Effectiveness of double-layered compression therapy against crepe bandage for healing venous ulcers in primary care. Randomized clinical trial

Objetivo: Evaluar si el vendaje de 2 capas es más efectivo que el vendaje de crepé en la cicatrización de úlceras venosas tras 12 semanas de seguimiento. Diseño: Ensayo clínico aleatorizado multicéntrico. Emplazamiento: 22 Centros de Salud de Madrid. Participantes: Mayores de 18 años, con diagnóstico de úlceras venosas. Se aleatorizaron 93 pacientes, 56 en el grupo de doble capa y 37 en crepé. Retiradas: 16 en el grupo de doble capa y 7 en el de crepé. Intervenciones: Grupo control: práctica clínica habitual: tratamiento de la herida y vendaje con crepé. Grupo experimental: misma práctica habitual para tratamiento de la herida y vendaje con doble capa. Mediciones principales: Variable respuesta principal: cicatrización completa a las 12 semanas. Variables secundarias: severidad de las lesiones, calidad de vida, reacciones adversas. Evaluación ciega de la variable respuesta. Resultados: Cicatrización completa: 25 (67%) en el grupo crepé (IC al 95% 50,2-81,9) y 32 (57,1%) en doble capa (IC al 95% 43,2-70,3). Sin diferencias en ambos grupos, RR = 1,10 (IC al 95% 0,864-1,424). La severidad de las úlceras basales se asocia al tiempo de cicatrización, HR = 0,86 (IC al 95% 0,78-0,94). Se objetiva mejora significativa en la calidad de vida total y en las dimensiones cosmesis y estado emocional. No se encuentran diferencias según el vendaje utilizado. Sin reacciones adversas graves en ninguno de los grupos. Conclusiones: No encontramos diferencias significativas en la cicatrización entre los 2 tipos de vendaje. Ambos son apropiados para la cicatrización de las úlceras y para mejorar la calidad de vida.Objective: To evaluate if the two-layer bandage is more effective than the crepe bandage in the healing of venous ulcers after 12 weeks of follow-up. Design: Randomized multicentre controlled clinical trial. Location: 22 Primary Health Centers of Madrid. Participants: Over 18 years old, with diagnosis of venous ulcers. 93 patients were randomized, 56 in the double layer group and 37 in the crepe group. Withdrawals: 16 in double layer group, 7 in crepe group. Interventions: Control group: usual clinical practice: treatment of the wound and bandage with crepe. Experimental group: same usual clinical practice for wound treatment and bandage with double layer. Main measurements: Primary outcome: complete healing at 12 weeks. Secondary outcomes: severity of ulceration, health-related quality of life, adverse events. Blind evaluation of the response variable. Results: Complete healing: in crepe group, 25, 67.5% (95% CI 50.2-81.9) and in double layer group, 32, 57.1% (95% CI 43.2-70.3). No evidence of a difference in both groups, RR = 1.10 (95% CI 0.864-1.424). The basal severity of the ulcers is associated with the healing time. HR = 0.86 (95% CI 0.78-0.94). Our data showed a significant improvement in health-related quality of life, total and in the of cosmesis and emotional dimensions. No evidence of a difference in both groups. We didn’t find serious adverse events in any of the groups. Conclusions: We didn’t find significant differences in the healing between the two bandages evaluated. Both are appropriate for ulcer healing and to improve the health-related quality of life.Financiado por el Ministerio de Ciencia e Innovación, a través del Instituto de Salud Carlos III. PN de I+D+I 2008-2011 Cofinanciado con fondos FEDER (PI13/01975) y la Fundación para la Investigación e Innovación Biosanitaria de Atención Primaria de la Comunidad de Madrid (FIIBAP)

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

Incidence of diabetes in patients treated with antipsychotics in primary care

Cartas al directorS

A Comparison of Methods for Modeling Factors Associated with Hospital Admissions in Incident Cases of Heart Failure

OBJECTIVE: Heart failure (HF) is an important public health problem due to its increasing prevalence, and the decompensation associated with hospital admission represents an increased risk of death. The objective of this study was to compare several methods to model the variable hospitalizations and to determine the effect of factors associated with hospital admissions in incident cases of HF. METHODS: Study of a retrospective cohort of patients with information extracted from electronic medical records of PC was performed. Patients 24 year and older with at least 1 visit to PC in 2006 were included. Registered hospital admissions of HF incident cases between 2006 and 2010 or until death were analyzed and comparison of Poisson, Negative Binomial (NB), zero-inflated and Hurdle regression models were conducted to identify factors associated con hospitalizations. RESULTS: 3,061 patients were identified in a cohort of 227,984. Regarding the factors associated with hospitalizations and according to the zero inflated NB regression model, patients who presented valvular disease (OR=2.01; CI95% 1.22-3.30), or were being treated with antithrombotics (OR=3.45; CI95%: 1.61-7.42) or diuretics (OR=2.28; CI95% 1.13-4.58) had a lower likelihood of hospitalization. Factors associated with a higher rate of hospital admissions were having valvular disease (IRR=1.37; CI95% 1.03-1.81) or diabetes (IRR=1.38; 1.07-1.78), and being treated with calcium antagonists (IRR=1.35; CI95% 1.05- 1.73) or ACE inhibitors (IRR=1.43; CI95% 1.06- 1.92). Having being referred to a cardiologist had a protective effect (IRR=0.86; CI95% 0.76- 0.97). CONCLUSIONS: The regression model that obtained the best adjustment was the zero inflated NB. According to this model, the factors associated with an increase in hospital admissions were valvulopathies, diabetes and treatment with calcium antagonists.Financiación: REDISSEC (RETIC RD12/0001) y BRIGE HEALTH (Programa de Salud de la Unión Europea (2014-2020) proyecto 664691).S

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

ECAMulticapa: Effectiveness of double-layered compression therapy for healing venous ulcers in primary care: a Study Protocol

Background: Chronic venous insufficiency, in its final stage can cause venous ulcers. Venous ulcers have a prevalence of 0.5 % to 0.8 % in the general population, and increases starting at 60 years of age. This condition often causes increased dependency in affected individuals, as well as a perceived reduced quality of life and family overload. Local Treating chronic venous ulcers has 2 components: topically healing the ulcer and controlling the venous insufficiency. There is evidence that compressive therapy favours the healing process of venous ulcers. The studies we have found suggest that the use of multilayer bandage systems is more effective than the use of bandages with a single component, these are mostly using in Spain. Multilayer compression bandages with 2 layers are equally effective in the healing process of chronic venous ulcers as 4-layer bandages and are better tolerated and preferenced by patients. More studies are needed to specifically compare the 2-layer bandages systems in the settings where these patients are usually treated. Method/design: Randomised, controlled, parallel, multicentre clinical trial, with 12 weeks of follow-up and blind evaluation of the response variable. The objective is to assess the efficacy of multilayer compression bandages (2 layers) compared with crepe bandages, based on the incidence of healed venous ulcers in individuals treated in primary care nursing consultations, at 12 weeks of follow-up. The study will include 216 individuals (108 per branch) with venous ulcers treated in primary care nursing consultations. The primary endpoint is complete healing at 12 weeks of follow-up. The secondary endpoints are the degree of healing (Resvech.2), quality of life (CCVUQ-e), adverse reactions related to the healing process. Prognosis and demographic variables are also recorder. Effectiveness analysis using Kaplan-Meier curves, a log-rank test and a Cox regression analysis. The analysis was performed by intention to treat. Discussion: The study results can contribute to improving the care and quality of life of patients with venous ulcers, decreasing healing times and healthcare expenditure and contributing to the consistent treatment of these lesions. Trial registration: This study has been recorded in the Clinical Trials.gov site with the code NCT02364921. 17 February 2015.This study was funded by PN of I + D + I 2013–2016 and the ISCIII – Subdirección General de Evaluación y Fomento de la Investigación and FEDER funds (PI13/01975). Ministerio de Economia y Competitividad

Primary care randomized clinical trial: manual therapy effectiveness in comparison with TENS in patients with neck pain

This study investigated effectiveness of manual therapy (MT) with transcutaneous electrical nerve stimulation (TENS) to reduce pain intensity in patients with mechanical neck disorder (MND). A randomized multi-centered controlled clinical trial was performed in 12 Primary Care Physiotherapy Units in Madrid Region. Ninety patients were included with diagnoses of subacute or chronic MND without neurological damage, 47 patients received MT and 43 TENS. The primary outcome was pain intensity measured in millimeters using the Visual Analogue Scale (VAS). Also disability, quality of life, adverse effects and sociodemographic and prognosis variables were measured. Three evaluations were performed (before, when the procedure ?nished and six months after). Seventy-one patients (79%) completed the follow-up measurement at six months. In more than half of the treated patients the procedure had a clinically relevant ?short term? result after having ended the intervention, when either MT or TENS was used. The success rate decreased to one-third of the patients 6 months after the intervention. No differences can be found in the reduction of pain, in the decrease of disability nor in the quality of life between both therapies. Both analyzed physiotherapy techniques produce a short-term pain reduction that is clinically relevant.Ministerio de SanidadInstituto de Salud Carlos II

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

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

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