Acromegaly Disease Control Maintained After Switching From Injected Somatostatin Receptor Ligands to Oral Paltusotine.

CONTEXT: Paltusotine is a nonpeptide selective somatostatin receptor 2 agonist in development as once-daily oral treatment for acromegaly. OBJECTIVE: To evaluate the efficacy and safety of paltusotine in the treatment of patients with acromegaly previously controlled with injected somatostatin receptor ligands (SRLs). METHODS: This phase 3, randomized, double-blind, placebo-controlled trial enrolled adults with acromegaly who had insulin-like growth factor I (IGF-I) ≤1.0 times the upper limit of normal (×ULN) while receiving a stable dose of depot octreotide or lanreotide. Patients were switched from injected SRLs and randomized to receive paltusotine or placebo orally for 36 weeks. The primary endpoint was proportion of patients maintaining IGF-I ≤1.0×ULN. Secondary endpoints were change in IGF-I level, change in Acromegaly Symptom Diary (ASD) score, and maintenance of mean 5-sample growth hormone (GH) <1.0 ng/mL. RESULTS: The primary endpoint was met: 83.3% (25/30) of patients receiving paltusotine and 3.6% (1/28) receiving placebo maintained IGF-I ≤1.0×ULN (odds ratio: 126.53; 95% CI: 13.73, >999.99; P<.0001). Paltusotine was also superior to placebo for all secondary endpoints: mean (±SE) change in IGF-I of 0.04±0.09×ULN versus 0.83±0.1×ULN (P<.0001); mean (±SE) change in ASD score of -0.6±1.5 versus 4.6±1.6 (P=.02); mean GH maintained at <1.0 ng/mL in 20/23 (87.0%) versus 5/18 (27.8%) patients (odds ratio: 16.61; 95% CI: 2.86, 181.36; P=.0003). The most common adverse events were acromegaly symptoms and gastrointestinal effects characteristic of SRLs. CONCLUSION: Replacement of injected SRLs by once-daily oral paltusotine was effective in maintaining both biochemical and symptom control in patients with acromegaly and was well tolerated.

Quality of life during usual epilepsy care for anxiety or depression symptoms: Secondary patient-reported outcomes in a randomized trial of remote assessment methods.

BACKGROUND AND OBJECTIVES: Anxiety and depression are highly prevalent and impactful in epilepsy. American Academy of Neurology quality measures emphasize anxiety and depression screening and quality of life (QOL) measurement, yet usual epilepsy care QOL and anxiety/depression outcomes are poorly characterized. The main objective was to assess 6-month QOL, anxiety and depression during routine care among adults with epilepsy and baseline anxiety or depression symptoms; these were prespecified secondary outcomes within a pragmatic randomized trial of remote assessment methods. METHODS: Adults with anxiety or depression symptoms and no suicidal ideation were recruited from a tertiary epilepsy clinic via an electronic health record (EHR)-embedded process. Participants were randomized 1:1 to 6 month outcome collection via patient portal EHR questionnaires vs. telephone interview. This report focuses on an a priori secondary outcomes of the overall trial, focused on patient-reported health outcomes in the full sample. Quality of life, (primary health outcome), anxiety, and depression measures were collected at 3 and 6 months (Quality of Life in Epilepsy-10, QOLIE-10, Generalized Anxiety Disorder-7, Neurological Disorders Depression Inventory-Epilepsy). Change values and 95 % confidence intervals were calculated. In post-hoc exploratory analyses, patient-reported anxiety/depression management plans at baseline clinic visit and healthcare utilization were compared with EHR-documentation, and agreement was calculated using the kappa statistic. RESULTS: Overall, 30 participants (15 per group) were recruited and analyzed, of mean age 42.5 years, with 60 % women. Mean 6-month change in QOLIE-10 overall was 2.0(95 % CI -6.8, 10.9), and there were no significant differences in outcomes between the EHR and telephone groups. Mean anxiety and depression scores were stable across follow-up (all 95 % CI included zero). Outcomes were similar regardless of whether an anxiety or depression action plan was documented. During the baseline interview, most participants with clinic visit EHR documentation indicating action to address anxiety and/or depression reported not being offered a treatment(7 of 12 with action plan, 58 %), and there was poor agreement between patient report and EHR documentation (kappa=0.22). Healthcare utilization was high: 40 % had at least one hospitalization or emergency/urgent care visit reported and/or identified via EHR, but a third (4/12) failed to self-report an EHR-identified hospitalization/urgent visit. DISCUSSION: Over 6 months of usual care among adults with epilepsy and anxiety or depression symptoms, there was no significant average improvement in quality of life or anxiety/depression, suggesting a need for interventions to enhance routine neurology care and achieve quality of life improvement for this group.

Pediatric nurses' fatigue descriptions in occupational injury reports: A descriptive qualitative study1.

Background: Despite the high risks associated with occupational fatigue in healthcare, few organizations require nurses to screen and report fatigue symptoms. As a result, little is known about if and how nurses would report fatigue while on the job. Objective: To determine if hospital-based pediatric nurses reported fatigue as part of an active injury reporting method. Methods: This secondary analysis of qualitative data used a descriptive design with content analysis. Data from the parent study were collected at a U.S. pediatric hospital where nurses verbally reported on-shift injuries or near misses and pre- and post-shift health status via a digital voice recorder. Researchers used content analysis to independently code data for nurses' references to fatigue. Codes were then analyzed for patterns and themes. Results: Approximately 30% (n = 104) of participants reported fatigue-related content. Emergent themes were Work Stressors, Individual Risk Factors, Fatigue Descriptors, Adverse Outcomes from Fatigue, Fatigue Buffers, Descriptors for Buffered Fatigue, and Favorable Outcomes from Buffered Fatigue. Fatigue descriptions align with prior literature, demonstrating the accuracy of the voice recorder data collection method. In addition, nurses expressed uncertainty about the appropriateness of reporting fatigue symptoms. Conclusion: Findings from this study support pediatric nurses will report fatigue, when provided an opportunity. Additional efforts are needed to better understand effective ways to improve fatigue reporting among nurses, including harnessing current technology for real-time reporting and how to change the culture around fatigue reporting.

"[It] Does Harden a Person Working in Such a Stressful Environment": U.S. Correctional Nurses Share Spillover Effects of Their Work.

BACKGROUND: The United States makes up 4.4% of the world's population but nearly a quarter of the world's incarcerated population. Despite caring for nearly 2 million incarcerated persons and managing their unique needs, little is known about how this work spills over and affects the nurses who work in correctional settings. STUDY OBJECTIVE: This descriptive study aimed to (a) examine write-in answers regarding correctional nurse perceptions of how their work impacts their health and their home lives and (b) explore correctional nurse responses for how to improve the work environment to better support their well-being. METHOD: The researchers compiled and analyzed qualitative data from a cross-sectional study where U.S. correctional nurses (N = 270) completed an online survey. Manifest content analysis was used to analyze optional write-in data. RESULTS: Approximately 41% (n = 111) of participants answered qualitative questions. Participants were primarily White (77.3%) and non-Hispanic or Latino (88.7%), working in prisons (65.8%), and employed by the state (63.8%) as registered nurses (70%). Three major themes emerged: (a) "personal impact": increased stress and burnout, overwhelming work hours, and emotional and physical effects; (b) "social relationships and family impacts": withdrawn, strained homelife, and uncertainty; and (c) "need for change": improved staffing, reduced mandatory overtime, and better support from management. CONCLUSIONS: Correctional organizations may consider ways to support the well-being of their nurses through adequate staffing, flexible scheduling, decreased mandatory overtime, and hiring effective nurse managers as key members of the correctional team.

Clinical Bootcamp: Moving toward competency outside of the clinic.

The COVID-19 Pandemic placed many challenges on the healthcare system. As healthcare providers were stretched thin and clinics were closed to any non-essential personnel, including learners, educational programs across the country scrambled to meet the needs of their students. In response to restrictions placed on traditional in-person clinical training, the University of Michigan Genetic Counseling Program (UMGCP) designed a Clinical Bootcamp (Bootcamp); a two-weeklong, blended educational activity using a framework of case-based learning (CBL) (McLean, 2016). Journal of Medical Education and Curricular Development, 3, JMECD.S20377). Herein is a description of the theory behind the design as well as specific details of the activities and evaluations to aid implementation and ideas for future applications. Activities developed for the Clinical Bootcamp retain relevance when clinical sites and experienced clinical supervisors are limited resources. We believe the Bootcamp can serve as a tool to expedite the transition of clinical skills to a new setting, allowing students to engage more fully upon entering a new clinical space, leading to optimal use of supervisors' time and experience, and allowing students to maximize the benefit of their time in clinic.

Unlocking Prevalence Data: Describing the Job Stress and Well-being of U.S. Correctional Nurses.

BACKGROUND: Little is known about the health and well-being of U.S. correctional nurses. To protect correctional nurses, a better understanding of organizational characteristics, job stress, and well-being must be undertaken. METHOD: A cross-sectional design was used in the form of an online survey. Correctional nurses were conveniently recruited using national listservs and snowball sampling. Variables were measured with the Health & Safety Executive Management Standards Indicator Tool, Nurse Wellbeing Index, and the Perceived Stress Scale. Data were analyzed using descriptive statistics and analyses of variance. FINDINGS: Two hundred seventy participants (142 registered nurses, 83 licensed practical nurses/licensed vocational nurses, and 42 advanced practice nurses) completed the survey. Job stress scored moderate (M = 16.26, SD = 7.14), and well-being levels were just below the risk for adverse events (M = 1.8, SD = 3.06). Lower scores were noted for managerial support (M = 3.13, SD = 0.35) and job demands (M = 3.56, SD = 0.92), but slightly better for job control (M = 3.57, SD = 0.77), peer support (M = 3.85, SD = 0.64), and workplace relationships (M = 3.73, SD = 0.95). CONCLUSIONS: Significant differences between organizational characteristics, job stress, and well-being were found across nursing licensure, workplace environments, biological sex, and employment through state or private agencies. Registered nurses working in U.S. prisons experienced the highest job stress and worse well-being. APPLICATION TO PRACTICE: This work is an essential next step in promoting healthy workspaces, urging the need for further research establishing the impact of organizational characteristics and job stress on nurse well-being.

Long-term efficacy and safety of subcutaneous pasireotide alone or in combination with cabergoline in Cushing's disease.

Objective: This study evaluated short- and long-term efficacy and safety of the second-generation somatostatin receptor ligand pasireotide alone or in combination with dopamine agonist cabergoline in patients with Cushing's disease (CD). Study design: This is an open-label, multicenter, non-comparative, Phase II study comprising 35-week core phase and an optional extension phase. All patients started with pasireotide, and cabergoline was added if cortisol remained elevated. Eligible patients had active CD, with or without prior surgery, were pasireotide naïve at screening or had discontinued pasireotide for reasons other than safety. Primary endpoint was proportion of patients with a mean urinary free cortisol (mUFC) level not exceeding the upper limit of normal (ULN) at week 35 with missing data imputed using last available post-baseline assessments. Results: Of 68 patients enrolled, 26 (38.2%) received pasireotide monotherapy and 42 (61.8%) received pasireotide plus cabergoline during the core phase. Thirty-four patients (50.0%; 95% CI 37.6-62.4) achieved the primary endpoint, of whom 17 (50.0%) received pasireotide monotherapy and 17 (50.0%) received combination therapy. Proportion of patients with mUFC control remained stable during the extension phase up to week 99. Treatment with either mono or combination therapy provided sustained improvements in clinical symptoms of hypercortisolism up to week 99. Hyperglycemia and nausea (51.5% each), diarrhea (44.1%) and cholelithiasis (33.8%) were the most frequent adverse events. Conclusion: Addition of cabergoline in patients with persistently elevated mUFC on maximum tolerated doses of pasireotide is an effective and well-tolerated long-term strategy for enhancing control of hypercortisolism in some CD patients. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT01915303, identifier NCT01915303.

Diagnosis and management of prolactin-secreting pituitary adenomas: a Pituitary Society international Consensus Statement.

This Consensus Statement from an international, multidisciplinary workshop sponsored by the Pituitary Society offers evidence-based graded consensus recommendations and key summary points for clinical practice on the diagnosis and management of prolactinomas. Epidemiology and pathogenesis, clinical presentation of disordered pituitary hormone secretion, assessment of hyperprolactinaemia and biochemical evaluation, optimal use of imaging strategies and disease-related complications are addressed. In-depth discussions present the latest evidence on treatment of prolactinoma, including efficacy, adverse effects and options for withdrawal of dopamine agonist therapy, as well as indications for surgery, preoperative medical therapy and radiation therapy. Management of prolactinoma in special situations is discussed, including cystic lesions, mixed growth hormone-secreting and prolactin-secreting adenomas and giant and aggressive prolactinomas. Furthermore, considerations for pregnancy and fertility are outlined, as well as management of prolactinomas in children and adolescents, patients with an underlying psychiatric disorder, postmenopausal women, transgender individuals and patients with chronic kidney disease. The workshop concluded that, although treatment resistance is rare, there is a need for additional therapeutic options to address clinical challenges in treating these patients and a need to facilitate international registries to enable risk stratification and optimization of therapeutic strategies.

Modeling wellbeing for U.S. correctional nurses: A cross sectional survey.

BACKGROUND: Nurses work in stressful environments, and this stress has negative consequences on health. Correctional nurses experience unique job stress in their roles. However, there has been limited research exploring how the correctional environment impacts nurse health and wellbeing. OBJECTIVE: This study aimed to evaluate the relationship between the variables of organizational characteristics (i.e., job demands, job control, manager support, peer support, workplace relationships), job stress, and wellbeing levels in a sample of U.S. correctional nurses, while exploring socio-demographic covariates. METHODS: Using a convenience sampling method, 270 U.S. correctional nurses completed a cross-sectional online survey. Informed by the Job Demands-Resources Theory, a conceptual model was created and tested in this sample. Analysis involved multiple linear regression and structural equation modeling. RESULTS: The model significantly fit the data (CI: 0.71-0.83, CFI = 0.51, SRMR: 0.37, and RMSEA = 0.08) revealing the direct relationship between job stress, job demands, job control, and workplace relationships and wellbeing. This study also provided evidence that job stress mediates the relationship of job control and job demands with wellbeing. CONCLUSION: Results underscore the opportunity for correctional organizations to consider targeting job demands, job control, workplace relationships, and job stress in future interventions to improve the correctional nursing work environment and support correctional nurse wellbeing. TWEETABLE ABSTRACT: A recent study found evidence for a relationship between organizational characteristics & job stress and U.S. correctional nurse wellbeing.

A Cross-Sectional Study of the Social Work Environment and Black Registered Nurses' Sleep.

INTRODUCTION: Workplace experiences may place Black nurses at higher risk for poor sleep and adverse health outcomes. This study aimed to identify poor sleep prevalence and associations of workplace discrimination and workplace social capital with sleep. METHODOLOGY: Descriptive statistics and multiple linear regression with exploratory analyses were conducted of cross sectional survey data from US Black nurses. RESULTS: On average, 63 respondents reported sleeping 6.15 h, 45 min less daily than 6.9 h reported nationally for nurses. Ninety-percent of respondents reported poor sleep quality. While no direct significance was found, respondents reporting sleep quality changes had lower workplace social capital and higher workplace discrimination. CONCLUSION: Black nurses may have higher prevalence of poor sleep than the larger nursing workforce. A potential relationship between decreased sleep quality and negative perceptions of the work environment may exist. Organizations should examine sleep and potential occupational health inequities among Black nurses when considering worker health.

Long-term Effectiveness and Safety of GH Replacement Therapy in Adults ≥60 Years: Data From NordiNet® IOS and ANSWER.

Context: Effectiveness and safety data on GH replacement therapy (GHRT) in older adults with adult GH deficiency (AGHD) are limited. Objective: To compare GHRT safety and clinical outcomes in older (≥60 years and, for some outcomes, ≥75 years) and middle-aged (35-<60 years) patients with AGHD. Design/setting: Ten-year follow-up, real-world data from 2 large noninterventional studies-NordiNet® International Outcome Study (IOS) and the American Norditropin® Studies: Web-Enabled Research (ANSWER) Program-were analyzed. Patients: GH-naïve and non-naïve patients with AGHD. Intervention: Norditropin® (somatropin). Main outcome measures: Outcomes included GH exposure, IGF-I standard deviation scores (SDS), body mass index (BMI), glycated hemoglobin (HbA1c), serious and nonserious adverse reactions (SARs and NSARs, respectively), and serious adverse events (SAEs). Adverse reactions were events with possible/probable causal relationship to GHRT. Results: The effectiveness analysis set comprised 545 middle-aged and 214 older patients (19 aged ≥75 years) from NordiNet® IOS. The full analysis set comprised 1696 middle-aged and 652 older patients (59 aged ≥75 years) from both studies. Mean GH doses were higher in middle-aged vs older patients. For both age groups and sexes, mean IGF-I SDS increased following GHRT, while BMI and HbA1c changes were similar and small.Incidence rate ratios (IRRs) did not differ statistically between older and middle-aged patients for NSARs [IRR (mean, 95% confidence interval) 1.05 (.60; 1.83)] or SARs [.40 (.12; 1.32)]. SAEs were more frequent in older than middle-aged patients [IRR 1.84 (1.29; 2.62)]. Conclusion: Clinical outcomes of GHRT in AGHD were similar in middle-aged and older patients, with no significantly increased risk of GHRT-related adverse reactions in older patients.

A scoping review of sleep education and training for nurses.

BACKGROUND: Shift work and resulting sleep impairment among nurses can increase their risk for poor health outcomes, occupational injuries, and errors due to sleep deficiencies. While sleep education and training for nurses has been recommended as part of a larger fatigue risk management system, little is known about training programs designed specifically for nurses. OBJECTIVE: Investigate the literature for current sleep education or training programs specifically for shift working nurses, with intent to assess training content, delivery characteristics, and outcome measures. DESIGN: A scoping review conducted October 2020 through September 2021. METHODS: The bibliographic databases Cumulative Index of Nursing and Allied Health (CINAHL), Scopus, PubMed, and NIOSHTIC-2 were searched using words such as "nurse," "sleep hygiene," "shift work," and "education". Studies were included if they: 1) were original research; 2) discussed sleep education, training, or sleep hygiene interventions; 3) included a study population of nurses engaging in shift work; 4) focused on sleep as a primary study measure; 5) were written in English language; and 6) were published in 2000 or later. RESULTS: Search results included 17,237 articles. After duplicates were removed, 14,620 articles were screened. Nine articles were found to meet established criteria. All studies included sleep hygiene content in the training programs, with five studies adding psychological and/or behavior change motivation training to support change in nurse sleep habits. Three studies added specific training for nurses and for managers. Delivery modes included in-person training of various lengths and frequency, mobile phone application with daily engagement, an online self-guided presentation, and daily reading material coupled with audio training. Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale were the outcome measures most frequently used. Although studies demonstrated improved sleep measures, most were pilot studies testing feasibility. CONCLUSION: Although there is a paucity of studies focused on sleep education and training for shift working nurses, we found the inclusion of sleep hygiene content was the only common characteristic of all nine studies. The variability in training content, delivery methods, and outcome measures suggests further research is needed on what constitutes effective sleep education and training for nurses.

Entrustment decision-making in genetic counseling supervision: Exploring supervisor and student perspectives to enhance training practices.

Entrustment decisions are an essential part of genetic counseling supervision and have the potential to influence a student's progression toward autonomy. However, there is often uncertainty among supervisors regarding how and when to make these decisions and very few studies have examined the impact of these decisions on students. This study utilized a mixed methods approach including surveys of genetic counseling supervisors (n = 76) and students (n = 86) as well as qualitative interviews with genetic counseling supervisors (n = 20) and students (n = 20) that explored factors that influence the entrustment decisions of genetic counseling supervisors and their effect on genetic counseling students. Genetic counseling supervisors and students were recruited from various organizations across the United States and Canada and represented a range of geographic regions, hospital systems, and genetic counseling programs. A hybrid process of deductive and inductive coding and thematic analysis was used to evaluate and interpret transcripts from the supervisor and student interviews. All participants identified advantages of increased autonomy during training. However, many supervisors reported low entrustment, seldom allowing students to complete unsupervised sessions or supervised cases without interruption. Entrustment decisions were heavily influenced by student ability and confidence, as well as patient feedback. Students emphasized the negative impact of decreased entrustment on their confidence and described clear benefits to increased autonomy before, during, and after the genetic counseling appointment. Supervisors identified various barriers to entrustment pertaining to the student, clinical setting, and the patient, whereas students more often emphasized barriers pertaining to themselves. Our results highlight a tension between the clear advantages of increased entrustment and autonomy and various barriers to the provision of these opportunities. Additionally, our data suggest several ways to enhance the supervisor-student relationship and promote additional learning opportunities to support student-centered supervision.

Corrigendum: Guidance for the treatment of adult growth hormone deficiency with somapacitan, a long-acting growth hormone preparation.

[This corrects the article DOI: 10.3389/fendo.2022.1040046.].

Rapid-onset dystonia-parkinsonism is associated with reduced cerebral blood flow without gray matter changes.

Purpose: Previous research showed discrete neuropathological changes associated with rapid-onset dystonia-parkinsonism (RDP) in brains from patients with an ATP1A3 variant, specifically in areas that mediate motor function. The purpose of this study was to determine if magnetic resonance imaging methodologies could identify differences between RDP patients and variant-negative controls in areas of the brain that mediate motor function in order to provide biomarkers for future treatment or prevention trials. Methods: Magnetic resonance imaging voxel-based morphometry and arterial spin labeling were used to measure gray matter volume and cerebral blood flow, respectively, in cortical motor areas, basal ganglia, thalamus, and cerebellum, in RDP patients with ATP1A3 variants (n = 19; mean age = 37 ± 14 years; 47% female) and variant-negative healthy controls (n = 11; mean age = 34 ± 19 years; 36% female). Results: We report age and sex-adjusted between group differences, with decreased cerebral blood flow among patients with ATP1A3 variants compared to variant-negative controls in the thalamus (p = 0.005, Bonferroni alpha level < 0.007 adjusted for regions). There were no statistically significant between-group differences for measures of gray matter volume. Conclusions: There is reduced cerebral blood flow within brain regions in patients with ATP1A3 variants within the thalamus. Additionally, the lack of corresponding gray matter volume differences may suggest an underlying functional etiology rather than structural abnormality.

Tiredness Takes Its Toll: An Integrative Review on Sleep and Occupational Outcomes for Long-Term Care Workers.

Poor sleep quality and duration among health care professionals have negative impacts on worker safety, work readiness, and well-being. However, the consequences of impaired sleep among long-term care (LTC) workers remain understudied. The current integrative review sought to explore associations between sleep and occupational outcomes in LTC workers. Multiple database searches yielded 1,543 articles; nine articles met inclusion criteria. Results synthesized from included articles revealed sleep-associated occupational outcomes across three themes, Burnout/Fatigue, Mental and Physical Health, and Well-Being, which may affect performance measures and predict injuries/errors. Exploring outcomes of poor sleep quality and duration among LTC workers has highlighted the needs of this population and may inform future intervention development. LTC organizations should consider implementing strategies to better support the sleep quality of their workforce. In addition, further research is needed to explore how impaired sleep contributes to negative worker outcomes and patient care quality. [Journal of Gerontological Nursing, 49(1), 27-33.].