Follow up of patients who start treatment with antidepressants: treatment satisfaction, treatment compliance, efficacy and safety

BMC Psychiatry

Study Protocol

Alejandro Villena¹  José M Del Campo²  Ignacio Párraga³  Jesús López-Torres³ 

[1] Albacete Area VB Health Centre, Health Care Service of Castilla-La Mancha, C/Macedonio Jiménez, s/n, 02006, Albacete, Spain;Almansa Health Centre, Health Care Service of Castilla-La Mancha, C/San Juan s/n, 02640, Almansa, Albacete, Spain;Research Unit, Primary Care Head Office of Albacete, Health Care Service of Castilla-La Mancha, Marqués de Villores 6-8, 02001, Albacete, Spain;

关键词: Depressive Symptom;    Antidepressant Drug;    Antidepressant Treatment;    Treatment Satisfaction;    Hamilton Depression Rate Scale;   

DOI  :  10.1186/1471-244X-13-65

 received in 2012-08-01, accepted in 2013-02-13,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundMeasuring satisfaction with treatment has proved useful to ascertain the treatment features that are most important to the patients, and to explain increased treatment compliance. However, there are few studies that relate satisfaction to other clinical or self-perceived health status indicators. Recent studies have shown the close relationship between satisfaction with treatment, treatment compliance, and effectiveness. This study attempts to design and validate a scale to evaluate satisfaction with antidepressant drug therapy, assess treatment compliance (self-reported, validated questionnaire, drug accountability and electronic monitorization system), assess efficacy in reducing depressive symptoms and safety in patients who initiate antidepressant drug therapy, as well as to establish predictors of satisfaction, compliance and effectiveness with these drugs.Methods/designThis is an observational longitudinal study with a cohort of adults initiating treatment with antidepressant drugs. A multi-centre study will be performed in which 20 Primary Care practices from Castilla-La Mancha are expected to participate. An initial interview and follow-up visits at 15 days, 1, 3, 6, 9 and 12 months will be conducted with all study participants. 706 subjects will be studied (95% confidence interval, precision ± 3%, expected rate of non-compliance 50%, expected non-responders and lost to follow up rate 15%). The following measurements will be performed: development and validation of a scale of satisfaction with antidepressant therapy, participant and antidepressant characteristics, treatment compliance evaluation (Haynes-Sackett Test, Morisky-Green Test, drug accountability and Medication Event Monitoring System), depression symptom reduction (Hamilton Depression Rating Scale and Montgomery-Asberg Depression Rating Scale), observation of adverse effects, and beliefs about treatment (The Beliefs about Medicines Questionnaire).DiscussionAntidepressant drugs are an extraordinarily important therapeutic group in the pharmacy composition; economic repercussions and social impact associated to their use is clear. Despite their well-established efficacy in clinical trials, treatment non-compliance is a major obstacle to their effectiveness in clinical practice. The proposed study brings about useful conclusions to improve the results of these drugs. Additionally, devising a scale specifically designed to evaluate satisfaction with antidepressant treatment could be of interest in healthcare outcomes research.

【 授权许可】

CC BY   
© López-Torres et al.; licensee BioMed Central Ltd. 2013