bluuebunny/crossref_metadata_2025_split huggingface dataset:
EpiPen STAT: A quality improvement project for anaphylaxis management.
Authors: Sato-DiLorenzo Aya , Sendrowski Brendan , Vasquez Lora , Lithotomos Rena , Olezkiewicz Katarina , Shea Meghan 
Published: September 2022

319 Background: The medical oncology infusion unit at Beth Israel Deaconess Medical Center (BIDMC) experienced six anaphylactic reactions to chemotherapy between June 2000 and April 2021. EpiPen was delayed in all cases. In one instance, a patient experienced an emergency where she could not breathe, and her blood pressure continued to decrease. The covering nurse hesitated before administering an EpiPen. In follow-up, nurses reported a lack of confidence in administering an EpiPen. No licensed independent provider (LIP) was stationed in the infusion unit to guide nurses. The project's goal was to facilitate timely EpiPen administration, guided by the Translating Evidence into Practice (TRIP) framework. Methods: The project lead and the medical director revised the hospital’s chemotherapy reaction guidelines to highlight anaphylaxis management. They established an interdisciplinary project team with medical, nursing, pharmacy, and informatics representatives. Interventions, which started in November 2021, included a reaction management algorithm and PRN-reaction orders allowing nurses to initiate interventions while waiting for a LIP arrival. The unit educator provided EpiPen training, and the pharmacy leaders created an adverse drug reactions (ADR) kit—a locked box with necessary medications that followed BIDMC’s institutional algorithm to manage infusion reactions. Results: The project team collected post-intervention data between December 2021 and April 2022. Nurses reported twenty mild-to-severe chemotherapy reactions, including four anaphylactic episodes. Nineteen patients were discharged home on the day of reactions, and one patient required hospital admission for persistent symptoms. The management algorithm was followed in ten reactions (50%). Deviations from the algorithm were noted in eight cases, with the most frequent reason being smaller doses of antihistamine or corticosteroid. The algorithm was not applicable in two cases with atypical patient symptoms. In seventeen of the twenty reactions (85%), PRN-reaction orders were available in the electronic ordering system. The ADR kit was used in all reactions. In two of the four anaphylactic reactions, EpiPen was administered immediately following hypotension or hypoxia. In the remaining two cases, it was administered for persistent symptoms. Conclusions: The project facilitated EpiPen administration. The critical steps were systemic analysis of barriers, problem-solving with the TRIP framework, and engagement of frontline nurses. In our next step, we will consider narrowing the scope to managing acute hypotension or hypoxia. The narrower scope will enable targeted education about emergency management, potentially at the hospital’s simulation center. To ensure every patient has an order, the department could consider a standing EpiPen order for hemodynamically unstable patients.
Prevention and management of cetuximab-related hypomagnesemia.
Authors: Tejpar Sabine , Taniguchi Hiroya , Falco Agustín , Velthuis Erica , Valencia Pineda Christian , Mesia Ricard 
Published: September 2022

321 Background: Cetuximab is an epidermal growth factor receptor monoclonal antibody indicated for the treatment of squamous cell carcinoma of the head and neck and RAS wild-type metastatic colorectal cancer. Hypomagnesemia is a reversible adverse event associated with cetuximab treatment. Here, we provide the key considerations in prevention and management of cetuximab-related hypomagnesemia events in clinical practice. Methods: A PubMed literature search was conducted for articles published between 18 March 2012 and 18 March 2022 using cetuximab and hypomagnesemia as keywords. Of the 75 articles retrieved, 20 were considered relevant and are included here.Articles were excluded if they focused on hypomagnesemia-associated clinical benefits. Data were summarized and grouped into the following categories: risk and risk factors; monitoring; prevention; and management. Results: The relative risk of grade 3/4 hypomagnesemia following cetuximab therapy appears to be approximately 1.5 times higher for colorectal cancer compared with head and neck cancer. Several risk factors have been identified including age, comorbidities, treatment duration, baseline electrolyte levels, concomitant platinum-based chemotherapy, and polypharmacy. Although the frequencies of hypomagnesemia events vary between the studies identified, data from the included meta-analyses suggest that the incidence of grade 3/4 hypomagnesemia is around 4% among patients receiving cetuximab therapy. Early and regular monitoring of magnesium levels is recommended ideally every 4 to 8 weeks, especially in patients at high risk of serious complications, and up to 8 weeks following treatment cessation. Proposed proactive prophylactic interventions include magnesium supplementation for patients with baseline magnesium levels < 1.8 mg/dL, to prevent severe hypomagnesemia. The management approach depends on the degree of hypomagnesemia, the symptoms and risk factors, and may include supplementation with oral magnesium salts and/or parenteral forms; intravenous forms may be preferred due to low bioavailability and gastrointestinal adverse events related to oral supplements. While recommendations for initiating magnesium replacement in grade 1 (> 1.2 mg/dL) and grade 2 (0.91.2 mg/dL) hypomagnesemia events vary, magnesium supplementation should be given to patients with grade 3 (0.70.9 mg/dL) or grade 4 (< 0.7 mg/dL) hypomagnesemia, due to high risk of serious adverse cardiac events. If magnesium levels do not improve or continue to decrease despite supplementation, a pause in cetuximab administration may be considered. Conclusions: Hypomagnesemia is a reversible and manageable cetuximab-related adverse event and should not interfere with treatment outcomes. A periodic check of magnesium levels during treatment with cetuximab is recommended.
Better together: Implementation of a patient safety solution committee at an academic cancer center.
Authors: Bhardwaj Aarti Sonia , Parra Jessica , Hussa Marissa , Mato John , Tsembelis Brooke , Jain Priya , Smith Cardinale B. 
Published: September 2022

325 Background: The Mount Sinai Health System oncology service line initiated a patient safety solution (PSS) committee to comprehensively review reported safety events in order to provide safe and high-quality care. This multi- and interdisciplinary committee creates a safe space to report events that caused harm, near misses and empowers all staff to be part of a just culture of safety. Here we describe the process and report on outcomes. Methods: The committee consists of nurses, advanced practice providers, physicians, pharmacists, social workers, IT analysts, and administrative staff, representing the oncology service line across inpatient and outpatient. Any staff member can enter incident reports that they believe warrant review into a software application. Our quality team reviews all events and then selects cases in which harm or near-harm was involved, for in-depth investigation to be presented at bi-weekly PSS meetings where cases are discussed, root causes are evaluated, and solutions are proposed. For each case, the committee votes on standard of care using the Continuous Quality Improvement (CQI) Classifications tool. Often, smaller workgroups are formed to carry out quality improvement (QI) projects and corrective action plans (CAPs). All case data, including patient demographics, case summaries, outcomes, and ongoing plans are tracked using a custom REDCap survey. A question about the role of bias was added in December 2020 (yes/no/not enough information). Results: From January 2021 until March 2022, a total of 115 events were reviewed with an average of 23 events reviewed each quarter. Sociodemographic information on patients reviewed is in table. 41% of cases involved the inpatient setting. Issues with medication comprised 47% of cases, followed by patient identification (11%) and lack of escalation (10%). The most common CAPs involved education and counselling (47%), development of new policies (22%) and escalation to leadership (8%). In total, we have developed 29 new workflows, policies, and guidelines. Bias was felt to be involved 25% of the time, no bias 5% and not enough information 43% of the time. Conclusions: This process illustrates the importance of a multi- and interdisciplinary and transparent approach to clinical case and peer review to ensure the highest level of care. The outcomes of this committee have led us to optimize current policies, create new policies and procedures, new rounding structures and place a renewed focus on bias and discrimination.[Table: see text]
Number needed to harm (NNH) in patients with non-metastatic, castration-resistant prostate cancer (nmCRPC): A final analysis from the darolutamide (D), enzalutamide (E), and apalutamide (A) clinical trials.
Authors: George Daniel J. , Waldeck A. Reginald , Guo Helen , Upton Alexander J. 
Published: September 2022

326 Background: Second generation androgen receptor inhibitors (ARI) D, A and E, approved for the treatment of nmCRPC, offer benefit in overall survival (OS) and metastasis-free survival (MFS), but do so with different risk-benefit profiles. Contextualizing risks of adverse events (AEs), or harm to patients, can be challenging. NNH is a trial-based measure that evaluates the number of patients who need to receive treatment before a harmful outcome occurs with the intervention, compared to the control. Thus, a higher NNH reflects a lower incremental likelihood of harm. This study is an update to a previous NNH analysis, utilizing final data from the ARI randomized controlled trials (RCTs). Methods: MEDLINE and EMBASE were searched for relevant RCTs. AEs occurring in ≥5% of either RCT arm were extracted from the final ARAMIS (D), SPARTAN (A) and PROSPER (E) publications. NNH by AE (all grade, grade 3 & 4) were calculated over the duration of each RCT based on reported rates, using the inverse of the absolute risk increase [1 / (experimental AE rate - control AE rate)]. An exploratory analysis considered the application of results to a US population, assuming trial-based AE rates to be representative of real-world rates. Results: Results show a trend of higher (i.e., favorable) NNH for AEs for D in ARAMIS across all grade and grade 3-4 AEs (Table), indicating a lower likelihood of incremental harm across AEs including fatigue, falls, hypertension and fracture for D versus A and E. Focusing on fatigue, fall and fractures, and selecting treatment with the highest (D) and lowest (A or E) NNH for an estimated 24,000 US high risk nmCRPC patients annually, treatment with D would translate to 4,073 fewer all-grade fatigue events, 2,928 fewer falls, and 2,383 fewer fractures compared to treatment with A (falls) or E (fatigue or fracture). Conclusions: The findings show a consistent trend of higher NNH (favorability) for D compared to A and E. The differences in their respective AE profiles are noteworthy not only for patients, but also for healthcare systems considering the overall risk-benefit amongst these three ARIs. Comparing D, A, and E directly in a single study may further inform their comparative profiles.[Table: see text]
Informed consent in clinical trials: Implementing methods to improve patient understanding in cancer research—A quality improvement initiative in a sarcoma trials unit.
Authors: Goggin Caitriona , Al-Badri Bader , Stansfeld Anna , Barquin Elizabeth , Durand Benjamin , Nguyen Thuy-Giang , Mahalingam Preethika , Ayeni Eniola , Napolitano Andrea , Zaidi Shane , Miah Aisha , Jones Robin Lewis , Benson Charlotte 
Published: September 2022

335 Background: Clinical trials are considered the cornerstone of improving outcomes for cancer patients. The understanding of an individual patient of the trial on which they are enrolled can vary significantly, with some studies demonstrating poor patient understanding of their involvement in trials. This exploratory study aimed to improve patient understanding of clinical trials and patient experience of the informed consent process by implementing measures to present complex trial information in alternative formats. Methods: The project was undertaken in a sarcoma trials unit in a specialist cancer treatment centre. Baseline knowledge was assessed using an adapted version of the Quality of Informed Consent (QuIC) questionnaire. A decision-aid was created following focus group discussions with stakeholders, focussing on key trial questions for patients, such as consent, the research description, risks, benefits, and alternatives to the trial. A patient education video was produced by the research team, explaining general aspects of clinical trials in patient-friendly language. The decision-aids and videos were distributed during the informed consent process of trial recruitment over a 12-week period. The patient group was assessed with post-intervention questionnaires. Statistical analysis was descriptive due to the small numbers. Results: Thirty sarcoma patients participated in the project, including baseline assessment of 15 patients previously enrolled on study, and 15 patients considering participation in a trial who underwent the intervention. 100% (n = 15) of the interventional group found the video and decision-aid useful. 60% (n = 18) of patients had a university level education, indicating a well-educated population. A pre- and post-intervention comparison demonstrated an improved understanding of 10 key elements of clinical trial information as shown in Table. Conclusions: Our exploratory study has shown that patient education tools including decision-aids and patient videos can be successfully implemented to help improve patient understanding of clinical trial information and may be of benefit in other trials units. Further larger studies are required to confirm these findings.[Table: see text]
Improving the chemotherapy unit by implementing Medication Early Release Project (MERP).
Authors: Alzahrani DR.Mohsen 
Published: September 2022

343 Background: The outpatient oncology infusion suite is a very busy unit and sees an average of 60 to 70 patients per day. A limited number of treatment chairs, one pharmacy hood for biohazardous drug preparation and various other factors have resulted in long waiting times for patients before starting their treatment. To improve the patient experience and to try and alleviate pressure on the preparation pharmacy and nursing services during peak times we investigated the feasibility of an early medication preparation and release program. This would enable rapid admission, assessment and administration of the pre-prepared treatment and in turn have a positive impact on patient flow and equalize the pressure felt by the preparation pharmacy. Methods: In this quality improvement project we formed a committee that met on biweekly basis, this committee included representatives from nursing, quality, pharmacy, data analysis and was led by a consultant physician. We studied the baseline data of patient waiting times from January to March 2019 and factors that caused patient delays in being treated. Patient selection criteria were prepared to identify patients that could safely have their medication released early in the morning at 7 am enabling pharmacy to dispense at 8 am without their actual presence being required in the infusion suite. Multiple PDSA cycles with several process changes and educational interventions were implemented to achieve our goal. Results: Baseline data identified that the average waiting time was 2.27 hrs a with a range of waiting times between 33 minutes to 5.07 hrs. After the first intervention the average waiting time reduced to 1 hr. and 24 minutes through each PDSA cycle we could see small improvements in the average time. The major breakthrough appeared following the intensive patient education program and enforcement of strict compliance with the criteria in selecting patients appropriate for the early release program. team sustained and keep average waiting time within control limit of less than one hour from 8th month of the program until January 2021 to be 33 minutes. We identified drug wastage for patients who did not show up as a balancing measure. We were successful in reducing the drug wastage by applying several changes and patient education measures and reached zero wastages. Patient satisfaction survey were conducted they were satisfied after their enrolment in the program. Conclusions: Positive impact has been seen with a significant reduction in the average waiting time from 2.24 hours to 41 minutes exactly. With further interventions relating to patient education and root cause analysis of any patients who are spending longer than necessary in the waiting area we aim to improve this further, an expansion of the pharmacy's capacity to prepare more than 10â€“15 preparations between 7â€“8 am may give rise to a further expansion of the criteria for patients to be included in the MERP pathway.
Implementing process improvements to enhance distress screening and management.
Authors: Stout Nicole Lynn , Street Crystal , Policicchio Patricia , Summers Joe , Duckworth Adrienne 
Published: September 2022

352 Background: While distress is prevalent among individuals living with cancer, distress management has not been optimized across cancer care delivery despite standards for screening. This manuscript describes the development of an enhanced Distress Thermometer(eDT) and shares the process for implementing the (eDT) across a cancer institute by highlighting process changes and improvements at the provider, system, and clinic levels. Methods: Focus groups and surveys were used at the provider-level to outline the problem space and to identify solutions to improve distress screening and management. Through stakeholder engagement, an eDT was developed and rolled out across the cancer institute. The eDT included pull down menus for each of the DT problem areas to provide detailed context of the specific issue. EHR infrastructure changes were implemented at the system-level to improve the use of the distress screening findings and generate automated referrals for specialty services. Clinic-level workflows were adapted to improve screening and distress management using the eDT. Patient-level data was collected to examine severity of distress and referral pathway utilization comparisons between original DT and eDT. Results: Stakeholder focus group participants (n = 17) and survey respondents (n = 13) found the eDT to be feasible and acceptable for distress identification and management. System-level technical EHR changes resulted in high accuracy with patient identification for distress management and 100% of patients with moderate to severe distress were connected directly to an appropriate specialty provider. Clinic-level workflow changes to expand eDT use improved compliance rates with distress screening from 86% to 98% over a 1 year period. We are currently analyzing utilization data based on distress screening at the patient level and will provide these results in the final presentation. Conclusions: An eDT that provides more context to patient-reported problems improved identification of referral pathways for patients experiencing moderate to high distress during cancer treatment and enhanced overall clinical use of the eDT. Combining process improvement interventions across multiple levels in the cancer care delivery system enhanced the success of this project. These processes and tools could support improved distress screening and management across cancer care delivery settings.
Screening for supportive care services in the neuro-oncology patient: A quality improvement project.
Authors: Cermin Katherine S. , Salazar Mary , Kelly William 
Published: September 2022

355 Background: On average, 80 to 85% of patients diagnosed with brain tumors qualify for supportive care under the American Society of Clinical Oncology (ASCO) recommendations. The National Comprehensive Cancer Network (NCCN) recommends routine screening, yet in our experience only 39% are screened in-clinic and 8.7% qualifying are referred. Evidence within the literature suggests consistent patient symptom screening and reflexive supportive care referral leads to improved quality of life and treatment plan adherence, and reduced symptom burden, healthcare costs, and less aggressive end-of-life care. This QI/IS project sought to improve quality of life through increased symptom screening via the Edmonton Symptom Assessment Scale (ESAS) and initiation of supportive care referral in Neuro-Oncology patients. Methods: Institutional Review Board (IRB) appraisal deemed this project non-regulatory research. A retrospective chart review assessed pre-implementation consistency of patients screened using the ESAS tool, the number indicating symptom burden and supportive care qualification, and if referral was placed. The Plan-Do-Study-Act (PDSA) Framework guided implementation and process evaluation. Interventions focused on improving ESAS use to identify patients who would benefit from supportive services and decreasing barriers to supportive care such as supportive care misinformation, screening burden, and documentation. From October 2021 to March 2022, data collection included the patient demographics ethnicity, age, diagnosis, and encounter date, as well as patient ESAS scores and supportive care referrals placed. Results: Over a five-month implementation period, 357 ESAS symptom burden tools were completed and documented out of 378 patient encounters in the neuro-oncology outpatient clinic. Clinic ESAS completion rates increased from 39.3% to 94.4%. Symptom burden qualifying for supportive care referral improved in 18% (N = 66), down from 31.2% (N = 102) of patients. Of patients qualifying, referrals increased from 4.9% (N = 5) to 10.7% (N = 7). Conclusions: Consistent use of a patient screening process led to an increase in the number of identified patients with significant symptom burden and referral for supportive care services, meeting all project goals. Initially, qualified rates increased with improved screening processes and clinic education, then steadily decreased to indicate better symptom control. This suggests a process capable of meeting the screening needs of oncology patients and minimal resource needs to maintain long-term sustainability. Future projects aimed at supportive care access and resource availability are recommended.[Table: see text]