Palliative medicine favourably influences end-of-life cancer care intensity: a large retrospective database study.

OBJECTIVES: Hospice and home palliative care have been associated to a reduction of aggressive treatments in the end-of-life, but data in the Italian context are scanty. Therefore, we aim to investigate the role of palliative care on indicators of end-of-life intensity of care among patients with cancer in Lombardy, the largest Italian region. METHODS: Within a retrospective study using the healthcare utilisation databases of Lombardy, Italy, we selected all residents who died in 2019 with a diagnosis of cancer. We considered as exposure variables admission to palliative care and time at palliative care admission, and as indicators of aggressive care hospitalisations, diagnostic/therapeutic procedures, in-hospital death, emergency department visits and chemotherapy over a time window of 30 days before death; chemotherapy in the last 14 days was also considered. RESULTS: Our cohort included 26 539 individuals; of these, 14 320 (54%) were admitted to palliative care before death. Individuals who were admitted to palliative care had an odds ratio (OR) of 0.27 for one hospitalisation, 0.14 for ≥2 hospitalisations, 0.25 for hospital stay ≥12 days, 0.38 for minor diagnostic/therapeutic procedures, 0.18 for major diagnostic/therapeutic procedures, 0.02 for in-hospital death, 0.35 for one emergency department visit, 0.29 for ≥2 emergency department visits and 0.66 for chemotherapy use in the last 30 days; the OR was 0.56 for chemotherapy use in the last 14 days. CONCLUSIONS: This large real-world analysis confirms and further support the importance of palliative care assistance for patients with cancer in the end- of- life; this is associated to a significant reduction in unnecessary treatments.

[Palliative Care in Lombardy Region: analysis of the care offer in 2019.] / Le cure palliative in Lombardia: analisi dell'offerta assistenziale nel 2019.

OBJECTIVE: The Lombardy Region has one of the most widespread and advanced models of Palliative Care (PC) in the country. However, there is a relative lack of updated data referring to the activity of the Lombardy PC network. METHODS: This work aims to describe the activity carried out in the two main PC care settings (home care and hospice) in 2019 through the analysis of the data sent by each Unit to the Lombardy Region. Data were analysed on a regional basis and considering the 8 Health Protection Agencies (ATS) separately. RESULTS: In 2019, PC activity was provided by 114 home care units (1.14/100,000 inhabitants) and 70 hospice for a total of 812 beds (8.1 beds/100,000 inhabitants). Overall, 25,514 patients were assisted for a total of 29,892 care pathway. 77.6% of the patients assisted were oncologic and about 67% of the patients who died of cancer in Lombardy were intercepted by CP. 54.4% of patients were taken care of in home care, although with a significant difference between cancer patients (58%) and non-cancer patients (42%). In home care, average activation time was 2.8 days and in 81% of cases the assistance was activated within 24-48 hours; in hospice, average activation time was 3.5 days, with 60% of admissions within 24 hours and over 30% with waiting time ≥3 days. The median duration of home palliative care was approximately 21 days (average 40.5), that in hospice was 9 days (average 17.2). In the home care pathways, the prevalent outcome was the death of the patient at home (64%) and hospitalization in hospice (17.2%), while 86% of hospitalizations in hospice ended with death. CONCLUSIONS: This accurate report of the Lombardy PC activity indicates that PC satisfy various qualitative indicators of structural and care process identified by national regulations. However, PC still remain predominantly intended for cancer patients, with relatively short duration of care, particularly in the hospice setting.

Benefits in pain perception, ability function and health-related quality of life in patients with failed back surgery syndrome undergoing spinal cord stimulation in a clinical practice setting.

BACKGROUND: Failed back surgery syndrome (FBSS) represents one main cause of chronic neuropathic or mixed pain, functional disability and reduced Health Related Quality of Life (HRQoL). Spinal Cord Stimulation (SCS) can be a value for money option to treat patients refractory to conventional medical management (CMM). We estimated from real-world data: 1) the amount of reduced levels of HRQoL of target patients compared to general population, 2) the relationship between pain intensity, functional disability, and overall HRQoL, and 3) the improvement of patients' health from SCS intervention, and 4) we give some insights and make some suggestions on the selection of a battery of patients' reported health instruments for use in routine clinical practice. METHODS: At recruitment (before SCS) and every 6 months for 2 years after SCS a battery of questionnaires/tests were completed: the generic EQ-5D and SF-36 for HRQoL, the specific Numerical Rating Scale (NRS) to measure pain intensity, and Oswestry Disability Index (ODI) to measure functional disability. We conducted multilevel regression analyses to investigate the association of HRQoL with the NRS and ODI indexes; multiple regression analyses to compare EQ-5D data with those of the general population adjusted for age, sex and education, and statistical tests to compare the changes of HRQoL, NRS and ODI estimates at baseline with those measured during the follow-up. RESULTS: Eighty patients (40% male, mean age = 58 years) participated. HRQoL was significantly worse in the patients than in the corresponding general population. Pain, functional disability and HRQoL significantly related each other during follow-up, Significant improvements (p < 0.001) in pain intensity, functional capability and HRQoL were reached after 6 months from SCS and generally remained stable during follow-up. Specific instruments provided detailed information on disability and pain, while generic instruments assessed the overall HRQoL and allowed a comparison with the general population's one. CONCLUSIONS: SCS + CMM treatment reaches a statistically significant and probably a clinically relevant improvement in pain perception, functional disability and HRQoL in patients with FBSS refractory to CMM. An appropriate selection of instruments for use in clinical practice is crucial for a routine assessment of health perception in patients, aimed to guide decisions for optimal treatment.

Cost-Effectiveness and Cost-Utility Analysis of Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome: Results From the PRECISE Study.

OBJECTIVE: To assess the cost-effectiveness and cost-utility of Spinal Cord Stimulation (SCS) in patients with failed back surgery syndrome (FBSS) refractory to conventional medical management (CMM). MATERIALS AND METHODS: We conducted an observational, multicenter, longitudinal ambispective study, where patients with predominant leg pain refractory to CMM expecting to receive SCS+CMM were recruited in 9 Italian centers and followed up to 24 months after SCS. We collected data on clinical status (pain intensity, disability), Health-Related Quality-of-Life (HRQoL) and on direct and indirect costs before (pre-SCS) and after (post-SCS) the SCS intervention. Costs were quantified in € 2009, adopting the National Health Service's (NHS), patient and societal perspectives. Benefits and costs pre-SCS versus post-SCS were compared to estimate the incremental cost-effectiveness and cost utility ratios. RESULTS: 80 patients (40% male, mean age 58 years) were recruited. Between baseline and 24 months post-SCS, clinical outcomes and HRQoL significantly improved. The EQ-5D utility index increased from 0.421 to 0.630 (p < 0.0001). Statistically significant improvement was first observed six months post-SCS. Societal costs increased from €6600 (pre-SCS) to €13,200 (post-SCS) per patient per year. Accordingly, the cost-utility acceptability curve suggested that if decision makers' willingness to pay per Quality-Adjusted-Life-Years (QALYs) was €60,000, SCS implantation would be cost-effective in 80% and 85% of cases, according to the NHS's and societal point of views, respectively. CONCLUSIONS: Our results suggest that in clinical practice, SCS+CMM treatment of FBSS patients refractory to CMM provides good value for money. Further research is encouraged in the form of larger, long-term studies.

The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation.

OBJECTIVE: After randomizing 100 failed back surgery syndrome patients to receive spinal cord stimulation (SCS) plus conventional medical management (CMM) or CMM alone, the results of the 6-month Prospective Randomized Controlled Multicenter Trial of the Effectiveness of Spinal Cord Stimulation (i.e., PROCESS) showed that SCS offered superior pain relief, health-related quality of life, and functional capacity. Because the rate of crossover favoring SCS beyond 6 months would bias a long-term randomized group comparison, we present all outcomes in patients who continued SCS from randomization to 24 months and, for illustrative purposes, the primary outcome (>50% leg pain relief) per randomization and final treatment. METHODS: Patients provided data on pain, quality of life, function, pain medication use, treatment satisfaction, and employment status. Investigators documented adverse events. Data analysis included inferential comparisons and multivariate regression analyses. RESULTS: The 42 patients continuing SCS (of 52 randomized to SCS) reported significantly improved leg pain relief (P < 0.0001), quality of life (P

Quality of life, resource consumption and costs of spinal cord stimulation versus conventional medical management in neuropathic pain patients with failed back surgery syndrome (PROCESS trial).

BACKGROUND: Chronic back and leg pain conditions result in patients' loss of function, reduced quality of life and increased costs to the society. AIMS: To assess health-related quality of life (HRQoL) and cost implications of spinal cord stimulation plus non-surgical conventional medical management (SCS group) versus non-surgical conventional medical management alone (CMM group) in the management of neuropathic pain in patients with failed back surgery syndrome. METHODS: A total of 100 patients were randomised to either the SCS or CMM group. Healthcare resource consumption data relating to screening, the use of the implantable generator in SCS patients, hospital stay, and drug and non-drug pain-related treatment were collected prospectively. Resource consumption was costed using UK and Canadian 2005-2006 national figures. HRQoL was assessed using the EuroQol-5D (EQ-5D) questionnaire. Costs and outcomes were assessed for each patient over their first 6-months of the trial. RESULTS: The 6-month mean total healthcare cost in the SCS group (CAN$19,486; 12,653 euros) was significantly higher than in the CMM group (CAN$3994; 2594 euros), with a mean adjusted difference of CAN$15,395 (9997 euros) (p<0.001). However, the gain in HRQoL with SCS over the same period of time was markedly greater in the SCS group, with a mean EQ-5D score difference of 0.25 [p<0.001] and 0.21 [p<0.001], respectively at 3- and 6-months after adjusting for baseline variables. CONCLUSIONS: The addition of SCS to CMM in patients with neuropathic leg and back pain results in higher costs to health systems but also generates important improvements in patients' EQ-5D over the same period.

Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome.

Patients with neuropathic pain secondary to failed back surgery syndrome (FBSS) typically experience persistent pain, disability, and reduced quality of life. We hypothesised that spinal cord stimulation (SCS) is an effective therapy in addition to conventional medical management (CMM) in this patient population. We randomised 100 FBSS patients with predominant leg pain of neuropathic radicular origin to receive spinal cord stimulation plus conventional medical management (SCS group) or conventional medical management alone (CMM group) for at least 6 months. The primary outcome was the proportion of patients achieving 50% or more pain relief in the legs. Secondary outcomes were improvement in back and leg pain, health-related quality of life, functional capacity, use of pain medication and non-drug pain treatment, level of patient satisfaction, and incidence of complications and adverse effects. Crossover after the 6-months visit was permitted, and all patients were followed up to 1 year. In the intention-to-treat analysis at 6 months, 24 SCS patients (48%) and 4 CMM patients (9%) (p<0.001) achieved the primary outcome. Compared with the CMM group, the SCS group experienced improved leg and back pain relief, quality of life, and functional capacity, as well as greater treatment satisfaction (p

The infection risk of intrathecal drug infusion pumps after multiple refill procedures.

The objective of this study was to evaluate the long-term infection risk from refilling intrathecal drug delivery devices. We studied 25 patients (14 females and 11 males) with intrathecal infusion pumps placed for spasticity (23 patients) and chronic pain (two patients). In this study group there were 890 refill procedures (mean 35.6 ± 20.5; range 8-72 times) performed on an outpatient basis by four different physicians. All refill procedures were performed in a sterile and standardized fashion as suggested by the manufacturer, using manufacturer's approved kits for the refills. During the study period, five patients had recurrent infection of the urinary tract and three patients had recurrent infections of the respiratory tract. At the last pump refill of each patient, residual drug, extracted from the pump reservoir, was sent to a laboratory for aerobic and anaerobic cultures. All cultures, in all pumps, were negative for aerobic and anaerobic bacteria. We conclude that periodic refills of intrathecal implanted pumps do not seem to be a risk factor for infection if standard sterile refill procedures are performed. In this study, it was clear that comorbid infections from other parts of the body do not present as a risk for device contamination.

Spinal Cord Stimulation vs. Conventional Medical Management: A Prospective, Randomized, Controlled, Multicenter Study of Patients with Failed Back Surgery Syndrome (PROCESS Study).

Introduction. Since its first application in 1967, numerous case series indicate that spinal cord stimulation (SCS) is an effective treatment for the management of failed back surgery syndrome (FBSS). However, only one randomized controlled trial has demonstrated that SCS provides more effective pain relief than re-operation and conventional medical management. The PROCESS randomized, controlled, multicenter trial aims to assess the clinical effectiveness and cost-effectiveness of SCS when added to conventional medical management compared to conventional medical management alone in patients with FBSS. Methods/Design. A total of 100 FBSS patients with predominantly neuropathic leg pain will be recruited from 12 centers and randomized to receive either conventional medical management alone or in combination with SCS for a period of 24 months. Patients will be evaluated at 1, 3, 6, 9, 12, 18, and 24 months. At the 6-month visit, patients will be classified as successful (≥  50% pain relief in the legs) or unsuccessful (< 50% pain relief in the legs). If the results of the randomized treatment are unsuccessful, patients can cross over to the alternative treatment arm. Discussion. This paper highlights the rationale, design, methods, and challenges of an ongoing prospective, randomized, controlled, multicenter clinical trial that has been undertaken to obtain conclusive evidence of the clinical efficacy and cost-effectiveness of an SCS system in patients with FBSS.