[STOPPFrail version 2: a tool for deprescription in medicine, validated in Italian language.] / Strumenti a supporto della deprescrizione in medicina: la versione italiana dello STOPPFrail2.

OBJECTIVE: Deprescribing, i.e. the suspension of drugs whose existing or potential harms outweigh the benefits in the context of care for the individual patient, is an increasingly frequently encountered topic in various congresses today. This issue becomes predominant especially in patients with chronic pathologies with a life expectancy of less than a year, in whom the goal of the treatments passes from healing to caring. Currently there are few validated deprescribing tools, one of these is certainly the STOPPFrail, currently available in its second version. Therefore, we decided to provide for the translation into Italian, to make the description for the elderly patient with limited life expectation more applicable. METHODS: For the translation, we used the method expressed by the European organisation for research and treatment of cancer (Eortc), using forward-backward translation and a Pilot Testing to verify the clarity and comprehensibility of the translation itself. RESULTS: We interviewed 15 experts, of whom 13 responded and completed the evaluation, without bringing to light any unclear sections or sources of misunderstanding. CONCLUSIONS: STOPPFrail2 can be a valid deprescribing tool in the elderly with limited life expectancy; the Italian version can help the physicians in the therapeutic appropriateness in this time of life where it is necessary to focus on the quality of life and on the ethical aspect of the choices, as well as being of help in a "cost-opportunity" logic.

Genetic Factors Associated With Pain Severity, Daily Opioid Dose Requirement, and Pain Response Among Advanced Cancer Patients Receiving Supportive Care.

BACKGROUND: Current understanding of genetic factors associated with pain severity, and improvement of pain with opioids in advanced cancer patients (AC) is inadequate for delivery of personalized pain therapy (PPT). Therefore, the aim of this study was to determine the genetic factors associated with pain severity, daily opioid dose, and pain response in AC patients receiving supportive care. METHODS: In this prospective study, AC patients were eligible if they had cancer pain ≥4/10 on Edmonton Symptom Assessment Scale (ESAS) - Pain Item and needed opioid rotation for pain control by specialist at the outpatient supportive care center. Association of genetic factors with pain phenotype was assessed using logistic regression models and SKATO (Gene-block) analysis. RESULTS: About 174/178 (98%) patient samples were analyzed. After adjustment for demographic and clinical variables, pain severity was negatively associated with intron variant alleles in OPRM1 rs9322446, P = 0.02; rs2270459, P = 0.038; rs62052210, P = 0.038. Opioid daily dose was positively associated NFKBIA rs2233419, P = 0.008; rs2233417, P = 0.007; rs3138054, P = 0.008; rs1050851, P = 0.015; ORPM1 rs9479759, P = 0.046; rs2003185, P = 0.047; rs636433, P = 0.044; COMT (rs9306234, P = 0.014; rs165728, P = 0.014; rs2020917, P = 0.036; rs165728, P = 0.034); ARRB2 (rs1045280, P = 0.045); and pain response to opioids was negatively associated OPRM1 rs1319339, P = 0.024; rs34427887, P = 0.048; and COMT rs4646316, P = 0.03; rs35478083, P = 0.028, respectively. SKATO analysis showed association between pain severity and CXCL8 (P = 0.0056), and STAT6 (P = 0.0297) genes respectively, and pain response with IL-6 (P = 0.00499). CONCLUSIONS: This study identified that SNPs of OPRM1, COMT, NFKBIA, CXCL8, IL-6, STAT6, and ARRB2 genes were associated with pain severity, opioid daily dose, and pain response in AC receiving supportive care. Additional studies are needed to validate our findings for PPT.

Validity, reliability and responsiveness to change of the Italian palliative care outcome scale: a multicenter study of advanced cancer patients.

BACKGROUND: There is an increasing requirement to assess outcomes, but few measures have been tested for advanced medical illness. We aimed to test the validity, reliability and responsiveness of the Palliative care Outcome Scale (POS), and to analyse predictors of change after the transition to palliative care. METHODS: Phase 1: multicentre, mixed method study comprising cognitive and qualitative interviews with patients and staff, cultural refinement and adaption. Phase 2: consecutive cancer patients on admission to 8 inpatient hospices and 7 home-based teams were asked to complete the POS, the EORTC QLQ-C15-PAL and the FACIT-Sp (T0), to assess internal consistency, convergent and divergent validity. After 6 days (T1) patients and staff completed the POS to assess responsiveness to change (T1-T0), and agreement between self-assessed POS and POS completed by the staff. Finally, we asked hospices an assessment 24-48 h after T1 to assess its reliability (test re-test analysis). RESULTS: Phase I: 209 completed POS questionnaires and 29 cognitive interviews were assessed, revisions made and one item substituted. Phase II: 295 consecutive patients admitted to 15 PCTs were approached, 175 (59.3 %) were eligible, and 150 (85.7 %) consented. Consent was limited by the severity of illness in 40 % patients. We found good convergent validity, with strong and moderate correlations (r ranged 0.5-0.8) between similar items from the POS, the QLQ-C15-PAL and the FACIT-Sp. As hypothesised, the physical function subscale of QLQ-C15-PAL was not correlated with any POS item (r ranged -0.16-0.02). We found acceptable to good test re-test reliability in both versions for 6 items. We found significant clinical improvements during the first week of palliative care in 7/10 items assessed-pain, other symptoms, patient and family anxiety, information, feeling at peace and wasted time. CONCLUSIONS: Both the patient self-assessed and professional POS versions are valid and with an acceptable internal consistency. POS detected significant clinical improvements during palliative care, at a time when patients are usually expected to deteriorate. These results suggest that there is room for substantial improvement in the management of patients with advanced disease, across all key domains-symptoms, psychological, information, social and spiritual.

Effectiveness of complex interventions focused on quality-of-life assessment to improve palliative care patients' outcomes: a systematic review.

BACKGROUND: One of the most crucial palliative care challenges is in determining how patient' needs are defined and assessed. Assessing quality of life has been defined as a priority in palliative care, and it has become a central concept in palliative care practice. AIM: To determine to what extent interventions focused on measuring quality of life in palliative care practice are effective in improving outcomes in palliative care patients. DESIGN: Systematic review according to the recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and hand searches. DATA SOURCES: MEDLINE, CINAHL, EMBASE, PsycINFO, and the Cochrane Library were searched for articles published until June 2012, and through hand searching from references lists of included articles. Only studies that included adult palliative care patients, in any palliative care clinical practice setting of care, and with an experimental, quasi-experimental, or observational analytical study design were eligible for inclusion. All studies were independently reviewed by two investigators who scored them for methodological quality by using the Edwards Method Score. RESULTS: In total, 11 articles (of 8579) incorporating information from 10 studies were included. Only three were randomized controlled trials. The quality of the evidence was found from moderate to low. Given a wide variability among patients' outcomes, individual effect size (ES) was possible for 6 out of 10 studies, 3 of which found a moderate ES on symptoms (ES = 0.68) and psychological (ES = 0.60) and social (ES = 0.55) dimensions. CONCLUSION: Effectiveness of interventions focused on quality-of-life assessment is moderate. Additional studies should explore the complexity of the real palliative care world more accurately and understand the effects of independent variables included in complex palliative care interventions.

Factors associated with fulfilling the preference for dying at home among cancer patients: the role of general practitioners.

AIM: This study aimed to explore clinical and care-related factors associated with fulfilling cancer patients' preference for home death across four countries: Belgium (BE), The Netherlands (NL), Italy (IT), and Spain (ES). METHODS: A mortality follow-back study was undertaken from 2009 to 2011 via representative networks of general practitioners (GPs). The study included all patients aged 18 and over who had died of cancer and whose home death preference and place of death were known by the GP. Factors associated with meeting home death preference were tested using multivariable logistic regressions. RESULTS: Among 2,048 deceased patients, preferred and actual place of death was known in 42.6 percent of cases. Home death preference met ranged from 65.5 to 90.9 percent. Country-specific factors included older age in BE, and decision-making capacity and being female in the NL. GPs' provision of palliative care was positively associated with meeting home death preference. Odds ratios (ORs) were: BE: 9.9 (95 percent confidence interval [CI] 3.7-26.6); NL: 9.7 (2.4-39.9); and IT: 2.6 (1.2-5.5). ORs for Spain are not shown because a multivariate model was not performed. CONCLUSION: Those who develop policy to facilitate home death need to examine available resources for primary end-of-life care.

The Liverpool Care Pathway for cancer patients dying in hospital medical wards: a before-after cluster phase II trial of outcomes reported by family members.

BACKGROUND: Hospital is the most common place of cancer death but concerns regarding the quality of end-of-life care remain. AIM: Preliminary assessment of the effectiveness of the Liverpool Care Pathway on the quality of end-of-life care provided to adult cancer patients during their last week of life in hospital. DESIGN: Uncontrolled before-after intervention cluster trial. SETTINGS/PARTICIPANTS: The trial was performed within four hospital wards participating in the pilot implementation of the Italian version of the Liverpool Care Pathway programme. All cancer patients who died in the hospital wards 2-4 months before and after the implementation of the Italian version of Liverpool Care Pathway were identified. A total of 2 months after the patient's death, bereaved family members were interviewed using the Toolkit After-Death Family Interview (seven 0-100 scales assessing the quality of end-of-life care) and the Italian version of the Views of Informal Carers - Evaluation of Services (VOICES) (three items assessing pain, breathlessness and nausea-vomiting). RESULTS: An interview was obtained for 79 family members, 46 (73.0%) before and 33 (68.8%) after implementation of the Italian version of Liverpool Care Pathway. Following Italian version of Liverpool Care Pathway implementation, there was a significant improvement in the mean scores of four Toolkit scales: respect, kindness and dignity (+16.8; 95% confidence interval = 3.6-30.0; p = 0.015); family emotional support (+20.9; 95% confidence interval = 9.6-32.3; p < 0.001); family self-efficacy (+14.3; 95% confidence interval = 0.3-28.2; p = 0.049) and coordination of care (+14.3; 95% confidence interval = 4.2-24.3; p = 0.007). No significant improvement in symptom' control was observed. CONCLUSIONS: These results provide the first robust data collected from family members of a preliminary clinically significant improvement, in some aspects, of quality of care after the implementation of the Italian version of Liverpool Care Pathway programme. The poor effect for symptom control suggests areas for further innovation and development.

Liverpool Care Pathway for patients with cancer in hospital: a cluster randomised trial.

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.

The Ligurian high-school educational project on palliative care: development and piloting of a school-based intervention on bereavement and severe illness.

This study was aimed at developing and piloting a school-based intervention on severe illness-induced bereavement through a project focused on spreading knowledge of palliative care among high school students (phases 0-II Medical Research Council Framework). The intervention entailed the screening of a topic-related movie and a classroom meeting. Eight classes from 2 high schools participated, and a before-after evaluation was used to assess intervention feasibility and impact. Valid questionnaires, including 2 open-ended questions focusing on bereavement and strategies for coping with loss, were filled in by 89% (before) and 84% (after) of the 159 students. In the after evaluation, content analysis on the "strategies" question showed that answers concerning closeness and sharing were reported more frequently. Positive feedback was collected as regards the overall experience.

Awareness of general practitioners concerning cancer patients' preferences for place of death: evidence from four European countries.

BACKGROUND: General Practitioners (GPs) are at the first level of contact in many European healthcare systems and they supposedly have a role in supporting cancer patients in achieving their desired place of death. A four-country (Belgium, the Netherlands, Italy and Spain) study was carried out exploring current practices. PATIENTS AND METHODS: EURO SENTI-MELC adopted a retrospective study design and data for this study were collected in 2010 through representative GPs' networks in four countries. In the current study all non-sudden cancer deaths were included with weekly GP registrations. RESULTS: The main study sample included 930 deceased cancer patients: preference for place of death was known by GPs for only 377. GP awareness on the preferred place of death varied across countries, 27% in Italy, 36% in Spain, 45% in Belgium and 72% in the Netherlands (p<0.01). The general level of preferences met was high, from 68% (Italy) to 92% (Spain). CONCLUSIONS: Despite the importance of being able to die in a preferred location, GPs were often unaware about patient preferences, especially in Italy and Spain. If GPs were informed, the preference was often met in all countries, indicating room for improvement in end-of-life care.

Does quality of life assessment in palliative care look like a complex screening program?

BACKGROUND: Palliative Care (PC) is an approach that improves the Quality of Life (QoL). A number of QoL assessment tools have been developed and validated in PC. It is not clear how QoL should be measured in PC practice. A procedure of QoL assessment in clinical practice can be defined as a clinical intervention focused on QoL assessment. This is a typical complex intervention that should be appropriately developed and described in all its components and assessed for its effectiveness. The aim of this study is to define a framework to help researchers to develop and evaluate clinical interventions focused on QoL assessment in PC. METHODS: A study group of experts in PC and in research methodology was set up to define a framework that would describe the principles of clinical interventions focused on QoL assessment in PC. The study group discussed the WHO Population Screening Principles as a possible useful framework. The new principles had to be developed taking into account the following criteria: 1) specific to PC practice; 2) address a single underlying characteristic; 3) anchored to relevant literature; 4) consistent with the WHO PC definition.With regard to contents and the format of the principles, discussions occurred among the study group members through a cognitive process. RESULTS: We reviewed each of the WHO Population Screening Principles and adapted them to QoL assessment, taking into account the defined criteria. As a result, a new framework, the QoL Assessment Principles in Palliative Care was developed. It consisted of 4 sections, for a total of 11 principles. CONCLUSIONS: The WHO Screening Principles framework was used to outline the eleven essential principles to be considered in developing and/or evaluating clinical interventions focused on QoL assessment in PC. The QoL Assessment Principles in Palliative Care identified could represent a methodological and ethical standard to be considered when developing and evaluating a clinical intervention focused on QoL assessment in PC.

Survey of Italian general practitioners: knowledge, opinions, and activities of palliative care.

CONTEXT: General practitioners (GPs) play a key role in the end-of-life care of patients; however, currently in Italy, there are no national population-based studies available of the knowledge and activities of GPs in palliative care. OBJECTIVES: This survey aimed to investigate the knowledge, opinions, and activities of Italian GPs regarding palliative care. METHODS: A telephone survey of 1690 GPs was performed. Information was gathered through an ad hoc questionnaire. RESULTS: Valid interviews were obtained for 88% of the sampled GPs (n=1489). Regarding knowledge, 25% of GPs recognized a correct definition of palliative care, 41% the objectives of palliative care, 66% that palliative care should be provided by a multiprofessional team including GPs, and 60% that in-home care for patients at the end of life requires an individual plan care. Furthermore, 92% of them reported that "there is no maximum daily morphine dose for the management of pain." Regarding opinions, most of the GPs strongly agreed that for patients at the end of life, the GPs' duties included availability during working hours to break bad news to patients and families and to collaborate with the multiprofessional team in establishing an individual care plan. Finally, regarding activities, most GPs reported that, in their daily practice with patients at the end of life, they discontinue the drugs that are not beneficial to symptom management and seek advice from palliative care physicians when symptom management is ineffective. CONCLUSION: This survey reveals the uncertainty of GPs regarding many theoretical issues but a strong willingness to integrate with the multiprofessional palliative care team. To further enhance the skills of GPs and facilitate the collaboration with palliative care services, it might be useful to realize ad hoc training schemes tailored to the different organizational procedures of in-home palliative care services.

Quality indicators for care of cancer patients in their last days of life: literature update and experts' evaluation.

BACKGROUND: Quality indicators (QIs) are needed to monitor and to improve palliative care. Care of patients in the last days of life is a discrete phase of palliative care and therefore specific QIs are needed. This study aimed to identify and evaluate current QIs against which to measure future care of patients in the last days of life. METHODS: To identify QIs for patients in the last days of life an update of the literature and national guidelines was conducted. Subsequently, an international panel of palliative care experts was asked to evaluate the identified QIs: how well they describe care and how applicable they are for care in the last days of life. Also additional QIs were asked. RESULTS: In total, 34 QIs for care in the last days were identified in the literature and guidelines. The experts (response rate 58%) agreed with seven QIs as being good descriptors and applicable: concerning a home visit for the family following a patient's death, the presence of a dedicated family room, limited patients receiving chemotherapy, limited need for pain control, gastrointestinal symptoms, and communication from professional to patient and family. The experts also suggested 18 additional topics for QIs for the last days of life. CONCLUSION: Currently no definite set of QIs exist to describe quality of care of patients in their last days of life. New QIs that are focused on care for patients in their last days of life, their relatives, as well as their professional caregivers are needed.

[Improving quality of end-of-life care. A possible and necessary change]. / Migliorare la qualità delle cure di fine vita. Un cambiamento possibile e necessario.

This article describes the phases of development and assessment of a continuous quality improvement program focused on hospital end-of-life care for cancer patients. Although most patients would like to die at home, a high proportion still die in hospital. Many studies showed non appropriate end-of-life care for patients dying in hospital and their families. During the last years, a number of hospital end-of-life pathways have been developed but only partially assessed. Among the different care pathways the most structured and proficient seems to be the Liverpool Care Pathway for the dying patient (LCP). Although it is currently in use in over 20 countries, evidence for its effectiveness are weak. The Medical Research Council framework has been used for designing the process of implementation and assessment of the Italian LCP Program for cancer patients dying in hospital. In the first step (preclinical and phase I) results from literature review have been used to develop the Italian version of the Program. Subsequently, LCP-I Program has been piloted in the Medical and Respiratory Disease wards of the "Villa Scassi Hospital" of Genoa by a Palliative Care Team (phase I-II). The implementation process has been assessed with a mixed model. Focus groups, performed on samples of doctors and nurses before and after the implementation of the LCP-I, showed a perception of effectiveness of the Program, particularly in pain management and in communication with patients and their families. Quantitative analyses, performed on consecutive series of cancer deaths before and after the introduction of the Program, allowed to test process and outcomes measures for assessing the quality of end-of-life care. According to the results from the previous phases, a cluster randomised trial was designed with the aim of assessing the effectiveness of the LCP-I Program in improving quality of end-of-life care (phase III). This study is ongoing and final results will be available by 2012. In conclusion, development and assessment of the LCP Program in Italy shows that it is possible to perform studies aimed at assessing complex interventions in end-of-life care.

Methodological issues in a before-after study design to evaluate the Liverpool Care Pathway for the Dying Patient in hospital.

BACKGROUND: In 2006, as the first step of a 3-year research programme to assess the Liverpool Care Pathway for the Dying Patient (LCP) in hospital, the original LCP documentation was translated and piloted in four Italian hospital wards in Genoa. The primary aim was to evaluate the feasibility of LCP implementation in the Italian context. The secondary aim of the study was to evaluate the effectiveness of the LCP with an uncontrolled before-after design. AIM: The aim of the study was to discuss and critically evaluate the methodological issues in designing and interpreting the results of the before-after study design. SETTING/PARTICIPANTS: All cancer deaths which occurred in four hospital wards (three general medicine and one respiratory disease) 4 months before and 4 months after LCP implementation (2 months for the respiratory disease ward) were registered. Caregivers were interviewed after the patient's death using the Toolkit After-Death Bereaved Family Member Interview. RESULTS: A total of 111 cancer deaths were identified (63 before and 48 after) and 79 caregivers (71.2%) were interviewed (46 before and 33 after). The analyses on number and characteristics of the patients, interviewed caregivers, compliance and modality of assessment showed significant differences before and after. A remarkable internal correlation coefficient for all of the Toolkit scales within the four hospital wards was observed. CONCLUSIONS: This analysis confirms the high risk of selection and information bias inherent the uncontrolled before- after study design. The high internal correlation strongly suggests that clustering should be taken into account in this kind of study.

The effectiveness of the Liverpool care pathway in improving end of life care for dying cancer patients in hospital. A cluster randomised trial.

BACKGROUND: 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. METHODS AND DESIGN: 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". DISCUSSION: 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 TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01081899.

End-of-life care in Italian hospitals: quality of and satisfaction with care from the caregivers' point of view--results from the Italian Survey of the Dying of Cancer.

CONTEXT: A number of studies have highlighted the poor quality of end-of-life (EOL) care provided in hospital settings, leading to a reduction in the quality of EOL care and increase in patient and caregiver dissatisfaction levels. OBJECTIVES: The aims of this study were the evaluation of the prevalence of major symptoms, treatment, outcomes, information, and care provided to dying cancer patients in Italian hospitals; and an analysis of clinical and socio-demographic factors associated with caregiver satisfaction with the health care provided. METHODS: This is a mortality follow-back survey of 2,000 cancer deaths representative of the country. Caregivers were interviewed about patients' experiences by using a tailored version of the View of Informal Carers-Evaluation of Services questionnaire. RESULTS: Valid interviews were obtained for 84% (n=364) of the cancer patients who died in hospital. Most Italian cancer patients dying in hospital suffered from a number of untreated or poorly treated symptoms, and only a few reported an acceptable control over physical suffering. Moreover, only two-thirds of patients and one-third of caregivers received basic information on therapies and care. About one-third of the caregivers expressed dissatisfaction with the health care received. The probability of being satisfied was more likely for caregivers of patients living in the north of Italy; caregivers of patients who had not experienced or were only slightly distressed by fatigue; and caregivers who were generally satisfied with hospital facilities and when the health care professionals had provided appropriate information to both patients and caregivers. CONCLUSION: This study revealed poor quality of EOL care in Italian hospitals, with almost one-third of the caregivers expressing their clear dissatisfaction. A national policy is, therefore, urgently called for to improve the quality of EOL care in Italian hospitals.

Evaluation of a screening programme for psychological distress in cancer survivors.

PURPOSE: This study is aimed at evaluating the feasibility of a screening procedure for psychological distress in cancer survivors. METHODS: Consecutive series of 339 cancer patients from three centres were requested to fill in two questionnaires measuring psychological distress (PDI) and social support (MOSS). Psychological intervention was offered to patients with significant degree of distress. RESULTS: Most patients accepted to be screened (72.0%; n = 244), and a subgroup (16.0%) showed high psychological distress. A higher ratio of distressed patients was observed among those with lower social support (P = 0.017). A significant (P < 0.01) negative correlation between psychological distress and social support was observed. A psychological intervention was offered to patients with high psychological distress, but only 15.6% completed it. CONCLUSIONS: Results from this study provide both some insights into the characteristics of psychological distress and some input on issues that may arise when implementing a screening procedure for psychological distress in cancer survivors. Further research is needed to assess both the clinical significance of distress and the most appropriate tools to carry out screening procedures within the target population.

Health services research on end-of-life care.

PURPOSE OF REVIEW: To summarize and discuss recent research aimed at evaluating palliative care services, and other complex interventions in end-of-life care. RECENT FINDINGS: Innovative approaches for the evaluation of complex interventions are highly relevant in end-of-life care. The Medical Research Council Framework for the development and evaluation of complex interventions uses the classic approach to research for drug development, but with a wider range of study methods, including experimental. This approach has been used in some recent research and has proved useful for the evaluation of effectiveness of palliative care services. Moreover, during recent years some experimental studies have explored feasibility, effectiveness and costs of complex programs to improve the quality of end-of-life care. Finally, the effectiveness of population-based educational interventions has been shown by one study focused on the preferences and attitudes on end-of-life care. SUMMARY: Health services research is crucial in end-of-life care because of the complex services and patients and families cared for. Health services research can provide information about the most effective (and cost-effective) strategies to improve the quality of end-of-life care. During recent years some interesting research and study protocols dealing with the evaluation of complex end-of-life programs have been designed and implemented.

Cancer trajectories at the end of life: is there an effect of age and gender?

BACKGROUND: Few empirical data show the pattern of functional decline at the end of life for cancer patients, especially among older patients. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

End-of-life care in Italy: personal experience of family caregivers. A content analysis of open questions from the Italian Survey of the Dying of Cancer (ISDOC).

OBJECTIVE: This study aims at describing the emotional and practical experience of a representative sample of Italian non-professional caregivers when caring for a terminally ill family member and is part of the 'Italian Survey of the Dying of Cancer', which involved 2000 adult cancer deaths representative of the whole country. METHODS: Information on patients' experience was gathered from non-professional caregivers by an interview. A specific question was asked about the caregivers' emotional and practical experiences while assisting a terminally ill relative. A content analysis of the open question on caregivers' perceptions was performed on transcribed answers. Three researchers independently generated categories. Subsequently, areas where they differed were reconsidered and an interpretation was agreed upon. RESULTS: Valid interviews were obtained from 1231 non-professional caregivers. Answers were classified according to the perception of the experience as positive (33.1%), negative (65.1%) or neutral (1.8%). CONCLUSION: Assisting a family member with cancer in his/her last three months of life is a very strong physical and mental stress for the caregiver. In some cases, this experience is nevertheless perceived as an evolution chance. Health-care providers should need to develop programs to ensure that family caregivers' needs for information and support are given great importance.