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Validation of a simplified medication adherence questionnaire in a large cohort of HIV-infected patients: the GEEMA Study

Knobel, Hernandoa; Alonso, Jordib; Casado, José L.c; Collazos, Juliod; González, Juane; Ruiz, Isabelf; Kindelan, José M.g; Carmona, Alexiah; Juega, Javieri; Ocampo, Antonio*; on behalf of the GEEMA Study Group

Clinical

Objective: To assess the effectiveness of the simplified medication adherence questionnaire (SMAQ) in identifying non-adherent patients.

Design: Prospective observational study of adherence. The six-item SMAQ was developed. The following aspects were evaluated: (i) criterion validity, comparison with electronic adherence monitoring; (ii) construct validity, association between adherence, as defined by the SMAQ, and virological outcomes; and (iii) reliability, internal consistency and reproducibility.

Patients: A group of 3004 unselected HIV patients who had initiated nelfinavir therapy combined with other antiretroviral drugs [21% naive, 15% protease inhibitor (PI)-naive, 64% PI-experienced] between January 1998 and December 1999 were enrolled in 69 hospitals in Spain. The SMAQ was administered at months 3, 6 and 12.

Results: The SMAQ showed 72% sensitivity, 91% specificity and a likelihood ratio of 7.94 to identified non-adherent patients, compared with the medication-event monitoring system (40 patients evaluated). At month 12, 1797 patients were evaluated, of whom 32.3% were defined as non-adherent; viral load < 500 copies/ml found in 68.3% of the adherent, and 46% of the non-adherent patients. A logistic regression analysis of PI-naive patients was performed, including age, sex, baseline viral load > 5 log10/ml, CD4 cell count < 200 × 106/l, and non-adherence as independent variables. Non-adherence was the only significant risk factor in failing to achieve virological suppression. Cronbach's alpha internal consistency coefficient was 0.75, and overall inter-observer agreement was 88.2%.

Conclusion: The SMAQ appears to be an adequate instrument with which to assess adherence in HIV-infected patients, and may be applied in most clinical settings.

From the aDepartment of Internal Medicine – Infectious Diseases, Hospital del Mar, Barcelona, Spain; bHealth Services Research Unit, Institut Municipal de Investigación Médica, Barcelona, Spain; cDepartment of Infectious Diseases, Hospital Ramón y Cajal, Madrid, Spain; dDepartment of Infectious Diseases, Hospital Galdakao, Vizcaya, Spain; eDepartment of Infectious Diseases, Hospital La Paz, Madrid, Spain; fDepartment of Infectious Diseases, Hospital Valle Hebrón, Barcelona, Spain; gDepartment of Infectious Diseases, Hospital Reina Sofía, Córdoba, Spain; hDepartment of Pharmacy, Hospital del Mar, Barcelona, Spain; iDepartment of Infectious Diseases Hospital Juan Canalejo, La Coruña, Spain; and jDepartment of Internal Medicine, Hospital Xeral Cies, Vigo, Spain.

*For members of the GEEMA Study Group see Appendix.

Correspondence to: Hernando Knobel, Department of Internal Medicine – Infectious Diseases, Hospital del Mar, Paseo Marítimo 25–29, 08003 Barcelona, Spain. Tel: +34 93 2483251; fax: +34 93 2483257; e-mail: hknobel@imas.imim.es

Received: 27 July 2001;

revised: 9 November 2001; accepted: 13 November 2001.

Sponsorship: This study was partly funded by an unrestricted grant from Roche Laboratories, Spain.

© 2002 Lippincott Williams & Wilkins, Inc.