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Objective: The first instruments developed to evaluate specific logotherapeutic dimensions were the Purpose In Life (PIL) and the Seeking Of Noetic Goals (SONG) tests, designed to reflect Frankl's concepts of, respectively, meaning in life attainment and will to meaning. This study aims to perform the Italian cultural adaptation and the psychometric validation of the PIL and SONG questionnaires. Methods: We administered the PIL and SONG, culturally adapted into the Italian language, to 266 cancer patients. The psychometric validation appraised construct validity, internal consistency, test-retest reliability, known-group validity, and convergent validity of the two questionnaires with respect to one another. Results: The factorial analysis indicates that the original single-factor solution can be maintained for both instruments (proportion of variance explained by the first factor 77% and 71% for the PIL and SONG, respectively). The results show excellent internal consistency (Cronbach's alpha of 0.91 for the PIL and 0.90 for the SONG) and test-retest reliability (intraclass correlation coefficient of 0.92 for the PIL and 0.81 for the SONG). As expected, males, believers, patients nearer to the diagnosis, and patients not undergoing psychological therapy have higher PIL and lower SONG scores, while expectations for age were not confirmed. The average level for the PIL was 107.3, while for the SONG, it was 66.1, and a negative correlation (−0.47) between PIL and SONG scores indicates good convergent validity of the two instruments. Conclusion: Italian versions of the PIL and SONG are adequate and reliable self-report instruments for evaluating purpose in life and the motivation to find purpose for cancer patient populations. [ABSTRACT FROM AUTHOR]

MICCINESI G., BIANCHI E., BRUNELLI C. & BORREANI C. (2012) European Journal of Cancer Care 21, 623-633 End-of-life preferences in advanced cancer patients willing to discuss issues surrounding their terminal condition The aim of the present study is to describe end-of-life preferences of advanced cancer patients willing to talk about death issues. Eighty-eight advanced cancer patients were interviewed through End of Life Preferences Interview (ELPI), a 23-item interview covering a wide range of end-of-life care issues. Most interviewed subjects were home care patients and their median survival after ELPI administration was 69 days. In total, 100% of responders expressed the will to receive some kind of information on the disease process and/or the treatments proposed. Approximately 77% declared to be willing to talk about what it is important at the end of life in case of worsening of their conditions and 31% prefer to be left alone in difficult moments. Approximately 67% choose home as the preferred place of death and 63% think it is preferable to die in a state of unconsciousness induced by drugs. About half of responders declare to believe in any kind of life after death and 40% consider very important to find any meaning at the end of life. ELPI can be a useful instrument to adapt the model of care to the specific needs and values of each patient. [ABSTRACT FROM AUTHOR]

Purpose: There is increasing interest in integrating electronic patient-reported outcomes (e-PROs) into clinical routines in cancer settings. However, little is known about patients' experiences with and perceptions of e-PRO measures (e-PROMs). This study examines patients' experiences with e-PROMS, particularly their perspectives about its usefulness and its implications for the clinical encounter with their doctors., Method: A total of 19 individual in-person interviews with cancer patients at a Comprehensive Cancer Center in northern Italy conducted in 2021 inform this study., Results: The findings suggested that, overall, patients had positive attitudes towards data collection using e-PROMs. On the one hand, most patients found the integration of e-PROMs into routine clinical practice as beneficial in treating patients with cancer. The main benefits of e-PROMs according to this group of patients were that: they promoted patient-centred care; could be used to tailor and improve the quality of care through a holistic approach; supported early detection of problematic symptoms; increased patient self-awareness; and contributed to clinical research. On the other hand, many patients did not fully understand the purpose of e-PROMs and some patients were also sceptical about their usefulness in routine clinical practice., Conclusions: These findings have several practical implications for ensuring the successful implementation of e-PROMs in routine clinical practice. These include the following preconditions: patients are informed about the purposes of data collection; physicians provide feedback to patients about the e-PROMs' results; and that hospital administrators allocate sufficient time for clinical interactions to integrate e-PROMs into routine clinical practice., Competing Interests: Declaration of competing interest The authors declare that they have no conflicts of interest., (Copyright © 2023. Published by Elsevier Ltd.)

Few studies have investigated the needs of patients with metastatic breast cancer (MBC), and none have been conducted in Italy. Three categories of needs have been identified from the literature: information, support, and practical resources. The present study aims to achieve an in-depth understanding of the patients' needs related to the MBC care pathway. In-depth interviews were conducted and analyzed by thematic analysis. The participants were 9 women with MBC (age range 36-74) who were enrolled at the Fondazione IRCCS Istituto Nazionalde dei tumori, in Milan. The analysis enabled us to identify four themes (which reflect the needs of the participants), each divided into numerous sub-themes: (1) the need for clinical recognition, (2) the need for more attention from healthcare professionals, (3) the need for more and better services to be available at the hospital, (4) the need for specific public health policies. Since the metastatic phase of breast cancer seems to elicit additional, specific needs and multi-level management, changes in attitudes and multidisciplinary practices should be tested in order to ascertain how these needs can be met., (© 2021. American Association for Cancer Education.)

Background: Despite evidence of the positive impact of routine assessment of patient-reported outcome measures (PROMs), their systematic collection is not widely implemented in cancer care., Aim: To assess the knowledge, use and attitudes of healthcare professionals (HCPs) towards PROMs and electronically collected PROMs (ePROMs) in clinical practice and research and to explore respondent-related factors associated with the above dimensions., Method: An ad hoc developed online survey was administered to all HCPs employed in clinical activity in an Italian comprehensive cancer center. The survey investigated which PROMs were known and used, as well as HCPs' opinions on the advantages and drawbacks of routine PROM assessment, including electronic assessment (ePROM). Linear and logistic regression models were used for association analyses., Results: Five Hundred Eleven of nine hundred ninety-two invited HCPs (52%) provided analyzable responses. 68% were women, 46% were nurses and 42% physicians, and 52.5% had > 20 years seniority. The average number of PROMs known was six among 17 proposed. All proved to be under-used (< 28%) except unidimensional and multidimensional pain scales (77 and 36%). Respondents expressed an overall positive attitude towards PROMs, with strengths outweighing weaknesses (mean overall scores 3.6 and 2.9, respectively, on a 1-5 scale). 67% of respondents preferred electronic collection over paper and pencil. Profession was associated with knowledge and use (physicians reported knowing more PROMs than other professionals) and with a preference for electronic collection (nurses were less likely to prefer the electronic format than physicians). Senior HCPs were slightly more critical about both PROMs and electronic administration., Conclusions: This survey indicates an acceptable level of knowledge of common PROM tools but low usage in practice. Based on the generally positive attitude of HCPs, routine implementation of ePROMs can be promoted as long as adequate resources and training are provided., Trial Registration: Not registered., (© 2022. The Author(s).)

Aims: The role of the implantable cardioverter defibrillator (ICD) in primary prevention real-world population is debated. We sought to evaluate the incidence, predictors and prognostic impact of ICD shocks in consecutive heart failure patients implanted for primary prevention at our tertiary institution., Methods and Results: We retrospectively selected a sample of 497 patients (mean age 64.8 years, 82.1% men, average left ventricular ejection fraction, LVEF, 27.1%). At long-term follow-up (median time 70.4 months), total mortality was 40.8%, and 16.5% of patients had received at least one appropriate shock (3.12%/year). Inappropriate shock [odds ratio (OR) 1.93, 95% confidence interval (95% CI) 1.08-3.47; P = 0.027] and length of follow-up (1 year, OR 1.01, 95% CI 1.00-1.01; P = 0.0031) were associated with the occurrence of appropriate shock, whereas atrial fibrillation (OR 2.65, 95% CI 1.55-4.51, P < 0.001), length of follow-up (1-year OR 1.01, 95% CI 1.00-1.01, P < 0.001) and appropriate shock (OR 1.93, 95% CI 1.08-3.47, P = 0.027) were associated with the occurrence of inappropriate shock. Neither appropriate nor inappropriate shock independently increased mortality risk, whereas older age (hazard ratio 1.05; 95% CI 1.04-1.07; P < 0.001), atrial fibrillation (hazard ratio 2.25; 95% CI 1.67-3.02; P < 0.001) and lower LVEF (hazard ratio 0.97; 95% CI 0.94-0.99; P = 0.004) did., Conclusion: Incidence of shocks in real-world primary prevention ICD recipients might be lower than expected, and the association between ICD shocks and prolongation of survival is not as clear-cut as might be perceived. Further investigations from larger real-world samples are warranted., (Copyright © 2020 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Guidelines recommend angiotensin-converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARB) for treatment of heart failure with reduced ejection fraction (HFrEF), but these medications are underprescribed in clinical practice. We reviewed the records of HF patients receiving a first visit in a tertiary outpatient clinic from January 1st 2004 to May 31st 2015, and selected those with a serum creatinine concentration (sCr) available at both the first and last visit and < 3.5 mg/dL at baseline, and a left ventricular ejection fraction (LVEF) < 50% at the first visit. Of 570 eligible patients, 92 (16.1%) never received ACEi/ARB. Compared to ACEi/ARB users, never-users were older, more often women, had higher sCr and lower systolic blood pressure, were less commonly on beta-blocker, and had more frequently anemia. Current or prior cancer also tended to be more common in ACEi/ARB never-users. ACEi/ARB users displayed an improvement in LVEF by ≥ 10% of the baseline value more often than ACEi/ARB never-users (33.7% vs. 20.7%, respectively, P = 0.01), whereas no difference in percent variation of sCr levels was found between the two groups (8.2% vs. 3.1%, respectively; P = 0.13). Over a median follow-up of 56 months (range 1-137 months), 215 (37.7%) patients died. After multiple adjustments, ACEi/ARB never-use was associated with an almost twofold increased risk of all-cause mortality (HR 1.97, 95%CI 1.39-2.80). ACEi/ARB underuse in HFrEF is a standing issue with dramatic prognostic consequences. Efforts are needed to eliminate perceived contraindications to these drugs and ensure their implementation in real-life cardiology.

Aims: Myocardial perfusion and ischemia scores obtained from myocardial perfusion scintigraphy (MPS) have strong independent prognostic value in elderly individuals without known coronary artery disease (CAD). Herein we aimed to assess their independent diagnostic value and accuracy for CAD while considering different thresholds of myocardial ischemia., Methods: We estimated the summed rest score (SRS), summed stress score (SSS) and summed difference score (SDS) in 322 elderly individuals (mean age 72 ± 7 years, 68% men) who underwent coronary angiography following an MPS. Abnormal perfusion at stress was defined as an SSS greater than 3, and ischemia as an SDS of at least 2, and further categorized as mild (2-4), moderate (5-7) or severe (>7). Multivariate logistic regressions were used to establish the independent diagnostic value and accuracy of MPS parameters., Results: CAD was diagnosed in 182 individuals (56%). In multivariate analysis accounting for clinical variables associated with CAD including the Framingham risk score, both SRS [odds ratio (OR) 1.09, 95% confidence interval (CI) 1.01-1.18, P = 0.03] and SSS (OR 1.10, 95% CI 1.04-1.16, P = 0.0006) and SDS (OR 1.12, 95% CI 1.04-1.21, P = 0.003) were independently associated with CAD. An SSS greater than 3 was also independently associated with CAD (OR 2.51, 95% CI 1.43-4.39, P = 0.0013), whereas an SDS of 2 or greater was not (OR 1.62, 95% CI 0.89-2.93, P = 0.12), but only when at least 5 (OR 2.31, 95% CI 1.32-4.03, P = 0.003). The probability of CAD was proportional to the amount of myocardial ischemia in those with an SSS greater than 3, and lower and comparable in those with an SSS of at least 3 or an SSS greater than 3 with SDS of 1 or less (P = 0.19). Increasing the threshold of myocardial ischemia determined a decrease in sensitivity and increase in specificity of MPS for both diagnosis and severity of CAD., Conclusion: We established the diagnostic value and accuracy of continuous scores and thresholds of abnormal myocardial perfusion and ischemia previously validated in prognostic studies. Their more widespread use could potentially improve the diagnostic yield of coronary angiography in elderly individuals with suspected CAD.

Background: The quality of care provided to patients with cancer who are dying in hospital and their families is suboptimum. The UK Liverpool Care Pathway (LCP) for patients who are dying was developed with the aim of transferring the best practice of hospices to hospitals. We therefore assessed the effectiveness of LCP in the Italian context (LCP-I) in improving the quality of end-of-life care for patients with cancer in hospitals and for their family., Methods: In this pragmatic cluster randomised trial, 16 Italian general medicine hospital wards were randomly assigned to implement the LCP-I programme or standard health-care practice. For each ward, we identified all patients who died from cancer in the 3 months before randomisation (preintervention) and in the 6 months after the completion of the LCP-I training programme. The primary endpoint was the overall quality of care toolkit scale. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01081899., Findings: During the postintervention assessment, data were gathered for 308 patients who died from cancer (147 in LCP-I programme wards and 161 in control wards). 232 (75%) of 308 family members were interviewed, 119 (81%) of 147 with relatives cared for in the LCP-I wards (mean cluster size 14·9 [range eight to 22]) and 113 (70%) of 161 in the control wards (14·1 [eight to 22]). After implementation of the LCP-I programme, no significant difference was noted in the distribution of the overall quality of care toolkit scores between the wards in which the LCP-I programme was implemented and the control wards (score 70·5 of 100 vs 63·0 of 100; cluster-adjusted mean difference 7·6 [95% CI -3·6 to 18·7]; p=0·186)., Interpretation: The effect of the LCP-I programme in our study is less than the effects noted in earlier phase 2 trials. However, if the programme is implemented well it has the potential to reduce the gap in quality of care between hospices and hospitals. Further research is needed to ascertain what components of the LCP-I programme might be effective and to develop and assess a wider range of approaches to quality improvement in hospital care for people at the end of their lives and for their families., Funding: Italian Ministry of Health and Maruzza Lefebvre D'Ovidio Foundation-Onlus., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Background: Opioid consumption data in Italy have been widely studied. However, only aggregate data can be found in the published literature, and differences are expected by distribution setting (community pharmacies and hospitals). The aim of our paper is to analyse opioids sales trends in Italy in the decade 2000-2010, in an effort to explore such differences., Methods: Quarterly sales data of opioid medicinal products sold by wholesalers to both community pharmacies (retail) and to hospitals (non-retail) during the time period 2000-2010 were supplied by IMS Italy. Data were standardized using the Defined Daily Doses per day per 1000 inhabitants (DDDd/1000)., Results: Opioid sales have steadily increased during the time period considered going from 1.04 DDDd/1000 in 2000 to 4.9 in 2010 (+292%). Nonetheless relevant differences can be found both by distribution setting and drug type. In particular retail sales have increased by 286 % for WHO Step II opioids and by 575% for WHO Step III drugs, while non-retail sales have increased by 48% and 263%, respectively. In 2010, fentanyl and buprenorphine transdermal patches and oxycodone are more widely prescribed than morphine, in the retail setting, with fentanyl at large in the first position. In hospitals morphine and fentanyl almost equally share the 75% of the market., Conclusion: Data suggest that morphine is no more the opioid of first choice for severe pain in Italy, at least for outpatients. This is contradicting most international guidelines available in the 2000-2010 decade.

Background: Dealing with cancer pain implies assessing the intensity and other attributes of pain and identifying appropriate outcomes and endpoints to evaluate the effect of treatments., Methods: In the context of an observational longitudinal prospective study, 1461 painful cancer patients were evaluated at baseline and weekly over 4 weeks. Four pain intensity (PI) measures (worst, average, least and right now: WP, AP, LP, and PRN), pain relief and patients' satisfaction with pain treatments were recorded. Starting from these data, we extrapolated the full responder (FR) subjects, whose PI decreased by ≥2 points, or by ≥30%, or who obtained a final score of ≤5 points, according to criteria previously suggested by literature. The receiver operating characteristics (ROC) curve analysis was used to estimate the predictive accuracy., Results: All the PI measures decreased from the initial to final visit: the reduction was 1.9 as WP, 1.3, 0.8 and 1.2 as AP, LP and PRN, respectively. The proportion of FR differed from 47.8% to 88.3% depending on PI measures and the criterion adopted. ROC analysis showed an acceptable accuracy of all endpoints and confirmed the cut-offs recommended by the literature. The best criterion corresponded to a PI absolute value of ≤4 points when measured as AP., Conclusions: All measures applied seem able to profile the evolution of pain, with some differences. This implies the need of an appropriate choice of outcomes and endpoints according to the goal and objective of the intervention under evaluation., (© 2012 European Federation of International Association for the Study of Pain Chapters.)

Objectives: To describe our experience in the management of coronary artery anomalies both in an adult and in a paediatric population and to compare the two groups for finding out differences in terms of angiographic incidence and treatment., Patients and Methods: Databases at the Department of Cardiology of San Martino Adult's Hospital and of Gaslini Children's Hospital were searched for all patients with a diagnosis of coronary artery anomaly who underwent coronary angiography between 1994 and 2006., Results: Coronary anomalies were diagnosed in 76 (1%) adult patients. Anomalous left circumflex artery was the commonest coronary anomaly (25%). Anomalous left coronary artery from pulmonary artery and myocardial bridges were the only anomalies responsible for angina-like symptoms. No patients except the one with anomalous left coronary artery from pulmonary artery needed surgical intervention. In the paediatric population, we found 28 (0.9%) patients with coronary anomalies. Anomalous left coronary artery from pulmonary artery was the most common anomaly (48%) and always required emergency surgical treatment; in addition there were two patients with stenosis of the left main coronary artery., Conclusion: Coronary artery anomalies may be associated with very acute, even life-threatening symptoms in children, whereas they are usually clinically silent and detected by accident on coronary angiography in adults. Recognition of coronary artery anomalies enables early treatment or close follow-up in children, whereas it could be useful in case of cardiac surgery in adults.

Objectives: To evaluate whether the current European Association for Palliative Care recommendation regarding the starting dose of 5 mg of normal-release morphine (NRM) sulfate oral solution every 4 hours in opioid naive patients or 10 mg in patients already being treated with "weak" opioids is effective and could be proposed as starting routine dose in clinical practice. Secondary aims were to estimate the percentage of patients who were high responders to NRM and to study the association of baseline patient characteristics with both high analgesic responsivity and the need of opioid dose escalation., Methods: Consecutive strong opioid-naive patients with cancer pain were enrolled in a multicenter uncontrolled phase 4 clinical trial. Oral NRM was administered at 2 different dosages: 5 and 10 mg every 4 hours, respectively, for opioids-naive (group A) and nonopioids-naive (group B) patients as starting therapy. Average daily dosages of NRM and opioid escalation index (OEI) were calculated and the reduction in pain score was tested through Student t test both in group A and in group B patients., Results: One hundred fifty-nine consecutive patients were enrolled and data analysis was conducted on 151 (95%) patients. On an average the OEIs were: 3.2 in group A and 6.5 in group B and a significant reduction in pain score both after 3 and 5 days from baseline (P<0.001) was shown in both groups. In multivariate analysis both Karnofsky Performance Status and episodic pain showed to be independent prognostic factors of a high analgesic response. The presence of neuropathic pain showed to be associated with a higher OEI., Discussion: These data show that empiric standard doses of NRM during titration, recommended by European Association for Palliative Care, are effective in clinical practice.

Background: Screening of the oral cavity and dental care was suggested as mandatory preventive measures of osteonecrosis of the jaw (ONJ) in patients receiving bisphosphonates (BPs). We investigated the occurrence of ONJ before and after implementation of dental preventive measures when starting BP therapy., Patients and Methods: Since April 2005, 154 consecutive patients treated with BPs (POST-Group) have undergone a baseline mouth assessment (dental visit +/- orthopantomography of the jaws) to detect potential dental conditions and dental care if required. A retrospective review was also conducted of all consecutive cancer patients with bone metastases (PRE-Group) and treated for the first time with BPs from January 1999 to April 2005 in our clinic without receiving any preventive measure. Incidence proportion and incidence rate (IR) were used to estimate the incidence of ONJ., Results: Among the study population (966 patients; male/female=179/787), 73% had breast cancer. 25% of patients were given zoledronic acid (ZOL), 62% pamidronate (PAM), 8% PAM followed by ZOL and 5% clodronate. ONJ was observed in 28 patients (2.9%); we observed a reduction in the incidence of ONJ from 3.2% to 1.3%, when comparing-pre and post-implementation of preventive measures programme. Considering the patients exposed to ZOL, the performance of a dental examination and the application of preventive measures led to a sustained reduction in ONJ IR (7.8% in the PRE-Group versus 1.7% in the POST-Group; P=0.016), with an IR ratio of 0.30 (95% confidence interval 0.03-1.26)., Conclusions: ONJ is a manageable and preventable condition. Our data confirm that the application of preventive measures can significantly reduce the incidence of ONJ in cancer patients receiving BPs therapy. Dental exams combined to the identification of patients at risk in cooperation with the Dental Team can improve outcomes and increase the number of ONJ-free patients.

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.

The capability to make decisions about one's own dying and death is commonly considered a necessary component of a good death, but difficulties in communicating about imminent death have been documented. This paper attempts to describe the process of constructing an instrument to elicit individual preferences concerning dying, while respecting the patient's awareness, and to verify its applicability in a palliative care setting. The development of the End-of-Life Preferences Interview (ELPI) was performed through (a) a literature search aimed at identifying relevant issues; (b) examination by a panel of experts in the field of palliative care of the items generated; and (c) pretesting of feasibility on all eligible consecutive patients referred to three centers of palliative care during a two-month period. The final version of the ELPI consisted of two parts: The first level explores preferences about issues regarding the caregiving process, and the second level focuses on preparation for death. Each of the two parts is introduced by key questions aimed at allowing the patient to decide whether and when to stop exploring such sensitive matters. Among the 49 eligible patients (41%), the interview was proposed to only 13 of them (27%), and only one of them refused. The reasons for such a low compliance of physicians in proposing the ELPI were evaluated by a semi-structured interview and are herein discussed. The use of the ELPI in clinical practice can favor the passage to a greater consideration of the self-determination of the patient at the end of life, with due consideration of his or her cultural and emotional needs.

Objective: The aim of this study is to describe the last month of life of severely demented elders in long-term care institutions, and the clinical decisions in the management of their end-of-life events., Design: Retrospective exploratory study., Setting: Seven Italian long-term care institutions with more than 200 beds., Participants: One hundred forty-one patients with advanced (FAST stage = 7c) dementia (Alzheimer disease, vascular, other kinds of dementia, severe cognitive impairment)., Measurement: Diagnosis, Mini-Mental State Examination, cause of death. Data were collected from clinical and nursing records referring to the last 30 days of life: symptoms and signs, intensity and incidence, treatments (antibiotics, analgesics, anxiolytics, antidepressants, artificial nutrition/hydration, and use of restraints); the last 48 hours: cardiopulmonary resuscitation attempts and life-sustaining drugs., Results: Patients were given antibiotics (71.6%), anxiolytics (37.1%), and antidepressants (7.8%). Twenty-nine patients (20.5%) were tube- or percutaneous endoscopic gastrostomy (PEG)-fed. Most patients (66.6%) were also parenterally hydrated (72 intravenously, 15 by hypodermoclysis). Some form of physical restraint was used for 58.2% (bed-rails and other immobilizers). Almost half of the patients had pressure sores. In general, attention to physical suffering was fairly good, but during the last 48 hours a number of interventions could be considered inappropriate for these patients: tube feeding (20.5%), intravenous hydration (66.6%), antibiotics (71.6%), and life-sustaining drugs (34.0%)., Conclusions: Some indicators imply a less than optimal quality of care (restraints, pressure sores, psychoactive drugs, and the lack of documentation of shared decision-making) and suggest that far advanced demented patients are not fully perceived as "terminal."

Background: World Health Organization (WHO) guidelines, Agency for Health Care Policy and Research (AHCPR) clinical practice guidelines, and EAPC recommendations indicate oral route of opioid administration as the preferred route. Transdermal administration of opioids is considered an alternative when patients cannot take medications orally. Moreover, WHO and EAPC indicate orally administered morphine as the first-choice drug for the treatment of moderate to severe cancer-related pain. However, we can see that in Italy there is an increasing use of transdermal fentanyl (TF) as first-choice strong opioid (and route) even when oral administration of opioids is possible., Aims: The aims of this study are to describe the modality in the use of TF administration in two settings of care, taking into consideration (1) the drugs previously taken by the patients, (2) the reasons for switching from any drug to TF, (3) the conversion ratio used, and (4) the frequency of "inappropriate use of transdermal fentanyl according to the WHO guidelines and the EAPC recommendations", i.e., switching to fentanyl patch from any drug, even if there were no contraindications in using oral morphine. The settings of care considered were the out-patient palliative care unit (OP-PCU) and the oncological wards (OWs) of the National Cancer Institute (NCI) of Milan., Patients and Methods: The clinical charts of 98 patients prescribed with and given fentanyl patch for the first time at the NCI of Milan in 2002 were reviewed and the data gathered were grouped according to the administration of fentanyl at the OP-PCU (63 out-patients) or at the OWs (35 in-patients). Summary descriptive statistics and bar and box plots have been used. Fisher two-tailed exact text was applied to test the differences between in- and out-patients., Results: Before switching to TF, (1) in-patients were more frequently treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and weak opioids (mostly tramadol) in respect to the out-patients (44.1 vs 25.8%) who were mostly treated with oral morphine (48.4 vs 20.6%) (p=0.045), and (2) 88.7% of the out-patients were treated with oral opioids and only 1.6% with parenteral opioids in respect to OWs where 69.7% were on oral opioids and 18.2% on parenteral opioids (p=0.006). In 29% of out-patients and in 53% of in-patients, changing to fentanyl patch was considered as "inappropriate" (p=0.028) according to the WHO guidelines and the EAPC recommendations. No statistically significant differences between the two settings were observed regarding the reasons for switching and the conversion ratio used., Conclusions: There is a trend to use fentanyl patch as first-choice strong opioid in cancer patients in situations such as titration phase, in the presence of instable pain, and in the absence of dysphagia or gastrointestinal symptoms where the use of oral morphine is, however, not contraindicated.

Background: specific polymorphisms of genes regulating intracellular redox balance and oxidative stress are related to atherogenesis. Some studies have identified a relationship between progression of atherosclerosis and C242T mutation in CYBA gene coding for p22phox, a subunit of the NADH/NADPH oxidase system., Design: we investigated whether the C242T nucleotide transition is associated with the presence of coronary artery disease (CAD) in a population of 494 Caucasian Italians undergoing coronary angiography to diagnose the cause of chest pain., Results: the frequency of the T mutant allele that we found in 276 patients with angiographically documented CAD was significantly higher compared to what we observed in 218 subjects with normal coronary arteries (Controls) (respectively: 0.400 and 0.332, p<0.01). The prevalence of the T allele was even stronger when we compared: 1) early onset (age < or =55) vs late onset (age > or =65) single-vessel CAD patients (respectively: 0.75 and 0.48, p<0.05), and 2) the subgroup of CAD patients with at least one > or =98% stenosis in a coronary vessel vs those with no > or =98% stenosis in a coronary vessel (respectively: 0.425 and 0.365, p<0.05)., Conclusions: these results support the increased risk of developing early CAD and of having rapid progression of coronary stenosis in subjects carrying the C242T nucleotide transition among the Italian population.

In the palliative care setting, the Edmonton Symptom Assessment Scale (ESAS) was developed for use in daily symptom assessment of palliative care patients. ESAS considers the presence and severity of nine symptoms common in cancer patients: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath plus an optional tenth symptom, which can be added by the patient. The aim of this study was to validate the Italian version of ESAS and to evaluate an easy quality of life monitoring system that uses a patient's self-rating symptom assessment in two different palliative care settings: in-patients and home patients. Eighty-three in-patients and 158 home care patients were enrolled. In the latter group, the Italian validated version of the Symptom Distress Scale (SDS) was also administered at the admission of the patients. The two groups of patients have similar median survival, demographic and clinical characteristics, symptom prevalence and overall distress score at baseline. ESAS shows a good concurrent validity with respect to SDS. The correlation between the physical items of ESAS and SDS was shown to be higher than the correlation between the psychological items. The association of ESAS scores and performance status (PS) showed a trend: the higher the symptom score was, the worse was the PS level. Test-retest evaluation, applied in the in-patient group, showed good agreement for depression, well-being and overall distress and a moderate agreement for all the other items. In conclusion, ESAS can be considered a valid, reliable and feasible instrument for physical symptom assessment in routine "palliative care" clinical practice with a potentially different responsiveness in different situations or care settings.

To describe how patients die in hospital, 370 patients (age >18 years; in hospital for>24 hours) who died on the general wards of 40 Italian hospitals were assessed. Differences between patients whose death was expected and patients whose death was unexpected were evaluated. Data on treatments and care in proximity of death were collected after interviewing the nurse responsible for the patient within 72 hours of the patient's death, and from clinical and nursing records. For 58% of patients, death was highly expected. Symptom control was inadequate for the most severely ill patients: 75% experienced at least one "severe" symptom (42% pain and 45% dyspnea). Nurses tended to judge patients' global care as "good" or "very good" (76%), in spite of the persistence of symptoms and the scant use of analgesics. Despite some encouraging signs of sensitivity to end-of-life problems, acute inpatient institutions in Italy still deal inadequately with the needs of dying persons.

Accurate pain assessment is considered essential for effective management of cancer pain. The aim of this study was to evaluate the compliance of hospitalized patients with chronic cancer pain, referred to an inpatient palliative care consultation service, with self-assessment of pain intensity by means of a daily pain form. The form was distributed daily by the pain consult nurse and required three daily pain intensity measurements on 0 to 10 numerical scales, separately for pain at rest and pain on movement. Of 174 consecutive patients, 106 (61%) participated in the study and were followed up for a median of 10.6 days (range 1-32 days). Compliance was defined as the number of assessment forms completed over the number of evaluation days available for each patient. Mean compliance was 58%. The main reasons for not completing the form were related to subjective psychological variables (44%), physical distress (26%), and absence of pain (16%). Lack of understanding of the method was reported as the main reason for non-compliance by only 1% of patients.

In the last few years, palliative care for advanced and terminal cancer patients has undergone considerable evolution. We determined the characteristics of patients admitted to the 4-bed Palliative Care Unit (PCU) of the National Cancer Institute (NCI) of Milan in 1987, 1993 and 2000 to evaluate how our diagnostic and therapeutic approaches have changed over the years. We reviewed the charts of every patient admitted to the PCU in 1987, 1993, and the first ten months of 2000. We recorded demographic data; the primary tumor sites; the main reason for admission; the types of therapies administered (oncologic, analgesic, surgical, neurosurgical analgesic procedures, and supportive therapy); the type and number of cardiological, radiological and endoscopic examinations, as well as specialist consultations; the duration of stay and eventual death on the Unit. There were no significant differences regarding gender, age, primary tumor site and death in hospital of the patients admitted during these years. The time spent in hospital increased over time (P = 0.006). A significant increase was observed in the percentage of patients admitted for supportive therapy (P < 0.001) and investigation concerning the stage of the disease (P < 0.001). There was a significant decrease in admission for invasive analgesic procedures (P < 0.001), as well as for pain diagnosis and/or uncontrolled pain. Uncontrolled pain remained the most frequent reason for admission. Over the years, during hospitalization, 7% to 12% of the patients underwent radiotherapy,1% to 9% had computerized tomography, and 4% to 8% had palliative surgery. More than 50% of the patients received intravenous hydration; a few patients received hypodermoclysis in 1987. Over time, there was a significant increase in "as needed" administration of nonsteroidal anti-inflammatory drugs and a significant reduction in their regular administration (from 24% in 1987 and 1993 to 3% in 2000) (P < 0.001). The use of codeine, tramadol and methadone increased (P < 0.001), whereas the use of oral morphine, buprenorphine and oxycodone decreased in 2000 (P < 0.001). There was a reduction in the use of antidepressants (no significant constant trend) and a significant increase in the use of anticonvulsants, laxatives and pamidronate (P < 0.001). Regularly administered hypnotics decreased in 1993 and increased in 2000 (P < 0.001). Over these years, no significant differences were found in the routes of opioid administration, in route switching and in the mean maximum oral opioid dose (ranging from 108 to 126 mg/day). The percentage of patients undergoing percutaneous cordotomy significantly decreased in 1993 and 2000 (P < 0.001). Over time, there was an increase in requests for specialist consultations, which was significant for neurological, cardiological and oncological consults (P < 0.001). Although the characteristics of the patients admitted to the PCU did not change over these years, there have been significant modifications in our therapeutic approaches, above all in the use of supportive therapy, adjuvant drugs, opioids and neurosurgical invasive procedures. Moreover, a major collaborative interaction with other specialists of the NCI took place with the aim to tailor treatment for each single patient.

According to the data of the literature, the prevalence of pain in cancer patients at various stages of the disease and the settings of care range from 38 to 51%, with an increase of up to 74% in the advanced and terminal stages. Despite published World Health Organization (WHO) guidelines for pain management, 42 to 51% of cancer patients receive inadequate analgesia and 30% receive no analgesics at all. A 3-year Research Project "Towards a Pain-free Hospital", which began one year ago, is ongoing at the National Cancer Institute of Milan. The research is organized in three subsequent steps. In the 1st one, a series of patient- and staff-oriented evaluation tools are used to assess the level of appropriateness of pain communication, assessment, management and control of the in-patients. The 2nd step will implement a number of continuing educational interventions aimed at improving patient awareness and staff knowledge of the appropriate pain assessment and management in order to respond to the patient's pain problem. In the 3rd step, all the assessment tools used in step one will be applied again to establish the prevalence of pain, the causes and intensity and patient satisfaction with pain management and to evaluate the impact of the interventions performed during the 2nd step regarding the overall ability of our hospital to tackle pain emergency in the hospitalized cancer population. The results relative to the 1st step are herein reported, in particular as regards the study on prevalence, causes, severity of pain, the interference of pain with sleep, mood and concentration, the use of pain medications and the relief obtained, the structural validity and internal consistency of the assessment tool used. A total of 258 patients hospitalized for at least 24 h were interviewed by 9 physicians using a brief structured questionnaire prepared ad hoc: 51.5% of the patients presented pain during the previous 24 h caused by surgery (49.6%) or by the tumor mass itself (29.3%). Out of the 133 patients with pain, a high degree (much or very much) of pain at rest was present in 27.1% and pain on movement in 30.8%; 31.6% did not take any analgesic treatment, and 14.3% of the latter reported a high degree of pain at rest and 21.4% on movement. Pain interfered with sleep from much to very much in 28.8% and with irritability and nervousness in 15.9% of the patients. In the 91 patients taking analgesics, 57.2% reported a high degree of pain relief. A high degree of pain and interference, however, was associated with low relief levels. The assessment tool used was shown to have a good structural validity and internal consistency (Chrombach alpha index of interference scale = 0.73). Although the Milan Cancer Institute has the longest tradition in Italy of pain assessment by means of validated tools and pain management according to the WHO guidelines and educational efforts in this field, the results of the study clearly show that it is necessary to persevere with continuing educational and informative programs in order to reduce the frequency and severity of pain and thus improve the quality of life of in-patients.

Background: At present, abdominoperineal resection remains the most diffuse method of treatment of very low rectal cancer. Today, we can avoid this method in some patients by using a sphincter-saving procedure., Methods: From March 1990 to January 1999, 273 consecutive total rectal resections and coloendoanal anastomoses were performed at our Institute; this study concerns 141 consecutive patients treated for a primary adenocarcinoma of the distal rectum, from 3.5 to 8 cm from the anal verge. Patient stratification, based on definitive pathological report, was 31 Dukes' stage A (T2N0), 44 stage B (T3N0), and 66 stage C (T2N+-T3N+)., Results: Overall recurrence rate was 9.2%; postoperative morbidity attributable to the procedure was low. A perfect continence was documented in 61% of cases. The only pathological factor related to local recurrence rate is peritumoral lymphocytic reaction inside and around the tumor (P = .0005 and .031) independently from the number of metastatic lymph nodes, depth of fatty tissue infiltration, and lymphatic and venous neoplastic emboli. The minimum follow-up time is 12 months., Conclusions: Our data, in accordance with other authors, seem to highlight the relevant role that a well-practiced surgery, together with accurate information on the spreading of this disease, has in achieving an optimal local control of cancer.

Background: In the last 10 years of clinical research there has been increasing interest in the evaluation of quality of life. Several generic and specific instruments have been developed for this purpose. EORTC QLQ C-30 is a cancer-specific questionnaire translated into various languages and validated in several European countries including Italy, where the impact of malignant disease on different areas of quality of life is poorly documented., Methods: The EORTC QLQ C-30 was administered to 109 patients referred to the endoscopy division of the Istituto Nazionale Tumori, Milan, for endoscopic palliative treatment of malignant dysphagia to test its characteristics in terms of acceptability and clinical validity., Results: In this group of patients the impact of advanced esophageal cancer was highly evident for Emotional and Physical Functioning, Fatigue and Global QoL scales. Dysphagia is a serious problem for many patients; there is a correlation between grade of dysphagia and four QoL dimensions., Conclusions: QoL assessment is an important tool to evaluate the adequate management of patients with esophageal cancer. The EORTC QLQ-C30 questionnaire proved to be valid and reliable also in this population.

This study describes the characteristics of a representative sample of terminally ill cancer patients at admission to Italian palliative care programs, the rate and reasons for discontinuation of care, and survival after enrollment. All Italian palliative care units (PCUs) specifically committed to palliative care were asked to consecutively register all new patients (n = 3901) between January and June, 1995. Fifty-eight of the 62 PCUs contacted by the Steering Committee completed the study. A random sample of 589 evaluable patients was prospectively selected from the 2667 eligible patients. Patients were mostly referred by a general practitioner (31.2%) or a specialist (42.1%). Most patients (84.7%) were followed until death. Seventy-seven discontinued care because of hospital admission (6.6%), change of residence (3.9%), refusal (1.7%), or improvement (0.8%). Median survival was 37.9 days; 14.3% of the patients died within 7 days, and 15.3% lived longer than 180 days. A statistically significant association between survival and gender, cancer type, setting of the first visit, and type of unit was observed. In Italy, as in other countries with different health systems, referral of cancer patients to palliative care tends to occur late in the course of the disease. This study suggests that the process of enrollment and the duration of patients' survival in palliative care, when studied in large unselected populations, can provide important information relevant to the care of terminally ill patients.

As part of a large multicentre study on palliative care units in Italy, carried out between 1 January and 30 June 1995, we describe the place, circumstances and 'quality of death' of patients admitted to home palliative care. Data presented refer to 401 patients (67% of the 601 patients randomly selected for evaluation). Of these 401 patients 303 (76%) died at home. According to the Support Team Assessment Schedule (STAS) pain was fairly well controlled during the final week of life, while the control of other symptoms appeared to be less satisfactory. Invasive procedures were undertaken on 56% of patients, while in hospital the percentage increased to 75%. Twenty-five per cent of patients were totally pharmacologically sedated during the final 12 h of life. Neither the number of symptoms nor other factors were apparently associated with the decision to sedate the patient. The wide variations in the frequency of sedation among centres suggest that the choice to sedate the patient may reflect the provider's behaviour or services' policy rather than the patients' preference or needs. The definition of common criteria and guidelines for sedation of patients should be one of the topics for discussion among palliative care teams.

Patients with unstable angina fall into a wide prognostic and therapeutic spectrum but, in general, have great access to specialty care and invasive procedures. In the modern era, in which admissions for unstable angina outnumber those for myocardial infarction, and growing economic pressures are placed on health care systems, cardiologists must re-examine clinical strategies for treating unstable angina in the light of health-cost accounting. The aims of the present study were to examine the current management of patients admitted to our cardiology department and to calculate the medical costs. A patient schedule was drawn up to prospectively register the number and type of cardiac processes carried out during hospitalization for all unstable angina patients in the period between March 1st and May 30th, 1995. Time (minutes) actually spent by both physicians and nurses for each cardiac process were carefully recorded in order to calculate the activity budget. The effective economic budget was built for each cardiac process taking into account salaries, consumable supplies, equipment service contracts, depreciation and indirect medical and non medical costs for CCU and ward. Based to the Diagnosis Related Groups (DRG) system, 53 out of 318 patients (16%) were admitted with documented or suspected unstable angina and allocated to discharge into four DRGs: DRG 140-medically treated unstable angina: 18 patients; DRG 124-unstable angina with angiography: 16 patients; DRG 122-unstable angina evolving in myocardial infarction: 6 patients; DRG 112-unstable angina with angioplasty: 13 patients. The mean cost for hospitalized patient with unstable angina was 5,574,958 Italian Liras (DRG 140 = 2,687,719; DRG 124 = 2,800,347; DRG 122 = 6,086,563; DRG 112 = 12,751,454). The difference in costs was essentially related to the procedures involved in medical care, DRGs with expensive cardiac processes having higher costs. Furthermore, these data show a deep discrepancy between "real" costs and current DRG reimbursement. In conclusion, data show the standard management of unstable angina at our center; calculating the true costs of unstable angina is the first step towards maximizing resources and optimizing benefits.

Background: The problems related to requests for euthanasia by terminal patients; the variations in attitude of palliative care physicians and the possibility that availability of the best palliative care might obviate the problem by eliminating requests for euthanasia, are under discussion., Design: A mailed survey with no possibility of follow-up of all 685 physician members of the Italian Society for Palliative Care (SICP) in 1994., Results: Of the 359 (52.4%) responders, 139 (39%) had received requests for euthanasia; 16 of them (4% of the responders but 11.5% of those who received requests) had complied at least once, while 216 (60%) had not; 125 (35%) thought that euthanasia was 'wrong' under all circumstances; 115 (32%) thought that situations could occur, even in the context of palliative care, in which euthanasia might be ethically 'correct'; 185 (52%) thought that the best palliative care might solve the problem of euthanasia, while 109 (30%) believed otherwise. The variable most strongly associated with a negative attitude toward euthanasia and with the opinion that the best palliative care might be a solution to the problem is religious belief (P < 0.0001)., Conclusions: The attitudes of physicians practising palliative care in Italy are not different from those reported by previous studies which investigated the attitude of other health professionals. There was no agreement about whether the best palliative care might reduce requests for euthanasia by terminal patients.

This study presents a prospective evaluation of the home care programme for patients with advanced cancer at the National Cancer Institute of Milan. Demographic, psychosocial and physical variables were evaluated. The Therapy Impact Questionnaire was used for symptom and quality of life assessment. The association of clinical and demographic variables with the place of death was investigated, considering that the aim of the home care programme is to follow up patients until death in their houses. Eighty-six per cent (86%) of patients died at home and 14% in hospitals. Multivariate analysis showed that only a higher degree of family support was associated with home death. Several changes in symptoms and quality of life items scores were seen, pain improved while physical debility and cognitive functions worsened throughout the home care duration to death. High intensity pain and dyspnoea were still present in, respectively, 23.8 and 15.3% of patients in the last week of life. Psychological distress was high at the end of life and did not seem to be affected by treatment. Home care is a feasible alternative for implementing palliative care in a selected population of patients with advanced cancer. Palliation of physical symptoms is more easily achieved than the control of psychological suffering. Family and economical issues implied by home care models should be part of the discussion in implementing palliative care for advanced cancer patients.

To evaluate long-term prognosis during medical treatment of hypertension associated with angina pectoris, a total of 1083 patients with angiographically-documented coronary artery disease were followed for a mean of 66 months. At the end of the study, follow-up was complete in 98% of all patients. Of the 1083 patients, 132 (12%) had hypertension and 951 (88%) were not hypertensive. During the follow-up period, there was a total of 15 deaths (11.3%) among the hypertensive population (vs. 61 or 6.4% in the nonhypertensives) as well as a higher incidence of nonfatal myocardial infarction (9.0% in the hypertensives vs. 3.7% in the nonhypertensives) (Figure 2). Six-year cumulative survival was 84% in the hypertensive patients as compared to 92% in the nonhypertensives. Among risk factors, historical data, clinical and catheterization findings, the only noninvasively-obtainable independent predictor of prognosis using multivariate analysis was hypertension (Table 3).