Clinical Leader Series: A Virtual Mental Well-being Initiative for Nurse Leaders During the COVID-19 Pandemic and Beyond.

OBJECTIVE: A virtual mental well-being initiative was developed for nurse leaders to provide education about mental health and to teach self-care skills. BACKGROUND: Because of substantial demand placed on nurse leaders during the COVID-19 pandemic, organizations must address stress and burnout by providing a continuum of care to include education, support, and intervention. METHODS: All levels of nurse leaders at a multicampus healthcare system were invited to attend. Data were collected on coping, empowerment, burnout, and quality of life. Participant responses to discussion prompts were compiled and reviewed. RESULTS: Although the independent parallel comparison did not show significant improvements, scores on the coping, empowerment, burnout, and quality-of-life measures were maintained. Discussion prompts yielded valuable insights into nurse leader experiences and session effectiveness. CONCLUSIONS: This type of education, as well as psychological support, will continue to be needed after the pandemic due to burnout, moral injury, and primary or secondary trauma. Findings are applicable to future crisis situations.

Building a framework for the evaluation of knowledge translation for the Canadian Network for Observational Drug Effect Studies.

PURPOSE: The Canadian Network for Observational Drug Effect Studies (CNODES), a network of pharmacoepidemiologists and other researchers from seven provincial sites, provides evidence on the benefits and risks of drugs used by Canadians. The Knowledge Translation Team, one of CNODES' four main teams, evaluates the impact of its efforts using an iterative and emergent approach. This article shares key lessons from early evaluation phases, including identifying stakeholders and their evaluation needs, choosing evaluation theories and approaches, and developing evaluation questions, designs, and methods appropriate for the CNODES context. METHODS: Stakeholder analysis was conducted using documentary analysis to determine key contextual factors and research evidence needs of decision maker partners and other stakeholders. Selected theories and frameworks from the evaluation and knowledge translation literature informed decisions about evaluation design and implementation. A developmental approach to evaluation was deemed appropriate due to the innovative, complex, and ever-changing context. RESULTS: A theory of change, logic model, and potential evaluation questions were developed, informed by the stakeholder analysis. Early indicators of program impact (citation metrics, alternative metrics) have been documented; efforts to collect data on additional indicators are ongoing. CONCLUSION: A flexible, iterative, and emergent evaluation approach allows the Knowledge Translation Team to apply lessons learned from completed projects to ongoing research projects, adapt its approaches based on stakeholder needs, document successes, and be accountable to funders/stakeholders. This evaluation approach may be useful for other international pharmacoepidemiology research networks planning and implementing evaluations of similarly complex, multistakeholder initiatives that are subject to constant change.

Implementation and outcomes of the New York State YMCA diabetes prevention program: a multisite community-based translation, 2010-2012.

INTRODUCTION: Weight loss and physical activity achieved through the Diabetes Prevention Program (DPP) have been shown to reduce type 2 diabetes risk among individuals with prediabetes. The New York State Young Men's Christian Association (YMCA) delivered the 16-week evidence-based model at 14 YMCAs. A mixed methods process and outcomes evaluation was conducted. METHODS: Most participants were referred by clinicians and were encouraged to achieve 5% to 7% weight loss. Participants were weighed weekly; additional data were gathered from participant surveys and focus groups and staff surveys and interviews. RESULTS: Participants (N = 254) lost a mean of 9 pounds (P < .001), or 4.2% of body weight, by program completion; 40% achieved 5% or more weight loss and 25% achieved 7% or more weight loss. Ten months after baseline, 61% of participants reported 5% or more weight loss and 48% reported 7% or more weight loss. In multivariate models, weight loss was negatively associated with black race (16 weeks: adjusted odds ratio [AOR], 0.190, P = .002; 10 months: AOR, 0.244, P = .005) and positively associated with attendance (16 weeks: AOR, 18.699, P < .001; 10 months: AOR, 2.808, P = .024). Participants reported improvements in health and lifestyle changes after program completion. Factors contributing to program success included coaches who motivated participants, the group setting, curriculum, and program duration. However, sociodemographic diversity was limited. CONCLUSION: Outcomes demonstrate the potential for effectively implementing the DPP in community-based settings. Findings also suggest the need for replications among a broader population.

Dual-energy X-ray absorptiometry prediction of adipose tissue depots in children and adolescents.

BACKGROUND: The measurement of adipose tissue (AT) depots in vivo requires expensive imaging methods not accessible to most clinicians and researchers. The study aim was to derive mathematical models to predict total AT (TAT) and subdepots from total body fat derived from a dual-energy X-ray absorptiometry (DXA) scan. METHODS: Models were developed to predict magnetic resonance imaging-derived TAT and subdepots subcutaneous AT, visceral AT, and intermuscular AT from DXA total body fat (Fat(DXA)) using cross-sectional data (time 0 (T0)) and validated results using 1 (T1) and 2 (T2) y follow-up data. Subjects were 176 multiethnic healthy children ages 5-17 y at T0. Twenty-two were measured at T1 and T2. TAT was compared with Fat(DXA). RESULTS: At T0, TAT was greater than Fat(DXA) (12.5 ± 8.4 vs.12.0 ± 9.4 kg; P < 0.0001), with a quadratic relationship between TAT and Fat(DXA) that varied by sex. Predicted mean TATs were not different from measured TATs: T1: (9.84 ± 4.45 kg vs. 9.50 ± 4.37 kg; P = 0.11); T2: (12.94 ± 6.75 kg vs. 12.89 ± 7.09 kg; P = 0.76). The quadratic relationship was not influenced by race or age. CONCLUSION: In general, the prediction equations for TAT and subdepots were consistent with the measured values using T1 and T2 data.

A Patient-Centered Conceptual Model of Symptoms and Their Impact in Early Parkinson's Disease: A Qualitative Study.

BACKGROUND: Individuals with Parkinson's disease (PD) develop a significant disease burden over time that contributes to a progressive decline in health-related quality of life. There is a paucity of qualitative research to understand symptoms and impacts in individuals with early-stage PD (i.e., Hoehn and Yahr stage 1-2 and ≤2 years since diagnosis). OBJECTIVE: The collection of qualitative data to inform the selection of clinical outcome assessments for clinical trials is advocated by regulators. This patient-centered, multistage study sought to create a conceptual model of symptoms and their impact for individuals with early-stage PD. METHODS: Symptoms and impacts of PD were gathered from a literature review of qualitative research, a quantitative social media listening analysis, and qualitative patient concept elicitation interviews (n = 35). Clinical experts provided input to validate and finalize the concepts. RESULTS: The final conceptual model consisted of 27 symptoms categorized into 'motor' or 'non-motor' domains, and 39 impacts divided into five domains. Most frequently reported symptoms in early-stage PD were 'tremors' (89%), 'stiffness and rigidity', and 'fatigue' (69%, both). Most frequently reported impacts included 'anxiety' (74%), 'eating and drinking' (71%), followed by 'exercise/sport' and 'relationship with family/family life' (66%, both). CONCLUSION: This study provides initial insights relating to the symptom and impact burden of early-stage PD patients. The conceptual model can be used to help researchers to develop and select optimal patient-centered outcomes to measure treatment benefit in clinical trials. These findings could inform future qualitative research and the development of outcomes specifically for early-stage PD patients.

Clinical Pharmacy Practice Patterns Among North Carolina Rural Hospitals.

INTRODUCTION: Rural hospitals are isolated without adequate funding needed to provide for clinical services offered at larger health systems. The purpose of this study is to determine the clinical pharmacy services available and desired by rural hospitals in North Carolina. METHODS: This prospective, cross-sectional, survey was distributed to a cohort of rural pharmacy directors and managers at rural hospitals across North Carolina. Data collected pertained to characteristics of the hospital and pharmacy, pharmacy director, clinical services, and responder impressions on their ability to maintain or enhance clinical services. Responses were summarized utilizing descriptive statistics and free-responses were coded for similar themes. RESULTS: Seventeen respondents (32.6%) completed the survey. Clinical activities varied, as did characteristics of the hospitals and staff. Improved patient care is the primary reason why hospital pharmacies expand their clinical participation (46.7%). Pharmacy directors believed growth of clinical activities was a long-term goal while reporting regulations, staff, and finances as barriers to growth. CONCLUSION: Clinical pharmacy services vary in NC rural hospitals. Directors exhibit a willingness to expand clinical responsibilities. Rural hospital pharmacy directors desire pharmacists to be active clinically in patient care, but face barriers in reaching that goal.

Leveraging Real-World Evidence: A Paradigm Shift in Regulation.

SUMMARY: The study methodology and regulatory frameworks for real-world data collection is quickly evolving, opening new avenues to use valid and robust real-world evidence (RWE) to support regulatory decision making. Although the Food and Drug Administration has historically accepted specific applications of RWE to support regulatory determinations, significant progress has been made in recent years to examine conditions in which this information can be used to support specific types of premarket decisions. Of note, hybrid study designs that incorporate aspects of randomized clinical trials, including randomization and pragmatic outcomes, are expected to be a driving factor to accelerate the adoption of RWE in regulatory contexts. Generation of RWE to better understand effectiveness and safety of orthopaedic- and trauma-related devices requires careful planning, but it is achievable as demonstrated by the Bioventus Observational Non-Interventional EXOGEN Studies (BONES) clinical development program. This article examines the role of RWE in regulatory decision making and reviews key concepts in RWE study design methodology to facilitate creation of valid scientific evidence in support of marketing authorizations.

Methodologies for Validation of Diagnoses in Real-World Data: BONES-A Case Study.

SUMMARY: The accuracy of any claim-based study is dependent on the quality of real-world coding of the condition of interest. This retrospective, administrative claims analysis presents a method for using a real-world data source to evaluate the accuracy of coding for nonunion of a fifth metatarsal fracture. Patients 21-80 years old with a diagnosis of a fifth metatarsal fracture between January 1, 2016, and October 31, 2016, and a nonunion of the fifth metatarsal fracture within the next 9 months were identified in the MarketScan Databases. Patient health care claims in the 12 months after the nonunion diagnosis were examined for health care encounters and pharmaceutical treatments considered indicative of treatment for nonunion, such as claims for bone growth stimulation or a second claim with a diagnosis of nonunion. Of the 230 patients who had at least one health care encounter attributable to a nonunion of the fifth metatarsal, 95.2% had at least one subsequent health care encounter confirming nonunion diagnosis. The mean number of supporting health care claims was 5.8, and the mean time between nonunion and first confirmatory claim was 33 days. This analysis demonstrated a method for evaluating the quality of coding for a specific condition when a traditional medical chart comparison is not feasible.

Breaking Barriers: Studying Fracture Healing in the BONES Program.

SUMMARY: The Bioventus Observational Noninterventional EXOGEN Studies (BONES) Program includes 3 concurrent studies designed to estimate the incidence of fracture nonunions in patients treated with the EXOGEN Ultrasound Bone Healing System compared with those receiving standard fracture care. This article outlines the design and methodology within the fifth metatarsal fracture study; similar approaches are taken in the second and third BONES Program studies, which examine nonunions of the tibia and scaphoid. The BONES Program is an external comparator design and incorporates several unique, fit-for-purpose components to strengthen the approach and allow it to be submitted to the US Food and Drug Administration (FDA) to be considered for a label expansion. BONES consisted of 2 cohorts: (1) EXOGEN-treated patients recruited into a patient registry and (2) comparator patients from a large administrative health claims database. The study used International Classification of Diseases, Tenth Revision, nonunion diagnosis codes reported by the treating clinician for the primary outcome measure. Many data sources (medical and billing records, patient-reported health data, usage data from the device itself, and commercial product complaint system) were used on the registry side, alongside insurance claims data to source the external comparator cohort, to achieve broader understanding of factors predisposing patients to the development of nonunions. In step with the FDA's increasing acceptance of real-world evidence for use in regulatory decision making and coupled with the infeasibility of a randomized clinical trial in this setting, the innovative study design of the BONES Program allowed for both an evaluation of the effect of EXOGEN in mitigating nonunions in a real-world setting and an assessment of the patient experience with EXOGEN treatment.

No sustained effects of an intervention to prevent excessive GWG on offspring fat and lean mass at 54 weeks: Yet a greater head circumference persists.

BACKGROUND: LIFT (Lifestyle Intervention for Two) trial found that intervening in women with overweight and obesity through promoting healthy diet and physical activity to control gestational weight gain (GWG) resulted in neonates with greater weight, lean mass and head circumference and similar fat mass at birth. Whether these neonate outcomes are sustained at 1-year was the focus of this investigation. METHODS: Measures included body composition by PEA POD air displacement plethysmography (ADP) and Echo Infant quantitative magnetic resonance (QMR) and head circumference at birth (n = 169), 14 (n = 136) and 54 weeks (n = 137). Differences in fat and lean mass between lifestyle intervention (LI) and Usual care (UC) groups were examined using ANCOVA adjusting for maternal age and BMI, GWG, offspring sex and age. RESULTS: Compared to UC, LI infants had similar weight (112 ± 131 g; P = .40), fat mass (14 ± 80 g; P = .86), lean mass (100 ± 63 g; P = .12) at 14 weeks and similar weight (168 ± 183 g; P = .36), fat mass (148 ± 124 g; P = .24), lean mass (117 ± 92 g; P = .21) at 54 weeks. Head circumference was greater in LI at 54 weeks (0.46 ± 2.1 cm P = .03). CONCLUSIONS: Greater lean mass observed at birth in LI offspring was not sustained at 14 and 54 weeks, whereas the greater head circumference in LI offspring persisted at 54 weeks.

Impact of Standardized Simulated Patients on First-Year Pharmacy Students' Knowledge Retention of Insulin Injection Technique and Counseling Skills.

Objective. To compare pre- and post-intervention test scores assessing insulin injection technique and counseling skills among P1 students with (intervention) or without (control) simulated patients, and to compare counseling checklist and knowledge retention test scores between groups. Methods. This study utilized cluster randomization. In addition to traditional instruction, the intervention group counseled a simulated patient on the use of insulin using the teach-back method. Test score changes from baseline were analyzed via two-sample t-test. Results. The intervention group exhibited a significantly greater increase in knowledge test scores from baseline compared to the control group. Similar changes were seen in post-instruction counseling checklist scores and knowledge retention test scores from baseline. Conclusion. Simulated patient interactions, when added to traditional coursework within a P1 skills lab, improve student counseling aptitude and knowledge retention scores.

Promoting higher blood pressure targets for frail older adults: a consensus guideline from Canada.

The authors, who are members of the Dalhousie Academic Detailing Service and the Palliative and Therapeutic Harmonization program, recommend that antihypertensive treatment be less intense in elderly patients who are frail. This paper reviews their recommendations and the evidence behind them.

Improving diabetes outcomes using a web-based registry and interactive education: a multisite collaborative approach.

INTRODUCTION: To support the adoption of guideline concordant care by primary care practices, the New York Diabetes Coalition (NYDC) promoted use of an electronic diabetes registry and developed an interactive educational module on using the registry and improving patient communication. The NYDC hypothesized that use of a registry with immediate feedback would achieve measurable and clinically meaningful improvement in the proportion of patients at goal for diabetes health metrics. RESEARCH DESIGN AND METHODS: In 2006-2007, the NYDC recruited 7 small to midsized primary care practices to implement the registry and to receive education and coaching on registry use, practice work flow, and patient engagement. The patient cohort included those with 2 or more visits with a diagnosis of diabetes within a 12-month period. Each patient's health measure status (at goal, above goal, not recorded) was assessed quarterly for hemoglobin A1C , low-density lipoprotein (LDL), and blood pressure (BP), and most recent A1C value was noted. A cohort analysis was performed using random effects regression models to assess the impact of the registry over time for each diabetes health metric. RESULTS: After controlling for variability between sites, with each subsequent quarter during the registry period patients were 1.4 times more likely to have A1C ≤ 9, almost twice (OR = 1.8) as likely to have LDL < 100, and 1.3 times more likely to have BP < 140/90. These improvements in compliance were statistically significant. Average A1C also improved over time, though this did not reach statistical significance. DISCUSSION: Utilizing a Web-based registry and interactive education, the project demonstrated improved patient outcomes, as well as the feasibility of collecting aggregate data from unrelated, independent practices.

Comparison of the immunogenicity and safety of measles vaccine administered alone or with live, attenuated Japanese encephalitis SA 14-14-2 vaccine in Philippine infants.

Japanese encephalitis (JE) virus is a major cause of disease, disability, and death in Asia. An effective, live, attenuated JE vaccine (LJEV) is available; however, its use in routine immunization schedules is hampered by lack of data on concomitant administration with measles vaccine (MV). This study evaluated the immunogenicity and reactogenicity of LJEV and MV when administered at the same or separate study visits in infants younger than 1 year of age. Three groups of healthy infants were randomized to receive LJEV at age of 8 months and MV at 9 months (Group 1; n=100); MV and LJEV together at 9 months (Group 2; n=236); or MV and LJEV at 9 and 10 months, respectively (Group 3; n=235). Blood was obtained 4 weeks after each vaccine administration to determine antibody levels for measles and JE. Reactogenicity was assessed by parental diaries and clinic visits. Four weeks after immunization, measles seroprotection rates (defined as > or =340 mIU/ml) were high and comparable in all three groups and specifically, rates in the combined MV-LJEV (Group 2) were not statistically inferior to those in Group 3 receiving MV separately (96% versus 100%, respectively). Likewise, the LJEV seroprotection rates were high and similar between the three groups. The reactogenicity profiles of the three vaccine schedules were also analogous. LJEV and MV administered together are well tolerated and immunogenic in infants younger than 1 year. These results should facilitate incorporation of LJEV into routine immunization schedules with MV.