Differences in healthcare service utilization in patients with polypharmacy according to their risk level by adjusted morbidity groups: a population-based cross-sectional study.

BACKGROUND: Patients with polypharmacy suffer from complex medical conditions involving a large healthcare burden. This study aimed to describe the characteristics and utilization of primary care (PC) and hospital care (HC) and factors associated in chronic patients with polypharmacy, stratifying by adjusted morbidity groups (AMG) risk level, sex and age, and comparing with non-polypharmacy. METHODS: Cross-sectional study conducted in a Spanish basic healthcare area. Studied patients were those over 18 years with chronic diseases identified by the AMG tool from Madrid electronic clinical record, which was the data source. Sociodemographic, sociofunctional, clinical and healthcare utilization variables were described and compared by risk level, sex, age and having or not polypharmacy. Factors associated with healthcare utilization in polypharmacy patients were determined by a negative binomial regression model. RESULTS: In the area studied, 61.3% patients had chronic diseases, of which 16.9% had polypharmacy vs. 83.1% without polypharmacy. Patients with polypharmacy (vs. non-polypharmacy) mean age was 82.7 (vs. 52.7), 68.9% (vs. 60.7%) were women, and 22.0% (vs. 1.2%) high risk. Their average number of chronic diseases was 4.8 (vs. 2.2), and 95.6% (vs. 56.9%) had multimorbidity. Their mean number of annual healthcare contacts was 30.3 (vs. 10.5), 25.9 (vs. 8.8) with PC and 4.4 (vs. 1.7) with HC. Factors associated with a greater PC utilization in patients with polypharmacy were elevated complexity, high risk level and dysrhythmia. Variables associated with a higher HC utilization were also increased complexity and high risk, in addition to male sex, being in palliative care, having a primary caregiver, suffering from neoplasia (specifically lymphoma or leukaemia) and arthritis, whereas older age and immobilization were negatively associated. CONCLUSIONS: Polypharmacy population compared to non-polypharmacy was characterized by a more advanced age, predominance of women, high-risk, complexity, numerous comorbidities, dependency and remarkable healthcare utilization. These findings could help healthcare policy makers to optimize the distribution of resources and professionals within PC and HC systems, aiming for the improvement of polypharmacy management and rational use of medicines while reducing costs attributed to healthcare utilization by these patients.

Utilisation of primary healthcare services by Sjögren's syndrome patients in the Community of Madrid and associated factors: a population-based cross-sectional study.

OBJECTIVES: To describe the utilisation of primary health care (PHC) services and factors associated with its use by patients diagnosed with Sjögren's syndrome (SS). METHODS: Population-based cross-sectional cohort of SS patients in Madrid, Spain (SIERMA). Sociodemographic, diagnostic, clinical and PHC service utilisation variables were studied by bivariate analyses and regression models. RESULTS: A total of 4,778 SS patients were included, 65.2% classified as primary SS (pSS), while 34.8% associated with another autoimmune disease (associated SS). Mean age was 64.3 years, and 92.8% of the patients were women. A total of 87.5% used PHC services, with a mean of 19.8 consultations/year. The general practitioner was the most visited health professional, with a mean of 10.9 consultations/year, followed by the nurse, with a mean of 5.7. Characteristics associated with a greater use of PHC services in SS patients were associated SS, higher adjusted morbidity groups (AMG) risk level and older age. Additional factors included symptoms such as dry mouth, fatigue, dry vagina and joint and muscle pain; comorbidities such as atrial fibrillation, diabetes, hypertension, solid malignant neoplasms, coronary heart disease and chronic obstructive pulmonary disease; and treatments such as sterile saline solution, corticosteroids, opioids and biologic disease-modifying anti-rheumatic drugs. CONCLUSIONS: Most SS patients used PHC services during the study period, and the mean number of consultations was remarkably high. Utilisation was mainly associated with AMG risk level, ageing, glandular and extra-glandular symptoms, substantial comorbidities and various treatments. An optimised design of PHC policies will facilitate early diagnosis, improved management and better quality of life for SS patients.

Improvement in Quality of Life With the Use of a Technological System Among Patients With Chronic Disease Followed Up in Primary Care (TeNDER Project): Protocol for a Randomized Controlled Trial.

BACKGROUND: Among chronic diseases, cognitive, neurological, and cardiovascular impairments are becoming increasingly prevalent, generating a shift in health and social needs. Technology can create an ecosystem of care integrated with microtools based on biosensors for motion, location, voice, and expression detection that can help people with chronic diseases. A technological system capable of identifying symptoms, signs, or behavioral patterns could provide notification of the development of complications of disease. This would help the self-care of patients with chronic disease and save health care costs, promoting the autonomy and empowerment of patients and their caregivers, improving their quality of life (QoL), and providing health professionals with monitoring tools. OBJECTIVE: The main objective of this study is to evaluate the effectiveness of a technological system (the TeNDER system) to improve quality of life in patients with chronic diseases: Alzheimer disease, Parkinson disease, and cardiovascular disease. METHODS: A multicenter, randomized, parallel-group clinical trial will be conducted with a follow-up of 2 months. The scope of the study will be the primary care health centers of the Community of Madrid belonging to the Spanish public health system. The study population will be patients diagnosed with Parkinson disease, Alzheimer disease, and cardiovascular disease; their caregivers; and health professionals. The sample size will be 534 patients (380 in the intervention group). The intervention will consist of the use of the TeNDER system. The system will monitor the patients by means of biosensors, and their data will be integrated into the TeNDER app. With the information provided, the TeNDER system will generate health reports that can be consulted by patients, caregivers, and health professionals. Sociodemographic variables and technological affinity will be measured, as will views on the usability of and satisfaction with the TeNDER system. The dependent variable will be the mean difference in QoL score between the intervention and control groups at 2 months. To study the effectiveness of the TeNDER system in improving QoL in patients, an explanatory linear regression model will be constructed. All analyses will be performed with the 95% CI and robust estimators. RESULTS: Ethics approval for this project was received on September 11, 2019. The trial was registered on August 14, 2020. Recruitment commenced in April 2021, and the expected results will be available during 2023 or 2024. CONCLUSIONS: This clinical trial among patients with highly prevalent chronic illnesses and the people most involved in their care will provide a more realistic view of the situation experienced by people with long-term illness and their support networks. The TeNDER system is in continuous development based on a study of the needs of the target population and on feedback during its use from the users: patients, caregivers, and primary care health professionals. TRIAL REGISTRATION: ClinicalTrials.gov NCT05681065; https://clinicaltrials.gov/ct2/show/NCT05681065. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47331.

Design and Content Validation using Expert Opinions of an Instrument Assessing the Lifestyle of Adults: The 'PONTE A 100' Questionnaire.

Lifestyle, a major determinant of health status, comprises a number of habits and behaviours that form a part of daily life. People with healthy lifestyles have a better quality of life, suffer less disease, and have a longer life expectancy. This work reports the design and content validation of a questionnaire-the 'PONTE A 100' questionnaire-assessing the lifestyle of adults. This collects information across five dimensions-'Eating Habits', 'Physical Activity', 'Smoking and use of Alcohol and other Drugs', 'Emotional Wellbeing', and 'Safety and Non-intentional Injuries'-via the answering of a total 33 items. Psychometric validation of the instrument's content was obtained via expert opinions. This was performed by two rounds of assessment and involved 34 experts representing different health science disciplines (mean experience, 27.4 ± 9.4 years). At the end of each round, adjustments were made according to their recommendations. Agreement between the experts was examined using the Aiken V test. A final V value of 0.95 (95% CI, 0.90-1.00) was obtained for the questionnaire as a whole, highlighting the validity of its content. The questionnaire would therefore appear to be an appropriate instrument for assessing the lifestyle of adults.

Feasibility study of a clinical decision support system for polymedicated patients in primary care.

Age-related changes in pharmacokinetics and pharmacodynamics, multimorbidity, frailty, and cognitive impairment represent challenges for drug treatments. Moreover, older adults are commonly exposed to polypharmacy, leading to increased risk of drug interactions and related adverse events, and higher costs for the healthcare systems. Thus, the complex task of prescribing medications to older polymedicated patients encourages the use of Clinical Decision Support Systems (CDSS). This paper evaluates the CDSS miniQ for identifying potentially inappropriate prescribing in poly-medicated older adults and assesses the usability and acceptability of the system in health care professionals, patients, and caregivers. The results of the study demonstrate that the miniQ system was useful for Primary Care physicians in significantly improving prescription, thereby reducing potentially inappropriate medication prescriptions for elderly patients. Additionally, the system was found to be beneficial for patients and their caregivers in understanding their medications, as well as usable and acceptable among healthcare professionals, patients, and caregivers, highlighting the potential to improve the prescription process and reduce errors, and enhancing the quality of care for elderly patients with polypharmacy, reducing adverse drug events, and improving medication management.

[Prevalence of mental symptoms in the Sahrawi refugees in Tindouf camps, Algeria, determined using the Goldberg General Health Questionnaire 28]. / Prevalencia de síntomas mentales entre los refugiados saharauis en Tinduf, Argelia, utilizando el Cuestionario de Salud General Goldberg 28.

OBJECTIVE: To assess the prevalence of psychopathological symptoms among Saharawi refugees and the influence of sociodemographic factors on the phenotypic expression of mental disorders. DESIGN: Cross-sectional descriptive study. LOCATION: Primary and hospital health care. PARTICIPANTS: 383 participants over 18 years of age, 59.8% women and 40.2% men, with a mean age of 37.2 (SD = 13.0), from the Laayoune camp, and from the Rabuni National Hospital. METHODOLOGY: A descriptive, cross-sectional and analytical study was carried out between January and August 2017. Participants were selected by consecutive sampling. The main variable was the presence of mental symptoms, measured with the Goldberg General Health Questionnaire - 28. A descriptive analysis of each sociodemographic variable (age, sex, educational level, occupation) and its association with the main variable was carried out using Logistic regression. RESULTS: 43.3%, 95%CI (38.4-48.3) obtained a score that suggests the presence of mental symptoms. Women presented a mean score higher than men, in subscales A (somatic symptoms) and in subscale B (anxiety). Age over 50 years and having no educational level were associated with a higher probability of having mental symptoms. CONCLUSIONS: The study shows that the prevalence of mental symptoms among Saharawi refugees is high, and reinforces the need for more scientific research in the field of mental health to put the prevention of mental disorders and the promotion of mental health in the focus of health policy.

Prevalence and comorbidities of Sjogren's syndrome patients in the Community of Madrid: A population-based cross-sectional study.

OBJECTIVES: To estimate the prevalence, sociodemographic characteristics and comorbidities of Sjogren's syndrome (SS) patients in the Community of Madrid. METHODS: A population-based cross-sectional cohort of SS patients was derived from the information system for rare diseases in the Community of Madrid (SIERMA) and confirmed by a physician. The prevalence per 10,000 inhabitants among people aged ≥18years in June 2015 was calculated. Sociodemographic data and accompanying disorders were recorded. Univariate and bivariate analyses were performed. RESULTS: A total of 4,778 SS patients were confirmed in SIERMA; 92.8% were female, with a mean age of 64.3 (standard deviation=15.4) years. A total of 3,116 (65.2%) patients were classified as primary SS (pSS), and 1,662 (34.8%) as secondary SS (sSS). The prevalence of SS among people aged ≥18 years was 8.4/10,000 (95%Confidence interval [CI]=8.2-8.7). The prevalence of pSS was 5.5/10,000 (95%CI=5.3-5.7), and that of sSS was 2.8/10,000 (95%CI=2.7-2.9), with rheumatoid arthritis (20.3%) and systemic lupus erythematosus (8.5%) being the most prevalent associated autoimmune diseases. The most common comorbidities were hypertension (40.8%), lipid disorders (32.7%), osteoarthritis (27.7%) and depression (21.1%). The most prescribed medications were nonsteroidal anti-inflammatory drugs (31.9%), topical ophthalmic therapies (31.2%) and corticosteroids (28.0%). CONCLUSION: The prevalence of SS in the Community of Madrid was similar to the overall prevalence worldwide observed in previous studies. SS was more frequent in women in their sixth decade. Two out of every three SS cases were pSS, while one-third were associated predominantly with rheumatoid arthritis and systemic lupus erythematosus.

Household food insecurity and its association with overweight and obesity in children aged 2 to 14 years.

BACKGROUND: The objective was to estimate the prevalence of household food insecurity (HFI) depending on sociodemographic factors and its association with lifestyle habits and childhood overweight and obesity. METHODS: Data was collected from 1,938 children aged 2 to 14 years who participated in the "Study about Malnutrition" of the Community of Madrid. Weight and height were obtained through physical examination. Body mass index was calculated as weight/height2 (kg/m2) and the criteria of the WHO were used for determining conditions of overweight and obesity. The participants' parents answered a structured questionnaire about their diet, lifestyle (physical activity and screen time), and food insecurity. The diet quality was assessed with the Healthy Eating Index in Spain and food insecurity, defined as the lack of consistent access to sufficient food for a healthy life, was measured via three screening questions and the Household Food Insecurity Access Scale (HFIAS). Odds Ratios (ORs) and Relative Risk Ratios (RRRs) were estimated using logistic regression models and adjusted for confounding variables. RESULTS: The overall prevalence of HFI was 7.7% (95% CI: 6.6‒9.0), with lower values in children 2 to 4 years old (5.7%, 95% CI: 4.0‒8.1) and significantly higher values in households with low family purchasing power [37.3%; OR: 8.99 (95% CI: 5.5‒14.6)]. A higher prevalence of overweight (33.1%) and obesity (28.4%) was observed in children from families with HFI, who presented a lower quality diet and longer screen time compared to those from food-secure households (21.0% and 11.5%, respectively). The RRR of children in families with HFI relative to those from food-secure households was 2.41 (95% CI: 1.5‒4.0) for overweight and 1.99 (95% CI: 1.2‒3.4) for obesity. CONCLUSION: The prevalence of HFI was high in the paediatric population, especially in households with low family purchasing power. HFI was associated with lower diet quality and higher prevalence of childhood overweight and obesity. Our results suggest the need for paediatric services to detect at-risk households at an early stage to avoid this dual burden of child malnutrition.

Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12).

OBJECTIVES: To compare the effectiveness of oral versus intramuscular (IM) vitamin B12 (VB12) in patients aged ≥65 years with VB12 deficiency. DESIGN: Pragmatic, randomised, non-inferiority, multicentre trial in 22 primary healthcare centres in Madrid (Spain). PARTICIPANTS: 283 patients ≥65 years with VB12 deficiency were randomly assigned to oral (n=140) or IM (n=143) treatment arm. INTERVENTIONS: The IM arm received 1 mg VB12 on alternate days in weeks 1-2, 1 mg/week in weeks 3-8 and 1 mg/month in weeks 9-52. The oral arm received 1 mg/day in weeks 1-8 and 1 mg/week in weeks 9-52. MAIN OUTCOMES: Serum VB12 concentration normalisation (≥211 pg/mL) at 8, 26 and 52 weeks. Non-inferiority would be declared if the difference between arms is 10% or less. Secondary outcomes included symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction. RESULTS: The follow-up period (52 weeks) was completed by 229 patients (80.9%). At week 8, the percentage of patients in each arm who achieved normal B12 levels was well above 90%; the differences in this percentage between the oral and IM arm were -0.7% (133 out of 135 vs 129 out of 130; 95% CI: -3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: -1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis. At week 52, the percentage of patients who achieved normal B12 levels was 73.6% in the oral arm and 80.4% in the IM arm; these differences were -6.3% (103 out of 112 vs 115 out of 117; 95% CI: -11.9 to -0.1; p=0.025) and -6.8% (103 out of 140 vs 115 out of 143; 95% CI: -16.6 to 2.9; p=0.171), respectively. Factors affecting the success rate at week 52 were age, OR=0.95 (95% CI: 0.91 to 0.99) and having reached VB12 levels ≥281 pg/mL at week 8, OR=8.1 (95% CI: 2.4 to 27.3). Under a Bayesian framework, non-inferiority probabilities (Δ>-10%) at week 52 were 0.036 (PPT) and 0.060 (ITT). Quality of life and adverse effects were comparable across groups. 83.4% of patients preferred the oral route. CONCLUSIONS: Oral administration was no less effective than IM administration at 8 weeks. Although differences were found between administration routes at week 52, the probability that the differences were below the non-inferiority threshold was very low. TRIAL REGISTRATION NUMBERS: NCT01476007; EUDRACT (2010-024129-20).

Risk-Taking Attitudes of Patients who Seek Health Care: An Exploratory Approach through Lottery Games. / La valoración de la actitud ante el riesgo en personas que demandan cuidados en salud: una aproximación mediante juegos de loterías utilizando generalized estimating equations.

BACKGROUND: The characterization of the risk-taking attitude of individuals may be useful for planning health care interventions. It has been attempted to study expressions of risk-taking attitude and evaluate characteristics of a standard lottery game in a population that seeks health care to elicit these attitudes. METHODS: Multicentric cross-sectional study. Demographic and socioeconomic characteristics, quality of life (EuroQol-5D), and health risk behaviors were collected from 662 users of 23 health centers selected by random sampling. Risk-taking attitude was evaluated by means of a self-evaluation scale and two lottery games, (L1 and L2; L2 included the possibility of economic losses). Generalized estimating equations (GEE) explicative models were used to evaluate the variability of risk-taking attitude. RESULTS: Nineteen percent out of interviewed people (CI95%: 15.6-22.6%) expressed a high risk appetite, but only 10.0% (CI95% 7.0 to 13.0) were classified as risk-seeking by L2. It was found association between increased risk appetite and having a better perception of health status (0.110, CI95%: 0,007-0,212) or a higher income (0.010, CI95%: 0.017- 0.123) or smoking status (0.059, CI95%: 0.004- 0.114). Being Spanish was associated with lower risk appetite (-0.105, CI95%: -0.005 --0.205), as being over 65 (-0.031, CI95%:- 0.061- -0.001) or a woman (-0.038, CI95%:-0.064- -0.012). The intraclass correlation coefficient for self-evaluation scale was 0.511 (95% CI: 0.372 to 0.629), 0.571 (95% CI: 0.441 to 0.678) for L1 and 0.349 (95% CI: 0.186-0.493) to L2. CONCLUSIONS: People who seek health care express certain inclination to risk, but this feature is attenuated when methodologies involving losses are used. Risk appetite seems greater in young people, males, people with better health, or more income, and in immigrants. Lottery games such as the proposed ones are a simple and useful tool to estimate individuals' inclination to risk.

OBJETIVO: La caracterización de la actitud ante el riesgo puede ser útil en la planificación de las intervenciones sanitarias. El objetivo fue estudiar la actitud ante el riesgo de una población que demanda cuidados de salud y evaluar la capacidad de un juego de loterías para evidenciar dicha actitud. METODOS: Estudio multicéntrico transversal. Se recogieron características demográficas, socioeconómicas, de calidad de vida y conductas de riesgo en salud de 662 personas usuarias de 23 centros de salud seleccionadas mediante muestreo aleatorio. La actitud ante el riesgo se evaluó mediante una escala subjetiva y mediante dos juegos de azar (L1 y L2; L2 incluía la posibilidad de pérdidas económicas). Se realizaron modelos explicativos para valorar la variabilidad de la propensión al riesgo utilizando Generalized Estimating Equations (GEE). RESULTADOS: El 19,1% (IC95%:15,6-22,6%) de los sujetos expresaron una propensión al riesgo alta, el 10,0% (IC95%:7,0-13,0) fueron clasificados como propensos al riesgo con L2. Se encontró asociación entre una mayor propensión al riesgo y tener mejor percepción del estado de salud (0,110; IC95%:0,007- 0,212) o mayor renta (0,010; IC95%: 0,017- 0,123) o ser fumador (0,059; IC95%: 0,004-0,114). Ser español se relacionaba con menor propensión al riesgo (-0,105; IC95%: -0,205- -0,005), al igual que ser mayor de 65 años (-0,031; IC95%:-0,061- -0,001) o ser mujer (-0,038, IC95%:-0,064- -0,012). El coeficiente de correlación intraclase para la escala subjetiva fue 0,511 (IC95%:0,372-0,629), 0,571 (IC95%:0,441-0,678) para L1 y 0,349 (IC95%:0,186-0,493) para L2. CONCLUSIONES: Las personas que demandan cuidados de salud presentan con frecuencia propensión al riesgo, la cual se atenúa cuando se caracteriza mediante metodologías que implican pérdidas. La propensión al riesgo parece mayor en personas jóvenes, varones, con mejor estado de salud, con mayor renta y en inmigrantes.

Effectiveness of an intervention for prevention and treatment of burnout in primary health care professionals.

BACKGROUND: Burnout syndrome is an important health problem that affects many professionals and must be addressed globally, with both organizational measures and personal interventions. Burnout of health professionals can be prevented in order to avoid personal, familial, and social consequences, as well as repercussions for patients. METHODS/DESIGN: This work describes a protocol for a controlled, pragmatic, randomized clinical trial in 2 parallel groups: intervention and control. All health professionals from 7 health care centers will form the intervention group, and all health professionals from 7 different health care centers will form the control group. The intervention group will receive 16 hours of training at their work place. The Maslach's burnout inventory, the Cuestionario de Desgaste Profesional Médico or the Cuestionario de Desgaste Profesional de Enfermería, and the 28-item Goldberg's General Health Questionnaire, validated for our setting, will be used as measurement tools. Change in the average scores from the Maslach's burnout inventory emotional exhaustion scale will be compared between the intervention and control groups, measured as intention-to-treat, and the intervention will be considered effective if a minimum decrease of 20% is achieved. DISCUSSION: Due to the deleterious consequences of burnout syndrome for people suffering from it and for the organization where they work, it is necessary to evaluate the effectiveness of certain interventions for its prevention. Organizational measures are important for preventing burnout syndrome, but so is providing professionals with coping strategies, as this group intervention intends to do. TRIAL REGISTRATION: ClinicalTrials.gov processed this record on June 10, 2013. ClinicalTrials.gov Identifier: NCT01870154.

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.

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).

BACKGROUND: The 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/DESIGN: The 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. DISCUSSION: The 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 REGISTRATION: This trial has been registered with ClinicalTrials.gov, number NCT 01476007, and under EUDRACT number 2010-024129-20.

A study of the user's perception of economic value in nursing visits to primary care by the method of contingent valuation.

BACKGROUND: The identification of the attribution of economic value that users of a health system assign to a health service could be useful in planning these services. The method of contingent valuation can provide information about the user's perception of value in monetary terms, and therefore comparable between services of a very different nature. This study attempts to extract the economic value that the subject, user of primary care nursing services in a public health system, attributes to this service by the method of contingent valuation, based on the perspectives of Willingness to Pay (WTP) and Willingness to Accept [Compensation] (WTA). METHODS/DESIGN: This is an economic study with a transversal design. The contingent valuation method will be used to estimate the user's willingness to pay (WTP) for the care received from the primary care nurse and the willingness to accept [compensation] (WTA), were this service eliminated. A survey that meets the requisites of the contingent valuation method will be constructed and pilot-tested. Subsequently, 600 interviews will be performed with subjects chosen by systematic randomized sampling from among those who visit nursing at twenty health centers with different socioeconomic characteristics in the Community of Madrid. The characteristics of the subject and of the care received that can explain the variations in WTP, WTA and in the WTP/WTA ratio expressed will be studied. A theoretical validation of contingent valuation will be performed constructing two explanatory multivariate mixed models in which the dependent variable will be WTP, and the WTP/WTA relationship, respectively. DISCUSSION: The identification of the attribution of economic value to a health service that does not have a direct price at the time of use, such as a visit to primary care nursing, and the definition of a profile of "loss aversion" in reference to the service evaluated, can be relevant elements in planning, enabling incorporating patient preferences to health policy decision-making.

[Quality of life related to health as a factor explaining the use of family medical consultation: a study on the behavioral model]. / 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.

BACKGROUND: Health services utilization has been studied under several conceptual models. This study is aimed to assess the influence of Health Related Quality of Life (HRQL) on the variability of the primary care consultation utilization under the <> METHODS: A cross-sectional study. Interviews were conducted with 451 subjects at six health centers in the Community of Madrid. Environmental and individual characteristics (predisposing, enabling and need factors) and HRQL (EuroQol-5D) were collected. Annual visits were retrieved from the computerized clinical history. RESULTS: Median utilization was 13 visits/year (interquartile range 7-20). HRQL explained 5,2% of utilization variability, living in high-income areas an additional 2.4%, age a 7.4%, incomes a 1.0% and <> (chronic illnesses or a hospital admission in the last year) explained an additional 4.1% of the variability. Each increase of the tercile in the perception of HRQL was associated with a decrease of 13,8% of the number of visits/year. Living in high-income areas, and each increase of 1000 in the incomes decreased the percentage of annual visits 17.5 % and 9.5% respectively. Age is associated with an increase of 8.0% of annual visits per decade. Suffering from chronic illnesses or a hospital admission in the last year increased the average number of visits/year to 51.9 and 26.5%. CONCLUSIONS: HRQL is independently associated with the variability of the demand for the family physician after adjusting by << health need>> factors as the <> proposes.

Differences between willingness to pay and willingness to accept for visits by a family physician: a contingent valuation study.

BACKGROUND: The economic value attributed by users of health services in public health systems can be useful in planning and evaluation. This value can differ from the perspectives of Willingness to Pay (WTP) and Willingness to Accept [Compensation] (WTA).Our objective was to study the perceptions of the patient about the service provided by the family physician by means of the WTA/WTP ratio. METHODS: An economic evaluation study by the Contingent Valuation Method was designed. Interviews were conducted with 451 subjects at six health centres (four urban and two rural) in areas with different socioeconomic characteristics. A payment card was used to measure the WTP and WTA. Other characteristics of the subject or service that could influence these responses were collected. An explicative model was constructed to study the WTA/WTP relationship. RESULTS: Four hundred and four subjects (89.6%) expressed a WTP and WTA different from zero. The WTA/WTP quotient showed a median of 1.55 (interquartile range 1-3.08) and a mean of 3.30 (IC 95%: 2.84-3.75). The WTA/WTP ratio increases with age and in low-income areas. It decreases in professional groups with more specialized activities, with growing family income, and in the chronically ill. Other characteristics related to the perception of state of health, accessibility to the service, satisfaction, or perception of risk were not explicative. CONCLUSIONS: Subjects who were older and had a less favourable socioeconomic situation expressed a higher WTA/WTP ratio when valuing the visit to the family physician. These characteristics could identify a profile of "aversion to loss" with respect to this service.

[Patient satisfaction with the patient-doctor relationship measured using the questionnaire (PDRQ-9)]. / Satisfacción del paciente con la relación con su médico de familia: un estudio con el Patient-Doctor Relationship Questionnaire.

OBJECTIVE: To describe patient satisfaction of their relationship with the family physician, using the PDRQ-9 questionnaire and assess its psychometric properties. DESIGN: Cross-sectional study. SETTING: Six Primary Care Health centres in the Community of Madrid, Spain. PARTICIPANTS: Four hundred and fifty one patients randomly selected from those who had just visited their family physician. INTERVENTIONS: Interviews were carried out to collect demographic characteristics, health needs, the accessibility to the service, and the socioeconomic situation of the subjects. MEASUREMENTS: The PDRQ-9 responses were collected and a synthetic satisfaction index was constructed. A multivariable model was designed to explain differences in satisfaction. RESULTS: The mean satisfaction index was 4.41 (95% CI: 4.33-4.48) on a scale of 1 (the worst) to 5 (the best satisfaction possible), with a median of 4.78 (interquartile range 4.00-5.00). Four of every 10 subjects expressed the maximum possible satisfaction ("ceiling effect"). A single factor explained 75.3% of the variance, with a Cronbach alpha value of 0.952. Age (OR 1.03, 95% CI: 1.02-1.05) and living in rural areas (OR 1.44, 95% CI: 0.94-2.20) were associated with above average satisfaction. CONCLUSIONS: Primary care users feel their relationship with their family physicians are very satisfactory, particularly in those who are older and who live in rural areas. The PDRQ-9 questionnaire shows a high internal consistency, but it is not good enough to discriminate in the upper part of the scale.

Perception of the economic value of primary care services: a Willingness to Pay study.

OBJECTIVE: Identify the economic value the user attributes to the visit to the family physician, in a setting of a National Health System, by the Willingness to Pay (WTP) expressed. METHODS: Economic evaluation study, by the contingent valuation method. Questions were asked about WTP using a payment card format. Interviews were conducted with 451 subjects, in areas with different socioeconomic characteristics. An ordered probit was used to evaluate model's validity. RESULTS: Median WTP expressed was euro18 (interquartile range euro8-28), not including "zero-answers" of thirty-four subjects (7.5%). This value represents 2% of average adjusted family incomes. Patients with higher incomes or with chronic illnesses presented a probability of 5-14 percentage points of expressing a high WTP. For every point of increase of patient satisfaction, the probability of presenting a WTP in the lowest range decreases 7.0 percentage points. Subjects with a low education level and those older than 65 expressed a lower WTP. Accessibility, risk perception, nationality and having private insurance were not related to the WTP expressed. CONCLUSIONS: Users of primary care have a clear perception of the economic value of care received from the family physician, even in a framework of providing services financed by taxes and without cost at the moment of use. This value increases in subjects with higher incomes, with greater need for care, or more satisfied.

[Measurement of the evaluative capacity of the CVP-35 questionnaire for perceiving the quality of professional life]. / Medición de la capacidad evaluadora del cuestionario CVP-35 para la percepción de la calidad de vida profesional.

OBJECTIVE: To establish the CVP-35 evaluative properties to measure the professional quality of life (PQL). DESIGN: Prospective, observational study. SETTING: A primary care area in the Community of Madrid, Spain. PARTICIPANTS: A total of 149 sanitary workers with some burnout sign measured by Maslach Burnout Inventory (MBI) participated. MEASUREMENTS: They fulfilled MBI, Goldberg Health Questionnaire (GHQ-28), and CVP-35 questionnaires at the beginning and after a year of follow-up, in which 73 subjects took part in activities for coping stress. It was assessed the change of PQL and their domains managerial support (PQL-MS), work load (PQL-WL), intrinsic motivation (PQL-IM) for the subjects with variations at the MBI, or GHQ-28 punctuation greater than 0.5 SD of the initial distribution. RESULTS: Variations in CVP-35 and their domains correlate weakly with changes in MBI and GHQ-28 (r<0.500), but they are congruent with the conceptual model. In the individuals with significant variations in the GHQ-28, they appreciate an average change in PQL and their domains between 0.18 and 0.55 points (absolute value). In those with significant variations in the MBI domains, PQL presented average absolute variations between 0.23 and 0.45 points, PQL-MS between 0.30 and 0.67, PQL-WL between 0.01 and 0.55 and PQL-IM between 0.22 and 0.83 points. CONCLUSIONS: CVP-35 is a sensitive-to-change instrument under population point of view. Changes in PQL perception or in any of their domains of 0.5 points could be pointed as relevant.

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

BACKGROUND: The 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. METHODS: It 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 Karasek's demand-control theory, was used to measure PQL. This questionnaire recognizes three PQL dimensions: management support (MS), workload (WL) and intrinsic motivation (IM). RESULTS: 1444 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. CONCLUSION: With 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.