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.

[Caring pathways of terminal cancer patients: a retrospective survey]. / I percorsi assistenziali del malato oncologico terminale: uno studio retrospettivo.

Caring pathways of terminal cancer patients: a retrospective survey. Introduction. The caring patways of terminal cancer patients of the Vallagarina district, dead in 2008, cared at home and/or by district services in the last 90 days of life of cancer patients, were retrospectively described. Aim. To describe the last 90 days of life of all patients dead for cancer. Methods. Data were collected from different sources: hospital discharge forms, local health unit informative systems, data bank of the palliative care service (PC), charts of PC and home care services and through interviews to caregivers, for patients cared by General practitioners (GPs). Results. Four caring pathways were identified: patients mainly cared by GPs, in nursing homes, in long term care or by the PC service. The rate of hospital admissions varies widely: 25% of potential days of care for GPs patients; 1.3% for PCs patients; same for length of hospital stay: mean duration 18.7 days for GPs and 5.6 days for PC patients. Only rarely the GPs activate other forms of care such as care by multidisciplinary teams (10.8% patients) or visits at home by GPs (12.7% patients). Caregivers would like more information on the clinical situation of the patient and on the different caring services, to be involved in the decision making process. Conclusions. Patients cared by GPs and PC Service experience different caring pathways. Lack of information to caregivers may profoundly impact the type of care received.

[A double blind randomised clinical trial to assess the efficacy of the treatments of the superficial pressure sores]. / Studio clinico randomizzato controllato in doppio cieco sull'efficacia dei trattamenti delle lesioni da decubito.

In spite of the progresses of knowledge and care, pressure sores continue to be a clinically relevant problem. A double blind randomised controlled trial was organised to assess the efficacy of triticum vulgaris (Fitostimoline) vs placebo in the re-epithelisation of superficial pressure sores. Patients with stage NPUAP II or superficial pressure sores, with an expected survival of more than 3 months and eligible for a follow-up up to 8 weeks were included, over a period of 2 years in 46 clinical sites. The protocol was approved by local ethical committees and informed consent was obtained before randomisation. Medications were performed by nurses if the patient was hospitalised and by nurses or properly instructed caregivers at home. Weekly follow-up controls were assumed by nurses. Out of the 294 randomised patients 270 were included in the analyses. The two groups are comparable for the main characteristics except for Norton Scale mean values, less severe in the group assigned to active treatment (10.1+/-3.7 vs 8.9+/-3.2). The mean follow-up was of 3.8 and 4.2 weeks with a mean duration of 26+/-18 and 29+/-18 days for the experimental group and controls respectively. Seventy-six patients in the treatment group and controls (58.0 and 54.7) had their lesions re-epithelized. Adjusting results for age, initial Norton and Push scores there are no differences between treated and controls (OR 0.99 95% IC 0.60-1.67). This multicentre study, sponsored by a research group of nurses, failed to support the hypothesis that triticum vulgaris, the active component of the product Fitostimoline, given on top of recommended treatment, provides a specific therapeutic advantage in terms of frequency and timing of re-epithelization in superficial pressure sores.

[The participation in a clinical trial on pressure ulcer as an opportunity for education]. / La partecipazione allo studio sulle lesioni da decubito come opportunità di formazione.

Participating to a clinical trial is not a common experience for nurses involved in the care of chronic patients. The experiences, reflections and lessons learnt by a group of nurses involved in the PARI study, a double blind randomised clinical trial on the efficacy of treatment of pressure sores are reported. The main problems and obstacles in participating to the study (asking informed consent to the patients; the organization of an 8 weeks follow up) are analysed. The overall impression is that the participation to a clinical trial improves the quality of care and knowledge of the patients and of the problems studied.