Clinical Characteristics Of Participants Research Articles

Sources of site differences in the efficacy of a multisite clinical trial: The treatment of SSRI-resistant depression in adolescents.

Site differences in treatment outcomes are not often highlighted when the results of multisite randomized clinical trials (MRCTs) are reported. The primary analyses of a 6-site MRCT, the Treatment of SSRI-Resistant Depression in Adolescents (TORDIA) study, showed substantial variation by site in the performance of a medication-only condition and a combined medication plus cognitive-behavioral therapy (CBT) condition. Two potential primary causes of site differences in MRCT outcomes were examined in this article: sampling factors, particularly clinical characteristics of participants, and treatment protocol factors, particularly fidelity. The authors found that differences in the clinical characteristics of participants at baseline across site and within site/across conditions were the most salient explanations for site differences and differences within sites across conditions in outcome. Study findings are discussed with respect to the overall study outcomes in TORDIA as well as MRCTs in general.

Treatment‐emergent mania/hypomania in unipolar patients

The aim of this study was to estimate the incidence of treatment-emergent mania/hypomania (TEMH) and to describe the clinical characteristics of patients with major depression experiencing this event during treatment with a selective serotonin reuptake inhibitor (SSRI) and/or interpersonal psychotherapy (IPT). Following an algorithm-based protocol, 344 patients with major depression confirmed with the Structured Clinical Interview for DSM-IV disorders were treated with an SSRI, interpersonal psychotherapy, or their combination for nine months. The emergence of mania/hypomania was carefully monitored throughout the study using the Young Mania Rating Scale and clinical assessment. Overall, eight patients experienced TEMH. The incidence of this event was 3.0% in patients treated with an SSRI and 0.9% in patients treated with IPT alone. Among patients treated with an SSRI, the difference between sites was higher than expected by chance alone (6.8% at Pisa and 0% at Pittsburgh, p = 0.002). Despite the adoption of an identical protocol at the two sites, some demographic and clinical characteristics of participants may account for this unexpected result. Alternatively, the greater number of episodes and earlier age of onset at the Pittsburgh site suggests that the unipolar course of illness was more clearly established prior to study entry. TEMH is an infrequent event, occurring in 2.3% of patients treated for major depression. Nevertheless, its consequences are clinically relevant and require prompt and appropriate therapeutic interventions. For this reason, recognising those patients at risk for such an event is of paramount clinical significance. The observed difference in the incidence of TEMH between the two sites requires further investigation.

Resistance Training for Medial Compartment Knee Osteoarthritis and Malalignment

1) To evaluate the effects of a 12-wk high-intensity knee extensor and flexor resistance training program on strength, pain, and adherence in patients with advanced knee osteoarthritis and varus malalignment and 2) to generate pilot data for change in dynamic knee joint load, patent-reported outcomes, and self-efficacy after training. Fourteen patients (48.35 +/- 6.51 yr) with radiographically confirmed medial compartment knee osteoarthritis and varus malalignment of the lower limb were recruited from a surgical waiting list for high tibial osteotomy. Participants completed a high-intensity isokinetic resistance training program three times per week for 12 wk. Knee extensor and flexor strength were assessed every third week, whereas pain and adherence were recorded at every training session. The external knee adduction moment during the gait, the 6-min-walk test, the Knee Injury and Osteoarthritis Outcome Score (KOOS), and the Arthritis Self-Efficacy Scale (ASES) were also evaluated before and after training. Significant improvements in knee extensor and flexor strength were observed without increases in pain during or after training. Adherence to the high-intensity program was high. No significant changes were observed for dynamic knee joint load or the KOOS. There was a significant increase in the function subscale of the ASES only. These findings suggest that patients with advanced knee osteoarthritis and malalignment can experience substantial gains in strength after a high-intensity resistance training program without concomitant increases in pain, adverse events, or compromised adherence. These findings provide support for future clinical trials with longer-term outcomes.

Treatment Seeking for Depression in Canada and the United States

Treatment Seeking for Depression in Canada and the United States

The association between metabolic control and prevalent macrovascular disease in Type 2 diabetes: The VA Cooperative Study in diabetes

The problem Macrovascular disease (MVD), especially coronary heart disease, is the most common cause of mortality in Type 2 diabetes. We assessed the association between demographic and clinical variables (particularly HbA1c) and prevalent MVD at time of enrollment into the VA Diabetes Trial (VADT), a 7-year randomized trial to determine whether intensive glycemic control will reduce risk of MVD events in older participants with established Type 2 diabetes. Research design and methods We compared the demographic, treatment, and clinical characteristics of participants with and without known MVD, then assessed the interaction of multiple variables with HbA1c. Logistic regression models evaluated the association between HbA1c quartiles and prevalence of MVD, adjusting for potentially confounding variables. Results Several variables were associated with prevalent MVD (age, duration of diabetes, insulin use but not daily dosage, smoking history, hypertension, BMI, Caucasian race, non-Hispanic ethnicity, lower HDL cholesterol, higher triglycerides, lower LDL cholesterol, and statin use). In univariate analysis, there was no association of HbA1c with MVD (mean: 9.4±1.46% in those with MVD, 9.5±1.58% in those without). Multivariate analyses found little confounding of the lack of association of HbA1c with MVD. Only adjustment for age produced a slight increase in the odds ratio, but only for the highest quartile of HbA1c. Conclusions In this cross-sectional analysis, MVD was associated with a number of clinical and demographic variables but not with HbA1c. Determining whether intensive lowering of HbA1c will reduce the prospective rate of MVD events in this population of older participants with established Type 2 diabetes is the primary objective of our trial.

Long-term follow-up of renal transplantation in children: a Dutch cohort study.

Few data exist on long-term morbidity, overall survival, and graft survival of pediatric renal transplantation. The authors performed a long-term cohort study in all Dutch patients, born before 1979, with onset of end-stage renal disease (ESRD) between 1972 and 1992 at age 0 to 15 years. Data on graft survival and determinants of outcome were obtained by reviewing all medical charts. The health status was assessed by cross-sectional examination of surviving patients. Three hundred ninety-seven transplantations were performed in 231 of all 249 patients, of whom 25 died with a functioning graft. Cardiovascular disease was the most prominent cause of death. Graft survival estimates for all transplantations were 59.2%, 45.3%, 35.4%, and 30.3% at 5, 10, 15, and 20 years, respectively. In comparison with azathioprine, cyclosporine as the immunosuppressant was associated with increased graft survival in retransplantations but not in first transplantations. Cross-sectional examination was performed on 110 patients. In 44 patients, the most recent graft survival exceeded 15 years. Co-morbidity was found in 40% of all patients; motor, hearing, or visual disabilities were found in 19%. Bone disease, headaches, itching, and tremors were the most reported disabling problems. Cyclosporine use was associated with hypertension and a history of epilepsy. Compared with all age-matched Dutch inhabitants, the educational attainment was low, and unemployment and parental dependency were high. The authors' results emphasize the need for reducing cardiovascular disease and metabolic bone disease in pediatric ESRD, a policy toward less toxic antirejection therapy, a more strict treatment of hypertension, and more attention for schooling and social development toward independence.

Quality of life in adults with end-stage renal disease since childhood is only partially impaired.

Little is known about the quality of life of adults with end-stage renal disease (ESRD) since childhood. In a long-term follow-up study, we assessed quality of life in these patients and compared their outcomes with those in the general population and in dialysis patients with adult-onset of ESRD. All Dutch adult patients with onset of ESRD at age 0-14 years between 1972 and 1992 were asked to complete the RAND-36 questionnaire. We obtained clinical information by reviewing all available medical charts, and by current history. Patient scores were compared with those of age-matched healthy controls and with those of patients with adult onset of dialysis, of whom data were derived from a national study on the adequacy of dialysis (NECOSAD-2). We obtained a complete RAND-36 score in 131 of 187 surviving patients. Clinical characteristics of participants and non-participants were similar. Compared with the general population, we found a higher prevalence of impaired quality of life in dialysis patients in the following domains: physical functioning, role limitations due to physical health, social functioning (SF), general health perception (GH) and physical component summary. In other domains, impaired quality of life was equally or less prevalent (mental component summary). In transplanted patients, only impaired GH and SF were more prevalent. In dialysis patients with adult ESRD onset, impaired quality of life was more prevalent than in the general population in all domains, except in emotional role limitations. Dialysis patients with paediatric ESRD have an impaired physical quality of life, but in contrast to dialysis patients with adult ESRD onset, they have a normal mental quality of life.

Impaired cognition and schooling in adults with end stage renal disease since childhood

Aims: To determine cognitive and educational attainment in adults with end stage renal disease (ESRD) since childhood. Methods: All Dutch patients with onset of ESRD at age 0–14 years between...