Purpose The Intergroup 0116 trial has demonstrated that postoperative chemoradiotherapy (CRT) improves survival in gastric cancer. We retrospectively compared survival and recurrence patterns in... Show morePurpose The Intergroup 0116 trial has demonstrated that postoperative chemoradiotherapy (CRT) improves survival in gastric cancer. We retrospectively compared survival and recurrence patterns in two phase I/II studies evaluating more intensified postoperative CRT with those from the Dutch Gastric Cancer Group Trial (DGCT) that randomly assigned patients between D1 and D2 lymphadenectomy. Patients and Methods Survival and recurrence patterns of 91 patients with adenocarcinoma of the stomach who had received surgery followed by radiotherapy combined with fluorouracil and leucovorin (n = 5), capecitabine (n = 39), or capecitabine and cisplatin (n = 47) were analyzed and compared with survival and recurrence patterns of 694 patients from the DGCT (D1, n = 369; D2, n = 325). For both groups, the Maruyama Index of Unresected Disease (MI) was calculated and correlated with survival and recurrence patterns. Results With a median follow-up of 19 months in the CRT group, local recurrence rate after 2 years was significantly higher in the surgery only (DGCT) group (17% v 5%; P = .0015). Separate analysis of CRT patients who underwent a D1 dissection (n = 39) versus DGCT-D1 (n = 369) showed fewer local recurrences after chemoradiotherapy (2% v 8%; P = .001), whereas comparison of CRT-D2 (n = 25) versus DGCT-D2 (n = 325) demonstrated no significant difference. CRT significantly improved survival after a microscopically irradical (R1) resection. The MI was found to be a strong independent predictor of survival. Conclusion After D1 surgery, the addition of postoperative CRT had a major impact on local recurrence in resectable gastric cancer. Show less
Purpose The use of cytochrome P450 2D6-inhibiting drugs (CYP2D6 inhibitors) during tamoxifen treatment leads to a decrease in plasma concentration of endoxifen, the major active tamoxifen... Show morePurpose The use of cytochrome P450 2D6-inhibiting drugs (CYP2D6 inhibitors) during tamoxifen treatment leads to a decrease in plasma concentration of endoxifen, the major active tamoxifen metabolite. Concomitant use of CYP2D6 inhibitors, such as selective serotonin reuptake inhibitors, as well as low tamoxifen adherence may negatively impact tamoxifen efficacy in patients with breast cancer. The objectives of this study were to relate concomitant CYP2D6 inhibitor use and tamoxifen adherence to breast cancer event-free time (EFT). Patients and Methods Data were from PHARMO and included a community pharmacy dispensing database; PALGA, a nationwide pathology database; and the Dutch Medical Register in the Netherlands. Patients with breast cancer treated with adjuvant tamoxifen between 1994 and 2006 were included. A Cox proportional hazards model with a time-dependent definition for concomitant CYP2D6 inhibitor exposure was used. Adherence calculated over the first year after tamoxifen initiation was related to breast cancer events in the following period. Results In total, 1,962 patients with breast cancer using tamoxifen were included, among whom 150 (7.6%) frequently used a CYP2D6 inhibitor during tamoxifen treatment. No association between concomitant CYP2D6 inhibitor use and breast cancer recurrence was observed (adjusted hazard ratio [HR], 0.87; 95% CI, 0.42 to 1.79; P = .69). Poor tamoxifen adherence was associated with lower EFT (adjusted HR, 0.987; 95% CI, 0.975 to 0.999; P = .029). Conclusion This observational study did not show an association between concomitant CYP2D6 inhibitor use and breast cancer recurrence among patients treated with adjuvant tamoxifen despite the strong biologic rationale. This study shows, to the best of our knowledge for the first time, that poor tamoxifen adherence is associated with an increased risk of breast cancer events. Show less
Purpose: In a prospective 2-center study we confirmed and extended published results of the positive effect on post-prostatectomy stress incontinence of transobturator sling suspension using an... Show morePurpose: In a prospective 2-center study we confirmed and extended published results of the positive effect on post-prostatectomy stress incontinence of transobturator sling suspension using an Advance (TM) male sling. Materials and Methods: From September 2007 to June 2008 a male sling was placed and evaluated in 36 men according to the Rehder and Gozzi method. Diagnosis was based on 24-hour urine loss measured by a pad test, a 24-hour micturition frequency volume chart and cystoscopy. A visual analog scale for continence and bother, and a pad test were used preoperatively and postoperatively to objectively evaluate operative results. Results: At 1-year followup cure was achieved in 9.0% of patients and improvement was achieved in 45.5%. No effect on incontinence was seen in 36.5% of patients and 9.0% experienced worsening incontinence by pad test. The mean SD visual analogue scale score of 6.1 +/- 2.2 (range 0 to 10) preoperatively improved significantly to 4.6 +/- 3.0 at 3 months (p = 0.024) and not significantly to 4.9 +/- 3.1 by 1 year postoperatively (p = 0.39). Improved incontinence did not correlate with patient age or incontinence severity. Complications developed in 2 patients, including sling infection and postoperative urinary retention in 1 each. Conclusions: The transobturator sling suspension operation is a minimally invasive, safe procedure for male postoperative stress incontinence. Significantly improved continence was not observed on pad test but significant improvement in continence and bother was seen on the visual analog scale at 3 months. Show less
Beck, J.; Bekker, M.; Driel, M. van; Putter, H.; Pelger, R.; Nijeholt, A.A.B.L.A.; Elzevier, H.W. 2010
Introduction. There is a strong association between urological complaints and a history of sexual abuse, especially in females. It is not known whether urologists integrate these facts in their... Show moreIntroduction. There is a strong association between urological complaints and a history of sexual abuse, especially in females. It is not known whether urologists integrate these facts in their daily practice. Aim. To evaluate whether Dutch urologists address the issues of sexual abuse in their female patients and to evaluate their perception of sexual abuse prevalences. Methods. A five-item anonymous questionnaire was mailed to all 405 registered members of the Dutch Urology Association (urologists and residents). Main Outcome Measures. The results of the survey. Results. One hundred eighty-six surveys of eligible respondents were returned (45.9% response rate). A total of 68.8% stated that they always ask their female patients about sexual abuse before doing the physical examination. Overall, 79.3% said to do so when a patient has certain urological complaints: 77.6% in case of lower abdominal pain, 62.1% in urgency or frequency, 41.4% in incontinence, 29.3% in urinary tract infections, and 3.4% in hematuria. The majority of the respondents (74.3%) estimated the frequency of sexual abuse in their urological clinic to be equal or less than 10%. Conclusion. Nearly 70% of the responding Dutch urologists and residents ask their female patients about possible sexual abuse. They estimate the frequency of sexual abuse in their female patients to be equal or less than 10%. Beck J, Bekker M, Van Driel M, Putter H, Pelger R, Lycklama a Nijeholt AAB, and Elzevier HW. Female sexual abuse evaluation in the urological practice: Results of a dutch survey. J Sex Med 2010;7:1464-1468. Show less
BACKGROUND In the Netherlands, the Total Mesorectal Excision (TME) surgical technique for rectal cancer was introduced together with pre-operative radiotherapy in a quality controlled manner within... Show moreBACKGROUND In the Netherlands, the Total Mesorectal Excision (TME) surgical technique for rectal cancer was introduced together with pre-operative radiotherapy in a quality controlled manner within the framework of the TME trial (1996-1999). The aim of this study is to examine the effects of the structural changes in rectal cancer care on survival compared to colon cancer for patients treated before, during and after the TME trial. METHOD We compared overall survival of all patients with curatively resected colon (n = 15,266) and rectal cancer (n = 5839) in the regions of Comprehensive Cancer Centres South and West between 1990 and 2005, adjusting for prognostic variables. RESULTS In the pre-trial period, rectal cancer had a significant lower survival compared to colon cancer (HR 1.248, P < 0.01). However, in the post-trial period, survival after rectal cancer was similar to colon cancer (HR 0.987, n.s.). CONCLUSION Although survival improved significantly for both colon and rectal cancer in the last 15 years, the substantially worse results after rectal cancer have been eliminated. This study shows the lasting effects that structural surgical training and quality assurance can have on survival outcome. Show less
PURPOSE: The use of cytochrome P450 2D6-inhibiting drugs (CYP2D6 inhibitors) during tamoxifen treatment leads to a decrease in plasma concentration of endoxifen, the major active tamoxifen... Show morePURPOSE: The use of cytochrome P450 2D6-inhibiting drugs (CYP2D6 inhibitors) during tamoxifen treatment leads to a decrease in plasma concentration of endoxifen, the major active tamoxifen metabolite. Concomitant use of CYP2D6 inhibitors, such as selective serotonin reuptake inhibitors, as well as low tamoxifen adherence may negatively impact tamoxifen efficacy in breast cancer patients. The objectives of this study were to relate concomitant CYP2D6 inhibitor use and tamoxifen adherence to breast cancer event-free time (EFT). PATIENTS AND METHODS: Data were from PHARMO and included a community pharmacy dispensing database; PALGA, a nationwide pathology database; and the Dutch Medical Register in the Netherlands. Breast cancer patients treated with adjuvant tamoxifen between 1994 and 2006 were included. A Cox proportional hazards model with a time-dependent definition for concomitant CYP2D6 inhibitor exposure was used. Adherence calculated over the first year after tamoxifen initiation was related to breast cancer events in the following period. RESULTS: In total, 1,962 breast cancer patients using tamoxifen were included, among whom 150 (7.6%) frequently used a CYP2D6 inhibitor during tamoxifen treatment. No association between concomitant CYP2D6 inhibitor use and breast cancer recurrence was observed (adjusted hazard ratio [HR], 0.87; 95% CI, 0.42 to 1.79; P = .69). Poor tamoxifen adherence was associated with lower EFT (adjusted HR, 0.987; 95% CI, 0.975 to 0.999; P = .029). CONCLUSION: This observational study did not show an association between concomitant CYP2D6 inhibitor use and breast cancer recurrence among patients treated with adjuvant tamoxifen despite the strong biologic rationale. This study shows, to the best of our knowledge for the first time, that poor tamoxifen adherence is associated with an increased risk of breast cancer events. Show less
Hage, J.A. van der; Mieog, J.S.D.; Vijver, M.V. van de; Bartelink, H.; Putter, H.; Velde, C.J.H. van de 2010
To assess survival and to construct a baseline mortality risk score in primary prevention implantable cardioverter defibrillator (ICD) patients with non-ischaemic or ischaemic heart disease. Since... Show moreTo assess survival and to construct a baseline mortality risk score in primary prevention implantable cardioverter defibrillator (ICD) patients with non-ischaemic or ischaemic heart disease. Since 1996, data of all consecutive patients who received an ICD system in the Leiden University Medical Center were collected and assessed at implantation. For the current study, all 1036 patients [age 63 (SD 11) years, 81% male] with a primary indication for defibrillator implantation were evaluated and followed for 873 (SD 677) days. During follow-up, 138 patients (13%) died. Non-ischaemic and ischaemic patients demonstrated similar survival but exhibited different factors that influence risk for mortality. A risk score, consisting of simple baseline variables could stratify patients in low, intermediate, and high risk for mortality. In non-ischaemic patients, annual mortality was 0.4% (95% CI 0.0-2.2%) in low risk and 9.4% (95% CI 6.6-13.1%) in high risk patients. In ischaemic patients, mortality was 1.0% (95% CI 0.2-3.0%) in low risk and 17.8% (95% CI 13.6-22.9%) in high risk patients. Utilization of an easily applicable baseline risk score can create an individual patient-tailored estimation on mortality risk to aid clinicians in daily practice. Show less
BACKGROUND: After surgery for intermediate-risk endometrial carcinoma, the vagina is the most frequent site of recurrence. This study established whether vaginal brachytherapy (VBT) is as effective... Show moreBACKGROUND: After surgery for intermediate-risk endometrial carcinoma, the vagina is the most frequent site of recurrence. This study established whether vaginal brachytherapy (VBT) is as effective as pelvic external beam radiotherapy (EBRT) in prevention of vaginal recurrence, with fewer adverse effects and improved quality of life. METHODS: In this open-label, non-inferiority, randomised trial undertaken in 19 Dutch radiation oncology centres, 427 patients with stage I or IIA endometrial carcinoma with features of high-intermediate risk were randomly assigned by a computer-generated, biased coin minimisation procedure to pelvic EBRT (46 Gy in 23 fractions; n=214) or VBT (21 Gy high-dose rate in three fractions, or 30 Gy low-dose rate; n=213). All investigators were masked to the assignment of treatment group. The primary endpoint was vaginal recurrence. The predefined non-inferiority margin was an absolute difference of 6% in vaginal recurrence. Analysis was by intention to treat, with competing risk methods. The study is registered, number ISRCTN16228756. FINDINGS: At median follow-up of 45 months (range 18-78), three vaginal recurrences had been diagnosed after VBT and four after EBRT. Estimated 5-year rates of vaginal recurrence were 1.8% (95% CI 0.6-5.9) for VBT and 1.6% (0.5-4.9) for EBRT (hazard ratio [HR] 0.78, 95% CI 0.17-3.49; p=0.74). 5-year rates of locoregional relapse (vaginal or pelvic recurrence, or both) were 5.1% (2.8-9.6) for VBT and 2.1% (0.8-5.8) for EBRT (HR 2.08, 0.71-6.09; p=0.17). 1.5% (0.5-4.5) versus 0.5% (0.1-3.4) of patients presented with isolated pelvic recurrence (HR 3.10, 0.32-29.9; p=0.30), and rates of distant metastases were similar (8.3% [5.1-13.4] vs 5.7% [3.3-9.9]; HR 1.32, 0.63-2.74; p=0.46). We recorded no differences in overall (84.8% [95% CI 79.3-90.3] vs 79.6% [71.2-88.0]; HR 1.17, 0.69-1.98; p=0.57) or disease-free survival (82.7% [76.9-88.6] vs 78.1% [69.7-86.5]; HR 1.09, 0.66-1.78; p=0.74). Rates of acute grade 1-2 gastrointestinal toxicity were significantly lower in the VBT group than in the EBRT group at completion of radiotherapy (12.6% [27/215] vs 53.8% [112/208]). INTERPRETATION: VBT is effective in ensuring vaginal control, with fewer gastrointestinal toxic effects than with EBRT. VBT should be the adjuvant treatment of choice for patients with endometrial carcinoma of high-intermediate risk. FUNDING: Dutch Cancer Society. Show less
BACKGROUND: After surgery for intermediate-risk endometrial carcinoma, the vagina is the most frequent site of recurrence. This study established whether vaginal brachytherapy (VBT) is as effective... Show moreBACKGROUND: After surgery for intermediate-risk endometrial carcinoma, the vagina is the most frequent site of recurrence. This study established whether vaginal brachytherapy (VBT) is as effective as pelvic external beam radiotherapy (EBRT) in prevention of vaginal recurrence, with fewer adverse effects and improved quality of life. METHODS: In this open-label, non-inferiority, randomised trial undertaken in 19 Dutch radiation oncology centres, 427 patients with stage I or IIA endometrial carcinoma with features of high-intermediate risk were randomly assigned by a computer-generated, biased coin minimisation procedure to pelvic EBRT (46 Gy in 23 fractions; n=214) or VBT (21 Gy high-dose rate in three fractions, or 30 Gy low-dose rate; n=213). All investigators were masked to the assignment of treatment group. The primary endpoint was vaginal recurrence. The predefined non-inferiority margin was an absolute difference of 6% in vaginal recurrence. Analysis was by intention to treat, with competing risk methods. The study is registered, number ISRCTN16228756. FINDINGS: At median follow-up of 45 months (range 18-78), three vaginal recurrences had been diagnosed after VBT and four after EBRT. Estimated 5-year rates of vaginal recurrence were 1.8% (95% CI 0.6-5.9) for VBT and 1.6% (0.5-4.9) for EBRT (hazard ratio [HR] 0.78, 95% CI 0.17-3.49; p=0.74). 5-year rates of locoregional relapse (vaginal or pelvic recurrence, or both) were 5.1% (2.8-9.6) for VBT and 2.1% (0.8-5.8) for EBRT (HR 2.08, 0.71-6.09; p=0.17). 1.5% (0.5-4.5) versus 0.5% (0.1-3.4) of patients presented with isolated pelvic recurrence (HR 3.10, 0.32-29.9; p=0.30), and rates of distant metastases were similar (8.3% [5.1-13.4] vs 5.7% [3.3-9.9]; HR 1.32, 0.63-2.74; p=0.46). We recorded no differences in overall (84.8% [95% CI 79.3-90.3] vs 79.6% [71.2-88.0]; HR 1.17, 0.69-1.98; p=0.57) or disease-free survival (82.7% [76.9-88.6] vs 78.1% [69.7-86.5]; HR 1.09, 0.66-1.78; p=0.74). Rates of acute grade 1-2 gastrointestinal toxicity were significantly lower in the VBT group than in the EBRT group at completion of radiotherapy (12.6% [27/215] vs 53.8% [112/208]). INTERPRETATION: VBT is effective in ensuring vaginal control, with fewer gastrointestinal toxic effects than with EBRT. VBT should be the adjuvant treatment of choice for patients with endometrial carcinoma of high-intermediate risk. FUNDING: Dutch Cancer Society. Show less
Background After surgery for intermediate-risk endometrial carcinoma, the vagina is the most frequent site of recurrence. This study established whether vaginal brachytherapy (VBT) is as effective... Show moreBackground After surgery for intermediate-risk endometrial carcinoma, the vagina is the most frequent site of recurrence. This study established whether vaginal brachytherapy (VBT) is as effective as pelvic external beam radiotherapy (EBRT) in prevention of vaginal recurrence, with fewer adverse effects and improved quality of life. Methods In this open-label, non-inferiority, randomised trial undertaken in 19 Dutch radiation oncology centres, 427 patients with stage I or IIA endometrial carcinoma with features of high-intermediate risk were randomly assigned by a computer-generated, biased coin minimisation procedure to pelvic EBRT (46 Gy in 23 fractions; n=214) or VBT (21 Gy high-dose rate in three fractions, or 30 Gy low-dose rate; n=213). All investigators were masked to the assignment of treatment group. The primary endpoint was vaginal recurrence. The predefined non-inferiority margin was an absolute difference of 6% in vaginal recurrence. Analysis was by intention to treat, with competing risk methods. The study is registered, number ISRCTN16228756. Findings At median follow-up of 45 months (range 18-78), three vaginal recurrences had been diagnosed after VBT and four after EBRT. Estimated 5-year rates of vaginal recurrence were 1.8% (95% CI 0.6-5.9) for VBT and 1.6% (0.5-4-9) for EBRT (hazard ratio [HR] 0.78, 95% CI 0-17-3.49; p=0.74). 5-year rates of locoregional relapse (vaginal or pelvic recurrence, or both) were 5.1% (2.8-9.6) for VBT and 2.1% (0.8-5.8) for EBRT (HR 2.08,0.71-6.09; p=0.17). 1.5% (0.5-4.5) versus 0.5% (0.1-3.4) of patients presented with isolated pelvic recurrence (HR 3.10, 0.32-29.9; p=0.30), and rates of distant metastases were similar (8.3% [5.1-13.4] vs 5.7% [3.3-9.9]; HR 1.32, 0.63-2.74; p=0.46). We recorded no differences in overall (84-8% [95% CI 79.3-90.3] vs 79.6% [71.2-88.0]; HR 1.17, 0.69-1.98; p=0.57) or disease-free survival (82.7% [76.9-88.6] vs 78.1% [69.7-86.5]; HR 1.09, 0.66-1.78; p=0.74). Rates of acute grade 1-2 gastrointestinal toxicity were significantly lower in the VBT group than in the EBRT group at completion of radiotherapy (12.6% [27/215] vs 53.8% [112/208]). Interpretation VBT is effective in ensuring vaginal control, with fewer gastrointestinal toxic effects than with EBRT. VBT should be the adjuvant treatment of choice for patients with endometrial carcinoma of high-intermediate risk. Show less
Although denial in cancer patients is often seen in clinical practice, studies relating denial to physical outcomes are lacking. The present study aims to investigate patterns of denial among lung... Show moreAlthough denial in cancer patients is often seen in clinical practice, studies relating denial to physical outcomes are lacking. The present study aims to investigate patterns of denial among lung cancer patients and connect these to their physical outcomes. Denial was measured longitudinally in 195 consecutive newly diagnosed lung cancer patients. Four assessments were conducted over an 8-month period. Patient-reported physical outcomes were measured with a generic and disease-specific quality of life measure. Medical data were provided by the patients' chest physicians. Three patterns of denial over time were identified in lung cancer patients: patients displayed either low, moderate or increasing denial. Male lung cancer patients were found to deny at a moderate level more often. A moderate or increasing level of denial was consistently related to improved patient-rated physical outcomes. Lung cancer patients displaying more denial reported a better overall perception of health and better physical functioning. They complained less about fatigue, nausea and vomiting, appetite loss, dysphagia and pain in arm and shoulder than low deniers. Other symptoms did not differ among denial classes. Denial in lung cancer patients may well be an adaptive mechanism and have to be respected in clinical practice. (C) 2009 Elsevier Ireland Ltd. All rights reserved. Show less
OBJECTIVE: To investigate the validity and responsiveness of the World Health Organization Disability Schedule II (WHODAS II) in patients with established RA. METHODS: In 85 RA patients admitted... Show moreOBJECTIVE: To investigate the validity and responsiveness of the World Health Organization Disability Schedule II (WHODAS II) in patients with established RA. METHODS: In 85 RA patients admitted for rehabilitation, the WHODAS II (0-100) was applied at admission and 6 weeks after discharge. Additional assessments included measures of physical and psychological functioning, disease activity and quality of life. The internal consistency of the WHODAS II was determined with Cronbach's-alpha. Associations between the WHODAS II and other outcome measures were determined by Pearson's rank correlation coefficients. Responsiveness measures included the standardized response mean (SRM), effect size (ES) and responsiveness ratio (RR). RESULTS: Cronbach's-alpha of the WHODAS II total score was 0.91. The baseline WHODAS II total score correlated significantly with all other outcome measures, except for the 50-feet walk test, the timed-stands test and the Escola Paulista de Medicina Range of Motion scale. The mean WHODAS II total score improved from 40.5 (s.d. 14.9) at baseline to 4.6 at 6 weeks after discharge (95% CI -8.1, -1.2). The WHODAS II responsiveness scores were -0.35 (SRM), -0.34 (ES) and -0.58 (RR) at 6 weeks after discharge. CONCLUSION; The WHODAS II appeared to be internally consistent, valid and responsive to assess disability in patients with established RA admitted for multidisciplinary team care in terms of International Classification of Functioning, Disability and Health. The WHODAS II showed significant floor effects regarding the subscales--'understanding communicating' and 'getting along with people'. In a multidisciplinary setting, the additional use of measures to evaluate personal and environmental factors seems warranted. Show less
Diagnostic tests play an important role in clinical practice. The objective of a diagnostic test accuracy study is to compare an experimental diagnostic test with a reference standard. The majority... Show moreDiagnostic tests play an important role in clinical practice. The objective of a diagnostic test accuracy study is to compare an experimental diagnostic test with a reference standard. The majority of these studies dichotomize test results into two categories: negative and positive. But often the underlying test results may be categorized into more than two, ordered, categories. This article concerns the situation where multiple studies have evaluated the same diagnostic test with the same multiple thresholds in a population of non-diseased and diseased individuals. Recently, bivariate meta-analysis has been proposed for the pooling of sensitivity and specificity, which are likely to be negatively correlated within studies. These ideas have been extended to the situation of diagnostic tests with multiple thresholds, leading to a multinomial model with multivariate normal between-study variation. This approach is efficient, but computer-intensive and its convergence is highly dependent on starting values. Moreover, monotonicity of the sensitivities/specificities for increasing thresholds is not guaranteed. Here, we propose a Poisson-correlated gamma frailty model, previously applied to a seemingly quite different situation, meta-analysis of paired survival curves. Since the approach is based on hazards, it guarantees monotonicity of the sensitivities/specificities for increasing thresholds. The approach is less efficient than the multinomial/normal approach. On the other hand, the Poisson-correlated gamma frailty model makes no assumptions on the relationship between sensitivity and specificity, gives consistent results, appears to be quite robust against different between-study variation models, and is computationally very fast and reliable with regard to the overall sensitivities/specificities. Show less
Objective. To investigate the validity and responsiveness of the World Health Organization Disability Schedule II (WHODAS II) in patients with established RA. Methods. In 85 RA patients admitted... Show moreObjective. To investigate the validity and responsiveness of the World Health Organization Disability Schedule II (WHODAS II) in patients with established RA. Methods. In 85 RA patients admitted for rehabilitation, the WHODAS II (0-100) was applied at admission and 6 weeks after discharge. Additional assessments included measures of physical and psychological functioning, disease activity and quality of life. The internal consistency of the WHODAS II was determined with Cronbach's-alpha. Associations between the WHODAS II and other outcome measures were determined by Pearson's rank correlation coefficients. Responsiveness measures included the standardized response mean (SRM), effect size (ES) and responsiveness ratio (RR). Results. Cronbach's-alpha of the WHODAS II total score was 0.91. The baseline WHODAS II total score correlated significantly with all other outcome measures, except for the 50-feet walk test, the timed-stands test and the Escola Paulista de Medicina Range of Motion scale. The mean WHODAS II total score improved from 40.5 (S. D. 14.9) at baseline to 4.6 at 6 weeks after discharge (95% CI -8.1, -1.2). The WHODAS II responsiveness scores were -0.35 (SRM), -0.34 (ES) and -0.58 (RR) at 6 weeks after discharge. Conclusion. The WHODAS II appeared to be internally consistent, valid and responsive to assess disability in patients with established RA admitted for multidisciplinary team care in terms of International Classification of Functioning, Disability and Health. The WHODAS II showed significant floor effects regarding the subscales-'understanding communicating' and 'getting along with people'. In a multidisciplinary setting, the additional use of measures to evaluate personal and environmental factors seems warranted. Show less
