Longitudinal Assessment of Quality of Life in Patients With Type 2 Diabetes and Self- Reported Erectile Dysfunction GIORGIA DE BERARDIS, MSCPHARMCHEM FABIO PELLEGRINI, MSCSTAT MONICA FRANCIOSI, MSCBIOLS MAURIZIO BELFIGLIO, MD BARBARA DI NARDO, HSDIP SHELDON GREENFIELD, MD SHERRIE H. KAPLAN, PHD, MPH MARIA C.E. ROSSI, MSCPHARMCHEM MICHELE SACCO, MD GIANNI TOGNONI, MD MIRIAM VALENTINI, MD ANTONIO NICOLUCCI, MD ON BEHALF OF THE QUED (QUALITY OF CARE AND OUTCOMES IN TYPE 2 DIABETES)STUDY GROUP* OBJECTIVE — In the context of the QuED (Quality of Care and Outcomes in Type 2 Dia- betes) project, we evaluated the longitudinal changes over 3 years in quality of life (QoL) in patients with type 2 diabetes according to the presence or the development of erectile dysfunc- tion (ED). RESEARCH DESIGN AND METHODS — Patients were requested to fill in a question- naire investigating the presence of ED and QoL (SF-36 Health Survey, depression symptoms [Center for Epidemiologic Studies–Depression], and quality of sexual life) every 6 months for 3 years. The analyses were based on multilevel models, adjusted for patient clinical and sociode- mographic characteristics. RESULTS — The study involved 1,456 patients, of whom 34% reported frequent erectile problems at baseline; 192 developed ED during the follow-up. No changes in QoL measures were detected in patients without ED; in those with ED at baseline, a worsening in all SF-36 scales was observed, reaching statistical significance for physical functioning (P = 0.03). Among patients who developed ED during the study, a deterioration in all SF-36 dimensions and a worsening in depressive symptoms preceded the development of ED. The onset of ED was associated with a further marked worsening in physical functioning (P = 0.0008), general health perception (P = 0.02), and social functioning (P = 0.04) on SF-36 subscales, as well as in the summary physical and mental components scores (P = 0.04 and P = 0.07, respectively). The development of ED was also associated with a highly significant increase in depressive symptoms (P = 0.001) and a marked decrease in quality of sexual life (P  0.0001). CONCLUSIONS — This longitudinal study documents for the first time the impact of ED onset on several aspects of QoL in patients with type 2 diabetes. The study also shows that QoL tended to further decrease during 3 years in patients with ED at baseline but not in those without this condition. Diabetes Care 28:2637–2643, 2005 E rectile dysfunction (ED) has a broad negative impact on health-related quality of life (QoL) in patients with type 2 diabetes (1). An international mul- ticenter disease registry of men with ED has also shown that diabetic men with ED appear to have more severe dysfunction than nondiabetic men with ED and also present with worse disease-specific health-related QoL (2). Most of the information about the im- pact of ED on QoL comes from cross- sectional studies involving the general population (3–5). Information on pa- tients with diabetes is extremely scarce (1,2), particularly that describing the trend over time of QoL in patients with ED (2); furthermore, no data are available regarding the changes in QoL produced by the onset of ED. In the context of the QuED (Quality of Care and Outcomes in Type 2 Diabe- tes) project we have previously docu- mented the fact that patients with ED at study entry had a significantly worse QoL compared with those not suffering from this complication (1). The aim of this study was to describe the longitudinal changes over 3 years in QoL scores in pa- tients who developed ED during the study and in those who already had ED at study entry. RESEARCH DESIGN AND METHODS — The study design has already been described in detail elsewhere (1). Briefly, physicians were identified in all regions of Italy and selected according to their willingness to participate in the project. Overall, 114 diabetes outpatient clinics and 112 general practitioners par- ticipated in the study. All patients with type 2 diabetes were considered eligible for this project, irre- spective of age, duration of diabetes, and treatment. In diabetes outpatient clinics, patients were sampled by using random lists, stratified by patient age (65 or 65 years). Each center was asked to re- cruit at least 30 patients, whereas general practitioners enrolled only those patients for whom they were primarily responsible for diabetes care. Clinical information was abstracted from clinical records by the participating physicians and reported in ad hoc forms. Data were collected at base- line and at 6-month intervals for 3 years. Baseline clinical variables referred to the last value in the previous 12 months. Because normal ranges for HbA 1c varied among the different centers, the percent- age change with respect to the upper nor- mal value (actual value/upper normal limit) was estimated and multiplied by 6.0. Cardiovascular disease (CVD) in- cluded myocardial infarction, angina, ●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●● Address correspondence and reprint requests to Antonio Nicolucci, MD, Department of Clinical Pharma- cology and Epidemiology, Consorzio Mario Negri Sud, Via Nazionale 8/A, 66030 S. Maria Imbaro (CH), Italy. E-mail: nicolucci@negrisud.it. Received for publication 31 March 2005 and accepted in revised form 29 July 2005. *A complete list of QuED Study Group investigators can be found in the APPENDIX. Abbreviations: CES-D, Center for Epidemiologic Studies–Depression; CVD, cardiovascular disease; ED, erectile dysfunction; QoL, quality of life; TIBI, Total Illness Burden Index. A table elsewhere in this issue shows conventional and Syst` eme International (SI) units and conversion factors for many substances. © 2005 by the American Diabetes Association. The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact. Epidemiology/Health Services/Psychosocial Research O R I G I N A L A R T I C L E DIABETES CARE, VOLUME 28, NUMBER 11, NOVEMBER 2005 2637