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Suicidal behavior and substance use disorders (SUDs) are important public health concerns. Prior suicide attempts and SUDs are two of the most consistent predictors of suicide death, and clarifying the role of SUDs in the transition from suicide attempt to suicide death could inform prevention efforts.
We used national Swedish registry data to identify individuals born 1960–1985, with an index suicide attempt in 1997–2017 (N = 74 873; 46.7% female). We assessed risk of suicide death as a function of registration for a range of individual SUDs. We further examined whether the impact of SUDs varied as a function of (i) aggregate genetic liability to suicidal behavior, or (ii) age at index suicide attempt.
In univariate models, risk of suicide death was higher among individuals with any SUD registration [hazard ratios (HRs) = 2.68–3.86]. In multivariate models, effects of specific SUDs were attenuated, but remained elevated for AUD (HR = 1.86 95% confidence intervals 1.68–2.05), opiates [HR = 1.58 (1.37–1.82)], sedatives [HR = 1.93 (1.70–2.18)], and multiple substances [HR = 2.09 (1.86–2.35)]. In secondary analyses, the effects of most, but not all, SUD were exacerbated by higher levels of genetic liability to suicide death, and among individuals who were younger at their index suicide attempt.
In the presence of a strong predictor of suicide death – a prior attempt – substantial predictive power is still attributable to SUDs. Individuals with SUDs may warrant additional suicide screening and prevention efforts, particularly in the context of a family history of suicidal behavior or early onset of suicide attempt.
Registries play an important role of identifying large groups of individuals who may be eligible for clinical trials. Major advantages include scalability, ability to reach many individuals with few resources, and to connect with individuals who may not otherwise engage in research. Major challenges include generalizability, data integrity, data validity, and study drop-out. This chapter reviews the four largest online registries in the USA: the Brain Health Registry, the Alzheimer’s Prevention Registry and GeneMatch, Cleveland Clinic’s HealthyBrains, and Alzheimer’s Association TrialMatch. Participant engagement strategies and current demographics are summarized. We also discuss a newly established program to create Trial-ready Cohort for Preclinical and Prodromal AD (TRC-PAD) with the aim to accelerate clinical trial enrollment. It is important to build a large cohort, to identify enough participants eligible and interested in clinical trials. Compatibility with smartphones, and further study of engagement and retention strategies with a focus on under-represented groups are critical to achieve our ultimate goal of trial participants representing the full US population.
The ongoing European Prevention of Alzheimer’s Dementia Programme (EPAD) was established in 2015 to create a platform for Phase 2 testing of interventions for the secondary prevention of Alzheimer’s disease (AD) dementia. This initiative was the largest of its kind globally. The original funding from the Innovative Medicines Initiative ensured that through their public-private partnership model, the programme benefited from expertise, know-how, and resources from academia, the pharmaceutical arena and third sector. Setting the vision, managing the innovative programme and operationalising scores of crucial and interdependent elements was a substantial governance and project management undertaking. The programme is ongoing with data and samples accessible through state-of-the-art systems in partnership with the Alzheimer’s Disease Data Interoperability programme. Follow-up of research participants is being organised and their involvement in a range of clinical trials is being facilitated via collaboration with the Global Alzheimer’s Platform. The challenges and lessons learned from EPAD are important as the field continued to advance and new therapies are developed.
The Pediatric Acute Care Cardiology Collaborative (PAC3) was established to improve acute care cardiology outcomes through the development of an accurate and well-validated clinical registry. We report the validation results of the initial PAC3 registry audits and describe a novel regional audit format developed to accommodate a rapidly expanding membership facilitate collaborative learning and allow for necessary modification due to the COVID-19 pandemic.
Materials and methods:
Six hospitals were audited using a regional audit format and three hospitals were subsequently audited virtually. Critical and challenging-to-collect data elements were audited among at least 40 randomly selected cases. Discrepancies were categorised as either major or minor depending on their relative importance to patient outcomes and clinical care. Results were tabulated and reported.
We audited 386 encounters and 27,086 individual data fields across 9 hospitals. The aggregate overall accuracy rate was 99.27% and the aggregate major discrepancy rate was 0.51%. The overall accuracy rate ranged from 98.77% to 99.59%, and the major discrepancy rate ranged from 0.26% to 0.88% across the cohort. No appreciable difference was seen between audit formats. Both the regional and virtual audit methods were viewed favourably by participants.
A low data discrepancy rate was found demonstrating that the PAC3 registry is a highly accurate data source for use in quality improvement, benchmarking, and research. Regional audits and virtual audits were both successfully implemented.
The North American AED Pregnancy Registry (NAAPR) provides crucial data for understanding the risks of antiepileptic drug (AED) exposure in pregnancy. This study aims to quantify the Canadian contribution to NAAPR and compare AED usage in pregnancy in Canada and the USA.
Enrollment rate ratios (ERR) to NAAPR, adjusted for the populations of women of childbearing age, were calculated for the USA, Canada, and for the different Canadian provinces. Methods of enrollment to NAAPR and AED usage were compared between the two countries using chi-squared tests.
Between 1997 and 2019, 10,215 pregnant women enrolled into NAAPR: 4.1% were Canadian (n = 432, ERR = 0.39, CI95% = 0.35–0.43). Within Canada, no patients were enrolled from the three northern territories or from Prince Edward Island. While fewer patients than expected enrolled from Quebec (ERR = 0.35, CI95% = 0.19–0.58), Nova Scotia had the highest enrollment rate (ERR = 1.55; CI95% = 0.66–3.11). Compared with their American peers, Canadians were less likely to have been enrolled by their healthcare provider and more likely to have been enrolled via social media (p < 0.01). Canadian women were more likely to be taking carbamazepine (24% vs. 15%; p < 0.01) or valproic acid (8% vs. 4%; p < 0.01).
The proportion of Canadian enrollees into NAAPR was less than expected based on the relative population size of Canadian women of reproductive age. Greater Canadian enrollment to NAAPR would contribute to ongoing worldwide efforts in assessing the risks of AEDs use in pregnant women and help quantify rates of AED usage, major congenital malformations, and access to subspecialized epilepsy care within Canada.
A year after the emergence of a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), as a new crisis in respiratory infections, there remain many uncertainties and unknowns about SARS-CoV-2 and the disease it causes, called coronavirus disease (COVID-19). Although COVID-19 is known as a respiratory disease, some atypical manifestations have been seen, different from those seen in other types of viral respiratory infections. This paper aims to describe designing, launching, and implementing a data collection system for all respiratory diseases, with a focus on SARS-CoV-2 from the onset of this pandemic.
The current registry is designed in compliance with the standard Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines, along with the declaration of Helsinki principles.
A respiratory disease registry, with an emphasis on COVID-19 and other co-infections, was developed. Data consisted of demographic, clinical, and supporting information about SARS-CoV-2 and other respiratory viral diseases.
It is hoped that the current data registry will facilitate patient evaluation and improve the outcomes of cases of respiratory infection defined by a particular condition, disease, or exposure. Moreover, the registry can harmonize data about the treatment, outcomes, and well-being of patients who receive care over time, and identify best practices.
The Coronavirus Disease 2019 (COVID-19) pandemic has had substantial global morbidity and mortality. Clinical research related to prevention, diagnosis, and treatment of COVID-19 is a top priority. Effective and efficient recruitment is challenging even without added constraints of a global pandemic. Recruitment registries offer a potential solution to slow or difficult recruitment.
The purpose of this paper is to describe the design and implementation of a digital research recruitment registry to optimize awareness and participant enrollment for COVID-19-related research in Baltimore and to report preliminary results.
Planning began in March 2020, and the registry launched in July 2020. The primary recruitment mechanisms include electronic medical record data, postcards distributed at testing sites, and digital advertising campaigns. Following consent in a Research Electronic Data Capture survey, participants answer questions related to COVID-19 exposure, testing, and willingness to participate in research. Branching logic presents participants with studies they might be eligible for.
As of March 24, 2021, 9010 participants have enrolled, and 64.2% are female, 80.6% are White, 9.4% are Black or African American, and 6% are Hispanic or Latino. Phone outreach has had the highest response rate (13.1%), followed by email (11.9%), text (11.4%), and patient portal message (9.4%). Eleven study teams have utilized the registry, and 4596 matches have been made between study teams and interested volunteers.
Effective and efficient recruitment strategies are more important now than ever due to the time-limited nature of COVID-19 research. Pilot efforts have been successful in connecting interested participants with recruiting study teams.
Despite the training and skills of airway managers, airway management complications still occur and may cause patient harm or death. The causes are multifactorial and may include patient, environment and clinician factors. Airway complications likely contribute to a significant proportion of deaths due to anaesthesia and are certainly more common outside the operating theatre and especially in the critical care unit. Reported incidences of failure and harm during airway management vary depending on the population studied and definitions used. Numbers may be of less value than understanding themes that help us improve care and reduce harm. The chapter emphasises that conventional research (e.g. device evaluation studies and randomised controlled trials) may be of little use in identifying low frequency events and complications because of their restricted inclusion and exclusion criteria, the use of devices only by experts and in conventional settings and because of their focus on efficacy rather than safety. The chapter highlights the important and growing role of registries and databases. Several are described in detail including the 4th National Audit Project and the Dutch ‘mini-NAP’. The value and limitations of litigation databases are explored. Specific complications of note are described at the end of the chapter.
Successful social media recruitment requires specific expertise and constant upkeep, placing an inordinate burden on study teams. Over half of the study teams at the University of Michigan (U-M) surveyed about recruitment assistance needs indicated that they wanted to use social media as a recruitment strategy, but lacked the expertise to do so. We thus built a service to centralize social media recruitment across the university. This involved assembling the right expertise, creating a centralized social media profile, creating linkages to other digital recruitment platforms, building the financial structure, and operationalizing the service. So far, we have helped 94 study teams launch social media campaigns on Facebook and Instagram. These campaigns resulted in 1,653,675 users being reached, of which 20,546 users actively showed interest in participating in the corresponding studies. We followed 18 studies further, who reported a total of 345 social media participants as being enrolled, resulting in an average cost-per-contact (CPC) of $8.72 and an average cost-per-enrollee (CPE) of $55.21. The combination of communication expertise, streamlined administrative processes, and linkages to a centralized research participation registry has allowed us to help a large number of study teams seamlessly engage broad and diverse populations.
The Fontan Outcomes Network was created to improve outcomes for children and adults with single ventricle CHD living with Fontan circulation. The network mission is to optimise longevity and quality of life by improving physical health, neurodevelopmental outcomes, resilience, and emotional health for these individuals and their families. This manuscript describes the systematic design of this new learning health network, including the initial steps in development of a national, lifespan registry, and pilot testing of data collection forms at 10 congenital heart centres.
The International Criminal Court is a distinct international organization headquartered in The Hague. It works in close cooperation with the United Nations but is independent of it. The Court is composed of four ‘organs’: the Presidency, the Chambers, the Office of the Prosecutor and the Registry. The Presidency consists of the President and the two Vice-Presidents, who are elected by the Plenary of judges. Judges are elected by the Assembly of States Parties to terms of nine years; they must be nationals of a State Party. The judges are constituted into Divisions, for Appeals, Trials and Pre-Trial proceedings. Within each division may be one or more Chambers. The Appeals Chamber is generally composed of five judges while the other Chambers are generally made up of three judges, although a Single Judge may issue rulings in some cases. The head of the Office of the Prosecutor is the Prosecutor, who is elected to a nine-year term by the Assembly of States Parties. The Registrar is nominated by the judges but elected by the Assembly of States Parties and serves a term of five years. The Registrar is the principal administrative officer. The Court’s annual budget is proposed by its organs but must be confirmed by the Assembly of States Parties.
Spinal muscular atrophy (SMA) is a devastating rare disease that affects individuals regardless of ethnicity, gender, and age. The first-approved disease-modifying therapy for SMA, nusinursen, was approved by Health Canada, as well as by American and European regulatory agencies following positive clinical trial outcomes. The trials were conducted in a narrow pediatric population defined by age, severity, and genotype. Broad approval of therapy necessitates close follow-up of potential rare adverse events and effectiveness in the larger real-world population.
The Canadian Neuromuscular Disease Registry (CNDR) undertook an iterative multi-stakeholder process to expand the existing SMA dataset to capture items relevant to patient outcomes in a post-marketing environment. The CNDR SMA expanded registry is a longitudinal, prospective, observational study of patients with SMA in Canada designed to evaluate the safety and effectiveness of novel therapies and provide practical information unattainable in trials.
The consensus expanded dataset includes items that address therapy effectiveness and safety and is collected in a multicenter, prospective, observational study, including SMA patients regardless of therapeutic status. The expanded dataset is aligned with global datasets to facilitate collaboration. Additionally, consensus dataset development aimed to standardize appropriate outcome measures across the network and broader Canadian community. Prospective outcome studies, data use, and analyses are independent of the funding partner.
Prospective outcome data collected will provide results on safety and effectiveness in a post-therapy approval era. These data are essential to inform improvements in care and access to therapy for all SMA patients.
In order to tackle the challenge of efficiently meeting clinical research accrual goals, many Clinical and Translational Science Award (CTSA) recipients have developed recruitment support mechanisms and resources to help investigators successfully recruit study participants. Disseminating recruitment best practices and developing collaborations between institutions can help strengthen recruitment capabilities and methodologies currently utilized by researchers.
To discover what recruitment resources and mechanisms CTSAs are using, the CTSA Recruitment and Retention working group developed an electronic survey, which was distributed to CTSAs between May and July 2019. The survey contained over 50 multiple choice and short answer questions, with 40 of the 64 CTSA institutions completing the survey. Institutions reported on registries, feasibility assessment tools, clinical trial listings, experience recruiting special populations, program operations and evaluation, workforce education, social media use, and other recruitment resources.
All respondents currently utilize some form of a volunteer registry; over 80% of the CTSAs provide investigators with recruitment consultations, feasibility assessments, study listings, and electronic health record (EHR) utilization; 73% assist with study materials; 47% offer social media assistance. Many institutions reported success in recruiting patients and healthy volunteers, but difficulty in recruiting special populations such as non-English-speaking persons and rural populations. Additional recruitment tools included use of the EHR to facilitate recruitment, use of registries, and use of social media to engage participants.
Areas of opportunity or growth include the development of innovative solutions in the areas of social media advertising, identification of participants from special populations, and research volunteer engagement.
Despite the well-known relevance of twin studies in the medical and social sciences and the growing number of twin registries throughout the world, Latin America has not fully incorporated into the twin research community. We describe the first steps taken toward developing a twin registry in Mexico: its aim, organization, recruiting potential and main short-term objectives.
The Swedish Twin Registry functions as research infrastructure containing information on 216,258 twins born between 1886 and 2015, of whom 86,199 pairs have zygosity determined by DNA, an intrapair similarity algorithm, or being of opposite sex. In essence, practically all twins alive and currently 9 years or older have been invited for participation and donation of DNA on which genomewide single nucleotide polymorphisms array genotyping has been performed. Content, management and alternatives for future improvements are discussed.
The Colorado Twin Registry (CTR) is a population-based registry formed from birth and school records including twins born between 1968 and the present. Two previous reports on the CTR [Rhea et al., (2006). Twin Research and Human Genetics, 9, 941–949; Rhea et al., (2013).Twin Research and Human Genetics, 16, 351–357] covered developments in the CTR through 2012. This report briefly summarizes previously presented material on ascertainment and recruitment and the relationships between samples and studies, discusses developments since 2012 for four previously described twin samples, describes two new samples and their complementary studies and expands on two subjects briefly mentioned in the last report: a history of genotyping efforts involving CTR samples, and a survey of collaborations and consortia in which CTR twins have been included. The CTR remains an active resource for both ongoing, longitudinal research and the recruitment of new twin samples for newly identified research opportunities.
The Mid-Atlantic Twin Registry (MATR) is a population-based registry of more than 60,000 twins primarily born or living in Virginia, North Carolina and South Carolina. Researchers may utilize the MATR for administration of research services, including study recruitment, data or sample (e.g., DNA) collection, archival dataset creation, as well as data collection through mailed, phone or online surveys. In addition, the MATR houses the MATR Repository, with over 1700 DNA samples primarily from whole blood available for researchers interested in DNA genotyping. For over 40 years MATR twins have participated in research studies with investigators from a range of scientific disciplines and institutions. These studies, which have resulted in numerous publications, explored diverse topics, including substance use, smoking behaviors, developmental psychopathology, bullying, children’s health, cardiovascular disease, cancer, the human microbiome, epigenetics of aging, children of twins and sleep homeostasis. Researchers interested in utilizing twins are encouraged to contact the MATR to discuss potential research opportunities.
IUI is often the first intervention offered for unexplained or mild to moderate male infertility and appears to be a safe method to prevent HIV transmission. Pregnancy and delivery rates per cycle remained stable for years. Factors influencing IUI results and studies evaluating if first line IVF rather than IUI could be a better option for couples with unexplained or mild male infertility will be discussed.
Increased risks compared to spontaneous conceptions have been described. However, data on comparison with IVF is limited and points to similar or lower perinatal risks. Multiple pregnancies are responsible for most of perinatal morbidities and are dependent on the use and aggressiveness of ovarian stimulation. Cost efficiency appears to be influenced by the indication, associated medications and perinatal complications mainly related to multiple pregnancies. While currently IUI with ovarian stimulation seems cost-effective, further studies are needed to confirm it in settings with advanced ART techniques.
ART was pioneered in Africa in the 1980’s. Subsequently, ART centres emerged around the continent, mostly by specialists acquiring skills abroad. Despite this, ART activity remains scant in most African countries and absent in several others.
Historically, ART surveillance in Africa has been similarly scant and fragmented. Recently however, the African Network and Registry for ART (ANARA) has been established with the vision to reduce the high burden of infertility in Africa through ART; and its mission to bring together ART centres within and across countries and to collect data pertaining to availability, utilization, effectiveness and safety of ART. First registry data, collected from 40 centres in 13 countries, and will be published shortly. ANARA protects the anonymity of centres and patients and the ownership of data.
The successful establishment of ANARA is rooted in a collaborative spirit of engagement with ART centres and other stakeholders, developmental assistance from both the Latin American and World Registry, and the importance of data in reducing the burden of infertility in Africa.
Asia is composed of more than 40 countries where about 60% of the global population live. Since Asia is the largest and geographically variable continent, where cultural and social backgrounds are very diverse in every part of this area, it is almost impossible to describe the whole area in one chapter. Rapid decline of birth rates in multiple countries, particularly in eastern Asia, drew wide public attention and promoted the treatment and care for infertile couples. Particularly, assisted reproductive technology (ART) has significantly spread in many Asian countries and its growth is still ongoing. Although ART registries were established in several Asian countries many years ago, there is no Asian regional registry because of this diverse situation of this area.
Nation-specific registries of ART treatments were established in the United States, Canada, and Mexico in 1985, 1999 and 1995 respectively. In the United States, reporting became mandatory in 1992, and 94% of nearly the 500 clinics report. In Canada, reporting is voluntary and all but one clinic is currently reporting. In Mexico, a small proportion (about 20%) of over 50 clinics report to their country’s registry. Initially these registries contained summaries of each clinic’s overall outcomes, but all have now become cycle-specific. While all registries have systems in place to ensure quality of data, prospective reporting and annual data validations are mandatory only in the United States. All registries have adjusted their online data collections systems to capture changes in clinical practice patterns. Clinic-specific ART reports are available online in all North American countries. Information from these registries has been valuable for research and to develop treatment guidelines; most significantly, guidelines regarding the number of embryos to transfer has led to a dramatic reduction in multiple pregnancy rates.