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Noncommunicable diseases (NCDs) place a huge burden on healthcare systems and society as a whole. Relatively early in the coronavirus disease 2019 (COVID-19) pandemic, clinicians became aware that in individuals infected with COVID-19, those with preexisting NCDs such as diabetes mellitus and cardiovascular disease (CVD) were at a greater risk of poor outcomes and mortality than those without. The importance of adherence to medications and lifestyle changes to control and prevent NCDs has been a major focus for many years, but with limited success – the proportion of patients adherent and persistent to their medications remains very low. There are many facets to adherence and persistence. Recent evidence suggests that a patient-centric approach is important, and ensuring that a patient is both motivated and empowered is critical to improving adherence/persistence. The COVID-19 pandemic has brought many changes to the way in which patients with NCDs are managed, with telemedicine and ehealth becoming more common. Changes have also occurred in the way in which patients can gain access to medications during the pandemic. The potential for these changes forms the basis of improving the management of patients with NCDs both during and after the pandemic. Over the coming months, a huge amount of work will be put into initiatives to promote adherence to COVID-19 vaccination programs. Those at highest risk of severe COVID-19, such as people aged 80 years and older, are likely to receive the vaccine first in some parts of world. Finally, social determinants of health are critical elements that can impact not just the likelihood of having an NCD or becoming infected with COVID-19, but also access to healthcare, and a patient’s adherence and persistence with their treatments.

Joseph S Imperato,1 Kelly H Zou,1 Jim Z Li,1 Tarek A Hassan2 1Global Medical Analytics and Real-World Evidence, Viatris Inc., Canonsburg, PA, USA; 2Global Medical Affairs, Ophthalmology, Viatris Inc, Canonsburg, PA, USACorrespondence: Tarek A Hassan, Global Medical Affairs, Ophthalmology, Viatris Inc, 1000 Mylan Boulevard, Canonsburg, PA, 15317, USA, Tel +1 347 443 2850, Email tarek.hassan@viatris.comPurpose: To investigate clinical management of primary open-angle glaucoma (POAG) in the United States using real-world evidence and to examine healthcare resource utilization (HCRU), medication adherence/persistence, and procedure use.Design: A cross-sectional, retrospective analysis of Optum’s de-identified Market Clarity Dataset (July 1, 2013–December 31, 2019).Patients and Methods: Patients ≥ 18 years with POAG diagnosis and continuous enrollment for 1-year pre- and post-index were eligible and categorized into four mutually exclusive cohorts: CH1, treated with antiglaucoma medication(s) only; CH2, underwent glaucoma procedure(s) only; CH3, treated with antiglaucoma medication(s) and underwent procedure(s); and CH4, received no treatment for POAG. Adherence and persistence with antiglaucoma medications, and disease-specific HCRU were analyzed. Pairwise two-sample comparisons and multivariate regressions were conducted.Results: Examined 232,572 eligible patients (CH1=60,895; CH2=4330; CH3=6027; CH4=161,320). Prostaglandin analogs were most prescribed antiglaucoma medications (CH1: 69.7%; CH3: 62.7%), of which latanoprost was most common (CH1: 51.3%; CH3: 46.1%). Disease-specific office visits occurred in 26.3%, 78.2%, 75.0%, 23.8%, and surgical services visits occurred in 3.8%, 36.3%, 42.5%, 3.3%, in CH1-CH4, respectively. Adherence was higher (medication possession ratio: 47.1% vs 39.4%; P< 0.0001), and more patients remained persistent across 1-year post-index period in CH1 vs CH3 (25.4% vs 16.1%; P< 0.0001). Positive predictors of medication persistence included being female, ≥ 55 years, and history of dyslipidemia or thyroid disease (all P≤ 0.0003).Conclusion: Overall, 70% POAG patients might not have received antiglaucoma treatment. Since POAG is a slowly progressive blinding disease, the lack of antiglaucoma treatment and suboptimal adherence/persistence with medications are of major concerns. Targeted screening and educational approaches are needed to improve POAG management.Keywords: adherence, antiglaucoma, health care resource utilization, persistence, real-world evidence

Noncommunicable diseases (NCDs) are the leading causes of mortality and morbidity across the world and factors influencing global poverty and slowing economic development. We summarize how the potential power of real-world data (RWD) and real-world evidence (RWE) can be harnessed to help address the disease burden of NCDs at global, national, regional and local levels. RWE is essential to understand the epidemiology of NCDs, quantify NCD burdens, assist with the early detection of vulnerable populations at high risk of NCDs by identifying the most influential risk factors, and evaluate the effectiveness and cost-benefits of treatments, programs, and public policies for NCDs. To realize the potential power of RWD and RWE, challenges related to data integration, access, interoperability, standardization of analytical methods, quality control, security, privacy protection, and ethical standards for data use must be addressed. Finally, partnerships between academic centers, governments, pharmaceutical companies, and other stakeholders aimed at improving the utilization of RWE can have a substantial beneficial impact in preventing and managing NCDs.

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 p

A vast quantity of real-world data (RWD) are available to healthcare researchers. Such data come from diverse sources such as electronic health records, insurance claims and billing activity, product and disease registries, medical devices used in the home, and applications on mobile devices. The analysis of RWD produces real-world evidence (RWE), which is clinical evidence that provides information about usage and potential benefits or risks of a drug. This review defines and explains RWD, and it also details how regulatory authorities are using RWD and RWE. The main challenges in harnessing RWD include collating and analyzing numerous disparate types or categories of available information including both structured (eg, field entries) and unstructured (eg, doctor notes, discharge summaries, social media posts) data. Although the use of artificial intelligence to capture, amalgamate, standardize, and analyze RWD is still evolving, it has the potential to support the increased use of RWE to improve global health and healthcare.

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

Since the approval and availability of the first biosimilar in 2015 in the United States (US), evidence regarding the post-marketing safety of cancer supportive care biosimilars remains limited.The aim was to explore the adverse event (AE) reporting patterns and detect disproportionate reporting signals for cancer supportive care biosimilars in the US compared to their originator biologics.The US Food and Drug Administration Adverse Event Reporting System database (January 1, 2004-March 31, 2020) was used to identify AE reports for filgrastim, pegfilgrastim, and epoetin alpha by type of product (originator biologics vs. biosimilars) and report characteristics. Plots of AE reports against years were used to reveal the reporting patterns. Disproportionality analyses using reporting odds ratios (RORs) were conducted to detect differences in serious and specific AEs between studied drugs and all other drugs. Breslow-Day tests were used to determine homogeneity between the originator biologic-biosimilar pair RORs for the same AE.Total numbers of AEs for all studied biosimilars increased after marketing. More AE reports were from female patients for all of the studied drugs. More AEs for originator biologics and filgrastim biosimilar were reported by health professionals, while the highest proportion of reports came from consumers for pegfilgrastim and epoetin alpha biosimilars (29% and 44.1%, respectively). Signals of disproportionate reporting in serious AEs were detected for a pegfilgrastim biosimilar (FulphilaOur findings support the similarity in the signals of disproportionate reporting between cancer supportive care originator biologics and biosimilars, except for Fulphila

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

Vaibhav B Katkade, Kafi N Sanders, Kelly H Zou Pfizer Inc, New York, NY, USA Abstract: Evidence from medication use in the real world setting can help to extrapolate and/or augment data obtained in randomized controlled trials and establishes a broad picture of a medication’s place in everyday clinical practice. By supplementing and complementing safety and efficacy data obtained in a narrowly defined (and often optimized) patient population in the clinical trial setting, real world evidence (RWE) may provide stakeholders with valuable information about the safety and effectiveness of a medication in large, heterogeneous populations. RWE is emerging as a credible information source; however, there is scope for enhancements to real world data (RWD) sources by understanding their complexities and applying the most appropriate analytical tools in order to extract relevant information. In addition to providing information for clinicians, RWE has the potential to meet the burden of evidence for regulatory considerations and may be used in approval of new indications for medications. Further understanding of RWD collection and analysis is needed if RWE is to achieve its full potential. Keywords: electronic health records, evidence-based medicine, real world data, real world evidence, randomized controlled trial

Aims Overactive bladder (OAB) disproportionately affects older-aged adults, yet most randomized controlled trials (RCTs) underrepresent patients ≥65. This systematic literature review (SLR) identified RCTs evaluating β-3 adrenergic agonists or muscarinic antagonists in elderly patients with OAB, and compared study quality across trials. Methods MEDLINE®, Embase®, and Cochrane Collaboration Central Register of Clinical Trials databases were searched from inception through April 28, 2015 to identify published, peer-reviewed RCT reports evaluating β-3 adrenergic agonists or muscarinic antagonists in elderly OAB patients (either ≥65 years or study-described as “elderly”). To assess study quality of RCT reports, we focused on internal/external validity, assessed via two scales: the validated Effective Public Health Practice Project [EPHPP]): Quality Assessment Tool for Quantitative Studies, and a tool commissioned by the Agency for Healthcare Research and Quality (AHRQ). Results Database searches yielded 1380 records that were then screened according to predefined inclusion/exclusion criteria. We included eight papers meeting study criteria. Despite scientific community efforts to improve RCT reporting standards, published reports still include incomplete and inconsistent reporting—of subject attrition, baseline patient characteristics, inclusion/exclusion criteria, and other important details. Only three of the eight OAB RCTs in this review received quality ratings of Strong (EPHPP) or Fair (AHRQ) and were multicenter with large samples. Conclusions Despite the prevalence of OAB among older age individuals, relatively few RCTs evaluate OAB treatments explicitly among elderly subjects. The findings from this quality assessment suggest some areas for improvement in both conduct and reporting of future RCTs assessing OAB treatment in elderly.

Months of conference planning can take mere minutes with a dash of optimisation. By Jason Pan, Kelly H. Zou, Ching-Ray Yu, Franklin W. Sun, and Martin O. Carlsson

Aims Overactive bladder (OAB) and benign prostatic hyperplasia (BPH) are highly prevalent conditions that place a large burden on the United States (US) health care system. We sought to analyze patterns of prescription medication usage for incident OAB in men and women, and for incident BPH in men using US health insurance claims data. Materials and Methods This study used Truven Health MarketScan® Commercial and Medicare Supplemental Research databases. The data were pooled from diverse points of care. BPH subjects included men age 18+ with the first and last two diagnoses of BPH ≥30 days apart and no BPH diagnosis for 1 year prior. OAB subjects included men and women age 18+, who were diagnosed similarly with incident OAB. The type of medication, medication continuation (persistence), and switching to a different medication were analyzed through September 30, 2013. Results Medication persistence was much higher overall for BPH than OAB (56% vs 34%, respectively, P

Smoking is the leading preventable cause of death, and tobacco control professionals continue to make progress in cessation efforts. Pharmacists can assist smokers seeking to quit by offering counseling on smoking cessation pharmacotherapies. Pragmatic randomized trials are useful for investigating practical questions about an intervention's risks, benefits, and costs in routine clinical practice.To evaluate an enhanced pharmacy care (EPC) program involving personalized pharmacist-provided telephone counseling for supporting prescription smoking cessation medications compared with usual care (UC).Cigarette smokers filling a newly prescribed smoking cessation pharmacotherapy and with pharmacy benefits managed by Express Scripts were recruited. Qualified subjects were randomized 1:1 to EPC and UC. Subjects in EPC received 3 telephone-counseling sessions from specialist pharmacists during the early course of the study, while subjects in UC did not receive any counseling sessions. Study outcomes were collected through telephone contact and using the Express Scripts prescription database. The primary outcome assessed the 1-week point prevalence (PP) of smoking abstinence at the end of the trial (week 12). Secondary outcomes included 4-week PP at week 12 and adherence, evaluated by proportion of days covered (PDC), to prescribed smoking cessation pharmacotherapies.There were 1,017 randomized subjects. Among them, 1,002 subjects were included in the analysis, and 513 were randomized into EPC and 489 into UC. Baseline demographics, smoking history, and prescribed smoking cessation pharmacotherapies were comparable. Varenicline and nicotine replacement therapy (NRT) were most frequently prescribed for smoking cessation. In EPC, 46.0% received all 3 counseling sessions; 29.4% received 2 sessions; and 14.6% received 1 session. Overall, 353 subjects in EPC and 383 subjects in UC completed the week 12 assessment. In the analysis for 1-week PP of smoking abstinence at week 12, the percentage of abstainers in EPC was numerically higher than in UC (42.3% vs. 38.2%) with OR = 1.24, 95% CI = 0.96-1.61. It was not statistically significant. Adherence to prescription smoking cessation medication was significantly higher in EPC versus UC (49.7% vs. 45.6%; P = 0.033).This study evaluated whether a telephone-based pharmacy care program, provided by pharmacists and designed to support attempted quitters, improved quitting and increased adherence over usual care. The findings suggest that an enhanced program may benefit smokers by increasing prescription smoking cessation medication adherence. Future research should explore this program's effect on smokers who are compliant, based on insights on quitting provided by the post hoc analyses and limitations of the current study design.This study was sponsored by Pfizer. Gong, Baker, Zou, Bruno, Jumadilova, and Lawrence are employees and stockholders of Pfizer. Wilson and Ewel are employees of United BioSource Corporation, which received funding from Pfizer for conducting this study and for the development of this manuscript. Study concept and design were contributed by Gong, Bruno, and Ewel, with assistance from Jumadilova, Lawrence, and Zou. Gong, Jumadilova, Lawrence, and Ewel collected the data. Data interpretation was performed by Baker, Zou, and Wilson, assisted by Gong, Lawrence, and Ewel. The manuscript was written by Baker, Ewel, and Gong, with assistance from the other authors, and revised by Baker, Wilson, Zou, and Gong, with assistance from Bruno and Jumadilova.

SummaryAims With self-reporting of erectile dysfunction (ED) in population-based surveys, men with ED may not represent men who are bothered sufficiently to seek an ED diagnosis and treatment. We used real-world observational data to assess: 1) the prevalence of ED diagnosis or treatment by age subgroups; and 2) the relationship of age with ED diagnosis or treatment after controlling for ED-related comorbidities in the USA. Methods This cross-sectional study used de-identified claims data (MarketScan® databases; primary analysis). Sensitivity analysis was conducted using electronic health records (Humedica® database). Inclusion criteria were men aged ≥18 years with a 360-day continuous enrollment before the index date. We assessed the prevalence of ED diagnosis or phosphodiesterase type 5 inhibitor (PDE5I) prescription by age and the risk for ED diagnosis or treatment by age after controlling for comorbidities (hypertension, other cardiovascular disease, diabetes mellitus, depression and benign prostatic hyperplasia). Results Of 19,833,939 men meeting inclusion criteria in the primary analysis, only 1 108 842 (5.6%) had an ED diagnosis or PDE5I prescription (mean [SD] age: 55.2 [11.2] years). Prevalence of ED diagnosis or treatment increased from age 18–29 years (0.4%) to 60–69 years (11.5%), then decreased in the seventh (11.0%), eighth (4.6%), and ninth (0.9%) decades. Men with ED diagnosis or treatment had a higher prevalence of any comorbidity (63.1% vs 29.3% for men without ED) and of each comorbid condition. In multivariate analyses, age was an independent risk factor for ED diagnosis or treatment. Sensitivity analysis provided consistent results. Conclusions In a real-world setting in the USA, the prevalence of ED diagnosis or PDE5I treatment is generally low, increases with age, decreases in very old men, and is associated with increased prevalence of comorbidities. Age is an independent risk factor for ED diagnosis or treatment after controlling for comorbidities.

The 11th International Conference on Health Policy Statistics (ICHPS) conference was successfully held from October 7 to 9, 2015, in Providence, Rhode Island, espousing the theme “Statistical Science at the Forefront of Health Policy Research”. Authors of research presented at ICHPS 2015, in both posters and talks, were invited to submit their completed papers in two special issues of Health Services and Outcomes Research Methodology. In addition, the issues feature interviews with the winners of the American Statistical Association’s Health Policy Statistics Section of the Long-Term Excellence and Mid-career Awards.

Objective To examine the “real-world” overactive bladder (OAB) practice patterns using national data in the United States. Materials and Methods The Humedica EHR database was queried. This database consists of de-identified patient records from a network of organizations treating approximately over 30 million patients across states in the United States. The entire study period was from July 1, 2008, to September 30, 2013. Patients with a diagnosis of OAB between July 1, 2009, and June 30, 2012 were included and followed. Patient comorbidities, demographics, diagnostic testing, and medication usage were analyzed. Results Of 19,309,600 subjects enrolled during the study period, 46,648 adults had a diagnosis of OAB, with follow-up of at least 6 months, and met the inclusion criteria. There were 35,315 women and 11,333 men. Compared with women, men with OAB were more likely to undergo post-void residual measurement (32% vs 22%) and diagnostic cystoscopy (10% vs 7%). Women were more likely than men to undergo urodynamics (7% vs 3%). Overall, 34% of women and 19% of men diagnosed with OAB were prescribed medication. Conclusion Few patients with OAB underwent invasive diagnostic testing. Anticholinergic medication was prescribed to a minority of patients diagnosed with OAB, indicating possible underuse of a potentially effective therapy. Men were less likely than women to receive medical therapy, despite the fact that OAB is common in both sexes.

Summary Objectives This study examined potential benefits of diagnosing and treating elderly adults with overactive bladder (OAB) symptoms. Methods Data were analysed from the OAB Re-Contact Study (N = 2750), a cross-sectional, self-reported Internet survey. Elderly respondents (65+ years old) with OAB were identified according to current medication use to control OAB symptoms or by scores > 14 (men) or > 16 (women) on the OAB Awareness Tool. Treated were those currently using prescription medication and never treated were those who never used prescription medication for OAB. Outcome measures included health-related quality of life, activity impairment, OAB-related severity and symptoms, and healthcare resource use (e.g. hospitalisations). Generalised linear models predicted health outcomes as a function of diagnosis or treatment, adjusting for covariates. Results Diagnosed vs. not diagnosed elderly respondents had higher mental component summary (MCS) scores and SF-6D health utilities, and less activity impairment. Treated vs. never treated elderly respondents had higher MCS and SF-6D health utilities, less activity impairment, fewer OAB symptoms, lower OAB Awareness Tool scores, and lower odds of having bladder problems or incontinence. There were no significant differences in healthcare resource use. Further analysis by age group (middle-aged vs. elderly respondents) revealed significantly greater diagnosis- and treatment-related benefits on MCS (2.93 and 4.49 points more, respectively) and activity impairment (1.24 and 1.37 times as much, respectively) among elderly respondents. Conclusions Diagnosis and treatment were each associated with a lower health burden for elderly adults with OAB symptoms. These findings highlighted the importance of diagnosis and treatment in alleviating OAB symptoms and their impact on health outcomes.

The purpose of this study was to assess the effectiveness and safety of air versus liquid enema reduction in the treatment of intussusception in children.Literature searches of the PubMed, Embase, and Cochrane Library databases were conducted from January 1, 1966, through May 31, 2013. Articles on the use of air or liquid enema in children with a confirmed diagnosis of intussusception and reporting either a success rate for enema reduction of intussusception or a perforation rate were selected. Enema reduction success rate, perforation rate, and recurrence rate were the main outcomes and were calculated by random effects modeling.One hundred two articles (101 reporting success rate, 71 reporting perforation rate) were included that presented results for 32,451 children (age range, 1 day-22 years; boys, 66%; girls, 34%). In 44 studies (16,187 children), the combined estimate for success rate of air enema was 82.7% (95% CI, 79.9-85.6%; inconsistency index [I(2)] = 97%), and in 52 studies (13,081 children) of liquid enema, it was 69.6% (95% CI, 65.0-74.1%; I(2) = 98%). In 38 studies (15,752 children), the combined estimate of perforation rate for air enema was 0.39% (95% CI, 0.23- 0.55%; I(2) = 40%), and in 30 studies (9429 children) of liquid enema, it was 0.43% (95% CI, 0.24- 0.62%; I(2) = 9%). Among 10,494 children (26 studies) undergoing air enema reduction, the rate of first intussusception recurrence was 6% (95% CI, 4.5-7.5%; I(2) = 89%), similar to the 7.3% (95% CI, 5.8-8.8%; I(2) = 71%) found for 4004 children (24 studies) undergoing liquid enema reduction.Air enema was superior to liquid enema for intussusception reduction. The success rate was higher without a difference in perforation rate. Limitations included heterogeneity and publication bias.