[Quality of live of palliative outpatient care in Westphalia-Lippe focusing on contentedness of patients and their relatives - a multicenter cohort study]. / Qualität der ambulanten Palliativversorgung im Modell Westfalen-Lippe hinsichtlich der Zufriedenheit von Patienten und ihren Zugehörigen : Eine multizentrische Kohortenstudie.

BACKGROUND: In Westphalia-Lippe - unlike the rest of Germany - outpatient palliative care, as general and specialized palliative care (AAPV and SAPV), exists as part of an innovative care model. Ten years after its introduction, an evaluation is to be carried out, focusing on the treatment satisfaction of patients and their relatives as well as the extent to which the model has proved successful in urban versus rural care contexts. METHODS: In a multicenter cohort study, in 2019/20, from a total of 36 palliative care regions, 12 - 4 metropolitan, mixed and rural each - were randomly selected, with 20 palliative patients each. Using established instruments (MIDOS, HOPE), the patients were questioned about stressful symptoms and quality of life. Additionally, their relatives were asked about their satisfaction with the care provided. RESULTS: 227 patients were included. The care period was 82.3 days on average (median 47.5). Distressing symptoms were consistently well controlled with a slight tendency for symptoms to increase at the end of life (NRS < 4). There were no significant differences between urban and rural regions. The outpatient palliative care provided by doctors and nurses in Westphalia-Lippe was largely viewed positively by the relatives. CONCLUSIONS: In Westphalia-Lippe, patients in need of palliative care can be offered early and low- threshold structured outpatient palliative care, which is mainly provided by GPs and outpatient specialists. The role of the GP in primary medical care is being strengthened. In this interprofessional and interdisciplinary model, patient care is demand-oriented, that is, the intensity of care can switch between general (AAPV) and specialized care (SAPV) according to the disease progress. This model has proven itself in practice and provides good services benefits for palliative patients and their relatives.

Efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of moderate/severe chronic non-malignant pain: results of a prospectively designed pooled analysis of two randomised, double-blind clinical trials.

BACKGROUND: Two randomised 12-week, double-blind, parallel-group, multicenter studies comparing oxycodone PR/naloxone PR and oxycodone PR alone on symptoms of opioid-induced bowel dysfunction in patients with moderate/severe non-malignant pain have been conducted. METHODS: These studies were prospectively designed to be pooled and the primary outcome measure of the pooled data analysis was to demonstrate non-inferiority in 12-week analgesic efficacy of oxycodone PR/naloxone PR versus oxycodone PR alone. Patients with opioid-induced constipation were switched to oxycodone PR and then randomised to fixed doses of oxycodone PR/naloxone PR (n = 292) or oxycodone PR (n = 295) for 12 weeks (20-80 mg/day). RESULTS: No statistically significant differences in analgesic efficacy were observed for the two treatments (p = 0.3197; non-inferiority p < 0.0001; 95% CI -0.07, 0.23) and there was no statistically significant difference in frequency of analgesic rescue medication use. Improvements in Bowel Function Index score were observed for oxycodone PR/naloxone PR by Week 1 and at every subsequent time point (-15.1; p < 0.0001; 95% CI -17.3, -13.0). AE incidence was similar for both groups (61.0% and 57.3% of patients with oxycodone PR/naloxone PR and oxycodone PR alone, respectively). CONCLUSIONS: Results of this pooled analysis confirm that oxycodone PR/naloxone PR provides effective analgesia and suggest that oxycodone PR/naloxone PR improves bowel function without compromising analgesic efficacy. TRIAL REGISTRATION NUMBERS: ClinicalTrials.gov identifier: NCT00412100 and NCT00412152.

Efficacy, safety, and tolerability of fentanyl pectin nasal spray in patients with breakthrough cancer pain.

OBJECTIVE: Assessment of analgesic effectiveness, safety, and tolerability of fentanyl pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain (BTcP) in routine clinical practice. METHODS: A prospective, open-label, noninterventional study (4-week observation period, 3 month follow-up) of opioid-tolerant adults with BTcP in 41 pain and palliative care centers in Germany. Standardized BTcP questionnaires and patient diaries were used. Evaluation was made of patient-reported outcomes with respect to "time to first effect", "time to maximum effect", BTcP relief, as well as changes in BTcP-related impairment of daily life activities, quality-of-life restrictions, and health care resource utilization. RESULTS: A total of 235 patients were recruited of whom 220 completed all questionnaires and reported on 1,569 BTcP episodes. Patients reported a significant reduction of maximum BTcP intensity (11-stage numerical rating scale [0= no pain, 10= worst pain conceivable]) with FPNS (mean ± standard deviation = 2.8±2.3) compared with either that reported at baseline (8.5±1.5), experienced immediately before FPNS application (7.4±1.7), or that achieved with previous BTcP medication (6.0±2.0; P<0.001 for each comparison). In 12.3% of BTcP episodes, onset of pain relief occurred ≤2 minutes and in 48.4% ≤5 minutes; maximum effects were reported within 10 minutes for 37.9% and within 15 minutes for 79.4%. By the end of the study, there had been significant improvements versus baseline in BTcP-related daily life activities (28.3±16.9 vs 53.1±11.9), physical (35.9±8.4 vs 26.8±6.5), and mental quality of life (38.7±8.5 vs 29.9±7.9) (P<0.001 for each comparison vs baseline); in addition, health care resource utilization requirements directly related to BTcP were reduced by 67.5%. FPNS was well tolerated; seven patients (3.2%) experienced eight treatment-emergent adverse events of which none was serious. There were no indicators of misuse or abuse. CONCLUSION: FPNS provided rapid and highly effective BTcP relief in opioid-tolerant cancer patients with substantial improvements in daily functioning and quality of life. FPNS was well tolerated and associated with significant reductions in health care resource utilization and nursing assistance.