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.

The presence of venous leg ulcers (VLU) is associated with emotional disorders in individuals who have conditions, such as depression, anxiety, and sleeping problems, which result in a reduced perceived quality of life by these individuals. The study aim was to describe the perceived quality of life and associated factors for individuals with VLU. We conducted a cross-sectional study in 22 primary care health centers with a sample of 93 individuals with VLU. The variables collected were the following: perceived quality of life measured with Spanish version of the Charing Cross Venous Ulcer Questionnaire (CCVUQ-e), ulcer severity measured with the RESVECH 2.0 Score, demographic variables, and those related to the healing process. The results showed a mean CCVUQ-e score of 47.4 ± 11.8 points (Mean ± SD), with the most affected dimension being the emotional status, followed by cosmesis, social interaction, and domestic activities. The mean RESVECH 2.0 score was 11.1 ± 3.7 points. An association was found between ulcer-related pain and poorer quality of life ( P < .05, t test) and between erythema in perilesional skin and poorer quality life ( P < .05, t test). The signs of infection and inflammation in the VLUs were as follows: increasing exudate, friable tissue, and biofilm-compatible tissue, which were associated with a poorer quality of life ( P < .05, t test). The multivariate model was statistically significant and explained a variability of 26% in the CCVUQ-e score. This study confirms that wound severity, pain, and signs of infection in VLU decrease the perceived quality of life of individuals with these wounds.

The management of patients with comorbidity and polypathology represents a challenge for all healthcare systems. Clinical practice guidelines (CPGs) have limitations when applied to this population. The aim of this study is to propose the terminology and methodology for optimally approach comorbidity and polypathology in the CPGs. Based on a literature review, we suggest a number of proposals for the approach in different phases of CPG preparation, with special attention to the inclusion of clusters of comorbidity in the initial questions the implementation of indirect evidence, the burden of disease management for patients and their environment, when establishing recommendations, as well as the strategies of dissemination and implementation. These proposals should be developed in greater depth with the implication of more agents in order to have valid and useful tools for this population.

BackgroundThe World Health Organization leads a global strategy to promote the initiation and maintenance of breast-feeding.Existing literature shows that education and supportive interventions, both for breast-feeding mothers as well as for healthcare professionals, can increase the proportion of women that use exclusive breast-feeding, however, more evidence is needed on the effectiveness of group interventions.MethodsThis study involves a community-based cluster randomised trial conducted at Primary Healthcare Centres in the Community of Madrid (Spain). The project aims to evaluate the effectiveness of an educational group intervention performed by primary healthcare professionals in increasing the proportion of mother-infant pairs using exclusive breastfeeding at six months compared to routine practice.The number of patients required will be 432 (216 in each arm). All mother-infant pairs using exclusive breastfeeding that seek care or information at healthcare centres will be included, as long as the infant is not older than four weeks, and the mother has used exclusive breastfeeding in the last 24 h and who gives consent to participate.The main response variable is mother-infant pairs using exclusive breast-feeding at six months.Main effectiveness will be analysed by comparing the proportion of mother-infant pairs using exclusive breast-feeding at six months between the intervention group and the control group. All statistical tests will be performed with intention-to-treat. The estimation will be adjusted using an explanatory logistic regression model. A survival analysis will be used to compare the two groups using the log-rank test to assess the effect of the intervention on the duration of breastfeeding. The control of potential confounding variables will be performed through the construction of Cox regression models.DiscussionWe must implement strategies with scientific evidence to improve the percentage of exclusive breast-feeding at six months in our environment as established by the WHO. Group education is an instrument used by professionals in Primary Care that favours the acquisition of skills and modification of already-acquired behaviour, all making it a potential method of choice to improve rates of exclusive breast-feeding in this period.Trial registrationThe trial was registered with ClinicalTrials.gov under code number NCT01869920 (Date of registration: June 3, 2013).