Treatment patterns and outcomes of patients with metastatic non-small cell lung cancer in five European countries: a real-world evidence survey.

BACKGROUND: The landscape of non-small cell lung cancer (NSCLC) therapy is rapidly changing. This analysis aimed to understand patient characteristics, diagnosis and treatment patterns in patients with metastatic NSCLC (mNSCLC) without EGFR and ALK mutations across five European countries. METHODS: Data were drawn from the Adelphi NSCLC Disease Specific Programme™, a point-in-time survey of oncologists/pulmonologists and their consulting patients in France, Germany, Italy, Spain and UK. Physicians completed record forms (RFs) for the next six consecutive consulting patients with advanced NSCLC, who then voluntarily completed questionnaires. As an oversample, physicians provided a further ten RFs specifically for patients with EGFR-wild-type mNSCLC: five patients diagnosed before March 2020 (pre-SARS-CoV-2 [COVID-19]) and five patients diagnosed from March 2020 (during COVID-19). Only EGFR-wild-type/ALK-wild-type patients were included for analysis. RESULTS: Mean (standard deviation [SD]) age for 1073 patients with EGFR-wild-type/ALK-wild-type mNSCLC was 66.2 (8.9) years, 65.2% were male and 63.7% had adenocarcinoma. Level of PD-L1 expression at advanced diagnosis was < 1% for 23.1% of patients, 1-49% for 40.9% and ≥ 50% for 36.0%. Most common first-line (1L) advanced treatment was chemotherapy only (36.9%), immunotherapy monotherapy (30.5%) or immunotherapy + chemotherapy (27.6%). Of 158 patients who had progressed beyond 1L therapy, the mean (SD) time-to-treatment discontinuation was 5.1 (4.3) months; 75.9% of whom completed their 1L treatment as intended. A complete response was achieved by 6.7% and a partial response by 69.2% of patients. Of 38 patients who discontinued 1L treatment early, disease progression was reported for 73.7%. Quality of life (QoL) reported by patients was generally lower than normative reference values. Of 2373 oversample patients, physicians reported management changes for 34.7% due to COVID-19, ranging from 19.6% in Germany to 79.7% in the UK. Immunotherapy was prescribed as 1L NSCLC treatment during COVID-19 for 64.2% (n = 786) of patients and pre-COVID-19, for 47.8% (n = 549). CONCLUSIONS: Real-world treatment patterns suggest that chemotherapy use remains high despite guidelines recommending immunotherapy-based 1L treatment for mNSCLC. QoL reported by patients was generally lower than population reference values. Not implying causality, 1L immunotherapy use was higher during COVID-19 than pre-COVID-19, and the UK saw the biggest impact to patient management due to COVID-19.

Patient Characteristics, Testing and Treatment Patterns, and Outcomes in EGFR-Mutated Advanced Non-Small Cell Lung Cancer: A Multinational, Real-World Study.

INTRODUCTION: Treatment landscape for advanced/metastatic NSCLC (aNSCLC) has evolved considerably over the past few decades with the advent of targeted therapies for epidermal growth factor receptor-mutated (EGFRm+) aNSCLC treatment. This study described real-world patient and disease characteristics, treatment and practice patterns, and clinical, economic, and patient-reported outcomes (PROs) in patients with EGFRm+ aNSCLC. METHODS: Data were derived from the Adelphi NSCLC Disease Specific Programme™ (DSP™), a point-in-time survey conducted between July and December 2020. The survey included oncologists and pulmonologists, and their consulting patients (with physician-confirmed EGFRm+ aNSCLC) from nine countries: the US, Brazil, the UK, Italy, France, Spain, Germany, Japan, and Taiwan. All analyses were descriptive. RESULTS: Overall, 542 physicians reported data for 2857 patients (mean age 65.6 years), and most patients were female (56.0%), white (61.0%), and had stage IV disease at initial diagnosis (76.0%), and adenocarcinoma histology (89.0%). Most patients received EGFR-tyrosine kinase inhibitors (TKI) therapy in first- (91.0%), second- (74.0%), and third-line (67.0%). The most common tumor samples and methods for EGFR detection were EGFR-specific mutation detection tests (44.0%) and core needle biopsy (56.0%). Median time to next treatment was 14.0 (IQR 8.0-22.0) months and disease progression was the main physician-reported reason for early discontinuation. The most common physician-reported disease symptoms were cough (51.0%), fatigue (37.0%), and dyspnea (33.0%). In patients assessed for PROs, mean EQ-5D-5L index and FACT-L health utility scores were 0.71 and 83.5, respectively. On average, patients lost 10.6 h of work/week for approximately 29.2 weeks due to EGFRm+ aNSCLC. CONCLUSION: This real-world multinational data set showed that most patients with EGFRm+ aNSCLC were treated per the country relevant clinical guidelines, with progression as the main reason for early treatment discontinuation. For the included countries, these findings may offer a useful benchmark for decision makers to determine future allocation of healthcare resources for patients with EGFRm+ aNSCLC.

Atypical Treatment Switches in Schizophrenia Patients: Drivers and Associated Outcomes.

Objective: To describe and compare demographics and outcomes among patients with schizophrenia who have switched atypical treatments versus non-switchers. Methods: Data were extracted from the Adelphi Schizophrenia Disease Specific Programme™ conducted from January to May 2014 in the United States. Participating physicians provided information on their next 10 consulting schizophrenia patients aged ≥ 18 years; the same patients were invited to voluntarily complete a patient self-completion form (PSC). Patients were considered switchers (S) or non-switchers (NS) based on their physician-provided treatment history. S were patients who had switched, stopped or added an atypical treatment within the last 2 years. NS had no treatment changes within the last 2 years or were receiving their first-line treatment (for ≥ 3 months). Demographics, clinical characteristics and outcomes among S and NS were compared using both descriptive and multivariate statistics. Results: One-hundred fifty physicians provided data on 1003 patients with schizophrenia (395 S, 608 NS); 500 patients completed a PSC (170 S, 330 NS). When compared with NS, S were more likely to be unemployed (p=0.0060), have a caregiver (p<0.0001), have greater activity impairment as assessed by Work and Productivity Activity Impairment (p=0.0031), be hospitalized for schizophrenia (p<0.0001) and have had a greater mean number of hospitalizations in the last 12 months (p=0.0012). NS vs S were more likely to have much or very much improved illness (p<0.0001) and less severe disease (p<0.0001) as assessed by Clinical Global Impression. Conclusion: Despite switching drugs, some schizophrenia patients continue to have high levels of disease burden, suggesting that currently available therapies are insufficiently effective in these patients.

Patient-psychiatrist discordance and drivers of prescribing long-acting injectable antipsychotics for schizophrenia management in the real-world: a point-in-time survey.

BACKGROUND: To assess discordance between psychiatrists and their patients with schizophrenia regarding disease management and understand drivers of prescribing long-acting injectable (LAI) antipsychotics. METHODS: Data were collected via the Adelphi Schizophrenia Disease Specific Programme™, a point-in-time real-world international survey of psychiatrists and their consulting patients with schizophrenia, conducted in 2019. Psychiatrists completed an attitudinal survey on schizophrenia management and provided patient profiles for their next 10 adult consulting patients. The same patients voluntarily completed patient self-completion forms. Disease severity and improvement were assessed via physician-reported Clinical Global Impression scale; patients' adherence to treatment was rated through a 3-point scale (1=not at all adherent, 3=fully adherent). RESULTS: Four hundred sixty-six psychiatrists provided data for 4345 patients (1132 receiving a LAI; 3105 on non-LAI treatment; 108 not on treatment). LAIs were more commonly prescribed to patients with severe schizophrenia, with varying reasons for prescribing. Globally, only slight agreement was observed between psychiatrists and patients for Clinical Global Impression severity of illness (κ=0.174) and level of improvement on treatment (κ=0.204). There was moderate agreement regarding level of adherence to treatment (κ=0.524). Reasons for non-adherence did not reach a level of agreement greater than fair. CONCLUSIONS: Our real-world survey found that LAIs were more often reserved for severe schizophrenia patients and improving adherence was a key driver for prescribing. However, compared with the patients themselves, psychiatrists tended to underestimate patients' disease severity and overestimate their adherence.

Healthcare resource utilization and quality of life by cognitive impairment in patients with schizophrenia.

OBJECTIVE: The objective was to investigate the association between cognitive impairment and healthcare resource utilization (HCRU) and quality of life (QoL) among patients with schizophrenia. METHODS: Data from the Adelphi Schizophrenia Disease Specific Programme™, a point-in-time survey of physicians and their patients, were collected in the United States between July-October 2019. Psychiatrists reported on patient cognitive function, HCRU, housing circumstances and employment status for their next 10 consulting adult patients with schizophrenia. Patients were classified as having no/mild or moderate/severe cognitive impairment and asked to complete a QoL questionnaire voluntarily. Multiple regression analysis estimated the association between severity of cognitive impairment and patient outcomes adjusting for patient demographics and clinical characteristics. RESULTS: Psychiatrists (n=124) reported on 651 and 484 patients with no/mild and moderate/severe cognitive impairment, respectively. Moderate/severe vs. no/mild cognitive impairment was associated with greater odds of hospitalization related to schizophrenia relapse within the last 12 months (adjusted odds ratio [aOR] [95% CI] = 2.23 [1.53-3.24]) and being unemployed due to disability (aOR = 2.39 [1.65-3.45]). Patients with moderate/severe vs. no/mild cognitive impairment had worse average QoL (EuroQoL 5-dimension [EQ-5D] Health Index: difference = -0.09 [-0.13 to -0.04]; EQ-5D Visual Analogue Scale: difference = -7.0 [-13.0 to -1.0]) and overall life satisfaction (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form: difference = -8.4 [-14.1 to -2.8]). CONCLUSIONS: Moderate/severe cognitive impairment among patients with schizophrenia was associated with worse patient outcomes including greater risk of hospitalizations related to schizophrenia relapse. Treatment to improve cognitive function could benefit the large proportion of patients with schizophrenia who suffer from cognitive impairment.

Point-in-time survey of healthcare resource utilization, employment, quality of life and caregiver status by disease severity in patients with schizophrenia in the US.

OBJECTIVE: The objective of this survey was to assess patient outcomes and caregiver status by disease severity among patients with schizophrenia in the United States. METHODS: A point-in-time survey was conducted between July and October 2019 via the Adelphi Schizophrenia Disease Specific Programme. Psychiatrists reported on their next 10 eligible patients with schizophrenia including demographics, disease severity, treatment history and hospitalizations. Patients receiving treatment for schizophrenia were classified as mild, moderate or severe based on disease severity. Regression models adjusted for age, sex and race/ethnicity. RESULTS: Psychiatrists (n = 124) reported on 435 mild, 401 moderate and 247 severe patients. Greater severity of schizophrenia was associated with a greater number of hospitalizations related to schizophrenia relapse in the previous 12 months (moderate vs. mild: adjusted incidence rate ratio (aIRR) [95% CI] = 2.17 [1.60-2.94]; severe vs. mild: aIRR = 5.45 [3.59-8.27]), lower full-time employment (moderate vs. mild: adjusted odds ratio (aOR) = 0.15 [0.08-0.28]; severe vs. mild: aOR = 0.02 [0.002-0.12]) and greater unemployment due to disability (moderate vs. mild: aOR = 4.24 [3.02-5.97]; severe vs. mild: aOR = 10.85 [6.85-17.17]). Patients with severe vs. mild schizophrenia had lower average quality of life (QoL) measured by the EuroQoL 5-dimension Health Index (difference = -0.16 [-0.23-0.09]). Among patients requiring care, patients with severe vs. mild schizophrenia received more caregiver hours per week (aIRR = 1.89 [1.25-2.84]). CONCLUSIONS: Greater severity of schizophrenia was associated with a significantly greater number of hospitalizations and greater unemployment due to disability. Compared with mild schizophrenia, severe schizophrenia was associated with worse patient QoL and greater caregiver hours.

Associations Between Relapses and Psychosocial Outcomes in Patients With Schizophrenia in Real-World Settings in the United States.

Aim: To assess associations between relapses and psychosocial outcomes in adult patients with schizophrenia treated in United States (US) healthcare settings. Methods: Data were derived from a point-in-time survey of psychiatrists and their patients with schizophrenia conducted across the US, France, Spain, China, and Japan between July and October 2019. For the purposes of this analysis, only data from US practitioners and patients were included. Disease-specific programmes (DSPs) are large surveys with a validated methodology conducted in clinical practise; they describe current disease management, disease burden, and associated treatment effects (clinical and physician-perceived). Participating psychiatrists completed patient record forms for their next 10 consecutive adult consulting patients with schizophrenia, with the same patients invited to voluntarily complete a patient self-completion (PSC) questionnaire. Surveys contained questions on the patients' disease background, treatment history, prior hospitalisation due to schizophrenia relapse and a series of psychosocial outcomes. Associations between relapses in the last 12 months and psychosocial outcomes were examined using multiple regression. Results: A total of 124 psychiatrists provided data on 1,204 patients. Of these, 469 patients (mean age, 39.6 years; 56.5% male) had known hospitalisation history for the last 12 months and completed a PSC; 116 (24.7%) patients had ≥1 relapse. Compared to patients without relapses, patients who relapsed were more likely to be homeless, unemployed, previously incarcerated, and currently have difficulties living independently (all p < 0.05). Patients who experience a relapse also had greater working impairment and poorer quality of life compared with those who did not relapse. In general, psychosocial outcomes became poorer with an increasing number of relapses. Conclusions: In this population of patients with schizophrenia from the US, relapse was significantly associated with poor psychosocial outcomes, with a greater number of relapses predicting worse outcomes. Early intervention to reduce the risk of relapse may improve psychosocial outcomes in patients with schizophrenia.

Treatment Goals in Schizophrenia: A Real-World Survey of Patients, Psychiatrists, and Caregivers in the United States, with an Analysis of Current Treatment (Long-Acting Injectable vs Oral Antipsychotics) and Goal Selection.

PURPOSE: To understand similarities and differences in patient treatment goals as selected by US psychiatrists, adult patients with schizophrenia, and their caregivers in a real-world setting in the United States, including stratification by current medication and age. PATIENTS AND METHODS: Data were drawn from the Adelphi Schizophrenia Disease Specific Programme™, a point-in-time survey of psychiatrists and their consulting adult patients with schizophrenia, conducted from June to October 2019. Psychiatrists completed record forms for their next 8 consecutive outpatients and (where possible) 2 inpatients matching inclusion criteria. Participating psychiatrists, patients, and caregivers completed treatment goal questionnaires as part of the survey. RESULTS: Psychiatrists (n = 124) provided data on 1204 patients with schizophrenia, including 1135 on drug treatment (207 inpatients [18%] and 928 outpatients [82%]); questionnaires were completed by 555 patients and 135 caregivers. Decrease in disease symptoms was identified as the most important patient treatment goal by patients (64%), psychiatrists (selecting for 63% of patients), and caregivers (selecting for 68% of patients). Patients, psychiatrists, and caregivers similarly rated the least important goals (less sexual problems and less weight gain). Patients indicated their current medication helped to reach their most important goals: decrease in disease symptoms (68%) and thinking more clearly (39%). Findings based on analysis of treatment goals by treatment and age were similar to overall trends. CONCLUSION: These findings, including identification of a primary consensus goal of decrease in disease symptoms, may help with discussions between patients with schizophrenia, psychiatrists, and caregivers to inform effective management strategies and encourage shared decision-making.

Real-World Treatment Patterns and Outcomes in Patients with Head and Neck Cancer: Point-in-Time Survey of Oncologists in Italy and Spain.

INTRODUCTION: Squamous cell carcinomas of the head and neck (SCCHN) account for approximately 4% of all malignancies and are associated with high morbidity and poor prognosis. For patients who are not eligible for surgery or radiotherapy, treatment options are limited, especially for those with recurrent or metastatic (R/M) disease. Current European guidelines recommend first-line (1L) treatment with palliative chemotherapy, using biologic or platinum-based regimens. In the absence of new clinical trials in SCCHN, the use of real-world data has facilitated the assessment of treatment patterns and outcomes in different healthcare systems. This study reports on the 1L treatment of platinum-eligible patients with R/M SCCHN in Italy and Spain. METHODS: A point-in-time survey of the management of patients with R/M SCCHN was completed by clinical oncologists in Italy and Spain between October 2018 and February 2019. Patient demographics and clinical characteristics were obtained by retrospective chart review, whilst participating patients self-reported the impact of their disease on their quality of life (QoL) and well-being. RESULTS: A total of 436 patients were recruited from Italy (216) and Spain (220). Patient demographics for both countries comprised mostly male patients, aged 65 years in Italy and 63 in Spain on average. The primary site for the SCCHN was the pharynx and 36% of patients had metastatic disease overall. EXTREME or cetuximab-based regimens were the most common treatments administered at 1L (52% in Italy and 78% in Spain). Scores on the FACT-G in both countries were substantially lower than those of the general and other advanced cancer populations, while scores on the EQ-5D were clinically meaningfully lower than local population norms. CONCLUSION: Despite 1L treatment of platinum-eligible patients with R/M SCCHN in Italy and Spain following current European guidelines, patients' QoL remains poor, which highlights the need for alternative treatments that could improve clinical outcomes.

Characterizing the role of, and physical and emotional burden on caregivers of patients with heart failure: Results from a cross-sectional survey in Japan.

The aim of this cross-sectional survey was to characterize the role of and burden on caregivers of heart failure (HF) patients in Japan, since such data are limited at present. Data from 126 caregivers whose average age was 63.5 years were analyzed. Helping to prepare meals/cooking was the most frequently reported activity (47% of caregivers); 24% found this the most burdensome. The most frequently reported physical consequence of caregiving was feeling physically tired (44%); emotionally worrying about the patient (62%) was the most frequent psychological consequence. Approximately half of the caregivers reported that caring for patients impacted their lifestyle. Although 40% of caregivers asked questions to physicians regarding diet or lifestyle modifications, 19% did not ask any. Caregivers play a crucial role in the management of HF patients in Japan but experience physical and emotional burden. Solutions are required to reduce the caregiver burden associated with HF.

A Real-World Assessment of Outcomes in Schizophrenia Patients According to Treatment Response.

OBJECTIVE: To describe and compare demographics, outcomes, and comorbidities among schizophrenia patients according to treatment response. METHODS: A cross-sectional survey was conducted in the United States through the Adelphi Schizophrenia Disease Specific Program from January to May 2014. Participating physicians provided information on the first 10 schizophrenia patients aged ≥ 18 years they saw in daily clinical practice; these patients were invited to voluntarily complete a patient self-completion form. Patients were considered partial responders or responders based on the physician-reported Clinical Global Impressions improvement scale. Regression analyses were performed to identify potential drivers of response and the clinical and humanistic outcomes associated with response. RESULTS: 150 physicians provided data on 433 partial responders and 872 responders; 185 partial responders and 415 responders completed a patient self-completion form. A significant predictor of response was always being adherent with the medication regimen (P < .001). Positive symptoms (P = .006) and moderate (P = .004) or severe (P = .002) illness severity were significant predictors of inadequate response. Responders were more likely to have better EQ-5D (EuroQol 5 Dimensions) visual analog scale, Quality of Life Enjoyment and Satisfaction Questionnaire, and work productivity and impairment scores (all P < .05). CONCLUSIONS: Partial responders were more likely to have significantly poorer clinical and quality of life outcomes compared with responders. Improved therapeutic approaches, either new therapies or optimized treatments, could lead to both better outcomes and improved adherence in this population.

Assessment of Real-Life Outcomes in Schizophrenia Patients according to Compliance.

OBJECTIVE: To describe and compare demographics, outcomes and comorbidities in schizophrenia patients by treatment compliance. METHODS: This was a cross-sectional survey of hospital- or office-based psychiatrists who saw ≥6 schizophrenia patients per week and were responsible for treatment decisions. Recruited physicians completed a patient record form (PRF) for their first 10 consulted schizophrenia patients aged ≥18. These patients voluntarily completed a patient self-completion form (PSC). Compliance was measured by subjective physician assessment. Drivers of and outcomes associated with compliance were identified by regression analyses. RESULTS: A total of 150 physicians completed PRFs for 1489 patients (706 sometimes compliant (SC), 636 always compliant (AC)). A total of 680 patients completed a PSC (327 SC, 295 AC). AC patients were less likely to be male (52.2% vs. 58.6%; P = 0.021) and unemployed (odds ratio (OR) 0.91, 95% confidence interval (CI) 0.82-1.00; P < 0.001) or to have had a treatment regimen change (OR 0.56, 95% CI 0.40-0.80; P = 0.001) than SC patients. AC patients were less likely to have had more comorbidities (OR 0.91, 95% CI 0.82-1.00; P = 0.045) and hospitalizations in the past 12 months (OR 0.59, 95% CI 0.43-0.80; P = 0.001) than SC patients. Overall, AC patients had better clinical and humanistic outcomes. Weight gain was a common side effect for all patients; SC patients with weight gain had poorer outcomes than those without weight gain. CONCLUSION: Schizophrenia patients that were SC experienced poorer clinical outcomes and quality of life. Weight gain may exacerbate these poorer outcomes.

Burden of Heart Failure on Patient Daily Life and Patient-Physician Discordance in Disease Management　- Results From a Cross-Sectional Survey in Japan.

Background: We investigated the impact of heart failure (HF) on daily life and satisfaction with current HF medication from the patient perspective in a real-world study in Japan. Methods and Results: A cross-sectional survey of 154 HF patients treated by 58 cardiologists was conducted in Japan using patient self-completed questionnaires about their daily life and satisfaction with HF medication, as well as patient record forms completed by their physicians capturing corresponding data. The mean age of patients was 72.7 years. The proportion of patients within New York Heart Association Class I, II, III, and IV was 39%, 44%, 16%, and 1%, respectively. Symptoms reported by patients included dyspnea when active (46%), nocturia (43%), anxiety (18%), and depression (6%). There was a discordance between physician- and patient-reported symptoms, especially for nocturia and inability to sleep. The most frequent lifestyle recommendation from physicians was 'reduce salt/sodium intake', but only 51% of patients receiving this recommendation followed the advice. In all, 44% of patients reported dissatisfaction with their current medication; according to the patients, 27% reported no discussion with their physicians about their prescribed medication, while physicians reported the opposite. Conclusions: HF negatively impacts patient daily life. There is discordance between patients and physicians in symptom reporting, lifestyle modification advice and adherence, and reported medication decision making. Gaps in patient-physician communication exist.

Characteristics of patients with dyslipidemia treated in routine care setting in China.

Objective: To describe characteristics of patients with dyslipidemia treated in routine care in China overall and stratified by diabetes and atherosclerotic cardiovascular disease (ASCVD). Methods: This study used data from a cross-sectional survey conducted in China in 2017 under the Dyslipidemia Disease Specific Programme (DSP). Each surveyed physician provided information including demographics, dyslipidemia diagnosis and treatment history, lab values on at least 8 patients currently treated for dyslipidemia with oversampling of patients with ASCVD or diabetes mellitus diagnosis at the time of survey. A related patient survey assessed treatment adherence and satisfaction. Results: This study included 195 physicians (40 endocrinologists, 75 internists, 80 cardiologists) who provided data on 1870 patients (852 with diabetes; 1018 patients without diabetes). Among patients with diabetes, 279 had ASCVD and 573 did not (non-ASCVD). In the diabetic population, patients with ASCVD were older (67.3 vs. 62.1 years), more often had caregiver support (34 vs. 14%), and had higher average LDL-C at diagnosis (172.4 vs. 167.4 mg/dL) compared to their non-ASCVD counterparts. Findings were similar for non-diabetic patients (ASCVD: 323 patients; non-ASCVD: 695) patients. In all four subgroups, 46-54% of patients reported low treatment adherence, and fewer than half expressed satisfaction with their cholesterol control, and 2-5% had LDL-C < 70 mg/dL at their most recent assessment. Conclusions: Among patients with dyslipidemia, those with ASCVD had higher LDL-C levels than patients without ASCVD, and many required caregiving. Low levels of treatment adherence, LDL-C control, and patient satisfaction suggest opportunities to improve care for Chinese patients with dyslipidemia.

Real-world treatment patterns of PCSK9 inhibitors among patients with dyslipidemia in Germany, Spain, and the United Kingdom.

OBJECTIVE: Proprotein convertase subtilisin/kexin type 9 antibody inhibitors (PCSK9i) are approved as adjuncts to maximal tolerated statin therapy to lower low-density lipoprotein cholesterol (LDL-C). This study describes real-world use, characteristics of PCSK9i users and non-users, and factors influencing treatment choice. METHODS: A physician and patient survey was conducted in Germany, Spain, and the UK from December 2016 to April 2017 through the Adelphi Dyslipidemia Disease Specific Program. Physicians reported patients' lipid-lowering therapy (LLT) history and characteristics. PCSK9i users were systematically over-sampled. Results were summarized using frequencies and proportions. RESULTS: The study included 110, 123, and 117 physicians from Germany, Spain, and the UK, respectively, providing data on 3,073 patients (mean age = 62 years; 60% male). Most patients (63-73%) had prior statin and/or ezetimibe use. Compared to patients receiving other LLT (n = 2686), PCSK9i users (222 in Germany, 97 in Spain, 68 in the UK) were, on average, 5-7.5 years younger and had LDL-C at diagnosis averaging 23-53 mg/dl higher. Familial hypercholesterolemia (FH), coronary heart/artery disease, myocardial infarction, and acute coronary syndrome were more common among PCSK9i users than non-users. PCSK9i users were also more likely to use high-intensity statins in their current LLT regimen (64-89% vs 28-50%). Physicians commonly reported PCSK9i benefits on LDL-C and total cholesterol as reasons for initiating these agents, and PCSK9i users reported good knowledge of cardiovascular disease and treatment options. CONCLUSIONS: Results indicate that physicians are prescribing PCSK9i to patients with high cardiovascular risk in accordance with European guidelines and reimbursement requirements.

A preliminary audit of medical and aid provision in English Rugby union clubs: compliance with Regulation 9.

BACKGROUND: Governing bodies are largely responsible for the monitoring and management of risks associated with a safe playing environment, yet adherence to regulations is currently unknown. The aim of this study was to investigate and evaluate the current status of medical personnel, facilities, and equipment in Rugby Union clubs at regional level in England. METHODS: A nationwide cross-sectional survey of 242 registered clubs was undertaken, where clubs were surveyed online on their current medical personnel, facilities, and equipment provision, according to regulation 9 of the Rugby Football Union (RFU). RESULTS: Overall, 91 (45. 04%) surveys were returned from the successfully contacted recipients. Of the completed responses, only 23.61% (n = 17) were found to be compliant with regulations. Furthermore, 30.56% (n = 22) of clubs were unsure if their medical personnel had required qualifications; thus, compliance could not be determined. There was a significant correlation (p = -0.029, r = 0.295) between club level and numbers of practitioners. There was no significant correlation indicated between the number of practitioners/number of teams and number of practitioners/number of players. There were significant correlations found between club level and equipment score (p = 0.003, r = -0.410), club level and automated external defibrillator (AED) access (p = 0.002, r = -0.352) and practitioner level and AED access (p = 0.0001, r = 0.404). Follow-up, thematic analysis highlighted widespread club concern around funding/cost, awareness, availability of practitioners and AED training. CONCLUSION: The proportion of clubs not adhering overall compliance with Regulation 9 of the RFU is concerning for player welfare, and an overhaul, nationally, is required.

Perceptions of heart failure symptoms, disease severity, treatment decision-making, and side effects by patients and cardiologists: a multinational survey in a cardiology setting.

PURPOSE: Explore the extent to which heart failure (HF) symptoms and side effects of HF treatment experienced by patients are recognized by cardiologists, and concordance between patient-cardiologist perceptions of HF severity and patients' contributions to treatment decision-making. METHODS: A multinational, cross-sectional survey of cardiologists and patients with HF was conducted. Patient-record forms (PRFs) were completed by cardiologists for consecutive consulting patients with HF, who completed a patient self-completion questionnaire (PSC). Responses from PRFs with an associated PSC were analyzed to compare patient- and cardiologist-reported occurrences of HF symptoms and treatment side effects, patient-perceived severity of HF and cardiologists' perceived risk of death within 12 months, and patient input into treatment decisions. Concordance was calculated as the number of response agreements between PSCs and PRFs for total number of matched pairs. Over- or underreporting of symptoms and side effects by cardiologists relative to patient-reported occurrences were calculated. RESULTS: Overall, 2,454 patient-cardiologist pairs were identified. High levels of concordance between matched pairs were observed for the occurrence of reported HF symptoms (93%), side effects (77%-98%) and degree of patient input into treatment decisions (74%); for perceived HF severity, concordance was 54%. Most symptoms (except dyspnea when active and fatigue/weakness, experienced by >50% of patients) were underreported by cardiologists. Of patients reporting to have been informed by their cardiologist that their HF was mild, 28% were perceived by their cardiologist to have a moderate-high/very high risk of death within 12 months. Treatment choice was not discussed with almost a third of patients. When discussed, 94% of patients (n=1,540) reported the cardiologist made the final decision. Cardiologists more often under- than overreported the occurrence of side effects reported by patients. CONCLUSION: Improved patient-cardiologist dialogue and shared decision-making is required for optimizing patient care and outcomes in HF.

Patient Characteristics and Real-World Treatment Patterns Among Early Users of PCSK9 Inhibitors.

BACKGROUND: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) reduce low-density lipoprotein cholesterol (LDL-C) levels and are approved for patients with familial hypercholesterolemia or atherosclerotic cardiovascular disease who require additional LDL-C lowering. OBJECTIVE: Our objective was to characterize patients receiving PCSK9i medications in real-world practice and describe physician-reported treatment patterns among dyslipidemia patients using PCSK9i or other lipid-lowering therapy. METHODS: We analyzed data from a point-in-time Adelphi dyslipidemia disease-specific programme (DSP) survey conducted in the USA in 2016. Physicians provided treatment history, laboratory values, patient characteristics, and comorbidities for treated patients. To ensure sufficient numbers of PCSK9i-treated patients, we conducted systematic oversampling of patients being prescribed PCSK9i. Outcomes included patient characteristics and physician-reported treatment patterns. RESULTS: The DSP included 159 physicians, who provided information on 1522 patients (304 PCSK9i; 1218 non-PCSK9i). Mean ± standard deviation (SD) baseline LDL-C levels were 180.0 ± 39.7 mg/dl for PCSK9i patients and 159.2 ± 40.5 mg/dl for non-PCSK9i patients. Prior statin use was reported in 69.1% of PCSK9i patients and 19.5% of non-PCSK9i patients, and physician-reported statin intolerance was observed in 31.6% of PCSK9i and 5.3% of non-PCSK9i patients. Use of statins only was reported in 40.5% of PCSK9i and 88.8% of non-PCSK9i patients. The most common physician-reported reasons for change to PCSK9i were lack of efficacy (70.2%) and muscle-related symptoms (myalgia 28.6%; myopathy 11.1%). CONCLUSIONS: Physicians surveyed appeared to prescribe PCSK9i medications appropriately. PCSK9i-treated patients had higher rates of cardiovascular comorbidities and physician-determined statin intolerance, had higher LDL-C levels, and received more lines of therapy than non-PCSK9i patients.