Consensus Discussion Research Articles

Design and Development of a Specific Questionnaire for Assessing Gastrointestinal Quality of Life After Metabolic and Bariatric Surgery.

The improvement of health-related quality of life (QoL) after metabolic and bariatric surgery (MBS) is an indicator of success. Due to alterations in the upper gastrointestinal (GI) tract after MBS, important changes occur in the GIQoL. Consequently, patients develop new GI symptoms that affect their lifestyle and interpersonal relationships (IIRR). Therefore, questionnaires specifically assessing GIQoL are necessary. This work aimed to design and validate a GIQoL. The questionnaire development process was divided into four phases. Phase I-II consisted of initial items generation through a literature review, expert consensus (Delphi study), and patient discussion groups (14 patients who underwent to BS). In Phase III, the results were analyzed qualitatively and unified, obtaining the "Questionnaire version 0." Currently, phase IV is in process, and it will consist of analysis its psychometric properties for its final validation. After literature review, no GIQoL questionnaires were found in this type of patient. The Delphi study consensus was reached on 8 of 15 proposed items. Most patients recognized a general deterioration of their GIQoL compared to the period prior to surgery. The final questionnaire has 13 questions, covering 3 dimensions: GI and psychological symptomatology, the influence of the eating habits on daily life, and impact of BS on IIRR. This article describes the process of developing a specific GIQoL questionnaire, which will be completed once we have carried out its psychometric analysis. This questionnaire fills a critical gap in the current assessment of GIQoL after MBS, offering a validated and specific tool that can be integrated into clinical practice.

Barriers, facilitators and strategies for the implementation of artificial intelligence‐based electrocardiogram interpretation: A mixed‐methods study

AbstractIntroductionThe implementation of artificial intelligence‐based electrocardiogram interpretation (AI‐ECG) algorithms relies heavily on end‐user acceptance and a well‐designed implementation plan. This study aimed to identify the key barriers, facilitators and strategies for the successful adoption of AI‐ECG in clinical practice.MethodsA sequential explanatory mixed‐methods study was conducted among future AI‐ECG end‐users in the Netherlands, including doctors, nurses, and ambulance professionals, using a clinical scenario involving chest pain. Quantitative data were collected through a three‐round Delphi survey (n = 25) to identify key barriers and facilitators. Building on these findings, qualitative data were gathered through semi‐structured interviews (n = 7) and focus groups (n = 12) to further explain the barriers and facilitators, and discuss relevant implementation strategies.ResultsParticipants expressed a general openness to working with AI‐ECG. Four key barriers and twelve facilitators were identified in the quantitative phase. Participants mentioned the relative advantage of AI‐ECG in the context of recognizing subtle, or rare, ECG abnormalities and assisting in patient triage. However, successful implementation requires end‐users to have trust in the algorithm, clear protocols, actionable model output, integration with existing clinical systems and multidisciplinary implementation teams. Several strategies were proposed to address these challenges, including conducting local consensus discussions, identifying and preparing local champions and revising professional roles.ConclusionsThis mixed‐methods study grounded in established theoretical frameworks identified several barriers and facilitators to AI‐ECG implementation and proposed strategies to address these challenges. These findings provide valuable insights for developing effective implementation plans for AI‐ECG in clinical practice.

"Can I afford to live today?" The emotional toll of navigating the healthcare system with type 1 diabetes.

People with diabetes (PWD) face significant barriers to accessing insulin and diabetes supplies, including high prices, leading some to turn to social media for material support. This study explores emotions among PWD who have relied on assistance from social media networks when navigating access to diabetes medications and supplies (DMS). We conducted a mixed methods study of individuals with type 1 diabetes (T1D) and their caregivers who have used social media to obtain DMS. Participants were recruited through social media based on self-reported use of social media to obtain diabetes support. Transcripts of semi-structured, telephone interviews were analyzed and categorized, and consensus discussions resolved discrepancies and refined definitions of themes. Thirty individuals (mean age 31+/- 8 years, 29 female, 5 caregivers) were interviewed. The analysis revealed four categories of emotions: anxiety and stress, fear of health problems and financial consequences, frustration with the healthcare system, and feelings of powerlessness and vulnerability. Nearly all interviewees reported anxiety or stress due to the financial burden of managing diabetes and fear for their or their child's health and safety. Diabetic ketoacidosis, unnecessary bodily harm or sickness, or fear of dying due to running out of insulin worried participants. Most participants described the process of obtaining DMS to be more stressful than their daily diabetes management. PWD described strong negative emotions related to navigating the healthcare system and acquiring DMS. Policy changes are urgently needed to support to individuals with type 1 diabetes in order to enhance their quality of life, guarantee equitable access to care, and cultivate a more compassionate and inclusive healthcare system. The reported magnitude of stress is notable, especially given the attention typically focused on the stress of diabetes management.

Effectiveness of interventions to support person-centered contraceptive care for adolescents and young adults: a systematic review.

Effectiveness of interventions to support person-centered contraceptive care for adolescents and young adults: a systematic review.

Measuring communicative style in parents of infants with suspected neurodevelopmental disorders: Reliability test and adaptation of the RAACS instrument.

Measuring communicative style in parents of infants with suspected neurodevelopmental disorders: Reliability test and adaptation of the RAACS instrument.

Human-AI Interaction in the ScreenTrustCAD Trial: Recall Proportion and Positive Predictive Value Related to Screening Mammograms Flagged by AI CAD versus a Human Reader.

Background The ScreenTrustCAD trial was a prospective study that evaluated the cancer detection rates for combinations of artificial intelligence (AI) computer-aided detection (CAD) and two radiologists. The results raised concerns about the tendency of radiologists to agree with AI CAD too much (when AI CAD made an erroneous flagging) or too little (when AI CAD made a correct flagging). Purpose To evaluate differences in recall proportion and positive predictive value (PPV) related to which reader flagged the mammogram for consensus discussion: AI CAD and/or radiologists. Materials and Methods Participants were enrolled from April 2021 to June 2022, and each examination was interpreted by three independent readers: two radiologists and AI CAD, after which positive findings were forwarded to the consensus discussion. For each combination of readers flagging an examination, the proportion recalled and the PPV were calculated by dividing the number of pathologic evaluation-verified cancers by the number of positive examinations. Results The study included 54 991 women (median age, 55 years [IQR, 46-65 years]), among whom 5489 were flagged for consensus discussion and 1348 were recalled. For examinations flagged by one reader, the proportion recalled after flagging by one radiologist was larger (14.2% [263 of 1858]) compared with flagging by AI CAD (4.6% [86 of 1886]) (P < .001), whereas the PPV of breast cancer was lower (3.4% [nine of 263] vs 22% [19 of 86]) (P < .001). For examinations flagged by two readers, the proportion recalled after flagging by two radiologists was larger (57.2% [360 of 629]) compared with flagging by AI CAD and one radiologist (38.6% [244 of 632]) (P < .001), whereas the PPV was lower (2.5% [nine of 360] vs 25.0% [61 of 244]) (P < .001). For examinations flagged by all three readers, the proportion recalled was 82.6% (400 of 484) and the PPV was 34.2 (137 of 400). Conclusion A larger proportion of participants were recalled after initial flagging by radiologists compared with those flagged by AI CAD, with a lower proportion of cancer. ClinicalTrials.gov Identifier: NCT04778670 © RSNA, 2025 See also the editorial by Grimm in this issue.

Evaluation of adherence to the Preferred Reporting of CasE Series in Surgery (PROCESS) 2020 guideline in case series describing endovascular management of vein of Galen malformation demonstrates suboptimal reporting practices.

Interventional neuroradiology is a dynamic field with technological advancements constantly driving evolution in clinical practice. Case series provide interventional neuroradiologists the opportunity to describe the clinical implications of novel equipment and techniques almost in real-time, informing broader adoption and directing future research. Complete reporting in case series is vital in enabling readers to detect bias, determine the generalizability of results and replicate study methodology. The aim of this study was to assess the quality of reporting in case series describing endovascular management of vein of Galen malformations. A systematic search for case series describing endovascular management of vein of Galen malformations in paediatric patients was conducted using a previously published search strategy in Medline, Embase and Web of Science in February 2024. Screening and data extraction were performed by two independent reviewers with disagreements resolved by consensus discussion. Quality of reporting was assessed using adherence to the Preferred Reporting of CasE Series in Surgery (PROCESS) 2020 checklist. We included 19 case series representing a broad range of approaches and endovascular techniques for management of vein of Galen malformations. Overall adherence to the PROCESS 2020 guideline was moderate with a mean of 7.0/13 (54%; range 5.2 - 9.7/13; SD 1.1) items reported. The most consistently reported items related to characteristics of the clinical cohort and details regarding the specific image-guided intervention(s) provided. Items relating to study design, source of funding, pre-intervention patient optimisation, clinical follow-up and potential complications and alternatives for novel techniques/devices were less frequently reported. The quality of reporting in case series describing endovascular management of vein of Galen malformation is suboptimal. Measures to improve the quality of reporting in neurointerventional case series include mandating adherence to reporting guidelines in journal instructions for authors and requiring submission of completed copies of relevant reporting guidelines alongside manuscripts.

A qualitative study of how clinicians reach agreement in perioperative pathway development: the Consensus Model for Standardising Healthcare.

Variation in perioperative care persists globally. Consensus discussions may facilitate standardisation, yet the processes used to reach agreement are poorly understood. This study aimed to develop a model for conducting local consensus discussions when implementing standardised perioperative pathways. Specifically, we 1) describe how local consensus discussions are operationalised; 2) identify what guides decision making and consensus between clinicians; and 3) formulate explanatory mechanisms and identify determinants that facilitate consensus discussions. A qualitative, modified grounded theory study was conducted in one private hospital in metropolitan Sydney, Australia. Thirty-one participants from clinical disciplines and hospital management/leadership were included. Data were collected from nine semi-structured interviews and 16h of participant observations during consensus development or implementation meetings. Data collection and analysis occurred concurrently until theoretical saturation was achieved. Interviews and field notes were recorded and transcribed verbatim. Data were analysed using coding, constant comparison, detailed memo writing and data interpretation. Seven individual and contextual factors crucial for building consensus, and eight mechanisms for reaching agreement were identified and integrated into a conceptual model. Seeking evidence to support decision-making emerged as the primary driver of consensus. Strong research evidence in support of a pathway component facilitated swift agreement. Where there was ambiguous evidence for a pathway component, clinicians based their decisions on a desire for professional autonomy, consideration of how their peers practice, patient preferences, practices from external organisations, or the feasibility of implementing the pathway component. The Consensus Model for Standardising Healthcare provides a map for healthcare organisations seeking to conduct local consensus discussions to reduce variation in care. Our findings advance our understanding of how local consensus discussions are conducted and factors that impact success when standardising care amongst clinicians.

Investigating the Accuracy and Consistency of ChatGPT in the Management of Achilles Tendon Ruptures.

Background The emergence of generative artificial intelligence, such as ChatGPT (OpenAI, San Francisco, CA, USA), offers significant potential for improving the delivery of patient information and aiding in clinical decision-making. The aim of this study was to investigate the accuracy and consistency of ChatGPT in providing patient information and answering orthopaedic clinical questions regarding Achilles tendon ruptures. Methods Eight questions regarding Achilles tendon rupture management were presented to ChatGPT twice, resulting in 16 responses. References were requested for all responses. Each response was evaluated for accuracy and consistency, utilising a grading scale ranging from I (comprehensive) to IV (completely incorrect). Final grading was determined through consensus discussions among two orthopaedic registrars and two senior orthopaedic surgeons. Descriptive statistics were performed. Results All of the responses produced by ChatGPT were graded as containing both correct and incorrect information (grade III). Consistency was observed in six out of eight (75%) questions when comparing the two responses for each question. ChatGPT provided 47 references, with 16 out of 47 (34%) correct, 19 out of 47 (40%) incorrect, and 12 out of 47 (26%) fabricated. Conclusion ChatGPT lacks accuracy and consistency in providing information on the management of Achilles tendon ruptures. All patient information and orthopaedic clinical decision-making recommendations contained inaccurate or fabricated information.

Chinese consensus report on the assessment and management of obstructive sleep apnea in patients with cardiovascular disease: 2024 edition.

Chinese consensus report on the assessment and management of obstructive sleep apnea in patients with cardiovascular disease: 2024 edition.

Antimicrobial Stewardship in Ireland (2010-2021): a scoping review protocol

Background Antimicrobial stewardship programmes (ASP) are essential in promoting responsible antimicrobial use, reducing antimicrobial resistance (AMR) and health care-associated infections. In 2009 the Strategy for the Control of Antimicrobial Resistance in Ireland (SARI), Hospital Antimicrobial Stewardship Working Group published guidance on antimicrobial stewardship (AMS) in hospitals. This paper presents a protocol for a scoping review which aims to examine the current literature to evaluate progress related to the implementation of the SARI (2009) guidance on antimicrobial stewardship in hospitals in Ireland. Methods This scoping review will be conducted in line with the five-stage methodological framework by Arksey &amp; O’Mally 2005. We will search the following databases (PubMed, CINAHL, Embase, Web of Science) and targeted websites for articles and reports for possible inclusion in our review. Studies pertaining to AMS undertaken or related to the Republic of Ireland from January 2010 until December 2021 will be included. We will include all study designs. We will map all selected publications to the recommendations of the SARI (2009) guidance document. The protocol follows the guidance of Peters et al., 2022. Two reviewers will independently screen studies and reports to assess eligibility with any discrepancies resolved by consensus discussion with a third reviewer. Results These will be reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for Scoping Reviews (PRISMA-ScR)and this checklist will be included when the scoping review is published. Conclusion This scoping review will map studies and reports to evaluate AMS in relation to national guidelines without restriction on study design or outcomes in the Republic of Ireland. This information has the potential to provide a valuable resource for the implementation of future AMS research and interventions.

Insights From Diverse Perspectives on Social Media Messages to Inform Young Adults With Cancer About Clinical Trials: Focus Group Study.

Low rates of adolescent and young adult (YA; aged 15-39 y) clinical trial enrollment (CTE), particularly among underserved groups, have resulted in a lack of standardized cancer treatments and follow-up guidelines for this group that may limit improvement in cancer treatments and survival outcomes for YAs. To understand and address unique barriers to CTE, we conducted focus groups to learn about informational, financial, and psychosocial needs of YAs surrounding CTE and identify strategies to address these barriers. We conducted 5 focus groups in 2023 among a diverse sample of YA patients from across the United States. An interview guide was developed collaboratively with YA advocates. Specifically, informational needs, financial concerns, and psychosocial issues were explored, and participants were probed to suggest strategies, especially those that leverage technology, to address these barriers. Sessions were audio recorded, transcribed, and coded using direct content analysis. Findings were synthesized through consensus discussions. We confirmed the previously proposed thematic barriers regarding YA CTE and identified 9 subthemes: awareness, lack of clear and accessible CTE information, fear of the unknown, assumptions about costs, insurance coverage, navigating financial responsibilities, clinical trial discussions, clinical trial misconceptions, and desire for a support network. Throughout, YAs mentioned needs that might be addressed through informational outreach leveraging digital technology, the internet, and social media. This study expands knowledge of YA perceived barriers to CTE. These findings suggest that leveraging digital technology to disseminate reliable information to address needs may be an effective strategy to improve clinical trial participation in the YA population.

Practical considerations for engaging staff in resource-constrained healthcare settings in implementation research: A qualitative focus group and consensus building study

Abstract Background: The primary purpose of this study was to assess perceived burdens and benefits of participating in implementation research among staff employed in resource-constrained healthcare settings. Another objective was to use findings to generate considerations for engaging staff in research across different phases of implementation research. Methods: This qualitative focus group and consensus building study involved researchers affiliated with the National Cancer Institute Implementation Science Centers in Cancer Control program and nine Community Health Centers (CHCs) in Massachusetts. Six focus groups (n = 3 with CHC staff; n = 3 with researchers) assessed barriers and facilitators to staff participation in implementation research. During consensus discussions, we used findings to develop considerations for engaging staff as participants and partners throughout phases of implementation research. Results: Sixteen researchers and 14 staff participated in separate focus groups; nine researchers and seven staff participated in separate consensus discussions. Themes emerged across participant groups in three domains: (1) influences on research participation; (2) research burdens and benefits; and (3) ways to facilitate staff participation in research. Practical considerations included: (a) aligning research with organizational and staff values and priorities; (b) applying user-centered design to research methods; (c) building organizational and individual research capacity; and (d) offering equitable incentives for staff participation. Conclusions: Engaging staff as participants and partners across different phases of implementation research requires knowledge about what contributes to research burden and benefits and addressing context-specific burdens and benefits.

LGBTQIA+ AD/ADRD CAREGIVERS’ PERCEPTIONS OF THE ACCEPTABILITY OF A LEGAL AND FINANCIAL PLANNING TRAINING TOOL

Abstract LGBTQIA+ identifying informal caregivers for people living with Alzheimer’s Disease (AD) and AD-related dementias (AD/ADRD) face multiple, overlapping stressors related to identity stigmatization and role-based burden. This includes legal/financial planning, as the legal landscape surrounding LGBTQIA+ identity is inconsistent and ever-changing. Part of a larger project, this study examined LGBTQIA+ identifying caregivers’ perceptions of the acceptability of CareVirtue Planner, a web-based legal and financial planning support tool for AD/ADRD caregivers. Semi-structured interviews with LGBTQIA+ caregivers (n=9) were conducted after three months of use. We conducted an inductive content analysis using the following process: open coding, collaborative generation of the initial codebook, dual coding with the codebook, consensus discussion on refinements to finalize codebook. Our analysis resulted in four overarching themes among users: sense of commonality and personal validation related to legal and financial challenges of caregiving, Planner features promoting caregiver preparedness, inclusive language and need for LGBTQIA+ specific tailoring, and individual characteristics and personal histories impacting relative usefulness of the Planner. Participants broadly found Planner material to be well organized and its features useful (e.g., document storage ‘vault’), with content best suited for those early in the caregiving journey. Users provided specific recommendations to increase LGBTQIA+ appropriateness, including creation of additional content to specifically address unique legal challenges facing LGBTQIA+ caregivers, inclusion of diverse families in materials (e.g., vignettes), and vetting of externally linked resources for LGBTQIA+ inclusiveness. Further research is needed to support LGBTQIA+ AD/ADRD caregivers navigating complex legal and financial situations.

Factors Influencing the Outcome, Mechanism, and Implementation of Motivational Interviewing After Hip Fracture: A Qualitative Analysis.

Motivational interviewing, an evidence-based person-centered counseling style, may help to facilitate increased mobility and physical activity after hip fracture. We explored contextual factors influencing the outcome, mechanism, and implementation of motivational interviewing after hip fracture. A qualitative study was completed using an interpretive description framework. Data sources included verbatim transcriptions of interviews with purposively sampled patients (n=18), clinicians (n=6 including 3 physical therapists), and relevant physical therapy stakeholders (a trial coordinator, a manager, and physical therapists involved in trial recruitment; n =4), and 128 randomly selected clinician diaries where clinicians recorded notes at the end of each motivational interviewing session. Data were independently coded by 2 researchers and mapped to the Medical Research Council process evaluation framework. Consensus discussions involving all researchers were completed to triangulate the data and develop an interpretive synthesis. We found 3 main themes and 3 subthemes in the data. The main themes were: (a) It's about life, (b) Walking is not the goal, and (c) It's complicated. The last theme was further developed into a model depicting internal, external, and social factors influencing the outcome, mechanism, and implementation of motivational interviewing after hip fracture. Internal factors related to physical and psychological functioning. External factors included elements related to the environment and health services. Social factors included having a support system, receiving positive feedback, isolation, and feeling overwhelmed. Factors interplayed to create a multitiered model, with the person's life at the center. Traditional rehabilitation was perceived as addressing the physical factors of hip fracture, while motivational interviewing intervention was considered to address the whole person. Many contextual factors interplay to influence motivational interviewing intervention after hip fracture. For successful hip fracture rehabilitation, our results suggest physical therapists and other care providers address these factors in addition to physical rehabilitation and focus on the person at the center of the process.

Ergonomics in Laparoscopic Box Training and Virtual Reality (VR) Simulations: A Systematic Review.

Laparoscopic surgery has now become the gold standard in managing most surgical cases. Despite its advantages, working hours and in-theatre training restrictions have prompted trainees to explore alternatives like virtual reality (VR) simulations and box training. Furthermore, given the increased frequency of minimally invasive surgery and the prevalence of musculoskeletal issues among surgeons, there's a growing effort to optimize ergonomics. There is currently a lack of focus on ergonomics in training, prompting our study to inspect VR and box training's ergonomic outcomes and their impact on task performance. This systematic review was conducted at Barts Cancer Institute, Queen Mary University, from January 27, 2024, to April 22, 2024. Multiple databases were searched electronically from January 1980 to March 2024, including only articles that utilized electromyography (EMG) or the NASA Task Load Index (NASA-TLX) to measure ergonomics. Two reviewers independently conducted eligibility assessment, data extraction, and risk of bias evaluation, with discrepancies resolved through consensus discussions. Ultimately, 12 studies were selected. EMG results indicated a higher %MVC (maximum voluntary contraction) in box training in poor ergonomic settings and a negative correlation between skills and muscle activity. Both modalities showed a significant decrease in NASA-TLX scores after training on the simulators and when comparing novice and experienced surgeons. Furthermore, a reduction in physical demand and improved task performance was observed, with significant differences found between experts and novices in a VR appendicectomy scenario. This systematic review reveals reduced muscle activity and physical demand among trained individuals in laparoscopic surgery with both box trainers and VR simulators, emphasizing the importance of addressing ergonomic considerations. To advance our understanding of surgical ergonomics, the standardization of measurement methods and higher-quality evidence, particularly through randomized controlled trials, are recommended.

Family participation in dignity interventions for patients with cancer receiving palliative care: a scoping review protocol

IntroductionThe global burden of cancer is escalating, with Asia accounting for over half of cancer-related deaths worldwide. As cancer often diminishes patients’ quality of life and sense of dignity, dignity-related...

Leveraging group model building to operationalize implementation strategies across implementation phases: an exemplar related to child maltreatment intervention selection

BackgroundImplementation strategies can help support the adoption and implementation of health interventions that are appropriate for a local context and acceptable to decision makers and community members. Implementation strategies should be designed to handle the complexity of the multi-level, dynamic contexts in which interventions are implemented. Systems science theories and methods explicitly attend to complexity and can be valuable for specifying implementation strategies. Group Model Building (GMB) combines research partner engagement strategies with systems science to support researchers’ and partners’ learning about complex problems and to identify solutions through consensus. This paper specifies how GMB can operationalize implementation strategies — methods for supporting evidence implementation in real-world practice — and describes how GMB can aid in selecting and tailoring both health interventions and implementation strategies. A case study in child maltreatment prevention planning is provided to illustrate how GMB was used to specify the “actions” — strategy activities — for three implementation strategies (conduct local consensus discussions; build a coalition; model and simulate change) during the earliest implementation phases, with the goal of supporting intervention selection decisions. Examples are provided of generalizable research products that can be produced concurrently through GMB, in addition to contextually-driven implementation support.MethodsParticipants (n = 8) were engaged over four sessions using tailored GMB activities. Participants generated a qualitative system dynamics model that described their theory of change for how to prevent child maltreatment in their communities. This theory of change reflected a dynamic understanding of the interconnected determinants of child maltreatment.ResultsGMB was acceptable to participants and resulted in products that could be used for implementation planning (e.g., to model and simulate change) and future research. GMB fostered trust and idea sharing between participants.ConclusionGMB can facilitate learning about which outcomes are (or are not) impacted by interventions, which resources and approaches are required for quality implementation (e.g., implementation strategies), and tradeoffs in outcomes and resources between interventions. GMB also provides a structured, effective process to generate a shared implementation vision amongst participants. Lessons learned include methods for developing trust with and between participants, and the need for researchers to tailor GMB actions for participant and project needs.

CTNI-49. PRECISION MEDICINE CLINICAL TRIAL FOR ADULT PATIENTS WITH RECURRENT GLIOBLASTOMA

Abstract Salvage therapies for recurrent glioblastoma (rGBM) have limited efficacy, with median overall survival of 9 months (OS-9) and 6-month progression-free survival (PFS-6) of 10-25%. Given GBM’s molecular heterogeneity, targeting a single molecular abnormality in isolation has consistently failed as a strategy, and precision combination approaches are needed. An initial 15-patient cohort evaluated the feasibility and safety of treating patients with rGBM with an individualized treatment regimen; we added a second 15-patient expansion cohort to improve the power of preliminary efficacy assessment. Patients underwent clinically indicated surgery with genomic profiling using the UCSF500 targeted DNA sequencing panel. Each personalized treatment regimen combined up to 4 FDA-approved drugs, including one cytotoxic agent, as determined by consensus discussion at an individualized molecular tumor board for each patient. Bevacizumab was not utilized in these combinations. The primary objective of the combined 30-patient cohort was efficacy of individualized treatment regimens by OS-9; secondary objectives included safety and additional efficacy measures including PFS-6. Median age was 53 years (range 32-71). Of 30 patients, 18 were male, 23 were enrolled at first recurrence, 29 had IDH-wildtype glioblastoma, 1 had IDH-mutant astrocytoma, and 10 had MGMT promoter methylation. A total of 12 FDA-approved drugs were used in 18 combinations; the most common regimen prescribed was lomustine, afatinib, and abemaciclib (7; 23%,); second-most common was temozolomide, olaparib, and afatinib (4; 13%). OS-9 of the combined cohort was 70% (95% CI 0.55 – 0.89) and PFS-6 was 27% (95% CI 0.15 – 0.48), with median OS of 11.6 months (95% CI 9.7 – 16.7) and median PFS of 3.7 months (95% CI 2.0 – 5.5).While overall efficacy was modest, implementation of individualized treatment regimens in a timely fashion was safe and feasible for patients with surgically resectable rGBM. Analysis is ongoing to assess whether specific genomic profiles or treatment regimens were particularly efficacious.

Determinants of physical activities in settings (DE-PASS): Approach for selecting the core measures for determinants of physical activity behaviours in 9-12 old children

ABSTRACT In large transdisciplinary research teams finding the balance between using the most appropriate and needed measures for data collection and minimising participant burden is often a significant challenge. This paper aims to describe the development process for selecting a set of determinants of physical activity behaviours in 9–12 years old children. An internal small group (n = 8) worked iteratively with an external large group of experts and stakeholders (n = 30-50) in three steps: 1) External input – Identification through expert opinion; 2) Internal input – Identification and selection via a systematized approach; 3) External validation of the selected measures. During these steps, 113 measures were first identified, then scored, sorted, and selected using evidence-building practices such as systematic literature reviews, peer-review, and consensus discussions. Eighteen measures were agreed and included in the core measures toolkit (child and caregiver questionnaires). In conclusion, pragmatism, implementation concerns, and the experts’ experience were key in this process. This process may be considered as a reference to others involved in the challenge of selecting measures in their research.