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BACKGROUND: Objective was to evaluate and refine a new instrument for paediatric cancer symptom screening named the Symptom Screening in Pediatrics Tool (SSPedi). METHODS: Respondents were children 8-18 years of age undergoing active cancer treatment and p

Background: There is no consensus on whether therapeutic intensity can be reduced safely in children with low-risk febrile neutropenia (FN). Our primary objective was to determine whether there is a difference in efficacy between outpatient and inpatient management of children with low-risk FN. Our secondary objective was to compare oral and parenteral antibiotic therapy in this population.Methods: We performed electronic searches of Ovid Medline, EMBASE, and the Cochrane Central Register of Controlled Trials, and limited studies to prospective pediatric trials in low-risk FN. Percentages were used as the effect measure.Results: From 7,281 reviewed articles, 16 were included in the meta-analysis. Treatment failure, including antibiotic modification, was less likely to occur in the outpatient setting compared with the inpatient setting (15 % versus 28 %, P = 0.04) but was not significantly different between oral and parenteral antibiotic regimens (20 % versus 22 %, P = 0.68). Of the 953 episodes treated in the outpatient setting and 676 episodes treated with oral antibiotics, none were associated with infection-related mortality.Conclusion: Based on the combination of results from all prospective studies to date, outpatient and oral antibiotic management of low-risk FN are effective in children and should be incorporated into clinical care where feasible. [ABSTRACT FROM AUTHOR]

Purpose: The utility of peripheral blood cultures in febrile neutropenic children with cancer and central venous catheters (CVC) is controversial. Our primary objective was to describe true bloodstream infections detected only by peripheral culture. Our secondary objectives were to describe true bloodstream infections detected only by CVC culture and to describe probable contaminants detected in both types of blood cultures.Methods: We included children with cancer who had peripheral and CVC cultures obtained on the same day in which at least one culture was positive. Only cultures obtained prior to the initiation of broad-spectrum antibiotics were included. We defined true bloodstream infections due to common contaminants (such as coagulase-negative Staphylococcus) as occurring if multiple cultures were positive for the same organism or if sepsis was present.Results: Between January 2002 and July 2007, 318 episodes of bloodstream infection from 224 children were included. Of these, 228/318 (71.7%) were classified as true bloodstream infections while 90/318 (28.3%) were classified as contaminants. Importantly, 28/228 (12.3%) true bloodstream infections were detected only in peripheral culture while 85/228 (37.3%) true bloodstream infections were detected only by CVC cultures. Contaminants were identified in peripheral culture in 45/318 (14.2%) of episodes and in CVC culture in 45/318 (14.2%) episodes.Conclusions: True bloodstream infections frequently are only detected in the peripheral culture. These data support continuation of the practice of routine peripheral cultures in addition to CVC cultures at the onset of fever for children with cancer who are not already receiving broad-spectrum antibiotics. [ABSTRACT FROM AUTHOR]

Goals Of Work: We aimed to develop an instrument to assess cancer-treatment-related adverse effects that parents believe children find most bothersome and use it to solicit the opinions of parents regarding this issue.Materials and Methods: Parents of children 4 to 18 years of age who had received intravenous antineoplastic therapy in the last month were asked to rank prevalence, severity, and degree of bother of each symptom on behalf of their child using a questionnaire.Main Results: One hundred fifty-eight of 200 (82%) questionnaires were evaluable. The most prevalent symptoms identified were mood swings (85%), fatigue (80%), and disappointment at missing activities with friends/peers (74%). These symptoms were also most commonly identified as being significantly severe. Symptoms most commonly identified as the most bothersome were disappointment at missing activities with friends/peers (50%) and feeling worried about receiving treatment, procedures, or side effects (43%). Symptoms most commonly identified as the most severe and bothersome were disappointment at missing activities with friend/peers (46%); feeling worried about receiving treatment, procedures, or side effects (40%); and painful, aching, or stiff bones, joints, or muscles (36%).Conclusions: This information can be used when explaining the effects of cancer treatment to patients/families, creating policies regarding pediatric cancer care and framing research hypotheses in pediatric supportive care. [ABSTRACT FROM AUTHOR]

Goals Of Work: Aprepitant is currently recommended for the prevention of acute antineoplastic-induced nausea and vomiting in adults receiving highly emetogenic therapy. The lack of an oral liquid dosage form is one barrier to its use in children. The purpose of this study was to develop a stable oral liquid formulation of aprepitant using the marketed aprepitant capsules.Materials and Methods: Aprepitant 20-mg/mL oral liquid was prepared from 125-mg capsule contents in Orablend(R). Twelve test samples were prepared: six packaged in amber glass and six in polyethylene terephthalate (PET) containers, three of each stored at either 23 degrees C or 4 degrees C. The physical characteristics of the oral aprepitant liquid stored in amber glass bottles were evaluated at the time of compounding and on days 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77, 84, and 91. The aprepitant content of three test solutions of each container type and storage temperature was determined using a stability-indicating assay at 5, 9, 14, 29, 48, 62, 73, and 111 days after compounding.Main Results: All samples stored in glass demonstrated suitable physical characteristics and those stored in either glass or PET retained more than 94.0% of the initial concentration. Based on the higher limit of the 95% confidence interval of the degradation rate, suspensions stored at 23 degrees C achieved 10% loss within 66 to 85 days, compared to greater than 100 days when stored at 4 degrees C.Conclusions: The extemporaneous aprepitant oral suspension formulation described is physically and chemically stable for at least 90 days when refrigerated. The bioavailability of this formulation is unknown. [ABSTRACT FROM AUTHOR]

Background: This study aimed to determine the proportion of patients receiving clinical practice guideline (CPG)-inconsistent care related to chemotherapy-induced vomiting (CIV) prophylaxis, and to describe the association between CPG-inconsistent care and site size. The association between delivery of CPG-inconsistent care and patient outcomes (CIV control, admission prolongation, and unplanned healthcare visits) was also described., Methods: This was a retrospective study conducted at Children's Oncology Group (COG) National Cancer Institute Community Oncology Research Program (NCORP) sites. Eligible patients received highly (HEC) or moderately emetogenic chemotherapy (MEC) as inpatients from January 2014 through December 2015, and were previously enrolled in a COG study. The COG generated a patient list from which patients were randomly selected for chart review by participating sites. A central panel adjudicated CIV prophylaxis received as CPG-consistent or -inconsistent., Results: Twenty-four sites participated. Over half of patients received CPG-inconsistent CIV prophylaxis (HEC: 59/112, 52.6%; MEC: 119/215, 55.3%). The most common reasons for CPG-inconsistency were shortened duration of antiemetic administration or omission of dexamethasone. Site size was not found to be associated with CPG-inconsistent care delivery (HEC: adjusted odds ratio [OR]: 0.96, 95% confidence interval [CI]: 0.76-1.23; MEC: adjusted OR: 1.07; 95% CI: 0.92-1.24). Additionally, there was no statistically significant association between receipt of CPG-inconsistent care and patient outcomes., Conclusions: Patients receiving MEC or HEC often received CPG-inconsistent CIV prophylaxis. Site size was not associated with receipt of CPG-inconsistent care. Future studies should evaluate strategies to improve CIV control among pediatric oncology patients including those aimed at improving CPG adherence., (© 2024 The Author(s). Pediatric Blood & Cancer published by Wiley Periodicals LLC.)

Background: Supportive care clinical practice guidelines (CPGs) facilitate the incorporation of the best available evidence into pediatric cancer care. We aimed to assess the impact of the work of the Children's Oncology Group (COG) Supportive Care Guideline Task Force on institutional supportive care practices., Procedure: An online survey was distributed to representatives at 209 COG sites to assess the awareness, use, and helpfulness of COG-endorsed supportive care CPGs. Availability of institutional policies regarding 13 topics addressed by current COG-endorsed CPGs was also assessed. Respondents described their institutional processes for developing supportive care policies., Results: Representatives from 92 COG sites responded to the survey, and 78% (72/92) were "very aware" of the COG-endorsed supportive care CPGs. On average, sites had policies that addressed seven COG-endorsed supportive care CPG topics (median = 7, range: 0-12). Only 45% (41/92) of sites reported having institutional processes for developing supportive care policies. Of these, most (76%, 31/41) reported that the COG-endorsed CPGs have a medium or large impact on policy development. Compared with sites without processes for supportive care policy development, sites with established processes had policies on a greater number of topics aligned with current COG-endorsed CPG topics (mean = 6.6, range: 0-12 vs mean = 7.9, range: 2-12; p = 0.027)., Conclusions: Most site respondents were aware of the COG-endorsed supportive care CPGs. Less than half of the COG sites represented in the survey have processes in place to implement supportive care policies. Improvement in local implementation is required to ensure that patients at COG sites receive evidence-based supportive care., (© 2024 Wiley Periodicals LLC.)

Background: The primary objective was to measure adherence to clinical practice guideline (CPG) recommendations for fertility preservation (FP) in pediatric cancer patients treated in National Cancer Institute Community Oncology Research Program (NCORP) sites. Secondary objectives were to describe factors such as site size associated with CPG-inconsistent care delivery and cryopreservation completion. Methods: This retrospective, multicenter study included patients 15 to 21 years old with a first cancer diagnosis from January 2014 through December 2015 who were previously enrolled to a Children's Oncology Group (COG) study and received care at a participating NCORP site. Patients were randomly selected from a list generated by the COG for chart review by participating sites. Primary outcome was care delivery that was inconsistent with a strong CPG recommendation on FP, namely discussion and offering of FP options before cancer treatment initiation, as adjudicated centrally by a panel. Results: A total of 129 patients from 25 sites were included. Among these, 48% (62/129) received CPG-inconsistent care. Most CPG-inconsistent care was due to lack of FP discussion documentation (93.5%, 58/62). Small site size, treatment at a pediatric (vs mixed adult/pediatric) site, and female sex were associated with higher odds of CPG-inconsistent care delivery. Conclusions: Newly diagnosed pediatric cancer patients often received CPG-inconsistent care for FP, with disproportionate gaps noted for females, and those treated at smaller or pediatric NCORP sites. The primary reason for CPG-inconsistent care is lack of FP discussion from clinicians. Opportunities to improve FP CPG implementation are highlighted.

Due to an evidence gap, the emetogenicity of intravenous (IV) pegaspargase was unable to be included in the clinical practice guideline classifying chemotherapy emetogenicity in pediatric patients. This single-center, retrospective chart review describes the proportion of pediatric patients who did not vomit during the acute phase (complete response; CR) after receiving IV pegaspargase and provides an emetogenicity classification using a preexisting framework. Of 44 patients who received IV pegaspargase between 2011 and 2020, 13 received a serotonin receptor antagonist plus dexamethasone or palonosetron alone and all experienced a CR. We, therefore, recommend classifying IV pegaspargase as moderately emetogenic.

Dexamethasone use during hematopoietic cell transplant (HCT) conditioning varies between pediatric centers. This study aimed to estimate the difference in 1-year treatment-related mortality (TRM) between patients who did or did not receive dexamethasone during HCT conditioning. Secondary objectives were to estimate the difference between dexamethasone-exposed and dexamethasone-unexposed groups in 1-year event-free survival (EFS), time to neutrophil engraftment, acute graft-versus-host disease (aGVHD), and invasive fungal disease (IFD) at day + 100. This was a seven-site, international, retrospective cohort study. Patients < 18 years old undergoing their first allogeneic or autologous myeloablative HCT for hematologic malignancy or aplastic anemia between January 1, 2012, and July 31, 2017, were included. To control for potential confounders, propensity score weighting was used to calculate the standardized mean difference for all endpoints. Among 242 patients, 140 received dexamethasone during HCT conditioning and 102 did not. TRM was unaffected by dexamethasone exposure (1.7%; 95% CI - 7.4, 10.2%). Between-group differences in secondary outcomes were small. However, dexamethasone exposure significantly increased possible, probable, and proven IFD incidence (9.0%, 95% CI 0.8, 17.3%). TRM is not increased in pediatric patients who receive dexamethasone during HCT conditioning. Clinicians should consider potential IFD risk when selecting chemotherapy-induced vomiting prophylaxis for pediatric HCT patients., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: This study describes chemotherapy-induced nausea and vomiting (CINV) control rates in pediatric and adult patients who did or did not receive guideline-consistent CINV prophylaxis., Methods: We conducted a systematic literature review of studies published in 2000 or later that evaluated CINV control in patients receiving guideline-consistent vs. guideline-inconsistent CINV prophylaxis and reported at least one CINV-related patient outcome. Studies were excluded if the guideline evaluated was not publicly available or not developed by a professional organization. Over-prophylaxis was defined as antiemetic use recommended for a higher level of chemotherapy emetogenicity than a patient was receiving., Results: We identified 7060 citations and retrieved 141 publications for full-text evaluation. Of these, 21 publications (14 prospective and seven retrospective studies) evaluating guidelines developed by six organizations were included. The terms used to describe CINV endpoints and definition of guideline-consistent CINV prophylaxis varied among studies. Included studies either did not address over-prophylaxis in their definition of guideline-consistent CINV prophylaxis (48%; 10/21) or defined it as guideline-inconsistent (38%; 8/21) or guideline-consistent (3/21; 14%). Eleven included studies (52%; 11/21) reported a clinically meaningful improvement in at least one CINV endpoint in patients receiving guideline-consistent CINV prophylaxis. Ten reported a statistically significant improvement., Conclusions: This evidence supports the use of guideline-consistent prophylaxis to optimize CINV control. Institutions caring for patients with cancer should systematically adapt CINV CPGs for local implementation and routinely evaluate CINV outcomes., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: The Pediatric Oncology Group of Ontario (POGO) supported an effort to implement infection management care pathways based on clinical practice guidelines, to improve the consistency of infection management in pediatric cancer patients. The objective of this qualitative study was to describe the perspective of healthcare professionals (HCPs) following implementation., Methods: Four tertiary pediatric oncology centers in Ontario, Canada, implemented the pathways. We randomly identified three HCPs per group (clinical pharmacists; nurse case managers, educators or practitioners and physician assistants; pediatric oncology fellows; or pediatric oncology staff physicians) per site and invited them to participate in a qualitative interview. One-on-one interviews were conducted remotely, followed by thematic analysis of interview transcripts., Results: A total of 66 invitations were extended and 42 HCPs participated. Identified themes were: (1) implementation approach, (2) access and navigation, (3) engagement, (4) concerns, (5) workplace benefits, (6) reception, and (7) provincial harmonization. HCPs preferred in-person implementation strategies over e-mail communication. They identified teaching/educational utility and benefits to non-oncology departments and non-tertiary centers participating in shared care of patients. Other positive aspects related to evidence-based practice, safety, supporting oncology HCPs, and benefits to patients and families. Concerns included need to ensure users applied clinical judgement and loss of autonomy. Provincial harmonization of practice was viewed positively, although potential logistical and institutional cultural barriers were raised., Conclusions: Following infection management care pathway implementation, HCPs described educational utility and benefits to non-oncology departments, oncology HCPs, patients, and families. Our findings may facilitate future infection management care pathway provincial harmonization., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Primary objective was to determine if a patient informational brochure describing potentially useful strategies could help manage specific taste changes. Secondary objective was to describe the specific strategies used and whether the strategies were perceived as being helpful., Procedure: This single-center study included pediatric patients with cancer or hematopoietic cell transplant recipients receiving active treatment who experienced bothersome taste changes in the last month. Participants participated in baseline and follow-up interviews conducted 14-21 days apart. A brochure that listed 16 potentially helpful strategies was provided at baseline. At follow-up, we asked about brochure use and whether it helped. At both interviews, we asked about experienced taste changes, strategies used, and whether strategy helped., Results: Of 100 enrolled participants, different (87%) and bad (72%) taste were most common at baseline. Following the brochure intervention, statistically significant reductions were observed in food tasting different, bad, bland, bitter, sour, and metallic. For most strategies, the proportion of patients who used specific strategies or found them helpful was not significantly different between baseline and follow-up. However, "eating foods you like" was considered helpful in significantly more participants who used the strategy in follow-up (72 out of 89, 80.9%) compared with baseline (55 out of 95, 57.9%; p = .008). Between visits, 81.2% looked at the brochure. Among participants, 53.1% found the brochure helpful, very helpful, or extremely helpful., Conclusions: A brochure that offered strategies to manage changes in taste helped participants cope with them. Further research should evaluate the brochure using randomized and multicenter trials., (© 2024 Wiley Periodicals LLC.)

Chemotherapy-induced nausea and vomiting (CINV) are frequent and dreaded side effects in cancer treatments. CINV has a major impact on patient's condition and quality of life. Prophylaxis is tailored to patient's profile and the emetogenic level of their chemotherapy. The aim of this study is to update the recommendations for CINV prevention and management in pediatric onco-hematology for use in France, by adapting the guidelines of the Pediatric Oncology Group of Ontario (POGO). Clinical practice guideline adaptation is a recognized method for tailoring existing clinical practice guidelines to local context. A multidisciplinary French-speaking panel was formed to discuss about POGO guideline recommendations for the acute and delayed phases, breakthrough, refractory and anticipatory CINV and the evidence supporting them. Panel members were asked whether they wanted to adopt, modify or reject each of the POGO guideline recommendations. Panel members translated each recommendation and adapted recommendations for an implementation in France. Their acceptance required agreement at least 80 % of panel members. Algorithms and tables were created, listing all the recommendations and providing a better overview for decision-making process adapted to the patient's profile. These recommendations should be reviewed for implementation at French institutions caring for pediatric cancer patients and once implemented, the rates of adherence to recommendations and CINV control should be reported., (Copyright © 2024 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.)

Our objective was to update a clinical practice guideline for the prevention and treatment of Clostridioides difficile infection (CDI) in pediatric patients with cancer and hematopoietic cell transplantation recipients. We reconvened an international multi-disciplinary panel. A systematic review of randomized controlled trials (RCTs) for the prevention or treatment of CDI in any population was updated and identified 31 new RCTs. Strong recommendations were made to use either oral metronidazole or oral vancomycin for non-severe CDI treatment, and to use either oral vancomycin or oral fidaxomicin for severe CDI. A strong recommendation that fecal microbiota transplantation should not be routinely used to treat CDI was also made. The panel made two new good practice statements to follow infection control practices including isolation in patients experiencing CDI, and to minimize systemic antibacterial administration where feasible, especially in patients who have experienced CDI., Competing Interests: BTF has served on a data safety monitoring board for Astellas and BTF's institution has received grant support from Allovir and Pfizer as well as CDC, FDA and NIH for research performed. CD has received support from Abramson Cancer Center K12 and a CIHR Fellowship Award. TL's institution has received an unrestricted research grant by Gilead Sciences and TL has received payments or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from: Astra Zeneca, EUSA Pharma, Gilead Sciences, MSD/Merck and Pfizer. TL has received support for attending meetings and/or travel from EUSA Pharma and has served on a data safety monitoring board or advisory board for: EUSA Pharma, Gilead Sciences, Merck/MSD, Mundipharma, Pfizer and Pharming. TL has had a leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid at: Working Party Infection German Society of Pediatric Oncology and Hematology and Working Party Infection German Society of Pediatric Infectious Diseases. LS is supported by the Canada Research Chair in Pediatric Oncology Supportive Care. No other authors declared a conflict of interest., (© 2024 The Author(s).)

Background: We validated different approaches to symptom assessment for pediatric cancer patients based on the Symptom Screening in Pediatrics Tool (SSPedi) for self-report (SSPedi and mini-SSPedi), proxy-report (proxy-SSPedi), and structured dyadic-report (co-SSPedi). The objective was to compare co-SSPedi scores vs proxy-report (proxy-SSPedi) and self-report (SSPedi or mini-SSPedi) scores for pediatric patients receiving cancer treatments., Methods: This was a single-center, randomized crossover study enrolling English-speaking dyads of pediatric patients with cancer or hematopoietic cell transplant recipients 4-18 years old and their guardians. Dyads were randomized to first complete the dyadic-report (co-SSPedi) or self-report (patients: SSPedi or mini-SSPedi) and proxy-report (guardians: proxy-SSPedi). Dyads then crossed over to the alternate approach. Primary analysis compared total SSPedi scores between randomized groups., Results: We enrolled 420 dyads that were randomized to co-SSPedi first (n = 213) or proxy-SSPedi and self-report SSPedi first (n = 207). Mean total SSPedi scores (± standard deviation) were co-SSPedi (9.6 ± 7.1), proxy-SSPedi (9.7 ± 7.5; P = .950 for comparison vs co-SSPedi), and self-report SSPedi (9.7 ± 8.2; P = .981 for comparison vs co-SSPedi). Co-SSPedi scores were significantly different from proxy-SSPedi for feeling disappointed or sad, feeling cranky or angry, feeling tired, mouth sores, and changes in taste. Co-SSPedi scores were significantly different from self-report SSPedi scores for problems with thinking or remembering things, feeling tired, mouth sores, tingly or numb hands or feet, and diarrhea., Conclusions: Total co-SSPedi scores were not significantly different compared with proxy-report or self-report scores, although there were differences in specific symptom scores. If different reporter types are used during clinical implementation, specifying reporter type will be important. The study was registered at clinicaltrials.gov (NCT #05012917). Symptoms are common and frequently severely bothersome in pediatric patients with cancer and hematopoietic cell transplant (HCT) recipients (1). To measure the extent of bothersome symptoms, the Symptom Screening in Pediatrics Tool (SSPedi) suite of symptom assessment tools was developed for pediatric patients receiving cancer treatments and currently consists of multiple validated instruments. SSPedi was developed for self-report by patients 8-18 years of age (2,3). Mini-SSPedi was developed for self-report by patients 4 to 7 years of age (4). Proxy-SSPedi was developed for proxy-report by guardians of pediatric patients 2-18 years of age (5). These 3 instruments can be categorized as either self-report (SSPedi or mini-SSPedi) or proxy-report (proxy-SSPedi)., (© The Author(s) 2023. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: The primary objective was to measure the proportion of episodes where care delivery was inconsistent with selected recommendations of a clinical practice guideline (CPG) on fever and neutropenia (FN) management. The influence of site size on CPG-inconsistent care delivery, and association between patient outcomes and CPG-inconsistent care were described., Methods: This retrospective, multicenter study included patients less than 21 years old with cancer who were at high risk of poor FN outcomes and were previously enrolled to a Children's Oncology Group (COG) study at participating National Cancer Institute Community Oncology Research Program (NCORP) institutions from January 2014 through December 2015. Patients were randomly selected for chart review by participating sites from a COG-generated list. Care delivered in each episode was adjudicated (CPG-consistent or CPG-inconsistent) against each of five selected recommendations., Results: A total of 107 patients from 22 sites, representing 157 FN episodes, were included. The most common CPG-inconsistent care delivered was omission of pulmonary computerized tomography in patients with persistent FN (60.3%). Of 74 episodes where assessment of four (episodes without persistent FN) or five (episodes with persistent FN) recommendations was possible, CPG-inconsistent care was delivered with respect to at least one recommendation in 63 (85%) episodes. Site size was not associated with CPG-inconsistent care delivery. No statistically significant association between CPG-inconsistent care and fever recurrence was observed., Conclusions: In this cohort of pediatric patients at high risk of poor FN outcomes, CPG-inconsistent care was common. Opportunities to optimize resource stewardship by boosting supportive care CPG implementation are highlighted., (© 2024 The Authors. Pediatric Blood & Cancer published by Wiley Periodicals LLC.)

Introduction: Clinical practice guidelines (CPGs) recommending palonosetron for the prevention and management of chemotherapy-induced nausea and vomiting (CINV) were adapted for use at our institution. Palonosetron was restricted for use in patients experiencing breakthrough CINV and receiving highly emetogenic chemotherapy (HEC) or undergoing stem cell transplant conditioning and in patients with refractory CINV receiving HEC. Given the significant cost of palonosetron, we aimed to determine the proportion of chemotherapy blocks where palonosetron use was discordant with the institutional policy or source CPG., Methods: A retrospective review of the health records of patients who received palonosetron between 1 July 2019 and 30 June 2020 was undertaken. Details of palonosetron use, antiemetic regimen and the date and time of each vomit during the acute and delayed phases were collected for each chemotherapy block where palonosetron was given. Discordance with the institutional policy and the source CPG was determined by assessing the indication for palonosetron and the dose. In the subset of chemotherapy blocks where information regarding vomiting episodes was available, the extent of acute phase chemotherapy-induced vomiting (CIV) control was reported., Results: Four hundred thirty-eight chemotherapy blocks, representing 122 patients (mean age 9 years), receiving 595 palonosetron doses were included. Palonosetron use was discordant with institutional policy during most (72%; 314/438) of the chemotherapy blocks analyzed. However, palonosetron use was concordant with the source CPG during most chemotherapy blocks (74%; 326/438). Complete CIV control during the acute phase was observed in 66% (195/295) of chemotherapy blocks where palonosetron was given, irrespective of concomitant antiemetics administered., Conclusion: The majority of palonosetron use at our institution was discordant with institutional policy, but concordant with the source CPG. Our institutional policy has since been updated to be more aligned with the source CPG., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objectives: To translate the Pediatric Nausea Assessment Tool (PeNAT) into Hindi and validate it in Indian pediatric cancer patients and survivors., Methods: The PeNAT-Hindi was finalized by forward and backward translations, and pilot testing. The PeNAT-Hindi was administered to 200 Hindi-speaking pediatric (4-18 y) cancer patients/survivors, in three groups. These included pediatric cancer patients who had recently received chemotherapy (n = 150); who received no chemotherapy within 5 d (n = 25) and survivors (n = 25). Construct validity was tested by comparing scores among the three groups. Test-retest reliability and criterion validity were estimated by the correlation of the first PeNAT score with the second (taken 1 h later) PeNAT score and the number of vomiting/retching episodes, respectively. Convergent validity and discriminant validity were estimated by correlating PeNAT scores with parent-assessed nausea severity, and pain, respectively. The responsiveness was tested by comparing second PeNAT scores with subsequent divergent PeNAT scores among patients reporting subjective change (improvement and worsening, respectively) in nausea severity., Results: Test-retest reliability of PeNAT-Hindi was good (intraclass correlation = 0.791). The initial PeNAT score had moderate correlation with the number of vomiting/retching episodes (Spearman ρ = 0.401). Median PeNAT scores in group 1 versus groups 2 and 3 were significantly different (p < 0.001). Initial PeNAT scores showed a moderate correlation with parent-assessed nausea (Spearman ρ = 0.657) and a weak correlation with parent-assessed pain (Spearman ρ = 0.319). The responsiveness (standardized response mean) of PeNAT-Hindi to the change in nausea severity was -1.79 (improvement) and 2.19 (worsening), respectively., Conclusion: PeNAT-Hindi showed good reliability and acceptable validity. It may be used among Hindi-speaking children for measuring nausea. The responsiveness of PeNAT-Hindi needs further evaluation., (© 2023. The Author(s), under exclusive licence to Dr. K C Chaudhuri Foundation.)

Background: Co-Symptom Screening in Pediatrics Tool (co-SSPedi) is a dyadic (child-guardian) approach to symptom assessment. Objectives were to evaluate the reliability and validity of co-SSPedi for pediatric patients receiving cancer treatments., Methods: This multicenter study included dyads of patients aged 4-18 years of age with cancer or undergoing hematopoietic cell transplant and their guardians. Two groups were enrolled. The more symptomatic group included those receiving active treatment for cancer or undergoing hematopoietic cell transplant where patients were in hospital or clinic for 4 consecutive days. The less symptomatic group included those receiving maintenance therapy for acute lymphoblastic leukemia or who had completed cancer treatments. At baseline, all dyads completed co-SSPedi, and guardians completed measures of mucositis, nausea, pain, quality of life, and overall symptoms. In the more symptomatic group, dyads completed co-SSPedi and a global symptom change scale on day 4., Results: There were 501 dyads included: 301 in the more symptomatic group and 200 in the less symptomatic group. Median time to complete co-SSPedi was less than 3 minutes in both groups. Test-retest reliability intraclass correlation coefficient was 0.85 (95% confidence interval [CI] = 0.77 to 0.90). For internal consistency, total co-SSPedi Cronbach alpha was 0.81 (95% CI = 0.78 to 0.83). For known groups validation, mean difference in total co-SSPedi scores between the more symptomatic and less symptomatic groups was 7.8 (95% CI = 6.7 to 8.8; P < .0001). For convergent validation and responsiveness, all hypothesized relationships were demonstrated., Conclusions: Co-SSPedi is a novel approach to dyadic symptom assessment that is reliable, valid, and responsive in pediatric patients aged 4-18 years., (© The Author(s) 2023. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objectives: Primary objectives were to determine the relationship between prevalence of symptom documentation and intervention provision, and increasing severity of bothersome symptoms, as identified by guardians using guardian-reported Symptom Screening in Pediatrics Tool (proxy-SSPedi), which is validated and measures the extent of bothersome symptoms in paediatric patients with cancer., Methods: We included guardians of children 2-7 years of age receiving cancer treatments and seen in hospital daily for 4 consecutive days. Guardians reported proxy-SSPedi at study enrolment and 3 days later. Chart review was performed between the day prior and the day following proxy-SSPedi completion. Symptom documentation and intervention provision were determined by two independent abstractors., Results: We enrolled 190 guardians who provided 371 proxy-SSPedi assessments in 190 children. The most common severely bothersome symptoms were 'feeling tired', 'feeling more or less hungry than they usually do' and 'feeling cranky or angry'. Among those with increasing severity of bother, documentation was significantly more common for 12 symptoms while intervention was significantly more common for 7 symptoms. Intervention was not significantly more common with increasing severity of bother due to 'feeling tired', 'feeling more or less hungry than they usually do' and 'feeling cranky or angry'., Conclusions: Symptom documentation was generally more common in patients with severely bothersome symptoms. Intervention was not more common among those with increasing severity of bother due to fatigue, changes in hunger or anger, which were the most common severely bothersome symptoms. Future efforts should focus on facilitating intervention provision to patients with bothersome symptoms., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Taste changes are common among paediatric patients receiving cancer treatments although specific descriptions and associations are uncertain. Primary objective was to describe the number of paediatric patients receiving cancer therapies who experienced taste changes, its impact on food intake and enjoyment of eating, and coping strategies., Methods: This was a cross-sectional study that included English-speaking paediatric patients aged 4-18 years with a diagnosis of cancer or haematopoietic stem cell transplantation recipients receiving active treatment. Using a structured interview, we asked participants about their experience with taste changes, impacts and coping strategies. The respondent was the paediatric patient., Results: We enrolled 108 patients; median age was 11 years (IQR 8-15). The taste changes reported yesterday or today were food tasting bland (34%), bad (31%), different (27%), bitter (25%), extreme (19%), metallic (15%) or sour (12%). Taste changes were associated with decreased food intake (31%) and decreased enjoyment in eating (25%) yesterday or today. The most common coping strategies were eating food they liked (42%), eating strong-tasting food (39%), drinking liquids (35%), brushing teeth (31%) and sucking on candy (25%). Factors significantly associated with food tasting bad were as follows: older age (p=0.003), shorter time since cancer diagnosis (p=0.027), nausea and vomiting (p=0.008) and mucositis (p=0.009)., Conclusions: Among paediatric patients receiving cancer treatments, taste changes were common and were associated with decreased food intake and enjoyment in eating. Common coping strategies were described. Reducing nausea, vomiting and mucositis may improve taste changes., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Symptom Screening in Pediatrics Tool (SSPedi) is a validated self-report symptom screening tool for patients with cancer 8-18 years of age. Co-SSPedi is a novel dyad approach in which both child and parent complete SSPedi together. The objective was to finalise the approach to co-SSPedi administration with instruction that is easy to understand, resulting in dyads completing co-SSPedi correctly., Method: We enrolled child and parent dyads, who understood English and where children (4-18 years) had cancer or were hematopoietic stem cell transplantation recipients. We provided each dyad with instruction on how to complete co-SSPedi together. Mixed methods were used to determine how easy or hard the instruction was to understand. Two raters adjudicated if co-SSPedi was completed correctly. Dyads were enrolled in cohorts of 12 evenly divided by age (4-7, 8-10, 11-14 and 15-18 years)., Results: We enrolled 5 cohorts of 12 dyads, resulting in 60 dyads. Following verbal instruction provided in the first cohort, we identified the need for written instruction emphasising children should wait for parent response prior to entering scores. The instruction was iteratively refined based on qualitative feedback until the fifth cohort, where all 12 dyads found the instruction easy to understand and completed co-SSPedi correctly., Conclusions: We developed a standard approach to dyad symptom screening named co-SSPedi with instruction that is easy to understand, resulting in correct co-SSPedi completion. Future efforts should focus on co-SSPedi validation and understanding how co-SSPedi scores compare to self- or proxy-reported symptom reporting., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Changes in taste is a common symptom in paediatric patients receiving cancer therapies. The primary objective was to describe the prevalence of taste changes longitudinally over a 6-month time frame among paediatric patients with newly diagnosed cancer. Secondary objective was to identify factors associated with taste changes over time., Methods: In this longitudinal, single centre study, we included paediatric patients newly diagnosed with cancer within the previous 8 weeks who were 4-18 years of age. Interviews were conducted once monthly for 6 months. We asked participants about their experience with taste changes, whether potential interventions were successful and whether taste changes influenced eating. Risk factors were evaluated using generalised linear mixed-effects models., Results: Overall, 60 participants were included. At baseline, 23 (38.3%) participants reported experiencing changes in taste, with the proportion significantly declining over time to 13 (21.7%) at 6 months. The most common specific taste changes were food tasting different, bad or bland. The most common helpful strategies were eating liked foods only, brushing teeth or using mouthwash, drinking more liquids and eating food with strong flavour. Taste change was commonly associated with eating less than usual and reduced enjoyment in eating. Nausea, dry mouth and recent vincristine were independent risk factors for taste changes., Conclusions: Changes in taste were common within 8 weeks of cancer diagnosis and declined significantly over time. Nausea, dry mouth and recent vincristine were independent risk factors. Future studies should develop and evaluate interventions for managing taste changes in paediatric patients with cancer., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

The optimization of outcomes for pediatric cancer patients relies on the successful advancement of supportive care to ease the treatment burden and mitigate the long-term impacts of cancer therapy. Advancing pediatric supportive care requires research prioritization as well as the development and implementation of innovations. Like the prevailing theme throughout pediatric oncology, there is a clear need for personalized or precision approaches that are consistent, evidence-based, and guided by clinical practice guidelines. By incorporating technology and datasets, we can address questions which may not be feasible to explore in clinical trials. Now is the time to listen to patients' voices by using patient-reported outcomes (PROs) to ensure that their contributions and experiences inform clinical care plans. Furthermore, while the extrapolation of knowledge and approaches from adult populations may suffice in the absence of pediatric-specific evidence, there is a critical need to specifically understand and implement elements of general and developmental pediatrics like growth, nutrition, development, and physical activity into care. Increased research funding for pediatric supportive care is critical to address resource availability, equity, and disparities across the globe. Our patients deserve to enjoy healthy, productive lives with optimized and enriched supportive care that spans the spectrum from diagnosis to survivorship.

Objective: Childhood and adolescent cancer can result in high burden of distressing symptoms, particularly in high-risk malignancies. The Symptom Screening in Pediatrics Tool (SSPedi) is a reliable and valid approach to measure bothersome symptoms in paediatric patients receiving cancer treatments. Objective was to describe the feasibility of using SSPedi administration among paediatric patients with high-risk malignancies., Methods: We conducted a single-centre, cross-sectional study of patients aged 8-18 years with high-risk malignancies in a French paediatric oncology unit. Patients self-reported the degree of bothersome symptoms using SSPedi and difficulty with SSPedi completion. The total SSPedi Score ranging from 0 to 60 (where 60 is worst) and most common moderately bothersome symptoms (scored ≥2 on 0-4 Likert Scale) were described. Feasibility was defined as more than 75% of patients agreeing to participate and more than 90% completion of SSPedi questionnaire., Results: Out of 16 patients approached, 1 declined participation. Median age was 13 years (IQR 8-19). All were able to self-report SSPedi without difficulty. Patients experienced a median number of 6 (range 0-15) bothersome symptoms (score >0). The mean total SSPedi Score was 12 (SD=9.4). Most common moderately bothersome symptoms were pain (8/15), changes in hunger (8/15) and feeling tired (7/15)., Conclusion: Patient-reported symptom assessment among children and adolescents with high-risk malignancies is feasible using SSPedi. These patients experience a high burden of bothersome symptoms., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Children's Oncology Group (COG) pharmacists and pharmacy technicians from more than 200 COG-member institutions comprise the COG Pharmacy Discipline. Discipline members serve an essential role in the design and execution of COG clinical trials. Core activities include study drug management, study drug access, clinical trial operations, protocol harmonization, and direct patient care. Discipline members are also actively involved in continuing education, membership engagement, and research across other COG committees/domains. Future areas of committed growth for the discipline include pharmacogenomics, pharmacokinetics, pharmacoeconomics, pharmaceutics, and implementation science., (© 2023 Wiley Periodicals LLC.)

The objective of the Cancer Control and Supportive Care (CCL) Committee in the Children's Oncology Group (COG) is to reduce the overall morbidity and mortality of therapy-related toxicities in children, adolescents, and young adults with cancer. We have targeted five major domains that cause clinically important toxicity: (i) infections and inflammation; (ii) malnutrition and metabolic dysfunction; (iii) chemotherapy-induced nausea and vomiting; (iv) neuro- and oto-toxicty; and (v) patient-reported outcomes and health-related quality of life. Subcommittees for each domain prioritize randomized controlled trials and biology aims to determine which strategies best mitigate the toxicities. The findings of these trials are impactful, informing clinical practice guidelines (CPGs) and directly leading to changes in the standard of care for oncology practice. With the development of new therapies, there will be new toxicities, and the COG CCL Committee is dedicated to developing interventions to minimize acute and delayed toxicities, lessen morbidity and mortality, and improve quality of life in pediatric and young adult patients with cancer., (© 2023 Wiley Periodicals LLC.)

Objective was to update a clinical practice guideline (CPG) for the management of fatigue in children and adolescents with cancer or pediatric hematopoietic cell transplant recipients. We reconvened a multi-disciplinary and multi-national panel. While the previous 2018 CPG evaluated adult and pediatric randomized controlled trials (RCTs) to manage fatigue, this 2023 update revised previous recommendations based only on pediatric RCTs. Twenty RCTs were included in the updated systematic review. Physical activity significantly reduced fatigue (standardized mean difference -0.44, 95% confidence interval -0.64 to -0.24; n = 8 RCTs). Using the 2018 recommendations as a basis, the panel continued to make strong recommendations to use physical activity, and to offer relaxation, mindfulness or both, to manage fatigue in pediatric patients. Cognitive or cognitive behavioral therapies may be offered. Pharmacological approaches should not be routinely used. The panel made a new good practice statement to routinely assess for fatigue, ideally using a validated scale., Competing Interests: PSH received grants or research support from NIH; royalties or licenses from Lippincott; consulting fees from MSKCC and participated on the REACH Board at Nemours, Delaware. SNCR received grants from CIHR, CCS and Kids Cancer Care-IMPACT. LS is supported by the Canada Research Chair in Pediatric Oncology Supportive Care. No other authors declared a conflict of interest., (© 2023 The Author(s).)

This clinical practice guideline update provides recommendations for treating breakthrough chemotherapy-induced nausea and vomiting (CINV) and preventing refractory CINV in pediatric patients. Two systematic reviews of randomized controlled trials in adult and pediatric patients informed the recommendations. In patients with breakthrough CINV, escalation of antiemetic agents to those recommended for chemotherapy of the next higher level of emetogenic risk is strongly recommended. A similar recommendation to escalate therapy is made to prevent refractory CINV in patients who did not experience complete breakthrough CINV control and are receiving minimally or low emetogenic chemotherapy. A strong recommendation to use antiemetic agents that controlled breakthrough CINV for the prevention of refractory CINV is also made., (© 2023 The Authors. Pediatric Blood & Cancer published by Wiley Periodicals LLC.)

Background: There is substantial heterogeneity in symptom management provided to pediatric patients with cancer. The primary objective was to describe the adaptation process and specific adaptation decisions related to symptom management care pathways based on clinical practice guidelines. The secondary objective evaluated if institutional factors were associated with adaptation decisions., Methods: Fourteen previously developed symptom management care pathway templates were reviewed by an institutional adaptation team composed of two clinicians at each of 10 institutions. They worked through each statement for all care pathway templates sequentially. The institutional adaptation team made the decision to adopt, adapt or reject each statement, resulting in institution-specific symptom management care pathway drafts. Institutional adaption teams distributed the 14 care pathway drafts to their respective teams; their feedback led to care pathway modifications., Results: Initial care pathway adaptation decision making was completed over a median of 4.2 (interquartile range 2.0-5.3) weeks per institution. Across all institutions and among 1350 statements, 551 (40.8%) were adopted, 657 (48.7%) were adapted, 86 (6.4%) were rejected and 56 (4.1%) were no longer applicable because of a previous decision. Most commonly, the reason for rejection was not agreeing with the statement (70/86, 81.4%). Institutional-level factors were not significantly associated with statement rejection., Conclusions: Acceptability of the 14 care pathways was evident by most statements being adopted or adapted. The adaptation process was accomplished over a relatively short timeframe. Future work should focus on evaluation of care pathway compliance and determination of the impact of care pathway-consistent care on patient outcomes., Trial Registration: clinicaltrials.gov, NCT04614662. Registered 04/11/2020, https://clinicaltrials.gov/ct2/show/NCT04614662?term=NCT04614662&draw=2&rank=1 ., (© 2023. The Author(s).)

Purpose: To update a clinical practice guideline (CPG) for the empiric management of fever and neutropenia (FN) in pediatric patients with cancer and hematopoietic cell transplantation recipients., Methods: The International Pediatric Fever and Neutropenia Guideline Panel reconvened to conduct the second update of this CPG. We updated the previous systematic review to identify new randomized controlled trials (RCTs) evaluating any strategy for the management of FN in pediatric patients. Using the Grading of Recommendations Assessment, Development and Evaluation framework, evidence quality was classified as high, moderate, low, or very low. The panel updated recommendations related to initial management, ongoing management, and empiric antifungal therapy. Changes from the 2017 CPG were articulated, and good practice statements were considered., Results: We identified 10 new RCTs in addition to the 69 RCTs identified in previous FN CPGs to inform the 2023 FN CPG. Changes from the 2017 CPG included two conditional recommendations regarding (1) discontinuation of empiric antibacterial therapy in clinically well and afebrile patients with low-risk FN if blood cultures remain negative at 48 hours despite no evidence of marrow recovery and (2) pre-emptive antifungal therapy for invasive fungal disease in high-risk patients not receiving antimold prophylaxis. The panel created a good practice statement to initiate FN CPG-consistent empiric antibacterial therapy as soon as possible in clinically unstable febrile patients., Conclusion: The updated FN CPG incorporates important modifications on the basis of recently published trials. Future work should focus on addressing knowledge gaps, improving CPG implementation, and measuring the impact of CPG-consistent care.

Objective: To develop a summary format of clinical practice guideline (CPG) recommendations to improve understandability among health care professionals., Methods: We developed a summary format based on current research and used the "Think Aloud" technique in one-on-one cognitive interviews to iteratively improve it. Interviews of health care professionals from Children's Oncology Group-member, National Cancer Institute Community Oncology Research Program sites were conducted. After every five interviews (a round), responses were reviewed, and changes made to the format until it was well understood and no new, substantive suggestions for revision were raised. We took a directed (deductive) approach to content analysis of the interview notes to identify concerns related to recommendation summary usability, understandability, validity, applicability and visual appeal., Results: During seven rounds of interviews with 33 health care professionals, we identified important factors that influenced understandability. Participants found understanding weak recommendations more challenging than strong recommendations. Understanding was improved when the term 'conditional' recommendation was used instead of 'weak' recommendation. Participants found a Rationale section to be very helpful but desired more information when a recommendation entailed a practice change. In the final format, the recommendation strength is clearly indicated in the title, highlighted, and defined within a text box. The rationale for the recommendation is in a column on the left, with supporting evidence on the right. In a bulleted list, the Rationale section describes the benefits and harms and additional factors, such as implementation, that were considered by the CPG developers. Each bullet under the supporting evidence section indicates the level of evidence with an explanation and the supporting studies with hyperlinks when applicable., Conclusions: A summary format to present strong and conditional recommendations was created through an iterative interview process. The format is straightforward, making it easy for organizations and CPG developers to use it to communicate recommendations clearly to intended users., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Santesso et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: Primary objective was to determine the feasibility of three times weekly symptom reporting by pediatric cancer patients for eight weeks., Methods: We included English-speaking patients 8-18 years of age with cancer. Patients were sent reminders by text or email to complete Symptom Screening in Pediatrics Tool (SSPedi) three times weekly for eight weeks. When patients reported at least one severely bothersome symptom, the symptom report was emailed to the primary healthcare team. Patient-reported outcomes were obtained at baseline, week 4 ± 1 and week 8 ± 1. Symptom documentation, intervention provision for symptoms and unplanned healthcare encounters were determined by chart review at weeks 4 and 8. The primary endpoint was feasibility, defined as at least 75% patients achieving adherence with at least 60% of SSPedi evaluations. We planned to enroll successive cohorts until this threshold was met., Results: Two cohorts consisting of 30 patients (cohort 1 (n = 20) and cohort 2 (n = 10)) were required to meet the feasibility threshold. In cohort 1, 11/20 (55%) met the SSPedi completion threshold. Interventions applied after cohort 1 included engaging parents to facilitate pediatric patient self-report, offering mechanisms to remember username and password and highlighting potential benefits of symptom feedback to clinicians. In cohort 2, 9/10 (90%) met the SSPedi completion threshold and thus feasibility was met. Patient-reported outcomes and chart review outcomes were obtained for all participants in cohort 2., Conclusions: Three times weekly symptom reporting by pediatric patients with cancer for eight weeks was feasible. Mechanisms to enhance three times weekly symptom reporting were identified and implemented. Future studies of longitudinal symptom screening can now be planned., (© 2023. The Author(s).)

This clinical practice guideline provides recommendations for preventing acute and delayed phase chemotherapy-induced nausea and vomiting (CINV) in pediatric patients. The recommendations are based on two systematic reviews of randomized controlled trials evaluating interventions to prevent (1) acute phase CINV and (2) delayed phase CINV. Recommendations for acute phase and delayed phase CINV prophylaxis are made for patients receiving chemotherapy of varying emetogenicity, as well as for patients not able to receive dexamethasone or a neurokinin-1 receptor antagonist. Evidence gaps, including antiemetic safety and optimal dosing, were identified., (© 2022 Wiley Periodicals LLC.)

Purpose: To identify effective and safe interventions to prevent acute phase chemotherapy-induced nausea and vomiting (CINV) in adult and pediatric patients., Methods: We conducted a systematic review of randomized trials evaluating interventions to prevent acute CINV. Outcomes assessed were complete chemotherapy-induced vomiting (CIV) control, complete chemotherapy-induced nausea (CIN) control, complete CINV control, and discontinuation of antiemetics due to adverse effects., Results: The search identified 65,172 citations; 744 were evaluated at full-text, and 295 (25 pediatric) met eligibility criteria. In patients receiving highly emetogenic chemotherapy (HEC), complete CIV (risk ratio (RR) 1.23, 95% confidence interval (CI) 1.05-1.44) and CIN (RR 1.34, 95% CI 1.10-1.62) control improved when olanzapine was added. The addition of a neurokinin-1 receptor antagonist (NK1RA) to a corticosteroid plus a serotonin-3 receptor antagonist (5HT3RA) also improved complete CIV (RR 1.11, 95% CI 1.08-1.14) and CIN (RR 1.05, 95% CI 1.01-1.08) control. Compared to granisetron/ondansetron, palonosetron provided improved complete CIV control when the 5HT3RA was given alone or when combined with dexamethasone. In patients receiving moderately emetogenic chemotherapy (MEC), dexamethasone plus a 5HT3RA improved complete CIV control compared to a 5HT3RA alone (RR 1.29, 95% CI 1.21-1.39). Only a single meta-analysis evaluating the safety outcome was possible., Conclusions: For patients receiving HEC, various antiemetic regimens improved CIV and CIN control. For patients receiving MEC, administration of a 5HT3RA plus dexamethasone improved CIV control. Analysis of antiemetic safety was constrained by lack of data., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Objective: To evaluate the feasibility of a large prospective trial aimed at improving chemotherapy-induced nausea and vomiting (CINV) control in paediatric patients undergoing oral chemotherapy during acute lymphoblastic leukaemia (ALL) maintenance therapy., Methods: English-speaking children, 4.0-17.99 years old and undergoing ALL maintenance treatment with an English-speaking guardian, were eligible to participate in this observational, serial, cross-sectional feasibility study. Data were collected from participants over one to three 7-day periods during months 2-3, 5-6 and 11-12 of ALL maintenance treatment. A future trial was considered feasible if the mean time to enrol 10 patients in each of three data collection periods was ≤1 year with ≥80% of patients returning evaluable data. CINV control was described as a secondary endpoint., Results: Twenty-nine of 31 consenting patients (median age: 6.5 years, IQR: 5.1-9.2) completed the study: 10 in months 2-3, 10 in months 5-6 and 9 in months 11-12. The total time to recruit 29 patients was 1.2 years. In each of the three data collections periods, 72% of the patients provided evaluable data. Complete CINV control was reported in 6/21 (29%) evaluable study periods., Conclusions: A future trial to evaluate interventions to improve CINV control in patients with ALL undergoing oral maintenance chemotherapy as designed in this study is not feasible. An electronic data capture method and deferring patient recruitment until the mid-maintenance to late-maintenance phase should be considered in the design of a future trial., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: While care pathways based upon clinical practice guidelines (CPGs) are important, little is known about optimal approaches to development and adaptation in pediatric oncology. Objectives were to develop care pathway templates for pediatric cancer supportive care that are based upon CPGs and to adapt an infection management care pathway for use at a single institution., Methods: Study phases were as follows: (1) creation of care pathway templates across multiple supportive care topics; (2) refinement of the infection management care pathway template by interviewing pediatric oncology clinicians at a single institution; and (3) adaptation of the infection management care pathway template for use at a different institution., Results: Informed by seven CPGs, an initial iteration of the infection management care pathway template was created. This template was then refined based upon 20 interviews with pediatric oncology clinicians. Adaptation of the infection management care pathway template for use at a different institution required many changes to improve its clinical usability. Specificity and additional information not considered by the source CPGs were incorporated., Conclusion: We developed a process to create care pathway templates across multiple supportive care topics in pediatric oncology and to refine and adapt the infection management care pathway. While we found that the process was feasible, we also identified the need to substantially modify the care pathway during the adaptation process to consider scenarios not addressed by the source CPGs. Future work should measure implementation success., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Epidemiology of Clostridioides difficile infection (CDI) in paediatric cancer patients is uncertain. The primary objective was to describe the prevalence of CDI outcomes among paediatric patients receiving cancer treatments. Secondary objectives were to describe clinical features of CDI, propose a definition of severe CDI and to determine risk factors for CDI clinical outcomes., Methods: A multi-centre retrospective cohort study that included paediatric patients (1-18 years of age) receiving cancer treatments with CDI. Severe CDI definition was achieved by consensus. Univariable and multivariable regression was conducted to evaluate risk factors for CDI outcomes., Results: There were 627 eligible patients who experienced 721 CDI episodes. The prevalence of clinical cure was 82.9%, recurrence was 9.6%, global cure was 75.0% and repeated new CDI episode was 12.8%. The proposed definition of severe CDI was the presence of colitis, pneumatosis intestinalis, pseudomembranous colitis, ileus or surgery for CDI, occurring in 70 (9.7%) episodes. In univariable regression, initial oral metronidazole or initial oral vancomycin were not significantly associated with failure to achieve clinical cure or CDI recurrence. In multiple regression, oral metronidazole was significantly associated with higher odds (odds ratio (OR) 1.7, 95% confidence interval (CI) 1.0-2.7) and oral vancomycin was significantly associated with lower odds (OR 0.4, 95% CI 0.2-0.8) of repeated new episodes., Conclusion: The prevalence of clinical cure was 82.9% and recurrence was 9.6% in pediatric patients receiving cancer treatments. Severe CDI, as per our proposed definition, occurred in 9.7% episodes. Initial oral vancomycin was significantly associated with a reduction in repeated new CDI episodes., Competing Interests: Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Andreas H Groll has research support from Gilead Sciences, Merck Sharp and Dohme, and Pfizer; is a consultant for Amplyx, Astellas, Basilea, F2G, Gilead Sciences, Merck Sharp and Dohme, and Pfizer; and served at the speakers’ bureau of Astellas, Basilea, F2G, Gilead Sciences, Merck Sharp and Dohme, and Pfizer; Thomas Lehrnbecher has an unrestricted research support from Gilead Sciences; is a consultant for Gilead Sciences, Merck Sharp and Dohme, Pfizer, Astellas, and Roche; and serves at the speakers’ bureau of Gilead Sciences, Merck Sharp and Dohme, Astellas, Pfizer, and GlaxoSmithKline. All remaining authors have declared no conflicts of interest., (Copyright © 2022 Elsevier Ltd. All rights reserved.)