Using a decision-making and treatment checklist developed to facilitate the at-home palliative sedation process, we assessed the incidence and efficacy of palliative sedation for end-of-life cancer patients with intractable symptoms who died at home. We retrospectively reviewed the medical records of 370 patients who were followed by a palliative home care team. Twenty-nine of 245 patients (12%) who died at home had received palliative sedation. The mean age of the patients who received palliative sedation was 58 +/- 17 years, and the mean age of the patients who did not receive palliative sedation was 69 +/- 15 years (p = 0.002). No other differences were detected between patients who did or did not receive palliative sedation. The most common indications for palliative sedation were delirium (62%) and dyspnea (14%). Twenty-seven patients (93%) received midazolam for palliative sedation (final mean dose of 74 mg), and two (7%) received levomepromazine (final mean dose of 125 mg). The mean time between palliative sedation initiation and time of death was 2.6 days. In 13 of the cases (45%), the palliative sedation decision was made with the patient and his or her family members, and in another 13 patients (45%), the palliative sedation decision was made only with the patient's family members. We concluded that palliative sedation may be used safely and efficaciously to treat dying cancer patients with refractory symptoms at home.

BackgroundThe oral administration of vitamin B12 offers a potentially simpler and cheaper alternative to parenteral administration, but its effectiveness has not been definitively demonstrated. The following protocol was designed to compare the effectiveness of orally and intramuscularly administered vitamin B12 in the treatment of patients ≥65 years of age with vitamin B12 deficiency.Methods/designThe proposed study involves a controlled, randomised, multicentre, parallel, non-inferiority clinical trial lasting one year, involving 23 primary healthcare centres in the Madrid region (Spain), and patients ≥65 years of age. The minimum number of patients required for the study was calculated as 320 (160 in each arm). Bearing in mind an estimated 8-10% prevalence of vitamin B12 deficiency among the population of this age group, an initial sample of 3556 patients will need to be recruited.Eligible patients will be randomly assigned to one of the two treatment arms. In the intramuscular treatment arm, vitamin B12 will be administered as follows: 1 mg on alternate days in weeks 1 and 2, 1 mg/week in weeks 3–8,and 1 mg/month in weeks 9–52. In the oral arm, the vitamin will be administered as: 1 mg/day in weeks 1–8 and 1 mg/week in weeks 9–52. The main outcome variable to be monitored in both treatment arms is the normalisation of the serum vitamin B12 concentration at weeks 8, 26 and 52; the secondary outcome variables include the serum concentration of vitamin B12 (in pg/ml), adherence to treatment, quality of life (EuroQoL-5D questionnaire), patient 3satisfaction and patient preferences. All statistical tests will be performed with intention to treat and per protocol. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in analyses.DiscussionThe results of this study should help establish, taking quality of life into account, whether the oral administration of vitamin B12 is an effective alternative to its intramuscular administration. If this administration route is effective, it should provide a cheaper means of treating vitamin B12 deficiency while inducing fewer adverse effects. Having such an alternative would also allow patient preferences to be taken into consideration at the time of prescribing treatment.Trial registrationThis trial has been registered with ClinicalTrials.gov, number NCT 01476007, and under EUDRACT number 2010-024129-20.

Background and Aim: Consensus has been reached on the need to integrate palliative care in the follow-up examinations of chronic obstructive pulmonary disease (COPD) patients. We analyzed the survival from the initiation of follow-up by a palliative home care team (PHCT) and described the needs and end-of-life process. Setting and Design: This study was a prospective observational cohort study of advanced COPD patients referred to a PHCT. Sociodemographic variables, survival from the start date of follow-up using the Kaplan–Meier model, health resource consumption, perceived quality of life, main symptomatology, opioid use, and advanced care planning (ACP) were analyzed. Results: Sixty patients were included. The median survival was 8.3 months. Forty-two patients died at the end of the study (85% at home or in palliative care units). The most frequent cause of death was respiratory failure in 39 patients (93%), with 29 of these patients requiring sedation (69%). Dyspnea at rest, with an average of 5 (standard deviation [SD] 2) points, was the main symptom. Fifty-five patients (91%) required opioids for symptom control. The median score in the St. George's Respiratory Questionnaire was 72 (SD 13). The mean number of visits by the home team was 7 (SD 6.5). The mean number of admissions during the monitoring period was 1.5 (SD 0.15). Conclusions: The characteristics of the cohort appear suitable for a PHCT. The follow-up care provided by our multidisciplinary unit decreased the number of hospitalizations, favored the development of ACP, and enabled death at home or in palliative care units.

BackgroundPhysical activity may reverse frailty in the elderly, but we encounter barriers to the implementation of exercise programs in this population. Our main aim is to evaluate the effect of a multicomponent physical activity program, versus regular medical practice, on reverting pre-frailty status among the elderly, 12 months post-intervention.MethodsRandomized parallel group multicenter clinical trial located in primary care setting, among non-dependent and pre-frail patients > 70 years old, including 190 patients (95 intervention, 95 control group). Intervention: Multicomponent physical activity program (MEFAP, for its acronym in Spanish) with twelve 1.5 h-weekly sessions comprised of: 1. Informative session; 2. Exercises for improving aerobic resistance, muscle strength, propioception-balance and flexibility; and 3. Handing out of at-home exercise chart (twice/week). Main variable: pre-frailty according to the Fried phenotype. Secondary variables: sociodemographic, clinical and functional variables; exercise program adherence, patient satisfaction with the program and quality of life. We will perform an intention-to-treat analysis by comparing the retrogression from pre-frailty (1 or 2 Fried criteria) to robust status (0 Fried criteria) by the end of the intervention, 6 months and 12 months post-intervention. The accumulated incidence in each group will be calculated, as well as the relative risk (RR) and the number needed to treat (NNT) with their corresponding 95% confidence intervals. Protocol was approved by the Ethics Committee Hospital la Paz.DiscussionWithin the context of regular clinical practice, our results will provide evidence regarding the effects of exercise interventions on frailty among pre-frail older adults, a key population given their significant potential for functional, physical, and mental health improvement.Trial registrationNCT03568084. Registered 26 June 2018. Date of enrollment of the first participant to the trial: July 2nd 2018.