Real-world treatment of metastatic hormone-sensitive prostate cancer in the USA, Europe and Asia.

Aim: To characterize real-world patients with metastatic hormone-sensitive prostate cancer (mHSPC) and treating physicians and evaluate treatment trends and baseline concordance versus guidelines internationally. Materials & methods: Retrospective, cross-sectional data from the Ipsos Global Oncology Monitor database 2018-2020 were used for descriptive analysis of mHSPC patients, treating physicians and treatment utilization. Results: Among the 6198 mHSPC patients from five countries, the most common treatment was either androgen deprivation therapy (ADT) monotherapy or first-generation androgen receptor inhibitor + ADT. Second-generation androgen receptor inhibitor use was only initiating but increasing over the study period. Conclusion: Despite contemporaneous guidelines recommending treatment intensification of ADT in combination with novel antihormonals or docetaxel, 76.1% of reported mHSPC patients received non-guideline-concordant care.

Prostate cancer is the second most common cancer among men worldwide and a leading cause of cancer-related death globally. Metastatic hormone-sensitive prostate cancer (mHSPC) refers to the stage of prostate cancer where it has spread to other parts of the body ('metastatic') but still responds to hormonal therapy ('hormone-sensitive'), such as androgen deprivation therapy (ADT). Treatment guidelines around the world for men with mHSPC have changed over time, but there remains a lack of understanding of how well guidelines are followed in real-world practice. Consequently, this study analyzes real-world data from five countries between 2018 and 2020 to understand treatment patterns, baseline concordance versus guidelines and potential drivers of treatment trends. The study found prevalent use of ADT monotherapy and older antihormonal agents, and only marginal but increasing use of novel antihormonals in real-world practice. These practices deviate from guidelines from the study period, which generally recommended ADT combination with either newer antihormonal agents or docetaxel for patients with mHSPC. Overall, the proportion of the 6198 patients treated with non­guideline-concordant therapies was 76.1%. Since guideline-recommended care is associated with better outcomes, this baselining finding highlights the need for appropriate treatment selection and intensification for mHSPC patients.

Evaluating Treatment Choice in Patients with Moderate to Severe Psoriasis in the United States: Results from a US Patient Survey.

INTRODUCTION: While multiple treatments are available for moderate to severe psoriasis, patient preferences are rarely systematically studied. This study aims to identify factors associated with choice of a new once-daily oral psoriasis treatment, elicit patient views on treatment characteristics, and rank treatment characteristics by importance. METHODS: This noninterventional, cross-sectional survey study, conducted from December 2021 to June 2022, recruited US adults with moderate to severe psoriasis. Demographics, clinical characteristics, and perspectives on psoriasis treatment were collected. Factors associated with the choice of a new oral treatment were identified using multivariable logistic regression analysis. Treatment characteristics and reasons for treatment choice were ranked using bivariate comparisons. RESULTS: The study included 882 participants [mean (standard deviation; SD) age, 45.7 (12.8) years; female, 67.7%; White, 74.9%]; 92.7% were currently receiving treatment [mean (SD) duration, 2.9 (4.8) years]. Half of participants rated their psoriasis symptoms over the past week as mild, very mild, or nonexistent; 36.5% as moderate; and 12.7% as severe or very severe. Most (66.5%) indicated willingness to start a new oral treatment; 65.0% indicated that the new oral treatment would cause less anxiety than injections/infusions. Participants were significantly more likely to start the new oral treatment if they were currently receiving a tumor necrosis factor inhibitor [odds ratio (OR): 2.1, 95% confidence interval (CI): 1.4-3.1] or ustekinumab (OR: 2.7, 95% CI: 1.6-5.0) versus apremilast (P < 0.001) or if they reported mild (OR: 3.2, 95% CI: 2.0-4.9), moderate (OR: 5.0, 95% CI: 3.1-8.2), or severe (OR: 7.6, 95% CI: 3.9-15.0) psoriasis symptoms compared with those who reported no symptoms in the past week (P < 0.001). CONCLUSION: Most participants indicated willingness to start a new once-daily oral treatment, viewing it as less anxiety provoking than injections/infusions. Current treatment and psoriasis severity affected participants' willingness to start a new oral treatment.

Patients with psoriasis have multiple treatment options available to them. We surveyed 882 adults with moderate to severe psoriasis in the US to assess their perspectives and the values placed on treatment characteristics that are most important to them when making treatment-related decisions. Participants were assigned to one of five groups based on their psoriasis treatment at the time of the survey: (1) apremilast (oral), (2) a tumor necrosis factor inhibitor (TNFi) treatment (injectable), (3) ustekinumab (injectable), (4) a topical therapy or phototherapy, or (5) over-the-counter medications or participants who were untreated (this group included those who were not currently using a psoriasis treatment). The extent of skin clearance associated with a drug, how a drug is taken, and a drug's safety profile were among the top-ranked treatment characteristics that are important to survey participants when they choose a psoriasis treatment. Most participants (66.5%) were willing to start a new oral treatment, with 65.0% indicating that the new oral treatment would cause less anxiety than injections or infusions. Participants were more willing to switch to a new oral psoriasis treatment if they were currently receiving an injectable treatment, such as ustekinumab or a TNFi, compared with those who were already taking an oral treatment. These findings suggest that, when prescribing treatments for psoriasis, health care providers should consider the treatment characteristics that are important to their patients and consider that patients generally prefer an oral versus injectable drug.

Pain management practices for outpatients with breast cancer.

Objectives: Pain is a significant problem in patients with breast cancer. Limited data exist regarding the nature and extent of pain management in women with breast cancer visiting outpatient settings. This study examined the pain management practices and the factors associated with prescribing pain medications among breast cancer patients. Methods: This cross-sectional study used the National Ambulatory Medical Care Survey (NAMCS) 2011-2016, nationally representative outpatient survey data. Women (age ≥18 years) with breast cancer as the primary diagnosis were included. Weighted descriptive analyses examined national-level pain management practices, while multivariable logistic regression evaluated the factors associated with the prescribing of pain medications and opioids. Results: There were 23.95 million (95% confidence interval [CI], 19.29-28.60) outpatient visits for breast cancer during the study period. Pain medications were prescribed in 27.12% of these visits, with non-opioids prescribed in 17.13% and opioids in 15.16% of visits. Logistic regression analyses revealed that patients on Medicaid/other state-based insurance (odds ratio [OR] =2.38, 95% CI:1.15-4.93), those visiting general/family practice physicians (OR = 3.18, 95% CI:1.22-8.29) and patients receiving adjuvant pain medications (OR = 4.74, 95% CI: 3.10-7.24) were associated with a greater odds of receiving pain medications; while patients who were white (OR = 0.50, 95% CI:0.3-0.85), those residing in the northeast region (OR = 0.31, 95% CI: 0.10-0.99), and non-primary care provider visits (OR = 0.37, 95% CI:0.15-0.94) were associated with lower odds of receiving pain medications. Regional variations were observed among those receiving pain medications: women in the Northeast (OR = 0.06, 95% CI:0.01-0.29), Midwest (OR = 0.15, 95% CI:0.04-0.62), and South (OR = 0.24, 95% CI:0.06-0.92) regions were less likely to receive opioids. However, patients visiting general and family practice specialties (OR = 6.76, 95% CI:1.71-26.70) were more likely to prescribe opioids than non-opioids. Conclusions: The national survey data revealed one in four women visits and one in seven office visits for breast cancer received pain medication prescriptions and opioid medications, respectively. Both patient and provider characteristics contribute to variations in pain management in breast cancer patients. Further research is needed to evaluate the long-term consequences of these variations in breast cancer.

Real-world use of inhaled nitric oxide therapy in patients with COVID-19 and mild-to-moderate acute respiratory distress syndrome.

Background: Inhaled nitric oxide (iNO) has been studied in patients with severe acute respiratory distress syndrome (ARDS) due to COVID-19 when it may be too late to impact disease course. This article aims to describe real-world iNO use and outcomes in patients with COVID-19 with mild-to-moderate ARDS in the United States. Methods: This was a retrospective medical chart review study that included patients who were ≥18 years old, hospitalized for COVID-19, met the Berlin ARDS definition, received iNO for ≥24 hours continuously during hospitalization, and had a partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio (P/F ratio) of >100 to ≤300 mmHg at iNO initiation. Outcomes included oxygenation parameters, physician-rated Clinical Global Impression-Improvement (CGI-I) scale scores, and adverse events. Response to iNO was defined as >20% improvement in P/F ratio. Results: Thirty-seven patients at six sites were included. A P/F ratio of ≤100 was the most common reason for exclusion (n=146; 83% of excluded patients). The mean P/F ratio (SD) increased from 136.7 (34.4) at baseline to 140.3 (53.2) at 48 hours and 151.8 (50.0) at 72 hours after iNO initiation. The response rate was 62% (n=23). During hospitalization, no patient experienced adverse events, including methemoglobinaemia, airway injury, or worsening pulmonary oedema associated with iNO. At discharge, 54.0% (n=20) of patients improved or remained stable according to the CGI-I. Conclusion: In patients hospitalized with COVID-19 and mild-to-moderate ARDS, iNO was associated with improvement in the P/F ratio with no reported toxicity. This study provides additional evidence supporting a favourable benefit-risk profile for iNO in the treatment of mild-to-moderate ARDS in patients with COVID-19 infection.

Cost Burden of Endothelial Keratoplasty in Fuchs Endothelial Dystrophy: Real-World Analysis of a Commercially Insured US Population (2014-2019).

Purpose: To assess the incremental burden of corneal transplant surgery for US commercially insured patients with Fuchs endothelial corneal dystrophy (FECD) treated with endothelial keratoplasty (EK) compared to controls. Methods: The study design was retrospective cohort using IBM® MarketScan® claims (January 2014-September 2019) and included EK-treated (N=1562) and control patients (N=23,485) having ≥12 months' enrollment before and after diagnosis, who were subsequently matched on select characteristics. The index date was the beginning of the pre-operative period (3 months before EK); synthetic EK index was assigned for controls. All-cause, eye-disease, and complication-related healthcare resource utilization (HCRU) and costs were compared up to 36 months post index. For a small subset of patients, patient data were linked to the Health and Productivity Management supplemental database, which integrates data on productivity loss and disability payments. Results: Matched cohorts included 804 EK-treated and 1453 controls with average age 65.7 years, 1383 (61%) female. Over 12 months of follow-up, all-cause ($41,199 vs $20,222, p<0.001) and eye-disease related costs ($22,951 vs $1389, p<0.001) were higher among EK-treated patients than controls. The cost differential increased additionally by $1000-$2000 per annum by 36 months of follow-up. While balanced at baseline, over follow-up EK-treated patients had higher prevalence of glaucoma, elevated intraocular pressure, cataract, cataract surgery, diagnosis of cornea transplant rejection, retinal edema. By 36 month of follow-up, EK-treated patients had 9 more short-term disability days, resulting in $2992 additional burden of disability payments. Conclusion: This study found a higher cost burden among FECD patients receiving EK treatment versus those who did not. With a shift in management of FECD, cost burden estimates generated in this study could serve as an important benchmark for future studies.

National surveys to evaluate prescribing practices: Methodological considerations.

With the changing healthcare landscape, evaluating the care provision in ambulatory settings is vital to understand outpatient care. The national surveys such as the National Ambulatory Medical Care Survey (NAMCS) and the National Hospital Ambulatory Medical Care Survey (NHAMCS) are valuable resources to pharmacy researchers because of their availability and generalizability. With the recent focus on real-world data, the national surveys are critical in providing practice and policy evidence by evaluating ambulatory care, especially prescribing practices. The use of these surveys requires an understanding of the survey content, scope, complex sampling scheme, and analytical and research considerations. There are several methodological and practical considerations that make these national surveys useful to both novice and seasoned researchers. Although some generalized approaches are available for analyzing the national surveys, there is limited focus on the NAMCS and the NHAMCS. This paper provides an in-depth understanding of the NAMCS/NHAMCS, including methodological considerations for evaluating prescribing practices in ambulatory settings.

Antipsychotic Initiation Among Older Dementia Patients Using Cholinesterase Inhibitors: A National Retrospective Cohort Study.

BACKGROUND: Evidence regarding the initiation of antipsychotic medications across individual cholinesterase inhibitors (ChEIs) to manage the behavioral symptoms of dementia is lacking. OBJECTIVES: This study compared the risk of initiation of antipsychotic medications among older adults with dementia treated with the ChEIs donepezil, rivastigmine, or galantamine. METHODS: This retrospective cohort study used multiyear (2013-2015) Medicare claims data involving Parts A, B, and D. The study sample included community-dwelling older adults (aged ≥ 65 years) with a diagnosis of dementia. The study identified new users of ChEIs and followed them for up to 180 days for antipsychotic initiation. The ChEIs included donepezil, rivastigmine, and galantamine, whereas antipsychotics included typical and atypical agents. Donepezil was used as the reference category as it is the most commonly used ChEI and only acts on acetylcholinesterase, whereas both rivastigmine and galantamine have dual mechanisms of action. Multivariable Cox proportional hazards regression compared the risk of and time to antipsychotic initiation among the three ChEIs, adjusting for other risk factors. RESULTS: The study cohort consisted of 178,441 older adults with dementia who were new users of ChEIs. A total of 23,433 (15.14%) donepezil users, 4114 (19.04%) rivastigmine users, and 324 (15.77%) galantamine users initiated antipsychotics. The mean time to antipsychotic initiation among patients who received antipsychotics was 109.29 ± 69.72 days for donepezil users, 96.70 ± 71.60 days for rivastigmine users, and 104.15 ± 72.53 days for galantamine users. The Cox regression analysis showed that rivastigmine (adjusted hazard ratio [aHR] = 1.27; 95% confidence interval [CI], 1.20-1.34) was significantly associated with antipsychotic initiation compared with donepezil, whereas no significant difference was observed between galantamine and donepezil (aHR = 0.98; 95% CI, 0.81-1.20). CONCLUSION: The study found a 27% increased risk of antipsychotic initiation among users of rivastigmine compared with donepezil users. There was no difference between galantamine and donepezil for antipsychotic initiation. Although the limitations of the study should be considered, the results suggest that donepezil or galantamine may be more appropriate treatments for older patients with dementia, to minimize antipsychotic use.

Opioid Prescribing Among Outpatients with Rheumatoid Arthritis.

STUDY OBJECTIVES: To examine the outpatient opioid prescribing practices and the factors associated with opioid prescriptions in patient visits with rheumatoid arthritis (RA). DESIGN: This cross-sectional study used the 2011-2016 National Ambulatory Medical Care Survey. Descriptive weighted analyses were used to examine the trends in opioid prescribing practices for RA. Multivariable logistic regression was used to examine the factors associated with opioid prescriptions among RA visits. SUBJECTS: Adult patients (>18 years of age) with a primary diagnosis of RA based on the International Classification of Diseases. RESULTS: According to the national surveys, an average of 4.45 (95% confidence interval [CI], 2.30-6.60) million office visits were made annually for RA. Approximately 24.28% of these visits involved opioid prescriptions. The RA visits involving opioid prescriptions increased from 1.43 million in 2011-2012 to 3.69 million in 2015-2016 (P < .0001). Being in the age group of 50-64 years (odds ratio [OR] = 3.40; 95% CI, 1.29-9.00), being Hispanic or Latino (OR = 2.92, 95% CI, 1.10-7.74), visiting primary physician (OR = 4.67; 95% CI, 1.86-11.75), prescribing of muscle relaxants (OR = 64.32; 95% CI, 9.71-426.09), acetaminophen (OR = 93.40; 95% CI, 26.19-333.04), antidepressants (OR = 6.10; 95% CI, 2.63-14.14), and glucocorticoids (OR = 3.20; 95% CI, 1.61-6.38), were associated with an increased likelihood of receiving opioid prescriptions in RA. CONCLUSIONS: One in four adult RA visits resulted in opioid prescriptions, and the opioid visits more than doubled during the study period. Several patient and provider factors were associated with the opioid prescribing among RA visits. Understanding these prescribing practices can help to devise strategies for safe opioid prescribing practices in RA.

Examination of physicians' adherence to the 2013 ACC/AHA statin/cholesterol guidelines using a framework of awareness to adherence: A cross-sectional study.

BACKGROUND: Currently, limited data exists regarding primary care physicians' awareness and implementation of the 2013 cholesterol guidelines. OBJECTIVES: To evaluate primary care physicians' adherence to the 2013 ACC/AHA cholesterol management guidelines using the framework of the awareness-to-adherence model. METHODS: The study was a cross-sectional pre-post survey design based on the constructs of the awareness-to-adherence model to capture physicians' awareness of, agreement with, adoption of, and adherence to the 2013 ACC/AHA guidelines for cholesterol treatment and statin and cholesterol management software applications. Physicians with a Medicare Advantage organization in Texas were surveyed before and after educational interventions. RESULTS: A total of 170 responses were considered usable (post-survey). A significant difference was observed when physicians were divided into 2 groups (any intervention vs no intervention) (P = .027). Physicians with a higher level of agreement were 4.8 times more likely to be adherent to the guidelines (P = .011), compared with those with a lower level of agreement. Also, physicians practicing in the Rio Grande Valley area were 4.7 times more likely to be adherent to the guidelines (P = .001) compared with those from the Greater Houston area. CONCLUSION: A high level of awareness, but a lower level of adherence to the guidelines was reported among responding physicians. The awareness-to-adherence model was useful in examining physicians' level of adherence to the cholesterol guidelines and the utilization of statin and cholesterol management cellular apps and online websites. Future studies are required to examine physicians' adoption and adherence of new guidelines.

Documentation of asthma control and severity in pediatrics: analysis of national office-based visits.

Objective: To evaluate the extent of documentation of asthma control and severity and associated characteristics among pediatric asthma patients in office-based settings. Methods: This cross-sectional study utilized data from the 2012-2015 National Ambulatory Medical Care Survey (NAMCS). Patients aged 6-17 years with a diagnosis of asthma were included. Weighted descriptive analysis examined the extent of documentation and uncontrolled asthma; while logistic regression evaluated associated characteristics. Results: Overall, there were 2.47 million (95% confidence interval, 95% CI: 2.04-2.90) average annual visits with asthma as a primary diagnosis. Asthma control and severity was documented in only 36.1% and 33.8% of the visits, respectively. An established patient (odds ratio, OR = 3.81), Hispanic ethnicity (OR = 2.10), chronic sinusitis (OR = 5.59), and visits in the Northeast (OR = 2.12) and Midwest (OR = 2.25) regions had higher odds of documented asthma control status, whereas undocumented asthma severity (OR = 0.02), and visits in spring (OR = 0.34), had lower odds. Osteopathic doctors (OR = 0.18), visits in the Northeast region (OR = 0.23), chronic sinusitis (OR = 0.08), and undocumented asthma control status (OR = 0.03) had lower odds of documented asthma severity, whereas visits in spring (OR = 3.88) and autumn (OR = 3.32) had higher odds. Moderate/severe persistent asthma (OR = 15.35) had higher odds of uncontrolled asthma (as compared to intermittent asthma), while visits in the summer (OR = 0.14) had lower odds. Conclusion: The findings of this study suggest a critical need to increase the documentation of asthma severity and control to improve quality of asthma care in children.

Asthma Medication Prescribing Practices in Pediatric Office Visits.

This cross-sectional study examined how asthma control, demographic, and clinical characteristics are associated with the use of asthma medications in pediatric office visits in the United States. Data from the 2012-2015 National Ambulatory Medical Care Survey included patients aged 6 to 17 years, with asthma as a primary diagnosis (International Classification of Diseases, Ninth Revision, Clinical Modification, code 493.xx). Descriptive weighted analysis evaluated asthma medication use. Multivariable logistic regression examined characteristics associated with asthma prescribing practices. An estimated 2.5 million pediatric office visits were made annually for asthma. The majority of asthma visits involved males (59.3%), children aged 6 to 11 years (54.8%), and whites (73.6%). Several clinical and demographic characteristics contributed to the variations in overall asthma medication use as well as specific drug classes. Lack of documentation of asthma control and uncontrolled asthma were associated with oral corticosteroid and inhaled corticosteroid use in pediatric asthma patients, but not with overall asthma medication use.

Prescribers' perceptions on the impact of hydrocodone rescheduling on geriatric pain management: A qualitative study.

OBJECTIVE: To qualitatively assess prescribers) perceptions regarding the consequences associated with hydrocodone rescheduling among geriatric patients being discharged from inpatient settings. DESIGN: This was a cross-sectional study. SETTING: Two focus groups were conducted by a trained facilitator in a metropolitan academic medical center in January 2016. PARTICIPANTS: Prescribers who manage noncancer pain for geriatric patients were recruited. Focus groups were recorded, transcribed, and then analyzed using ATLAS.ti Qualitative Data Analysis software. Codes were derived from six primary research questions and results were summarized into key themes regarding the impact of rescheduling. MAIN OUTCOME MEASURES: Prescribers) perceptions regarding hydrocodone rescheduling. RESULTS: Prescribers mentioned that they review the prescription monitoring program (PMP) more often before prescribing opioids after rescheduling. They expressed concern regarding the required special serialized prescription forms needed to issue schedule II prescriptions. This led to substituting hydrocodone with potentially less effective pain medications, the inability to issue refills on hydrocodone prescriptions, and an ethical concern over prescribing hydrocodone to patients not under their direct care. Additionally, rescheduling has affected the coordination of care upon discharge, as patients moving to long-term care or skilled nursing facilities may not have adequate pain management when transferred. CONCLUSIONS: The majority of physicians felt rescheduling negatively impacted both practical and ethical aspects of patient care related to pain management after discharge. Rescheduling has changed physicians) hydrocodone prescribing patterns, leading to more caution when prescribing hydrocodone and greater use of the PMP. Future studies should assess geriatric patients) satisfaction and quality of life regarding pain management since hydrocodone was rescheduled.

Atypical antipsychotic prescribing in elderly patients with depression.

BACKGROUND: Atypical antipsychotics are used as monotherapy or as augmentation therapy for management of late-life depression. However, little is known about utilization pattern of atypical antipsychotics in depression in the elderly. OBJECTIVE: The objective of this study was to examine the prescribing practices and predictors of atypical antipsychotics and augmentation therapy in elderly outpatient visits with depression. METHODS: This retrospective cross-sectional study used the National Ambulatory Medical Care Survey (NAMCS) and outpatient department component of the National Hospital Ambulatory Medical Care Survey (NHAMCS) data from 2010 and 2011. The study included elderly (age ≥ 65years) outpatient visits with depression. Descriptive weighted analysis was performed to determine the prescribing practices of atypical antipsychotics and multivariable logistic regression analyses were performed to determine the factors associated with the prescription of atypical antipsychotics and augmentation therapy in outpatient visits. RESULTS: According to the national surveys, there were about 22 million outpatent visits for depression during the study period; atypical antipsychotics were prescribed in 3.53% (95% CI, 2.02-5.04) of the visits. Among depression patients who were using antidepressants, 4.86% (95% CI, 3.07-6.04) used as an augmentation therapy. Multivariable regression analysis revealed that Hispanics (odds ratio [OR] = 0.33; 95% CI, 0.12-0.90) were associated with decreased likelihood of antipsychotic prescription, whereas personality disorder and obsessive compulsive disorder (OR = 10.23; 95% CI, 2.80-37.40) were associated with increased likelihood of prescribing antipsychotics. For augmentation therapy, Hispanics (OR = 0.06; 95% CI, 0.02-0.24) and primary physicians (OR = 0.24; 95% CI, 0.09-0.69) were associated with decreased likelihood; and obsessive compulsive disorder and personality disorder (OR = 7.56; 95% CI, 1.75-32.69) were associated with increased likelihood of antipsychotic prescription. CONCLUSION: Less than 4% of the elderly visits with depression were prescribed atypical antipsychotics. Both clinical and demographic factors contribute to antipsychotic prescribing in elderly patients with depression.