The Hospital Anxiety and Depression Scale (HADS) is a widely used self-report measure to assess emotional distress in clinical populations. As highlighted in recent review studies, the latent ...structure of the HADS is still an issue. The aim of this study was to analyze the factorial structure of the HADS in a large community sample in Italy, and to test the invariance of the best fitting model across age and gender groups.
Data analyses were carried out on a sample of 1.599 participants proportionally stratified according to the Italian census population pyramid. Participants aged 18 to 85 years (females = 51.8%), living in eight different regions of Italy, voluntarily participated in the study. The survey questionnaire contained the HADS, Health Status questions, and sociodemographic variables.
Confirmatory factor analysis indicated that a bifactor model, with a general psychological distress factor and two orthogonal group factors with anxiety and depression, was the best fitting one compared to six alternative factor structures reported in the literature, with overall good fit indices Non-normed Fit Index (NNFI) = .97; Comparative Fit Index (CFI) = .98; Root Mean-Square Error of Approximation (RMSEA) = .04. Multi-group analyses supported total invariance of the HADS measurement model for males and females, and for younger (i.e., 18-44 years old) and older (i.e., 45-85 years old) participants. Our descriptive analyses showed that females reported significant higher anxiety and general distress mean scores than males. Moreover, older participants reported significant higher HADS, anxiety and depression scores than younger participants.
The results of the present study confirmed that the HADS has good psychometric properties in an Italian community sample, and that the HADS scores, especially the general psychological distress one, can be reliably used for assessing age and gender differences. In keeping with the most recent factorial studies, our analysis supported the superior fit of a bifactor model. However, the high factor loadings on the general factor also recommend caution in the use of the two subscales as independent measures.
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Background: COVID-19 has been causing a high burden of suffering for patients and families. There is limited evidence on the preparedness of Indian palliative care services for the pandemic. Aim: ...This study aimed to assess the preparedness and capacity of Indian palliative care services in response to the COVID-19 pandemic. Methods: A cross-sectional online survey was developed based on prior evidence and international health regulations. It was emailed to the Indian Palliative Care Association members and investigators' professional networks in India. One participant per palliative care service was requested. Descriptive analysis was used. Results: Representatives of 78 palliative care services completed the survey. Three in four services had COVID-19 case definition and adapted their protocols for infection control (75%). About half of the services (55%) reported concerns about achieving appropriate hand hygiene in the community. More than half of the services (59%) had capacity to train nonspecialists for symptom control and psychological support. About half of the services reported that they had plans to redeploy staff (56%) and resources (53%) in the case of outbreaks. Two-fifths of the services used paper records to store an updated contact list of staff (40%) and did not have designated focal contacts for information update (40%). Staff anxiety related to personal infection risk and family care was relatively high (median score = 7 on a 1-10 scale). Conclusion: We recommend the following resource allocation to enable palliative care services to support the Indian health system in delivering essential care in this and future pandemics: (1) infection control, especially in the community; (2) training using existing clinical protocols to strengthen palliative care across the health system; and (3) redeployment plans.
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Most cancer patients still die in hospital, mainly in medical wards. Many studies in different countries have shown the poor quality of end-of-life care delivery in hospitals. The Program "Liverpool ...Care Pathway for the dying patient" (LCP), developed in the UK to transfer the hospice model of care into hospitals and other care settings, is a complex intervention to improve the quality of end-of-life care. The results from qualitative and quantitative studies suggest that the LCP Program can improve significantly the quality of end-of-life care delivery in hospitals, but no randomised trial has been conducted till now.
This is a randomized cluster trial, stratified by regions and matched for assessment period. Pairs of eligible medical wards from different hospitals will be randomized to receive the LCP-I Program or no intervention until the end of the trial. The LCP-I Program will be implemented by a Palliative Care Unit.The assessment of the end-points will be performed for all cancer deaths occurred in the six months after the end of the LCP-I implementation in the experimental wards and, in the same period of time, in the matched control wards. The primary end-point is the overall quality of end-of-life care provided on the ward to dying cancer patients and their families, assessed using the Global Scale of the Italian version of the Toolkit "After-death Bereaved Family Member Interview".
This study can be interpreted as a Phase III trial according to the Medical Research Council Framework. In this study, the effectiveness of a fully defined intervention is assessed by comparing the distribution of the endpoints in the experimental and in the control arm. RESEARCH ID: RFPS-2006-6-341619
ClinicalTrials.gov Identifier: NCT01081899.
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Few empirical data show the pattern of functional decline at the end of life for cancer patients, especially among older patients.
In a mortality follow-back survey (the Italian Survey of the Dying ...of Cancer - ISDOC) a random sample of 1,271 lay caregivers were interviewed, at a mean of 234 days after bereavement. The main outcome was number of days before death when the patient experienced a permanent functional decline.
1,249 (98%) caregivers answered the question about patient's function. The probability to be free from a functional disability was high (94%) 52 weeks before death, but was lower for older age groups (15% for those aged 85 or more) and women (8%). It remained stable until 18 weeks before death, then fell to 63% at 12 weeks and 49% at 6 weeks before death (among those aged 85 or more the figures were 50% and 41%). The pattern was consistent across sub-groups, except for patients affected by Central Nervous System tumors who experienced a longer, slower functional decline.
This study provides empirical support for the declining trajectory in cancer, and suggests that the decline commences at around 12 weeks in all age groups, even among patients over 85 years.
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An increasing number of cancer patients live longer, and palliative care has become an important part of their treatment. Symptoms are often inadequately assessed and managed. A significant challenge ...in clinical trials is to control for the variability of the samples being studied. To overcome this problem, classification systems have been developed in order to characterise and stratify patients by grouping them according to major common characteristics. The lack of agreed methods for the assessment and classification of cancer pain has been clearly indicated in clinical trials and in clinical practice and may be one possible explanation for the inadequate treatment of cancer pain. This was the background to an international expert meeting arranged in September 2009 in Milan, Italy. The primary aims were to produce recommendations on how to assess and classify cancer pain and to recommend a strategy for the further development, validation and implementation of an international cancer pain classification and assessment system. The recommendations consisted of two basic working proposals, nine specific working proposals and seven recommendations for the further development of a cancer pain classification system. Examples of specific working proposals were to include pain intensity, pain mechanism, breakthrough pain and psychological distress as the core domains in this classification of cancer pain and to measure pain intensity with a 0-10 numerical rating scale with 'no pain' and 'pain as bad as you can imagine' as anchors. The proposed name for this international standard is Cancer Pain Assessment and Classification System (CPACS).
To compare team assessments of end-of-life communication in three European countries, and to identify factors associated with problematic communication.
Three prospective cohort studies used similar ...standardized procedures, and included patients referred to palliative care services in the United Kingdom, Ireland, and Italy. Palliative team care staff assessed three components of communication in the last week of the patient's life-between the patient and family (or those close to them), between professionals and patient and family, and between professionals-using a validated measure. Univariate and multivariate analyses explored the data and tested for relationships between possible explanatory variables and communication.
Data were collected on 1,326 patients, 416 in the United Kingdom, 411 in Ireland, and 499 in Italy. Mean age was 68 years (range, 19 to 95 years), 55% were male, and almost two thirds were married. Team members assessed that communication between patient and family was a moderate or severe problem in the last week of life for 30% to 40% of patients; 10% to 20% had moderate or severe problems recorded for the other two communication items. Problematic communication was associated with respiratory and breast cancers, a shorter time in care, and hospice death. It was also associated with greater spiritual need, need for care planning, and poorer patient and family insight (Spearman's rho > 0.4), but not especially with pain and symptom control, in both univariate and multivariate analyses, both within countries and for all data combined.
Severe communication problems were reported by team assessments in up to 40% of patients at the end of life. A multiprofessional approach is needed to recognize and improve this.
IMPORTANCE: The coronavirus disease 2019 (COVID-19) pandemic is threatening billions of people worldwide. Tocilizumab has shown promising results in retrospective studies in patients with COVID-19 ...pneumonia with a good safety profile. OBJECTIVE: To evaluate the effect of early tocilizumab administration vs standard therapy in preventing clinical worsening in patients hospitalized with COVID-19 pneumonia. DESIGN, SETTING, AND PARTICIPANTS: Prospective, open-label, randomized clinical trial that randomized patients hospitalized between March 31 and June 11, 2020, with COVID-19 pneumonia to receive tocilizumab or standard of care in 24 hospitals in Italy. Cases of COVID-19 were confirmed by polymerase chain reaction method with nasopharyngeal swab. Eligibility criteria included COVID-19 pneumonia documented by radiologic imaging, partial pressure of arterial oxygen to fraction of inspired oxygen (Pao2/Fio2) ratio between 200 and 300 mm Hg, and an inflammatory phenotype defined by fever and elevated C-reactive protein. INTERVENTIONS: Patients in the experimental arm received intravenous tocilizumab within 8 hours from randomization (8 mg/kg up to a maximum of 800 mg), followed by a second dose after 12 hours. Patients in the control arm received supportive care following the protocols of each clinical center until clinical worsening and then could receive tocilizumab as a rescue therapy. MAIN OUTCOME AND MEASURES: The primary composite outcome was defined as entry into the intensive care unit with invasive mechanical ventilation, death from all causes, or clinical aggravation documented by the finding of a Pao2/Fio2 ratio less than 150 mm Hg, whichever came first. RESULTS: A total of 126 patients were randomized (60 to the tocilizumab group; 66 to the control group). The median (interquartile range) age was 60.0 (53.0-72.0) years, and the majority of patients were male (77 of 126, 61.1%). Three patients withdrew from the study, leaving 123 patients available for the intention-to-treat analyses. Seventeen patients of 60 (28.3%) in the tocilizumab arm and 17 of 63 (27.0%) in the standard care group showed clinical worsening within 14 days since randomization (rate ratio, 1.05; 95% CI, 0.59-1.86). Two patients in the experimental group and 1 in the control group died before 30 days from randomization, and 6 and 5 patients were intubated in the 2 groups, respectively. The trial was prematurely interrupted after an interim analysis for futility. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of hospitalized adult patients with COVID-19 pneumonia and Pao2/Fio2 ratio between 200 and 300 mm Hg who received tocilizumab, no benefit on disease progression was observed compared with standard care. Further blinded, placebo-controlled randomized clinical trials are needed to confirm the results and to evaluate possible applications of tocilizumab in different stages of the disease. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04346355; EudraCT Identifier: 2020-001386-37
Study objective: The Italian Survey of the Dying of Cancer (ISDOC) was undertaken to evaluate the experiences of Italian people dying from cancer during their last three months of life in all ...settings of care. Study design: A two-stage probability sample was used to estimate end-of-life outcomes of about 160 000 Italian cancer deaths. In the first stage, 30 of the 197 Italian Local Health Districts (LHD) were randomly selected after stratification. In the second stage, a fixed proportion of cancer deaths was randomly drawn from each LHD, and 2000 death certificates of patients who died of cancer were identified. The non-professional caregivers were identified and interviewed using a semi-structured questionnaire derived from the Views of Informal Carers - Evaluation of Services (VOICES). Results: Caregivers were successfully identified for 95% of the sample (n = 1900). The caregiver was the child (42.7%), the spouse (36.5%), another family member (17.3%), or a friend (1.5%). Only 3% of the sample had no non-professional support. An interview was obtained for 1289 (64.5%) of the sample, at a median time of 234 days after death (range: 103-374). Higher response rates were associated with home death (67.7%) and with a higher education (>70%). Conversely, a lower response rate was observed when the caregiver was the spouse (56.2%). Response rates ranged from about 80% for letters sent four to six months after the patients’ death to about 60% for letters sent after eight months or more. A descriptive analysis of refusals, based on the transcripts of the telephone calls, allowed classification of 61% of refusals for at least one of the two dimensions examined: caregiver psychological suffering and quality of care received by the patient. Psychological suffering was present in 99% of refusals examined for this dimension (48%). Conversely, a poor quality of care was reported by 63% of the refusals examined for this dimension (23%). Conclusion: The ISDOC survey provides a representative picture of the needs and problems associated with the last three months of life of Italian cancer patients.
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50.
Safe tracheotomy for patients with COVID-19 Botti, Cecilia; Lusetti, Francesca; Castellucci, Andrea ...
American journal of otolaryngology,
07/2020, Volume:
41, Issue:
4
Journal Article
Peer reviewed
Open access
Patients affected by severe acute respiratory syndrome coronavirus 2 disease (COVID-19) with respiratory distress may need invasive mechanical ventilation for a long period of time. Head and neck ...surgeons are becoming increasingly involved in the care of COVID-19 patients because of the rapidly increasing number of tracheotomies required. This procedure, when performed without protection, may lead to the infection of the medical and nursing staff caring for the patient.
The aim of this report is to share our protocol for performing a safe surgical tracheotomy in COVID-19 patients. Infection of the nursing/medical staff involved in the first 30 tracheotomies performed in patients affected by COVID-19 in the Intensive Care Unit of a tertiary referral center were evaluated. Mistakes that occurred during surgery were analyzed and discussed. None of the nursing/medical staff presented signs or symptoms of COVID-19 within 15 days after the procedure.
Conclusion: The authors have prepared a protocol for performing a safe surgical tracheotomy in patients affected by COVID-19. Surgeons who might be involved in performing the tracheotomies should become familiar with these guidelines.
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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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