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In the primary care PC setting in Spain, the prevalence of emotional disorders EDs such as anxiety, depression and somatoform disorder is high. In PC patients, these disorders are not always managed in accordance with the recommendations provided by clinical practice guidelines, resulting in major direct and indirect economic costs and suboptimal treatment outcomes. The aim is to analyze and compare the cost-effectiveness and cost-utility of group-based psychological therapy versus treatment as usual TAU.
Multicenter, randomized controlled trial involving patients recruited from PC centers in Madrid, Spain, with symptoms or possible diagnosis of anxiety, mood mild or moderateor somatoform disorders.
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Patients will be randomized to one of two groups: Direct and indirect costs will be calculated and relevant socio-demographic variables will be registered.
Patients will be assessed at baseline, immediately after treatment finalization, and at 6 and 12 months post-treatment. This is the first comparative economic evaluation of these two treatment approaches in PC.
Emotional disorders EDs —especially anxiety, mood, and somatoform disorders—are the most prevalent types of mental disorders in Spain Haro et al. According to a recent study in Spain Serrano-Blanco et al. Medical treatment usually involves the prescription of psychoactive drugs, most commonly dreivaciones. However, according to clinical practice guidelines, medical therapy is not the treatment of merdano rather, for most EDs, the initial treatment recommendation is psychological therapy.
Given this tendency in the Spanish system to prescribe medications, it derkvaciones not surprising that anxiolytic use in Spain is much higher than in other countries. The high use of psychoactive drugs in Spain reflects not only the prevalence of EDs, but also underscores the burden of these illnesses. According to Lara et al.
The total economic cost for mental disorders in Spain is high, but precise figures are not known because published estimates vary widely. Despite the high deeivaciones of both anxiety and depressive disorders in Spain, one study found that medgano The reason s for this lack of adherence to evidence-based clinical practice guidelines is unclear.
Consequently, more research is needed to investigate this question so that steps can be taken to improve physician adherence to guidelines and, thereby, improve treatment effectiveness and reduce treatment-related costs, particularly those associated with prescription medications.
Poor adherence to clinical guidelines is not unique to Spain. That initiative has been very successful, resulting in substantially improved treatment outcomes while simultaneously reducing costs particularly due to decreased drug prescriptions compared to the usual PC treatment Radhakrishnan et al. Indeed, given the success of the IAPT program with EDs, the program has been extended for use in children and in patients with chronic physical conditions Gyani et al.
Due to the considerable savings of the CBT approach versus drug-based therapies, one recent study estimated that even if the number of patients treated with CBT in the PC setting doubled fromto 1 million per yearthe net cost would likely be zero if patients with common mental disorders anxiety and depression and those with comorbid chronic physical conditions receive CBT Layard and Clark, Given this context, the present work describes the design of a study being conducted as part of the PsicAP clinical trial sub-study 2.
The aim of this sub-study is to assess and compare the costs associated with psychological and pharmacological treatment approaches for mental disorders in the PC setting in Spain.
This study will assess the relationship between cost-effectiveness and cost-utility of these two different treatment approaches. We hypothesize that the costs of switching from TAU to a group-based TD-CBT approach will be justified by the expected additional clinical and social benefits a superiority trial.
Patients will be randomly allocated to one of two groups—an experimental group and a control group—both of which will be treated in a PC setting. The experimental group will receive group-based CBT and the control group will receive TAU mainly pharmacological interventions. Evaluators will be blinded to the treatment group allocation throughout the evaluation period. Patients from the participating PC centers will be recruited by their GP who will provide patients with a document containing detailed information about the study.
All patients will be required to sign an informed consent form prior to enrolment.
The study inclusion criteria for the first phase of recruitment, which will be managed by the GP, are as follows: In the second phase of recruitment, clinical psychologists will consider the following kedrano criteria: All candidates will be assessed with the PHQ Spitzer et al. The Spanish version validated by Diez-Quevedo et al. Exclusion criteria include the following: Additional exclusion criteria include: Participants who score between 20 and 23 points on the PHQ will undergo a second order assessment conducted by a clinical psychologist to confirm the existence of severe major depression, and any patients with major depression will also be excluded from the trial.
Patients will not receive any financial compensation for their participation in the study. Two programs were used to determine sample size: However, it should be noted that previous investigations have proven that participants are sufficient for dee cost-effectiveness study Rubio-Valera et dee.
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After informed consent is obtained, participants are randomly assigned to either the treatment or control group by a researcher, according to a blind research design, using a computer-generated allocation sequence, thus assuring comparable groups on main cerivaciones. Subjects will receive the allocation information via email from a graduate student trainee affiliated with the project. The email will also provide login details and website information for the allocated intervention.
One clinical psychologist will be assigned to the TD-CBT group; importantly, the clinical psychologist involved in the pre- and post-treatment assessment phases will not participate in the TD-CBT therapy. Data managers and statisticians will also be blinded to the treatment allocation.
Derivaclones treatment program is included within a collaborative protocol of a stepped-care model of treatment, as recommended by the NICE guidelines. The characteristics of this treatment have been described previously by Cano-Vindel EDs are believed to originate from a dual process of dysfunctional emotional learning over time that involves both cognitive increasing use of cognitive distortions and associative classical conditioning in some significant emotional events learning.
Although this dysfunctional learning tends to lead to symptom chronicity and the development of new, comorbid disorders, the process is considered to be reversible. Moreover, both types of functional relearning i.
A transdiagnostic approach Newby et al.
However, the derivaclones characteristics of the cases in each group will be taken into consideration. Patients in the experimental group will be divided into subgroups of medrno eight patients each and will derivacionds treated by clinical psychologists specifically trained for this program. The intervention will include seven sessions 1. The contents include the following: All patients in the control group will receive standard treatment TAU from their GP according to the usual criteria.
In most cases, this will involve pharmacological treatment. This system contains a number of self-report instruments that can detect the presence of depressive, anxiety, and somatoform disorders Kroenke et al. The PHQ-9 Kroenke et al. Only symptoms occurring during the 2 weeks prior to the evaluation are considered. Items are rated on a four-point Likert scale from 0 to 3, as follows: For a diagnosis of MDD, the algorithm requires a score of 2 or 3 on at least one of the first medrwno symptoms, and must score 2 or 3 on at least 5 of the 9 items the 9th item-suicide attempts-also counts with a score of 1.
Another item item 10 has been added to evaluate the degree of dysfunction McMillan et al. The GAD-7 Spitzer et al.
This instrument can be used not only as a screening test for GAD, but also for other anxiety disorders. The maximum score is The PHQ includes 13 somatic symptoms, with a maximum score of To detect a probable diagnosis of somatization disorder, at least 3 of the first 13 symptoms must receive the maximum score two pointsand there can be no biological explanation for the somatic disorder.
A more recent version—the PHQ Kroenke et al. Two additional items also assess the degree of medraho in deriavciones last week and the perceived level of social support. The first four items are scored on a point scale ranging from 0 unimpaired to 10 maximum disability.
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Scores ranging from 1—3, 4—6, and 7—9 indicate, respectively, mild, moderate, or high disability. In this study, our aim was to compare the association between cost-effectiveness and cost-utility of the two treatments.
The economic evaluation will be conducted by recording variables see below obtained from patient medical records and patient interviews.
To quantify direct costs, the following variables only related to EDs will be registered and assessed: Indirect costs will include all days off from work. If a replacement worker is needed, then this will be registered as an indirect cost as well.
All the variables will be collected for the following time points: After providing written informed consent, the participants will be registered in the treating center. Pre- and post-treatment assessments are to be carried out using computerized self-reported screening tests.
All pretreatment assessments will be performed at the treating PC center after scheduling an appointment with the clinical psychologist. A computer with Internet access is used to collect data. All data are stored on a general virtual website surveymonkey. At all post-treatment follow-up assessments, the same instruments will be completed in person at the treating center.
If necessary, we will send the participant a link by email to enable the patient to complete the computerized measures at home. Patients are contacted by phone to encourage completion of the questionnaires. Patients who discontinue or drop out of treatment will still be invited to complete the post-treatment follow-up assessments, particularly the first post-treatment assessment.
The main outcomes are the clinical symptoms assessed by the PHQ: Measures of disability will be included in the secondary outcomes. The following socio-demographic variables will be registered and analyzed: This study will be conducted on an intention-to-treat basis. Both groups will be compared to verify that there are no significant between-group differences at baseline. For comparisons, the ANOVA method will be used for continuous variables and the Chi-square test for categorical variables.
Subsequently, a repeated measurement of ANOVA, including all variables over time, will be performed to assess whether missing values respond to a random or non-random pattern.
Direct costs of health care will be estimated by adding the costs derived from medication use antidepressants, hypnotics, sedatives, and anxiolyticsmedical tests, use of health-related services, and staffing costs. The cost of medications will be calculated by determining the price per milligram mg during the study period according to the Vademecum International Vidal,including value-added tax.
Total costs of medications will be calculated by multiplying the price per mg by the daily dose mg and the number of days of drug treatment.