Efectividad de la terapia manual y de la electroestimulación nerviosa transcutánea en la reducción del dolor en pacientes con cervicalgia mecánica: ensayo clínico aleatorio en atención primaria

Objetivo: Evaluar la efectividad de la terapia manual y de la electroestimulación nerviosa transcutánea (TENS) en la disminución de la intensidad del dolor en pacientes con cervicalgia mecánica subaguda o crónica atendidos en Unidades de Fisioterapia de atención primaria, tanto a corto (al finalizar la terapia) como a medio plazo (a los 6 meses). Diseño: Ensayo clínico multicéntrico con grupos paralelos, asignación aleatoria y evaluación ciega de la variable respuesta. Emplazamiento: 13 Unidades de Fisioterapia de atención primaria de la Comunidad de Madrid. Pacientes: sujetos entre 18 y 60 años, con cervicalgia mecánica sin sufrimiento del tejido neural que precisaron ser atendidos en las Unidades de Fisioterapia. Intervenciones. La aplicación de terapia manual o TENS fue realizada por los fisioterapeutas de las unidades implicadas en el estudio. Cada fisioterapeuta aplicó ambas terapias indistintamente. Mediciones principales: Intensidad del dolor antes y después de la intervención: media de los valores de la Escala Visual Analógica, EVA (momento actual, promedio y peor dolor de las últimas 2 semanas). Estado de salud mediante el cuestionario abreviado SF-12. Efectos adversos. Expectativas del paciente y satisfacción con el tratamiento recibido. Características sociodemográficas y variables pronóstico clínicas por grupo de intervención. Resultados: Se incluyeron un total de 90 pacientes con cervicalgia mecánica, 47 pacientes recibieron tratamiento con terapia manual y 43 con TENS. Un 79% de los pacientes completaron el seguimiento del estudio a los seis meses. Las características de los pacientes asignados a ambos grupos al inicio son homogéneas (sin diferencias estadísticamente significativas). Las dos técnicas producen una reducción de la intensidad del dolor clínicamente relevante (descenso del dolor superior a 20 mm en la EVA de 0 a 100 mm, en ambos grupos), a corto plazo. La tasa de éxito disminuyó a un tercio de los pacientes a medio plazo. La reducción media del dolor en ambos grupos (15 mm en el grupo de terapia manual y 13 mm en el grupo de TENS) deja de tener relevancia clínica a medio plazo. No se observan diferencias entre las distintas terapias, ni a corto ni a medio plazo. Conclusiones: La utilización tanto del TENS como de la terapia manual produce una disminución de la intensidad del dolor percibido, a corto y a medio plazo; sin embargo, esta reducción es solo clínicamente relevante al finalizar la intervención (a corto plazo). El estado de salud de los pacientes con cervicalgia mecánica, tanto al inicio como al finalizar el estudio es inferior al de la población general. Se observó una mejoría en ambos componentes del SF-12 (físico y mental), tanto a corto como a medio plazo en el grupo que recibió terapia manual. No obstante, tanto a corto como a medio plazo las mejorías observadas fueron pequeñas y no se encontraron diferencias entre ambas terapias. Los efectos adversos derivados de la aplicación de ambas terapias fueron poco frecuentes y con escasa relevancia clínica. El grado de satisfacción de los pacientes con la intervención fue elevado. Los pacientes que experimentaron una mayor reducción del dolor se mostraron más satisfechos, independientemente del tipo de intervención aplicada, terapia manual o TENS y de sus expectativas previas o de otras características

Efectividad de la terapia manual y de la electroestimulación nerviosa transcutánea en la reducción del dolor en pacientes con cervicalgia mecánica: ensayo clínico aleatorio en atención primaria

Objetivo: Evaluar la efectividad de la terapia manual y de la electroestimulación nerviosa transcutánea (TENS) en la disminución de la intensidad del dolor en pacientes con cervicalgia mecánica subaguda o crónica atendidos en Unidades de Fisioterapia de atención primaria, tanto a corto (al finalizar la terapia) como a medio plazo (a los 6 meses). Diseño: Ensayo clínico multicéntrico con grupos paralelos, asignación aleatoria y evaluación ciega de la variable respuesta. Emplazamiento: 13 Unidades de Fisioterapia de atención primaria de la Comunidad de Madrid. Pacientes: sujetos entre 18 y 60 años, con cervicalgia mecánica sin sufrimiento del tejido neural que precisaron ser atendidos en las Unidades de Fisioterapia. Intervenciones. La aplicación de terapia manual o TENS fue realizada por los fisioterapeutas de las unidades implicadas en el estudio. Cada fisioterapeuta aplicó ambas terapias indistintamente. Mediciones principales: Intensidad del dolor antes y después de la intervención: media de los valores de la Escala Visual Analógica, EVA (momento actual, promedio y peor dolor de las últimas 2 semanas). Estado de salud mediante el cuestionario abreviado SF-12. Efectos adversos. Expectativas del paciente y satisfacción con el tratamiento recibido. Características sociodemográficas y variables pronóstico clínicas por grupo de intervención. Resultados: Se incluyeron un total de 90 pacientes con cervicalgia mecánica, 47 pacientes recibieron tratamiento con terapia manual y 43 con TENS. Un 79% de los pacientes completaron el seguimiento del estudio a los seis meses. Las características de los pacientes asignados a ambos grupos al inicio son homogéneas (sin diferencias estadísticamente significativas). Las dos técnicas producen una reducción de la intensidad del dolor clínicamente relevante (descenso del dolor superior a 20 mm en la EVA de 0 a 100 mm, en ambos grupos), a corto plazo. La tasa de éxito disminuyó a un tercio de los pacientes a medio plazo. La reducción media del dolor en ambos grupos (15 mm en el grupo de terapia manual y 13 mm en el grupo de TENS) deja de tener relevancia clínica a medio plazo. No se observan diferencias entre las distintas terapias, ni a corto ni a medio plazo. Conclusiones: La utilización tanto del TENS como de la terapia manual produce una disminución de la intensidad del dolor percibido, a corto y a medio plazo; sin embargo, esta reducción es solo clínicamente relevante al finalizar la intervención (a corto plazo). El estado de salud de los pacientes con cervicalgia mecánica, tanto al inicio como al finalizar el estudio es inferior al de la población general. Se observó una mejoría en ambos componentes del SF-12 (físico y mental), tanto a corto como a medio plazo en el grupo que recibió terapia manual. No obstante, tanto a corto como a medio plazo las mejorías observadas fueron pequeñas y no se encontraron diferencias entre ambas terapias. Los efectos adversos derivados de la aplicación de ambas terapias fueron poco frecuentes y con escasa relevancia clínica. El grado de satisfacción de los pacientes con la intervención fue elevado. Los pacientes que experimentaron una mayor reducción del dolor se mostraron más satisfechos, independientemente del tipo de intervención aplicada, terapia manual o TENS y de sus expectativas previas o de otras características

The pharmaceutical industry and specialised medical training: Residents' perceptions in Madrid, Spain.

[ES] 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. [EN] 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. 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. 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). 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.S

Satisfaction of patients with mechanical neck disorders attended to by primary care physical therapists

8 p.Objective: To describe the satisfaction and expectations of the patients with neck pain with relation to the physical therapy received and to analyse the relationship between the patient's characteristics and his degree of satisfaction and expectation. Design: This study is performed in the setting of a random clinical trial. Participants: Subjects between 18 and 60 years of age with subacute mechanical neck disorders. Main variables: Patient's expectations and satisfaction with the received treatment (scale similar to Likert's Scale). OTHER VARIABLES: Pain intensity, episodes of previous neck pain, depression and anxiety symptoms (Goldberg Scale), age and gender, physical disability, general state of health, duration of the present episode of neck pain, regular exercise and regular consumption of medicines. Results and conclusions: A total of 90 patients were studied. The mean age was 40.1 years and 88.9% were female. Thirteen per cent of the subjects expected partial relief, 60% expected good recovery and 27% expected complete recovery. Those patients who have not suffered previous episodes of neck pain and those who have a higher score on the Goldberg Scale have a higher expectation of recovering after the treatment. About patients' satisfaction after the intervention, 2% totally unsatisfied, 1% very unsatisfied, 2% somewhat unsatisfied, 2% indifferent, 17% somewhat satisfied, 42% very satisfied and 30% totally satisfied. Those patients who experienced a greater decrease in pain were more satisfied. It would be interesting to study in depth the measurement of patients' satisfaction with the received physical therapy and to extend it to other pathologies.Fondo de Investigación Sanitari

Professional interventions to implement guidelines to prevent hazardous alcohol consumption by patients in primary care settings (Protocol)

post-print90 K

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

The trial was financed by Ministerio de Sanidad y Consumo Español through their call for independent clinical research, Orden Ministerial SAS/2377, 2010 (EC10-115, EC10-116, EC10-117, EC10-119, EC10-122); CAIBER—Spanish Clinical Research Network, Instituto de Salud Carlos III (ISCIII) (CAI08/010044); and Gerencia Asistencial de Atención Primaria de Madrid. This study is also supported by the Spanish Clinical Research Network (SCReN), funded by ISCIII-Subdirección General de Evaluación y Fomento de la Investigación, project number PT13/0002/0007, within the National Research Program I+D+I 2013-2016 and co-funded with European Union ERDF funds (European Regional Development Fund). This project received a grant for the translation and publication of this article from the Foundation for Biomedical Research and Innovation in Primary Care (FIIBAP) Call 2017 for grants to promote research programs.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.Publisher PDFPeer reviewe

A primary healthcare information intervention for communicating cardiovascular risk to patients with poorly controlled hypertension: The Education and Coronary Risk Evaluation (Educore) study-A pragmatic, cluster-randomized trial

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.This study was funded by the Spanish Ministry of Science and Innovation via the Instituto de Salud Carlos III, Subprograma de Proyectos de Investigación en Evaluación de Tecnologías Sanitarias y Servicios de Salud (PI 09/90354), and the Fundación de Investigación e Innovación Biomédica en Atención Primaria (FIIBAP). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscriptS

EDUCORE project: a clinical trial, randomised by clusters, to assess the effect of a visual learning method on blood pressure control in the primary healthcare setting

<p>Abstract</p> <p>Background</p> <p>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;</p> <p>Methods/Design</p> <p>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 ≥ 140 mmHg and/or diastolic ≥ 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;</p> <p>Discussion</p> <p>The EDUCORE method could provide a simple, inexpensive means of improving blood pressure control, and perhaps other health problems, in the primary healthcare setting;</p> <p>Trial registration</p> <p>The trial was registered with ClinicalTrials.gov, number NCT01155973 [<url>http://ClinicalTrials.gov</url>].</p

Effectiveness of a strategy that uses educational games to implement clinical practice guidelines among Spanish residents of family and community medicine (e-EDUCAGUIA project):A clinical trial by clusters

This study was funded by the Fondo de Investigaciones Sanitarias FIS Grant Number PI11/0477 ISCIII.-REDISSEC Proyecto RD12/0001/0012 AND FEDER Funding.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 6months 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 6months 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.Publisher PDFPeer reviewe

Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy:Study protocol of a cluster randomized clinical trial (Multi-PAP project)

This study was funded by the Fondo de Investigaciones Sanitarias ISCIII (Grant Numbers PI15/00276, PI15/00572, PI15/00996), REDISSEC (Project Numbers RD12/0001/0012, RD16/0001/0005), and the European Regional Development Fund ("A way to build Europe").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 12months, 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 65-74years with multimorbidity (≥3 chronic diseases) and polypharmacy (≥5 drugs prescribed in ≥3months). 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, NCT02866799Publisher PDFPeer reviewe