Epidemiologia Clinica Alvaro Rui
Bartolome Moosavi
Methods: To study the relationship between health-related quality of life and morbidity and survival, we carried out an inception cohort study in patients starting chronic dialysis, mostly diabetics, with a follow-up of 1-3 years in 34 Spanish hospitals. Health-related quality of life was measured by the SF-36 Health Survey and Karnofsky scale. Charlson age-comorbidity index and other prognostic clinical variables were measured concurrently. The primary outcome variable was time until death and the secondary outcome was hospitalization days.
Results: Clozapine, olanzapine, risperidone, ziprasidone, amisulpride, paliperidone, haloperidol, quetiapine, and aripiprazole were more effective than placebo for the majority of psychotic symptoms and the abandonment of treatment, but asenapine was not. Paliperidone, risperidone, quetiapine, clozapine, and olanzapine showed significant increases in weight compared to placebo. Haloperidol, risperidone, ziprasidone, and paliperidone had a higher risk of extrapyramidal symptoms than placebo. There was a significant risk of sedation or drowsiness with, risperidone, haloperidol, ziprasidone, quetiapine, olanzapine, and clozapine in the comparisons with placebo. Of the results of the comparisons between AP, it was shown that clozapine and paliperidone had a clinically significant effect compared to haloperidol and quetiapine, respectively. Olanzapine and risperidone had a lower risk of abandoning the treatment in general, and due to adverse reactions in two comparisons of each one, haloperidol was the drug with more risk of abandoning due to adverse effects, followed by clozapine. Amisulpride, haloperidol and ziprasidone had favourable results as regards weight increase in several comparisons. Aripiprazole and paliperidone obtained a higher number of favourable results as regards sedation, and all the atypical drugs (except paliperidone) had a lower risk than the use of anti-parkinsonian drugs. Of the evidence from observational studies, it was found that, in subjects with risk factors for diabetes, such as age, hypertension, and dyslipidaemia, the initial treatment and current treatment with olanzapine, as well as current treatment with clozapine, may promote the development of this disease.
Conclusion: Although it is imperative to prescribe an antipsychotic for treatment of the acute phase, the selection of the drug depends on the particular clinical condition of each patient and their collateral effects profile.
However, it is important to point out some features of the model of the studies which generate the evidences to allow the development of "MABBEE medicine". The randomized double-blind control trial with an adequate sample size and quality control is the ideal design to compare placebo to any treatment, or different types of clinical or surgical treatments. Although this seems obvious, it has still not been widely applied to medical practice in this country. Reasoning based on experience, case reports, and retrospective studies are still very common in Medical Journals and meetings.
Another method of obtaining good evidence is the systematic review of medical treatments followed by a statistical summary named meta-analysis. This type of research should include all the published and unpublished controlled clinical trials with good standards. The typical odds ratio - the final result - usually represents the best evidence regarding that specific treatment until the moment the meta-analysis was properly completed. However the consistency of the results depends on the clinical trials found in the literature. Publication bias, which is the tendency by some journal editors not to publish clinical trials with negative results, affects not only the authors submitting the papers but also the systematic review preparation, and finally the doctors interested in the best evidence-based medicine, which, as a consequence, affects the patients.
In other words, good clinical research depends on the use of clinical epidemiology and the adherence to very well-designed studies, which take into account the prevention of bias and the application of appropriate statistical methods.
6. Was there good quality control of, for example when analyzing clinical trial: frequency of drop-outs, adherence to the treatment and to the randomization process, co-intervention, and contamination prevention?
So, in order to practice MABBEE Medicine, or Evidence-Based Medicine, all doctors and not only Medical Journal editors will need to be familiar with the essentials of clinical epidemiology in the future.
MASK-air, a validated mHealth app (Medical Device regulation Class IIa) has enabled large observational implementation studies in over 58,000 people with allergic rhinitis and/or asthma. It can help to address unmet patient needs in rhinitis and asthma care. MASK-air is a Good Practice of DG Santé on digitally-enabled, patient-centred care. It is also a candidate Good Practice of OECD (Organisation for Economic Co-operation and Development). MASK-air data has enabled novel phenotype discovery and characterisation, as well as novel insights into the management of allergic rhinitis. MASK-air data show that most rhinitis patients (i) are not adherent and do not follow guidelines, (ii) use as-needed treatment, (iii) do not take medication when they are well, (iv) increase their treatment based on symptoms and (v) do not use the recommended treatment. The data also show that control (symptoms, work productivity, educational performance) is not always improved by medications. A combined symptom-medication score (ARIA-EAACI-CSMS) has been validated for clinical practice and trials. The implications of the novel MASK-air results should lead to change management in rhinitis and asthma.
N2 - MASK-air, a validated mHealth app (Medical Device regulation Class IIa) has enabled large observational implementation studies in over 58,000 people with allergic rhinitis and/or asthma. It can help to address unmet patient needs in rhinitis and asthma care. MASK-air is a Good Practice of DG Santé on digitally-enabled, patient-centred care. It is also a candidate Good Practice of OECD (Organisation for Economic Co-operation and Development). MASK-air data has enabled novel phenotype discovery and characterisation, as well as novel insights into the management of allergic rhinitis. MASK-air data show that most rhinitis patients (i) are not adherent and do not follow guidelines, (ii) use as-needed treatment, (iii) do not take medication when they are well, (iv) increase their treatment based on symptoms and (v) do not use the recommended treatment. The data also show that control (symptoms, work productivity, educational performance) is not always improved by medications. A combined symptom-medication score (ARIA-EAACI-CSMS) has been validated for clinical practice and trials. The implications of the novel MASK-air results should lead to change management in rhinitis and asthma.
AB - MASK-air, a validated mHealth app (Medical Device regulation Class IIa) has enabled large observational implementation studies in over 58,000 people with allergic rhinitis and/or asthma. It can help to address unmet patient needs in rhinitis and asthma care. MASK-air is a Good Practice of DG Santé on digitally-enabled, patient-centred care. It is also a candidate Good Practice of OECD (Organisation for Economic Co-operation and Development). MASK-air data has enabled novel phenotype discovery and characterisation, as well as novel insights into the management of allergic rhinitis. MASK-air data show that most rhinitis patients (i) are not adherent and do not follow guidelines, (ii) use as-needed treatment, (iii) do not take medication when they are well, (iv) increase their treatment based on symptoms and (v) do not use the recommended treatment. The data also show that control (symptoms, work productivity, educational performance) is not always improved by medications. A combined symptom-medication score (ARIA-EAACI-CSMS) has been validated for clinical practice and trials. The implications of the novel MASK-air results should lead to change management in rhinitis and asthma.
Experience in planning and conducting large longitudinal studies, especially from the 1950s onwards, has enabled the development of QAC tools to be used in cohort studies8 and in randomized clinical trials.4 The QAC system of Elsa-Brasil was based on this international experience, and necessary adaptations were performed by the Steering Committee and its Advisory Committees, founded on principles outlined by the QAC Committee.
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