Quality Assessment of Online Resources for the Most Common Cancers.

The internet is a common source of health information for patients with cancer. Despite research surrounding the quality of online resources for individual types of cancer, these results may not necessarily be easily extrapolated to cancer resources as a whole. Thus, we aim to use a standardized tool to produce generalizable results by analyzing the quality of online resources for the most common cancers. Educational websites pertaining to breast, lung, prostate, and colorectal cancers were searched using multiple search engines. After screening against pre-specified inclusion criteria, the most visible 100 websites for each cancer were extracted for analysis. A validated tool was then used to assess their quality. Pooled results were evaluated using descriptive and inferential statistics. Of the 400 analyzed websites, 43% were commercially affiliated, and these were significantly associated with greater use of biased language. Thirty percent of websites disclosed authorship, 47% cited at least one reliable source, and 43% were updated within the last 2 years. The average Flesch-Kincaid readability was determined to be at a grade 10.9 level, which is significantly more difficult than the recommended grade 6 level. Risk factors, symptoms, and detection were the most accurately covered topics. However, most websites did not cover prognosis. This study comprehensively examines the quality of online cancer resources for the four most common cancers. Our results could help guide the development of future resources, support patient education endeavors, and raise awareness among healthcare providers about the limitations of online cancer resources.

An International Multicenter Real-Life Prospective Study of Electronic Chromoendoscopy Score PICaSSO in Ulcerative Colitis.

BACKGROUND & AIMS: Endoscopic and histologic remission are important goals in the treatment of ulcerative colitis (UC). We investigated the correlation of the recently developed Paddington International Virtual ChromoendoScopy ScOre (PICaSSO) and other established endoscopic scores against multiple histological indices and prospectively assessed outcomes. METHODS: In this prospective multicenter international study, inflammatory activity was assessed with high-definition and virtual chromoendoscopy in the rectum and sigmoid using the Mayo Endoscopic Score (MES), UC Endoscopic Index of Severity (UCEIS), and PICaSSO. Targeted biopsies were taken for assessment using Robarts Histological Index (RHI), Nancy Histological index (NHI), ECAP (Extent, Chronicity, Activity, Plus score), Geboes, and Villanacci. Follow-up data were obtained at 6 and 12 months after colonoscopy. RESULTS: A total of 307 patients were recruited. There was strong correlation between PICaSSO and histology scores, significantly superior to correlation coefficients of MES and UCEIS with histology scores. A PICaSSO score of ≤3 detected histologic remission by RHI (≤3 + absence of neutrophils) with area under the receiver operating characteristic curve (AUROC) 0.90 (95% confidence interval [CI] 0.86-0.94) and NHI (≤1) AUROC 0.82 (95% CI 0.77-0.87). The interobserver agreement for PICaSSO was 0.88 (95% CI 0.83-0.92). At 6- and 12-months follow-up, PICaSSO score ≤3 predicted better outcomes than PICaSSO >3 (hazard ratio [HR] 0.19 [0.11-0.33] and 0.22 [0.13-0.34], respectively),} as well as PICaSSO 4-8 (HR 0.25 [0.12-0.53] and 0.22 (0.12-0.39), respectively) and similar to histologic remission. CONCLUSION: In this first real-life multicenter study, the PICaSSO score correlated strongly with multiple histological indices. Furthermore, PICaSSO score predicted specified clinical outcomes at 6 and 12 months, similar to histology. Thus, PICaSSO can be a useful endoscopic tool in the therapeutic management of UC.

Quality Analysis of Online Patient Resources for Hepatocellular Carcinoma.

GOAL: This study aims to evaluate the quality of online hepatocellular carcinoma (primary liver cancer) resources by using a validated tool to determine the strengths and limitations of hepatocellular carcinoma Web sites designed for patient education. BACKGROUND: In recent years, online health information-seeking behavior has become more prevalent. Meanwhile, hepatocellular carcinoma incidence rates have also increased. However, there is currently limited literature assessing the quality of online hepatocellular carcinoma information. MATERIALS AND METHODS: The term "hepatocellular carcinoma" was searched using the search engine Google and the meta-search engines Dogpile and Yippy. A validated rating tool was used to assign quality scores to 100 Web sites based on the domains of Web site affiliation, accountability, interactivity, structure and organization, readability, and content quality. Overall quality scores were tallied for all Web sites. RESULTS: Noncommercial hepatocellular carcinoma Web sites received significantly higher overall quality scores compared with their commercial counterparts. Overall, 30% of the Web sites identified their author(s), 42% cited sources, and 33% were updated within the past 2 years. The majority of Web sites utilized at least 1 interactive feature and 4 structural tools. Average readability was at a grade 11.8 level using the Flesch-Kincaid grading system, which is significantly higher than the recommended grade 6 level. Definition and treatment were the most commonly covered topics, while prevention and prognosis were the least commonly covered. CONCLUSIONS: The quality of online hepatocellular carcinoma information is highly variable. Health care professionals should be aware of its limitations and be proactive in guiding patients to reliable resources.

Prevalence, Comorbidities, and Risk Factors of Erectile Dysfunction: Results from a Prospective Real-World Study in the United Kingdom.

Objectives: Assessment of erectile dysfunction (ED) burden could improve health outcomes associated with underlying cardiometabolic and psychological causes of ED. This study provided updated real-world evidence (RWE) on ED epidemiology and quantified healthcare resource utilization (HCRU) and health-related quality of life (HRQoL) burden among men with ED in the UK. Methods: This cross-sectional, prospective real-world evidence study was conducted via a self-reported Internet survey in 2018 in the UK general population. Prevalence of ED was estimated; HCRU and HRQoL were compared between men with ED versus without ED via bivariate analysis. Results: Of 12,490 men included, 41.5% reported ED; 7.5% of men reported severe ED; ED was most prevalent in Wales (44.3%). Men with ED were older (54.1 ± 14.5 vs. 46.8 ± 14.1 years) and often reported modifiable lifestyle risk factors, including smoking (32.8% vs. 26.3%), drinking alcohol (76.1% vs. 71.0%), not exercising (21.7% vs. 19.4%), and being overweight or obese (64.9% vs. 54.6%). Additionally, men with ED more often reported ≥1 comorbid chronic conditions (73.7% vs. 47.7%), including hypertension (31.8% vs. 16.3%), hyperlipidemia (27.6% vs. 14.0%), depression (24.3% vs. 14.6%), anxiety (23.3% vs. 16.6%), and diabetes (15.9% vs. 6.1%) versus men without ED (all, p < 0.001). Nearly half of men with ED (45.3%) were not undergoing treatment for cardiometabolic or psychological comorbidities. Furthermore, men with ED more often reported ≥1 visit to physicians/nurse practitioners and pharmacists in the past year and had significantly lower SEAR total and domain scores than men without ED (all, p < 0.001). Conclusion: ED was highly prevalent in the UK affecting over a quarter of younger men. Cardiometabolic and psychological conditions were common among men with ED and often remained untreated. Higher proportions of modifiable lifestyle risk factors observed among men with ED present an opportunity for healthcare providers to help mitigate the risk of cardiometabolic diseases and incidence of ED.

Increasing access to erectile dysfunction treatment via pharmacies to improve healthcare provider visits and quality of life: Results from a prospective real-world observational study in the United Kingdom.

OBJECTIVES: The Medicines and Healthcare Products Regulatory Agency in the United Kingdom (UK) formally reclassified sildenafil citrate 50 mg tablets as a pharmacy medicine (sildenafil-P) in 2017 for adult men with erectile dysfunction (ED). A 1-year prospective real-world observational study was conducted to track men's health behaviour, particularly their healthcare resource utilisation (HCRU) and quality of life (QoL) before and after the availability of sildenafil-P. METHODS: Adult men with ED aged ≥18 years provided data at baseline (prior to launch of sildenafil-P) and every 3 months after the launch. Demographics, health characteristics, treatments at baseline and HCRU, including number of pharmacist and physician/nurse practitioner visits over time are reported. QoL-related outcomes were assessed via the Self-Esteem and Relationship Questionnaire (SEAR), 2-Item Patient Health Questionnaire and ratings of sexual satisfaction. Generalised linear models were used to assess the association of sildenafil-P use with total physician/nurse practitioner and pharmacist visits and QoL-related outcomes at 12 months. RESULTS: Overall, 1162 men completed the survey at all 5 time points. The mean ± SD age was 59.02 ± 12.06 years; 55.42% reported having a moderate-to-severe ED. Hypertension (37.52%) and hypercholesterolaemia (31.50%) were the most common risk factors for ED. At baseline, 62.99% were not using any ED treatment. After adjusting for baseline visits/other covariates, mean physician/nurse practitioner (3.68 vs 2.87; P = .003) and pharmacist visits for any reason (2.10 vs 1.34; P < .001) at 12 months were significantly higher among sildenafil-P users than those who never used sildenafil-P. Sildenafil-P users also had significantly higher SEAR total and domain (sexual relationship and self-esteem) scores at 12 months. CONCLUSION: Following the reclassification to a pharmacy medicine in the UK, sildenafil-P was associated with a higher number of physician/nurse practitioner and pharmacist visits for any reason. Sildenafil-P use was also associated with better QoL, although group differences were small in magnitude.

Impact of sertraline daily treatment regimen on adherence, persistence and healthcare resource utilisation in patients with major depressive disorder or obsessive-compulsive disorder: A real-world evidence analysis from the United States.

OBJECTIVE: To generate real-world evidence (RWE) from the United States to assess the impact of pill burden and the importance of achieving a stable daily dose of sertraline (time taken, number of dose adjustments needed) on adherence/persistence and healthcare resource utilisation (HCRU). METHODS: Retrospective analysis of the PharMetrics® Plus database (1 October 2012 to 31 March 2020) in the United States. Eligible patients had major depressive disorder (MDD) or obsessive-compulsive disorder (OCD) and ≥1 claim for sertraline during index period (1 April 2013 to 31 March 2019, allowing 6-months prior, 1-year post-index follow-up). Patients who achieved stable daily dose of sertraline (>90 days on same dose) were categorised into five cohorts, depending on pill burden/daily dose: Cohort (1): 1 × 50 mg/d; Cohort (2): 1 × 100 mg/d; Cohort (3): 2 × 50 mg/d; Cohort (4): 1.5 × 100 mg/d; Cohort (5): 3 × 50 mg/d. Impact of pill burden on adherence/persistence and HCRU was assessed among cohorts using logistic regression analysis, and between patients who did vs did not stabilise on therapy. P < .05 was considered significant for all analyses. RESULTS: Of 224 412 eligible patients, 108 729 stabilised on sertraline (50, 100 or 150 mg/d) and formed Cohorts 1-5. Stabilised patients on lower pill burden had statistically higher adherence and were more likely to remain persistent throughout 1-year post-index period vs patients on higher pill burden but same overall dose (100 mg/d [Cohort 2 vs 3] and 150 mg/d [Cohort 4 vs 5], respectively). Patients who did not stabilise had significantly lower adherence/persistence vs patients who achieved stable daily dose (Cohorts 1-5 combined). Persistence improved when stable daily dose was achieved quickly (within 1-4 months) and efficiently (within 1-3 dose adjustments). Probability of HCRU increased for patients who did not stabilise on their initial prescription. CONCLUSION: Simplifying treatment regimen and decreasing pill burden improved adherence and/or persistence with sertraline therapy (100 or 150 mg/d). Patients achieving stable daily dose of sertraline in an efficient and timely manner were more likely to remain persistent throughout 1-year follow-up.

Long-term statin adherence in patients after hospital discharge for new onset of atherosclerotic cardiovascular disease: a population-based study of real world prescriptions in Taiwan.

BACKGROUND: Despite the recommendations of statins treatment for secondary prevention of atherosclerotic cardiovascular disease (ASCVD), treatment adherence and persistence are still a concern. This study examined the real world practice of long-term adherence and persistence to statins treatment initiated after hospital discharge for ASCVD, and their associated factors in a nationwide cohort. METHODS: Post discharge statin prescriptions between 2006 and 2012 were extracted from the Taiwan National Health Insurance claims database. Good adherence, defined as proportion of days covered (PDC) ≥0.8 and mean medication possession ratio (MPR), was measured every 180-day period. Non-persistence was defined on the date patients failed to refill statin for 90 days after the end of the last prescription. Their associations with influential factors were analyzed using a generalized estimating equation and Cox's proportional hazard model. RESULTS: There was a total of 185,252 post-discharge statin initiations (from 169,624 patients) and followed for 467,398 patient-years in the study cohort. Percentage of good adherence (mean MPR) was 71% (0.87) at 6-months; declined to 54% (0.68), 47% (0.59), and 42% (0.50) at end of year 1, 2, and 7, respectively. Persistence in statin treatment was 86, 67, 50, and 25% at 6-month, 1-, 2-, and 7-year, respectively. Comparing the statin-cohort initiated from year 2006 to 2012, 1-year persistence increased from 58 to 73%, and 1-year good adherence improved from 45 to 61%. Factors associated with sub-optimal adherence and non-persistence included: prescription by primary care clinics or non-cardiology specialties; patients' age > 75 years; no history of previous statin use; ASCVD events with ischemic stroke diagnosis; comorbidities of renal disease, liver disease, depression, and chronic obstructive pulmonary disease. CONCLUSIONS: Despite the improving trends, long-term adherence and persistence of statin treatment were suboptimal in Taiwan. Strategies to maintain statin treatment adherence and persistence need to be implemented to further enhance the positive trend.

Estimating the future burden of cardiovascular disease and the value of lipid and blood pressure control therapies in China.

BACKGROUND: Lifestyle and dietary changes reflect an ongoing epidemiological transition in China, with cardiovascular disease (CVD) playing an ever-increasing role in China's disease burden. This study assessed the burden of CVD and the potential value of lipid and blood pressure control strategies in China. METHODS: We estimated the likely burden of CVD between 2016 and 2030 and how expanded use of lipid lowering and blood pressure control medication would impact that burden in the next 15 years. Accounting for the costs of drug use, we assessed the net social value of a policy that expands the utilization of lipid and blood pressure lowering therapies in China. RESULTS: Rises in prevalence of CVD risk and population aging would likely increase the incidence of acute myocardial infarctions (AMIs) by 75 million and strokes by 118 million, while the number of CVD deaths would rise by 39 million in total between 2016 and 2030. Universal treatment of hypertension and dyslipidemia patients with lipid and blood pressure lowering therapies could avert between 10 and 20 million AMIs, between 8 and 30 million strokes, and between 3 and 10 million CVD deaths during the 2016-2030 period, producing a positive social value net of health care costs as high as $932 billion. CONCLUSIONS: In light of its aging population and epidemiological transition, China faces near-certain increases in CVD morbidity and mortality. Preventative measures such as effective lipid and blood pressure management may reduce CVD burden substantially and provide large social value. While the Chinese government is implementing more systematic approaches to health care delivery, prevention of CVD should be high on the agenda.

Influence of real-world characteristics on outcomes for patients with methicillin-resistant Staphylococcal skin and soft tissue infections: a multi-country medical chart review in Europe.

BACKGROUND: Patient-related (demographic/disease) and treatment-related (drug/clinician/hospital) characteristics were evaluated as potential predictors of healthcare resource use and opportunities for early switch (ES) from intravenous (IV)-to-oral methicillin-resistant Staphylococcus aureus (MRSA)-active antibiotic therapy and early hospital discharge (ED). METHODS: This retrospective observational medical chart study analyzed patients (across 12 European countries) with microbiologically confirmed MRSA complicated skin and soft tissue infections (cSSTI), ≥3 days of IV anti-MRSA antibiotics during hospitalization (July 1, 2010-June 30, 2011), and discharged alive by July 31, 2011. Logistic/linear regression models evaluated characteristics potentially associated with actual resource use (length of IV therapy, length of hospital stay [LOS], IV-to-oral antibiotic switch), and ES and ED (using literature-based and expert-verified criteria) outcomes. RESULTS: 1542 patients (mean ± SD age 60.8 ± 16.5 years; 61.5% males) were assessed with 81.0% hospitalized for MRSA cSSTI as the primary reason. Several patient demographic, infection, complication, treatment, and hospital characteristics were predictive of length of IV therapy, LOS, IV-to-oral antibiotic switch, or ES and ED opportunities. Outcomes and ES and ED opportunities varied across countries. Length of IV therapy and LOS (r = 0.66, p < 0.0001) and eligibilities for ES and ED (r = 0.44, p < 0.0001) showed relatively strong correlations. IV-to-oral antibiotic switch patients had significantly shorter length of IV therapy (-5.19 days, p < 0.001) and non-significantly shorter LOS (-1.86 days, p > 0.05). Certain patient and treatment characteristics were associated with increased odds of ES (healthcare-associated/ hospital-acquired infection) and ED (patient living arrangements, healthcare-associated/ hospital-acquired infection, initiating MRSA-active treatment 1-2 days post cSSTI index date, existing ED protocol), while other factors decreased the odds of ES (no documented MRSA culture, ≥4 days from admission to cSSTI index date, IV-to-oral switch, IV line infection) and ED (dementia, no documented MRSA culture, initiating MRSA-active treatment ≥3 days post cSSTI index date, existing ES protocol). CONCLUSIONS: Practice patterns and opportunity for further ES and ED were affected by several infection, treatment, hospital, and geographical characteristics, which should be considered in identifying ES and ED opportunities and designing interventions for MRSA cSSTI to reduce IV days and LOS while maintaining the quality of care.

Non-recurrent laryngeal nerve injury associated with an aberrant right subclavian artery: a case report.

Background: Injury to the recurrent laryngeal nerve (RLN) is a recognised complication of surgery in the neck. The presence of a non-recurrent laryngeal nerve (NRLN) significantly increases the risks of a nerve injury. Given that NRLNs are strongly associated with vascular abnormalities that can be visualised on preoperative imaging, we describe a case to raise awareness of this association with the aim of reducing the risk of iatrogenic nerve injury. Case Description: A 61-year-old gentleman was referred by his family doctor with a history of radiating left arm pain and paraesthesia consistent with C6 +/- C7 radiculopathy. The patient failed conservative management, and elected to undergo an anterior cervical discectomy and fusion procedure. Preoperative magnetic resonance imaging (MRI) showed an incidental finding of an aberrant right subclavian artery (ARSA) following a retro-oesophageal path. Surgery was performed with a right sided cervical approach without intraoperative complications; however, the patient had marked dysphonia post-operatively. Assessment by otorhinolaryngology (ORL) concluded that this was most likely secondary to a right NRLN palsy. The patient underwent a vocal fold injection laryngoplasty for temporary vocal fold augmentation, and the voice subsequently recovered and remained asymptomatic at 1-year post-procedure. Conclusions: This case demonstrated that identification of vascular anomalies associated with NRLNs on preoperative imaging should prompt a left sided cervical approach to avoid a nerve injury during surgery.

A Web-Based Survey of Patients Dispensed Viagra Connect® Behind the Counter in UK: An Evaluation of Effectiveness of Additional Risk Minimization Measures.

Purpose: A national additional risk minimization measures (aRMMs) program was implemented to train pharmacists for safe supply of non-prescription Viagra Connect® (VC) to erectile dysfunction (ED) patients in United Kingdom (UK). A survey aimed to evaluate the effectiveness of aRMMs. Methods: A cross-sectional, web-based survey enrolled ED patients who purchased at least 1 supply of VC in UK, using a structured self-administered questionnaire. Patients were assessed for the suitability of VC and received appropriate advice from pharmacists. Descriptive statistics were used. Results: The final sample had 297 patients, who reported that pharmacists inquired about blood pressure and heart comorbidities (91.9%), relevant illnesses (87.9%), medications (86.5%), ED diagnosis (82.2%), and were advised to consult their doctor regarding ED (51.2%). Furthermore, 85.5% of patients were advised on how to take VC correctly, 82.2% on possible side effects for which they might have to discontinue taking VC and consult their doctor, 80.1% on being informed that ED could be caused by underlying conditions. About 65.0% reported that they had visited (19.2%) or planned to visit (45.8%) their doctor. A majority (68.7%) also indicated that they had received advice on lifestyle modifications to manage their ED-related health risks. Conclusion: This survey provided a reasonable confirmation of the effectiveness of the VC aRMMs program and assurance that ED patients, when requesting and purchasing VC in UK pharmacies, are assessed appropriately for suitability of VC and receive the appropriate advice from pharmacists.

A national additional risk minimization measures (aRMMs) program was implemented to train pharmacists for safe supply of non-prescription VC to erectile dysfunction (ED) patients in United Kingdom (UK). A cross-sectional, web-based survey enrolled ED patients who purchased at least 1 supply of VC in UK, using a structured self-administered questionnaire. Patients were assessed for the suitability of VC and received appropriate advice from pharmacists. The final sample had 297 patients, who reported that pharmacists inquired about blood pressure and heart comorbidities, relevant illnesses, medications, ED diagnosis, and were advised to consult their doctor regarding ED. Additionally, most of the patients had consulted or planned to consult their doctors, on how to take VC correctly, on possible side effects for which they might have to discontinue taking VC and consult their doctor, on being informed that ED could be caused by underlying conditions, and on lifestyle modifications. A majority also indicated that they had received advice on lifestyle modifications to manage their ED-related health risks. This survey provided a reasonable confirmation of the effectiveness of the VC aRMMs program and assurance that ED patients, when requesting and purchasing VC in UK pharmacies, are assessed appropriately for suitability of VC and receive the appropriate advice from pharmacists.

The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data.

Conducting clinical trials (CTs) has become increasingly costly and complex in terms of designing and operationalizing. These challenges exist in running CTs on novel therapies, particularly in oncology and rare diseases, where CTs increasingly target narrower patient groups. In this study, we describe external control arms (ECA) and other relevant tools, such as virtualization and decentralized clinical trials (DCTs), and the ability to follow the clinical trial subjects in the real world using tokenization. ECAs are typically constructed by identifying appropriate external sources of data, then by cleaning and standardizing it to create an analysis-ready data file, and finally, by matching subjects in the external data with the subjects in the CT of interest. In addition, ECA tools also include subject-level meta-analysis and simulated subjects' data for analyses. By implementing the recent advances in digital health technologies and devices, virtualization, and DCTs, realigning of CTs from site-centric designs to virtual, decentralized, and patient-centric designs can be done, which reduces the patient burden to participate in the CTs and encourages diversity. Tokenization technology allows linking the CT data with real-world data (RWD), creating more comprehensive and longitudinal outcome measures. These tools provide robust ways to enrich the CT data for informed decision-making, reduce the burden on subjects and costs of trial operations, and augment the insights gained for the CT data.

Blood pressure outcomes at 18 months in primary care patients prescribed remote physiological monitoring for hypertension: a prospective cohort study.

This pragmatic matched cohort study using EHR data extended the follow up to 18 months for BP outcomes comparing individuals prescribed remote patient monitoring (n = 288) and temporally-matched controls (n = 1152) from six primary care practices. After 18 months, the RPM-prescribed cohort had greater BP control < 140/90 mm Hg (RPM cohort: 71.5%, control cohort: 51.9%, p < 0.001) and lower systolic BP (131.6 versus 136.0 mm Hg, p = 0.004) using office and home measurements. BP control at 18 months assessed by office measurements only was also higher in the RPM group (62.2% versus 51.9%, p = 0.004).

Industry perspectives on the global use of validated blood pressure measuring devices.

A group of experts from reputable blood pressure measuring device (BPMD) manufacturers was invited to provide industry perspectives on the global use of validated BPMD. The authors support the recommendations of (1) using the consolidated universal ISO 81060-2:2018 in all future validation studies to ensure consistent and trustworthy quality standards; (2) validation studies to be led by investigators independent from the manufacturer; (3) validation study results to be published in peer-reviewed journals with an independent investigator as the corresponding author; and (4) validated BPMDs to be listed on validated device registries such as STRIDE BP, Validated Device Listing (VDL), and others that are backed by acknowledged scientific associations. The authors call for public awareness of the existence of legally marketed consumer BPMDs that lack sufficient evidence of clinical accuracy. Other important issues and future considerations were discussed, including the need: for awareness building and promoting the use of validated BPMDs among practitioners; to identify a non-mercury sphygmomanometer based reference device to validate BPMDs; to include all cuffs available for use with each BPMD in the validation study; for the promotion of validation studies for special patient populations; for validated wrist BPMDs as an alternative for some patients; for technical innovations to help reduce limitations related to the human aspect of validation studies; for validation of cuffless BPMDs; for validation through equivalency to validated base models; and to use validated BPMD in remote patient monitoring programs. A future collaborative to find solutions to support the use of validated BPMD is envisaged.

Remote physiologic monitoring for hypertension in primary care: a prospective pragmatic pilot study in electronic health records using propensity score matching.

Objectives: Since 2019, the Centers for Medicare and Medicaid Services covers remote physiologic monitoring (RPM) for blood pressure (BP) per hypertension diagnosis and treatment guidelines. Here, we integrated Omron VitalSight RPM into the health system's electronic health record to transmit BP and pulse without manual entry, assessed feasibility, and used pragmatic prospective matched cohort studies to assess initial effects in (1) uncontrolled (last two office BP ≥140/90 mmHg) and (2) general (diagnosed hypertension or last office BP ≥140/90 mmHg) hypertension patient populations. Materials and Methods: Seventeen clinicians at two internal medicine practices were oriented. Eligible patients were aged 65-85 years had Medicare insurance with ≥1 office visit in the previous year. We prospectively identified matched controls (age, sex, BP, and number of office visits in previous year) from other primary care practices within the health system and estimated the association between RPM availability (clinic-level) and patient BP outcomes after 6 months. ClinicalTrials.gov: NCT04604925. Results: Feasibility. Uptake was low at pilot clinics: 10 physicians prescribed RPM to 118 patients during the 6-month pilot. This included 7% (14/207) of the prespecified uncontrolled hypertension cohort and 3.3% (78/2356) of the general hypertension cohort. Surveyed clinicians (n = 4) reported changing their patients' medical treatment in response to RPM BPs, although they recommended having a dedicated RN or LPN to review BP readings. Effectiveness. At 6 months, BP control was greater at pilot practices than among matched controls (uncontrolled: 31.4% vs 22.8%; P = .007; general: 64.0% vs 59.7%; P < .001). Systolic BP at last office visit did not differ (mean [SD] 146.0 [15.7] vs 147.1 [15.6]; P = .48) in the uncontrolled population, and was lower in the general population (131.8 [15.7] vs 132.8 [15.9]; P = .04).The frequency of antihypertensive medication changes was similar in both groups (uncontrolled P = .986; general P = .218). Discussion and Conclusions: Uptake notwithstanding, RPM may have improved BP control. A potential mechanism is increased physician awareness of and attention to uncontrolled hypertension. Barriers to RPM use among physicians require further study.

Health-Care Resource Utilization and Treatment Patterns in Men with Erectile Dysfunction and Benign Prostatic Hyperplasia-Associated Lower Urinary Tract Symptoms in the United States: A Retrospective Database Study.

Objective: To compare health-care resource utilization (HCRU) outcomes in patients with erectile dysfunction (ED) and benign prostatic hyperplasia-associated lower urinary tract symptoms (BPH-LUTS) treated with tadalafil or non-phosphodiesterase-5 inhibitor (PDE5i), adherence to and persistence with tadalafil by dose in the United States (US). Methods: This was a noninterventional, real-world evidence study of men (aged ≥45 years) with ED and BPH-LUTS treated with tadalafil or non-PDE5i. The IQVIA US PharMetrics Plus claims database was used. Outcomes included all-cause and disease-specific HCRU over a 12-month follow-up. Persistence with and adherence to tadalafil were evaluated stratified by dose (10 or 20 mg as needed; 2.5 or 5 mg as once daily [OD]). Results: The final sample comprised 11,351 tadalafil and 48,722 non-PDE5i patients. For all-cause and disease-specific HCRU, including prescription fills, physician office visits, emergency room visits, laboratory tests, radiology examinations, outpatient surgical services, ancillary services, hospitalizations, mean number of utilizations, and proportions of patients with one or more utilizations, were lower for tadalafil compared with non-PDE5i patients. For all-cause HCRU, proportions of patients with one or more emergency room visits (18.6% vs 21.7%, p<0.0001) and outpatient surgical visits (63.0% vs 68.8%, p<0.0001) were significantly lower for tadalafil compared with non-PDE5i patients. For disease-specific HCRU, the proportion with one or more disease-specific physician office visits (55.1% vs 91.4%), laboratory tests (34.8% vs 58.2%), outpatient surgery (24.3% vs 38.9%), or outpatient ancillary services (18.0% vs 29.8%) were significantly lower for tadalafil compared with non-PDE5i patients (all comparisons, p<0.0001). Mean persistence days (179.8 vs 61.2), proportion persistence (35.8% vs 6.5%), and mean adherence (0.5 vs 0.2) were higher for tadalafil OD doses than as-needed tadalafil doses. Conclusion: Patients on tadalafil demonstrated less HCRU and higher persistence and adherence (OD versus as-needed tadalafil) than non-PDE5i patients, which demonstrates its benefit in the management of ED and BPH-LUTS in the US.

Digital hypertension management: clinical and cost outcomes of a pilot implementation of the OMRON hypertension management platform.

Importance: Home monitoring of blood pressure (BP) in hypertensive patients can improve outcomes, but challenges to both patient compliance and the effective transmission of home BP readings to physicians can limit the extent to which physicians can use this information to improve care. The OMRON Hypertension Management Platform (OMRON HMP) pairs a home BP cuff with a digital product that tracks data, provides reminders to improve patient compliance, and provides a streamlined source of information to physicians. Objective: The primary objective of the quality improvement (QI) project was to test the hypothesis that use of the OMRON HMP could reduce the number and cost of hypertension related claims, relative to a retrospectively matched cohort of insured members. A secondary objective was to demonstrate improvement in control of BP among patients. Design: Eligible members were recruited to the QI project between December 1, 2018 and December 30, 2020 and data collected for six months following recruitment. All members received the OMRON HMP intervention. Setting: Enrollment and data collection were coordinated on-site at selected PCP partner providers in Western Pennsylvania. Eligible members were identified from insurance claims data as those receiving care for primary hypertension from participating primary care physicians and/or cardiologists. Participants: Eligible members were between the ages of 35 and 85, with a diagnosis of primary hypertension. The retrospective cohort was selected from electronic medical records of Highmark-insured patients with hypertension who received care at Allegheny Health Network (AHN), a subsidiary of Highmark Health. Members were matched on baseline BP and lipid measures, age, smoking status, diabetes status, race and sex. Intervention: Daily home BP readings were recorded by the OMRON HMP app. Patient data was reviewed by clinical staff on a weekly basis and treatment plans could be adjusted in response to this data. Results: OMRON HMP users showed a significant increase in the number and cost of hypertension-related claims, contrary to the hypothesis, but did display improvements in control of BP. Conclusions and Relevance: The use of a digital platform to facilitate at-home BP monitoring appeared to improve BP control but led to increased hypertension-related costs in the short-term.

Blood pressure outcomes at 12 months in primary care patients prescribed remote physiological monitoring for hypertension: a prospective cohort study.

Remote patient monitoring (RPM) for hypertension enables automatic transmission of blood pressure (BP) and pulse into the electronic health record (EHR), but its effectiveness in primary care is unknown. This pragmatic matched cohort study using EHR data compared BP outcomes between individuals prescribed RPM and temporally-matched controls from six primary care practices. We retrospectively created a cohort of 288 Medicare-enrolled patients prescribed BP RPM (cases) and 1152 propensity score-matched controls (1:4). Matching was based on age, sex, systolic blood pressure (SBP), marital status, and other characteristics. Outcomes at 3, 6, 9 and 12 months were: controlling high BP (most recent BP < 140/90 mm Hg), antihypertensive medication intensification, and most recent SBP assessed using: all measurements, and office measurements only. At baseline, RPM-prescribed patients and controls had similar ages and systolic BP. BP control diverged at 3 months (RPM: 72.2%, control: 51%, p < 0.001). This difference persisted but decreased over follow-up. After 12 months, the RPM-prescribed cohort had greater BP control (RPM: 71.5%, control: 58.1%, p < 0.001) and lower SBP (132.3 versus 136.5 mm Hg, p = 0.003) using all measurements, but they did not differ using only office measurements (12 month BP control: 60.8% versus 58.1%, p = 0.44; SBP: 135.9 versus 136.5 mm Hg, p = 0.91). At 12 months, the most recent BP measurements were more current for RPM-prescribed patients (median [IQR] 8 [0-109] versus 134 [56-239] days). Net increases in antihypertensive medications by 12 months were similar. Implementation of RPM in primary care could inform hypertension management strategies and increase hypertension control. Registration: ClinicalTrials.gov identifier: NCT05562921.

Prospective Cohort Study of Remote Patient Monitoring with and without Care Coordination for Hypertension in Primary Care.

BACKGROUND: Out-of-office blood pressure (BP) measurements contribute valuable information for guiding clinical management of hypertension. Measurements from home devices can be directly transmitted to patients' electronic health record for use in remote monitoring programs. OBJECTIVE: This study aimed to compare in primary care practice care coordinator-assisted implementation of remote patient monitoring (RPM) for hypertension to RPM implementation alone and to usual care. METHODS: This was a pragmatic observational cohort study. Patients aged 65 to 85 years with Medicare insurance from two populations were included: those with uncontrolled hypertension and a general hypertension group seeing primary care physicians (PCPs) within one health system. Exposures were clinic-level availability of RPM plus care coordination, RPM alone, or usual care. At two clinics (13 PCPs), nurse care coordinators with PCP approval offered RPM to patients with uncontrolled office BP and assisted with initiation. At two clinics (39 PCPs), RPM was at PCPs' discretion. Twenty clinics continued usual care. Main measures were controlling high BP (<140/90 mm Hg), last office systolic blood pressure (SBP), and proportion with antihypertensive medication intensification. RESULTS: Among the Medicare cohorts with uncontrolled hypertension, 16.7% (39/234) of patients from the care coordination clinics were prescribed RPM versus <1% (4/600) at noncare coordination sites. RPM-enrolled care coordination group patients had higher baseline SBP than the noncare coordination group (148.8 vs. 140.0 mm Hg). After 6 months, in the uncontrolled hypertension cohorts the prevalences of controlling high BP were 32.5% (RPM with care coordination), 30.7 % (RPM alone), and 27.1% (usual care); multivariable adjusted odds ratios (95% confidence interval) were 1.63 (1.12-2.39; p = 0.011) and 1.29 (0.98-1.69; p = 0.068) compared with usual care, respectively. CONCLUSION: Care coordination facilitated RPM enrollment among poorly controlled hypertension patients and may improve hypertension control in primary care among Medicare patients.

Discovery of a Series of Potent, Selective, and Orally Bioavailable Nucleoside Inhibitors of CD73 That Demonstrates In Vivo Antitumor Activity.

CD73 (ecto-5'-nucleotidase) has emerged as an attractive target for cancer immunotherapy of many cancers. CD73 catalyzes the hydrolysis of adenosine monophosphate (AMP) into highly immunosuppressive adenosine that plays a critical role in tumor progression. Herein, we report our efforts in developing orally bioavailable and highly potent small-molecule CD73 inhibitors from the reported hit molecule 2 to lead molecule 20 and then finally to compound 49. Compound 49 was able to reverse AMP-mediated suppression of CD8+ T cells and completely inhibited CD73 activity in serum samples from various cancer patients. In preclinical in vivo studies, orally administered 49 showed a robust dose-dependent pharmacokinetic/pharmacodynamic (PK/PD) relationship that correlated with efficacy. Compound 49 also demonstrated the expected immune-mediated antitumor mechanism of action and was efficacious upon oral administration not only as a single agent but also in combination with either chemotherapeutics or checkpoint inhibitor in the mouse tumor model.