Persistent cholestatic jaundice after ERCP.
Explore the source record for details and available documents.
Biomedical subjects
Publications and source records attributed to Peter A L Bonis.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Public and corporate pressure to improve the quality of healthcare in the United States has never been greater. Rising costs, recent discouraging appraisals of patient safety, accelerating malpractice litigation, and an increasing burden of chronic disease have intensified the demand for a change in current policies. Central to these efforts are payers who are increasingly creating financial incentives for providers to deliver high-quality healthcare. It is hoped that these programs (sometimes referred to as "quality incentive payment systems") will stimulate the adoption of systems that will reduce variability and assure that high-quality care is being delivered. Whether these programs will achieve their objectives remains to be determined. There are many unanswered questions about their effectiveness.
Primary biliary cirrhosis frequently progresses despite treatment with ursodeoxycholic acid (UDCA), the only approved therapy. Previous studies suggested that colchicine and methotrexate may improve biochemical tests of liver function, symptoms, and liver histology. The aim of the present study was to determine if the addition of colchicine or methotrexate to UDCA would improve survival free of liver transplantation. Eighty-five patients with histologically confirmed primary biliary cirrhosis whose serum alkaline phosphatase levels were at least twice the normal level and who were not yet candidates for liver transplantation were randomly assigned to receive colchicine or methotrexate in a double-blind study. UDCA was administered to all patients after 2 years. The primary end point was survival free of liver transplantation. Patients were followed up for a total of up to 10 years or until treatment failure. Data were analyzed on an intention-to-treat basis. Transplant-free survival was similar in both groups: 0.57 for colchicine plus UDCA and 0.44 for methotrexate plus UDCA, results that are similar to those predicted by the Mayo prognostic model. Significant improvement in liver biochemical tests and liver histology was observed in a subset of patients in both treatment groups who remained in the study for all 10 years. In conclusion, neither colchcine plus UDCA nor methotrexate plus UDCA improved survival beyond that predicted by the Mayo prognostic model. However, clinical, histologic, and biochemical improvement observed among those who remained in the study for 10 years suggests a possible benefit of these drugs in a subset of patients.
BACKGROUND: Approximately ten percent of patients placed on mechanical ventilation during acute illness will require long-term ventilator support. Unfortunately, despite rehabilitation, some will never be liberated from the ventilator. A method of predicting weaning outcomes for these patients could help conserve resources and minimize frustrating failed weaning attempts for this population. The objective of this investigation was to identify predictors of weaning outcome for patients admitted to a chronic ventilator unit (CVU). METHODS: This was a retrospective analysis with prospective validation. The study setting was a 25 bed CVU within a rehabilitation hospital. The training group consisted of 43 patients referred to our facility for weaning after > 3 weeks of mechanical ventilation. A multivariate model to predict weaning outcome was constructed in this group and applied to a prospective group of 31 patients followed during an 18-month period. RESULTS: A modified Glasgow Coma Scale (GCS) and the presence of sustained spontaneous respirations (SSR), defined as the presence of 2 breaths recorded above the ventilator settings on four occasions, were highly predictive of weaning success within six months of CVU admission. Patients with a modified GCS > or = 8 were 6.5 times more likely to wean than those with a modified GCS < 8 (95% confidence interval 1.6-26.3) and those with SSR were 25.5 times more likely to wean than those without SSR (95% confidence interval 4.3-51.9). CONCLUSIONS: In our population of CVU patients, simple parameters that were available on admission and did not directly reflect cardiopulmonary function were useful predictors of weaning outcome.
OBJECTIVE: To investigate the efficacy of acid suppressant drugs in the empirical treatment of gastroesophageal reflux disease (GERD) and in the treatment of endoscopy-negative reflux disease (ENRD). DESIGN: medline, embase, and the Cochrane Controlled Trials Register were searched. Bibliographies were reviewed. SETTING: Studies were eligible that compared the short-term use of proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) with each other or with placebo in adults with GERD who were enrolled irrespective of endoscopic findings (empirical cases) or in whom endoscopy showed no signs of esophagitis (endoscopy-negative cases). MEASUREMENTS: Of 1,408 studies, only 13 could be included for meta-analysis. Data on 3,433 patients empirically treated for GERD and 2,520 patients treated for ENRD were extracted. The primary endpoint was relief of heartburn. MAIN RESULTS: In the empirical treatment of GERD, the summary relative risk (sRR) for symptom relief from H2RAs versus placebo was 0.77 (95% confidence interval [95% CI], 0.60 to 0.99). RR in the only placebo-controlled PPI trial was 0.35 (95% CI, 0.26 to 0.46). The sRR for standard dose PPIs versus H2RAs was 0.55 (95% CI, 0.44 to 0.68). In treatment of ENRD, both PPIs (sRR, 0.64; 95% CI, 0.52 to 0.79) and H2RAs (sRR, 0.78; 95% CI, 0.62 to 0.97) were superior to placebo, and PPIs were superior to H2RAs (sRR, 0.81; 95% CI, 0.70 to 0.95). CONCLUSIONS: Acid suppressant therapy (with a PPI or an H2RA) is more effective than placebo for short-term relief of heartburn in patients with persistent symptoms who are treated empirically for GERD and in those in whom esophagitis was excluded after endoscopy. The benefit of PPIs compared with H2RAs is more pronounced in patients treated empirically.
CONTEXT: Specific features of trial quality may be associated with exaggeration or shrinking of the observed treatment effect in randomized studies. Therefore, assessment of trial quality is often used in meta-analysis. However, the degree to which specific quality measures are associated with treatment effects has not been well established across a broad range of clinical areas. OBJECTIVE: To determine if quality measures are associated with treatment effect size in randomized controlled trials (RCTs). DESIGN: Quality measures from published quality assessment scales were evaluated in RCTs included in meta-analyses from 4 medical areas (cardiovascular disease, infectious disease, pediatrics, and surgery). Included meta-analyses incorporated at least 6 RCTs, examined dichotomous outcomes, and demonstrated significant between-study heterogeneity in the odds ratio (OR) scale. MAIN OUTCOME MEASURES: Relative ORs comparing overall treatment effect (summary OR) of high vs low-quality studies, as determined by each quality measure, with relative ORs less than 1 indicating larger treatment effect in low-quality studies. RESULTS: Twenty-four quality measures were analyzed for 276 RCTs from 26 meta-analyses. Relative ORs of high vs low-quality studies for these quality measures ranged from 0.83 to 1.26; none was statistically significantly associated with treatment effect. The proportion of studies fulfilling specific quality measures varied widely in the 4 medical areas. In analyses limited to specific medical areas, placebo control, multicenter studies, study country, caregiver blinding, and statistical methods were significantly associated with treatment effect on 7 occasions. These relative ORs ranged from 0.40 to 1.74. However, the directions of these associations were not consistent. CONCLUSIONS: Individual quality measures are not reliably associated with the strength of treatment effect across studies and medical areas. Although use of specific quality measures may be appropriate in specific well-defined areas in which there is pertinent evidence, findings of associations with treatment effect cannot be generalized to all clinical areas or meta-analyses.