Friederike Kendel

Screening for depression: Rasch analysis of the dimensional structure of the PHQ-9 and the HADS-D

BACKGROUND Both the depression modules of the Hospital Anxiety and Depression Scale (HADS-D) and the Patient Health Questionnaire (PHQ-9) are widely used for the screening of depression. We analyzed the dimensionality and the item fit of both scales individually and across the scales. Moreover, we sought to identify items which evidenced item response bias associated with age and gender. METHODS The depression subscales HADS-D and the PHQ-9 were administered to 1271 patients (mean age 67.2; 22.5% women) undergoing coronary artery bypass graft surgery (CABG). Rasch analyses were performed to assess the overall fit of the model, individual item fit and differential item functioning (DIF). RESULTS Rasch analysis revealed that the HADS-D and the PHQ-9 feature a common core construct containing six items of the HADS-D and three items of the PHQ-9. Two of these items are identical with the 2-item short form of the PHQ-9. In addition, fatigability was the only somatic item that fitted the model. No substantial DIF was observed. LIMITATIONS The generalizability of these results might be restricted to patients awaiting CABG. CONCLUSIONS The short form of the PHQ-9 seems to be an economic and valid instrument for the screening of depression, which indicates the same latent construct that is captured by six items of the HADS-D. Further studies are needed to evaluate whether the addition of fatigability might enhance the validity of the PHQ-2 in this patient population.

Post-Void Residual Urine as a Predictor of Urinary Tract Infection—Is There a Cutoff Value in Asymptomatic Men?

PURPOSE Post-void residual urine can lead to various complications, including urinary tract infection. Recently investigators calculated that a cutoff value of 180 ml has considerably high sensitivity and specificity for significant bacteriuria in asymptomatic men. We determined the association between post-void residual urine volume and urinary tract infection, and validated the suggested 180 ml cutoff in asymptomatic men. MATERIALS AND METHODS In a prospective study we analyzed certain criteria in 225 asymptomatic male patients, including prostate specific antigen, prostate volume, International Prostate Symptom Score, peak urine flow rate, urine culture results and post-void residual urine volume using transabdominal ultrasound. Using ROC analysis a cutoff predicting bacteriuria was calculated. Different cutoff values were validated. RESULTS Of the study group 60% were able to completely empty the bladder and had a post-void residual urine volume of 10 ml or less. However, in 31% of the study group urine culture was positive. Patients presenting with urinary tract infection had significantly higher mean post-void residual urine volume than patients without urinary tract infection (113 vs 41 ml, p <0.001). In 29 men (13%) post-void residual volume was 180 ml or greater. Confirming urinary tract infection, this cutoff showed only 28% sensitivity and 94% specificity (AUC 0.606, p = 0.01). CONCLUSIONS No cutoff value could be determined to predict positive urine culture with sufficient sensitivity and specificity. Based on the results of the current study it seems premature to recommend a cutoff value leading to therapeutic consequences.

Gender Differences in Health-related Quality of Life After Coronary Bypass Surgery: Results From a 1-year Follow-up in Propensity-matched Men and Women

Objective: To examine whether the predictive value of gender for health-related quality of life (HRQoL) is independent of clinical health status and depression. Women undergoing coronary bypass surgery generally report a poorer HRQoL than men. Methods: A total of 990 (20% women) patients completed study questionnaires 1 day before coronary bypass surgery and 1 year after surgery. Physical aspects of HRQoL were assessed with the Short Form 36 Health Survey. Depression was measured with the self-reported Patient Health Questionnaire. Propensity score matching was applied to match men and women with respect to 65 clinical variables. Of 198 women, 157 (79.3%) could be matched to a partner, resulting in an excellent balance of clinical variables between the matched groups. Results: At baseline, propensity-matched men and women differed in physical functioning (p < .001) and role functioning (p = .007), but not in bodily pain and general health perception. In both men and women, HRQoL outcomes improved over 1 year. Preoperative depression predicted worse physical HRQoL in all outcomes, except general health perception 1 year after surgery. After adjusting for depression, gender lost its predictive power with respect to physical functioning. However, compared with women, men still reported a better role functioning. Conclusion: Our data suggest that gender is a marker for role functioning, independent of the clinical health status and depression. Rehabilitation measures designed for the specific needs of women might help to improve their HRQoL. CABG = coronary artery bypass graft; PF = physical functioning; RP = role functioning; BP = bodily pain; GH = general health; SF-36 = Medical Outcomes Study 36-Item Short Form Health Survey.

Impact of clinical variables on predicting disease-free survival of patients with surgically resected renal cell carcinoma

OBJECTIVE To determine the value of particular clinical variables for the preoperative prognostic Cindolo formula (PPCF) to predict disease‐free survival (DFS) of patients with surgically treated renal cell carcinoma (RCC).

Impact of macroscopic tumour necrosis to predict survival of patients with surgically resected renal cell carcinoma.

Objective. The determination of further prognostic factors is essential for the establishment of risk groups for patients with surgically treated renal cell carcinoma (RCC). The objective of this study was to validate the prognostic value of macroscopic tumour necrosis, concerning postoperative survival. Material and methods. A total of 607 patients (387 men, 220 women), who had undergone surgical treatment for RCC, was retrospectively reviewed. Necrotic areas in the tumour were identified macroscopically followed by microscopic confirmation. Cancer-specific survival (CSS) and overall survival (OS) were estimated using the Kaplan–Meier method. Univariate and multivariate Cox proportional hazards regression models were fitted to determine associations between tumour necrosis, clinical and pathological features, and survival. In 447 patients who were still alive at the end of the study, median follow-up was 66 months (mean 71.2 months). Results. Tumour necrosis was identified in 25.5% of patients (n=155). After 5years, CSS and OS in the group of patients with tumour necrosis amounted to 77.0% and 64.4%, respectively, compared with 89.8%and 81.9% in the group of patients without tumour necrosis (in each case p<0.001). Patients with tumour necrosis significantly more often showed a metastatic stage, lymph-node involvement, a higher pathological tumour stage, a higher grading and a larger tumour size. In addition, a more frequent appearance of microvascular invasion and thrombocytosis could be proven in patients with tumour necrosis in comparison to patients without these histopathological findings. On multivariate regression analysis, only metastatic stage, lymph-node involvement, platelet count >400/nl and tumour necrosis remained significant for survival (CSS, OS). Conclusions. According to the results, tumour necrosis may be a useful factor in the prognostic assessment of patients with RCC. The integration of this parameter in prognostic models for postoperative survival is recommended.

[Adjuvant autologous tumour cell vaccination in patients with renal cell carcinoma. Overall survival analysis with a follow-up period in excess of more than 10 years].

BACKGROUND Organ-confined renal cell carcinoma (RCC) is associated with tumour progression after surgical therapy in approximately 30% of cases. However, of all recently available adjuvant treatment options, only the autologous tumour cell lysate vaccination therapy (Reniale) has been able to demonstrate a significant positive impact on progression-free survival in a phase III trial. Nevertheless, this therapeutic option has not yet been established as a standard adjuvant treatment. MATERIALS AND METHODS Between August 1993 and December 1996, a total of 1,267 patients who underwent radical tumour nephrectomy at 84 German centres received Reniale outside a controlled trial. Of these patients, 692 presented at stage pT2-3, pNx-2, M0 (based on the 4th version of TNM classification). These patients were matched with a cohort of 861 patients not receiving any adjuvant treatment who underwent surgical therapy for RCC in a 15-year period in the Carl-Thiem-Klinikum in Cottbus, Germany. Matching criteria included age, gender, pT stage, pN stage, grading, histological cell type, and UICC stage. This resulted in 495 matched pairs (study group n=990) that were comparable regarding demographic and tumour-specific criteria. Statistical analyses included univariate and multivariate analyses of overall survival (OS). Median follow-up time of all patients still alive at the end of the trial (n=667) was 11 years. RESULTS In the vaccine group, OS after 5 and 10 years was 80.6% and 68.9%, respectively, whereas control patients had an OS of 79.2% and 62.1%, respectively (p=0.066). The 5-year OS of patients with pT3 RCC was 71.3% after vaccination therapy and 65.4% for control patients. After 10 years, 53.6% of the patients in the vaccine group and 36.2% in the control group were still alive (p=0.022). Median survival of patients with pT3 RCC was 81 months (SD 7.8) in the control group. This period was not achieved in the vaccine group. Multivariate Cox analysis revealed a significant positive impact of Reniale on OS among the whole study group [hazard ratio (HR) 1.28, p=0.030]. The analysis of patient subgroups showed a significant positive influence of Reniale for patients presenting with pT3 tumours (HR 1.67, p=0.001). CONCLUSION Adjuvant postsurgical treatment with Reniale in patients presenting with stage pT3 RCC results in a significant enhancement of OS and should be considered especially in this group of patients. Further clinical trials integrating the recent TNM classification and comprising different risk constellations should follow in order to ultimately assess the value of adjuvant treatment with vaccination immunotherapy.

Adjuvante autologe Tumorvakzine beim Nierenzellkarzinom

BACKGROUND Organ-confined renal cell carcinoma (RCC) is associated with tumour progression after surgical therapy in approximately 30% of cases. However, of all recently available adjuvant treatment options, only the autologous tumour cell lysate vaccination therapy (Reniale) has been able to demonstrate a significant positive impact on progression-free survival in a phase III trial. Nevertheless, this therapeutic option has not yet been established as a standard adjuvant treatment. MATERIALS AND METHODS Between August 1993 and December 1996, a total of 1,267 patients who underwent radical tumour nephrectomy at 84 German centres received Reniale outside a controlled trial. Of these patients, 692 presented at stage pT2-3, pNx-2, M0 (based on the 4th version of TNM classification). These patients were matched with a cohort of 861 patients not receiving any adjuvant treatment who underwent surgical therapy for RCC in a 15-year period in the Carl-Thiem-Klinikum in Cottbus, Germany. Matching criteria included age, gender, pT stage, pN stage, grading, histological cell type, and UICC stage. This resulted in 495 matched pairs (study group n=990) that were comparable regarding demographic and tumour-specific criteria. Statistical analyses included univariate and multivariate analyses of overall survival (OS). Median follow-up time of all patients still alive at the end of the trial (n=667) was 11 years. RESULTS In the vaccine group, OS after 5 and 10 years was 80.6% and 68.9%, respectively, whereas control patients had an OS of 79.2% and 62.1%, respectively (p=0.066). The 5-year OS of patients with pT3 RCC was 71.3% after vaccination therapy and 65.4% for control patients. After 10 years, 53.6% of the patients in the vaccine group and 36.2% in the control group were still alive (p=0.022). Median survival of patients with pT3 RCC was 81 months (SD 7.8) in the control group. This period was not achieved in the vaccine group. Multivariate Cox analysis revealed a significant positive impact of Reniale on OS among the whole study group [hazard ratio (HR) 1.28, p=0.030]. The analysis of patient subgroups showed a significant positive influence of Reniale for patients presenting with pT3 tumours (HR 1.67, p=0.001). CONCLUSION Adjuvant postsurgical treatment with Reniale in patients presenting with stage pT3 RCC results in a significant enhancement of OS and should be considered especially in this group of patients. Further clinical trials integrating the recent TNM classification and comprising different risk constellations should follow in order to ultimately assess the value of adjuvant treatment with vaccination immunotherapy.

Validation of a postoperative prognostic model consisting of tumor microvascular invasion, size, and grade to predict disease‐free and cancer‐specific survival of patients with surgically resected renal cell carcinoma

Objectives:  To determine the value of microvascular invasion, tumor size, and Fuhrman grade to predict the survival of patients with surgically resected renal cell carcinoma (RCC).

Patients' perceptions of mortality risk for localized prostate cancer vary markedly depending on their treatment strategy

Treatment choice for localized prostate cancer (PCa) is a controversial issue, and mortality risk is probably the most decisive factor in this regard. The study aimed to compare prostate‐cancer‐specific mortality risk estimates for different treatment options assigned by patients managed with active surveillance (AS), radical prostatectomy (RP) and patients who had discontinued AS (DAS). Patients initially managed with AS or RP (N = 370) were matched according to length of therapy. All patients completed mailed questionnaires assessing their mortality risk estimates (in %) and prostate‐cancer‐specific anxiety. Differences in risk estimates among the three treatment groups were analyzed using ANOVA, relationships of clinical and psychosocial variables with risk estimates using standard multiple regression. In all treatment groups, the prostate‐ cancer‐specific mortality risk was overestimated. This applied whether it was the patients own treatment or the alternative treatment option. RP patients assigned a mortality risk to AS that was almost three times higher than that assigned to RP (50.9 ± 25.0 vs. 17.8 ± 19.7, d = 1.48; p < 0.001). Anxiety was significantly associated with risk estimates for AS (p = 0.008) and RP (p = 0.001). Compared with clinical data that suggest that the prostate‐cancer‐specific mortality risk for AS is low and does not significantly differ from that for RP, patients strongly overestimated the mortality risk. This was most markedly so in RP patients, who drastically overestimated the benefits of RP compared to the risk of AS. This overestimation could increase overtreatment and should therefore be corrected by better patient education.

Delay in diagnosis of muscle disorders depends on the subspecialty of the initially consulted physician

BackgroundNew therapeutic strategies in muscular dystrophies will make a difference in prognosis only if they are begun early in the course of the disease. Therefore, we investigated factors that influence the time to diagnosis in muscle dystrophy patients.MethodsA sample of 101 patients (mean age 49 years; range 19-80; 44% women) with diagnosed muscle dystrophies from neurological practices and the neuromuscular specialty clinic in Berlin, Germany, was invited to participate. Time from first consultation to diagnosis, subspecialty of physician, and sociodemographic data were assessed with self-report questionnaires. The association between time to diagnosis and potential predictors (subspecialty of initially consulted physician, diagnoses, gender, and age at onset) was modeled with linear regression analysis.ResultsThe mean time span between first health-care contact and diagnosis was 4.3 years (median 1). The diagnostic delay was significantly longer if patients were initially seen by a non-neurological specialist compared to a general practitioner (5.2 vs. 3.5 years, p = 0.047). Other factors that were independently associated with diagnostic delay were female gender and inherited muscle disease.ConclusionAction to improve clinical awareness of muscle diseases in non-neurological specialists is needed.