Mortality with concurrent treatment with gabapentin and opioids among people with spine diagnoses in the U.S. Medicare population: a propensity-matched cohort study.

IMPORTANCE: Given the negative impact of opioid use on population health, prescriptions for alternative pain-relieving medications, including gabapentin, have increased. Concurrent gabapentin and opioid prescriptions are commonly reported in retrospective studies of opioid-related overdose deaths. OBJECTIVE: To determine whether people who filled gabapentin and opioid prescriptions concurrently ('gabapentin + opioids') had greater mortality than those who filled an active control medication (tricyclic antidepressants [TCAs] or duloxetine) and opioids concurrently ('TCAs/duloxetine + opioids'). We hypothesized that people treated with gabapentin + opioids would have higher mortality rates compared to people treated with TCAs/duloxetine + opioids. DESIGN: Propensity score-matched cohort study with an incident user, active control design. The median (maximum) follow-up was 45 (1093) days. SETTING: Population-based. PARTICIPANTS: Medicare beneficiaries with spine-related diagnoses 2017-2019. The primary analysis included those who concurrently (within 30 days) filled at least 1 incident gabapentin + at least 1 opioid or at least 1 incident TCA/duloxetine + at least 1 opioid. EXPOSURES: People treated with gabapentin + opioids (n=67,133) were matched on demographic and clinical factors in a 1:1 ratio to people treated with TCAs/duloxetine + opioids (n=67,133). MAIN OUTCOMES AND MEASURES: The primary outcome was mortality at any time. A secondary outcome was occurrence of a major medical complication at any time. RESULTS: Among 134,266 participants (median age 73.4 years; 66.7% female), 2360 died before the end of follow-up. No difference in mortality was observed between groups (adjusted hazard ratio (HR) and 95% confidence interval (CI) for gabapentin + opioids was 0.98 (0.90, 1.06); p=0.63). However, people treated with gabapentin + opioids were at slightly increased risk of a major medical complication (1.02 (1.00, 1.04); p=0.03) compared to those treated with TCAs/duloxetine + opioids. Results were similar in analyses (a) restricted to less than or = 30-day follow-up and (b) that required at least 2 fills of each prescription. CONCLUSIONS AND RELEVANCE: When treating pain in older adults taking opioids, the addition of gabapentin did not increase mortality risk relative to addition of TCAs or duloxetine. However, providers should be cognizant of a small increased risk of major medical complications among opioid users initiating gabapentin compared to those initiating TCAs or duloxetine.

Australian nursing students' experiences of workplace violence during clinical placement: A cross-sectional study.

AIM: To identify the nature, degree and contributing factors of workplace violence (WPV) incidents experienced by Australian nursing students during clinical placement. DESIGN: Descriptive cross-sectional study. METHODS: Data were collected from 13 September to 25 November 2022. Eligible participants included all nursing students enrolled in nursing degrees at any Australian university who had completed at least one clinical placement. An adapted version of the WPV in the Health Sector Country Case Study survey was used. RESULTS: A total of 381 nursing students across eight states of Australia completed the survey. More than half of the students had experienced an episode of WPV; patients were the most frequent perpetrators. Personal factors of patients, staff and students, organizational factors and cultural norms within the workplace supported acts of WPV. CONCLUSION: Student nurses (SNs) most often experience violence from patients during direct care. Patient encounters are the core component of clinical placement. Education providers have a responsibility to effectively prepare students to be able to identify escalating situations and manage potentially violent situations. Registered nurses who supervise students during clinical placement require support to balance their clinical role with student supervision. IMPLICATIONS FOR THE PROFESSION: Experiencing WPV can negatively impact relationships between students, healthcare professionals and care recipients. This results in personal distress, decreased job satisfaction and potentially the decision to leave the nursing profession. IMPACT: What already is known: SNs are exposed to WPV during clinical placement. WHAT THIS PAPER ADDS: More than half the SNs in this study experienced violence inclusive of physical, verbal, racial and sexual harassment. Patients were the predominant perpetrators. Implications for practice/policy: Interventions at individual and systemic levels are required to mitigate WPV. REPORTING METHOD: This study is reported using the STROBE guidelines.

Nursing students satisfaction and self-confidence with standardized patient palliative care simulation focusing on difficult conversations.

OBJECTIVES: Lack of experience communicating with patients and families at the end of life are key concerns for nursing students. Palliative care simulation using standardized patients (SPs) focusing on difficult conversations may lead to increased self-confidence in providing palliative and end-of-life care in clinical practice. There is currently a paucity of research on SP palliative care simulations in undergraduate nursing education. The objective of this research was to assess 3rd year undergraduate nursing students' levels of satisfaction and self-confidence with palliative and end-of-life care simulations focusing on difficult conversations, as measured by the Student Satisfaction and Self-Confidence in Learning Scale (SSSCLS) and the Simulation Design Scale (SDS). METHODS: A descriptive post-intervention study. Four palliative care simulation days, consisting of 2 clinical scenarios, were conducted over 4 weeks. The first simulation was an outpatient palliative care clinic scenario, and the second was an inpatient hospital scenario. Nursing students enrolled in a 3rd year nursing palliative care elective (n = 51) at an Australian university were invited to participate. Students who attended simulation days were eligible to participate (n = 31). Immediately post-simulation, students were invited to complete the SSSCLS and the SDS. Fifty-seven surveys were completed (simulation 1, n = 28; simulation 2, n = 29). The data were analyzed using descriptive statistics. RESULTS: Results showed that students had high levels of self-confidence in developing palliative care and communication skills after both simulation experiences and high levels of satisfaction with the SP simulations. SIGNIFICANCE OF RESULTS: The lack of published literature on palliative care and end-of-life SP simulation highlights the need to collect further evidence to support this as an innovative approach to teaching palliative care. SP palliative care simulation focusing on difficult conversations assists in developing students' communication skills and improves satisfaction and self-confidence with palliative and end-of-life care.

Interventions to prevent or manage workplace violence against student nurses during clinical placement: a systematic review protocol.

OBJECTIVES: The objective of this review is to investigate the effectiveness of workplace violence management or prevention interventions, including strategies, protocols, and policies, to address violence against, and provide support to, registered nursing students (RNS) following incidents of violence during clinical placement. INTRODUCTION: Workplace violence is a global issue that affects victims' physical and mental health. RNS are especially vulnerable to workplace violence because of their limited work experience and confidence. These students often feel shocked and unprepared when experiencing workplace violence due to limited education and support provided by educational institutions or clinical sites. Workplace violence can lead to anxiety, decreased confidence, and professional attrition. There is a need to systematically synthesize the evidence on workplace violence management and prevention to support nursing students during clinical placement. INCLUSION CRITERIA: The review will consider studies assessing the effectiveness of interventions to address workplace violence or improve support for RNS. Studies that report on educational interventions or pre-clinical placement strategies and measure the preparedness of students will also be considered. Study designs will be limited to quantitative methods that evaluate intervention effectiveness. METHODS: Databases to be searched include MEDLINE (Ovid), CINAHL (EBSCOhost), Web of Science Core Collection, Scopus, Embase (Ovid), Cochrane Central, ERIC (ProQuest), ProQuest Central, ProQuest Social Science Premium Collection, and ProQuest Dissertations and Theses Global. Two independent reviewers will screen, review, appraise, and extract data from eligible articles. For data synthesis, studies will be pooled using JBI SUMARI. The GRADE approach for grading the certainty of evidence will be followed and a Summary of Findings will be created. REVIEW REGISTRATION: PROSPERO CRD42022377318.

Implementing a medication lubricant for pill dysphagia on an acute care ward using Plan-Do-Study-Act cycles.

BACKGROUND: Pill dysphagia, the difficulty in swallowing solid oral medications, is a common problem that can affect medication adherence and increase pill modifications. Current practices of crushing medications or using food vehicles have limitations and potential risks. This report describes the implementation of a medication lubricant, Gloup, for pill dysphagia on an acute care ward using Plan-Do-Study-Act cycles. OBJECTIVE: The objective of this project was to evaluate the implementation of Gloup in the acute care ward setting and assess its acceptability and uptake by patients and ward nurses during medication administration. METHODS: The project involved chart audits of medication administration records, collection of patient feedback, and staff feedback through meetings. Patient characteristics and medication administration practices were documented. The implementation process included education and training sessions for staff, development of a medication chart sticker for evaluation data collection and small-scale testing of Gloup with patients before ward-level implementation. RESULTS: The implementation of Gloup on the acute care ward showed high uptake and acceptability. The majority of patients using Gloup had crushed medications, and the use of Gloup varied based on patient needs. CONCLUSION: The implementation of Gloup as a medication lubricant for pill dysphagia on an acute care ward was successful and well received by patients and staff. The use of Gloup appeared to improve medication administration practices and reduce the need for crushing medications or using food vehicles. This project highlights the importance of addressing pill dysphagia in acute care settings and provides insights for other wards considering similar interventions.

Generalizability of Deep Learning Classification of Spinal Osteoporotic Compression Fractures on Radiographs Using an Adaptation of the Modified-2 Algorithm-Based Qualitative Criteria.

RATIONALE AND OBJECTIVES: Spinal osteoporotic compression fractures (OCFs) can be an early biomarker for osteoporosis but are often subtle, incidental, and underreported. To ensure early diagnosis and treatment of osteoporosis, we aimed to build a deep learning vertebral body classifier for OCFs as a critical component of our future automated opportunistic screening tool. MATERIALS AND METHODS: We retrospectively assembled a local dataset, including 1790 subjects and 15,050 vertebral bodies (thoracic and lumbar). Each vertebral body was annotated using an adaption of the modified-2 algorithm-based qualitative criteria. The Osteoporotic Fractures in Men (MrOS) Study dataset provided thoracic and lumbar spine radiographs of 5994 men from six clinical centers. Using both datasets, five deep learning algorithms were trained to classify each individual vertebral body of the spine radiographs. Classification performance was compared for these models using multiple metrics, including the area under the receiver operating characteristic curve (AUC-ROC), sensitivity, specificity, and positive predictive value (PPV). RESULTS: Our best model, built with ensemble averaging, achieved an AUC-ROC of 0.948 and 0.936 on the local dataset's test set and the MrOS dataset's test set, respectively. After setting the cutoff threshold to prioritize PPV, this model achieved a sensitivity of 54.5% and 47.8%, a specificity of 99.7% and 99.6%, and a PPV of 89.8% and 94.8%. CONCLUSION: Our model achieved an AUC-ROC>0.90 on both datasets. This testing shows some generalizability to real-world clinical datasets and a suitable performance for a future opportunistic osteoporosis screening tool.

Elements of long-term care that promote quality of life for Indigenous and First Nations Peoples: A mixed methods systematic review.

BACKGROUND AND OBJECTIVES: Little is known about elements of long-term care (LTC) that promote quality of life (QoL) for older Indigenous and First Nations peoples. This systematic review aimed to extend understanding of those deemed most important. RESEARCH DESIGN AND METHODS: Following PRISMA guidelines, systematic database and hand-searching were used to find published and unpublished qualitative studies and textual reports. A convergent integrated approach was used to synthesize data, according to the Joanna Briggs Institute methodology for mixed methods systematic reviews. RESULTS: Included papers (11 qualitative; 7 reports) explored views and experiences of Indigenous residents, families, and LTC staff from North America (8), South Africa (1), Norway (1), New Zealand (1), and Australia (7). Elements of care included: i) co-designing and collaborating with Indigenous and First Nations communities and organizations to promote culturally safe care; ii) embedding trauma-informed care policies and practices, and staff training to deliver culturally safe services; iii) being respectful of individual needs, and upholding cultural, spiritual and religious beliefs, traditional activities and practices; iv) promoting connection to culture and sense of belonging through sustained connection with family, kin and Indigenous and First Nations communities. DISCUSSION AND IMPLICATIONS: This review identifies elements or models of care that promote QoL for Indigenous and First Nations peoples in LTC. While included papers were mostly from the United States and Australia, the congruence of elements promoting QoL was evident across all population groups. Findings may be used to inform standards specific to the care of Indigenous and First Nations peoples.

Promoting Person-Centered Care for Health Baccalaureate Students: Piloting an Interprofessional Education Approach to Wound Management.

OBJECTIVE: To describe and analyze the implementation of a wound management interprofessional education experience for nursing, podiatry, pharmacy, and exercise and nutrition science health baccalaureate students. The disciplines outside of nursing were invited to join the classes of a wound care elective unit in nursing. METHODS: This study included the development and implementation of a wound care program and observation of all students enrolled in the health disciplines where wound management education was relevant. RESULTS: Results indicated an increase in students' recognition of their roles and the roles of others within an interprofessional healthcare team. Facilitators reported that students learned to share information and work collaboratively to plan care for people with wounds. CONCLUSIONS: The outcomes confirm that the structured wound management program of interprofessional education within a Faculty of Health course promoted student recognition of wound management and the essential shared approach to person-centered care.

Risk factors for the recurrence of venous leg ulcers in adults: A systematic review protocol.

BACKGROUND: Venous leg ulcers are slow to heal, and recurrence is frequent. Living with venous leg ulcers can affect physical and psychological health, and result in financial burden for individuals. Physiological and psychosocial factors are associated with venous leg ulcer recurrence. As over 50% of venous leg ulcers will recur within 12 months of healing, a comprehensive knowledge of holistic risk factors associated with recurrence is required by health professionals involved in the care of the person with venous leg ulcers. AIM: To develop a systematic review protocol to determine the risk factors for recurrence of venous leg ulcers in adults. METHOD AND ANALYSIS: This protocol was developed according to the Preferred Reporting Items Form Systematic Review and Meta-Analysis Protocols (PRISMA-P). The inclusion criteria will be based on the PICOS mnemonic-adults with a history of venous leg ulcer/s (participants), risk factor/s under physiological (general/medical), clinical, demographics, psychosocial categories (I (intervention) or E (exposure), venous leg ulcer non-recurrence (comparison group), venous leg ulcer recurrence (outcomes to be measured) and will include study designs of original qualitative, quantitative and mixed method studies (study designs to be included). Methodological quality will be assessed using the Mixed Methods Appraisal Tool. This Systematic Review Protocol was registered in PROSPERO [CRD42021279792]. RESULTS: If meta-analysis is not possible, a narrative review of results will be presented. CONCLUSIONS: This systematic review on recurrence of venous leg ulcers can provide evidence-based information for preventive strategies for recurrence of a healed venous leg ulcer. The standardised approach outlined in this systematic review protocol offers a rigorous and transparent method to conduct the review.

The Lumbar Stenosis Prognostic Subgroups for Personalizing Care and Treatment (PROSPECTS) study: protocol for an inception cohort study.

BACKGROUND: Lumbar spinal stenosis (LSS) is a common degenerative condition that contributes to back and back-related leg pain in older adults. Most patients with symptomatic LSS initially receive non-operative care before surgical consultation. However, there is a scarcity of data regarding prognosis for patients seeking non-surgical care. The overall goal of this project is to develop and evaluate a clinically useful model to predict long-term physical function of patients initiating non-surgical care for symptomatic LSS. METHODS: This is a protocol for an inception cohort study of adults 50 years and older who are initiating non-surgical care for symptomatic LSS in a secondary care setting. We plan to recruit up to 625 patients at two study sites. We exclude patients with prior lumbar spine surgeries or those who are planning on lumbar spine surgery. We also exclude patients with serious medical conditions that have back pain as a symptom or limit walking. We are using weekly, automated data pulls from the electronic health records to identify potential participants. We then contact patients by email and telephone within 21 days of a new visit to determine eligibility, obtain consent, and enroll participants. We collect data using telephone interviews, web-based surveys, and queries of electronic health records. Participants are followed for 12 months, with surveys completed at baseline, 3, 6, and 12 months. The primary outcome measure is the 8-item PROMIS Physical Function (PF) Short Form. We will identify distinct phenotypes using PROMIS PF scores at baseline and 3, 6, and 12 months using group-based trajectory modeling. We will develop and evaluate the performance of a multivariable prognostic model to predict 12-month physical function using the least absolute shrinkage and selection operator and will compare performance to other machine learning methods. Internal validation will be conducted using k-folds cross-validation. DISCUSSION: This study will be one of the largest cohorts of individuals with symptomatic LSS initiating new episodes of non-surgical care. The successful completion of this project will produce a cross-validated prognostic model for LSS that can be used to tailor treatment approaches for patient care and clinical trials.

Factors influencing nursing students' ability to recognise and respond to simulated patient deterioration: A scoping review.

AIM: The aim of this scoping review was to identify empirical literature on simulation used to develop undergraduate nursing student's clinical assessment skills to recognise and respond to patient deterioration. BACKGROUND: Early recognition and response to clinical deterioration is necessary to ensure the best outcome for the patient. Undergraduate nursing students have limited exposure to deteriorating patient situations, therefore simulation is widely implemented in nursing courses to address this educational need. It is imperative to identify the simulation modalities and features that best optimise student learning. DESIGN: Scoping review using the Joanna Briggs Institute scoping reviews methodology and the Arksey and O'Malley framework. REVIEW METHODS: Seven health databases were searched electronically for relevant literature and complemented with hand searching for additional relevant sources. A total of 344 potential articles were identified from the seven databases: Cumulative Index to Nursing and Allied Health Literature (n = 234); PubMed (n = 16); Medline (n = 51); Scopus (n = 21); Embase (n = 3); American Psychological Association PsychInfo (n = 13); and JBI (n = 6). After applying inclusion and exclusion criteria, 15 research articles were included in the review. RESULTS: Most research on clinical deterioration simulation was quantitative (n = 12), two were qualitative and one used a mixed method approach. Findings included a lack of situational awareness, distractors causing incomplete patient assessment and failure to recognise deterioration. Repeated simulation showed positive results. CONCLUSIONS: Findings of this review suggest students lack situational awareness, perform incomplete assessment and fixate on single cues rather than an entire clinical picture. The use of a variety of simulation modalities was effective in improving student performance. Repeated practice within a single simulated learning experience, was shown to improve performance and situational awareness. This approach to simulation is under-researched in nursing and needs further exploration.

Deep Learning Classification of Spinal Osteoporotic Compression Fractures on Radiographs using an Adaptation of the Genant Semiquantitative Criteria.

RATIONALE AND OBJECTIVES: Osteoporosis affects 9% of individuals over 50 in the United States and 200 million women globally. Spinal osteoporotic compression fractures (OCFs), an osteoporosis biomarker, are often incidental and under-reported. Accurate automated opportunistic OCF screening can increase the diagnosis rate and ensure adequate treatment. We aimed to develop a deep learning classifier for OCFs, a critical component of our future automated opportunistic screening tool. MATERIALS AND METHODS: The dataset from the Osteoporotic Fractures in Men Study comprised 4461 subjects and 15,524 spine radiographs. This dataset was split by subject: 76.5% training, 8.5% validation, and 15% testing. From the radiographs, 100,409 vertebral bodies were extracted, each assigned one of two labels adapted from the Genant semiquantitative system: moderate to severe fracture vs. normal/trace/mild fracture. GoogLeNet, a deep learning model, was trained to classify the vertebral bodies. The classification threshold on the predicted probability of OCF outputted by GoogLeNet was set to prioritize the positive predictive value (PPV) while balancing it with the sensitivity. Vertebral bodies with the top 0.75% predicted probabilities were classified as moderate to severe fracture. RESULTS: Our model yielded a sensitivity of 59.8%, a PPV of 91.2%, and an F1 score of 0.72. The areas under the receiver operating characteristic curve (AUC-ROC) and the precision-recall curve were 0.99 and 0.82, respectively. CONCLUSION: Our model classified vertebral bodies with an AUC-ROC of 0.99, providing a critical component for our future automated opportunistic screening tool. This could lead to earlier detection and treatment of OCFs.

Exploring the observer role and clinical reasoning in simulation: A scoping review.

AIM: This scoping review aimed to explore nursing students experience as simulation observers and their level of engagement in learning through use of clinical decision-making models and learning scaffolds. BACKGROUND: A gap continues to exist between the published empirical literature, the role and experiences of the simulation observer and teaching scaffolds that enhance learning outcomes, despite the increased understanding of simulation and its role in preparing nursing students for practice. Further, little is known about the nursing student's experience of clinical reasoning whilst observing simulation and the impact of scaffolding observations using clinical decision-making models. DESIGN: This scoping review was conducted using the methodological framework of Arksey and O'Malley (2005) and the PRISMA checklist for systematic reviews (Page et al., 2020). METHODS: A comprehensive search of the literature published in Medline and CINAHL databases between 1999 and 2020 was undertaken in May 2019. The studies selected for this review (n = 18) were analyzed thematically. The validated Mixed-Methods Appraisal Tool assessed quality of the quantitative, qualitative and mixed methods studies. RESULTS: The role of the observer in simulation was explored and included observation to transform practice in self and observation to transform practice in others, namely peers in the nurse role in simulation. Application of the MMAT indicated that of the 18 studies included only 6 (33.3%) had a clear research question. Research aims or objectives were found in another six studies (33.3%). In this review 13 studies (72%) included answers to the research question or aim, three (17%) did not and in two (11%) it was impossible to tell. CONCLUSIONS: Results of this review indicate the paucity of research relating to nursing student's experience of clinical reasoning while observing simulation. Further, it highlights the value of nurse educators optimizing the observer role and maximizing learning by scaffolding observer activities within the simulation experience.

Effectiveness of using simulation in the development of clinical reasoning in undergraduate nursing students: A systematic review.

AIM/OBJECTIVE: This systematic review examines the effectiveness of undergraduate nursing students' using simulation to acquire clinical reasoning. BACKGROUND: Use of simulation to positively impact practice outcomes is an established method in nursing education. Clinical reasoning is a graduate capability that contributes to safe practice, so developing clinical reasoning requires explicit scaffolding in undergraduate contexts. While research has primarily evaluated specific clinical reasoning frameworks, variability in clinical reasoning definitions has obscured simulation efficacy for clinical reasoning acquisition. DESIGN: This review uses the Joanna Briggs Institute Systematic Reviews approach. METHODS: An electronic database search was conducted to identify studies published from May 2009 to January 2020 using a three-step search strategy. Selected papers were assessed by at least two independent reviewers for inclusion criteria, methodological validity, and data extraction. Ten studies using quasi-experimental designs involving 1532 students were included. RESULTS: Evidence regarding the effectiveness of simulation for undergraduate nursing students' acquisition of clinical reasoning was limited but of high quality. Review results showed no statistically significant gains in clinical reasoning with a single simulation exposure. Two emerging concepts, situation awareness and teamwork support the enhancement of clinical reasoning within simulation. In order to draw future conclusions on the efficacy of simulation to develop clinical reasoning, more research is warranted. CONCLUSIONS: New insights about team-based simulations and situation awareness were identified as integral for development of clinical reasoning in the context of simulation. More consistent use of terminology in the context of simulation research is also recommended.

Patient, Provider, and Clinic Characteristics Associated with Opioid and Non-Opioid Pain Prescriptions for Patients Receiving Low Back Imaging in Primary Care.

BACKGROUND: To describe characteristics of patients, providers, and clinics associated with opioid or non-opioid pain medication prescribing patterns for patients who received lower spine imaging in primary care clinics. METHODS: In these secondary analyses of the Lumbar Imaging with Reporting of Epidemiology (LIRE) study, a randomized controlled trial conducted in 4 health systems in the United States, we evaluated characteristics associated with receipt of pain medication prescriptions. The outcomes were receipt of prescriptions for opioid or, separately, non-opioid pain medications within 90 days after imaging. Among patients who received opioid or non-opioid prescriptions, we evaluated receipt of multiple prescriptions in the year following imaging. Mixed models were used to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: Compared with whites, patients identified as Asian (OR, 0.53; 95% CI, 0.51-0.56), Native Hawaiian/Pacific Islander (OR, 0.73; 95% CI, 0.64-0.83), multiracial (OR, 0.84; 95% CI, 0.71-0.98) or Black (OR, 0.92; 95% CI, 0.89-0.96) had significantly reduced odds for receiving prescriptions for opioids within 90 days. Patients identified as Native American/Alaska Native had greater odds for receiving prescriptions for non-opioid pain medications within 90 days (OR, 1.12; 95% CI, 1.01-1.24). Receipt of pain prescriptions 120 days before imaging was strongly predictive of subsequent receipt of pain prescriptions across all categories. CONCLUSIONS: After adjusting for factors that could affect prescribing, the strongest differences observed in pain-medication prescribing were across racial categories and for patients with previous pain prescriptions. Further research is needed to understand these differences and to optimize prescribing.

Comparison of simulation observer tools on engagement and maximising learning: a pilot study.

OBJECTIVES: This pilot study examined if the Clinical Reasoning Observer Worksheet (CROW) compared to a standard observer worksheet used during simulation, would enhance nursing students active learning behaviours and perceptions of clinical reasoning ability. METHODS: This pilot study was undertaken to test the design and processes for a future larger study and reports on preliminary evidence of efficacy of recruitment procedures and instrumentation in addition to student's learning outcomes. RESULTS: There was little overall difference in outcomes between groups who used either simulation observer worksheet. Overall, participants who used either worksheet perceived their ability to apply clinical reasoning to an episode of patient care increased. CONCLUSIONS: Modifications were identified as necessary for a larger study including changes to instrumentation, method of survey delivery and training of simulation facilitators. A more definitive evaluation will be achievable with a larger group of students in a main study with the suggested modifications.

Providing Epidemiological Data in Lumbar Spine Imaging Reports Did Not Affect Subsequent Utilization of Spine Procedures: Secondary Outcomes from a Stepped-Wedge Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect of inserting epidemiological information into lumbar spine imaging reports on subsequent nonsurgical and surgical procedures involving the thoracolumbosacral spine and sacroiliac joints. DESIGN: Analysis of secondary outcomes from the Lumbar Imaging with Reporting of Epidemiology (LIRE) pragmatic stepped-wedge randomized trial. SETTING: Primary care clinics within four integrated health care systems in the United States. SUBJECTS: 238,886 patients ≥18 years of age who received lumbar diagnostic imaging between 2013 and 2016. METHODS: Clinics were randomized to receive text containing age- and modality-specific epidemiological benchmarks indicating the prevalence of common spine imaging findings in people without low back pain, inserted into lumbar spine imaging reports (the "LIRE intervention"). The study outcomes were receiving 1) any nonsurgical lumbosacral or sacroiliac spine procedure (lumbosacral epidural steroid injection, facet joint injection, or facet joint radiofrequency ablation; or sacroiliac joint injection) or 2) any surgical procedure involving the lumbar, sacral, or thoracic spine (decompression surgery or spinal fusion or other spine surgery). RESULTS: The LIRE intervention was not significantly associated with subsequent utilization of nonsurgical lumbosacral or sacroiliac spine procedures (odds ratio [OR] = 1.01, 95% confidence interval [CI] 0.93-1.09; P = 0.79) or any surgical procedure (OR = 0.99, 95 CI 0.91-1.07; P = 0.74) involving the lumbar, sacral, or thoracic spine. The intervention was also not significantly associated with any individual spine procedure. CONCLUSIONS: Inserting epidemiological text into spine imaging reports had no effect on nonsurgical or surgical procedure utilization among patients receiving lumbar diagnostic imaging.

Assessment of Prognostic Value of Cystic Features in Glioblastoma Relative to Sex and Treatment With Standard-of-Care.

Glioblastoma (GBM) is the most aggressive primary brain tumor and can have cystic components, identifiable through magnetic resonance imaging (MRI). Previous studies suggest that cysts occur in 7-23% of GBMs and report mixed results regarding their prognostic impact. Using our retrospective cohort of 493 patients with first-diagnosis GBM, we carried out an exploratory analysis on this potential link between cystic GBM and survival. Using pretreatment MRIs, we manually identified 88 patients with GBM that had a significant cystic component at presentation and 405 patients that did not. Patients with cystic GBM had significantly longer overall survival and were significantly younger at presentation. Within patients who received the current standard of care (SOC) (N = 184, 40 cystic), we did not observe a survival benefit of cystic GBM. Unexpectedly, we did not observe a significant survival benefit between this SOC cystic cohort and patients with cystic GBM diagnosed before the standard was established (N = 40 with SOC, N = 19 without SOC); this significant SOC benefit was clearly observed in patients with noncystic GBM (N = 144 with SOC, N = 111 without SOC). When stratified by sex, the survival benefit of cystic GBM was only preserved in male patients (N = 303, 47 cystic). We report differences in the absolute and relative sizes of imaging abnormalities on MRI and the prognostic implication of cysts based on sex. We discuss hypotheses for these differences, including the possibility that the presence of a cyst could indicate a less aggressive tumor.

Deep neural network to locate and segment brain tumors outperformed the expert technicians who created the training data.

Purpose: Deep learning (DL) algorithms have shown promising results for brain tumor segmentation in MRI. However, validation is required prior to routine clinical use. We report the first randomized and blinded comparison of DL and trained technician segmentations. Approach: We compiled a multi-institutional database of 741 pretreatment MRI exams. Each contained a postcontrast T1-weighted exam, a T2-weighted fluid-attenuated inversion recovery exam, and at least one technician-derived tumor segmentation. The database included 729 unique patients (470 males and 259 females). Of these exams, 641 were used for training the DL system, and 100 were reserved for testing. We developed a platform to enable qualitative, blinded, controlled assessment of lesion segmentations made by technicians and the DL method. On this platform, 20 neuroradiologists performed 400 side-by-side comparisons of segmentations on 100 test cases. They scored each segmentation between 0 (poor) and 10 (perfect). Agreement between segmentations from technicians and the DL method was also evaluated quantitatively using the Dice coefficient, which produces values between 0 (no overlap) and 1 (perfect overlap). Results: The neuroradiologists gave technician and DL segmentations mean scores of 6.97 and 7.31, respectively ( p < 0.00007 ). The DL method achieved a mean Dice coefficient of 0.87 on the test cases. Conclusions: This was the first objective comparison of automated and human segmentation using a blinded controlled assessment study. Our DL system learned to outperform its "human teachers" and produced output that was better, on average, than its training data.

Days gained response discriminates treatment response in patients with recurrent glioblastoma receiving bevacizumab-based therapies.

BACKGROUND: Accurate assessments of patient response to therapy are a critical component of personalized medicine. In glioblastoma (GBM), the most aggressive form of brain cancer, tumor growth dynamics are heterogenous across patients, complicating assessment of treatment response. This study aimed to analyze days gained (DG), a burgeoning model-based dynamic metric, for response assessment in patients with recurrent GBM who received bevacizumab-based therapies. METHODS: DG response scores were calculated using volumetric tumor segmentations for patients receiving bevacizumab with and without concurrent cytotoxic therapy (N = 62). Kaplan-Meier and Cox proportional hazards analyses were implemented to examine DG prognostic relationship to overall (OS) and progression-free survival (PFS) from the onset of treatment for recurrent GBM. RESULTS: In patients receiving concurrent bevacizumab and cytotoxic therapy, Kaplan-Meier analysis showed significant differences in OS and PFS at DG cutoffs consistent with previously identified values from newly diagnosed GBM using T1-weighted gadolinium-enhanced magnetic resonance imaging (T1Gd). DG scores for bevacizumab monotherapy patients only approached significance for PFS. Cox regression showed that increases of 25 DG on T1Gd imaging were significantly associated with a 12.5% reduction in OS hazard for concurrent therapy patients and a 4.4% reduction in PFS hazard for bevacizumab monotherapy patients. CONCLUSION: DG has significant meaning in recurrent therapy as a metric of treatment response, even in the context of anti-angiogenic therapies. This provides further evidence supporting the use of DG as an adjunct response metric that quantitatively connects treatment response and clinical outcomes.