A command centre implementation before and during the COVID-19 pandemic in a community hospital.

INTRODUCTION: The objective of the study was to assess the effects of high-reliability system by implementing a command centre (CC) on clinical outcomes in a community hospital before and during COVID-19 pandemic from the year 2016 to 2021. METHODS: A descriptive, retrospective study was conducted at an acute care community hospital. The administrative data included monthly average admissions, intensive care unit (ICU) admissions, average length of stay, total ICU length of stay, and in-hospital mortality. In-hospital acquired events were recorded and defined as one of the following: cardiac arrest, cerebral infarction, respiratory arrest, or sepsis after hospital admissions. A subgroup statistical analysis of patients with in-hospital acquired events was performed. In addition, a subgroup statistical analysis was performed for the department of medicine. RESULTS: The rates of in-hospital acquired events and in-hospital mortality among all admitted patients did not change significantly throughout the years 2016 to 2021. In the subgroup of patients with in-hospital acquired events, the in-hospital mortality rate also did not change during the years of the study, despite the increase in the ICU admissions during the COVID-19 pandemic.Although the in-hospital mortality rate did not increase for all admitted patients, the in-hospital mortality rate increased in the department of medicine. CONCLUSION: Implementation of CC and centralized management systems has the potential to improve quality of care by supporting early identification and real-time management of patients at risk of harm and clinical deterioration, including COVID-19 patients.

Analysis of acquired resistance mechanisms to osimertinib in patients with EGFR-mutated advanced non-small cell lung cancer from the AURA3 trial.

Osimertinib, an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), potently and selectively inhibits EGFR-TKI-sensitizing and EGFR T790M resistance mutations. This analysis evaluates acquired resistance mechanisms to second-line osimertinib (n = 78) in patients with EGFR T790M advanced non-small cell lung cancer (NSCLC) from AURA3 (NCT02151981), a randomized phase 3 study comparing osimertinib with chemotherapy. Plasma samples collected at baseline and disease progression/treatment discontinuation are analyzed using next-generation sequencing. Half (50%) of patients have undetectable plasma EGFR T790M at disease progression and/or treatment discontinuation. Fifteen patients (19%) have >1 resistance-related genomic alteration; MET amplification (14/78, 18%) and EGFR C797X mutation (14/78, 18%).

Reducing Hospital Harm: Establishing a Command Centre to Foster Situational Awareness.

Humber River Hospital (HRH) implemented the world's first Command Centre (Generation 2) tiles to support early identification and real-time management of patients at risk of harm and clinical deterioration. To rescue patients and mitigate patient safety threats, situational awareness must be maximized. The development of the Generation 2 tiles was aligned with 18 out of 31 categories and clinical groupings of the Hospital Harm framework. Results of the 2019/20 Hospital Harm report (CIHI 2021) revealed that the overall rate of harm score for HRH was lower than that of peer hospitals, suggesting that there may be an association between the tiles and these patient outcomes.

Mindfulness-based stress reduction and cognitive function among breast cancer survivors: A randomized controlled trial.

BACKGROUND: Breast cancer (BC) survivors frequently report changes in cognition after chemotherapy. Mindfulness may benefit survivors by mitigating cancer-related cognitive impairment. As part of a larger study investigating the effects of mindfulness-based stress reduction (MBSR) for BC survivors living with neuropathic pain, the authors assessed whether MBSR would have an effect on cognitive outcomes. METHODS: Participants were randomized to an MBSR intervention group (n = 30) or a waitlist control group (n = 30). Cognitive assessments were administered at 3 time points: at baseline, 2 weeks, and 3 months post-MBSR in the intervention group and at equivalent time intervals for the control group. Multilevel models were used to assess whether MBSR significantly improved task performance at each time point. RESULTS: MBSR participants showed a significantly greater reduction in prospective and retrospective memory failures at 2 weeks postintervention. No effects of MBSR were noted for objective assessments. CONCLUSIONS: These results suggest that MBSR training reduces subjective (but not objective) memory-related impairments in BC survivors who receive treatment with chemotherapy. This study provides insight into a noninvasive intervention to ameliorate memory difficulties in BC survivors.

Cognitive dysfunction after out-of-hospital cardiac arrest: Rate of impairment and clinical predictors.

BACKGROUND: The purpose of this study was to evaluate the rate and domains of cognitive impairment in out-of-hospital cardiac arrest (OHCA) survivors, as compared to patients who experienced a myocardial infarction (MI), and to explore mechanisms and predictors of this impairment. METHODS AND RESULTS: OHCA survivors with "good" neurological recovery (i.e., Cerebral Performance Categories Scale ≤ 2) (n = 79), as well as a control group of MI patients (n = 69), underwent a comprehensive neuropsychological assessment. Forty-three percent of OHCA survivors were cognitively impaired (in the lowest decile on a global measure of cognitive functioning). Rates of impairment were approximately six times higher in the OHCA group than the MI group. Attention, memory, language and executive function were affected. Downtime was a significant predictor of cognitive impairment; the interaction between downtime and immediate intervention was significant such that, at short downtimes, receiving cardiopulmonary resuscitation (CPR) or defibrillation within 1 min of collapse predicted less cognitive impairment. CONCLUSIONS: OHCA survivors - even those with seemingly good neurological recovery - are at risk for cognitive impairment. Cognitive rehabilitation may be an important consideration post-OHCA.

Use of High-Reliability Principles in the Evolution of a Hospital Command Centre.

Hospitals and health systems across the world strive to achieve consistently safe care delivery and reduce patient harm. In November 2017, Humber River Hospital became one of the first hospitals in North America to implement a hospital command centre to manage patient access and flow. The command centre outputs relevant real-time data that have been integrated from multiple automated systems and uses predictive analytics to support early identification of patients at risk of harm and deterioration. The aim of this descriptive article is to present the conceptual development of Humber River Hospital's Command Centre.

Study protocol of the Aerobic exercise and CogniTIVe functioning in women with breAsT cancEr (ACTIVATE) trial: a two-arm, two-centre randomized controlled trial.

BACKGROUND: Up to 75% of women diagnosed with breast cancer report chemotherapy-related cognitive changes (CRCC) during treatment, including decreased memory, attention, and processing speed. Though CRCC negatively impacts everyday functioning and reduces overall quality of life in women diagnosed with breast cancer, effective interventions to prevent and/or manage CRCC are elusive. Consequently, women seldom receive advice on how to prevent or manage CRCC. Aerobic exercise is associated with improved cognitive functioning in healthy older adults and adults with cognitive impairments. Accordingly, it holds promise as an intervention to prevent and/or manage CRCC. However, evidence from randomized controlled trials (RCTs) supporting a beneficial effect of aerobic exercise on CRCC is limited. The primary aim of the ACTIVATE trial is to evaluate the impact of supervised aerobic exercise on CRCC in women receiving chemotherapy for breast cancer. METHODS: The ACTIVATE trial is a two-arm, two-centre RCT. Women diagnosed with stage I-III breast cancer and awaiting neo-adjuvant or adjuvant chemotherapy are recruited from hospitals in Ottawa (Ontario) and Vancouver (British Columbia), Canada. Recruits are randomized to the intervention group (aerobic exercise during chemotherapy) or the wait-list control group (usual care during chemotherapy and aerobic exercise post-chemotherapy). The primary outcome is cognitive functioning as measured by a composite cognitive summary score (COGSUM) of several neuropsychological tests. Secondary outcomes are self-reported cognitive functioning, quality of life, and brain structure and functioning (measured by magnetic resonance imaging (MRI)/functional MRI and electroencephalography). Assessments take place pre-chemotherapy (pre-intervention), mid-way through chemotherapy (mid-intervention/mid-wait period), end of chemotherapy (post-intervention/post-wait period; primary endpoint), 16-weeks post-chemotherapy, and at 1-year post-baseline. DISCUSSION: Aerobic exercise is a promising intervention for preventing and/or managing CRCC and enhancing quality of life among women diagnosed with breast cancer. The ACTIVATE trial tests several novel hypotheses, including that aerobic exercise can prevent and/or mitigate CRCC and that this effect is mediated by the timing of intervention delivery (i.e., during versus post-chemotherapy). Findings may support prescribing exercise during (or post-) chemotherapy for breast cancer and elucidate the potential role of aerobic exercise as a management strategy for CRCC in women with early-stage breast cancer. TRIAL REGISTRATION: The trial was registered with the ClinicalTrials.gov database ( NCT03277898 ) on September 11, 2017.

Exploratory Analyses of Cerebral Gray Matter Volumes After Out-of-Hospital Cardiac Arrest in Good Outcome Survivors.

BACKGROUND: Survival rates of cardiac arrest have increased over recent years, however, survivors may still be left with significant morbidity and functional impairment. A primary concern in cardiac arrest survivors is the effect of prolonged hypoxia/ischemia on the brain. The objectives of the present study were threefold: (1) to explore the effect of cardiac arrest on brain gray matter volumes (GMV) in "good outcome" survivors of out-of-hospital cardiac arrest (OHCA), (2) to examine the relationship between GMV, cognitive functioning and arrest factors, and (3) to explore whether OHCA patients differ from a group of patients with myocardial infarction (MI) uncomplicated by cardiac arrest and a group of healthy controls in terms of GMV. METHODS: Medically stable OHCA survivors with preserved neurological function and who were eligible for magnetic resonance imaging scanning (MRI; n = 9), were compared to: (1) patients who had experienced a MI (n = 19) and (2) healthy controls (n = 12). Participants underwent brain MRI on a 3T Siemens Trio MRI scanner and GMV was measured by voxel-based morphometry. A comprehensive neuropsychological assessment was also conducted. Global GMV was compared in the three samples using analyses of variance. The relationships between cognition and GMV were examined within group using correlations. RESULTS: The OHCA and MI groups showed a similar pattern of differences compared to the healthy control group. Both groups had decreased GMV in the anterior cingulate cortex, bilateral hippocampus, right dorsolateral prefrontal cortex, right putamen, and bilateral cerebellum. There were no significant differences in global or regional GMV between the OHCA and MI groups. Cognitive functioning was correlated with global GMV in the OHCA group; no such correlation was observed in the MI group. CONCLUSION: Regional atrophy was observed in OHCA and MI survivors, compared to a healthy control group, suggesting a common mechanism, presumably preexisting cardiovascular disease. Although similar regional volume differences were observed between the MI and OHCA groups, the relationship between GMV and cognition was only observed in OHCA survivors. We suggest the acute hypoxia/ischemia ensuing from the arrest may interact with diminished neural reserve in select brain areas to expose occult cognitive dysfunction.

Osimertinib in Patients With Epidermal Growth Factor Receptor Mutation-Positive Non-Small-Cell Lung Cancer and Leptomeningeal Metastases: The BLOOM Study.

PURPOSE: In this phase I study (BLOOM), osimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), was evaluated in patients with leptomeningeal metastases (LMs) from EGFR-mutated (EGFRm) advanced non-small-cell lung cancer (NSCLC) whose disease had progressed on previous EGFR-TKI therapy. PATIENTS AND METHODS: Patients with cytologically confirmed LM received osimertinib 160 mg once daily. Objectives were to assess confirmed objective response rate (ORR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), pharmacokinetics (PK), and safety. Additional efficacy evaluations included changes from baseline in CSF cytology and neurologic examination. Measurable lesions were assessed by investigator according to RECIST version 1.1. LMs were assessed by neuroradiologic blinded central independent review (BICR) according to Response Assessment in Neuro-Oncology LM radiologic criteria and by investigator. RESULTS: Forty-one patients were enrolled. LM ORR and DoR by neuroradiologic BICR were 62% (95% CI, 45% to 78%) and 15.2 months (95% CI, 7.5 to 17.5 months), respectively. Overall, ORR by investigator was 41% (95% CI, 26% to 58%), and median DoR was 8.3 months (95% CI, 5.6 to 16.5 months). Median investigator-assessed PFS was 8.6 months (95% CI, 5.4 to 13.7 months) with 78% maturity; median OS was 11.0 months (95% CI, 8.0 to 18.0 months) with 68% maturity. CSF tumor cell clearance was confirmed in 11 (28%; 95% CI, 15% to 44%) of 40 patients. Neurologic function was improved in 12 (57%) of 21 patients with an abnormal assessment at baseline. The adverse event and PK profiles were consistent with previous reports for osimertinib. CONCLUSION: Osimertinib showed meaningful therapeutic efficacy in the CNS and a manageable safety profile at 160 mg once daily in patients with EGFRm NSCLC and LM.

Confirmed Hypoallergenicity of a Novel Whey-Based Extensively Hydrolyzed Infant Formula Containing Two Human Milk Oligosaccharides.

BACKGROUND: We sought to determine whether an extensively hydrolyzed formula (EHF) supplemented with two human milk oligosaccharides (HMO) was tolerated by infants with cow's milk protein allergy (CMPA). METHODS: A whey-based EHF (Test formula) containing 2'fucosyl-lactose (2'FL) and lacto-N-neotetraose (LNnT) was assessed for clinical hypoallergenicity and safety. The Control formula was a currently marketed EHF without HMO. Children with CMPA, aged 2 months to 4 years, were assessed by double-blind, placebo-controlled food challenges (DBPCFC) to both formulas, in randomized order. If both DBPCFC were negative, subjects participated in a one-week, open food challenge (OFC) with the Test formula. Symptoms and adverse events were recorded. Hypoallergenicity was accepted if at least 90% (with 95% confidence intervals) of subjects tolerated the Test formula. RESULTS: Of the 82 children with CMPA that were screened, 67 (intention-to-treat [ITT] cohort-mean age 24.5 ± 13.6 months; range 2-57; 45 [67.2%] male) were randomized to receive either the Test or the Control formula during the first DBPCFC. Of these, 64 children completed at least one DBPCFC (modified intention-to-treat [mITT] cohort). Three children were excluded due to protocol deviations (per protocol [PP] cohort; n = 61). There was one allergic reaction to the Test, and one to the Control formula. On the mITT analysis, 63 out of 64 (98.4%; 95% CI lower bound 92.8%), and on the PP analysis 60 out of 61 (98.4%; 95% CI lower bound 92.5%) participants tolerated the Test formula, confirming hypoallergenicity. CONCLUSION: The whey-based EHF supplemented with 2'FL and LNnT met the clinical hypoallergenicity criteria and can be recommended for the management of CMPA in infants and young children.

Closed-Loop Medication System: Leveraging Technology to Elevate Safety.

BACKGROUND: Healthcare organizations have long been dependent on the vigilance of nurses to identify and intercept medication errors before they can adversely affect patients. New technologies have been implemented in an effort to reduce medication errors; however, few studies have evaluated the long-term effects of technology-based interventions in reducing medication errors. AIM: The aim of this study was to evaluate the effects of barcode medication administration (BCMA) and the closed-loop medication system (CLMS) interventions on medication errors and adverse drug event (ADE) rates. METHODS: An autoregressive integrated moving average model for interrupted time series design was used to evaluate the impact of the BCMA and CLMS interventions on the monthly reported medication error and ADE rates at Humber River Hospital between September 2013 and August 2018. Descriptive statistics were generated to evaluate the types of error and their gravity. RESULTS: A total of 1,712 medication errors and ADEs were reported in the five-year study period. The results of the interrupted time series indicated that the introduction of the BCMA intervention was associated with a statistically significant gradual decrease in reported medication error and ADE rates at 0.002 percentage points per month (p = 0.003). The introduction of the CLMS intervention was associated with an immediate absolute decrease in reported medication error and ADE rates of 0.010% (p = 0.020). CONCLUSIONS: The findings from this study support the adoption of both BCMA and CLMS interventions to prevent medication errors. Staged implementation of CLMS allows time for learning and incorporating barcode scanning. Interprofessional and cross-functional collaboration is necessary to successfully integrate the requirements of each respective discipline and service in the CLMS.

Smartphone Technology: Enabling Prioritization of Patient Needs and Enhancing the Nurse-Patient Relationship.

BACKGROUND: Mobile health (mHealth) is a rapidly growing field with the potential to transform healthcare delivery. Smartphone technologies have been developed and integrated into the patient call bell system for healthcare staff to receive calls; however, there is a lack of high-quality evidence to support the implementation and evaluate the effectiveness of these devices in a healthcare setting. AIM: The aim of this study is to explore nurses' perceptions of smartphone technology devices in enhancing the nurse-patient relationship and improving nursing workflows. METHODS: A semi-structured focus group and interviews were used to illicit nurses' experiences with smartphone technology. Interviews were audio recorded, transcribed and subjected to a content analysis to identify emerging themes from the data. RESULTS: Interviews with nurses provided insight into the benefits and challenges of smartphone use in the clinical setting. Multiple benefits were identified by nurse participants, including time management and convenience, prioritization, patient safety and enhancement of the nurse-patient relationship. CONCLUSION: There are multiple benefits of smartphone technology for both nurses and patients. Hospitals proposing to introduce smartphone technology need to educate patients and families about the clinical use of smartphones to avoid unfavourable perceptions. Smartphone technology must be interoperable with the electronic medical record to optimize interprofessional communication and exchange of patient information.

Violence Prevention: Technology-Enabled Therapeutic Intervention.

BACKGROUND: Nurses are disproportionately prone to experience incidents of violent victimization. Despite the vast literature on violence in healthcare settings, few studies have identified effective violence prevention interventions. AIM: The aim of the study was to explore the experiences of nurses regarding the implementation of technology-based violence prevention interventions. METHODS: Qualitative data were collected through semi-structured focus groups and interviews with 11 nurses at Humber River Hospital. Interviews were audiotaped, transcribed and subjected to a content analysis to identify core themes from the data. RESULTS: Three themes were identified: reassurance of safety, an increase in proactive measures and limitations of technology. Nurses held positive perceptions of the impact of technology-based interventions on violent incidents. The interventions were regarded as effective for the detection of potentially violent patients as well as for providing assistance from security staff when a violent incident occurs or appears imminent. However, nurses also acknowledged that patient-related violence was "unavoidable" and that technology cannot fully prevent violence from occurring. CONCLUSION: The findings from this study support the replication of these interventions in other healthcare facilities. Engaging staff, patients and families in this unique digital and technology-enriched environment has been critical for the successful implementation of the violence prevention electronic flagging system. Patient and family education and communication were essential for addressing concerns related to "labelling."

Patient Empowerment and Nursing Clinical Workflows Enhanced by Integrated Bedside Terminals.

BACKGROUND: Integrated bedside terminals (IBTs) were implemented at Humber River Hospital with the goal of supporting patient independence and autonomy and improving nursing workflows. The IBTs provide access to a range of convenience and entertainment services as well as access to personal health information. Due to the novelty of the technology, there is a paucity of empirical data on patients' use of, satisfaction with and perceptions of bedside terminals. AIM: The purpose of this study was to evaluate the impact of IBTs on patient empowerment and nursing workflows. METHODS: A mixed methods design was employed using a cross-sectional patient survey and semi-structured interviews with nurses. The patient survey assessed patient empowerment and satisfaction with the range of services offered through the IBT. Patient scores were summarized using descriptive statistics. Additionally, face-to-face interviews with nurses were used to illicit feedback regarding the IBTs' impacts on nursing workflows. RESULTS: In total, 113 patients and 11 nurses participated in the study. Analysis of patient satisfaction surveys indicated that the IBTs enhanced the patient experience and increased self-care management. Nurses reported that the IBTs helped patients feel comfortable and entertained and helped enhance the nurse-patient relationship. However, nurses also expressed concern that elderly patients were less inclined to use the IBT. CONCLUSION: The results from the present study suggest that the IBT system has the potential to empower patients and decrease demands on nurses. Patients' notes incorporated into the IBT may provide the necessary level of involvement to garner a greater sense of patient empowerment. The IBT does not replace the need for nurses to deliver information to patients in a manner that supports their trust.

Experiences of Nurses Working in a Fully Digital Hospital: A Phenomenological Study.

BACKGROUND: With the increasing development and integration of information and communication technology (ICT) into hospitals, there remains a lack of understanding of the impact of these technologies on the hospital's largest core users: nurses. Humber River Hospital (HRH), one of the first hospitals to completely integrate technology across all hospital systems and workflows, has sought to understand how ICTs have transformed the clinical working environment. OBJECTIVE: The aim of the study was to achieve a deeper understanding of the lived experiences of nurses practising in North America's first digital hospital. METHODS: The methodological approach was informed by van Manen's hermeneutic phenomenological methodology. Data were gathered through in-depth semi-structured interviews with eight nurses at HRH. Thematic analysis was conducted using the van Manen and Colaizzi methods of data analysis. RESULTS: Six thematic categories that formed the nurses' lived experiences of working in a digital environment were identified: safety, time, teamwork, technology failures, patient responses and adapting. CONCLUSION: Nurses at HRH identified six themes regarding their lived experiences working in a fully digital hospital that provide an insight into nurses' values and cause us to reflect on how we might use this information to further support nursing practice in the fully digital environment. Nurses at HRH seem to have normalized the nursing process within the fully digital environment. Technology appears to be viewed by nurses at HRH within the premise of nursing as an art, allowing patient responses to be acknowledged and incorporated into nursing workflows, and as a science, permitting safe care delivery. Overall, nurses perceived technology as being essential for patient safety and facilitating nursing practice. These findings offer insight into nurses' perception of ICTs, and as technological advancements continue to emerge, these findings will inform education, practice and policy.

Generational Differences in Hospital Technology Adoption: A Cross-Sectional Study.

BACKGROUND: The advancement of technological change within healthcare means that it is essential for nurses to have the necessary technological skills to deliver safe and efficient nursing care. Few studies have examined whether generational differences affect the adoption of technology within the healthcare system. AIM: The primary purpose of this study was to explore predictors that influence the adoption of technology. METHODS: In this cross-sectional study, nurses were asked to rate their level of competency on 20 key skills related to clinical technological devices (CTDs) in a self-administered questionnaire. Participants' demographic data and level of proficiency related to personal computer skills were also collected. Multiple linear regression analysis was used to examine whether demographic characteristics and personal computer skills predicted higher scores related to CTDs. RESULTS: Sixty-three nurses completed the questionnaires. Overall mean score for skills related to CTD was high at 3.74 (SD = 0.75) out of 5. Length of employment at the hospital and previous exposure to the technology used at the hospital (ß = 0.06, p = 0.021; ß = 0.054, p = 0.011, respectively) were the only variables significantly associated with higher CTD skills scores. Generational cohort, gender, years of nursing experience and self-rated proficiency related to personal computer skills were not related to higher CTD skills scores. CONCLUSION: The results of this study emphasize that consistent exposure to technology enhances its adoption. Generational cohort did not play a role in the perception of nurses' technology competency at Humber River Hospital.

Optimizing Nursing Practice through Integration of Best Practice Guidelines into Electronic Medical Records.

A commitment to best practice guidelines (BPGs) is crucial for ensuring the safety of patients. Recognizing the power of information technology, Humber River Hospital has integrated BPGs into the electronic medical record (EMR) infrastructure. The large-scale implementation institutes a uniform standard of care and ensures adherence to BPGs through a forcing function designed to require nurses to complete and document the necessary assessments. The initiative strengthens the audit process and provides the opportunity to identify long-term trends. The implications of the quality improvement initiative are discussed. Due to the widespread use of EMRs, the replication of this initiative is economically feasible in other healthcare settings.

Osimertinib Plus Durvalumab versus Osimertinib Monotherapy in EGFR T790M-Positive NSCLC following Previous EGFR TKI Therapy: CAURAL Brief Report.

INTRODUCTION: Osimertinib is a third-generation EGFR-tyrosine kinase inhibitor (TKI). Durvalumab is an anti-programmed death ligand 1 monoclonal antibody. The phase III open-label CAURAL trial (NCT02454933) investigated osimertinib plus durvalumab versus osimertinib monotherapy in patients with EGFR-TKI sensitizing and EGFR T790M mutation-positive advanced NSCLC and disease progression after EGFR-TKI therapy. METHODS: Patients were randomly assigned 1:1 to receive orally administered osimertinib (80 mg once daily) with or without durvalumab (10 mg/kg administered intravenously every 2 weeks) until progression. Treatment could continue beyond progression, providing clinical benefit continued (judged by the investigator). The amended primary objective was to assess the safety and tolerability of osimertinib plus durvalumab; efficacy was an exploratory objective. RESULTS: CAURAL recruitment was terminated early because of increased incidence of interstitial lung disease-like events in the osimertinib plus durvalumab arm from the separate phase Ib TATTON trial (NCT02143466). At termination of CAURAL recruitment, 15 patients had been randomly assigned to treatment with osimertinib and 14 to treatment with osimertinib plus durvalumab. The most common AEs were diarrhea (53% [grade ≥3 in 6% of patients]) in the osimertinib arm and rash (67% [grade ≥3 in 0 patients]) in the combination arm. One patient who had been randomized to the combination arm reported grade 2 interstitial lung disease while receiving osimertinib monotherapy (after discontinuing durvalumab therapy after one dose). The objective response rates were 80% in the osimertinib arm and 64% in the combination arm. CONCLUSION: Limited patient numbers preclude formal safety and efficacy comparisons between the two treatment arms. The combination of programmed cell death 1/programmed death ligand 1 inhibitors and EGFR-TKIs as therapy for NSCLC is not well understood, but it requires a careful approach if considered in the future.