Much effort has been made to explore how patients with advanced chronic illness and their families experience care when they attend the Emergency Department, and many studies have investigated how ...healthcare professionals perceive Palliative Care provision in the Emergency Department. Various models exist, but nonetheless incorporating palliative care into the Emergency Department remains challenging. Considering both healthcare professionals' and users' perspective on problems encountered in delivering and receiving appropriate palliative care within this context may provide important insight into meaningful targets for improvements in quality of care. Accordingly, this study aims at exploring issues in delivering palliative care in the Emergency Department from the perspective of both providers and users, as part of a larger project on the development and implementation of a quality improvement program in Italian Emergency Departments.
A qualitative study involving focus group interviews with Emergency Department professionals and semi-structured interviews with patients with palliative care needs in the Emergency Department and their relatives was conducted. Both datasets were analyzed using Thematic Analysis.
Twenty-one healthcare professionals, 6 patients and 5 relatives participated in this study. Five themes were identified: 1) shared priorities in Emergency Department among healthcare professionals and patients, 2) the information provided by healthcare professionals and that desired by relatives, 3) perception of environment and time, 4) limitations and barriers to the continuity of care, and 5) the contrasting interpretations of giving and receiving palliative care.
This study provides insights into targets for changes in Italian Emergency Departments. Room for improvement relates to training for healthcare professionals on palliative care, the development of a shared care pathway for patients with palliative care needs, and the optimization of Emergency Department environment. These targets will be the basis for the development of a quality improvement program in Italian Emergency Departments.
If we focus our attention on seven main features of COVID-19 infection (heterogeneity, fragility, lack of effective treatments and vaccines, "miraculous cures", psychological suffering, deprivation, ...and globalization), we may establish parallelism with the challenges faced in the steep road to the understanding and treatment of neoplastic diseases. How the similarities between these two conditions can help us cope with the emergency effort represented by the management of cancer patients in the COVID-19 era, today and in the future? In a manner similar to the Cancer Moonshot initiative in the United States, we can hypothesize a multinational moonshot project towards the management of cancer patients during COVID-19 pandemic. In particular, we believe that the main road to elaborate meaningful scientific evidence is represented by the collection of all the data on COVID-19 and cancer comorbidity that are and will become available in cancer centers, coupled with the design of large clinical studies. To address this goal, it is essential to identify the entity that can produce this scientific evidences and the potentially most successful research strategy to undertake. The largest Italian organization for cancer research, Alliance Against Cancer (Alleanza Contro il Cancro, ACC), is called to play a scientific leadership in addressing these challenges, which requires the coordination of oncology teams at regional, national, and international levels. To fulfill this commitment, ACC will create a liaison with health government agencies in order to develop "dynamic" indications able to fight such an unpredictable pandemic.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
This article proposes a retrospective analysis of a compassionate use (CU), using a case study of request for Avelumab for a patient suffering from Merkel Cell Carcinoma. The study is the result of a ...discussion within a Provincial Ethics Committee (EC) following the finding of a high number of requests for CU program. The primary objective of the study is to illustrate the specific ethical and clinical profiles that emerge from the compassionate use program (CUP) issue. The secondary goals are: a) to promote a moral reflection among physicians who require approval for the CUP and b) provide the basis for recommendations on how to request CUP.
The instruments for carrying out the analysis of the case study and the discussion are as follows: Analysis of the audio-recording of the EC meeting regarding the selected Case study. In-depth discussion of topics that emerged during the meeting by means of administration of 5 semi-structured interviews with 2 doctors involved in the case (proposing physician and palliative physician) and with 3 components of the EC who played a major role in the EC internal discussion.
In an exploration of emerging clinical and ethical issues, four primary themes arise: 1. efficacy, safety of the treatment and patient's quality of life; 2. clear, realistic, adequate communication; 3. right to hope; 4. simultaneous Palliative Care approach. The results of ethical analysis carried out concern two areas: 1) ethical profiles relating to the use of CUP; 2) the role of the EC concerning the compassionate use of drugs and the need to provide recommendations on how to request CUP. With the aim of implementing these conclusions, the provincial EC of Reggio Emilia chose to steer the request for drugs for compassionate use through recommendations for good clinical and ethical practice based on the following assumptions: 1) the "simultaneous care" approach must be preferred. Secondly, 2) the EC's assessment must be part of the decision-making process that the care team conducts before proposing compassionate use to the patient.
Importance
Despite people with impaired immune competence due to an underlying disease or ongoing therapy, hereinafter frail patients, are (likely to be) the first to be vaccinated, they were usually ...excluded from clinical trials.
Objective
To report adverse reactions of frail patients after receipt of the third dose (booster) administered after completion of a two-dose mRNA vaccination and to compare with those reported after the receipt of the first two doses.
Design
A multicenter, observational, prospective study aimed at evaluating both the safety profile and the immune response of Pfizer-BioNTech or Moderna vaccines in frail patients.
Setting
National Project on Vaccines, COVID-19 and Frail Patients (VAX4FRAIL)
Participants
People consenting and included in the VAX4FRAIL trial.
Exposure
A series of three doses of COVID-19 mRNA vaccination from the same manufacturer.
Main outcome(s) and measure(s)
Evaluation of a self-assessment questionnaire addressing a predefined list of eight symptoms on a five-item Likert scale. Symptoms were classified as severe if the patient rated them as severe or overwhelming.
Results
Among 320 VAX4FRAIL participants diagnosed/treated for hematological malignancies (N=105; 32.8%), solid tumors (N=48; 15.0%), immune-rheumatological diseases (N=60; 18.8%), neurological diseases (N=107; 33.4%), and receiving the booster dose, 70.3% reported at least one loco-regional or systemic reactions. Adverse events were mostly mild or moderate, none being life-threatening. Only six of the 320 (1.9%) patients had their treatment postponed due to the vaccine. The safety profile of the booster compared to previously administered two doses showed a stable prevalence of patients with one or more adverse events (73.5%, 79.7% and 73.9% respectively), and a slightly increment of patients with one or more severe adverse events (13.4%, 13.9% and 19.2% respectively).
Conclusions and relevance
The booster of the mRNA COVID-19 vaccine was safely administered in the largest prospective cohort of frail patients reported so far. VAX4FRAIL will continue to monitor the safety of additional vaccine doses, especially systemic adverse events that can be easily prevented to avoid interruption of continuity of care.
Clinical trial registration
https://clinicaltrials.gov/ct2/show/NCT04848493
, identifier NCT04848493.
The outbreak of the coronavirus 2 disease 2019 (COVID-19) puts an enormous burden on healthcare systems worldwide. This may worsen outcomes in patients with severe chronic diseases such as cancer, ...autoimmune diseases, and immune deficiencies. In this critical situation, only a few available data exist, which do not allow us to provide practical guides for the treatment of oncological or immunocompromised patients. Therefore, a further step forward is needed, addressing the specific needs and demands of frail patients in the pandemic era. Here we aim to present a protocol of a study approved by an ethical committee named “CO.M.E.TA”. CO.M.E.TA protocol is a network project involving six Italian institutions and its goals are: i) to measure and compare the impact of the pandemic on the access of cancer and immunocompromised patients to therapies in three Italian regions; ii) to assess how reorganizational measures put in place in these different institutions have impacted specific metrics of performance; iii) to establish a COVID-19 Biobank of biological samples from SARS-CoV-2 infected patients to be used to study immunological alterations in patients with immune frailty.
Purpose
Cancer-related fatigue (CRF) is one of the most common symptoms experienced by cancer patients (CPs). The Brief Fatigue Inventory (BFI) is a reliable instrument to assess CRF in CPs. The aim ...of this study was to evaluate the psychometric properties of the Italian version of the BFI (BFI-I).
Methods
The BFI-I was developed by using the forward–backward translation approach. The psychometric properties of the BFI-I were assessed in terms of acceptability, internal consistency, and validity. Outpatient CPs filled in BFI-I along with the Medical Outcome Study Quality of Life Short Form 36 (SF36). Demographic and health data were collected.
Results
The BFI-I had an overall Cronbach alpha for the nine items of 0.94. The inter-item mean correlation was 0.64, and coefficients ranged from 0.47 to 0.81 for the nine items. The results of the factor analysis suggested a 1-factor solution explaining 68 % of the variance, supporting the hypothesis of unidimensionality of the BFI-I. The BFI-I score was compared to SF36 subscales score to evaluate concurrent validity. An expected inverse correlation between the BFI-I and the vitality subscale of the SF36 was observed (
r
= −0.67, 95 % confidence interval −0.73 to −0.59). The correlation with the other subscales of the SF36 ranged between −0.56 and −0.13. Discriminant validity analysis showed the BFI-I mean score significantly increased with increasing Eastern Cooperative Oncology Group values (
p
< 0.001).
Conclusions
BFI-I is a clinical instrument with satisfactory psychometric properties to assess CRF in Italian CPs.
Abstract Context General practitioners (GPs) play a key role in the end-of-life care of patients; however, currently in Italy, there are no national population-based studies available of the ...knowledge and activities of GPs in palliative care. Objectives This survey aimed to investigate the knowledge, opinions, and activities of Italian GPs regarding palliative care. Methods A telephone survey of 1690 GPs was performed. Information was gathered through an ad hoc questionnaire. Results Valid interviews were obtained for 88% of the sampled GPs ( n = 1489). Regarding knowledge, 25% of GPs recognized a correct definition of palliative care, 41% the objectives of palliative care, 66% that palliative care should be provided by a multiprofessional team including GPs, and 60% that in-home care for patients at the end of life requires an individual plan care. Furthermore, 92% of them reported that “there is no maximum daily morphine dose for the management of pain.” Regarding opinions, most of the GPs strongly agreed that for patients at the end of life, the GPs' duties included availability during working hours to break bad news to patients and families and to collaborate with the multiprofessional team in establishing an individual care plan. Finally, regarding activities, most GPs reported that, in their daily practice with patients at the end of life, they discontinue the drugs that are not beneficial to symptom management and seek advice from palliative care physicians when symptom management is ineffective. Conclusion This survey reveals the uncertainty of GPs regarding many theoretical issues but a strong willingness to integrate with the multiprofessional palliative care team. To further enhance the skills of GPs and facilitate the collaboration with palliative care services, it might be useful to realize ad hoc training schemes tailored to the different organizational procedures of in-home palliative care services.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background:
Inadequate description of palliative care cancer patients in research studies often leads to results having limited generalizability. To standardize the description of the sample, the ...European Association for Palliative Care basic data set was developed, with 31 core demographic and disease-related variables.
Aim:
To pilot test the data set to check acceptability, comprehensibility and feasibility.
Design:
International, multi-centre pilot study at nine study sites in five European countries, using mixed methods.
Setting/participants:
Adult cancer patients and staff in palliative care units, hospices and home care.
Results:
In all, 191 patients (544 screened) and 190 health care personnel were included. Median time to fill in the patient form was 5 min and the health care personnel form was 7 min. Ethnicity was the most challenging item for patients and requires decisions at a national level about whether or how to include. Health care personnel found weight loss, principal diagnosis, additional diagnoses and stage of non-cancer diseases most difficult to respond to. Registration of diagnoses will be changed from International Statistical Classification of Diseases and Related Health Problems, 10th version code to a predefined list, while weight loss and stage of non-cancer diseases will be removed. The pilot study has led to rewording of items, improvement in response options and shortening of the data set to 29 items.
Conclusion:
Pilot testing of the first version of the European Association for Palliative Care basic data set confirmed that patients and health care personnel understand the questions in a consistent manner and can answer within an acceptable timeframe. The pilot testing has led to improvement, and the new version is now subject to further testing.
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NUK, OILJ, SAZU, UKNU, UL, UM, UPUK
ObjectiveWe aimed at identifying baseline predictive factors for emergency department (ED) readmission, with hospitalisation/death, in patients with COVID-19 previously discharged from the ED. We ...also developed a disease progression velocity index.Design and settingRetrospective cohort study of prospectively collected data. The charts of consecutive patients with COVID-19 discharged from the Reggio Emilia (Italy) ED (2 March 2 to 31 March 2020) were retrospectively examined. Clinical, laboratory and CT findings at first ED admission were tested as predictive factors using multivariable logistic models. We divided CT extension by days from symptom onset to build a synthetic velocity index.Participants450 patients discharged from the ED with diagnosis of COVID-19.Main outcome measureED readmission within 14 days, followed by hospitalisation/death.ResultsOf the discharged patients, 84 (18.7%) were readmitted to the ED, 61 (13.6%) were hospitalised and 10 (2.2%) died. Age (OR=1.05; 95% CI 1.03 to 1.08), Charlson Comorbidity Index 3 versus 0 (OR=11.61; 95% CI 1.76 to 76.58), days from symptom onset (OR for 1-day increase=0.81; 95% CI 0.73 to 0.90) and CT extension (OR for 1% increase=1.03; 95% CI 1.01 to 1.06) were associated in a multivariable model for readmission with hospitalisation/death. A 2-day lag velocity index was a strong predictor (OR for unit increase=1.21, 95% CI 1.08 to 1.36); the model including this index resulted in less information loss.ConclusionsA velocity index combining CT extension and days from symptom onset predicts disease progression in patients with COVID-19. For example, a 20% CT extension 3 days after symptom onset has the same risk as does 50% after 10 days.
Abstract Context A number of studies have highlighted the poor quality of end-of-life (EOL) care provided in hospital settings, leading to a reduction in the quality of EOL care and increase in ...patient and caregiver dissatisfaction levels. Objectives The aims of this study were the evaluation of the prevalence of major symptoms, treatment, outcomes, information, and care provided to dying cancer patients in Italian hospitals; and an analysis of clinical and socio-demographic factors associated with caregiver satisfaction with the health care provided. Methods This is a mortality follow-back survey of 2,000 cancer deaths representative of the country. Caregivers were interviewed about patients' experiences by using a tailored version of the View of Informal Carers—Evaluation of Services questionnaire. Results Valid interviews were obtained for 84% ( n = 364) of the cancer patients who died in hospital. Most Italian cancer patients dying in hospital suffered from a number of untreated or poorly treated symptoms, and only a few reported an acceptable control over physical suffering. Moreover, only two-thirds of patients and one-third of caregivers received basic information on therapies and care. About one-third of the caregivers expressed dissatisfaction with the health care received. The probability of being satisfied was more likely for caregivers of patients living in the north of Italy; caregivers of patients who had not experienced or were only slightly distressed by fatigue; and caregivers who were generally satisfied with hospital facilities and when the health care professionals had provided appropriate information to both patients and caregivers. Conclusion This study revealed poor quality of EOL care in Italian hospitals, with almost one-third of the caregivers expressing their clear dissatisfaction. A national policy is, therefore, urgently called for to improve the quality of EOL care in Italian hospitals.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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