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1.
Int J Nurs Stud ; 120: 103955, 2021 Aug.
Article in English | MEDLINE | ID: mdl-34051585

ABSTRACT

BACKGROUND: Caregivers of patients with chronic conditions or disability experience fatigue, burden and poor health-related quality of life. There is evidence of the effectiveness of support interventions for decreasing this impact. However, little is known about the benefits of home-based nursing intervention in primary health care. OBJECTIVES: To evaluate the effectiveness of a home-based, nurse-led-intervention (CuidaCare) on the quality of life of caregivers of individuals with disabilities or chronic conditions living in the community, measured at 12-month follow-up. METHODS: A pragmatic, two-arm, cluster-randomized controlled trial with a 1-year follow-up period was performed between June 2013 and December 2015. Consecutive caregivers aged 65 years or older, all of whom assumed the primary responsibility of caring for people with disabling conditions for at least 6 months a year, were recruited from 22 primary health care centers. Subsequently, 11 centers were randomly assigned to usual care group, and 11 were assigned to the intervention group. The caregivers in the intervention group received the usual care and additional support (cognitive restructuring, health education and emotional support). The primary outcome was quality of life, assessed with the EQ-5D instrument (visual analog scale and utility index score); the secondary outcome variables were perception of burden, anxiety, and depression. Data were collected at baseline, at the end of the intervention, and at the 6- and 12-month follow-up visits. We analyzed the primary outcome as intention-to-treat, and missing data were added using the conditional mean single imputation method. RESULTS: A total of 224 caregivers were included in the study (102 in the intervention group and 122 in the usual care group). Generalized Estimating Equation models showed that the CuidaCare intervention was associated with a 5.46 point (95% CI: 2.57; 8.35) change in the quality of life, as measured with the visual analog scale adjusted for the rest of the variables at 12 months. It also produced an increase of 0.04 point (95% CI: 0.01; 0.07) in the utilities. No statistically significant differences were found between the two groups at 12 months with respect to the secondary outcomes. CONCLUSIONS: The findings suggest that incorporating a home-based, nurse-led-intervention for caregivers into primary care can improve the health-related quality of life of caregivers of patients with chronic or disabling conditions.


Subject(s)
Caregivers , Quality of Life , Cognition , Cost-Benefit Analysis , Humans , Primary Health Care
2.
BMJ Open ; 10(8): e033687, 2020 08 20.
Article in English | MEDLINE | ID: mdl-32819927

ABSTRACT

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).


Subject(s)
Vitamin B 12 Deficiency , Vitamin B 12 , Administration, Oral , Aged , Bayes Theorem , Humans , Primary Health Care , Quality of Life , Spain , Vitamin B 12/therapeutic use , Vitamin B 12 Deficiency/drug therapy
3.
Acta Diabetol ; 57(9): 1065-1072, 2020 Sep.
Article in English | MEDLINE | ID: mdl-32253608

ABSTRACT

AIMS: Inequalities in diabetes prevalence among immigrants from Andean countries remain unknown. Andean populations are one of the largest groups of immigrants in Madrid city. We examined the association between country of birth and type 2 diabetes mellitus (T2DM) prevalence in Andean immigrant population relative to Spanish-natives; and whether this association varied by age, sex and length of residence. METHODS: We analyzed 1,258,931 electronic medical records from Spanish native and Andean immigrant adults aged 40-75 years of Madrid city. We used logistic regression and test interaction terms to address our aims. RESULTS: Andean immigrants showed 1.13 (95% CI 1.10-1.17) greater adjusted odds for T2DM than Spanish natives. This association was positive in Ecuadorians and Bolivians but protective in Peruvians and Colombians. There was heterogeneity of this association according to age and sex. Relative to Spanish natives, odds of T2DM in Andeans of all ages and women were higher but lower in men. CONCLUSION: Andean adults showed greater odds of T2DM compared with Spanish native adults in Madrid, with variation observed by age and sex. These findings emphasize the need for studying immigrant populations in a disaggregated manner to implement specific clinical and preventive approaches.


Subject(s)
Diabetes Mellitus, Type 2/epidemiology , Emigrants and Immigrants/statistics & numerical data , Hispanic or Latino/statistics & numerical data , Adult , Aged , Cities/epidemiology , Cities/ethnology , Diabetes Mellitus, Type 2/ethnology , Europe/epidemiology , Female , Humans , Male , Middle Aged , Prevalence , Socioeconomic Factors , Spain/epidemiology
4.
PLoS One ; 15(1): e0226398, 2020.
Article in English | MEDLINE | ID: mdl-31971952

ABSTRACT

PURPOSE: Uncertainty exists regarding the best way to communicate cardiovascular risk (CVR) to patients, and it is unclear whether the comprehension and perception of CVR varies according to the format used. The aim of the present work was to determine whether a strategy designed for communicating CVR information to patients with poorly controlled high blood pressure (HBP), but with no background of cardiovascular disease, was more effective than usual care in the control of blood pressure (BP) over the course of a year. METHODS: A pragmatic, two-arm, cluster-randomized controlled trial was performed. Consecutive patients aged 40-65 years, all diagnosed with HBP in the last 12 months, and all of whom showed poor control of their condition (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg), were recruited at 22 primary healthcare centres. Eleven centres were randomly assigned to the usual care arm, and 11 to the informative intervention arm (Educore arm). At the start of the study, the Educore arm subjects were shown the "low risk SCORE table", along with impacting images and information pamphlets encouraging the maintenance of good cardiovascular health. The main outcome variable measured was the control of HBP; the secondary outcome variables were SCORE table score, total plasma cholesterol concentration, use of tobacco, adherence to prescribed treatment, and quality of life. RESULTS: The study participants were 411 patients (185 in the Educore arm and 226 in the usual care arm). Multilevel logistic regression showed that, at 12 months, the Educore intervention achieved better control of HBP (OR = 1.57; 1.02 to 2.41). No statistically significant differences were seen between the two arms at 12 months with respect to the secondary outcomes. CONCLUSIONS: Compared to usual care, the Educore intervention was associated with better control of HBP after adjusting for age, baseline SBP and plasma cholesterol, at 12 months.


Subject(s)
Antihypertensive Agents/therapeutic use , Cardiovascular Diseases/etiology , Early Intervention, Educational , Hypertension/complications , Medication Adherence/statistics & numerical data , Patient Education as Topic , Primary Health Care/standards , Adult , Aged , Blood Pressure , Cardiovascular Diseases/prevention & control , Female , Humans , Hypertension/drug therapy , Male , Middle Aged
5.
Gac. sanit. (Barc., Ed. impr.) ; 33(2): 112-118, mar.-abr. 2019. tab, graf
Article in Spanish | IBECS | ID: ibc-183672

ABSTRACT

Objetivos: Los objetivos de este estudio son describir la frecuencia de exposición y la actitud de los médicos internos residentes (MIR) de la Comunidad de Madrid (CM) con la industria farmacéutica (IF), y analizar la asociación con la especialidad, el entorno profesional y la formación recibida. Métodos: Estudio descriptivo mediante encuesta electrónica durante mayo y junio de 2015 a los MIR de la CM. Se recogieron variables sociodemográficas y de relación con la IF en cuatro bloques: frecuencia de interacción, actitudes y percepciones, entorno y marco regulatorio, y habilidades adquiridas; con los dos primeros se elaboró un índice sintético de relación con la IF (ISIF). Análisis bivariado y multivariado de regresión logística. Resultados: Respondieron 350 residentes (28% de medicina familiar y comunitaria [MFyC]), 57% de especialidades hospitalarias y 15% de otras). El 98% refirió haber tenido relación con la IF. El 20% creía que influye en su prescripción y el 48% en los demás médicos. El 96% no había recibido información de su colegio profesional, el 80% desconocía si había normas en su sociedad científica y el 50% no sabía si las había en su institución. El 65% consideró necesaria más formación. Los residentes de especialidades hospitalarias presentaron más probabilidad de presentar un ISIF igual o superior al percentil 75 que los de MFyC (odds ratio [OR]: 3,96; intervalo de confianza del 95% [IC95%]: 1,88-8,35). Formarse en entornos informales se asoció a un ISIF menor o igual al percentil 25 (OR: 2,83; IC95%: 1,32-6,07). Conclusiones: Los MIR de la CM tienen un alto nivel de contacto con la IF y creen que su influencia es limitada. Los residentes de especialidades hospitalarias presentan mayor contacto. Las regulaciones son poco conocidas por los residentes, que consideran que es necesaria más formación


Objective: To assess the frequency of exposure and attitudes to the pharmaceutical industry (PI) of residents in the Region of Madrid (RM), Spain, and to analyse the association with specialty, professional environment and training. Methods: Cross-sectional electronic survey in May and June 2015 of all medical residents in RM. We collected sociodemographic variables and those of interaction with the PI in four blocks: frequency of interactions, attitudes and perceptions, environment and regulatory framework, and skills; with the first two blocks we created a Synthetic PI Interaction Index (SPIII). Bivariate and multivariate analysis of logistic regression. Results: 350 resident's responses (28% family and community medicine [FCM], 57% hospital, 15% others). Ninety-eight percent reported interacting with the PI. Twenty percent believed their prescribing was influenced by the PI and 48% believed it was influenced by other doctors. Sixty-five precent considered more training necessary. Ninety-six percent had received no information from their college of physicians, 80% did not know the regulations in their medical society and 50% were unaware of those of their institution. Hospital specialty residents showed more likelihood of SPIII ≥ percentile 75 than those of FCM (odds ratio [OR]: 3.96; 95% confidence interval [95%CI]: 1.88-8.35). Training in informal settings was associated with SPIII ≤ percentile 25 (OR: 2.83; 95%CI: 1.32-6.07). Conclusions: The medical residents in RM had a high level of interaction with the PI and believed its influence low. Hospital specialty residents showed more interaction with the PI. Regulations were not well known by residents and they consideredmore training necessary


Subject(s)
Humans , Male , Female , Young Adult , Adult , Drug Industry/trends , Technology, Pharmaceutical/education , Internship and Residency/trends , Drug Prescriptions/classification , Ethics, Pharmacy , Conflict of Interest , Interinstitutional Relations , Bioethical Issues
6.
Gac Sanit ; 33(2): 112-118, 2019.
Article in Spanish | MEDLINE | ID: mdl-28993045

ABSTRACT

OBJECTIVE: To assess the frequency of exposure and attitudes to the pharmaceutical industry (PI) of residents in the Region of Madrid (RM), Spain, and to analyse the association with specialty, professional environment and training. METHODS: Cross-sectional electronic survey in May and June 2015 of all medical residents in RM. We collected sociodemographic variables and those of interaction with the PI in four blocks: frequency of interactions, attitudes and perceptions, environment and regulatory framework, and skills; with the first two blocks we created a Synthetic PI Interaction Index (SPIII). Bivariate and multivariate analysis of logistic regression. RESULTS: 350 resident's responses (28% family and community medicine [FCM], 57% hospital, 15% others). Ninety-eight percent reported interacting with the PI. Twenty percent believed their prescribing was influenced by the PI and 48% believed it was influenced by other doctors. Sixty-five precent considered more training necessary. Ninety-six percent had received no information from their college of physicians, 80% did not know the regulations in their medical society and 50% were unaware of those of their institution. Hospital specialty residents showed more likelihood of SPIII ≥ percentile 75 than those of FCM (odds ratio [OR]: 3.96; 95% confidence interval [95%CI]: 1.88-8.35). Training in informal settings was associated with SPIII ≤ percentile 25 (OR: 2.83; 95%CI: 1.32-6.07). CONCLUSIONS: The medical residents in RM had a high level of interaction with the PI and believed its influence low. Hospital specialty residents showed more interaction with the PI. Regulations were not well known by residents and they consideredmore training necessary.


Subject(s)
Attitude of Health Personnel , Drug Industry , Internship and Residency , Medicine , Adult , Cross-Sectional Studies , Female , Humans , Male , Self Report , Spain , Urban Population
7.
Implement Sci ; 12(1): 54, 2017 04 27.
Article in English | MEDLINE | ID: mdl-28449721

ABSTRACT

BACKGROUND: Multimorbidity is associated with negative effects both on people's health and on healthcare systems. A key problem linked to multimorbidity is polypharmacy, which in turn is associated with increased risk of partly preventable adverse effects, including mortality. The Ariadne principles describe a model of care based on a thorough assessment of diseases, treatments (and potential interactions), clinical status, context and preferences of patients with multimorbidity, with the aim of prioritizing and sharing realistic treatment goals that guide an individualized management. The aim of this study is to evaluate the effectiveness of a complex intervention that implements the Ariadne principles in a population of young-old patients with multimorbidity and polypharmacy. The intervention seeks to improve the appropriateness of prescribing in primary care (PC), as measured by the medication appropriateness index (MAI) score at 6 and 12 months, as compared with usual care. METHODS/DESIGN: Design: pragmatic cluster randomized clinical trial. Unit of randomization: family physician (FP). Unit of analysis: patient. SCOPE: PC health centres in three autonomous communities: Aragon, Madrid, and Andalusia (Spain). POPULATION: patients aged 65-74 years with multimorbidity (≥3 chronic diseases) and polypharmacy (≥5 drugs prescribed in ≥3 months). SAMPLE SIZE: n = 400 (200 per study arm). INTERVENTION: complex intervention based on the implementation of the Ariadne principles with two components: (1) FP training and (2) FP-patient interview. OUTCOMES: MAI score, health services use, quality of life (Euroqol 5D-5L), pharmacotherapy and adherence to treatment (Morisky-Green, Haynes-Sackett), and clinical and socio-demographic variables. STATISTICAL ANALYSIS: primary outcome is the difference in MAI score between T0 and T1 and corresponding 95% confidence interval. Adjustment for confounding factors will be performed by multilevel analysis. All analyses will be carried out in accordance with the intention-to-treat principle. DISCUSSION: It is essential to provide evidence concerning interventions on PC patients with polypharmacy and multimorbidity, conducted in the context of routine clinical practice, and involving young-old patients with significant potential for preventing negative health outcomes. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02866799.


Subject(s)
Chronic Disease/drug therapy , Drug Prescriptions/statistics & numerical data , Drug Prescriptions/standards , Patient-Centered Care/statistics & numerical data , Patient-Centered Care/standards , Primary Health Care/statistics & numerical data , Primary Health Care/standards , Aged , Aged, 80 and over , Female , Humans , Male , Multimorbidity , Outcome Assessment, Health Care , Polypharmacy , Spain
8.
Implement Sci ; 11: 71, 2016 May 17.
Article in English | MEDLINE | ID: mdl-27189180

ABSTRACT

BACKGROUND: Clinical practice guidelines (CPGs) have been developed with the aim of helping health professionals, patients, and caregivers make decisions about their health care, using the best available evidence. In many cases, incorporation of these recommendations into clinical practice also implies a need for changes in routine clinical practice. Using educational games as a strategy for implementing recommendations among health professionals has been demonstrated to be effective in some studies; however, evidence is still scarce. The primary objective of this study is to assess the effectiveness of a teaching strategy for the implementation of CPGs using educational games (e-learning EDUCAGUIA) to improve knowledge and skills related to clinical decision-making by residents in family medicine. The primary objective will be evaluated at 1 and 6 months after the intervention. The secondary objectives are to identify barriers and facilitators for the use of guidelines by residents of family medicine and to describe the educational strategies used by Spanish teaching units of family and community medicine to encourage implementation of CPGs. METHODS/DESIGN: We propose a multicenter clinical trial with randomized allocation by clusters of family and community medicine teaching units in Spain. The sample size will be 394 residents (197 in each group), with the teaching units as the randomization unit and the residents comprising the analysis unit. For the intervention, both groups will receive an initial 1-h session on clinical practice guideline use and the usual dissemination strategy by e-mail. The intervention group (e-learning EDUCAGUIA) strategy will consist of educational games with hypothetical clinical scenarios in a virtual environment. The primary outcome will be the score obtained by the residents on evaluation questionnaires for each clinical practice guideline. Other included variables will be the sociodemographic and training variables of the residents and the teaching unit characteristics. The statistical analysis will consist of a descriptive analysis of variables and a baseline comparison of both groups. For the primary outcome analysis, an average score comparison of hypothetical scenario questionnaires between the EDUCAGUIA intervention group and the control group will be performed at 1 and 6 months post-intervention, using 95 % confidence intervals. A linear multilevel regression will be used to adjust the model. DISCUSSION: The identification of effective teaching strategies will facilitate the incorporation of available knowledge into clinical practice that could eventually improve patient outcomes. The inclusion of information technologies as teaching tools permits greater learning autonomy and allows deeper instructor participation in the monitoring and supervision of residents. The long-term impact of this strategy is unknown; however, because it is aimed at professionals undergoing training and it addresses prevalent health problems, a small effect can be of great relevance. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02210442 .


Subject(s)
Clinical Decision-Making/methods , Community Medicine/education , Family Practice/education , Games, Experimental , Health Plan Implementation/methods , Internship and Residency/methods , Follow-Up Studies , Humans , Practice Guidelines as Topic , Program Evaluation , Spain , Surveys and Questionnaires
9.
BMC Nurs ; 13(1): 2, 2014 Jan 27.
Article in English | MEDLINE | ID: mdl-24467767

ABSTRACT

BACKGROUND: In Spain, family is the main source of care for dependent people. Numerous studies suggest that providing informal (unpaid) care during a prolonged period of time results in a morbidity-generating burden. Caregivers constitute a high-risk group that experiences elevated stress levels, which reduce their quality of life.Different strategies have been proposed to improve management of this phenomenon in order to minimize its impact, but definitive conclusions regarding their effectiveness are lacking. METHODS/DESIGN: A community clinical trial is proposed, with a 1-year follow-up period, that is multicentric, controlled, parallel, and with randomized allocation of clusters in 20 health care centers within the Community of Madrid. The study's objective is to evaluate the effectiveness of a standard care intervention in primary health care (intervention CuidaCare) to improve the quality of life of the caregivers, measured at 0, 6, and 12 months after the intervention.One hundred and forty two subjects (71 from each group) ≥65 years, identified by the nurse as the main caregivers, and who provide consent to participate in the study will be included.The main outcome variable will be perceived quality of life as measured by the Visual Analogue Scale (VAS) of EuroQol-5D (EQ-5D). The secondary outcome variables will be EQ-5D Dimensions, EQ-5D Index, nursing diagnosis, and Zarit's test. Prognostic variables will be recorded for the dependent patient and the caregiver.The principle analysis will be done by comparing the average change in EQ-5D VAS value before and after intervention between the two groups. All statistical tests will be performed as intention-to-treat. Prognostic factors' estimates will be adjusted by mixed-effects regression models. Possible confounding or effect-modifying factors will be taken into account. DISCUSSION: Assistance for the caregiver should be integrated into primary care services. In order to do so, incorporating standard, effective interventions with relevant outcome variables such as quality of life is necessary. Community care nurses are at a privileged position to develop interventions like the proposed one. TRIAL REGISTRATION: This trial has been registered in ClinicalTrials.gov under code number NCT 01478295.

10.
J Clin Nurs ; 22(15-16): 2114-21, 2013 Aug.
Article in English | MEDLINE | ID: mdl-23829402

ABSTRACT

AIMS AND OBJECTIVES: To determine the effect of a seven-week-long, group-delivered, nurse-monitored, exercise training programme on the adherence of obese women to physical exercise routines at 12 months. BACKGROUND: The worldwide obesity epidemic is posing huge public health challenges. The main cause of obesity in Europe is very possibly a sedentary lifestyle. Uncertainty exists regarding whether people will continue to exercise once a structured intervention programme of physical activity ends. DESIGN: No-control-group (before-after) intervention study. METHODS: One Hundred Seventy-Four women from the Madrid region (Spain) aged ≥ 45 years with a body mass index of ≥30 undertook a maximum of 21 × 1 hour exercise training programme sessions (three per week) over seven weeks starting in February 2009. The number of women making use of exercise training programme before the intervention, and at 6 and 12 months postintervention, was recorded using the Nursing Outcome Classification. Information was collected by interviewing the study subjects. Bivariate (McNemar and Student's t-tests) and multivariate (binary logistic regression) analyses were then performed. RESULTS: The Nursing Outcome Classification Indicator 'Does the subject follow an exercise training programme?' showed that at the end of one year, the percentage of women who remained adhered to exercise training programme increased in those who completed the study (from 11-41%). As the number of programmed exercise training programme sessions completed increased beyond 14, so too did the likelihood of adhering to an exercise training programme regime at one year. CONCLUSION: The results show that an exercise training programme intervention can encourage obese women to continue exercising after exercise interventions end. RELEVANCE TO CLINICAL PRACTICE: This type of intervention could provide a valuable means of helping women lose weight and improve their health. It may also have important economic benefits for health systems. Clinical trials with longer follow-up times and in other populations are needed to confirm the present results.


Subject(s)
Exercise , Obesity/therapy , Patient Compliance , Primary Health Care/organization & administration , Psychotherapy, Group , Body Mass Index , Female , Humans , Middle Aged , Obesity/psychology , Spain
11.
BMC Public Health ; 12: 394, 2012 May 31.
Article in English | MEDLINE | ID: mdl-22650964

ABSTRACT

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.


Subject(s)
Quality of Life , Vitamin B 12 Deficiency/drug therapy , Vitamin B 12/therapeutic use , Vitamin B Complex/therapeutic use , Administration, Oral , Aged , Comparative Effectiveness Research , Drug Administration Routes , Female , Humans , Injections, Intramuscular , Male , Patient Compliance , Patient Satisfaction , Primary Health Care , Quality of Life/psychology , Research Design , Sample Size , Socioeconomic Factors , Treatment Outcome , Vitamin B 12/administration & dosage , Vitamin B 12/blood , Vitamin B 12 Deficiency/epidemiology , Vitamin B Complex/administration & dosage
12.
Aten. prim. (Barc., Ed. impr.) ; 43(3): 117-124, mar. 2011. tab, graf
Article in Spanish | IBECS | ID: ibc-88423

ABSTRACT

ObjetivoIdentificar factores asociados a reingreso hospitalario en personas de edad avanzada.DiseñoEstudio observacional descriptivo.EmplazamientoÁrea sanitaria 3 de Madrid.ParticipantesPacientes mayores de 74 años que han ingresado en el Hospital Universitario Príncipe de Asturias en 2006. Se han excluido aquellos con ingreso en los 6 meses previos. Participaron 1.051 pacientes.Mediciones principalesSe utilizaron el conjunto mínimo básico de datos al alta hospitalaria y el sistema de información de atención primaria para desarrollar modelos de regresión logística. La variable dependiente fue reingreso en seis meses y las variables independientes fueron sociodemográficas, de estado de salud del paciente, y de la actividad asistencial.ResultadosEl 22,6% reingresaron en los seis primeros meses. Las variables que se asocian con mayor fuerza al reingreso fueron la estancia hospitalaria (estancias superiores a 15 días presentan un OR: 1,73; IC del 95%: 1,17–2,54), el total de fármacos prescritos al paciente (OR: 1,05; IC del 95%: 1,01–1,09), padecer hipertensión (OR:1,56; IC del 95%: 1,11–2,18), insuficiencia cardiaca (OR: 1,56; IC del 95%: 1,00–2,44) o cardiopatía isquémica (OR: 1,51; IC del 95%: 1,00–2,26), y la presión asistencial media de enfermería (OR: 0,93; IC del 95%: 0,87–0,98). El modelo que identifica mayor número de factores asociados al reingreso es el que integra información de ambos sistemas.ConclusionesLos reingresos hospitalarios se han asociado a condiciones propias del paciente y a factores derivados de la asistencia sanitaria recibida. Integrar información de bases de datos clínico-administrativas de atención primaria y hospitalaria mejora la capacidad para identificar factores asociados con un mayor riesgo de reingreso que podrían servir para plantear estrategias(AU)


ObjectiveTo identify factors associated with hospital readmissions in the elderly.DesignObservational descriptive study.SettingHealth area 3 of Madrid.ParticipantsPatients 74 years-old and over with a hospital admission to Hospital Universitario Príncipe de Asturias in 2006. Those with a hospital admission in the previous 6 months were excluded. A total of 1051 patients were identified.Main MeasuresHospital Discharge Minimum Basic Data Set and primary care information system were used to develop logistical regression models. The dependent variable was the hospital readmission in a 6 month period. Independent variables were socio-demographics, health status and health care activity.ResultsThere were 22.6% readmissions in the first 6 months. Variables associated with higher risk of readmission were, hospital stay (hospital stay greater than 15 days had an OR: 1.73 (95% CI:1.17–2.54), the total number of medicines prescribed to the patient (OR: 1.05; 95% CI:1.01–1.09), having hypertension (OR:1.56; 95% CI:1.11–2.18), heart failure (OR: 1.56; 95% CI:1.00–2.44) or ischemic heart disease (OR: 1.51; 95% CI:1.00–2.26), and the primary care nursing mean attendance pressure (OR: 0.93; 95% CI:0.87–0.98). The model that integrates information from both systems explains a higher number of factors associated with readmission.ConclusionsHospital readmissions have been associated to patient medical condition and to factors related to the health care received. Integrating information from hospital and primary care administrative data bases improves the capacity to identify factors associated with a higher readmission risk(AU)


Subject(s)
Humans , Male , Female , Aged , Aged, 80 and over , Patient Readmission/statistics & numerical data , Patient Care Management/methods , Health of the Elderly , /statistics & numerical data , Primary Health Care/statistics & numerical data , Risk Factors
13.
Aten Primaria ; 43(3): 117-24, 2011 Mar.
Article in Spanish | MEDLINE | ID: mdl-20307916

ABSTRACT

OBJECTIVE: To identify factors associated with hospital readmissions in the elderly. DESIGN: Observational descriptive study. SETTING: Health area 3 of Madrid. PARTICIPANTS: Patients 74 years-old and over with a hospital admission to Hospital Universitario Príncipe de Asturias in 2006. Those with a hospital admission in the previous 6 months were excluded. A total of 1051 patients were identified. MAIN MEASURES: Hospital Discharge Minimum Basic Data Set and primary care information system were used to develop logistical regression models. The dependent variable was the hospital readmission in a 6 month period. Independent variables were socio-demographics, health status and health care activity. RESULTS: There were 22.6% readmissions in the first 6 months. Variables associated with higher risk of readmission were, hospital stay (hospital stay greater than 15 days had an OR: 1.73 (95% CI:1.17-2.54), the total number of medicines prescribed to the patient (OR: 1.05; 95% CI:1.01-1.09), having hypertension (OR:1.56; 95% CI:1.11-2.18), heart failure (OR: 1.56; 95% CI:1.00-2.44) or ischemic heart disease (OR: 1.51; 95% CI:1.00-2.26), and the primary care nursing mean attendance pressure (OR: 0.93; 95% CI:0.87-0.98). The model that integrates information from both systems explains a higher number of factors associated with readmission. CONCLUSIONS: Hospital readmissions have been associated to patient medical condition and to factors related to the health care received. Integrating information from hospital and primary care administrative data bases improves the capacity to identify factors associated with a higher readmission risk.


Subject(s)
Patient Readmission/statistics & numerical data , Aged , Aged, 80 and over , Female , Humans , Male , Risk Factors
14.
BMC Public Health ; 10: 449, 2010 Jul 30.
Article in English | MEDLINE | ID: mdl-20673325

ABSTRACT

BACKGROUND: High blood pressure (HBP) is a major risk factor for cardiovascular disease (CVD). European hypertension and cardiology societies as well as expert committees on CVD prevention recommend stratifying cardiovascular risk using the SCORE method, the modification of lifestyles to prevent CVD, and achieving good control over risk factors. The EDUCORE (Education and Coronary Risk Evaluation) project aims to determine whether the use of a cardiovascular risk visual learning method--the EDUCORE method--is more effective than normal clinical practice in improving the control of blood pressure within one year in patients with poorly controlled hypertension but no background of CVD; METHODS/DESIGN: This work describes a protocol for a clinical trial, randomised by clusters and involving 22 primary healthcare clinics, to test the effectiveness of the EDUCORE method. The number of patients required was 736, all between 40 and 65 years of age (n = 368 in the EDUCORE and control groups), all of whom had been diagnosed with HBP at least one year ago, and all of whom had poorly controlled hypertension (systolic blood pressure >or= 140 mmHg and/or diastolic >or= 90 mmHg). All personnel taking part were explained the trial and trained in its methodology. The EDUCORE method contemplates the visualisation of low risk SCORE scores using images embodying different stages of a high risk action, plus the receipt of a pamphlet explaining how to better maintain cardiac health. The main outcome variable was the control of blood pressure; secondary outcome variables included the SCORE score, therapeutic compliance, quality of life, and total cholesterol level. All outcome variables were measured at the beginning of the experimental period and again at 6 and 12 months. Information on sex, age, educational level, physical activity, body mass index, consumption of medications, change of treatment and blood analysis results was also recorded; DISCUSSION: The EDUCORE method could provide a simple, inexpensive means of improving blood pressure control, and perhaps other health problems, in the primary healthcare setting; TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov, number NCT01155973 [http://ClinicalTrials.gov].


Subject(s)
Hypertension/therapy , Learning , Primary Health Care , Program Evaluation , Vision, Ocular , Adult , Aged , Cardiovascular Diseases/prevention & control , Humans , Hypertension/diagnosis , Middle Aged , Spain
17.
Rev Calid Asist ; 24(4): 155-61, 2009 Aug.
Article in Spanish | MEDLINE | ID: mdl-19647677

ABSTRACT

OBJECTIVE: To analyze patient complaints in a Primary Health Care District (PHCD) using statistical process control methods compared to multivariate methods, as regards their results and feasibility of application in this context. MATERIAL AND METHOD: Descriptive study based on an aggregate analysis of administrative complaints. SETTING: Complaints received between January 2005 and August 2008 in the Customer Management Department in the 3rd PHCD Management Office, Madrid Health Services. Complaints are registered through Itrack, a computer software tool used throughout the whole Community of Madrid. MAIN VARIABLES: Total number of complaints, complaints sorted by Reason and Primary Health Care Team (PHCT), total number of patient visits (including visits on demand, appointment visits and home visits) and visits by PHCT and per month and year. STATISTICAL ANALYSIS: Multivariate analysis and control charts were used. RESULTS: 44-month time series with a mean of 76 complaints per month, an increasing trend in the first three years and decreasing during summer months. Poisson regression detected an excess of complaints in 8 out of the 44 months in the series. The control chart detected the same 8 months plus two additional ones. CONCLUSIONS: Statistical process control can be useful for detecting an excess of complaints in a PHCD and enables comparisons to be made between different PHC teams. As it is a simple technique, it can be used for ongoing monitoring of customer perceived quality.


Subject(s)
Patient Satisfaction/statistics & numerical data , Primary Health Care/organization & administration , Process Assessment, Health Care/statistics & numerical data , Quality Assurance, Health Care/organization & administration , Computer Graphics , Feasibility Studies , Humans , Multivariate Analysis , Office Visits/statistics & numerical data , Poisson Distribution , Primary Health Care/statistics & numerical data , Quality Assurance, Health Care/statistics & numerical data , Retrospective Studies , Seasons , Software , Spain
18.
Rev. calid. asist ; 24(4): 155-161, jul.-ago. 2009. ilus, graf
Article in Spanish | IBECS | ID: ibc-62094

ABSTRACT

Objetivo: Analizar las reclamaciones de un área de atención primaria mediante técnicas de control estadístico de procesos, y compararlas con técnicas multivariables en cuanto a sus resultados y su factibilidad de aplicación en este medio. Material y método: Estudio descriptivo con análisis agregado de las reclamaciones administrativas. Período del estudio: reclamaciones recibidas desde enero de 2005 a agosto de 2008. Fuente de datos: la Unidad de Gestión de Usuarios de la Gerencia de Atención Primaria Área 3, Servicio Madrileño de Salud registra las reclamaciones en el programa track, utilizado en toda la Comunidad de Madrid. Mediciones principales: número total de reclamaciones, reclamaciones por motivo y por equipo de atención primaria, número de consultas totales (incluye consultas a demanda, concertadas y domicilio) y consultas por EAP, mes y año. Análisis estadístico: aplicación de técnicas multivariables y gráficos de control. Resultados: Serie temporal de 44 meses con una mediana de 76 reclamaciones/mes, una tendencia incremental en los primeros 3 años y descensos durante el verano. La regresión de Poisson permite detectar un exceso de reclamaciones en 8 de los 44 meses de la serie. El gráfico de control identifica los mismos puntos y 2 adicionales. Conclusiones: El control estadístico de procesos puede resultar útil para detectar excesos de reclamaciones en un área de salud y comparar entre unidades asistenciales. Su fácil aplicación permite realizar una monitorización continua de la calidad percibida por los usuarios (AU)


Objective: To analyze patient complaints in a Primary Health Care District (PHCD) using statistical process control methods compared to multivariate methods, as regards their results and feasibility of application in this context. Material and method: Descriptive study based on an aggregate analysis of administrative complaints. Setting: Complaints received between January 2005 and August 2008 in the Customer Management Department in the 3 rd PHCD Management Office, Madrid Health Services. Complaints are registered through track, a computer software tool used throughout the whole Community of Madrid. Main variables: Total number of complaints, complaints sorted by Reason and Primary Health Care Team (PHCT), total number of patient visits(including visits on demand, appointment visits and home visits) and visits by PHCT and per month and year. Statistical analysis: Multivariate analysis and control charts were used. Results: 44-month time series with a mean of 76 complaints per month, an increasing trend in the first three years and decreasing during summer months. Poisson regression detected an excess of complaints in 8 out of the 44 months in the series. The control chart detected the same 8 months plus two additional ones. Conclusions: Statistical process control can be useful for detecting an excess of complaints in a PHCD and enables comparisons to be made between different PHC teams. As it is a simple technique, it can be used for ongoing monitoring of customer perceived quality (AU)


Subject(s)
Humans , Male , Female , Primary Health Care/statistics & numerical data , Primary Health Care/trends , 28599 , Logistic Models , Delivery of Health Care/statistics & numerical data , Feasibility Studies
19.
Aten Primaria ; 40(10): 511-5, 2008 Oct.
Article in Spanish | MEDLINE | ID: mdl-19054458

ABSTRACT

OBJECTIVE: To determine the prevalence of diabetic autonomic neuropathy (DAN) in patients with type 2 diabetes using a cardiovascular test. DESIGN: Observational, descriptive, cross-sectional study. SETTING: Primary care clinics in Fronteras de Torrejón de Ardoz Health Centre, Area 3, Madrid, Spain. PARTICIPANTS: Of the 361 diabetics assigned to 3 participating patient quotas, 317 patients had type 2 diabetes. Of those, 104 were excluded due to being immobile, cardiac arrhythmia, and/or on treatment with chronotropic drugs. Of the 213 patients included, 169 had the test and 44 were lost. INTERVENTIONS: Performing of the orthostatic response test. MAIN MEASUREMENTS: Age, sex, years since diagnosed with diabetes (measured by patient anamnesis), treatment (hygiene-diet measures, oral antidiabetics, insulin) were recorded, along with the R-R'30:15 ratio (classified as normal: 31.04, borderline: 1.01 to 1.03, and pathological: pound1.00). RESULTS: The prevalence of DAN using the orthostatic response test was 56.2% (95 patients with a pathological R-R'30:15 index) out of a total of 169 patients with type 2 diabetes. The definitive diagnosis of DAN found in the clinical histories reviewed was 1.8%. CONCLUSIONS: DAN goes unnoticed in our evaluation of the patient with diabetes. The improvement in diagnosing this complication and incorporating cardiovascular autonomic dysfunction tests in primary care follow-up protocols, would enable closer metabolic control and improve the prognosis of the disease.


Subject(s)
Autonomic Nervous System Diseases/diagnosis , Autonomic Nervous System Diseases/etiology , Diabetes Mellitus, Type 2/complications , Diabetic Neuropathies/diagnosis , Diabetic Neuropathies/etiology , Primary Health Care , Aged , Cross-Sectional Studies , Female , Humans , Male
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