Paola Di Giulio

Predicting survival in terminal cancer patients: clinical observation or quality-of-life evaluation?

Introduction: This study compares the relative prognostic power of clinical variables and quality-of-life (QoL) measures in a population of terminal cancer patients. Methods: A prospective cohort study in 58 Italian Palliative Care Units. Of the 601 randomly selected terminal cancer patients, 574 were followed until death in order to compare clinical and QoL variables (using the Therapy Impact Questionnaire (TIQ) as predictors of survival, and assess whether their combined implementation makes prediction more accurate. Results: The clinical variables most strongly associated with survival were dyspnoea, cachexia, Katzs ADL, oliguria, dysphagia, dehydration, liver and acute kidney failure and delirium (hazard ratios (HR) ranging from 2.10 to 3.01). Only the first four kept their strength once introduced in the Cox model (HRs ranging from 1.95 to 2.22). In the TIQ primary scale the strongest predictors were physical wellbeing, fatigue, functional status and cognitive status (HRs ranging from 1.42 to 1.71), but only fatigue showed an independent prognostic relevance (90% of selection). In the TIQ global scales, the Physical Symptom Index showed a stronger association with survival (HR 1.71) than the Therapy Impact Index (HR 1.47). The former marginally improved the prognostic power of the model when added to clinical variables. Internal validation confirmed that the results were not spurious. Conclusions: In terminal cancer patients, clinical variables are better predictors of survival than QoL. The large residual variability not accounted for by the model (: ≈ 70%) suggests that survival is also influenced by factors unlikely to be identified in a survey.

Treatments and Prescriptions in Advanced Dementia Patients Residing in Long-Term Care Institutions and at Home

Dementia is an incurable condition resulting in a progressive but patchy decay characterized by dementia related events such as recurrence of infections and eating problems, as well as by acute conditions typical of frailty and/ or the worsening of chronic comorbidities. Its duration is reported to range from three to over nine years. Although not everyone will reach the advanced stage, many patients experience a highly severe and persistent disability. Health professionals may not always acknowledge advanced dementia as a terminal disease, and this may result in patients being exposed to aggressive treatments. The prescription regimen should be reconsidered not only to avoid overtreatment and side effects of drugs, but also to improve comfort and symptom control. In far advanced stages, some medications previously prescribed for comorbidities could likely be discontinued to reduce burden, adverse effects, and costs. A model for defining the concept of prescriptions’ appropriateness in advanced dementia was proposed by Holmes and colleagues taking into account factors such as patients’ life expectancy and goals of care. Many patients with advanced dementia are cared for until death in nursing homes (NHs), and studies have shown that drug regimens may be far from optimal. However, others die at home, cared for by home care service (HC). Information on the treatments and prescriptions for patients with advanced-stage dementia cared for at home are scarce. We expected differences, because drug regimes may be critically reconsidered and revised upon admission to institutional long-term care by physicians on staff of NHs. The aim of this paper is to assess and compare treatments and prescriptions of patients with advanced dementia cared for in NHs and in HC and assess their appropriateness from a palliative care perspective.

Off-Label Prescriptions in Italian Hospices: A National Survey

Off-label prescription is part of routine care in palliative medicine, but no information is available about the situation in Italy. A cross-sectional observational survey was undertaken on all 66 Italian palliative care freestanding inpatient units to describe off-label prescriptions. Data were collected on 507 patients. Each prescribed drug was matched with Italian Marketing Authorization indications: 159 drugs off-label (4.5% of all prescribed drugs) for the stated indication were given to 128 patients (25.2%), and drugs unlicensed for subcutaneous injection were given to 147 patients (85.4% of all subcutaneous prescriptions, excluding insulin and heparin). The off-label prescriptions were subsequently evaluated by referring to the Italian National Pharmaceutical Formulary (INPF) and the British Palliative Care Formulary (PCF2). Although drugs are frequently prescribed off-label in inpatient palliative care units in Italy, this strategy was not always backed by clinical evidence, and in some cases, official/authoritative sources, such as INPF and PCF2 did not support it. Clinical trials and/or agreed international guidelines are needed to support the off-label use of the most widely prescribed drugs in palliation.

Validation of the Italian version of the Discomfort Scale - Dementia of Alzheimer Type

AIM This paper is a report of a study to validate the Discomfort Scale - Dementia of Alzheimer Type in Italian. BACKGROUND Dementia is a long and highly debilitating illness with a slow course and a steadily rising prevalence. Improving the quality of life of patients with dementia requires instruments to measure their problems and symptoms, because they are unable to communicate and interact with others. In Italy, there are no validated scales to assess discomfort for this population. The Discomfort Scale - Dementia of Alzheimer Type was developed in the USA and has been further tested there as well as in Germany. METHODS The data were collected by 21 nurses during 2006 in five nursing homes with 71 patients with severe dementia. Face and content validity were evaluated in a focus group. Discriminant validity was assessed with the opposite-group approach and internal consistency and inter-rater reliability were measured. RESULTS The discriminant validity of the Italian Discomfort Scale - Dementia of Alzheimer Type showed its ability to detect patients with high and low levels of discomfort. Reliability testing gave positive results: the internal consistency level was satisfactory (0.814) and comparisons of overall discomfort scores across nurses show good reliability. CONCLUSION These findings support the use of Discomfort Scale - Dementia of Alzheimer Type in a clinical setting for people with severe dementia for both research and practice. Its ease of use and comprehensibility, and the limited time required to observe patients renders the Discomfort Scale - Dementia of Alzheimer Type a practical instrument for assessment and choosing care interventions.

Regular Wine Consumption in Chronic Heart Failure: Impact on Outcomes, Quality of Life, and Circulating Biomarkers

Background— Moderate, regular alcohol consumption is generally associated with a lower risk of cardiovascular events but data in patients with chronic heart failure are scarce. We evaluated the relations between wine consumption, health status, circulating biomarkers, and clinical outcomes in a large Italian population of patients with chronic heart failure enrolled in a multicenter clinical trial. Methods and Results— A brief questionnaire on dietary habits was administered at baseline to 6973 patients enrolled in the Gruppo Italiano per lo Studio della Sopravvivenza nell’Insufficienza Cardiaca-Heart Failure (GISSI-HF) trial. The relations between wine consumption, fatal and nonfatal clinical end points, quality of life, symptoms of depression, and circulating biomarkers of cardiac function and inflammation (in subsets of patients) were evaluated with simple and multivariable-adjusted statistical models. Almost 56% of the patients reported drinking at least 1 glass of wine per day. After adjustment, clinical outcomes were not significantly different in the predefined 4 groups of wine consumption. However, patients with more frequent wine consumption had a significantly better perception of health status (Kansas City Cardiomyopathy Questionnaire score, adjusted P <0.0001), less frequent symptoms of depression (Geriatric Depression Scale, adjusted P =0.01), and lower plasma levels of biomarkers of vascular inflammation (osteoprotegerin and C-terminal proendothelin-1, adjusted P <0.0001, and pentraxin-3, P =0.01) after adjusting for possible confounders. Conclusions— We show for the first time in a large cohort of patients with chronic heart failure that moderate wine consumption is associated with a better perceived and objective health status, lower prevalence of depression, and less vascular inflammation, but does not translate into more favorable clinical 4-year outcomes. Clinical Trial Registration— URL: . Unique identifier: NCT0033633.Background—Moderate, regular alcohol consumption is generally associated with a lower risk of cardiovascular events but data in patients with chronic heart failure are scarce. We evaluated the relations between wine consumption, health status, circulating biomarkers, and clinical outcomes in a large Italian population of patients with chronic heart failure enrolled in a multicenter clinical trial. Methods and Results—A brief questionnaire on dietary habits was administered at baseline to 6973 patients enrolled in the Gruppo Italiano per lo Studio della Sopravvivenza nell’Insufficienza Cardiaca-Heart Failure (GISSI-HF) trial. The relations between wine consumption, fatal and nonfatal clinical end points, quality of life, symptoms of depression, and circulating biomarkers of cardiac function and inflammation (in subsets of patients) were evaluated with simple and multivariable-adjusted statistical models. Almost 56% of the patients reported drinking at least 1 glass of wine per day. After adjustment, clinical outcomes were not significantly different in the predefined 4 groups of wine consumption. However, patients with more frequent wine consumption had a significantly better perception of health status (Kansas City Cardiomyopathy Questionnaire score, adjusted P<0.0001), less frequent symptoms of depression (Geriatric Depression Scale, adjusted P=0.01), and lower plasma levels of biomarkers of vascular inflammation (osteoprotegerin and C-terminal proendothelin-1, adjusted P<0.0001, and pentraxin-3, P=0.01) after adjusting for possible confounders. Conclusions—We show for the first time in a large cohort of patients with chronic heart failure that moderate wine consumption is associated with a better perceived and objective health status, lower prevalence of depression, and less vascular inflammation, but does not translate into more favorable clinical 4-year outcomes. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT0033633.

What is the healing time of stage II pressure ulcers? Findings from a secondary analysis

Pressure ulcers (PrUs) remain a concern for clinicians, patients, caregivers, and researchers. Although data on prevalence and incidence are available, as well as evidence-based prevention and management intervention, PrU healing time is underreported. OBJECTIVE: The objective of this study was to evaluate the healing time of Stage II PrUs. METHODS: Secondary analysis of data collected from a multicenter randomized clinical trial was undertaken. Patients (a) with a Stage II PrU, (b) older than 18 years, and (c) who had given informed consent were included. The endpoints of the study were complete re-epithelialization of the PrU measured with the Pressure Ulcer Scale for Healing Tool 3.0 and the healing time. A network of 46 healthcare centers located in northern Italy participated in the study. RESULTS: Two hundred seventy patients with an average age of 83.9 years (95% confidence interval [CI], 82.71–85.10) were recruited. Among 270 Stage II PrUs included, 153 lesions healed (56.7%), whereas 74 (27.4%) were still present after 10 weeks of follow-up. For 43 lesions (15.9%), the follow-up evaluation was interrupted because of patient death or transfer to units not included in the study. The PrUs healed on an average of 22.9 days (95% CI, 20.47–25.37 days), with a median of 18 days. The average healing time for PrUs of less than 3.1 cm2 was significantly shorter (19.2 days; 95% CI, 16.6–21.8) compared with those 3.1 cm2 or greater (31.0 days; 95% CI, 26.4–35.6 days) (P = .000). CONCLUSIONS: To achieve complete re-epithelialization in Stage II PrUs, it takes approximately 23 days. This is quite a long time if we consider that pressures of only 60 to 70 mm Hg for between 30 and 240 minutes are needed to cause tissue damage. On average, a small ulcer heals 12 days faster compared with those with a surface of 3.1 cm2 or greater.

Pneumonia in Nursing Home Patients With Advanced Dementia: Decisions, Intravenous Rehydration Therapy, and Discomfort

Background: Comfort may be an appropriate goal in advanced dementia. Longitudinal studies on physician decision-making and discomfort assessed by direct observation are rare, and intravenous rehydration therapy is controversial. Methods: To assess treatment decisions and discomfort in patients with advanced dementia and pneumonia and to compare by intravenous rehydration therapy, we used data from the observational multicenter Italian End of Life Observatory–Prospective Study On DEmentia patients Care. We analyzed 109 episodes of pneumonia, which involved decisions in 77 nursing home patients with Functional Assessment Staging Tool stage 7. We assessed decisions, decision-making, and treatments every fortnight. Trained observers assessed discomfort with the Discomfort Scale–Dementia Alzheimer Type (DS-DAT). Results: Most decisions referred to treatment with antibiotics (90%; 98 of 109) and intravenous rehydration therapy (53%; 58 of 109), but hospitalization was rare (1%). Selecting decisions with antibiotics, with rehydration therapy, the prognosis was more frequently <15 days (34% vs 5% without rehydration therapy; P = .001), and a goal to reduce symptoms/suffering was more common (96% vs 74%; P = .005) while there was no difference in striving for life prolongation (a minority). With rehydration therapy, the decision was more often discussed with family rather than communicated only. Mean DS-DAT scores over time proximate to the first decision ranged between 9.2 and 10.5. Conclusions: Italian nursing home patients with advanced dementia and pneumonia frequently received invasive rehydration therapy in addition to antibiotics, however, mostly with a palliative intent. Discomfort was high overall and symptom relief may be improved. Relations between invasive rehydration therapy and discomfort need further study.

Delayed chemotherapy-induced nausea and vomiting in autologous hematopoietic cell transplant patients: an exploratory analysis.

Purpose Delayed chemotherapy-induced nausea and vomiting (CINV) continues to be a problem in patients undergoing a hematopoietic cell transplant (HCT) despite progress in antiemetic prophylaxis. This study investigated the clinical course of nausea and vomiting (NV) and retching over the 5 days following an autologous HCT in a transplant setting. Methods This longitudinal observational study was an exploratory analysis of data from a trial that assessed the efficacy of aroma in preventing NV related to dimethyl sulfoxide in 69 autologous HCT patients undergoing highly emetogenic chemotherapy (HEC; n = 56) or moderately emetogenic chemotherapy (MEC; n = 13). Results Nausea started to increase on the second day after reinfusion, with a peak between 72 and 96 hours, and decreased on the fifth day. The pattern for vomiting was similar, while retching episodes remained unchanged after the third day following transplant. Nausea and emesis were observed in 73% (n = 41) and 64% (n = 36) of HEC patients, respectively, and in 85% (n = 11) and 62% (n = 8) of MEC patients, respectively. Conclusions Uncontrolled delayed CINV is still a challenge for autologous HCT patients. Nausea, vomiting and retching are 3 different symptoms that should be assessed and managed separately in routine clinical practice.

Contatto con morte, malattia e scelta della carriera nelle professioni sanitarie non mediche e negli studenti di economia: un’analisi trasversale

Abstract . Contact with death or illness and career choice in non-medical health professions and business students: a cross-sectional analysis. PURPOSE: It is anecdotally reported that a personal severe illness or the death of a significant person might be key reasons for the choice of a career in the non-medical health professions. AIM: The aim of the questionnaire was to explore past relevant life events before starting professional studies (severe personal illness; severe illness or death of a significant person; drug addiction of a relative or friend) by comparing students of nursing or other non medical health professions with business students. METHODS: An anonymous questionnaire with standardized closed questions was distributed in 2010 to a group of bachelor students of non-medical health professions (nursing, physiotherapy, occupational therapy and rescue care) and to a control group of business students at the University of Applied Sciences and Arts of Southern Switzerland. RESULTS: Students of non-medical health professions had been, compared to business students, significantly more exposed to severe illnesses or the death of a relative (OR 3.070, CI95% 1.716-5.494), to personal severe illness (OR 3.950, CI95% 1.384-11.279) and to addiction of a relative or friend (OR 2.672, CI95% 1.316-5.422) before starting their professional studies. CONCLUSIONS: This cross-sectional analysis suggests that exposure to a severe illness or death may play an important role in the choice of career, probably by supporting intrinsic motivations. Further research should explore the role of those past life experience in professional behavior.

Regular Wine Consumption in Chronic Heart FailureCLINICAL PERSPECTIVE

Background— Moderate, regular alcohol consumption is generally associated with a lower risk of cardiovascular events but data in patients with chronic heart failure are scarce. We evaluated the relations between wine consumption, health status, circulating biomarkers, and clinical outcomes in a large Italian population of patients with chronic heart failure enrolled in a multicenter clinical trial. Methods and Results— A brief questionnaire on dietary habits was administered at baseline to 6973 patients enrolled in the Gruppo Italiano per lo Studio della Sopravvivenza nell’Insufficienza Cardiaca-Heart Failure (GISSI-HF) trial. The relations between wine consumption, fatal and nonfatal clinical end points, quality of life, symptoms of depression, and circulating biomarkers of cardiac function and inflammation (in subsets of patients) were evaluated with simple and multivariable-adjusted statistical models. Almost 56% of the patients reported drinking at least 1 glass of wine per day. After adjustment, clinical outcomes were not significantly different in the predefined 4 groups of wine consumption. However, patients with more frequent wine consumption had a significantly better perception of health status (Kansas City Cardiomyopathy Questionnaire score, adjusted P <0.0001), less frequent symptoms of depression (Geriatric Depression Scale, adjusted P =0.01), and lower plasma levels of biomarkers of vascular inflammation (osteoprotegerin and C-terminal proendothelin-1, adjusted P <0.0001, and pentraxin-3, P =0.01) after adjusting for possible confounders. Conclusions— We show for the first time in a large cohort of patients with chronic heart failure that moderate wine consumption is associated with a better perceived and objective health status, lower prevalence of depression, and less vascular inflammation, but does not translate into more favorable clinical 4-year outcomes. Clinical Trial Registration— URL: . Unique identifier: NCT0033633.Background—Moderate, regular alcohol consumption is generally associated with a lower risk of cardiovascular events but data in patients with chronic heart failure are scarce. We evaluated the relations between wine consumption, health status, circulating biomarkers, and clinical outcomes in a large Italian population of patients with chronic heart failure enrolled in a multicenter clinical trial. Methods and Results—A brief questionnaire on dietary habits was administered at baseline to 6973 patients enrolled in the Gruppo Italiano per lo Studio della Sopravvivenza nell’Insufficienza Cardiaca-Heart Failure (GISSI-HF) trial. The relations between wine consumption, fatal and nonfatal clinical end points, quality of life, symptoms of depression, and circulating biomarkers of cardiac function and inflammation (in subsets of patients) were evaluated with simple and multivariable-adjusted statistical models. Almost 56% of the patients reported drinking at least 1 glass of wine per day. After adjustment, clinical outcomes were not significantly different in the predefined 4 groups of wine consumption. However, patients with more frequent wine consumption had a significantly better perception of health status (Kansas City Cardiomyopathy Questionnaire score, adjusted P<0.0001), less frequent symptoms of depression (Geriatric Depression Scale, adjusted P=0.01), and lower plasma levels of biomarkers of vascular inflammation (osteoprotegerin and C-terminal proendothelin-1, adjusted P<0.0001, and pentraxin-3, P=0.01) after adjusting for possible confounders. Conclusions—We show for the first time in a large cohort of patients with chronic heart failure that moderate wine consumption is associated with a better perceived and objective health status, lower prevalence of depression, and less vascular inflammation, but does not translate into more favorable clinical 4-year outcomes. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT0033633.