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Reported Erectile Dysfunction

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Reported Erectile Dysfunction Epidemiology/Health Services/Psychosocial Research ORIGINAL ARTICLE Longitudinal Assessment of Quality of Life in Patients With Type 2 Diabetes and Self- Reported Erectile Dysfunction GIORGIA DE BERARDIS, MSCPHARMCHEM MICHELE SACCO, MD sectional studies involving the general FABIO PELLEGRINI, MSCSTAT GIANNI TOGNONI, MD population (3–5). Information on pa- MONICA FRANCIOSI, MSCBIOLS MIRIAM VALENTINI, MD tients with diabetes is extremely scarce MAURIZIO BELFIGLIO, MD ANTONIO NICOLUCCI, MD (1,2), particularly that describing the BARBARA DI NARDO, HSDIP ON BEHALF OF THE QUED (QUALITY OF trend over time of QoL in patients with SHELDON GREENFIELD, MD CARE AND OUTCOMES IN TYPE 2 ED (2); furthermore, no data are available SHERRIE H. KAPLAN, PHD, MPH DIABETES)STUDY GROUP* regarding the changes in QoL produced MARIA C.E. ROSSI, MSCPHARMCHEM by the onset of ED. In the context of the QuED (Quality of Care and Outcomes in Type 2 Diabe- OBJECTIVE — In the context of the QuED (Quality of Care and Outcomes in Type 2 Dia- tes) project we have previously docu- 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- mented the fact that patients with ED at tion (ED). study entry had a significantly worse QoL compared with those not suffering from RESEARCH DESIGN AND METHODS — Patients were requested to fill in a question- this complication (1). The aim of this naire investigating the presence of ED and QoL (SF-36 Health Survey, depression symptoms study was to describe the longitudinal [Center for Epidemiologic Studies–Depression], and quality of sexual life) every 6 months for 3 changes over 3 years in QoL scores in pa- years. The analyses were based on multilevel models, adjusted for patient clinical and sociode- tients who developed ED during the study mographic characteristics. and in those who already had ED at study entry. 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 RESEARCH DESIGN AND was observed, reaching statistical significance for physical functioning (P ϭ 0.03). Among METHODS — The study design has patients who developed ED during the study, a deterioration in all SF-36 dimensions and a already been described in detail elsewhere worsening in depressive symptoms preceded the development of ED. The onset of ED was (1). Briefly, physicians were identified in ϭ associated with a further marked worsening in physical functioning (P 0.0008), general health all regions of Italy and selected according perception (P ϭ 0.02), and social functioning (P ϭ 0.04) on SF-36 subscales, as well as in the ϭ ϭ to their willingness to participate in the summary physical and mental components scores (P 0.04 and P 0.07, respectively). The project. Overall, 114 diabetes outpatient development of ED was also associated with a highly significant increase in depressive symptoms (P ϭ 0.001) and a marked decrease in quality of sexual life (P Ͻ 0.0001). clinics and 112 general practitioners par- ticipated in the study. CONCLUSIONS — This longitudinal study documents for the first time the impact of ED All patients with type 2 diabetes were onset on several aspects of QoL in patients with type 2 diabetes. The study also shows that QoL considered eligible for this project, irre- tended to further decrease during 3 years in patients with ED at baseline but not in those without spective of age, duration of diabetes, and this condition. treatment. In diabetes outpatient clinics, patients were sampled by using random Diabetes Care 28:2637–2643, 2005 lists, stratified by patient age (Ͻ65 or Ն65 years). Each center was asked to re- rectile dysfunction (ED) has a broad appear to have more severe dysfunction cruit at least 30 patients, whereas general negative impact on health-related than nondiabetic men with ED and also practitioners enrolled only those patients E quality of life (QoL) in patients with present with worse disease-specific for whom they were primarily responsible type 2 diabetes (1). An international mul- health-related QoL (2). for diabetes care. Clinical information was ticenter disease registry of men with ED Most of the information about the im- abstracted from clinical records by the has also shown that diabetic men with ED pact of ED on QoL comes from cross- participating physicians and reported in ●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●● ad hoc forms. Data were collected at base- Address correspondence and reprint requests to Antonio Nicolucci, MD, Department of Clinical Pharma- line and at 6-month intervals for 3 years. cology and Epidemiology, Consorzio Mario Negri Sud, Via Nazionale 8/A, 66030 S. Maria Imbaro (CH), Baseline clinical variables referred to Italy. E-mail: [email protected]. the last value in the previous 12 months. Received for publication 31 March 2005 and accepted in revised form 29 July 2005. Because normal ranges for HbA varied *A complete list of QuED Study Group investigators can be found in the APPENDIX. 1c Abbreviations: CES-D, Center for Epidemiologic Studies–Depression; CVD, cardiovascular disease; ED, among the different centers, the percent- erectile dysfunction; QoL, quality of life; TIBI, Total Illness Burden Index. age change with respect to the upper nor- A table elsewhere in this issue shows conventional and Syst`eme International (SI) units and conversion mal value (actual value/upper normal factors for many substances. limit) was estimated and multiplied by © 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 6.0. Cardiovascular disease (CVD) in- marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact. cluded myocardial infarction, angina, DIABETES CARE, VOLUME 28, NUMBER 11, NOVEMBER 2005 2637 Erectile dysfunction and QoL coronary revascularization procedures, composed of 20 items addressing symp- performed using SAS Statistical Package, stroke, and lower limb complications toms of depression during the previous 4 version 8.2 (13). (claudication, ulcer, gangrene, amputa- weeks. Values of the CES-D Scale range tion, and aortic-femoral revascularization from 0 to 60 with higher values indicating RESULTS — The study involved procedures). more severe depressive symptoms (9). 1,456 patients, of whom 500 patients All subjects were asked to complete a (34%) reported frequent erectile prob- questionnaire upon entry into the study lems at study entry and 192 patients Quality of sexual life and at 6-month intervals over a period of (13.2%) developed ED during the follow- We evaluated the quality of sexual life us- 3 years. The questionnaire was self- up. Patients’ characteristics according to ing the Sexual Life Questionnaire com- administered and then sent anonymously the presence or development of ED are posed of six items. The score ranges to the coordinating center in prepaid en- reported in Table 1. Patients who devel- between 0 and 100, with higher values velopes. The matching between clinical oped ED were older; had longer duration indicating better quality of sexual life. De- data and the questionnaire was made pos- of diabetes, worse metabolic control, and tails on the questionnaire validation have sible through a code put by the physician a higher TIBI score; and were more often been reported in a previous paper (1). on both sources of information. No other treated with insulin and affected by hy- details on patient identity were contained pertension, neuropathy, micro- or mac- neither in the questionnaire nor in clinical Statistical analysis roalbuminuria, or CVD compared with data. Patients’ characteristics according to the those without ED. With respect to pa- The presence of ED was investigated presence/development of ED were com- tients with ED at baseline, those who de- by asking the patient how often he had pared using the ␹2 test for categorical vari- veloped ED during the follow up were less experienced problems in achieving and ables and the Mann-Whitney U test for often treated with insulin, less likely to maintaining an erection during the past 6 continuous variables. Changes in QoL have retinopathy, and showed a lower months, with responses calibrated on a scores during the study were calculated as TIBI score. 5-level scale (from never to more than the difference between baseline and last The analysis of QoL scores during 3 once per week). We considered only follow-up value and compared using the years of follow-up showed that no major those patients who reported frequent paired t test. Effect sizes were calculated changes were present among patients erectile problems (almost every week or by dividing the changes in each QoL score without ED, except for a slight improve- more than once a week) as being affected by the SD of that score estimated at base- ment in depressive symptoms (P ϭ by ED. Incident cases of ED were consid- line on the entire sample. 0.016) (Table 2). In individuals with ED ered those patients without ED at baseline To account for the hierarchical nature at baseline we documented a worsening who reported frequent erectile problems of the data (repeated measurements in the physical dimensions of the SF-36, during the follow-up. The presence and within patients) and to control simulta- which reached the statistical significance severity of diabetes complications and co- neously for the possible confounding ef- for physical functioning (P ϭ 0.003) and morbidities were summarized by using fects of the different variables, we utilized the physical component summary mea- the Total Illness Burden Index (TIBI), a multivariate multilevel linear models sure (P ϭ 0.008).
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