Central Team Research Articles

PANCASILA VALUES IN THE BOOK OF AL-`ARABIYAH LIL HAYAH AS ARABIC LEARNING MATERIALS

Al-`Arabiyah lil Hayah textbook of volume I contains the values of Pancasila which are in accordance with the five principles of Pancasila, namely Belief in the one and only God, just and civilized humanity, The Unity of Indonesia, Democracy guided by the inner wisdom in the unanimity arising out of deliberations amongst representatives, Social justice for the whole of the people of Indonesia. This article aims to find out the Pancasila values contained in the book al-`Arabiyah lil Hayah volume I which was written by the language development center team of UIN Maulana Malik Ibrahim Malang. The book and the material are the main teaching materials for learning Arabic for new students in the Special Program for Arabic Class UIN Maulana Malik Ibrahim Malang. This research includes descriptive qualitative research. The data were obtained through documents in the form of writing and as research sources, namely the book al-`Arabiyah lil Hayah Volume I. The findings from this study are the values of the five principle of Pancasila contained in the book al-`Arabiyah lil Hayah Volume I and only wahdah (chapter) 3 (three) entitled as-sakan (home) does not contain Pancasila values likely because it focuses on Arabic language learning and may not be intended to address broader sociopolitical principles.

666 Impact of effective cystic fibrosis center team training in a low- to middle-income country

666 Impact of effective cystic fibrosis center team training in a low- to middle-income country

Pancreas Cancer Learning Health Network Established to Share Best Practice Across 14 Centers and Improve Patient Outcomes

Pancreas cancer (PC) survival is among the lowest of all malignancies. Clinical trials have failed to significantly improve outcomes. Individual and institutional biases in care result in significant variation in practice, further hindering progress. Learning health networks (LHNs) prospectively collect real world data across centers and test improvements that can rapidly be expanded across centers if deemed successful. Herein, we report preliminary progress from the Pancreas Cancer Canopy Cancer Collective (PC-CCC), the first oncology LHN, established to improve duration and quality of survival in PC. In 2019, we established the PC-CCC with six care centers who engaged in a collaborative design process to create a set of improvement aims, change ideas, and outcome measures. Center team members receive training and coaching in collaborative quality improvement methods, applied to local improvement efforts. Eight more centers joined in 2021, and a shared Canopy outcomes database was built and implemented to inform center-specific and network-wide improvement efforts and allow the LHN to undertake research using real-world data. Current improvement efforts are focused on proactively screening new PC patients for: (1) Clinical trials, (2) pancreas enzymes, (3) palliative care needs, and (4) goals of care conversations. Currently, 14 care centers are active participants in the PC-CCC LHN. Data on a total of 2,002 PC patients are available to date. At presentation to the care center, most patients are female (51%) and have biopsy proven PC (83.9%). Average age is 68 years, and presenting disease status is metastatic (14.5%), resectable (11.4%), locally advanced (10.9%), borderline resectable (8.1%), or not yet staged (40%). For those who received radiation, 75.8% received stereotactic body radiation therapy. Among patients whose chemotherapy regimen was documented, most received 5-fluorouracilbased treatment (52%). Descriptive follow up data (including treatment and outcomes) are being actively updated, to be reported at time of presentation. Creation of a cancer LHN for PC is feasible and has set the stage for improving patient and provider outcomes through iterative community-building, continuous improvement, and sharing of data and multidisciplinary best practices. Additionally, the data obtained from the CCC database can rapidly inform the network how variation in clinical practice across centers can influence outcomes.

Myoepithelial carcinoma of soft tissues and bone

AimMyoepithelial carcinoma occurs mainly in salivary glands but rarely can also occur in soft tissues or bone. In this paper, we evaluated the role of surgical margins, radiotherapy, and chemotherapy in myoepithelial carcinoma of soft tissue and bone (MC-SB) treated at our Institute. MethodsMedical records of 33 patients presenting with MC-SB between 1998 and 2015 at our institution were retrospectively analysed, and diagnosis and treatment were studied. ResultsThe median follow-up was 58.5 months. Twenty patients had tumours originating in soft tissues and 13 in bone. Eight patients (24.2%) had metastases at diagnosis, the remaining 25 had localised disease. Thirty-two underwent resection of the primary lesion. In 29 surgical margins were evaluated: wide in 28 with 10/28 who recurred (35.7%) and marginal resection in 1 who also recurred. Six patients received adjuvant radiotherapy. Metastases developed in 15/25 patients (60%) with localised disease at onset. Chemotherapy was administered in patients with metastatic advanced disease. Cisplatin+doxorubicin was administered in six patients as first-line chemotherapy with an objective response in 5/6 patients with a median 4-month duration. Five-year overall survival rate was 62.6% in patients with localised tumours and 12.5% in those metastatic at diagnosis. ConclusionsMC-SB showed a high incidence of local recurrences and metastases. Despite different chemotherapy regimens, the outcome remains poor in patients with metastatic disease. Due to the absence of a standard protocol, we encourage treatment by multidisciplinary teams in referral centres with renowned expertise.

Treating acute exacerbations of COPD with Chinese herbal medicine to aid antibiotic use reduction (Excalibur): a randomised double-blind, placebo-controlled feasibility trial.

Background: Although many acute exacerbations of COPD (AECOPD) are triggered by non-bacterial causes, they are often treated with antibiotics. Preliminary research suggests that the Chinese herbal medicine "Shufeng Jiedu" (SFJD), may improve recovery and therefore reduce antibiotic use in patients with AECOPD. Aims: To assess the feasibility of conducting a randomised placebo-controlled clinical trial of SFJD for AECOPD in UK primary care. Methods: GPs opportunistically recruited patients experiencing an AECOPD. Participants were randomised 1:1 to usual care plus SFJD or placebo for 14 days. Participants, GPs and research nurses were blinded to treatment allocation. GPs could prescribe immediate, delayed or no antibiotics, with delayed prescribing encouraged where appropriate. Participants were asked to complete a participant diary, including EXACT-PRO and CAT™ questionnaires for up to 4 weeks. Outcomes included recruitment rate and other measures of study feasibility described using only descriptive statistics and with no formal comparisons between groups. We also conducted qualitative interviews with recruited and non-recruited COPD patients and clinicians, analysed using framework analysis. Results: Over 6 months, 19 participants (6 SFJD, 13 placebo) were recruited. Sixteen (84%) participants returned diaries or provided a diary by recall. Overall, 1.3 participants were recruited per 1,000 patients on the COPD register per month open. Median duration of treatment was 9.8 days in the intervention group vs 13.3 days in the placebo group. The main reason for discontinuation in both groups was perceived side-effects. in both groups. Point estimates for both the EXACT-PRO and CAT™ outcomes suggested possible small benefits of SFJD. Most patients and clinicians were happy to try SFJD as an alternative to antibiotics for AECOPD. Recruitment was lower than expected because of the short recruitment period, the lower incidence of AECOPD during the COVID-19 pandemic, patients starting antibiotics from "rescue packs" before seeing their GP, and workforce challenges in primary care. Conclusion: Recruitment was impaired by the COVID-19 pandemic. Nevertheless, we were able to demonstrate the feasibility of recruiting and randomising participants and identified approaches to address recruitment challenges such as including the trial medication in COPD patients' "rescue packs" and delegating recruitment to a central trials team. Clinical Trial Registration: Identifier, ISRCTN26614726.

Anthropology of Deep Brain Stimulation; the 30th Anniversary of STN DBS in 2023.

The year 2023 marks the 30th anniversary of deep brain stimulation (DBS) of the subthalamic nucleus (STN) for Parkinson's disease (PD). This procedure prompted a universal interest in DBS for various brain disorders and resulted in a unique expansion of clinical and scientific collaboration between many disciplines, with impact on many aspects of society. To study the anthropology of DBS, that is, its ethno-geographic origins, its evolution, its impact on clinicians and scientists, and its influence on society at large. The authors scrutinized the geo-ethnic origins of the pioneers of modern DBS, and they evaluated, based on the literature and on a long-term praxis, the development of DBS and its impact on clinicians, on healthcare, and on society. Scientists and clinicians from various geo-ethnic origins pioneered modern DBS, leading to worldwide spread of this procedure and to the establishment of large multidisciplinary teams in many centers. Neurologists became actively involved in surgery and took on new laborious tasks of programming ever more complicated DBS systems. Publications sky-rocketed and the global spread of DBS impacted positively on several aspects of society, including healthcare, awareness of neurological diseases, interdisciplinary relations, conferences, patient organizations, unemployment, industry, etc. STN DBS has boosted the field of deep brain electrotherapy for many neurological and psychiatric illnesses, and DBS has generated a global benefit on many aspects of society, well beyond its clinical benefits on symptoms of diseases. With the ever-increasing indications for DBS, more positive global impact is expected.

Poster (Health Services, Economics and Policy Change) ID 1985397

Background The Spinal Cord Injury Implementation and Evaluation Quality Care Consortium (SCI-IEQCC) is a quality improvement initiative (began in 2019) with a mission to provide optimal and equitable rehabilitation services for all Canadians regardless of where they live, and to ensure the functional recovery, health and well-being for individuals living with spinal cord injury and disease (SCI/D). Objective To highlight the growing needs of an expanding multisite network and the importance of governance and organizational structures to support the execution of current deliverables while addressing emerging challenges. Design/Methods The SCI-IEQCC has a central team for network management. Administrators/leaders, clinicians with implementation science training, local site implementation teams, and individuals with lived experience comprise the SCI-IEQCC. Implementation and evaluation of indicators and best practices across 10 participating organizations requires: operational oversite; monitoring of project milestones; adherence to regulatory requirements; sustained data quality with linkage for analyses; report card dissemination; information sharing and network updates; strategic planning to map future directions; identification of priorities; and, meeting academic/funding deliverables. Results/Findings SCI-IEQCC has driven improvements in rehabilitation service delivery, performance, utilization of best practices, and increments in staff engagement, training, and knowledge exchange. SCI-IEQCC challenges are derived from the diversity of participating organizations, turnover in leaders, staff shortages, reducing variation in documentation and data management, and ensuring resource continuity. Conclusion The growing complexity of this multisite network necessitate innovative approaches to streamline processes across sites, ensure uniform adherence to regulatory requirements, disseminate innovations in informatics, and assure dedication to its mission and vision.

Platform adaptive trial of novel antivirals for early treatment of COVID-19 In the community (PANORAMIC): protocol for a randomised, controlled, open-label, adaptive platform trial of community novel antiviral treatment of COVID-19 in people at increased risk of more severe disease

IntroductionThere is an urgent need to determine the safety, effectiveness and cost-effectiveness of novel antiviral treatments for COVID-19 in vaccinated patients in the community at increased risk of morbidity and...

Insights from UKCTOCS for design, conduct and analyses of large randomised controlled trials.

Randomised controlled trials are challenging to deliver. There is a constant need to review and refine recruitment and implementation strategies if they are to be completed on time and within budget. We present the strategies adopted in the United Kingdom Collaborative Trial of Ovarian Cancer Screening, one of the largest individually randomised controlled trials in the world. The trial recruited over 202,000 women (2001-5) and delivered over 670,000 annual screens (2001-11) and over 3 million women-years of follow-up (2001-20). Key to the successful completion were the involvement of senior investigators in the day-to-day running of the trial, proactive trial management and willingness to innovate and use technology. Our underlying ethos was that trial participants should always be at the centre of all our processes. We ensured that they were able to contact either the site or the coordinating centre teams for clarifications about their results, for follow-up and for rescheduling of appointments. To facilitate this, we shared personal identifiers (with consent) with both teams and had dedicated reception staff at both site and coordinating centre. Key aspects were a comprehensive online trial management system which included an electronic data capture system (resulting in an almost paperless trial), biobanking, monitoring and project management modules. The automation of algorithms (to ascertain eligibility and classify results and ensuing actions) and processes (scheduling of appointments, printing of letters, etc.) ensured the protocol was closely followed and timelines were met. Significant engagement with participants ensured retention and low rates of complaints. Our solutions to the design, conduct and analyses issues we faced are highly relevant, given the renewed focus on trials for early detection of cancer. There is a pressing need to increase the evidence base to support decision making about all aspects of trial methodology. ISRCTN-22488978; ClinicalTrials.gov-NCT00058032. This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 16/46/01. The long-term follow-up UKCTOCS (2015 20) was supported by National Institute for Health and Care Research (NIHR HTA grant 16/46/01), Cancer Research UK, and The Eve Appeal. UKCTOCS (2001-14) was funded by the MRC (G9901012 and G0801228), Cancer Research UK (C1479/A2884), and the UK Department of Health, with additional support from The Eve Appeal. Researchers at UCL were supported by the NIHR UCL Hospitals Biomedical Research Centre and by the MRC Clinical Trials Unit at UCL core funding (MC_UU_00004/09, MC_UU_00004/08, MC_UU_00004/07). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the UK Department of Health and Social Care.

Improving teamwork in multidisciplinary cross-sector teams: Adaption and pilot testing of a team training for Child Advocacy Center teams

BackgroundEffective teamwork is critical to the mission of Child Advocacy Center (CAC) multidisciplinary teams. Team interventions designed to fit the unique cross-organizational context of CAC teams may improve teamwork in CACs. MethodsA collaborative, community-engaged approach was used to adapt TeamSTEPPS, an evidence-based team training for healthcare, for CAC multidisciplinary teams. The adapted training was piloted with one team and evaluated using mixed methods. Team members completed pre-training (n = 26) and follow-up surveys (n = 22) and participated in qualitative interviews (n = 9). ResultsThe adaptation process resulted in the creation of TeamTRACS (Team Training in Roles, Awareness, Communication, and Support). Participants rated TeamTRACS as highly acceptable, appropriate, feasible, relevant, and useful for CAC teams. They identified positive and negative aspects of the training, ideas for improvement, and future uses for TeamTRACS. ConclusionsTeamTRACS is a feasible approach to team training in CACs, and team members find the content and skills relevant and useful. Additional research is needed to test the effectiveness of TeamTRACS and identify appropriate implementation strategies to support its use.

ANCA-associated vasculitis in a HIV-infected patient:a case-based review

BackgroundThe occurrence of autoantibodies in human immunodeficiency virus (HIV)-infected patients has been previously reported, with a prevalence ranging from 20 to 83%. There are also a few reports of clinically relevant autoantibody profiles in HIV-positive patients that lead to true systemic autoimmune disease; these possible life-threatening diseases have to be considered and treated accordingly.Case presentationHere, we present the case of a 29-year-old female patient with a history of well-controlled HIV infection in the last 6 years who was admitted to our department for the evaluation of acute kidney injury and nephrotic syndrome with active urinary sediment. A diagnosis of systemic antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) with renal and pulmonary involvement was established. The patient was treated with cyclophosphamide, rituximab and tapering glucocorticoids,and the diffuse alveolar hemorrhage resolved, but the evolution of kidney function was unfavorable, which led to the need to initiate hemodialysis. We highlight the importance of establishing the correct diagnosis, treating the disease accordingly and the possible clinical issues that can appear in a patient with HIV infection during immunosuppressant treatment as induction treatment. Additionally, we performed a thorough literature review of ANCA positivity in HIV-infected patients to properly understand the current evidence.ConclusionsAlthough it is not clear whether HIV infection and AAV are causally or coincidentally related, the possibility of this systemic autoimmune phenomenon should be acknowledged by physicians to establish the correct diagnosis and treat the disease accordingly by maintaining a balance between the risks and benefits of immunosuppression in this category of patients, with treatment decisions being made by the members of a multidisciplinary team in centers with experience in AAV.

Leave it in the past - primary treatment modality for high-grade epithelial ovarian cancer is not associated with secondary cytoreduction outcomes: A Memorial Sloan Kettering Cancer Center Team Ovary study

ObjectivesTo compare outcomes of patients with high-grade epithelial ovarian cancer (EOC) who underwent secondary cytoreduction surgery (SCS) after up-front treatment with neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS) versus primary debulking surgery (PDS). MethodsPatients with high-grade EOC who underwent SCS from 2/1/2004–10/31/2021 were classified by up-front treatment. Clinical and treatment characteristics were compared between cohorts. Progression-free survival (PFS2) and overall survival (OS2) following SCS were compared using a Cox model adjusted for stage, age at SCS, and number of years between end of chemotherapy and SCS. ResultsOf 374 patients, 62 (17%) underwent NACT-IDS and 312 (83%) PDS. Justification for NACT was disease extent (n = 57, 92%), comorbidities (n = 3, 5%), and thromboembolism (n = 2, 3%). The NACT-IDS cohort had a higher median age at SCS (64 years [IQR: 56–70] vs 59 years [IQR: 53–66]; P = .03), higher proportion of stage III/IV disease (100% vs 81%; P < .001), and shorter median interval between end of chemotherapy and SCS (1.5 years [IQR: 1.1–2.3] vs 1.9 years [IQR: 1.3–3.1]; P = .01). Achievement of complete gross resection at SCS did not differ between NACT-IDS and PDS (84% vs 88%; P = .18). PFS2 (HR: 1.19, 95% CI: 0.83–1.71) and OS2 (HR: 0.96, 95% CI: 0.57–1.63) did not vary by primary treatment modality after adjusting for clinically relevant covariates. ConclusionsDespite more extensive disease at presentation, patients with high-grade EOC who recur after NACT-IDS seem to have similar surgical and survival outcomes after SCS compared to patients who recur after PDS, suggesting that prior NACT-IDS should not preclude SCS.

Systems resilience in the implementation of a large-scale suicide prevention intervention: a qualitative study using a multilevel theoretical approach

BackgroundResilience, the capacity to adapt and respond to challenges and disturbances, is now considered fundamental to understanding how healthcare systems maintain required levels of performance across varying conditions. Limited research has examined healthcare resilience in the context of implementing healthcare improvement programs across multiple system levels, particularly within community-based mental health settings or systems. In this study, we explored resilient characteristics across varying system levels (individual, team, management) during the implementation of a large-scale community-based suicide prevention intervention.MethodsSemi-structured interviews (n=53) were conducted with coordinating teams from the four intervention regions and the central implementation management team. Data were audio-recorded, transcribed, and imported into NVivo for analysis. A thematic analysis of eight transcripts involving thirteen key personnel was conducted using a deductive approach to identify characteristics of resilience across multiple system levels and an inductive approach to uncover both impediments to, and strategies that supported, resilient performance during the implementation of the suicide prevention intervention.ResultsNumerous impediments to resilient performance were identified (e.g., complexity of the intervention, and incompatible goals and priorities between system levels). Consistent with the adopted theoretical framework, indicators of resilient performance relating to anticipation, sensemaking, adaptation and tradeoffs were identified at multiple system levels. At each of the system levels, distinctive strategies were identified that promoted resilience. At the individual and team levels, several key strategies were used by the project coordinators to promote resilience, such as building relationships and networks and carefully prioritising available resources. At the management level, strategies included teambuilding, collaborative learning, building relationships with external stakeholders, monitoring progress and providing feedback. The results also suggested that resilience at one level can shape resilience at other levels in complex ways; most notably we identified that there can be a downside to resilience, with negative consequences including stress and burnout, among individuals enacting resilience.ConclusionsThe importance of considering resilience from a multilevel systems perspective, as well as implications for theory and future research, are discussed.

Pulmonary benign metastasizing uterine leiomyoma (PBML): a case report and review of the literature.

The authors report the case of a 47-year-old female who presented with a 6-month history of irregular vaginal bleeding and severe hot flushes. The patient had no previous history of gynaecological surgery. Ultrasonography and subsequent MRI identified a suspicious 105×65mm mass involving the right uterine cornu and broad ligament. Computed tomography identified bilateral lung nodules, suspicious for metastases. Histological assessment of the final uterine surgical specimen identified a benign dissecting leiomyoma involving the broad ligament and cervix. BML was diagnosed after thoracoscopic resection of a lung lesion which revealed a histologically identical tumour with entrapped normal lung alveoli. This case shows that there is a minority of patients without previous uterine surgery who still go on to develop pulmonary BML. In our case, a combined treatment approach was adopted, involving substitution of hormone replacement therapy to a non-hormonal alternative, thoracoscopic resection of lung lesions and interval surveillance imaging of the chest. BML is a rare condition but should be considered as a differential in women with pulmonary nodules and a history of uterine leiomyomata. Its diagnosis and subsequent counselling can be challenging; therefore cases should be treated by multidisciplinary teams in tertiary specialized centres.

Metaphorical Adjectives Describing Human in Javanese

This study examines metaphorical adjectives describing humans in Javanese. The metaphorical adjective is literally used to describe nouns other than humans but figuratively used to describe humans. This study aims to describe metaphorical adjectives used to characterize humans figuratively based on their meaning type. This study used a descriptive qualitative approach. The data in this study are adjectives used to describe humans in Javanese metaphorically. The data corpus is taken from written and oral sources. The written sources are taken from the Dictionary of Baoesastra Djawa written by Poerwadarminta dan Javanese Dictionary written by the Language Center Team of Yogyakarta and a Javanese short story from the anthology of Javanese literature short story 2007 Kidung Megatruh (22 short stories) and short story of Yogyakarta Javanese in 2000-2010 (87 short stories). Data analysis techniques are inductive, with identification and classification techniques following research objectives. Based on the result, 43 adjectives are used to describe humans with metaphorical meanings. The adjectives are divided into six types: adjectives of positive character marker, negative character marker, positive mental condition marker, negative mental condition marker, positive physical condition marker, and negative physical condition marker. The use of metaphorical adjectives explaining humans in Javanese shows that the creativity of Javanese linguists is good at utilizing existing lexicons to express ideas by distorting their meaning without creating a new lexicon.

Cleft lip and palate surgery during COVID-19 pandemic in Indonesia: a 36-month experience at the Bandung Cleft Lip and Palate Center.

In Indonesia, the prevalence of cleft lip and palate increased from 0.08% to 0.12% between 2013 and 2018. Children with cleft deformities typically undergo staged surgery. However, the coronavirus disease 2019 (COVID-19) pandemic has had negative impacts on the healthcare sector, including the suspension of elective procedures; this has raised concerns about the safety of performing surgery and the functional consequences of delaying treatment, the latter of which is associated with poor prognosis. The purpose of this study was to report the characteristics of clefts treated by the Bandung Cleft Lip and Palate Center team during the pandemic period. This brief comparative study based on a chart review was conducted at the Bandung Cleft Lip and Palate Center. We statistically evaluated data from all patients treated between September 2018 and August 2021. Frequency analysis was performed to analyze the average number of each procedure by age before and during the COVID-19 pandemic. Data from 18-month periods before (n = 460) and during (n = 423) the pandemic were compared. Cheiloplasty procedures were examined (pre-pandemic, n = 230; pandemic, n = 248); before the pandemic, 86.1% were performed according to the treatment protocol (patient < 1 year old), and this proportion non-significantly dropped to 80.6% during the pandemic (p = 0.904). Palatoplasty procedures were also compared (pre-pandemic, n = 160; pandemic, n = 139); the treatment protocol (patient 0.5-2 years old) was followed for 65.5% of procedures before the pandemic and 75.5% during the pandemic (p = 0.509). Additionally, 70 (mean age, 7.94 years) revision and other procedures were performed before the pandemic and 36 (mean age, 8.52 years) during the pandemic. The cleft procedures performed at the Bandung Cleft Lip and Palate Center did not significantly change during the COVID-19 pandemic.

Operational Challenges of an Asia-Pacific Academic Oncology Clinical Trial.

The Asia-Pacific (APAC) region is a major focus for multinational clinical trials, although its cultural, linguistic, economic, and regulatory diversity pose significant challenges for trial conduct, particularly for academic clinical trials. We describe our experience running the investigator-initiated phase III randomized, fully accrued, Aspirin for Dukes C and high-risk Dukes B Colorectal cancer trial (ASCOLT, ClinicalTrials.gov identifier: NCT00565708, N = 1,587), studying the benefit of aspirin in resected high-risk colorectal cancer. ASCOLT opened in 2008 and is the first large academic adjuvant trial fully conducted in the APAC region. Centrally coordinated by the Trial Management Team at the National Cancer Centre Singapore, it has involved 74 sites across 12 APAC countries/regions, including five middle-income countries. Challenges encountered included regulatory complexity, communication and logistical barriers, limited funding and resources, disparate experience and infrastructure across sites, recruitment holds because of changes in local laws, patient attrition, and disruptions caused by the COVID-19 pandemic. Over 100 contracts and 49 ethics board reviews were required, contributing to a lengthy prestudy preparation time of 2 years and start-up times of approximately 6 months per site. Some of the mitigating actions included engaging local cooperative groups (eg, the Australasian Gastro-Intestinal Trials Group in Australia and New Zealand) and seven contract research organizations to manage sites, regular communication with the central team, transition to electronic data management, and a centralized drug-dispensing system. To ensure an efficient and patient-centered clinical trials environment in the APAC region and sustained growth, we suggest coordinated approaches to harmonize regulatory processes, APAC academic oncology trials consortia to streamline processes and provide governance, and ongoing commitment from governments, funding agents, and industry.

Feasibility and acceptability of social determinants of health data collection in the context of a Children’s Oncology Group trial.

10010 Background: Children who are Black, Hispanic or of proxied low socioeconomic status experience inferior survival outcomes despite receipt of uniform treatment on Children’s Oncology Group (COG) trials. Investigation of mechanisms underlying these disparities and evaluation of interventions to address them has been limited by inadequate data. Prior COG trials have collected child race, ethnicity, insurance and zip code—non-modifiable data elements that are prone to misclassification bias—as proxies for exposure to adverse social determinants of health (SDOH). Collection of parent-reported SDOH data provides key information not previously assessed in COG trials, including modifiable exposures such as household material hardship (HMH): food, housing, utility or transportation insecurity. We report the preliminary feasibility and acceptability of the first COG trial to prospectively embed SDOH data collection. Methods: ANBL1531 (NCT03126916), the current frontline, groupwide COG trial for patients with high-risk neuroblastoma, was amended in September 2019 to include an opt-in, correlative aim to evaluate parent-reported SDOH. Parents of patients &lt; 18 years could opt-in during initial ANBL1531 consent to complete a brief, single-timepoint survey at their enrolling site during Induction Cycle 1. Survey domains included parent-reported demographics, HMH, household income, and social support. Paper/pencil surveys available in English, Spanish or French were self-completed or read-aloud by site personnel and could be administered in any language with an interpreter. Surveys were submitted to a central disparities study team for data cleaning and entry into an electronic database. Results: As of December 31, 2022, 360/413 eligible participants opted-in to the embedded SDOH aim across 101 COG sites (87.2% consent rate). Among participants, 316 surveys (87.8%) were completed a median of 11 days post-enrollment. Four (1.1%) parents declined survey completion (3 withdrew consent). Reasons for non-completed surveys included: survey still pending within protocol-specified window (n = 10), institutional COVID-19 restrictions (n = 6), site scheduling issues (n = 6), patient came off ANBL1531 protocol (n = 5) and unknown (n = 13). Data missingness for HMH, the primary SDOH of interest, was 0.8%. Surveys were administered in English, Spanish, French, Vietnamese, Arabic, Mandarin and Tamil. Conclusions: Collection of parent-reported SDOH data as an optional, embedded component of a groupwide COG trial is feasible and acceptable, as demonstrated by remarkable willingness to participate and infrequency of missing data. Incorporation of this approach in future National Clinical Trials Network trials is essential to inform impactful health equity research, including the development and evaluation of targeted interventions to address outcome disparities.

Lessons From the Delta.

Lessons From the Delta.

Creating and Implementing an Indigenous Evaluation Framework Process With Minnesota Tribes

This article is an exemplar of incorporating traditional Indigenous approaches into evaluation practice and addresses the Eastern Door—Be a Good Relative. Throughout the creation of a process for implementing an Indigenous evaluation framework, the American Indian Public Health Resource Center team came to the work rested and ready in ways that reflected traditional, cultural, and spiritual ways of knowing. Throughout the authors’ process, they respectfully listened and sought to understand first and foremost their Tribal partners and let them guide the authors’ decision-making process for taking the best pathway forward together. The authors are honoured to share their story.