Background: Many factors contribute to developing and conducting a successful multi-data source, non-interventional, post-authorization safety study (NI-PASS) for submission to multiple health authorities. Such studies are often large undertakings; evaluating and sharing lessons learned can provide useful insights to others considering similar studies.
Objectives: We discuss challenges and key methodological and organizational factors that led to the delivery of a successful post-marketing requirement (PMR)/PASS program investigating the risk of cardiovascular and cancer events among users of mirabegron, an oral medication for the treatment of overactive bladder.
We aimed to improve the available information on morphology and stage for cutaneous melanoma in the population-based cancer registry of the Bucaramanga Metropolitan Area in Colombia. The incidence and survival rates and the distribution of melanoma patients by age, gender, anatomical subsite, and histological subtype were calculated. All 113 melanoma patients (median age 61) were followed up (median time 7.
View Article and Find Full Text PDFBMC Complement Med Ther
September 2023
Background: The use of complementary and alternative medicines (CAM) among cancer patients varies greatly. The available data suggest an increasing use of CAM over time and a higher prevalence in low- and middle-income countries. However, no reliable data are available from Latin America.
View Article and Find Full Text PDFBackground: Home health use is rising rapidly in the United States as the population ages, the prevalence of chronic disease increases, and older Americans express their desire to age at home. Enrollment in Medicare Advantage (MA) plans rather than Traditional Medicare (TM) has grown as well, from 13% of total Medicare enrollment in 2004 to 39% in 2020. Despite these shifts, little is known about outcomes and costs following home health in MA as compared with TM.
View Article and Find Full Text PDFThe increasing burden of cancer represents a substantial problem for Latin America and the Caribbean. Two Lancet Oncology Commissions in 2013 and 2015 highlighted potential interventions that could advance cancer care in the region by overcoming existing challenges. Areas requiring improvement included insufficient investment in cancer control, non-universal health coverage, fragmented health systems, inequitable concentration of cancer services, inadequate registries, delays in diagnosis or treatment initiation, and insufficient palliative services.
View Article and Find Full Text PDFBackground: Breast cancer (BC) has a high mortality rate in developing countries due to a scarcity of early detection. Risk communication is critical to support women who face the decision to undertake BC screening. Thus, they can balance their perceived and real risk, and make informed choices.
View Article and Find Full Text PDFObjectives: To compare outcomes and costs following skilled nursing facility (SNF) discharge for patients within a Medicare Advantage (MA) organization vs traditional Medicare (TM).
Study Design: Retrospective analysis of adults with a postacute SNF admission identified from MA claims (MA cohort: n = 56,228) and the Medicare 5% Limited Data Sets (TM cohort: n = 67,859).
Methods: Outcomes included hospitalization, proportion of days at home, and total medical costs during the 180 days post SNF discharge, and successful community discharge.
The COVID-19 pandemic poses a risk to mental health and may disproportionately affect people living with HIV (PLWH). This study examined the interaction of social support and resilient coping in predicting depressive symptoms among PLWH. PLWH residing in Buenos Aires, Argentina and in Miami, Florida (US) were asked to complete an anonymous survey on the impact of COVID-19.
View Article and Find Full Text PDFThe COVID-19 pandemic pose significant risk to mental health and may disproportionately affect people living with HIV (PLWH). This study examined the interaction of social support and resilient coping in predicting depressive symptoms among PLWH. : PLWH residing in Buenos Aires, Argentina and in Miami, Florida (US) were asked to complete an anonymous survey on the impact of COVID-19.
View Article and Find Full Text PDFGastric cancer (GC) is a public health issue with high incidence and mortality in Colombia due to tardy diagnosis and barriers to access to curative treatment; this leaves palliative care (PC) as the only option. Our aim is to describe the access barriers to PC perceived by adults with GC, caregivers and physician in Santander, Colombia. A qualitative study was carried out with the analysis of the grounded theory (Strauss and Corbin), through semi-structured interviews, after sampling for convenience we found that the access barriers were: administrative, economic, cultural, knowledge, communication, institutional and geographical; strategies to overcome barriers: screening programs, governmental surveillance, and investment in health.
View Article and Find Full Text PDFBackground: Glaucoma is a progressive, irreversible disease that can lead to vision loss and lower quality of life if treatment is not optimized. Effective glaucoma therapies are available to lower intraocular pressure (IOP) and minimize or delay disease progression. Nonetheless, adherence to treatment remains suboptimal for many patients.
View Article and Find Full Text PDFBackground: Demographic, clinical, and morphological characteristics of cutaneous melanoma are unknown for the Colombian population. We aim to provide these characteristics as well as population-based incidence and survival data.
Methods: All patients with an invasive cutaneous melanoma diagnosed in the period 2000-2009 registered in the population-based cancer registry of the metropolitan area of Bucaramanga were included for analysis (n = 169).
Objective: Readmission is costly among patients with type 2 diabetes (T2DM) in Medicare Advantage Prescription Drug Plans; identifying high-risk patients is necessary for targeting reduction programs. The objective of this study was to develop a claims-based algorithm to predict all-cause 30 day readmission among patients with T2DM.
Methods: This study used administrative data from 1 January 2012 through 31 January 2014.
Aims: To understand differences in patient reported outcomes (PRO) between patients initiating mirabegron or an antimuscarinic using a validated PRO instrument, OAB-Satisfaction (OAB-S).
Methods: This prospective observational study used real-time prescription claims from Humana to identify Medicare patients initiating mirabegron or an antimuscarinic to participate in a series of three phone surveys over ninety days.
Results: A total of 1897 mirabegron and 2444 randomly selected antimuscarinic initiators were identified; 174 mirabegron and 193 antimuscarinic initiators completed all three surveys.
Estimating the population attributable fraction (PAF) of melanomas due to sun exposure is challenging as there are no unexposed population nor reliable exposure data. In high incidence countries, a historic cohort of the South Thames cancer registry was used as a minimally exposed population using the formula PAF = (observed incidence-incidence in minimally exposure)/observed incidence. In this study, we apply this method, constructing a minimally exposed cohort for Colombia and also using the historical South Thames data, using melanoma incidence data from the population-based cancer registry of Cali, Colombia for the period 1967-2012.
View Article and Find Full Text PDFBackground: Lack of medication adherence is associated with significant morbidity and mortality, particularly among minorities. We aim to identify predictors of nonadherence to antiplatelet medications at the time of percutaneous coronary intervention (PCI) with stent among African American and Hispanic patients.
Methods: We used data collected for a randomized clinical trial that recruited 452 minority patients from a large US health insurance organization in 2010 post-PCI to compare telephone-based motivational interviewing by trained nurses with an educational video.
Background: Maintaining population-based registries requires adequate and sustained resources; however, to date there has been no systematic evaluation to identify the resource needs for cancer registration in most countries, including Colombia. A systematic assessment of the costs can quantify the funding required and identify processes to improve efficiency of cancer registries.
Methods: The Centers for Disease Control and Prevention's (CDC's) International Registry Costing Tool (IntRegCosting Tool) was tailored specifically for the Colombian registries and was used to collect resource use data from five regional population-based cancer registries: Barranquilla, Bucaramanga, Cali, Manizales, and Pasto.
Background: Clinical inertia, which has been defined as the recognition of a problem with a patient's management but failing to act, is a concern in type 2 diabetes (T2D) because it places the patient at risk of diabetes-related complications. Despite managed care organizations making significant investment in this area, little is known about the impact of educational programs aimed at aligning patients and their physicians with diabetes guidelines and thus overcoming clinical inertia.
Objective: To assess the impact of an educational intervention specifically designed to align patients and their physicians with 2012 American Diabetes Association (ADA) guidelines on glycated hemoglobin (A1c) testing frequency and insulin initiation.
Background: Reported adherence rates with ocular hypotensive medications typically range from 51% to 56% over the first year of therapy. As intraocular pressure (IOP) reduction slows the progression of vision loss from glaucoma, early identification of nonadherent members is crucial to effective disease management.
Objectives: To (a) identify member characteristics and other factors related to nonadherence with topical IOP-lowering medications available in administrative claims data and (b) create a predictive model incorporating these variables.
The conversion of natural habitats to farmland is a major driver of the global extinction crisis. Two strategies are promoted to mitigate the impacts of agricultural expansion on biodiversity: land sharing integrates wildlife-friendly habitats within farmland landscapes, and land sparing intensifies farming to allow the offset of natural reserves. A key question is which strategy would protect the most phylogenetic diversity--the total evolutionary history shared across all species within a community.
View Article and Find Full Text PDFBackground And Aims: Few studies evaluate the impact of anesthesia providers during procedures, such as colonoscopy, on low-risk patients. The objective of this study was to compare the effect of anesthesia providers on several outcome variables, including major morbidity, following screening colonoscopies.
Methods: A propensity-matched cohort study of 14,006 patients who enrolled with a national insurer offering health maintenance organization (HMO), preferred provider organization (PPO), and Medicare Advantage plans for a screening colonoscopy between July 1, 2005 and June 30, 2007 were studied.
Objective: To investigate whether health insurance affiliation and socioeconomic deprivation is associated with overall cause survival from gastric cancer in a middle-income country.
Methods: All patients resident in the Bucaramanga metropolitan area (Colombia) diagnosed with gastric cancer between 2003 and 2009 (n=1039), identified in the population-based cancer registry, were followed for vital status until 31/12/2013. Kaplan-Meier models provided crude survival estimates by health insurance regime (HIR) and social stratum (SS).
Background: Minorities have lower adherence to cardiovascular medications and have worst cardiovascular outcomes post coronary stent placement
Objective: The aim of this study is to compare the efficacy of phone-delivered Motivational Interviewing (MINT) to an educational video at improving adherence to antiplatelet medications among insured minorities.
Design: This was a randomized study.
Participants: We identified minorities with a recently placed coronary stent from an administrative data set by using a previously validated algorithm.
Background: In the global context, the establishment of population-based cancer registries, particularly in less developed regions, has become of strategic importance. The factors influencing the operation and sustainability of registries can be determinants for their success, despite the existence of uniform quality indicators in the cancer incidence information. Our objective was to determine the current state of the structure, organization and operation of populationbased cancer registries in Colombia, obtain information on their degree of development and identify specific problems that affect their operation and sustainability.
View Article and Find Full Text PDFIntroduction: Population-based cancer registries provide vital information for planning, prevention and cancer management. Information generated by the registries must be comprehensive, valid and comparable. Because of their importance, regular quality assessments are recommended.
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