Using Active Learning Methods, Adult Learning Principles and the Identification of Critical to Quality (CTQ) Factors to Create Effective Site Staff Training Plans and Improve Quality Risk Management

Objective: The objective of this poster presentation is to help sponsors, monitors and clinical research site managers design and conduct more meaningful and effective site staff training activities in order to enhance the implementation of study protocols in accordance with the investigational plan and thus improve quality risk management. Content: The U.S. Food and Drug Administration (FDA), the International Council on Harmonization (ICH) and the European Medicines Agency (EMA) emphasize that sponsors should choose investigators, clinical research site staff and monitors that are qualified by education, training and experience. In addition, these entities have taken a more risk-based approach to managing and monitoring risks in recent years. This approach consists of focusing oversight on the risks related to human subjects protection, data integrity and investigation quality. All processes used to prevent and mitigate risks should be in direct proportion to the seriousness and likelihood of these risks. The ICH E6 (R2) noted that effective training in processes and procedures is one of the risk reduction activities that sponsors should employ. FDA’s 2013 guidance on risk-based monitoring noted that investigators and clinical research site staff need “meaningful training” prior to and during the conduct of a study in order to execute it correctly. In FY 2017, the most frequent finding on FDA Form 483 that was issued from inspections by FDA’s Bioresearch Monitoring Program was failure to conduct the investigation in accordance with the investigational plan. A common citation noted in warning letters to sponsors and investigators was the failure to have effective training and retraining activities. The challenge, therefore, is to design and conduct training activities that are meaningful and effective in order to correctly execute study protocols and reduce risks to human subjects protection, data integrity and investigation quality. Educational research has shown that active learning methods are much more effective at enhancing knowledge transfer and retention than passive learning methods such as reading, listening or watching a webcast. In this poster presentation, I will discuss various active learning methods that can be used to design and conduct meaningful and effective site training activities. I will discuss how these methods can be combined with adult learning principles and risk identification/assessment tools to design a site staff training plan that will identify the Critical to Quality (CTQ) factors, enhance the prevention and mitigation of risks that matter, and help staff to execute the study protocol in accordance with the investigational plan

Medication Adherence and its Implications for Clinical Research: An Example from Low Income, Urban Young Adults Living with HIV/AIDS

Consistent medication adherence by study participants is essential for producing valid and reliable safety and efficacy data in clinical trials. Adherence to investigational medications can be a challenge, particularly for study participants who have complex medication regimens, a stigmatized illness such as HIV/AIDS or a mental health disorder, and risk factors for poor adherence such as young or old age, poor health status, cognitive issues, low health literacy, and low socioeconomic status. A deep understanding of the study population’s beliefs, attitudes, motivations, and prior experiences regarding medication adherence can assist clinical research professionals with predicting medication adherence potential during the recruitment phase along with supporting medication adherence during the study conduct phase. I will present excerpts from in-depth interviews with 16 low income, urban young adults living with HIV/AIDS about their beliefs, attitudes, motivations, and prior experiences about medication adherence. I will discuss how this information can be used by clinical research professionals who conduct clinical trials with this population to predict and support medication adherence. I will also discuss how collecting deep, rich qualitative data about the study population can assist the clinical research team with predicting and supporting medication adherence of study participants. This presentation will be of interest to clinical research professionals who conduct clinical trials with low income, urban young adults living with HIV/AIDS as well as for those interested in predicting and supporting medication adherence among study participants in general

Precision health: A nursing perspective

Precision health refers to personalized healthcare based on a person's unique genetic, genomic, or omic composition within the context of lifestyle, social, economic, cultural and environmental influences to help individuals achieve well-being and optimal health. Precision health utilizes big data sets that combine omics (i.e. genomic sequence, protein, metabolite, and microbiome information) with clinical information and health outcomes to optimize disease diagnosis, treatment and prevention specific to each patient. Successful implementation of precision health requires interprofessional collaboration, community outreach efforts, and coordination of care, a mission that nurses are well-positioned to lead. Despite the surge of interest and attention to precision health, most nurses are not well-versed in precision health or its implications for the nursing profession. Based on a critical analysis of literature and expert opinions, this paper provides an overview of precision health and the importance of engaging the nursing profession for its implementation. Other topics reviewed in this paper include big data and omics, information science, integration of family health history in precision health, and nursing omics research in symptom science. The paper concludes with recommendations for nurse leaders in research, education, clinical practice, nursing administration and policy settings for which to develop strategic plans to implement precision health

Improving validity of informed consent for biomedical research in Zambia using a laboratory exposure intervention.

BACKGROUND: Complex biomedical research can lead to disquiet in communities with limited exposure to scientific discussions, leading to rumours or to high drop-out rates. We set out to test an intervention designed to address apprehensions commonly encountered in a community where literacy is uncommon, and where complex biomedical research has been conducted for over a decade. We aimed to determine if it could improve the validity of consent. METHODS: Data were collected using focus group discussions, key informant interviews and observations. We designed an intervention that exposed participants to a detailed demonstration of laboratory processes. Each group was interviewed twice in a day, before and after exposure to the intervention in order to assess changes in their views. RESULTS: Factors that motivated people to participate in invasive biomedical research included a desire to stay healthy because of the screening during the recruitment process, regular advice from doctors, free medical services, and trust in the researchers. Inhibiting factors were limited knowledge about samples taken from their bodies during endoscopic procedures, the impact of endoscopy on the function of internal organs, and concerns about the use of biomedical samples. The belief that blood can be used for Satanic practices also created insecurities about drawing of blood samples. Further inhibiting factors included a fear of being labelled as HIV positive if known to consult heath workers repeatedly, and gender inequality. Concerns about the use and storage of blood and tissue samples were overcome by a laboratory exposure intervention. CONCLUSION: Selecting a group of members from target community and engaging them in a laboratory exposure intervention could be a useful tool for enhancing specific aspects of consent for biomedical research. Further work is needed to determine the extent to which improved understanding permeates beyond the immediate group participating in the intervention

Somatosensory System Deficits in Schizophrenia Revealed by MEG during a Median-Nerve Oddball Task

Although impairments related to somatosensory perception are common in schizophrenia, they have rarely been examined in functional imaging studies. In the present study, magnetoencephalography (MEG) was used to identify neural networks that support attention to somatosensory stimuli in healthy adults and abnormalities in these networks in patient with schizophrenia. A median-nerve oddball task was used to probe attention to somatosensory stimuli, and an advanced, high-resolution MEG source-imaging method was applied to assess activity throughout the brain. In nineteen healthy subjects, attention-related activation was seen in a sensorimotor network involving primary somatosensory (S1), secondary somatosensory (S2), primary motor (M1), pre-motor (PMA), and paracentral lobule (PCL) areas. A frontal–parietal–temporal “attention network”, containing dorsal- and ventral–lateral prefrontal cortex (DLPFC and VLPFC), orbitofrontal cortex (OFC), anterior cingulate cortex (ACC), superior parietal lobule (SPL), inferior parietal lobule (IPL)/supramarginal gyrus (SMG), and temporal lobe areas, was also activated. Seventeen individuals with schizophrenia showed early attention-related hyperactivations in S1 and M1 but hypo-activation in S1, S2, M1, and PMA at later latency in the sensorimotor network. Within this attention network, hypoactivation was found in SPL, DLPFC, orbitofrontal cortex, and the dorsal aspect of ACC. Hyperactivation was seen in SMG/IPL, frontal pole, and the ventral aspect of ACC in patients. These findings link attention-related somatosensory deficits to dysfunction in both sensorimotor and frontal–parietal–temporal networks in schizophrenia

Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study

Funder: European Society of Intensive Care Medicine; doi: http://dx.doi.org/10.13039/501100013347Funder: Flemish Society for Critical Care NursesAbstract: Purpose: Intensive care unit (ICU) patients are particularly susceptible to developing pressure injuries. Epidemiologic data is however unavailable. We aimed to provide an international picture of the extent of pressure injuries and factors associated with ICU-acquired pressure injuries in adult ICU patients. Methods: International 1-day point-prevalence study; follow-up for outcome assessment until hospital discharge (maximum 12 weeks). Factors associated with ICU-acquired pressure injury and hospital mortality were assessed by generalised linear mixed-effects regression analysis. Results: Data from 13,254 patients in 1117 ICUs (90 countries) revealed 6747 pressure injuries; 3997 (59.2%) were ICU-acquired. Overall prevalence was 26.6% (95% confidence interval [CI] 25.9–27.3). ICU-acquired prevalence was 16.2% (95% CI 15.6–16.8). Sacrum (37%) and heels (19.5%) were most affected. Factors independently associated with ICU-acquired pressure injuries were older age, male sex, being underweight, emergency surgery, higher Simplified Acute Physiology Score II, Braden score 3 days, comorbidities (chronic obstructive pulmonary disease, immunodeficiency), organ support (renal replacement, mechanical ventilation on ICU admission), and being in a low or lower-middle income-economy. Gradually increasing associations with mortality were identified for increasing severity of pressure injury: stage I (odds ratio [OR] 1.5; 95% CI 1.2–1.8), stage II (OR 1.6; 95% CI 1.4–1.9), and stage III or worse (OR 2.8; 95% CI 2.3–3.3). Conclusion: Pressure injuries are common in adult ICU patients. ICU-acquired pressure injuries are associated with mainly intrinsic factors and mortality. Optimal care standards, increased awareness, appropriate resource allocation, and further research into optimal prevention are pivotal to tackle this important patient safety threat

Correction to: Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study

The original version of this article unfortunately contained a mistake