title: Validity, reliability and responsiveness to change of the Italian palliative care outcome scale: a multicenter study of advanced cancer patients.
abstract: 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.
authors.affiliation: Palliative Care Unit, Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy. costantini.massimo@asmn.re.it.
authors.forename: Massimo
authors.initials: M
authors.lastname: Costantini
authors.affiliation: Palliative Care Unit, Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Rabitti
authors.affiliation: Academy of Sciences of Palliative Medicine, Bentivoglio, Bologna, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Beccaro
authors.affiliation: Palliative Care Unit, ASL3 Genovese, Genoa, Italy.
authors.forename: Flavio
authors.initials: F
authors.lastname: Fusco
authors.affiliation: Palliative Care Unit, Biella Hospital, Biella, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Peruselli
authors.affiliation: Palliative Care Unit, ASL CN1, Cuneo, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: La Ciura
authors.affiliation: FARO Foundation, Turin, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Valle
authors.affiliation: Palliative Care, Distretto Vallagarina, Trento, Italy.
authors.forename: Cinzia
authors.initials: C
authors.lastname: Suriani
authors.affiliation: Psycho-Oncology Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
authors.forename: Maria Alejandra
authors.initials: MA
authors.lastname: Berardi
authors.affiliation: Palliative Care Network, AUSL, Bologna, Italy.
authors.forename: Danila
authors.initials: D
authors.lastname: Valenti
authors.affiliation: Palliative Care Unit, ASL TO 4, Turin, Italy.
authors.forename: Felicita
authors.initials: F
authors.lastname: Mosso
authors.affiliation: Convento delle Oblate Hospice, Azienda Sanitaria, Florence, Italy.
authors.forename: Piero
authors.initials: P
authors.lastname: Morino
authors.affiliation: Hospice Domus Salutis, Fondazione Teresa Camplani, Brescia, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Zaninetta
authors.affiliation: Hospice ASL 1 Imperiese, Sanremo, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Tubere
authors.affiliation: S. Felice a Ema Hospice, Azienda Sanitaria, Florence, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Piazza
authors.affiliation: Palliative Care Unit, Garbagnate, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Sofia
authors.affiliation: Psycho-Oncology Unit, Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Di Leo
authors.affiliation: Department of Palliative Care, Policy and Rehabilitation, Cicely Saunders Institute, King's College London, London, UK.
authors.forename: Irene J
authors.initials: IJ
authors.lastname: Higginson
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000067290:Behavior Rating Scale / Q000592:standards*; D005260:Female; D006801:Humans; D007558:Italy; D007802:Language; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000523:psychology; D017063:Outcome Assessment, Health Care; D010166:Palliative Care / Q000523:psychology*; D011788:Quality of Life; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires