How to conduct research in palliative care? A perspective from Italy.

BACKGROUND: In western countries, the increasing life expectancy and the growing number of individuals with advanced chronic conditions have resulted in a greater demand for palliative care. Specifically, Italy has witnessed substantial growth in the palliative care field, marked by the establishment of Palliative Care Networks and an academic fellowship program in 2022. To further enhance this field, it is crucial to conduct high-quality scientific research that produces results applicable in clinical practice. AIM: This article explores challenges and potential solutions in conducting effective palliative care research, considering sample definition, research settings, outcomes, and ethical concerns. While focusing on the Italian context, the presented research framework can be applied to other contexts and regions. RESULTS: Palliative care research is complex and challenging due to its holistic approach, which encompasses various vital dimensions of patients and their families, including physical, emotional, and social needs. The Italian and worldwide experience provides insights into managing these challenges and enhancing the methodological rigor of studies and the practical application of research findings. CONCLUSIONS: This article emphasizes the importance of developing protocols tailored to palliative care's unique characteristics, and the necessity of dedicated funding for palliative care research, calling for increased support and recognition. The article advocates for improvement of the quality and relevance of palliative care studies, promoting better patient outcomes and enhanced caregiving.

Causes of deaths in long-term care and hospice care facilities during the first year of COVID-19 pandemic: a snapshot of Italy during 2020.

BACKGROUND: Older adults living in long-term care facilities (LTCF) have been severely affected by COVID-19. Hospice care (HC) facilities and palliative care are essential in treating patients dying from COVID-19. In Italy, little is known about the impact of COVID-19 on deaths in LTCF and the care provided in HC to COVID-19 patients. AIM: To assess overall and case-specific mortality in 2020 in LTC and HC facilities in comparison to the previous five years (2015-2019). METHODS: We performed a descriptive study using data derived from the Italian national "Cause of Death" registry-managed by the Italian National Institute of Statistics-on deaths occurred in LTC and HC facilities during 2020 and the period 2015-2019. RESULTS: Number of deaths significantly increased in 2020 compared with 2015-2019 in LTCF (83,062 deaths vs. 59,200) and slightly decreased in hospices (38,788 vs. 39,652). COVID-19 caused 12.5% of deaths in LTCF and only 2% in hospices. Other than COVID-19, in 2020, cancer accounted for 77% of all deaths that occurred in HC, while cardiovascular diseases (35.6%) and psychotic and behavioral disorders (10%) were the most common causes of death in LTCF. Overall, 22% of the excess mortality registered in Italy during 2020 is represented by the deaths that occurred in LTCF. DISCUSSION AND CONCLUSION: LTCF were disproportionally affected by COVID-19, while the response to the pandemic in HC was limited. These data can help plan strategies to limit the impact of future epidemics and to better understand residential care response to COVID-19 epidemic.

Aberrant opioid use behaviour in advanced cancer.

OBJECTIVES: To evaluate the presence of aberrant behaviour in a consecutive sample of patients with advanced cancer treated with opioids in a country like Italy, with its peculiar attitudes towards the use opioids. The second objective was to detect the real misuse of opioids in clinical practice. METHODS: Prospective observational study in two palliative care units in Italy in a period of 6 months. At admission the Edmonton Symptom Assessment Scale, the Memorial Delirium Assessment Scale, Brief Pain Inventory (BPI) and the Hospital Anxiety Depression Scale were measured. For detecting the risk of aberrant opioid use, the Screener and Opioid Assessment for Patients With Pain (SOAAP), the Opioid Risk Tool (ORT), the Cut Down-Annoyed-Guilty-Eye Opener (CAGE) questionnaire adapted to include drug use (CAGE-AID) were used. Aberrant behaviours displayed at follow-up within 1 month were recorded. RESULTS: One-hundred and thirteen patients with advanced cancer were examined. About 35% of patients were SOAPP positive. There was correlation between SOAPP, CAGE-AID and ORT. SOAPP was independently associated with a lower Karnofsky level, pain intensity, poor well-being, BPI pain at the moment. No patient displayed aberrant behaviours, despite having a moderate-high risk. CONCLUSIONS: Despite a high percentage of patients showed a high risk of aberrant behaviours, no patient displayed clinical aberrant behaviours after 1 month-follow-up. This does not exempt from continuous monitoring for patients who are at risk.

Barriers and Adherence to Pain Management in Advanced Cancer Patients.

AIM: To assess patients' barriers to pain management and analgesic medication adherence in patients with advanced cancer. METHODS: This was a prospective cross-sectional study in patients with advanced cancer receiving chronic opioid therapy. Age, gender, cancer diagnosis, Karnofsky level, and educational status were recorded. The Brief Pain Inventory (BPI), Edmonton Symptom Assessment Scale (ESAS), Memorial Delirium Assessment Scale (MDAS), Barriers Questionnaire II (BQ-II), Medication Adherence Rating Scale (MARS), and Hospital Anxiety and Depression Scale (HADS) were the measurement instruments used. RESULTS: One-hundred-thirteen patients were analyzed. The mean age was 68 (±13) years, and 59 (52%) were male. The mean Karnofsky status was 51.4 (standard deviation [SD] 11.5). The mean score for BQ-II items was 1.77 (SD 0.7). The BQ-II score was independently related to the HADS-Depression score (P = 0.033) and the total HADS score (P = 0.049). Negative side-effects and attitudes toward psychotropic medication globally prevailed among MARS items. These items were independently associated with gender (P = 0.030), pain (P = 0.003), and depression (P = 0.047). CONCLUSION: Barriers to pain management were mild. Psychological factors such as depression were the main factor associated with barriers. Poor adherence to analgesic medication was mostly manifested as negative side-effects and attitudes toward psychotropic medication, was more frequent observed in females, and was associated with the ESAS items pain and depression.

[Palliative care in the cardiac setting: a consensus document of the Italian Society of Cardiology/Italian Society of Palliative Care (SIC/SICP)]. / Documento di consenso sulle cure palliative in ambito cardiologico a cura del Gruppo di Lavoro congiunto della Società Italiana di Cardiologia (SIC) e della Società Italiana di Cure Palliative (SICP).

Palliative care is recognized as an approach that improves quality of life of patients and families facing life-threatening illnesses. This is achieved through prevention, early identification, assessment and treatment of symptoms and other psycho-social, spiritual and economic issues. Palliative care is not dependent on prognosis and can be delivered as "simultaneous care", together with disease-modifying treatments and adequate symptom relief. Palliative care relies on coordination across settings of care and offers open communication to patients and caregivers. Recently, there is increasing interest in the potential role of palliative care in refractory, advanced heart failure treated with optimal, maximized therapy.Heart failure is a chronic progressive syndrome characterized by periods of stability interrupted by acute exacerbations, usually leading to reduced functional status. It accounts for approximately one-third of deaths in industrialized countries and is a common cause of hospitalization. Fifty percent of patients with advanced heart failure die within 1 year of diagnosis and 50% of the remainder within 5 years. The trajectory of heart failure is often unpredictable and approximately 30% to 50% of patients die suddenly. Patients with heart failure suffer from numerous symptoms, often resistant to conventional treatments, frequently under-recognized and under-treated. Symptom assessment and control improve quality of life in patients with advanced heart failure; this can be managed at best by collaboration between specialistic teams.Although heart failure is a life-shortening condition, therapeutic and technological advances (such as left ventricular assist devices, coronary revascularization, percutaneous valve implantation, and implantable cardioverter defibrillators) can help healthcare professionals in the management of patients with advanced heart failure, improving global condition and reducing the risk of sudden death. On the other hand, it has to be acknowledged that management of cardiovascular implanted electronic devices towards end of life requires awareness of legal, ethical, religious principles regarding potential withdrawal of life-sustaining therapies.Adequate communication with patients regarding adverse events, end of life, benefits vs burdens of therapies and interventions, treatment preferences, and decision-making should be an issue in early stages of disease. The process of advanced care planning should be clearly documented and regularly reviewed.Barriers to the provision of palliative care in heart failure include clinical issues (disease trajectory), prognostic uncertainty, failure in identification of patients who need palliative care and timing of referral to specialist services, but also misconceptions of patients, families and sanitary staff regarding the role of palliative care, organization problems, and finally educational and time issues.This document focuses on the need of further, coordinated research and work-out on: (i) identification of heart failure patients eligible for palliative care, in terms of clinical and social-psychological issues, (ii) identification of trigger events and timing of referral; (iii) identification of adequate performance indicators/scales for measurement, assessment and follow-up of symptoms and quality of life in end-stage heart failure, including patient-reported outcome measures; (iv) treatment, care and organization strategies and models for advanced/end-stage heart failure ("care management"); and (v) implementation of knowledge and education of healthcare professionals in the fields of communication, ethics, and advanced care planning in heart failure.

Delirium, Dementia, and In-Hospital Mortality: The Results From the Italian Delirium Day 2016, A National Multicenter Study.

BACKGROUND: There is little evidence about the prevalence of cognitive disorders and their effect on in-hospital mortality in large multicenter studies. The objectives of the 2016th edition of the "Italian Delirium Day," a large multicenter study on in-hospital older patients, were to assess (i) the point prevalence of cognitive impairment/no dementia, dementia, delirium, and delirium superimposed on dementia and (ii) the effect of these conditions on in-hospital mortality. METHODS: This multicenter study and included 2,037 older patients (aged ≥65 years) admitted to acute medical and surgical wards across 205 acute hospitals. The four cognitive disorders groups were defined with a structured approach including the four AT and the presence of a documented diagnosis of dementia. The outcome measure was in-hospital mortality, as reported by the researchers involved in the study in each center. RESULTS: The mean age was 81.17 ± 7.7 years. Overall, 893 patients (43.8%) had neither delirium nor dementia nor cognitive impairment, 483 (23.7%) had cognitive impairment/no dementia, 230 (11.3%) dementia alone, 187 (9.2%) delirium alone, and 244 (12.0%) delirium superimposed on dementia. Overall, 99 (4.8%) patients died. Participants with delirium alone (odds ratio 2.56; 95% confidence interval: 1.29-5.09) and those with delirium superimposed on dementia (odds ratio 2.60; 95% confidence interval: 1.39-4.85) had higher mortality risk compared with the reference group of patients with "no cognitive impairment." CONCLUSIONS: Delirium and delirium superimposed on dementia were highly prevalent among older hospitalized patients and significantly increased in-hospital mortality. Clinicians should systematically assess these conditions and recognize them as markers of critical conditions and predictors of imminent death.

Spirituality and Awareness of Diagnoses in Terminally Ill Patients With Cancer.

OBJECTIVE: Aims of the present study were to investigate the association between awareness of own illness condition and psychological outcome in end-of-life phase and to test the association between the spirituality and the awareness of own illness condition. METHODS: Three hundred and ninety-nine terminally ill patients with cancer were enrolled in a hospice in central Italy. One hundred patients satisfied the inclusion criteria. The Systems of Belief Inventory, the Hospital Anxiety and Depression Scale, and a psychological interview to determine the level of awareness of the illness diagnosis (aware; partially aware; and not aware) were administered to terminally ill patients. RESULTS: The main finding was that the awareness of one's own illness condition was positively associated with the extrinsic spirituality and negatively associated with intrinsic spirituality (regression model R = .26; R2 = .07; adjusted R2 = .05; F2, 97 = 3.45; P = .036). The aware group showed lower anxiety and depression ( F2, 97 = 1.9; P = . 075; F2, 97 = 2.6; P = .04) scores than partially aware and not aware groups. The psychological outcome was not associated with the spirituality level. CONCLUSION: In terminally ill patients with cancer, the levels of depression and anxiety were lower in patients aware of their own illness state. Moreover, higher levels of extrinsic and lower levels of intrinsic spirituality predicted the awareness of one's own illness state.

Persistent complex bereavement disorder in caregivers of terminally ill patients undergoing supportive-expressive treatment: a pilot study.

BACKGROUND: The proposal of persistent complex bereavement disorder (PCBD) in the DSM-V increased the interest on the impact of grief on the psychological health. AIMS: Investigating the time course of psychological symptoms, emotional and social abilities in caregivers (undergoing or not to supportive-expressive treatment) of terminally ill cancer patients from 1 months before loss to 14 months after it. METHOD: Thirty-three of 60 caregivers were assessed by PG-12, HAM-A, HAM-D, TAS-20 and ASQ, at the admission in Hospice, and after 3, 10 and 14 months from the loss. Twelve caregivers adhered to follow a supportive-expressive treatment and 21 caregivers did not. RESULTS: PG-12, anxiety, and depression scores decreased in both groups over time. The score of difficulty in identifying emotions and confidence with closeness decreased significantly only in the treated-group. PG-12 score at T0 was able to predict the DSM V diagnosis of PCBD at T3. CONCLUSIONS: Findings showed a decrease of the anxiety, depression, security in the attachment style and an increase of the ability to identify emotions during the first year after loss in caregivers of terminally ill cancer patients. Pre-loss assessment of prolonged grief risk seems useful to predict the diagnosis of PCBD 1 year after loss.

Attachment style dimensions can affect prolonged grief risk in caregivers of terminally ill patients with cancer.

OBJECTIVE: The aim of the present study was to evaluate the predictive role of attachment dimensions on the risk of prolonged grief. Sixty caregivers of 51 terminally ill patients with cancer who had been admitted in a hospice were selected. METHODS: Caregivers were interviewed using Attachment Scale Questionnaire, Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, and Prolonged Grief Disorder 12 (PG-12). RESULTS: The consort caregivers showed higher PG-12 level compared to the sibling caregivers. Anxiety, depression, need for approval, and preoccupation with relationships levels were significantly correlated with PG-12 scores. CONCLUSION: Female gender, high levels of depression, and preoccupation with relationships significantly predicted higher levels of prolonged grief risk.

[Bereavement and complicated grief: towards a definition of Prolonged Grief Disorder for DSM-5]. / Eventi di perdita e lutto complicato: verso una definizione di disturbo da sofferenza prolungata per il DSM-5.

Mourning is a natural response to a loss and a condition which most people experience several times during their lives. Most individuals adjust adequately to the loss of a relative, neverthless, a small but noteworthy proportion of bereaved individuals experience a syndrome of prolonged psychological distress in relation to bereavement. Prolonged distress and disability in connection with bereavement has been termed Complicated Grief (CG) or Prolonged Grief Disorder (PGD). The purpose of this paper is to analyze the literature on loss and mourning making a review of the main studies published between 1993 and 2013, identified through a search conducted on Medline/PubMed, in order to describe the epidemiological and clinical aspects of "normal" grief and "complicated" grief, pointing out the path of the clinical definition of PGD and proposed diagnostic criteria for inclusion in the next edition of the Diagnostic and Statistic Manual of Mental Disorders, Fifth edition (DSM-5). The two main diagnostic systems proposed by Horowitz and Prigerson are also compared.

Predictive role of different dimensions of burden for risk of complicated grief in caregivers of terminally ill patients.

The aim of the study was to test whether high levels of caregiver burden, as other confirmed predictors, are associated with the risk of prolonged grief disorder in caregivers of terminally ill patients. A predictive study was carried out in order to test the hypothesis. A demographic schedule, the Prolonged Grief 12 (PG-12), the Toronto Alexithymia Scale, Hamilton Anxiety Rating Scale, Hamilton Depression Rating Scale, and Caregiver Burden Inventory were administered to 60 caregivers of 51 patients who were admitted in Hospice. In the regression analysis, difficulty in recognizing emotions, total burden, depression, and developmental burden dimension were significant predictors of PG-12 levels. Findings showed that feeling of deprivation of existential expectations represents the greater risk factor for the prolonged grief disorder, among the burden dimensions.