Improving oral chemotherapy adverse event reporting: Listening to pediatric oncology patients and parents.

2017 ◽  
Vol 35 (8_suppl) ◽  
pp. 45-45
Author(s):  
Jessica A. Zerillo ◽  
Constance Barysauskas ◽  
Paul J. Catalano ◽  
Joseph O. Jacobson ◽  
Amy Billett
Keyword(s):  
Adverse Events ◽  
Pediatric Oncology ◽  
Adverse Event Reporting ◽  
Oral Chemotherapy ◽  
Near Miss ◽  
Ambulatory Setting ◽  
Near Misses ◽  
Pediatric Hematology ◽  
The Past ◽  
Patient Reported

45 Background: Medication-related adverse events and near misses are underreported, particularly in the ambulatory setting. Our aim was to assess pediatric oncology parent and patient-reported oral chemotherapy errors and near misses. Methods: A survey of parent and patient-reported oral chemotherapy errors and near misses over the past month was developed and validated in a subgroup and administered to parents/patients at an academic pediatric hematology-oncology clinic. Parents and patients were included if the patient received any commercially available oral chemotherapy agent within the past month, dispensed by an onsite retail pharmacy, and agreed to participate. Results: Forty-eight of 69 parents and 11 of 17 patients responded (ten from the same household). Fifteen of 59 respondents (25%) reported at least one event, miss, or error (twelve (25%) parents and three (27%) patients). Of five events described by parents and patients of the same household, one was co-reported. Of the errors that occurred in the home, the most common were missed (n=5, 8%) and late (n=3, 5%) doses. Forty-six percent of respondents did not report events to the medical team. Two respondents perceived minor harm as a result of the event. Conclusions: Patients and parents are willing to share information about oral chemotherapy-related adverse events and near misses. Twenty-five percent of respondents noted an oral chemotherapy event, near miss, or error over the preceding month. Importantly, many of these events were unreported to care teams. Missed doses were the most common safety event, and interventions should target this need.[Table: see text]

Building a new process: Nursing verification of pediatric oral chemotherapy.

2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 199-199 ◽  
Author(s):  
Jessica A. Zerillo ◽  
Erin Santacroce ◽  
Mary Ann Zimmerman ◽  
Melissa Freeman ◽  
Teresa Lau Greenberg ◽  
...  
Keyword(s):  
Pediatric Oncology ◽  
Treatment Plan ◽  
Drug Dose ◽  
Oral Chemotherapy ◽  
Near Miss ◽  
Patient Portal ◽  
Prescription Error ◽  
Vulnerable Patients ◽  
New Process ◽  
Treatment Plans

199 Background: While team-based safety checks ensure safe prescribing of parenteral chemotherapy, oral chemotherapy is usually prescribed by a single clinician. With the growing use of oral chemotherapy, processes are needed to protect these vulnerable patients from prescription errors. Methods: A team of nurses, clinicians, pharmacists and administrators developed a new process and checklist for nursing verification of oral chemotherapy prescriptions at Dana-Farber’s pediatric neuro-oncology program. Prescriptions are verified against the treatment plan by two pediatric oncology nurses. The verification checklist includes drug, dose with any modifications, height and weight, laboratory values and patient instructions. When available, the prescription bottle is also verified. Data was collected over a three-month pilot period. Results: From 6/18/15-9/16/15, 56 prescription verifications occurred. Verification rate of on-site retail pharmacy filled prescriptions was 47% (32/68 prescriptions). Median time for verification was 20 minutes (IQR 15, 40) per nurse. Nurses identified problems outside of prescription verification, including missing prior authorizations and unclear treatment plans. Medication bottles were not routinely available for verification. One identified near miss would have resulted in an 80% under-dose of everolimus. Conclusions: Prescription verification by nursing in a pediatric oncology clinic was feasible. While it was successful in identification of one medication error before it reached the patient, only 47% of prescriptions were verified. Since prescription bottles are usually obtained after a visit, verification of the actual bottles will require new workflows, such as additional clinic visits or uploading a picture via the patient portal. Involving the nurse in the review of oral chemotherapy not only identified a prescription error, but also highlighted issues within other aspects of patients’ care, including inconsistent documentation of the treatment plan. The inclusion of nursing in the review and management of oral chemotherapy has the potential to improve safety and outcomes for these patients.

scholarly journals Patient Reported Outcomes in Pediatric Cancer Registration Trials: A U.S. Food and Drug Administration Perspective

2021 ◽  
Author(s):  
Meena N Murugappan ◽  
Bellinda L King-Kallimanis ◽  
Gregory H Reaman ◽  
Vishal Bhatnagar ◽  
Erica G Horodniceanu ◽  
...  
Keyword(s):  
Adverse Events ◽  
Pediatric Oncology ◽  
Pediatric Cancer ◽  
Additional Patient ◽  
Cancer Registration ◽  
Regulatory Review ◽  
Product Labeling ◽  
Patient’S Perspective ◽  
Benefit Risk Assessment ◽  
Patient Reported

Abstract Pediatric patient-reported outcome (PRO) data can help inform the U.S. Food and Drug Administration’s (FDA) benefit-risk assessment of cancer therapeutics by quantifying symptom and functional outcomes from the patient’s perspective. This study assessed use of PROs in commercial pediatric oncology trials submitted to FDA for regulatory review. FDA databases were searched to identify pediatric oncology product applications approved between 1997 and 2020. Sponsor-submitted documents were reviewed to determine whether PRO data were collected, which instruments were used, and the quality of collected data (sample size, completion rates, and use of fit-for-purpose instruments). The role of PROs in each trial (endpoint hierarchy) was also recorded, along with whether any PRO endpoints were included in product labeling. Seventeen pediatric oncology applications were reviewed, 4 included PRO data: Denosumab, Tisagenlecleucel, Larotrectinib, and Selumetinib. In these 4 instances, PROs served as exploratory endpoints and were not incorporated in product labeling. Trials collecting PRO data were Phase II or Phase I/II single-arm studies with sample sizes of 28 to 88 patients. Symptomatic Adverse Events were characterized using clinician-reported Common Terminology Criteria for Adverse Events (CTCAE) without additional patient self-report. PROs were infrequently utilized in pediatric cancer registration trials. When used, PRO data were limited by lack of a clear research objective and corresponding prospective statistical analysis plan. Contemporary PRO symptom libraries such as the National Cancer Institute’s Pediatric PRO-CTCAE may provide an opportunity to better evaluate the occurrence and impact of symptomatic Adverse Events, from the patient’s perspective, in pediatric oncology trials.

Self-perceived sleep during the Maintenance of Wakefulness Test: how does it predict accidental risk in patients with sleep disorders?

SLEEP ◽  
2021 ◽  
Author(s):  
Patricia Sagaspe ◽  
Jean-Arthur Micoulaud-Franchi ◽  
Stéphanie Bioulac ◽  
Jacques Taillard ◽  
Kelly Guichard ◽  
...  
Keyword(s):  
Sleep Disorders ◽  
Sleep Latency ◽  
Near Miss ◽  
Restless Leg Syndrome ◽  
Multivariate Logistic Regression ◽  
Near Misses ◽  
The Past ◽  
Maintenance Of Wakefulness Test ◽  
Driving Risk ◽  
Idiopathic Hypersomnia

Abstract Study Objectives To determine whether the feeling of having slept or not during the Maintenance of Wakefulness Test (MWT) is associated with the occurrence of self-reported sleep-related traffic near misses and accidents in patients with sleep disorders. Methods This study was conducted in patients hospitalized in a French sleep center to perform a 4*40 min MWT. Relationship between mean sleep latency on the MWT, feeling of having slept or not during MWT trials and sleep-related near misses and accidents reported during the past year was analyzed. Results 192 patients suffering from OSAS, idiopathic hypersomnia, narcolepsy, restless leg syndrome or insufficient sleep syndrome were included. 165 patients presented no or one misjudgment of feeling of having slept during MWT trials while 27 presented more than two misjudgments. Almost half of the latter (48.1%) reported a sleepiness-related traffic near miss or accident in the past year versus only one third (27.9%) for the former (P<.05). Multivariate logistic regression showed that patients with more than two misjudgments had a 2.52-fold (95% CI, 1.07–5.95, P<.05) increase in the risk of reporting a sleepiness-related near miss/accident. Conclusions Misjudgment in self-perceived sleep during the MWT is associated with the occurrence of self-reported sleepiness-related traffic near misses and accidents in the past year in patients suffering from sleep disorders. Asking about the perception of the occurrence of sleep during the MWT could be used to improve driving risk assessment in addition to sleep latencies.

Sex differences in adverse event reporting in SWOG chemotherapy, biologic/immunotherapy, and targeted agent cancer clinical trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11588-11588 ◽  
Author(s):  
Joseph M. Unger ◽  
Riha Vaidya ◽  
Kathy S. Albain ◽  
Michael Leo LeBlanc ◽  
Lori M. Minasian ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Sex Differences ◽  
Adverse Events ◽  
Targeted Therapies ◽  
Patient Reported Outcome ◽  
Adverse Event Reporting ◽  
Multiple Treatment ◽  
Increased Risk ◽  
Patient Reported ◽  
Grade 3

11588 Background: Women have more adverse events (AEs) from chemotherapy than men, but few studies have explored sex differences in biologic/immunotherapies (BIs) or targeted therapies. We examined subjective (symptomatic) and objective AEs by sex across different treatments. Methods: We analyzed drug-related severe (grade 3) or worse AEs by sex in SWOG phase II and III clinical trials conducted between 1980-2018, excluding sex-specific cancers. AE codes and grade were categorized using the Common Terminology Criteria for Adverse Events (CTCAE). Subjective or symptomatic toxicities were defined as those aligned with the NCI’s new Patient-Reported Outcome (PRO) CTCAE; lab-based or physician-determined AEs were designated as objective. Multivariable logistic regression was used, adjusting for age, race, and disease prognosis. Thirteen symptomatic and 19 objective AE categories were examined. Results: In total, 36,397 patients (women, 13,907 [38.2%]; men, 22,490 [61.8%]) experiencing 522,835 AEs on 297 trials with 385 treatment arms were analyzed. Overall, 29.1% (n = 10.860) had severe or worse toxicity. Women experienced an increased risk of severe symptomatic AEs for BIs (OR = 1.53, 95% CI: 1.32-1.78, p < .0001), chemotherapy (OR = 1.31, 95% CI: 1.24-1.39, p < .0001), and targeted therapies (OR = 1.23, 95% CI: 1.06-1.43, p = .008). Women also had an increased risk of severe objective AEs for BIs (OR = 1.53, 95% CI: 1.32-1.78, p < .0001), chemotherapy (OR = 1.35, 95% CI: 1.28-1.43, p < .0001), but not targeted therapies (OR = 1.08, 95% CI: 0.94-1.25, p = .28). Across all treatments, sex differences were greater for hematologic (OR = 1.29, 95% CI: 1.24-1.35, p < .0001) v. non-hematologic (OR = 1.13, 95% CI: 1.08-1.18, p < .0001) objective AEs. Conclusions: The greater severity of both symptomatic and objective – especially hematologic – AEs in women across multiple treatment paradigms indicates broad-based sex-differences exist. This could be due to AE reporting, pharmacogenomics of drug metabolism and disposition, total dose received, and/or adherence to therapy. Particularly large sex differences were observed for patients receiving BIs, suggesting studying AEs from these agents is a priority.

scholarly journals An Assessment of an Educational Intervention on Resident Physician Attitudes, Knowledge, and Skills Related to Adverse Event Reporting

2010 ◽  
Vol 2 (2) ◽  
pp. 188-194 ◽  
Author(s):  
Barbara G. Jericho ◽  
Rosalie F. Tassone ◽  
Nikki M. Centomani ◽  
Jennifer Clary ◽  
Crescent Turner ◽  
...  
Keyword(s):  
Adverse Event ◽  
Patient Safety ◽  
Adverse Events ◽  
Educational Intervention ◽  
Adverse Event Reporting ◽  
Physician Attitudes ◽  
Event Reporting ◽  
Near Misses ◽  
Knowledge And Skills ◽  
Process Improvements

Abstract Objective Reporting and learning from events linked to patient harm and unsafe conditions is critical to improving patient safety. Programs that engage resident physicians in adverse event reporting can enhance patient safety and simultaneously address all 6 Accreditation Council for Graduate Medical Education competencies. Yet fewer than 60% of physicians know how to report adverse events and near misses, and fewer than 40% know what to report. Our study evaluated the effect of an educational intervention on anesthesiology residents' attitudes, knowledge, and skills related to adverse event reporting and the associated follow-up. Methods In a prospective study, anesthesiology residents participated in a training program focused on the importance of reporting methods and on reporting adverse events for patient safety. Quarterly adverse event reports were analyzed retrospectively for 2 years before the intervention and prospectively for 7 quarters after the intervention. Residents also completed a survey, before and 1 year after the intervention, that evaluated their attitudes, experience, and knowledge regarding adverse event reporting. Results After the intervention, the number of adverse event reports increased from 0 per quarter to almost 30 per quarter. We identified several categories of harm events, near misses, and unsafe conditions, including reports of disruptive providers. Of the harm events associated with invasive procedures, more than half were associated with lack of attending physician supervision. We also observed significant progress in the residents' ability to appropriately file a report, improved attitudes regarding the value of reporting and available emotional support, and a reduction in the perceived impediments to reporting. Conclusions An educational intervention increased the number of adverse event reports submitted by anesthesiology residents, improved their attitudes about the importance of reporting, and produced a source for learning opportunities and process improvements in the delivery of anesthesia care.

scholarly journals Current Status of Pediatric Oncology in Iran

2017 ◽  
Vol 2 (4) ◽  
pp. 71
Author(s):  
Mardawig Alebouyeh
Keyword(s):  
Pediatric Oncology ◽  
The State ◽  
Current Status ◽  
Hematological Disorders ◽  
Pediatric Hematology ◽  
The Past ◽  
Almost All

The pediatric hematology and oncology (PHO) services in Iran have steadily improved during the past 10 years.Today, we have specialized PHO services in almost all major cities throughout the country, where 43 board-certified or eligible pediatric hematologist-oncologists are currently giving care to children suffering from cancer or hematological disorders. In this paper, the state of Pediatric hematology-oncology in Iran will be presented.

scholarly journals A Survey of the Impact of Patient Adverse Events and near Misses on Anaesthetists in Australia and New Zealand

2018 ◽  
Vol 46 (5) ◽  
pp. 510-515 ◽  
Author(s):  
R. Harrison ◽  
H. Lee ◽  
A. Sharma
Keyword(s):  
Adverse Event ◽  
New Zealand ◽  
Adverse Events ◽  
Incident Reporting ◽  
Near Miss ◽  
Near Misses ◽  
Incident Reporting Systems ◽  
Safety Incident ◽  
Reporting Systems ◽  
The Impact

We conducted a cross-sectional online survey of members of the Australian and New Zealand College of Anaesthetists to investigate their experiences of adverse patient safety events and near misses, including their use of incident reporting systems and the organisational support available. There were 247 respondents. Of the 243 anaesthetists whose patients had an adverse event or near miss, 199 reported this had affected them personally or professionally; 177 reported stress, 153 anxiety, 109 sleep disturbance, and 127 lower professional confidence. Of 188 who had reported an adverse event using their local incident reporting systems, 68 were satisfied with this process, 136 received useful feedback, 114 saw local improvements, and 104 saw system changes. Two hundred and thirty-four reported feeling determined to improve, and 228 were anxious about the potential for future errors. Seventy-five anaesthetists admitted not reporting a safety incident that they knew they should have. Reasons for not reporting included an impression that nothing would improve from incident reporting, that reporting was onerous, or fears of punitive action. These findings should spur anaesthetists, anaesthetic departments and professional organisations across Australia and New Zealand to examine their support mechanisms in relation to adverse events and errors and their incident reporting mechanisms, and to attempt to improve these services where necessary.

scholarly journals Limiting factors to Boolean remission differ between autoantibody-positive and -negative patients in early rheumatoid arthritis

2020 ◽  
Author(s):  
Serena Bugatti ◽  
Ludovico De Stefano ◽  
Francesca Benaglio ◽  
Garifallia Sakellariou ◽  
Antonio Manzo ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Near Miss ◽  
Limiting Factors ◽  
Treat To Target ◽  
Near Misses ◽  
Early Ra ◽  
Full Remission ◽  
Patient Reported ◽  
Autoantibody Status

Abstract Background: Patients with established rheumatoid arthritis (RA) frequently miss Boolean remission solely because of the patient global assessment of disease activity (PGA) exceeding the cut-off of 1. Here, we investigated the frequency and the limiting variables to disease remission in patients with early RA treated with conventional synthetic disease modifying anti-rheumatic drugs according to a treat-to-target strategy, depending on the autoantibody status. Methods: Data were retrieved from 535 early RA patients (<12 months of symptoms), treatment-naïve at inclusion, with an observation period of 6 to 12 months upon initiation of therapy with methotrexate aimed at the achievement of low disease activity based on the 28-joints disease activity score. Near-remission was defined as any of the 4 core items of Boolean remission exceeding the cut-off of 1 with the remaining 3 all ≤1. Reasons for missing Boolean remission and predictors of near-remission subcategories were analysed in relation to baseline disease variables. Results: After 6 and 12 months from treatment start, near-remission was two-times more frequent than Boolean remission (25.6% and 26.9% at the two time-points). A 28-swollen joint count (SJC28) >1 was responsible for the majority of near-misses (56.2% and 57.6% at 6 and 12 months, respectively), and PGA >1 accounted for approximatively 35% of the cases. None of the variables of disease activity neither patient reported outcomes at baseline could discriminate SJC28 from PGA near-misses. Rather, autoantibody-positivity independently predicted the risk of missing remission because of SJC28 >1 with an adjusted OR [95% CI] of 3.62 [1.89-6.93] at 6 months and 2.36 [1.25-4.47] at 12 months, whilst autoantibody-negativity was an independent predictor of PGA near-miss (adjusted OR [95% CI] 2.71 [1.31-5.64] at 6 months and 6.50 [2.47-17.12] at 12 months). Conclusions: In patients with early RA, Boolean remission is more frequently missed because of persistent swollen joints. However, barriers to full-remission vary in relation to the autoantibody status. Autoantibody-positive patients more commonly experience residual swollen joints, whilst the PGA more frequently impairs the achievement of remission in autoantibody-negative patients. These findings indicate that efforts to target full-remission in early RA may require different treatment strategies according to the autoantibody profile.

scholarly journals Online monitoring of patient self-reported adverse events in early phase clinical trials: Views from patients, clinicians, and trial staff

2020 ◽  
pp. 174077452097212
Author(s):  
Fiona Kennedy ◽  
Leanne Shearsmith ◽  
Michael Ayres ◽  
Oana C Lindner ◽  
Lewis Marston ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Early Phase ◽  
Patient Reported Outcome ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
Patient Reported ◽  
Trial Staff ◽  
Early Phase Trial ◽  
Early Phase Clinical Trials

Background/aims New classes of cancer drugs bring a range of unknown and undesirable adverse events. Adverse event monitoring is essential in phase I trials to assess toxicity and safety. In phase II, the focus is also on efficacy but robust data on adverse events continue to inform the safety and the adverse event profile. Standard, clinician-led monitoring has been shown to underestimate patients’ symptoms. Hence, patient-reported adverse event monitoring has been argued to complement and improve the information on adverse events in early phase clinical trials. With advances in information technology, real-time patient self-reported adverse events in trials are feasible. This study explored the experiences and procedures for reporting adverse events in early phase trials among patients, clinical staff, and trial staff, and their views on using an electronic patient-reported outcome adverse event system in this setting. Methods Qualitative interviews were conducted with patients, purposively sampled across ages, gender, and different phases of trials, and with clinical and trial-related staff involved in early phase trials (e.g. consultants, research nurses, hospital-based trial assistants/data managers, trial unit management staff). Interviews explored patient experiences and views on current adverse event reporting processes and electronic patient-reported outcome adverse event reporting. Framework analysis techniques were used to analyse the data. Results Interviewees were from two hospital trusts with early phase portfolios in England and a trial unit, and included sixteen patients, five consultants, four research nurses, five hospital-based trial staff, and two trial unit staff. Interviews identified three key themes (patient experiences, data flow, and views on electronic patient-reported outcome adverse event reporting). Stakeholders emphasised the intensity of trials for patients and the importance of extensive information provision within the uncertainty of early phase trial drugs. Regular face-to-face appointments for patients supplemented by telephone contact aimed to capture any adverse events. Delayed or under-reporting of mild- or low-severity symptoms was evident among patients. Hospital-based staff highlighted the challenges of current data collection including intense timescales, monitoring by trial sponsors, and high workload. Positive views on electronic patient-reported outcome adverse events highlighted that this could provide a more comprehensive and accurate view on the side effects of new drugs. Clinical staff emphasised patient safety and the need for clear responsibilities for monitoring. The need for careful decision-making about data flow and symptom attribution was highlighted; with trial unit staff emphasising the need for clinician review. Conclusion Technology advances mean it is timely to explore the benefits and challenges of electronic patient-reported outcome adverse event reporting. This is a complex area warranting further consideration within the trial community. We have developed an online patient self-reporting tool and a small pilot with early phase trial patients is underway.

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