BackgroundProgressive cognitive decline in Alzheimer's disease and other dementias limits decision-making, emphasizing the need for timely discussions about preferred future care. However, advance care planning (ACP) is often delayed due to limited readiness among people with dementia and their family caregivers.ObjectiveTo identify communication strategies (interventions and communication methods) improving readiness for ACP among people with dementia and their family caregivers.MethodsA mixed-methods systematic review was conducted (PROSPERO: CRD42023480187). PubMed, The Cochrane Library, Embase, PsycINFO, and CINAHL were searched in January 2024, with an update in February 2025 through expert consultation. Eligible articles included people with dementia and their family caregivers, communication strategies, and readiness for ACP. Study selection was performed independently by multiple reviewers using predefined eligibility criteria. Data were synthesized using a data-based convergent approach.ResultsOf 517 identified articles, ten were included: quantitative (n = 5), mixed-methods (n = 3), and qualitative (n = 2). Eight articles described interventions, including ACP discussions, education, and self-paced, stepwise tools. Multi-component interventions combining facilitated discussions and educational components and tools showed improvements in readiness, although some outcomes were variable across subgroups or over time. Two articles explored communication methods, emphasizing the facilitator relationship and approach, timing and continuity of ACP discussions, and conversational techniques to support engagement.ConclusionsMulti-component interventions, tools, and communication methods may enhance readiness for ACP. Findings highlight the importance of tailoring ACP to individual needs and training healthcare professionals in facilitating ACP. Future research should develop a consistent framework of readiness and identify the active "ingredients" of ACP interventions.

BACKGROUND:Stereotactic body radiation therapy (SBRT) is increasingly used for bone metastases, but inconsistent endpoint definitions and reporting hinder evidence synthesis and clinical application. This study aimed to establish international consensus recommendations for standardised endpoints, definitions, and reporting parameters in SBRT studies for bone metastases. METHODS:A systematic review of prospective SBRT studies (2014-2024) informed a three-round modified Delphi consensus process conducted from 2024 to 2025. Consensus was predefined as at least 75% agreement. Candidate items were refined through iterative online surveys, qualitative feedback, and a final prioritisation vote by an international multidisciplinary expert panel. RESULTS:Of 114 invited experts, 82 from 20 countries participated in at least one Delphi round. Review of 58 prospective studies showed substantial variability in endpoint definitions, pain and toxicity assessment, radiological response criteria, and timing of outcome evaluation. The panel endorsed 46 reporting items (41 required, 5 recommended) and prioritised core endpoint sets across three clinical contexts: oligometastatic, oligoprogressive, and asymptomatic high-risk bone metastases. Strong consensus was reached for definitions of vertebral compression fracture (92%), time to salvage local therapy (93%), duration of pain response (92%), and time to local progression (90%); pain flare achieved 89% agreement. A revised clinical response framework (C-BRAC), introducing a stable disease category, achieved 91% agreement and was recommended for exploratory use alongside existing criteria. CONCLUSIONS:These recommendations provide a structured framework for designing and reporting SBRT studies in bone metastases and may improve consistency, comparability, and future guideline development.

BackgroundPatients living with advanced cancer often benefit from palliative care. Timely referral to specialist palliative care improves quality of life and reduces potentially inappropriate end-of-life care. Despite these benefits, specialist palliative care is frequently introduced late and inconsistently. This study evaluates whether systematically offering a consultation with the hospital palliative care consultation team (PCCT) to all patients referred for radiotherapy for symptomatic bone metastases improves satisfaction with care.Patients and methodsThe Timely Integration of Palliative Care in Oncology care for patients referred for palliative RadioTherapy (TIPZO-RT) trial follows the Trials within Cohorts design and is embedded within the PRospective Evaluation of interventional StudiEs on boNe meTastases (PRESENT+) cohort. Following cohort enrollment, 246 patients will be randomized (1:1) to either the intervention or control group. Patients in the intervention group are offered a PCCT consultation, which they may accept or refrain from. Patients in the control group are not informed about the trial and continue to receive usual care. After four weeks, patient satisfaction with care (affective behavior, EORTC Satisfaction with Cancer Care core questionnaire (EORTC PATSAT-C33)) will be compared between the groups. Secondary outcomes include symptom burden, quality of life, overall survival, and palliative care utilization. Additionally, in the intervention group, patients' experiences with the consultation are evaluated.DiscussionIntegrating palliative care into oncological care for patients with advanced cancer is essential to deliver comprehensive, patient-centered care that addresses physical, psychosocial and spiritual needs. This pragmatic study may provide evidence to support timely integration of specialist palliative care for all patients with bone metastases who may benefit from specialist palliative care. Using the Trials within Cohorts design, this study generates real-world evidence on the acceptance or need for a consultation with the PCCT, while minimizing disappointment or response bias, as patients in the control group are not informed.Trial registrationClinicalTrials.gov ID NCT06805396. Registered on 25-03-2025.

CONTEXT:Patients with stage IV cancer often experience multiple, sequential symptoms that can co-exist, interact and negatively impact health-related quality of life. Currently, it is challenging to identify patients at risk of developing high symptom burden. OBJECTIVES:To identify subgroups of patients with distinct symptom burden trajectories and characteristics of patients at risk of developing high symptom burden. METHODS:We pooled data from two prospective studies, using the EORTC QLQ-C30 to assess symptom burden at baseline, three, six, nine, and 12 months. We identified subgroups with distinct symptom burden trajectories using group-based multi-trajectory modelling. We assessed which sociodemographic and clinical characteristics were predictive for high symptom burden trajectories using multivariable logistic regression analysis. RESULTS:In 841 patients (mean age 65 years [standard deviation 9.8], 50% male), we identified five subgroups within the symptom scales and six subgroups within the functioning scales. 29% of patients were at risk of both increased symptoms and low functioning, indicating high symptom burden. Younger age, lower educational level, ≥1 comorbidity and hospital admission in the past month were predictive of high symptom burden. CONCLUSION:Approximately one-third of patients with stage IV cancer are at risk of high symptom burden. Our study identified distinct patient profiles that can be used to proactively identify those at increased risk. Timely identification of these patients using symptom monitoring allows clinicians to optimize timely and adequate treatment of coexisting symptoms. These findings highlight the importance of personalized approaches in improving health-related quality of life for patients with advanced cancer.

BACKGROUND:Pain is common in advanced cancer, and its assessment is recognized as crucial for effective management. However, real-world evidence on pain prevalence, relief, and the impact of structured pain assessment across cancer types at the end of life remains limited. METHODS:We analyzed data from 215,317 patients who died from cancer reported to the Swedish Register of Palliative Care (2011-2023). Data are based on validated end-of-life questionnaires completed by healthcare providers after the patient's death. Patient characteristics and provider-reported pain outcomes (prevalence of pain, severe pain, structured pain assessment usage, pain relief) were evaluated. Pain prevalence and relief across cancer types were examined through multivariable logistic regression analyses. RESULTS:Overall, 82% of patients experienced pain and 35% severe pain during their final week of life. Highest pain prevalence occurred in pancreatic, prostate, and bone/soft tissue cancer and lowest in brain/CNS cancers. Complete pain relief was reported in 77% of patients, with lowest odds in patients with prostate and bone/soft tissue cancer and highest odds in patients with brain/CNS cancer. Pain assessment using validated tools was reported in 57% of patients, ranging from 49% in hematological malignancies to 64% in pancreatic cancer. Structured pain assessment was significantly associated with higher odds of complete pain relief both overall (adjusted OR 1.27, 95% CI 1.24-1.30) and across most cancer types. CONCLUSION:Pain remains highly prevalent in patients with cancer at the end of life, with variation in both occurrence and relief across cancer types. Structured pain assessment was consistently associated with higher odds of complete pain relief. These findings underscore the importance of routine, systematic pain assessment and tailored pain management strategies in end-of-life cancer care.

BACKGROUND:End-of-life care affects both patients with advanced cancer and their relatives but is often assessed from only one perspective, namely that of bereaved relatives. This study aimed to gain insight into the quality of care as experienced by patients with advanced cancer and their relatives. METHODS:A total of 367 patients with stage IV cancer, 242 relatives and 163 bereaved relatives were included from a large prospective, longitudinal study (eQuiPe), which ran from November 2017 until March 2020. Patients and their relatives completed a questionnaire during the last 3 months of the patient's life. Bereaved relatives completed a questionnaire within six months after the patient's death. RESULTS:At the end of life, patients reported a mean satisfaction with care score of 72/100 (SD 21), and relatives a mean score of 59/100 (SD 28) for the care they received themselves. Continuity with care, the extent to which the care received from different healthcare professionals was coordinated, was associated with higher satisfaction with care in patients (β 2.1, 95% CI 1.6-2.6). Bereaved relatives reported that most patients died peacefully (87%) and at home (73%). Most bereaved relatives (66%) were contacted by a healthcare professional after the patient's death, but over half were not informed about grief (52%) or the available options for bereavement support (58%), with about 20% reporting they would have appreciated this. CONCLUSIONS:Quality of end-of-life care was generally perceived as good. This study highlights the importance of good continuity of care as it is associated with higher satisfaction with care in patients. Also, one-fifth of the bereaved relatives reported that they had not been informed about bereavement care despite desiring it, which emphasizes the need for better care for relatives before and after the patient's death.

BACKGROUND:Death anxiety in patients with advanced cancer may increase during the last year of life due to increasing symptom burden and growing awareness of prognosis. AIMS:To examine the trajectory of death anxiety during the last year of life in patients with advanced cancer and its associated factors. METHODS:Data from the prospective, multicentre, observational eQuiPe study were used. Patients with stage IV solid cancer were included (2017-2020) and completed three-monthly questionnaires until death. Death anxiety was measured using a single item from the Problem and Needs in Palliative Care questionnaire (yes, a little bit, or no). Additionally, 32 patients completed the Death and Dying Distress Scale (DADDS). Longitudinal analyses were performed using mixed-effects regression. RESULTS:In total, 629 patients were included (mean age: 66 years, SD = 10). During the last year of life, 12%-15% experienced death anxiety, 30%-34% a little, and 52%-58% none. The prevalence of death anxiety remained stable over time and was significantly associated with female sex (OR 2.48), age (OR 0.93), fatigue (OR 1.10), planning (OR 1.84) and acceptance coping (OR 0.20), and social support (OR 1.39). Concerns about the impact of their death on relatives was the most frequently reported issue (84%) in patients with available DADDS data. CONCLUSIONS:The prevalence of death anxiety does not change in the last year of life and is associated with several psychosocial factors. These findings underscore the value of open communication and care approaches that strengthen adaptive coping and address the relational aspects of distress.

Despite its recognized importance in dementia care, advance care planning is frequently postponed. Understanding factors that support and hinder readiness (i.e., an individual’s willingness and ability to engage in advance care planning discussions) is essential, to ensure that people with dementia and their family caregivers can participate effectively in planning for future care. This study aimed to identify factors influencing readiness from the perspectives of people with dementia, family caregivers, and healthcare professionals. Semi-structured qualitative interviews were conducted with people with dementia, family caregivers, and healthcare professionals across multiple care settings in the Netherlands. Inductive qualitative content analysis was used to identify key factors influencing readiness. For people with dementia (n = 6), readiness was facilitated by a desire for autonomy. Readiness was hindered by focusing on the present, surrendering to a perceived lack of control over the future, avoiding sensitive topics, and relying on healthcare professionals to initiate discussions. For both people with dementia and family caregivers (n = 5 family caregivers), readiness was facilitated by a desire to prepare for the future, and hindered by the complexity of advance care planning. (Lack of) collaboration and social support, previous personal experiences, and the relationship with the healthcare professional either facilitated or hindered readiness. No distinct factors were identified solely for family caregivers. Healthcare professionals (n = 13) reported factors related to individual healthcare professionals: difficulty addressing sensitive topics as hindering readiness for advance care planning, while (lack of) personal priority, (limited) education and training, and (lack of) experience either facilitated or hindered it. They also reported factors related to healthcare organizations: interprofessional cooperation and communication facilitated readiness, while (lack of) implementation leadership, (limited) time to implement advance care planning, and (limited) procedural support either facilitated or hindered readiness. Readiness for advance care planning in dementia is dynamic and shaped by personal, relational, and systemic factors. Addressing these factors may facilitate timely and meaningful implementation of advance care planning, ensuring future care aligns with the values and preferences of people with dementia and their families.

PURPOSE:Trials show similar pain outcomes for hypofractionated and multi-fraction regimens in bone metastases, yet clinical adoption of hypofractionation remains limited. The coronavirus disease 2019 (COVID-19) pandemic may have increased hypofractionation to minimize hospital visits and optimize resources. This study evaluated fractionation patterns before, during and after COVID-19 and compared pain outcomes between regimens in routine practice. MATERIALS AND METHODS:Data on treatment regimens for bone metastases between 2018 and 2022 were collected from 11 of 22 Dutch radiotherapy departments. Trends in utilization of hypofractionated (1-2 times 8 Gy) and multi-fraction (≥5 fractions) regimens were analyzed. For a subset of patients (n = 278), self-reported pain scores were collected at baseline, 4 and 8 weeks, and 3 months. Pain scores and pain response were compared for hypofractionated and multiple-fraction regimens, with complete (pain score 0) or partial (reduction ≥2 points) response classified as responders. RESULTS:A total of 17,336 patients were included, receiving 31,677 treatment regimens. The majority of the regimens were hypofractionated (n = 25,790, 81%). The use of hypofractionated regimens ranged from 34% to 99% between radiotherapy departments. A statistically significant increase in hypofractionated regimens was observed since the onset of the COVID-19 pandemic in 2020 (p < 0.001). In an exploratory analysis of patients with available pain scores, pain response in the three months post-treatment did not differ significantly between hypofractionated and multi-fraction regimens (56% vs. 63%, p = 0.406). CONCLUSION:This study demonstrates a high adoption of hypofractionated regimens, with a slight increase since the COVID-19 pandemic, though considerable variation remains between departments. Pain outcomes were comparable between hypofractionated and multi-fraction regimens, suggesting equal palliation and less treatment burden with hypofractionation.

OBJECTIVES:To evaluate the impact of a tailored organizational intervention on the support for family caregivers. METHODS:A convergent mixed-methods study was conducted in 17 organizations (6 hospices, 5 home care organizations, 3 nursing homes, 2 hospitals, 1 transmural organization) between November 2021 and August 2023. The intervention comprised a structured practice improvement trajectory during which each organization conducted a structured workshop to define organization-specific goals to improve their support for family caregivers and to develop an action plan to achieve those goals. The action plan was implemented over 1 year with intermittent evaluations. Pre- and post-intervention surveys were distributed among healthcare professionals (paired) and bereaved family caregivers (non-paired) to assess provided and received support. Data were analyzed with mixed models and regression analyses. Post-intervention focus groups with project team members and final evaluation reports were analyzed with qualitative content analysis. RESULTS:Survey respondents were 97 healthcare professionals (83% nursing staff), 123 family caregivers pre-intervention, and 99 family caregivers post-intervention. Only healthcare professionals of home care organizations reported a significant increase in attending to family caregivers' wellbeing and needs (scale 0-20; β = 3.65; 95%CI: 1.33-5.97). Family caregivers' reports of healthcare professionals attending to their wellbeing and needs did not change (scale 0-2; β = 0.17; 95%CI: -0.04-0.38). Across settings, healthcare professionals evaluated the care they provided more positively post-intervention (scale 0-8; β = 0.65, 95%CI: 0.38-0.97). In home care, family caregivers also evaluated care more positively (scale 0-8; β = 2.12; 95%CI: 0.89-3.34). Four focus groups and 17 evaluation reports indicated improvements at 3 levels: the support for family caregivers (increased awareness of healthcare professionals, changes in work processes, more structured support), the healthcare team (more skills, confidence, available tools), and the organization (fostering sustainability). SIGNIFICANCE OF RESULTS:A tailored organizational intervention can strengthen the support of family caregivers in healthcare organizations.

Timely integration of palliative care has numerous benefits for patients with incurable cancer. Based on a recent national Delphi study on the timely integration of palliative care in oncology, three recommendations were formulated regarding 1) advance care planning (ACP), 2) routine symptom monitoring during the last year of life, and 3) involving the Specialist Palliative Care Team (SPCT) during the last three months of life. This pilot study aimed to assess the feasibility of these recommendations in the Dutch context. Four Dutch hospitals implemented these recommendations for three months. Feasibility was assessed in three ways. First, the extent to which the recommendations were applied was assessed by analysis of electronic medical records (EMRs) of 542 patients with incurable cancer. Second, the extent to which clinicians (n = 27) found the recommendations applicable was assessed using a questionnaire including the Measurement Instrument for Determinants of Innovations (MIDI) and self-administrated questions. Last, patients’ experiences (n = 70) were assessed using the EORTC IN-PATSAT and self-administrated questions regarding using the recommendations. The recommendation on ACP was applied in 49

BACKGROUND:Bone metastases often cause pain and interfere with quality of life (QoL). Survival of patients with bone metastases is increasing and there is a paucity of data about QoL in long-term survivors after external beam radiotherapy. METHODS:Patients with bone metastases treated with radiotherapy were identified from the PRospective Evaluation of interventional StudiEs on boNe meTastases (PRESENT+) cohort. Patient and treatment characteristics were collected before radiotherapy. Patient-reported QoL scores were collected up to 5 years, and included global QoL, physical and emotional functioning, symptoms including pain (EORTC QLQ-C15 PAL) and functional interference and psychosocial aspects (EORTC QLQ-BM22). Dutch reference QoL data were used for comparison. RESULTS:In total, 458 (23%) short-term (<3 months), 915 (46%) intermediate-term (≥3 months and <2 years), and 603 (31%) long-term (≥2 years) survivors were included. Median survival of the full cohort (n = 1,976) was 9.5 months (interquartile range, 3.3-30.5 months). Two third (n = 1,316, 67%) provided QoL scores. Long-term survivors reported a substantial increase in global QoL, emotional and physical functioning, and functional interference 4 weeks post radiotherapy; this improvement persisted over 5 years. Their QoL scores were substantially better than those of short-term and intermediate-term survivors, and somewhat lower than the reference population. CONCLUSION(S):Patients with bone metastases, referred for radiotherapy, represent a highly heterogeneous group. One third survives more than two years with QoL scores comparable to, or somewhat lower than the Dutch reference population. An individualized treatment approach is needed, addressing both short-term symptom palliation and, if applicable, long-term goals.

Pain from spinal metastases can result in significant impact to patients' quality of life. Conventional external beam radiation therapy (cEBRT) has long been shown to be effective in the pain control of patients with spinal metastases. With the advancement in radiation therapy, stereotactic body radiation therapy (SBRT) has been increasingly adopted for the treatment of spinal metastases. Multiple randomised controlled trials (RCT) have been performed to evaluate whether SBRT provides better pain relief compared to cEBRT. Previous meta-analyses showed that SBRT have significantly better complete pain response at 3 months compared to cEBRT. This report updates meta-analyses by incorporating the complete pain response data obtained from personal communication with the NRG Oncology Radiation Therapy Oncology Group (RTOG) 0631 principal investigator and the recently published RCT by Guckenberger et al. The results demonstrate that the results for complete pain response at 3 months have now changed and no longer favour SBRT. It is postulated that inconsistent definitions and reporting of study endpoints, specifically regarding vertebral compression fractures induced by radiation therapy, could be possible reasons for the difference in meta-analyses results. A consensus for standardizing study endpoints for future clinical trials in SBRT for painful bone metastases is needed to allow for better interpretation of study results.

BACKGROUND AND PURPOSE:External beam radiotherapy (EBRT) is a well-established and effective intervention for pain palliation in patients with bone metastases. Variability in trial endpoints, however, has limited comparability and synthesis of available evidence. To address this, the International Bone Metastases Consensus Working Party published endpoint guidelines in 2002 and updated them in 2012. This study aims to review, re-evaluate, and update the existing consensus to reflect contemporary clinical practice and technological advances. MATERIALS AND METHODS:A modified Delphi process was undertaken, informed by a systematic literature review and post-2012 guideline publications. An electronic survey was distributed to previous contributors and internationally recognized bone EBRT experts. In Phase I, statements achieving ≥ 75 % agreement were accepted. Items not reaching consensus were refined by the Working Party, discussed by a core panel of eight experts, and recirculated in Phase II. Descriptive statistics summarized response rates and agreement levels. RESULTS:Of 125 experts invited, 58 participated in Phase I, and 44 in Phase II. Consensus was achieved for 38 out of 49 statements (78%), including 18 new or revised items. Key recommendations addressed eligibility criteria for trial enrolment, standardized pain and analgesic assessments, specification of radiation techniques and dose schedules, follow-up intervals, assessment timing and modalities, and incorporation of cost-effectiveness analyses. CONCLUSION:This updated consensus provides a contemporary, standardized framework for EBRT trial design and reporting in bone metastases. Adoption will improve cross-study comparability and guide future research priorities. Regular updates are planned to ensure alignment with evolving clinical practice and technology.

Purpose:This systematic review evaluated variability in study endpoints among stereotactic body radiation therapy (SBRT) studies for bone metastases. Heterogeneity in endpoint definitions and reporting may hinder cross-study comparability and the establishment of consistent treatment protocols. Methods:A comprehensive search of Ovid MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials identified prospective studies, including cohort studies, phase I/II trials, and randomised controlled trials (RCTs), published between 2014-01-01 and 2024-11-12. Studies were eligible if they: (1) included adult patients with bone metastases treated with SBRT, (2) were prospective, and (3) reported pre-defined clinical endpoints. Results:A total of 58 studies were included: eight cohort studies, 37 phase I/II trials, and 13 RCTs. Pain-related endpoints were the most frequently reported primary endpoints, with pain response reported in 28% (16 studies). Other primary endpoints included toxicities (22%, 13 studies), survival metrics (12%, seven studies), and local control (9%, five studies). Secondary endpoints varied, with survival-related endpoints reported in 60% (35 studies) and toxicity in 41% (24 studies). Endpoint selection differed by clinical scenario, reflecting distinct objectives such as symptom relief, local control, and progression-free survival. Variability in definitions for endpoints, particularly pain flare and vertebral compression fracture, along with inconsistent radiological response criteria, was noted. Conclusion:Considerable heterogeneity in endpoint selection, definitions, and measurement tools across SBRT reflects diverse clinical objectives. Consensus-driven standardisation of endpoints, response criteria, and follow-up schedules is essential to enhance comparability, facilitate evidence synthesis, and support integration of SBRT research findings into clinical practice.

PURPOSE:Palliative care is integrated into hematological malignancy care less frequently than in the care for patients with solid tumors. Therefore, this study aimed to better understand the perspectives and experiences of clinicians regarding integrating palliative care for patients with hematological malignancies. METHODS:Interviews were conducted with clinicians who care for hematological patients. The interviews were analyzed using thematic analysis. RESULTS:Participants acknowledged the importance of integrating palliative care. However, they noted that patients with hematological malignancies often have a more unpredictable disease course than patients with solid tumors. Unpredictability and the potential for rapid deterioration were identified as main barriers to the integration of palliative care. In addition, participants indicated that the availability of multiple treatment options may result in a tendency to prioritize these treatments over integrating palliative care. The participants recommended that palliative care should have a prominent position in the hematology curriculum and suggested that including palliative care topics in conferences could enhance awareness. CONCLUSIONS:To integrate palliative care into hematological malignancy care, it is necessary to enhance the knowledge and awareness of palliative care among hematological clinicians. A two-track approach, where both curative and palliative pathways coexist, could facilitate the integration of palliative care.

Background For patients with metastatic bladder cancer (mBC) palliative chemotherapy is one of the main treatment options. Real-world insights into outcomes are available, but a comprehensive overview of specific treatment details like number of chemotherapy cycles received and (reasons for) adjustments is lacking. Methods A population-based study was conducted, including all patients diagnosed with mBC in the Netherlands between 2016 and 2021 who started chemotherapy as initial treatment. Data on patient, tumor, and treatment characteristics, including number of cycles, adjustments and reasons for adjustments, and survival were collected from the Netherlands Cancer Registry. Treatment patterns and outcomes were analyzed descriptively. Logistic regression analysis was used to identify factors associated with receiving the full guideline-recommended treatment (4-6 cycles). Results A total of 684 patients started first-line chemotherapy, mostly carboplatin-based (54%). Of these patients, 35% did not receive the full course of treatment. Among these patients who received <4 cycles, 24% died within one month of stopping treatment. Male sex and good performance status were independently associated with receiving the full course of treatment. Among patients who did receive a full course of treatment, half still had adjustments to their treatment schedule, which mainly included dose reductions due to side effects. Conclusions Among patients with mBC starting first-line chemotherapy, only a small majority received the recommended number of cycles, and treatment adjustments were common. This suggests that adhering to recommended treatment is challenging, emphasizing the importance of integrating insights on treatment discontinuation and modifications into the shared decision-making process and guideline development. (c) 2024 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)