Biomedical subjects

Colleen M Brensinger

Publications and source records attributed to Colleen M Brensinger.

23 records · Page 2Linked to original sources

PubMed2004

A meta-analysis of the placebo rates of remission and response in clinical trials of active Crohn's disease.

BACKGROUND & AIMS: Placebo-controlled, randomized clinical trials (PC-RCTs) are commonly used to assess therapies for Crohn's disease (CD). Knowledge of the placebo rates of remission and response and understanding of design factors that influence these rates is important for designing future clinical trials evaluating pharmacotherapy of CD. The aims of this study were to estimate rates of remission and response in patients with active CD receiving placebo and to identify factors influencing these rates. METHODS: We performed a systematic review and meta-analysis of PC-RCTs evaluating therapies for active CD identified from MEDLINE from 1966 to 2001. RESULTS: The pooled estimates of the placebo rates of remission and response were 18% (95% confidence interval, 14%-24%; range, 0%-50%) and 19% (95% confidence interval, 13%-28%; range, 0%-46%), respectively, both with significant heterogeneity among studies (P < 0.01 for remission, P < 0.03 for response). In multivariate models, study duration, number of study visits, and entry Crohn's Disease Activity Index score were important predictors of the placebo remission rate, with study duration the most important. However, no single factor could account for all of the heterogeneity. Factors that influence the placebo response rates were similar to those affecting the placebo remission rates. The absolute benefit of active treatment beyond placebo was generally larger when outcome was measured by response than remission. CONCLUSIONS: Placebo remission and response rates in PC-RCTs for active CD are variable. Study duration, number of study visits, and disease severity at entry have a large influence on placebo remission rates.

Controlled Clinical Trials as Topic↗

PubMed2004

Endoscopic management of biliary complications after adult living donor liver transplantation.

OBJECTIVES: Biliary complications and their treatment in adult cadaveric liver transplantation (CLT) are well described. However, biliary complications and their management in living donor liver transplantation (LDLT) are not well characterized. We assessed the role of endoscopic retrograde cholangiopancreatography (ERCP) in the diagnosis and management of biliary complications following LDLT. METHODS: We performed a retrospective cohort analysis of all LDLT recipients with duct-to-duct anastomoses (n = 15). Specific data included referral for ERCP, diagnosis, and therapy. Comparisons were made to a 260 CLT recipient cohort. RESULTS: Greater percentage of LDLT recipients underwent ERCP (73%) compared to CLT recipients (25%; p= 0.001). Biliary complications diagnosed by ERCP in LDLT recipients consisted of bile leaks and strictures, and were more frequent than in CLT recipients (leaks: 53%vs 12%; p= 0.001; strictures: 27%vs 5%; p= 0.01). Most leaks occurred at T-tube sites (LDLT: 87%; CLT: 65%). Diagnosis and therapy of leaks required a median of 2 ERCP procedures in both groups. Bile leaks were successfully treated endoscopically in 100% and 84% of LDLT and CLT recipients, respectively (p= 0.56). Most biliary strictures were anastomotic (LDLT: 100%; CLT: 64%). Strictures were diagnosed and treated with a median of 1.5 and 2 ERCP procedures in the LDLT and CLT groups, respectively. The duration of endoscopic therapy was a median of 10 and 14 wk, and success rates were 75% and 62% (p= 1.0) in LDLT and CLT groups, respectively. CONCLUSIONS: LDLT is associated with increased biliary complications as compared to CLT. ERCP is useful for diagnosis, can successfully treat most LDLT-related biliary complications, and should be attempted prior to more invasive interventions.

Adolescent↗

PubMed2004

Criteria for improvement in rheumatoid arthritis: alternatives to the American College of Rheumatology 20.

OBJECTIVE: Appropriate outcome measures are critical to estimating treatment effects in clinical trials and observational studies. The American College of Rheumatology 20 (ACR 20) is the standard measure to assess treatment effects in rheumatoid arthritis (RA) randomized controlled clinical trials (RCT). Although the ACR 20, which measures at least a 20% improvement in a number of different measures, is a very useful dichotomous measure for identifying novel treatments with potential activity, it may fail to discriminate among active treatments. In an effort to increase stringency, trials have used the ACR at 50% and 70%. We investigated the behavior of these and other scoring systems to quantify treatment outcome in several RCT in RA. METHODS: The Cooperating Clinics for the Systematic Study of Rheumatic Disease (CSSRD) database contained 2 trials with a total of 6 arms. Using raw data for each patient entered, we calculated ACR 20, 50, and 70 for each arm. We also calculated the average number of criteria met for the ACR 20, 50, and 70 and their respective areas under the curve over time. RESULTS: The ACR 20 failed to discriminate among active therapies; however, the ACR 50 was too stringent, and only one patient in these trials satisfied the ACR 70. The average number of criteria satisfied at the 50% level at the final trial visit discriminated well, as did the area under the curve. CONCLUSION: The average number of ACR criteria met at a 20% or 50% level discriminated better than the traditional ACR criteria in these trials. More of the information is preserved by the area under the curve of the number of ACR criteria satisfied at each level because area preserves both the number of criteria and the time dependence. The area under the curve of the number of ACR criteria met is a discriminatory, specific, time-dependent, responsive, and domain-preserving metric to use as the primary outcome measure in trials of agents for the treatment of RA. These conclusions should be tested in additional data sets.

Antirheumatic Agents↗

PubMed2003

Biliary casts after orthotopic liver transplantation: clinical factors, treatment, biochemical analysis.

OBJECTIVES: Biliary casts develop in up to 18% of liver transplant recipients. Casts are associated with morbidity, graft failure, need for retransplantation, and mortality. Proposed etiological mechanisms include acute cellular rejection, ischemia, infection, and biliary obstruction. We aimed to identify clinical features associated with biliary cast formation, review treatments, and analyze the biochemical composition of casts at a single, large, liver transplant center. METHODS: Patient records were reviewed retrospectively to identify patients who developed casts. Data were collected with attention to ischemia, rejection, obstruction, infection, immunosuppression, postoperative biliary drain use, and cast-directed management, and were compared with data from controls. Cast specimens, retrieved at cholangiography, were analyzed with chromatography techniques. RESULTS: Ischemic factors were noted in 70% (7/10) of cast patients versus 15% (6/40) of controls (OR = 13.2; 95% CI = 2.7-66.0; p = 0.001). Biliary strictures were present in 50% of cast patients versus 10% of controls (OR = 9.0; 95% CI = 1.8-45.2; p = 0.01). Differences in cold ischemia time, acute cellular rejection, cyclosporin use, infection, and postoperative biliary drain use were not significant. Casts were successfully treated by endoscopic and percutaneous methods in 60% of patients. One patient died of cast-related complications (mortality 10%). Four casts were in satisfactory condition for biochemical analysis. Bilirubin was the main component ( approximately 10-50%). Bile acid synthesis products and cholesterol comprised smaller percentages, and protein comprised only 5-10%. CONCLUSIONS: Biliary casts are more likely to develop in the setting of hepatic ischemia and biliary strictures. Endoscopic and percutaneous cast extraction might achieve favorable results and should be attempted before surgical therapy.

Adult↗

PubMed2003

Facial emotion recognition in schizophrenia: intensity effects and error pattern.

OBJECTIVE: The authors used color photographs of emotional and neutral expressions to investigate recognition patterns of five universal emotions in schizophrenia. METHOD: Twenty-eight stable outpatients with schizophrenia (19 men and nine women) and 61 healthy subjects (29 men and 32 women) completed an emotion discrimination test that presented mild and extreme intensities of happy, sad, angry, fearful, disgusted, and neutral faces, balanced for gender and ethnicity. Analyses evaluated accuracy of identifying emotions as a function of intensity, diagnosis, and gender of poser and rater. RESULTS: Patients performed worse than comparison subjects on recognition of all emotions and neutral faces combined, including mild and extreme expressions. For specific emotions, patients performed worse on recognition of fearful, disgusted, and neutral expressions. For all emotions except disgust, recognition of extreme intensity was better than recognition of mild intensity. However, patients showed less benefit from increased intensity for all emotions combined, and the difference was most pronounced for fear. Thus, patients were more impaired than healthy comparison subjects in identifying high-intensity expressions, even though this was an easier task than identifying low-intensity expressions. In the comparison of patterns of errors, patients and healthy subjects differed only in misattributions of neutral expressions; patients overattributed disgusted expressions and underattributed happy expressions. CONCLUSIONS: Patients with schizophrenia were impaired in overall emotion recognition, particularly fear and disgust, and did not benefit from increased emotional intensity. Error patterns indicate that patients misidentified neutral cues as negatively valenced.

Adult↗