Voluntary Data Submission Research Articles

Newly diagnosed cases of HIV in those aged 50 years and older and those less than 50: 2008-2017.

Canada's population is aging, with nearly forty percent of Canadians aged 50 years or more. As the population ages, unique challenges related to health are becoming evident, including increasing rates of sexually transmitted and bloodborne infections. Understanding the epidemiology of HIV in older adults is important to guide prevention and control programs. To assess trends in newly diagnosed cases of HIV in Canada among those aged 50 years and older (≥50 years) and those aged less than 50 (<50 years), and to compare their basic demographic characteristics and exposure categories for the period of 2008 to 2017. National surveillance of HIV is conducted by the Public Health Agency of Canada through voluntary submission of data by provincial/territorial public health authorities. Descriptive analyses were conducted on reported cases of HIV between January 1, 2008, to December 31, 2017 to compare the demographic profiles and exposure category for the two age groups. Between 2008 and 2017, the proportion of newly diagnosed HIV cases among those ≥50 years increased from 15.1% to 22.8%. The HIV diagnosis rates for both older males and older females increased over time, with a relatively higher increase for females. A higher proportion of newly diagnosed HIV cases were male in the older group (81.2%) compared to the younger group (74.6%). Among both older and younger males, the most common exposure category for HIV was being gay, bisexual and other men who have sex with men (gbMSM), followed by heterosexual contact and injection drug use; however, the relative proportions varied by age with the gbMSM category being higher in the <50 group. In Canada, over 20% of all newly diagnosed cases of HIV are now in people 50 years of age and older. HIV testing and prevention initiatives, historically aimed at younger populations, may not have the same impact for older populations. These data can be used to inform future public health actions designed to address HIV in older populations.

Evolving Global Regulatory Science Through the Voluntary Submission of Data: A 2013 Assessment.

Regulatory science, the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of regulated medical products, has advanced over time due to a number of factors. The FDA, the EMA, and the Pharmaceuticals and Medical Devices Agency (PMDA) have recently formalized voluntary data submission processes for the regulatory "qualification" of novel tools and methodologies for use in drug development. While recognizing that other mechanisms exist within the research community for driving scientific consensus on novel tools and methodologies, this article focuses on the formal regulatory process that addresses a tool's acceptability for incorporation by any sponsor into novel medical product development. Guidances, regulatory qualification opinions, and publications were reviewed to allow a systematic comparison of the process, content, and volume of submissions at the FDA, EMA, and PMDA. Qualification of new tools by regulatory agencies and subsequent adoption by drug developers are anticipated to speed therapeutic development for patients in need, build scientific consensus as to the usefulness and readiness of novel methodologies for understanding disease and therapeutic development, and decrease uncertainty between the regulators and sponsors regarding the appropriate application of new tools.

Results of Mechanical Ventricular Assistance for the Treatment of Post Cardiotomy Cardiogenic Shock

The voluntary submission of data on patients who receive mechanical circulatory assistance for post cardiotomy cardiogenic shock and acute myocardial infarction has resulted in an established data base for the ongoing evaluation of these devices. Since its inception in 1985, there have been 1,279 cases reported of implanted ventricular assist devices for post cardiotomy cardiogenic shock. The average duration of support for these devices is approximately 4 days. Those patients who underwent implantation of a centrifugal pump had significantly shorter periods of support when compared with the pneumatically supported group. Patients had similar periods of support when comparing clinical outcome. Approximately 70% of the reported cases underwent centrifugal assistance. The majority of reported cases were supported with isolated left ventricular assistance. There was no significant difference in overall outcome statistics when comparing type or mode of support. Approximately 45% of reported patients were weaned from circulatory assistance, and 25% of all patients survived to discharge. These numbers remain consistent with previously reported statistics. The results with acute myocardial infarction remain limited. Of the 96 reported patients, 26% were weaned from support and only 11.5% survived to discharge. This report continues to support the use and research for advancement of these devices toward the treatment of post cardiotomy cardiogenic shock.ASAIO Journal1996;42:211-218.

Results of Mechanical Ventricular Assistance for the Treatment of Post Cardiotomy Cardiogenic Shock

The voluntary submission of data on patients who receive mechanical circulatory assistance for post cardiotomy cardiogenic shock and acute myocardial infarction has resulted in an established data base for the ongoing evaluation of these devices. Since its inception in 1985, there have been 1,279 cases reported of implanted ventricular assist devices for post cardiotomy cardiogenic shock. The average duration of support for these devices is approximately 4 days. Those patients who underwent implantation of a centrifugal pump had significantly shorter periods of support when compared with the pneumatically supported group. Patients had similar periods of support when comparing clinical outcome. Approximately 70% of the reported cases underwent centrifugal assistance. The majority of reported cases were supported with isolated left ventricular assistance. There was no significant difference in overall outcome statistics when comparing type or mode of support. Approximately 45% of reported patients were weaned from circulatory assistance, and 25% of all patients survived to discharge. These numbers remain consistent with previously reported statistics. The results with acute myocardial infarction remain limited. Of the 96 reported patients, 26% were weaned from support and only 11.5% survived to discharge. This report continues to support the use and research for advancement of these devices toward the treatment of post cardiotomy cardiogenic shock.

Unwanted effects of drugs.

The committee on safety of drugs in Britain established a subcommittee on adverse reactions which relies on voluntary submission of data. In 4 instances the severity of the reaction was disproportionate to the benefit attributed to the drug and the drug was withdrawn. One drug was used in diaper rash one was a component of a long lasting influenza vaccine and 2 were used in the treatment of rheumatism. Analyses of the Physicians reports of the incidences of thromboembolism among users of oral contraceptives were performed and showed an increased risk of thromboembolism among pill users. Other epidemics discussed are phocomelia and thalidomide ileal obstruction and enteric coated potassium chloride primary pulmonary hypertension and aminorex death from asthma and pressurized aerosols paroxysmal headache and monoamine oxidase inhibitors.