Cost-effectiveness of active monitoring versus antidepressants for major depression in primary health care: a 12-month non-randomized controlled trial (INFAP study)

BMC Psychiatry

Antoni Serrano-Blanco⁶  Javier García-Campayo⁴  Katarzyna Kocyan¹  Ramon Sabés-Figuera^1,10  Martin Knapp²  Paul McCrone⁸  Juan M Mendive⁵  Juan V Luciano³  María Teresa Peñarrubia-María⁹  Imma Beneitez³  Maria Rubio-Valera⁷ 

[1] Fundació Sant Joan de Déu, Esplugues de Llobregat, Spain;Personal Social Services Research Unit, London School of Economics and Political Science, Houghton Street, London, UK;Open University of Catalonia (UOC), Barcelona, Spain;Miguel Servet Hospital, University of Zaragoza, Instituto Aragones de Ciencias de la Salud, Zaragoza, Spain;La Mina Primary Care Centre, Institut Català de la Salut, Sant Adrià de Besós, Barcelona, Spain;Primary Care Prevention and Health Promotion Research Network (RedIAPP), Barcelona, Spain;School of Pharmacy, Universitat de Barcelona, Barcelona, Spain;Institute of Psychiatry, King’s College London, De Crespigny Park, London, UK;Primary Care Health Centre Bartomeu Fabrés Anglada, Servei d’Atenció Primària Delta Llobregat, Àmbit Costa de Ponent, Institut Català de la Salut, Gavà, Spain;Institute for Prospective Technological Studies/Joint Research Centre, European Commission, Sevilla, Spain

关键词: Primary Health Care;    Costs and Cost Analysis;    Watchful Waiting;    Active Monitoring;    Antidepressive Agents;    Depressive Disorder;   

Others  :  1164377
DOI  :  10.1186/s12888-015-0448-3

 received in 2014-11-12, accepted in 2015-03-18,  发布年份 2015

【 摘 要 】

Background

Clinical practice guidelines for the treatment of major depressive disorder (MDD) recommend antidepressants for patients with moderate-severe depression and active monitoring for patients with mild-moderate symptoms. The feasibility and efficiency of active monitoring has not been proven conclusively. The aim of this study is to evaluate the cost-effectiveness of active monitoring in comparison to antidepressants for primary care patients with mild-moderate MDD.

Methods/Design

This is a 12-month follow-up multicenter observational prospective controlled trial. Patients are enrolled in 12 primary care centers in Barcelona (Spain). Eligible patients are adults (≥18 years-old) with a new episode of MDD that sign a written consent to participate. This is a naturalistic study in which general practitioners (GPs) use their professional judgment to allocate patients into active monitoring or antidepressants groups. GPs treat the patients following their clinical criteria. At baseline, GPs complete a questionnaire (sociodemographic/job characteristics, training, attitude towards depression, interest on mental health and participation in communication groups). Patients’ measurements take place at baseline and after six and 12 months. Main outcome measures include severity of depression (PHQ-9), health-related quality of life (EuroQol-5D) and use of healthcare and social care services (Client Service Receipt Inventory). Secondary outcomes include diagnosis of MDD according to DSM-IV diagnostic criteria (SCID-I), disability (WHO-DAS), anxiety (BAI), comorbidities, medication side-effects and beliefs about medicines (BMQ).

The analysis will be done according to the intention to treat analysis. Missing data will be imputed using multiple imputation by chained equations. To minimize the bias resulting from the lack of randomization, a propensity score will be used. Incremental effects and costs between groups will be modelled in each of the imputed databases using multivariate generalized linear models and then combined as per Rubin’s rules. Propensity scores will be used to adjust the models. Incremental cost-effectiveness ratios will be calculated by dividing the difference in costs between groups by the difference in effects. To deal with the uncertainty, resampling techniques with bootstrapping will be used and cost-effectiveness planes and cost-effectiveness acceptability curves will be constructed. A series of sensitivity analyses will be performed.

Discussion

Given the high burden and costs generated by depressive disorder, it is important that general practitioners treat major depression efficiently. Recent evidence has suggested that antidepressants have low benefits for patients with mild to moderate major depression. For such cases of depression, active monitoring exists as a treatment option, but it is not without difficulties for implementation and its effectiveness and efficiency have not been demonstrated conclusively. The results of the study will provide information on which is the most efficient approach to treat patients with mild to moderate major depression in primary care.

Trial registration

ClinicalTrials.gov: NCT02245373

【 授权许可】

   
2015 Rubio-Valera et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Salvador-Carulla L, Bendeck M, Fernández A, Alberti C, Sabes-Figuera R, Molina C, et al.: Costs of depression in Catalonia (Spain). J Affect Disord 2011, 132:130-8.
• [2]Demyttenaere K, Bruffaerts R, Posada-Villa J, Gasquet I, Kovess V, Lepine JP, et al.: Prevalence, severity, and unmet need for treatment of mental disorders in the World Health Organization World Mental Health Surveys. JAMA 2004, 291:2581-90.
• [3]Ustün TB, Ayuso-Mateos JL, Chatterji S, Mathers C, Murray CJL: Global burden of depressive disorders in the year 2000. Br J Psychiatry 2004, 184:386-92.
• [4]Golberg D, Huxley P: Common Mental Disorders: a Biosocial Model. Tavistock/Routledge, London; 1992.
• [5]Serrano-Blanco A, Palao DJ, Luciano JV, Pinto-Meza A, Luján L, Fernández A, et al.: Prevalence of mental disorders in primary care: Results from the diagnosis and treatment of mental disorders in primary care study (DASMAP). Soc Psychiatry Psychiatr Epidemiol 2010, 45:201-10.
• [6]King M, Nazareth I, Levy G, Walker C, Morris R, Weich S, et al.: Prevalence of common mental disorders in general practice attendees across Europe. Br J Psychiatry 2008, 192:362-7.
• [7]Rubio-valera M, Fernández A, Luciano JV, Hughes CM, Pinto-meza A, Moreno-küstner B, et al.: Psychotropic prescribing in catalonia: Results from an epidemiological study. Fam Pract 2012, 29:154-62.
• [8]Fernández A, Rubio-Valera M, Bellón JA, Pinto-Meza A, Luciano JV, Mendive JM, et al.: Recognition of anxiety disorders by the general practitioner: results from the DASMAP study. Gen Hosp Psychiatry 2012, 34:227-33.
• [9]Fernández A, Pinto-Meza A, Bellón JA, Roura-Poch P, Haro JM, Autonell J, et al.: Is major depression adequately diagnosed and treated by general practitioners? Results from an epidemiological study. Gen Hosp Psychiatry 2010, 32:201-9.
• [10]Fournier JC, DeRubeis RJ, Hollon SD, Dimidjian S, Amsterdam JD, Shelton RC, et al.: Antidepressant drug effects and depression severity: a patient-level meta-analysis. JAMA 2010, 303:47-53.
• [11]Cape J, Whittington C, Buszewicz M, Wallace P, Underwood L: Brief psychological therapies for anxiety and depression in primary care: meta-analysis and meta-regression. BMC Med 2010, 8:38. BioMed Central Full Text
• [12]National Institute for Clinical Excellence.Depression: Management of Depression in Primary and Secondary Care; 2009.
• [13]Agència d’Informació A i Q en SP director de salut mental i addiccions. D de SG de C: Guía de Pràctica Clínica catalana: Adaptació al model sanitari català de la guia de pràctica clínica sobre el maneig de la depressió major en l’adult. 2010.
• [14]Hegel MT, Oxman TE, Hull JG, Swain K, Swick H: Watchful waiting for minor depression in primary care: remission rates and predictors of improvement. Gen Hosp Psychiatry 2006, 28:205-12.
• [15]Bosmans JE, Hermens MLM, de Bruijne MC, van Hout HPJ, Terluin B, Bouter LM, et al.: Cost-effectiveness of usual general practitioner care with or without antidepressant medication for patients with minor or mild-major depression. J Affect Disord 2008, 111:106-12.
• [16]Williams JW, Barrett J, Oxman T, Frank E, Katon W, Sullivan M, et al.: Treatment of Dysthymia and Minor Depression in Primary Care: A Randomized Controlled Trial in Older Adults. 2000.
• [17]Kendrick T, Chatwin J, Dowrick C, Tylee A, Morriss R, Peveler R, et al.: Randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of selective serotonin reuptake inhibitors plus supportive care, versus supportive care alone, for mild to moderate depression with somatic symptoms in primary care. Health Technol Assess 2009, 13(iii–iv, ix–xi):1-159.
• [18]Meredith LS, Cheng WJY, Hickey SC, Dwight-Johnson M: Factors associated with primary care clinicians’ choice of a watchful waiting approach to managing depression. Psychiatr Serv 2007, 58:72-8.
• [19]Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al.: SPIRIT 2013 statement: Defining standard protocol items for clinical trials. Ann Intern Med 2013, 2013:200-7.
• [20]Mira JJ, Llinás G, Gil V, Orozco D, Palazón I, Vitaller J: Validation of an instrument for identifying styles of the professional practice of the primary care doctor. Aten Primaria 1998, 21:14-22.
• [21]Morisky DE, Green LW, Levine DM: Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care 1986, 24:67-74.
• [22]Chisholm D, Knapp MRJ, Knudsen HC, Amaddeo A, Gaite L, Van Wijngaarden B. Client socio-demographic and service receipt inventory - European version: Development of an instrument for international research. EPSILON study 5. Br J Psychiatry. 2000;177:s28-33.
• [23]Spanish National Institute of Statistics: Minimum wage survey; 2015.
• [24]Spitzer RL: Kroenke K, Williams JB: Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA 1999, 282:1737-44.
• [25]Diez-Quevedo C, Rangil T, Sanchez-Planell L, Kroenke K, Spitzer RL. Validation and utility of the patient health questionnaire in diagnosing mental disorders in 1003 general hospital Spanish inpatients. Psychosom Med. 2001;63:679–86.
• [26]Kroenke K, Spitzer RL, Williams JBW: The PHQ-9: Validity of a brief depression severity measure. J Gen Intern Med 2001, 16:606-13.
• [27]Group TE: a new facility for the measurement of health-related quality of life. Heal Policy 1990, 16:199-208.
• [28]Badia X, Schiaffino A, Alonso J, Herdman M: Using the EuroQol 5-D in the Catalan general population: Feasibility and construct validity. Qual Life Res 1998, 7:311-22.
• [29]Badia X, Roset M, Montserrat S, Herdman M, Segura A: [The Spanish version of EuroQol: a description and its applications. European Quality of Life scale]. Med Clin (Barc) 1999, 112:79-85.
• [30]Dolan P, Gudex C, Kind P, Williams A. A social tariff for EuroQol: results from a UK general population survey. York: Centre for Health Economics, University of York; 1995.
• [31]First MB et, Spitzer RL, Gibbon M, Williams JBW. Structured Clinical Interview for DSM-IV Axis I Disorders, Clinician Version (SCID-CV). 1997:132.
• [32]Luciano JV, Ayuso-Mateos JL, Fernandez A, Aguado J, Serrano-Blanco A, Roca M, et al.: Utility of the twelve-item World Health Organization disability assessment schedule II (WHO-DAS II) for discriminating depression “caseness” and severity in Spanish primary care patients. Qual Life Res 2010, 19:97-101.
• [33]Luciano JV, Ayuso-Mateos JL, Fernández A, Serrano-Blanco A, Roca M, Haro JM: Psychometric properties of the twelve item World Health Organization Disability Assessment Schedule II (WHO-DAS II) in Spanish primary care patients with a first major depressive episode. J Affect Disord 2010, 121:52-8.
• [34]Luciano JV, Ayuso-Mateos JL, Aguado J, Fernandez A, Serrano-Blanco A, Roca M, et al.: The 12-item World Health Organization Disability Assessment Schedule II (WHO-DAS II): a nonparametric item response analysis. BMC Med Res Methodol 2010, 10:45. BioMed Central Full Text
• [35]Sanz Fernández J, Navarro ME. Propiedades psicométricas de una versión española del Inventario de Ansiedad de Beck (BAI) en estudiantes universitarios. Ansiedad y estrés. 2003;9:59–84.
• [36]Beck AT, Epstein N, Brown G, Steer RA: An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol 1988, 56:893-7.
• [37]Horne R, Weinman J, Hankins M: The beliefs about medicines questionnaire: The development and evaluation of a new method for assessing the cognitive representation of medication. Psychol Health 1999, 14:1-24.
• [38]Beléndez Vázquez M, Hernández Mijares A, Horne R, Weinman J: Evaluación de las creencias sobre el tratamiento: validez y fiabilidad de la versión española del Beliefs about Medicines Questionnaire. 2007.
• [39]Sterne JAC, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, et al.: Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. Br Med J 2009, 338(July):b2393.
• [40]White IR, Royston P, Wood AM: Multiple imputation using chained equations: Issues and guidance for practice. Stat Med 2011, 30:377-99.
• [41]Rubio-Valera M, Bosmans J, Fernández A, Peñarrubia-María M, March M, Travé P, et al.: Cost-effectiveness of a community pharmacist intervention in patients with depression: a randomized controlled trial (PRODEFAR Study). PLoS One 2013, 8:e70588.
• [42]Al MJ, van Hout BA, Michel BC, Rutten FF: Sample size calculation in economic evaluations. Health Econ 1998, 7:327-35.
• [43]Serrano-Blanco A, Pinto-Meza A, Suárez D, Peñarrubia MT, Haro JM: Cost-utility of selective serotonin reuptake inhibitors for depression in primary care in Catalonia. Acta Psychiatr Scand Suppl 2006, 114:39-47.
• [44]Rubio-Valera M, March Pujol M, Fernández A, Peñarrubia-María MT, Travé P, López del Hoyo Y, et al.: Evaluation of a pharmacist intervention on patients initiating pharmacological treatment for depression: A randomized controlled superiority trial. Eur Neuropsychopharmacol 2013, 23:1057-66.
• [45]Serna MC, Cruz I, Real J, Gascó E, Galván L: Duration and adherence of antidepressant treatment (2003 to 2007) based on prescription database. Eur Psychiatry 2010, 25:206-13.