Antonio García-Ruiz

Efficacy and safety of a multifactor intervention to improve therapeutic adherence in patients with chronic obstructive pulmonary disease (COPD): protocol for the ICEPOC study

BackgroundLow therapeutic adherence to medication is very common. Clinical effectiveness is related to dose rate and route of administration and so poor therapeutic adherence can reduce the clinical benefit of treatment. The therapeutic adherence of patients with chronic obstructive pulmonary disease (COPD) is extremely poor according to most studies. The research about COPD adherence has mainly focussed on quantifying its effect, and few studies have researched factors that affect non-adherence. Our study will evaluate the effectiveness of a multifactor intervention to improve the therapeutic adherence of COPD patients.Methods/DesignA randomized controlled clinical trial with 140 COPD diagnosed patients selected by a non-probabilistic method of sampling. Subjects will be randomly allocated into two groups, using the block randomization technique. Every patient in each group will be visited four times during the year of the study. Intervention: Motivational aspects related to adherence (beliefs and behaviour): group and individual interviews; cognitive aspects: information about illness; skills: inhaled technique training. Reinforcement of the cognitive-emotional aspects and inhaled technique training will be carried out in all visits of the intervention group.DiscussionAdherence to a prescribed treatment involves a behavioural change. Cognitive, emotional and motivational aspects influence this change and so we consider the best intervention procedure to improve adherence would be a cognitive and emotional strategy which could be applied in daily clinical practice. Our hypothesis is that the application of a multifactor intervention (COPD information, dose reminders and reinforcing audiovisual material, motivational aspects and inhalation technique training) to COPD patients taking inhaled treatment will give a 25% increase in the number of patients showing therapeutic adherence in this group compared to the control group.We will evaluate the effectiveness of this multifactor intervention on patient adherence to inhaled drugs considering that it will be right and feasible to the clinical practice context.Trial registrationCurrent Controlled Trials ISCTN18841601

Cost-effectiveness analysis of antipsychotics in reducing schizophrenia relapses

BackgroundSchizophrenia is a severe form of mental illness which is associated with significant and long-lasting health, social and financial burdens.The aim of this project is to assess the efficiency of the antipsychotics used in Spain in reducing schizophrenia relapses under the Spanish Health System perspective.Material and methodsA decision-analytic model was developed to explore the relative cost-effectiveness of five antipsychotic medications, amisulpride, aripiprazole, olanzapine, paliperidone Extended-Release (ER) and risperidone, compared to haloperidol, over a 1-year treatment period among people living in Spain with schizophrenia. The transition probabilities for assessed therapies were obtained from the systemic review and meta-analysis performed by National Institute for Health and Clinical Excellence (NICE).ResultsPaliperidone ER was the option that yielded more quality-adjusted life years (QALYs) gained per patient (0.7573). In addition, paliperidone ER was the least costly strategy (€3,062), followed by risperidone (€3,194), haloperidol (€3,322), olanzapine (€3,893), amisulpride (€4,247) and aripiprazole (€4,712).In the incremental cost-effectiveness (ICE) analysis of the assessed antipsychotics compared to haloperidol, paliperidone ER and risperidone were dominant options. ICE ratios for other medications were €23,621/QALY gained, €91,584/QALY gained and €94,558/QALY gained for olanzapine, amisulpride and aripiprazole, respectively. Deterministic sensitivity analysis showed that risperidone is always dominant when compared to haloperidol. Paliperidone ER is also dominant apart from the exception of the scenario with a 20% decrease in the probability of relapses.ConclusionsOur findings may be of interest to clinicians and others interested in outcomes and cost of mental health services among patients with schizophrenia.Paliperidone ER and risperidone were shown to be dominant therapies compared to haloperidol in Spain. It is worthwhile to highlight that schizophrenia is a highly incapacitating disease and choosing the most appropriate drug and formulation for a particular patient is crucial.The availability of more accurate local epidemiological data on schizophrenia would allow a better adaptation of the model avoiding some of the assumptions taken in our work. Future research could be focused on this.

Is it possible to diagnose the therapeutic adherence of patients with COPD in clinical practice? A cohort study

BackgroundTherapeutic adherence of patients with chronic obstructive pulmonary disease (COPD) is poor. It is therefore necessary to determine the magnitude of non-adherence to develop strategies to correct this behaviour. The purpose of this study was to analyse the diagnostic validity of indirect adherence methods.MethodsSample: 195 COPD patients undergoing scheduled inhaled treatment attending 5 Primary Care Centres of Malaga, Spain. Variables: Sociodemographic profile, illness data, spirometry, quality of life (St. George Respiratory Questionnaire: SGRQ), and inhaled medication counting (count of dose/pill or electronic monitoring) were collected. The patients knowledge of COPD (Batalla test:BT),their attitude towards treatment (Morisky-Green test: MGT) and their self-reported therapeutic adherence (Haynes-Sackett test: HST) were used as methods of evaluating adherence. The follow-up consisted four visits over one year (the recruitment visit: V0; and after 1 month:V1; 6 months:V2; and 1 year:V3).ResultsThe mean age was 69.59 (95% CI, 68.29-70.89) years old and 93.8% were male. Other findings included: 85.4% had a low educational level, 23.6% were smokers, 71.5% mild-moderate COPD stage with a FEV1 = 56.86 (SD = 18.85); exacerbations per year = 1.41(95% CI, 1-1.8). The total SGRQ score was 44.96 (95% CI, 42.46-47.46), showing a mild self-perceived impairment in health. The prevalence of adherence (dose/pill count) was 68.1% (95% CI, 60.9-75.3) at V1, 80% (95% CI, 73-87) at V2 and 84% (95% CI, 77.9) at V3. The MGT showed a specificity of 67.34% at V1, 76.19% at V2 and 69.62% at V3. The sensitivity was 53.33% at V1, 66.66% at V2 and 33.33% at V3.The BT showed a specificity of 55.1% at V1, 70.23% at V2 and 67.09% at V3. The sensitivity was 68.88% at V1, 71.43% at V2 and 46.66% at V3. Considering both tests together, the specificity was 86.73% at V1, 94.04% at V2 and 92.49% at V3 and the sensitivity was 37.77% at V1, 47.62% at V2 and 13.3% at V3.ConclusionsThe prevalence of treatment adherence changes over time. Indirect methods (dose/pill count and self-reported) can be useful to detect non-adherence in COPD patients. The combination of MGT and BT is the best approach to test self-reported adherence.

Efficacy of two educational interventions about inhalation techniques in patients with chronic obstructive pulmonary disease (COPD). TECEPOC: study protocol for a partially randomized controlled trial (preference trial)

BackgroundDrugs for inhalation are the cornerstone of therapy in obstructive lung disease. We have observed that up to 75 % of patients do not perform a correct inhalation technique. The inability of patients to correctly use their inhaler device may be a direct consequence of insufficient or poor inhaler technique instruction. The objective of this study is to test the efficacy of two educational interventions to improve the inhalation techniques in patients with Chronic Obstructive Pulmonary Disease (COPD).MethodsThis study uses both a multicenter patients´ preference trial and a comprehensive cohort design with 495 COPD-diagnosed patients selected by a non-probabilistic method of sampling from seven Primary Care Centers. The participants will be divided into two groups and five arms. The two groups are: 1) the patients´ preference group with two arms and 2) the randomized group with three arms. In the preference group, the two arms correspond to the two educational interventions (Intervention A and Intervention B) designed for this study. In the randomized group the three arms comprise: intervention A, intervention B and a control arm. Intervention A is written information (a leaflet describing the correct inhalation techniques). Intervention B is written information about inhalation techniques plus training by an instructor. Every patient in each group will be visited six times during the year of the study at health care center.DiscussionOur hypothesis is that the application of two educational interventions in patients with COPD who are treated with inhaled therapy will increase the number of patients who perform a correct inhalation technique by at least 25 %. We will evaluate the effectiveness of these interventions on patient inhalation technique improvement, considering that it will be adequate and feasible within the context of clinical practice.Trial registrationCurrent Controlled Trials ISRTCTN15106246

Effectiveness of glatiramer acetate compared to other multiple sclerosis therapies.

To assess the effectiveness of glatiramer acetate (GA) compared to other multiple sclerosis (MS) therapies in routine clinical practice.

Acuerdo diagnóstico entre equipos de emergencias y servicios hospitalarios

Resumen Objetivos Desde hace 10 anos, la Empresa Publica de Emergencias Sanitarias de Andalucia estudia la concordancia de sus equipos con la atencion primaria y los hospitales. Se investiga el acuerdo diagnostico entre estos equipos y los hospitalarios, y en caso de encontrar diferencias, se valora si estas podrian estar en funcion del equipo de emergencias, el recurso de traslado o el centro hospitalario. Pacientes y metodo Estudio descriptivo. Se incluyo a 510 pacientes (seleccionados al azar) cuyos datos se conocia, atendidos por equipos 061 de Malaga en 2001 y que precisaron traslado a algun hospital publico. Se recabaron datos sobre la filiacion, la asistencia recibida, el traslado, el centro hospitalario y el diagnostico. El maximo de diagnosticos permitidos fue 3, codificados segun la clasificacion CIE-9 MC. Para la comparacion se utilizo el indice kappa. Resultados Se perdieron 10 casos. La media de diagnosticos del 061 por paciente fue de 1,48, mientras que en los informes hospitalarios fue de 1,59. Los mas frecuentes hacian referencia a traumatismos y enfermedades cardiovasculares (los inespecificos se aproximaron al 20%). El 59% de los pacientes tenia al menos un diagnostico coincidente. Para un nivel de confianza del 95% obtuvimos un indice kappa de 0,478 (proporcion de conformidad del 73,9%). Conclusiones Obtuvimos una concordancia global moderada, con mejores resultados para el Equipo de Coordinacion Avanzada y traslados en ambulancia convencional por la simplicidad de los diagnosticos. Solo llego a niveles considerados como «buenos» el Hospital Costa del Sol, con el que se comparten las guias de trabajo. El porcentaje de diagnosticos poco precisos fue alto. Las propuestas de mejora deberan ir desde la revision de los modos de trabajo hasta la aplicacion de nuevas tecnologias.

Mejora de la función pulmonar en fibrosis quística mediante insuflación-exuflación mecánica

La fibrosis quística (FQ) es una enfermedad multisistémica, de carácter progresivo, que afecta la calidad de vida del paciente. Las manifestaciones clínicas respiratorias se relacionan principalmente con su morbimortalidad, siendo la fisioterapia respiratoria (FTR) un pilar importante para la mejora del aclaramiento mucociliar1. Los dispositivos de insuflación-exuflación mecánica (IEM) generan un flujo suficientemente alto como para proporcionar un cizallamiento en las vías aéreas que desprende y moviliza las secreciones hacia el exterior. La IEM ha demostrado su eficacia en la mejora del aclaramiento de las vías respiratorias en pacientes con enfermedades neuromusculares2, y aunque existen evidencias sobre su uso en bronquiectasias sin FQ3, su aplicación en niños con FQ precisa de estudios que así la avalen1. Con el objetivo de evaluar el efecto de IEM sobre la función pulmonar en niños diagnosticados de FQ, nos planteamos un estudio prospectivo de 24 meses que compara la combinación FTR, incluida en el abordaje terapéutico habitual, más IEM (grupo tratado, n = 9) frente a la FTR (grupo control, n = 11); cumpliendo en cada caso todos los criterios de inclusión y ninguno de exclusión (tabla 1). Los procedimientos utilizados se realizaron tras obtención del consentimiento informado de los padres. La intervención se efectuó cada 21 días, durante 45 min. Se desarrollaron 3 ciclos de 6-8 respiraciones por decúbito (tiempo de insuflación 5 s, tiempo de exhalación 5 s, tiempo de pausa 2 s; presiones utilizadas +30/−35 cmH2O; aparato CoughAssist®, Philips). Para mejorar la eliminación de la obstrucción bronquial se aplicaron presiones abdominales. Antes y después de cada sesión se monitorizó la pulsioximetría. Para la valoración de la función pulmonar se llevó a cabo espirometría basal forzada según normativa SEPAR a los 6, 12, 18 y 24 meses tras el inicio de la intervención, considerándose mejora el incremento de al menos un 5% en FVC (%) y FEV1 (%); y deterioro, una reducción ≥ 5% (tabla 1). De los 9 pacientes tratados, se excluyeron 2, por miedo al dispositivo y por no asistencia, respectivamente. Aun partiendo de una función pulmonar más deteriorada que el grupo control, 60

Efficacy of the Treatments Used in Multiple Sclerosis: From Meta-analysis to Number Needed to Treat.

The aim of this study was to analyze the efficacy of drugs used in relapsing-remitting multiple sclerosis, first- and second-line drugs, using the number needed to treat (NNT) as a measure of efficacy. Methods Data from randomized clinical trials were analyzed for 3 categories of clinical efficacy outcomes: relapse, change in Expanded Disability Status Scale, and number of new lesions in magnetic resonance imaging. Meta-analysis results are expressed as odds ratios. Results The global odds ratio was 0.41 (95% confidence interval [CI], 0.34–0.49). For analyzed clinical outcomes, the odds ratio was less for second-line drugs (odds ratio, 2.0). For all studied clinical conditions, in the control group, 47 of 100 patients do not get benefits, compared with 25 (95% CI, 18–32 patients) of 100 for the active treatment group. The NNT was 5 patients (95% CI, 4–7 patients). For the proportion of patients free of relapses, in the control group, 56 of 100 patients had a relapse at 2 years, compared with 37 of 100 patients in the treatment group, with an NNT of 6 patients (95% CI, 5–8 patients). Conclusions Active treatments produced statistically significant improvements compared with placebo.