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PubMed2006

Relationship between primary Gleason pattern on needle biopsy and clinicopathologic outcomes among men with Gleason score 7 adenocarcinoma of the prostate.

OBJECTIVES: To examine the relationship among needle biopsy primary grade, prostatectomy grade, and postprostatectomy biochemical recurrence among men with Gleason score 7 disease. METHODS: We identified 320 men with Gleason score 7 tumors on prostate biopsy treated with radical prostatectomy between 1991 and 2001 by a single surgeon. None of these patients had received neoadjuvant or adjuvant hormonal therapy or radiotherapy. The chi-square test and Kaplan-Meier method were used to evaluate the correlation among biopsy Gleason score, prostatectomy Gleason score, and biochemical recurrence. RESULTS: A total of 252 (79%) and 68 (21%) men had primary Gleason pattern 3 and 4 identified on needle biopsy, respectively. Of the patients with Gleason pattern 3 + 4 tumors on biopsy, 24% were upgraded to primary pattern 4 or more on final pathologic analysis. Of the patients with Gleason pattern 4 + 3 tumors on biopsy, 47% were downgraded to primary pattern 3 or less on final pathologic analysis. The actuarial risk of biochemical prostate-specific antigen recurrence was significantly lower among patients with Gleason pattern 4 + 3 on biopsy, if the prostatectomy Gleason score was downgraded to 3 + 4 or less (P = 0.03). CONCLUSIONS: Approximately 47% of men with a diagnosis of Gleason pattern 4 + 3 on needle biopsy are downgraded at radical prostatectomy and will have biochemical prostate-specific antigen recurrence-free outcomes similar to patients originally diagnosed with Gleason pattern 3 + 4 adenocarcinoma. This group of patients may benefit from definitive treatment such as radical prostatectomy for management of their disease.

Adenocarcinoma↗
PubMedDate not supplied

A prognostic score for colorectal cancer.

BACKGROUND/AIMS: Scoring systems are generally used for predicting prognosis in critically ill patients, but not frequently for predicting prognosis in cancer. Our aim was to develop a prognostic score for colorectal cancer. METHODOLOGY: Demographic, clinical, laboratory, radiologic, histopathologic and operative data of 112 patients who had resection for colorectal cancer, were analyzed for their effect on survival. Eight variables (invasion depth of tumor, nodal status, presence of metastasis, CEA level, differentiation, resectability, tumor location, presence of blood transfusion), which have the most significant effect on survival in univariate analysis and multivariate analysis, were chosen. Coefficients were calculated and the Prognostic Score for Colorectal Cancer (PSCRC) was designed. All patients were scored using this system and staged according to TNM, Dukes and Astler-Coller systems. RESULTS: The score range is between -49 and 80. Patients were grouped as Group 1 (score < -30), Group 2 (score -30 to -6), Group 3 (score -5 to 19), Group 4 (score > 19). Survival rates decreased and recurrence rates increased significantly with increasing scores. The associations of PSCRC and staging systems with survival and recurrence rates were determined by logistic and Cox regression analyses. PSCRC was proved to have the most significant association with survival and recurrence rates. Furthermore, PSCRC had better correlation with survival and recurrence rates when compared with staging systems according to Pearson correlation analysis. CONCLUSIONS: Inclusion of more variables in PSCRC seems to make it superior to the staging systems. PSCRC may be a practical and useful scoring system in clinical practice and is easily adapted to different patient populations.

Adult↗
PubMed2005

Arthroscopic versus open Bankart repair: analysis of patient subjective outcome and cost.

PURPOSE: Although the comparative efficacy of open and arthroscopic Bankart repair remains a matter of debate, little data exist on relative costs. We analyzed the patient outcomes, cost, and resource utilization of both procedures to determine if differences exist between open versus arthroscopic Bankart repair. TYPE OF STUDY: Retrospective case-control study. METHODS: We compared 22 patients who had open Bankart repair with 20 patients who had arthroscopic Bankart repair. Total operating times and all charges were obtained from records. Patients were evaluated using the American Shoulder and Elbow Surgeons (ASES) shoulder score, and any recurrence of dislocation was noted at minimum 24-month follow-up. RESULTS: For arthroscopic Bankart repairs, operating times were shorter, but operating room equipment charges were greater. Overall charges were greater for open repairs as all open repair patients were admitted postoperatively. ASES shoulder scores were not significantly different between treatment groups. Four of 17 evaluable patients with open Bankart repair (including 1 shoulder in a patient who underwent bilateral repairs) had recurrent dislocation. One of the 18 evaluable patients with arthroscopic Bankart repair had recurrent dislocation. CONCLUSIONS: Arthroscopic Bankart repair as same-day surgery has lower overall charges than open repair, although this difference would be negligible if all patients went home immediately after surgery. LEVEL OF EVIDENCE: Level III, therapeutic, retrospective cohort study.

Adolescent↗
PubMed2005

Impact of superficial bladder cancer and transurethral resection on general health-related quality of life: an SF-36 survey.

OBJECTIVES: To assess the general health-related quality of life (GHQOL) of patients with superficial bladder cancer who underwent transurethral resection (TUR). METHODS: We assessed the GHQOL a total of 178 times for 133 patients with superficial bladder cancer before multiple TURs. The GHQOL was assessed using the Medical Outcome Study Short-Form 36-item survey (SF-36). Ninety-three patients answered the questionnaire at the first TUR, 34 at the second TUR, 17 at the third TUR, and 34 at the fourth or later TUR. RESULTS: Compared with age-matched and sex-matched Japanese norms, the general health perception was severely impaired in patients with superficial bladder cancer. Their mental health was also severely impaired at the first TUR, but gradually returned to normal as TUR was repeated. The scores of physical functioning, social functioning, and role-emotional demonstrated a nadir at the second or third TUR, and increased thereafter if TUR was repeated four or more times. Intravesical treatment for prevention of recurrence increased the score of bodily pain. CONCLUSIONS: Although superficial bladder cancer is not frequently lethal, patients with this disease believed their general health was much impaired. Only two domains of bodily pain and vitality had no negative impact from this disease. As urologists, we should notice the considerable affect of superficial bladder cancer on the GHQOL of patients.

Aged↗
PubMed1988

Local recurrence of papillary thyroid carcinoma after unilateral or bilateral thyroidectomy.

Because prospective, randomized studies on papillary carcinoma of the thyroid are lacking, the results of retrospective studies from the basis of our present knowledge. To assess differences in treatment modalities, the patient groups must be comparable. A prognostic score has been devised by the use of multivariate analysis which can accurately distinguish patients at various levels of risk for disease-related mortality. To obtain the score, the calculated contributions of four significant variables are added. These variables are Age, tumor Grade, Extent, and Size (AGES). Using this scoring system, locally recurrent papillary thyroid carcinoma was studied in 816 patients primarily treated at the Mayo Clinic between 1946 and 1970. Locally recurrent disease developed in 54 (6.6%) patients, with the highest risk of occurrence in the first five years following initial thyroidectomy. Both in low- and high-risk patients, patients who had undergone unilateral thyroid resection had significantly more local recurrences than those with bilateral resections. However, there was no such difference when comparing subtotal to total thyroidectomy. Even though local disease was the cause of death in over one-half of the patients who died of thyroid cancer, this represented less than two percent of the entire series. From analysis of these data, bilateral resection - but not necessarily total thyroidectomy - with specific care to preserve both recurrent laryngeal nerves and at least one parathyroid gland in situ, seems to provide optimal treatment. When recurrence does occur, it appears worthwhile to attempt further surgical resection.

Adolescent↗
PubMedDate not supplied

The long-term perspective: a study of psychopathology and health status of patients with a history of depression more than 15 years after the first episode.

This article examines psychopathology, functioning, well-being, social support, and coping-behavior of family practice patients with a history of depressive illness, both with and without recurrences. Results of depressive patients were compared with each other and with those of "normal" controls. The patients belonged to the four practices of the Continuous Morbidity Registry of the University of Nijmegen, Netherlands. Their first episode of depression for each patient was more than 15 years ago. Data were collected with the Symptom Checklist (SCL-90) the RAND-36, the Social Support List (SSL-12), and the short Utrecht Coping List (UCL-k). Psychopathology scores of patients without recurrences were higher than "normal" controls and lower than patients with recurrences. The same pattern was found concerning health status. No significant differences were found between the groups in social support but patients with recurrences had a lower score of emotional coping than patients without recurrences or normal patients. That even a long time after an episode of depression, patients have higher levels of a variety of psychopathology than controls has implications for every-day practice as it calls for a longer and more critical follow-up of depression by clinicians.

Activities of Daily Living↗
PubMed1997

Hepatitis G virus coinfection in hepatitis C virus-infected liver transplant recipients.

BACKGROUND: In this study, we determined the prevalence of hepatitis G virus (HGV) infection in end-stage hepatitis C virus (HCV)-related liver disease and examined the influence of HGV coinfection on the outcome of liver transplantation. METHODS: HGV was detected by reverse transcriptase-polymerase chain reaction and Southern blotting in sera drawn from 159 patients who were known to be HCV infected before transplantation. Patients were followed up for a mean of 28.4 months after transplantation. RESULTS: Forty-one (25.3%) patients were HGV positive and the prevalence of HGV infection was similar for different HCV genotypes. Both HGV-positive and -negative groups had similar survival, recurrence rates, inflammatory activity scores, and degree of fibrosis at the time of recurrence. CONCLUSION: Infection with HGV is common in end-stage HCV-infected patients presenting for liver transplantation. It influences neither the outcome of liver transplantation nor the recurrence of hepatitis in the graft.

Adult↗
PubMed1998

Long-term results of radiation therapy for prostate cancer recurrence following radical prostatectomy.

PURPOSE: Following radical prostatectomy, radiation therapy may be beneficial in select patients with isolated local recurrence. Pathological stage, Gleason score and the timing of prostate specific antigen (PSA) elevation are useful in distinguishing men with local recurrence from those with distant metastases. We test the ability of these criteria to predict long-term suppression of PSA recurrence following post-prostatectomy radiation therapy. MATERIALS AND METHODS: Of 1,699 men treated with radical prostatectomy from 1982 to 1995, 82 with an isolated PSA elevation or local recurrence following surgery underwent radiation therapy to the prostatic bed and were followed for at least 2 years. No patient had evidence of metastases at the time of radiation. RESULTS: Of the men 17 (21%) had an undetectable PSA (less than 0.2 ng./ml.) for 2 or greater years following radiation. The 5-year actuarial PSA recurrence-free rate after radiation was 10%. PSA remained at undetectable levels for 2 or greater years in no patients with Gleason score 8 or greater (12 cases), positive seminal vesicles (12) or positive lymph nodes (3), and in only 1 of 16 men (6%) who had a PSA recurrence within 1 year of prostatectomy. As the interval to PSA recurrence increased, the likelihood of responding to radiotherapy increased to 44% if initial disease detection occurred 5 or more years after prostatectomy. There was no demonstrated advantage to radiating men with an isolated PSA elevation before a documented local recurrence. CONCLUSIONS: Patients with Gleason score 8 or greater, positive seminal vesicles or lymph nodes, or a PSA recurrence within the first year following surgery rarely benefit from radiation therapy. As the interval to PSA recurrence increases, the likelihood of responding to radiation therapy increases substantially. These parameters are useful in the selection of patients with prostate cancer recurrences who are likely to benefit from radiation to the prostatic bed.

Follow-Up Studies↗
PubMed2005

Cadaveric prolapse repair with sling: intermediate outcomes with 6 months to 5 years of followup.

PURPOSE: We present the prospective, intermediate-term results for cadaveric prolapse repair with sling as combined treatment of stress urinary incontinence and cystocele. MATERIALS AND METHODS: A total of 251 of 295 (85%) patients undergoing cadaveric prolapse repair with sling (CaPS) had at least 6 months of questionnaire and pelvic examination followup. All patients had objectively demonstrated stress urinary incontinence and grade 2 to 4 cystocele before surgery. Followup outcome measures included a validated subjective continence and patient satisfaction questionnaire, SEAPI (stress incontinence, emptying, anatomy, protection, inhibition) scores, pelvic examination for prolapse recurrence and complications, and quality of life scores. RESULTS: The overall patient reported subjective incontinence cured/dry rate (no incontinence episodes of any type) was 114 of 251 (45%), the cured/improved rate (50% improvement or greater) was 192 of 251 (76%) and the failed rate (less than 50% improvement) was 59 of 251 (24%). When considering stress urinary incontinence the cured/dry rate was 141 of 251 (56%), cured/improved rate was 207 of 251 (82%) and failed rate was 44 of 251 (17.5%), with 17 of the 44 (39%) cases having mixed urinary incontinence. Of the 59 failures 33 (56%) occurred after 12 months of followup. Of 153 patients 13 (8.5%) experienced de novo urge incontinence. The symptomatic cystocele recurrence rate was 18 of 251 (7%). There were statistically significant improvements in SEAPI and prolapse quality of life scores. Of 251 patients 200 (80%) were at least 50% satisfied and of 251 193 (77%) stated they would undergo the CaPS procedure again. CONCLUSIONS: With a maximum followup of 5 years in patients undergoing CaPS, we have seen excellent, durable cystocele repair results. While our subjective continence rates have decreased with an increasing number of late failures, we continue to observe significant improvement in SEAPI scores and quality of life with good patient satisfaction and low morbidity.

Adult↗
PubMedDate not supplied

A randomized study between excision and marsupialization and radiofrequency sinus excision in sacro-coccygeal pilonidal disease.

BACKGROUND: The surgical approach to pilonidal sinus disease is open to debate. This prospective, randomized study was aimed to compare the outcome of the excision and marsupialization and the sinus excision technique by radiofrequency. MATERIALS AND METHODS: Thirty patients of chronic pilonidal sinus disease were randomly assigned to radiofrequency sinus excision (n = 15) and excision and marsupialization (n = 15). The parameters measured included intraoperative and postoperative data, wound-related complications, and recurrence. Patient satisfaction score was assessed at 1-year follow-up. RESULTS: The operation time, postoperative pain, hospital stay, and off work periods were significantly less (p < 0.05) in the technique employing radiofrequency surgery. At 1-year follow-up, there was 1 case of recurrence in each group. The patients from radiofrequency group expressed better satisfaction than the patients operated by marsupialization. CONCLUSION: Radiofrequency sinus excision technique needs a shorter hospital stay with reduced postoperative pain and early resumption to work in comparison with the sinus excision and marsupialization technique.

Adolescent↗
PubMed1998

Predictors of recurrence of fulminant bacterial peritonitis after discontinuation of antibiotics in open management of the abdomen.

OBJECTIVE: To assess a scoring system for predicting recurrence of fulminant bacterial peritonitis after discontinuation of antimicrobial treatment in patients being treated by open management of the abdomen for persistent bacterial peritonitis after perforation of the digestive tract, anastomotic disruption, or necrotising pancreatitis. DESIGN: Retrospective study. SETTING: University Hospital, The Netherlands. SUBJECTS: 58 consecutive patients. MAIN OUTCOME MEASUREMENTS: Recurrence of fulminant bacterial peritonitis and survival. RESULTS: 13 of the 58 patients (22%) died during the initial course of antimicrobial drugs. 14 of the remaining 45 patients had a recurrence of fulminant bacterial peritonitis after discontinuation of antimicrobial drugs, 4 of whom died. Predictive criteria included raised white cell count (WCC) (p = 0.02), duration of initial antibiotic treatment (p = 0.05), and deterioration in Simplified Acute Physiology Score (p = 0.05). Using the WCC and the duration of initial antimicrobial treatment together with other variables that showed a predictive trend (body temperature, percentage band cells, underlying disease, and use of inotropic agents), in a new scoring system (0-12), fulminant bacterial peritonitis did not recur when the score was 0-3, but in 9 of 11 patients with a score of 6 or more it did (p < 0.001). CONCLUSION: Patients at increased risk of recurrence of fulminant bacterial peritonitis during open management of the abdomen can be identified at the time of discontinuation of antimicrobial treatment by a new scoring system; antimicrobial treatment should not be discontinued in patients with a score of 6 or more.

Adult↗
PubMed2004

Long-term follow-up of patients with suspected deep vein thrombosis of the upper extremity: survival, risk factors and post-thrombotic syndrome.

BACKGROUND: The outcome of upper extremity thrombosis in terms of morbidity, mortality and arm functionality is virtually unknown. We investigated mortality, risk factors, recurrent thrombosis and post-thrombotic syndrome (PTS) in patients with suspected upper extremity thrombosis. METHODS: Consecutive patients suspected of having deep vein thrombosis (DVT) of the upper extremity were followed for up to 53 months (mean 21 months). Venography and/or ultrasonography was used for diagnosis. Risk factors were identified from history and thrombophilia laboratory screening. PTS was assessed using a scoring system. Death, recurrent thrombosis and PTS were primary outcome measures. RESULTS: DVT of the upper extremity was diagnosed in 50 of 116 consecutive patients (43%). Malignancy and/or central venous lines were present in 37 of 50 (74%) patients with thrombosis. Inherited thrombophilia was diagnosed in 6 of 30 (20%) and 4 of 33 (12%) of the investigated patients with and without thrombosis, respectively (not significant). Twenty-five patients (50%) with thrombosis died during the follow-up period; this was associated with cancer in 84% of the deaths. Recurrent thrombosis was observed in four patients (8%) during follow-up. Symptoms of PTS were present in 4 of 22 patients (18%) with thrombosis and in 14 of 36 patients (39%) in whom thrombosis was excluded. CONCLUSIONS: Malignancy and central venous lines are major risk factors of upper extremity thrombosis. Thrombophilia seems to be unrelated to the presence or absence of upper extremity thrombosis. Thrombosis in combination with malignancy predicts poor survival. A scoring system can be used to assess the severity of PTS, but it does not discriminate PTS from other causes of arm complaints.

Journal Article↗
PubMed1997

Comparison of two different modes for noninvasive mechanical ventilation in chronic respiratory failure: volume versus pressure controlled device.

The most commonly used mode of noninvasive mechanical ventilation (NMV) is volume-controlled intermittent positive pressure ventilation (IPPV). Pressure support ventilation has recently become increasingly popular, but its merits have not been clearly defined. In an open, nonrandomized follow-up study, we evaluated two modes of NMV, volume-controlled (IPPV) and pressure-controlled ventilation (PCV) over 6 months in 30 consecutive patients (24 males and 6 females, aged 49 +/- 19 yrs) with chronic respiratory failure (CRF). The baseline assessments comprised both physiological and subjective data. In all cases, nasal IPPV was initially administered for 1 month, followed by a second month of nasal PCV. Thereafter, responders or nonresponders to PCV were defined according to the patients' subjective symptom score and/or the recurrence of hypercapnia. During the IPPV phase, in all but two patients the subjective and objective parameters improved significantly. During the following 1 month PCV phase, stabilization was maintained in 18 patients ("responders"), while 10 patients were defined as "nonresponders". In nonresponders, hypercapnia increased (arterial carbon dioxide tension (Pa,CO2): 5.7 +/- 0.4 to 6.6 +/- 0.5 kPa; p < 0.05) and symptom scores decreased. Compared with responders, nonresponders had a lower mean nocturnal arterial oxygen saturation (Sa,O2) (p < 0.05) and a higher daytime Pa,CO2 (p < 0.05) at baseline. We con clude that the majority of patients suffering from chronic respiratory failure who are initially satisfactorily ventilated with intermittent positive pressure ventilation may also be adequately maintained with pressure-controlled ventilation. However, there is a subgroup with more severe chronic respiratory failure at baseline, in whom pressure-controlled ventilation is inadequate. After 4 weeks of treatment with pressure-controlled ventilation, the subjective scores and the arterial carbon dioxide tension values reliably distinguished between long-term responders and nonresponders to pressure-controlled ventilation.

Adult↗
PubMed1994

Prediction of pathologic stage and postprostatectomy disease recurrence by DNA ploidy analysis of initial needle biopsy specimens of prostate cancer.

BACKGROUND: DNA ploidy determination of carcinomas in radical prostatectomy specimens has shown significant correlation with patient outcome, but the predictive value of ploidy status of cancers obtained by transrectal ultrasound-guided needle biopsies has not been studied extensively. METHODS: Eighty-nine paired needle biopsy specimens (NBX) and radical prostatectomy (RPX) specimens from patients with early clinical stage (A2-B2) prostate cancer were evaluated for DNA content by image analysis of Feulgen stained tissue sections. Findings were compared with Gleason grading on the same specimens by univariate and multivariate analyses for prediction of local tumor invasion, metastasis, disease recurrence, and serum prostate specific antigen concentration during a 0.9-6.0 year clinical follow-up period. RESULTS: There was excellent correlation of ploidy status between NBX and RPX specimens (P < 0.0001); NBX and RPX grades did not correlate. On RPX specimens, aneuploid status correlated with high tumor grade (P < 0.0005). Aneuploidy in NBX specimens was associated with a twofold higher rate of extracapsular spread (ECS) (P = 0.04). Aneuploid NBX tumors featured a tenfold greater frequency of metastasis than did diploid NBX tumors (P < 0.005). Radical prostatectomy grade correlated with ECS (P < 0.001) and presence of metastatic disease (P = 0.04). On multivariate logistic regression analysis, aneuploidy in both NBX and RPX specimens was the most significant variable and independently predicted the presence of metastasis (P = 0.006 for NBX; P = 0.028 for RPX). Tumor grade of NBX and RPX specimens did not independently predict metastatic disease or disease recurrence, but RPX grade was associated independently with ECS (P = 0.005). Aneuploid NBX tumors recurred after RPX three times more often than did diploid cases, which was significant on univariate (P < 0.001) and multivariate (P = 0.018) analyses using the Cox proportional hazards model. There was no correlation with NBX or RPX Gleason score and disease recurrence. Preoperative serum PSA concentration did not correlate with tumor grade or ploidy status, but on multivariate analysis, when paired with ploidy status, independently contributed to the propensity for ECS, metastasis, and disease recurrence. CONCLUSIONS: DNA content analysis of early clinical stage prostate carcinoma needle biopsy specimens by image analysis directly correlates with radical prostatectomy specimen ploidy status and is associated independently, with the presence of metastasis, postprostatectomy disease recurrence, and ECS. Needle biopsy tumor grading did not correlate with prostatectomy grade and did not predict disease outcome accurately.

Aged↗
PubMed2026

ALID score for treatment-effect heterogeneity of adjunctive low-voltage area ablation in persistent atrial fibrillation: A post hoc analysis of SUPPRESS-AF.

BACKGROUND: In persistent atrial fibrillation (AF), the incremental benefit of adjunctive low-voltage area (LVA) ablation beyond pulmonary vein isolation (PVI) remains inconsistent. OBJECTIVE: To examine whether a simple clinical score characterizes treatment-effect heterogeneity of adjunctive LVA ablation among patients with mapped LVA&#xa0;>&#xa0;5&#xa0;cm2 and to perform an exploratory supportive analysis in an independent randomized cohort. METHODS: In this post-hoc analysis of SUPPRESS-AF, which included patients with persistent AF and mapped LVA&#xa0;>&#xa0;5&#xa0;cm2 after PVI, four variables-age&#xa0;&#x2265;&#xa0;75&#xa0;years, left atrial diameter&#xa0;>&#xa0;44&#xa0;mm, estimated glomerular filtration rate&#xa0;<&#xa0;60&#xa0;mL/min/1.73&#xa0;m2, and absence of diabetes-were combined into the ALID score (0-4). Patients were stratified into low (0-1), intermediate (2), and high (3-4) score groups. Because EARNEST-PVI did not use LVA-guided ablation or select patients based on mapped LVA, it was analyzed as an exploratory supportive cohort rather than as an external validation cohort. RESULTS: In SUPPRESS-AF (n&#xa0;=&#xa0;336), a significant treatment-by-score interaction was observed (P&#xa0;<&#xa0;0.001). Adjunctive LVA ablation was associated with increased recurrence in the low-score stratum (HR 3.92; 95% CI 1.50-10.20) and reduced recurrence in the high-score stratum (HR 0.48; 95% CI 0.26-0.86). In EARNEST-PVI (n&#xa0;=&#xa0;494), a qualitatively similar interaction pattern was observed for additional ablation beyond PVI (interaction P&#xa0;=&#xa0;0.029), although the ablation strategy differed from LVA-guided ablation. CONCLUSIONS: Among patients with persistent AF and mapped LVA >5&#xa0;cm2, the ALID score identified heterogeneity in response to adjunctive LVA ablation. These hypothesis-generating findings require prospective validation before clinical implementation.

Humans↗
PubMed2003

Development and validation of disease-specific measures for choroidal melanoma: COMS-QOLS report No. 2.

OBJECTIVE: To develop and validate scales measuring common concerns of patients with choroidal melanoma: perception of appearance, concern about cancer recurrence, and difficulty with vision-dependent activities requiring stereopsis or binocularity. DESIGN: Cross-sectional study within a randomized multicenter clinical trial. METHODS: Eight-hundred forty-two of 1317 patients with choroidal melanoma enrolled in the Collaborative Ocular Melanoma Study (COMS) for medium-sized tumors and randomized to receive iodine 125 brachytherapy or enucleation were interviewed. Scale reliability was evaluated using Cronbach's alpha, and validity was investigated through correlation with existing scales and with data collected during COMS clinical examinations. RESULTS: All 3 proposed scales had good internal consistency reliability. The appearance and recurrence scales had low to moderate correlation with the 36-Item Short-Form Health Survey mental health scale (r = 0.26 and 0.31, respectively) and with the the Hospital Anxiety and Depression Scale depression (r = -0.22 and -0.19) and anxiety (r = -0.27 and -0.42) scales. Appearance scores were significantly associated with occurrence of appearance-altering complications and conditions, recurrence scores were associated with recent removal of the brachytherapy-treated eye, and stereopsis/binocularity scores were higher in patients with good visual acuity in both eyes than in those with good visual acuity in one eye and an enucleated fellow eye. CONCLUSIONS: All 3 proposed scales have good internal consistency, range, and SDs of measurement in the tested population. Based on clinical data, there is evidence of good construct validity for all 3 scales, although there also is evidence that the stereopsis/binocularity scale is sensitive to other aspects of vision in addition to stereopsis and binocularity. The appearance and recurrence scales capture clinically relevant information not available from standard mental health scales.

Adult↗
PubMed2003

Two mesalazine regimens in the prevention of the post-operative recurrence of Crohn's disease: a pragmatic, double-blind, randomized controlled trial.

BACKGROUND: The role of mesalazine in preventing the clinical recurrence of Crohn's disease after surgery has been shown in a meta-analysis of all published studies. No clear relationship, however, has been shown between dosage and response. AIM: To evaluate whether 4.0 g/day of mesalazine may offer therapeutic advantages over 2.4 g/day in the prevention of both endoscopic and clinical post-operative recurrence of Crohn's disease. METHODS: The study was a double-blind, randomized, multi-centre, prospective, controlled clinical trial. Two hundred and six patients, submitted to first or second intestinal resection for Crohn's disease limited to the terminal ileum, with or without involvement of the caecum/ascending colon, were enrolled. Of these, 101 were randomly allocated to receive 4.0 g/day of mesalazine (Asacol, Giuliani SpA, Milan, Italy) and 105 to receive 2.4 g/day, starting 2 weeks after surgery. The primary outcome was endoscopic recurrence, at 12 months after surgery. Three different degrees of endoscopic recurrence were evaluated (endoscopic scores: > 0, > 1 and > 2). The secondary outcome was clinical recurrence, defined as a Crohn's disease activity index of more than 150 points or an increase in the Crohn's disease activity index of 100 points or more. For statistical analysis, chi-square, Wilcoxon and Cox regression model tests were used, when appropriate. RESULTS: Eighty-four patients in the 4.0 g/day group and 81 patients in the 2.4 g/day group were evaluable by endoscopy. Endoscopic recurrence of > 0 was significantly higher in the 2.4 g/day group than in the 4.0 g/day group (62% vs. 46%; P < 0.04). No difference was observed between the two groups with regard to the other two endoscopic outcomes (> 1 and > 2) or clinical recurrence. CONCLUSIONS: A 4.0 g/day regimen of mesalazine does not offer a clinically significant advantage over a 2.4 g/day regimen in the prevention of post-operative endoscopic and clinical recurrence of Crohn's disease at 1 year of follow-up.

Administration, Oral↗