Receipt Of Notification Research Articles

Research ethics committees and post-approval activities: a qualitative study on the perspectives of European research ethics committee representatives

Objective To explore the views of Research Ethics Committee (REC) representatives in the European Union (EU) on what the status quo is in terms of RECs’ activities after the approval of trial protocols for clinical studies. Method This is a qualitative study. The participants in this study are members or representatives of a research ethics committee from the member countries of the European Network of Research Ethics Committees (EUREC) and the United Kingdom. Thematic analysis was the method to assess interview transcripts. Results Interviews of REC representatives from 19 countries across Europe reveals that REC post-approval activities are predominantly limited to review and approval of protocol amendments. The majority of the RECs do not have mandatory continuing reviews or receipt of notifications of adverse events or protocol violations. In fact, most post-approval activities are the remit of the regulatory authorities. The interviewed members were also of the opinion that RECs in the EU do not have the legislative support, the organizational structure, the expert staff nor time to do active post approval follow-up. Conclusions Post-approval follow-up activities for clinical studies by RECs is a valuable resource and means for early detection and resolution of protocol deviations and violations. However, a majority of RECs within Europe do not have active post-approval follow-up of approved protocols. The interviews revealed that resource challenges such as time, personnel, and organizational structure contribute to the lack of follow-up by RECs. Some RECs in the represented countries do not identify post-approval follow-up as part of their mandate but instead place emphasis on the culture of trust between the RECs and researchers. Current EU Regulations do not directly address the role of the REC after the approval of clinical trials.

Public Reporting of Adverse Events From Long-Term Care Facilities for Older Persons and People With Disability in Ireland 2013-2019: Development of an Openly Accessible Database and Descriptive Analyses.

To describe the development of an analyzable database of statutory notifications received from long-term care facilities (LTCFs) and to describe trends in receipt of notifications from 2013 to2019. Description of database development with descriptive and trend analyses. LTCFs for older persons and for people with disability in Ireland. Data on notifications received and on centers were extracted from a system internal to the health and social services regulator and combined into an analyzable database. Variables were screened for personal information, cleaned, transformed, or redacted and combined into a database suitable for open access publication. Descriptive analyses of the volume of notifications, trends over time and breakdown by service type, notification type, and risk-rating were conducted. The Database of Statutory Notifications from Social Care in Ireland was developed and an open access version published in February 2021. Protection of personal data was an important consideration in publishing the data publicly. Uses of the database include examination of national trends and identification of determinants of adverse events and areas for quality improvement. The number of notifications received increased over time. Quarterly notifications contributed to the largest proportion of notifications (older persons, 36.7%; disability, 39.1%). This was followed by serious injury notifications in LTCFs for older persons (33.3%) and abuse allegation notifications in LTCFs for people with disability (36.0%). Less than 1% of individual notifications were risk-rated red (highest severity level of impact on resident welfare). The types of notifications that were collectively risk-rated highest were staff misconduct, abuse allegations, and outbreaks of infectious disease. The methodology and findings can inform publications of notifications, planning and resourcing for receipt and submission of notifications, target areas for quality improvement initiatives, mandating of timelines for receipt of notifications, and the mandating of notifications in legislation.

Editor's Choice: Deliberative and non-deliberative effects of descriptive and injunctive norms on cancer screening behaviors among African Americans

Objective: Two longitudinal studies examined whether effects of subjective norms on secondary cancer prevention behaviors were stronger and more likely to non-deliberative (i.e., partially independent of behavioral intentions) for African Americans (AAs) compared to European Americans (EAs), and whether the effects were moderated by racial identity. Design: Study 1 examined between-race differences in predictors of physician communication following receipt of notifications about breast density. Study 2 examined predictors of prostate cancer screening among AA men who had not been previously screened.Main Outcome Measures: Participants’ injunctive and descriptive normative perceptions; racial identity (Study 2); self-reported physician communication (Study 1) and PSA testing (Study 2) behaviors at follow up. Results: In Study 1, subjective norms were significantly associated with behaviors for AAs, but not for EAs. Moreover, there were significant non-deliberative effects of norms for AAs. In Study 2, there was further evidence of non-deliberative effects of subjective norms for AAs. Non-deliberative effects of descriptive norms were stronger for AAs who more strongly identified with their racial group. Conclusion: Subjective norms, effects of which are non-deliberative and heightened by racial identity, may be a uniquely robust predictor of secondary cancer prevention behaviors for AAs. Implications for targeted screening interventions are discussed.

Federally Qualified Health Center Strategies for Integrating Care with Hospitals and Their Association with Measures of Communication

Federally qualified health centers have aligned clinical services and systems with local hospitals, but little is known about the specific care integration strategies health centers use or their impact on care. A research team examined the use of strategies by health centers to integrate care with hospitals and emergency departments (EDs) and their association with performance on measures of health center-hospital communication. A Web-based survey was administered to health center medical directors in 12 states and Washington, DC, in 2017. The survey collected 10 self-reported measures of communication between health centers and hospitals/EDs and the extent to which health centers used different strategies to improve care integration. Health center and market characteristics that predict higher vs. lower integration activity were examined, and logistic regression was used to assess the relationship between integration activity and communication. Between 56% and 81% of health centers participated in quality improvement projects, health promotion initiatives, guideline alignment, or executive meetings with hospitals; far fewer established notification agreements regarding hospital/ED utilization. Health centers that were larger, were located in rural areas or states with Accountable Care Organization programs, reported fewer staff shortages, and had fewer minority patients were associated with greater integration activity. Higher levels of integration activity were associated with better performance on most communication measures in both inpatient and ED settings (p < 0.05). Integration activity was not associated with health centers' receipt of notifications after patients' ED visits. Health centers differ in the use of strategies to integrate care with hospitals. Overall, integration activity is associated with better communication.

ES02.01 Expanding PROs in Daily Practice

ES02.01 Expanding PROs in Daily Practice

Evaluation of the Completeness and Timeliness of National Malaria Surveillance System in Qatar, 2016.

BackgroundThe high influx of migrant workers from malaria-endemic countries along with the presence of a malaria vector in Qatar has raised the alarm of the possible reintroduction of local transmission. Meanwhile, the Qatar Malaria Surveillance System aims to detect any local malaria transmission as well as to monitor trends in imported cases.AimEvaluating the attributes of the Malaria Surveillance System in Qatar will help identify any gaps necessitating rectification.MethodThe completeness and timeliness of the malaria surveillance system were determined. The direct method was used to determine completeness. Timeliness was evaluated by calculating the time lag between the onset of disease and notification receipt by the surveillance team (T) or diagnosis (T1) and between the diagnosis and receipt of notification by the surveillance team (T2).ResultsThe overall external completeness of Malaria surveillance system was yielded at 47% (219/493). The most frequently reported data fields were found to be age, gender, and nationality with a percentage of 99% or more. However, the least reported data components were found to be lab results, types of samples, sample collection, and travel destinations with percentages of 59%, 58%, 56%, and 41%, respectively.The overall median time lags was six days for T, four days for T1, and two days for T2.ConclusionOur study has identified several merits and areas of improvement in the National Malaria Surveillance System in Qatar. The attributes of evaluation, completeness and timeliness, need more quality improvement. Evaluation of other surveillance system attributes is highly recommended.

The impacts of email reminder/recall on adolescent influenza vaccination

BackgroundWe sought to: (1) explore the feasibility of using email for seasonal influenza vaccination reminders to parents of adolescents and (2) assess influenza vaccination rates among adolescents whose parents were randomized to either receive or not receive email reminders. MethodsEmail addresses were obtained for parents of patients 10–18years from 4 practices in Michigan. Addresses were randomized to either receive email reminders, or not. Reminder messages were sent during October 2012-March 2013 (Season 1) and October 2013-March 2014 (Season 2). Vaccination status was determined 60days following the last email reminder for each season using the statewide Michigan Care Improvement Registry (MCIR); per protocol bivariate and multivariate logistic regression analyses were conducted to evaluate reminder notification. ResultsAfter email cleaning, testing, and matching with MCIR, approximately half of email addresses (2348 of 5312 in Season 1; 3457 of 6549 in Season 2) were randomized. Bivariate analyses found that influenza vaccination within 60days after notification date was similar among those notified (34%) versus not notified (29%) in both Season 1 (p=0.06) and Season 2 (39% vs. 37%, p=0.20). However, multivariate models adjusted for season, site, and receipt of notification in two seasons found a higher likelihood of influenza vaccination among children that received notification (aOR=1.28, 95% CI=1.09, 1.51); in addition, differences in influenza vaccination were also observed between practice sites (range: p=0.15 to p<0.001). ConclusionsWe found that practice-based email influenza vaccine reminders to parents of adolescents are feasible, but not without complications. Our study demonstrates that email reminders from practices can yield increases in influenza vaccination rates among adolescents. Practices should consider email as an option for influenza reminders and establish business practices for collecting and maintaining patient email addresses.This study is registered at www.ClinicalTrials.gov id #NCT01732315.

An increasing trend in health-care professionals notifying children of unhealthy weight status: NHANES 1999-2014.

Pediatric obesity prevalence remains at historically high levels. The objective of this study was to examine secular trends in the percentages of overweight/obese children who received notification from a health-care professional (HCP) about their unhealthy weight. We analyzed data of 25 570 (including 8639 overweight/obese) children aged 2-18 years collected from seven cross-sectional biennial surveys (National Health and Nutrition Examination Survey, 1999-2014), in which adolescents (16 years and older) and caregivers, mostly biological mothers, of children (2-15 years) were asked 'Has a doctor or other health professional ever told you that you (or your child) were overweight?' Approximately 90% of overweight/obese children visited HCPs at least once in the past 12 months, but only 22.12% (s.e.=1.92) in 1999 to 34.43% (2.35) in 2014 of the overweight/obese children were notified by HCPs about unhealthy weight. The biennial increase in odds of receipt of notification of unhealthy weight was 1.08 (95% confidence interval=(1.04-1.12)). Greater likelihood for receipt of notification was associated with being obese (odds ratio=5.03 (4.29-5.89) vs overweight); black (1.24 (1.06-1.46)) or Hispanic race/ethnicity (1.72 (1.45-2.04) vs white); female sex (1.22 (1.07-1.11) vs boys); and child's insurance status (1.31 (1.08-1.59) vs uninsured). There were increasing odds of being notified with increasing age: 1.00 (reference), 2.24 (2.06-2.62), 3.22 (2.50-4.13) and 4.87 (3.76-6.32) for children 2-5, 6-11, 12-16 and 16+ year old, respectively. The frequency of medical contact was linearly associated with an increased likelihood of being notified. Notification of child's unhealthy weight by HCPs increased significantly between 1999 and 2014, but the opportunity of clinical intervention remained substantially under-utilized.

Hydrogen ions instead minutes: The Initial pH level may predict survival without neurological impairment in the not witnessed prehospital cardiac arrest

Objective: To analyze the possible association of venous pH values collected in blood sample at the beginning of resuscitation and neurological recovery (CPC I-II). Methodology: Prospective analytical study in adult patients withnon-traumatic cardiac arrest attendedbyEMSwithphysicians on scene during 2012–2013. Inclusion Criteria: Prehospital Cardiac arrest not witnessed. Exclusion Criteria: traumatic-cardiac arrest. Variables: venous pH, time from onset of OOHCA until arrival first EMS unit, rate of spontaneous circulation recovery (REC)and REC time, rate of survival without neurological impairment (CPC I–II) during the first year. Statistical quantitative: Central and DispersionMeasures. Qualitative: percentages. Pearson correlation. Curve COR. ACCES, Excel, SPSS: v17. Data confidentiality. Results: 454 non-traumatic prehospital cardiac arrests. 94% (427) had analytical register. The average time from receipt of notification to obtain the blood sample was 12min (IQR: 9–14). There’s an inverse association between levels of pH and time of obtaining the blood sample (p=0.007). The prevalence of patients with neurologic recovery ad integrum was 20.14%. Initial pH was also associated to arrival time. Ph levels below 6.77 were associatedwith 100%mortality. RECwas not associatedwith initial pH (p=0.48). However, the initial pH was associated with survival without neurological impairment (CPC I–II) (p=0.001). The interval (7.09–7.25) was associated with improved survival. The initial pH above 7.06 had 82% specificity for predicting recovery ad integrum and positive predictive value of 89%. Initial pH values greater than 7.06 were associated with survival (CPC I–II) OR=3.027 (95% CI 1.6 to 5.5).

Factors associated to the survival in pre-hospital Sudden Cardiac Arrest

Objective: To analyze the possible association of venous pH values collected in blood sample at the beginning of resuscitation and neurological recovery (CPC I-II). Methodology: Prospective analytical study in adult patients withnon-traumatic cardiac arrest attendedbyEMSwithphysicians on scene during 2012–2013. Inclusion Criteria: Prehospital Cardiac arrest not witnessed. Exclusion Criteria: traumatic-cardiac arrest. Variables: venous pH, time from onset of OOHCA until arrival first EMS unit, rate of spontaneous circulation recovery (REC)and REC time, rate of survival without neurological impairment (CPC I–II) during the first year. Statistical quantitative: Central and DispersionMeasures. Qualitative: percentages. Pearson correlation. Curve COR. ACCES, Excel, SPSS: v17. Data confidentiality. Results: 454 non-traumatic prehospital cardiac arrests. 94% (427) had analytical register. The average time from receipt of notification to obtain the blood sample was 12min (IQR: 9–14). There’s an inverse association between levels of pH and time of obtaining the blood sample (p=0.007). The prevalence of patients with neurologic recovery ad integrum was 20.14%. Initial pH was also associated to arrival time. Ph levels below 6.77 were associatedwith 100%mortality. RECwas not associatedwith initial pH (p=0.48). However, the initial pH was associated with survival without neurological impairment (CPC I–II) (p=0.001). The interval (7.09–7.25) was associated with improved survival. The initial pH above 7.06 had 82% specificity for predicting recovery ad integrum and positive predictive value of 89%. Initial pH values greater than 7.06 were associated with survival (CPC I–II) OR=3.027 (95% CI 1.6 to 5.5).

A Three-Decade History of the Duration of Peer Review

Review time is the duration between submission of a manuscript for possible publication and the author's receipt of notification of the editor's decision. There are two key questions about the peer-review process: (1) Has average review time changed over the past several decades? and (2) Has the adoption of online submission reduced average review time? A sample of 170 manuscripts submitted to a variety of journals from 1980 through 2012 indicates (1) no statistically significant difference between average review time for manuscripts submitted to behavioural science journals (mean=14.8 weeks) and average review time for manuscripts submitted to natural history journals (mean=15.2 weeks); (2) a statistically significant decrease from 1980 to 2012 in average review time irrespective of form of submission (i.e., paper or electronic); and (3) manuscripts submitted in paper form (1980–2009) had an average review time five weeks longer than that of manuscripts submitted online or electronically (2004–2012).

Foodborne disease surveillance in NSW: moving towards performance standards.

NSW Health has sole responsibility for the surveillance of foodborne disease in humans, through the receipt of notifications for a range of conditions that are predominantly or potentially foodborne in transmission. These conditions include: salmonellosis, listeriosis, shigellosis, typhoid, Verotoxin producing E. coli infection, cholera, hepatitis A, giardiasis, and cryptosporidiosis. In addition, outbreaks of foodborne disease affecting two or more people are notifiable. Surveillance methods used in NSW are described in detail in this issue of the NSW Public Health Bulletin by Neville and McAnulty. This article describes the evolution of, and recent investments in, foodborne disease surveillance and control in NSW, and discusses the opportunities to produce measurable enhancements to food safety from these investments.

Randomised controlled trial assessing the impact of increasing information to health visitors about children's injuries

AIMSTo assess the effect on health visitor action of providing community health visitors with information on all injury attendances in children under 5 attending an accident and emergency (A&E) department...

US INTERNET SERVICE PROVIDER LIABILITY: ISP: YOU’VE GOT MAIL — AND IGNORING IT COULD BY-PASS THE SAFE HARBOR OF THE DMCA

The Digital Millennium Copyright Act (DMCA) added a safe harbor provision shielding an Internet service provider (ISP) from liability for copyright infringement under certain circumstances. The effectiveness of the safe harbor defence depends on what the ISP does upon receipt of notification of copyright infringing activity from a copyright owner. In a recent Court of Appeals decision (ALS Scan Inc. v RemarQ Communities Inc. (Case No. 00-1351, United States Court of Appeals, 4th Circuit, 6 February 2001)), one ISP learned that a failure to respond properly and expeditiously to even an imperfect DMCA notification is at the ISP’s peril. Alan Wernick reports on the decision and its implications.

Workplace Preparedness and the Americans with Disabilities Act: Lessons from Municipal Governments' Management of HIV/AIDS

Although the 1990 Americans with Disabilities Act (ADA) is designed to protect all disabled individuals from workplace discrimination, its mission is somewhat more difficult to accomplish in situations involving employees and job applicants who are either infected with the human immunodeficiency virus (HIV) or have developed Acquired Immunodeficiency Syndrome (AIDS). Concomitant social and cultural dimensions of this disease quite often make people with HIV/AIDS believe that it is perilous for them to stand up and disclose their condition, a prerequisite for protection and assistance under the act.(1) Given the prejudice that can accompany HIV/AIDS, a supervisor might weigh the risk to his or her career in assisting members of this protected group when doing so may result in opposition from key sources within the workplace hierarchy and throughout the community. Upon receipt of notification and documentation that an individual has HIV/AIDS, workplace must protect the rights of that job applicant or employee. It is the law. The need for organizational action, moreover, increases with the rising rate of HIV infection in the United States.(2) Protecting HIV-challenged individuals from workplace discrimination involves two kinds of actions on the part of organizations: meeting the job-related needs of members of this disabled group and building a workplace environment that encourages and supports the self-disclosure which the act requires. The purpose of this study is to assess the extent to which organizations, municipal governments specifically, are prepared to carry out these two highly interrelated tasks. Dimensions of the Study Three kinds of workplace responsiveness to HIV/AIDS situations are examined here: (1) HIV/AIDS-related activities and programs, (2) reasonable accommodations that are made available to employees with HIV/AIDS, and (3) reasonable accommodations that are made available for job applicants with HIV/AIDS. These are the dependent variables in this study. I also look at three sets of factors, independent variables, which can play substantial roles in determining the nature and extent of organizational responsiveness. The first factor focuses on personal characteristics of chief administrative officers (CAOs). We sometimes forget that consist of people and that people determine the organizational culture. While much of workplace cultures are historically based, it remains true that leaders influence the development and expression of culture in their organizations (Trice and Beyer, 1993; 255). They can play a significant part in the processes of sustaining or modifying existing cultures, and they can use their positions to transform the workplace environment into something totally different. Within the work setting, therefore, CAOs have the power to initiate changes that can lead to differences in organizational attitude and behavior. The role played by individuals in shaping organizational responses is also noted throughout the policy implementation literature (Pressman and Wildavsky, 1973; Van Meter and Van Horn, 1975; Yinger, 1990). Within the framework of American federalism, the best laid plans of Washington can either be accomplished or thwarted by actions and nonactions, formal and informal behavior, of people in Boston or Bakersfield. This is especially true in the case of antidiscrimination policies (Bullock and Lamb, 1984), such as those involving school desegregation (Rodgers and Bullock, 1976) or protected group integration into the work force (Saltzstein, 1986). Unfortunately, it is with these kinds of policies that interpretations with controversial, threatening, or even zero-sum consequences appear much more readily available. CAOs play a role in interpreting potential policy consequences for the workplace. The second factor focuses on two dimensions of the organization's environment: background demographics and local politics. …

Diphtheria in a welfare home.

This paper reports the steps taken on receipt of notification of a case of diphtheria in a welfare home, and discusses the use of the Schick test when the immunity status of the inmates of the home is unknown.