio ◽  
Aldo Mauro ◽  
...  

Telehealth systems have shown success in the remote management of several neurological disorders, but there is a paucity of evidence in disorders of consciousness (DOC). In this study, we explore the effectiveness of a new telemonitoring system, for monitoring Vegetative State (VS) and Minimally Conscious State (MCS) patients. This was a prospective, mono-center randomized controlled study. We included only traumatic brain injury (TBI) patients who required long-term motor/cognitive assistance having a stable clinical condition. We examined their clinical evolution over ~4 years of the follow-up period. Twenty-two TBI patients were enrolled and equally divided into two groups: one telemonitored at home with our service and the second admitted to a standard long-stay hospitalization (LSH) program. Patients enrolled in the telehealth service (age: 49.9 ± 20.4; 45% female; diagnosis: 36% VS/64% MCS) were demographically and clinically-matched with those admitted to the LSH program (age: 55.1 ± 15; 18% female; diagnosis: 54% VS/46% MCS). Thirty-six percent of patients in the LSH program died before completing follow up evaluation with respect to 18% of death in the group of TBI patients telemonitored at home. At follow-up, patients in LSH and telemonitoring groups showed similar clinical progression, as measured by CRS-r, NCS, WHIM, and LCF scales, as well as by the number of medical complications (i.e., bedsores, infections). Finally, we estimated the total daily cost per patient. Severe TBI patients enrolled in the conventional LSH program cost 262€ every single day, whereas the cost per patient in the telehealth service resulted to be less expensive (93€). Here, we highlight that our telehealth monitoring service is as efficacious as in-person usual care to manage a severe neurological disorder such as TBI in a cost-effective way.


2021 ◽  
pp. 1-10
Author(s):  
Olaitan Okunoye ◽  
Laura Horsfall ◽  
Louise Marston ◽  
Kate Walters ◽  
Anette Schrag

Background: Hospitalization in Parkinson’s disease (PD) is associated with reduced quality of life, caregiver burden and high costs. However, no large-scale studies of rate and causes of hospitalizations in patients with PD have been published. Objective: To investigate the rate and reasons for hospitalization and factors associated with hospitalization among people with PD compared to the general population. Methods: We examined rate and causes of admission in PD patients and matched controls in The Health Improvement Network from 2006 to 2016. Multivariable Poisson regression was used to explore the effects of age, gender, social deprivation, urbanicity and practice geographic location on hospitalization. Results: In longitudinal data from 9,998 newly diagnosed individuals with PD and 55,554 controls without PD aged≥50years, 39%of PD patients and 28%of controls were hospitalised over a median follow-up 5.1years. The adjusted incidence rate ratio(IRR) of hospitalization in PD compared to controls was 1.33(95%CI:1.29–1.37) and rose with increased follow-up duration. Hospitalization rate was overall higher in the older age groups, but the adjusted IRR of hospitalization compared to controls was highest in the youngest age group. PD patients were more often admitted with falls/fractures, infections, gastrointestinal complications, PD, dementia, psychosis/hallucinations, postural hypotension, electrolyte disturbances, stroke and surgical procedures and slightly less often due to hypertension. Conclusion: People with PD have an increased hospitalization rate compared to controls, particularly in the younger age groups, and it increases with longer disease duration. The complications of motor and non-motor features of PD are amongst the main reasons for admission, some of which could be managed preventatively to avoid admissions.


2019 ◽  
Vol 2 (2) ◽  
pp. 107-120
Author(s):  
Gatot Iwan Kurniawan

The South Coast Special Interest Area of ​​South West Java is an area that will be developed based on the West Java Province Tourism Development Master Plan in 2016-2025. This plan is a follow-up to the Indonesian Government's program that continues to improve the tourism sector. the success of the development is expected to significantly increase the number of visitors. It should be understood that increasing visitors will increase foreign exchange and the economy of the community but will lead to a risk. This study aims to make risk assessments that occur in this area so that it will provide prevention information on risks that might occur. Qualitative results are observed and interviewed. it was found that the risk was caused by low public awareness, lack of preparedness of the local government in developing the tourism sector, a conflict of interest because the south coast was owned by three districts and other reasons.


2014 ◽  
Vol 32 (26_suppl) ◽  
pp. 104-104
Author(s):  
Meeghan Ann Lautner ◽  
Heather Y. Lin ◽  
Yu Shen ◽  
Catherine Parker ◽  
Henry Mark Kuerer ◽  
...  

104 Background: Since 1990 breast conserving therapy (BCT) has become a widely accepted modality in the treatment of breast cancer. However, many women continue to undergo mastectomy over BCT. The objective of this study was to provide a comprehensive population based review of the factors that influence utilization of BCT. Methods: Using the National Cancer Database (NCDB), we evaluated women who underwent a mastectomy or BCT for T1/T2, any N breast cancer between 1998 and 2011. We conducted a retrospective review of patient and facility variables associated with undergoing BCT and the trends over time. Logistic regression analysis was used to assess the multivariate relationship between these variables and the probability of undergoing BCT. Results: Among the 727,927 patients who met study criteria, BCT rates increased from 54% in 1998 to 59% in 2006 and then stabilized. After adjusting for demographic and clinical characteristics, BCT utilization was more likely in patients aged 52-61 compared to younger patients (odds ratio (OR) 1.14 {95% CI 1.12-1.15}) and in those with the highest education level (OR 1.16 {95% CI 1.14-1.19}). BCT rates were higher in patients with private insurance compared to the uninsured (OR 1.33 {95% CI 1.28-1.38}) and in those with the highest median income (OR 1.09 {95% CI 1.06-1.11}) (all p < 0.0001). Academic Cancer Programs, facilities in the Northeast and patients who lived within 17 miles of a treatment facility had higher utilization of BCT than Community Cancer Programs (OR 1.13 {95% CI 1.11-1.15}), facilities located in the South (OR 1.50 {95% CI 1.48-1.52}) and those who lived further from a treatment facility (OR 1.25 {95% CI 1.23-1.27}) (all p<0.0001). When comparing BCT utilization in 1998 and 2011, increases were seen across age groups, in community cancer programs and in facilities located in the South; however, disparities by insurance status, income level and travel greater than 17 miles to a treatment facility persist. Conclusions: BCT rates have increased during the last two decades. Disparities based on age, geographic location and type of cancer program have improved. However, socio-economic status and travel distance to treatment facilities persist as key barriers to BCT utilization.


1928 ◽  
Vol 11 ◽  
pp. 61-82
Author(s):  
E. M. Carus-Wilson

Ashrewd Italian visitor, writing of England more than four hundred years ago, remarked:—“There are scarcely any towns of importance in the kingdom excepting these two: Bristol, a seaport to the West, and Boraco, otherwise York, which is on the borders of Scotland; besides London to the South.” Now York was not a port, though it traded far afield through Hull; London was a port, but it was so much else that its story is confusingly complex; moreover it was not by the Thames but by the Severn that Englishmen first found a pathway to the New World at the end of the Middle Ages. Hence Bristol, then the second port in England, is of peculiar interest to the student of the still unwritten history of English commerce in the fifteenth century—a history unchronicled, but not unrecorded, and quite as significant as the wars abroad and the strifes at home which have too often earned for the century a character of futility.


2021 ◽  
Author(s):  
Emma Zang ◽  
Jessica West ◽  
Nathan Kim ◽  
Christina Pao

AbstractHealth varies by U.S. region of residence. Despite regional heterogeneity in the outbreak of COVID-19, regional differences in physical distancing behaviors over time are relatively unknown. This study examines regional variation in physical distancing trends during the COVID-19 pandemic and investigates variation by race and socioeconomic status (SES) within regions.Data from the 2015-2019 five-year American Community Survey were matched with anonymized location pings data from over 20 million mobile devices (SafeGraph, Inc.) at the Census block group level. We visually present trends in the stay-at-home proportion by Census region, race, and SES throughout 2020 and conduct regression analyses to statistically examine these patterns.From March to December, the stay-at-home proportion was highest in the Northeast (0.25 in March to 0.35 in December) and lowest in the South (0.24 to 0.30). Across all regions, the stay-at-home proportion was higher in block groups with a higher percentage of Blacks, as Blacks disproportionately live in urban areas where stay-at-home rates were higher (0.009 [CI: 0.008, 0.009]). In the South, West, and Midwest, higher-SES block groups stayed home at the lowest rates pre-pandemic; however, this trend reversed throughout March before converging in the months following. In the Northeast, lower-SES block groups stayed home at comparable rates to higher-SES block groups during the height of the pandemic but diverged in the months following.Differences in physical distancing behaviors exist across U.S. regions, with a pronounced Southern and rural disadvantage. Results can be used to guide reopening and COVID-19 mitigation plans.


PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0259665
Author(s):  
Emma Zang ◽  
Jessica West ◽  
Nathan Kim ◽  
Christina Pao

Health varies by U.S. region of residence. Despite regional heterogeneity in the outbreak of COVID-19, regional differences in physical distancing behaviors over time are relatively unknown. This study examines regional variation in physical distancing trends during the COVID-19 pandemic and investigates variation by race and socioeconomic status (SES) within regions. Data from the 2015–2019 five-year American Community Survey were matched with anonymized location pings data from over 20 million mobile devices (SafeGraph, Inc.) at the Census block group level. We visually present trends in the stay-at-home proportion by Census region, race, and SES throughout 2020 and conduct regression analyses to examine these patterns. From March to December, the stay-at-home proportion was highest in the Northeast (0.25 in March to 0.35 in December) and lowest in the South (0.24 to 0.30). Across all regions, the stay-at-home proportion was higher in block groups with a higher percentage of Blacks, as Blacks disproportionately live in urban areas where stay-at-home rates were higher (0.009 [CI: 0.008, 0.009]). In the South, West, and Midwest, higher-SES block groups stayed home at the lowest rates pre-pandemic; however, this trend reversed throughout March before converging in the months following. In the Northeast, lower-SES block groups stayed home at comparable rates to higher-SES block groups during the height of the pandemic but diverged in the months following. Differences in physical distancing behaviors exist across U.S. regions, with a pronounced Southern and rural disadvantage. Results can be used to guide reopening and COVID-19 mitigation plans.


2021 ◽  
pp. 104063872110560
Author(s):  
Jaclyn A. Willette ◽  
Jamie J. Kopper ◽  
Clark J. Kogan ◽  
M. Alexis Seguin ◽  
Harold C. Schott

We investigated the effects of season and geographic location on detection of nucleic acids of potential enteric pathogens (PEPs) or their toxins (PEP-Ts) in feces of horses ≥6-mo-old in the United States. Results of 3,343 equine diarrhea PCR panels submitted to Idexx Laboratories for horses >6-mo-old were reviewed. Submission months were grouped into 4 seasons, and states were grouped into 4 geographic regions. Logistic regression was performed to assess effects of season and region on detection rates of PEPs and PEP-Ts. Agresti–Coull CIs were determined. Detection rate of Salmonella enterica was higher in the South in summer compared to all other regions, and was also higher in the South in fall compared to the Midwest and Northeast. The Neorickettsia risticii detection rate was lower during summer in the West and higher in fall in the Midwest. Detection of Cryptosporidium spp. was lower during spring, summer, and winter in the West. Differences were not identified for detection rates of Clostridioides difficile, Clostridium perfringens, Lawsonia intracellularis, Rhodococcus equi, equine rotavirus, and equine coronavirus. Overall, our data support seasonal and regional differences in detection rates of S. enterica, N. risticii, and Cryptosporidium spp. in horses ≥6-mo-old in the United States.


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