Patients with irreversible malignant and non-malignant diseases have comparable mortality rates, symptom burdens, and quality of life issues; however, non-cancer patients seldom receive palliative care (PC) or receive it late in their disease trajectory. To explore the characteristics of non-cancer patients receiving PC in northern Italy, as well as the features and outcomes of their care, we retrospectively analyzed the charts of all non-cancer patients initiating PC regimens during 2019 in three publicly funded PC departments in Italy’s populous Lombardy region. We recorded the baseline variables (including data collected with the NECPAL CCOMS-ICO-derived questionnaire used since 2018 to evaluate all admissions to the region’s PC network), as well as treatment features (setting and duration) and outcomes (including time and setting of death). Of the 2043 patients admitted in 2019, only 12% (243 patients—131 females; mean age 83.5 years) had non-oncological primary diagnoses (mainly dementia [n = 78], heart disease [n = 55], and lung disease [n = 30]). All 243 had Karnofsky performance statuses ≤ 40% (10–20% in 64%); most (82%) were malnourished, 92% had ≥2 comorbidities, and 61% reported 2–3 severe symptoms (pain, dyspnea, and fatigue). Fifteen withdrew or were discharged from the study PCN; the other 228 remained in the PCN and died in hospice (n = 133), at home (n = 9), or after family-requested transfer to an emergency department (n = 1). Most deaths (172/228, 75%) occurred <3 weeks after PC initiation. These findings indicate that the PCN network we studied cares for few patients with life-limiting non-malignant diseases. Those admitted have advanced-stage illness, heavy symptom burdens, low performance statuses, and poor survival. Additional efforts are needed to improve PCN accessibility for non-cancer patients.

Purpose The aim of the present work was to evaluate the knowledge and prescriptive habits of clinicians involved in the management of chronic non cancer pain (CNCP), with a special focus on the use of opioids. Methods A Delphi method was used. A Board of specialists elaborated and discussed a series of statements, based on available literature and personal clinical expertise, about particularly controversial topics on pain pathophysiology and treatment. A Panel of experts in the field of pain management, selected by the Board, was invited to vote the proposed statements, indicating the level of agreement on a 5-point Likert scale (1: strongly disagree; 2: disagree; 3: partially agree; 4: agree; 5: strongly agree). The threshold for consensus was set at minimum 66.6% of the number of respondents with a level of agreement ≥4 (Agree or Strongly agree). Results The Board included 5 pain therapists, 1 pharmacologist and 1 methodology expert and drew up a total of 36 statements (for a total of 40 requested answers)”. A total of 100 clinicians were included in the Expert Panel. Respondents were 89 (89%). Consensus was achieved for 32 out of 40 answers. Most of the lack of consensus was recorded for statements regarding opioids use, and resulted from a low level of agreement (3 on the Likert scale), suggesting a neutral position deriving from a lack of knowledge rather than a strong contrary opinion. Conclusion Most of the proposed items reached consensus, suggesting a generally homogeneous approach to CNCP management. However, the lack of consensus recorded for several items regarding opioid use confirms the need to fill important gaps in the knowledge of available agents. A clear explanation of the peculiar pharmacological properties of drugs associated with potential clinical advantages (such as buprenorphine) will help optimize pain treatment in both primary care and hospital settings and improving pain control in CNCP patients.

Dyspnea can be assessed using self-rating scales but, as death approaches, self-reporting becomes difficult. The validated Respiratory Distress Observation Scale measures dyspnea distress. The aim of this study was to develop the Italian version of the Respiratory Distress Observation Scale and to examine its psychometric properties. This was a cross-sectional study, analyzing cultural and linguistic validation, content validity, and psychometric properties. Eighty-nine palliative care subjects were enrolled to validate the Italian version of the Respiratory Distress Observation Scale. Patients had an average age of 74.5 (SD, 11.6) years, and 52% (n = 46) were female. Fourteen experts in palliative care evaluated the Italian Respiratory Distress Observation Scale in terms of the content validity ratio and the content validity index (CVI). The Italian Respiratory Distress Observation Scale was reported with an internal consistency (Cronbach α value) of .72 and an overall substantial interrater reliability (Cohen κ method). The Italian Respiratory Distress Observation Scale achieved a scale-level CVI of 93%, an items-level CVI of greater than 86%, and a minimum content validity ratio value of 0.71. A weak positive correlation was found between the Respiratory Distress Observation Scale and the Dyspnea Visual Analog Scale scores (0.374; P < .001). The Italian Respiratory Distress Observation Scale showed good reliability and validity for patients in palliative care. The Respiratory Distress Observation Scale measured respiratory distress in patients nearest to death.

Context. The Cancer Dyspnea Scale (CDS) is a self-reported multidimensional tool used for the assessment of dyspnea, a subjective experience of breathing discomfort, in patients with cancer. The scale describes dyspnea using three distinct factors: physical, psychological, and discomfort at rest. Objectives. To crossculturally validate the Italian version of CDS (CDS-IT) and examine its content validity, feasibility, internal consistency, and construct validity in patients with advanced cancer. Methods. A cross-sectional study was conducted. CDS-IT was forward-backward translated, and its content was validated among a group of experts. Cronbach's a coefficients were used to assess the internal consistency. Construct validity was examined in terms of structural validity through confirmatory factor analysis, and convergent validity was examined with Visual Analogue Scale Dyspnea through the Pearson's correlation coefficient (r). Cancer Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care) and Italian Palliative Outcome Scale were also tested. Results. The CDS-IT was crossculturally validated and showed satisfactory content validity. A total of 101 patients (mean age = 76 [SD = 12]; 53% females) were recruited in palliative care settings. CDS-IT reported a good internal consistency in the total score and its factors (a = 0.74-0.83). The factor analysis corresponded acceptably but not completely with the original study. CDS-IT strongly correlated with Visual Analogue Scale Dyspnea (r = 0.68) and moderately with Italian Palliative Outcome Scale and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care (r = 0.33-0.36, respectively). Conclusion. The study findings supported the crosscultural validity of the CDS-IT. Its feasibility, internal consistency, and construct validity are satisfactory for clinical practice. The CDS-IT is available to health care professionals as a useful tool to assess dyspnea in patients with cancer. (C) 2020 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Dyspnea can be assessed using self-rating scales but, as death approaches, self-reporting becomes difficult. The validated Respiratory Distress Observation Scale measures dyspnea distress. The aim of this study was to develop the Italian version of the Respiratory Distress Observation Scale and to examine its psychometric properties. This was a cross-sectional study, analyzing cultural and linguistic validation, content validity, and psychometric properties. Eighty-nine palliative care subjects were enrolled to validate the Italian version of the Respiratory Distress Observation Scale. Patients had an average age of 74.5 (SD, 11.6) years, and 52% (n = 46) were female. Fourteen experts in palliative care evaluated the Italian Respiratory Distress Observation Scale in terms of the content validity ratio and the content validity index (CVI). The Italian Respiratory Distress Observation Scale was reported with an internal consistency (Cronbach α value) of .72 and an overall substantial interrater reliability (Cohen κ method). The Italian Respiratory Distress Observation Scale achieved a scale-level CVI of 93%, an items-level CVI of greater than 86%, and a minimum content validity ratio value of 0.71. A weak positive correlation was found between the Respiratory Distress Observation Scale and the Dyspnea Visual Analog Scale scores (0.374; P < .001). The Italian Respiratory Distress Observation Scale showed good reliability and validity for patients in palliative care. The Respiratory Distress Observation Scale measured respiratory distress in patients nearest to death.

PURPOSE:A large proportion of patients with cancer suffer from breakthrough cancer pain (BTcP). Several unmet clinical needs concerning BTcP treatment, such as optimal opioid dosages, are being investigated. In this analysis the hypothesis, we explore with an unsupervised learning algorithm whether distinct subtypes of BTcP exist and whether they can provide new insights into clinical practice.METHODS:Partitioning around a k-medoids algorithm on a large data set of patients with BTcP, previously collected by the Italian Oncologic Pain Survey group, was used to identify possible subgroups of BTcP. Resulting clusters were analyzed in terms of BTcP therapy satisfaction, clinical features, and use of basal pain and rapid-onset opioids. Opioid dosages were converted to a unique scale and the BTcP opioids-to-basal pain opioids ratio was calculated for each patient. We used polynomial logistic regression to catch nonlinear relationships between therapy satisfaction and opioid use.RESULTS:Our algorithm identified 12 distinct BTcP clusters. Optimal BTcP opioids-to-basal pain opioids ratios differed across the clusters, ranging from 15% to 50%. The majority of clusters were linked to a peculiar association of certain drugs with therapy satisfaction or dissatisfaction. A free online tool was created for new patients' cluster computation to validate these clusters in future studies and provide handy indications for personalized BTcP therapy.CONCLUSION:This work proposes a classification for BTcP and identifies subgroups of patients with unique efficacy of different pain medications. This work supports the theory that the optimal dose of BTcP opioids depends on the dose of basal opioids and identifies novel values that are possibly useful for future trials. These results will allow us to target BTcP therapy on the basis of patient characteristics and to define a precision medicine strategy also for supportive care.

Background: The aim of this study was to identify potential variables influencing the clinical presentation of breakthrough cancer pain (BTP). Methods: Cancer patients with a diagnosis of BTP were enrolled. Demographic and clinical characteristics, as well as background pain and BTP characteristics were collected. Multivariate analyses were conducted to assess the correlation between BTP characteristics and the variables examined. Results: Data of 4016 patients were analysed. Average daily number of BTP episodes was 2.4, mean intensity was 7.5, and a mean duration was 43.3 min. A short onset BTP was observed in 68.9% of patients. In 30.5% of patients BTP was predictable. There were 86.0% of participants who reported a marked interference of BTP with their daily activities. Furthermore, 86.8% of patients were receiving opioids for the management of BTP. The average time to meaningful pain relief was 16.5 min and 70.9% of patients were satisfied with their BTP medications. Age, head and neck cancer, Karnofsky, background pain intensity, predictable and fast onset BTP were independently associated with the number of BTP episodes. BTP pain intensity was independently associated with background pain intensity, fast onset BTP, and Karnofsky. Neuropathic pain mechanism was independently associated with unpredictable BTP. Variables independently associated with a longer duration of BTP were age, place of visit, cancer diagnosis, disease-oriented therapy, background pain intensity and mechanism, and unpredictable BTP. Age, Karnofsky, background pain intensity, fast onset, and long duration of BTP were independently associated with interference with daily activity. Conclusions: BTP has a variable presentation depending on interdependent relationships among its different characteristics.

BACKGROUND:Spinal cord stimulation (SCS) is a well-known treatment in patients with failed back surgery syndrome (FBSS). Burst stimulation is a recently developed stimulation modality that seems to be superior to tonic stimulation.METHODS:This observational multicenter study compared tonic and burst stimulation during a trial period in patients with FBSS or radiculopathy. All the patients enrolled underwent two weeks of tonic stimulation followed by another two weeks of BurstDR stimulation, without randomization. The primary outcome was the reduction of pain in the legs and back. Health-related quality of life (EQ-5D) and the pain catastrophizing scale (PCS) were assessed before and after the trial. Patients were reevaluated after 12 months.RESULTS:We recruited 23 patients, 57% of whom had FBSS and 43% had radiculopathies. Five patients failed both the tonic and burst stimulation trials. While tonic stimulation reduced leg pain (p < 0.05), the burst mode added an extra pain reduction (ΔNRS 1.2 ± 1.5) (p < 0.01). No significant reduction in back pain was found (p 0.29). Pain on movement was reduced only by BurstDR (p < 0.01). Both stimulation modalities increased EQ-5D and reduced PCS from the baseline (p < 0.0001). At the end of the SCS trial phase, 26% patients chose tonic SCS, while 74% preferred burst. On 12-month follow-up examination, the benefits recorded at the end of the trial were maintained.CONCLUSIONS:Burst stimulation confers a greater reduction in leg pain intensity at rest and on movement. Reducing axial pain is still a challenge. Further studies are needed in order to provide each patient with the most appropriate stimulation paradigm.

An ongoing national multicenter survey [Italian Oncologic Pain multiSetting Multicentric Survey (IOPS-MS)] is evaluating the characteristics of breakthrough cancer pain (BTP) in different clinical settings. Preliminary data from the first 1500 cancer patients with BTP enrolled in this study are presented here.

The use of opiates at high doses in cancer pain can cause the appearance of side effects such as constipation, drowsiness, disorientation, and sometimes phenomena of addiction without assurance of adequate pain relief. The treatment of side effects with targeted therapies or with the rotation of opiates is not always effective; in these cases it is necessary to reduce the dose of the opioid that determines a further worsening of the pain symptoms. The subarachnoid route of administration through a completely programmable flow-implanted pump represents a valid therapeutic alternative for the management of clinical cases which are further complicated by the use of opiates at high dosage for refractory pain.

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.