Tomás Gómez-Gascón

Oral versus intramuscular administration of vitamin B12 for the treatment of patients with vitamin B12 deficiency: a pragmatic, randomised, multicentre, non-inferiority clinical trial undertaken in the primary healthcare setting (Project OB12).

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.

Professional quality of life and organizational changes: a five-year observational study in Primary Care

BackgroundThe satisfaction and the quality of life perceived by professionals have implications for the performance of health organizations. We have assessed the variations in professional quality of life (PQL) and their explanatory factors during a services management decentralization process.MethodsIt was designed as a longitudinal analytical observational study in a Health Area in Madrid, Spain. Three surveys were sent out during an ongoing management decentralization process between 2001 and 2005. The professionals surveyed were divided into three groups: Group I (97.3% physicians), group II (92.5% nurses) and group III (auxiliary personnel). Analysis of the tendency and elaboration of an explanatory multivariate model was made. The PQL -35 questionnaire, based on Karaseks demand-control theory, was used to measure PQL. This questionnaire recognizes three PQL dimensions: management support (MS), workload (WL) and intrinsic motivation (IM).Results1444 responses were analyzed. PQL increased 0.16 (CI 95% 0.04 – 0.28) points in each survey. Group II presents over time a higher PQL score than group I of 0.38 (IC 95% 0.18 – 0.59) points. There is no difference between groups I and III.For each point that MS increases, PQL increases between 0.44 and 0.59 points. PQL decreases an average of between 0.35 and 0.49 point, for each point that WL increases.Age appears to have a marginal association with PQL (CI 95% 0.00 – 0.02), as it occurs with being single or not having a stable relationship (CI 95% 0.01 – 0.41). Performing management tasks currently or in the past is related to poorer PQL perception (CI 95% -0.45 – -0.06), and the same occurs with working other than morning shifts (CI 95% -0.03 – -0.40 points).PQL is not related to sex, location of the centre (rural/urban), time spent working in the organization or contractual situation.ConclusionWith the improvement in work control and avoiding increases in workloads, PQL perception can be maintained despite deep organizational changes at the macro-management level. Different professional groups experience different perceptions depending on how the changes impact their position in the organization.

LA CALIDAD DE VIDA RELACIONADA CON LA SALUD COMO FACTOR EXPLICATIVO DE LA UTILIZACIÓN DE LA CONSULTA DE MEDICINA DE FAMILIA: UN ESTUDIO BAJO EL MODELO CONDUCTUAL

Fundamento: La utilizacion de servicios sanitarios se ha estudiado desde varios modelos conceptuales. El objetivo de este trabajo es valorar la influencia de la calidad de vida relacionada con la salud (CVRS) en la variabilidad de la utilizacion de la consulta de atencion primaria bajo el «modelo conductual». Metodos: Estudio transversal analitico. Se entrevisto a 451 sujetos de 6 centros de salud en la Comunidad de Madrid. Se recogieron caracteristicas relacionadas con factores ambientales e individuales (predisponentes, facilitadores y de necesidad) y la CVRS (Euroqol-5D). La utilizacion se recogio de la historia clinica informatizada. Resultados: Hubo una mediana de 13 visitas/ano (rango intercuartil 7-20). La CVRS explicaba un 5,2% de la variabilidad en la utilizacion, vivir en barrios de rentas altas un 2,4%, la edad un 7,4%, la renta individual un 1,0% y los factores relacionados con «necesidad» (enfermedades cronicas e ingresos hospitalarios) explicaban un 4,1% de variabilidad adicional. Cada cambio de tercil de la CVRS se asocio con una disminucion del 13,8% en las consultas/ano. La residencia en zonas de renta alta y cada aumento de 1000€ de renta individual disminuian la utilizacion un 17,5% y un 9,5% respectivamente. La edad se asociaba con un aumento de un 8,0% de visitas/ano por decada. El sufrir enfermedades cronicas o ingresos hospitalarios suponia aumentar un 51,9% y un 26,5% las visitas anuales. Conclusiones: La CVRS se asocia de manera independiente con la variabilidad en la utilizacion de la consulta del medico de familia, una vez ajustado el efecto de la necesidad, como propone el «modelo conductual».

Economic valuation of health care services in public health systems: a study about Willingness to Pay (WTP) for nursing consultations.

Background Identifying the economic value assigned by users to a particular health service is of principal interest in planning the service. The aim of this study was to evaluate the perception of economic value of nursing consultation in primary care (PC) by its users. Methods and Results Economic study using contingent valuation methodology. A total of 662 users of nursing consultation from 23 health centers were included. Data on demographic and socioeconomic characteristics, health needs, pattern of usage, and satisfaction with provided service were compiled. The validity of the response was evaluated by an explanatory mixed-effects multilevel model in order to assess the factors associated with the response according to the welfare theory. Response reliability was also evaluated. Subjects included in the study indicated an average Willingness to Pay (WTP) of €14.4 (CI 95%: €13.2–15.5; median €10) and an average Willingness to Accept [Compensation] (WTA) of €20.9 (CI 95%: €19.6–22.2; median €20). Average area income, personal income, consultation duration, home visit, and education level correlated with greater WTP. Women and older subjects showed lower WTP. Fixed parameters explained 8.41% of the residual variability, and response clustering in different health centers explained 4–6% of the total variability. The influence of income on WTP was different in each center. The responses for WTP and WTA in a subgroup of subjects were consistent when reassessed after 2 weeks (intraclass correlation coefficients 0.952 and 0.893, respectively). Conclusions The economic value of nursing services provided within PC in a public health system is clearly perceived by its user. The perception of this value is influenced by socioeconomic and demographic characteristics of the subjects and their environment, and by the unique characteristics of the evaluated service. The method of contingent valuation is useful for making explicit this perception of value of health services.