A Nationwide Study to Evaluate Accessibility to Specialized Pediatric Palliative Care in Italy-Patients, Needs, and Critical Issues: The PalliPed Study.

Background: PalliPed is the first Italian nationwide project aimed at describing the characteristics of patients accessing specialized pediatric palliative care (PPC) and their families, in the main care settings (hospice, home care, and hospital). The project's secondary aim is to assess the extent and quality of regional PPC networks/facilities and the number of dedicated resources. In this article, we present the results of the first part of the project. Methods: All Italian PPC centers/facilities were invited to participate in the project. Children and young adults in the care of the specialized PPC networks/structures as of 24 October, 2022, including prenatal care, were involved. Children's eligibility for specialized PPC was assessed according to the Assessment Form for Complex Clinical Needs in Pediatrics (ACCAPED Scale) and after a multidisciplinary assessment by the healthcare team. Data were collected through an online survey. Results: A total of 867 patients were described. The lack of adequate specialized PPC service emerged, according to the available estimate of specialized PPC needs, as well as the need for improved referral to PPC by pediatricians or territorial services, particularly for infants and oncological patients. More family support measures also seem necessary, particularly for the mothers. Healthcare providers' communication skills should be improved to ensure greater involvement of patients and families in care decisions. Conclusions: This analysis represents the first step toward defining a constantly updated database for the census and monitoring of specialized PPC activities at the national level. This research model can be extended to other realities in different countries, allowing comparison of different care models.

Is it early enough? The authentic meaning of the pediatric palliative approach between early and late referral in pediatric oncology: a case study.

The literature widely supports the benefits of early integration of palliative care into pediatric oncological care; however, many barriers to its successful integration remain. Integrating palliative care as early as possible in the oncology pathway is critical, but other criteria are relevant to positive results. This paper aims to contribute to the early/late referral dualism in pediatric palliative care (PPC) and highlight the importance of a collaborative approach between oncologists and palliative care teams. This study investigates the impact of early versus late referral to PPC, intersecting it with the synergy work between services and the related outcomes. The four pediatric cancer cases were selected based on clinical (e.g., disease duration, multiple treatments, and pain management), management (e.g., involvement of multiple services and multiple home-hospital transitions), and relevance of multidisciplinary team (e.g., difficult clinical decisions and ethical discussions) criteria. A mixed-methods approach was employed, combining qualitative case analysis using clinical diaries, literature review, and practice guidelines development. Critical clinical information, time course, clinician-family communication, and patient involvement were analyzed. The outcomes show how simultaneous care creates continuous discussion and dialogue between professionals. The results indicate the importance of better communication and care coordination to improve patient and family satisfaction, highlighting the uniqueness of the pediatric field and the relationship with children and families. Through the discussion of clinical cases and a literature review, we provide practical guidance for clinicians working in oncology and PPC. These findings underscore the crucial need for a multidisciplinary approach in pediatric oncology, advocating policy changes to support early PPC integration and translate it into complementarity best operating practices. In conclusion, besides assessing the timeliness of referral to the PPC service, the synergy, harmony, and choral work of the professionals involved are equally valuable for a quality-of-life-oriented care plan.

A 15-year experience in pediatric palliative care: a retrospective hospital-based study.

BACKGROUND: The current Italian scenario of pediatric palliative care (PPC) services is characterized by inadequate coverage of the territory. Therefore, it is important to improve the referral of patients to the most appropriate setting (community care, general PPC, or specialized PPC) and to improve the delivery of PPC care. METHODS: Aiming at obtaining information about the referrals to the Padua Pediatric Hospice that could help estimate the investments needed to improve the provision of care, a retrospective analysis has been carried out. The rate of proper referral and discharge, the number of patients followed at the hospice, the mortality rate, and the length of follow-up were analyzed, and, when possible, data were stratified by oncological and non-oncological diseases. RESULTS: The analysis showed that of the 870 patients referred to the Padua Pediatric Hospice between 2008 and 2022, 76% were affected by non-oncological conditions. 82% of patients referred were taken in charge and most of the remaining patients have been inappropriately referred. The analysis showed a growing number of total referrals, which increased by 195% from 2008 to 2022. An increase in proper referrals and referrals of non-oncological patients was observed alongside a decrease in oncological patient referrals and a trend toward a decrease in discharge rates. A decreased mortality was observed in patients with non-oncological conditions, with only 6% of deceased patients in 2022. Moreover, a longer survival with a median follow-up length of 43 months was observed among patients with non-oncological conditions who were followed up at the Padua Pediatric Hospice for more than 12 months. Conversely, the short survival rate observed for oncological patients suggests that those patients should have been referred to PPC earlier to benefit from palliative care for longer periods. CONCLUSIONS: Considering these data, it is expected that the number of patients needing PPC services will steadily increase in the next years. Hence, there is a need to invest resources to provide the best care delivery model encompassing specific pathways for the transition into adulthood, the establishment of networks within all the Italian regions, and an efficient referral to the more suitable setting of care.

Polypharmacy in Children with Medical Complexity: A Cross-Sectional Study in a Pediatric Palliative Care Center.

BACKGROUND: Children with medical complexity (CMC) often require multiple medications, leading to polypharmacy, which seems to be linked to adverse effects, administration errors, and increased caregiver burden. This study aimed to describe the prevalence of polypharmacy, medication burden, off-label drug use, and associated costs. METHODS: Conducted at the Pediatric Palliative Care Center of Padua, Italy, from August to October 2021, this cross-sectional observational study included patients up to 23 years old with at least one prescribed drug. Data were collected from medical records and caregiver interviews. Drug costs were collected from the Italian Medicine Agency. Descriptive statistical analysis was performed. For comparisons among categorical variables, the Chi-square test was used, and for those among continuous variables, the ANOVA test was used. RESULTS: This study analyzed treatment regimens of 169 patients with a median age of 12.5 years (0.3-23). Polypharmacy was present in 52.7% of patients, and medication burden was observed in 44.4%, both varying significantly by primary diagnosis (p < 0.001). The median daily cost per patient was EUR 2.2 (IQR 0.9-7.1), with significant variation among subgroups. Only 34.6% of prescriptions were off-label. CONCLUSIONS: polypharmacy and medication burden are frequent among our CMC population, with some differences according to primary diagnosis.

International consensus on sleep problems in pediatric palliative care: Paving the way.

OBJECTIVE: Sleep problems constitute a common and heterogeneous complaint in pediatric palliative care (PPC), where they often contribute to disease morbidity and cause additional distress to children and adolescents and their families already facing the burden of life-threatening and life-limiting conditions. Despite the significant impact of sleep problems, clinical evidence is lacking. The application of general pediatric sleep recommendations appears insufficient to address the unique challenges of the PPC dimension in terms of disease variability, duration, comorbidities, complexity of needs, and particular features of sleep problems related to hospice care. Therefore, we initiated an international project aimed at establishing a multidisciplinary consensus. METHODS: A two-round Delphi approach was adopted to develop recommendations in the areas of Definition, Assessment/Monitoring, and Treatment. After selecting a panel of 72 worldwide experts, consensus (defined as ≥75% agreement) was reached through an online survey. RESULTS: At the end of the two voting sessions, we obtained 53 consensus recommendations based on expert opinion on sleep problems in PPC. CONCLUSIONS: This study addresses the need to personalize sleep medicine's approach to the palliative care setting and its peculiarities. It provides the first international consensus on sleep problems in PPC and highlight the urgent need for global guidance to improve sleep-related distress in this vulnerable population and their caregivers. Our findings represent a crucial milestone that will hopefully enable the development of guidelines in the near future.

The specialized pediatric palliative care service in Italy: how is it working? Results of the nationwide PalliPed study.

BACKGROUND: Accurate estimation of the specialized pediatric palliative care (PPC) burden and the definition of the extent and quality of PPC service in Italy represent urgent needs to enable the proper allocation of PPC resources and the definition of prevention and educational plans. The PalliPed project aimed to provide the first comprehensive assessment of the characteristics of Italian patients requiring PPC, the quality and extent of regional PPC networks/facilities, and the number of dedicated resources. In this paper, we present the results of the second part of the project, regarding the implementation and quality of PPC services in Italy. METHODS: The PalliPed study had an observational cross-sectional design. All Italian specialized PPC centers/facilities were invited to participate in the project and complete a survey on the characteristics of PPC centers/facilities in different care settings, reporting data as of 24 October 2022. Data were collected online. RESULTS: 19 PPC specialized centers/facilities from 12 Italian regions and two autonomous provinces responded to the survey. Among them, 11 are regional referral centers. Seven Italian regions out of 20 reported no PPC centers/facilities, mainly in central-southern Italy. Less than half (45%) of the regional referral centers cover the entire regional territory, and three offer 24/7 service. Ten centers have a dedicated team. Half of the eight non-referral centers offer 24/7 service and have a dedicated team. A total of 1,092 patients were reported by 18 centers as of 24 October 2022. Over the years, an increasing number of patients has been reported, rising from 1,202 (2019) to 1,544 (2021). The dedicated staff is inadequate, and most healthcare providers are not recognized at an institutional level. A shortage of 'young' staff and a lack of specific training was reported, particularly among nurses (77% had no training in PPC). CONCLUSIONS: The results obtained show how training, information, and research interventions are still necessary for the reorganization of the available resources and definition of proper strategies to respond dynamically to the new emerging needs of these populations. At the same time, our study represents a first step in defining a national registry of PPC models, useful for monitoring evolutions, and critical issues and planning any new or corrective strategy.

Unravelling the role of mind-body therapies in paediatric palliative care: A narrative review.

AIM: Given the multifaceted nature of paediatric palliative care (PPC), integrative medicine and mind-body therapies, in particular, are increasingly used in this setting. However, to our knowledge, their use in PPC has never been specifically reviewed. Therefore, this work aims to provide a comprehensive overview of the application and possible beneficial effects of mind-body therapies in the PPC setting. METHODS: Papers about the use of meditation and mindfulness, biofeedback, hypnosis, yoga, tai chi and qi gong, imagery, creative outlets, and art therapy in PPC were identified by browsing PubMed and CINHAL. RESULTS: We found that the harmless nature of mind-body therapies has been extensively described, and available studies consistently show some benefits on the anxiety, stress, and quality of life of parents/caregivers and healthcare providers. However, well-grounded and robust evidence does not fully support the efficacy of mind-body therapies, especially in patients. CONCLUSION: Considering the peculiarity of the PPC setting, we suggest that mind-body therapies should be further considered and properly investigated through larger controlled studies and according to the different populations of PPC children, as well as for parents, caregivers, and healthcare professionals.

A pilot study on sports activities in pediatric palliative care: just do it.

BACKGROUND: There has been a growing interest in studying the value of physical exercise in children with disabilities or chronic health conditions because of evidence of improvement in quality of life, social acceptance, and physical functioning. However, only scant evidence exists for routine sports activities in children requiring pediatric palliative care (PPC), and in most cases, such evidence has been collected in oncological patients. The Pediatric Hospice of Padua is the referral center for PPC in the Veneto region (northern Italy). Starting from the experience of this PPC center, this pilot study aims to describe the personal experience of children and young people who practice physical activity and their caregivers' perspectives, focusing particularly on the emotional and social impact of exercise and sports practice. METHODS: Patients involved in at least one regular and structured sports activity were included in the pilot analysis. Two different ICF-CY (International Classification of Functioning, Disability and Health-Children and Youth Version) scales ("Body Function" and "Activity and Participation") were filled out to assess the children's global functional competence. Two online ad hoc questionnaires were created and administered to children, when able to respond, and caregivers. RESULTS: A total of 9% of patients reported being involved in a sports activity. All children who played sports did not have indications of cognitive retardation. The most practiced sport was swimming. The use of standardized methods such as ICF-CY shown that severe motor impairments do not limit sports accessibility. Questionnaires result suggest that sports are a positive experience for both children needing PPC and their parents. Children encourage other children to do sports and can find the positive side even in difficulties. CONCLUSION: Since PPC is encouraged as early as the diagnosis of incurable pathologies, the inclusion of sports activities in the context of a PPC plan should be considered from the perspective of improving quality of life.

Pediatric Palliative Care in Oncology: Basic Principles.

About 4 million children with an oncological disease worldwide require pediatric palliative care (PPC) due to the nature of their condition. PPC is not limited to end-of-life care; it is a general approach continuing over the entire disease trajectory, regardless of whether the patient receives any oncological treatment. This review addresses the value of integrating PPC in treating children with cancer, focusing on the basic principles of PPC and its application in pediatric oncology. Moreover, models for PPC implementation in oncology, end-of-life care, and advanced care planning are discussed.

International Standards for Pediatric Palliative Care: From IMPaCCT to GO-PPaCS.

CONTEXT: Since the publication of the IMPaCCT project in 2007, much effort has been made to develop new approaches to pediatric palliative care (PPC). Fifteen years later, it is time to redefine the standards in PPC. OBJECTIVES: An international group of experts in PPC has revised the standards in PPC through the GO-PPaCS project (Global Overview - PPC Standards). The goal was to update the PPC standards considering the specificity of different settings, resources, and emerging challenges. The present document is intended to reach all people directly or indirectly involved in PPC. METHODS: A literature review in MEDLINE was conducted to expand on the fundamental points and current standards on PPC and to cover an international setting. The literature search (updated on the 15th of April 2021) was carried out using different combinations of keywords and focusing on papers published in English over the past 5 years (2016-2020), but older articles were considered when relevant. The consensus on the fundamental points, standards of care and paper contents was reached by open discussion. RESULTS: Fundamental points were defined regarding the definition of PPC, eligibility criteria and the magnitude of the need for PPC, while standards were redefined for the following six areas: 1) clinical, developmental, psychological, social, ethical and spiritual needs; 2) end-of-life care; 3) care models and settings of care; 4) PPC in humanitarian emergencies; 5) care tools; and 6) education and training for healthcare providers. CONCLUSION: The present document, developed with the contribution of an international group of experts from different countries, experiences and models of care, provides fundamental points and standards for a wider implementation of PPC worldwide.

The use of medical cannabis in pediatric palliative care: a case series.

BACKGROUND: Medical cannabis may be a useful tool for managing treatment-resistant epilepsy and chronic pain, which affect many patients in pediatric palliative care (PPC); however, little evidence is available in this setting. CASE PRESENTATION: We aimed to describe a clinical experience in a setting where high-level evidence may not be obtained. We report our clinical experience in a pediatric palliative care department in Italy. Caregivers reported changes in intensity and frequency of pain and epilepsy events. Six patients received a titrated plant extract of cannabis sativa for 1 year. Only mild and transient adverse events occurred: drowsiness, euphoria, restlessness and tachycardia; the resolution was either spontaneous or obtained by modifying the administration schedule. Treatment was never discontinued. No overdoses occurred. All patients experienced seizures during the pre-treatment observation period, and obtained a reduction in seizure frequency, although with variable extent while receiving cannabis. In addition, a benefit on pain was observed, based on the caregiver's evaluation, and a reduction of analgesic use. CONCLUSION: Our experience suggests that a titrated plant extract preparation of medical cannabis may be useful to control treatment-resistant pain and epilepsy in PPC patients.

An estimation of the number of children requiring pediatric palliative care in Italy.

BACKGROUND: Pediatric palliative care (PPC) addresses the physical and psychological needs of children suffering from life-limiting diseases. To define prevention and educational plans and to properly allocate resources, a precise estimation of the PPC burden is required. OBJECTIVES: To estimate the current number of children requiring PPC in Italy, useful to assist policy-makers and healthcare bodies in the organization and allocation of PPC resources. METHODS: Literature data, The Global Atlas of Palliative Care at the End of Life and Italian national databases have been consulted. RESULTS: According to our estimation, at present, a total of 20,540-32,864 children in Italy require PPC (34-54 children/100,000 inhabitants) of whom 18 children/100,000 inhabitants require specialized PPC. CONCLUSIONS: The present work is a fundamental tool to be used by the institutions, the local networks of PPC and the health programmers when formulating organizational models and care plans consistent with the actual need for PPC.

COVID-19 in pediatric palliative care: what can we learn from the pandemic and possible future directions.

INTRODUCTION: Patients in pediatric palliative care (PPC) live with multiple comorbidities which represent a risk factor for severe form of COVID-19. METHODS: This monocentric retrospective study was performed at the PPC Center of Padua (Italy). Testing methodology, prevention strategies and infection characteristics were documented and compared during the first and second peak of SARS-CoV-2 infection. RESULTS: Between April-June 2020 a population swab screening was performed and a strong reduction of the habitual family support was observed. Between November 2020-January 2021 swab testing was limited to specific cases and the support network for families was partially restored. Incidence of COVID-19 was low, resulting in 0.04% of total pediatic cases in the Veneto Region. No severe forms were observed. CONCLUSION: The use of adequate preventive measures by families and support networks associated with testing in specific contests is safe, cost effective and has a minor impact on caregiver's care load.

A Tool for the Evaluation of Clinical Needs and Eligibility to Pediatric Palliative Care: The Validation of the ACCAPED Scale.

Background: Despite their importance, pediatric palliative care (PPC) services are still scantly diffused. In addition, eligibility criteria for PPC are quite complex. Consequently, clinicians require a tool that suggests how to refer patients with life-limiting diseases to the most appropriate service and how to properly allocate health care resources. Objective: Recently, the Accertamento dei bisogni Clinico-Assistenziali Complessi in PEDiatria (ACCAPED) scale has been developed by a group of experts in PPC to evaluate the specific clinical needs of pediatric patients with a life-limiting disease. This study presents the validation of the ACCAPED scale. Design: Validation of ACCAPED scale was pursued by means of description and analysis of clinical vignettes representing patients with challenging-to-evaluate needs who have to be referred to the most appropriate service (community care, general PPC, and specialized PPC). The evaluation of vignettes according to the clinical experience of the experts represented the gold standard against which the validity of the ACCAPED scale was tested by groups with different levels of experience (experts, pediatricians, and health care providers (HCPs) not involved in PPC). Results: Results show a very high concordance between the evaluation of the vignettes through the ACCAPED scale and the evaluation by the clinical experience for experts in PPC and pediatricians. A less favorable grade of concordance has been recorded for HCPs not involved in PPC, suggesting that educational efforts to improve basic knowledge of PPC within the medical community are needed. Conclusions: Overall, this study suggests that the ACCAPED scale is a useful tool to improve rationalization of resources and eligibility criteria for PPC.

Perinatal palliative care: a dedicated care pathway.

OBJECTIVE: Ensure access to perinatal palliative care (PnPC) to all eligible fetuses/infants/parents. DESIGN: During 12 meetings in 2016, a multidisciplinary work-group (WG) performed literature review (Grading of Recommendations, Assessment, Development and Evaluation (GRADE) method was applied), including the ethical and legal references, in order to propose shared care pathway. SETTING: Maternal-Infant Department of Padua's University Hospital. PATIENTS: PnPC eligible population has been divided into three main groups: extremely preterm newborns (first group), newborns with prenatal/postnatal diagnosis of life-limiting and/or life-threatening disease and poor prognosis (second group) and newborns for whom a shift to PnPC is appropriate after the initial intensive care (third group). INTERVENTIONS: The multidisciplinary WG has shared care pathway for these three groups and defined roles and responsibilities. MAIN OUTCOME MEASURES: Prenatal and postnatal management, symptom's treatment, end-of-life care. RESULTS: The best care setting and the best practice for PnPC have been defined, as well as the indications for family support, corpse management and postmortem counselling, as well suggestion for conflicts' mediation. CONCLUSIONS: PnPC represents an emerging field within the paediatric palliative care and calls for the development of dedicated shared pathways, in order to ensure accessibility and quality of care to this specific population of newborns.