Non-clinical Setting Research Articles

Automated Detection of Symptomatic Autonomic Dysreflexia Through Multimodal Sensing.

Objective: Autonomic Dysreflexia (AD) is a potentially life-threatening syndrome which occurs in individuals with higher level spinal cord injuries (SCI). AD is caused by triggers which can lead to rapid escalation of pathophysiological responses and if the trigger is not removed, AD can be fatal. There is currently no objective, non-invasive and accurate monitoring system available to automatically detect the onset of AD symptoms in real time in a non-clinical setting. Technology or Method: We developed a user-independent method of symptomatic AD detection in real time with a wearable physiological telemetry system (PTS) and a machine learning model using data from eleven participants with SCI. Results: The PTS could detect onset of AD symptoms with an average accuracy of 94.10% and a false negative rate of 4.89%. Conclusions: The PTS can detect the onset of the symptoms AD with high sensitivity and specificity to assist people with SCIs in preventing the occurrence of AD. It would enable persons with high level SCIs to be more independent and pursue vocational activities while granting continuous medical oversight. Clinical Impact: The PTS could serve as a supplementary tool to current solutions to detect the onset of AD and prepare individuals who are newly injured to be better prepared for AD episodes. Moreover, it could be translated into a system to encourage individuals to practice better healthcare management to prevent future occurrences.

Genital Psoriasis and Associated Factors of Sexual Avoidance - A People-centered Cross-sectional Study in Germany.

Patients with genital psoriasis show poorer outcomes regarding quality of life and sexual distress than those without. This study aimed to assess the occurrence of genital psoriasis and to determine factors associated with the avoidance of sexual activities due to psoriasis in a non-clinical setting. A cross-sectional, person-centered, and online-based nationwide survey was conducted in Germany between March and June 2019. A multiple logistic regression model was used to analyze the data. Furthermore, free-text answers were provided. Overall, 344 individuals with psoriasis participated. Of these, 198 (57.6%) reported having genital psoriasis and 261 (75.9%) currently received medical care. Duration of psoriasis, subjective overall severity, and pain during sex were associated with the avoidance of sexual activities. Most prevalent reasons to avoid sexual activities were ‘shame,’ ‘pain,’ and ‘fear of rejection.’ Sexual distress was high in this sample and a person-centered care approach needs to be further promoted.

Measurement properties of Portuguese-Brazil Western Ontario and McMaster Universities osteoarthritis index (WOMAC) for the assessment of knee complaints in Brazilian adults: ELSA-Brasil Musculoskeletal cohort.

Information on measurement properties of translated versions of the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index is still limited. This study investigated the internal consistency, test-retest reliability/agreement, construct validity, and floor and ceiling effects of Portuguese-Brazil WOMAC applied to civil servants at baseline of ELSA-Brasil Musculoskeletal cohort. Each measurement property was evaluated in the overall sample, in the subgroup reporting knee symptoms, and across different sociodemographic strata (except factorial analyses). Separate analyses were performed for pain, stiffness and function dimensions, considering the knee with the worst score (or right knee if same score in both knees). A total of 1740 participants were included (319 completed WOMAC on 2 occasions), mean age 56.0 (standard deviation = 8.9) years, 46.8% male, 42.1% had knee symptoms. In the overall sample, the range of results for WOMAC's dimensions were: internal consistency = cronbach alpha 0.92-0.98; test-retest reliability = intraclass correlation coefficient 0.85-0.97; standard error of measurement (SEM) = 1.38-5.86; smallest detectable change (SDC) = 3.84-16.25; lowest possible score = 38.8%-61.1% (floor effect present); highest possible score = 0.2%-0.9% (ceiling effect absent). Construct validity was confirmed by hypothesis testing and factorial analysis. Results were similar in the symptomatic group, except for higher SEM and SDC, and the absence of floor effects in pain and function dimensions. Portuguese-Brazil WOMAC showed good overall quality in a nonclinical setting. Variability in measurement properties across different strata of the population should be taken into consideration for the design of future studies using WOMAC.

Use of Maintenance Therapy Post Autologous Stem Cell Transplantation Outside of Clinical Trial Setting for Multiple Myeloma: Single Institution Experience

Background: Based on results from the phase 3 trials, maintenance therapy after autologous stem cell transplantation has become the standard of care. While lenalidomide is typically used as the maintenance agent, patients with high risk MM are often maintained on proteasome inhibitor-based maintenance treatment. We examined the trends in maintenance use and outcomes in a large group of patients transplanted at a single institution over two decades spanning the years when maintenance gradually became standard of care. Methods: We included patients who underwent their first autologous stem cell transplantation between 2000 and 2016 in the current study. Patients who received an allogeneic SCT or a planned tandem SCT were excluded. Clinical data was extracted from the medical records or from a prospectively maintained database. Early transplant was defined as SCT within 12 months of diagnosis. High risk (HR) myeloma was defined as per IMWG criteria, based on presence of high-risk FISH abnormalities. Progression free survival and overall survival were estimated from either diagnosis as well as from the date of SCT. Results: We included 1961 patients with MM who were transplanted between January 2000 and August 2016 in the current analysis. Majority (n=1496; 76%) had an early SCT while the remaining patients were transplanted beyond 12 mos from diagnosis. Maintenance was employed in 31% of the patients, 33% of the early SCT and 23% of the delayed SCT. Proportion of patients receiving maintenance increased over the years: <1% in 2000 to 85% in 2016. The most common maintenance approach was an IMiD (56%), followed by a PI (33%) and a PI+IMiD (8%). FISH risk was available in 875 patients, all assessed within 6 months of diagnosis, and 22% were HR. Overall, maintenance was more commonly used in HR patients (64% vs. 36%), and a PI containing maintenance was more commonly used in HR (42% vs. 12%). The PFS was superior for those receiving a maintenance therapy (70 vs. 23 mos, P<0.001); NR vs. 27 mos for early SCT and 25 vs. 16 mos for delayed SCT. The impact of maintenance therapy was more evident in the HR group HR vs SR risk ratio was 2.3 without maintenance, and 1.5 with maintenance. Among the HR patients, PI based maintenance had a trend towards better outcome, while the PFS was better with non-PI maintenance among the SR patients. OS from diagnosis was also better among the early SCT group who received maintenance (99 vs. 88 mos; p=0.01); however, the OS advantage appeared most evident among the HR patients. Conclusions: The experience with maintenance therapy post autologous SCT for myeloma in a non-clinical trial setting appear to confirm the findings from the phase 3 trials. Maintenance provided benefit in patients who had a delayed SCT in our experience. The benefit appear to be particularly relevant for high risk patients, who appear to benefit from PI based regimens. In contrast, SR patients appear to benefit primarily from IMiD based regimen. Disclosures Gertz: Spectrum: Consultancy, Research Funding; Johnson and Johnson: Speakers Bureau; Amgen: Consultancy; Ionis/Akcea: Consultancy; Research to Practice: Consultancy; Appellis: Consultancy; Celgene: Consultancy; Teva: Speakers Bureau; Alnylam: Consultancy; Janssen: Consultancy; Annexon: Consultancy; Abbvie: Other: personal fees for Data Safety Monitoring board; Medscape: Consultancy, Speakers Bureau; Prothena Biosciences Inc: Consultancy; Physicians Education Resource: Consultancy. Lacy:Celgene: Research Funding. Dispenzieri:Akcea: Consultancy; Intellia: Consultancy; Janssen: Consultancy; Pfizer: Research Funding; Takeda: Research Funding; Celgene: Research Funding; Alnylam: Research Funding. Dingli:Millenium: Consultancy; Rigel: Consultancy; Janssen: Consultancy; alexion: Consultancy; Karyopharm: Research Funding. Kapoor:Amgen: Research Funding; Takeda: Honoraria, Research Funding; Glaxo Smith Kline: Research Funding; Celgene: Honoraria; Janssen: Research Funding; Cellectar: Consultancy; Sanofi: Consultancy, Research Funding. Kumar:Takeda: Research Funding; Celgene: Consultancy, Research Funding; Janssen: Consultancy, Research Funding.

Venetoclax-Based Regimen for Treatment of Patients with Acute Myeloid Leukemia in Community Based Practices

Introduction: There are limited options for acute myeloid leukemia (AML) patients who are too frail to receive intensive induction chemotherapy or who have relapsed /refractory disease. Early phase II trials published in 2016 demonstrated promising outcomes in AML with the BCL-2 inhibitor venetoclax, which was FDA approved in November 2018. We conducted a retrospective review of AML patients who received venetoclax at Kaiser Permanente Northern California (KPNC) specifically examining patients' characteristics and outcomes. Methods: This is a retrospective review of all KPNC patients who had a diagnosis of AML and received at least 1 prescription of venetoclax from January 1, 2016 through March 31, 2019. Data was abstracted from our electronic medical record. Variables included age, complete blood count, AML type, lines of therapy, prior use of hypomethylating agent, cytogenetics, somatic mutation, duration of treatment and chemotherapy regimen. Because none of the patients were treated under clinical trial protocol, most did not have a scheduled bone marrow biopsy to formally document disease status. Hematologic response (HR), defined here as neutrophil ≥ 0.5 x 109/L, platelet ≥ 50 x 109/L and RBC transfusion independence was used to access treatment effectiveness. Results were analyzed via descriptive statistics. Results: A total of 68 patients received venetoclax-based chemotherapy for treatment of AML. The median age was 68 (range 12-87). Among those 68 patients, 35% had venetoclax-based treatment as first line therapy, 35% as second line, and the remaining as third or later line (Table 1). Among those who received venetoclax as first line treatment, 58% had a HR. Among those who received venetoclax as second line treatment, 29% had a HR and 43% of those went on to allogeneic bone marrow transportation (BMT). 20% of those that received venetoclax in the third line setting had a HR and all went on to BMT. Patients who received venetoclax in fourth line or above did not have any significant response. Only 2 out of the 16 patients who received prior hypomethylating agent responded to venetoclax combination therapy. Four patients did not even complete cycle 1. 12 out of 68 patients were prescribed venetoclax based on FDA approved guidelines in November 2018. Of those 75% demonstrated HR. Conclusion While most of our patients used off-label venetoclax in a non-clinical trial setting, we confirm that venetoclax-based regimen is an effective treatment for AML, similar to published data. Our cohort represents a more heterogeneous population, which is more generalizable to the community. There is a higher response rate among those who used it in the first- and second-line setting (58% and 29% respectively). Venetoclax also showed efficacy in the second- or third-line setting, bridging patients to allogeneic BMT. Patients with prior hypomethylating agent are less likely to benefit from this drug. Venetoclax in combination with a hypomethylating agent is an effective AML regimen. Its efficacy deserves further studies, perhaps as a front-line treatment, sparing patients from intensive toxic inpatient induction chemotherapy. Disclosures No relevant conflicts of interest to declare. OffLabel Disclosure: This retrospective study evaluates the use of venenoclax-based regimen for treatment of AML. Clinicians have been using it since 2016, but the drug was not formally FDA approved for AML until November 2018.

2534. Development of an Infectious Diseases Fellowship Well-Being Program

BackgroundBurnout in graduate medical education is common and reported in ~70% of Internal Medicine (IM) residents. Most studies have described interventions focused on residency training, but fellowship training suffers from similar challenges and likely similar levels of burnout. After conducting a needs assessment amongst fellows within our Infectious Diseases (ID) fellowship program, we developed a wellness program to address these issues.MethodsIn Spring 2018, we reviewed the existing literature and consulted with local experts on trainee well-being. Based on our findings, we designed a multi-tiered approach to enhance wellness amongst fellows. An ID Fellowship Well-Being Committee (WBC) was created in September 2018 to lead the intervention. The WBC includes an even mix of fellows and faculty at multiple levels at all three main teaching hospitals associated with the program. Meetings occur every other month, and co-chairs (one faculty and one fellow) report back to the program director quarterly. Topic areas and interventions are described in Table 1. Fellows were sent a qualitative survey to evaluate the impact of the well-being interventions to date.ResultsFour of 5 first year fellows responded to the survey, and all felt the retreat should be repeated yearly. Themes identified from the survey included benefits of having protected time together, convening in a low pressure and informal setting to provide feedback, and spending quality time in a non-clinical setting with co-fellows. Fellows cited the wellness retreat as a strength at our annual fellowship external program review.ConclusionBurnout is likely high among IM sub-specialty fellows, and interventions are needed to support the well-being of those trainees. We describe a roadmap for the development of a well-being program at a relatively large, academic ID fellowship program led by a mixed fellow and faculty committee. We will continue to monitor data on fellow burnout and make programmatic changes based on feedback. We are hopeful that our work will empower other programs to engage in developing their own well-being programs. Disclosures All authors: No reported disclosures.

Real-world evidence evaluating continuation of CDK4/6 inhibitors beyond first progression in hormone receptor-positive (HR+) metastatic breast cancer.

e12538 Background: CDK inhibitors (CDKi), in combination with aromatase inhibitors (AI), are approved for the treatment of hormone receptor positive (HR+) Her2 negative metastatic breast cancer (MBC). The effectiveness of continuing CDKi beyond first disease progression is not known. This study evaluated real world evidence and assessed the impact of continuation of CDKi beyond first disease progression in combination with endocrine therapy. Methods: This is a retrospective, single institution review of HR+ MBC patients treated with CDKi from 2015-2018 who continued CDKi after initial progression. The primary outcome was progression-free survival (PFS) beyond first disease progression, as assessed by the clinician based on radiological and/or clinical criteria. Overall survival (OS) – defined as date of initial CDKi treatment to date of death or last follow up – was a secondary outcome. Results: 30 women with HR+/HER2- MBC, median age 47.5 years (range: 31 – 81), sequentially continued on CDKi beyond first progression were identified from a database of patients treated with Palbociclib. Median and average follow up times on CDKi were 27.18 and 24.53 months, respectively. Initial endocrine/CDKi regimen received included: palbociclib (PA)/letrozole (LTZ) [67%], PA/fulvestrant (FULV) [23%], and PA/other AI [10%]. Prescribed combinations beyond 1st progression were: PA/FULV [56.7%], PA/LTZ [16.7%], and PA/other AI [20%], abemaciclib plus LTZ or FULV [6%]. As of 1/31/2019, 25 patients (83.3%) were still alive, and 19 (63%) had undergone a second progression on CDKi. The estimated median PFS for the entire duration while on CDKi was 23.5 months (95% CI 12.8 – 27.8), of which 11.8 months (95% CI 5.34 – 13.13) was the median PFS beyond first progression. The estimated median OS was 45.4 months. Conclusions: Among a small cohort of HR+ MBC patients, in a non-clinical trial setting, continuation of palbociclib plus endocrine therapy beyond first progression was associated with a median PFS of approximately 11 months. Formal clinical evaluation of continuation of CDK inhibitor plus endocrine therapy beyond first progression is warranted.

Mouth Level Nicotine in a Clinical Setting versus Non-clinical Setting

Mouth Level Nicotine in a Clinical Setting versus Non-clinical Setting

A study of contact lens compliance in a non-clinical setting

PurposeTo evaluate soft contact lens replacement, overnight (ON) wear, and contact lens case compliance in a non-clinical sample. MethodsSubjects (n = 297) were recruited at the Center for Science and Industry (COSI) in Columbus, Ohio. Adult (≥ 18 years) soft contact lens wearers completed a survey about contact lens replacement, ON contact lens wear, and contact lens case replacement habits. ResultsTwo-week replacement lenses (according to the manufacturer’s replacement schedule [MRS]) were most common (45.5%), followed by monthly (34.3%) and daily replacement (20.2%). Non-compliance with replacement schedule was reported in 38.7% of subjects. Age (p = 0.02), years of lens wear (p = 0.02), and MRS (p <0.0001) affected replacement compliance. Post-hoc analysis showed daily replacement wearers were more compliant than two-week (p <0.0001) and monthly (p <0.0001) replacement wearers with prescribed lens replacement. Non-compliance with prescribed ON wear was reported in 23.9% of subjects. Subjects who were non-compliant with lens replacement were more likely to be non-compliant with ON wear (p = 0.02) and had worn contact lenses for less time (p = 0.02). Of the subjects who used contact lens cases, 74.6% were unsure when they should replace their case. Frequency of case replacement was not associated with age (p = 0.5), gender (p = 0.5), years of contact lens wear (p = 0.7), MRS (p = 0.4), replacement compliance (p = 0.3), or ON wear compliance (p = 0.7). ConclusionsDaily replacement wearers were most likely to be compliant with contact lens replacement, but all subjects, including daily replacement wearers, had similar ON wear non-compliance. Non-compliant lens replacement was associated with non-compliant ON wear, but contact lens case replacement was not related to either compliance category. The majority of subjects had no knowledge of proper contact lens case replacement, despite compliance in other categories.

An RCT of atraumatic restorative treatment for older adults: 5 year results

Objectivesto compare the survival of ART and a conventional restorative technique (CT) for restoring carious lesions in older adults after 5 years. MethodsIn this parallel randomised controlled clinical trial, 219 independently-living adults were recruited from a dental hospital/community and a geriatric day hospital. Ninety-nine patients who met the inclusion criteria and presented with carious lesions were randomly allocated to receive either ART or conventional restorations (anaesthesia, rotary instruments and resin-modified glass ionomer). The status of restorations was assessed 6 months, 1, 2 and 5 years after restoration placement. Estimates of cumulative survival were calculated for each interval between assessments and a Cox Proportional Hazards (PH) model was fitted to the interval-censored survival time. ResultsThree hundred restorations (ART n=142; CT n=158) were placed on 99 patients, 46 males and 53 females, with a mean age of 73.2, SD: 6.8 (65–90 yrs). After 5 years, ART and CT presented cumulative probability of survival of 85% and 79% (p=0.8095), respectively. Conclusions: ART presents survival rates comparable to a conventional technique, when treating older adults after 5 years. The ART approach could be a useful tool to provide dental care for older adults particularly in the nonclinical setting. (Trial Registration number: ISRCTN 76299321). Clinical RelevanceThis study shows that ART presents survival rates comparable to conventional techniques to treat carious lesions in older patients after 5 years. It is well accepted by this age cohort, and therefore could be an alternative to treat the elderly, especially those who are homebound or cannot attend the dentist.

Topical application of haemoglobin: a safety study.

Ischaemia is one of the biggest problems in wound healing. It causes chronic wounds and also prevents normal wound healing because the tissue is oxygen deprived. Most oxygen-supplying therapies are only feasible in a clinical setting, but topical haemoglobin applications, such as Granulox, can be used in a non-clinical setting. For home application, the haemoglobin solution is sprayed topically onto the wound using a pressurised ready-to-use device with a bag-on-valve system. Although this system does not mix product and propellant, the risk of product inhalation by the patient, user or bystanders has to be minimised. This safety study aimed to determine particle size and product concentration in the surroundings after application to determine if there is a risk that product particles enter the respiratory tract. Measurements were performed using a laser scattered light photometer and a Scanning Mobility Particle Sizer (SMPS)-Spectrometer at different distances from the measuring devices to determine the inhalation risk for a possible user, patient and bystander. At all measuring points the amount of particles, their size and the formation of dust were measured. No nanoparticles or dust were created during the application of the haemoglobin spray. The concentrations of the measured particles are below the allowed limits defined by Austrian law. There is no risk of inhaling nanoparticles or being exposed to harmful concentrations of larger particles of the tested product. All the product's ingredients can be degraded and excreted by the human body through natural pathways.

Opinie położnych na temat planowanego porodu odbywanego w warunkach pozaszpitalnych*

ABSTRACTIntroduction: According to the Nurses and Midwives Act and other legal Acts, a midwife is a person having appropriate competence for independent care of a woman during physiological pregnancy, childbirth and the postpartum period, and a newborn. These entitlements do not only apply to practice in a hospital or clinic, but also to home conditions, including physiological delivery in locations other than a hospital.The aim of the study is to know the opinion of midwives on planned births in non-hospital locations.Materials and methods: 233 midwives from all over Poland were surveyed. The survey was conducted between May and August 2014. The diagnostic survey method was applied using the author’s questionnaire. Statistica 10 and MS Office programs were used for statistical analysis.Results: 22.1% of the surveyed midwives expressed a willingness to attend a home birth. 67.1% of respondents would not attend a home birth. The decision to attend a birth in non-clinical setting was significantly dependent on the safety of such a birth (p = 0.0000).Conclusions: There was a statistically significant relationship between the opinion of the respondents on the safety of out-of-hospital birth setting and possible handling of such labors.

Assessment of Treatment Patterns and Adverse Events Among Patients with Chronic Myeloid Leukemia Using Tyrosine Kinase Inhibitors

INTRODUCTIONChronic myeloid leukemia (CML), a myeloproliferative neoplasm is primarily treated using tyrosine kinase inhibitors (TKIs). Several next-generation TKIs (dasatinib, nilotinib, bosutinib, ponatinib) have been approved since the first approval of imatinib in 2002. With varying safety profiles, data on non-trial long-term TKI use and associated adverse events (AE) can aid in clinical decision making. Using population based data sources the current study assessed treatment patterns and AEs in a non-trial setting among TKI users with CML. METHODSA retrospective cohort analysis was conducted using MarketScan Commercial, and Supplemental Medicare databases (2012-2016). Data includes details on medical (e.g., date of diagnosis, diagnosis codes, procedures) and pharmacy (e.g., drug dose, duration, strength) utilization for over 90 million individuals enrolled in employer-sponsored health-plans in the US. Patients with a prescription claim for TKI along with at least 2 medical claims on separate dates with a diagnosis code for CML (ICD-9-CM: 205.10 - 205.12; ICD-10: C92.10-C92.12) were selected. Patients were aged ≥18 years at TKI initiation and had continuous health plan enrollment ≥6 months before and ≥6 months after TKI initiation. Patients were followed from TKI initiation until health plan disenrollment or end of database, whichever occurred earlier (defines follow-up period). TKI treatment patterns including initial dose, initial and total TKI treatment duration, treatment switching and discontinuation were assessed. Frequency and proportion for incident (i.e. newly observed conditions) AEs including rash, bleeding, gastrointestinal disorders (nausea, vomiting, diarrhea), tumor lysis syndrome and cardiovascular events (CHF, arrhythmia, peripheral arterial occlusive disease, cerebrovascular events) and post-AE outcomes (switching, discontinuation, dose reduction) were assessed. AE list was developed based on commonly reported events in clinical trials involving TKIs for CML and clinical judgement. All analyses were descriptive in nature. RESULTSStudy included 2,213 CML patients with mean age (standard deviation [SD]) of 55 (15) years, of which 55% were male and 55% had ≥2 co-morbid conditions. Post CML diagnosis, first-line of TKI initiated was imatinib (41%), dasatinib (36%), nilotinib (22%), and bosutinib and ponatinib (1% each). The average (SD) follow-up duration post TKI initiation was 607 (442) days. Mean (SD) duration of first-line TKI prescription was 392 (383) days. 61% of patients continued initial TKI during the follow-up period, 7% discontinued and 32% switched/re-initiated TKI (Figure 1). 39.2% patients had at least 1 incident AE while on index TKI therapy. GI disorders (20.4%) were the most commonly observed AE, followed by cardiovascular events (14.6%), rash (8.4%), bleeding (8.0%), and TLS (0.2%). The average (SD) time to GI disorders, bleeding, cardiovascular event, rash, and TLS was 242 (274) days, 238 (272) days, 219 (261) days, 222 (255) days, and 223 (285) days, respectively. The rates of discontinuation, treatment switch or dose reduction were largely similar across all AEs (Figure 2).The mean duration on any TKI (all-lines of therapy) was 561 (438) days. The most commonly observed AEs on while of TKI therapy (irrespective of line of therapy) were GI disorders (24.7%), followed by cardiovascular events (17.3%), rash (11.5%), bleeding (10.1%) and TLS (0.5%). CONCLUSIONSThe study helps address the current literature gap of long-term treatment patterns and AE among patients with CML using TKIs in a non-clinical trial setting. During follow-up 46% patients experienced at least 1 incident AE while on TKI therapy. Majority of patients (61%) continued same TKI therapy following AE. The type and rate of AE were similar following first-line therapy and anytime on TKI (any-line) during the follow-up period. Study results may not be comparable to clinical trial findings due to certain limitations; e.g., this study did not capture all adverse events but assessed incident AE based on a pre-specified list. Also, due to limitations of administrative claims data, assessment of AE grade was not feasible. However, findings from this study can complement clinical trial data in selection of TKIs for long-term use in real-world setting and can also be of value in selecting TKIs for future clinical studies involving novel combinations in CML. [Display omitted] DisclosuresKarve:AbbVie: Employment, Equity Ownership. Huang:ZS Associates: Employment; Novo Nordisk Inc: Equity Ownership; AstraZeneca: Research Funding. Ranade:ZS Associates: Employment. Porwal:ZS Associates: Employment. Desai:AbbVie: Employment, Equity Ownership. Rosenberg:AbbVie: Employment, Equity Ownership.

Giving Thanks for Meaning in a Nonclinical Setting.

Updated several times a week with posts by a wide variety of authors, AJN's blog Off the Charts allows us to provide more timely-and often more personal-perspectives on professional, policy, and clinical issues. Best of the Blog will be a regular column to draw the attention of AJN readers to posts we think deserve a wider audience. To read more, please visit: www.ajnoffthecharts.com.

Can Nursing Students Gain Person-Centred Skills while Supporting Citizen Contacts to use the Internet for Health?

Introduction: Service users may benefit from digital health services by having access to reliable health information and ways to communicate health issues, thus fostering greater engagement in self-care. The University of Plymouth’s nursing students study ‘Digital Professionalism’ as part of an introduction to e-health in their curriculum. The University seeks to benefit local communities through direct community action. This study aims to explore the feasibility of implementing a model for students to enhance citizens’ knowledge and use of the Internet for health, and to provide an opportunity for students to understand citizens in their social context. Theory/Method: A collaborative action research approach has been used to develop and trial a citizen contact model. This study has two iterative cycles using mixed methods; a third will be undertaken. The first cycle explores the proposed activity with academics, health professionals, the public, and students. The second and third cycle’s trial the model, exploring its feasibility with stakeholders. Results: First cycle: Six workshops were undertaken. There was general consensus introducing a citizen contact model into the nursing curriculum was a good idea. An online survey further explored the thoughts of workshop participants and stakeholders. All 57 survey respondents agreed that the proposed activity would give students a better understanding of the thoughts and experiences of citizen contacts, and the majority 52/57 agreed citizen contacts would learn about health services. However, a number of concerns were raised including recruitment of citizen contacts, safeguarding of participants, and workloads. In October 2017, 473 first year students were invited to demonstrate one of five health websites to a friend, relative or neighbour as part of an assessment. The benefits were explored without confronting the problems of recruitment, safeguarding, and workloads. Second cycle: The recruitment of citizen contacts unknown to students and the organisation of visits has been addressed with volunteer second year adult nursing students. Three students and five citizen contacts participated in the implementation phase. Citizen contacts were recruited via a service user organisation. Reflective logs from students and questionnaires from citizen contacts are currently being collected. All participants are invited to explore their experiences in a follow-up. The model offers students the chance to visit a carer or someone living with a long-term health condition in pairs, to support them in using the Internet for health in a non-clinical setting. Discussion: Although a third cycle of collaborative action research will be undertaken offering child nursing students a similar opportunity, the model has not yet achieved unanimous support and routine implementation. However, stakeholders seem to accept the model. If we can implement the model for routine use, it could improve student and citizen learning. Collaborative action research, through a number of cycles, appears an appropriate methodology. Lessons Learned: Working with stakeholders is key to developing a feasible approach. Limitations: The model is being developed within one Higher Education Institute HEI, we cannot be sure the findings will transfer across to other HEIs. Suggestions for Future Research: Future research would trial this model at other HEIs.

Using Transactional Analysis to Help Foster Parents Develop Therapeutic Parenting Skills

This article considers the application of transactional analysis (TA) theory in a nonclinical setting with foster parents and discusses the merits of offering therapeutic training to this section of the United Kingdom children’s workforce. Transactional analysis theory is used to illustrate how TA knowledge can be crucial in helping foster parents to understand both their own internal world and that of the child. The author analyzes the gap in expectations regarding the training of foster parents generally and the enormity of the task they are asked to undertake. This is particularly onerous when looking after children who have been significantly harmed, with all the consequent emotional and behavioral difficulties that ensue.

THE PHYSIOLOGIC STRESS RESPONSE OF LEARNERS DURING CRITICAL CARE PROCEDURES: LIVE TISSUE VS SYNTHETIC MODELS

SESSION TITLE: Critical Care 1 SESSION TYPE: Original Investigation Posters PRESENTED ON: 10/10/2018 01:00 PM - 02:00 PM PURPOSE: The optimal level of physiologic stress during training is unclear, especially when learning procedures typically performed during a crisis. Extreme levels of stress can be deleterious to performance, but stress inoculation through activities that approximate the unease encountered in real-world scenarios has been shown to subsequently enhance performance. High-fidelity simulation offers many advantages, including broad exposure to procedures, their complications, and the opportunity for repetitious learning in a non-clinical setting. The stress of learners undergoing simulation events is a growing field of interest. Proponents of training with live-anesthetized animals argue the associated stress response cannot be equated with inanimate models, and therefore leads to an inferior learning experience with negative implications for future performance. METHODS: A randomized controlled study of 277 army combat medics was performed comparing procedural training and assessment on a live tissue (LT) goat model versus the best-in-class synthetic training models (STM). Participants were randomized twice, first to train on LT or STM, then to determine whether final assessment would be performed on LT or STM. Simulated procedures included hemorrhage control, needle thoracostomy, tube thoracostomy and cricothyrotomy. Physiologic stress responses of the medics were evaluated during the final assessment. Salivary amylase and cortisol levels were measured at baseline, t+5, 15, 25, 35, and 45 minutes post event start. RESULTS: No significant differences were seen for peak stress response of salivary cortisol or amylase, regardless of LT or STM method for training or assessment. In addition, the stress response did not correlate significantly with total performance score. CONCLUSIONS: Synthetic models can produce a stress response equivalent to that of live tissue during simulation training. This is the largest study to date indicating synthetic models produce a sufficient immersive and realistic experience for trainees. CLINICAL IMPLICATIONS: Stress inoculation while learning critical medical procedures can be achieved with synthetic models. Training programs may be able to reduce the use of live animals for training without sacrificing educational quality. DISCLOSURES: No relevant relationships by Tyler Bonnett, source=Web Response No relevant relationships by Danielle Hart, source=Web Response No relevant relationships by Jonathan Keller, source=Web Response No relevant relationships by Gregory Rule, source=Web Response Consultant relationship with Olympus Please note: $1-$1000 Added 03/02/2018 by Robert Sweet, source=Web Response, value=Consulting fee Owner/Founder relationship with Simagine Health Please note: $1-$1000 Added 03/02/2018 by Robert Sweet, source=Web Response, value=Ownership interest

Mindful Parenting Training in a Clinical Versus Non-Clinical Setting: An Explorative Study

Mindful parenting (MP) as a group-based training for parents of clinically referred children with psychopathology has shown to effectively reduce child and parent mental health problems. This study investigated the effects of MP as a “preventive” intervention for parents who experienced parental stress or problems in parenting (non-clinical setting) compared to MP as a “curative” intervention (clinical setting). Parents from a non-clinical setting (n = 98, 18% fathers) and a clinical setting (n = 87, 21% fathers) completed questionnaires about themselves, their partner relationship, and their child at waitlist (non-clinical setting only), pre-test, post-test, and 8-week follow-up. Before the intervention, the children of parents in the non-clinical setting, as expected, showed higher well-being and lower behavior problems, but parental stress levels, parental overreactivity, mindful parenting, partner relationship, and parental well-being were no different in the clinical and preventive group pre-intervention. No improvement was observed at waitlist, except for parental well-being, while improvement on parent and child functioning measures did occur after MP. No differences in MP effects in both settings were found in improved parental functioning (parental stress, overreactivity, mindful parenting, partner relationship, and well-being [small to medium effect size improvements]) and child functioning (well-being and behavior problems, small effect size improvements). Improvements in child functioning were associated with improved mindful parenting. Results suggest that MP training may be an effective intervention not only for families of children referred to mental health care because of child mental disorders but also for parents who experience parental stress or parenting problems as it is.

A Pilot Randomized Controlled Trial for a Videoconference-Delivered Mindfulness-Based Group Intervention in a Nonclinical Setting

Technology is increasingly being integrated into the provision of therapy and mental health interventions. While the evidence base for technology-led delivery of mindfulness-based interventions is growing, one approach to understand the effects of technology-delivered elements includes programs that retain some aspects of traditional face-to-face interaction. This arrangement offers unique practical advantages, and also enables researchers to isolate variables that may be underlying the effects of technology-delivered interventions. The present study reports on a pilot videoconference-delivered mindfulness-based group intervention offered to university students and staff members with wait-list controls. Apart from the first session of the 6-week course, the main facilitator guided evening classes remotely via online videoconferencing, with follow-up exercises via email. Participants were taught a variety of mindfulness-based exercises such as meditation, breathing exercises, and mindful tasting, as well as the concepts underpinning such practice. Participants completed pre- and post-intervention questionnaires on depression, anxiety, repetitive negative thinking, dysfunctional attitudes, positive and negative affect, self-compassion, compassion for others, and mindfulness. For participants who attended at least five of the six sessions, scores on all outcome measures improved significantly post-intervention and remained stable at 3-week follow-up. The videoconference-delivered mindfulness-based group intervention appears to provide a viable alternative format to standard mindfulness programs where the facilitator and participants need to live in close physical proximity with each other.

The experience of attunement and misattunement in dance movement therapy workshops

Moments of attunement and misattunement were explored in a dance movement therapy workshops. The guiding question was; “how do participants experience moments of attunement and misattunement in dance movement therapy workshops?” The study employed a quasi-experimental design, with phenomenological inquiry, including a two part analysis: Laban Movement Analysis and descriptive grounded theory using coding. Four students of expressive arts therapies attended four experimental dance movement therapy workshops, emphasising the process of mutual attunement. All workshops were video recorded. Based on video movement analysis, key moments of nonverbal attunement and misattunement were selected, and then analyzed within group interviews with participants. The results of the study show that successful attunement in dance movement therapy draws the client’s attention to the present moment; it encourages individual spontaneity, playfulness, and creativity; promotes embodiment, and thus the integration of mind and body. Successful attunement to the other leads to an intersubjective interchange, where two people co-create an intersubjective experience. Successful attunement to the group leads to the experience of oneness with the group. Moments of misattunement trigger unpleasant feelings, and result in a lack of spontaneity, feelings of exclusion, and hinder contact. The limitations of the results should be considered, as the study was done on a small number of participants and in nonclinical experimental setting. Researchers propose a larger study with clinical populations to further investigate the phenomenon of attunement and misattunement in dance movement therapy.