Clinical Stakeholders Research Articles

SAT293 Improving Prescribing For Emergency Glucocorticoid Kits In Primary Adrenal Insufficiency

Abstract Disclosure: M.W. Porter: None. K.E. Anderson: None. K.M. Myers: None. S. Friedman: None. S.U. Perez-Martinez: None. J. Adamczyk: None. V. Patel: None. C.D. Hendrickson: None. Introduction: Primary adrenal insufficiency (PAI) is a condition defined by the inability of the adrenal cortex to produce sufficient amounts of glucocorticoids and mineralocorticoids. Adrenal crisis is a complication of PAI which studies suggest approximately 1 in 12 patients will experience in the coming year, with an associated mortality rate of 0.5/100 patient years.1 Endocrine Society guidelines recommend that every PAI patient should be equipped with a glucocorticoid injection kit for emergency use.2 Despite this recommendation, rates of prescription are variable with recently published survey data demonstrating ranges of 30% 3 to 86.5%.4 Aim: The aim of this quality improvement project was to increase emergency glucocorticoid injection prescribing to greater than 80% of patients with Addison’s disease. Methods: Our project first identified baseline data on active emergency glucocorticoid prescription for patients with diagnosis of Addison’s disease and a clinical encounter within the prior year.We then engaged clinical pharmacist stakeholders who were presented these patients and proactively contacted each directly, facilitating prescriptions being sent in the most affordable method to the pharmacy of choice and then notifying the clinician. Results: Retrospective analysis into prescribing patterns at our clinic demonstrated a mean of 54.7% PAI patients with an active prescription for emergency glucocorticoid during 2021. Following a transition period after initiating the intervention in March 2022 there was a statistically significant increase in mean active prescriptions to 88% maintained from May to Nov. 2022 as demonstrated on a statistical process control chart. Discussion/Conclusion: While emergency glucocorticoid is recommended for all patients with PAI, we identified a deficit in prescription patterns that appears consistent with previous data. Numerous challenges exist for consistent prescription practices; however, our intervention demonstrated a reproducible model for increasing access to potentially lifesaving medication in patients with PAI.

Unveiling the Impact of Lean Leadership on Continuous Improvement Maturity: A Scoping Review.

Lean Management (LM) is a process improvement approach with growing interest from healthcare organizations. Obtaining a culture of continuous improvement is a primary objective of LM, and a culture of continuous improvement indicates a mature LM approach, and here leadership plays a central role. However, a comprehensive overview of leadership activities influencing LM maturity is lacking. This study aims to identify leadership activities associated with continuous improvement and, thus, LM, maturity. Following the PRISMA guidelines, a scoping literature review of peer-reviewed articles was conducted in twenty healthcare management journals. The search provided 466 articles published up until 2023. During the selection process, 23 studies were included in the review. The leadership activities related to continuous improvement maturity were identified using the grounded theory approach and data coding. The analysis highlighted a total of 58 leadership activities distributed across nine themes of LM leadership. Next, analysing leadership activities concerning the different maturity levels revealed three maturity stages: beginner, intermediate, and expert. Based on the findings, we propose a framework that guides suitable leadership activities at the various stages of LM maturity. The framework provides leaders in healthcare with a practical overview of actions to facilitate the growth of the LM approach, and the related propositions offer academics a theoretical basis for future studies. This review presents the first comprehensive overview of LM leadership activities in relation to continuous improvement and LM maturity. To enhance LM maturity, leaders are encouraged to consider their leadership style, (clinical) stakeholder involvement, alignment with the organizational strategy, and their role in promoting employee autonomy.

Clinical research stakeholders’ experiences of clinical research during COVID-19: a qualitative study

BackgroundThe COVID-19 pandemic created a complex high-risk clinical research environment with clinical research activities significantly impacted. Clinical research stakeholders adapted rapidly to new clinical practices; PPE, infection control policies, all while engaging with a more unwell patient demographic. The aim of this study is to explore the experiences of conducting clinical research during COVID-19 with clinical research stakeholders.MethodsThis qualitative study of semi-structured interviews conducted with clinical research stakeholders in an acute Hospital setting across a variety of disciplines; Consultant Geriatrician, Clinical Research Nurse, Occupational Therapy, Physiotherapy. Interviews were fully transcribed prior to reflexive thematic analysis. NVivo software was used to support data management and analysis.ResultsThree main themes were produced; (1) The challenging COVID-19 clinical research landscape, (2) COVID-19 clinical research communication barriers, and (3) Adaptations and learnings from clinical research during COVID-19.ConclusionsThis study explored the experiences of conducting clinical research during COVID-19 with clinical research stakeholders examining challenges faced and adaptations required. The findings inform, equip and support clinical research stakeholders in the event of future adverse public health events.

Maternal PlGF and umbilical Dopplers predict pregnancy outcomes at diagnosis of early-onset fetal growth restriction.

BACKGROUNDSevere, early-onset fetal growth restriction (FGR) causes significant fetal and neonatal mortality and morbidity. Predicting the outcome of affected pregnancies at the time of diagnosis is difficult, thus preventing accurate patient counseling. We investigated the use of maternal serum protein and ultrasound measurements at diagnosis to predict fetal or neonatal death and 3 secondary outcomes: fetal death or delivery at or before 28+0 weeks, development of abnormal umbilical artery (UmA) Doppler velocimetry, and slow fetal growth.METHODSWomen with singleton pregnancies (n = 142, estimated fetal weights [EFWs] below the third centile, less than 600 g, 20+0 to 26+6 weeks of gestation, no known chromosomal, genetic, or major structural abnormalities) were recruited from 4 European centers. Maternal serum from the discovery set (n = 63) was analyzed for 7 proteins linked to angiogenesis, 90 additional proteins associated with cardiovascular disease, and 5 proteins identified through pooled liquid chromatography and tandem mass spectrometry. Patient and clinician stakeholder priorities were used to select models tested in the validation set (n = 60), with final models calculated from combined data.RESULTSThe most discriminative model for fetal or neonatal death included the EFW z score (Hadlock 3 formula/Marsal chart), gestational age, and UmA Doppler category (AUC, 0.91; 95% CI, 0.86-0.97) but was less well calibrated than the model containing only the EFW z score (Hadlock 3/Marsal). The most discriminative model for fetal death or delivery at or before 28+0 weeks included maternal serum placental growth factor (PlGF) concentration and UmA Doppler category (AUC, 0.89; 95% CI, 0.83-0.94).CONCLUSIONUltrasound measurements and maternal serum PlGF concentration at diagnosis of severe, early-onset FGR predicted pregnancy outcomes of importance to patients and clinicians.TRIAL REGISTRATIONClinicalTrials.gov NCT02097667.FUNDINGThe European Union, Rosetrees Trust, Mitchell Charitable Trust.

A framework for understanding label leakage in machine learning for health care.

The pitfalls of label leakage, contamination of model input features with outcome information, are well established. Unfortunately, avoiding label leakage in clinical prediction models requires more nuance than the common advice of applying "no time machine rule." We provide a framework for contemplating whether and when model features pose leakage concerns by considering the cadence, perspective, and applicability of predictions. To ground these concepts, we use real-world clinical models to highlight examples of appropriate and inappropriate label leakage in practice. Finally, we provide recommendations to support clinical and technical stakeholders as they evaluate the leakage tradeoffs associated with model design, development, and implementation decisions. By providing common language and dimensions to consider when designing models, we hope the clinical prediction community will be better prepared to develop statistically valid and clinically useful machine learning models.

Providing the basis for a patient-centred and effective screening for cancer-related fatigue (MERLIN study): design of a longitudinal observational study

IntroductionCancer-related fatigue (CRF) is a frequent and burdensome sequela of cancer and cancer therapies. It can persist from months to years and has a substantial impact on patients’ quality of...

Decreasing appointment waiting days for first consultation for patients attending adult weight management clinic in a tertiary hospital

Adult weight management (AWM) clinic at our tertiary institution is a clinical service run for overweight or obese adult women, who are also under the care of gynaecologists for subfertility...

Do Socially Assistive Robots Help in Caring for Elderly Patients with Frailty or Mild Cognitive Impairment?

The burgeoning elderly population, set to double by 2050 worldwide, will place immense demand on provision of elderly care. The mismatch in supply and demand of social care, made worse by the recent Covid-19 pandemic, has heightened the search for viable adjuncts to social care. The purpose of this dissertation is to explore the possible role of socially assistive robots (SAR) in care of elderly patients with frailty or mild cognitive impairment. In the past decade, SAR has emerged as a possible contender for assisted care. Through interviews with frontline NHS clinical stakeholders, review of research articles and visit to the Robot House research facility in the University of Hertfordshire, this project has identified the barriers, limitations to SARs and ethical challenges that needs addressing before the mainstream implementation of SARs to assist in care of the elderly. It is imperative to establish SARs’ safety profile and effectiveness through end-user inclusive, robustly designed, randomized clinical trials addressing the contextual factors of SAR implementation. Particular care and attention should be devoted to ensuring that future studies are enrolled with adequate numbers of participants to achieve statistically significant outcomes of SAR safety and acceptability. With paucity of social care workers and an ever-increasing population of older age adults, SARs will have a potential role to play in supporting the independence and dignity of elderly people in their own environment. SARs offer hope amidst the current social care despair, and further research is key to their eventual success in aged care, which may be years away from reality.

Moving toward targeted eating disorder care for transgender, non-binary, and gender expansive patients in the United States.

Literature suggests that transgender, non-binary, and/or gender expansive (TNG) people are more likely than cisgender peers to experience eating disorders (EDs) and engage in dangerous weight control behaviors. TNG individuals with EDs are dramatically higher risk for self-harm behaviors, suicidal ideation, and suicidal behaviors than cisgender peers with EDs or TNG peers without EDs, and often engage in ED symptoms/behaviors to alleviate gender dysphoria. Yet, no treatment paradigms have yet been adapted for TNG-specific ED care. This qualitative study aims to identify stakeholder needs from such care to inform future clinical interventions. We elicited patient (n = 12) and mental health clinician (n = 9) stakeholder needs and preferences regarding TNG-specific ED care. Semi-structured interview guides informed by the Consolidated Framework for Implementation Research (CFIR) and a behavioral insights framework, EAST, were developed to ensure uniform inclusion and sequencing of topics and allow for valid comparison across interviews. Using a rapid analysis procedure, we produced a descriptive analysis for each group identifying challenges of and opportunities in providing ED care for TNG adults. Stakeholders expressed needs and preferences for TNG-specific treatment including that it be: (1) TNG-affirming, weight-inclusive, trauma-informed, and anti-racist; (2) delivered by an interdisciplinary team, including gender-affirming care clinicians; (3) focused on parsing gender dysphoria from other body image concerns, building distress tolerance, and working toward gender euphoria (rather than body acceptance). Future work is needed exploring ED care delivery models that integrate gender-affirming care services with mental health care. Such models may improve TNG access to ED treatment and recovery. Transgender, non-binary, and/or gender expansive (TNG) experience disproportionately high rates of eating disorders and have unique barriers to accessing care. In individual interviews, TNG adults with eating disorders and mental health clinicians who provide psychotherapy for eating disorders voiced desire for greater availability of TNG-affirming, weight-inclusive eating disorder care, integrated with other gender-affirming care services. This informs future research developing eating disorder care for TNG individuals.

How to Deprescribe Potentially Inappropriate Medications During the Hospital-to-Home Transition: Stakeholder Perspectives on Essential Tasks

PurposeNearly all older patients receiving postacute home health care (HHC) use potentially inappropriate medications (PIMs) that carry a risk of harm. Deprescribing can reduce and optimize the use of PIMs, yet it is often not conducted among HHC patients. The objective of this study was to gather perspectives from patient, practitioner, and HHC clinician stakeholders on tasks that are essential to postacute deprescribing in HHC. MethodsA total of 44 stakeholders, including 14 HHC patients, 15 practitioners (including 9 primary care physicians, 4 pharmacists, 1 hospitalist, and 1 nurse practitioner), and 15 HHC nurses, participated. The stakeholders were from 12 US states, including New York (n = 29), Colorado (n = 2), Connecticut (n = 1), Illinois (n = 2), Kansas (n = 2), Massachusetts (n = 1), Minnesota (n = 1), Mississippi (n = 1), Nebraska (n = 1), Ohio (n = 1), Tennessee (n = 1), and Texas (n = 2). First, individual interviews were conducted by experienced research staff via video conference or telephone. Second, the study team reviewed all interview transcripts and selected interview statements regarding stakeholders’ suggestions for important tasks needed for postacute deprescribing in HHC. Third, concept mapping was conducted in which stakeholders sorted and rated selected interview statements regarding importance and feasibility. A content analysis was conducted of data collected in the individual interviews, and a mixed-method analysis was conducted of data collected in the concept mapping. FindingsFour essential tasks were identified for postacute deprescribing in HHC: (1) ongoing review and assessment of medication use, (2) patent-centered and individualized plan of deprescribing, (3) timely and efficient communication among members of the care team, and (4) continuous and tailored medication education to meet patient needs. Among these tasks, developing patient-centered deprescribing considerations was considered the most important and feasible, followed by medication education, review and assessment of medication use, and communication. ImplicationsDeprescribing during the transition of care from hospital to home requires the following: continuous medication education for patients, families, and caregivers; ongoing review and assessment of medication use; patient-centered deprescribing considerations; and effective communication and collaboration among the primary care physician, HHC nurse, and pharmacist.

A Midwest Stakeholder Evaluation of an Adolescent and Young Adult Cancer Survivor Needs Assessment Survey.

Purpose: Over 87,000 adolescents and young adults (AYAs) are diagnosed with cancer in the United States each year. Improvement in outcomes in the AYA population has lagged that of both younger and older patients. This decrement may be attributable to several factors, including insufficient supportive care services. Our team modified the Needs Assessment & Service Bridge (NA-SB) tool, utilizing an iterative approach with patient and clinician stakeholders to meet the needs of the AYA population at a large Midwestern Cancer Center. Methods: We recruited a 10-member AYA Advisory Board (AB) from our Cancer Center patients, and met five times over 9 months to discuss supportive care and the NA-SB. We recruited a multidisciplinary group of oncology clinicians to assess content validity and conducted interviews with nine clinician stakeholders to discuss implementation. Results: The AB generated a 59-item-modified NA-SB, retaining most of the original NA-SB items and adding several more. Five items with concerns for relevance and/or clarity were revised to create the final 58-item-modified NA-SB. Priorities for implementation were identified by AB and clinician stakeholders. Conclusions: The modified NA-SB thoroughly reflects supportive care needs of our Midwestern AYA cancer survivors. When implemented, the tool may facilitate patient-care team communication and provide data to prioritize development of new supportive care resources. AYA cancer survivors have unique supportive care needs that are insufficiently addressed by current care models; using the modified NA-SB may help address those needs, leading to improved AYA outcomes.

Engaging Cancer Care Physicians in Off-Label Drug Clinical Trials: Human-Centered Design Approach.

Using a human-centered design (HCD) approach can provide clinical trial design teams with a better understanding of the needs, preferences, and attitudes of clinical trial stakeholders. It can also be used to understand the challenges and barriers physician stakeholders face in initiating and completing clinical trials, especially for using off-label drugs (OLDs) to treat unmet clinical needs in cancer treatment. However, the HCD approach is not commonly taught in the context of clinical trial design, and few step-by-step guides similar to this study are available to demonstrate its application. This study aims to demonstrate the feasibility and process of applying an HCD approach to creating clinical trial support resources for physician stakeholders to overcome barriers to pursuing clinical trials for OLDs to treat cancer. An HCD approach was used to develop OLD clinical trial support concepts. In total, 45 cancer care physicians were contacted, of which 15 participated in semistructured interviews to identify barriers to prescribing OLDs or participating in cancer OLD clinical trials. Design research is qualitative-it seeks to answer "why" and "how" questions; thus, a sample size of 15 was sufficient to provide insight saturation to address the design problem. The team used affinity mapping and thematic analysis of qualitative data gathered from the interviews to inform subsequent web-based co-design sessions, which included creative matrix exercises and voting to refine and prioritize the ideas used in the final 3 recommended concepts. The findings demonstrate the potential of HCD methods to uncover important insights into the barriers physicians face in participating in OLD clinical trials or prescribing OLDs, such as recruitment challenges, low willingness to prescribe without clinical data, and stigma. Notably, only palliative care participants self-identified as "frequent prescribers" of OLDs, despite high national OLD prescription rates among patients with cancer. Participants found the HCD approach engaging, with 60% (9/15) completing this study; scheduling conflicts caused most of the dropouts. Over 150 ideas were generated in 3 co-design sessions, with the groups voting on 15 priority ideas that the design team then refined into 3 final recommendations, especially focused on increasing the participation of physicians in OLD clinical trials. Using participatory HCD methods, we delivered 3 concepts for clinical trial support resources to help physician stakeholders overcome barriers to pursuing clinical trials for OLDs to treat cancer. Overall, integrating the HCD approach can aid in identifying important stakeholders, such as prescribing physicians; facilitating their engagement; and incorporating their perspectives and needs into the solution design process. This paper highlights the process, methods, and potential of HCD to improve cancer clinical trial design. Future work is needed to train clinical trial designers in the HCD approach and encourage adoption in the field.

Comparisons of Clinical Competency and Job Responsibilities of Physical Therapists With and Without Postprofessional Training.

Understanding how educational pathways may influence clinical competence and work responsibilities is important in providing guidance to academic and clinic stakeholders and physical therapists (PTs) on PT career development. The purpose of this paper was to compare perceived clinical competency and job duties between PTs with formal mentored postprofessional clinical education with PTs without formal postprofessional clinical education. The understanding of self-perceived clinical competence of PTs overall in the United States is limited, especially as related to the impact of postprofessional education. Furthermore, there is limited understanding of the career pathways and development of job duties of PTs in the United States. Two thousand three hundred thirty-four PTs in the United States. An online survey was sent to licensed PTs. This survey included items measuring self-perceived clinical competency and questions related to weekly job responsibilities. Participants were categorized as residency trained, fellowship trained, or non-residency/fellowship trained. Frequency analyses and Kruskal-Wallis tests with pairwise post hoc tests were performed comparing the 3 groups. Residency-trained (P < .007) and fellowship-trained (P < .001) groups demonstrated elements of higher self-perceived clinical competency compared with the non-residency-/fellowship-trained group. Both the residency- and fellowship-trained groups spent less time with patient care and more time with other responsibilities (e.g., teaching, mentoring, and research) (P < .02) during an average workweek. Fellowship-trained PTs (P < .001) spent more time with administrative duties compared with the non-residency-/fellowship-trained group. Results from this paper demonstrate that residency- and fellowship-trained PTs have elements of higher self-perceived clinical competency and spend more of their job duties outside of direct patient care compared with PTs who were not residency or fellowship trained. These results may help guide PTs, academic institutions, and employers in planning and achieving specific career paths.

Achieving durable compliance with venous thromboembolism prophylaxis in bariatric surgery: 3-year data from a major academic medical center

BackgroundMetabolic and bariatric surgery (MBS) venous thromboembolism (VTE) prescribing practices vary widely. Our institutional VTE prophylaxis protocol has historically been unstandardized. ObjectivesTo create a standardized MBS VTE prophylaxis protocol, track protocol compliance, and identify barriers to protocol compliance and address them with Plan-Do-Study-Act (PDSA) cycles. SettingSingle Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program-accredited academic hospital. MethodsWe conducted a retrospective study for all patients undergoing MBS (January 2019 to September 2022). A multidisciplinary group of bariatric clinicians reviewed literature and developed the following standardized VTE prophylaxis protocol: 5000 units preoperative subcutaneous (SC) heparin within 60 minutes of anesthesia induction and postoperative 40 mg SC low molecular weight heparin (LMWH) within 24 hours of surgery. This protocol was distributed to relevant clinical stakeholders. We assessed monthly compliance rates through chart review. Goal compliance was ≥90%. We identified sources of noncompliance and addressed them with PDSA methodology. ResultsA total of 796 patients were included. Preoperative heparin administration increased from a mean of 47% (107/228) preintervention to 96% (545/568) postintervention (P < .0001), and postoperative LMWH administration increased from 71% (47/66) to 96% (573/597, P = .0002). These compliance rates were sustained for 3 years. Barriers to protocol noncompliance included order set timing errors (n = 45), surgeon error (n = 44), surgeon discretion (n = 40), and nursing error (n = 20). No change in bleeding or VTE rates was observed. ConclusionsDeveloping a standardized VTE prophylaxis protocol, monitoring process measures, and engaging relevant stakeholders in PDSA cycles resulted in drastic and durable improvement in VTE prophylaxis compliance rates.

Audiological Tests Used in the Evaluation of the Effects of Solvents on the Human Auditory System: A Mixed Methods Review.

This study aimed to scope the literature, identify knowledge gaps, appraise results, and synthesize the evidence on the audiological evaluation of workers exposed to solvents. We searched Medline, PubMed, Embase, CINAHL, and NIOSHTIC-2 up to March 22, 2021. Using Covidence, two authors independently assessed study eligibility, risk of bias, and extracted data. National Institute of Health Quality Assessment Tools was used in the quality evaluation of included studies; the Downs and Black checklist was used to assess the risk of bias. Of 454 located references, 37 were included. Twenty-five tests were studied: two tests to measure hearing thresholds, one test to measure word recognition in quiet, six electroacoustic procedures, four electrophysiological tests, and twelve behavioral tests to assess auditory processing skills. Two studies used the Amsterdam Inventory for Auditory Disability and Handicap. The quality of individual studies was mostly considered moderate, but the overall quality of evidence was considered low. The discrepancies between studies and differences in the methodologies/outcomes prevent recommending a specific test battery to assess the auditory effects of occupational solvents. Decisions on audiological tests for patients with a history of solvent exposures require the integration of the most current research evidence with clinical expertise and stakeholder perspectives.

Developing and testing a clinical care bundle incorporating caffeine citrate to manage apnoea of prematurity in a resource-constrained setting: a mixed methods clinical feasibility study protocol

BackgroundApnoea of prematurity (AOP) is a common condition among preterm infants. Methylxanthines, such as caffeine and aminophylline/theophylline, can help prevent and treat AOP. Due to its physiological benefits and fewer side effects, caffeine citrate is recommended for the prevention and treatment of AOP. However, caffeine citrate is not available in most resource-constrained settings (RCS) due to its high cost. Challenges in RCS using caffeine citrate to prevent AOP include identifying eligible preterm infants where gestational age is not always known and the capability for continuous monitoring of vital signs to readily identify apnoea. We aim to develop an evidence-based care bundle that includes caffeine citrate to prevent and manage AOP in tertiary healthcare facilities in Kenya.MethodsThis protocol details a prospective mixed-methods clinical feasibility study on using caffeine citrate to manage apnoea of prematurity in a single facility tertiary-care newborn unit (NBU) in Nairobi, Kenya. This study will include a 4-month formative research phase followed by the development of an AOP clinical-care-bundle prototype over 2 months. In the subsequent 4 months, implementation and improvement of the clinical-care-bundle prototype will be undertaken. The baseline data will provide contextualised insights on care practices within the NBU that will inform the development of a context-sensitive AOP clinical-care-bundle prototype. The clinical care bundle will be tested and refined further during an implementation phase of the quality improvement initiative using a PDSA framework underpinned by quantitative and qualitative clinical audits and stakeholders’ engagement.The quantitative component will include all neonates born at gestation age < 34 weeks and any neonate prescribed aminophylline or caffeine citrate admitted to the NBU during the study period.DiscussionThere is a need to develop evidence-based and context-sensitive clinical practice guidelines to standardise and improve the management of AOP in RCS. Concerns requiring resolution in implementing such guidelines include diagnosis of apnoea, optimal timing, dosing and administration of caffeine citrate, standardisation of monitoring devices and alarm limits, and discharge protocols. We aim to provide a feasible standardised clinical care bundle for managing AOP in low and middle-income settings.

Alpha NSW: What would it take to create a state-wide paediatric population-level learning health system?

The health and well-being of children in the first 2000 days has a lasting effect on educational achievement and long-term chronic disease in later life. However, the lack of integration between high-quality data, analytic capacity and timely health improvement initiatives means practitioners, service leaders and policymakers cannot use data effectively to plan and evaluate early intervention services and monitor high-level health outcomes. Our exploratory study aimed to develop an in-depth understanding of the system and clinical requirements of a state-wide paediatric learning health system (LHS) that uses routinely collected data to not only identify where the inequities and variation in care are, but also to also inform service development and delivery where it is needed most. Our approach included reviewing exemplars of how administrative data are used in Australia; consulting with clinical, policy and data stakeholders to determine their needs for a child health LHS; mapping the existing data points collected across the first 2000 days of a child's life and geospatially locating patterns of key indicators for child health needs. Our study identified the indicators that are available and accessible to inform service delivery and demonstrated the potential of using routinely collected administrative data to identify the gap between health needs and service availability. We recommend improving data collection, accessibility and integration to establish a state-wide LHS, whereby there is a streamlined process for data cleaning, analysis and visualisation to help identify populations in need in a timely manner.

Lung cancer multi-omics digital human avatars for integrating precision medicine into clinical practice: the LANTERN study

BackgroundThe current management of lung cancer patients has reached a high level of complexity. Indeed, besides the traditional clinical variables (e.g., age, sex, TNM stage), new omics data have recently been introduced in clinical practice, thereby making more complex the decision-making process. With the advent of Artificial intelligence (AI) techniques, various omics datasets may be used to create more accurate predictive models paving the way for a better care in lung cancer patients.MethodsThe LANTERN study is a multi-center observational clinical trial involving a multidisciplinary consortium of five institutions from different European countries. The aim of this trial is to develop accurate several predictive models for lung cancer patients, through the creation of Digital Human Avatars (DHA), defined as digital representations of patients using various omics-based variables and integrating well-established clinical factors with genomic data, quantitative imaging data etc. A total of 600 lung cancer patients will be prospectively enrolled by the recruiting centers and multi-omics data will be collected. Data will then be modelled and parameterized in an experimental context of cutting-edge big data analysis. All data variables will be recorded according to a shared common ontology based on variable-specific domains in order to enhance their direct actionability. An exploratory analysis will then initiate the biomarker identification process. The second phase of the project will focus on creating multiple multivariate models trained though advanced machine learning (ML) and AI techniques for the specific areas of interest. Finally, the developed models will be validated in order to test their robustness, transferability and generalizability, leading to the development of the DHA. All the potential clinical and scientific stakeholders will be involved in the DHA development process. The main goals aim of LANTERN project are: i) To develop predictive models for lung cancer diagnosis and histological characterization; (ii) to set up personalized predictive models for individual-specific treatments; iii) to enable feedback data loops for preventive healthcare strategies and quality of life management.DiscussionThe LANTERN project will develop a predictive platform based on integration of multi-omics data. This will enhance the generation of important and valuable information assets, in order to identify new biomarkers that can be used for early detection, improved tumor diagnosis and personalization of treatment protocols.Ethics Committee approval number5420 − 0002485/23 from Fondazione Policlinico Universitario Agostino Gemelli IRCCS – Università Cattolica del Sacro Cuore Ethics Committee.Trial registrationclinicaltrial.gov - NCT05802771.

Research priorities regarding the use of bisphosphonates for osteoporosis: a UK priority setting exercise.

Worldwide, many people who would benefit from osteoporosis drugs are not offered or receiving them, resulting in an osteoporosis care gap. Adherence with bisphosphonates is particularly low. This study aimed to identify stakeholder research priorities relating to bisphosphonate treatment regimens for prevention of osteoporotic fractures. A three-step approach based on the James Lind Alliance methodology for identification and prioritisation of research questions was used. Research uncertainties were gathered from a large programme of related research studies about bisphosphonate regimens and from recent published international clinical guidelines. Clinical and public stakeholders refined the list of uncertainties into research questions. The third step prioritised the questions using a modified nominal group technique. In total, 34 draft uncertainties were finalised into 33 research questions by stakeholders. The top 10 includes questions relating to which people should be offered intravenous bisphosphonates first line (1); optimal duration of treatment (2); the role of bone turnover markers in treatment breaks (3); support patient need for medicine optimisation (4); support primary care practitioner need regarding bisphosphonates (5); comparing zoledronate given in community vs hospital settings (6); ensuring quality standards are met (7); the long-term model of care (8); best bisphosphonate for people aged under 50 (9); and supporting patient decision-making about bisphosphonates (10). This study reports, for the first time, topics of importance to stakeholders in the research of bisphosphonate osteoporosis treatment regimens. These findings have implications for research into implementation to address the care gap and education of healthcare professionals. Using James Lind Alliance methodology, this study reports prioritised topics of importance to stakeholders in the research of bisphosphonate treatment in osteoporosis. The priorities address how to better implement guidelines to address the care gap, understanding patient factors influencing treatment selection and effectiveness, and how to optimise long-term care.

Identifying factors that influence the decision to reduce, delay, or discontinue treatment due to chemotherapy-induced peripheral neuropathy: A community-centered approach.

e13123 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common, debilitating side effect of several chemotherapy agents that may necessitate treatment alteration, i.e., dose reduction, delay, or discontinuation. The decision to alter treatment requires careful consideration between the risk of compromising treatment effectiveness and the benefit of reducing CIPN. Because clinical guidelines do not provide sufficient guidance on when and how to alter treatment in patients experiencing CIPN, it is important to incorporate patients' priorities and preferences in shared decision-making so that the treatment plan aligns with desired outcomes. Currently, little is known about what factors influence the decision to alter treatment from the patient's perspective. Our aim was to identify factors influencing treatment alteration decisions in the context of metastatic breast cancer (mBC). Methods: A community-centered approach was used by engaging oncology clinicians (n = 3) and patients with mBC who experienced CIPN (n = 7). First, the research team conducted a literature review and synthesized 20 factors associated with the decision to alter treatment due to CIPN. Next, researchers presented these factors to clinician and patient stakeholders through individual and group interviews. Clinicians were consulted about the clinical accuracy and relevance of the factors. Patients were asked if factors resonated with their experiences and encouraged to suggest additional ones. To ensure validity, two researchers performed an iterative revision of factors and their descriptions after two individual interviews with patients. Further revisions happened during a group meeting with five patients to ensure that factors and descriptions appropriately described their experience and were comprehensible by others. Results: Eleven factors were identified: (1) fear of decreasing treatment effectiveness, (2) worry of looking back and regretting the decision, (3) opinion of family or friends, (4) recommendation from a medical oncologist, (5) input from other healthcare providers, (6) input from other mBC patients, (7) reduce the worsening of CIPN symptoms, (8) reduce the risk of permanent CIPN, (9) option to switch to alternative treatment less likely to cause CIPN, (10) absence of effective therapies to manage CIPN, and (11) knowledge of the risks and benefits of treatment alteration. Conclusions: Engaging community members was a successful approach to identifying 11 factors influencing treatment alteration decisions in patients experiencing CIPN. In future research, an innovative best-worst scaling (BWS) instrument will measure how patients prioritize these factors. The findings will help inform the development of a patient-centered shared decision-making tool to guide treatment decisions and optimize outcomes.