The effectiveness and cost-effectiveness of hospital-based specialist palliative care for adults with advanced illness and their caregivers.

BACKGROUND: Serious illness is often characterised by physical/psychological problems, family support needs, and high healthcare resource use. Hospital-based specialist palliative care (HSPC) has developed to assist in better meeting the needs of patients and their families and potentially reducing hospital care expenditure. There is a need for clarity on the effectiveness and optimal models of HSPC, given that most people still die in hospital and also to allocate scarce resources judiciously. OBJECTIVES: To assess the effectiveness and cost-effectiveness of HSPC compared to usual care for adults with advanced illness (hereafter patients) and their unpaid caregivers/families. SEARCH METHODS: We searched CENTRAL, CDSR, DARE and HTA database via the Cochrane Library; MEDLINE; Embase; CINAHL; PsycINFO; CareSearch; National Health Service Economic Evaluation Database (NHS EED) and two trial registers to August 2019, together with checking of reference lists and relevant systematic reviews, citation searching and contact with experts to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) evaluating the impact of HSPC on outcomes for patients or their unpaid caregivers/families, or both. HSPC was defined as specialist palliative care delivered by a palliative care team that is based in a hospital providing holistic care, co-ordination by a multidisciplinary team, and collaboration between HSPC providers and generalists. HSPC was provided to patients while they were admitted as inpatients to acute care hospitals, outpatients or patients receiving care from hospital outreach teams at home. The comparator was usual care, defined as inpatient or outpatient hospital care without specialist palliative care input at the point of entry into the study, community care or hospice care provided outside of the hospital setting. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. We assessed risk of bias and extracted data. To account for use of different scales across studies, we calculated standardised mean differences (SMDs) with 95% confidence intervals (CIs) for continuous data. We used an inverse variance random-effects model. For binary data, we calculated odds ratio (ORs) with 95% CIs. We assessed the evidence using GRADE and created a 'Summary of findings' table. Our primary outcomes were patient health-related quality of life (HRQoL) and symptom burden (a collection of two or more symptoms). Key secondary outcomes were pain, depression, satisfaction with care, achieving preferred place of death, mortality/survival, unpaid caregiver burden, and cost-effectiveness. Qualitative data was analysed where available. MAIN RESULTS: We identified 42 RCTs involving 7779 participants (6678 patients and 1101 caregivers/family members). Twenty-one studies were with cancer populations, 14 were with non-cancer populations (of which six were with heart failure patients), and seven with mixed cancer and non-cancer populations (mixed diagnoses). HSPC was offered in different ways and included the following models: ward-based, inpatient consult, outpatient, hospital-at-home or hospital outreach, and service provision across multiple settings which included hospital. For our main analyses, we pooled data from studies reporting adjusted endpoint values. Forty studies had a high risk of bias in at least one domain. Compared with usual care, HSPC improved patient HRQoL with a small effect size of 0.26 SMD over usual care (95% CI 0.15 to 0.37; I2 = 3%, 10 studies, 1344 participants, low-quality evidence, higher scores indicate better patient HRQoL). HSPC also improved other person-centred outcomes. It reduced patient symptom burden with a small effect size of -0.26 SMD over usual care (95% CI -0.41 to -0.12; I2 = 0%, 6 studies, 761 participants, very low-quality evidence, lower scores indicate lower symptom burden). HSPC improved patient satisfaction with care with a small effect size of 0.36 SMD over usual care (95% CI 0.41 to 0.57; I2 = 0%, 2 studies, 337 participants, low-quality evidence, higher scores indicate better patient satisfaction with care). Using home death as a proxy measure for achieving patient's preferred place of death, patients were more likely to die at home with HSPC compared to usual care (OR 1.63, 95% CI 1.23 to 2.16; I2 = 0%, 7 studies, 861 participants, low-quality evidence). Data on pain (4 studies, 525 participants) showed no evidence of a difference between HSPC and usual care (SMD -0.16, 95% CI -0.33 to 0.01; I2 = 0%, very low-quality evidence). Eight studies (N = 1252 participants) reported on adverse events and very low-quality evidence did not demonstrate an effect of HSPC on serious harms. Two studies (170 participants) presented data on caregiver burden and both found no evidence of effect of HSPC (very low-quality evidence). We included 13 economic studies (2103 participants). Overall, the evidence on cost-effectiveness of HSPC compared to usual care was inconsistent among the four full economic studies. Other studies that used only partial economic analysis and those that presented more limited resource use and cost information also had inconsistent results (very low-quality evidence). Quality of the evidence The quality of the evidence assessed using GRADE was very low to low, downgraded due to a high risk of bias, inconsistency and imprecision. AUTHORS' CONCLUSIONS: Very low- to low-quality evidence suggests that when compared to usual care, HSPC may offer small benefits for several person-centred outcomes including patient HRQoL, symptom burden and patient satisfaction with care, while also increasing the chances of patients dying in their preferred place (measured by home death). While we found no evidence that HSPC causes serious harms, the evidence was insufficient to draw strong conclusions. Although these are only small effect sizes, they may be clinically relevant at an advanced stage of disease with limited prognosis, and are person-centred outcomes important to many patients and families. More well conducted studies are needed to study populations with non-malignant diseases and mixed diagnoses, ward-based models of HSPC, 24 hours access (out-of-hours care) as part of HSPC, pain, achieving patient preferred place of care, patient satisfaction with care, caregiver outcomes (satisfaction with care, burden, depression, anxiety, grief, quality of life), and cost-effectiveness of HSPC. In addition, research is needed to provide validated person-centred outcomes to be used across studies and populations.

The assessment of spiritual well-being in cancer patients with advanced disease: which are its meaningful dimensions?

BACKGROUND: Spirituality is particularly important for patients suffering from life-threatening illness. Despite research showing the benefits of spiritual assessment and care for terminally ill patients, their spiritual needs are rarely addressed in clinical practice. This study examined the factor structure and reliability of the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp) in patients with advanced cancer. It also examined the clinical meaning and reference intervals of FACIT-Sp scores in cancer patients subgroups through a literature review. METHODS: A forward-backward translation procedure was adopted to develop the Italian version of the FACIT-Sp, which was administered to 150 terminally ill cancer patients. Exploratory factor analysis was used for construct validity, while Cronbach's α was used to assess the reliability of the scale. RESULTS: This study replicates previous findings indicating that the FACIT-Sp distinguish well between features of meaning, peace, and faith. In addition, the internal consistency of the FACIT-Sp was acceptable. The literature review also showed that terminal cancer patients have the lowest scores on the Faith and Meaning subscales, whereas cancer survivors have the highest scores on Faith. CONCLUSIONS: The Italian version of the FACIT-Sp has good construct validity and acceptable reliability. Therefore, it can be used as a tool to assess spiritual well-being in Italian terminally ill cancer patients. This study provides reference intervals of FACIT-Sp scores in newly diagnosed cancer patients, cancer survivors, and terminally ill cancer patients and further highlights the clinical meaning of such detailed assessment.

Palliative care training addressed to hospital healthcare professionals by palliative care specialists: a mixed-method evaluation.

BACKGROUND: Despite the great advances in the concept of palliative care (PC) and its benefits, its application seems to be delayed, leaving unfulfilled the many needs of patients and family members. One way to overcome this difficulty could be to develop a new training programme by palliative care specialists to improve PC primary skills in healthcare professionals. The aim of this study was to evaluate the training's impact on trainees within a hospital setting using Kirkpatrick's and Moore's models. METHODS: We adopted a mixed-method evaluation with concurrent triangulation. The evaluation followed the first three steps of Kirkpatrick's and Moore's models and included a pre- and post-training evaluation through self-administered questionnaires and focus groups. We used the McNemar statistical test. RESULTS: The results highlighted the significant amount of knowledge acquired by the hospital professionals after training, in terms of increasing their knowledge of palliative care and in terms of the change in meaning that they attributed to phenomena related to chronicity and incurability, which they encounter daily in their professional practice. In both quantitative and qualitative research, the results, in synthesis, highlight: (i) the development of a new concept of palliative care, centred on the response to the holistic needs of people; (ii) that palliative care can also be extended to non-oncological patients in advanced illness stages (our training was directed to Geriatrics and Nephrology/Dialysis professionals); (iii) the empowerment and the increase in self-esteem that healthcare professionals gained, from learning about the logistical and structural organization of palliative care, to activate and implement PC; (iv) the need to share personal aspects of their professional life (this result emerges only in qualitative research); (v) the appreciation of cooperation and the joining of multiple competences towards a synergistic approach and enhanced outcomes. CONCLUSION: It is necessary to further develop rigorous research on training evaluation, at the most complex orders of the Kirkpatrick and Moore models, to measure primary PC skills in health care professionals. This will develop the effectiveness of the integration of I- and II-level palliative care competencies in hospitals and improve outcomes of patients' and families' quality of life.

Comprehensive and Integrated Palliative Care for People With Advanced Chronic Conditions: An Update From Several European Initiatives and Recommendations for Policy.

The number of people in their last years of life with advanced chronic conditions, palliative care needs, and limited life prognosis due to different causes including multi-morbidity, organ failure, frailty, dementia, and cancer is rising. Such people represent more than 1% of the population. They are present in all care settings, cause around 75% of mortality, and may account for up to one-third of total national health system spend. The response to their needs is usually late and largely based around institutional palliative care focused on cancer. There is a great need to identify these patients and integrate an early palliative approach according to their individual needs in all settings, as suggested by the World Health Organization. Several tools have recently been developed in different European regions to identify patients with chronic conditions who might benefit from palliative care. Similarly, several models of integrated palliative care have been developed, some with a public health approach to promote access to all in need. We describe the characteristics of these initiatives and suggest how to develop a comprehensive and integrated palliative approach in primary and hospital care and to design public health and community-oriented practices to assess and respond to the needs in the whole population. Additionally, we report ethical challenges and prognostic issues raised and emphasize the need for research to test the various tools and models to generate evidence about the benefits of these approaches to patients, their families, and to the health system.

The experience of accreditation of the Reggio Emilia Research Hospital with the OECI model.

The research hospital Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) of Reggio Emilia has a unique organization that involves a recently recognized IRCCS in oncology within a preexisting general hospital. The IRCCS of Reggio Emilia joined the "Tailored Accreditation Model for Comprehensive Cancer Centers: Validation through the Applicability of the Experimental OECI-based Model to the Network of Cancer IRCCS of the Alliance Against Cancer" and applied the accreditation & designation (A&D) Organisation of European Cancer Institutes (OECI) model in 2013. Before that accreditation, it had never been accredited according to international accreditation systems concerning cancer. By December 2015, the IRCCS of Reggio Emilia completed the first steps of the A&D OECI process (self-assessment period, peer review visit, implementation of the improvement plan). In December 2014, OECI confirmed the accreditation of our IRCCS and its designation as a Clinical Cancer Center and proposed a revisit at 2 years for upgrading the designation to Comprehensive Cancer Center (CCC). On the whole, the results given by adhesion to the A&D-OECI project are numerous and positive, under different points of view, formal (European accreditation and designation as a Clinical Cancer Center with possible upgrade to CCC) and substantial (involvement of professionals, attention to ongoing improvement, work on the sectors mainly of interest). The balance between the advantages and disadvantages linked to this accreditation model was positive. Following our experience, we conclude that the model was useful also for our kind of IRCCS, with its features useful for investigating all the sectors of the patient care pathway and research and necessity to stimulate change.

An unconventional cancer treatment lacking clinical efficacy remains available to Italian cancer patients.

AIMS AND BACKGROUND: An unconventional cancer treatment known as "Di Bella multitherapy" gained popularity among Italian cancer patients during the 90's. In 1999, it was shown to lack any detectable antitumor activity. Access to the multitherapy was investigated three years later within the post-bereavement Italian Survey of the Dying of Cancer (ISDOC), whose broader aim was to investigate the end-of-life care experiences of terminal cancer patients. METHODS: ISDOC was carried out in a two-stage probability sample of 2,000 out of 160,000 Italian cancer patients deceased between March 2002 and June 2003. For each cancer patient, a non-professional caregiver, i.e., the closest and the best-informed person about her/his last three months of life, was identified. A specific question concerning the "Di Bella multitherapy" was included in a semi-structured questionnaire that was administered face-to-face to the caregivers by trained interviewers. Weighted estimates of the frequency of patients receiving the multitherapy in the target population and their 95% confidence intervals were computed by taking into account stratification and clustering of observations. RESULTS: During their last three months of life, 0.7% (95% CI, 0.3-1.6) of terminal cancer patients, corresponding to some 1,100 subjects (range, 480-2,560), received the multitherapy. No statistically significant difference was observed for age at death, cancer type, gender, education, marital status, or residence. CONCLUSIONS: The finding indicates that an unconventional cancer treatment proven to lack clinical efficacy remained accessible to Italian cancer patients. Ethical, deontologic, and economic implications call for a routine monitoring of provision of and access to unproven cancer treatments.